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Is amputation risk increased with SGLT2 inhibitors in T2D: Dr. Tiwaskar reviews

M3 India Newsdesk Aug 29, 2018

Dr. Tiwaskar, a noted physician,  reviews the article on SGLT2 inhibitors and their association with lower-extremity amputation among  Type 2 Diabetes patients.

 

 

 

 

 

 

This article got published in 3 peer-reviewed international journals - Cardiology, Primary care and Diabetes with the commentary written by experts like Peter Lin, Ketan Dhatariya. You may read it here.

When the CANVAS program was reported, there was an increase in amputation rates in the canagliflozin arm and there is no clear explanation of why this occurred. However, after examining data relative to the other SGLT2 inhibitors, the FDA detected no amputation risk. Hence, the warning was just with canagliflozin.

Now the European drug agency found the opposite and reported that increased amputation risk was a class effect. So, who is right?

So, a retrospective cohort study was conducted using Truven Health MarketScan Commercial Claims and Encounters data on new users between September 1, 2012, and September 30, 2015 and almost 2 million potential patients screened which included 39 869 new users of SGLT-2 inhibitors and were compared with DPP4 inhibitors, GLP-1 Analogs, and Older OHAs like Suphonylureas, Thiazolidinediones and Metformin.

After the propensity score weighting and adjustment for demographics, severity of diabetes, co-morbidities, and medications, there was a non-statistically significant increased risk of amputation associated with new use of SGLT-2 inhibitors compared with DPP4 inhibitors (adjusted hazard ratio, 1.50; 95% CI, 0.85-2.67) and GLP-1 agonists (adjusted hazard ratio, 1.47; 95% CI, 0.64-3.36), but was statistically significantly associated with amputation compared with sulfonylureas, metformin, or thiazolidinediones (adjusted hazard ratio, 2.12; 95% CI, 1.19-3.77). These results persisted in sensitivity analyses. There were 18 amputations reported and the mean follow-up was only 115 days.

The researchers concluded that there seemed to be an increased risk of amputation with SGLT2 inhibitors.

Though further observational studies are needed with extended follow-up and larger sample sizes, it is only imperative that we, physicians,  should be more vigilant for this especially in high-risk group of patients with H/O previous amputations, PAD, Smokers, Foot issues etc.

 


Disclaimer- The opinion and the views expressed above are those of the writer, a qualified medical professional and do not, in any way, reflect the position of M3 India or its associates.

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