K-877 (pemafibrate) add-on therapy to statin treatment reduced fasting triglyceride levels by approximately 50% compared to statin monotherapy (p < 0.001).
RCT (n=611)
Double-blind
parallel group
Yes
Does pemafibrate added to statin therapy reduce fasting triglyceride levels in patients with residual hypertriglyceridaemia?
Pemafibrate added to statin therapy safely and significantly reduces fasting triglycerides and improves atherogenic lipoprotein profiles in patients with residual hypertriglyceridaemia.
p-value: p=<0.001
BACKGROUND AND AIMS: Substantial residual cardiovascular risks remain despite intensive statin treatment. Residual risks with high triglyceride and low high-density lipoprotein cholesterol are not the primary targets of statins. K-877 (pemafibrate) demonstrated robust efficacy on triglycerides and high-density lipoprotein cholesterol and a good safety profile as a monotherapy. The aim of these studies was to evaluate the efficacy and safety of K-877 add-on therapy to treat residual hypertriglyceridaemia during statin treatment. METHODS: The objectives were investigated in two, multicentre, randomised, double-blind, placebo-controlled, parallel group comparison clinical trials: (A) K-877 0.1, 0.2, and 0.4 mg/day in combination with pitavastatin for 12 weeks in 188 patients, (B) K-877 0.2 (fixed dose) and 0.2 (0.4) (conditional up-titration) mg/day in combination with any statin for 24 weeks in 423 patients. RESULTS: In both studies, we found a robust reduction in fasting triglyceride levels by approximately 50% in all combination therapy groups, which was significant compared to the statin-monotherapy (placebo) groups (p < 0.001). High-performance liquid chromatography analysis for lipoprotein subfractions revealed that atherogenic lipoprotein profiles were ameliorated by K-877 add-on therapy, i.e. small low-density lipoproteins decreased whereas larger ones increased, and larger high-density lipoproteins decreased whereas smaller ones increased. The incidence rates of adverse events and adverse drug reactions in K-877 combination therapy groups were comparable to those in statin-monotherapy groups without any noteworthy event in both studies. CONCLUSIONS: These results strongly support the favourable benefit-to-risk ratio of K-877 add-on therapy in combination with statin treatment.
Arai et al. (2017) conducted an RCT in dyslipidaemia (n=611). K-877 (pemafibrate) vs. Placebo (statin monotherapy) was evaluated on fasting triglyceride levels (p=<0.001). K-877 (pemafibrate) add-on therapy to statin treatment reduced fasting triglyceride levels by approximately 50% compared to statin monotherapy (p < 0.001).