Objective: The aim of this study is to identify characteristics predicting the use of medication and/or psychotherapy after a first ADHD diagnosis. Method: This cohort study was based on German claims data including 12,250 treatment-naïve children aged 5 to 12 years with an incident ADHD diagnosis in 2010. Logistic regression models were used to estimate associations between children’s characteristics at first diagnosis and the chosen treatment within the following 5 years. Results: Medication use was associated with male sex, an ADHD diagnosis “with hyperactivity,” comorbid depression, and comorbid developmental and conduct disorders. Male sex and comorbid neurotic and somatoform, conduct, and emotional disorders were associated with psychotherapy only. Receiving both treatments—instead of medication only—was associated with comorbid depression, neurotic and somatoform, conduct, and emotional disorders. Conclusion: In case of equal access to both treatment options, patients, for example, with externalizing symptoms were more prone to receive medication and/or psychotherapy than the average child diagnosed with ADHD.

Our study suggests that a considerable proportion of children and adolescents with ADHD receive MPH in combination with APs and that this is a factor not only during the first years of MPH treatment. ADHD guidelines should specify algorithms concerning the use of AP medication.

PurposeTo describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency.MethodsNew users of cilostazol were identified in populations enrolled in five European health automated databases in the UK (The Health Improvement Network [THIN]), Spain (EpiChron cohort and Information System for the Improvement of Research in Primary Care [SIDIAP]), Sweden (National Registers), and Germany (German Pharmacoepidemiological Research Database [GePaRD]) between 2002 and 2012. New users were characterized according to the prevalence of cardiovascular disease and other comorbidities, concurrent use of interacting medications, new contraindications, duration of use, and potential off‐label prescribing.ResultsWe identified 22 593 new users of cilostazol. The median age was between 68.0 (THIN) and 73.7 (Sweden) years. More than 78% of users had concomitant cardiovascular disease, and between 78.8% (GePaRD) and 91.6% (THIN) were treated with interacting medications. Prevalence of new cardiovascular contraindications ranged from 1.5% (THIN) to 11.6% (GePaRD), and concurrent use of two or more antiplatelet drugs ranged from 6.3% (SIDIAP) to 13.5% (EpiChron cohort). Between 39.4% (Sweden) and 52.9% (THIN) of users discontinued cilostazol in the first 3 months. Between 41.0% (SIDIAP) and 93.4% (THIN) were considered to have received cilostazol according to the European Medicines Agency labeling.ConclusionsIn this collaborative European study, most cilostazol users were elderly patients with a high prevalence of cardiovascular diseases and other comorbidity and concurrent use of interacting drugs, indicating that this is a vulnerable population at high risk of complications, especially cardiovascular events. © 2017 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

are working and Christina Lindemann formerly at the Leibniz Institute for Prevention Research and Epidemiology-BIPS. BIPS occasionally conducts studies financed by the pharmaceutical industry. Almost exclusively, these are post-authorization safety studies (PASS) requested by health authorities. The studies and the resulting publications are not influenced by the pharmaceutical industry. The present work is unrelated to the above grants and relationships. The authors declare that they have no further conflicts of interest. There was no external support from any grant or funding source for this study. There are no commercial interests. This study was funded by the Leibniz Institute for Prevention Research and Epidemiology-BIPS.

ObjectivesTo 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.MethodsWe 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.ResultsEach 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%).ConclusionThe 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.