Background SGLT-2 inhibitors, prescribed for type 2 diabetes, have a
heightened risk of amputation. The FDA issued a warning in May 2017, leading to
the inclusion of a cautionary label. Vigilance is essential for patients and
healthcare providers to promptly identify and address potential limb
complications associated with the use of SGLT-2 inhibitors.
Method A comprehensive search of electronic databases was conducted,
covering the period from inception to May 2024. This systematic literature
review adhered to the Preferred Reporting Items for Systematic Reviews and
Meta-Analyses (PRISMA) guidelines. The quality of the included studies was
assessed using the Cochrane risk of bias (ROB) tool. Inclusion and exclusion
criteria were predefined, and data extraction was performed to summarize the
findings.
Result A total of 12 randomized control trial (RCT) studies were included
in the present systematic review. 37,657 (54.89%) participants were randomly
assigned to receive the different interventions of SGLT-2 inhibitor, whereas
30,959 (45.11%) received a placebo. Overall, 618 events were reported in the
treatment group, whereas 396 events were reported in the placebo group.
Conclusion In conclusion, patients treated with SGLT-2 inhibitors did not
have any significant difference in amputation occurrences compared to placebo
across various studies. However, canagliflozin usage has led to higher
amputation events in certain trials.