3 - 5 In addition, results of the UK Prospective Diabetes Study 6 indicate that metformin monotherapy leads to reductions in diabetes mellitus–related end points, in the diabetes mellitus–related mortality rate, and in the total mortality rate compared with insulin use, sulfonylurea therapy, or diet alone. 1, 2 Aside from its effect on carbohydrate metabolism, metformin treatment is thought to have other positive effects, such as weight loss or stabilization of weight gain. METFORMIN hydrochloride is a biguanide that has been used to treat type 2 diabetes mellitus for more than 40 years. There was no difference in lactate levels for metformin compared with placebo or other nonbiguanide therapies.Ĭonclusion There is no evidence to date that metformin therapy is associated with an increased risk of lactic acidosis or with increased levels of lactate compared with other antihyperglycemic treatments if the drugs are prescribed under study conditions, taking into account contraindications. Using Poisson statistics with 95% confidence intervals, the probable upper limit for the true incidence of lactic acidosis in the metformin and nonmetformin groups was 8.1 and 9.9 cases per 100 000 patient-years, respectively.

Results Pooled data from 194 studies revealed no cases of fatal or nonfatal lactic acidosis in 36 893 patient-years in the metformin group or in 30 109 patients-years in the nonmetformin group. In a second analysis, lactate levels were measured as a net change from baseline or as mean treatment values for metformin and comparison groups. The incidence of fatal and nonfatal lactic acidosis was recorded as cases per patient-years for metformin treatment and for placebo or other treatments. Methods A comprehensive search was performed to identify all comparative trials or observational cohort studies published between January 1, 1959, and March 31, 2002, that evaluated metformin therapy, alone or in combination with other treatments, for at least 1 month. The true incidence of fatal and nonfatal lactic acidosis associated with metformin use is not known.

Shared Decision Making and Communicationīackground Metformin therapy for type 2 diabetes mellitus has been shown to reduce total mortality rates compared with other antihyperglycemic treatments but is thought to increase the risk of lactic acidosis.

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