Exjade(R) Benefits Chronically Transfused Patients by Significantly Reducing Toxic Iron That Can Damage Key Organs, According to Land...(e myocardial T2* was <10 milliseconds...),Health

Date:12/8/2008

e myocardial T2* was <10 milliseconds (ms) in 47 (41%) patients (considered severe cardiac iron overload) and 10-20 ms in 67 (59%) patients (considered mild to moderate). Mean baseline liver iron concentration (LIC) was 28.2 (plus or minus) 10.0 mg Fe/g dry weight (dw), median SF was 5235 ng/mL, and the mean amount of transfused blood in the year prior to study entry was 185 mL/kg.

Patients experienced a statistically significant increase in myocardial T2* indicating a decrease in myocardial iron content. Based on a geometric mean (plus or minus) coefficient of variation, change from baseline (11.2 ms (plus or minus) 40.5%) to 12.9 ms (plus or minus) 49.5% represents an increase by a factor of 1.16 from baseline (P<0.0001). Overall, 69.5% of patients taking Exjade had an improvement in T2* (>4% increase); there was no change in 14.3%; and worsening (>4% decrease) in 16.2% of patients. Left ventricular ejection fraction remained stable throughout the study. Additionally, LIC and SF levels (both indicators of total body iron) were significantly reduced from baseline by -6.6 (plus or minus) 9.9 mg Fe/g dw and -1257 ng/mL, respectively (P<0.0001). Four patients discontinued treatment due to adverse events. Most investigator-assessed drug-related adverse events were mild to moderate in severity; rash was the most common (13.2%). There is an ongoing one-year extension of this substudy.

The pre-planned subgroup analysis of the EPIC study included 341 patients with transfusion-dependent MDS and SF levels ¿1000 ng/mL, or SF <1000 ng/mL, but with a history of multiple transfusions (>20 transfusions or 100 mL/kg of red blood cells) and an R2 MRI-confirmed LIC >2 mg Fe/g dw. Overall, mean actual dose of Exjade over one year of treatment was 19.2 (plus or minus) 5.4 mg/kg/day. Based on the last observation carried forward statistical method, at one year, there was a significant reduction in median SF from ba
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SOURCE Novartis Pharmaceuticals Corporation Copyright©2008 PR Newswire. All rights reserved

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