AI Article Synopsis
- The phase 2b VESTA study found that oral fezolinetant significantly reduced the frequency and severity of menopausal vasomotor symptoms (VMS) compared to a placebo.
- In a 12-week double-blind trial with 356 postmenopausal women, those taking various doses of fezolinetant showed better responder rates and improvements in patient-reported outcomes (PROs) related to quality of life.
- The results indicated that fezolinetant yielded significantly greater improvements in measures like the Menopause-Specific Quality of Life questionnaire and Hot Flash-Related Daily Interference Scale, surpassing the minimally important differences (MIDs) at both 4 and 12 weeks.
Article Abstract
Objective: In the primary analysis of the phase 2b VESTA study, oral fezolinetant reduced frequency and severity of menopausal vasomotor symptoms (VMS) compared with placebo. This secondary analysis evaluates effects of fezolinetant on responder rates and patient-reported outcomes (PROs).
Methods: In this 12-week, double-blind study, postmenopausal women with moderate/severe VMS were randomized to fezolinetant 15, 30, 60, or 90 mg BID or 30, 60, or 120 mg QD or placebo. Proportion of responders was based on reductions in VMS from daily diary records. P values for comparisons between active treatment and placebo were calculated using logistic regression. Changes from baseline in PROs (Menopause-Specific Quality of Life questionnaire, Hot Flash-Related Daily Interference Scale, Greene Climacteric Scale) were conducted using a mixed model for repeated measurements and compared post hoc with published minimally important differences (MIDs).
Results: Of 356 women randomized, 352 were treated and analyzed. A greater proportion of women receiving fezolinetant versus placebo met definitions of response at week 12. For all doses, mean changes from baseline in Menopause-Specific Quality of Life questionnaire VMS scores exceeded the MID (1.2) at weeks 4 (placebo: -1.8; fezolinetant: range, -1.9 to -3.6) and 12 (placebo: -2.3; fezolinetant: range, -2.9 to -4.4). Mean changes in Hot Flash-Related Daily Interference Scale at weeks 4 (placebo: -2.2; fezolinetant: range, -2.5 to -3.8) and 12 (placebo: -2.9; fezolinetant: range, -3.3 to -4.3) exceeded the MID (1.76). Greene Climacteric Scale-VMS domain scores improved for most fezolinetant doses versus placebo (week 4, placebo: -1.7; fezolinetant: range, -2.1 to -3.3; week 12, placebo: -2.1; fezolinetant: range, -2.7 to -3.6).
Conclusions: Oral fezolinetant was associated with higher responder rates than placebo and larger improvements in QoL and other PRO measures, including a reduction in VMS-related interference with daily life.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7709922 | PMC |
| http://dx.doi.org/10.1097/GME.0000000000001621 | DOI Listing |
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OGEDA SA, subsidiary of Astellas Pharma, Inc., Gosselies, Belgium.
Article Synopsis
- The phase 2b VESTA study found that oral fezolinetant significantly reduced the frequency and severity of menopausal vasomotor symptoms (VMS) compared to a placebo.
- In a 12-week double-blind trial with 356 postmenopausal women, those taking various doses of fezolinetant showed better responder rates and improvements in patient-reported outcomes (PROs) related to quality of life.
- The results indicated that fezolinetant yielded significantly greater improvements in measures like the Menopause-Specific Quality of Life questionnaire and Hot Flash-Related Daily Interference Scale, surpassing the minimally important differences (MIDs) at both 4 and 12 weeks.
A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause.
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OGEDA SA, a wholly owned subsidiary of Astellas Pharma SA, Belgium.
Article Synopsis
- The study aimed to evaluate fezolinetant, a non-hormone treatment targeting neurokinin 3 receptors, for alleviating menopausal vasomotor symptoms (VMS) in women aged 40-65 with moderate to severe symptoms.
- Participants were randomly assigned to different dosing regimens of fezolinetant or a placebo for 12 weeks, with the main outcomes being the frequency and severity of VMS episodes.
- Results showed significant reductions in VMS frequency and severity for those taking fezolinetant compared to placebo, with a high percentage of participants achieving a 50% reduction in symptoms, and the treatment was generally well-tolerated.
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