A Multicenter Randomized Parallel-group Study to Investigate the Efficacy of a Combination of Rosuvastatin and Fenofibrate in the Patients With Diabetes or Atherosclerotic Vascular Diseases With Metabolic Syndrome

NCT00965315 | Unknown

• 1 other identifier: 200711014M
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetic patients have an excess risk of mortality due to cardiovascular diseases (CVD) compared to non-diabetics. Cardiovascular disease mortality rate is reportedly on the rise in several countries in the region, including urban China, Malaysia, Korea and Taiwan. Cardiovascular diseases and stroke are always the number 2 and 3 killers for Taiwanese population in recent years, and they really cost much from our medical resource. For treating dyslipidemia, one of the major risk factor for CVD, statins have been well documented to reduce CV deaths both for primary and secondary prevention in several large-scale trials. It has been reported that the clinical benefits of treating dyslipidemia in patients with diabetes mellitus should be at least equivalent to the benefits observed among those with cardiovascular disease. A meta-analysis of seven trials of statins found that treatment for about 5 years resulted in a 25% reduction in the combined outcome of coronary heart disease death and non-fatal myocardial infarction. Fibrates are another group of hypolipidemic drugs that regulate lipid metabolism and are used quite often in daily practice for diabetic dyslipidemia, because of its beneficial effect to reduce high TG and increase low HDL-C, which are the characteristic lipid abnormalities commonly seen in the patients with diabetes or metabolic syndrome. However, in recently published FIELD study, fenofibrate did not significantly reduce the risk of the primary outcome of coronary events in 9,795 participants with type 2 diabetes mellitus. The higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit. Furthermore, all the treatment trials to back up the lipid treatment guideline were conducted in Caucasians and no data about the combination therapy with fibrate and statin was published before.

Conditions

Diabetes; CVD

Keywords

CV (cardiovascular); MI (myocardial infarction); fenofibrate; rosuvastatin; this trial is to test the hypothesis that the addition of fenofibrate on rosuvastatin would provide a further reduction in the time

Interventions

Rosuvastatin,SFC fenofibrate DRUG

1. Rosuvastatin 10 mg once daily 2. Rosuvastatin 5 mg + SFC fenofibrate 160 mg

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• previous intolerance to statin or fibrate in low or high doses,
• liver enzyme levels more than 3 times the upper limit of normal,
• pregnancy or breastfeeding,
• nephrotic syndrome,
• uncontrolled diabetes mellitus (HbA1c \> 9),
• uncontrolled hypothyroidism,
• plasma LDL-C level higher than 190 mg/dL or triglyceride level higher than 500 mg/dL,
• coronary heart disease event or revascularisation within a month, congestive heart failure (New York Heart Association classification IIIb or IV),
• hemodynamically important valvular heart disease, gastrointestinal conditions affecting absorption of drugs,
• treatment with other drugs that seriously affect the pharmacokinetics of statins or fibrate,
• unexplained creatine phosphokinase concentrations six or more times the upper limit of normal,
• life-threatening malignancy,
• treatment with immuno suppressive or other lipid lowering drugs.
• Patients previously treated with monotherapy with statins or fibrates will be qualified if they have not already had titration to a dose higher than the equivalent of 5 mg/d of rosuvastatin or 80 mg/d of SFC fenofibrate.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus; Myocardial Infarction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

chau chung wu, Phd

CONTACT

+886-2-23123456; chauchungwu@ntu.edu.tw

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Last Updated: December 21, 2012

Record last verified: 2012-11