RESUMO
OBJECTIVE: Hormone therapy (HT) prescription patterns have varied enormously over time and across specialties. The present study attempts to look at practice variation in specific controversial scenarios and to determine if attendance at The North American Menopause Society (NAMS) 2016 Annual Meeting, where the draft of the 2017 NAMS HT Position Statement was presented, had any impact on members' HT prescribing patterns. METHODS: An anonymous survey with 11 case scenarios was sent to all NAMS members before and after the 2016 NAMS Annual Meeting. Pre- and postmeeting responses were pooled into a single cohort. For those who responded to both surveys, only the postmeeting survey responses were included in the cohort. The impact of attendance at the 2016 NAMS Annual Meeting was investigated by comparing paired responses with "controversial questions" between pre- and postmeeting surveys in the matched population who either attended the 2016 NAMS Annual Meeting (intervention arm) or did not (control arm). "Controversial questions" were defined as those where 25% to 75% of responders answered "YES" to a question. McNemar's test was applied to analyze paired responses using SAS statistical software, with Pâ≤â0.05 being considered statistically significant. RESULTS: A total of 1,786 NAMS members were surveyed before and after the 2016 NAMS meeting, 234 (13%) completed the premeeting survey, 166 (9%) completed the postmeeting survey, and 52 completed both surveys. Of the 52, 27 attended the 2016 NAMS Annual Meeting and 25 did not. The pooled cohort contains 348 responses which represents a 20% response rate. Six complex case scenarios with "controversial questions" were identified from the pooled cohort and reexamined in the intervention and control arm, respectively. In the intervention arm, significant changes toward being more likely to prescribe HT in guideline-consistent cases were noted in four out of six cases, whereas significant changes in HT use were not seen in any of six complex cases in the control arm. CONCLUSIONS: NAMS members' prescribing patterns of HT vary in complex clinical scenarios. After the 2016 NAMS Annual Meeting where a draft of the 2017 NAMS HT Position Statement was presented and discussed, in four challenging and complex clinical situations a significant number of practitioners changed their prescription patterns toward prescribing HT which was consistent with the new guideline.
Assuntos
Atitude do Pessoal de Saúde , Terapia de Reposição Hormonal/métodos , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Estudos Controlados Antes e Depois , Estrogênios/uso terapêutico , Feminino , Terapia de Reposição Hormonal/estatística & dados numéricos , Humanos , Masculino , Menopausa/efeitos dos fármacos , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
Los médicos que atienden a mujeres menopáusicas están familiarizados con el sín- drome genitourinario de la menopausia (SGM), anteriormente conocido como atrofia vulvova- ginal, una afección progresiva que afecta la función sexual y la calidad de vida. Aunque la SGM afecta hasta al 45% de las mujeres de mediana edad y mayores, la mayoría de las personas con esta afección no se diagnostican ni se tratan.1
Assuntos
Pessoa de Meia-Idade , Menopausa , Administração Intravaginal , HormôniosRESUMO
OBJECTIVE: This post hoc analysis estimates time to transient and stable reductions in hot flush frequency in postmenopausal women using conjugated estrogens/bazedoxifene. METHODS: In the 12-week Selective estrogens, Menopause, And Response to Therapy (SMART)-2 trial of conjugated estrogens/bazedoxifene 0.45âmg/20âmg and 0.625âmg/20âmg, women with at least seven moderate/severe hot flushes per day or 50 per week at screening recorded frequency of moderate/severe hot flushes in diaries. Nonparametric models and SAS Proc Lifetest were used to estimate median times to various degrees of transient reductions (first day with improvement) and stable reductions (first day with improvement maintained through study's end) in hot flush frequency. RESULTS: Treatment produced transient hot flush reductions of 40% to 100% and stable reductions of 30% to 100% significantly faster than placebo. Median time to a transient 50% reduction was 8 days for conjugated estrogens/bazedoxifene 0.45âmg/20âmg, 9.5 for 0.625âmg/20âmg, and 10 for placebo; median time to a stable 50% reduction was 9, 10, and 38 days. Median time to a transient 90% reduction was 32 and 22.5 days for 0.45âmg/20âmg and 0.625âmg/20âmg, and median time to a stable 90% reduction was 83 and 29 days, respectively; median times to transient/stable 90% reductions were not reached during the 12-week study in the placebo group. CONCLUSIONS: Although not all women using conjugated estrogens/bazedoxifene achieve permanent elimination of hot flushes, the frequency is likely to be substantially reduced during the first week to month. Women can expect approximately 50% reduction in hot flush frequency after about 8 to 10 days, and sustained improvement with continued treatment.
