Abstract
Background
The purpose of this study was to quantify the impact of estradiol-valerate/dienogest (E2V/DNG; Qlaira®/Natazia®) on work productivity and activities of daily living in European and Australian women with heavy menstrual bleeding.
Methods
Women aged 18–54 years with a confirmed diagnosis of heavy menstrual bleeding and no recognizable pathology were recruited across nine European countries (the Czech Republic, Finland, Germany, Hungary, The Netherlands, Poland, Sweden, UK, and Ukraine) and Australia. The women were randomized to receive either E2V/DNG (n = 149) or placebo (n = 82) for seven treatment cycles (196 days). The outcomes assessed included work productivity (ie, productivity while at work) and activities of daily living, measured on a Likert scale from 0 to 10 (with higher values denoting higher impairment levels) at baseline and at the end of the third and seventh cycles (days 84 and 196). The equivalent monetary value associated with the changes in work productivity and activities of daily living was also calculated.
Results
Across all the countries, greater improvements from baseline to the end of treatment were observed with E2V/DNG treatment than placebo in work productivity (46.0% versus 15.1%) and activities of daily living (55.6% versus 30.8%). In 2008, savings associated with improvements in work productivity and activities of daily living due to E2V/DNG treatment (net of placebo improvement) were estimated to be between US$22–62 and US$18–56 per month (in purchasing power parity of US$), respectively.
Conclusion
E2V/DNG has a consistent positive impact on work productivity and activities of daily living in European and Australian women with heavy menstrual bleeding. These improvements were associated with a reduction in monetary burden of heavy menstrual bleeding compared with the placebo group, consistent with the response to treatment observed.
Disclosure
This study was funded by Bayer HealthCare Pharmaceuticals, Berlin, Germany, the manufacturer of E2V/DNG. Editorial assistance with the preparation of this manuscript was provided by Richard Glover of inScience Communications, Springer Healthcare. Funding for this editorial assistance was provided by Bayer HealthCare Pharmaceuticals. RW, DS, and SS are employees of United BioSource Corporation which was contracted to perform the analysis. DJV is contracted to United BioSource Corporation. IF is a consultant and speaker for Bayer HealthCare Pharmaceuticals, Schering Plough, and Daiichi Sankyo Pharmaceuticals, and has received research support from the National Institutes of Health, the Australian National Health and Medical Research Council, the Population Council, Bayer HealthCare Pharmaceuticals, and Schering Plough. AF and KW-J are current employees of Bayer HealthCare Pharmaceuticals.