Eva Lonn1, Jackie Bosch2, Janice Pogue2, Alvaro Avezum3, Irina Chazova4, Antonio Dans5, Rafael Diaz6, George J Fodor7, Claes Held8, Petr Jansky9, Matyas Keltai10, Katalin Keltai10, Kamlesh Kunti11, Jae-Hyung Kim12, Lawrence Leiter13, Basil Lewis14, Lisheng Liu15, Patricio Lopez-Jaramillo16, Prem Pais17, Alexandr Parkhomenko18, Ron J G Peters19, Leopoldo S Piegas20, Christopher M Reid21, Karen Sliwa22, William D Toff23, John Varigos21, Denis Xavier17, Khalid Yusoff24, Jun Zhu25, Gilles Dagenais26, Salim Yusuf27. 1. Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada. Electronic address: eva.lonn@phri.ca. 2. Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada. 3. Dante Pazzanese Institute of Cardiology, São Paulo, Brazil. 4. Russian Cardiology Research Complex, Moscow, Russian Federation. 5. College of Medicine of the University of the Philippines, Manula, Philippines. 6. Fundacion ECLA, Rosario, Argentina. 7. University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 8. Department of Medical Sciences, Uppsala University, Uppsala, Sweden. 9. University Hospital Motol, Prague, Czech Republic. 10. Hungarian Institute of Cardiology, Semmelweis University, Budapest, Hungary. 11. Diabetes Research Centre, University of Leicester, Leicester, United Kingdom. 12. St. Paul's Hospital, The Catholic University of Korea, Seoul, Korea. 13. Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 14. Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel. 15. Fu Wai Hospital, Chinese Academy of Medical Sciences, Beijing, China. 16. Fundacion Oftalmolgica de Santander (FOSCAL) and Instituto Masira, Medical School, Universidad de Santander, Bucaramanga, Colombia. 17. Division of Clinical Research and Training, St. John's Research Institute, Bangalore, India. 18. Ukranian Strazhesko Institute of Cardiology, Kiev, Ukraine. 19. Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands. 20. Hospital do Coração, São Paulo, Brazil. 21. Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia. 22. Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, University of Cape Town and Soweto Cardiovascular Research Group, University of the Witwatersrand, Johannesburg, South Africa. 23. Department of Cardiovascular Sciences, University of Leicester and Leicester NIHR Biomedical Research Unit in Cardiovascular Disease, Glenfield Hospital, Leicester, United Kingdom. 24. Universiti Teknologi MARA, Selangor, Malaysia. 25. Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 26. Institut Universitaire de Cardiologie et Pneumologie de Québec, Université Laval, Québec, Canada. 27. Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.
Abstract
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).
RCT Entities:
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).
Authors: Gilles R Dagenais; Hyejung Jung; Eva Lonn; Peter M Bogaty; Mahshid Dehghan; Claes Held; Alvaro Avezum; Petr Jansky; Matyàs Keltai; Lawrence A Leiter; Patricio Lopez-Jaramillo; William D Toff; Jackie Bosch; Salim Yusuf Journal: J Am Heart Assoc Date: 2018-07-22 Impact factor: 5.501