Cardiac effects of deferasirox in transfusion‐dependent patients with myelodysplastic syndromes: TELESTO study

Author:

Sarocchi Matteo1,Li Junmin2ORCID,Li Xiao3ORCID,Wu Depei4,Montaño Figueroa Efreen5,Rodriguez Maria Guadalupe6,Hou Ming7,Finelli Carlo8,Shi Hong‐Xia9,Xiao Zhijian10,Oliva Esther Natalie11,Gercheva Kyuchukova Liana12,Drummond Mark13,Symeonidis Argiris14ORCID,Velazquez Eric J.15,Rivoli Giulia16,Izquierdo Miguel17,Kolekar Yogita18,Spallarossa Paolo1,Angelucci Emanuele16ORCID

Affiliation:

1. Cardiovascular Disease Unit IRCCS Ospedale Policlinico San Martino Genova Italy

2. School of Medicine, Ruijin Hospital Shanghai Jiao Tong University Shanghai China

3. Shanghai Sixth People's Hospital Shanghai China

4. Jiangsu Institute of Hematology First Affiliated Hospital of Suzhou University Suzhou China

5. Department of Hematology Hospital General de México Dr Eduardo Liceaga Mexico City Mexico

6. Department of Hematology Hospital de Especialidades, Centro Médico Nacional La Raza, IMSS Mexico City Mexico

7. Department of Hematology Qilu Hospital, Shandong University Jinan China

8. IRCCS Azienda Ospedaliero‐Universitaria di Bologna, Istituto di Ematologia “Seràgnoli” Bologna Italy

9. Peking University People's Hospital Beijing China

10. Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Tianjin China

11. Hematology Unit Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy

12. Clinical Hematology Clinic, Multiprofile Hospital for Active Treatment “Sveta Marina” Varna Bulgaria

13. Beatson West of Scotland Cancer Centre Glasgow UK

14. Hematology Division, Department of Internal Medicine University of Patras Medical School Patras Greece

15. Yale School of Medicine Yale University New Haven Connecticut USA

16. Hematology and Cellular Therapy, IRCCS Ospedale Policlinico San Martino Genova Italy

17. Novartis Pharma AG Basel Switzerland

18. Novartis Healthcare Private Limited Hyderabad India

Abstract

SummaryIron overload from repeated transfusions has a negative impact on cardiac function, and iron chelation therapy may help prevent cardiac dysfunction in transfusion‐dependent patients with myelodysplastic syndromes (MDS). TELESTO (NCT00940602) was a prospective, placebo‐controlled, randomised study to evaluate the iron chelator deferasirox in patients with low‐ or intermediate‐1–risk MDS and iron overload. Echocardiographic parameters were collected at screening and during treatment. Patients receiving deferasirox experienced a significant decrease in the composite risk of hospitalisation for congestive heart failure (CHF) or worsening of cardiac function (HR = 0.23; 95% CI: 0.05, 0.99; nominal p = 0.0322) versus placebo. No significant differences between the arms were found in left ventricular ejection fraction, ventricular diameter and mass or pulmonary artery pressure. The absolute number of events was low, but the enrolled patients were younger than average for patients with MDS, with no serious cardiac comorbidities and a modest cardiovascular risk profile. These results support the effectiveness of deferasirox in preventing cardiac damage caused by iron overload in this patient population. Identification of patients developing CHF is challenging due to the lack of distinctive echocardiographic features. The treatment of iron overload may be important to prevent cardiac dysfunction in these patients, even those with moderate CHF risk.

Funder

Novartis Pharmaceuticals Corporation

Publisher

Wiley

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