An open label study to examine the effect of coated Nifedipine suppositories on analpressure in healthy subjects: OP39

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Aim:The association of anal fissure with sphincter hypertonicity has been postulated for many years. Therapeutic options at breaking this hypertonicity-fissure cycle include the use of nitrates and calcium channel blockers. However the use of these agents has been limited due to systemic absorption and adverse events. Our aim was to examine the safety and the effect of various doses of coated Nifedipine suppository, a newly developed drug delivery method, on anal resting and squeeze tone in healthy human volunteers.Method:An open-label, dose-finding study in eight healthy volunteers. Subjects who met all criteria entered a one day treatment. Four anal manometric studies were performed. Study medication has been administered atpre-determined intervals. Blood samples were obtained for plasma Nifedipine analysis.Results:Nifedipine coated suppositories (12 mg and 24 mg) were shown to reduce restingpressure by 20% (P = 0.03) and 29% (P = 0.0006) and maximal squeezepressures (by 13% and 17% respectively, P > 0.05) without affecting bloodpressure or heart rate. This effect lasted for more than 4 hours. No adverse effects were recorded.Conclusion:The use of Nifedipine coated suppositories is safe and efficient in lowering anal sphincterpressures. Its use mayprove to be efficient treatment for chronic anal fissure.

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