| アブストラクト | INTRODUCTION: At the time of dapagliflozin's approval in Europe (2012) to treat patients with type 2 diabetes mellitus, concerns regarding acute liver injury and severe complications of urinary tract infection (sUTI) led to two post-authorization safety (PAS) studies of these outcomes to monitor the safety of dapagliflozin in real-world use. OBJECTIVE: To investigate the incidence of hospitalization for acute liver injury (hALI) or sUTI (pyelonephritis or urosepsis) among patients initiating dapagliflozin compared with other glucose-lowering drugs (GLDs). METHODS: These two noninterventional cohort studies identified initiators of dapagliflozin and comparator GLDs in November 2012-February 2019 using data from three longitudinal, population-based data sources: Clinical Practice Research Datalink (UK), the HealthCore Integrated Research Database (USA), and the Medicare database (USA). Outcomes (hALI and sUTI) were identified with electronic algorithms. Incidence rates were estimated by exposure group. Incidence rate ratios (IRRs) were calculated comparing dapagliflozin to comparator GLDs, using propensity score trimming and stratification to address confounding. The sUTI analyses were conducted separately by sex. RESULTS: In all data sources, hALI and sUTI incidence rates were generally lower in dapagliflozin initiators than comparator GLD initiators. The adjusted IRR (95% confidence interval) pooled across data sources for hALI was 0.85 (0.59-1.24) and for sUTI was 0.76 (0.60-0.96) in females and 0.74 (0.56-1.00) in males. Findings from sensitivity analyses were largely consistent with the primary analyses. CONCLUSIONS: These real-world studies do not suggest increased risks of hALI or sUTI, and they suggest a potential decreased risk of sUTI with dapagliflozin exposure compared with other GLDs. |
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| 投稿者 | Danysh, Heather E; Johannes, Catherine B; Beachler, Daniel C; Layton, J Bradley; Ziemiecki, Ryan; Arana, Alejandro; Dinh, Jade; Li, Ling; Calingaert, Brian; Pladevall-Vila, Manel; Hunt, Phillip R; Chen, Hungta; Karlsson, Cecilia; Johnsson, Kristina; Gilsenan, Alicia |
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| 組織名 | Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, 307;Waverley Oaks Road, Suite 101, Waltham, MA, 02452-8413, USA. hdanysh@rti.org.;Waverley Oaks Road, Suite 101, Waltham, MA, 02452-8413, USA.;Department of Safety and Epidemiology, HealthCore, Inc., Wilmington, DE, USA.;Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions,;Research Triangle Park, NC, USA.;Department of Biostatistics, RTI Health Solutions, Research Triangle Park, NC,;USA.;Barcelona, Spain.;Department of Research Operations, HealthCore, Inc., Wilmington, DE, USA.;The Center for Health Policy and Health Services Research, Henry Ford Health;System, Detroit, MI, USA.;BioPharmaceuticals Business Unit, AstraZeneca, Gaithersburg, MD, USA.;BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. |
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