CV Outcomes Data

LIPITOR has proven CV outcomes evidence from multiple landmark trials

There are factors to consider when choosing which statin is right for your patients. LIPITOR provides mean LDL-C reductions of 39%-60% across the approved dose range and has CV outcomes indications for high-risk patients with CHD or type 2 diabetes and ≥1 risk factor.

The clinical experience of LIPITOR includes CV outcomes evidence in a broad range of higher-risk patients as highlighted below.

Click on the + icon to access more information below.

	Patient population	Main trial (subgroup)
	CHD	TNT
In the TNT trial (N=10,001) in patients with CHD, LIPITOR 80 mg* provided a 22% RRR in the primary end point of major CV events^† compared with LIPITOR 10 mg (P<.001).¹ The risk of stroke, a component of the primary end point, was reduced by a quarter¹: *LIPITOR 80 mg is not a starting dose. ^†In TNT, major CV events were defined as time to first occurrence of death from CHD, nonfatal non-procedure-related MI, resuscitation after cardiac arrest, or fatal or nonfatal stroke.¹ Click here for study description
	CHD and type 2 diabetes	TNT (diabetes)
In the overall TNT trial (N=10,001) in patients with CHD, LIPITOR 80 mg* provided a 22% RRR in the primary end point of major CV events^† compared with LIPITOR 10 mg (P<.001).¹ A post hoc subgroup analysis (n=1501) of the TNT trial in patients with CHD and type 2 diabetes revealed²: *LIPITOR 80 mg is not a starting dose. ^†In TNT and a TNT-Diabetes post hoc subgroup analysis, major CV events were defined as time to first occurrence of death from CHD, nonfatal non-procedure-related MI, resuscitation after cardiac arrest, or fatal or nonfatal stroke.^1,2 Click here for study description
	CHD and prior CHF	TNT (CHF)
In the overall TNT trial (N=10,001) in patients with CHD, LIPITOR 80 mg* provided a 22% RRR in the primary end point of major CV events^† compared with LIPITOR 10 mg (P<.001).¹ Additionally, in the overall study population (patients with CHD, both with and without CHF), LIPITOR 80 mg* provided a 26% RRR in the prespecified end point of hospitalization for CHF compared with LIPITOR 10 mg (P=.01).¹ A post hoc subgroup analysis (n=781) of the TNT trial in patients with CHD and prior CHF revealed³: *LIPITOR 80 mg is not a starting dose. ^†In TNT, major CV events were defined as time to first occurrence of death from CHD, nonfatal non-procedure-related MI, resuscitation after cardiac arrest, or fatal or nonfatal stroke.¹ Click here for study description
	CHD and age ≥65	TNT (≥65)
In the overall TNT trial (N=10,001) in patients with CHD, LIPITOR 80 mg* provided a 22% RRR in the primary end point of major CV events^† compared with LIPITOR 10 mg (P<.001).¹ A prespecified secondary subgroup analysis (n=3809) of the TNT trial in patients with CHD and age ≥65 years revealed⁴: Rare cases of rhabdomyolysis have been reported with LIPITOR and other statins. Predisposing factors include advanced age (≥65). Therefore, LIPITOR should be prescribed with caution in patients >65 years. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued. *LIPITOR 80 mg is not a starting dose. ^†In TNT and a TNT-Aged ≥65 prespecified secondary subgroup analysis, major CV events were defined as time to first occurrence of death from CHD, nonfatal non-procedure-related MI, resuscitation after cardiac arrest, or fatal or nonfatal stroke.^1,4 Click here for study description
	CHD and prior CABG	TNT (CABG)
In the overall TNT trial (N=10,001) in patients with CHD, LIPITOR 80 mg* provided a 22% RRR in the primary end point of major CV events^† compared with LIPITOR 10 mg (P<.001).¹ A post hoc subgroup analysis (n=4654) of the TNT trial in patients with CHD and prior CABG revealed⁵: *LIPITOR 80 mg is not a starting dose. ^†In TNT and a TNT-CABG post hoc subgroup analysis, major CV events were defined as time to first occurrence of death from CHD, nonfatal non-procedure-related MI, resuscitation after cardiac arrest, or fatal or nonfatal stroke.^1,5 Click here for study description
	CHD and CKD (eGFR <60 mL/min/1.73 m²)	TNT (CKD)
In the overall TNT trial (N=10,001) in patients with CHD, LIPITOR 80 mg* provided a 22% RRR in the primary end point of major CV events^† compared with LIPITOR 10 mg (P<.001).¹ A post hoc subgroup analysis (n=3107) of the TNT trial in patients with CHD and CKD (eGFR <60 mL/min/1.73 m²) revealed⁶: LIPITOR is not indicated for the treatment of CKD. Rare cases of rhabdomyolysis have been reported with LIPITOR and with other drugs in this class. Renal impairment may be a risk factor for the development of rhabdomyolysis. Therefore, such patients merit closer monitoring. *LIPITOR 80 mg is not a starting dose. ^†In TNT and a TNT-CKD post hoc subgroup analysis, major CV events were defined as time to first occurrence of death from CHD, nonfatal non-procedure-related MI, resuscitation after cardiac arrest, or fatal or nonfatal stroke.^1,6 Click here for study description
