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Bernard A. Schwetz, DVM,PhD

JAMA. 2001;285:1696.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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 . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration

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