缬沙坦与苯那普利治疗老年高血压的对照研究

目的观察比较缬沙坦与苯那普利治疗老年人轻、中度原发性高血压的疗效和安全性。方法选择103例老年高血压患者,随机分为治疗组52例和对照组51例,治疗组给予缬沙坦80～160mg/d,对照组给予苯那普利10～20mg/d,观察两组患者4周和8周的疗效。结果两组患者治疗第2周后平均收缩压、舒张压较治疗前明显降低(P＜0．01),在整个治疗期间血压持续平稳下降；缬沙坦与苯那普利治疗4周降低舒张压总有效率分别为86．4%及84．3%,8周降低舒张压总有效率分别为92．3%及90．2%,两组比较差别无显著性意义(P＞0．05)。结论缬沙坦是一种安全、有效、长效。耐受性好不良反应少的降压药物。     

氯沙坦、苯那普利及二者联合治疗高血压病的对比性研究

目的对比氯沙坦、苯那普利及二者联合治疗轻、中度原发性高血压(EH)的降压效果及耐受性.方法入选的轻、中度EH患者(坐位舒张压90～109 mmHg)经1周药物冲洗期及2周安慰剂期后,随机分为3组(1)L组,口服氯沙坦 50 mg/天;(2)B组,口服苯那普利 10 mg/天;(3)L+B组,口服氯沙坦 50 mg/天,苯那普利 10 mg/天.疗程8周.共入选病例67例,完成8周观察者63例,L组22例,B组20例,L+B组21例.于服安慰剂期末及治疗1、2、4、6、8周末测诊室血压、心率(HR)并记录不良反应.治疗前后测血浆肾素活性(PRA)、血管紧张素Ⅱ(AngⅡ)、醛固酮(ALD)浓度.结果治疗8周后三组血压均下降,其中L组下降10.8±6.2/17.5±5.5 mmHg,总有效率59.1%;B组下降11.2±5.4/16.4±4.6 mmHg,总有效率65.0%;L+B组下降26.4±5.7/32.1±11.0 mmHg,总有效率95.2%.L+B组降压幅度最大,与L组、B组比较有统计学意义(P＜0.001).L组与B组的降压幅度及有效率无显著差异(P＞0.05).三组血浆ALD浓度在治疗后均下降,其中L+B组ALD下降较L组与B组显著(P＜0.001).氯沙坦组不良反应少.结论氯沙坦有明显降压作用,与苯那普利合用有叠加效应.     

4种抗高血压药物对血压和血压变异性的影响

目的:研究4种不同类型的抗高血压药物对血压变异性(blood pressure variability,BPV)的影响。方法:99例轻、中度原发性高血压患者,分别服用多沙唑嗪1mg/d(30例)、塞利洛尔100mg/d(18例)、咪达普利5mg/d(31例)和左旋氨氯地平2.5mg/d(20例),比较治疗前和治疗8周后动态血压和BPV的变化。结果:①多沙唑嗪、咪达普利和左旋氨氯地平组白昼的收缩压和舒张压分别降低9.67/6.64mmHg(1mmHg=0.133kPa)、5.06/2.39mmHg和9.65/5.35mmHg,而左旋氨氯地平组还降低夜间的收缩压和舒张压12.60/8.45mmHg;②多沙唑嗪组和左旋氨氯地平组能降低BPV,多沙唑嗪组24h收缩压、舒张压和白昼的收缩压变异分别减少19.0%、13.8%和12.5%(P<0.05或P<0.01),左旋氨氯地平组夜间收缩压、舒张压变异分别减少27.4%和18.1%(P<0.01和P<0.05)。结论:①多沙唑嗪、咪达普利和左旋氨氯地平组白昼的降压幅度较为明显,而左旋氨氯地平组还能降低夜间的血压;②多沙唑嗪组和左旋氨氯地平组能降低BPV。     

