SPRINT trial

  • 文章类型: Journal Article
    肾脏疾病的风险影响:改善老年人的全球结果(KDIGO)慢性肾脏疾病分类存在争议。我们通过估算的肾小球滤过率(eGFR)和尿白蛋白-肌酐比(UACR)类别评估了该人群的不良结局风险。
    前瞻性队列。
    总共,2,509名年龄≥75岁的参与者参加了收缩压干预试验(SPRINT)。
    KDIGOeGFR和UACR类别。我们结合了KDIGO类别G1和G2,G3b和G4,以及A2和A3。
    主要SPRINT结果(复合心肌梗死,其他急性冠脉综合征,中风,心力衰竭,或因心血管原因死亡),和全因死亡。
    多变量Cox比例风险模型。
    平均年龄为79.8岁,37.4%为女性。平均eGFR为64.0mL/min/1.73m2,中位UACR为13.1mg/g。在多变量Cox比例风险分析中,与eGFR≥60mL/min/1.73m2和UACR<30mg/g的参与者相比,eGFR为45~59或15~44mL/min/1.73m2且UACR<30mg/g的参与者的主要结局风险无统计学差异.然而,eGFR为45-59或15-44mL/min/1.73m2且UACR≥30mg/g的患者具有较高的主要结局风险(HR[95%CI],1.97[1.27-3.04]和3.32[2.23-4.93],分别)。eGFR和UACR各异常类别的全因死亡风险较高,在eGFR为15-44mL/min/1.73m2且UACR≥30mg/g(3.34[2.05-5.44])的人群中,风险最高。
    患有糖尿病和尿蛋白>1g/天的个体从SPRINT中排除。
    在老年人SPRINT参与者中,无蛋白尿的低eGFR与较高的死亡率相关,但与心血管事件风险增加无关.需要更多的研究来评估老年人适应的基于慢性肾脏疾病阶段的风险分层。
    使用SPRINT试验参与者的数据,我们在75岁以上无糖尿病的成人中评估了慢性肾脏病分期与不良临床结局的关系.我们发现,由低估计肾小球滤过率和中度或重度尿白蛋白排泄增加决定的低水平肾功能与心血管事件和全因死亡率的风险增加相关。然而,低估计肾小球滤过率和正常或轻度增加的尿白蛋白排泄与这些不良结局并不一致.这一发现支持了需要更多的研究来评估慢性肾脏疾病的年龄适应分类,以改善老年人的风险分层。
    UNASSIGNED: The risk implications of the Kidney Disease: Improving Global Outcomes (KDIGO) chronic kidney disease classification in older adults are controversial. We evaluated the risk of adverse outcomes in this population across categories of estimated glomerular filtration rate (eGFR) and urinary albumin-creatinine ratio (UACR).
    UNASSIGNED: Prospective cohort.
    UNASSIGNED: In total, 2,509 participants aged ≥75 years in the Systolic Blood Pressure Intervention Trial (SPRINT).
    UNASSIGNED: KDIGO eGFR and UACR categories. We combined KDIGO categories G1 and G2, G3b and G4, as well as A2 and A3.
    UNASSIGNED: Primary SPRINT outcome (composite of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes), and all-cause death.
    UNASSIGNED: Multivariable Cox proportional hazard models.
    UNASSIGNED: Mean age was 79.8 years, and 37.4% were female. The mean eGFR was 64.0 mL/min/1.73 m2, and the median UACR was 13.1 mg/g. In multivariable Cox proportional hazard analysis, compared with participants with eGFR ≥ 60 mL/min/1.73 m2 and UACR < 30 mg/g, there was no statistically significant difference in the risk of the primary outcome among participants with eGFR 45-59 or 15-44 mL/min/1.73 m2 and UACR < 30 mg/g. However, those with eGFR 45-59 or 15-44 mL/min/1.73 m2 and UACR ≥ 30 mg/g had higher risk of the primary outcome (HR [95% CI], 1.97 [1.27-3.04] and 3.32 [2.23-4.93], respectively). The risk for all-cause death was higher for each category of abnormal eGFR and UACR, with the highest risk observed among those with eGFR 15-44 mL/min/1.73 m2 and UACR ≥ 30 mg/g (3.34 [2.05-5.44]).
    UNASSIGNED: Individuals with diabetes and urine protein >1 g/day were excluded from SPRINT.
    UNASSIGNED: Among older adults SPRINT participants, low eGFR without albuminuria was associated with higher mortality but not with increased risk of cardiovascular events. Additional studies are needed to evaluate an adapted chronic kidney disease stage-based risk stratification for older adults.
