OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE)
Patients aged over 80 who have high blood pressure and take two or more blood pressure lowering drugs.
Reducing the amount of drugs taken by these patients using self-monitoring of blood pressure.
• To safely reduce the amount of blood pressure medication taken by older people using self-monitoring of blood pressure.
• To see if reducing the amount of medication taken by older people results in fewer falls or other harmful events and side-effects.
• To see if reducing the number of blood pressure lowering medications can improve the quality of life of individuals entering older age.
Why is this important?
People are living longer. As a consequence, the number of people living with age-related chronic (long-term) diseases such as diabetes, kidney disease and dementia is also rising. Typically, people will have more than one age-related disease requiring treatment. We call this 'co-morbidity'. Treating patients with co-morbidity can be complex, requiring many different drugs for each condition.
Patients and carers can find this 'polypharmacy' complicated to manage and stick to. For example, correctly managing which tablets to take at what time. Polypharmacy also increases the risk of side effects, harmful drug interactions, or drugs undermining one another's therapeutic effect.
Polypharmacy can also lead to the prescription of even more drugs. For example, a doctor may not realise a patient's symptoms come from a drugs side effects or interactions, and unwittingly prescribe new drugs to counter these.
Of all the chronic conditions older patients tend to suffer from, high blood pressure is the most common. This condition increases the risk of heart attack and stroke. 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.
Research has shown that reducing blood pressure with medications can be beneficial. However, in older individuals, large reductions in blood pressure have been linked to an increased risk of falls which can lead to death. Falls can be especially important to older patients as they often mark the point at which they may no longer be able to live alone without specialist care.
Reducing the number of high blood pressure drugs a patient takes may be an ideal way of reducing both the increased risk of falls and death of elderly patients and polypharmacy.
The study will take place in the 'real-world' setting of Primary Care (GP surgeries), where its findings would be used in routine clinical care. Participants will be patients aged over 80 who have well-controlled blood pressure and take two or more blood pressure lowering drugs.
GPs, from up to 36 general practices, will identify patients suitable for the study and invite them to take part. The criteria to be included will be quite broad, rather than focussing on a narrow 'ideal' subset of the population. This means the results will be as generalisable to the wider population as possible.
Patients who agree to take part will be randomly put into 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.
Safety is a crucial part of this study. Medication reduction will first be tested on a smaller number of patients to see if it is workable without risk to patients. Those individuals whose blood pressure rises beyond safe levels will be put back on the medication they were originally prescribed. In these situations, medication reduction will be deemed unsuccessful, but this approach will reduce the likelihood of any patient in the trial suffering adverse events as a result of medication reduction.
If safe, up to 540 patients will be enrolled in the study.
Although patients and GPs will know who is and isn't in the medication reduction group, the study will be run so that those analysing the data will not. This should minimise bias in interpreting the results.
The study will last for three months. We are hoping to see less than a 10% difference in the number of patients with safe blood pressure levels at three months between the two groups.
We will also look for differences between the groups in 'adverse events' (falls, heart attacks, strokes or death), as well as quality of life using standardised surveys (EQ-5D), functional independence and frailty.
How will this benefit patients
Reducing the number of drugs taken by elderly 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. 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.