缬沙坦/氢氯噻嗪复方制剂和缬沙坦降压疗效的比较

目的:对比缬沙坦/氢氯噻嗪(缬沙坦80mg/氢氯噻嗪12.5mg)复方制剂与缬沙坦(缬沙坦80mg)治疗轻、中度原发性高血压的谷峰比值(TPR)和平滑指数(SI),评价缬沙坦/氢氯噻嗪的降压疗效。方法:选择轻、中度原发性高血压病患者[SBP≥140mmHg且<160mmHg(1mmHg=0.133kPa),DBP≥95mmHg并且<110mmHg]84例,随机分为缬沙坦/氢氯噻嗪和缬沙坦组,共服药8周,观察服药前后血压及生化指标的变化。结果:治疗8周后,缬沙坦/氢氯噻嗪组和缬沙坦组降压有效率分别为84.2、52.5,达标率分别为73.9、42.9,两组间差异有统计学意义(P<0.001)。缬沙坦/氢氯噻嗪组TPR为SBP76.7、DBP71.2,均>50;SI为SBP1.14±0.39、DBP1.09±0.27,均>1。缬沙坦组的TPR为SBP77.6、DBP71.3,均>50;SI为SBP1.24±0.39、DBP1.19±0.27,均>1。两组的TPR和SI差别无统计学意义(P>0.05)。结论:缬沙坦80mg/氢氯噻嗪12.5mg复方制剂治疗轻中度原发性高血压患者疗效优于单用缬沙坦80mg,TPR和SI...     

缬沙坦-氢氯噻嗪合用治疗高血压早期肾损害的疗效

目的：评价缬沙坦．氢氯噻嗪合用治疗原发性高血压早期肾损害的有效性和安全性。方法：选择64例原发性高血压合并血、尿132微球蛋白增高的患者,采用单盲法随机分成2组：缬沙坦-氢氯噻嗪组32例,服用缬沙坦80mg、氢氯噻嗪12．5mg每日一次;缬沙坦组32例,服用缬沙坦80mg,每日一次,疗程为2个月。治疗前后分别检测患者静态血压和动态血压、血尿素氮、血肌酐、尿α1,微球蛋白、血和尿β2微球蛋白、尿微量白蛋白,比较治疗前后的变化。结果：单用缬沙坦或缬沙坦．氢氯噻嗪合用后,患者SBP、DBP均显著下降,缬沙坦-氢氯噻嗪组降压幅度比缬沙坦组显著（P〈0．01）;两组治疗后血和尿β2-微球蛋白、尿微量白蛋白含量均显著下降（P〈0．01）,缬沙坦-氢氯噻嗪组较缬沙坦组下降更显著（P〈0．01）;两组血肌酐、血尿素氮、尿α1微球蛋白较治疗前也均有下降（P〈0．05）。结论：缬沙坦-氢氯噻嗪合用与缬沙坦单用均能有效降低血压、血和尿β2-微球蛋白、尿微量白蛋白含量,对高血压患者早期肾功能损害有一定保护作用,合用效果优于单用。     

单片复方制剂缬沙坦/氨氯地平治疗老年晨峰高血压的临床研究

目的对比观察两种单片复方制剂缬沙坦/氨氯地平（倍博特）与缬沙坦/氢氯噻嗪（复代文）治疗老年晨峰高血压的疗效,为临床提供指导和帮助。方法选择90例治疗或未经治疗的老年原发性高血压患者,全部给予缬沙坦单药80 mg,每天1次,治疗4周后其中58例经动态血压监测具有晨峰血压现象（MBPS）者随机分为两组,观察组换用药物倍博特（n=29）,对照组换用药物复代文（n=29）,每天1次,观察换药治疗4周后24 h平均收缩压（SBP）、24 h平均舒张压（DBP）、24 h平均血压达标率、晨峰血压控制率。结果与换药治疗前比较,2组换药治疗4周后24 h平均SBP和DBP均下降（P〈0.05）,观察组下降幅度大于对照组（P〈0.05）;观察组24 h血压达标率、晨峰血压控制率均高于对照组（P〈0.05）。结论缬沙坦/氨氯地平或缬沙坦/氢氯噻嗪均能有效控制老年原发性高血压患者的血压,但缬沙坦/氨氯地平具有更高的血压达标率及晨峰血压控制率,更适合老年高血压病患者。     

