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1.
  • Lind, Marcus, 1976, et al. (author)
  • Glycemic control and excess mortality in type 1 diabetes
  • 2014
  • In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 371:21, s. 1972-1982
  • Journal article (peer-reviewed)abstract
    • Copyright © 2014 Massachusetts Medical Society. All rights reserved. BACKGROUND: The excess risk of death from any cause and of death from cardiovascular causes is unknown among patients with type 1 diabetes and various levels of glycemic control. We conducted a registry-based observational study to determine the excess risk of death according to the level of glycemic control in a Swedish population of patients with diabetes. METHODS: We included in our study patients with type 1 diabetes registered in the Swedish National Diabetes Register after January 1, 1998. For each patient, five controls were randomly selected from the general population and matched according to age, sex, and county. Patients and controls were followed until December 31, 2011, through the Swedish Register for Cause-Specific Mortality. RESULTS: The mean age of the patients with diabetes and the controls at baseline was 35.8 and 35.7 years, respectively, and 45.1% of the participants in each group were women. The mean follow-up in the diabetes and control groups was 8.0 and 8.3 years, respectively. Overall, 2701 of 33,915 patients with diabetes (8.0%) died, as compared with 4835 of 169,249 controls (2.9%) (adjusted hazard ratio, 3.52; 95% confidence interval [CI], 3.06 to 4.04); the corresponding rates of death from cardiovascular causes were 2.7% and 0.9% (adjusted hazard ratio, 4.60; 95% CI, 3.47 to 6.10). The multivariable-adjusted hazard ratios for death from any cause according to the glycated hemoglobin level for patients with diabetes as compared with controls were 2.36 (95% CI, 1.97 to 2.83) for a glycated hemoglobin level of 6.9% or lower (≤52 mmol per mole), 2.38 (95% CI, 2.02 to 2.80) for a level of 7.0 to 7.8% (53 to 62 mmol per mole), 3.11 (95% CI, 2.66 to 3.62) for a level of 7.9 to 8.7% (63 to 72 mmol per mole), 3.65 (95% CI, 3.11 to 4.30) for a level of 8.8 to 9.6% (73 to 82 mmol per mole), and 8.51 (95% CI, 7.24 to 10.01) for a level of 9.7% or higher (≥83 mmol per mole). Corresponding hazard ratios for death from cardiovascular causes were 2.92 (95% CI, 2.07 to 4.13), 3.39 (95% CI, 2.49 to 4.61), 4.44 (95% CI, 3.32 to 5.96), 5.35 (95% CI, 3.94 to 7.26), and 10.46 (95% CI, 7.62 to 14.37). CONCLUSIONS: In our registry-based observational study, patients with type 1 diabetes and a glycated hemoglobin level of 6.9% or lower had a risk of death from any cause or from cardiovascular causes that was twice as high as the risk for matched controls.
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  • Barbu, Mikael, et al. (author)
  • Hemostatic effects of a dextran-based priming solution for cardiopulmonary bypass: A secondary analysis of a randomized clinical trial
  • 2023
  • In: Thrombosis Research. - : Elsevier BV. - 0049-3848. ; 223, s. 139-145
  • Journal article (peer-reviewed)abstract
    • Introduction: Intravascular fluids administered to patients may influence hemostasis. In patients undergoing cardiac surgery with cardiopulmonary bypass, the heart-lung machine is primed with 1300 ml of fluid. We assessed postoperative coagulation and platelet function in patients randomized to two different priming solu-tions, one colloid-based (dextran 40) and one crystalloid-based.Materials and methods: Eighty-four elective cardiac surgery patients were randomized to either a dextran-based prime or Ringer's acetate with added mannitol. Blood samples were collected before, and 2 and 24 h after cardiopulmonary bypass. Coagulation was assessed by standard coagulation tests and rotational thromboelas-tometry. Platelet function was assessed with impedance aggregometry. Bleeding volumes and transfusion re-quirements were recorded.Results: Comparing the groups 2 h after bypass, the dextran group showed lower hemoglobin concentration, hematocrit, platelet count, and fibrinogen concentration, and higher INR and aPTT, as well as longer clot for-mation time (+41 +/- 21 % vs. +8 +/- 18 %, p < 0.001) and a larger reduction in fibrinogen-dependent clot strength (-37 +/- 12 % vs.-7 +/- 20 %, p < 0.001). Adenosine diphosphate-dependent platelet activation was reduced in the dextran group but not in the crystalloid group 2 h after bypass (-14 +/- 29 % vs.-1 +/- 41 %, p = 0.041). No significant between-group differences in hemostatic variables remained after 24 h, and no significant differences in perioperative bleeding volumes, re-explorations for bleeding, or transfusion rates were observed.Conclusions: Compared to a crystalloid solution, a dextran-based prime had measurable negative impact on he-mostatic variables but no detectable increase in bleeding volume or transfusion requirements in cardiac surgery patients.
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4.
  • Dahlqvist, S., et al. (author)
  • Risk of atrial fibrillation in people with type 1 diabetes compared with matched controls from the general population: a prospective case-control study
  • 2017
  • In: Lancet Diabetes & Endocrinology. - : Elsevier BV. - 2213-8587. ; 5:10, s. 799-807
  • Journal article (peer-reviewed)abstract
    • Background Type 1 diabetes is associated with an increased risk of developing several cardiovascular complications. To our knowledge, the independent association between type 1 diabetes and atrial fibrillation has not been studied. Methods We did a prospective case-control study of individuals with type 1 diabetes in the Swedish National Diabetes Registry who were each matched with five controls for age, sex, and county of residence who were randomly selected from the Swedish Population Register. Cases of atrial fibrillation were obtained from the Swedish National Patient Registry. Findings We followed up 36 258 patients with type 1 diabetes and 179 980 controls between Jan 1, 2001, and Dec 31, 2013. Median follow-up was 9.7 years (IQR 5.2-13.0) for patients and 10.2 years (5.7-13.0) for controls. 749 (2%) individuals with type 1 diabetes and 2882 (2%) controls were diagnosed with atrial fibrillation, with an adjusted hazard ratio (HR) of 1.13 (95% CI 1.01-1.25; p = 0.029) in men and 1.50 (1.30-1.72; p < 0.0001) in women (p = 0.0019 for interaction). The excess risk of atrial fibrillation in individuals with type 1 diabetes increased with worsening glycaemic control and renal complications. Among individuals with normoalbuminuria, no excess risk of atrial fibrillation was noted in men with type 1 diabetes who had HbA(1c) lower than 9.7% (< 83 mmol/mol) or in women with type 1 diabetes who had HbA(1c) lower than 8.8% (< 73 mmol/mol). Interpretation Compared with the general population, the risk of atrial fibrillation in men with type 1 diabetes was slightly raised, whereas for female patients it was 50% higher. The risk of atrial fibrillation in people with type 1 diabetes increased with renal complications and poor glycaemic control.
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7.
  • Hedén Ståhl, Christina, 1972, et al. (author)
  • Long-term excess risk of stroke in people with Type 2 diabetes in Sweden according to blood pressure level: a population-based case-control study
  • 2017
  • In: Diabetic medicine : a journal of the British Diabetic Association. - : Wiley. - 1464-5491 .- 0742-3071. ; 34:4, s. 522-530
  • Journal article (peer-reviewed)abstract
    • AIMS: To estimate the risk of stroke in people with Type 2 diabetes with different blood pressure levels compared with the risk in the general population in Sweden. METHODS: This prospective case-control study included 408 076 people with Type 2 diabetes, aged >/=18 years, and free of prior stroke, registered in the Swedish National Diabetes Register 1998-2011. Age- and sex-matched control subjects (n=1 913 507) without stroke from the general population were included. Stroke diagnoses were retrieved using International Classification of Disease codes from the Swedish patient and death registers. Cox hazard ratios and 95% confidence intervals (CIs) were estimated at six different blood pressure levels. RESULTS: During a median follow-up of 4 years, 19 548 (4.8%) people with Type 2 diabetes and 61 690 (3.2%) without diabetes were diagnosed with stroke, corresponding to an adjusted hazard ratio of 1.43 (95% CI 1.41-1.46) for people with Type 2 diabetes as a group. Compared with people without diabetes, the risk of stroke for people with Type 2 diabetes with different blood pressure levels was significantly higher, starting at blood pressure levels >130/80 mmHg. Hazard ratios for stroke were 1.20 (95% CI 1.16-1.24), 1.47 (95% CI 1.43-1.50), and 1.97 (95% CI 1.90-2.03) for blood pressure categories of 130-139/80-89 mmHg, 140-159/90-99 mmHg and >/=160/>/=100 mmHg, respectively, after adjustment for age, sex, diabetes duration, being born in Sweden, maximum education level and baseline comorbidities. CONCLUSIONS: People with Type 2 diabetes and blood pressure < 130/80 mmHg had a risk of stroke similar to that of the general population. This article is protected by copyright. All rights reserved.
