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| 2. |
- Batra, Gorav, et al.
(författare)
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Antithrombotic therapy after myocardial infarction in patients with atrial fibrillation undergoing percutaneous coronary intervention
- 2018
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Ingår i: European Heart Journal - Cardiovascular Pharmacotherapy. - : Oxford University Press (OUP). - 2055-6837 .- 2055-6845. ; 4:1, s. 36-45
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Tidskriftsartikel (refereegranskat)abstract
- Aims Optimal antithrombotic therapy after percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI) and atrial fibrillation is uncertain. In this study, we compared antithrombotic regimes with regard to a composite cardiovascular outcome of all-cause mortality, MI or ischaemic stroke, and major bleeds. Methods and results Patients between October 2005 and December 2012 were identified in Swedish registries, n = 7116. Landmark 0-90 and 91-365 days of outcome were evaluated with Cox-regressions, with dual antiplatelet therapy as reference. At discharge, 16.2% received triple therapy (aspirin, clopidogrel, and warfarin), 1.9% aspirin plus warfarin, 7.3% clopidogrel plus warfarin, and 60.8% dual antiplatelets. For cardiovascular outcome, adjusted hazard ratio with 95% confidence interval (HR) for triple therapy was 0.86 (0.70-1.07) for 0-90 days and 0.78 (0.58-1.05) for 91-365 days. A HR of 2.16 (1.48-3.13) and 1.61 (0.98-2.66) during 0-90 and 91-365 days, respectively, was observed for major bleeds. For aspirin plus warfarin, HR 0.82 (0.54-1.26) and 0.62 (0.48-0.79) was observed for cardiovascular outcome and 1.30 (0.60-2.85) and 1.01 (0.63-1.62) for major bleeds during 0-90 and 91-365 days, respectively. For clopidogrel plus warfarin, HR of 0.90 (0.68-1.19) and 0.68 (0.49-0.95) was observed for cardiovascular outcome and 1.28 (0.71-2.32) and 1.08 (0.57-2.04) for major bleeds during 0-90 and 91-365 days, respectively. Conclusion Compared to dual antiplatelets, aspirin or clopidogrel plus warfarin therapy was associated with similar 0-90 days and lower 91-365 days of risk of the cardiovascular outcome, without higher risk of major bleeds. Triple therapy was associated with non-significant lower risk of cardiovascular outcome and higher risk of major bleeds.
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| 3. |
- Fu, Michael, 1963, et al.
(författare)
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Implementation of sacubitril/valsartan in Sweden: clinical characteristics, titration patterns, and determinants
- 2020
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Ingår i: Esc Heart Failure. - : Wiley. - 2055-5822.
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Tidskriftsartikel (refereegranskat)abstract
- Aims The aim of this study is to study the introduction of sacubitril/valsartan (sac/val) in Sweden with regards to regional differences, clinical characteristics, titration patterns, and determinants of use and discontinuation. Methods and results A national cohort of heart failure was defined from the Swedish Prescribed Drug Register and National Patient Register. A subcohort with additional data from the Swedish Heart Failure Registry (SwedeHF) was also studied. Cohorts were subdivided as per sac/val prescription and registration in SwedeHF. Median sac/val prescription rate was 20 per 100 000 inhabitants. Between April 2016 and December 2017, we identified 2037 patients with >= 1 sac/val prescription, of which 1144 (56%) were registered in SwedeHF. Overall, patients prescribed with sac/val were younger, more frequently male, and had less prior cardiovascular disease than non-sac/val patients. In SwedeHF subcohort, patients prescribed with sac/val had lower ejection fraction. Overall, younger age [hazard ratio 2.81 (95% confidence interval 2.45-3.22)], registration in SwedeHF [1.97 (1.83-2.12)], male gender [1.50 (1.37-1.64)], ischaemic heart disease [1.50 (1.39-1.62)], lower left ventricular ejection fraction [3.06 (2.18-4.31)], and New York Heart Association IV [1.50 (1.22-1.84)] were predictors for sac/val use. As initiation dose in the sac/val cohort, 38% received 24/26 mg, 54% 49/51 mg, and 9% 97/103 mg. Up-titration to the target dose was achieved in 57% of the overall cohort over a median follow-up of 6 months. The estimated treatment persistence for any dose at 360 days was 82%. Conclusions Implementation of sac/val in Sweden was slow and varied five-fold across different regions; younger age, male, SwedeHF registration, and ischaemic heart disease were among the independent predictors of receiving sac/val. Overall, treatment persistence and tolerability was high.
