Impact of estradiol valerate/dienogest (E 2V/DNG) on work productivity (WP) and activities of daily living (ADL) impairment in North American women with heavy and/or prolonged menstrual bleeding (HPMB)

Abstract

OBJECTIVE: To estimate the impact of HPMB on WP and ADL impairment and improvements in these outcomes during E2V/DNG treatment over 7 cycles. DESIGN: This was a post-hoc analysis of patient-reported outcomes collected in a randomized, placebo-controlled trial conducted in the USA/Canada (Jensen JT, et al. Fertil Steril 2009;92(3):S32 [abstr. O-107]) that evaluated the efficacy of E2V/DNG in women with HPMB. The primary endpoint was a responder analysis that included reductions in menstrual blood loss (MBL). The response rate was significantly higher in E2V/DNG versus placebo recipients. MBL was reduced by –353.1 and –130.4 mL in E2V/DNG and placebo recipients, respectively, over a 90-day efficacy interval. MATERIALS AND METHODS: Data were collected using a modified Work Productivity and Activities Impairment (mWPAI) questionnaire. WP and ADL were measured at baseline and at treatment end (EOT) using a 10-point Likert scale (higher values=higher impairment). Analyses were done using frequentist and Bayesian multivariate regression. RESULTS: E2V/DNG had a positive impact on WP and ADL impairment.Tabled 1Mean mWPAI scale (SD)Difference E2V/DNG–placeboChange from baselineWP impairmentUSABaseline4.1 (.2)EOTPlacebo3.6 (.4)–13.1%E2V/DNG2.2 (.2)–38.1%–46.2%CanadaBaseline4.0 (.5)EOTPlacebo3.3 (.5)–16.1%E2V/DNG2.1 (.3)–37.2%–47.3%ADL impairmentUSABaseline5.1 (.2)EOTPlacebo3.8 (.4)–24.8%E2V/DNG2.4 (.2)–37.6%–53.0%CanadaBaseline4.6 (.5)EOTPlacebo3.3 (.5)–28.0%E2V/DNG2.0 (.2)–39.2%–56.2%According to the WPAI scoring manual and average salaries in the USA/Canada, E2V/DNG was associated with monthly per-person savings of US$80.20/CA$70.80 (WP) and US$84.90/CA$73.50 (ADL). Open table in a new tab According to the WPAI scoring manual and average salaries in the USA/Canada, E2V/DNG was associated with monthly per-person savings of US$80.20/CA$70.80 (WP) and US$84.90/CA$73.50 (ADL). CONCLUSION: As well as resolving clinical HPMB symptoms, E2V/DNG has a substantial positive effect on patient-reported outcomes. At EOT, E2V/DNG recipients showed a strong reduction in WP and ADL impairment versus baseline that was greater than that in placebo recipients.