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

Cochrane Database of Systematic Reviews

Volumn 2018, Issue 7, 2018, Pages

  Sadaf, Alina ^a   Hasan, Babar ^b   Das, Jai K ^b   Colan, Steven ^c   Alvi, Najveen ^d  

^a UNIVERSITY OF FLORIDA   (United States)

^b AGA KHAN UNIVERSITY HOSPITAL   (Pakistan)

^c BOSTON CHILDREN S HOSPITAL   (United States)

^d AGA KHAN UNIVERSITY   (Pakistan)

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE; BRAIN NATRIURETIC PEPTIDE; CALCIUM CHANNEL BLOCKING AGENT; FERRITIN; IRON;

ADVERSE EVENT; BETA THALASSEMIA; BLOOD TRANSFUSION; CARDIAC MUSCLE; CARDIOMYOPATHY; CARDIOVASCULAR MAGNETIC RESONANCE; CONCENTRATION (PARAMETERS); DISEASE SEVERITY; DRUG EFFECT; ECHOCARDIOGRAPHY; EXERCISE TEST; FERRITIN BLOOD LEVEL; HEART ARRHYTHMIA; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART LEFT VENTRICLE FILLING PRESSURE; HEART PROTECTION; HEART VENTRICLE VOLUME; HUMAN; INCIDENCE; IRON CHELATION; IRON OVERLOAD; LIVER LEVEL; MORBIDITY; MORTALITY; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; SYSTEMATIC REVIEW; TREATMENT OUTCOME; ADOLESCENT; ADULT; BLOOD; BLOOD TRANSFUSION REACTION; CHELATION THERAPY; CHEMISTRY; CHILD; COMPLICATION; FEMALE; LIVER; MULTIMODALITY CANCER THERAPY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); TIME FACTOR; YOUNG ADULT;

ADOLESCENT; ADULT; AMLODIPINE; BETA-THALASSEMIA; BLOOD TRANSFUSION; CALCIUM CHANNEL BLOCKERS; CARDIOMYOPATHIES; CHELATION THERAPY; CHILD; COMBINED MODALITY THERAPY; FEMALE; FERRITINS; HUMANS; IRON; IRON OVERLOAD; LIVER; MYOCARDIUM; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; TRANSFUSION REACTION; YOUNG ADULT;

EID: 85049863395     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD011626.pub2     Document Type: Review

References (89)

