CRESTOR Launch Presentation January 2011

CRESTORCRESTOR®®

(Rosuvastatin)(Rosuvastatin)

ContentsContents

Improving Lipid Management CRESTOR®

– Efficacy– Safety and Tolerability– Clinical Pharmacology

CRESTOR® Dosing and Administration GALAXY Programme TM

Lipid ManagementLipid Management

Lipid ManagementLipid Management

Cholesterol management remains suboptimal– Insufficient doses– Limited drug effectiveness– Poor patient compliance

Options for improving lipid management– Dose titration– Combination therapy– More efficacious statin

Meta-analysis of 38 primary and secondary prevention trials, with more than 98,000 patients in total

Mortality in CHD, p=0.012

Total mortality, p=0.04

Benefit of Lowering CholesterolBenefit of Lowering Cholesterol

Adapted from Gould AL et al. Circulation 1998;97:946–952

Cholesterol reduction (%)

Mor

talit

y (l

og o

dds

rati

o)

0 4 8 12 16 20 24 28 32–1.0

–0.8

–0.6

–0.4

–0.2

0.0

LDL-C achieved mg/dL (mmol/L)

WOSCOPS – PlaceboAFCAPS - Placebo

ASCOT - PlaceboAFCAPS - Rx WOSCOPS - Rx

ASCOT - Rx

4S - Rx

HPS - Placebo

LIPID - Rx

4S - Placebo

CARE - Rx

LIPID - PlaceboCARE - Placebo

HPS - Rx

0

5

10

15

20

25

30

40(1.0)

60(1.6)

80(2.1)

100(2.6)

120(3.1)

140(3.6)

160(4.1)

180(4.7)

Even

t ra

te (

%)

6

Secondary Prevention

Primary Prevention

Rx - Statin therapyPRA – pravastatinATV - atorvastatin

200(5.2)

PROVE-IT - PRAPROVE-IT – ATV

Adapted from Rosensen RS. Exp Opin Emerg Drugs 2004;9(2):269-279LaRosa JC et al. N Engl J Med 2005;352:1425-1435

TNT – ATV10TNT – ATV80

On-Treatment LDL-C is Closely Related to CHD On-Treatment LDL-C is Closely Related to CHD Events in Statin Trials – Events in Statin Trials – Lower is BetterLower is Better

Cannon C et al. N Engl J Med 2004;350:1495-1504LaRosa JC et al. N Engl J Med 2005;352:1425-1435

0 3 18 21 24 27 306 9 12 15Months of follow-up

pravastatin 40 mgMedian LDL-C reduction 10%

LDL-C achieved 95 mg/dL Event rate 26.3%

atorvastatin 80 mgMedian LDL-C reduction 42%

LDL-C achieved 62 mg/dL Event rate 22.4%

16% RR (p=0.005)

30

25

20

15

10

5

0All-c

ause

dea

th o

r m

ajor

CV

eve

nts

(%)

0 3 4 5 61 2Years

atorvastatin 10 mgMean LDL-C 101 mg/dL

Event rate 10.9%

atorvastatin 80 mgMean LDL-C 77 mg/dL

Event rate 8.7%

22% RRR (p<0.001)

0.15

0.10

0.05

0M

ajor

CV

even

t (%

)

PROVE-IT TNT

Intensive LDL-C Lowering Improves Intensive LDL-C Lowering Improves Patient OutcomesPatient Outcomes

.

All-cause death or major cardiovascular events in all randomised subjects

Major cardiovascular events in all randomised subjects

Relationship Between Changes in Relationship Between Changes in LDL-C and HDL-C Levels and CHD RiskLDL-C and HDL-C Levels and CHD Risk

Third Report of the NCEP Expert Panel. NIH Publication No. 01-3670 2001. http://hin.nhlbi.nih.gov/ncep_slds/menu.htm

1% decreasein LDL-C reduces

CHD risk by1%

1% decreasein HDL-C increases

CHD risk by2-3%

Many Patients that are Treated are Still not Many Patients that are Treated are Still not Getting to GoalGetting to Goal

