Study Finds Jardiance Does Not Significantly Reduce Heart Failure or Mortality Rates Among Patients

Research questions the supposed heart benefits of Jardiance, while other diabetes drugs are under fire for concerns over stomach paralysis risks.

Despite prior research suggesting Jardiance may offer cardiovascular health benefits, a recent study has found that the new generation Type II diabetes drug does not significantly reduce the risk of heart attack or heart failure.

Jardiance (empagliflozin) belongs to a class of diabetes drugs, known as sodium glucose cotransporter-2 (SGLT-2) inhibitors, which also includes the controversial drugs Invokana, Invokamet, Farxiga and Xigduo.

The FDA first approved Jardiance for the treatment of Type II diabetes on August 1, 2014, and clinical trials later suggested in August 2015 that the drug could offer potential heart benefits that could reduce the risk of cardiovascular death, non-fatal heart attacks and strokes.

However, a recent study indicates the advertised heart health benefits of Jardiance are not statistically significant, or superior to alternative therapies.

New Study Challenges Jardiance Cardiovascular Benefits

In findings published in The New England Journal of Medicine on April 6, researchers examined the effects of Jardiance on patients who recently had a heart attack and were at risk of heart failure.

The study included 3,260 patients given Jardiance and 3,262 received a placebo, with neither patients nor researchers knowing who received which treatment. The goal was to determine if Jardiance could prevent hospitalizations for heart failure or deaths compared to the placebo.

After approximately 18 months of follow-up, researchers found that 267 patients (8.2%) in the Jardiance group and 298 patients (9.1%) in the placebo group were hospitalized for heart failure or died. This equates to about six out of every 100 people per year for the Jardiance group and about 7 out of every 100 people per year for the placebo group.

Focusing specifically on heart failure hospitalizations, 118 patients (3.6%) taking Jardiance and 153 patients (4.7%) taking the placebo were hospitalized. The researchers concluded that Jardiance did not show a significant difference compared to the placebo in reducing the risk of hospitalization for heart failure or death in patients prone to heart failure after a heart attack.

Drug Stomach Paralysis Lawsuits

The findings come amid increasing concerns about the potential side effects of some competing diabetes drug, which have also become popular for use to promote weight loss, including Ozempic, Mounjaro and Trulicity.

While the drugs were initially introduced for treatment of type 2 diabetes, the popularity has skyrocketed in recent years as diet drugs, and amid similar findings that suggest the treatments also provide cardiovascular health benefits. However, there are now growing concerns about potential gastrointestinal side effects, which may leave some users with severe nausea, vomiting, and diarrhea, as well as a form of stomach paralysis known as gastroparesis.

Novo Nordisk now faces an increasing number of Ozempic stomach paralysis lawsuits over its alleged failure to warn about the potential side effects while promoting the weight and heart benefits of the treatment. In addition, Eli Lilly faces similar Mounjaro lawsuits, since it’s competing drug has a similar mechanism of action.

Given common questions of fact and law being presented in stomach paralysis claims being pursued throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to centralize all Ozempic and Mounjaro lawsuits in February, transferring complaints filed nationwide involving the use of GLP-1 RA diabetes or weight loss drugs to U.S. District Judge Gene E.K. Pratter in the U.S. District Court for the Eastern District of Pennsylvania, for coordinated discovery and pretrial proceedings.

As lawyers continue to review and file Ozempic lawsuits in the coming months, it is widely expected that thousands of lawsuits will be transferred to the GLP-1 MDL, as nearly 2% of the U.S. population has been prescribed one of the GLP-1 medications, either for diabetes treatment or weight loss.