	CHD	ALLIANCE
In the ALLIANCE trial (N=2442) in patients with CHD, a mean LIPITOR 40.5 mg dose provided a 17% RRR in the primary end point of primary CV events‡ compared with usual care (P=.026).⁷ Risk of nonfatal MI, a component of the primary end point, was reduced by nearly half^7,8: ^‡In ALLIANCE, primary CV events were defined as time to first occurrence of cardiac death, nonfatal MI, resuscitated cardiac arrest, cardiac revascularization, and unstable angina requiring hospitalization.⁷ ^§Usual care was defined as any treatment such as diet, behavior modification, or other lipid- lowering therapy—which may have included LIPITOR after approval in 1997—deemed appropriate by patients' physicians. Patients in the LIPITOR arm started at the 10-mg dose, and the dosage was doubled every 4 weeks until an LDL-C level of <80 mg/dL or a maximum LIPITOR dose of 80 mg was achieved. The mean LDL-C levels at baseline (on pre-randomization lipid-lowering treatment) were 147 mg/dL in the LIPITOR group and 146 mg/dL in the usual care group. At study end, LDL-C levels were significantly decreased to 95 mg/dL with LIPITOR and 111 mg/dL with usual care (P<.0001).^7,8 Click here for study description
	Type 2 diabetes and ≥1 risk factor	CARDS
In the CARDS trial (N=2838) in patients with type 2 diabetes and ≥1 risk factor, LIPITOR 10 mg provided a 37% RRR in the primary end point of major CV events^\|\| compared with placebo (P=.001).⁹ Risk of stroke, a component of the primary end point, was reduced by nearly half¹⁰: ^\|\|In CARDS, major CV events were defined as time to first occurrence of MI, acute CHD death, unstable angina, resuscitated cardiac arrest, coronary revascularization, or stroke.⁹ Click here for study description
	Type 2 diabetes and ≥1 risk factor and age ≥65	CARDS (≥65)
In the overall CARDS trial (N=2838) in patients with type 2 diabetes and ≥1 risk factor, LIPITOR 10 mg provided a 37% RRR in the primary end point of major CV events^\|\| compared with placebo (P=.001).⁹ A post hoc subgroup analysis (n=1129) of the CARDS trial in patients with type 2 diabetes and ≥1 risk factor and age ≥65 years revealed¹¹: Rare cases of rhabomyolysis have been reported with LIPITOR and other statins. Predisposing factors include advanced age (≥65). Therefore, LIPITOR should be prescribed with caution in patients >65 years. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued. ^\|\|In CARDS and a CARDS-Aged ≥65 post hoc subgroup analysis, major CV events were defined as time to first occurrence of MI, acute CHD death, unstable angina, resuscitated cardiac arrest, coronary revascularization, or stroke.^9,11 Click here for study description
	Type 2 diabetes and CKD (eGFR <60 mL/min/1.73 m²)	CARDS (CKD)
In the overall CARDS trial (N=2838) in patients with type 2 diabetes and ≥1 risk factor, LIPITOR 10 mg provided a 37% RRR in the primary end point of major CV events^\|\| compared with placebo (P=.001).⁹ A post hoc subgroup analysis (n=970) of the CARDS trial in patients with type 2 diabetes and ≥1 risk factor and CKD (eGFR <60 mL/min/1.73 m²) revealed a 42% RRR in the primary end point of major CV events^\|\| with LIPITOR 10 mg compared with placebo (P=.03), as well as¹²: LIPITOR is not indicated for the treatment of CKD. Rare cases of rhabdomyolysis have been reported with LIPITOR and with other drugs in this class. Renal impairment may be a risk factor for the development of rhabdomyolysis. Therefore, such patients merit closer monitoring. ^\|\|In CARDS and a CARDS-CKD post hoc subgroup analysis, major CV events were defined as time to first occurrence of MI, acute CHD death, unstable angina, resuscitated cardiac arrest, coronary revascularization, or stroke.^9,12 Click here for study description
	Multiple risk factors	ASCOT-LLA
In the ASCOT-LLA trial (N=10,305) in patients without CHD but with ≥3 risk factors for heart disease, LIPITOR 10 mg provided a 36% RRR in the primary end point of nonfatal MI and fatal CHD^¶ (P=.0005).¹³ Risk of nonfatal MI, a component of the primary end point, was reduced by nearly half⁸: ^¶Fatal CHD component of the primary end point did not achieve statistical significance. Click here for study description

