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Zetia Reprint Holder Atorvastatin Corbett Work Sample Crystal Kaczkowski Watermarked
 

Zetia Reprint Holder Atorvastatin Corbett Work Sample Crystal Kaczkowski Watermarked

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    Zetia Reprint Holder Atorvastatin Corbett Work Sample Crystal Kaczkowski Watermarked Zetia Reprint Holder Atorvastatin Corbett Work Sample Crystal Kaczkowski Watermarked Document Transcript

    • ZETIA +STATIN DUAL INHIBITION ZETIA+10-mg Atorvastatin: Dramatically More Effective at Lowering LDL-C Than 20-mg or 40-mg Atorvastatin Alone Crystal Kaczkowski writing sample “Coadministration of ezetimibe plus atorvastatin was significantly (P<0.01) more effective at reducing LDL-C concentrations than atorvastatin or ezetimibe alone for both the pooled treatment groups and each atorvastatin dose.” —Circulation. 2003;107:2409–2415. Reprinted with permission. 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.
    • ZETIA +STATIN DUAL INHIBITION Atorvastatin Alone* atorvastatin alone 10 mg 20 mg 40 mg 80 mg (n=60) (n=60) (n=66) (n=62) MEAN PERCENT CHANGE IN LDL-C FROM UNTREATED BASELINE –37% –42% –45% –54% *Atorvastatin Coadministration Study Design: A 12-week, double-blind study (N=628) comparing ZETIA initiated concurrently with atorvastatin vs atorvastatin alone in patients with primary hypercholesterolemia. Mean baseline LDL-C for ZETIA + atorvastatin was 182 mg/dL, and for atorvastatin alone was 181 mg/dL. Differences in LDL-C reduction between doses werewriting and –9% as shown above. Crystal Kaczkowski –5%, –3%, sample In clinical trials, there was no excess of myopathy or rhabdomyolysis associated with ZETIA compared with statin or placebo alone. However, myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs. 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. Caution should be exercised when initiating ZETIA in patients treated with cyclosporine, particularly in patients with severe renal insufficiency, due to increased blood levels of ZETIA. In such patients, the potential effects of these increased levels should be carefully weighed against the benefits of further alterations in lipid levels provided by ZETIA. Coadministration of cholestyramine or gemfibrozil affected the bioavailability of ZETIA.
    • Adding ZETIA: Dramatically More LDL-C Reduction Than Double the Atorvastatin 10-mg Dose atorvastatin alone ZETIA + atorvastatin 10 mg 10 mg 20 mg 40 mg 80 mg (n=65) (n=60) (n=60) (n=66) (n=62) MEAN PERCENT CHANGE IN LDL-C FROM UNTREATED BASELINE –53% –37% –42% –45% –54% Crystal Kaczkowski writing sample Adding ZETIA to 10-mg atorvastatin Significantly more LDL-C reduction than 20-mg or 40-mg atorvastatin...double or quadruple the 10-mg atorvastatin dose. ZETIA provided added LDL-C reductions to every dose of atorvastatin. 61% reduction in LDL-C when ZETIA was added to 80-mg atorvastatin. The safety and effectiveness of ZETIA with fibrates have not been established; therefore, coadministration with fibrates is not recommended until use in patients is studied. In clinical trials, most frequent side effects, regardless of cause and at incidence greater than placebo, for ZETIA alone vs placebo included: back pain (4.1% vs 3.9%) and arthralgia (3.8% vs 3.4%); for ZETIA + statin vs statin or placebo alone: back pain (4.3% vs 3.7% vs 3.5%) and abdominal pain (3.5% vs 3.1% vs 2.3%).
    • ZETIA +STATIN DUAL INHIBITION Crystal Kaczkowski writing sample
    • ZETIA +STATIN DUAL INHIBITION +a Statin: ZETIA Dramatic LDL-C Reduction Through Dual Inhibition In a clinical trial, when ZETIA was initiated concurrently with atorvastatin 10 mg1: ZETIA + 10-mg atorvastatin provided dramatically more LDL-C reduction than 20-mg or 40-mg atorvastatin alone. Dual inhibition: ZETIA inhibits cholesterol absorption in the intestine. Statins inhibit cholesterol production in the liver. 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 ZETIA was coadministered with a statin, consecutive elevations in serum transaminases (≥3 × ULN) were slightly higher (1.3%) than those sample (0.4%). Crystal Kaczkowski writing of statins alone Liver function tests should be performed when ZETIA is added to statin therapy and according to statin recommendations. Because of the unknown effects of ZETIA in patients with moderate or severe hepatic insufficiency, ZETIA is not recommended in these patients. Before prescribing ZETIA, please read the enclosed Prescribing Information. Reference: 1. Ballantyne CM, Houri J, Notarbartolo A, et al, for the Ezetimibe Study Group. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Circulation. 2003;107:2409–2415. zetia.com EZ0049 ©Merck/Schering-Plough Pharmaceuticals, 2004. All rights reserved. 20402799(1)-03/04-ZET Printed in USA Minimum 10% Recycled Paper