Post hoc analysis of the efficacy and safety of desvenlafaxine 50 mg/day in a
randomized, placebo-controlled study of perimenopausal and postmenopausal women
with major depressive disorder.
Author(s): Kornstein SG(1), Clayton A, Bao W, Guico-Pabia CJ.
Affiliation(s): Author information:
(1)From the 1Institute for Women's Health, Virginia Commonwealth University,
Richmond, VA; 2University of Virginia, Charlottesville, VA; and 3Pfizer Inc,
Collegeville, PA.
Publication date & source: 2014, Menopause. , 21(8):799-806
OBJECTIVE: This post hoc analysis assessed the efficacy of desvenlafaxine 50
mg/day for treating major depressive disorder in perimenopausal versus
postmenopausal women enrolled in a 10-week, double-blind, placebo-controlled
study.
METHODS: Perimenopausal and postmenopausal women (40-70 y) diagnosed with major
depressive disorder were randomly assigned to receive desvenlafaxine 50 mg/day or
placebo. Changes from baseline in the primary efficacy variable (17-item Hamilton
Rating Scale for Depression [HAM-D17] score, week 8) and in other secondary
efficacy variables (Sheehan Disability Scale and Menopause Rating Scale) were
analyzed using analysis of covariance with treatment, region, and baseline in the
model. Clinical Global Impressions-Improvement Scale was analyzed with the
Cochran-Mantel-Haenszel test. Response and remission rates were evaluated using
logistic regression with treatment, region, and baseline HAM-D17 in the model.
RESULTS: Of 426 women (desvenlafaxine, n = 216; placebo, n = 210) included in
this analysis, 135 (32%) were perimenopausal and 291 (68%) were postmenopausal at
baseline. In both subgroups, improvement from baseline in HAM-D17 scores was
significantly greater for desvenlafaxine 50 mg/day than for placebo. Menopause
status and time since menopause did not significantly affect HAM-D17 total score.
The drug-placebo difference in Sheehan Disability Scale scores was significant in
perimenopausal women (-9.3 vs. -5.1, P < 0.001) but not in postmenopausal women
(-8.8 vs. -8.1). Menopause Rating Scale and Clinical Global
Impressions-Improvement Scale scores were significantly improved with
desvenlafaxine in postmenopausal women.
CONCLUSIONS: Desvenlafaxine 50 mg/day is effective in treating depression in both
perimenopausal and postmenopausal women. Placebo response on measures of
functional impairment is lower in perimenopausal women than in postmenopausal
women, resulting in a greater apparent treatment benefit with desvenlafaxine
among perimenopausal women.
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