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Valsartan in the Treatment of Primary Hypertension — Polish Multicenter, Randomised Study
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Abstract
Background The aim of the study was the evaluation of valsartan’s efficacy and tolerance in patients with mild and moderate essential hypertension.
Material and Methods The research carried out in six medical centres in Poland included 93 patients (60 male, 34 female), aged 18–80 (mean age: 50), with primary hypertension, whose diastolic blood pressure (DBP) at the end of a two-week placebo treatment ranged 95–115 mm Hg. Valsartan (Diovan®, Novartis) was administered as a single daily dose of 80 mg for 8 weeks. In case of patients whose DBP did not come down below 95 mm Hg after 4 weeks, a daily dose of 12,5 mg hydrochlorothiazide was added to the treatment. Blood pressure was measured with the traditional method (standardised mercurial manometers) every 2 weeks. After the period of placebo administration (PA), and after 4 and 8 weeks of treatment, 24-hour ambulatory blood pressure measurements (APBM) were performed with a Spacelab 90121 recorder.
Results In both 4-week treatment periods, statistically significant reduction of blood pressure, as compared to the period of PA, was observed. After 8 weeks of treatment, systolic blood pressure (SBP) decreased from 156 ± ± 14,8 mm Hg to 136 ± 15 mm Hg (standard measurement), and from 144 ± 15,3 mm Hg to 134 ± 14,3 mm Hg (ABPM). DBP decreased respectively from 103 ± ± 4,4 mm Hg to 89 ± 8,9 mm Hg (standard method) and from 98 ± 12,2 to 90 ± 12,9 mm Hg in ABPM. After 8 weeks, in 61 patients who underwent only valsartan treatment, SBP decreased by 20 mm Hg on average, and DBP decreased by 16 mm Hg in standard method, and in ABPM by 9 and 8 mm Hg, respectively. After 8 weeks, in 32 patients who required combination treatment, SBP decreased by 21 mm Hg on average, and DBP decreased by 13 mm Hg in standard method, and in ABPM by 12 and 9 mm Hg, respectively. Side effects in form of headache, vertigo, general weakness and pyrosis were observed in 6 patients taking valsartan and in 8 in the combination treatment group. The side effects were moderate and withdrew as the treatment continued.
Conclusion Valsartan is an effective and well tolerated antihypertensive drug, both when administered in monotherapy and in combination with hydrochlorothiazide.
Abstract
Background The aim of the study was the evaluation of valsartan’s efficacy and tolerance in patients with mild and moderate essential hypertension.
Material and Methods The research carried out in six medical centres in Poland included 93 patients (60 male, 34 female), aged 18–80 (mean age: 50), with primary hypertension, whose diastolic blood pressure (DBP) at the end of a two-week placebo treatment ranged 95–115 mm Hg. Valsartan (Diovan®, Novartis) was administered as a single daily dose of 80 mg for 8 weeks. In case of patients whose DBP did not come down below 95 mm Hg after 4 weeks, a daily dose of 12,5 mg hydrochlorothiazide was added to the treatment. Blood pressure was measured with the traditional method (standardised mercurial manometers) every 2 weeks. After the period of placebo administration (PA), and after 4 and 8 weeks of treatment, 24-hour ambulatory blood pressure measurements (APBM) were performed with a Spacelab 90121 recorder.
Results In both 4-week treatment periods, statistically significant reduction of blood pressure, as compared to the period of PA, was observed. After 8 weeks of treatment, systolic blood pressure (SBP) decreased from 156 ± ± 14,8 mm Hg to 136 ± 15 mm Hg (standard measurement), and from 144 ± 15,3 mm Hg to 134 ± 14,3 mm Hg (ABPM). DBP decreased respectively from 103 ± ± 4,4 mm Hg to 89 ± 8,9 mm Hg (standard method) and from 98 ± 12,2 to 90 ± 12,9 mm Hg in ABPM. After 8 weeks, in 61 patients who underwent only valsartan treatment, SBP decreased by 20 mm Hg on average, and DBP decreased by 16 mm Hg in standard method, and in ABPM by 9 and 8 mm Hg, respectively. After 8 weeks, in 32 patients who required combination treatment, SBP decreased by 21 mm Hg on average, and DBP decreased by 13 mm Hg in standard method, and in ABPM by 12 and 9 mm Hg, respectively. Side effects in form of headache, vertigo, general weakness and pyrosis were observed in 6 patients taking valsartan and in 8 in the combination treatment group. The side effects were moderate and withdrew as the treatment continued.
Conclusion Valsartan is an effective and well tolerated antihypertensive drug, both when administered in monotherapy and in combination with hydrochlorothiazide.
Keywords
mild and moderate primary hypertension; valsartan; ABPM
About this articleTitle
Valsartan in the Treatment of Primary Hypertension — Polish Multicenter, Randomised Study
Journal
Issue
Article type
Original paper
Pages
187-194
Published online
2000-07-20
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975
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Bibliographic record
Nadciśnienie tętnicze 2000;4(3):187-194.
Keywords
mild and moderate primary hypertension
valsartan
ABPM
Authors
Joanna Niegowska
Kalina Kawecka-Jaszcz
Danuta Czarnecka
Andrzej Tykarski
Krzysztof Klimek
Zbigniew Czyż
Grzegorz Dutkiewicz
Wojciech Kosmala
Maria Pietrzak-Nowacka
Anna Posadzy-Małaczyńska
Monika Przewłocka-Kosmala
Maciej Sosnowski
Eugeniusz Szmatłoch