糖尿病肾病中的血压控制：FANTASTIC试验的事后分析
Blood pressure control in diabetic kidney disease: a post-hoc analysis of the FANTASTIC trial.
作者信息
Park Cheol Ho, Hong Soon Jun, Kim Sung Gyun, Shin Seok Joon, Kim Dong Ki, Lee Jung Pyo, Han Sang Youb, Lee Sangho, Won Jong Chul, Kang Young Sun, Park Jongha, Han Byoung-Geun, Na Ki-Ryang, Hur Kyu Yeon, Kim Yong-Jin, Park Sungha, Yoo Tae-Hyun
机构信息
Department of Internal Medicine, Institute of Kidney Disease Research, Yonsei University College of Medicine, Seoul, Republic of Korea.
Department of Cardiology, Korea University Anam Hospital, Seoul, Republic of Korea.
出版信息
Clin Hypertens. 2024 Aug 1;30(1):20. doi: 10.1186/s40885-024-00280-x.
BACKGROUND
The target blood pressure (BP) value is unclear for diabetic kidney disease (DKD). Therefore, we aimed to evaluate the effect of strict BP control or 'on treatment' BP on clinical outcomes in patients with DKD.
METHODS
A post-hoc analysis of the prespecified secondary outcomes of the FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC) trial, a randomized multicenter double-blind phase III trial. Eligible patients were aged ≥ 19 years with DKD. We assigned 341 participants with DKD to BP control strategy (standard-systolic BP [SBP] < 140 mmHg versus strict-SBP < 130 mmHg). The outcome was the occurrence of cardiovascular events and renal events. Separate analyses were performed to compared the risk of outcome according to achieved average BP levels.
RESULTS
A total of 341 participants were included in the analysis. Over a median follow-up of 2.8 years, cardiovascular/renal events were observed in 25 (7.3%) participants. Mean (SD) SBPs in the standard and strict BP control group were 140.2 (11.6) and 140.2 (11.9) mmHg, respectively. The strict BP control group did not show significantly reduced risk of cardiovascular/renal events (HR 1.32; 95% CI 0.60-2.92]). In the post-hoc analyses using achieved BP, achieved average SBP of 130-139 mmHg resulted in reduced risk of cardiovascular/renal events (HR 0.15; 95% CI 0.03-0.67) compared to achieved average SBP ≥ 140 mmHg, whereas further reduction in achieved average SBP < 130 mmHg did not impart additional benefits.
CONCLUSION
In patients with DKD, targeting a SBP of less than 130 mmHg, as compared with less than 140 mmHg, did not reduce the rate of a composite of cardiovascular and renal events. Achieved SBP of 130-139 mmHg was associated with a decreased risk for the primary outcome in patients with DKD.
TRIAL REGISTRATION
ClinicalTirals.gov Identifier: NCT02620306, registered December 3, 2015. ( https://clinicaltrials.gov/study/NCT02620306 ).
背景
糖尿病肾病（DKD）的目标血压值尚不明确。因此，我们旨在评估严格血压控制或“治疗中”血压对DKD患者临床结局的影响。
方法
对糖尿病慢性肾病中阿替沙坦与氯沙坦相比蛋白尿持续减少（FANTASTIC）试验预设的次要结局进行事后分析，这是一项随机多中心双盲III期试验。符合条件的患者年龄≥19岁且患有DKD。我们将341例DKD参与者分配至血压控制策略组（标准收缩压[SBP]<140 mmHg与严格SBP<130 mmHg）。结局为心血管事件和肾脏事件的发生情况。根据达到的平均血压水平进行单独分析以比较结局风险。
结果
共有341例参与者纳入分析。在中位随访2.8年期间，25例（7.3%）参与者发生心血管/肾脏事件。标准血压控制组和严格血压控制组的平均（标准差）SBP分别为140.2（11.6）和140.2（11.9）mmHg。严格血压控制组未显示心血管/肾脏事件风险显著降低（风险比1.32；95%置信区间0.60 - 2.92）。在使用达到的血压进行的事后分析中，与达到的平均SBP≥140 mmHg相比，达到的平均SBP为130 - 139 mmHg可降低心血管/肾脏事件风险（风险比0.15；95%置信区间0.03 - 0.67），而达到的平均SBP进一步降低至<130 mmHg并未带来额外益处。
结论
在DKD患者中，将SBP目标设定为低于130 mmHg与低于140 mmHg相比，并未降低心血管和肾脏事件复合终点的发生率。DKD患者达到的SBP为130 - 139 mmHg与主要结局风险降低相关。
试验注册
ClinicalTrials.gov标识符：NCT02620306，于2015年12月3日注册。（https://clinicaltrials.gov/study/NCT02620306）
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