Satisfaction and medication adherence in women with vulvovaginal atrophy: the CRETA.

OBJECTIVE: This study aimed to evaluate the self-reported satisfaction of Spanish postmenopausal women currently treated for vulvovaginal atrophy (VVA) symptoms. METHODS: The CRETA (CRoss sectional European sTudy on Adherence) is a multicenter cross-sectional study conducted in 29 public and private hospitals in Spain, which enrolled postmenopausal women receiving treatment with ospemifene, local hormone therapy (HT) or vaginal moisturizers for VVA. After the prior informed consent of the patients, sociodemographic and treatment perception data were collected using a structured questionnaire. RESULTS: Among 752 women who completed the survey, the satisfaction score was significantly higher for the group treated with ospemifene (mean 8.3 ± 1.4) compared with the local HT group (7.2 ± 1.7) and the vaginal moisturizer group (6.5 ± 2.1) according to a 10-point Likert scale (p < 0.0001). Compared to vaginal moisturizers and local HT, participants treated with ospemifene reported the highest adherence (96.7% vs. 70.2% and 78.6%, respectively) and the lowest number of missed doses in the last month (0.6 ± 1.3 standard deviation [SD] vs. 3.5 ± 4.3 SD and 2.0 ± 2.8 SD, respectively) (p < 0.0001). Ospemifene was significantly perceived as easy to use (83.9% vs. 44.9% and 58.6%, respectively; p < 0.0001), efficacious in reducing the time to relieve symptoms (17.1% vs. 7.0% and 6.7%, p = 0.0005 and p = 0.0006, respectively) and convenient for sexual life (53.1% vs. 25.6% and 42.3%, p < 0.0001 and p = 0.0234, respectively). CONCLUSIONS: Among postmenopausal women with VVA, treatment with ospemifene has the most positive perceptions and the highest overall satisfaction level and could be an optimal therapeutic approach, maximizing patient adherence.

Consenso Delphi sobre Estrategias Terapéuticas y de Prevención Sanitaria de la hipovitaminosis D / Delphi Consensus on Therapeutic and Preventive Health Strategies for Hypovitaminosis D

Antecedentes: La elevada prevalencia de hipovitaminosis D en España es considerada una verdadera epidemia con importantes implicaciones para la salud por las múltiples funciones que ejerce la vitamina D tanto a nivel esquelético como extraesquelético. Para que las personas con insuficiencia o deficiencia en vitamina D alcancen los niveles séricos más adecuados, deben recibir suplementos de vitamina D. Este estudio se realizó con la finalidad de evaluar si en la práctica clínica habitual, el manejo de la hipovitaminosis D era llevada a cabo según las recomendaciones internacionales establecidas por las sociedades científicas.Métodos: Se realizaron dos rondas de circulación de un cuestionario Delphi entre un panel formado por médicos prescriptores habituales de vitamina D.Resultados: En general, los médicos del panel reconocieron la alta prevalencia de la hipovitaminosis D en España, la necesidad del cribado en los distintos grupos de riesgo y los beneficios de la suplementación en los pacientes con insuficiencia o déficit de vitamina D. Sin embargo, no se alcanzó el consenso en algunas de las aseveraciones relacionadas con los métodos de cuantificación de la vitamina D o con las recomendaciones para el manejo de la hipovitaminosis D.Conclusiones: La ausencia de acuerdo para algunos de los ítems reveló la necesidad de realizar acciones formativas destinadas a proporcionar un conocimiento adecuado y actualizado sobre las evidencias científicas y las recomendaciones para la práctica clínica de la suplementación de vitamina D. (AU)

A prospective study of DT56a (Femarelle®) for the treatment of menopause symptoms.

