Antidepressant efficacy and tolerability of the selective norepinephrine reuptake inhibitor reboxetine: a review.
Reboxetine is a unique selective norepinephrine reuptake inhibitor (NRI) with proven antidepressant efficacy in pharmacologic and biochemical tests predictive of antidepressant properties. Comprehensive clinical trials, including 8 placebo-controlled and/or active treatment-controlled studies, plus 4 open studies, have assessed the short-term and long-term efficacy and tolerability of reboxetine in patients with major depressive disorders and dysthymia. Results from a total of 690 patients who entered 5 open or placebo-controlled studies are summarized in this paper. Four hundred forty-nine patients with a diagnosis of either major depressive disorder or dysthymia were treated with reboxetine in these clinical studies of 4 weeks' to 12 months' duration. In a 6-week placebo-controlled study, clinically significant improvement (> or = 50% reduction in Hamilton Rating Scale for Depression total 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 3 long-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, and there were no clinically significant changes in vital signs or laboratory parameters. The first in its class, reboxetine, a selective NRI, will provide a valuable addition to the existing armamentarium of agents used in the treatment of depression.
Burrows
G D
GD
Department of Psychiatry, University of Melbourne, Heidelberg, Victoria, Australia.
Maguire
K P
KP
Norman
T R
TR
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000367:Age Factors; D000368:Aged; D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004334:Drug Administration Schedule; D019263:Dysthymic Disorder / Q000188:drug therapy / Q000523:psychology; D006801:Humans; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic; D009638:Norepinephrine / Q000037:antagonists & inhibitors; D000077593:Reboxetine; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D009025:Morpholines; D000077593:Reboxetine; D009638:Norepinephrine