Multi-country study Publications

• Impact of EMA regulatory label changes on systemic diclofenac initiation, discontinuation, and switching to other pain medicines in Scotland, England, Denmark, and The Netherlands.Abstract

  PURPOSE: In June 2013 a European Medicines Agency referral procedure concluded that diclofenac was associated with an elevated risk of acute cardiovascular events and contraindications, warnings, and changes to the product information were implemened across the European Union. This study measured the impact of the regulatory action on the prescribing of systemic diclofenac in Denmark, The Netherlands, England, and Scotland

  Morales DR, Morant SV, MacDonald TM, Mackenzie IS, Doney ASF, Mitchell L, Bennie M, Robertson C, Hallas J, Pottegard A, Ernst MT, Wei L, Nicholson L, Morris C, M CR, Overbeek JA, Smits E, W VR. Pharmacoepidemiol Drug Saf. 2020 Jan 4;

• No Evidence of Off-label Use of Olodaterol and Indacaterol in Denmark, France, and the Netherlands: A Drug Utilization Study.Abstract

  To characterize the use of olodaterol and indacaterol in clinical practice and to quantify the off-label use in asthma. Drug utilization study of new users of olodaterol or indacaterol between 2014 and 2017 in the PHARMO Database Network in the Neterlands, the Danish population registers, and the IMS Real-World Evidence Longitudinal Patient Database panels in France

  Rebordosa C, Houben E, Laugesen K, Bothner U, Montonen J, Aguado J, Overbeek JA, Ehrenstein V, Asmar J, Wallace L, Gilsenan AW. Sci Rep. 2020 Jan 17; 10 586.

• Real-world insights into risk of developing cardiovascular disease following GnRH agonists versus antagonists for prostate cancer: a methodological protocol to a study using five European databases.Abstract

  One of the more recently investigated adverse long-term side effects of gonadotropin-releasing hormone (GnRH) agonists for prostate cancer (PCa) is cardiovascular disease (CVD). Studies suggest lower risk of CVD following GnRH antagonists (degareli) than GnRH agonists. This protocol describes precise codes used to extract variables from five European databases for a study that compares risk of CVD following GnRH agonists and antagonists for PCa

  George G, Scailteux LM, Garmo H, Balusson F, Cardwell C, DeCoster G, DeSchutter H, Kuiper JG, McMenamin U, Verbeeck J, VanHemelrijck M. Fundam Clin Pharmacol. 2019 Feb 18; 33 479-499.

• Use of Topical Tacrolimus and Topical Pimecrolimus in Four European Countries: A Multicentre Database Cohort Study.Abstract

  BACKGROUND: Despite the concerns about a potential increased risk of skin cancer and lymphoma with the use of topical tacrolimus and pimecrolimus, no population-based studies have given an overview of the use of these drugs in Europe. OBJECTIVE: Toassess the use of topical tacrolimus and pimecrolimus in children and adults in Europe

  Kuiper JG, van Herk-Sukel MPP, Castellsague J, Pottegard A, Berglind IA, Dedman D, Gutierrez L, Calingaert B, Hallas J, Sundstrom A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S. Drugs Real World Outcomes. 2018 May 7; 5 109-116.

• Pioglitazone and cause-specific risk of mortality in patients with type 2 diabetes: extended analysis from a European multidatabase cohort study.Abstract

  Objectives: Describe and compare the risk of cardiovascular and non-cardiovascular mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of diseasprogression. Research design and methods: This exploratory linked database cohort analysis used pooled health and mortality data from three European countries: Finland, Sweden and the UK

  Strongman H, Christopher S, Majak M, Williams R, Bahmanyar S, Linder M, Heintjes EM, Bennett D, Korhonen P, Hoti F. BMJ Open Diabetes Res Care. 2018 6 e000481.

• Risk of acute myocardial infarction during use of individual NSAIDs: A nested case-control study from the SOS project.Abstract

  BACKGROUND: Use of selective COX-2 non-steroidal anti-inflammatory drugs (NSAIDs) (coxibs) has been associated with an increased risk of acute myocardial infarction (AMI). However, the risk of AMI has only been studied for very few NSAIDs that arerequently used. OBJECTIVES: To estimate the risk of AMI for individual NSAIDs

  Masclee GMC, Straatman H, Arfe A, Castellsague J, Garbe E, Herings R, Kollhorst B, Lucchi S, Perez-Gutthann S, Romio S, Schade R, Schink T, Schuemie MJ, Scotti L, Varas-Lorenzo C, Valkhoff VE, Villa M, Sturkenboom Mcjm. PLoS One. 2018 13 e0204746.

• A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation – JOELLE study).Abstract

  Background: There is a concern that topical tacrolimus and pimecrolimus, indicated for second-line treatment of atopic dermatitis, may increase the risk of lymphoma and skin cancer, particularly in children. Objective: The aim of this study was toompare incidence rates (IRs) of lymphoma and skin cancer between new users of topical tacrolimus or pimecrolimus and users of moderate- to high-potency topical corticosteroids (TCSs) and untreated subjects

  Castellsague J, Kuiper JG, Pottegard A, Anveden Berglind I, Dedman D, Gutierrez L, Calingaert B, van Herk-Sukel MP, Hallas J, Sundstrom A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S. Clin Epidemiol. 2018 10 299-310.

• How Representative are the Patients Included in the CV outcome Trials with SGLT2 Inhibitors of a General Type 2 Diabetes Population? A Large European Observational study.Abstract

  Birkeland K, Bode gard J, Norhammar A, Kuiper J, Georgiado E, Beekman-Hendriks W, Thuresson M, Pignot M, Herings R, Kooy A. Diabetes Obes Metab. 2018 21 968-974.

• Factors Associated with Type 2 Diabetes Mellitus Treatment Choice Across Four European Countries.Abstract

  PURPOSE: The aim of this analysis was to identify factors associated with the choice of type 2 diabetes mellitus (T2DM) therapy at the time of intensification of antidiabetic treatment across 4 European countries. METHODS: Antidiabetic drug prescrition/dispensing records and patients’ characteristics were obtained from the electronic health care records of patients with T2DM from the Netherlands (NL), Italy, and Spain (ES) (all, 2007-2011); and the United Kingdom (UK; 2008-2012)

  Heintjes EM, Overbeek JA, Hall GC, Prieto-Alhambra D, Lapi F, Hammar N, Bezemer ID. Clin Ther. 2017 Nov 03; 39 2296-2310.

• Exploring methods for comparing the real-world effectiveness of treatments for osteoporosis: adjusted direct comparisons versus using patients as their own control.Abstract

  Using Swedish and Dutch registry data for women initiating bisphosphonates, we evaluated two methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for differences in patient baseline characteristics. Eah method has advantages and disadvantages; both are potential complements to clinical trial analyses

  Karlsson L, Mesterton J, Tepie MF, Intorcia M, Overbeek J, Strom O. Arch Osteoporos. 2017 Sep 21; 12 81.