Sie sind auf Seite 1von 8
Prescribing Focus: Statins for the Management of Hyperlipidemia Introduction It is estimated that 102.2 million

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. 1 Statins—or HMG-CoA reductase inhibitors—have demonstrated the ability to reduce the risk of adverse CV events in diverse patient populations. This Prescribing Focus offers recommendations for the management of hyperlipidemia with statin therapy to decrease morbidity and mortality in your patients with CV risk.

Lipoprotein Profile Testing in Adults 2

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-C goal of <100 mg/dL. Measuring lipoprotein levels will help guide treatment and selection of appropriate cholesterol-lowering drug therapies.

Use of Statins for Hyperlipidemia 2

The NCEP ATP III guideline recommends treatment of high blood cholesterol in adults, based on low- density lipoprotein cholesterol (LDL-C) levels and a patient’s absolute risk for cardiovascular disease. Both short-term (10-year) risk and long-term risk must be considered for treatment decisions. Those with existing CHD, or CHD risk equivalent, are at the highest risk and require stringent LDL-C control.

For the full summary of the NCEP ATP III guideline for the management of hyperlipidemia, please visit

http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm.

The American Diabetes Association also encourages an aggressive treatment of diabetic dyslipidemia to reduce the risk of cardiovascular disease (CVD). Statins should be the first-line consideration for therapy.

A cholesterol absorption inhibitor or a resin, niacin, or fenofibrate may be added if necessary to reach

the LDL-C goal or in the case of statin intolerance.

Selecting a Statin for Your Patient 4

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

• The extent of each statin’s ability to lower LDL-C levels and raise HDL-C levels (Table 1)

• Drug interactions between statins and your patient’s 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 patient’s 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

 

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

 

Drug Name and Dosage

LDL-C

HDL-C

TG

Combination Products

 

Advicor® (niacin ER/lovastatin)

 
 

-47 (women)

+ 33 (women) +24 (men)

-48 (women)

2000 mg/40 mg QHS

-34 (men)

-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.

Table 2. Myopathy and Rhabdomyolysis Drug-Drug Interactions 4,5

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

Advicor (niacin ER/lovastatin)

 

Lescol (fluvastatin) Lescol XL (fluvastatin, extended-release)

 

(amlodipine/atorvastatin)

Mevacor (lovastatin) Altoprev (lovastatin, extended-release)

 

Vytorin (ezetimibe/simvastatin)

 

(niacin ER/simvastatin)

 

Drug

Crestor (rosuvastatin)

Lipitor (atorvastatin)

Pravachol (pravastatin)

Zocor (simvastatin)

Livalo (pitavastatin)

Caduet

Simcor

Amiodarone

x

     

x

c

 

x

e

x

e

 

Itraconazole

x

 

x

x

x

 

x

f

x

f

 

Ketoconazole

x

 

x

x

x

 

x

f

x

f

 

Posaconazole

x

 

x

x

x

 

x

f

x

f

 

Cyclosporine

 

x

a

x

x

x

d

x

x

f

x

f

x

Macrolides

                 

(clarithromycin

x

x

x

x

f

x

f

x

h

erythromycin)

     

Fenofibrate

x

x

b

x

x

x

d

x

x

x

x

a Crestor dose should not exceed 5 mg/day b Crestor dose should not exceed 10 mg/day c Lovastatin dose should not exceed 40 mg/day d Lovastatin dose should not exceed 20 mg/day e Simvastatin dose should not exceed 10 mg/day

f Use with simvastatin is contraindicated g Simvastatin dose should not exceed 20 mg/day h Pitavastatin dose should not exceed 1 mg/day i Pitavastatin dose should not exceed 2 mg/day

Interacting

Advicor (niacin ER/lovastatin)

 

Lescol (fluvastatin) Lescol XL (fluvastatin, extended-release)

 

(amlodipine/atorvastatin)

Mevacor (lovastatin) Altoprev (lovastatin, extended-release)

 

Vytorin (ezetimibe/simvastatin)

 

(niacin ER/simvastatin)

 

Drug

Crestor (rosuvastatin)

Lipitor (atorvastatin)

Pravachol (pravastatin)

Zocor (simvastatin)

Livalo (pitavastatin)

Caduet

Simcor

Gemfibrozil

x

x

b

x

x

x

d

x

x

f

x

f

x

HIV Protease Inhibitors

 

x

b

 

x

x

 

x

f

x

f

x

Niacin (1g/day)

x

x

x

x

x

d

x

x

x

x

Amlodipine

           

x

g

x

g

 

Diltiazem

x

   

x

x

 

x

e

x

e

 

Verapamil

x

   

x

x

c

 

x

e

x

e

 

Grapefruit Juice (> 1 quart/day)

     

x

x

 

x

x

 

Rifampin

               

x

i

a Crestor dose should not exceed 5 mg/day b Crestor dose should not exceed 10 mg/day c Lovastatin dose should not exceed 40 mg/day d Lovastatin dose should not exceed 20 mg/day e Simvastatin dose should not exceed 10 mg/day

f Use with simvastatin is contraindicated g Simvastatin dose should not exceed 20 mg/day h Pitavastatin dose should not exceed 1 mg/day i Pitavastatin 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.

Summary of Recommendations

Proper disease management will help reduce the risk and burden of coronary heart disease and maximize your patient’s 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?identifier=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.

2300 Main Street, Irvine, CA 92614 • PrescriptionSolutions.com PS3101_PRX_110401 ©2011 Prescription Solutions. Any

2300 Main Street, Irvine, CA 92614 • PrescriptionSolutions.com

PS3101_PRX_110401

©2011 Prescription Solutions. Any unauthorized reproduction, dissemination or use of this document is strictly prohibited.