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Benefit of glinides is not proven
Date:6/18/2009

purpose of the investigation commissioned by the Federal Joint Committee (G-BA) was to assess the benefit of long-term use of glinides. IQWiG and its external experts identified a total of 10 relevant trials, 8 of them on repaglinide and 2 on nateglinide. Trials with a minimum treatment duration of 24 weeks were included. With this observation period, it is assumed that the patients are well-adjusted to the new drug.

None of the included trials lasted longer than 14 months. There were therefore no long-term trials on either repaglinide or nateglinide that were designed to investigate late complications of diabetes. This is surprising, particularly as both substances have been approved for over 8 years. Thus, the authors of the final report have come to the conclusion that, owing to a lack of trials, a benefit from glinides is not proven. It is suggested that research is needed and further trials are called for that investigate the long-term use of glinides.

No conclusions possible on important patient-relevant outcomes

Important questions remained unanswered even in the analysis of the available trials. This was particularly due to the fact that many of the outcomes established in the Institute's report plan, such as avoiding late complications, health-related quality of life and patient satisfaction, were not investigated at all in the available trials.

The data on the investigated outcomes, moreover, did not permit a definite conclusion on whether patients profit from treatment with glinides. This was because some of the data were not presented with sufficient transparency or because the trials were susceptible to bias.

Thus, according to the conclusion drawn by IQWiG and its external experts, there is no proof of either benefit or additional benefit compared to other drug therapy options.

Comparison with other therapies was only partially possible

For the majority of therapy alternati
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Contact: Dr. Anna-Sabine Ernst
info@iqwig.de
49-022-135-685
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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