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.
a
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 patients who did not attain
LDL-C <100 mg/dL and who continued treatment beyond 6 months (n=600), 379 were statin
treated with LDL-C ≥120 mg/dL. Of these patients, 93 were titrated; mean number of titrations
at 12 months=1.05. At 12 months, 15% (n=14) achieved LDL-C <100 mg/dL. Over 25 months, 308 patients continued treatment; of these, 112 patients were titrated; mean number of titrations=1.14.
Of those titrated, 43% (n=48) achieved LDL-C <100 mg/dL.
LDL-C <100 mg/dL and who continued treatment beyond 6 months (n=600), 379 were statin
treated with LDL-C ≥120 mg/dL. Of these patients, 93 were titrated; mean number of titrations
at 12 months=1.05. At 12 months, 15% (n=14) achieved LDL-C <100 mg/dL. Over 25 months, 308 patients continued treatment; of these, 112 patients were titrated; mean number of titrations=1.14.
Of those titrated, 43% (n=48) achieved LDL-C <100 mg/dL.
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.
<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
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. 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(4)-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(23):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(8):652–663.
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