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Updated 2:00 PM January 19, 2004



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Heartburn sufferers follow directions well
for over-the-counter Prilosec

Since it was first made available in September 2003, Prilosec OTC has become one of the leading over-the-counter remedies for treating frequent heartburn. Prilosec OTC contains the same active drug component (omeprazole) as prescription Prilosec.

Some health professionals have questioned whether consumers would use the over-the-counter product as intended. But research published Jan. 9 in the journal Clinical Gastroenterology and Hepatology shows that frequent heartburn sufferers are able to follow and comply with the directions on the package label.

"A substantial majority of people who purchased Prilosec OTC complied very well with the label instructions," says lead author Dr. Mark Fendrick, the U-M professor who led the evaluation of the study. "And, contrary to some concerns that Prilosec OTC would result in decreased physician visits, this study showed that frequent heartburn sufferers actually increased consultation with their physicians."

Fendrick is professor, Division of General Medicine; professor, Department of Health Management and Policy, School of Public Health; core faculty, Robert Wood Johnson Clinical Scholars Program; and director, Health Services Research Core Laboratory.

Five shopping mall kiosks in California, Connecticut, Florida and Georgia were set up for the study, with permission from the Food and Drug Administration (FDA) to sell Prilosec OTC to people who agreed to enroll. The study was performed as part of Proctor & Gamble's application process to the FDA for permission to market Prilosec OTC as an over-the-counter drug.

More than 90 percent of consumers who decided to buy the drug had frequent heartburn, the condition for which Prilosec OTC has FDA approval.

Nearly all (91 percent) of the patients followed the one-pill-a-day guideline perfectly. Only 3 percent took more than the recommended 14 daily doses, even though they had the opportunity to buy more. And 75 percent already had talked with a doctor about their heartburn or did so during the three months of the study, as recommended by the package label.

The research study was supported by the Procter & Gamble Health Sciences Institute, and Fendrick is a paid research consultant for this organization.

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