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Antihyperlipidaemic Agents

CHD: Reduce risk of death, coronary death & non-fatal MI; Reduce risk for undergoing myocardial revascularization procedures (CABG & PTCA); slow progression of coronary atherosclerosis, including reducing development of new lesions & new total occlusions. Hyperlipidemia: As an adjunct to diet to reduce elevated total-C, LDL-C, Apo B & TG, LDL-C/HDL-C & total-C/HDL-C ratios & to increase HDL-C in primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia when response to diet & other nonpharmacological measures is inadequate.

CHD Initially, 20 mg nocte. Hyperlipidemia Initially, 20 mg nocte. Patients who require only a moderate reduction of LDL-C may start at 10mg nocte. Homozygous familial hypercholesterolemia 40 mg nocte or 80 mg/day in 3 divided doses of 20 mg, 20 mg, & 40 mg nocte. To be used as an adjunct to other lipid-lowering treatments (eg LDL apheresis) in these patients or if such treatments are unavailable. Concomitant therapy Effective as monotherapy or combination therapy w/ bile acid sequestrants. In patients concomitantly on cyclosporine, gemfibrozil, other fibrates or lipid-lowering doses (≥ (greater than or equal to) 1 g/day) of niacin, max: 10 mg/day. In patients concomitantly on amiodarone or verapamil, max: 20 mg/day. Moderate renal insufficiency Dose adjustment unnecessary. Severe renal insufficiency (CrCl < 30 mL/min) Caution w/ doses > 10 mg/day.

Should be taken with food.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.

Increased risk of myopathy & rhabdomyolysis w/ concomitant use of certain drugs. Risk of myopathy & rhabdomyolysis is dose related. Substantial alcohol consumption &/or past history of liver disease. Clinical studies have reported persistent increases (to > 3x upper limit of normal) in serum transaminases in a few adults. Perform baseline liver function tests & thereafter when clinically indicated. Patients titrated to 80 mg should receive an additional test before titration, 3 mth post-titration & periodically thereafter for 1st yr of treatment.

Abdominal pain, constipation & flatulence. Other AR reported in 0.5-0.9% of patients: asthenia, headache, nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting & anemia. Rarely myopathy, rhabdomyolysis & hepatitis, jaundice, apparent hypersensitivity syndrome including angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, increased ESR, arthritis, arthralgia, urticaria, photosensitivity, fever, flushing, dyspnea, & malaise.

Increased risk of myopathy & rhabdomyolysis w/ concomitant use of potent CYP3A4 inhibitors eg cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, esp w/ higher doses of simvastatin. Lipid-lowering drugs that can cause myopathy when given alone: gemfibrozil, other fibrates, or lipid-lowering doses (≥ (greater than or equal to) 1 g/day) of niacin, esp w/ higher doses of simvastatin. Other drugs: amiodarone or verapamil, w/ higher doses of simvastatin. Grapefruit juice, coumarin anticoagulants.

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