Bardoxolone Clinical Trials
Bardoxolone Methyl Linked to Increased Risk of Death
In October 2012, an independent data monitoring committee ordered that Reata Pharmaceuitcals terminate a phase 3 clinical trial for their investigational drug bardoxolone methyl due to increased reports of major cardiovascular events and death. Reata is now pursuing new clinical research for the drug, despite these serious risks.
REATA TERMINATES THE BEACON TRIAL
In the BEACON Trial, Reata was testing bardoxolone as a possible treatement for chronic kidney disease in patients diagnosed from type 2 diabetes mellitus. Unfortunately, clinical data indicates that these patients were put at an increased risk of suffering serious cardiovascular events and death.
According to clinical trial data:
- 1,255 adverse events were reported by patients receiving bardoxolone.
- 139 patients receiving bardoxolone suffered non-fatal heart attacks, non-fatal stoke, were hospitalized for heart failure, or died from cardiovascular causes.
- 96 reports of heart failure were recorded in patients taking bardoxolone.
By the time the trial was terminated, 27 patients being treated with bardoxolone had died from cardiovascular causes, compared to 19 cardiovascular deaths recorded in the placebo group. To make matters worse, the New England Journal of Medicine concluded that bardoxolone was ineffective at preventing the progression of end stage renal failure, meaning patients receiving the drug had not benefited from their treatment.
Despite their previous trial being terminated for cardiovascular events, Reata is now recruiting patients for a clinical trial assessing bardoxolone’s effecicy as a potential treatment for pulmonary arterial hypertension – a leading cause of heart failure.
SIDE EFFECTS OF BARDOXOLONE
The following adverse events were reported in patients being treated with bardoxolone:
- Muscle pain
- Upper and lower respiratory tract infection
- Abnormal breathing
- Gastrointestinal symptoms
- Renal failure
- Heart failure