缬沙坦与赖诺普利治疗原发性高血压患者在耐受性、安全性和疗效上的比较

目的 :评价缬沙坦 (valsartan)治疗原发性高血压患者的耐受性、安全性和疗效。　　方法 :146例轻、中度原发性高血压患者采用随机双盲的研究方法分为缬沙坦组 (n=75 )和赖诺普利 (lisinopril)组 (n=71) ,分别接受缬沙坦 80 mg/d或赖诺普利 10 mg/d,4周后血压控制不满意者 (舒张压≥ 90 mm Hg,1mm Hg=0 .133k Pa) ,接受缬沙坦 16 0 mg/d或赖诺普利 2 0 mg/d。　　结果 :缬沙坦与赖诺普利均能有效降低血压。治疗总有效率分别为 6 0 .3%和 6 4.1% ,降压程度及治疗有效率比较统计学无显著性差异 (P>0 .0 5 )。缬沙坦组具有良好的耐受性 ,未见干咳现象 ,而赖诺普利组干咳发生率达 5 .6 %。　　结论 :缬沙坦是治疗轻、中度原发性高血压安全有效的药物。     

伊贝沙坦治疗原发性高血压的疗效和安全性评价

目的评价伊贝沙坦(irbesartan)治疗轻、中度原发性高血压的疗效和安全性.方法选取137例坐位舒张压(SeDBP)95～115mmHg(1mmHg＝0.133kPa)[根据1993年<新药(西药)临床研究指导原则>治疗前舒张压水平分成轻(95～104mmHg)、中(105～114mmHg)和重(＞115mmHg)三类]的轻、中度原发性高血压患者,随机分为伊贝沙坦组(150mg每日1次)和贝那普利(benazepril)组(10mg每日1次).于4周末SeDBP≥90mmHg者剂量分别加倍,继续服用4周.于安慰剂期末及治疗2、4、6、8周测诊室血压、心率并记录症状、体征;试验前后行实验室检查.结果有效率伊贝沙坦组81.2%,贝那普利组70.5%,两组比较无显著性差异(P＞0.05).8周伊贝沙坦组及贝那普利组SeSBP/SeDBP均下降,其中2、4、6、8周伊贝沙坦组SeDBP的下降幅度大于贝那普利组,两组有显著性差异(4周P＜0.05,2、6、8周P均＜0.01).贝那普利组咳嗽5例,发生率8%.结论伊贝沙坦150～300mg/d治疗轻、中度原发性高血压的有效率近似于贝那普利10～20mg/d,但耐受性好于贝那普利.     

伊贝沙坦治疗轻、中度原发性高血压疗效观察

目的通过伊贝沙坦(国产)与缬沙坦(合资)的对比研究来评价伊贝沙坦对轻、中度原发性高血压的降压疗效和安全性.方法53例轻、中度原发性高血压患者被随机、双盲分为两组,经口服安慰剂2周后,分别每日口服1次伊贝沙坦75～150mg(伊贝沙坦组)或缬沙坦80～160mg(缬沙坦组),治疗4周,观察用药前后坐位血压、心率变化,对比用药前后血生化、血尿常规检查结果,记录患者用药后的不良反应.结果治疗4周后,伊贝沙坦组舒张压降低13.3±8.7mmHg(1mmHg＝0.133kPa)缬沙坦组舒张压降低16.5士9.3mmHg.两组治疗后与治疗前相比,血压下降有非常显著差异(P＜0.01),心率变化、血生化及血尿常规检查结果比较无显著差异(P＞0.05).总有效率及不良反应发生出率两组间比较均无显著差异(P＞0.05).结论口服伊贝沙坦75～150mg,每日1次,对轻、中度原发性高血压降压疗效确切,患者耐受性好.     

