Acipimox not suitable first line for high triglycerides
Acipimox should only be used to reduce high triglyceride levels when other measures are not effective, EU medicines regulators have decided after reviewing available data.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh) is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU. It has endorsed earlier recommendations from the European Medicines Agency which proposed that medicines containing acipimox should have their marketing authorisations amended.
Acipimox is suitable for treating hypertriglyceridaemia with or without hypercholesterolaemia when changes in lifestyle, including diet and exercise, and treatment with other medicines, such as fibrates and statins, are not adequate. Prescribers should also be aware of a potential increased risk of myopathy when acipimox is used together with a statin.
The review of data came about because acipimox is structurally related to nicotinic acid, which had been linked to serious side effects when used with laropiprant for lipid disorders in combination with statins.
Patients taking acipimox should have their treatment reviewed at their next regular appointment, the EMA recommends.
CMDh decisions require ratification by the European Commission to make them legally binding across the EU.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11132592
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