OPTIMISE 2
Optimising Treatment for Mild Hypertension in Older People at Risk of Adverse Events
The OPTIMISE 2 trial will establish whether deprescribing common drugs that lower blood pressure is safe or effective in older people in the longer term (a year or more).
This is a follow-on trial to the OPTiMISE study. The OPTIMISE 2 team are looking to enrol a larger cohort and follow participants for longer.
BACKGROUND
The population of the UK is getting older and more people are living with multiple illnesses, taking lots of tablets to manage these illnesses. High blood pressure is one of the most common medical conditions in older people and many take two or more drugs to treat it.
Recent scientific studies suggest that large reductions in blood pressure, and too many drug prescriptions, may be associated with an increase in falls and death in older patients. We have previously undertaken a trial, OPTiMISE, which showed that reducing the number of blood pressure lowering drugs prescribed to older people is safe in the short term (over a three month period). However, we do not know what the longer term effects of stopping blood pressure lowering drugs are. This trial aims to assess this in people aged 75 years or older, who have blood pressure in a normal range, are taking two or more medications and are at a higher risk of drug-related side-effects.
WHO CAN PARTICIPATE?
Those aged 75 years or older and taking 2 or more blood pressure lowering drugs, but who do not have raised blood pressure readings, may be eligible to participate.
Trial status: Recruiting
Trial duration: April 2023 - December 2025
Contact Details
Email: optimise2-trial@phc.ox.ac.uk
Phone: 08081 968649
Participant Information
TRIAL AIMS
This trial will establish whether deprescribing common drugs that lower blood pressure is safe in older people. We will answer two key questions:
1. What is the effect of deprescribing blood pressure lowering drugs on hospital admissions and death?
2. Does deprescribing improve quality of life and/or save money for the NHS?
Building on our previous trial of 569 people, we will aim to enrol 3,014 participants aged 75 years or older who are taking blood pressure lowering drugs, but do not have raised blood pressure readings. We will actively follow them up for one year. We will focus on those who are frail and/or with a higher risk of serious drug related side-effects.
We will examine whether deprescribing is safe in this group by measuring how many people are admitted to hospital or die the year after having blood pressure lowering drugs withdrawn compared to those who continued with them. If the numbers are similar, deprescribing will be viewed as safe. If safe, we will continue the trial and passively follow-up participants using their electronic health records for up to 10 years (subject to further funding). We will also check if deprescribing affects quality of life and/or costs for the NHS.
WHAT DOES THE STUDY INVOLVE?
Participants will be enrolled at participating practices in England by their own GP and be required to attend a minimum of 2 appointments - a baseline assessment and one follow-up after 4 weeks. If further medications are to be stopped (for those in the intervention group) then another follow-up appointment would be required.
After one year participants will be sent a questionnaire to complete remotely and the trial team will follow-up participants passively using their electronic health records for an average of 3 years (dependent on funding).
In order to reduce the burden of travel we have designed the study with as few visits as possible, with the majority of our outcome data being gathered remotely.
WHAT ARE THE POSSIBLE BENEFITS AND RISKS OF PARTICIPATING?
Benefits:
For those in the control group, there will be no clear additional benefits for taking part in the trial. For those in the intervention group who have their medication reduced, there is the possibility that they will be less likely to fall over, or suffer other side effects which could affect their quality of life. We will not know if this is the case until after the trial is finished.
Risks:
All participants will receive normal routine care from their GP; those in the control arm will be at no further risk by taking part. As medications which lower blood pressure also lower the risk of heart attack and stroke, those in the intervention arm may be at higher risk if their blood pressure was left unchecked. However, follow-up visits with their GP will be booked at 4 weeks following medication reduction (per medication removed) and if blood pressure is seen to rise significantly, the medication will be restored rendering the likelihood of suffering an adverse event very low.
All risks are outlined in the patient information leaflet, as is a description of our data policy in order to reassure participants and provide clarity.
Trial Team
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Richard McManus
Professor of Primary Care
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James Sheppard
Professor of Applied Health Data Science
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Melanie Carr
Trial Manager
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Nicola Kenealy
Senior Trial Manager
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Stephanie Pollock
Clinical Trial Coordinator
Oxford Co-Investigators
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Richard Hobbs
Head of Department
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Simon de Lusignan
Professor of Primary Care and Clinical Informatics
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Gary Ford
Professor of Stroke Medicine
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Stavros Petrou
Academic Research Lead in Health Economics
External Co-investigators
Marney Williams Patient Representative |
Margaret Ogden Patient Representative |
Head of Ageing and Stroke Research, University of Leeds |
Professor of Primary Care Research, University of Cambridge |
Professor of Primary Care and Clinical Pharmacology, University of Exeter |
Funding Details
OPTIMISE 2 is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (UK).
REC: 23/EM/0054
IRAS: 1006598
Registration: ISRCTN18030225
Site Information
Click here to download the Site Document Package
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