Evidence map›Paper›PMID 38115258›Full record

SynthesisMedicine2023

Efficacy and safety of fezolinetant, a neurokinin-3 antagonist, in treating vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis.

Ummi Aiman Rahman, Talha Bin Kashif, Muhammad Usman, Maham Rana, Muhammad Hasanain, Muhammad Umair Anjum, Huzaifa Ahmad Cheema, Huda Jaffar, Pratik Bhattarai

Open access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 5 countries.

Ummi Aiman RahmanDepartment of Medicine, King Edward Medical University, Lahore, Pakistan.
Talha Bin KashifDepartment of Medicine, King Edward Medical University, Lahore, Pakistan.
Muhammad UsmanDepartment of Medicine, Dow Medical College, Dow University of Health Sciences, Karachi, Pakistan.
Maham RanaDepartment of Medicine, Dow Medical College, Dow University of Health Sciences, Karachi, Pakistan.
Muhammad HasanainDepartment of Medicine, Dow Medical College, Dow University of Health Sciences, Karachi, Pakistan.
Muhammad Umair AnjumDepartment of Medicine, Dow Medical College, Dow University of Health Sciences, Karachi, Pakistan.
Huzaifa Ahmad CheemaDepartment of Medicine, King Edward Medical University, Lahore, Pakistan.
Huda JaffarDepartment of Medicine, Dow Medical College, Dow University of Health Sciences, Karachi, Pakistan.
Pratik BhattaraiDepartment of Medicine, Manipal College of Medical Sciences, Pokhara, Nepal.ORCID 0000-0002-9223-7800
Weatherford College · USKing Edward Medical University · PKManipal College of Medical Sciences · NP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMenopause causes a variety of symptoms such as hot flashes and night sweats. While menopausal hormonal therapy has been used for managing postmenopausal vasomotor symptoms (VMS) for quite a while, it has a considerably poor safety profile.

objectiveTo review and analyze existing data to evaluate the efficacy of the neurokinin-3 antagonist, fezolinetant, in treating postmenopausal VMS and to assess its safety profile.

methodsA thorough literature search was performed on PubMed, Cochrane Library, and Google Scholar in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020, to find publications on the efficacy of fezolinetant for postmenopausal VMS. Changes in the frequency and severity scores of moderate/severe VMS and changes in the Hot Flash-Related Daily Interference Scale (HFRDIS), Greene Climacteric Scale (GCS), and Menopause-Specific Quality of Life (MENQoL) were the efficacy outcomes. Adverse events, drug-related treatment-emergent adverse effects (TEAEs), drug-related dropouts, hepatotoxicity, endometrial hyperplasia or tumor, and uterine bleeding were all safety outcomes. We used Review Manager 5.4 for pooling risk ratios (RRs) and mean differences (MDs) for dichotomous and continuous outcomes, respectively. A P value of < .05 was considered significant.

resultsThere was a significant reduction in mean daily VMS frequency at weeks 4 and 12 (MD, -2.36; 95% confidence interval [CI], -2.85 to -1.87; P < .00001, for week 12) and also a significant decrease in VMS severity scores in the treatment group. Furthermore, improvements in MENQoL, HFRDIS, and GCS scores were observed. There was no significant difference in adverse events while drug-related TEAEs (RR, 1.21; 95% CI, 0.90-1.63; P = .21) showed a slight increase with fezolinetant. Drug-related dropouts were again similar across the 2 groups. Uterine bleeding had a lower incidence while endometrial events and hepatotoxicity showed a statistically insignificant, increasing trend in the fezolinetant group. DISCUSSION AND IMPLICATIONS: Fezolinetant can be a treatment option for postmenopausal VMS but warns of a risk increase in endometrial hyperplasia or tumors. The heterogeneity in the data being analyzed, short follow-up period, and small sample size in most of the included randomized controlled trials were the greatest limitations, which must be considered in further research and safety profile exploration.

Indexed as

Chemical and Drug Induced Liver InjuryEndometrial HyperplasiaFemaleHeterocyclic Compounds, 2-RingHot FlashesHumansMenopausePostmenopauseQuality of LifeThiadiazolesUterine HemorrhagefezolinetantHeterocyclic Compounds, 2-RingThiadiazoles

Identifiers

PMID38115258
PMCPMC10727556
OpenAlexW4389775170

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.