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1.
[Efficacy and Safety of Rosuvastatin in Patients of Different Risk Groups of Developing Cardiovascular Diseases].
Drapkina, OM, Eliashevich, SO
Kardiologiia. 2015;(2):72-81
Abstract
The purpose of the review - analysis of randomized clinical trials to evaluate the efficacy and safety of rosuvastatin in respect of primary and secondary prevention of cardiovascular events, as well as in patients with acute coronary syndrome. As a primary pathogenetic therapy aimed at reducing the risk of cardiovascular disease and death from cardiovascular disease ischemic nature, used statins, which have both lipid-lowering and pleiotropic other positive properties. When analyzing the results of the comparative evaluation of different statins best performance indicators in primary and secondary prevention of cardiovascular events were at the rosuvastatin. The first drug is bioequivalent to the original rosuvastatin in Russia became mertenil company "Gedeon Richter". The therapeutic equivalence of mertenil is comparable with that of the original drug in patients of different groups at risk of developing cardiovascular complications (from low to very high). Mertenil can be regarded as an effective and safe drug from the group of statins for primary and secondary prevention of cardiovascular complications in patients of all risk groups.
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2.
Rosuvastatin Treatment for Preventing Contrast-Induced Acute Kidney Injury After Cardiac Catheterization: A Meta-Analysis of Randomized Controlled Trials.
Yang, Y, Wu, YX, Hu, YZ
Medicine. 2015;(30):e1226
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Abstract
We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the protective effects of rosuvastatin on contrast-induced acute kidney injury (CI-AKI) and major adverse cardiovascular events (MACEs) in patients undergoing cardiac catherization.PubMed, MEDLINE, Web of Science, EMBASE, ClinicalTrials.gov, and the Cochrane Central RCTs were searched for RCTs from inception to May 2015, to compare rosuvastatin for preventing CI-AKI with placebo treatment in patients undergoing cardiac catherization.Five RCTs with a total of 4045 patients involving 2020 patients pretreated with rosuvastatin and 2025 control patients were identified and analyzed. Patients treated with rosuvastatin had a 51% lower risk of CI-AKI compared with the control group based on a fixed-effect model (OR = 0.49, 95% CI = 0.37-0.66, P < 0.001), and showed a trend toward a reduced risk of MACEs (OR = 0.62, 95% CI = 0.36-1.07, P = 0.08). A subgroup analysis showed that studies with Jadad score ≥3 showed a significant reduction of CI-AKI (OR = 0.53, 95% CI, 0.38-0.73, P < 0.001). However, the risk of CI-AKI did not significantly differ in the studies with Jadad score <3 (OR = 0.54, 95% CI, 0.13-2.24, P = 0.40). In addition, the rosuvastatin treatment showed no effect for preventing CI-AKI in patients with chronic kidney disease (CKD) undergoing elective cardiac catherization (I = 0%, OR = 0.81, 95% CI = 0.41-1.61, P = 0.55).This updated meta-analysis demonstrated that preprocedural rosuvastatin treatment could significantly reduce the incidence of CI-AKI, with a trend toward a reduced risk of MACEs in patients undergoing cardiac catheterization. However, rosuvastatin treatment did not seem to be effective for preventing CI-AKI in CKD patients undergoing elective cardiac catheterization.
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A meta-analysis of randomized head-to-head trials for effects of rosuvastatin versus atorvastatin on apolipoprotein profiles.
Takagi, H, Umemoto, T, ,
The American journal of cardiology. 2014;(2):292-301
Abstract
To determine which statin will better improve the apolipoprotein (Apo) profiles (ApoA-I levels, ApoB levels, and ApoB/A-I ratios), we performed a meta-analysis of randomized head-to-head trials of rosuvastatin versus atorvastatin therapy. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched through December 2012 using Web-based search engines (PubMed and OVID). The search terms included "apolipoprotein," "rosuvastatin," "atorvastatin," "randomized," "randomly," and "randomization." Of 42 potentially relevant studies initially screened, 25 reports of randomized trials enrolling 14,283 patients were included. A pooled analysis for the percentage of changes in ApoA-I demonstrated a benefit of rosuvastatin versus atorvastatin in the comparison of all rosuvastatin/atorvastatin dose ratios (mean difference 2.97%, 3.39%, 5.77%, and 6.25%). For the percentage of changes in ApoB, a benefit was seen for rosuvastatin versus atorvastatin in the 1/1 (-6.06%) and 1/2 dose ratio (-1.80%). However, a benefit was seen for atorvastatin versus rosuvastatin in the 1/4 (2.38%) and 1/8 dose ratio (6.59%). The pooled analysis for the percentage of changes in the Apo B/A-I ratios demonstrated a benefit for rosuvastatin versus atorvastatin in the 1/1 (-7.22%) and 1/2 dose ratio (-3.51%), with no difference in the 1/4 dose ratio. In contrast, a benefit was seen for atorvastatin versus rosuvastatin in the 1/8 dose ratio (4.03%). In conclusion, rosuvastatin might increase Apo A-I levels at all dose ratios and decrease ApoB levels and ApoB/A-I ratios in the 1/1 and 1/2 dose ratio versus atorvastatin. Only higher dose atorvastatin appeared to be more effective for the reduction in ApoB levels (1/4 and 1/8 dose ratio) and Apo B/A-I ratios (1/8 dose ratio).
