小剂量氨氯地平联合用药治疗老年高血压的疗效和安全性评价

目的 评价小剂量氨氯地平联合复方阿米洛利或者替米沙坦治疗老年高血压的临床疗效和安全性.方法 采用随机开放对照盲终点评估的方法,入选老年原发性高血压患者106例,随机分为氨氯地平+复方阿米洛利(阿米洛利组)和氨氯地平+替米沙坦组(替米沙坦组),均服药12 w,每2周随访一次,观察收缩压、舒张压、心率、降压达标率、有效率和不良反应.结果 治疗第2周末,阿米洛利组和替米沙坦组的达标率分别为58.5%和47.2%,组间比较有统计学差异(P<0.05).而治疗12 w后,两组降压达标率分别为67.9%和71.7%,有效率分别为81.1%和83.0%,组间比较差异均无统计学意义(P>0.05).阿米洛利组收缩压下降值为(24.3±15.8)mmHg,舒张压下降值为(15.2±9.2)mmHg,替米沙坦组收缩压下降值为(26.8±13.4)mmHg,舒张压下降值为(15.7±9.4)mmHg,较治疗前均有显著差异(P<0.01);两组不良反应发生率分别为9.4%和7.6%(P>0.05),实验室检查均无明显改变,未见低血钾及体位性低血压的发生.结论 小剂量氨氯地平联合复方阿米洛利或替米沙坦能显著降低老年高血压患者血压,耐受性好,不良反应少;氨氯地平联合复方阿米洛利方案在尽早达标方面更具优势.     

替米沙坦并胺碘酮对高血压伴房颤患者血压、左心房及房颤的影响

目的:探讨替米沙坦联合胺碘酮对高血压合并房颤患者的血压、左心房内径及房颤复发的影响。方法:选择2014年1月至2016年1月我院高血压合并房颤患者186例,随机均分为氨氯地平组(接受氨氯地平联合胺碘酮治疗)和替米沙坦组(接受替米沙坦联合胺碘酮治疗),疗程6周。观察比较两组治疗前后患者血压、左心房内径的变化情况及6个月内房颤复发的情况。结果:与治疗前比较,两组治疗后收缩压、舒张压均显著下降,左心房内径显著减小(P均0.01);治疗后,与氨氯地平组比较,替米沙坦组患者的血压[(137±6)/(85±7)mm Hg比(122±5)/(77±8)mm Hg]、左心房内径[(38.7±2.3)mm比(35.3±3.4)mm]、6个月内房颤复发率(37.6%比22.6%)均显著降低(P均0.01)。结论:对于高血压合并房颤患者,替米沙坦联合胺碘酮较氨氯地平联合胺碘酮更显著地降低血压和左心房内径,且明显降低房颤的复发率,值得推广。     

CHIEF:中国高血压干预效果研究-初始低剂量钙离子拮抗剂为基础的联合方案治疗高血压的随机临床研究阶段报告-1

目的 探讨以氨氯地平为基础的联合治疗方案,对高血压患者血压达标及血管事件的影响.方法 为多中心随机开放对照盲终点评估的研究.50～79岁伴心血管病危险因素的高血压患者知情同意后,随机分为氨氯地平+复方阿米洛利组(A组,n=5805)或氨氯地平+替米沙坦组(B组,n=5805),主要终点是心血管病复合事件,治疗随访 4 年. 结果 2007 年 10 月至 2008 年 10 月间 180 家合作单位共随机 13 134 例患者,其中 11 610 例数据初步分析:基线平均血压水平 157/93 mmHg,随机治疗后第 8 周 A 组与 B 组血压分别降至 133.0/80.9 mm Hg 和 132.9/80.3 mm Hg.治疗第 8周 A 组血压控制率达 71.5%;B 组血压控制率达 72.0%.结论 以氨氯地平为基础的联合降压治疗达到了良好的血压控制.     

