Major adverse cardiovascular and limb events in patients with diabetes and concomitant peripheral artery disease treated
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ORIGINAL INVESTIGATION
Cardiovascular Diabetology Open Access
Major adverse cardiovascular and limb events in patients with diabetes and concomitant peripheral artery disease treated with sodium glucose cotransporter 2 inhibitor versus dipeptidyl peptidase‑4 inhibitor Hsin‑Fu Lee1,2,3,4, Shao‑Wei Chen5, Jia‑Rou Liu6, Pei‑Ru Li6, Lung‑Sheng Wu1,2, Shang‑Hung Chang1,2,7, Yung‑Hsin Yeh1,2, Chi‑Tai Kuo1,2, Yi‑Hsin Chan1,2,8* and Lai‑Chu See6,9,10*
Abstract Background: Whether sodium glucose co-transporter 2 inhibitors (SGLT2i) are associated with a lower risk of car‑ diovascular as well as adverse lower limb events in patients with type-2 diabetes mellitus (T2DM) and concomitant peripheral artery disease (PAD) is unclear. We aimed to evaluate the risk of cardiovascular and limb events, and death associated with the use of SGLT2i com‑ pared with dipeptidyl peptidase-4 inhibitors (DPP4i) among a longitudinal and national cohort of patients with T2DM. Methods: In this nationwide retrospective cohort study based on the Taiwan National Health Insurance Research Database, we identified a total of 11,431 and 93,972 consecutive T2DM patients with PAD taking SGLT2i and DPP4i, respectively, from May 1, 2016, to December 31, 2017. We used 1:1 propensity score matching (PSM) to balance covar‑ iates across study groups. Patients were followed from the drug index date until the occurrence of clinical outcomes, death, discontinuation of the index drug, or the end of the study period, whichever occurred first. Results: Overall, 56% and 44% of the patients were treated with dapagliflozin and empagliflozin, respectively. The use of SGLT2i had comparable risks of ischemic stroke and acute myocardial infarction, and was associated with lower risks of congestive heart failure (CHF) [hazard ratio (HR): 0.66; 95% confidence interval (CI) 0.49–0.89; p = 0.0062], lower limb ischemia requiring revascularization (HR: 0.73; 95% CI 0.54–0.98; p = 0.0367) or amputation (HR: 0.43; 95% CI 0.30–0.62; p 99% coverage rate of residents of Taiwan [15]. This study was approved by the Institutional Review Board of Chang Gung Medical Foundation, Taiwan (1048079B and 201801427B0). Informed consent was waived because the original identification number of each patient in the NHIRD had been encrypted and de-identified to protect their privacy. Study cohort
The study identified a total of 3,623,527 patients with T2DM diagnosed using International Classification of Diseases (ninth revision) Clinical Modification (ICD9-CM) codes (250) between January 1, 1998 and December 31, 2015, or ICD-10-CM codes (E10.0, E10.1, E10.9, E11.0, E11.1, and E11.9) between January 1, 2016 and December 31, 2017. To identify patients with T2DM who had diagnoses indicating PAD, patients with PAD were required to fulfill with at least one of the following the diagnoses or treatments, which have been registered using medical records, ICD-9-CM or ICD-10-CM diagnostic codes, or ICD-9/10-CM procedural codes (Additional file 1: Table S1). Among the 452,149 patients with T2DM and concomi
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