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1.
AIMS: To evaluate the efficacy and safety of ezetimibe 10 mg administered with pravastatin in patients with primary hypercholesterolemia. METHODS AND RESULTS: After dietary stabilization, 2-12 week screening/washout period, and 4-week, single-blind, placebo lead-in period, 538 patients with baseline LDL-C > or =3.8 to < or =6.5 mmol/l and TG < or =4.0 mmol/l were randomized to one of eight possible treatments administered daily for 12 weeks: ezetimibe 10mg; pravastatin 10, 20, or 40 mg; ezetimibe 10 mg plus pravastatin 10, 20, or 40 mg; or placebo. The primary efficacy endpoint was percent reduction in LDL-C from baseline to study endpoint for ezetimibe 10 mg plus pravastatin (pooled doses) compared to pravastatin alone (pooled doses) and ezetimibe alone. The combined use of ezetimibe and pravastatin resulted in significant incremental reductions in LDL-C and TG compared to pooled pravastatin alone (p<0.01). Coadministration therapy reduced LDL-C by 34-41%, TG by 21-23%, and increased HDL-C by 7.8-8.4%, depending on the dose of pravastatin. The combined regimen was well tolerated, with a safety profile similar to pravastatin alone and placebo. CONCLUSIONS: When coadministered with pravastatin, ezetimibe provided significant incremental reductions in LDL-C and TG and was well tolerated with a safety profile similar to pravastatin alone.  相似文献   

2.
This 1-year, double-blind, active-controlled, multicenter study compared the efficacy and safety of atorvastatin to pravastatin and evaluated their ability to achieve target low-density lipoprotein cholesterol (LDL-C) levels in patients with hypercholesterolemia. Patients were stratified to risk factor groups based upon European Atherosclerosis Society (EAS) guidelines before randomization to atorvastatin 10 or 20 mg or pravastatin 20 or 40 mg once daily. Target LDL-C levels for patients with mild/moderate risk and severe risk were <130 mg/dl (3.4 mmol/l) and <115 mg/dl (3.0 mmol/l), respectively. If needed to achieve target levels both drugs were uptitrated within the approved dose range. Mean changes from LDL-C levels were 39% for atorvastatin patients compared to 29% for pravastatin-treated patients (p<0.0001). The number of patient responders (those reaching LDL-C goals) was higher (p<0.0001) for atorvastatin patients (91% at any study visit and 51% at the last study visit) than for pravastatin patients (48% and 20%, respectively). The daily atorvastatin dose used by most patients after the titration phase was 10 mg and the respective pravastatin dose was 40 mg. Both drugs were well-tolerated and had similar adverse event profiles. Atorvastatin, in the approved dose range, will allow a greater number of patients to reach established LDL-C treatment goals with single drug therapy.  相似文献   

3.
目的:探讨普伐他汀、阿托伐他汀对不稳定型心绞痛(UA)患者C反应蛋白和血脂的影响。方法:106例不稳定型心绞痛患者被随机分为普伐他汀组(53例)及阿托伐他汀组(53例),测定治疗前,治疗8周后C反应蛋白和血脂的变化。结果:两组治疗前后C反应蛋白(CRP)和血脂均有显著下降(P<0.05),且阿托伐他汀组较普伐他汀组血脂下降更显著(P<0.05)。结论:普伐他汀、阿托伐他汀均可降低UA患者CRP及血脂水平,同剂量阿托伐他汀较普伐他汀降脂效果更显著,其抗炎作用不依赖降脂作用。  相似文献   

