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Abtahi S, Pajouheshnia R, Duran CE, Riera-Arnau J, Gamba M, Alsina E, Hoxhaj V, Andersen M, Bartolini C, Kristiansen SB, Brown J, Hallgreen CE, Garcia-Poza P, Gardarsdottir H, Gini R, Girardi A, Holthuis E, Huerta C, Ibanez L, Limoncella G, Martin-Perez M, Paoletti O, Roberto G, Souverein P, Swart KMA, Wing K, Sturkenboom M, Klungel O. Impact of 2018 EU Risk minimisation measures and revised pregnancy prevention programme on utilisation and prescribing trends of medicinal products containing valproate: an interrupted time series study. Drug Saf. 2023 Jul;46(7):689-702. doi: 10.1007/s40264-023-01314-3
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
Abtahi S, Pajouheshnia R, Duran-Salinas C, Riera-Arnau J, Gamba M, Alsina E, Hallgreen CE, Limoncella G, Bartolini C, Holthuis E, Martin-Perez M, Brown J, Sturkenboom M, Klungel O, Other Lot Consortium Members of the Valproate study. Impact of 2018 EU risk minimisation measures and revised pregnancy prevention programme on utilisation and prescribing trends of valproates. Poster presented at the 21st International Society of Pharmacovigilance (ISoP) Annual Meeting 2022; September 20, 2022. Verona, Italy. [abstract] Drug Saf. 2022 Aug 29; 45:1312-3. doi: 10.1007/s40264-022-01219-7
Abtahi S, Pajouheshnia R, Duran-Salinas C, Riera-Arnau J, Gamba M, Alsina E, Hallgreen CE, Limoncella G, Bartolini C, Martin-Perez M, Brown J, Sturkenboom M, Klungel O, Other Lot4 Consortium Members of the Valproate study1. Impact of the 2018 pregnancy prevention program on the use of oral retinoids in childbearing age females in Europe. Presented at the 21st International Society of Pharmacovigilance (ISoP) Annual Meeting 2022; September 20, 2022. Verona, Italy. [abstract] Drug Saf. 2022 Aug 29; 45:1111-327. doi: 10.1007/s40264-022-01219-7
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
Ersbøll AK, Sengupta K, Pukkala E, Bolin K, Aas E, Emneus M, Ramey DR, Brady JE, Mines D, Aasbjerg K, Vestergaard C, Gislason G, Born AP, Kjærulff TM. Desloratadine exposure and incidence of seizure: a nordic post-authorization safety study using a new-user cohort study design, 2001-2015. Drug Saf. 2021 Nov;44(11):1231-42. doi: 10.1007/s40264-021-01106-7
Doward L, Twiss J, Breckons M, Balp MM, Pettersson B, McSweeney L, Oluboyede Y, Vale L, Brass C, Anstee QM, Sanyal AJ. Evaluation of the NASH-CHECK patient-reported outcome instrument for patients with nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. Poster presented at the AASLD Liver Meeting; November 12, 2021. Anaheim, CA. [abstract] Hepatology. 2021 Oct 1; 74(S1):1007A. doi: 10.1002/hep.32188
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
Whalley D, Twiss J, Doward L, Balp MM, Brass C, Tietz A, Loeffler J, Lopez P, Lawitz EJ, Sanyal AJ. A novel patient-reported outcome measure indicates low burden of treatment among patients with non-alcoholic steatohepatitis: interim results from a phase 2 trial of tropifexor. Poster presented at the AASLD 2020 annual meeting; November 13, 2020. Boston, MA. [abstract] Hepatology. 2020 Oct 1; 72(S1):1005A. doi: 10.1002/hep.31579
Doward L, Twiss J, Whalley D, Balp MM, Brass C, Loeffler J, Cryer DR, Cai J, Lopez P, Lawitz EJ, Anstee QM, Sanyal AJ. Development of NASH-CHECK: a new patient-reported outcome measure for NASH. Poster presented at the AASLD 2020 annual meeting; November 13, 2020. Boston, MA. [abstract] Hepatology. 2020 Oct 1; 72(S1):1014A-5A. doi: 10.1002/hep.31579
Gilsenan A, Fortuny J, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Harding A, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu E, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Cardiovascular safety of prucalopride in patients with chronic constipation: a multinational population-based cohort study. Drug Saf. 2019 Oct;42(10):1179-90. doi: 10.1007/s40264-019-00835-0
Fortuny J, Gilsenan A, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Study design and cohort comparability in a study of major cardiovascular events in new users of prucalopride versus polyethylene glycol 3350. Drug Saf. 2019 Oct;47(10):1167-77. doi: 10.1007/s40264-019-00836-z
Doward LC, Balp M-M, Twiss J, Slota C, Cryer D, Langford A, Collen R, Agashivala N, Brass CA, Anstee QM, Sanyal AJ. Understanding the patient-perceived impact of nonalcoholic steatohepatitis: raising the volume on a silent disease. Poster presented at the 2017 AASLD Liver Meeting; October 23, 2017. Washington, DC. [abstract] Hepatology. 2017 Jul; 66(1 Suppl):1182A.
Gulmez SE, Larrey D, Pageaux GP, Lignot S, Lassalle R, Jove J, Gatta A, McCormick A, Metselaar HJ, Monteiro E, Thorburn D, Bernal W, Zouboulis-Vafiadis I, de Vries C, Perez-Gutthann S, Sturkenboom M, Benichou J, Montastruc JL, Horsmans Y, Salvo F, Hamoud F, Micon S, Droz-Perroteau C, Blin P, Moore N. Transplantation for acute liver failure in patients exposed to NSAIDs or Paracetamol (acetaminophen): the multinational case-population SALT study. Drug Saf. 2013 Feb 1;36(2):135-44.
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.