1. Fernandes JL, Sampaio EF, Fertrin K, Coelho OR, Logetto S, Piga A, et al. Amlodipine reduces cardiac iron overload in patients with thalassemia major: a pilot trial. American Journal of Medicine 2013;126:834-7. [CFGD Register: TH148]8758351
2. Fernandes JL, Loggetto SR, Veríssimo MPA, Fertrin KY, Baldanzi GR, Fioravante LAB, et al. A randomised trial of amlodipine in addition to standard chelation therapy in patients with thalassemia major. Blood 2016;128(12):1555-61. [DOI: 10.1182/blood-2016-06-721183; PUBMED: 27412888 ]8758353
3. Cappellini MD, Cohen A, Piga A, Bejaoui M, Perrotta S, Agaoglu L, et al. A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. Blood 2006;107(9):3455-62. 8758355
4. Chirnomas D, Smith AL, Braunstein J, Finkelstein Y, Pereira L, Bergmann AK, et al. Deferasirox pharmacokinetics in patients with adequate versus inadequate response. Blood 2009;114(19):4009-13. 8758357
5. Lai ME, Grady RW, Vacquer S, Pepe A, Carta MP, Bina P, et al. Increased survival and reversion of iron-induced cardiac disease in patients with thalassemia major receiving intensive combined chelation therapy as compared to desferoxamine alone. Blood Cells, Molecules and Diseases 2010;45(2):136-9. 8758359
6. NCT00115349. Combination therapy compared with single-drug therapy in patients with cardiac diseases [Thalassemia clinical research network - Cardiac L1/DFO Trial]. clinicaltrials.gov/ct2/show/NCT00115349 Date first received: 21 June 2005. 8758361
7. NCT00712738. Oral nifedipine to treat iron overload [A trial of oral nifedipine for the treatment of iron overload]. clinicaltrials.gov/ct2/show/NCT00712738 Date first received: 09 July 2008. 8758363
8. NCT01927913. Treatment of iron overload requiring chelation therapy [A 48-week, open-label, 2-arm, parallel-group, randomised exploratory study to assess liver iron concentration measured by FerriScan® (R2) magnetic resonance imaging in B-thalassemia subjects administered SPD602 (SSP-004184AQ) or Exjade® (Deferasirox) for treatment of chronic transfusional iron overload]. clinicaltrials.gov/ct2/show/NCT01927913 Date first received: 20 August 2013. 8758365
9. NCT02173951. An algorithm to start iron chelation in minimally transfused young beta-thalassemia major patients [A decisional algorithm to start iron chelation in minimally transfused young beta-thalassemia major patients naive to iron chelation therapy. A comparative randomised prospective Study]. clinicaltrials.gov/ct2/show/NCT02173951 Date first received: 23 June 2014. 8758367
10. El-Haggar, SM. Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia. www.clinicaltrials.gov Date first received: 2 February, 2016. 8758369
11. Neufeld EJ, Galanello R, Viprakasit V, Aydinok Y, Piga A, Harmatz P, et al. A phase 2 study of the safety, tolerability, and pharmacodynamics of FBS0701, a novel oral iron chelator, in transfusional iron overload. Blood 2012;119(14):3263-8. 8758371
12. Alvi N, Tipoo F, Rizvi A, Fadoo Z, Imran A, Sadaf A, et al. Effect of L-type calcium channel blocker (amlodipine) on myocardial iron deposition in patients with thalassemia major: a randomised control trial. Haematologica. Conference: 21st congress of the European Hematology Association. Denmark 2016;101(S1):848-9. [CFGD Register: TH137b]8758373
13. Shakoor A, Zahoor M, Sadaf A, Alvi N, Fadoo Z, Rizvi A, et al. Effect of L-type calcium channel blocker (amlodipine) on myocardial iron deposition in patients with thalassaemia with moderate-to-severe myocardial iron deposition: protocol for a randomised, controlled trial. BMJ (Clinical Research Ed.) 2014;4(12):e005360. [CENTRAL: 1051146; CFGD Register: TH137a; CRS: 5500133000000011; JID:: 101552874; PMCID:: PMC4265146; PUBMED: 25492271]8758374
