NPC Archive Item: Vildagliptin launch delayed

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.
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The European launch of vildagliptin (Glavus®) has been delayed by a safety update according to PharmaTimes. Pooled safety data shows more frequent liver enzyme elevations with the 100mg once daily dose than with either 50mg daily or twice a day. As a result Novartis is no longer seeking approval of the 100mg once a day dose

Vildagliptin and sitagliptin▼ (Januvia▼®) are a newly introduced class of drug treatment for glycaemic control in type 2 diabetes. They increase levels of incretin hormones, which are involved in the physiologic regulation of glucose homeostasis. The NPC produced an On The Horizon Future Medicines newsletter on sitagliptin and vildagliptin for type 2 diabetes in December 2006. An update to the evidence around sitagliptin was published after it was launched in April 2007 (Both these documents have now been removed from our website as the information is no longer up-to-date).

So what? Sitagliptin▼ has been launched and is licensed in combination with metformin or a glitazone for patients with type 2 diabetes, to improve glycaemic control when diet and exercise, plus metformin or a glitazone alone do not provide adequate control. However, there is as yet no evidence concerning the effectiveness of sitagliptin in preventing long term complications of type 2 diabetes, diabetes-related mortality or total mortality. Although control of blood glucose is important for managing symptoms in diabetes and reducing some microvascular complications, the UKPDS study showed that in type 2 diabetes tight control of blood glucose with insulin or sulphonylureas does not reduce the risk of macrovascular complications (heart attacks, strokes, etc) or most serious microvascular complications (such as kidney failure, blindness, etc). This is explored more fully on the Type 2 Diabetes floor of NPCi. As we blogged recently, the Medicines and Healthcare products Regulatory Agency have announced the outcome of a Europe wide safety review of the glitazones.

Action: The gliptins are new agents and they should be reserved for use when diet and exercise combined with other agents alone have failed to adequately control blood glucose or are not tolerated.

This article is based on a blog by Matt Robinson and can be accessed at