Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause

Abstract

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.

EMAS position statement: Non-hormonal management of menopausal vasomotor symptoms

“…They showed significant reductions in hot flush frequency and severity in women treated with gastroretentive gabapentin. However 5% more women taking gabapentin withdrew because of adverse events, compared to those receiving placebo [33].…”

Randomized Controlled Trial versus Real-World Study in Postherpetic Neuralgia

“…Thus, it is important to note that, in a number of different studies, all AEs associated with G-GR decreased rapidly and reached low levels after the 2-week titration period. This has been shown in the RCTs and the real-world study for the treatment of PHN [23,36], as well as in the RCTs for the treatment of hot flashes in post-menopausal women [37]. Thus, as long as patients are aware of the tolerability profile and much lower incidence of AEs after titration, they may be able to manage the titration better and be more successful in reaching therapeutically effective dosages of G-GR.…”

Sleep disturbances in menopausal women: Aetiology and practical aspects

“…Gabapentin has also shown efficacy on HF [13]. Recently, a positive effect of this drug was demonstrated on 'LUNA' [14], a syndrome associating low oestradiol levels and night-time awakening, with or without HF.…”