Trial Outcomes & Findings for A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction (NCT NCT00203476)

NCT ID: NCT00203476

Last Updated: 2014-08-12

Results Overview

Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-08-12

Participant Flow

Patients were recruited from 2005-2007 from primary care medical clinics.

Patients had to be on max tolerated dose of a statin and need additional LDL lowering.

Participant milestones

Measure	Niacin Niacin added to max tolerated dose of statin	Colestipol Colestipol added to max dose statin	Ezetimibe Ezetimibe added to max tolerated dose statin
Overall Study STARTED	10	10	10
Overall Study COMPLETED	9	9	10
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Measure	Niacin Niacin added to max tolerated dose of statin	Colestipol Colestipol added to max dose statin	Ezetimibe Ezetimibe added to max tolerated dose statin
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction

Baseline characteristics by cohort

Measure	Niacin n=10 Participants Niacin added to max tolerated dose of statin	Colestipol n=10 Participants Colestipol added to max dose statin	Ezetimibe n=10 Participants Ezetimibe added to max tolerated dose statin	Total n=30 Participants Total of all reporting groups
Age, Customized Age =>50	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: intention to treat

Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.

Outcome measures

Measure	Niacin n=9 Participants Niacin added to max tolerated dose of statin	Colestipol n=9 Participants Colestipol added to max dose statin	Ezetimibe n=10 Participants Ezetimibe added to max tolerated dose statin
LDL Goal Attainment	6 participants	6 participants	9 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Niacin n=9 Participants Niacin added to max tolerated dose of statin	Colestipol n=9 Participants Colestipol added to max dose statin	Ezetimibe n=10 Participants Ezetimibe added to max tolerated dose statin
LFT Elevation	1 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Niacin n=9 Participants Niacin added to max tolerated dose of statin	Colestipol n=9 Participants Colestipol added to max dose statin	Ezetimibe n=10 Participants Ezetimibe added to max tolerated dose statin
Incidents of Rhabdomyolysis	0 participants 30.55	0 participants 12.97	0 participants 20.07

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Change in HDL

Outcome measures

Measure	Niacin n=9 Participants Niacin added to max tolerated dose of statin	Colestipol n=9 Participants Colestipol added to max dose statin	Ezetimibe n=10 Participants Ezetimibe added to max tolerated dose statin
Change in HDL From Baseline to 12 Weeks. baseline	42.33 mg/dl Standard Deviation 11.20	39.22 mg/dl Standard Deviation 14.22	32.90 mg/dl Standard Deviation 5.15
Change in HDL From Baseline to 12 Weeks. 12 weeks	43.00 mg/dl Standard Deviation 11.62	37.56 mg/dl Standard Deviation 7.83	34.70 mg/dl Standard Deviation 10.39

Adverse Events

Niacin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Colestipol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ezetimibe

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Niacin n=10 participants at risk Niacin added to max tolerated dose of statin	Colestipol n=10 participants at risk Colestipol added to max dose statin	Ezetimibe n=10 participants at risk Ezetimibe added to max tolerated dose statin
Hepatobiliary disorders Elevated LFTs	10.0% 1/10 • 12 weeks	10.0% 1/10 • 12 weeks	20.0% 2/10 • 12 weeks
Gastrointestinal disorders Indestion and belching	0.00% 0/10 • 12 weeks	0.00% 0/10 • 12 weeks	10.0% 1/10 • 12 weeks
Skin and subcutaneous tissue disorders Flushing	50.0% 5/10 • 12 weeks	0.00% 0/10 • 12 weeks	0.00% 0/10 • 12 weeks
Gastrointestinal disorders Loose Stools	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks	0.00% 0/10 • 12 weeks
Gastrointestinal disorders Flatulence	0.00% 0/10 • 12 weeks	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks
Gastrointestinal disorders Constipation	0.00% 0/10 • 12 weeks	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • 12 weeks	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks
Vascular disorders Edema	0.00% 0/10 • 12 weeks	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks

Additional Information

Raela Williford, PharmD

TuscaloosaREAC

Phone: (205) 554-2000

Email: Raela.Williford@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place