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[Intensive blood pressure reduction in patients with increased cardiovascular risk with high-dose combination therapy of 160 mg valsartan plus 25 mg hydrochlorothiazide. Results of the MACHT II observational study]

Author(s): Schuhlen H, Abts M, Kastrati D

Affiliation(s): Vivantes Auguste-Viktoria-Klinikum Berlin, Berlin. helmut.schuehlen@vivantes.de

Publication date & source: 2007-08, Herz., 32(5):419-25.

Publication type: Clinical Trial; English Abstract; Multicenter Study

BACKGROUND AND PURPOSE: Hypertension is one of the most common cardiovascular risk factors. Thus, achievement and maintenance of a sufficient reduction of blood pressure markedly contribute to successful risk prevention. Therefore, the primary objective of this observational postmarketing study MACHT II was to examine the efficacy and the tolerability of the combined therapy with 160 mg valsartan plus 25 mg hydrochlorothiazide (HCT) in a large population of patients with a well-defined individual risk profile and treatment status at baseline. PATIENTS AND METHODS: This multicenter, open singlearm trial involved 17,591 patients, either without or with insufficient prior antihypertensive medication. RESULTS: The mean absolute blood pressure improvement obtained for the total population was -26.8 mmHg systolic and -13.5 mmHg diastolic. The maximum absolute improvement in blood pressure was observed in patients with severe hypertension: on average, the systolic blood pressure decreased by 41.7 mmHg and the diastolic blood pressure by 20.5 mmHg compared to baseline. The results demonstrated an effective blood pressure reduction in every subgroup analyzed: mean values of systolic and diastolic blood pressure decreased to high normal values. More than two thirds of the patients achieved normalization of the diastolic blood pressure. Normalization of diastolic blood pressure was observed in 65.2% of the patients with previous antihypertensive medication and in 74.3% of those without previous antihypertensive medication. The overall incidence of adverse drug reactions was 0.6%. CONCLUSION: The combined antihypertensive therapy with 160 mg valsartan plus 25 mg HCT shows a high degree of efficacy and a very favorable safety profile.

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