Oral estradiol/micronized progesterone may be associated with lower risk of venous thromboembolism compared with conjugated equine estrogens/medroxyprogesterone acetate in real-world practice.

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 17β-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

Development of a questionnaire on sexual quality of life in women

The Sexual Quality of Life-Female (SQOL-F) questionnaire has been developed to assess the impact of female sexual dysfunction (FSD) on a woman's sexual quality of life. SQOL-F items were developed through interviews with 82 women. Three data sets from women's health surveys in the United Kingdom and the United States generated data for scale validation. The SQOL-F showed good psychometric properties: convergent validity, discriminant validity, and test-retest reliability. The SQOL-F is a valid instrument for assessing the impact of FSD on quality of life and as an adjunct in evaluating FSD in clinical trials. The SQOL-F sensitivity to changes in sexual function needs confirmation

Development of a sexual function questionnaire for clinical trials of female sexual dysfunction

OBJECTIVE: To better evaluate efficacy in clinical trials of drugs as potential treatments for female sexual dysfunctions (FSD), a brief, multidimensional measure of female sexual function was developed. METHODS: Data from semistructured interviews with 82 women with or without FSD, aged 19-65 years, generated a pool of 61 items that addressed aspects of female sexual function. On review by a panel, individual items were selected for face validity and clinical relevance. Thirty-one items were used as a sexual function questionnaire (SFQ-V1) in two multicenter, phase II clinical trials totaling 781 women with FSD. Normative data were generated from a sample of 201 women without FSD. RESULTS: Factor analysis produced seven domains of female sexual function: desire, physical arousal-sensation, physical arousal-lubrication, enjoyment, orgasm, pain, and partner relationship. The internal consistency of the domains ranged from 0.65 to 0.91, and test-retest reliability ranged from 0.21 to 0.71 for Cohen's weighted kappa and 0.42 to 0.78 for Pearson's correlation coefficient. There was a significant difference between the baseline mean SFQ domain scores of patients with FSD compared with those of women without FSD (p < 0.0001). End-of-study SFQ scores were significantly different for women who reported improvement vs. women who reported no improvement (p < 0.001). CONCLUSIONS: The SFQ produced seven domains of female sexual function with excellent internal consistency, moderate to good reliability, excellent discriminant validity, and sensitivity. The results suggest that the SFQ may be a valuable new tool for evaluating and diagnosing subsets of FSD and, ultimately, for evaluating treatments of these disorder

Fracture risk in women with osteoporosis initiated on gastro-resistant risedronate versus immediate release risedronate or alendronate: A claims data analysis in the USA

Summary: The study results indicate that women with osteoporosis initiated on gastro-resistant risedronate have a lower risk of fracture than those initiated on immediate release risedronate or alendronate. A large proportion of women discontinued all oral bisphosphonate therapies within 1 year of treatment start. Purpose: Using a US claims database (2009–2019), we compared risk of fractures between women with osteoporosis initiated on gastro-resistant (GR) risedronate and those initiated on (a) immediate release (IR) risedronate or (b) immediate release alendronate. Methods: Women aged ≥ 60 years with osteoporosis who had ≥ 2 oral bisphosphonate prescription fills were followed for ≥ 1 year after the first observed bisphosphonates dispensing (index date). Fracture risk was compared between the GR risedronate and IR risedronate/alendronate cohorts using adjusted incidence rate ratios (aIRRs), both overall and in subgroups with high fracture risk due to older age or comorbidity/medications. Site-specific fractures were identified based on diagnosis codes recorded on medical claims using a claims-based algorithm. Persistence on bisphosphonate therapy was evaluated for all groups. Results: aIRRs generally indicated lower fracture risk for GR risedronate than IR risedronate and alendronate. When comparing GR risedronate to IR risedronate, statistically significant aIRRs (p\u3c0.05) were observed for pelvic fractures in the full cohorts (aIRRs=0.37), for any fracture and pelvic fractures among women aged≥65 years (aIRRs=0.63 and 0.41), for any fracture and pelvic fractures among women aged≥70 years (aIRRs=0.69 and 0.24), and for pelvic fracture among high-risk women due to comorbidity/medications (aIRR=0.34). When comparing GR risedronate to alendronate, statistically signifcant aIRRs were observed for pelvic fractures in the full cohorts (aIRR=0.54), for any fracture and wrist/arm fractures among women aged≥65 years (aIRRs=0.73 and 0.63), and for any fracture, pelvic, and wrist/arm fractures among women aged≥70 years (aIRRs=0.72, 0.36, and 0.58). In all cohorts, ~40% completely discontinued oral bisphosphonates within 1 year. Conclusions Discontinuation rates of oral bisphosphonate therapy were high. However, women initiated on GR risedronate had a signifcantly lower risk of fracture for several skeletal sites than women initiated on IR risedronate/alendronate, particularly those aged≥70 years.\u3e \u3c 0.05) were observed for pelvic fractures in the full cohorts (aIRRs=0.37), for any fracture and pelvic fractures among women aged ≥ 65 years (aIRRs=0.63 and 0.41), for any fracture and pelvic fractures among women aged ≥ 70 years (aIRRs=0.69 and 0.24), and for pelvic fracture among high-risk women due to comorbidity/medications (aIRR=0.34). When comparing GR risedronate to alendronate, statistically significant aIRRs were observed for pelvic fractures in the full cohorts (aIRR=0.54), for any fracture and wrist/arm fractures among women aged ≥ 65 years (aIRRs=0.73 and 0.63), and for any fracture, pelvic, and wrist/arm fractures among women aged ≥ 70 years (aIRRs=0.72, 0.36, and 0.58). In all cohorts, ~40% completely discontinued oral bisphosphonates within 1 year. Conclusions: Discontinuation rates of oral bisphosphonate therapy were high. However, women initiated on GR risedronate had a significantly lower risk of fracture for several skeletal sites than women initiated on IR risedronate/alendronate, particularly those aged ≥ 70 years