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Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain
Date:6/1/2009

However, NSAIDs are associated with a range of adverse side effects, which primarily affect the GI tract. Up to 30 percent of patients taking NSAIDs experience GI ulcers, and even more suffer from upper GI symptoms (e.g., dyspepsia, heartburn). Serious NSAID-induced GI toxicity causes an estimated 16,500 deaths and more than 107,000 hospitalizations annually in the U.S. alone.

Famotidine, when used at high doses (80 mg), has shown a significant two-fold reduction in the incidence of NSAID-induced ulcers. In addition, famotidine provides other distinct advantages, including an excellent long term safety profile with more than 20 million patients treated worldwide, demonstrated safety up to 10 times the approved prescription dose at six months and data supporting low risk of serious adverse events. The most frequent adverse effects reported with the use of single ingredient famotidine include headache.

About REDUCE-1 and REDUCE-2

REDUCE-1 and REDUCE-2 were two randomized, double-blind, controlled trials that enrolled more than 1500 patients with mild-to-moderate pain. Patients were randomly assigned, in approximately a 2:1 ratio, to receive either HZT-501 (800 mg ibuprofen and 26.6 mg famotidine) or ibuprofen (800 mg) alone orally three times daily for a 24-week treatment period or until patients developed either an endoscopically diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Patients received endoscopies at baseline and weeks 8, 16 and 24.

The primary efficacy objective of REDUCE-1 was to evaluate HZT-501 in reducing the proportion of patients who develop endoscopically diagnosed gastric ulcers during the 24-week treatment period, as compared to ibuprofen, in patients at risk for NSAID-induced ulcers. The primary objective of REDUCE-2 was to evaluate HZT-501 in reducing the proportion of patients who develop endoscopically diagnosed gastric and/or duodenal ulcers during
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SOURCE Horizon Therapeutics, Inc.
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