The effects of pemafibrate and omega-3 fatty acid ethyl on apoB-48 in dyslipidemic patients treated with statin: A prospective, multicenter, open-label, randomized, parallel group trial in Japan (PROUD48 study)
Source : https://www.frontiersin.org/articles/10.3389/fcvm.2023.1094100/full
BackgroundWe compared the lowering effects of pemafibrate and omega-3 fatty acid ethyl on fasting apolipoprotein (apo) B-48 (apoB-48), a marker that reflects postprandial hypertriglyceridemia, which is one of the residual risks for atherosclerotic cardiovascular disease (ASCVD) with statin treatment.MethodsThis prospective, multicenter, open-label, randomized, parallel group trial was conducted at 4 medical institutions between April 2020 and May 2022.
Conclusions: This is the first randomized trial to compare the lowering effects of pemafibrate and omega-3 fatty acid ethyl on fasting apoB-48. We concluded that pemafibrate was superior to omega-3 fatty acid ethyl in lowering effect of fasting apoB-48. Pemafibrate is expected to reduce the residual risk for ASCVD with statin treatment.
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• Source: Frontiers in Cardiovascular Medicine
• Conclusions: “This is the first randomized trial to compare the lowering effects of pemafibrate and omega-3 fatty acid ethyl on fasting apoB-48. We concluded that pemafibrate was superior to omega-3 fatty acid ethyl in lowering effect of fasting apoB-48. Pemafibrate is expected to reduce the residual risk for ASCVD with statin treatment.”
• In the current prospective, multicenter trial, Japanese researchers compared the lipid-lowering impact of pemafibrate and omega-3 fatty acid ethyl on fasting apolipoprotein (apo) B-48 (apoB-48) in a total of 126 patients. The participants with dyslipidemia received statin treatment for more than 4 weeks and exhibited fasting triglyceride (TG) levels of ≥177 mg/dl. They were randomly assigned to either a 16-week regimen of pemafibrate 0.4 mg per day as the treatment group (PEMA; n = 63) or omega-3 fatty acid ethyl 4 g per day (OMEGA-3; n = 63).
• Fasting apoB-48 is a marker of postprandial hypertriglyceridemia. It is a residual risk factor of ASCVD with statin treatment. In the current study, the percentage drop in fasting apoB-48 level from baseline to week 16 was −50.8% with pemafibrate and −17.5% with omega-3 fatty acid.
• “These findings demonstrated that pemafibrate is superior to omega-3 fatty acid ethyl in lowering effect of fasting apoB-48, and also provide the important insights regarding which drug, pemafibrate or omega-3 fatty acid ethyl, is the better option for the treatment of hypertriglyceridemia to reduce the residual ASCVD risk associated with TRLs in patients with dyslipidemia receiving statin treatment,” the authors wrote.
• These findings reproduced those of other trials, which were done with different durations.
• One limitation of this study is that there is no control group taking placebo, as well as no groups taking combination treatment. Another limitation is that the primary endpoint, apoB-48, is a marker of postprandial hypertriglyceridemia, and the researchers were unable to evaluate the effects on major adverse cardiovascular events.