Efficacy of a low dose-range of fluvastatin (XU 62-320) in the treatment of primary hypercholesterolaemia. A dose-response study in 431 patients. The French-Dutch Fluvastatin Study Group.

1. In this randomised, double-blind, placebo-controlled study, the efficacy of four dosages of fluvastatin (2.5, 5, 10 and 20 mg day-1) were assessed in 431 patients with primary hypercholesterolaemia recruited in 17 centres. 2. Following an 8-week dietary stabilisation phase and a 6-week placebo phase, the patients were randomised to receive placebo or fluvastatin 2.5, 5, 10 or 20 mg once daily at night for a period of 6 weeks. 3. Total cholesterol, beta-quant LDL-C, and the beta-quant LDL-C/HDL-C ratio were significantly reduced by all doses of fluvastatin, and HDL-C was significantly increased by the 10 mg and 20 mg doses. Fluvastatin 20 mg day-1 also significantly decreased TG and Lp(a):B levels. 4. Fluvastatin was well tolerated during the study, and relatively few biochemical or haematological abnormalities occurred. 5. Of the dosages tested, 20 mg fluvastatin day-1 is the optimal hypolipidaemic dose.     

氟伐他汀对原发性高血压患者血压和左心室肥厚的影响

目的探讨氟伐他汀对原发性高血压患者血压、脉压和左心室肥厚的影响。方法将80例原发性高血压患者随机分为对照组(40例,氨氯地平5mg/d)、氟伐他汀组(40例,氨氯地平5mg/d加氟伐他汀40mg/d),连续治疗3个月。在用药前后测定两组患者的血清总胆固醇(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)浓度及血压水平,计算脉压。采用超声心动图测舒张末期左心室内径(LVID)、室间隔厚度(IVST)、左心室后壁厚度(LPWT),计算左心室重量指数(LVMI)。结果治疗3个月后,氟伐他汀组患者血清TC、TG、LDL-C均显著降低,而HDL-C明显增高(P<0.05)。两组患者的收缩压、舒张压、脉压和LVMI也明显降低,且氟伐他汀组显著低于对照组(P<0.05)。结论氟伐他汀可显著降低原发性高血压患者血压、缩小脉压,使降压更平稳,且能逆转左心室肥厚。     

瑞舒伐他汀治疗不稳定型心绞痛的临床疗效研究

目的 对比瑞舒伐他汀及氟伐他汀在治疗不稳定型心绞痛（UAP）中的临床疗效.方法 将本院2009年3月～2012年3月收治的138例确诊为UAP的患者按照随机对照的原则分为A、B两组,每组各69例,全部患者均采取抗血小板治疗,并给予β受体阻滞剂、钙离子拮抗剂及硝酸酯类药物.在以上常规治疗措施进行的同时,A组患者另给予每晚40 mg氟伐他汀,B组患者另给予每晚10 mg瑞舒伐他汀,疗程为8周.对两组患者的临床疗效及高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）及C-反应蛋白（CRP）的改善情况进行比较.结果 全部患者经治疗,B组患者的有效率（94.2％）显著高于A组（69.6％）,差异具有统计学意义（P＜0.01）.全部患者治疗后HDL-C水平较治疗前明显提高,而LDL-C及CRP水平较治疗前明显降低,差异具有统计学意义（P＜0.05）.且治疗后B组患者的HDL-C水平上升及LDL-C及CRP下降程度与A组患者比较更加明显,差异具有统计学意义（P＜0.05）.结论 瑞舒伐他汀能在调脂及抗炎上充分发挥其作用,可明显改善患者的HDL-C、LDL-C及CRP水平,在UAP的治疗效果上优于氟伐他汀.     