复方缬沙坦治疗轻中度原发性高血压患者的疗效观察

目的评价复方缬沙坦（缬沙坦80mg／氢氯噻嗪12．5mg复方制剂）治疗经单用缬沙坦80mg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。对经2周洗脱期的轻、中度原发性高血压患者[坐位舒张压≥95mmHg（1mmHg=0．133kPa）且〈110mmHg]采用单药缬沙坦80mg／d治疗4周,在单药导入结束后,坐位舒张压仍〉190mmHg的864例患者按1：1随机、双盲分为复方缬沙坦组或缬沙坦80mg／d组,继续治疗8周。在治疗4周和结束时评估药物安全性及有效性。结果在轻、中度原发性高血压患者中复方缬沙坦每日1次比单用缬沙坦80mg／d血压进一步下降、达标率提高。治疗结束时平均坐位收缩压多降低3．5mmHg,平均坐位舒张压多下降2．2mmHg,血压控制〈140／90mmHg的患者在复方缬沙坦组和单用缬沙坦80mg／d组分别为53．9％及40．9％。结论轻、中度原发性高血压患者采用复方缬沙坦治疗组降压有效率及达标率均优于每日1次服用缬沙坦80mg／d组。复方缬沙坦适用于缬沙坦单药控制不良的轻、中度原发性高血压患者。     

缬沙坦治疗高血压病对肾功能的影响

目的应用新一代降压药物血管紧张素受体拮抗剂(ARB)缬沙坦治疗轻、中度原发性高血压,观察降压效果及治疗前后肾功能的变化。方法选择轻、中度高血压病人停服原用药1周再服用安慰剂1周后,随机分为2组。缬沙坦组服用缬沙坦80～160mg/d;苯那普利组服用苯那普利10～20mg/d。入选病例65例,完成8周观察者共61例,缬沙坦组32例,苯那普利组29例。监测血压每周一次,并记录出现的不良反应。用药前后测血尿素氮、血肌酐、血尿酸、尿β2-MG、24h尿微量ALB。结果治疗8周后两组血压均下降,缬沙坦组下降(16.5±7.5/10.2±6.8)mmHg,总有效率为59.4%;苯那普利组下降(16.4±9.6/11.2±7.4)mmHg,总有效率62.1%,两组之间无显著的统计学差异。两组尿β2-MG、24小时尿微量ALB在治疗后均下降,亦无显著差异。结论缬沙坦有明显降压作用,副作用少,可降低尿中ALB及尿β2-MG,减轻肾脏病变。     

复方缬沙坦与血脂康联合治疗原发性高血压的临床研究

目的评价复方缬沙坦(缬沙坦80mg/氢氯噻嗪12.5mg)联合血脂康(600mg)治疗轻、中度原发性高血压患者的疗效和安全性。方法采用随机、双盲对照研究。将280例轻、中度高血压患者随机分为缬沙坦组和对照组。缬沙坦组患者给予复方缬沙坦(缬沙坦80mg/氢氯噻嗪12.5mg,1次/d)和血脂康(600mg,2次/d)治疗,对照组患者降压药物单用缬沙坦(80mg,1次/d)。治疗中每周测量血压。在治疗8周和结束时评价药物安全性和有效性。结果对于轻、中度原发性高血压患者,缬沙坦组较对照组血压进一步下降,达标率显著高于对照组。治疗结束时平均坐位收缩压均降低5mmHg,平均坐位舒张压多下降3mmHg,缬沙坦组和对照组患者中,血压控制<140/90mmHg者分别占54.1%和40.7%。结论轻、中度原发性高血压患者采用复方缬沙坦联合血脂康治疗,降压效果和达标率均优于单用缬沙坦。     

