LIPITOR^® Has Greater LDL-C Reductions in Every Dose:
Head-to-Head Study¹

LIPITOR^® vs Ezetimibe/Simvastatin

LIPITOR^® Has Established Evidence of CV Event Reduction Across a Wider Range of Patients Compared with Ezetimibe/Simvastatin^*†ǂ2-8

CV Outcome Trials

 

LIPITOR^® vs. Rosuvastatin

LIPITOR^® Has More CV Outcomes Data than Rosuvastatin^2-7,10-15

^*Ezetimibe/Simvastatin dose range is 10/10 mg/day to 10/80 mg/day. The risk of myopathy is greater in patients on ezetimibe/simvastatin 10/80 mg, therefore this dose should only be used in patients with severe hypercholesterolemia and at high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks.⁹

^†Based on target patient populations in each outcomes trial.

^ǂLIPITOR^® (atorvastatin calcium) is not currently approved for patients with established/documented CVD in Gulf countries (UAE, Bahrain, Oman, Qatar and Kuwait).

ACS: acute coronary syndrome; CV: cardiovascular; CHD; coronary heart disease; CKD: chronic kidney disease; LDL-C: low-density lipoprotein cholesterol; TIA:  transient ischemic attack.

 

LIPITOR^®Has an Established Safety Profile Across the Dose Range^1,2

 

Adapted from LIPITOR^® (atorvastatin calcium) Summary of Product Characteristics. January 2019 for UAE, Qatar, Iraq, Bahrain, Oman and June 2016 for Kuwait.¹; Newman C et al., Am J Cardiol, 2006²; CRESTOR^® Summary of Product Characteristics 2014³; ZOCOR^® Package Leaflet 2012⁴; INEGY^® Summary of Product Characteristics 2016.⁵

 

Diabetes Patient Safety
LIPITOR^®Demonstrates a Proven Safety Profile Across the Dose Range in Patients with Diabetes⁶

CARDS Safety Results in Patients with Type 2 Diabetes⁶

• In CARDS, the frequency of adverse events or serious adverse events did not differ between LIPITOR^® 10 mg and placebo.⁶

CARDS study design:⁶

• Double-blind, prospective study in which 2838 patients aged 40 to 75 years were randomized to LIPITOR^® 10 mg (n=1428) or placebo (n=1410)
• Patients had type 2 diabetes, no documented history of CVD, LDL-C ≤160 mg/dL, TG ≤600 mg/dL, and ≥1 of the following: hypertension, retinopathy, albuminuria, or current smoking
• The primary endpoint was time to first occurrence of acute CHD events, coronary revascularization, or stroke
• Median duration of follow-up was 4.0 years (IQR 3.0-4.7) in the atorvastatin group; the CARDS trial was terminated at 3.9 years to 2 years earlier than planned—due to highly significant benefits of atorvastatin

PLANET I Safety Results in Patients with Diabetes and CKD⁷

LIPITOR^® significantly reduced U_PCRat week 52 vs baseline⁷

*Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): Randomized, double-blind, parallel-group trial at 147 research centers including 353 patients with type 1 or type 2 diabetes aged 18 years or older with proteinuria (urine protein: creatinine ratio [UPCR] 500–5000 mg/g) and taking stable ACEIs, ARBs, or both. Patients were randomized to atorvastatin 80 mg (n=102), rosuvastatin 10 mg (n=107), or rosuvastatin 40 mg (n=116) for 52 weeks. The primary endpoint was change from baseline to week 52 of mean U_PCR in each treatment group.⁷

LIPITOR^® maintained eGFR at week 52 vs. baseline⁷

 

^*PLANET I study design:⁷

• Randomized, double-blind, parallel-group trial at 147 research centers
• Included 353 patients with type 1 or type 2 diabetes aged 18 years or older with proteinuria (U_PCR 500-5000 mg/g) and taking stable ACEIs, ARBs, or both
• Patients were randomized to atorvastatin 80 mg (n=102), rosuvastatin 10 mg (n=107), or rosuvastatin 40 mg (n=116) for 52 weeks
• The primary endpoint was change from baseline to week 52 of mean U_PCR in each treatment group

