BJP-2000-BECH-421-8

In hor received placebo and 686 had received tcas

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Unformatted text preview: in the placebo-treated group and 686 in the TCA-treated group). For the non-USA trials, data were analysed from 13 single- and multi-centre, randomised, double-blind trials in which fluoxetine was compared with a TCA in 643 patients (i.e. without non-USA trial 10; see Table 1b). Of these 643 patients, 314 had received fluoxetine and 329 had received TCAs (either amitriptyline, clomipramine, dothiepin, doxepin, imipramine or maprotiline). There were no statistically significant differences between the treatment groups in the percentage of men included in the trials (approximately 40% overall), the mean age (approximately 45 years), or the baseline HDRS±17 score (total mean score approximately 22). Only one of the USA trials v. placebo included both in- and out-patients, the others included only out-patients. The dose ranges for the individual trials are shown in Tables 1a and 1b. Only two of the USA trials v. TCA included both in- and out-patients (both started with only inpatients and the protocols were amended during the trials); the other trials included only out-patients. Three non-USA trials v. TCA included only in-patients, three included only out-patients, six included both, and this was not specified for the remaining trial. The percentage of patients completing the trial was generally higher in the nonUSA trials (Table 1b) than in the USA trials (Table 1a). Table 2 Meta-analysis of patients classified as responders on the Hamilton Depression Rating Scale (HDRS ^17). An odds ratio equal to 1 means no difference between treatment groups. A value greater than 1 (HDRS^17). favours fluoxetine while a value less than 1 favours control treatment Trials Percentage of responders on HDRS^17 Log odds ratio analysis Fluoxetine Placebo Difference Odds ratio 95% CI 37.8 24.2 13.6 2.07* (1.69^2.53) Efficacy 56.0 34.6 21.4 2.44* (1.97^3.04) End-point 44.5 27.7 16.8 2.22* (1.83^2.70) (0.94^1.48) USA trials v. placebo Intention to treat USA trials v. TCA Intention-to-treat 39.5 35.6 3.9 1.18 Efficacy 58.2 60.6 72.4 0.93 (0.71^1.22) End-point 45.5 43.0 2.5 1.10 (0.88^1.37) Intention to treat 39.5 44.1 74.6 0.81 (0.58^1.13) Efficacy 56.3 65.9 79.6 0.62 (0.42^0.92) End...
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