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Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause.

Author(s): Archer DF(1), Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators.

Collaborators: Moe P, Obritsch J, Parker RL Jr, Poindexter A, Raman A, Reagan R, Rowe D, Phillips R, Sapin NJ, Scutella M, Seidman LS, Swanson SG, Valaoras TG, Delahunty NP, Donovan A, Edger DE, Fenton D, Floyd S, Fowler S, Gaetze JO, Gass M, Gearhart DL, Gorman A, Hermann SR, Vendeland LL, Waldbaum A, Whittington F, Williams S, Yankaskas M, Aguirre OA, Baker J, Ballard J, Bearnson P, Berg S, Berger M, Beyerlein R, Brandenburg V, Bretton E, Brody K, Hoggarth T, Holm MK, Huffman C, Jennings W, Kalafer M, Knapp H, Koltun WD, Kroll R, Lackey JD, Lubin B, Lunde NM, Dietrich J, Drosman S, Farmer M, Feldman R, Finnegan P, Gerrish C, Gollapudi G, Hoekstra JA, Lederman S, Manganiello PD, Pack E, Pinkerton JV, Walland D, Semple L, Shields RL, Smith RL Jr, Spitz RM, Tomlinson DA, Baron M, Fried DL, Goldberg C, Nedoss BR, Sigman G, Stavoy TG, Weinstein RL, Zbella EA, Archer DF, Barker CL, Rothman J, Feltheim CJ, Gee PJ, Ho L, Hrozencik DS, McCluskey DC, Bressman PL, Watkins JM, Tanner JA, Summers WD, Weprin S, Woodson GC, Spratt DI, Moyer GS, Casson P, Funk SA, Williams BM, Scott SR, Twede ML, Ramsay AJ, Speller M, Taber LA, Biunno MJ, Fisk FM, May CV, Smith WB, Lowe D, Frenette L, Garfinkel IS, Lasko BH, Sethna RH, Tellier G, Blouin F, Ayotte NJ, Hauck BA, Boroditsky RS, O'Mahony WF, Fortier M, Janzen JL, Beauchesne A, Carlson B, Derzko CM, O'Mahony MF, Gamache N, Bergeron R, Ayers CA, Brainard C, Booth W, Ramjattan BR, Lobo RA.

Affiliation(s): Author information: (1)Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA 23507, USA. archerdf@evms.edu

Publication date & source: 2013, Menopause. , 20(1):47-56

OBJECTIVE: A previous trial of the serotonin-norepinephrine reuptake inhibitor desvenlafaxine (administered as desvenlafaxine succinate) raised concerns on potential serious cardiovascular and hepatic events. The current study was designed to estimate these events in desvenlafaxine versus placebo in a larger population followed for 1 year. METHODS: Healthy postmenopausal women seeking treatment of vasomotor symptoms were randomized to placebo or desvenlafaxine 100 mg/day in a 1-year, multicenter, double-blind study. Safety was monitored throughout. Potential ischemic cardiovascular events (coronary heart disease-related death, new-onset myocardial infarction or unstable angina requiring hospitalization, and unscheduled revascularization procedures) and cerebrovascular events (definite stroke or probable stroke) identified by investigator reports and periodic adverse event review based on Standardized medical dictionary for regulatory activities Query were reviewed by blinded adjudication boards. Hepatic events (aspartate aminotransferase or alanine aminotransferase >5 times the upper limit of normal) were evaluated. RESULTS: A total of 2,118 participants (1,066 desvenlafaxine, 1,052 placebo) took one or more doses of study medication (mean, 280 d). There was one cardiovascular event; a placebo-treated participant was adjudicated to have had a myocardial infarction. One desvenlafaxine-treated participant was adjudicated to have had a probable stroke. Two participants in each treatment group had hepatic events. The excess risk (90% CI) of desvenlafaxine over placebo per 1,000 woman-years was -1.07 (-2.86 to 0.72) for cardiovascular events, 1.11 (-0.68 to 2.9) for cerebrovascular events, and 0.08 (-3.51 to 3.67) for hepatic events. CONCLUSIONS: There is no evidence for an increased risk of cardiovascular, cerebrovascular, or hepatic events associated with desvenlafaxine 100 mg/day compared with placebo for the treatment of menopausal vasomotor symptoms.

Page last updated: 2014-12-01

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