瑞舒伐他汀与阿托伐他汀治疗老年高脂血症患者的有效性与安全性的比较研究

目的比较及研究瑞舒伐他汀与阿托伐他汀治疗老年高脂血症患者的有效性及安全性。方法将200例老年高脂血症患者随机分成A、B两组,每组各100例。A组:给予瑞舒伐他汀,10 mg/d;B组:给予阿托伐他汀,10mg/d。分别在治疗前以及治疗8周后检测患者血清总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、肌酸磷酸激酶(CK)、丙氨酸氨基转移酶(ALT)的水平。结果两组均能显著降低TC、LDL-C、TG水平,升高HDL-C水平(P0.05),A组比C组作用更强(P0.05),且两组安全性均好。结论瑞舒伐他汀与阿托伐他汀对老年高脂血症患者均具有良好疗效,均能显著的降低血脂水平,瑞舒伐他汀作为临床最新上市的他汀类药物,比阿托伐他汀疗效更佳,两者的安全性无显著差异,均较为安全。     

瑞舒伐他汀与阿托伐他汀对冠心病患者血清脂肪因子Vaspin的影响

目的:探讨瑞舒伐他汀与阿托伐他汀对冠心病患者血清内脏脂肪组织来源的丝氨酸蛋白酶抑制剂(Vaspin)的影响。方法:连续选取70例冠心病患者,随机分为瑞舒伐他汀组(10 mg/d)与阿托伐他汀组(20 mg/d),采用酶联免疫吸附法(ELISA)测定所有研究对象血清Vaspin水平,观察药物治疗前后冠心病患者血清Vaspin水平变化。结果:药物治疗8周后,两组患者血胆固醇、低密度脂蛋白、三酰甘油和高敏C反应蛋白水平均明显降低(P<0.05)。瑞舒伐他汀组较阿托伐他汀组血清Vaspin水平明显增高(P<0.01)。相关性分析表明,两组患者的血清Vaspin水平与血TC、TG、LDL-C、HDL-C和hs-CRP无相关性(P>0.05)。结论:与阿托伐他汀相比,瑞舒伐他汀更能有效增高血清Vaspin水平。     

瑞舒伐他汀对高胆固醇血症患者炎症细胞因子的影响

目的:探讨瑞舒伐他汀对高胆固醇血症患者炎症细胞因子的影响,证实瑞舒伐他汀的抗炎作用.方法:入选110例高胆固醇血症患者,随机分成瑞舒伐他汀治疗组36例、阿托伐他汀治疗组38例和饮食治疗组36例;我院体检中心入选30例健康者作为正常对照组.给予瑞舒伐他汀、阿托伐他汀治疗及饮食治疗治疗8周,治疗前及治疗后分别检测白介素-6(IL-6)、白介素-10(IL-10)及肿瘤坏死因子α(TNF-α)等.结果:与治疗前相比,瑞舒伐他汀治疗组和阿托伐他汀治疗组治疗8周后IL-6及TNF-α显著降低(均P<0.05),而IL-10显著升高(均P<0.05).饮食治疗组治疗8周后IL-6、IL-10及TNF-α差异无显著性(均P>0.05).结论:瑞舒伐他汀能够显著升高血清IL-10水平,而显著降低血清IL-6和TNF-α水平,可能是其抗动脉粥样硬化及改善心血管疾病预后的重要机制之一.     

超声造影评价瑞舒伐他汀与阿托伐他汀对颈动脉斑块新生血管作用的比较

目的：使用超声造影比较瑞舒伐他汀与阿托伐他汀对颈动脉软斑块新生血管的治疗效果。方法：对颈动脉软斑块患者,分别服用瑞舒伐他汀10mg/d或阿托伐他汀20mg/d,治疗6个月,利用血脂检查、常规超声及超声造影进行治疗前后相关指标的评估。结果：入选斑块数共80例,瑞舒伐他汀组与阿托伐他汀组血清总胆固醇（TC）、甘油三酯（TG）和低密度脂蛋白胆固醇（LDL-C）水平均显著低于治疗前（P<0.05）,瑞舒伐他汀组TC和LDL-C水平显著低于阿托伐他汀组（P<0.05）,但两组间TG水平无显著差别（P>0.05）。瑞舒伐他汀组与阿托伐他汀组斑块积分、增强强度（EI）及时间-强度曲线下面积（AUC）均显著低于治疗前（P<0.05）,瑞舒伐他汀组斑块积分、EI及AUC均显著低于阿托伐他汀组（P<0.05）。结论：瑞舒伐他汀及阿托伐他汀有确切降脂作用,均可有效减少颈动脉软斑块内的新生血管,且瑞舒伐他汀作用强于阿托伐他汀。     

