Comparison of the effects of felodipine and cilazapril on exercise performance in patients with mild to moderate hypertension. A crossover study

This double-blind crossover study was designed to compare the effects of felodipine and cilazapril on exercise performance in hypertensive patients. After a 2-week placebo run-in period, 40 patients with mild to moderate hypertension were randomized into two parallel groups to receive either felodipine (10 mg) or cilazapril (5 mg) for 4 weeks. After another 2-week washout period, treatments were then crossed over for a further 4-week study period. All patients were given an extensive rest and exercise evaluation at the end of the placebo period. Extensive rest and exercise evaluations were repeated after a 4-week treatment period and again after the second washout period and after the second 4-week treatment period. Before each exercise test, epinephrine, norepinephrine and dopamine plasma levels and plasma renin activity were measured. Two groups were similar at baseline for systolic and diastolic blood pressure and heart rate as well as for laboratory and hormonal variables and duration of exercise test. At the end of treatment diastolic blood pressure was significantly reduced in the felodipine group (p = 0.019). Duration of exercise test was longer than at baseline (p = 0.031) in the felodipine group. Plasma dopamine levels were significantly increased in the cilazapril group. Plasma renin activity significantly increased in the felodipine group. In conclusion, our data show that the two drugs have the same effectiveness in resting conditions but that felodipine is more effective in lowering maximum exercise diastolic blood pressure and in improving exercise time with an double product increase (not significant); it has no statistically significant effect on maximal exercise systolic blood pressure.     

有氧运动对乳腺癌化疗患者癌因性疲乏的影响及相关机制

摘要： 目的 探讨有氧运动对乳腺癌化疗患者癌因性疲乏的影响及相关机制。方法 60 例根治术术后欲进行化疗的乳腺癌患者随机分为运动组和对照组, 各 30 例。对照组给予常规护理。运动组除常规护理外, 在化疗第 1 天开始有氧运动干预, 直到化疗结束。使用 Piper 疲乏修订量表 （RPFS） 对疲乏程度进行评估。分别在化疗前、 化疗结束和化疗后 4 周检测两组患者的血红蛋白 （Hb） 水平、 最大摄氧量 （VO2max ） 和 RPFS 得分情况。结果 两组 Hb 水平在化疗前、 化疗结束和化疗后 4 周差异均无统计学意义 （P＞0.05）; 化疗结束和化疗后 4 周, 两组 Hb 水平均低于化疗前 （P＜0.05）。化疗前两组 VO2max 和 RPFS 得分差异无统计学意义 （P＞0.05）; 化疗结束和化疗后 4 周, 运动组 VO2max 和 RPFS 得分与化疗前相比差异均无统计学意义 （P＞0.05）, 对照组 VO2max 低于化疗前水平, RPFS 得分高于化疗前水平 （均 P＜0.05）。结论 化疗期间有氧运动能够有效缓解化疗导致癌因性疲乏加重的情况, 这可能与有氧运动能对抗 VO 降低有关。     

CROSSOVER COMPARISON BETWEEN THE DEPRESSOR EFFECTS OF LOW AND HIGH WORK-RATE EXERCISE IN MILD HYPERTENSION

1. The relationship between work-rate and the antihypertensive effect of exercise in hypertensives, and the mechanism of that effect, were investigated by a crossover clinical trial. 2. Ten mild hypertensives were randomly divided into two groups. One group performed low work-rate exercise (LWE) on a cycle ergometer for 10 weeks (blood lactate threshold; ～50% of maximum oxygen consumption [V?_O2max]). After a 10 week interval without exercise training, these subjects were then switched to a high work-rate exercise (HWE) regimen (4 mmol/ L of blood lactate; ～75% of V?_O2max) for another 10 weeks. In the other group, the order of exercise training was reversed. Since two patients withdrew from the protocol during HWE periods, statistical analysis was performed on the data from the remaining eight patients. There were no order effects observed in any of the data from the two groups. 3. During both LWE and HWE, resting blood pressure (BP) fell significantly after the initiation of exercise therapy (P<0.05). Furthermore, the overall effects of 10 weeks of LWE and HWE on BP were not significantly different. 4. The work-rate at the lactate threshold, which reflects physical fitness, had increased significantly by 16 W (P<0.01) after the LWE period and by 11 W (P<0.01) after the HWE. 5. During the LWE period, changes in haemodynamic and humoral variables were not significant, except for a reduction in plasma norepinephrine at week 10 (P<0.05). In the HWE period, changes in haemodynamic and humoral variables were not significant. 6. Based on these findings, LWE is recommended for mild hypertensives because of its safety.     

