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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
Casas G, Limeres J, Oristrell G, Gutierrez-Garcia L, Andreini D, Borregan M, Larrañaga-Moreira JM, Lopez-Sainz A, Codina-Solà M, Teixido-Tura G, Sorolla-Romero JA, Fernández-Álvarez P, González-Carrillo J, Guala A, La Mura L, Soler-Fernández R, Sao Avilés A, Santos-Mateo JJ, Marsal JR, Ribera A, de la Pompa JL, Villacorta E, Jiménez-Jáimez J, Ripoll-Vera T, Bayes-Genis A, Garcia-Pinilla JM, Palomino-Doza J, Tiron C, Pontone G, Bogaert J, Aquaro GD, Gimeno-Blanes JR, Zorio E, Garcia-Pavia P, Barriales-Villa R, Evangelista A, Masci PG, Ferreira-González I, Rodríguez-Palomares JF. Clinical risk prediction in patients with left ventricular myocardial noncompaction. J Am Coll Cardiol. 2021 Aug 17;78(7):643-62. doi: 10.1016/j.jacc.2021.06.016
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
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
Paquette M, Riou Franca L, Teutsch C, Diener HC, Lu S, Dubner SJ, Ma CS, Rothman KJ, Zint K, Halperin JL, Huisman MV, Lip GYH, Nieuwlaat R. Persistence with dabigatran therapy at 2 years in patients with atrial fibrillation. J Am Coll Cardiol. 2017 Sep 26;70(13):1573-83. doi: 10.1016/j.jacc.2017.07.793
Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Bartels DB, Lip GY, GLORIA-AF Investigators. The changing landscape for stroke prevention in AF: findings from the GLORIA-AF Registry Phase 2. J Am Coll Cardiol. 2017 Feb 21;69(7):777-85.
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.
Ferreira-Gonzalez I, Marsal JR, Ribera A, Permanyer-Miralda G, Garcia-Del Blanco B, Marti G, Cascant P, Masotti-Centol M, Carrillo X, Mauri J, Batalla N, Larrousse E, Martin E, Serra A, Rumoroso JR, Ruiz-Salmeron R, De La Torre JM, Cequier A, Gomez-Hospital JA, Alfonso F, Martin-Yuste V, Sabate M, Garcia-Dorado D. Double antiplatelet therapy after drug-eluting stent implantation: risk associated with discontinuation within the first year. J Am Coll Cardiol. 2012 Oct 9;60(15):1333-9. doi: 10.1016/j.jacc.2012.04.057
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.