Trial Outcomes & Findings for Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. (NCT NCT00186537)

NCT ID: NCT00186537

Last Updated: 2017-01-12

Results Overview

Compare the change in mean triglyceride levels between groups after the interventions

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: Baseline, 12 weeks
• Results posted on: 2017-01-12

Participant Flow

Participant milestones

Measure	Fenofibrate 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Overall Study STARTED	19	12	16
Overall Study COMPLETED	12	12	13
Overall Study NOT COMPLETED	7	0	3

Reasons for withdrawal

Measure	Fenofibrate 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Overall Study Withdrawal by Subject	4	0	3
Overall Study ALT > 1.5 x ULN	3	0	0

Baseline Characteristics

Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.

Baseline characteristics by cohort

Measure	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss	Total n=37 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 7 • n=5 Participants	52 years STANDARD_DEVIATION 6 • n=7 Participants	53 years STANDARD_DEVIATION 7 • n=5 Participants	53 years STANDARD_DEVIATION 7 • n=4 Participants
Gender Female	3 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Gender Male	9 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: Triglycerides

Compare the change in mean triglyceride levels between groups after the interventions

Outcome measures

Measure	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate
Pre- and Post-Intervention Triglyceride Levels pre treatment	209 mg/dL Standard Deviation 67	201 mg/dL Standard Deviation 121	231 mg/dL Standard Deviation 117
Pre- and Post-Intervention Triglyceride Levels post treatment	232 mg/dL Standard Deviation 72	143 mg/dL Standard Deviation 49	140 mg/dL Standard Deviation 47

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: LDL cholesterol

Compare the change in mean LDL Cholesterol levels between groups after the interventions

Outcome measures

Measure	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate
Pre- and Post-Intervention LDL Cholesterol Levels pre treatment	119 mg/dL Standard Deviation 41	144 mg/dL Standard Deviation 34	114 mg/dL Standard Deviation 34
Pre- and Post-Intervention LDL Cholesterol Levels post treatment	129 mg/dL Standard Deviation 37	128 mg/dL Standard Deviation 34	111 mg/dL Standard Deviation 22

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: HDL Cholesterol

Compare the change in mean HDL Cholesterol levels between groups after the interventions

Outcome measures

Measure	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate
Pre- and Post-Intervention HDL Cholesterol Levels pre treatment	40 mg/dL Standard Deviation 11	38 mg/dL Standard Deviation 9	35 mg/dL Standard Deviation 7
Pre- and Post-Intervention HDL Cholesterol Levels Post treatment	42 mg/dL Standard Deviation 13	38 mg/dL Standard Deviation 7	36 mg/dL Standard Deviation 8

Adverse Events

Fenofibrate

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Rosiglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calorie Restricted Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fenofibrate n=19 participants at risk 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone n=12 participants at risk 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=16 participants at risk calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Hepatobiliary disorders alanine aminotramsferase ( ALT) elevation greater than 1.5 times normal of upper limit	15.8% 3/19 • Number of events 3	0.00% 0/12	0.00% 0/16

Additional Information

Dr. Gerald Reaven

Stanford University

Phone: 650-724-3416

Email: greaven@stanford.edu

Results disclosure agreements

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