动态血压监测评价甲磺酸氨氯地平的降压疗效

目的:应用动态血压监测(ABPM)评价甲磺酸氨氯地平的降压疗效,并与苯磺酸氨氯地平进行比较。方法:77例高血压患者按不同的治疗药物随机分为甲磺酸氨氯地平组、苯磺酸氨氯地平组,均治疗12周,治疗前后测定动态血压、心率、诊室血压、生化指标。结果:治疗12周末,2组的诊室血压,24h、白昼及夜间平均血压、平均脉压、血压负荷均显著降低(P<0·05或P<0·01),心率无显著改变。12周末甲磺酸氨氯地平组的总有效率在诊室血压为92·3%,在ABPM为71·8%;苯磺酸氨氯地平组分别为92·1%和68·4%,2组间均差异无统计学意义。甲磺酸氨氯地平组收缩压和舒张压的24h降压谷/峰比分别为70%和72%;苯磺酸氨氯地平组分别为66%和69%。2组患者出现的不良反应均轻微。结论:甲磺酸氨氯地平与苯磺酸氨氯地平一样能平稳、有效、安全地降低血压,可作为一线降压用药。     

Effects of telmisartan 80 mg and valsartan 160 mg on ambulatory blood pressure in patients with essential hypertension

OBJECTIVES: This trial investigated and compared the antihypertensive efficacy of telmisartan and valsartan, two angiotensin II receptor blockers, used in monotherapy at their maximum recommended dose in hypertensive patients. METHODS: We studied 70 subjects (32 men and 38 women) aged 47.6 +/- 12.2 (mean +/- SD) years, with mild to moderate essential hypertension; they were randomly assigned to receive monotherapy with either telmisartan (80 mg) or valsartan (160 mg), in the form of a single daily tablet upon awakening. Blood pressure was measured by ambulatory monitoring every 20 min during the day and every 30 min at night for 48 consecutive hours before and after 3 months of treatment. Physical activity was simultaneously monitored every minute by wrist actigraphy to calculate accurately the diurnal and nocturnal means of blood pressure on a per subject basis. RESULTS: There was a highly significant blood pressure reduction during the 24 h with both drugs. The blood pressure reduction in the 24-h mean was significantly larger for valsartan 160 mg (18.6 and 12.1 mmHg for systolic and diastolic blood pressure, respectively) than for telmisartan 80 mg (10.8 and 8.4 mmHg; P < 0.001 between treatment-groups). There was also a highly significant reduction (P < 0.001) of 6.5 mmHg in the 24-h mean of pulse pressure after valsartan administration only. The trough : peak ratio and the smoothness index were slightly higher in systolic, but similar in diastolic blood pressure, for telmisartan as compared to valsartan. CONCLUSIONS: Despite a shorter half-life, 160 mg/day valsartan was more effective in lowering blood pressure over 24 h than 80 mg/day telmisartan. Furthermore, valsartan was also more effective in lowering arterial pulse pressure, an observation that may have important therapeutic implications, given the mounting evidence that pulse pressure may be a risk factor for future cardiovascular events.     

动态血压观察卡维地洛降压疗效

目的 :观察卡维地洛的降压疗效。方法 :服用安慰剂 10～ 14 d后服用卡维地洛 10～ 40mg/ d,上午 8时顿服 ,总疗程为 4周 ,共治疗轻中度原发性高血压 ( EH)患者 2 5例。采用血压监测仪测定 2 4h动态血压。结果 :治疗 4周后 2 4h平均血压、白昼及夜间平均血压、血压负荷值均较用药前显著下降 ( P <0 .0 1) ,收缩压和舒张压的谷 /峰比值分别降低 5 4.1%和 65 .6%。结论 :卡维地洛每日 1次投药能有效地控制轻中度 EH患者 2 4h血压水平。     

氯沙坦钾降压效果的动态血压分析

目的 :观察新型血管紧张素 受体拮抗剂氯沙坦钾的降压疗效。方法 :42例原发性高血压 (EH)患者每天服用氯沙坦钾 50 mg,疗程 4～ 8周 ,均以 2 4 h动态血压作为监测及评价方法。结果 :2 4 h收缩压和舒张压均明显下降 (P <0 .0 1 ) ,收缩压谷峰比 =70 % ,舒张压谷峰比 =52 % ,对夜间血压不产生过度降压作用 ,且对血糖、血脂、血尿酸无不良影响 ,副反应发生率低。结论 :每日服用 50 mg氯沙坦钾对 EH有 2 4 h平稳降压作用     

