scholarly journals Analysis of Safety from a Human Clinical Trial with Pterostilbene

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Daniel M. Riche ◽  
Corey L. McEwen ◽  
Krista D. Riche ◽  
Justin J. Sherman ◽  
Marion R. Wofford ◽  
...  
Keyword(s):  
Mixed Models ◽  
Biochemical Analysis ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Intervention Trial ◽  
Human Clinical Trial ◽  
Low Density Lipoprotein Cholesterol ◽  
Double Blind ◽  
Baseline Total Cholesterol

Objectives. The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans.Methodology. The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ≥200 mg/dL and/or baseline low-density lipoprotein cholesterol ≥100 mg/dL). Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125 mg twice daily, (2) pterostilbene 50 mg twice daily, (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily, and (4) matching placebo twice daily for 6–8 weeks. Safety markers included biochemical and subjective measures. Linear mixed models were used to estimate primary safety measure treatment effects.Results. The majority of patients completed the trial (91.3%). The average age was 54 years. The majority of patients were females (71%) and Caucasians (70%). There were no adverse drug reactions (ADRs) on hepatic, renal, or glucose markers based on biochemical analysis. There were no statistically significant self-reported or major ADRs.Conclusion. Pterostilbene is generally safe for use in humans up to 250 mg/day.

scholarly journals Effectiveness of more strict managements after achievement of standard target value of low-density lipoprotein cholesterol in secondary prevention of Japanese patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Endo ◽  
Y Kagawa ◽  
H Sato ◽  
Y Morita ◽  
H Kawahara ◽  
...  
Keyword(s):  
Secondary Prevention ◽  
Coronary Revascularization ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Japanese Patients ◽  
Cardiac Ischemia ◽  
Low Density Lipoprotein Cholesterol ◽  
Standard Management ◽  
Coronary Events

Abstract Background In secondary prevention of coronary artery disease, target value of low-density lipoprotein cholesterol (LDL-C) <100 mg/dL is recommended as standard management in Japanese guideline. The guideline also stated that strict management of LDL-C targeting <70 mg/dL is considered in some high risk patients. However, in Japanese patients, effectiveness of more strict management of LDL-C lowering therapy for prevention of long-term cardiovascular events remains unclear. Purpose The purpose of the present study was to evaluate whether the strict management of LDL-C targeting <70 mg/dL was effective to prevent recurrence of long-term coronary events than standard management in patients with previous percutaneous coronary intervention (PCI). Methods We investigated 344 patients with previous PCI who underwent late coronary angiography to examine recurrence of cardiac ischemia beyond the early phase of restenosis from January 2007 to August 2019. Patients were stratified into three groups according to achieved LDL-C value; LDL-C <70mg/dL (n=53), 70 to <100mg/dL (n=130) and ≥100mg/dL (n=161). Endpoints of this study were recurrence of cardiac ischemia presenting as acute coronary syndrome (recurrence-ACS) and any late coronary revascularization. Results During average 7.1 years follow-up, 200 patients (58%) underwent any late coronary revascularization. In 94 of those patients, recurrence-ACS was observed. The incidence of recurrence-ACS was significantly lower in patients with achieved LDL-C <70mg/dL than in those with LDL-C 70 to <100mg/dL and LDL-C ≥100mg/dL (p=0.009 and p=0.001, respectively), however, there was no difference between patients with LDL-C 70 to <100mg/dL and LDL-C ≥100mg/dL (p=0.140). Any late revascularization was significantly lower in patients with achieved LDL-C <70mg/dL and in those with LDL-C 70 to <100mg/dL than in those with LDL-C ≥100mg/dL (p=0.002 and p<0.001, respectively), however, no difference was found between patients with LDL-C <70mg/dL and LDL-C 70 to <100mg/dL (p=0.119). Moreover, in patients with achieved LDL-C <100mg/dL (n=183), multivariate analysis identified that LDL-C (HR 1.035, p=0.007) and HbA1c (HR 1.338, p=0.001) were independent predictors of recurrence-ACS. In contrast, only using statins (HR 0.461, p=0.009) was an independent predictor of recurrence-ACS in patients with achieved LDL-C ≥100mg/dL. Conclusions LDL-C was the important residual risk of recurrence-ACS even after recommended standard LDL-C lowering management had been achieved. More strict management of LDL-C targeting to <70mg/dL should be considered to prevent recurrence-ACS for wider range of Japanese patients in secondary prevention. Incidence of late coronary events Funding Acknowledgement Type of funding source: None