小剂量氨氯地平联合复方阿米洛利治疗老年高血压的疗效及安全性

目的 分析小剂量氨氯地平联合复方阿米洛利治疗老年高血压的临床疗效和安全性.方法 将老年高血压患者112例随机分为两组,观察组56例患者给予氨氯地平+复方阿米洛利进行治疗,对照组给予氨氯地平+替米沙坦进行治疗;治疗期间半个月随访一次,观察两组患者血压、心率、治疗效果及不良反应.结果 两组患者治疗2w、4 w时,平均SBP较治疗前均有显著下降,治疗前、后具有显著性差异(P＜0.05),且观察组平均SBP下降较对照组明显,两组比较具有显著性差异(P＜0.05).两组第2周血压比较,观察组达标患者明显多于对照组(P＜0.05).后期两组治疗效果比较无显著性差异(P＞0.05).两组均未见明显不良反应,差异无统计学意义(P＞0.05).结论 小剂量氨氯地平联合复方阿米洛利或替米沙坦能显著降低老年高血压患者血压,耐受性好,不良反应少;氨氯地平联合复方阿米洛利方案在尽早达标方面更具优势.     

氨氯地平联合复方阿米洛利或替米沙坦治疗原发性高血压疗效比较

目的比较两种小剂量联合降压方案对原发性高血压患者降压疗效比较。方法将66例原发性高血压患者随机分为两组,分别给予氨氯地平+复方阿米洛利、氨氯地平+替米沙坦两种不同降压方案,于治疗前及治疗后4周、12周、36周、48周、96周,测定各组的血压变化。结果氨氯地平+复方阿米洛利组与氨氯地平+替米沙坦患者经治疗后,收缩压与舒张压与治疗前比较均有显著降低(P<0.05或P<0.01),但两组间收缩压与舒张压差别无统计学意义(P>0.05)。结论两组降压方案均能有效控制血压,作用相当,两组治疗前后心率及各项化验检测指标无显著性变化,不良反应小,均能耐受。     

氨氯地平联合复方阿米洛利或联合替米沙坦对高血压患者颈动脉粥样硬化的对比研究

目的 探讨氨氯地平联合复方阿米洛利与氨氯地平联合替米沙坦对高血压患者颈动脉粥样硬化的影响.方法 将原发性高血压患者随机分为氨氯地平联合复方阿米洛利组（A组,n=207）和氨氯地平联合替米沙坦组（B组,n=211）.分别观察治疗12和24月两组药物的降压效果,应用高分辨超声技术检测两组患者颈动脉内膜中层厚度(IMT)、血...     

氨氯地平加替米沙坦对轻、中度高血压的疗效及与AVP和NO的关系

目的 观察氨氯地平加替米沙坦对轻、中度高血压的疗效，探讨高血压患者血管加压素(AVP)和一氧化氮（NO）的变化与疗效的关系。方法 将60例轻、中度高血压病患者（包括:正在服用降压药的高血压病患者和新发病例没有服用降压药的患者）随机分为:氨氯地平组，替米沙坦组和氨氯地平＋替米沙坦组（氨+替组）,每组各20例。测定各组治疗前后血压的变化。采用放免法、比色法测定各组患者治疗前后血浆AVP和NO的含量。结果 ①氨氯地平组、替米沙坦组及氨＋替组治疗前收缩压（SBP）分别为:(146.31±3.15)mmHg、(145.92±2.71)mmHg及(146.00±2.42)mmHg；舒张压(DBP)分别为:(93.77±2.39)mmHg、(92.54±2.68)mmHg及(94.93±1.15)mmHg。在治疗6个月后，SBP分别为:(126.69±1.74)mmHg、(126.08±1.52)mmHg及(102.71±2.20)mmHg；DBP分别为:(80.76±1.13)mmHg、(81.00±0.80)mmHg和(76.11±1.36)mmHg，与治疗前比较明显降低（P<0.05）。氨+替组患者的SBP和DBP均明显低于氨氯地平组和替米沙坦组（P<0.05）；氨氯地平组与替米沙坦组比较无显著差异。②治疗1月、2月末，氨+替组患者的血压达标率均明显高于氨氯地平组和替米沙坦组（P<0.05）；氨氯地平组和替米沙坦组比较无显著差异。③氨氯地平组、替米沙坦组及氨＋替组治疗前血浆NO的含量分别为:(12.77±0.23)μmol/L、(11.68±0.35)μmol/L及(10.09±1.04)μmol/L；治疗6个月后其含量分别为:(18.50±2.14)μmol/L、(19.07±1.96)μmol/L及(25.47±1.84)μmol/L，与治疗前比较差异显著（P<0.05）。氨+替组患者NO的含量明显高于氨氯地平组和替米沙坦组（P<0.05）；氨氯地平组和替米沙坦组比较无显著差异。④氨氯地平组、替米沙坦组及氨＋替组患者治疗前血浆AVP的含量分别为:(34.71±4.36)ng/L、(33.07±3.77)ng/L及(35.06±4.12)ng/L；治疗6个月后分别为:(22.35±2.71)ng/L、(24.12±3.11)ng/L及(17.98±1.79)ng/L,与治疗前比较差异显著（P<0.05）。氨+替组血浆AVP的含量低于氨氯地平组和替米沙坦组（P<0.05），氨氯地平组和替米沙坦组组间比较无显著差异。结论 ①3个组均能有效控制血压，但氨+替组的降压效果更佳。②3个组在显著降低血压的同时，均伴有血浆AVP含量降低和血浆NO含量增高，氨+替组的效果更明显，提示AVP和NO参与了高血压的发生发展，可作为观察高血压疗效的指标。     

