Comparison with Other Statins

Comparison with Other Statins

Pitavastatin & Pravastatin

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 & Atorvastatin

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 & Simvastatin

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.

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)

INDICATIONS & USAGE

Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.

Primary Hyperlipidemia and Mixed Dyslipidemia: Zypitamag is indicated as an adjunctive therapy to diet 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) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use: Doses of Zypitamag 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 Zypitamag. The effect of Zypitamag on cardiovascular morbidity and mortality has not been determined. Zypitamag has not been studied in Fredrickson Type I, III, and V dyslipidemias.

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 coadministration with cyclosporine.

WARNINGS & PRECAUTIONS

Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including pitavastatin.

  • These risks can occur at any dose level, but increase in a dose-dependent manner, with advanced age (≥ 65 years), renal impairment, and inadequately treated hypothyroidism; administer with caution in these patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin, or colchicine. Avoid concomitant administration with gemfibrozil.
  • Advise patients to promptly report unexplained and/or persistent muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever; discontinue Zypitamag.
  • If muscle signs and symptoms persist after discontinuation, this may be a sign of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy associated with statin use, requiring immediate medical attention. 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.
  • Zypitamag should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected.
  • Zypitamag 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).

Liver Enzyme Abnormalities:

  • Persistent elevation in hepatic transaminases can occur. Check liver enzymes before initiating therapy and if signs or symptoms of liver injury occur; advise patients to report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
  • Fatal and non-fatal hepatic failure can occur. Interrupt Zypitamag if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. If an alternate etiology is not found do not restart Zypitamag.
  • Use Zypitamag with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Do not use Zypitamag if patient has active liver disease, which may include unexplained persistent transaminase elevations.

Endocrine Function:

  • Increases in HbA1c and fasting serum glucose levels have been reported.

COMMON ADVERSE REACTIONS

Myalgia, back pain, diarrhea, constipation and pain in extremity (rate ≥ 2% in at least one marketed dose). 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