OPTIMISE 2
Optimising Treatment for Mild Hypertension in Older People at Risk of Adverse Events
Overview / 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 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.
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group by measuring how many people are admitted to hospital or die the year after having blood pressure lowering drugs withdrawn compared to those who continued with them.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.
Process
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).
Additional Information
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.
For further information please visit https://www.phctrials.ox.ac.uk/recruiting-trials/optimise-2
Participant Requirements
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