Amlodipine atorvastatin: A Review of its use in the treatment of hypertension and dyslipidaemia and the prevention of cardiovascular disease

Drugs

Volumn 70, Issue 2, 2010, Pages 191-213

  Curran, Monique P ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Amlodipine; Amlodipineatorvastatin; Amlodipineatorvastatin, herapeuticuse; Atorvastatin; Hyperlipidaemia; Hypertension; Pharmacodynamics; Pharmacokinetics; Rmacodynamics

Indexed keywords

AMLODIPINE; AMLODIPINE PLUS ATORVASTATIN; ATENOLOL; ATORVASTATIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO;

ABDOMINAL PAIN; ARTHRALGIA; ASTHENIA; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; DIARRHEA; DIZZINESS; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG EXCRETION; DRUG INHIBITION; DRUG METABOLISM; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; EDEMA; HEADACHE; HUMAN; HYPERTENSION; MYALGIA; PATIENT COMPLIANCE; RESPIRATORY TRACT INFECTION; REVIEW; RHINOPHARYNGITIS; SYSTOLIC BLOOD PRESSURE; TABLET FORMULATION; URINARY TRACT INFECTION;

AMLODIPINE; ANTICHOLESTEREMIC AGENTS; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DRUG COMBINATIONS; DYSLIPIDEMIAS; HEPTANOIC ACIDS; HUMANS; HYPERTENSION; LIPOPROTEINS, LDL; PATIENT COMPLIANCE; PYRROLES; TREATMENT OUTCOME;

EID: 75749143964     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11204420-000000000-00000     Document Type: Review

References (92)