A RANDOMIZED CONTROLLED TRIAL OF WEIGHT REDUCTION AND METOPROLOL IN THE TREATMENT OF HYPERTENSION IN YOUNG OVERWEIGHT PATIENTS

The effects of weight reduction and metoprolol (100 mg, b.d.) in the treatment of hypertension (diastolic blood pressure 90-109 mmHg) in 56 young, overweight patients were investigated in a randomized placebo controlled trial. After a 4-week baseline, subjects were followed up for 21 weeks. In the weight reduction group, the fall in systolic and diastolic blood pressure (13/10 mmHg), associated with a mean group weight loss of 7.4 kg, was greater (P less than 0.001) than that in the placebo group (7/3 mmHg); the fall in diastolic pressure but not systolic pressure was also greater than that in the metoprolol group (10/6 mmHg). At the end of follow-up, 50% of the weight reduction group, 39% of the metoprolol group and 17% of the placebo group had a diastolic blood pressure of less than 90 mmHg. In the weight reduction group there was a fall in total cholesterol and the ratio of total to HDL-cholesterol (P less than 0.001); in the metoprolol group there was a fall in HDL-cholesterol and an increase in the ratio of total to HDL-cholesterol (P less than 0.001). The results suggest that in the first step of treatment for hypertension in overweight patients, modest weight reduction produces significant and clinically important reductions in blood pressure, without incurring the adverse effects on plasma lipids and lipoproteins often associated with the first step of drug therapy.     

Efficacy and tolerability of amlodipine in patients with mild-to-moderate hypertension.

Twenty-one subjects with mild or moderate systemic hypertension were treated for 12 weeks with amlodipine, a new calcium antagonist of the dihydropyridine group. Initial amlodipine dose was 5 mg once daily, but the dose could be increased after four or eight weeks to 10 mg once daily if diastolic blood pressure was not less than or equal to 90 mmHg (12.0 kPa). At the end of the study, a substantial reduction of systolic blood pressure (20 mmHg-2.7 kPa-from baseline) and diastolic blood pressure (14 mmHg-1.9 kPa-from baseline) was observed. Statistically significant changes in systolic and diastolic blood pressure were produced after four weeks of treatment. There were no statistically significant changes in heart rate throughout the study. Six patients with mild and five patients with moderate hypertension became normotensive after amlodipine treatment (64%). Two with mild hypertension finished the trial without change in hypertensive status, and four with initially moderate hypertension changed to mild at the end of the study. Only one patient dropped out due to an adverse reaction, two adverse events were rated severe, but did not require discontinuation. Overall impressions of efficacy were excellent or good in two-thirds of cases and poor in 10%; overall impressions of toleration were excellent or good in 71% of cases and poor in 10%. It is concluded that amlodipine is useful and well tolerated in patients with mild or moderate hypertension.     

A CONTROLLED STUDY OF THE EFFECTS OF AEROBIC EXERCISE ON ANTIHYPERTENSIVE DRUG REQUIREMENTS OF ESSENTIAL HYPERTENSIVE PATIENTS IN THE GENERAL PRACTICE SETTING

