In this section, you can review results from comparative clinical trials in which CRESTOR®
(rosuvastatin calcium) was used as an adjunct to diet in African-American and Hispanic-American patients.
Use in African-American Patients
-
LDL-C reductions vs atorvastatin in African-American adults with hyperlipidemia or mixed dyslipidemia
-
-
LDL-C goal attainment (LDL-C <100 mg/dL) vs atorvastatin in high-risk African-American adults with hyperlipidemia or mixed dyslipidemia,
-
-
HDL-C increases vs atorvastatin in African-American adults with hyperlipidemia or mixed dyslipidemia
-
Use in Hispanic-American Patients
-
LDL-C reductions vs atorvastatin in moderate and high-risk Hispanic-American adults
-
-
NCEP ATP III Guideline goal attainment (LDL-C <100 mg/dL) in high-risk Hispanic-American adults,
-
LDL-C reductions vs atorvastatin in African-American adults with hyperlipidemia or mixed dyslipidemia
*P<.01 CRESTOR 10 mg vs atorvastatin 10 mg.
†P=NS CRESTOR 20 mg vs atorvastatin 20 mg.
‡P<.0001 CRESTOR 20 mg vs atorvastatin 20 mg.
Mean baseline LDL-C: 189 mg/dL to 192 mg/dL.
CRESTOR 10 mg n=186
atorvastatin 10 mg n=179
CRESTOR 20 mg n=189
atorvastatin 20 mg n=178
ARIES was a 6-week, randomized, open-label, comparative,
multicenter study. Following a 6-week dietary lead-in period,
self-described African-American adults with hyperlipidemia or mixed dyslipidemia
were randomized to receive either CRESTOR
10 mg or 20 mg or atorvastatin 10 mg or 20 mg for 6 weeks.
Primary end point was change from baseline in LDL-C at week 6.
Other end points at week 6 included achievement of NCEP ATP
III LDL-C goals and percentage change in HDL-C and other lipid
parameters.
LDL-C goal attainment (LDL-C <100 mg/dL) vs atorvastatin in high-risk African-American adults with hyperlipidemia or mixed dyslipidemia,
*P=NS CRESTOR 10 mg vs atorvastatin 10 mg; CRESTOR 10 mg vs atorvastatin 20 mg.
†P<.0001 CRESTOR 20 mg vs atorvastatin 20 mg.
CRESTOR 10 mg n=59
atorvastatin 10 mg n=55
CRESTOR 20 mg n=64
atorvastatin 20 mg n=63
This retrospective analysis of goal attainment was adapted from the ARIES trial.
ARIES was a 6-week, randomized, open-label, comparative,
multicenter study. Following a 6-week dietary lead-in period,
self-described African-American adults with hyperlipidemia or mixed dyslipidemia
were randomized to receive either CRESTOR
10 mg or 20 mg or atorvastatin 10 mg or 20 mg for 6 weeks.
Primary end point was change from baseline in LDL-C at week 6.
Other end points at week 6 included achievement of NCEP ATP
III LDL-C goals and percentage change in HDL-C and other lipid parameters.
HDL-C increases vs atorvastatin in African-American adults with hyperlipidemia or mixed dyslipidemia
*P=NS CRESTOR 10 mg vs atorvastatin 10 mg.; CRESTOR 20 mg vs atorvastatin 20 mg.
†P<.01 CRESTOR 10 mg vs atorvastatin 20 mg.
Mean baseline HDL-C: 50 mg/dL to 53 mg/dL.
CRESTOR 10 mg n=186
atorvastatin 10 mg n=179
CRESTOR 20 mg n=189
atorvastatin 20 mg n=178
ARIES was a 6-week, randomized, open-label, comparative,
multicenter study. Following a 6-week dietary lead-in period,
self-described African-American adults with hyperlipidemia or mixed dyslipidemia
were randomized to receive either CRESTOR
10 mg or 20 mg or atorvastatin 10 mg or 20 mg for 6 weeks.
Primary end point was change from baseline in LDL-C at week 6.
Other end points at week 6 included achievement of NCEP ATP
III LDL-C goals and percentage change in HDL-C and other lipid parameters.
LDL-C reductions vs atorvastatin in moderate and high-risk Hispanic-American adults
*P<.0001 vs atorvastatin 10 mg, NS=CRESTOR 10 mg vs atorvastatin 20 mg.
†P<.0001 vs atorvastatin 20 mg.
Mean baseline LDL-C: 159 mg/dL to 165 mg/dL.
CRESTOR 10 mg n=174
atorvastatin 10 mg n=161
CRESTOR 20 mg n=167
atorvastatin 20 mg n=161
STARSHIP was a 6-week, randomized, open-label, comparative,
multicenter study. Following a 6-week dietary lead-in period,
patients were randomized to 1 of 4 arms: CRESTOR 10 mg or 20 mg
or atorvastatin 10 mg or 20 mg once daily for 6 weeks. Inclusion
criteria for randomization: self-described Hispanic-American adults
(aged ≥18 years) with 10-year CHD risk ≥10%, or CHD or CHD
risk equivalent; LDL-C levels ≥130 mg/dL and ≤300 mg/dL; and
triglyceride levels <400 mg/dL.
The primary end point was the change in LDL-C at 6 weeks.
Other endpoints included achievement
of NCEP ATP III LDL-C goals and percent
changes in other lipid parameters at 6 weeks.
NCEP ATP III Guideline goal attainment (LDL-C <100 mg/dL) in high-risk Hispanic-American adults,
†P=.001 vs atorvastatin 10 mg, NS=CRESTOR 10 mg vs atorvastatin 20 mg.
‡P<.0001 vs atorvastatin 20 mg.
Mean baseline LDL-C: mg/dL to 166 mg/dL.
CRESTOR 10 mg n=116
atorvastatin 10 mg n=106
CRESTOR 20 mg n=106
atorvastatin 20 mg n=106
According to the NCEP ATP III Guidelines, the LDL-C goal for 0 to 1 risk factor is <160 mg/dL, 2+ risk factors (10-year risk <20%) is <130 mg/dL, and CHD or CHD risk equivalents (10-year risk >20%)
is <100 mg/dL.,
This retrospective analysis of goal attainment was adapted from the STARSHIP trial.
This retrospective analysis of goal attainment was adapted from the STARSHIP trial.
STARSHIP was a 6-week, randomized, open-label, comparative,
multicenter study. Following a 6-week dietary lead-in period,
patients were randomized to 1 of 4 arms: CRESTOR 10 mg or 20 mg
or atorvastatin 10 mg or 20 mg once daily for 6 weeks.
Inclusion criteria for randomization: self-described Hispanic-American
adults (aged ≥18 years) with 10-year CHD risk ≥10%, or CHD or
CHD risk equivalent; LDL-C levels ≥130 mg/dL and ≤300 mg/dL;
and triglycerides <400 mg/dL.
The primary end point was the change in LDL-C at 6 weeks.
Other endpoints included achievement
of NCEP ATP III LDL-C goals and percent
changes in other lipid parameters at 6 weeks.