Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitors and The Risk of Diabetic Ketoacidosis: An Example of Complementary Evidence for Rare Adverse Events

In this study, we conducted a systematic review and meta-analyzed data from RCTs (n=18) and observational (n=7) studies separately, to assess the consistency of the magnitude of association between SGLT-2 inhibitors and DKA. We also illustrate the strengths and weakness of the two designs. Results from RCTs and observational studies consistently show almost a doubling in the risk of DKA in patients using an SGLT-2 inhibitor compared to placebo or active comparator. Using a random-effects model, the pooled relative risk [RR], (95% confidence interval [CI]) was 2.08, (95%CI 1.28, 3.40) from placebo-controlled RCTs and was 0.82 (95%CI 0.25, 2.68) from active-comparator RCTs. The pooled adjusted hazard ratio from observational studies was 1.74, (95%CI 1.28, 2.38). Notably, the two designs complement each other in several domains, including external and internal validity and power. This demonstrates the need for both sources for a more comprehensive evidence when assessing rare adverse events.PMID:33751032 | DOI:10.1093/aje/kwab052
Source: Am J Epidemiol - Category: Epidemiology Authors: Source Type: research