Close Window
Aetna
Aetna Aetna
Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Antilipidemic Agents - HMG CoA Reductase Inhibitors

Status Drug PR PR-QL PR-AL ST M EX‡
P Advicor®  (lovastatin/niacin ER)   X      
P Lescol XL®  (fluvastatin ER)   X      
P Lescol®  (fluvastatin)   X      
P lovastatin   X      
P pravastatin   X      
P simvastatin   X      
P Crestor®  (rosuvastatin)   X      
P Crestor® 5mg  (rosuvastatin)   X   X X
P Vytorin®  (ezetimibe/simvastatin)   X      
P Vytorin® 10/10mg  (ezetimibe/simvastatin)   X   X X
P Zetia®  (ezetimibe)   X      
FE Altoprev® (was Altocor)  (lovastatin ER)   X   X X
FE Caduet®  (atorvastatin/amlodipine)   X   X X
FE Lipitor®  (atorvastatin)   X   X X
FE Mevacor®  (lovastatin)   X   X X
FE Pravachol®  (pravastatin)   X   X X
FE Zocor®  (simvastatin)   X   X X


Policy:

  1. Precertification Criteria

    2. Under some plans, including plans that use an open or closed formulary, Advicor, Altoprev, Caduet, Crestor, Lescol, Lipitor, lovastatin, Mevacor, Pravachol, pravastatin, simvastatin, Vytorin, Zetia and Zocor are subject to precertification.  If precertification requirements apply Aetna considers Advicor, Altoprev, Caduet, Crestor, Lescol, Lipitor, lovastatin, Mevacor, Pravachol, pravastatin, simvastatin, Vytorin, Zetia and Zocor to be medically necessary for those members who meet the following precertification criteria:

    According to the manufacturer, the HMG CoA reductase inhibitors and Zetia can be dosed up to a maximum daily dose at the interval(s) as  indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below if member fulfills criteria A or B above:

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Advicor 2000/40 mg/ once or twice daily 500/20 mg, 750/20 mg, 1000/20 mg 1000/40mg Up to 60 tablets in 30 days
    Altoprev (was Altocor) 60 mg/ once daily 10 mg, 20 mg Up to 30 tablets in 30 days
    Altoprev (was Altocor) 60 mg/ once daily 40 mg Up to 30 tablets in 30 days
    Altoprev (was Altocor) 60 mg/ once daily 60 mg Up to 30 tablets in 30 days
    Caduet 10/80 mg/ once daily 2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80 Up to 30 tablets in 30 days
    Crestor 40 mg/ once daily 5, 10, 20 mg Up to 30 tablets in 30 days
    Crestor 40 mg/ once daily 40 mg Up to 30 tablets in 30 days
    Lescol 80 mg/ twice daily 20 mg, 40 mg Up to 60 tablets in 30 days
    Lescol XL 80 mg/ once daily 80 mg Up to 30 tablets in 30 days
    Lipitor 80 mg/ once daily 10, 20, 40 mg Up to 30 tablets in 30 days
    Lipitor 80 mg/ once daily 80 mg Up to 30 tablets in 30 days
    lovastatin 80 mg/ twice daily 10, 20 mg Up to 60 tablets in 30 days
    lovastatin 80 mg/ twice daily 40 mg Up to 60 tablets in 30 days
    Mevacor 80 mg/ twice daily 10, 20 mg Up to 60 tablets in 30 days
    Mevacor 80 mg/ twice daily 40 mg Up to 60 tablets in 30 days
    pravastatin Pravachol 80 mg/ once daily 10, 20 mg Up to 30 tablets in 30 days
    pravastatin Pravachol 80 mg/ once daily 40 mg Up to 60 tablets in 30 days
    pravastatin Pravachol 80 mg/ once daily 80 mg Up to 30 tablets in 30 days
    Vytorin 10mg/80mg/ once daily 10-10, 10-20, 10-40, and 10-80 mg Up to 30 tablets in 30 days
    Zetia 10 mg/ once daily 10 mg Up to 30 tablets in 30 days
    simvastatin Zocor 80mg/ once daily 5, 10, 20, 40 mg Up to 30 tablets in 30 days
    simvastatin Zocor 80 mg/ once daily 80 mg Up to 30 tablets in 30 days


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of HMG CoA reductase inhibitors will be considered medically necessary for those members who meet ANY of the following criteria:

    • Member requires a dose including half tablets OR
    • Member's dose is being titrated by physician (3-month limit) OR
    • Member has had intolerance to drug administered as a single daily dose OR
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.