氯沙坦钾和盐酸苯那普利对老年高血压患者疗效的比较

目的比较氯沙坦钾和盐酸苯那普利对老年高血压患者的降压疗效和安全性。方法70例轻中度高血压者随机选用氯沙坦钾50mg或盐酸苯那普利10mg，每日一次口服，共24周。24h动态血压监测血压的改变。结果共62例完成随访。氯沙坦钾组(n=35)治疗后总体SBP和DBP较治疗前下降9.05mmHg和4.89mmHg；盐酸苯那普利组(n=27)治疗后总体SBP和DBP较治疗前下降7.19mmHg和2.00mmHg，有效率分别为51.43％和51.85％，两组无显著性差别。随访的老年高血压患者治疗期间无一例发生心脑血管事件。氯沙坦钾组中咳嗽发生率占2.86％，低于盐酸苯那普利组的25.93％。结论氯沙坦钾治疗老年轻中度高血压和盐酸苯那普利均有效，安全性好且耐受性优于盐酸苯那普利。     

Valsartan: Long Term Efficacy and Tolerability Compared to Lisinopril in Elderly Patients with Essential Hypertension

A total of 501 elderly patients with essential hypertension were randomized to receive valsartan or lisinopril in this one year multi-center, double-blind, parallel group trial. Patients received valsartan 40 mg (n=334) or lisinopril 2.5 mg (n=167) daily for 2 weeks with subsequent titration (alone or in combination with hydroclorothiazide), depending on response to treatment. The primary efficacy variable was the percentage of patients with a response, defined as sitting diastolic blood pressure <90 mmHg or drop of ≥10 mmHg from baseline.

A high percentage of patients responded to treatment in both valsartan and lisinopril groups: 80% for both groups at 12 weeks and 81% and 87%, respectively, at 52 weeks with no statistically significant difference between treatments (12 weeks, p= 0.925; 52 weeks, p= 0.148).     

The effect duration of candesartan cilexetil once daily, in comparison with enalapril once daily, in patients with mild to moderate hypertension

OBJECTIVE: To determine the antihypertensive efficacy, effect duration and safety of the angiotensin II type 1 receptor blocker candesartan cilexetil and the angiotensin converting enzyme inhibitor enalapril once daily in patients with mild to moderate hypertension. METHODS: A multicenter, randomised, double-blind parallel group study was performed in Finland, France, the Netherlands, Spain and Sweden. Three-hundred-and-ninety-five men and women in the age range 20-80 years with primary hypertension were randomised to an 8-week double-blind treatment period with either candesartan cilexetil 8-16 mg or enalapril 10-20 mg once daily, with forced dose titration after 4 weeks. Non-invasive ambulatory blood pressure was measured for 36 h at baseline and after 8 weeks. The primary efficacy variable was the change in mean diastolic and systolic ambulatory blood pressure 22-24 h post-dose. RESULTS: There was a significant difference in the adjusted mean difference for the change from baseline to week 8 between candesartan cilexetil and enalapril 22-24 h post-dose by -3.5 mmHg (95% confidence interval, CI: -6.8 to -0.3 mmHg; p < 0.032) in ambulatory systolic blood pressure and -3.0 mmHg (95% CI: -5.1 to -0.8 mmHg; p < 0.008) in ambulatory diastolic blood pressure. There was a significant difference in adjusted mean daytime ambulatory blood pressure 24-36 h post-dose by -4.2 mmHg (95% CI: -6.8 to -1.6 mmHg; p < 0.002)/-3.5 mmHg (95% CI: -5.1 to -1.8 mmHg; p < 0.001). Both drugs were generally well tolerated. CONCLUSION: The results of the present study suggest that advantages may be attributed to the use of candesartan cilexetil, as compared to enalapril in the treatment of patients with essential hypertension. In comparison with enalapril 20 mg, candesartan cilexetil 16 mg more effectively lowered blood pressure at trough and in particular on the day following the day after the last dose.     

