Maturitas最新文献

{"title":"Exploring the experiences of adult patients with turner syndrome at a multidisciplinary clinic","authors":"Sooyoun Shin ,&nbsp;Laurel Liang ,&nbsp;Clara Korenvain ,&nbsp;Lisa M. McCarthy ,&nbsp;Iliana C. Lega","doi":"10.1016/j.maturitas.2025.108214","DOIUrl":"10.1016/j.maturitas.2025.108214","url":null,"abstract":"<div><h3>Objective</h3><div>To explore the experiences of adults with Turner syndrome 1) attending a multidisciplinary Turner syndrome clinic regarding reproductive and general health; and 2) interacting with a multidisciplinary team for the management of their Turner syndrome.</div></div><div><h3>Study design</h3><div>In this descriptive, qualitative study, 21 adults with Turner syndrome who attend a multidisciplinary Turner syndrome clinic participated in semi-structured interviews. An inductive approach was used to code data and determine themes.</div></div><div><h3>Results</h3><div>Five themes were identified. 1) <em>Differing feelings toward fertility status</em>. Experiences with fertility differed widely, based on timing and communication of diagnosis, and feelings toward having children. 2) <em>Adaptability and overcoming challenges</em>. Participants sought ways to adapt to living with Turner syndrome. 3) <em>Engagement in one's own care</em>. Participants were engaged in their care and sought support in learning about their condition, especially around reproductive health. 4) <em>Desire for comprehensive healthcare</em>. Participants felt the multidisciplinary Turner syndrome clinic provided knowledgeable, convenient, and comprehensive care. 5) <em>Barriers to accessing healthcare</em>. Participants identified challenges both in accessing healthcare providers with expertise in Turner syndrome and in navigating the financial impact of Turner syndrome.</div></div><div><h3>Conclusion</h3><div>Infertility had differing impacts on adults with Turner syndrome. Participants were satisfied with the multidisciplinary care model. Our findings highlight the importance of multidisciplinary care for optimizing the experience of adults with Turner syndrome.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"195 ","pages":"Article 108214"},"PeriodicalIF":3.9,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143437927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Self-care experiences and behaviors in people with osteoporosis: A meta-synthesis","authors":"Chiara Tedesco ,&nbsp;Vicente Bernalte-Martí ,&nbsp;Gianluca Pucciarelli ,&nbsp;Ercole Vellone ,&nbsp;Emanuela Basilici Zannetti ,&nbsp;Noemi Cittadini ,&nbsp;Annalisa Pennini ,&nbsp;Umberto Tarantino ,&nbsp;Rosaria Alvaro","doi":"10.1016/j.maturitas.2025.108213","DOIUrl":"10.1016/j.maturitas.2025.108213","url":null,"abstract":"<div><div>Osteoporosis is a chronic systemic skeletal disease that can benefit from patient-led self-care behaviors. The purpose of this meta-synthesis is to summarize the knowledge about the experiences in self-care behaviors, according to Riegel's middle-range theory of self-care, of patients affected by osteoporosis. A systematic review of the literature and a meta-synthesis of the results were performed to identify qualitative and mixed-method studies through database research conducted on six databases until June 2023 that identified 27 articles. Three dimensions of self-care were recognized within the articles: ‘maintenance’ was the most reported, mostly associated with therapy adherence; ‘monitoring’, predominantly related to instrumental test; and, ‘management’, mainly related to the management of symptoms. A cross-cutting topic that emerges and has been shown to be relevant is that of the relationship with health professionals.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"195 ","pages":"Article 108213"},"PeriodicalIF":3.9,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143333393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Wearable devices, ischemic heart disease and cardiovascular outcomes: A systematic review and meta-analysis","authors":"Julia M.A. Ballavenuto,&nbsp;Nisachon Tongtip,&nbsp;Nina L.S. Fischer,&nbsp;Marco Bardus","doi":"10.1016/j.maturitas.2024.108186","DOIUrl":"10.1016/j.maturitas.2024.108186","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the impact of wearable devices when associated with usual care on the incidence of major adverse cardiovascular events (MACE) in patients with ischemic heart disease compared with usual care alone.</div></div><div><h3>Methods</h3><div>Randomised clinical trials with patients aged 18 years and above with ischemic heart disease, using wearable devices and assessing at least one of the primary outcomes (myocardial infarction, stroke, cardiovascular mortality, or major adverse cardiovascular events) or secondary outcomes (all-cause mortality, hospitalisation, all arrhythmias, heart failure, unstable angina or revascularisation procedures) were included. MEDLINE, EMBASE, Cochrane Library, CINHAL, INAHTA and the Web of Science Core Collection were searched in April 2024. Studies were also identified via citation searching. Cochrane Risk of Bias version 1 was applied as provided in Covidence. Meta-analyses were performed when possible.