Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
*The following was added:
- Dual blockade…RAS… The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinaryalbumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end state renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. In general, avoid combined use of RAS inhibitors.
- Do not co-administer aliskiren with ZESTORETIC in patients with diabetes
- …and mood alterations (including depressive symptoms)