  2. Step Therapy Criteria

    3. Under some plans, including plans that use an open or closed formulary, Altoprev, Caduet, Crestor 5mg, Lipitor, Mevacor, Pravachol, Vytorin 10/10 mg and Zocor are subject to step-therapy.  Aetna considers Altoprev, Caduet, Crestor 5mg, Lipitor, Mevacor, Pravachol, Vytorin 10/10 mg and Zocor to be medically necessary for those members who meet step-therapy criteria as specified below:

    For Lipitor (40mg or higher)
    A documented trial of one month EACH of the preferred Vytorin at a dose >10/10 mg/day AND Crestor at a dose of 10 mg/day or higher.

    For Crestor 5mg
    A documented trial of one month of the preferred generic alternative, simvastatin at a dose of 40 mg/day or higher

    For Altoprev, Mevacor
    A documented trial of one month of the preferred generic alternative lovastatin (any strength)

    For Lipitor (10mg, 20mg)
    A. A documented trial of one month of Lescol/Lescol XL (at a dose of 40mg/day or higher) OR lovastatin (at a dose of 20mg/day or higher) OR Advicor (any dose), OR pravastatin (at a dose of 40 mg/day or higher), OR simvastatin (at a dose of 40mg/day or higher)
    AND
    B. Vytorin AND/OR Crestor - alternatives on the Preferred Drug List.

    Note: Failure of ONE agent from A AND ONE agent from B
              OR
              Failure of TWO agents from B meets criteria.

    For Caduet
    A documented trial of one month of concurrent use of  both Norvasc/amlodipine AND one of the following: Lipitor (any dose) OR Vytorin (any dose) OR Crestor (at a dose of 10 mg/day or higher) OR Zocor/ simvastatin (at a dose of 40mg/day or higher); Vytorin, Crestor and simvastatin are alternatives on the Preferred Drug List.

    For Pravachol

    A documented trial of one month of the preferred generic equivalent pravastatin on the Preferred Drug List.

    For Vytorin 10/10 mg
    A documented trial of one month of the preferred generic alternative, simvastatin at a dose of 40 mg day or higher.

    For Zocor
    A documented trial of one month of the preferred generic equivalent simvastatin on the Preferred Drug List


    If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)

  3. Medical Exception Criteria

    4.  

    Altoprev, Caduet, Lipitor, Mevacor, Pravachol, and Zocor are currently listed on the Aetna Formulary Exclusions List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Altoprev, Caduet, Lipitor, Mevacor, Pravachol and to be medically necessary for those members who meet the criteria as specified below:

     

    Crestor 5mg and Vytorin 10/10mg are currently listed on the Aetna Step Therapy List.* If it is medically necessary for a member to be treated initially with Crestor 5mg or Vytorin 10/10mg, Aetna considers Crestor 5mg or Vytorin 10/10mg  to be medically necessary for those members who meet the criteria specified below:

     

    For Lipitor (40mg or higher) – A OR B OR C

     

                                                                     A.            Member has a documented:

    §         Contraindication to the preferred alternatives Crestor AND Vytorin or one of it’s components OR

    §         Intolerance to the preferred alternatives Crestor AND Vytorin or one of it’s components OR

    §         Allergy to the preferred alternatives, Crestor AND Vytorin or one of it’s components OR

    §         Failure of an adequate trial of one month EACH of the preferred alternatives, Crestor AND Vytorin  

                                                                     B.            Member is receiving another medication with a potentially clinically significant drug interaction with Crestor: cyclosporine (Neoral, Sandimmune), warfarin (Coumadin), and gemfibrozil (Lopid)

                                                               

    OR

                                                                     C.            Member receiving another medication with a potentially clinically significant drug interaction with Vytorin or Zocor or simvastatin

     

    Potentially interacting drugs include, but are not limited to: gemfibrozil (Lopid), fenofibrate (Tricor), niacin (dose > 1 gram/day); verapamil; amiodarone (Cordarone); cyclosporine (Neoral, Sandimmune); itraconazole (Sporanox); ketoconazole (Nizoral); danazol; erythromycin; clarithromycin (Biaxin); telithromycin (Ketek); nefazodone (Serzone); warfarin (Coumadin); ranolazine (Ranexa); HIV reverse transcriptor inhibitors: such as Zerit (stavudine or d4T) and HIV protease inhibitors: such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase); tipranavir (Aptivus).