14. Shakoor A, Zahoor M, Sadaf A, Alvi N, Fadoo Z, Rizvi A, et al. Effect of L-type calcium channel blocker (amlodipine) on myocardial iron deposition in patients with thalassaemia with moderate-to-severe myocardial iron deposition: protocol for a randomised, controlled trial. BMJ Open 2014; Vol. 4:e005360. [DOI: 10.1136/bmjopen-2014-005360]8758375
15. NCT02474420. Amlodipine as adjuvant treatment to iron chelation for prevention of cardiac iron overload in thalassemia patients (CANALI) [The use of the calcium channel blocker amlodipine as an adjuvant treatment to iron chelation for the prevention of iron overload cardiomyopathy in patients with thalassemia]. clinicaltrials.gov/ct2/show/NCT02474420 Date first received: 11 June 2015. 8758377
16. Alpendurada F, Smith GC, Carpenter JP, Nair SV, Tanner MA, Banya W, et al. Effects of combined deferiprone with deferoxamine on right ventricular function in thalassaemia major. Journal of Cardiovascular Magnetic Resonance 2012;14:8.
17. Alwan A, Modell B. Community control of genetic and congenital disorders. Eastern Mediterranean region office technical publication series 24. Alexandria, VA: World Health Organization, 1997.
18. Anderson LJ, Holden S, Davis B, Prescott E, Charrier CC, Bunce NH, et al. Cardiovascular T2-star (T2*) magnetic resonance for the early diagnosis of myocardial iron overload. European Heart Journal 2001;22(23):2171-9.
19. Angastiniotis M, Corrons JLV, Soteriades ES, Eleftheriou A. The impact of migrations on the health services for rare diseases in Europe: the example of haemoglobin disorders. Scientific World Journal 2013;2013:Article ID: 727905. [DOI: 10.1155/2013/727905]
20. Borgna-Pignatti C, Rugolotto S, De Stefano P, Zhao H, Cappellini MD, Del Vecchio GC, et al. Survival and complications in patients with thalassaemia major treated with transfusion and deferoxamine. Haematologica 2004;89(10):1187-93.
21. Borgna-Pignatti C, Meloni A, Guerrini G, Gulino L, Filosa A, Ruffo GB, et al. Myocardial iron overload in thalassaemia major. How early to check?. British Journal of Haematology 2014;164(4):579-85.
22. Buja LM, Roberts WC. Iron in the heart: etiology and clinical significance. American Journal of Medicine 1971;51(2):209-21.
23. Cao A, Galanello R. Effect of consanguinity on screening for thalassemia. New England Journal of Medicine 2002;347:1200-2.
24. Cappellini MD, Bejaoui M, Agaoglu L, Porter J, Coates T, Jeng M, et al. Prospective evaluation of patient-reported outcomes during treatment with deferasirox or deferoxamine for iron overload in patients with beta-thalassemia. Clinical Therapeutics 2007;29(5):909-17.
25. Carpenter JP, He T, Kirk P, Roughton M, Anderson LJ, de Noronha SV, et al. On T2* magnetic resonance and cardiac iron. Circulation 2011;123(14):1519-28.
26. Cassinerio E, Roghi A, Pedrotti P, Brevi F, Zanaboni L, Graziadei G, et al. Cardiac iron removal and functional cardiac improvement by different iron chelation regimens in thalassemia major patients. Annals of Hematology 2012;91(9):1443-9.
27. Charafeddine K, Isma'eel H, Charafeddine M, Inati A, Koussa S, Naja M, et al. Survival and complications of beta-thalassaemia in Lebanon: a decade's experience of centralized care. Acta Haematologica 2008;120(2):112-6. [DOI: 10.1159/000171088]
28. Cohen AR, Galanello R, Piga A, De Sanctis V, Tricta F. Safety and effectiveness of long-term therapy with the oral iron chelator deferiprone. Blood 2003;102(5):1583-7.
29. Donner A, Klar N. Issues in the meta-analysis of cluster randomised trials. Statistics in Medicine 2002;21(19):2071-80.
30. Eaton JW, Qian M. Molecular bases of cellular iron toxicity. Free Radical Biology & Medicine 2002;32(9):833-40.