阿托伐他汀和瑞舒伐他汀对2型糖尿病血脂和高敏C反应蛋白作用效果的比较

目的比较阿托伐他汀和瑞舒伐他汀对2型糖尿病血脂和高敏C反应蛋白作用效果的差异。方法随机入选年龄和性别匹配的2型糖尿病合并血脂异常患者64例,分为2组,每组32例。根据NCEP-ATPⅢ指南,分别服用阿托伐他汀(40～80mg)或者瑞舒伐他汀(10～40mg)3个月。比较两组间血脂和高敏C反应蛋白的水平差异。结果在2型糖尿病患者中,阿托伐他汀和瑞舒伐他汀都显著降低总胆固醇、低密度脂蛋白胆固醇、甘油三酯和高敏C反应蛋白水平(P<0.05),升高高密度脂蛋白胆固醇水平。此外,两组在降低甘油三酯和高敏C反应蛋白水平、升高高密度脂蛋白胆固醇水平上无差异。但是,瑞舒伐他汀更显著地降低了总胆固醇和低密度脂蛋白胆固醇水平。结论本研究显示瑞舒伐他汀在2型糖尿病患者中在降低总胆固醇和低密度脂蛋白胆固醇水平方面更有效。     

不同剂量瑞舒伐他汀治疗血脂异常的疗效

目的研究分析采用不同剂量瑞舒伐他汀治疗血脂异常的临床治疗效果。方法选择2010年10月至2013年10月血脂异常患者140例,随机分为观察组和对照组,每组70例。观察组采用瑞舒伐他汀10 mg/d,对照组采取瑞舒伐他汀5 mg/d。对比两组患者连续治疗4、8周后的调脂、低密度脂蛋白胆固醇（LDL-C）达标率以及不良反应的发生率等。结果两组治疗8周后血清总胆固醇、高密度脂蛋白胆固醇、三酰甘油、载脂蛋白A、载脂蛋白B较治疗前均显著改善,差异有统计学意义（P〈0.05）。观察组治疗8周后LDL-C水平及LDL-C达标情况明显优于对照组（P〈0.05）。结论对于治疗血脂异常的心血管病患者,采用瑞舒伐他汀10 mg/d能够达到满意效果,有效降低LDL-C水平,临床应用价值更显著。     

瑞舒伐他汀与阿托伐他汀治疗缺血性脑卒中的疗效

目的比较分析瑞舒伐他汀与阿托伐他汀治疗缺血性脑卒中(CAT)患者的疗效。方法将120例CAT患者按随机数字表法分为观察组与对照组,每组60例。在常规治疗(改善患者血液循环与血小板凝集)的基础上,观察组患者给予瑞舒伐他汀5mg,口服,2次·d-1;对照组给予阿托伐他汀10mg,口服,2次·d-1。2组患者均连续用药8周为1个疗程。观察2组患者治疗前、治疗1个疗程后血脂参数[低密度脂蛋白(LDL-C)、高密度脂蛋白(HDL-C)、胆固醇(TC)、三酰甘油(TG)]、内皮舒张功能(FMD)及左室射血分数(LVEF)的变化。结果治疗前2组TG、TC、LDL-C、HDL-C、LVEF及FMD比较差异均无统计学意义(均P>0.05)。治疗8周后观察组的TG、TC、LDL-C、LVEF显著低于对照组,HDL-C、FMD显著高于对照组(均P<0.05)。结论瑞舒伐他汀治疗CAT患者较阿托伐他汀有较大的优势,能显著地改善患者的心功能指标与各种症状。更多还原     

