在有心力衰竭病史的 2 型糖尿病患者中，噻唑烷二酮类药物累积剂量与临床结局的关系：台湾基于人群的队列研究。

Relationship between cumulative dose of thiazolidinediones and clinical outcomes in type 2 diabetic patients with history of heart failure: a population-based cohort study in Taiwan.

机构信息

Institute of Health and Welfare Policy, National Yang-Ming University, Taipei, Taiwan.

出版信息

Pharmacoepidemiol Drug Saf. 2010 Aug;19(8):786-91. doi: 10.1002/pds.1999.

DOI:10.1002/pds.1999

PMID:20607752

Abstract

BACKGROUND

Thiazolidinediones (TZDs) are widely used antidiabetic agents, but there is great concern and conflicting reports over their possible effect on cardiovascular morbidity, especially in patients with heart failure (HF).

METHODS

Using 2000-2005 Taiwan's National Health Insurance (NHI) claims data, this population-based, retrospective cohort study investigated if there was an association between the cumulative TZD dose and clinical outcomes in type 2 diabetic patients recently hospitalized for HF. Study outcomes were death, first all-cause readmission, and first readmission for HF. Cox proportional hazard models were used to analyze the association between TZD versus sulfonylurea (SU) use and these outcomes.

RESULTS

Out of a total of 8139 eligible patients, 224 were taking TZD (65.63% female; mean [SD] age, 68.30[10.60] years) and 7915 were taking SU (55.10% female; 70.30[10.50] years). Patients taking TZD were at higher risk for readmission for HF (59 cases; HR 1.58 (95% confidence interval, 95%CI 1.44-1.72)), all-cause readmission (147 cases; 1.40 (1.30-1.70)), and death (103 cases; 2.23 (1.58-3.14)). The higher the cumulative exposure to TZD, the greater the risk of HF readmission, all-cause readmission, and death.

CONCLUSION

Among diabetic patients who had been hospitalized for HF, TZD users were at significantly greater risk for readmission for HF, all-cause readmission, and death than SU users. The risk of all adverse clinical outcomes appeared to highly relate to cumulative exposure to TZD. These findings provide empirical evidence supporting the latest black box warnings issued by the United States Food and Drug Administration in August, 2007 advising that TZD not be prescribed for diabetic patients with symptomatic heart failure.

摘要

背景

噻唑烷二酮类（TZDs）是广泛应用的抗糖尿病药物，但它们对心血管发病率的可能影响存在很大的关注和相互矛盾的报告，特别是在心力衰竭（HF）患者中。

方法

利用 2000-2005 年台湾全民健康保险（NHI）理赔数据，这项基于人群的回顾性队列研究调查了在最近因 HF 住院的 2 型糖尿病患者中，累积 TZD 剂量与临床结局之间是否存在关联。研究结局为死亡、首次全因再入院和首次 HF 再入院。Cox 比例风险模型用于分析 TZD 与磺酰脲类（SU）使用与这些结局之间的关系。

结果

在总共 8139 名合格患者中，有 224 名患者服用 TZD（65.63%为女性；平均[标准差]年龄为 68.30[10.60]岁），7915 名患者服用 SU（55.10%为女性；70.30[10.50]岁）。服用 TZD 的患者 HF 再入院（59 例；风险比[HR]1.58（95%置信区间，95%CI 1.44-1.72））、全因再入院（147 例；1.40（1.30-1.70））和死亡（103 例；2.23（1.58-3.14））的风险更高。累积 TZD 暴露越高，HF 再入院、全因再入院和死亡的风险就越大。

结论

在因 HF 住院的糖尿病患者中，与 SU 使用者相比，TZD 使用者 HF 再入院、全因再入院和死亡的风险显著更高。所有不良临床结局的风险似乎与 TZD 的累积暴露高度相关。这些发现提供了支持美国食品和药物管理局（FDA）在 2007 年 8 月发布的最新黑框警告的经验证据，该警告建议对有症状心力衰竭的糖尿病患者不要开处方 TZD。