Pulse wave velocity as endpoint in large-scale intervention trial.: The Complior® study

Objective To evaluate the ability of an antihypertensive therapy to improve arterial stiffness as assessed by aortic pulse wave velocity (PWV) in a large population of hypertensive patients. Setting Sixty-nine healthcare centres, private and institutional (19 countries). Patients Subjects aged 18-79 years, with essential hypertension. A total of 2187 patients were enrolled; 1703 (52% male) completed the study: mean age = 50 +/- 12 years; mean baseline systolic/diastolic blood pressure (S/D BP) = 158 +/- 15/98 +/- 7 mmHg; mean baseline carotid-femoral PWV = 11.6 +/- 2.4 m/s. Interventions Patients were treated for 6 months, starting with perindopril (angiotensin converting enzyme (ACE) inhibitor) 4 mg once daily (OD), increased to 8 mg OD, and combined to diuretic (indapamide 2.5 mg OD) if BP was uncontrolled (> 140/90 mmHg), Results It was feasible to measure carotid-femoral PWV using the automatic device Complior (R) at inclusion, 2 and 6 months, along with conventional BP assessments in a population of 1703 patients. Significant decreases (P < 0.001) in BP (systolic: -23.7 <plus/minus> 16.8, diastolic: -14.6 +/- 10 mmHg), and carotid-femoral PWV (-1.1 +/- 1.4 m/s) were obtained at 2 and 6 months, Conclusions The Complier Study is the first study to show the feasibility of a large-scale intervention trial using PWV as the endpoint in hypertensive patients. Adequate results may be obtained using an automatic device and rigorous criteria for assessment. A long-term controlled intervention study is needed to confirm the results of the present uncontrolled trial. (C) 2001 Lippincott Williams & Wilkins.