坎地沙坦酯与氯沙坦治疗轻中度高血压病的比较

目的 比较坎地沙坦酯与氯沙坦治疗轻中度高血压病患者的降压疗效.方法 采用随机、双盲研究方法.经2周的单盲、安慰剂导入期,72例坐位舒张压在95～115 mm Hg之间的高血压患者被随机分入坎地沙坦酯4mg/d(n=36)或氯沙坦50mg/d(n=36).4周末.如坐位舒张压仍≥95 mm Hg,每日剂量加倍(坎地沙坦酯8mg/d或氯沙坦100mg/d),总疗程8周.结果 两组患者服药后血压均显著降低(P＜0.01).经8周治疗,坎地沙坦酯组平均坐位收缩压与舒张压分别降低15.0%与13.7%,在氯沙坦组分别为13.7%与14.0%.两药的有效率无显著性差异(坎地沙坦酯组75.0%,氯沙坦组71.4%,P＞0.05).与坎地沙坦酯组不同,氯沙坦组血尿酸水平显著降低.结论 在轻中度高血压的治疗中,坎地沙坦与氯沙坦同样有效和安全.     

与氯少坦对照评价坎地沙坦西酯治疗轻 中度高血压的疗效和安全性

目的评价坎地沙坦西酯对轻、中度原发性高血压的降压疗效及安全性。方法采用随机双盲研究方法,坎地沙坦西酯和氯沙坦随机、双盲治疗轻、中度原发性高血压患者40例,男性30例,女性10例,年龄(46±6)岁,各组20例,给予双盲药坎地沙坦西酯8mg口服,每日1次,或氯沙坦50mg口服,每日1次;4周后根据血压情况决定维持原剂量或分别增加到12mg口服,每日1次,或100mg口服,每日1次;总疗程8周。结果坎地沙坦西酯治疗原发性轻、中度高血压8周末的显效率55%,总有效率75%,收缩压下降(20.0±12.5)mmHg,下降幅度为15.2%;舒张压下降(10.0±2.4)mmHg,下降幅度为10.8%,出现不良反应的发生率为5%。结论坎地沙坦西酯治疗轻、中度原发性高血压的短期疗效明显,每日1次,疗效持久稳定,不良反应少。     

国产坎地沙坦酯与依那普利治疗原发性轻中度高血压疗效比较

目的:探讨国产坎地沙坦酯对原发性轻中度高血压患者的疗效和安全性。方法:将60例原发性轻中度高血压患者随机分为坎地沙坦酯组和依那普利组,采用双盲双模拟平行对照研究。经过2周的安慰剂清洗期后两组患者分别接受坎地沙坦酯8 mg/d或依那普利10 mg/d。4周后若达到预期降压效果,则继续原剂量服药至8周。如降压效果不理想,加用氢氯噻嗪片(每次12.5 mg,每日1次),继续服药4周。观察所有入选患者8周内的血压、不良反应和生化指标变化。结果:治疗结束时坎地沙坦酯组收缩压下降20.2 mm Hg(1 mm Hg=0.133 kPa),舒张压下降13.9mm Hg;依那普利组收缩压下降19.6 mm Hg,舒张压下降13.8 mm Hg。两组相比差异无统计学意义。两组均未见严重不良反应。结论:国产坎地沙坦酯治疗原发性轻中度高血压安全、有效。     

奥美沙坦酯片治疗轻、中度原发性高血压的疗效和安全性

目的观察奥美沙坦酯片治疗轻、中度原发性高血压的疗效和安全性。方法61例轻、中度原发性高血压患者随机分为奥美沙坦酯组(n=30)和氯沙坦组(n=31),治疗8wk,观察2组治疗前后的血压、心率、心电图和血、尿实验室检查的变化。结果奥美沙坦酯组与氯沙坦组比较,坐位收缩压和舒张压降低程度都有显著差异,分别为(132±13 vs 139±13)mmHg(P<0.01)和(85±9 vs 87±9)mmHg(P<0.05)。奥美沙坦酯组降压有效率为83%;每日1次服用奥美沙坦酯作用可持续24h,药物降低收缩压和舒张压的谷峰比值均>50%。2组药物不良反应发生分别为1例和3例,2组比较无显著差别。结论奥美沙坦酯治疗轻、中度原发性高血压患者,能24h平稳降压,谷峰比满意,且耐受性较好。     

