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培哚普利吲达帕胺复方制剂治疗 2 型糖尿病合并慢性肾脏病患者的疗效。

Effects of a fixed combination of perindopril and indapamide in patients with type 2 diabetes and chronic kidney disease.

机构信息

The George Institute for International Health, University of Sydney, Missenden Road, Camperdown, Sydney, NSW 2050, Australia.

出版信息

Eur Heart J. 2010 Dec;31(23):2888-96. doi: 10.1093/eurheartj/ehq139. Epub 2010 May 25.

DOI:10.1093/eurheartj/ehq139
PMID:20501479
Abstract

AIMS

Individuals with diabetes and chronic kidney disease (CKD) are at high risk for cardiovascular disease. In these analyses of the ADVANCE trial, we assessed the effects of a fixed combination of perindopril-indapamide on renal and cardiovascular outcomes in patients with type 2 diabetes according to baseline CKD stage.

METHODS AND RESULTS

Patients with type 2 diabetes were randomized to perindopril-indapamide (4 mg/1.25 mg) or placebo. Treatment effects on cardiovascular (cardiovascular death, myocardial infarction, or stroke) and renal outcomes were compared in subgroups defined by baseline Kidney Disease Outcome Quality Initiative CKD stage. Homogeneity in treatment effect was tested by adding interaction terms to the relevant Cox models. The study included 10 640 participants with known CKD status, of whom 6125 did not have CKD, 2482 were classified as CKD stage 1 or 2, and 2033 as CKD stage ≥3. The relative treatment effects on major cardiovascular events were similar across all stages of CKD, with no heterogeneity in the magnitude of the effects for any outcome. In contrast, the absolute treatment effects approximately doubled in those with CKD stage ≥3 when compared to those with no CKD. For every 1000 patients with CKD stage ≥3 treated for 5 years, active treatment prevented 12 cardiovascular events when compared with six events per 1000 patients with no CKD.

CONCLUSION

The treatment benefits of a routine administration of a fixed combination of perindopril-indapamide to patients with type 2 diabetes on cardiovascular and renal outcomes, and death, are consistent across all stages of CKD at baseline. Absolute risk reductions are larger in patients with CKD highlighting the importance of blood pressure-lowering in this population.

摘要

目的

患有糖尿病和慢性肾脏病(CKD)的个体患心血管疾病的风险很高。在 ADVANCE 试验的这些分析中,我们评估了培哚普利吲达帕胺固定复方制剂对 2 型糖尿病患者根据基线 CKD 分期的肾脏和心血管结局的影响。

方法和结果

将 2 型糖尿病患者随机分为培哚普利吲达帕胺(4mg/1.25mg)或安慰剂组。根据基线肾脏病预后质量倡议(KDIGO)CKD 分期,在亚组中比较心血管(心血管死亡、心肌梗死或中风)和肾脏结局的治疗效果。通过向相关 Cox 模型添加交互项来检验治疗效果的同质性。该研究纳入了 10640 名已知 CKD 状态的参与者,其中 6125 名没有 CKD,2482 名被归类为 CKD 1 或 2 期,2033 名 CKD 期≥3 期。在 CKD 的所有阶段,主要心血管事件的相对治疗效果相似,任何结局的效果大小均无异质性。相比之下,与无 CKD 的患者相比,在 CKD 期≥3 的患者中,绝对治疗效果大约增加了一倍。对于每 1000 名 CKD 期≥3 期的患者,接受 5 年治疗,与无 CKD 的患者每 1000 名患者发生 6 次事件相比,积极治疗可预防 12 次心血管事件。

结论

在基线 CKD 的所有阶段,常规给予培哚普利吲达帕胺固定复方制剂治疗 2 型糖尿病患者,可带来心血管和肾脏结局以及死亡的治疗益处。在 CKD 患者中,绝对风险降低幅度更大,突出了在该人群中降压的重要性。

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