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There are conflicting data on the lipid-lowering effect of policosanol (used alone or in combination with statins).
In some high-quality studies, whether it has any beneficial effects on serum low-density lipoprotein cholesterol (LDL-C) levels is still unclear.
Doubts
.
It is still unclear whether this diversity of results is due to genetic differences, but in the current European guidelines for the management of dyslipidemia, the use of policosanol has been discouraged
PCSK9 inhibitors have received widespread attention in the past ten years
.
PCSK9 is a protease that promotes the lysosomal degradation of LDL receptor (LDLr), thereby regulating the amount of LDL-C in the circulation
Therefore, the researchers conducted a prospective, single-center, randomized, double-blind, placebo-controlled trial of dietary supplements (containing octacosanol [20 mg] and vitamin K2-MK7 [45 μg]) Is it possible to affect the level of PCSK9 and its relationship with LDL-C in patients treated with chronic statins
?
method
methodFrom November 2015 to June 2016, in a randomized, double-blind, placebo-controlled trial, subjects were assigned to take a dietary supplement or placebo a day
.
Dietary supplements and placebos are produced and provided by AbelaPharm (Belgrade, Serbia)
The subjects were asked to avoid vitamin K and dietary supplements that interfere with LDL-C and triglyceride levels
.
The recommended low-fat diet and other medications are monitored through 3-day food/drug records at baseline and at the end of the study
result
resultAccording to the inclusion/exclusion criteria, a total of 177 patients were screened, and 87 patients were finally included
.
Among the 87 patients, 45 (51.
7%) and 42 (48.
Figure 1.
Research flow chart
Research flow chart Figure 1.
Research flow chart
The average age of the patients was 62.
6±0.
8 years, and males accounted for 63.
2%
.
The average BMI is 27.
Table 1.
Baseline characteristics
Baseline characteristics Table 1.
Baseline characteristics
Table 2 shows the serum PSCK9 levels and blood lipid parameters at baseline, 8 weeks and 13 weeks later
.
The PCSK9 levels of the two groups remained unchanged during the study period
Table 2.
Serum PSCK9 and blood lipid parameters after baseline, 8 weeks and 13 weeks
Serum PSCK9 and blood lipid parameters after baseline, 8 weeks and 13 weeks Table 2.
Serum PSCK9 and blood lipid parameters after baseline, 8 weeks and 13 weeks
In the dietary supplement group, a significant positive correlation (R=0.
383, P=0.
019) between the percentage change in PCSK9 levels and the percentage change in LDL-C levels was observed immediately after 8 weeks, and this change continued until the 13th Week, that is, from baseline to end point (R=0.
409, P=0.
012)
.
(Figure 2A, C)
No such correlation was observed in the placebo group (R = 0.
078, P = 0.
615 at week 8; R = -0.
103, P = 0.
508 at week 13)
.
(Figure 2B, D)
.
Therefore, in the dietary supplement group, the decrease in PCSK9 level was the largest, and the decrease in serum LDL-C level was also the largest
.
Figure 2.
Comparison of the percentage changes in serum PCSK9 and LDL-C levels induced by atorvastatin at 8 weeks and 13 weeks
Comparison of the percentage changes in serum PCSK9 and LDL-C levels induced by atorvastatin at 8 and 13 weeks Figure 2.
Comparison of the percentage changes in serum PCSK9 and LDL-C levels induced by atorvastatin at 8 and 13 weeks
Figure 3A shows the changes in serum PCSK9 levels of these participants from baseline to endpoint
.
By the end of the treatment period, there was no significant change in the PCSK9 levels of the two groups of patients
.
However, the effects of these two treatments are different
.
In these two subgroups, the baseline level of PCSK9 was comparable: 236.
26±31.
48 ng/mL in the dietary supplement group and 241.
11±25.
34 ng/mL in the placebo group (P>0.
05)
.
However, at the end of week 13, PCSK9 levels in the dietary supplement group were significantly reduced (280.
33±33.
96 in the placebo group and 191.
47±25.
85 in the supplement group; P = 0.
077)
.
Figure 3B shows the PCSK9 levels of subjects who experienced adverse lipid changes during the study
.
No significant changes in PCSK9 levels were observed in the dietary supplement group and the placebo group
.
Figure 3.
Serum PCSK9 levels of patients with favorable changes in LDL-C and HDL-C and adverse changes in LDL-C and HDL-C at baseline and 13 weeks after supplementation
Favorable changes in LDL-C and HDL-C, baseline and serum PCSK9 levels of patients with adverse changes in LDL-C and HDL-C and 13 weeks after supplementation Figure 3.
Favorable changes in LDL-C and HDL-C, Serum PCSK9 levels in patients with adverse changes in LDL-C and HDL-C at baseline and 13 weeks after supplementation
in conclusion
in conclusionThe study showed that dietary supplements can restore the positive physiological relationship between PCSK9 and LDL-C levels that were interrupted by statin treatment
.
Treatment with statins may lead to an increase in PCSK9, which is negatively correlated with LDL-C levels
.
Considering that spontaneous and/or drug-induced elevated PCSK9 levels may be an independent health risk factor, the findings of this study may have clinical relevance
.
Original source:
Original source:Ciric Milica Zrnic et al.
Supplementation with Octacosanol Affects the Level of PCSK9 and Restore Its Physiologic Relation with LDL-C in Patients on Chronic Statin Therapy .
[J].
Nutrients, 2021, 13(3).