Hypertension in the Very Elderly Trial (HYVET)
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Drugs & Aging 2001; 18 (3): 151-164 1170-229X/01/0003-0151/$22.00/0 © Adis International Limited. All rights reserved.
Hypertension in the Very Elderly Trial (HYVET) Protocol for the Main Trial Christopher Bulpitt,1 Astrid Fletcher,2 Nigel Beckett,1 John Coope,3 Blas Gil-Extremera,4 Françoise Forette,5 Choudomir Nachev,6 John Potter,7 Peter Sever,8 Jan Staessen,9 Cameron Swift10 and Jaakko Tuomilehto11 1 Imperial College School of Medicine, Section of Elderly Care, Hammersmith Hospital, London, England 2 Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, England 3 The Waterhouse, Bollington, Nr. Macclesfield, England 4 Departmento de Medicina, Universidad de Granada, Avenida de Madrid, Granada, Spain 5 National Foundation of Gerontology, Hopital Broca, Center of Gerontology, Pascal, Paris, France 6 Department of Internal Medicine, Alexandrov’s University Hospital, Sophia, Bulgaria 7 Department of Medicine for the Elderly, Glenfield General Hospital, Leicester, England 8 Department of Clinical Pharmacology, NHLI St. Mary’s Campus, Paddington, London, England 9 Study Coordinating Centre, Hypertension and Cardiovascular Rehabilitation Unit, Department of Molecular and Cardiovascular Research, Catholic University of Leuven, Leuven, Belgium 10 Department of Healthcare for the Elderly, King’s College School of Medicine and Dentistry, King’s College Hospital, Dulwich, London, England 11 Department of Public Health, University of Helskinki and Diabetes and Genetic Epidemiology Unit, National Public Health Institute, Mannerheimintie, Helsinki, Finland
Abstract
A number of trials and meta-analyses have demonstrated clear benefits of blood pressure (BP) reduction in patients aged 140mm Hg. The trial will be carried out in accordance with the principles of Good Clinical Practice. We describe in detail the protocol for the main trial and discuss the reasons for the changes from the pilot, the use of the drug regimen, and the BP criteria to be used in the trial.
The benefits of treatment of patients with hypertension up to the age of 79 years with regards to the reduction in stroke and cardiovascular events have been well documented by several trials and metaanalyses over the last 15 years.[1-9] However, most of these trials have either excluded patients aged ≥80 years or recruited too few to establish the benefit to risk ratio in the very elderly. The Medical Research Council trial in the elderly[1] and the Hypertension in Elderly Patients in primary care trial[2] excluded patients over the ages of 75 and 80 years, respectively. The European Working Party on high BP in the elderly trial (EWPHE)[3] recruited patients of any age over 60 years, but only 155 patients out of the 840 recruited were ≥80 years. No benefit from treatment was shown in patients in the group aged ≥80 years. The Swedish trial in Old Patients with Hypertension (STOP-Hypertension)[4] recruited patients aged 70 to 84 years of age and of the 1627 patients recruited 269 were aged ≥80 years. Again, no ben
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