Key clinical point: Hormone therapy with Duavee®, containing conjugated estrogens ( 0.45 mg ) and bazedoxifene ( 20 mg ), yielded a favorable study retention and treatment satisfaction in menopausal women with multiple sclerosis (MS).
Major finding: Patients receiving Duavee® vs. placebo had a fewer missed doses (median, interquartile range [IQR] 0 [0-0] vs. 1 [0-9]), a greater Global Satisfaction on the Treatment Satisfaction Questionnaire for Medication (median, IQR 65.9 [52.8-100] vs. 62.5 [11.1-93.0]), and lesser side effects (20% vs. 13%), with none of the patients reporting a clinical relapse.
Study details: Findings are from a double-blind phase 1b/2a trial involving 21 peri/postmenopausal women with MS who were randomly assigned to parallel groups of Duavee® or equivalent placebo for 8 weeks.
Disclosures: This study was funded the National Multiple Sclerosis Society pilot grant and CTSI grant. Some authors declared receiving research support, personal compensation, speaker fees, or nonfinancial support from various sources, including Wyeth/Pfizer, the manufacturer of Duavee ®. Several authors are provisional patent holders for the use of bazedoxifene in remyelination therapy.
Source: Bove R et al. A hormonal therapy for menopausal women with MS: A phase Ib/IIa randomized controlled trial. Mult Scler Relat Disord. 2022;67:103747 (Mar 19). Doi: 10.1016/j.msard.2022.103747