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8.
  • Lind, Marcus, 1976, et al. (author)
  • Changes in HbA(1c) and frequency of measuring HbA(1c) and adjusting glucose-lowering medications in the 10 years following diagnosis of type 2 diabetes: a population-based study in the UK
  • 2014
  • In: Diabetologia. - : Springer Science and Business Media LLC. - 0012-186X .- 1432-0428. ; 57:8, s. 1586-1594
  • Journal article (peer-reviewed)abstract
    • Aim/hypothesis The aim of this work was to study levels of HbA(1c) and patterns of adjusting glucose-lowering drugs in patients with impaired glycaemic control over 10 years after diagnosis of type 2 diabetes. Methods We studied 4,529 individuals in The Health Improvement Network Database newly diagnosed with type 2 diabetes in the year 2000. Results From 6 months to 10 years after diagnosis, the HbA(1c) increased from 7.04% (53.4 mmol/mol) to 7.49% (58.3 mmol/mol) (average annual change: 0.047% [0.51 mmol/mol]). The greatest annual change occurred between 6 months and 2 years (0.21% [2.30 mmol/mol] increase per year, p < 0.001), followed by the 2-5 year time period (0.033% [0.36 mmol/mol] increase per year, p < 0.001). No significant increase in HbA(1c) occurred between 5 and 10 years (p = 0.20). In multivariable analyses, patients who were younger (p < 0.001), with higher BMI (p = 0.033) and who were current insulin users (p = 0.024) at diagnosis had greater increases in HbA(1c) between 6 months and 2 years. For individuals with HbA(1c) above 7.0% (53 mmol/mol) the mean time to next measurement of HbA(1c) was 0.53 years and increase in doses or changes to other glucose-lowering medications were performed in 26% of cases. Conclusions/interpretation HbA(1c) increases by approximately 0.5% (5 mmol/mol) over 10 years after diagnosis of type 2 diabetes, with the main increase appearing in the first years after diagnosis. More frequent monitoring of HbA(1c) and adjustments of glucose-lowering drugs may be essential to prevent the decline.
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  • Matuleviciene Anängen, Viktorija, et al. (author)
  • Glycaemic control and excess risk of major coronary events in persons with type 1 diabetes
  • 2017
  • In: Heart. - : BMJ. - 1355-6037 .- 1468-201X. ; 103:21, s. 1687-1695
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: The excess risk of major coronary events (acute myocardial infarction (AMI) or death from coronary heart disease (CHD)) in individuals with type 1 diabetes (T1D) in relation to glycaemic control and renal complications is not known. METHODS: Individuals with T1D in the Swedish National Diabetes Registry after 1 January 1998, without a previous MI (n=33 170) and 1 64 698 controls matched on age, sex and county were followed with respect to non-fatal AMI or death from CHD. Data were censored at death due to any cause until 31 December 2011. RESULTS: During median follow-up of 8.3 and 8.9 years for individuals with T1D and controls, respectively, 1500 (4.5%) and 1925 (1.2%), experienced non-fatal AMI or died from CHD, adjusted HR 4.07 (95% CI 3.79 to 4.36). This excess risk increased with younger age, female sex, worse glycaemic control and severity of renal complications.The adjusted HR in men with T1D with updated mean haemoglobin A1c (HbA1c) <6.9% (52 mmol/mol) and normoalbuminuria was 1.30 (95% CI 0.90 to 1.88) and in women 3.16 (95% CI 2.14 to 4.65). HRs increased to 10.7 (95% CI 8.0 to 14.3) and 31.8 (95% CI 23.6 to 42.8) in men and women, respectively, with HbA1c >9.7% and renal complications. CONCLUSIONS: The excess risk of AMI in T1D is substantially lower with good glycaemic control, absence of renal complications and men compared with women. In women, the excess risk of AMI or CHD death persists even among patients with good glycaemic control and no renal complications.
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10.
  • Pivodic, Aldina, 1978, et al. (author)
  • Development and validation of a new clinical decision support tool to optimize screening for retinopathy of prematurity
  • 2022
  • In: British Journal of Ophthalmology. - : BMJ Publishing Group Ltd. - 0007-1161 .- 1468-2079. ; 106:11, s. 1573-1580
  • Journal article (peer-reviewed)abstract
    • BACKGROUND/AIMS: Prematurely born infants undergo costly, stressful eye examinations to uncover the small fraction with retinopathy of prematurity (ROP) that needs treatment to prevent blindness. The aim was to develop a prediction tool (DIGIROP-Screen) with 100% sensitivity and high specificity to safely reduce screening of those infants not needing treatment. DIGIROP-Screen was compared with four other ROP models based on longitudinal weights.METHODS: Data, including infants born at 24-30 weeks of gestational age (GA), for DIGIROP-Screen development (DevGroup, N=6991) originate from the Swedish National Registry for ROP. Three international cohorts comprised the external validation groups (ValGroups, N=1241). Multivariable logistic regressions, over postnatal ages (PNAs) 6-14 weeks, were validated. Predictors were birth characteristics, status and age at first diagnosed ROP and essential interactions.RESULTS: ROP treatment was required in 287 (4.1%)/6991 infants in DevGroup and 49 (3.9%)/1241 in ValGroups. To allow 100% sensitivity in DevGroup, specificity at birth was 53.1% and cumulatively 60.5% at PNA 8 weeks. Applying the same cut-offs in ValGroups, specificities were similar (46.3% and 53.5%). One infant with severe malformations in ValGroups was incorrectly classified as not needing screening. For all other infants, at PNA 6-14 weeks, sensitivity was 100%. In other published models, sensitivity ranged from 88.5% to 100% and specificity ranged from 9.6% to 45.2%.CONCLUSIONS: DIGIROP-Screen, a clinical decision support tool using readily available birth and ROP screening data for infants born GA 24-30 weeks, in the European and North American populations tested can safely identify infants not needing ROP screening. DIGIROP-Screen had equal or higher sensitivity and specificity compared with other models. DIGIROP-Screen should be tested in any new cohort for validation and if not validated it can be modified using the same statistical approaches applied to a specific clinical setting.
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  • Pivodic, Aldina, 1978, et al. (author)
  • Validation of DIGIROP models and decision support tool for prediction of treatment for retinopathy of prematurity on a contemporary Swedish cohort
  • 2023
  • In: British Journal of Ophthalmology. - : BMJ. - 0007-1161 .- 1468-2079. ; 107:8, s. 1132-1138
  • Journal article (peer-reviewed)abstract
    • Background/Aims Retinopathy of prematurity (ROP) is currently diagnosed through repeated eye examinations to find the low percentage of infants that fulfil treatment criteria to reduce vision loss. A prediction model for severe ROP requiring treatment that might sensitively and specifically identify infants that develop severe ROP, DIGIROP-Birth, was developed using birth characteristics. DIGIROP-Screen additionally incorporates first signs of ROP in different models over time. The aim was to validate DIGIROP-Birth, DIGIROP-Screen and their decision support tool on a contemporary Swedish cohort. Methods Data were retrieved from the Swedish national registry for ROP (2018-2019) and two Swedish regions (2020), including 1082 infants born at gestational age (GA) 24 to <31 weeks. The predictors were GA at birth, sex, standardised birth weight and age at the first sign of ROP. The outcome was ROP treatment. Sensitivity, specificity and area under the receiver operating characteristic curve (AUC) with 95% CI were described. Results For DIGIROP-Birth, the AUC was 0.93 (95% CI 0.90 to 0.95); for DIGIROP-Screen, it ranged between 0.93 and 0.97. The specificity was 49.9% (95% CI 46.7 to 53.0) and the sensitivity was 96.5% (95% CI 87.9 to 99.6) for the tool applied at birth. For DIGIROP-Screen, the cumulative specificity ranged between 50.0% and 78.7%. One infant with Beckwith-Wiedemann syndrome who fulfilled criteria for ROP treatment and had no missed/incomplete examinations was incorrectly flagged as not needing screening. Conclusions DIGIROP-Birth and DIGIROP-Screen showed high predictive ability in a contemporary Swedish cohort. At birth, 50% of the infants born at 24 to <31 weeks of gestation were predicted to have low risk of severe ROP and could potentially be released from ROP screening examinations. All routinely screened treated infants, excluding those screened for clinical indications of severe illness, were correctly flagged as needing ROP screening.
