Xiao-Xiao Li1,2, Yin-Chu Cheng1,3, Suo-di Zhai1,2, Peng Yao2, Si-Yan Zhan3,4, Lu-Wen Shi2. 1. Department of Pharmacy, Peking University Third Hospital, Beijing, China. 2. Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China. 3. Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, China. 4. Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.
Abstract
Aims: To determine the risk of liver injury associated with the use of different intravenous lipid emulsions (LEs) in large populations in a real-world setting in China. Methods: A prescription sequence symmetry analysis was performed using data from 2015 Chinese Basic Health Insurance for Urban Employees. Patients newly prescribed both intravenous LEs and hepatic protectors within time windows of 7, 14, 28, 42, and 60 days of each other were included. The washout period was set to one month according to the waiting-time distribution. After adjusting prescribing time trends, we quantify the deviation from symmetry of patients initiating LEs first and those initiating hepatic protectors first, by calculating adjusted sequence ratios (ASRs) and relevant 95% confidence intervals. Analyses were further stratified by age, gender, and different generations of LEs developed. Results: In total, 416, 997, 1,697, 2,072, and 2,342 patients filled their first prescriptions with both drugs within 7, 14, 28, 42, and 60 days, respectively. Significantly increased risks of liver injury were found across all time windows, and the strongest effect was observed in the first 2 weeks [ASR 6.97 (5.77-8.42) ∼ 7.87 (6.04-10.61)] in overall patients. In subgroup analyses, female gender, age more than 60 years, and soybean oil-based and alternative-LEs showed higher ASRs in almost all time windows. Specially, a lower risk for liver injury was observed in the first 14 days following FO-LEs administration (ASR, 3.42; 95% CI, 0.81-14.47), but the risk started to rise in longer time windows. Conclusion: A strong association was found between LEs use and liver injury through prescription sequence symmetry analysis in a real-world setting, which aligns with trial evidence and clinical experience. Differences revealed in the risks of liver injury among various LEs need further evaluation.
Aims: To determine the risk of liver injury associated with the use of different intravenous lipid emulsions (LEs) in large populations in a real-world setting in China. Methods: A prescription sequence symmetry analysis was performed using data from 2015 Chinese Basic Health Insurance for Urban Employees. Patients newly prescribed both intravenous LEs and hepatic protectors within time windows of 7, 14, 28, 42, and 60 days of each other were included. The washout period was set to one month according to the waiting-time distribution. After adjusting prescribing time trends, we quantify the deviation from symmetry of patients initiating LEs first and those initiating hepatic protectors first, by calculating adjusted sequence ratios (ASRs) and relevant 95% confidence intervals. Analyses were further stratified by age, gender, and different generations of LEs developed. Results: In total, 416, 997, 1,697, 2,072, and 2,342 patients filled their first prescriptions with both drugs within 7, 14, 28, 42, and 60 days, respectively. Significantly increased risks of liver injury were found across all time windows, and the strongest effect was observed in the first 2 weeks [ASR 6.97 (5.77-8.42) ∼ 7.87 (6.04-10.61)] in overall patients. In subgroup analyses, female gender, age more than 60 years, and soybean oil-based and alternative-LEs showed higher ASRs in almost all time windows. Specially, a lower risk for liver injury was observed in the first 14 days following FO-LEs administration (ASR, 3.42; 95% CI, 0.81-14.47), but the risk started to rise in longer time windows. Conclusion: A strong association was found between LEs use and liver injury through prescription sequence symmetry analysis in a real-world setting, which aligns with trial evidence and clinical experience. Differences revealed in the risks of liver injury among various LEs need further evaluation.
Authors: Sruthi Adimadhyam; Glen T Schumock; Gregory S Calip; Daphne E Smith Marsh; Brian T Layden; Todd A Lee Journal: Br J Clin Pharmacol Date: 2018-11-08 Impact factor: 4.335
Authors: Meredith A Baker; Bennet S Cho; Lorenzo Anez-Bustillos; Duy T Dao; Amy Pan; Alison A O'Loughlin; Zachary M Lans; Paul D Mitchell; Vania Nosé; Kathleen M Gura; Mark Puder; Gillian L Fell Journal: Am J Clin Nutr Date: 2019-04-01 Impact factor: 7.045
Authors: Orly L Levit; Kara L Calkins; L Caroline Gibson; Lorraine Kelley-Quon; Daniel T Robinson; David A Elashoff; Tristan R Grogan; Ning Li; Matthew J Bizzarro; Richard A Ehrenkranz Journal: JPEN J Parenter Enteral Nutr Date: 2014-06-24 Impact factor: 4.016
Authors: Karim C El Kasmi; Aimee L Anderson; Michael W Devereaux; Padade M Vue; Wujuan Zhang; Kenneth D R Setchell; Saul J Karpen; Ronald J Sokol Journal: Sci Transl Med Date: 2013-10-09 Impact factor: 17.956
Authors: Nicole Pratt; Esther W Chan; Nam-Kyong Choi; Michio Kimura; Tomomi Kimura; Kiyoshi Kubota; Edward Chia-Cheng Lai; Kenneth K C Man; Nobuhiro Ooba; Byung-Joo Park; Tsugumichi Sato; Ju-Young Shin; Ian C K Wong; Yea-Huei Kao Yang; Elizabeth E Roughead Journal: Pharmacoepidemiol Drug Saf Date: 2015-04-22 Impact factor: 2.890
Authors: Rebecca Davies; Diederik De Cock; Lianne Kearsley-Fleet; Taunton Southwood; Eileen Baildam; Michael W Beresford; Helen E Foster; Wendy Thomson; Athimalaipet V Ramanan; Kimme L Hyrich Journal: Rheumatology (Oxford) Date: 2020-06-01 Impact factor: 7.580