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| 4. |
- Gedeborg, Rolf, et al.
(författare)
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Federated analyses of multiple data sources in drug safety studies
- 2023
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Ingår i: Pharmacoepidemiology and Drug Safety. - : John Wiley & Sons. - 1053-8569 .- 1099-1557. ; 32:3, s. 279-286
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Forskningsöversikt (refereegranskat)abstract
- PurposeStudies of rare side effects of new drugs with limited exposure may require pooling of multiple data sources. Federated Analyses (FA) allow real-time, interactive, centralized statistical processing of individual-level data from different data sets without transfer of sensitive personal data.MethodsWe review IT-architecture, legal considerations, and statistical methods in FA, based on a Swedish Medical Products Agency methodological development project.ResultsIn a review of all post-authorisation safety studies assessed by the EMA during 2019, 74% (20/27 studies) reported issues with lack of precision in spite of mean study periods of 9.3 years. FA could potentially improve precision in such studies. Depending on the statistical model, the federated approach can generate identical results to a standard analysis. FA may be particularly attractive for repeated collaborative projects where data is regularly updated. There are also important limitations. Detailed agreements between involved parties are strongly recommended to anticipate potential issues and conflicts, document a shared understanding of the project, and fully comply with legal obligations regarding ethics and data protection. FA do not remove the data harmonisation step, which remains essential and often cumbersome. Reliable support for technical integration with the local server architecture and security solutions is required. Common statistical methods are available, but adaptations may be required.ConclusionsFederated Analyses require competent and active involvement of all collaborating parties but have the potential to facilitate collaboration across institutional and national borders and improve the precision of postmarketing drug safety studies.
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| 5. |
- Jaafar, G., et al.
(författare)
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Outcomes of antibiotic prophylaxis in acute cholecystectomy in a population-based gallstone surgery registry
- 2014
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Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 101:2, s. 69-73
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThe aim of this study was to assess the effect of antibiotic prophylaxis (AP) on postoperative infections in acute cholecystectomy.MethodsThe study was based on acute cholecystectomies registered in the nationwide Swedish Register for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks) between 2006 and 2010. The association between AP and the risk of postoperative infectious complications was tested in a multivariable regression analysis, with stepwise addition of age, sex, duration of operation, indication for surgery, surgical approach (laparoscopic versus open) and American Society of Anesthesiologists (ASA) fitness grade as co-variables. Postoperative infections requiring antibiotic treatment and postoperative abscesses were defined as outcome measures.ResultsAP was given to 9549 (686 per cent) of 13 911 patients. Postoperative infections requiring antibiotic treatment occurred following 1070 procedures (77 per cent), including 805 patients (84 per cent) who received AP (P < 0001 versus patients without AP). Postoperative abscesses developed after 273 procedures (20 per cent), including 208 patients (22 per cent) who received AP (P = 0007). In univariable analysis, the odds ratio for development of infectious complications necessitating treatment with antibiotics was 142 (95 per cent confidence interval 123 to 164) for those who received APversus those who did not, and for postoperative abscesses it was 147 (111 to 195). In multivariable analysis, adjusting for confounders, the odds ratios were 093 (079 to 110) and 088 (064 to 121) respectively.ConclusionThe present study suggests that AP provides no benefit in acute cholecystectomy. No benefit from antibiotics
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| 6. |
- Jernberg, Tomas, et al.
