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JUPITER. J ustification for the U se of statins in P rimary prevention: an I ntervention T rial E valuating R osuvastatin. Rosuvastatin is not indicated for the treatment of patients with high C-Reactive Protein (CRP).

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JUPITER

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Jupiter l.jpg

JUPITER

Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin

Rosuvastatin is not indicated for the treatment of patients with high C-Reactive Protein (CRP).

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Jupiter2 l.jpg

JUPITER

  • JUPITER is the first large-scale, prospective study to examine the role of statin therapy in individuals with low to normal LDL-C levels, but with increased cardiovascular risk identified by elevated CRP

  • It assessed the long-term impact of rosuvastatin (CRESTOR™) in individuals potentially at increased cardiovascular (CV) risk due to elevated CRP levels who do not qualify for lipid-lowering treatment according to current guidelines

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Jupiter rationale l.jpg

JUPITER - Rationale

  • Nearly half of all cardiovascular events occur in patients who are apparently healthy and who have low or normal levels of LDL-C

  • hsCRP predicts cardiovascular disease independent of LDL-C levels

  • Along with improved screening there is a need to examine the use of lipid-lowering agents as a method of reducing the risk of cardiovascular events

Ridker PM. New Engl J Med 2002; 347: 1557–1565

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Prevalence of conventional risk factors in male patients with chd l.jpg

Prevalence of conventional risk factors† in male patients with CHD

Four (0.9%)

Three

None

8.9%

19.4%

Two

27.8%

43.0%

One

Total male patients=87 869CHD=coronary heart disease

†smoking, hypertension, hypercholesterolaemia and diabetes mellitus

Khot UN et al. JAMA 2003; 290: 898–904.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Slide5 l.jpg

8

7

6

5

4

3

2

1

0

CRP Epidemiology

CRP levels in the US, NHANES 1999-2000

Men

Women

33.3

Percentile

50

66.7

CRP, mg/L

30-39

40-49

50-59

60-69

70-79

80+

30-39

40-49

50-59

60-69

70+

Age (yrs)

Age (yrs)

Ford ES, Giles WH, Myers GL, Mannino DM. Clin Chem 2003; 49(4):686-90.

Ford ES, Giles WH, Mokdad AH, Myers GL. Clin Chem 2004; 50(3):574-81.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Crp contributes to all stages of atherosclerosis l.jpg

CRP contributes to all stages of atherosclerosis

Roles

of CRP

  • Endothelial

  • Dysfunction

  •  Vasodilation

  • NO

  • Endothelial

  • activation

  • Monocyte

    adhesion

  • Endothelial

    progenitor cells

  • Plaque

  • progression

  • Monocyte

    migration

  • VSMC

    proliferation

  • Plaque Rupture

  • /Thrombosis

  • Capthinning

  • TF secretion

     Fibrinolysis

Progression of atherosclerosis

NO: Nitric oxide, VSMC: Vascular Smooth Muscle Cell, TF: Tissue factor

Bisoendial RJ, Kastelein JJP, Stroes ESG. Atherosclerosis 2007; 195:e10-18

Packard RRS, Libby P. Clin Chem 2008; 54:24-38

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Crp is a stronger predictor of future events compared with other markers in women l.jpg

Lp(a)

Homocysteine

IL-6

TC

LDL-C

sICAM-1

SAA

ApoB

TC/HDL-C

CRP

CRP + TC/HDL-C

1.0

2.0

4.0

6.0

0

Relative risk of future cardiovascular events

CRP is a stronger predictor of future events compared with other markers in women

CRP=C-reactive protein; Lp(a)=lipoprotein (a); IL=interleukin; TC=total cholesterol; LDL-C=low-density lipoprotein cholesterol; sICAM-1=soluble intercellular adhesion molecule 1; SAA=serum amyloid A; Apo=apolipoprotein; HDL-C=high-density lipoprotein cholesterol

Blake GJ, Ridker PM. Circ Res 2001; 89: 763–771.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Crp predicts risk of mi and stroke in apparently healthy men l.jpg

CRP predicts risk of MI and stroke in apparently healthy men

*

3.5

2.0

***

3.0

1.5

2.5

Relativerisk of ischaemicstroke

Relative risk of MI

2.0

1.0

1.5

1.0

0.5

0.5

0

0

1

2

3

4

1

2

3

4

Quartile of CRP

Quartile of CRP

CRP=C-reactive protein; MI=myocardial infarction*p=0.03 vs quartile 1; ***p<0.001 vs quartile 1

Ridker PM et al. N Engl J Med 1997; 336: 973–979.

