RESUMO
The increasing prevalence of obesity imposes significant health challenges, particularly in women undergoing menopause. Effective obesity management is essential to mitigate associated comorbidities and improve quality of life. The pillars of obesity treatment encompass lifestyle modifications, pharmacotherapy and surgical interventions. Pharmacotherapy may be considered for women who do not achieve adequate weight loss through lifestyle changes alone and have obesity or overweight with risk factors. Bariatric surgery is reserved for individuals with severe obesity or those with obesity-related complications. During menopause, hormonal changes contribute to weight gain and fat redistribution, complicating obesity management. Tailored treatment strategies are necessary to address the unique challenges faced by this population. The role of physicians and gynecologists is pivotal in the multidisciplinary approach to obesity management during menopause. Gynecologists are often the primary health-care providers for menopausal women and are in a unique position to offer guidance on weight management. They can provide personalized counseling, coordinate with nutritionists, endocrinologists and bariatric specialists, and monitor the effects of obesity and its treatment on reproductive health. By integrating obesity management into routine gynecological care, gynecologists can significantly impact the overall health and well-being of menopausal women.
Assuntos
Cirurgia Bariátrica , Menopausa , Obesidade , Humanos , Feminino , Menopausa/fisiologia , Obesidade/terapia , Qualidade de Vida , Redução de Peso , Pessoa de Meia-Idade , Ginecologia , Estilo de VidaRESUMO
Many women seek treatment to improve menopausal vasomotor symptoms (VMS). The selection of women most likely to benefit from menopause hormone therapy (MHT) is crucial in clinical practice. There is general agreement that women younger than 60 years or who initiate MHT within the first 10 years of menopause, with no contraindications, have greater benefits considering symptomatic relief and additional advantages. This group may have the advantage of protection from osteoporosis and from other chronic diseases that affect postmenopausal women, namely cardiovascular disease (CVD). Cumulating evidence supports MHT for symptomatic women. However, inadequate use according to the needs of symptomatic women led to a burden of suffering worldwide. In recent years, the emergent use of non-regulated body-identical hormones (non-rBHT) can expose patients to potential harms. These hormone preparations are not regulated through the same tests of safety, efficacy or dosing consistency as regulated-BHT (r-BHT). The POESIT (Portugal + Spain + Italy) recommendations highlight the use of 17ß-estradiol (E2) and micronized progesterone (P4) as the real r-BHT. In addition, the group emphasizes as an example the data from the REPLENISH study with 1 mg E2/100 mg P4. The combination of the two hormones in one convenient pill showed a clear reduction or elimination of hot flashes and an improvement in sleep quality and, consequently, quality of life. At the same time, this combination has shown high rates of amenorrhea and no significant impact on lipid, glucose or coagulation parameters. Both the REPLENISH study and a real-life retrospective study pointed to the possibility of a lower risk of venous thromboembolism (VTE) with this formulation than with other combinations.
Assuntos
Estradiol , Terapia de Reposição de Estrogênios , Fogachos , Menopausa , Progesterona , Humanos , Feminino , Fogachos/tratamento farmacológico , Estradiol/administração & dosagem , Progesterona/administração & dosagem , Progesterona/uso terapêutico , Terapia de Reposição de Estrogênios/métodos , Pessoa de Meia-Idade , Qualidade de Vida , Espanha , ItáliaRESUMO
INTRODUCTION: Osteoporosis is a chronic systemic skeletal disorder characterized by compromised bone strength and an increased risk of fracture, with a high prevalence worldwide. It is associated with a negative quality of life and an increased morbidity and mortality. Postmenopausal women are more prone to develop osteoporosis, and many of them will suffer at least one fragility fracture along their lifetime. AREAS COVERED: This review starts by summarizing the pathogenesis of postmenopausal osteoporosis (PMO), with focus on the estrogen deficiency-associated bone loss. It continues with the current PMO diagnostic and fracture risk prediction tools, and it finally addresses management of PMO. All the efficacy and safety profiles of the current and future osteoporosis medications are reviewed. Furthermore, strategies to optimize the long-term disease management are discussed. For this review, only publications in English language were selected. References were extracted from PubMed, Embase, and Medline. EXPERT OPINION: PMO disease management is far from being ideal. Educational and communication programs with the goal of improving disease knowledge and awareness, as well as reducing the health-care gap, should be implemented. In addition, most effective sequential prevention and treatment strategies should be initiated from the early menopause.