The efficacy and tolerability of losartan versus atenolol in patients with isolated systolic hypertension. Losartan ISH Investigators Group

OBJECTIVE: To compare the efficacy and tolerability of angiotensin II (Ang II) antagonist losartan and the beta-blocker atenolol in the treatment of patients with isolated systolic hypertension (ISH) after 16 weeks of treatment. METHODS: A double-blind, randomized, multi-country study was carried out in 273 patients with ISH. Patients with a sitting systolic blood pressure (SiSBP) of 160-205 mmHg, and a sitting diastolic blood pressure (SiDBP) < 90 mmHg at screening and at placebo baseline were subjected to a 4-week placebo period and then randomly grouped to receive 50 mg losartan or 50 mg atenolol once daily for 16 weeks. At 8 and 12 weeks, patients not controlled (SiDBP > or = 160 mmHg) were given additional treatment of 12.5 mg hydrochlorothiazide (HCTZ) once daily. RESULTS: Similar significant reductions in SiSBPs (mean +/- SD) were obtained with 50 mg losartan and 50 mg atenolol, from 173.7 +/- 10.3 and 173.5 +/- 10.7 mmHg at baseline to 149.0 +/- 15.5 and 148.2 +/- 15.3 mmHg after 16 weeks of losartan or atenolol treatment respectively. Sixty-seven percent of the losartan-treated and 64% of the atenolol-treated patients remained on monotherapy throughout the study. Only 1.5% of the losartan-treated patients withdrew because of a clinical adverse event (CAE) compared with 7.2% in the atenolol-treatment group (P= 0.035). Drug-related CAEs were observed significantly more frequently with atenolol than with losartan treatment (20.3 versus 10.4%; P = 0.029). CONCLUSION: It is concluded that 50 mg losartan and 50 mg atenolol produced comparable reductions in SiSBP in patients with ISH but losartan was better tolerated. This is the first demonstration of the therapeutic value of selective Ang II receptor blockade with losartan in the treatment of ISH.     

Pilot study of combined blockade of the renin-angiotensin system in essential hypertensive patients

BACKGROUND: Additive hemodynamic effects of combined blockade of the renin-angiotensin system by an angiotensin I converting enzyme inhibitor and an angiotensin II antagonist have been observed in sodium-depleted normotensive volunteers and in patients with congestive heart failure. OBJECTIVE: To investigate whether the same additive hemodynamic effects occur in patients with hypertension and to verify the safety of such an approach. DESIGN: Multicenter, randomized, double-blind, parallel-group, pilot study. PATIENTS: 177 patients with mild-to-moderate hypertension [diastolic blood pressure (DBP): 95-115 mmHg after a 4-week placebo run-in period] were included in the study. INTERVENTION: Combination therapy consisting of 50 mg losartan daily and 10 mg enalapril daily was administered for 6 weeks. The effects of this therapeutic regimen was compared with similar groups of patients who received either 50 mg losartan daily or 10 mg enalapril daily. MAIN OUTCOME MEASURES: 24-hour ambulatory mean DBP and clinic DBP measured at trough after 6 weeks of treatment. RESULTS: 24-hour ambulatory mean DBP did not significantly differ between treatment groups although the combination tended to lower BP more. The combination therapy was more effective on clinic DBP measured at trough than was losartan by 3.2 mmHg [confidence interval (95%, CI) 0.7-5.7 mmHg, P = 0.012], and more effective than enalapril by 4.0 mmHg (95% CI, 1.5-6.4 mmHg, P = 0.002). In a subgroup of 28 patients, higher plasma active renin and angiotensin I levels during blockade by the combination therapy were observed. This finding confirmed that the combination of the two agents inhibited the renin-angiotensin system to a greater extent than did either agent alone. CONCLUSION: A combination of 10 mg enalapril daily and 50 mg losartan daily safely induces a supplementary, although modest, fall in clinic DBP in patients with mild-to-moderate essential hypertension.     

