Abstract
Purpose
Triflusal is an antiplatelet agent that irreversibly acetylates cyclooxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. It was initially marketed as capsules containing 300 mg of active substance. In 2006 a new 600 mg (10 ml) oral solution form of triflusal was authorized in Spain. The primary aim of this study was to compare the gastrointestinal safety of the new triflusal oral solution with triflusal capsules in healthy volunteers.
Methods
Sixty healthy subjects were randomly assigned, in a 2.5:2.5: 1 ratio, into one of three groups, with 25 subjects receiving one bottle of triflusal oral solution (600 mg) daily, 25 subjects receiving two triflusal capsules (600 mg) once daily, and ten subjects receiving two placebo capsules once daily, respectively, during 7 consecutive days. Gastroscopy was performed at baseline before the administration of study drugs and after 4–8 h of the last dose of study drugs. Effects on the esophagus, stomach, and duodenum were measured in accordance with a modified Lanza scale.
Results
No differences between groups were detected at baseline. After treatment, median global scores in the placebo, triflusal solution, and triflusal capsules groups were, respectively, 0, 1, and 3 (p = 0.003 for comparison between placebo and triflusal capsules and p = 0.042 for comparison between triflusal solution and triflusal capsules). There were no significant differences between the scores on the triflusal solution and placebo groups. All treatments were well tolerated.
Conclusion
In healthy subjects, triflusal solution induced less endoscopically apparent gastrointestinal mucosal damage than triflusal capsules and did not induce more damage than the placebo in healthy volunteers.
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Acknowledgments
The authors thank J. Uriach y Compañía, S.A. (Palau-solità I Plegamans, Barcelona, Spain) for financial support to this study, and to Montserrat Puntes, Joan Martínez, and Salvador Rico for their assistance during data collection. This study was partially supported by the National Scientific Research Program of the Spanish Ministry of Science and Technology.
Conflict of interest
Iñaki Izquierdo, Javier Borja, and Iris Blanch are employees of J. Uriach y Compañía, S.A. Esther Donado was an employee of J. Uriach y Compañía, S.A. when the study was performed. Manel Barbanoj has been an external advisor of J. Uriach y Compañía, S.A.
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Antonijoan, R.M., Gich, I., Azaro, A. et al. Gastrointestinal safety of triflusal solution in healthy volunteers: a proof of concept endoscopic study. Eur J Clin Pharmacol 67, 663–669 (2011). https://doi.org/10.1007/s00228-011-1004-9
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DOI: https://doi.org/10.1007/s00228-011-1004-9