A prospective, randomized, open-label trial comparing telmisartan 80 mg with valsartan 80 mg in patients with mild to moderate hypertension using ambulatory blood pressure monitoring

OBJECTIVE: To compare the antihypertensive efficacy and tolerability of telmisartan 80 mg with valsartan 80 mg throughout a 24 h dosing interval. DESIGN: A prospective, randomized, open-label, blinded end point, parallel group study. Treatment efficacy was compared using ambulatory blood pressure monitoring (ABPM), cuff sphygmomanometry and calculated responder rates. Tolerability was assessed by physical examination, laboratory parameters, 12-lead electrocardiogram, blood pressure and heart rate monitoring, and evaluation of adverse events. SETTING: Thirty-five centres in the United States. PATIENTS: Four hundred and twenty-six patients with mild to moderate essential hypertension entered the study. Ninety-two per cent (n=393) completed the study. INTERVENTIONS: Patients underwent a four-week, single-blind, placebo run-in period before being randomly assigned to once-daily oral telmisartan 80 mg (n=214) or valsartan 80 mg (n=212) for an eight-week, open-label treatment period. RESULTS: Treatment with telmisartan was associated with a significantly greater mean reduction from baseline in the last 6 h ABPM mean for diastolic blood pressure compared with the valsartan-treated group (-7.5+/-0.6 mmHg versus -5.2+/-0.6 mmHg, respectively, P<0.01). Secondary analyses showed significantly greater efficacy with telmisartan 80 mg than with valsartan 80 mg, including greater mean reductions from baseline of ABPM (systolic blood pressure and diastolic blood pressure) during the daytime (06:00 to 21:59) and morning (06:00 to11:59) hours, and larger decreases in trough cuff blood pressure (P<0.01). Both treatments showed placebo-like tolerability profiles. CONCLUSIONS: Telmisartan 80 mg once daily was superior to valsartan 80 mg once daily in reducing diastolic blood pressure during the last 6 h of the 24 h dosing interval. These results may be due to telmisartan's longer plasma half-life or to a higher potency compared with valsartan, such that a higher dose of valsartan may produce effects similar to those of 80 mg telmisartan. These data confirm the long duration of action of telmisartan with consistent and sustained control of blood pressure over 24 h and during the last 6 h of the dosing interval. Both treatments were well tolerated; the adverse event data confirmed the excellent tolerability profiles of telmisartan and valsartan that have been reported previously.     

Clinical characteristics of resistant hypertension evaluated by ambulatory blood pressure monitoring

Strict control of blood pressure is important to prevent cardiovascular disease, although it is sometimes difficult to decrease blood pressure to target levels. The aim of this study was to investigate the clinical characteristics of resistant hypertension evaluated by ambulatory blood pressure monitoring. One hundred in-hospital patients, whose 24-hour average blood pressure was higher than 130/80?mmHg even after treatment with more than three antihypertensive drugs, were included in the present analysis. Circadian variation of blood pressure was evaluated by nocturnal fall in systolic blood pressure. Average blood pressures of all patients were high in both daytime and nighttime, 150.0/82.9 and 143.8/78.2?mmHg, respectively. Twenty patients had been treated with hemodialysis or peritoneal dialysis. In 63 patients out of the other 80 patients (79%), estimated glomerular filtration rate (eGFR) was also decreased (<60?mL/min/1.73 m²). The patients classified into dipper, non-dipper, riser and extreme-dipper were 20%, 43%, 34% and 3%, respectively. In addition, in 17 patients whose eGFR was preserved, 12 patients showed a non-dipper or riser pattern, suggesting that it was difficult to account for this altered circadian blood pressure variation only by renal dysfunction. These results show that a large number of the patients with resistant hypertension suffered from renal dysfunction, although it was difficult to explain altered circadian blood pressure variation based on renal dysfunction alone.     

