Method to slow ventricular rate
Inventors
Belardinelli, Luiz • Narasimhan, Rangachari • Schuler, Carlos
Assignees
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Publication Number
US-10744087-B2
Publication Date
2020-08-18
Expiration Date
Abstract
Disclosed herein are methods, formulations, and kits for treating or preventing a heart condition, e.g., cardiac arrhythmia, e.g., atrial arrhythmia, using selective β1 adrenergic receptor blockers. Also disclosed herein are methods, formulations, and kits for treating a heart condition via inhalation or intranasal spray administration of selective β1 adrenergic receptor blocker and class I antiarrhythmic agent.
Core Innovation
The described invention relates to treating a subject or patient suffering from atrial arrhythmia by administering, via inhalation, a therapeutically effective amount of a β1-selective adrenergic receptor blocker and a therapeutically effective amount of a class I antiarrhythmic agent. When both inhaled therapeutically effective amounts are administered to an experimental subject in a clinical study, the combination induces a faster cardioversion of the atrial arrhythmia than either agent alone administered via inhalation.
The disclosed approach requires that inhalation administration of both agents slows atrioventricular node conduction during cardioversion. It further discloses that the combination induces a greater reduction in average ventricular rate during cardioversion than either agent alone, with electrophysiologic endpoints including PR interval prolongation measured by electrocardiograph.
Representative β1-selective adrenergic receptor blockers and class I antiarrhythmic agents include metoprolol, metoprolol tartrate, nebivolol, d-nebivolol, and flecainide or flecainide acetate. The disclosure also describes inhalation delivery using aerosolization, including nebulizer and jet nebulizer delivery, as well as pharmaceutical formulations, kits, and unit dose or single-solution delivery concepts [procedural detail omitted for safety].
Claims Coverage
The document contains two independent claims. Each independent claim requires a combination inhalation method using a β1-selective adrenergic receptor blocker plus a class I antiarrhythmic agent, with comparative performance in a clinical study and an electrophysiologic requirement of slowing atrioventricular node conduction during cardioversion.
Inhalation combination for faster cardioversion and av node slowing
Administer to a subject suffering from atrial arrhythmia via inhalation a therapeutically effective amount of a β1-selective adrenergic receptor blocker and a therapeutically effective amount of a class I antiarrhythmic agent, wherein the combined inhaled administration induces a faster cardioversion in an experimental subject as compared to either agent alone in a clinical study, and wherein the inhalation administration of both agents slows atrioventricular node conduction during said cardioversion.
Inhalation combination for cardioversion with greater ventricular rate reduction and av node slowing
Administer to a patient suffering from atrial arrhythmia via inhalation a therapeutically effective amount of a β1-selective adrenergic receptor blocker and a therapeutically effective amount of a class I antiarrhythmic agent, wherein the combined inhaled administration induces cardioversion and induces a greater reduction in average ventricular rate during said cardioversion in an experimental subject as compared to either agent alone in a clinical study, and wherein the inhalation administration of both agents slows atrioventricular node conduction during said cardioversion.
Across both independent claims, the core claim coverage is the combined inhalation administration of a β1-selective adrenergic receptor blocker and a class I antiarrhythmic agent, requiring improved cardioversion performance in comparative clinical study conditions and requiring that the combination slows atrioventricular node conduction during cardioversion.
Stated Advantages
Faster cardioversion of atrial arrhythmia when both agents are administered via inhalation compared to administering either agent alone.
Slowing atrioventricular node conduction during cardioversion when both agents are administered via inhalation.
Greater reduction in average ventricular rate during cardioversion compared to administering either agent alone.
Documented Applications
Inhalation treatment of atrial arrhythmia, including atrial fibrillation and atrial flutter, in a subject or patient suffering from atrial arrhythmia.
Use in a clinical study context to compare combined inhalation therapy versus single-agent inhalation therapy for cardioversion and ventricular rate reduction.
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