Trial Outcomes & Findings for Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis (NCT NCT01250990)

Results Overview

Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2016-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Niacin Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated. Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.	Placebo Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that. Placebo: Placebo
Overall Study STARTED	11	11
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Niacin n=11 Participants Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated. Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.	Placebo n=11 Participants Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that. Placebo: Placebo	Total n=22 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	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Of the 22 subjects enrolled, only subjects who completed the baseline and 12 week reverse cholesterol transport studies were included in the final outcome analysis.

Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.

Outcome measures

Outcome measures
Measure	Niacin n=7 Participants Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated. Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.	Placebo n=9 Participants Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that. Placebo: Placebo
Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin Pre-treatment	3.24 %/mol/h Interval 2.22 to 4.26	4.16 %/mol/h Interval 3.2 to 5.12
Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin Post-treatment	2.61 %/mol/h Interval 1.59 to 3.63	3.72 %/mol/h Interval 2.76 to 4.67

Adverse Events

Niacin

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Richard L Dunbar

University of Pennsylvania

Phone: 215-662-9024

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place