Quartile 1: ≤ 0.55 ; Quartile 2: ≤ 0.56-1.14;

Quartile 3: 1.15-2.10 ; Quartile 4:  2.11.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Rate of cardiovascular events in women in relation to ldl c and crp l.jpg

Rate of cardiovascular events in women in relation to LDL-C and CRP

100

10

CRP (mg/L)

1

0.1

1.3

2.6

3.9

5.2

6.5

LDL-C (mmol/L)

LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive proteinRidker PM et al. N Engl J Med 2002; 347: 1557–1565.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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Cardiovascular event-free survival in women using combined LDL-C and CRP measurements

1.00

Low LDL-C, low CRP

0.99

Probability of event-free survival

High LDL-C, low CRP

0.98

Low LDL-C, high CRP

0.97

High LDL-C, high CRP

0.96

0

LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive proteinMedian LDL-C=3.2 mmol/L (124 mg/dL)

Median CRP=1.5 mg/LRidker PM et al. N Engl J Med 2002; 347: 1557–1565.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Ldl c and crp as markers of cardiovascular events the afcaps texcaps study l.jpg

LDL-C and CRP as markers of cardiovascular events – the AFCAPS/TexCAPS study

Median LDL-C=3.9 mmol/L (149 mg/dL). Median CRP=1.6 mg/L

LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive protein; NNT=number needed to treat to prevent one coronary event; na=not applicable.

Ridker PM et al. N Engl J Med 2001; 344: 1959–1965.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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CRP is a strong independent predictor of future CV events

  • CRP is a strong independent predictor of cardiovascular events1

  • Addition of CRP to the Framingham algorithm improves global cardiovascular risk prediction2

  • CRP and LDL-C are complementary biomarkers for identifying at-risk individuals3

1. Ridker PM. JACC 2007;49:2129-38.

2. Ridker PM. JAMA 2007;297:611-9.

3. Ridker PM et al. N Engl J Med 2002; 347: 1557–1565.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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JUPITER - Objective

  • The primary objective was to investigate whether long-term treatment with rosuvastatin 20 mg decreases the rate of first major cardiovascular events compared with placebo in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated CRP levels

Ridker PM. Circulation 2003; 108: 2292–2297

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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JUPITER – study design

No history of CAD

men ≥50 yrs

women ≥60 yrs

LDL-C <3.36 mmol/L

CRP ≥2.0 mg/L

Rosuvastatin 20 mg (n~8900)

Placebo

run-in

Placebo (n~8900)

Visit:Week:

1–6

2–4

30

413

Final3–4 y

6-month

intervals

Lead-in/eligibility

Randomisation

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

HbA1C

CAD=coronary artery disease; LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive protein; HbA1c=glycated haemoglobin

Ridker PM. Circulation 2003; 108: 2292–2297. Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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JUPITER - Study Endpoints

  • Primary Endpoint

    • Time to the first occurrence of a major cardiovascular event, composite of:

      • cardiovascular death

      • Stroke

      • MI

      • unstable angina

      • arterial revascularisation

  • Secondary Endpoints:

    • total mortality

    • non-cardiovascular mortality

    • development of diabetes mellitus

    • development of venous thromboembolic events

    • bone fractures

    • discontinuation of study medication due to adverse effects.

Ridker PM. Circulation 2003; 108: 2292–2297


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JUPITER – study design

No history of CAD

men ≥50 yrs

women ≥60 yrs

LDL-C <3.36 mmol/L

CRP ≥2.0 mg/L

Rosuvastatin 20 mg (n~8900)

Placebo

run-in

Placebo (n~8900)

Visit:Week:

1–6

2–4

30

413

Final3–4 y

6-month

intervals

Lead-in/eligibility

Randomisation

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

HbA1C

CAD=coronary artery disease; LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive protein; HbA1c=glycated haemoglobin

Ridker PM. Circulation 2003; 108: 2292–2297. Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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JUPITER – study endpoints

  • Primary

    • time to the first occurrence of a major cardiovascular event (cardiovascular death, stroke, MI, unstable angina or arterial revascularisation)

  • Secondary

    • Efficacy (incident diabetes mellitus, venous thromboembolic events, bone fractures)

    • Safety (total mortality noncardiovascular mortality, adverse events)

Ridker PM. Circulation 2003; 108: 2292–2297.

Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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Major inclusion criteria

  • Men aged ≥50 years; women aged ≥60 years

  • Fasting LDL-C levels 3.36 mmol/L, CRP levels ≥2.0 mg/L and TG levels 5.65 mmol/L on initial screening

Ridker PM. Circulation 2003; 108: 2292–2297.

Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Major exclusion criteria l.jpg

Major exclusion criteria

  • Current use of statinsor other lipid-lowering therapies

  • Prior history of cardiovascular or cerebrovascular events, such as MI, unstable angina, prior arterial revascularisation or stroke, or CHD-risk equivalents

  • Chronic inflammatory condition, such as severe arthritis, lupus or inflammatory bowel disease

  • CK 3 x ULN

MI=myocardial infarction; CHD=coronary heart disease; ULN=upper limit of normal

Ridker PM. Circulation 2003; 108: 2292–2297.

Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Jupiter major exclusion criteria l.jpg

JUPITER - Major exclusion criteria

  • Current use of statinsor other lipid-lowering therapies

  • Current use of hormone replacement therapy

  • Prior history of cardiovascular or cerebrovascular events, such as MI, unstable angina, prior arterial revascularisation or stroke, or CHD-risk equivalents

  • Chronic inflammatory condition, such as severe arthritis, lupus or inflammatory bowel disease and/or treatment with immunosuppressants

  • Uncontrolled:

    • hypertension: SBP > 190 mmHg or DBP > 100 mmHg

    • hypothyroidism: TSH > 1.5 x ULN

  • CK 3 x ULN

  • Serum creatinine > 2.0 mg/dL

  • Evidence of hepatic dysfunction (ALT > 2 x ULN)

  • History of prior malignancy, alcohol or drug abuse

Ridker PM. Circulation 2003; 108: 2292–2297

CHD = coronary heart disease; CK = creatinine kinase; ULN = upper limit of normal; SBP = systolic blood pressure; DBP = diastolic blood pressure

Ridker P et al. N Eng J Med 2008;359: 2195-2207


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JUPITER - PatientFlow

89,890 subjects screened

17,802 randomized

Rosuvastatin 20mg

n=8,901

Placebo

n=8,901

Lost to follow up

n=44

Lost to follow up

n=37

Completed study

n=8,857

Completed study

n=8,864

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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JUPITER - Baseline characteristics*

Rosuvastatin Placebon=8901 n=8901

Age (years)66 (60-71) 66 (60-71)

Male sex (%) 61.562.1

Race (%)

White71.471.1

Black12.412.6

Hispanic12.612.8

Other3.63.5

BMI (kg/m2)28.3 (25.3-32.0)28.4 (25.3-32.0)

Systolic BP (mmHg)134 (124-145)134 (124-145)

Diastolic BP (mmHg)80 (75-87)80 (75-87)

*All values are median (interquartile range) or N (%).

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


Slide23 l.jpg

JUPITER - Baseline laboratory parameters*

RosuvastatinPlacebon=8901 n=8901

Total cholesterol (mg/dL)4.81 (4.34-5.17) 4.78 (4.37-5.15)

LDL cholesterol (mg/dL)2.69 (2.43-3.08)2.69 (2.43-3.08)

HDL cholesterol (mg/dL) 1.27 (1.03-1.55)1.27 (1.03-1.55)

Triglycerides (mg/dL)1.33 (0.96-1.91)1.33 (0.97-1.90)

hsCRP (mg/L) 4.2 (2.8-7.1)4.3 (2.8-7.2)

Glucose(mg/dL)94 (87-102)94 (88-102)

HbA1c(%)5.7 (5.4-5.9)5.7 (5.5-5.9)

Glomerular filtration rate,

(ml/min/1.73m2) 73.3 (64.6-83.7)73.6 (64.6-84.1)

For hsCRP, values are the average of the values obtained at two screening and visits

*All values are median (interquartile range) or N (%).

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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JUPITER - Medical History

Medical HistoryRosuvastatin Placebo n=8901 n=8901

Current smoker (%)15.716.0

Family history CHD†(%) 11.211.8

Metabolic syndrome‡(%)41.041.8

Aspirin use (%)16.616.6

†Family history of premature CHD defined as first degree relative with CHD at age < 55 yrs (male), < 65 yrs (female); ‡ Metabolic syndrome defined according to consensus criteria of AHA/NHLBI

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


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JUPITER population compared with previous trials in patients without established CHD

CVD=cardiovascular disease; CHD=coronary heart disease; LDL-C=low-density lipoprotein cholesterol; HDL-C=high-density lipoprotein cholesterol; hsCRP=high sensitivity C-reactive protein; *Baseline lipid levels are mean values.

