Efficacy and tolerability of candesartan cilexetil/hydrochlorothiazide and amlodipine in patients with poorly controlled mild-to-moderate essential hypertension.

The antihypertensive efficacy and tolerability of combination therapy with candesartan cilexetil, 16 mg plus hydrochlorothiazide (CC/HCTZ), 12.5 mg was compared with that of amlodipine, in a multicentre, double-blind, randomised, parallel-group study in patients with mild-to-moderate essential hypertension inadequately controlled by monotherapy. After a two week run-in period on existing therapy, patients with a sitting diastolic blood pressure (DBP) of 90-110 mmHg and a sitting systolic blood pressure (SBP) 相似文献   

Evaluation of long-term efficacy and acceptability of indapamide SR in elderly hypertensive patients

OBJECTIVE: To assess the long-term antihypertensive efficacy and acceptability of indapamide SR 1.5 mg in elderly hypertensive patients (> or = 65 years). STUDY DESIGN: Open, 12-month, follow-up study of 444 patients, treated with indapamide SR, who were responders and/or achieved target BP levels following a 3-month, randomised, controlled, double-blind short-term comparison of indapamide SR versus hydrochlorothiazide 25 mg and amlodipine 5 mg. RESULTS: The long-term decrease in systolic blood pressure (SBP)/diastolic blood pressure (DBP) after 12 months follow-up with indapamide SR was -24.0/-13.1 mmHg from baseline (M0). The percentage of patients that achieved target BP levels (DBP < 95 mmHg, SBP < or = 160 mmHg) was 80.1% [84.3% for isolated systolic hypertension (ISH) subgroup], and the response rate (BP < 140/90 mmHg or decrease in supine diastolic BP > or = 10 mmHg or in supine systolic BP > or = 20 mmHg) 81.5%. Blood pressure (BP) remained stable throughout the 12 months follow-up period (M3-M15), whatever the previous treatment received during the 3-month, doubleblind period (M0-M3). Clinical and biological acceptability was good. A low occurrence of withdrawals (7.2%), was reported. CONCLUSION: Over the course of the long-term, 12-month follow-up study, indapamide SR was shown to be an effective and well tolerated antihypertensive therapy, even after a switch from amlodipine or hydrochlorothiazide, in patients aged 65 years-80 years with systolo-diastolic hypertension (SDH) or ISH.     

缓释型硝苯地平与氨氯地平的降压作用比较

目的：比较缓释型硝苯地平与氨氯地平的动态降压作用。方法：１７例中、轻度原发性高血压病人（男性８例，女性９例，年龄４３±ｓ６ａ）８例予缓释型硝苯地平２０ｍｇ，ｐｏ，ｑｄ，９例予氨氯地平５～１０ｍｇ，ｐｏ，ｑｄ，×４ｗｋ。服药前、后做２４ｈ动态血压测定及踏车运动激发试验（ｎ＝１６）。结果：２药均有效地降低２４ｈ平均血压，但降压谷／峰（Ｔ／Ｐ）比值，收缩压（ＳＢＰ）Ｔ／Ｐ比值缓释硝苯地平组高于氨氯地平组，分别为８７％与７４％；舒张压（ＤＢＰ）Ｔ／Ｐ比值氨氯地平组高于缓释硝苯地平组，分别为８１％与６２％；运动激发下，服氨氯地平后ＤＢＰ仍能显著下降（Ｐ＜０．０１）及心率减慢（Ｐ＜０．０５）。结论：氨氯地平降２４ｈＤＢＰ的平稳性及对运动的耐受性均较缓释硝苯地平好。     

Comparison of benazepril-amlodipine and captopril-thiazide combinations in the management of mild-to-moderate hypertension

