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Esomeprazole resolves chronic heartburn in patients without erosive oesophagitis
Author(s) -
Katz P. O.,
Castell D. O.,
Levine D.
Publication year - 2003
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2003.01771.x
Subject(s) - heartburn , esomeprazole , medicine , placebo , gastroenterology , adverse effect , esophagitis , esophageal disease , reflux , esophagus , alternative medicine , disease , pathology
Summary Background : Patients with chronic heartburn but with no endoscopic evidence of erosive oesophagitis require gastric acid suppression to relieve symptoms. Aim : To assess the efficacy and safety of esomeprazole in patients with frequent heartburn for ≥ 6 months and no evidence of erosive oesophagitis on endoscopy. Methods : Two randomized, double‐blind, 4‐week, multi‐centre trials with identical methodology compared once‐daily esomeprazole, 40 mg ( n = 241) or 20 mg ( n = 234), with placebo ( n = 242) for the rigorous end‐point of complete resolution of heartburn. Secondary end‐points included the percentage of heartburn‐free days and the time to first and sustained resolution of heartburn. Results : Patients treated with either dose of esomeprazole were two to three times more likely to achieve complete resolution of heartburn than patients treated with placebo ( P < 0.001). The percentage of heartburn‐free days was significantly higher with esomeprazole 40 mg (63%, 66%) or 20 mg (63%, 68%) than with placebo (46%, 36%; P ≤ 0.001) in each of the two studies. Esomeprazole was associated with a significantly shorter mean time to first (6–7 days) and sustained (12–17 days) resolution of heartburn compared with placebo (first, 10–12 days; sustained, 21–22 days; P ≤ 0.008). The spectrum and frequency of adverse events with esomeprazole were similar to those with placebo. Conclusions : Esomeprazole, at daily doses of 40 mg or 20 mg, is effective and safe for the treatment of chronic heartburn in patients without erosive oesophagitis.