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坎地沙坦 - 氢氯噻嗪32/12.5毫克和32/25毫克对坎地沙坦单药治疗未达最佳控制效果的患者的降压疗效及耐受性

Antihypertensive efficacy and tolerability of candesartan-hydrochlorothiazide 32/12.5 mg and 32/25 mg in patients not optimally controlled with candesartan monotherapy.

作者信息

Bönner Gerd

机构信息

MEDIAN Kliniken, Bad Krozingen, Germany.

出版信息

Blood Press Suppl. 2008 Dec;2:22-30. doi: 10.1080/08038020802519220.

DOI:10.1080/08038020802519220
PMID:19203019
Abstract

AIM

To evaluate the efficacy and tolerability of candesartan cilexetil 32 mg in combination with hydrochlorothiazide (HCT) 12.5 mg or 25 mg in hypertensive patients not optimally controlled with candesartan monotherapy.

PATIENTS AND METHODS

A total of 3521 patients with treated or untreated hypertension and sitting diastolic blood pressure (DBP) 90-114 mmHg, entered a single-blind run-in phase with candesartan (16 mg for 2 weeks, followed by 32 mg for 6 weeks). At the end of the run-in phase, 1975 patients who still had DBP 90-114 mmHg were randomized to 8 weeks' double-blind treatment with either candesartan 32 mg (n=654), or candesartan-HCT 32/12.5 mg (n=656), or candesartan-HCT 32/ 25 mg (n=665).

PRINCIPAL RESULTS

At randomization, the mean blood pressure was similar in the three treatment groups (approximately 153/97 mmHg). It was reduced during the double-blind treatment phase by 6.1/5.6 mmHg in the candesartan 32 mg group, by 13.0/8.8 mmHg in the candesartan-HCT 32/12.5 mg group, and by 15.5/10.0 mmHg in the candesartan-HCT 32/25 mg group (p<0.01 for all between treatment comparisons). All study treatments were generally well tolerated.

CONCLUSION

Candesartan-HCT 32/12.5 mg and candesartan-HCT 32/25 mg are highly effective and provide improved blood pressure reduction and blood pressure control relative to candesartan 32 mg monotherapy, with maintained tolerability, in hypertensive patients whose blood pressure is not optimally controlled with candesartan monotherapy. Furthermore, candesartan-HCT 32/25 mg is more effective than candesartan-HCT 32/12.5 mg in this population.

摘要

目的

评估坎地沙坦酯32毫克联合12.5毫克或25毫克氢氯噻嗪(HCT)对单用坎地沙坦未能实现最佳控制的高血压患者的疗效和耐受性。

患者与方法

总共3521例已治疗或未治疗的高血压患者,坐位舒张压(DBP)为90 - 114毫米汞柱,进入坎地沙坦单盲导入期(16毫克服用2周,随后32毫克服用6周)。在导入期结束时,1975例DBP仍为90 - 114毫米汞柱的患者被随机分为接受8周双盲治疗,分别为坎地沙坦32毫克(n = 654),或坎地沙坦 - HCT 32/12.5毫克(n = 656),或坎地沙坦 - HCT 32/25毫克(n = 665)。

主要结果

随机分组时,三个治疗组的平均血压相似(约153/97毫米汞柱)。在双盲治疗阶段,坎地沙坦32毫克组血压降低6.1/5.6毫米汞柱,坎地沙坦 - HCT 32/12.5毫克组降低13.0/8.8毫米汞柱,坎地沙坦 - HCT 32/25毫克组降低15.5/10.0毫米汞柱(所有组间比较p<0.01)。所有研究治疗的耐受性总体良好。

结论

对于单用坎地沙坦未能实现最佳控制血压的高血压患者,坎地沙坦 - HCT 32/12.5毫克和坎地沙坦 - HCT 32/25毫克高度有效,相对于坎地沙坦32毫克单药治疗能更好地降低血压并控制血压,且耐受性良好。此外,在该人群中,坎地沙坦 - HCT 32/25毫克比坎地沙坦 - HCT 32/12.5毫克更有效。

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