Pharmaceutical composition useful for the treatment of cardiovascular diseases

• US 5,571,834 A
• Filed: 01/25/1994
• Issued: 11/05/1996
• Est. Priority Date: 07/15/1988
• Status: Expired due to Fees

• Current Assignee: Zambon Group SPA (GEFIM SRL)
• Original Assignee: Zambon Group SPA (GEFIM SRL)
• Inventors: Licciardello, Luciano, Casagrande, Cesare
• Primary Examiner(s): Goldberg, Jerome D.
• Application Number:
  US08/186,177
• Time in Patent Office: 1,015 Days
• Field of Search: 514/423, 514/548
• US Class Current: 514/423
• 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 31/195 having an amino group
• CPC Class Codes: A61K 31/22 of acyclic acids, e.g. pravastatin
• CPC Class Codes: A61K 31/395 having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 31/495 having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 31/535 having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/556 Angiotensin converting enzyme inhibitors
• 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 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

A pharmaceutical composition is described comprising ibopamine and an ACE-inhibitor.

Such composition is useful in the treatment of cardiovascular diseases, more particularly of hypertension and heart insufficiency even when the latter is associated with or caused by hypertension.

Claims

1. A pharmaceutical composition useful for treating cardiovascular disease and comprising a pharmaceutically-acceptable carrier and an effective enhanced amount combination of a) ibopamine or a pharmaceutically-acceptable salt thereof and b) an enalapril or pharmaceutically-acceptable salt thereof.

2. A composition according to claim 1 wherein component (a) is the hydrochloride salt of ibopamine.

3. A composition according to claim 1 wherein the amount of (a) is sufficient to overcome drawbacks or side effects of (b).

4. A pharmaceutical composition of claim 1 wherein the amount of component (b) is sufficient to enhance a blood pressure drop induced by component (a) in hypertensive patients.

5. A composition according to claim 1 wherein the amount of component (b) is from 0.2 to the standard dose of that component for each 50 to 100 mg of ibopamine or the equivalent amount of a pharmaceutically-acceptable acid-addition salt thereof.

6. A method for treating cardiovascular disease comprising administering an effective amount of a composition according to claim 1 to a subject suffering from hypertension, heart insufficiency or heart insufficiency associated with hypertension.

7. In cardiovascular therapy which comprises administering enalapril or a pharmaceutically-acceptable salt thereof to a patient in need of such therapy, the improvement which comprises at least substantially concurrently administering an enhancing effective amount of ibopamine or a pharmaceutically-acceptable salt thereof to the patient.

8. The therapy of claim 7 for treating a patient afflicted with hypertension.

9. The therapy of claim 7 for treating a patient afflicted with heart insufficiency.

10. The theray of claim 7 wherein enalapril or a pharmaceutically-acceptable salt thereof is administered in an amount within a range of from a standard dose thereof to 1/5 of said standard dose.

11. The therapy of claim 7 wherein the effective amount ibopamine or a pharmaceutically-acceptable salt thereof is within the range of from 50 to 100 mg.

12. A method of reducing side effects in cardiovascular therapy with enalapril or a pharmaceutically-acceptable salt thereof which comprises jointly administering an effective amount of ibopamine or a pharmaceutically-acceptable salt thereof to a patient undergoing such therapy.

13. A method of claim 12 of counteracting an increase of azotemia or of plasma creatinine in treating cardiovascular disease in a patient to whom enalapril or a pharmaceutically-acceptable salt thereof is administered, which method comprises concurrent administration of an effective amount of ibopamine or a pharmaceutically-acceptable salt thereof.

14. A method of claim 12 wherein the patient is afflicted with hypertension.

15. A method of claim 12 wherein the patient is afflicted with heart insufficiency.