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    Continued Improvement and Normalization of Myocardial T2*In Patients with beta-thalassemia Major Treated With Deferasirox (Exjade (R)) for up to 3 Years
    (Amer Soc Hematology, 2010) Pennell, Dudley; Porter, John B.; Cappellini, Maria Domenica; Chan, Lee Lee; El-Beshlawy, Amal; Aydinok, Yesim; Ibrahim, Hishamshah; Li, Chi-Kong; Viprakasit, Vip; Elalfy, Mohsen Saleh; Kattamis, Antonis; Smith, Gillian; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Taher, Ali
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    Continued improvement in myocardial T2(star) over two years of deferasirox therapy in beta-thalassemia major patients with cardiac iron overload
    (Ferrata Storti Foundation, 2011) Pennell, Dudley J.; Porter, John B.; Cappellini, Maria Domenica; Chan, Lee Lee; El-Beshlawy, Amal; Aydinok, Yesim; Ibrahim, Hishamshah; Li, Chi-Kong; Viprakasit, Vip; Elalfy, Mohsen Saleh; Kattamis, Antonis; Smith, Gillian; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Taher, Ali
    Background The efficacy of cardiac iron chelation in transfusion-dependent patients has been demonstrated in one-year prospective trials. Since normalization of cardiac T2* takes several years, the efficacy and safety of deferasirox was assessed for two years in patients with beta-thalassemia major in the cardiac sub-study of the EPIC trial. Design and Methods Eligible patients with myocardial T2* greater than 5 to less than 20 ms received deferasirox, with the primary endpoint being the change in T2* from baseline to two years. Results Baseline myocardial T2* was severe (>5 to <10 ms) in 39 patients, and moderate-to-mild (10 to <20 ms) in 62 patients. Mean deferasirox dose was 33.1+/-3.7 mg/kg/d in the one-year core study increasing to 36.1+/-7.7 mg/kg/d during the second year of treatment. Geometric mean myocardial T2* increased from a baseline of 11.2 to 14.8 ms at two years (P<0.001). In patients with moderate-to-mild baseline T2*, an increase was seen from 14.7 to 20.1 ms, with normalization (20 ms) in 56.7% of patients. In those with severe cardiac iron overload at baseline, 42.9% improved to the moderate-to-mild group. The incidence of drug-related adverse events did not increase during the extension relative to the core study and included (>= 5%) increased serum creatinine, rash and increased alanine aminotransferase. Conclusions Continuous treatment with deferasirox for two years with a target dose of 40 mg/kg/d continued to remove iron from the heart in patients with beta-thalassemia major and mild, moderate and severe cardiac siderosis. (Clinicaltrials.gov identifier: NCT 00171821)
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    Efficacy and Safety of Deferasirox (Exjade (R)) in beta-Thalassemia Patients with Myocardial Siderosis: 2-Year Results From the EPIC Cardiac Sub-Study
    (Amer Soc Hematology, 2009) Pennell, Dudley J.; Porter, John B.; Cappellini, M. Domenica; Chan, Lee Lee; El-Beshlawy, Amal; Aydinok, Yesim; Ibrahim, Hishamshah; Li, Chi-Kong; Viprakasit, Vip; Elalfy, Mohsen Saleh; Kattamis, Antonis; Smith, Gillian; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Taher, Ali
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    Efficacy and Safety of Deferasirox (Exjade (R)) in beta-Thalassemia Patients with Myocardial Siderosis: 2-Year Results From the EPIC Cardiac Sub-Study
    (Amer Soc Hematology, 2009) Pennell, Dudley J.; Porter, John B.; Cappellini, M. Domenica; Chan, Lee Lee; El-Beshlawy, Amal; Aydinok, Yesim; Ibrahim, Hishamshah; Li, Chi-Kong; Viprakasit, Vip; Elalfy, Mohsen Saleh; Kattamis, Antonis; Smith, Gillian; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Taher, Ali
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    Efficacy and Safety of Deferasirox (Exjade (R)) in Preventing Cardiac Iron Overload in beta-Thalassemia Patients with Normal Baseline Cardiac Iron: Results from the Cardiac Substudy of the EPIC Trial
    (Amer Soc Hematology, 2008) Pennell, Dudley; Sutcharitchan, Prance; El-Beshlawy, Amal; Aydinok, Yesim; Taher, Ali; Smith, Gillian; Habr, Dany; Kriemler-Krahn, Ulrike; Hmissi, Abdel; Porter, John B.
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    Efficacy and Safety of Deferasirox (Exjade (R)) in Reducing Cardiac Iron in Patients with beta-Thalassemia Major: Results from the Cardiac Substudy of the EPIC Trial
    (Amer Soc Hematology, 2008) Pennell, Dudley; Porter, John B.; Cappellini, Maria Domenica; Li, Chi-Kong; Aydinok, Yesim; Lee, Chan Lee; Kattamis, Antonis; Smith, Gillian; Habr, Dany; Domokos, Gabor; Hmissi, Abdel; Taher, Ali
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    Efficacy of deferasirox in reducing and preventing cardiac iron overload in beta-thalassemia
    (Amer Soc Hematology, 2010) Pennell, Dudley J.; Porter, John B.; Cappellini, Maria Domenica; El-Beshlawy, Amal; Chan, Lee Lee; Aydinok, Yesim; Elalfy, Mohsen Saleh; Sutcharitchan, Pranee; Li, Chi-Kong; Ibrahim, Hishamshah; Viprakasit, Vip; Kattamis, Antonis; Smith, Gillian; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Taher, Ali
    Cardiac iron overload causes most deaths in beta-thalassemia major. The efficacy of deferasirox in reducing or preventing cardiac iron overload was assessed in 192 patients with beta-thalassemia in a 1-year prospective, multicenter study. The cardiac iron reduction arm (n = 114) included patients with magnetic resonance myocardial T2* from 5 to 20 ms (indicating cardiac siderosis), left ventricular ejection fraction (LVEF) of 56% or more, serum ferritin more than 2500 ng/mL, liver iron concentration more than 10 mg Fe/g dry weight, and more than 50 transfused blood units. The prevention arm (n = 78) included otherwise eligible patients whose myocardial T2* was 20 ms or more. The primary end point was the change in myocardial T2* at 1 year. In the cardiac iron reduction arm, the mean deferasirox dose was 32.6 mg/kg per day. Myocardial T2* (geometric mean +/- coefficient of variation) improved from a baseline of 11.2 ms (+/- 40.5%) to 12.9 ms (+/- 49.5%) (+ 16%; P < .001). LVEF (mean +/- SD) was unchanged: 67.4 (+/- 5.7%) to 67.0 (+/- 6.0%) (-0.3%; P = .53). In the prevention arm, baseline myocardial T2* was unchanged from baseline of 32.0 ms (+/- 25.6%) to 32.5 ms (+/- 25.1%) (+ 2%; P = .57) and LVEF increased from baseline 67.7 (+/- 4.7%) to 69.6 (+/- 4.5%) (+ 1.8%; P < .001). This prospective study shows that deferasirox is effective in removing and preventing myocardial iron accumulation. This study is registered at http://clinicaltrials.gov as NCT00171821. (Blood. 2010; 115: 2364-2371)