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糖尿病和糖尿病前期对慢性心力衰竭患者生存结局的预后影响:GISSI-HF(意大利心力衰竭生存研究组)试验的事后分析。

Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial.

机构信息

Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

Division of Cardiology, Istituti Clinici Scientifici Maugeri, IRCCS, Veruno, Italy.

出版信息

J Am Heart Assoc. 2017 Jul 5;6(7):e005156. doi: 10.1161/JAHA.116.005156.

Abstract

BACKGROUND

The independent prognostic impact of diabetes mellitus (DM) and prediabetes mellitus (pre-DM) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre-DM on survival outcomes in the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) trial.

METHODS AND RESULTS

We assessed the risk of all-cause death and the composite of all-cause death or cardiovascular hospitalization over a median follow-up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI-HF trial, who were stratified by presence of DM (n=2852), pre-DM (n=2013), and non-DM (n=2070) at baseline. Compared with non-DM patients, those with DM had remarkably higher incidence rates of all-cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non-DM patients and those with pre-DM. Cox regression analysis showed that DM, but not pre-DM, was associated with an increased risk of all-cause death (adjusted hazard ratio, 1.43; 95% CI, 1.28-1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI, 1.13-1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all-cause death: adjusted hazard ratio, 1.21; 95% CI, 1.02-1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI, 1.01-1.29, respectively).

CONCLUSIONS

Presence of DM was independently associated with poor long-term survival outcomes in patients with chronic heart failure.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00336336.

摘要

背景

糖尿病(DM)和糖尿病前期(pre-DM)对慢性心力衰竭患者生存结局的独立预后影响已在观察性登记研究和随机临床试验中进行了研究,但结果往往不一致或相互矛盾。我们在 GISSI-HF(意大利心力衰竭生存研究组)试验中检查了 DM 和 pre-DM 对生存结局的独立预后影响。

方法和结果

我们评估了 6935 名 GISSI-HF 试验慢性心力衰竭参与者在中位数为 3.9 年的随访期间全因死亡的风险和全因死亡或心血管住院的复合终点,这些参与者在基线时按 DM(n=2852)、pre-DM(n=2013)和非 DM(n=2070)进行分层。与非 DM 患者相比,DM 患者的全因死亡率(34.5%对 24.6%)和复合终点发生率(63.6%对 54.7%)显著更高。相反,非 DM 患者和 pre-DM 患者的这两个事件发生率相似。Cox 回归分析表明,DM 与全因死亡风险增加相关(调整后的危险比,1.43;95%CI,1.28-1.60)和复合终点(调整后的危险比,1.23;95%CI,1.13-1.32),而与既定危险因素无关。在 DM 亚组中,较高的血红蛋白 A1c 也与两个研究结果的风险增加独立相关(全因死亡:调整后的危险比,1.21;95%CI,1.02-1.43;复合终点:调整后的危险比,1.14;95%CI,1.01-1.29)。

结论

DM 的存在与慢性心力衰竭患者的长期预后不良独立相关。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00336336。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19cc/5586270/3e9f4c9b65b8/JAH3-6-e005156-g001.jpg

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