复方缬沙坦治疗轻中度原发性高血压患者的疗效观察

目的评价复方缬沙坦（缬沙坦80mg／氢氯噻嗪12．5mg复方制剂）治疗经单用缬沙坦80mg控制不良的轻、中度原发性高血压患者疗效和安全性。方法采用多中心、双盲、双模拟、随机、活性药物对照、平行试验方法。对经2周洗脱期的轻、中度原发性高血压患者[坐位舒张压≥95mmHg（1mmHg=0．133kPa）且〈110mmHg]采用单药缬沙坦80mg／d治疗4周,在单药导入结束后,坐位舒张压仍〉190mmHg的864例患者按1：1随机、双盲分为复方缬沙坦组或缬沙坦80mg／d组,继续治疗8周。在治疗4周和结束时评估药物安全性及有效性。结果在轻、中度原发性高血压患者中复方缬沙坦每日1次比单用缬沙坦80mg／d血压进一步下降、达标率提高。治疗结束时平均坐位收缩压多降低3．5mmHg,平均坐位舒张压多下降2．2mmHg,血压控制〈140／90mmHg的患者在复方缬沙坦组和单用缬沙坦80mg／d组分别为53．9％及40．9％。结论轻、中度原发性高血压患者采用复方缬沙坦治疗组降压有效率及达标率均优于每日1次服用缬沙坦80mg／d组。复方缬沙坦适用于缬沙坦单药控制不良的轻、中度原发性高血压患者。     

缬沙坦/氨氯地平复方片剂对单药控制不良的轻中度高血压患者的疗效观察

目的 评价缬沙坦(80 mg)/氨氯地平(5 mg)复方片剂(复方片剂)治疗经氨氯地平5 mg或缬沙坦80 mg控制不良的轻、中度原发性高血压患者疗效和安全性.方法 采用多中心、双盲、双模拟、随机、活性药物对照、平行试验方法进行两项临床研究.在两项研究中对经1～4周洗脱期的轻、中度原发性高血压患者[坐位舒张压≥95 mm Hg(1 mm Hg=0.133 kPa)且<110 mm Hg]分别采用单药氨氯地平5 mg或缬沙坦80 mg治疗4周,在单药导入结束后,坐位舒张压仍然≥90mm Hg且<110 mm Hg的患者随机进入复方片剂组或继续原有的单药治疗,共8周.其间,在治疗4周和试验结束时评估药物的安全性及有效性.结果 治疗结束时,复方片剂组平均坐位收缩压/平均坐位舒张压下降幅度较氨氯地平单药治疗组多4.4mm Hg/3 mm Hg(P<0.0001);较缬沙坦80 mg组多6.4 mm Hg/4.2 mm Hg(P<0.0001).两项研究中复方片剂组的血压控制率(血压<140/90 mmHg)分别为71.0%及71.2%,显著优于氨氯地平或缬沙坦单药治疗组,不良事件发生率与单药治疗组相当.结论 复方片剂组的血压控制率显著优于其两种成分(氨氯地平5 mg或缬沙坦80 mg)单药的治疗,且具有良好的安全性和耐受性.     

瑞舒伐他汀钙与阿托伐他汀钙治疗高脂血症合并高血压的效果分析

目的分析瑞舒伐他汀钙与阿托伐他汀钙治疗高脂血症合并高血压的效果。方法将我院2011年5月-2012年5月收治的60例高脂血症合并高血压的患者随机分为对照组和观察组,每组30例。两组患者在口服5mg/d的氨氯地平控制血压后,观察组高脂血症合并高血压患者服用瑞舒伐他汀钙,对照组高脂血症合并高血压患者服用阿托伐他汀钙,药量均为10mg/d。结果经过治疗后,对照组高脂血症合并高血压患者的总有效率仅为63.33%,观察组高脂血症合并高血压患者的总有效率可以达到86.67%(P0.05)。结论瑞舒伐他汀钙可以更好地改善高脂血症合并高血压患者的高血脂和高血压状况,治疗效果优于阿托伐他汀钙,值得在临床上推广应用。     

