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News From the Food and Drug Administration
April 4, 2001

Drug for Esophagitis and GERD

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JAMA. 2001;285(13):1696. doi:10.1001/jama.285.13.1696-JFD10003-2-1

The FDA has approved esomeprazole magnesium (Nexium delayed-release capsules, AstraZeneca Pharmaceuticals LP, Wilmington, Del) for short-term treatment (4-8 weeks) for healing and symptomatic resolution of erosive esophagitis and for maintenance of both end points. The enteric-coated product is also indicated for treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD).

The 8-week healing rates, sustained heartburn resolution, and time to sustained heartburn resolution of 40-mg and 20-mg dosages of esomeprazole were compared with a 20-mg per day dosage of omeprazole in four multicenter, double-blind, randomized studies of a total of 6000 patients with endoscopically diagnosed erosive esophagitis. When esomeprazole 20 mg was compared with omeprazole 20 mg, one study found no difference. Another found an 8% difference in healing rates of esophagitis at 4 or 8 weeks (P<.05). No difference was found in resolution of heartburn. The two other studies compared the 40-mg dosage of esomeprazole with 20 mg of omeprazole and found statistically higher healing rates (94.1% and 93.7% vs 86.9% and 84.2%, respectively) at 8 weeks (P<.001). Resolution of heartburn was also better with 40 mg of esomeprazole (74.2% and 75.1% vs 66.6% and 70.8%, respectively) on day 29 (P<.001).