BACKGROUND: DT56a (Femarelle®) is a natural medication that contains a variety of phytoestrogens derived from tofu. Treatment with DT56a affects bones, vascular tissues and the nervous system in a manner similar to that of estrogen but DT56a acts as an estrogen antagonist in breast and uterine tissues. AIM: The objective of this study was to analyze the efficacy of DT56a in the reduction of menopause symptoms in Spanish women who participated in the Post Marketing Menopausal Symptoms International Survey (POMMSIS). PATIENTS AND METHODS: A total of 631 Spanish menopausal or perimenopausal women with vasomotor symptoms who took DT56a for 4 weeks participated in this study. This study was an observational, questionnaire-based investigation that consisted of a baseline questionnaire, a hot flushes daily diary and a feedback questionnaire. RESULTS: A statistically significant (p < 0.01) reduction in the number and intensity of hot flushes was experienced after 2 and 4 weeks of DT56a treatment. After 4 weeks of treatment with DT56a, 80.7% of the patients reported that their hot flushes were 'better' or 'much better'. The severity of hot flushes was also reduced by 38% in all study participants and by 36% in women who had experienced more than seven hot flushes per day initially, before treatment. CONCLUSION: Treatment with DT56a resulted in a significant reduction in the number and intensity of hot flushes in postmenopausal women, especially in those with frequent symptoms, and these effects were observed within the first month of treatment.

Efficacy and safety of a phyto-SERM as an alternative to hormone therapy.

In this review, we analyze the efficacy and safety of DT56a in the treatment of postmenopausal symptoms. Similar to all selective estrogen receptor modulators (SERMs), DT56a demonstrates dual agonistic and antagonistic effects due to the synergy between its components. DT56a is referred to as a plant-origin SERM (phyto-SERM) and, for this reason, its therapeutic capacity in postmenopausal women differs from other phytoestrogens used independently. Although interesting data on relief of vasomotor symptoms have been reported for DT56a, further clinical studies with a greater number of cases and a longer period of study are required to correctly identify its indications for use as an alternative to hormone therapy, especially in preventing osteoporosis.

Position of the Spanish Menopause Society regarding the management of perimenopause.

Perimenopause is an imprecise period in woman over 40 years of age, which comprises the time between the moment that the first changes in the menstrual cycle appear and the year following the definitive cessation of the menses. Besides irregular bleeding, many women also complain of hot flashes and other characteristic symptoms of postmenopause. Moreover, most of them are concerned about the future impact that these events may have on their health, such as needing health exams or continuing to use contraceptive methods. A panel of experts from the Spanish Menopause Society has met to establish diagnostic and therapeutic guidelines for this period based on the best available evidence.

Estrogen-related genes and postmenopausal osteoporosis risk.

BACKGROUND: To date, more than 150 candidate genes related to osteoporosis have been described, but osteoporosis has increasingly been considered a polygenic disease modulated by environmental factors. It is thought that osteoporosis predisposition, pathology, and treatment response depend on the interaction between different genes or between genes and environmental factors. OBJECTIVE: The aim of this study was to evaluate the relationship between the presence of single nucleotide polymorphisms (SNPs) in the estrogen metabolic pathway and the development of osteoporosis and to determine whether this relationship is monogenic or whether interactions between genes exist. MATERIALS AND METHODS: A multicentric study with 1980 postmenopausal Spanish women in five Spanish communities was conducted. The women completed a specific questionnaire that inquired about risk factors for osteoporosis. Data on participants' bone mineral density were obtained with dual-energy X-ray densitometers, and genetic data were obtained from frozen peripheral blood. RESULTS: The digenic protection combinations indicated involvement of the wild-type genotype (WT) of the 3'UTR marker for the CYP19A1 gene, the IVS4 marker of the same gene, and the BMP15 and FSHR genes. Among patients who carried two or more of the genotypes considered 'risky', the triple combination among markers of the ESR2 and NRIP1 genes with any of the two mutations of the analyzed markers of the BMP15 gene gave a mean T-score value of -2.32±0.91 (p = 0.02). CONCLUSION: Variants of the new candidate genes (NRIP and BMP15) can predispose patients to osteoporosis.

