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.

Methods

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).

Results

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).

Conclusion

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.

中文翻译：

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私人投保的成年人使用质子泵抑制剂与组胺2受体拮抗剂的急性心肌梗死风险没有增加（2002-2014年）

背景与目标

质子泵抑制剂（PPI）是常用的药物。最近的研究报道，PPI使用者与非使用者相比，发生急性心肌梗塞（MI）的风险增加。与美国的私人投保成年人相比，我们评估了与PPI相关的MI风险与组胺2受体拮抗剂（H2RA）的相关性。

方法

使用商业和Medicare补充计划（2001-2014）的行政索赔，我们比较了开始新处方PPI和H2RA的患者发生MI的风险。从首次处方开始一直随访入选者，直至出现心梗，停药，取消计划或2014年12月31日为止。心梗是使用医院诊断代码定义的。在治疗开始后3个月，12个月和36个月，使用Kaplan-Meier方法评估了风险差异（RD），风险比和95％置信区间（CIs）。使用标准化的发病率权重来控制测得的混杂。分析按计划类型（商业与医疗保险补充计划）进行分层。

结果

我们确定了超过500万处方PPI和H2RA的新用户。商业保险患者的中位随访时间为60天，Medicare补充保险患者的中位随访时间为96天。MI的12个月加权风险总体较低（在商业计划中，每1000名患者中约2例；在Medicare补充计划中，每1000名患者中8例）。在RD分析中，我们发现，在商业人群（加权RD / 1000，-0.08； 95％CI，-0.51至0.36）或前12个月开始PPI与H2RA的患者之间，MI风险无显着差异。 Medicare补充人群（每千人的加权RD，-0.45； 95％CI，-1.53​​至0.58）。

结论

在对来自商业和Medicare补充计划的行政索赔进行的分析中，我们没有发现与处方H2RA相比处方PPI增加MI风险的证据。出于对MI风险的担忧，医生和患者不应避免开始PPI。