    Using data from participants in the SPRINT trial, we evaluated the association of chronic kidney disease stage with adverse clinical outcomes among adults older than 75 years without diabetes. We found that low level of kidney function determined by a low estimated glomerular filtration rate with moderately or severely increased urine albumin excretion was associated with increased risk for cardiovascular events and all-cause mortality. However, low estimated glomerular filtration rate with normal or mildly increased urinary albumin excretion was not consistently associated with these adverse outcomes. This finding supports the need for additional studies to evaluate an age-adapted classification of chronic kidney disease to improve risk stratification among older adults.
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  • 文章类型: Journal Article
    背景:在最初的SPRINT文章中,年龄被归类为75岁,这与之前60年的许多临床试验相反。
    方法:SPRINT试验将9,361名高血压患者随机分配至<120mmHg的目标血压。<140mmHg(密集vs.标准治疗,分别)。将年龄重新分类为<60岁和≥60岁,并以95%置信区间(CI)计算结果和不良事件的风险比(HR)。
    结果:强化治疗显著降低了<60岁和≥60岁亚组的主要结局,相对风险降低(RRR)分别为36%和22%。分别,HR为0.58[95%CI,0.36-0.94]和0.78[95%CI,0.65-0.93],分别。尽管强化治疗在总体比较中对心肌梗死(MI)没有影响,在年龄<60岁的患者中,它显著降低了MI,RRR为58%,HR为0.39[95%CI,0.17-0.91].在≥60岁的亚组中,强化治疗后心力衰竭发生率降低,包括其他心血管原因导致的死亡;然而,在<60岁的亚组中未观察到这些情况.强化治疗导致明显的低血压,晕厥,急性肾功能衰竭,或≥60岁年龄组的急性肾损伤;相反,<60岁的患者发生这些不良反应的风险并未增加.
    结论:强化血压控制对老年患者(年龄≥60岁)有益,尽管不良事件的风险增加。
    In the original SPRINT article, age was categorized at 75 years, which was contrary to many previous clinical trials which is at 60 years.
    The SPRINT trial randomized 9,361 hypertensive patients to a target blood pressure of <120 vs. <140 mm Hg (intensive vs. standard treatment, respectively). Age was re-categorized as <60 and ≥60 years and hazard ratios (HRs) were calculated with 95% confidence intervals (CIs) for outcomes and adverse events.
    Intensive treatment reduced primary outcome significantly in both <60 and ≥60 years of age subgroups with a relative risk reduction (RRR) of 36% and 22%, respectively, and HR of 0.58 [95% CI, 0.36-0.94] and 0.78 [95% CI, 0.65-0.93], respectively. Although the intensive treatment rendered no effect on myocardial infarction (MI) in the overall comparison, it significantly reduced MI in patients <60 years of age with an RRR of 58% and HR of 0.39 [95% CI, 0.17-0.91]. In the ≥60-year age subgroup, reduced heart failure incidence was noted after intensive treatment, including death from other cardiovascular causes; however, these were not observed in the <60-year age subgroup. Intensive treatment resulted in significant hypotension, syncope, acute renal failure, or acute kidney injury in the ≥60-year age group; conversely, the risk of these adverse effects in patients <60 years of age did not increase.
    Intensive blood pressure control is beneficial for elderly patients (age ≥60 years), albeit with increased risk of adverse events.
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  • 文章类型: Journal Article
    未经证实:已经在糖尿病患者中研究了与非蛋白尿慢性肾病(CKD)相关的风险,但在高血压患者中没有。这项研究的目的是调查收缩压干预试验(SPRINT)人群中治疗的高血压患者与非白蛋白CKD相关的风险。
    UASSIGNED:基于基线白蛋白尿状态(尿白蛋白/肌酐比值[UACR],≥30或<30mg/g)和估计的肾小球滤过率水平([eGFR],≥60、45-59或<45mL/min/1.73m2),参与者被分为6个亚组,以评估与主要结局和死亡率相关的风险.主要的复合结局是心肌梗死,其他急性冠脉综合征,中风,心力衰竭,或心血管原因导致的死亡。
    UNASSIGNED:在8,866名高血压患者中,中位随访时间为3.26年,主要结局为352例死亡和547例参与者.在使用非CKD和非蛋白尿(eGFR≥60mL/min/1.73m2结合UACR<30mg/g)作为参考的校正Cox回归分析中,蛋白尿是否合并CKD,在总人口中,主要结局和全因死亡率的风险均显着升高。然而,在强化治疗组中,非蛋白尿合并eGFR<45mL/min/1.73m2的主要结局和全因死亡率的风险均显著增高.
