氨氯地平阿托伐他汀钙片治疗高血压并高血脂的疗效

目的:对氨氯地平阿托伐他汀钙片治疗高血压并高血脂的有效性及安全性作出评价.方法:64例原发性高血压伴高血脂患者口服氨氯地平阿托伐他汀钙片,给药剂量为氨氯地平5 mg/阿托伐他汀钙10mg,疗程8周,观察治疗前后临床疗效和不良反应发生率等.结果:氨氯地平阿托伐他汀钙片用药8周后降压的显效率为75.0%,总有效率为93.8%:对TC、TG、HDL-C和LDL-C的有效率分别为90.6%、80.0%、76.6%和81.3%.结论:氨氯地平阿托伐他汀钙片治疗高血压并高血脂安全、有效.     

氨氯地平与氢氯噻嗪联用治疗老年高血压疗效观察

目的研究氨氯地平与氢氯噻嗪联用治疗老年轻、中度原发性高血压的疗效和安全性。方法73例轻、中度老年原发性高血压患者随机分成两组,治疗组服用氨氯地平2.5mg,1次/d;氢氯噻嗪12.5mg,1次/d;对照组单用氨氯地平2.5mg/d,两组均治疗4周。观察用药前后疗效及不良反应。结果治疗后两组血压均较治疗前显著下降(P<0.01)。氨氯地平联用氢氯噻嗪组总有效率为94.7%,单用氨氯地平组总有效率为76.3%,有显著性差异(P<0.05),药物相关不良反应治疗组显著低于对照组(2.8%vs16.2%,P<0.05)。结论氨氯地平与氢氯噻嗪联用疗效高、副作用少,且耐受性和安全性较好。     

阿托伐他汀钙治疗高血压并冠心病的疗效分析

对比评价单用氨氯地平及氨氯地平联合阿托伐他汀钙治疗高血压合并冠心病的疗效。将110例高血压并冠心病者平均分为研究组与对照组。对照组采用氨氯地平治疗,研究组在此基础上给予阿托伐他汀钙治疗。研究组治疗总有效率为96.36%,明显高于对照组的69.09%(P0.05)。研究组血压、血脂各项指标的改善情况明显优于对照组及治疗前(P0.05)。氨氯地平联合阿托伐他汀钙治疗高血压并冠心病疗效明显优于单用氨氯地平,可以有效改善患者的临床症状,提高生活质量,适于临床推广。     

氨氯地平联用氢氯噻嗪治疗原发性高血压疗效观察

目的：观察氨氯地平联用氢氯噻嗪治疗原发性高血压的疗效。方法：将2004年6月0-2006年6月我院心血管门诊中264饲琢发性高血压经过2周药物清洗期，随机分为两组，治疗组156例，对照组108例。对照组给予氨氯地平5mg 1次／d，晨服，治疗2周末如束达标加用氨氯地平5mg，继续服用，疗程4周。治疗组在对照组基础上加用氢氯噻嗪25mg1次／d，晨服，2周末如为达标，加用氨氯地平5mg，继续治疗，疗程4周。治疗前后监测血压、肝肾功、血糖、血钾、心电图。结果：两组血压均明显下降。治疗组达标率明显高于对照组（89．10％／75％），并有统计意义（P〈0．05）。结论：氨氯地平联用氢氯噻嗪治疗高血压有明显疗效，明显优于单用氨氯地平治疗。     

氨氯地平联合贝那普利治疗原发性高血压

目的 观察氨氯地平联合贝那普利治疗原发性高血压的临床疗效.方法 将102例原发性高血压随机分为两组,观察组53例,采用氨氯地平（5 mg）联合贝那普利（10 mg）治疗,对照组49例用氨氯地平（5 mg）单药治疗.治疗4周末若血压≥160/100 mm Hg剂量加倍.共治疗8周,以总有效率和舒张压下降差值作为主要疗效指标.结果 观察组总有效率为88.7%（47/53）、血压达标率为62.3%（33/53）;对照组总有效率为63.35%（31/49）、血压达标率为34.7%（17/49）.治疗前两组比较差异无统计学意义（P〉0.05）.治疗后两组间总有效率、血压达标率比较差异均有统计学意义（P〈0.001）.结论 氨氯地平联合贝那普利治疗原发性高血压患者的降压疗效明显优于氨氯地平单药治疗,值得临床推广应用.     

