Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults:A Randomized Clinical Trial
| Autor: | Jens Praestgaard, Liang Kung Chen, Hidenori Arai, Olivier Petricoul, Budhaditya Goswami, Dimitris Papanicolaou, John Vissing, Yoon Sok Chung, Chris Recknor, Estelle Lach-Trifilieff, Jun Hashimoto, Laura A. Coleman, Nicolas Panchaud, Ram R. Miller, Lee Anne Filosa, Didier Laurent, Robert G. Perry, Sarah Hemsley, Charles M. Fogarty, Ola Bunte, Ronenn Roubenoff, Daniel Rooks, Therese Swan, Elisa Garcia Garayoa |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Sarcopenia
medicine.medical_specialty Standard of care Physical function Antibodies Monoclonal Humanized Placebo law.invention Double-Blind Method Randomized controlled trial law Internal medicine Humans Medicine Bimagrumab Aged Original Investigation Aged 80 and over business.industry Light Exercise Standard of Care General Medicine medicine.disease Combined Modality Therapy Exercise Therapy Motor Skills Disorders Treatment Outcome Dietary Supplements Quality of Life Lean body mass Accidental Falls Female Independent Living business |
| Zdroj: | Rooks, D, Swan, T, Goswami, B, Filosa, L A, Bunte, O, Panchaud, N, Coleman, L A, Miller, R R, Garcia Garayoa, E, Praestgaard, J, Perry, R G, Recknor, C, Fogarty, C M, Arai, H, Chen, L K, Hashimoto, J, Chung, Y S, Vissing, J, Laurent, D, Petricoul, O, Hemsley, S, Lach-Trifilieff, E, Papanicolaou, D A & Roubenoff, R 2020, ' Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults : A Randomized Clinical Trial ', JAMA Network Open, vol. 3, no. 10, e2020836 . https://doi.org/10.1001/jamanetworkopen.2020.20836 JAMA Netw Open |
| Popis: | Importance: The potential benefit of novel skeletal muscle anabolic agents to improve physical function in people with sarcopenia and other muscle wasting diseases is unknown. Objective: To confirm the safety and efficacy of bimagrumab plus the new standard of care on skeletal muscle mass, strength, and physical function compared with standard of care alone in community-dwelling older adults with sarcopenia. Design, Setting, and Participants: This double-blind, placebo-controlled, randomized clinical trial was conducted at 38 sites in 13 countries among community-dwelling men and women aged 70 years and older meeting gait speed and skeletal muscle criteria for sarcopenia. The study was conducted from December 2014 to June 2018, and analyses were conducted from August to November 2018. Interventions: Bimagrumab 700 mg or placebo monthly for 6 months with adequate diet and home-based exercise. Main Outcomes and Measures: The primary outcome was the change in Short Physical Performance Battery (SPPB) score after 24 weeks of treatment. Secondary outcomes included 6-minute walk distance, usual gait speed, handgrip strength, lean body mass, fat body mass, and standard safety parameters. Results: A total of 180 participants were recruited, with 113 randomized to bimagrumab and 67 randomized to placebo. Among these, 159 participants (88.3%; mean [SD] age, 79.1 [5.3] years; 109 [60.6%] women) completed the study. The mean SPPB score increased by a mean of 1.34 (95% CI, 0.90 to 1.77) with bimagrumab vs 1.03 (95% CI, 0.53 to 1.52) with placebo (P = .13); 6-minute walk distance increased by a mean of 24.60 (95% CI, 7.65 to 41.56) m with bimagrumab vs 14.30 (95% CI, -4.64 to 33.23) m with placebo (P = .16); and gait speed increased by a mean of 0.14 (95% CI, 0.09 to 0.18) m/s with bimagrumab vs 0.11 (95% CI, 0.05 to 0.16) m/s with placebo (P = .16). Bimagrumab was safe and well-tolerated and increased lean body mass by 7% (95% CI, 6% to 8%) vs 1% (95% CI, 0% to 2%) with placebo, resulting in difference of 6% (95% CI, 4% to 7%) (P |
| Databáze: | OpenAIRE |
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