Extended-release (ER) gabapentin (Serada, Depomed), an investigational nonhormonal medication, improves sleep and reduces hot flashes in menopausal women, according to a phase 3 clinical trial called BREEZE 3.

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The outcomes were presented here in the North American Menopause Society (NAMS) 23rd Annual Meeting.

“Today, if girls do not wish to take hormones, also if over-the-counter goods, acupuncture, and lifestyle modifications don’t work, we do not have some FDA [US Food and Drug Administration] approved remedies,” said lead researcher JoAnn Pinkerton, MD, who’s professor of obstetrics and gynecology in the University of Virginia at Charlottesville and beyond president of NAMS.

A New Drug Application was filed for gabapentin ER in July. If accepted, the medication is going to be the first nonhormonal, nonantidepressant remedy for the annoying symptoms of menopause, Dr. Pinkerton clarified.

BREEZE 3 appeared at the impact of gabapentin ER on hot flashes and on sleep. Statistics were presented in two unique abstracts by two unique investigators.

Gabapentin is used to control epileptic seizures and restless leg syndrome, and recently was accepted by the FDA for the treatment of postherpetic neuralgia.

The ER formula was designed to be taken two times a day rather than 3 times each day, which considerably reduces the adverse-effect profile, Dr. Pinkerton explained.

“Together with the short-acting edition, 20 percent of individuals have been somnolent or dizzy. In this trial, with all the extended-release formula, the speed of somnolence or nausea started at 11 percent and went to 3 percent speedily. It was quite well tolerated and not many people stopped treatment because of the symptoms,” she explained. In the end of 6 weeks, folks felt considerably better, ” she added.

Gabapentin Helps Hot Flashes

In BREEZE 3, 600 postmenopausal women (average age, 54.0 years; imply time since last menstrual period, 114 weeks; mean body mass indicator, 29.4 kg/m²) were randomized to get gabapentin 1800 mg per day (600 mg per day and 1200 mg in the day) or placebo. The potential double-blind randomized study was conducted in multiple facilities and lasted 24 weeks. Of those 600 women, 41 percent had surgically-induced menopause.

The frequency and severity of hot flashes have been measured at weeks 4 and 12 because the principal end point and also at week 24 because the secondary end point.

At this time, the average number of hot flashes was 11.8 daily at the gabapentin group and 12.0 daily in the placebo group. A total of 397 patients completed 24 months of therapy 206 (68.9 percent) from the gabapentin group and 191 (65.0 percent) from the placebo group.

The trial demonstrated that gabapentin significantly decreased the normal frequency of hot flashes at 4 months by 1.69 (95% confidence interval [CI], 2.29 into 1.08), in comparison with placebo (P < .0001), also from 1.14 (95% CI, 1.8 to 0.8) in 12 months (P = .0007).

Gabapentin also considerably decreased the average severity of hot flashes, compared with placebo, by 0.21 at 4 months (95% CI, 0.31 to 0.1; P < .0001) and by 0.19 in 12 months (95% CI, 0.33 to 0.04; P = .012).

These reductions were kept outside to 24 weeks.

Patients at the gabapentin group noted they were “considerably” or “very much” improved, compared with placebo, on the Patient Global Impression of Change scale in 12 months (68 percent versus 54%; P .0036) and at 24 months (74 percent versus 54%; P < .0001).

The medication was well tolerated, with just 5 percent more individuals in the gabapentin group compared to placebo group withdrawing because of adverse events (16.7% vs 11.5%), the investigators report. The most frequent adverse events from the gabapentin and placebo groups were dizziness (13% vs 3%), headache (9% versus 8 percent), somnolence (6% versus 3 percent), and upper respiratory tract infections (6% versus 4 percent).

Patients at the gabapentin group gained slightly more weight over 24 months compared to individuals in the placebo group (0.8 kg), but that wasn’t important.

Girls “need to have the ability to individualize their health care, speak above their options with suppliers, and choose the one which’s ideal for them…. This will be an additional choice they could make.”

Gabapentin Improves Insomnia

At the sleep component of BREEZE 3, gabapentin was discovered to have a positive effect on sleep disturbance. Researchers evaluated the effect of gabapentin using 2 steps of sleep: the Insomnia Severity Index (ISI) score along with the daily sleep disturbance (S/I) score.

At baseline, the mean ISI scores were 17.54 from the gabapentin group and 17.33 from the placebo group, suggesting moderate sleeplessness, and also the mean S/I scores were 7.3 and 7.4, respectively, indicating a moderate to severe sleep disturbance.

After 12 weeks, there was a clinically significant reduction in ISI score at the gabapentin group, in comparison with the placebo group (8.7 vs 6.3; P = .0044), also at S/I score (3.6 vs 2.8; P = .0056). Reductions out per week 24 were kept at the ISI score (8.6 vs 6.2; P = .0068) and at the S/I score (3.9 vs 3.0; P = .0084).

“I was glad that sleeping has been looked at in an objective manner. Should you ask many girls, their hot flushes at night actually irritate them. If they can not sleep because of hot flushes, they essentially cannot work during the day, thus we will need to check out sleep independently,” said Risa Kagan, MD, in East Bay Physicians Medical Group, Alta Bates Summit Medical Center, in Berkeley, and clinical professor at the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco, who headed the sleep component of BREEZE 3.

Dr. Kagan added that, despite the fact that it’s fine to check at each one the data, in the long run, the intention is to help women transition throughout the menopause. “This wasn’t only a placebo effect, this is really a statistically significant improvement in sleeping,” she clarified.

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