Eficacia y seguridad en la vida real de amlodipino/irbesartán en combinación fija en el tratamiento de la hipertensión en América Latina: estudio PARCERIA

Introduction: Latin American population-based studies have shown suboptimal blood pressure control rates. Fixed-dose anti-hypertensive combinations are associated with improved convenience, adherence and effectiveness compared with mo-notherapy. Objective: assessed the real-life effectiveness and safety of fixed amlodipine/irbesartan combination in long-term management of hypertension in Argentina, Chile, Colombia, Guatemala, and Mexico. Materials and method: this was a 48-week, prospective, observational, single-cohort study, which included adults with uncontrolled hypertension, treated with fixed amlodipine/irbesartan combination per the treating physician’s judgment, were followed in routine care. Target blood pressure was < 140/90 mmHg (< 130/80 mmHg for patients with diabetes or renal disease). Results: 509 patients (57.6% females) were included. Mean (SD) age and Framingham 10-year risk-score were 60.6 (12.5) years and 9.9 (8.78), respec-tively. Over 48 weeks, 97.4% of patients took ≥ 80% of prescribed doses. Statistically significant and clinically important blood pressure improvements (–25.7/–13.5 mmHg; p < 0.001) were observed. Control was achieved by 62.7% of patients. Treatment compliance was one of the significant (p < 0.05) predictors of target blood pressure achievement. Eighty-seven (17.1%) patients experienced 117 treatment-emergent adverse events, including 7 serious events by 5 (1.0%) patients. Adverse events were generally mild (75.2%) and judged not to be treatment-related (76.1%). The most common adverse events were peripheral edema (3.9% of patients) and dizziness (1.0%). Based on Kaplan-Meier estimates, the mean (SE) time to adverse event-related discontinuation was 32.85 (0.08) weeks. Conclusion: Treatment with the fixed-dose combination of irbesartan/amlodipine demonstrated clinical effectiveness, with a significant improvement in blood pressure values and a higher rate of achieving the treatment goal in those who adhered to the regimen. The treatment was well-tolerated, with a low per-centage of treatment-related adverse events, and few severe events. The fixed-dose combination is an important tool in the management of arterial hypertension.