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A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB).

Authors :
Loprinzi CL
Dueck AC
Khoyratty BS
Barton DL
Jafar S
Rowland KM Jr
Atherton PJ
Marsa GW
Knutson WH
Bearden JD 3rd
Kottschade L
Fitch TR
Source :
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2009 Mar; Vol. 20 (3), pp. 542-9. Date of Electronic Publication: 2009 Jan 06.
Publication Year :
2009

Abstract

Introduction: Hot flashes represent a significant problem in men undergoing androgen deprivation therapy.<br />Materials and Methods: Via a prospective, double-blind, placebo-controlled clinical trial, men with hot flashes, on a stable androgen deprivation therapy program for prostate cancer, received a placebo or gabapentin at target doses of 300, 600, or 900 mg/day. Hot flash frequencies and severities were recorded daily during a baseline week and for 4 weeks while the patients took the study medication.<br />Results: In the 214 eligible patients who began the study drug on this trial, comparing the fourth treatment week to the baseline week, mean hot flash scores decreased in the placebo group by 4.1 units and in the three increasing dose gabapentin groups by, 3.2, 4.6, and 7.0 units. Comparing the three combined gabapentin arms to the placebo arm did not result in significant hot flash differences. Wilcoxon rank-sum P values for change in hot flash scores and frequencies after 4 weeks of treatment were 0.10 and 0.02, comparing the highest dose gabapentin arm to the placebo arm, respectively. The gabapentin was well tolerated in this trial.<br />Conclusion: These results support that gabapentin decreases hot flashes, to a moderate degree, in men with androgen ablation-related vasomotor dysfunction.

Details

Language :
English
ISSN :
1569-8041
Volume :
20
Issue :
3
Database :
MEDLINE
Journal :
Annals of oncology : official journal of the European Society for Medical Oncology
Publication Type :
Academic Journal
Accession number :
19129205
Full Text :
https://doi.org/10.1093/annonc/mdn644