Benefit of exenatide has not yet b...( Since May 2007 a new drug has been a...),Health

Since May 2007, a new drug has been available for the treatment of patients with diabetes mellitus type 2 in Germany: exenatide (trade name: Byetta), which is marketed by the manufacturer Eli Lilly. This drug was developed for patients who cannot sufficiently control their blood glucose levels with conventional oral antidiabetic agents, and who therefore need additional therapy with another oral antidiabetic agent or insulin. Like insulin, exenatide is also injected subcutaneously. According to current evidence, the blood-glucose lowering effect of exenatide has been demonstrated, but is not superior to the corresponding effect of insulin. Moreover, there is no evidence to show that the improved glycaemic control contributes to a reduction in the rate of late complications of diabetes. The long-term beneficial or detrimental effects of this new drug are still unclear.

This is the conclusion of a report by the German Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, which was published in September 2007 and for which an English-language summary is now available.

Therapy only possible in combination with oral antidiabetics

The Federal Joint Committee commissioned IQWiG to prepare a rapid report to assess whether exenatide has a patient-relevant benefit. Exenatide is not permitted to be used as monotherapy. The drug is only approved for combination therapy with metformin and/or sulfonylurea. Consequently, IQWiG searched for studies that compared exenatide as add-on therapy to these oral antidiabetics, either with add-on placebo or with other add-on blood-glucose lowering drugs.

Five randomised controlled trials were identified that could be included in the evaluation. In 3 of these studies, patients in the control group received a placebo (placebo-controlled); in the 2 other studies, patients received insulin (active-controlled). In addition, patients in all treatment groups received metformin and/or sulfonylurea. Only s
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