2829 patients†

1464 (52%) not at goal on

starting dose

1365 (48%) at goal on starting

dose

813 (55%) not

titrated651 (45%)

titrated

448 (69%)not at goal

†Patients with an LDL-C goal of <100mg/dL (CHD and/or diabetes mellitus) with HDL-C <45 mg/dL

Foley KA, Simpson RJ, Crouse JR et al. Am J Cardiol 2003;92:79-81

203 (31%) at goal

Even With Dose Titration, Many Patients Even With Dose Titration, Many Patients Fail to Achieve LDL-C Goals Fail to Achieve LDL-C Goals

The ACCESS StudyThe ACCESS Study

At week 54, n=2543 CHD patients

Ballantyne CM et al. Am J Cardiol 2001;88:265–269

Pati

e nt s

at

L DL -

C go

al (

%)

0

20

40

60

80 Atorvastatin 10–80 mgSimvastatin 10–40 mgLovastatin 20–80 mgFluvastatin 20–80 mgPravastatin 10–40 mg

Evolution of Lipid Management Guidelines – Evolution of Lipid Management Guidelines – Driving the Need for More Effective Statin Driving the Need for More Effective Statin

TherapyTherapy

Lower LDL-C goals; wider target population; need for more effective therapies.

ATP III2001

ATP II 1993

ATP I 1988

European2003

European1998

European1994

ATP III update2004

Addressing The Unmet Medical Need in the Addressing The Unmet Medical Need in the Treatment of DyslipidaemiaTreatment of Dyslipidaemia

A need exists for more efficacious therapy to achieve:

– greater LDL-C reductions at low dose – greater LDL-C reductions across the dose range

– more patients to guideline LDL-C goals

– improved HDL-C raising

CRESTORCRESTOR®®

EfficacyEfficacy

CRESTORCRESTOR®® reduces LDL-C reduces LDL-C by up to 63%by up to 63%

*p<0.001 vs placebo

Adapted from Olsson A. Cardiovasc Drug Rev 2002;20:303–328

Placebo

–7

5

–52*

20

–55*

40

–63*–70

–60

–50

–40

–30

–20

–10

0n=13 n=17 n=17 n=18

Rosuvastatin dose (mg)

Chan

ge in

LD

L-C

from

ba

selin

e (%

)

10n=17

–45 *

Jones PH et al. Am J Cardiol 2003;92:152–160

Patients (n=2288)Hypercholesterolaemia 18 years

atorvastatin 40 mg (n=160)

pravastatin 10 mg (n=162)

simvastatin 10 mg (n=167)simvastatin 20 mg (n=164)simvastatin 40 mg (n=159)simvastatin 80 mg (n=165)

atorvastatin 80 mg (n=167)

pravastatin 40 mg (n=164)pravastatin 20 mg (n=166)

rosuvastatin 10 mg (n=158)

rosuvastatin 40 mg (n=158)atorvastatin 10 mg (n=158)atorvastatin 20 mg (n=156)

rosuvastatin 20 mg (n=164)

LipidsSafety

LipidsSafety

Lipids Safety

Visit:Week:

1–6

40

2–2

3–1

66

54

Dietary run in / eligibility

CRESTORCRESTOR®® vs Comparatorsvs ComparatorsThe STELLAR StudyThe STELLAR Study

Rosuvastatin Atorvastatin SimvastatinPravastatin

*p<0.002 vs atorvastatin 10 mg; simvastatin 10, 20, 40 mg; pravastatin 10, 20, 40 mg†p<0.002 vs atorvastatin 20, 40 mg; simvastatin 20, 40, 80 mg; pravastatin 20, 40 mg‡p<0.002 vs atorvastatin 40 mg; simvastatin 40, 80 mg; pravastatin 40 mg

Adapted from Jones PH et al. Am J Cardiol 2003;92:152–160

*

X

X

X

–60

–50

–40

–30

–20

–10

0

Dose, mg (log scale)10 20 40 80

X

X

n=648

n=473n=634

n=485

† ‡

Chan

ge in

LD

L-C

from

ba

selin

e (%

)

