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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 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2012-12-21

No results posted yet for this study

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

Interventions

DRUG

Rosuvastatin,SFC fenofibrate

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00965315 on ClinicalTrials.gov