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
Open accessAbstract
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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The evidence for the safety and efficacy of deintensification protocols in older adults is growing for both glucose and blood pressure management and is clearly relevant for palliative care.
“The evidence for the safety and efficacy of deintensification protocols in older adults is growing for both glucose and blood pressure management (97,134) and is clearly relevant for palliative care.”
From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [134]
The Primary Outcome section reports that antihypertensive medication reduction was noninferior to usual care for blood-pressure control at 12 weeks, supporting the blood-pressure part of the claim. The Discussion says the trial was not powered to detect differences in adverse effects, and the Subgroup Analyses report more adverse events in the reduction group; this paper therefore does not establish safety. The separate glucose-management citation and the citing authors’ palliative-care framing are not assessed here. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe evidence for the safety and efficacy of deintensification protocols in older adults is growing for both glucose and blood pressure management and is clearly relevant for palliative care.
“The evidence for the safety and efficacy of deintensification protocols in older adults is growing for both glucose and blood pressure management (104,153) and is clearly relevant for palliative care.”
From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [153]
The Primary Outcome section reports that antihypertensive medication reduction was noninferior to usual care for blood-pressure control at 12 weeks in patients aged 80 or older. The Discussion says the trial was not powered to detect differences in adverse effects, and the Subgroup Analyses report more adverse events in the reduction group, so it does not establish safety. Glucose management is covered by the sentence’s other citation; relevance to palliative care is the citing authors’ framing. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe evidence for the safety and efficacy of deintensification protocols in older adults is growing for both glucose and blood pressure management and is clearly relevant for palliative care.
“The evidence for the safety and efficacy of deintensification protocols in older adults is growing for both glucose and blood pressure management (113,174) and is clearly relevant for palliative care.”
From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [174]
The Primary Outcome section reports that antihypertensive medication reduction was noninferior to usual care for blood-pressure control at 12 weeks in patients aged 80 or older, supporting the blood-pressure portion of the claim. The Subgroup Analyses report significantly more adverse events after reduction, and the Discussion says the trial could not establish longer-term benefits or harms. This paper therefore contributes short-term efficacy evidence, but does not establish the safety of deintensification protocols more broadly. (LLM, conf=0.84)
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- Authors
- Sheppard, J. P., Burt, J., Lown, M., Temple, E., Lowe, R., Fraser, R., Allen, J., Ford, G. A., Heneghan, C., Hobbs, F. D. R., Jowett, S., Kodabuckus, S., Little, P., Mant, J., Mollison, J., Payne, R. A., Williams, M., Yu, L.-M., McManus, R. J., & for the OPTIMISE Investigators
- Affiliations
- University of Oxford (GB)
- University of Cambridge (GB)
- University of Southampton (GB)
- Oxford University Hospitals NHS Trust (GB)
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
- University of Birmingham (GB)
- University of Bristol (GB)
- Patient and public involvement representative, London, United Kingdom
- Corresponding author
- Sheppard, James P.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2020-05-26
- Volume
- 323
- Issue
- 20
- Pages
- 2039
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC7251449
- OpenAlex
- W3030513959
- Cited by
- 192
- References
- 5
- Citations by year
- 2026: 32 · 2025: 26 · 2024: 35 · 2023: 31 · 2022: 26 · 2021: 32 · 2020: 8 · 2019: 1
- FWCI
- 12.85
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Bristol Research (University of Bristol) (submittedVersion, other-oa)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- Funders
- Wellcome Trust (211182/Z/18/Z)
- National Institute for Health and Care Research (NIHR‐RP‐R2‐12‐015, NIHR200201, NIHR-RP-02-12-015)
- Department of Health and Social Care
- University of Southampton
- University of Oxford
- Curtin University of Technology
- Oxford Health NHS Foundation Trust
- NIHR Oxford Biomedical Research Centre
- NIHR School for Primary Care Research
- Topics
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- antihypertensive medication reduction, deprescribing, hypertension, older adults, systolic blood pressure control, polypharmacy, multimorbidity, primary care, non-inferiority, adverse events, frailty, quality of life, antihypertensive drugs, usual care comparison
- MeSH terms
- Deprescriptions, Aged, 80 and over, Antihypertensive Agents, Blood Pressure, Female, Humans, Hypertension, Male, Polypharmacy
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