Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
Lescol (Sandoz Australia)
20 mg and 40 mg capsules
Indication: hypercholesterolaemia
This product is an addition to the class of drugs which inhibit hydroxymethyl glutaryl coenzyme A and thereby reduce cholesterol synthesis.1 The class also includes simvastatin and pravastatin.
Fluvastatin is well absorbed and extensively metabolised by the liver. The bioavailability is approximately 24%. Most of the metabolites are excreted in the faeces and the elimination half life is 2-3 hours. The manufacturer recommends that liver function tests are performed before and during therapy. If the liver enzyme concentrations persistently exceed 3 times the upper limit of normal, therapy should be stopped.
The drug reduces total cholesterol and low density lipoprotein cholesterol while slightly increasing concentrations of high density lipoprotein cholesterol. This means it is suitable for the treatment of hyperlipidaemia when hypercholesterolaemia predominates. Fluvastatin should be considered if other treatments including diet are unsatisfactory. Dietary therapy must continue during fluvastatin treatment.
The most common adverse effects are dyspepsia, nausea and insomnia. It is not known if fluvastatin can cause the myopathic syndromes which have been observed in patients taking similar drugs. There are no long term safety data available.
Fluvastatin may be less effective at lowering the concentration of cholesterol than other reductase inhibitors, so its price may determine how frequently it is prescribed. A review in the U.S.A. concluded that fluvastatin may be less effective in lowering serum cholesterol, but costs less than other HMGCoA reductase inhibitors.2
