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Study Design1–3: A retrospective analysis of a managed care database of 11,552 high-risk patients (new CHD or diabetes diagnosis between January 1 and December 31,1999). Of those, 1,245 patients (11%) began lipid-lowering treatment (defined as 1 or more prescription fills within a 6-month period [mean days of supply = 140]).
Mean baseline LDL-C was 131mg/dL. Attainment of LDL-C <100 mg/dL was assessed at 6 and 12 months with an average follow up of 25 months.
Among patients continuing treatment at 6 months (n=600), 379 were statin-treated and 20 points or more from LDL-C <100 mg/dL.
Ninety-three patients were titrated; mean number of titrations at 12 months was 1.05. Three hundred eight patients continued treatment over 25 months, 112 patients were titrated; mean number of titrations = 1.14. Of those titrated, 43% (n=48) achieved LDL-C <100 mg/dL. In 1999, the ATP II–recommended LDL-C goal for patients with CHD was ≤100 mg/dL, whereas <130 mg/dL was considered desirable for patients with diabetes without CHD. The ADA-recommended LDL-C goal for patients with diabetes was ≤100 mg/dL.
Important Information About ZETIA
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) hypercholesterolemia when diet alone is not enough.
Contraindications: hypersensitivity to any component of this medication.
Contraindications when used with a statin: active liver disease; unexplained persistent elevations of serum transaminases. 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.
The effects of ZETIA, either alone or in addition to a statin, on the risk of cardiovascular morbidity and mortality have not been established.
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 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 and Patient Product Information.
References: 1. 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 20507201(2)-MSP. 2. The Expert Panel. Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA. 1993;269:3015–3023. 3. Haffner SM. Management of dyslipidemia in adults with diabetes. Diabetes Care.2004;27(suppl 1):S68–S71.
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