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July 28, 1997

A Double-blind, Placebo-Controlled Study of the Effectiveness and Safety of Nizatidine in the Prevention of Postprandial Heartburn

Author Affiliations

From the Department of Medical and Clinical Affairs, Whitehall-Robins Healthcare, Madison, NJ (Drs Spiegel and Furey, Mr Thoden, and Ms Pappas), and International Pharmaceutical Research Inc, Norwalk, Conn (Dr Fratarcangelo).

Arch Intern Med. 1997;157(14):1594-1599. doi:10.1001/archinte.1997.00440350102011

Background:  Heartburn is frequently associated with overindulgence in food and drink, meal-stimulated gastric acid secretion, and a gastroesophageal reflux with a pH of 4 or lower. Nizatidine is a selective histamine2 receptor antagonist that effectively suppresses gastric acid secretion at lower than prescription doses and has been approved for nonprescription use in the prevention of postprandial heartburn.

Objective:  To examine the relative effectiveness of 3 dose levels of nizatidine (225 mg, 75 mg, and 25 mg) in preventing postprandial heartburn.

Methods:  Four hundred thirteen subjects with documented moderate to severe heartburn following a standard meal that provoked heartburn were randomized to receive a single dose of nizatidine at 225 mg (n=104), 75 mg (n=101), or 25 mg (n=105), or placebo (n=103) 30 minutes before eating a similar provocative meal. Immediately before the meal, at 30 minutes (immediately after completing the meal), and at 60, 90,120,150,180, and 210 minutes (from beginning the meal), subjects assessed the presence or absence of heartburn (yes or no) and the severity of heartburn (100-mm visual analog scale).

Results:  The use of both 225 mg and 75 mg of nizatidine were significantly better than placebo in preventing heartburn in the proportion of subjects with complete prevention of heartburn (15 [14.4%] and 15 [14.9%], respectively, vs 3 [2.9%]; P<.001); the effects of nizatidine, 25 mg, in 7 subjects (7%) were not distinguishable from placebo. Similar results for nizatidine, 225 mg and 75 mg, were seen for longest duration of no heartburn, total duration of no heartburn, the average severity of heartburn, and the peak heartburn severity. All 3 doses of nizatidine were superior to placebo (P<.001) in reducing average and peak heartburn severity and were well tolerated.

Conclusion:  Single doses of 225 mg and 75 mg of nizatidine administered 30 minutes before a standard meal intended to provoke heartburn are significantly more effective than placebo for the prevention and/or reduction of postprandial heartburn.Arch Intern Med. 1997;157:1594-1599