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Effect of Antihypertensive Medication Reduction vs Usual Care on Short-term Blood Pressure Control in Patients With Hypertension Aged 80 Years and OlderThe OPTIMISE Randomized Clinical Trial

Educational Objective
To understand the benefits and risks of medication reduction in older patients treated with antihypertensive medications.
1 Credit CME
Key Points

Question  Among older adults taking multiple antihypertensive medications, is a strategy of antihypertensive medication reduction noninferior to usual care with regard to short-term blood pressure control?

Findings  In this randomized clinical trial that included 569 patients aged 80 years and older, the proportion with systolic blood pressure lower than 150 mm Hg at 12 weeks was 86.4% in the intervention group and 87.7% in the control group (adjusted relative risk, 0.98), a difference that met the noninferiority margin of a relative risk of 0.90.

Meaning  The findings suggest antihypertensive medication reduction can be achieved without substantial change in blood pressure control in some older patients with hypertension.

Abstract

Importance  Deprescribing of antihypertensive medications is recommended for some older patients with polypharmacy and multimorbidity when the benefits of continued treatment may not outweigh the harms.

Objective  This study aimed to establish whether antihypertensive medication reduction is possible without significant changes in systolic blood pressure control or adverse events during 12-week follow-up.

Design, Setting, and Participants  The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE) study was a randomized, unblinded, noninferiority trial conducted in 69 primary care sites in England. Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included. Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019.

Interventions  Participants were randomized (1:1 ratio) to a strategy of antihypertensive medication reduction (removal of 1 drug [intervention], n = 282) or usual care (control, n = 287), in which no medication changes were mandated.

Main Outcomes and Measures  The primary outcome was systolic blood pressure lower than 150 mm Hg at 12-week follow-up. The prespecified noninferiority margin was a relative risk (RR) of 0.90. Secondary outcomes included the proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events.

Results  Among 569 patients randomized (mean age, 84.8 years; 276 [48.5%] women; median of 2 antihypertensive medications prescribed at baseline), 534 (93.8%) completed the trial. Overall, 229 (86.4%) patients in the intervention group and 236 (87.7%) patients in the control group had a systolic blood pressure lower than 150 mm Hg at 12 weeks (adjusted RR, 0.98 [97.5% 1-sided CI, 0.92 to ∞]). Of 7 prespecified secondary end points, 5 showed no significant difference. Medication reduction was sustained in 187 (66.3%) participants at 12 weeks. Mean change in systolic blood pressure was 3.4 mm Hg (95% CI, 1.1 to 5.8 mm Hg) higher in the intervention group compared with the control group. Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).

Conclusions and Relevance  Among older patients treated with multiple antihypertensive medications, a strategy of medication reduction, compared with usual care, was noninferior with regard to systolic blood pressure control at 12 weeks. The findings suggest antihypertensive medication reduction in some older patients with hypertension is not associated with substantial change in blood pressure control, although further research is needed to understand long-term clinical outcomes.

Trial Registration  EudraCT Identifier: 2016-004236-38; ISRCTN identifier: 97503221

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Corresponding Author: James P. Sheppard, PhD, Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Oxford OX2 6GG, United Kingdom (james.sheppard@phc.ox.ac.uk).

Accepted for Publication: March 21, 2020.

Author Contributions: Drs Sheppard and McManus had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Sheppard and McManus are co-chief investigators and act as guarantors for this work.

Concept and design: Sheppard, Burt, Temple, Lowe, Ford, Heneghan, Hobbs, Jowett, Little, Mant, Payne, Williams, Yu, McManus.

Acquisition, analysis, or interpretation of data: Sheppard, Burt, Lown, Fraser, Allen, Hobbs, Jowett, Kodabuckus, Mant, Mollison, Yu, McManus.

Drafting of the manuscript: Sheppard, Lown, Fraser, Allen, Kodabuckus, Little, Yu, McManus.

Critical revision of the manuscript for important intellectual content: Sheppard, Burt, Lown, Temple, Lowe, Ford, Heneghan, Hobbs, Jowett, Little, Mant, Mollison, Payne, Williams, Yu, McManus.

Statistical analysis: Fraser, Mollison, Yu.

Obtained funding: Sheppard, Burt, Heneghan, Hobbs, Jowett, Mant, Payne, Williams, Yu, McManus.

Administrative, technical, or material support: Lown, Allen, Ford, Payne, Williams.

Supervision: Sheppard, Burt, Hobbs, Little, Mant, McManus.

Other - Research facilitator responsible for data collection from participants: Lowe.

Other - Trial management: Temple.

