Summary

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• Macrilen (macimorelin acetate) is indicated for the diagnosis of adult growth hormone deficiency.
• This summary is based on the review of one randomized controlled trial. ^[1]
• Efficacy of Macimorelin: Macimorelin demonstrated high sensitivity (87%) and specificity (96%) in diagnosing AGHD, with a positive agreement of 74.32% (95% CI, 63% to 84%) and a negative agreement of 95.38% (95% CI, 87% to 99%). Reproducibility on retesting was 97% (n = 33).
• Post Hoc Analysis: Using a GH cutoff of 5.1 ng/mL for both Macimorelin and ITT, Macimorelin showed improved positive agreement of 82% (95% CI, 72% to 90%) and high sensitivity (92%) and specificity (96%).
• Safety Profile of Macimorelin: No serious adverse events were reported in subjects administered Macimorelin, indicating a favorable safety profile.
• Subgroup Findings: Macimorelin demonstrated high effectiveness and safety across subjects with varying likelihoods of adult growth hormone deficiency (AGHD), including those with high (n=38), intermediate (n=37), and low (n=39) likelihood, as well as healthy controls (n=25), with high reproducibility (97%) and agreement metrics (positive agreement: 74.32-82%, negative agreement: 94-95.38%).