复方替米沙坦对单药控制不良高血压患者的有效性和安全性

目的 评价复方替米沙坦在替米沙坦单药治疗无充分反应时中国高血压患者中的有效性和安全性.方法 多中心、随机、双盲、双模拟临床试验.经1周安慰剂筛选期,699例符合入选标准的轻、中度高血压患者进入80 mg替米沙坦单药开放治疗期.345例对替米沙坦单药开放治疗8周无充分反应[平均坐位舒张压≥90 mm Hg(1 mm Hg=0.133 kPa)]的患者进入为期8周的随机双盲治疗期.175例患者进入复方替米沙坦治疗组(80 mg替米沙坦加12.5 mg氢氯噻嗪),170例进入80 mg替米沙坦单药治疗组.每次随访测量坐位和立位的收缩压和舒张压谷值,记录不良事件.筛选期以及开放和随机双盲治疗期结束时进行实验室和心电图检查.结果 (1)与开放治疗期结束(基线)比较,随机双盲治疗8周后,复方替米沙坦组坐位舒张压谷值平均下降10.1 mm Hg,替米沙坦单药组平均下降7.7 mm Hg,两组间比较P=0.0017.复方替米沙坦组坐位收缩压谷值平均下降14.2 mm Hg,替米沙坦单药组平均下降7.4 mm Hg,两组间比较P＜0.0001.(2)与基线比较,随机双盲治疗8周后,复方替米沙坦组立位舒张压和收缩压谷值平均下降幅度大于替米沙坦单药组,两组间比较P=0.0350和P＜0.0001.(3)按照平均坐位舒张压谷值＜90 mm Hg和(或)与基线值相比降低≥10 mm Hg评价,随机双盲治疗8周后,复方替米沙坦组有效率为74.6%(129例患者),替米沙坦单药组为59.2%(100例患者),两组间比较P=0.0016.(4)在随机双盲期,两组与试验药物有关的不良事件发生率分别为3.5%和3.6%,两组间比较P＞0.05.结论 替米沙坦单药治疗无充分反应的中国高血压患者,复方替米沙坦每日口服一次能够进一步降低血压,且安全性良好.     

