Trial Outcomes & Findings for Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024) (NCT NCT00289900)
NCT ID: NCT00289900
Last Updated: 2018-08-31
Results Overview
Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.
COMPLETED
PHASE3
2340 participants
Baseline and Week 12
2018-08-31
Participant Flow
Participant milestones
| Measure |
MK-0524B 2g/20 mg
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
297
|
436
|
298
|
439
|
437
|
433
|
|
Overall Study
Treated
|
297
|
435
|
298
|
439
|
437
|
433
|
|
Overall Study
COMPLETED
|
229
|
316
|
265
|
380
|
392
|
372
|
|
Overall Study
NOT COMPLETED
|
68
|
120
|
33
|
59
|
45
|
61
|
Reasons for withdrawal
| Measure |
MK-0524B 2g/20 mg
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
28
|
40
|
13
|
19
|
20
|
33
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
8
|
8
|
4
|
8
|
|
Overall Study
Participant had flushing
|
18
|
42
|
1
|
2
|
0
|
4
|
|
Overall Study
Other
|
0
|
0
|
0
|
5
|
1
|
0
|
|
Overall Study
Participant moved
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
21
|
8
|
18
|
12
|
11
|
|
Overall Study
Protocol Violation
|
3
|
9
|
2
|
6
|
7
|
4
|
|
Overall Study
site terminated
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Not treated
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Baseline characteristics by cohort
| Measure |
MK-0524B 2g/20 mg
n=297 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=436 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=298 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=439 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=437 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=433 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
Total
n=2340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
54.7 years
STANDARD_DEVIATION 10.5 • n=10 Participants
|
54.7 years
STANDARD_DEVIATION 10.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
248 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
258 Participants
n=10 Participants
|
1309 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
205 Participants
n=21 Participants
|
175 Participants
n=10 Participants
|
1031 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=255 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=361 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=280 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=402 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=410 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=402 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in the LDL-C/HDL-C Ratio
|
-50.9 Percentage Change
Interval -53.8 to -47.9
|
-53.0 Percentage Change
Interval -55.4 to -50.7
|
-37.6 Percentage Change
Interval -40.5 to -34.8
|
-42.4 Percentage Change
Interval -44.5 to -40.0
|
-47.9 Percentage Change
Interval -50.1 to -45.7
|
-48.8 Percentage Change
Interval -51.1 to -46.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=255 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=361 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=280 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=402 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=410 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=402 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in HDL-C
|
26.9 Percentage change
Interval 24.7 to 29.1
|
26.6 Percentage change
Interval 24.8 to 28.4
|
7.0 Percentage change
Interval 4.8 to 9.1
|
5.3 Percentage change
Interval 3.6 to 7.0
|
4.5 Percentage change
Interval 2.8 to 6.2
|
3.6 Percentage change
Interval 1.9 to 5.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=255 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=361 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=280 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=402 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=410 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=402 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Triglycerides (TG)
|
-40.3 Percentage change
Interval -44.2 to -36.5
|
-42.0 Percentage change
Interval -45.7 to -38.4
|
-21.9 Percentage change
Interval -25.0 to -18.8
|
-23.8 Percentage change
Interval -26.5 to -21.2
|
-30.4 Percentage change
Interval -32.8 to -27.9
|
-33.8 Percentage change
Interval -36.4 to -31.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=255 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=361 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=280 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=402 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=410 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=402 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Non-HDL-C
|
-40.4 Percentage change
Interval -42.9 to -37.9
|
-42.2 Percentage change
Interval -44.2 to -40.2
|
-31.3 Percentage change
Interval -33.7 to -28.9
|
-36.8 Percentage change
Interval -38.7 to -34.9
|
-42.6 Percentage change
Interval -44.5 to -40.7
|
-44.6 Percentage change
Interval -46.6 to -42.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=255 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=361 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=280 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=402 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=410 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=402 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in LDL-C
|
-40.4 Percentage change
Interval -43.0 to -37.7
|
-42.8 Percentage change
Interval -44.9 to -40.7
|
-33.6 Percentage change
Interval -36.1 to -31.0
|
-39.8 Percentage change
Interval -41.8 to -37.8
|
-45.6 Percentage change
Interval -47.6 to -43.6
|
-47.5 Percentage change
Interval -49.5 to -45.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=248 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=350 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=272 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=396 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=404 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=389 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein (Apo) B
|
-36.1 Percentage change
Interval -38.4 to -33.7
|
-38.0 Percentage change
Interval -39.9 to -36.2
|
-26.9 Percentage change
Interval -29.2 to -24.6
|
-32.8 Percentage change
Interval -34.6 to -31.0
|
-37.2 Percentage change
Interval -38.9 to -35.4
|
-38.3 Percentage change
Interval -40.1 to -36.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=248 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=350 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=272 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=396 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=404 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=389 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Apo A-I