Valsartan, a new angiotensin II antagonist; blood pressure reduction in essential hypertension compared with an angiotensin converting enzyme inhibitor, enalapril

OBJECTIVE: To compare the blood pressure reduction induced by valsartan, a new angiotensin II receptor antagonist, with that induced by enalapril, an angiotensin converting enzyme (ACE) inhibitor in essential hypertension. METHODS: In total 189 adult outpatients with uncomplicated essential hypertension participated in this double-blind study. Patients were allocated randomly in equal numbers to be administered 80 mg valsartan or 20 mg enalapril daily for 12 weeks. Patients whose blood pressure had not been controlled adequately despite 8 weeks of monotherapy were administered additional therapy with 12.5 mg hydroclorothiazide (HCTZ) daily thereafter. Patients were assessed aftger 4, 8 and 12 weeks of therapy. The primary efficacy variable was the change from baseline in mean sitting diastolic blood pressure (SDBP) after 8 weeks of therapy. Other variables analyzed included the change in sitting systolic blood pressure and percentage responses after 8 weeks of therapy. RESULTS: Valsartan and enalapril were both effective at lowering the blood pressure. Similar falls were induced in the two groups with a similar time course of blood pressure reduction. The mean decreases in SDBP after 8 weeks of therapy were 13.2 mmHg for valsartan and 12.0 mmHg for enalapril. There was no significant difference between the treatments [P = 0.475, 95% confidence interval of the estimated difference (SBP after therapy - SDBP before therapy) -3.5 to 1.6 mmHg]. After 8 weeks of therapy 60.6% had responded to valsartan and 52.6% to enalapril (P = 0.267). Both treatments were tolerated well. Three patients administered enalapril and one patient administered valsartan discontinued their treatment because it made them cough. CONCLUSION: The data show that 80 mg valsartan is as effective as 20 mg enalapril in the treatment of moderate hypertension and that it is tolerated well.     

Efficacy and Safety of Eprosartan in Severe Hypertension

The efficacy of eprosartan, a highly selective, orally-active non-biphenyl, non-tetrazole, type 1 angiotensin II (AT1) receptor antagonist, was compared with that of the angiotensin-converting enzyme (ACE) inhibitor, enalapril, with the addition of hydrochlorothiazide (HCTZ) when necessary in patients with severe hypertension (sitting diastolic blood pressure [sitDBP] > or = 115 mmHg and < or = 125 mmHg). Patients (n = 118) were randomized into an 8-week, double-blind titration phase and were started on oral eprosartan 400 mg total daily dose, given b.i.d., or oral enalapril 10 mg total daily dose, given o.d. The dose of eprosartan was increased to 600 and 800 mg daily, given b.i.d., and that of enalapril to 20 and 40 mg daily, given o.d., at weeks 2 and 4 if sitDBP was > or = 90 mmHg. If blood pressure remained uncontrolled on maximum doses of eprosartan or enalapril at week 6, HCTZ 25 mg o.d. was added to the treatment regimen. Patients whose blood pressure was deemed medically acceptable by the investigator at week 8 entered a 2-week maintenance phase on the final dose used in the titration phase. The primary efficacy measure was the difference between treatments of the mean reduction from baseline in sitDBP at the end of the study. Eprosartan and enalapril caused a similar reduction in sitDBP at study endpoint. The mean change in sitDBP at the end of the study for the eprosartan group was -20.1 mmHg vs -16.2 mmHg for the enalapril group. However, eprosartan produced significantly greater decreases in both sitting and standing systolic blood pressure (sitSBP and staSBP, respectively) than enalapril. The mean decrease in sitSBP was 29.1 mmHg for eprosartan compared with 21.1 mmHg for enalapril (p = 0.025). The mean reduction in staSBP was 27.8 mmHg for eprosartan compared with 20.0 mmHg for enalapril (p = 0.032). At the end of the study, the response rate (sitDBP < 90 mmHg or decreased from baseline by at least 15 mmHg) was 69.5% in the eprosartan group and 54.2% in the enalapril group. The proportion of patients in each treatment group who required addition of HCTZ was similar. Eprosartan was well tolerated; the overall incidence of adverse events was comparable to that in the enalapril group. These results demonstrate that in patients with severe hypertension, eprosartan is well tolerated and may be more effective than enalapril in reducing systolic blood pressure.     

