31 March 2006

Heralded in the media as a breakthrough new medicine for treating high cholesterol, the combined ezetimibe and simvastatin (Vytorin) tablet is neither, Dr Peter Roush, of NPS, said.

‘Simvastatin has been available on the PBS since the early 1990s, while ezetimibe was listed in August 2004, meaning doctors have been able to use them in combination for some time now.

‘Doctors should carefully consider the pros and cons of combination products,’ he said.

‘The key question is whether adding another drug is the best option for the patient. If statin monotherapy isn’t working as expected, doctors should check patient compliance before changing the script.

‘Use of the combination tablet should be weighed against the patient’s treatment needs and the yet-to-be seen outcomes of the new fixed dose combination.’

‘There is no need to consider adding ezetimibe for patients who have reached lipid goals and are tolerating statin monotherapy. An alternative to adding a second drug is to consider the appropriateness and dose of the statin used.’

Dr Roush said that compared to many cholesterol-lowering drugs, ezetimibe is relatively new, and that the full adverse effect profile or the benefits of treatment with this fixed-dose combination tablet are not fully known as yet.

He spoke as the latest edition of NPS RADAR, which covers the two new indications for ezetimibe (Ezetrol) and a combined ezetimibe and simvastatin tablet (Vytorin) on the PBS, was released. The article complements a more extensive review released just last month.

People with heterozygous familial hypercholesterolaemia or peripheral vascular disease whose cholesterol levels are inadequately controlled despite treatment with a statin are now eligible for these products on the PBS. People with coronary heart disease and diabetes have been able to access these tablets on the PBS since 1 March 2006.

According to NPS RADAR, the combination tablet could be considered for patients already taking ezetimibe and a statin, or those who need their low-density lipoprotein cholesterol (LDL-C) levels lowered and for whom adding ezetimibe is an appropriate choice.

The effect of ezetimibe with simvastatin tablets is equivalent to the two drugs co-administered separately. The main effect of ezetimibe is to reduce LDL-C levels. It has little effect on high-density lipoprotein cholesterol (HDL-C) or triglyceride levels.

NPS RADAR provides independent information about new medicines and changes to PBS listings important to GPs, pharmacists and other health professionals involved in primary care management of patients. To receive NPS RADAR go to www.npsradar.org.au.

National Prescribing Service Limited (NPS) is a member-based organisation providing accurate, balanced, evidence-based information and services to health professionals and the community on Quality Use of Medicines (QUM). To achieve this we work in partnership with GPs, pharmacists, specialists, other health professionals, Government, pharmaceutical industry, consumer organisations and the community.