31. Egstrup K, Andersen PE. Transient myocardial ischaemia during nifedipine therapy in stable angina pectoris, and its relation to coronary collateral flow and comparison with metoprolol. American Journal of Cardiology 1993;71(2):177-83.
32. Elbourne DR, Altman DG, Higgins JP, Curtin F, Worthington HV, Vail A. Meta-analyses involving cross-over trials: methodological issues. International Journal of Epidemiology Feb 2002;31(1):140-9.
33. Engle MA, Erlandson M, Smith CH. Late cardiac complications of chronic, severe, refractory anaemia with haemochromatosis. Circulation 1964;30:698-705.
34. Ferguson DW, Hayes DW. Nifedipine potentiates cardiopulmonary baroreflex control of sympathetic nerve activity in healthy humans: direct evidence from microneurographic studies. Circulation 1989;80(2):285-98.
35. Fisher SA, Brunskill SJ, Doree C, Gooding S, Chowdhury O, Roberts DJ. Desferrioxamine mesylate for managing transfusional iron overload in people with transfusion-dependent thalassaemia. Cochrane Database of Systematic Reviews 2013, Issue 8. [DOI: 10.1002/14651858.CD004450.pub3]
36. Fisher SA, Brunskill SJ, Doree C, Chowdhury O, Gooding S, Roberts DJ. Oral deferiprone for iron chelation in people with thalassaemia. Cochrane Database of Systematic Reviews 2013, Issue 8. [DOI: 10.1002/14651858.CD004839.pub3]
37. Grace AA, Camm AJ. Voltage-gated calcium-channels and antiarrhythmic drug action. Cardiovascular Research 2000;45(1):43-51.
38. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490-4.
39. Guazzi MD, Polese A, Fiorentini C, Bartorelli A, Moruzzi P. Treatment of hypertension with calcium antagonists. Review. Hypertension 1983;5(4 Pt 2):1185-90.
40. Gujja P, Rosing DR, Tripodi DJ, Shizukuda Y. Iron overload cardiomyopathy: better understanding of an increasing disorder. Journal of the American College of Cardiology 2010;56(13):1001-12. [DOI: 10.1016/j.jacc.2010.03.083]
41. Henneman A, Thornby KA. Risk of hypotension with concomitant use of calcium-channel blockers and macrolide antibiotics. American Journal of Health-System Pharmacy 2012;69(12):1038-43.
42. Hershko C. Pathogenesis and management of iron toxicity in thalassaemia. Annals of the New York Academy of Sciences 2010;1202:1-9. [DOI: 10.1111/j.1749-6632.2010.05544.x]
43. Hider RC, Liu ZD. Emerging understanding of the advantage of small molecules such as hydroxypyridinones in the treatment of iron overload. Current Medicinal Chemistry 2003;10(12):1051-64.
44. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Statistics in Medicine 2002;21(11):1539-58.
45. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
46. Higgins JP, White IR, Anzures-Cabrera J. Meta-analysis of skewed data: combining results reported on log-transformed or raw scales. Statistics in Medicine 2008;27(29):6072-92.
47. Higgins JPT, Deeks JJ, Altman DG on behalf of the Cochrane Statistical Methods Group, editor(s). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S, editor(s). Cochrane Handbook of Systematic Reviews of Interventions. Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
48. Kim E, Giri SN, Pessah IN. Iron(II) is a modulator of ryanodine-sensitive calcium channels of cardiac muscle sarcoplasmic reticulum. Toxicology and Applied Pharmacology 1995;130(1):57-66.
49. Kirk P, Roughton M, Porter JB, Walker JM, Tanner MA, Patel J, et al. Cardiac T2* magnetic resonance for prediction of cardiac complications in thalassemia major. Circulation 2009;120(20):1961-8.
50. Kirk P, Sheppard M, Carpenter J, Anderson L, He T, De Noronha S, et al. Fibrosis in cardiac siderosis: update on historical perspectives. Haematologica 2012;97 Suppl 1:382.
