0.5 vs. 1.0 mg estradiol in combination with drospirenone for the treatment of hot flushes. (August 2015) - Gerlinger, C.
Abstract Objective To compare the efficacy of 0.5 and 1.0 mg estradiol in combination with different doses of drospirenone for the treatment of menopausal hot flushes. Methods This retrospective analysis included data from two prospective, randomized, double-blind, multicenter, placebo-controlled studies. Inclusion criteria were seven to eight moderate to severe hot flushes per day during the 1-week screening period. The focus was the rate of responders. A responder was defined as a subject that had at least a perceptible improvement of 19.1 hot flushes per week at 4 weeks and a substantial improvement of 40.3 hot flushes per week at 12 weeks compared to baseline. Secondary focus was the absolute change of moderate to severe hot flushes per week over 12 weeks. Results A total of 832 subjects were included. At baseline, the median weekly number of moderate to severe hot flushes was between 62 and 67. After 12 weeks of treatment, combinations of 0.5 and 1 mg estradiol achieved a median reduction of 54–55 and 57–64 moderate to severe hot flushes, respectively. In the 0.5-mg estradiol group, the responder rates for combinations with drospirenone 0.25 and 0.5 mg were 62.7% and 75.8%, respectively. In the 1-mg estradiol group, the responder rates for combinations with drospirenone 1, 2 and 3 mg were 86.7%, 100% and 89.7%, respectively. Conclusion Effective relief from hot flushes can be reached within 12 weeks with estradiol doses of 0.5 and 1 mg in combination with different drospirenone doses.