Association of Low-Dose Triple Combination Therapy vs Usual Care With Time at Target Blood Pressure: A Secondary Analysis of the TRIUMPH Randomized Clinical Trial.
Association of Low-Dose Triple Combination Therapy vs Usual Care With Time at Target Blood Pressure: A Secondary Analysis of the TRIUMPH Randomized Clinical Trial.
复制标题
低剂量三联疗法与常规护理与目标血压时间的关系：TRIUMPH 随机临床试验的二次分析。
DOI：
10.1001/jamacardio.2022.0471
复制
发表时间：
2022
期刊：
影响因子：
24
通讯作者：
A. Rodgers
中科院分区：
文献类型：
--
作者：
S. Gnanenthiran;Nelson Wang;G. D. Di Tanna;A. Salam;R. Webster;H. D. de Silva;Rama Krishna Guggilla;Stephen Jan;P. Maulik;N. Naik;V. Selak;S. Thom;D. Prabhakaran;A. Schutte;Anushka Patel;A. Rodgers
重要性
累积暴露于高血压（BP）是一个不良预后标志。血压随时间控制的评估，例如达到目标的时间，已经制定出来，但缺乏对降压干预措施对这些措施的影响的评估。
目的
评估低剂量三联抗高血压治疗与常规治疗相比是否与更高的达标时间相关。
设计、设置和参与者
针对轻度至中度高血压患者的三联药丸与常规护理管理 (TRIUMPH) 试验是一项低剂量三联血压治疗与常规护理的开放标签随机临床试验，于 2016 年 2 月至 2017 年 5 月在斯里兰卡城市医院诊所进行。包括收缩压>130毫米汞柱和/或舒张压>80毫米汞柱）需要开始（未经治疗的患者）或升级（接受单一治疗的患者）抗高血压治疗。如果患者目前正在服用两种或多种降血压药物，或者患有严重或无法控制的血压、加速高血压或医生确定需要减慢滴定治疗、三联药治疗的禁忌症、不稳定的医疗状况或研究人员认为不适合本研究的具有临床意义的实验室值，则患者被排除。原始试验中的全部 700 人均纳入二次分析。这项事后分析是在 2020 年 12 月至 2021 年 12 月期间进行的。
干预
每日一次固定剂量三联药（替米沙坦 20 毫克、氨氯地平 2.5 毫克和氯噻酮 12.5 毫克）治疗与常规治疗对比。
主要成果和措施
在 24 周的随访期间比较组间达到目标时间的差异，达到目标时间定义为达到目标血压的时间百分比。
结果
共有 700 名随机患者（平均 [SD] 年龄，56 [11] 岁；403 名 [57.6%] 女性）。在 24 周的随访中，分配到三联药组的患者 (n = 349) 与常规护理组 (n = 351) 的患者相比，达到目标的时间更长 (64% vs 43%；风险差异，21%；95% CI，16-26；P < .001)。在随访期间，接受三联药物治疗的患者达到目标时间超过 50% 的患者数量几乎是两倍（64% vs 37%；P < .001）。三联药丸与延长达到目标时间的关联很早就被发现，大多数患者在 12 周时达到目标时间超过 50%。与接受常规护理的患者相比，接受三联药丸的患者在所有随访期间达到目标的时间始终较高（平均 [SD]：0-6 周，36.3% [30.9%] vs 21.7% [28.9%]；P < .001；6-12 周，5.2% [31.9%] vs 33.7% [33.0%]； P < .001；12-24 周，66.0% [31.1%] vs 43.5% [34.3%]；P < .001）。
结论和相关性
据我们所知，该分析首次估计了目标时间，作为随机临床试验中评估纵向血压控制的结果。在轻度至中度高血压患者中，与常规治疗相比，低剂量三联药治疗与达到目标的时间显着延长相关。
Importance
Cumulative exposure to high blood pressure (BP) is an adverse prognostic marker. Assessments of BP control over time, such as time at target, have been developed but assessments of the effects of BP-lowering interventions on such measures are lacking.
Objective
To evaluate whether low-dose triple combination antihypertensive therapy was associated with greater rates of time at target compared with usual care.
Design, Setting, and Participants
The Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension (TRIUMPH) trial was a open-label randomized clinical trial of low-dose triple BP therapy vs usual care conducted in urban hospital clinics in Sri Lanka from February 2016 to May 2017. Adults with hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg or in patients with diabetes or chronic kidney disease, systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy were included. Patients were excluded if they were currently taking 2 or more blood pressure-lowering drugs or had severe or uncontrolled blood pressure, accelerated hypertension or physician-determined need for slower titration of treatment, a contraindication to the triple combination pill therapy, an unstable medical condition, or clinically significant laboratory values deemed by researchers to be unsuitable for the study. All 700 individuals in the original trial were included in the secondary analysis. This post hoc analysis was conducted from December 2020 to December 2021.
Intervention
Once-daily fixed-dose triple combination pill (telmisartan 20 mg, amlodipine 2.5 mg, and chlorthalidone 12.5 mg) therapy vs usual care.
Main Outcomes and Measures
Between-group differences in time at target were compared over 24 weeks of follow-up, with time at target defined as percentage of time at target BP.
Results
There were a total of 700 randomized patients (mean [SD] age, 56 [11] years; 403 [57.6%] women). Patients allocated to the triple pill group (n = 349) had higher time at target compared with those in the usual care group (n = 351) over 24 weeks' follow-up (64% vs 43%; risk difference, 21%; 95% CI, 16-26; P < .001). Almost twice as many patients receiving triple pill therapy achieved more than 50% time at target during follow-up (64% vs 37%; P < .001). The association of the triple pill with an increase in time at target was seen early, with most patients achieving more than 50% time at target by 12 weeks. Those receiving the triple pill achieved a consistently higher time at target at all follow-up periods compared with those receiving usual care (mean [SD]: 0-6 weeks, 36.3% [30.9%] vs 21.7% [28.9%]; P < .001; 6-12 weeks, 5.2% [31.9%] vs 33.7% [33.0%]; P < .001; 12-24 weeks, 66.0% [31.1%] vs 43.5% [34.3%]; P < .001).
Conclusions and Relevance
To our knowledge, this analysis provides the first estimate of time at target as an outcome assessing longitudinal BP control in a randomized clinical trial. Among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill was associated with substantially higher time at target compared with usual care.
影响因子：
24
作者：
Fatani N;Dixon DL;Van Tassell BW;Fanikos J;Buckley LF
通讯作者：
Buckley LF