OBJECTIVE: To compare the efficacy and tolerability of benazepril 10 mg + amlodipine 5 mg combination (BZ+AM) versus captopril 50 mg + hydrochlorothiazide 25 mg (CP+HT) combination. MATERIAL: 405 outpatients with mild-to-moderate arterial hypertension not adequately controlled by a monotherapy with ACE inhibitors or calcium channel blockers or diuretics entered this multicenter, double-blind, randomized, parallel-group study. METHOD: After a 2-week placebo run-in, 397 patients with sitting diastolic (D) blood pressure (BP) > 95 mmHg and/or sitting systolic (S) BP > 160 mmHg were randomized to receive either BZ+AM (201 patients) or CP+HT (196 patients) once daily for 12 weeks. Main outcome measure was sitting DBP and SBP values at the end of active treatment. The response rate was defined as the proportion of patients with either a final sitting DBP < 90 mmHg or decreased by at least 10 mmHg or a sitting SBP < 150 mmHg or decreased by at least 20 mmHg from baseline. RESULTS: The DBP and SBP values obtained with BZ+AM were, respectively, 2.7 and 3.7 mmHg lower than those obtained with CP+HT (both p < 0.001 vs. CP+HT). The response rate in the BZ+AM group (94.8%) was better than that observed in the CP+HT group (86.0%, p = 0.004). The incidence of adverse events was similar with the 2 treatment regimens (17.9% for both). CONCLUSIONS: These data suggest a higher antihypertensive efficacy of the fixed combination BZ 10 mg+AM 5 mg as compared with CP 50 mg+HT 25 mg.     

Comparison of monotherapy with irbesartan 150 mg or amlodipine 5 mg for treatment of mild-to-moderate hypertension.

OBJECTIVE. The primary objective of this study was to compare the antihypertensive efficacy of the angiotensin II receptor blocker irbesartan 150 mg and the calcium channel blocker amlodipine 5 mg in the treatment of patients with seated diastolic blood pressure (DBP) 95-110 mmHg. DESIGN. Multicentre, randomised, double-blind, comparative pilot study. METHODS. Subjects were 18-65 years of age, with DBP 95-110 mmHg, and of non-African American origin. Following a three week, single-blind, placebo lead-in period, 181 subjects were randomised in a 1:1 ratio to receive once-daily irbesartan 150 mg (n=89) or amlodipine 5 mg (n=92) for four weeks. Trough (24+/-3 hours post-dosing) BP measurements were obtained at baseline and at Weeks 2 and 4 under standardised, controlled conditions. Response was defined as DBP <90 mmHg or a reduction from baseline of 10 mmHg. RESULTS. After four weeks of treatment, the mean (+/-SE) decrease from baseline in DBP was 9.4+/-0.6 mmHg in the irbesartan group vs. 9.6+/-0.6 mmHg in the amlodipine group (p=0.806). The mean decrease from baseline in seated systolic BP was 12.2+/-1.0 mmHg in the irbesartan group vs. 12.0+/-1.0 mmHg in the amlodipine group (p=0.885). Overall, 62% of subjects in the irbesartan group and 63% in the amlodipine group had a response (p=0.609), and 54% and 56% of patients (p=0.596), respectively, had their DBP normalised (<90 mmHg). Adverse events were reported by 21.3% of patients receiving irbesartan and 20.7% receiving amlodipine. Conclusions. Irbesartan 150 mg demonstrated comparable efficacy to amlodipine 5 mg, thereby confirming its value as an antihypertensive treatment option in non-African American patients with DBP 95-110 mmHg.     

国产氨氯地平治疗慢性肾功能不全并高血压的临床观察

目的 评价国产氨氯地平(兰迪)治疗慢性肾功能不全合并轻中度高血压的降压疗效和安全性.方法 慢性肾功能不全(血清肌酐值265-442 μmol/L)合并高血压患者61例,随机分为两组:兰迪组(31例)、氨氯地平组(络活喜组,30例),分别服用兰迪或络活喜5 mg每日1次,治疗4周末坐位DBP＜80 mm Hg且SBP＜130 mm Hg者继续原剂量治疗至8周末;坐位DBP≥80 mm Hg或SBP≥130 mm Hg者剂量分别加倍至10 mg 每日1次治疗至8周末.分别观察患者服药前后血压、心率和肝肾功能等生化指标变化及其不良反应.结果 61例患者均完成8周的临床试验.降压总有效率兰迪组达87%,络活喜组达90%,若以血压为130/80 mm Hg为靶目标值则:兰迪组8周后11例(36%)达标;络活喜组9例(30%)达标.两组不良反应轻,试验结束时主要实验室检查指标与试验前比较差异无统计学意义.结论 国产氨氯地平(兰迪)5～10 mg,每日1次是治疗慢性肾功能不全合并轻中度肾性高血压有效药物之一,且安全性好.     