氟伐他汀联合苯扎贝特治疗冠心病合并混合型高脂血症的临床观察

目的：观察氟伐他汀联合苯扎贝特治疗冠心病合并混合型高脂血症的调脂效果及安全性。方法：将我中心332例高脂血症患者随机分为4组,每组83例。A组口服氟伐他汀40mg·d^-1,B组口服苯扎贝特400mg·d^-1,C组口服氟伐他汀20mg·d^-1＋苯扎贝特400mg·d^-1,D组口服氟伐他汀40mg·d^-1＋苯扎贝特400mg·d^-1,4组疗程均为24周。观察患者血脂变化及不良反应等。结果：与治疗前比较,4组低密度脂蛋白胆固醇（LDL-C）均显著降低,高密度脂蛋白胆固醇（HDL-C）显著上升（P〈0．05）,且治疗后A、C、D组LDL-C显著优于B组（P〈0．001）,B、C、D组HDL-C显著优于A组（P〈0．001）。其中,D组各项指标治疗效果最佳。4组患者均具有较好的耐受性,均未见严重不良反应发生。结论：氟伐他汀40mg联合苯扎贝特400mg治疗混合型高脂血症疗效较好,能有效纠正各项临床指标,具有较好的安全性和耐受性。     

Time-dependent lipid response on fluvastatin therapy of patients with hypercholesterolemia sensitive to apoE phenotype

Sixty-seven male patients with hypercholesterolemia, divided into three groups according to apolipoprotein E phenotype (33 with apoE3/ 3 phenotype, E3 group; 23 with 2/2 or 2/3, E2+ group; 11 with 4/4 or 4/3, E4+ group), received daily 20-40 mg of fluvastatin for 12 weeks. The levels of triglyceride (TG), cholesterol (Chol), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) were measured after 0, 4, 8 and 12 weeks on fluvastatin and after 4 weeks washout period. Lipid percentage changes (delta) were not associated with apoE phenotype for any treatment time. Cholesterol decreased by 14% after 12 weeks and HDL-C increased by 14-16% after 12 weeks for three phenotype groups. deltaTG, deltaChol, deltaLDL-C were associated positively, while negatively for deltaHDL-C, with the corresponding basal lipid values for the three groups. The positive deltaTG values occurred at a low basal TG0 level and became negative at TG0 > 1.6-1.9 mM. For E3 and E4+ groups, only a single parameter contributed significantly into a variation of lipid percentage changes. For the E2+ group, TG0 and Chol0 contributed in a reciprocal manner into deltaTG12/0, both positively into deltaChol8/0; Chol0 and HDL-C0 both negatively contributed into deltaHDL-C12/0. HDL-C0 contributed reciprocally into LDL-C variability for E2+ and E4+ groups. Three effects seem to contribute differently into lipid response among patients with different apoE phenotype: the inhibition of hepatic and lipoprotein lipase activities, the competition between TG-rich and low-density lipoproteins for LDL-receptor and the accumulation of intermediate-density lipoproteins in patients bearing E2 isoform.     

氟伐他汀联合非诺贝特治疗混合性高脂血症的可行性探讨

目的观察氟伐他汀联合非诺贝特治疗混合性高脂血症的临床效果。方法选择2007年1月至2008年12月南通市老年康复医院心内科门诊混合性高脂血症患者180例,随机分为氟伐他汀组、非诺贝特组、联合用药组各60例;氟伐他汀组每晚口服40mg氟伐他汀、非诺贝特组每晚口服非诺贝特200mg、联合用药每日清晨口服非诺贝特200mg,晚口服氟伐他汀20mg,均用至12周。观察血脂参数变化、疗效评价、药物主要不良反应。结果三组TC、LDL-C、TG治疗前无差异(P>0.05),氟伐他汀组治疗后TC、LDL-C均有显著性下降(P<0.05),TG变化不明显(P>0.05);非诺贝特组治疗后TG有显著性下降(P<0.05),TC、LDL-C变化不明显(P>0.05);联合用药组TC、LDL-C、TG均有显著性下降(P<0.05)。联合用药组临床控制(显效、好转)83.3%(50/60)高于氟伐他汀组的68.3%(41/60)和非诺贝特组的65.0%。三组患者血清CK、肝肾功能等参数均无明显变化,未出现肌病症状,无1例退出或终止。结论氟伐他汀联合非诺贝特对混合性高脂血症具有良好的安全性与耐受性,具有临床应用可行性。     

LDL-C/HDL-C ratio in subjects with cardiovascular disease and a low HDL-C: results of the RADAR (Rosuvastatin and Atorvastatin in different Dosages And Reverse cholesterol transport) study

