Comparative Outcomes Study of Metformin Intervention Versus Conventional Approach The COSMIC Approach Study

摘要: OBJECTIVE —Metformin was approved by the Food and Drug Administration in 1995 subject to conduct of a randomized trial evaluate risk lactic acidosis or other serious adverse events (SAEs) with this agent, under usual care conditions. RESEARCH DESIGN AND METHODS —The Comparative Outcomes Study Metformin Intervention versus Conventional (COSMIC) Approach randomized, open-label, active-comparator, parallel-group, 1-year type 2 diabetic patients suboptimally controlled on diet sulfonylurea. Patients received metformin ( n = 7,227) treatments 1,505). The primary end point incidence SAEs, death, hospitalization. RESULTS —SAEs occurred 10.3% (95% CI 9.6–11.1%) group 11.0% (9.5–12.7%) P 0.431). Lactic did not occur. All-cause mortality (1.1% [0.9–1.4%] vs. 1.3% [0.8–2.0%], 0.596) hospitalization (9.4% [8.8–10.1%] 10.4% [8.9–12.1%], 0.229) were similar between groups. CONCLUSIONS SAEs observed. may be safely prescribed for diabetes if contraindications warnings are respected. This study demonstrates utility large, simple trials evaluation common diseases.