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  • Tancredi, Mauro, et al. (author)
  • Excess Mortality among Persons with Type 2 Diabetes
  • 2015
  • In: New England Journal of Medicine. - 0028-4793. ; 373:18, s. 1720-1732
  • Journal article (peer-reviewed)abstract
    • BACKGROUND The excess risks of death from any cause and death from cardiovascular causes among persons with type 2 diabetes and various levels of glycemic control and renal complications are unknown. In this registry-based study, we assessed these risks according to glycemic control and renal complications among persons with type 2 diabetes. We included patients with type 2 diabetes who were registered in the Swedish National Diabetes Register on or after January 1, 1998. For each patient, five controls were randomly selected from the general population and matched according to age, sex, and county. All the participants were followed until December 31, 2011, in the Swedish Registry for Cause-Specific Mortality. The mean follow-up was 4.6 years in the diabetes group and 4.8 years in the control group. Overall, 77,117 of 435,369 patients with diabetes (17.7%) died, as compared with 306,097 of 2,117,483 controls (14.5%) (adjusted hazard ratio, 1.15; 95% confidence interval [CI], 1.14 to 1.16). The rate of cardiovascular death was 7.9% among patients versus 6.1% among controls (adjusted hazard ratio, 1.14; 95% CI, 1.13 to 1.15). The excess risks of death from any cause and cardiovascular death increased with younger age, worse glycemic control, and greater severity of renal complications. As compared with controls, the hazard ratio for death from any cause among patients younger than 55 years of age who had a glycated hemoglobin level of 6.9% or less (<= 52 mmol per mole of nonglycated hemoglobin) was 1.92 (95% CI, 1.75 to 2.11); the corresponding hazard ratio among patients 75 years of age or older was 0.95 (95% CI, 0.94 to 0.96). Among patients with normoalbumin-uria, the hazard ratio for death among those younger than 55 years of age with a glycated hemoglobin level of 6.9% or less, as compared with controls, was 1.60 (95% CI, 1.40 to 1.82); the corresponding hazard ratio among patients 75 years of age or older was 0.76 (95% CI, 0.75 to 0.78), and patients 65 to 74 years of age also had a significantly lower risk of death (hazard ratio, 0.87; 95% CI, 0.84 to 0.91). Mortality among persons with type 2 diabetes, as compared with that in the general population, varied greatly, from substantial excess risks in large patient groups to lower risks of death depending on age, glycemic control, and renal complications. (Funded by the Swedish government and others.)
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  • Vestberg, Daniel, et al. (author)
  • Investigation of early signs of systolic and diastolic dysfunction among persons with type 1 diabetes
  • 2019
  • In: Open Heart. - : BMJ. - 2053-3624. ; 6:2
  • Journal article (peer-reviewed)abstract
    • Background Persons with type 1 diabetes have a higher risk to develop heart failure than the general population, and the mechanism behind the increased risk is unclear. In epidemiological studies with hospitalisation for heart failure as endpoint HbA1c, body mass index and decreased kidney function are significant risk factors, but it is unclear how these risk factors influence the development of heart failure. Methods In this study, we investigated early signs of systolic and diastolic dysfunction with transthoracic echocardiography. Statistical analysis on correlation of risk factors and early signs of diastolic and systolic dysfunction was made. Results In this study population of 287 persons with type 1 diabetes, 160 were men and 127 were women with a mean age of 53.8 (SD 11.6) years and a mean diabetes duration of 36.2 (SD 13.5) years. There were 23 (8.2%) persons who fulfilled the definition of systolic dysfunction (ejection fraction <50%or regional wall motion abnormalities) and 24 persons (9%) the definition for diastolic dysfunction. When comparing the groups with either systolic or diastolic dysfunction to the rest of the population, the only significant risk factor was age in both groups and previous myocardial infarction in the systolic group. Conclusion In our study population with type 1 diabetes, we found signs of diastolic dysfunction in 9% and systolic dysfunction in 8.2%. Compared with published data from the general population, this rate is somewhat higher in a younger population. Only age was a significant risk factor in the study.
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  • Öhman, Annika, et al. (author)
  • Transplantation-free survival after Norwood surgery for hypoplastic left heart syndrome with aortic atresia: A Swedish national cohort study
  • 2020
  • In: Cardiology in the Young. - : Cambridge University Press (CUP). - 1047-9511 .- 1467-1107. ; 30:3
  • Journal article (peer-reviewed)abstract
    • Background: Norwood surgery has been available in Sweden since 1993. In this national cohort study, we analysed transplantation-free survival after Norwood surgery for hypoplastic left heart syndrome with aortic atresia. Methods: Patients were identified from the complete national cohort of live-born with hypoplastic left heart syndrome/aortic atresia 1993-2010. Analysis of survival after surgery was performed using Cox proportional hazards models for the total cohort and for birth period and gender separately. Thirty-day mortality and inter-stage mortality were analysed. Patients were followed until September 2016. Results: The 1993-2010 cohort consisted of 208 live-born infants. Norwood surgery was performed in 121/208 (58%). The overall transplantation-free survival was 61/121 (50%). The survival was higher in the late period (10-year survival 63%) than in the early period (10-year survival 40%) (p = 0.010) and lower for female (10-year survival 34%) than for male patients (10-year survival 59%) (p = 0.002). Inter-stage mortality between stages I and II decreased from 23 to 8% (p = 0.008). For male patients, low birthweight in relation to gestational age was a factor associated with poor outcome. Conclusion: The survival after Norwood surgery for hypoplastic left heart syndrome/aortic atresia improved by era of surgery, mainly explained by improved survival between stages I and II. Female gender was a significant risk factor for death or transplantation. For male patients, there was an increased risk of death when birthweight was lower than expected in relation to gestational age.
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  • Ahlén, Elsa, 1990, et al. (author)
  • Glycemic control, renal complications, and current smoking in relation to excess risk of mortality in persons with type 1 diabetes
  • 2016
  • In: Journal of Diabetes Science and Technology. - : SAGE Publications. - 1932-2968. ; 10:5, s. 1006-1014
  • Journal article (peer-reviewed)abstract
    • Abstract Background: A substantial excess risk of mortality still exists in persons with type 1 diabetes. The aim of this study was to evaluate the excess risk of mortality in persons with type 1 diabetes without renal complications who target goals for glycemic control and are nonsmokers. Furthermore, we evaluated risk factors of death due to hypoglycemia or ketoacidosis in young adults with type 1 diabetes. Methods: We evaluated a cohort based on 33 915 persons with type 1 diabetes and 169 249 randomly selected controls from the general population matched on age, sex, and county followed over a mean of 8.0 and 8.3 years, respectively. Hazard ratios (HRs) for all-cause and cardiovascular disease (CVD) mortality for persons with type 1 diabetes versus controls were estimated. Results: The adjusted HRs for all-cause and CVD mortality for persons with type 1 diabetes without renal complications (normoalbuminuria and eGFR ≥ 60 ml/min) and HbA1c ≤ 6.9% (52 mmol/mol) compared to controls were 1.22 (95% CI 0.98-1.52) and 1.03 (95% CI 0.66-1.60), respectively. The HRs increased with higher updated mean HbA1c. For nonsmokers in this group, the HRs for all-cause and CVD mortality were somewhat lower: 1.11 (95% CI 0.87-1.42) and 0.89 (95% CI 0.53-1.48) at updated mean HbA1c ≤ 6.9% (52 mmol/mol). HRs for significant predictors for deaths due to hypoglycemia or ketoacidosis in persons < 50 years were male sex 2.40 (95% CI 1.27-4.52), smoking 2.86 (95% CI 1.57-5.22), lower educational level 3.01 (95% CI 1.26-7.22), albuminuria or advanced kidney disease 2.83 (95% CI 1.63-4.93), earlier hospital diagnosis of hypoglycemia or ketoacidosis 2.30 (95% CI 1.20-4.42), and earlier diagnosis of intoxication 2.53 (95% CI 1.06-6.04). Conclusions: If currently recommended HbA1c targets can be reached, renal complications and smoking avoided in persons with type 1 diabetes, the excess risk of mortality will likely converge substantially to that of the general population.