Assuntos
Estrogênios Conjugados (USP)/uso terapêutico , Estrogênios , Fogachos/tratamento farmacológico , Indóis/uso terapêutico , Pós-Menopausa/fisiologia , Moduladores Seletivos de Receptor Estrogênico , Adulto , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Placebos , Fatores de TempoRESUMO
OBJECTIVE: Conjugated estrogens/bazedoxifene (CE/BZA) is indicated to treat moderate/severe menopausal vasomotor symptoms and prevent postmenopausal osteoporosis. This analysis examines the impact of the most bothersome vaginal symptom at baseline on effects of CE/BZA. METHODS: This post hoc analysis used data from a 12-week clinical trial of nonhysterectomized postmenopausal women (nâ=â664) randomly assigned to double-blind treatment with CE/BZA (0.45/20âmg and 0.625/20âmg), BZA 20âmg, or placebo. At baseline, women indicated which moderate/severe vaginal symptom (dryness, itching/irritation, or pain with intercourse) bothered them most. Repeated measures models were used to explore treatment effects in relationship to the most bothersome symptom. We calculated effect sizes for treatment differences versus placebo (effect sizes: trivial, 0.1; small, 0.2; medium, 0.5; large, 0.8). RESULTS: At baseline, 52% of women selected pain with intercourse, 35% selected vaginal dryness, and 13% selected vaginal itching/irritation as most bothersome. For these three symptom groups respectively, CE/BZA was associated with statistically significant improvements in Menopause-Specific Quality of Life sexual functioning (effect size: 0.45/20âmg, -0.36, -0.30, -0.67; 0.625/20âmg, -0.37, -0.40, -0.26) and/or overall score (effect size: 0.45/20âmg, -0.29, -0.41, -0.78; 0.625/20âmg, -0.41, -0.48, -0.68). Both those doses significantly improved the ease of lubrication item on the Arizona Sexual Experiences Scale in those with pain with intercourse (effect size: 0.45/20âmg, -0.43; 0.625/20âmg, -0.50) and produced some statistically significant improvements in vaginal cell counts in women with dryness or pain with intercourse as the most bothersome symptom. The higher dose was associated with greater treatment satisfaction on the Menopause Symptoms Treatment Satisfaction Questionnaire versus placebo in women who selected pain with intercourse (effect size: 0.40) or dryness (effect size: 0.43) as most bothersome. CONCLUSIONS: The approved dose of CE/BZA had clear benefits, particularly in women with pain with intercourse (the most common bothersome symptom), in whom it improved lubrication, superficial cell counts, and sexual functioning.
Assuntos
Estrogênios Conjugados (USP)/administração & dosagem , Indóis/administração & dosagem , Menopausa , Doenças Vaginais/tratamento farmacológico , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Pessoa de Meia-Idade , Dor Intratável/tratamento farmacológico , Inquéritos e Questionários , Resultado do TratamentoRESUMO
OBJECTIVE: This study characterizes and quantifies the relationship of vasomotor symptoms (VMS) of menopause with menopause-specific quality of life (MSQOL) and sleep parameters to help predict treatment outcomes and inform treatment decision-making. METHODS: Data were derived from a 12-week randomized, double-blind, placebo-controlled phase 3 trial that evaluated effects of two doses of conjugated estrogens/bazedoxifene on VMS in nonhysterectomized postmenopausal women (Nâ=â318, mean ageâ=â53.39) experiencing at least seven moderate to severe hot flushes (HFs) per day or at least 50 per week. Repeated measures models were used to determine relationships between HF frequency and severity and outcomes on the Menopause-Specific Quality of Life questionnaire and the Medical Outcomes Study sleep scale. Sensitivity analyses were performed to check assumptions of linearity between VMS and outcomes. RESULTS: Frequency and severity of HFs showed approximately linear relationships with MSQOL and sleep parameters. Sensitivity analyses supported assumptions of linearity. The largest changes associated with a reduction of five HFs and a 0.5-point decrease in severity occurred in the Menopause-Specific Quality of Life vasomotor functioning domain (0.78 for number of HFs and 0.98 for severity) and the Medical Outcomes Study sleep disturbance (7.38 and 4.86) and sleep adequacy (-5.60 and -4.66) domains and the two overall sleep problems indices (SPI: 5.17 and 3.63; SPII: 5.82 and 3.83). CONCLUSIONS: Frequency and severity of HFs have an approximately linear relationship with MSQOL and sleep parameters-that is, improvements in HFs are associated with improvements in MSQOL and sleep. Such relationships may enable clinicians to predict changes in sleep and MSQOL expected from various VMS treatments.
