Drug significantly cuts hypoglycemic events

MANILA, Philippines - A newly published study showed that the Novartis oral diabetes medication vildagliptin, when taken with metformin, caused no hypoglycemia, was well adhered to and improved blood sugar levels in South Asian patients with type 2 diabetes mellitus (T2DM) fasting during daylight hours for Ramadan.

Diabetes medications are the primary cause of hypoglycemia in T2DM. This increased hypoglycemia risk becomes even more pertinent in patients who eat irregularly or miss meals, such as during fasting.

Hypoglycemia occurs when blood glucose drops below normal levels. It is a major barrier to treatment adherence, adversely affects quality of life and can cause emotional distress and vascular complications. In severe cases, it can even be fatal.

An overall mortality (death) rate of approximately nine percent has been seen in cases of severe hypoglycemia induced by sulfonylurea (SU) monotherapy. The cost of hospital admissions due to severe hypoglycemic events is substantial.

The American Diabetes Association recommends exercising caution on the use of SUs in its recommendations for the management of T2DM during Ramadan.

Published in the July 2011 issue of Current Medical Research and Opinion, the VECTOR study (Vildagliptin Experience Compared To gliclazide Observed during Ramadan) compared vildagliptin and metformin with SU and metformin in a real-world setting of 59 fasting South Asian Muslim patients.

Of those patients in the study who received vildagliptin + metformin, none experienced a hypoglycemic event compared with 41.7 percent of patients receiving SU + metformin.

There was a marked difference in treatment adherence between groups. Only one patient in the vildagliptin + metformin group missed at least one dose of treatment compared with 10 in the SU group.

In addition, those treated with vildagliptin + metformin experienced a significantly lower HbA1c measurement post-Ramadan versus those treated with SU + metformin.

While there were no adverse events (AEs) or serious AEs reported with vildagliptin + metformin, 18 patients (50 percent) in the SU + metformin group reported at least one AE. The main driver for the difference was the high incidence of hypoglycemia in the SU + metformin group (15 patients or 41.7 percent). Body weight remained unchanged in both groups. 

VECTOR’s authors explained that although the study was relatively small, when extrapolated to the global Muslim population with a similar clinical background, its findings could have considerable public health and clinical implications.

Worldwide, 40 million to 50 million Muslims with diabetes fast during Ramadan. An annual month of fasting for Muslims, Ramadan in 2011 began on or around Aug. 1 and will end on or around Aug. 30 (Eid al-Fitr).

VECTOR builds on previous research in this particular type of patients. In a recent study of 11,173 Muslim patients with T2DM, 79 percent reported fasting for at least 15 days during Ramadan. The same study also showed that fasting increased the risk of severe hypoglycemia by 7.5 times in people with T2DM.