Comparison with Other Statins

Comparison with Other Statins

Pitavastatin & Pravastatin

Pitavastatin & Pravastatin

Pitavastatin & Pravastatin Graph

Study 306: 12 week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority (NI) study. NI was met if the lower bound of the 95% Cl for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

* Pitavastatin was not studied against Pravastatin 80 mg.

Pitavastatin & Pravastatin Table

Pitavastatin & Atorvastatin

Pitavastatin & Atorvastatin

Pitavastatin & Atorvastatin Graph

Study 301: 12 week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority (NI) study. NI was met if the lower bound of the 95% Cl for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

* Pitavastatin was not studied against Atorvastatin 40 mg and 80 mg doses.

Pitavastatin & Atorvastatin Table

Pitavastatin & Simvastatin

Pitavastatin & Simvastatin

Pitavastatin & Simvastatin Graph

Study 302: 12 week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority (NI) study. NI was met if the lower bound of the 95% Cl for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

* Pitavastatin was not studied against Simvastatin 80 mg.

Pitavastatin & Simvastatin Table

References:

1) Zypitamag [prescribing information]. Ahmedabad, India: Cadila Healthcare Ltd; March 2018.

2) Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013;20(1):40-53.

3) Budinski DF, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia. Clin Lipidol. 2009;4(3):291-302.

4) Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia [published correction appears in Curr Med Res Opin. 2010;26(5):1046]. Curr Med Res Opin. 2009;25(11):2755-2764.

IMPORTANT SAFETY INFORMATION FOR ZYPITAMAG™ (pitavastatin) tablets

INDICATIONS & USAGE

ZYPITAMAG is indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). Limitations of Use: The effect of ZYPITAMAG on cardiovascular morbidity and mortality has not been determined.

CONTRAINDICATIONS: ZYPITAMAG is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers, or in co-administration with cyclosporine.

WARNINGS & PRECAUTIONS

  • Myopathy and Rhabdomyolysis: Risk factors include age 65 and greater, renal impairment, inadequately treated hypothyroidism, concomitant use of certain drugs, and higher doses of ZYPITAMAG. ZYPITAMAG is contraindicated in patients taking cyclosporine and not recommended in patients taking gemfibrozil. The following drugs when used concomitantly with ZYPITAMAG may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1 g/day), fibrates, and colchicine. Discontinue ZYPITAMAG if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue ZYPITAMAG in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis; e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the ZYPITAMAG dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever.
  • Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of 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; and improvement with immunosuppressive agents.
  • Hepatic Dysfunction: Increases in serum transaminases can occur. Rare postmarketing reports of fatal and non-fatal hepatic failure have occurred. Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ZYPITAMAG.
  • Increases in HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with statins, including ZYPITAMAG. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

ADVERSE REACTIONS: The most frequent adverse reactions (rate ≥ 2%) are myalgia, back pain, diarrhea, constipation and pain in extremity. This is not a complete list of all reported adverse events.

For additional information, refer to full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch
or call 1-800-FDA-1088

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