1. In this randomized clinical trial, among older nursing home residents with frailty who were being treated for hypertension with at least two antihypertensive agents, an antihypertensive medication step-down strategy was not found to have a significant effect on all-cause mortality.
2. Secondary outcomes, including major adverse cardiovascular events and measures of functional capacity, were also similar between the two groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Geriatric patients with hypertension are at high risk for cardiovascular complications and experience significant benefits from antihypertensive medications as a result. However, patients with clinically significant frailty are more likely than other patients of similar ages to experience adverse effects from these medications, with low blood pressure among this population being associated with increased cardiovascular morbidity and mortality. This raises questions regarding the optimal management of hypertension in older patients with clinically significant frailty, with some guidelines recommending gradual reduction of antihypertensive treatment in patients with low blood pressure; however, evidence regarding the risks and benefits of discontinuing medications in older adults remains limited. The present trial assessed the effect of a protocol-driven strategy of progressive reduction of antihypertensive therapies compared with usual care on all-cause mortality among nursing home residents who were 80 years of age or older with frailty. Compared with usual care, an antihypertensive medication step-down strategy did not have a significant effect on all-cause mortality. Limitations of the study included the potential for an unanticipated crossover effect, with physicians caring for patients in both groups possibly inadvertently adopting the step-down strategy in the usual-care group, and the trial being conducted in a single country, which may limit its external validity. Nevertheless, these findings provide valuable insight regarding the optimal treatment of hypertension in older patients with frailty.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: This randomized, open-label trial assessed the effect of a protocol-driven, progressive reduction in antihypertensive therapies compared with usual care on all-cause mortality. Patients 80 years of age or older with frailty who resided in a nursing home, were being treated for hypertension with at least two antihypertensive agents, and had a systolic blood pressure below 130 mm Hg were included. The primary outcome was death from any cause. A total of 1,048 patients were included in the study, with 528 assigned to the step-down group and 520 assigned to the usual-care group. Death from any cause occurred in 61.7% of patients in the step-down group, compared with 60.2% of patients in the usual-care group (hazard ratio, 1.02; 95% Confidence Interval [CI], 0.86 to 1.21; p=0.78). A composite of major adverse cardiovascular events occurred in 19.3% of patients in the step-down group compared with 17.3% of patients in the usual-care group (hazard ratio, 1.15; 95% CI, 0.84 to 1.56), and death from non-cardiovascular causes occurred in 53.8% of patients in the step-down group compared with 53.5% of patients in the usual-care group. The mean difference in the change in systolic blood pressure was 4.1 mm Hg (95% CI, 1.9 to 5.7), and the mean difference in the change in diastolic blood pressure was 1.8 mm Hg (95% CI, 0.5 to 3.0). Mean changes in measures of functional capacity and MMSE score were similar between the two groups, and serious adverse events other than those included in the primary and secondary outcomes were also generally similar between the groups. In summary, among nursing home residents 80 years of age or older with frailty and a systolic blood pressure below 130 mm Hg, an antihypertensive medication step-down strategy did not have a significant effect on all-cause mortality.
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