ZALDARIDE MALEATE (A NEW CALMODULIN ANTAGONIST) VERSUS LOPERAMIDE IN THE TREATMENT OF TRAVELERS DIARRHEA - RANDOMIZED, PLACEBO-CONTROLLED TRIAL

The present study was undertaken to compare the efficacy of a new calm odulin antagonist, zaldaride maleate, with that of placebo or loperami de in persons with traveler's diarrhea. One hundred seventy-nine patie nts were randomized to receive loperamide (4 mg followed by 2 mg after each unformed stool), zaldaride maleate (20 mg four times per day), o r placebo, During the initial 48 hours of therapy, zaldaride maleate d ecreased the number of unformed stools by 30% and the duration of illn ess by 23% when compared with placebo, Loperamide was superior to both zaldaride maleate and placebo during the initial hours of treatment. However, after 48 hours of treatment, loperamide and zaldaride maleate were equally efficacious, decreasing by >50% the number of unformed s tools passed in a 24-hour interval (P, not significant), and were both superior when compared with placebo (P <.0001 and P =.0048, respectiv ely), The apparent superiority of loperamide early in the course of th erapy appeared to be related to a loading-dose effect and not to any d ifferences in antidiarrheal properties.