Renal and Retinal Effects of Enalapril and Losartan in Type 1 Diabetes
| العنوان: | Renal and Retinal Effects of Enalapril and Losartan in Type 1 Diabetes |
|---|---|
| المؤلفون: | Sandra Donnelly, Bernard Zinman, Michael Mauer, Robert Gardiner, Samy Suissa, Marie Claire Gubler, Keith N. Drummond, Ronald Klein, Trudy Strand, Paul Goodyer, Alan R. Sinaiko |
| المصدر: | New England Journal of Medicine. 361:40-51 |
| بيانات النشر: | Massachusetts Medical Society, 2009. |
| سنة النشر: | 2009 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Kidney Glomerulus, Urology, Angiotensin-Converting Enzyme Inhibitors, Kaplan-Meier Estimate, Placebo, Losartan, Retina, Article, Nephropathy, Renin-Angiotensin System, Double-Blind Method, Enalapril, Internal medicine, medicine, Albuminuria, Humans, Diabetic Nephropathies, Diabetic Retinopathy, business.industry, General Medicine, medicine.disease, Angiotensin II, Diabetes Mellitus, Type 1, Logistic Models, Endocrinology, Mesangial Cells, ACE inhibitor, Disease Progression, Female, Microalbuminuria, business, Angiotensin II Type 1 Receptor Blockers, Follow-Up Studies, Glomerular Filtration Rate, Retinopathy, medicine.drug |
| الوصف: | Background Nephropathy and retinopathy remain important complications of type 1 diabetes. It is unclear whether their progression is slowed by early administration of drugs that block the renin–angiotensin system. Methods We conducted a multicenter, controlled trial involving 285 normotensive patients with type 1 diabetes and normoalbuminuria and who were randomly assigned to receive losartan (100 mg daily), enalapril (20 mg daily), or placebo and followed for 5 years. The primary end point was a change in the fraction of glomerular volume occupied by mesangium in kidney-biopsy specimens. The retinopathy end point was a progression on a retinopathy severity scale of two steps or more. Intention-to-treat analysis was performed with the use of linear regression and logistic-regression models. Results A total of 90% and 82% of patients had complete renal-biopsy and retinopathy data, respectively. Change in mesangial fractional volume per glomerulus over the 5-year period did not differ significantly between the placebo group (0.016 units) and the enalapril group (0.005, P = 0.38) or the losartan group (0.026, P = 0.26), nor were there significant treatment benefits for other biopsy-assessed renal structural variables. The 5-year cumulative incidence of microalbuminuria was 6% in the placebo group; the incidence was higher with losartan (17%, P = 0.01 by the log-rank test) but not with enalapril (4%, P = 0.96 by the log-rank test). As compared with placebo, the odds of retinopathy progression by two steps or more was reduced by 65% with enalapril (odds ratio, 0.35; 95% confidence interval [CI], 0.14 to 0.85) and by 70% with losartan (odds ratio, 0.30; 95% CI, 0.12 to 0.73), independently of changes in blood pressure. There were three biopsy-related serious adverse events that completely resolved. Chronic cough occurred in 12 patients receiving enalapril, 6 receiving losartan, and 4 receiving placebo. Conclusions Early blockade of the renin–angiotensin system in patients with type 1 diabetes did not slow nephropathy progression but slowed the progression of retinopathy. (ClinicalTrials.gov number, NCT00143949.) |
| تدمد: | 1533-4406 0028-4793 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4ee2bdec297f492a790bcf1956b8b052Test https://doi.org/10.1056/nejmoa0808400Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4ee2bdec297f492a790bcf1956b8b052 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15334406 00284793 |
|---|