LDL-C Efficacy Across the Dose RangeLDL-C Efficacy Across the Dose RangeThe STELLAR StudyThe STELLAR Study

LDL-C efficacy at 10mg DoseLDL-C efficacy at 10mg Dose The STELLAR StudyThe STELLAR Study

Change in LDL-C from baseline (%)0 –10 –20 –30 –40 –50 –60

10mg*

–5 –15 –25 –35 –45 –55

20mg†

40mg‡

10mg

20mg

80 mg

10mg

20mg

40mg

80mg

10mg

20mg

40mg Rosuvastatin 10 mg (–46%)

RosuvastatinAtorvastatinSimvastatinPravastatin

40mg

*p<0.002 vs atorvastatin 10 mg; simvastatin 10, 20, 40 mg; pravastatin 10, 20, 40 mg†p<0.002 vs atorvastatin 20, 40 mg; simvastatin 20, 40, 80 mg; pravastatin 20, 40 mg‡p<0.002 vs atorvastatin 40 mg; simvastatin 40, 80 mg; pravastatin 40 mg


Blasetto JW et al. Am J Cardiol 2003;91(Suppl):3C–10C. Please consult local Prescribing Information for guidance on the use of CRESTOR

*p<0.001 vs. atorvastatin 10 mg

-50

-40

-30

-20

-10

0

-60

-42%

* -47%

-36%

n=390 n=389 n=393

Chan

ge in

LD

L-C

from

ba

selin

e (%

)

* CRESTOR 5 mg CRESTOR 10 mgatorvastatin 10 mg

Pooled data - Blasetto12 weeks

CRESTORCRESTOR®® 5 mg provides greater LDL-C 5 mg provides greater LDL-C reductions than Atorvastatin 10 mg reductions than Atorvastatin 10 mg

CRESTORCRESTOR®® 10 mg versus Atorvastatin 10 mg 10 mg versus Atorvastatin 10 mg Consistently Greater LDL-C ReductionsConsistently Greater LDL-C Reductions

*p<0.001 vs atorvastatin

Jones PH et al. Am J Cardiol 2003;92:152–160 Schuster H et al. Am Heart J 2004; 147: 705-712 Davidson M et al. Am J Cardiol 2002;89:268–75Schwartz G et al. Am Heart J 2004: 148:e4:H1-H9Olsson AG et al. Am Heart J 2002;144:1044–51Blasetto JW et al. Am J Cardiol 2003;91(Suppl):3C–10C

n=15

8

n=53

9

n=52

9

n=12

9

n=12

7

n=12

8n=

127

n=13

2n=

139

n=38

9n=

393

–47–50

–47–43

–46 –47

–36–39

–35–35–37–37

–60

–50

–40

–30

–20

–10

0Jones Schuster Davidson Schwartz Olsson Blasetto

Rosuvastatin 10 mgAtorvastatin 10 mg

n=15

6n=

158

n=53

9

n=52

9

n=12

7

n=12

8n=

127

n=13

2n=

139

n=38

9n=

393

6 weeksSTELLAR

8 weeksMERCURY I

12 weeksPooled data

n=52

9

n=12

9

** *

6 weeksSTELLAR

8 weeksMERCURY I

12 weeksPooled data

n=52

9

***

Chan

ge in

LD

L-C

from

ba

selin

e (%

)

Jones PH et al. Am J Cardiol 2003;92:152–160. Jukema J et al. Curr Med Res 2005 in press Wolffenbuttel et al. Journal of Internal Medicine 2005; 257: 531-539Clearfield M et al. Atherosclerosis Supplements 2005;6(1)104 Abs W16-P-014Schuster H et al. Am Heart J 2004;147:705–712.

