Statin for Hipirlepid

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    Prescribing Focus:

    Statins for the Management of Hyperlipidemia

    Introduction

    It is estimated that 102.2 million adults in the US have total blood cholesterol values of 200 mg/dL,

    with about 35.7 million having levels 240 mg/dL, significantly increasing the risk for cardiovascular

    events (CV) in these patients.1Statinsor HMG-CoA reductase inhibitorshave demonstrated the ability

    to reduce the risk of adverse CV events in diverse patient populations. This Prescribing Focusoffers

    recommendations for the management of hyperlipidemia with statin therapy to decrease morbidity and

    mortality in your patients with CV risk.

    Lipoprotein Profile Testing in Adults2

    The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) recommends a

    fasting lipoprotein profile test, including LDL-C screening every 5 years in all low-risk adults age 20 and

    over. For those with diabetes or coronary heart disease, annual testing is recommended with an LDL-Cgoal of

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    Selecting a Statin for Your Patient4

    There are different factors to consider when selecting the appropriate statin for your patient, including:

    The extent of each statins ability to lower LDL-C levels and raise HDL-C levels (Table 1)

    Drug interactions between statins and your patients concurrent drug therapy (Table 2). With the

    exception of pravastatin, all other statins undergo microsomal metabolism by the cytochrome

    P450 isoenzyme systems. About half of all medications currently available in clinical practice are

    metabolized by CYP3A4.4

    Your patients prescription drug coverage. Some statins may be subject to prior authorizations

    or step therapy edits.

    Table 1. Relative Lipid-Lowering Efficacy of Statins Mean Changes from Baseline (%)4

    The results in the table are derived from various clinical trials. Therefore, any direct comparisons of

    the lipid-lowering effects of each medication should take into account the differences in trial design,

    endpoints and patient demographics.

    Drug Name and Dosage LDL-C HDL-C TG

    Altoprev (lovastatin, extended-release)

    20 mg QD -30 +12 -13

    40 mg (QD or divided BID) -35 +13 -10

    60 mg (QD or divided BID) -40 +12 -25

    Crestor (rosuvastatin)

    5 mg QD -28 to 45 +3 to 13 -21 to 35

    10 mg QD -45 to 52 +8 to 14 -10 to 37

    20 mg QD -31 to 55 +8 to 22 -23 to 37

    40 mg QD -43 to 63 +10 to 17 -28 to 43

    Lescol (fluvastatin)

    20 mg QPM -22 to 25 +2 to 6 -12 to 17

    40 mg QPM -24 to 31 +4 to 8 -14 to 20

    40 mg BID (80 mg) -34 to 36 +4 to 9 -18 to 23

    Lescol XL (fluvastatin, extended-release)

    80 mg QPM -33 to 38 +7 to 11 -19 to 25

    Lipitor (atorvastatin)

    10 mg QD -27 to 39 +6 to 14 -17 to 41

    20 mg QD -30 to 43 +9 to 11 -26 to 39

    40 mg QD -50 +6 -29

    80 mg QD -41 to 60 +5 to 7.5 -37 to 53

    *Generic available

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    Drug Name and Dosage LDL-C HDL-C TG

    Livalo (pitavastatin)

    1 mg QD -32 +8 -15

    2 mg QD -36 +7 -19

    4 mg QD -43 +5 -18

    Mevacor (lovastatin)*

    10 mg QD -21 +5 -10

    20 mg (QD or divided BID) -24 to 28 +6 to 8 -7 to 10

    40 mg (QD or divided BID) -30 to 34 +2 to 9 -6 to 21

    80 mg (QD or divided BID) - 40 to 42 +8 to 10 -19 to 27

    Niaspan (niacin, extended release)

    1000 mg QPM -5 +18 -21

    1500 mg QPM -12 +20 -13

    2000 mg QPM -14 +22 -28

    Pravachol (pravastatin)*

    10 mg QD -22 +7 -15

    20 mg QD -26 to 32 +1 to 2 -10 to 11

    40 mg QD -21 to 41 +5 to 14 -12 to 24

    80 mg QD -37 +3 -19

    Zocor (simvastatin)*

    5 mg QD -26 +10 -12

    10 mg QD -30 +12 -15

    20 mg QD -38 +8 -19

    40 mg QD -28 to 50 +7 to 13 -8 to 41

    80 mg QD -36 to 51 +7 to 16 -24 to 38

    *Generic available

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    Drug Name and Dosage LDL-C HDL-C TG

    Combination Products

    Advicor (niacin ER/lovastatin)

    2000 mg/40 mg QHS -47 (women)-34 (men)

    + 33 (women)+24 (men)

    -48 (women)-35 (men)

    Caduet (amlodipine/atorvastatin )

    2.5 mg/10 mg N/A N/A N/A

    2.5 mg/20mg N/A N/A N/A

    2.5 mg/40mg N/A N/A N/A

    5 mg/10 mg -39 N/A N/A

    5 mg/20mg -42 N/A N/A

    5 mg/40mg -45 N/A N/A

    5 mg/80mg -48 N/A N/A

    10mg/10 mg -37 N/A N/A

    10mg/20mg -39 N/A N/A

    10mg/40mg -43 N/A N/A

    10mg/80mg -49 N/A N/A

    Simcor (niacin ER/simvastatin)

    1000mg/20mg QPM -12 21 -27

    2000mg/20mg QPM -14 29 -38

    1000mg/40mg QPM -7 15 -23

    2000mg/40mg QPM -5 24 -32

    Vytorin (ezetimibe/simvastatin)

    10 mg/10 mg QD -45 +8 -23

    10 mg/20 mg QD -52 +10 -24

    10 mg/40 mg QD -55 +6 -23

    10 mg/80 mg QD -60 +6 -31

    N/A = Not available *Generic available

    Note: The information above is provided for your reference only. Not all products listed may be included

    in the health plan's formulary. Please call your patient's health plan to inquire about the formulary status

    of the desired statin medication or for more benefit information.

