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Oral macimorelin effectively diagnosed adult GH deficiency
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Results from a multicenter, open-label study reveal that a novel oral test agent could be a quick and simple diagnostic tool for adult growth hormone deficiency.
Researchers compared the accuracy of macimorelin (formerly known as AEZS-130) — a ghrelin receptor agonist — with arginine plus GH-releasing hormone (GHRH) in patients with adult GH deficiency (AGHD) and healthy, matched controls.
Following the testing of 43 patients with AGHD and 10 controls, the GHRH analogue GHRH(1-29)NH2 (Geref Diagnostic) became unavailable in the United States. However, the current study was completed by testing an additional 10 patients with AGHD and 38 controls with macimorelin alone.
The researchers wrote that obesity was observed in 58% of patients and peak GH levels were inversely linked to BMI in controls (P=.01).
According to data, the peak GH levels among patients with AGHD were 2.36 ng/mL and 17.71 ng/mL in controls after macimorelin therapy (P<.0001).
The receiver operating characteristic (ROC) analysis with macimorelin demonstrated a GH peak of 2.7 ng/mL (with 82% sensitivity, 92% specificity and 13% misclassification rate), researchers wrote. In patients who underwent both tests, macimorelin displayed bias compared with arginine plus GHRH (ROC-AUC, 0.99 vs. 0.94), researchers added. Using separate thresholds of 6.8 ng/mL in nonobese patients and 2.7 ng/mL for obese patients, researchers found that the misclassification rate decreased to 11%.
The researchers wrote that adverse events were mild or moderate, and only one drug-related serious adverse event was observed with macimorelin (ie, asymptomatic QT prolongation and nonspecific T wave abnormalities, resolving within 24 hours).
“Our study demonstrates that a novel oral ghrelin mimetic is both safe and accurate in diagnosing AGHD. The peak GH response after macimorelin allows establishment of the diagnosis of AGHD with good sensitivity and specificity,” researchers wrote. “Furthermore, this test was well tolerated by patients and does not require parenteral administration of the agent.”
Disclosure: See the study for a full list of disclosures.
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