PMID- 28502502 OWN - NLM STAT- MEDLINE DCOM- 20180101 LR - 20210504 IS - 1933-2874 (Print) IS - 1876-4789 (Linking) VI - 11 IP - 2 DP - 2017 Mar-Apr TI - Dapagliflozin in patients with type II diabetes mellitus, with and without elevated triglyceride and reduced high-density lipoprotein cholesterol levels. PG - 450-458.e1 LID - S1933-2874(17)30023-5 [pii] LID - 10.1016/j.jacl.2017.01.018 [doi] AB - BACKGROUND: Dapagliflozin is a selective sodium-glucose cotransporter 2 inhibitor that improves glycemic control in patients with type II diabetes mellitus (T2DM) by reducing renal glucose reabsorption. OBJECTIVE: The aim was to evaluate the lipid effects of dapagliflozin 10 mg or placebo in patients with T2DM with/without baseline elevated triglyceride and reduced high-density lipoprotein (HDL) cholesterol levels. METHODS: This was a post hoc analysis of 10 phase 3, placebo-controlled studies of dapagliflozin 10 mg (N = 2237) or placebo (N = 2164) administered for 24 weeks in patients with T2DM. Patients with elevated triglyceride (>/=150 mg/dL [1.69 mmol/L]) and reduced HDL cholesterol levels (<40 mg/dL [1.04 mmol/L] in men; <50 mg/dL [1.29 mmol/L] in women) were included (group A). The reference group (group B) included patients who did not meet the defined lipid criteria. RESULTS: The effects of dapagliflozin on fasting lipid profiles were generally similar in the 2 lipid groups (ie, groups A and B) and, compared with placebo, were associated with minor increases in non-HDL cholesterol, low-density lipoprotein, and HDL cholesterol levels. The effects on triglyceride levels were inconsistent. The incidence of adverse events (AEs)/serious AEs, and AEs of genital infection, urinary tract infection, volume reduction, renal function, and hypoglycemia were similar in the 2 lipid groups. CONCLUSION: Patients with T2DM treated with dapagliflozin experienced minor changes in lipid levels; the changes were generally similar in the 2 lipid groups. The clinical significance of these changes in lipids is unclear, especially in view of the positive effects of dapagliflozin on other cardiovascular disease risk factors. CI - Copyright (c) 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved. FAU - Bays, Harold E AU - Bays HE AD - Louisville Metabolic and Atherosclerosis Research Center Inc., Louisville, KY, USA. Electronic address: hbaysmd@outlook.com. FAU - Sartipy, Peter AU - Sartipy P AD - Global Medicines Development, CVMD, AstraZeneca, Gothenburg, Sweden; Systems Biology Research Center, School of Bioscience, University of Skovde, Skovde, Sweden. FAU - Xu, John AU - Xu J AD - Biometrics and Information Sciences, AstraZeneca, Gaithersburg, MD, USA. FAU - Sjostrom, Carl David AU - Sjostrom CD AD - Global Medicines Development, CVMD, AstraZeneca, Gothenburg, Sweden. FAU - Underberg, James A AU - Underberg JA AD - Department of Medicine, NYU School of Medicine & NYU Center for Prevention of Cardiovascular Disease, New York, NY, USA. LA - eng PT - Clinical Trial, Phase III PT - Journal Article DEP - 20170210 PL - United States TA - J Clin Lipidol JT - Journal of clinical lipidology JID - 101300157 RN - 0 (Benzhydryl Compounds) RN - 0 (Blood Glucose) RN - 0 (Glucosides) RN - 0 (Hypoglycemic Agents) RN - 0 (Lipoproteins, HDL) RN - 0 (Triglycerides) RN - 1ULL0QJ8UC (dapagliflozin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Benzhydryl Compounds/*pharmacology/therapeutic use MH - Blood Glucose/metabolism MH - Diabetes Mellitus, Type 2/*blood/*drug therapy MH - Female MH - Glucosides/*pharmacology/therapeutic use MH - Humans MH - Hypoglycemic Agents/*pharmacology/therapeutic use MH - Lipoproteins, HDL/*blood MH - Male MH - Middle Aged MH - Triglycerides/*blood MH - Young Adult OTO - NOTNLM OT - Cardiovascular OT - Dapagliflozin OT - Dyslipidemia OT - SGLT2 inhibitors OT - Type II diabetes mellitus EDAT- 2017/05/16 06:00 MHDA- 2018/01/02 06:00 CRDT- 2017/05/16 06:00 PHST- 2016/11/22 00:00 [received] PHST- 2017/01/24 00:00 [revised] PHST- 2017/01/26 00:00 [accepted] PHST- 2017/05/16 06:00 [entrez] PHST- 2017/05/16 06:00 [pubmed] PHST- 2018/01/02 06:00 [medline] AID - S1933-2874(17)30023-5 [pii] AID - 10.1016/j.jacl.2017.01.018 [doi] PST - ppublish SO - J Clin Lipidol. 2017 Mar-Apr;11(2):450-458.e1. doi: 10.1016/j.jacl.2017.01.018. Epub 2017 Feb 10.