BACKGROUND: The ratio of low-density lipoprotein cholesterol and high-density lipoprotein cholesterol (LDL-C/HDL-C) is a reliable predictor of cardiovascular risk. Low HDL-C levels in patients with coronary artery disease are associated with a high risk for cardiovascular events. OBJECTIVES: This study compared the effects of rosuvastatin and atorvastatin on the LDL-C/HDL-C. METHODS: Patients aged 40-80 years with established cardiovascular disease and HDL-C < 1.0 mmol/L (< 40 mg/dL) entered as a 6-week dietary run-in period, before randomisation to open-label treatment with rosuvastatin 10 mg (n = 230) or atorvastatin 20 mg (n = 231) for 6 weeks. Doses were increased after 6 weeks to rosuvastatin 20 mg or atorvastatin 40 mg, and after 12 weeks to rosuvastatin 40 mg or atorvastatin 80 mg. Serum lipid parameters were measured at baseline and 6, 12 and 18 weeks. RESULTS: After 6 weeks of treatment, mean percentage change from baseline in LDL-C/HDL-C ratio was -47.0% in the rosuvastatin group and -41.9% in the atorvastatin group (p < 0.05 for between-group comparison). After 12 and 18 weeks of treatment, change from baseline was -53.0% and -57.3%, respectively, for rosucastatin, compared with -47.9% and -49.6%, respectively, for atorvastatin (p < 0.01 and p < 0.001, respectively, for between-group comparison). Rosuvastatin also reduced LDL-C, total cholesterol/HDL-C significantly more than atorvastatin at all three time points, and significantly improved total cholesterol/HDL-C and apolipoprotein B/A-I ratios. CONCLUSIONS: Rosuvastatin 10, 20 and 40 mg is significantly more effective than atorvastatin 20, 40 and 80 mg, respectively, in improving the LDL-C/HDL-C ratio in patients with cardiovascular disease and low HDL-C. Further studies are required to clarify the benefits of rosuvastatin for reduction of cardiovascular risk.     

氟伐他汀对2型糖尿病合并高血脂患者心脑保护作用分析

目的评价氟伐他汀对2型糖尿病合并高血脂患者的心脑保护作用。方法将287例2型糖尿病合并高血脂患者随机分为治疗组144例和对照组143例。治疗组服用氟伐他汀40～80mg/d,对照组不服用任何调节血脂的药物。观察2组治疗12周后三酰甘油（TG）、总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）及高密度脂蛋白胆固醇（HDL-C）水平。所有患者随访2年,记录随访期间患者发生的心脑血管事件。结果治疗组治疗第12周时上述血脂水平均改善,差异均有统计学意义（P〈0.05）;对照组治疗第12周时仅HDL-C水平与治疗前比较差异有统计学意义（P〈0.05）。且治疗第12周时,治疗组上述4个血脂水平均优于对照组,差异均有统计学意义（P〈0·05）。治疗组心脑血管事件发生率为4.2%低于对照组的10.5%,差异有统计学意义（P〈0.05）。结论氟伐他汀对2型糖尿病合并高血脂患者有一定的心脑保护作用,可降低心脑血管事件的发生率。     

瑞舒伐他汀与氟伐他汀治疗不稳定型心绞痛的对比研究

目的 对比瑞舒伐他汀与氟伐他汀治疗不稳定型心绞痛的疗效.方法 选取在我院内科住院的不稳定型心绞痛患者86例,随机分为两组,瑞舒伐他汀组在常规治疗(硝酸酯类、钙离子拮抗刺、抗血小板药物、抗凝血药物)基础上给予瑞舒伐他汀10 mg,氟伐他汀组在常规治疗基础上给予氟伐他汀40 mg,每晚1次,共用药8周,测定治疗前后病人LD...     

Comparison of the efficacy,safety and tolerability of original policosanol versus other mixtures of higher aliphatic primary alcohols in patients with type II hypercholesterolemia

