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

AimCardiomyopathy 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. MethodsThis 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 1year. Iron content was measured by magnetic resonance imaging; heart T2*, and liver T2*. Serum ferritin was also measured. ResultsAfter 12months of treatment, myocardial T2* values had significant improvement in combined group (21.98.0ms to 24.5 +/- 7.6ms; P<.05); Difference between two groups was significant (P=.02). Combined treatment had no effect on hepatic T2* value (9.6 +/- 2.8ms to 9.5 +/- 3.6ms); 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. ConclusionAddition of amlodipine to iron chelators has beneficial effects for reduction of iron loading in patients with thalassemia major. This combination therapy seems safe.