Treatment of hypertension in patients > or =65 years of age: experience with amlodipine

BACKGROUND: Hypertension is a common finding in patients > or =65 years of age that contributes to cardiovascular morbidity and mortality, but many patients are untreated or their hypertension inadequately controlled. Recent randomized controlled studies have demonstrated the benefits of treating hypertension in the elderly. OBJECTIVE: This study was undertaken to assess the efficacy and tolerability of amlodipine, a long-acting calcium channel blocker, in elderly (> or =65 years of age) patients with mild to moderate hypertension (diastolic blood pressure 95 to 114 mm Hg). METHODS: This was an open-label, multicenter, 10-week, general-practice study involving patients >18 years of age. Patients with malignant or secondary hypertension or unstable angina were excluded, as were those who had experienced an acute myocardial infarction or stroke in the preceding 3 months or had been treated with an alpha-blocker in the preceding 6 months. Patients were assigned to 1 of 4 treatment schedules: amlodipine monotherapy or combination therapy and amlodipine given once daily in the morning or in the evening. Approximately 50% of patients would receive a morning dose, and approximately 80% would receive amlodipine as monotherapy. The paired t test was used to assess the significance of differences from baseline values, with significance set at P < 0.05. RESULTS: A total of 5135 patients received amlodipine and were included in the tolerability analysis. Of these, 3511 of 3628 patients (96.8%) <65 years and 1471 of 1507 patients (97.6%) > or =65 years (including 336 of 349 [96.3%] > or =75 years) were included in the efficacy analysis. Significant reductions (P < 0.05) in blood pressure were noted in all groups after 4 and 8 weeks of treatment. The equivalence of efficacy in all age groups was seen in terms of reduction in blood pressure (reduction of 21/15 mm Hg in patients <65 years of age, 25/16 mm Hg in those > or =65 years of age, and 26/17 mm Hg in those > or =75 years of age) compared with baseline. Therapy was successful in 2878 patients (82.0%) <65 years of age, in 1238 patients (84.2%) > or =65 years of age, and in 284 patients (84.5%) > or =75 years of age. The incidence of adverse events was similar in all age groups (18.0%, <65 years; 22.3%, > or =65 years; and 24.1%, > or =75 years), with no statistically significant differences between groups. Tolerability was rated as good or excellent in all patients, with no significant differences between groups. CONCLUSIONS: Once-daily amlodipine was effective in the treatment of mild to moderate hypertension in this patient population and demonstrated a low frequency of adverse events, a high degree of tolerability, and improved well-being. Morning rather than evening dosing appeared to confer a slight advantage.     

A multicenter, randomized, double-blind study of the antihypertensive efficacy and tolerability of irbesartan in patients aged > or = 65 years with mild to moderate hypertension

BACKGROUND: Blockade of the renin-angiotensin-aldosterone system (RAAS) is the preferred mechanism of action for controlling hypertension in select groups of patients, including those with diabetic nephropathy and heart failure. Currently, 2 classes of drugs work by blocking the RAAS, albeit by differing mechanisms: angiotensin-converting enzyme (ACE) inhibitors and angiotensin II angiotensin type 1 receptor blockers (ARBs). OBJECTIVE: The goal of this study was to assess the comparative efficacy and tolerability of the ARB irbesartan and the ACE inhibitor enalapril in patients > or = 65 years of age with mild to moderate hypertension (sitting diastolic blood pressure [DBP], 95 to 110 mm Hg). METHODS: Elderly (> or = 65 years of age) patients were recruited from 26 Canadian study centers for a randomized, double-blind, 8-week clinical trial. Exclusion criteria included sitting DBP >110 mm Hg or sitting systolic blood pressure (SBP) >200 mm Hg, angina pectoris, myocardial infarction, cardiac procedure, stroke, or transient ischemic attack within 6 months of randomization, as well as other preexisting or present severe medical or psychologic conditions. Patients were randomly assigned to receive a single daily dose of irbesartan 150 mg (n = 70) or enalapril 10 mg (n = 71) with treatment doses of study drugs doubled at week 4 for sitting DBP > or = 90 mm Hg. Reductions from baseline blood pressure measurements at trough (24 +/- 3 hours after the last dose of medication) were assessed for sitting DBP and sitting SBP. Comparative tolerability to study drugs was also assessed. RESULTS: The intent-to-treat analysis demonstrated similar reductions at week 8 in both DBP and SBP for both groups. For the primary efficacy analysis of sitting DBP, there was a mean reduction from baseline of 9.6 mm Hg and 9.8 mm Hg for the irbesartan and enalapril groups, respectively (P = 0.93). The mean reduction from baseline in sitting SBP was 10.1 mm Hg and 11.6 mm Hg for the irbesartan and enalapril groups, respectively (P = 0.54). Normalization rates (sitting DBP <90 mm Hg) at week 8 did not differ between groups (52.9% in the irbesartan group and 54.9% in the enalapril group; P = 0.81). No statistical difference existed between the 2 groups with respect to serious adverse events or discontinuations due to adverse events. Irbesartan was associated with a significantly lower incidence of cough than was enalapril (4.3% vs 15.5%, respectively; P = 0.046). CONCLUSIONS: Irbesartan is an effective and well-tolerated antihypertensive for elderly patients with mild to moderate hypertension. This study establishes that irbesartan has better tolerability than enalapril with respect to cough and suggests that irbesartan is as effective at lowering blood pressure but better tolerated than an ACE inhibitor in hypertensive patients > or = 65 years of age.     

