Effect of antihypertensive deprescribing on hospitalisation and mortality: long-term follow-up of the OPTiMISE randomised controlled trial

IF 13.4 Q1 GERIATRICS & GERONTOLOGY Lancet Healthy Longevity Pub Date : 2024-08-01 DOI:10.1016/S2666-7568(24)00131-4
James P Sheppard PhD , Eleanor Temple MSc , Ariel Wang PhD , Anne Smith , Stephanie Pollock DPhil , Prof Gary A Ford FMedSci , Prof F D Richard Hobbs FMedSci , Nicola Kenealy BSc , Prof Paul Little FMedSci , Mark Lown MRCGP , Prof Simon de Lusignan MD , Prof Jonathan Mant MD , David McCartney MRCGP , Prof Rupert A Payne FBPhS , Marney Williams BEd , Prof Ly-Mee Yu DPhil , Prof Richard J McManus PhD , OPTiMISE Investigators
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引用次数: 0

Abstract

Background

Deprescribing of antihypertensive medications is recommended for some older patients with low blood pressure and frailty. The OPTiMISE trial showed that this deprescribing can be achieved with no differences in blood pressure control at 3 months compared with usual care. We aimed to examine effects of deprescribing on longer-term hospitalisation and mortality.

Methods

This randomised controlled trial enrolled participants from 69 general practices across central and southern England. Participants aged 80 years or older, with systolic blood pressure less than 150 mm Hg and who were receiving two or more antihypertensive medications, were randomly assigned (1:1) to antihypertensive medication reduction (removal of one antihypertensive) or usual care. General practitioners and participants were aware of the treatment allocation following randomisation but individuals responsible for analysing the data were masked to the treatment allocation throughout the study. Participants were followed up via their primary and secondary care electronic health records at least 3 years after randomisation. The primary outcome was time to all-cause hospitalisation or mortality. Intention-to-treat analyses were done using Cox regression modelling. A per-protocol analysis of the primary outcome was also done, excluding participants from the intervention group who did not reduce treatment or who had medication reinstated during the initial trial 12-week follow-up period. This study is registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT2016-004236-38) and the ISRCTN Registry (ISRCTN97503221).

Findings

Between March 20, 2017, and Sept 30, 2018, a total of 569 participants were randomly assigned. Of these, 564 (99%; intervention=280; control=284) were followed up for a median of 4·0 years (IQR 3·7–4·3). Participants had a mean age of 84·8 years (SD 3·4) at baseline and 273 (48%) were women. Medication reduction was sustained in 109 participants at follow-up (51% of the 213 participants alive in the intervention group). Participants in the intervention group had a larger reduction in antihypertensives than the control group (adjusted mean difference –0·35 drugs [95% CI –0·52 to –0·18]). Overall, 202 (72%) participants in the intervention group and 218 (77%) participants in the control group experienced hospitalisation or mortality during follow-up (adjusted hazard ratio [aHR] 0·93 [95% CI 0·76 to 1·12]). There was some evidence that the proportion of participants experiencing the primary outcome in the per-protocol population was lower in the intervention group (aHR 0·80 [0·64 to 1·00]).

Interpretation

Half of participants sustained medication reduction with no evidence of an increase in all-cause hospitalisation or mortality. These findings suggest that an antihypertensive deprescribing intervention might be safe for people aged 80 years or older with controlled blood pressure taking two or more antihypertensives.

Funding

British Heart Foundation and National Institute for Health and Care Research.

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降压药减量对住院和死亡率的影响:OPTiMISE 随机对照试验的长期随访。
背景:建议对一些低血压和体弱的老年患者减量服用降压药。OPTiMISE 试验表明,与常规治疗相比,减药后 3 个月的血压控制效果没有差异。我们的目标是研究减量对长期住院率和死亡率的影响:这项随机对照试验招募了英格兰中部和南部 69 家全科诊所的参与者。年龄在 80 岁或以上、收缩压低于 150 mm Hg 且服用两种或两种以上降压药的参与者被随机分配(1:1)接受降压药减量治疗(停用一种降压药)或常规治疗。全科医生和参与者都知道随机分配后的治疗方案,但负责分析数据的人员在整个研究过程中都不知道治疗方案的分配。参与者在随机分配后至少 3 年通过其初级和中级医疗电子健康记录接受随访。主要结果是全因住院时间或死亡率。采用 Cox 回归模型进行意向治疗分析。此外,还对主要结果进行了协议分析,排除了干预组中未减少治疗或在最初试验的12周随访期间恢复用药的参与者。本研究已在欧盟药物管理局临床试验数据库(EudraCT2016-004236-38)和ISRCTN注册中心(ISRCTN97503221)注册:2017年3月20日至2018年9月30日期间,共有569名参与者被随机分配。其中,564人(99%;干预组=280人;对照组=284人)接受了中位数为4-0年(IQR为3-7-4-3)的随访。基线参与者的平均年龄为 84-8 岁(SD 3-4),273 人(48%)为女性。有 109 名参与者在随访中持续减少用药(占干预组 213 名存活参与者的 51%)。与对照组相比,干预组的参与者减少了更多的降压药(调整后的平均差异为-0-35 种药物 [95% CI -0-52至-0-18])。总体而言,干预组中有 202 人(72%)在随访期间住院或死亡,对照组中有 218 人(77%)住院或死亡(调整后危险比 [aHR] 0-93 [95% CI 0-76 to 1-12])。有证据表明,在干预组中,按协议人群中出现主要结果的参与者比例较低(aHR 0-80 [0-64 to 1-00]):半数参与者持续减少用药,没有证据表明全因住院率或死亡率上升。这些研究结果表明,对于80岁或80岁以上、血压得到控制、服用两种或两种以上降压药的人来说,降压药减量干预可能是安全的:资金来源:英国心脏基金会和国家健康与护理研究所。
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来源期刊
Lancet Healthy Longevity
Lancet Healthy Longevity GERIATRICS & GERONTOLOGY-
CiteScore
16.30
自引率
2.30%
发文量
192
审稿时长
12 weeks
期刊介绍: The Lancet Healthy Longevity, a gold open-access journal, focuses on clinically-relevant longevity and healthy aging research. It covers early-stage clinical research on aging mechanisms, epidemiological studies, and societal research on changing populations. The journal includes clinical trials across disciplines, particularly in gerontology and age-specific clinical guidelines. In line with the Lancet family tradition, it advocates for the rights of all to healthy lives, emphasizing original research likely to impact clinical practice or thinking. Clinical and policy reviews also contribute to shaping the discourse in this rapidly growing discipline.
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