Post-marketing surveillance study of olmesartan medoxomil (Olmetec) among Filipino patients with mild to moderate hypertension.
- Author:
Anthony LEACHON
;
Francisco TRANQUILINO
- Publication Type:Others
- Keywords:
Olmesartan MedoxomilAngiotensin Receptor BlockerHypertensionPost-marketing Surveillance
- MeSH:
None
- From:
Philippine Journal of Internal Medicine
2008;46(4):187-194
- CountryPhilippines
- Language:English
-
Abstract:
Objective: The objective of the study was to evaluate the safety and tolerability, and efficacy of olmesartan medoxomil (olmesartan) 20 mg and 40 mg tablets in a wide population of Filipino patients with mild to moderate hypertension.Methods: Three thousand twenty nine (3029) Filipino out-patients (mean age for all = 53.8 years; number of females = 1609 or 53.1 percent) with mild to moderate hypertension were enrolled in this 8-week, open-label, dose-titration post-marketing surveillance study. All subjects initially received 20 mg olmesartan once daily for 4 weeks. Patients who attained the blood pressure (BP) goal of systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg were maintained on 20 mg olmesartan; dose was up-titrated to 40 mg once daily for those who did not attain the BP goal. Safety and tolerability was assessed by incidence of adverse events and Discontinuation of medication in subjects who took at least one dose of the medicine (n = 2988). Efficacy was assessed as the mean change in blood pressure and attainment of BP goal in subjects who had baseline and post-baseline BP determination (n=2978).Results: Of the 2988 patients, there was a total of 116 reported adverse events. The more commonly reported adverse events were dizziness (n=34, 1.1 percent), headache (n=17, 0.6 percent), and cough (n = 9, 0.3 percent). The adverse events were mostly mild in nature and necessitated discontinuation of the medication in 43 patients (1.4 percent). As compared with baseline BP determination, there was significant change of both mean systolic and mean diastolic blood pressure during Week 4 (mean SBP change, -22.2 +/- 13.784 mmHg, mean DBP change, -12.1 +/- 9.019 mmHg, p
