Antidepressant Efficacy and Tolerability of the Selective Norepinephrine Reuptake Inhibitor Reboxetine: A Review

Reboxetine is a unique selective norepinephrine reuptake inhibitor (NRI) with proven antidepressantefficacy in pharmacologic and biochemical tests predictive of antidepressant properties. Comprehensiveclinical trials, including 8 placebo-controlled and/or active treatment-controlled studies, plus4 open studies, have assessed the short-term and long-term efficacy and tolerability of reboxetine inpatients with major depressive disorders and dysthymia. Results from a total of 690 patients whoentered 5 open or placebo-controlled studies are summarized in this paper. Four hundred forty-ninepatients with a diagnosis of either major depressive disorder or dysthymia were treated with reboxetinein these clinical studies of 4 weeks’ to 12 months’ duration. In a 6-week placebo-controlledstudy, clinically significant improvement (≥ 50% reduction in Hamilton Rating Scale for Depressiontotal score) was observed at last assessment in 74% of reboxetine-treated patients compared with 20%of patients in the placebo group. Similar results were observed in the 6-week run-in phases of the 3long-term studies, where the efficacy of reboxetine was maintained over the 12-month study period.Reboxetine was well tolerated; adverse events reported were mainly mild to moderate in severity, andthere were no clinically significant changes in vital signs or laboratory parameters. The first in itsclass, reboxetine, a selective NRI, will provide a valuable addition to the existing armamentarium ofagents used in the treatment of depression.