4.
Ge CJ  Lu SZ  Chen YD  Wu XF  Hu SJ  Ji Y 《Heart and vessels》2008,23(2):91-95
Our aim in this study was to investigate the changes of serum high-sensitive C-reactive protein (hs-CRP) and uric acid (UA), and evaluate the synergistic effect of amlodipine and atorvastatin on blood pressure and left ventricular remodeling in hypertensive patients with primary hypercholesterolemia. One hundred and twenty-six hypertensive patients with hypercholesterolemia were randomized into amlodipine group (10 mg/day, group A, n = 65) and amlodipine (10 mg/day) plus atorvastatin group (20 mg/day, group B, n = 61), treated for 4 months continuously. Serum concentrations of total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, hs-CRP, and UA were determined, and blood pressure of both groups was examined before and after treatment. Left ventricular posterior wall thickness and interventricular spectum thickness were measured by echocardiography, and left ventricular mass index (LVMI) was calculated. After 4-months of treatment with atorvastatin, serum concentrations of total cholesterol, low-density lipoprotein cholesterol, triglycerides, hs-CRP, and UA were significantly decreased in group B (P < 0.05, P < 0.01), while serum concentrations of high-density lipoprotein cholesterol was elevated (P < 0.05). Meanwhile, systolic blood pressure and diastolic blood pressure were reduced in both groups (P < 0.05), and blood pressure in group B was markedly lower than that in group A after treatment (P < 0.05). Compared with that before treatment, LVMI in both groups decreased (P < 0.05), to a significantly lower degree in group B than in group A (P < 0.05). Atorvastatin can decrease serum concentrations of hs-CRP and UA. The amlodipine-atorvastatin combination markedly reduces blood pressure and reverses left ventricular hypertrophy more than amlodipine monotherapy. The positive effect suggests that in hypertensive and hypercholesterolemic patients, the combination of amlodipine and atorvastatin could be the treatment of choice.  相似文献   

5.
目的应用基因芯片比较普伐他汀和阿托伐他汀对糖尿病大鼠动脉组织基因谱差异性表达的影响。方法2004年5~12月将同济大学附属东方医院45只SD雄性大鼠随机分为正常对照组9只,另36只用链尿佐菌素与枸橼酸缓冲液配成1%溶液,实施糖尿病造模,造模成功后分为糖尿病对照组、糖尿病普伐他汀治疗组和糖尿病阿托伐他汀治疗组各12只[普伐他汀和阿托伐他汀分别50mg/(kg.d),共4周],取其胸主动脉,用Cy3和Cy5两种荧光染料通过逆转录反应将动脉的mRNA分别标记成2种探针,并与载有1组靶基因的基因芯片进行杂交,通过计算机扫描分析得出差异表达的某些基因。结果糖尿病普伐他汀治疗组75条基因有差异性表达,阿托伐他汀治疗组285条基因有差异性表达。两组之间有28条基因有共同的表达趋势。结论普伐他汀和阿托伐他汀在多环节上有抗糖尿病血管病变的作用,两者之间有一定差异。  相似文献   

6.
Pravastatin in diabetes-associated hypercholesterolemia   总被引:2,自引:0,他引:2  
Patients with diabetes mellitus (DM), type 1 and type 2, have an increased risk of coronary heart disease as a result of accelerated atherosclerosis. Dyslipid-emia, often found in these patients, plays an important role in this process. This study investigates the efficacy and safety of lipid-lowering therapy with pravastatin, a 3-HMG-Coenzym A reductase inhibitor in hypercholesterolemic type-1 and type-2 diabetic patients. Of 49 patients (22 type-1 DM and 27 type-2 DM), 24 patients were treated with pravastatin, 20 mg/day, and 25 patients with placebo. After 24 weeks, total cholesterol (TC) was decreased by 22.2%, low-density lipoprotein (LDL) cholesterol by 25.8% and triglycerides (TG) by 13.6%. Pravastatin treatment did not induce a significant change in high-density (HDL) cholesterol levels. No differences in effects of pravastatin treatment on serum lipids and lipoproteins were found with respect to the diabetes type. No serious side effects occurred and pravastatin treatment did not cause any deterioration in glycemia control. The data suggest that pravastatin is effective and safe in the treatment of dyslipidemia in both type-1 and type-2 diabetic patients. Received: 20 December 1996 / Accepted in revised form: 1 October 1997  相似文献   

