Back to Search
Start Over
Results of a curtailed randomized controlled trial, evaluating the efficacy and safety of azimilide in patients with implantable cardioverter-defibrillators: The SHIELD-2 trial
- Source :
- American Heart Journal. 185:43-51
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
Abstract
- BACKGROUND: Frequent hospital attendances in patients with implantable cardioverter-defibrillators (ICDs) result in significant morbidity and health care costs. Current drugs to reduce ICD shocks and hospital visits have limited efficacy and considerable toxicity. We evaluated the efficacy and safety of azimilide, a novel oral class III antiarrhythmic, for use in ICD patients. METHODS: A total of 240 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled trial to evaluate the effect of oral azimilide 75 mg daily in ICD patients with previously documented ventricular tachycardia or ventricular fibrillation, and a left ventricular ejection fraction ≤40%. The primary outcome metric was the adjudicated time-to-first unplanned cardiovascular (CV) hospitalization, or CV emergency department (ED) visit, or CV death. The trial was prematurely discontinued due to withdrawal of study sponsorship. RESULTS: Azimilide demonstrated numerical but statistically nonsignificant reductions in the primary composite outcome (odds ratio [OR] 0.79, 95% CI 0.44-1.44), unplanned CV hospitalizations (OR 0.75, 95% CI 0.41-1.38), ED visits (OR 0.68, 95% CI 0.35-1.31), and all-cause shocks (OR 0.58, 95% CI 0.32-1.05). The incidence of adverse events was lower in the azimilide group. Neutropenia was not observed (absolute neutrophil count Carina Blomström-Lundqvist ingår i SHIELD-2 Investigators.
- Subjects :
- Male
Azimilide
medicine.medical_specialty
Electric Countershock
030204 cardiovascular system & hematology
Neutropenia
Ventricular tachycardia
Piperazines
law.invention
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
Internal medicine
Odds Ratio
medicine
Humans
Cardiac and Cardiovascular Systems
030212 general & internal medicine
Adverse effect
Intensive care medicine
Aged
Proportional Hazards Models
Heart Failure
Kardiologi
business.industry
Hydantoins
Stroke Volume
Odds ratio
Emergency department
Middle Aged
medicine.disease
Defibrillators, Implantable
Hospitalization
Death, Sudden, Cardiac
Cardiovascular Diseases
Early Termination of Clinical Trials
Ventricular Fibrillation
Ventricular fibrillation
Tachycardia, Ventricular
Female
Emergency Service, Hospital
business
Cardiology and Cardiovascular Medicine
Anti-Arrhythmia Agents
medicine.drug
Subjects
Details
- ISSN :
- 00028703
- Volume :
- 185
- Database :
- OpenAIRE
- Journal :
- American Heart Journal
- Accession number :
- edsair.doi.dedup.....b09a85eccd1ab2be56c9bce1837ed1d8
- Full Text :
- https://doi.org/10.1016/j.ahj.2016.10.025