Menopause (New York, N.Y.) 08/2014; · 3.08 Impact Factor
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ABSTRACT: 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.
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.
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.
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.
Menopause (New York, N.Y.) 10/2013; · 3.08 Impact Factor
Clinical obstetrics and gynecology 09/2013; · 2.06 Impact Factor
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ABSTRACT: Osteoporosis is most prevalent in women over the age of 50 as the hormonal influence of estrogen on bone health dissipates with the onset of menopause. The progressive changes in bone structure, quality and density lead to pathological fractures and an increase in morbidity and mortality among menopausal women. This review will examine the 2010 North American Menopause Society (NAMS) position statement and other recent publications to summarize the data and combinations of therapies used to treat women 50 years or older with osteoporosis. To review the latest research and guidelines for osteoporosis management we performed a PubMed search using the parameters Linked to free full text, Humans, Female, Review, English, Middle Age (45-64 years and 45+ years), Age 65+ years, and published in the last five years. Articles were sorted by relevance and hand searching of these articles was done to further increase the yield. While a perfect treatment has yet to be discovered to completely cure this progressive disease, many breakthroughs have been made in order to prevent fractures and improve quality of life. Calcium and vitamin D supplementation are recommended for patients undergoing pharmacological treatment, however, trials looking at their effectiveness have mixed findings. Bisphosphonates are considered the first line therapy in the treatment of osteoporosis and reduce vertebral fractures by 40% to 70% and non-vertebral fractures by 20% to 35%. Calcitonin showed promise during early trials in 2000 with a 33% reduction in fractures but these results have not been replicated and this therapy is now relegated to a second line treatment. Teriparatide is recommended for patients with severe osteoporosis and has been shown to reduce vertebral fractures 65% and non-vertebral fractures 53%. Selective estrogen receptor modulators (SERMs) are another useful therapy resulting in a 55% reduction in vertebral fractures without any documented advantage when looking at non-vertebral fractures. The currently available SERMs for this indication include raloxifene, available in the USA, and bazedoxifene, in Europe. Estrogen is effective, with a 27% reduction in fractures, but often is reserved for concomitant use for other menopausal symptoms or in patients intolerant of other available osteoporosis therapies. The newly approved monoclonal antibody for osteoporosis treatment in postmenopausal women, denosumab, leads to a 68% and 19% reduction of vertebral and non-vertebral fractures, respectively. In conclusion, the 2010 NAMS position statement provides an excellent framework to discuss treatment options with patients. Lifestyle optimization should be the bedrock of any good treatment approach. When pharmacological intervention is warranted, many good therapies are available which have been shown to reduce the risk of fractures in osteoporotic patients. Any treatment plan, however, will be ineffective if the patient is not compliant. Therefore, a detailed discussion regarding each therapeutic intervention should ensue, including its usefulness and side effects.
Minerva ginecologica 06/2012; 64(3):181-94.
Minerva ginecologica 01/2012; 64(5):181-94.