A Double-Blind, Controlled, Crossover Trial of Amlodipine on Iron Overload Status in Transfusion Dependent ꞵ-Thalassemia Patients

Pediatric Hematology Oncology, Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Pharmaceutical Research Center, Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Department of Research, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Department of Cardiology, Mazandaran University of Medical Sciences, Faculty of Medicine, Sari, Mazandaran, Iran. Pediatric Endocrinology, Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Medical Microbiology, Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Student of Medical Surgical Nursing, Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.

International journal of clinical practice. 2021;:e14337
Abstract
BACKGROUND AND AIM This study examined whether administration of amlodipine could improve myocardial iron loading status in patients with transfusion dependent β-thalassemia (TDT), through a placebo-controlled, crossover study. METHODS Amlodipine (5 mg, daily) or placebo were prescribed to all patients (n = 19) for 6 months, and after a 2-week washout period, patients were crossed over to the other group. The efficacy of amlodipine on iron loading was assessed by measuring myocardial T2*-weighted magnetic resonance imaging (MRI T2*, millisecond [ms]) and serum ferritin (ng/mL). RESULTS Seventeen patients completed the study. The mean ± standard deviation [SD] of myocardial MRI T2* at baseline was 9.83 ± 2.67 ms. Myocardial MRI T2* value rose to 11.44 ± 4.14 ms post amlodipine treatment in all patients. After placebo, myocardial MRI T2* value reached 10.29 ± 4.01 ms. After controlling the baseline measures, Hedges's g for ferritin and myocardial MRI T2* outcomes were estimated 3.84 (95% confidence interval [CI] 2.68 to 4.97) and -1.80 (95% CI -2.58 -0.10), respectively. CONCLUSION Amlodipine might improve myocardial MRI T2* and serum ferritin level compared to placebo. However, larger clinical studies are needed to confirm the results.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine