Oral antidiabetics without added benefit?

IQWiG sees little added benefit in gliptines

02/07/2013

The Institute for Quality and Efficiency in Health Care (IQWiG) comes in a review of the existing market of gliptins to a devastating judgment. The reviewed drugs used against diabetes show in most cases no provable added value, according to the statement of the institute. We found that manufacturers have not yet been able to prove an improvement in antidepressant therapy in studies, "said the head of IQWiG, adding: „Here there is an urgent need to catch up.“

The IQWiG has reviewed the three drugs vildagliptin, sitagliptin and saxagliptin as monotherapy and in combination with the drug metformin as part of its assessment. The active substances were approved in Germany between the years 2007 and 2009 for the treatment of people with diabetes mellitus type 2 and should help, „if those concerned with diet change and exercise alone can not lower their blood sugar sufficiently or not tolerate other oral antidiabetics“, reports the IQWiG. The evaluation of the antidiabetic drugs showed that „with the exception of sitagliptin from the study data presented for any of the gliptins an added benefit“ is recognizable, so the conclusion of the institute. Many of the studies carried out so far are not suitable for answering the question of added benefit.

Lack of long-term studies criticized
According to the IQWiG, with the exception of one indication of sitagliptin, none of the gliptins could be considered to have an added benefit. This is „An unsatisfactory result for all concerned - not only for the manufacturers, but also for the patients and their treating physicians“, stressed the head of the IQWiG, Jürgen Windeler. The IQWiG expressed particular criticism at the lack of long-term studies on the tested antidiabetic drugs. „For none of the evaluated active substances, long-term studies have been presented in the dossiers, even though some have been on the market since 2007“, so the message of the institute. Thomas Kaiser, Head of the Department of Pharmaceutical Assessment at the IQWiG, said: „It is completely unacceptable that, especially for medicines that patients have to take for very long periods of time, there are no data available on their long-term effects, even several years after their approval.“ Especially since the long-term prevention of micro- and macrovascular complications is an important goal of diabetes therapy.

Altered benefit assessment of the examined gliptins?
Although the manufacturer of the drug saxagliptin, which has been approved in Germany since 2009, announced shortly before the completion of the stock market valuation that it would soon present the results of a long-term study, these were not yet available for evaluation, reports the IQWiG. Especially incomprehensible „the absence of long-term data, especially for sitagliptin and vildagliptin, which were the first gliptins to be approved in Europe in March and September 2007 respectively“, IQWiG continues. Since the current dossier assessment is part of the overall procedure for the early benefit assessment under the leadership of the Joint Federal Committee (G-BA), the examined gliptines now face a changed assessment of their added benefit. (Fp)

Picture credits: Thomas Siepmann