Effectiveness and Tolerability of Bisoprolol / Perindopril Single-Pill Combination in Patients With Arterial Hypertension, Stable Angina Pectoris and a History of Myocardial Infarction: the PRIDE Observational Study Results

Abstract

Aim. To evaluate the efficacy, safety and adherence to therapy with a fixed combination of bisoprolol/perindopril in patients with arterial hypertension (AH), stable ischemic heart disease (IHD), and a history of myocardial infarction (MI) in clinical practice.Material and methods. For patients with AH and concomitant stable angina and a history of MI, the treatment with beta-blockers and renin-angiotensin-aldosterone blockers is recommended as a part of therapy to reduce the risk of death from cardiovascular complications. This study included 504 patients. At baseline, systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) were 148.9±16.7 mm Hg, 87.7±11.0 mm Hg, and 77.4±10.5 beats/min, respectively. PRIDE was a multicenter, observational, ambispective study that included patients with hypertension, stable angina and a history of myocardial infarction, taking a fixed combination of bisoprolol/perindopril. The prospective observation period was 12 weeks from the date of inclusion in the study. The primary endpoint was a change in SBP and DBP at the end of the observation. Additional parameters of antihypertensive and antianginal efficacy and adherence to therapy were assessed as secondary variables. For exploratory purposes, an analysis was performed to evaluate predictors of achieving the target values of BP and HR, as well as adherence to therapy, including a fixed combination of bisoprolol/perindopril.Results. The antihypertensive effect that was observed by the 12th week of observation was evident as a decrease in SBP and DBP by 24.9/12.2 mm Hg (p<0.001). The proportions of patients with low, moderate, or high adherence to treatment at 12 weeks were 21.7% (n=94), 25.3% (n=110), and 53.0% (n=230), respectively. The presence of grade 3 AH was a negative predictor for achieving the target BP <140/90 mmHg (odds ratio, OR, 0.11; 95% confidence interval: 0.01-0.64). Functional class III angina in the general population, patients younger than 65 years, and female patients, and grade 2 and 3 AH in male patients were factors associated with a lower likelihood of high adherence. In women, the presence of type 2 diabetes mellitus was a positive predictor for adherence to therapy. Despite the fact that 3.7% (n=18) of patients included in the study had a decrease in SBP below 120 mm Hg by week 12, no adverse events associated with such a decrease was noted, and the therapy was well tolerated by the patients.Conclusion. Treatment of patients with AH in combination with stable IHD and a history of MI with a fixed combination of bisoprolol/perindopril was associated with significant antihypertensive efficacy and improved adherence to the prescribed treatment. The presence of grade 3 AH was associated with a significant decrease in the likelihood of achieving the BP goal, while grades 2 and 3 AH and functional class III angina negatively influenced the likelihood of high adherence to therapy.