For adult patients with type 2 diabetes and moderatea renal impairment,
Victoza® provided significant A1C reductions over 26 weeks1
The safety and tolerability of Victoza® in special populations, including patients with moderate renal impairment.
aModerate renal impairment=eGFR 30 to 59 mL/min/1.73 m2.1
Victoza® is not filtered by the kidneys2
No significant difference in renal function vs placebo as measured by eGFR1
Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.
Victoza® provided the added benefit of weight loss1
Safety profile of Victoza® in patients with moderate renal impairment
Adverse reactions reported in ≥5% of patients and occurring more frequently with Victoza® compared with placebo included1:
- Nausea (21.4% vs 4.4%), vomiting (12.1% vs 2.2%), diarrhea (7.1% vs 2.9%), constipation (5.7% vs 1.5%), increased lipase (15.0% vs 8.8%), GFR rate decreased (6.4% vs 5.1%), and headache (5.0% vs 2.9%)
In the Victoza® (LEAD 1-5) trials, 20% (797) of patients were at least 65 years old.
No overall differences in safety or effectiveness were seen when compared with younger patients
Greater sensitivity of some older individuals cannot be ruled out
eGFR=estimated glomerular filtration rate.
A 26-week, double-blind, placebo-controlled, parallel-group, randomized study in adult patients with type 2 diabetes and moderate renal impairment (eGFR 30-59 mL/min/1.73 m2). Patients were randomized to receive Victoza® 1.8 mg (n=140) or placebo (n=139) in addition to existing oral antidiabetics and/or insulin therapy. The primary endpoint was change in A1C.1
References: 1. Davies MJ, Bain SC, Atkin SL, et al. Efficacy and safety of liraglutide versus placebo as add-on to glucose-lowering therapy in patients with type 2 diabetes and moderate renal impairment (LIRA-RENAL): a randomized clinical trial. Diabetes Care. 2016;39(2):222-230. 2. Malm-Erjefält M, Bjørnsdottir I, Vanggaard J. Metabolism and excretion of the once-daily human glucagon-like peptide-1 analog liraglutide in healthy male subjects and its in vitro degradation by dipeptidyl peptidase IV and neutral endopeptidase. Drug Metab Dispos. 2010;38(11):1944-1953.