动态血压监测对老年体位性低血压评价的探讨

目的探讨动态血压监测（ABPM）技术对老年体位性低血压的评价价值。方法对152例门诊老年人进行卧位及立位3min血压测量,根据血压变化将患者分为体位性低血压组及非体位性血压组。对所有患者进行动态血压监测,计算并比较两组全天、白天以及夜间的平均血压、平均脉压、血压负荷、血压变异系数、动态动脉硬化指数以及24h血压昼夜节律。结果体位性低血压组的夜间平均收缩压、夜间平均舒张压、夜间收缩压负荷、夜间舒张压负荷、全天收缩压变异系数均高于非体位性低血压组,血压昼夜节律以反杓型为主。结论动态血压监测在老年体位性低血压的用药指导中有着重要的临床作用;老年体位性低血压存在夜间高血压、卧位高血压、收缩压波动范围大、血压昼夜节律异常的特点,上述特征均可造成重要靶器官的损伤。     

Comparison of the antihypertensive effects of the fixed dose combination enalapril 10 mg/nitrendipine 20 mg vs losartan 50 mg/hydrochlorothiazide 12.5 mg, assessed by 24-h ambulatory blood pressure monitoring, in essential hypertensive patients

Fixed combinations of calcium channel blockers and angiotensin converting enzyme inhibitors represent an alternative to diuretic-based combination therapy. The aim of the present study was to compare the antihypertensive efficacy of the combination enalapril 10 mg/nitrendipine 20 mg (E/N) vs losartan 50 mg/hydrochlorothiazide 12.5 mg (L/H), assessed by 24-h ambulatory blood pressure monitoring. This multicentre, double-blind, parallel study included 97 hypertensive patients (office diastolic blood pressure (DBP) 90-109 mmHg and daytime DBP > 85 mmHg). After a 2- to 3-week period of single-blind placebo, they were randomized to receive double-blind treatment with E/N (n = 48) or L/H (n = 49) for a 4-week period. The primary outcome measure was the difference in 24-h DBP reduction between treatments from randomization to the end of the double-blind period. Secondary efficacy variables included differences in 24-h systolic (S) BP reduction, daytime, night-time and office SBP and DBP reduction, proportion of responders and controlled patients, trough-to-peak ratio and smoothness indexes. Safety was assessed by the proportion of patients with adverse events and the detection of laboratory abnormalities. No significant differences were observed in the primary outcome measure. The group receiving E/N tended to show greater reductions in most measures (24 h, daytime and office SBP and DBP) and higher BP control rates, but only the difference in the rate of office SBP control (< 140 mmHg) reached statistical significance (42.2 vs 22.4%; P = 0.048). The trough-to-peak ratios and smoothness indexes were similar in both groups. The incidence of adverse events related to the treatment was 27.1% (95% CI 14.5-39.6%) in E/N-treated patients and 14.3% (95% CI 4.5-45.8%) in the L/H group, but differences were not significant. The kind of event more frequently observed were flushing and headache in E/N, and dizziness and asthenia in L/H; all observed adverse events were mild. We conclude that E/N and L/H have a similar antihypertensive efficacy, assessed by office or ambulatory blood pressure monitoring. E/N achieved a significantly higher office SBP control rate, but this was accompanied by an apparently higher proportion of mild adverse events.     

Comparative effects of valsartan plus either cilnidipine or hydrochlorothiazide on home morning blood pressure surge evaluated by information and communication technology–based nocturnal home blood pressure monitoring

The authors tested the hypothesis that a valsartan/cilnidipine combination would suppress the home morning blood pressure (BP) surge (HMBPS) more effectively than a valsartan/hydrochlorothiazide combination in patients with morning hypertension, defined as systolic BP (SBP) ≥135 mm Hg or diastolic BP ≥85 mm Hg assessed by a self‐measuring information and communication technology–based home BP monitoring device more than three times before either combination''s administration. This was an 8‐week prospective, multicenter, randomized, open‐label clinical trial. The HMBPS, which is a new index, was defined as the mean morning SBP minus the mean nocturnal SBP, both measured on the same day. The authors randomly allocated 129 patients to the valsartan/cilnidipine (63 patients; mean 68.4 years) or valsartan/hydrochlorothiazide (66 patients; mean 67.3 years) combination groups, and the baseline HMBPS values were 17.4 mm Hg vs 16.9 mm Hg, respectively (P = .820). At the end of the treatment period, the changes in nocturnal SBP and morning SBP from baseline were significant in both the valsartan/cilnidipine and valsartan/hydrochlorothiazide groups (P < .001): −5.0 vs −10.0 mm Hg (P = .035) and −10.7 vs −13.6 mm Hg (P = .142), respectively. HMBPS was significantly decreased from baseline in both groups (P < .001), but there was no significant difference between the two groups: 14.4 mm Hg vs 14.0 mm Hg, respectively (P = .892). Valsartan/cilnidipine could not significantly suppress HMBPS compared with valsartan/hydrochlorothiazide. Large‐scale randomized controlled studies are needed to assess how reducing HMBPS will affect future cardiovascular outcomes. The information and communication technology–based home BP monitoring device may become an alternative to ambulatory BP monitoring, which has been a gold standard to measure nocturnal BP and the morning BP surge.     