Idiopathic thrombocytopenic purpura: preliminary results in patients aged >65 years

Sir, Idiopathic thrombocytopenic purpura (ITP) is often diagnosedin the elderly, but no specific guidelines exist for such patients.¹Recent studies report that patient age may influence both therapeuticresponse and treatment-associated toxicity.² We describe thepreliminary results of     

Retrospective study of the costs of care during the first year of therapy with etanercept or infliximab among patients aged > or =65 years with rheumatoid arthritis

OBJECTIVE: The aim of this work was to retrospectively examine the costs of therapy with etanercept and infliximab, among patients aged > or = 65 years with rheumatoid arthritis (RA), from a health-care system perspective. METHODS: Data from 2 large, automated US health-care claims databases (Constella COMPASS and Ingenix LabRx) were pooled for the analyses. Each database is comprised of paid facility, professional service, and retail (ie, outpatient) pharmacy claims from participating health plans. Using the 2 databases, all RA patients aged > =65 years were identified who began therapy with etanercept or infliximab between July 1, 1999 (Constella COMPASS), or January 1, 2001 (Ingenix LabRx), and December 31, 2002. Costs of RA-related care (including study drugs, selected medications, and outpatient encounters for RA) and non-RA-related care (all other medications and services) for patients in the 2 treatment groups were assessed, in US dollars, over a 1-year period after therapy initiation. RESULTS: A total of 280 RA patients aged > or = 65 years initiated therapy with etanercept (n = 99) or infliximab (n = 181) and met all other selection criteria. Etanercept patients were younger than infliximab patients (mean [SD] age, 70.5 [4.6] vs 71.8 [4.6] years; P = 0.04), were less likely to be enrolled in a managed care organization (76.7% vs 87.8%; P < 0.01), and had fewer pretreatment rheumatologist visits (mean [SD], 1.3 [2.3] vs 2.2 [3.8]; P = 0.04). Other characteristics, including pretreatment levels of other types of health-care utilization, were generally similar. Mean (95% CI) total cost of RA-related care was lower for etanercept patients in both databases (US 12,159 dollars [US 10,795 dollars-US 13,380 dollars] for etanercept vs US 22,347 dollars [US 20,808 dollars-US 23,912 dollars] for infliximab in one, and US 14,297 [US 12,238 dollars-US 16,326 dollars] for etanercept vs US 22,154 dollars [US 19,688 dollars-US 24,703 dollars] for infliximab in the other), primarily due to lower costs of anti-tumor necrosis factor therapy (US 10,015 dollars [US 8754 dollars-US 11,224 dollars] for etanercept vs US 18,611 dollars [US 17,169 dollars-US 20,023 dollars] for infliximab in one database; US 11,917 dollars [US 10,128 dollars-US 13,480 dollars] for etanercept vs US 16,759 dollars [US 14,551 dollars-US 19,062 dollars] for infliximab in the other). Mean (95% CI) costs of non-RA-related care were similar among etanercept and infliximab patients in both databases (US 13,100 dollars [US 8956 dollars-US 18,377 dollars] for etanercept vs US 11,789 dollars [US 8326 dollars-US 16,001 dollars] for infliximab in one, and US 16,665 dollars [US 10,329 dollars-US 25,690 dollars] for etanercept vs US 13,959 dollars [US 10,216 dollars-US 18,168 dollars] for infliximab in the other). CONCLUSION: These results suggest that costs of RA-related care during the first year of therapy may be lower among RA patients aged > or =65 years receiving etanercept versus infliximab, a difference attributable primarily to lower costs of drug acquisition.     

