Effectiveness and safety of nizatidine, 75 mg, for the relief of episodic heartburn

Background: The most frequent cause of episodic heartburn is food and beverage ingestion. Nizatidine, an H-2-receptor antagonist, is currently approved for non-prescription use in the prevention and relief of heartburn at a dose of 75 mg up to twice a day. Methods: Two identical studies were carried out to evaluate the efficacy of nizatidine, 75 mg, compared with placebo in treating heartburn in an 'at-home' setting. The studies were multicentre, multiple-dose, placebo-controlled, randomized, parallel group design. A total of 994 subjects were randomized to treatment. Adequate relief of heartburn was assessed at 15, 30 and 45 min and 1, 2 and 3 h following a treatment dose. A subject's responses with respect to time to relief and attainment of adequate relief were combined into a derived response profile, the sustained adequate relief score. Adverse experiences were noted throughout the study period. Results: The individual and combined study results showed that nizatidine, 75 mg, relieved heartburn faster and/or more consistently than placebo. The mean sustained adequate relief score, calculated over a subject's first four episodes, was 2.43 in the nizatidine-treated group compared with 2.14 in the placebo group (P<0.001). Nizatidine-treated subjects attained sustained adequate relief in a significantly (P<0.001) larger percentage (75%) of their heartburn episodes than did subjects treated with placebo (66%). No serious adverse experiences were associated with nizatidine treatment. Conclusion: Nizatidine, 75 mg, is a safe and effective treatment for episodic heartburn. The results showed that subjects taking nizatidine had heartburn relief that was achieved faster and/or more reliably than did subjects taking placebo.