- The Microalbuminuria, Cardiovascular, and Renal Outcomes (MICRO-HOPE) substudy of the HOPE trial compared the effects of the ACEI ramipril with those of placebo in patients with diabetes. As in the main study, all patients had a history of a cardiovascular event and at least one additional risk factor in addition to diabetes, but no clinical proteinuria, congestive heart failure (CHF), or low left ventricular ejection fraction. A total of 3577 patients were randomized to ramipril (10 mg/d) or placebo. The Micro-HOPE study was stopped 6 months early (after 4.5 years) by the independent data safety and monitoring board because an interim analysis revealed a consistent benefit of ramipril therapy.
- The main outcome of the substudy, overt nephropathy, was reduced by 24% among patients treated with ramipril compared with placebo.
- The primary endpoint of the HOPE trial—the combined incidence of MI, stroke, or cardiovascular death—was reduced by 25% (P=0.0004) in the MICRO-HOPE substudy. This reduction was maintained when the data were adjusted for the small reduction in BP in the ramipril group. Treatment with ramipril also significantly reduced individual components of the combined endpoint. Additionally, the risk for development of CHF was reduced by 20% among ramipril-treated patients, compared with the placebo group.
- This study demonstrated that ACE inhibition with ramipril has cardioprotective and renoprotective effects in patients with diabetes.
The HOPE Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and Micro-HOPE substudy. Lancet. 2000;355:253-259.