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▴ Amlodipine, a dihydropyridine calcium channel blocker, and valsartan, an angiotensin II receptor blocker, are established antihypertensive agents. Fixed-dose combinations of amlodipine/valsartan are available in several European countries and in the US. Individual dose titration with amlodipine and valsartan is generally recommended before changing to the fixed-dose combination.
▴ Amlodipine/valsartan, at approved dosage regimens, achieved significantly greater reductions in mean sitting diastolic and systolic blood pressure (BP) than amlodipine or valsartan monotherapy, or placebo in two randomized, double-blind, factorial trials in patients with mild to moderate hypertension.
▴ Approximately 80–90% of patients receiving approved dosages of amlodipine/valsartan achieved a response, defined as a mean sitting diastolic BP <90 mmHg or a ≥10 mmHg reduction from baseline.
▴ Subgroup analyses of data from the two trials showed that the antihypertensive efficacy of amlodipine/valsartan in the elderly, Black patients and those with stage 2 hypertension was consistent with that observed in the overall study population.
▴ Marked reductions in BP were also observed in patients whose BP was previously uncontrolled on monotherapy (with various antihypertensives) who were switched (without washout) to amlodipine/valsartan in a phase IIIb-IV study.
▴ Amlodipine/valsartan was generally well tolerated in clinical trials. In particular, the incidence of peripheral oedema was significantly lower in patients receiving amlodipine/valsartan than in those treated with amlodipine monotherapy.
KeywordsAmlodipine Valsartan HCTZ Peripheral Oedema Moderate Hypertension
Acknowledgements and Disclosures
The manuscript was reviewed by: J.P. Baguet, Department of Cardiology and Hypertension, Grenoble University Hospital, Grenoble, France; L. Frost, Department of Medicine and Clinical Institute, Silkeborg Hospital, Aarhus University Hospital, Silkeborg, Denmark; M.F. O’Rourke, St Vincent’s Clinic, Carlinghurst, New South Wales, Australia; D. Poldermans, Erasmus Medisch Centrum Rotterdam, Rotterdam, The Netherlands.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes resulting from any comments received were made on the basis of scientific and editorial merit.
- 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). J Hypertens 2007 Jun; 25(6): 1105–87PubMedCrossRefGoogle Scholar
- 3.Dahlöf 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 multientre randomised controlled trial. Lancet 2005 Sep 10; 366(9489): 895–906PubMedCrossRefGoogle Scholar
- 4.European Medicines Agency (EMEA). Summary of product characteristics: Exforge® (amlodipine/valsartan) film-coated tablets [online]. Available from URL: http://www.emea.europa.eu [Accessed 2007 Aug 13]
- 5.Novartis. Exforge® (amlodipine and valsartan) prescribing information. East Hanover (NJ): Novartis Pharmaceuticals Corp., 2007 Apr [online]. Available from URL: http://www.pharma.us.novartis.com [Accessed 2007 Sep 14]
- 15.Maeda T, Kato M, Tajima A, et al. Additive effect of valsartan on exercise tolerance in hypertensive patients treated with amlodipine [abstract no. PO4-154]. J Hypertens 2006 Dec 1; 24 Suppl. 6: 399Google Scholar
- 16.Fogari R, Preti P, Mugellini A, et al. Valsartan amlodipine combination and prevention of atrial fibrillation recurrence in hypertensive diabetic patients [abstract no. 3695]. Circulation 2006 Oct 31; 114 (18 Suppl. II): 789–90Google Scholar
- 18.Leenen FHH, Nwachuku CE, Black HR, et al. Clinical events in high-risk hypertensive patients randomly assigned to calcium channel blocker versus angiotensin-converting enzyme inhibitor in the antihypertensive and lipid-lowering treatment to prevent heart attack trial. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Collaborative Research Group. Hypertension 2006; 48: 374–84PubMedCrossRefGoogle Scholar
- 26.Pfeffer MA, McMurray JJV, Velazquez EJ, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. Valsartan in Acute Myocardial Infarction (VALIANT) Trial Investigators. N Engl J Med 2003 Nov 13; 349(20): 1893–906PubMedCrossRefGoogle Scholar
- 27.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 Apr; 29(4): 563–80PubMedCrossRefGoogle Scholar
- 29.Allemann Y, Fraile B, Lambert M, et al. Efficacy of the combination of amlodipine and valsartan in hypertensive patients uncontrolled on previous monotherapy: the EX-FAST study. J Clin Hypertens. Epub in advance Feb 2008Google Scholar
- 31.Poldermans D, Glazer R, Karagianniss 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 Feb; 29(2): 279–89PubMedCrossRefGoogle Scholar