Assuntos
Conservadores da Densidade Óssea , Osteoporose Pós-Menopausa , Fraturas por Osteoporose , Qualidade de Vida , Humanos , Feminino , Osteoporose Pós-Menopausa/tratamento farmacológico , Conservadores da Densidade Óssea/uso terapêutico , Fraturas por Osteoporose/prevenção & controle , Estrogênios/uso terapêuticoRESUMO
Background: In recent years, new combined oral contraceptives (COCs) have become available, representing an advance in terms of individualization and compliance by users.Objective: To provide recommendations regarding COCs: formulations, use, efficacy, benefits and safety.Method: For these recommendations, we have used the modified Delphi methodology and carried out a systematic review of studies found in the literature and reviews performed in humans, published in English and Spanish in Pubmed, Medline and advanced medicine and computer networks until the year 2021, using the combination of terms: 'oral contraceptives', 'estroprogestins' and 'combined oral contraceptives'.Results: Regarding the estrogen component, initially switching from mestranol (the pro-drug of ethinylestradiol) to ethinylestradiol (EE) and then reducing the EE dose helped reduce side effects and associated adverse events. Natural estradiol and estradiol valerate are already available and represent a valid alternative to EE. The use of more potent 19-nortestosterone-derived progestins, in order to lower the dose and then the appearance of non-androgenic progestins with different endocrine and metabolic characteristics, has made it possible to individualize the prescription of COC according to the profile of each woman.Conclusion: Advances in the provision of new COCs have improved the risk/benefit ratio by increasing benefits and reducing risks. Currently, the challenge is to tailor contraceptives to individual needs in terms of safety, efficacy, and protection of female reproductive health.
Assuntos
Anticoncepcionais Orais Combinados , Progestinas , Feminino , Humanos , Anticoncepcionais Orais Combinados/efeitos adversos , Progestinas/uso terapêutico , América Latina , Etinilestradiol/efeitos adversos , Estrogênios/efeitos adversos , Saúde da MulherRESUMO
OBJECTIVES: The objective is to assess the perception of gynecologists regarding patients' adherence to vulvovaginal atrophy (VVA) treatments, to evaluate the gynecologists' opinions on what their patients think about treatment adherence, and to compare the gynecologists' opinions with the patients' own perceptions within the CRETA study. METHODS: Spanish gynecologists who participated in the CRETA study were asked to fill out an online 41-item questionnaire to evaluate their views on VVA management. RESULTS: From 29 centers across Spain, 44 gynecologists completed the survey. Their mean age was 47.2 years old, two-thirds of them were women, and the average professional experience was over 20 years. According to the gynecologists, the therapy most frequently used by VVA-diagnosed women was vaginal moisturizers (45.5%), followed by local estrogen therapy (36.4%) and ospemifene (18.2%). Nevertheless, ospemifene was viewed as the therapeutic option with the most efficacy, easiest route of administration, shorter time to symptom improvement, lower percentage of dropouts, and higher treatment adherence. CONCLUSIONS: Spanish gynecologists are in general agreement with their patients regarding VVA treatment preferences and the main issues for adherence and effectiveness. However, there is an opportunity for doctor-patient communication improvement. Among the three therapeutic options evaluated, ospemifene is regarded as offering some competitive advantages.
Assuntos
Ginecologista , Tamoxifeno , Vagina , Doenças Vaginais , Vulva , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Atrofia/tratamento farmacológico , Atrofia/patologia , Atenção à Saúde , Percepção , Pós-Menopausa , Tamoxifeno/uso terapêutico , Vagina/patologia , Doenças Vaginais/tratamento farmacológico , Doenças Vaginais/patologia , Vulva/patologia , Cooperação e Adesão ao TratamentoRESUMO
Increased life expectancy means that women are now in a hypoestrogenic state for approximately one-third of their lives. Overall health and specifically bone health during this period evolves in accordance with aging and successive exposure to various risk factors. In this review, we provide a summary of the approaches to the sequential management of osteoporosis within an integrative model of care to offer physicians a useful tool to facilitate therapeutic decision-making. Current evidence suggests that pharmacologic agents should be selected based on the risk of fractures, which does not always correlate with age. Due to their effect on bone turnover and on other hormone-regulated phenomena, such as hot flushes or breast cancer risk, we position hormone therapy and selective estrogen receptor modulators as an early postmenopause intervention for the management of postmenopausal osteoporosis. When the use of these agents is not possible, compelling evidence supports antiresorptive agents as first-line treatment of postmenopausal osteoporosis in many clinical scenarios, with digestive conditions, kidney function, readiness for compliance, or patient preferences playing a role in choosing between bisphosphonates or denosumab during this period. For patients at high risk of osteoporotic fracture, the "anabolic first" approach reduces that risk. The effect on bone health with these bone-forming agents or with denosumab should be consolidated with the subsequent use of antiresorptive agents. Regardless of the strategy, follow-up and treatment should be maintained indefinitely to help prevent fractures.