CKD Patient Safety

LIPITOR^®Has Demonstrated Safety in Patients With CKD, and Showed No Adverse Effect on eGFR Across the Dose Range^8-10

• No dose adjustment required in patients with renal impairment¹
• In PLANET I (n=353) in patients with moderate proteinuria, hypercholesterolemia, and diabetes, LIPITOR^® 80 mg had no adverse effect on proteinuria or estimated glomerular filtration rate (eGFR) at 52 weeks compared to baseline^7*
• According to 2019 ESC/EAS dyslipidemia guidelines, ‘the use of statins or statin/ezetimibe combination is indicated in patients with non-dialysis-dependent stage 3-5 CKD¹⁰

LIPITOR^®  80 mg reduced proteinuria and maintained eGFR in patients with CKD⁷

LIPITOR^® significantly reduced U_PCR at week 52 vs baseline⁷

    

†Prospective evaluation of proteinuria and renal function in nondiabetic patients with progressive renal disease (PLANET II): Randomized, double-blind, parallel-group trial at 114 research centers including 237 patients without diabetes, aged ≥18 years with proteinuria (urine protein: creatinine ratio [U_PCR] 500-5000 mg/g) and taking stable ACEIs, ARBs, or both. Patients were randomized to atorvastatin 80 mg (n=75), rosuvastatin 10 mg (n=65), or rosuvastatin 40mg (n=80) for 52 weeks. The primary endpoint was change from baseline to week 52 or mean UPCR in each treatment group.¹¹

 

   

 

^*PLANET I study design:⁷

• Randomized, double-blind, parallel-group trial at 147 research centers
• Included 353 patients with type 1 or type 2 diabetes aged 18 years or older with proteinuria (U_PCR 500–5000 mg/g) and taking stable ACEIs, ARBs or both
• Patients were randomized to atorvastatin 80 mg (n=102), rosuvastatin 10 mg (n=107) or rosuvastatin 40 mg (n=116) for 52 weeks
• The primary endpoint was change from baseline to week 52 of mean U_PCR in each treatment group

PLANET II study design:¹¹

• Randomized, double-blind, parallel-group trial at 114 research centers
• Included 237 patients without diabetes, aged ≥18 years with proteinuria (U_PCR 500-5000 mg/g) and taking stable ACEIs, ARBs or both
• Patients were randomized to atorvastatin 80 mg (n=75), rosuvastatin 10 mg (n=65) or rosuvastatin 40 mg (n=80) for 52 weeks
• The primary endpoint was change from baseline to week 52 or mean U_PCR in each treatment group

Asian Patient Safety

A Retrospective Analysis Assessed the Safety of LIPITOR^® in Asian Patients in 58 Randomized Trials¹²

Pharmacokinetic data (AUC and C_max) are similar between Asian and Caucasian patients¹³

Heritage

LIPITOR^®Has the Experience You Can Trust^6,8,14-23

*Proteinuria at baseline defined as urinary protein/creatinine excretion ratio of 500 to 5000 mg/g.⁷

ACEI: angiotensin converting enzymes inhibitor; ALT: alanine aminotransferase; ARB: angiotensin II receptor blocker; AST: aspartate aminotransferase; CARDS: Collaborative AtoRvastatin Diabetes Study; CHD: coronary heart disease; CK: creatine kinase; CKD: chronic kidney disease; CV: cardiovascular; CVD: cardiovascular disease; eGFR: estimated glomerular filtration rate; EAS: European Atherosclerosis Society; ESC: European Society of Cardiology; HDL-C: high-density lipoprotein cholesterol; IQR: interquartile range; LDL-C: low-density lipoprotein cholesterol; LOCF: last observation carried forward; MI: myocardial infarction; PLANET I: Renal Effects of Atorvastatin and Rosuvastatin in Patients with Diabetes who have Progressive Renal Disease; PLANET II: Prospective Evaluation of Proteinuria and Renal Function in Nondiabetic Patients With Progressive Renal Disease; RRR: relative risk reduction; TC: total cholesterol; TG: triglycerides; ULN: upper limit of normal; U_PCR: urine protein to creatinine ratio.

