Nizatidine is used for short-term treatment of endoscopically or radiographically confirmed active duodenal ulcer. Antacids may be used concomitantly as needed for relief of pain. In controlled studies in patients with endoscopically confirmed duodenal ulcers, reported rates of ulcer healing for nizatidine were substantially higher than those for placebo. In multicenter, double-blind studies in patients with endoscopically confirmed duodenal ulcer, ulcer healing with oral nizatidine 300 mg at bedtime daily, nizatidine 150 mg twice daily, or placebo occurred in 23, 27, or 10% of patients at 2 weeks; 67, 68, or 29% at 4 weeks; and 82% for the nizatidine regimens vs 49% for placebo at 8 weeks. Nizatidine also produced greater reductions in daytime and nocturnal pain and antacid consumption than did placebo, with complete relief of pain in most patients usually occurring within 4 weeks after initiation of nizatidine therapy.
Nizatidine appears to be at least as effective as cimetidine or ranitidine for short-term treatment of active duodenal ulcer. An oral nizatidine dosage of 300 mg daily at bedtime reportedly is at least as effective as an oral cimetidine dosage of 800 mg daily at bedtime. Nizatidine also appears to be as effective as ranitidine when the drugs are given in a dosage of 300 mg daily at bedtime. In a multicenter, double-blind study in patients with endoscopically confirmed duodenal ulcers, ulcer healing occurred in 81 or 80% of patients receiving nizatidine or ranitidine, respectively, in a dosage of 300 mg at bedtime for 4 weeks and in 92 or 93%, respectively, of patients receiving such therapy for 8 weeks. Patient age did not influence ulcer healing in this study; ulcers were healed in 77 or 78% of geriatric patients (i.e., those 61 years of age or older) receiving nizatidine or ranitidine, respectively, in a dosage of 300 mg daily at bedtime for 4 weeks and in 92 or 93%, respectively, of these patients following 8 weeks of such therapy. In several studies, there appeared to be little difference between nizatidine and cimetidine or ranitidine in reductions of daytime and nocturnal pain and antacid consumption.
Administration of a single daily dose of nizatidine at bedtime appears to be as effective in healing active duodenal ulcer as twice-daily administration of the drug. With an oral nizatidine dosage of 300 mg at bedtime daily or 150 mg twice daily, ulcer healing occurred in 23 or 27% of patients, respectively, at 2 weeks and 67 or 68% of patients, respectively, at 4 weeks. In several studies, ulcer healing occurred less frequently in patients who were smokers and in those with large ulcers.
Safety and efficacy of long-term nizatidine therapy (i.e., longer than 8 weeks) for active duodenal ulcer have not been determined. Most patients with duodenal ulcer respond to nizatidine therapy during the initial 4-week course of therapy; an additional 4 weeks of therapy may contribute to healing in some patients. Short-term nizatidine therapy (i.e., up to 8 weeks) for the treatment of active duodenal disease will not prevent recurrence following acute healing and discontinuance of the drug.
Current epidemiologic and clinical evidence supports a strong association between gastric infection with Helicobacter pylori and the pathogenesis of duodenal and gastric ulcers; long-term H. pylori infection also has been implicated as a risk factor for gastric cancer. For additional information on the association of this infection with these and other GI conditions, . Conventional antiulcer therapy with H2-receptor antagonists, proton-pump inhibitors, sucralfate, and/or antacids heals ulcers but generally is ineffective in eradicating H. pylori, and such therapy is associated with a high rate of ulcer recurrence (e.g., 60-100% per year). Duodenal ulcers have recurred within 12 months in about 60-80% of patients following discontinuance of H2-receptor antagonist therapy. The American College of Gastroenterology (ACG), the National Institutes of Health (NIH), and most clinicians currently recommend that all patients with initial or recurrent duodenal or gastric ulcer and documented H. pylori infection receive anti-infective therapy for treatment of the infection. Although 3-drug regimens consisting of a bismuth salt (e.g., bismuth subsalicylate) and 2 anti-infective agents (e.g., tetracycline or amoxicillin plus metronidazole) administered for 10-14 days have been effective in eradicating the infection, resolving associated gastritis, healing peptic ulcer, and preventing ulcer recurrence in many patients with H. pylori-associated peptic ulcer disease, current evidence principally from studies in Europe suggests that 1 week of such therapy provides comparable H. pylori eradication rates. Other regimens that combine one or more anti-infective agents (e.g., clarithromycin, amoxicillin) with a bismuth salt and/or an antisecretory agent (e.g., omeprazole, lansoprazole, H2-receptor antagonist) also have been used successfully for H. pylori eradication, and the choice of a particular regimen should be based on the rapidly evolving data on optimal therapy, including consideration of the patient's prior exposure to anti-infective agents, the local prevalence of resistance, patient compliance, and costs of therapy.