RESUMO
OBJECTIVE: To assess the correlation of different vulvovaginal atrophy therapeutic options with the quality of life of postmenopausal women. STUDY DESIGN: The CRETA study is a descriptive, observational, cross-sectional, multicenter study designed to measure, besides treatment satisfaction and adherence, the quality of life of postmenopausal women diagnosed with vulvovaginal atrophy in 29 hospitals and centers across Spain. MAIN OUTCOME MEASURES: The study enrolled postmenopausal women currently receiving treatment with vaginal moisturizers, local estrogen therapy or ospemifene. Clinical features and treatment perceptions were collected by self-report questionnaire and quality of life was evaluated using the Cervantes scale. RESULTS: Among the 752 women included, the ospemifene cohort showed a statistically significant lower global score (44.9 ± 21.7) on the Cervantes scale (and therefore, a better quality of life) than the cohorts treated with moisturizers (52.5 ± 21.6, p = 0.003) or local estrogen therapy (49.2 ± 23.8, p = 0.0473). In the analysis by domains, ospemifene-treated women showed statistically significant better scores in menopause & health and psychological status than moisturizers-treated women (p < 0.05). In the domains of sexuality and couple relations, the score for the quality of life of the ospemifene cohort was statistically significantly better than the scores in either of the cohorts treated with moisturizers (p < 0.001) or local estrogen therapy (p < 0.05). CONCLUSIONS: Postmenopausal women diagnosed with vulvovaginal atrophy and treated with ospemifene have better quality of life than women treated with vaginal moisturizers or local estrogen therapy. The improvement observed with ospemifene is more remarkable in those aspects related to sex life and couple relations. CLINCIALTRIALS. GOV NUMBER: NCT04607707.
Assuntos
Dispareunia , Moduladores Seletivos de Receptor Estrogênico , Feminino , Humanos , Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Pós-Menopausa , Vagina/patologia , Qualidade de Vida , Estudos Transversais , Dispareunia/patologia , Tamoxifeno/uso terapêutico , Estrogênios/uso terapêutico , Atrofia/tratamento farmacológico , Atrofia/patologia , Vulva/patologiaRESUMO
OBJECTIVES: The Women's Health Initiative study reported an increased risk of venous thromboembolism among menopausal women treated with conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA) versus placebo. Newer hormone therapies may have a lower venous thromboembolism risk. The study compared the risk of venous thromboembolism between women treated with the combined oral product 17ß-estradiol/micronized progesterone (E2/P4) and those treated with oral CEE/MPA regimens. STUDY DESIGN: In a retrospective longitudinal study using real-world claims data from April 2019 to June 2021, women aged 40 years or more treated with oral E2/P4 or oral CEE/MPA who did not have a venous thromboembolism diagnosis before first dispensing claim of CEE/MPA or E2/P4 identified on or after May 1st 2019 (index date) were observed for 6 months or more after the index date. Oral E2/P4 and oral CEE/MPA had been prescribed by the treating physician in real-world practice and were observed through pharmacy dispensing records. MAIN OUTCOME MEASURES: Venous thromboembolism risk was compared between women receiving oral E2/P4 versus oral CEE/MPA. RESULTS: The study included 36,061 women treated with oral E2/P4 or oral CEE/MPA. In the analyses weighted by the inverse probability of treatment for control of potential confounding factors, the incidence of venous thromboembolism was significantly lower for oral E2/P4 compared with oral CEE/MPA (37/10,000 women-years for oral E2/P4 vs 53/10,000 women-years for oral CEE/MPA; incidence rate ratio 0.70, 95 % confidence interval: 0.53-0.92). CONCLUSIONS: Real-world evidence suggests that the risk of venous thromboembolism is significantly lower among women treated with oral E2/P4 compared with oral CEE/MPA.