Relationship between the pharmacokinetic and pharmacodynamic profile of nilvadipine in the dog

The purpose of this study was to determine the pharmacokinetic profile of nilvadipine and, using a chronic dog model, determine whether there was a correlation between plasma concentrations of the drug and hemodynamic effects. Nilvadipine was given to four dogs as single intravenous (iv) and oral doses. Pharmacokinetic parameters were estimated after each dose using model-independent methods. The mean elimination half-life was approximately 6 hr after both iv and oral doses. The absolute bioavailability of nilvadipine decreased from 67 to 27% after increasing oral doses (6 and 24 mg), probably because of reduced drug absorption from the gastrointestinal tract. Nilvadipine produced plasma concentration-related decreases in diastolic (DBP) and systolic (SBP) blood pressure and reflex increases in heart rate. The maximum reduction in DBP and SBP ranged from 34 to 53% and 17 to 47%, respectively, from control and was attained at about 0.1 and 0.7 hr after iv and oral doses, respectively. A strong linear correlation between the per cent reduction in both DBP (r = 0.9; p less than 0.001) and SBP (r = 0.66; p less than 0.001) and log plasma concentration of nilvadipine was established. The slopes of the concentration-response relationships were virtually superimposable after both iv and oral routes of administration. A plasma concentration of about 10 and 16 ng/ml was associated with a 14% reduction in DBP or SBP, respectively. There was no clear relationship between plasma concentrations of nilvadipine and changes in heart rate.     

Efficacy and tolerability of rilmenidine compared with isradipine in hypertensive patients with features of metabolic syndrome

OBJECTIVES: A high prevalence of associated metabolic cardiovascular risk factors is often observed among hypertensive subjects. The aim of the present study was to assess the effects of 1-2 mg/day of rilmenidine, a centrally acting antihypertensive agent with selectivity for I(1) imidazoline receptors, vs. 2.5-5 mg/twice daily of isradipine, a dihydropyridine calcium channel blocker, in hypertensive patients with features of the metabolic syndrome. RESEARCH DESIGN AND METHODS: In this 6-month multicentre, comparative, double-blind, parallel group study, the primary objective was to assess the effects of the treatments on blood pressure (BP); the secondary endpoints were to assess glucose and lipid metabolism, in addition to clinical and biological tolerability. In non-responder patients, dose adjustment was possible from the first month and adding a diuretic from the third month. RESULTS: Of an intention-to-treat population of 93 patients, 84 per protocol patients completed the study: 42 in the rilmenidine group and 42 in the isradipine group. BP decreased significantly (p < 0.001) and similarly in both groups (systolic blood pressure, SBP: -16.0 +/- 17.2 mmHg and -15.0 +/- 13.0 mmHg, and diastolic blood pressure, DBP: -9.0 +/- 9.4 mmHg and -9.0 +/- 8.7 mmHg with rilmenidine and isradipine, respectively). Normalisation (DBP < 90 mmHg and SBP < 140 mmHg) and response (normalisation or decrease in SBP >or= 20 mmHg or decrease in DBP >or= 10 mmHg) rates were respectively 57% and 72% with rilmenidine and 64% and 79% with isradipine (NS between groups). The effects of the treatments on both glucose and lipid metabolism were comparable: no significant difference from baseline was observed on the main parameters including insulin sensitivity indexes. The two treatments appeared to be well tolerated throughout the study, with no serious adverse reaction reported in the rilmenidine group and one serious adverse event in the isradipine group (a perimalleolar oedema), leading to withdrawal from the study for the affected patient. CONCLUSION: This study suggests that in hypertensive patients with metabolic disorders, rilmenidine is an effective antihypertensive treatment, comparable to isradipine, with metabolic neutrality and a good tolerance profile.     