*p<0.05, **p<0.001 vs. atorvastatin 20 mg CRESTOR 10 mg atorvastatin 20 mg

-50

-40

-30

-20

-10

0

-60

6 weeksSTELLAR

Jones

ns

-46%-43%

*

-44%

-38%

RADARJukema

n=156 n=155 n=230 n=231

-46%-41%

*

CORALLWolffenbuttel

n=131 n=132

MERCURY ISchuster

**

-47%-44%

8 weeks

n=539 n=925

Chan

ge in

LD

L-C

from

ba

selin

e (%

)

-45% -43%

*

PULSARClearfield

n=493 n=481

CRESTORCRESTOR®® 10 mg versus Atorvastatin 20 mg 10 mg versus Atorvastatin 20 mg Provides Greater LDL-C ReductionsProvides Greater LDL-C Reductions

*p<0.01, **p<0.001, ***p<0.0001 vs atorvastatin 80 mg;

CRESTORCRESTOR®® 40 mg versus Atorvastatin 80 mg 40 mg versus Atorvastatin 80 mg Provides Greater LDL-C ReductionsProvides Greater LDL-C Reductions

Jones PH et al. Am J Cardiol 2003;92:152–160.Leiter LA et al. Atherosclerosis Supplements 2005; 6 (1) 113 Abs W16-P-051 Wolffenbuttel et al. Journal of Internal Medicine 2005; 257: 531-539 Jukema J et al. Curr Med Res 2005 in press

Rosuvastatin 40 mg Atorvastatin 80 mg

-50

-40

-30

-20

-10

0

-60

6 weeksPOLARIS

LeiterSTELLAR

Jones

-55-51

***

-54

-48

**

-55

-48

*-56

-52

CORALLWolffenbuttel

RADARJukema

n=157 n=165 n=428 n=432 n=230 n=231 n=130 n=132

Chan

ge in

LD

L-C

from

ba

selin

e (%

)8 weeks 18 weeks

ns

CRESTORCRESTOR®® versus other statins versus other statinsAchievement of Achievement of LDL-C Goals Across Dose RangeLDL-C Goals Across Dose Range

Patients achieving 2003 European LDL-C goals‡

Kritharides L. Eur Heart J Suppl 2004;6(Suppl A):A12-A18

*p<0.002 vs atorvastatin 10 mg; simvastatin 10, 20, 40 mg; pravastatin 10, 20, 40 mg†p<0.002 vs atorvastatin 20 mg; simvastatin 20, 40 mg; pravastatin 20, 40 mg#p<0.002 vs atorvastatin 40 mg; simvastatin 40, 80 mg; pravastatin 40 mg

Pati

ents

ach

ievi

ng 2

003

Euro

pean

LD

L-C

goal

s (%

)

‡LDL-C <3mmol/l (115mg/dl) in general; <2.5mmol/l (97mg/dl) for patients with clinically established CVD or type 2 diabetes

Rosuvastatin

69%

44%

20%

3%

87%

58%

36%

12%

83%

72%

48%

22%

75%

66%

0

20

40

60

80

100

*

†# Atorvastatin

PravastatinSimvastatin

n=156 n=160 n=15710mg 20mg 40mg

n=158 n=155 n=156n=16510mg 20mg

n=165 n=162 n=158 n=16310mg 20mg 40mg 80mg40mg 80mg

n=160 n=16420mg 40mg10mg

n=161

Jones PH et al. Am J Cardiol 2003;92:152–160

0

20

40

60

80

100

n=156 n=160 n=15710mg 20mg 40mg

n=158 n=155 n=156 n=16510mg 20mg

n=165 n=162 n=158 n=16310mg 20mg 40mg 80mg40mg 80mg

n=160 n=16420mg 40mg10mg

n=161

82%

89%89%

69%75%

85%82%

51%

63%66%

82%

31%

44%

55%

*

† ‡

*p<0.002 vs. simvastatin 10 mg and 20 mg; pravastatin 10 mg, 20 mg and 40 mg†p<0.002 vs. atorvastatin 20 mg, simvastatin 20mg and 40 mg; pravastatin 20 mg and 40 mg‡p<0.002 vs. simvastatin 40 mg and pravastatin 40 mg

Pati

ents

ach

ievi

ng t

heir

NCE

P AT

P III

LD

L-C

goal

s (%

)

#LDL-C goal <100mg/dl for high-risk; <130 for medium risk & <160 for low-risk patients