以钙拮抗剂为基础的联合降压对高血压患者中心动脉压和脉搏波传导速度的对比研究

目的探讨氨氯地平联合复方阿米洛利或联合替米沙坦对高血压患者中心动脉压(CAP)和脉搏波传导速度(PWV)的影响。方法采用随机抽样方法选取2008-03-2011-02济南4个社区查体人群中高血压患者275例,年龄50～79岁。随机分为氨氯地平联合复方阿米洛利组(A组,134例)或联合替米沙坦组(B组,141例)。排除68例应用调脂药物的患者后,对207例(A组,102例;B组,105例)患者进行分析。在基线、治疗12、24月,分别应用动脉脉搏波分析仪测量CAP和增强指数,应用PWV测定仪测定颈桡动脉PWV(crPWV)。结果两组治疗12月后,中心动脉收缩压、舒张压、脉压,增强指数及crPWV均明显降低。24月时,B组crPWV较12月时进一步降低[(8.9±2.0)比(9.5±2.2)m/s,P<0.05],然而A组患者的crPWV并未随着时间的延长进一步改善(P>0.05)。治疗12和24月后,B组crPWV下降幅度[12月(-3.5±2.1)m/s,24月(-4.1±2.3)m/s]均较A组[12月(-2.3±1.6)m/s,24月(-2.5±1.8)m/s]更明显(均P<0.01)。结论以钙拮抗剂氨氯地平为基础,联合替米沙坦或复方阿米洛利均能够降低CAP、增强指数和改善大动脉顺应性,其中氨氯地平联合替米沙坦改善动脉弹性更明显,并且随着治疗时间的延长,效果更佳。     

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.     

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.     

Combination therapy of amlodipine/benazepril versus monotherapy of amlodipine in a practice-based setting

BACKGROUND: Community-based studies are conducted to determine the degree to which therapeutic interventions will succeed in real world settings. This large practice-based clinical trial assessed the efficacy and tolerability of fixed-dose combination therapy with amlodipine/benazepril, compared with amlodipine monotherapy, in patients with mild-to-moderate hypertension. METHODS: Hypertensive patients currently taking amlodipine were selected based on one of two criteria: inadequate blood pressure (BP) control on amlodipine (diastolic BP [DBP] > or = 90 mm Hg; group 1), or inability to tolerate amlodipine (DBP < or = 90 mm Hg, but with edema; group 2). Eligible patients were switched from 5 or 10 mg of amlodipine to 5/10 mg or 5/20 mg of amlodipine/benazepril for 4 weeks. In group 1 (n = 6410), primary efficacy outcome was change in mean sitting DBP. A secondary efficacy outcome was change in mean sitting systolic BP (SBP). In group 2 (n = 1502), primary efficacy outcome was the percentage of patients whose edema improved during therapy with amlodipine/benazepril when compared with amlodipine monotherapy. RESULTS: In group 1, mean sitting DBP declined from 96.5 mm Hg at baseline to 84.9 mm Hg at week 4, a mean reduction of 11.5 mm Hg (95% confidence interval [CI] -11.8 to -11.3 mm Hg; P < .001). From baseline to week 4, mean sitting SBP declined from 152.9 mm Hg to 137.3 mm Hg, a mean reduction of 15.6 mm Hg (95% CI -16.0 to -15.2 mm Hg; P < .001). In group 2, 85% (95% CI 83%-87%) experienced some improvement in edema compared with baseline levels. CONCLUSIONS: Fixed-dose combination antihypertensive agent amlodipine/benazepril was safe and effective for patients who experienced either inadequate BP control or edema with amlodipine monotherapy.     

Efficacy and duration of benazepril plus amlodipine or hydrochlorothiazide on 24-hour ambulatory systolic blood pressure control

The combination of benazepril plus amlodipine was shown to be more effective than benazepril plus hydrochlorothiazide in reducing cardiovascular events in the Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial. There was a small difference in clinic systolic blood pressure between the treatment arms favoring benazepril plus amlodipine. Ambulatory blood pressure monitoring provides a more rigorous estimate of blood pressure effects. A subset of 573 subjects underwent ambulatory blood pressure monitoring during year 2. Readings were obtained every 20 minutes during a 24-hour period. Between-treatment differences (benazepril plus amlodipine versus benazepril plus hydrochlorothiazide) in mean values were analyzed using ANOVA. Treatment comparisons with respect to categorical variables were made using Pearson's χ2. At year 2, the treatment groups did not differ significantly in 24-hour mean daytime or nighttime blood pressures (values of 123.9, 125.9, and 118.1 mm Hg for benazepril plus amlodipine group versus 122.3, 124.1, and 116.9 for the benazepril plus hydrochlorothiazide group), with mean between-group differences of 1.6, 1.8, and 1.2 mm Hg, respectively. Blood pressure control rates (24-hour mean systolic blood pressure <130 mm Hg on ambulatory blood pressure monitoring) were greater than 80% in both groups. Nighttime systolic blood pressure provided additional risk prediction after adjusting for the effects of drugs. The 24-hour blood pressure control was similar in both treatment arms, supporting the interpretation that the difference in cardiovascular outcomes favoring a renin angiotensin system blocker combined with amlodipine rather than hydrochlorothiazide shown in the ACCOMPLISH trial was not caused by differences in blood pressure, but instead intrinsic properties (metabolic or hemodynamic) of the combination therapies.     

