Antianginal and anti-ischemic efficacy of immediate-release nisoldipine in chronic stable angina pectoris.
A double-blind, randomized, placebo-controlled, crossover study tested peak and trough efficacy of immediate-release nisoldipine (20 mg twice daily) added to existent beta-adrenergic blocking therapy. Patients were randomized with a history of chronic stable angina, while receiving a stable regimen of a beta-blocking agent, with exercise test-induced angina in association with 1 mm horizontal or downsloping ST-segment depression and exercise test reproducibility of +/- 15%. Ambulatory electrocardiographic monitoring (48-hour) was performed at 3 of 5 centers (44 patients). Efficacy was achieved in 53 patients (26 taking immediate-release nisoldipine/placebo in sequence and 27 taking placebo/immediate-release nisoldipine in sequence). Total exercise time increased compared with placebo at peak, but only a trend was seen at trough. Time to 1 mm ST-segment depression at peak and trough and ambulatory electrocardiographic parameters were also improved. Adverse effects were mild. This trial confirms that immediate-release nisoldipine when added to existent beta-blocker therapy is an active antianginal and anti-ischemic agent, but that the immediate-release formulation loses its antianginal effect at the end of its dosing interval (9 to 14 hours). This drug is therefore being examined in a new extended-release formulation (Coat-Core).
Glasser
S P
SP
Division of Clinical Pharmacology, University of South Florida College of Medicine, Tampa 33613.
Bittar
N
N
Labreche
D G
DG
Singh
B
B
Katz
R
R
Schulman
P
P
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000328:Adult; D000787:Angina Pectoris / Q000517:prevention & control*; D001794:Blood Pressure / Q000187:drug effects; D002908:Chronic Disease; D004311:Double-Blind Method; D015716:Electrocardiography, Ambulatory / Q000187:drug effects; D005080:Exercise Test; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D017202:Myocardial Ischemia / Q000517:prevention & control*; D015737:Nisoldipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos
D000319:Adrenergic beta-Antagonists; D010919:Placebos; D015737:Nisoldipine