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Compounded versus proprietary sincalide for evaluation of gallbladder ejection fraction.
Daniel T Guarasci1, Le Huyen N Trinh, George R Baeumler
1Department of Nuclear Medicine, University at Buffalo, Buffalo, NY 14214, USA.
The Annals of Pharmacotherapy
|February 3, 2004
Summary
Compounded sincalide showed significantly lower gallbladder ejection fraction compared to proprietary sincalide in two patients undergoing hepatobiliary scintigraphy. This highlights variability in sincalide response for accurate gallbladder function assessment.
Area of Science:
- Nuclear Medicine
- Gastroenterology
- Pharmacology
Background:
- Hepatobiliary scintigraphy is crucial for evaluating gallbladder ejection fraction (GBEF).
- Sincalide is the standard pharmaceutical used to stimulate gallbladder contraction during this procedure.
- The unavailability of proprietary sincalide led to the use of compounded alternatives, assuming therapeutic equivalence.
Observation:
- Two patients with suspected hepatobiliary dysfunction underwent GBEF assessment using both compounded and proprietary sincalide.
- Initial GBEF values with compounded sincalide were markedly lower (11% and 24%) compared to subsequent measurements with proprietary sincalide (32% and 72%).
Findings:
- Significant discrepancies in GBEF were observed between compounded and proprietary sincalide formulations.
- These differences suggest potential variability in response to sincalide, irrespective of the formulation.
Implications:
- Clinicians must be aware of potential variability in sincalide response when interpreting GBEF results.
- Concomitant medications may influence patient response to sincalide, affecting GBEF measurements.
- Further studies are needed to establish the efficacy and consistency of compounded sincalide.