Trial Outcomes & Findings for Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (NCT NCT01785615)

NCT ID: NCT01785615

Last Updated: 2017-06-07

Results Overview

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 116 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-06-07

Participant Flow

Approximately 250 women volunteers were screened and 140 were selected to go on to the first phase of the trial. After a 6-week period of a run in diet phase, 24 did not return to start randomization. Out of 116 women, 6 failed to meet MBS criteria by one ATP III element.

Participant milestones

Measure	Atorvastatin 44 women with metabolic syndrome randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill 44 women with metabolic syndrome randomized to placebo for 6 weeks Placebo : 80mg	Healthy Women Women without metabolic syndrome	Metabolic Syndrome Women These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
Dietary Phase STARTED	0	0	35	140
Dietary Phase COMPLETED	0	0	35	116
Dietary Phase NOT COMPLETED	0	0	0	24
Atorvastatin Phase STARTED	44	44	0	0
Atorvastatin Phase COMPLETED	44	44	0	0
Atorvastatin Phase NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Measure	Atorvastatin 44 women with metabolic syndrome randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill 44 women with metabolic syndrome randomized to placebo for 6 weeks Placebo : 80mg	Healthy Women Women without metabolic syndrome	Metabolic Syndrome Women These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
Dietary Phase Lost to Follow-up	0	0	0	24

Baseline Characteristics

Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin

Baseline characteristics by cohort

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg	Healthy Participants n=35 Participants	Total n=123 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 9 • n=5 Participants	52 years STANDARD_DEVIATION 9 • n=7 Participants	53.7 years STANDARD_DEVIATION 9.0 • n=5 Participants	52.1 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	44 Participants n=7 Participants	35 Participants n=5 Participants	123 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	44 participants n=5 Participants	44 participants n=7 Participants	35 participants n=5 Participants	88 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Low Density Lipoprotein Cholesterol in Blood	70 mg/dl Standard Deviation 24.8	135 mg/dl Standard Deviation 31.4

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Triglycerides in Blood	139 mg/dl Standard Deviation 54.84	185 mg/dl Standard Deviation 65.4

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Apolipoprotein B in Blood	63 mg/dl Standard Deviation 23	110 mg/dl Standard Deviation 23

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood	0.48 ratio Standard Deviation 0.18	0.86 ratio Standard Deviation 0.19

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean High Sensitivity C-reactive Protein in Blood	3095 ng/dl Standard Deviation 1778.8	4027 ng/dl Standard Deviation 1583.8

PRIMARY outcome

Timeframe: 6 weeks

Waist circumference was measured with a ruler tape.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Waist Circumference	41.29 inches Standard Deviation 5.13	42.79 inches Standard Deviation 4.91

PRIMARY outcome

Timeframe: 6 weeks

Measured with a blood pressure cuff

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Systolic Blood Pressure	130.9 mm Hg Standard Deviation 13.03	130.4 mm Hg Standard Deviation 13.30

PRIMARY outcome

Timeframe: 6 weeks

Measured with a blood pressure cuff

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Diastolic Blood Pressure	83.16 mm Hg Standard Deviation 8.67	81.86 mm Hg Standard Deviation 8.14

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean High Density Lipoprotein Cholesterol in Blood	46.4 mg/dl Standard Deviation 8.96	44.2 mg/dl Standard Deviation 9.35

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Fasting Plasma Glucose in Blood	90 mg/dl Standard Deviation 25.2	93 mg/dl Standard Deviation 16.0

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Aspartate Aminotransferase in Blood	20.27 units/L Standard Deviation 5.73	21.09 units/L Standard Deviation 7.12

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Alanine Aminotransferase in Blood	21.59 units/L Standard Deviation 9.10	23.75 units/L Standard Deviation 9.62

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Leptin in Blood	43077 pg/ml Standard Deviation 24706.7	46721.3 pg/ml Standard Deviation 22137.6

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Soluble Intercellular Adhesion Molecule in Blood	192 ng/ml Standard Deviation 64	220 ng/ml Standard Deviation 58

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Soluble Vascular Adhesion Molecule in Blood	512.9 ng/ml Standard Deviation 121.6	534.4 ng/ml Standard Deviation 116.0

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Plasminogen Activator Inhibitor-1 in Blood	6.18 ng/ml Standard Deviation 0.93	6.60 ng/ml Standard Deviation 1.03

PRIMARY outcome

Timeframe: 6 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=44 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=44 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Myeloperoxidase in Blood	52.18 ng/ml Standard Deviation 16.10	59.19 ng/ml Standard Deviation 16.56

SECONDARY outcome

Timeframe: week 0

Waist circumference was measured with a ruler tape.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Waist Circumference	33.3 inches Standard Deviation 5.3	42.6 inches Standard Deviation 5.7

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Low Density Lipoprotein Cholesterol in Blood	119.9 mg/dl Standard Deviation 24.4	133.3 mg/dl Standard Deviation 33.9

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Triglycerides in Blood	94.6 mg/dl Standard Deviation 53.1	197.4 mg/dl Standard Deviation 101.6

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Myeloperoxidase in Blood	43.7 ng/ml Standard Deviation 9.8	52.3 ng/ml Standard Deviation 17.1

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Fasting Blood Glucose in Blood	84.3 mg/dl Standard Deviation 11.4	95.7 mg/dl Standard Deviation 21.4

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean High Density Lipoprotein Cholesterol in Blood	66.6 mg/dl Standard Deviation 9.4	46.3 mg/dl Standard Deviation 10.1

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Intercellular Adhesion Molecule in Blood	179.2 ng/ml Standard Deviation 39.9	212.9 ng/ml Standard Deviation 70.2

SECONDARY outcome

Timeframe: 0 weeks

Measured with a blood pressure cuff

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Systolic Blood Pressure	114.5 mm Hg Standard Deviation 12.6	132.3 mm Hg Standard Deviation 82.9

SECONDARY outcome

Timeframe: 0 weeks

Measured with a blood pressure cuff

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Diastolic Blood Pressure	74.6 mm Hg Standard Deviation 7.1	82.9 mm Hg Standard Deviation 8.3

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Vascular Adhesion Molecule in Blood	614.8 ng/ml Standard Deviation 108.9	525.0 ng/ml Standard Deviation 127.4

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Apolipoprotein A-1 in Blood	172.0 mg/dl Standard Deviation 17.4	134.3 mg/dl Standard Deviation 24.0

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Apolipoprotein B in Blood	86.3 mg/dl Standard Deviation 14.9	107.2 mg/dl Standard Deviation 23.1

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood	0.5 ratio Standard Deviation 0.1	0.8 ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Hs-C Reactive Protein in Blood	1761.5 ng/ml Standard Deviation 1520.4	3586.9 ng/ml Standard Deviation 1531.7

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Leptin in Blood	16285.3 pg/ml Standard Deviation 13317.9	45518.1 pg/ml Standard Deviation 25798.8

SECONDARY outcome

Timeframe: 0 weeks

Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

Outcome measures

Measure	Atorvastatin n=35 Participants 44 women randomized to 80 mg atorvastatin for 6weeks Atorvastatin : 80mg	Sugar Pill n=88 Participants 44 women randomized to placebo for 6 weeks Placebo : 80mg
Mean Plasminogen Activator Inhibitor-1 in Blood	4.5 ng/ml Standard Deviation 0.7	6.2 ng/ml Standard Deviation 1.1

Adverse Events

Atorvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gladys Velarde

University of Florida College of Medicine Jacksonville

Phone: (904)244-2060

Email: Gladys.Velarde@jax.ufl.edu

Results disclosure agreements

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