ArticlePituitary2026
Real-world diagnostic performance of the macimorelin stimulation test in the diagnosis of adult growth hormone deficiency.
Article in Pituitary, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeMacimorelin, a ghrelin receptor agonist, is used for diagnosing adult GH deficiency (AGHD). The FDA-approved GH cut-off is 2.8 ng/mL, whereas post-hoc analyses proposed a cut-off of 5.1 ng/mL. The real-world performance of these cut-offs, the influence of body mass index (BMI), and the need for 90-minute sampling remain unclear.
methodsRetrospective single-center study of adults undergoing Macimorelin stimulation testing. Patients were categorized into high, intermediate, and low pre-test probability for AGHD. Diagnostic classification at the 2.8 and 5.1 ng/mL cut-offs were compared using exact McNemar test, with estimation of the absolute diagnostic yield differences and corresponding 95% confidence intervals. BMI was compared between discordant and concordant patients and agreement between 60- and 90-minute GH values was assessed.
resultsAmong 37 patients, 15 (40.5%) met AGHD criteria using the 2.8 ng/mL cut-off, compared with 20 (54.0%) using the 5.1 ng/mL, corresponding to an absolute diagnostic yield difference of 13.5% (95% CI, 2.5%–24.5%; two-sided exact McNemar p = 0.0625). Of the five discordant patients, one was in the high and one in the intermediate, and three were in the low pre-test probability group (all three with BMI > 35 kg/m²). In the low pre-test probability group, BMI demonstrated a monotonic inverse association with peak GH (Spearman ρ = − 0.67, p = 0.006) and was on average higher in discordant vs. concordant patients (37.7 ± 2.7 vs. 28.2 ± 4.6 kg/m²), corresponding to a mean difference of 9.5 kg/m² (95% CI, 5–14 kg/m²). GH values at 60 and 90 min were highly correlated (r = 0.775, p < 0.0001) and excluding the 90-minute sample did not alter diagnostic outcomes.
conclusionApplying the 5.1 ng/mL cut-off classified more AGHD cases than 2.8 ng/mL, with discordant classifications concentrated among patients with higher BMI in low pre-test probability group, suggesting obesity may contribute to diagnostic reclassification. Diagnostic classification was unchanged when the 90-minute sample was omitted in our cohort.
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