依那普利-氢氯噻嗪治疗原发性高血压的临床疗效

目的:研究依那普利-氢氯噻嗪治疗中国人原发性高血压的临床疗效、安全性和耐受性。方法:采用随机、双盲、平行对照临床试验。126例轻、中度原发性高血压[95mmHg≤平均坐位舒张压(DBP)<110mmHg,平均坐位收缩压(SBP)<180mmHg(1mmHg=0.133kPa)],口服安慰剂2wk后, DBP仍在95-110mmHg的病人,随机分为3组,A组口服依那普利-氢氯噻嗪(10mg:6.25mg),qd;B组口服依那普利-氢氯噻嗪(10mg:12.5mg),qd;C组口服依那普利10mg,qd,4wk后如DBP≥90mmHg,各组剂量均加倍,疗程为8wk。安慰剂期末和治疗2,4,6,8wk测量坐位、立位血压和心率,记录不良反应。结果:8wk末,A组DBP由(99±4)mmHg降至(83±6)mmHg,降低(15±4)mmHg, SBP降低(18±14)mmHg;B组DBP由(100±5)mmHg降至(83±6)mmHg,降低(16±7)mmHg, SBP降低(17±16)mmHg;C组DBP由(97.0±2.0)mmHg降至(89±8)mmHg,降低(8±8)mmHg, SBP降低(3±14)mmHg。各组内DBP与治疗前相比均有非常显著差异(P<0.01),A,B两组组间差异无显著意义(P>0.05),A,B两组降压幅度优于C组,组间比较差异显著(P<0.05)。A,B,C组降压总有效率分别为86％,83％及60％,A,B两组比较无显著差异,分别与C组比较差异显著,优于C组(P<0.05)。3组主要不良反应为咳嗽、干咳,组间比较发生率无显著差异。结论:依那普利-氢氯噻嗪治疗轻、中度原发性高血压疗效优于单药制剂,6.25mg与12.5mg氢氯噻嗪的复方制剂降压疗效相似,复方制剂和单药一样安全,且耐受性好。     

氨氯地平为基础的不同用药方案治疗原发性高血压的疗效观察

目的:探讨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,入选原发性高血压患者180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周,观察血压、降压达标率、有效率、不良反应,检测脉搏波速度(Pulse wave velocitv PWV)、生化指标结果:治疗12周后,阿米洛利组和替米沙坦组之间收缩压和舒张压下降幅度差异无统计学意义(P＞0.05).两组降压达标率、有效率和不良反应率之间差异无统计学意义(P＞0.05).治疗前后两组患者双侧PWV均明显下降(P＜0.05).治疗后替米沙坦组尿酸水平明显下降(P＜0.05).结论:氨氯地平联合复方阿米洛利或替米沙坦均能显著降低原发性高血压患者血压,耐受性好,不良反应少.两组均能有效改善患者动脉僵硬程度,替米沙坦组能更好的降低患者尿酸水平.     

平压汤联合苯磺酸氨氯地平疗老年高血压患者的疗效研究

目的 探讨平压汤联合苯磺酸氨氯地平治疗老年高血压患者的疗效.方法 选取从2014年4月至2015年4月来本院就诊且确诊为高血压的老年患者共130例,根据随机数字表法分成对照组和研究组,每组65例,对照组患者仅使用苯磺酸氨氯地平进行治疗,研究组患者使用本院自拟平压汤联合苯磺酸氨氯地平联合治疗.连续用药12周,观察两组患者血压和不良反应情况,进行统计分析.结果 通过治疗后,对照组患者的总有效率为83.1％,研究组患者的总有效率为96.9％,明显高于对照组(P＜0.05);对照组患者的收缩压为(127.6±9.2) mmHg(1 mmHg=0.133 kPa),舒张压为(100.1±5.1) mmHg,研究组患者的收缩压为(110.1±9.1) mmHg,舒张压为(90.3±4.2) mmHg,两组患者的血压与治疗前相比均明显下降,研究组改善的更为明显,与对照组比较,差异有统计学意义(P＜0.05);两组患者的不良反应发生率比较,差异无统计学意义(P＞0.05).结论 使用平压汤联合苯磺酸氨氯地平治疗老年高血压具有良好的效果,且不良反应较少,有较高的安全性.     

