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.     

氢氯噻嗪联合缬沙坦治疗原发性高血压的效果观察

目的探讨氢氯噻嗪联合缬沙坦治疗原发性高血压的临床效果。方法选取2012年1月～2013年1月本院收治的原发性高血压患者160例,将其随机分为观察组和对照组,各80例,对照组采用缬沙坦治疗．观察组在对照组治疗的基础上加用氢氯噻嗪,治疗1个月后比较两组患者的临床效果和血压变化。结果观察组总有效率为87．5％,明显高于对照组的75．0％,差异有统计学意义（P〈0．05）。治疗前,两组患者的DBP、SBP比较差异无统计学意义（P〉0．05）;治疗后,两组患者的DBP、SBP明显下降,与治疗前比较差异有统计学意义（P〈0．05）．且观察组下降较对照组显著,差异有统计学意义（P〈0．05）。两组患者不良反应发生率均为3．75％,差异无统计学意义（P〉0．05）。结论氢氯噻嗪联合缬沙坦治疗原发性高血压效果显著,无严重不良反应,值得临床推广应用。     

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   

心血宁片联合缬沙坦氢氯噻嗪治疗原发性高血压的疗效观察

目的 探讨心血宁片联合缬沙坦氢氯噻嗪治疗原发性高血压的临床疗效。方法 选取2021年3月—2022年3月上海交通大学医学院附属新华医院收治的116例原发性高血压患者，按照随机数字表法分为对照组和治疗组，每组各58例。对照组口服缬沙坦氢氯噻嗪片，1片/次，1次/d。治疗组在对照组治疗基础上口服心血宁片，4片/次，3次/d。两组疗程12周。观察两组疗效及主要症状消失率。比较治疗前后两组诊室血压[收缩压（SBP）、舒张压（DBP）]，24 h动态血压指标及杜氏高血压生活质量量表、世界卫生组织生活质量测定简表（WHOQOL-BREF）评分。结果 治疗后，治疗组总有效率是96.55%，较对照组86.21%显著提高（P＜0.05）。治疗后，两组诊室SBP、DBP均较治疗前显著下降（P＜0.05）；治疗后，治疗组诊室SBP、DBP低于对照组（P＜0.05）。治疗后，两组24 h SBP、24 h DBP、白天SBP（dSBP）、白天DBP（dDBP）、夜间SBP（nSBP）、夜间DBP（nDBP）24 h平均动脉压（24 h MAP）、24 h SBP变异系数（24 h SBPCV）、24 h DBP变异系数（24 h DBPCV）均较治疗前显著降低（P＜0.05）；且以治疗组降低更显著（P＜0.05）。治疗后，治疗组头晕目眩、头痛、胸闷的消失率分别是94.83%、89.66%、79.31%，均显著高于对照组的86.21%、75.86%、62.07%（P＜0.05）。治疗后，两组杜氏高血压生活质量量表评分、WHOQOL-BREF评分均显著增加（P＜0.05），且治疗后，治疗组杜氏高血压生活质量量表评分、WHOQOL-BREF评分均高于对照组（P＜0.05）。结论 心血宁片联合缬沙坦氢氯噻嗪治疗原发性高血压整体效果确切，可有效获得血压的稳定控制及症状的明显缓解，促进患者生活质量的改善，值得临床推广应用。     

苯那普利与小剂量氢氯噻嗪合用治疗高血压疗效观察

目的：研究苯那普利与小剂量氢氯噻嗪合用对高血压患者的疗效。方法：采用随机分组法将60例原发性高血压病人分为两组,A组30例单用苯那普利10mg,每日一次;B组30例用苯那普利10mg,每日一次,加服氢氯噻嗪12．5mg,每日一次。两组治疗时间均为4周。观察治疗前后的基础血压及24h动态血压,并测定治疗前后的空腹血糖、血脂、血尿酸、尿素氮、肌酐。结果：苯那普利加小剂量氢氯噻嗪组的总有效率及24h动态血压的结果明显优于单用苯那普利组,两组治疗前后的代谢指标均无明显改变。结果：苯那普利与小剂氢氯噻嗪合作治疗高血压较单用苯那普利更有效,而且对代谢无明显影响。     

