Clinical trial: lansoprazole 15 or 30 mg once daily vs. placebo for treatment of frequent nighttime heartburn in self‐treating subjects

• Published in: Alimentary pharmacology & therapeutics Vol. 30; no. 5; pp. 459 - 468
• Main Authors: PEURA, D. A., RIFF, D. S., SNODDY, A. M., FENNERTY, M. B.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.09.2009; Blackwell
• Subjects: 2-Pyridinylmethylsulfinylbenzimidazoles - administration & dosage; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents - administration & dosage; Biological and medical sciences; Digestive system; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Gastroenterology. Liver. Pancreas. Abdomen; Heartburn - drug therapy; Humans; Lansoprazole; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Young Adult; Human; Enzyme; H; Enzyme inhibitor; K; Proton pump inhibitor; Treatment; Benzimidazole derivatives; Antisecretory agent; Placebo; exchanging ATPase; Hydrolases; Single daily dose; Clinical trial; Frequency; Daily dose; Comparative study; Lansoprazole
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2009.04064.x

Summary Background  Frequent nighttime heartburn is common. Lansoprazole 15 mg is indicated for treatment of heartburn and other gastro‐oesophageal reflux disease‐related symptoms. Aim  To evaluate the efficacy and safety of lansoprazole in self‐treating subjects with frequent nocturnal heartburn. Methods  A total of 864 subjects with heartburn on ≥2 days/week over the past month were randomized to double‐blind treatment with lansoprazole 15 or 30 mg or placebo each morning. Endpoints were percentage of nighttimes without heartburn (primary), percentage of 24‐h days without heartburn and percentage of subjects without heartburn on day 1. Results  Mean percentage of nighttimes without heartburn was significantly greater with lansoprazole 15 mg (61.3%) or lansoprazole 30 mg (61.7%) vs. placebo (47.8%) over 14 days (P < 0.0001 vs. placebo for both doses). Percentage of 24‐h days without heartburn and percentage of subjects without heartburn on day 1 were significantly greater with lansoprazole 15 or 30 mg vs. placebo. Conclusions  Both lansoprazole 15 and 30 mg were highly effective and well tolerated in reducing symptoms in subjects with frequent nighttime heartburn. The benefit of therapy on 24‐h heartburn and nighttime heartburn on day 1 of treatment was also evident. Lansoprazole 15 mg is a suitable choice for management of frequent nighttime heartburn.