Observational study to evaluate the safety and effectiveness of a fixed dose combination of amlodipine and valsartan in the treatment of hypertension.
- Author:
Gilbert C VILELA
;
Anthony Russell T VILLANUEVA
- Publication Type:Clinical trials/Clinical investigations (RCT's)
- MeSH:
X
- From:
Philippine Journal of Internal Medicine
2012;50(1):40-46
- CountryPhilippines
-
Abstract:
Background: The treatment of hypertension usually requires the use of at least two antihypertensive agents to achieve control. The combination of amlodipine plus valsartan has been shown to be effective in treating hypertensive patients with an excellent safety and tolerability profile. Data on itsefficacy and safety in Filipino patients is lacking.Methods: This was a multi-center, observational, postmarketing surveillance (PMS) study, involving about 367 centers in the Philippines. Amlodipine/valsartan 5/80 mg, 5/160 mg or 10/160 mg daily was prescribed to the study patients for 12 weeks. Study visits were conducted every four weeks, during which assessments of blood pressure (BP), compliance and presence of adverse events were made. Patients and physicians also completed a global assessment of efficacy, tolerability and compliance at the end of the study.Results: A total of 1,677 patients were included in the analysis. The study population was middle aged (mean age 53.5 plus or minus 11.7 years) and 54.4% were females. Mean BP at the baseline visit was 160.9 plus or minus 16.4/99.3 plus or minus 9.4 mm Hg. Amlodipine/valsartan effectively reduced the BP from baseline by 34.35 plus or minus 16.60/19.35 plus or minus 10.44 mm Hg (p less than 0.001). At the end of the study, 95.29% of patients had a BP less than 140/90 mm Hg. Only 111 (5.57%) of patients reported an adverse event, of which headache and dizziness/ lightheadedness were the most common.Conclusions: The fixed dose combination of amlodipine plus valsartan is effective and safe in the treatment of hypertensive Filipino patients.
