微粒化非诺贝特治疗高脂血症的临床观察

目的:观察微粒化非诺贝特对高脂血症的疗效与安全性。方法:用开放、随机对照方式,应用非诺贝特和多烯康治疗高脂血症12周,记录病人一般资料和治疗前后有关检查结果及副作用。结果:非诺贝特组服药12周后血清胆固醇(TC)、甘油三酯(TG)、低胆固醇脂蛋白(LDL-C)水平与O周比较分别降低18.9％(P相似文献   

消肝脂汤与非诺贝特治疗脂肪肝的临床观察

目的 :观察消肝脂汤与非诺贝特治疗脂肪肝的临床疗效。方法 :确诊脂肪肝的 70例患者随机分成两组。治疗组 3 6例 ,给予自拟消肝脂汤合非诺贝特治疗 ;对照组予单用非诺贝特治疗。比较两组疗效。结果 :治疗组治愈率为 5 8 3 3 % ,总有效率为 88 89% ;对照组分别为 3 2 3 5 % ,64 71%。两组比较差异有显著意义 (P <0 0 5 )。结论 :消肝脂汤合非诺贝特治疗脂肪肝效果优于单用非诺贝特。     

调脂治疗对冠心病病人血脂和心肌缺血影响的研究

目的：探讨调脂治疗在冠心病二级预防中．能否通过纠正血脂异常而发挥抗心肌缺血的有益作用和改善临床症状。方法：选择22例冠心病合并高三酰甘油（TG)、低高密度脂蛋白-胆固醇(HDL-C)血症病人应用非诺贝特治疗一月后．观察其治疗前后血脂和部分病人缺血总负荷的变化以及临床症状是否改善．缺血总负荷的变化指24小时内动态心电图发作性ST段水平型或下斜性压低≥1mm相加的总时间。结果：经非诺贝特治疗一月后．血TG水平明显下降(分别为3.14±0.9kmmol/L和1．16±0.40mmol／L，P<0.01)。血胆固醇(TC)水平也明显下降(分别为6.06±0.52mmol／L和5.38±0.28mmol／L,P<0.05)；调脂治疗前后血HDC-C、HDL2-C和HDL3-C则分别为0.85±0.14、0．26±0.16、0．67±0.17mmol／L和1.15±0.28、0.39±0.15、0．75±0.18mmol／L，三项指标治疗前后均有显性差异(均P<0．05)。7例缺血总负荷的变化为：3例发作性ST段下移均有降低．4例呈固定性ST段下移则无明显改变。11例病人硝酸酯类制剂用量和胸痛发作减少。结论：调脂药非诺贝特能显降低冠心病病人血TG和TC水平．升高HDL水平．并可能对改善心肌缺血发挥有益作用。     

大剂量辛伐他汀与其联合非诺贝特对糖尿病高脂血症患者降脂疗效的临床观察

目的探讨辛伐他汀与非诺贝特联合对改善糖尿病高脂血症患者血脂谱是否优于大剂量辛伐他汀类单独应用及其用药安全性。方法选取60名糖尿病合并混合高脂血症经辛伐他汀20 mg每晚1次,治疗至少8周后血脂不达标(达标标准:LDL-C<2.6 mmol/L、TG<1.7 mmol/L、HDL-C>1.2 mmol/L)的患者随机分为大剂量辛伐他汀治疗组(辛伐他汀40 mg、每晚1次,n=30)和辛伐他汀联合非诺贝特治疗组(辛伐他汀20 mg、每晚1次和非诺贝特200 mg、1次/d,n=30)两组。分别检测两组治疗前及治疗后8周总胆固醇(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?谷丙转氨酶ALT?肌酸激酶CK水平,分别对比两组降脂疗效及安全性。结果治疗前糖尿病合并混合高脂血症两组患者间血脂各项及HbA1c差异无统计学意义,治疗过程中两组患者中均未出现出现ALT及/或CK显著升高。辛伐他汀联合非诺贝特的降脂治疗组TC、TG、LDL-C分别降低32%、39%、31%,HDL-C升高11%。大剂量辛伐他汀治疗组TC、TG、LDL-C分别降低15%、17%、9%,HDL-C升高5%。联合治疗组较大剂量辛伐他汀组TC、TG、LDL-C有显著下降,HDL-C有显著升高。对于经过辛伐他汀20mg、每晚1次治疗至少8周而血脂未达标的糖尿病合并混合高脂血症患者,辛伐他汀联合非诺贝特改善其血脂谱效果优于加大辛伐他汀剂量,且并不增加肝功损伤及横纹肌损伤的副作用。结论联合应用辛伐他汀及非诺贝特较应用更大剂量辛伐他汀降脂治疗能使TC、TG、LDL-C迅速达标且无不良反应发生增多。     

