Lipid Metabolism Disorders
Conditions
Keywords
Dyslipidemias, Fluvastatin sodium, Chinese
Brief summary
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.
Interventions
Fluvastatin sodium Extended Release Tablets 80mg
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007). * Not having achieved lipid treatment goals despite following a cholesterol restrictive diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the 6-week open-label study phase). * Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion in the 12-week double-blind study phase).
Exclusion criteria
* Patients with known hypersensitivity to fluvastatin or any of the excipients. * Dyslipidemia secondary to other causes. * Known muscle disease or history of muscle disease and/or serum CPK levels greater than 2 x upper limit of normal (ULN). * A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the previous 8 weeks. * Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x ULN. * Patients on a proper lipid lowering monotherapy (defined as at least 12 weeks continuous monotherapy with a recommended dose and administration in the label) within the previous 3 months prior to visit 1. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF) | Baseline, week 12 | After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | Baseline, week 4, week 8, week 12, Endpoint | After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12 |
| Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Baseline, week 4, week 8, week 12, Endpoint | LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels \< 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels \< 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluvastatin Sodium Extended Release Tablet Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks | 218 |
| Fluvastatin Sodium Immediate Release Capsule Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks | 218 |
| Total | 436 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 6 |
| Overall Study | Lost to Follow-up | 5 | 7 |
| Overall Study | Other | 5 | 3 |
| Overall Study | Withdrawal by Subject | 11 | 16 |
Baseline characteristics
| Characteristic | Fluvastatin Sodium Extended Release Tablet | Fluvastatin Sodium Immediate Release Capsule | Total |
|---|---|---|---|
| Age, Continuous | 58.8 Years STANDARD_DEVIATION 8.39 | 60.4 Years STANDARD_DEVIATION 9.3 | 59.6 Years STANDARD_DEVIATION 8.88 |
| Sex: Female, Male Female | 142 Participants | 154 Participants | 296 Participants |
| Sex: Female, Male Male | 76 Participants | 64 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 218 | 14 / 218 | 32 / 436 |
| serious Total, serious adverse events | 4 / 218 | 2 / 218 | 6 / 436 |
Outcome results
Primary
Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.
Time frame: Baseline, week 12
Population: FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluvastatin Sodium Extended Release Tablet | Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF) | -8.692 Percent change | Standard Error 1.4229 |
| Fluvastatin Sodium Immediate Release Capsule | Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF) | -7.887 Percent change | Standard Error 1.4258 |
Secondary
Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12
Time frame: Baseline, week 4, week 8, week 12, Endpoint
Population: FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG week 12 (n=192,189) | -0.056 mmol/L | Standard Error 0.0498 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C week 8 (n=193,194) | -0.418 mmol/L | Standard Error 0.046 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC Endpoint (n=210,214) | -0.294 mmol/L | Standard Error 0.0548 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C week 4 (n=205,211) | -0.004 mmol/L | Standard Error 0.0118 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C week 8 (n=193,194) | 0.012 mmol/L | Standard Error 0.0128 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C week 12 (n=192,189) | 0.034 mmol/L | Standard Error 0.0129 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG week 8 (n=193,194) | -0.065 mmol/L | Standard Error 0.0373 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG Endpoint (n=210,214) | -0.031 mmol/L | Standard Error 0.0559 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C week 12 (n=192,189) | -0.353 mmol/L | Standard Error 0.0475 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C Endpoint (n=210,214) | -0.339 mmol/L | Standard Error 0.0483 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC week 4 (n=205,211) | -0.450 mmol/L | Standard Error 0.0497 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC week week 8 (n=193,194) | -0.409 mmol/L | Standard Error 0.0497 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC week 12 (n=192,189) | -0.314 mmol/L | Standard Error 0.0531 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C Endpoint (n=210,214) | 0.030 mmol/L | Standard Error 0.0123 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non HDL-C week 4 (n=205,211) | -0.447 mmol/L | Standard Error 0.0488 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non HDL-C week 8 (n=193,194) | -0.422 mmol/L | Standard Error 0.0484 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non HDL-C week 12 (192,189) | -0.350 mmol/L | Standard Error 0.0528 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non-HDL Endpoint (n=210,214) | -0.325 mmol/L | Standard Error 0.055 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG week 4(n=205,211) | -0.055 mmol/L | Standard Error 0.055 |
| Fluvastatin Sodium Extended Release Tablet | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C week 4 (n=210,214) | -0.447 mmol/L | Standard Error 0.0427 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non-HDL Endpoint (n=210,214) | -0.305 mmol/L | Standard Error 0.0551 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C week 4 (n=210,214) | -0.438 mmol/L | Standard Error 0.0426 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC week 4 (n=205,211) | -0.457 mmol/L | Standard Error 0.0495 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non HDL-C week 8 (n=193,194) | -0.438 mmol/L | Standard Error 0.049 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC Endpoint (n=210,214) | -0.290 mmol/L | Standard Error 0.0549 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC week week 8 (n=193,194) | -0.419 mmol/L | Standard Error 0.0503 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C week 4 (n=205,211) | 0.002 mmol/L | Standard Error 0.0118 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG week 8 (n=193,194) | -0.134 mmol/L | Standard Error 0.0381 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C week 8 (n=193,194) | 0.016 mmol/L | Standard Error 0.013 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TC week 12 (n=192,189) | -0.376 mmol/L | Standard Error 0.0542 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C week 12 (n=192,189) | 0.010 mmol/L | Standard Error 0.0132 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non HDL-C week 12 (192,189) | -0.388 mmol/L | Standard Error 0.054 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG week 12 (n=192,189) | -0.124 mmol/L | Standard Error 0.0514 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | HDL-C Endpoint (n=210,214) | 0.012 mmol/L | Standard Error 0.0124 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG Endpoint (n=210,214) | -0.088 mmol/L | Standard Error 0.0566 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C week 8 (n=193,194) | -0.408 mmol/L | Standard Error 0.0465 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | TG week 4(n=205,211) | -0.096 mmol/L | Standard Error 0.0554 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C week 12 (n=192,189) | -0.377 mmol/L | Standard Error 0.0485 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | non HDL-C week 4 (n=205,211) | -0.461 mmol/L | Standard Error 0.0487 |
| Fluvastatin Sodium Immediate Release Capsule | Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG) | LDL-C Endpoint (n=210,214) | -0.298 mmol/L | Standard Error 0.0484 |
Secondary
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels \< 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels \< 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect.
Time frame: Baseline, week 4, week 8, week 12, Endpoint
Population: FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk at week 4 | 50 Percent of participants |
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk at week 8 | 70 Percent of participants |
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk at week 12 | 50 Percent of participants |
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at week 4 | 27.2 Percent of participants |
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at week 8 | 27.9 Percent of participants |
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk Endpoint | 50 Percent of participants |
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at week 12 | 33 Percent of participants |
| Fluvastatin Sodium Extended Release Tablet | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at Endpoint | 31.5 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at Endpoint | 24.5 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk at week 4 | 57.1 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk at week 12 | 54.5 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk at week 8 | 58.3 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at week 12 | 26.4 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | Moderate cardiovascular risk Endpoint | 42.9 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at week 8 | 29.1 Percent of participants |
| Fluvastatin Sodium Immediate Release Capsule | Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint | high cardiovascular risk at week 4 | 25.9 Percent of participants |