</div></div><div><h3>Results</h3><div>Six studies of moderate quality were included. Wearables showed positive effects in reducing major adverse cardiovascular events (RR 0.75, 95 % CI 0.57–0.98, two studies) and all-cause mortality (RR 0.64, 95 % CI 0.43–0.96, three studies); no significant effects were found on myocardial infarction (RR 0.89, 95 % CI 0.59–1.34, four studies), cardiovascular mortality (RR 0.35, 95 % CI 0.07–1.73, three studies), hospitalisations (RR 0.77, 95 % CI 0.56–1.07, five studies), all arrhythmias (RR 1.10, 95 % CI 0.49–2.48, two studies), and heart failure (RR 0.85, 95 % CI 0.61–1.18, two studies). Meta-analysis could not be performed for stroke, unstable angina, and revascularisation procedures. Grading of Recommendations Assessment, Development and Evaluation (GRADE) certainty of evidence was deemed low or very low.</div></div><div><h3>Discussion</h3><div>While wearables seem to have some positive effects for patients with ischemic heart disease, only weak recommendations for use are possible. More large-scale, high-quality randomised clinical trials are needed to recommend the routine use of wearables in combination with usual care.</div></div><div><h3>Protocol registration on PROSPERO</h3><div>CRD42024586137</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108186"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142901536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding Parkinson's: The microbiome and machine learning approach","authors":"David Rojas-Velazquez ,&nbsp;Sarah Kidwai ,&nbsp;Ting Chia Liu ,&nbsp;Mounim A. El-Yacoubi ,&nbsp;Johan Garssen ,&nbsp;Alberto Tonda ,&nbsp;Alejandro Lopez-Rincon","doi":"10.1016/j.maturitas.2024.108185","DOIUrl":"10.1016/j.maturitas.2024.108185","url":null,"abstract":"<div><h3>Objective</h3><div>Given that Parkinson's disease is a progressive disorder, with symptoms that worsen over time, our goal is to enhance the diagnosis of Parkinson's disease by utilizing machine learning techniques and microbiome analysis. The primary objective is to identify specific microbiome signatures that can reproducibly differentiate patients with Parkinson's disease from healthy controls.</div></div><div><h3>Methods</h3><div>We used four Parkinson-related datasets from the NCBI repository, focusing on stool samples. Then, we applied a DADA2-based script for amplicon sequence processing and the Recursive Ensemble Feature Selection (REF) algorithm for biomarker discovery. The discovery dataset was PRJEB14674, while PRJNA742875, PRJEB27564, and PRJNA594156 served as testing datasets. The Extra Trees classifier was used to validate the selected features.</div></div><div><h3>Results</h3><div>The Recursive Ensemble Feature Selection algorithm identified 84 features (Amplicon Sequence Variants) from the discovery dataset, achieving an accuracy of over 80%. The Extra Trees classifier demonstrated good diagnostic accuracy with an area under the receiver operating characteristic curve of 0.74. In the testing phase, the classifier achieved areas under the receiver operating characteristic curves of 0.64, 0.71, and 0.62 for the respective datasets, indicating sufficient to good diagnostic accuracy. The study identified several bacterial taxa associated with Parkinson's disease, such as Lactobacillus, Bifidobacterium, and Roseburia, which were increased in patients with the disease.</div></div><div><h3>Conclusion</h3><div>This study successfully identified microbiome signatures that can differentiate patients with Parkinson's disease from healthy controls across different datasets. These findings highlight the potential of integrating machine learning and microbiome analysis for the diagnosis of Parkinson's disease. However, further research is needed to validate these microbiome signatures and to explore their therapeutic implications in developing targeted treatments and diagnostics for Parkinson's disease.