    UNASSIGNED:只有当eGFR<45mL/min/1.73m2时,非白蛋白型CKD才有更高的全因死亡和CVD死亡风险。无论eGFR水平如何,蛋白尿增加都会导致主要结局和全因死亡率的风险更高。
    未经评估:ClinicalTrials.gov,编号:NCT01206062。
    UNASSIGNED: The risks associated with non-albuminuric chronic kidney disease (CKD) have been investigated in diabetes mellitus but not in hypertensive patients. The objective of this study was to investigate the risks associated with non-albuminuric CKD in treated hypertensive patients in the Systolic Blood Pressure Intervention Trial (SPRINT) population.
    UNASSIGNED: Based on baseline albuminuria status (urine albumin/creatinine ratio [UACR], ≥30 or <30 mg/g) and the levels of estimated glomerular filtration rate ([eGFR], ≥60, 45-59, or <45 mL/min/1.73 m2), participants were classified into six subgroups to assess the risks associated with the primary outcome and mortality. The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or mortality from cardiovascular causes.
    UNASSIGNED: During a median follow-up of 3.26 years in 8,866 hypertensive patients, there were 352 deaths and 547 participants with the primary outcome. In adjusted Cox regression analysis using non-CKD and non-albuminuria (eGFR ≥60 mL/min/1.73 m2 combined with UACR <30 mg/g) as reference, albuminuria whether combined with CKD or not, showed significantly higher risk of both primary outcome and all-cause mortality in the total population. Whereas, non-albuminuria only combined with eGFR <45 mL/min/1.73 m2 showed significantly higher risk of both primary outcome and all-cause mortality in the intensive-therapy group.
    UNASSIGNED: Non-albuminuric CKD did have higher risk of all-cause and CVD mortality only if the eGFR <45 mL/min/1.73 m2. Increased albuminuria conferred higher risk of primary outcome and all-cause mortality irrespective the levels of eGFR.
    UNASSIGNED: ClinicalTrials.gov, number: NCT01206062.
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  • 文章类型: Journal Article
    背景:指南建议加强血压控制。随机试验集中在收缩压(SBP)降低的相关性,舒张压(DBP)降低的安全性尚未解决。有数据表明,低DBP不应该阻止临床医生实现SBP目标;然而,注册和随机试验分析的结果相互矛盾.这项研究的目的是应用机器学习(ML)算法来确定,DBP是否是预测卒中的重要危险因素,心力衰竭(HF),心肌梗死(MI),和SPRINT试验数据库中的主要结局。方法:使用决策树进行ML实验,随机森林,k-最近邻,天真的贝叶斯,多层感知器,和逻辑回归算法,在未选择和选择的(DBP&lt;70mmHg)研究人群中,包括并排除DBP作为危险因素。结果:包括DBP作为风险因素并没有改变使用准确性评估的机器学习模型的性能,AUC,意思是,和加权F度量,并且不需要对中风做出适当的预测,MI,HF,和主要结果。结论:使用ML算法对SPRINT试验数据进行分析表明,在加强血压控制时,不应将DBP视为独立的危险因素。
    Background: The guidelines recommend intensive blood pressure control. Randomized trials have focused on the relevance of the systolic blood pressure (SBP) lowering, leaving the safety of the diastolic blood pressure (DBP) reduction unresolved. There are data available which show that low DBP should not stop clinicians from achieving SBP targets; however, registries and analyses of randomized trials present conflicting results. The purpose of the study was to apply machine learning (ML) algorithms to determine, whether DBP is an important risk factor to predict stroke, heart failure (HF), myocardial infarction (MI), and primary outcome in the SPRINT trial database. Methods: ML experiments were performed using decision tree, random forest, k-nearest neighbor, naive Bayesian, multi-layer perceptron, and logistic regression algorithms, including and excluding DBP as the risk factor in an unselected and selected (DBP < 70 mmHg) study population. Results: Including DBP as the risk factor did not change the performance of the machine learning models evaluated using accuracy, AUC, mean, and weighted F-measure, and was not required to make proper predictions of stroke, MI, HF, and primary outcome. Conclusions: Analyses of the SPRINT trial data using ML algorithms imply that DBP should not be treated as an independent risk factor when intensifying blood pressure control.
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  • 文章类型: Journal Article
    尽管高血压在老年人中非常普遍,治疗目标需要了解各种可用的指导方针,以及对独特医学的欣赏,认知,社会心理,和我们的个别老年患者的功能异质性,可能将他们置于这些指南之外。随着患者的临床状态随着时间的推移而变化,当他们的风险开始超过他们的益处时,临床医生可能会考虑停用血压药物。独特的临床环境和纳入高血压控制的获益时间有助于指导临床决策。
    Although hypertension is highly prevalent in older adults, treatment goals require both an understanding of the various guidelines available, as well as appreciation of the unique medical, cognitive, psychosocial, and functional heterogeneity of our individual geriatric patients that may place them outside those guidelines. As a patient\'s clinical status changes over time, clinicians may consider deprescribing their blood pressure medications when their risks begin to outweigh their benefits. Unique clinical circumstances and incorporating the time to benefit of hypertension control help guide clinical decision-making.