复方非洛地平缓释片治疗轻中度原发性高血压患者的有效性及安全性随机双盲临床试验

目的评价复方非洛地平缓释片治疗轻、中度原发性高血压患者的疗效和安全性。方法采用随机、双盲双模拟、阳性药物平行对照方法,从轻中度原发性高血压病人367例筛选出232例(对照组115例,试验组117例),随机进入8周的治疗期。试验组口服复方非洛地平缓释片(马来酸依那普利5mg+非洛地平2.5mg复方制剂)1片/d和非洛地平缓释片模拟剂2片/d,对照组口服非洛地平缓释片(非洛地平2.5mg/片,2片/d)和复方非洛地平缓释模拟剂片(1片/d)。治疗4周后舒张压≥90mmHg者剂量加倍。最终完成试验并符合试验要求的病例共220例(对照组111例,试验组109例)。结果对照组和试验组治疗8周后的坐位血压舒张压变化值(主要疗效指标)分别为(-9.3±7.7)和(-9.0±8.3)mmHg,与基线比较,差异有统计学意义(均P<0.01);但组间比较,差异无统计学意义(P=0.81)。次要疗效指标:对照组和试验组治疗4周后收缩压变化值分别为(-7.8±8.9)和(-8.1±9.3)mmHg,舒张压变化值为(-6.0±5.7)和(-5.7±6.4)mmHg,治疗8周后收缩压变化值分别为(-12.3±11.5)和(-11.7±12.9)mmHg,两组血压与基线比较,差异有统计学意义(均P<0.01),但组间比较,差异无统计学意义(P值分别为0.67、0.82及0.96)。治疗4周和治疗8周后,对照组血压达标率为20.9%和53.9%,试验组血压达标率为16.2%和48.7%,两组之间差异无统计学意义(P值分别为0.37和0.41)。对照组和试验组的不良反应发生率分别为5.2%和10.3%(P=0.22),主要为转氨酶升高和咳嗽。对照组和试验组重要不良事件的发生率分别为4.3%及6.8%(P=0.57)。结论复方非洛地平缓释片治疗轻中度原发性高血压安全、有效。     

复方缬沙坦与血脂康联合治疗原发性高血压的临床研究

目的评价复方缬沙坦(缬沙坦80mg/氢氯噻嗪12.5mg)联合血脂康(600mg)治疗轻、中度原发性高血压患者的疗效和安全性。方法采用随机、双盲对照研究。将280例轻、中度高血压患者随机分为缬沙坦组和对照组。缬沙坦组患者给予复方缬沙坦(缬沙坦80mg/氢氯噻嗪12.5mg,1次/d)和血脂康(600mg,2次/d)治疗,对照组患者降压药物单用缬沙坦(80mg,1次/d)。治疗中每周测量血压。在治疗8周和结束时评价药物安全性和有效性。结果对于轻、中度原发性高血压患者,缬沙坦组较对照组血压进一步下降,达标率显著高于对照组。治疗结束时平均坐位收缩压均降低5mmHg,平均坐位舒张压多下降3mmHg,缬沙坦组和对照组患者中,血压控制<140/90mmHg者分别占54.1%和40.7%。结论轻、中度原发性高血压患者采用复方缬沙坦联合血脂康治疗,降压效果和达标率均优于单用缬沙坦。     

氨氯地平联用小檗碱治疗老年轻中度高血压合并痛风的临床疗效分析

目的评价氨氯地平联用小檗碱治疗轻中度老年高血压合并痛风患者的降压疗效。方法选择轻中度老年高血压患者26例,患者口服氨氯地平5 mg,1次/日,小檗碱0.3 g,3次/日,急性痛风患者,口服秋水仙碱0.5 mg,慢性痛风患者,口服别嘌呤醇100 mg。观察患者服药前后血压、血脂指标的变化。结果治疗8周后,舒张压、收缩压分别从(104±5)mmHg、(166±8)mmHg下降至(83±3)mmHg、(131±7)mmHg;治疗前后差异有统计学意义(P<0.05)。治疗后血脂指标较治疗前明显改善(P<0.05)。结论氨氯地平联用小檗碱治疗轻、中度老年高血压合并痛风患者,在短期内可有效降低血压。     

