 516 patients enrolled in the study, 359 patients remained on DFO throughout the entire period, of which 14% developed a cardiac event, while none of the 157 patients who were switched to Ferriprox experienced a cardiac event.
Forty-six patients discontinued Ferriprox as a consequence of clinical or laboratory adverse events and 16 patients discontinued Ferriprox for reasons other than adverse events.
"Although DFO has been associated with a marked decrease in morbidity and mortality in chronically transfused patients, iron-induced cardiac disease continues to remain a serious problem," said Caterina Borgna-Pignatti, M.D., lead investigator, Clinica Pediatrica of the University of Ferrara. "These findings support previous research demonstrating that the introduction of Ferriprox has significantly reduced the incidence of cardiac disease and actually limits early deaths in thalassemia patients."
The first iron chelator in Europe, which can be given orally instead of by injection, was Ferriprox„§, approved in August 1999 as a second line therapy for patients with transfusion-dependent thalassemia. Since that time it has been used by thousands of patients in about 50 countries. Ferriprox (deferiprone) is administered in the range of 75-100 mg/kg/day in 3 equally divided doses and patients must be monitored weekly to detect early signs of a drop in white blood cells, secondary to agranulocytosis, which occurs in about 1% of patients. It works in conditions of iron overload, such as thalassemia, where frequent blood transfusions result in large deposits of iron in tissues, by binding to excess iron and removing it from the body, primarily in the urine. Effective chelation of iron in patients with iron overload decreases the risk of severe morbidity induced by excess iron in the tissues and prolongs survival as well. Full prescribing information is available from Apotex Inc.
ApoPharma is the innovative drug development member of the Canadian-owned Apotex Group of Companies. ApoPharma is developing medications primarily in the fields of Iron Chelation and Wound Healing. Iron Chelation development has focused primarily in conditions of Iron Overload, such as thalassemia. Development in the field of Wound Healing has focused on the treatment of hard to heal wounds, such as those found in diabetic patients, where a proprietary product in final stages of development is based on human fibroblasts that generate new skin. The Apotex Group of companies plans to spend a total of $1.3 billion over the next 10 years on research and development.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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