1. World Health Organization. Cardiovascular disease (fact sheet no. 317) [online]. Available from URL: http://www.who.int/mediacentre/factsheets/fs317/ en/print.html [Accessed 2009 Oct 12]
2. Lloyd-Jones D, Adams R, Carnethon M, et al. Heart disease and stroke statistics-2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2009 Jan 27; 119 (3): e21-181
3. Jackson R, Lawes CMM, Bennertt DA, et al. Treatment with drugs to lower blood pressure and blood cholesterol based on an individual's absolute cardiovascular risk. Lancet 2005; 365: 434-441
4. Johnson ML, Pietz K, Battleman DS, et al. Prevalence of comorbid hypertension and dyslipidemia and associated cardiovascular disease. Am J Manag Care 2004; 10: 926-932
5. Emberson J, Whincup P, Morris R, et al. Evaluating the impact of population and high-risk strategies for the primary prevention of cardiovascular disease. Eur Heart J 2004 Mar; 25 (6): 484-491
6. Graham I, Atar D, Borch-Johnsen K, et al. European guide-lines on cardiovascular disease prevention in clinical practice: executive summary. Atherosclerosis 2007 Sep; 194 (1): 1-45
7. Mancia G, Laurent S, Agabiti-Rosei E, et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens 2009; 27: 2121-2158
8. The Task Force for the Management of Arterial Hyperten-sion of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). 2007 guidelines for the management of arterial hypertension. Eur Heart J 2007; 28: 1462-1536
9. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001 May 16 285 (19) 2486-2497
10. De Backer G, Ambrosioni E, Borch-Johnsen K, et al. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of eight societies and by invited experts). Atherosclerosis 2004 Apr; 173 (2): 381-391
11. European Society of Hypertension-European Society of Car-diology. 2003 European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2003 Jun; 21 (6): 1011-1053
12. Mancia G, De Backer G, Dominiczak A, et al. 2007 guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007 Jun; 25 (6): 1105-1187 (Pubitemid 46924065)
13. Joint National Committee on Prevention, Detection, Eva-luation, and Treatment of High Blood Pressure. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med 1997; 157: 2413-2446
14. Chobanian AV, Bakris GL, Black HR, et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003 May 21; 289 (19): 2560-2572
15. Bangalore S, Kamalakkannan G, Parkar S, et al. Fixed-dose combinations improve medication compliance: a metaanalysis. Am J Med 2007; 120: 713-719
16. Dezii CM. A retrospective study of persistance with single-pill combination therapy vs concurrent two-pill therapy in patients with hypertension. Manag Care 2000; 9 Suppl.: 2-6
17. Haria M, Wagstaff AJ. Amlodipine: a reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease. Drugs 1995; 50 (3): 560-586
18. Pfizer Labs. Caduet® (amlodipine besylate/atorvastatin cal-cium) tablets: US prescribing information [online]. Available from URL: http://www.caduet.com [Accessed 2009 Sep 18]
19. MIMS Australia. Caduet: full prescribing information. Sydney (NSW): 2009 Apr 1
20. Sica DA. Pharmacotherapy review: calcium channel blockers. J Clin Hypertens (Greenwich) 2006 Jan; 8 (1): 53-56
21. Zhang X, Hintze TH. Amlodipine releases nitric oxide from canine coronary microvessels: an unexpected mechanism of action of a calcium channel-blocking agent. Circulation 1998 Feb 17; 97 (6): 576-580
22. Mason RP, Marche P, Hintze TH. Novel vascular biology of third-generation L-type calcium channel antagonists: ancillary actions of amlodipine. Arterioscler Thromb Vasc Biol 2003 Dec; 23 (12): 2155-2163
23. Trion A, de Maat M, Jukema W, et al. Anti-atherosclerotic effect of amlodipine, alone and in combination with ator-vastatin, in APOE*3-Leiden/ hCRP transgenic mice. J Cardiovasc Pharmacol 2006 Jan; 47 (1): 89-95
24. Malhotra HS, Goa KL. Atorvastatin: an updated review of its pharmacological properties and use in dyslipidaemia. Drugs 2001; 61 (12): 1835-1881
25. Poli A. Atorvastatin: pharmacological characteristics and lipid-lowering effects. Drugs 2007; 67 Suppl. 1: 3-15
26. Croom KF, Plosker GL. Atorvastatin: a review of its use in the primary prevention of cardiovascular events in patients with type 2 diabetes mellitus. Drugs 2005; 65 (1): 137-152
27. Rubba P. Effects of atorvastatin on the different phases of atherogenesis. Drugs 2007; 67 Suppl. 1: 17-27
