Study Looks At Cardiac Iron Removal with Exjade

December 1, 2010 – A study published ahead of print in the journal Haematologica presents data indicating that the oral chelator deferasirox (Exjade) is effective at removing iron from the hearts of patients with thalassemia.

The study (“Continued improvement in myocardial T2* over 2 years of deferasirox treatment in β-thalassemia major patients with cardiac iron overload”) is an extension of an earlier study, which looked at cardiac iron as determined by T2* measurements over a one year period. This latest study follows 101 of those patients for a second year. All patients involved in the study had baseline T2* readings indicating the presence of myocardial iron in amounts greater than desired. 39 patients had baseline T2* scores >5 and <10 ms, indicating severe iron loading; 62 had baseline score between 10 and <20, indicating moderate to mild iron loading. (Patients with the most severe iron levels, T2* less than 5 msec, were not studied in this clinical trial).

The study authors state that “myocardial iron improved significantly,” with an overall mean relative increase of 17.7% in the first year and 36.8% in the second. In addition, “significant increases in myocardial T2* were noted both in the subgroup with severe myocardial iron overload…and in the subgroup with moderate-to-mild myocardial iron overload,” with the severe group going from 7.3 ms to 8.7 ms and the moderate-to-mild group going from 14.7 to 20.1.

Improvement was seen in 75.8% of the patients; no change was seen in 9.5%; and worsening was seen in 14.7%. In the moderate to mild group, 56.7% of patients achieved a normal myocardial T2* (> or = 20 ms). Serum ferritins and liver iron also decreased over the 2 years of the study.

In terms of LVEF (Left Ventricular Ejection Fraction), no improvement was observed. This might be due to initial exclusion of patients with poor heart function.

The original study has been extended another year, which will eventually provide data on cardiac iron response to deferasirox over a 3-year period.

Study authors are Dudley J. Pennell, John B. Porter, Maria Domenica Cappellini, Lee Lee Chan, Amal El-Beshlawy, Yesim Aydinok, Hishamshah Ibrahim, Chi-Kong Li, Vip Viprakasit, Mohsen Saleh Elalfy, Antonis Kattamis, Gillian Smith, Dany Habr, Gabor Domokos, Bernard Roubert, and Ali Taher.

This study was sponsored by Novartis Pharma AG.

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