比索洛尔/氢氯噻嗪复方片治疗原发性高血压的疗效与安全性

目的 评价比索洛尔/氢氯噻嗪复方片治疗轻中度原发性高血压的临床疗效与安全性。方法采用随机、双盲、平行对照的方法，选择轻中度原发性高血压患者 31 例，经2周安慰药洗脱后，随机分为试验组16例和对照组15 例。试验组给予比索洛尔/氢氯噻嗪复方片（2.5 mg/6.25 mg）口服，对照组给予比索洛尔片2.5 mg口服，均每天1次。治疗4周末若坐位舒张压仍≥90 mmHg（1 mmHg＝0.133 kPa），则剂量分别加至比索洛尔/氢氯噻嗪复方片5 mg/6.25 mg或比索洛尔片5 mg，qd，治疗至8周末。于安慰药洗脱末及治疗2，4，6，8周末测量诊室血压、心率、体征并记录不良反应。试验开始前及结束时进行实验室及心电图检查。结果共29例患者完成试验，其中试验组16例，对照组13例。两组服药后4周末和8周末坐位收缩压、舒张压及心率与服药前比较均明显降低(均P＜0.01)；试验组坐位舒张压下降幅度较对照组大(P＜0.05)；试验组8周末坐位收缩压下降幅度较对照组大(P＜0.05)。服药8 周后，试验组总有效率（93.75%）明显高于对照组（53.33%）（P＜0.05）。两组不良反应均较轻而少，组间比较差异无显著性。两组治疗前后实验室检查指标异常率差异无显著性。结论每天一次给予比索洛尔/氢氯噻嗪复方片2.5～5.0 mg/6.25 mg治疗轻、中度原发性高血压的疗效优于单药比索洛尔，且安全性好。     

氯沙坦钾氢氯噻嗪片治疗老年原发性高血压的临床效果观察

目的分析老年原发性高血压患者应用氯沙坦钾氢氯噻嗪片治疗的效果。方法 96例老年原发性高血压患者,随机分为对照组和观察组,每组48例。对照组采用氢氯噻嗪片治疗,观察组采用氯沙坦钾氢氯噻嗪片治疗。比较两组患者治疗效果及治疗前后血压水平。结果观察组患者的治疗总有效率97.92%高于对照组的85.42%,差异具有统计学意义(P<0.05)。治疗前,两组患者的清晨收缩压(SBP)、舒张压(DBP)及24 h动态SBP、DBP水平比较差异无统计学意义(P>0.05);治疗后,两组患者的清晨SBP、DBP及24 h动态SBP、DBP水平均较治疗前降低,且观察组患者的清晨SBP(135.14±7.04)mm Hg(1 mm Hg=0.133 kPa)、DBP(86.53±6.78)mm Hg及24 h动态SBP(134.24±9.61)mm Hg、DBP(84.81±8.80)mm Hg低于对照组的(140.26±8.17)、(92.06±7.36)、(142.36±9.16)、(89.03±8.05)mm Hg,差异具有统计学意义(P<0.05)。结论老年原发性高血压患者应用氯沙坦钾氢氯噻嗪片治疗的效果比较好,可以明显改善血压水平,具有较高的应用价值。     

缬沙坦与氢氯噻嗪治疗轻、中度原发性高血压的临床观察

目的了解缬沙坦/氢氯噻嗪联用与缬沙坦单剂治疗轻、中度原发性高血压(90mmHg(?)坐位舒张压<110mmHg)的疗效。方法共入选102例轻、中度原发性高血压。随机分为两组:治疗组52例,对照组50例。治疗组给予缬沙坦80mg片剂,1次/d,早晨顿服;同时联用氢氯噻嗪12.5mg,2次/d;对照组给予缬沙坦80mg片剂,1次/d;如果4周末时血压控制不满意(舒张压(?) 85mmHg),随后4周的剂量将被分别增加至缬沙坦160mg/氢氯噻嗪12.5mg或缬沙坦160mg。结果治疗8周以后,治疗组与对照组的坐位收缩压分别下降了23.6±11.4mmHg和16.4±10.2mmHg,P<0.001:坐位舒张压下降的幅度分别为15.0±8.4mmHg和10.4±7.8mmHg,P<0.001;治疗组与对照组降低血压的总有效率分别为98.0%和90%;两组比较显效率差异有显著性(P<0.05)。结论治疗组与对照组相比,缬沙坦与氢氯噻嗪联用治疗高血压病疗效显著。     