氨氯地平阿托伐他汀钙片治疗高血压并高血脂的效果分析

目的探讨氨氯地平阿托伐他汀钙片治疗高血压并高血脂患者的疗效。方法选取我院2012年6月~2013年11月收治的98例高血压合并高血脂患者,随机分为两组:对照组49例,给予氨氯地平治疗;观察组49例,给予复方氨氯地平阿托伐他汀钙治疗。比较两组疗效。结果观察组和对照组治疗前后,收缩压和舒张压均有所改善,差异具有统计学意义(P0.05);两组治疗后比较,差异具有统计学意义(P0.05)。观察组和对照组治疗前后,TG、TC、LDL及HDL等血脂指标较治疗前明显改善,差异具有统计学意义(P0.05);两组治疗后比较,差异均具有统计学意义(P0.05)。两组降血压总有效率分别为93.9%和77.6%,两组差异具有统计学意义(P0.01)。两组降血脂总有效率分别为93.9%和83.7%,两组差异具有统计学意义(P0.05)。结论高血压并高血脂患者应用氨氯地平阿托伐他汀钙片治疗疗效显著,能够同时有效的降血压和降血脂,值得在临床推广使用。     

苯磺酸左旋氨氯地平联合依那普利治疗中度原发性高血压疗效观察

目的:观察苯磺酸左旋氨氯地平联合马来酸依那普利治疗中度原发性高血压的疗效及不良反应,探讨抗高血压药物联合应用的可行性.方法:将120例高血压患者随机分为观察组厦对照A组、对照B组各40例.对照A组给予苯磺酸左旋氨氯地平片5mg,1次/d,口服;对照B组给予马来酸依那普利片10 mg,1次/d,口服;观察组给予苯磺酸左旋氨氯地平片5 mg联合马来酸依那普利片10 mg,1次/d,口服.3组疗程均为4周,观察治疗前、后患者血压、心率的变化,比较3组不良反应发生率.结果:观察组降压总有效率97.5%,高于对照A组(82.5%)和对照B组(67.5%),差异有统计学意义(P<0.05,P<0.01);对照A组心率较治疗前明显加快(P<0.05),对照B组及观察组心率与治疗前比较差异无统计学意义(P>0.05).观察组不良反应发生率2.5%,低于对照A组(12.5%)和对熙B组(7.5%),差异有统计学意义(P<0.05).结论:苯磺酸左旋氨氯地平联合马来酸依那普利治疗中度原发性高血压疗效满意.     

吲哒帕胺与氢氯噻嗪分别联用氯沙坦治疗高血压伴左室肥厚比较

目的　比较吲哒帕胺 (商品名 :寿比山 )联用氯沙坦 (商品名 :科素亚 )与氢氯噻嗪 (商品名 :双氢克尿噻 )联用氯沙坦长期治疗中、重度高血压的疗效和对左室肥厚 (LVH)、左室舒张功能的影响。方法　 86例高血压伴左室肥厚患者随机分为两组 ,停用降压药 1周。一组用吲哒帕胺 1.5～ 2 .5mg/d联用氯沙坦 5 0～ 10 0mg/d口服治疗 4 8周 ;另一组用氢氯噻嗪 12 .5～ 2 5mg/d联用氯沙坦 5 0～ 10 0mg/d口服治疗 4 8周。 结果　两组血压均显著下降 (P <0 .0 5 ) ,吲哒帕胺联用氯沙坦组和氢氯噻嗪联用氯沙坦组降压总有效率分别为 92 .9% ,90 .0 % (P >0 .0 5 )。两组均可改善LVH及左室舒张功能 (P <0 .0 1) ,但吲哒帕胺联用氯沙坦组改善更明显 ,(P <0 .0 1)。两组不良反应均较少 ,对血脂、血糖代谢的影响吲哒帕胺联用氯沙坦组略优于氢氯噻嗪联用氯沙坦组。结论　吲哒帕胺联用氯沙坦治疗中、重度高血压伴LVH患者的疗效和安全性优于氢氯噻嗪联用氯沙坦 ,是一组适于长程治疗的满意组合     