服药疗程对血脂康与辛伐他汀调脂效果的影响

目的 观察服药疗程对血脂康与辛伐他汀调脂效果的影响。方法 将202例不稳定型心绞痛患者随机分为2组,其中辛伐他汀组98例,血脂康组104例。治疗前及治疗3、6个月后,分别检测血清胆固醇(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)含量。按照我国人群血脂分层的合适切点,将各组偏离TC、TG、LDL-C、HDL-C合适切点的病例筛选出来作进一步观察分析。结果 辛伐他汀组和血脂康组服药3个月后即表现出明显的调脂效果,降低TC的有效率分别为40.6％ (28/69)与60.9％ (53/87)、降低LDL-C的有效率分别为51.2％ (33/64)与84.5％ (60/71)、升高HDL-C的有效率分别为22.2％ (4/18)与61.5％ (8/13),血脂康组的有效率明显高于辛伐他汀组,差异均有统计学意义(x2值分别为6.38、17.05和4.04,P＜ 0.05、P＜ 0.01、P＜0.05)。但服药6个月后,2组降TC的有效率分别为89.9％ (62/69)与95.4％(83/87)、降LDL-C的有效率分别为89.1％(57/64)与97.2％ (69/71)、升HDL-C的有效率分别为83.3％ (15/18)与84.6％ (11/13),差异均无统计学意义。辛伐他汀组与血脂康组3个月降TG有效率分别为9.5％(7/74)和24.5％ (24/98);6个月降TG有效率分别为51.4％ (38/74)和68.4％ (67/98);2组比较差异均有统计学意义(x2值分别为6.45和5.13;P均＜0.05)。结论 服药疗程影响血脂康和辛伐他汀调脂效果,血脂康起效更早,特别适合于合并高甘油三酯血症的冠心病患者。     

中剂量洛伐他汀与弹性酶治疗原发性高脂血症研究

目的研究中剂量洛伐他汀对原发性高脂血症的治疗效果。方法按照随机单盲对照法把患者分为2组,在控制饮食的基础上,治疗组61例口服洛伐他汀每晚20mg,对照组口服弹性酶600ag,tid,均8周为1个疗程。结果洛伐他汀组治疗前后血脂(mmol/L)水平自身对比TC、TG、LDL-C、VLDL-C分别从6.86±0.99、2.04±1.04、5.17±1.01、0.46±0.42降至4.61±0.82、1.31±0.63、3.00±0.81及0.27±0.13(均P＜0.001),HDL-C从1.19±0.38升至1.32±0.39(P＜0.05),致粥样硬化指数从4.76降至2.49。弹性酶组,代(mmol/L)从6.15±0.76降至5.77±0.80(P＜0.01),LDL-C(mmol/L)从4.54±0.76降至4.21±0.78(P＜0.05),而对TG、VLDL-C、HDL-C及致粥样硬化指数无明显影响。两组调脂疗效比较洛伐他汀降低TC、TG的总有效率分别为96.7％和75.4％,升高HDL-C总有效率63.9％;而弹性酶降低TC、TG的总有效率均为36.7％,升高HDL-C总有效率为23.3％,两组相比均P＜0.00l。两药对肝、肾功能及血糖无明显影响。结论洛伐他汀每日20mg,剂量适宜,调脂作用理想而全面,疗效可靠,副作用轻微。     