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  • Ahmadi, Shilan Seyed, et al. (author)
  • Risk factors for nephropathy in persons with type 1 diabetes: a population-based study
  • 2022
  • In: Acta Diabetologica. - : Springer Science and Business Media LLC. - 0940-5429 .- 1432-5233. ; 59, s. 761-772
  • Journal article (peer-reviewed)abstract
    • Aims Albuminuria is strongly associated with risk of renal dysfunction, cardiovascular disease and mortality. However, clinical guidelines diverge, and evidence is sparse on what risk factor levels regarding blood pressure, blood lipids and BMI are needed to prevent albuminuria in adolescents and young adults with type 1 diabetes. Methods A total of 9347 children and adults with type 1 diabetes [mean age 15.3 years and mean diabetes duration 1.4 years at start of follow-up] from The Swedish National Diabetes Registry were followed from first registration until end of 2017. Levels for risk factors for a risk increase in nephropathy were evaluated, and the gradient of risk per 1 SD (standard deviation) was estimated to compare the impact of each risk factor. Results During the follow-up period, 8610 (92.1%) remained normoalbuminuric, 737 (7.9%) individuals developed micro- or macroalbuminuria at any time period of whom 132 (17.9% of 737) individuals developed macroalbuminuria. Blood pressure >= 140/80 mmHg was associated with increased risk of albuminuria (p <= 0.0001), as were triglycerides >= 1.0 mmol/L (p = 0.039), total cholesterol >= 5.0 mmol/L (p = 0.0003), HDL < 1.0 mmol/L (p = 0.013), LDL 3.5- < 4.0 mmol/L (p = 0.020), and BMI >= 30 kg/m(2) (p = 0.033). HbA1c was the strongest risk factor for any albuminuria estimated by the measure gradient of risk per 1 SD, followed by diastolic blood pressure, triglycerides, systolic blood pressure, cholesterol and LDL. In patients with HbA1c > 65 mmol/mol (> 8.1%), blood pressure > 140/70 mmHg was associated with increased risk of albuminuria. Conclusions Preventing renal complications in adolescents and young adults with type 1 diabetes need avoidance at relatively high levels of blood pressure, blood lipids and BMI, whereas very tight control is not associated with further risk reduction. For patients with long-term poor glycaemic control, stricter blood pressure control is advocated.
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  • Anderson, J., et al. (author)
  • Effect on glycemic control by short- and long-term use of continuous glucose monitoring in clinical practice
  • 2011
  • In: Journal of diabetes science and technology. - : SAGE Publications. - 1932-2968. ; 5:6, s. 1472-9
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: In Sweden, patients with diabetes mellitus frequently receive short-term (<3 months) continuous glucose monitoring (CGM) to study glucose patterns or long-term CGM to treat poor glycemic control or severe hypoglycemia. The effects of CGM on glycemic control in clinical practice in relation to indication and duration of use has not been completely studied. METHODS: Patients with diabetes, among which 99% were diagnosed as type 1, receiving CGM at 10 outpatient clinics in Sweden were studied retrospectively. Long-term use of CGM was defined as >/= 3 months use of CGM and short-term as <3 months. A control group matched on start date and date of latest value 3 months after the start was selected for both long- and short-term groups. RESULTS: In 34 long-term users of CGM, over a mean follow-up of 1.1 years, the adjusted mean difference of hemoglobin A1c (HbA1c) compared with controls (n = 408) was -0.76 (95% confidence interval -1.17; -0.33, p < .001). Long-term users with indications for high HbA1c (n = 15) had a reduction of 1.2% in HbA1c from 10.1 to 8.9% (p = .003), whereas patients with hypoglycemia as their indication (n = 16) decreased by 0.3% (p = .17). Nonsevere hypoglycemic events decreased in long-term users within the same follow-up period (p = .004). Short-term users showed no statistically significant improvement in HbA1c compared with controls at 1.1 years (n = 41), p = .85 or at 2.6 years (n = 43), p = .19. CONCLUSION: Long-term CGM use was associated with improved glycemic control in clinical practice and a reduction in nonsevere hypoglycemic events, whereas short-term use had no effect on HbA1c. The effect on glycemic control varied by indication.
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18.
  • Carlsson, Britt-Marie, et al. (author)
  • Insulin Pump-Long-Term Effects on Glycemic Control: An Observational Study at 10 Diabetes Clinics in Sweden
  • 2013
  • In: Diabetes Technology & Therapeutics. - : Mary Ann Liebert Inc. - 1520-9156 .- 1557-8593. ; 15:4, s. 302-307
  • Journal article (peer-reviewed)abstract
    • Aim: This study examined long-term effects of continuous subcutaneous insulin infusion (CSII) in clinical practice on glycemic control in patients with type 1 diabetes. Subjects and Methods: We evaluated all type 1 diabetes patients at 10 diabetes outpatient clinics in Sweden who had been treated with CSII for at least 5.5 years and had valid glycated hemoglobin (HbA1c) data before starting pump use and at 5 years±6 months. Controls treated with multiple daily insulin injections (MDI) over a time-matched period were also evaluated. Results: There were 331 patients treated with CSII at least 5.5 years at the 10 clinics. Of these, 272 (82%) fulfilled the inclusion criteria. Patients treated with CSII were younger than those treated with MDI (mean age, 38.6 vs. 45.6 years; P<0.001), more were women (56% vs. 43%; P<0.001), and diabetes duration was shorter (mean, 15.1 years vs. 20.1 years; P<0.001). After adjusting for variables differing at baseline and influencing the change in HbA1c over the study period, the reduction in HbA1c remained statistically significant at 5 years and was estimated to be 0.20% (95% confidence interval [CI] 0.07–0.32) (2.17mmol/mol [95% CI 0.81–3.53]) (P=0.002). The corresponding adjusted reduction at years 1 and 2 was 0.42% (95% CI 0.31–0.53) (4.59mmol/mol [95% CI 3.41–5.77]) (P<0.001) and 0.43% (95% CI 0.31–0.55) (4.71mmol/mol [95% CI 3.38–6.04]) (P<0.001), respectively. The effect of insulin pump use versus controls on HbA1c decreased significantly with time (P<0.001). Conclusions: Use of CSII in clinical practice in Sweden is associated with an approximately 0.2% (2mmol/mol) reduction in HbA1c after 5 years.
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19.
  • Chemtob, Raphaelle A., et al. (author)
  • Effects of Sex on Early Outcome following Repair of Acute Type A Aortic Dissection : Results from the Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD)
  • 2019
  • In: AORTA. - : Georg Thieme Verlag KG. - 2325-4637. ; 7:1, s. 7-14
  • Journal article (peer-reviewed)abstract
    • Background Female sex is known to have increased perioperative mortality in cardiac surgery. Studies reporting effects of sex on outcome following surgical repair for acute Type A aortic dissection (ATAAD) have been limited by small cohorts of heterogeneous patient populations and have shown diverging results. This study aimed to compare perioperative characteristics, operative management, and postoperative outcome between sexes in a large and well-defined cohort of patients operated for ATAAD. Methods The Nordic Consortium for Acute Type A Aortic Dissection study included patients with surgical repair of ATAAD at eight Nordic centers between January 2005 and December 2014. Independent predictors of 30-day mortality were identified using multivariable logistic regression. Results Females represented 373 (32%) out of 1,154 patients and were significantly older (65 ± 11 vs. 60 ± 12 years, p < 0.001), had lower body mass index (25.8 ± 5.4 vs. 27.2 ± 4.3 kg/m 2, p < 0.001), and had more often a history of hypertension (59% vs. 48%, p = 0.001) and chronic obstructive pulmonary disease (8% vs. 4%, p = 0.033) compared with males. More females presented with DeBakey class II as compared with males with dissection of the ascending aorta alone (33.4% vs. 23.1%, p = 0.003). Hypothermic cardiac arrest time (28 ± 16 vs. 31 ± 19 minutes, p = 0.026) and operation time (345 ± 133 vs. 374 ± 135 minutes, p < 0.001) were shorter among females. There was no difference between the sexes in unadjusted intraoperative death (9.1% vs. 6.7%, p = 0.17) or 30-day mortality (17.7% vs. 17.4%, p = 0.99). In a multivariable analysis including perioperative factors influencing mortality, no difference was found between females and males in 30-day mortality (odds ratio: 0.92, 95% confidence interval: 0.62-1.38, p = 0.69). Conclusions This study found no association between sex and early mortality following surgery for ATAAD, despite females being older and having more comorbidities, yet also presenting with a less widespread dissection than males.
