P-181: Fixed-dose valsartan + hydrochlorothiazide combination therapy compared with amlodipine monotherapy in hypertensive patients with additional cardiovascular risk factors: The vast study

Objectives: To determine whether the combination of valsartan 160 mg and hydrochlorothiazide (HCTZ) 25 mg once-daily (od) is more effective than amlodipine 10 mg od in reducing systolic blood pressure (BP) in patients suffering from moderate hypertension combined with at least one other cardiovascular risk factor or concomitant condition. Further, to study the effects of treatment on vascular markers. Methods: A multicenter, randomized, double-blind, active-controlled, three-arm study over 24 weeks. After a two-week single-blind placebo run-in period, 1088 stage-II hypertensive patients with additional risk factors were randomized to three groups, two receiving valsartan 160 mg od and one group receiving amlodipine 5 mg od. At Week 4, HCTZ 12.5 mg and 25 mg respectively, were added to the valsartan groups and the amlodipine dose was force-titrated to 10 mg od. Patients were followed-up for a total of 24 weeks. Results: The combination of valsartan 160 mg+HCTZ 25 mg reduced systolic BP significantly (p<0.05) more than amlodipine monotherapy (least-squares mean changes from baseline 29.7±0.7 mmHg and 27.6± 0.7 mmHg, respectively). For diastolic BP the values were 11.1±0.4 mmHg and 10.8±0.4 mmHg, respectively (differences not significant). Levels of IL-6, t-PA antigen and hs-CRP were reduced with both combination therapies at week 12 (figure). Significantly more patients discontinued because of adverse events in the amlodipine group (18.2%) than in the combination-therapy groups (4.2% and 3.5%) over the 6 months treatment period. Conclusions: Valsartan 160 mg+HCTZ 25 mg is an effective and well-tolerated therapy in this patient population with possible beneficial effects on vascular marker