Tuesday, December 08, 2009

More evidence that sulfonylureas are associated with increased mortality

This isn't new. In fact I've mentioned it here and in multiple other posts, but Internal Medicine News now reports:

Four widely prescribed oral sulfonylurea drugs are associated with significantly increased risk of all-cause mortality compared with metformin in type 2 diabetic patients with a history of MI, according to a comprehensive Danish national cohort study.

The study included all Danish adults with a prior MI who started on oral glucose-lowering monotherapy during 1997-2006. The conclusion: Glimepiride, glyburide, glipizide, and tolbutamide were associated with 33%-43% higher mortality risk than was metformin, Dr. Tina Ken Schramm said at the annual congress of the European Society of Cardiology.

These drugs have carried a cardiovascular warning for years. Here's the one for Amaryl:

Special Warning On Increased Risk Of Cardiovascular Mortality

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term, prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19 supp. 2: 747-830, 1970).

UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of AMARYL (glimepiride tablets) and of alternative modes of therapy.

Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

The popular media have never been interested in this because these are generic drugs and Big Pharma is not involved.

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