Adverse drug events (ADEs) account for a significant mortality, morbidity, and cost burden. Pharmacogenetic testing has the potential to reduce ADEs and inefficacy. The objective of this INGENIOUS trial (NCT02297126) analysis was to determine whether conducting and reporting pharmacogenetic panel testing impacts ADE frequency. The trial was a pragmatic, randomized controlled clinical trial, adapted as a propensity matched analysis in individuals (N = 2612) receiving a new prescription for one or more of 26 pharmacogenetic-actionable drugs across a community safety-net and academic health system. The intervention was a pharmacogenetic testing panel for 26 drugs with dosage and selection recommendations returned to the health record. The primary outcome was occurrence of ADEs within 1 year, according to modified Common Terminology Criteria for Adverse Events (CTCAE). In the propensity-matched analysis, 16.1% of individuals experienced any ADE within 1-year. Serious ADEs (CTCAE level ≥ 3) occurred in 3.2% of individuals. When combining all 26 drugs, no significant difference was observed between the pharmacogenetic testing and control arms for any ADE (Odds ratio 0.96, 95% CI: 0.78–1.18), serious ADEs (OR: 0.91, 95% CI: 0.58–1.40), or mortality (OR: 0.60, 95% CI: 0.28–1.21). However, sub-group analyses revealed a reduction in serious ADEs and death in individuals who underwent pharmacogenotyping for aripiprazole and serotonin or serotonin-norepinephrine reuptake inhibitors (OR 0.34, 95% CI: 0.12–0.85). In conclusion, no change in overall ADEs was observed after pharmacogenetic testing. However, limitations incurred during INGENIOUS likely affected the results. Future studies may consider preemptive, rather than reactive, pharmacogenetic panel testing.

药物不良事件 (ADE) 造成显着的死亡率、发病率和成本负担。药物遗传学测试有可能减少 ADE 和无效性。这项 INGENIOUS 试验 (NCT02297126) 分析的目的是确定进行和报告药物遗传学小组测试是否会影响 ADE 频率。该试验是一项务实的随机对照临床试验，对 在社区安全网和学术卫生系统中接受 26 种药物遗传学可行药物中的一种或多种新处方的个体 ( N = 2612) 进行倾向匹配分析。干预措施是对 26 种药物进行药物遗传学测试，并将剂量和选择建议返回到健康记录中。根据修订后的不良事件通用术语标准 (CTCAE)，主要结局是 1 年内发生 ADE。在倾向匹配分析中，16.1% 的人在 1 年内经历过任何 ADE。3.2% 的个体发生严重 ADE（CTCAE 水平≥ 3）。当组合所有 26 种药物时，对于任何 ADE（比值比 0.96，95% CI：0.78–1.18）、严重 ADE（OR：0.91，95% CI：0.58–1.40），药物遗传学测试和对照组之间没有观察到显着差异。 ，或死亡率（OR：0.60，95% CI：0.28–1.21）。然而，亚组分析显示，接受阿立哌唑和血清素或血清素-去甲肾上腺素再摄取抑制剂药物基因分型的个体的严重不良事件和死亡有所减少（OR 0.34，95% CI：0.12-0.85）。总之，药物遗传学测试后未观察到总体 ADE 发生变化。然而，INGENIOUS 期间发生的限制可能会影响结果。未来的研究可能会考虑先发制人的药物遗传学小组测试，而不是反应性的药物遗传学小组测试。