Publications

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Displaying 1 through 50 of 99 publications.

Oberprieler NG, Pladevall-Vila M, Johannes C, Layton JB, Golozar A, Lavallee M, Liu F, Kubin M, Vizcaya D. FOUNTAIN: a modular research platform for integrated real-world evidence generation. BMC Med Res Methodol. 2024 Oct 1;24(1):224. doi: 10.1186/s12874-024-02344-w

Johannes CB, Ziemiecki R, Pladevall-Vila M, Kosvesdy CP, Ebert N, Thomsen RWW, Christiansen CF, Baak B, Cabaninas CR, Kashihara N, Yano Y, Kanegae H, Coleman CI, Okami S, Li u F, Layton JB, Vizcaya D, Oberprieler NG. Use of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease: a multicountry report from the FOUNTAIN platform. Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.

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

Oberprieler NG, Kovesdy CP, Layton JB, Gay A, Farjat AE, Liu F, Johannes CB, Pladevall-Vila M, Vizcaya D. Early use and effectiveness of finerenone in US patients with CKD and type 2 diabetes: a FOUNTAIN platform analysis. Poster presented at the Kidney Week 2023; November 2, 2023. Philadelphia, PA.

Tormos A, Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D, Garcia Esteban R, Plana E, Farsani SF, Perez-Gutthann S, Pladevall-Vila M, Rebordosa C. Post-authorisation safety study (PASS) assessing the risk of liver, renal, genitourinary, and diabetic ketoacidosis outcomes among users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes mellitus (T2D). Poster presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):585. doi: 10.1002/pds.5687

Oberprieler NG, Pladevall-Vila M, Johannes CB, Layton JB, Golozar A, Lavallee M, Kubin M, Vizcaya D. FOUNTAIN: a modular research platform for integrated real-world evidence generation. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):243. doi: 10.1002/pds.5687

Thomsen RW, Andersen IT, Kristensen FP, Munch PV, Pladevall-Vila M, Johannes C, Saigi-Morgui N, Ziemiecki R, Layton J, Vizcaya D, Gay A, Farjat A, Liu F, Oberprieler N, Christiansen CF. Clinical profile and kidney function of SGLT2i and GLP-1RA new users with CKD and type 2 diabetes in Denmark: a nationwide population-based study part of the FOUNTAIN platform. Presented at the 59th Annual Meeting European Association for the Study of Diabetes (EASD) 2023; October 4, 2023. Hamburg, Germany.

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

Alexander K, Margulis AV, Foreman PK, Shediac R, Calingaert B, Harding A, Pladevall-Vila M, Landis S. Birth prevalence of phenylalanine hydroxylase deficiency: a systematic literature review and meta-analysis. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.

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.

Foreman PK, Margulis AV, Alexander K, Shediac R, Calingaert B, Harding A, Pladevall-Vila M, Landis S. Birth prevalence of phenylalanine hydroxylase deficiency: a systematic literature review and meta-analysis. Orphanet J Rare Dis. 2021 Jun 3;16(1):253. doi: 10.1186/s13023-021-01874-6

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.

Timmer A, de Sordi D, Kappen S, Kohse KP, Schink T, Perez-Gutthann S, Jacquot E, Deltour N, Pladevall M. Validity of hospital ICD-10-GM codes to identify acute liver injury in Germany. Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1344-52. doi: 10.1002/pds.4855

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

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, Hallas J, Cortes J, Hagg D, Jacquot E, Deltour N, Perez-Gutthann S, Pladevall M, Reutfors J. Antidepressant use in Denmark, Germany, Spain, and Sweden from 2009 to 2014: incidence and comorbidities of antidepressant initiators. 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):560. doi: 10.1002/pds.4864

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

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

Pladevall 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, Kollhorst B, Brandt L, Cortes J, Aguado J, Perlemuter G, Falissard B, Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S. Agomelatine and other antidepressants and the risk of acute liver injury (ALI), a post authorisation safety study (PASS) in four European countries. Poster presented at the 31st ECNP Congress; October 8, 2018. Barcelona, Spain. Previously presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management.

