Objective: This trial investigated the decrease of blood pressure, safety and tolerability of valsartan, an angiotensin-receptor blocker, alone or combined with the diuretic hydrochlorothiazide. In addition, the effect on pulse pressure, heart rate and mean blood pressure were recorded as independent markers of cardiovascular risk.
Patients and methods: 12278 hypertensive patients were treated for 12 weeks with valsartan alone or combined with hydrochlorothiazide in a multi-centre open trial. Previously established antihypertensive treatment was continued. Systolic and diastolic pressure, pulse pressure and resting heart rate were recorded at the start of the trial and at 1, 4 and 12 weeks thereafter.
Results: Data on 11447 were complete enough to be evaluated (54% males, 46% females; mean age 60.8 years). 44% of the patients were at the same time receiving other antihypertensive drugs at the start of the trial, but the numbers so treated decreased during the trial period. Systolic pressure was reduced by 27.8 mmHg. diastolic pressure by 14.7 mmHg, with a calculated reduction of pulse pressure from 71.5 to 58.7 mmHg. Heart rate was reduced by 3.4 beats. The treatment had to be stopped prematurely in 2.3% of patients because of side effects. There were no severe or life-threatening side effects.
Conclusion: Treatment with valsartan alone or combined with hydrochlorothiazide provides effective blood pressure reduction and is well tolerated. This trial suggests that, in addition to the fall in blood pressure, the independent risk factors of cardiovascular disease, pulse pressure and resting heart rate, were also reduced during administration of valsartan.