Assuntos
Estrogênios Conjugados (USP) , Tromboembolia Venosa , Feminino , Humanos , Estrogênios Conjugados (USP)/efeitos adversos , Progesterona/efeitos adversos , Acetato de Medroxiprogesterona/efeitos adversos , Estradiol , Tromboembolia Venosa/induzido quimicamente , Tromboembolia Venosa/epidemiologia , Estudos Longitudinais , Estudos Retrospectivos , Terapia de Reposição de Estrogênios/efeitos adversosRESUMO
OBJECTIVES: Progestins used in contraception are either components of combined hormonal contraceptives or are used as a single active ingredient. Progestins are highly effective in long-term contraception and have a very good safety profile with very few contraindications. METHODS: An oestrogen-free ovulation inhibitor POP has been authorised in the USA and the EU. It contains 4 mg of drospirenone (DRSP). The hormone administration regimen of 24 days followed by a 4-day hormone-free period was chosen to improve bleeding control and to maintain oestradiol concentrations at early follicular- phase levels, preventing oestrogen deficiency. RESULTS: Clinical trials have demonstrated high contraceptive effectiveness, a very low risk of cardiovascular risk events and a favourable bleeding pattern. Due to the long half-life of DRSP (30-34 h), the effectiveness is maintained even in case of a forgotten pill on a single occasion. Studies involving deliberate 4 days in one cycle 24-hour delays in taking a pill have demonstrated that ovulation inhibition is maintained if a single pill is missed. CONCLUSIONS: This review article will describe the clinical impact in the daily use of the 4 mg DRSP only pill and the resulting data on the effectiveness and safety of this hormonal contraceptive.
The 4 mg drospirenone-only pill improves the bleeding profile in comparison to 0.075 mg desogestrel and achieves high contraceptive efficacy even with a 24 h missed pill window.
Assuntos
Androstenos , Progestinas , Feminino , Humanos , Androstenos/efeitos adversos , Anticoncepção/métodos , Estradiol , Anticoncepcionais , Anticoncepcionais Orais CombinadosRESUMO
Resumen OBJETIVO: Determinar las concentraciones de 25(OH)D en ginecoobstetras y otros especialistas latinoamericanos y conocer la prevalencia de su deficiencia. MATERIALES Y MÉTODOS: Estudio transversal y observacional efectuado para determinar las concentraciones de 25(OH)D en médicos voluntarios, sobre todo ginecoobstetras, que acudieron a diferentes congresos en distintos países latinoamericanos. RESULTADOS: Se analizaron 643 determinaciones. El 19.4% tenían déficit (media 16.58 ng/mL), 72% insuficiencia (media 24.6 ng/mL) y 36.9% concentraciones normales (media 40.34 ng/mL). Los hombres tuvieron mayor déficit-insuficiencia (62.8%) que las mujeres (59.5%), pero sin diferencias significativas (p < 0.058). Las personas de piel clara tuvieron concentraciones deficitarias e insuficientes, menores que las de piel oscura (p < 0.001). Quienes tomaban suplementos de vitamina D tuvieron menor riesgo de déficit. CONCLUSIONES: El 60% de los ginecoobstetras, médicos internistas y generales de Latinoamérica tienen bajas concentraciones de 25(OH)D. La piel clara puede ser un factor de riesgo de mayor déficit-insuficiencia. En los grupos de médicos estudiados la suplementación con vitamina D parece incrementar las concentraciones de 25(OH)D.
OBJECTIVE: To determine 25(OH)D concentrations in obstetrician-gynecologists and other Latin American specialists and to know the prevalence of its deficiency. MATERIALS AND METHODS: Cross-sectional and observational study to determine 25(OH)D concentrations in volunteer physicians, mainly gynecologists, attending different congresses in different Latin American countries. RESULTS: A total of 643 determinations were analysed. 19.4% had deficiency (mean 16.58 ng/mL), 72% insufficiency (mean 24.6 ng/mL), and 36.9% normal concentrations (mean 40.34 ng/mL). Men had higher deficiency-insufficiency (62.8%) than women (59.5%), but no significant differences (p < 0.058). Light-skinned people had lower insufficiency levels than darker-skinned people (p < 0.001). Those taking vitamin D supplements had a lower risk of deficiency. CONCLUSIONS: Sixty percent of obstetrician-gynecologists, internists, and general practitioners in Latin America have low 25(OH)D concentrations. Caucasian skin may be a risk factor for increased deficiency. Vitamin D supplementation appears to improve 25(OH)D concentrations in the physician groups studied.
