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Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause.
Menopause. 2014 Jun; 21(6):567-73.M

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+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24149930

Citation

Pinkerton, JoAnn V., et al. "Phase 3 Randomized Controlled Study of Gastroretentive Gabapentin for the Treatment of Moderate-to-severe Hot Flashes in Menopause." Menopause (New York, N.Y.), vol. 21, no. 6, 2014, pp. 567-73.
Pinkerton JV, Kagan R, Portman D, et al. Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause. 2014;21(6):567-73.
Pinkerton, J. V., Kagan, R., Portman, D., Sathyanarayana, R., & Sweeney, M. (2014). Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause (New York, N.Y.), 21(6), 567-73. https://doi.org/10.1097/GME.0b013e3182a7c073
Pinkerton JV, et al. Phase 3 Randomized Controlled Study of Gastroretentive Gabapentin for the Treatment of Moderate-to-severe Hot Flashes in Menopause. Menopause. 2014;21(6):567-73. PubMed PMID: 24149930.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. AU - Pinkerton,JoAnn V, AU - Kagan,Risa, AU - Portman,David, AU - Sathyanarayana,Rekha, AU - Sweeney,Michael, AU - ,, PY - 2013/10/24/entrez PY - 2013/10/24/pubmed PY - 2015/2/20/medline SP - 567 EP - 73 JF - Menopause (New York, N.Y.) JO - Menopause VL - 21 IS - 6 N2 - 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. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/24149930/Phase_3_randomized_controlled_study_of_gastroretentive_gabapentin_for_the_treatment_of_moderate_to_severe_hot_flashes_in_menopause_ L2 - https://doi.org/10.1097/GME.0b013e3182a7c073 DB - PRIME DP - Unbound Medicine ER -