COSCIENS Biopharma Inc T.AEZS

AEZS's test vs. the clonidine and an arginine test

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AEZS's pediatric trial: clinicaltrials.gov, "The macimorelin test will be compared to a clonidine and an arginine test."

How does AEZS's test compare to those tests? I don't know the GH cutoff chosen in AEZS's pediatric trial. Below 5.1 ng/mL was assumed and was a superior cutoff in previous macimorelin results. You can see how an oral test would be superior for children. 

Perplexity Ai: 

Based on the search results, macimorelin does appear to have several advantages over clonidine and arginine tests for diagnosing growth hormone deficiency (GHD), which could make it a preferred option. Here are the key points:

Advantages of Macimorelin

1. Higher Sensitivity:
   • Macimorelin: 92-93% sensitivity at a GH cutoff of 5.1 ng/mL.
   • Clonidine: Approximately 85% sensitivity.
   • Arginine: Approximately 78% sensitivity.
2. Reproducibility:
   • Macimorelin: 94% reproducibility.
   • ITT: Varies, but generally less consistent, especially in different patient populations.
3. Safety and Tolerability:
   • Macimorelin is well-tolerated with fewer side effects, primarily mild dysgeusia (unpleasant taste).
   • Clonidine can cause hypotension and drowsiness, which may prolong fasting and induce hypoglycemia.
   • Arginine can cause nausea, vomiting, and other side effects.
4. Convenience:
   • Macimorelin is orally administered and has a shorter test duration (90 minutes).
   • Clonidine and arginine tests require intravenous administration and can be more time-consuming.

Potential for Becoming the Go-To Test

Given these advantages, macimorelin is likely to become a preferred diagnostic test for GHD. Its higher sensitivity and reproducibility, combined with ease of administration and better safety profile, make it a strong candidate for widespread use.

Impact on Misdiagnosis

Regarding whether macimorelin leads to fewer people being treated for GHD who shouldn't be:

• Specificity: Macimorelin has a high specificity of 96-97% at the 5.1 ng/mL cutoff. This means it has a low rate of false positives, which reduces the likelihood of misdiagnosing individuals without GHD as having the condition.
• Comparison to Other Tests: The specificity of macimorelin is comparable to or better than other tests, suggesting it is effective in correctly identifying those without the condition.

Conclusion

Macimorelin's superior sensitivity, reproducibility, and safety profile, along with its convenience, make it a strong candidate to become the go-to test for diagnosing GHD. Its high specificity also suggests it is less likely to result in unnecessary treatment for individuals who do not have GHD. However, the final adoption will depend on further validation, especially in pediatric populations, and considerations of cost and availability.

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