RESUMO
This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms.
Assuntos
Neoplasias da Mama , Terapia de Reposição de Estrogênios , Menopausa , Feminino , Humanos , Neoplasias da Mama/induzido quimicamente , Terapia de Reposição de Estrogênios/efeitos adversos , Pessoal de Saúde , Sociedades CientíficasRESUMO
Dynamic contacts are formed between endoplasmic reticulum (ER) and mitochondria that enable the exchange of calcium and phospholipids. Disturbed contacts between ER and mitochondria impair mitochondrial dynamics and are a molecular hallmark of Parkinson's disease, which is also characterized by impaired complex I activity and dopaminergic neuron degeneration. Here, we analyzed the role of cysteine-rich with EGF-like domain (Creld), a poorly characterized risk gene for Parkinson's disease, in the regulation of mitochondrial dynamics and function. We found that loss of Creld leads to mitochondrial hyperfusion and reduced ROS signaling in Drosophila melanogaster, Xenopus tropicalis, and human cells. Creld fly mutants show differences in ER-mitochondria contacts and reduced respiratory complex I activity. The resulting low-hydrogen peroxide levels are linked to disturbed neuronal activity and lead to impaired locomotion, but not neurodegeneration, in Creld mutants. We conclude that Creld regulates ER-mitochondria communication and thereby hydrogen peroxide formation, which is required for normal neuron function.
Assuntos
Drosophila melanogaster , Doença de Parkinson , Animais , Neurônios Dopaminérgicos/metabolismo , Drosophila melanogaster/genética , Drosophila melanogaster/metabolismo , Retículo Endoplasmático/metabolismo , Humanos , Peróxido de Hidrogênio/metabolismo , Mitocôndrias/genética , Mitocôndrias/metabolismo , Doença de Parkinson/genética , Doença de Parkinson/metabolismoRESUMO
OBJECTIVE: To assess the improvement in vulvovaginal atrophy (VVA) of postmenopausal women treated with oral ospemifene 60 mg/day under conditions of routine clinical practice after 12 months of follow-up. METHODS: The AYSEX study is a Spanish observational, prospective, and unicentric study in which five gynecologists recruited postmenopausal women with VVA in routine clinical practice treated with oral ospemifene 60 mg/day as an appropriate therapeutic option. Vaginal health, the most bothersome symptoms, sexual health, endometrial safety, bone resorption markers, bone densitometry, mammography, treatment satisfaction, and quality of life were assessed at baseline and after 12 months using appropriate scales. RESULTS: A total of 100 postmenopausal women cytologically and clinically diagnosed with VVA were included in the study. After 3 months of treatment with ospemifene, a significant improvement was observed in all domains of Vaginal Health Index. This improvement was maintained at month 12 and only one patient remained with vaginal atrophy. In addition, a significant improvement was observed in the most bothersome symptoms, sexual function, and quality of life. There was no significant change in endometrial thickness, mammography, and bone health during the 12 months of treatment. CONCLUSIONS: This study in routine clinical practice conditions confirms the results previously reported by randomized controlled trials, including a significant improvement in VVA, sexual function, quality of life, endometrial safety, and satisfaction with the treatment.
Assuntos
Dispareunia , Doenças Vaginais , Atrofia/tratamento farmacológico , Atrofia/patologia , Dispareunia/tratamento farmacológico , Feminino , Seguimentos , Humanos , Estudos Prospectivos , Qualidade de Vida , Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Tamoxifeno/análogos & derivados , Resultado do Tratamento , Vagina/patologia , Doenças Vaginais/patologia , Vulva/patologiaRESUMO
Subfertility is more than a quality-of-life problem as it has a substantial negative public health impact. Polycystic ovary syndrome (PCOS) is one of the most common causes of subfertility, affecting one out of 10 women in reproductive age. Among PCOS women undergoing assisted reproductive technology, treatment based on myo-inositol and high doses of D-chiro-inositol has been shown to increase pregnancy rate and number of live births, reduce ovarian hyperstimulation syndrome and improve oocyte quality. A preparation based on myo-inositol and high doses of D-chiro-inositol, together with antioxidants, vitamins, and minerals, could have beneficial effects and be an optimal strategy to improve female fertility in the general gynecologist's office. The aim of this review is to highlight the role of inositol and its isomers in improving fertility of women with PCOS.