     

    For Altoprev and Mevacor –

     

    A.         Member has a documented:

    §         Contraindication to the preferred alternative lovastatin OR

    §         Intolerance to the preferred alternative lovastatin OR

    §         Allergy to the preferred alternative lovastatin OR

    §         Failure of an adequate trial of one month of the preferred alternative, lovastatin (any strength)

     

    For Lipitor (10mg, 20mg) – A OR B


    A.    Member has a documented:

    §        Contraindication to TWO* preferred alternatives;  [lovastatin or simvastatin or pravastatin or Advicor or Lescol/Lescol XL or Zetia] AND/OR  Vytorin AND/OR Crestor OR

    §         Intolerance to TWO*  preferred alternatives: [lovastatin or simvastatin or pravastatin or Advicor or Lescol/Lescol XL or Zetia] AND/OR  Vytorin AND/OR Crestor OR

    §         Allergy to TWO* preferred alternatives [lovastatin or simvastatin or pravastatin or Advicor or Lescol/Lescol XL or Zetia] AND/OR  Vytorin AND/OR Crestor OR

    §         A documented failure of one month trial of TWO* (preferred alternatives ;[Lescol/Lescol XL (at a dose of 40 mg/day or higher) OR lovastatin (at a dose of 20 mg/day or higher) OR Advicor (any dose), OR pravastatin (at a dose of 40 mg/day or higher), OR simvastatin (at a dose of 40 mg/day or higher) or Zetia]
    AND/OR Vytorin AND/OR Crestor

     

    * = one of these agents [lovastatin or simvastatin or pravastatin or Advicor or  Lescol/Lescol XL or Zetia]  AND one of these agents:

        Vytorin or Crestor

    OR

    Both of these agents:  Vytorin AND Crestor          

     

                   OR

    A.     Member is receiving another medication with a potentially clinically significant drug interaction with simvastatin - Lipitor (10mg, 20mg) ONLY

    Potentially interacting drugs include, but are not limited to: gemfibrozil (Lopid), fenofibrate (Tricor), niacin (dose > 1 gram/day); verapamil; amiodarone (Cordarone); cyclosporine (Neoral, Sandimmune); itraconazole (Sporanox); ketoconazole (Nizoral); danazol; erythromycin; clarithromycin (Biaxin); telithromycin (Ketek); nefazodone (Serzone); warfarin (Coumadin); ranolazine (Ranexa); HIV reverse transcriptor inhibitors: such as Zerit (stavudine or d4T) and HIV protease inhibitors: such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase); tipranavir (Aptivus).

     

    For Caduet – A, B, or C

     

    A.     Member is documented to be receiving both amlodipine (Norvasc) AND atorvastatin (Lipitor).

    OR

    B.     Member is documented to be currently on Caduet.

     

         OR

     

    C.     Member is receiving amlodipine (Norvasc) and has a documented:

    §         Contraindication to one of the alternatives, Vytorin, Crestor, or Zocor/simvastatin OR

    §         Intolerance to one of the alternatives, Vytorin, Crestor, or Zocor/simvastatin OR

    §         Allergy to one of the alternatives, Vytorin, Crestor or Zocor/simvastatin OR

    §         Failure of an adequate trial of one month of one of the  alternatives, Crestor (at a dose of 10 mg/day or higher), Vytorin or Zocor/simvastatin (at a daily dose of 40 mg or higher); Vytorin, Crestor and simvastatin are alternatives on the Preferred Drug List

     

    For Pravachol

    A.          Member has a documented:

    §         Contraindication to the preferred generic equivalent, pravastatin OR

    §         Intolerance to the preferred generic equivalent, pravastatin OR

    §         Allergy to the preferred generic equivalent, pravastatin OR

    §         Failure of an adequate trial of one month of the preferred generic equivalent, pravastatin

     

    For Zocor –A only

    A.     Member has a documented:

    §         Contraindication to the preferred generic equivalent, simvastatin OR

    §         Intolerance to the preferred generic equivalent, simvastatin OR

    §         Allergy to the preferred generic equivalent, simvastatin OR

    §         Failure of an adequate trial of one month of the preferred generic equivalent, simvastatin

