高血压患者早上或晚上服用常规降压药对心血管结局的影响无差异
2022-10-15   阅读:746   来源:柳叶刀

英国邓迪大学Thomas M MacDonald团队比较了英国成年高血压患者早晚服用常规降压药对心血管的影响。相关论文发表在2022年10月11日出版的《柳叶刀》杂志上。

研究表明,晚上服用抗高血压药物可能比早上服用效果更好。晨间与晚间治疗(TIME)研究旨在调查晚间服用常规抗高血压药物与早间服用相比是否能改善高血压患者的重大心血管结局。

TIME研究是一项前瞻性、务实、分散、在英国进行的平行小组研究,招募成年参与者(≥18岁),并至少服用一种抗高血压药物。符合条件的参与者被随机分配(1:1),不受限制、分层或最小化,在早上(06:00-10:00)或晚上(20:00-00:00)服用所有常规抗高血压药物。对受试者进行随访,以确定血管死亡或非致命性心肌梗死或非致命中风住院的复合主要终点。

终点通过参与者报告或与国家卫生服务数据集关联的记录来确定,并由一个不知晓治疗分配的委员会进行评定。主要终点为意向治疗人群(即随机分配到治疗组的所有参与者)中首次发生事件的时间。对至少提交一份随访问卷的所有参与者进行安全性评估。

2011年12月17日至2018年6月5日,共有24610人接受了筛查,21104人被随机分配,其中晚上给药组10503例,早上给药组10601例。参与者入组时的平均年龄为65.1岁;12136名(57.5%)为男性;女性8968名(42.5%);19101名(90.5%)为白人;98名(0.5%)为黑人、非洲人、加勒比海人或英国黑人;1637名(7.8%)未报告族裔;2725名(13.0%)既往有心血管疾病。

在研究随访结束时(2021年3月31日),中位随访时间为5.2年,其中10503名被分配到晚间治疗的参与者中有529名(5.0%)退出了所有随访,10601名被分配到早间治疗的参与者中有318名(3.0%)。接受晚间治疗的参与者中有362(3.4%)名发生主要终点事件(每100患者-年发生0.69次事件),接受早间治疗的患者中有390(3.7%)名(每100患者-年发生0.72次事件),未经校正的危险比为0.95。未发现任何安全问题。

研究结果表明,在重大心血管结局方面,夜间服用常规抗高血压药物与早晨服用药物并无差异。可以建议患者在方便的时候定期服用抗高血压药物,以尽量减少任何不良反应。

附:英文原文

Title: Cardiovascular outcomes in adults with hypertension with evening versus morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial

Author: Isla S Mackenzie, Amy Rogers, Neil R Poulter, Bryan Williams, Morris J Brown, David J Webb, Ian Ford, David A Rorie, Greg Guthrie, J W Kerr Grieve, Filippo Pigazzani, Peter M Rothwell, Robin Young, Alex McConnachie, Allan D Struthers, Chim C Lang, Thomas M MacDonald

Issue&Volume: 2022-10-11

Abstract:

Background

Studies have suggested that evening dosing with antihypertensive therapy might have better outcomes than morning dosing. The Treatment in Morning versus Evening (TIME) study aimed to investigate whether evening dosing of usual antihypertensive medication improves major cardiovascular outcomes compared with morning dosing in patients with hypertension.

Methods

The TIME study is a prospective, pragmatic, decentralised, parallel-group study in the UK, that recruited adults (aged ≥18 years) with hypertension and taking at least one antihypertensive medication. Eligible participants were randomly assigned (1:1), without restriction, stratification, or minimisation, to take all of their usual antihypertensive medications in either the morning (0600–1000 h) or in the evening (2000–0000 h). Participants were followed up for the composite primary endpoint of vascular death or hospitalisation for non-fatal myocardial infarction or non-fatal stroke. Endpoints were identified by participant report or record linkage to National Health Service datasets and were adjudicated by a committee masked to treatment allocation. The primary endpoint was assessed as the time to first occurrence of an event in the intention-to-treat population (ie, all participants randomly assigned to a treatment group). Safety was assessed in all participants who submitted at least one follow-up questionnaire. The study is registered with EudraCT (2011-001968-21) and ISRCTN (18157641), and is now complete.

Findings

Between Dec 17, 2011, and June 5, 2018, 24610 individuals were screened and 21104 were randomly assigned to evening (n=10503) or morning (n=10601) dosing groups. Mean age at study entry was 65·1 years (SD 9·3); 12136 (57·5%) participants were men; 8968 (42·5%) were women; 19101 (90·5%) were White; 98 (0·5%) were Black, African, Caribbean, or Black British (ethnicity was not reported by 1637 [7·8%] participants); and 2725 (13·0%) had a previous cardiovascular disease. By the end of study follow-up (March 31, 2021), median follow-up was 5·2 years (IQR 4·9–5·7), and 529 (5·0%) of 10503 participants assigned to evening treatment and 318 (3·0%) of 10601 assigned to morning treatment had withdrawn from all follow-up. A primary endpoint event occurred in 362 (3·4%) participants assigned to evening treatment (0·69 events [95% CI 0·62–0·76] per 100 patient-years) and 390 (3·7%) assigned to morning treatment (0·72 events [95% CI 0·65–0·79] per 100 patient-years; unadjusted hazard ratio 0·95 [95% CI 0·83–1·10]; p=0·53). No safety concerns were identified.

Interpretation

Evening dosing of usual antihypertensive medication was not different from morning dosing in terms of major cardiovascular outcomes. Patients can be advised that they can take their regular antihypertensive medications at a convenient time that minimises any undesirable effects.

DOI: 10.1016/S0140-6736(22)01786-X

编辑:小柯机器人

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