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Open-label study to assess the efficacy, safety, and tolerability of fluvastatin versus bezafibrate for
G Fanghänel1, J Espinosa, D Olivares
1Endocrinology Service, Hospital General de México, SSA, México, D.F.
Insights
Fluvastatin significantly reduced total cholesterol and LDL-C in patients with high cholesterol, unlike bezafibrate. This study highlights fluvastatin
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Elevated total cholesterol and LDL-C are key risk factors for coronary artery disease (CAD).
- Effective lipid-lowering therapies are crucial for slowing atherosclerosis and reducing CAD risk.
- Dietary interventions alone are insufficient for many patients with hypercholesterolemia.
Purpose of the Study:
- To compare the efficacy, safety, and tolerability of fluvastatin versus slow-release bezafibrate.
- To evaluate lipid-lowering effects in patients with hypercholesterolemia unresponsive to diet.
- To assess changes in total cholesterol and LDL-C levels after 12 weeks of treatment.
Main Methods:
- A randomized study comparing fluvastatin (40 mg daily) and bezafibrate (400 mg daily) in patients with cholesterol > 241 mg/dL.
- Participants had failed to respond to 8 weeks of a low-cholesterol diet (< 300 mg/day).
- Lipid profiles were assessed after a 12-week treatment period.
Main Results:
- Fluvastatin group showed a 27% mean decrease in total cholesterol (p < 0.001) versus 8% for bezafibrate (p < 0.005).
- LDL-C significantly decreased by 46% in the fluvastatin group (p < 0.001), but showed no significant change in the bezafibrate group.
- Mean cholesterol levels decreased from 271 to 197.4 mg/dL with fluvastatin, and from 278.6 to 255.8 mg/dL with bezafibrate.
Conclusions:
- Fluvastatin demonstrated superior efficacy in reducing total cholesterol and LDL-C compared to bezafibrate in this patient cohort.
- Fluvastatin is an effective treatment option for hypercholesterolemia unresponsive to dietary management.
- Further studies are warranted to assess long-term safety and tolerability profiles.
Abstract:
Increased levels of total cholesterol and low density lipoprotein cholesterol (LDL-C) are associated with the development of coronary artery disease, which has become a worldwide public health problem. Clinical trials show that, in the long term, effective lowering of total cholesterol and raising of high density lipoprotein cholesterol (HDL-C) can slow atherosclerosis progression and reduce coronary artery disease risk. This study evaluated the efficacy, safety, and tolerability of fluvastatin versus bezafibrate (slow release) in patients with cholesterol > 241 mg/dL (6.2 mmol/liter) not responding to dietary treatment alone (cholesterol < 300 mg/day for 8 weeks). Patients were divided into 2 groups: group A (13 women, 7 men; mean age, 47.8 +/- 9.7 years; range, 30-70) received 40 mg fluvastatin once daily with their evening meal; group B (14 women, 6 men; mean age, 45 +/- 11 years, range, 25-68) received 400 mg bezafibrate once daily with either breakfast or their evening meal. After 12 weeks of treatment, the mean cholesterol decrease in group A was 27% (from 271 +/- 51.4 to 197.4 +/- 24.3 mg/dL; p < 0.001) versus 8% (from 278.6 +/- 33.2 to 255.8 +/- 20.3 mg/dL; p < 0.005) in group B. At the same time point, LDL-C was significantly decreased in group A (from 197.9 +/- 49 to 107.5 +/- 27.6 mg/dL; p < 0.001) but not in group B (from 181.6 +/- 39.6 to 173.3 +/- 24.3 mg/dL).(ABSTRACT TRUNCATED AT 250 WORDS)