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Publications
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
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
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
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, 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.
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
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
Rebordosa C, Aguado J, Plana E, Thomas S, Frances A, Lei A, Garcia-Gil E, Nuevo J, Perez-Gutthann S, Castellsague J. Use of aclidinium did not increase the risk of death in a noninterventional cohort study in the Clinical Practice Research Datalink (CPRD), United Kingdom. Respir Med. 2019 Jun;152:37-43. doi: 10.1016/j.rmed.2019.04.018
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, Hagg D, Hallas J, Cortes J, Jacquot E, Deltour N, Perez-Gutthann S, Pladevall M, Reutfors J. Antidepressant use in Denmark, Germany, Spain, and Sweden between 2009 and 2014: Incidence and comorbidities of antidepressant initiators. J Affect Disord. 2019 Apr 15;249:242-52. doi: 10.1016/j.jad.2019.02.010
Pladevall-Vila M, Pottegard A, Schink T, Reutfors J, Morros R, Poblador-Plou B, Timmer A, Forns J, Hellfritzsch M, Reinders T, Hagg D, Giner-Soriano M, Prados-Torres A, Cainzos-Achirica M, Hallas J, Brandt L, Cortes J, Aguado J, Perlemuter G, Falissard B, Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S. Risk of acute liver injury in agomelatine and other antidepressant users in four European countries: a cohort and nested case-control study using automated health data sources. CNS Drugs. 2019 Apr;33(4):383-95. doi: 10.1007/s40263-019-00611-9
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
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
Cainzos-Achirica M, Rebordosa C, Vela E, Cleries M, Matsushita K, Plana E, Rivero-Ferrer E, Enjuanes C, Jimenez-Marrero S, Garcia-Rodriguez LA, Comin-Colet J, Perez-Gutthann S. Challenges of evaluating chronic heart failure and acute heart failure events in research studies using large health care databases. Am Heart J. 2018 Aug;202:76-83. doi: 10.1016/j.ahj.2018.05.005
Cainzos-Achirica M, Varas-Lorenzo C, Pottegard A, Asmar J, Plana E, Rasmussen L, Bizouard G, Forns J, Hellfritzsch M, Zint K, Perez-Gutthann S, Pladevall-Vila M. Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: a case study of dabigatran etexilate in Europe. Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):713-23. doi: 10.1002/pds.4416
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.
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. Use of topical tacrolimus and topical pimecrolimus in four European countries: a multicentre database cohort study. Drugs Real World Outcomes. 2018 Jun;5(2):109-16. doi: 10.1007/s40801-018-0133-1
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. 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). Clin Epidemiol. 2018 Mar 13;2018(10):299-310. doi: 10.2147/CLEP.S146442
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
MacDonald TM, Hawkey CJ, Ford I, McMurray JJV, Scheiman JM, Hallas J, Findlay E, Grobbee DE, Hobbs FDR, Ralston SH, Reid DM, Walters MR, Webster J, Ruschitzka F, Ritchie SLD, Perez-Gutthann S, Connolly E, Greenlaw N, Wilson A, Wei L, Mackenzie IS. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT). Eur Heart J. 2017 Jun 14;38(23):1843-50. doi: 10.1093/eurheartj/ehw387
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
Kaye JA, Castellsague J, Bui CL, Calingaert B, McQuay LJ, Riera-Guardia N, Saltus CW, Quinlan S, Holick CN, Wahl PM, Suzart K, Rothman KJ, Wallander M-A, Perez-Gutthann S. Risk of acute liver injury associated with the use of moxifloxacin and other oral antimicrobials: a retrospective, population-based cohort study. Pharmacotherapy. 2014 Apr;34(4):336-49. doi: 10.1002/phar.1367
Bui CL, Kaye JA, Castellsague J, Calingaert B, McQuay LJ, Riera-Guardia N, Saltus CW, Quinlan SC, Holick CN, Wahl PM, Suzart K, Rothman KJ, Wallander MA, Perez-Gutthann S. Validation of acute liver injury cases in a population-based cohort study of oral antimicrobial users. Curr Drug Saf. 2014 Mar;9(1):23-8.
Pisa F, Castellsague J, Drigo D, Riera Guardia N, Giangreco M, Rosolen V, Clagnan E, Zanier L, Perez-Gutthann S, Barbone F. Accuracy of ICD-9-CM codes for upper gastrointestinal complications vaired by position and age: a validation study in a cohort of NSAID users in Friuli Venezia Giulia, Italy. Pharmacoepidemiol Drug Saf. 2013 Nov 22;22(11):1195-204. doi: 10.1002/pds.3504
Pisa F, Castellsague J, Drigo D, Riera-Guardia N, Giangreco M, Rosolen V, Clagnan E, Zanier L, Perez-Gutthann S, Barbone F. Accuracy of International Classification of Diseases, 9th Revision, Clinical Modification codes for upper gastrointestinal complications varied by position and age: a validation study in a cohort of nonsteroidal anti-inflammatory drugs users in Friuli Venezia Giulia, Italy. Pharmacoepidemiol Drug Saf. 2013 Aug 20;22(11):1195-204.
Castellsague J, Pisa F, Rosolen V, Drigo D, Riera Guardia N, Giangreco M, Clagnan E, Tosolini F, Zanier L, Barbone F, Perez-Gutthann S. Risk of upper gastrointestinal complications in a cohort of users of nimesulide and other nonsteroidal anti-inflammatory drugs in Friuli Venezia Giulia, Italy. Pharmacoepidemiol Drug Saf. 2013 Apr 22;22(4):365-75.