Assuntos
Inositol , Síndrome do Ovário Policístico , Antioxidantes/uso terapêutico , Feminino , Fertilidade , Humanos , Inositol/uso terapêutico , Síndrome do Ovário Policístico/complicações , Síndrome do Ovário Policístico/tratamento farmacológico , Gravidez , Taxa de GravidezRESUMO
OBJECTIVE: To assess vaginal health, endometrial thickness, and changes in bone markers in postmenopausal women with vulvovaginal atrophy (VVA) treated with 60 mg/day of ospemifene under routine clinical practice. METHODS: The AYSEX study is a Spanish observational and prospective study performed in one center in which 5 gynecologists recruited postmenopausal women with VVA in routine clinical practice treated continuously with ospemifene 60 mg/day for 12 months as an appropriate therapeutic option. This article refers to the 3- and 6-months analysis. Vaginal health was assessed by pH and using Vaginal Health Index (VHI) at baseline and 3 months later. Endometrial thickness, measured by vaginal ultrasonography, and bone resorption marker (CTx) were assessed at baseline and 6 months later. RESULTS: A total of 100 postmenopausal women cytologically and clinically diagnosed with VVA were included in the study. After 3 months of treatment with ospemifene, pH improved from 6.1 to 4.5 (p < .0001), and VHI improved from 10 to 19 points (p < .0001). The percentage of patients with VVA according to VHI decreased from 100% to 5.2% (p < .0001). After 6 months, mean CTx levels decreased from 0.42 pg/ml at baseline to 0.37 pg/ml 6 months later (p = .0018), and mean endometrial thickness changed from 2.24 to 2.15 mm (p = .6066). CONCLUSIONS: Up to date, this is the only prospective and observational study with ospemifene in routine clinical practice conditions and confirms the results previously reported from randomized controlled clinical trials, improving VVA, not increasing endometrial thickness, and decreasing CTx levels by exerting an anti-resorptive function.
Assuntos
Osso e Ossos/fisiologia , Endométrio/anatomia & histologia , Pós-Menopausa/fisiologia , Tamoxifeno/análogos & derivados , Vagina/fisiologia , Biomarcadores/sangue , Reabsorção Óssea , Osso e Ossos/efeitos dos fármacos , Endométrio/efeitos dos fármacos , Feminino , Humanos , Pós-Menopausa/efeitos dos fármacos , Estudos Prospectivos , Tamoxifeno/administração & dosagem , Ultrassonografia , Vagina/efeitos dos fármacosRESUMO
OBJECTIVES: Progestin-only pills do not increase the risk of venous thromboembolism, stroke, and myocardial infarction but are associated with poor cycle control. A novel estrogen-free pill containing only drospirenone (DRSP) to improve bleeding patterns and tolerability and reduce discontinuation rates has been introduced into the market. The present study aims to describe the improvement in the acceptability of this DRSP-only pill, e.g. regarding the bleeding profile and the reduction in discontinuation rates due to unacceptable bleeding compared to desogestrel (DSG). STUDY DESIGN: Double-blind, double-dummy prospective phase III study in healthy women aged 18-45 years evaluating a total of 858 women with 6691 DRSP and 332 women with 2487 DSG treatment cycles. RESULTS: Overall, 82 (9.6%) women in the DRSP group and 44 (13.3%) women in the DSG group experienced treatment-emergent adverse events (TEAEs) leading to premature termination of the trial meaning that 32% more women in the DRSP group finished the trial in comparison to the DSG group (based on the AUC of Kaplan-Meier's curves). Discontinuation rates due to abnormal bleeding were 3.7% for DRSP and 7.3% for DSG users. This is a 55.7% lower discontinuation rate in the DRSP group compared to the DSG group. CONCLUSIONS: This report describes the improvement in acceptability and bleeding profile of women using the new DRSP-only oral contraceptive compared to DSG, providing a better quality of life and adherence to the contraceptive method as demonstrated by lower discontinuation rates of women using the estrogen-free DRSP-only pill.
