P-182: 24-hour ambulatory blood-pressure effects of valsartan + hydrochlorothiazide combinations compared with amlodipine in hypertensive patients at increased cardiovascular risk

Ruilope, Luis M. ; Heintz, Daniela ; Brandao, Andrea A. ; Stolt, Pelle ; Kandra, Albert ; Santonastaso, Massimo ; Khder, Yasser

In: American Journal of Hypertension, 2005, vol. 18, no. S4, p. 73A-73A

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    Summary
    In a randomised, double-blind trial, the effects on 24-hr ABP of the combination valsartan 160 mg od and hydrochlorothiazide (HCTZ) 25 or 12.5 mg during 24 weeks of therapy were compared with the effects of amlodipine 10 mg monotherapy (group A10) in 474 stage-II hypertensive patients with additional cardiovascular risk factors. After a two-week single-blind placebo run-in period, patients were randomised to receive valsartan 160 mg od or amlodipine 5 mg od. At Week 4, HCTZ 12.5 mg (group V160/HCTZ12.5) and 25 mg (group V160/HCTZ25) were added to the valsartan groups and in the A10 patients the amlodipine dose was force-titrated to 10 mg od. All treatments reduced BP as well as night-time and daytime BP levels from baseline. 24-hr SBP was reduced by 15.9 ±1.0 mmHg (least-squares mean change ±SE), 19.3 ±1.0 mmHg and 16.1 ±1.1 mmHg in the V160/HCTZ12.5, V160/HCTZ25 and A10 groups, respectively and 24-hr DBP was reduced by 9.3 ±0.6 mmHg, 11.4 ±0.6 mmHg and 9.6 ±0.7 mmHg in the three groups. The differences between the V160/HCTZ25 group and the A10 group were significant (p<0.05) for the changes in 24-hr systolic BP as well as for changes in daytime systolic BP and night-time diastolic BP. Control rates defined as ABPM ≤130/80 mmHg were: 48.4%, 60.8% and 50.9% in the V160/HCTZ12.5, V160/25 and A10 groups, respectively; the differences between the V160/HCTZ25 group and the other two treatment groups were significant at p<0.05. (See Figure) In conclusion, the fixed-dose combination of valsartan 160 mg + HCTZ 25 mg od is an attractive therapeutic option measured on the effects on 24-hr ABPM, night-time and daytime BP reduction and control rates in hypertensive patients at additional cardiovascular risk