Metformin chemical structure
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Metformin

Metformin (Glucophage®, Fortamet®, Riomet®) is an anti-diabetic drug from the biguanide class (its other members are the withdrawn agents phenformin and buformin). more...

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Uses

The main use for metformin is for the treatment of diabetes mellitus, especially when it is concomitant with obesity and insulin resistance.

It is also being used increasingly in polycystic ovary syndrome (PCOS) and non-alcoholic steatohepatitis, two other diseases that feature insulin resistance; these indications are still considered experimental.

Metformin is the only anti-diabetic drug that has been proven to reduce the complications of diabetes, as evidenced in a large study of overweight patients with diabetes (UKPDS 1998).

Metformin is often prescribed to type 2 diabetes patients in combination with rosiglitazone maleate. This drug actively reduces insulin resistance, complementing the action of the metformin. In 2002, the two drugs were combined into a single product, Avandamet, marketed by GlaxoSmithKline. . In 2005, all current stock of Avandamet was seized by the FDA and removed from the market. This was due to problems at the manufacturing plants, not to any medical issues resulting from the drugs use. The drug pair continued to be prescribed separately in the absence of Avandamet itself, which was readily available by the end of that year.

Mechanism of action

Despite its therapeutic benefits, the mechanism of action of metformin is uncertain. Its mode of action appears to be reduction of hepatic gluconeogenesis; the "average" person with type 2 diabetes has three times the normal rate of gluconeogenesis. Metformin treatment reduces this by one third to two thirds. It is has been shown that metformin also decreases intestinal absorption of glucose. A third mechanism is that metformin improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Zhou et al (2001) showed that metformin stimulates the hepatic enzyme AMP-activated protein kinase.

Side-effects

The most serious side effect of metformin is lactic acidosis. However, this complication is rare if the contra-indications are followed, as it seems limited to those with impaired liver and/or kidney function.

Phenformin was withdrawn because of an increased risk of lactic acidosis (up to 60 cases per million patient-years). In recent studies it was revealed that, as long as it is not prescribed to patients who are at risk, metformin is much safer, and the risk of lactic acidosis approximates that of people who are not on the medication (Salpeter SR et al 2003).

The most common side effect of metformin is gastrointestinal upset. This includes diarrhea, cramps, nausea and vomiting. In a clinical trial of 286 subjects, 53.2% of the 141 who were given Metformin IR (as opposed to placebo) reported diarrhea, and 25.5% reported nausea/vomiting (source: Drug Facts & Comparisons 2005).

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Does treatment with metformin prolong diabetes in individuals with impaired glucose tolerance? - Diabetes - Author Abstract
From Nutrition Research Newsletter, 6/1/03

The recent Diabetes Prevention Program (DPP) reported that the incidence of diabetes in individuals with impaired glucose tolerance (IGT) was reduced by 58% when lifestyle modifications were followed and by 31% with metformin therapy as compared with placebo after a mean duration of 2.8 years of intervention. At the completion of the DPP and in order to determine whether the observed effect of metformin on the development of diabetes lasted after metformin was withdrawn, researchers tested participants taking metformin or placebo who had not developed diabetes with a repeat oral glucose tolerance test (OGTT) after a 1- to 2-week washout period during which medication was withheld.

Specifically, researchers asked the following questions: 1) Among those who did not convert to diabetes during the DPP and before washout, do the metformin and placebo groups differ in the rate of conversion to diabetes after the washout? 2) If the diabetes conversions during washout were combined with the conversions to diabetes during the trial, do the metformin and placebo groups differ in the proportion of participants who have converted to diabetes?

The subjects remained masked to their treatment assignments, were scheduled for a washout visit, and were asked to discontinue the study medication one week before the washout visit. Because of logistics of furthering the study, the actual time of drag withdrawal ranged from one to two weeks. The visit consisted of an OGTT conducted according to the DPP protocol. Following the OGTT, participants were asked to remain off the medication until they were notified whether a diabetes confirmation visit was necessary. The odds ratios for conversion to diabetes at washout for metformin versus placebo were estimated using the Mantel-Haenszel adjustment for the year of randomization. There were 1274 participants who were involved in the washout study and 52 who were not involved because they had already been diagnosed with diabetes. Prior to the washout, the odds of diabetes in the metformin group was lower than that in the placebo group (odds ration 0.66, 95% CI 0.54-0.82, P less than 0.001). Following the washout, diabetes was somewhat more frequently diagnosed in the metformin participants (1.49, 0.93-2.38, P=0.098). Combining diabetes conversions during the DPP and during the washout, diabetes was diagnosed significantly less frequently in the metformin than the placebo group (0.75, 0.62-0.92, P=0.005).

This data demonstrates that metformin decreases the risk of diabetes by 31% in this at risk population. The washout study indicates that 26% of this effect can be accounted for by a pharmacological effect of metformin that did not persist when the drug was discontinued.

W. Knowler, E. Barrett-Connor, S. Fowler, et al. Effects of withdrawal from metformin on the development of diabetes in the diabetes prevention program, Diabetes Care (26:977-980, April, 2003). Correspondence: Mark E. Molitch, MD, Diabetes Prevention Program Coordinating Center, Biostatistics Center, George Washington University, 6110 Executive Blvd., Suite 750, Rockville, MD 20852. E-mail: dppmail@biostat.bsc.gwu.edu

COPYRIGHT 2003 Frost & Sullivan
COPYRIGHT 2003 Gale Group

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