Triglyceride (TG) Levels

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Important Information About ZETIA

As an adjunct to diet when diet alone is not enough In patients with mixed hyperlipidemia ZETIA Coadministered With Fenofibrate Significantly Lowered LDL-C Compared With Fenofibrate Administered Alone(a)

Chart: Mean Percent Change in LDL-C From Untreated Baseline, Week 12
Click here for Study Design
bullet gif The effects of ZETIA, either alone or in addition to a statin or fenofibrate, on the risk of cardiovascular morbidity and mortality have not been established.
bullet gif ZETIA administered in combination with fenofibrate is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, Apo B, and non–HDL-C in adult patients with mixed hyperlipidemia when diet alone is not enough. 
SELECTED CAUTIONARY INFORMATION 
bullet gif ZETIA is not recommended in patients with moderate to severe hepatic impairment.
bullet gif The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.
bullet gif Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
bullet gif ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.
bullet gif 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%).
bullet gif Incidence rates (95% CI) for clinically important elevations (≥3 × ULN, consecutive) in hepatic transaminase levels were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for fenofibrate monotherapy (n=188) and ZETIA coadministered with fenofibrate (n=183), respectively, adjusted for treatment exposure.
bullet gif When ZETIA was coadministered with fenofibrate, incidence rates for cholecystectomy were 0.6% and 1.7% for fenofibrate monotherapy and ZETIA coadministered with fenofibrate, respectively.

Before prescribing ZETIA, please read the Prescribing Information.

a

Study Design1: A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-arm study (N=625) of patients with mixed hyperlipidemia. Patients were randomized to receive placebo, ZETIA, fenofibrate 160 mg, or ZETIA + fenofibrate 160 mg. The primary end point was percent change in LDL-C after treatment with ZETIA + fenofibrate 160 mg compared with fenofibrate alone. Mean baseline LDL-C levels for the group receiving fenofibrate 160 mg and the group receiving ZETIA + fenofibrate 160 mg were 166 mg/dL and 162 mg/dL, respectively.

Reference:
1. Farnier M, Freeman MW, Macdonell G, et al. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005;26:897–905.

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21050228(1)-06/10-ZET