Efficacy of fixed-dose combination therapy in the treatment of patients with hypertension: Focus on amlodipinevalsartan

Clinical Drug Investigation

Volumn 30, Issue 9, 2010, Pages 625-641

  Da Silva, Pedro Marques ^a  

^a CHLC   (Portugal)

Author keywords

Amlodipine; Amlodipinevalsartan; Angiotensin type 1 receptor antagonists; Calcium channel antagonists; Hypertension; therapeutic use; treatment; Valsartan

Indexed keywords

AMLODIPINE; AMLODIPINE PLUS VALSARTAN; CALCIUM CHANNEL BLOCKING AGENT; VALSARTAN; AMLODIPINE, VALSARTAN DRUG COMBINATION; ANGIOTENSIN 1 RECEPTOR ANTAGONIST; ANTIHYPERTENSIVE AGENT; DRUG COMBINATION; TETRAZOLE DERIVATIVE;

ANKLE EDEMA; ANTIHYPERTENSIVE THERAPY; BACKACHE; BLOOD PRESSURE REGULATION; CLINICAL TRIAL; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; ESSENTIAL HYPERTENSION; FATALITY; HEADACHE; HEART INFARCTION; HIGH RISK PATIENT; HOT FLUSH; HUMAN; HYPERTENSION; METABOLIC DISORDER; MONOTHERAPY; MORBIDITY; MORTALITY; MUSCLE SPASM; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PRIORITY JOURNAL; RESPIRATORY TRACT INFECTION; REVIEW; RHINOPHARYNGITIS; RISK BENEFIT ANALYSIS; STROKE; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; URINARY TRACT INFECTION; BLOOD PRESSURE; DRUG COMBINATION; DRUG EFFECTS; PATHOPHYSIOLOGY;

AMLODIPINE; ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; CALCIUM CHANNEL BLOCKERS; DRUG COMBINATIONS; HUMANS; HYPERTENSION; TETRAZOLES; TREATMENT OUTCOME;

EID: 77954633900     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11538440-000000000-00000     Document Type: Review

References (80)

