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  • Atorvastatin calcium: SAFETY(3)

There were no clinically important elevations in creatine phosphokinase associated with atorvastatin in the clinical trials . Myalgia was reported in 1% of patients treated with atorvastatin. This incidence was similar to that reported for patients on placebo or those treated with the other HMG-CoA reductase inhibitors. No cases of myoglobinuria or acute renal failure were reported. The risk of myopathy during treatment with HMG-CoA reductase inhibitors increases with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin (nicotinic acid) or azole antifungals.

No evidence of a conclusive characterization of myopathy in the atorvastatin clinical safety database was reported; however, patients receiving concurrent medications known to increase the risk of myopathy were excluded from the clinical studies . The benefits and risks of such combined therapy should, therefore, be carefully considered. Consistent with established clinical practice for other HMG-CoA reductase inhibitors, atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolosis.

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