The U.K. National Institute for Health and Clinical Excellence (NICE) has issued new guidelines on cholesterol-lowering regimens combining ezetimibe with a statin.

The new guidelines recommend ezetimibe for use in combination with a statin in patients whose cholesterol levels remain above national targets, even with a low cholesterol diet and after initial statin therapy has been titrated appropriately, and in situations in which a change to alternative statin has been considered.

Michael Livingston, Director of H.E.A.R.T. UK commented "Over one third of the 2.6 million people in the U.K. with coronary heart disease are not reaching government cholesterol targets (5 mmol/L) and are at significant risk of heart attack and stroke. We are therefore delighted by the publication of the NICE guidance on ezetimibe. This approach to managing high cholesterol could benefit thousands of people."

The U.K. national guidelines recommend a total cholesterol target of less than 5 mmol/L and a low-density-lipoprotein cholesterol target of less than 3 mmol/L. However, despite the availability of effective medications, about 35 percent of patients with coronary heart disease are not reaching target levels after initial therapy.

The authors note that just a 1 mmol/L reduction in low-density cholesterol is associated with a 23 percent reduction in the 5-year incidence of a first major coronary event such as myocardial infarction.

Before updating their recommendations, the NICE Guidance Committee considered clinical evidence that showed adding ezetimibe to statin therapy reduced low-density cholesterol by 23.2 percent more than statin therapy alone. This is compared with reductions of roughly 6 percent and 8 percent for doubling the dose of statin therapy or switching to an alternative statin.

The Guidance Committee defined intolerance to statin therapy as the presence of clinically significant adverse effects from statin therapy that are thought to represent an unacceptable risk to the patient or that may result in noncompliance with therapy. The guidelines state that therapy with ezetimibe coadministered with a statin was found to have a similar adverse event profile to that of statin therapy alone.