1. 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; 289 (19): 2560-2572
2. 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). Eur Heart J 2007; 28 (12): 1462-1536
3. Neal B, MacMahon S, Chapman N. Effects of ACE inhibitors, calciumantagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Blood Pressure Lowering Treatment Trialists' Collaboration. Lancet 2000; 356 (9246): 1955-1964
4. Turnbull F, Neal B, Algert C, et al. Effects of different blood pressure-lowering regimens onmajor cardiovascular events in individuals with and without diabetes mellitus: results of prospectively designed overviews of randomized trials. Arch Intern Med 2005; 165(12): 1410-1419
5. Staessen JA, Wang JG, Thijs L. Cardiovascular prevention and blood pressure reduction: a quantitative overview updated until 1March 2003. J Hypertens 2003; 21(6): 1055-1076
6. 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
7. Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359 (9311): 995-1003 (Pubitemid 34286536)
8. Progress Collaborative Group. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6,105 individuals with previous stroke or transient ischaemic attack. Lancet 2001; 358 (9287): 1033-1041
9. Turnbull F. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. Lancet 2003; 362 (9395): 1527-1535
10. Whitworth JA. 2003 World Health Organization (WHO)/ International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens 2003; 21 (11): 1983-1992
11. National Collaborating Centre for Chronic Conditions. Hypertension: management of hypertension in adults in primary care. Partial update. London: Royal College of Physicians, 2006
12. 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
13. Stankus V, Hemmelgarn B, Campbell NR, et al. Reducing costs and improving hypertension management. Can J Clin Pharmacol 2009; 16 (1): e151-5
14. Bangalore S, Kamalakkannan G, Parkar S, et al. Fixed-dose combinations improve medication compliance: a metaanalysis. Am J Med 2007; 120 (8): 713-719
15. Waeber B, Detry JM,Dahlof B, et al. Felodipine-metoprolol combination tablet: a valuable option to initiate antihypertensive therapy? Am J Hypertens 1999; 12 (9 Pt 1): 915-920
16. Waeber B, Ruilope LM. Amlodipine and valsartan as components of a rational and effective fixed-dose combination. Vasc Health Risk Manag 2009; 5 (1): 165-174
17. Wald DS, Law M, Morris JK, et al. Combination therapy versus monotherapy in reducing blood pressure: metaanalysis on 11,000 participants from 42 trials. Am J Med 2009; 122 (3): 290-300
18. Frampton JE, Scott LJ. Amlodipine/valsartan single-pill combination: a review of its use in the management of hypertension. Am J Cardiovasc Drugs 2009; 9 (5): 309-330
19. Jamerson KA, Nwose O, Jean-Louis L, et al. Initial angiotensin-converting enzyme inhibitor/calcium channel blocker combination therapy achieves superior blood pressure control compared with calcium channel blocker monotherapy in patients with stage 2 hypertension. Am J Hypertens 2004; 17 (6): 495-501
20. Messerli FH, Oparil S, Feng Z. Comparison of efficacy and side effects of combination therapy of angiotensin-converting enzyme inhibitor (benazepril) with calcium antagonist (either nifedipine or amlodipine) versus high-dose calcium antagonist monotherapy for systemic hypertension. Am J Cardiol 2000; 86 (11): 1182-1187
21. Philipp T, Smith TR, Glazer R, et al. Two multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel-group studies evaluating the efficacy and tolerability of amlodipine and valsartan in combination and as monotherapy in adult patients with mild to moderate essential hypertension. Clin Ther 2007; 29 (4): 563-580
22. Waeber B, Feihl F, Ruilope LM. Fixed-dose combinations as initial therapy for hypertension: a review of approved agents and a guide to patient selection. Drugs 2009; 69 (13): 1761-1776
23. Nathan S, Pepine CJ, Bakris GL. Calcium antagonists: effects on cardio-renal risk in hypertensive patients. Hypertension 2005; 46 (4): 637-642
24. Ram CV. Antihypertensive drugs: an overview. Am J Cardiovasc Drugs 2002; 2 (2): 77-89
25. Brewster UC, Setaro JF, Perazella MA. The renin-angiotensin-aldosterone system: cardiorenal effects and implications for renal and cardiovascular disease states. Am J Med Sci 2003; 326 (1): 15-24
26. Schmieder RE, Hilgers KF, Schlaich MP, et al. Reninangiotensin system and cardiovascular risk. Lancet 2007; 369 (9568): 1208-1219
27. Chrysant SG. Using fixed-dose combination therapies to achieve blood pressure goals. Clin Drug Investig 2008; 28 (11): 713-734
28. Ferrari R. Angiotensin-converting enzyme inhibition in cardiovascular disease: evidence with perindopril. Expert Rev Cardiovasc Ther 2005; 3 (1): 15-29