缬沙坦长期治疗原发性高血压病人的安全性和疗效

目的 :评估缬沙坦长期治疗原发性高血压的安全性与疗效。方法 :门诊轻、中度高血压的病人3 2例 (男性 2 3例 ,女性 9例 ,年龄 5 1a±s 9a) ,服用缬沙坦 80mg·d-1,wk 4后血压控制不满意者加量至 1 60mg·d-1,共治疗 2 4wk。结果 :舒张压下降程度在治疗后wk 4,8,1 6,2 4末分别为 :1 .6kPa±0 .9kPa,2 .0kPa± 0 .8kPa,2 .1kPa± 1 .0kPa,1 .8kPa± 0 .8kPa,较治疗前差异均有非常显著意义 (P<0 .0 1 )。wk 4,2 4治疗有效率分别为 78%与 75% (P >0 .0 5 )。未见干咳发生 ,不良反应少 ,耐受性良好。结论 :缬沙坦长期治疗轻、中度原发性高血压安全有效     

奈必洛尔联合缬沙坦治疗原发性高血压有效性和安全性分析

目的观察奈必洛尔联合缬沙坦治疗原发性高血压的有效性和安全性。方法选取98例原发性高血压患者随机分为观察组和对照组,对照组采用缬沙坦进行治疗,观察组采用奈必洛尔联合缬沙坦治疗,2个月后查看疗效和不良反应。结果 8周后观察组治疗总有效率为95.9%,对照组为79.6%,差异比较具有统计学意义(P<0.05);治疗4周和8周后,观察组收缩压、舒张压及静息心率均明显低于对照组,差异比较具有统计学意义(P<0.05);治疗4周及8周后观察组血压达标率均明显高于对照组,差异比较有统计学意义(P<0.05);对照组与缬沙坦有关的不良反应2例,发生率为4.1%。观察组与2种药品有关的不良发应3例,发生率6.1%,2组不良反应率比较差异无统计学意义(P>0.05)。结论奈必洛尔联合缬沙坦治疗原发性高血压疗效显著,安全性高,可在临床上进一步推广。     

Safety and tolerability of eprosartan in combination with hydrochlorothiazide.

The ideal antihypertensive drug should be effective in reducing blood pressure, but have a low incidence of adverse effects. Angiotensin II receptor blockers, such as eprosartan, are as effective as ACE inhibitors in reducing blood pressure, but lack the main adverse effect of ACE inhibitors, namely cough. Eprosartan has been shown to be well tolerated with a placebo-like adverse-effect profile. When given as monotherapy it is effective in reducing blood pressure; however, some patients require additional blood pressure control, which may be provided by combination therapy. Indeed, the combination of eprosartan and the thiazide diuretic hydrochlorothiazide has been shown to be effective in further reducing blood pressure in patients not optimally responding to eprosartan monotherapy. This article reviews the safety and tolerability of eprosartan in combination with hydrochlorothiazide from 17 studies of 1899 patients with hypertension and normotensive volunteers. Of these studies, four were controlled with patients receiving a fixed-dose combination, six were long-term, open-label, and another four were controlled studies with hydrochlorothiazide being given to eprosartan non-responders. The other three studies included healthy subjects receiving the combination of eprosartan and hydrochlorothiazide. There was a high completion rate in all studies evaluated. Most of the patients receiving eprosartan 600mg in combination with hydrochlorothiazide 12.5mg daily completed the studies, which supports acceptance of this combination therapy by patients. The most frequently reported adverse events in these combination studies were headache, dizziness, myalgia, and upper respiratory tract infection in patients with hypertension. The majority of adverse events were mild to moderate in intensity, and were not considered to be related to study treatment. The adverse event that was more common in patients receiving combination therapy compared with those receiving monotherapy was dizziness. This adverse event may be due to hydrochlorothiazide as it has previously been observed in patients taking thiazide diuretics. In healthy volunteers, the most frequently reported adverse events were headache, dizziness, and upper respiratory tract infection. However, none of these adverse events were considered related to study medication. In summary, the combination of eprosartan/hydrochlorothiazide is well tolerated, both as short- and long-term therapy, with most adverse events occurring early. The most frequent adverse events were headache, dizziness, and upper respiratory infection, which would be expected based on the safety profile of each of the components. Therefore, the combination of eprosartan with hydrochlorothiazide can be effectively and safely used in patients not adequately responding to eprosartan monotherapy.     

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...     

