Trial Outcomes & Findings for Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome (NCT NCT00815659)

Results Overview

HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

97 participants

Primary outcome timeframe

Baseline

Results posted on

2011-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Crestor Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Overall Study STARTED	97
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Crestor Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Overall Study Adverse Event	9
Overall Study Withdrawal by Subject	9
Overall Study Lost to Follow-up	4
Overall Study Protocol Violation	1

Baseline Characteristics

Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Age Continuous	50.9 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal HDL-cholesterol Level	39.5 mg/dL Standard Deviation 6.5

PRIMARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) HDL levels of participants

HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment	43.4 mg/dL Standard Deviation 9.8

PRIMARY outcome

Timeframe: Baseline

Population: Baseline LDL levels of participants

LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal LDL-cholesterol Level	165.5 mg/dL Standard Deviation 32.0

PRIMARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) LDL levels of participants

LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment	98.3 mg/dL Standard Deviation 44.8

PRIMARY outcome

Timeframe: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

Population: Baseline total cholesterol levels of participants

Baseline

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Total Cholesterol Level	236.5 mg/dL Standard Deviation 38.2

PRIMARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) total cholesterol levels of participants

Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment	166.2 mg/dL Standard Deviation 47.7

PRIMARY outcome

Timeframe: Baseline

Population: Baseline triglyceride levels of participants

Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Triglyceride Level	195.1 mg/dL Standard Deviation 65.3

PRIMARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) triglyceride levels of participants

Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Triglyceride Level After 3 Months of Rosuvastatin Treatment	153.1 mg/dL Standard Deviation 76.8

PRIMARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LDL cholesterol levels \< 100 mg/dL, calculated over patients with lipid measurement performed at both visits

Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \<100 mg/dL; HDL-cholesterol: For males \>40 mg/dL, for females \>50 mg/dL; non-HDL-cholesterol: \<130 mg/dL

Outcome measures

Outcome measures
Measure	Crestor n=65 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment	48 Participants

PRIMARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: HDL cholesterol target levels for males \>40 mg/dL, for females \> 50 mg/dL, calculated over patients with lipid measurement performed at both visits

Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment

Outcome measures

Outcome measures
Measure	Crestor n=66 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment	39 Participants

PRIMARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: Non-HDL cholesterol target levels \<130 mg/dL, calculated over patients with lipid measurement performed at both visits

Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment

Outcome measures

Outcome measures
Measure	Crestor n=66 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment	51 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Baseline IL-1 levels of participants

IL-1 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Interleukin 1 (IL-1) Level	4.1 pg/mL Standard Deviation 2.3

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) IL-1 levels of participants

IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment	4.1 pg/mL Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline

Population: Baseline IL-6 levels of participants

IL-6 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Interleukin 6 (IL-6) Level	2.6 pg/mL Standard Deviation 2.1

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) IL-6 levels of participants

IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment	2.8 pg/mL Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline

Population: Baseline IL-8 levels of participants

IL-8 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Interleukin 8 (IL-8) Level	10.7 pg/mL Standard Deviation 5.1

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) IL-8 levels of participants

IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment	12.7 pg/mL Standard Deviation 13.3

SECONDARY outcome

Timeframe: Baseline

Population: Baseline IL-10 levels of participants

IL-10 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Interleukin 10 (IL-10) Level	4.2 pg/mL Standard Deviation 2.1

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) IL-10 levels of participants

IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment	4.8 pg/mL Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline

Population: Baseline Basal Tumor Necrosis Factor (TNF) levels of participants

TNF levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Tumor Necrosis Factor (TNF) Level	10.8 pg/mL Standard Deviation 5.3

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants

TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment	12.9 pg/mL Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline

Population: Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants

hs-CRP levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level	8.2 mg/mL Standard Deviation 7.3

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants

hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment	6.7 mg/mL Standard Deviation 5.6

SECONDARY outcome

Timeframe: Baseline

Population: Baseline LDL-3 levels of participants

LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal LDL-3 Level	15.5 mg/mL Standard Deviation 9.5

