Reboxetine, the first selective noradrenaline reuptake inhibitor antidepressant: Efficacy and tolerability in 2613 patients

Abstract

INTRODUCTION: Reboxetine is the first available selective noradrenaline re-uptake inhibitor (selective NRI). This paper gives an overview of its antidepressant efficacy and tolerability in eight randomized double-blind, multicentre clinical trials. The clinical profile of reboxetine is also compared with that of the tricyclic antidepressants (TCAs) desipramine and imipramine and the selective serotonin re-uptake inhibitor (SSRI) fluoxetine. METHODS: Pooled data were analysed from seven short-term (4 - 8 weeks) and one long-term (up to 1 year) trials comparing reboxetine with placebo, imipramine, desipramine or fluoxetine. The tolerability of reboxetine was evaluated in 2613 patients with major depression or dysthymia. Data from 1959 patients with major depressive disorder were included to assess drug efficacy. Efficacy was principally assessed using the Hamilton Depression Rating Scale (HAM-D). RESULTS: Reboxetine was more effective than placebo in three of four short-term trials, and it was as effective as fluoxetine, imipramine and desipramine. In long-term treatment, reboxetine was more effective than placebo in preventing relapse ( S 50% increase in HAM-D) and recurrence (HAM-D total score h 10). In a subset of severely depressed patients, reboxetine was as effective as imipramine and significantly more effective than fluoxetine. Reboxetine was as effective as imipramine in the elderly, but better tolerated. The most common adverse events among the 1503 patients (adults and elderly) who received reboxetine were dry mouth (22%), constipation (15%), sweating (12%) and insomnia (11%). Overall, reboxetine was well tolerated, as well as the SSRI fluoxetine and better than the TCAs imipramine and desipramine. CONCLUSIONS: Reboxetine is effective and well tolerated in the short and long-term treatment of depression. It is as well tolerated as fluoxetine and better than imipramine and desipramine. ( Int J Psych Clin Pract 2000; 4: 201 - 208)