Trial Outcomes & Findings for Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects (NCT NCT00874757)

Results Overview

Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

Before and after three weeks of treatment with rosuvastatin

Results posted on

2024-08-23

Participant Flow

A total of 20 subjects were consented between 11/15/2010 and on 8/4/2011.

Participant milestones

Participant milestones
Measure	Rosuvastatin 20 subjects were consented to receive rosuvastatin 20 mg tablets orally every day for three weeks. 16 of the 20 received study drug with four being excluded due to baseline laboratory abnormalities.
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Rosuvastatin 20 subjects were consented to receive rosuvastatin 20 mg tablets orally every day for three weeks. 16 of the 20 received study drug with four being excluded due to baseline laboratory abnormalities.
Overall Study Baseline laboratories outside of normal limits (screen fails).	4

Baseline Characteristics

Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosuvastatin n=16 Participants Single arm non-therapeutic study where all subjects who ruled in for study participation (based on baseline laboratories and clinical assessment) received rosuvastatin 20 mg tablets for three weeks. Inflammatory markers Toll-like Receptor 4, tumor necrosis factor, Interleukin 6, Interleukin 8 (tlr-4, TNF, IL-6, IL-8) were measured at baseline prior to rosuvastatin administration and after treatment to compare the effect of rosuvastatin on inflammatory markers. The primary outcome was the %tlr positive monocytes.
Age, Continuous	27 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before and after three weeks of treatment with rosuvastatin

Population: A total of 16 healthy subjects who met inclusion/exclusion criteria

Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.

Outcome measures

Outcome measures
Measure	Pre-treatment Tlr-4 Expression n=16 Participants Whole blood collected analyzed by flow cytometry prior to the start of rosuvastatin	Post-treatment Trl-4 Monocyte Expression n=16 Participants Flow cytometry performed on blood after 3 weeks of treatment with rosuvastatin
Toll-like Receptor 4 Expression Pre- and Post-Treatment	12.37 % tlr expression (monocytes) Standard Deviation 9.8	6.36 % tlr expression (monocytes) Standard Deviation 4.8

SECONDARY outcome

Timeframe: Pre and post 3 weeks of rosuvastatin treatment

Inflammatory cytokine generated after treatment of whole blood collected before and after rosuvastatin treatment

Outcome measures

Outcome measures
Measure	Pre-treatment Tlr-4 Expression n=16 Participants Whole blood collected analyzed by flow cytometry prior to the start of rosuvastatin	Post-treatment Trl-4 Monocyte Expression n=16 Participants Flow cytometry performed on blood after 3 weeks of treatment with rosuvastatin
Tumor Necrosis Factor (TNF)	145 pg/ml Standard Deviation 52	92 pg/ml Standard Deviation 25

SECONDARY outcome

Timeframe: Before (baseline) and after 3 weeks of rosuvastatin treatment

Interleukin-6 inflammatory cytokine which will be released after LPS treatment of blood

Outcome measures

Outcome measures
Measure	Pre-treatment Tlr-4 Expression n=16 Participants Whole blood collected analyzed by flow cytometry prior to the start of rosuvastatin	Post-treatment Trl-4 Monocyte Expression n=16 Participants Flow cytometry performed on blood after 3 weeks of treatment with rosuvastatin
Interleukin-6	4.8 pg/ml Standard Deviation 1.3	4.1 pg/ml Standard Deviation 1.0

SECONDARY outcome

Timeframe: measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment

Population: 16 subjects that met the inclusion/exclusion criteria the pre-post analysis allowed the use of paired T-test

Interleukin-8 an inflammatory cytokine which will be releases after LPS treatment.

Outcome measures

Outcome measures
Measure	Pre-treatment Tlr-4 Expression n=16 Participants Whole blood collected analyzed by flow cytometry prior to the start of rosuvastatin	Post-treatment Trl-4 Monocyte Expression n=16 Participants Flow cytometry performed on blood after 3 weeks of treatment with rosuvastatin
Interleukin-8	155 pg/ml Standard Deviation 45	125 pg/ml Standard Deviation 27

Adverse Events

Rosuvastatin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rosuvastatin n=16 participants at risk Single arm non-therapeutic study
Musculoskeletal and connective tissue disorders Muscle pain	6.2% 1/16 • Number of events 1 • Collected over 3 weeks for each subject
General disorders insomnia	6.2% 1/16 • Number of events 1 • Collected over 3 weeks for each subject

Additional Information

Timothy R McGuire

University of Nebraska Medical Center

Phone: 402-651-2496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place