Antihypertensive treatments: drug efficacy effect and initial ambulatory blood pressure

OBJECTIVE: we used initial whole day blood pressure (BP) level to evaluate antihypertensive therapy in different class of agents. DESIGN AND METHODS: The study was performed with 205 hypertensive patients. All patients had essential mild to moderate hypertension after single-blind placebo run in period. At the end of this period, and after 1 month of active treatment (3 class of agents: angiotensin converting enzyme inhibitors (ACEI) = 117, calcium channel blockers (CCB) = 52, beta-blockers (BB) = 36) casual blood pressure was performed and ambulatory BP was monitored during the whole day. At the start of the study, 91 of 205 patients had an ambulatory diastolic BP less than to 90 mmHg (group I: "normotensive patients") and 114 greater than or = 90 mmHg (group II: "hypertensive patients"). Clinical measurements and whole day BP monitoring are used to assess response to treatment for all patients and for the group I and II. RESULTS: Therapy decreased clinical BP by 19 +/- 15/11 +/- 9 mmHg and average whole day BP by 10 +/- 11/7 +/- 8 mmHg. In the 3 class of agents, there is no difference between group I and II at the start of study. ACEI treatment: In group I, decrease of average whole-day BP by 12/7 and by 11/8 mmHg in group II. In contrast for CCB treatment: 2/2 and 13/7 (p less than 0.001), for BB treatment 10/4 and 13/11. In the 3 class of agents, there is no difference in the clinical BP decreases between group I and II. CONCLUSION: Our data emphasize a significant discrepancy between clinical and ambulatory BP evaluation among patients displaying low ambulatory BP particularly with CCB treatment in contrast with ACEI treatment. In the low group, CCB decreased ambulatory BP less than ACEI did. These results suggest that there is a lesser chance of overtreating "normotensive" patients with CCB than there is with ACEI.     

The placebo effect in ambulatory blood pressure monitoring

The reduction of clinic blood pressure by placebo tablets in clinical trials of antihypertensive drugs is well established and health authorities require a placebo arm in these trials in order to know how much of the total reduction of blood pressure is attributable to the drug. Most authors now favor the hypothesis that, in contrast to clinic blood pressure measurements, ambulatory blood pressure monitoring (ABPM) is not subject to a placebo effect. Scientific evidence so far shows that ABPM recordings are affected by a negligible and clinically irrelevant placebo effect in short-term trials. Nevertheless, the results of the SYST-EUR study suggest that placebo treatment induces a reduction of blood pressure in old patients with isolated systolic hypertension even when blood pressure is measured by 24 h ABPM, and raise the question of whether a placebo arm is required in clinical trials when ABPM is used to measure changes in blood pressure. In this article, the evidence supporting and contradicting the hypothesis that placebo exerts an effect on ABPM and the possible explanations for the discrepancy are reviewed. My position is that clinical trials on antihypertensive drugs using ABPM should be designed with the same standards as those using clinic blood pressure measurements; that is, randomized, double-blind, placebo-controlled studies. This should be an absolute requirement in long-term trials. Short-term trials lasting no more than 12 weeks, particularly those focused on examining average changes in 24 h diastolic blood pressure, may be designed without a placebo arm.     

