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

¹ Bristol-Myers Squibb, Princeton, New Jersey
² Food and Drug Administration, Rockville, Maryland

Address correspondence and reprint requests to Dennis R. Cryer, MD, Bristol-Myers Squibb Company, 777 Scudders Mill Rd., Plainsboro, NJ 08536. E-mail: dennis.cryer{at}bms.com

OBJECTIVE—Metformin was approved by the Food and Drug Administration in 1995 subject to the conduct of a randomized trial to evaluate the risk of lactic acidosis or other serious adverse events (SAEs) with this agent, under usual care conditions.

RESEARCH DESIGN AND METHODS—The Comparative Outcomes Study of Metformin Intervention versus Conventional (COSMIC) Approach Study was a randomized, open-label, active-comparator, parallel-group, 1-year trial in type 2 diabetic patients suboptimally controlled on diet or sulfonylurea. Patients received metformin (n = 7,227) or other usual care treatments (n = 1,505). The primary end point was the incidence of SAEs, death, and hospitalization.

RESULTS—SAEs occurred in 10.3% (95% CI 9.6–11.1%) of the metformin group and in 11.0% (9.5–12.7%) of the usual care group (P = 0.431). Lactic acidosis did not occur. All-cause mortality (1.1% [0.9–1.4%] vs. 1.3% [0.8–2.0%], P = 0.596) and hospitalization (9.4% [8.8–10.1%] vs. 10.4% [8.9–12.1%], P = 0.229) were similar between groups.

CONCLUSIONS—The incidence of SAEs was similar between groups. Lactic acidosis was not observed. Metformin may be safely prescribed for type 2 diabetes if contraindications and warnings are respected. This study demonstrates the utility of large, simple trials for risk evaluation of treatments for common diseases.

Abbreviations: ADE, adverse drug experience • AE, adverse event • AST, aspartate aminotransferase • COSMIC, Comparative Outcomes Study of Metformin Intervention versus Conventional • FDA, Food and Drug Administration • SAE, serious AE

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