    For Crestor 5mg and Vytorin 10/10 mg – only (A or B)

    A.         Member has a documented:

    §         Contraindication to the preferred generic alternative - simvastatin OR

    §         Intolerance to the preferred generic alternative – simvastatin
     OR

    §         Allergy to a preferred generic alternative, – simvastatin
    OR

    §         Failure of an adequate trial of one month ofthe preferred generic alternative, simvastatin at a dose of 40 mg/day or higher
    OR

    §         Member is of  Asian descent – Applies only to Crestor

    OR

    B.      Member is receiving another medication with a potentially clinically  significant drug interaction with simvastatin –

     

    Potentially interacting drugs include, but are not limited to: gemfibrozil (Lopid), fenofibrate (Tricor), niacin (dose > 1 gram/day); verapamil; amiodarone (Cordarone); cyclosporine (Neoral, Sandimmune); itraconazole (Sporanox); ketoconazole (Nizoral); danazol; erythromycin; clarithromycin (Biaxin); telithromycin (Ketek); nefazodone (Serzone); warfarin (Coumadin); ranolazine (Ranexa); HIV reverse transcriptor inhibitors: such as Zerit (stavudine or d4T) and HIV protease inhibitors: such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase); tipranavir (Aptivus).


Place of Service:

Outpatient

The above policy is based on the following references:
  1. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006
  2. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  3. DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
  4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006
  5. PDR® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006
  6. Grundy SM, Cleeman JI, Bairey CN, et al. for the Coordinating Committee of the National Cholesterol Edcation Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel II guidelines.  J Am Coll Cardiol. 2004;44:720-32.
  7. Heart Protection Study collaborative Group.  MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomized placebo-controlled trial.  Lancet. 2003;361:2005-16.
  8. Schuster H, Fox JC.  Investigating cardiovascular risk reduction – the rosuvastatin GALAXY programme.  Expert Opin Pharmacother.  2004;5:1187-1200.
  9. Nissen SE, Tuzcu EM, Schoenhagen P, et al., REVERSAL Investigators.  Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease.  N Eng J Med.  2005;352:29-38.
  10. Ridker PM, Cannon CP, Morrow D, et al., PROVE IT-TIMI 22 Investigators.  C-reactive protein levels and outcomes after statin therapy.  N Eng J Med.  2005;352:20-8.
  11. deLemos JA, Blazing MA, Wiviott SK, et al, for the A to Z Investigators.  Early intensive vs a delayed conservative simvastatin strategy in patients with cute coronary syndromes; phase Z of the A to Z trial.  MANA.  2004;292:1307-16.
  12. Davidson, MH, Safety Profiles for the HMG-CoA Reductase Inhibitors, Treatment and Trust, Adis Drugs, 2001; 61(2):197-206.
  13. Tafreshi MJ, Zagnoni LG, and Gentry EJ. Combination of clopidogrel and statins: A hypothetical interaction or therapeutic dilemma? Pharmacotherapy 2006;26:388-94.
  14. Blasetto JW, Stein EA, Brown WV, et al.  Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups.  Am J Cardiol.  2003;91(suppl):3C-10c.
  15. Scandinavian Simvastatin Survival Study Group.  Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-89.
  16. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH et. al.  Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia.  N Engl J Med 1995; 333: 1301-7.
  17. Sacks FM, Pfeffer Ma, Moye LA, et al.  The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels.  Cholesterol and Recurrent Events Trial investigators (CARE trial).  N Engl J Med. 1996;335:1001-9.
  18. West of Scotland Coronary Prevention Study Group.  Influence of pravastatin plasma lipids on clinical events in the West of Scotland Coronary Prevention Study (WOSCOPS). Circulation 1998;97:1440-5.
  19. Pedersen TR, Olsson AB, Faergeman O, et al.  Lipoprotein changes and reduction in the incidence of major coronary heart disease events in the Scandinavian Simvastatin Survival Study (4S). Circulation. 1998;97:1453-60.
