Systematic Reviews/Meta-Analysis
Saturday, November 11, 2023
11:30 AM–01:00 PM
Abstract
Background:
Vasomotor symptoms (VMS) affect many postmenopausal persons and impact sleep and quality of life. This systematic review examines the safety and efficacy of non-hormonal selective neurokinin-3 receptor (NK3R) antagonists approved and in development for persons with VMS.
Methods: A search of Medline and Embase was conducted using the search terms and permutations of NK3R antagonist, elinzanetant, fezolinetant, and osanetant. Inclusion criteria were: reporting on efficacy or safety of fezolinetant, elinzanetant, or osanetant; studies in participants identifying as female; full record in English; and, primary literature. Abstract-only records were excluded. Extracted data were synthesized to allow comparison of reported study characteristics, efficacy outcomes, and safety events. Eligible records were evaluated for risk of bias (ROB) via the Cochrane Risk of Bias 2 tool for randomized studies and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used.
Results: The search returned 191 records; 186 were screened after deduplication. Inclusion criteria was met by five randomized controlled trials (RCTs), three reported on fezolinetant and two reported on elinzanetant. One record was a post-hoc analysis of a fezolinetant RCT. The three fezolinetant RCTs demonstrated a reduction in VMS frequency/severity, improvement in Menopause-Specific Quality of Life (MENQoL) scores, and improvement in sleep quality at weeks 4 and 12 compared to placebo without serious adverse events. The two RCTs on elinzanetant also showed improvements in VMS frequency and severity. All six records evaluated safety through treatment-emergent adverse events; the most common adverse events were headache, somnolence, and gastrointestinal. Each record evaluated had a low ROB. There is a strong certainty of evidence as per the GRADE system.
Discussion: Due to the high-quality evidence supporting the efficacy of fezolinetant and elinzanetant, these agents may be an effective option with mild adverse events for patients seeking nonhormonal treatment of VMS.
Other: This study was neither funded nor registered.
Presenting Author
Elaine Marji PharmD CandidateUniversity at Buffalo
Authors
Timothy Hutcherson PharmD
D'Youville College
Nicole Cieri-Hutcherson PharmD, BCPS, NCMP
University at Buffalo School of Pharmacy and Pharmaceutical Sciences