51. Kumfu S, Chattipakorn S, Chinda K, Fucharoen S, Chattipakorn N. T-type calcium channel blockade improves survival and cardiovascular function in thalassaemic mice. European Journal of Haematology 2012;88(6):535-48. [DOI: 10.1111/j.1600-0609.2012.01779.x]
52. Kumfu S, Chattipakorn S, Fucharoen S, Chattipakorn N. Ferric iron uptake into cardiomyocytes of β-thalassaemic mice is not through calcium channels. Drug and Chemical Toxicology 2013;36(3):329-34. [DOI: 10.3109/01480545.2012.726625]
53. Kwiatkowski JL. Real-world use of iron chelators. Hematology. American Society of Hematology, Education Program 2011;1:451-8. [DOI: 10.1182/asheducation-2011.1.451]
54. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009;339:b2700. [DOI: 10.1136/bmj.b2700]
55. Link G, Pinson A, Hershko C. Heart cells in culture: a model of myocardial iron overload and chelation. Journal of Laboratory and Clinical Medicine 1985;106(2):147-53.
56. Link G, Pinson A, Hershko C. Ability of the orally effective iron chelators dimethyl- and diethyl-hydroxypyrid-4-one and of deferoxamine to restore sarcolemmal thiolic enzyme activity in iron-loaded heart cells. Blood 1994;83(9):2692-7.
57. Link G, Konijn AM, Breuer W, Cabantchik ZI, Hershko C. Exploring the "iron shuttle" hypothesis in chelation therapy: effects of combined deferoxamine and deferiprone treatment in hypertransfused rats with labelled iron stores and in iron-loaded rat heart cells in culture. Journal of Laboratory and Clinical Medicine 2001;138(2):130-8.
58. Livrea MA, Tesoriere L, Pintaudi AM, Calabrese A, Maggio A, Freisleben HJ, et al. Oxidative stress and antioxidant status in beta-thalassaemia major: iron overload and depletion of lipid-soluble antioxidants. Blood 1996;88(9):3608-14.
59. Ludwiczek S, Theurl I, Muckenthaler MU, Jakab M, Mair SM, Theurl M, et al. Ca2+ channel blockers reverse iron overload by a new mechanism via divalent metal transporter-1. Nature Medicine 2007;13(4):448-54.
60. Maggio A, Vitrano A, Lucania G, Capra M, Cuccia L, Gagliardotto F, et al. Long-term use of deferiprone significantly enhances left-ventricular ejection function in thalassemia major patients. American Journal of Hematology 2012;87(7):732-3.
61. Meerpohl JJ, Antes G, Rücker G, Fleeman N, Motschall E, Niemeyer CM, et al. Deferasirox for managing iron overload in people with thalassaemia. Cochrane Database of Systematic Reviews 2017, Issue 8. [DOI: 10.1002/14651858.CD007476.pub3]
62. Modell B, Khan M, Darlison M. Survival in beta-thalassaemia major in the UK: data from the UK Thalassaemia Register. Lancet 2000;355(9220):2051-2.
63. Modell B, Darlison M, Birgens H, Cario H, Faustino P, Giordano PC, et al. Epidemiology of haemoglobin disorders in Europe: an overview. Scandinavian Journal of Clinical & Laboratory Investigation 2007;67(1):39-70.
64. Modell B, Darlison M. Global epidemiology of haemoglobin disorders and derived service indicators. Bulletin of the World Health Organization 2008;86:480-7.
65. Murphy CJ, Oudit GY. Iron-overload cardiomyopathy: pathophysiology, diagnosis, and treatment. Journal of Cardiac Failure 2010;16(11):888-900. [DOI: 10.1016/j.cardfail.2010.05.009]
66. Olivieri NF, Nathan DG, MacMillan JH, Wayne AS, Liu PP, McGee A, et al. Survival in medically treated patients with homozygous beta-thalassaemia. New England Journal of Medicine 1994;331(9):574-8.
67. Oudit GY, Sun H, Trivieri MG, Koch SE, Dawood F, Ackerley C, et al. L-type Ca2+ channels provide a major pathway for iron entry into cardiomyocytes in iron-overload cardiomyopathy. Nature Medicine 2003;9(9):1187-94.
68. Oudit GY, Trivieri MG, Khaper N, Liu PP, Backx PH. Role of L-type Ca2+ channels in iron transport and iron-overload cardiomyopathy. Journal of Molecular Medicine 2006;84(5):349-64.
69. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Statistics in Medicine 1998;17(24):2815-34.
70. Baksi AJ, Penell DJ. T2* imaging of the heart: methods, applications, and outcomes. Topics in Magnetic Resonance Imaging 2014;23(1):13-20.
71. Pepe A, Meloni A, Rossi G, Cuccia L, D'Ascola GD, Santodirocco M, et al. Cardiac and hepatic iron and ejection fraction in thalassemia major: multicentre prospective comparison of combined deferiprone and deferoxamine therapy against deferiprone or deferoxamine monotherapy. Journal of Cardiovascular Magnetic Resonance 2013;15(1):1. [DOI: 10.1186/1532-429X-15-1]
72. Rachmilewitz EA, Giardina PJ. How I treat thalassemia. Blood 2011;118(13):3479-88.
73. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
74. Rund D, Rachmilewitz E. Beta-thalassemia. New England Journal of Medicine 2005;353(11):1135-46.
75. Russell RP. Side effects of calcium channel blockers. Hypertension 1988;11:1142.
76. Schünemann HJ, Oxman AD, Higgins JPT, Vist GE, Glasziou P, Guyatt GH on behalf of the Cochrane Applicability and Recommendations Methods Group and the Cochrane Statistical Methods Group. Chapter 11: Presenting results and 'Summary of findings' tables. In: Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
77. Sica DA. Interaction of grapefruit juice and calcium channel blockers. American Journal of Hypertension 2006;19:768-73.
78. Singh BN. The mechanism of action of calcium antagonists relative to their clinical applications. British Journal of Clinical Pharmacology 1986;21 Suppl 2:109-21.
79. Tsushima RG, Wickenden AD, Bouchard RA, Oudit GY, Liu PP, Backx PH. Modulation of iron uptake in heart by L-type Ca2+ channel modifiers: possible implications in iron overload. Circulation Research 1999;84(11):1302-9.
80. Voskaridou E1, Ladis V, Kattamis A, et al. A national registry of haemoglobinopathies in Greece: deducted demographics, trends in mortality and affected births. Annals of Hematology Sept 2012;91(9):1451-8.
81. Wang ZJ, Fischer R, Chu Z, Mahoney DH Jr, Mueller BU, Muthupillai R. Assessment of cardiac iron by MRI susceptometry and R2* in patients with thalassemia. Magnetic Resonance Imaging 2010;28(3):363-71.
82. Weatherall DJ, Clegg JB. Inherited haemoglobin disorders: an increasing global health problem. Bulletin of the World Health Organization 2001;79:704-12.
83. Wenzel RR, Allegranza G, Binggeli C, Shaw S, Weidmann P, Luscher TF, et al. Differential activation of cardiac and peripheral sympathetic nervous system by nifedipine: role of pharmacokinetics. Journal of the American College of Cardiology 1997;29(7):1607-14.
84. Williamson PR, Smith CT, Hutton JL, Marson AG. Aggregate data meta-analysis with time-to-event outcomes. Statistics in Medicine 2002;21(22):3337-51.
85. Wood JC, Tyszka JM, Carson S, Nelson MD, Coates TD. Myocardial iron loading in transfusion-dependent thalassemia and sickle cell disease. Blood 2004;103(5):1934-6.
86. Wood JC, Enriquez C, Ghugre N, Otto-Duessel M, Aguilar M, Nelson MD, et al. Physiology and pathophysiology of iron cardiomyopathy in thalassaemia. Annals of the New York Academy of Sciences 2005;1054:386-95.
87. Wood JC, Origa R, Agus A, Matta G, Coates TD, Galanello R. Onset of cardiac iron loading in pediatric patients with thalassemia major. Haematologica 2008;93(6):917-20.
88. Xia S, Zhang W, Huang L, Jiang H. Comparative efficacy and safety of deferoxamine, deferiprone and deferasirox on severe thalassemia: a meta-analysis of 16 randomised controlled trials. PLoS One 2013;8(12):e82662.
89. Zhelyazkova-Savova M, Gancheva S, Sirakova S. Potential statin-drug interactions: prevalence and clinical significance. Springerplus 2014;3:168.