RosuvastatinAtorvastatin


CRESTORCRESTOR®® versus other statins versus other statinsAchievement of Achievement of LDL-C Goals Across Dose RangeLDL-C Goals Across Dose Range

Patients achieving NCEP ATP III LDL-C goals#

CRESTORCRESTOR®® versus Atorvastatin versus Atorvastatin Change in HDL-CChange in HDL-CThe STELLAR StudyThe STELLAR Study

*p<0.002 vs atorvastatin 20, 40 and 80 mg†p<0.002 vs atorvastatin 40 and 80 mg Adapted from Jones PH et al. Am J Cardiol 2003;92:152–160

0

2

4

6

8

10

12

10

AtorvastatinRosuvastatin

20 40 80

ns

* †

n=473

n=634

Dose (mg); log scale

Chan

ge in

HD

L-C

from

ba

selin

e (%

)

CRESTORCRESTOR®® versus other statins versus other statins Change in HDL-CChange in HDL-C TheThe STELLAR StudySTELLAR Study

*p<0.002 vs pravastatin 10 mg†p<0.002 vs atorvastatin 20, 40, 80 mg; simvastatin 40 mg; pravastatin 20, 40 mg‡p<0.002 vs atorvastatin 40, 80 mg; simvastatin 40 mg; pravastatin 40 mgObserved data in ITT population


10 20 40

3.2

4.45.6

10 20 40 80 10 20 40 0

2

4

6

8

10

12

5.74.8 4.4

2.1

*7.7

†9.5

‡9.6

10 20 40 80

5.36.0

5.2

6.8

Dose (mg)



Chan

ge in

HD

L-C

from

ba

selin

e (%

)

CRESTORCRESTOR®® versus other statins versus other statins Change in TriglyceridesChange in Triglycerides

The STELLAR StudyThe STELLAR Study

*p<0.002 vs pravastatin 10, 20 mg†p<0.002 vs simvastatin 40 mg; pravastatin 20, 40 mg‡p<0.002 vs simvastatin 40 mg; pravastatin 40 mg


Dose (mg)

–20

–23

–27–28

–12

–18

–15

–18

10 20 40 80

–24

† –26

‡

–20

*

10 20 40 10 20 40 80

–8 –8

–13

10 20 40

–30

–25

–20

–15

–10

0

–5



Chan

ge in

TG

from

ba

selin

e (%

)

Rosuvastatin is the more effective statin at lowering LDL-C10-21

– highly effective reductions in LDL-C of up to 63%– greater LDL-C lowering versus atorvastatin

Rosuvastatin 10 mg can reduce LDL-C by approximately 50% and produces:-

– greater reductions in LDL-C than the same and some higher doses of other statins11-18

– greater reductions in LDL-C than atorvastatin 10 and 20 mg 13,17,18,19.

– greater achievement of LDL-C goals than commonly prescribed doses of other statins, avoiding the need to titrate to higher doses11,17,19,21,25.

Rosuvastatin produces a significant increase in HDL-C which is maintained across the dose range11

CRESTORCRESTOR®® Efficacy Summary Efficacy Summary

CRESTORCRESTOR®® Safety ProfileSafety Profile

– Male; 6,530 (53%), Female; 5,870 (47%)– Mean age 58 years, – No upper age limit; 3,894 (31%) ≥ 65 years– Diabetes mellitus; 2,073 (17%)– Hypertension; 6,472 (52%)– Coronary heart disease; 4,487 (36%)– Renal impairment:-

– Mild; 5,513 (44%)– Moderate; 975 (8%)– Severe; 39 (0.3%)

Shepherd J et al. Am J Cardiol 2004;94:882-888

Overall safety & adverse event profile as Overall safety & adverse event profile as determined by controlled clinical trialsdetermined by controlled clinical trials

The Rosuvastatin Clinical Development Programme (n=12,400) included a wide range of patients treated with rosuvastatin 5-40 mg, including many at increased cardiovascular risk, reflecting those seen in general medical practice:-

Rosuvastatin is generally well tolerated with an adverse event profile similar to currently marketed statins

Most common related adverse events - myalgia, asthenia, abdominal pain, nausea (mild and transient)