(författare)
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Association Between Adoption of Evidence-Based Treatment and Survival for Patients With ST-Elevation Myocardial Infarction
- 2011
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Ingår i: Journal of the American Medical Association (JAMA). - : American Medical Association (AMA). - 0098-7484 .- 1538-3598. ; 305:16, s. 1677-1684
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Tidskriftsartikel (refereegranskat)abstract
- Context Only limited information is available on the speed of implementation of new evidence-based and guideline-recommended treatments and its association with survival in real life health care of patients with ST-elevation myocardial infarction (STEMI). Objective To describe the adoption of new treatments and the related chances of short-and long-term survival in consecutive patients with STEMI in a single country over a 12-year period. Design, Setting, and Participants The Register of Information and Knowledge about Swedish Heart Intensive Care Admission (RIKS-HIA) records baseline characteristics, treatments, and outcome of consecutive patients with acute coronary syndrome admitted to almost all hospitals in Sweden. This study includes 61 238 patients with a first-time diagnosis of STEMI between 1996 and 2007. Main Outcome Measures Estimated and crude proportions of patients treated with different medications and invasive procedures and mortality over time. Results Of evidence based-treatments, reperfusion increased from 66% (95%, confidence interval [CI], 52%-79%) to 79% (95% CI, 69%-89%; P<.001), primary percutaneous coronary intervention from 12% (95% CI, 11%-14%) to 61% (95% CI, 45%-77%; P<.001), and revascularization from 10% (96% CI, 6%-14%) to 84% (95% CI, 73%-95%; P<.001). The use of aspirin, clopidogrel, beta-blockers, statins, and angiotensin-converting enzyme (ACE) inhibitors all increased: clopidogrel from 0% to 82% (95% CI, 69%-95%; P<.001), statins from 23% (95% CI, 12%-33%) to 83% (95% CI, 75%-91%; P<.001), and ACE inhibitor or angiotensin II receptor blockers from 39% (95% CI, 26%-52%) to 69% (95% CI, 58%-70%; P<.001). The estimated in-hospital, 30-day and 1-year mortality decreased from 12.5% (95% CI, 4.3%-20.6%) to 7.2% (95% CI, 1.7%-12.6%; P<.001); from 15.0% (95% CI, 6.2%-23.7%) to 8.6% (95% CI, 2.7%-14.5%; P<.001); and from 21.0% (95% CI, 11.0%-30.9%) to 13.3% (95% CI, 6.0%-20.4%; P<.001), respectively. After adjustment, there was still a consistent trend with lower standardized mortality over the years. The 12-year survival analyses showed that the decrease of mortality was sustained over time. Conclusion In a Swedish registry of patients with STEMI, between 1996 and 2007, there was an increase in the prevalence of evidence-based treatments. During this same time, there was a decrease in 30-day and 1-year mortality that was sustained during long-term follow-up.
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| 7. |
- Jernberg, Tomas, et al.
(författare)
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Impact of ischaemic heart disease severity and age on risk of cardiovascular outcome in diabetes patients in Sweden : A nationwide observational study
- 2019
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 9:4
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To compare short-term cardiovascular (CV) outcome in type 2 diabetes (T2D) patients without ischaemic heart disease (IHD), with IHD but no prior myocardial infarction (MI), and those with prior MI; and assess the impact on risk of age when initiating first-time glucose-lowering drug (GLD). Design Cohort study linking morbidity, mortality and medication data from Swedish national registries. Participants First-time users of GLD during 2007-2016. Outcomes Predicted cumulative incidence for the CV outcome (MI, stroke and CV mortality) was estimated. A Cox model was developed where age at GLD start and CV risk was modelled. Results 260 070 first-time GLD users were included, 221 226 (85%) had no IHD, 16 294 (6%) had stable IHD-prior MI and 22 550 (9%) had IHD+MI. T2D patients without IHD had a lower risk of CV outcome compared with the IHD populations (±prior MI), (3-year incidence 4.78% vs 5.85% and 8.04%). The difference in CV outcome was primarily driven by a relative greater MI risk among the IHD patients. For T2D patients without IHD, an almost linear association between age at start of GLD and relative risk was observed, whereas in IHD patients, the younger (<60 years) patients had a relative greater risk compared with older patients. Conclusions T2D patients without IHD had a lower risk of the CV outcome compared with the T2D populations with IHD, primarily driven by a greater risk of MI. For T2D patients without IHD, an almost linear association between age at start of GLD and relative risk was observed, whereas in IHD patients, the younger patients had a relative greater risk compared with older patients. Our findings suggest that intense risk prevention should be the key strategy in the management of T2D patients, especially for younger patients.
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| 8. |
- Lindholm, Daniel, et al.
(författare)
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Combined association of key risk factors on ischaemic outcomes and bleeding in patients with myocardial infarction
- 2019
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Ingår i: Heart. - : BMJ PUBLISHING GROUP. - 1355-6037 .- 1468-201X. ; 105:15, s. 1175-1181
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Tidskriftsartikel (refereegranskat)abstract
- Objective: In patients with myocardial infarction (MI), risk factors for bleeding and ischaemic events tend to overlap, but the combined effects of these factors have scarcely been studied in contemporary real-world settings. We aimed to assess the combined associations of established risk factors using nationwide registries.Methods: Using the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry, patients with invasively managed MI in 2006-2014 were included. Six factors were assessed in relation to cardiovascular death (CVD)/MI/stroke, and major bleeding: age >= 65, chronic kidney disease, diabetes, multivessel disease, prior bleeding and prior MI.Results: We studied 100 879 patients, of whom 20 831 (20.6%) experienced CVD/MI/stroke and 5939 (5.9%) major bleeding, during 3.6 years median follow-up. In adjusted Cox models, all factors were associated with CVD/MI/stroke, and all but prior MI were associated with major bleeding. The majority (53.5%) had >= 2 risk factors. With each added risk factor, there was a marked but gradual increase in incidence of the CVD/MI/stroke. This was seen also for major bleeding, but to a lesser extent, largely driven by prior bleeding as the strongest risk factor.Conclusions: The majority of patients with MI had two or more established risk factors. Increasing number of risk factors was associated with higher rate of ischaemic events. When excluding patients with prior major bleeding, bleeding incidence rate increased only minimally with increasing number of risk factors. The high ischaemic risk in those with multiple risk factors highlights an unmet need for additional preventive measures.
