Sara J. Cromer, Helen Tesfaye PharmD, MSc, Deborah J. Wexler MD, MSc, Ariel Freedman BS, Christina M. Shay PhD, Julie M. Paik MD, ScD, MPH, Elisabetta Patorno MD, DrPH
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We estimated rate differences (RD) and hazard ratios (HR) with 95% confidence interval (CI) and assessed effect heterogeneity.</div></div><div><h3>Results</h3><div>After matching, empagliflozin was associated with decreased risk of MACE (HR [95% CI]=0.77 [0.72, 0.81]; RD= -10.10 [-12.38, -7.83]), HHF (HR=0.72 [0.69, 0.76]; RD= -17.68 [-20.45, -14.91]), and mortality (HR=0.66 [0.60, 0.72]; RD= -8.48 [-10.14, -6.82]) vs DPP4i, without evidence of effect heterogeneity by demographic factors except for age on the RD scale. 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引用次数: 0
摘要
临床试验不足以检验恩格列净对2型糖尿病(T2D)患者的心血管益处是否均匀分布于人口统计学因素中。方法使用医疗保险数据(2014-2020年),我们比较了1:1倾向评分匹配的年龄≥65岁的T2D患者与启动恩格列净的DPP4i患者的主要不良心血管事件(MACE)、心力衰竭住院(HHF)和死亡率,总体和年龄(65-74岁,≥75岁)、性别、种族或民族,调整了155个基线混杂因素。我们以95%置信区间(CI)估计了发生率差异(RD)和风险比(HR),并评估了效果异质性。结果匹配后,恩格列净与DPP4i相比,MACE (HR [95% CI]=0.77 [0.72, 0.81]; RD= -10.10[-12.38, -7.83])、HHF (HR=0.72 [0.69, 0.76]; RD= -17.68[-20.45, -14.91])和死亡率(HR=0.66 [0.60, 0.72]; RD= -8.48[-10.14, -6.82])的风险降低相关,除年龄外,在RD量表上未发现人口统计学因素的影响异质性。具体来说,恩格列净在≥75岁和65-74岁的患者中提供了更大的绝对益处,每1000人年MACE事件减少17 vs 7, HHF事件减少25 vs 14,死亡人数减少12 vs 6。本研究表明,恩格列净对不同性别、种族或民族亚组的心血管结局和死亡率都有益处,尽管其绝对益处可能因年龄类别而异,在≥75岁的老年人中观察到的绝对益处程度更高,而65-74岁的老年人中观察到的绝对益处程度更高。
Effects of Demographics on Outcomes with Empagliflozin vs. DPP4i
Introduction
Clinical trials were underpowered to examine if cardiovascular benefits of empagliflozin in patients with type 2 diabetes (T2D) are evenly distributed across demographic factors.
Methods
Using Medicare data (2014-2020), we compared 1:1 propensity score-matched patients aged ≥65 years with T2D initiating empagliflozin vs a DPP4i for major adverse cardiovascular events (MACE), hospitalization for heart failure (HHF), and mortality, overall and by age (65-74, ≥75 years), sex, and race or ethnicity, adjusting for 155 baseline confounders. We estimated rate differences (RD) and hazard ratios (HR) with 95% confidence interval (CI) and assessed effect heterogeneity.
Results
After matching, empagliflozin was associated with decreased risk of MACE (HR [95% CI]=0.77 [0.72, 0.81]; RD= -10.10 [-12.38, -7.83]), HHF (HR=0.72 [0.69, 0.76]; RD= -17.68 [-20.45, -14.91]), and mortality (HR=0.66 [0.60, 0.72]; RD= -8.48 [-10.14, -6.82]) vs DPP4i, without evidence of effect heterogeneity by demographic factors except for age on the RD scale. Specifically, empagliflozin provided greater absolute benefits among patients aged ≥75 vs 65-74 years, with 17 vs. 7 fewer MACE events per 1000 person years, 25 vs. 14 fewer HHF events, and 12 vs 6 fewer deaths.
Conclusion
This study suggests that empagliflozin is beneficial for cardiovascular outcomes and mortality across subgroups of sex and race or ethnicity, though its absolute benefits may vary by age categories, with a higher degree of absolute benefit observed among older adults aged ≥75 vs 65-74 years.
期刊介绍:
Journal of the National Medical Association, the official journal of the National Medical Association, is a peer-reviewed publication whose purpose is to address medical care disparities of persons of African descent.
The Journal of the National Medical Association is focused on specialized clinical research activities related to the health problems of African Americans and other minority groups. Special emphasis is placed on the application of medical science to improve the healthcare of underserved populations both in the United States and abroad. The Journal has the following objectives: (1) to expand the base of original peer-reviewed literature and the quality of that research on the topic of minority health; (2) to provide greater dissemination of this research; (3) to offer appropriate and timely recognition of the significant contributions of physicians who serve these populations; and (4) to promote engagement by member and non-member physicians in the overall goals and objectives of the National Medical Association.