Trial Outcomes & Findings for Inflammation and Vascular Function in Atherosclerosis (NCT NCT00760019)

Results Overview

Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

58 participants

Primary outcome timeframe

Upon completion of 4 weeks of salsalate and placebo treatment

Results posted on

2017-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Atherosclerosis/Metabolic Syndrome: Salsalate First, Then Plac Subjects with either Metabolic Syndrome/Atherosclerosis received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.	Atherosclerosis/Metabolic Syndrome: Placebo First, Then Salsal Subjects with either Metabolic Syndrome/Atherosclerosis received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.	Healthy Subjects: Salsalate First, Then Placebo Healthy subjects received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.	Healthy Subjects: Placebo First, Then Salsalate Healthy subjects received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
Overall Study STARTED	15	15	14	14
Overall Study COMPLETED	15	15	14	14
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inflammation and Vascular Function in Atherosclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atherosclerosis or Metabolic Syndrome n=30 Participants Participant flow is identical to that of NCT00762827 ("The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome"): The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this arm, individuals with either Metabolic Syndrome or Atherosclerosis received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks.	Healthy n=28 Participants Participant flow is identical to that of NCT00762827 ("The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome"): The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this control arm, healthy individuals received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks.	Total n=58 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 9 • n=93 Participants	52 years STANDARD_DEVIATION 13 • n=4 Participants	56 years STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	12 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	16 Participants n=4 Participants	38 Participants n=27 Participants

PRIMARY outcome

Timeframe: Upon completion of 4 weeks of salsalate and placebo treatment

Population: The ultrasound data for two subjects was inadequate for analysis. This determination was made prior to unblinding. The data for these two subjects were discarded, leaving 56 subjects for analysis.

Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.

Outcome measures

Outcome measures
Measure	Salsalate n=56 Participants Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.	Placebo n=56 Participants Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
Flow-mediated, Endothelium-dependent Vasodilation	6.8 percentage vasodilation Interval 5.2 to 12.0	8.7 percentage vasodilation Interval 5.4 to 13.5

Adverse Events

Salsalate

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Salsalate n=58 participants at risk Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Salsalate	Placebo n=58 participants at risk Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Placebo
Ear and labyrinth disorders Tinnitus	10.3% 6/58 • Number of events 6	0.00% 0/58

Additional Information

Dr. Joshua Beckman

Brigham and Women's Hospital

Phone: 617-732-6186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place