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Jan 21, 2017

CV data added to labels for treatments containing empagliflozin.

It is a known fact that most people with diabetes will not die from diabetes but from cardiovascular disease as a heart attack, stroke or other CVD incident.


The FDA recently approved supplemental New Drug Applications for type 2 diabetes treatments that include empagliflozin to add in results from the EMPA-REG Outcome trial, according a press release from Eli Lilly and Company.

When compared with placebo, empagliflozin reduced the risk for cardiovascular death when added to standard type 2 diabetes care and CV medications in adults with type 2 diabetes and CV disease.

Boehringer Ingelheim and Eli Lilly’s supplemental new drug applications for three type 2 diabetes drugs — Glyxambi, Synjardy and Synjardy XR — have been approved by the FDA. Their labels will now include data showing that the drugs can reduce the risk of cardiovascular deaths as compared with placebo when added to standard of care medicines for adults with type 2 diabetes and cardiovascular disease.

The new data were added to the clinical studies sections of the prescribing information for Synjardy (empagliflozin and metformin hydrochloride, Boehringer Ingelheim and Eli Lilly), Synjardy XR (empagliflozin and metformin hydrochloride extended release, Boehringer Ingelheim and Eli Lilly) and Glyxambi (empagliflozin and linagliptin, Boehringer Ingelheim and Eli Lilly).

The addition of these data to the Synjardy, Synjardy XR and Glyxambi labels will help physicians better understand the available clinical trial evidence in order to help their patients who have type 2 diabetes and CVD.

Thomas Seck, MD, vice president of clinical development and medical affairs, for Boehringer Ingelheim Pharmaceuticals Inc., said in the release: “As part of our long-standing and continuing efforts to help adults with type 2 diabetes, we are pleased that our discussions with the FDA have resulted in these important label updates.”

The RR for CV death, nonfatal heart attack and nonfatal stroke was reduced by 14% with empagliflozin compared with placebo (HR = 0.86; 95% CI, 0.74-0.99).

Serious adverse events, including lactic acidosis, were reported with the use of Synjardy and Synjardy XR.

Practice Pearls:

  • Empagliflozin is not indicated for use in adults with severe kidney problems.
  • CV death reduction claim was approved for 3 new drug combos.
  • The RR for CV death, nonfatal heart attack and nonfatal stroke was reduced by 14% with empagliflozin compared with placebo.

FDA to review 3 new diabetes drugs that reduce cardiovascular death risk. European Pharmaceutical Review (U.K.). http://www.europeanpharmaceuticalreview.com/46724/news/industry-news/fda-review-new-diabetes/