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Original Investigation
May 26, 2020

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

Author Affiliations
  • 1Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
  • 2The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, United Kingdom
  • 3Primary Care Research Group, University of Southampton, Southampton, United Kingdom
  • 4Radcliffe Department of Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
  • 5Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom
  • 6Primary Care Population Sciences and Medical Education Unit, University of Southampton, Southampton, United Kingdom
  • 7Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom
  • 8Centre for Academic Primary Care, Population Health Sciences, University of Bristol, Bristol, United Kingdom
  • 9Patient and public involvement representative, London, United Kingdom
JAMA. 2020;323(20):2039-2051. doi:10.1001/jama.2020.4871
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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