奥美沙坦酯和氨氯地平联合治疗原发性高血压的研究

目的:观察奥美沙坦酯和氨氯地平联合治疗控制血压的疗效和安全性。方法:70例2、3级高血压病患者随机接受奥美沙坦酯20 mg与氨氯地平5 mg联合治疗或缬沙坦80 mg与氨氯地平5 mg联合治疗,1次/d,总疗程8周。结果:奥美沙坦酯组和缬沙坦组治疗后血压下降幅度分别为(24.5±9.5/16.0±6.8)mm Hg(1 mm Hg=0.133 kPa)和(24.3±9.2/15.7±6.6)mm Hg,2组间差异无统计学意义(P>0.05)。奥美沙坦酯与氨氯地平和缬沙坦与氨氯地平联合治疗组降压总有效率分别为91.4%和88.6%,2组间差异无统计学意义(P>0.05)。2组不良反应发生率差异无统计学意义(P>0.05)。结论:2、3级高血压病治疗,奥美沙坦酯与氨氯地平和缬沙坦与氨氯地平联合治疗疗效和不良反应均类似。     

Prevention of stroke and myocardial infarction by amlodipine and Angiotensin receptor blockers: a quantitative overview

In the present quantitative overview of outcome trials, we investigated the efficacy of amlodipine or angiotensin receptor blockers in the prevention of stroke and myocardial infarction in patients with hypertension, coronary artery disease, or diabetic nephropathy. The analysis included 12 trials of 94 338 patients. The analysis of trials involving an amlodipine group showed that amlodipine provided more protection against stroke and myocardial infarction than other antihypertensive drugs, including angiotensin receptor blockers (-19%, P<0.0001 and -7%, P=0.03) and placebo (-37%, P=0.06 and -29%, P=0.04). The analysis of trials involving an angiotensin receptor blocker group showed contrasting results between trials versus amlodipine and trials versus other antihypertensive drugs for stroke (+19% versus -25%; P<0.0001) and myocardial infarction (+21% versus +1%; P=0.03). The results of 3 trials comparing an angiotensin receptor blocker with placebo were neutral (P> or =0.14). The within-trial between-group difference in achieved systolic pressure ranged from -1.1 to +4.7 mm Hg for trials involving an amlodipine group and from -2.8 to +4.0 mm Hg for trials involving an angiotensin receptor blocker group. The metaregression analysis correlating odds ratios with blood pressure differences showed a negative relationship (regression coefficients: -3% to -8%), which reached statistical significance (regression coefficient: -6%; P=0.01) for stroke in trials involving an amlodipine group. In conclusion, blood pressure differences largely accounted for cardiovascular outcome.     

Comparison of effects of nisoldipine-extended release and amlodipine in patients with systemic hypertension and chronic stable angina pectoris