  20. Downs, JR, et al., Primary Prevention of Acute Coronary Events with Lovastatin in Men and Women with Average Cholesterol Levels (AFCAPS/TexCAPS Research Group), JAMA, 1998;279(20):1615-1622.
  21. Prevention of Cardiovascular Events and Death with Pravastatin in Patients with Coronary Heart Disease and a Broad Range of Initial Cholesterol Levels.  The Long Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group, NEJM, 1998 Nov 5;339(19):1349-57.
  22. Sacks, FM, et al., Effect of Pravastatin on Coronary Disease Events in Subgroups Defined by Coronary Risk Factors, The Prospective Pravastatin Pooling Project, Circulation, 2000;102:1893-1900.
  23. Tonkin, AM, et al., for the LIPID Study Group, Effects of pravastatin in 3260 patients with unstable angina: results from the LIPID study, Lancet, 2000; 355:1871-75.
  24. Schwartz, GG, et al., for the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators, Effects of Atorvastatin on Early Recurrent Ischemic Events in Acute Coronary Syndromes, The MIRACL Study: A Randomized Controlled Trial, JAMA, April 4, 2001; 285(13):1711-1718.
  25. Heart Protection Study collaborative Group.  MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomized placebo-controlled trial.  Lancet. 2003;361:2005-16.
  26. TJ Smilde, et al., Effect of aggressive versus conventional lipid lowering on atherosclerosis progression in familial hypercholesterolaemia (ASAP): a prospective, randomised, double-blind trial, Lancet, 2001;357:577-81.
  27. Hunninghake DB, Ballantyne CM, Maccubbin DL, et al.  Comparative effects of simvastatin and atorvastatin in hypercholesterolemic patients with characteristics of metabolic syndrome.  Clin Ther.  2003;25:1670-86.
  28. Olsson AG, Eriksson M, Johnson O, et al. on behalf of the 3T Study Investigators.  A 52-week, multicenter, randomized, parallel-group, double-blind, double-dummy study to assess the efficacy of atorvastatin and simvastatin in reaching low-density lipoprotein cholesterol and triglyceride targets:  The Treat-to-Target (3T) Study.  Clin Ther.  2003;25:119-38.
  29. Ballantyne CM, Blazing MA, Hunninghake DB.  Effect on high-density lipoprotein cholesterol of maximum dose simvastatin and atorvastatin in patients with hypercholesterolemia: Results of the Comparative HDL Efficacy and Safety Study (CHESS).  Am Heart J.  2003;146:.
  30. Heart Protection Study collaborative Group.  MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomized placebo-controlled trial.  Lancet. 2003;361:2005-16.
  31. Brown WV, Bays HE, Hassman DR, et al.  Efficacy and safety of rosuvastatin compared with pravastatin and simvastatin in patients with hypercholesterolemia: a randomized, double-blind, 52-week trial.  Am Heart J.  2002;144:1036-43.
  32. Davidson M, ma P, Stein EA, et al.  Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia.  Am J Cardiol. 2002;89:268-75.
  33. Olsson AG, Istad H, Luurila O, et al.  Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia.  am Heart J.  2002;144:1044-51.
  34. Paoletti R, Fahmy M, Mahla G, et al.  Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolemic patients: a randomized, double-blind study.  J Cardiovasc Risk. 2001;8:383-90.
  35. Shepherd J, Hunninghake DB, Barter P, et al.  Guidelines for lowering lipids to reduce coronary artery disease risk: a comparison of rosuvastatin with atorvastatin, pravastatin, and simvastatin for achieving lipid-lowering goals. Am J Cardiol. 2003 Mar 6;91(5A):11C-17C
  36. McKinney JM, et al.  Comparison of the efficacy of rosuvastatin versus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial. Curr Med Res Opin. 2003;19(8):689-98.
  37. Schneck DW, Knopp RH, Ballantyne CM, et al.  Comparative effects of rosuvastatin and atorvastatin across their dose ranges in patients with hypercholesterolemia and without active arterial disease.  Am J Cardiol.  2003;91:33-41.
  38. Jones PH, Davidson MH, Stein EA, t al.  Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR trial).  Am J Cardiol.  2003;93:152-60.