泰脂安胶囊对血脂的调节作用及其对血清氧化低密度脂蛋白的影响

目的 观察泰脂安胶囊的调脂疗效及其对血浆氧化低密度脂蛋白(ox-LDL)水平的影响.方法 观察60例血脂异常患者服用泰脂安胶囊30、60 d后总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)和ox-LDL水平的变化.结果 治疗30、60 d后,患者TC、TG、LDL-C、ox-LDL水平均低于治疗前(P＜0.05),HDL-C水平则升高(P＜0.05).治疗60 d,调节TC、TG、LDL-C和HDL-C水平的总有效率分别为86.7％、90.0％、83.3％及85.0％.结论 泰脂安胶囊可明显改善高脂血症患者血脂代谢障碍,具有降低外周血ox-LDL水平和抗动脉粥样硬化作用.     

甘糖酯治疗原发性高胆固醇血症21例的临床观察

甘糖酯是国内研制的一种新型海洋药物。本文报道甘糖酯对原发性高胆固醇血症患者血清脂蛋白及载脂蛋白的影响。临床资料1.病例选择　1995年7月至1996年12月的门诊与住院患者,经低脂饮食及停用其它任何影响血脂的药物4周后,测定空腹血清总胆固醇(TC)超过6.5mmol/L并排除由糖尿病,甲状腺功能减退,痛风及肝、胆、胰和肾脏等疾病引起的继发性高胆固醇血症。共选择21例患者,男9例,女12例,年龄33～72(51±11)岁。合并症:原发性高血压6例,冠心病3例,脑梗死1例。2.观察方法　1安慰剂期:保持低脂饮食,同时口服与甘糖酯片剂相似的安慰剂100mg,每日3…     

布渣叶配合中药调脂汤治疗血脂异常的临床疗效分析

目的观察布渣叶配合中药调脂汤治疗血脂异常的临床疗效。方法选取2014年10月~2015年10月于本院治疗的血脂异常患者100例作为研究对象,随机分为对照组与观察组,每组各50例,对照组予以单独中药调脂汤(白术、制首乌、杜仲、山楂等),对照组则予以30g布渣叶加入中药调脂汤,60d为一疗程。疗程结束后,比较两组患者总胆固醇(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)、动脉粥样硬化指数(AI)改善情况以及临床疗效。结果两组各项指标较治疗前均有显著改善(P0.05);观察组TG、TC、HDL-C和AI改善情况明显优于对照组(P0.05);观察组总有效率94.0%,显著优于对照组总有效率80.0%(P0.05)。结论布渣叶配合中药调脂汤治疗血脂异常,疗效显著,优于单独运用调脂汤。     

老年高脂血症的调脂治疗观察

目的观察两种降脂药对老年高脂血症的疗效 ,以便临床更好地选择用药。方法病例选择 6 0例确诊为高脂血症的患者。其中男 5 5例 ,女 5例 ,6 0例患者随机分为两组。每组 30例 ,其中 1组服氟伐他汀 (来适可 )胶囊 ,1组服非诺贝特片。 8周后复查血脂和肝肾功能作对照观察。结果治疗后血脂变化 ,来适可组显效 2 3例 (76 .6 7% ) ,有效6例 (2 0 % ) ,总有效率 96 .6 7%。非诺贝特组显效 13例 (43.33% ) ,有效 15例 (5 0 % ) ,总有效率 93.33%。两组比较差异有显著性意义 (P <0 .0 0 1)。在降TC方面来适可组优于非诺贝特组 ,而降TG则非诺贝特组比来适可组要好 ,在升高高密度脂蛋白胆固醇 (HDL C)方面 ,来适可组优于非诺贝特组 ,在降低低密度脂蛋白胆固醇 (LDL C)方面 ,非诺贝特组的效果亦不如来适可组。结论两种降脂药对老年高脂血症都有疗效 ,且副作用较少 ,认为高胆固醇血症选来适可较好 ,而高甘油三酯血症则选非诺贝特合适     

