Lege Artis Medicinae

[PErindopril-Amlodipine Reducing Blood Pressure Level Trial - The PEARL Study]

NAGY Viktor, LANTOS Éva, HABONY Norbert

AUGUST 20, 2010

Lege Artis Medicinae - 2010;20(08)

[Background and aims - In order to reach target blood pressure values more successfully and to achieve better therapeutic compliance, concomitant use of more antihypertensive agents with different mechanisms of action has gained much attention recently. In the PEARL study we investigated the antihypertensive effect of fixed dose combinations of perindopril and amlodipine (5/5, 5/10, 10/5, 10/10 mg Covercard) by measuring blood pressure values in the doctor’s office and with a 24-hour ambulatory blood pressure monitor (ABPM) in outpatients with primary, grade 1 or 2 hypertension, whose target values could not be reached with prior treatment. We also assessed changes of metabolic parameters and how patients felt themselves throughout the study. Patients and methods - In this open-label, multicentre, non-interventional, observational, 3 month long study we evaluated the data of 10 335 patients (5 483 female, 4 852 male, mean age: 61.0±12.4 years, waist circumference 99.0±13.8 cm). The mean duration of hypertension was 9.5±7.7 years. After signing the informed consent form, patients attended three visits (inclusion, months 1 and 3), and they were asked to fill in the data sheets (visit 1: gender, age, waist circumference, blood pressure and heart rate measured at the doctor’s office, duration of hypertension, risk factors, complications, accompanying diseases, previous antihypertensive treatments, complaints), laboratory blood tests and ABPM were optionally performed; visits 2 and 3: blood pressure and heart rate measured at the doctor’s office, adverse events, patient’s evaluation about the way they felt themselves, treatment, optionally performed laboratory blood tests and ABPM. Patients were asked to take perindopril-amlodipine fixed combination tablets in the mornings; the dose was increased if no normalization of blood pressure was observed. Data were analyzed with a one-sample t-test. The consistency of the different frequency distributions was tested with a Chi-square test. The two-sided level of significance was set at 5%. Results - All the parameters sensitive to treatment efficacy (blood pressure values measured on-site and with ABPM) were significantly improved with perindopril-amlodipine fixed combination treatment. Blood pressure measured at the doctor’s office reduced from 158/93 mmHg to 132/80 mmHg, while 24-hour mean blood pressure reduced from 145/84 mmHg to 128/76 mmHg (p<0.001), the diurnal index sensitive to blood pressure variability did not change and a dipper curve was observed throughout the study. Target blood pressure (<140/90 mmHg) was reached by 75.5 % of the patients. The mean dosage at the end of the study was 8 mg perindopril and 7.3 mg amlodipine. The results were consistent across subgroups of different previously received treatments and cardiovascular risks. Regarding laboratory findings, the reduction of total cholesterol from 5.67 to 5.21 mmol/L and that of LDL cholesterol from 3.18 to 2.83 mmol/L (p<0.001 for both) were of clinical importance. Eighty-five percent of the patients evaluated the way they felt themselves as excellent or improved. No serious adverse events were reported. Conclusion - Perindopril-amlodipine fixed combination can be administered effectively and safely to a large population of hypertensive patients who do not reach target blood pressure values.]

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