Publications

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Displaying 1 through 50 of 69 publications.

Rao S, McQuay LJ, Forns J, MacKay R, Danysh HE, Doshi D, Abler V, Anthony MS, Layton JB. Evaluation of mortality in users of pimavanserin compared with other atypical antipsychotics in patients with Parkinson's disease psychosis: an update. Drug Saf. 2025 Apr 9. doi: 10.1007/s40264-025-01543-8

Rees K, Takeda A, Court R, Kudrna L, Hartley L, Ernst E. Meditation for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2024 Feb 15;15(2):CD013358. doi: 10.1002/14651858.CD013358.pub2

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

Chomistek AK, Phiri K, Doherty MC, Calderbank JF, Chiuve SE, McIlroy BH, Snabes MC, Enger C, Seeger JD. Correction to: development and validation of ICD‑10‑CM‑based algorithms for date of last menstrual period, pregnancy outcomes, and infant outcomes. Drug Saf. 2023 May;46(5):515. doi: 10.1007/s40264-023-01280-w

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

Chomistek AK, Phiri K, Doherty MC, Calderbank JF, Chiuve SE, McIlroy BH, Snabes MC, Enger C, Seeger JD. Development and validation of ICD-10-CM-based algorithms for date of last menstrual period, pregnancy outcomes, and infant outcomes. Drug Saf. 2023 Feb;46(2):209-22. doi: 10.1007/s40264-022-01261-5

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

Layton JB, Forns Guzman J, McQuay LJ, Danysh HE, Dempsey C, Anthony MS, Turner ME. Mortality in patients with Parkinson's disease-related psychosis treated with pimavanserin compared with other atypical antipsychotics: a cohort study. Drug Saf. 2023 Feb 1;46(2):195-208. doi: 10.1007/s40264-022-01260-6

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

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

Ruigomez A, Plana E, Gilsenan A, Fortuny J, Cainzos-Achirica M, Flynn RWV, MacDonald TM, Garcia-Rodriguez L, Ziemiecki R, Andrews EB. Identification and validation of major cardiovascular events in the United Kingdom data sources included in a multi-database post-authorization safety study of prucalopride. Drug Saf. 2021 May;44(5):541-51. doi: 10.1007/s40264-021-01044-4

Wen X, van der Laan M, Wyss R, Platt RW, Pajouheshnia R, Schneeweiss S. Machine learning to optimize and automate confounding control in studies using high-dimensional healthcare data. Presented at the Virtual 2020 36th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020. [abstract] Drug Saf. 2020 Oct 15; 29(S3):384. doi: 10.1002/pds.5114

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

Nussbaumer-Streit B, Greenblatt A, Kaminski-Hartenthaler A, Van Noord MG, Forneris CA, Morgan LC, Gaynes BN, Wipplinger J, Lux LJ, Winkler D, Gartlehner G. Melatonin and agomelatine for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2019 Jun 17;6(6):CD011271. doi: 10.1002/14651858.CD011271.pub3

Forneris CA, Nussbaumer-Streit B, Morgan LC, Greenblatt A, Van Noord MG, Gaynes BN, Wipplinger J, Lux LJ, Winkler D, Gartlehner G. Psychological therapies for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2019 May 24;5(5):CD011270. doi: 10.1002/14651858.CD011270.pub3

Gartlehner G, Nussbaumer-Streit B, Gaynes BN, Forneris CA, Morgan LC, Greenblatt A, Wipplinger J, Lux LJ, Van Noord MG, Winkler D. Second-generation antidepressants for preventing seasonal affective disorder in adults. Cochrane Database Syst Rev. 2019 Mar 18;3(3):CD011268. doi: 10.1002/14651858.CD011268.pub3

Nussbaumer-Streit B, Forneris CA, Morgan LC, Van Noord MG, Gaynes BN, Greenblatt A, Wipplinger J, Lux LJ, Winkler D, Gartlehner G. Light therapy for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2019 Mar 18;3(3):CD011269. doi: 10.1002/14651858.CD011269.pub3

