Atorvastatin

Class
Hypolipidemic agents
Subclass
HMG-CoA reductase inhibitors
Substance name
Atorvastatin calcium
Brand names
Lipitor®, Atorvaliq®
Common formulations
Film-coated tablet
Contained in
Amlodipine / atorvastatin (Caduet®)
Dosage and administration
Adults patients
Treatment
Dyslipidemia
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Familial dysbetalipoproteinemia
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Heterozygous familial hypercholesterolemia
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Hypertriglyceridemia
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Adjunctive treatment
Adjunctive treatment for homozygous familial hypercholesterolemia
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Prevention
Cardiovascular events in patients with coronary artery disease
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Cardiovascular events in patients with diabetes mellitus type 2
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Cardiovascular events in patients with multiple risk factors for coronary artery disease
•
Start at: 10-20 mg PO daily
•
Maintenance: 10-80 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Cardiac allograft vasculopathy • Off-label
•
Start at: 10 mg PO daily from 1-2 weeks after transplantation
•
Maintenance: 10-20 mg PO daily
Consider starting at 40 mg daily in patients requiring > 45% reduction of LDL-C
Indications for use
Labeled indications
Adults
•
Treatment of dyslipidemia
•
Treatment of familial dysbetalipoproteinemia
•
Treatment of heterozygous familial hypercholesterolemia
•
Treatment of hypertriglyceridemia
•
Adjunctive treatment for homozygous familial hypercholesterolemia
•
Prevention of cardiovascular events in patients with coronary artery disease
•
Prevention of cardiovascular events in patients with diabetes mellitus type 2
•
Prevention of cardiovascular events in patients with multiple risk factors for coronary artery disease
Children
•
Treatment of heterozygous familial hypercholesterolemia
Off-label indications
Adults
•
Prevention of cardiac allograft vasculopathy
Safety risks
Contraindications
Hypersensitivity to atorvastatin or its components
ALF or decompensated cirrhosis
Concomitant consumption of large amounts of grapefruit juice
Warnings and precautions
Exacerbation of hepatic dysfunction
•
Use caution in patients with alcohol use disorder or a history of hepatic disease. Consider testing liver enzymes before treatment and monitoring thereafter. Discontinue in case of symptoms of serious hepatic injury, jaundice, or hyperbilirubinemia.
Hemorrhagic stroke
•
Use caution when using high-dose (80 mg) atorvastatin in patients with a recent history of hemorrhagic stroke.
Increased blood glucose, increased HbA1c, immune-mediated necrotizing myopathy
•
Maintain a high level of suspicion, as an increased risk has been reported in patients receiving statins.
Statin-induced myopathy, rhabdomyolysis
•
Use caution in patients with uncontrolled hypothyroidism, renal impairment, taking other drugs increasing myopathy risk, or aged ≥ 65 years. Discontinue in case of a marked increase in CK levels or suspected or diagnosed myopathy. Discontinue temporarily in case of an acute or serious condition predisposing to renal failure secondary to rhabdomyolysis, such as sepsis, severe hypovolemia, major trauma or surgery, or severe electrolyte disorders.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor for myopathy.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required. Monitor for myopathy.
Intermittent hemodialysis
•
Use acceptable. No dose adjustment required. Monitor for myopathy.
Peritoneal dialysis
•
Use acceptable. No dose adjustment required. Monitor for myopathy.
Hepatic impairment
Any severity
•
Do not use.
Substantial chronic alcohol consumption
•
Use with caution. Monitor serum aminotransferases. Monitor for toxicity.
Unexplained abnormality in LFTs
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Advise women of reproductive age to use effective contraception during treatment with atorvastatin. Discontinue treatment if patient becomes pregnant while taking atorvastatin.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
Arthralgia, diarrhea
Common 1-10%
•
Acute liver failure, diabetes mellitus, immune-mediated necrotizing myopathy, intracerebral hemorrhage, nasopharyngitis, peripheral neuropathy, confusion, dizziness, dyspepsia, flatulence, insomnia, malaise, memory impairment, muscle spasms, musculoskeletal pain, myalgia, nausea, nightmares, pain in extremity, urinary tract infections, urticaria
Uncommon < 1%
•
↑ liver enzymes
Unknown frequency
•
Angioedema, bullous pemphigoid, coenzyme Q10 deficiency, ↓ WBC count, ↓ platelet count, dermatomyositis, erythema multiforme, hemolytic anemia, interstitial lung disease, ↑ blood eosinophil count, ↑ blood glucose, ↑ serum TBIL, ↑ urine myoglobin, jaundice, myasthenia gravis, myopathy, pancreatitis, photosensitivity of skin, purpura, renal failure, abdominal pain, belching, blurred vision, chills, depression, dyspnea, fatigue, fever, muscle weakness, nosebleed, skin flushing, tinnitus, rhabdomyolysis, systemic lupus erythematosus, Stevens-Johnson syndrome, tendon rupture, toxic epidermal necrolysis, vasculitis
Interactions
Drug(s)
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