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Lipid-lowering efficacy of rosuvastatin.
Adams, SP, Sekhon, SS, Wright, JM
The Cochrane database of systematic reviews. 2014;(11):CD010254
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Abstract
BACKGROUND Rosuvastatin is one of the most potent statins and is currently widely prescribed. It is therefore important to know the dose-related magnitude of effect of rosuvastatin on blood lipids. OBJECTIVES Primary objective To quantify the effects of various doses of rosuvastatin on serum total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, non-HDL-cholesterol and triglycerides in participants with and without evidence of cardiovascular disease. Secondary objectives To quantify the variability of the effect of various doses of rosuvastatin.To quantify withdrawals due to adverse effects (WDAEs) in the randomized placebo-controlled trials. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 10 of 12, 2014 in The Cochrane Library, MEDLINE (1946 to October week 5 2014), EMBASE (1980 to 2014 week 44), Web of Science Core Collection (1970 to 5 November 2014) and BIOSIS Citation Index (1969 to 31 October 2014). No language restrictions were applied. SELECTION CRITERIA Randomized controlled and uncontrolled before-and-after trials evaluating the dose response of different fixed doses of rosuvastatin on blood lipids over a duration of three to 12 weeks. DATA COLLECTION AND ANALYSIS Two review authors independently assessed eligibility criteria for studies to be included and extracted data. WDAEs information was collected from the placebo-controlled trials. MAIN RESULTS One-hundred and eight trials (18 placebo-controlled and 90 before-and-after) evaluated the dose-related efficacy of rosuvastatin in 19,596 participants. Rosuvastatin 10 to 40 mg/day caused LDL-cholesterol decreases of 46% to 55%, when all the trials were combined using the generic inverse variance method. The quality of evidence for these effects is high. Log dose-response data over doses of 1 to 80 mg, revealed strong linear dose-related effects on blood total cholesterol, LDL-cholesterol and non-HDL-cholesterol. When compared to atorvastatin, rosuvastatin was about three-fold more potent at reducing LDL-cholesterol. There was no dose-related effect of rosuvastatin on blood HDL-cholesterol, but overall, rosuvastatin increased HDL by 7%. There is a high risk of bias for the trials in this review, which would affect WDAEs, but unlikely to affect the lipid measurements. WDAEs were not statistically different between rosuvastatin and placebo in 10 of 18 of these short-term trials (risk ratio 0.84; 95% confidence interval 0.48 to 1.47). AUTHORS' CONCLUSIONS The total blood total cholesterol, LDL-cholesterol and non-HDL-cholesterol-lowering effect of rosuvastatin was linearly dependent on dose. Rosuvastatin log dose-response data were linear over the commonly prescribed dose range. Based on an informal comparison with atorvastatin, this represents a three-fold greater potency. This review did not provide a good estimate of the incidence of harms associated with rosuvastatin because of the short duration of the trials and the lack of reporting of adverse effects in 44% of the placebo-controlled trials.
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Statin wars: the heavyweight match--atorvastatin versus rosuvastatin for the treatment of atherosclerosis, heart failure, and chronic kidney disease.