国产阿托伐他汀治疗高危冠心病患者的疗效和安全性

目的:观察国产阿托伐他汀强化降脂治疗对冠心病高危患者的疗效和其安全性。方法:选择临床确诊为冠心病高危患者104例,随机分为两组:阿托伐他汀10mg.d-1组(n=50);阿托伐他汀40mg.d-1组(n=54)。分别于用药前、用药1个月、3个月、6个月时测定血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C),高密度脂蛋白胆固醇(HDL-C)、三酰甘油(TG)、血糖(GLU)、肝肾功能和肌酸激酶(CK),共治疗6个月。结果:(1)治疗6个月后,与治疗前相比,阿托伐他汀10mg.d-1组LDL-C、TC、TG水平分别降低38.04%、29.37%、20.74%,HDL水平升高了5.98%。40mg.d-1组LDL-C、TC、TG水平分别降低49.14%、37.69%、26.98%,HDL水平升高3.48%。10mg.d-1组LDL-C的达标率为54.00%,40mg.d-1组LDL-C的达标率为79.24%。两组间LDL-C的达标率有显著差异(P<0.01)。(2)两组间治疗前后肝肾功能和肌酸激酶等未见明显差异。结论:口服阿托伐他汀40mg.d-1较10mg.d-1治疗能更有效的降低LDL-C、TC和TG水平,使LDL-C水平达标率高,且两者的安全性一致。     

瑞舒伐他汀与不同剂量阿托伐他汀对急性冠状动脉综合征患者炎症因子的影响

目的 探讨10 mg、20 mg的阿托伐他汀和10 mg瑞舒伐他汀对急性冠状动脉综合征(ACS)患者炎症因子的影响.方法 66例ACS患者随机分为3组:10 mg阿托伐他汀治疗组、20 mg阿托伐他汀治疗组和10 mg瑞舒伐他汀治疗组,各22例.分别检测治疗前和治疗2周后血清基质金属蛋白酶-9(MMP-9)和纤溶酶原激活剂抑制因子-1(PAI-1)的水平以及与血脂变化的相关性.并选同期冠状动脉造影正常者19例作为正常对照组.结果 ACS患者血脂(除TG外)、血清中MMP-9和PAI-1的浓度与正常对照组比较差异均有统计学意义(P＜0.05或P＜0.01),经阿托伐他汀和瑞舒伐他汀治疗后3组各检测指标除甘油TG外与治疗前比较差异均有统计学意义(P均＜0.01);以阿托伐他汀20 mg和瑞舒伐他汀10 mg治疗组变化幅度最大(P＜0.05或P＜0.01).阿托伐他汀和瑞舒伐他汀降低血清MMP-9和PAI-1的浓度与血脂变化无相关性(P均＞0.05).结论 瑞舒伐他汀10 mg具有独立于降脂作用之外的抗炎效应,较阿托伐他汀10 mg更能显著降低ACS患者血清MMP-9和PAI-1的水平,效果等同于阿托伐他汀20 mg.     

瑞舒伐他汀与阿托伐他汀治疗冠心病的临床对比

选取我院自2011年1月~2012年1月收治的92例冠心病患者,随机将其分为观察组和对照组各46例,给予观察组患者瑞舒伐他汀治疗,给予对照组患者阿托伐他汀治疗,对两组患者治疗前后低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)、三酰甘油(TG)的变化情况及不良反应情况进行对比。两组患者治疗前LDL-C、TC、TG指标对比均无显著差异,(P0.05),治疗后两组患者的各项治疗均有所改善,但观察组患者的改善情况明显优于对照组(P0.05),两组患者均未出现严重不良反应现象。给予冠心病患者瑞舒伐他汀与阿托伐他汀均能起到良好的治疗效果,但两者相比瑞舒伐他汀的效果更为显著,值得推广和应用。     

Achieving low-density lipoprotein cholesterol goals in high-risk patients in managed care: comparison of rosuvastatin, atorvastatin, and simvastatin in the SOLAR trial

OBJECTIVE: To evaluate attainment of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III low-density lipoprotein cholesterol (LDL-C) goal of less than 100 mg/dL with statin treatments in managed care patients at high risk for coronary heart disease. PATIENTS AND METHODS: In a randomized, open-label, multicenter trial (SOLAR [Satisfying Optimal LDL-C ATP III goals with Rosuvastatin]) performed at 145 US clinical centers from June 5, 2002 to July 12, 2004, high-risk men and women in a managed care population received typical starting doses of rosuvastatin (10 mg/d), atorvastatin (10 mg/d), or simvastatin (20 mg/d) for 6 weeks. Those who did not meet the LDL-C target of less than 100 mg/dL at 6 weeks had their dose titrated (doubled), and all patients were followed up for another 6 weeks. RESULTS: A total of 1632 patients were randomized to 1 of the 3 treatment regimens. After 6 weeks, 65% of patients taking rosuvastatin reached the LDL-C target of less than 100 mg/dL vs 41% with atorvastatin and 39% with simvastatin (P<.001 vs rosuvastatin for both). After 12 weeks, 76% of patients taking rosuvastatin reached the LDL-C target of less than 100 mg/dL vs 58% with atorvastatin and 53% with simvastatin (P<.001 vs rosuvastatin for both). Reductions in the LDL-C level, total cholesterol level, non-high-density lipoprotein cholesterol (non-HDL-C) level, and non-HDL-C/HDL-C ratio were significantly greater with rosuvastatin at both 6 and 12 weeks compared with the other statins. Adverse events were similar in type and frequency in all treatment groups, and only 3% of all patients discontinued treatment because of adverse events. No myopathy was observed, no clinically important impact on renal function was attributed to study medications, and clinically important increases in serum transaminases were rare. CONCLUSION: In a managed care population, 10 mg of rosuvastatin treatment resulted in more patients reaching the NCEP ATP III LDL-C goal compared with 10 mg of atorvastatin and 20 mg of simvastatin, potentially reducing the need for titration visits.     

