[Controlled clinical trial for the comparison of tolerance of two aldosterone antagonists].
ETAHP was a randomized multicentre study in general practice. The objective of the study was to assess the clinical safety of RU 28318, a new aldosterone antagonist, compared with spironolactone. 80 hypertensive patients were recruited by 52 general practitioners and treated with 160 mg of RU 28318 or 80 mg spironolactone (the doses had previously shown to be pharmacologically equivalent) for one year. The main end-point was the occurrence of gynecomastia. During the follow-up period, 18 gynecomastia were observed, 7 in the RU 28318 group and 11 in the spironolactone group, after 4 to 5 months of treatment. This difference is not statistically significant (p = 0.15). There were no statistically significant differences for the other clinical or biological end points. Centralized randomized allocation of treatment and transmission of data were carried out using a telematic system (the French Minitel system). The observed rate of gynecomastia in the RU 28318 group, not statistically different from that in the spironolactone group, was in agreement with the results of others studies conducted at the same time and resulted in the discontinuation of the development of the molecule.
Leizorovicz
A
A
Unité de Pharmacologie Clinique, Lyon.
Guenaneche
F
F
Luciani
J
J
Boissel
J P
JP
D006177:Gynecomastia / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D013148:Spironolactone / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; C041006:RU 28318
Essai contrôle de tolérance comparant deux traitements antagonistes de l'aldostérone. Groupe ETAHP.