{"title":"Therapeutics for Sarcopenia and Functional Disabilities in Older Adults: A Review of Phase 4 Clinical Trials.","authors":"Nasser M Alorfi, Fahad S Alshehri, Ahmed M Ashour","doi":"10.2147/DDDT.S507033","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Sarcopenia significantly contributes to physical disability and reduced quality of life in older adults, leading to disability. Therapeutics used to manage sarcopenia can improve not only muscle health but also the overall functional capacity of individuals at risk of developing disabilities. This review focuses on the therapeutic interventions evaluated in phase 4 clinical trials to address sarcopenia and its associated disabilities in older adults.</p><p><strong>Objective: </strong>To review and summarize the therapeutic agents tested in phase 4 clinical trials for the management of sarcopenia and their potential impact on reducing functional disabilities in older adults.</p><p><strong>Methods: </strong>A review of phase 4 clinical trials was conducted on 6<sup>th</sup> November 2024, focusing on interventions for sarcopenia in older adults. Data on therapeutic agents, trial outcomes, and their effects on muscle mass, strength, and disability prevention were collected from clinicaltrials.gov database.</p><p><strong>Results: </strong>Several therapeutic agents, including whey protein powder, eldecalcitol, testosterone enanthate, and Denosumab, have been tested in Phase 4 trials for their ability to enhance muscle mass and function in older adults with sarcopenia. Allopurinol and Pioglitazone were also studied for their potential to improve muscle metabolism, while Medrol (Methylprednisolone) and Levothyroxine offered supportive effects in inflammatory and metabolic disorders that exacerbate muscle loss. Moreover, combination therapies, such as nutritional supplementation with HMB and vitamin D, showed promise in improving muscle function. These interventions demonstrated varying degrees of efficacy in improving muscle strength, reducing physical disability, and enhancing overall functional capacity in older adults.</p><p><strong>Conclusion: </strong>Therapeutic strategies targeting sarcopenia in older adults have the potential to reduce functional disabilities and improve quality of life. Phase 4 clinical trials provide valuable insights into the long-term safety and effectiveness of these treatments. Continued research and refinement of these therapies are essential to fully address the disabling effects of sarcopenia and promote healthy aging.</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"2307-2314"},"PeriodicalIF":4.7000,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956726/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S507033","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Sarcopenia significantly contributes to physical disability and reduced quality of life in older adults, leading to disability. Therapeutics used to manage sarcopenia can improve not only muscle health but also the overall functional capacity of individuals at risk of developing disabilities. This review focuses on the therapeutic interventions evaluated in phase 4 clinical trials to address sarcopenia and its associated disabilities in older adults.
Objective: To review and summarize the therapeutic agents tested in phase 4 clinical trials for the management of sarcopenia and their potential impact on reducing functional disabilities in older adults.
Methods: A review of phase 4 clinical trials was conducted on 6th November 2024, focusing on interventions for sarcopenia in older adults. Data on therapeutic agents, trial outcomes, and their effects on muscle mass, strength, and disability prevention were collected from clinicaltrials.gov database.
Results: Several therapeutic agents, including whey protein powder, eldecalcitol, testosterone enanthate, and Denosumab, have been tested in Phase 4 trials for their ability to enhance muscle mass and function in older adults with sarcopenia. Allopurinol and Pioglitazone were also studied for their potential to improve muscle metabolism, while Medrol (Methylprednisolone) and Levothyroxine offered supportive effects in inflammatory and metabolic disorders that exacerbate muscle loss. Moreover, combination therapies, such as nutritional supplementation with HMB and vitamin D, showed promise in improving muscle function. These interventions demonstrated varying degrees of efficacy in improving muscle strength, reducing physical disability, and enhancing overall functional capacity in older adults.
Conclusion: Therapeutic strategies targeting sarcopenia in older adults have the potential to reduce functional disabilities and improve quality of life. Phase 4 clinical trials provide valuable insights into the long-term safety and effectiveness of these treatments. Continued research and refinement of these therapies are essential to fully address the disabling effects of sarcopenia and promote healthy aging.
期刊介绍：
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
Drug target identification and validation
Phenotypic screening and target deconvolution
Biochemical analyses of drug targets and their pathways
New methods or relevant applications in molecular/drug design and computer-aided drug discovery*
Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes)
Structural or molecular biological studies elucidating molecular recognition processes
Fragment-based drug discovery
Pharmaceutical/red biotechnology
Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products**
Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development
Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing)
Preclinical development studies
Translational animal models
Mechanisms of action and signalling pathways
Toxicology
Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.
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