FRIMLEY, England, April 23 /PRNewswire/ --
- Vildagliptin a new treatment for type 2 diabetes reduces HbA1c (the gold standard measure of blood sugar control) by an additional 1.1% versus placebo when added to metformin1 (the standard first line treatment for type 2 diabetes).
- Vildagliptin use does not cause weight gain and is associated with a low incidence of hypoglycaemia and gastrointestinal side effects comparable to placebo, when added to metformin in clinical trials(1).
- Vildagliptin is available both alone (as an add-on therapy) and in a combination tablet with metformin, offering physicians prescribing flexibility and convenience for patients
Vildagliptin, a new oral treatment for patients with type 2 diabetes is now available in the UK. Vildagliptin demonstrated additional reductions in HbA1c of 1.1% versus placebo when added to metformin(1). In metformin treated patients (baseline HbA1c over 9%) the addition of Vildagliptin reduced HbA1c by an additional 1.5%(2).
As reported in the United Kingdom Prospective Diabetes Study (UKPDS) which assessed conventional antidiabetic therapies, every 1% reduction in HbA1c is important as it reduces the risk of diabetes related death by 21%, heart attack by 14% and microvascular complications by 37%(3). One in 3 patients on metformin monotherapy continue to have uncontrolled diabetes (>7.5% HbA1c)(4).
Weight gain is a common side effect of traditional add-on type 2 diabetes therapies(5,6,7). Unlike other conventional add-on treatments (glitazones and sulphonylureas), Vildagliptin in combination with metformin has been shown not to increase mean body weight in clinical trials and in contrast to sulphonylureas, is associated with a low incidence of hypoglycaemia(1,5,6,8,9). In addition, when added to metformin in clinical studies, Vildagliptin has an overall gastrointestinal side effect profile that is comparable to placebo(1,9).
"Around 80% of people diagnosed with type 2 diabetes are overweight and it is a real concern that the treatments they need to take to control their blood sugar can lead to added weight gain" said Dr Eugene Hughes, GP, Isle of Wight. "As an effective treatment without weight gain when used in combination with metformin in clinical trials, Vildagliptin offered a potential solution to this very real problem."
Vildagliptin works by targeting islet dysfunction, helping to restore the body's natural ability to increase insulin and decrease glucagon - the two main hormones controlling blood sugar levels(10). When blood glucose levels rise, Vildagliptin enhances the appropriate production of insulin by the pancreatic beta cells and decreases production of glucagon by pancreatic alpha cells, resulting in improved glycaemic control(11,12). Most other classes of type 2 diabetes medicines work by targeting either insulin resistance or stimulating insulin secretion(11,12,13).
Vildagliptin is available both alone and in a combination tablet with metformin. Used together, Vildagliptin and metformin address the two major causes of type 2 diabetes - islet dysfunction and insulin resistance(10,13).
Dr Marc Evans, Consultant Diabetologist, Llandough Hospital, Cardiff, highlights the importance of this advance: "Vildagliptin helps the body respond appropriately to blood glucose levels. It offers a promising treatment for the significant proportion of patients whose blood sugar levels are above target levels and are therefore at risk of microvascular and macrovascular complications."
Vildagliptin has been studied extensively in over 10,000 patients worldwide across diverse patient populations including patients of different ethnicity and varying age groups.
Vildagliptin is expected to be prescribed mainly for:
- dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite on maximal tolerated dose of monotherapy with metformin(9)
But also has a license for use in(9):
- dual oral therapy in combination with a sulphonylurea, where patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance
- dual oral therapy with a glitazone in patients with insufficient glycaemic control and for whom the use of a glitazone is appropriate
Vildagliptin is marketed in the UK by Novartis Pharmaceuticals UK Ltd.
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
References 1) Bosi E et al. Diabetes Care 2007;30(4):890-895 2) Bolli G et al. Diab Obes Metab 2008;10(1):82-90 3) Stratton IM et al. BMJ 2000; 321:405-412 4) CSD Patient Data, Cegedim Strategic Data UK Ltd. April 2006 5) Pioglitazone Summary of Product Characteristics 6) Rosiglitazone Summary of Product Characteristics 7) Krentz AJ, Bailey CJ. Drugs 2005;65(3):385-411 8) Bolen S et al. Ann Intern Med 2007 9) Vildagliptin Summary of Product Characteristics 10) Henness S, Keam SJ. Drugs 2006;26:360-374 11) Triplitt C Pharmacotherapy 2006;26:360-374 12) Drucker DJ, Nauck MA Lancet 2006;368(11):1696-1705 13) Krentz AJ, Bailey CJ. Drugs 2005;65(3):385-411
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