EASD 2016: Renal benefit seen with Victoza in LEADER 3 unlikely to lead to label expansion.
By Kevin Shannon, Analyst
22 September 2016
I am an analyst at Datamonitor Healthcare, currently located in San Diego, California, where I am a member of the cardio...
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Additional data from Victoza’s (liraglutide; Novo Nordisk) LEADER 3 cardiovascular outcomes trial in type 2 diabetes were presented on 15 September 2016 at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2016). The results suggest that Victoza may have a potential renal benefit, as investigators reported reduced incidence of renal microvascular events. However, the reduction in composite outcome renal microvascular events was driven primarily by decreased new onset of persistent macroalbuminuria. This endpoint is generally considered not to have a strong association with renal outcomes, and is unlikely to generate growth or provide compelling evidence for a label addition for Victoza on its own.
Victoza’s failure to show a reduction in measures associated with renal outcomes represents a missed opportunity to meet a huge unmet need in type 2 diabetes. Approximately 20–30% of patients with type 2 diabetes develop moderate to severe renal impairment (Inzucchi et al., 2012). This accounts for 11% of deaths within the type 2 diabetes population (Morrish et al., 2001), and also limits the type of antidiabetic treatments available to patients.
Results from the LEADER 3 trial demonstrated that Victoza reduced the number of microvascular events (renal and eye events) by a statistically significant 16%. This reduction was driven entirely by decreased instance of renal events, which were reduced by 22% compared to an insignificant increase in eye events. The renal benefit with Victoza was seen early in treatment (12 months after randomization) and continued to increase throughout the duration of the trial. Interestingly, there was no significant difference in the doubling of serum creatinine, need for continuous renal replacement therapy, or death due to renal disease between the two arms of the study. These three endpoints are more strongly associated with renal outcomes than onset of persistent macroalbuminuria, the main driver behind the significant reduction in composite outcome renal microvascular events observed. This will make it difficult for Novo Nordisk to gain a label addition for or generate additional uptake of Victoza, as current results from the LEADER 3 trial are not compelling evidence that Victoza will have a clinically significant benefit on renal outcomes.
Inzucchi E, Bergenstal M, Buse B, Diamant M, Ferrannini E, et al. (2012) Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Diabetes Care, 35(6), 1364–79 <DOI>10.2337/dc12-0413</DOI>.
Morrish NI, Wang S, Stevens L, Fuller J, Keen H (2001) Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia, 44(Suppl2), S14–S21 <PMID>11587045</PMID>.
Novo Nordisk (2016) Victoza® lowered the progression of kidney damage in adults with type 2 diabetes at high CV risk. Available from: http://www.novonordisk.com/media/news-details.2042438.html [Accessed 19 September 2016].
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