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    Table 2. Myopathy and Rhabdomyolysis Drug-Drug Interactions4,5

    The risk of myopathy with statins is increased when used in combination with drugs listed in Table 2

    below. These interactions range from moderate to severe in nature. Please refer to the package inserts

    for the full range of drug interactions associated with each statin.

    Interacting

    Drug

    Advicor(niacinER/lovastatin)

    Cre

    stor(rosuvastatin)

    Les

    col(fluvastatin)

    Les

    colXL(fluvastatin,extended-release)

    Lipitor(atorvastatin)

    Cad

    uet(amlodipine/atorvastatin)

    Mevacor(lovastatin)

    Altoprev(lovastatin,extended-release

    )

    Pravachol(pravastatin)

    Vyt

    orin(ezetimibe/simvastatin)

    Zoc

    or(simvastatin)

    Sim

    cor(niacinER/simvastatin)

    Livalo(pitavastatin)

    Amiodarone x xc xe xe

    Itraconazole x x x x xf xf

    Ketoconazole x x x x xf xf

    Posaconazole x x x x xf xf

    Cyclosporine xa x x xd x xf xf x

    Macrolides

    (clarithromycin

    erythromycin)

    x x x xf xf xh

    Fenofibrate x xb x x xd x x x x

    aCrestor dose should not exceed 5 mg/day

    bCrestor dose should not exceed 10 mg/daycLovastatin dose should not exceed 40 mg/daydLovastatin dose should not exceed 20 mg/dayeSimvastatin dose should not exceed 10 mg/day

    fUse with simvastatin is contraindicated

    gSimvastatin dose should not exceed 20 mg/dayhPitavastatin dose should not exceed 1 mg/dayiPitavastatin dose should not exceed 2 mg/day

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    Interacting

    Drug

    Advicor(niacinER/lovas

    tatin)

    Crestor(rosuvastatin)

    Lescol(fluvastatin)

    LescolXL(fluvastatin,ex

    tended-release)

    Lipitor(atorvastatin)

    Caduet(amlodipine/atorvastatin)

    Mevacor(lovastatin)

    Altoprev(lovastatin,extended-release)

    Pravachol(pravastatin)

    Vytorin(ezetimibe/simvastatin)

    Zocor(simvastatin)

    Simcor(niacinER/simvastatin)

    Livalo(pitavastatin)

    Gemfibrozil x xb x x xd x xf xf x

    HIV Protease Inhibitors xb x x xf xf x

    Niacin (1g/day) x x x x xd x x x x

    Amlodipine xg xg

    Diltiazem x x x xe xe

    Verapamil x x xc xe xe

    Grapefruit Juice

    (> 1 quart/day)x x x x

    Rifampin xi

    aCrestor dose should not exceed 5 mg/daybCrestor dose should not exceed 10 mg/daycLovastatin dose should not exceed 40 mg/daydLovastatin dose should not exceed 20 mg/daye

    Simvastatin dose should not exceed 10 mg/day

    fUse with simvastatin is contraindicatedgSimvastatin dose should not exceed 20 mg/dayhPitavastatin dose should not exceed 1 mg/dayiPitavastatin dose should not exceed 2 mg/day

    Some of the common adverse effects associated with statins include headache, constipation and

    abdominal pain. Statins are contraindicated in patients with acute liver disease or unexplained persistent

    elevations of serum transaminases. They are also contraindicated during pregnancy (Category X). All

    statins have the potential to cause persistent elevations in serum transaminases. Liver function tests

    should be performed prior to initiation of statin therapy, particularly in patients with a history of liver

    disease, and when otherwise clinically indicated.

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    Summary of Recommendations

    Proper disease management will help reduce the risk and burden of coronary heart disease and

    maximize your patients overall well-being. Please consider a lipoprotein profile test or statin therapy

    in your patient as clinically appropriate for the management of hyperlipidemia.

    References:

    1. Cholesterol Statistics. American Heart Association Web site. http://www.americanheart.org/presenter.jhtml?identier=4506.

    Accessed February 19, 2010.

    2. Third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high

    blood cholesterol in adults (ATP III Final Report). National Heart, Lung, and Blood Institute, National Institutes of Health Web site.

    http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm. Accessed November 29, 2010.

    3. American Diabetes Association. Standards of medical care in diabetes 2010. Diabetes Care.2010;33(suppl 1):S11-S61.

    4. Micromedex Web site. http://www.thomsonhc.com/ Accessed November 29, 2010.

    5. FDA News Release. FDA announces new safety recommendations for high-dose simvastatin. United States Food and Drug

    Administration web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258338.htm. Accessed June 8, 2011.

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