Twelve-week, multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study

BACKGROUND: Guidelines for the prevention of coronary heart disease (CHD) advocate reductions in low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) levels as the primary goals. However, approximately 50% to 60% of patients fail to reach recommended cholesterol goals. OBJECTIVES: The primary objective of this Direct Statin Comparison of LDL-C Values: An Evaluation of Rosuvastatin Therapy Compared with Atorvastatin (DISCOVERY) trial was to compare the efficacy of the 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors rosuvastatin calcium and atorvastatin calcium in achieving the 1998 Second Joint Task Force (JTF) of European and Other Societies on Coronary Prevention target for LDL-C. Secondary objectives included comparing the efficacy of rosuvastatin and atorvastatin in achieving the 1998 JTF-recommended goal for TC and modifying other lipid levels, and to compare the tolerability of the 2 statins. METHODS: This 12-week, randomized, open-label, 2-arm, parallel-group trial was conducted at 210 centers in Finland, Iceland, and Ireland. Patients aged > or =18 years with a high risk for CHD and primary hypercholesterolemia (LDL-C >3.5 mmol/L [>135 mg/dL]) were randomized (2:1) to receive rosuvastatin 10 mg or atorvastatin 10 mg PO OD for 12 weeks. Before randomization, statin-naive patients underwent 6 weeks of dietary counseling, whereas patients receiving treatment with a starting dose of another lipid-lowering therapy but with an LDL-C level >3.1 mmol/L (>120 mg/dL) were switched to study drug immediately after they were determined eligible for the study Patients were assessed for fasting lipid levels at weeks 0 and 12, and the proportions of patients attaining 1998 and 2003 JTF lipid goals (1998: LDL-C, <3.0 mmol/L [<116 mg/dL]; TC, <5.0 mmol/L [<193 mg/dL]; 2003: LDL-C, <2.5 mmol/L [<97 mg/dL]; TC, <4.5 mmol/L [<174 mg/dL]) were calculated. Tolerability was monitored for the 12-week study and for an additional 36-week optional extension period. RESULTS: One thousand twenty-four patients were randomized to treatment (568 men, 456 women; mean age, 60.7 years). Patient demographic characteristics were similar between the 2 treatment groups. The efficacy analysis consisted of 911 patients (504 men, 407 women; mean age, 60.7 years; mean body weight, 82.4 kg); 627 received rosuvastatin and 284 received atorvastatin. Compared with atorvastatin, rosuvastatin was associated with significantly greater reductions in LDL-C and TC (both, P < 0.05), and with a significantly greater increase in high-density lipoprotein cholesterol level (P < (105). A greater proportion of patients in the rosuvastatin group compared with the atorvastatin group reached the 1998 goals for LDL-C (83.4% vs 683%; P < 0.001) and TC (76.4% vs 59.5%; P < 0.001). Also, compared with the atorvastatin group, greater proportions of patients in the rosuvastatin group achieved the 2003 JTF goals for LDL-C and TC (both, P < 0.001). Both agents were well tolerated: serious drug-related events were observed in < or =3.0% of patients in each group, and no clinically significant differences were found between the 2 treatment groups. CONCLUSIONS: In this study of selected patients at high risk for CHD and with primary hypercholesterolemia, rosuvastatin 10 mg/d for 12 weeks was associated with significantly greater reductions in LDL-C and TC levels compared with atorvastatin 10 mg/d. Furthermore, significantly more patients receiving rosuvastatin achieved the 1998 and 2003 JTF-recommended lipid targets compared with those receiving atorvastatin. Both agents were well tolerated.     

