Mallion J M, Asmar R, Boutelant S, Guez D
Service de Médecine Interne et Cardiologie, CHU Grenoble, France.
J Cardiovasc Pharmacol. 1998 Oct;32(4):673-8. doi: 10.1097/00005344-199810000-00023.
The antihypertensive efficacy of a 1.5-mg sustained-release formulation (SR 1.5) of indapamide, a diuretic related to thiazide, has been pointed out by using conventional sphygmomanometric measurement 24 h after dosing in clinic, in two large European randomized, double-blind, controlled studies (2 and 3 months). One of these studies was then extended to 12 months, as a complementary open study. Quality-controlled ambulatory blood pressure monitoring (ABPM) data for a total of 216 patients from these studies are presented, including subgroups of hypertensives and responders. Indapamide SR 1.5 achieves an adequate 24-h blood pressure control by significantly reducing the 24-h, diurnal, and nocturnal blood pressures versus baseline, confirming the sphygmomanometric data. The benefit at 2 and 3 months is maintained at 1 year, which confirms the long-term efficacy of SR 1.5 mg. The trough-to-peak ratio--not previously calculated for a diuretic according to international guidelines--meets Food and Drug Administration requirements and confirms the 24-h efficacy of indapamide SR 1.5.
在两项大型欧洲随机、双盲、对照研究(为期2个月和3个月)中,通过在临床给药24小时后使用传统血压计测量,已指出与噻嗪类相关的利尿剂吲达帕胺1.5毫克缓释制剂(SR 1.5)的降压效果。其中一项研究随后作为补充开放性研究延长至12个月。本文呈现了来自这些研究的总共216例患者的质量控制动态血压监测(ABPM)数据,包括高血压患者亚组和反应者亚组。吲达帕胺SR 1.5通过与基线相比显著降低24小时、日间和夜间血压,实现了充分的24小时血压控制,证实了血压计测量数据。2个月和3个月时的益处持续到1年,这证实了1.5毫克SR的长期疗效。谷峰比(此前未按照国际指南针对利尿剂进行计算)符合美国食品药品监督管理局的要求,并证实了吲达帕胺SR 1.5的24小时疗效。