The efficacy and safety of nisoldipine-extended release (ER) and amlodipine were compared in a 6-week multicenter, randomized, double-blind, double-dummy, parallel group, titration-to-effect trial in patients with stage 1 to 2 systemic hypertension (90 to 109 mm Hg diastolic blood pressure [BP]) and chronic stable angina pectoris. After a 3-week placebo run-in period, patients (n = 120) were randomly assigned to active treatment with either nisoldipine-ER (20 to 40 mg) or amlodipine (5 to 10 mg) once daily, titrated as necessary after 2 weeks to achieve diastolic BP <90 mm Hg. After 6 weeks, the mean reduction in systolic/diastolic BP from baseline was 15/13 mm Hg with nisoldipine-ER and 13/11 mm Hg with amlodipine (p = NS/p = NS). Both drugs resulted in similar BP responder rates (diastolic BP <90 mm Hg in 87% of patients who received nisoldipine-ER and 78% of patients on amlodipine, p = NS) and anti-ischemic responder rates (increasing exercise time >20% in 20% and 27%, respectively [p = NS], and increasing exercise time >60 seconds in 32% and 29% of patients, respectively [p = NS]. Also, after 6 weeks of active therapy, there was a similar mean increase in total exercise duration (23 seconds in the nisoldipine-ER group and 21 seconds in the amlodipine group, p = NS). Neither drug increased heart rate and both decreased frequency of anginal episodes. Adverse events were infrequent, and typically were vasodilator-related effects (including headache and peripheral edema) that occurred with somewhat higher incidence in the nisoldipine-ER group. Thus, nisoldipine-ER and amlodipine provided comparable antihypertensive and anti-ischemic efficacy, and both were generally well tolerated.     

缬沙坦联合氨氯地平或氢氯噻嗪对老年高血压患者血压变异性的影响

目的 比较缬沙坦联合氨氯地平或氢氯噻嗪对老年高血压患者血压变异性及一氧化氮、内皮素的影响.方法选取61例2、3级老年高血压患者,随机分为两组,分别给予缬沙坦+氨氯地平或缬沙坦+氢氯噻嗪行降压治疗,观察入选时、治疗第8周和第16周各种相关指示的变化.人选时检测血脂、空腹血糖、血尿酸,试验各个阶段监测24 h动态血压,检测血浆一氧化氮、内皮素水平.结果在患者入选时、治疗第8周和第16周三个时间点,缬沙坦+氨氯地平组和缬沙坦+氢氯噻嗪组24 h血压及白昼血压比较差异无统计学意义.治疗第16周,缬沙坦+氨氯地平组晨峰收缩压较缬沙坦+氢氯嚷嗪组明显降低[(22.6±8.8)mm Hg(1 mm Hg=0.133 kPa)比(26.3±13.7)mm Hg,P＜0.05];缬沙坦+氨氯地平组及缬沙坦+氢氯噻嗪组24 h收缩压变异性(SBPV)进行性降低[缬沙坦+氨氯地平组:(12.5±2.8)mm Hg比(10.2 ±2.2)mm Hg比(8.8±1.6)mm Hg,P＜0.01;缬沙坦±氢氯噻嗪组:(12.5±2.5)mmHg比(10.7±2.2)mm Hg比(9.6±2.0)mmHg,P＜0.01],缬沙坦+氨氯地平组及缬沙坦+氢氯噻嗪组白昼SBPV明显降低[缬沙坦+氨氯地平组:(12.2±3.0)mm Hg比(10.1±2.3)mm Hg比(8.4±1.9)mm Hg,P＜0.01;缬沙坦+氢氯噻嗪组:(11.8±2.7)mm Hg比(10.4±1.9)mm Hg比(9.6±2.2)mm Hg,P＜0.01],缬沙坦+氨氯地平组24 h舒张压变异性(DBPV)显著降低[(15.5±3.4)mm Hg比(13.0±3.5)mm Hg比(12.3±2.5)mm Hg,P＜0.01],缬沙坦+氢氯噻嗪组24 h DBPV无显著性变化;缬沙坦+氨氯地平组第16周白昼SBPV低于缬沙坦+氢氯噻嗪组[(8.4±1.9)mm Hg比(9.6 ±2.2)mm Hg,p＜0.05],缬沙坦+氨氯地平第8周、第16周的24 h DBPV、白昼DBPV低于缬沙坦+氢氯噻嗪组(P ＜0.01～0.05);缬沙坦+氨氯地平组一氧化氮进行性升高[(27.3±13.6)μmol/L比(47.2±16.3)μmol/L比(69.5±18.9)μmol/L,P＜0.01]、内皮素进行性降低[(45.3±8.0)ng/L比(37.4±3.9)ng/L比(34.2±4.4)ng/L,P＜0.01];缬沙坦+氢氯噻嗪组一氧化氮进行性升高[(33.5±13.9)μmol/L 比(49.7±21.9)μmol/L比(66.7 ±24.7)μmol/L,P＜0.01]、内皮素显著降低[(46.6±10.4)ng/L比(37.0±5.4)ng/L比(36.1±8.2)ng/L,P＜0.01].治疗第8周,缬沙坦+氨氯地平组收缩压变异性的降幅与一氧化氮的升幅有相关性(r =0.401,P=0.025).结论缬沙坦联合氨氯地平或氢氯噻嗪均能降低老年高血压患者血压变异性、改善血管内皮功能,缬沙坦联合氨氯地平可能更适合于老年高血压患者.     