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108185"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142911406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Obstructive sleep apnea syndrome (OSAS) in women: A forgotten cardiovascular risk factor","authors":"Federica Moscucci ,&nbsp;Valentina Bucciarelli ,&nbsp;Sabina Gallina ,&nbsp;Susanna Sciomer ,&nbsp;Anna Vittoria Mattioli ,&nbsp;Silvia Maffei ,&nbsp;Savina Nodari ,&nbsp;Roberto Pedrinelli ,&nbsp;Paola Andreozzi ,&nbsp;Stefania Basili","doi":"10.1016/j.maturitas.2024.108170","DOIUrl":"10.1016/j.maturitas.2024.108170","url":null,"abstract":"<div><div>Sleep-disordered breathing is a highly prevalent disorder with negative impact on healthcare systems worldwide. This condition has detrimental effects on cardiovascular health and quality of life, and is frequently associated with a variety of comorbidities, including cardiovascular disease, heart failure, diabetes and atrial fibrillation. Nevertheless, it remains frequently undiagnosed and undertreated, especially in specific populations. Studies on sleep-disordered breathing have been conducted mainly on male patients, and the prevalence and severity of this disorder in women are underestimated. Recently, some clinical and laboratory evidence has highlighted the epidemiological and pathophysiological differences between men and women with sleep-disordered breathing. In this review, we discuss sex-related mechanisms of sleep-disordered breathing in frequently associated disorders, to improve clinical understanding of this condition and to simplify the practical application of targeted interventions. The aim is to improve prognosis among female patients and guarantee a better quality of life and a reduction in healthcare costs.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108170"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations between low sex steroid concentrations and incidence of knee and hip replacement for osteoarthritis in community-dwelling older women","authors":"Mengjie Zeng ,&nbsp;Susan R. Davis ,&nbsp;Flavia M. Cicuttini ,&nbsp;Angus Franks ,&nbsp;John J. McNeil ,&nbsp;Yuanyuan Wang","doi":"10.1016/j.maturitas.2024.108174","DOIUrl":"10.1016/j.maturitas.2024.108174","url":null,"abstract":"<div><h3>Objective</h3><div>To examine whether low circulating sex steroid concentrations are associated with the incidence of knee and hip replacement for osteoarthritis in community-dwelling older women.</div></div><div><h3>Study design</h3><div>This prospective cohort study examined 5535 Australian women recruited into the Aspirin in Reducing Events in the Elderly (ASPREE) trial, aged ≥70 years, not taking medications affecting sex steroid concentrations, and with sex steroid concentrations measured by liquid chromatography-tandem mass spectrometry.</div></div><div><h3>Main outcome measures</h3><div>The incidence of knee and hip replacement for osteoarthritis was determined by hospitalisations for knee and hip surgical procedures where osteoarthritis was recorded as the indication.</div></div><div><h3>Results</h3><div>With a mean follow-up of 3.9 (SD 1.4) years, 311 women underwent knee replacement and 242 underwent hip replacement. A greater incidence of knee replacement was observed in women with the lowest quartile concentrations of oestrone (HR 1.35, 95 % CI 1.04–1.75, p = 0.03) and testosterone (HR 1.35, 95 % CI 1.05–1.72, p = 0.02) compared with quartiles 2 to 4, after adjusting for age, body mass index, socioeconomic status, smoking, alcohol consumption, and comorbidities. A greater likelihood of hip replacement was seen for women with the lowest quartile concentrations of dehydroepiandrosterone compared with quartiles 2 to 4 (HR 1.37, 95 % CI 1.03–1.82, p = 0.03).</div></div><div><h3>Conclusions</h3><div>Low concentrations of endogenous sex steroids were associated with a greater likelihood of lower-limb joint replacement for osteoarthritis in community-based women aged 70 years or older. These findings suggest sex steroids contribute to musculoskeletal health in later life, although the mechanisms by which sex steroids might influence joint replacement remain unclear.</div><div>Clinicaltrials.gov <span><span>NCT01038583</span><svg><path></path></svg></span>.</div><div>International Standard Randomized Controlled Trial Number Register ISRCTN83772183.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108174"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142857401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploration of factors affecting denosumab-induced hypocalcemia in male patients with osteoporosis using a hospital-based administrative claims database","authors":"Yuto Kamimura,&nbsp;Keisuke Ikegami,&nbsp;Hayato Kizaki,&nbsp;Shungo Imai,&nbsp;Satoko Hori","doi":"10.1016/j.maturitas.2024.108190","DOIUrl":"10.1016/j.maturitas.2024.108190","url":null,"abstract":"<div><h3>Objectives</h3><div>Factors affecting denosumab-induced hypocalcemia in male patients with osteoporosis remain unclear because of the small patient population. Nevertheless, it is important to explore male-specific risk factors. This study aimed to identify the factors affecting the development of denosumab-induced hypocalcemia in male patients with osteoporosis and compare them with those in female patients with osteoporosis.