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 H2-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.


CONCLUSIONS
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.
Paul
K
K
Clinical Research Department, Whitehall-Robins Healthcare, 5 Giralda Farms, Madison, NJ 07940, USA.
Redman
C M
CM
Chen
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005745:Gastric Acidity Determination; D006356:Heartburn / Q000188:drug therapy*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D016567:Nizatidine / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D006635:Histamine H2 Antagonists; D016567:Nizatidine