title: [Evaluation of trough/peak ratio of indapamide 1.5 mg sustained-release form assessed by ambulatory blood pressure monitoring].
abstract: Because of the high variability of casual blood pressure measurements. ABPM has become a complementary clinical tool for evaluating antihypertensive treatment. Nevertheless, there is still a lack of practical guidelines 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 trough-to-peak ratios are widely disparate due to the diversity of the calculation methods which are most often not justified. Thus inappropriate comparisons of these results can easily produce incorrect conclusions. The aim of this review is to select, through the literature, basic methodological requirements commonly agreed on for accurate assessment of trough-to-peak ratio, and to apply them to the ABPM data on indapamide, a diuretic related to the thiazides. Six methodological requirements commonly agreed on at this time are the following: 1. study design: placebo-controlled study with a placebo run-in period; 2. patients selection: compliance with the study protocol, record obtained before and after treatment for each patient; 3. population analysis: whole and responder population: 4. quality control of the records: 5. placebo 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, the above methodological points were taken into account for the T/P calculation of indapamide, from a placebo-controlled dose-finding study involving 285 patients.
authors.affiliation: Service de médecine interne et cardiologie, CHU de Grenoble, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Mallion
authors.forename: R
authors.initials: R
authors.lastname: Asmar
authors.forename: E
authors.initials: E
authors.lastname: Ambrosioni
authors.forename: M
authors.initials: M
authors.lastname: MacMahon
authors.forename: J M
authors.initials: JM
authors.lastname: Coupez
authors.forename: A
authors.initials: A
authors.lastname: de Cordoüe
authors.forename: S
authors.initials: S
authors.lastname: Barrandon
authors.forename: Y
authors.initials: Y
authors.lastname: Brault
authors.forename: D
authors.initials: D
authors.lastname: Guez
authors.forename: M
authors.initials: M
authors.lastname: Safar
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D002940:Circadian Rhythm; D003692:Delayed-Action Preparations; D004232:Diuretics / Q000494:pharmacology* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007190:Indapamide / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010919:Placebos; D015203:Reproducibility of Results; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D004232:Diuretics; D010919:Placebos; D007190:Indapamide
vernacular_title: Evaluation du rapport vallée/pic de l'indapamide 1,5 mg comprimé enrobé a libération prolongée par la mesure ambulatoire de la pression artérielle.