OPTIMISE: OPtimising Treatment for MIld Systolic hypertension in the Elderly
The trial is funded by the National Institute for Health Research, Oxford Collaboration for Leadership in Applied Health Research and School for Primary Care Research. Ethics Ref: 16/SC/0628. EudraCT Number: 2016-004236-38. The OPTiMISE extension study (OPTiMISE-X) is funded by the British Heart Foundation.
Background and Study Aims
High blood pressure increases the risk of heart attack and stroke and is the most common chronic condition in older patients. More than half of patients aged 80 years or older will have high blood pressure, many of which may be taking two or more different drugs to control it.
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 high blood pressure drugs a patient takes may reduce both the increased risk of falls and death of elderly patients and polypharmacy.
- 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.
Patients over 80 years old with well-controlled blood pressure and who take two or more blood pressure lowering drugs will be invited to take part in OPTiMISE. Patients will be randomly assigned to either the medication reduction (intervention) or usual care (control) groups. The medication reduction group will have one blood pressure lowering medication removed by their GP.
They will then be shown how to measure their own blood pressure at home and asked to report to their GP immediately if levels rise too high in the following weeks. Those not willing to self-monitor will be asked to return to their GP for an additional safety visit after one month of medication reduction.
All patients will be asked to attend one follow-up visit at 12 weeks. All visits will take place at the patient's GP practice.
Collaborators: University of Cambridge, University of Southampton
Recruitment Period: March 2017 to September 2018
What we have found so far
The initial trial results showed 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 . 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 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 effect, adverse events or quality of life between groups.
The trial is now in long term follow-up and aims to examine whether there were any differences between groups in hospital admissions or general health after medication reduction. This extension study (OPTiMISE-X) is funded by the British Heart Foundation.
Over 1.2 million older patients throughout the UK are thought to be potentially eligible blood pressure lowering medication reduction right now. This number is expected to rise over the next 30 years as more and more people live beyond 80 years of age. 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 will be explored in the OPTiMISE-X long-term follow-up study. 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.
'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
Optimise Long Term Follow-up Documents
Please click on the links below to download documents (.pdf)