School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeonggi-do, South Korea. Email:
Am J Manag Care. 2019 Nov 1;25(11):e342-e348.
This study was conducted to determine the number of pioglitazone users before and after the issue of the pioglitazone safety warning (intervention) by South Korea's Ministry of Food and Drug Safety on June 10, 2011.
A quasi-experimental interrupted time series study was conducted to examine the number of pioglitazone and other antidiabetic drug users between 2009 and 2015.
We used the National Health Insurance Service-National Sample Cohort database to estimate the number of pioglitazone and other antidiabetic drug users between 2009 and 2015. Relative and absolute changes in the number of drug users were calculated with 95% CIs. Monthly numbers of drug users were presented according to the maximum likelihood estimation method, and a segmented regression analysis was performed to evaluate the effect of the intervention. A Durbin-Watson statistic and Dickey-Fuller test were used to assess autocorrelation and seasonality, respectively.
A total of 80,724 patients with diabetes, including 12,249 pioglitazone users, were investigated. The relative change in pioglitazone users was -8.13% (95% CI, -8.41% to -7.86%). The intervention was associated with an immediate decrease of 177 pioglitazone users per 1000 patients with diabetes (P <.05). Without this intervention, the predicted proportion of pioglitazone users would be 90 per 1000 patients with diabetes, which is 1.5-fold higher than the actually observed rate of 60 per 1000 patients with diabetes.
This intervention led to a moderate decrease in pioglitazone users. Until further evidence is available, caution should be exercised when prescribing pioglitazone to patients with high potential risk of bladder cancer and alternative treatments should be considered.
本研究旨在确定 2011 年 6 月 10 日韩国食品药品安全部发布吡格列酮安全性警告（干预）前后吡格列酮使用者的数量。
采用准实验性中断时间序列研究，于 2009 年至 2015 年期间，考察吡格列酮和其他抗糖尿病药物使用者的数量。
我们使用国家健康保险服务-国家样本队列数据库来估计 2009 年至 2015 年期间吡格列酮和其他抗糖尿病药物使用者的数量。使用 95%置信区间计算药物使用者数量的相对和绝对变化。根据最大似然估计法呈现药物使用者的月数量，并进行分段回归分析以评估干预的效果。使用 Durbin-Watson 统计量和 Dickey-Fuller 检验分别评估自相关和季节性。
共纳入 80724 例糖尿病患者，其中 12249 例为吡格列酮使用者。吡格列酮使用者的相对变化为-8.13%（95%CI，-8.41%至-7.86%）。干预与糖尿病患者每 1000 人减少 177 名吡格列酮使用者相关（P <.05）。如果没有这种干预，预计每 1000 名糖尿病患者中使用吡格列酮的比例将为 90 例，这比实际观察到的每 1000 名糖尿病患者中 60 例的使用比例高 1.5 倍。
该干预措施导致吡格列酮使用者数量适度减少。在获得进一步证据之前，应谨慎使用吡格列酮治疗膀胱癌高危患者，并考虑替代治疗方法。
