Abstract
Introduction
Long-term therapy with a combination of perindopril and amlodipine has shown a beneficial effect on the morbidity and mortality of patients with stable coronary artery disease (SCAD) and hypertension. On the basis of the antiproliferative, antithrombotic, and antiatherogenic effects of the active substances, we initiated data collection to examine the short-term cardioprotective effect of perindopril/amlodipine fixed-dose combination therapy in this patient group. The aim of this study was to evaluate the effect of perindopril/amlodipine fixed-dose combination on the Canadian Cardiovascular Society (CCS) class and exercise capacity of patients with SCAD in everyday medical practice.
Methods
This was a multicenter, prospective, observational, non-interventional, open-label, 6-month clinical study. Patients attended four visits (inclusion, and at months 1, 3, and 6), and clinical information was collected [risk factors, comorbidities, blood pressure (BP), and heart rate measured at the physician's office, drug treatment, CCS class, adverse events, optional laboratory blood tests, and exercise electrocardiography (ECG)].
Results
This study included 3472 patients. The mean office systolic BP/diastolic BP decreased from 157.5 ± 12.9/92.9 ± 8.6 to 130.3 ± 8.3/79.8 ± 6.1 mmHg (P < 0.0001). During the 6-month study period, a favorable change in CCS grading was observed following treatment with fixed-dose combination perindopril/amlodipine: CCS I, from 42.6% to 71.4%; CCS II, from 46.4% to 26.5%; CCS III, from 10.2% to 2.0%; and CCS IV, from 0.8% to 0.1% (all P < 0.0001). In those patients who had exercise ECG at inclusion and the end of month 6 (n = 197) the mean performance, measured in watts, increased from 88.9 ± 37.9 to 110.5 ± 38.4 W (+24.4%; P < 0.001) and from 7.86 ± 2.95 to 8.78 ± 2.92 metabolic equivalent of task (MET) (+11.7%; P < 0.001). No serious adverse events were reported and the treatment was found to have a positive impact on patients' metabolic profiles.
Conclusion
The fixed-dose combination of perindopril and amlodipine improved the CCS class and exercise capacity in patients with SCAD after 6 months of treatment. The fixed-dose combination of perindopril and amlodipine can have favorable effects on the cardiovascular system, not only by its BP-lowering effect and its effect on vascular resistance but also through its direct cardiovascular protective effects.
Funding
Egis Pharmaceuticals.
Trial registration
21938-1/2011-EKU (698/PI/11.)
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