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Comparison of Omeprazole to Placebo in 24-Hour Prevention of Frequent Heartburn

Mervyn Danilewitz1, Lisa Allgood2, Michael Shaw3 and David Peura4
1AstraZeneca LP, Chesterbrook, PA
2Procter & Gamble Health Sciences Institute, Cincinnati, OH
3Park Nicolet, St. Louis Park, MN
4University of Virginia, Charlottesville, VA

Purpose: Two trials investigated the effectiveness of omeprazole magnesium (Prilosec) in the treatment of frequent heartburn (2 or more days/wk). The primary objective was to demonstrate that a single dose of omeprazole completely prevents heartburn symptoms for 24 hours.

Methods: Over 3120 subjects were randomized to take 10 mg omeprazole, 20 mg omeprazole, or placebo in multicenter, double blind, placebo controlled, parallel studies with a 1-week placebo run-in phase to assess the heartburn frequency. Eligible subjects were randomized into a 2-week double-blind phase, where single doses of omeprazole or placebo were taken every morning. Analyses tested the effectiveness of omeprazole in preventing heartburn over 24 hours on Day 1 (following the first dose), on Day 14 (following the last dose), and on the percentage of days during the 2-week use period when a subject was without heartburn. The effect on nocturnal heartburn was also assessed.

Results: For Day 1 of both studies, omeprazole at 10 mg and omeprazole at 20 mg were both statistically superior to placebo for percent of subjects heartburn free after a single dose (p<0.003) as well as after the last dose on Day 14 (p<0.001). Across all 14 days in both studies, both doses of omeprazole were statistically superior to placebo for percent of days heartburn free (p<0.001). Day 1 results for study 171 showed omeprazole at 20 mg superior vs. omeprazole at 10 mg (p=0.008) and across all 14 days results for study 183 showed omeprazole at 20 mg superior to omeprazole at 10 mg (p<0.001).

Percentage of Subjects with No Heartburn
Study Period Ome20 mg Ome10mg Placebo
171 Day 1 49.7% 41.5% 32.6%
  Day 14 69.7% 71.7% 42.7%
183 Day 1 46.8% 45.2% 32.1%
  Day 14 73.0% 66.4% 43.0%

Percentage of Days with No Heartburn Across 14 Days
Study Ome20 mg Ome10mg Placebo
171 64.4% 60.8% 39.4%
183 67.8% 61.4% 37.9%

For no nocturnal heartburn, both omeprazole at 10 and 20 mg were superior vs. placebo on day 1 (study 171: p<0.004) and across all 14 days (p<0.001 in both studies). In study 183, omeprazole at 20 mg was superior vs. omeprazole at 10 mg across all 14 days (p=0.013).

Conclusion: Omeprazole is effective in completely preventing heartburn for one full day after the first dose. Maximum effect was achieved between Day 3-5, and the high level of effect was maintained through Day 14. The effect in preventing nocturnal heartburn was significant. Furthermore, the results from the trial indicated that omeprazole is well tolerated and has similar safety profiles when compared to placebo.

Danilewitz, M, L Allgood, M Shaw, D Peura. Comparison of Ompreazole to Placebo in 24 hour Prevention of Frequent Heartburn. American College of Gastroenterology Annual Meeting. Seattle, Washington, September 2002 (P415).

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