CG87 Type 2 diabetes - newer agents (a partial update of CG66): NICE guideline (MS Word format)
In September 2010 the European Medicines Agency (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 Therefore, as a result of the EMA's decision, NICE has temporarily withdrawn its recommendations on the use of rosiglitazone in this guideline.
Clarification: recommendation 188.8.131.52 NICE guideline
This wording should not be read as implying that treatment might be aimed at achieving a low HDL cholesterol level. The intention here is to set limits for the validity of total cholesterol level measurement, not to set any kind of target for HDL cholesterol, which is usually regarded as protective against cardiovascular disease. Total cholesterol measurement is problematic as it includes HDL cholesterol, and so can be elevated by higher levels of HDL cholesterol. In these circumstances, treatments aimed at lowering total cholesterol further are not indicated and LDL cholesterol levels should be used to assess the results of lipid-lowering treatments.
MHRA advice on aspirin
The Medicines and Healthcare products Regulatory Authority (MHRA) Drug safety update (Volume 3, Issue 3, October 2009) gives the following advice on using aspirin for the primary prevention of vascular events, which is relevant to recommendations 1.11.1 and 1.11.2 in the NICE guideline:
Aspirin is not licensed for the primary prevention of vascular events. If aspirin is used in primary prevention, the balance of benefits and risks should be considered for each individual, particularly the presence of risk factors for vascular disease (including conditions such as diabetes) and the risk of gastrointestinal bleeding.
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This page was last updated: 22 August 2011