a
Study Design1: Four multicenter, randomized, double-blind, placebo-controlled, balanced, parallel-group trials were pooled for analysis to compare the efficacy and safety of statin monotherapy vs ZETIA + statin in older and younger adults (N=1,861) with primary hypercholesterolemia. In each of the 4 primary studies, patients were randomized to receive placebo, statin monotherapy, or ZETIA + statin for 12 weeks. The primary end point was the percent reduction in LDL-C from baseline; mean baseline for all age groups was 178 mg/dL.
An age subset analysis was carried out to determine whether the incremental reduction in LDL-C with coadministration of ZETIA and statin vs statin monotherapy was similar across age groups.
b
Mean reduction in LDL-C from baseline for patients aged <65 years was –32% and –45% for pooled statin monotherapy and ZETIA and pooled statin, respectively. Mean reduction in LDL-C from baseline for patients aged ≥65 years was –35% and –50% for pooled statin monotherapy and ZETIA and pooled statin, respectively.2
Important Information About ZETIA
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 hepatic transaminase levels (>3 x 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 x 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.
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.
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, 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%), and pain in extremity (2.7% vs 2.5%).
Before prescribing ZETIA, please read the Prescribing Information.
References: 1. Lipka L, Sager P, Strony J, Yang B, Suresh R, Veltri E. Efficacy and safety of coadministration of ezetimibe and statins in elderly patients with primary hypercholesterolemia. Drugs Aging. 2004;21(15):1025–1032, adapted with permission. 2. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package 20603078(2)-ZET.
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