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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.
Menopause. 2014 Aug; 21(8):799-806.M

Abstract

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.

Authors+Show Affiliations

From the 1Institute for Women's Health, Virginia Commonwealth University, Richmond, VA; 2University of Virginia, Charlottesville, VA; and 3Pfizer Inc, Collegeville, PA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24448103

Citation

Kornstein, Susan G., et al. "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." Menopause (New York, N.Y.), vol. 21, no. 8, 2014, pp. 799-806.
Kornstein SG, Clayton A, Bao W, et al. 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. Menopause. 2014;21(8):799-806.
Kornstein, S. G., Clayton, A., Bao, W., & Guico-Pabia, C. J. (2014). 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. Menopause (New York, N.Y.), 21(8), 799-806. https://doi.org/10.1097/GME.0000000000000178
Kornstein SG, et al. 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. Menopause. 2014;21(8):799-806. PubMed PMID: 24448103.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kornstein,Susan G, AU - Clayton,Anita, AU - Bao,Weihang, AU - Guico-Pabia,Christine J, PY - 2014/1/23/entrez PY - 2014/1/23/pubmed PY - 2015/4/17/medline SP - 799 EP - 806 JF - Menopause (New York, N.Y.) JO - Menopause VL - 21 IS - 8 N2 - 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. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/24448103/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_ L2 - http://dx.doi.org/10.1097/GME.0000000000000178 DB - PRIME DP - Unbound Medicine ER -