7.
This study compared the efficacy and safety of co-administered ezetimibe + simvastatin with atorvastatin monotherapy in adults with hypercholesterolemia. Seven hundred eighty-eight patients were randomized 1:1:1 to 3 treatment groups; each group was force-titrated over four 6-week treatment periods: (1) 10 mg of atorvastatin as the initial dose was titrated to 20, 40, and 80 mg; (2) co-administration of 10 mg of ezetimibe and 10 mg of simvastatin (10/10 mg) was titrated to 10/20, 10/40, and 10/80 mg of ezetimibe + simvastatin; and (3) co-administration of 10/20 mg of ezetimibe + simvastatin was titrated to 10/40 mg (for 2 treatment periods) and 10/80 mg of ezetimibe + simvastatin. Key efficacy measures included percent changes in low-density lipoprotein cholesterol (LDL) and high-density lipoprotein cholesterol (HDL) from baseline to the ends of (1) treatment periods 1 and 2 (for LDL cholesterol) comparing co-administration of 10/20 mg and 10/10 mg of ezetimibe + simvastatin with 10 mg of atorvastatin and (2) treatment period 4 (for LDL cholesterol and HDL cholesterol) comparing co-administration of 10/80 mg of ezetimibe + simvastatin with 80 mg of atorvastatin. Baseline LDL and HDL cholesterol levels were comparable between treatment groups. At the end of treatment period 1, the mean decrease of LDL cholesterol was significantly (p ≤0.001) greater for co-administration of 10/10 mg and 10/20 mg of ezetimibe + simvastatin than for 10 mg of atorvastatin. At the end of treatment period 4 and after comparing maximum doses, co-administration of 10/80 mg of ezetimibe + simvastatin was superior to 80 mg of atorvastatin in the percent LDL cholesterol decrease (−59.4% vs −52.5%, p <0.001) and HDL cholesterol increase (12.3% vs 6.5%; p <0.001). All treatments were well tolerated. Thus, a greater LDL cholesterol decrease and HDL cholesterol increase were attained by treating patients with co-administration of ezetimibe and simvastatin than with atorvastatin.  相似文献   

8.
目的 观察阿托伐他汀治疗非酒精性脂肪性肝病(NAFLD)的疗效及安全性.方法 选择72例非酒精性脂肪性肝病患者,共68例患者按规定要求完成试验.所有患者基线丙氨酸转氨酶(ALT)及总胆固醇(TC)水平均高于正常值.随机分为治疗组38例、对照组30例.予治疗组患者阿托伐他汀10 mg/d(TC≤6.5 mmol/L)或20 mg/d(TC>6.5 mmol/L)口服.对照组患者则不予给药.记录两组患者基线水平及治疗6个月时的症状积分、体重指数(BMI)、血TC水平、ALT水平及B超测量肝密度.结果 治疗组基线期和6个月时的症状积分分别为11.05±1.29和6.08±0.87,差异有统计学意义(t=1.96,P<0.05).经6个月治疗.治疗组中11例患者ALT水平恢复正常,对照组中仅2例患者ALT水平恢复正常,差异有统计学意义(P<0.05).治疗组基线及6个月时的TC水平分别为(6.65±0.5)和(5.4±0.5)mmol/L,两者间差异有统计学意义(t=1.72,P<0.05).治疗组基线及6个月时的BMl分别为(26.8±2.9)和(26.4±2.8)kg/m~2,对照组则分别为(26.5±2.3)和(26.4±2.2)kg/m~2,两者间差异均无统计学意义(P值均>0.05).治疗组及对照组基线及6个月时的B超肝密度分级差异亦无统计学意义(P值均>0.05).试验中未观察到明显不良反应.结论 NAFLD患者经阿托伐他汀治疗后,血清ALT水平及TC水平均显著下降.合并高胆固醇血症的NAFLD患者选用阿托伐他汀治疗安全有效.  相似文献   

9.
普伐他汀治疗肾病综合征高脂血症35例临床分析   总被引:1,自引:0,他引:1  
目的:总结普伐他汀治疗肾病综合征高脂血症的疗效。方法:对35例伴肮脂血症的肾病综合征患者在用强的松、利尿、降压、抗凝治疗的同时,每晚给予普伐他汀10mg,连续1个月。其间停用其他降脂药。治疗前后测定病人血清CH、TG、LDL-C和GDL-C。结果:治疗1个月后血CH、TG、LDL-C均显著下降(P<0.01),HDL-C则升高(P<0.05)。未见有不良反应.结论:普伐他汀有显著降血脂作用,特别适用于治疗高胆固醇血症及LDL-C升高者。  相似文献   