国产坎地沙坦酯与依那普利治疗原发性轻中度高血压疗效比较

目的：探讨国产坎地沙坦酯对原发性轻中度高血压患者的疗效和安全性。方法：将60例原发性轻中度高血压患者随机分为坎地沙坦酯组和依那普利组,采用双盲双模拟平行对照研究。经过2周的安慰剂清洗期后两组患者分别接受坎地沙坦酯8mg／d或依那普利10mg／d。4周后若达到预期降压效果,则继续原剂量服药至8周。如降压效果不理想,加用氢氯噻嗪片（每次12．5mg,每日1次）,继续服药4周。观察所有入选患者8周内的血压、不良反应和生化指标变化。结果：治疗结束时坎地沙坦酯组收缩压下降20．2mmHg（1mmHg=0．133kPa）,舒张压下降13．9mmHg;依那普利组收缩压下降19．6mmHg,舒张压下降13．8mmHg。两组相比差异无统计学意义。两组均未见严重不良反应。结论：国产坎地沙坦酯治疗原发性轻中度高血压安全、有效。     

国产坎地沙坦酯治疗原发性高血压的疗效和安全性评价

目的:评价国产坎地沙坦酯治疗原发性高血压的疗效和安全性。方法:选择轻、中度高血压患者62例,随机分为坎地沙坦酯治疗组(n=32例)和缬沙坦对照组(n=30例),每日1次口服坎地沙坦酯4mg~8mg或缬沙坦80mg,2周后如舒张压≥90mmHg,则剂量加倍,进行8周的临床观察。两组患者年龄、性别、体重、临床指征等基本情况差异无显著性(P>0.05)。结果:两组患者血压均得到明显降低(P<0.01),坎地沙坦酯组显效率56.2%,总有效率88.7%;缬沙坦组显效率65.3%,总有效率86.4%。两组比较差异无显著性(P>0.05)。结论:国产坎地沙坦酯治疗原发性高血压疗效显著,与进口同类药缬沙坦相当,不良反应少,安全有效。     

坎地沙坦和培哚普利治疗原发性高血压的疗效比较

目的:探讨坎地沙坦治疗轻、中度原发性高血压的疗效及安全性.方法:将80例临床确诊为轻、中度原发性高血压患者随机分为治疗组(坎地沙坦组)38例,每日早晨服坎地沙坦8mg;对照组(培哚普利组)42例,每日早晨服培哚普利4mg.两组疗程均为8周.治疗前后观察血压变化、血钾、肝功能、肾功能.结果:服药第8周两观察组血压均较治疗前显著降低(P<0.001),且坎地沙坦的降压作用较培哚普利明显(P<0.001).到第8周末坎地沙坦组与培哚普利组降压总有效率分别为94.3%与89.7%.与观察开始前比较,第8周末血钾,肝功能、肾功能无明显改变.结论:坎地沙坦对轻,中度原发性高血压患者有良好降压效果,服用安全.     

坎地沙坦治疗原发性高血压疗效及安全性分析

目的 观察血管紧张素Ⅱ受体拮抗剂坎地沙坦治疗轻、中度原发性高血压患者的疗效和安全性.方法 82例原发性高血压患者随机分成两组,分别予以坎地沙坦(8 mg·d-1),贝那普利(10 mg·d-1),8周后观察降压效果和降压谷峰比值(T/P).结果 坎地沙坦组和贝那普利组的血压均明显下降P＜0.05,总有效率分别为64%和62%,无显著性差异(P＞0.05).降压谷峰比值:坎地沙坦组SBP/DBP为0.85/0.83;贝那普利组SBP/DBP为0.68/0.64,前者显著高于后者(P＜0.05).结论 坎地沙坦(8 mg·d-1),对轻、中度原发性高血压降压疗效确切,谷峰比值高.     

