Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: A randomized controlled trial

OBJECTIVE: In patients with gastroesophageal reflux disease (GERD), esomepr azole, the S-isomer of omeprazole, has demonstrated pharmacological and cli nical benefits beyond those seen with the racemic parent compound. This stu dy was designed to further evaluate the efficacy and tolerability of esomep razole relative to that of omeprazole in healing erosive esophagitis and re solving accompanying symptoms of GERD. METHODS: Esomeprazole 40 mg was compared with omeprazole 20 mg once daily i n 2425 patients with erosive esophagitis (Helicobacter pylori negative by s erology) in an 8-wk, multicenter, randomized, double-blind, parallel-group study conducted in 163 centers throughout the US. The primary efficacy endp oint was the proportion of patients with healed esophagitis at wk 8. Second ary endpoints were the proportion of patients healed at wk 4, resolution of heartburn at wk 4, time to first resolution and sustained resolution of he artburn, and proportion of heartburn-free days and nights. Safety and toler ability were also assessed. RESULTS: Significantly more patients were healed with esomeprazole versus o meprazole at wk 8 (93.7% vs 84.2%, p < 0.001; life table estimates, intenti on-to-treat analysis). Healing rates at wk 4 were 81.7% and 68.7%, respecti vely. Esomeprazole was superior to omeprazole for all secondary measures an d had a similar safety profile. The most common adverse events in both trea tment groups were headache, diarrhea, and nausea. CONCLUSIONS: Esomeprazole demonstrates significantly greater efficacy than omeprazole in the treatment of GERD patients with erosive esophagitis. The tolerability and safety of esomeprazole are comparable to that of omeprazol e. <(c)> 2001 by Am. Cell. of Gastroenterology.