Vildagliptin(TM) More Effective In Type 2 Diabetes Management During Fasting Than The Most Commonly Prescribed Treatment

Main Category: Diabetes
Article Date: 18 May 2011 - 3:00 PDT


Data published today in Current Medical Research and Opinion show that Vildagliptin(TM) (a DPP-4 inhibitor) with metformin significantly reduces the incidence of hypoglycaemia, compared to the most commonly prescribed treatment combination, a sulphonylurea (SU) with metformin1. VECTOR* is the first and only real-life, prospective comparative study measuring the relative incidence of hypoglycaemia in Muslim people with Type 2 diabetes fasting during Ramadan (n=59). Data show that of those who received Vildagliptin and metformin, none experienced hypoglycaemic or severe hypoglycaemic events compared with 34 hypoglycaemic events, including one severe event, reported in 15 people receiving an SU and metformin (p=0.0002)1. Vildagliptin is the only DPP-4 inhibitor to have demonstrated efficacy and tolerability in a clinical trial in people with Type 2 diabetes who fast, a patient population which can be difficult to treat.

Type 2 diabetes is up to six times more common in people of South Asian descent2 compared to people of Caucasian decent and it is estimated that 325,000 Muslim people in the UK have diabetes3. Although health reasons exempt Muslim people with Type 2 diabetes from fasting during Ramadan, many still choose to fast. In a recent study of 12,243 Muslim people with diabetes from 13 countries, 79% of those with Type 2 diabetes reported fasting for at least 15 days during Ramadan4. This study also showed that fasting increased the risk of severe hypoglycaemia by 7.5 times in people with Type 2 diabetes4.

Professor Anthony Barnett, Professor of Medicine at The University of Birmingham and Consultant Physician and Clinical Director of Diabetes and Endocrinology at Heart of England NHS Foundation Trust, Birmingham, commented: "Despite the recommendation for Muslim patients with Type 2 diabetes not to fast during Ramadan, many patients choose to do so. When we consider the number of Muslims in the UK, around 1.6 million, it is critical that clinicians ensure that their Muslim patients with Type 2 diabetes are receiving the most appropriate treatment during this time. The real-life data from the VECTOR study show Vildagliptin with metformin is an effective treatment option with low risk of the unpleasant and sometimes devastating consequences of hypoglycaemia."

The VECTOR study also demonstrated that tolerability and adherence to treatment was markedly better in the Vildagliptin and metformin treated cohort than those treated with SU and metformin. In the Vildagliptin and metformin arm there were no adverse events (AEs) or serious adverse events reported by these patients and just four missed doses of treatment1. In contrast, 50% of those in the SU and metformin treated arm reported at least one AE and 266 missed doses1. Those treated with Vildagliptin and metformin also experienced a significantly lower HbA1c measurement, post-Ramadan (7.7% to 7.2%) versus those treated with an SU and metformin (7.2% to 7.3%) (p=0.0262)1. The study results also show that body weight remained unchanged in both groups1, which is of particular interest to people with Type 2 diabetes as some of the most commonly prescribed medications are associated with weight gain.

Medication dosing adjustments to help patients cope with fasting requirements during Ramadan are common. The VECTOR study revealed that 13.9% of people with Type 2 diabetes on an SU and metformin had their medication adjusted prior to Ramadan compared with none of those treated with Vildagliptin and metformin1. Treatment with Vildagliptin and metformin may therefore help to save precious clinician time and hospitalisation due to hypoglycaemic events.

The effects of hypoglycaemia can reduce health-related quality of life, cause vascular complications and it can even be fatal5. In the UK there are five fatal road traffic accidents each year and 45 serious events each month as a result of hypoglycaemia in patients taking insulin6. In addition to the burden on patients, severe hypoglycaemia in Type 2 diabetes has been estimated to cost the NHS an estimated £7.4 million annually7.

*VECTOR: Vildagliptin Experience Compared To gliclazide Observed during Ramadan

About Vildagliptin

Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for the treatment of Type 2 diabetes mellitus in combination with metformin, a sulphonylurea or a glitazone in patients with insufficient glycaemic control on the respective monotherapies.

Vildagliptin is available as a single 50mg tablet for prescription in combination with metformin, a sulphonylurea or a glitazone. It is also available as a single Vildagliptin/metformin combination tablet (50mg/850mg and 50mg/1000mg), the only combination offering flexible metformin dosing.

Vildagliptin is not licensed for use as a monotherapy.

Safety data for Vildagliptin were obtained from clinical trials with a total of 3,784 patients8. The majority of adverse reactions in these trials were mild and transient and did not require treatment discontinuations8. No association was found between adverse reactions and age, ethnicity, duration of exposure of daily dose8.

Rare cases of hepatic dysfunction (including hepatitis) have been reported8. In these cases the patients were generally asymptomatic without clinical sequelae and liver function returned to normal after discontinuation of treatment8.

In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of persistent ALT or AST elevations ≥3xULN was: Vildagliptin 50mg o.d 0.2%, Vildagliptin 50mg b.d 0.3% and all comparators 0.2%8. These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice8.

Rare cases of angioedema have been reported on Vildagliptin at a similar rate to controls8.

References

1. Hassanein M, et al. Curr Med Res & Opin 2011: 27: 1367-1374. Epub ahead of print: doi 10.1185/03007995.2011.579951

2. Department of Health. National service framework for diabetes. 2001 See here. Accessed April 2011

3. Karamat MA, et al. JR Soc Med. 2010: 103:139-147

4. Salti I, et al. Diab Care 2004: 27: 2306-2311

5. Barnett AH, et al. Int J Clin Pract. 2010:. Epub ahead of print

6. Hitchen L.,BMJ. 2006: 332: 812-813

7. Amiel SA, et al. Diabetic Medicine. 2008: 25: 245-254

8. Vildagliptin Summary of Product Characteristics. Jan 2011

Source:
Novartis

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