A double‐blind, controlled, crossover trial of amlodipine on iron overload status in transfusion dependent β‐thalassemia patients

Karami, Hossein; Arjmandi, Hadiseh Khalilzadeh; Salehifar, Ebrahim; Darvishi‐Khezri, Hadi; Dabirian, Mojdeh; Kosaryan, Mehrnoush; Aliasgharian, Aily; Akbarzadeh, Rosetta; Aali, Raheleh Naeimayi; Nasirzadeh, Amirreza

doi:10.1111/ijcp.14337

Cited by 3 publications

(1 citation statement)

References 38 publications

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“…All outcomes were evaluated at 6 and 12 months, depending on which was reported in the study. The study (Karami et al 16 ) was a cross‐over study with two groups: The AP sequence and the PA sequence. In the AP sequence, amlodipine was used for 6 months, followed by a placebo for another 6 months.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and safety of calcium channel blockers in preventing cardiac siderosis in thalassemia patients: An updated meta‐analysis with trial sequential analysis

Soliman

Abdelaziz

Mouffokes

et al. 2023

European J of Haematology

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Objectives Iron overload in patients with thalassemia represents a serious complication by affecting numerous organ systems. This meta‐analysis aims to establish an evidence regarding the effect of amlodipine on cardiac iron overload in thalassemia patients. Methods We searched PubMed, Scopus, Web of Science, Cochrane Central, and EMBASE for all relevant randomized controlled trials (RCTs). The primary outcomes were cardiac T2* and myocardial iron concentration (MIC). Secondary outcomes were liver iron concentration (LIC), risk of Gastrointestinal (G.I.) upset and risk of lower limb edema. We used Hedges' g to pool continuous outcomes, while odds ratio was used for dichotomous outcomes. Results Seven RCTs were eligible for this systematic review and meta‐analysis, comprising of 233 patients included in the analysis. Amlodipine had a statistically significant lower MIC (Hedges' g = −0.82, 95% confidence interval [CI] [−1.40, −0.24], p < .001) and higher cardiac T2* (Hedges' g = 0.36, 95% CI [0.10, 0.62], p = .03). Amlodipine was comparable to standard chelation therapy in terms of the risk of lower limb edema and GI upset. Conclusion Our meta‐analysis found that amlodipine significantly increases cardiac T2* and decreases MIC, hence decreasing the incidence of cardiomyopathy‐related iron overload in thalassemia patients.

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Section: Methodsmentioning

confidence: 99%

Efficacy and safety of calcium channel blockers in preventing cardiac siderosis in thalassemia patients: An updated meta‐analysis with trial sequential analysis

Soliman

Abdelaziz

Mouffokes

et al. 2023

European J of Haematology

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Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia

Padhani,

Gangwani,

Sadaf

et al. 2023

Cochrane Database of Systematic Reviews

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Amlodipine Therapy in β-Thalassemia Patients: A Systematic Review and Meta-Analysis on Ferritin Levels and Liver MRI T2*

Aliasgharian,

Karami,

Zahedi

et al. 2023

Thalassemia Reports

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Background and aim: We conducted a review to determine the efficacy of amlodipine alongside iron chelators on serum ferritin levels and liver T2-weighted magnetic resonance imaging (MRI T2*) in β-thalassemia patients. Methods: Systematic search was conducted in multiple databases, including Web of Science, PubMed, Scopus, Embase, Cochrane Library, ClinicalTrials.gov, the Iranian Registry of Clinical Trials (IRCT), ProQuest, OpenGrey, and Web of Science Conference Proceedings Citation Index. The search was closed in January 2023. Primary outcomes were comprised of liver MRI T2* (millisecond (msec)) and serum ferritin levels (ng/mL). Results: Seven studies (n = 227) were included in the study. The pooled Cohen’s d for serum ferritin was estimated at −0.46, 95% confidence interval (CI) −1.11 to 0.19 and p = 0.16 (I2 86.23%, p < 0.0001). The pooled mean difference for serum ferritin was −366.44 ng/mL, 95% CI −844.94 to 112.05, and p = 0.13 (I2 81.63%, p < 0.0001). After a meta-regression based on the length of using amlodipine, a coefficient for the mean difference was also −23.23 ng/mL and 95% CI −155.21 to 108.75. The coefficient obtained from a meta-regression as per the amlodipine dose at 5 mg/day than 2.5 to 5 mg/day anchored at −323.49 ng/mL and 95% CI −826.14 to 1473.12. A meta-regression according to the baseline values of serum ferritin discovered a coefficient of 1.25 ng/mL and 95% CI 0.15 to 2.35. Based on two included studies (n = 96), the overall Cohen’s d for liver MRI T2* was 2.069, 95% CI −0.896 to 5.035, and p = 0.17 (I2 96.31%, p< 0.0001). The synthesized mean difference for liver MRI T2* was 8.76 msec, 95% CI −4.16 to 21.67, and p = 0.18 (I2 98.38%, p < 0.000). Conclusion: At a very low level of evidence, probably using amlodipine at a dose of 2.5 to 5 mg a day, up to a year, alongside iron chelators slightly decreases serum ferritin levels in iron-overloaded thalassemia cases by nearly 366 ng/mL (23 ng/mL per month). The liver MRI T2* might also rise to 8.76 msec upon co-therapy with amlodipine.

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A double‐blind, controlled, crossover trial of amlodipine on iron overload status in transfusion dependent β‐thalassemia patients

Cited by 3 publications

References 38 publications

Efficacy and safety of calcium channel blockers in preventing cardiac siderosis in thalassemia patients: An updated meta‐analysis with trial sequential analysis

Efficacy and safety of calcium channel blockers in preventing cardiac siderosis in thalassemia patients: An updated meta‐analysis with trial sequential analysis

Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia

Amlodipine Therapy in β-Thalassemia Patients: A Systematic Review and Meta-Analysis on Ferritin Levels and Liver MRI T2*

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