硝苯地平与左旋氨氯地平治疗原发性高血压临床疗效的对比研究

目的对比硝苯地平与左旋氨氯地平治疗原发性高血压的临床疗效。方法选取我院2011年5月—2013年5月收治的原发性高血压患者64例,随机分为硝苯地平组和左旋氨氯地平组,每组32例。硝苯地平组患者给予硝苯地平片口服,20 mg/次,1次/d;左旋氨氯地平组患者给予左旋氨氯地平片口服,5 mg/次,1次/d。两组患者均连续治疗6周。每周定期评定两组患者临床疗效,观察两组患者治疗前、治疗6周后日间血压及治疗6周后夜间血压,记录两组患者治疗期间不良反应情况。结果两组患者治疗第1周总有效率比较,差异无统计学意义(P0.05);治疗第2、3、4、5、6周,左旋氨氯地平组患者总有效率均高于硝苯地平组(P0.05)。两组患者治疗前日间收缩压、日间舒张压比较,差异均无统计学意义(P0.05);治疗6周后左旋氨氯地平组日间收缩压、日间舒张压、夜间收缩压、夜间舒张压均低于硝苯地平组(P0.05)。治疗期间左旋氨氯地平组患者不良反应发生率为6.3%,低于硝苯地平组的12.5%(P0.05)。结论左旋氨氯地平治疗原发性高血压的临床疗效优于硝苯地平,其夜间血压控制效果更为理想,且不良反应较少,值得临床推广应用。     

左旋氨氯地平治疗高血压合并心绞痛的疗效分析

目的　观察左旋氨氯地平对心绞痛合并轻、中度高血压患者的疗效。方法　 1 0 6例心绞痛合并轻、中度高血压患者随机分为对照组 :氨氯地平 5mg、一日一次 ;治疗组 :左旋氨氯地平 2 5mg、一日一次 ,疗程8周。结果　两药有明显相同且疗效稳定的抗心绞痛和降血压作用 ,而左旋氨氯地平副作用略低于氨氯地平。结论　左旋氨氯地平不仅有良好的降血压作用 ,同时可以抗心绞痛及心肌缺血。     

苯磺酸左旋氨氯地平片治疗原发性高血压40例

目的观察苯磺酸左旋氨氯地平片治疗原发性高血压的临床疗效。方法 40例高血压患者给予苯磺酸左旋氨氯地平2.5 mg/d,每天晨起口服,治疗1周疗效不满意者,剂量增加至5 mg/d,服药4周。结果治疗后,收缩压和舒张压均较治疗前降低(P<0.05),1级、2级、3级高血压有效率分别为100.0%、90.9%和50.0%。血尿常规及电解质、血糖、尿素氮、肌酐、血脂、肝功能和血液流变学指标治疗前后无异常变化。结论苯磺酸左旋氨氯地平是治疗原发性高血压的一种有效、安全、依从性好的药物。     

缬沙坦在老年高血压患者治疗中的应用

目的 评价缬沙坦治疗轻、中度老年原发性高血压的临床疗效及安全性.方法 将160例轻、中度老年原发性高血压患者随机分为试验组与对照组.试验组用缬沙坦80～160 mg/d治疗,对照组用贝那普利10～20 mg/d治疗,治疗时间为12周.结果 两组的总有效率分别为81.2％和82.9％,降压幅度分别为33/20 mm Hg和31/22 mm Hg,两组间比较差异无统计学意义（P＞0.05）.两组左心室心肌肥厚均较明显改善（P＜0.05）,但两组间比较差异无统计学意义（P＞0.05）.不良反应两组均较轻,但试验组明显少于对照组（P＜0.05）.结论 缬沙坦治疗轻、中度老年原发性高血压疗效好、安全性高,可作为轻、中度老年原发性高血压患者降压首选药物之一.     

Efficacy and safety of coadministered amlodipine and atorvastatin in patients with hypertension and dyslipidemia: results of the AVALON trial