A retrospective meta-analysis of the efficacy and tolerability of fenofibrate 300 mg/d on high-density lipoprotein cholesterol levels in randomized, double-blind, comparative studies conducted in Japan

Background

Low levels of plasma high-density lipoprotein cholesterol (HDL-C) represent an important risk factor for coronary heart disease (CHD). Increasing HDL-C by 1 mg/dL decreases the incidence of CHD by 2% to 3%. Fenofibrate increases HDL-C by ∼23%, to ≥40 mg/dL, and may be effective in preventing CHD.

Objective

The aim of this study was to assess the effects of fenofibrate on HDL-C in patients treated for 12 weeks in 3 randomized, double-blind, comparative studies conducted in Japan. Changes in total cholesterol (TC) and triglycerides (TG), effects on HDL-C and apolipoprotein (apo) A-I and A-II by TG level, and effects on serum lipid levels by type of hyperlipidemia were the secondary end points.

Methods

Changes in HDL-C levels, as well as TC and TG levels, were analyzed in patients who received fenofibrate 300 mg/d for 12 weeks. Patients aged 20 to 80 years with mean TC ≥220 mg/dL (hypercholesterolemia), TG ≥150 mg/dL (hypertriglyceridemia), or both (combined hyperlipidemia) were considered assessable.

Results

In this retrospective meta-analysis conducted at Grelan Pharmaceutical Co. Ltd. (Tokyo, Japan), data from 263 patients (137 women, 126 men; mean [SD] age, 56.0 [10.8] years; range, 25-79 years) were included. The mean (SD) HDL-C level increased significantly, from 46.1 (0.9) mg/dL to 55.9 (1.0) mg/dL after 12 weeks of treatment with fenofibrate (P<0.001). Serum TC and TG decreased significantly (both P<0.001). HDL-C elevation was greater in patients with TG ≥150 mg/dL than in patients with TG<150 mg/dL, although apo A-I and A-II changes were the same in both groups. HDL-C increased in every type of hyperlipidemia, 14.9% in hypercholesterolemia, 22.0% in hypertriglyceridemia, and 33.5% in combined hyperlipidemia. Baseline HDL-C levels were <40 mg/dL in 93 patients (group 1) and ≥40 mg/dL in 170 patients (group 2). Mean HDL-C levels increased significantly in both groups during the treatment period, from 32.6 (0.6) mg/dL to 42.6 (1.0) mg/dL in group 1 and from 53.5 (0.9) mg/dL to 63.1 (1.1) mg/dL in group 2 (both P<0.001). One patient (0.3%) of the 331 included in the tolerability analysis experienced a serious adverse effect (jaundice).

Conclusion

In this study of patients with hypercholesterolemia, hypertriglyceridemia, or combined hyperlipidemia, 12-week treatment with fenofibrate 300 mg/d was effective and generally well tolerated, with the possible exception of transient changes in aminotransferases. HDL-C was increased in all patients to ∼40 mg/dL, the target level.     

瑞舒伐他汀与考来烯胺治疗血脂异常的疗效观察

目的观察瑞舒伐他汀与考来烯胺治疗血脂异常的疗效及安全性。方法80例血脂异常患者随机分为瑞舒伐他汀组40例和考来烯胺组40例,治疗12周。分别测定治疗前后总胆固醇（TC）、三酰甘油（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）等。结果治疗12周后瑞舒伐他汀组TC、LDL—C、TG水平与治疗前比较有明显降低,HDL—C升高,与治疗前比较差异有统计学意义（P〈0．05）。考来烯胺组TC、LDL—C下降,HDL—C增高,与治疗前比较差异有统计学意义（P〈0．05）,TG无明显变化。结论瑞舒伐他汀和考来烯胺均可有效调脂。     