24-Hour ambulatory blood pressure response to combination valsartan/hydrochlorothiazide and amlodipine/hydrochlorothiazide in stage 2 hypertension by ethnicity: the EVALUATE study

Several studies reported racial/ethnic differences in blood pressure (BP) response to antihypertensive monotherapy. In a 10-week study of stage 2 hypertension, 320/25 mg valsartan/hydrochlorothiazide (HCTZ) reduced ambulatory BP (ABP) significantly more effectively than 10/25 mg amlodipine/HCTZ. Results (post hoc analysis) are described in Caucasians (n=256), African Americans (n=79), and Hispanics (n=86). Compared with clinic-measured BP (no significant treatment-group differences in ethnic subgroups), least-squares mean reductions from baseline to week 10 in mean ambulatory systolic BP (MASBP) and mean ambulatory diastolic BP (MADBP) favored valsartan/HCTZ over amlodipine/HCTZ in Caucasians (-21.9/-12.7 mm Hg vs -17.6/-9.5 mm Hg; P=.0004/P<.0001). No treatment-group differences in MASBP/MADBP were observed in African Americans (-17.3/-10.6 vs -17.9/-9.5; P=.76/P=.40) or Hispanics (-17.9/-9.7 vs -14.2/-7.2; P=.20/P=.17). Based on ABP monitoring, valsartan/HCTZ is more effective than amlodipine/HCTZ in lowering ABP in Caucasians. In African Americans and Hispanics, both regimens are similarly effective.     

24小时动态血压监测厄贝沙坦降压效果

目的　评价24小时动态血压监测(ABPM)厄贝沙坦降压效果。　方法　选择1级至2级原发性高血压患者45例给予厄贝沙坦150mg每日一次,早晨7∶00口服,共4周。ABPM用药前后24小时血压变化情况。　结果　厄贝沙坦治疗后24小时血压显著下降(P<005),总有效率为82%,白天与夜间血压下降幅度大致相同,保持正常血压昼夜节律变化。　结论　厄贝沙坦对1~2级高血压是较为理想的药物。     

Evaluation of the antihypertensive effect of celiprolol by ambulatory blood pressure monitoring

The use of ambulatory blood pressure monitoring has gained popularity because it is not subject to those limitations associated with traditional sphygmomanometry (inaccuracy of blood pressure readings, low number of readings, and failure to represent daytime blood pressure readings). In the present study, we provide evidence that the 24-hour mean blood pressure obtained through intraarterial blood pressure measurements in ambulatory patients provides a more accurate diagnosis (and perhaps a prognosis) of hypertension than that provided by cuff-obtained casual blood pressure measurement. Furthermore, despite a reduction in the amount and in the accuracy of the information obtained, blood pressure data provided by noninvasive blood pressure monitoring are also more accurate diagnostically than cuff-obtained casual blood pressure measurements. In 15 essential hypertensive patients in whom celiprolol, 400 mg once daily, was compared with placebo in a randomized double-blind crossover study, the use of noninvasive 24-hour automatic blood pressure monitoring showed that in responsive patients, celiprolol induced a sustained reduction in systolic and diastolic blood pressure throughout the 24 hours. The blood pressure reduction was also apparent during the night, despite the concomitant occurrence of a slight tachycardia. These findings demonstrate that once-daily administration of celiprolol provides an effective lowering of the 24-hour blood pressure profile. This dosing schedule can therefore be regarded as appropriate for antihypertensive therapy.     

Antihypertensive effect of isradipine administered once or twice daily on ambulatory blood pressure

The antihypertensive efficacy of sustained-release isradipine administered once daily compared to the immediate-release formulation administered twice daily was assessed by ambulatory blood pressure (BP) monitoring in a double-blind randomized crossover study in 76 mild-to-moderate hypertensive patients. Conventional BP and heart rate parameters were evaluated after a 4-week placebo period and patients qualified for entry if sitting diastolic BP was between 95 and 114 mm Hg. Ambulatory BP monitoring was measured at baseline and after active treatment with both formulations. The 2 regimens induced a significant and almost identical reduction (p less than 0.001) in the mean 24-hour BP without affecting heart rate. Isradipine was more effective in patients whose clinical hypertension was confirmed by ambulatory BP monitoring (35) than in patients who remained normotensive by ambulatory BP monitoring criteria (41). The isradipine-treated ambulatory hypertensive group experienced significantly greater decreases in BP during 24-hour, work, awake and sleep periods than did the ambulatory normotensive group. These data suggest that sustained-release isradipine has a sustained antihypertensive effect throughout 24 hours comparable to that of isradipine given twice daily and may improve compliance with long-term treatment. In addition, the results confirm the usefulness of ambulatory BP monitoring in determining truly hypertensive patients likely to respond to drug administration.