| Antianginal efficacy and safety of ivabradine compared with amlodipine in patients with stable effort angina pectoris: a 3-month randomised, double-blind, multicentre, noninferiority trial. | |
| | |
MedLine Citation:
|
PMID: 17335297 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND AND OBJECTIVE: Current medical therapies for the symptoms of angina pectoris aim to improve oxygen supply and reduce oxygen demand in the myocardium. Not all patients respond to current antianginal monotherapy, or even combination therapy, and a new class of antianginal drug that complements existing therapies would be useful. This study was undertaken to compare the antianginal and anti-ischaemic effects of the novel heart-rate-lowering agent ivabradine and of the calcium channel antagonist amlodipine. PATIENTS AND METHODS: Patients with a >/=3-month history of chronic, stable effort-induced angina were randomised to receive ivabradine 7.5mg (n = 400) or 10mg (n = 391) twice daily or amlodipine 10mg once daily (n = 404) for a 3-month, double-blind period. Bicycle exercise tolerance tests were performed at baseline and monthly intervals. The primary efficacy criterion was the change from baseline in total exercise duration after 3 months of treatment. Secondary efficacy criteria included changes in time to angina onset and time to 1mm ST-segment depression, rate-pressure product at trough drug activity, as well as short-acting nitrate use and anginal attack frequency (as recorded in patient diaries). RESULTS: At 3 months, total exercise duration was improved by 27.6 +/- 91.7, 21.7 +/- 94.5 and 31.2 +/- 92.0 seconds with ivabradine 7.5 and 10mg and amlodipine, respectively, both ivabradine groups were comparable to amlodipine (p-value for noninferiority < 0.001). Similar results were observed for time to angina onset and time to 1mm ST-segment depression. Heart rate decreased significantly by 11-13 beats/min at rest and by 12-15 beats/min at peak of exercise with ivabradine but not amlodipine, and rate-pressure product decreased more with ivabradine than amlodipine (p-value vs amlodipine <0.001, at rest and at peak of exercise). Anginal attack frequency and short-acting nitrate use decreased substantially in all treatment groups with no significant difference between treatment groups. The most frequent adverse events were visual symptoms and sinus bradycardia with ivabradine (0.8% and 0.4% withdrawals, respectively) and peripheral oedema with amlodipine (1.5% withdrawals). CONCLUSIONS: In patients with stable angina, ivabradine has comparable efficacy to amlodipine in improving exercise tolerance, a superior effect on the reduction of rate-pressure product (a surrogate marker of myocardial oxygen consumption) and similar safety. |
| | |
Authors:
|
Witold Ruzyllo; Michal Tendera; Ian Ford; Kim M Fox |
Related Documents
:
|
3907677 - Comparison of oxyfedrine and atenolol in angina pectoris--a double-blind study. 6430057 - Transdermal isosorbide dinitrate in angina pectoris: effect of acute and sustained ther... 1334947 - Spontaneous superoxide generation by polymorphonuclear leukocytes isolated from patient... 19730357 - High-intensity aerobic interval training in a patient with stable angina pectoris. 15155427 - Strong correlation of maximal squat strength with sprint performance and vertical jump ... 3774237 - Elevation of dental pain threshold induced in man by physical exercise is not reversed ... |
Publication Detail:
|
Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
|
Title: Drugs Volume: 67 ISSN: 0012-6667 ISO Abbreviation: Drugs Publication Date: 2007 |
Date Detail:
|
Created Date: 2007-03-05 Completed Date: 2007-05-15 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 7600076 Medline TA: Drugs Country: New Zealand |
Other Details:
|
Languages: eng Pagination: 393-405 Citation Subset: IM |
Affiliation:
|
Department of Coronary Artery Disease and Cardiac Catheterization Laboratory, Institute of Cardiology, Warsaw, Poland. wruzyllo@ikard.pl |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Aged Amlodipine / adverse effects, therapeutic use* Angina Pectoris / drug therapy* Benzazepines / administration & dosage, adverse effects, therapeutic use* Blood Pressure / drug effects Calcium Channel Blockers / adverse effects, therapeutic use* Cardiotonic Agents / administration & dosage, adverse effects, therapeutic use* Double-Blind Method Electrocardiography Exercise Tolerance / drug effects Female Heart Rate / drug effects Humans Male Middle Aged Myocardial Ischemia / drug therapy Nitrates |
| Chemical | |
Reg. No./Substance:
|
0/Benzazepines; 0/Calcium Channel Blockers; 0/Cardiotonic Agents; 0/Nitrates; 155974-00-8/ivabradine; 88150-42-9/Amlodipine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Use of sirolimus in solid organ transplantation.
Next Document: Insulin lispro: a review of its use in the management of diabetes mellitus.