依普罗沙坦与氯沙坦在轻中度原发性高血压病人中的降压疗效比较

目的:以氯沙坦为对照,观察依普罗沙坦治疗轻、中度原发性高血压(EH)病人的疗效与安全性。方法:采用前瞻性、随机、双盲、阳性药对照研究。符合方案的50例轻、中度EH病人经筛选期(2 wk)、安慰剂导入期(2 wk)后,随机分为依普罗沙坦组(n=24)与氯沙坦组(n=26)。在治疗期,2组病人分别每日1次口服依普罗沙坦600 mg或氯沙坦50 mg。若4 wk血压不达标,即坐位舒张压(DBP)≥90 mmHg (1 mmHg=0．133 3 kPa),加氢氯噻嗪12．5 mg,每日1次口服至8 wk。观察治疗前、治疗后4 wk与8 wk血压、心率以及治疗前后血、尿常规,血生化及心电图改变。结果:在治疗后8 wk,依普罗沙坦组的收缩压(SBP)与DBP分别下降了(12±s 10)mmHg与(12±5)mmHg,氯沙坦组的降压幅度分别为(14±9)mmHg与(10±6)mmHg,治疗前后比较有非常显著差异(P<0．01);但2组间血压下降的幅度无显著差异(P>0．05)。依普罗沙坦组与氯沙坦组的降压总有效率分别为100％和8l％,2组疗效无显著差异(P>0．05)。依普罗沙坦组加用氢氯噻嗪病例为9例(38％),而氯沙坦组为6例(23％),p> 0．05。2组心率及血液生化检查结果,治疗前后变化均无显著意义(P>0．05),均无严重不良反应发生。结论:依普罗沙坦与氯沙坦均能有效降低轻、中度EH病人的血压,疗效相似,都具有良好的安全性。     

降压药在老年高血压患者中的临床药学探析

目的：分析老年高血压患者降压药的临床应用情况,为临床工作提供借鉴。方法800例高血压患者的基本资料进行记录,包括患者的身高、体重、血压以及使用的降压药物等;记录患者的血压控制情况,观察不良反应,整理并回顾性分析。结果35.5%的患者使用缬沙坦,21.0%的患者使用氨氯地平;舒张压得到控制的患者占70.0%,收缩压得到控制的患者占51.0%;主要不良反应有踝部水肿、心动过缓、低钾血症、体位性低血压、干咳等。结论老年高血压患者,使用较多的药物为缬沙坦和氨氯地平,舒张压的控制比率要高于收缩压,同时,虽然有部分患者出现不良反应,但是降压药的使用基本符合规范。     

阿罗洛尔与氨氯地平治疗糖尿病高血压的随机对照研究

目的验证阿罗洛尔在治疗糖尿病合并高血压病人应用中临床有效性和安全性。方法18～75 a的糖尿病合并高血压者83例,随机分为阿罗洛尔组(n=41)和氨氯地平组(n=42),分别服用阿罗洛尔(5～15 mg,bid)或氨氯地平(5～10 mg,qd),观察12 wk。每4 wk随访一次,观察血压、空腹血糖,用药前后测定糖化血红蛋白(HbA1c)及各项安全性指标。结果治疗后,2组血压都明显下降,组间无明显差异(P>0.05)。高血压治疗前后,2组的空腹血糖及HhA1c均无统计学差异(P>0.05)。治疗12 wk后,阿罗洛尔组心率由(78±6)次·min~(-1)下降至(69±9)次·min~(-1),与氨氯地平组相比有统计学差异。阿罗洛尔组总有效率为85%,氨氯地平组为93%,无统计学差异(P>0.05)。结论阿罗洛尔能有效地降低糖尿病合并高血压痛病人的收缩压和舒张压,对糖代谢及脂代谢无不良影响,对糖尿病合并的高血压病人,尤其是对伴有交感神经兴奋者是一个安全有效的降压药物。     

不同体位心脏手术术后搬运对血流动力学的影响

目的探讨两种体位即平卧位和侧卧位心脏手术术后搬运对血流动力学的影响。方法选择2012年1月至12月心脏手术患者100例,按手术不同体位分为侧卧位组42例和平卧位组58例。分别对患者术后搬运前与搬运后的心率（HR）、收缩压（SBP）、舒张压（DBP）、中心静脉压（CVP）的变化分别记录并进行分析比较。结果平卧位患者搬运前后HR、SBP、DBP和CVP比较差异有统计学意义（P〈0．05）;侧卧位患者搬运前后HR、SBP、DBP和CVP比较差异有统计学意义（P〈0．05）;侧卧位组患者术后搬运前后的HR、SBP、DBP和CVP的变化差值分别为：（7．75±0．58）次／min,（-17．78±2．22）mmHg,（-13．25±1．12）mmHg,（-1．3±0．26）cmH20;平卧位组患者术后搬运前后的HR、SBP、DBP和CVP变化差值分别为：（7．15±0．63）次／min,（-13．23±1．78）mmHg,（-11．02±0．98）mmHg,（-0．9±0．23）cmH2O;两组患者搬运前后HR、SBP、DBP和CVP的变化差值比较差异有统计学意义（P〈0．05）。结论术后搬运会对心脏手术患者血流动力学造成一定的影响,可导致患者血压和心率的波动;侧卧位心脏手术患者术后搬运血流动力学变化较平卧位明显。     

Optimization of blood pressure treatment with fixed-combination perindopril/amlodipine in patients with arterial hypertension

Background: Fixed-dose combination treatments using an angiotensin-converting enzyme (ACE) inhibitor, such as perindopril, plus a calcium channel blocker (CCB), such as amlodipine, have been endorsed by guidelines because they improve blood pressure control and cardiovascular outcomes in hypertensive patients, while being well tolerated and well adhered to by patients. Objective: This study aimed to assess the blood pressure-lowering effects of fixed-combination perindopril/amlodipine in patients previously treated with an ACE inhibitor and/or a CCB. Methods: This was a prospective, real-life, open-label, longitudinal, phase IV study conducted in 223 outpatient medical centres across Slovakia. 2132 previously treated patients whose hypertension was insufficiently controlled at baseline or who tolerated treatment poorly were included. Patients were treated for 3 months with fixed-combination perindopril/amlodipine 5?mg/5?mg, 5?mg/10?mg, 10?mg/5?mg and 10?mg/10?mg. The main outcome measure was a reduction in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) and achievement of blood pressure targets (SBP/DBP <140/90?mmHg or <130/80?mmHg for patients with type 2 diabetes mellitus or high cardiovascular risk). Results: After 3 months of treatment, mean?±?SD SBP/DBP had decreased from 158.5?±?17.5/93.6?±?9.8?mmHg to 132.9?±?10.6/80.7?±?6.2?mmHg (p?相似文献   

A comparison of amlodipine with enalapril in the treatment of isolated systolic hypertension.

1. The safety and efficacy of amlodipine and enalapril were compared in patients with isolated systolic hypertension (supine DBP < 95 mm Hg and supine SBP 160-200 mm Hg). 2. After 2 weeks treatment with placebo 31 patients were randomised by the technique of minimisation in an observer-blind study to receive once daily treatment with either amlodipine (16 patients) or enalapril (15 patients) for 8 weeks. The study design concluded with 2 weeks placebo treatment. In addition to clinic measurements, home blood pressure monitoring (Copal UA-251) was performed during the study. 3. Mean supine systolic blood pressure was reduced from 185 to 164 mm Hg (amlodipine) and 183 to 159 mm Hg (enalapril) (95% CI for the difference between the drugs -10.5, 15.3) after 8 weeks treatment. 4. Mean supine diastolic blood pressure was reduced from 86 to 80 mm Hg (amlodipine) and 88 to 80 mm Hg (enalapril) (95% CI for the difference between the drugs -4.9, 7.6) after 8 weeks treatment. 5. Home blood pressure recordings confirmed these reductions in blood pressure, although there was no significant difference between treatments for the reductions in blood pressure. 6. Both drugs were reasonably well tolerated. The adverse events occurring most frequently in the amlodipine group were headache (2), peripheral oedema (5) and palpitations (2). The adverse events occurring most frequently in the enalapril group were headache (2), peripheral oedema (2), palpitations (2) and dizziness (3).     

A comparison of amlodipine with enalapril in the treatment of moderate/severe hypertension.

