Trial Outcomes & Findings for Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells (NCT NCT00166036)

Results Overview

Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Baseline &12 Weeks

Results posted on

2014-09-08

Participant Flow

Previous statin or other lipid lowering medications will be discontinued for 2 months. Subjects will be on stable medical therapy for at least 2 months before recruitment.

Participant milestones

Participant milestones
Measure	Atorvastatin 10 mg Once Daily for 12 Weeks	Pravastatin 80 mg Once Daily for 12 Weeks
Overall Study STARTED	17	19
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atorvastatin 10 mg n=17 Participants Subject treated with oral Atorvastatin 10 mg for 12 Weeks.	Pravastatin 80 mg n=19 Participants Subject treated with oral Pravastatin 80 mg for 12 Weeks.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	54.2 years STANDARD_DEVIATION 6.6 • n=5 Participants	51.7 years STANDARD_DEVIATION 10.8 • n=7 Participants	52.9 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	09 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	08 Participants n=5 Participants	05 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline &12 Weeks

Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.

Outcome measures

Outcome measures
Measure	Atorvastatin 10 mg n=17 Participants Atorvastatin 10 mg taken daily	Pravastatin 80 mg n=19 Participants Pravastatin 80 mg daily
Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels	2.1 nmol/mL Standard Error 0.8	2.5 nmol/mL Standard Error 1.0

SECONDARY outcome

Timeframe: Baseline & 12 Weeks

Flow-mediated dilatation (FMD) of the brachial artery was used to asses Endothelial Function. The endothelium, by releasing nitric oxide (NO), promotes vasodilation and inhibits inflammation, thrombosis, and vascular smooth muscle cell proliferation.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.

Outcome measures

Outcome measures
Measure	Atorvastatin 10 mg n=17 Participants Atorvastatin 10 mg taken daily	Pravastatin 80 mg n=19 Participants Pravastatin 80 mg daily
Change in Flow-mediated Dilatation (FMD)	5.9 Percentage of brachial artery diameter Standard Error 2.9	6.0 Percentage of brachial artery diameter Standard Error 2.3

Adverse Events

Atorvastatin 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pravastatin 80 mg

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

Arshed A Quyyumi, MD

Emory University

Phone: 404 712 2741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place