Eating difficulties, assisted eating and nutritional status in elderly (> or = 65 years) patients in hospital rehabilitation

This study describes frequencies and associations between eating difficulties, assisted eating and nutritional status in 520 elderly patients in hospital rehabilitation. Eating difficulties were observed during a meal and nutritional status was assessed with Subjective Global Assessment form. Eighty-two percent of patients had one or more eating difficulties, 36% had assisted eating and 46% malnutrition. Three components of eating were focused upon ingestion, deglutition, and energy (eating and intake). Deglutition and ingestion difficulties and low energy were associated with assisted eating, and low energy associated with malnutrition. Underestimation of low energy puts patients at risk of having or developing malnutrition.     

A multicenter, randomized, double-blind, retrospective comparison of 5- and 10-day regimens of levofloxacin in a subgroup of patients aged > or =65 years with community-acquired pneumonia

OBJECTIVE: This subgroup analysis sought to determine the efficacy and tolerability of a 5-day regimen of levofloxacin 750 mg/d compared with a 10-day regimen of levofloxacin 500 mg/d in the treatment of community-acquired pneumonia (CAP) in elderly patients (aged > or =65 years). METHODS: This subgroup analysis was based on the outcomes in patients aged > or =65 years from a randomized, double-blind, controlled trial conducted at 70 US centers. Patients in Pneumonia Severity Index (PSI) class I/II and III/IV were randomized to receive levofloxacin 750 mg/d for 5 days or levofloxacin 500 mg/d for 10 days. Study investigators assessed clinical and microbiologic outcomes 7 to 14 days after administration of the last dose of medication and collected adverse events for 30 days after the last dose. RESULTS: This analysis included 177 elderly patients, 80 receiving levofloxacin 750 mg/d for 5 days and 97 receiving levofloxacin 500 mg/d for 10 days. Although most demographic and baseline clinical characteristics were comparable between the 2 groups, the group that received levofloxacin 500 mg/d was older than the group that received levofloxacin 750 mg/d (median age, 76.0 vs 72.5 years, respectively; P = 0.029) and had a higher mean PSI score (90.7 vs 83.1; P = 0.017). Despite the halved duration of therapy, unadjusted clinical success rates were comparable between the 2 groups (89.0% and 91.9% in the 750- and 500-mg arms, respectively; 95% CI, -7.1 to 12.7). Microbiologic eradication rates were 90.3% (28/31) in the 750-mg arm and 87.5% (14/16) in the 500-mg arm (P = NS). Multivariate analysis adjusting for baseline PSI score indicated that treatment assignment was not statistically associated with clinical success (adjusted odds ratio for clinical success with 500-mg dose, 1.92; 95% CI, 0.62 to 5.99). The incidence of treatment-emergent adverse events did not differ between the 2 study treatments. The most common adverse events in both groups were insomnia, constipation, and headache. CONCLUSIONS: This subgroup analysis found that levofloxacin 750 mg/d for 5 days was well tolerated in the treatment of CAP in elderly patients. Undajusted and adjusted rates of clinical success were statistically similar between levofloxacin 750 mg/d for 5 days and levofloxacin 500 mg/d for 10 days.     

Efficacy and tolerability of cycletanine in aged patients with hypertension

Moderate arterial hypertension of the elderly has to be treated but the efficacy has to be progressive. Cicletanine has a pharmacokinetic profile well fitted to the therapy of this age group. The mechanism of action is characterized by synthesis of prostacyclin. A double blind prospective randomized study was conducted at two institutions on 132 patients aged more than 60, with diastolic arterial pressure over 95 mmHg and systolic over 160 mmHg. 62.9% of them were aged more than 75. The analysis of those two studies shows that the three groups with cicletanine (respectively 50, 100 and 150 mg per day) had a significant decrease of both pressures versus placebo. In the 50 mg group, 40% of arterial pressures were normalized after 3 months of treatment. There were no difference between 50 and 100 mg. There were no adverse drug reaction like falling down, day or night, or orthostatic hypotension. The biological tolerance, more particularly renal, was excellent with this dose of 50 mg a day. Cicletanine at the dose of 50 mg/day is a recommended treatment in arterial hypertension of the elderly.     