Cainzos-Achirica M, Bilal U, Al Rifai M, McEvoy JW, Blumenthal RS, Kapoor K, Martinez-Sanchez JM, Comin-Colet J, Pladevall-Vila M, Blaha MJ. Communication issues in nutritional observational research. Prev Med. 2018 Oct;115:76-82. doi: 10.1016/j.ypmed.2018.08.024

Pladevall M, Hallas J, Schink T, Reutfors J, Morros R, Poblador-Plou B, Forns J, Hellfritzsch M, Reinders T, Hagg D, Giner-Soriano M, Prados-Torres A, Cainzos-Achirica M, Pottegard A, Kollhorst B, Brandt L, Cortes J, Aguado J, Perlemuter G, Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S. Agomelatine and other antidepressants and the risk of acute liver injury (ALI), a PASS in four European countries. Presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2018. Prague, Czech Republic. doi: 10.1002/pds.4629

Forns J, Cainzos-Achirica M, Hellfritzsch M, Giner-Soriano M, Poblador-Plou B, Hallas J, Morros R, Prados-Torres A, Pottegard A, Cortes J, Aguado J, Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S, Pladevall M. How valid are the codes used to identify acute liver injury (ALI)? A study in 3 European data sources. Presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug 17; 27(S2):371-2. doi: 10.1002/pds.4629

Tormos A, Rebordosa C, Thomas S, Plana E, Rasouliyan L, Pladevall-Vila M, Fazeli-Farsani S, Deruaz-Luyet A, Brodovicz KG, Perez-Gutthann S. Time between laboratory tests and acute liver and kidney injury diagnosis codes in CPRD: are we doing it right? Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):452. doi: 10.1002/pds.4629

Timmer A, Kappen S, de Sordi D, Pladevall M, Perez-Gutthann S, Jacquot E, Deltour N, Schink T. Validity of hospital ICD-10-GM codes to identify acute liver injury. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):262. doi: 10.1002/pds.4629

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

Cainzos-Achirica M, Pladevall-Vila M, Bilal U. Coffee drinking and mortality in 10 European countries - editorial. Ann Intern Med. 2018 Mar 6;168(5):379-80. doi: 10.7326/L17-0687

Cainzos-Achirica M, Bilal U, Kapoor K, Quispe Ayala R, McEvoy JW, Pladevall-Vila M, Blumenthal RS, Blaha MJ. Methodological issues in nutritional epidemiology research–sorting through the confusion. Current Cardiovascular Risk Reports. 2018 Feb;12:4. doi: 10.1007/s12170-018-0567-8

Pladevall M, Hallas J, Schink T, Morros R, Poblador-Plou B, Forns J, Hellfritzsch M, Reinders T, Giner-Soriano M, Prados-Torres A, Cainzos-Achirica M, Pottegard A, Kollhorst B, Cortes J, Aguado J, Perlemuter G, Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S. Agomelatine and risk of hospitalization for acute liver injury: nested case-control study in Spain, Germany, and Denmark. Poster presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 29, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):389. doi: 10.1002/pds

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. Evaluation of potential off-label prescribing of dabigatran etexilate in France, Denmark, and the United Kingdom and associated methodological challenges. Poster presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 30, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):566. doi: 10.1002/pds

Willame C, Rosillon D, Zima J, Angelo MG, Stuurman AL, Vroling H, Boggon R, Bunge EM, Pladevall-Vila M, Baril L. Risk of new onset autoimmune disease in 9- to 25-year-old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom. Hum Vaccin Immunother. 2016 Nov;12(11):2862-71. doi: 10.1080/21645515.2016.1199308

Gange JJ, Lix LM, Pladevall-Vila M, Toh S, Dore DD. Transitioning to ICD-10: international lessons learned and strategies for moving forward. Presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2016. Dublin, Ireland.

Margulis AV, Varas-Lorenzo C, Bui CL, McQuay LJ, Ziemiecki R, Reynolds M, Rebordosa C, Pladevall-Vila M, Fortuny J, Rivero-Ferrer E, Plana E, Atsma WJ, Appenteng K, Franks B, de Vogel S, D'Silva M, Perez-Gutthann S, Arana A. Validation of cardiovascular events and covariates in CPRD GOLD using questionnaires to general practitioners (GPS). Presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):255-6.

Gil M, Romio S, Scotti L, Leal I, Masclee GMC, Schmedt N, Varas-Lorenzo C, Pladevall-Vila M, Smits MM, Bezemer I, Seeger JD, de Beradis G, Pecchioli S, Trifiro G, McGrogan A, Rijnbeek P, Sturkenboom M. Risk of hemorrhagic stroke associated with non-insulin blood glucose lowering drugs. Results from the SAFEGUARD project. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):428-9.

Masclee GMC, Leal I, Scotti L, De Berardis G, Bezemer I, Gil M, McGrogan A, Schmedt N, Seeger JD, Trifiro G, Pecchioli S, Pladevall-Vila M, Smits MM, Rijnbeek P, Sturkenboom M, Romio SA. Use of non-insulin blood glucose lowering drugs and the risk of acute pancreatitis. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):246-7.