氯沙坦、氨氯地平单独和联用逆转高血压左室肥厚的对比研究

【目的】探讨氯沙坦、氨氯地平单独和联用治疗高血压左室肥厚的临床疗效。【方法】120例高血压左室肥厚患者采用随机方法,分为氯沙坦组40例;氨氯地平组40例;氯沙坦联用氨氯地平组40例。分别给予氯沙坦（100mg／d）、氨氯地平（10mg／d）、氯沙坦（50mg／d）＋氨氯地平（5mg／d）口服,疗程结束前后行偶测血压、24h动态血压监测和多普勒超声心动图检查。【结果】三组偶测血压、24h动态血压监测和超声心动图指标用药后均较用药前显著下降（P〈0．01）;两单用组相比,治疗后各项指标无显著性差异（P〉0．05）;联合用药组降压幅度及超声心动图指标的改善与单一用药组相比,均具有显著性差异（P〈0．05）。且联合用药组不良反应少。【结论】氯沙坦联用氨氯地平治疗高血压左室肥厚效果佳,不良反应少,费用降低,为高血压左室肥厚比较优选的治疗方案。     

氨氯地平阿托伐他汀钙片治疗高血压合并冠心病的疗效观察

选取我院2014年1月~2015年3月收治的100例高血压联合冠心病患者。随机分为对照组和观察组各50例。观察组采用常规治疗,硝苯地平控释片30mg/次,1次/d,疗程为1.5个月;对照组在一般常规治疗的基础上采用氨氯地平阿托伐他汀钙片治疗,用药为5~10mg/次,1次/d,疗程为1.5个月。对两组治疗前后的临床疗效进行比较。结果冠心病患者在治疗1.5月后,对照组和观察组的血压显著下降,两组在心痛、血压、药量等方面都有显著的好转,观察组的心绞痛症状得到改善,总有效率92.5%与对照组62.3%,两组差异具有统计学意义(P<0.05);观察组硝酸甘油片的用量有所减小,总有效率95.6%,对照组为50.2%,两组比较差异具有统计学意义(P<0.05);观察组心电图也得到明显好转,总有效率93.6%与对照组51.3%,两组比较差异具有统计学意义(P<0.05);观察组用药后出现不良反应的发生率是4%,对照组为12%,两组比较差异具有统计学意义(P<0.05)。观察氨氯地平阿托伐他汀钙片治疗高血压合并冠心病的临床治疗效果显著,值得推广和应用。     

氨氯地平阿托伐他汀钙片治疗高血压合并冠心病的临床效果

目的探讨氨氯地平阿托伐他汀钙片治疗高血压合并冠心病的临床效果。方法将我院收治的164例高血压合并冠心病患者按治疗方式不同分为对照组(82例,硝苯地平缓释片)和观察组(82例,氨氯地平阿托伐他汀钙片)。比较两组的治疗效果。结果治疗后,两组的舒张压、收缩压、TC、TG、LDL-C、CPR、IL-12、ET水平均降低,HDL-C及NO水平均升高,且观察组优于对照组(P<0.05)。结论氨氯地平阿托伐他汀钙片能改善高血压合并冠心病患者的血压、血脂水平,降低血清炎性因子水平,保护血管内皮功能。     

Amlodipine besylate/olmesartan medoximil fixed combination for the treatment of hypertension

National and international guidelines recommend the use of combination drugs as a first-line therapy for persons with stage 2 hypertension (blood pressure >160/100 mmHg). Although hypertension is common (30% of adults in the USA), its control to recommended blood pressure levels of under 140/90 mmHg remains low, at 36.8%. In the past, fixed-drug combinations included a diuretic with another antihypertensive drug. Recently, combinations of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers mostly with dihydropyridine calcium channel blockers have been developed and approved for the treatment of hypertension. One of these, olmesartan medoxomil in combination with amlodipine besylate has been shown to be effective and safe for the treatment of hypertension. In a large, randomized, placebo-controlled study (Combination of Olmesartan medoxomil and Amlodipine besylate in Controlling High blood pressure [COACH]) of 1940 patients, the high-dose combinations of olmesartan medoxomil and amlodipine besylate 40/10 mg/day reduced the sitting systolic and diastolic blood pressure by 29/19 mmHg from baseline (p < 0.001) and resulted in 54% of patients achieving blood pressure goals. It also decreased the pedal edema induced by amlodipine monotherapy 10 mg/day by 36.1%. This drug combination, besides being effective, is also safe and well tolerated.     

Simultaneous treatment of hypertension and dyslipidaemia may help to reduce overall cardiovascular risk: focus on amlodipine/atorvastatin single-pill therapy

Single-pill amlodipine besylate/atorvastatin calcium (Caduet), Pfizer Inc, NY, USA) is the first therapy aimed at the simultaneous treatment of hypertension (HTN) and dyslipidaemia (DYS). The benefits of lowering blood pressure (BP) in patients with HTN and lowering cholesterol in patients with DYS are well known and well studied. However, worldwide, many patients with HTN have concomitant DYS, which places them at greater risk for cardiovascular disease compared with patients with just one of these risk factors. Clinical trials have demonstrated that amlodipine plus atorvastatin can be safely co-administered across the dose range. Single-pill amlodipine/atorvastatin reduces both BP and cholesterol and may help to improve the management of patients with concomitant HTN and DYS.     