</div></div><div><h3>Study design</h3><div>This retrospective, observational study used data from a hospital-based administrative claims database. Patients with osteoporosis undergoing denosumab treatment between April 2008 and May 2020 were enrolled. Data on age, inpatient/outpatient status, laboratory data, drug use, and disease status were collected.</div></div><div><h3>Main outcome measures</h3><div>Patients were classified as those with hypocalcemia and without hypocalcemia, and variables with <em>P</em> &lt; 0.2 and missing proportions &lt;30 % on univariate analysis were entered into multivariate logistic regression analysis. The multiple imputation method was used to compensate for missing data.</div></div><div><h3>Results</h3><div>Overall, 175 males and 1335 females were included in the analysis, and hypocalcemia developed in 52 and 247 patients, respectively. In the multivariate analysis, prior use of preventive medicine (calcium supplements or activated vitamin D) decreased the risk of osteoporosis only in male patients. Low corrected levels of calcium and albumin and low estimated glomerular filtration rates increased the risk in both sexes.</div></div><div><h3>Conclusions</h3><div>Prior use of preventive medicine may be a factor that decreases the risk of denosumab-induced hypocalcemia in male patients. Low corrected levels of calcium and albumin, and low estimated glomerular filtration rates are common risk factors in both male and female patients.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108190"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of menopause on circulating amino acid concentrations in women with fibromyalgia and healthy women","authors":"Alma Rus ,&nbsp;Bárbara Coca-Guzmán ,&nbsp;Francisco Molina ,&nbsp;María Correa-Rodríguez ,&nbsp;José Manuel Martínez-Martos ,&nbsp;María Jesús Ramírez-Expósito ,&nbsp;María Encarnación Aguilar-Ferrándiz","doi":"10.1016/j.maturitas.2024.108171","DOIUrl":"10.1016/j.maturitas.2024.108171","url":null,"abstract":"<div><h3>Objectives</h3><div>Fibromyalgia is a complex syndrome that appears more frequently during menopause. No previous studies have investigated the effect of menopause on amino acids in women with fibromyalgia. Therefore, we have examined serum amino acid concentrations in premenopausal and postmenopausal women with fibromyalgia and healthy women.</div></div><div><h3>Study design</h3><div>A case-control study was carried out in 28 premenopausal and 46 postmenopausal healthy women and in 16 premenopausal and 52 postmenopausal women with fibromyalgia. This study adheres to STROBE guidelines.</div></div><div><h3>Main outcome measures</h3><div>Amino acid content was assayed using high-performance liquid chromatography.</div></div><div><h3>Results</h3><div>Significant differences were found in concentrations of several amino acids (aspartic acid, glutamic acid, histidine, glycine, alanine, leucine, and taurine) between healthy premenopausal women and premenopausal women with fibromyalgia and between healthy postmenopausal women and postmenopausal women with fibromyalgia. Concentrations of other amino acids (aminoadipic acid, asparagine, threonine, arginine, 5-methyl-histidine, valine, methionine, isoleucine, phenylalanine, ornithine, branched-chain amino acids, large neutral amino acids, essential amino acids, non-essential amino acids, basic amino acids, and arginine/ornithine ratio) were found to differ between healthy postmenopausal women and postmenopausal women with fibromyalgia, but not between healthy premenopausal women and premenopausal women with fibromyalgia. No significant differences were found in serum amino acid concentrations between premenopausal and postmenopausal healthy women or between premenopausal and postmenopausal women with fibromyalgia.</div></div><div><h3>Conclusions</h3><div>Our results show, for the first time, that the association between menopause and fibromyalgia may increase the risk of metabolic disorders by disrupting amino acid homeostasis to a greater extent than menopause or fibromyalgia alone.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108171"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex-specific associations of neurodegeneration and inflammatory biomarkers with intrinsic capacity in older adults: Findings from the 4-year longitudinal Multidomain Alzheimer's Prevention Trial (MAPT)","authors":"Luana Caroline de Assunção Cortez Corrêa ,&nbsp;Jérémy Raffin ,&nbsp;Bruno Vellas ,&nbsp;Ricardo Oliveira Guerra ,&nbsp;Philipe de Souto Barreto","doi":"10.1016/j.maturitas.2024.108191","DOIUrl":"10.1016/j.maturitas.2024.108191","url":null,"abstract":"<div><div>This four-year longitudinal study investigated whether the cross-sectional and longitudinal associations of inflammation-related and neurodegenerative-related blood biomarkers with intrinsic capacity differ according to sex. The sample comprised 1117 older adults (&lt;70 years, 63.8 % females) from the Multidomain Alzheimer's Prevention Trial (MAPT). The domains of intrinsic capacity