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Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)

BACKGROUND: The Hypertension in the Very Elderly Trial (HYVET) is a placebo controlled double blind trial of treating hypertension with indapamide Slow Release (SR) ± perindopril in subjects over the age of 80 years. The primary endpoints are stroke (fatal and non fatal). In view of the fact that th...

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Autores principales: Bulpitt, Christopher J, Peters, Ruth, Staessen, Jan A, Thijs, Lutgarde, De Vernejoul, Marie-Christine, Fletcher, Astrid E, Beckett, Nigel S
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2006
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1769508/
https://www.ncbi.nlm.nih.gov/pubmed/17177983
http://dx.doi.org/10.1186/1745-6215-7-33
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author Bulpitt, Christopher J
Peters, Ruth
Staessen, Jan A
Thijs, Lutgarde
De Vernejoul, Marie-Christine
Fletcher, Astrid E
Beckett, Nigel S
author_facet Bulpitt, Christopher J
Peters, Ruth
Staessen, Jan A
Thijs, Lutgarde
De Vernejoul, Marie-Christine
Fletcher, Astrid E
Beckett, Nigel S
author_sort Bulpitt, Christopher J
collection PubMed
description BACKGROUND: The Hypertension in the Very Elderly Trial (HYVET) is a placebo controlled double blind trial of treating hypertension with indapamide Slow Release (SR) ± perindopril in subjects over the age of 80 years. The primary endpoints are stroke (fatal and non fatal). In view of the fact that thiazide diuretics and indapamide reduce urinary calcium and may increase bone mineral density, a fracture sub study was designed to investigate whether or not the trial anti-hypertensive treatment will reduce the fracture rate in very elderly hypertensive subjects. METHODS: In the trial considerable care is taken to ascertain any fractures and to identify risk factors for fracture, such as falls, co-morbidity, drug treatment, smoking and drinking habits, levels of activity, biochemical abnormalities, cardiac irregularities, impaired cognitive function and symptoms of orthostatic hypotension. POTENTIAL RESULTS: The trial is expected to provide 10,500 patient years of follow-up. Given a fracture rate of 40/1000 patient years and a 20% difference in fracture rate, the power of the sub study is 58% to detect this difference at the 5% level of significance. The corresponding power for a reduction of 25% is 78%. CONCLUSION: The trial is well under way, expected to complete in 2009, and on target to detect, if present, the above differences in fracture rate.
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spelling pubmed-17695082007-01-16 Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET) Bulpitt, Christopher J Peters, Ruth Staessen, Jan A Thijs, Lutgarde De Vernejoul, Marie-Christine Fletcher, Astrid E Beckett, Nigel S Trials Study Protocol BACKGROUND: The Hypertension in the Very Elderly Trial (HYVET) is a placebo controlled double blind trial of treating hypertension with indapamide Slow Release (SR) ± perindopril in subjects over the age of 80 years. The primary endpoints are stroke (fatal and non fatal). In view of the fact that thiazide diuretics and indapamide reduce urinary calcium and may increase bone mineral density, a fracture sub study was designed to investigate whether or not the trial anti-hypertensive treatment will reduce the fracture rate in very elderly hypertensive subjects. METHODS: In the trial considerable care is taken to ascertain any fractures and to identify risk factors for fracture, such as falls, co-morbidity, drug treatment, smoking and drinking habits, levels of activity, biochemical abnormalities, cardiac irregularities, impaired cognitive function and symptoms of orthostatic hypotension. POTENTIAL RESULTS: The trial is expected to provide 10,500 patient years of follow-up. Given a fracture rate of 40/1000 patient years and a 20% difference in fracture rate, the power of the sub study is 58% to detect this difference at the 5% level of significance. The corresponding power for a reduction of 25% is 78%. CONCLUSION: The trial is well under way, expected to complete in 2009, and on target to detect, if present, the above differences in fracture rate. BioMed Central 2006-12-19 /pmc/articles/PMC1769508/ /pubmed/17177983 http://dx.doi.org/10.1186/1745-6215-7-33 Text en Copyright © 2006 Bulpitt et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Bulpitt, Christopher J
Peters, Ruth
Staessen, Jan A
Thijs, Lutgarde
De Vernejoul, Marie-Christine
Fletcher, Astrid E
Beckett, Nigel S
Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)
title Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)
title_full Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)
title_fullStr Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)
title_full_unstemmed Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)
title_short Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)
title_sort fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the hypertension in the very elderly trial (hyvet)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1769508/
https://www.ncbi.nlm.nih.gov/pubmed/17177983
http://dx.doi.org/10.1186/1745-6215-7-33
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