Effect on blood pressure of lumiracoxib versus ibuprofen in patients with osteoarthritis and controlled hypertension: a randomized trial

OBJECTIVES: Nonsteroidal anti-inflammatory drugs vary in their impact on blood pressure and the effect of lumiracoxib 100 mg once daily has not been studied previously. To examine whether lumiracoxib 100 mg once daily would result in lower 24-h mean systolic ambulatory blood pressure than ibuprofen 600 mg three times daily in osteoarthritis patients with controlled hypertension, a 4-week, randomized, double-blind, parallel-group study was conducted in 79 centres in nine countries. METHODS: Hypertensive osteoarthritis patients of 50 years at least whose office blood pressure was less than 140/90 mmHg on stable antihypertensive treatment were randomized to lumiracoxib (n = 394) 100 mg once daily or ibuprofen 600 mg three times daily (n = 393) and 24-h ambulatory blood pressure monitoring was performed at baseline and end of study. The primary outcome measure was a comparison of the change in 24-h mean systolic ambulatory blood pressure from baseline to week 4. Secondary analyses included other blood pressure-related endpoints and efficacy (pain) measurements. RESULTS: Compared with baseline, the 24-h mean systolic ambulatory blood pressure (least square mean) decreased in lumiracoxib-treated patients (-2.7 mmHg) and increased in ibuprofen-treated patients (+2.2 mmHg) at 4 weeks, estimated difference -5.0 mmHg (95% confidence interval -6.1 to -3.8) in favour of lumiracoxib. The 24-h mean diastolic ambulatory blood pressure changes were -1.5 mmHg (lumiracoxib), +0.5 mmHg (ibuprofen), difference -2.0 mmHg (95% confidence interval -2.7 to -1.3). Efficacy results were comparable. CONCLUSIONS: Treatment with lumiracoxib 100 mg once daily resulted in clinically significant lower blood pressure compared with ibuprofen 600 mg three times daily in osteoarthritis patients with well controlled hypertension.     

Efficacy and tolerability of felodipine ER and diltiazem SR as monotherapy in primary hypertension: A double-blind randomized study

Summary Purpose: Efficacy, tolerability, and optimal doses of felodipine ER (FER) and diltiazem SR (DSR), given as monotherapy, were evaluated in patients with mild or moderate primary hypertension. Methods: This was a multicenter, double-blind, parallel-group study of 98 hypertensive patients. Following a 4 weeks placebo run-in period, patients were randomized to either FER 5 mg once daily (qd) or DSR 90 mg twice daily (bid). If supine DBP was >90 mmHg after 2 and 4 weeks treatment, the dose was increased to 10 mg FER qd or 120 mg DSR bid plus 20 mg FER qd or 180 mg DSR bid, respectively. The double-blind treatment lasted 8 weeks. Results: After 8 weeks FER treatment 70% of the patients responded (DBP 90 mmHg or DBP decrease 10 mmHg) and 50% became normotensive (DBP 90 mmHg); the corresponding figures for DSR were 63% and 37%, respectively. No statistical significant differences in BP reduction and HR were found between the two compounds. HR did not change during the study. Seven patients discontinued due to adverse events (AEs). Five patients received FER and two patients received DSR. The AEs were similar in the two groups and generally mild. Conclusions: At the highest dose levels of FER and DSR, no further BP reduction was observed, but there was a tendency to report more AEs. Both FER and DSR can be used as first-line therapy in hypertension.     

