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Fortifier

Inactive Publication Date: 2006-09-28
TORAY IND INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0015] An object of the present invention is to provide an agent for enhancing therapeutic or prophylactic effect of administering renin-angiotensin system inhibitor on renal diseases.
[0016] The present inventors discovered that particular prostaglandin I derivatives significantly and characteristically enhance the effect of renin-angiotensin system inhibitors to suppress progression of renal disease, thereby completing the present invention.
[0020] It was proved that the excellent effect of the renin-angiotensin system inhibitors to suppress progression of renal diseases is enhanced by the present invention. Therefore, the dosages of the drugs necessary for obtaining the prescribed effects may be decreased, so that the side effects of the both drugs may be decreased and the compliance in taking these drugs may be promoted. Further, renal diseases for which the effects of the conventional renin-angiotensin system inhibitors are not sufficient may be effectively and safely treated.

Problems solved by technology

In addition, dialysis treatment has a number of problems including disorder in production and maturation of erythrocytes; emergence of complications due to accumulation of aluminum or β2-microglobulin accompanied by long-term dialysis treatment; and increase in pathologic change in cardiovascular system.
Further, in cases where renal anemia is complicated, erythropoietin is administered.
However, in spite of these therapies, the progression of renal failure cannot be well prevented at present.
However, it is known that ACE inhibitors commonly have side effects such as dry cough.
However, it has been shown that the effects of suppressing progress of renal diseases by ACE inhibitors and angiotensin II receptor antagonists are limited.
The fact that the degree of suppression is not sufficient is evident from the fact that the number of patients who are newly required to receive dialysis exceeds 30,000 in Japan and is ever-increasing year by year, in spite of the fact that ACE inhibitors and angiotensin II receptor antagonists are widely used as antihypertensive drugs.
However, the compound disclosed in this patent literature is different from prostaglandins, and the patent literature is totally silent about whether the compound enhances the suppressive effect of the inhibitors of the renin-angiotensin system against renal diseases (Japanese Laid-open Patent Application (Kokai) No. 60-23324).

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0084] To 9-week old WKY rats obtained from Charles River Japan, Inc., rabbit anti-rat glomerular basement membrane antiserum (NTS, 10-fold diluted, 3 mL / kg) was administered to induce nephritis. Two weeks later, urine and blood were collected, the animals were divided into the following 6 groups based on the protein level in urine and the blood creatinine level, and medication was started. At this time point, blood creatinine level had already been raised, so that the animals were judged as in the renal failure stage. Evaluation of the renal function was based on the blood creatinine level.

1) Control Group: solvent alone was administered, n=6

2) BPS100 Group (Comparative Example): beraprost sodium 100 μg / kg (BID: this dose was administered twice a day), n=6

3) BPS300 Group (Comparative Example): beraprost sodium 300 μg / kg (BID), n=6

4) Candesartan10 Group (Comparative Example): candesartan cilexetil 10 mg / kg (OAD: this dose was administered once a day), n=6

5) Candesartan30 G...

example 2

[0089] To 9-week old WKY rats, rabbit anti-rat glomerular basement membrane antiserum was administered to induce nephritis. At two weeks after administering the antiserum, the animals were divided into the following 4 groups and medication was started.

1) Control Group: 0.5% CMC (OAD)+distilled water (BID), n=6

2) Telmisartan Group (Comparative Example): telmisartan 40 mg / kg (OAD)+distilled water (BID), n=5

3) BPS Group (Comparative Example): 0.5% CMC (OAD)+beraprost sodium 100 μg / kg (BID), n=5

4) Telmisartan+BPS Group (the present invention): telmisartan 40 mg / kg (OAD)+beraprost sodium 100 μg / kg (BID), n=6

[0090] As shown in Table 1, in the BPS group, almost no difference in the effect to suppress the progress of renal failure was observed when compared with the control group. In the telmisartan group and telmisartan+BPS group, the progress of renal failure was suppressed, and this suppressive effect was stronger in the telmisartan+BPS group. On the other hand, when blood creat...

example 3

[0091] To 9-week old WKY rats, rabbit anti-rat glomerular basement membrane antiserum was administered to induce nephritis. At two weeks after administering the antiserum, the animals were divided into the following 4 groups and medication was started.

1) Control Group: 0.5% CMC (BID)+distilled water (BID), n=6

2) Losartan Group (Comparative Example): losartan 30 mg / kg (BID)+distilled water (BID), n=5

3) BPS Group (Comparative Example): 0.5% CMC (BID)+beraprost sodium 100 μg / kg (BID), n=6

4) Losartan+BPS Group (the present invention): losartan 30 mg / kg (BID)+beraprost sodium 100 μg / kg (BID), n=5

[0092] At six weeks after the induction, blood creatinine level was measured to assess the progress of renal failure. As shown in Table 2, in the losartan group and BPS group, no difference in the effect to suppress the progress of renal failure was observed at the dosage used herein when compared with the control group. On the other hand, in the losartan+BPS group in which both of the d...

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Abstract

An agent for enhancing therapeutic or prophylactic effect of administering an inhibitor of renin-angiotensin system, such as candesartan cilexetil, on renal diseases is disclosed. The agent comprises a specific prostaglandin I derivative such as beraprost sodium as an effective ingredient.

Description

TECHNICAL FIELD [0001] The present invention relates to a pharmaceutical for therapy or prophylaxis of renal diseases. More particularly, the present invention relates to an agent for enhancing the therapeutic or prophylactic effect against renal diseases by administration of an inhibitor of the renin-angiotensin system. BACKGROUND ART [0002] In recent years, the number of patients suffering from nephropathy tends to increase. The reasons therefor include change in living environment, aging and increase in the number of patients suffering from diabetic nephropathy accompanied by the increase in the number of patients suffering from diabetes mellitus. The number of patients whose renal function decreased to reach renal failure so that dialysis is inevitable is increasing year by year. Dialysis treatment requires the patient to attend a hospital twice or thrice a week. In addition, dialysis treatment has a number of problems including disorder in production and maturation of erythrocy...

Claims

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Application Information

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IPC IPC(8): A61K31/558A61K31/4184A61K31/5585A61K45/06A61P9/12A61P13/12C07D307/93
CPCA61K31/4184A61K31/5585A61K45/06C07D307/93A61K2300/00A61K31/401A61K31/403A61K31/404A61K31/4178A61P9/12A61P11/00A61P13/12A61P43/00A61K31/343A61K47/22
Inventor KURUMATANI, HAJIMUTAMURA, MITSUTAKA
Owner TORAY IND INC
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