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Preliminary report on antidepressants published
Date:6/10/2009

On 10 June 2009, the Institute for Quality and Efficiency in Health Care (IQWiG) presented the preliminary results of its benefit assessment of certain newer antidepressants. The project commissioned by the Federal Joint Committee (G-BA) is concerned with assessing the benefit of three agents, reboxetine, mirtazapine and bupropion XL in adult patients with depression, according to the German drug approval status. Interested parties and institutions may submit written comments on the preliminary report up until 9 July.

Reboxetine: no proof of benefit

The assessment produced different results for the three agents. According to a literature search performed by the Institute, reboxetine (manufacturer: Pfizer) was tested in at least 16 trials on approximately 4600 patients with depression. However, the Institute only had access to data on approximately 1600 of these patients. If the unpublished data are not included, there is a high risk of incorrectly estimating the benefit and harm of this agent. IQWiG has therefore come to the preliminary conclusion that no proof of benefit from treatment with reboxetine can be deduced from the data currently available.

Mirtazapine: results must be viewed with reservation

In the search for trials on mirtazapine (Essex Pharma), it was found that this agent had been tested in at least 31 trials that could be potentially relevant to the report. However, the Institute only had access to 27 evaluable trials. As it is also possible in this case that the results of the assessment may change if all data became available, all results presented by the Institute must be viewed with reservation.

In numerous comparisons with other antidepressants, mirtazapine showed no proof of superiority. Only when compared to placebo was there proof that in acute treatment more patients experienced an improvement of depression when they were treated with mirtazapine. However, the prognosis for a
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Contact: Dr. Anna Sabine Ernst
anna-sabine.ernst@iqwig.de
049-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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