Cardiovascular events in elderly patients with isolated systolic hypertension. A subgroup analysis of treatment strategies in STOP-Hypertension-2

Objective: To perform a subgroup analysis on those patients in STOP-Hypertension-2 who had isolated systolic hypertension. Design and methods: The STOP-Hypertension-2 study evaluated cardiovascular mortality and morbidity in elderly hypertensives comparing treatment with conventional drugs (diuretics, beta-blockers) with that of newer ones [angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists]. In all, 6614 elderly patients with hypertension (mean age 76.0 years, range 70-84 years at baseline) were included in STOP-Hypertension-2. In the present subgroup analysis of STOP-Hypertension-2, isolated systolic hypertension was defined as systolic blood pressure at least 160 mmHg and diastolic blood pressure below 95 mmHg, in accordance with the Syst-Eur and Syst-China study criteria. In total, 2280 patients in STOP-Hypertension-2 met these criteria. In the study, patients were randomized to one of three treatment groups: “conventional” antihypertensive therapy with beta-blockers or diuretics (atenolol 50 mg, metoprolol 100 mg, pindolol 5 mg, or fixed-ratio hydrochlorothiazide 25 mg plus amiloride 2.5 mg daily); ACE inhibitors (enalapril 10 mg or lisinopril 10 mg daily); or calcium antagonists (felodipine 2.5 mg or isradipine 2.5 mg daily). Analysis was by intention to treat. Results: The blood pressure lowering effect in patients with systolic hypertension was similar with all three therapeutic regimens: 35/13 mmHg in the conventional group (n = 717), 34/12 mmHg in the ACE inhibitor group (n = 724), and 35/13 mmHg in the calcium antagonist group (n = 708). Prevention of cardiovascular mortality, the primary endpoint of the study, did not differ between the three treatment groups. All stroke events, i.e. fatal and non-fatal stroke together, were significantly reduced by 25% in the newer-drugs group compared with the conventional group (95% CI 0.58-0.97; p = 0.027). This difference was attributable to reduction of non-fatal stroke while fatal stroke events did not differ between groups. New cases of atrial fibrillation were significantly increased by 43% (95% CI 1.02-1.99; p = 0.037) on “newer” drugs compared with “conventional” therapy, mainly attributable to the calcium antagonists. There were no significant differences between the three treatment groups with respect to the risks of myocardial infarction, sudden death or congestive heart failure. Conclusions: The analysis demonstrated that “newer” therapy (ACE inhibitors/calcium antagonists) was significantly better (25%) than “conventional” (diuretics/beta-blockers) in preventing all stroke in elderly patients with isolated systolic hypertension.     

Eprosartan versus enalapril in elderly patients with hypertension: a double-blind, randomized trial.

AIM: To compare the efficacy and safety of eprosartan and enalapril to lower systolic blood pressure in elderly patients with essential hypertension. METHODS: 334 patients >65 years with sitting systolic blood pressure (sitSBP) > or = 160 mmHg and diastolic blood pressure (sitDBP) 90-114 mmHg were randomized to 12 weeks of double-blind treatment with eprosartan, 600-800 mg once daily (o.d.) or enalapril (5-20 mg o.d.), with flexible dose titration to lower systolic blood pressure below 140 mmHg. The primary outcome measure was change in sitSBP at endpoint. RESULTS: Least-squares mean changes from baseline in sitSBP were -18.0 and -17.4 mmHg in the eprosartan and enalapril groups, respectively (difference eprosartan-enalapril -0.6, 95% confidence interval, CI, -4.1 to 3.0, p = 0.76). The corresponding figures for sitDBP were -9.4 and -9.6 mmHg (difference eprosartan-enalapril 0.2, 95% CI -1.7 to 2.0, p = 0.84). Normalization and response rates were also similar in the two groups. Adverse events were recorded in 61 (35.7%) patients on eprosartan (one with dry cough) and 83 (50.9%) patients on enalapril (10 with dry cough). CONCLUSIONS: Eprosartan and enalapril were equally effective in reducing sitSBP and sitDBP in elderly patients with predominantly systolic hypertension. Eprosartan was better tolerated and, in particular, lacked the propensity of enalapril to cause dry cough.