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Supplementation with Octacosanol Affects the Level of PCSK9 and Restore Its Physiologic Relation with LDL-C in Patients on Chronic Statin Therapy.

ABSTRACT: Dietary supplementation with sugar cane derivates may modulate low-density lipoprotein cholesterol (LDL-C) and proprotein convertase subtilisin/kexin type 9 (PCSK9) levels. The purpose of this study was to determine if dietary supplement (DS), containing Octacosanol (20 mg) and vitamin K2 (45 µg), could restore the disrupted physiologic relation between LDL-C and serum PCSK9. Double-blind, randomized, placebo-controlled, single-center study including 87 patients on chronic atorvastatin therapy was conducted. Eighty-seven patients were randomized to receive DS (n = 42) or placebo (n = 45), and followed for 13 weeks. Serum PCSK9 levels, lipid parameters and their relationship were the main efficacy endpoints. The absolute levels of PCSK9 and LDL-C were not significantly different from baseline to 13 weeks. However, physiologic correlation between % change of PCSK9 and % change of LDL-C levels was normalized only in the group of patients treated with DS (r = 0.409, p = 0.012). This study shows that DS can restore statin disrupted physiologic positive correlation between PCSK9 and LDL-C. Elevated PCSK9 level is an independent risk factor so controlling its rise by statins may be important in prevention of cardiovascular events.

SUBMITTER: Ciric MZ

PROVIDER: S-EPMC8001635 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAggressive lipid lowering by high-dose statin treatment has been established for the secondary prevention of coronary artery disease (CAD). Regarding the low-density lipoprotein cholesterol (LDL-C) level, however, the "The lower is the better" concept has been controversial to date. We hypothesized that there is an optimal LDL-C level, i.e., a "threshold" value, below which the incidence of cardiovascular events is no longer reduced. We undertook a subanalysis of the REAL-CAD study to explore whether such an optimal target LDL-C level exists by a novel analysis procedure to verify the existence of a monotonic relationship.MethodsFor a total of 11,105 patients with CAD enrolled in the REAL-CAD study, the LDL-C level at 6 months after randomization and 5-year cardiovascular outcomes were assessed. We set the "threshold" value of the LDL-C level under which the hazards were assumed to be constant, by including an artificial covariate max (0, LDL-C - threshold) in the Cox model. The analysis was repeated with different LDL-C thresholds (every 10 mg/dl from 40 to 100 mg/dl) and the model fit was assessed by log-likelihood.ResultsFor primary outcomes such as the composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and unstable angina requiring emergency hospitalization, the model fit assessed by log-likelihood was best when a threshold LDL-C value of 70 mg/dl was assumed. And in the model with a threshold LDL-C ≥ 70 mg/dl, the hazard ratio was 1.07 (95% confidence interval 1.01-1.13) as the LDL-C increased by 10 mg/dl. Therefore, the risk of cardiovascular events decreased monotonically until the LDL-C level was lowered to 70 mg/dl, but when the level was further reduced, the risk was independent of LDL-C.ConclusionsOur analysis model suggests that a "threshold" value of LDL-C might exist for the secondary prevention of cardiovascular events in Japanese patients with CAD, and this threshold might be 70 mg/dl for primary composite outcomes.Trial registrationhttp://www.Clinicaltrialsgov . Unique identifier: NCT01042730.

Project description:BackgroundA couple of studies indicate a favorable impact of lupin protein on cardiovascular risk factors in humans. These studies, however, used relatively high doses of > 33 g/d, which can hardly be consumed under physiological conditions. Therefore, we investigated the effect of 25 g/d lupin protein isolate (LPI) on selected cardiovascular markers and on serum amino acids.MethodsA total of 33 hypercholesterolemic subjects participated in a randomized, controlled, double-blind crossover study. LPI and the active comparator milk protein isolate (MPI) were incorporated in protein drinks and consumed over 8 wk separated by a 4 wk washout period. Anthropometric data, blood pressure, and nutrient intake were assessed at baseline and after 8 wk of both protein interventions. Blood was sampled at baseline, wk 4 and wk 8. All 33 subjects were included in final statistical analyses using repeated measures ANOVA with the general linear model or using linear mixed model.ResultsExcept for higher HDL cholesterol at wk 4 of LPI (P ≤ 0.036), anthropometric parameters, blood pressure, and plasma lipids did not differ among LPI and MPI intervention. Compared to baseline, the primary outcome LDL cholesterol was significantly reduced after 4 wk of both interventions (P ≤ 0.008), while LDL:HDL cholesterol ratio was decreased only by LPI (P = 0.003). These time effects were restricted to subjects with higher hypercholesterolemia and disappeared after 8 wk. Blood pressure was reduced after 8 wk of LPI (P ≤ 0.044). Almost all serum amino acids were higher at wk 4 but not at wk 8 of MPI compared to LPI. Following 4 wk and 8 wk of LPI intervention, most amino acids remained unchanged. Both interventions caused a slight, but significant rise in body weight and body fat after 8 wk (P ≤ 0.045).ConclusionIn conclusion, 25 g LPI can beneficially modulate plasma LDL cholesterol at least over short-term. Using appropriate dietetic conditions that improve consumer compliance and avoid changes in energy intake as well as in body composition, lupin protein could positively impact cardiovascular risk factors particularly in individuals with higher hypercholesterolemia.Trial registrationClinicalTrials.gov: NCT01304992.

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Supplementation with Octacosanol Affects the Level of PCSK9 and Restore Its Physiologic Relation with LDL-C in Patients on Chronic Statin Therapy.

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