1. To investigate the effect of an exercise training programme on antihypertensive drug requirements, 19 sedentary subjects (14 men and five women) with mild essential hypertension (systolic blood pressure greater than 140 mmHg but less than 180 mmHg), aged 29-55 years, were randomly assigned to 16 weeks of moderate intensity exercise or light intensity exercise (control), and titrated on antihypertensive drug therapy (captopril and hydrochlorothiazide) until resting systolic blood pressure (sitting) of less than 140 mmHg was achieved. 2. The moderate exercise group (n = 11) followed a graded walk-jog programme to greater than 60% age-predicted maximum heart rate (HRmax), attending 45 min sessions, three times each week. The light exercise group (n = 8) followed a programme of flexibility (stretching exercises) and walking to less than 60% age-predicted HRmax, attending 45 min sessions, three times each week. 3. There was no difference between treatment groups for the level of reduction in both resting systolic and diastolic blood pressure over the 16 weeks (15.64 +/- 10.6/12.81 +/- 9.97 mmHg in the moderate intensity group and 15.31 +/- 10.9/7.7 +/- 7.1 mmHg in the light intensity group). The change in 24 h ambulatory blood pressure profile was also similar in both treatment groups. The final antihypertensive drug requirements to achieve these changes in blood pressure was not significantly different between the two treatment groups. This was despite a significant improvement in submaximal exercise performance in the moderate intensity exercise group (P less than 0.001). 4.(ABSTRACT TRUNCATED AT 250 WORDS)     

Effects of ibopamine on exercise-induced increase in norepinephrine in normal men.

The effects of 100 mg ibopamine, an orally active aselective dopamine (DA) agonist, on plasma catecholamines was evaluated in 8 healthy men during sympathetic stimulation by graded exercise in a single-blind, placebo-controlled cross-over study. The exercise consisted of progressive cycling activity less than or equal to 90% of the previously determined VO2max. Graded exercise resulted in an increase in systolic and mean blood pressure (SBP, MBP), heart rate, norepinephrine (NE) and epinephrine level, with a decrease in diastolic BP (DBP). The increase in NE was significantly blunted by ibopamine as compared with placebo. No differences for BP, heart rate (HR), or epinephrine between placebo- and ibopamine study day were noted. In previous studies, ibopamine decreased resting plasma NE in patients with congestive heart failure (CHF), whereas plasma NE was not altered by ibopamine in healthy volunteers. This different outcome in both categories might therefore be explained by the absence of substantial sympathetic stimulation in normal humans at rest. Because it is reasonable to assume that the effect of ibopamine on systemic and local hemodynamics is negligible as compared with the effect of exercise in the healthy volunteers, the plasma decrease caused by ibopamine is probably related to stimulation of DA2-receptors. In conclusion, ibopamine blunts the increase of plasma NE during graded exercise in healthy men.     

Fosinopril reduces left ventricular mass in untreated hypertensive patients: a controlled trial

AIMS: Left ventricular hypertrophy is a powerful predictor of cardiovascular morbidity and mortality. We tested the hypothesis that fosinopril, an angiotensin-converting enzyme inhibitor, reduces left ventricular mass in hypertensive patients. METHODS: Thirty-three patients with untreated mild essential hypertension were randomised to treatment with oral fosinopril (10 mg-20 mg daily) or placebo for 12 weeks. The primary outcome measure was the change in left ventricular mass index determined by echocardiography. RESULTS: Diastolic blood pressure changed from 95.5+/-2.1 mmHg at baseline to 96.6+/-2.8 mmHg at the final visit in control patients and changed from 96.6+/-2.3 mmHg to 91.5+/-3.0 mmHg in patients treated with fosinopril (P= 0.04). Systolic blood pressure changed from 147.4+/-3.2 mmHg at baseline to 152.7+/-4.4 mmHg at the final visit in control patients and changed from 157.6+/-5.1 mmHg to 149.1+/-6.1 mmHg in patients treated with fosinopril (P=0.02). Fosinopril reduced diastolic pressure by 6.3 (95%CI 0.3-12.4) mmHg and systolic pressure by 13.3 (95%CI 2.7-23.8) mmHg compared with placebo. The left ventricular mass index changed from 110.0+/-8.3 gm(-2) to 113.1+/-8.7 g m(-2) in the control patients and changed from 120.8+/-5.8 g m(-2) to 109.0+/-7.5 g m(-2) in patients treated with fosinopril (P=0.02). Fosinopril reduced left ventricular mass index by 14.9 (95%CI 2.2-27.6) g m(-2) compared with placebo. There was no significant change in the left ventricular systolic or diastolic function, nor were there any significant changes in plasma electrolytes and renal function. CONCLUSIONS: Treatment with fosinopril for 12 weeks reduced left ventricular mass significantly in hypertensive patients.     