Analysis of the association between polypharmacy and socioeconomic position among elderly aged > or =77 years in Sweden

Background: Polypharmacy is an important patient safety concern and has been associated with increased adverse drug reactions, hospitalization, and mortality in the elderly. However, few studies have analyzed the association between socioeconomic position (SEP) and the extent of drug use in older people. Objectives: The aims of this study were to investigate the prevalence of polypharmacy and the association between polypharmacy and SEP, as measured by education, occupation, and income. Methods: For this cross-sectional study, data from a nationally representative sample (Swedish Panel Study of Living Conditions of the Oldest Old [SWEOLD] 2002) aged >/=77 years were analyzed (n = 621). Information on drug use was based on personal interviews, and polypharmacy was defined as concurrent use of >/=5 drugs. Other measurements included were age, sex, education, occupation, income, comorbidity, marital status, and living situation. The association between polypharmacy and SEP was assessed by logistic regression. Results: The mean number of drugs used in the sample was 4.4; in less educated patients, 4.6; more educated, 4.0. Polypharmacy was observed in 42.2% of the elderly. Overall, antithrombotic agents (42.5%), P-blocking agents (28.3%), and high-ceiling diuretics (28.0%) were the most prevalent drugs. Low education was associated with polypharmacy (odd ratio [OR], 1.46; 95% CI, 1.02-2.07), after controlling for age and sex. However, the association between low education level and polypharmacy was not significant after adjustment for age, sex, comorbidity, marital status, and living situation (OR, 1.39; 95% CI, 0.95-2.04). Moreover, we did not observe any association between occupation or income and polypharmacy. Conclusions: The results from this study suggest that >40% of people aged >/=77 years in Sweden are exposed to polypharmacy, defined as the use of >/=5 drugs. There was a higher prevalence of polypharmacy among elderly with low education. However, after controlling for comorbidity, martial status, and living situation, polypharmacy was not related to low education. Further studies in larger populations are needed to elucidate the association between SEP and drug use.     

Efficacy of 12-week monotherapy with arifon-retard of patients with isolated systolic hypertension

AIM: To evaluate the effect of arifon-retard (Servie, France) in patients with isolated systolic arterial hypertension (ISAH). MATERIAL AND METHODS: The efficiency of 12-week monotherapy with indapamid (arifon-retard) in a daily dose of 1.5 mg on systolic, diastolic, and pulse arterial pressure (SAP, DAP, and PAP, respectively) was studied in 20 patients with ISAH. RESULTS: SAP decreased by 25.1 +/- 1.8, (p < 0.00009), DAP by 4.2 +/- 0.9 (p < 0.0008), and PAP by 20.9 +/- 2.1 mm Hg (p < 0.00009). Antihypertensive effect was observed in all patients, AP normalized in 30% after 4 weeks of therapy and in 70% after 12 weeks, DAP not decreasing below 70 mm Hg in any of the patients. Antihypertensive effect of indapamid on SAP and PAP additionally increased from week 4 to week 12. With sufficient antihypertensive effect on SAP, the drug did not induce an excessive decrease of DAP and did not affect heart rate and blood biochemistry. The drug was well tolerated, no side effects were observed.     

