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Title: No Apparent Increased Risk of Lactic Acidosis Found In Type 2 Diabetics Who Take Metformin

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Arch Intern Med 2003;163:2594-2602.
11/25/2003 11:46:00 AM
By Elda Hauschildt

A systemic review of metformin use as treatment for type 2 diabetes, as prescribed under study conditions, did not reveal any increased risk of fatal or non-fatal lactic acidosis, as compared to other similar therapies, say researchers in the United States. The review covered metformin use in patients with type 2 diabetes during more than 40 years of research, between January 1959 and March 2002. Metformin was evaluated as monotherapy or in conjunction with other treatments. All trials lasted for a minimum of 1 month. "It is the underlying systemic dysfunction and not the particular treatment that is the main determinant for the appearance of lactic acidosis," concluded investigators led by Dr. Shelley Saltpeter of Stanford University School of Medicine, California. "In support of that conclusion, the results of this review reveal that there is no evidence of an increased risk of lactic acidosis associated with metformin use if it is prescribed under the study conditions, taking into account contraindications." In the reviewed trials, metformin was prescribed in daily doses of 1 gram to 3 g. Dosages were titrated clinically. The comparative treatments were: placebo, diet, insulin, glyburide, gliclazide, glipizide, glibenclamide, glimepiride, chlorpropamide, tolbutamide, acarbose, nateglinide, repaglinide, miglitol, troglitazone, rosiglitazone maleate and guar gum. Analysis studies included 126 prospective comparative trials, 56 comparative cohort studies and 12 retrospective cohort studies. Overall, 56,692 participants were followed for 67,002 patient years. There were 18,689 patients (36,893 patient years) in metformin groups and 38,003 participants (30,109 patient years) in non-metformin groups. Mean age of metformin participants was 57.1 years. Mean age of non-metformin participants was 57.2 years and in both groups, 61% were men. Mean length of trials was 2.1 years. The researchers say the probable upper limits for the true incidence of lactic acidosis was 8.1 cases per 100,000 patient years in metformin participants and 9.9 cases per 100,000 patient years in non-metformin groups. "There was no difference in lactate levels for metformin compared with placebo or other non-biguanide therapies," they state.

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