Results not yet available as this paper reports the protocol; primary outcome is to determine non-inferiority of deprescribing antihypertensives with up to 5% difference in emergency hospitalisation or death at 1 year.
RCT (n=3,014)
Open-label; patients and practitioners not blinded, analysis blinded
Individual randomization, 1:1 ratio with stratification by age group (75-79 and ≥80 years) and region
Yes
Does step-down antihypertensive medication reduction reduce emergency hospitalisation or death in older adults with controlled hypertension and frailty?
The OPTIMISE2 trial protocol outlines a study to determine whether deprescribing antihypertensive medications in older, frail adults is non-inferior to usual care for preventing emergency hospitalizations and death.
Abstract Background Antihypertensive treatment is effective at reducing the risk of cardiovascular disease, but is associated with adverse events, particularly in older patients with frailty. As a result, deprescribing antihypertensive medications is recommended in some clinical guidelines despite limited evidence from a few small randomised controlled trials. The aim of the OPTIMISE2 trial is to examine the safety, efficacy and cost-effectiveness of deprescribing antihypertensive treatment in older adults with controlled systolic blood pressure, who are at higher risk of adverse events. Methods The OPTIMISE2 trial aims to enrol 3014 participants into the trial and actively follow them up for 1 year. Participants are aged 75 years and above and taking two or more blood pressure lowering drugs, with controlled blood pressure readings (systolic blood pressure < 140 mmHg if aged 75–79 years or < 150 mmHg if aged 80+ years), frail and/or at a higher risk of serious drug-related side effects of hypotension, syncope and falls. The trial randomises (1:1) participants to either step-down medication reduction (withdrawal of one antihypertensive medication at a time, at 4-week intervals with regular monitoring of blood pressure) or usual care (no medication reduction mandated). The choice of medications to withdraw is at the discretion of participating general practitioners or prescribers. The primary outcome is emergency hospitalisation or death within 1 year of randomisation. The primary objective is to determine whether antihypertensive deprescribing is non-inferior to usual care, with up to a 5% difference in the percentage of patients with an emergency hospitalisation/death. The study uses a within-trial economic evaluation and decision-analytic modelling to estimate the cost-effectiveness of deprescribing antihypertensive treatment. Discussion It is expected that these findings will inform clinical guidelines and practice about deprescribing of antihypertensive medications in older adults with frailty, who have controlled systolic blood pressure but are at higher risk of adverse events. Trial registration ISRCTN18030225. Registered on 19/09/2023. Secondary Identifying Numbers: University of Oxford Sponsor Protocol Number 16667. IRAS 1006598. CPMS 56390.
Carr et al. (Sat,) conducted a rct in Adults aged 75 years and above with controlled systolic blood pressure (<140 mmHg if 75-79 years; <150 mmHg if ≥80 years), taking two or more antihypertensive medications for at least 12 months, with moderate or severe frailty (eFI ≥ 0.20) and/or high risk (>5%) of hypotension, syncope or falls (n=3,014). Step-down antihypertensive medication reduction vs. Usual care with no mandated medication reduction was evaluated on Composite of emergency hospitalisation or all-cause death within 1 year of randomisation. Results not yet available as this paper reports the protocol; primary outcome is to determine non-inferiority of deprescribing antihypertensives with up to 5% difference in emergency hospitalisation or death at 1 year.