A Trial of Lipitor (Atorvastatin) for the Treatment of Po... | NCT00529542

A Trial of Lipitor (Atorvastatin) for the Treatment of Po... | NCT00529542 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Atorvastatin	Experimental		Drug: Lipitor
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Lipitor	Drug	40mg caplets per day for six weeks	Atorvastatin	Atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brachial Artery Flow-mediated Dilation (FMD)	Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.	baseline and 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Peak Brachial Artery Conductance (BAC)	Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5-12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200-250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200-250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.

Measure	Description	Time Frame
High-sensitivity C-reactive Protein (hsCRP)	high sensitive C-reactive protein as a measure of inflammation	baseline and 6 weeks

Contacts/Locations Module

Name	Affiliation	Role
Richard S Legro, MD	Penn State College of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Penn State Milton S Hershey Medical Center, College of Medicine		Hershey	Pennsylvania	17033	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37462232	Derived	Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.
21144505	Derived	Raja-Khan N, Kunselman AR, Hogeman CS, Stetter CM, Demers LM, Legro RS. Effects of atorvastatin on vascular function, inflammation, and androgens in women with polycystic ovary syndrome: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2011 Apr;95(5):1849-52. doi: 10.1016/j.fertnstert.2010.11.040. Epub 2010 Dec 8.

Label	URL
Related Info	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Atorvastatin	Atorvastatin, 40 mg qd
FG001	Placebo	Placebo qd

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Atorvastatin	Atorvastatin, 40 mg qd
BG001	Placebo	Placebo qd
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG00111 BG00220

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0009 BG00111 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0009 BG00111 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Brachial Artery Flow-mediated Dilation (FMD)

Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

% change in brachial artery diameter

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG00111

Title

Denominators

Categories

Before treatment

Title	Measurements
	OG00012.0± 7.3 OG0019.8± 5.8

After treatment

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.	Linear mixed-effects models	Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.	0.58	All hypotheses tests were two-sided.	Mean Difference (Net)	-2.0			2-Sided	95	-9.3	5.3

Secondary

Peak Brachial Artery Conductance (BAC)

Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5-12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200-250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200-250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

ml/sec/mm Hg

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts

Secondary

Total Cholesterol

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mg/dl

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

LDL Cholesterol

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mg/dl

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

HDL Cholesterol

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mg/dl

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

Triglycerides

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mg/dl

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

Fasting Glucose

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mg/dl

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

Fasting Insulin

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

uU/ml

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

Area Under the Curve (AUC) for Glucose During OGTT

A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mg*minute/dL

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG000

Secondary

AUC for Insulin

Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

uU*minute/mL

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG000

Secondary

Total Testosterone

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

ng/dl

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

Androstenedione

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

ng/ml

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Secondary

DHEAS

Dehydroepiandrosterone sulfate

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

ng/ml

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009

Other Pre-specified

High-sensitivity C-reactive Protein (hsCRP)

high sensitive C-reactive protein as a measure of inflammation

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mg/L

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG000

Post-Hoc

Systolic Blood Pressure

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mm Hg

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Post-Hoc

Diastolic Blood Pressure

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mm Hg

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Post-Hoc

Mean Ovarian Volume

Pelvic ultrasound was performed using the 6.5 megahertz (MHz) probe of an ATL 400 machine to characterize ovarian size and morphology. Since in vitro studies demonstrate that statins inhibit ovarian theca-interstitial cell proliferation, we hypothesized that statins might reduce ovarian volume in PCOS.

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

mm3

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG000

Post-Hoc

Body Mass Index

All analyses were performed by intention-to-treat.

Posted

Mean

Standard Deviation

kg/m2

baseline and 6 weeks

ID	Title	Description
OG000	Atorvastatin	Atorvastatin, 40 mg qd
OG001	Placebo	Placebo qd

Units	Counts
Participants	OG0009 OG001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atorvastatin	Atorvastatin, 40 mg qd			1	9	1	9
EG001	Placebo	Placebo qd			0	11	2	11

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
gallbladder removal	Hepatobiliary disorders		Non-systematic Assessment		EG0001 events1 affected9 at risk EG0010 events0 affected11 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
swelling	General disorders	Non-systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected11 at risk
muscle pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected11 at risk
headache	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected11 at risk

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.39		Mean Difference (Net)	0.7			2-Sided	95	-0.9	2.3				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		<0.001		Mean Difference (Net)	-70.8			2-Sided	95	-95.2	-46.4				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		<0.001		Mean Difference (Net)	-57.6			2-Sided	95	-79.3	-35.9				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.26		Mean Difference (Net)	3.4			2-Sided	95	-2.7	9.5				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		<0.001		Mean Difference (Net)	-82.2			2-Sided	95	-126.2	-38.1				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.45		Mean Difference (Net)	-3.3			2-Sided	95	-12.4	5.8				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.33		Mean Difference (Net)	2.5			2-Sided	95	-2.8	7.9				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.61		Mean Difference (Net)	586			2-Sided	95	-1811	2983				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.07		Mean Difference (Net)	3385			2-Sided	95	-287	7056				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.88		Mean Difference (Net)	1.8			2-Sided	95	-24.1	27.8				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		<0.001		Mean Difference (Net)	-1.1			2-Sided	95	-1.6	-0.5				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.02		Mean Difference (Net)	-364.3			2-Sided	95	-655.3	-73.2				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.21		Mean Difference (Net)	-2.4			2-Sided	95	-6.4	1.5				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.27		Mean Difference (Net)	-5.9			2-Sided	95	-16.9	5.0				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.05		Mean Difference (Net)	-7.8			2-Sided	95	-15.8	0.1				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.48		Mean Difference (Net)	3.5			2-Sided	95	-6.8	13.7				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."	Linear mixed-effects models		0.63		Mean Difference (Net)	0.2			2-Sided	95	-0.6	1.0				No	Superiority or Other

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D002241	Carbohydrates