SHORT-TERM SAFETY OF ANTIHYPERTENSIVE MEDICATION REDUCTION IN MULTI-MORBID PATIENTS WITH MILD HYPERTENSION: THE OPTIMISE RANDOMISED CONTROLLED NON-INFERIORITY TRIAL

Abstract

Objective: Deprescribing of antihypertensive medications is recommended in some elderly patients with polypharmacy and multi-morbidity. However, the evidence base for this strategy is limited. We aimed to establish whether antihypertensive medication reduction is possible without significant hazard or changes in systolic blood pressure (SBP) control at 12-week follow-up. Design and method: This study used a randomised, controlled, open label, non-inferiority trial design. Participants aged at least 80 years with SBP < 150 mmHg and receiving 2 or more antihypertensive medications, whose GP considered appropriate for medication reduction were recruited from 69 general practices across England. Those enrolled were randomised (1:1 ratio) to antihypertensive medication reduction (intervention) or usual care (control). The primary outcome was difference (<10%) in proportion of participants with clinically acceptable SBP (<150 mmHg) at 12-week follow-up. Secondary outcomes included difference in SBP and adverse events. Trial registration EudraCT (2016-004236-38), ISRCTN (97503221). Results: Of 569 participants who were randomised, 35 (6%) were lost to follow-up. Overall, 229 (86.4%) patients in the intervention group and 236 (87.7%) patients in the control group had clinically acceptable systolic blood pressure at follow-up (Adjusted RR 0.98, 95% CI 0.92 to 1.04). Since the lower 95% confidence interval was greater than 0.9, medication reduction was assumed to be non-inferior to usual care. Medication reduction was sustained in 187 (66.3%) participants in the intervention group who were taking 0.63 (95% CI 0.56 to 0.71) fewer antihypertensive medications than the control group at 12 weeks. Systolic blood pressure corrected for baseline was 3.5 mmHg higher (95% CI 1.1 to 5.9 mmHg) in the intervention group. Adverse events were higher in the intervention group but there was no significant difference in rates of serious adverse events. Conclusions: Antihypertensive medication reduction can be achieved in two thirds of older multi-morbid patients with systolic blood pressure remaining within clinically acceptable limits. However, potential benefits must be balanced against the possible harms from increased systolic blood pressure (and therefore cardiovascular risk) plus increased adverse events (although most were apparently unrelated).