Trial Outcomes & Findings for An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME) (NCT NCT00465088)

NCT ID: NCT00465088

Last Updated: 2011-06-13

Results Overview

(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 199 participants
• Primary outcome timeframe: From baseline to Week 12
• Results posted on: 2011-06-13

Participant Flow

Of the 199 subjects randomized, 6 did not receive study drug: 2 withdrew consent, 1 had a protocol violation, and 3 had randomization errors. 193 subjects were treated.

Participant milestones

Measure	Niacin Extended-release Plus Simvastatin Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin 40 mg atorvastatin once daily at bedtime
Overall Study STARTED	114	79
Overall Study COMPLETED	82	70
Overall Study NOT COMPLETED	32	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)

Baseline characteristics by cohort

Measure	Niacin Extended-release Plus Simvastatin n=114 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=79 Participants 40 mg atorvastatin once daily at bedtime	Total n=193 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	93 Participants n=5 Participants	73 Participants n=7 Participants	166 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	6 Participants n=7 Participants	27 Participants n=5 Participants
Age Continuous	55.1 years STANDARD_DEVIATION 12.06 • n=5 Participants	51.5 years STANDARD_DEVIATION 11.12 • n=7 Participants	53.6 years STANDARD_DEVIATION 11.80 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	38 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	41 Participants n=7 Participants	84 Participants n=5 Participants
Region of Enrollment United States	114 participants n=5 Participants	79 participants n=7 Participants	193 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 value was obtained within the Week 12 visit window

(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12	30.1 percent change Interval 25.6 to 34.6	9.4 percent change Interval 4.3 to 14.4

SECONDARY outcome

Timeframe: From baseline to Week 8

Population: All treated subjects whose Week 8 value was obtained within the Week 8 visit window

(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=85 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=72 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in HDL-C From Baseline to Week 8	26.7 percent change Interval 23.1 to 30.2	1.4 percent change Interval -2.7 to 5.4

SECONDARY outcome

Timeframe: From baseline to Week 8

Population: All treated subjects whose Week 8 value was obtained within the Week 8 visit window

(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=85 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in Non-HDL-C From Baseline to Week 8	-45.0 percent change Interval -48.9 to -41.0	-44.3 percent change Interval -48.8 to -39.8

SECONDARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 value was obtained within the Week 12 visit window

(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in Non-HDL-C From Baseline to Week 12	-43.4 percent change Interval -47.7 to -39.0	-43.3 percent change Interval -48.2 to -38.5

SECONDARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 value was obtained within the Week 12 visit window (between 70 days after first dose and not more than 3 days after last dose)

(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12	-43.8 percent change Interval -48.3 to -39.2	-46.0 percent change Interval -51.0 to -40.9

SECONDARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 value was obtained within the Week 12 visit window

(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in Triglycerides From Baseline to Week 12	-44.0 percent change Interval -62.8 to -20.9	-37.0 percent change Interval -47.8 to -18.8

SECONDARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 values were obtained within the Week 12 visit window

(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in LDL-C:HDL-C Ratio	-54.5 percent change Interval -59.1 to -49.8	-50.5 percent change Interval -55.7 to -45.3

SECONDARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 value was obtained within the Week 12 visit window

(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in Total Cholesterol From Baseline to Week 12	-31.3 percent change Interval -34.8 to -27.7	-35.1 percent change Interval -39.1 to -31.1

SECONDARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 values were obtained within the Week 12 visit window

(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in Total Cholesterol:HDL-C Ratio	-45.2 percent change Interval -49.0 to -41.3	-40.3 percent change Interval -44.7 to -36.0

SECONDARY outcome

Timeframe: From baseline to Week 12

Population: All treated subjects whose Week 12 value was obtained within the Week 12 visit window

(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=82 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=70 Participants 40 mg atorvastatin once daily at bedtime
Percent Change in Lipoprotein A From Baseline to Week 12	-15.8 percent change Interval -36.8 to 8.8	16.0 percent change Interval -7.1 to 30.8

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated subjects not meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III goals at baseline with both a baseline and at least 1 postbaseline HDL-C value

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=45 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=47 Participants 40 mg atorvastatin once daily at bedtime
Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12	78 Percentage of subjects	28 Percentage of subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline LDL-C value

For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=67 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=58 Participants 40 mg atorvastatin once daily at bedtime
Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12	78 Percentage of subjects	84 Percentage of subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline triglyceride value

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=52 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=44 Participants 40 mg atorvastatin once daily at bedtime
Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12	79 Percentage of subjects	70 Percentage of subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline value for all 3 lipid parameters

NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.

Outcome measures

Measure	Niacin Extended-release Plus Simvastatin n=79 Participants Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin n=65 Participants 40 mg atorvastatin once daily at bedtime
Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12	65 Percentage of subjects	34 Percentage of subjects

Adverse Events

Niacin Extended-release Plus Simvastatin

Serious events: 2 serious events

Other events: 89 other events

Deaths: 0 deaths

Atorvastatin

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Niacin Extended-release Plus Simvastatin Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin 40 mg atorvastatin once daily at bedtime
Cardiac disorders Coronary artery disease	0.88% 1/114	0.00% 0/79
General disorders Chest pain	0.88% 1/114	1.3% 1/79

Other adverse events

Measure	Niacin Extended-release Plus Simvastatin Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	Atorvastatin 40 mg atorvastatin once daily at bedtime
Gastrointestinal disorders Abdominal distension	0.00% 0/114	2.5% 2/79
Gastrointestinal disorders Constipation	4.4% 5/114	0.00% 0/79
Gastrointestinal disorders Diarrhea	7.9% 9/114	2.5% 2/79
Gastrointestinal disorders Nausea	7.9% 9/114	0.00% 0/79
Gastrointestinal disorders Vomiting	9.6% 11/114	0.00% 0/79
General disorders Edema peripheral	0.00% 0/114	2.5% 2/79
Infections and infestations Nasopharyngitis	1.8% 2/114	2.5% 2/79
Infections and infestations Tooth infection	2.6% 3/114	0.00% 0/79
Injury, poisoning and procedural complications Joint sprain	0.00% 0/114	2.5% 2/79
Investigations Blood creatinine phosphokinase increased	0.00% 0/114	2.5% 2/79
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 2/114	2.5% 2/79
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/114	2.5% 2/79
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/114	2.5% 2/79
Musculoskeletal and connective tissue disorders Myalgia	3.5% 4/114	5.1% 4/79
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 3/114	1.3% 1/79
Musculoskeletal and connective tissue disorders Dizziness	2.6% 3/114	2.5% 2/79
Nervous system disorders Headache	7.9% 9/114	2.5% 2/79
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.88% 1/114	2.5% 2/79
Skin and subcutaneous tissue disorders Pruritus	6.1% 7/114	0.00% 0/79
Vascular disorders Flushing	67.5% 77/114	10.1% 8/79

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to release; Sponsor shall receive up to 180 days for review. Differences shall be resolved in good faith through appropriate scientific debate.
• Publication restrictions are in place

Restriction type: OTHER