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ABSTRACT: This study set out to assess the safety and efficacy of amlodipine in two cohorts of patients who were attended in primary- and specialised-care centres, respectively.
Prospective, observational, multicentre pharmacovigilance study including patients aged >18 years who presented with a diagnosis of hypertension (systolic blood pressure [SBP] >or=140 mm Hg and diastolic blood pressure [DBP] >or=90 mm Hg) of >6 months' duration, which was either untreated or uncontrolled, and who were followed up by general practitioners and specialists over a period of 4-6 months.
Of the total of 4277 patients included in the study, 2520 (58.9%) were attended in primary care and 1757 (41.1%) in specialised care. 2982 patients (69.7%) were receiving monotherapy, the rest were receiving combined therapy. Over the course of the study, 308 patients (7.2%) experienced adverse events related to the study drug, mostly mild to moderate in nature. There were 20 serious events, although none was related to the study drug. By the end of the study, 1617 patients (37.8%) had achieved the therapeutic goal (SBP <140 mm Hg and DBP <90 mm Hg), with the greatest degree of control being registered among patients receiving combined therapy compared with monotherapy (38.7% vs 35.7%), and in those treated in a specialised-care setting versus a primary-care setting (43.5% vs 33.8%; p < 0.005).
Amlodipine was shown to be a well tolerated and effective drug in one in three patients, and achieved the therapeutic goal in a higher proportion of patients at specialised-care centres compared with those in primary care, and in those receiving combined therapy compared with monotherapy.
Clinical Drug Investigation 02/2006; 26(3):125-33. · 1.92 Impact Factor