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    Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    Gabapentin Improves Menopausal Hot Flashes, Insomnia
    by Fran Lowry, Medscape
    Oct 08, 2012

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

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

    "Right now, if women don't want to take hormones, and if over-the-counter products, acupuncture, and lifestyle changes do not work, we don't have any FDA [US Food and Drug Administration] approved therapies," said lead researcher JoAnn Pinkerton, MD, who is professor of obstetrics and gynecology at the University of Virginia in Charlottesville and past president of NAMS.

    A New Drug Application was submitted for gabapentin ER in July. If approved, the drug will be the first nonhormonal, nonantidepressant treatment for the bothersome symptoms of menopause, Dr. Pinkerton explained.

    BREEZE 3 looked at the effect of gabapentin ER on hot flashes and on sleep. Data were presented in 2 different abstracts by 2 different investigators.

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

    The ER formulation was developed to be taken twice a day instead of 3 times a day, which significantly decreases the adverse-effect profile, Dr. Pinkerton said.

    "With the short-acting version, 20% of patients were somnolent or dizzy. In this trial, with the extended-release formulation, the rate of somnolence or dizziness started at 11% and went down to 3% very quickly. It was very well tolerated and very few people discontinued treatment because of those symptoms," she said. At the end of 6 months, people felt significantly better, she added.

    Gabapentin Helps Hot Flashes
    In BREEZE 3, 600 postmenopausal women (mean age, 54.0 years; mean time since last menstrual period, 114 months; mean body mass index, 29.4 kg/m?) were randomized to receive gabapentin 1800 mg daily (600 mg in the morning and 1200 mg in the evening) or placebo. The prospective double-blind randomized study was conducted at multiple centers and lasted 24 weeks. Of the 600 women, 41% had surgically-induced menopause.

    The frequency and severity of hot flashes were measured at weeks 4 and 12 as the primary end point and at week 24 as the secondary end point.

    At baseline, the mean number of hot flashes was 11.8 per day in the gabapentin group and 12.0 per day in the placebo group. A total of 397 patients completed 24 weeks of treatment — 206 (68.9%) in the gabapentin group and 191 (65.0%) in the placebo group.

    The trial showed that gabapentin significantly reduced the average frequency of hot flashes at 4 weeks by 1.69 (95% confidence interval [CI], 2.29 to 1.08), compared with placebo (P < .0001), and by 1.14 (95% CI, 1.8 to 0.8) at 12 weeks (P = .0007).

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

    These reductions were maintained out to 24 weeks.

    Patients in the gabapentin group reported that they were "much" or "very much" improved, compared with placebo, on the Patient Global Impression of Change scale at 12 weeks (68% vs 54%; P = .0036) and at 24 weeks (74% vs 54%; P < .0001).

    The drug was well tolerated, with only 5% more patients in the gabapentin group than in the placebo group withdrawing because of adverse events (16.7% vs 11.5%), the researchers report. The most common adverse events in the gabapentin and placebo groups were dizziness (13% vs 3%), headache (9% vs 8%), somnolence (6% vs 3%), and upper respiratory tract infections (6% vs 4%).

    Patients in the gabapentin group gained slightly more weight over 24 weeks than those in the placebo group (0.8 kg), but this was not significant.

    Women "need to be able to individualize their healthcare, talk over their choices with providers, and select the one that's right for them.... This will be another choice they can make."

    Gabapentin Improves Insomnia
    In the sleep part of BREEZE 3, gabapentin was found to have a positive impact on sleep disturbance. Researchers assessed the impact of gabapentin using 2 measures of sleep: the Insomnia Severity Index (ISI) score and the daily sleep interference (S/I) score.

    At baseline, the mean ISI scores were 17.54 in the gabapentin group and 17.33 in the placebo group, indicating moderate insomnia, and 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 meaningful reduction in ISI score in the gabapentin group, compared with the placebo group (8.7 vs 6.3; P = .0044), and in S/I score (3.6 vs 2.8; P = .0056). Reductions out to week 24 were maintained in the ISI score (8.6 vs 6.2; P = .0068) and in the S/I score (3.9 vs 3.0; P = .0084).

    "I was happy that sleep was looked at in an objective way. If you ask many women, their hot flushes at night really bother them. If they can't sleep because of hot flushes, they basically cannot function during the day, so we need to look at sleep separately," said Risa Kagan, MD, from East Bay Physicians Medical Group, Alta Bates Summit Medical Center, in Berkeley, and clinical professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco, who led the sleep part of BREEZE 3.

    Dr. Kagan added that, although it is fine to look at all of the data objectively, in the end, the aim is to help women transition through the menopause. "This was not just a placebo effect, this was actually a statistically significant improvement in sleep over placebo," she explained.

    Nonhormonal Options Welcome
    Vanessa M. Barnabei, MD, PhD, the Patrick and Margaret McMahon Endowed Professor of Gynecology and Obstetrics and director of general obstetrics and gynecology at the Medical College of Wisconsin in Milwaukee, and chair of the Department of Gynecology and Obstetrics at the University at Buffalo School of Medicine and Biomedical Sciences in New York, agrees that nonhormonal alternatives to treat hot flashes and sleep disturbances are welcome.