Ridker PM et al. Am J Cardiol 2007; 100: 1659–1664

Ridker PM et al. N Engl J Med. 2001 344: 1959-65


Slide26 l.jpg

JUPITER - Primary EndpointTime to first occurrence of a CV death, non-fatal stroke, non-fatalMI, unstable angina or arterial revascularization

9

Hazard Ratio 0.56

(95% CI 0.46-0.69)

P<0.00001

Placebo

8

7

6

5

Rosuvastatin 20 mg

Percent of patients with

primary endpoint

4

3

NNT for 2y = 95

5y* = 25

2

1

0

0

1

2

3

4

5

Years

Number at risk

RSV 8901 8412 3893 1353 538 157

Placebo 8901 8353 3872 1333 531 174

Ridker P et al. N Eng J Med 2008;359: 2195-2207

*Extrapolated figure based on Altman and Andersen method


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JUPITER - Primary Endpoint Components

  • PlaceboRosuvastatinHR95% CIp-value[n=8901][n=8901]

  • n (rate**) n (rate**)

  • Primary Endpoint 251 (1.36) 142 (0.77)0.560.46-0.69 <0.001*

    (Time to first occurrence of CV death, MI, stroke, unstable angina, arterial revascularisation)

    Non-fatal MI 62 (0.33) 22 (0.12)0.350.22-0.58 <0.001*

    Fatal or non-fatal MI 68 (0.37) 31 (0.17)0.460.30-0.700.0002

    Non-fatal stroke 58 (0.31) 30 (0.16)0.520.33-0.800.003

    Fatal or non-fatal stroke 64 (0.34) 33 (0.18)0.520.34-0.790.002

    Arterial Revascularization 131 (0.71) 71 (0.38)0.540.41-0.72 <0.0001

    Unstable angina† 27 (0.14) 16 (0.09)0.590.32-1.100.09

    CV death, stroke, MI 157 (0.85) 83 (0.45)0.530.40-0.69 <0.001*

    Revascularization

    or unstable angina 143 (0.77) 76 (0.41)0.530.40-0.70 <0.001*

    ** Rates are per 100 person years;† Hospitalisation due to unstable angina; *Actual p-value was < 0.00001

    HR – Hazard Ratio; CI – Confidence Limit

    Ridker P et al. N Eng J Med 2008;359: 2195-2207


    Jupiter subgroup analysis l.jpg

    JUPITER – Subgroup analysis

    Placebo better

    Rosuvastatin better

    0.8

    0.4

    0.2

    1.2

    0.6

    0

    1

    Hazard ratio (95% CI)

    Ridker P et al. N Eng J Med 2008;359: 2195-2207

    For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


    Jupiter total mortality death from any cause l.jpg

    JUPITER - Total MortalityDeath from any cause

    Hazard Ratio 0.80

    (95% CI 0.67-0.97)

    p=0.02

    7

    Placebo

    6

    5

    Rosuvastatin 20mg

    Percent total mortality

    4

    3

    2

    1

    0

    0

    1

    2

    3

    4

    5

    Years

    Number at risk

    RSV 8901 8787 4312 1602 676 227

    Placebo 8901 8775 4319 1614 681 246

    Ridker P et al. N Eng J Med 2008;359: 2195-2207

    For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


    Slide30 l.jpg

    JUPITER Effects on LDL-C, HDL-C, TG and hsCRP at 12 months;Percentage change between rosuvastatin and placebo

    10

    LDL-C

    HDL-C

    TG

    hsCRP

    4%

    0

    p<0.001*

    -10

    17%

    -20

    Percentage change from baseline (%)

    p<0.001

    -30

    37%

    -40

    p<0.001

    50%

    -50

    p<0.001

    -60

    Ridker P et al. N Eng J Med 2008;359: 2195-2207

    *P-value at study completion (48 months) = 0.34

    For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.


