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Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users
Date:10/26/2009

strointestinal (GI) ulcer and/or prohibitive toxicity. Results showed that patients with mild-to-moderate pain treated with HZT-501 developed approximately 50 percent fewer NSAID-associated upper GI ulcers compared to patients treated with ibuprofen alone.

The statistical analysis looked at the combined 1,382 patients studied in the REDUCE-1 and REDUCE-2 primary study populations (HZT-501, N=930; ibuprofen, N=452). The predefined population for primary analyses of upper GI ulcers was all patients with at least one on-study endoscopy (EGD). The life table analysis estimate showed that fewer patients taking HZT-501 developed upper GI ulcers than those taking ibuprofen alone after 24 weeks (14.1% vs. 26.5%, p<0.0001). A multivariable proportional hazard regression analysis was done to assess potential risk factors for upper GI ulcer development in the combined studies. The following chart highlights the most prevalent risk factors derived from the analysis:



                   Analysis Factor                Relative Risk (95% CI)
                   ---------------                ---------------------
           Ibuprofen (without famotidine)           2.18 (1.64, 2.90)

                     Prior ulcer                    1.65 (1.01, 2.69)

                      Age >=65                      1.54 (1.10, 2.17)

                  Low-dose aspirin                  1.46 (1.00, 2.11)

                       Female                       1.15 (0.84, 1.57)

       Baseline erosions (GI erosions noted on
        baseline endoscopy at the start of the
        study)                                      1.15 (0.82, 1.62)


"By identifying these independent risk factors, physicians may be able to better assess a patient's risk for NSAID-associated GI toxicity," said Timothy P. Walbert, president and chief executive officer of Horizon Therapeutics. "For patients with chronic pain who are at increased GI risk, HZT-501 may be an importan
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SOURCE Horizon Therapeutics, Inc.
Copyright©2009 PR Newswire.
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Related medicine technology :

1. Horizon Therapeutics HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain
2. Boston Scientific Welcomes Publication of HORIZONS AMI Trial Results in New England Journal of Medicine
3. Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
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