were operationalized as cognition (Mini-Mental State Examination), locomotion (Short Physical Performance Battery), vitality (Handgrip Strength), and psychological well-being (Geriatric Depression Scale), each scaled from 0 (worst intrinsic capacity possible) to 100 (best intrinsic capacity possible). Plasma biomarkers included interleukin 6 (picograms per milliliter), growth differentiation factor-15 (picograms per milliliter), tumor necrosis factor receptor 1 (picograms per milliliter), neurofilament light chain (picograms per milliliter), progranulin (nanograms per milliliter), and amyloid-beta ratio. Linear mixed models were analyzed to examine whether sex modified the cross-sectional and longitudinal association between biomarkers and intrinsic capacity. No significant interaction effect was observed at baseline. Longitudinal analyses revealed a significant interaction between sex and interleukin 6 (p = .005), such that higher levels of interleukin 6 tended to be associated with a faster decline in intrinsic capacity for males (B = −0.385; p = .055; 95 % CI = −0.778; 0.008) but not for females (B = 0.287; p = .041; 95 % CI = 0.011; 0.563). The other biomarkers had no sex-dependent associations with intrinsic capacity. A potential sex-dependent effect of the inflammatory status on intrinsic capacity must be further investigated.</div><div>Clinical trial registration with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT00672685</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108191"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142928268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of fezolinetant on patient-reported quality-of-life outcomes: Data from a phase 3b study (DAYLIGHT) of the treatment of moderate to severe vasomotor symptoms associated with menopause in women considered unsuitable for hormone therapy","authors":"Marla Shapiro C.M. ,&nbsp;Xi Wu ,&nbsp;Xuegong Wang ,&nbsp;Kentaro Miyazaki ,&nbsp;Antonia Morga ,&nbsp;Rossella E. Nappi ,&nbsp;Petra Stute ,&nbsp;Karla Martins ,&nbsp;Katrin Schaudig","doi":"10.1016/j.maturitas.2024.108159","DOIUrl":"10.1016/j.maturitas.2024.108159","url":null,"abstract":"<div><h3>Objective</h3><div>To report patient-reported quality-of-life (QOL) outcomes in the DAYLIGHT study.</div></div><div><h3>Study design</h3><div>DAYLIGHT was a phase 3b, randomized, double-blind, 24-week, placebo-controlled study. Participants were women aged ≥40 to ≤65 years with moderate to severe vasomotor symptoms (VMS) considered unsuitable for hormone therapy (HT) (contraindications, caution, stoppers, or averse) randomized 1:1 to placebo or fezolinetant 45 mg once daily.</div></div><div><h3>Main outcome measures</h3><div>Primary endpoint: mean change in daily VMS frequency of moderate to severe episodes from baseline to week 24. Secondary: patient-reported sleep disturbance (PROMIS SD SF 8b). Exploratory: patient-reported sleep disturbance (Patient Global Impression of Severity/Change in Sleep Disturbance [PGI-S/PGI-C SD]), menopause and VMS-related QOL (Female Sexual Function Index [FSFI], Menopause-Specific Quality of Life [MENQOL], Patient Global Impression of Change in Vasomotor Symptoms [PGI-C VMS], Work Productivity and Activity Impairment questionnaire specific to VMS [WPAI-VMS]), and general QOL (European Quality of Life 5 Dimensions 5 Level Version [EQ-5D-5L], Patient Health Questionnaire for Anxiety and Depression [PHQ-4]).</div></div><div><h3>Results</h3><div>Overall, 452 women received at least one dose of study drug (placebo <em>n</em> = 226; fezolinetant <em>n</em> = 226): HT contraindicated (50; 11 %), caution (165; 37 %), stoppers (69; 15 %), and averse (168; 37 %). DAYLIGHT results showed statistically significant reductions in VMS frequency/severity in the fezolinetant group versus placebo at week 24. Week 24 improvements were seen in the fezolinetant group versus placebo in: PROMIS SD SF 8b total score (least squares [LS] mean difference: −2.5; 95 % CI: −3.9, −1.1; <em>p</em> &lt; 0.001), MENQOL total score (LS mean difference: −0.44; 95 % CI: −0.69, −0.18; <em>p</em> &lt; 0.001), and WPAI-VMS (activity impairment [<em>p</em> &lt; 0.001], overall work productivity loss [<em>p</em> = 0.036], and presenteeism [<em>p</em> = 0.002] domains). A higher proportion of participants in the fezolinetant group reported positive changes in sleep disturbance (PGI-C SD, <em>p</em> &lt; 0.001), sleep disturbance severity (PGI-S SD, <em>p</em> = 0.042), and VMS (PGI-C VMS, <em>p</em> &lt; 0.001) versus placebo.</div></div><div><h3>Conclusions</h3><div>Patient-reported outcomes demonstrate that reductions in VMS frequency with fezolinetant treatment were associated with improvements in QOL.</div></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":"193 ","pages":"Article 108159"},"PeriodicalIF":3.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}