29. Gradman AH, Cutler NR, Davis PJ, et al. Combined enalapril and felodipine extended release (ER) for systemic hypertension. Enalapril-Felodipine ER Factorial Study Group. Am J Cardiol 1997; 79 (4): 431-435
30. Poisson P, Bauer B, Schueler E, et al. Ramipril and felodipine: a comparison of the efficacy and safety of monotherapy versus combination therapy. Curr Med Res Opinion 1996; 13 (8): 445-456
31. Pool J, Kaihlanen P, Lewis G, et al. Once-daily treatment of patients with hypertension: a placebo-controlled study of amlodipine and benazepril vs amlodipine or benazepril alone. J Hum Hypertens 2001; 15 (7): 495-498
32. Roca-Cusachs A, Torres F, Horas M, et al. Nitrendipine and enalapril combination therapy in mild to moderate hypertension: assessment of dose-response relationship by a clinical trial of factorial design. J Cardiovasc Pharmacol 2001; 38 (6): 840-849
33. Scholze J, Zilles P, Compagnone D. Verapamil SR and trandolapril combination therapy in hypertension: a clinical trial of factorial design. German Hypertension Study Group. Br J Clin Pharmacol 1998; 45 (5): 491-495
34. Ueng KC, Lin LC, Voon WC, et al. An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in Chinese patients with mild to moderate hypertension. Blood Press 2008; Suppl. 1: 24-31
35. Burnier M, Brunner HR. Angiotensin II receptor antagonists. Lancet 2000; 355 (9204): 637-645
36. Schmieder RE. Mechanisms for the clinical benefits of angiotensin II receptor blockers. Am J Hypertens 2005; 18 (5 Pt 1): 720-730
37. Black HR, Bailey J, Zappe D, et al. Valsartan: more than a decade of experience. Drugs 2009; 69 (17): 2393-2414
38. Ibrahim MM. RAS inhibition in hypertension. J Hum Hypertens 2006; 20 (2): 101-108
39. Epstein BJ, Vogel K, Palmer BF. Dihydropyridine calcium channel antagonists in the management of hypertension. Drugs 2007; 67 (9): 1309-1327
40. Lindholm LH, Ibsen H, Dahlof B, et al. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359 (9311): 1004-1010 (Pubitemid 34286537)
41. Oparil S, Weber M. Angiotensin receptor blocker and dihydropyridine calcium channel blocker combinations: an emerging strategy in hypertension therapy. Postgrad Med 2009; 121 (2): 25-39
42. Stump CS, Hamilton MT, Sowers JR. Effect of antihypertensive agents on the development of type 2 diabetes mellitus. Mayo Clin Proc 2006; 81 (6): 796-806
43. Ostergren J. Renin-angiotensin-system blockade in the prevention of diabetes. Diabetes Res Clin Pract 2007; 76 Suppl. 1: S13-21
44. Abuissa H, Jones PG, Marso SP, et al. Angiotensinconverting enzyme inhibitors or angiotensin receptor blockers for prevention of type 2 diabetes: a meta-analysis of randomized clinical trials. J Am Coll Cardiol 2005; 46 (5): 821-826
45. Waeber B. Combination therapy with ACE inhibitors/ angiotensin II receptor antagonists and diuretics in hypertension. Expert Rev Cardiovasc Ther 2003; 1 (1): 43-50
46. Lithell H, Hansson L, Skoog I, et al. The Study on Cognition and Prognosis in the Elderly (SCOPE): principal results of a randomized double-blind intervention trial. J Hypertens 2003; 21 (5): 875-886 (Pubitemid 36677151)
47. Patel A, MacMahon S, Chalmers J, et al. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet 2007; 370 (9590): 829-840
48. Jamerson K, Weber MA, Bakris GL, et al. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med 2008; 359 (23): 2417-2428
49. Jamerson K, Bakris GL, Dahlof B, et al. Exceptional early blood pressure control rates: the ACCOMPLISH trial. Blood Press 2007; 16 (2): 80-86
50. Yusuf S, Teo KK, Pogue J, et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med 2008; 358 (15): 1547-1559
51. Reboldi G, Angeli F, Cavallini C, et al. Comparison between angiotensin-converting enzyme inhibitors and angiotensin receptor blockers on the risk of myocardial infarction, stroke and death: ameta-analysis. JHypertens 2008; 26 (7): 1282-1289
52. Volpe M, Tocci G, Sciarretta S, et al. Angiotensin II receptor blockers and myocardial infarction: an updated analysis of randomized clinical trials. J Hypertens 2009; 27 (5): 941-946
53. Dahlof B, Sever PS, Poulter NR, et al. Prevention of cardiovascular 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 (9489): 895-906
54. Gupta AK, Dahlof B, Dobson J, et al. Determinants of newonset diabetes among 19,257 hypertensive patients randomized in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm and the relative influence of antihypertensive medication. Diabetes Care 2008; 31 (5): 982-988
55. Pepine CJ, Handberg EM, Cooper-DeHoff RM, et al. A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-Trandolapril Study (INVEST): a randomized controlled trial. JAMA 2003; 290 (21): 2805-2816
56. Solomon SD, Verma A, Desai A, et al. Effect of intensive versus standard blood pressure lowering on diastolic function in patients with uncontrolled hypertension and diastolic dysfunction. Hypertension 2010; 55 (2): 241-248
