OBJECTIVES To compare diclofenac use before and after implementation of European risk minimization measures in 2013, focusing on diclofenac initiators and prevalence of congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease and cerebrovascular disease (new contraindications) in these patients in Germany. METHODS We included adults with health insurance coverage on 1 January 2011 (cohort 2011) or 1 January 2014 (cohort 2014) and during a 1-year pre-observation period. We defined diclofenac initiators as persons filling a prescription of systemic diclofenac in 2011 (cohort 2011) or 2014 (cohort 2014) and without such a prescription during the respective pre-observation period. RESULTS Each cohort comprised >10 million persons. Between 2011 and 2014, the age-standardized proportion of persons initiating diclofenac decreased by 29% (from 8.2% to 5.8%) amongst female patients and by 26% (from 8.5% to 6.3%) amongst male patients; in the subgroup of persons with new contraindications, this proportion decreased by 33% (from 9.8% to 6.6%) amongst female patients and by 31% (from 10.0% to 6.7%) amongst male patients. Amongst diclofenac initiators, the proportion of those with new contraindications did not change between 2011 (12.0%) and 2014 (11.8%). CONCLUSION The overall decline of about 30% in diclofenac initiation between 2011 and 2014 was largely independent of the presence or absence of new contraindications. The proportion of diclofenac initiators with a new contraindication remained at a high level (more than one in ten patients), demonstrating the need for research at the prescriber level (e.g. interventional studies) and further measures to improve patient safety.

中文翻译：

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处方者是否不了解双氯芬酸的心血管禁忌症？索赔数据分析。

目的比较2013年实施欧洲最小化风险措施前后双氯芬酸的使用情况，重点关注双氯芬酸的引发剂和充血性心力衰竭（NYHA II-IV级），缺血性心脏病，外周动脉疾病和脑血管疾病（新的禁忌症）的患病率这些病人在德国。方法我们纳入了在2011年1月1日（2011年队列）或2014年1月1日（2014年队列）和一年观察期前有健康保险的成年人。我们将双氯芬酸引发剂定义为在2011年（2011年队列）或2014年（2014年队列）服满全身性双氯芬酸处方的人，并且在各自的预观察期中没有此类处方。结果每个队列包括超过1000万人。在2011年至2014年之间，女性患者中双氯芬酸的起始年龄标准化比例下降了29％（从8.2％降至5.8％），男性患者中降低了26％（从8.5％降至6.3％）；在具有新禁忌症的亚组中，女性患者的这一比例下降了33％（从9.8％降至6.6％），而男性患者则下降了31％（从10.0％降至6.7％）。在双氯芬酸引发剂中，有新禁忌症的比例在2011年（12.0％）和2014年（11.8％）之间没有变化。结论2011年至2014年，双氯芬酸开始治疗的总体下降约30％，在很大程度上与是否存在新的禁忌症无关。具有新禁忌症的双氯芬酸引发剂的比例仍处于较高水平（十分之一以上的患者），