Navigation

Statin Therapy Management

Patients with risk factors for coronary heart disease but no history of disease who receive lipid-lowering therapy are likely to experience a decreased risk of coronary heart disease. [Conclusion Grade I: See Conclusion Grading Worksheet A – Annotation #8 (Drug Therapy)] (ALLHAT, 2002 [A]; Downs, 1998 [A]; Frick, 1987 [A]; Heart Protection Study Collaborative Group, 2002 [A]; Lipid Research Clinics Program, 1984 [A]; Pignone, 2000 [M]; Sever, 2003[A]; Shepherd, 2002 [A]; Shepherd, 1995 [A]).

Patients with a history of coronary disease (including unstable angina and acute myocardial infarction) often benefit from treatment with a statin. Studies have consistently shown a decrease in risk of death from coronary heart disease [Conclusion Grade I: See Conclusion Grading Worksheet B Annotation #8 Drug Therapy(Cannon, 2004 [A]; Goldberg, 1998 [A]; Heart Protection Collaborative Study, 2002 [A]; LaRosa, 1999 [M]; LIPID Study Group, 1998 [A]; Nissen, 2004 [A]; Scandinavian Simvastatin Survival Study Group, 1994 [A]; Shepherd, 2002 [A]).


Specific statin and dose should be selected based on cost and amount of lipid-lowering required.  See Appendix C, "Drug Companion Document" for additional information. 


Thus, for care of patients with established CHD or CHD risk equivalent (which includes occlusive carotid disease, peripheral vascular disease, abdominal aortic aneurysm, or diabetes), the use of statin therapy is recommended.
  • Bedtime or evening dose of statin is more effective (higher cholesterol synthesis).
  • To maximize absorption, lovastatin needs to be taken with food, but lovastatin SR should be taken on an empty stomach.
  • Use of fibrates in conjunction with thiazolidinediones may cause an major decrease in HDL levels in some patients.  It may be advisable to check an HDL value 1-2 months after initiating this combination of medications (Mymin, 2009 [D]; Normen, 2004 [D]).
  • Dosage adjustments should not be made more often than every four weeks after a fasting lipid panel.
  • Please consult manufacturer's product label insert, PDR, etc., for full prescribing information.

Safety Considerations in Prescribing Statins in Primary Care Settings

DO
c  Check baseline renal function and thyroid function (TSH) prior to initiating statin therapy.

c  Check ALT or AST levels prior to prescribing a statin and after any planned increase in statin dose.

c  Consider the potential for drug-drug interactions when prescribing statins.  Vitamin E intake may reduce the benefit of statins.

c  Be alert for patient characteristics that may increase the risk for myopathy during statin therapy, such as advanced age (particularly elderly
        women), renal or liver impairment, diabetes with evidence of hepatic fatty changes, hypothyroidism, drugs of abuse (amphetamines,
        phencyclidine, heroin, cocaine), surgery, trauma, ischemia-reperfusion, debilitated status, excessive alcohol intake, heavy exercise.

c  Provide patient education regarding recognition and reporting of symptoms of myopathy during statin therapy.

c  Counsel patients to discontinue statin therapy during a short course of a macrolide or ketolide antibiotic (e.g., azithromycin, clarithromycin,
        erythromycin, or telithromycin).

c  Suspect myopathy when a statin-treated patient complains of unexplained, generalized muscle pain, tenderness or weakness.  Joint pain,
        nocturnal leg cramps, or localized pain are not symptoms of myopathy.

c  Check CK levels when a patient reports symptoms of myopathy.

c  If CK levels are less than five times upper limit of normal, repeat measurement in one week.

c  If CK levels are elevated to five times upper limit of normal or greater, discontinue statin therapy and monitor serum CK levels.

c  Assess for signs of dehydration or renal compromise in patients with myopathy.

c  Consider referral for patients requiring combination lipid-lowering therapy, or document the need for this therapy, such as lack of response to
        monotherapy in a high-risk patient.

c  When adding a statin to the regimen of a patient already receiving a fibrate, initiate at the lowest starting dose of statin.

c  Consider the differences in pharmacokinetic profiles among statins, particularly in patients requiring long-term therapy with drugs that are
        CYP3A4 substrates, inhibitors or both.

DON'T

c Prescribe statin-fibrate combination therapy in patients with the following conditions:  impaired liver or renal function (creatinine level greater
        than 2.0 mg/dL), cyclosporine or tacrolimus therapy, long-term macrolide antibiotic therapy or azole antifungal therapy, advanced age (greater
        than 70 years), skeletal muscle conditions.

c Prescribe high-dose statin therapy for elderly patients and patients with renal insufficiency, or in combination with fibrates or cyclosporine.

c Vitamin E may reduce the benefit of statins or of statin-niacin combination therapy.  Vitamin E does not appear to reduce the risk of major
        cardiovascular events.

c Use of fibrates in conjunction with thiazolidinediones may cause an major decrease in HDL levels in some patients.  It may be advisable to
        check an HDL value 1-2 months after initiating this combination of medications.  
 
    (Ballantyne, 2003 [R]; Heart Protection Study Collaborative Group, 2002 [A])