Drug updated on 3/28/2024
| Dosage Form | Suspension (oral: 60 mg) |
| Drug Class | Growth hormone secretagogue receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the diagnosis of adult growth hormone deficiency.
Summary
- Macimorelin acetate (Macrilen) is indicated for the diagnosis of adult growth hormone deficiency (AGHD).
- A total of 1 randomized controlled trial document was reviewed, providing information about the efficacy and safety of macimorelin in diagnosing AGHD.
- The study included subjects with high, intermediate, and low likelihood for AGHD as well as healthy controls; this diverse population allows a comprehensive evaluation of macimorelin's diagnostic utility across different patient profiles.
- Compared to insulin tolerance test (ITT), which is considered the reference standard GH stimulation test but has limitations such as labor intensity and risk of severe hypoglycemia, single-dose oral macimorelin demonstrated comparable accuracy in diagnosing AGHD while being simpler to administer and better tolerated by patients.
- Using a growth hormone cutoff level specific to each test method - 2.8 ng/mL for macimorelin versus 5.1 ng/mL for ITT - resulted in negative agreement rates above 95% between both tests; however, using an equal cutoff value at 5.1 ng/mL improved positive agreement from approximately 74% to over 82%, suggesting that adjusting the threshold could enhance diagnostic concordance between these two methods.
- No serious adverse events were reported during testing with Macrilen indicating its relative safety compared to other available options like ITT which can cause severe hypoglycemia among certain patients groups where it is contraindicated.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Macrilen (macimorelin acetate) Prescribing Information. | 2021 | Novo Nordisk Inc., Plainsboro, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Macimorelin as a diagnostic test for adult GH deficiency. | 157Subjects F: 41% M: 59% | 2018 | The Journal of Clinical Endocrinology & Metabolism |
Sex Distribution:
F:41%
M:59%
157Subjects
Year:
2018
Source:The Journal of Clinical Endocrinology & Metabolism