Rees K, Takeda A, Martin N, Ellis L, Wijesekara D, Vepa A, Das A, Hartley L, Stranges S. Mediterranean‐style diet for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2019 Mar 13;3:CD009825. doi: 10.1002/14651858.CD009825.pub3

Rees K, Takeda A, Martin N, Ellis L, Wijesekara D, Vepa A, Das A, Hartley L, Stranges S. Mediterranean-style diet for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2019 Mar 13;3(3):CD009825. doi: 0.1002/14651858.CD009825.pub3

Warttig S, Alderson P, Evans DJW, Lewis SR, Kourbeti IS, Smith AF. Automated monitoring compared to standard care for the early detection of sepsis in critically ill patients. Cochrane Database Syst Rev. 2018 Jun 25;6(6):CD012404. doi: 10.1002/14651858.CD012404.pub2

Kelly SA, Hartley L, Loveman E, Colquitt JL, Jones HM, Al-Khudairy L, Clar C, Germano R, Lunn HR, Frost G, Rees K. Whole grain cereals for the primary or secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Aug 24;8(8):CD005051. doi: 10.1002/14651858.CD005051.pub3

Clar C, Al-Khudairy L, Loveman E, Kelly SAM, Hartley L, Flowers N, Germano R, Frost G, Rees K. Low glycaemic index diets for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Jul 31;7:CD004467. doi: 10.1002/14651858.CD004467.pub3

Al-Khudairy L, Flowers N, Wheelhouse R, Ghannam O, Hartley L, Stranges S, Rees K. Vitamin C supplementation for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Mar 16;2017(3). doi: 10.1002/14651858.CD011114.pub2

Seeger JD, Bykov K, Bartels DB, Huybrechts K, Schneeweiss S. Propensity score weighting compared to matching in a study of dabigatran and warfarin. Drug Saf. 2017 Feb;40(2):169-81. doi: 10.1007/s40264-016-0480-3

Spoendlin J, Layton JB, Mundkur M, Meier C, Jick SS, Meier CR. The risk of Achilles or biceps tendon rupture in new statin users: a propensity score matched sequential cohort study. Drug Saf. 2016 Dec;39(12):1229-37.

Warttig S, Alderson P, Lewis SR, Smith AF. Intravenous nutrients for preventing inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016 Nov 22;11(11):CD009906. doi: 10.1002/14651858.CD009906.pub2

Arana A, Johannes CB, McQuay LJ, Varas-Lorenzo C, Fife D, Rothman KJ. Risk of out-of-hospital sudden cardiac death in users of domperidone, proton pump inhibitors, or metoclopramide: a population-based nested case-control study. Drug Saf. 2015 Dec;38(12):1187-99. doi: 10.1007/s40264-015-0338-0.

Forneris CA, Nussbaumer B, Kaminski-Hartenthaler A, Morgan LC, Gaynes BN, Sonis JH, Greenblatt A, Wipplinger J, Lux LJ, Winkler D, Van Noord MG, Hofmann J, Gartlehner G. Psychological therapies for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2015 Nov 11;11(11):CV011270. doi: 10.1002/14651858.CD011270.pub2

Kaminski-Hartenthaler A, Nussbaumer B, Forneris CA, Morgan LC, Gaynes BN, Sonis JH, Greenblatt A, Wipplinger J, Lux LJ, Winkler D, Van Noord MG, Hofmann J, Gartlehner G. Melatonin and agomelatine for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2015 Nov 11;11(11):CD011271. doi: 10.1002/14651858.CD011271.pub2

Gartlehner G, Nussbaumer B, Gaynes BN, Forneris CA, Morgan LC, Kaminski-Hartenthaler A, Greenblatt A, Wipplinger J, Lux LJ, Sonis JH, Hofmann J, Van Noord MG, Winkler D. Second-generation antidepressants for preventing seasonal affective disorder in adults. Cochrane Database Syst Rev. 2015 Nov 8;(11):CD1101126. doi: 10.1002/14651858.CD011268.pub2