Effects of amlodipine plus atorvastatin association in hypertensive hypercholesterolemic patients

Therapies that lower blood pressure or lipid levels slow the progression of atherosclerosis, and reduce morbidity and mortality in patients with hypertension or atherosclerotic disease. A combination tablet containing both amlodipine besylate and atorvastatin calcium has recently been approved for the treatment of hypertension and dyslipidemia in a growing number of countries. We decided to undertake a thorough literature search to evaluate the effects of amlodipine and atorvastatin in hypertensive hypercholesterolemic patients on blood pressure values, lipid profile values and, when available, data on small- and large-artery compliance, left ventricular mass index, and inflammatory parameters. From the data collected, it emerged that in hypertensive and hypercholesterolemic patients, the combination of amlodipine plus atorvastatin is more effective than the single drugs alone in reducing blood pressure and in improving lipid profile. Furthermore the combination of amlodipine plus atorvastatin also improved small-artery compliance, inflammatory markers, left ventricular hypertrophy and reduced uric acid faster and more effectively than the single drugs taken alone. For these reasons, the combination of amlodipine plus atorvastatin could be the treatment of choice in hypertensive and hypercholesterolemic patients.     

Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (The STRONG DUET Study)

Introduction

The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe.

Methods

This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk.

Results

Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe.

Conclusion

Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.     

Efficacy and tolerability of a switch to fixed-dose combination therapy with amlodipine besylate/benazepril hydrochloride after monotherapy with amlodipine besylate: Data from the African-American subpopulation of a practice-based, open-label study (the LOGIC study)

Background: The LOGIC (LOtrel: Gauging Improved Control) study assessed the efficacy and tolerability of switching from amlodipine besylate monotherapy to fixed-dose combination therapy with amlodipine besylate/benazepril hydrochloride (HCI) in patients who were experiencing uncontrolled blood pressure (BP) or edema with monotherapy.Objective: This article reports the efficacy and tolerability of amlodipine besylate/benazepril HCI combination therapy in the predefined African-American population of the LOGIC study.Methods: This multicenter (1518 centers across the United States), practice-based, open-label, clinical trial enrolled patients with mild to moderate essential hypertension. Patients in group 1 had uncontrolled BP (sitting diastolic BP [DBP] ≥90 mm Hg and ≤110 mm Hg) during treatment with amlodipine besylate monotherapy 5 or 10 mg/d, and those in group 2 had controlled BP (sitting DBP ⩽90 mm Hg), but also had experienced edema during amlodipine besylate monotherapy. Participants were instructed to discontinue amlodipine besylate and were given amlodipine besylate/benazepril HCl 5/10 mg/d or 5/20 mg/d for 4 weeks. For group 1, the primary efficacy outcome was the change in mean sitting DBP (MSDBP) from baseline to week 4; a secondary efficacy outcome was the change in mean sitting systolic BP (MSSBP) from baseline to week 4. The primary efficacy outcome for group 2 was the percentage of patients whose edema improved with the switch to combination therapy. The secondary efficacy variables in group 2 were the changes in MSDBP and MSSBP from baseline to week 4. Patients in groups 1 and 2 were questioned about any adverse events that may have occurred since the previous visit. At both study visits, medications were reviewed, and the level of edema was assessed.Results: A total of 2055 African-American patients were enrolled in the study. At study end, African-American patients in group 1 (n = 1422 assessable patients) experienced significant reductions in MSSBP (13.9 mm Hg) and MSDBP (10.4 mm Hg) from those achieved during amlodipine besylate monotherapy (both P < 0.001). In group 2 (n = 266 assessable patients), 81% of African-American patients reported improvement in edema, and BP remained well controlled.Conclusions: In this study of an African-American subpopulation of patients with mild to moderate essential hypertension who had uncontrolled BP while receiving amlodipine besylate monotherapy, switching from amlodipine besylate monotherapy to fixed-dose amlodipine besylate/benazepril HCl combination therapy reduced BP to a greater extent than with amlodipine besylate alone, and reduced the incidence of edema in patients who were edematous but who had controlled BP. Fixed-dose combination therapy with amlodipine besylate/benazepril HCI has the potential to improve BP control, leading to improved clinical outcomes and enhanced treatment compliance.     