大豆卵磷脂对糖尿病合并高脂血症患者血脂的影响

目的 研究大豆卵磷脂对糖尿病合并高脂血症患者血脂的影响。方法60例糖尿病合并高脂血症患者按血脂水平分为试验组和对照组,每组30例。试验组每13服用大豆卵磷脂20g,对照组服用安慰剂,疗程为6周。分别于服用前后测定血清总胆固醇（TC）、甘油三酯（TG）和高密度脂蛋白胆固醇（HDL—C）的水平。结果服用前试验组与对照组的TC、TG和HDL-C水平差异均无显著性。服用6周后试验组的TC和TG水平显著低于对照组和服用前（P〈0．05）。结论大豆卵磷脂对糖尿病合并高血脂证患者具有降血脂的作用。     

Effects of atorvastatin 10 mg and fenofibrate 200 mg on the low-density lipoprotein profile in dyslipidemic patients: A 12-week, multicenter, randomized, open-label, parallel-group study

Background: Elevated plasma low-density lipoprotein cholesterol (LDL-C) concentrations are highly atherogenic, especially the small, dense LDL (sdLDL) species. Fenofibrate has been reported to shift the LDL profile by decreasing the sdLDL subfraction and increasing larger LDL subclasses. Atorvastatin, anantihyperlipidemic agent, has been reported to reduce plasma total cholesterol (TC) and triglyceride (TG) concentrations and thus could modify the LDL profile.Objective: The aim of this study was to compare the effects of fenofi brate and atorvastatin on standard lipid concentrations and the LDL profile.Methods: In this randomized, open-label, parallel-group study, men and women aged 18 to 79 years with type II primary dyslipidemia, defined as LDL-C ≥160 and TG 150 to 400 mg/dL, after a 4- to 6-week washout period while eating an appropriate diet, were randomized to receive either atorvastatin 10 mg once daily or fenofi-brate 200 mg once daily. Plasma lipid concentrations and cholesterol and apolipoprotein (apo) B (reflecting the LDL particle number) in each LDL subfraction prepared by ultracentrifiigation were determined at baseline and after 12 weeks of treatment. Tolerability was assessed using adverse events (AEs) obtained on laboratory analysis and vital sign measurement. Adherence was assessed by counting unused drug supplies.Results: A total of 165 patients (117 men, 48 women; mean [SD] age, 50.1 [10.7] years; mean TC concentration, 289 mg/dL) were randomized to receive atorvastatin (n = 81) or fenofibrate (n = 84). Compared with fenofibrate, atorvastatin was associated with a significantly greater mean (SD) percentage decrease in TC (27.0% [12.3%] vs 16.5% [12.9%]; P < 0.001), calculated LDL-C (35.4% [15.8%] vs 17.3% [17.2%]; P < 0.001), TC/high-density lipoprotein cholesterol (HDL-C) ratio (29.1% [16.3%] vs 22.9% [15.9%]; P = 0.001), and apoB (30.3% [12.7%] vs 19.6% [15.5%]; P < 0.001). Compared with atorvastatin, fenofibrate was associated with a significantly greater decrease in TG (37.2% [25.9%] vs 20.2% [27.3%]; P < 0.001) and a significantly greater increase in HDL-C concentration (10.4% [15.7%] vs 4.6% [12.1%]; P = 0.017). Fibrinogen concentration was significantly different between the 2 groups (P = 0.002); it was decreased with fenofibrate use (4.6% [23.7%]) and was increased with atorvastatin use (5.7% [23.5%]). Atorvastatin did not markedly affect the LDL distribution; it was associated with a homogeneous decrease in cholesterol and apoB concentrations in all subfractions, whereas fenofibrate was associated with a marked movement toward a normalized LDL profile, shifting the sdLDL subfractions toward larger and less atherogenic particles, particularly in those patients with baseline TG ≥200 mg/dL. No serious AEs related to the study treatments were reported. A total of 5 AEs were observed in 8 patients, including: abdominal pain, 3 patients (2 in the atorvastatin group and 1 in the fenofibrate group); abnormal liver function test results, 1 (fenofibrate); increased creatine Phosphokinase activity, 2 (atorvastatin); gastrointestinal disorders, 1 (fenofibrate); and vertigo, 1 (fenofibrate).Conclusion: In these dyslipidemic patients, fenofibrate treatment was associated with an improved LDL subfraction profile beyond reduction in LDL-C, particularly in patients with elevated TG concentration, whereas atorvastatin was associated with equally reduced concentrations of cholesterol and apoB in all LDL subfractions independent of TG concentrations.     