28. Manisty C, Mayet J, Tapp RJ, et al. Atorvastatin treatment is associated with less augmentation of the carotid pressure waveform in hypertension: a substudy of the Anglo-Scandinavian Cardiac Outcome Trial (ASCOT). Hypertension 2009 Nov; 54 (5): 1009-1013
29. Siragy HM. Improving vascular function in hypertension: potential benefits of combination therapy with amlodipine and renin-angiotensin- aldosterone system blockers. J Hy-pertens 2010 Jan; 28 (1): 2-8
30. Mason RP. A rational for combined therapy with a calcium channel blocker and a statin: evaluation of basic and clinical evidence. Curr Drug Targets Cardiovasc Haematol Disord 2005; 5 (6): 489-501
31. Mason RP, Kubant R, Heeba G, et al. Synergistic effect of amlodipine and atorvastatin in reversing LDL-induced endothelial dysfunction. Pharm Res 2008 Aug; 25 (8): 1798-1806
32. Charbonneau F, Anderson TJ, Title L, et al. Modulation of arterial reactivity using amlodipine and atorvastatin measured by ultrasound examination (MARGAUX). Atherosclerosis 2008; 197 (1): 420-427
33. Ge C-J, Lu S-Z, Chen Y-D, et al. Synergistic effect of am-lodipine and atorvastatin on blood pressure, left ventricular remodeling, and C-reactive protein in hypertensive patients with primary hypercholesterolemia. Heart Vessels 2008; 23 (2): 91-95
34. Fogari R, Preti P, Zoppi A, et al. Effects of amlodipine-ator-vastatin combination on inflammation markers and insulin sensitivity in normocholesterolemic obese hypertensive patients. Eur J Clin Pharmacol 2006 Oct; 62: 817-822
35. Koh KK, Quon MJ, Han SH, et al. Additive beneficial effects of atorvastatin combined with amlodipine in patients with mild-to-moderate hypertension. Int J Cardiol. Epub 2009 Aug 1
36. Fogari R, Derosa G, Lazzari P, et al. Effect of amlodipine-atorvastatin combination on fibrinolysis in hypertensive hypercholesterolemic patients with insulin resistance. Am J Hypertens 2004 Sep; 17 (9): 823-827
37. Delsing DJ, Jukema JW, van de Wiel MA, et al. Differential effects of amlodipine and atorvastatin treatment and their combination on atherosclerosis in ApoE*3-Leiden trans-genic mice. J Cardiovasc Pharmacol 2003 Jul; 42 (1): 63-70
38. van de Poll SW, Delsing DJ, Wouter Jukema J, et al. Effects of amlodipine, atorvastatin and combination of both on advanced atherosclerotic plaque in APOE*3-Leiden transgenic mice. J Mol Cell Cardiol 2003 Jan; 35(1): 109-118
39. van de Poll SW, Delsing DJ, Jukema JW, et al. Raman spec-troscopic investigation of atorvastatin, amlodipine, and both on atherosclerotic plaque development in APOE*3 Leiden transgenic mice. Atherosclerosis 2002 Sep; 164 (1): 65-71
40. Martin-Ventura JL, Munoz-Garcia B, Blanco-Colio LM, et al. Treatment with amlodipine and atorvastatin has additive effect on blood and plaque inflammation in hypertensive patients with carotid atherosclerosis. Kidney Int Suppl 2008 Dec; (111): S71-4
41. Cohn JN, Wilson DJ, Neutel J, et al. Coadministered am-lodipine and atorvastatin produces early improvements in arterial wall compliance in hypertensive patients with dys-lipidemia. Am J Hypertens 2009 Feb; 22 (2): 137-144
42. Leibovitz E, Beniashvili M, Zimlichman R, et al. Treatment with amlodipine and atorvastatin have additive effect in improvement of arterial compliance in hypertensive hyperlipi-demic patients. Am J Hypertens 2003 Sep; 16 (9 Pt 1): 715-718
43. McKeage K, Siddiqui MA. Amlodipine/atorvastatin fixed-dose combination: a review of its use in the prevention of cardiovascular disease and in the treatment of hypertension and dyslipidemia. Am J Cardiovasc Drugs 2008; 8 (1): 51-67
44. Pfizer Canada Inc. Caduet® (amlodipine besylate and ator-vastatin calcium tablets) product monograph [online]. Available from URL: http://www.pfizer.ca [Accessed 2009 Jan 1]
45. Chung M, Calcagni A, Glue P, et al. Bioavailability of am-lodipine besylate/atorvastatin calcium combination tablet. J Clin Pharmacol 2006 Sep; 46 (9): 1030-1037
46. Chung M, Calcagni A, Glue P, et al. Effect of food on the bioavailability of amlodipine besylate/atorvastatin calcium combination tablet. J Clin Pharmacol 2006 Oct; 46 (10): 1212-1216 (Pubitemid 44387422)
47. Boyd RA, Stern RH, Stewart BH, et al. Atorvastatin coad-ministration may increase digoxin concentrations by inhibition of intestinal P-glycoprotein- mediated secretion. J Clin Pharmacol 2000; 40: 91-98
