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Publications
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, Gembrt K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Barreiro-de Acosta M, 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: 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, Barreiro-de Acosta M, 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
Johannes CB , Beachler DC, Layton JB , Danysh HE , Ziemiecki R , Arana A , Dinh J, Li L, Calingaert B , Pladevall-Vila M , Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A . Post-authorization safety study of hospitalization for acute kidney injury in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting . Drug Saf. 2023 Feb 1;46(2):157-74. doi: 10.1007/s40264-022-01263-3
Danysh HE , Johannes CB , Beachler DC, Layton JB , Ziemiecki R , Arana A , Dinh J, Li L, Calingaert B , Pladevall-Vila M , Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A . Post-authorization safety studies of acute liver injury and severe complications of urinary tract infection in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting . Drug Saf. 2023 Feb 1;46(2):175-93. doi: 10.1007/s40264-022-01262-4
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
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.
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
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.
Arana A . Estudios descriptivos e híbridos . Presented at the VI Encuentro Nacional de Farmacovigilancia y XVI Encuentro Internacional de Farmacovigilancia de las Américas Meeting; October 29, 2019. Bogota, Colombia.
Margulis AV , Fortuny J , Kaye JA, Calingaert B , Reynolds M , Plana E , McQuay LJ, Jan Atsma W, Franks B, de Vogel S, Perez-Gutthann S , Arana A . Proportions of cancer cases in primary care, hospital, and cancer registry data among patients treated for overactive bladder. Letter to editor . Epidemiology. 2019 Mar;30(2):e8-9. doi: 10.1097/EDE.0000000000000953
Gomez A, Arana A , Huerta C, Montero D, Martin E, Comas M, Giner M, Macia MA, Gil M, Morros R, Duarte T. Use of data based on computerized clinical history ('real world data') in pharmaco-epidemiological studies . Presented at the Spanish Agency of Medicines and Health Products-AEMPS; November 20, 2018. Madrid, Spain.
Margulis AV , Linder M, Arana A , Pottegard A, Berglind IA, Bui CL , Kristiansen NS, Bahmanyar S, McQuay LJ, Atsma WJ, Appenteng K, D'Silva M, Perez-Gutthann S , Hallas J. Patterns of use of antimuscarinic drugs to treat overactive bladder in Denmark, Sweden, and the United Kingdom . PLoS One. 2018 Sep 27;13(9):e0204456. doi: 10.1371/journal.pone.0204456
Margulis AV , Fortuny J , Kaye JA, Calingaert B , Reynolds M , Plana E , McQuy LJ, Atsma WJ, Franks B, de Vogel S, Perez-Gutthann S , Arana A . Value of free-text comments for validating cancer cases using primary-care data in the United Kingdom . Epidemiology. 2018 Sep;29(5):e41-2.
Castellsague J, Poblador-Plou B, Giner-Soriano M, Linder M, Scholle O, Calingaert B , Bui C , Arana A , Laguna C, Gonzalez-Rubio F, Roso-Llorach A, Prados-Torres A, Perez-Gutthann S . Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany . Pharmacoepidemiol Drug Saf. 2018 Sep;27(9):953-61. doi: 10.1002/pds.4584
Arana A , Margulis AV , McQuay LJ, Ziemiecki R , Bartsch JL , Rothman KJ , Franks B, D Silva M, Appenteng K, Varas-Lorenzo C, Perez-Gutthann S . Variation in cardiovascular risk related to individual antimuscarinic drugs used to treat overactive bladder: a cohort study in the UK . Pharmacotherapy. 2018 Jun;38(6):628-37. doi: 10.1002/phar.2121.
Margulis AV , Fortuny J , Kaye JA, Calingaert B , Reynolds M , Plana E , McQuay LJ, Atsma WJ, Franks B, de Vogel S, Perez-Gutthann S , Arana A . Validation of cancer cases using primary care, cancer registry, and hospitalization data in the UK . Epidemiology. 2018 Mar;29(2):308-13. doi: 10.1097/EDE.0000000000000786
Arana A , Huerta C, Prieto D, Montero D, Hermosilla E, Martin E, Mendez L, del Mar Garcia M, Comas M, Giner M, Macia MA, Morros R, Duarte T. Uso de datos basados en historia clinica informatizada ('real world data') en los estudios farmaco-epidemiologicos . Presented at en IDIAP Jordi Gol Conference; October 23, 2017. Barcelona, Spain.
Castellsague J, Perez-Gutthann S , Calingaert B , Bui C , Varas-Lorenzo C, Arana A , Prados-Torres A, Poblador-Plou B, Gonzalez-Rubio F, Giner-Soriano M, Roso-Llorach A, Linder M, Citarella A, Scholle O, Blenk T, Garbe E. Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany . Pharmacoepidemiol Drug Saf. 2017 Jun;26(6):615-24. doi: 10.1002/pds.4167
Arana A . The ENCePP methods guide . Presented at the Joint DIA/EMA Information Day on Post-Authorisation Studies (PAS); June 5, 2015. London, United Kingdom.
Arana A , Allen S, Burkowitz J, Fantoni V, Ghatnekar O, Rico MT, Vanhaverbeke N, Wentworth CE, Brosa M, Arellano FM. Infliximab paediatric Crohn's disease educational plan: a European, cross-sectional, multicentre evaluation . Drug Saf. 2010 Jun;33(6):489-501.