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Gini R, Pajouheshnia R , Gutierrez L , Swertz MA, Hyde E, Sturkenboom M, Arana A , Franzoni C , Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S . Commentary - Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): lessons learnt from the MINERVA project in Europe . Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5884. doi: 10.1002/pds.5884
Pajouheshnia R , Gini R, Gutierrez L , Swertz MA, Hyde E, Sturkenboom M, Arana A , Franzoni C , Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S . Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): development and pilot of a metadata list and catalogue in Europe . Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871
de Vogel S, Seeger JD, Arana A , Margulis AV , McQuay LJ, Perez-Gutthann S , Hallas J, Kristiansen NS, Linder M, Odsbu I, Suehs B, Xu Y, Uribe C, Appenteng K, Robinson NJ. Lessons learned from a multi-data source research collaboration: the mirabegron post-authorization safety study program . Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5799. doi: 10.1002/pds.5799
Rebordosa C , Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D , Garcia-Esteban R , Plana E , Tormos A , Farsani SF, Perez-Gutthann S , Pladevall-Vila M . Liver, renal, genitourinary, and diabetic ketoacidosis risks among new users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes: post-authorisation safety study based on multinational cohorts . Diabetes Obes Metab. 2024 Apr;26(4):1291-304. doi: 10.1111/dom.15429
Tormos A , Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D , Garcia Esteban R , Plana E , Farsani SF, Perez-Gutthann S , Pladevall-Vila M , Rebordosa C . Post-authorisation safety study (PASS) assessing the risk of liver, renal, genitourinary, and diabetic ketoacidosis outcomes among users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes mellitus (T2D) . Poster presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):585. doi: 10.1002/pds.5687
Wang SV, Pottegard A, Crown W, Arlett P, Ashcroft DM, Benchimol EI, Berger ML, Crane G, Goettsch W, Hua W, Kabadi S, Kern DM, Kurz X, Langan S, Nonaka T, Orsini L, Perez-Gutthann S , Pinheiro S, Pratt N, Schneeweiss S, Toussi M, Williams RJ. HARmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force . Pharmacoepidemiol Drug Saf. 2023 Jan;32(1):44-55. doi: 10.1002/pds.5507
Wang SV, Pottegard A, Crown W, Arlett P, Ashcroft DM, Benchimol EI, Berger ML, Crane G, Goettsch W, Hua W, Kabadi S, Kern DM, Kurz X, Langan S, Nonaka T, Orsini L, Perez-Gutthann S , Pinheiro S, Pratt N, Schneeweiss S, Toussi M, Williams RJ. HARmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR Task Force . Value Health. 2022 Oct 1;25(10):1663-72. doi: 10.1016/j.jval.2022.09.001
Gini R, Paoletti O, Pajouheshnia R , Souverein PC, Thurin NH, Ehrenstein V, Barreiro-De Acosta M, Sturkenboom M, Gutierrez L , Perez-Gutthann S . Study scripts supporting multiple common data models . Poster presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):550. doi: 10.1002/pds.5518Pharmacoepidemiol Drug Saf.2022;31(Suppl. 2):3–628.wileyonlinelibrary.com/journal/pds© 2022 John Wiley & Sons Ltd.3
Pajouheshnia R , Gini R, Hyde E, Swertz MA, Sturkenboom M, Margulis AV , Franzoni C , Arana A , Ehrenstein V, Gembert K, Jansen E, Herings RMC, Thurin NH, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Zaccagnino S, Busto MP, Middelkoop B, Barreiro-De Acosta M, Saez FS, Rodriguez-Bernal C, Sanfelix-Gimeno G, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Gil M, Schafer W, Haug U, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Gutierrez L , Perez-Gutthann S . MINERVA: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies . Poster presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):564. doi: 10:1002/pds.5518
Gilsenan AW , Sturkenboom MC, de Luise C, Cohet C, Anderson SA, Brown J, Foskett N, Perez-Gutthann S . COVID-19 vaccine safety monitoring: opportunities, challenges and lessons learned for pharmacoepidemiology . Presented at the 2022 ICPE Conference; August 27, 2022. Copenhagen, Denmark.
Rebordosa C , Plana E , Rubino A, Aguado J , Martinez D , Lei A, Daoud S, Saigi-Morgui N , Perez-Gutthann S , Rivero-Ferrer E . Risk assessment of acute myocardial infarction and stroke associated with long-acting muscarinic antagonists, alone or in combination, versus long-acting beta2-agonists . Int J Chron Obstruct Pulmon Dis. 2022 Aug 2;17:1715-33. doi: 10.2147/COPD.S363997
Saigi-Morgui N , Rebordosa C , Plana E , Rubino A, Aguado J , Martinez D , Lei A, Daoud SZ, McMahon P, Perez-Gutthann S , Rivero-Ferrer E . Acute myocardial infarction, stroke, and MACE in COPD patients treated with aclidinium and other inhaled bronchodilators . Poster presented at the 2022 ICPE Conference; August 2022. Copenhagen, Denmark.
Beau-Lejdstrom R, Hong LS, Garcia de Albeniz X , Floricel F, Lorenzen J, Bonfitto F, Kalilani L, Loesch C, Luscombe G, Perez-Gutthann S , Mottet I, Foskett N. Incidence of acute renal failure in patients using Levetiracetam versus other antiseizure medications: a voluntary post-authorization safety study . Drug Saf. 2022 Jul;45(7):781-90. doi: 10.1007/s40264-022-01193-0
Rivero-Ferrer E , Olesen M, Plana E , Aguado J , Saigi-Morgui N , Rubino A, Daoud SZ, Lei A, Perez-Gutthann S , Schink S, Kristiansen NS, Hallas J, Pottegard A, Rebordosa C . Characteristics of new users of aclidinium bromide, aclidinium/formoterol, and other COPD medications in the United Kingdom, Denmark, and Germany . Clin Drug Invest. 2022 Apr;42(4):319-31. doi: 10.1007/s40261-022-01120-2
Arana A , Pottegard A, Kuiper J, Booth H, Reutfors J, Calingaert B , Lund LC, Crellin E, Schmitt-Egenolf M, Kaye J, Gembert K, Rothman K , Kieler H, Dedman D, Houben E, Gutierrez L , Hallas J, Perez-Gutthann S . Long-term risk of skin cancer and lymphoma in users of topical tacrolimus and pimecrolimus: final results from the extension of the cohort study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE) . Clin Epidemiol. 2021 Dec 29;2021(13):1141-53. doi: 10.2147/CLEP.S331287
Fortuny J , von Gersdorff G, Lassalle R, Linder M, Overbeek J, Reinold J, Toft G, Timmer A, Dress J, Blin P, Droz-Perroteau C, Ehrenstein V, Franzoni C , Herings R, Kollhorst B, Moore N, Odsbu I, Perez-Gutthann S , Schink T, Rascher K, Rasouliyan L, Rothman KJ , Saigi-Morgui N , Schaller M, Smits E, Forstner M, Intravenous Iron Consortium, Benichou J, Bircher AJ, Garbe E, Rampton DS, Gutierrez L . Use of intravenous iron and risk of anaphylaxis: a multinational observational post-authorisation safety study in Europe . Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1447-57. doi: 10.1002/pds.5319
Hoffman V, Hallas J, Linder M, Margulis AV , Suehs BT, Arana A , Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S , Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD. Cardiovascular risk in users of mirabegron relative to users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, real-world data safety study . Presented at the Virtual ICPE 2021 Conference; August 24, 2021. Previously presented at the 2020 Virtual American Heart Association’s Scientific Sessions.
Kuiper JG, Franzoni C , Ehrenstein V, Gini R, Haug U, Moore N, Droz-Perroteau C, Bolibar B, Giner-Soriano M, Hallas J, MacDonald T, Sturkenboom M, Klungel OH, Perez-Gutthann S , Herings RM. The SIGMA Consortium: a new era of collaboration to study the safety and effectiveness of medical interventions . Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.
