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, MI, 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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