Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indications¹

Lipitor® is indicated:

As an adjunct to diet to reduce elevated total cholesterol, low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B) and triglyceride (TG) levels; and for increasing high-density lipoprotein-cholesterol (HDL-C) in patients with:
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Combined/mixed hyperlipidemia (Fredrickson Types IIa and IIb)
- Elevated serum TG levels (Fredrickson Type IV)
- Dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet
For the reduction of total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia when response to diet and other non-pharmacological measures are inadequate
For the prevention of cardiovascular (CV) complications to reduce the risk of:
- Myocardial infarction (MI), stroke, revascularization procedures and angina in adult patients without clinically evident coronary heart disease (CHD) but with multiple risk factors for CHD
- MI and stroke in type 2 diabetic patients without CHD but with multiple risk factors for CHD
- Nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure and angina in patients with clinically evident CHD
As an adjunct to reduce total cholesterol, LDL-C and apo B in boys and post-menarchal girls aged 10–17 years with heterozygous familial hypercholesterolemia after an adequate trial of diet therapy

Clinical Evidence

ASCOT-LLA study
Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial.

Atorvastatin 10 mg produced a significant reduction in fatal CHD and nonfatal MI²

CARDS study
Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial.

Atorvastatin 10 mg substantially reduced the risk of major CV events by 37% in patients with type 2 diabetes with no history of CV disease and without high LDL cholesterol concentration³
- 48% risk reduction in stroke
- 27% risk reduction in total mortality
Atorvastatin was well tolerated and effective in reducing the risk of first CV events in patients with type 2 diabetes and without high LDL-C levels³

CARDS Study sub-analysis
Effects of Atorvastatin on Kidney Outcomes and Cardiovascular Disease in Patients With Diabetes: An Analysis From the Collaborative Atorvastatin Diabetes Study (CARDS)

According to the NKF, diabetes is one of the main causes of CKD. Patients with diabetes and patients with CKD are at a high risk for CV events, according to NKF KDOQI/ADA guidelines.⁴
In a post hoc subanalysis of CARDS in patients with type 2 diabetes and CKD (n=482), LIPITOR 10 mg provided 42% RRR in the primary endpoint of major CV events compared with placebo (P=.03) including a 61% reduction in stroke.⁵
- No differences were seen in the evaluated safety parameters, including renal parameters, between the population of this post hoc subanalysis and the overall CARDS population.⁵
- No difference in the effect on albuminuria was seen with LIPITOR 10 mg vs placebo in this post hoc subanalysis.⁵
LIPITOR requires no dose adjustments in patients with renal dysfunction which is supported by the NKF KDOQI guidelines for diabetes and CKD management. ⁴

TNT Study
Treating to New Targets - Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease

Atorvastatin 80 mg provided a significant 22% relative risk reduction in the primary endpoint of major CV events over 4.9 years versus atorvastatin 10 mg⁶
- 25% relative risk reduction of first fatal or nonfatal stroke (p=0.02)
- 22% relative risk reduction of nonfatal, non-procedure-related MI or death from CHD (p<0.001)

REVERSAL study
Reversal of Atherosclerosis with Aggressive Lipid Lowering

Atorvastatin 80 mg significantly reduced progression of atherosclerosis compared with a more moderate regimen of pravastatin 40 mg⁷

SPARCL study
The Stroke Prevention by Aggressive Reduction in Cholesterol Levels

Atorvastatin 80 mg daily reduced the risk of subsequent stroke in patients without known CHD and with cholesterol levels of 100 to 190 mg/dL who had a recent stroke or transient ischemic attack⁸

ARMYDA-RECAPTURE study
Efficacy of Atorvastatin Reload in Patients on Chronic Statin Therapy Undergoing Percutaneous Coronary Intervention: Results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial.