Assuntos
Androstenos/efeitos adversos , Anticoncepcionais Orais Hormonais/efeitos adversos , Desogestrel/efeitos adversos , Antagonistas de Receptores de Mineralocorticoides/efeitos adversos , Hemorragia Uterina/induzido quimicamente , Adulto , Androstenos/administração & dosagem , Anticoncepcionais Orais Hormonais/administração & dosagem , Desogestrel/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Adesão à Medicação , Antagonistas de Receptores de Mineralocorticoides/administração & dosagem , Estudos ProspectivosRESUMO
OBJECTIVE: The aim of the study was to evaluate the efficacy of Papilocare, a Coriolus versicolor-based vaginal gel, in repairing human papillomavirus (HPV)-related low-grade cervical lesions. METHODS: The study is a multicenter, open-label, randomized, parallel-group, watchful waiting approach-controlled trial involving 91 HPV-positive women with low-grade Pap smear alterations and consistent colposcopy. RESULTS: The percentage of patients with normal Pap smear and concordant colposcopy 3 and 6 months after receiving treatment (78.0% and 84.9%) was significantly higher than without treatment (54.8% and 64.5%), especially in high-risk HPV patients (79.5% and 87.8% vs 52.0% and 56.0%). At 6-month visit, overall HPV clearance was achieved by a greater number of patients receiving treatment (59.6%) compared with those without treatment (41.9%), especially high-risk HPV ones (62.5% vs 40.0%). The cervical re-epithelization score was significantly higher with treatment (mean = 4.5) than without (mean = 4.1). Compared with baseline, perceived stress decreased in the treatment group (from 21.1 to 19.0) and increased in the control group (from 17.7 to 20.7). A total of 7 possible or probable treatment-related adverse events were reported, most of them (n = 6) being mild or moderate in severity. CONCLUSIONS: Treatment with Papilocare has demonstrated a better clinical benefit than the conventional watchful waiting approach in clinical practice for total and high-risk HPV patients in terms of its efficacy to treat HPV-related cervical lesions and to clear all HPV strains after a single 6-month period. It has demonstrated an adequate safety and tolerability and confers additional benefits such as higher re-epithelization, stress reduction, and high treatment adherence.
Assuntos
Papillomaviridae/efeitos dos fármacos , Infecções por Papillomavirus/tratamento farmacológico , Polyporaceae , Displasia do Colo do Útero/tratamento farmacológico , Displasia do Colo do Útero/virologia , Neoplasias do Colo do Útero/tratamento farmacológico , Neoplasias do Colo do Útero/virologia , Cremes, Espumas e Géis Vaginais/farmacologia , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Espanha , Resultado do Tratamento , Neoplasias do Colo do Útero/patologia , Adulto Jovem , Displasia do Colo do Útero/patologiaRESUMO
OBJECTIVE: Women with history of breast cancer (HBC) frequently suffer from vulvovaginal atrophy (VVA). European Vulvovaginal Epidemiology Survey (EVES) sub-analysis assesses the impact of HBC on VVA, sexual life and quality of life (QoL) in postmenopausal women. MATERIALS AND METHODS: Women with at least one VVA symptom aged 45-75 years were included. EuroQol (EQ-5D-3L) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were filled to investigate QoL. VVA diagnosis was confirmed with objective gynecological examination. Comparison of postmenopausal women with and without HBC, and evaluation of treatment impact on VVA were performed. RESULTS: 1985 postmenopausal women without HBC and 175 with HBC were included. VVA was confirmed in 90.4% of women without HBC and 91.4% of women with HBC. There were no differences in VVA symptoms severity or vulvovaginal discomfort between groups. However, women with HBC who had completed treatment and had surgery 11-20 years previously versus those without HBC presented significantly worse Vaginal Health Index scores, as well as a higher prevalence of VVA objective diagnosis, although their overall symptom severity score was lower. Health status and QoL comparisons were similar. CONCLUSIONS: Results support a similar burden in terms of VVA prevalence and symptoms, QoL and sexual function in postmenopausal women with and without HBC.
