Division of Pharmacovigilance and Medical Devices, Danish Medicines Agency, Copenhagen, Denmark.
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands.
Br J Clin Pharmacol. 2022 Mar;88(3):1379-1384. doi: 10.1111/bcp.15080. Epub 2021 Oct 8.
This study aimed to evaluate the impact of the risk minimisation measures issued by the European Medicines Agency in 2014 to restrict the combined use of renin-angiotensin system (RAS) blocking agents in Denmark. Data from the Danish National Prescription Registry covering all medications dispensed during January 2008-December 2018 was used. The outcome was monthly prevalence of patients codispensed RAS blockers. Autoregressive integrated moving average interrupted time series regression was used to evaluate dispensing trends. The prevalence of patients codispensed RAS blockers decreased from 0.01 to 0.0003%. Preintervention trend was declining and further decreased with an additional -0.45 (95% confidence interval -0.66, -0.25) codispensing per million population after the intervention. Overall, the intervention had minimal impact on the combined use of RAS blockers. However, as the combined use of RAS blockers is low, further interventions to restrict the combined use of RAS blockers may not be required in Denmark at this point.
这项研究旨在评估 2014 年欧洲药品管理局发布的风险最小化措施对丹麦限制肾素-血管紧张素系统（RAS）阻断剂联合使用的影响。该研究使用了丹麦全国处方登记处的数据，涵盖了 2008 年 1 月至 2018 年 12 月期间的所有药物。结果是每月联合使用 RAS 阻滞剂的患者比例。自回归积分移动平均干预时间序列回归用于评估配药趋势。联合使用 RAS 阻滞剂的患者比例从 0.01 降至 0.0003%。干预前趋势呈下降趋势，干预后每百万人口增加 0.45（95%置信区间-0.66，-0.25）联合配药后进一步下降。总体而言，干预措施对 RAS 阻滞剂的联合使用影响不大。然而，由于 RAS 阻滞剂的联合使用率较低，目前在丹麦可能不需要进一步限制 RAS 阻滞剂联合使用的干预措施。
