IQWiG sees hardly any additional benefit with gliptins
The Institute for Quality and Efficiency in Health Care (IQWiG) has reached a devastating judgment in an assessment of the existing Gliptine market. In most cases, the active ingredients tested against diabetes show no demonstrable added benefit, according to the institute's announcement. We had to conclude that the manufacturers have so far not been able to demonstrate that the therapy can be improved by the antidiabetic agents, explained the head of IQWiG and added: "There is an urgent need to catch up here."
The IQWiG reviewed the three drugs vildagliptin, sitagliptin and saxagliptin as monopreparations and in combination with the active ingredient metformin as part of its assessment. The active ingredients were approved in Germany between 2007 and 2009 for the treatment of people with type 2 diabetes mellitus and are intended to help "if those affected by a change in diet and exercise alone cannot lower their blood sugar sufficiently or cannot tolerate other oral antidiabetic agents", reports IQWiG. The evaluation of the antidiabetic agents showed that "with the exception of sitagliptin, there was no added benefit for any of the gliptins from the study data presented", the institute concluded. Many of the studies carried out to date 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 for sitagliptin, none of the gliptins could be attested as an added benefit. This is "an unsatisfactory result for everyone involved - not just for the manufacturers, but also for the patients and their treating doctors," emphasized the head of IQWiG, Jürgen Windeler. The IQWiG expressed particular criticism for the lack of long-term studies on the reviewed antidiabetic drugs. "Long-term studies were not included in the dossiers for any of the evaluated active substances, even though some of them have been on the market since 2007," the institute announced. Thomas Kaiser, head of the Pharmaceutical Evaluation department at IQWiG, said: “It is completely unacceptable that, especially with medications that patients have to take for very long periods of time, even years after approval, there is no data on how their use will have a long-term effect. “Especially since the long-term avoidance of micro- and macrovascular complications is an important goal of diabetes therapy.
Changed benefit assessment of the reviewed gliptins? Although the manufacturer of the active ingredient saxagliptin, which has been authorized in Germany since 2009, announced shortly before the completion of the existing market evaluation, that it would soon present results of a long-term study, the IQWiG reports that these have not yet been available for an evaluation. It is particularly incomprehensible "the lack of long-term data, especially for sitagliptin and vildagliptin, which were the first gliptins to be approved throughout Europe in March and September 2007," continued the IQWiG. Since the current dossier assessment is part of the overall process for early benefit assessment under the direction of the Federal Joint Committee (G-BA), the reviewed gliptins now face a change in the assessment of their added benefit. (fp)
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