Hot of the presses is the news that the BEACON trial has been stopped prematurely by the data monitoring committee.
Recall the NEJM paper published in 2011 by Pergola and colleagues.
Here is the report from Wikipedia: "Bardoxolone methyl was previously being investigated by Reata Pharmaceuticals, Inc. in partnership with Abbott Laboratories and Kyowa Hakko Kirin, as an experimental therapy for advanced chronic kidney disease (CKD) in type 2 diabetes mellitus patients. Reata, in consultation with the BEACON Steering Committee, has decided to terminate the Phase 3 BEACON trial of bardoxolone methyl in patients with stage 4 chronic kidney disease and type 2 diabetes. This decision was made based upon a recommendation of the Independent Data Monitoring Committee (IDMC) to stop the trial "for safety concerns due to excess serious adverse events and mortality in the bardoxolone methyl arm."
Pergola and colleagues performed a phase 2, double-blind, randomized, placebo-controlled trial of 227 adults with CKD GFR of 20-45 ml/min/1.73m2.
"Patients receiving bardoxolone methyl had significant increases in the mean (±SD) estimated GFR, as compared with placebo, at 24 weeks."
They reported mild side effects (with bardoxolone methyl doses of 25, 75, or 150 mg once daily): muscle spasms, being the most frequent adverse event in the bardoxolone methyl groups,. Hypomagnesemia, mild increases in alanine aminotransferase levels, and gastrointestinal effects were more common among patients receiving bardoxolone methyl.
Pergola et al concluded that "Bardoxolone methyl was associated with improvement in the estimated GFR in patients with advanced CKD and type 2 diabetes at 24 weeks. The improvement persisted at 52 weeks, suggesting that bardoxolone methyl may have promise for the treatment of CKD".
"Patients receiving bardoxolone methyl had significant increases in the mean (±SD) estimated GFR, as compared with placebo, at 24 weeks."
They reported mild side effects (with bardoxolone methyl doses of 25, 75, or 150 mg once daily): muscle spasms, being the most frequent adverse event in the bardoxolone methyl groups,. Hypomagnesemia, mild increases in alanine aminotransferase levels, and gastrointestinal effects were more common among patients receiving bardoxolone methyl.
Pergola et al concluded that "Bardoxolone methyl was associated with improvement in the estimated GFR in patients with advanced CKD and type 2 diabetes at 24 weeks. The improvement persisted at 52 weeks, suggesting that bardoxolone methyl may have promise for the treatment of CKD".
kidney stone
ReplyDeleteKidney stone is a disease in the urinary tract wherein specks of minerals form into the urinary tract and even within the kidneys and as a result, it causes pain and discomfort.