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.

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Title: 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.
Authors: Danysh HE; Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, 307 Waverley Oaks Road, Suite 101, Waltham, MA, 02452-8413, USA. hdanysh@rti.org., Johannes CB; Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, 307 Waverley Oaks Road, Suite 101, Waltham, MA, 02452-8413, USA., Beachler DC; Department of Safety and Epidemiology, HealthCore, Inc., Wilmington, DE, USA., Layton JB; Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USA., Ziemiecki R; Department of Biostatistics, RTI Health Solutions, Research Triangle Park, NC, USA., Arana A; Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, Barcelona, Spain., Dinh J; Department of Research Operations, HealthCore, Inc., Wilmington, DE, USA., Li L; Department of Safety and Epidemiology, HealthCore, Inc., Wilmington, DE, USA., Calingaert B; Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USA., Pladevall-Vila M; Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, Barcelona, Spain.; The Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, MI, USA., Hunt PR; BioPharmaceuticals Business Unit, AstraZeneca, Gaithersburg, MD, USA., Chen H; BioPharmaceuticals Business Unit, AstraZeneca, Gaithersburg, MD, USA., Karlsson C; BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Johnsson K; BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Gilsenan A; Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USA.
Source: Drug safety [Drug Saf] 2023 Feb; Vol. 46 (2), pp. 175-193. Date of Electronic Publication: 2022 Dec 30.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9002928 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1942 (Electronic) Linking ISSN: 01145916 NLM ISO Abbreviation: Drug Saf Subsets: MEDLINE
Database: MEDLINE Ultimate
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ISSN:1179-1942
DOI:10.1007/s40264-022-01262-4