Peura DA, Riff DS, Snoddy AM, Fennerty MB
Clinical trial: Lansoprazole 15 or 30 mg once daily vs placebo for treatment of frequent nighttime heartburn in self-treating subjects. [JOURNAL ARTICLE]
Aliment Pharmacol Ther 2009 Jun 11.
Summary Background Frequent nighttime heartburn is common. Lansoprazole 15 mg is indicated for treatment of heartburn and other GERD-related symptoms. Aim To evaluate the efficacy and safety of lansoprazole in self-treating subjects with frequent nocturnal heartburn. Methods 864 subjects with heartburn on >/=2 days per week over the past month were randomized to double-blind treatment with lansoprazole 15 mg or 30 mg, or placebo each morning. Endpoints were percentage of nighttimes without heartburn (primary), percentage of 24-hour 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-hour days without heartburn and percentage of subjects without heartburn on day 1 were significantly greater with lansoprazole 15 mg 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-hour 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.
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