6/29/23, 1:10 AM RENAAL Pathway Feedback Search Clinical Topics Home Studies RENAAL RENAAL Disease Disease Chronic kidney disease Diabetes mellitus type 2 Trial question What is the role of losartan in patients with T2DM and diabetic nephropathy? Study design Multi-center Double blinded RCT Population Characteristics of study participants 37.0% female N = 1513 63.0% male 1513 patients (557 female, 956 male) Inclusion criteria: patients with T2DM and diabetic nephropathy Key exclusion criteria: diagnosis of T1DM or nondiabetic renal disease, including renal artery stenosis, myocardial infarction, CABG within the previous month, cerebrovascular accident or percutaneous transluminal coronary angioplasty within the previous six months Interventions N=751 losartan (50 to 100 mg once daily in addition to conventional antihypertensive treatment) N=762 placebo (matching placebo daily plus conventional antihypertensive treatment) Primary outcome Death, end-stage renal renal disease, or doubling of serum creatinine https://web.pathway.md/studies/recC7nfcGcEOvidjG 1/2 6/29/23, 1:10 AM RENAAL Pathway 47.1 % 47.1 43.5 35.3 % 23.6 % Significant increase 11.8 % NNH = 28 0.0 % Losartan Placebo Significant increase in death, end-stage renal renal disease, or doubling of the serum creatinine (43.5% vs. 47.1%; RR 16, 95% CI 2 to 28) Secondary outcomes Significant increase in first hospitalization from HF (11.9% vs. 16.7%; RR 32, 95% CI 9.68 to 54.32) Significant increase in end stage renal disease (19.6% vs. 25.5%; RR 28, 95% CI 11 to 42) Safety outcomes Significant differences in reduction in the level of proteinuria with losartan compared with placebo (RR 35%, p < 0.001). Conclusion In patients with T2DM and diabetic nephropathy, losartan was superior to placebo with respect to death, end-stage renal renal disease, or doubling of the serum creatinine. Reference Brenner BM, Cooper ME, de Zeeuw D et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001 Sep 20;345(12):861-9. Open reference URL https://web.pathway.md/studies/recC7nfcGcEOvidjG 2/2