Treatment of hypertension in women receiving hormone replacement therapy

• US 20040034001A1
• Filed: 04/24/2003
• Published: 02/19/2004
• Est. Priority Date: 04/26/2002
• Status: Abandoned Application

• Current Assignee: Bayer Schering Pharma AG (Bayer AG)
• Original Assignee: Schering Ag (Merck & Co., Inc.)
• Inventors: Karara, Adel H
• Application Number:
  US10/421,940
• Publication Number:
  US 20040034001A1
• Time in Patent Office: Days
• US Class Current: 514/171
• 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 31/401 Proline; Derivatives thereof, e.g. captopril
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• CPC Class Codes: A61K 31/585 containing lactone rings, e.g. oxandrolone, bufalin
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 38/553 Renin inhibitors
• CPC Class Codes: A61K 38/556 Angiotensin converting enzyme inhibitors
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

A method is described to lower blood pressure and effect hormone replacement therapy (HRT) in a hypertensive woman receiving HRT, comprising administering to the woman effective amounts of drospirenone and an estrogen. In one embodiment, the woman is already taking hypertensive medicine when the method is carried out.

Claims

1. A method to lower blood pressure and effect hormone replacement therapy (HRT) in a hypertensive human female patient, comprising administering to said patient effective amounts of drospirenone (DRSP) and at least one estrogen.

2. The method of claim 1, further comprising administering antihypertensive medication to said patient.

3. The method of claim 2, wherein said patient began taking the antihypertensive medication before initiation of the administration of said DRSP and estrogen.

4. The method of claim 2, wherein said antihypertensive medication is administered in conjunction with the administration of said DRSP and estrogen.

5. The method of claim 2, wherein administration of said antihypertensive medication is initiated after initiation of administration of said DRSP and estrogen.

6. The method of claim 2, wherein said antihypertensive medication is a diuretic, an α

-adrenergic blocking agent, a β

-adrenergic blocking agent, a CNS-acting agent, an adrenergic neuron blocking agent, a vasodilator, an angiotensin I converting enzyme (ACE) inhibitor, a calcium channel blocker, a renin inhibitor or a combination thereof.

7. The method of claim 6, wherein said antihypertensive medication is an ACE inhibitor.

8. The method of claim 7, wherein said ACE inhibitor is benazepril, captopril, enalapril, enalaprilat, fosinopril, lisinopril, pentopril, quinapril, quinaprilat, ramipril, transolapril, or zofenopril.

9. The method of claim 1, wherein said DRSP and estrogen are administered orally, transdermally or by injection.

10. The method of claim 9, wherein said DRSP and estrogen are administered orally.

11. The method of claim 1, wherein said estrogen is ethinyl estradiol, mestranol, 17β

-estradiol, an ester of estradiol, estriol, estriol succinate, polyestriol phosphate, estrone, estrone sulfate, natural or synthetic estrogens or a conjugated estrogen.

12. The method of claim 1, wherein the estrogen is 17β

-estradiol.

13. The method of claim 12, wherein said 17β

-estradiol is administered in an amount ranging from 1 to 3 mg/day and the drospirenone is administered in an amount ranging from 1 to 3 mg/day.

14. The method of claim 2, wherein the estrogen is 17β

-estradiol and said antihypertensive medication is enalapril maleate.

15. The method of claim 1, wherein the patient is perimenopausal, menopausal or post-menopausal.

16. The method of claim 1, wherein said hypertension is mild or severe.

17. The method of claim 1, wherein said estrogen is ethinyl estradiol administered in an amount ranging from 0.001-0.030 mg/day, mestranol administered in an amount ranging from 5 to 25 mcg/day, estradiol administered in an amount ranging from 0.5 to 6 mg/day, polyestriol phosphate administered in an amount ranging from 2 to 8 mg/day or a conjugated estrogen administered in an amount ranging from 0.3 to 1.2 mg/day.

18. The method of claim 1, wherein said DRSP is administered in an amount ranging from 1 to 3 mg/day.

19. The method of claim 17, wherein said DRSP is administered in an amount ranging from 1 to 3 mg/day.

20. The method of claim 13, wherein said amount of DRSP is 3 mg and said amount of 17β

-estradiol is 1 mg.

21. The method of claim 13, wherein said amount of DRSP is 1 mg and said amount of 17β

-estradiol is 1 mg.