    Jupiter tolerability and safety data l.jpg

    JUPITERTolerability and safety data

    Placebo Rosuvastatin p-value [n=8901][n=8901]

    • Adverse Events, (%)

    • Any serious adverse event15.515.20.60

    • Muscle weakness, stiffness, pain15.416.00.34

    • Myopathy0.1 0.10.82

    • Rhabdomyolysis 0.0 <0.1*----

      • Newly diagnosed cancer3.53.40.51

      • Death from cancer0.70.40.02

      • Gastrointestinal disorders19.219.70.43

      • Renal disorders5.46.00.08

      • Bleeding3.12.90.45

      • Hepatic disorders2.12.40.13

    • Other events, (%)

      • Newly diagnosed diabetes**2.43.00.01

      • Haemorrhagic stroke 0.10.10.44

    *Occurred after trial completion; **physician reported newly diagnosed diabetes

    Ridker P et al. N Eng J Med 2008;359: 2195-2207


    Jupiter laboratory safety data l.jpg

    JUPITERLaboratory Safety Data

    Placebo Rosuvastatin p-value[n=8901][n=8901]

    • Laboratory Values, N (%)

    • Serum creatinine‡ 10 (0.10) 16 (0.20)0.24

      • ALT > 3 x ULN# 17 (0.20) 23 (0.30)0.34

    • Glycosuria† 32 (0.40) 36 (0.50)0.64

    • Laboratory Values, median values (IQR)

    • GFR*, (mL/min/1.73m2) 66.6 (58.8-76.2) 66.8 (59.1-76.5)0.02

    • % HbA1c** 5.8 (5.6-6.1) 5.9 (5.7-6.1)0.001

    • Fasting plasma glucose**, (mg/dL) 98 (90-106) 98 (91-107)0.12

    GFR = Glomerular filtration rate, HbA1c = Haemoglobin A1c

    # on consecutive visits, ‡ >100% increase from baseline,*at 12 months, **at 24 months, †>trace at 12 months

    Ridker P et al. N Eng J Med 2008;359: 2195-2207


    Jupiter summary and perspectives l.jpg

    JUPITER – summary and perspectives

    • The JUPITER study included patients with low to normal LDL-C who were at increased CV risk as identified by elevated CRP levels and who did not require statin treatment based on current treatment guidelines

    • A 44% reduction in the primary endpoint of major cardiovascular events (composite of: CV death, MI, stroke, unstable angina, arterial revascularisation) was observed in patients who received rosuvastatin 20 mg compared with placebo (p< 0.00001)

    • A 20% reduction in total mortality was observed in patients who received rosuvastatin 20 mg compared with placebo (p=0.02), a unique finding for statins in a population without established CHD

    • In JUPITER, long-term treatment with rosuvastatin 20 mg was well tolerated in nearly 9000 study participants

    • There was no difference between treatment groups for muscle weakness, cancer, haematological disorders, gastrointestinal, hepatic or renal systems

    • The results from JUPITER highlight the importance of highly effective statin treatment for these patients with an increased risk of CV disease

    Ridker P et al. N Eng J Med 2008;359: 2195-2207


    Acknowledgements l.jpg

    Acknowledgements

    • The JUPITER Steering Committee

      • P Ridker (Chairman), Boston, MA, USA

      • A Gotto, New York, NY, USA

      • P Libby, Boston, MA, USA

      • J Willerson, Houston, TX, USA

      • J Genest, Montreal, Canada

    • The JUPITER Independent Data Monitoring Board

    • The JUPITER investigators and participating patients

    • This study is supported by AstraZeneca


    Slide35 l.jpg

    DISCLAIMER

    • This slide presentation may include evolving scientific information that has not been reviewed and approved by Health Canada. These slides are intended for educational purposes only.

    • AstraZeneca Canada Inc. does not recommend the use of CRESTOR® in any other indication than as described in the Canadian Product Monograph.

    • INDICATIONS AND CLINICAL USES

    • CRESTOR® (rosuvastatin calcium) is indicated as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol (Total-C), LDL-C, Apo-B, Total-C/HDL-C ratio and triglycerides (TG) and for increasing HDL-C; in hyperlipidemic and dyslipidemic conditions, when response to diet and exercise alone has been inadequate including:

      • Primary hypercholesterolemia (Type IIa including heterozygous familial hypercholesterolemia and severe non-familial hypercholesterolemia)

      • Combined (mixed) dyslipidemia (Type IIb)

      • Homozygous familial hypercholesterolemia where CRESTOR ® is used either alone or as an adjunct to diet and other lipid lowering treatment such as apheresis

    • Rosuvastatin is not indicated for the treatment of patients with high C-Reactive Protein (CRP).


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