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Clinical-Use Study of Frequent Heartburn Sufferers and Prilosec OTC

  

Research results published in the January 2004 issue of Clinical Gastroenterology and Hepatology show that frequent heartburn sufferers are able to choose the appropriate heartburn medication, follow label directions, and know when to consult a doctor for long-term management of heartburn.

"A substantial majority of people who purchased Prilosec OTC complied very well with the label instructions," said lead author Mark Fendrick, M.D., the University of Michigan professor who led the evaluation of this 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.''

The Study

A three-month study was conducted in a retail setting to determine whether consumers could choose the appropriate medication for their heartburn, follow label directions about dosing and consult a doctor when needed, as directed on the label.

The Food and Drug Administration (FDA) gave permission to set up five shopping mall kiosks (in Modesto, Calif.; West Palm, Fla.; Vernon and Trumbull, Conn.; and Atlanta, Ga.) to sell Prilosec OTC to people who agreed to enroll in the study. The study was performed as part of the application process to the FDA for permission to sell 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. Only three percent took more than the recommended 14 daily doses, even though they had the opportunity to buy more. And 75 percent had already talked with a doctor about their heartburn or did so during the three months of the study.

The study included 866 people who consented to participate, out of 1,999 people approached in the five shopping malls who said yes when asked if they had heartburn two or more days per week. The consenting participants decided to purchase Prilosec OTC based solely on reading the box label, which listed contraindications (reasons not to take the medication) and dosing schedule as well as information on the kinds of symptoms Prilosec OTC can treat.

Participants were given diaries to record their experience during and after the time they took the drug. They were called three months later to talk about symptoms and whether they had contacted a doctor about their heartburn, as the label advises.

Results

In all, 758 returned their diaries, and 649 were successfully contacted to assess whether their heartburn had come back. Nearly all (91 percent) of the patients followed the one-pill-a-day guideline perfectly, and 96 percent used one carton of 14 tablets or less — even though they were told they could purchase more at the mall kiosk for eight weeks after they received the first carton. Only one of 758 participants who completed the study took more than 14 doses, experienced a return of heartburn, and did not see a doctor. It is recommended that heartburn sufferers who have taken Prilosec OTC for a 14-day course should consult a physician before starting to take it again within four months of the previous course.

After three months, 43 percent of participants contacted by phone, and a similar proportion of those who returned a diary, reported no recurrence of their heartburn after taking Prilosec OTC. This proportion of patients who found relief after one course of Prilosec OTC is similar to that in other studies of the drug.

Another interesting finding Fendrick notes is the apparent effectiveness of the label's advice that anyone with frequent heartburn should consult a physician. Of the 265 study participants who had never consulted a doctor about their heartburn prior to the study, 54 (20 percent) consulted a doctor for the first time during the trial.

Conclusion
The study shows that in the OTC environment, consumers are able to:

• Identify whether they have frequent or occasional heartburn;
• Appropriately chose whether or not the drug is the right medication for them;
• Follow the 14-day dosing schedule;
• Seek counsel from a physician if longer-term management of their frequent heartburn is required.

Research study supported by the Procter & Gamble Health Sciences Institute.

Reference: A. Mark Fendrick, Michael Shaw, Bernard Schactel, Lisa Allgood, Greg Allgood, Julie Grender, David Peura. Clinical Gastroenterology & Hepatology, Vol. 2, No. 1, January 2004.