More work needs to be done to examine the real world effects of empagliflozin, new research finds

Examining data from over 60,000 patients with type 2 diabetes, researchers from the University of Surrey found that the highly-publicised cardiovascular benefits of empagliflozin cannot be applied to the majority of patients with the illness.

The study, Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol), was published in Diabetes Therapy.

“Recent findings from the first complete cardiovascular safety trial in SGLT2 inhibitors, the Empagliflozin, Cardiovascular Outcomes, and Mortality in type 2 diabetes (EMPA-REG OUTCOMES) trial, demonstrated reduced cardiovascular outcomes in people with high cardiovascular risk,” the authors (McGovern, A., Feher, M., Munro, N. et al) write.

“How to apply these findings to clinical practice remains unclear, with questions remaining on who will reap this cardiovascular benefit.”

The authors say the trial had limitations due to its focus on patients identified as high risk of cardiovascular disease.

Other cardiovascular safety trials on SGLT2 inhibitors are still ongoing.

The University of Surrey researchers examined the potential impact of the drug on those deemed at lower risk of cardiovascular disease, and found that only 11% of patients with type 2 diabetes who were prescribed empagliflozin were identified as being at as high a risk of cardiovascular disease as those in the trial.

They concluded that these patients may not see any cardiovascular improvements from the drug. Similarly, only 16% of patients with type 2 diabetes who were not prescribed the drug were identified as being as high a risk of cardiovascular disease as those in the trial.

Such findings highlight the limitations of clinical trials, the authors say, which are often only directly applicable to a small proportion of people for whom the medications are prescribed and often leads to misconceptions about the workings of the drug.

Lead author of the paper, Dr Andy McGovern, from the University of Surrey said: “The benefits of this drug for patients at high risk of cardiovascular disease are clear. However what we have found a major limitation of the clinical trial; it can only be applied to a small proportion of people with type 2 diabetes.

“Recognising this shortcoming will help clinicians better explain to patients how this drug will benefit them.”

Two trials run across 30 countries have also found that canagliflozin, another SGLT2 inhibitor, significantly reduced the risk of cardiovascular and kidney disease.

However, data showed that participants receiving canagliflozin were twice as likely to suffer from amputation of toes, feet or legs as those in the placebo group.

“Amputations are definitely something to be concerned about,” lead author Professor Bruce Neal, from The George Institute for Global Health, told the AJP.

“What we need to do is try to figure out who is most likely to benefit from this drug, and those who is more likely to be harmed.”