DiNicolantonio, JJ, Lavie, CJ, Serebruany, VL, O'Keefe, JH
Postgraduate medicine. 2013;(1):7-16
Abstract
Statins are a standard of care in many clinical settings, especially for dyslipidemia management, and are used for the primary and secondary prevention of cardiovascular disease. Importantly, not all statins are born equal. The statin class consists of a number of heterogenous drugs, which vary in properties such as potency in lowering low-density lipoprotein cholesterol levels, lipophilicity, renoprotection, increasing high-density lipoprotein cholesterol levels, lowering triglyceride levels, and effects on glucose metabolism and myocardial function. It remains unclear whether these differences significantly impact clinical outcomes or if 1 statin should be preferred over another. This review summarizes the properties of the 2 most potent statins available (atorvastatin and rosuvastatin), as well as assesses the comparative experimental and clinical trials that have been conducted on these 2 agents. We believe that the available body of evidence indicates that atorvastatin may have several advantages over rosuvastatin, despite the latter's greater potency, suggesting that atorvastatin should be the potent statin of choice, especially in treating patients with renal impairment or heart failure with concomitant coronary artery disease. The recent availability of atorvastatin as a generic option gives this drug another practical and compelling advantage over rosuvastatin.
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Statins for primary prevention of venous thromboembolism.
Li, L, Sun, T, Zhang, P, Tian, J, Yang, K
The Cochrane database of systematic reviews. 2011;(12):CD008203
Abstract
BACKGROUND Venous thromboembolism (VTE) is common in clinical practice. The efficacy of statins in the primary prevention of VTE remains unproven. OBJECTIVES To assess the efficacy of statins in the primary prevention of VTE. SEARCH METHODS The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialised Register (last searched April 2011) and CENTRAL (2011, Issue 2). The authors searched MEDLINE (January 1966 to March 2011); EMBASE (1974 to March 2011); ISI Web of Knowledge (2001 to March 2011); the Chinese Biomedical Literature Database (1978 to March 2011) and other resources (including clinical trials registers, reference lists and presentations at various conferences. SELECTION CRITERIA Randomised controlled trials (RCTs) that assessed statins were considered. The outcomes we evaluated were the rates of VTE, cardiovascular and cerebrovascular events, death and adverse events. Two authors independently selected RCTs against inclusion criteria. Disagreements were resolved by discussion with a third author. DATA COLLECTION AND ANALYSIS Data extraction was independently carried out by two authors. Disagreements were resolved by discussion with a third author. Two authors independently assessed the risk of bias according to a standard quality checklist provided by the PVD Group. MAIN RESULTS We included one RCT (17 citations) with 17,802 participants that assessed rosuvastatin for preventing VTE. Our analysis showed that rosuvastatin reduced the incidence of VTE (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.37 to 0.86) and deep vein thrombosis (DVT) (OR 0.45, 95% CI 0.25 to 0.79), the risk of any (fatal and non-fatal) myocardial infarction (MI) (OR 0.45, 95% CI 0.30 to 0.69), any (fatal and non-fatal) stroke (OR 0.51, 95% CI 0.34 to 0.78), but did not reduce the incidence of pulmonary embolism (PE) (OR 0.77, 95% CI 0.41 to 1.46) and death after VTE (OR 0.50, 95% CI 0.20 to 1.24). Rosuvastatin did not reduce the incidence of any serious adverse event (OR 0.95, 95% CI 0.90 to 1.06). AUTHORS' CONCLUSIONS Available evidence showed that rosuvastatin was associated with a reduced incidence of VTE, but the evidence was limited to a single RCT. Randomised controlled trials of statins (including rosuvastatin) are needed to evaluate the efficacy of statins in the prevention of VTE.
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The role of C-reactive protein as a risk predictor of coronary atherosclerosis: implications from the JUPITER trial.
Abd, TT, Eapen, DJ, Bajpai, A, Goyal, A, Dollar, A, Sperling, L
Current atherosclerosis reports. 2011;(2):154-61
Abstract
Much controversy surrounds the use of high-sensitivity C-reactive protein (hs-CRP) as a marker of cardiovascular (CV) risk. Although data regarding the association of hs-CRP with CV disease is extensive and consistent, its role in clinical practice remains unclear. The American Heart Association (AHA) recently published a scientific statement regarding criteria for evaluation of novel markers of CV risk. This article provides a comprehensive review of data regarding hs-CRP as a risk marker for CV disease in the context of these AHA criteria. The impact of the JUPITER trial on the utility of hs-CRP as a risk marker is emphasized. The review concludes with an evidence-based statement regarding the current role of hs-CRP in CV risk prediction.
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The ABCG2 transporter and its relations with the pharmacokinetics, drug interaction and lipid-lowering effects of statins.
