ATLANTA, March 7, 2013 /PRNewswire/ -- Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company (NYSE:LLY) announced results of a study evaluating the efficacy of LIVALO ® (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C) in HIV-infected adults with high cholesterol, or dyslipidemia. The study was designed as a superiority trial for the primary endpoint, percent reduction in LDL-C, and evaluated HIV-infected adults with dyslipidemia; with and without viral Hepatitis B or C. The study met its primary endpoint. 1
- Doses of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of LIVALO.
- The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.
- LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.
- LIVALO should be prescribed with caution in patients with predisposing factors for myopathy
- The risk of skeletal muscle effects (e.g., myopathy, and rhabdomyolysis) increases in a dose-dependent manner with advanced age ( >65 years), renal impairment, inadequately treated hypothyroidism, and in combination use with fibrates or lipid-modifying doses of niacin ( >1 g/day)
- LIVALO should be administered with caution in patients with impaired renal function, in elderly patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin
- Concomitant administration of LIVALO with gemfibrozil should be avoided
- LIVALO therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. LIVALO therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled seizures)
- Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and to discontinue LIVALO if these signs or symptoms appear
- There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. IMNM has not been reported with LIVALO therapy
- Advise patients to promptly report if muscle signs and symptoms persist after discontinuing LIVALO as this may be a sign of IMNM requiring immediate medical attention
- It is recommended that liver enzyme tests be performed before the initiation of LIVALO and if signs or symptoms of liver injury occur
- There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pitavastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with LIVALO, promptly interrupt therapy. If an alternate etiology is not found do not restart LIVALO
- Advise patients to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice
- LIVALO should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
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