PMID- 23010882 OWN - NLM STAT- MEDLINE DCOM- 20130531 LR - 20151119 IS - 1530-0374 (Electronic) IS - 1072-3714 (Linking) VI - 20 IP - 1 DP - 2013 Jan TI - Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. PG - 28-37 LID - 10.1097/gme.0b013e31826421a8 [doi] AB - OBJECTIVE: The aim of this study was to assess the 12-week efficacy of desvenlafaxine in treating moderate to severe vasomotor symptoms and the clinical relevance of improvements in postmenopausal women experiencing 50 or more moderate to severe hot flashes per week. METHODS: Participants were randomized to placebo or desvenlafaxine 100 mg/day in the 12-week efficacy substudy of a year-long, multicenter, parallel-group, double-blind study. Coprimary outcomes were changes from baseline in the daily number and severity of hot flashes on weeks 4 and 12. The percentage of women achieving the minimal clinically important difference (MCID) in the number of hot flashes on week 12 was determined. RESULTS: The efficacy substudy modified intent-to-treat population included 365 women (desvenlafaxine, n = 184; placebo, n = 181). Desvenlafaxine 100 mg/day significantly reduced the number and severity of hot flashes versus placebo on week 4 (P < 0.001) and week 12 (P < 0.001). On week 12, desvenlafaxine reduced the number of moderate and severe hot flashes by 7.3 (62%) per day (placebo, -4.5 [38%] per day) and the severity score by 0.59 (25%) per day (placebo, -0.28 [12%] per day). MCID-a reduction of 5.35 moderate and severe hot flashes per day-was achieved by 64% of desvenlafaxine-treated women (placebo, 41%; P < 0.001). In all, 17.2% (67/390) of participants discontinued, 10.0% (20/200) of participants taking desvenlafaxine and 3.7% (7/190) of participants taking placebo discontinued because of adverse events (P = 0.016), and 2.5% (5/200) of participants taking desvenlafaxine and 8.4% (16/190) of participants taking placebo discontinued because of lack of efficacy (P = 0.012). CONCLUSIONS: Postmenopausal women with moderate to severe hot flashes who are treated with desvenlafaxine achieve rapid symptom reduction that is clinically relevant based on MCID. FAU - Pinkerton, JoAnn V AU - Pinkerton JV AD - University of Virginia Health System, Charlottesville, VA 22903, USA. JVP9U@Virginia.edu FAU - Constantine, Ginger AU - Constantine G FAU - Hwang, Eunhee AU - Hwang E FAU - Cheng, Ru-Fong J AU - Cheng RF CN - Study 3353 Investigators LA - eng SI - ClinicalTrials.gov/NCT00683800 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Menopause JT - Menopause (New York, N.Y.) JID - 9433353 RN - 0 (Antidepressive Agents) RN - 0 (Cyclohexanols) RN - 0 (Placebos) RN - ZB22ENF0XR (Desvenlafaxine Succinate) SB - IM MH - Aged MH - Antidepressive Agents/*therapeutic use MH - Cyclohexanols/adverse effects/*therapeutic use MH - Desvenlafaxine Succinate MH - Double-Blind Method MH - Female MH - Hot Flashes/*drug therapy MH - Humans MH - Menopause/*physiology MH - Middle Aged MH - Placebos MH - Postmenopause/physiology MH - Treatment Outcome FIR - Moe, P Ryan IR - Moe PR FIR - Obritsch, Jerry IR - Obritsch J FIR - Parker, Robert Lamar Jr IR - Parker RL Jr FIR - Poindexter, Alfred IR - Poindexter A FIR - Raman, Anuradha IR - Raman A FIR - Reagan, Rovena IR - Reagan R FIR - Rowe, Daniel IR - Rowe D FIR - Phillips, Robert IR - Phillips R FIR - Sapin, Neil J IR - Sapin NJ FIR - Scutella, Michael IR - Scutella M FIR - Seidman, Larry S IR - Seidman LS FIR - Swanson, Stephen G IR - Swanson SG FIR - Valaoras, Thomas G IR - Valaoras TG FIR - Delahunty, Nigel Patrick IR - Delahunty NP FIR - Donovan, Arthur IR - Donovan A FIR - Edger, Donald E IR - Edger DE FIR - Fenton, Douglas IR - Fenton D FIR - Floyd, Susan IR - Floyd S FIR - Fowler, Stephanie IR - Fowler S FIR - Gaetze, Jane O IR - Gaetze JO FIR - Gass, Margery IR - Gass M FIR - Gearhart, David L IR - Gearhart DL FIR - Gorman, Ann IR - Gorman A FIR - Hermann, Scotty R IR - Hermann SR FIR - Vendeland, Lisa L IR - Vendeland LL FIR - Waldbaum, Arthur IR - Waldbaum A FIR - Whittington, F Kim IR - Whittington FK FIR - Williams, Stan IR - Williams S