Key result
Valsartan alone or with chlorthalidone yielded excellent or good tolerability in 98.5% and 97.7% of patients, respectively, compared to 92.4% for other antihypertensives.
Why the study?
Does valsartan alone or in combination with chlorthalidone improve tolerability and blood pressure in hypertensive patients compared to other antihypertensives?
Observational (n=7,256)
Open-label
Yes
Does valsartan alone or in combination with chlorthalidone improve tolerability and blood pressure in hypertensive patients compared to other antihypertensives?
Valsartan, either as monotherapy or in combination with chlorthalidone, is highly tolerable and safe for the management of primary hypertension in general practice.
Valsartan regimens were associated with higher tolerability in this cohort; extends real-world data but leaves superiority open for RCTs.
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.
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Jc et al. (2001) conducted an observational in Primary hypertension (n=7,256). Valsartan alone or in combination with chlorthalidone vs. Other antihypertensives was evaluated on Tolerability rating of 'excellent' or 'good'. Valsartan alone or with chlorthalidone yielded excellent or good tolerability in 98.5% and 97.7% of patients, respectively, compared to 92.4% for other antihypertensives.
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