title: Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause.
abstract: OBJECTIVE
  The goal of this study was to evaluate the efficacy and safety of gastroretentive gabapentin (G-GR) for the treatment of moderate-to-severe menopausal hot flashes.
  
  
  METHODS
  The primary endpoints of this randomized, placebo-controlled study of G-GR (600 mg am/1,200 mg pm) were the mean daily frequency and severity of hot flashes at weeks 4 and 12. Secondary endpoints included Patients' Global Impression of Change, Clinicians' Global Impression of Change, and daily sleep interference at week 24.
  
  
  RESULTS
  Six hundred women with 7 or more moderate-to-severe hot flashes/day enrolled; 66.2% completed 24 weeks of treatment. At weeks 4 and 12, G-GR-treated women experienced significantly greater reductions in mean hot flash frequency and severity than placebo-treated women (frequency: week 4, -1.7, P < 0.0001; week 12, -1.14, P = 0.0007; severity: week 4, -0.21, P < 0.0001; week 12, -0.19, P = 0.012). Similar reductions were maintained up to week 24. On the Patient Global Impression of Change, more women receiving G-GR than placebo were "much" or "very much" improved (week 12: 58% vs 44%, P = 0.0008; week 24: 76% vs 55%, P < 0.0001). G-GR significantly reduced sleep interference compared with placebo at week 12 (P = 0.0056) and week 24 (P = 0.0084). Approximately 5% more women taking G-GR withdrew because of adverse events (G-GR/placebo, 16.7%/11.5%). The most common adverse events were dizziness (12.7%/3.4%), headache (9.3%/8.1%), and somnolence (6.0%/2.7%); incidences dropped to sustained low levels after a few weeks.
  
  
  CONCLUSIONS
  G-GR is a modestly effective nonhormone therapy option for the treatment of moderate-to-severe hot flashes due to menopause and is well tolerated with titration.
authors.affiliation: From the 1Division of Midlife, Department of Obstetrics and Gynecology, University of Virginia Health Sciences Center, Charlottesville, VA; 2East Bay Physicians Medical Group, Sutter East Bay Medical Foundation, Berkeley, CA; 3Columbus Center for Women's Health Research, Columbus, OH; and 4Depomed Inc, Newark, CA.
authors.forename: JoAnn V
authors.initials: JV
authors.lastname: Pinkerton
authors.forename: Risa
authors.initials: R
authors.lastname: Kagan
authors.forename: David
authors.initials: D
authors.lastname: Portman
authors.forename: Rekha
authors.initials: R
authors.lastname: Sathyanarayana
authors.forename: Michael
authors.initials: M
authors.lastname: Sweeney
mesh_terms: D000328:Adult; D000368:Aged; D000588:Amines / Q000009:adverse effects / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D000077206:Gabapentin; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000588:Amines; D002121:Calcium Channel Blockers; D003509:Cyclohexanecarboxylic Acids; D003692:Delayed-Action Preparations; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin