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Comparison of two dosing regimens of cisapride in the treatment of reflux oesophagitis.
Aliment Pharmacol Ther. 1997 Jun; 11(3):497-503.AP

Abstract

AIM

In an international, multicentre, double-blind trial, to document the therapeutic equivalence of two dosing regimens of cisapride on endoscopic healing and symptom improvement in patients with proven reflux oesophagitis grade I or II (Savary-Miller).

METHODS

Four hundred and seven patients were randomly allocated to treatment with either cisapride 10 mg q.d.s. or cisapride 20 mg b.d. for 8-12 weeks depending on whether complete healing was found at endoscopy. The primary parameters of efficacy were cure of oesphagitis and improvement of the reflux symptom score.

RESULTS

The healing rates at endpoint were 73% in both treatment groups. The mean total reflux symptom score decreased from baseline to endpoint from 7.9-2.1 (cisapride 10 mg q.d.s) and 7.9-2.5 (cisapride 20 mg b.d.). Each of the two treatment regimens was well tolerated. The most frequently (6.9%) reported adverse event (diarrhoea) was mild or moderate in most cases and can be explained by pharmacological action of cisapride.

CONCLUSIONS

The results of the study demonstrate that cisapride 10 mg q.d.s. and 20 mg b.d. are equivalent in terms of efficacy and safety in the treatment of reflux oesophagitis.

Authors+Show Affiliations

Medical Department of I, Hanusch Krankenhaus, Vienna, Austria.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9218072

Citation

Schütze, K, et al. "Comparison of Two Dosing Regimens of Cisapride in the Treatment of Reflux Oesophagitis." Alimentary Pharmacology & Therapeutics, vol. 11, no. 3, 1997, pp. 497-503.
Schütze K, Bigard MA, Van Waes L, et al. Comparison of two dosing regimens of cisapride in the treatment of reflux oesophagitis. Aliment Pharmacol Ther. 1997;11(3):497-503.
Schütze, K., Bigard, M. A., Van Waes, L., Hinojosa, J., Bedogni, G., & Hentschel, E. (1997). Comparison of two dosing regimens of cisapride in the treatment of reflux oesophagitis. Alimentary Pharmacology & Therapeutics, 11(3), 497-503.
Schütze K, et al. Comparison of Two Dosing Regimens of Cisapride in the Treatment of Reflux Oesophagitis. Aliment Pharmacol Ther. 1997;11(3):497-503. PubMed PMID: 9218072.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of two dosing regimens of cisapride in the treatment of reflux oesophagitis. AU - Schütze,K, AU - Bigard,M A, AU - Van Waes,L, AU - Hinojosa,J, AU - Bedogni,G, AU - Hentschel,E, PY - 1997/6/1/pubmed PY - 1997/6/1/medline PY - 1997/6/1/entrez SP - 497 EP - 503 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 11 IS - 3 N2 - AIM: In an international, multicentre, double-blind trial, to document the therapeutic equivalence of two dosing regimens of cisapride on endoscopic healing and symptom improvement in patients with proven reflux oesophagitis grade I or II (Savary-Miller). METHODS: Four hundred and seven patients were randomly allocated to treatment with either cisapride 10 mg q.d.s. or cisapride 20 mg b.d. for 8-12 weeks depending on whether complete healing was found at endoscopy. The primary parameters of efficacy were cure of oesphagitis and improvement of the reflux symptom score. RESULTS: The healing rates at endpoint were 73% in both treatment groups. The mean total reflux symptom score decreased from baseline to endpoint from 7.9-2.1 (cisapride 10 mg q.d.s) and 7.9-2.5 (cisapride 20 mg b.d.). Each of the two treatment regimens was well tolerated. The most frequently (6.9%) reported adverse event (diarrhoea) was mild or moderate in most cases and can be explained by pharmacological action of cisapride. CONCLUSIONS: The results of the study demonstrate that cisapride 10 mg q.d.s. and 20 mg b.d. are equivalent in terms of efficacy and safety in the treatment of reflux oesophagitis. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/9218072/Comparison_of_two_dosing_regimens_of_cisapride_in_the_treatment_of_reflux_oesophagitis_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=1997&volume=11&issue=3&spage=497 DB - PRIME DP - Unbound Medicine ER -