This randomized, double-blind study was undertaken to compare the efficacy and tolerability of policosanol and Octa-60 in patients with type II hypercholesterolemia. After 4 weeks on a diet, 110 patients were randomized to policosanol or Octa-60 5 mg tablets once a day for 5 weeks. The dose was then doubled to 10 mg/day for the next 5 weeks. Policosanol 5 and 10 mg/day significantly lowered low-density lipoprotein-cholesterol (LDL-C) (p<0.0001 and p<0.00001), the main efficacy variable, by 18.6% and 30.2%, while Octa-60 significantly reduced (p<0.05) LDL-C by 10.0% at study completion only. The frequency of policosanol patients reaching reductions of LDL-C > or = 15% after 5 mg/day (37/55; 67.3%) and 10 mg/day (47/55; 88.7%) was greater (p<0.01 and p<0.01) than in the Octa-60 group, which was 5/55 (9.1%) and 20/55 (36.4%). Likewise, the frequency of patients reaching LDL-C values of <3.4 mmol/l at study completion was greater (p<0.001) in the policosanol group (39/55, 70.9%) than in the Octa-60 group (6/55, 10.9%). Policosanol 5 and 10 mg/day significantly lowered (p<0.00001) total cholesterol (TC) (13.4% and 20.4%), LDL-C/high-density lipoprotein-cholesterol (HDL-C) (22.1% and 37.0%) and TC/HDL-C (17.2% and 28.2%). Octa-60 at 10 mg/day lowered (p<0.05) TC (8.7%), LDL-C/HDL-C (12.6%) and TC/HDL-C (9.4%). HDL-C was increased (p<0.001 and 0.0001) by policosanol 5 and 10 mg/day (5.6% and 12.5%) but was unchanged by Octa-60. In both groups, triglycerides remained unchanged. Both treatments were safe and well tolerated. Octa-60, but not policosanol, significantly increased glucose and alanine aminotransferase, but individual values were within the normal range. Four patients (two from each group) discontinued the trial, but only one (in the Octa-60 group) did so because of an adverse event (AE) (skin rash). Overall, three patients (all from the Octa-60 group) reported AEs. In conclusion, original policosanol at 5 and 10 mg/day, but not Octa 60, was effective in patients with type II hypercholesterolemia. Thus, policosanol reached the efficacy criterion for LDL-C reduction in both steps, while Octa-60 failed to reach this goal. In addition, policosanol was better tolerated than Octa-60.     

不同剂量氟伐他汀调整高脂血症疗效比较

目的 :研究不同剂量氟伐他汀调整高脂血症的疗效及不良反应。方法 :氟伐他汀 4 0mgq .n .组 37例 ,2 0mgq .n .组33例 ,服药 4周。结果 :4 0mg组服药后血清总胆固醇降低32 .4 % ,2 0mg组降低15 .7% ,P <0 .0 5。两组降低甘油三酯及升高高密度脂蛋白胆固醇的差异不显著。结论 :氟伐他汀 4 0mgq .n .降低血清总胆固醇的作用明显优于氟伐他汀 2 0mgq .n .。     

阿托伐他汀与氟伐他汀治疗高胆固醇血症的对比研究

目的　探讨阿托伐他汀 (立普妥 )与氟伐他汀 (来适可 )对高胆固醇血症病人疗效及安全性。方法　 10 0例高胆固醇血症随机分成阿托伐他汀组 5 0例和氟伐他汀组 5 0例 ,治疗 6周后观察比较。结果　阿托伐他汀及氟伐他汀均能明显降低TC、TG、LDL C水平 (P <0 0 1或P <0 0 5 ) ,阿托伐他汀降TC、TG、LDL C的作用强于氟伐他汀 (P <0 0 5 ) ,两药均能升高HDL C水平 (P <0 0 5 ) ,但两组比较未达到显著差异 (P >0 0 5 )。两药不良反应均比较小 ,耐受性好。结论　阿托伐他汀降TC、TG、LDL C的作用优于氟伐他汀 ,但升高HDL C水平相似 ,两药均有良好的安全性。     