Current evidence suggests that inclusion of a proton-pump inhibitor (e.g., omeprazole, lansoprazole) in anti-H. pylori regimens containing 2 anti-infectives enhances effectiveness, and limited data suggest that such regimens retain good efficacy despite imidazole (e.g., metronidazole) resistance. Therefore, the ACG and many clinicians currently recommend 1 week of therapy with a proton-pump inhibitor and 2 anti-infective agents (usually clarithromycin and amoxicillin or metronidazole), or a 3-drug, bismuth-based regimen (e.g., bismuth-metronidazole-tetracycline) concomitantly with a proton-pump inhibitor, for treatment of H. pylori infection. For a more complete discussion of H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection, .
Nizatidine is used in reduced dosage as maintenance therapy following healing of active duodenal ulcer to reduce ulcer recurrence. In a placebo-controlled study, cumulative duodenal ulcer recurrence rates after 3, 6, and 12 months were 13, 24, and 34%, respectively, for 150 mg of nizatidine at bedtime daily vs 40, 57, and 64%, respectively, for placebo. Nizatidine appears to be at least as effective as ranitidine in preventing duodenal ulcer recurrence. Cumulative duodenal ulcer recurrence rates following therapy with nizatidine or ranitidine 150 mg at bedtime were 18.8 or 13.2%, respectively, at 6 months and 27.5 or 22.3%, respectively, at 12 months. Because the efficacy of H2-receptor antagonists in preventing duodenal ulcer recurrence appears to be reduced substantially in patients who are cigarette smokers compared with that in nonsmokers, patients who are smokers should be advised of the importance of discontinuing smoking in the prevention of ulcer recurrence. Safety and efficacy of nizatidine for maintenance therapy beyond 1 year have not been determined.
Nizatidine is used for short-term treatment of active, benign gastric ulcer. Antacids may be used concomitantly as needed for relief of pain. In a multicenter, double-blind study in patients with endoscopically confirmed benign gastric ulcer, reported rates of ulcer healing with oral nizatidine 300 mg at bedtime daily, nizatidine 150 mg twice daily, or placebo were 34, 43, or 32%, respectively, at 4 weeks and 65, 70, or 52%, respectively, at 8 weeks. The efficacy of nizatidine in the treatment of gastric ulcer appears to be similar to that of ranitidine, with ulcer healing rates of about 65% at 4 weeks and 83-96% at 8 weeks following therapy with either agent. Nizatidine also has produced greater reductions in epigastric pain, dyspepsia, and heartburn than placebo. Response of gastric ulcers to nizatidine therapy does not appear to be affected by patient age or gender or by cigarette smoking. Safety and efficacy of nizatidine in the treatment of gastric ulcer have not been established for periods exceeding 8 weeks. When H2-receptor antagonists are used in the treatment of gastric ulcer, it should be kept in mind that symptomatic response does not preclude the presence of a gastric malignancy.
Current epidemiologic and clinical evidence supports a strong association between gastric infection with H. pylori and the pathogenesis of gastric ulcers, and the ACG, NIH, and most clinicians currently recommend that all patients with initial or recurrent gastric ulcer and documented H. pylori infection receive anti-infective therapy for treatment of the infection. The choice of a particular regimen should be based on the rapidly evolving data on optimal therapy, including consideration of the patient's prior exposure to anti-infective agents, the local prevalence of resistance, patient compliance, and costs of therapy.