Well tolerated regardless of age, sex, ethnicity, presence of co-morbidities or concomitant medications

Similar number of adverse events leading to withdrawal as other currently marketed statins


CRESTORCRESTOR®® overall safety & adverse event overall safety & adverse event profileprofile

Percentage of patients with an adverse event leading to withdrawal

0

2

4

6

8

rosuvastatin simvastatin pravastatin

Pati

ent s

(%

)

1

3

5

7

3.2%2.5% 2.5%

(n=3912) (n=1457) (n=1278)

3.2%

atorvastatin(n=2899)

10–40 mg10–80 mg10–80 mg5–40 mg


CRESTORCRESTOR®® overall safety & adverse event overall safety & adverse event profileprofile

CRESTORCRESTOR®® Safety Summary Safety Summary

Tolerability profile has been well-researched in a large number of patients representing ‘real population’

Overall tolerability profile of rosuvastatin is similar to that seen with currently marketed statins– well tolerated with a low rate of withdrawals due to adverse

events – adverse events usually mild and transient – rhabdomyolysis is very rare with rosuvastatin (<0.01%) which is

in line with that reported for other currently marketed statins– renal function was maintained or tended to improve slightly with

long-term treatment Favourable benefit–risk profile

Clinical Pharmacology of Clinical Pharmacology of CRESTORCRESTOR®®

Pharmacokinetic Profile of Selected StatinsPharmacokinetic Profile of Selected Statins

Rosuvastatin Atorvastatin Simvastatin Pravastatin

CYP450 3A4 metabolism

No Yes Yes No

Clinically significant metabolites

No Yes Yes No

Plasma clearance Dual renal / hepatic

Primarily hepatic

Dual renal / hepatic

Dual renal / hepatic

Relatively hydrophilic Yes No No Yes

Bioavailability (%) 20 12 <5 18

Elimination half-life (hours)

20 11-14 3 2

CRESTORCRESTOR®® Dosing and Dosing and AdministrationAdministration

CRESTORCRESTOR®® - Dosing and Administration - Dosing and Administration

Dose range 5–40 mg Usual start dose 5mg or 10mg

– Dependent on level of lipid lowering required Maximum LDL-C response within 4 weeks

– significant response within 2 weeks Once daily, any time of day, with or without food

Please refer to local Prescribing Information

GALAXY ProgrammeGALAXY ProgrammeTMTM

The GALAXY ProgrammeTM is a large, comprehensive, long-term and evolving global research initiative sponsored by AstraZeneca investigating cardiovascular risk reduction and patient outcomes with rosuvastatin

It has been designed to build on current thinking to address important unanswered questions in statin research

Includes studies investigating the effects of rosuvastatin on:– atherogenic lipid profile and inflammatory markers– atherosclerosis– outcomes

Will provide additional short- and long-term efficacy and safety data for rosuvastatin

Designed to evaluate whether these effects translate into beneficial effects on atherosclerosis and significant reductions in cardiovascular events.

Schuster H & Fox J. Exp Opin Pharmacother 2004;5:1187-1200

CRESTORCRESTOR®® - Overall Summary - Overall Summary CRESTOR® produces beneficial effects on key lipid

parameters across the dose range– the more effective statin at lowering LDL-C with greater LDL-C

lowering versus atorvastatin in more than 17 comparative studies involving >16,000 patients

– rosuvastatin 10 mg can reduce LDL-C by approximately 50% and has been shown to reduce LDL-C more than atorvastatin 10 mg and 20 mg

– rosuvastatin 10 mg gets more patients to their LDL-C goal than commonly prescribed doses of other currently marketed statins, avoiding the need to titrate to higher doses

– significant increase in HDL-C which is maintained across the dose range

Tolerability and safety profile similar to other currently marketed statins

Low potential for significant drug–drug interactions Has a comprehensive clinical development programme

