Safety
In this section, you can review the safety profile for CRESTOR® (rosuvastatin calcium). This safety profile is in line with other leading statins, as demonstrated by preapproval clinical trials in 10,275 patients and postmarketing experience.1,9,10,23,24,25,26
For a comprehensive, scientific, nonpromotional summary of rosuvastatin clinical trials conducted by AstraZeneca and a summary of postmarketing data for the first five years that rosuvastatin was available (through April 2008), please visit www.rosuvastatininformation.com.
Safety Evidence
-
Extensive clinical trials and postmarketing experience
-
-
Variety of patient types enrolled in CRESTOR clinical trials9
-
-
Discontinuation rates due to adverse events similar to placebo and other studied statins in fixed-dose controlled trials9
-
-
Incidence of Myalgia and Myopathy with CRESTOR9
-
-
Reported incidence of serum transaminase elevations with CRESTOR and other statins9
-
-
Serum creatinine changes with long-term CRESTOR treatment45
-
-
Estimated glomerular filtration rate (eGFR) with CRESTOR 5 mg to 40 mg45
-
-
Percentage of proteinuria incidence with statin therapies at last visit45
-
-
Urinary albumin excretion (UAE) with CRESTOR46
-
Extensive clinical trials and postmarketing experience
Variety of patient types enrolled in CRESTOR clinical trials*9
Shepherd et al evaluated the safety and tolerability of CRESTOR using data from a multinational phase II/III/IIIb/IV program that included 16,876 patients (25,670 patient-years) who received CRESTOR 5 mg to 40 mg. Data from 33 clinical trials whose databases were locked up to and including September 16, 2005, were used in the analysis. Dose-ranging, fixed-dose, forced-titration, and titration-to-goal trial designs were utilized, as were controlled trials with placebo or comparator statins (atorvastatin 10 mg to 80 mg, simvastatin 10 mg to 80 mg, and pravastatin 10 mg to 40 mg).9
Discontinuation rates due to adverse events similar to placebo and other studied statins in fixed-dose controlled trials9
Shepherd et al evaluated the safety and tolerability of CRESTOR
using data from a multinational phase II/III/IIIb/IV program
that included 16,876 patients (25,670 patient-years) who received
CRESTOR 5 mg to 40 mg. Data from 33 clinical trials whose
databases were locked up to and including September 16, 2005,
were used in the analysis. Dose-ranging, fixed-dose,
forced-titration, and titration-to-goal trial designs were
utilized, as were controlled trials with placebo or comparator
statins (atorvastatin 10 mg to 80 mg, simvastatin 10 mg to 80 mg,
and pravastatin 10 mg to 40 mg). The discontinuation rates due to
adverse events presented above were determined from the fixed-dose
controlled trials.9
Incidence of myalgia and myopathy with CRESTOR9
Shepherd et al evaluated the safety and tolerability of CRESTOR using data from a multinational phase II/III/IIIb/IV program that included 16,876 patients (25,670 patient-years) who received CRESTOR 5 mg to 40 mg. Data from 33 clinical trials whose databases were locked up to and including September 16, 2005, were used in the analysis. Dose-ranging, fixed-dose, forced-titration, and titration-to-goal trial designs were utilized, as were controlled trials with placebo or comparator statins (atorvastatin 10 mg to 80 mg, simvastatin 10 mg to 80 mg, and pravastatin 10 mg to 40 mg).9
Reported incidence of serum transaminase elevations with CRESTOR and other statins*9
Shepherd et al evaluated the safety and tolerability of CRESTOR
using data from a multinational phase II/III/IIIb/IV program
that included 16,876 patients (25,670 patient-years) who
received CRESTOR 5 mg to 40 mg. Data from 33 clinical trials
whose databases were locked up to and including
September 16, 2005, were used in the analysis. Dose-ranging,
fixed-dose, forced-titration, and titration-to-goal trial
designs were utilized, as were controlled trials with placebo
or comparator statins (atorvastatin 10 mg to 80 mg,
simvastatin 10 mg to 80 mg, and pravastatin 10 mg to 40 mg).
Rates of clinically significant ALT elevations were assessed
using data from controlled trials.9
Serum creatinine changes with long-term CRESTOR treatment45
Shepherd et al evaluated the safety and tolerability of CRESTOR
using data from a multinational phase II/III/IIIb/IV program
that included 16,876 patients (25,670 patient-years) who
received CRESTOR 5 mg to 40 mg. Data from 33 clinical trials
whose databases were locked up to and including
September 16, 2005, were used in the analysis. Dose-ranging,
fixed-dose, forced-titration, and titration-to-goal trial
designs were utilized, as were controlled trials with placebo or comparator statins (atorvastatin 10 mg to 80 mg, simvastatin 10 mg to 80 mg, and pravastatin 10 mg to 40 mg). The effects on serum creatinine were assessed using data from the all-controlled/uncontrolled pool.9
Estimated glomerular filtration rate (eGFR) with CRESTOR 5 mg to 40 mg45
Shepherd et al evaluated the safety and tolerability of CRESTOR
using data from a multinational phase II/III/IIIb/IV program
that included 16,876 patients (25,670 patient-years) who
received CRESTOR 5 mg to 40 mg. Data from 33 clinical trials
whose databases were locked up to and including
September 16, 2005, were used in the analysis. Dose-ranging,
fixed-dose, forced-titration, and titration-to-goal trial
designs were utilized, as were controlled trials with placebo
or comparator statins (atorvastatin 10 mg to 80 mg,
simvastatin 10 mg to 80 mg, and pravastatin 10 mg to 40 mg).
The effects on eGFR were assessed using data from the
all-controlled/uncontrolled pool.9
Percentage of proteinuria incidence with statin therapies at last visit45
Shepherd et al evaluated the safety and tolerability of CRESTOR
using data from a multinational phase II/III/IIIb/IV program
that included 16,876 patients (25,670 patient-years) who
received CRESTOR 5 mg to 40 mg. Data from 33 clinical trials
whose databases were locked up to and including
September 16, 2005, were used in the analysis. Dose-ranging,
fixed-dose, forced-titration, and titration-to-goal trial
designs were utilized, as were controlled trials with placebo
or comparator statins (atorvastatin 10 mg to 80 mg,
simvastatin 10 mg to 80 mg, and pravastatin 10 mg to 40 mg).
Rates of proteinuria were assessed using data from the
all-controlled pool.9
Urinary albumin excretion (UAE) with CRESTOR46
SOROF was part of the URANUS study.46
URANUS was a 16-week,
randomized, double-blind, forced-titration trial comparing CRESTOR
and atorvastatin in 465 type 2 diabetics with dyslipidemia.13
Patients were randomized to CRESTOR 10 mg
or atorvastatin 10 mg
for 4 weeks and then titrated up if goal was not met.13
The primary end point, percentage change from baseline in LDL-C at
16 weeks, was significantly better
in the rosuvastatin group
(10 to 40 mg) when compared with the atorvastatin group
(10 to 80 mg).13