坎地沙坦酯治疗轻中度原发性高血压疗效观察

目的评价坎地沙坦酯治疗轻中度原发性高血压的疗效、安全性。方法采用随机双盲分组试验,120例轻中度原发性高血压患者随机分为：坎地沙坦酯组（60例）和缬沙坦组（60例）,分别每天一次口服坎地沙坦酯8mg或缬沙坦80mg。药物治疗前、后行24h动态血压监测。结果①8周末,两组坐位收缩压（SBP）谷值及坐位舒张压（DBP）谷值均较基线明显下降,坎地沙坦酯组的SBP谷值及DBP谷值下降幅度大于缬沙坦组;②坎地沙坦酯降低轻中度高血压的有效率高于缬沙坦。结论①坎地沙坦酯8mg每天一次口服治疗轻中度原发性高血压安全、有效;②坎地沙坦酯8mg每天一次口服降压作用可维持24h。     

国产坎地沙坦酯与厄贝沙坦治疗原发性轻中度高血压疗效比较

目的探讨国产坎地沙坦酯对原发性轻中度高血压患者的疗效和安全性。方法60例原发性轻中度高血压患者,随机分为坎地沙坦酯和厄贝沙坦组,每组30例,采用双盲双模拟平行对照研究。经过2周的安慰剂清洗期后两组患者分别接受坎地沙坦酯片一日8mg或厄贝沙坦片一日150mg。2周后如果达到预期降压效果,则继续原剂量服药至4周末。如降压效果不理想,加量(坎地沙坦酯一日12mg或厄贝沙坦一日225mg)继续服药2周。观察所有入选患者4周内的血压、不良反应和生化指标变化。结果治疗结束时坎地沙坦酯组收缩压下降15.1%,舒张压下降12.2%;厄贝沙坦组收缩压下降12.6%,舒张压下降9.2%。两组相比无显著差异。两组均未见严重不良反应。结论国产坎地沙坦酯为治疗原发性轻中度高血压安全且有效的药物。     

坎地沙坦酯治疗轻中度高血压病人的疗效及安全性

目的：评价坎地沙坦酯治疗轻中度高血压病人的疗效及安全性。方法：人选48例轻中度高血压病人，经2周导人期后随机分人试验组和对照组各24例，按双盲、平行临床药理试验方法分别给予坎地沙坦酯8mg和氯沙坦50mg治疗。治疗4周后如不能有效控制血压，则将用药剂量加倍并维持到第8周末。检测病人治疗前、后不同时间的血压，心率，以及血、尿常规，肝、肾功能，并记录服药期间可能发生的不良事件。结果：试验组和对照组降压显效率均为100％，治疗后2周末收缩压(SBP)和舒张压(DBP)均已明显降低。此后血压继续下降，与治疗前相比，用药8周末试验组和对照组SBP分别下降20．3和16．4mmHg，DBP分别下降16．8和16．1mmHg。试验组中有1例病人服药期间出现头痛，1例病人感轻微胸闷和腹胀。两组病人血、尿常规，肝、肾功能均正常。结论：坎地沙坦酯治疗轻中度高血压病人降压效果良好，服用安全。     

Evaluation of the effect of candesartan cilexetil on the steady-state pharmacokinetics of tacrolimus in renal transplant patients

BACKGROUND: Candesartan cilexetil is a possible treatment for hypertension in renal allograft recipients. Tacrolimus is widely used as an immunosuppressant following renal transplantation. The aim of this study was to evaluate the effect of multiple doses of candesartan cilexetil on the steady-state pharmacokinetics of tacrolimus. METHODS: Twelve patients received oral doses of tacrolimus twice daily for 12 days from study day -2 until day 10, single oral doses of candesartan cilexetil placebo on study days -2 to -1, single oral doses of 2 mg candesartan cilexetil once daily on study days 1 to 3, oral doses of 4 mg candesartan cilexetil once daily on study days 4 to 6, and oral doses of 16 mg candesartan cilexetil once daily on study days 7 to 9. Serial blood samples were collected on days -1, 6 and 9 and were analysed for tacrolimus using microparticle enzyme immunoassay. RESULTS: Mean C(max,ss) and AUC(tau,ss) values for tacrolimus on day 6 (4 mg candesartan) and day 9 (16 mg candesartan cilexetil) were similar to those on day -1 (tacrolimus alone). Renal function did not change under treatment with candesartan cilexetil compared with baseline. The co-administration of multiple oral doses of cardesartan cilexetil with oral doses of tacrolimus was well tolerated. CONCLUSIONS: Concomitant administration of multiple doses of candesartan cilexetil does not alter the steady-state pharmacokinetics of tacrolimus.     