10.
阿托伐他汀对冠心病患者的血管舒张功能的影响   总被引:2,自引:0,他引:2  
目的观察阿托伐他汀对冠心病患者血管舒张功能的作用。方法将入选60例冠心病并高胆固醇血症患者随机分为阿托伐他汀治疗组(A组)和对照组(B组)。分别测定血清胆固醇、三酰甘油、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇。并应用高分辨率超声技术,检测治疗前、后两组肱动脉血流介导和硝酸甘油介导的舒张功能。结果治疗前,冠心病并高胆固醇血症患者肱动脉血流介导和硝酸甘油介导的舒张功能均低于健康对照组(P<0.01)。经阿托伐他汀治疗6个月后A组血浆总胆固醇、三酰甘油和低密度脂蛋白胆固醇显著降低(P<0.01),高密度脂蛋白胆固醇显著升高(P<0.01)。随着血脂的改善,肱动脉内皮依赖性血管舒张功能显著提高(P<0.01),但硝酸甘油介导的血管舒张功能未见改善(P>0.05)。结论冠心病并高胆固醇血症患者存在内皮依赖性血管舒张功能障碍,经阿托伐他汀调脂治疗后,受损的内皮依赖性血管舒张功能得到明显改善。  相似文献   

11.
12.
13.
This multicenter, double-blind, placebo-controlled, dose-response study was conducted in patients with primary hypercholesterolemia to examine the effects of pravastatin, a selective inhibitor of HMG-CoA reductase, on plasma lipids and lipoproteins. A total of 306 patients on cholesterol-lowering diets received twice daily doses of 5 mg, 10 mg, 20 mg pravastatin, or placebo for 12 weeks. Marked reductions in low density lipoprotein (LDL) cholesterol and total cholesterol were observed after 1 week of treatment; maximum lipid-lowering effects occurred at 4 weeks and were sustained for the duration of the trial. At week 12, pravastatin treatment resulted in dose-dependent mean reductions from baseline in LDL cholesterol of 17.5%, 22.9%, and 30.8% for the 3 doses tested (P less than or equal to 0001 compared with baseline and placebo). The reduction in LDL cholesterol was log-linear with respect to dose; each doubling of dose reduced LDL cholesterol an additional 6.5%. Dose-dependent reductions in total cholesterol from 12.9% to 23.3% also occurred (P less than or equal to 0.001). Triglycerides decreased by as 15.4% (P less than or equal to 0.001) and high-density lipoprotein (HDL) cholesterol increased approximately 7% (P less than or equal to 0.01), but these effects were not dose-dependent. No patient receiving pravastatin was discontinued during the 12-week trial. Transient episodes of rash and headache occurred. Slight increases in mean serum levels of ASAT and ALAT occurred, and 2% of both placebo- and pravastatin-treated patients reported myalgia although there was no clinically significant elevation of creatine kinase. These data indicate that pravastatin favorably affects all lipid parameters and is well tolerated.  相似文献   

14.
阿托伐他汀治疗高脂血症的疗效与安全性(附106例报告)   总被引:4,自引:0,他引:4  
刘志福  杨光  甄德民 《山东医药》2003,43(10):15-17
对 10 6例高脂血症患者应用阿托伐他汀治疗 ,起始剂量 10 mg/ d,4周后未达标者增至 2 0 mg/ d,共观察8周。治疗结果 :总胆固醇 ( TC)降低 3 4% ,低密度脂蛋白 ( L DL- C)降低 3 0 % ,甘油三酯 ( TG)降低 3 2 % ,动脉硬化指数 ( TC- HDL- C) / HDL- C降低 48%。脂蛋白〔 L p ( a)〕降低 2 4%。高密度脂蛋白 ( HDL- C)升高 2 9%。同治疗前相比 ,均有显著差异 ( P <0 .0 5 )。治疗后 :血浆粘度由 ( 1.668± 0 .43 ) m Pa.s降至 ( 1.0 63± 0 .67) m Pa.s,高切全血还原粘度由 ( 4.75 9± 1.8) m Pa.s降至 ( 3 .98± 0 .65 ) m Pa.s,治疗前后有显著差异 ( P <0 .0 5 ) ;高切、低切全血粘度 ,低切全血还原粘度 ,血小板聚集率 ( MPAG)分别降低 ( 0 .793± 0 .4) m Pa.s,( 2 .6±0 .2 ) m Pa.s,( 1.45 4± 0 .4) m Pa.s,( 16± 11) % ,但与治疗前相比均无显著差异 ( P均 >0 .0 5 )。红细胞压积( HCT)无影响。认为阿托伐他汀有显著降低 TC、TG、L DL- C、L p( a) ,升高 HDL- C的疗效 ,可改善血液流变学指标 ,且不良反应轻微  相似文献   

