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Study Indicates Empagliflozin May Reduce Cardiovascular Event Risks

NEJM reports favorable data on mortality and certain other outcomes

Empagliflozin (Jardiance, Eli Lilly/Boehringer Ingelheim) can potentially reduce the risk of cardiovascular events, according to a study published in the New England Journal of Medicine.

Researchers randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. A total of 7,020 patients were treated (median observation time, 3.1 years).

The primary outcome occurred in 490 of 4,687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2,333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95% confidence interval, 0.74–0.99; P = 0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, versus 5.9% in the placebo group; 38% relative risk (RR) reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% RR reduction), and death from any cause (5.7% and 8.3%, respectively; 32% RR reduction).

There was no significant between-group difference in the key secondary outcome (P = 0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events.

Patients with type-2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. The drug reduced the overall risk of having a heart attack or stroke, or of dying from cardiovascular causes, by 14%. Looking only at cardiovascular deaths, the reduction was 38%.

“There are very few therapies we have in cardiovascular medicine that have ever shown a one-third reduction in the risk of cardiovascular death,” said Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who was not involved in the study.

Still, there were some questions about the data. The drug did not reduce the risk of heart attacks overall by a statistically significant amount, and it actually seemed to raise the risk of stroke, though not by a statistically significant amount.

So how did it reduce deaths from cardiovascular causes? One way, not necessarily expected, was by reducing deaths from heart failure.

Tim Anderson, pharmaceutical analyst at Sanford C. Bernstein & Company, tripled his estimate of Jardiance sales in 2020 to $2.7 billion. Sales of two other drugs in the same class, known as SGLT2 inhibitors, might also increase, even though there is no data showing that they decrease cardiovascular risk.

Sources: New England Journal of Medicine; September 17, 2015; The New York Times; September 17, 2015.

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