[Efficacy and duration of effect of two delayed-action preparations of gallopamil in patients with exercise angina].
In 15 subjects (13 male, 2 female) with reproducible threshold ischaemic effort angina, the efficacy and the duration of the effect of two different formulations of gallopamil in equal doses were evaluated. One of these was gallopamil slow release administered twice daily (at 7.00 a.m. and 6.00 p.m.) in doses of 100 mg. The other was action gallopamil immediate release administered four times daily (at 7.00 a.m., 1.00 p.m., 6.00 p.m., 11.00 p.m.) in doses of 50 mg. The double-blind study followed the cross-over model. After one week of run-in with placebo and two-weeks of treatment with active preparations, the patients underwent a clinical examination, an ambulatory electrocardiogram monitoring for 24 hours and two cycloergometric effort tests. The ergometric tests were carried out at 10.00 a.m. and at 5.00 p.m. on the same day so that there was a three-hour interval between the administration of both preparations (slow release and immediate release) and the morning test. The ergometric test which was carried out at 5.00 p.m. was at a ten-hour interval from the administration of slow release and at a four-hour interval from the administration of immediate release. For each period of treatment the gallopamil plasma concentrations were dosed during the ergometric test. In both these tests, the two preparations significantly increased the duration of the exercise compared to the basal values with placebo (7.9 +/- 2.3 minutes with placebo, 9.2 +/- 2.0 minutes with slow release.(ABSTRACT TRUNCATED AT 250 WORDS)
Pucci
P
P
Divisione di Cardiologia, Ospedale di Careggi, Firenze.
Fantoccoli
D
D
Dovellini
E V
EV
Leoncini
M
M
Sarro
F
F
Fazzini
P F
PF
D000787:Angina Pectoris / Q000188:drug therapy* / Q000503:physiopathology; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004562:Electrocardiography; D015444:Exercise; D005080:Exercise Test; D005260:Female; D005711:Gallopamil / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged
D003692:Delayed-Action Preparations; D005711:Gallopamil
Efficacia e durata di effetto di due formulazioni di gallopamil, pronta e ritardo, in pazienti con angina da sforzo.