A new indication and NICE guidance for ezetimibe
Ezetimibe (Ezetrol®), which is used to treat hypercholesterolaemia in combination with a statin, has been granted a new indication by the Medicines and Healthcare products Regulatory Agency (MHRA). The drug is now also indicated to reduce the risk of cardiovascular events in patients with coronary heart disease and a history of acute coronary syndrome when added to ongoing statin therapy or started with a statin.
Dr Mark Signy, a consultant cardiologist at Western Sussex Hospitals Trust commented “Many patients with coronary heart disease continue to have cardiovascular events, even when managed with statins at higher doses and with conventionally ‘low’ LDL-C levels. The new licence extension reinforces the importance of ezetimibe as a useful addition to everyday treatment of cardiovascular disease, especially for those patients at higher risk”.
In a separate announcement, NICE has issued Technology Appraisal Guidance (TAG) for ezetimibe in treating primary heterozygous-familial and non-familial hypercholesterolaemia. The TAG recommends ezetimibe on its own as an option in adults where initial statin therapy is contraindicated or not tolerated, and in combination with statin therapy when their cholesterol level is not controlled after initial statin dose increase or when there is potential for side-effects with higher statin doses.
Both the updated licence indication and the NICE guidance were based on outcomes from the IMPROVE-IT trial involving more than 18,000 patients, which demonstrated that ezetimibe was the first non-statin cholesterol-lowering medication to show additional benefit in decreasing the risk of CV events when added to a statin.
For more information, the ezetimibe SmPC can be found at: http://www.medicines.org.uk/emc/medicine/12091.5