NICE clinical guideline 87 partially updates NICE clinical guideline 66 and replaces it. Most of the recommendations were developed for NICE clinical guideline 66 by the National Collaborating Centre for Chronic Conditions.
Details of the methods and evidence used to develop these recommendations are in CG66 Type 2 diabetes: full guideline. The recommendations on DPP-4 inhibitors (sitagliptin, vildagliptin), thiazolidinediones (pioglitazone, rosiglitazone), exenatide and insulin were developed by the Centre for Clinical Practice at NICE following the process for short clinical guidelines.
Details of the methods and evidence used to develop these recommendations are in CG87 Type 2 diabetes - newer agents: short guideline.
This guidance updates and replaces NICE inherited clinical guideline E (published in February 2002), NICE inherited clinical guideline F (published in February 2002). NICE inherited clinical guideline G (published in September 2002) and NICE inherited clinical guideline H (publsihed in October 2002).
The European Medicines Agency (EMA) and rosiglitazone
In September 2010 the EMA, the European Union (EU) body responsible for monitoring the safety of medicines, recommended the suspension of the marketing authorisation for rosiglitazone (Avandia, Avandamet and Avaglim) from GlaxoSmithKline. The EMA has concluded that the benefits of rosiglitazone no longer outweigh its risks and the marketing authorisation should be suspended across the EU.
The EMA has advised that patients who are currently taking rosiglitazone-containing medicines should make an appointment with their doctor at a convenient time to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor. NICE does not recommend the use of drugs without marketing authorisation. Therefore, as a result of the EMA's decision, NICE has temporarily withdrawn its recommendations on the use of rosiglitazone in this guideline.
There is an incomplete sentence in R32 of the full guideline. The recommendation should read
Consider a sulfonylurea as an option for first-line glucose-lowering therapy if:
- the person is not overweight
- the person does not tolerate metformin (or it is contraindicated) or
- a rapid response to therapy is required because of hyperglycaemic symptoms
MHRA and Rosiglitazone
On 26th. July 2010, the Medicines and Healthcare products Regulatory Agency published a statement of their current advice and information about the use of rosiglitazone (Avandia, Avandamet) in the treatment of diabetes.
The summary states " In view of the evidence of cardiovascular risk with rosiglitazone our (MHRA) advice to healthcare professionals is to closely observe the current contraindications, warnings and precautions and monitoring requirements, and to consider alternative treatments where appropriate"
A Europe-wide review of available data on the risks and benefits of rosiglitazone by the European Committee on Medicinal Products for Human Use (CHMP) started on 9 July and is anticipated to be completed by September 2010.