Proven CV outcomes evidence

Unlike Crestor^®, LIPITOR is FDA-approved to reduce the risk of MI and stroke in high-risk patients with CHD or type 2 diabetes and ≥1 risk factor.

LIPITOR is supported by a wealth of clinical experience. In fact, LIPITOR has been studied in more than 400 clinical trials including more than 80,000 patients.⁸ LIPITOR also has a well-established safety profile which includes high-risk patients with CHD or type 2 diabetes and ≥1 risk factor. To learn more about the safety profile of LIPITOR, click here.

To access a library of clinical study abstracts and reprints, click here

^*LIPITOR 80 mg is not a starting dose.

^†In TNT, major CV events were defined as time to first occurrence of death from CHD, nonfatal non-procedure-
related MI, resuscitation after cardiac arrest, or fatal or nonfatal stroke.

^‡In ALLIANCE, primary CV events were defined as time to first occurrence of cardiac death, nonfatal MI,
resuscitated cardiac arrest, cardiac revascularization, and unstable angina requiring hospitalization.

^§Usual care was defined as any treatment such as diet, behavior modification, or other lipid-lowering therapy
  —which may have included LIPITOR after approval in 1997—deemed appropriate by patients' physicians.
  Patients in the LIPITOR arm started at the 10-mg dose, and the dosage was doubled every 4 weeks until an
  LDL-C level of <80 mg/dL or a maximum LIPITOR dose of 80 mg was achieved. The mean LDL-C levels at baseline   (on pre-randomization lipid-lowering treatment) were 147 mg/dL in the LIPITOR group and 146 mg/dL in the usual   care group. At study end, LDL-C levels were significantly decreased to 95 mg/dL with LIPITOR and 111 mg/dL
  with usual care (P<.0001).^7,8

^||In CARDS, major CV events were defined as time to first occurrence of MI, acute CHD death, unstable angina,
resuscitated cardiac arrest, coronary revascularization, or stroke.

^¶Fatal CHD component of the primary end point did not achieve statistical significance.

^#Properly randomized trials were included in this overview if they met the following criteria: the trial evaluated CV
   outcomes; at least 1 of the trial interventions was to modify lipid levels with statin treatment; the trial was
   unconfounded with respect to this intervention (ie, no other differences in risk factor modification between the
   treatment groups were intended); and the trial aimed to recruit >1000 subjects.