缬沙坦与氨氯地平联合治疗高血压合并2型糖尿病伴尿微量白蛋白的临床研究

目的观察缬沙坦和氨氯地平联合应用对高血压合并2型糖尿病伴尿微量白蛋白的疗效以及安全性。方法将90例高血压合并2型糖尿病伴尿微量白蛋白患者随机分为A组、B组和C组,均为30例,A组在接受包括胰岛素、阿司匹林、阿托伐他汀等常规治疗的基础上加用缬沙坦胶囊,给药剂量为80 mg,po qd,B组在常规治疗的基础上加用氨氯地平片5 mg,po qd,C组在常规治疗的基础上联合应用缬沙坦胶囊(80 mg)和氨氯地平片(5 mg)。疗程6周,分别于治疗前后行动态血压检查,比较24 h、白天、昼夜平均收缩压、舒张压及血压变异性,血压达标率;测定尿微量白蛋白、血肌酐水平并观察不良反应发生率。结果 (1)治疗前三组患者24 h、白天、昼夜平均收缩压、舒张压、白天收缩压血压变异性(d SBPV)、白天舒张压血压变异性(d DBPV)、夜晚收缩压血压变异性(n SBPV)、夜晚舒张压血压变异性(n DBPV)及尿微量白蛋白、血肌酐等比较差异均无统计学意义(P>0.05);(2)治疗6周后三组24 h、白天、昼夜平均收缩压、舒张压均明显下降,与治疗前比较差异均有统计学意义(P<0.05),C组上述指标较A、B两组下降更明显,差异有统计学意义(P<0.05);B、C两组d SBPV、d DBPV、n SBPV、n DBPV均较治疗前显著降低(P<0.05),A组治疗前后上述指标差异无统计学意义(P>0.05);治疗后三组患者降压总有效率分别为50.0%、56.7%和90.0%,C组总有效率明显高于A、B两组,差异有统计学意义(P<0.05);(3)治疗后A、C两组尿微量白蛋白、血肌酐较治疗前均明显下降(P<0.05),B组治疗后上述指标虽有所下降,但差异无统计学意义(P>0.05);(4)三组患者不良反应总发生率分别为3.3%、6.7%、6.7%,差异无统计学意义(P>0.05)。结论缬沙坦联合氨氯地平可有效控制血压,降低血压变异性,同时能减少尿微量白蛋白,改善肾功能,且具有良好的安全性。     

Efficacy,safety, and tolerability of valsartan/hydrochlorothiazide in Asian patients with essential hypertension

Introduction  

Previous studies have demonstrated that hypertensive patients need concomitant therapy with one or more drugs from different classes of antihypertensive agents to achieve their blood pressure control targets. We performed the first multinational observational study of valsartan/hydrochlorothiazide (HCTZ) single pill combination in Asia to determine the efficacy, safety, and tolerability in hypertensive patients. The objective of this multinational, multicenter, 24-week follow-up observational study is to evaluate the efficacy, safety, and tolerability of valsartan/hydrochlorothiazide single pill combination in the treatment of essential hypertension in the Asia-Pacific region.     

Osmo-adalat in the treatment of isolated systolic and systolic-diastolic arterial hypertension in aged patients

AIM: To examine efficiency and tolerance of osmo-adalat in monotherapy of mild and moderate arterial hypertension (AH) in the elderly. MATERIAL AND METHODS: 60 AH patients were randomized into two groups. Group 1 received osmo-adalat monotherapy in daily dose 30 mg for 3 weeks. These were 14 patients with isolated systolic AH (ISAH) and 16 patients with essential hypertension (EH). Of group 2 patients, 15 with ISAH and 15 with EH received cordipin in a dose 10 mg three times a day. All the patients underwent 24-h monitoring of arterial pressure, in 18 patients arterial pressure and ECG were registered in parallel for 24 hours. RESULTS: AH treatment with osmo-adalat is rather effective. This is proved by its positive effect on shifted profile of arterial pressure in patients with ISAH and EH. A fall of arterial pressure on the peak of osmo-adalat antihypertensive action is not associated with hypotonic overloading of target organs, myocardial ischemia and increased heart rate. A single intake of osmo-adalat provides a smooth circadian control of arterial pressure in elderly hypertensive patients, the end effect being 50% of the peak one. The drug is well tolerated. Side effects do not require osmo-adalat discontinuation. CONCLUSION: Osmo-adalat in a single daily dose 30 mg is effective and safe in the treatment of mild and moderate AH in elderly patients.     

拜新同与北京降压0号或海捷亚合用治疗老年性单纯性收缩期高血压疗效观察

目的：观察和分析拜新同分别联合北京降压0号或海捷亚治疗老年性单纯性收缩期高血压（ISH）的疗效及对代谢的影响。方法：选择83例老年ISH患者随机分为3组，拜新同组（A组，n=28，拜新同30mg，1次／d），拜新同与北京降压0号合用组（B组，n=28，拜新同30mg，1次／d，北京降压0号1片，1次／d），拜新同与海捷亚合用组（C组，n=27，拜新同30mg，1次／d，海捷亚50mg，1次／d）。3组治疗疗程均为12周，观察3组治疗前后的血压及肝肾功能、血糖、血脂、电解质等指标的变化。结果：B、C组降压总有效率相当，其对随测血压、24h动态血压的控制疗效接近；B、C组血压控制效果明显优于A组；3组治疗前后心率及生化指标无明显改变。结论：拜新同与北京降压0号或海捷亚合用降低老年ISH均有较显著且相似的疗效．与单用拜新同比较效果更好。     