FIR - Yankaskas, Mary IR - Yankaskas M FIR - Aguirre, Oscar A IR - Aguirre OA FIR - Baker, Jeffrey IR - Baker J FIR - Ballard, Jeanne IR - Ballard J FIR - Bearnson, Patricia IR - Bearnson P FIR - Berg, Saul IR - Berg S FIR - Berger, Murray IR - Berger M FIR - Beyerlein, Richard IR - Beyerlein R FIR - Brandenburg, Verdayne IR - Brandenburg V FIR - Bretton, Elizabeth IR - Bretton E FIR - Brody, Kirk IR - Brody K FIR - Hoggarth, Tonia IR - Hoggarth T FIR - Holm, Mary K IR - Holm MK FIR - Huffman, Cynthia IR - Huffman C FIR - Jennings, William IR - Jennings W FIR - Kalafer, Marvin IR - Kalafer M FIR - Knapp, Howard IR - Knapp H FIR - Koltun, William D IR - Koltun WD FIR - Kroll, Robin IR - Kroll R FIR - Lackey, James D IR - Lackey JD FIR - Lubin, Barry IR - Lubin B FIR - Lunde, Norman Martin IR - Lunde NM FIR - Dietrich, Janet IR - Dietrich J FIR - Drosman, Steven IR - Drosman S FIR - Farmer, Mildred IR - Farmer M FIR - Feldman, Robert IR - Feldman R FIR - Finnegan, Patrick IR - Finnegan P FIR - Gerrish, Catherine IR - Gerrish C FIR - Gollapudi, G Murthy IR - Gollapudi GM FIR - Hoekstra, John Arthur IR - Hoekstra JA FIR - Lederman, Samuel IR - Lederman S FIR - Manganiello, Paul D IR - Manganiello PD FIR - Pack, Edmond IR - Pack E FIR - Pinkerton, JoAnn Vensko IR - Pinkerton JV FIR - Walland, Debra IR - Walland D FIR - Semple, Lisa IR - Semple L FIR - Shields, Ruth Lyons IR - Shields RL FIR - Smith, Robert L Jr IR - Smith RL Jr FIR - Spitz, Robert M IR - Spitz RM FIR - Tomlinson, Daniel A IR - Tomlinson DA FIR - Baron, Mira IR - Baron M FIR - Fried, David L IR - Fried DL FIR - Goldberg, Cynthia IR - Goldberg C FIR - Nedoss, Bertrand R IR - Nedoss BR FIR - Sigman, Gerald IR - Sigman G FIR - Stavoy, Thomas G IR - Stavoy TG FIR - Weinstein, Richard L IR - Weinstein RL FIR - Zbella, Edward A IR - Zbella EA FIR - Archer, David F IR - Archer DF FIR - Barker, Charles L IR - Barker CL FIR - Rothman, Jack IR - Rothman J FIR - Feltheim, Carol J IR - Feltheim CJ FIR - Gee, Phyllis J IR - Gee PJ FIR - Ho, Lester IR - Ho L FIR - Hrozencik, Donna S IR - Hrozencik DS FIR - McCluskey, Dennis C IR - McCluskey DC FIR - Bressman, Phillip L IR - Bressman PL FIR - Watkins, Julia M IR - Watkins JM FIR - Tanner, James Arden IR - Tanner JA FIR - Summers, William D IR - Summers WD FIR - Weprin, Stuart IR - Weprin S FIR - Woodson, Grattan C IR - Woodson GC FIR - Spratt, Daniel I IR - Spratt DI FIR - Moyer, Gayle S IR - Moyer GS FIR - Casson, Peter IR - Casson P FIR - Funk, Sidney A IR - Funk SA FIR - Williams, Brenda M IR - Williams BM FIR - Scott, Shali Ricker IR - Scott SR FIR - Twede, Michael L IR - Twede ML FIR - Ramsay, Andrea J IR - Ramsay AJ FIR - Speller, Marsha IR - Speller M FIR - Taber, Louise A IR - Taber LA FIR - Biunno, Michael J IR - Biunno MJ FIR - Fisk, Frances M IR - Fisk FM FIR - May, Caroline V IR - May CV FIR - Smith, William B IR - Smith WB FIR - Lowe, Derek IR - Lowe D FIR - Frenette, Louise IR - Frenette L FIR - Gorfinkel, Iris S IR - Gorfinkel IS FIR - Lasko, Benjamin H IR - Lasko BH FIR - Sethna, Rustom H IR - Sethna RH FIR - Tellier, Guy IR - Tellier G FIR - Blouin, Francois IR - Blouin F FIR - Ayotte, Normand J IR - Ayotte NJ FIR - Hauck, Brian A IR - Hauck BA FIR - Boroditsky, Richard S IR - Boroditsky RS FIR - O'Mahony, William F IR - O'Mahony WF FIR - Fortier, Michel IR - Fortier M FIR - Janzen, Jeannette L IR - Janzen JL FIR - Beauchesne, Andre IR - Beauchesne A FIR - Carlson, Brian IR - Carlson B FIR - Derzko, Christine M IR - Derzko CM FIR - O'Mahony, Michael F J IR - O'Mahony MF FIR - Gamache, Nathalie IR - Gamache N FIR - Bergeron, Richard IR - Bergeron R FIR - Ayers, Charletta A IR - Ayers CA FIR - Brainard, C Paige IR - Brainard CP FIR - Booth, William IR - Booth W FIR - Ramjattan, Brian R IR - Ramjattan BR FIR - Lobo, Rogerio A IR - Lobo RA EDAT- 2012/09/27 06:00 MHDA- 2013/06/01 06:00 CRDT- 2012/09/27 06:00 PHST- 2012/09/27 06:00 [entrez] PHST- 2012/09/27 06:00 [pubmed] PHST- 2013/06/01 06:00 [medline] AID - 10.1097/gme.0b013e31826421a8 [doi] PST - ppublish SO - Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.