Food for Thought: IQWiG Says Benefit Of Ezetimibe Not Proven

Various studies have demonstrated that lowering cholesterol levels with statins is preventing heart attacks and other cardiovascular complications. However, some patients do not tolerate statins or do not achieve recommended cholesterol levels with statins alone. These patients often are prescribed ezetimibe (sold as Ezetrol by MSD Sharp & Dohme in Germany), an oral cholesterol-absorption inhibitor, either alone or in combination with statins. A fixed combination of ezetimibe with statin simvastatin is sold as Inegy.

Last year, Germany’s Federal Joint Committee (G-BA) which is deciding about drug reimbursements for the country’s statutory healthcare system, commissioned Germany’s cost-benefit watchdog IQWiG to assess the benefit of ezetimibe either alone or as combination therapy.

IQWiG published its report earlier this month. While it not disputes that ezetimibe is lowering cholesterol levels, the institute states in its report that it has been unable to identify any review or study demonstrating that the prescription of ezetimibe alone or in combination does provide patient-related benefits in terms of reducing “all-cause” or “vascular” mortality.

However, new data and findings supporting the benefit of ezetimibe will be available soon.  Pulse Magazine, a leading medical weekly in the UK, reported Sept. 2 that researchers looked into the effectiveness of ezetimibe in combination with statins on all-cause mortality over a period of 4.3 years. They concluded that the combination treatment – if used after a myocardial infarction – resulted in a 55% decrease in all-cause mortality compared to patients taking simvastatin alone. The trial was a retrospective study on a cohort of nearly 15,000 patients from the UK’s General Practice Research Database. The researchers already had announced a presentation of the results at the European Society of Cardiology Congress in Paris end of August, but cancelled the presentation to perform a more complex analysis of the data.