Simvastatin
HMG-CoA reductase inhibitor · “The rhabdomyolysis interaction”
The Clinical Case
Male, 71 yo. Stable angina on amlodipine 10 mg and diltiazem. Longstanding dyslipidaemia on a statin. GP increases the dose to the historical maximum seeking further LDL lowering. Three months "later": severe myalgia, CK 8,200 U/L, dark urine. What statin was he taking, and why did this happen?
The Answer
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Clinical Pearl
FDA restriction: 80 mg dose restricted (2011) due to excess myopathy/rhabdomyolysis — 40 mg is the current approved maximum
All Hints
FDA restriction: 80 mg dose restricted (2011) due to excess myopathy/rhabdomyolysis — 40 mg is the current approved maximum
CYP3A4: Strong CYP3A4 substrate — contraindicated with amlodipine >10 mg, diltiazem, verapamil, amiodarone
Prodrug: Lactone prodrug activated in the liver; LDL reduction ~30–45% at max dose
Grapefruit: Grapefruit inhibits intestinal CYP3A4 → plasma levels up to 3-fold higher — explicit patient counselling required
Practical: Largely replaced by rosuvastatin/atorvastatin in polypharmacy patients; still used in uncomplicated dyslipidaemia
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