MK-677: Merck's ibutamoren raised IGF-1 in hip-fracture patients, but the trial was stopped over heart failure

Source: Adunsky et al., Archives of Gerontology and Geriatrics 53(2):183-9, 2011 (Merck-sponsored)

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“MK-0677 has an unfavorable safety profile in this patient population.”

Evidence level

Human randomized, double-blind, placebo-controlled phase 2b trial (123 elderly hip-fracture patients).

Funding

Industry: Merck program (MK-0677); several authors were Merck staff.

What was published

A trial of 25 mg/day MK-0677 (ibutamoren) versus placebo for up to 24 weeks after hip fracture.

What it shows

IGF-1 rose by 51.4 ng/ml versus placebo; gait speed improved (p = 0.011) and there were fewer falls (p = 0.096, not significant).

What it does not show

Most functional measures did not improve; "the increase in plasma IGF-1 levels was not paralleled by improvement in most functional performance measures."

Documented counterpoints

The trial "was terminated early due to a safety signal of congestive heart failure" (reported elsewhere as 4 of 62 vs 1 of 61). Frail elderly patients; results may differ in younger users.

Source link

Arch Gerontol Geriatr, DOI

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