Choline Fenofibrate Delayed Release Capsules Versus Conventional Fenofibrate Tablets for Dyslipidemia: A Randomized, Non-Inferiority Trial
Fibrates are the most potent drugs to lower serum triglycerides (TG). Many formulations of fenofibrate have been developed to enhance its pharmacologic properties. Even though choline fenofibrate is approved in 2008 by Food and Drug Administration in the United States and has been used in clinical practice for more than 5 years, there is no clinical evidence available to compare the choline fenofibrate formulation versus the conventional fenofibrate formulation for the treatment of dyslipidemia. The author Agarwal and colleagues (2020) conducted a study titled “Choline Fenofibrate Delayed-Release Capsules Versus Conventional Fenofibrate Tablets for Dyslipidemia: A Randomized, Non-Inferiority Trial” in the Journal of The Association of Physicians of India. Summary of the findings can be studied below:
Objectives:
To investigate the safety and potency of choline fenofibrate 135 mg delayed-release capsules versus conventional fenofibrate 160 mg tablets in patients with dyslipidemia.
Method:
A total of 200 participants comprising adult men and women with TG ≥150 mg/dl have completed the study as per protocol. Patients were randomly divided into two groups to obtain either conventional fenofibrate 160 mg tablets (control group) or choline fenofibrate 135 mg delayed-release capsules (test group) for every day till 12 weeks.
The primary outcome was the mean percentage change from baseline in TG at week 12. Secondary outcomes included the mean percentage change from baseline in LDL cholesterol, VLDL cholesterol, HDL cholesterol, and total cholesterol at week 12; and assessment of global efficacy.
Findings:
Investigators found that choline fenofibrate 135 mg delayed-release capsules are not lower than conventional fenofibrate 160 mg tablets for treating serum TG levels. Due to the addition of statin and fenofibrate for the reduction of TG levels, a large number of participants are found to achieve normal TG levels. The study found comparable evidence with a higher percentage of targeted outcomes found in a test group for a reduction in VLDL-C, TC, LDL-C, and an increase in HDL-C.
Patients didn’t report any adverse events and both formulations were well tolerated; further suggesting that choline fenofibrate 135 mg delayed-release capsules and conventional fenofibrate 160 mg tablets could have comparable safety and efficacy in clinical practice.
Limitations:
Patients with hypertriglyceridemia or mixed dyslipidemia were enrolled in the study. Hence, investigators suggest to not generalize these findings to other populations. Authors acknowledge future studies of longer duration to further evaluate these results. Due to the inability to perform creatine phosphokinase (CPK) measurement, the study might have missed asymptomatic patients with increase CPK levels which are common in some patients receiving fibrate and statin therapy.
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