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20.
  • Chemtob, Raphaelle A., et al. (author)
  • Stroke in acute type A aortic dissection : the Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD)
  • 2020
  • In: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. - : Oxford University Press (OUP). - 1010-7940 .- 1873-734X. ; 58:5, s. 1027-1034
  • Journal article (peer-reviewed)abstract
    • OBJECTIVES: Stroke is a serious complication in patients with acute type A aortic dissection (ATAAD). Previous studies investigating stroke in ATAAD patients have been limited by small cohorts and have shown diverging results. We sought to identify risk factors for stroke and to evaluate the effect of stroke on outcomes in surgical ATAAD patients. METHODS: The Nordic Consortium for Acute Type A Aortic Dissection database included patients operated for ATAAD at 8 Scandinavian Hospitals between 2005 and 2014. RESULTS: Stroke occurred in 177 (15.7%) out of 1128 patients. Patients with stroke presented more frequently with cerebral malperfusion (20.6% vs 6.3%, P < 0.001), syncope (30.6% vs 17.6%, P < 0.001), cardiogenic shock (33.1% vs 20.7%, P < 0.001) and pericardial tamponade (25.9% vs 14.7%, P < 0.001) and more often underwent total aortic arch replacement (10.7% vs 4.7%, P = 0.016), compared to patients without stroke. In the 86 patients presenting with cerebral malperfusion, 38.4% developed stroke. Thirty-day and 5-year mortality in patients with and without stroke were 27.1% vs 13.6% and 42.9% vs 25.6%, respectively. Stroke was an independent predictor of early- [odds ratio 2.02, 95% confidence interval (CI) 1.34-3.05; P < 0.001] and midterm mortality (hazard ratio 1.68, 95% CI 1.27-2.23; P < 0.001). CONCLUSIONS: Stroke in ATAAD patients is associated with increased early- and midterm mortality. Preoperative cerebral malperfusion and impaired haemodynamics, as well as total aortic arch replacement, were more frequent among patients who developed stroke. Importantly, a large proportion of patients presenting with cerebral malperfusion did not develop a permanent stroke, indicating that signs of cerebral malperfusion should not be considered a contraindication for surgery.
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21.
  • Chemtob, Raphaelle A, et al. (author)
  • Stroke in acute type A aortic dissection: the Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD).
  • 2020
  • In: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. - 1873-734X. ; 58:5, s. 1027-1034
  • Journal article (peer-reviewed)abstract
    • Stroke is a serious complication in patients with acute type A aortic dissection (ATAAD). Previous studies investigating stroke in ATAAD patients have been limited by small cohorts and have shown diverging results. We sought to identify risk factors for stroke and to evaluate the effect of stroke on outcomes in surgical ATAAD patients.The Nordic Consortium for Acute Type A Aortic Dissection database included patients operated for ATAAD at 8 Scandinavian Hospitals between 2005 and 2014.Stroke occurred in 177 (15.7%) out of 1128 patients. Patients with stroke presented more frequently with cerebral malperfusion (20.6% vs 6.3%, P<0.001), syncope (30.6% vs 17.6%, P<0.001), cardiogenic shock (33.1% vs 20.7%, P<0.001) and pericardial tamponade (25.9% vs 14.7%, P<0.001) and more often underwent total aortic arch replacement (10.7% vs 4.7%, P=0.016), compared to patients without stroke. In the 86 patients presenting with cerebral malperfusion, 38.4% developed stroke. Thirty-day and 5-year mortality in patients with and without stroke were 27.1% vs 13.6% and 42.9% vs 25.6%, respectively. Stroke was an independent predictor of early- [odds ratio 2.02, 95% confidence interval (CI) 1.34-3.05; P<0.001] and midterm mortality (hazard ratio 1.68, 95% CI 1.27-2.23; P<0.001).Stroke in ATAAD patients is associated with increased early- and midterm mortality. Preoperative cerebral malperfusion and impaired haemodynamics, as well as total aortic arch replacement, were more frequent among patients who developed stroke. Importantly, a large proportion of patients presenting with cerebral malperfusion did not develop a permanent stroke, indicating that signs of cerebral malperfusion should not be considered a contraindication for surgery.
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22.
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23.
  • Ergatoudes, Constantinos, et al. (author)
  • Comparison of incidence rates and risk factors of heart failure between two male cohorts born 30 years apart
  • 2020
  • In: Heart. - : BMJ. - 1355-6037 .- 1468-201X.
  • Journal article (peer-reviewed)abstract
    • Objective: To compare two cohorts of middle-aged men from the general population born 30 years apart for incidence and predictors of heart failure (HF). Methods: Two population samples of men, born in 1913 (n=855) and in 1943 (n=797), were examined at 50 years of age and followed up for 21 years (1963-1994 and 1993-2014). Cox regression analysis was used to examine the impact of different factors on the risk of developing HF. Results: Eighty men born in 1913 (9.4%) and 42 men born in 1943 (5.3%) developed HF during follow-up; adjusted HRs comparing the two cohorts (born 1943 vs 1913) were: 0.46 (95% CI 0.28 to 0.74, p=0.002). In both cohorts, higher body mass index, higher diastolic blood pressure, treatment for hypertension, onset of either atrial fibrillation (AF), ischaemic heart disease and diabetes mellitus were associated with higher risk of HF. Higher heart rate was associated with an increased risk only in men born in 1913, whereas higher systolic blood pressure (SBP), smoking, higher glucose, higher cholesterol and physical inactivity were associated with an increased risk in men born in 1943. AF contributed higher risk of incident HF, whereas SBP and physical inactivity contributed lower risk in men born in 1943 compared with men born in 1913. Conclusions: Men born in 1943 had half the risk of HF after their 50s than those born 30 years earlier. AF, obesity, ischaemic heart disease, diabetes and hypertension remain important precursors of HF. © 2020 Author(s).
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24.
  • Ergatoudes, Constantinos, et al. (author)
  • Non-cardiac comorbidities and mortality in patients with heart failure with reduced vs. preserved ejection fraction: a study using the Swedish Heart Failure Registry
  • 2019
  • In: Clinical Research in Cardiology. - : Springer Science and Business Media LLC. - 1861-0684 .- 1861-0692. ; 108, s. 1025-33
  • Journal article (peer-reviewed)abstract
    • Background: Heart failure (HF) and non-cardiac comorbidities often coexist and are known to have an adverse effect on outcome. However, the prevalence and prognostic impact of non-cardiac comorbidities in patients with HF with reduced ejection fraction (HFrEF) vs. those with preserved (HFpEF) remain inadequately studied. Methods and results: We used data from the Swedish Heart Failure Registry from 2000 to 2012. HFrEF was defined as EF < 50% and HFpEF as EF ≥ 50%. Of 31 344 patients available for analysis, 79.3% (n = 24 856) had HFrEF and 20.7% (n = 6 488) HFpEF. The outcome was all-cause mortality. We examined the association between ten non-cardiac comorbidities and mortality and its interaction with EF using adjusted hazard ratio (HR). Stroke, anemia, gout and cancer had a similar impact on mortality in both phenotypes, whereas diabetes (HR 1.57, 95% confidence interval [CI] [1.50–1.65] vs. HR 1.39 95% CI [1.27–1.51], p = 0.0002), renal failure (HR 1.65, 95% CI [1.57–1.73] vs. HR 1.44, 95% CI [1.32–1.57], p = 0.003) and liver disease (HR 2.13, 95% CI [1.83–2.47] vs. HR 1.42, 95% CI [1.09–1.85] p = 0.02) had a higher impact in the HFrEF patients. Moreover, pulmonary disease (HR 1.46, 95% CI [1.40–1.53] vs. HR 1.66 95% CI [1.54–1.80], p = 0.007) was more prominent in the HFpEF patients. Sleep apnea was not associated with worse prognosis in either group. No significant variation was found in the impact over the 12-year study period. Conclusions: Non-cardiac comorbidities contribute significantly but differently to mortality, both in HFrEF and HFpEF. No significant variation was found in the impact over the 12-year study period. These results emphasize the importance of including the management of comorbidities as a part of a standardized heart failure care in both HF phenotypes. © 2019, The Author(s).
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25.
  • Fu, Michael, 1963, et al. (author)
  • Although Coronary Mortality Has Decreased, Rates of Cardiovascular Disease Remain High: 21 Years of Follow-Up Comparing Cohorts of Men Born in 1913 With Men Born in 1943
  • 2018
  • In: Journal of the American Heart Association (JAHA). - : Ovid Technologies (Wolters Kluwer Health). - 2047-9980. ; 7:9
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Despite a decline in mortality rates from cardiovascular disease (CVD) in the past few decades, the burden of CVD in a contemporary population remains inadequately addressed. Therefore, this study was aimed to investigate secular trends in mortality from coronary artery disease and all-cause mortality over 2 decades, by comparing 2 cohorts of men born 30 years apart and evaluate the prediction of the risk of CVD and all-cause death in a contemporary random sample of Swedish men. METHODS AND RESULTS: Two cohorts of randomly selected men born in 1913 (855 men) and 1943 (798 men) were first examined at age 50 in 1963 and 1993, respectively, and followed longitudinally over 21 years. All-cause mortality and coronary artery disease death were lower in 50- to 71-year-old men born in 1943 compared with those born in 1913, with unadjusted hazard ratios of 0.57 (0.45-0.71) and 0.34 (0.22-0.53), respectively. After adjustment for risk factors (smoking, serum cholesterol, hypertension, systolic blood pressure, diabetes mellitus, body mass index, and physical activity), the differences between the cohorts remained significant for coronary artery disease, hazard ratios 0.57 (0.34-0.94), P=0.029, but not for all-cause mortality hazard ratios 0.82 (0.62-1.07), P=0.14. However, the rate of CVD events during follow-up was still high (30.7%) for the men born in 1943. No statistically significant interaction by birth cohort in contribution of risk factors to death was found between 2 cohorts except physical inactivity. CONCLUSIONS: Despite a marked reduction in the rate of coronary artery disease death over the past 30 years, the burden of CVD events and all-cause mortality remains high. Therefore, intensified efforts to modify contributing risk factors are still required.
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26.
  • Hansson, Emma C., 1985, et al. (author)
  • Preoperative dual antiplatelet therapy increases bleeding and transfusions but not mortality in acute aortic dissection type A repair.
  • 2019
  • In: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. - : Oxford University Press (OUP). - 1873-734X .- 1010-7940. ; 56:1, s. 182-188
  • Journal article (peer-reviewed)abstract
    • Acute aortic dissection type A is a life-threatening condition, warranting immediate surgery. Presentation with sudden chest pain confers a risk of misdiagnosis as acute coronary syndrome resulting in subsequent potent antiplatelet treatment. We investigated the impact of dual antiplatelet therapy (DAPT) on bleeding and mortality using the Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD) database.The NORCAAD database is a retrospective multicentre database where 119 of 1141 patients (10.4%) had DAPT with ASA+clopidogrel (n=108) or ASA+ticagrelor (n=11) before surgery. The incidence of major bleeding and 30-day mortality was compared between DAPT and non-DAPT patients with logistic regression models before and after propensity score matching.Before matching, 51.3% of DAPT patients had major bleeding when compared to 37.7% of non-DAPT patients (P=0.0049). DAPT patients received more transfusions of red blood cells [median 8U (Q1-Q3 4-15) vs 5.5U (2-11), P<0.0001] and platelets [4U (2-8) vs 2U (1-4), P=0.0001]. Crude 30-day mortality was 19.3% vs 17.0% (P=0.60). After matching, major bleeding remained significantly more common in DAPT patients, 51.3% vs 39.3% [odds ratio (OR) 1.63, 95% confidence interval (CI) 1.05-2.51; P=0.028], but mortality did not significantly differ (OR 0.88, 95% CI 0.51-1.50; P=0.63). Major bleeding was associated with increased 30-day mortality (adjusted OR 2.44, 95% CI 1.72-3.46; P<0.0001).DAPT prior to acute aortic dissection repair was associated with increased bleeding and transfusions but not with mortality. Major bleeding per se was associated with a significantly increased mortality. Correct diagnosis is important to avoid DAPT and thereby reduce bleeding risk, but ongoing DAPT should not delay surgery.
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27.
  • Klevebro, S., et al. (author)
  • Elevated levels of IL-6 and IGFBP-1 predict low serum IGF-1 levels during continuous infusion of rhIGF-1/rhIGFBP-3 in extremely preterm infants
  • 2020
  • In: Growth Hormone and IGF Research. - : Elsevier BV. - 1096-6374. ; 50, s. 1-8
  • Journal article (peer-reviewed)abstract
    • Objective: Steady state insulin-like growth factor-1 (IGF-1) levels vary significantly during continuous intravenous infusion of recombinant human insulin-like growth factor-1/recombinant human insulin-like growth factor binding protein-3 (rhIGF-1/rhIGFBP-3) in the first weeks of life in extremely preterm infants. We evaluated interleukin-6 (IL-6) and insulin-like growth factor binding protein-1 (IGFBP-1) levels as predictors of low IGF-1 levels. Methods: Nineteen extremely preterm infants were enrolled in a trial, 9 received rhIGF-1/rhIGFBP-3 and 10 received standard neonatal care. Blood samples were analyzed daily for IGF-1, IL-6 and IGFBP-1 during intervention with rhIGF-1/rhIGFBP-3. Results: Thirty seven percent of IGF-1 values during active treatment were <20 μg/L. Among treated infants, higher levels of IL-6, one and two days before sampled IGF-1, were associated with IGF-1 < 20 μg/L, gestational age adjusted OR 1.30 (95% CI 1.03–1.63), p = .026, and 1.57 (95% CI 1.26–1.97), p < .001 respectively. Higher levels of IGFBP-1 one day before sampled IGF-1 was also associated with IGF-1 < 20 μg/L, gestational age adjusted OR 1.74 (95% CI 1.19–2.53), p = .004. Conclusion: In preterm infants receiving continuous infusion of rhIGF-1/rhIGFBP-3, higher levels of IL-6 and IGFBP-1 preceded lower levels of circulating IGF-1. These findings demonstrate a need to further evaluate if inflammation and/or infection suppress serum IGF-1 levels. The trial is registered at ClinicalTrials.gov (NCT01096784). © 2019
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28.
  • Lind, Marcus, 1976, et al. (author)
  • HbA(1c) level as a risk factor for retinopathy and nephropathy in children and adults with type 1 diabetes: Swedish population based cohort study
  • 2019
  • In: Bmj-British Medical Journal. - : BMJ. - 1756-1833. ; 366
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE To evaluate if the lowest target level for glycated haemoglobin (HbA(1c)) of < 6.5% is associated with lower risk for retinopathy and nephropathy than less tight control in children and adults with type 1 diabetes. Swedish National Diabetes Registry, 1 January 1998 to 31 December 2017. 10 398 children and adults with type 1 diabetes followed from diagnosis, or close thereafter, until end of 2017. Relative risk (odds ratios) for retinopathy and nephropathy for different mean levels of HbA(1c). Mean age of participants was 14.7 years (43.4% female), mean duration of diabetes was 1.3 years, and mean HbA(1c) level was 8.0% (63.4 mmol/mol). After adjustment for age, sex, duration of diabetes, blood pressure, blood lipid levels, body mass index, and smoking, the odds ratio for mean HbA(1c) < 6.5% (< 48 mmol/mol) compared with 6.5-6.9% (48-52 mmol/mol) for any retinopathy (simplex or worse) was 0.77 (95% confidence interval 0.56 to 1.05, P=0.10), for preproliferative diabetic retinopathy or worse was 3.29 (0.99 to 10.96, P=0.05), for proliferative diabetic retinopathy was 2.48 (0.71 to 8.62, P=0.15), for microalbuminuria or worse was 0.98 (0.60 to 1.61, P=0.95), and for macroalbuminuria was 2.47 (0.69 to 8.87, P=0.17). Compared with HbA(1c) levels 6.56.9%, HbA(1c) levels 7.0-7.4% (53-57 mmol/mol) were associated with an increased risk of any retinopathy (1.31, 1.05 to 1.64, P=0.02) and microalbuminuria (1.55, 1.03 to 2.32, P=0.03). The risk for proliferative retinopathy (5.98, 2.10 to 17.06, P<0.001) and macroalbuminuria (3.43, 1.14 to 10.26, P=0.03) increased at HbA(1c) levels > 8.6% (> 70 mmol/mol). The risk for severe hypoglycaemia was increased at mean HbA(1c) < 6.5% compared with 6.5-6.9% (relative risk 1.34, 95% confidence interval 1.09 to 1.64, P=0.005). Risk of retinopathy and nephropathy did not differ at HbA(1c) levels < 6.5% but increased for severe hypoglycaemia compared with HbA(1c) levels 6.5-6.9%. The risk for severe complications mainly occurred at HbA(1c) levels > 8.6%, but for milder complications was increased at HbA(1c) levels > 7.0%.
