Valsartan alone and as part of combination therapy in general practice in Brazil

The objective of this study was to assess the efficacy and tolerability of valsartan (Diovan) when given alone or as part of a combination regimen in normal clinical practice, in general practice patients in Brazil. In an open, multicentre post-marketing surveillance (PMS) study, 7256 hypertensive patients were evaluated. Therapy with valsartan either as monotherapy or in combination with 12.5 mg chlorthalidone was observed for up to six months. Assessments at baseline and study endpoints included analysis of adverse events and measurement of systolic and diastolic blood pressure (BP). A total of 3855 patients (53%) received valsartan as monotherapy (mostly as 80 mg once daily), 1162 (16%) received 80 mg valsartan + 12.5 mg chlorthalidone, and 347 (4.8%) received valsartan together with other antihypertensive agents; 858 patients were not evaluable because of inadequate records. A control group of 1034 patients received other antihypertensives. Overall tolerability was high, with 98.5% of patients receiving valsartan alone, 97.7% of those receiving valsartan + chlorthalidone and 92.4% of those receiving other antihypertensives giving tolerability ratings of 'excellent' or 'good'. In this large PMS study, valsartan alone and in combination with chlorthalidone was associated with excellent safety and tolerability in general practice patients in Brazil with primary hypertension, irrespective of age, sex or concomitant diseases.