C008: Opera: Design and rationale for a novel placebo control trial testing the benefits of blood pressure reduction in patients with stage I isolated systolic hypertension

• Published in: American journal of hypertension 2000-04, Vol.13 (S2), p.70A-71A
• Main Authors: Kostis, J.B., Weber, M.A., Alderman, M.H., Black, H.R., Johnston, C.I., Larochelle, P., Levy, D., Neutel, J., Wolf, R.A.
• Format: Article
• Language: English
• Subjects: atherosclerotic events; CV mortality; isolated systolic hypertension; Omapatrilat; OPERA
• ISSN: 0895-7061; 1941-7225; 1879-1905
• DOI: 10.1016/S0895-7061(00)00834-7

The percentage of hypertensive patients with controlled systolic blood pressure (SBP < 140/90 mm Hg) is only about 25%. This may be due, in part, to low levels of physician belief in the benefits of antihypertensive therapy for patients with mildly elevated SBP and suboptimal control with available agents. Although the benefits of lowering SBP in patients with Stage ≥II (SBP ≥ 160, DBP < 90 mm Hg) isolated systolic hypertension (ISH) have been demonstrated unequivocally, no randomized clinical trial to date has documented that treating Stage I ISH (SBP 140–159 mm Hg) will reduce the substantial risk for cardiovascular disease (CVD) observed at these common levels of SBP. The OPERA trial was designed to assess the benefits of treating patients with stage I ISH and other risk factors for atherosclerotic events using a new and potent antihypertensive agent, omapatrilat. The primary end point is the reduction in CVD morbidity and mortality (defined as the composite of fatal and non-fatal stroke, fatal and non-fatal myocardial infarction, fatal and non-fatal heart failure, or other CVD mortality) in men and women age ≥65 years. OPERA is a multinational, double-blind, parallel-group, placebo-controlled, forced titration study that will randomize ∼12,600 subjects. Patients not previously receiving antihypertensive therapy with seated SBP (SeSBP) ≥ 140 and