Hypertension + ≥3 Additional Risk Factors

In the ASCOT-LLA trial in patients with hypertension and ≥3 additional risk factors, LIPITOR^® 10 mg reduced the risk of nonfatal MI and fatal CHD by 36% compared with placebo¹

 

 

• LIPITOR^® 10 mg reduced mean LDL-C from 133 mg/dL (3.44 mmol/L) to 90 mg/dL (2.32 mmol/L) over the course of the study¹

Hypertension + ≥2 Additional Risk Factors

In an ASCOT-LLA post hoc subgroup analysis in patients with hypertension, diabetes, and ≥2 additional risk factors, LIPITOR^® 10 mg reduced the risk of total CV events and procedures by 23% compared with placebo²

        

Adapted from Sever PS et al. Diabetes Care.2005.

ASCOT-LLA Study design^1,2

• Double-blind, placebo-controlled study including 10,305 hypertensive patients treated with antihypertensive therapy and without a previous MI with TC ≤250 mg/dL (6.5 mmol/L)
• Patients also had ≥3 additional CV risk factors
• Randomized to LIPITOR^®10 mg (n=5168) or placebo (n=5137)
• Trial was terminated early (after a median follow-up of 3.3 years) on the recommendation of the data safety monitoring board, due to the significant early difference between groups in the primary endpoint
• Analysis includes the 2532 patients with diabetes randomized to LIPITOR^® (n=1258) or placebo (n=1274)

ASCOT-LLA: Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm; CHD: coronary heart disease; CV: cardiovascular;  MI: myocardial infarction; RRR: relative risk reduction; TC: total cholesterol.

LIPITOR^® Provides Significant CV Risk Reduction in Patients with Diabetes¹

Hypertension + Diabetes + ≥2 Additional Risk Factors

In an ASCOT-LLA post hoc subgroup analysis in patients with hypertension, diabetes, and ≥2 additional risk factors, LIPITOR^® 10 mg reduced the risk of total CV events and procedures by 23% compared with placebo²

Adapted from Sever PS et al. Diabetes Care. 2005.

ASCOT-LLA Study Design²

• Double-blind, placebo-controlled study including 10,305 hypertensive patients treated with antihypertensive therapy and without a previous MI with TC ≤250 mg/dL (6.5 mmol/L)
• Patients also had ≥3 additional CV risk factors
• Randomized to LIPITOR^® 10 mg (n=5168) or placebo (n=5137)
• Trial was terminated early (after a median follow-up of 3.3 years) on the recommendation of the data safety monitoring board, due to the significant early difference between groups in the primary endpoint.
• Analysis includes the 2532 patients with diabetes randomized to LIPITOR^® (n=1258) or placebo (n=1274)

Diabetes + ≥1 Additional Risk Factor

In the CARDS trial in patients with type 2 diabetes and ≥1 other CHD risk factor, LIPITOR^® 10 mg reduced the risk of major CV events by 37% compared with placebo¹

*Major CV events: MI (including silent MI), unstable angina, acute CHD death, resuscitated cardiac arrest, coronary revascularization, and stroke.⁴

• LIPITOR^®10 mg also reduced the risk of MI by 42% (P=0.007)³

In the CARDS trial in patients with type 2 diabetes and ≥1 risk factor, LIPITOR^® 10 mg reduced the risk of stroke by nearly half compared with placebo⁴

*Major CV events: MI (including silent MI), unstable angina, acute CHD death, resuscitated cardiac arrest, coronary revascularization, and stroke.⁴

• The lowest mean LDL-C level reached with LIPITOR^® in this study was 68 mg/dL (1.8 mmol/L)¹

