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Randomized Controlled Trial
. 2020 May 26;323(20):2039-2051.
doi: 10.1001/jama.2020.4871.

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

James P Sheppard  1 , Jenni Burt  2 , Mark Lown  3 , Eleanor Temple  1 , Rebecca Lowe  1 , Rosalyn Fraser  1 , Julie Allen  1 , Gary A Ford  4 , Carl Heneghan  1 , F D Richard Hobbs  1 , Sue Jowett  5 , Shahela Kodabuckus  5 , Paul Little  6 , Jonathan Mant  7 , Jill Mollison  1 , Rupert A Payne  8 , Marney Williams  9 , Ly-Mee Yu  1 , Richard J McManus  1 ; OPTIMISE Investigators
Affiliations
Randomized Controlled Trial

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

James P Sheppard et al. JAMA. .

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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Conflict of interest statement

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.

Figures

Figure.
Figure.. Recruitment, Randomization, and Analysis Population
aParticipants were required to be aged 80 years or older with controlled systolic blood pressure at baseline (<150 mm Hg) and prescribed 2 or more antihypertensive treatments for at least 12 months. Patients with a history of heart failure due to left ventricular dysfunction or myocardial infarction or stroke in the preceding 12 months, secondary hypertension, or lacking in capacity to consent were excluded. bParticipants were allocated to one of the 2 study groups using a nondeterministic minimization algorithm, minimized for site and baseline systolic blood pressure. The first 3 participants were allocated using simple randomization with subsequent participants allocated with a probability at 0.8 to ensure balance across the groups. cA notes review was conducted in a further 25 patients (11 in the medication reduction group and 14 in the usual care group) who did not attend 12-week follow-up to obtain data available in the electronic health record (eg, medical history, prescriptions).
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