scholarly journals Impact of genetic testing on low-density lipoprotein cholesterol in patients with familial hypercholesterolemia (GenTLe-FH): a randomised waiting list controlled open-label study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023636 ◽  
Author(s):  
Akihiro Nomura ◽  
Hayato Tada ◽  
Hirofumi Okada ◽  
Atsushi Nohara ◽  
Hideki Ishikawa ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Genetic Testing ◽  
Familial Hypercholesterolemia ◽  
Genetic Counselling ◽  
Study Protocol ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Low Density ◽  
Low Density Lipoprotein Cholesterol ◽  
Open Label

IntroductionFamilial hypercholesterolemia (FH) is an autosomal-dominant inherited genetic disease. High-throughput sequencing quickly and comprehensively detects causative variants of FH-related genes (LDLR,PCSK9,APOBandLDLRAP1). Although the presence of causative variants in FH-related genes correlates with future cardiovascular events, it remains unclear whether detection of causative gene mutation and disclosure of its associated cardiovascular risk affects outcomes in patients with FH. Therefore, this study intends to evaluate the efficacy of counselling future cardiovascular risk based on genetic testing in addition to standard patients’ education programme in patients with FH.Methods and analysisA randomised, waiting-list controlled, open-label, single-centre trial will be conducted. We will recruit patients with clinically diagnosed FH without previous history of coronary heart disease from March 2018 to December 2019, and we plan to follow up participants until March 2021. For the intervention group, we will perform genetic counselling and will inform an estimated future cardiovascular risk based on individuals’ genetic testing results. The primary endpoint of this study is the plasma low-density lipoprotein cholesterol level at 24 weeks after randomisation. The secondary endpoints assessed at 24 and 48 weeks are as follows: blood test results; smoking status; changes of lipid-lowering agents’ regimen and Patients Satisfaction Questionnaire Short Form scores among the four groups divided by the presence of genetic counselling and genetic status of FH.Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects and all other applicable laws and guidelines in Japan. This study protocol was approved by the IRB at Kanazawa University. We will disseminate the final results at international conferences and in a peer-reviewed journal.Trial registration numberUMIN000029375.

scholarly journals Resveratrol improves the lipid profile promoted by red yeast rice (monacolin k) in patients with moderate dyslipidemia: An open-label, randomized, parallel-group controlled clinical trial

2017 ◽  
Vol 1 (1) ◽  
pp. 72-75
Author(s):  
Annalisa Panico ◽  
Gelsy Arianna Lupoli ◽  
Roberta Lupoli ◽  
Fiammetta Romano ◽  
Livia Barba ◽  
...  
Keyword(s):  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Low Density ◽  
Monacolin K ◽  
Low Density Lipoprotein Cholesterol ◽  
Open Label ◽  
Red Yeast ◽  
Parallel Group

Abstract Introduction: A relevant role is now emerging for nutraceuticals and specific functional foods in the treatment of dyslipidemia. The aim of this study was to evaluate the efficacy of a nutraceutical multi-target approach in subjects with moderate cardiovascular risk and to compare it with red yeast rice (RYR) treatment alone. Materials and Methods: Sixty patients with a first diagnosis of moderate dyslipidemia were included in a 6-week open-label, randomized, parallel-group controlled clinical trial and were treated with a nutraceutical supplement of Red Yeast Rice (RYR) extract containing 10 mg of monacolin k or its combination with 48 mg of an improved form of highly bioavailable resveratrol. The dosage of RYR was selected on the basis of its expected efficacy in reducing low-density lipoprotein- cholesterol also approved by the EFSA panel. All differences were assessed by Student’s t test with P values .05 are considered as statistically significant. Statistical analysis was performed by using Excel. Results: Treatment with RYR (10 mg monacolin K) led to a reduction of total cholesterol (20%) and low-density lipoprotein- cholesterol (21%). The combination with resveratrol however, compared to RYR alone significantly reduced triglyceride (-18 %) levels, systolic blood pressure (-2 %) and HOMA index (-17 %). Discussion: These results indicate that the nutraceutical supplementation of RYR associated with resveratrol not only shows lipid-lowering activity but compared to RYR treatment alone significantly also ameliorates other metabolic parameters. Thus, may represent a valid and safe approach, especially in people with moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate.

scholarly journals Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry

2019 ◽  
Vol 26 (8) ◽  
pp. 824-835 ◽  
Author(s):  
Kornelia Kotseva ◽  
Guy De Backer ◽  
Dirk De Bacquer ◽  
Lars Rydén ◽  
Arno Hoes ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Risk Factor ◽  
Cardiovascular Risk ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Cardiovascular Prevention ◽  
Lipoprotein Cholesterol ◽  
Low Density ◽  
Low Density Lipoprotein Cholesterol ◽  
Coronary Patients

Aims The aim of this study was to determine whether the Joint European Societies guidelines on secondary cardiovascular prevention are followed in everyday practice. Design A cross-sectional ESC-EORP survey (EUROASPIRE V) at 131 centres in 81 regions in 27 countries. Methods Patients (<80 years old) with verified coronary artery events or interventions were interviewed and examined ≥6 months later. Results A total of 8261 patients (females 26%) were interviewed. Nineteen per cent smoked and 55% of them were persistent smokers, 38% were obese (body mass index ≥30 kg/m2), 59% were centrally obese (waist circumference: men ≥102 cm; women ≥88 cm) while 66% were physically active <30 min 5 times/week. Forty-two per cent had a blood pressure ≥140/90 mmHg (≥140/85 if diabetic), 71% had low-density lipoprotein cholesterol ≥1.8 mmol/L (≥70 mg/dL) and 29% reported having diabetes. Cardioprotective medication was: anti-platelets 93%, beta-blockers 81%, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers 75% and statins 80%. Conclusion A large majority of coronary patients have unhealthy lifestyles in terms of smoking, diet and sedentary behaviour, which adversely impacts major cardiovascular risk factors. A majority did not achieve their blood pressure, low-density lipoprotein cholesterol and glucose targets. Cardiovascular prevention requires modern preventive cardiology programmes delivered by interdisciplinary teams of healthcare professionals addressing all aspects of lifestyle and risk factor management, in order to reduce the risk of recurrent cardiovascular events.

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