6/28/23, 12:23 AM CSG Captopril Trial Pathway Feedback Search Clinical Topics Home Studies CSG Captopril Trial CSG Captopril Trial Disease Disease Disease Diabetes mellitus type 1 Diabetes mellitus type 2 Diabeti 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 N = 409 53.0% male 409 patients (192 female, 217 male) Inclusion criteria: patients with insulin-dependent diabetic nephropathy Key exclusion criteria: pregnancy, white-cell count < 2500/mL , 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 21.3 21.3 % 16.0 % 12 1 https://web.pathway.md/studies/recA5sckj2TMm2xph 1/2 6/28/23, 12:23 AM CSG Captopril Trial Pathway 12.1 10.7 % Significant increase 5.3 % NNH = 11 0.0 % Captopril Placebo 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. Open reference URL https://web.pathway.md/studies/recA5sckj2TMm2xph 2/2