BJP-2000-BECH-421-8

In the intention to treat analysis both for hdrs17

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Unformatted text preview: . Improved safety acceptance of fluoxetine In this meta-analysis the results for discontinuation due to adverse reactions were evaluated by the intention-to-treat analysis. Compared with placebo we observed that significantly more patients ceased treatment with fluoxetine due to adverse events while significantly more patients dropped out on placebo due to lack of efficiency. This is reflected in the relatively lower differences in antidepressive improvement in the intention-to-treat analysis. However, compared with patients in the TCA groups, in the USA trials, and to a lesser extent the non-USA trials, we observed that significantly fewer trials in the fluoxetine group stopped treatment due to adverse events. This seems to explain that the intention-to-treat analysis for the USA trials favoured fluoxetine while that for the non-USA trials did not. However, when combined, significantly fewer patients on fluoxetine compared with those on TCAs discontinued treatment due to adverse events. These results are in agreement with results of the meta-analyses published by Andersen & Tomenson (1995) and Hotopf et al (1997). In the latter meta-analysis, Hotopf et al analysed the `old' TCAs (e.g. Meta-analysis of reasons for early treatment discontinuation Analysis subgroup Reason for early treatment discontinuation Adverse event Odds ratio 95% CI Lack of efficacy Any reason Odds ratio 95% CI Odds ratio 95% CI USA trials v. placebo 1.96* (1.42^2.72) 0.38* (0.29^0.50) 0.84 (0.69^1.02) USA trials v. TCA 0.47* (0.36^0.61) 1.27 (0.88^1.82) 0.64* (0.52^0.80) Non-USA trials v. TCA 1.25 (0.64^2.46) 1.06 (0.54^2.10) 1.16 (0.78^1.70) Combined trials v. TCA 0.53* (0.42^0.67) 1.22 (0.89^1.62) 0.75* (0.62^0.90) *P40.01; TCA, tricyclic antidepressant. 426 F LUOX E T IN E v . P L A C E B O A N D T C A s I N S HO R T-T E R M T R E AT M E N T OF D E P R E S S I ON v. IN HOR USA 1 USA 2 CLINICAL IMPLICATIONS USA 3 USA 4 The different statistical analyses converged in showing that fluoxetine...
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