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Objectives: To determine whether assessment of all moderate-to-severe symptoms at baseline gives a more accurate evaluation of the treatment effect of ospemifene in vulvovaginal atrophy (VVA) than the most bothersome symptom (MBS) approach.Methods: Data were pooled from two pivotal phase-III clinical trials evaluating the efficacy and safety of oral ospemifene 60 mg/day for the treatment of symptoms of VVA (n = 1463 subjects). Symptoms of vaginal dryness, dyspareunia, and vaginal and/or vulvar irritation/itching reported as moderate or severe at baseline were evaluated. Clinically relevant differences between ospemifene and placebo were analyzed using a four-point severity scoring system and presented as improvement, substantial improvement, or relief.Results: Subjects in these studies reported statistically significant improvement, substantial improvement, and relief for vaginal dryness (p < 0.00001), dyspareunia (p < 0.001) and statistically significant improvement and relief for vaginal and/or vulvar irritation/itching (p < 0.01) from baseline to week 12 with ospemifene compared with placebo. A similar trend was observed for women who reported substantial improvement of vaginal and/or vulvar irritation/itching.Conclusions: For drug registration purposes, the use of the MBS model is appealing because of its simplicity and ease of scientific validation. However, the MBS model may underestimate the total magnitude of the clinical benefit of ospemifene treatment for symptomatic women suffering from VVA. [ABSTRACT FROM AUTHOR]

Objectives To explore clinically relevant differences in severity of vulvar and vaginal atrophy (WA) in postmenopausal women treated with ospemifene compared with placebo. Methods Analysis of two multi-center, randomized, double-blind, 12-week phase-III studies in postmenopausal women (40-80 years, with WA, treated with ospemifene 60 mg/day or placebo (Study 310 and Study 821)). Severity of vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clinically relevant differences between ospemifene and placebo were analyzed and are presented as improvement (reduction in > 1 unit on four-point scoring system), substantial improvement (reduction in 2-3 units on four-point scoring system) and relief (severity score of mild/none after 12 weeks). Results In Study 310, significantly more women with a most bothersome symptom of dyspareunia had improvement (68.3% vs. 54.1%; p = 0.0255) or relief (57.5% vs. 41.8%; p = 0.0205) in the severity of dyspareunia from baseline to week 12 with ospemifene compared with placebo. For those with a most bothersome symptom of vaginal dryness, significantly more experienced improvement (74.6% vs. 57.7%; p = 0.0101), substantial improvement (42.4% vs. 26.9%; p = 0.0172) and relief (66.1% vs. 49.0%; p = 0.0140) of vaginal dryness from baseline to week 12 with ospemifene compared with placebo. Proportions of women with improvement/substantial improvement/relief of symptoms of vaginal dryness or dyspareunia were similar in Study 821. Clinically relevant differences were noticeable by week 4. Conclusions Treatment with ospemifene was consistently associated with greater improvement, substantial improvement or relief in the severity of the most bothersome symptoms of vaginal dryness or dyspareunia compared with placebo. [ABSTRACT FROM AUTHOR]

El artículo discute recomendaciones de la Sociedad Internacional de Menopausia (IMS por sus siglas en inglés) sobre el uso de terapia hormonal para el tratamiento de la menopausia, con énfasis en información actualizada en el año 2013. Algunos temas discutidos incluyen el uso de estrógenos y progestágenos, prevención y tratamiento de fracturas debido a osteoporosis posmenopáusica y prevención de enfermedades cardiovasculares.

The article focuses on the 2013 International Menopause Society (IMS) recommendations on menopausal hormone therapy (MHT) and the strategies to maintain the health of middle-age women. Topics discussed include the lifestyle recommendations for peri- and postmenopausal women, the importance of MHT, and the prevention of postmenopausal osteoporosis.

The Women's Health Initiative (WHI) randomized, controlled trial was the first study to prove that hormone replacement therapy (HRT) reduces the incidence of all osteoporosis-related fractures in postmenopausal women, even those at low risk of fracture. The study authors concluded that the bone-friendly aspect of HRT was limited in clinical practice as possible adverse effects outweighed possible benefit. On the strength of these publications, regulatory authorities downgraded the use of HRT for the prevention of fracture to second-line therapy. This article examines the original and subsequent evidence presented by the WHI study and concludes that the restrictions placed on HRT as a bone-specific drug by regulatory bodies have not withstood the test of time and are not supported by the data of the WHI. [ABSTRACT FROM AUTHOR]

Objective To evaluate the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) vs. tibolone and placebo for menopausal vasomotor symptoms and the incidence of uterine bleeding. Methods This 12-week, double-blind, randomized, controlled trial was conducted at 35 sites in Europe, two sites in South Africa, and one site in Mexico. Postmenopausal women with ≥50 moderate or severe hot flushes per week ( n == 485) were randomized to desvenlafaxine 100 mg/day, tibolone 2.5 mg/day, or placebo. Reduction in the average daily number of moderate and severe hot flushes at weeks 4 and 12 (primary endpoint) was evaluated using analysis of covariance. Safety assessments included incidence of uterine bleeding, adverse events, laboratory values, and vital signs. Results At week 12, no statistically significant difference was observed in reduction of the average daily number of moderate and severe hot flushes for desvenlafaxine (−5.78) vs. placebo (−5.82; p == 0.921), although time to 50% reduction was significantly less than placebo (13 vs. 26 days, p == 0.006). Hot flush reduction with tibolone (−8.21) was significantly greater than placebo ( p < 0.001). Nausea was the most common adverse event with desvenlafaxine, was generally mild to moderate, and resolved within the first 2 weeks. Significantly more subjects experienced bleeding with tibolone (23%) vs. desvenlafaxine (12%; p < 0.024) or placebo (9%; p < 0.001). Conclusions Desvenlafaxine did not separate from placebo in reducing the number of moderate to severe hot flushes at week 12, although it did allow women to achieve 50% reduction sooner than placebo. Tibolone did separate from placebo, but with smaller than expected effect. The placebo effect was high (57%). Adverse drug reactions were consistent with the known safety profile of desvenlafaxine, and significantly more women who received tibolone experienced episodes of bleeding compared with women who received desvenlafaxine or placebo. [ABSTRACT FROM AUTHOR]

The article discusses choices in the prevention and treatment of osteoporosis among postmenopausal women. It suggests that all postmenopausal women should embrace bone friendly life-style changes and exercise to prevent osteoporosis related fractures. It proposes that bone toxic substances such as alcohol abuse and cigarette smoking should be avoided, and glucocorticoid use should be restricted to the smallest effective dose. It recommends balanced diet and protein supplementation to maintain the protein matrix of bone.

Background: Treatment advances have reduced the adverse events associated with hematopoietic stem cell transplant (HSCT) and led to an increased number of transplants performed. HSCT patients are living longer with concerns on long-term outcomes. Bone fragility and fracture are at the forefront for long-term morbidities post-HSCT., Results: In HSCT recipients, evidence has accumulated to support recommendations for more extensive monitoring of bone fragility and more appropriate administration of osteoporosis pharmacotherapies for patients at high risk of bone loss and/or fracture., Conclusion: This executive summary reports and summarizes the main recommendations published previously, including bone assessment, dietary and lifestyle recommendations and osteoporosis medication., (© 2021 Published by Elsevier GmbH.)

The following Consensus Statement is endorsed by The International Menopause Society, The North American Menopause Society, The Endocrine Society, The European Menopause and Andropause Society, The Asia Pacific Menopause Federation, The International Osteoporosis Foundation and The Federation of Latin American Menopause Societies., (Copyright © 2016 International Menopause Society, Elsevier Ireland Ltd. Published by Elsevier Ireland Ltd.. All rights reserved.)

Osteoporosis is a common, costly and serious disease, which is still too often regarded as an inevitable part of the normal ageing process and therefore sub-optimally treated, especially in the elderly--in fact, only two out of every 10 patients who sustain a hip fracture receive any form of assessment or prophylactic therapy for osteoporosis. One out of five patients die within 1 year after a hip fracture, and < 50% are capable of leading an independent life. Yet very effective anti-fracture therapy, capable of reducing fracture risk by 35 - 60%, is available. A number of publications have recently questioned the safety of drugs routinely used to treat patients with osteoporosis. This paper attempts to put the situation into perspective and expresses the National Osteoporosis Foundation of South Africa's view on the safety of these drugs. Their efficacy in preventing skeletal fractures and their cost-effectiveness are not addressed in any detail. The paper emphasises the fact that all osteoporosis medications have side-effects, some of which are potentially life-threatening.

Neonatal pancreatic function was assessed in infants born to non-diabetic mothers and to mothers with well-controlled gestational diabetes (GD) and overt diabetes (OD) using cord blood C-peptide estimations and the calculation of cord C-peptide/glucose ratios. Exaggerated pancreatic function was present in infants born to mothers with GD. In these infants the increased cord C-peptide values and cord C-peptide/glucose ratios correlated with their increased birth weight ratios. These results could not be explained on the basis of maternal hyperglycaemia and a possible intrinsic difference in pancreatic response between infants born to mothers with GD and those born to mothers with OD is suggested.

Intra-uterine insemination with washed spermatozoa of the husband was evaluated in 42 infertile couples during 103 treatment cycles. A pregnancy rate of 47.3% was obtained after an average of 2 treatment cycles in a group of patients in whom hostile cervical mucus was the only known cause of infertility. A pregnancy rate of 21.7% was obtained after an average of 2.6 treatment cycles in a group of patients in whom low sperm morphology was the only known cause of infertility. The overall conception rate of 33.3% compares favourably with that in other published series.