Triglyceride (TG) Levels

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Important Information About ZETIA
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ZETIA coadministered with pooled doses of each statin lowered TG levels further than with pooled doses of each statin alonea,b

ZETIA + simvastatin lowered TG levels by –29% vs –20% with pooled simvastatin alone (P≤0.01).

ZETIA + pravastatin lowered TG levels by –21% vs –14% with pooled pravastatin alone (P≤0.01).

ZETIA + lovastatin lowered TG levels by –25% vs –12% with pooled lovastatin alone (P≤0.01).

a
Median baseline TG levels for atorvastatin, simvastatin, pravastatin, and lovastatin alone were 155, 157, 180, and 167 mg/dL, respectively; and for ZETIA + atorvastatin, simvastatin, pravastatin, and lovastatin were 165, 168, 173, and 164 mg/dL, respectively.
b
Four 12-week, double-blind studies evaluating ZETIA coadministered with atorvastatin (N=628, 10–80 mg), simvastatin (N=668,10–80 mg), pravastatin (N=538, 10–40 mg), or lovastatin (N=548, 10–40 mg) compared with those statins alone in patients with hypercholesterolemia. Results were pooled across each statin dose range; results shown are for all atorvastatin doses alone (n=248) vs ZETIA + atorvastatin (n=255).

Important Information About ZETIA

The independent effect of lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

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, and Apo B 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.

When using ZETIA with a statin, also follow the label recommendations for that specific statin.

Selected Cautionary Information: When ZETIA was coadministered with a statin, consecutive elevations in serum transaminases (≥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.

Patients should be advised to promptly report muscle pain, tenderness, or weakness. Discontinue drug if myopathy is diagnosed or suspected.

ZETIA is not recommended in patients with moderate or severe hepatic insufficiency.

The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is studied.

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.

In clinical trials, the most frequent side effects in individuals, regardless of age, for ZETIA alone vs placebo included back pain (4.1% vs 3.9%), arthralgia (3.8% vs 3.4%), and fatigue (2.2% vs 1.8%); for ZETIA + statin vs statin or placebo alone: back pain (4.3% vs 3.7% vs 3.5%), abdominal pain (3.5% vs 3.1% vs 2.3%), and fatigue (2.8% vs 1.4% vs 1.9%).

 

Before prescribing ZETIA, please read the Prescribing Information.

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