48. Arca M. Atorvastatin efficacy in the prevention of cardio-vascular events in patients with diabetes mellitus and/or metabolic syndrome. Drugs 2007; 67 Suppl. 1: 43-54
49. Messerli FH, Bakris GL, Ferrera D, et al. Efficacy and safety of coadministered amlodipine and atorvastatin in patients with hypertension and dyslipidemia: results of the AVALON trial. J Clin Hypertens 2006 Aug; 8 (8): 571-581
50. Preston RA, Harvey P, Herfert O, et al. A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia: the Respond trial. J Clin Pharmacol 2007; 47: 1555-1569
51. Blank R, Lasalle J, Reeves R, et al. Single-pill therapy in the treatment of concomitant hypertension and dyslipidemia (the amlodipine/atorvastatin Gemini study). J Clin Hypertens 2005 May; 7 (5): 264-273
52. Erdine S, Ro YM, Tse HF, et al. Single-pill amlodipine/atorvastatin helps patients of diverse ethnicity attain recommended goals for blood pressure and lipids (the Gemini-AALA study). J Hum Hypertens 2009 Mar; 23 (3): 196-210
53. Flack JM, Victor R, Watson K, et al. Improved attain-ment of blood pressure and cholesterol goals using single-pill amlodipine/atorvastatin in African Americans: the CAPABLE trial. Mayo Clin Proc 2008 Jan; 83 (1): 35-45
54. Neutel JM, Bestermann WH, Dyess EM, et al. The use of a single-pill calcium channel blocker/statin combination in the management of hypertension and dyslipidemia: a randomized, placebo-controlled, multicenter study. J Clin Hypertens 2009 Jan; 11 (1): 22-30
55. Pfizer Inc. A multi-center, randomized study to evaluate efficacy and safety of a fixed combination therapy of amlo-dipine and atorvastatin in the treatment of concurrent hypertension and hyper-LDL-cholesterolemia [online]. Available from URL: http://www.clinicalstudyresults.org/docu ments/company-study-8859-0.pdf [Accessed 2009 Nov 25]
56. Hobbs FDR, Gensini G, Mancini GBJ, et al. International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines: the JEWEL programme. Eur J Cardiovasc Prev Re-habil 2009; 16 (4): 472-480
57. Patel BV, Leslie RS, Thiebaud P, et al. Adherence with sin-gle-pill amlodipine/atorvastatin vs a two-pill regimen. Vasc Health Risk Manag 2008; 4 (3): 673-681
58. Wong ND, Lopez V, Tang S, et al. Prevalence, treatment, and control of combined hypertension and hypercholesterolemia in the United States. Am J Cardiol 2006 Jul 15; 98 (2): 204-208
59. Ferdinand KC, Flack JM, Saunders E, et al. Amlodipine/atorvastatin single-pill therapy for blood pressure and lipid goals in African Americans: influence of the metabolic syndrome and type 2 diabetes mellitus. J Clin Hypertens (Greenwich) 2009 Oct; 11 (10): 585-593
60. Sever PS, Dahlof B, Poulter NR, et al. Prevention of cor-onary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003 Apr 5; 361 (9364): 1149-1158 (Pubitemid 36398384)
61. Sever PS, Poulter NR, Dahlof B, et al. Antihypertensive therapy and the benefits of atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial: lipid-lowering arm extension. J Hypertens 2009 May; 27 (5): 947-954
62. Sever P, Dahlof B, Poulter N, et al. Potential synergy be-tween lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial. Eur Heart J 2006; 27: 2982-2988
63. Lindgren P, Buxton M, Kahan T, et al. The lifetime cost-effectiveness of amlodipine-based therapy plus atorvastatin compared with atenolol plus atorvastatin, amlodipine-based therapy alone and atenolol-based therapy alone: results from ASCOT. Pharmacoeconomics 2009; 27 (3): 221-230
64. Gaede P, Vedel P, Larsen N, et al. Multifactorial interven-tion and cardiovascular disease in patients with type 2 diabetes. N Engl J Med 2003 Jan 30; 348 (5): 383-393 (Pubitemid 36159355)
65. Johnson ML, Pietz K, Battleman DS, et al. Therapeutic goal attainment in patients with hypertension and dyslipidemia. Med Care 2006 Jan; 44 (1): 39-46
66. MacDonald TM, Morant SV. Prevalence and treatment of isolated and concurrent hypertension and hypercholester-olaemia in the United Kingdom. Br J Clin Pharmacol 2008 May; 65 (5): 775-786
67. Chapman RH, Benner JS, Petrilla AA, et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med 2005; 165: 1147-1152
68. Kulkarni SP, Alexander KP, Lytle B, et al. Long-term ad-herence with cardiovascular drug regimens. Am Heart J 2006 Jan; 151 (1): 185-191