^**Trials include ASCOT-LLA,¹³ CARDS,⁹ IDEAL,¹⁹ PROVE IT (a study sponsored by Bristol-Myers Squibb and
Sankyo),¹⁶ SPARCL,²⁰ TNT,¹ and JUPITER.²¹

RRR=relative risk reduction.

Crestor (rosuvastatin calcium) is a registered trademark of the AstraZeneca group of companies.

LIPITOR Important Safety Information and Indications

Please scroll to see the Indications below.

Important Safety Information

LIPITOR is contraindicated in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are nursing; in patients with hypersensitivity to any component of this medication.

Rare cases of rhabdomyolysis have been reported with LIPITOR and other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.

The concomitant use of higher doses of LIPITOR with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Lower doses of LIPITOR should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.

It is recommended that liver function tests be performed prior to and 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. If ALT or AST values >3 x ULN persist, dose reduction or withdrawal is recommended.

In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the LIPITOR 80-mg group compared with placebo (2.3% vs 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the LIPITOR group.

The most commonly reported adverse reactions with LIPITOR in placebo-controlled trials were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

Indications

LIPITOR is indicated as an adjunct to diet to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and stroke in patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adult patients with clinically evident CHD.

LIPITOR, as an adjunct to diet, is also indicated to reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

^††LIPITOR $4 Co-Pay Card Terms & Conditions

By using the LIPITOR $4 Co-Pay Card (the "Card"), you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

This Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma de Salud"]). The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs. To qualify for this offer, your out-of-pocket expense must be greater than $4 per prescription. If your out-of-pocket expenses for a 1-month supply (30 tablets) are $54 or less, you will pay $4 for a 1-month supply. If your out-of-pocket expenses for a 1-month supply (30 tablets) exceed $54, you qualify for up to $50 in savings for a 1-month supply. In either case, you can only qualify for up to $600 of savings per calendar year. After a maximum of $600, you will pay usual monthly out-of-pocket costs. You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf. The Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law. This Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. The Card will be accepted only at participating pharmacies. This Card is not health insurance. Offer good only in the US and Puerto Rico. The Card is limited to 1 per person during this offering period and is not transferable. Offer limited to 1 use per month. Pfizer reserves the right to rescind, revoke or amend the program without notice at any time. Card and Program expire 12/31/2012. No membership fees.

For reimbursement when using a non-participating pharmacy/mail order: Pay for LIPITOR prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: LIPITOR Co-Pay Card, 6501 Weston Parkway, Suite 370, Cary, NC 27513. Be sure to include a copy of the front of your Co-Pay Card, your name, and mailing address.

For healthcare professional customer service, call 1-800-505-4426 Monday through Friday, 8:30 AM to 5:30 PM EST or visit www.LipitorHCP.com. Pfizer Inc., 235 East 42nd Street, New York, NY 10017.

