星期三 [ 2010-7-21 22:47:54 | watches2010 ]   Real-World Experience Confirms Japan PASS interim results presented at Hemophilia 2010 World Congress BUENOS AIRES, Argentina -- Baxter International Inc. (NYSE: BAX) today announced final E.U./U.S. post-authorization safety surveillance (PASS) data that support the Sexy Costumes safety and efficacy profile of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] previously documented in prospective clinical trials in a new study published in the journal Haemophilia.1 Similar safety, inhibitor profile and efficacy were seen in previously treated patients (PTPs) with severe to moderately severe hemophilia A as well as across a broad range of hemophilia patients in everyday practice. The results are from the large, prospective, open-label, observational study examining 521 patients of any age and with severe to moderately severe hemophilia A who were treated prophylactically (preventatively) or on-demand (as needed) with ADVATE therapy at the discretion of the participating physicians in the United States and 11 countries in the European Union. In PTPs with severe to moderately severe hemophilia A (n=348), the inhibitor rate was 0.29 percent (95 percent confidence interval [CI] of 0.01 to 1.59 percent). This is comparable with the 0.51 percent (95 percent CI of 0.03 to 2.91 percent) inhibitor rate seen in the ADVATE clinical study in a similar but somewhat smaller group of patients (n=198). Additionally, interim results from the Japan PASS registry were presented at the Hemophilia 2010 World Congress of the World Federation of Hemophilia. Actual practice patterns in Japan have not been well documented. Japan PASS enrollment data presented at the Congress examined ADVATE treatment regimens among different age groups of people with hemophilia A, demonstrating a higher tendency for prophylactic use among younger patients, with a decrease in prophylactic use in patients older than 20 years of age. 鈥?9mportantly, the E.U./U.S. PASS data confirm patients on ADVATE, particularly those with previous exposure to factor VIII products, had a low risk of developing an inhibitor, the management of which remains the greatest challenge for physicians and patients with hemophilia A today,鈥? said investigator Johannes Oldenburg, M.D., Ph.D., head, Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Germany. 鈥?4he data from the large registry involving a broad population of patients with hemophilia A are important because they corroborate the safety, immunogenicity profile and efficacy of ADVATE in real-world practice.鈥? Overall, the PASS registry confirmed the ADVATE therapy safety profile established in controlled clinical studies. No unusual or unexpected adverse events were observed in PASS. Ten serious adverse events were considered related to ADVATE therapy, and included factor VIII (FVIII) inhibitor development, hypersensitivity and decreased drug effect. Ten non-serious adverse events were considered related to ADVATE. These included abdominal pain, abnormal skin odor, Replica IWC Watches abnormal urine odor, psychomotor hyperactivity, asthenia, headache, fatigue, decreased drug effect and anxiety. 鈥?0ASS registries allow for an evaluation of broader patient experiences with ADVATE under conditions of routine clinical practice in the general hemophi Wow gold!: Wow gold Wow gold 浏览(44) | 回复(0) |