Fluvastatin/fenofibrate vs. simvastatin/ezetimibe in patients with metabolic syndrome: different effects on LDL-profiles

Background  Patients with metabolic syndrome (MS) and type 2 diabetes (T2DM) show increased risk for coronary artery disease. Lipoprotein metabolism is characterized by elevated triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C) and predominance of atherogenic small, dense low-density lipoprotein (sdLDL), while low-density lipoprotein (LDL) cholesterol is only slightly elevated.
Methods  Multicentre, randomized, open-label cross-over study investigating the effect of combination of fluvastatin/fenofibrate (80/200 mg) (F&F) on LDL-subfractions compared with combination of simvastatin/ezetimibe (20/10 mg) (S&E) in patients with MS/T2DM.
Results  Seventy-five patients were randomized, 69 completed the study and LDL-subfractions of 56 patients were analysed. Thirty-eight out of 56 patients (68%) showed a profile dominated by sdLDL. In these, TG and total cholesterol (TC) were elevated compared with non-sdLDL patients. In all patients, reduction of TC and LDL cholesterol (LDL-C) by S&E was stronger than by F&F. The increase of HDL-C was stronger with S&E in the non-sdLDL group, whereas in the sdLDL group, there was no difference between treatments. In non-sdLDL patients, there was no effect on TG or LDL-radius. However, in the sdLDL group, F&F was more effective in reducing TG and increased LDL radius, whereas S&E reduced LDL radius even further.
Conclusions  S&E is more efficient in reducing TC and LDL-C. This is also true for HDL-C increase in non-sdLDL patients. However, in patients with sdLDL, F&F was more efficient in reducing TG and increasing LDL radius.     

益气活血解毒汤对动脉粥样硬化患者血脂、细胞间粘附分子-1、C反应蛋白的影响

目的观察益气活血解毒汤对动脉粥样硬化患者血脂、细胞间粘附分子-1(ICAM-1)、C反应蛋白(CRP)的影响,探讨其抗动脉粥样硬化的机制。方法将动脉粥样硬化患者随机分为两组,对照组20例,采用常规西药治疗,治疗组20例,在对照组治疗的基础上加服益气活血解毒汤,疗程共为3周,在治疗前后分别测定两组血清三酰甘油(TG)、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)、细胞间粘附分子-1(ICAM-1)及C反应蛋白(CRP)的含量。结果对照组治疗前后TG、TC、LDL-C、HDL-C、ICAM-1及CRP的数值变化无意义,治疗组治疗前后TC、LDL-C、HDL-C、ICAM-1及CRP的数值变化有意义,治疗组与对照组比较,在降低TC、LDL-C、CRP、ICAM-1和升高HDL-C方面有意义。结论益气活血解毒汤对动脉粥样硬化有明显预防和治疗作用,调脂、抑制粘附分子的表达可能为其机制之一。     

Comparison of fluvastatin + fenofibrate combination therapy and fluvastatin monotherapy in the treatment of combined hyperlipidemia, type 2 diabetes mellitus, and coronary heart disease: a 12-month, randomized, double-blind, controlled trial

BACKGROUND: Diabetes risk is often complicated by a mixed hyperlipoproteinemia not sufficiently controlled by a single antihyperlipidemic drug; however, there are some concerns about the safety of combined statin and fibrate treatments. OBJECTIVE: The aim of this study was to compare the efficacy and safety profile of fluvastatin + fenofibrate combination therapy and those of fluvastatin monotherapy in the treatment of combined hyperlipidemia, type 2 diabetes mellitus (DM), and coronary heart disease (CHD) (ie, high risk for cardiovascular disease [CVD]). METHODS: This 12-month, randomized, double-blind, controlled trial was conducted at the University of Pavia, Pavia, Italy. Patients aged 18 to 80 years with combined hyperlipidemia, type 2 DM, and CHD were randomly assigned to receive combination therapy with extended-release fluvastatin 80 mg + micronized fenofibrate 200 mg or monotherapy with extended-release fluvastatin 80 mg. All treatments were given in tablet form, once daily with the evening meal, for 12 months. Lipid variables (low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol [TC], and triglycerides [TG]) at 6 and 12 months were the primary efficacy variables, and glycemic status (glycosylated hemoglobin [HbA(1c)], fasting plasma glucose, and postprandial plasma glucose levels) at 6 and 12 months was the secondary efficacy variable. Tolerability was assessed using physical examination, including vital-sign assessment, body-weight measurement, electrocardiography, adverse events, and laboratory tests. A pharmacoeconomic analysis of both treatment regimens was also carried out using the incremental cost-effectiveness ratio (ICER). RESULTS: A total of 48 patients (24 men, 24 women; mean [SD] age, 60 [5] years) were enrolled. After 6 months, all primary efficacy variables, except for TG level, showed significant improvements from baseline only in the combination-therapy group (changes: LDL-C, -25%; HDL-C, +12%; and TC, -19%; all, P < 0.05 vs baseline). After 12 months, lipid variables showed significant improvements over baseline in both groups (all, P < 0.05), except for TG in the monotherapy group. Significant changes in LDL-C, HDL-C, and TG were found in the combination-therapy group (-35%, +34%, -32%, respectively) versus the monotherapy group (-25%, +14%, -17%, respectively; all, P < 0.05 between groups). The change from baseline in HbA(1c) level was significant with combination therapy (-12% vs -7%; P < 0.05). Both treatments were well tolerated, with no significant differences in the incidences of adverse events between the 2 groups. The ICER showed that each 1% decrease in LDL-C level achieved with the fenofibrate + fluvastatin combination added a cost of 14.97 Euros/y (US 12.25 US dollars/y), and each 1% increase in HDL-C level added a cost of 7.48 Euros/y (6.12/y US dollars), over the cost of monotherapy. CONCLUSIONS: In this selected sample of patients with combined hyperlipidemia, type 2 DM, and CHD, the combination of extended-release fluvastatin + micronized fenofibrate was associated with a more improved lipid profile than fluvastatin monotherapy, and was a well-tolerated and cost-effective therapeutic choice to treat these patients at high risk for CVD.     

辛伐他汀对2型糖尿病高脂血症的疗效

目的:探讨辛伐他汀 20mg/d治疗 2型糖尿病高脂血症的疗效及安全性。方法:60例 2型糖尿病高脂血症患者随机分为2组,各30例。分别予辛伐他汀1片(每片 5mg或20mg)·qn,用药4wk。结果:辛伐他汀20mg/d组降低TC 33％,降低LDL-C 46％,降低TG 26％,升高 HDL-C21％,且降低TC/HDL-C 44％。组间比较,2组的血清TG、LDL-C降低幅度及 HDL-C上升幅度有显著性差异(P<0.01)TC 降低幅度无明显差异(P>0.05)。对血糖水平无不良影响。结论:20mg/d治疗2型糖尿病高脂血症患者安全、有效。     

Efficacy and tolerability of a "suprabioavailable" formulation of fenofibrate in patients with dyslipidemia: a pooled analysis of two open-label trials

