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 Pharmaceutical Benefits Scheme (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,’ Dr Roush said.

The latest edition of NPS RADAR reviews the medicine ezetimibe (Ezetrol) and a fixed-dose combined ezetimibe and simvastatin tablet (Vytorin).

People with certain conditions whose cholesterol levels are not controlled well enough by the cholesterol-lowering statin they are taking now are eligible for these medicines on the PBS. The conditions are coronary heart disease, diabetes, peripheral vascular disease, and familial hypercholesterolaemia.

‘The big question for consumers and their doctors to carefully consider is whether adding another drug is the best option,’ Dr Roush said. ‘If your treatment is working, there’s no need to add another drug.

‘Adding a second drug by using the combination tablet should be weighed against your treatment needs and the yet-to-be seen outcomes of the new fixed dose combination.

‘Compared to other medicines used to lower cholesterol, ezetimibe by itself or in combination tablet is a relatively new drug. This means that we don’t know all of the adverse effects or benefits of treatment yet.

‘If taking a statin by itself isn’t working as you and your doctor expected, check with your doctor to see if you are taking the tablets correctly.

‘Before thinking about changing your script, your doctor could review your dose or consider a statin other than the one you are taking. I don’t think this statement (re changing to another statin) is evidence-based and hence feel uncomfortable about it being included.

‘If ezetimibe is suitable for you, taking the two drugs separately means your doctor can change the dose of either tablet. If the dose of the combination tablet is appropriate for you, it may be more convenient to take, and it is cheaper than buying two tablets,’ Dr Roush said.

NPS RADAR concludes that the combination tablet could be considered for people who are already taking ezetimibe and a statin, or those who have tried statin treatment and still need their ‘bad’ cholesterol (low-density lipoprotein cholesterol or LDL-C) levels lowered.

The effect of the combination tablet is the same as taking the two drugs separately. The main effect of ezetimibe is to reduce LDL-C levels. It has little effect on ‘good’ cholesterol (high-density lipoprotein cholesterol or 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.