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To study impact of treatment with Rosuvastatin versus Atorvastatin on 25 hydroxy Vitamin D concentrations among adult Indian men- a randomized control trial.
Patwardhan, VG, Mughal, ZM, Padidela, R, Chiplonkar, SA, Khadilkar, VV, Khadilkar, AV
Indian journal of pharmacology. 2020;(5):365-371
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Abstract
BACKGROUND Dyslipidemias are on the rise and are increasingly being treated with statins. As the metabolism of cholecalciferol and cholesterol are interrelated, reduction in cholesterol synthesis by statins is likely to affect Vitamin D status. OBJECTIVES (1) The aim is to study the effect of treatment with statins (Atorvastatin/Rosuvastatin) on 25-hydroxy-Vitamin-D (25OHD) among newly detected subjects with dyslipidemia for 6 months (2) To study the impact of 25OHD concentrations on the efficacy of statin treatment. MATERIALS AND METHODS This was a prospective, balanced randomized (1:1), open-label, parallel-group study, in apparently healthy Indian adult men (south Asian, 40-60 years). At baseline, serum lipids and 25OHD concentrations were measured. Based on the Adult Treatment Panel III guidelines, subjects were divided as per lipid concentrations into controls (who did not require statin treatment) and intervention (who required statin treatment) groups. Random allocation of subjects was done in two groups for receiving intervention for 6 months: Atorvastatin group (n = 52, received Atorvastatin) or Rosuvastatin group (n = 52, received Rosuvastatin). Lipids and 25OHD concentrations were measured at the end line. RESULTS Atorvastatin group presented significant reduction (P < 0.05) in 25OHD, total cholesterol (TC) and low-density-lipoprotein-cholesterol (LDL-C) concentrations at the end line. In the Rosuvastatin group, significant drop in TC, LDL-C and high-density lipoprotein cholesterol (concentrations (P < 0.05) was observed, while 25OHD concentrations showed no significant change. Mean 25OHD concentrations were significantly correlated with a reduction in LDL-C concentrations in Atorvastatin group. CONCLUSIONS Treatment with Atorvastatin resulted in a reduction in 25OHD concentrations; further, its efficacy in reducing LDL-C concentrations was related to the 25OHD concentrations.
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Effects of different doses of atorvastatin, rosuvastatin, and simvastatin on elderly patients with ST-elevation acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI).
He, W, Cao, M, Li, Z
Drug development research. 2020;(5):551-556
Abstract
OBJECTIVE To conduct a randomized double-blind prospective study to investigate effect of different doses of atorvastatin, rosuvastatin, and simvastatin on elderly patients with ST-elevation AMI after PCI. METHODS One hundred and ninety-two AMI patients over 60 years old who underwent PCI were randomly divided into six groups: the low atorvastatin group, high atorvastatin group; low rosuvastatin group; high rosuvastatin group; low simvastatin group; high simvastatin group. Demographic data and clinical information as well as coronary angiography parameters were recorded. Plasma levels of CK-MB, BNP, ALT, and TnI were measured at 12 hr, 24 hr, and 1 week after PCI. Major cardiovascular events (MACE) were recorded and analyzed using Kaplan-Meier (K-M) curve. RESULTS No significant differences were observed in angiographic and procedural characteristics. In all high dose groups, all levels of CK-MB, BNP, ALT, and TnI were significantly lower. However, after 1 week of PCI, only CK-MB, BNP, and TnI showed significant difference between high and low dose groups. Patients in high dose groups had significantly lower rates for surgical or percutaneous intervention, recurrence of angina, and rehospitalization. K-M curve analysis also showed cumulative incidence freedom time of overall MACE in high dose groups was significantly longer. No significant differences were found among different drugs with the same doses. CONCLUSION Patients with higher doses had lower level of CK-MB, BNP, ALT, and TnI and lower occurrence of MACE after PCI.
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Circulatory and prostatic tissue lipidomic profiles shifts after high-dose atorvastatin use in men with prostate cancer.
