Evidence-based data on Simvastatin: A 15-year experience

2010 ◽  
Vol 16 (3) ◽  
pp. 238-249
Author(s):  
A. V. Susekov ◽  
N. B. Gornyakova ◽  
M. Y. Zubareva ◽  
S. A. Boitsov

Inhibitors of 3-hydroxy-3-methyl-glutaryl-CoA (HMG-Ko-A) reductase (statins) are widely used in treatment hyperlipideamia and atherosclerosis for more than 30 years. Results of randomized controlled trials studying statins have demonstrated that for each 1 % reduction of low-density lipoprotein (LDL) one can achieve 0,88 % reduction of cardiovascular risk. Simvastain (Zocor™) is the fi rst-generation semisynthetic statin registered by FDA in 1988. Over the past 15 years simvastatin has been widely studied in clinical trials with hard end points (4S, HPS, IDEAL, ACCORD). These trials showed that treatment with Simvastatin 20-40 mg/day may signifi cantly reduce risk of cardiovascular death by 24-35 %, coronary death - by 42 %, risk of stroke - by 27 % and total mortality - by 13-30 %. Simvastatin was also well studied in regression trials (FHRS, MAAS and CIS). Simvastatin - is the best-investigated statin in terms of long-term safety and tolerability. In particular, in HPS study the incidence of liver damage did not exceeded 0,1 %, myopathy - 0,05 %. Zocor is well studied in combination therapy with fi brates, niacin and ezetimibe. Fixed drug combination ezetemibe 10 mg/sim vastatin 20 mg may reduce LDL for more than 50 %, most of high-risk patients can achieve target LDL-C goals. According to DYSIS study (2009) simvastatin is the most reliable and widely used statin in the world.

2017 ◽  
Vol 22 (4) ◽  
pp. 956-968 ◽  
Author(s):  
Laura M. Koppen ◽  
Andrea Whitaker ◽  
Audrey Rosene ◽  
Robert D. Beckett

The objective of this review is to identify, summarize, and evaluate clinical trials of berberine for the treatment of hyperlipidemia and other dyslipidemias. A literature search for randomized, controlled trials of berberine that assessed at least 2 lipid values as endpoints resulted in identification of 12 articles that met criteria. The majority of evaluated articles consistently suggest that berberine has a beneficial effect on low-density lipoprotein (reductions ranging from approximately 20 to 50 mg/dL) and triglycerides (reductions ranging from approximately 25 to 55 mg/dL). Common study limitations included lack of reporting of precision in their endpoints, description of blinding, transparency in flow of patients, and reporting of baseline concomitant medications. Berberine could serve as an alternative for patients who are intolerant to statins, patients resistant to starting statin therapy but who are open to alternative treatments, and for low-risk patients not indicated for statin therapy.


Author(s):  
Reagan F. Cabahug

Reduction in coronary events rates in high-risk patients is feasible by altering cardiovascular risk factors. In the US and most European Countries, the leading cause of death is coronary heart disease (CHD). Hypercholesterolemia is the principal risk factor for coronary artery disease. High-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) are significant risk factors for CHD [1]. Hydroxymethylglutaryl-CoA (HMG-Co-A) inhibitors are the most effective treatment of cutting LDL-C levels with a subsequent reduction in cardiovascular death and morbidity. A nudge happens when a choice architecture is planned to control behaviour predictably without curbing an individual’s choice [2]. For a nudge to be influential, the direction and force should be in line with professional standards. The article detailed how patients' and physicians' actions contributed to the increasing incidence of cardiovascular diseases. Nudges either digital or  manual (use of post-it) can be useful in influencing physicians to be proactive and can increase patients’ adherence to the therapy. Trust between the patient and the physician is crucial in attaining these goals. Nudges can be a valuable management tool for steering correct behaviours among healthcare providers. The technique is to ensure that physicians see them as something constructive and not irritating or controlling noodges.


Author(s):  
Franziska Grundler ◽  
Dietmar Plonné ◽  
Robin Mesnage ◽  
Diethard Müller ◽  
Cesare R. Sirtori ◽  
...  

