Trial Outcomes & Findings for A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102) (NCT NCT00961636)

Last Updated: 2015-02-16

Results Overview

Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7\*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, \>0 to 0.5, \>0.5 to 1, \>1 to 2, \>2 to 3, and \>3 days per week.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1152 participants

Primary outcome timeframe

Week 21 to Week 32

Results posted on

2015-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	ERN/LRPT One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks	ERN/LRPT Then ERN One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.	Placebo One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
Overall Study STARTED	463	456	233
Overall Study COMPLETED	356	325	201
Overall Study NOT COMPLETED	107	131	32

Reasons for withdrawal

Reasons for withdrawal
Measure	ERN/LRPT One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks	ERN/LRPT Then ERN One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.	Placebo One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
Overall Study Adverse Event	35	54	13
Overall Study Flushing Symptoms	29	46	3
Overall Study Lost to Follow-up	2	3	1
Overall Study Physician Decision	3	1	1
Overall Study Protocol Violation	9	5	1
Overall Study Withdrawal by Subject	29	22	13

Baseline Characteristics

A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ERN/LRPT n=463 Participants One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks	ERN/LRPT Then ERN n=456 Participants One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.	Placebo n=233 Participants One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.	Total n=1152 Participants Total of all reporting groups
Age, Customized < 65 years	334 Participants n=5 Participants	328 Participants n=7 Participants	166 Participants n=5 Participants	828 Participants n=4 Participants
Age, Customized >=65 years	129 Participants n=5 Participants	128 Participants n=7 Participants	67 Participants n=5 Participants	324 Participants n=4 Participants
Sex: Female, Male Female	184 Participants n=5 Participants	144 Participants n=7 Participants	87 Participants n=5 Participants	415 Participants n=4 Participants
Sex: Female, Male Male	279 Participants n=5 Participants	312 Participants n=7 Participants	146 Participants n=5 Participants	737 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 21 to Week 32

Population: Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).

Outcome measures

Outcome measures
Measure	ERN/LRPT n=362 Participants One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks	ERN/LRPT Then ERN n=354 Participants One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.	Placebo n=207 Participants One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period 0 Days per week	291 Participants	181 Participants	188 Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period >0 to ≤ 0.5 Days per week	43 Participants	74 Participants	7 Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period >0.5 to ≤1 Days per week	3 Participants	32 Participants	4 Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period >1.0 to ≤2 Days per week	8 Participants	30 Participants	3 Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period >2 to ≤3 Days per week	1 Participants	17 Participants	1 Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period >3 Days per week	16 Participants	20 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 21 to Week 32

Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.

Outcome measures

Outcome measures
Measure	ERN/LRPT n=362 Participants One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks	ERN/LRPT Then ERN n=354 Participants One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.	Placebo n=207 Participants One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period	71 Participants	173 Participants	19 Participants

Adverse Events

ERN/LRPT

Serious events: 17 serious events

Other events: 136 other events

Deaths: 0 deaths

ERN/LRPT Then ERN

Serious events: 34 serious events

Other events: 162 other events

Deaths: 0 deaths

Placebo

Serious events: 13 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	ERN/LRPT n=461 participants at risk One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks	ERN/LRPT Then ERN n=455 participants at risk One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.	Placebo n=232 participants at risk One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
Infections and infestations Nasopharyngitis	7.2% 33/461 • Number of events 40 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	7.5% 34/455 • Number of events 35 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	4.7% 11/232 • Number of events 12 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.
Nervous system disorders Paraesthesia	5.0% 23/461 • Number of events 53 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	6.2% 28/455 • Number of events 65 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	2.6% 6/232 • Number of events 6 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.
Skin and subcutaneous tissue disorders Pruritis	11.1% 51/461 • Number of events 67 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	14.5% 66/455 • Number of events 116 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	7.3% 17/232 • Number of events 18 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.
Vascular disorders Flushing	11.3% 52/461 • Number of events 77 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	18.7% 85/455 • Number of events 130 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.	3.0% 7/232 • Number of events 7 Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications derived from this study should include input from the investigator(s) and Sponsor personnel. Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. 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.
Publication restrictions are in place

Restriction type: OTHER