Effects of rosuvastatin versus atorvastatin on rho-associated coiled-coil containing protein kinase activity and endothelial function in patients with atherosclerosis

This randomized, double-blind, parallel-design study compared the short-term effects of rosuvastatin and atorvastatin on serum lipids and markers of inflammation and endothelial function in patients with stable atherosclerosis. Patients received either 10 mg/day rosuvastatin (n = 18) or 20 mg/day atorvastatin (n = 18), orally, for 4 weeks. Serum lipids, high-sensitivity Creactive protein (hsCRP), Rho-associated coiled-coil containing protein kinase (ROCK) activity and flow-mediated dilation (FMD) of the brachial artery were assessed before and after therapy. Both statins produced significant reductions in total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglyceride and hsCRP levels, and significant increases in FMD. Both statins significantly reduced ROCK activity and inhibition was significantly greater with rosuvastatin. There was no correlation between ROCK activity and LDL-C level in either group. There was a significant correlation between ROCK activity and FMD for both statins, but no correlations between FMD and LDL-C or hsCRP levels. Short-term treatment with either rosuvastatin or atorvastatin inhibits ROCK activity independent of cholesterol reduction, and improves endothelium dysfunction in patients with atherosclerosis.     

Rosuvastatin versus atorvastatin in achieving lipid goals in patients at high risk for cardiovascular disease in clinical practice: A randomized, open-label, parallel-group, multicenter study (DISCOVERY Alpha study)

Background:

The majority of clinical trials investigating the clinical benefits of lipid-lowering therapies (LLTs) have focused on North American or western and nothern European populations. Therefore, it is timely to confirm the efficacy of these agents in other patient populations in routine clinical practice.

Objective:

The aim of the Direct Statin COmparison of low-density lipoprotein cholesterol (LDL-C) Values: an Evaluation of Rosuvastatin therapY (DISCOVERY) Alpha study was to compare the effects of rosuvastatin 10 mg with those of atorvastatin 10 mg in achieving LDL-C goals in the Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice guidelines.

Methods:

This randomized, open-label, parallel-group study was conducted at 93 centers in eastern Europe (Estonia, Latvia, Romania, Russia, Slovenia), Central and South America (Chile, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama), and the Middle East (Israel, Kuwait, Saudi Arabia, United Arab Emirates). Male and female patients aged ≥18 years with primary hypercholesterolemia (LDL-C level, >135 mg/dL if LLT-naive or ≥120 mg/dL if switching statins; triglyceride [TG] level, <400 mg/dL) and a 10-year coronary heart disease (CHD) risk >20% or a history of CHD or other established atherosclerotic disease were eligible for inclusion in the study. Patients were randomly assigned to receive rosuvastatin 10-mg or atorvastatin 10-mg tablets QD for 12 weeks. No formal statistical analyses or comparisons were performed on lipid changes between switched and LLT-naive patients because of the different lipid inclusion criteria for these patients. The primary end point was the proportion of patients achieving 1998 European LDL-C goals after 12 weeks of treatment. A subanalysis was performed to assess the effects of statins in patients who had received previous statin treatment versus those who were LLT-naive. Tolerability was assessed using laboratory analysis and direct questioning of the patients.

Results:

A total of 1506 patients (52.1% women, 47.9% men; mean [SD] age, 58.2 [10.8] years) participated in the study (rosuvastatin, 1002 patients; atorvastatin, 504 patients; previous LLT, 567 patients). A significantly higher proportion of patients achieved 1998 European LDL-C goals after 12 weeks with rosuvastatin 10 mg than with atorvastatin 10 mg (72.5% vs 56.6%; P < 0.001). Similarly, more patients achieved the 2003 European LDL-C goals with rosuvastatin 10 mg compared with atorvastatin 10 mg (57.5% vs 39.2%). Rosuvastatin 10 mg was associated with a significantly greater change in LDL-C levels compared with atorvastatin 10 mg, in patients who were LLT-naive (LDL-C: −44.7% vs −33.9%; P < 0.001) and in patients who had received previous LLT (LDL-C: −32.0% vs −26.5%; P = 0.006). TG levels were also decreased with rosuvastatin 10 mg and atorvastatin 10 mg, although there was no significant difference between treatments. Similarly, there was no significant difference in the increase in high-density lipoprotein cholesterol levels between treatments. The most common adverse events overall were headache 16/1497 (1.1%), myalgia 10/1497 (0.7%), and nausea 10/1497 (0.7%).

