Reduction of antihypertensive medication noninferior to usual care in elderly
Effect of Antihypertensive Medication Reduction vs Usual Care on Short-term Blood Pressure Control in Patients With Hypertension Aged 80 Years and Older- The OPTIMISE Randomized Clinical Trial
Introduction and methods
About 50% of elderly patients ≥80 years are prescribed antihypertensive therapy . But trials such as the SPRINT trial have only represented a third of older individuals in the general population , resulting in debate of how to use outcomes of these trials in older frail patients with multimorbidity . Some observational studies suggest that lower blood pressure (BP) and multiple antihypertensive therapies may be harmful in elderly patients with multimorbidity [4-6]. A personalize approach for prescription of antihypertensive medication in frail older patients has been recommended in guidelines, included deprescription to improve quality of life [7-9]. But evidence is lacking on how to achieve medication reduction and therefore research on this topic is needed.
The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMSE) trial examined a structured approach to reduce antihypertensive medication in older patients with multimorbidity and controlled systolic hypertension who were prescribed 2 or more antihypertensive medications. It had a primary case-based, randomized, unblinded, parallel group, noninferiority design and was conducted in England. 569 Participants were randomized in a 1:1 ratio to a strategy of antihypertensive medication reduction or usual care and followed for 12 weeks. Inclusion criteria were age ≥80 years, baseline SBP <150 mmHg and prescription of 2 or more antihypertensive treatment for at least 12 months.
A medication reduction algorithm was given to participating primary care physicians to help them to decide which antihypertensive drug should be removed for participants in the intervention group. The primary care physicians were also asked to follow a safety monitoring algorithm, which included to reinstate treatment if SBP was >150 mmHg or DBP >90 mmHg for more than 1 week, adverse events occurred, or signs of accelerated hypertension developed.
Primary outcome was the relative risk of SBP control (<150 mmHg) between groups at 12-week follow-up.
Participants in the intervention group took 0.6 fewer antihypertensive medications than the control group. Medication reduction was maintained in 66.3% of participant in the intervention group.
- A strategy of antihypertensive medication reduction was noninferior to usual care with regard to SBP control at 12 week (86.4% in the medication reduction group had a SBP <150 mmHg and 87.7% in the usual care group, adjusted RR 0.98, 97.5%: 0.92-∞).
- Change in SBP was 3.4 mmHg (95%CI: 1.0-5.8 mmHg) and change in DBP 2.2 mmHg (95%CI: 0.9-3.6) higher in the intervention group than in the control group.
- There were no statically significant differences between groups in frailty, quality of life, adverse effects or serious adverse events at 12 weeks.
- Number of patients experiencing >1 adverse event was higher in the intervention group than the control group (adjusted RR 1.28 [95%CI: 1.06-1.54
The OPTIMSE trial in elderly patients aged 80 or older demonstrated that an approach of reducing antihypertensive medications was as good as usual care when looking at SBP control (defined as <150 mmHg) at 12 week follow-up. These results suggest that antihypertensive medication reduction can be achieved in older patients on multiple antihypertensive medications without change in SBP control, but data was limited to 12 weeks.