Publications

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Displaying 1 through 50 of 157 publications.

Arana A, Ehrenstein V, Guo Y, Ryan P. Should confounding control be based on subject-matter knowledge, or driven by the data? A debate. Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.

Weibel D, de Luise C, Cid Royo A, Ryan O, Vaz T, Aguado J, Marsal J, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Pala E, Poblador-Plou B, Gimeno-Miguel A, Santos-Mejias A, Marconi E, Barbieri E, Stona L, Lysen T, Roy D, Hyeraci G, Girardi A, Lupattelli A, Desalegn AA, Villalobos F, Bissacco CA, Kendrick K, Garg R, Rubino H, Sturkenboom MCJM, Arana A. Interim results from the VAC4EU Post-Authorization Safety Study (PASS) among recipients of the Pfizer-BioNTech COVID-19 (Comirnaty®) vaccine in Europe. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.

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

Weibel D, de Luise C, Elbers R, van den Bor R, Martin I, Cid-Royo A, Plana E, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Poblador-Plou B, Marconi E, Barbieri E, Stona L, Swart KMA, Roy D, Hyeraci G, Bartolini C, Lupattelli A, Villalobos F, Kendrick K, Garg R, Rubino H, Eijkemans R, Sturkenboom M, Arana A. Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):173-4. doi: 10.1002/pds.5687

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

Ysander M, Caplanusi I, Arana A. True adverse reaction or not: that's the question. Presented at the Global Forum for Qualified Persons for Pharmacovigilance; November 9, 2022. Amsterdam, Netherlands.

Weibel D, Sturkenboom M, Eijkemans R, van den Bor R, Elbers R, Plana E, Garcia de Albeniz X, Weinrib R, Yefimenko N, Bianchini E, Stona L, Poblador-Plou B, Swart-Polinder K, Bartolini C, Hyeraci RG, Roy D, Lupattelli A, Villalobos F, Barbieri E, Garg RK, Rubino H, de Luise C, Arana A. VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in five European countries: study design and first results. Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8. doi: 10.1002/pds.5518

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

Perez-Gutthann S, Arana A, Margulis A. ENCePP guide on methodological standards in pharmacoepidemiology, 10th edition. 2022.

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

Hellwig K, Magyari M, McDonald T, Gembert K, Wergeland S, Leinonen MK, Aydemir A, Sabido M, Kawai A, Arana A. A multi-country cohort database study to assess pregnancy and infant outcomes in women exposed to cladribine tablets: CLEAR study. Poster presented at the 2021 Digital 37th Conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); October 13, 2021.

Margulis AV, Arana A. Improving the quality of observational data: registries of validated outcomes and other patient events. Epidemiology. 2021 Sep 1;32(5):661-3. doi: 10.1097/EDE.0000000000001392

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.

Danysh HE, Gilsenan A, Arana A, Pladevall-Vila M, Layton JB, Ziemiecki R, Chen H, Hunt PR, Johannes C. Validation of acute outcomes among patients with type 2 diabetes mellitus in the clinical practice research datalink. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.

Arana A. Using emotional intelligence to drive results. Presented at the Virtual ICPE 2021 Conference; August 5, 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

Perez-Gutthann S, Arana A. ENCePP guide on methodological standards in pharmacoepidemiology, 9th edition. 2021.

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

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.

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.

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.

Dinh J, Danysh HE, Johannes C, Gutierrez L, Schmid R, Arana A, Kaye JA, Pladevall-Vila M, Garcia de Albeniz X, Hunt PR, Gilsenan A, Beachler DC, Ke Zhou C. Description of acute kidney injury and breast cancer outcome validation processes across three databases. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

Danysh HE, Layton B, Beachler DC, Arana A, Pladevall-Vila M, Schmid R, Calingaert B, Ziemiecki R, Hunt PR, Gilsenan A, Johannes C. Validation of acute outcomes among patients with type 2 diabetes mellitus in Medicare: a pilot study. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 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.

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

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.

Arana A, Arias A, Salas M. Bases de datos para estudios farmacoepidemiológicos. Presented at the VI Encuentro Nacional de Farmacovigilancia y XVI Encuentro Internacional de Farmacovigilancia de las Américas Meeting; October 29, 2019. Bogota, Colombia.

Arana A, Salas M. Implementacion de las medidas de minimizacion de riesgo. Poster presented at the 19th International Society of Pharmacovigilance Annual Meeting; October 28, 2019. Bogota, Colombia.

Arana A. ENCePP. La red Europea de Centros en Farmacoepidemiología y Farmacovigilancia. Ensayos clínicos poblacionales. Presented at the IDIAP Jordi Gol Conference; October 23, 2019. Barcelona, Spain.

Arana A. Diseños farmacoepidemiológicos avanzados: case-series, case cross-over. Presented at the IDIAP Jordi Gol Conference; October 22, 2019. Barcelona, Spain.

Zhou CK, Dinh J, Danysh HE, Johannes C, Gutierrez L, Schmid R, Arana A, Kaye JA, Pladevall-Vila M, Garcia-Albeniz X, Gangemi K, Yin R, Ruzafa JC, Gilsenan A, Beachler DC. Validity of claims-based algorithms to identify acute kidney injury, acute liver injury, severe complications of urinary tract infections, breast cancer, and bladder cancer among patients with type 2 diabetes: a pilot study. 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):317. doi: 10.1002/pds.4864

Gutierrez L, Booth H, Dedman D, Crellin E, Kaye JA, Franzoni C, Arana A, Schmitt-Egenolf M, Sundstrom A, Bystrom C. Case validation of cutaneous lymphoma to minimize protopathic bias. 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):645. doi: 10.1002/pds.4864

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

Arana A, Perez-Gutthann S, Franzoni C, Gutierrez L. Guidelines for good pharmacoepidemiology practices. Presented at the First European Training Programme in Pharmacovigilance and Pharmacoepidemiology (EU2P); February 2019.

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.

Arana A, Perez-Gutthann S. Therapeutic risk management. Establishing and ensuring the safety of medicines. Presented at the University of Aveiro; October 18, 2018. Aveiro, Portugal.

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, Kurz X, Perez-Gutthann S, Yates L, Trifiro G, Schneeweis S, Verpillat P, Vlcek J. Ten years of ENCePP. Time to celebrate and move forward. Presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2018. Prague, Czech Republic.

Arana A. ENCePP Guide on methodological standards in pharmacoepidemiology, revision 7. 2018.

Arana A, Fourrier-Reglat A, Toussi M. Prospective Studies. In: Ayad K. Ali, Abraham G. Hartzema, editors. Post-authorization safety studies of medicinal products. 1st ed. Cambridge: United States. Academic Press; 2018.

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.

Hallas J, Margulis AV, Pottegard A, Kristiansen NS, Atsma WJ, Appenteng K, de Vogel S, Kaye JA, Perez-Gutthann S, Arana A. Incidence of common cancers in users of antimuscarinic medications for overactive bladder: a Danish nationwide cohort study. Basic Clin Pharmacol Toxicol. 2018 Jun;122(6):612-9. doi: 10.1111/bcpt.12965

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