1. The safety and efficacy of amlodipine vs enalapril as monotherapy was evaluated in patients with moderate/severe hypertension (supine DBP 105-125 mm Hg, SBP 140-220 mm Hg). 2. After 2 weeks placebo treatment 31 patients were randomised by the technique of minimisation in an observer-blind study to receive once daily treatment with either amlodipine (15 patients) 5-10 mg, or enalapril (16 patients) 5-20 mg for 8 weeks. The study design concluded with 2 weeks placebo treatment. In addition to clinic measurements, home blood pressure monitoring (Copal UA-251) was performed during the study. 3. Clinic supine systolic blood pressure was reduced from 177 to 152 mm Hg (amlodipine) and 183 to 169 mm Hg (enalapril) (95% CI for the intergroup difference -22.1, 0.3, P = 0.06) after 8 weeks treatment. 4. Clinic supine diastolic blood pressure was reduced from 110 to 93 mm Hg (amlodipine) and 109-102 mm Hg (enalapril) (95% CI for the intergroup difference -17.7, -2.7, P < 0.01) after 8 weeks treatment. 5. Home blood pressure recordings confirmed these reductions in blood pressure. Although the reduction in blood pressure was greater for the amlodipine treated group, the differences between treatments were not statistically significant. 6. Both drugs were reasonably well tolerated. The adverse events occurring most frequently in the amlodipine group were headache (5), peripheral oedema (3), upper respiratory infection (3) and anxiety (2). The adverse events occurring most frequently in the enalapril treated patients were headache (6), dizziness (3) and upper respiratory infection (2).     

Bisoprolol/amlodipine combination therapy improves blood pressure control in patients with essential hypertension following monotherapy failure

Objective: The efficacy of a bisoprolol/amlodipine fixed-dose combination (FDC) in patients with essential hypertension who had not responded to bisoprolol or amlodipine monotherapy was investigated.

Research design and methods: In an 18 week, multicenter, randomized, comparative phase III study (ClinicalTrials.gov identifier: NCT01977794), patients with blood pressure uncontrolled by bisoprolol or amlodipine monotherapy (5?mg OD) began treatment with bisoprolol/amlodipine FDC 5/5?mg OD. Patients with controlled blood pressure (BP) at week 6/12 continued at current FDC strength, and patients with uncontrolled BP received FDC dose uptitration (maximum dose: 10/10?mg). The primary efficacy endpoint was change in systolic blood pressure (SBP) at week 18 versus baseline (corresponding to SBP under monotherapy), and secondary endpoints included change from baseline in SBP after week 6/12 and percentage of BP-controlled patients at week 6, 12 and 18. Safety was assessed by number/types of adverse events (AEs).

Results: Two hundred patients were randomized to treatment (100 with uncontrolled BP under bisoprolol and 100 under amlodipine monotherapy). Overall, 196 patients were eligible for analysis. The patient groups displayed similar mean SBP reductions from baseline by study end (bisoprolol monotherapy failure: 25.9?±?12.82?mmHg reduction; amlodipine monotherapy failure: 24.7?±?11.67?mmHg reduction; p?<?0.001 for both). Overall mean SBP decreased by 25.3?±?12.25?mmHg (p?<?0.001). Mean heart rate reductions were also observed (bisoprolol monotherapy failure: 6.6?±?9.67 bpm reduction; amlodipine monotherapy failure: 11.5?±?8.65 bpm reduction; p?<?0.001 for both). Most patients (83.2%) displayed BP control with bisoprolol/amlodipine 5/5?mg at 6 weeks. Treatment was well tolerated at all dose levels; treatment-related AEs (mostly of mild/moderate intensity) were reported by 52.5% of patients, with no severe or serious treatment-related AEs reported. As the study focused on hypertension, total cardiovascular risk was not assessed.

Conclusions: Bisoprolol/amlodipine FDC therapy is associated with significant BP improvements in patients with essential hypertension following monotherapy failure.     

Efficacy and Safety of Olmesartan Medoxomil and Hydrochlorothiazide Compared with Benazepril and Amlodipine Besylate

BACKGROUND: Most patients with stage 2 hypertension require two or more antihypertensive agents in order to achieve the BP goals recommended in current treatment guidelines. Accordingly, combinations of two drugs with different mechanisms of antihypertensive action are widely used. OBJECTIVE: The aim of this randomized, double-blind, multicenter 12-week study was to compare the efficacy, safety, and tolerability of a combination of olmesartan medoxomil/hydrochlorothiazide (HCTZ) with that of benazepril plus amlodipine besylate in patients with stage 2 hypertension. METHODS: Patients were eligible for randomization following a 3- to 4-week placebo run-in period if they had either (i) mean seated DBP>or=90 mm Hg but<115 mm Hg and mean seated SBP>or=160 mm Hg but <200 mm Hg, or (ii) mean seated DBP>or=100 mm Hg but<115 mm Hg. The difference in mean seated SBP measured on two separate visits during the run-in period was required to beor=95 mm Hg and<115 mm Hg or SBP>145 mm Hg and相似文献