LORSTAT

What it is

LORSTAT contains atorvastatin calcium trihydrate and is available in 10 mg, 20 mg, 40 mg and 80 mg tablet strengths. LORSTAT tablets are white to off-white, elliptical, film-coated tablets. Atorvastatin is a synthetic lipid-lowering agent and an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of sterols, including cholesterol.

Approved indications

— Treatment of patients with hypercholesterolaemia as an adjunct to diet. — Reduction of the risk of non-fatal myocardial infarction and non-fatal stroke in hypertensive patients with multiple risk factors for coronary heart disease, which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic coronary heart disease.

Dosing overview

LORSTAT can be administered within the dosage range of 10 mg to 80 mg per day as a single daily dose. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy and the patient's response. The majority of patients with primary hypercholesterolaemia and mixed dyslipidaemia are controlled with 10 mg atorvastatin once a day, with a therapeutic response evident within two weeks and maximum response usually achieved within four weeks. Atorvastatin can be taken at any time of the day, with or without food.

Key safety warnings

Moderate elevations of serum transaminases have been reported following therapy with atorvastatin, with persistent increases in serum transaminases greater than three times the upper limit of normal occurring in 0.7% of patients in clinical trials, with an incidence of 0.2%, 0.2%, 0.6% and 2.3% for 10 mg, 20 mg, 40 mg and 80 mg doses respectively. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Uncomplicated myalgia has been reported in atorvastatin-treated patients. Myopathy, defined as muscle ache or muscle weakness in conjunction with increases in creatine kinase values greater than ten times the upper limit of normal, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and marked elevation of creatine kinase. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin therapy should be discontinued if markedly elevated creatine kinase levels occur or if myopathy is diagnosed or suspected. Atorvastatin must not be co-administered with fusidic acid, as there have been reports of rhabdomyolysis (including some fatalities) in patients receiving concomitant fusidic acid and statins. A post-hoc analysis of the SPARCL clinical study in patients without known coronary heart disease who had a recent stroke or transient ischaemic attack showed a higher incidence of haemorrhagic stroke in patients on atorvastatin 80 mg compared to placebo, with the increased risk observed in patients who entered the study with prior haemorrhagic stroke or prior lacunar infarct.

Contraindications

LORSTAT is contraindicated in patients with hypersensitivity to any component of the medication, active liver disease or unexplained persistent elevations of serum transaminases, pregnancy and lactation. Women of childbearing potential must be on an effective contraceptive and highly unlikely to conceive. LORSTAT is also contraindicated with concomitant use of fusidic acid hemihydrate and with treatment with the Hepatitis C antivirals glecaprevir/pibrentasvir.

PBS listing

No information regarding PBS listing is available in the provided source documents.

Regulatory history

LORSTAT 10 mg, 20 mg, 40 mg and 80 mg tablets in blister pack and bottle formats were first listed on the Australian Register of Therapeutic Goods on 18 August 2020.