TROUGH PEAK RATIO (T/P) OF INDAPAMIDE 1.5 MG SUSTAINED-RELEASE FORM ASSESSED BY AMBULATORY BLOOD-PRESSURE MONITORING (ABPM)/

Because of the high variability of casual blood pressure measurements, ABPM has become a complementary clinical tool for evaluating antihype rtensive treatment. Nevertheless, there is still a lack of practical g uidelines to interpret the data. A review of the literature shows that ABPM efficacy data are analyzed differently, especially the trough-to -peak ratio proposed by the Food and Drug Administration. Published tr ough-to-peak ratios are widely disparate due to the diversity of the c alculation methods which are most often not justified. Thus inappropri ate comparisons of these results can easily produce incorrect conclusi ons. The aim of this review is to select, through the literature, basi c methodological requirements commonly agreed on for accurate assessme nt of trough-to-peak ratio, and to apply them to the ABPM data on inda pamide, a diuretic related to the thiazides. Six methodological requir ements commonly agreed on at this time are the following: 1. study des ign : placebo-controlled study with a placebo run-in period; 2. patien ts selection : compliance with the study protocol, record obtained bef ore and after treatment for each patient; 3. population analysis: whol e and responder population; 4. quality control of the records; 5. plac ebo effect subtraction: 6. global and individual calculation with the indication of median values. Given that, no T/P ratio, especially for a diuretic, has yet been calculated according to these requirements, t he above methodological points were taken into account for the T/P cal culation of indapamide, from a placebo-controlled dose-finding study i nvolving 285 patients.