The use and effect of OTC omeprazole for frequent heartburn

AJG – September, Suppl., 2002

699 THE USE AND EFFECT OF OTC OMEPRAZOLE FOR FREQUENT HEARTBURN A. Mark Fendrick, M.D., Michael Shaw, M.D., Bernard Schactel, M.D., Johnson McRorie, Ph.D., Julie Grender, Ph.D., Lisa Allgood, M.Sc. and David Peura, M.D.*. Internal Medicine, University of Michigan, Ann Arbor, MI; St. Louis Park, MN; Jupiter, FL; Health Sciences Institute, Procter & Gamble, Cincinnati, OH and Health Sciences Center, University of Virginia, Charlottesville, VA. Purpose: Previous studies have shown that prescription omeprazole is safe and effective for the prevention of frequent heartburn. We conducted a 3–month actual use (observational) study on consumers in an OTC setting in order to determine if they could (1) correctly self–select to use omeprazole magnesium (20.6 mg) for frequent heartburn, (2) comply with a label that called for 14 consecutive days of once– daily dosing, and (3) use the medication for more than 14 days only under the advice of a physician. Methods: More than 5000 consumers were interviewed at 5 shopping malls in geographically distinct areas of the US, and asked if they had heartburn. Of the 1999 self–reported heartburn sufferers, 866 determined the product was appropriate for their condition and purchased product; of these, 758 (89%) returned diaries documenting product usage and physician contact. Results: OTC consumers accurately self–selected (⬎90% of participants had heartburn ⬎2 days/week). Analysis of diary data revealed a high degree of compliance to label use directions: 99% of the 10,830 dosing occasions (98% of the dosing days) involved only one tablet; 95% of consumers purchased and used only one 14 –tablet carton; 79% used the product for only 14 days, or longer under the advice of a physician; 9% took ⬍11 doses, 9% took 11–14 tablets in ⬎17 days, 3% took ⬎14 doses without consulting a physician. After 3 months, 43% of subjects did not have recurrence of frequent heartburn. Of the 758 subjects, only 1 subject took more than 14 tablets without consulting a physician and had recurrence of frequent heartburn. Overall, 75% of subjects had contact with a physician about frequent heartburn prior to, during, or soon after the study (26% contacted a physician during the 3–month study). Of the 265 subjects who had never consulted a physician about heartburn before the study, 54 (20%) did so for the first time during or after the study. Conclusions: Actual use data support that availability of omeprazole in the OTC setting. Consumers accurately differentiate between frequent and occasional heartburn, comply with a 14 – day dosing regimen in the OTC setting, and appropriately seek physician involvement for longer–term management of frequent heartburn. This study was sponsored by The Procter & Gamble Health Sciences Institute. 700 IS IT BETTER TO HAVE GASTROINTESTINAL BLEEDING ON WEEKDAYS OR WEEKENDS? Sang Y. Lee, M.D., Wang Lam, M.D., Jaswinder Sandhu, M.D., Eugene Lee, M.D. and Lawrence J. Brandt, M.D., M.A.C.G.*. Gastroenterology, Montefiore Medical Center, Bronx, NY and Medicine, Jacobi Medical Center, Bronx, NY. Purpose: To compare the time to first endoscopy and length of stay for patients admitted with gastrointestinal bleeding (GIB) on weekdays and weekends. Methods: A retrospective chart review of all patient records at Jacobi Medical Center during an 18 month period: June 2000 – December 2001. GIB was defined as bleeding from either the upper or lower gastrointestinal tract that prompted an Emergenecy Department (ED) visit. Patients who visited the ED between 2pm Friday and 2pm Sunday were considered weekend admissions. Primary endpoints were time to the first endoscopy, length of hospital stay, transfusion requirements and mortality. Results: 146 patients were admitted with GIB as their primary diagnosis. 115 patients were admitted on weekdays and 31 on weekends. 44% were endoscoped during the first 24 hours, 65% during the first 48 hours, and

Abstracts

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84% during the first 72 hours. Patients admitted on weekends were significantly less likely to be endoscoped during the first 24 or 48 hours of their admission than were patients admitted on weekdays. (see table) Low initial systolic blood pressure (⬍90mmHg) significantly increased the chance of endoscopy within the first 48 hours of admission (OR 6.5, p⫽0.04) regardless of the day of admission. There was an insignificant trend towards longer hospital stays (⬎4 days) for patients who were admitted on weekends than for those admitted on weekdays (OR 0.4, p⫽0.06); this trend became significant when only patients suspected of upper tract GIB were considered (n⫽110, OR 0.3, p⫽0.04). Overall, mortality and transfusion requirements were not significantly different in the weekend and weekday groups. Conclusions: Despite the general recommendation for early endoscopy to triage patients with GIB, historical data suggest that endoscopic delay exists for these patients. We demonstrated that the day of the week patients present to the Emergency Department may be an important factor in this delay. Time to Endoscopy According to the Day of Admission

st

1 24 hours 1st 48 hours 1st 72 hours

Weekend

Weekday

P value

19% 29% 74%

50% 75% 86%

0.002 0.000003 0.11

701 RACIAL DIFFERENCES IN COMPLIANCE WITH SCREENING AND NONE–SCREENING COLONOSCOPY Yasser H. Shaib, M.D., Murtaza Parekh, M.D. and Mike Gavin, M.D.*. Departement of Internal Medicine/Gastroenterology, University of New Mexico, Albuquerque, NM. Purpose: To study differences in compliance with scheduled colonoscopy procedures between Hispanics and Whites. Methods: We collected data on all the out–patients referred for a colonoscopy to our open–access endoscopy unit between August 2001 and January 2002. Data collected included: age, sex, race, indication and compliance. Only Whites and Hispanics were included in the final analysis. According to indication patients were sorted in seven groups: 1)hard indications(hemtochezia, diarrhea..) 2)Soft indications (bloating, abdominal pain, constipation) 3)Polyps surveillance 4) Cancer surveilance 5)High risk screening 6)Average risk screening 7)Abnormal radiology exam. Compliance in the two groups was compared and results reported using p values. A logistic regression analysis was performed to study factors associated with non– compliance. Results: 978 subjects(427 Hispanics and 551Whites) were included in the final analysis. The two groups were similar except in compliance (table 1) where Hispanics were less likely to show up for their scheduled colonoscopies (p value⫽0.0014). Logistic regression analysis showed that older age was associated with lower compliance (p value ⫽0.0012). When compared based on indication (table 2), Hispanics were less likely to show up for screening colonscopies (p value⫽0.0021) but not for other indications(table2). Table 1 Comparison of the 2 groups Hispanics Averge Age Sex (M/F) Indication

Compliance

Whites

54.8 163/264 Soft (6.1%), Hard (49.4%), CS (3.3), PS (10.5%), HRS (6.8%), ARS (19.4%), AR (4.4%) 64.4%

P value

56.2 232/319 Soft (6.9%), Hard (42.5%), CS (2.7%), PS (13.8%), HRS (9.6%), ARS (20.7%), AR (3.8%) 73.9%

NS NS NS

0.0014

Table 2 Comparison of compliance by indication in the 2 groups

Hispanics Whites P value

Soft

Hard

CS

PS

HRS

ARS

AR

73.1% 76.3% NS

61.1% 69.2% NS

85.7% 80% NS

71.1% 77.6% NS

65.5% 75.5% NS

56.6% 77.2% 0.0022

89.5% 81% NS

CS: Cancer surveillance, PS: Polyp Surveillance, ARS: Average risk screening, HRS: High risk screening, AR: Abnormal radiology.