CARDS Study Design^1,4,5

• Double-blind, prospective study in which 2838 patients aged 40 to 75 years were randomized to LIPITOR^® 10 mg (n=1428) or placebo (n=1410)
• Patients had type 2 diabetes, no documented history of CVD, LDL-C ≤160 mg/dL, TG ≤600 mg/dL, and ≥1 of the following: hypertension, retinopathy, albuminuria, or current smoking
• The primary endpoint was time to first occurrence of acute CHD events, coronary revascularization, or stroke
• Median duration of follow-up was 4.0 years (IQR 3.0-4.7) in the atorvastatin group; the CARDS trial was terminated at 3.9 years—2 years earlier than planned—due to highly significant benefits of atorvastatin

Diabetes + CKD,

In the CARDS post hoc subgroup analysis in high-risk patients with type 2 diabetes and CKD*, LIPITOR^® 10 mg significantly reduced the risk of stroke compared with placebo⁵

• In the CARDS post hoc subgroup analysis, LIPITOR^® 10 mg (n=482) reduced mean LDL-C from baseline 120 mg/dL to 71 mg/dL⁵

CARDS Study design^1,4,5

• Double-blind, prospective study in which 2838 patients aged 40 to 75 years were randomized to LIPITOR^® 10 mg (n=1428) or placebo (n=1410)
• Patients had type 2 diabetes, no documented history of CVD, LDL-C ≤160 mg/dL, TG ≤600 mg/dL, and ≥1 of the following: hypertension, retinopathy, albuminuria, or current smoking
• The primary endpoint was time to first occurrence of acute CHD events, coronary revascularization, or stroke
• Median duration of follow-up was 4.0 years (IQR 3.0-4.7) in the atorvastatin group; the CARDS trial was terminated at 3.9 years—2 years earlier than planned—due to highly significant benefits of atorvastatin

ASCOT-LLA: Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm; CARDS: Collaborative AtoRvastatin Diabetes Study; CHD: coronary heart disease; CV: cardiovascular; CVD: cardiovascular disease; CKD: chronic kidney disease; HDL-C: high-density lipoprotein cholesterol; IQR: interquartile range; LDL-C: low-density lipoprotein cholesterol; MI: myocardial infarction; RRR: relative risk reduction; TC: total cholesterol; TG: triglycerides.

Diabetes + ≥1 Additional Risk Factor
In the CARDS trial in patients with type 2 diabetes and ≥1 risk factor, LIPITOR^® 10 mg reduced the risk of stroke by nearly half compared with placebo¹

*Major CV events: MI (including silent MI), unstable angina, acute CHD death, resuscitated cardiac arrest, coronary revascularization, and stroke.¹

• The lowest mean LDL-C level reached with LIPITOR^® in this study was 68 mg/dL (1.8 mmol/L)²

CARDS Study Design^1,2

• Double-blind, prospective study in which 2838 patients aged 40 to 75 years were randomized to LIPITOR^® 10 mg (n=1428) or placebo (n=1410)
• Patients had type 2 diabetes, no documented history of CVD, LDL-C ≤160 mg/dL, TG ≤600 mg/dL, and ≥1 of the following: hypertension, retinopathy, albuminuria, or current smoking
• The primary endpoint was time to first occurrence of acute CHD events, coronary revascularization, or stroke
• Median duration of follow-up was 4.0 years (IQR 3.0-4.7) in the atorvastatin group; the CARDS trial was terminated at 3.9 years—2 years earlier than planned—due to highly significant benefits of atorvastatin

Diabetes + CKD

In the CARDS post hoc subgroup analysis in high-risk patients with type 2 diabetes and CKD, LIPITOR® 10 mg significantly reduced the risk of stroke compared with placebo⁵

• In the CARDS post hoc subgroup analysis, LIPITOR^® 10 mg (n=482) reduced mean LDL-C from baseline 120 mg/dL to 71 mg/dL³