Candesartan cilexetil plus hydrochlorothiazide combination: a review of its use in hypertension

The combination of candesartan cilexetil [an angiotensin II type 1 (AT(1)) receptor antagonist] plus hydrochlorothiazide (a thiazide diuretic), has been used in the treatment of patients with hypertension. The blood pressure (BP) lowering effect of various doses of this combination, administered orally once a day for 4 to 52 weeks, has been demonstrated in clinical trials. These studies showed that combinations of candesartan cilexetil 4 to 16 mg with hydrochlorothiazide 12.5 or 25 mg induced significant reductions reductions in systolic (S) BP and diastolic (D) BP from baseline in patients with mild to severe hypertension. Data from clinical trials indicated that reductions in BP induced by candesartan cilexetil 4 to 32 mg/hydrochlorothiazide 12.5 mg combinations were significantly greater than those observed after monotherapy with either drug. Treatment for 8 weeks with candesartan cilexetil 16 mg/hydrochlorothiazide 12.5 mg or candesartan cilexetil 16 mg induced SBP/DBP reductions of 12.0/7.5 mm Hg and 7.5/5.5mm Hg, respectively (p < 0.05 both comparisons). Moreover, data from a randomised, double-blind, placebo-controlled, dose-finding study in 1038 patients with mild to moderate hypertension showed that the greatest reductions in SBP/DBP were achieved by candesartan cilexetil 16 mg/hydrochlorothiazide 12.5 mg. Significant differences in BP reduction in favour of the combination were observed when hypertensive patients were given candesartan cilexetil 4 or 8 mg/hydrochlorothiazide 12.5 mg or hydrochlorothiazide monotherapy for 8 weeks. Additionally, greater efficacy of the combination compared to monotherapy with either drug was demonstrated by response rates to treatment. Moreover, a fixed combination of candesartan cilexetil 16 mg/hydrochlorothiazide 12.5 mg demonstrated a greater antihypertensive effect than losartan 50 mg/hydrochlorothiazide 12.5 mg in two clinical trials. Candesartan cilexetil 8 mg/hydrochlorothiazide 12.5 mg showed a similar antihypertensive effect compared with that of combined lisinopril 10 mg/hydrochlorothiazide 12.5 mg. Candesartan cilexetil/hydrochlorothiazide combination was well tolerated in patients with hypertension. Combined data from placebo-controlled trials showed that most adverse events were uncommon and not serious. Patients receiving combination therapy exhibited, among other adverse events, headache (3.2 vs 5.5% for candesartan cilexetil/hydrochlorothiazide and placebo, respectively), back pain (3.0 vs 2.4%), dizziness (2.6 vs 1.2%) and respiratory infection (2.5 vs 1.4%). Moreover, 3.3 and 2.7% of patients receiving candesartan cilexetil/hydrochlorothiazide or placebo, respectively, discontinued treatment because of adverse events. CONCLUSION: The combination of candesartan cilexetil and hydrochlorothiazide (AT(1)-receptor antagonist and thiazide diuretic, respectively) is an effective treatment for patients with hypertension. Data from randomised, double-blind, placebo-controlled clinical trials showed that this combination is significantly more efficacious than either agent alone. Moreover, the combination of these two agents showed an excellent adverse event profile. Current data support the use of this combination as an alternative when monotherapy with either agent is not effective, and there are no compelling or specific indications for other drugs. However, data from large clinical trials, evaluating morbidity and mortality outcomes, are needed to determine the precise role of candesartan cilexetil/hydrochlorothiazide combination in the treatment of patients with hypertension.     

