BACKGROUND: The renal benefits of sodium-glucose cotransporter-2 inhibitors (SGLT2) are now well established, and these agents are recommended by the American Diabetes Association and Kidney Disease: Improving Global Outcomes guidelines for patients with type 2 diabetes and chronic kidney disease. However, the safety profile of SGLT2 inhibitors in chronic kidney disease is not as clear. We describe the adverse event rates of SGLT2 inhibitors, primarily empagliflozin, in Kaiser Permanente Southern California members with diabetic kidney disease. METHODS: This study was a multicenter retrospective descriptive analysis evaluating Kaiser Permanente Southern California members with type 2 diabetes and chronic kidney disease 1, 2, or 3 who first filled an SGLT2 inhibitor prescription in 2018, with follow-up through 2019. Primary outcomes were event rates of diabetic ketoacidosis, bone fracture, amputation, urinary tract infection, genital mycotic infection, hyperkalemia, and acute kidney injury. Secondary outcomes were mean changes in estimated glomerular filtration rates, serum creatine levels, urine albumin-to-creatinine ratios, and hemoglobin A1c percentages during the follow-up period. RESULTS: Of 213 patients, 39 experienced at least 1 adverse event, for a total of 50 adverse events. Urinary tract infection had the highest incidence (62.1 events/1000 person-years), followed by genital mycotic infection (58.0 events/1000 person-years). Favorable changes were observed during the follow-up period for urine albumin-to-creatinine ratios and hemoglobin A1c percentages, with mean decreases of 81.8 mg/g and 0.7%, respectively. SGLT2 inhibitors were discontinued in 47.4% of patients, with the top reasons including increase in serum creatinine (8%) and urinary or genital side effects (5.6%). CONCLUSION: Although most patients did not experience adverse events, urinary tract infections and genital mycotic infections were more common. Our detection of rates and types of adverse effects replicated most results reported in clinical trials. Discontinuations were largely attributed to reasons other than adverse events.
BACKGROUND: The renal benefits of sodium-glucose cotransporter-2 inhibitors (SGLT2) are now well established, and these agents are recommended by the American Diabetes Association and Kidney Disease: Improving Global Outcomes guidelines for patients with type 2 diabetes and chronic kidney disease. However, the safety profile of SGLT2 inhibitors in chronic kidney disease is not as clear. We describe the adverse event rates of SGLT2 inhibitors, primarily empagliflozin, in Kaiser Permanente Southern California members with diabetic kidney disease. METHODS: This study was a multicenter retrospective descriptive analysis evaluating Kaiser Permanente Southern California members with type 2 diabetes and chronic kidney disease 1, 2, or 3 who first filled an SGLT2 inhibitor prescription in 2018, with follow-up through 2019. Primary outcomes were event rates of diabetic ketoacidosis, bone fracture, amputation, urinary tract infection, genital mycotic infection, hyperkalemia, and acute kidney injury. Secondary outcomes were mean changes in estimated glomerular filtration rates, serum creatine levels, urine albumin-to-creatinine ratios, and hemoglobin A1c percentages during the follow-up period. RESULTS: Of 213 patients, 39 experienced at least 1 adverse event, for a total of 50 adverse events. Urinary tract infection had the highest incidence (62.1 events/1000 person-years), followed by genital mycotic infection (58.0 events/1000 person-years). Favorable changes were observed during the follow-up period for urine albumin-to-creatinine ratios and hemoglobin A1c percentages, with mean decreases of 81.8 mg/g and 0.7%, respectively. SGLT2 inhibitors were discontinued in 47.4% of patients, with the top reasons including increase in serum creatinine (8%) and urinary or genital side effects (5.6%). CONCLUSION: Although most patients did not experience adverse events, urinary tract infections and genital mycotic infections were more common. Our detection of rates and types of adverse effects replicated most results reported in clinical trials. Discontinuations were largely attributed to reasons other than adverse events.
Authors: Bernard Zinman; Christoph Wanner; John M Lachin; David Fitchett; Erich Bluhmki; Stefan Hantel; Michaela Mattheus; Theresa Devins; Odd Erik Johansen; Hans J Woerle; Uli C Broedl; Silvio E Inzucchi Journal: N Engl J Med Date: 2015-09-17 Impact factor: 91.245
Authors: Bruce Neal; Vlado Perkovic; Kenneth W Mahaffey; Dick de Zeeuw; Greg Fulcher; Ngozi Erondu; Wayne Shaw; Gordon Law; Mehul Desai; David R Matthews Journal: N Engl J Med Date: 2017-06-12 Impact factor: 91.245
Authors: Vlado Perkovic; Meg J Jardine; Bruce Neal; Severine Bompoint; Hiddo J L Heerspink; David M Charytan; Robert Edwards; Rajiv Agarwal; George Bakris; Scott Bull; Christopher P Cannon; George Capuano; Pei-Ling Chu; Dick de Zeeuw; Tom Greene; Adeera Levin; Carol Pollock; David C Wheeler; Yshai Yavin; Hong Zhang; Bernard Zinman; Gary Meininger; Barry M Brenner; Kenneth W Mahaffey Journal: N Engl J Med Date: 2019-04-14 Impact factor: 91.245