CARDS study design^1-3

• Double-blind, prospective study in which 2838 patients aged 40 to 75 years were randomized to LIPITOR^® 10 mg (n=1428) or placebo (n=1410)
• Patients had type 2 diabetes, no documented history of CVD, LDL-C ≤160 mg/dL, TG =600 mg/dL, and ≥1 of the following: hypertension, retinopathy, albuminuria, or current smoking
• The primary endpoint was time to first occurrence of acute CHD events, coronary revascularization, or stroke
• Median duration of follow-up was 4.0 years (IQR 3.0-4.7) in the atorvastatin group; the CARDS trial was terminated at 3.9 years—2 years earlier than planned—due to highly significant benefits of atorvastatin

Hypertension + ≥3 Additional Risk Factors

In the ASCOT-LLA trial in patients with hypertension and ≥3 additional risk factors, LIPITOR^® 10 mg reduced the risk of fatal and nonfatal stroke by 27% compared with placebo⁴

ASCOT-LLA study design⁴

• Double-blind, placebo-controlled study including 10,305 hypertensive patients treated with antihypertensive therapy and without a previous MI with TC ≤250 mg/dL (6.5 mmol/L)
• Patients also had ≥3 additional CV risk factors
• Randomized to LIPITOR^® 10 mg (n=5168) or placebo (n=5137)
• Trial was terminated early (after a median follow-up of 3.3 years) on the recommendation of the data safety monitoring board, due to the significant early difference between groups in the primary endpoint
• Analysis includes the 2532 patients with diabetes randomized to LIPITOR^® (n=1258) or placebo (n=1274)

ASCOT-LLA: Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm; CARDS:Collaborative Atorvastatin Diabetes Study; CHD: coronary heart disease; CV: cardiovascular; CVD: cardiovascular disease; CKD: chronic kidney disease; HDL-C: high-density lipoprotein cholesterol; IQR: interquartile range; LDL-C: low-density lipoprotein cholesterol; MI: myocardial infarction; RRR: relative risk reduction; TC: total cholesterol; TG: triglycerides.

Diabetes
LIPITOR^® Provides Significant CV Risk Reduction in Patients with Diabetes¹

Farah*

Age: 61 years old
Occupation: Seamstress
Family status: Married, 4 children.
Overweight: BMI 29.7

Hypertension for 11 years

• Treated with amlodipine 5 mg.
• Current BP: 125/80 mm Hg

Type 2 diabetes for 10 years

• Fasting plasma glucose: 119 mg/dL
• HbA1c: 6.8%
• Taking metformin 500 mg BID

Menopausal

Lipid profile

• TC: 237 mg/dL (6.1 mmol/L)
• LDL-C: 132 mg/dL (3.4 mmol/L)
• TG: 240 mg/dL (2.7 mmol/L)
• HDL-C: 38 mg/dL (1.0 mmol/L)

  10-year ACC/AHA ASCVD Risk

• 12.5% calculated risk

Recent guidelines recommend moderate-† to-high-intensity‡ statin therapy to reduce CV risk in patients with diabetes^2-5

*This patient case study is fictional. Medical profile data have been derived for illustrative purposes only.

^†Moderate-intensity statin is defined as statin therapy that results in approximately 30% to <50% LDL-C reduction.^2,3

^‡High-intensity statin is defined as statin therapy that results in ≥50% LDL-C reduction^.2,3

Hypertension
LIPITOR^® Provides Proven Outcomes for High-Risk Patients with Primary Hypertension⁶

Addullah*

Age: 55 years old
Occupation: Vendor
Family status: Widowed
Overweight: BMI 25.3

Hypertension for 23 years

• Mean SBP=151 mm Hg
• Taking amlodipine 5 mg QD

Lipid Profile

• TC: 220 mg/dL (5.7 mmol/L)
• LDL-C: 147 mg/dL (3.8 mmol/L)
• TG: 160 mg/dL (1.81 mmol/L)
• HDL-C: 35 mg/dL (0.91 mmol/L)

10-Year ACC/AHA ASCVD Risk

• 11.2% calculated risk

Guidelines recommend statin therapy for the primary prevention of CVD^4,5,7

*This patient case study is fictional. Medical profile data have been derived for illustrative purposes only.

