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Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study

Journal of Human Hypertension volume 23, pages 479–489 (2009)Cite this article

Abstract

The strategy of initiating hypertension treatment with combination versus single-drug therapy was formally tested in a prospective, double-blind, parallel-group trial in blacks with stage 2 hypertension (mean sitting systolic BP (MSSBP) ⩾160 and <200 mm Hg). Participants were randomized equally to amlodipine/valsartan (A/V) (n=286) or amlodipine (A) monotherapy (n=286). After 2 weeks, there was forced titration of A/V 5/160 mg to A/V 10/160 mg and of A 5 to A 10 mg followed by 10 additional weeks of treatment. If SBP was ⩾130 mm Hg at week 4, the protocol allowed optional titration of A/V to the 10/320 mg dose and, at week 8, hydrochlorothiazide 12.5 mg was optionally added to both A/V and A if SBP ⩾130 mm Hg. Amlodipine/valsartan at week 8 lowered MSSBP last observation carried forward significantly>A (33.3 vs 26.6 mm Hg, P<0.0001). Lowering of MSSBP with A/V significantly exceeded that of A in several specified subgroups—the elderly (⩾65 years), isolated systolic hypertension, and those with body mass index (BMI) ⩾30 kg/m2. More patients treated with A/V than A achieved BP control (<140/90 mm Hg) both at weeks 8 (49.8 vs 30.2%; P<0.0001) and 12 (57.2 vs 35.9%; P<0.0001). Both treatment regimens were well tolerated. In conclusion, the strategy of initiating combination antihypertensive drug therapy in blacks with stage 2 hypertension with amlodipine /valsartan achieves greater and quicker reductions in BP as well as significantly higher BP control rates than starting treatment with amlodipine monotherapy.

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Acknowledgements

This study was supported by Novartis Pharma AG. We acknowledge the support of all participating investigators. The sponsor was responsible for the design and conduct of the study and the collection of its data and its management. We were responsible for the preparation, review and final approval of the article. We thank Novartis employees, Teresa Gerlock, PhD and Kanaka Sridharan, MS. R.Ph, for editorial support. We also thank Samar A Nasser, PA-C, MPH for her assistance in preparing this article.

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Authors and Affiliations

  1. Wayne State University School of Medicine, Detroit, MI, USA

    J M Flack

  2. Department of Internal Medicine, Vascular Biology and Hypertension Program, University of Alabama at Birmingham, Birmingham, AL, USA

    D A Calhoun

  3. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    L Satlin & R Hilkert

  4. Novartis Pharma AG, Basel, Switzerland

    M Barbier & P Brunel

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  1. J M Flack
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  4. M Barbier
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Correspondence to J M Flack.

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Conflict of interest

JMF: grant and research support and/or is a consultant and speaker for Novartis, Merck, Pfizer, GlaxoSmithKline, AstraZeneca, Solvay, Bristol-Myers Squibb, CVRx, Genzyme, Daiichi Sankyo, and Myogen. DAC: grant and research support and/or is a consultant and speaker for Novartis, Merck, Pfizer, and AstraZeneca. LS/MB/RH/PB: employees at Novartis.

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Flack, J., Calhoun, D., Satlin, L. et al. Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study. J Hum Hypertens 23, 479–489 (2009). https://doi.org/10.1038/jhh.2008.153

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