The AVALON study was a randomized, multicenter trial to assess the efficacy and safety of coadministered amlodipine and atorvastatin in patients with hypertension and dyslipidemia. Phase one was an 8-week, double-blind, double-dummy, placebo-controlled period whereby patients received amlodipine 5 mg, atorvastatin 10 mg, amlodipine 5 mg and atorvastatin 10 mg, or placebo. Thereafter, all patients received single-blind amlodipine 5 mg and atorvastatin 10 mg for 8-weeks, followed by 12 weeks of open-label treatment where doses could be titrated to improve low-density lipoprotein cholesterol and blood pressure control. A total of 847 patients entered the double-blind phase. At Week 8, 45% of the patients receiving amlodipine 5 mg and atorvastatin 10 mg reached both their blood pressure and low-density lipoprotein cholesterol goals, compared with 8.3% with amlodipine (p < 0.001), 28.6% with atorvastatin (p < 0.001), and 3.5% with placebo. At 28 weeks, 67.1% of patients coadministered amlodipine and atorvastatin (mean doses, 7.6 mg and 28.4 mg, respectively) achieved both targets. Framingham estimated 10-year risk of coronary heart disease declined from baseline levels of 15.1% to 6.9% at Week 28. Following coadministered treatment, the adverse events reported were similar to either agent alone. Concomitant administration of amlodipine and atorvastatin is an effective and well tolerated treatment for coexisting hypertension and dyslipidemia.     

氨氯地平和坎地沙坦联用对原发性高血压尿微量清蛋白的影响

目的 评价联合应用钙拮抗剂(氨氯地平)和血管紧张素Ⅱ受体拮抗剂(坎地沙坦)及单用对原发性高血压患者血压及尿微量清蛋白(MAU)的影响.方法 高血压1、2级伴MAU阳性门诊患者90例,随机分为联合用药组(氨氯地平5mg/d+坎地沙坦8mg/d,n=30)、单用氨氯地平组(5mg/d,n=30)和单用坎地沙坦组(8mg/d,n=30).治疗2周后单用组血压未达标者剂量加倍以达目标血压,疗程共6个月.记录治疗前、治疗后3个月和6个月血压、MAU的变化及可能发生的不良事件.结果 治疗3个月后3组血压均较治疗前明显下降(P＜0.01),且联合组较坎地沙坦组降压更明显(P＜0.01),与氨氯地平组无明显差异,治疗6个月后联合组较氨氯地平组显示降压更有效(P＜0.05);3组治疗3个月后MAU均较治疗前明显减少(P＜0.01),且随时间延长作用更明显.两个单用组与联合用药组比较,坎地沙坦组优于氨氯地平组(P＜0.01),联合组优于坎地沙坦组(P＜0.05).结论 钙拮抗剂类药物和血管紧张素Ⅱ受体拮抗剂联用较单一药物剂量加倍对血压控制情况有明显优势,且能更好改善高血压患者的早期肾损害,提示早期肾损害者应尽早联合降压治疗.     

Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14,236 patients

Atorvastatin has been shown to reduce coronary events and revascularization procedures in patients with multiple risk factors for coronary heart disease. Recent studies with atorvastatin 80 mg support the overall safety of this dose during long-term treatment. However, physicians appear reluctant to use high doses of statins. A retrospective analysis of pooled data from 49 clinical trials of atorvastatin in 14,236 patients treated for an average period of 2 weeks to 52 months was conducted. The study compared the safety of atorvastatin 10 mg (n = 7,258), atorvastatin 80 mg (n = 4,798), and placebo (n = 2,180) and included analyses on treatment-associated adverse events; nonserious and serious adverse events related to the musculoskeletal, hepatic, and renal systems; the incidence of elevations of creatine kinase >10 times the upper limit of normal (ULN); and hepatic transaminases >3 times ULN. Percentages of patients experiencing > or =1 adverse event were similar across all 3 groups. Withdrawals due to treatment-related adverse events were observed in 2.4%, 1.8%, and 1.2% of patients in the atorvastatin 10 mg, atorvastatin 80 mg, and placebo groups, respectively. Serious adverse events were rare and seldom led to treatment withdrawal with any dose. Treatment-associated myalgia was observed in 1.4%, 1.5%, and 0.7% of patients in the atorvastatin 10 mg, atorvastatin 80 mg, and placebo groups, respectively. No cases of rhabdomyolysis were reported in any group. Persistent elevations in hepatic transaminases >3 times ULN were observed in 0.1%, 0.6%, and 0.2% of patients in the atorvastatin 10 mg, atorvastatin 80 mg, and placebo groups, respectively. The incidence of treatment-associated adverse events for atorvastatin 80 mg was similar to that of atorvastatin 10 mg and placebo. In conclusion, the results of this analysis support the positive safety profile of atorvastatin at the highest dose.     