缬沙坦联合氢氯噻嗪对高血压患者24h DBP、24h SBP水平的影响

目的 探讨缬沙坦联合氢氯噻嗪对高血压患者24 h舒张压(DBP)和24 h收缩压(SBP)的影响.方法 85例高血压患者,按照随机数字表法分为对照组(42例)和观察组(43例).对照组患者给予缬沙坦治疗,观察组患者在对照组基础上联合氢氯噻嗪治疗.对比两组患者临床疗效、不良反应发生情况及治疗前后24 h DBP、24 h...     

阿托伐他汀和缬沙坦联合治疗对老年高血压患者左心室肥厚的逆转

目的:探讨阿托伐他汀和缬沙坦联合治疗对老年原发性高血压(EH)患者左心室肥厚(LVH)的逆转。方法:将135例伴LVH的老年EH患者随机分成缬沙坦组和缬沙坦加阿托伐他汀治疗组,设定血压达标值为收缩压(SBP)<140mmHg(1mmHg=0.133kPa)和舒张压(DBP)<90mmHg。2组患者分别口服起始剂量缬沙坦80mg/d和阿托伐他汀20mg/d加缬沙坦8Omg/d。随访周期为2周,若血压未能达标,则增加缬沙坦剂量至160mg/d。2组患者均口服氢氯噻嗪25mg/d。总疗程24周。检测治疗前后24h动态血压、左室质量指数(LVMI)。结果:2组治疗后LVMI分别较治疗前显著性降低(均P<0.01)。缬沙坦和阿托伐他汀治疗组治疗前后LVMI的降低幅度大于单独缬沙坦治疗组,差别均具有统计学意义(P<0.05)。结论:阿托伐他汀加缬沙坦联合治疗在逆转LVH和抑制心脏交感活性方面较缬沙坦单药治疗具有更加显著的作用,且这些作用独立于降压疗效之外。     

不同降压药物联合治疗对老年高血压患者血压变异性的影响

摘要： 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的治疗作用。方法 80 例老年高血压患者随机分为 2 组, 分别给予缬沙坦联合氨氯地平 （氨氯地平组） 或缬沙坦联合氢氯噻嗪 （氢氯噻嗪组） 降压治疗, 监测 2 组 24 h 动态血压, 观察治疗前、 治疗第 6 周和第 12 周, 2 组血压及血压变异性的变化。同时观察 2 组 6 周末血压达标率。记录治疗过程中的不良反应情况。结果 2 组治疗 6 周和 12 周的 24 h 平均收缩压 （SBP）、白昼 SBP、 夜间 SBP、 晨峰 SBP、 24 h 收缩压变异性 （SBPV） 均较治疗前降低 （P < 0.05）。24 h SBP、 白昼 SBP、 夜间 SBP、 24 h SBPV 及白昼 SBPV 分组因素与时间因素存在交互作用 （P < 0.05）。治疗第 6 周和第 12 周, 氨氯地平组 24 h SBP、 白昼 SBP、 夜间 SBP 及白昼 SBPV 较氢氯噻嗪组降低 （P < 0.05）, 治疗第 12 周, 氨氯地平组 24 h SBPV 低于氢氯噻嗪组 （P < 0.01）。2 组血压达标率和不良反应发生率差异均无统计学意义。结论 缬沙坦联合氨氯地平或氢氯噻嗪均能有效控制老年高血压患者血压变异性, 而缬沙坦联合氨氯地平在降低血压和血压变异性方面作用更强。     