|
10.7 Percentage change
Interval 8.7 to 12.6
|
8.2 Percentage change
Interval 6.7 to 9.7
|
1.7 Percentage change
Interval -0.2 to 3.5
|
0.4 Percentage change
Interval -1.0 to 1.9
|
-0.8 Percentage change
Interval -2.2 to 0.7
|
-2.5 Percentage change
Interval -3.9 to -1.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=255 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=361 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=280 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=402 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=410 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=402 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Cholesterol (TC)
|
-28.1 Percentage change
Interval -30.1 to -26.2
|
-30.0 Percentage change
Interval -31.5 to -28.4
|
-24.6 Percentage change
Interval -26.4 to -22.7
|
-29.4 Percentage change
Interval -30.9 to -27.9
|
-34.2 Percentage change
Interval -35.7 to -32.7
|
-36.1 Percentage change
Interval -37.6 to -34.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=248 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=350 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=272 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=396 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=404 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=391 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lipoprotein (a) (Lp[a])
|
-15.2 Percentage change
Interval -19.9 to -10.6
|
-14.6 Percentage change
Interval -17.9 to -11.4
|
0.0 Percentage change
Interval -2.9 to 2.9
|
0.0 Percentage change
Interval -3.4 to 3.4
|
7.8 Percentage change
Interval 4.6 to 11.1
|
8.8 Percentage change
Interval 5.5 to 12.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=246 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=351 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=274 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=397 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=406 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=396 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in C-reactive Protein (CRP)
|
-15.4 Percentage change
Interval -23.8 to -7.0
|
-20.0 Percentage change
Interval -27.3 to -12.7
|
-19.5 Percentage change
Interval -26.2 to -12.8
|
-28.6 Percentage change
Interval -34.2 to -22.9
|
-33.3 Percentage change
Interval -38.0 to -28.6
|
-38.1 Percentage change
Interval -43.1 to -33.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.
Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=255 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=361 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=280 Participants
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=402 Participants
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=410 Participants
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=402 Participants
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in TC/HDL-C Ratio
|
-41.0 Percentage change
Interval -43.2 to -38.7
|
-42.3 Percentage change
Interval -44.2 to -40.5
|
-28.2 Percentage change
Interval -30.4 to -26.0
|
-31.5 Percentage change
Interval -33.3 to -29.8
|
-36.0 Percentage change
Interval -37.7 to -34.2
|
-36.7 Percentage change
Interval -38.5 to -35.0
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=701 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1577 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
|
0.4 Percentage of Participants
|
1.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=701 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1577 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN
|
0.1 Percentage of Participants
|
0.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=701 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1577 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN
|
0.0 Percentage of Participants
|
0.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was \>=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=701 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1577 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
|
0.1 Percentage of Participants
|
0.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was \>=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=701 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1577 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
|
0.1 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was \>=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=701 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1577 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
|
0.1 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and normal glycemic status at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=605 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1343 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
|
0.2 Percentage of Participants
|
0.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who had taken at least 1 dose of study medication and did not have diabetes at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities \[MedDRA\] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=703 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1523 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With New Diagnosis of Diabetes
|
0.9 Percentage of Participants
|
0.2 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksPopulation: All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=732 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1607 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
|
0.1 Percentage of Participants
|
0.2 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksPopulation: All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=732 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1607 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
|
59.6 Percentage of Participants
|
45.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=732 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1607 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)
|
5.2 Percentage of Participants
|
5.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=732 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1607 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
|
16.5 Percentage of Participants
|
4.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksPopulation: All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=732 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1607 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
|
0.7 Percentage of Participants
|
0.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksPopulation: All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.