Schuster H. Improving lipid management – to titrate, combine or switch. Int J Clin Pract, July 2004, 58, 7, 689-694 Gould AL, Rossouw JE, Santanello NC et al. Cholesterol reduction yields clinical benefit: impact of statin trials. Circulation 1998;97:946–952.Rosensen RS. Statins: can the new generation make an impression? Exp Opin Emerg Drugs 2004;9(2):269-279.LaRosa J, Grundy S, Waters D, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425-1435.Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7–22.Cannon C, Braunwald E, McCabe C et al. Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes. N Engl J Med 2004;350 (15):1495-1504Third Report of the NCEP Expert Panel. NIH Publication No. 01-3670 2001. http://hin.nhlbi.nih.gov/ncep_slds/menu.htmFoley KA, Simpson RJ, Crouse JR et al. Effectiveness of Statin Titration on Low-Density Lipoprotein Cholesterol Goal Attainment in Patients at High Risk of Atherogenic Events. Am J Cardiol 2003;92:79-81Ballantyne CM, Andrews TC, Hsia JA et al. Correlation of non-high-density lipoprotein cholesterol with apolipoprotein B: effect of 5 hydroxymethylglutaryl coenzyme A reductase inhibitors on non-high-density lipoprotein cholesterol levels. Am J Cardiol 2001;88:265–269 Olsson A, McTaggart F, Raza A. Rosuvastatin – A highly effective new HMG-Co A reductase inhibitor. Cardiovasc Drug Rev 2002;20:303–328Jones PH, Davidson MH, Stein EA et al for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial) Am J Cardiol 2003;92:152–160Blasetto JW, Stein EA, Brown WV et al. Efficacy of Rosuvastatin Compared with Other Statins as Selected Starting Doses in Hypercholesterolemic Patients and in Special Population Groups. Am J Cardiol 2003;91(Suppl):3C–10C.Schuster H, Barter PJ, Stender S et al. Effect of switching to rosuvastatin from atorvastatin or other statins on achievement of international low-density lipoprotein cholesterol goals: MERCURY I trial. Am Heart J 2004;147:705-712 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;89:268–275 Schwartz GG, Bolognese MA, Tremblay BP et al. Efficacy and safety of rosuvastatin and atorvastatin in patients with hypercholesterolemia and a high risk of coronary heart disease: a randomized, controlled trial. Am Heart J 2004:148:e4:H1-H9Olsson AG, Istad H, Luurila O et al. Effect of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Am Heart J 2002;144:1044–1051Jukema J, Liem AH, Dunselman PHJM et al. LDL/HDL-C ratio in patients with cardiovascular disease and low HDL-C: results of the the RADAR (Rosuvastatin and Atorvastatin in different Dosages And Reverse cholesterol transport) study. Current Medical Research 2005 in press.Wolffenbuttel B et al. Cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes – CORALL study. J Int Med 2005;257:531-539Clearfield M, Amerena J, Bassand JP et al. Efficacy and safety of rosuvastatin 10mg versus atorvastatin 20mg: results of the PULSAR study. Atherosclerosis Supplements 2005;6(1)104 Abs W16-P-014. Leiter LA, Rosenson RS, Stein E et al. Rosuvastatin 40mg versus atorvastatin 80mg in high-risk patients with hypercholesterolaemia: early results results of the POLARIS study. Atherosclerosis Supplements 2005;6(1):113 Abs W16-P-051.Kritharides L. Reducing low-density lipoprotein cholesterol – treating to target and meeting new European goals. Eur Heart J Suppl 2004;6(Suppl A): A12-A18. Shepherd J, Hunninghake DB, Stein EA et al. Safety of rosuvastatin. Am J Cardiol 2004;94:882-888White, CM. A Review of the Pharmacologic and Pharmacokinetic Aspects of Rosuvastatin. J Clin Pharm, 2002;42:963-970McTaggart F, Buckett L, Davidson R et al. Preclinical and clinical pharmacology of rosuvastatin, a new 3- hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am J Cardiol 2001;87(Suppl):28B–32BSchuster H, Fox J, Investigating cardiovascular risk reduction – the Rosuvastatin GALAXY Programme. Exp Opin Pharmacother 2004;5(5):1187-1200

References

Documents

CRESTOR Launch Presentation January 2011