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 ondiet 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.
RCT Entities:
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 diabeticpatients 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.
Authors: Savas Sipahi; Yalcin Solak; Seyyid Bilal Acikgoz; Ahmed Bilal Genc; Mehmet Yildirim; Ulku Yilmaz; Ahmet Nalbant; Ali Tamer Journal: Int Urol Nephrol Date: 2016-04-21 Impact factor: 2.370
Authors: Fulvio Stacul; Aart J van der Molen; Peter Reimer; Judith A W Webb; Henrik S Thomsen; Sameh K Morcos; Torsten Almén; Peter Aspelin; Marie-France Bellin; Olivier Clement; Gertraud Heinz-Peer Journal: Eur Radiol Date: 2011-08-25 Impact factor: 5.315
Authors: Elizabeth Selvin; Shari Bolen; Hsin-Chieh Yeh; Crystal Wiley; Lisa M Wilson; Spyridon S Marinopoulos; Leonard Feldman; Jason Vassy; Renee Wilson; Eric B Bass; Frederick L Brancati Journal: Arch Intern Med Date: 2008-10-27
Authors: M Al-Maatouq; M Al-Arouj; S H Assaad; S N Assaad; S T Azar; A A K Hassoun; N Jarrah; S Zatari; K G M M Alberti Journal: Int J Clin Pract Date: 2010-01 Impact factor: 2.503