TREATMENT OF HYPERTENSION WITH COMBINATION OF IRBESARTAN AND AMLODIPINE: A REAL-LIFE OBSERVATION STUDY (ON-TRACK STUDY)

Abstract

Objective: The On-Track study (Old versus New blood pressure TaRget Achievement under Irbesatan/Amlodipine Combination: General Practice WorK experience) is a real life study conducted to evaluate the fixed combination of Irbesartan and Amlodipine. The aim of this study was to assess the efficacy of the fixed combination Irbesartan/Amlodipine in reducing blood pressure (BP) and achieving target BP and its safety profile. Design and method: This is an observational, prospective, multicenter study which included patients with newly diagnosed and untreated hypertension (BP higher or equal to 140/90 mmHg) or uncontrolled hypertension on monotherapy or uncontrolled hypertension with any two-drug combination other than irbesartan/Amlodipine. Patients included were prescribed the combination drug Irbesartan/Amlodipin at different doses and followed up for 6 months. Results: A total of 1012 patients were included in this study in the intention-to-treat analysis. 536 patients were treated with Irbesartan/Amlodipine 150/5, 421 patients with Irbesartan/Amlodipine 300/5, and 55 patients with Irbesartan/Amlodipine 300/10. Systolic and diastolic blood pressure (SBP and DBP) values were recorded for patients at inclusion and at each study visit. There was a significant decrease of mean SBP at 6 months compared to SBP at inclusion ( 167.4±16.8 mm Hg 128.6±8.5 mm Hg, p<0.001) and of DBP ( 91.7±10.0 mmHg vs 76.4±6.2 mmHg p < 0.001). At six months the target BP of < 140/90 mm Hg was achieved in 87.1 % of patients, and the target BP < 130/80 mm Hg was achieved in 39.5 % of patients. The rate of adherence to treatment was 88.5 %. Adverse events were reported in 22.3 % of patients mainly oedema in 11 % of cases. None of the patients in the study reported a serious adverse event that would have led to discontinuation of treatment Conclusions: This study confirms the efficacy of the irbesartan-amlodipine fixed-dose combination when applying the old targets of BP but more efforts should be done to achieve new target BP. We noticed a good tolerability and adherence to treatment of patients under this drug combination.