crestor launch presentation january 2011
DESCRIPTION
pharmTRANSCRIPT
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
Adapted from Jones PH et al. Am J Cardiol 2003;92:152–160
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
PravastatinSimvastatin
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
Adapted from Jones PH et al. Am J Cardiol 2003;92:152–160
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)
RosuvastatinAtorvastatin
PravastatinSimvastatin
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
Adapted from Jones PH et al. Am J Cardiol 2003;92:152–160
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
RosuvastatinAtorvastatin
PravastatinSimvastatin
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
Shepherd J et al. Am J Cardiol 2004;94:882-888
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
Shepherd J et al. Am J Cardiol 2004;94:882-888
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
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