15.
BACKGROUND: Patients with homozygous familial hypercholesterolemia (HoFH) have a high incidence of cardiovascular morbidity and mortality from premature atherosclerosis, and the efficacy of pharmacological therapy has been limited. We evaluated the efficacy, safety, and tolerability of ezetimibe, a novel cholesterol absorption inhibitor, in a multicenter, double-blind, randomized trial of HoFH patients receiving atorvastatin or simvastatin. Methods and Results- Fifty patients with a diagnosis of HoFH on the National Cholesterol Education Program Step 1 or stricter diet and taking open-label atorvastatin 40 mg/d or simvastatin 40 mg/d (statin-40) with (n=25) or without (n=25) concomitant LDL apheresis were randomized to 1 of 3 double-blind treatments: atorvastatin or simvastatin 80 mg/d (statin-80, n=17); ezetimibe 10 mg/d plus atorvastatin or simvastatin 40 mg/d (n=16); or ezetimibe 10 mg/d plus atorvastatin or simvastatin 80 mg/d (n=17) for 12 weeks. The primary end point was mean percentage change in LDL cholesterol (LDL-C) from statin-40 baseline to the end point for patients receiving statins alone (statin-80) versus patients receiving ezetimibe plus atorvastatin or simvastatin at either dose (ezetimibe plus statin-40/80). Ezetimibe plus statin-40/80 significantly reduced LDL-C levels compared with statin-80 (-20.7% versus -6.7%, P=0.007). In the high-dose statin cohorts, ezetimibe plus statin-80 reduced LDL-C by an additional 20.5% (P=0.0001) versus statin-80. Similar significant reductions in LDL-C concentrations were observed for patients with genotype-confirmed HoFH (n=35). Ezetimibe was safe and well tolerated. CONCLUSIONS: Ezetimibe coadministered with atorvastatin or simvastatin in patients with HoFH produced clinically important LDL-C reductions compared with best current therapy. Ezetimibe provides a new, complementary pharmacological approach for this high-risk population.  相似文献   

16.
This 8-week multicenter, placebo-controlled trial compared the efficacy and safety of the HMG-CoA reductase inhibitor, pravastatin, when administered either as single doses of 40 mg in the morning (AM) or evening (PM) or 20 mg twice daily (bid) in 196 diet-stabilized outpatients with primary type II hypercholesterolemia. Mean reductions in total and low-density lipoprotein (LDL) cholesterol concentrations were observed in all pravastatin groups after 1 week and were sustained throughout the study (P less than or equal to 0.001 versus baseline and placebo). At week 8, mean reductions from baseline in the pravastatin treatment groups were 23-27% for total cholesterol and 30-34% for LDL cholesterol. LDL cholesterol was reduced greater than or equal to 15% by pravastatin in all patients in the group treated with 40 mg PM and in 88 and 96% in those receiving 20 mg bid and 40 mg AM, respectively. High density lipoprotein cholesterol was elevated (up to 8%) and triglycerides were reduced (up to 25%) by all pravastatin regimens (P less than or equal to 0.05). Pravastatin was well tolerated and was associated with a low incidence of adverse events. No patient withdrew from the study due to a pravastatin-related adverse event. Once-daily pravastatin is a safe and effective treatment for patients with primary hypercholesterolemia and has a favorable safety profile.  相似文献   

