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Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial

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Harvard

Rooks, D, Swan, T, Goswami, B, Filosa, LA, Bunte, O, Panchaud, N, Coleman, LA, Miller, RR, Garcia Garayoa, E, Praestgaard, J, Perry, RG, Recknor, C, Fogarty, CM, Arai, H, Chen, L-K, Hashimoto, J, Chung, Y-S, Vissing, J, Laurent, D, Petricoul, O, Hemsley, S, Lach-Trifilieff, E, Papanicolaou, DA & 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, pp. e2020836. https://doi.org/10.1001/jamanetworkopen.2020.20836

APA

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., ... 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, 3(10), e2020836. https://doi.org/10.1001/jamanetworkopen.2020.20836

CBE

Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen L-K, Hashimoto J, Chung Y-S, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, 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. 3(10):e2020836. https://doi.org/10.1001/jamanetworkopen.2020.20836

MLA

Vancouver

Author

Rooks, Daniel ; Swan, Therese ; Goswami, Budhaditya ; Filosa, Lee Anne ; Bunte, Ola ; Panchaud, Nicolas ; Coleman, Laura A ; Miller, Ram R ; Garcia Garayoa, Elisa ; Praestgaard, Jens ; Perry, Robert G ; Recknor, Chris ; Fogarty, Charles M ; Arai, Hidenori ; Chen, Liang-Kung ; Hashimoto, Jun ; Chung, Yoon-Sok ; Vissing, John ; Laurent, Didier ; Petricoul, Olivier ; Hemsley, Sarah ; Lach-Trifilieff, Estelle ; Papanicolaou, Dimitris A ; Roubenoff, Ronenn. / Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults : A Randomized Clinical Trial. In: JAMA network open. 2020 ; Vol. 3, No. 10. pp. e2020836.

Bibtex

@article{d6bacd05b0ba4e7ea67be21b61f339f4,
title = "Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial",
abstract = "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 < .001). Conclusions and Relevance: This randomized clinical trial found no significant difference between participants treated with bimagrumab vs placebo among older adults with sarcopenia who had 6 months of adequate nutrition and light exercise, with physical function improving in both groups. Bimagrumab treatment was safe, well-tolerated, increased lean body mass, and decreased fat body mass. The effects of sarcopenia, an increasing cause of disability in older adults, can be reduced with proper diet and exercise. Trial Registration: ClinicalTrials.gov Identifier: NCT02333331; EudraCT number: 2014-003482-25.",
author = "Daniel Rooks and Therese Swan and Budhaditya Goswami and Filosa, {Lee Anne} and Ola Bunte and Nicolas Panchaud and Coleman, {Laura A} and Miller, {Ram R} and {Garcia Garayoa}, Elisa and Jens Praestgaard and Perry, {Robert G} and Chris Recknor and Fogarty, {Charles M} and Hidenori Arai and Liang-Kung Chen and Jun Hashimoto and Yoon-Sok Chung and John Vissing and Didier Laurent and Olivier Petricoul and Sarah Hemsley and Estelle Lach-Trifilieff and Papanicolaou, {Dimitris A} and Ronenn Roubenoff",
year = "2020",
month = oct,
day = "1",
doi = "10.1001/jamanetworkopen.2020.20836",
language = "English",
volume = "3",
pages = "e2020836",
journal = "JAMA network open",
issn = "2574-3805",
publisher = "American Medical Association",
number = "10",

}

RIS

TY - JOUR

T1 - Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults

T2 - A Randomized Clinical Trial

AU - Rooks, Daniel

AU - Swan, Therese

AU - Goswami, Budhaditya

AU - Filosa, Lee Anne

AU - Bunte, Ola

AU - Panchaud, Nicolas

AU - Coleman, Laura A

AU - Miller, Ram R

AU - Garcia Garayoa, Elisa

AU - Praestgaard, Jens

AU - Perry, Robert G

AU - Recknor, Chris

AU - Fogarty, Charles M

AU - Arai, Hidenori

AU - Chen, Liang-Kung

AU - Hashimoto, Jun

AU - Chung, Yoon-Sok

AU - Vissing, John

AU - Laurent, Didier

AU - Petricoul, Olivier

AU - Hemsley, Sarah

AU - Lach-Trifilieff, Estelle

AU - Papanicolaou, Dimitris A

AU - Roubenoff, Ronenn

PY - 2020/10/1

Y1 - 2020/10/1

N2 - 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 < .001). Conclusions and Relevance: This randomized clinical trial found no significant difference between participants treated with bimagrumab vs placebo among older adults with sarcopenia who had 6 months of adequate nutrition and light exercise, with physical function improving in both groups. Bimagrumab treatment was safe, well-tolerated, increased lean body mass, and decreased fat body mass. The effects of sarcopenia, an increasing cause of disability in older adults, can be reduced with proper diet and exercise. Trial Registration: ClinicalTrials.gov Identifier: NCT02333331; EudraCT number: 2014-003482-25.

AB - 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 < .001). Conclusions and Relevance: This randomized clinical trial found no significant difference between participants treated with bimagrumab vs placebo among older adults with sarcopenia who had 6 months of adequate nutrition and light exercise, with physical function improving in both groups. Bimagrumab treatment was safe, well-tolerated, increased lean body mass, and decreased fat body mass. The effects of sarcopenia, an increasing cause of disability in older adults, can be reduced with proper diet and exercise. Trial Registration: ClinicalTrials.gov Identifier: NCT02333331; EudraCT number: 2014-003482-25.

UR - http://www.scopus.com/inward/record.url?scp=85093986933&partnerID=8YFLogxK

U2 - 10.1001/jamanetworkopen.2020.20836

DO - 10.1001/jamanetworkopen.2020.20836

M3 - Journal article

C2 - 33074327

VL - 3

SP - e2020836

JO - JAMA network open

JF - JAMA network open

SN - 2574-3805

IS - 10

ER -

ID: 61071805