Raittinen, P, Niemistö, K, Pennanen, E, Syvälä, H, Auriola, S, Riikonen, J, Lehtimäki, T, Ilmonen, P, Murtola, T
Scientific reports. 2020;(1):12016
Abstract
Prostate cancer patients using cholesterol-lowering statins have 30% lower risk of prostate cancer death compared to non-users. The effect is attributed to the inhibition of the mevalonate pathway in prostate cancer cells. Moreover, statin use causes lipoprotein metabolism changes in the serum. Statin effect on serum or intraprostatic lipidome profiles in prostate cancer patients has not been explored. We studied changes in the serum metabolomic and prostatic tissue lipidome after high-dose 80 mg atorvastatin intervention to expose biological mechanisms causing the observed survival benefit. Our randomized, double-blind, placebo-controlled clinical trial consisted of 103 Finnish men with prostate cancer. We observed clear difference in post-intervention serum lipoprotein lipid profiles between the study arms (median classification error 11.7%). The atorvastatin effect on intraprostatic lipid profile was not as clear (median classification error 44.7%), although slightly differing lipid profiles by treatment arm was observed, which became more pronounced in men who used atorvastatin above the median of 27 days (statin group median classification error 27.2%). Atorvastatin lowers lipids important for adaptation for hypoxic microenvironment in the prostate suggesting that prostate cancer cell survival benefit associated with statin use might be mediated by both, local and systemic, lipidomic/metabolomic profile changes.
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Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Jun, JE, Jeong, IK, Yu, JM, Kim, SR, Lee, IK, Han, KA, Choi, SH, Kim, SK, Park, HK, Mok, JO, et al
Diabetes & metabolism journal. 2020;(1):78-90
Abstract
BACKGROUND Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia. METHODS This randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment. RESULTS After 8 weeks of treatment, the percent changes from baseline in TG (-29.8% vs. 3.6%, P<0.001) and non-HDL-C (-10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups. CONCLUSION The addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.
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Comparison between Atorvastatin and Rosuvastatin on Secondary Percutaneous Coronary Intervention Rate and the Risk Factors in Patients with Coronary Heart Disease.
Zhang, J, Wang, J, Yu, H, Wang, G, Zhang, J, Zhu, R, Liu, X, Li, J
Current drug metabolism. 2020;(10):818-828
Abstract
OBJECTIVE The aim is to compare atorvastatin versus rosuvastatin on secondary percutaneous coronary intervention (PCI) rate and explore risk factors in coronary heart disease (CHD) patients. METHODS A cohort study with 283 CHD subjects was launched from 2011 to 2015. Cox proportional hazards regression model, Receiver Operating Characteristic (ROC) and nomogram were used to compare the effect of atorvastatin and rosuvastatin on secondary PCI rate and disease risk factors. Even why the two statins had different effects based on gene expression profile analysis has been explored. RESULTS Gene FFA (Freely fatty acid), AST (Aspartate Transaminase) and ALT (Alanine transaminase) showed the statistical difference between the four statin groups (P<0.05). In the AA group (Continuous Atorvastatin usage), albumin was a risk factor (Hazard Ratio (HR):1.076, 95%CI (1.001, 1.162), p<0.05). In the AR group (Start with Atorvastatin usage, then change to Rosuvastatin usage), ApoA was a protective factor (HR:0.004, 95%CI (0.001, 0.665), p<0.05). GLB (Galactosidase Beta) was a risk factor (HR:1.262, 95%CI (1.010, 1.576), p<0.05). In RR group (Continuous Rosuvastatin usage), ApoE was a protective factor (HR:0.943, 95%CI (0.890, 1.000), <0.05). ALT was a risk factor (HR:1.030, 95%CI (1.000, 1.060), p<0.05). CONCLUSION Patients in the RA group had the lowest secondary PCI rate. ALT was a risk factor in the RR group. Gene Gpt (Glutamic Pyruvic Transaminase) encoded for one subtype of ALT had a significantly different expression in different statin groups.
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Individual coronary plaque changes on serial CT angiography: Within-patient heterogeneity, natural history, and statin effects in HIV.
