IP Library Granted Patent US 8,592,439
Granted Patent B2
US 8,592,439 · App. 13/057,492 · Granted Nov 26, 2013

Long-term treatment of symptomatic heart failure

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Quick Facts
Patent No.
US 8,592,439
App. No.
13/057,492
Granted
Nov 26, 2013
Kind
B2
Abstract

The main object here is the use of omega-3 polyunsaturated fatty acids (as ethyl esters, hereinafter called “n-3 PUFA”) as a medicament, either alone or in combination with other therapeutic agents, for reducing mortality for a cardiovascular cause, in particular arrhythmia or for reducing hospitalization for any cause, in particular a cardiovascular cause and for the daily administration to patients with symptomatic heart failure (HF) for more than 3.5 years.

Claims (10)

1. A method of reducing mortality and hospitalization for cardiovascular causes comprising:

administering an effective amount of a composition comprising omega-3 polyunsaturated fatty acids (n-3 PUFA) for more than 3.5 years to patients with symptomatic HF having left ventricular ejection fraction <40%, diabetes or total cholesterol <200 mg/dl, wherein said n-3 PUFA is a mixture of fatty acids having a content of EPA and DHA comprised between 75% and 95% by weight on the total fatty acids weight.

2. Method of claim 1 , wherein said total cholesterol is ≦188 mg/dl.

3. Method of claim 1 , wherein the n-3 PUFA is a mixture of fatty acids having a content in EPA and DHA of at least 85% by weight on the total fatty acids weight and the total content of n-3 PUFA is at least 90% by weight on the total fatty acids weight.

4. Method of claim 3 , wherein the n-3 PUFA is a mixture of ethyl esters of EPA and DHA in a ratio comprised between 0.9 and 1.5 and the content of EPA ethyl esters is between 40 and 51% and the content of DHA ethyl ester is between 34 and 45 by weight on the total fatty acids weight.

5. Method of claim 1 , wherein said effective amount comprises 1 g daily doses of n-3 PUFA.

6. Method of claim 1 , wherein n-3 PUFA is administered in combination, separately, substantially simultaneously or sequentially with one or more therapeutic agent.

7. Method of claim 6 , wherein the therapeutic agent is selected from the group consisting of: ACE-inhibitors, NEP-inhibitors, ACE/NEP inhibitors, angiotensin I converting enzyme inhibitors, diuretics, positive inotropic drugs, phosphodiesterase inhibitors, arteriolar and venular vasodilators, beta blockers and digital glycosides, or a mixture thereof.

8. Method of claim 6 , wherein the therapeutic agent is a statin.

9. Method of claim 8 , wherein the statin is selected from the group consisting of: simvastatin, lovastatin, fluvastatin, pravastatin, atorvastatin, cerivastatin, rovastatin and rosuvastatin.

Assignments (4)
CHANGE OF ADDRESS Recorded Oct 15, 2019
From: ALFASIGMA S.P.A.
To: ALFASIGMA S.P.A.
Reel/Frame 050727/0652 →
MERGER Recorded Nov 14, 2017
From: SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
To: ALFASIGMA S.P.A.
Reel/Frame 044760/0906 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2011
From: SIXTERPHARMA SRL
To: SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
Reel/Frame 027395/0378 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 5, 2011
From: CAVAZZA, CLAUDIO; CACCIA, MARIA GIOVANNA
To: SPA SOCIETA PRODOTTI ANTIBIOTICI S.P.A.; SIXTERPHARMA S.R.L.
Reel/Frame 026077/0794 →