Katz P O, Castell D O, Levine D
Department of Gastroenterology, Albert Einstein Medical Center, Philadelphia, PA 19141, USA.
Aliment Pharmacol Ther. 2003 Nov 1;18(9):875-82. doi: 10.1046/j.1365-2036.2003.01771.x.
Patients with chronic heartburn but with no endoscopic evidence of erosive oesophagitis require gastric acid suppression to relieve symptoms.
To assess the efficacy and safety of esomeprazole in patients with frequent heartburn for >or = 6 months and no evidence of erosive oesophagitis on endoscopy.
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.
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 < or = 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 < or = 0.008). The spectrum and frequency of adverse events with esomeprazole were similar to those with placebo.
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.
