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A post-marketing surveillance study on the safety and efficacy of valsartan (Diovan) among Filipino patients with mild to moderate essential hypertension.


Diovan Study Group,
Jesus N. Sarol Jr.,
Cynthia I. Valencia,
Raul D. Jara

Related Institution

College of Public Health - University of the Philippines Manila

Novartis Healthcare Philippines, Inc.

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Publication Information

Publication Type
Publication Sub Type
Philippine Journal of Internal Medicine
Publication Date
May-June 2003


OBJECTIVE: The objective of this study was to determine the safety, tolerability, and efficacy of valsartan (Diovan®) 80 mg tablet in the treatment of mild to moderate, uncomplicated essential hypertension in Filipino patients.
METHODS: Patients who were 18-80 years of age, male or female diagnosed with essential hypertension with mean sitting diastolic blood pressure (SDBP)> 90mmHg to 115mmHg were given valsartan  80mg tablet daily for a minimum of 2 weeks to a maximum of 8 weeks of treatment.
RESULTS: A total of 3224 evaluable patients were included in the study. Almost forty percent (39.6%) of patients are newly-diagnosed hypertensives, 25.8% have been hypertensives for 1 to 2 years,17% for 3-5 years, and 17.6% for more than 5 years. The mean systolic blood pressure (SBP) at baseline was 156.9 mmHg ± 15.4 mmHg while the mean diastolic blood pressure (DBP) at baseline was 98.7 mmHg ± 6.4 mmHg. The SBP decreased at visit 2 to a mean of 135.3 mmHg ± 12.6 mmHg which reduction was very highly significant (paired t-test= 9.13, p<0.0001). On the other hand, the mean DBP decreased to 85.3 mmHg ± 7.2 mmHg at visit 2 which reduction from baseline to visit 2 was also very highly significant (paired t-test= 94.2, p<0.0001). Adverse events in patients had been mild. Over-all the drug had demonstrated its relative safety in this population of subjects.

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