氨氯地平阿托伐他汀钙片治疗高血压合并冠心病的临床观察

目的探讨氨氯地平阿托伐他汀钙片应用于高血压合并冠心病的临床疗效。方法以我院2011年7月-2014年3月我院就诊确诊的86例高血压合并冠心病患者为研究对象,按随机数字法随机分为观察组与治疗组,其中治疗组43例,对照组43例;治疗组给予氨氯地平阿托伐他汀片治疗,而对照组采用硝苯地平片治疗,比较两组患者临床治疗效果。结果两组患者进行治疗后,两组患者血压下降,心绞痛症状改善,症状改善总有效率观察组显著高于对照组(P0.05);在观察组LDL-C、TC两项治疗后与治疗前比较显著下降,有统计学差异(P0.05),两组患者均无严重不良事件发生。结论氨氯地平阿托伐他汀片治疗高血压合并冠心病患者具有良好的降压效果,改善冠心病症状,有效降低血脂,临床疗效确切,并且方便依从性高。     

国产苯磺酸氨氯地平降压效果及安全性的多中心随机临床对照研究

目的　比较国产苯磺酸氨氯地平 (安内真 ) 5mg与进口苯磺酸氨氯地平 (络活喜 ) 5mg每天一次口服治疗原发性轻、中度高血压的有效性和安全性。方法　多中心、随机平行对照研究 ,98例轻、中度高血压患者被随机分入安内真组和络活喜组 ,分别每天一次口服安内真 5mg或络活喜 5mg ,2周后如坐位舒张压 >90mmHg或坐位收缩压 >14 0mmHg ,则改为安内真 10mg或络活喜 10mg、每天一次口服。结果　服药 2 ,4周时 ,安内真与络活喜两组平均舒张压和收缩压均明显下降 ,两组比较无明显差异 ;治疗 4周时两组控制血压的总有效率分别为 75 56% ,77 0 8% ,两组间无明显差异 ;不良反应事件发生率低 ,两组相似。结论　国产苯磺酸氨氯地平 (安内真 ) 5mg或 10mg每日一次治疗原发性轻、中度高血压安全有效 ,其疗效与进口苯磺酸氨氯地平 (络活喜 )等同     

氨氯地平/阿托伐他汀治疗高血压合并高脂血症的疗效观察

目的 前瞻性评估氨氯地平/阿托伐他汀(多达一)治疗原发性高血压合并高脂血症的疗效和安全性.方法 102 例轻、中度原发性高血压合并高脂血症患者服用多达一1～2 片,共12 周.服药前、后行动态血压监测(ABPM),颈动脉内膜厚度和血脂测定,观察降压效果、不良反应、颈动脉内膜厚度和血脂的变化.结果 多达一能有效降低血压,12 周治疗的有效率为74%.颈动脉粥样斑块平均厚度由(2.03±0.25)mm下降为(1.57±0.21)mm,下降幅度为23%;TC 由(6.19±0.40)mmol/L 下降为(4.39±0.37)mmol/L,下降幅度为29%;LDL-C 由(4.19±0.35)mmol/L 下降为(2.98±0.31)mmol/L,下降幅度为24%;HDL-C 由(1.04±0.23)mmol/L 上升为(1.28±0.26)mmol/L,上升幅度为18%(P＜0.01).多达一不良反应发生率低.结论 多达一能有效控制血压和降低胆固醇,是强化抗动脉粥样硬化的降压药,能提供更多心脑血管保护.     

贝那普利/氨氯地平复方制剂与贝那普利单药治疗轻中度高血压的多中心随机双盲平行对照研究

目的 评价贝那普利/氨氯地平复方片剂与贝那普利片单药治疗轻、中度高血压患者的有效性和安全性.方法 本研究为多中心、随机、双盲、平行对照研究.356例原发性高血压患者经2周洗脱期后,再给予4周贝那普利片10 mg单药治疗,220例平均坐位舒张压(SeDBP)仍≥90 mm Hg(1 mm Hg=0.133 kPa)的患者随机分为贝那普利(10 mg)/氨氯地平(5 mg)固定剂量复方片剂组(复方制剂组,1片/d,n=113)和贝那普利片单药组(单药治疗组,20 mg/d,n=107),治疗4周末两组诊室SeDBP≥90 mmHg者剂量加倍.SeDBP＜90 mm Hg者续服原剂量,共随机双盲治疗8周.以总有效率和SeDBP下降差值作为主要疗效指标.其中74例患者(复方片剂组38例,单药组36例)完成了24 h动态血压监测,并作为降压疗效的评价指标.结果 随机、双盲治疗8周末,复方片剂组SeDBP下降值为(11.7±6.8)mm Hg、达目的 血压占65.7%、总有效率为88.5%;单药治疗组SeDBP下降值为(7.7±6.9)mm Hg、达目的 血压占35.5%、总有效率为65.5%.两组组间比较差异均有统计学意义(P＜0.001).24 h动态血压监测结果,复方制剂组和单药组的舒张压/收缩压(DBP/SBP)的谷/峰比率(T/P)分别为83.1%/76.0%和85.8%/79.5%(P＜0.05).复方制剂组与单药治疗组的不良反应发生率分别为16.8%和35.5%(P＜0.01).结论 贝那普利/氨氯地平复方制剂治疗原发性高血压患者的降压疗效明显优于贝那普利单药治疗,且有良好的耐受性.

Abstract：

Objective To evaluate the efficacy and tolerability of the fixed combination of amlodipine 5 mg/benazepril 10 mg once-daily therapy, compared with benazepril, 10 mg, monotherapy in patients with mild and moderate hypertension, and to evaluate the 24 h antihypertensive efficacy and the duration of action by ambulatory blood pressure monitoring Methods In a multicenter, randomized,double-blind, parallel controlled trial, 356 cases of hypertensive patients after 2 weeks wash-out, and then given 4 weeks of benazepril 10 mg monotherapy, 220 patients with mean seated diastolic blood pressure (SeDBP)remained ≥90 mm Hg(1 mm Hg = 0. 133 kPa)were randomly divided into benazepril 10 mg/amlodipine 5 mg(BZ10/AML5)fixed-dose combination therapy group(once a day, n = 113), and benazepril monotherapy group(daily 20 mg, n = 107). In the two groups the patients with SeDBP≥90 mm Hg were doubled the dosage of the initial regimen at the end of 4-week treatment for additional 4 weeks , and the patients with SeDBP ＜ 90 mm Hg remained the initial regimen for additional 4 weeks. The primary endpoint was to evaluate the improvement of SeDBP at the end of 8-week treatment. There were 74 patients(the combination therapy group n = 38, monotherapy therapy group n = 36)completed the 24 h ambulatory blood pressure monitoring which was included in the final efficacy analysis. Results The randomized, doubleblind treatment for 8 weeks, the mean value of SeDBP reduction, the reaching target blood pressure rate and total successful response rate to the treatment(a SeDBP ＜ 90 mm Hg or a decrease of 10 mm Hg or more from baseline)were(11.7 ± 6.8)mm Hg, 65.7% and 88.5% in the combination therapy group,respectively, and were(7.7 ±6. 9)mm Hg, 35.5% and 65.5% in the monotherapy group, respectively.There were statistically significant difference between the combination therapy and the monotherapy groups in all the 3 indexs(P ＜ 0. 001). The fixed combination significantly reduced systolic blood pressure(SBP)and diastolic blood pressure(DBP)values throughout the 24 h. The trough to peak ratios of DBP/SBP in the fixed compound of benazepril/amlodipine(10 mg/5 mg)and benazepril(20 mg)alone were 83. 1%/76. 0% and 85.8%/79. 5%, respectively. Adverse events rates were 16. 8% in the combination therapy group and 35.5% in the monotherapy group(P ＜ 0. 001). Conclusions The combination therapy with benazepril/amlodipine was superior to benazepril monotherapy and was well tolerated in patients with essential hypertension and allowing a satisfactory BP control for 24 hours.     