缬沙坦氢氯噻嗪对轻中度原发性高血压患者颈动脉内膜中层厚度的影响

目的:探究缬沙坦/氢氯噻嗪对轻中度原发性高血压患者颈动脉内膜中层厚度的影响。方法:选取2014年1月至2016年6月北京市海淀医院收治的244例轻中度原发性高血压患者,采用数字随机法分为观察组和对照组各122例,对照组给予氢氯噻嗪口服,观察组则给予缬沙坦/氢氯噻嗪口服,两组患者均连续治疗6个月,对比两组患者治疗前后的血压,并对治疗前后的肱动脉内皮依赖性舒张功能(EDD)、颈动脉内膜中层厚度(IMT)进行对比。结果:治疗后两组患者的血压水平均较治疗前明显降低(P<0.05),治疗前、治疗后两组患者的血压水平对比均无显著差异(P>0.05);对照组治疗后与治疗前相比EDD及IMT水平均无显著改善(P>0.05),观察组治疗后与治疗前相比EDD明显增高,IMT明显降低,差异具有统计学意义(P<0.05),与同期对照组相比差异具有统计学意义(P<0.05)。结论:缬沙坦/氢氯噻嗪用于轻中度原发性高血压患者的治疗能够有效控制血压,并改善肱动脉内皮功能,减少颈动脉内膜中层厚度,值得在临床上推广和应用。     

养血清脑颗粒联合缬沙坦氢氯噻嗪治疗老年原发性高血压的临床研究

目的 探讨养血清脑颗粒联合缬沙坦氢氯噻嗪片治疗老年原发性高血压的临床疗效。方法 选取2020年6月—2021年11月在保定市第一医院收治的82例老年原发性高血压患者为观察对象,根据随机数字表法将所有患者分为对照组和治疗组,每组各41例。对照组口服缬沙坦氢氯噻嗪片,1片/次,1次/d;治疗组在对照组治疗的基础上温水冲服养血清脑颗粒,1袋/次,3次/d。两组患者连续治疗3个月。观察两组的临床疗效,比较两组的血压指标、血流动力学指标、血清指标。结果 治疗后,治疗组患者的总有效率为95.12%,对照组的总有效率为80.49%,组间比较差异有统计学意义（P＜0.05）。治疗后,两组的24 h收缩压（24 h SBP）、24 h舒张压（24 h DBP）、24 h收缩压标准差（24 h SSD）、24 h舒张压标准差（24 h DSD）明显低于治疗前（P＜0.05）,且治疗组24 h SBP、24 h DBP、24 h SSD、24 h DSD低于对照组（P＜0.05）。治疗后,两组的体循环阻力（SVR）低于治疗前,心排血量（CO）、心脏指数（CI）高于治疗前（P＜0.05）;并且治疗组的SVR低于对照组,CO、CI高于对照组,差异有统计学意义（P＜0.05）。治疗后,两组的血清同型半胱氨酸（Hcy）、内皮素-1（ET-1）水平低于治疗前,一氧化氮（NO）水平高于治疗前（P＜0.05）;治疗组的Hcy、ET-1水平低于对照组,NO水平高于对照组（P＜0.05）。结论 养血清脑颗粒联合缬沙坦氢氯噻嗪片治疗老年原发性高血压的疗效确切,能有效控制血压,改善血流动力学指标和血管内皮功能,安全性良好。     

缬沙坦/氢氯噻嗪治疗原发性高血压有效性和安全性的Meta分析

目的评价复方缬沙坦（缬沙坦/氢氯噻嗪）治疗原发性高血压的有效性及安全性。方法计算机检索中国期刊全文数据库和中国生物医学文献数据库,使用RevMan4.2软件进行评价。结果共纳入12篇随机对照试验,Meta分析结果显示：复方缬沙坦与缬沙坦相比,有效率的差异有统计学意义[OR=2.94,95%CI（2.00,4.32）,P〈0.01],而不良反应发生率的差异无统计学意义[OR=0.91,95%CI（0.55,1.49）,P=0.70];与其它含氢氯噻嗪的复方制剂相比,有效率和不良反应发生率的差异均无统计学意义。结论复方缬沙坦治作为一种新型的固定剂量降压制剂,降压效果优良。     

Telmisartan/hydrochlorothiazide combination therapy in the treatment of essential hypertension

Telmisartan is an angiotensin-II receptor blocker that has demonstrated efficacy in the reduction of blood pressure in patients with hypertension. Patients with hypertension commonly require two or more antihypertensives to reduce their blood pressure to safe levels, and the choice of combination therapy should be informed by clinical trial data. Telmisartan is available in fixed-dose combination with hydrochlorothiazide (telmisartan/HCTZ) in doses of 40 mg/12.5 mg and 80 mg/12.5 mg. Telmisartan/HCTZ has been studied in a number of clinical trials in essential hypertension, for the most part using ambulatory blood pressure monitoring. It has been compared with monotherapy in full patient populations and in non-responders, and has been compared with other drug combinations. Telmisartan/HCTZ provides significantly greater reductions in blood pressure than monotherapy, and significantly increases the percentage of patients who achieve target blood pressure. The reduction in blood pressure achieved by adding HCTZ to telmisartan is greater than that achieved by adding HCTZ to atenolol, despite the fact that telmisartan and atenolol monotherapy had similar efficacy. Telmisartan/HCTZ provides significantly greater reductions than losartan plus HCTZ in 24-h mean blood pressure, primarily due to a significantly greater effect in the risky, early morning hours. Telmisartan/HCTZ is effective and well-tolerated in the elderly, diabetics and African-American patients. Ongoing studies are comparing the efficacy of telmisartan/HCTZ with valsartan plus HCTZ and amlodipine plus HCTZ in overweight, hypertensive diabetics and in patients with isolated systolic hypertension – two patient groups who are particularly at risk of target organ damage.     