坎地沙坦酯治疗轻、中度原发性高血压的临床研究

目的 观察坎地沙坦酯片治疗轻、中度原发性高血压的疗效.方法 采用随机、单盲、平行对照试验.将110例原发性高血压患者随机分为治疗组和对照组各55例.治疗组给予坎地沙坦酯片8mg口服治疗,1次/d;对照组给予缬沙坦片80mg口服治疗,1次/d.服用2周后,若舒张压≥12kPa则剂量加倍,疗程为8周.比较2组的降压疗效、幅度及心率变化.结果 治疗组总有效率为90.9%,对照组的87.3%,2组比较无显著差异（P〉0.05）.2组治疗前、后血压降低幅度均有显著差异（P〈0.01）,但2组间比较无显著差异（P〉0.05）.2组治疗前、后心率均无明显变化,组间比较无显著差异（P〉0.05）.结论 坎地沙坦酯片治疗轻、中度原发性高血压疗效确切,不良反应少,患者耐受性良好,临床应用安全,值得临床推广应用     

Antihypertensive treatment in elderly patients aged 75 years or over: a 24-week study of the tolerability of candesartan cilexetil in relation to hydrochlorothiazide

OBJECTIVE: To assess the safety and tolerability of the AT1-receptor blocker candesartan cilexetil in relation to the diuretic hydrochlorothiazide (HCTZ) in elderly patients. DESIGN AND SETTING: A multicentre, double-blind, randomised, parallel group study. 32 general practice centres and 3 hospital centres in Denmark and Finland participated in this study. Patients: 185 patients aged > or =75 years with mean sitting diastolic blood pressure (DBP) of 95 to 114mm Hg. INTERVENTIONS: After a placebo run-in period of 4 to 8 weeks, patients were randomised to once daily treatment with candesartan cilexetil 8mg or HCTZ 12.5mg for 24 weeks. In both treatment groups the dosage could be doubled after > or =2 weeks [according to blood pressure (BP) response] and, if necessary, subsequently decreased if the higher dosage was poorly tolerated. MAIN OUTCOME MEASURES: Proportion of patients with at least 1 adverse event; changes in laboratory values, electrocardiogram and BP during the double-blind treatment period. RESULTS: Once daily candesartan cilexetil 8 to 16mg was very well tolerated. The most common adverse events in both treatment groups were dizziness or vertigo and headache. Although the profile of adverse events was generally similar in the 2 treatment groups, it was notable that hypokalaemia and hyperuricaemia were not found in patients treated with candesartan cilexetil but occurred in 8.1 and 6.5%, respectively, of patients treated with HCTZ. At week 24, the adjusted mean changes in sitting DBP (24 hours postdose) from baseline were -12.0mm Hg [95% confidence interval (CI) -1 0.4 to -13.6] in patients treated with candesartan cilexetil and -11.4mm Hg (95% CI -9.3 to -13.6) in patients treated with HCTZ. The difference between treatments in favour of candesartan cilexetil was not statistically significant. CONCLUSIONS: This study shows that antihypertensive treatment with candesartan cilexetil in elderly patients (aged > or =75 years) is well tolerated with a good safety profile and avoids the metabolic adverse effects of diuretic therapy.     

Pharmacokinetics and haemodynamics of candesartan cilexetil in hypertensive patients on regular haemodialysis

AIMS: The pharmacokinetic profile of candesartan cilexetil might be altered in patients with end-stage renal disease (ESRD). No data are available about the pharmacokinetics and haemodynamics of the angiotensin II receptor antagonist candesartan cilexetil in ESRD patients on regular haemodialysis (HD). METHODS: We performed a repeated dose study (8 mg candesartan cilexetil once daily) in eight male HD patients over a treatment period of 5 days with an additional observation period of 3 days. RESULTS: Pharmacokinetic analysis with nonlinear mixed effects modeling (NONMEM) over the whole treatment period revealed a dependency of the volume of distribution on body weight and of the metabolic clearance on age and body weight in the studied population. No significant drug elimination by HD was observed. The estimated metabolic and intercompartmental clearances were 83 ml min-1 (CV 39%) and 9.9 ml min-1, respectively. The unexplained random variability of the final two compartment model was 30%. In one patient with adult polycystic kidney disease oral clearance decreased during the observation period, attributable to a significant increase in bioavailability. Maximum observed changes in blood pressure were -50/-27+/-14/8 mmHg on day 5 with haemodialysis therapy as compared with changes in blood pressure of -14/-12+/-14/8 mmHg on day 1 without haemodialysis treatment. The observed maximum decrease in systolic blood pressure correlated with the amount of ultrafiltration during the HD session on day 5 (r=0.70, P<0.05). In two patients, one of whom was binephrectomized, severe hypotensive episodes were observed during this HD session. CONCLUSIONS: HD does not influence the elimination kinetics of candesartan. The observed inter- and intraindividual variability of oral clearance and the pronounced influence of HD-induced volume contraction on the haemodynamic effects of candesartan makes it mandatory to carefully monitor HD patients treated with candesartan cilexetil.     

厄贝沙坦治疗原发性高血压病人的疗效和安全性

目的 :评价国产厄贝沙坦对轻、中度原发性高血压病人的降压疗效和安全性。方法 :多中心、随机、双盲、双模拟设计。轻、中度原发性高血压病人 2 16例 ,经 2wk安慰剂导入期后 ,分成 2组 ,分别服厄贝沙坦 15 0mg加氯沙坦模拟药片 1片或氯沙坦 5 0mg加厄贝沙坦模拟药片 2片 ,qd。 4wk后如血压≥ 18.7/12kPa则将剂量加倍 ,共 8wk。另有 2 0例病人开放服厄贝沙坦。结果 :治疗 8wk后 ,厄贝沙坦组和氯沙坦组总有效率为 81.9%和77.0 %。收缩压下降 (2 .9±s 1.9)kPa和 (2 .6±2 .0 )kPa ,舒张压下降 (1.8± 1.1)kPa和 (1.8± 1.2 )kPa ,治疗前后差异均有非常显著意义 (P <0 .0 1) ,组间比较差异无显著意义 (P >0 .0 5 ) ;不良反应 2组分别为 8.7%和 8.9% ,无一例停药 ;开放组 2 4h动态血压监测T/P比值SBP 6 2 % ,DBP 5 6 %。结论 :厄贝沙坦是有效且不良反应少的长效降压药物     

依普罗沙坦与氯沙坦在轻中度原发性高血压病人中的降压疗效比较

目的:以氯沙坦为对照,观察依普罗沙坦治疗轻、中度原发性高血压(EH)病人的疗效与安全性。方法:采用前瞻性、随机、双盲、阳性药对照研究。符合方案的50例轻、中度EH病人经筛选期(2 wk)、安慰剂导入期(2 wk)后,随机分为依普罗沙坦组(n=24)与氯沙坦组(n=26)。在治疗期,2组病人分别每日1次口服依普罗沙坦600 mg或氯沙坦50 mg。若4 wk血压不达标,即坐位舒张压(DBP)≥90 mmHg (1 mmHg=0．133 3 kPa),加氢氯噻嗪12．5 mg,每日1次口服至8 wk。观察治疗前、治疗后4 wk与8 wk血压、心率以及治疗前后血、尿常规,血生化及心电图改变。结果:在治疗后8 wk,依普罗沙坦组的收缩压(SBP)与DBP分别下降了(12±s 10)mmHg与(12±5)mmHg,氯沙坦组的降压幅度分别为(14±9)mmHg与(10±6)mmHg,治疗前后比较有非常显著差异(P<0．01);但2组间血压下降的幅度无显著差异(P>0．05)。依普罗沙坦组与氯沙坦组的降压总有效率分别为100％和8l％,2组疗效无显著差异(P>0．05)。依普罗沙坦组加用氢氯噻嗪病例为9例(38％),而氯沙坦组为6例(23％),p> 0．05。2组心率及血液生化检查结果,治疗前后变化均无显著意义(P>0．05),均无严重不良反应发生。结论:依普罗沙坦与氯沙坦均能有效降低轻、中度EH病人的血压,疗效相似,都具有良好的安全性。