Noh Yoojin, Kang Dae Ryong, Kim Dae Jung, Lee Kwang Jae, Lee Sukhyang, Shin Sooyoung
College of Pharmacy, Ajou University, Suwon, Gyeonggi-do, South Korea.
Center of Biomedical Data Science/Institute of Genomic Cohort, Wonju College of Medicine, Yonsei University, Wonju, Gangwon-do, South Korea.
Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1338-1346. doi: 10.1002/pds.4262. Epub 2017 Aug 3.
Cardiovascular safety alerts about rosiglitazone resulted in regulatory actions in several countries in 2010, but the Food and Drug Administration eliminated access restrictions in 2013, reflecting new evidence concerning the drug safety. We investigated the effects of safety signals and regulation shifts concerning rosiglitazone on prescribing of antidiabetic drugs (ADs).
Patient data were extracted from the Korean health insurance claims database for 2007 to 2015. Linear regression and interrupted time series analyses were performed to examine drug utilization trends and the impact of 5 milestone events regarding rosiglitazone safety on AD utilization.
A steady growth was observed in the AD consumption, with metformin preserving its dominant market share throughout the period. Pioglitazone use has increased since 2008 in response to safety issues surrounding rosiglitazone. A significant decline in rosiglitazone use was observed after Nissen's meta-analysis and safety warnings (2007) and after restriction/suspension of access to rosiglitazone (2010), associated with a drop in prevalence by 29.5%/year and 99.5%/year, respectively. The most common AD newly started among users who discontinued rosiglitazone in 2010 was pioglitazone, followed by dipeptidyl peptidase-4 (DPP-4) inhibitors. Our concomitancy analysis showed that DPP-4 inhibitors have overtaken sulfonylureas since 2014 as the most common add-on to metformin.
The most frequently added AD in diabetes patients who had switched off rosiglitazone in 2010 was pioglitazone, followed by DPP-4 inhibitors. Despite new evidence from a long-term clinical trial and the Food and Drug Administration's subsequent decision to eliminate access restrictions on rosiglitazone in 2013, domestic regulations were left intact; hence, its use remained negligible in Korea.
关于罗格列酮的心血管安全警报在2010年导致多个国家采取监管行动，但美国食品药品监督管理局在2013年取消了使用限制，这反映了有关该药物安全性的新证据。我们调查了罗格列酮的安全信号和监管变化对降糖药物（AD）处方的影响。
从韩国健康保险理赔数据库中提取2007年至2015年的患者数据。进行线性回归和中断时间序列分析，以检查药物使用趋势以及罗格列酮安全性方面的5个里程碑事件对AD使用的影响。
观察到AD消费量稳步增长，二甲双胍在此期间一直保持其主导市场份额。自2008年以来，由于罗格列酮周围的安全问题，吡格列酮的使用有所增加。在尼森的荟萃分析和安全警告（2007年）之后以及罗格列酮使用受限/暂停（2010年）之后，观察到罗格列酮的使用显著下降，患病率分别下降29.5%/年和99.5%/年。2010年停用罗格列酮的使用者中，新开始使用的最常见AD是吡格列酮，其次是二肽基肽酶-4（DPP-4）抑制剂。我们的联合用药分析表明，自2014年以来，DPP-4抑制剂已超过磺脲类药物，成为二甲双胍最常见的联合用药。
2010年停用罗格列酮的糖尿病患者中，最常添加的AD是吡格列酮，其次是DPP-4抑制剂。尽管有长期临床试验的新证据以及美国食品药品监督管理局随后在2013年取消罗格列酮使用限制的决定，但国内法规保持不变；因此罗格列酮在韩国的使用仍然微不足道。
