Victoza® lowers the risk of microvascular events in the kidney in adults with type 2 diabetes at high CV risk
London, UK, 15 September 2016 – Novo Nordisk has announced new results from its LEADER cardiovascular (CV) outcomes trial, which show that the incidence of a composite outcome of renal microvascular events in adults with type 2 diabetes at high CV risk is significantly lower with the GLP-1 receptor agonist, Victoza® (liraglutide) compared to placebo, as measured by urinary albumin creatinine ratio, when both are added to standard of care1.
New onset or worsening kidney disease was a pre-specified secondary endpoint in the LEADER trial, the findings of which were presented today at the 52nd European Association for the Study of Diabetes (EASD) Annual Meeting, in Munich, Germany. Patients treated in the liraglutide group were found to have an overall risk reduction of 22% compared to the placebo group (1.5 vs 1.9 events per 100 patient-years of observation; p=0.003), across all subgroups (patients with no, mild or moderate renal impairment)1.
Today’s results are important as approximately 20% to 30% of people with type 2 diabetes develop moderate to severe renal impairment2, which accounts for 11% of deaths across the type 2 diabetes population3.
Professor Steve Bain, UK LEADER trial National Leader and Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Unit, Wales, commented: “By the time people with type 2 diabetes are diagnosed, many of them will already show signs of kidney damage. Not only does this complication add to the overall burden of the disease, it can also impact the anti-diabetic treatment choices available to them. Our latest findings are promising, as liraglutide has the potential to reduce the risk of kidney disease in adults with type 2 diabetes at high cardiovascular risk.”
The proportion of adults experiencing adverse events was similar between the liraglutide and the placebo groups (62.3% vs 60.8% respectively). The most common adverse events leading to the discontinuation of liraglutide were gastrointestinal events, such as nausea. Severe hypoglycaemic events were greater in the placebo group compared to patients treated with liraglutide (3.3 vs 2.4%; p=0.02). Acute gallstone disease was significantly higher in the liraglutide group (3.1%) vs placebo (1.9%), p<0.001. The incidence of pancreatitis was similar across the liraglutide and placebo groups (18 patients versus 23 patients respectively)4.
NOTES TO EDITORS
LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term effects of Victoza® (liraglutide) up to 1.8 mg compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major cardiovascular events4. Standard of care was defined as lifestyle modifications, selective glucose lowering treatments and cardiovascular medications5.
LEADER was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries that were followed for 3.5–5 years4. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke4.
Diabetic kidney disease was assessed by the primary renal outcome, defined as a composite of: high levels of a protein called albumin found in the urine (new onset of persistent macroalbuminuria); kidney filtration function (persistent doubling of serum creatinine); need for dialysis (continuous renal replacement therapy); or death due to kidney disease4.
Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) receptor agonist with an amino acid sequence 97% similar to endogenous human GLP-1.
Liraglutide was launched in the EU in 2009 and is commercially available in more than 80 countries with more than 3 million patient years of use in people with type 2 diabetes globally. In the UK, liraglutide is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.6
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
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1. Results of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial. Presentation at the 52nd European Association for the Study of Diabetes (EASD) Annual Meeting. 15 September 2016.
2. Inzucchi E, Bergenstal M, Buse B, et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2012;35:1364-1379.
3. Morrish NI, Wang SL, Stevens LK, et al. Mortality and causes of death in the WHO multinational study of vascular disease in diabetes. Diabetologia 2001;44(Suppl2):s14-s21.
4. Marso S, Daniels G, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine 2016; 375:311-322.
5. Marso S, Daniels G, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. Supplementary Information. New England Journal of Medicine 2016; 375:311-322.
6. EMC. Victoza® UK summary of product characteristics. June 2016. Available at: https://www.medicines.org.uk/emc/medicine/21986#INDICATIONS. Last accessed September 2016.Editor's Details
Last updated on: 16/09/2016
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