Assuntos
Estrogênios Conjugados (USP)/administração & dosagem , Fogachos/tratamento farmacológico , Indóis/administração & dosagem , Menopausa , Transtornos do Sono-Vigília/tratamento farmacológico , Técnicas de Apoio para a Decisão , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Fogachos/psicologia , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Transtornos do Sono-Vigília/psicologia , Resultado do Tratamento , Reino Unido , Estados UnidosRESUMO
OBJECTIVE: From a survey of compounding pharmacists, specific questions regarding compounded menopausal hormone therapy were used to estimate compounded hormone therapy (CHT) prescribing in the United States. METHODS: A national online survey was conducted by Rose Research--a market research company consisting of 12,250 US pharmacists from independent community pharmacies (ICPs) and compounding pharmacies (CPs). Pharmacists who completed the survey and met the prespecified criteria were eligible. Data from the survey were extrapolated to estimate overall CHT prescription volume and annual costs of CHT prescriptions for the United States based upon industry data from the National Community Pharmacists Association and IBISWorld. RESULTS: Surveys were completed by 483 pharmacies, including 365 ICPs and 118 CPs. On the basis of the survey responses and extrapolated industry data, an estimated 26 to 33 million CHT prescriptions were filled annually, with total sales estimated at $1.3 to $1.6 billion. CPs (vs ICPs) accounted for a higher proportion of CHT prescriptions. More than half of the ICPs (52%) and CPs (75%) expected continued compounding business growth, with most predicting 5% to 25% growth within 2 years, despite the potential effect of restrictive legislation regarding compounding. CONCLUSIONS: On the basis of extrapolated data from numbers of prescriptions reported by pharmacists participating in the survey, the volume of CHT seems to approach that of Food and Drug Administration (FDA)-approved menopausal hormone therapy, and growth in the CHT market is expected. Thus, physicians should educate themselves and the women consulting them about the differences between the FDA-approved and the less-tested CHT formulations. More research on the efficacy, safety, and consistency of non-FDA-approved CHT is needed.
Assuntos
Aprovação de Drogas/legislação & jurisprudência , Terapia de Reposição de Estrogênios , Menopausa , Medicamentos sob Prescrição , Inquéritos e Questionários , United States Food and Drug Administration/legislação & jurisprudência , Composição de Medicamentos , Indústria Farmacêutica/legislação & jurisprudência , Terapia de Reposição de Estrogênios/efeitos adversos , Terapia de Reposição de Estrogênios/métodos , Terapia de Reposição de Estrogênios/estatística & dados numéricos , Estrogênios , Feminino , Humanos , Internet , Farmacêuticos , Progestinas , Estados UnidosRESUMO
OBJECTIVE: Two surveys (Harris and Rose surveys) were conducted to quantify the use of compounded hormone therapy (CHT; or bioidentical hormone therapy) among perimenopausal and postmenopausal women in the United States, to assess women's knowledge of CHT versus Food and Drug Administration (FDA)-approved hormone therapy, and to gather information on menopausal experience. METHODS: The Harris survey was administered to 801 women aged 45 to 60 years who had experienced at least one menopausal symptom. The Rose survey was administered to 2,044 women aged 40 years or older who were ever users of hormone therapy. Women were queried about menopausal symptoms, hormone therapy use, and knowledge of CHT. Findings from the Rose survey were extrapolated using US Census Bureau data and prescription claims for FDA-approved hormone therapy to estimate the prevalence of CHT use. RESULTS: According to extrapolations using Rose data, up to 2.5 million US women aged 40 years or older may use CHT annually, accounting for 28% to 68% of hormone therapy prescriptions. Harris data showed that 86% of women surveyed were unaware that CHT products are not FDA-approved. The Rose survey asked a subset of 1,771 women whether their hormone therapy had been personalized based on hormone levels; 21% (378) answered "yes" whereas 27% (476) did not know. In both surveys, most hormone therapy users stated that their physician had recommended the treatment. CONCLUSIONS: We estimate that 1 million to 2.5 million US women aged 40 years or older use CHT. The data suggest that many women are unaware that compounded hormones have not been evaluated or approved by the FDA. Providers have an educational opportunity to ensure that women considering hormone therapy understand the risks and benefits of inadequately regulated CHT.
