Efficacy and safety of empagliflozin: a “real-world” experience from Saudi Arabia

Abstract

BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are new agents for treating type 2 diabetes. In addition to the glycemic benefits, these agents provide cardiorenal protection in patients with diabetes and without diabetes. There is consistent evidence that these agents increase the risk of genitourinary infections and dehydration, but randomized controlled trials have not included patients from the Middle East. OBJECTIVES: Determine the efficacy and safety of empagliflozin, specifically whether the genitourinary infection risk differs in our population and whether there is an increased risk of dehydration, ketoacidosis, hypoglycemia, and hospitalization with fasting. DESIGN: Retrospective review of medical records. SETTINGS: Department of medicine at tertiary care center. PATIENTS AND METHODS: We reviewed the electronic records of patients with type 2 diabetes who took empagliflozin from 1 December 2018 to 30 November 2019. We collected safety and efficacy data for 12 months from the initiation of treatment. MAIN OUTCOMES MEASURES: Glycemic and weight loss efficacy, risk of hospitalization due to hypoglycemia, dehydration, and genitourinary infections. SAMPLE SIZE: 637 patients. RESULTS: We observed an improvement in glycated hemoglobin, a 4.2% weight loss, improved left ventricular function, stable serum creatinine, and reduced albuminuria. Our patients did not have an increased risk of genitourinary infections, hypoglycemia, dehydration, ketoacidosis, or hospitalizations. Fasting did not increase the incidence of adverse events. CONCLUSIONS: Empagliflozin is safe and effective in our local population. We hypothesize that glycosuria induced by empagliflozin is not the sole contributor to the increased risk of genitourinary infections. Local hygiene and circumcision might reduce this risk. Empagliflozin can be used safely during fasting. LIMITATIONS: Retrospective design. CONFLICT OF INTEREST: None.

Impact of sodium-glucose cotransporter-2 inhibitors on kidney outcomes in type 2 diabetes: A tertiary center experience

“…In keeping with previous reports from Saudi Arabia,[ 25 ] the present study showed a slightly reduced MAP after initiating SGLT2 inhibitors. Some international studies have similarly reported a reduction in arterial pressure (AP) after treatment with SGLT2 inhibitors.…”

“…In line with previous reports from Saudi Arabia,[ 25 ] our study demonstrated that SGLT2 inhibitors resulted in a better control of type 2 DM in Saudi patients. However, the study also confirms the antihyperglycemic effect of a different SGLT2 inhibitor in Saudis with type 2 DM.…”

“…[ 28 , 29 ] For example, Cherney et al ., in their EMPA-REG OUTCOME trial, reported that ACR was significantly reduced after the empagliflozin treatment in patients with DN. [ 28 ] Although the proteinuria-lowering effect of empagliflozin in Saudis with type 2 DM was recently demonstrated by Butt et al .,[ 25 ] our study further confirms the anti-proteinuric effect of SGLT2 inhibitors and extends the benefit to a different SGLT2 inhibitor, dapagliflozin. The class effect of SGLT2 inhibitors as anti-proteinuria was demonstrated by a study which showed that six different SGLT2 inhibitors resulted in a similar and significant reduction of ACR.…”

“…[ 23 , 24 ] However, data on the impact of this class of medications in the Arab population, especially in Saudi Arabia, are limited. [ 25 ] Our present study is the second largest to demonstrate the significant improvement of glycemic control, preserved kidney function, and the lowering of the degree of proteinuria in type 2 DM Saudi patients with the use of SGLT2 inhibitors without a significant increase in adverse events.…”

“…In accordance with our findings, previous reports from Saudi Arabia found no significant increase in the rate of UTIs following initiation of SGLT2 inhibitors. [ 25 ] It is unclear if this was related to the culture of hygiene and circumcision or just because we included a relatively healthy uncomplicated population, as evidenced by the low burden of comorbidities and relatively well-preserved kidney function.…”