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29.
  • Lind, Marcus, 1976, et al. (author)
  • The Association between HbA1c, Fasting Glucose, 1-Hour Glucose and 2-Hour Glucose during an Oral Glucose Tolerance Test and Cardiovascular Disease in Individuals with Elevated Risk for Diabetes
  • 2014
  • In: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 9:10
  • Journal article (peer-reviewed)abstract
    • Objective: To determine the association between HbA1c, fasting plasma glucose (FPG), 1-hour (1 hPG) and 2-hour (2 hPG) glucose after an oral glucose tolerance test (OGTT) and cardiovascular disease in individuals with elevated risk for diabetes. Design: We studied the relationship between baseline, updated mean and updated (last) value of HbA1c, FPG, 1 hPG and 2 hPG after an oral 75 g glucose tolerance test (OGTT) and acute CVD events in 504 individuals with impaired glucose tolerance (IGT) at baseline enrolled in the Finnish Diabetes Prevention Study. Participants: 504 individuals with IGT were followed with yearly evaluations with OGTT, FPG and HbA1c. Results: Over a median follow-up of 9.0 years 34 (6.7%) participants had a CVD event, which increased to 52 (10.3%) over a median follow-up of 13.0 years when including events that occurred among participants following a diagnosis of diabetes. Updated mean HbA1c, 1 hPG and 2 hPG, HR per 1 unit SD of 1.57 (95% CI 1.16 to 2.11), p = 0.0032, 1.51 (1.03 to 2.23), p = 0.036 and 1.60 (1.10 to 2.34), p = 0.014, respectively, but not FPG (p = 0.11), were related to CVD. In analyses of the last value prior to the CVD event the same three glycaemic measurements were associated with the CVD events, with HRs per 1 unit SD of 1.45 (1.06 to 1.98), p = 0.020, 1.55 (1.04 to 2.29), p = 0.030 and 2.19 (1.51 to 3.18), p < 0.0001, respectively but only 2 hPG remained significant in pairwise comparisons. Including the follow-up period after diabetes onset updated 2 hPG (p = 0.003) but not updated mean HbA1c (p = 0.08) was related to CVD. Conclusions and Relevance: Current 2 hPG level in people with IGT is associated with increased risk of CVD. This supports its use in screening for prediabetes and monitoring glycaemic levels of people with prediabetes.
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30.
  • Matuleviciene, Viktorija, et al. (author)
  • A Clinical Trial of the Accuracy and Treatment Experience of the Dexcom G4 Sensor (Dexcom G4 System) and Enlite Sensor (Guardian REAL-Time System) Tested Simultaneously in Ambulatory Patients with Type 1 Diabetes
  • 2014
  • In: Diabetes Technology & Therapeutics. - : Mary Ann Liebert Inc. - 1520-9156 .- 1557-8593. ; 16:11, s. 759-767
  • Journal article (peer-reviewed)abstract
    • Background: Continuous glucose monitoring (CGM) is a tool widely used in the treatment of patients with type 1 diabetes. The purpose of the current study was to evaluate whether accuracy and patient treatment satisfaction differ between the Enlite (TM) (Medtronic MiniMed, Inc., Northridge, CA) and Dexcom((R)) (San Diego, CA) G4 PLATINUM CGM sensors. Subjects and Methods: Thirty-eight ambulatory patients with type 1 diabetes used the Dexcom G4 and Enlite sensors simultaneously for a minimum of 4 and maximum of 6 days. Patients measured capillary glucose levels with a HemoCue((R)) (angelholm, Sweden) system six to 10 times a day. In addition, two inpatient studies were performed between Days 1-3 and 4-6. Results: The mean absolute relative difference (MARD) in blood glucose for the Dexcom G4 was significantly lower (13.9%) than for the Enlite sensor (17.8%) (P<0.0001). The corresponding MARDs for Days 1-3 were 15.0% versus 19.4% (P=0.0027) and 13.6% versus 15.9% (P=0.026) for Days 4-6. For glucose levels in the hypoglycemic range (<4.0 mmol/L), the MARD for the Dexcom G4 was 20.0% compared with 34.7% for the Enlite (P=0.0041). On a visual analog scale (VAS) (0-100), patients rated the Dexcom G4 more favorably than the Enlite in 12 out of the 13 user experience questions. For example, more patients rated their experience with the Dexcom G4 as positive (VAS, 79.7 vs. 46.6; P<0.0001) and preferred to use it in their daily lives (VAS, 79.1 vs. 42.1; P<0.0001). Conclusions: The Dexcom G4 sensor was associated with greater overall accuracy than the Enlite sensor during initial (Days 1-3) and later (Days 4-6) use and for glucose levels in the hypoglycemic range. Patients reported a significantly more positive experience using the Dexcom G4 than the Enlite.
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31.
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32.
  • Olafsdottir, Arndis, 1978, et al. (author)
  • A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes
  • 2017
  • In: Diabetes Technology & Therapeutics. - : Mary Ann Liebert Inc. - 1520-9156 .- 1557-8593. ; 19:3, s. 164-172
  • Journal article (peer-reviewed)abstract
    • Background: In Sweden, FreeStyle Libre a flash glucose monitoring system came onto the market in 2014 as a complement to self-monitoring of blood glucose. The aim of this study was to evaluate the accuracy and treatment experience of the FreeStyle Libre system. Methods: Fifty-eight adults with type 1 diabetes used FreeStyle Libre for 10-14 days and measured capillary blood glucose levels with the HemoCue blood glucose measurement system at least six times a day simultaneously. Results: For the entire study period, the mean absolute relative difference (MARD) was 13.2% (95% confidence interval [CI] 12.0%-14.4%). MARD was 13.6% (95% CI 12.1%-15.4%) during week 1 and 12.7% (95% CI 11.5%-13.9%) during week 2. The mean absolute difference (MAD) for the whole study period was 19.8mg/dL (1.1mmol/L) (95% CI 17.8-21.8 mg/dL), including 20.5 mg/dL (1.14 mmol/L) during week 1 and 19.0 mg/dL (1.05 mmol/L) during week 2. The overall correlation coefficient was 0.96. For glucose values < 72, 72-180, and > 180mg/dL (< 4, 4-10, and > 10 mmol/L), the MARD was 20.3% (95% CI 17.7%-23.1%), 14.7% (95% CI 13.4%-16%), and 9.6% (95% CI 8.5%-10.8%), respectively, and respective MAD values were 12.3, 17.8, and 23.6 mg/dL (0.69, 0.99, and 1.31mmol/L). Using the 10-item visual analog scale, patients rated their experience with FreeStyle Libre as generally positive, with mean values ranging from 8.22 to 9.8. Conclusions: FreeStyle Libre had a similar overall MARD as continuous blood glucose monitoring systems in earlier studies when studied in similar at-home conditions. The overall patient satisfaction was high.
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33.
