OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): feasibility study for a randomised controlled trial
Recent evidence suggests that larger blood pressure reductions and multiple antihypertensive prescriptions may be harmful in older people, particularly frail individuals with polypharmacy and multi-morbidity. However, there is a lack of evidence to support deprescribing of antihypertensives which limits the practice in routine clinical care. The aim of this study was to assess the feasibility of a trial examining whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up.
This feasibility trial used a primary care based, open label, randomised controlled trial design. Eligible patients were aged >80 years, with a systolic blood pressure <150mmHg, receiving ≥2 antihypertensive medications and had no compelling indication for medication continuation. Consenting patients were randomised to a strategy of medication reduction (intervention) or usual care (control) and followed-up for 12 weeks. Those in the intervention group had one antihypertensive medication of the treating GP’s choice stopped. The primary outcome was to determine practice and patient recruitment rates for the main trial. Consent visits were audio-recorded and examined using thematic analysis to inform ongoing trial recruitment procedures.
Sixteen practices were recruited over a 7 month period, inviting 942 patients. A total of 118 patients attended a baseline consent visit and 90 (9.6% of those invited) were randomised into the study. Reasons for ineligibility at baseline were blood pressure being too high, taking too few medications or the GP deciding medication reduction was not appropriate (i.e. lack of equipoise). Follow-up visits were completed in 88 patients (97.8% follow-up). Participants were mostly female (60%), with a mean age 84.7±3.5 years and a mean blood pressure of 133/70±12/9 mmHg. They were taking an average of 2.6 antihypertensive medications and the most common co-morbidity was chronic kidney disease (25.6%). Participants were generally fit (eFI score 0.1±0.1), with low levels of disability (mRS score 1.6±1.0).
This study found that a trial of medication reduction in older patients is feasible, but those enrolled were generally less frail and more independent that originally planned. The main trial is now underway and recruitment procedures have been altered to capture a sicker population. Completion is anticipated at the end of 2018.