Duh Mei Sheng, Cremieux Pierre, Audenrode Marc Van, Vekeman Francis, Karner Paul, Zhang Haimin, Greenberg Paul
Analysis Group, Inc., Boston, MA, USA.
Groupe d'analyse, Ltée, Montréal, QC, Canada.
Pharmacoepidemiol Drug Saf. 2016 Dec;25(12):1425-1433. doi: 10.1002/pds.4090. Epub 2016 Sep 7.
To compare the patient characteristics and the inter-temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor ) and sibutramine (Meridia ) in social media (AskaPatient.com) versus the FDA Adverse Event Reporting System (FAERS).
We identified clinically important AEs associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), compared their patterns in social media postings versus FAERS and used Granger causality tests to assess whether social media postings were useful in forecasting FAERS reports.
We analyzed 998 and 270 social media postings between 2001 and 2014, 69 003 and 7383 FAERS reports between 1997 and 2014 for atorvastatin and sibutramine, respectively. Social media reporters were younger (atorvastatin: 53.9 vs. 64.0 years, p < 0.001; sibutramine: 36.8 vs. 43.8 years, p < 0.001). Social media reviews contained fewer serious AEs (atorvastatin, pain: 2.5% vs. 38.2%; sibutramine, cardiovascular issues: 7.9% vs. 63.0%; p < 0.001 for both) and concentrated on fewer types of AEs (proportion comprising the top 20 AEs: atorvastatin, 88.7% vs. 55.4%; sibutramine, 86.3% vs. 65.4%) compared with FAERS. While social media sibutramine reviews mentioning cardiac issues helped predict those in FAERS 11 months later (p < 0.001), social media atorvastatin reviews did not help predict FAERS reports.
Social media AE reporters were younger and focused on less-serious and fewer types of AEs than FAERS reporters. The potential for social media to provide earlier indications of AEs compared with FAERS is uncertain. Our findings highlight some of the promises and limitations of online social media versus conventional pharmacovigilance sources and the need for careful interpretation of the results. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
比较社交媒体(AskaPatient.com)与美国食品药品监督管理局不良事件报告系统(FAERS)中阿托伐他汀(立普妥)和西布曲明(诺美亭)的患者特征及不良事件(AE)的跨期报告模式。
我们确定了与阿托伐他汀(肌肉疼痛)和西布曲明(心血管不良事件)相关的具有临床重要性的不良事件,比较了它们在社交媒体帖子与FAERS中的模式,并使用格兰杰因果检验来评估社交媒体帖子是否有助于预测FAERS报告。
我们分别分析了2001年至2014年间的998条和270条社交媒体帖子,以及1997年至2014年间阿托伐他汀和西布曲明在FAERS中的69003份和7383份报告。社交媒体报告者更年轻(阿托伐他汀:53.9岁对64.0岁,p<0.001;西布曲明:36.8岁对43.8岁,p<0.001)。与FAERS相比,社交媒体评论中包含的严重不良事件较少(阿托伐他汀,疼痛:2.5%对38.2%;西布曲明,心血管问题:7.9%对63.0%;两者p均<0.001),且集中在较少类型的不良事件上(构成前20种不良事件的比例:阿托伐他汀,88.7%对55.4%;西布曲明,86.3%对65.4%)。虽然提及心脏问题的社交媒体西布曲明评论有助于预测11个月后FAERS中的报告(p<0.001),但社交媒体阿托伐他汀评论无助于预测FAERS报告。
与FAERS报告者相比,社交媒体不良事件报告者更年轻,关注的不良事件不太严重且类型较少。与FAERS相比,社交媒体提供不良事件早期迹象的可能性尚不确定。我们的研究结果凸显了在线社交媒体与传统药物警戒来源相比的一些前景和局限性,以及对结果进行谨慎解读的必要性。©2016作者。《药物流行病学与药物安全》由约翰·威利父子有限公司出版。