Conclusions:

In this study in patients with primary hypercholesterolemia in clinical practice, greater reductions in LDL-C levels were achieved with a starting dose (10 mg) of rosuvastatin compared with atorvastatin 10 mg, with more patients achieving European LDL-C goals. Both treatments were well tolerated     

Cost-effectiveness analysis of rosuvastatin versus atorvastatin, simvastatin, and pravastatin from a Canadian health system perspective

OBJECTIVE: The primary objective of this study was to assess the cost-effectiveness of the most commonly prescribed doses of rosuvastatin, atorvastatin, simvastatin, and pravastatin for managing various lipid parameters in patients with hypercholesterolemia over a 1-year time horizon from a Canadian health care perspective. METHODS: Incremental cost-effectiveness ratios (ICERs) were estimated for branded rosuvastatin compared with branded atorvastatin, generic simvastatin, and generic pravastatin in patients with hypercholesterolemia in terms of percent reduction in low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C) ratio, as well as in TC, HDL-C, triglycerides (TG), apolipoprotein (Apo) B, the ApoB/ApoA-I ratio, and attainment of the Canadian LDL-C goal. The pharmacoeconomic model was constructed for a 1-year time horizon using efficacy data from a randomized, open-label trial including 2268 adults and the wholesale acquisition costs of branded rosuvastatin and atorvastatin and generic simvastatin and pravastatin in British Columbia. RESULTS: The most commonly prescribed doses of each of the 4 statins in British Columbia were as follows: rosuvastatin 10 mg (75.8% of all rosuvastatin doses); atorvastatin 10 and 20 mg (46.4% and 35.3%, respectively, of all atorvastatin doses); simvastatin 20 and 40 mg (42.5% and 31.8%, respectively, of all simvastatin doses); and pravastatin 20 and 40 mg (55.0% and 34.1%, respectively, of all pravastatin doses). Rosuvastatin 10 mg was dominant (ie, was more effective at a lower cost) relative to atorvastatin 10 and 20 mg, simvastatin 20 and 40 mg, and pravastatin 40 mg in terms of reductions in LDL-C, TC/ HDL-C ratio, TC, ApoB, and ApoB/ApoA-I ratio, increases in HDL-C, and attainment of the LDL-C goal. Compared with pravastatin 20 mg, the ICER per percent reduction in LDL-C, TC/HDL-C ratio, TC, TG, ApoB, or ApoB/ApoA-I or increase in HDL-C ranged from $3.89 to $26.07; the value for 1 additional patient achieving the LDL-C goal was $419.75. When the statin doses were aggregated based on the Canadian statin-utilization pattern, rosuvastatin was dominant relative to atorvastatin on all effectiveness measures evaluated. When rosuvastatin was compared with generic simvastatin and pravastatin, the annual costs for 1 additional patient achieving the LDL-C goal were $144.51 and $373.91, respectively. Based on the sensitivity analysis, rosuvastatin was associated with the highest probability of cost-effectiveness compared with the other statins over a broad range of monetary values per unit of clinical effect. CONCLUSION: When percent changes in lipid parameters and rates of LDL-C goal attainment were considered in patients with hypercholesterolemia in British Columbia, rosuvastatin 10 mg was more cost-effective than the most frequently used doses of atorvastatin (10 and 20 mg), generic simvastatin (20 and 40 mg), and generic pravastatin (20 and 40 mg).     

Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia—Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia

ObjectiveThe purpose of this study was to compare the efficacy and tolerability of combination therapy of ezetimibe and atorvastatin in patients with high LDL cholesterol that had not reached the lipid management target value with 10 mg atorvastatin monotherapy, against increasing the dose to 20 mg atorvastatin or switching to 2.5 mg rosuvastatin.Design, setting, and participantsThis was an open-label, randomized, multicenter, 3-parallel-group comparison trial at 23 community hospitals and clinics in Japan (enrollment period March 2009 to May 2010) in 125 patients with high LDL cholesterol.InterventionsA total of 125 Japanese patients with high LDL cholesterol level were randomized to 1 of the following 3 treatment groups: the ezetimibe (10 mg/d) and atorvastatin (10 mg/d) group, the atorvastatin (20 mg/d) group, or the rosuvastatin (2.5 mg/d) group for 12 weeks after treatment with 10 mg atorvastatin alone for 4 weeks.Main outcome measurePercent change in LDL cholesterol level from baseline (4 weeks after treatment with 10 mg atorvastatin alone) until study completion.ResultsThe percent change in LDL cholesterol level from baseline until study completion was statistically greater for the combination of 10 mg ezetimibe + 10 mg atorvastatin compared with increasing atorvastatin to 20 mg (?25.8% vs ?15.1%; P < 0.0001). A similar result was observed for ezetimibe + atorvastatin compared with switching to 2.5 mgt rosuvastatin (?25.8% vs 0.8%; P < 0.0001). The proportion of patients who reached the target LDL cholesterol value with the combination of ezetimibe + atorvastatin was significantly higher than increasing atorvastatin and switching to rosuvastatin (78.7%, 41.3%, and 3.1%, respectively). Although 5 serious adverse experiences bearing no relation to the study medications were reported, there were no adverse reactions.ConclusionsThe combination of 10 mg ezetimibe +10 mg atorvastatin was more effective than increasing atorvastatin to 20 mg or switching to 2.5 mg rosuvastatin in patients with hypercholesterolemia whose LDL cholesterol levels had not reached the recommended target value with 10 mg atorvastatin monotherapy for 4 weeks. Ezetimibe coadministration with atorvastatin was well tolerated. ClinicalTrials.gov identifier: NCT00871351.     

