Linagliptin: Once again, no proof of add... (but two different treatment strategies a...)

Linagliptin: Once again, no proof of added benefit

Date:1/30/2013

but two different treatment strategies as well: whereas the glimepiride dose in the first phase of the study was to be adjusted (i.e. increased) until a near-normal level of blood glucose (HbA1c) was reached, no definite target value was specified in the linagliptin group. It is therefore unclear whether possible differences in the treatment results are attributable to the drugs or the treatment strategy, i.e. the unilateral specification of a target value. This study is therefore also unsuitable for deriving an added benefit.

Intensive reduction in blood glucose can increase the risk of strokes

Although it is not relevant for the assessment of the added benefit of linagliptin, this study nevertheless provided important information: in the first phase of the study, in which the blood glucose levels in the glimepiride group were rapidly reduced to the desired near-normal range, not only was the number of hypoglycaemic episodes (times when blood glucose was too low) increased, but also the number of serious cerebral events, i.e. strokes, was far higher than in the comparator group, in which no target blood glucose value was specified.

"The results show once again that an intensive reduction in blood glucose values is achieved at the expense of substantial risks to health", commented Jrgen Windeler, the Director of IQWiG. "Furthermore, this result is to be attributed to the different treatment strategies rather than the drugs".

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.

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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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