Trial Investigating Dapagliflozin in CKD Meets All End Points
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
Kidney Disease
FDA Committee Narrowly Votes in Favor of Terlipressin for Hepatorenal Syndrome Type 1
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8 to 7 in favor of the approval of terlipressin for the treatment of adults with hepatorenal syndrome type 1
Tolvaptan Lowers Kidney Stone Risk in ADPKD
Tolvaptan improves the urinary lithogenic risk profile of patients with autosomal dominant polycystic kidney disease, according to researchers.
Lumasiran Granted Priority Review for Primary Hyperoxaluria Type 1
The FDA has accepted for Priority Review the New Drug Application for lumasiran for the treatment of primary hyperoxaluria type 1.
Lokelma Labeling Updated With Dosing for Hyperkalemia in Dialysis-Dependent ESRD
The prescribing information for Lokelma® (sodium zirconium cyclosilicate; AstraZeneca) has been updated to include a dosing regimen to treat hyperkalemia in patients with end-stage renal disease (ESRD) on chronic hemodialysis.
Patient’s Death Leads to Lawsuit After Physician Fails to Check Creatinine Level Before Infusing Drug
The month’s case involves a lawsuit against 2 healthcare professionals, a primary care physician and a rheumatologist. The patient, Mrs X, was a postmenopausal woman in her early 50’s. The mother of 3 adult children who had successfully worked for 15 years until her scleroderma made it increasingly difficult to type on a computer.
Dapagliflozin CKD Trial Stopped Early Due to “Overwhelming Efficacy”
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.
Triferic AVNU Approved for Iron Replacement and Hemoglobin Maintenance in Dialysis Patients
The FDA has approved the New Drug Application for Triferic AVNU®.
Update for SGLT2 Inhibitors: Temporary Discontinuation Prior to Surgery Recommended
The FDA has approved safety labeling changes for sodium glucose co-transporter-2 (SGLT2) inhibitors. These include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin.
Joint Statement Issued Addressing Concerns Over COVID-19 and ACE Inhibitor, ARB Use
Patients with cardiovascular disease diagnosed with novel coronavirus (COVID-19) are urged to continue taking their angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) medications as prescribed.