高龄患者高血压晨峰现象的药物治疗

目的:探讨缬沙坦联合富马酸比索洛尔对高龄轻、中度高血压患者血压晨峰现象的影响。方法:选择60例高龄轻中度高血压伴晨峰现象的患者随机分为两组各30例,干预组予以缬沙坦80 mg/d晨起口服+富马酸比索洛尔5mg/d睡前口服,对照组予以苯磺酸左旋氨氯地平5 mg/d晨起口服。观察两组患者降压效果及治疗前后晨起后2 h SBP、DBP和晨峰SBP的差异。结果:两组所有患者无严重不良反应发生。服药后6周时两组降压达标率无统计学差异(P>0.05)。两组晨起后2 h SBP、DBP比较,服药后2周时无统计学差异(P>0.05),服药后4周、6周时有统计学无差异(P<0.05)。两组晨峰SBP比较,服药后2周时无统计学差异(P>0.05),服药后4周、6周时有统计学无差异(P<0.05)。结论:缬沙坦联合富马酸比索洛尔能够有效地控制高龄高血压患者血压晨峰现象,降压效果确切,且安全性良好。     

比索洛尔治疗原发性高血压患者的疗效观察

目的：评价比索洛尔治疗原发性高血压患者诊室血压的安全性和疗效。方法：36例初诊的轻、中度原发性高血压患者接受比索洛尔治疗4周，检测治疗前后诊室血压、动态血压及生化指标的变化，并设有安慰剂对照组36例。结果：比索洛尔组显效10例，有效14例；对照组显效4例，有效10例，2组疗效差异有统计学意义（P〈0．05）。诊室血压、心率、24h血压、白天血压、夜间血压、最大血压和最小舒张压均有降低（P〈0．05），收缩压与舒张压的谷／峰比值分别为53％和69％。治疗前后生化指标变化差别无统计学意义。结论：比索洛尔是治疗原发性高血压安全有效的药物．对糖、脂代谢无明显影响。     

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   

Safety and antihypertensive efficacy of carvedilol and atenolol alone and in combination with hydrochlorothiazide

Carvedilol has been shown to be effective and safe in patients with essential hypertension when given as monotherapy. In this double-blind, randomized, group-comparative study, 2 groups of 59 patients with mild to moderate essential hypertension [median supine systolic/diastolic blood pressure at baseline (SBP/DBP), 168/105 mm Hg] were treated with either 25 mg carvedilol once daily (o. d.) or 50 mg atenolol o. d. for 4 weeks. Responders at 4 weeks (DBP, < 90=" mmhg)=" terminated=" the=" study.=" nonresponders=" continued=" the=" study.=" hydrochlorothiazide=" (hctz)=" was=" added=" at=" 25=" mg=" o.=" d.=" for=" a=" further=" 6=" weeks.=" the=" median=" blood=" pressure=" decreased=" under=" monotherapy=" with=" carvedilol=">n = 59) from 167/105 at baseline to 155/94 mmHg after 4 weeks, and in the atenolol group (n=59) it decreased from 168/105 to 162/97 mmHg. The patients who received carvedilol in combination with HCTZ and were evaluated for efficacy (n = 38) showed a decrease in SBP/DBP from 156/97 at the end of monotherapy to 145/88 mmHg after 10 weeks; the combination of atenolol with HCTZ (n = 44) reduced BP from 162/97 to 147/88. Both carvedilol and atenolol were safe when given either alone or in combination with HCTZ. In conclusion, after long-term administration, 25 mg carvedilol o. d. and 50 mg atenolol o. d. significantly reduced both SBP and DBP over 24 h. The addition of HCTZ led to a further increase in antihypertensive efficacy. Combined treatment with carvedilol or atenolol and HCTZ was very well tolerated, without hypotensive events or relevant changes in objective safety parameters.     

Valsartan, a new angiotensin II antagonist for the treatment of essential hypertension: efficacy and safety compared to hydrochlorothiazide

Objective: To compare the antihypertensive efficacy of a new angiotensin II antagonist, valsartan, with a reference therapy, hydrochlorothiazide (HCTZ). Methods: In this double-blind study, 167 adult outpatients with mild-to-moderate essential hypertension were randomly allocated in equal number to receive valsartan 80 mg or HCTZ 25 mg for 12 weeks. In patients whose blood pressure (BP) remained uncontrolled after 8 weeks of monotherapy, atenolol 50 mg was added to the initial treatment. Patients were assessed at 4, 8 and 12 weeks. The primary efficacy variable was change from baseline in mean sitting diastolic BP (SDBP) at 8 weeks. Secondary variables included change in sitting systolic BP (SSBP) and responder rates (percentage of patients with SDBP <90 mmHg or drop ≥10 mmHg compared to baseline) at 8 weeks. Results: Valsartan and HCTZ were both effective at lowering diastolic and systolic blood pressure at all time points. Similar falls were seen in both groups with no significant differences between treatments. For the primary variable (decrease in SDBP) there was no significant difference between treatments. For SSBP there was also no significant difference observed. Responder rates at 8 weeks were 74% for valsartan and 62% for HCTZ (P = 0.10). Both treatments were well tolerated, both as monotherapy, and when combined with atenolol 50 mg per day. Conclusion: The data show valsartan 80 mg to be as effective as HCTZ in the treatment of mild-to-moderate hypertension. The results also show valsartan to be well tolerated when taken alone or in combination with atenolol. Received: 7 March 1996 / Accepted in revised form: 29 July 1996     