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| 9. |
- Lund, Lars H., et al.
(författare)
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Association of Spironolactone Use With All-Cause Mortality in Heart Failure A Propensity Scored Cohort Study
- 2013
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Ingår i: Circulation Heart Failure. - : Lippincott Williams & Wilkins. - 1941-3289 .- 1941-3297. ; 6:2, s. 174-183
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Tidskriftsartikel (refereegranskat)abstract
- Background-In 3 randomized controlled trials in heart failure (HF), mineralocorticoid receptor antagonists reduced mortality. The net benefit from randomized controlled trials may not be generalizable, and eplerenone was, but spironolactone was not, studied in mild HF. We tested the hypothesis that spironolactone is associated with reduced mortality also in a broad unselected contemporary population with HF and reduced ejection fraction, in particular New York Heart Association (NYHA) I-II. Methods and Results-We prospectively studied 18 852 patients (age 71+/-12 years; 28% women) with NYHA I-IV and ejection fraction <40% who were registered in the Swedish Heart Failure Registry between 2000 and 2012 and who were (n=6551) or were not (n=12 301) treated with spironolactone. We derived propensity scores for spironolactone treatment based on 41 covariates. We assessed survival by Cox regression with adjustment for propensity scores and with matching based on propensity score. We performed sensitivity and residual confounding analyses and analyzed the NYHA I-II and III-IV subgroups separately. One-year survival was 83% versus 84% in treated versus untreated patients (log rank P<0.001). After adjustment for propensity scores, the hazard ratio for spironolactone was 1.05 (95% confidence interval, 1.00-1.11; P=0.054). Spironolactone interacted with NYHA (P<0.001). In the NYHA I-II subgroup, after adjustment for propensity scores, the hazard ratio for spironolactone was 1.11 (95% confidence interval, 1.02-1.21; P=0.019). Conclusions-In an unselected contemporary population of HF with reduced ejection fraction, spironolactone was not associated with reduced mortality. The net benefits of spironolactone may be lower outside the clinical trial setting and in milder HF.
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| 10. |
- Lund, Lars H., et al.
(författare)
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Effect of expanding evidence and evolving clinical guidelines on the prevalence of indication for cardiac resynchronization therapy in patients with heart failure
- 2018
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Ingår i: European Journal of Heart Failure. - : WILEY. - 1388-9842 .- 1879-0844. ; 20:4, s. 769-777
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To assess the prevalence of indication for cardiac resynchronization therapy (CRT) in patients with heart failure (HF) and reduced ejection fraction (EF) when recommendations from evolving European Society of Cardiology (ESC) guidelines are considered.Methods and results: Unique patients (n=17 193) with EF <= 39% and key data available for evaluation of CRT indication from the Swedish HF Registry were included. Indication for CRT was defined as either CRT implanted or CRT device absent but fulfilling criteria for class I-IIa recommendations in ESC guidelines published between 2005/2007 and 2016. Prevalence was calculated as the ratio of patients with CRT indication to the study population. The prevalence of CRT indication increased from 24.5% when the 2005/2007 ESC guidelines were considered to a peak of 30.0% when the 2013 ESC guidelines were considered (P<0.001, 22.4% relative increase). Compared to the 2013 ESC guidelines, the prevalence declined significantly when the 2016 ESC guidelines were used as determinant for CRT indication (26.8%, 10.7% relative reduction, P<0.001). Actual CRT utilization was 6.8%.Conclusion: Among patients with HF and reduced EF, the prevalence of CRT indication increased significantly comparing recommendations from ESC guidelines published between 2005/2007 and 2013, but then declined when the 2016 ESC guidelines were considered. The 2005-2013 increase may reflect the expansion of documented CRT efficacy to New York Heart Association class II, whereas the subsequent drop likely results from the more stringent criteria for QRS duration in the 2016 ESC guidelines. Actual CRT utilization is lower than indicated, regardless of which guidelines are considered.
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