BACKGROUND: : Duavive® (conjugated estrogens with bazedoxifene) has been authorized in the EU since 2014 for the treatment of estrogen deficiency symptoms in postmenopausal women for whom treatment with progestin-containing therapy is not appropriate. This drug utilization study was designed to collect real-world data on use of Duavive and was a commitment to the European Medicines Agency.
OBJECTIVES: To describe 1) characteristics of EU patients initiating treatment with either Duavive or oestrogen + progestin hormone replacement therapy (E+P HRT) and 2) Duavive utilization patterns.
METHODS: A non-interventional retrospective study was conducted using existing data sources in 6 EU countries (electronic medical Records in France, Italy, Spain, UK; longitudinal prescription and cross-sectional databases in Belgium and the Netherlands) from March2016 to March 2019. Age ≤45 was used as a proxy for premenopausal status in the analysis of potential off-label use.
RESULTS: The numbers of Duavive initiators/ E+P HRT users in the longitudinal databases 3 years after Duavive launch were 11/ 29,799 in the UK, 22/ 29,047 in France, 73/ 2,573 in Spain, 177/ 76,550 in the Netherlands, 223/ 6,288 in Italy and 480/ 57,059 in Belgium. The majority of Duavive users were aged ≥50 years, ranging from 55%(UK) to 93% (Belgium); the range for E+P HRT users ≥50 years was42% (Spain) to 91% (Belgium). Oestrogen deficiency symptoms were recorded in 49% (Spain) to 91% (Belgium) of Duavive users. Potential off-label use of Duavive ranged from 9% (France) to 29% (Spain) of patients ts and was primarily comprised of use in women ≤45 years of age. These women may have been postmenopausal and using Duavivein accordance with the label indication. Other evidence for potential off-label use included diagnostic codes for osteoporosis (0% in Belgium and France to 5% in Italy and Spain), hypersensitivity (1% in Italy and Spain), concomitant prescriptions of selective estrogen receptor modulators (SERMs; 2% and 7% in Belgium and the Netherlands), prescription of a non-approved dose (2% in Italy and the Netherlands),and malignancy related to oestrogens (<1% in Italy and 1% in Spain).In Belgium and in the Netherlands 4% and 5% of patients (respectively) were >75 years of age; 3% of patients in Belgium, 1% in the Netherlands and <1% in Italy were documented as male.
CONCLUSIONS: Overall, Duavive was prescribed to the indicated population and at the dosage recommended in the Summary of Product Characteristics.
