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Added benefit of aclidinium bromide is not proven
Date:1/30/2013

inium is a long-term treatment, a reliable benefit assessment requires studies that last for at least 6 months. However, for the direct comparison of aclidinium with tiotropium, the manufacturer submitted 2 studies that only lasted for 2 and 6 weeks respectively. The dossier thus contained no studies relevant for the direct comparison.

Placebo studies for indirect comparison

For the indirect comparison, the manufacturer used studies that compared aclidinium and tiotropium with a dummy drug (placebo) in each case. But of a total of 24 studies (3 on aclidinium, 21 on tiotropium) only 14 were suitable for the assessment, because the others had lasted for less than 6 months.

Results for indirect comparison incomprehensible

When comparing the submitted results on the placebo studies with the original sources, IQWiG found substantial differences: on the one hand, some of the manufacturer's information did not match the corresponding original data. On the other hand, it was often unclear whether data emanated from the manufacturer or from another source and how they had been calculated. Much of the information in the manufacturer's dossier (especially about patient numbers and confidence intervals) could not be traced in the original sources.

Due to these deficiencies, it was impossible to check and therefore also to interpret the results presented in the dossier for almost all outcomes regarding benefit. In addition, the manufacturer repeatedly did not consider study results on relevant outcomes (exacerbations, mortality, quality of life), although they were to be found in the original sources. Because of these deficiencies, an added benefit of aclidinium on the basis of the manufacturer's dossier is not proven.

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
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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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