Disclosures This study was supported and funded by Novartis Pharma AG, Basel, Switzerland. Timothy Smith and Michael J. Koren have no conflict of interest to declare. Robert D. Glazer, Margaret Wernsing and Ying Zhang are employees of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Combination therapy with amlodipine/valsartan in essential hypertension: a 52-week, randomised, open-label, extension study
Article first published online: 16 AUG 2010
© 2010 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 64, Issue 10, pages 1367–1374, September 2010
How to Cite
Smith, T. R., Glazer, R. D., Koren, M. J., Wernsing, M. and Zhang, Y. (2010), Combination therapy with amlodipine/valsartan in essential hypertension: a 52-week, randomised, open-label, extension study. International Journal of Clinical Practice, 64: 1367–1374. doi: 10.1111/j.1742-1241.2010.02480.x
- Issue published online: 16 AUG 2010
- Article first published online: 16 AUG 2010
- Paper received May 2010, accepted May 2010
Background: A majority of hypertensive patients require ≥ 2 agents to achieve target blood pressure (BP).
Methods: This 52-week, multicentre, open-label, randomised extension trial to a previously reported double-blind, placebo-controlled study evaluated the safety and efficacy of amlodipine/valsartan (Aml/Val) combination. Patients who successfully completed the core study without serious drug-related adverse events (AEs) and mean sitting systolic BP (MSSBP)/mean sitting diastolic BP (MSDBP) ≤ 150/95 mmHg were eligible to enter the extension and be treated with Aml/Val 2.5/80 or 5/80 mg. After 4 weeks of treatment, patients underwent force-titration to receive 5/160 mg (low dose) or 10/160 mg (high dose) for 48 weeks. Addition of hydrochlorothiazide (HCTZ) 12.5 mg was permitted if BP was ≥ 140/90 mmHg at Week 8 or later. Patients could be down-titrated to the prior lower combination dose with or without HCTZ if an intolerable AE occurred. Safety evaluations included monitoring of AEs. Efficacy variables were change from baseline in MSDBP (primary) and MSSBP (secondary).
Results: Of 1246 patients randomised, 1075 (86.3%) completed the extension study. At week 52 end-point, change in MSSBP/MSDBP from core study baseline was −22.1/−17.2 mmHg for low-dose regimen and −22.8/−18.1 mmHg for high-dose regimen. For both regimens, reductions in BP were sustained over 52 weeks and mean BP maintained below approximately 135/85 mmHg at all visits. Frequent AEs in the low- and high-dose regimens were peripheral oedema (9.7% and 17.1% respectively), nasopharyngitis (8.1% and 7.2%), and dizziness (5.2% and 7.0%). Incidence of serious AEs was 3.7% with low dose and 4.1% with high dose.
Conclusion: The combination of Aml/Val with the optional addition of HCTZ produced clinically significant and persistent reductions in BP over 52 weeks with a favourable tolerability profile.