Yang Jiao, Vallarino Carlos, Bron Morgan, Perez Alfonso, Liang Huifang, Joseph Guiandre, Yu Shawn
Takeda Development Center Americas Inc. , Deerfield, IL , USA.
Curr Med Res Opin. 2014 Nov;30(11):2223-31. doi: 10.1185/03007995.2014.941054. Epub 2014 Jul 16.
The objectives of this study were to assess and compare all-cause mortality rates between pioglitazone (PIO) and insulin (INS).
The study population included 56,536 patients with type 2 diabetes aged ≥45 years who were first-time users of PIO or INS. Data from 1 May 2000 until 30 June 2010 from the i3 InVision Data Mart database were linked to death records of the US Social Security Administration obtained in March 2012, with approval from the Institutional Review Board and in full compliance with the Health Insurance Portability and Accountability Act of 1996.
Kaplan-Meier curves were generated and hazard ratios (HRs) were estimated for the occurrence of deaths in the PIO and INS cohorts using Cox proportional hazards models adjusted with inverse probability weights derived from propensity scores.
After adjustment for >40 covariates through inverse probability weights derived from propensity scores, the PIO group showed a significantly lower risk of all-cause mortality (HR 0.33; 95% confidence interval, 0.31, 0.36). The risk of all-cause mortality was also significantly lower in the PIO cohort than the INS cohort among subgroups based on baseline variables such as sex, age (<55 years, ≥55 years), antidiabetic medication use (sulfonylureas or metformin), lipid-altering medication use, and congestive heart failure status. The study has some limitations. Use of a claims database means a potential bias toward a younger cohort. Disease-specific mortality was not identified because of no recorded cause of death. Reliable information regarding the differences in disease deterioration rate and some clinical and lab results were not available, which limits the statistical adjustment of baseline variables.
PIO was associated with a lower risk of all-cause mortality than INS.
本研究的目的是评估和比较吡格列酮（PIO）与胰岛素（INS）之间的全因死亡率。
研究人群包括56536例年龄≥45岁的2型糖尿病患者，他们是PIO或INS的首次使用者。2000年5月1日至2010年6月30日来自i3 InVision数据集市数据库的数据与2012年3月获得的美国社会保障管理局的死亡记录相链接，该研究获得了机构审查委员会的批准，并完全符合1996年的《健康保险流通与责任法案》。
使用Cox比例风险模型生成Kaplan-Meier曲线，并估计PIO和INS队列中死亡发生的风险比（HRs），该模型用倾向得分得出的逆概率权重进行调整。
通过倾向得分得出的逆概率权重对40多个协变量进行调整后，PIO组显示出全因死亡率显著较低（HR 0.33；95%置信区间，0.31，0.36）。基于性别、年龄（<55岁，≥55岁）、抗糖尿病药物使用（磺脲类或二甲双胍）、调脂药物使用和充血性心力衰竭状态等基线变量的亚组中，PIO队列的全因死亡率风险也显著低于INS队列。本研究有一些局限性。使用索赔数据库意味着可能偏向年轻队列。由于没有记录死亡原因，未确定疾病特异性死亡率。关于疾病恶化率差异以及一些临床和实验室结果的可靠信息不可用，这限制了基线变量的统计调整。
与INS相比，PIO与较低的全因死亡率风险相关。
