Adding ZETIA to Simvastatin

As an adjunct to diet when diet alone is not enough, based on a head-to-head study of one tablet containing ezetimibe and simvastatin vs simvastatin alone

Efficacy of ZETIA added to simvastatin

In a factorial design study, the ezetimibe plus simvastatin combination tablet had an overall favorable efficacy and safety profile compared with either simvastatin or ezetimibe alone.¹

• • 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.

Ezetimibe plus simvastatin vs simvastatin alone (N=1,528)¹

• • Mean baseline LDL-C was 176.2 mg/dL for all doses of ezetimibe plus simvastatin and 177.5 mg/dL for all doses of simvastatin.¹
• • Pooled results for ezetimibe plus simvastatin vs simvastatin alone demonstrated significantly greater mean percent reductions from baseline in LDL-C concentrations (–53% vs –39%; P<0.001).¹
• • The mean percent reduction from baseline in LDL-C achieved with ezetimibe plus simvastatin when compared with simvastatin alone was significant at each corresponding dose of simvastatin.¹
• • Administration of ezetimibe plus simvastatin was also associated with a greater mean percent reduction in LDL-C compared with the next highest incremental dose of simvastatin.¹

• SELECTED CAUTIONARY INFORMATION
• • When using ZETIA with a statin, also follow the label recommendations for that specific statin.
• • Because renal impairment is a risk factor for statin-associated myopathy, doses of simvastatin exceeding 20 mg should be used with caution and close monitoring when administered concomitantly with ZETIA in patients with moderate to severe renal impairment (eGFR <60 mL/min/1.73 m²).
• • ZETIA is not recommended in patients with moderate to severe hepatic impairment.
• • The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.

+ Enlarge chart + View study design

As an adjunct to diet when diet alone is not enough, based on a head-to-head study of one tablet containing ezetimibe and simvastatin vs simvastatin alone

What could help your patients get to
LDL-C goal?

Ezetimibe + simvastatin: More patients achieved LDL-C <70 mg/dL¹

• • Mean percent LDL-C reduction from a pooled analysis of all doses in all patients was 53% for ezetimibe + simvastatin vs 39% for simvastatin (P<0.001).¹
• • The clinical impact of comparative differences in lipid changes between products is not known.

Bays primary end point: Primary efficacy end point was mean percent change in LDL-C from baseline.¹

• SELECTED CAUTIONARY INFORMATION
• • Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
• • ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.

+ Enlarge chart + View study design

As an adjunct to diet when diet alone is not enough, based on a head-to-head study of one tablet containing ezetimibe and simvastatin vs simvastatin alone

What could help your patients get to
LDL-C goal?

Ezetimibe + simvastatin: More patients achieved LDL-C <100 mg/dL¹

• • Mean percent LDL-C reduction from a pooled analysis of all doses in all patients was 53% for ezetimibe + simvastatin vs 39% for simvastatin (P<0.001).¹
• • The clinical impact of comparative differences in lipid changes between products is not known.

Bays primary end point: Primary efficacy end point was mean percent change in LDL-C from baseline.¹

• SELECTED CAUTIONARY INFORMATION
• • In clinical trials, regardless of causality assessment, the most frequent side effects for ZETIA coadministered with a statin vs statin alone included nasopharyngitis (3.7% vs 3.3%), myalgia (3.2% vs 2.7%), upper respiratory tract infection (2.9% vs 2.8%), arthralgia (2.6% vs 2.4%), and diarrhea (2.5% vs 2.2%); for ZETIA administered alone vs placebo: upper respiratory tract infection (4.3% vs 2.5%), diarrhea (4.1% vs 3.7%), arthralgia (3.0% vs 2.2%), sinusitis (2.8% vs 2.2%), pain in extremity (2.7% vs 2.5%), and fatigue (2.4% vs 1.5%).

Additional Important Safety Information

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

Reference: 1. Bays HE, Ose L, Fraser N, et al. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004;26:1758–1773.