Effectiveness and Safety of SGLT2 Inhibitors in Clinical Routine Treatment of Patients with Diabetes Mellitus Type 2

Abstract

The aim of this study was to investigate the effectiveness of SGLT2 inhibitors with regard to metabolic parameters and patient safety under routine ambulatory conditions. Retrospective longitudinal study of 95 patients with type 2 diabetes (diabetes duration 13.3 y; HbA1c 8.9%; eGFR 80.1 mL/min) receiving SGLT-2-inhibitors. Metabolic control and adverse event profile were evaluated. The mean follow-up time was 1.2 ± 0.8 years. The following changes were observed: HbA1c −1.0% ± 1.9 (p < 0.001), eGFR −7.0 mL/min ± 13.3 (p < 0.001), albuminuria −23.9 mg/g creatinine ± 144.5 (p = 0.118), bodyweight −3.0 kg ± 5.8 (p < 0.001), systolic blood pressure −6 mmHg ± 22 (p = 0.01), diastolic blood pressure −2 mmHg ± 14 (p = 0.243). 53 participants continuously applied the therapy. Twenty-eight participants discontinued SGLT-2-inhibitors due to various reasons: 20 participants because of genital- or urinary tract infections. One for dysuria, seven due to reduced eGFR below 45 mL/min. This study showed a considerable reduction of HbA1c and a modest reduction of eGFR, bodyweight and systolic blood pressure under clinical routine conditions. Genital infections occurred markedly more often than in randomized controlled trials. To apply SGLT-2-inhibitors more safely in clinical routine individual risks for genital and urinary tract infections should be considered and re-evaluated during therapy.

Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) as a Primary Preventative Agent in the Healthy Individual: A Need of a Future Randomised Clinical Trial?

“…( 19 , 20 ) The rates of DKA in major trials were 0.1–0.5% over 4–8 years ( 19 – 21 ), in concert with a large Australian observational study showing an incidence of 0.1% over 26 months ( 22 ). In comparison to non-SGLT2i antihyperglycemic medications, there was no statistically significant increase of risk in SGLT2i use for type 2 diabetic patients ( 23 ). The US Food and Drug Administration (FDA) and European Medicines Association (EMA) respectively issued drug safety reports on DKA risk in SGLT2i patients with DKA-like symptoms at health services ( 3 ).…”

Effektive antidiabetische Therapie zur Vorbeugung einer diabetischen Nephropathie

“…In einer Untersuchung von Routinedaten trat bei 21,1 % der Studienteilnehmer eine Genitalinfektion bzw. eine Harnwegsinfektion auf, die zum Therapieabbruch führte [38]. Aus diesem Grund ist eine adäquate Aufklärung der Patienten über die entsprechenden Hygienemaßnahmen zwingend notwendig.…”