  • Olafsdottir, Arndis, 1978, et al. (author)
  • Excess risk of lower extremity amputations in people with type 1 diabetes compared with the general population: Amputations and type 1 diabetes
  • 2019
  • In: BMJ Open Diabetes Research and Care. - : BMJ. - 2052-4897. ; 7:1
  • Journal article (peer-reviewed)abstract
    • Objective This study investigates how the excess risk of lower extremity amputations (amputations) in people with type 1 diabetes mellitus (DM) differs from the general population by diabetes duration, glycemic control, and renal complications. Research design and methods We analyzed data from people with type 1 DM from the Swedish National Diabetes Register without prior amputation from January 1998 to December 2013. Each person (n=36 872) was randomly matched with five controls by sex, age, and county (n=184 360) from the population without diabetes. All were followed until first amputation, death or end of follow-up. Results The overall adjusted HR for all amputation was 40.1 (95% CI 32.8 to 49.1) for type 1 DM versus controls. HR increased with longer diabetes duration. The incidence of amputation/1000 patient-years was 3.18 (95% CI 2.99 to 3.38) for type 1 DM and 0.07 (95% CI 0.05 to 0.08) for controls. The incidence decreased from 1998-2001 (3.09, 95% CI 2.56 to 3.62) to 2011-2013 (2.64, 95% CI 2.31 to 2.98). The HR for major amputations was lower than for minor amputations and decreased over the time period (p=0.0045). Worsening in glycemic control among patients with diabetes led to increased risk for amputation with an HR of 1.80 (95% CI 1.72 to 1.88) per 10 mmol/mol (1%) increase in hemoglobin A1c. Conclusions Although the absolute risk of amputation is relatively low, the overall excess risk was 40 times that of controls. Excess risk was substantially lower for those with good glycemic control and without renal complications, but excess risk still existed and is greatest for minor amputations. © 2019 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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34.
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35.
  • Pivodic, Aldina, 1978, et al. (author)
  • Individual Risk Prediction for Sight-Threatening Retinopathy of Prematurity Using Birth Characteristics
  • 2020
  • In: JAMA Ophthalmology. - : American Medical Association (AMA). - 2168-6165 .- 2168-6173. ; 138:1, s. 21-29
  • Journal article (peer-reviewed)abstract
    • Importance: To prevent blindness, repeated infant eye examinations are performed to detect severe retinopathy of prematurity (ROP), yet only a small fraction of those screened need treatment. Early individual risk stratification would improve screening timing and efficiency and potentially reduce the risk of blindness. Objectives: To create and validate an easy-to-use prediction model using only birth characteristics and to describe a continuous hazard function for ROP treatment. Design, Setting, and Participants: In this retrospective cohort study, Swedish National Patient Registry data from infants screened for ROP (born between January 1, 2007, and August 7, 2018) were analyzed with Poisson regression for time-varying data (postnatal age, gestational age [GA], sex, birth weight, and important interactions) to develop an individualized predictive model for ROP treatment (called DIGIROP-Birth [Digital ROP]). The model was validated internally and externally (in US and European cohorts) and compared with 4 published prediction models. Main Outcomes and Measures: The study outcome was ROP treatment. The measures were estimated momentary and cumulative risks, hazard ratios with 95% CIs, area under the receiver operating characteristic curve (hereinafter referred to as AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results: Among 7609 infants (54.6% boys; mean [SD] GA, 28.1 [2.1] weeks; mean [SD] birth weight, 1119 [353] g), 442 (5.8%) were treated for ROP, including 142 (40.1%) treated of 354 born at less than 24 gestational weeks. Irrespective of GA, the risk for receiving ROP treatment increased during postnatal weeks 8 through 12 and decreased thereafter. Validations of DIGIROP-Birth for 24 to 30 weeks' GA showed high predictive ability for the model overall (AUC, 0.90 [95% CI, 0.89-0.92] for internal validation, 0.94 [95% CI, 0.90-0.98] for temporal validation, 0.87 [95% CI, 0.84-0.89] for US external validation, and 0.90 [95% CI, 0.85-0.95] for European external validation) by calendar periods and by race/ethnicity. The sensitivity, specificity, PPV, and NPV were numerically at least as high as those obtained from CHOP-ROP (Children's Hospital of Philadelphia-ROP), OMA-ROP (Omaha-ROP), WINROP (weight, insulinlike growth factor 1, neonatal, ROP), and CO-ROP (Colorado-ROP), models requiring more complex postnatal data. Conclusions and Relevance: This study validated an individualized prediction model for infants born at 24 to 30 weeks' GA, enabling early risk prediction of ROP treatment based on birth characteristics data. Postnatal age rather than postmenstrual age was a better predictive variable for the temporal risk of ROP treatment. The model is an accessible online application that appears to be generalizable and to have at least as good test statistics as other models requiring longitudinal neonatal data not always readily available to ophthalmologists.
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36.
  • Pivodic, Aldina, 1978, et al. (author)
  • Validation of the Retinopathy of Prematurity Activity Scale (ROP-ActS) using retrospective clinical data
  • 2021
  • In: Acta Ophthalmologica. - : Wiley. - 1755-375X .- 1755-3768. ; 99:2, s. 201-206
  • Journal article (peer-reviewed)abstract
    • Purpose The International Neonatal Consortium recently published a proposed retinopathy of prematurity (ROP) activity scale intended for use in clinical trials after validation. The aim of this study was to validate the ROP activity scale (ROP-ActS) in a ROP screened cohort with protocol based collected data by evaluating the ability of the ROP-Act scores to predict ROP treatment. In addition, we aimed to evaluate the scale's sensitivity characteristic of disease severity by studying association with gestational age (GA) in comparison with conventionally used ROP stage and zone. Methods A cohort of 535 preterm infants with 3324 ROP examinations with an end-point of ROP treatment or end of screening in Gothenburg, Sweden, was included. Median GA was 28.1 weeks, 47.5% were girls, and 74 (13.8%) infants were treated for ROP. The validation was performed by estimating probabilities for ROP treatment, and by applying logistic and linear regression. Results The original ROP-ActS was overall well-ordered with respect to ability to predict ROP treatment but could be improved by re-ordering score 3 (zone II stage 1) and 5 (zone III stage 3) based on our clinical cohort data. The modified ROP-ActS was superior to ROP stage and zone in the prediction analysis of ROP treatment. Modified ROP-ActS was more strongly related to GA than currently used ROP stage, but not zone. Conclusion In the studied cohort, the modified ROP-ActS could better predict ROP treatment compared to ROP stage and zone. Retinopathy of Prematurity Activity Scale (ROP-ActS) had a superior sensitivity characteristic studied through association to GA than conventionally used ROP stage.
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37.
  • Silverdal, Jonas, et al. (author)
  • Prognostic impact over time of ischaemic heart disease vs. non-ischaemic heart disease in heart failure
  • 2020
  • In: Esc Heart Failure. - : Wiley. - 2055-5822. ; 7:1, s. 265-274
  • Journal article (peer-reviewed)abstract
    • Aims The aim of this study is to investigate the prognostic impact of ischaemic heart disease (IHD) in heart failure (HF) and its association to age, sex, left ventricular ejection fraction (EF), and HF duration, and furthermore, to evaluate if the impact of IHD has changed over time, in light of improved therapy. Methods and results We studied 30 946 patients with non-valvular HF, by accessing the Swedish Heart Failure Registry, from years 2000 to 2012. The mortality in 17 778 patients with clinical IHD was compared with 13 168 patients without IHD (non-IHD). There was a significantly worse outcome in IHD, with the crude mortality of 41.1% and the event rate per 100 person-years [95% confidence interval (CI)] of 14.8 (14.4-15.1), compared with 28.2% and 9.7 (9.4-10.0) in non-IHD. After multivariable adjustment, the hazard ratio (HR) (95% CI) for mortality, IHD vs. non-IHD, was 1.16 (1.11-1.22; P < 0.0001). Subgroup analyses showed significantly increased mortality in IHD, in all age subgroups, in all subgroups with EF < 50%, in both men and women, and regardless of heart failure duration more or less than 6 months. Analyses for the combination of age and EF showed the highest HR for time to death in the youngest with the lowest EF, HR (95% CI) 2.05 (1.59-2.64) for patients <60 years of age with EF < 30%. Although a numerical reduction of the HR for mortality was seen over time, the risk for mortality in IHD, compared with the non-IHD group, was greater throughout the study period. Conclusions In non-valvular heart failure, IHD was associated with significantly increased mortality, compared with non-IHD, in groups of EF below 50%, in all age groups, and regardless of sex or HF duration. The risk increase associated with EF reduction diminished with increasing age. The mortality in IHD, compared with non-IHD, remained significantly higher throughout the 13 year study period.
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38.
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