Foldyna, B, Lo, J, Mayrhofer, T, Grinspoon, SK, Hoffmann, U, Lu, MT
Journal of cardiovascular computed tomography. 2020;(2):144-148
Abstract
BACKGROUND It is not known how the volume and composition of individual coronary plaques change over time in HIV-infected people and whether statins influence these changes. METHODS We included forty adults with HIV and subclinical coronary atherosclerosis who participated in a randomized controlled trial of placebo vs. atorvastatin. All participants underwent serial coronary computed tomography angiography at baseline and after one year. Individual coronary plaques were measured to assess the within-patient variability of plaque volume and composition changes. Left-main, proximal-right, proximal-left-anterior descending, and proximal-circumflex coronary segments were considered proximal. Plaque voxels with attenuation ≤130 Hounsfield Units (HU) were defined as noncalcified and further divided into fatty (<40HU) and fibrotic (40-130HU) components. RESULTS In 37 patients who completed the trial, there were 92 coronary plaques. Individual plaque changes varied highly, with some plaques increasing while others decreased in the same patient. Overall, 77% vs. 51% of individual plaques progressed, while 24% vs. 49% regressed in placebo and statin, respectively (p = 0.016). Substantial increases in proximal plaques drove the progression in placebo. Statins suppressed these large increases, resulting in a 3-fold lower variance in plaque volume change compared to placebo (p = 0.025). Statins suppressed progression of fibrotic (p = 0.015) plaque, with a trend towards reducing fatty (p = 0.075) plaque and no significant effect on the calcified portion (p = 0.203). CONCLUSION In persons with HIV, a population with increased atherosclerosis burden and cardiovascular risk, individual coronary plaque changes vary within a given individual. Large increases in proximal plaques characterize progression, and statins act in part by stabilizing progressing plaques by reducing fatty and fibrotic plaque components, without influencing the calcified portion.
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Influence of Statins on Circulating Inflammatory Cytokines in Patients With Abnormal Glucose Homeostasis: A Meta-analysis of Data From Randomized Controlled Trials.
Milajerdi, A, Sadeghi, A, Mousavi, SM, Larijani, B, Esmaillzadeh, A
Clinical therapeutics. 2020;(2):e13-e31
Abstract
PURPOSE Chronic inflammation increases the risks for cardiovascular disease, type 2 diabetes, and cancer. Recently, the antiinflammatory effects of statins, as cholesterol-lowering medications, have been considered. This study systematically reviewed and summarized earlier findings from randomized clinical trials about the effects of statins on serum concentrations of C-reactive protein (CRP) and interleukin (IL)-6 in patients with abnormal glucose homeostasis. METHODS Relevant articles published through October 2019 were searched using suitable key words on the PubMed/MEDLINE, SCOPUS, EMBASE, and Google Scholar databases. RCTs were included if they compared the effects of statins on serum concentrations of CRP and IL-6 in adults with abnormal glucose homeostasis. The effect sizes were represented as weighted mean differences (WMDs) and 95% CI s using a random-effects model. Subgroup analysis was performed to find possible sources of heterogeneity. FINDINGS Overall, 17 publications with 21 effect sizes and which enrolled 3766 subjects (1895 participants in intervention and 1871 in control groups) were included. Combining 13 effect sizes from 10 studies, a significant reduction in serum CRP concentration following the administration of atorvastatin was found (WMD, -0.35; 95% CI, -0.54 to -0.17; I2 = 90.6%). Based on 5 effect sizes from 4 studies, we found a statistically significant reduction in serum IL-6 concentration after atorvastatin therapy (WMD, -0.44; 95% CI, -0.65 to -0.22; I2 = 93.9%). Pooling 6 effect sizes from 5 studies revealed a significantly reduced serum concentration of CRP after simvastatin therapy (WMD, -0.66; 95% CI, -0.79 to -0.54; I2 = 97.6%). IMPLICATIONS The administration of atorvastatin or simvastatin in patients with abnormal glucose hemostasis was associated with a reduced serum CRP concentration. Atorvastatin therapy might also help to decrease serum IL-6 concentration in these patients.
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Atorvastatin Reduces First and Subsequent Vascular Events Across Vascular Territories: The SPARCL Trial.
Szarek, M, Amarenco, P, Callahan, A, DeMicco, D, Fayyad, R, Goldstein, LB, Laskey, R, Sillesen, H, Welch, KM, ,
Journal of the American College of Cardiology. 2020;(17):2110-2118
Abstract
BACKGROUND In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, atorvastatin was compared with placebo in 4,731 participants with recent stroke or transient ischemic attack and no known coronary heart disease. Atorvastatin reduced the first occurrence of stroke and the first occurrence of a composite of vascular events. OBJECTIVES The aim of this post hoc analysis was to assess the occurrence of all (first and subsequent) vascular events and the effect of atorvastatin to reduce these events by vascular territory (cerebrovascular, coronary, or peripheral) in SPARCL. METHODS Treatment effects on total adjudicated vascular events, overall and by vascular territory, were summarized by marginal proportional hazards models. Vascular event rates were estimated for each treatment group with cumulative incidence functions. RESULTS The placebo group had an estimated 41.2 first and 62.7 total vascular events per 100 participants over 6 years. There were 164 fewer first and 390 fewer total vascular events in the atorvastatin group (total events hazard ratio: 0.68; 95% confidence interval: 0.60 to 0.77). The total events reduction included 177 fewer cerebrovascular, 170 fewer coronary, and 43 fewer peripheral events. Over 6 years, an estimated 20 vascular events per 100 participants were avoided with atorvastatin treatment. CONCLUSIONS In participants with recent stroke or transient ischemic attack, the total number of vascular events prevented with atorvastatin was more than twice the number of first events prevented. Total event reduction provides a comprehensive metric to capture the totality of atorvastatin clinical efficacy in reducing disease burden after stroke or transient ischemic attack. (Lipitor in the Prevention of Stroke, for Patients Who Have Had a Previous Stroke [SPARCL]; NCT00147602).
