PMID- 27449721 OWN - NLM STAT- MEDLINE DCOM- 20170227 LR - 20210504 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 15 IP - 10 DP - 2016 Oct TI - Update review of the safety of sodium-glucose cotransporter 2 inhibitors for the treatment of patients with type 2 diabetes mellitus. PG - 1401-12 LID - 10.1080/14740338.2016.1216100 [doi] AB - INTRODUCTION: The safety profile of sodium-glucose cotransporter 2 (SGLT2) inhibitors has continued to evolve with the availability of data from clinical trial programs, post-marketing pharmacovigilance and dedicated cardiovascular outcome trials. AREAS COVERED: This article reviews the safety issues associated with the SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin, particularly the newer/emergent safety data related to US Food and Drug Administration statements regarding these three agents. EXPERT OPINION: The safety profile of SGLT2 inhibitors is well defined, and the adverse event profile is largely consistent with their mechanism of action. These well-recognized events include genital mycotic infections and volume-associated adverse events. Serious safety issues detected more recently with SGLT2 inhibitor therapy, such as bone fractures, pyelonephritis, urosepsis, and ketoacidosis, have been uncommon. A robust improvement in cardiovascular outcomes in patients with type 2 diabetes mellitus (T2DM) was recently demonstrated with empagliflozin. Given the glucose-lowering efficacy, low risk of hypoglycemia, and other benefits associated with SGLT2 inhibitor therapy, this class of oral glucose-lowering medication is a valuable addition to treatment options for T2DM, and may play an increasingly prominent therapeutic role as emerging data are revealed. FAU - Carlson, Curt J AU - Carlson CJ AD - a Lloyd L. Gregory School of Pharmacy , Palm Beach Atlantic University , West Palm Beach , FL , USA. FAU - Santamarina, Marile L AU - Santamarina ML AD - a Lloyd L. Gregory School of Pharmacy , Palm Beach Atlantic University , West Palm Beach , FL , USA. LA - eng PT - Journal Article PT - Review DEP - 20160812 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Benzhydryl Compounds) RN - 0 (Blood Glucose) RN - 0 (Glucosides) RN - 0 (Hypoglycemic Agents) RN - 0 (SLC5A2 protein, human) RN - 0 (Sodium-Glucose Transporter 2) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) RN - 0SAC974Z85 (Canagliflozin) RN - 1ULL0QJ8UC (dapagliflozin) RN - HDC1R2M35U (empagliflozin) SB - IM MH - Benzhydryl Compounds/adverse effects/pharmacology/therapeutic use MH - Blood Glucose/drug effects MH - Canagliflozin/adverse effects/pharmacology/therapeutic use MH - Diabetes Mellitus, Type 2/*drug therapy MH - Glucosides/adverse effects/pharmacology/therapeutic use MH - Humans MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/adverse effects/pharmacology/*therapeutic use MH - Sodium-Glucose Transporter 2 MH - *Sodium-Glucose Transporter 2 Inhibitors OTO - NOTNLM OT - Canagliflozin OT - dapagliflozin OT - empagliflozin OT - safety OT - sodium-glucose cotransporter 2 inhibitors OT - tolerability OT - type 2 diabetes mellitus EDAT- 2016/07/28 06:00 MHDA- 2017/02/28 06:00 CRDT- 2016/07/25 06:00 PHST- 2016/07/25 06:00 [entrez] PHST- 2016/07/28 06:00 [pubmed] PHST- 2017/02/28 06:00 [medline] AID - 10.1080/14740338.2016.1216100 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2016 Oct;15(10):1401-12. doi: 10.1080/14740338.2016.1216100. Epub 2016 Aug 12.