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Linagliptin: Once again, no proof of added benefit
Date:1/30/2013

e for metformin if the latter is not tolerated by patients or should not be taken because of impaired kidney function. In this case of monotherapy, the G-BA states that linagliptin is to be compared with a drug from the sulfonylurea class.

The second situation is dual therapy in which linagliptin is combined with metformin. This combination is indicated if treatment with metformin alone is insufficient to control blood glucose levels. In the case of such dual therapy with linagliptin, the added benefit is to be assessed in comparison with the combination of metformin and a sulfonylurea (glibenclamide or glimepiride).

The third situation is triple therapy in which a combination of linagliptin, metformin and a sulfonylurea is given. This is indicated if dual therapy of metformin and a sulfonylurea does not provide adequate treatment. The ACT for triple therapy was specified by the G-BA as a combination of human insulin and metformin.

Direct comparison with placebo is not sufficient

For monotherapy and triple therapy, the company did not submit any studies that tested linagliptin against the ACT. Although it presented the results of placebo-controlled studies in its dossier as supplementary information, in this case, however, the direct comparison with a dummy drug (placebo) is not suitable for proving an added benefit of one drug over another treatment.

Furthermore, the company also did not cite any studies that could be used for an indirect comparison. For methodological reasons, it did not consider that an indirect comparison could be carried out for the triple therapy.

The only study on dual therapy compared two treatment strategies

The company listed one study on dual therapy in which glimepiride and linagliptin - each combined with metformin - were tested against each other. In principle, this study could have been relevant. However, it did not simply compare two drugs with each other,
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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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