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.
SELECTED CAUTIONARY INFORMATION
When using ZETIA with a statin, also follow the label recommendations for that specific statin.
When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (≥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. Should an increase in ALT or AST ≥3 × 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.
Study Design1–4: This retrospective analysis of a managed care database evaluated high-risk patients (new diagnosis of
CHD or diabetes between 1/1/99 and 12/31/00). Mean baseline LDL-C=131 mg/dL. Attainment of LDL-C <100 mg/dL was assessed at 6 and 12 months, and at end of follow-up (mean of 26 months). Treatment was defined as ≥1 pharmacy claim for a lipid medication during the time period. Of the patients with newly diagnosed CHD or diabetes, 1,245 were tested and treated with lipid therapy during months 1–6. Mean days of therapy=114. Of these patients, 39% (n=485) reached LDL-C <100 mg/dL in months 1–6 and 61% (n=760) did not. Among those who did not get to goal within 6 months of diagnosis, 496 continued to be treated for the follow-up period of 25 months. During follow-up, 167 patients were titrated; mean number of titrations=1.19. Of those titrated, 52% of patients did not achieve goal. Overall, in 11,552 patients with newly diagnosed CHD or diabetes, cumulative attainment of LDL-C <100 mg/dL among those treated was 50% in months 7–12 and 58% in month 7 to end of
follow-up. 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.
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(5)-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.
4. Nag SS, Daniel GW, Bullano MF, et al. LDL-C goal attainment among patients newly diagnosed with coronary heart disease or diabetes in commercial HMO. J Manag Care Pharm. 2007;13:652–663.
5. NCEP Expert Panel. Final Report of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, MD: National Heart, Lung, and Blood Institute. National Institutes of Health; 2002. NIH publication 02–5215.
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