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OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial

OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial
OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial
Introduction: recent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multi-morbidity. However, there is a lack of evidence to support de-prescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up.
Methods and analysis: this trial will use a Primary Care based, open label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mmHg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, co-morbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12 week follow-up (defined as a systolic blood pressure <150mmHg) which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long term effects of any observed changes in blood pressure and quality-of-life.
2044-6055
Little, Paul
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sheppard, james p
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Burt, Jenni
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Lown, Mark
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Temple, Eleanor
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benson, john
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Ford, Gary A
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Heneghan, Carl
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Hobbs, FD Richard
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Jowett, Sue
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Mant, Jonathan
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Mollison, Jill
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Nickless, Alecia
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Ogburn, Emma
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Payne, Rupert
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Williams, Marney
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Yu, Ly-Mee
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McManus, Richard J.
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Little, Paul
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sheppard, james p
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Burt, Jenni
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Lown, Mark
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Temple, Eleanor
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benson, john
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Ford, Gary A
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Heneghan, Carl
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Hobbs, FD Richard
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Jowett, Sue
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Mant, Jonathan
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Mollison, Jill
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Nickless, Alecia
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Ogburn, Emma
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Payne, Rupert
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Williams, Marney
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Yu, Ly-Mee
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McManus, Richard J.
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Little, Paul, sheppard, james p, Burt, Jenni, Lown, Mark, Temple, Eleanor, benson, john, Ford, Gary A, Heneghan, Carl, Hobbs, FD Richard, Jowett, Sue, Mant, Jonathan, Mollison, Jill, Nickless, Alecia, Ogburn, Emma, Payne, Rupert, Williams, Marney, Yu, Ly-Mee and McManus, Richard J. (2018) OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial. BMJ Open. (doi:10.1136/bmjopen-2018-022930).

Record type: Article

Abstract

Introduction: recent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multi-morbidity. However, there is a lack of evidence to support de-prescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up.
Methods and analysis: this trial will use a Primary Care based, open label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mmHg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, co-morbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12 week follow-up (defined as a systolic blood pressure <150mmHg) which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long term effects of any observed changes in blood pressure and quality-of-life.

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OPTiMISE protocol paper_10.08.18_revised - Accepted Manuscript
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Accepted/In Press date: 18 August 2018
e-pub ahead of print date: 4 October 2018

Identifiers

Local EPrints ID: 424498
URI: http://eprints.soton.ac.uk/id/eprint/424498
ISSN: 2044-6055
PURE UUID: 0cecd565-e7b6-441d-8d6c-b1c696f5aeb5
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Mark Lown: ORCID iD orcid.org/0000-0001-8309-568X

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Date deposited: 05 Oct 2018 11:37
Last modified: 12 Jul 2024 01:52

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Contributors

Author: Paul Little ORCID iD
Author: james p sheppard
Author: Jenni Burt
Author: Mark Lown ORCID iD
Author: Eleanor Temple
Author: john benson
Author: Gary A Ford
Author: Carl Heneghan
Author: FD Richard Hobbs
Author: Sue Jowett
Author: Jonathan Mant
Author: Jill Mollison
Author: Alecia Nickless
Author: Emma Ogburn
Author: Rupert Payne
Author: Marney Williams
Author: Ly-Mee Yu
Author: Richard J. McManus

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