Atorvastatin

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Atorvastatin on Prescriptsy

Atorvastatin is described on Prescriptsy as independent product information.

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Atorvastatin is the most widely prescribed statin in the United Kingdom, used to lower LDL cholesterol and reduce the risk of cardiovascular events including heart attack, stroke and cardiovascular death.

It belongs to the HMG-CoA reductase inhibitor class and works by blocking the enzyme responsible for cholesterol production in the liver.

Atorvastatin is recommended by NICE for both primary prevention in people at elevated cardiovascular risk and secondary prevention in those with established cardiovascular disease.

Cardiovascular disease remains the leading cause of death in the UK, accounting for approximately 160,000 deaths annually. Raised LDL cholesterol is one of the strongest modifiable risk factors.

Large-scale clinical trials including the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) and the Collaborative Atorvastatin Diabetes Study (CARDS) have demonstrated that atorvastatin significantly reduces cardiovascular events in both primary and secondary prevention populations.

NICE guideline CG181 recommends offering atorvastatin 20mg to adults with a 10-year cardiovascular risk of 10% or greater, and atorvastatin 80mg to those with established cardiovascular disease.

This product information has been reviewed by Dr. Claire Phipps, MBBS MRCGP (GMC 7014359), and provides a comprehensive clinical overview of atorvastatin covering its pharmacology, indications, dosing, monitoring requirements, side effects, important interactions and practical guidance for UK patients.

Essential safety information about atorvastatin

Atorvastatin should not be taken during pregnancy or breastfeeding. Statins are teratogenic and can cause serious harm to a developing baby. Women of childbearing potential must use effective contraception throughout treatment. Three situations require prompt medical attention while taking atorvastatin:

• Unexplained muscle pain, tenderness or weakness, especially if accompanied by fever, malaise or dark-coloured urine, this may indicate rhabdomyolysis, a rare but serious condition requiring urgent assessment
• Yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, or persistent right upper abdominal pain, possible signs of liver injury
• Severe allergic reaction including facial swelling, difficulty breathing, or widespread rash, call 999 immediately

Atorvastatin is a prescription-only medicine (POM). Treatment decisions are based on cardiovascular risk assessment, lipid profiles and individual patient factors.

Do not stop taking atorvastatin without discussing it with your prescriber, as this will allow cholesterol levels to rise and increase cardiovascular risk.

Always read the patient information leaflet supplied with your medicine.

How atorvastatin works

Atorvastatin inhibits 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the enzyme that catalyses the rate-limiting step in hepatic cholesterol biosynthesis.

By reducing intracellular cholesterol production, atorvastatin triggers upregulation of LDL receptor expression on hepatocyte surfaces, which increases the uptake and clearance of LDL cholesterol from the bloodstream.

The lipid-lowering effects are dose-dependent. At 10mg, atorvastatin typically reduces LDL cholesterol by approximately 37%.

At 20mg the reduction is around 43%, at 40mg approximately 49%, and at the maximum dose of 80mg, reductions of 50-55% are achievable.

Atorvastatin also reduces total cholesterol by 25-45%, triglycerides by 17-33%, and raises HDL (good) cholesterol by 5-9%.

These effects become apparent within 2 weeks of starting treatment, with maximum effect at 4 to 6 weeks.

Atorvastatin is well absorbed after oral administration and undergoes extensive first-pass metabolism by cytochrome P450 3A4 (CYP3A4) in the liver.

It has an elimination half-life of approximately 14 hours, but its active metabolites extend the duration of HMG-CoA reductase inhibition to 20-30 hours.

This prolonged activity means atorvastatin can be taken at any time of day, unlike simvastatin which is preferably taken in the evening.

Who should take atorvastatin

Primary prevention

NICE guideline CG181 recommends offering atorvastatin 20mg daily to adults assessed as having a 10-year cardiovascular risk of 10% or more using the QRISK3 tool.

This includes many patients with type 2 diabetes, chronic kidney disease (stages 3-5), or familial hypercholesterolaemia.

Primary prevention means reducing the risk of a first cardiovascular event in people who have not yet had a heart attack or stroke.

The decision to start a statin should be made jointly with the patient after discussing the benefits, risks, and lifestyle measures including diet and exercise.

Secondary prevention

For patients with established cardiovascular disease, including those who have had a myocardial infarction, ischaemic stroke, transient ischaemic attack, peripheral arterial disease, or who have undergone coronary revascularisation, NICE recommends atorvastatin 80mg daily.

If 80mg is not tolerated, the highest tolerated dose should be used.

Secondary prevention is one of the most evidence-based interventions in cardiovascular medicine, with statin therapy reducing the risk of further events by approximately 25-35%.

Familial hypercholesterolaemia

Atorvastatin at high doses (40-80mg) is a first-line treatment for heterozygous familial hypercholesterolaemia (FH), a genetic condition affecting approximately 1 in 250 people in the UK.

Patients with FH have markedly elevated LDL cholesterol from birth and face a significantly increased lifetime risk of premature coronary heart disease.

Treatment should be initiated as soon as the diagnosis is confirmed, including in children and adolescents under specialist supervision.

Dosing and administration

Atorvastatin is available as 10mg, 20mg, 40mg and 80mg film-coated tablets.

The starting dose depends on the clinical indication: 20mg for primary prevention, up to 80mg for secondary prevention or FH.

Dose adjustments should be made at intervals of at least 4 weeks based on lipid response, aiming for at least a 40% reduction in non-HDL cholesterol from baseline.

The tablet is taken once daily at any time, with or without food. Consistency of timing helps with adherence.

If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next dose.

A double dose should never be taken.

For patients who have difficulty swallowing tablets, atorvastatin may be dispersed in water, though this is an unlicensed method that should be discussed with the prescriber.

