MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture: A multicenter, randomized, placebo-controlled phase IIb study
| Autor: | Nancy Liu, Dimitris Papanicolaou, Boyd B. Scott, Norman Heyden, Jeannine Lutkiewicz, Yuliya Berd, Abraham Adunsky, Julie Chandler |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Aging medicine.medical_specialty Indoles Health (social science) Placebo law.invention Double-Blind Method Randomized controlled trial law Humans Medicine Spiro Compounds Muscle Strength Prospective Studies Range of Motion Articular Prospective cohort study Physical Therapy Modalities Aged Aged 80 and over Fracture Healing Hip fracture Dose-Response Relationship Drug Hip Fractures business.industry Recovery of Function Middle Aged medicine.disease Confidence interval Surgery Clinical trial Treatment Outcome Lower Extremity Heart failure Anesthesia Female Geriatrics and Gerontology business Range of motion Gerontology Follow-Up Studies |
| Zdroj: | Archives of Gerontology and Geriatrics. 53:183-189 |
| ISSN: | 0167-4943 |
| Popis: | 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 25mg/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 25mg/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. |
| Databáze: | OpenAIRE |
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