Hoffman V , Hallas J, Linder M, Margulis AV , Suehs BT, Arana A , Phiri K, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S , Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD, mirabegron PMR-PASS study group. Cardiovascular risk in users of mirabegron compared with users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, multinational, cohort study . Drug Saf. 2021 Aug;44(8):899-915. doi: 10.1007/s40264-021-01095-7
Phiri K, Hallas J, Linder M, Margulis A , Suehs B, Arana A , Bahmanyar S, Hoffman V , Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S , Kristiansen NS, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder . Curr Med Res Opin. 2021 May;37(5):867-77. doi: 10.1080/03007995.2021.1891035
Arana A , Margulis AV , Varas-Lorenzo C, Bui CL , Gilsenan A , McQuay LJ, Reynolds M , Rebordosa C , Franks B, de Vogel S, Appenteng K, Perez-Gutthann S . Validation of cardiovascular outcomes and risk factors in the Clinical Practice Research Datalink in the United Kingdom . Pharmacoepidemiol Drug Saf. 2021 Feb;30(2):237-47. doi: 10.1002/pds.5150
Ali MS, Berencsi K, Marinier K, Deltour N, Perez-Gutthann S , Pedersen L, Rijnbeek P, Lapi F, Simonetti M, Reyes C, Van der Lei J, Sturkenboom M, Prieto-Alhambra D. Comparative cardiovascular safety of strontium ranelate and bisphosphonates: a multi-database study in 5 EU countries by the EU-ADR Alliance . Osteoporos Int. 2020 Dec;31(12):2425-38.
Hoffman V, Hallas J, Linder M, Margulis A , Suehs BT, Arana A , Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S , Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD. Cardiovascular risk in users of mirabegron relative to users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, real-world data safety study . Poster presented at the 2020 Virtual American Heart Association’s Scientific Sessions; November 13, 2020.
Arana A , Pottegard A, Kuiper JG, Crellin E, Reutfors J, Schmitt-Egenolf M, Lund LC, Houben E, Booth H, Calingaert B , Kaye JA, Gembert K, Rothman KJ , Dedman D, Kieler H, Gutierrez L , Hallas J, Perez-Gutthann S . To what extent are topical tacrolimus or pimecrolimus associated with an increased risk of skin cancer and lymphoma? Long-term results from JOELLE study . Poster presented at the 2020 Virtual European Academy of Dermatology and Venereology Conference; October 29, 2020. Previously presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management.
Rebordosa C , Rubino A, Witzleb AJ, Olesen M, Plana E , Aguado J , Saigi N , Daoud SZ, Lei A, Perez-Gutthann S , Schink T, Kristiansen NS, Pottegard A, Rivero-Ferrer E . Characteristics of new users of aclidinium, aclidinium/formoterol, and other COPD medications in three European countries . Poster presented at the 2020 Virtual ERS International Congress; October 2020. [abstract] Eur Respir J. 2020 Oct 28; 56(Suppl 64):2071. doi: 10.1183/13993003.congress-2020.2072
Arana A , Pottegard A, Kuiper JG, Crellin E, Reutfors J, Schmitt-Egenolf M, Lund LC, Houben E, Booth H, Calingaert B , Kaye JA, Gembert K, Rothman KJ , Dedman D, Kieler H, Gutierrez L , Hallas J, Perez-Gutthann S . To what extent are topical tacrolimus or pimecrolimus associated with increased risk of skin cancer and lymphoma? Long-term results from Joelle Study . Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Gutierrez L , Blin P, Dress J, Droz-Perroteau C, Ehrenstein V, Franzoni C , Kollhorst B, Lassalle R, Linder M, Moore N, Odsbu I, Overbeek J, Perez-Gutthann S , Schink T, Rascher K, Rasouliyan L, Reinold J, Rothman KJ , Saigi-Morgui N , Schaller M, Smits E, Timmer A, Toft G, von Gersdorff G, Intravenous Iron Consortium, Fortuny J . A multinational European study of anaphylaxis among recipients of intravenous iron . Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
de Vogel S, Hoffman V , Phiri K, Seeger J, Arana A , Margulis A , McQuay L, Perez-Gutthann S , Hallas J, Sahlertz Kristiansen N, Suehs B, Uribe C, Appenteng K, Robinson NJ. The Mirabegron Post-marketing Requirements (PMRs)/ Non-interventional Post-authorization Safety Study (NI-PASS) Program . Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Rivero-Ferrer E , Witzleb AJ, Olesen M, Plana E , Aguado J , Saigi-Morgui N , Rubino A, Daoud SZ, Lei A, Perez-Gutthann S , Schink T, Kristiansen NS, Pottegard A, Rebordosa C . Are aclidinium and aclidinium/formoterol used according to their approved indication in Europe? Results of a multicountry drug utilization postauthorization safety study . Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Phiri K, Hallas J, Linder M, Margulis A , Suehs B, Arana A , Bahmanyar S, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S , Sahlertz Kristiansen N, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder . Presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 2020.
