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Effects of Spironolactone and Chlorthalidone on Cardiovascular Structure and Function in Chronic Kidney Disease: A Randomized, Open-Label Trial
Clinical Journal of the American Society of Nephrology ( IF 8.5 ) Pub Date : 2021-10-01 , DOI: 10.2215/cjn.01930221
Nicola C Edwards 1, 2 , Anna M Price 1, 3 , Samir Mehta 4 , Thomas F Hiemstra 5, 6 , Amreen Kaur 1 , Peter J Greasley 7 , David J Webb 8 , Neeraj Dhaun 8, 9 , Iain M MacIntyre 8, 9 , Tariq Farrah 8, 9 , Vanessa Melville 8 , Anna S Herrey 10 , Gemma Slinn 4 , Rebekah Wale 4 , Natalie Ives 4 , David C Wheeler 11, 12 , Ian Wilkinson 5, 6 , Richard P Steeds 1, 13 , Charles J Ferro 1, 3 , Jonathan N Townend 1, 13
Affiliation  

Background and objectives

In a randomized double-blind, placebo-controlled trial, treatment with spironolactone in early-stage CKD reduced left ventricular mass and arterial stiffness compared with placebo. It is not known if these effects were due to BP reduction or specific vascular and myocardial effects of spironolactone.

Design, setting, participants, & measurements

A prospective, randomized, open-label, blinded end point study conducted in four UK centers (Birmingham, Cambridge, Edinburgh, and London) comparing spironolactone 25 mg to chlorthalidone 25 mg once daily for 40 weeks in 154 participants with nondiabetic stage 2 and 3 CKD (eGFR 30–89 ml/min per 1.73 m2). The primary end point was change in left ventricular mass on cardiac magnetic resonance imaging. Participants were on treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and had controlled BP (target ≤130/80 mm Hg).

Results

There was no significant difference in left ventricular mass regression; at week 40, the adjusted mean difference for spironolactone compared with chlorthalidone was –3.8 g (95% confidence interval, –8.1 to 0.5 g, P=0.08). Office and 24-hour ambulatory BPs fell in response to both drugs with no significant differences between treatment. Pulse wave velocity was not significantly different between groups; at week 40, the adjusted mean difference for spironolactone compared with chlorthalidone was 0.04 m/s (–0.4 m/s, 0.5 m/s, P=0.90). Hyperkalemia (defined ≥5.4 mEq/L) occurred more frequently with spironolactone (12 versus two participants, adjusted relative risk was 5.5, 95% confidence interval, 1.4 to 22.1, P=0.02), but there were no patients with severe hyperkalemia (defined ≥6.5 mEq/L). A decline in eGFR >30% occurred in eight participants treated with chlorthalidone compared with two participants with spironolactone (adjusted relative risk was 0.2, 95% confidence interval, 0.05 to 1.1, P=0.07).

Conclusions

Spironolactone was not superior to chlorthalidone in reducing left ventricular mass, BP, or arterial stiffness in nondiabetic CKD.



中文翻译:

螺内酯和氯噻酮对慢性肾脏病患者心血管结构和功能的影响:一项随机、开放标签试验

背景和目标

在一项随机双盲、安慰剂对照试验中,与安慰剂相比,螺内酯治疗早期 CKD 可降低左心室质量和动脉硬度。目前尚不清楚这些影响是由于血压降低还是螺内酯对血管和心肌的特定影响。

设计、设置、参与者和测量

在英国的四个中心(伯明翰、剑桥、爱丁堡和伦敦)进行的一项前瞻性、随机、开放标签、盲法终点研究在 154 名非糖尿病 2 期和 3 期参与者中比较了螺内酯 25 mg 和氯噻酮 25 mg,每天一次,持续 40 周CKD(eGFR 30–89 毫升/分钟/1.73 m 2)。主要终点是心脏磁共振成像左心室质量的变化。参与者正在接受血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂的治疗,并控制血压(目标≤130/80 mm Hg)。

结果

左心室质量消退无显着差异;第 40 周时,与氯噻酮相比,螺内酯的校正平均差异为 –3.8 g(95% 置信区间,–8.1 至 0.5 g,P =0.08)。办公室和 24 小时动态血压对两种药物的反应均有所下降,治疗之间没有显着差异。各组脉搏波速度无显着差异;在第 40 周,与氯噻酮相比,螺内酯的校正平均差为 0.04 m/s(–0.4 m/s,0.5 m/s,P = 0.90)。螺内酯组高钾血症(定义≥5.4 mEq/L)的发生率更高(12 名与 2 名参与者,调整后的相对风险为 5.5,95% 置信区间,1.4 至 22.1,P=0.02),但没有严重高钾血症(定义≥6.5 mEq/L)的患者。与接受螺内酯治疗的两名参与者相比,八名接受氯噻酮治疗的参与者的 eGFR 下降 >30%(调整后的相对风险为 0.2,95% 置信区间,0.05 至 1.1,P = 0.07)。

结论

螺内酯在降低非糖尿病性 CKD 患者的左心室质量、血压或动脉硬度方面并不优于氯噻酮。

更新日期:2021-10-08
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