부산대학교 도서관

Objectives: To assess the efficacy and tolerability of valsartan and valsartan plus hydrochlorothiazide (HCTZ), given alone or as part of a combination 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 (trial 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 adverse 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 agents. In the two studies, marked reductions in SBP and DBP were observed [mean SBP -29.5mm Hg (trial 1) and -27.3mm Hg (trial 2); mean DBP -15.6mm Hg (trial 1) and -14.7mm Hg (trial 2)]. The results were almost identical in patients treated with valsartan alone or valsartan/HCTZ, compared with those who also received additional antihypertensive agents. Overall, tolerability 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 were not observed. Conclusions: In these large PMS studies, valsartan and valsartan/HCTZ demonstrated excellent efficacy and tolerability in general practice patients with primary hypertension, irrespective of age, gender, concomitant diseases or severity of the underlying hypertension. [ABSTRACT FROM AUTHOR]