Hu, M, To, KK, Mak, VW, Tomlinson, B
Expert opinion on drug metabolism & toxicology. 2011;(1):49-62
Abstract
IMPORTANCE OF THE FIELD The ABCG2 efflux transporter is expressed in multiple tissues and plays an important role in the disposition of many statins. The functional 421C>A polymorphism in ABCG2 that reduces transporter activity has been found to be associated with increased systemic exposures to certain statins. AREAS COVERED IN THIS REVIEW We review and evaluate the associations of the ABCG2 polymorphism on the pharmacokinetics and clinical efficacy of statins. WHAT THE READER WILL GAIN This article gives a detailed overview of the ABCG2 transporter and extensively reviews its relations with the pharmacokinetics and lipid-lowering effects of statins. This review also discusses the potential role of the ABCG2 polymorphism in the clinical outcomes in statin-treated patients and statin-drug interactions. TAKE HOME MESSAGE The impact of the ABCG2 421C>A polymorphism on the disposition of the statins varies between different drugs and the effect on systemic exposure was greater in the case of rosuvastatin than other statins. This genetic variant was associated with greater low-density lipoprotein cholesterol response to rosuvastatin in Chinese and caucasian patients. The effect of the ABCG2 421C>A polymorphism on the lipid response to other substrate statins and clinical outcomes need to be evaluated in future studies.
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Clinical utility of rosuvastatin and other statins for cardiovascular risk reduction among the elderly.
Long, SB, Blaha, MJ, Blumenthal, RS, Michos, ED
Clinical interventions in aging. 2011;:27-35
Abstract
Age is one of the strongest predictors of cardiovascular disease (CVD) risk. Treatment with statins can significantly reduce CVD events and mortality in both primary and secondary prevention. Yet despite the high CVD risk among the elderly, there is underutilization of statins in this population (ie, the treatment-risk paradox). Few studies have investigated the use of statins in the elderly, particularly for primary prevention and, as a result, guidelines for treating the elderly are limited. This is likely due to: uncertainties of risk assessment in older individuals where the predictive value of individual risk factors is decreased; the need to balance the benefits of primary prevention with the risks of polypharmacy, health care costs, and adverse medication effects in a population with decreased life expectancy; the complexity of treating patients with many other comorbidities; and increasingly difficult social and economic concerns. As life expectancy increases and the total elderly population grows, these issues become increasingly important. JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) is the largest primary prevention statin trial to date and enrolled a substantial number of elderly adults. Among the 5695 JUPITER participants ≥ 70 years of age, the absolute CVD risk reduction associated with rosuvastatin was actually greater than for younger participants. The implications of this JUPITER subanalysis and the broader role of statins among older adults is the subject of this review.
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Meta-analysis of comparative efficacy of increasing dose of Atorvastatin versus Rosuvastatin versus Simvastatin on lowering levels of atherogenic lipids (from VOYAGER).
Nicholls, SJ, Brandrup-Wognsen, G, Palmer, M, Barter, PJ
The American journal of cardiology. 2010;(1):69-76
Abstract
Statins are the most commonly prescribed agents for lowering levels of low-density lipoprotein (LDL) cholesterol. Although dose-dependent reductions in levels of atherogenic lipids are observed with all statins, the impact of increasing dose has not been fully elucidated. An individual patient data pooled analysis was performed of 32,258 patients in studies comparing the efficacy of rosuvastatin with that of atorvastatin or simvastatin. The impact of increasing dose on lowering LDL cholesterol, triglycerides, non-high-density lipoprotein (HDL) cholesterol, and apolipoprotein B was investigated. Doubling the dose of each statin was accompanied by a 4% to 7% greater degree of lowering of all atherogenic lipids. A stronger correlation was observed between changes in LDL cholesterol and non-HDL cholesterol (r = 0.92, p <0.001) or apolipoprotein B (r = 0.76, p <0.001) than triglycerides (r = 0.14, p <0.001). On multivariate analysis, baseline lipid level (p <0.0001) and increasing statin dose (p <0.0001) were strong predictors of achieving treatment goals in high-risk patients. Increasing age was a strong independent predictor of achieving goal for all atherogenic lipids (p <0.0001). Achieving LDL cholesterol goals was also more likely in women (p <0.0001), patients with diabetes (p <0.0001), and patients without atherosclerotic disease (p = 0.0002). In contrast, normal triglyceride levels were more often observed in men (p <0.0001) and patients without diabetes mellitus (p = 0.03). In conclusion, doubling statin dose was associated with greater lowering of LDL cholesterol by 4% to 6% and non-HDL cholesterol by 3% to 6%. Greater lipid goal achievement with increasing dose supports the use of high-dose statin therapy for more effective cardiovascular prevention.