Abstract Purpose Dyslipidemia is a major health concern associated with an increased risk of cardiovascular mortality. Long-term fasting (LF) has been shown to improve plasma lipid profile. We performed an in-depth investigation of lipoprotein composition. Methods This observational study included 40 volunteers (50% men, aged 32–65 years), who underwent a medically supervised fast of 14 days (250 kcal/day). Changes in lipid and lipoprotein levels, as well as in lipoprotein subclasses and particles, were measured by ultracentrifugation and nuclear magnetic resonance (NMR) at baseline, and after 7 and 14 fasting days. Results The largest changes were found after 14 fasting days. There were significant reductions in triglycerides (TG, − 0.35 ± 0.1 mmol/L), very low-density lipoprotein (VLDL)-TG (− 0.46 ± 0.08 mmol/L), VLDL-cholesterol (VLDL-C, − 0.16 ± 0.03 mmol/L) and low-density lipoprotein (LDL)-C (− 0.72 ± 0.14 mmol/L). Analysis of LDL subclasses showed a significant decrease in LDL1-C (− 0.16 ± 0.05 mmol/L), LDL2-C (− 0.30 ± 0.06 mmol/L) and LDL3-C (− 0.27 ± 0.05 mmol/L). NMR spectroscopy showed a significant reduction in large VLDL particles (− 5.18 ± 1.26 nmol/L), as well as large (− 244.13 ± 39.45 nmol/L) and small LDL particles (− 38.45 ± 44.04 nmol/L). A significant decrease in high-density lipoprotein (HDL)-C (− 0.16 ± 0.04 mmol/L) was observed. By contrast, the concentration in large HDL particles was significantly raised. Apolipoprotein A1 decreased significantly whereas apolipoprotein B, lipoprotein(a), fibrinogen and high-sensitivity C-reactive protein were unchanged. Conclusion Our results suggest that LF improves lipoprotein levels and lipoprotein subclasses and ameliorates the lipoprotein-associated atherogenic risk profile, suggesting a reduction in the cardiovascular risk linked to dyslipidemia. Trial Registration Study registration number: DRKS-ID: DRKS00010111 Date of registration: 03/06/2016 “retrospectively registered”.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Endo ◽  
Y Kagawa ◽  
H Sato ◽  
Y Morita ◽  
H Kawahara ◽  
...  

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


2013 ◽  
Vol 24 (3) ◽  
pp. 437-441 ◽  
Author(s):  
Avishay Elis ◽  
Rong Zhou ◽  
Evan A. Stein

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.


2021 ◽  
Vol 13 (1) ◽  
pp. 14-20
Author(s):  
Marisa Santos ◽  
◽  
Quenia Morais ◽  
Helena Cramer ◽  
Marcelo Assad ◽  
...  

Objective: Familial hypercholesterolaemia is a hereditary disease characterized by very high levels of low-density lipoprotein cholesterol and an elevated risk of early-onset cardiovascular disorders. New drugs provide alternatives for the treatment of patients with homozygous familial hypercholesterolaemia. The study aims to explore a practical application of multiple-criteria decision analysis on prioritization of new and emerging technologies for familial hypercholesterolaemia. Methods: The decision model was constructed using the MACBETH method. There were three stages: structuring the problem, measuring the performance of alternatives, and building the model. The weights for alternatives and levels were obtained by indirect comparisons, which evaluated the attractiveness of the performance levels of the criteria using the swing weights technique. Results: The drugs lomitapide, ezetimibe, evolocumab, and mipomersen were selected as alternatives for decision-making. “Cardiovascular Death”, “Stroke” and “Acute Myocardial Infarction” had the three most significant weights. The criteria with the lowest weights were “Comfort” and “LDL-C Reduction”. The top-ranked technology was evolocumab, with an overall score of 59.87, followed by ezetimibe, with a score of 37.21. Conclusion: How to apply the result of a higher score in the actual decisionmaking process still requires further studies. The case in question showed that evolocumab has more performance benefits than other drugs but with a cost approximately 50 times higher


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