Kruik-Kollöffel Willemien J, van der Palen Job, van Herk-Sukel Myrthe P P, Kruik H Joost, Movig Kris L L
Department of Clinical Pharmacy, Saxenburgh Group, P.O. Box 1, 7770 AA, Hardenberg, The Netherlands.
Department of Clinical Pharmacy, Hospital Group Twente, Almelo, Hengelo, The Netherlands.
Clin Drug Investig. 2017 Aug;37(8):787-794. doi: 10.1007/s40261-017-0536-x.
In 2009 and 2010 medicines regulatory agencies published official safety statements regarding the concomitant use of proton pump inhibitors and clopidogrel. We wanted to investigate a change in prescription behaviour in prevalent gastroprotective drug users (2008-2011).
Data on drug use were retrieved from the Out-patient Pharmacy Database of the PHARMO Database Network. We used interrupted time series analyses (ITS) to estimate the impact of each safety statement on the number of gastroprotective drug switches around the start of clopidogrel and during clopidogrel use.
After the first statement (June 2009), significantly fewer patients switched from another proton pump inhibitor to (es)omeprazole (-14.9%; 95% CI -22.6 to -7.3) at the moment they started clopidogrel compared to the period prior to this statement. After the adjusted statement in February 2010, the switch percentage to (es)omeprazole decreased further (-4.5%; 95% CI -8.1 to -0.9). We observed a temporary increase in switches from proton pump inhibitors to histamine 2-receptor antagonists after the first statement; the decrease in the reverse switch was statistically significant (-23.0%; 95% CI -43.1 to -2.9).
With ITS, we were able to demonstrate a decrease in switches from other proton pump inhibitors to (es)omeprazole and an increase of the reverse switch to almost 100%. We observed a partial and temporary switch to histamine 2-receptor antagonists. This effect of safety statements was shown for gastroprotective drug switches around the start of clopidogrel treatment.
2009年和2010年，药品监管机构发布了关于质子泵抑制剂与氯吡格雷联合使用的官方安全声明。我们想要调查长期使用胃保护药物的患者（2008 - 2011年）的处方行为变化。
从PHARMO数据库网络的门诊药房数据库中检索用药数据。我们使用中断时间序列分析（ITS）来估计每项安全声明对氯吡格雷开始使用时及使用期间胃保护药物转换数量的影响。
在第一份声明（2009年6月）发布后，与该声明发布前的时期相比，开始使用氯吡格雷时从其他质子泵抑制剂转换为（埃索）美拉唑的患者显著减少（-14.9%；95%置信区间 -22.6至 -7.3）。在2010年2月的调整声明发布后，转换为（埃索）美拉唑的百分比进一步下降（-4.5%；95%置信区间 -8.1至 -0.9）。我们观察到在第一份声明发布后，从质子泵抑制剂转换为组胺2受体拮抗剂的情况暂时增加；反向转换的减少具有统计学意义（-23.0%；95%置信区间 -43.1至 -2.9）。
通过ITS，我们能够证明从其他质子泵抑制剂转换为（埃索）美拉唑的情况减少，反向转换增加至近100%。我们观察到部分且暂时转换为组胺2受体拮抗剂。这些安全声明的影响在氯吡格雷治疗开始时的胃保护药物转换中得到体现。
