Abstract
PurposeResidual cardiovascular risk reduction by fenofibrate in patients with high serum triglyceride (TG) levels despite previous statin monotherapy is not well characterized. The purpose of this study was to evaluate the efficacy and safety of a combination of choline fenofibrate and statin in patients with inadequately controlled TG levels despite previous statin monotherapy. MethodsThis prospective, multicenter, randomized, double-blind study was conducted in Korea. A total of 133 patients with controlled LDL-C but elevated TG levels, already receiving statin monotherapy, were enrolled in the study, which was conducted from July 2018 to December 2019. Patients were randomly assigned to receive combination therapy with choline fenofibrate and statin or statin monotherapy in a 1:1 ratio. After 8 weeks of treatment, the lipid profiles and safety parameters of the patients in the 2 groups were compared. FindingsThe study included 127 patients (64 in the combination group and 63 in the control group) older than 19 years. After 8 weeks of therapy, mean serum TG levels significantly decreased from 269.8 to 145.5 mg/dL (P < 0.0001) in the combination therapy group, whereas no significant changes occurred in the statin monotherapy group (from 271.1 to 280.5 mg/dL). Contrarily, the mean serum HDLC levels significantly increased from 45.0 to 50.4 mg/dL (P = 0.0004) in the combination therapy group, whereas there were no significant changes in the monotherapy group (from 44.3 to 44.7 mg/dL). There were no additional serious adverse events in the combination therapy group compared with the statin monotherapy group. ImplicationsThe combination therapy using choline fenofibrate and statin was found to be effective in serum TG control and likely tolerable in patients with high TG levels despite statin monotherapy. A larger study, conducted for a longer duration, is needed to evaluate the effectiveness of this combination in reducing cardiovascular risk. ClinicalTrials.gov identifier: NCT03874260.
Highlights
Fenofibrate is a peroxisome proliferator activated receptor α agonist that is thought to help control triglyceride (TG) levels and reduce residual cardiovascular risk, which cannot be achieved with statin therapy alone.[1]
In the Fenofibrate Intervention and Event Lowering of Diabetes (FIELD) study, a major, large-scale randomized controlled trial that evaluated the effects of fenofibrate on cardiovascular risk reduction, cardiovascular death, and nonfatal myocardial infarction, the incidence of coronary events was 11% lower in patients treated with fenofibrate than in the control group
Four patients who did not take the investigational product were excluded from the study, and 129 patients were included in the safety set (65 from the combination group and 64 from the control group)
Summary
Fenofibrate is a peroxisome proliferator activated receptor α agonist that is thought to help control triglyceride (TG) levels and reduce residual cardiovascular risk, which cannot be achieved with statin therapy alone.[1] In the Fenofibrate Intervention and Event Lowering of Diabetes (FIELD) study, a major, large-scale randomized controlled trial that evaluated the effects of fenofibrate on cardiovascular risk reduction, cardiovascular death, and nonfatal myocardial infarction, the incidence of coronary events was 11% lower in patients treated with fenofibrate than in the control group. The potential clinical implications of fenofibrate continue to be studied.[4]
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