ETUDE MULTCENTRIQUE EN DOUBLE AVEUGLE COMPARANT LA RILMENIDINE 1 MG ET L'HYDROCHLOROTHIAZIDE 25 MG CHEZ 244 PATIENTS

Translated title of the contribution: A multicentre double-blind trial comparing rilmenidine 1 mg and hydrochlorothiazide 25 mg in 244 patients

Research output: Chapter in Book/Report/Conference proceedingConference contribution

Abstract

The efficacy and acceptability of Rilmenidine (RIL) were assessed in a multicentre, controlled, double-blind trial versus hydrochlorothiazide (HCZ) in patients with mild to moderate hypertension. After an initial 4 week washout period on placebo, patients with diastolic BP of between 90 and 110 mmHg were administered in monotherapy either RIL 1 mg or HCZ 25 mg for four weeks (Day 0-Day 28). In the following four weeks (Day 28-Day 56), those with diastolic BP of over 90 mmHg were given, in association, the antihypertensive agent that they had not received initially. The other patients continued the trial with single doses of monotherapy. Two hundred and fourty four patients (48.4 ± 0.6 years) with supine systolic and diastolic BP of 155.86 ± 0.96 mmHg and 101.02 ± 0.28 mmHg respectively were randomly allocated to two comparable treatment groups (RIL, n = 120 and HCZ, n = 124). The systolic and diastolic BP increased significantly between Day 0 and Day 28, as much at Day 14 as at Day 28 in both treatment groups. The antihypertensive effect was comparable: at Day 28 the mean fall in systolic/diastolic BP was 16/10 mmHg in the RIL group and 15/9 mmHg in the HCZ group (NS). The clinical acceptability was equivalent in the two groups: secondary effects were responsible for one patient's withdrawal in each group and their incidence was 5% on average, 10% for the most common. Between Day 28 and Day 56, the association of RIL with the initial treatment of HCZ normalised 19.5% (22/48) patients, whilst the association of HCZ to the initial treatment of RIL normalised 14.5% (16/44) more patients. The clinical acceptability of the groups treated with monotherapy (comparable frequency of secondary effects 5%) and that of the groups receiving bitherapy (comparable frequency of secondary effects: 15%) was the same with both agents. Two patients in the HCZ group and two patients on bitherapy (HCZ added to RIL at Day 28) were withdrawn before the end point of the rial because of side effects. RIL and HCZ were equally effective antihypertensive drugs. There were no cases of orthostatic hypotension. The incidence of secondary effects was acceptable although HCZ induced the biological changes associated with diuretic therapy, hypokalemia, hyperuricemia and hypercholesterolemia, which were not observed with rilmenidine.

Translated title of the contributionA multicentre double-blind trial comparing rilmenidine 1 mg and hydrochlorothiazide 25 mg in 244 patients
Original languageFrench
Title of host publicationArchives des Maladies du Coeur et des Vaisseaux
Pages39-46
Number of pages8
Volume82
EditionSPEC. ISS. 5
Publication statusPublished - 1989

Keywords

  • acceptabilite
  • efficacite
  • hydrochlorothiazide
  • hypertension
  • rilmenidine

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Fiorentini, C., Guillet, C., & Guazzi, M. (1989). ETUDE MULTCENTRIQUE EN DOUBLE AVEUGLE COMPARANT LA RILMENIDINE 1 MG ET L'HYDROCHLOROTHIAZIDE 25 MG CHEZ 244 PATIENTS. In Archives des Maladies du Coeur et des Vaisseaux (SPEC. ISS. 5 ed., Vol. 82, pp. 39-46)