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New licensed treatment for Type 2 Diabetes launched in the UK with Cardiovascular Outcomes Evidence

Vipidia (alogliptin) is a new DPP-4i for the management of Type 2 diabetes, launched in the UK with CV safety outcomes.1 Vipidia and the fixed dose combination product Vipdomet® (alogliptin and metformin) are now available in the UK. Vipidia is licensed for the treatment of Type 2 diabetes mellitus in adults aged 18 years and older to improve glycaemic control in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.2

The granting of the licence by the European Medicines Agency (EMA) is based on the results of a robust clinical trial programme including over 14,800 patients.1,2

CV disease accounts for 52 percent of fatalities in people with Type 2 diabetes.3 The results of the EXAMINE* safety trial of up to 40 months met its primary endpoint, demonstrating that Vipidia does not increase CV risk in Type 2 diabetes patients at high-risk for major adverse cardiac events (MACE) due to a recent acute coronary syndrome (ACS).1 In addition, no new safety signals were identified for Vipidia in EXAMINE.1

With the number of people with Type 2 diabetes rising dramatically in the UK,4 the NHS is increasingly feeling the strain of providing effective treatment options for the condition.4 The NHS currently spends an estimated £10 billion a year on treating diabetes (Type 1 and 2) and its complications,4 with the number of people with diabetes (Type 1 and 2) expected to rise to 5 million by 2025.4

Emeritus Professor of Medicine and Consultant Physician, Anthony Barnett (University of Birmingham and Heart of England NHS Foundation Trust, Birmingham, UK) commented “The EXAMINE trial was important as it assessed CV safety outcomes in patients with very high risk of cardiovascular disease (CVD), the leading cause of morbidity and mortality in the Type 2 diabetes patient population. Poorly controlled blood glucose continues to be a reality for many patients with Type 2 diabetes. Thus, given the demonstrated sustained glycaemic control, the good evidence for cardiovascular safety means that Vipidia offers the NHS significant value, and should make an important contribution to our therapeutic armamentarium in the UK”.

Results from the ENDURE study demonstrate that Vipidia 25 mg added-on to metformin offers superior durability of glycaemic control at two years with notably less hypoglycaemic episodes and significant reduction on weight compared to a sulphonylurea (SU) (glipizide) added-on to metformin.5 Results also show that Vipidia, when given in combination with metformin, can help significantly more patients (48.5%) achieve target HbA1c of ? 7% compared with an SU in combination with metformin (42.8%, p<0.01) at two years.5

Hiro Fukutomi, Managing Director at Takeda UK Ltd, added “Our launch marks an important milestone in Takeda’s ongoing commitment to advancing patient care in Type 2 diabetes and helping to meet the individual needs of the growing patient population, as well as continuing Takeda UK’s commitment to provide high quality new medicines which provide significant value to the NHS”.

The efficacy of Vipidia was also studied as an adjunct to diet and exercise as add-on therapy to several other classes of anti-diabetes medications, including metformin, pioglitazone, insulin and SUs. In these studies Vipidia 25 mg tablets taken once daily, demonstrated clinically and statistically significant reductions in HbA1c, with a good overall tolerability profile and a lower incidence of hypoglycaemia compared with active control or placebo.2 Generally, the effects of Vipidia on body weight were neutral.2

The EXAMINE trial’s primary objective was to evaluate non-inferiority of CV risk versus placebo based on a primary composite endpoint of CV death, nonfatal myocardial infarction and nonfatal stroke. The primary endpoint occurred at similar rates in the Vipidia and placebo groups (in 11.3% of patients vs. 11.8% of patients during a median follow-up period of 18 months; hazard ratio, 0.96; one-sided repeated confidence interval [CI] bound, 1.16).1

Vipidia is indicated for use and has doses available for patients at all stages of renal impairment, including End Stage Renal Disease (ESRD), although caution should be exercised with severe renal impairment (creatinine clearance < 30 mL/min) or ESRD requiring dialysis as data is limited in these patients.2

Source

1 White, W.B. et al. (2013) Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes. The New England Journal of Medicine. [Last accessed 04.02.14]

2 Summary of Product Characteristics for Vipidia, [Last accessed 04.02.14]

3 Morrish NJ, Wang SL, Stevens LK et al (2001). Mortality and causes of death in the WHO multinational study of vascular disease in diabetes. Diabetologia 44 suppl 2; s14–s21

4 Diabetes UK. (2012) State of the Nation 2012 England. [Last accessed 04.02.14]

5 Del Prato S, Camisaca R, Wilson C, Fleck P. Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide Over 2 Years When Used in Combination with Metformin. Poster presented at the 73rd Scientific Sessions of the American Diabetes Association (ADA), Chicago, Illinois, June 21-25, 2013. Poster #66-LB

Takeda Pharmaceutical Company Ltd