(See Duodenal Ulcer: Acute Therapy, in Uses.)For a more complete discussion of H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection, .
Nizatidine is used to provide short-term, symptomatic relief of gastroesophageal reflux. In addition, nizatidine is used for short-term (up to 12 weeks) treatment of esophagitis associated with gastroesophageal reflux, including endoscopically proven erosive or ulcerative disease. By increasing gastric pH, H2-receptor antagonists have relieved heartburn and other symptoms of reflux, and therapy with these agents has been associated with higher rates of endoscopically proven healing in patients with esophagitis when compared to those of placebo.
Suppression of gastric acid secretion is considered by the ACG to be the mainstay of treatment for gastroesophageal reflux disease (GERD), and a proton-pump inhibitor or histamine H2-receptor antagonist is used to achieve acid suppression, control symptoms, and prevent complications of the disease. The ACG states that a histamine H2-receptor antagonist administered daily in divided doses is effective in many patients with less severe GERD, and over-the-counter (OTC) antacids and histamine H2-receptor antagonists are appropriate for self-medication as initial therapy in such individuals. A histamine H2-receptor antagonist is particularly useful when taken before certain activities (e.g., heavy meal, exercise) that may result in acid reflux symptoms in some patients. The ACG states that H2-receptor antagonists generally may be used interchangeably, although the drugs may differ in potency and in their onset and duration of action. However, the ACG states that proton-pump inhibitors are more effective (i.e., provide more frequent and more rapid symptomatic relief and healing of esophagitis) than histamine H2-receptor antagonists in the treatment of GERD. Although higher doses and more frequent administration of histamine H2-receptor antagonists appear to increase their efficacy, such dosages are less effective and more expensive than proton-pump inhibitor therapy. Once-daily administration of a histamine H2-receptor antagonist at full dosage is not considered to be appropriate therapy for GERD.
Reported rates of ulcer healing with a nizatidine dosage of 150 mg twice daily generally are higher than those with placebo or a nizatidine dosage of 300 mg at bedtime in patients with endoscopically evaluated GERD. In controlled studies, healing rates with nizatidine 150 mg twice daily or placebo were, respectively, 16 or 7% at 3 weeks, 21-32 or 11-16% at 6 weeks, and 29 or 13% at 12 weeks. Patients receiving nizatidine reported faster relief of daytime and nocturnal heartburn and greater reduction in antacid consumption than those receiving placebo. H2-receptor antagonists also have been used in combination with metoclopramide in a limited number of patients who failed to respond to an H2-receptor antagonist alone, but the ACG states that frequent and potentially severe adverse CNS effects of metoclopramide have appropriately decreased regular use of the drug for GERD. Although some clinicians have suggested that a histamine H2-receptor antagonist may also be used in combination with bethanechol in patients who fail to respond to a histamine H2-receptor antagonist alone, the ACG states that bethanechol has limited efficacy in the treatment of GERD.
Short-term therapy (i.e., up to 12 weeks) with H2-receptor antagonists for the treatment of GERD will not prevent recurrence following ulcer healing and discontinuance of such therapy. Esophagitis has recurred within 6 months in up to 80% of patients following discontinuance of H2-receptor antagonist therapy. Because GERD is considered to be a chronic disease, many patients with GERD will require long-term, even lifelong, treatment. The ACG states that proton-pump inhibitors are effective and appropriate as maintenance therapy in many patients with the disease. Maintenance therapy with an H2-receptor antagonist also has been used to reduce recurrence of gastroesophageal reflux disease. However, many patients initially responding to proton-pump inhibitors experience symptomatic relapse and failure of esophageal healing with subsequent use of a histamine H2-receptor antagonist.
For further information on the treatment of GERD,
Nizatidine may be used for self-medication for prevention of symptoms of occasional heartburn (pyrosis), acid indigestion (hyperchlorhydria), or sour stomach caused by food and beverages.