洛沙坦治疗老年收缩期高血压的临床观察

洛沙坦 (losartan,商品名科素亚 )是新型抗高血压药 ,通过阻断血管紧张素 受体 AT1 发挥降压作用。此药具有选择性高、副作用少 ,耐受性好等特点 ,临床应用日渐广泛 ,本文通过 2 4小时动态血压监测 ,观察其对老年高血压收缩期高血压(ISH)的疗效。结果报告如下1　对象和方法1.1　对象　选择 1998年 (下半年 )门诊或住院轻、中度 ISH5 3例 ,其中男 34例 ,女 19例 ;年龄 6 0～ 79岁 ,平均 (6 4.5±5 .6 )岁 ,均符合 WHO高血压诊断标准 , 期 2 3例 , 期 30例 ,病程 0 .5～ 31年 ,平均 (12± 7.5 )年 ,均经详细体检及血、尿、便常规、血压…     

Antihypertensive efficacy and tolerability of two fixed-dose combinations of valsartan and hydrochlorothiazide compared with valsartan monotherapy in patients with stage 2 or 3 systolic hypertension: an 8-week, randomized, double-blind, parallel-group trial

BACKGROUND: Combination therapy with at least 2 antihypertensive agents is usually needed to achieve appropriate blood pressure (BP) control in patients with isolated or predominant systolic hypertension. A currently recommended combination is a diuretic added to an angiotensin-receptor blocker. OBJECTIVE: This was a study of the effects on sitting systolic BP (SBP)of 2 combinations of valsartan and hydrochlorothiazide (HCTZ) compared with valsartan monotherapy in patients with stage 2 or 3 systolic hypertension (SBP > or =160 mm Hg and < or =200 mm Hg) with or without other cardiovascular risk factors. METHODS: After a placebo run-in period, patients were randomized to receive double-blind treatment with either valsartan 80 mg OD(monotherapy group) or valsartan 160 mg OD (combination-therapy groups) for 4 weeks, followed by forced titration to valsartan 160 mg OD (V160), valsartan 160 mg plus HCTZ 12.5 mg OD (V160 +HCTZ12.5), or valsartan 160 mg plus HCTZ 25 mg OD (V160 +HCTZ25) for an additional 4 weeks. End points were the change in SBP between the groups receiving combination therapy and the monotherapy group, between-group changes in diastolic BP (DBP), responder rates (SBP <140 mm Hg or a reduction in SBP of > or =20 mm Hg), and tolerability. RESULTS: A total of 774 patients were randomized to treatment: 261 to V160, 258 to V160+HCTZ12.5, and 255 to V160 +HCTZ25. The intent-to-treat population consisted of 767 patients (411 men, 356 women; mean age, 60 years; mean weight, 84 kg; clinic mean [SD] baseline BP, 167.5 [8.1]/93.4 [9.1] mm Hg). All treatments produced significant reductions in SBP from baseline (mean [SD] reduction, 20.7 [15.7] mm Hg with V160, 27.9 [13.8] mm Hg with V160 +HCTZ12.5, and 28.3 [13.1] mm Hg with V160+HCTZ25; all, P < 0.05). DBP was reduced by 6.6 (8.9) mm Hg in the V160 group and by 10.2 (7.7) and 10.1 (7.8) mm Hg in the V160+HCTZ12.5 and V160 +HCTZ25 groups, respectively (all, P < 0.05). The additional reductions in BP with V160+HCTZ25 did not reach statistical significance compared with V160+HCTZ12.5. Responder rates were 56.9% in the V160 group, 74.4% in the V160+HCTZ12.5 group, and 75.0% in the V160 +HCTZ25 group P < 0.05, combination therapy vs monotherapy). Adverse events were reported by 27.5% of patients in the monotherapy group, compared with 28.6% and 34.0% in the groups that received V160+HCTZ12.5 and V160+HCTZ25, respectively; the differences were not significant between treatment groups. CONCLUSIONS: Monotherapy with V160 was effective in these patients with stage 2 or 3 systolic hypertension. Significant additional reductions in SBP and DBP and an increase in responder rates were achieved with the addition to V160 of HCTZ12.5 and HCTZ25, with no significant effect on tolerability.