The same 1-year ibutamoren trial reported increased fasting glucose (+0.3 mmol/L, P=0.015) and reduced insulin sensitivity, together with increased appetite, mild lower-extremity edema and muscle pain as the most frequent side effects. A separate, independent randomized trial of ibutamoren (25 mg/day) in 123 elderly hip-fracture patients was terminated early because of a safety signal of congestive heart failure in a limited number of patients; FDA's bulk-drug-substance safety table cites this same trial when describing ibutamoren's congestive-heart-failure risk.[1][2][3]
- Neither the FDA table nor the primary trial abstract reports the exact number or rate of heart-failure events; the signal is described only qualitatively as leading to early termination in a limited number of patients.
- The heart-failure signal was observed in elderly post-hip-fracture patients at 25 mg/day; it is population- and dose-specific, not a measured risk in every user.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.
· Added the exact glucose effect size from the 1-year trial and independently located and inspected the primary hip-fracture trial (Adunsky et al. 2011) that the FDA table's ibutamoren row describes, corroborating the regulatory statement with the underlying human study rather than the regulatory citation alone.