Valsartan alone and in combination with hydrochlorothiazide in general practice - Results from two postmarketing surveillance studies involving 54 928 patients with essential hypertension

Objectives: To assess the efficacy and tolerability of valsartan and valsar tan plus hydrochlorothiazide (HCTZ), given alone or as part of a combinatio n regimen with other antihypertensive agents, in a large number of general practice patients with essential hypertension. Design: In two open, noncomparative, multicentre postmarketing surveillance (PMS) studies, 26 488 patients were treated with valsartan for 6 months (t rial 1) and 28 440 with the fixed combination valsartan/HCTZ for 3 months ( trial 2). Main Outcome Measures: Assessments at baseline and study endpoints included systolic (SBP) and diastolic blood pressures (DBP), and analysis of advers e events. Results: A total of 15 867 patients (61.0%) in trial 1 received valsartan ( mostly as 80mg once daily) and 21 558 patients (75.8%) in trial 2 received valsartan/HCTZ (80/12.5mg once daily) without additional antihypertensive a gents. In the two studies, marked reductions in SEP and DBP were observed [ mean SEP -29.5mm Ng (trial 1) and -27.3mm Hg (trial 2,); mean DBP -15.6mm H g (trial 1) and -14.7mm Hg (trial 2)]. The results were almost identical in patients treated with valsartan alone or valsartan/HCTZ, compared with tho se who also received additional antihypertensive agents. Overall, tolerabil ity was excellent, with 97.5% of patients in trial 1 and 99.3% of patients in trial 2 reporting no adverse events. Hitherto unknown adverse effects we re not observed. Conclusions: In these large PMS studies, valsartan and valsartan/HCTZ demon strated excellent efficacy and tolerability in general practice patients wi th primary hypertension, irrespective of age, gender, concomitant diseases or severity of the underlying hypertension.