Conflict of Interest Disclosures: Dr Sheppard reported grants from the National Institute for Health Research (NIHR) and from Wellcome Trust/Royal Society during the conduct of the study. Dr Burt reported grants from the NIHR School for Primary Care Research during the conduct of the study; current support from the Health Foundation and NIHR; and past funding and support from NIHR School for Primary Care Research and NIHR. Dr Lown reported grants from NIHR during the conduct of the study. Dr Temple reported grants from NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Oxford and NIHR School for Primary Care Research during the conduct of the study. Dr Lowe reported grants from NIHR, CLARHC Oxford and NIHR School for Primary Care Research during the conduct of the study. Dr Allen reported grants from NIHR during the conduct of the study. Dr Ford reported personal fees from Amgen, Stryker, Bayer, and Pfizer; and grants and personal fees from Medtronic outside the submitted work. Dr Heneghan reported grant funding from the NIHR Oxford Biomedical Research Centre and the NIHR School of Primary Care Research Evidence Synthesis Working Group (Project 390); and holding the positions of director of the Centre for Evidence-Based Medicine at the University of Oxford, editor-in-Chief of BMJ Evidence-Based Medicine, and an NIHR senior investigator. Dr Little reported grants from NIHR during the conduct of the study. Dr Mant reported personal fees from BMS-Pfizer outside the submitted work. Dr Payne reported grants from NIHR during the conduct of the study. Dr McManus reported grants from NIHR and other from NIHR during the conduct of the study; nonfinancial support from Omron (blood pressure monitors for research) outside the submitted work. No other disclosures were reported.

Funding/Support: This work received joint funding from NIHR CLAHRC at Oxford Health NHS Foundation Trust (P2-501) and the NIHR School for Primary Care Research (335). Drs Sheppard and McManus were funded by an NIHR professorship (NIHR-RP-R2-12-015). Dr Sheppard reports receipt of funding from the Wellcome Trust/Royal Society via a Sir Henry Dale Fellowship (211182/Z/18/Z) and an NIHR Oxford Biomedical Research Centre senior fellowship. Drs McManus, Heneghan, and Ford are supported by NIHR senior investigator awards. Dr Heneghan reports receipt of support from the NIHR School for Primary Care Research and NIHR Oxford Biomedical Research Centre. Dr Hobbs reports receipt of partial support from NIHR School for Primary Care Research, NIHR CLAHRC Oxford, and the NIHR Oxford Biomedical Research Centre. Dr Payne reports receipt of funding from NIHR for polypharmacy and medicines optimization research.

Role of the Funder/Sponsor: The University of Oxford had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: OPTIMISE investigators included the study authors and the following individuals: Alecia Nickless, Christopher Lovekin, David Judge, David Watt, Hannah Ashby, Hannah Swayze, Lazarina Engonidou, Sadie Kelly (Oxford Primary Care Clinical Trials Unit), Bethany Diment (University of Cambridge), Sarah Oliver (University of Southampton).

Participating National Institute for Health Research Clinical Research Networks: Debbie Kelly, Lydia Owen, Diane Lonsdale, Claire Winch, Sarah Wytrykowski, Katherine Priddis (Thames Valley and South Midlands); Kerry Gunner, Clare Grocutt, Julie Kennedy, Vivian Sparshott (Wessex), Clare Fletcher, Jenny Johnson, Kirsti Withington, Marie Corcoran (Eastern), Claire Brown, Elaine Butcher, Eleanor Hoverd, Pauline Darbyshire, Sarah Joshi, Susan Zhao, Tracey Davenport, Andrea Isaew, Julie Timmins, Azaria Ballintine, Somi Spannuth (West Midlands), Amy Herbert, Bethan Rees, Rwth Leach, Rose Hawkins, Emma Jennings, Lara Peniket, Hanorah Saliba (West of England).