Felodipine extended release in mild to moderate hypertension

A multi-centre study was carried out to examine the antihypertensive effect and adverse event profile of felodipine in an extended-release (ER) formulation given once daily as monotherapy. Doses of 5 mg, 10 mg or 20 mg felodipine ER were compared with placebo in 183 patients with mild or moderate hypertension. All antihypertensive medication was discontinued on entering a 4-week placebo run-in period. If, at the end of the run-in period, supine diastolic blood pressure was in the range greater than 95 less than 120 mmHg, patients were randomly allocated to double-blind treatment with felodipine, 5 mg, 10 mg or 20 mg, or placebo, to be taken once daily for 4 weeks. Supine and standing blood pressure, heart rate and body weight were measured every 2 weeks during the trial. Assessments were made 24 hours after intake of the study drug. Adverse events were recorded at each review. Over the 4-week treatment period, a dose-related decrease in supine diastolic blood pressure was observed, this reduction occurring already during the first 2 weeks of active treatment. In the placebo group and the felodipine 5 mg, 10 mg and 20 mg groups, supine blood pressure (systolic/diastolic) decreased by 7/6 mmHg, 9/8 mmHg, 12/10 mmHg and 14/11 mmHg, respectively. Supine diastolic blood pressure reduction in the felodipine 10 mg group and both systolic and diastolic blood pressure reductions in the 20 mg group were significantly greater than with placebo. Standing diastolic blood pressure reduction was significantly greater in all three dose groups on felodipine compared with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)     

Effects of eprosartan versus enalapril in hypertensive patients on the renin-angiotensin-aldosterone system and safety parameters: results from a 26-week, double-blind, multicentre study. Eprosartan Multinational Study Group

A double-blind comparator study was performed in 528 hypertensive patients [baseline sitting diastolic blood pressure (SitDBP) 95-114 mmHg]. The primary objective was to compare the incidence of drug-related cough in patients treated with enalapril and eprosartan. The secondary objective was to compare antihypertensive efficacy between treatments. This paper reports the effects seen on the safety profile, plasma renin activity, aldosterone and angiotensin II (A-II) in each treatment group. Eprosartan was titrated from 200 mg b.i.d. to 300 mg b.i.d. and enalapril from 5 mg o.d. to 20 mg o.d. over 12 weeks. Hydrochlorothiazide (HCTZ) 12.5-25 mg o.d. could be added where required to the treatment for the final six weeks of the titration phase if SitDBP > or = 90 mmHg. Patients received the maximum titrated dosage during the maintenance phase. In the study overall, similar mean changes in blood pressure from baseline were evident with each treatment. Measurement of mean plasma neurohormone levels showed significant increases in renin activity in both groups and statistically significant A-II elevations in the eprosartan group (p < 0.05). Neither eprosartan nor enalapril significantly altered serum lipid profiles or electrolyte levels. Most adverse experiences reported throughout the study were mild or moderate in both treatment groups. Fewer patients receiving eprosartan (4.9%) than enalapril (9.1%) discontinued treatment because of adverse experiences. In conclusion, the results of this study show that eprosartan is well tolerated. Both eprosartan and enalapril significantly increased plasma renin activity while plasma A-II was elevated in the eprosartan group.     

