TREATMENT OF TRAVELERS DIARRHEA - ZALDARIDE COMPARED WITH LOPERAMIDE AND PLACEBO

Objective: To compare zaldaride maleate, a calmodulin inhibitor with g astrointestinal antisecretory properties, with loperamide and a placeb o in the treatment of travellers' diarrhoea. Design: Randomized, doubl e-blind, double-dummy study. Setting: Study clinic staffed by European residents on Nile cruise ships. Patients: Tourists (n = 436) who acqu ired travellers' diarrhoea during the Nile cruise. Interventions: (1) Zaldaride 20 mg four times daily, (2) zaldaride 2 x 20 mg as initial l oading dose followed by th ree doses of 20 mg on the first day and fou r doses of 20 mg on the second day, (3) loperamide 2 x 2 mg loading do se followed by a flexible dosage of 2 mg after each unformed stool (ma ximum of 16 mg daily), (4) placebo. Main outcome measures: Number of u nformed stools, rate of improvement of patients with diarrhoea, rate o f relief from diarrhoea. Results: Among the 331 compliant and fully ev aluated patients, the zaldaride with loading dose group showed no sign ificant differences in cure rates from the loperamide group. For most parameters, zaldaride without a loading dose and the placebo resulted in significantly lower cure rates. Conclusions: A zaldaride regimen in cluding a loading dose was shown to be well tolerated and as effective as loperamide.