Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/325826
Type: Artigo
Title: A Randomized Trial Of Amlodipine In Addition To Standard Chelation Therapy In Patients With Thalassemia Major
Author: Fernandes
Juliano L.; Loggetto
Sandra R.; Verissimo
Monica P. A.; Fertrin
Kleber Y.; Baldanzi
Giorgio R.; Fioravante
Luciana A. B.; Tan
Doralice M.; Higa
Tatiana; Mashima
Denise A.; Piga
Antonio; Coelho
Otavio R.; Costa
Fernando F.; Saad
Sara T.
Abstract: Cardiovascular disease resulting from iron accumulation is still a major cause of death in patients with thalassemia major (TM). Voltage-gated calcium-channel blockade prevents iron entry into cardiomyocytes and may provide an adjuvant treatment to chelation, reducing myocardial iron uptake. We evaluated whether addition of amlodipine to chelation strategies would reduce myocardial iron overload in TM patients compared with placebo. In a multicenter, double-blind, randomized, placebo-controlled trial, 62 patients were allocated to receive oral amlodipine 5 mg/day or placebo in addition to their current chelation regimen. The main outcome was change in myocardial iron concentration (MIC) determined by magnetic resonance imaging at 12 months, with patients stratified into reduction or prevention groups according to their initial T2* below or above the normal human threshold of 35 ms (MIC, 0.59 mg/g dry weight). At 12 months, patients in the reduction group receiving amlodipine (n = 15) had a significant decrease in MIC compared with patients receiving placebo (n 5 15) with a median of -0.26 mg/g (95% confidence interval, -1.02 to -0.01) vs 0.01 mg/g (95% confidence interval, -0.13 to 0.23), P = .02. No significant changes were observed in the prevention group (treatment-effect interaction with P = .005). The same findings were observed in the subgroup of patients with T2* <20 ms. Amlodipine treatment did not cause any serious adverse events. Thus, in TM patients with cardiac siderosis, amlodipine combined with chelation therapy reduced cardiac iron more effectively than chelation therapy alone. Because this conclusion is based on subgroup analyses, it needs to be confirmed in ad hoc clinical trials. This trial was registered at www.clinicaltrials.gov identifier as #NCT01395199.
Editor: Amer Soc Hematology
Washington
Rights: fechado
Identifier DOI: 10.1182/blood-2016-06-721183
Address: http://www-bloodjournal-org.ez88.periodicos.capes.gov.br/content/128/12/1555
Date Issue: 2016
Appears in Collections:Unicamp - Artigos e Outros Documentos

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