Effect of dexfenfluramine treatment on body weight,blood pressure and noradrenergic activity in obese hypertensive patients

Summary The effect of dexfenfluramine (dF) on body weight, blood pressure and noradrenergic activity were studied in 30 obese hypertensive patients randomly divided into two groups and treated for 3 months either with dF (30 mg daily; 16 subjects) or placebo (Pl; 14 subjects). 11 patients from the dF group and 9 patients given Pl completed the entire experimental protocol, including monthly visits for metabolic and hormonal measurements, as well as a bicycle exercise test with arterial catheterisation for haemodynamic and catecholamine measurements performed before and after 3 months of treatment.A progressive significant decrease in body weight, averaging 6.0 kg after 3 months was observed in the dF-treated group, whereas loss of weight in the placebo group (1.4 kg) was not significant. While blood pressure and noradrenergic activity, assessed as changes in the plasma levels and urinary excretion of norepinephrine, remained unaffected in the Pl group, a significant drop in the supine systolic and diastolic blood pressures, as well as in the resting venous norepinephrine level and in urinary norepinephrine excretion was found after the first month of dF administration. In addition, the exercise-induced rise in systolic and diastolic blood pressure, as well as in arterial plasma norepinephrine and epinephrine concentrations, was significantly reduced after 3 months of dF administration; there were no such changes in the Pl-treated group.The results of the present study indicate that, in addition to the weight-reducing effect of dexfenfluramine, its hypotensive effect may be mediated by a decrease in noradrenergic activity.     

A new Ca-antagonist, azelnidipine, reduced blood pressure during exercise without augmentation of sympathetic nervous system in essential hypertension: a randomized, double-blind, placebo-controlled trial

This study was carried out to evaluate the effect of a new long-acting calcium-channel antagonist, azelnidipine, on hemodynamic and neural responses to exercise. Ten patients (age, 36-69 years) with mild essential hypertension were enrolled in this study. A randomized, double-blind, crossover treatment of azelnidipine at a dose of 8.0 mg once daily for 4 weeks was performed. After a 4-week placebo period, the patients exercised in a submaximal test by using an ergometer with azelnidipine or placebo treatment. The changes caused by exercise in arterial blood pressure (BP), heart rate, cardiac output (CO), and systemic vascular resistance were evaluated. In addition, the plasma norepinephrine (NE), epinephrine (E), plasma renin activity, and plasma aldosterone concentration were determined at rest, at peak exercise, and at the recovery period. Both the SBP and diastolic (D) BP were decreased at rest by azelnidipine treatment (from 158 +/- 10/97 +/- 7 to 145 +/- 14/90 +/- 9 mm Hg). Azelnidipine significantly decreased both SBP and DBP during exercise (SBP, F = 6.09, p < 0.05, Fi = 0.612, NS; DBP, F = 17.78, p < 0.001, Fi = 0.298, NS). No significant changes in the resting heart rate and CO were observed, and the exercise-induced increase of these parameters was also not affected by azelnidipine. Azelnidipine produced no significant change of the resting plasma NE and E levels and an exercise-induced increase of plasma NE. In conclusion, these results indicate that azelnidipine, different from another dihydropyridine-type calcium channel antagonists, does not produce any changes in the hemodynamic and neurohumoral response to exercise, and it may be beneficial for patients with mild essential hypertension.     

国产厄贝沙坦治疗轻中度高血压的临床疗效观察

目的观察国产厄贝沙坦（irbesartan,吉加）治疗轻、中度原发性高血压的疗效及安全性。方法将60例轻、中度高血压患者随机分为2组,治疗组30例口服国产厄贝沙坦片150mg,每天1次,观察组30例口服进口厄贝沙坦片150mg,每天1次。治疗时间为8周。治疗4周后对舒张压（DBP）≥90mmHg者,药物剂量增至300mg,每天1次。结果经过8周治疗后,治疗组血压由155/97mmHg降至138/86mmHg,对照组血压由155/98mmHg降至136/85mmHg。两组与服药前比较,血压均有明显降低（t值分别为25.94,29.35,P均〈0.01）,总有效率分别为80.00%和83.33%（χ^2=0.004,P〉0.05）。两组在治疗过程中均未发生明显不良反应,也无明显心率变化。结论国产与进口厄贝沙坦对轻、中度原发性高血压具有相近的降压效果和安全性。     