Efficacy and safety of amlodipine/valsartan compared with amlodipine monotherapy in patients with stage 2 hypertension: a randomized,double-blind,multicenter study: the EX-EFFeCTS Study

Achieving blood pressure (BP) targets in stage 2 hypertension usually requires two or more drugs, which should be selected from different classes. This study compared the efficacy and tolerability of amlodipine/valsartan with amlodipine in patients with stage 2 hypertension. In this multicenter, randomized, double-blind, 8-week study, 646 patients with stage 2 hypertension (mean sitting systolic blood pressure [MSSBP] ≥160 mm Hg) received amlodipine/valsartan 5/160 mg or amlodipine 5 mg for 2 weeks, prior to being force-titrated to amlodipine/valsartan 10/160 mg or amlodipine 10 mg, respectively, for a further 6 weeks. Hydrochlorothiazide could be added at Week 4 if MSSBP was ≥130 mm Hg. At endpoint Week 4, reductions in MSSBP were significantly greater in patients receiving amlodipine/valsartan than in those receiving amlodipine (30.1 mm Hg vs. 23.5 mm Hg; P < .0001). Likewise, MSSBP reductions in patients with baseline MSSBP ≥180 mm Hg were also greater for amlodipine/valsartan at Week 4 (40.1 mm Hg vs. 31.7 mm Hg for amlodipine; P = .0018). Differences favoring amlodipine/valsartan were also seen for BP control. Amlodipine/valsartan was generally well tolerated. These findings support the rationale for combining agents with complementary mechanisms of action, such as amlodipine and valsartan, in the management of stage 2 hypertension.     

A randomized, placebo-controlled, double-blind comparison of amlodipine and atenolol in patients with essential hypertension.

The efficacy and safety of amlodipine (2.5 mg, 5 mg, or 10 mg) once daily was compared with atenolol (50 mg to 100 mg) once daily in patients with mild-to-moderate essential hypertension in a randomized, double-blind, parallel, placebo-controlled study. One hundred and twenty-five patients were randomly allocated at the end of a 4-week run-in placebo period to 8 weeks' double-blind treatment with amlodipine (n = 41), atenolol (n = 43), or placebo (n = 41). The mean changes from baseline in blood pressure 24 h postdose for amlodipine (mean daily dose 8.8 mg) were -12.8/-10.1 mm Hg for supine and -11.5/-9.8 mm Hg for standing blood pressure (P < .001). For atenolol (mean daily dose 83.7 mg) the changes were -11.3/-11.7 mm Hg for supine and -13.3/-12.3 mm Hg for standing blood pressure (P < .001). There were no statistically significant differences between treatments. The responder rates for amlodipine, atenolol, and placebo were 61.1%, 64.9%, and 11.1%, respectively. Determinations taken over the 24-h period at the final visit revealed that amlodipine and atenolol maintained the group mean supine blood pressure at or below 140/90 mm Hg throughout the period of observation; the corresponding time-effect curve for the placebo group was clearly in the hypertensive range. Heart rate was significantly lowered by atenolol only. Both amlodipine and atenolol were well-tolerated. Only one patient was withdrawn because of the development of peripheral edema, arthralgia, and fatigue after treatment with amlodipine. This study demonstrates that once-daily administration of amlodipine or atenolol to mild-to-moderate hypertensive patients was well-tolerated and provided adequate blood pressure control throughout the 24-h dosing interval.