Participating Practices and General Practitioners: Ascot Medical Centre (Edward Williams), Berinsfield Health Centre (Jonathan Crawshaw), Bicester Health Centre (Robin Fox), The Boathouse Surgery (Thomas Morgan), Bampton Medical Practice (Peter Grimwade), 27 Beaumont Street Medical Practice (Richard McManus), Botley Medical Centre (Mary Akinola), Broadshires Health Centre (Christine A'Court), The Cedars Surgery (Clare Nieland), Cookham Medical Centre (Kenney Tsoi), Church Street Practice (Matthew Gaw), Eynsham Medical Group (Ian Binnian), Hughenden Valley Surgery (Lynette Hykin), Hollow Way Medical Practice (Debbie Goldman), Jericho Health Centre (Mark O'Shea), King Edward Street Medical Practice (Brian Nicholson), Magnolia House Surgery (Kavil Patel), Medicas Health Limited (Ruth Mason), Milman Road Surgery (Aneeka Bajwa), St Clements Surgery (Hernandez), South Oxford Health Centre (Nick Wooding), Summertown Health Centre (Kyle Knox), Temple Cowley Medical Group (Elisabetta Angeleri-Rand), Chalgrove and Watlington Surgeries (Grace Ding), The Downland Practice (Chloe Evans), The Ivers Practice (Neetul Shah), Thatcham Medical Practice (Sarah Wadsworth), Woodlands Medical Centre (Adam Jones), Wokingham Medical Centre (Zishan Ali), Whaddon Medical Centre (Asim Malik), White Horse Medical Practice (Simon Cartwright), Homewell and Curlew Practice (Helen Whiting), Liphook and Liss Surgery (Anna Lalonde), Vine Medical Group (Olivia Boocock), Wareham Surgery (James Bennett), Badgerswood and Forest Surgery (Helen Sherrell), Lordshill Health Centre (Faycal Elhani), Highcliffe Medical Centre (Zelda Cheng), Cowplain Family Practice (Nicola Millen), Blackthorn Health Centre (Ali Shahsavanpour), Feltwell Surgery (Michael Pullen), Bridge Street Surgery (Clare Hambling), Little St John Street (Gary Taylor), Hoveton and Wroxham Medical Practice (Carsten Dernedde), Wansford and Kings Cliffe Practice (Amrit Takhar), Woolpit Health Centre (Richard West), Shelford Medical Practice (Chris Schramm), St Mary's Surgery (Katrina Young), Bennfield Surgery (Nick Doherty and Suparna Behura), West Heath Primary Care Centre (Gulshan Arora), Westside Medical Centre (Mark Lindsey), Eve Hill Medical Practice (David Shukla), River Brook Medical Centre, (Naresh Chauhan), Park Leys Medical Practice (Rachel Spencer), Manor Court Surgery (Farhana Lockhat), The Marches Surgery (Crispin Fisher), Winyates Health Centre (Vattakkatt Premchand), Avonside Health Centre (Sarah Colliver), Hastings House Surgery (Paul de Cates), Maypole Health Centre (Soong Loy Yap), Eden Court Medical Practice (Naresh Aggarwal), Old Priory Surgery (Mark Grocutt), Courtside Surgery (Vicky Smith), Trowbridge Health Centre (Toby Cookson), Phoenix Surgery (Naomi Vernon), West Walk Surgery (Sam Davies), Winchcombe Medical Centre (Richard Tribley), Mann Cottage Surgery (Cathy Bobrow), Chipping Campden Surgery (Rebecca Zamir).

Trial Steering Committee: Tom Robinson, MD (Chair, University of Leicester; Rod Taylor, PhD, University of Exeter; Richard Lindley, MD, University of Sydney; Peter Bower, PhD, University of Manchester; Ms Margaret Ogden (patient and public involvement representative), Ms Anita Higham (MEd, patient and public involvement representative).

Data Monitoring Committee: John Gladman, MD, Chair, University of Nottingham; Una Martin, PhD, University of Birmingham; Martyn Lewis, PhD, Keele University.

Disclaimer: The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Data Sharing Statement: See Supplement 4. Requests for sharing of deidentified individual participant data and a data dictionary defining each field in the set will be considered by the corresponding author.

Additional Contributions: The authors acknowledge the support of the Primary Care Clinical Trials Unit; staff from the NIHR Clinical Research Networks including Thames Valley and South Midlands, Eastern, Wessex, West Midlands (Central and South), and West of England; and Lucy Curtin (University of Oxford) for administrative support. Rebecca Lowe, BSc, Hannah Ashby, BSc, and Hannah Swayze, PhD (University of Oxford); Bethany Diment, PhD (University of Cambridge); and Sarah Oliver, BA (University of Southampton) worked as research facilitators recruiting and following up participants. Alecia Nickless, PhD (University of Oxford) assisted with the preparation of trial steering committee, data monitoring and ethics committee reports, and drafting of the statistical analysis plan. Margaret Ogden and Anita Higham (MEd) served as patient representatives for the trial steering committee. Additional members of the trial steering committee were Tom Robinson, MD (committee chair; University of Leicester), Rod Taylor, PhD (University of Exeter and University of Glasgow), Richard Lindley, MD (University of Sydney), and Peter Bower, PhD (University of Manchester). Members of the data monitoring committee were John Gladman, MD (committee chair; University of Nottingham), Una Martin, PhD (University of Birmingham), and Martyn Lewis, PhD (Keele University). Individuals working as part of the trial team were employed by coordinating centres in the trial. Patient representatives were compensated for their time spent attending trial management and trial steering committee meetings. All other members of the trial steering and data monitoring committees gave their time voluntarily and were only compensated for travel expenses incurred by attendance at meetings. Participating primary care physicians were reimbursed for time and costs incurred working on the trial. The authors thank the patients who participated in this study.

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