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Sökning: WFRF:(Mitha A)

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  • Ruilope, LM, et al. (författare)
  • Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
  • 2019
  • Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
  • Tidskriftsartikel (refereegranskat)abstract
    • <b><i>Background:</i></b> Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. <b><i>Patients and</i></b> <b><i>Methods:</i></b> The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m<sup>2</sup> and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.
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  • Mitha, A, et al. (författare)
  • Neonatal Morbidities and Feeding Tolerance Outcomes in Very Preterm Infants, before and after Introduction of Probiotic Supplementation
  • 2022
  • Ingår i: Nutrients. - : MDPI AG. - 2072-6643. ; 14:17
  • Tidskriftsartikel (refereegranskat)abstract
    • While probiotics are reported to reduce the risks of neonatal morbidities, less is known about probiotics and feeding tolerance. With this retrospective cohort study, we investigate whether introduction of probiotic supplementation as the standard of care was associated with fewer neonatal morbidities and improved feeding tolerance in very preterm infants. Using the Swedish Neonatal Quality Register, 345 live-born very preterm infants (28–31 weeks’ gestation), from January 2019–August 2021, in NICUs in Stockholm, Sweden, either received probiotic supplementation (Bifidobacterium infantis, Bifidobacterium lactis, Streptococcusthermophilus) (139) or no supplementation (206); they were compared regarding a primary composite outcome of death, sepsis, and/or necrotising enterocolitis and secondary outcomes: time to full enteral feeding and antibiotics use. Probiotics seemed associated with a reduced risk of the composite outcome (4.3% versus 9.2%, p = 0.08). In the subgroup of 320 infants without the primary outcome, probiotics were associated with shorter time to full enteral feeding (6.6 days versus 7.2 days) and less use of antibiotics (5.2 days versus 6.1 days). Our findings suggest that probiotics improve feeding tolerance and further support that very preterm infants may benefit from probiotic supplementation.
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  • Mitha, A, et al. (författare)
  • Maternal body mass index in early pregnancy and severe asphyxia-related complications in preterm infants
  • 2020
  • Ingår i: International journal of epidemiology. - : Oxford University Press (OUP). - 1464-3685 .- 0300-5771. ; 49:5, s. 1647-1660
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundLittle is known about the associations between maternal body mass index (BMI) and asphyxia-related morbidity in preterm infants (&lt;37 weeks). We aimed to investigate associations between maternal BMI in early pregnancy and severe asphyxia-related neonatal complications in preterm infants (&lt;37 weeks) and to examine whether possible associations were mediated by overweight- or obesity-related complications.MethodsIn this Swedish population-based cohort of 62 499 singleton non-malformed preterm infants born from 1997 to 2011, risks of low Apgar scores (0–3) at 5 and 10 minutes, neonatal seizures and intraventricular haemorrhage (IVH) were estimated through two analytical approaches. In the conventional approach, the denominator for risk was all live births at a given gestational age. In the fetuses-at-risk (FAR) approach, the denominator for risk was ongoing pregnancies at a given gestational age.ResultsUsing the conventional approach, adjusted risk ratios per 10-unit BMI increase were 1.32 [95% confidence interval (CI) 1.13–1.54] and 1.37 (95% CI 1.12–1.67) for low Apgar scores at 5 and 10 minutes, respectively; 1.28 (95% CI 1.00–1.65) for neonatal seizures; and 1.18 (95% CI 1.01–1.37) for IVH. Using the FAR approach, corresponding risks were higher. These associations varied by gestational age (&lt;32 and 32–36 weeks). Associations between maternal BMI and asphyxia-related outcomes were partly mediated through lower gestational age.ConclusionsIncreasing maternal BMI in early pregnancy is associated with increased risks of severe asphyxia-related complications in preterm infants. Our findings add to the evidence to support interventions to reduce obesity in woman of reproductive age.
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  • Nauck, M., et al. (författare)
  • Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study
  • 2013
  • Ingår i: Diabetes, Obesity and Metabolism. - : Wiley. - 1462-8902. ; 15:3, s. 204-212
  • Tidskriftsartikel (refereegranskat)abstract
    • Aims To investigate efficacy and safety of dual therapy with liraglutide and metformin in comparison to glimepiride and metformin, and metformin monotherapy over 2?years in patients with type 2 diabetes. Methods In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n?=?1091) were randomized (2?:?2?:?2?:?1:?2) to liraglutide (0.6, 1.2 or 1.8?mg once-daily), placebo or glimepiride; all with metformin. Patients were enrolled if they were 1880?years old with HbA1c 7.011.0% (previous monotherapy =3?months), or 7.010.0% (previous combination therapy =3?months), and body mass index =40?kg/m2. Patients completing the 26-week double-blinded phase could enter an 18-month open-label extension. Results HbA1c decreased significantly with liraglutide (0.4% with 0.6?mg, 0.6% with 1.2 and 1.8?mg) versus 0.3% increase with metformin monotherapy (p?
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