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吲达帕胺缓释片1.5mg在高血压管理方案中的临床定位

Clinical positioning of indapamide sustained release 1.5mg in management protocols for hypertension.

作者信息

Leonetti G

机构信息

Medical University of Milano and Cardiovascular Rehabilitation and Cardiac Disease Unit, S. Luca Hospital IRCCS, Italy.

出版信息

Drugs. 2000;59 Suppl 2:27-38; discussion 39-40. doi: 10.2165/00003495-200059002-00004.

Abstract

Indapamide sustained release (SR) 1.5mg is a new galenic formulation that is characterised by a relatively constant plasma concentration at steady state, with only minor fluctuations during the 24-hour period. A dose-titration study of 3 doses of indapamide SR (1.5, 2 and 2.5mg) given once daily has shown that the 3 dosages are equipotent in lowering blood pressure, and have an effect similar to that of indapamide immediate-release (IR) 2.5mg; all were statistically more effective than placebo. The percentage of hypertensive patients whose serum potassium was less than 3.4 mmol/L was significantly lower after indapamide SR 1.5mg than after indapamide IR 2.5mg. Neither indapamide formulation had any significant effects on lipid profile, glucose, urea and serum creatinine; only uric acid was slightly raised during the 2-month study. In an equivalence study, indapamide SR 1.5mg and IR 2.5mg produced similar blood pressure reductions (within the equivalence limit of +/-5mm Hg), whereas the percentage of patients whose serum potassium fell to less than 3.4 mmol/L was lower in the IR 1.5mg group than in the SR 2.5mg group. Antihypertensive treatment with indapamide SR 1.5mg once daily produced reductions in blood pressure in elderly patients with systolic/diastolic or isolated systolic hypertension that were similar to reductions with amlodipine 5 mg/day. The incidence of adverse effects was very low in all studies with indapamide SR 1.5mg and very similar to that in the placebo group, confirming thereby the improvement in the efficacy: tolerance ratio with the new indapamide compound.

摘要

吲达帕胺缓释片(SR)1.5毫克是一种新的剂型,其特点是稳态时血浆浓度相对恒定,24小时内仅有轻微波动。一项关于每日一次给予3种剂量(1.5、2和2.5毫克)吲达帕胺缓释片的剂量滴定研究表明,这3种剂量在降低血压方面等效,且效果与2.5毫克吲达帕胺速释片(IR)相似;所有剂量在统计学上均比安慰剂更有效。服用1.5毫克吲达帕胺缓释片后血清钾低于3.4毫摩尔/升的高血压患者百分比显著低于服用2.5毫克吲达帕胺速释片后。两种吲达帕胺制剂对血脂、血糖、尿素和血清肌酐均无显著影响;在为期2个月的研究中,仅尿酸略有升高。在一项等效性研究中,1.5毫克吲达帕胺缓释片和2.5毫克吲达帕胺速释片降低血压的效果相似(在等效限值±5毫米汞柱范围内),而血清钾降至低于3.4毫摩尔/升的患者百分比在1.5毫克吲达帕胺速释片组低于2.5毫克吲达帕胺缓释片组。每日一次服用1.5毫克吲达帕胺缓释片进行降压治疗,在收缩期/舒张期或单纯收缩期高血压老年患者中降低血压的效果与每日服用5毫克氨氯地平相似。在所有使用1.5毫克吲达帕胺缓释片的研究中,不良反应发生率极低,且与安慰剂组非常相似,从而证实了这种新型吲达帕胺化合物的疗效:耐受性比有所改善。

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