Comparison of efficacy and tolerability of amlodipine orotate versus amlodipine besylate in adult patients with mild to moderate hypertension: a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 8-week follow-up, noninferiority trial

OBJECTIVE: The purpose of this study was to compare the efficacy and tolerability of amlodipine orotate with those of amlodipine besylate in Korean patients with mild to moderate hypertension. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study was designed as a noninferiority study. To be included in the study, previously untreated patients had to have a sitting diastolic blood pressure (SiDBP) of 90 to 109 mm Hg. Previously treated patients had to discontinue their current annhypertensive medications and have a baseline SiDBP between 90 and 109 mm Hg after a 2-week washout period. Patients who met the inclusion criteria were randomly assigned to receive 5 mg amlodipine orotate or 5 mg amlodipine besylate for 8 weeks. The medication dose was doubled (10 mg QD for either amlodipine orotate or amlodipine besylate) 4 weeks after enrollment if SiDBP was >or=90 mm Hg. The primary efficacy analysis was noninferiority of the difference in mean trough SiDBP changes from baseline for amlodipin eorotate as compared with amlodipine besylate after 8 weeks of treatment. For the secondary efficacy analysis, 2 other measures were analyzed after 8 weeks of treatment. The SiDBP response rate was defined as an SiDBP measurement<90 mm Hg at the last clinical follow-up visit or an absolute reduction of >or=10 mm Hg in SiDBP from baseline until the last clinical follow-up visit. In addition, noninferiority of the difference in mean trough sitting systolic blood pressure (SiSBP) changes from baseline was analyzed for amlodipine orotate as compared with amlodipine besylate. The drug compliance rate was estimated by pillcount. RESULTS: Eligible patients (n=109; 43 women and 66 men) were randomly assigned to receive amlodipine orotate (n=53) or amlodipine besylate (n=56). No significant differences were found in sex, age, weight, or current smoking between the groups (all, P=NS). The proportion of patients with previous antihypertensive medications was not different between the groups (47.2% [25/53] in the amlodipine orotate group and 50.0% [28/56] in the amlodipine besylate group; P=NS). No significant differences were found in baseline SiDBP (mean [SD], 100 [6] mm Hg [range, 90-109 mm Hg] in the amlodipine orotate group and 100 [6] mm Hg [range, 90-108 mm Hg] in the amlodipine besylate group; P=NS) or in baseline SiSBP (mean [SD], 149 [14] mm Hg [range, 125-179 mm Hg] in the amlodipine orotate group and 146 [10] mm Hg [range, 123-167 mm Hg] in the amlodipine besylate group; p=NS). The mean (SD) changes in SiDBP were -15.6 (6.3) mm Hg for the amlodipine orotate group and -14.5 (5.5) mm Hg for the amlodipine besylate groups was 1.1 (5.9) mm Hg (95% CI, -0.87 to infinity), and because the lower boundary of the 95% CI was greater than -5 mm Hg, amlodipine orotate was considered noninferior to amlodipine besylate. The response rate was 48 of 51 (94.1%) in the amlodipine orotate group compared with 50 (92.6%) of 54 in the amlodipine besylate group after 8 weeks of treatment (P=NS). The mean (SD) compliance rates were 97.6% (3.6%) in the amlodipine orotate group and 96.5% (4.3%) in the amlodipine besylate group (P=NS). The incidence of drug-related adverse events (AEs) was similar between the groups (1/53 [1.9%]) in the amlodipine orotate group vs 4/55 [7.3%] in the amlodipine besylate group; P=NS). The most common drug-related AE overall was peripheral edema (2/55 [3.6%]), and the most common of all the AEs was upper respiratory tract infection (4/55 [7.3%]) in the amlodipine besylate group. The most common drug-related AE was headache (1/53 [1.9%]) in the amlodipine orotate group and peripheral edema (2/55 [3.6%]) in the amlodipine besylate group. No severe AEs were found in either group. CONCLUSION: The reduction in SiDBP after 8 weeks of amlodipine orotate treatment was noninferior to that of amlodipine besylate in these Korean patients with mild to moderate hypertension. The SiDBP response rate and the reduction in SISBP after 8 weeks of amlodipine orotate treatment were not significantly different from those of amlodipine besylate treatment. Both agents were wel tolerated.     