Berencsi K, Sami A, Ali MS, Marinier K, Deltour N, Perez-Gutthann S , Pedersen L, Rijnbeek P, Van der Lei J, Lapi F, Simonetti M, Reyes C, Sturkenboom MCJM, Prieto-Alhambra D. Impact of risk minimisation measures on the use of strontium ranelate in Europe: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance . Osteoporos Int. 2020 Apr;31(4):721-55. doi: 10.1007/s00198-020-05314-2
Phiri K, Hallas J, Linder M, Margulia A , Suehs B, Arana A , Bahmanyar S, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S , Sahlertz Kristiansen N, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder . Poster presented at the American Urological Association 2020 Conference (Conference cancelled); May 2020. Washington, DC. [abstract] J Urol. 2020 Apr; 203(Supplement 4):e910-1. doi: 10.1097/JU.0000000000000931.010
Gutierrez L , Bezemer ID, Dress J, Ehrenstein V, Forstner M, Franzoni C , Lassalle R, Linder M, Droz-Perroteau C, Odsbu I, Overbeek JA, Perez-Gutthann S , Pisa FE, Rascher K, Rasouliyan L, Reinold J, Rothman KJ , Saigi-Morgui N , Schaller M, Smits E, Timmer A, Toft G, von Gersdorff G, Fortuny J . Challenges in conducting a multinational European study of severe hypersensitivity reactions among recipients of intravenous iron . Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):640. doi: 10.1002/pds.4864
Plana E , Rivero-Ferrer E , Aguado J , Saigi-Morgui N , Nuevo J, Daoud SZ, Lei A, Perez-Gutthann S , Rebordosa C . Hospitalization for heart failure among patients using aclidinium bromide and other COPD medications: a post-authorisation safety study in the CPRD . Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):1153. doi: 10.1002/pds.4864
Saigi N , Rebordosa C , Bui C , Aguado J , Plana E , Nuevo J, Daoud SZ, Lei A, Perez-Gutthann S , Rivero-Ferrer E . A validation exercise: identifying hospitalizations for heart failure among patients with COPD in the CPRD . Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):334. doi: 10.1002/pds.4864
Forns J , Pottegard A, Reinders T, Poblador-Plou B, Morros R, Brandt L, Cainzos-Achirica M, Hellfritzsch M, Schink T, Prados-Torres A, Giner-Soriano M, Hallas J, Cortes J, Hagg D, Jacquot E, Deltour N, Perez-Gutthann S , Pladevall M , Reutfors J. Antidepressant use in Denmark, Germany, Spain, and Sweden from 2009 to 2014: incidence and comorbidities of antidepressant initiators . Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):560. doi: 10.1002/pds.4864
Forns J , Cainzos-Achirica M, Hellfritzsch M, Morros R, Poblador-Plou B, Hallas J, Giner-Soriano M, Prados-Torres A, Pottegard A, Cortes J, Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S , Pladevall M . Validity of ICD-9 and ICD-10 codes used to identify acute liver injury: a study in three European data sources . Pharmacoepidemiol Drug Saf. 2019 Jul;28(7):965-75. doi: 10.1002/pds.4803