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New EMPRISE Data Show Reduced Risk of HF Hospitalization With Empagliflozin, Less Healthcare Utilization

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EMPRISE (Empagliflozin Comparative Effectiveness and Safety) will examine 5 years of real-world data on empagliflozin, which is sold as Jardiance by Eli Lilly and Boehringer Ingelheim. The study is comparing data on empagliflozin with that for dipeptidyl peptidase 4 (DPP-4) inhibitors. This latest interim analysis also features a cohort comparison with glucagon-like peptide 1 (GLP-1) receptor agonists.

New data from an ongoing real-world study of empagliflozin show that the sodium-glucose co-transporter 2 (SGLT2) inhibitor was linked to less hospitalization for heart failure (HF) than 2 other drug classes for type 2 diabetes (T2D).1

EMPRISE (Empagliflozin Comparative Effectiveness and Safety) will examine 5 years of real-world data on empagliflozin, which is sold as Jardiance by Eli Lilly and Boehringer Ingelheim. The study is comparing data on empagliflozin with that for dipeptidyl peptidase 4 (DPP-4) inhibitors. This latest interim analysis also features a cohort comparison with glucagon-like peptide 1 (GLP-1) receptor agonists.

This interim analysis included 190,000 adults with T2D, with and without cardiovascular disease (CVD).

A separate abstract, also presented this weekend at the 2019 American Heart Association Scientific Sessions in Philadelphia, Pennsylvania, shows that patients with T2D who start taking empagliflozin have less healthcare utilization than those who start taking DPP-4 inhibitors,2 a class that includes the top-selling sitagliptin (Januvia). The largest reductions in the likelihood of using healthcare occurred among those who had both T2D and CVD.

For the main analysis, researchers from the Division of Pharmacoepidemiology at Brigham and Women's Hospital and Harvard Medical School used data from 2 commercial datasets covering the period from August 2014 through September 2017, and Medicare fee-for-service from August 2014 through September 2016. The team created 31,948 pairs of 1:1 propensity score-matched T2D patients at least 18 years of age who began taking empagliflozin or a DPP-4 inhibitor, and then created 46,427 matched pairs who began taking empagliflozin or a GLP-1 receptor agonist. The main 3-year analysis found the following:

  • Empagliflozin was associated with a 41% risk reduction in hospitalization for heart failure compared with DPP-4 inhibitors and 17% compared with GLP-1 receptor agonists.
  • In the first cohort, with an average age of 57.6 years, risk for non-fatal cardiovascular (CV) events, including heart attacks, strokes, hospitalization for unstable angina (chest pains), or coronary revascularization, was similar between empagliflozin with 14.6 events per 1000 patient years, and DPP-4 inhibitors, at 17.6 events per 1000 patient years.
  • In the second cohort, with an average age of 58.5 years, the risk for the non-fatal CV events was also similar between empagliflozin (14.2 events per 1000 patient years) and GLP-1 receptor agonists (14.8 events per 1000 patient years).

In the healthcare utilization analysis, the researchers studied claims involving the 31,948 matched pairs initiating empagliflozin or DPP-4 inhibitors and found the following:

  • Compared with those starting DPP-4 inhibitors, the hazard ratio (HR) for the first hospitalization for those starting empagliflozin was 0.78 (95% CI, 0.66-0.94) for those with CVD, and 0.83 (95% CI, 0.74-0.98) for those without CVD.
  • Compared with those starting DPP-4 inhibitors, those starting empagliflozin—both with and without CVD—had lower numbers of hospital admissions, with an incidence rate ratio (IRR) = 0.82 for those with CVD and IRR = 0.81 for those without CVD.
  • Empagliflozin initiators also had fewer emergency department visits, with an IRR = 0.63 for those with CVD and IRR = 0.77 for those without.

According to the researchers, in patients with and without CVD, per member per year in-hospital days and length of stay among those starting empagliflozin tended to be lower than those starting DPP-4 inhibitors.

“Over a mean follow-up of 6 months, there was a consistent reduction in inpatient and ED-related [reduced healthcare utilization] associated with empagliflozin vs DPP-4 inhibitor initiation in both patients with and without CVD,” the researchers wrote, “with larger benefits for empagliflozin among patients with CVD on an absolute risk scale.”

“Heart failure is a leading cause of hospitalizations in the United States, with about 1 million admissions annually, yet treatment options that are available for people living with this debilitating disease are not adequate to improve the problem,” Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development and Medical Affairs, Cardio-Metabolism and Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc., said in a statement. “Data showed that Jardiance reduced the risk of hospitalization for heart failure in adults with type 2 diabetes with and without cardiovascular disease in both routine clinical practice and in a clinical trial setting.”

References

  1. Patorno E, Pawar A, Franklin J, et al. Cardiovascular effectiveness compared to DPP-4 inhibitors and to GLP-1 receptor agonists: interim analysis from the empagliflozin comparative effectiveness and safety (EMPRISE) study. Circulation. 2019; 140:suppl A11928.
  2. Najafzadeh M, Pawar A, Schneeweiss S, et al. Healthcare resource utilization among empagliflozin initiators with and without cardiovascular disease versus DPP4i in a commercially-insured routine care population: an analysis from the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study. Circulation. 2019; 140:suppl 1. A13655.
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