Efficacy and safety of rosuvastatin alone and in combination with cholestyramine in patients with severe hypercholesterolemia: a randomized, open-label, multicenter trial

BACKGROUND: Patients with severe hypercholesterolemia may need greater cholesterol reductions than can be achieved with statin therapy alone. OBJECTIVE: The primary objective of this trial was to compare the efficacy of a combination of rosuvastatin plus cholestyramine with that of rosuvastatin alone for reducing low-density lipoprotein cholesterol (LDL-C) levels after 6 weeks of treatment. METHODS: In this open-label, multicenter, randomized, parallel-group, comparator trial, adult patients with severe hypercholesterolemia (LDL-C level, 190-400 mg/dL) received rosuvastatin 40 mg/d for 6 weeks after a 6-week dietary lead-in period and were then randomized to 6 weeks of treatment with rosuvastatin 80 mg/d alone or rosuvastatin 80 mg/d plus cholestyramine 16 g/d (8 g BID with meals). RESULTS: Of 153 eligible patients, 147 (83 men, 64 women; mean [SD] age, 54.5 [13.7] years; mean [SD] bodyweight, 81.3 [14.4] kg) received randomized treatment, and 144 had post baseline measurements and were included in the analysis. The mean (SD) reduction in LDL-C was 522% (13.0%) after treatment with rosuvastatin 40 mg, and the least squares mean (SE) reductions in LDL-C were 56.4% (1.8%) and 60.5% (1.8%) after treatment with rosuvastatin 80 mg alone (n = 69) and rosuvastatin 80 mg plus cholestyramine (n = 75), respectively. No significant differences between treatments were found for these or other lipid measurements. Incremental LDL-C reductions >30% were obtained in 29% (22/75) of patients receiving combination therapy and 4% (3/69) of patients receiving rosuvastatin alone. The combination therapy was less well tolerated, primarily due to gastrointestinal symptoms; otherwise, the treatments were generally well tolerated. CONCLUSION: In this group of patients with severe hypercholesterolemia, the combination of rosuvastatin 80 mg with cholestyramine 16 g/d did not provide a significantly greater efficacy benefit than rosuvastatin alone.     

Effects of rosuvastatin versus atorvastatin, simvastatin, and pravastatin on non-high-density lipoprotein cholesterol, apolipoproteins, and lipid ratios in patients with hypercholesterolemia: additional results from the STELLAR trial

