Phase 3 N=36 Randomized Double-blind Treatment

Bezafibrate Plus Berberine in Mixed Dyslipidemia

Mixed Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT02548832 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Triglycerides After 90 Days — 2.3; 1.1; 1.3 mmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Berberine (Drug); Bezafibrate (Drug); Berberine plus Bezafibrate (Drug)
Age: Adult · 30+ yrs
Sex: All
Sponsor: University of Guadalajara
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Triglycerides After 90 Days	2.3; 1.1; 1.3	—
PRIMARY Total Cholesterol After 90 Days.	5.3; 5.8; 4.6	—
PRIMARY Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days	2.8; 2.4; 2.2	—
PRIMARY High Density Lipoprotein Cholesterol (HDL-c) After 90 Days	1.5; 2.0; 1.8	—
PRIMARY Very Low Density Lipoprotein After 90 Days	0.4; 0.2; 0.2	—
SECONDARY Body Weight (BW) After 90 Days	75.4; 83.6; 73.0	—
SECONDARY Body Mass Index (BMI) After 90 Days	29.6; 31.8; 28.4	—
SECONDARY Waist Circumference (WC) After 90 Days	94.0; 98.0; 88.7	—
SECONDARY Systolic Blood Pressure After 90 Days	122; 122; 114	—
SECONDARY Diastolic Blood Pressure After 90 Days	73; 74; 72	—
SECONDARY Fasting Serum Glucose (FSG) After 90 Days	5.6; 5.5; 5.3	—
SECONDARY Uric Acid After 90 Days	285.5; 350.9; 279.5	—
SECONDARY Creatinine After 90 Days	53.0; 44.2; 61.9	—

Summary

Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to increased triglycerides (TG) and reduced high-density lipoprotein cholesterol (HDL-C) as part of the elements for classification, which includes mixed dyslipidemia. Currently, fibrates, such as bezafibrate, are drugs used in treating hypertriglyceridemia, besides reducing the risk of coronary disease. However, although this treatment is safe, it is not without risks; with increased prevalence of adverse effects as the dose thereof is increased or joins combination with a statin drug for the treatment of mixed dyslipidemia long term. Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides may be useful in combination with bezafibrate in the treatment of mixed dyslipidemia and as an option with lower cost and lower frequency of adverse events.

Eligibility Criteria

Inclusion Criteria

A. Men and women

B. Accomplished age 30 to 60 years

C. Diagnosis of mixed dyslipidemia established to meet the following criteria:

Total cholesterol > 5,17 mmol/l.
Triglycerides > 1,7 mmol/l.

D. BMI of 25 kg / m^2 to 39.9 kg / m^2, weight stable over the past three months, defined as a variability in the lower body weight of 5%.

E. No drug treatment for lipid profile 3 months prior to baseline.

F. Women must ensure a non-hormonal method to avoid pregnancy during the study period.

G. Written information consent

Exclusion Criteria

A. Removal for informed consent letter

B. Loss of monitoring

C. Presence of serious adverse event

D. Adherence to treatment <80%

E. Consumption of drugs known about lipid profile, glucose metabolism, blood pressure and body weight during the intervention period influence

F. Intolerance or not tolerability or hypersensitivity to the compounds used in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02548832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.