17.
目的 探讨非诺贝特和普伐他汀联合治疗混合性高脂血症的远期疗效及安全性。方法  38例确诊混合性高脂血症患者 ,联合应用非诺贝特和普伐他汀 (微粒化力平脂 2 0 0mg/d ,普拉固 10mg/d) ,进行为期 2年的治疗 ,治疗前后均测定空腹血脂、肌酸磷酸激酶 (CPK)、肝肾功能以及尿酸等指标 ,观察对患者的远期疗效和安全性。结果 联合治疗患者总胆固醇 (TC)显著下降 2 5 %± 6 % ,甘油三酯 (TG)下降 40 %± 5 % ,低密度脂蛋白 (LDL C)下降 2 7%± 3% ,高密度脂蛋白 (HDL C)上升 2 1%± 6 % ;谷丙转氨酶 (ALT)活性上升(3± 2 )U·L-1(无显著意义 ) ,CPK活性下降 (4± 8)U·L-1(无显著意义 ) ,无一例出现严重并发症。结论 非诺贝特联合普伐他汀治疗肝肾功能正常的混合性高脂血症患者是有效而且安全的。  相似文献   

18.
While a large numbers of clinical trials using various kinds of statins has been reported, a possible preventive effect on new onset of type 2 diabetes mellitus was shown only by the subanalysis of The West of Scotland Coronary Prevention Study (WOSCOPS) using pravastatin. The aim of this study was to investigate whether pravastatin has a preferable effect on glucose tolerance among statins. An open-label prospective cross-over trial was performed to compare the effect of pravastatin (10 mg/day) or atorvastatin (10 mg/day) in Japanese early-state type 2 diabetes mellitus with hypercholesterolemia. The analyzed study subjects were treated with pravastatin (10 mg/day, n = 12) or atorvastatin (10 mg/day, n = 12) for 12 weeks. After a 4-week-washout period, the drugs were switched and treatment was continued for another 12 weeks. Oral glucose tolerance test (OGTT) was performed to evaluate several parameters including the appropriateness of beta cell function for the individual insulin sensitivity (disposition index: product of a validated secretion parameter and sensitivity) at the end of each therapy. HbA(1c) and 2 h-glucose levels during OGTT in the pravastatin treatment were significantly lower than atorvastatin treatment. Disposition index after pravastatin treatment was significantly higher than after atorvastatin treatment. In conclusion, our study suggests that pravastatin has a favorable effect on pancreatic beta cell function compared with atorvastatin.  相似文献   

19.
西立伐他汀治疗原发性高胆固醇血症随机对照研究   总被引:4,自引:0,他引:4  
目的:比较不同剂量的西立伐他汀(cerivastatin)治疗国人原发性高胆固醇血症的疗效、安全性及耐受性。方法采用多中心,随机、双盲、安慰剂对照,平行组试验,所有入选停止其他降脂治疗且饮食控制达美国心脏协会Ⅰ级(AHA-STEP-I)或其相应标准,满4周后,接受单盲安慰剂治疗5周(A期)。安慰剂期后,470例患随机接受西立伐他汀0.1mg(n=119)、0.2mg(n=117)、0.3mg(  相似文献   

20.
大剂量阿托伐他汀治疗急性冠脉综合征的疗效及安全性   总被引:1,自引:0,他引:1  
目的:观察急性冠脉综合征(ACS)发生后24h内使用两种不同剂量阿托代他汀的疗效与安全性,以及患者1年中心脑血管事件的发生情况。方法:60例ACS患者被随机均分为两组,24h内分别给予阿托伐他汀20mg/d与60mg/d,用药时间1年。观察两组患者血脂变化情况、住院期间及存活出院者主要心脑血管事件及药物不良反应。结果:两组治疗2周、3个月、6个月及12个月的总胆固醇(TC)及低密度脂蛋白(LDL-C)均明显降低(P均0.01),且60mg/d组在各时间段的下降程度均优于20mg/d组(P均0.05),住院及随访期间60mg/d组复发性心绞痛(10.0%:30.0%)、心力衰竭(10.0%:26.7%)、心律失常发生率(13.3%:30.0%)均较20mg/d组明显降低(P均0.05)。两组未见严重不良反应。结论:ACS患者应用20mg/d及60mg/d的阿托伐他汀均能有效地调脂,60mg/d阿托伐他汀的调脂及减少心脏血管事件作用更佳,且治疗过程中无严重不良反应。  相似文献   

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