Assuntos
Vaginite Atrófica/epidemiologia , Neoplasias da Mama/epidemiologia , Idoso , Antineoplásicos/efeitos adversos , Vaginite Atrófica/induzido quimicamente , Vaginite Atrófica/psicologia , Neoplasias da Mama/tratamento farmacológico , Feminino , Humanos , Itália/epidemiologia , Pessoa de Meia-Idade , Pós-Menopausa , Prevalência , Qualidade de Vida , Comportamento Sexual , Espanha/epidemiologia , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To assess the effect of ospemifene 60 mg/day in vulvovaginal atrophy (VVA) in postmenopausal women under conditions of routine clinical practice after 3 months of follow-up. METHODS: The AYSEX study is a Spanish observational, prospective, and unicentric study in which 5 gynecologists recruited postmenopausal women with VVA in routine clinical practice treated with ospemifene 60 mg/day as an appropriate therapeutic option. Vaginal health, sexual health, dryness, dyspareunia, quality of life, and satisfaction with treatment were assessed at baseline and after three months using validated scales. RESULTS: A total of 100 postmenopausal women cytologically and clinically diagnosed with VVA were included in the study. After 3 months of treatment with ospemifene, vaginal health index increased and vaginal pH, dryness, and dyspareunia decreased significantly (p < .0001). A significant improvement was observed in sexual function and quality of life. CONCLUSIONS: This study in routine clinical practice conditions confirms the results previously reported by randomized controlled trials, including a significant improvement in VVA, sexual function, quality of life, and satisfaction with the treatment.
Assuntos
Pós-Menopausa , Tamoxifeno/análogos & derivados , Doenças Vaginais/tratamento farmacológico , Doenças da Vulva/tratamento farmacológico , Adulto , Idoso , Atrofia/tratamento farmacológico , Atrofia/epidemiologia , Dispareunia/tratamento farmacológico , Dispareunia/epidemiologia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Satisfação Pessoal , Pós-Menopausa/efeitos dos fármacos , Estudos Prospectivos , Qualidade de Vida , Espanha/epidemiologia , Tamoxifeno/uso terapêutico , Resultado do Tratamento , Vagina/efeitos dos fármacos , Vagina/patologia , Doenças Vaginais/epidemiologia , Vulva/efeitos dos fármacos , Vulva/patologia , Doenças da Vulva/epidemiologiaRESUMO
Objetivo: determinar las características de los usuarios y servicios basados en el triaje. Método: estudio observacional descriptivo que incluyó pacientes que acudieron al servicio de urgencias y se les realizó triaje en dos instituciones de alto nivel de complejidad en Medellín en el año de 2018. Resultado: se incluyeron 4159 pacientes. La mediana de edad fue de 38 años, el 54,61 % eran de sexo masculino. El 85,54 % habitaban en el área metropolitana y el 67,78 % eran del régimen contributivo. En cuanto al mes con mayor afluencia de pacientes fue mayo con un 10,55 % seguido del mes de enero con 10,29 %; y el día de la semana fue el martes con 16,15 %, siendo el horario más frecuente entre las 9:00 y 12:00 del día con 18,32 %. Conclusión: una adecuada caracterización del paciente en urgencias por medio del triaje es útil para una atención oportuna y lograr la optimización de los servicios.
Objective: to determine the characteristics of users and services based on triage. Methods: descriptive observational study that included patients who attended the emergency department and underwent triage in two institutions of high level of complexity in Medellin in 2018. Results: 4159 patients were included. The median age was 38 years, 54.61 % were male. The 85.54 % lived in the metropolitan area and 67.78 % were in the contributory regime. The month with the highest number of patients was May with 10.55 %, followed by January with 10.29 %; and the day of the week was Tuesday with 16.15 %, the most frequent time being between 9:00 and 12:00 a.m. with 18.32 %. Conclusion: an adequate characterization of the patient in the emergency department by means of triage is useful for timely care and to achieve the optimization of services.
Objetivo: determinar as características dos usuários e dos serviços baseados na triagem. Método: estudo observacional descritivo que incluiu pacientes que compareceram ao departamento de emergência e foram submetidos à triagem em duas instituições de nível de alta complexidade em Medellín em 2018. Resultados: foram incluídos 4159 pacientes. A mediana de idade foi de 38 anos, 54,61% eram do sexo masculino. Os 85,54% residiam na região metropolitana e 67,78% estavam no regime contributivo. O mês com maior número de doentes foi maio com 10,55 %, seguido de janeiro com 10,29 %, e o dia da semana foi a terça-feira com 16,15 %, sendo a hora do dia mais frequente entre as 9:00 e as 12:00 com 18,32 %. Conclusão: a caraterização adequada dos doentes no SU através da triagem é útil para o atendimento atempado e otimização dos serviços.