As an adjunct to diet when diet alone is not enough, in high-risk patients with hypercholesterolemia

Additional LDL-C efficacy with ZETIA +
atorvastatin 40 mg vs doubling the dose of atorvastatin to 80 mg1

  • • The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
  • • ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, Apo B, and non–HDL-C in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia when diet alone is not enough.
  • • Contraindications: hypersensitivity to any component of this medication.
  • • Statin contraindications apply when used with a statin: active liver disease; unexplained persistent elevations in hepatic transaminase levels. Statins are contraindicated in pregnant and nursing women. Refer to the statin label for details.
  • SELECTED CAUTIONARY INFORMATION
  • • When using ZETIA with a statin, also follow the label recommendations for that specific statin.

In a study of patients with hypercholesterolemia at high risk of CHD who had not reached optional NCEP ATP III LDL-C goal (<70 mg/dL) on atorvastatin alone, mean additional percent reduction in LDL-C after 6 weeks of treatment was demonstrated.1

EZ-PATH primary end point: Percent change from baseline in LDL-C after 6 weeks of adding ezetimibe to atorvastatin 40 mg vs doubling the dose to 80 mg.1

Mean Treated Baselines1

Treatment LDL-C
ZETIA + atorvastatin 40 mg 89 mg/dL (n=277)
atorvastatin 80 mg 90 mg/dL (n=279)

As an adjunct to diet when diet alone is not enough, as a result of superior LDL-C reduction in high-risk patients with hypercholesterolemia

Adding ZETIA: Superior achievement of LDL-C <70 mg/dL vs doubling the dose of atorvastatin 40 mg to 80 mg1

  • SELECTED CAUTIONARY INFORMATION
  • • When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (>3 × ULN) were slightly higher (1.3%) than those of statins alone (0.4%). Liver function tests should be performed when ZETIA is added to statin therapy and according to statin recommendations. Should an increase in ALT or AST >3 × ULN persist, consider withdrawal of ZETIA and/or the statin.
  • • Patients should be advised to promptly report muscle pain, tenderness, or weakness. Risk for skeletal muscle toxicity increases with higher statin doses, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Discontinue drug if myopathy is diagnosed or suspected.

aBased on the predictive odds of attaining
LDL-C <70 mg/dL for ZETIA added to atorvastatin
40 mg vs atorvastatin 80 mg (odds ratio = 8.4).

Additional Important Safety Information

Before prescribing ZETIA, please read the Prescribing Information. The Patient Information also is available.

Reference: 1. Leiter LA, Bays H, Conard S, et al. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008;102:1495–1501.


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