Telmisartan/hydrochlorothiazide combination therapy in the treatment of essential hypertension

Telmisartan is an angiotensin-II receptor blocker that has demonstrated efficacy in the reduction of blood pressure in patients with hypertension. Patients with hypertension commonly require two or more antihypertensives to reduce their blood pressure to safe levels, and the choice of combination therapy should be informed by clinical trial data. Telmisartan is available in fixed-dose combination with hydrochlorothiazide (telmisartan/HCTZ) in doses of 40 mg/12.5 mg and 80 mg/12.5 mg. Telmisartan/HCTZ has been studied in a number of clinical trials in essential hypertension, for the most part using ambulatory blood pressure monitoring. It has been compared with monotherapy in full patient populations and in non-responders, and has been compared with other drug combinations. Telmisartan/HCTZ provides significantly greater reductions in blood pressure than monotherapy, and significantly increases the percentage of patients who achieve target blood pressure. The reduction in blood pressure achieved by adding HCTZ to telmisartan is greater than that achieved by adding HCTZ to atenolol, despite the fact that telmisartan and atenolol monotherapy had similar efficacy. Telmisartan/HCTZ provides significantly greater reductions than losartan plus HCTZ in 24-h mean blood pressure, primarily due to a significantly greater effect in the risky, early morning hours. Telmisartan/HCTZ is effective and well-tolerated in the elderly, diabetics and African-American patients. Ongoing studies are comparing the efficacy of telmisartan/HCTZ with valsartan plus HCTZ and amlodipine plus HCTZ in overweight, hypertensive diabetics and in patients with isolated systolic hypertension - two patient groups who are particularly at risk of target organ damage.     

缬沙坦联合氢氯噻嗪治疗高血压的疗效观察

目的观察缬沙坦联合氢氯噻嗪治疗高血压的临床疗效。方法 80例患者随机分为观察组和对照组各40例。观察组给予缬沙坦联合氢氯噻嗪治疗,对照组给予卡托普利联合硝苯地平控释片治疗。2组疗程均为6个月。观察2组血压改善情况。结果观察组总有效率为97.5%高于对照组的92.5%,差异有统计学意义（P〈0.05）。2组治疗后血压均较治疗前改善,且观察组改善情况优于对照组,差异均有统计学意义（P〈0.05）。结论缬沙坦联合氢氯噻嗪治疗高血压疗效好、安全性好,且用药依从性好,是理想的降压治疗方法。     

Efficacy and tolerability of tiapamil in patients with mild to moderate essential hypertension

Although early experience with tiapamil, a new calcium antagonist structurally related to verapamil, showed good antihypertensive efficacy and minimal adverse effects, recent studies have shown conflicting results. This single-blind dose-titration study was designed to determine the therapeutic efficacy, duration of action, and safety profile of tiapamil in patients with essential hypertension. After a 2-week washout period, patients received placebo for 4 weeks. Patients with a sitting diastolic blood pressure (SDBP) of 95-114 mm Hg received tiapamil 300 mg twice daily with dose increments of 150 mg twice daily every 2 weeks to a maximum of 1,200 mg/day. Once blood pressure (BP) control was achieved or patients were receiving 600 mg twice daily, they were followed up for an additional 2 weeks. Twenty of the initial 31 patients completed the trial, and 17 patients were receiving the highest dose of tiapamil. Nine patients dropped out because of adverse effects. No significant decreases in BP and heart rate (HR) were either noted by the clinic or apparent by 24-h ambulatory BP readings. Random assays of drug supplies showed that patients received the required dosage. The incidence of adverse effects rose with increasing doses of tiapamil: 27.6% of patients at 300 mg twice daily, 48% at 450 mg twice daily, and 81.8% at 600 mg twice daily. Dizziness, headache, and palpitations were the most frequent adverse effects. These results show that tiapamil given at a daily dose of 600-1,200 mg exhibits very little effect in lowering BP in patients with mild to moderate essential hypertension. Moreover, the incidence of adverse effects is much higher than reported in earlier studies.     

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。     

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.