CSG Captopril Trial
Trial question
What is the role of captopril in patients with insulin-dependent diabetic nephropathy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 409
409 patients (192 female, 217 male).
Inclusion criteria: patients with insulin-dependent diabetic nephropathy.
Key exclusion criteria: pregnancy, white-cell count < 2500/mL³, congestive HF (NYHA class III or worse), and a serum potassium concentration ≥ 6 mmol/L.
Interventions
N=207 captopril (25 mg TID).
N=202 placebo (matching tablet TID).
Primary outcome
Doubling of serum creatinine concentration
12.1%
21.3%
21.3 %
16.0 %
10.7 %
5.3 %
0.0 %
Captopril
Placebo
Significant
increase ▲
NNH = 10
Significant increase in doubling of serum creatinine concentration (12.1% vs. 21.3%; RR 48, 95% CI 16 to 69).
Secondary outcomes
Significant decrease in death, dialysis, or renal transplantation (11.1% vs. 21%; RR 0.5, 95% CI 0.3 to 0.82).
Safety outcomes
No significant difference in drug compliance at one year (92% vs. 95%).
Conclusion
In patients with insulin-dependent diabetic nephropathy, captopril was superior to placebo with respect to doubling of serum creatinine concentration.
Reference
Lewis EJ, Hunsicker LG, Bain RP et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. The Collaborative Study Group. N Engl J Med. 1993 Nov 11;329(20):1456-62.
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