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  • 文章类型: Journal Article
    OBJECTIVE: To determine the cost-effectiveness of intensive blood pressure (BP) treatment in patients at high risk for cardiovascular disease (CVD) over their lifetime in Saudi Arabia.
    METHODS: A Markov model was developed for the BP strategies to estimate the added lifetime costs and quality-adjusted life-years (QALYs) gained. These 2 items were then used to develop an incremental cost-effectiveness ratio (ICER). Event rates were estimated from the Systolic Blood Pressure Intervention Trial, and the other model inputs were retrieved from previous studies. Estimated costs were collected from 5 private hospitals in Riyadh, Saudi Arabia. The model used a lifetime framework adopting healthcare payer in Saudi Arabia. Sensitivity analysis was conducted using 1-way and probabilistic sensitivity analysis to evaluate the robustness and uncertainty of the estimates.
    RESULTS: Over a 30-year period, intensive BP therapy would be cost-effective compared with the standard treatment with incremental costs per QALY, in US dollars, of $24 056. Probabilistic sensitivity analysis suggested intensive BP treatment would be cost-effective compared with standard treatment 86.7% of the time at a willingness-to-pay threshold of $$60 000 per QALY.
    CONCLUSIONS: The result of this study showed that intensive BP treatment appears to be a cost-effective choice for patients with a high risk of CVD in Saudi Arabia when compared with standard treatment.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
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  • 文章类型: Comparative Study
    BACKGROUND: The Systolic Blood Pressure Intervention Trial-CKD substudy (SPRINT-CKD) has suggested a lower blood pressure (BP) target in CKD patients. However, it is questionable whether the SPRINT-CKD results may be generalized to CKD patients under nephrology care.
    METHODS: To compare SPRINT-CKD cohort versus referred CKD patients in terms of patients\' risk profile and outcomes, we pooled four prospective cohorts of consecutive CKD patients referred to 40 Italian renal clinics. We implemented the same inclusion/exclusion criteria adopted in SPRINT and same endpoints: (1) a composite of fatal and non-fatal cardiovascular (CV) events (2) all-cause mortality and (3) ESRD (composite of chronic dialysis, transplantation or 50% eGFR decline). Findings were compared with those attained in the control arm of SPRINT-CKD trial that mirrored standard BP management in clinical practice.
    RESULTS: Out of 2847 patients referred to renal clinics, only 20.1% (n = 571) were identified as eligible for SPRINT-CKD. Age (72 ± 9 years), gender (42.2% female) and systolic BP (142 ± 10 mmHg) did not differ from the SPRINT-CKD while referred patients had a worse risk profile at baseline: larger prevalence of prior CV disease (25.7% versus 19.5%), higher Framingham risk score (31.9 ± 14.6% versus 27.2 ± 24.7%) and lower GFR (38 ± 11 versus 48 ± 10 mL/min/1.73 m2). During 4.0 years of follow-up, 86 CV events (50 fatal), 78 all-cause death and 59 ESRD occurred with annual incidence rates higher than those observed in the SPRINT-CKD control group (CV events 4.18 vs 3.19; all-cause death 3.64 vs 2.21; ESRD 2.80 vs 0.41%/year).
    CONCLUSIONS: The SPRINT-CKD cohort is poorly representative of the CKD population under nephrology care, thus suggesting that conclusions may not apply to patients referred to nephrologist.
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  • 文章类型: Journal Article
    The Systolic Blood Pressure Intervention Trial demonstrated significant decreases in cardiovascular events and total mortality with intensive systolic blood pressure lowering in adults with high cardiovascular risk in the absence of diabetes but benefits were accompanied by increased risk of adverse events.
    Over 100,000 deaths and 46,000 cases of heart failure may be prevented annually if intensive systolic blood pressure lowering is implemented in 17 million US adults who are age 50 years and older, and have high cardiovascular risk in the absence of diabetes and meet eligibility for the Systolic Blood Pressure Intervention Trial. However, the benefits of intensive SBP lowering will be accompanied by an excess of 43,000 cases of electrolyte abnormalities and 88,000 cases of acute kidney injury. Physicians should consider implementation of intensive systolic blood pressure lowering in appropriate patients who understand the risks and benefits of this intervention.
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