A new study with ‘real world’ data shows greater efficacy of Victoza(R)

New data show that Victoza® (liraglutide [rDNA origin] injection) provided greater reductions in HbA1c compared to exenatide and DPP-4 inhibitors, with weight loss and cost-effectiveness, when used in routine primary care according to current UK type 2 diabetes treatment guidelines. The study presented at the 72nd Annual Scientific Sessions of the ADA in Philadelphia also shows that more patients appeared to favour a drug with a liraglutide-like profile, which is given by injection, over a drug with a sitagliptin-like profile, which is given orally.

“This study shows us that the results we’ve seen with liraglutide in clinical trials are reflected in day-to-day, real-world use,” said Marc Evans, study investigator from Llandough Hospital, Cardiff, Wales. “Key to managing diabetes is choosing treatments that patients will adhere to in order to get the best outcomes.”

The study looked at data from 1,114 type 2 diabetes patients from primary care practices in the UK and assessed the clinical efficacy and patient preference with respect to liraglutide, exenatide and DPP-4 inhibitors.

Key findings from the study include1:

• The results showed that greater reduction in HbA1c was seen in patients treated with liraglutide compared to exenatide or DPP-4 inhibitors (1.23% (±0.14), 0.79% (±0.19) and 0.72% (±0.23), p<0.05, n=1114).
• Significantly greater weight loss was seen in patients treated with liraglutide (n=256) compared to DPP-4 inhibitors (n=710) (-3.9 kg (±5.7) vs. -0.8 kg (±3.1), p<0.05) and greater weight loss was seen in patients treated with liraglutide (n=256) compared to exenatide (n=148) (-3.9 kg (±5.7) vs. -2.9 kg (±5.8)).
• More patients expressed a preference for a drug with a liraglutide-like profile over one with a sitagliptin-like profile (62.5% vs 37.5%, p<0.05).
• The calculated life years gained per patient was 0.12, 0.08 and 0.07 for those receiving liraglutide, exenatide or a DPP-4 inhibitor, respectively, compared to their respective baselines.
• Based on observed treatment effects, the United Kingdom Prospective Diabetes Study (UKPDS) 68 risk equations were applied over a 20-year time horizon to calculate cost-effectiveness. The observed cost/QALY (Quality Adjusted Life Years) vs baseline for patients receiving liraglutide, exenatide or a DPP-4 inhibitor was £16,505, £16,648 and £20,661, respectively. Costs were calculated using the most commonly prescribed DPP-4 inhibitor, sitagliptin.

About Victoza®

Victoza® is a human glucagon-like peptide-1 (GLP-1) analogue that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and to suppress glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.

Victoza® was approved on 30 June 2009 by the European Commission in all 27 European Union member states. In Europe, Victoza® is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control, in combination with metformin and or sulphonylurea or metformin and thiazolidinedione. On 25 January 2010, Victoza was approved in the US as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. Victoza® has been commercially launched in more than 50 countries globally, including the US, China, Japan, the Arabian Peninsula and a number of countries in Europe, Asia and South America. It will be available in other markets throughout 2012.

‘Real world’ studies and data

‘Real world’ studies, also known as ‘non-interventional’ or ‘observational’ studies, investigate how treatments are working in healthcare systems and in standard clinical practice. The data provide insights into outcomes (clinical and patient-reported), use of resources (healthcare systems, patient and societal), treatment pathways, service models and patient preference/experience/ compliance.

References

Evans M et al, Evaluating the Clinical and Cost-Effectiveness and Patient Preference of Incretin Therapies When Used in Accordance with National Guidelines in Routine UK Primary Care Practice; presented at American Diabetes Association Scientific Sessions 2012.

Victoza® [summary of product characteristics]. Bagsværd, Denmark: Novo Nordisk A/S; 2012.

Association of the British Pharmaceutical Industry (ABPI) ‘Guidance – Demonstrating Value with Real World Data: A practical guide’. 2011