    "Patients and providers are always looking for nonhormonal options to treat these symptoms. Gabapentin has been an alternative, but side effects have limited its use. Extended-release gabapentin appears to offer a viable option, particularly for improving the severity of hot flashes and sleep quality," Dr. Barnabei told Medscape Medical News.

    "Discussion of potential side effects prior to use is very important, but this drug appears to be a safe alternative to hormones," she said.

    BREEZE 3 was sponsored by Depomed. Dr. Pinkerton reports financial relationships with Depomed, Merck, Novogyne, Pfizer, Shionogi, Bionova, Bionovo, and Endoceutics. Dr. Kagan reports financial relationships with Bionovo, BioSante Pharmaceuticals, Merck, Noven, Novo Nordisk, Novogyne, Pfizer, and Shionogi. Dr. Barnabei reports no relevant financial relationships.

    Source: North American Menopause Society (NAMS) 23rd Annual Meeting. Abstract S-8, presented October 5; Abstract S-20, presented October 6, 2012.

  2. #2
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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    It looks as though there is a double post in the article.

    I had recently tried this becasue my previous family doctor wanted to take me off HRT which I had only been on for 3 yrs. I thought is was going to work great but at week 6 my severe hot flashes came back with a vengeance (even though I was still slowly reducing my HRT) and the doctor at the time said it was best to just go back on HRT instead of playing with doses etc.

    My fear was that I would require a higher dose of HRT (I'm on the lowest dose) or that it would not work at all....It was stressful and difficult to wait for the HRT to start working again - but it did.

    I had also tried Clonidine before HRT and it was effective for the first year then my hot flashes became severe and because I have low blood pressure (naturally) increasing the dose was not an option.

    I am really happy with my HRT and my recent doctor said it was fine to just continue with it. I have said in the past that I would rather have a shorter life ( if that is the tradeoff ) and have quality of life while I am living because for me the symptoms have been nothing but disabling.

    I also had to have minor surgery to control heavy bleeding which can also be another symptom of peri-menopause. This also then causes iron deficiency.

    Honestly, I was very angry that I had to go through all of this because most literature talks about hot flashes and other symptoms as if they are minor at worst. When people laugh or make references to peri-menaopause or menopause as though it is a natural and easy process for women to go through (or does not exist).....I want to hit them

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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    I upsets me enormously that society in general as soon as woman is done with childbearing they are over looked in everything.

    There needs to be a change in mentality about this point in a woman's life because I would hate for me to have had my daughter and her put up with being palmed off the way I am starting to now I am in my 40's.

    You suddenly become a statistic as soon as you turn 40 rather than anything else.

    I have reservations about Gabapentin being touted as a wonder drug, as it has adverse effects on memory and a few other side effects but anything that highlights a point in a woman's life that no one really wants to know about (and gets people talking) is better than nothing!

    *preparing for hormone battle*

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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    Wooby, I hope it is an easy process for you. Most women I know did not have the experiences I had.

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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    I had a great conversation with a lady at work the other day and we compared perimenopause symptoms. What an eye-opener!
    I need to have a conversation with my GP about options. She put me on birthcontrol to help deal with heavy bleeding, but I felt my mood taking a dip so we decided to take me off that.
    I've heard about the surgery to help with heavy bleeding - and will talk with my doctor to see if that might be right for me. I've had to miss a few days of work because of it.
    How do you explain have to run to the bathroom every hour - it's really gross and awful.
    Will also have to think about hrt for the future as well, depending on symptoms.
    So glad for these threads.

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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    I had endometrial ablation surgery 8 years ago. In my case the results were spectacular. Post operative pain was minimal; menstrual cramping was eliminated and panty liners were all that were required post surgery.
    Change begins when you practice ordinary courage

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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    Ablation - right that's what it's called. The lady at work had that, but it didn't take the first time and she is scheduled for another soon.
    And yes she said it was and easy procedure.

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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    I was going to have an ablation before my hysterectomy but my surgeon didn't want to bother because it doesn't always take, especially in young women. I went straight for the hysterectomy but left ovaries so I'm going to go through menopause at some point. It honestly scares me.

    gardens - my friend had it done when she was just a bit younger than you and had wonderful results. Definitely check if its a viable option for you. There is no need to suffer.

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    Re: Gabapentin Improves Menopausal Hot Flashes and Insomnia in Menopausal Women

    RDW, I had an ablation too and it was so wonderful to have immediate relief from the heavy bleeding. I did not even have one cramp following that surgery. it was great!

    Gardens, I was like you and could not attend work for a few days because it was so heavy that there wasn't anything on the market to get me through an hour! I was worried I was going to bleed out. A couple of months before the ablation I had only one week of the month without bleeding! Not as heavy as the few days though.

    Turtle, my OBGYN said that before ablations the only option for women in my circumstance was to have a hysterectomy which as you know is major surgery and requires a long recovery. Glad you are well! Don't worry about menopause. You could very well have few or minor symptoms. Ask your mother what it was like for her and although it may not be exactly like her experience you can at least prepare for the possibility of something similar.

    Oh the joys of a uterus....

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