    Stender S, Schuster H, Barter P, Watkins C, Kallend D; MERCURY I Study Group. Comparison of rosuvastatin with atorvastatin, simvastatin and pravastatin in achieving cholesterol goals and improving plasma lipids in hypercholesterolaemic patients with or without the metabolic syndrome in the MERCURY I trial. Diabetes Obes Metab. 2005;7(4):430-8.
  39. Heeschem, C, et al, on behalf of the Platelet Receptor Inhibition in Ischemic Syndrome Management (PRISM) Investigators, Withdrawal of Statins Increases Event Rates in Patients with Acute Coronary Syndromes, Circulation, March 26, 2002; 105:1446-1452.
  40. Ito MK, Talbert RL, Tsimikas S. Statin-associated pleiotropy: Possible beneficial effects beyond cholesterol reduction. Pharmacotherapy 2006;26(7 Pt 2):85S-97S.
  41. Waters DD. Safety of high-dose atorvastatin therapy. Am J Cardiol 2005;96 [Suppl]: 69F-75F.
  42. Jones PH and Davidson MH. Reporting rate of rhabdomyolysis with fenofibrate+statin versus gemfibrozil+any statin. Am J Cardiol 2005;95:120-2.
  43. Snow V, Aronson MD, Hornbake ER, et al for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Lipid control in the management of Type 2 diabetes mellitus: A clinical practice guideline from the American College of Physicians. Ann Intern Med. 2004;140:644-9.
  44. Johnson JL and Loomis IB. A case of simvastatin-associated pancreatitis and review of statin-associated pancreatitis. Pharmacotherapy 2006;26(3):414-22.
  45. Seehusen DA Asplund CA, Johnson DR, Horde K. Primary evaluation and management of statin therapy complications. South Med J. 2006;99(3):250-4.
  46. Silva MA, Swanson AC, Gandhi PJ, and Tataronis GR. Statin-related adverse events: A meta-analysis. Clinical Therapeutics 2006;28:26-35.
  47. Bottorff MB. Statin safety and drug interactions: Clinical implications. Am J Cardiol 2006;97[suppl]:27C-31C.
  48. Law M and Rudnicka AR. Statin safety: A systematic review. Am J Cardiol 2006;97[suppl]:52C-60C.
  49. Antons KA, Williams CD, Baker SK, Phillips PS. Clinical perspectives of statin-induced rhabdomyolysis. Am J Med. 2006;119(5):400-9.
  50. Haffner S. Rationale for new American Diabetes Association guidelines: Are national cholesterol education program goals adequate for the patient with diabetes mellitus? Am J Cardiol 2005;96[suppl]:33E-36E.
  51. Schwartz BM, Thompson PL, de Lemos JA, et al. Effects of early treatment with statins on short-term clinical outcomes in acute coronary syndromes: a meta-analysis of randomized controlled trials. JAMA. 2006;295(17):2046-56.
  52. Pedersen TR, Faergeman O, Kastelein JJP, Olsson AG, et al. High-dose atorvastatin vs. usual-dose simvastatin for secondary prevention after myocardial infarction. The IDEAL Study: A randomized controlled trial. JAMA 2005;294;2437-45.
  53. Packard CJ, Ford I, Robertson M, et al for the PROSPER Study Group. Plasma lipoproteins and apolipoproteins as predictors of cardiovascular risk and treatment benefit in the PROspective study of pravastatin in the elderly at risk (PROSPER). Circulation 2005;112:3058-65.
  54. Nissen SE. Halting the progression of atherosclerosis with intensive lipid lowering: results from the Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL) trial. Am J Med. 2005;118(12A):22S-27S.
  55. Rouleau J. Improved outcome after acute coronary syndromes with an intensive versus standard lipid-lowering regimen: results from the Pravastatin or Atorvastatin Evaluation and Infection Therapy—Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) trial. Am J Med 2005;118(12A):28S-35S.\
  56. Nissen SE. Effect of intensive lipid lowering on progression of coronary atherosclerosis: Evidence for an early benefit from the Reversal of Atherosclerosis with  Aggressive Lipid Lowering (REVERSAL) Trial. Am J Cardiol 2005;96[suppl]:61F-68F.
  57. Culhane NS, Lettieri SL, Skae J. Rosuvastatin for the treatment of hypercholesterolemia. Pharmacotherapy 2005;25(7):990-1000.
  58. Deedwania PC, Hunninghake DB, Bays HE. Effects of rosuvastatin, atorvastatin, simvastatin, and pravastatin on atherogenic dyslipidemia in patients with characteristics of the metabolic syndrome. Am J Cardiol 2005;95:360-6.