Please see full prescribing and patient information

References: 1. LaRosa JC, Grundy SM, Waters DD, et al; for Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med.2005;352(14):1425-1435. 2. Shepherd J, Barter P, Carmena R, et al; for Treating to New Targets Investigators. Effect of lowering LDL cholesterol substantially below currently recommended levels in patients with coronary heart disease and diabetes: the Treating to New Targets (TNT) study. Diabetes Care. 2006;29(6):1220-1226. 3. Khush KK, Waters DD, Bittner V, et al. Effect of high-dose atorvastatin on hospitalizations for heart failure: subgroup analysis of the Treating to New Targets (TNT) study. Circulation. 2007;115(5):576-583. 4. Wenger NK, Lewis SJ, Herrington DM, Bittner V, Welty FK; for Treating to New Targets Study Steering Committee and Investigators. Outcomes of using high- or low-dose atorvastatin in patients 65 years of age or older with stable coronary disease. Ann Intern Med. 2007;147(1);1-9. 5. Shah SJ, Waters DD, Barter P, et al. Intensive lipid-lowering with atorvastatin for secondary prevention in patients after coronary artery bypass surgery. J Am Coll Cardiol. 2008;51(20):1938-1943. 6. Shepherd J, Kastelein JJP, Bittner V, et al; for Treating to New Targets Investigators. Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol. 2008;51(15):1448-1454. 7. Koren MJ, Hunninghake DB; for ALLIANCE Investigators. Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the ALLIANCE study. J Am Coll Cardiol. 2004;44(9):1772-1779. 8. Data on file. Pfizer Inc, New York, NY. 9. Colhoun HM, Betteridge DJ, Durrington PN, et al; for CARDS Investigators. 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. 10. Hitman GA, Colhoun H, Newman C, et al; for CARDS Investigators. Stroke prediction and stroke prevention with atorvastatin in the Collaborative Atorvastatin Diabetes Study (CARDS). Diabet Med. 2007;24(12):1313-1321. 11. Neil HAW, DeMicco DA, Luo D, et al; for CARDS Study Investigators. Analysis of efficacy and safety in patients aged 65-75 years at randomization: Collaborative Atorvastatin Diabetes Study (CARDS). Diabetes Care. 2006;29(11):2378-2384. 12. Colhoun HM, Betteridge DJ, Durrington PN, et al; for CARDS Investigators. 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. doi:10.1053/j.ajkd.2009.03.022. 13. Sever PS, Dahlöf B, Poulter NR, et al; for ASCOT Investigators. 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. 14. Athyros VG, Papageorgiou AA, Mercouris BR, et al. Treatment with atorvastatin to the National Cholesterol Educational Program goal versus 'usual' care in secondary coronary heart disease prevention: the GREek Atorvastatin and Coronary-heart-disease Evaluation (GREACE) study. Curr Med Res Opin. 2002;18(4):220-228. 15. Schwartz GG, Olsson AG, Ezekowitz MD, et al; for 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. 2001;285(13):1711-1718. 16. Cannon CP, Braunwald E, McCabe CH, et al; for Pravastatin or Atorvastatin Evaluation and Infection Therapy—Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350(15):1495-1504. 17. Wanner C, Krane V, März W, et al; for German Diabetes and Dialysis Study Investigators. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med. 2005;353(3):238-248. 18. Knopp RH, d'Emden M, Smilde JG, Pocock SJ; for ASPEN Study Group. Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-insulin-dependent Diabetes Mellitus (ASPEN). Diabetes Care. 2006;29(7):1478-1485. 19. Pedersen TR, Faergeman O, Kastelein JJP, et al; for Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA. 2005;294(19):2437- 2445. 20. Amarenco P, Bogousslavsky J, Callahan A III, et al; for Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006;355(6):549-559. 21. Ridker PM, Danielson E, Fonseca FAH, et al; for JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359(21):2195-2207. 22. Kjekshus J, Apetrei E, Barrios V, et al; for CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007;357(22):2248-2261. 23. GISSI-HF Investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372(9645):1231-1239. 24. Fellström BC, Jardine AG, Schmieder RE, et al; for AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009;360(14):1395-1407. 25. Grundy SM, Cleeman JI, Bairey Merz CN, et al; for Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110(2):227-239. 26. Smith SC Jr, Allen J, Blair SN, et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol. 2006;47(10):2130-2139. 27. American Diabetes Association. Standards of medical care in diabetes—2010. Diabetes Care. 2010;33(suppl 1):S11-S61. 28. Adams RJ, Albers G, Alberts MJ, et al. Update to the AHA/ASA recommendations for the prevention of stroke in patients with stroke and transient ischemic attack. Stroke. 2008;39(5):1647-1652. 29. KDOQI. KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and chronic kidney disease. Am J Kidney Dis. 2007;49(2)(suppl 2):S1-S179. 30. Mosca L, Benjamin EJ, Berra K, et al. Effectiveness-based guidelines for the prevention of cardiovascular disease in women—2011 update: a guideline from the American Heart Association [published online ahead of print February 14, 2011]. Circulation. doi:10.1161/CIR.0b013e31820faaf8.

