Trial Outcomes & Findings for Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg (NCT NCT00427960)

NCT ID: NCT00427960

Last Updated: 2010-12-16

Results Overview

Calculated as LDL-C at Week 6 - LDL-C at Week 12\] \* 100

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: 6 weeks (baseline) and 12 weeks
• Results posted on: 2010-12-16

Participant Flow

Participants were recruited from 25 primary and secondary care centres in the United Kingdom. The first participant was enrolled on 20th December 2006 and the last participant entered the study on 16th November 2007.

Participants entered an initial 6-week dietary run-in/ wash-out period, after which those with a fasting low density lipoprotein cholesterol (LDL-C) of greater than or equal to 4.00 mmol/L and triglycerides (TG) less than 4.52 mmol/L, were randomised to receive treatment with either rosuvastatin 5 mg plus atorvatstatin , or atorvastatin 10mg

Participant milestones

Measure	Rosuvastatin rosuvastatin 5 mg	Atorvastatin atorvastatin 10 mg
Overall Study STARTED	30	25
Overall Study COMPLETED	28	21
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Rosuvastatin rosuvastatin 5 mg	Atorvastatin atorvastatin 10 mg
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	0	3
Overall Study Other	0	1

Baseline Characteristics

Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg

Baseline characteristics by cohort

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg	Total n=55 Participants Total of all reporting groups
Age Continuous	50 years STANDARD_DEVIATION 11 • n=5 Participants	53 years STANDARD_DEVIATION 11 • n=7 Participants	51.5 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24.0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31.0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)	33.28 Percent Change in LDL-C	36.92 Percent Change in LDL-C

SECONDARY outcome

Timeframe: 6 weeks (Baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L	50 Percentage of Participants	64 Percentage of Participants

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L	16 Percentage of Participants	28 Percentage of Participants

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Risk categories are:

Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L

Patients are defined as symptomatic if they meet at least 1 of the following criteria:

History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg

Total risk is derived from age, sex, TC, systolic BP and smoking status.

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.	43 Percentage of Participants	48 Percentage of Participants

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline(week6) in TC	-23.03 Percent Change in TC	-26.88 Percent Change in TC

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)	4.46 Percent Change in HDL-C	3.15 Percent Change in HDL-C

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L	13 Percentage of Participants	12 Percentage of Participants

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline (Week 6)in Non-HDL-C	-29.72 Percent Change in Non-HDL-C	-34.09 Percent Change in Non-HDL-C

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)	-25.96 Percent Change in ApoB	-28.67 Percent Change in ApoB

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)	-0.55 Percent Change in ApoA1	1.89 Percent Change in ApoA1

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio	-34.75 Percent Change in LDL-C/HDL-C Ratio	-38.45 Percent Change in LDL-C/HDL-C Ratio

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio	-24.99 Percent Change in TC/HDL-C Ratio	-28.42 Percent Change in TC/HDL-C Ratio

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio	-31.05 Percent Change in Non-HDL-C/HDL-C Ratio	-35.48 Percent Change in Non-HDL-C/HDL-C Ratio

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio	-22.89 Percent Change in ApoB/ApoA1 Ratio	-28.75 Percent Change in ApoB/ApoA1 Ratio

SECONDARY outcome

Timeframe: 6 weeks (baseline) and 12 weeks

Population: Intention to treat (ITT) population (all randomized patients).

Risk categories are:

Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L

Patients are defined as symptomatic if they meet at least 1 of the following criteria:

History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg

Total risk is derived from age, sex, TC, systolic BP and smoking status.

Outcome measures

Measure	Rosuvastatin n=30 Participants rosuvastatin 5 mg	Atorvastatin n=25 Participants atorvastatin 10 mg
The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.	56.7 Percentage of Participants	56.0 Percentage of Participants

Adverse Events

Rosuvastatin

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Atorvastatin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rosuvastatin rosuvastatin 5 mg	Atorvastatin atorvastatin 10 mg
Nervous system disorders Cerebrovascular Accident	3.3% 1/30	0.00% 0/30

Other adverse events

Measure	Rosuvastatin rosuvastatin 5 mg	Atorvastatin atorvastatin 10 mg
Nervous system disorders Dizziness	10.0% 3/30	4.0% 1/25
Nervous system disorders Headache	3.3% 1/30	8.0% 2/25

Additional Information

Gerard Lynch

Astrazeneca

Email: AZTrial_Results_Posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER