Some health professionals have questioned whether consumers will use the over-the-counter product as intended. But research published today 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" 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 shows that consumers can use Prilosec OTC correctly to manage their frequent heartburn", said co-author Greg Allgood, Ph.D., Associate Director at the P&G Health Sciences Institute. "This research supports the U.S. Food and Drug Administration's decision to make Prilosec OTC more readily accessible to the tens of millions of Americans with frequent heartburn."
Five shopping mall kiosks (in Modesto, CA, West Palm, FL, Vernon and Trumbull, CT, and Atlanta, GA) were set up for the study, with permission from the FDA to sell Prilosec OTC to people who agreed to enroll. The study was performed as part of P&G'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. Only 3 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 and dosing regimen as well as information on the kinds of symptoms Prilosec OTC can ease.
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.
In all, 758 returned their diaries, and 649 were successfully contacted to assess whether their heartburn had come back. Their demographic characteristics did not differ substantially from the group that reported heartburn, but did not take part in the study.
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. In general, 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.
Just over 9 percent of participants who purchased Prilosec OTC reported having contraindicated symptoms which they had not yet discussed with a doctor; all of them stayed within the 14-dose regimen. Fifteen of the 866 participants reported taking contraindicated medications such as warfarin, diazepam or phenytoin; 13 of them consulted a physician during or soon after the study.
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.
This research study was supported by the Procter & Gamble Health Sciences Institute, and Fendrick is a paid research consultant for this organization.
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.