Mitchell S, Roso S, Samuel M, Pladevall-Vila M. Unmet need in the hyperlipidaemia population with high risk of cardiovascular disease: a targeted literature review of observational studies. BMC Cardiovasc Disord. 2016 Apr 26;16(1):74. doi: 10.1186/s12872-016-0241-3

Pladevall M, Riera Guardia N, Margulis AV, Varas-Lorenzo C, Calingaert B, Perez-Gutthann S. Cardiovascular risk associated with the use of glitazones, metformin and sufonylureas: meta-analysis of published observational studies. BMC Cardiovasc Disord. 2016 Jan 15;16(1):14. doi: 10.1186/s12872-016-0187-5

Williame C, Rosillon D, Zima J, Angelo MG, Stuurman A, Vroling H, van Staa T, Boggon R, Bunge E, Pladevall-Vila M, Baril L. Risk of autoimmune diseases (AD) after human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine immunization in women aged 9 to 25 years in the United Kingdom: an observational cohort study. Poster presented at the 31st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2015. Boston, MA.

Pladevall M, Divine G, Wells KE, Resnicow K, Williams LK. A randomized controlled trial to provide adherence information and motivational interviewing to improve diabetes and lipid control. Diabetes Educ. 2015 Feb;41(1):136-46.

Mitchell S, Roso S, Samuel M, Woods MS, Pladevall-Vila M. Targeted literature review of unmet need in the hyperlipidaemia population with high risk of cardiovascular disease. Poster presented at the 2014 ISPOR 17th Annual European Congress; November 2014. Amsterdam, The Netherlands.

Margulis AV, Pladevall M, Riera-Guardia N, Varas-Lorenzo C, Hazell L, Berkman ND, Viswanathan M, Perez-Gutthann S. Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle-Ottawa Scale and the RTI item bank. Clin Epidemiol. 2014 Oct 10;6:359-68. doi: 10.2147/CLEP.S66677

Hazell L, Pladevall-Vila M, Scotti L, De Berardis G, Varas-Lorenzo C, Perez-Gutthann S, Sturkenboom M, Shakir S. Diabetes drugs and acute pancreatitis: a systematic review of observational studies. Poster presented at the 30th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; October 2014. [abstract] Pharmacoepidemiol Drug Saf. 2014 Oct; 23(S1):277.

Rosillon D, Willame C, Pladevall-Vila M, Zima J, van den Bosch JH, Bunge E, van Staa T, Boggon R, Baril L. Design and feasibility of a study using the Clinical Practice Research Datalink General Practice OnLine Database (CPRD GOLD) to assess the risk of new onset of auto-immune diseases (NOAD) following administration of the human papillomavirus (HPV)-16/18 AS. Poster presented at the 30th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; October 2014. [abstract] Pharmacoepidemiol Drug Saf. 2014 Oct; 23(S1):277.

Varas-Lorenzo C, Margulis AV, Pladevall M, Riera-Guardia N, Calingaert B, Hazell L, Romio S, Perez-Gutthann S. The risk of heart failure associated with the use of noninsulin blood glucose-lowering drugs: systematic review and meta-analysis of published observational studies. BMC Cardiovasc Disord. 2014 Sep 26;14(1):129. doi: 10.1186/1471-2261-14-129

Varas-Lorenzo C, Riera-Guardia N, Calingaert B, Margulis A, Pladevall M, Miguel G, Romio S, Sturkenboom M, Perez-Gutthann S. Cardiovascular risk with glitazones and metformin: results from a systematic review of observational studies. Poster presented at the 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management; August 2013. [abstract] Pharmacoepidemiol Drug Saf. 2013 Oct 7; 22(S1):68.

Riera Guardia N, Margulis AV, Pladevall-Vila M, Varas-Lorenzo C, Perez-Gutthann S. Methods issues in observational studies of the cardiovascular risk associated with glucose-lowering medications: results of a systematic review and evaluation. Poster presented at the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; October 7, 2013. [abstract] Pharmacoepidemiol Drug Saf. 22(Suppl 1):S80-81.

Pladevall M, Zografos L, Tatt I, Napalkov P, Andrews E, Perez-Gutthann S. Feasibility evaluation for a rituximab utilization study to be conducted in infusion centers. Poster presented at the 29th International Conference on Pharmacoepidemiology; August 2013.

Margulis AV, Pladevall-Vila M, Riera Guardia N, Varas-Lorenzo C, Hazell L, Perez-Gutthann S. Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastele-Ottawa Scale and the RTI Item Bank. Poster presented at the 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management; August 2013.

Pladevall-Vila M, Varas-Lorenzo C, Margulis AV, Riera Guardia N, Calingaert B, Romio S. Rosiglitazone vs. pioglitazone and acute myocardial infarction: systematic review and meta-analysis of observational studies. Presented at the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2013.