Peripheral arterial disease (PAD) patients face a high risk of limb amputation, according to the European Journal of Vascular and Endovascular Surgery.
The ultimate aim of this study was to assess the link between long term risk of hospitalization for heart failure (HHF) and lower extremity minor and major amputation (LEA) in patients initiating sodium glucose cotransporter 2 inhibitors (SGLT2i) suffering from type 2 diabetes and PAD.
To conduct this study, researchers used BARMER German health claims data, which included including all patients suffering from type 2 diabetes initiating SGLT2i therapy between 1 January 2013 and 31 December 2019 with follow up until the end of 2020. New users of glucagon like peptide 1 receptor agonists (GLP1-RAs) were used as active comparators, the researchers noted. Inverse probability weighting with truncated stabilized weights were used to adjust for confounding, while Cox regression were used to analyze HHF and LEA data. Periods before and after the EMA warning were analyzed separately and stratified by presence of concomitant PAD, the investigators further noted. Overall, the analysis included 44, 284 (13.6% PAD) and 56,878 (16.3% PAD) patients initiated SGLT2i or GLP1-RA, respectively.
According to the results, prior to the the EMA warning, initiation of SGLT2i was associated with a lower risk of HHF in patients with PAD (HR=0.85, 95% CI, 0.73-0.99) as well as a higher risk of LEA in patients without PAD (HR=1.79, 95% CI 1.04 – 2.92). After the EMA warning, the efficacy and safety endpoints were no longer statistically different between groups.
“The results from this large nationwide real world study highlight that PAD patients exhibit generally high amputation risks,” the researchers concluded. “This study refutes the idea that the presence of PAD explains the excess LEA risk associated with initiation of SGLT2i. The fact that differentials among study groups diminished after the EMA warning in early 2017 emphasizes that regulatory surveillance measures worked in everyday clinical practice.”