Double-blind, placebo-controlled comparison of the antidepressant efficacy and
tolerability of bupropion XR and venlafaxine XR.
Author(s): Hewett K, Gee MD, Krishen A, Wunderlich HP, Le Clus A, Evoniuk G, Modell JG.
Affiliation(s): GlaxoSmithKline, Pharmaceuticals, New Frontiers Science Park, Harlow, UK.
Karen.Hewett@gsk.com
Publication date & source: 2010, J Psychopharmacol. , 24(8):1209-16
Bupropion, a noradrenaline/dopamine reuptake inhibitor, and venlafaxine, a
serotonin/noradrenaline reuptake inhibitor, are both established antidepressants
with proven efficacy in randomized controlled clinical trials. The objective of
this double-blind, randomized, placebo- and active-controlled, eight-week,
flexible-dose study was to evaluate the efficacy and tolerability of the
once-daily extended-release formulations of these two antidepressants compared
with placebo. Patients with major depressive disorder were randomized to
once-daily treatment with bupropion XR 150 mg (n = 204), the extended-release
formulation of venlafaxine (venlafaxine XR) 75 mg (n = 198) or placebo (n = 189)
during weeks 1 to 4, with the option to double the dose at week 5 if response was
inadequate. In this study, bupropion XR did not demonstrate statistically
significant evidence of greater improvement from baseline compared with placebo
on week 8 Montgomery Asberg Depression Rating scale scores (primary endpoint) or
on secondary endpoints including CGI, HAM-A and responder and remitter analyses.
Descriptive statistics for venlafaxine XR indicated separation versus placebo on
MADRS total scores at week 8 and other intermediate time points, and on other
endpoints including CGI, HAM-A and responder and remitter analyses. Both active
treatments elicited improvement on the Sheehan Disability Scale and its subscales
and were generally well tolerated at the doses studied. Rates of nausea, dry
mouth, dizziness, hyperhidrosis, insomnia, constipation, tremor, anorexia and
male sexual dysfunction were elevated in the venlafaxine XR group, consistent
with its mixed serotonergic/noradrenergic mechanism. Rates of dry mouth, insomnia
and hyperhidrosis were elevated in the bupropion XR group, consistent with its
catecholaminergic mechanism.
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