Estudio de farmacovigilancia para evaluar la seguridad y la efectividad de amlodipino en pacientes ancianos hipertensos

Objective: to evaluate the safety and effectiveness of amlodipine in elderly patients with hypertension, whether newly diagnosed or previously diagnosed but not controlled with drug therapy. Method: we performed a multicentre, prospective, observational pharmacovigilance study of patients aged more than 65 years old who attended specialised units and who had either newlydiagnosed or previously-diagnosed arterial hypertension uncontrolled by drug therapy. Results: we evaluated 726 patients, of which 234 (32.2%) were newly diagnosed and 492 (67.8%) were receiving drug treatment for hypertension. The World Health Organisation (WHO)-based stratification of cardiovascular risk showed that 25.3% were in the high-risk group and that 52.4% were in the very high-risk group at the outset of the study. On conclusion of the six-month follow-up, the percentage of controlled patients (using the WHO criteria) was 45.7%. Reduction in systolic blood pressure was 30.03 mmHg (17.6%), while reduction in diastolic blood pressure was 14.96 mmHg (15.6%). Pulse pressure was reduced by 19.06 mmHg (23.1%). Forty-two patients experienced adverse events: most were mild or moderate and only 6 patients experienced severe adverse events. None of these events was related to amlodipine. Conclusions: amlodipine, whether in monotherapy or in combination with other antihypertensive drugs, is safe and effective in the control of hypertension in elderly patients with other cardiovascular risk factors.