RENAAL
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
63.0% male
N = 1513
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
43.5
47.1
47.1 %
35.3 %
23.6 %
11.8 %
0.0 %
Losartan
Placebo
Significant
increase ▲
NNH = 27
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.
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