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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
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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- Summer '12