COMBINATION OF DRONEDARONE WITH AT LEAST ONE DIURETIC, AND THERAPEUTIC USE THEREOF

• US 20110136899A1
• Filed: 10/13/2010
• Published: 06/09/2011
• Est. Priority Date: 04/17/2008
• Status: Abandoned Application

• Current Assignee: Sanofi
• Original Assignee: Sanofi-Aventis (Sanofi )
• Inventors: RADZIK, Davide, VAN EICKELS, Martin
• Application Number:
  US12/903,374
• Publication Number:
  US 20110136899A1
• Time in Patent Office: Days
• US Class Current: 514/469
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

The disclosure relates to a combination of dronedarone or a pharmaceutically salt thereof with at least one diuretic, and to the therapeutic use thereof.

Claims

1. A method of preventing cardiovascular hospitalizations or mortality in a patient having a history of atrial fibrillation or atrial flutter, comprising administering an effective amount of dronedarone to said patient in combination with one or more diuretic.

4. The method according to anyone of claims 1 to 3, wherein said diuretic is a non-potassium-sparing diuretic.

5. The method according to claim 4, wherein hypokalaemia is prevented.

6. The method according to anyone of claims 1 to 3, wherein the patient also exhibits at least one risk factors selected from the group consisting of:

hypertension,

diabetes,

history of cerebral stroke or of systemic embolism,

left atrial diameter greater than or equal to 50 mm measured by echocardiography, and

left ventricular ejection fraction less than 40%, measured by two-dimensional echography.

7. The method according to any one of claims 1 to 3, wherein the patient also exhibits at least one pathology selected from the group consisting of:

hypertension,

underlying structural heart disease,

tachycardia,

coronary disease,

non-rheumatic heart valve disease,

dilated cardiomyopathy of ischemic origin,

catheter ablation of atrial fibrillation or flutter,

supraventricular tachycardia other than atrial fibrillation or flutter,

history of valve surgery,

non-ischemic dilated cardiomyopathy,

hypertrophic cardiomyopathy,

rheumatic valve disease,

sustained ventricular tachycardia,

congenital cardiopathy,

catheter ablation for tachycardia other than for atrial fibrillation or flutter,

ventricular fibrillation,

and/or at least one cardiac device chosen from;

a cardiac stimulator, and

an implantable defibrillator (“

ICD”

).

8. The method according to any one of claims 1 to 3, wherein the dose of dronedarone administered per day, orally, is up to 800 mg, taken in one or more intakes.

2. A method for regulating the potassium level in the blood of a patient, comprising administering an effective amount of dronedarone to said patient in combination with at least one diuretic.

3. A method for treating atrial fibrillation or atrial flutter in patient with a history of atrial fibrillation or atrial flutter, comprising administering an effective amount of dronedarone to said patient in combination with one or more diuretic.

9. A combination of dronedarone, or a pharmaceutically acceptable salt thereof, and at least one diuretic, with the exclusion of furosemide, of hydrochlorothiazide, of metolazone, of amiloride, of spironolactone and of mannitol.

10. The combination according to claim 9, wherein said at least one diuretic is a non-potassium-sparing diuretic, with the exclusion of furosemide, of hydrochlorothiazide, of metolazone and of mannitol.