EFFECT OF TEMOCAPRIL ON HAEMODYNAMIC AND HUMORAL RESPONSES TO EXERCISE IN PATIENTS WITH MILD ESSENTIAL HYPERTENSION

1. This study was carried out to evaluate the effect of temocapril on haemodynamic and humoral responses to exercise in nine patients with mild essential hypertension (WHO stages I and II). 2. After a 4-week placebo period, temocapril was administered at a dose of 1.0 mg once daily for 2–4 weeks. Graded submaximal bicycle ergometer exercise was performed before and after temocapril treatment, and the changes in arterial blood pressure, heart rate, cardiac output (CO), and systemic vascular resistance (SVR) were evaluated. In addition, the plasma norepinephrine (NE) level was determined both at rest and peak exercise before and after temocapril treatment. 3. Both the systolic and diastolic blood pressure were reduced at rest and during exercise by temocapril treatment. No significant change in the resting heart rate and CO was observed, and the exercise-induced increase of these parameters was also not affected by temocapril. In contrast, the resting SVR was significantly decreased by temocapril, although the exercise SVR was similar during both temocapril and placebo treatment. 4. Although there was no significant change in the plasma NE level with temocapril treatment, the exercise-induced increase of plasma NE was significantly suppressed by temocapril. 5. These results indicate that temocapril reduces the blood pressure without causing any significant changes in the heart rate and CO at rest, and that it does not produce any changes in the haemodynamic response to exercise.     

A double-blind and cross-over comparison of once daily doxazosin and placebo with steady-state pharmacokinetics in elderly hypertensive patients

Summary The ₁-adrenoceptor antagonist doxazosin has been compared with placebo in 40 elderly hypertensive patients (mean age 71.4 years).At the end of 10 weeks once daily treatment with doxazosin the mean 24-h post-dose changes in standing and supine blood pressure compared with placebo were –6.9/–5.6 mmHg (systolic/diastolic) and –6.2/–5.5 mmHg respectively. The reductions in standing and supine diastolic blood pressures were statistically significant compared with placebo.At the end of treatment steady-state pharmacokinetics were evaluated in 18 patients. The plasma elimination half-life during the dose interval in these patients was 16.1 h (range 10.1–27.1 h) and the median time to peak plasma concentration was 3 h (range 1–4 h).One patient was withdrawn because of adverse effects (headache, weakness, and sweating) during doxazosin treatment.Once daily doxazosin reduced diastolic blood pressure and was well tolerated in these elderly hypertensive patients.     

Double-blind placebo-controlled trial of terazosin effect on blood pressure and urinary output of dopamine in hypertensive patients.

In a parallel, double-blind study, 12 untreated hypertensive patients received terazosin (2-4 mg/day for 4 weeks), and 12 received placebo during the same period. Systolic and diastolic blood pressure decreased significantly in the terazosin group, from 150 +/- 5.0 mmHg systolic and 99.6 +/- 2.0 diastolic before treatment, to 134.0 +/- 7.0 systolic and 85.6 +/- 3.0 mmHg diastolic at week 4 of treatment. No significant blood pressure changes occurred in the placebo group. Blood pressure decrease showed a positive correlation (r = .62 and r = .52 for systolic and diastolic blood pressure, respectively) with the patient's age (P less than .05). Total plasma cholesterol decreased 18% in the terazosin group (P less than .05) and 9% in the placebo group (P greater than .05). Urinary dopamine excretion decreased significantly from 692.8 +/- 180.0 to 330.5 +/- 52.0 micrograms/24 hours in the terazosin group (P less than .05) and showed a nonsignificant increase in the placebo group. Compared with 22 age- and sex-matched healthy volunteers, urinary dopamine excretion in the hypertensive group before treatment was not statistically different (779.3 +/- 83.1 micrograms/24 hours). Dopamine excretion was higher in untreated hypertensive men and in male healthy volunteers compared with women. The decrease of urinary dopamine excretion observed under terazosin treatment could be due to a decrease of kidney dopamine synthesis or release induced by blood pressure reduction, or secondarily to the blockade of kidney alpha 1-receptors, modulating dopamine excretion. No significant changes were observed in urinary excretion of noradrenaline and adrenaline.     