69. Wolf-Maier K, Cooper RS, Kramer H, et al. Hypertension treatment and control in five European countries, Canada, and the United States. Hypertension 2004 Jan; 43 (1): 10-17
70. Brenner JS, Chapman RH, Petrilla AA, et al. Association be-tween prescription burden and medication adherence in patients initiating antihypertensive and lipid-lowering therapy. Am J Health Syst Pharm 2009 Aug 15; 66 (16): 1471-1477
71. Chapman RH, Petrilla AA, Benner JS, et al. Predictors of adherence to concomitant antihypertensive and lipid-low-ering medications in older adults: a retrospective, cohort study. Drugs Aging 2008; 25 (10): 885-892
72. Thiebaud P, Demand M, Wolf SA, et al. Impact of disease management on utilization and adherence with drugs and tests: the case of diabetes treatment in the Florida: a Healthy State (FAHS) program. Diabetes Care 2008 Sep; 31 (9): 1717-1722
73. Soumerai SB, Pierre-Jacques M, Zhang F, et al. Cost-related medication nonadherence among elderly and disabled medicare beneficiaries: a national survey 1 year before the medicare drug benefit. Arch Intern Med 2006 Sep 25; 166 (17): 1829-1835
74. Dickson M, Plauschinat CA. Compliance with antihypertensive therapy in the elderly: a comparison of fixed-dose combination amlodipine/benazepril versus component-based free-combination therapy. Am J Cardiovasc Drugs 2008; 8 (1): 45-50
75. Agarwal S, Tang SS, Rosenberg N, et al. Does synchroniz-ing initiation of therapy affect adherence to concomitant use of antihypertensive and lipid-lowering therapy? Am J Ther 2009 Mar-2009 30; 16 (2): 119-126
76. National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand. Position statement on lipid management 2005 [online]. Available from URL: http://www.heartfoundation.org.au [Accessed 2009 Oct 28]
77. Australian Heart Foundation. Guide to management of hypertension 2008 [online]. Available from URL: http://www.heartfoundation.org.au/Professional- Information/Clinical-Practice/Hypertension [Accessed 2009 Oct 28]
78. Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005 Oct 8; 366 (9493): 1267-1278
79. Mason RP. Scientific rationale for combination of a calcium channel antagonist and an HMG-CoA reductase inhibitor: a new approach to risk factor management. Drugs 2008; 68 (7): 885-900
80. Henry PD, Bentley KI. Suppression of atherogenesis in cholesterol-fed rabbit treated with nifedipine. J Clin Invest 1981 Nov; 68 (5): 1366-1369
81. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hy-pertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363: 2022-2031
82. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). JAMA 2002; 288 (23): 2981-2997
83. Dahlof B, Sever PS, Poulter NR, et al. Prevention of cardio-vascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 2005; 366: 895-906
84. Nissen SE, Tuzcu EM, Libby P, et al. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure. The CAMELOT study: a randomized controlled trial. JAMA 2004; 292 (18): 2217-2226
85. Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004; 350 (15): 1495-1504
86. Pedersen TR, Faergeman O, Kastelein JJ, et al. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction. The IDEAL study: a randomized controlled trial. JAMA 2005 Nov 16; 294 (19): 2437-2445
87. Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Colloborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004; 364: 685-696
88. LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005 Apr 7; 352 (14): 1425-1435
89. Aslam F, Haque A, Lee V, et al. Patient adherence and preference considerations in managing cardiovascular risk: focus on single pill and amlodipine/atorvastatin fixed combination. Patient Prefer Adherence 2009; 3: 61-66
90. National Insititutes of Health. Caduet vs usual care in subjects with hypertension and additional risk factors (CRUCIAL) [online]. Available from URL: http://clinicaltrials.gov [Accessed 2009 Nov 6]
91. National Institutes of Health. Cardiovascular risk assessment in patients treated with caduet (RIGHT) [online]. Available from URL: http:// clinicaltrials.gov [Accessed 2009 Nov 6]
92. de la Sierra A. Mitigation of calcium channel blocker-related oedema in hypertension by antagonists of the renin-angio-tensin system. J Hum Hypertens 2009 Aug; 23 (8): 503-511