Outcome measures
| Measure |
MK-0524B 2g/20 mg
n=732 Participants
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40mg
n=1607 Participants
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE
|
0.0 Percentage of Participants
|
0.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
Adverse Events
MK-0524B 2g/20 mg
MK-0524B 2g/40 mg
Atorvastatin 10 mg
Atorvastatin 20 mg
Atorvastatin 40 mg
Atorvastatin 80 mg
Serious adverse events
| Measure |
MK-0524B 2g/20 mg
n=297 participants at risk
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40 mg
n=435 participants at risk
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=298 participants at risk
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=439 participants at risk
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=437 participants at risk
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=433 participants at risk
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.23%
1/437 • Number of events 1 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
1/297 • Number of events 1 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
General disorders
Adverse drug reaction
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
General disorders
Chest pain
|
0.34%
1/297 • Number of events 1 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.23%
1/437 • Number of events 1 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
General disorders
Device malfunction
|
0.34%
1/297 • Number of events 1 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
General disorders
Multi-organ failure
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Infections and infestations
Abscess oral
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Infections and infestations
Appendicitis
|
0.34%
1/297 • Number of events 1 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.23%
1/437 • Number of events 1 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.34%
1/298 • Number of events 1 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 2 • up to 14 weeks
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/297 • up to 14 weeks
|
0.23%
1/435 • Number of events 1 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.00%
0/439 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.34%
1/298 • Number of events 1 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.00%
0/298 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/297 • up to 14 weeks
|
0.00%
0/435 • up to 14 weeks
|
0.34%
1/298 • Number of events 1 • up to 14 weeks
|
0.23%
1/439 • Number of events 1 • up to 14 weeks
|
0.00%
0/437 • up to 14 weeks
|
0.00%
0/433 • up to 14 weeks
|
Other adverse events
| Measure |
MK-0524B 2g/20 mg
n=297 participants at risk
Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
|
MK-0524B 2g/40 mg
n=435 participants at risk
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
|
Atorvastatin 10 mg
n=298 participants at risk
Atorvastatin 10 mg, orally, once daily for 12 weeks
|
Atorvastatin 20 mg
n=439 participants at risk
Atorvastatin 20 mg, orally, once daily for 12 weeks
|
Atorvastatin 40 mg
n=437 participants at risk
Atorvastatin 40 mg, orally, once daily for 12 weeks
|
Atorvastatin 80 mg
n=433 participants at risk
Atorvastatin 80 mg, orally, once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
4/297 • Number of events 4 • up to 14 weeks
|
3.0%
13/435 • Number of events 14 • up to 14 weeks
|
5.0%
15/298 • Number of events 16 • up to 14 weeks
|
3.4%
15/439 • Number of events 15 • up to 14 weeks
|
4.1%
18/437 • Number of events 19 • up to 14 weeks
|
3.5%
15/433 • Number of events 18 • up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
16/297 • Number of events 23 • up to 14 weeks
|
6.4%
28/435 • Number of events 33 • up to 14 weeks
|
1.0%
3/298 • Number of events 3 • up to 14 weeks
|
0.68%
3/439 • Number of events 4 • up to 14 weeks
|
0.46%
2/437 • Number of events 2 • up to 14 weeks
|
0.23%
1/433 • Number of events 1 • up to 14 weeks
|
|
Vascular disorders
Flushing
|
19.2%
57/297 • Number of events 67 • up to 14 weeks
|
23.4%
102/435 • Number of events 120 • up to 14 weeks
|
2.3%
7/298 • Number of events 7 • up to 14 weeks
|
2.5%
11/439 • Number of events 13 • up to 14 weeks
|
2.7%
12/437 • Number of events 12 • up to 14 weeks
|
4.4%
19/433 • Number of events 20 • up to 14 weeks
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER