USE OF PIMOBENDAN FOR THE REDUCTION OF HEART SIZE AND/OR THE DELAY OF ONSET OF CLINICAL SYMPTOMS IN PATIENTS WITH ASYMPTOMATIC HEART FAILURE DUE TO MITRAL VALVE DISEASE

• US 20170290829A1
• Filed: 04/03/2017
• Published: 10/12/2017
• Est. Priority Date: 04/06/2016
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim Vetmedica GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Vetmedica GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: SCHUMMER, Christoph, JOENS, Olaf
• Granted Patent: US 10,537,570 B2
• Time in Patent Office: Days
• 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 31/50 Pyridazines; Hydrogenated pyridazines
• CPC Class Codes: A61K 31/501 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 31/635 having a heterocyclic ring, e.g. sulfadiazine
• CPC Class Codes: A61K 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

Abstract

The invention relates to pimobendan for use in a method of reducing the heart size and/or delaying the onset of clinical symptoms in a patient suffering from asymptomatic (occult, preclinical) heart failure, preferably congestive heart failure, due to mitral valve disease (MVD), and/or delaying the onset of heart failure, preferably congestive heart failure, in a patient suffering from asymptomatic (occult, preclinical) heart failure, preferably congestive heart failure, due to mitral valve disease (MVD), wherein the patient is preferably a mammal, more preferably a human, a dog, a cat or a horse, and most preferably a dog.

Claims

1. A method for the reduction of heart size and/or delaying the onset of clinical symptoms in a patient suffering from asymptomatic (occult, preclinical) heart failure due to mitral valve disease (MVD), and/or asymptomatic (occult, preclinical) congestive heart failure due to myxomatous mitral valve disease (MMVD), and/or delaying the onset of heart failure in a patient suffering from asymptomatic (occult, preclinical) heart failure due to mitral valve disease (MVD), and/or delaying the onset of congestive heart failure in a patient suffering from asymptomatic (occult, preclinical) heart failure due to myxomatous mitral valve disease (MMVD) comprising administration of a pharmaceutical composition/medicament comprising pimobendan.

3. The method of claim 1 or 2, wherein the asymptomatic (occult, preclinical) heart failure due to mitral valve disease (MVD), and/or asymptomatic (occult, preclinical) congestive heart failure due to myxomatous mitral valve disease (MMVD) is of stage ISACHC Class I, preferably ISACHC Class IA or Class IB, more preferably of stage ISACHC Class IB, NYHA Class I and ACVIM stage B2.

4. The method of claim 1, wherein the administration of pimobendan results in a reduction of the heart size of the already pathologically enlarged heart of the patient of at least 5%, as compared to a baseline prior to pimobendan treatment.

5. The method of claim 1, wherein the administration of pimobendan effects a prolongation of the time of survival of the patient as compared to placebo treatment or non-pimobendan treatment, of at least 30 days.

6. The method of claim 1, wherein the administration of pimobendan effects a prolongation of the preclinical phase without exhibiting clinical symptoms of congestive heart failure, and/or effects a delay of onset of (clinical symptoms of) congestive heart failure, and/or increases the survival time of the treated patients as compared to placebo treatment, and/or improves the quality of life of the treated patients, and/or leads to a reduction of heart size of the treated patients as compared to baseline (i.e. before start of treatment), and/or improves cardiac function/output in the treated patients, and/or reduces sudden cardiac death/euthanasia of patients due to cardiac reasons, and/or reduces the risk of reaching congestive heart failure.

7. The method claim 1, wherein the patient is a mammal selected from the group consisting of:

a human, a dog, a cat, or a horse.

8. The method of claim 1, wherein pimobendan is administered in a daily dose of 0.2 mg/kg to 0.6 mg/kg bodyweight.

9. The method of claim 8, wherein the daily pimobendan dose is administered as two doses of 0.1 mg/kg to 0.3 mg/kg bodyweight, wherein two doses of 0.1 mg/kg to 0.3 mg/kg bodyweight are administered every 12 hours, or two doses of 0.25 mg/kg bodyweight are administered every 12 hours.

10. The method of claim 1, wherein pimobendan is administered orally or parenterally, wherein if administered orally, pimobendan is in the form of a tablet or capsule.

11. The method of claim 1, wherein pimobendan is administered before, during or after administration of one or more additional active pharmaceutical ingredients selected from the group consisting of ACE inhibitors, preferably benazepril;

and diuretics, preferably furosemide.

12. The method of claim 11, wherein pimobendan is administered concomitantly with benazepril and/or furosemide.

2. A method for the reduction of heart size and delaying the onset of clinical symptoms in a patient suffering from asymptomatic (occult, preclinical) heart failure due to mitral valve disease (MVD), and/or asymptomatic (occult, preclinical) congestive heart failure due to myxomatous mitral valve disease (MMVD), and/or delaying the onset of heart failure in a patient suffering from asymptomatic (occult, preclinical) heart failure due to mitral valve disease (MVD), and/or delaying the onset of congestive heart failure in a patient suffering from asymptomatic (occult, preclinical) heart failure due to myxomatous mitral valve disease (MMVD) comprising administration of a pharmaceutical composition/medicament comprising pimobendan.