Hypertension and Multiple Risk Factors
LIPITOR^® Provides Significant CV Risk Reduction in Patients with Hypertension and Multiple Risk Factors⁶

Maria*

Age: 54 years old
Occupation: Florist
Family status: Married,3 children
Overweight: BMI 29.8

Hypertension for 3 years

• Treated with 5mg amlodipine per day
• Current BP: 135/80 mm Hg

Smoker

• 10 packs/week for 10 years

Menopausal

Lipid profile

• TC: 246 mg/dL (6.4 mmol/L)
• LDL-C: 155 mg/dL (4.0 mmol/L)
• TG: 225 mg/dL (2.5 mmol/L)
• HDL-C: 46 mg/dL (1.2 mmol/L)

10-Year ACC/AHA ASCVD Risk

• 10.0% calculated risk

Guidelines recommend moderate-^† to-high- intensity^‡ statin therapy in patients with hypertension and multiple CV risk factors.^3-5,7

*This patient case study is fictional. Medical profile data have been derived for illustrative purposes only.
^†Moderate-intensity statin is defined as statin therapy that results in approximately 30% to <50% LDL-C reduction.^3
‡High-intensity statin is defined as statin therapy that results in ≥50% LDL-C reduction.³

 

 

ACC: American College of Cardiology; ADA: American Diabetes Association; AHA: American Heart Association; ASCVD; atherosclerotic cardiovascular disease; BID: twice daily; BP: blood pressure; CV: cardiovascular; CVD: cardiovascular disease; ESC: European Society of Cardiology; ESH: European Society of Hypertension; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol; NICE: National Institute for Health and Care Excellence; QD: once daily; SBP: systolic blood pressure; TC: total cholesterol; TG: triglycerides.

These highlights do not include all the information needed to use LIPITOR^® safely and effectively. See full Prescribing Information for LIPITOR^®.

Dosing
LIPITOR^® Dosing Guide¹

LIPITOR^® is available in 10, 20, 40, and 80 mg tablets.¹

 

LIPITOR^® may be used with bile acid resins.¹
The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution.¹
Dosage adjustment in patients with renal dysfunction is not necessary.¹

See full Prescribing Information for LIPITOR.

Contraindications

Contraindications¹

• Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels exceeding three times the upper limit of normal.
• Women who are pregnant or may become pregnant.
• Nursing mothers
• Hypersensitivity to any component of this medication

Warnings + Precautions

Warnings + Precautions¹

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician any unexplained and/or persistent muscle pain, tenderness, or weakness. LIPITOR^® therapy should be discontinued if myopathy is diagnosed or suspected.¹
Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.¹
A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the 6 months before therapy in the LIPITOR^® 80 mg group versus placebo.¹

Undesirable Effects

Undesirable Effects¹
The common undesirable effects are nasopharyngitis allergic reaction, hyperglycemia, headache, pharyngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhea, myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain, liver function test abnormal, blood creatine kinase increased.¹

To learn more about how to report SUSPECTED ADVERSE REACTIONS, please review the Report Adverse Events page

Drug Interactions

Drug Interactions¹

To learn more about how to report SUSPECTED ADVERSE REACTIONS, please review the Report Adverse Events page

 

• Other Lipid-Lowering Medications: Use of LIPITOR^® with fibrate products or lipid-modifying doses of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with LIPITOR^®.¹
• Digoxin: Patients should be monitored appropriately.¹
• Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased.¹
• Rifampin should be simultaneously co-administered with LIPITOR^®.¹

Lipitor^® (Atorvastatin) Abbreviated Prescribing Information.