Nussbaumer B, Kaminski-Hartenthaler A, Forneris CA, Morgan LC, Sonis JH, Gaynes BN, Greenblatt A, Wipplinger J, Lux LJ, Winkler D, Van Noord MG, Hofmann J, Gartlehner G. Light therapy for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2015 Nov 8;(11):CD011269. doi: 10.1002/14651858.CD011269.pub2

Gagne JJ, Polinski JM, Rassen JA, Fischer MA, Seeger JD, Franklin JM, Liu J, Schneeweiss S, Choudhry NK. Selective serotonin reuptake inhibitor use and perioperative bleeding and mortality in patients undergoing coronary artery bypass grafting. Drug Saf. 2015 Nov;38(11):1075-82. doi: 10.1007/s40264-015-0328-2

Martin N, Germano R, Hartley L, Adler AJ, Rees K. Nut consumption for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2015 Sep 28;(9):CD011583. doi: 10.1002/14651858.CD011583.pub2

Hartley L, Clar C, Ghannam O, Flowers N, Stranges S, Rees K. Vitamin K for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2015 Sep 21;(9):CD011148. doi: 10.1002/14651858.CD011148.

Uthman OA, Hartley L, Rees K, Taylor F, Ebrahim S, Clarke A. Multiple risk factor interventions for primary prevention of cardiovascular disease in low- and middle-income countries. Cochrane Database Syst Rev. 2015 Aug 4;(8):CD011163. doi: 10.1002/14651858.CD011163.pub2

Marcano Belisario JS, Jamsek J, Huckvale K, O'Donoghue J, Morrison CP, Car J. Comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods. Cochrane Database Syst Rev. 2015 Jul;27(7):MR000042. doi: 10.1002/14651858.MR000042.pub2

Hartley L, Lee MS, Kwong JSW, Flowers N, Todkill D, Ernst E, Rees K. Qigong for the primary prevention of cardiovascular disease (Review). Cochrane Database Syst Rev. 2015 Jun 11;(6):CD010390.

Kesselheim AS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Seeger JD, Brownstein JS, Woloshin S, Schwartz LM, Toomey T, Dal Pan GJ, Avorn J. Methodological approaches to evaluate the impact of FDA drug safety communications. Drug Saf. 2015 Jun;38(6):565-75. doi: 10.1007/s40264-015-0291-y

Campbell G, Alderson P, Smith AF, Warttig S. Warming of intravenous and irrigation fluids for preventing inadvertent perioperative hypothermia. Cochrane Database Syst Rev. 2015 Apr 13;2015(4):CD009891. doi: 10.1002/14651858.CD009891.pub2

Boardman HM, Hartley L, Eisinga A, Main C, Roque i Figuls M, Bonfill Cosp X, Gabriel Sanchez R, Knight B. Hormone therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database Syst Rev. 2015 Mar 10;3:CD002229. doi: 10.1002/14651858.CD002229

Hartley L, May MD, Rees K. Dietary fibre for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2015;(1):CD011472. doi: 10.1002/14651858.CD011472.pub2

Hartley L, Mavrodaris A, Flowers N, Ernst E, Rees K. Transcendental meditation for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2014 Dec 1;12:CD010359. doi: 10.1002/14651858.CD010359

Warttig S, Alderson P, Campbell G, Smith AF. Interventions for treating inadvertent postoperative hypothermia. Cochrane Database Syst Rev. 2014 Nov 20;11:CD009892. doi: 10.1002/14651858.CD009892.pub2

Alderson P, Campbell G, Smith AF, Warttig S, Nicholson A, Lewis SR. Thermal insulation for preventing inadvertent perioperative hypothermia. Cochrane Database Syst Rev. 2014 Jun 4;6:CD009908. doi: 10.1002/14651858.CD009908.pub2

Hartley L, Dyakova M, Holmes J, Clarke A, Lee MS, Ernst E, Rees K. Yoga for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2014 May 13;5:CD010072.

Hartley L, Flowers N, Lee MS, Ernst E, Rees K. Tai chi for primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2014 Apr 9;4:CD010366. doi: 10.1002/14651858.CD010366