TY - JOUR
T1 - Novel Approaches in Primary Cardiovascular Disease Prevention
T2 - The HOPE-3 Trial Rationale, Design, and Participants' Baseline Characteristics
AU - Lonn, Eva
AU - Bosch, Jackie
AU - Pogue, Janice
AU - Avezum, Alvaro
AU - Chazova, Irina
AU - Dans, Antonio
AU - Diaz, Rafael
AU - Fodor, George J.
AU - Held, Claes
AU - Jansky, Petr
AU - Keltai, Matyas
AU - Keltai, Katalin
AU - Kunti, Kamlesh
AU - Kim, Jae Hyung
AU - Leiter, Lawrence
AU - Lewis, Basil
AU - Liu, Lisheng
AU - Lopez-Jaramillo, Patricio
AU - Pais, Prem
AU - Parkhomenko, Alexandr
AU - Peters, Ron J G
AU - Piegas, Leopoldo S.
AU - Reid, Christopher M.
AU - Sliwa, Karen
AU - Toff, William D.
AU - Varigos, John
AU - Xavier, Denis
AU - Yusoff, Khalid
AU - Zhu, Jun
AU - Dagenais, Gilles
AU - Yusuf, Salim
PY - 2016/3/1
Y1 - 2016/3/1
N2 - Background: Cholesterol and blood pressure (BP) can be effectively and safely lowered with statin drugs and BP-lowering drugs, reducing major cardiovascular (CV) events by 20%-30% within 5 years in high-risk individuals. However, there are limited data in lower-risk populations. The Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial is evaluating whether cholesterol lowering with a statin drug, BP lowering with low doses of 2 antihypertensive agents, and their combination safely reduce major CV events in individuals at intermediate risk who have had no previous vascular events and have average cholesterol and BP levels. Methods: A total of 12,705 women 65 years or older and men 55 years or older with at least 1 CV risk factor, no known CV disease, and without any clear indication or contraindication to the study drugs were randomized to rosuvastatin 10 mg/d or placebo and to candesartan/hydrochlorothiazide 16/12.5 mg/d or placebo (2 × 2 factorial design) and will be followed for a mean of 5.8 years. The coprimary study outcomes are the composite of CV death, nonfatal myocardial infarction (MI), and nonfatal stroke and the composite of CV death, nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. Results: Participants were recruited from 21 countries in North America, South America, Europe, Asia, and Australia. Mean age at randomization was 66 years and 46% were women. Conclusions: The HOPE-3 trial will provide new information on cholesterol and BP lowering in intermediate-risk populations with average cholesterol and BP levels and is expected to inform approaches to primary prevention worldwide (HOPE-3 ClinicalTrials.gov NCT00468923).
AB - Background: Cholesterol and blood pressure (BP) can be effectively and safely lowered with statin drugs and BP-lowering drugs, reducing major cardiovascular (CV) events by 20%-30% within 5 years in high-risk individuals. However, there are limited data in lower-risk populations. The Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial is evaluating whether cholesterol lowering with a statin drug, BP lowering with low doses of 2 antihypertensive agents, and their combination safely reduce major CV events in individuals at intermediate risk who have had no previous vascular events and have average cholesterol and BP levels. Methods: A total of 12,705 women 65 years or older and men 55 years or older with at least 1 CV risk factor, no known CV disease, and without any clear indication or contraindication to the study drugs were randomized to rosuvastatin 10 mg/d or placebo and to candesartan/hydrochlorothiazide 16/12.5 mg/d or placebo (2 × 2 factorial design) and will be followed for a mean of 5.8 years. The coprimary study outcomes are the composite of CV death, nonfatal myocardial infarction (MI), and nonfatal stroke and the composite of CV death, nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. Results: Participants were recruited from 21 countries in North America, South America, Europe, Asia, and Australia. Mean age at randomization was 66 years and 46% were women. Conclusions: The HOPE-3 trial will provide new information on cholesterol and BP lowering in intermediate-risk populations with average cholesterol and BP levels and is expected to inform approaches to primary prevention worldwide (HOPE-3 ClinicalTrials.gov NCT00468923).
UR - http://www.scopus.com/inward/record.url?scp=84959279879&partnerID=8YFLogxK
U2 - 10.1016/j.cjca.2015.07.001
DO - 10.1016/j.cjca.2015.07.001
M3 - Article
C2 - 26481083
AN - SCOPUS:84959279879
SN - 0828-282X
VL - 32
SP - 311
EP - 318
JO - Canadian Journal of Cardiology
JF - Canadian Journal of Cardiology
IS - 3
ER -