Canagliflozin (Invokana, Janssen) improved renal outcomes and demonstrated potential renal protective effects, according to additional analyses from the CANVAS clinical trial presented at the American Society of Nephrology Kidney Week 2017 Annual Meeting. Officials with Janssen announced the results in a press release about the trial program.
The data underscore the potential improved renal outcomes and benefits in patients with type 2 diabetes who either have, or are at risk for, cardiovascular (CV) disease. Additionally, the results indicated that, compared to a placebo, canagliflozin reduced the risk of kidney disease progression, including significantly reducing urinary albumin excretion and stabilizing estimated glomerular filtration rate (eGFR).
According to the press release, the renal analyses showed that:
- Canagliflozin reduced the rates of several pre-specified major renal composite endpoints by up to 47%, such as end-stage kidney disease, doubled serum creatinine, or renal death.
- Urinary albumin excretion was 18% lower in all participants treated with canagliflozin compared with placebo. It was 34% lower in those participants with baseline macroalbuminuria. Median urinary albumin to creatinine ratio was 12.3 mg/g.
- Participants treated with canagliflozin experienced an initial fall in mean eGFR that gradually increased over the study duration. In contrast, participants treated with placebo experienced a progressive decline in eGFR. Mean baseline eGFR was 76.5 mL/min/1.73 m2.
- There was no increase in renal adverse events (serious or non-serious) compared to placebo, including acute kidney injury and hyperkalemia.
The CANVAS Program, composed of 2 large outcome studies (CANVAS and CANVAS-R) assessed the efficacy, safety, and durability of canagliflozin in more than 10,000 patients with type 2 diabetes who had either a prior history of cardiovascular disease or at least 2 CV risk factors. Data from the trials also showed that canagliflozin significantly reduced the combined risk of CV death, myocardial infarction, and nonfatal stroke versus placebo in patients type 2 diabetes at risk for, or with a history of, CV disease.
No new adverse effects during the additional analysis were reported.
Invokana (canagliflozin) Significantly improved renal outcomes and demonstrated potential renal protective effects in patients with type 2 diabetes who have or are at risk for cardiovascular disease [news release]. Janssen’s website. http://www.janssen.com/invokanar-canagliflozin-significantly-improved-renal-outcomes-and-demonstrated-potential-renal. Accessed November