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@article{Mohan:2023:10.1136/thorax-2021-218360,
author = {Mohan, D and Rossiter, H and Watz, H and Fogarty, C and Evans, RA and Man, W and Tabberer, M and Beerahee, M and Kumar, S and Millns, H and Thomas, S and Tal-Singer, R and Russell, AJ and Holland, MC and Akinseye, C and Neil, D and Polkey, M},
doi = {10.1136/thorax-2021-218360},
journal = {Thorax},
pages = {258--266},
title = {Selective androgen receptor modulation for muscle weakness in chronic obstructive pulmonary disease: a randomised control trial},
url = {http://dx.doi.org/10.1136/thorax-2021-218360},
volume = {78},
year = {2023}
}

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TY  - JOUR
AB  - Background Selective androgen receptor modulators (SARMs) increase muscle mass via the androgen receptor. This phase 2A trial investigated the effects of a SARM, GSK2881078, in conjunction with exercise, on leg strength in patients with chronic obstructive pulmonary disease (COPD) and impaired physical function.Methods 47 postmenopausal women and 50 men with COPD (forced expiratory volume in 1 s 30%–65% predicted; short physical performance battery score: 3–11) were enrolled into a randomised double-blind, placebo control trial. Patients were randomised 1:1 to once daily placebo or oral GSK2881078 (females: 1.0 mg; males: 2.0 mg) for 13 weeks with a concurrent home-exercise programme, involving strength training and physical activity. Primary endpoints were change from baseline in leg strength at 90 days (one-repetition maximum; absolute (kg) and relative (% change)) and multiple safety outcomes. Secondary endpoints included lean body mass, physical function and patient-reported outcomes.Results GSK2881078 increased leg strength in men. The difference in adjusted mean change from baseline and adjusted mean percentage change from baseline between treatment and placebo were: for women, 8.0 kg (90% CI −2.5 to 18.4) and 5.2% (90% CI −4.7 to 15.0), respectively; for men, 11.8 kg (90% CI −0.5 to 24.0) and 7.0% (90% CI 0.5 to 13.6), respectively. Lean body mass increased, but no changes in patient-reported outcomes were observed. Reversible reductions in high-density lipoprotein-cholesterol and transient elevations in hepatic transaminases were the main treatment-related safety findings.Conclusions GSK2881078 was well tolerated and short-term treatment increased leg strength, when expressed as per cent predicted, in men with COPD more than physical training alone.
AU  - Mohan,D
AU  - Rossiter,H
AU  - Watz,H
AU  - Fogarty,C
AU  - Evans,RA
AU  - Man,W
AU  - Tabberer,M
AU  - Beerahee,M
AU  - Kumar,S
AU  - Millns,H
AU  - Thomas,S
AU  - Tal-Singer,R
AU  - Russell,AJ
AU  - Holland,MC
AU  - Akinseye,C
AU  - Neil,D
AU  - Polkey,M
DO  - 10.1136/thorax-2021-218360
EP  - 266
PY  - 2023///
SN  - 0040-6376
SP  - 258
TI  - Selective androgen receptor modulation for muscle weakness in chronic obstructive pulmonary disease: a randomised control trial
T2  - Thorax
UR  - http://dx.doi.org/10.1136/thorax-2021-218360
UR  - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000874803500001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=a2bf6146997ec60c407a63945d4e92bb
UR  - https://thorax.bmj.com/content/78/3/258
UR  - http://hdl.handle.net/10044/1/107314
VL  - 78
ER  -

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