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) LDL-3 levels of participants

LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
LDL-3 Level After 3 Months of Rosuvastatin Treatment	8.8 mg/mL Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline

Population: Baseline LDL-4 levels of participants

LDL-4 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal LDL-4 Level	7.9 mg/mL Standard Deviation 9.6

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF(Last Observation Carried Forward) LDL-4 levels of participants

LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
LDL-4 Level After 3 Months of Rosuvastatin Treatment	3.5 mg/mL Standard Deviation 4.8

SECONDARY outcome

Timeframe: Baseline

Population: Baseline LDL-5 levels of participants

LDL-5 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal LDL-5 Level	2.7 mg/mL Standard Deviation 7.1

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) LDL-5 levels of participants

LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
LDL-5 Level After 3 Months of Rosuvastatin Treatment	1.3 mg/mL Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline

Population: Baseline LDL-6 levels of participants

LDL-6 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal LDL-6 Level	0.5 mg/mL Standard Deviation 2.6

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) LDL-6 levels of participants

LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
LDL-6 Level After 3 Months of Rosuvastatin Treatment	0.3 mg/mL Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline

Population: Baseline LDL-7 levels of participants

LDL-7 levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal LDL-7 Level	0.5 mg/mL Standard Deviation 3.0

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) LDL-7 levels of participants

LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
LDL-7 Level After 3 Months of Rosuvastatin Treatment	0.8 mg/mL Standard Deviation 5.3

SECONDARY outcome

Timeframe: Baseline

Population: Baseline Large HDL subfraction of participants

Large HDL subfraction levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Large HDL Subfraction Level	15.0 mg/mL Standard Deviation 6.4

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants

Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	17.6 mg/mL Standard Deviation 7.6

SECONDARY outcome

Timeframe: Baseline

Population: Baseline Intermediate HDL subfraction of participants

Intermediate HDL subfraction levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Intermediate HDL Subfraction Level	18.9 mg/mL Standard Deviation 5.7

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants

Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	19.9 mg/mL Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline

Population: Baseline Small HDL subfraction of participants

Small HDL subfraction levels before (Visit 2-enrollment)

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Basal Small HDL Subfraction Level	6.2 mg/mL Standard Deviation 4.2

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants

Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Outcome measures

Outcome measures
Measure	Crestor n=96 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	6.6 mg/mL Standard Deviation 4.6

SECONDARY outcome

Timeframe: 3 months (from enrollment to last visit)

Population: Number of patients with any adverse events in 3 months

Number of patients with any adverse events in 3 months of rosuvastatin treatment

Outcome measures

Outcome measures
Measure	Crestor n=97 Participants Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Number of Patients With Adverse Events	24 Participants

Adverse Events

Crestor

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Crestor n=97 participants at risk Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Musculoskeletal and connective tissue disorders Myalgia	2.1% 2/97
Investigations CK Increased	2.1% 2/97
Infections and infestations Dysuria	2.1% 2/97
Skin and subcutaneous tissue disorders Pruritus-Allergy-Rash	5.2% 5/97
Gastrointestinal disorders Nausea	1.0% 1/97
Gastrointestinal disorders Allergy	1.0% 1/97
Skin and subcutaneous tissue disorders Dermatoid	1.0% 1/97
Eye disorders Eye Twitching	1.0% 1/97
Eye disorders Blood Pressure Increased	1.0% 1/97
Eye disorders Weight Increased	1.0% 1/97
Musculoskeletal and connective tissue disorders Leg Cramp	1.0% 1/97
Musculoskeletal and connective tissue disorders Leg Swelling	1.0% 1/97
Respiratory, thoracic and mediastinal disorders Cough-Dry Throat	1.0% 1/97
Infections and infestations Upper Respiratory Tract Infection	2.1% 2/97
Infections and infestations Liver Function Tests Abnormal	2.1% 2/97
Skin and subcutaneous tissue disorders Headache	4.1% 4/97
Infections and infestations Acute Pneumonia	1.0% 1/97

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER