Study Claims Jardiance Lowers Heart Attack, Stroke Risk, But Ketoacidosis Concerns Remain
Eli Lilly and Boehringer Ingelheim claim that their diabetes drug Jardiance is the first to demonstrably reduce the risk of heart attacks and strokes. However, the announcement comes as the new-generation diabetes treatment and other members of the same class, which includes Invokana and Farxiga, are under increased scrutiny over concerns that they may increase the risk of ketoacidosis.
In a press release issued August 20, the drug manufacturers reported that a long-term clinical trial for Jardiance, involving more than 7,000 adults with type 2 diabetes, showed reductions in cardiovascular death, non-fatal heart attacks and strokes.
The study does not appear to have been peer reviewed or published yet, but the manufacturers claim that it is the first glucose-lowering drug to have shown a reduced cardiovascular risk in clinical trials.
Jardiance belongs to a new class of type 2 diabetes medications introduced in recent years, known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Other members of the same class include Invokana, Farxiga, Invokamet, Glyxambi and Xigduo XR.
In May, the FDA announced that it is investigating whether regulatory actions are necessary as a result of recent reports involving ketoacidosis problems with Jardiance and other SGLT2 inhibitor diabetes drugs.
Ketoacidosis occurs when high levels of blood acids, known as ketones, build up in the blood. This can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment and potentially resulting in severe health consequences.
Concerns about the potential link between Invokana and ketoacidosis emerged in May, when the FDA indicated that during the first 15 months the new class of diabetes drugs was on the market, more than 20 adverse event reports were received involving individuals using an SGLT2 inhibitor who required emergency room treatment or hospitalization due to diabetic ketoacidosis, ketosis, acidosis or other related conditions.
Although diabetic ketoacidosis is commonly associated with type 1 diabetes, it is not normally seen among individuals diagnosed with type 2 diabetes, which is the type of diabetes Jardiance and the other drugs are approved to treat. Type 2 diabetes is an acquired and curable condition, while type 1 diabetes is usually something someone is born with and persists for life.
A growing number of lawyers are now reviewing potential Jardiance lawsuits, as well as Invokana lawsuits, Farxiga lawsuits and claims involving other members of the class, for individuals hospitalized due to ketoacidosis. Plaintiffs claim that the drug makers failed to adequately research the potential side effects before aggressively marketing the new generation diabetes treatments.