Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina.
Gastroenterology. 2018 Mar;154(4):861-873.e6. doi: 10.1053/j.gastro.2017.10.042. Epub 2017 Nov 6.
BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are commonly used medications. Recent studies reported an increased risk of acute myocardial infarction (MI) in PPI users vs non-users. We evaluated MI risk associated with PPIs compared with histamine-2 receptor antagonists (H2RAs) in privately insured adults in the United States.
Using administrative claims from commercial and Medicare Supplemental plans (2001-2014), we compared risk of MI in patients who started a new prescription for PPIs vs H2RAs. Enrollees were followed from their first prescription until MI, medication discontinuation, plan disenrollment, or December 31, 2014. MI was defined using hospital diagnosis codes. Risk differences (RD), risk ratios, and 95% confidence intervals (CIs) were estimated using Kaplan-Meier methods at 3, 12, and 36 months after treatment initiation. Standardized morbidity ratio weights were used to control measured confounding. Analyses were stratified by plan type (commercial vs Medicare Supplemental).
We identified more than 5 million new users of prescription PPIs and H2RAs. Median follow-up time was 60 days for patients with commercial insurance and 96 days in patients with Medicare Supplemental insurance. The 12-month weighted risk of MI was low overall (approximately 2 cases per 1000 among patients in commercial plans; 8 per 1000 among patients in Medicare Supplemental plans). In the RD analysis, we found no significant differences in MI risk between patients who started PPIs vs H2RAs for the first 12 months, either in the commercial population (weighted RD per 1000, -0.08; 95% CI, -0.51 to 0.36) or the Medicare Supplemental population (weighted RD per 1000, -0.45; 95% CI, -1.53 to 0.58).
In an analysis of administrative claims from commercial and Medicare Supplemental plans, we found no evidence that prescription PPIs increase risk of MI compared with prescription H2RAs. Physicians and patients should not avoid starting a PPI because of concerns related to MI risk.
质子泵抑制剂（PPIs）是常用药物。最近的研究报告称，PPI 使用者发生急性心肌梗死（MI）的风险高于非使用者。我们评估了与组胺 2 受体拮抗剂（H2RAs）相比，PPI 在美国私人保险成年人中与 MI 相关的风险。
使用来自商业和 Medicare 补充计划的行政索赔数据（2001-2014 年），我们比较了开始新处方 PPI 与 H2RA 的患者发生 MI 的风险。参保人从他们的第一份处方开始，直至发生 MI、药物停药、计划退保或 2014 年 12 月 31 日。MI 通过医院诊断代码定义。使用 Kaplan-Meier 方法在治疗开始后 3、12 和 36 个月估计风险差异（RD）、风险比和 95%置信区间（CI）。使用标准化发病率比权重来控制已测量的混杂。分析按计划类型（商业与 Medicare 补充）进行分层。
我们确定了超过 500 万例新使用处方 PPI 和 H2RA 的患者。商业保险患者的中位随访时间为 60 天，Medicare 补充保险患者为 96 天。总体而言，12 个月加权 MI 风险较低（商业计划中约为每 1000 例患者 2 例；Medicare 补充计划中每 1000 例患者 8 例）。在 RD 分析中，我们发现，在商业人群中（每 1000 例患者加权 RD，-0.08；95%CI，-0.51 至 0.36）或 Medicare 补充人群中（每 1000 例患者加权 RD，-0.45；95%CI，-1.53 至 0.58），在最初 12 个月内，PPI 与 H2RA 相比，患者的 MI 风险没有显著差异。
在对商业和 Medicare 补充计划的行政索赔数据进行分析时，我们没有发现处方 PPI 与 MI 风险增加相关的证据，与处方 H2RA 相比。医生和患者不应因与 MI 风险相关的担忧而避免开始使用 PPI。