Pre-treatment (12 hours prior) with atorvastatin 80 mg followed by further 40 mg pre-procedural dose was associated with 50% risk reduction in major adverse cardiac events by day 30 compared with placebo⁹

Safety Profile¹

ADVERSE REACTIONS: Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; dyspepsia, nausea, flatulence, constipation, diarrhea; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; headache, asthenia, abdominal pain; nightmares; blurred vision; tinnitus; hepatitis, cholestasis; urticaria; muscle fatigue, neck pain; malaise, pyrexia.

INTERACTIONS: Risk of myopathy increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals or niacin; decreased atorvastatin plasma concentrations with oral antacid suspension containing magnesium and aluminum hydroxides, and colestipol; increased steady-state plasma digoxin concentration; increased atorvastatin plasma concentration with erythromycin and clarithromycin and protease inhibitors; increased area under the curve (AUC) values for norethindrone and ethinylestradiol.

Dosages¹

Recommended starting dose: 10 or 20 mg od; patients who require a large reduction in LDL-C (more than 45%) may be started at 40mg od; dosage range is 10 to 80 mg od; doses may be given at any time of the day with or without food; dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response; after initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Primary hypercholesterolemia and combined (mixed) hyperlipidemia: 10 mg od.

Heterozygous familial hypercholesterolemia (children 10–17 years): Initially 10 mg/day; maximum dose of 20 mg/day; adjustments at ≥4-week intervals.

Homozygous familial hypercholesterolemia: Usually 80 mg.

Strengths¹

10 mg, 20 mg, 40 mg, 80 mg

Packing¹

Tablets: 10 mg x 30’s, 20 mg x 30’s, 40 mg x 30’s, 80 mg x 30’s

Important Safety Information

CONTRAINDICATIONS: Lipitor® is contraindicated in patients with hypersensitivity to any component of the drug; active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal; in women who are pregnant, breastfeeding, or of child-bearing potential and are not using adequate contraception.

SPECIAL PRECAUTIONS: Perform liver function tests before initiating treatment and periodically thereafter; patients who consume substantial quantities of alcohol and/or have a history of liver disease; discontinue drug if markedly elevated creatine phosphokinase (CPK) levels occur or myopathy is diagnosed or suspected; acute, serious condition suggestive of myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis .

ADVERSE REACTIONS: Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; dyspepsia, nausea, flatulence, constipation, diarrhea; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; headache, asthenia, abdominal pain; nightmares; blurred vision; tinnitus; hepatitis, cholestasis; urticaria; muscle fatigue, neck pain; malaise, pyrexia .

POST-MARKETING ADVERSE REACTIONS: Thrombocytopenia; allergic reactions; tendon rupture; weight gain; hypoesthesia, amnesia, dizziness, dysgeusia; Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, bullous rashes; rhabdomyolysis, back pain; chest pain, peripheral edema, fatigue.

PREGNANCY and LACTATION: Lipitor® is contraindicated in pregnant and breastfeeding women. Women of child-bearing potential should use adequate contraceptive measures. It should only be administered to women of child-bearing age when conception is highly unlikely and the patient is informed of the potential hazards to the fetus.

Please refer to the full prescribing information for more safety information.

References

1. Lipitor® (atorvastatin calcium) Prescribing Information. Pfizer Corporation Hong Kong Limited: 5 June 2009.

2. Sever PS, Dahlof B, Poulter NR, et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003;361(9364):1149–1158.

3. Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;364(9435):685–696.

4. National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis 2007;49(2 Suppl 2):S12–154.

5. Colhoun HM, Betteridge DJ, Durrington PN, et al. Effects of atorvastatin on kidney outcomes and cardiovascular disease in patients with diabetes: an analysis from the Collaborative Atorvastatin Diabetes Study (CARDS). Am J Kidney Dis 2009;54(5):810–819.

6. LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352(14):1425–1435.

7. Nissen SE, Tuzcu EM, Schoenhagen P, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA 2004;291(9):1071–1080.

8. Amarenco P, Bogousslavsky J, Callahan A, III, et al. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006;355(6):549–559.

9. Di SG, Patti G, Pasceri V, et al. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol 2009;54(6):558–565.

Please review the full product information or package insert before prescribing.

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