57. Haria M, Wagstaff AJ. Amlodipine: a reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease. Drugs 1995; 50 (3): 560-586
58. Cohn JN, Tognoni G. A randomized trial of the angiotensinreceptor blocker valsartan in chronic heart failure. N Engl J Med 2001; 345 (23): 1667-1675
59. Latini R, Masson S, Anand I, et al. Effects of valsartan on circulating brain natriuretic peptide and norepinephrine in symptomatic chronic heart failure: the Valsartan Heart Failure Trial (Val-HeFT). Circulation 2002; 106 (19): 2454-2458
60. Maggioni AP, Anand I, Gottlieb SO, et al. Effects of valsartan on morbidity and mortality in patients with heart failure not receiving angiotensin-converting enzyme inhibitors. J Am Coll Cardiol 2002; 40 (8): 1414-1421
61. Maggioni AP, Latini R, Carson PE, et al. Valsartan reduces the incidence of atrial fibrillation in patients with heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT). Am Heart J 2005; 149 (3): 548-557
62. Wong M, Staszewsky L, Latini R, et al. Valsartan benefits left ventricular structure and function in heart failure: Val-HeFT echocardiographic study. J Am Coll Cardiol 2002; 40 (5): 970-975
63. Pfeffer MA, McMurray JJ, Velazquez EJ, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003; 349 (20): 1893-1906
64. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363 (9426): 2022-2031
65. Julius S, Weber MA, Kjeldsen SE, et al. The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) trial: outcomes in patients receiving monotherapy. Hypertension 2006; 48 (3): 385-391
66. Weber MA, Julius S, Kjeldsen SE, et al. Blood pressure dependent and independent effects of antihypertensive treatment on clinical events in the VALUE trial. Lancet 2004; 363 (9426): 2049-2051
67. Kjeldsen SE, Julius S, Mancia G, et al. Effects of valsartan compared to amlodipine on preventing type 2 diabetes in high-risk hypertensive patients: the VALUE trial. J Hypertens 2006; 24 (7): 1405-1412
68. Mochizuki S, Dahlof B, Shimizu M, et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, openlabel, blinded endpoint morbidity-mortality study. Lancet 2007; 369 (9571): 1431-1439
69. Sawada T, Yamada H, Dahlof B, et al. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART study. Eur Heart J 2009; 30 (20): 2461-2469
70. Kohlmann Jr O, Oigman W, Mion D, et al. The "LOTHAR" study: evaluation of efficacy and tolerability of the fixed combination of amlodipine and losartan in the treatment of essential hypertension. Arq Bras Cardiol 2006; 86 (1): 39-51
71. Sharma A, Bagchi A, Kinagi SB, et al. Results of a comparative, phase III, 12-week, multicenter, prospective, randomized, double-blind assessment of the efficacy and tolerability of a fixed-dose combination of telmisartan and amlodipine versus amlodipine monotherapy in Indian adults with stage II hypertension. Clin Ther 2007; 29 (12): 2667-2676
72. Smith TR, Philipp T, Vaisse B, et al. Amlodipine and valsartan combined and as monotherapy in stage 2, elderly, and black hypertensive patients: subgroup analyses of 2 randomized, placebo-controlled studies. J Clin Hypertens (Greenwich) 2007; 9 (5): 355-364
73. Plosker G, Robinson D. Amlodipine/valsartan fixed-dose combination in hypertension. Drugs 2008; 68 (3): 378-381
74. Fogari R, Zoppi A, Derosa G, et al. Effect of valsartan addition to amlodipine on ankle oedema and subcutaneous tissue pressure in hypertensive patients. J Hum Hypertens 2007; 21 (3): 220-224
75. Trenkwalder P, Schaetzl R, Borbas E, et al. Combination of amlodipine 10mg and valsartan 160mg lowers blood pressure in patients with hypertension not controlled by an ACE inhibitor/ CCB combination. Blood Press 2008; Suppl. 2: 13-21
76. Sinkiewicz W, Glazer RD, Kavoliuniene A, et al. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy. Curr Med Res Opin 2009; 25 (2): 315-324
77. Brachmann J, Ansari A, Mahla G, et al. Effective and safe reduction of blood pressure with the combination of amlodipine 5mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy. Adv Ther 2008; 25 (5): 399-411
78. Poldermans D, Glazes R, Kargiannis S, et al. Tolerability and blood pressure-lowering efficacy of the combination of amlodipine plus valsartan compared with lisinopril plus hydrochlorothiazide in adult patients with stage 2 hypertension. Clin Ther 2007; 29 (2): 279-289
79. Allemann Y, Fraile B, Lambert M, et al. Efficacy of the combination of amlodipine and valsartan in patients with hypertension uncontrolled with previous monotherapy: the Exforge in Failure after Single Therapy (EX-FAST) study. J Clin Hypertens (Greenwich) 2008; 10 (3): 185-194
80. Fogari R, Zoppi A, Mugellini A, et al. Efficacy and safety of two treatment combinations of hypertension in very elderly patients. Arch Gerontol Geriatr 2009; 48 (3): 401-405