Duration of effects of isradipine during twice daily therapy in angina pectoris
| Autor: | Udho Thadani, Bruce J. Iteld, Stephen L. Archer, Charles Wakeford, Steven G. Chrysant, Jeffrey Gorwit, Steven N. Singh, Thomas D. Giles, David Copen, Stuart Hobbs |
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| Rok vydání: | 1994 |
| Předmět: |
Adult
Male Randomization Chemistry Pharmaceutical Physical exercise Placebo Drug Administration Schedule law.invention Angina Pectoris Angina Placebos Electrocardiography Nitroglycerin Randomized controlled trial Double-Blind Method law Oral administration medicine Humans Pharmacology (medical) Single-Blind Method Adverse effect Aged Pharmacology Isradipine business.industry General Medicine Middle Aged medicine.disease Anesthesia Exercise Test Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Cardiovascular drugs and therapy. 8(2) |
| ISSN: | 0920-3206 |
| Popis: | Isradipine, a 1,4 dihydropyridine calcium channel antagonist, is a potent coronary artery dilator that increases coronary blood flow with little effect on cardiac contractility. Isradipine is an approved antihypertensive agent, but its anti-anginal effects have not been well documented. In this placebo-controlled, double-blind, parallel-group design study we evaluated the duration of effects and safety of isradipine 10 mg bid in male patients with chronic stable angina pectoris. Seventy-two patients experiencing moderately severe angina between 3 and 7.5 minutes during a standard Bruce exercise test received placebo in a single-blind manner for 8–14 days. Sixty-one of these patients had reproducible treadmill exercise test results on three consecutive occasions and underwent further exercise tests at 3, 8, and 12 hours after a placebo period. Patients were then randomized (double blind) to either placebo or isradipine 10 mg bid for 2 weeks. Symptom-limited exercise tests were repeated predose and at 3, 8, and 12 hours after the 0800 hour dose dosing. Exercise duration increased significantly from baseline (last qualifying test during the single-blind placebo therapy, i.e., 0800 hours predose at visit 4) in the isradipine group compared to the placebo group prior to the administration of the 0800 hour dose (i.e., 12 hours after the 2000 hour dose) by 51 vs. 18 seconds, p=0.04; and after the administration of the 0800 hour dose at 3 hours by 78 vs. 29 seconds, p=0.005; and at 8 hours by 54 vs. 18 seconds, p=0.04. Similarly, statistical significance was achieved when exercise data were analyzed using visit 4 (single-blind placebo therapy) corresponding time points as baseline. At 12 hours after the 0800 hour dose, exercise tolerance did not increase significantly after isradipine compared to placebo. Time to 1-mm ST-segment depression increased significantly after isradipine at 3 hours post 0800 hour dose compared to placebo (87 vs. 7 seconds, p |
| Databáze: | OpenAIRE |
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