A randomized, controlled study evaluating effects of amlodipine addition to chelators to reduce iron loading in patients with thalassemia major

Eur J Haematol. 2017 Dec;99(6):577-581. doi: 10.1111/ejh.12977. Epub 2017 Oct 13.

Abstract

Aim: Cardiomyopathy due to iron overload can be fatal in patients with thalassemia major. Calcium channel blockers seem to be effective to reduce iron loading. Our goal was to study effects of amlodipine addition to chelators on iron loading in patients with thalassemia major.

Methods: This randomized, controlled, and single-center trial was performed on 56 patients with thalassemia major. Patients were randomized 1:1 to combined group (iron chelator plus amlodipine) or control group (iron chelator) for 1 year. Iron content was measured by magnetic resonance imaging; heart T2*, and liver T2*. Serum ferritin was also measured.

Results: After 12 months of treatment, myocardial T2* values had significant improvement in combined group (21.9 ± 8.0 ms to 24.5 ± 7.6 ms; P < .05); Difference between two groups was significant (P = .02). Combined treatment had no effect on hepatic T2* value (9.6 ± 2.8 ms to 9.5 ± 3.6 ms); difference between two groups was not significant (P = .2). In addition, a significant reduction was seen in serum ferritin levels in two groups. Mild gastrointestinal upset was the most common untoward effect.

Conclusion: Addition of amlodipine to iron chelators has beneficial effects for reduction of iron loading in patients with thalassemia major. This combination therapy seems safe.

Keywords: amlodipine; cardiomyopathy; chelation; thalassemia.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Amlodipine / therapeutic use*
  • Biomarkers
  • Cardiomyopathies / diagnosis
  • Cardiomyopathies / drug therapy
  • Cardiomyopathies / etiology
  • Chelation Therapy
  • Child
  • Drug Therapy, Combination
  • Female
  • Ferritins / blood
  • Humans
  • Iron Chelating Agents / therapeutic use*
  • Iron Overload / diagnosis
  • Iron Overload / drug therapy*
  • Iron Overload / etiology*
  • Liver / metabolism
  • Liver / pathology
  • Male
  • Middle Aged
  • Time Factors
  • Treatment Outcome
  • Young Adult
  • beta-Thalassemia / complications*

Substances

  • Biomarkers
  • Iron Chelating Agents
  • Amlodipine
  • Ferritins