A randomized, double-blind, placebo-controlled, 8-week study to evaluate the efficacy and safety of once daily atorvastatin (10 mg) in patients with elevated LDL-cholesterol

Lowering of serum cholesterol levels by pharmacologic intervention with statins reduces the incidence of cardiovascular events in subjects with and without atherosclerotic manifestations. In an 8-week, randomized, double-blind study we compared the efficacy and safety of the new compound atorvastatin for reducing LDL-cholesterol (LDL-C) with placebo in an Asian patient cohort. Patients with LDL-C between 160 mg/dl and 250 mg/dl were randomly assigned to treatment with 10 mg atorvastatin or placebo once daily for 8 weeks. At the end of weeks 4 and 8 of the randomized phase, the serum concentrations of lipid parameters as well as safety parameters were determined. Fifty-four patients (32 males and 22 females) were enrolled. Twenty-six patients were assigned to the treatment group. The primary end-point, LDL-C, was reduced by 40% and 42% after 4 and 8 weeks of treatment in the atorvastatin treated patients (p<0.001). The reductions in total cholesterol and triglycerides were up to 31% and 23%, respectively. The HDL-C levels increased up to 11% (p=0.043). There were no significant adverse events. Transient increases in CPK levels (10 times) without myalgia were identified in 1 patient. Atorvastatin, 10 mg/day produced significant reductions in LDL-C, total cholesterol and triglycerides and an elevation of HDL-C levels when used as an adjunct to diet in hyperlipidemic patients. The majority of the clinical effects could be attained by week 4. The overall safety profile of atorvastatin was similar to that of placebo. Atorvastatin was considered to be well tolerated in this patient cohort.     

Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension

Initial multiple drug therapy for hypertension achieves greater and quicker reductions and higher blood pressure (BP) control rates than monotherapy. This 8-week, prospective, multicenter, randomized, double-blind study compared the efficacy and safety of the initial combination of aliskiren/amlodipine with amlodipine monotherapy in African Americans with stage 2 hypertension. After a 1- to 4-week washout, patients received aliskiren/amlodipine 150/5 mg or amlodipine 5 mg for 1 week and then were force-titrated to aliskiren/amlodipine 300/10 mg or amlodipine 10 mg for 7 weeks. At week 8, greater reductions in mean sitting systolic BP were obtained with aliskiren/amlodipine (n = 220) than with amlodipine (n = 223) (least squares mean change [standard error of the mean], -34.1 [1.14] mm Hg vs -28.9 [1.12] mm Hg; P<.001). Ambulatory and central BP measures were consistent with clinic BP findings, although these were conducted in a small subset of patients (n = 94 in ambulatory BP monitoring substudy and n = 136 for central BP). More patients achieved goal BP (<140/90 mm Hg) with aliskiren/amlodipine than with amlodipine at week 8 (57.3% vs 48.0%; P = .051). Both treatment groups had similar adverse event rates (35.0% and 32.7%, respectively). The most common adverse events were peripheral edema (7.7% with aliskiren/amlodipine and 9.0% with amlodipine), headache, fatigue, and nausea. The combination of aliskiren/amlodipine reduced peripheral, ambulatory, and central BP more than amlodipine alone with similar tolerability in African Americans with stage 2 hypertension.     

The Use of a Single-Pill Calcium Channel Blocker/Statin Combination in the Management of Hypertension and Dyslipidemia: A Randomized, Placebo-Controlled, Multicenter Study

Poor control of hypertension or dyslipidemia may at least in part be due to these risk factors being treated in isolation. The Caduet in Untreated Subjects Population (CUSP) trial was an 8-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy/safety of the combination of a calcium channel blocker (amlodipine besylate) and a statin (atorvastatin calcium) in a single-pill form (5/20 mg) plus therapeutic lifestyle changes (TLC) compared with placebo plus TLC in patients with comorbid hypertension and dyslipidemia without evidence of cardiovascular disease. At week 4, additional antihypertensive/lipid-lowering medication was permitted. The primary end point was the proportion of patients in whom the dual goal of blood pressure (<140/90 mm Hg) and low-density lipoprotein cholesterol control (<100 mg/dL) was met at week 4. This dual goal attainment was significantly greater with amlodipine/atorvastatin plus TLC compared with placebo plus TLC at week 4 (47.6% vs 1.7%; P <.001), with further improvements at week 8. Most adverse events were mild to moderate. Therapy with single-pill amlodipine/atorvastatin plus TLC in these patients significantly increased dual blood pressure/low-density lipoprotein cholesterol goal attainment compared with placebo plus TLC.