Trial Outcomes & Findings for The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study (NCT NCT00817843)

Results Overview

A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

After 6 weeks of treatment

Results posted on

2013-01-09

Participant Flow

Between and patients were screened of which subjects were randomized in the following centers UMC Utrecht, Utrecht, the Netherlands AMC, Amsterdam, the Netherlands Vascular Research Center, Hoorn, the Netherlands Tweesteden Ziekenhuis, Waalwijk, the Netherlands Hospital Arnau de Vilanova, Lleida, Spain

Prior to randomization subjects were given a 2 week placebo controled run-in phase to test for adequate compliance.

Participant milestones

Participant milestones
Measure	Simvastatin 80mg First, Then Simvastatin/Ezetimibe 10/10mg First 6 weeks of treatment with simvastatin 80 mg with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin/ezetimibe 10/10 mg combination and placebo	Simvastatin/Ezetimibe 10/10mg First, Then Simvastatin 80mg First 6 weeks of treatment with simvastatin/ezetimibe 10/10 mg combination with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin 80 mg and placebo
First Period (6 Weeks) STARTED	50	50
First Period (6 Weeks) COMPLETED	42	46
First Period (6 Weeks) NOT COMPLETED	8	4
Washout Period (6 Weeks) STARTED	42	46
Washout Period (6 Weeks) COMPLETED	41	45
Washout Period (6 Weeks) NOT COMPLETED	1	1
Second Period (6 Weeks) STARTED	41	45
Second Period (6 Weeks) COMPLETED	41	44
Second Period (6 Weeks) NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg n=100 Participants All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age Continuous	57 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Region of Enrollment Spain	16 participants n=5 Participants
Region of Enrollment Netherlands	84 participants n=5 Participants

PRIMARY outcome

Timeframe: After 6 weeks of treatment

Population: Analyses were performed in randomized patients who received ≥1 dose of study treatment and who had a post-randomization analysis measurement

A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg

Outcome measures

Outcome measures
Measure	Simvastatin 80 mg n=91 Participants 6 weeks of treatment with simvastatin 80 mg	Simvastatin 10 mg / Ezetimibe 10 mg n=90 Participants 6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg
Treatment Difference in (Postprandial-Fasting) FMD	-0.34 % (change FMD) Standard Error 0.210	-0.43 % (change FMD) Standard Error 0.202

SECONDARY outcome

Timeframe: after 6 weeks of treatment (crossover)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after 6 weeks of treatment (crossover)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after 6 weeks of treatment (crossover)

Outcome measures

Outcome data not reported

Adverse Events

Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg n=100 participants at risk All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
Vascular disorders Myocardial infarction	1.0% 1/100 • Number of events 1
Gastrointestinal disorders Appendicitis	1.0% 1/100 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Professor F.L.J. Visseren, MD PhD

UMC Utrecht

Phone: 0031-88-7555555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place