Cost-Effectiveness Analysis of Cholesterol-Lowering Therapies in Spain

OBJECTIVE: To assess the cost efficacy of atorvastatin, simvastatin, lovastatin, fluvastatin, pravastatin, and colestyramine in the reduction of low-density lipoprotein-cholesterol (LDL-C) levels and the cost per patient to achieve the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) therapeutic objectives in Spain. METHOD: The following treatments were evaluated: atorvastatin, simvastatin, and pravastatin 10-40 mg/day; lovastatin and fluvastatin 20-80 mg/day; and colestyramine 12-24 g/day. The cost effectiveness of these treatments was evaluated, in terms of cost per percentage of LDL-C reduction, by comparing annual treatment costs versus the efficacy of LDL-C reduction. Treatment costs included medication costs (2003 wholesale prices), control measures, and the treatment of adverse affects. The efficacy of HMG-CoA reductase inhibitors (statins) was obtained from a meta-analysis of results obtained from clinical trials published between 1993 and 2003 that met the following criteria: monotherapy; >16 weeks of treatment; randomized allocation of individuals to the intervention and comparator groups; dietary treatment for > or =3 months before administration of medication; and double-blind measurement of outcomes. Average and incremental cost-effectiveness ratios were calculated to assess the efficiency of cholesterol-lowering treatments. RESULTS: Efficacy, in terms of percentage of LDL-C reduction, ranged from 10% for colestyramine 12 g/day to 49% for atorvastatin 40 mg/day. Total annual treatment costs ranged from euro 321 for fluvastatin 20 mg/day to euro 1151 for atorvastatin 40 mg/day. Cost-effectiveness ratios, in terms of cost per percentage of LDL-C reduced, were: euro 11-23 for atorvastatin; euro 12-21 for simvastatin; euro 14-22 for lovastatin; euro 15-24 for fluvastatin; euro 21-42 for pravastatin; and euro 35-46 for colestyramine. Atorvastatin 10 mg/day was the most cost-effective treatment, followed by simvastatin 10 mg/day, lovastatin 20 mg/day, and fluvastatin 20 mg/day. Atorvastatin was the most cost-effective treatment in the achievement of the NCEP ATP III LDL-C reduction objectives in patients with high (<100 mg/dL) and moderate (<130 mg/dL) risk of coronary heart disease (CHD), with a cost per patient of euro 747 and euro 405 per year, respectively. Fluvastatin was the most cost-effective treatment in the achievement of the NCEP ATPIII therapeutic objective in patients with low-risk of CHD (LDL-C <160 mg/dL), with a cost per patient of euro 321. CONCLUSION: Atorvastatin 10 mg/day was the most cost-effective cholesterol-lowering drug, followed by simvastatin 10 mg/day, lovastatin 20 mg/day, and fluvastatin 20 mg/day. The preferred statin should be atorvastatin in patients with moderate-to-high CHD risk and fluvastatin in patients with low risk for CHD.     

Long-Term Safety and Efficacy of a Combination of Niacin Extended Release and Simvastatin in Patients with Dyslipidemia

INTRODUCTION: High-dose HMG-CoA reductase inhibitors (statins) fail to prevent approximately two-thirds of cardiovascular events. This fact has focused increased attention on treating abnormalities of non-high-density lipoprotein-cholesterol (non-HDL-C), HDL-C, and triglycerides in national guidelines and has intensified interest in combination therapy. METHODS: The OCEANS study (Open-label evaluation of the safety and efficacy of a Combination of niacin ER and simvAstatin in patieNts with dySlipidemia; ClinicalTrials.gov identifier: NCT00080275) evaluated the safety and efficacy of a combination of niacin extended release and simvastatin (NER/S; SIMCOR) over 52 weeks in 520 patients with mixed dyslipidemia. After a >or=4-week run-in phase of diet modification and simvastatin 40 mg/day, median baseline values (mg/dL) were: non-HDL-C = 141, low-density lipoprotein-cholesterol (LDL-C) = 110, HDL-C = 45, and triglyceride = 151. Patients were randomized to an 8- or 12-week niacin titration scheme to a maximum NER/S dosage of 2,000/40 mg/day. RESULTS: Differences between titration groups in tolerability, safety, and efficacy were minimal; therefore, all results are for pooled titration groups. The safety of NER/S was consistent with the safety profile of each individual component. Treatment with NER/S was well tolerated: 71% of patients experienced flushing and 92% of flushing episodes were mild or moderate in intensity. Overall, 61% of patients experienced flushing episodes that were rated as mild or moderate in intensity. Flushing decreased over time: <40% of those who had flushing during titration experienced flushing during the final 12 weeks. A total of 20% of patients discontinued treatment because of a treatment-related adverse event, including 7% who discontinued because of flushing. Median changes from baseline (following the simvastatin 40 mg/day run-in phase) to 24 weeks were: non-HDL-C = -27.3%, LDL-C = -25.0%, HDL-C = +23.9%, and triglycerides = -35.9% (all p < 0.0001 vs baseline). In lipid-treatment-naive patients, NER/S 2,000/40 mg/day decreased non-HDL-C, LDL-C, and triglycerides by approximately 50% and increased HDL-C by approximately 25% when week-24 lipid values were compared with lipid values obtained prior to the simvastatin 40 mg/day run-in. All three therapeutic lipid targets (LDL-C [risk-adjusted goal], HDL-C >or=40 mg/dL, and triglycerides <150 mg/dL) were achieved concurrently by 65% of patients treated with NER/S. CONCLUSION: Treatment with NER/S 2,000/40 mg/day is well tolerated, has no unanticipated adverse events, and provides additional, clinically relevant improvements in multiple lipid parameters beyond statin monotherapy.     