  59. Cowell SJ, Newby DE, Prescott RJ, et al for the Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) Investigators. A randomized trial of intensive lipid-lowering therapy in calcific aortic stenosis. N Engl J Med 2005;352:2389-97
  60. LaRosa JC, Grundy SM, Waters DD, et al for the Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425-35.
  61. Wanner C, Krane V, Marz W, et al. Atorvastatin in patients with Type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005;353-238-48.
  62. Schmermund A, Achenbach S, Buddle T, et al. Effect of intensive versus standard lipid-lowering treatment with atorvastatin on the progression of calcified coronary atherosclerosis over 12 months. A multicenter, randomized, double-blind trial. Circulation 2006;113:427-37.
  63. Nissen SE, Nicholls SJ, Sipahi I, et al for the ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis. The ASTEROID Trial. JAMA 2006;295:(doi:10.1001/jama.295.13.jpc60002).
  64. Ferdinand KC, Clark LT, Watson KE, et al for the ARIES Study Group. Comparison of efficacy and safety of rosuvastatin versus atorvastatin in African-American patients in a six-week trial. Am J Cardiol 2006;97:229-35.
  65. Mora S and Ridker PM. Justificatiion for the use of statins in primary prevention: An intervention trial evaluating rosuvastatin (JUPITER)—Can C-reactive protein be used to target statin therapy in primary prevention? Am J Cardiol 2006;97[suppl]:33A-41A.
  66. Ballantyne CM, Bertolami M, Hernandez, et al. Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring effective reductions in cholesterol using rosuvastatin therapy (MERCURY) II. Am Heart J 2006;151:975.e1-975.e9.
  67. Fletcher B, Berra K, Ades P, et al. Managing abnormal blood lipids: a collaborative approach. Circulation 2005;112(20):3184-209.
  68. Kale KM, Coleman CI, Henyan NN, et al. Statins and cancer risk, a meta-analysis. JAMA 2006;295:74-80.
  69. Briel M, Schwartz GG, Thompson PL, et al. Effects of early treatment with statins on short-term clinical outcomes in acute coronary syndromes. A meta-analysis of randomized controlled trials. JAMA 2006;295:2046-56.
  70. Keech BC, Kearney PM, Blackwell L, et al Cholesterol Treatment Trialists’ (CTT) Collaborators. Lancet 2005;366:1267-78.
  71. Boekholdt SM, Sacks FM, Jukema JW, et al. Cholesteryl ester transfer protein TaqIB variant, high-density lipoprotein cholesterol levels, cardiovascular risk, and efficacy of pravastatin treatment: Individual patient meta-analysis of 13,677 patients. Circulation 2005:111;278-87.
  72. Gotto AM. Review of primary and secondary prevention trials with lovastatin, pravastatin, and simvastatin. Am J Cardiol. 2005;96[suppl]:34F-38F.
  73. Newman C, Tsai J, Szarek M, et al. Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 1,4236 patients. Am J Cardiol. 2006;97:61-7.
  74. Zhou Z, Rahme E, Pilote L. Are statins created equal? Evidence from randomized trials of pravastatin, simvastatin, and atorvastatin for cardiovascular disease preventioin. Am Heart J. 2006;151:273-81.
  75. Costa J, Borges M, David C, and Carneiro A. Efficacy of lipid lowering drug treatment for diabetic and non-diabetic patients: meta-analysis of randomized controlled trials. BMJ 2006;332:115-24.
  76. Smith SC, Allen J, Blair SN, et al. AHA/ACC Guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update. Circulation. 2006;113:2363-2372.
  77. Schoenhagen P, Guzcu EM, Apperson-Hansen C, et al. Determinants of arterial wall remodeling during lipid-lowering therapy. Serial Intravascular ultrasound observations from the reversal of atherosclerosis with aggressive lipid lowering therapy (REVERSAL) trial. Circulation 2006. Published online before print June 12, 2006.
  78. Grundy SM, Cleeman JI, Bairey N, et al. Implications of recent clinical trials for the national cholesterol education program adult treatment panel III guidelines. Circulation. 2004;110:227-39
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 30, 2007
email this page   
Aetna
Skip Past Footer Links
Company Information   |   Site Map Aetna.com Home   |   Help   |   Contact Us   |   Search
Web Privacy Statement   |   Legal Statement   |   Privacy Notices   |   Member Disclosure

Back to top