Serebruany Victor L, Cherepanov Vasily, Kim Moo Hyun, Litvinov Oleg, Cabrera-Fuentes Hector A, Marciniak Thomas A
HeartDrug™ Research Laboratories, Towson, MD, USA.
Cardiology. 2017;138(4):249-253. doi: 10.1159/000479786. Epub 2017 Sep 13.
The US Food and Drug Administration Adverse Event Reporting System (FAERS) is a global passive surveillance database that relies on voluntary reporting by health care professionals and consumers as well as required mandatory reporting by pharmaceutical manufacturers. However, the initial filers and comparative patterns for oral P2Y12 platelet inhibitor reporting are unknown. We assessed who generated original FAERS reports for clopidogrel, prasugrel, and ticagrelor in 2015.
From the FAERS database we extracted and examined adverse event cases coreported with oral P2Y12 platelet inhibitors. All adverse event filing originating sources were dichotomized into consumers, lawyers, pharmacists, physicians, other health care professionals, and unknown.
Overall, 2015 annual adverse events were more commonly coreported with clopidogrel (n = 13,234) with known source filers (n = 12,818, or 96.9%) than with prasugrel (2,896; 98.9% out of 2,927 cases) or ticagrelor (2,163, or 82.3%, out of 2,627 cases, respectively). Overall, most adverse events were filed by consumers (8,336, or 44.4%), followed by physicians (5,290, or 28.2%), other health care professionals (2,997, or 16.0%), pharmacists (1,125, or 6.0%), and finally by lawyers (129, or 0.7%). The origin of 811 (4.7%) initial reports remains unknown. The adverse event filing sources differ among drugs. While adverse events coreported with clopidogrel and prasugrel were commonly originated by patients (40.4 and 84.3%, respectively), most frequently ticagrelor reports (42.5%) were filed by physicians.
The reporting quality and initial sources differ among oral P2Y12 platelet inhibitors in FAERS. The ticagrelor surveillance in 2015 was inadequate when compared to clopidogrel and prasugrel. Patients filed most adverse events for clopidogrel and prasugrel, while physicians originated most ticagrelor complaints. These differences justify stricter compliance control for ticagrelor manufacturers and may be attributed to the confusion of treating physicians with unexpected fatal, cardiac, and thrombotic adverse events linked to ticagrelor.
美国食品药品监督管理局不良事件报告系统（FAERS）是一个全球被动监测数据库，它依赖于医疗保健专业人员和消费者的自愿报告以及制药商的强制报告。然而，口服P2Y12血小板抑制剂报告的初始提交者和比较模式尚不清楚。我们评估了2015年氯吡格雷、普拉格雷和替格瑞洛的FAERS原始报告是由谁生成的。
从FAERS数据库中提取并检查与口服P2Y12血小板抑制剂共同报告的不良事件病例。所有不良事件提交的来源分为消费者、律师、药剂师、医生、其他医疗保健专业人员和未知来源。
总体而言，2015年年度不良事件与氯吡格雷（n = 13234）共同报告的情况比与普拉格雷（2896例；2927例中的98.9%）或替格瑞洛（分别为2627例中的2163例，占82.3%）更为常见，已知来源提交者为12818例（96.9%）。总体而言，大多数不良事件是由消费者提交的（8336例，占44.4%），其次是医生（5290例，占28.2%）、其他医疗保健专业人员（2997例，占16.0%）、药剂师（1125例，占6.0%），最后是律师（129例，占0.7%）。811份（4.7%）初始报告的来源仍然未知。不同药物的不良事件提交来源不同。与氯吡格雷和普拉格雷共同报告的不良事件通常由患者发起（分别为40.4%和84.3%），而替格瑞洛报告最常见由医生提交（42.5%）。
FAERS中口服P2Y12血小板抑制剂的报告质量和初始来源各不相同。与氯吡格雷和普拉格雷相比，2015年替格瑞洛的监测不足。氯吡格雷和普拉格雷的大多数不良事件由患者提交，而替格瑞洛的大多数投诉由医生发起。这些差异证明对替格瑞洛制造商进行更严格的合规控制是合理的，并且可能归因于治疗医生对与替格瑞洛相关的意外致命、心脏和血栓性不良事件感到困惑。