盐酸马尼地平片治疗轻中度原发性高血压的疗效和安全性

目的评价盐酸马尼地平片治疗轻中度原发性高血压的疗效和安全性。方法用随机双盲对照研究,设苯磺酸氨氯地平片为对照药物。随机入选病人共60例但脱落1例完成59例,马尼地平组30例,苯磺酸氨氯地平组29例。2组每天分别服用盐酸马尼地平片10～20 mg和苯磺酸氨氯地平片5～10 mg,两药均为每日1次,共8周。结果治疗8周后,盐酸马尼地平片组收缩压和舒张压分别下降(8.70±13.11)mmHg和(7.90±5.54)mmHg,苯磺酸氨氯地平片组分别下降为(13.28±13.40)mmHg和(11.66±7.66)mmHg,与治疗前相比均有统计学意义(均P<0.05)。2组均无严重不良事件发生。结论盐酸马尼地平片每日服用1次,可显著地、平稳地降低血压,患者耐受性较好。     

Switch from ABCD pretreatment to A-II-A treatment: a multinational, open, centrally randomized, prospective parallel group comparison

The aim of this trial was to evaluate the efficacy and safety of switching antihypertensive monotherapy from a non-angiotensin II receptor blocker treatment, i.e., angiotensin-converting enzyme (ACE) inhibitor, beta-blocker, calcium (Ca2+) channel blocker or diuretic, to monotherapy with candesartan cilexetil 8 or 16 mg once daily. Patients (age 18-74 years) with mild to moderate essential hypertension were enrolled in this multinational, open-label, centrally randomized, prospective parallel group study. Previous antihypertensive treatment, with either an ACE inhibitor, a beta-blocker, a Ca2+ channel blocker or a diuretic, was maintained for a run-in period of 4 weeks and was then substituted at the baseline visit where patients were randomized into two groups to receive either candesartan cilexetil 8 mg (n = 985) or 16 mg (n = 982) once daily for an 8-week treatment period. Blood pressure (BP) reduction was the primary endpoint after 4 weeks of therapy and the secondary endpoint after 8 weeks of therapy. Results of the first 4 weeks of therapy are presented here. A total of 1,967 patients were included: 985 received candesartan cilexetil 8 mg and 982 candesartan cilexetil 16 mg once daily; 1,879 patients were included in the intention-to-treat analysis. The percentages of patients receiving an ACE inhibitor, a beta-blocker, a Ca2+ channel blocker or a diuretic as previous antihypertensive treatment were 44.7, 18.8, 30.6 and 5.9%, respectively. After 4 weeks of treatment with candesartan cilexetil 8 and 16 mg, sitting diastolic and systolic BP were reduced (mean +/- SD): -7 +/- 10 and -14 +/- 17 mmHg, and -8 +/- 10 and -16 +/- 16 mmHg, respectively. The percentage of patients who were still borderline hypertensive or hypertensive after 4 weeks of substitute treatment was lower in the candesartan cilexetil 16 mg group than in the 8 mg group: 7.1 and 5.3%, respectively, versus 9 and 7.4%, respectively. Reported adverse events were mild or moderate in intensity and in accordance with those reported in the literature. Candesartan cilexetil can be considered an effective and safe alternative to other common antihypertensive monotherapies in a large spectrum of patients with mild and moderate hypertension.     

复方非洛地平缓释片治疗轻中度原发性高血压患者的有效性及安全性随机双盲临床试验

目的探讨复方非洛地平缓释片治疗轻中度原发性高血压患者的有效性和安全性。方法抽取158例患者,筛选出100例,将其随机分为对照组和试验组,对治疗结果进行对比。结果主要疗效:在接受8周治疗后,试验组患者舒张压平均变化值为(-9.0±8.2)mmHg,对照组患者舒张压平均变化值为(-9.2±7.6)mmHg;次要疗效:试验组收缩压变化值为(-8.0±9.2)mmHg,对照组收缩压变化值为(-7.7±8.8)mmHg;试验组舒张压变化值为(-5.6±6.3)mmHg,对照组舒张压为(-5.9±5.66)mmHg。结论复方非洛地平缓释片是治疗轻中度原发性高血压效果较好,安全性较高的药物。