TY - JOUR
T1 - MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture
T2 - A multicenter, randomized, placebo-controlled phase IIb study
AU - Adunsky, Abraham
AU - Chandler, Julie
AU - Heyden, Norman
AU - Lutkiewicz, Jeannine
AU - Scott, Boyd B.
AU - Berd, Yuliya
AU - Liu, Nancy
AU - Papanicolaou, Dimitris A.
PY - 2011/9
Y1 - 2011/9
N2 - Most elderly patients admitted for hip fracture suffer functional decline. Previous studies with MK-0677 in hip fracture patients suggested possible benefits to functional recovery. This is a randomized, double-blind study of 123 elderly hip fracture patients assigned to receive 25. mg/day of MK-0677 (n= 62) or placebo (n= 61). Primary outcomes were a rank analysis of change during the study in objective functional performance measurements and insulin-like growth factor-1 (IGF-1) levels in blood. At 24-weeks, the mean stair climbing power increased by 12.5 W in the MK-0677 group (95% confidence interval (CI) = -10.95-35.88; p= 0.292) compared with placebo. Gait speed increased by a 0.7-score difference in the means (95% CI = 0.17-1.28; p= 0.011). There was no improvement in MK-0677 treated patients in several other functional performance measures. The MK-0677 group experienced fewer falls during the study compared to placebo and smaller number of patients who had any falls (p= 0.096). Levels of IGF-1 in treated patients increased by 51.4. ng/ml (95% CI = 34.42-68.44; p< 0.001) compared to placebo. Trial was terminated early due to a safety signal of congestive heart failure in a limited number of patients. In hip fracture patients treated with 25. mg/day MK-0677, the increase in plasma IGF-1 levels was not paralleled by improvement in most functional performance measures. MK-0677 has an unfavorable safety profile in this patient population.
AB - Most elderly patients admitted for hip fracture suffer functional decline. Previous studies with MK-0677 in hip fracture patients suggested possible benefits to functional recovery. This is a randomized, double-blind study of 123 elderly hip fracture patients assigned to receive 25. mg/day of MK-0677 (n= 62) or placebo (n= 61). Primary outcomes were a rank analysis of change during the study in objective functional performance measurements and insulin-like growth factor-1 (IGF-1) levels in blood. At 24-weeks, the mean stair climbing power increased by 12.5 W in the MK-0677 group (95% confidence interval (CI) = -10.95-35.88; p= 0.292) compared with placebo. Gait speed increased by a 0.7-score difference in the means (95% CI = 0.17-1.28; p= 0.011). There was no improvement in MK-0677 treated patients in several other functional performance measures. The MK-0677 group experienced fewer falls during the study compared to placebo and smaller number of patients who had any falls (p= 0.096). Levels of IGF-1 in treated patients increased by 51.4. ng/ml (95% CI = 34.42-68.44; p< 0.001) compared to placebo. Trial was terminated early due to a safety signal of congestive heart failure in a limited number of patients. In hip fracture patients treated with 25. mg/day MK-0677, the increase in plasma IGF-1 levels was not paralleled by improvement in most functional performance measures. MK-0677 has an unfavorable safety profile in this patient population.
KW - Disability
KW - Ghrelin receptor
KW - Growth hormone
KW - Hip fracture
KW - IGF-1
KW - Sarcopenia
UR - http://www.scopus.com/inward/record.url?scp=79960083206&partnerID=8YFLogxK
U2 - 10.1016/j.archger.2010.10.004
DO - 10.1016/j.archger.2010.10.004
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AN - SCOPUS:79960083206
SN - 0167-4943
VL - 53
SP - 183
EP - 189
JO - Archives of Gerontology and Geriatrics
JF - Archives of Gerontology and Geriatrics
IS - 2
ER -