Dose reduction may be necessary when atorvastatin is co-prescribed with interacting drugs that increase its plasma concentration, such as ciclosporin (maximum atorvastatin 10mg), or with moderate CYP3A4 inhibitors.

The BNF provides detailed interaction guidance. Liver function tests should be checked before initiation, at 3 months and 12 months, and then only if clinically indicated.

There is no requirement for routine dose adjustment in mild to moderate renal impairment, as atorvastatin is primarily eliminated by hepatic metabolism.

Side effects of atorvastatin

Common side effects

The majority of patients tolerate atorvastatin well. The most frequently reported side effects, affecting up to 1 in 10 users, include:

• Musculoskeletal: myalgia (muscle aches), arthralgia (joint pain), back pain, and muscle spasm
• Gastrointestinal: nausea, flatulence, dyspepsia, diarrhoea, constipation, and abdominal pain
• Neurological: headache, dizziness, and paraesthesia (tingling sensation)
• Respiratory: nasopharyngitis (common cold symptoms) and pharyngolaryngeal pain

Muscle-related adverse effects

Muscle symptoms are the most clinically significant side effects of all statins.

The spectrum ranges from mild myalgia (common, affecting approximately 5-10% of patients) to myopathy with creatine kinase elevation and, very rarely, rhabdomyolysis with acute kidney injury.

Risk factors for severe muscle toxicity include high statin dose, advanced age, female sex, small body frame, renal impairment, hypothyroidism, excess alcohol intake, and concurrent use of drugs that increase statin exposure (fibrates, macrolides, azole antifungals, ciclosporin, HIV protease inhibitors).

If you develop unexplained, persistent or worsening muscle pain, tenderness or weakness, contact your GP promptly.

Creatine kinase measurement and clinical assessment will determine whether atorvastatin should be continued, dose-reduced or stopped.

In many cases, muscle symptoms resolve on re-challenge with a lower dose or an alternative statin, and the cardiovascular benefits of statin therapy typically outweigh the risks.

Other notable adverse effects

New-onset type 2 diabetes has been associated with statin use, particularly at higher doses and in patients already at risk of diabetes.

Meta-analyses suggest the absolute risk is approximately 1 additional case per 1,000 patient-years of treatment.

NICE guidance states that the cardiovascular benefits substantially outweigh this risk and statin therapy should not be withheld on this basis.

Rarely reported effects include elevated liver transaminases (usually transient and asymptomatic), alopecia, memory impairment, sexual dysfunction, interstitial lung disease, and tendon disorders. Report any suspected side effects to the MHRA via the Yellow Card Scheme at yellowcard.mhra.gov.uk.

Important warnings and drug interactions

Atorvastatin is contraindicated in active liver disease, unexplained persistent transaminase elevation exceeding 3 times the upper limit of normal, pregnancy, breastfeeding, and in women not using adequate contraception. The following drug interactions are of particular clinical importance:

• Ciclosporin: atorvastatin dose must not exceed 10mg daily due to markedly increased statin exposure
• Fusidic acid (systemic): statin must be temporarily stopped during fusidic acid courses due to high rhabdomyolysis risk, this interaction has caused fatalities
• Clarithromycin, erythromycin, itraconazole, ketoconazole: CYP3A4 inhibitors that increase atorvastatin levels, lower statin doses may be needed
• HIV protease inhibitors (ritonavir, lopinavir, tipranavir): significant increases in statin exposure requiring dose limitations
• Fibrates, particularly gemfibrozil: increased risk of myopathy when combined with statins
• Warfarin: atorvastatin may enhance anticoagulant effect, INR monitoring advisable when starting or changing statin dose

Grapefruit juice in large quantities (more than approximately 1.2 litres daily) can significantly increase atorvastatin plasma levels. Small amounts are unlikely to be clinically relevant.

Patients should inform their prescriber and pharmacist of all current medicines, including herbal products such as St John's wort (which may reduce statin efficacy by inducing CYP3A4).

Monitoring and follow-up

Before starting atorvastatin, your GP will check a full lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides) and liver function tests (ALT or AST).

A baseline HbA1c and renal function test are also recommended. The treatment target is a greater than 40% reduction in non-HDL cholesterol from the pre-treatment baseline.

Follow-up blood tests are typically performed at 3 months to assess response.

If the 40% reduction target is not met, adherence should be confirmed, lifestyle factors reviewed, and dose increase considered. Annual lipid profiles and clinical review are standard thereafter.

Routine CK measurement is not recommended unless the patient develops muscle symptoms.

If muscle symptoms develop, CK should be checked and management guided by the clinical picture and CK level.

Practical information for UK patients

Atorvastatin is a prescription-only medicine. In England, the standard NHS prescription charge is 9.90 pounds per item. Prescriptions are free in Scotland, Wales and Northern Ireland.

As a generic medicine, atorvastatin is one of the least expensive cardiovascular treatments available to the NHS.

A Prescription Prepayment Certificate (PPC) is available for patients in England who need regular prescriptions.

Store atorvastatin tablets below 25 degrees Celsius in the original packaging, protected from moisture. Keep out of sight and reach of children. Do not use after the expiry date. Return unused medicines to your pharmacy for safe disposal.

Sources and further reading

• Electronic Medicines Compendium (EMC), Atorvastatin SmPC: medicines.org.uk/emc
• British National Formulary (BNF), Atorvastatin monograph: bnf.nice.org.uk
• NICE Clinical Guideline CG181, Cardiovascular disease: risk assessment and reduction: nice.org.uk/guidance/cg181
• NHS, Atorvastatin: nhs.uk/medicines/atorvastatin
• MHRA Yellow Card Scheme: yellowcard.mhra.gov.uk