EASD: SGLT2 inhibitor empagliflozin cuts CV risk in patients with type 2 diabetes
AT EASD 2015
The key secondary outcome of the trial was a composite of the primary outcome plus hospitalization for unstable angina. However, no significant difference for superiority was seen between the groups (P = .008, P less than .001 for noninferiority).
“I am here because of the importance of this,” said Dr. Andrew Boulton outgoing president of the EASD and professor of medicine at the University of Manchester, England, who introduced the EASD-sponsored symposium where the results were revealed.
In an interview, Dr. Boulton said it “looks promising.”
The results were presented by the senior authors of the study and independently commented upon afterward by the EASD-invited discussant Dr. Hertzel Gerstein of McMaster University and Hamilton (Ont.) Health Sciences. “Without question, the EMPA-REG investigators have designed a good protocol, and they have answered a very important question,” he said. “This was a well done and very important study,” he noted.
Dr. Gerstein observed that empagliflozin “clearly reduces CV death and heart failure hospitalization,” an effect that starts to appear after just 3 months. This early effect is unlikely to be down to just glucose-lowering, antihypertensive effects of the background medications used, or weight loss because of this speed of onset. It could be due to the diuretic properties of the SLGT2 inhibitor or, maybe more likely, a combination of beneficial effects. “It is probably a class effect,” he said, “but you can never be certain.”
Based on the findings, he suggested that empagliflozin “may become first-line treatment for middle aged people with type 2 diabetes at risk for CV outcomes” and that the trial had “identified a treatment that could save many lives and reduce much suffering.” The results were unexpected and will open up new avenues for research.
Dr. Bernard Zinman of Mount Sinai Hospital, Toronto, lead author for the trial, said during the session that the number of patients needed to be treated with empagliflozin for 3 years to prevent one cardiovascular death was 39. By comparison, he said, the numbers needed to treat with simvastatin or ramipril for 5 years were 30 and 59, respectively.
Good safety was observed in the trial, reported Dr. David Fitchett, fellow author. Dr. Fitchett, a cardiologist at St Michael’s Hospital and associate professor at the University of Toronto, noted that overall rates of both any adverse events and serious adverse events were similar between the groups, with the exception of genital infections that were mainly mycoses and mostly in women.
Rates of confirmed hypoglycemic events were similar, he said, and there was no increase in diabetic ketoacidosis or bone fracture, which have been the focus of recent warnings issued by the Food and Drug Administration with regard to SLGT2 inhibitors.
Boehringer Ingelheim and Eli Lilly funded the study. Dr. Sattar disclosed ties with Amgen, Sanofi, and Merck Sharp & Dohme. Dr. Sattar and Dr. Rydén were on the panel of experts invited to talk about the study in a satellite symposium sponsored by Boehringer Ingelheim and Eli Lilly. Dr. Boulton did not report having disclosures. Dr. Gerstein reported ties with Sanofi, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Merck Sharp & Dohme, Novo Nordisk, Abbot, Bayer, Berlin Chemie, Roche, GSK, Amgen, and Kaneq Bioscience. Dr. Zinman disclosed ties with Boehringer Ingelheim. Dr. Fitchett disclosed consulting for Boehringer Ingelheim, Novo Nordisk, AstraZeneca, and Merck Sharp & Dohme. Dr. Inzucchi disclosed ties with Boehringer Ingelheim, Merck, Janssen, Novo Nordisk, Sanofi/Regeron, Intarcia, Lexicon, Paxel, Takeda, and Eli Lilly. He acknowledged CME-funding to Yale University from Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Abbot, Merck Sharp & Dohme, and Sanofi.