BACKGROUND: Newer fibrates such as micronized fenofibrate lower triglyceride (TG) levels, raise high-density lipoprotein cholesterol (HDL-C) levels, and lower fibrinogen levels, in addition to markedly lowering levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C). A new microcoated "suprabioavailable" formulation of fenofibrate has demonstrated a superior pharmacokinetic profile compared with micronized fenofibrate 200 mg/d and may effectively reduce cardiovascular risk factors at the lower dose of 160 mg/d. OBJECTIVE: The goal of this study was to assess the efficacy and tolerability of the suprabioavailable" formulation of fenofibrate in patients with type IIa, type IIb, or type IV dyslipidemia. METHODS: This was a pooled analysis of data from 2 unpublished multicenter, open-label trials with a common protocol. After a 4-week washout period, patients with dyslipidemias not corrected by diet alone were assigned to receive microcoated fenofibrate 160 mg/d for 12 weeks. Changes in lipid profiles and safety variables (vital signs, body weight, and laboratory measures) were monitored throughout the study, and adverse events occurring between visits 1 and 5 were recorded by the study investigators. RESULTS: The 2 trials included 375 men and women (mean age, 55.2 years) with type IIa (n = 158), type IIb (n = 195), type IV (n = 21), or other (n = 1) dyslipidemias. At end point. HDL-C levels in patients with type IIa, IIb, or IV dyslipidemia were increased by a respective 10.9% (P < 0.001), 16.1% (P < 0.001), and 12.1% (P < 0.05), whereas TG levels were decreased by a respective 27.7% (P < 0.001), 46.4% (P < 0.001), and 40.2% (P < 0.05). In patients with type IIa or IIb dyslipidemia, TC decreased (-14.3% in each group), LDL-C decreased (-20.6% and -13.2%, respectively), and the LDL-C/HDL-C ratio decreased (-26.7% and -22.0%) (all, P < 0.001). Overall, 121 of 375 (32.3%) patients experienced > or = adverse event (AE) (202 nonserious, 8 serious). Of these, 10.1% were judged to be possibly drug related. The most common nonserious AEs were those affecting the body as a whole (2.7% of patients) and the digestive system (5.3% of patients). No serious AE was considered drug related. CONCLUSIONS: The new "suprabioavailable" microcoated, micronized formulation of fenofibrate appears to maintain the good efficacy and safety profile of micronized fenofibrate. In the study population with moderate dyslipidemia (types IIa and IIb), it promoted beneficial changes in major lipid risk factors for cardiovascular disease.     

中老年人餐后高甘油三酯血症的临床干预

目的了解噻唑烷二酮类药物马来酸罗格列酮对餐后高甘油三酯(TG)血症中老年患者的疗效。方法采用改良脂肪餐负荷试验,以餐后4 h血清TG水平(TG 4 h)>2 mmol/L确定为餐后高TG血症患者39例,随机分为非诺贝特组12例(口服微粒化非诺贝特200 mg,每晚1次顿服,共8周),罗格列酮组27例(口服马来酸罗格列酮4 mg,每天1次晨服,共8周),两组于治疗前、治疗后4周和8周进行脂肪餐负荷试验,同时测定空腹血糖(FPG)和空腹胰岛素(FIns),以胰岛素敏感指数(ISI)作为胰岛素敏感性判断指标,进行对比分析。结果在不同时段两组内脂肪餐负荷试验前后比较,TG4h水平较同组餐前空腹TG水平比较升高(P<0.05),而脂肪餐后HDL-C水平较同组餐前空腹HDL-C水平明显下降(P<0.05),TC、LDL-C均未见明显变化;非诺贝特组治疗8周后,空腹TG、TG4h均呈明显下降(P<0.05),HDL-C、餐后4h HDL-C呈明显升高(P<0.05);罗格列酮组治疗8周后,空腹TG、TG4h、ISI绝对值均呈明显下降(P<0.05),HDL-C、餐后4hHDL-C呈明显升高(P<0.05)。结论短期应用马来酸罗格列酮不仅可以改善胰岛素敏感性,还可以有效地降低餐后高TG血症患者的餐后TG水平,升高HDL-C水平。