Background Lipid profiling is central for coronary artery disease (CAD) risk assessment. Nonadherence or unreported use of lipid-lowering drugs, particularly statins, can significantly complicate the association between lipid profile measures and CAD clinical outcomes. By combining medication history evaluation with statin analysis in plasma, we determined the effects of inaccurately reported statin use on lipid profile measures and their association with CAD risk. Methods We compared medication history of statin use with statin concentration measurements, by liquid chromatography–tandem mass spectrometry, in 690 participants undergoing coronary angiography (63 ± 11 years of age). Nominal logistic regression was employed to model CAD diagnosis with statin measurements, phenotypic, and lipid profile characteristics. Results Medication history of statin use was confirmed by statin assay for 81% of the patients. Surprisingly, statins were detected in 46% of patients without statin use records. Nonreported statin use was disproportionately higher among older participants. Stratifying samples by statin history resulted in underestimated LDL-lipid measures. Apolipoprotein B concentrations had a significant inverse CAD association, which became nonsignificant upon re-stratification using the statin assay data. Conclusions Our study uncovered prominent discrepancies between medication records and actual statin use measured by mass spectrometry. We showed that inaccurate statin use assessments may lead to overestimation and underestimation of LDL levels in statin user and nonuser categories, exaggerating the reverse epidemiology association between LDL levels and CAD diagnosis. Combining medication history and quantitative statin assay data can significantly improve the design, analysis, and interpretation of clinical and epidemiological studies.

中文翻译：

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不准确报告的他汀类药物使用影响血脂指标的评估及其与冠状动脉疾病风险的关联

背景 脂质分析是冠状动脉疾病 (CAD) 风险评估的核心。不依从或未报告使用降脂药物，特别是他汀类药物，可能会使血脂测量与 CAD 临床结果之间的关联变得显着复杂化。通过将用药史评估与血浆中他汀类药物分析相结合，我们确定了不准确报告的他汀类药物使用对血脂指标的影响及其与 CAD 风险的关联。方法 我们通过液相色谱-串联质谱法，对 690 名接受冠状动脉造影的参与者（63 ± 11 岁）的他汀类药物使用史与他汀类药物浓度测量结果进行了比较。采用名义逻辑回归通过他汀类药物测量、表型和血脂特征来模拟 CAD 诊断。结果 81%的患者通过他汀类药物检测证实了他汀类药物的用药史。令人惊讶的是，在没有他汀类药物使用记录的患者中，46% 的患者检测到了他汀类药物。未报告的他汀类药物使用情况在老年参与者中比例更高。按他汀类药物使用史对样本进行分层会导致低密度脂蛋白脂质测量值被低估。载脂蛋白 B 浓度与 CAD 存在显着的反向关联，但使用他汀类药物检测数据重新分层后，该关联变得不显着。结论 我们的研究发现用药记录与质谱测量的他汀类药物实际使用情况之间存在显着差异。我们发现，不准确的他汀类药物使用评估可能会导致高估和低估他汀类药物使用者和非使用者类别的 LDL 水平，夸大 LDL 水平与 CAD 诊断之间的反向流行病学关联。结合用药史和定量他汀类药物检测数据可以显着改善临床和流行病学研究的设计、分析和解释。