BACKGROUND: Non-high-density lipoprotein cholesterol (HDL-C), apolipoprotein (apo) B, and lipid and apolipoprotein ratios that include both atherogenic and antiatherogenic lipid components have been found to be strong predictors of coronary heart disease risk. OBJECTIVE: The goal of this study was to examine prospectively the effects of rosuvastatin, atorvastatin, simvastatin, and pravastatin across dose ranges on non-HDL-C, apo B, apo A-I, and total cholesterol (TC):HDL-C, low-density lipoprotein cholesterol (LDL-C):HDL-C, non-HDL-C:HDL-C, and apo B:apo A-I ratios in patients with hypercholesterolemia (LDL-C > or =160 mg/dL and <250 mg/dL and triglycerides <400 mg/dL) in the Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin (STELLAR) trial. METHODS: In this randomized, Multicenter, parallel-group, open-label trial (4522IL/0065), patients > or =18 years of age received rosuvastatin 10, 20, 40, or 80 mg; atorvastatin 10, 20, 40, or 80 mg; simvastatin 10, 20, 40, or 80 mg; or pravastatin 10, 20, or 40 mg for 6 weeks. Pairwise comparisons were prospectively planned and performed between rosuvastatin 10, 20, and 40 mg and milligram-equivalent or higher doses of comparators. RESULTS: A total of 2268 patients were randomized to the rosuvastatin 10- to 40-mg, atorvastatin, simvastatin, and pravastatin groups. Fifty-one percent of patients were women, the mean (SD) age was 57 (12) years, and 19% had a documented history of atherosclerotic disease. Over 6 weeks, rosuvastatin significantly reduced non-HDL-C, apo B, and all lipid and apolipoprotein ratios assessed, compared with milligram-equivalent doses of atorvastatin and milligram-equivalent or higher doses of simvastatin and pravastatin (all, P < 0.002). Rosuvastatin reduced non-HDL-C by 42.0% to 50.9% compared with 34.4% to 48.1% with atorvastatin, 26.0% to 41.8% with simvastatin, and 18.6% to 27.4% with pravastatin. Rosuvastatin reduced apo B by 36.7% to 45.3% compared with 29.4% to 42.9% with atorvastatin, 22.2% to 34.7% with simvastatin, and 14.7% to 23.0% with pravastatin. The highest increase in apo A-I (8.8%) was observed in the rosuvastatin 20-mg group, and this increase was significantly greater than in the atorvastatin 40-mg and 80-mg groups (both, P < 0.002). CONCLUSION: Rosuvastatin 10 to 40 mg was more efficacious in improving the lipid profile of patients with hypercholesterolemia than milligram-equivalent doses of atorvastatin and milligram-equivalent or higher doses of simvastatin and pravastatin.     

Hemostatic effects of atorvastatin versus simvastatin

OBJECTIVE: To compare the effects of simvastatin and atorvastatin on hemostatic parameters. METHODS: Sixty-one patients with primary hypercholesterolemia without coronary heart disease were treated with atorvastatin 10-20 mg/d or simvastatin 10-20 mg/d. At baseline, 4, 12, and 24 weeks, lipid levels such as low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), very-low-density lipoprotein cholesterol (VLDL-C), triglycerides (TGs), and hemostatic parameters such as platelet counts, partial thromboplastin time (PTT) prothrombin time (PT), and fibrinogen levels were measured. RESULTS: At 12 weeks, the doses of the statins were increased to 20 mg/d in 10 of 35 (28.5%) patients treated with atorvastatin and 18 of 26 (69.2%) patients treated with simvastatin when the target level of LDL-C (130 mg/dL) was not reached. Mean doses were atorvastatin 12.8 mg/d and simvastatin 16.9 mg/d. After 24 weeks, 5 patients (14.3%) in the atorvastatin group and 4 patients (15.3%) in the simvastatin group had not reached the goal. In patients with diabetes, target level (LDL-C <100 mg/dL) was not reached in 35.7% of patients in the atorvastatin group and 44.4% of patients in the simvastatin group. Both simvastatin and atorvastatin were effective in lowering TC and LDL-C levels (p < 0.001). Atorvastatin lowered TGs significantly (p < 0.01). Neither atorvastatin nor simvastatin significantly reduced VLDL-C levels. HDL-C levels increased with atorvastatin, but there was no significant difference between the 2 groups. Platelet counts decreased with both statins nonsignificantly. Moreover, fibrinogen levels decreased with simvastatin and atorvastatin, but these reductions were significant only for simvastatin (p < 0.05). We detected prolongation of the PT with both drugs (p < 0.05); however, prolongation of the PTT was significant only with simvastatin (p < 0.001). Effectiveness of both statins on lipid and hemostatic parameters was dose related. Adverse effects were seen in 5 patients (14.2%) treated with atorvastatin and 3 patients (11.5%) treated with simvastatin. Elevations in serum transaminase levels >3 times the upper limit of normal and in creatine phosphokinase >5 times the upper limit of normal were not observed in any group. CONCLUSIONS: Atorvastatin was more effective than simvastatin on lipid parameters, although statistically insignificantly, while simvastatin produced more significant changes than atorvastatin on hemostatic parameters. The mean dose of simvastatin was greater than that of atorvastatin. Both statins had increased effects on lipid and hemostatic parameters when doses were increased. Atorvastatin and simvastatin were well tolerated. Different effects of statins on lipid levels and on coagulation parameters should be considered in patients with hypercholesterolemia and tendency to coagulation, especially in preventing thrombotic events. Further studies in larger trials are needed to confirm these observations.