A Comparison of Fluvastatin 40 mg Every Other Day versus 20 mg Every Day in Patients with Hypercholesterolemia

Study Objective . To assess the efficacy of fluvastatin administered every other day versus an equivalent dose given daily in patients with hypercholesterolemia. Design . Randomized, nonblinded, crossover study. Setting . Veterans Affairs Medical Center. Patients . Twenty-three patients with low-density lipoprotein (LDL) levels above 160 mg/dl despite diet therapy. Intervention . Patients received fluvastatin 40 mg every other day or 20 mg/day, all doses taken at bedtime. Each treatment arm was 6 weeks in duration. Measurements and Main Results . A lipid profile was determined at baseline and after each regimen. Both regimens significantly lowered total cholesterol and LDL versus baseline. The LDL levels were lowered by 24% and 21% by fluvastatin 20 mg/day and 40 mg every other day, respectively. There was no statistically significant difference in lipid components between regimens. Conclusion . Fluvastatin 40 mg every other day is effective in lowering total cholesterol and LDL in patients with hypercholesterolemia.     

Cerivastatin gender effect: sub-analyses of results from a multinational, randomised, double-blind study. Cerivastatin Study Group

We previously reported the results of a multicentre, randomised, double-blind, parallel-group study comparing the efficacy and safety of cerivastatin 0.4 mg/day and cerivastatin 0.2 mg/day in patients with primary hypercholesterolaemia. Exploratory analysis in this study suggested a gender difference in the 0.4 mg group: mean low-density lipoprotein cholesterol (LDL-C) decreased by 44.4 +/- 8.9% in women, compared with a mean decrease of 37.0 +/- 0.9% in men (p < 0.046). This paper reports the results of further sub-analyses from this study. Overall in the per-protocol (PP) population, 71.5% (n = 73) of women taking cerivastatin 0.4 mg had an LDL-C decrease of > 40%, compared with 38.0% (n = 76) of men taking the same dose. In the cerivastatin 0.2 mg PP population, 34% (n = 17) of women had an LDL-C decrease of > 40%, compared with 19% (n = 18) of men. Mean LDL-C/HDL-C ratio decreased by 43% from baseline to the end of the study in the cerivastatin 0.4 mg PP group: -41.3% in males vs. -48.3% in females. In the cerivastatin 0.2 mg group, the decrease in LDL-C/HDL-C ratio from baseline to endpoint did not markedly differ between genders: -37.0% for males vs. -37.3% for females. Categorial analysis of the LDL-C/HDL-C ratio found that 90% of PP patients taking cerivastatin 0.4 mg, and 84% of PP patients taking cerivastatin 0.2 mg, had a low CHD risk (defined as a LDL-C/HDL-C ratio < or = 3) after 8 weeks of treatment. The 6th and 95th percentiles of the distribution of LDL-C reduction from baseline revealed that 90% of PP patients taking cerivastatin 0.4 mg had an LDL-C reduction of between 22% and 56%. The mean LDL-C reduction for this 90% subset of patients was 40.1%. The same analysis for PP patients taking cerivastatin 0.2 mg found that 90% had an LDL-C reduction of between 13% and 49%. The mean LDL-C reduction in this 90% subset of patients was 31.5%. Of the patients taking cerivastatin 0.4 mg and valid for treatment according to National Cholesterol Education Program (NCEP) criteria, 71% (149/211) achieved NCEP targets for LDL-C at Week 16.     

Cerivastatin Gender Effect: Sub-analyses of Results from a Multinational,Randomised, Double-blind Study

Summary

We previously reported the results of a multicentre, randomised, double-blind, parallelgroup study comparing the efficacy and safety of cerivastatin 0.4?mg/day and cerivastatin

0.2?mg/day in patients with primary hypercholesterolaemia. Exploratory analysis in this study suggested a gender difference in the 0.4 mg group: mean low-density lipoprotein cholesterol (LDL-C) decreased by 44.4 ± 8.9% in women, compared with a mean decrease of 37.0 ± 0.9% in men (p < 0.046). This paper reports the results of further sub-analyses from this study. Overall in the per-protocol (PP) population, 71.5% (n = 73) of women taking cerivastatin 0.4 mg had an LDL-C decrease of > 40%, compared with 38.0% (n = 76) of men taking the same dose. In the cerivastatin 0.2 mg PP population, 34% (n = 17) of women had an LDL-C decrease of > 40%, compared with 19% (n = 18) of men. Mean LDL-C/HDL-C ratio decreased by 43% from baseline to the end of the study in the cerivastatin 0.4 mg PP group: –41.3% in males vs. –48.3% in females. In the cerivastatin 0.2 mg group, the decrease in LDL-C/HDL-C ratio from baseline to endpoint did not markedly differ between genders: –37.0% for males vs. –37.3% for females. Categorial analysis of the LDL-C/HDL-C ratio found that 90% of PP patients taking cerivastatin 0.4 mg, and 84% of PP patients taking cerivastatin 0.2 mg, had a low CHD risk (defined as a LDL-C/HDL-C ratio ≤ 3) after 8 weeks of treatment. The 6thand 95th percentiles of the distribution of LDL-C reduction from baseline revealed that 90% of PP patients taking cerivastatin 0.4 mg had an LDL-C reduction of between 22% and 56%. The mean LDL-C reduction for this 90% subset of patients was 40.1%. The same analysis for PP patients taking cerivastatin

0.2 mg found that 90% had an LDL-C reduction of between 13% and 49%. The mean LDL-C reduction in this 90% subset of patients was 31.5%. Of the patients taking cerivastatin 0.4 mg and valid for treatment according to National Cholesterol Education Program (NCEP) criteria, 71% (149/211) achieved NCEP targets for LDL-C at Week 16.     

A pharmacoeconomic evaluation of statins in the treatment of hypercholesterolaemia in the primary care setting in Spain

BACKGROUND: Cardiovascular disease is one of the leading causes of death and it has been shown that primary prevention with the HMG-CoA reductase inhibitor (statin) lipid-lowering drugs can reduce cardiovascular events. Acquisition costs vary between statins and this may be an important consideration in the overall cost effectiveness (CE) of different options. OBJECTIVE: To perform a CE study of the main statins used in Spain for primary prevention of cardiovascular disease in patients with high cholesterol levels [corrected] STUDY DESIGN: The CE analysis was based on an open-label, prospective, naturalistic, randomised intervention study under usual care conditions in primary care settings in patients with high cholesterol levels (total cholesterol [TC] >240 mg/dL, low-density lipoprotein cholesterol [LDL-C] >160 mg/dL) and one or more cardiovascular risk factors. The analysis was conducted from the perspective of the Spanish National Health System; the year of costing was 2001. PATIENTS: A total of 161 patients (49.7% males), mean age 65 +/- 10.3 years, without evidence of cardiovascular disease were included in the study. Of those, 82.1% were hypertensive, 37.1% had diabetes mellitus and 17.9% were smokers. INTERVENTIONS: Forty-eight patients received oral atorvastatin 10 mg/day, 32 received fluvastatin 40 mg/day, 44 received simvastatin 20 mg/day and 37 patients received pravastatin 20 mg/day for 6 months. MAIN MEASUREMENTS AND RESULTS: After 6 months, the therapeutic goals of LDL-C control, according to the recommendations of the Spanish Society of Arteriosclerosis--Consensus-2000, were reached in 62.5%, 43.8%, 45.5% and 40.5% of patients treated with atorvastatin, fluvastatin, simvastatin and pravastatin, respectively. The average CE ratio, expressed as the cost in euros (euro) per patient achieving the therapeutic goals, was euros 424.3 for atorvastatin, euros 503.5 for fluvastatin, euros 527.0 for simvastatin and euros 683.4 for pravastatin. The incremental CE ratios for atorvastatin versus fluvastatin and simvastatin were euros 238.9 and euros 149.5, respectively, per additional patient reaching therapeutic goals. Atorvastatin, fluvastatin and simvastatin all dominated pravastatin. CONCLUSIONS: All the statins studied have been shown to be effective for reducing both TC and LDL-C levels. In this study, atorvastatin was the most efficient drug, with the best CE ratio (cost per patient reaching therapeutic goals). Atorvastatin was more effective and less costly than pravastatin, and when compared with fluvastatin or simvastatin the additional cost per additional patient achieving therapeutic goals was 相似文献   

Efficacy and safety of the 200–300 mg sustained release formulation of diltiazem administered once daily in patients with stable angina

The aim of this multicentre randomised double blind study was to compare the efficacy and safety of the 200–300 mg sustained release diltiazem formulation administered once daily (200–300 SR) with standard diltiazem (D) given three or four times daily to patients with stable angina. Patients aged 59 years, with a reproducible exercise test on placebo, were randomised to 4 weeks of treatment with 200–300 SR (n=70) or D (n=74). The initial dosage was 200 mg in the 200–300 SR group and 60 mg t.i.d. in the D group, increased to 300 mg once daily or 60 mg q.i.d., respectively, if ergometric parameters, which were always measured at the end of the dosing period, had not improved after two weeks. After 4 weeks of treatment, the antianginal efficacy at rest was comparable in the 200–300 SR and the D group; there was a prolongation of the total duration of exertion of 14% and 18% respectively (P<0.01 vs placebo for both groups with no intergroup difference). A dose-effect relation was found with both formulations.The 200–300 SR formulation gave full 24 hour anti-ischaemic protection when administered once daily. Its efficacy and safety were comparable to those of standard diltiazem t.i.d. or q.i.d. in patients with stable angina. The once daily administration should improve treatment compliance.     

Effects of policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia associated with type 2 diabetes mellitus

In this pilot, randomized, double-blind study, we compared the effects of policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia and type 2 diabetes mellitus. After 4 weeks on a cholesterol-lowering diet, 36 patients were randomized to policosanol (10 mg/day) or lovastatin (20 mg/day) tablets o.i.d. for 8 weeks. Policosanol significantly (p < 0.001) lowered serum low-density lipoprotein-cholesterol (LDL-C) (29.9%), total cholesterol (21.1%), triglycerides (13.6%) and the LDL-C/high-density lipoprotein-cholesterol (HDL-C) (36.7%) and total cholesterol/HDL-C (28.9%) ratios and significantly (p < 0.01) increased HDL-C (12.5%). Lovastatin significantly (p < 0.001) lowered LDL-C (25%), total cholesterol (18%), triglycerides (10.9%) and the LDL-C/HDL-C (30.4%) and total cholesterol/HDL-C ratios (23.9%) and significantly (p < 0.01) raised HDL-C (8.3%). Policosanol was more effective (p < 0.05) than lovastatin in reducing both ratios and in increasing (p < 0.05) HDL-C. Policosanol, but not lovastatin, significantly raised the lag time (20.9%) of Cu+2-induced LDL peroxidation and total plasma antioxidant activity (24.2%) (p < 0.05). Both policosanol and lovastatin significantly decreased the propagation rate (41.9% and 41.6% respectively, p < 0.001), maximal diene production (8.3% and 5.7%) and plasma levels of thiobarbituric acid reactive substances (9.7% and 11.5%, p < 0.001). Both treatments were well tolerated. Only one patient in the lovastatin group withdrew from the trial due to adverse events. In conclusion, policosanol and lovastatin administered short term to patients with dyslipidemia secondary to type 2 diabetes were effective in lowering cholesterol and in inhibiting the extent of lipid peroxidation. Policosanol (10 mg/day) was slightly more effective than lovastatin (20 mg/day) in reducing the LDL-C/HDL-C and total cholesterol/HDL-C ratios, in increasing HDL-C levels and in preventing LDL oxidation. Nevertheless, since this was a pilot study, further clinical studies performed in larger sample sizes of diabetic patients are needed for definitive conclusions.