OPTiMISE
Optimising Treatment for Mild Systolic Hypertension in the Elderly
Background and Trial Aims
High blood pressure increases the risk of heart attack and stroke and is the most common chronic condition in older people. More than half of people aged 80 years or older will have high blood pressure, many of whom may be taking two or more different drugs to control it.
Over 1.2 million older patients throughout the UK are presently thought to be taking blood pressure lowering medication. This number is expected to rise over the next 30 years as more people live beyond 80 years of age. Although reducing blood pressure with medications can be beneficial, in older individuals large reductions in blood pressure have been linked to an increased risk of falls which can lead to death. Taking multiple medications (polypharmacy) can also lead to the prescription of even more drugs.
Reducing the number of drugs taken by elderly older patients should make managing and complying with more complex medication schedules easier for patients and carers. It could also result in fewer serious falls and their associated complications, such as broken bones and hospitalisation.
This would have the combined effect of improving and prolonging quality of life for elderly patients, as well as freeing up NHS resources. If this research shows blood pressure medication reduction to be effective, it could have a significant impact on future clinical guidelines and patient care.
Objectives:
- To assess the safety of reducing medication in older patients with controlled systolic blood pressure.
- To see if reducing the number of blood pressure lowering medications can improve the quality of life of individuals entering older age.
What did the trial involve?
Patients over 80 years old with well-controlled blood pressure and who take two or more blood pressure lowering drugs were invited to take part in OPTiMISE. Participants were be randomly assigned to either the medication reduction (intervention) or usual care (control) groups. The medication reduction group had one blood pressure lowering medication removed by their GP.
They were then shown how to measure their own blood pressure at home and asked to report to their GP immediately if levels rose too high in the following weeks. Those not willing to self-monitor were asked to return to their GP for an additional safety visit after one month of medication reduction.
All participants were asked to attend one follow-up visit at 12 weeks. All visits took place at the participant's GP practice.
Trial status: Follow-up
Trial duration: 01 Jan 2017 - 31 Dec 2024
Contact Details
OXFORD
Email: optimise@phc.ox.ac.uk
Tel.: 0800 915 8543
CAMBRIDGE
Email: optimise@medschl.cam.ac.uk
Tel.: 0800 090 2355
SOUTHAMPTON
Email: optimise@soton.ac.uk
Tel.: 0800 023 4551
Protocol
What we have found so far
The initial trial results show that in some older people, it is possible for GPs to reduce the number of blood pressure lowering medications people take with limited impact on their blood pressure control or quality of life.
The trial was conducted in 69 GP surgeries across the Midlands and South of England (see embedded map to the right). A total of 569 participants aged 80 years or older with well-controlled blood pressure taking two or more antihypertensives were included in the study. Nearly all (98%) were living with at least 2 chronic conditions, bringing the average number of medications up to four per person.
The trial showed that over a period of 12 weeks, blood pressure remained well controlled (150 mm Hg or less) in 86.4% of patients in the medication reduction arm and 87.7% of patients in the usual care arm, with two thirds of those in the medication reduction group taking fewer medications at the end of the study. There were no differences in side effects, adverse events, or quality of life between groups.
The trial is now in long term follow-up and an extension trial, OPTiMISE-X, aims to examine whether there were any differences between groups in hospital admissions or general health after medication reduction. This extension trial is funded by the British Heart Foundation.
"Blood pressure medications are proven to reduce a person’s risk of stroke and heart attack, but for some, they may also cause fainting and falls or kidney problems, so called ‘adverse events’. This trial shows that when someone is concerned about the risk of adverse events, it is possible to reduce the number of tablets being taken and still achieve good blood pressure control, which is important for preventing stroke."
- Dr James Sheppard, University of Oxford
Trial Team
-
Anne Smith
Clinical Trials Manager
-
Stephanie Pollock
Clinical Trial Coordinator
Oxford Co-Investigators
-
Richard Hobbs
Head of Department
-
James Sheppard
Professor of Applied Health Data Science
Funding Details
OPTIMISE 2 is funded by the National Institute for Health and Care Research (NIHR) Oxford Collaboration for Leadership in Applied Health Research and School for Primary Care Research.
The OPTiMISE extension study (OPTiMISE-X) is funded by the British Heart Foundation.
REC: 16/SC/0628
IRAS: XXXXXX
Registration: XXXXXXX
Related Publications
Sheppard JP, Burt J, Lown M, et al. 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. JAMA. 2020;323(20):2039–2051. doi:10.1001/jama.2020.4871
Jowett Sue, Kodabuckus Shahela, et al. Cost-Effectiveness of Antihypertensive Deprescribing in Primary Care: a Markov Modelling Study Using Data From the OPTiMISE Trial. Hypertension. 2022;79:1122–1131. https://doi.org/10.1161/HYPERTENSIONAHA.121.18726
Sheppard JP, Lown M, Burt J, Ford GA, Hobbs FDR, Little P, Mant J, Payne RA and McManus RJ (2021) Blood Pressure Changes Following Antihypertensive Medication Reduction, by Drug Class and Dose Chosen for Withdrawal: Exploratory Analysis of Data From the OPTiMISE Trial. Front. Pharmacol. 12:619088. doi: 10.3389/fphar.2021.619088
Sheppard, J.P., Benetos, A. & McManus, R.J. Antihypertensive Deprescribing in Older Adults: a Practical Guide. Curr Hypertens Rep 24, 571–580 (2022). https://doi.org/10.1007/s11906-022-01215-3