Presentation: Lipitor supplied as white, elliptical film-coated tablet containing 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin as excipient atorvastatin calcium trihydrate in blister packs of 30 and/or 100 film-coated tablets. Indications: Hypercholesterolaemia: Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Lipitor is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease: Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event as an adjunct to correction of other risk factors. Dosage and Administration: Posology: Patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue this diet during treatment with Lipitor. Usual starting dose is 10 mg once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. Lipitor is for oral administration. Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food. Prevention of cardiovascular disease: In the primary prevention trials the dose was 10 mg/day. Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines. Renal impairment: No adjustment of dose is required. Hepatic impairment: Should be used with caution in patients with hepatic impairment. Lipitor is contraindicated in patients with active liver disease. Elderly: Efficacy and safety in patients older than 70 using recommended doses are like those seen in the general population. Paediatric population: Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress. For patients with Heterozygous Familial Hypercholesterolemia aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day. The dose may be increased to 80 mg daily, according to the response and tolerability. Adjustments should be made at intervals of 4 weeks or more. Atorvastatin is not indicated in the treatment of patients below the age of 10 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients, active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal, during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures, and treated with the hepatitis C antivirals glecaprevir/pibrentasvir. Special warnings and precautions: Liver effects: LFT should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction of dose or withdrawal of Lipitor is recommended. Lipitor should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL): In a post-hoc analysis of stroke subtypes in patients without coronary heart disease (CHD) who had a recent stroke or transient ischemic attack (TIA) there was a higher incidence of haemorrhagic stroke in patients initiated on atorvastatin 80 mg compared to placebo. The increased risk was particularly noted in patients with prior haemorrhagic stroke or lacunar infarct at study entry. Skeletal muscle effects: Atorvastatin may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, myoglobinaemia and myoglobinuria which may lead to renal failure. Interactions: Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins (e.g., ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, Posaconazole, letermovir and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, or the combination of tipranavir/ritonavir, etc.). The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, erythromycin, niacin or ezetimibe; also, with the concomitant use of other antivirals for the treatment of hepatitis C (HCV) like (boceprevir, telaprevir, elbasvir/grazoprevir, ledipasvir/sofosbuvir). In cases where co-administration of these medicinal products with atorvastatin cannot be avoided, when patients are receiving medicinal products that increase the plasma concentration of atorvastatin, a lower maximum dose of atorvastatin is recommended. In the case of potent CYP3A4 inhibitors, a lower starting dose of atorvastatin should be considered and appropriate clinical monitoring of these patients is recommended. Fertility, Pregnancy and lactation: Women of childbearing potential: Women of child-bearing potential should use appropriate contraceptive measures during treatment. Pregnancy: Lipitor is contraindicated during pregnancy. Breast-feeding: It is unknown whether atorvastatin or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions, women taking Lipitor should not breast-feed their infants Atorvastatin is contraindicated during breast-feeding. Fertility: In animal studies atorvastatin had no effect on male or female fertility. Effects on ability to drive and use machines: Lipitor has negligible influence on the ability to drive and use machines. Undesirable effects: In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo. The common undesirable effects are nasopharyngitis, allergic reaction, hyperglycaemia, headache, pharyngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhoea, myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain, liver function test abnormal and blood creatine kinase increased. Overdose: Specific treatment is not available for Lipitor overdose. Patient should be treated symptomatically, and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance. Pharmaceutical precautions: Keep in a dry place. Store below 30 °C. Do not use Lipitor after the expiry date which is stated on the carton after EXP: The expiry date refers to the last day of that month. Keep out of the sight and reach of children.
Reference: Lipitor SmPC Gulf States,: Revision dated October 2020 for UAE (Registered Lipitor 10mg,20mg,40mg & 80mg), Jordan (Registered Lipitor 10mg, 20mg, 40mg & 80mg), Iraq (Registered Lipitor 20mg ); Revision dated June 2021 for Kuwait (Registered Lipitor 10mg, 20mg, 40mg & 80mg), Qatar (Registered Lipitor 10mg, 20mg, 40mg & 80mg), Bahrain (Registered Lipitor 10mg, 20mg, 40mg & 80mg), Oman (Registered Lipitor 10mg, 20mg & 40mg), and Iraq (Registered Lipitor 10mg, 40mg & 80mg).

Date of Document:18th of January 2023

Full prescribing information is available upon request