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The Effect of Atorvastatin on Vascular Function and Structure in Young Adult Survivors of Childhood Cancer: A Randomized, Placebo-Controlled Pilot Clinical Trial.
Marlatt, KL, Steinberger, J, Rudser, KD, Dengel, DR, Sadak, KT, Lee, JL, Blaes, AH, Duprez, DA, Perkins, JL, Ross, JA, et al
Journal of adolescent and young adult oncology. 2019;(4):442-450
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Abstract
Purpose: Many adult survivors of childhood cancer are at high-risk of developing cardiovascular disease. Cancer therapy may cause damage to the vascular endothelium, thereby initiating atherosclerosis. Atorvastatin has been shown to improve endothelial function independent of reducing cholesterol, as well as reduce/slow arterial stiffness and thickening, yet has never been studied in childhood cancer survivors (CCS). Methods: Twenty-seven young adult (age 26.8 ± 6.2 years) survivors of childhood acute lymphoblastic leukemia or Non-Hodgkin's lymphoma were randomly assigned (1:1) 40 mg/day of atorvastatin or placebo for 6 months. Brachial artery flow-mediated dilation (FMD), small artery reactive hyperemia index (RHI), arterial stiffness, and carotid artery elasticity/thickness were assessed. Results: Fifteen participants completed the trial. No significant treatment effect for any vascular outcomes was observed at 6 months; however, a significant decrease in peak FMD (-3.0 [95% confidence interval [CI]: -5.3, -0.7]) and a trending significant decrease in RHI (-0.3 [95% CI: -0.62, 0.01]) was observed in the placebo group, resulting in a trend toward a treatment effects (p < 0.10). No effect on arterial stiffness, carotid arterial elasticity, or thickness was observed. Conclusion: Six months of atorvastatin treatment did not improve endothelial function or arterial stiffness in young adult CCS. While a trend toward an improvement in endothelial function was present, findings should be interpreted with caution owing to the small number of evaluable participants and subsequent lack of sufficient power. Further research in a larger sample size is needed to fully elucidate the effects of atorvastatin on vascular function. Trial registered at clinicaltrials.gov as NCT01733953.
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Prophylactic atorvastatin prior to intra-arterial administration of iodinated contrast media for prevention of contrast-induced acute kidney injury: A meta-analysis of randomized trial data
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Sun, YY, Liu, LY, Sun, T, Wu, MY, Ma, FZ
Clinical nephrology. 2019;(3):123-130
Abstract
BACKGROUND The efficacy of high-dose atorvastatin pretreatment in reducing the incidence of contrast-induced nephropathy in patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI) has been examined in some randomized studies. However, the results across the trials remain controversial. OBJECTIVE This study sought to perform a meta-analysis to evaluate the effect of high-dose atorvastatin in the prevention of contrast-induced nephropathy (CIN) while undergoing CAG or PCI. MATERIALS AND METHODS Comprehensive literature searches for randomized controlled trials (RCTs) comparing high-dose atorvastatin vs. low-dose statin or placebo pretreatment for prevention of contrast-induced acute kidney injury in patients undergoing CAG were performed using PubMed, Embase, and the Cochrane library updated to June 2017. The primary outcome was the incidence of CIN. RESULTS A total of 11 RCTs were included in this analysis. The high-dose atorvastatin treatment can significantly reduce the incidence of CIN (OR 0.46, 95% CI 0.35 - 0.62, p < 0.00001). The benefit was consistent in comparison with the low-dose group (OR 0.41, 95% CI 0.25 - 0.66, p = 0.0003) and the placebo group (OR 0.50, 95% CI 0.26 - 0.98, p = 0.04). CONCLUSION Our study demonstrates that high-dose statin pretreatment shows a benefit specifically in reducing the incidence of contrast-induced acute kidney injury in patients undergoing CAG, especially compared with low-dose statin pretreatment.