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LIPITOR has proven CV outcomes evidence from multiple landmark trials

Patient population

Main trial (subgroup)

CHD

TNT

The risk of stroke, a component of the primary end point, was reduced by a quarter1:

CHD and type 2 diabetes

TNT (diabetes)

A post hoc subgroup analysis (n=1501) of the TNT trial in patients with CHD and type 2 diabetes revealed2:

CHD and prior CHF

TNT (CHF)

A post hoc subgroup analysis (n=781) of the TNT trial in patients with CHD and prior CHF revealed3:

CHD and age ≥65

TNT (≥65)

A prespecified secondary subgroup analysis (n=3809) of the TNT trial in patients with CHD and age ≥65 years revealed4:

CHD and prior CABG

TNT (CABG)

A post hoc subgroup analysis (n=4654) of the TNT trial in patients with CHD and prior CABG revealed5:

CHD and CKD (eGFR <60 mL/min/1.73 m2)

TNT (CKD)

A post hoc subgroup analysis (n=3107) of the TNT trial in patients with CHD and CKD (eGFR <60 mL/min/1.73 m2) revealed6:

CHD

ALLIANCE

Risk of nonfatal MI, a component of the primary end point, was reduced by nearly half7,8:

Type 2 diabetes and ≥1 risk factor

CARDS

Risk of stroke, a component of the primary end point, was reduced by nearly half10:

Type 2 diabetes and ≥1 risk factor and age ≥65

CARDS (≥65)

A post hoc subgroup analysis (n=1129) of the CARDS trial in patients with type 2 diabetes and ≥1 risk factor and age ≥65 years revealed11:

Type 2 diabetes and CKD (eGFR <60 mL/min/1.73 m2)

CARDS (CKD)

A post hoc subgroup analysis (n=970) of the CARDS trial in patients with type 2 diabetes and ≥1 risk factor and CKD (eGFR <60 mL/min/1.73 m2) revealed a 42% RRR in the primary end point of major CV events|| with LIPITOR 10 mg compared with placebo (P=.03), as well as12:

Multiple risk factors

ASCOT-LLA

Risk of nonfatal MI, a component of the primary end point, was reduced by nearly half8:

Proven CV outcomes evidence

To access a library of clinical study abstracts and reprints, click here

LIPITOR Important Safety Information and Indications

Important Safety Information

Indications

The risk of stroke, a component of the primary end point, was reduced by a quarter¹:

A post hoc subgroup analysis (n=1501) of the TNT trial in patients with CHD and type 2 diabetes revealed²:

A post hoc subgroup analysis (n=781) of the TNT trial in patients with CHD and prior CHF revealed³:

A prespecified secondary subgroup analysis (n=3809) of the TNT trial in patients with CHD and age ≥65 years revealed⁴:

A post hoc subgroup analysis (n=4654) of the TNT trial in patients with CHD and prior CABG revealed⁵:

CHD and CKD (eGFR <60 mL/min/1.73 m²)

A post hoc subgroup analysis (n=3107) of the TNT trial in patients with CHD and CKD (eGFR <60 mL/min/1.73 m²) revealed⁶:

Risk of nonfatal MI, a component of the primary end point, was reduced by nearly half^7,8:

Risk of stroke, a component of the primary end point, was reduced by nearly half¹⁰:

A post hoc subgroup analysis (n=1129) of the CARDS trial in patients with type 2 diabetes and ≥1 risk factor and age ≥65 years revealed¹¹:

Type 2 diabetes and CKD (eGFR <60 mL/min/1.73 m²)

A post hoc subgroup analysis (n=970) of the CARDS trial in patients with type 2 diabetes and ≥1 risk factor and CKD (eGFR <60 mL/min/1.73 m²) revealed a 42% RRR in the primary end point of major CV events^|| with LIPITOR 10 mg compared with placebo (P=.03), as well as¹²:

Risk of nonfatal MI, a component of the primary end point, was reduced by nearly half⁸: