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| December 1998, Volume 12, Number 12, Pages 861-866 |
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| Original article |
| Valsartan and hydrochlorothiazide in patients with essential hypertension. A multiple dose, double-blind, placebo controlled trial comparing combination therapy with monotherapy |
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| J R Benz1,a, H R Black2, A Graff3, A Reed4, S Fitzsimmons5 and Y Shi5 |
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1Clinical Research, Cedar Rapids, IA, USA
2Rush-Presbyterian-St Lukes Medical Center, Chicago, IL, USA
3University of Miami School of Medicine, Miami, FL, USA
4Smith and Reed Clinic, Lincoln, NB, USA
5Novartis, NJ, USA
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aCorrespondence: Dr Joan Ryder Benz, Clinical Research, 788 8th Ave SE, Cedar Rapids, IA 52401, USA Sponsorship: This study was sponsored by Novartis |
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| Abstract |
| Objective: This study compares the antihypertensive efficacy and tolerability of valsartan, a novel angiotensin II antagonist, given with hydrochlorothiazide (HCTZ) vs placebo or vs valsartan or HCTZ alone. Design: 871 adult out-patients with essential hypertension participated in this double-blind study. Patients were randomised in equal number to receive either combination therapy of valsartan (80 mg or 160 mg) and HCTZ (12.5 mg or 25 mg), or valsartan (80 mg or 160 mg) or HCTZ (12.5 mg or 25 mg) alone, or placebo. Patients were treated once daily for 8 weeks and assessed at 2, 4 and 8 weeks after randomisation. Main outcome measures: The primary efficacy variable was change from baseline in mean sitting diastolic blood pressure (MSDBP) at end-point. The secondary variable was change in mean sitting systolic blood pressure (MSSBP) from baseline to end-point. Results: All active treatments produced a statistically significant difference in MSDBP (P < 0.001) from baseline to end-point compared with placebo. similar results were obtained for mssbp. all combination regimens produced a statistically significantly greater reduction in msdpb and mssbp than the corresponding monotherapies. dizziness and headache were the most common treatment-related adverse experiences reported. hypokalaemia, associated with the use of thiazide diuretics, was more commonly reported in the higher dose hctz 25 mg groups. Conclusions: Valsartan 80 mg and 160 mg act additively with HCTZ 12.5 mg or 25 mg to lower MSDBP and MSSBP in patients with essential hypertension. The addition of HCTZ to valsartan 80 mg or 160 mg was well tolerated. |
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| Keywords |
| valsartan; angiotensin II antagonist; angiotensin receptor blocker (ARB); AT1 blocker; essential hypertension; hydrochlorothiazide |
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| Received 21 May 1998; accepted 20 August 1998 |
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| December 1998, Volume 12, Number 12, Pages 861-866 |
| Table of contents Previous Abstract Next Article PDF |
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