BJP-2000-BECH-421-8

Meta analysis of early treatment discontinuation data

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Unformatted text preview: er than the DSM±III criteria. We had not anticipated that this would lead to 23 non-USA trials (including around 1400 patients) being excluded. However, since the official indication for the use of SSRIs such as fluoxetine in patients with depression worldwide, including Europe, is major depression, we felt that it was not justified to change the original inclusion criteria in our protocol. The results of the analyses of the reasons for discontinuations in the trials v. placebo were as predicted, that is significantly more discontinuations in the fluoxetine-treated group due to an adverse event, and significantly more discontinuations in the placebotreated group due to lack of efficacy, with a non-significant trend for discontinuation for any reason favouring fluoxetine (see Table 4). Using the fixed effects model the test for homogeneity was significant indicating heterogeneity among the trials for the three outcomes, and visual inspection of the graphical results (not shown) suggested this was due to two trials (USAtrial±15 and USA-trial±16). We therefore decided to use a random effects model, which gave more conservative results, but removed the heterogeneity. The analysis of the reasons for discontinuation in the USA trials of fluoxetine v. TCA showed that, while receiving fluoxetine, significantly fewer patients discontinued T Table 4 able DISCUSSION DSM ^ III major depression Antidepressive responsiveness to fluoxetine in major depression A 50% reduction in the baseline HDRS±17 score was the primary outcome in our study. In the intention-to-treat analysis, both for HDRS±17 and for CGI, fluoxetine showed an advantage of approximately 15% over placebo. This is a similar result to that found in one of the first overviews comparing TCAs with placebo (Smith et al, 1969) as well as that reported in the Medical Research Council trial (Medical Research Council, 1965). The odds ratio analysis confirmed that fluoxetine was significantly superior to placebo, although no difference was seen between the USA trials and non-USA trials...
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