5. Limitation
heterogenous
REGRESSION, PAD, DILATION, DYSLIPIDEMIA
The present study has several limitations.First, the open-label pilot study design, small sample size, and short follow-up duration might have led to biased and heterogenous findings. For example, this study originally planned to include 60 patients as the calculated required sample size; however, only 38 patients were enrolled, as the number of patients was lower than expected. Therefore, a large-scale, double-blind, randomized controlled trial with a long follow-up duration is needed to validate our findings.Second, we only considered PAD improvement based on the ABI scores; however, it would be useful to confirm the results using other PAD screening methods, such as the 6-min walking test and pain-free walking distance, or other modalities for evaluating PAD, such as flow-mediated dilation, skin perfusion pressure, and brachial-ankle pulse wave velocity [Third, we did not maintain a record of the usage of the remaining medications in this study. However, since the patients were verbally asked if they consumed residual medications and no significant residual medication use was noted, we do not believe that medication compliance was affected significantly.Fourth, another limitation is that we are not able to rigorously assess the type of dyslipidemia.Finally, the multiple regression analysis results showed that the RLP-C-lowering effect was independent of statin use; however, the statin dose was not standardized. Therefore, a fixed statin dose should be used in future studies to further validate this finding.