Assuntos
Terapia de Reposição de Estrogênios , Conhecimentos, Atitudes e Prática em Saúde , Menopausa , Adulto , Idoso , Idoso de 80 Anos ou mais , Aprovação de Drogas , Composição de Medicamentos , Feminino , Humanos , Pessoa de Meia-Idade , Inquéritos e Questionários , Estados Unidos , United States Food and Drug Administration , Saúde da MulherRESUMO
OBJECTIVE: Treatment of menopausal symptoms by compounds with tissue-selective estrogen agonist/antagonist effects, often called selective estrogen receptor modulators, has been researched as an alternative to the use of estrogen therapy. These structurally diverse molecules elicit tissue-dependent responses in hormone-responsive tissues and organs, exhibiting variations in estrogenic activity in preclinical models of postmenopausal reproductive tissues that may improve postmenopausal women's health (eg, prevention and treatment of breast cancer, osteoporosis, and vulvar and vaginal atrophy). METHODS: This literature review investigates whether preclinical data predicted the clinical effects of ospemifene on female reproductive and urinary tract tissues and compares these findings with the specific vaginal effects of other estrogen receptor agonists/antagonists (tamoxifen, raloxifene, and bazedoxifene) in preclinical and clinical studies. Lasofoxifene, although not currently available, is included because of its unique effects on vaginal tissue. RESULTS: The response of endometrial and vaginal tissues to estrogen receptor agonists/antagonists can be differentiated using transvaginal ultrasound, endometrial histopathology, cytologic examination of vaginal smears, assessment of physical changes in the vagina, and relief of symptoms associated with vulvar and vaginal atrophy (such as dyspareunia). CONCLUSIONS: Available evidence indicates that ospemifene has unique effects on tissue, leading to a favorable long-term profile for the relief of vulvar and vaginal atrophy compared with other estrogen receptor agonists/antagonists (eg, tamoxifen, raloxifene, and bazedoxifene) with no short-term concerns about endometrial safety (based on endometrial hyperplasia, carcinoma, endometrial spotting, and endometrial bleeding).
Assuntos
Antagonistas de Estrogênios/farmacologia , Menopausa/efeitos dos fármacos , Tamoxifeno/análogos & derivados , Pesquisa Translacional Biomédica , Sistema Urogenital/efeitos dos fármacos , Feminino , Doenças Urogenitais Femininas/tratamento farmacológico , Humanos , Tamoxifeno/farmacologiaRESUMO
OBJECTIVE: This study aims to confirm the factor structure of the Menopause-Specific Quality of Life (MENQOL) questionnaire by using confirmatory factor analysis (CFA) and to determine whether improvements in menopause-specific health-related quality of life (HRQOL) observed with bazedoxifene (BZA)/conjugated estrogens (CE) relative to placebo are clinically meaningful. METHODS: Postmenopausal women with seven or more moderate to severe hot flushes per day (or ≥50 per wk) received BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo for 12 weeks. HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire, respectively. The structure of the MENQOL questionnaire was evaluated using CFA. To estimate clinically important differences (CIDs) in HRQOL, we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors. RESULTS: The CFA model fits the MENQOL data (Bentler's comparative fit index >0.9). CID estimates ranged from 0.5 to 1.2 for the MENQOL domains and total score. Change from baseline in MENQOL vasomotor domain score for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg compared with placebo was greater than the estimated CID, as were changes in MENQOL physical domain and total scores for BZA 20 mg/CE 0.625 mg compared with placebo. CONCLUSIONS: CFA confirms the factor structure of the MENQOL questionnaire. Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms.
Assuntos
Estrogênios Conjugados (USP)/administração & dosagem , Fogachos/prevenção & controle , Menopausa/psicologia , Qualidade de Vida , Adulto , Idoso , Método Duplo-Cego , Feminino , Fogachos/psicologia , Humanos , Indóis/administração & dosagem , Pessoa de Meia-Idade , Moduladores Seletivos de Receptor Estrogênico/administração & dosagem , Inquéritos e Questionários , Resultado do TratamentoRESUMO
OBJECTIVE: Mediation modeling was used to evaluate the direct effects of bazedoxifene (BZA)/conjugated estrogens (CE) on sleep, compared with its indirect effects via improvements in hot flushes, in postmenopausal women enrolled in the SMART (Selective estrogens, Menopause, And Response to Therapy)-2 and SMART-5 trials. METHODS: Statistical mediation modeling estimated the direct effects of BZA/CE on sleep disturbance (Medical Outcomes Study sleep scale) and its indirect effects via hot flush improvement (item 1 of the Menopause-Specific Quality of Life questionnaire). In SMART-2, a total of 318 women with moderate to severe vasomotor symptoms (VMS) received BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo; in SMART-5, a total of 1,843 women seeking menopausal symptom treatment received BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, CE 0.45 mg/medroxyprogesterone acetate 1.5 mg, BZA 20 mg, or placebo. The SMART-5 sleep substudy enrolled 459 women with bothersome VMS and sleep disturbances. RESULTS: In SMART-2, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg had a primarily direct effect on sleep in symptomatic women (64% and 66%, respectively; P < 0.001). Conversely, in the overall SMART-5 population, effects were primarily indirect (82% and 75% for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg, respectively; P < 0.01), suggesting that sleep improvement was largely mediated via hot flush improvements. In a subpopulation of SMART-5 (participants with bothersome VMS), BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg affected sleep disturbance directly (82% and 76%, respectively; P < 0.0001). CONCLUSIONS: BZA/CE improves sleep in postmenopausal women with moderate to severe and milder VMS. This study suggests that improvements occur directly in women with moderate to severe VMS and indirectly in less symptomatic women.