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Title: Combination Treatment Optimal for Travelers' Diarrhea: Presented by DDW
URL: http://www.pslgroup.com/dg/1F0036.htm
Doctor's Guide
May 24, 2006


By Bruce Sylvester

LOS ANGELES, C.A. -- May 24, 2006 -- Combination treatment with rifaximin and loperamide leads to rapid symptomatic improvement and clinical cure for nondysenteric travelers' diarrhea, and is considered an optimal treatment for the condition, researchers reported here at Digestive Disease Week 2006 (DDW).

"Travelers' diarrhea is caused by bacteria in food, and antibiotics are the most commonly used way to treat the condition," stated lead investigator Herbert DuPont, MD, director, Center for Infectious Diseases, University of Texas School of Public Health, and chief, internal medicine, St. Luke's Episcopal Hospital, Houston, Texas.

"Antibiotics, however, take between 24 hours to 30 hours to work. We want to get people well more quickly," he said.

In this study, Dr. DuPont and colleagues combined loperamide (Imodium) with the antibiotic rifaximin, and compared results with the 2 drugs when each was given alone.

"What we found," Dr. DuPont explained, "is that loperamide gave immediate relief from the diarrhea, and the antibiotic cured the disease and kept people well. We now think that [this combination] is the optimal way to manage traveler's diarrhea."

The investigators enrolled 315 subjects who were at least 18 years of age from the United States who were studying in Mexico during the summers of 2004 and 2005 and who had developed acute diarrhea (passage of 3 or more unformed stools in a 24-hour period with at least 1 sign/symptom of enteric infection) lasting up to 72 hours.

Subjects received 1 of 3 drug regimens: rifaximin 200 mg 3 times daily for 3 days; loperamide 4 mg daily initially followed by 2 mg after each unformed stool, not to exceed 8 mg/day for 48 hours; or both drugs in combination, using the formerly stated dosage schedules.

Over the 5-day study period, the median time from first dose of study drug until passage of the last unformed stool was shorter for both groups using rifaximin: rifaximin alone, 23 hours; rifaximin/loperamide, 19.5 hours; and loperamide alone, 41.5 hours (P =.01). Placebos were used to blind the study.

The incidence of treatment failure (not achieving wellness in 5 days) was lower in both rifaximin-using groups: rifaximin alone, 7.5%, rifaximin/loperamide 6.5%, and loperamide alone 16.3% (P =.032).

The median/mean numbers of unformed stools passed during acute illness was lower with rifaximin/loperamide (2.5/3.99) than with either treatment alone: rifaximin (4/6.23) or loperamide (4/6.72) (P =.002/.004).

In the first 10 hours after dosing, results for the time to passage of last unformed stool were better for loperamide monotherapy. After the first 10 hours of treatment, however, results favored rifaximin-containing regimens.

"We have about 18 million people from the United States who go to Mexico every year, and about 50 million visitors worldwide to developing counties from developed countries. Forty percent get travelers' diarrhea," said Dr. Dupont. "We are talking about huge numbers here, more than 20 million people annually."

Dr. DuPont concluded by suggesting that the combination therapy made sense not only in terms of treating travelers' diarrhea, but in preventing future gastrointestinal distress for these patients.

"Past studies have shown that 10% of patients with travelers' diarrhea progress to the development of irritable bowel syndrome, potentially entailing a lifetime of gastrointestinal complaints. This translates to 2 million new cases of travelers' diarrhea-related irritable bowel syndrome developing each year," he added.


[Presentation title: Treatment of Travelers' Diarrhea: Rifaximin, Rifaximin Plus Loperamide or Loperamide Alone. Abstract M1160]

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