Treatment of familial hypercholesterolaemia in children and adolescents in the last three decades

2013 ◽  
Vol 24 (3) ◽  
pp. 437-441 ◽  
Author(s):  
Avishay Elis ◽  
Rong Zhou ◽  
Evan A. Stein
Keyword(s):  
Children And Adolescents ◽  
Familial Hypercholesterolaemia ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Low Density ◽  
Low Density Lipoprotein Cholesterol ◽  
Cholesterol Levels ◽  
Heterozygous Familial Hypercholesterolaemia

AbstractBackground:This study evaluated the effectiveness of long-term intensive lipid-lowering therapy in children and adolescents with familial hypercholesterolaemia.Methods:The charts of 89 children and adolescents with heterozygous familial hypercholesterolaemia among ∼1000 patients treated from 1974 to 2008 were reviewed. Familial hypercholesterolaemia was defined as low-density lipoprotein cholesterol level >90th percentile in individuals with a history of familial hypercholesterolaemia.Results:Of the 89 patients, 51% were male; the mean age at diagnosis was 8 ± 4 years, and the mean follow-up was 13 ± 8 years. Baseline and most recent low-density lipoprotein cholesterol levels (mg/dl) under treatment were 250 ± 50 and 142 ± 49, respectively, reduced 43% from baseline (p < 0.0001). At the most recent visit, 39 patients received statin monotherapy, mainly atorvastatin or rosuvastatin, and 50 (56%) patients received combination therapy, mainly vytorin or rosuvastain/ezetimibe, 15 patients were >30 years of age, and none developed symptomatic cardiovascular disease or needed revascularisation.Conclusions:Long-term statin-based therapy can reduce low-density lipoprotein cholesterol levels in most children and adolescents with heterozygous familial hypercholesterolaemia and decrease cardiovascular risk significantly.

Karate Training Improves Metabolic Health in Overweight and Obese Adolescents: A Randomized Clinical Trial

2021 ◽  
pp. 1-11
Author(s):  
Fabricio de Souza ◽  
Luciano Acordi da Silva ◽  
Gisele Santinoni Ferreira ◽  
Márcia Mendonça Marcos de Souza ◽  
Franciane Bobinski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Overweight And Obesity ◽  
Lipoprotein Cholesterol ◽  
Psychological Interventions ◽  
Long Term Effects ◽  
Low Density Lipoprotein Cholesterol ◽  
Stress Markers

Purpose: This study evaluated the effects of 12 weeks of karate training on cardiometabolic parameters, oxidative stress, and inflammation in adolescents with overweight and obesity. Method: Seventy adolescents were randomized into 2 groups: control received nutritional and psychological interventions once a week for 12 weeks, and treatment received nutritional and psychological interventions once a week, plus 3 karate sessions per week, for 12 weeks. The main outcome measure was improvement in cardiometabolic parameters, oxidative stress, and inflammation. Results: After the intervention period, the treatment group showed a reduction in resting heart rate (77.86 [10.89]), high-density lipoprotein cholesterol (40.86 [8.31]), and triglycerides (75.18 [32.29]) and an increase in low-density lipoprotein cholesterol (95.64 [42.53]) in relation to pretraining. Regarding oxidative stress markers, there was a reduction in protein carbonylation (0.07 [0.06]) and nitric oxide (1.39 [1.11]) and an increase in superoxide dismutase (0.68 [0.31]) and glutathione (0.11 [0.08]) compared with pretraining. With respect to inflammation, adiponectin increased (14.54 [5.36]) after the intervention when compared with preintervention. Conclusion: The study concluded that the intervention may improve cardiometabolic parameters, oxidative stress, and inflammation in adolescents with overweight and obesity. Long-term effects need to be evaluated.

scholarly journals Long-term Low-Density Lipoprotein Cholesterol–Lowering Efficacy, Persistence, and Safety of Evolocumab in Treatment of Hypercholesterolemia

2017 ◽  
Vol 2 (6) ◽  
pp. 598 ◽  
Author(s):  
Michael J. Koren ◽  
Marc S. Sabatine ◽  
Robert P. Giugliano ◽  
Gisle Langslet ◽  
Stephen D. Wiviott ◽  
...  
Keyword(s):  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Low Density ◽  
Low Density Lipoprotein Cholesterol ◽  
Cholesterol Lowering
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