Antihypertensive effect of low-dose hydrochlorothiazide alone or in combination with quinapril in black patients with mild to moderate hypertension

In this study, using 24-hour ambulatory blood pressure (BP) monitoring, the authors assessed the potential for BP control using hydrochlorothiazide (HCTZ, 12.5 mg daily), given as a monotherapy over 12 months to 49 black South African patients with mild to moderate hypertension (mean day diastolic blood pressure [DBP] > or = 90 and < 115 mmHg). Uncontrolled patients received fixed combination of quinapril/HCTZ 10/12.5, 20/12.5, and 20/25 mg, with dose titration at 3 monthly intervals if BP control was not achieved (day DBP < 90 mmHg). Overall, profound and sustained BP reduction was observed at the end of the study. The 24-hour BP decreased from 151 +/- 14/98 +/- 7 to 136 +/- 15/87 +/- 9 mmHg (p < 0.0001 at end of study vs. baseline); the mean day BP decreased from 155 +/- 14/104 +/- 7 to 140 +/- 15/91 +/- 10 mmHg (p < 0.0001 at end of study vs. baseline). The overall control (mean day DBP < 90 mmHg) and response (decrease in day DBP > or = 10 mmHg) rates were 49% and 61%, respectively. At the end of the study, only 2 patients (4%) remained on treatment with HCTZ. Out of the initial 12 patients controlled on HCTZ at 3 months (12/49, 24%), 5 patients remained controlled at 6 months and only 1 patient at 12 months. In contrast, quinapril/HCTZ combinations maintained their antihypertensive effect up to 9 months, with a significant number of patients (22/49, 45%) requiring the highest dose of the combination (20/25 mg daily). In conclusion, low-dose HCTZ should not be recommended as monotherapy in black patients with mild to moderate hypertension due to the fact that the BP-lowering effect is attenuated already at 6 months of treatment, with most patients requiring the addition of the ACE inhibitor.     

Irbesartan/Hydrochlorothiazide : in moderate to severe hypertension

* The fixed-dose combination of irbesartan/hydrochlorothiazide (HCTZ) is approved in the US for use as initial therapy in patients who are likely to need multiple agents to achieve their blood pressure (BP) goals. * In a 12-week, randomized, double-blind, multicentre trial in 538 patients with moderate hypertension that was untreated or uncontrolled by monotherapy, the mean reduction from baseline in seated systolic BP (SeSBP) at week 8 (primary endpoint) was significantly greater with irbesartan/HCTZ than with either irbesartan or HCTZ as monotherapy. * In addition, the proportion of patients with moderate hypertension achieving controlled BP (SeSBP < 140 mmHg/seated diastolic BP [SeDBP] < 90 mmHg) at 12 weeks was significantly greater with irbesartan/HCTZ combination therapy than with irbesartan or HCTZ monotherapy. * In a 7-week, randomized, double-blind, multicentre trial in 697 patients with severe hypertension that was untreated or uncontrolled by monotherapy, a significantly greater proportion achieved a trough SeDBP of < 90 mmHg following 5 weeks of combination therapy with irbesartan/HCTZ compared with irbesartan monotherapy (primary endpoint). * Furthermore, the proportion of patients with severe hypertension achieving controlled BP of < 140/90 mmHg was significantly greater at all timepoints of the trial compared with irbesartan monotherapy. * Irbesartan/HCTZ combination therapy had a similar tolerability profile to irbesartan and HCTZ monotherapy. Most adverse events were of mild to moderate intensity.     

Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension

ABSTRACT

Objective: Most patients with severe hypertension are at high risk for cardiovascular events and require prompt blood pressure (BP)-lowering and combination therapy to achieve BP goals. This study evaluated the therapeutic efficacy and tolerability of initial treatment with the combination of valsartan and hydrochlorothiazide (HCTZ) compared with valsartan monotherapy in patients with severe hypertension.

Research design and methods: This was a 6-week, randomized, double-blind, multicenter, forced titration study that compared initial therapy with the combination of valsartan/HCTZ 160/12.5?mg (force titrated to 160/25?mg after 2 weeks and to 320/25?mg after 4 weeks) to monotherapy with valsartan 160?mg (force titrated to 320?mg after 2 weeks and sham-titrated to 320?mg after 4 weeks). Eligible patients were 18–80 years old with severe essential hypertension (mean sitting diastolic BP?≥?110?mmHg and <120?mmHg and mean sitting systolic BP?≥?140?mmHg and <200?mmHg). The Clinical Trial Registry number was NCT00273299.

Main outcome measures: The primary efficacy variable was the rate of BP control (mean sitting BP?<?140/90?mmHg) at Week 4. Tolerability was evaluated by monitoring all adverse events, vital signs, and laboratory tests including hematology and biochemistry.

Results: A total of 608 patients were randomized to either valsartan/HCTZ (n?=?307) or valsartan monotherapy (n?=?301). Significantly more patients achieved overall BP control (<140/90?mmHg) with valsartan/HCTZ compared to monotherapy at Week 4 (primary efficacy variable and timepoint) (39.6% vs. 21.8%; p?<?0.0001) and Week 6 (48.2% vs. 27.2%; p?<?0.0001). Mean reductions in BP at Week 4 were significantly greater for valsartan/HCTZ (30.8/22.7?mmHg vs. 21.7/17.5?mmHg; p?<?0.0001), with further reductions at Week 6. BP control rates were greater with combination therapy as early as Week 2. The overall incidence of adverse events was comparable between the combination therapy (34.9%) and monotherapy (36.7%) treatment groups. A potential limitation of the forced-titration design is that some patients were titrated to higher doses despite having achieved goal BP. This may impact the interpretation of the incidence of dose-dependent adverse events.

Conclusions: Initial therapy with valsartan/HCTZ is effective and well tolerated in patients with severe hypertension.     

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.     

Combination antihypertensive therapy with valsartan and hydrochlorothiazide in Chinese patients with mild-to-moderate hypertension

ABSTRACT

Objectives: To compare the efficacy and safety of valsartan (VAL)/ HCTZ 80/12.5?mg with VAL 80?mg in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with VAL 80?mg alone.

Research design and methods: This was a multicenter, double-blind, double-dummy, randomized, active-controlled, parallel-group trial. Patients (1175) with mild-to-moderate essential hypertension (mean sitting diastolic blood pressure [MSDBP] ≥?95 and <?110?mmHg) from 26 centers in China received VAL 80?mg o.d. for 4?weeks, 864 patients whose MSDBP remained ≥?90 and <?110?mmHg were randomized (1:1) to receive VAL80/HCTZ12.5?mg (n?= 429) or VAL80?mg (n?= 435) for 8?weeks.

Main outcome measures: The efficacy variable was changed from baseline to endpoint in trough MSDBP. The secondary efficacy variables were changed in mean sitting systolic blood pressure (MSSBP), response rate, and control rate.

Results: Significant reductions in MSDBP and MSSBP from baseline to endpoint were observed in both groups. There were significantly greater reductions in MSDBP (8.4?mmHg vs. 6.2?mmHg) and MSSBP (10.2?mmHg vs. 6.7?mmHg), higher response (64.2% vs. 52.5%) and control rates (53.9% vs. 40.9%) in the VAL80/HCTZ12.5 group as compared with the VAL80 group at endpoint (?p?<?0.001). VAL80/HCTZ12.5 was equally effective in both age subgroups (≥?65 and <?65?years) and was well tolerated. There were no deaths and the two serious adverse events reported were unrelated to study medication.

Conclusion: In Chinese patients with mild-to-moderate essential hypertension not adequately controlled by VAL 80?mg alone, VAL80/HCTZ12.5?mg combination was well tolerated and showed additional BP reduction. The limitations of this study were the inability to include an HCTZ arm as a control group and the short trial duration.

Trial registration: NCT00250562.