Trial Outcomes & Findings for ROMEO (Rosuvastatin in Metabolic syndrOme) (NCT NCT00395486)

NCT ID: NCT00395486

Last Updated: 2011-07-11

Results Overview

Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

258 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2011-07-11

Participant Flow

A total of 613 subjects were enrolled in the study at 13 centres, of whom 258 were randomized to treatment with rosuvastatin (n=132) or atorvastatin (n=126). Subjects were recruited throughout South Korea from September 2006 to June 2008.

Enrolled patients to be randomized should complete 6-week dietary run-in periods. Also, LDL level should be ≥ 130mg/dl \& \< 220mg/dl and triglyceride should be \< 500mg/dl.

Participant milestones

Participant milestones
Measure	Rosuvastatin 10mg	Atorvastatin 10mg
Overall Study STARTED	132	126
Overall Study COMPLETED	126	121
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Rosuvastatin 10mg	Atorvastatin 10mg
Overall Study Adverse Event	1	2
Overall Study Withdrawal by Subject	5	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

ROMEO (Rosuvastatin in Metabolic syndrOme)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosuvastatin n=132 Participants 10mg	Atorvastatin n=126 Participants 10mg	Total n=258 Participants Total of all reporting groups
Age Continuous 18 years	57.5 years STANDARD_DEVIATION 10.0 • n=5 Participants	60.4 years STANDARD_DEVIATION 9.0 • n=7 Participants	58.9 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	88 Participants n=7 Participants	162 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	38 Participants n=7 Participants	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6	-44.40 percent change Standard Deviation 14.70	-36.50 percent change Standard Deviation 14.10

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are \<70mg/dl, \<100mg/dl and \<130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk).

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage of Subjects Reaching Their LDL-C Target Goal	88.20 percentage of participants	75.40 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C \& non HDL-C target goal.

Outcome measures

Outcome measures
Measure	Rosuvastatin n=52 Participants 10mg	Atorvastatin n=48 Participants 10mg
Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal	78.80 percentage of participants	66.70 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Using laboratory test, mean change of glucose level was investigated.

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change of Glucose Level	-0.60 Percentage change Standard Deviation 10.10	2.78 Percentage change Standard Deviation 13.90

SECONDARY outcome

Timeframe: Baseline and 6 weeks

HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin\* glucose/22.5

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change of Insulin Resistance Using HOMA-R	28.00 percentage change Standard Deviation 95.20	50.30 percentage change Standard Deviation 287.50

SECONDARY outcome

Timeframe: Baseline and 6 weeks

QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/\[log(insulin) + log(glucose)\].

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change of Insulin Resistance Using QUICKI	-1.27 percentage change Standard Deviation 13.90	-1.03 percentage change Standard Deviation 15.00

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Calculate the percentage reduction of LDL-C

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)	-45.50 percentage reduction Standard Deviation 15.10	-37.90 percentage reduction Standard Deviation 13.40

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Calculate the percentage change of total cholesterol level

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change of Total Cholesterol (TC)	-34.10 percentage change Standard Deviation 11.20	-28.80 percentage change Standard Deviation 10.90

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Calculate the percentage change of HDL-C level

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change of High-Density Lipoprotein-C (HDL-C)	9.90 percentage change Standard Deviation 16.40	8.20 percentage change Standard Deviation 18.70

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Calculate the percentage change of Triglycerides.

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change of Triglycerides (TG)	-17.20 percentage change Standard Deviation 33.90	-15.10 percentage change Standard Deviation 43.50

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Calculate the percentage change of Apolipoprotein A1

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=122 Participants 10mg
Percentage Change of Apolipoprotein A1 (ApoA1)	8.50 percentage change Standard Deviation 12.40	4.20 percentage change Standard Deviation 13.30

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Calculate the percentage change of apolipoprotein B

Outcome measures

Outcome measures
Measure	Rosuvastatin n=127 Participants 10mg	Atorvastatin n=22 Participants 10mg
Percentage Change of Apolipoprotein B (ApoB)	-40.50 percentage change Standard Deviation 14.10	-34.60 percentage change Standard Deviation 13.00

Adverse Events

Rosuvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atorvastatin

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rosuvastatin n=129 participants at risk 10mg	Atorvastatin n=124 participants at risk 10mg
Cardiac disorders Arrhythmia	0.00% 0/129	0.81% 1/124
Gastrointestinal disorders Enteritis	0.00% 0/129	0.81% 1/124
Gastrointestinal disorders Gastroenteritis	0.00% 0/129	0.81% 1/124
Gastrointestinal disorders Haemorrhoids	0.00% 0/129	0.81% 1/124
Nervous system disorders Syncope	0.00% 0/129	0.81% 1/124

Other adverse events

Adverse event data not reported

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60