Recomendaciones sobre ranelato de estroncio en el tratamiento de la osteoporosis / Recommendations on strontium ranelate in the treatment of osteoporosis

Actualmente disponemos de diversas intervenciones que pueden reducir la incidencia de fracturas osteoporóticas, como son medidas higiénico-dietéticas, reducir el riesgo de caídas y tratamientos farmacológicos específicos. El ranelato de estroncio es el único fármaco antiosteoporótico con un mecanismo de acción dual, ya que inhibe la resorción a la vez que estimula la formación ósea. Los estudios realizados demuestran su capacidad para mejorar los parámetros de calidad ósea (microarquitectura), aumentar la densidad mineral ósea y reducir el riesgo de fracturas vertebrales y no vertebrales. Ha demostrado eficacia en mujeres osteopénicas y osteoporóticas, tanto con fracturas como sin ellas, y tanto en los primeros años después de la menopausia como en las mujeres mayores. Existen datos de seguridad a 10 años en condiciones reales de administración, demostrando tener un adecuado perfil de seguridad y tolerancia. El ranelato de estroncio, debido a su eficacia, seguridad y años de experiencia, es un tratamiento de primera elección para las mujeres con osteoporosis posmenopáusica y riesgo de fractura (AU)

At present, several interventions are available to reduce the incidence of osteoporotic fractures, such as lifestyle modifications, reducing the risk of falls and specific pharmacological treatments. Strontium ranelate is the only anti-osteoporotic drug with a dual mechanism of action, since it inhibits bone resorption while stimulating bone formation. The studies performed to date have shown the ability of this drug to improve bone quality parameters (microarchitecture), increase bone mineral density and reduce the risk of vertebral and nonvertebral fractures. Strontium ranelate has demonstrated efficacy in osteopenic and osteoporotic women, with or without fractures, in the first few years after menopause and in older women. Safety data are available for 10 years and under real conditions of administration, and demonstrate an adequate safety profile and tolerance. Due to its efficacy, safety and years of use, strontium ranelate is a first choice treatment for women with postmenopausal osteoporosis and fracture risk (AU)

Anticoncepción con sólo-gestágenos. Controversias / Progestin-only contraception. Controversies

La anticoncepción con métodos sólo-gestágenos constituye una excelente alternativa para aquellas mujeres que tienen contraindicado el uso de estrógenos o bien no los toleran. Por el hecho de no contener estrógenos, estos métodos se asocian con una menor incidencia de efectos metabólicos adversos. A pesar de ello, hay cierta discusión y controversia en cuanto a su seguridad sobre la hemostasia (tromboembolismo venoso), la masa ósea (menor pico de masa ósea) o el tejido mamario (aumento en el riesgo de cáncer de mama). Hemos revisado la evidencia científica sobre estos aspectos controvertidos con los métodos sólo-gestágenos disponibles actualmente en España: la minipíldora (Cerazet®), inyectables (Depo-Progevera®), implante subcutáneo (Implanon®) y el sistema intrauterino liberador de levonorgestrel (Mirena®). (AU)

Ethinyl oestradiol plus dl-norgestrel or levonorgestrel in the Yuzpe method for post-coital contraception: results of an observational study.

This observational study compares the efficacy and incidence of side-effects between dl-norgestrel (2 mg) and levonorgestrel (1 mg) associated with ethinyl oestradiol (200 micrograms) given in two doses 12 h apart for emergency post-coital contraception. A total of 117 consecutive women were given dl-norgestrel in combination with the oestrogen (dl-norgestrel group) while 423 consecutive subjects received the combination ethinyl oestradiol/levonorgestrel (levonorgestrel group). Overall, four (0.8%) pregnancies occurred in the 540 treated women, one (0.9%) in the dl-norgestrel group and three (0.7%) in the levonorgestrel group. In addition to this similar high contraceptive efficacy between both study groups, women in the levonorgestrel group had a significantly lower incidence of side-effects (23.5%) and better timing of the next menstruation after treatment (75% had bleeding on time) than those in the dl-norgestrel group (corresponding figures were 50.5 and 62.6% respectively). It is concluded that levonorgestrel should be used in preference to dl-norgestrel for post-coital contraception in the Yuzpe regimen.