Trial Outcomes & Findings for The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome (NCT NCT00664742)

Last Updated: 2011-05-17

Results Overview

Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

614 participants

Primary outcome timeframe

Baseline,6 weeks

Results posted on

2011-05-17

Participant Flow

614 participants enrolled. 607 participants treated.

Participant milestones

Participant milestones
Measure	Fluvastatin XL® Treatment 80 mg once daily, at bedtime.
Overall Study STARTED	607
Overall Study COMPLETED	481
Overall Study NOT COMPLETED	126

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluvastatin XL® Treatment 80 mg once daily, at bedtime.
Overall Study Withdrawn due to adverse events	3
Overall Study Withdrawal by Subject	31
Overall Study Lost to Follow-up	92

Baseline Characteristics

The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluvastatin XL® Treatment n=607 Participants 80 mg once daily, at bedtime.
Age Continuous	54 years STANDARD_DEVIATION 10 • n=5 Participants
Sex/Gender, Customized Female	421 participants n=5 Participants
Sex/Gender, Customized Male	183 participants n=5 Participants
Sex/Gender, Customized Gender not recorded	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline,6 weeks

Population: The analysis was done on the Per Protocol Population which consists of all participants who did not violate inclusion/ exclusion criteria, completed the treatment study phase or withdrew from the study due to progression, death, or toxicity (AE related to study drug) and had at least one key response evaluation.

Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.

Outcome measures

Outcome measures
Measure	Fluvastatin XL® Treatment n=481 Participants 80 mg once daily, at bedtime.
Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6 Change in TC	-50.4 mg/dL 95% Confidence Interval 28.99897 • Interval -53.4 to -47.5
Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6 Change in HDL-C	-0.6 mg/dL 95% Confidence Interval 12.30119 • Interval -1.4 to 0.2
Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6 Change in LDL-C	-45.2 mg/dL 95% Confidence Interval 62.92132 • Interval -47.7 to -42.8
Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6 Change in TG	-22.3 mg/dL 95% Confidence Interval 71.50801 • Interval -27.9 to -16.7

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: This analysis was done on the safety population which consists of all participants who received at least one dose of study medication.

The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC \<200 mg/dL, LDL-C \<100 mg/dL, HDL-C \>=60 mg/dL and TG \< 150 mg/dL.

Outcome measures

Outcome measures
Measure	Fluvastatin XL® Treatment n=607 Participants 80 mg once daily, at bedtime.
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels TC<200 mg/dL at Baseline	22.4 Percentage of Participants
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels TC<200 mg/dL at Week-6	64.9 Percentage of Participants
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels LDL-C < 100 mg/dL at Baseline	0.7 Percentage of Participants
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels LDL-C < 100 mg/dL at Week-6	51.2 Percentage of Participants
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels HDL-C >= 60 mg/dL at Baseline	13.7 Percentage of Participants
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels HDL-C >= 60 mg/dL at Week-6	10.0 Percentage of Participants
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels TG < 150 mg/dL at Baseline	33.6 Percentage of Participants
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels TG < 150 mg/dL at Week-6	39.5 Percentage of Participants

Adverse Events

Fluvastatin XL® Treatment

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluvastatin XL® Treatment n=607 participants at risk 80 mg once daily, at bedtime.
Musculoskeletal and connective tissue disorders Rhabdomyolysis and Myalgia	0.16% 1/607 • 6 Weeks
Cardiac disorders Coronary Artery Bypass Surgery	0.16% 1/607 • 6 Weeks

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER