Trial Outcomes & Findings for Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia (NCT NCT00626392)
NCT ID: NCT00626392
Last Updated: 2009-09-02
Results Overview
The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
COMPLETED
PHASE3
277 participants
From Baseline to end of Week 1
2009-09-02
Participant Flow
Participants were enrolled at 47 study sites in the United States between February and April, 2008.
This study had a 1-week run-in (acetylsalicylic acid \[ASA\] 325 mg or ASA placebo \[Pbo\] once daily) prior to 4 weeks of niacin extended-release (NER) plus ASA/ASA Pbo coadministration. Ten of 277 randomized subjects discontinued before run-in due to withdrawal of consent (4), lost to follow-up (4), protocol violation (1), and other (1).
Participant milestones
| Measure |
NER 500; ASA run-in, ASA Coadmin
Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 500; ASA Pbo run-in, ASA Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 500; ASA Pbo run-in, ASA Pbo Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA run-in; ASA Coadmin
Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA Pbo run-in, ASA Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA Pbo run-in, ASA Pbo Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
|---|---|---|---|---|---|---|
|
Run-in Period
STARTED
|
45
|
44
|
44
|
44
|
45
|
45
|
|
Run-in Period
COMPLETED
|
44
|
43
|
41
|
43
|
41
|
44
|
|
Run-in Period
NOT COMPLETED
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Coadministration Period
STARTED
|
44
|
43
|
41
|
43
|
41
|
44
|
|
Coadministration Period
COMPLETED
|
40
|
38
|
31
|
36
|
36
|
38
|
|
Coadministration Period
NOT COMPLETED
|
4
|
5
|
10
|
7
|
5
|
6
|
Reasons for withdrawal
| Measure |
NER 500; ASA run-in, ASA Coadmin
Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 500; ASA Pbo run-in, ASA Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 500; ASA Pbo run-in, ASA Pbo Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA run-in; ASA Coadmin
Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA Pbo run-in, ASA Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA Pbo run-in, ASA Pbo Coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
|---|---|---|---|---|---|---|
|
Run-in Period
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Run-in Period
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
3
|
1
|
|
Run-in Period
Noncompliance
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Coadministration Period
Adverse Event
|
3
|
1
|
7
|
4
|
3
|
4
|
|
Coadministration Period
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
0
|
1
|
|
Coadministration Period
Protocol Violation
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Coadministration Period
Other
|
0
|
2
|
3
|
1
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Baseline characteristics by cohort
| Measure |
NER 500; ASA run-in, ASA Coadmin
n=44 Participants
Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 500; ASA Pbo run-in, ASA Coadmin
n=43 Participants
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 500; ASA Pbo run-in, ASA Pbo Coadmin
n=41 Participants
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA run-in, ASA Coadmin
n=43 Participants
Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA Pbo run-in, ASA Coadmin
n=41 Participants
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
NER 1000; ASA Pbo run-in, ASA Pbo Coadmin
n=44 Participants
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration (4 weeks)
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
55.5 Years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
49.0 Years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
51.5 Years
STANDARD_DEVIATION 12.58 • n=5 Participants
|
53.7 Years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
54.8 Years
STANDARD_DEVIATION 11.08 • n=21 Participants
|
52.3 Years
STANDARD_DEVIATION 12.45 • n=10 Participants
|
52.8 Years
STANDARD_DEVIATION 11.73 • n=115 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
124.0 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
132.0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
43 participants
n=7 Participants
|
41 participants
n=5 Participants
|
43 participants
n=4 Participants
|
41 participants
n=21 Participants
|
44 participants
n=10 Participants
|
256.0 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From Baseline to end of Week 1Population: All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).
The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
Outcome measures
| Measure |
Any Acetylsalicylic Acid
n=167 Participants
Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
|
No Acetylsalicylic Acid
n=84 Participants
Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
|
|---|---|---|
|
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
None
|
57 Percentage of Subjects
|
48 Percentage of Subjects
|
|
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
Mild
|
28 Percentage of Subjects
|
24 Percentage of Subjects
|
|
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
None/mild
|
85 Percentage of Subjects
|
71 Percentage of Subjects
|
|
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
Moderate
|
11 Percentage of Subjects
|
17 Percentage of Subjects
|
|
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
Severe
|
4 Percentage of Subjects
|
8 Percentage of Subjects
|
|
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
Very severe
|
1 Percentage of Subjects
|
4 Percentage of Subjects
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).
The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
Outcome measures
| Measure |
Any Acetylsalicylic Acid
n=167 Participants
Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
|
No Acetylsalicylic Acid
n=84 Participants
Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
|
|---|---|---|
|
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
None
|
30 Percentage of Subjects
|
15 Percentage of Subjects
|
|
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Mild
|
28 Percentage of Subjects
|
14 Percentage of Subjects
|
|
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
None/Mild
|
58 Percentage of Subjects
|
30 Percentage of Subjects
|
|
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Moderate
|
28 Percentage of Subjects
|
35 Percentage of Subjects
|
|
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Severe
|
11 Percentage of Subjects
|
23 Percentage of Subjects
|
|
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Very severe
|
4 Percentage of Subjects
|
13 Percentage of Subjects
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).
Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.
Outcome measures
| Measure |
Any Acetylsalicylic Acid
n=167 Participants
Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
|
No Acetylsalicylic Acid
n=84 Participants
Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
|
|---|---|---|
|
Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
|
3.1 Scores on a Scale
Standard Deviation 2.86
|
5.1 Scores on a Scale
Standard Deviation 3.16
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).
Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.
Outcome measures
| Measure |
Any Acetylsalicylic Acid
n=167 Participants
Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
|
No Acetylsalicylic Acid
n=84 Participants
Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
|
|---|---|---|
|
Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
|
0.3 Number of Events per Subject per Week
Standard Deviation 0.64
|
0.8 Number of Events per Subject per Week
Standard Deviation 1.10
|
Adverse Events
Any Acetylsalicylic Acid
No Acetylsalicylic Acid
Serious adverse events
| Measure |
Any Acetylsalicylic Acid
Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
|
No Acetylsalicylic Acid
Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
|
|---|---|---|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/171
|
1.2%
1/85 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.58%
1/171 • Number of events 1
|
0.00%
0/85
|
Other adverse events
| Measure |
Any Acetylsalicylic Acid
Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
|
No Acetylsalicylic Acid
Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.3%
4/171
|
1.2%
1/85
|
|
General disorders
Non-cardiac chest pain
|
0.58%
1/171
|
2.4%
2/85
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/171
|
2.4%
2/85
|
|
Investigations
Blood uric acid increased
|
0.00%
0/171
|
2.4%
2/85
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.58%
1/171
|
3.5%
3/85
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/171
|
2.4%
2/85
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
3/171
|
2.4%
2/85
|
|
Vascular disorders
Flushing
|
68.4%
117/171
|
83.5%
71/85
|
Additional Information
Medical Information Specialist
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee Provide Abbott at least sixty (60) days prior to submission for review, Abbott shall return comments within sixty (60) days of receipt of draft. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period.
- Publication restrictions are in place
Restriction type: OTHER