Amlodipine/atorvastatin: the first cross risk factor polypill for the prevention and treatment of cardiovascular disease

In 2002, the World Health Organization estimated that over 58% of cardiovascular disease in North America is due to 'both blood pressure and cholesterol higher than optimal'. Unfortunately, less than a third of patients with both conditions are identified, and fewer than one in ten reach the treatment goals for both factors. Adherence to treatment is notably improved when therapy is initiated simultaneously. Combination therapy of amlodipine besylate (Norvasc, Pfizer Ltd) with atorvastatin calcium (Lipitor, Pfizer Ltd), marketed as Caduet (Pfizer Ltd) is the first dual-therapy compound designed to treat hypertension and/or angina and dyslipidemia concurrently with a single daily pill in the full range of dosing combinations. Amlodipine/atorvastatin retains the safety and efficacy of its parent compounds whilst simplifying the management of these comorbid conditions, in what may be considered the first version of a polypill.     

Results of a multicenter, 8-week, parallel-group, randomized,double-blind, double-dummy, Phase III clinical trial to evaluate the efficacy and tolerability of amlodipine maleate versus amlodipine besylate in Korean patients with mild to moderate hypertension

BACKGROUND: Recently, amlodipine maleate was developed and tested in preclinical and Phase I clinical trials in Korea. The studies found pharmacokinetics and pharmacodynamics similar to those of amlodipine besylate. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of amlodipine maleate with those of amlodipine besylate in Korean patients with mild to moderate hypertension. METHODS: This was a multicenter, 8-week, parallel-group, randomized, double-blind, double-dummy, Phase III clinical trial. Eligible patients were Korean, aged 18 to 75 years, had hypertension, and were either taking antihypertensive medications or had a documented sitting diastolic blood pressure of 90 to 109 mm Hg. After a washout period of 2 weeks, patients were randomized to amlodipine maleate or amlodipine besylate for 8 weeks. In both groups, the medications were initiated at 5 mg QD. At day 29, the medication dose was increased to 10 mg QD if sitting diastolic blood pressure (SiDBP) was > or = 90 mm Hg. RESULTS: One hundred eighteen patients were enrolled. Fifty-seven patients received amlodipine maleate (29 men, 28 women; mean [SD] age, 49.0 [11.4] years) and 61 received amlodipine besylate (35 men, 26 women; mean [SD] age, 51.6 [9.4] years). Baseline mean (SD) values for sitting systolic blood pressure and SiDBP were 152.0 (12.2) mm Hg and 98.1 (5.6) mm Hg, respectively, for the amlodipine maleate group and 153.4 (14.0) mm Hg and 98.1 (5.5) mm Hg, respectively, for the amlodipine besylate group. In this population, amlodipine maleate was not inferior to amlodipine besylate: the lower limit of the 2-sided 95% CI for the treatment difference in SiDBP was greater than -4 mm Hg. The between-group difference in SiDBP response rate (the proportion of patients who experienced adequate SiDBP reductions) did not reach statistical significance: 85.7% (42/49) for the amlodipine maleate group and 91.8% (45/49) for the amlodipine besylate group. Compliance rates were similar between groups, with mean (SD) compliance rates of 97.4% (2.8%) and 97.1% (3.6%) in the amlodipine maleate and amlodipine besylate groups, respectively. Also, there were no significant differences in the incidences of drug-related clinical and laboratory adverse events; the most common were headache, flushing, facial edema, and paresthesia. CONCLUSION: In this population, the efficacy and tolerability observed with amlodipine maleate were similar to those seen with amlodipine besylate.     

厄贝沙坦与苯磺酸氨氯地平治疗轻中度原发性高血压的疗效比较

目的:比较厄贝沙坦(安博维)与苯磺酸氨氯地平(络活喜)治疗轻中度原发性高血压的降压疗效.方法:将2008年1月至2009年12月于明确诊断为轻中度原发性高血压患者100例随机分为安博维组和络活喜组各50例,分别应用安博维和络活喜治疗,比较两组治疗8周时的降压疗效.结果:治疗2周、4周、6周和8周时安博维组和络活喜组的降压有效(率)分别为35例(70%)、38例(76%)、41例(82%)、43例(86%)和36例(72%)、39例(78%)、40例(80%)、42例(84%),两组各疗程均无显著性差异.结论:厄贝沙坦(安博维)与苯磺酸氨氯地平(络活喜)治疗轻中度原发性高血压均可获良好疗效,且无明显不良反应.