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Use of treprostinil to treat and prevent ischemic lesions

A treprostinil, ischemic technology, applied in the field of treprostinil or its derivatives, can solve the problem of unsuccessful treatment

Inactive Publication Date: 2010-02-17
UNITED THERAPEUTICS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although certain types of dressings can sometimes help to aid in the healing of the lesions, these treatments are often unsuccessful

Method used

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  • Use of treprostinil to treat and prevent ischemic lesions
  • Use of treprostinil to treat and prevent ischemic lesions
  • Use of treprostinil to treat and prevent ischemic lesions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Administration of treprostinil to persons with scleroderma with ischemic lesions of the digits

[0056] Scleroderma patients with at least one lesion (ie, a small ulcerated or gangrene area) present on the hands or fingers were given 12-week increasing doses of treprostinil. The drug is delivered by a small pump connected to a catheter placed under the skin. In this manner, patients are given increasing doses of treprostinil by long-term continuous subcutaneous infusion.

[0057] Specifically, a 1.0 mg / mL treprostinil sodium formulation (REMODULIN ). Patients received the initial dose of study drug at 2.5 ng / kg / min. If, a given patient cannot tolerate the 2.5 ng / kg / min dose (e.g., persistent headache, nausea, vomiting, restlessness, anxiety, or severe pain at the infusion site, and cannot be adequately treated with medical or topical therapy) control), then the dose was reduced to 1.25ng / kg / min. During 1 week, patients were maintained on 2.5 ng / kg / min (or, if 2.5 ...

Embodiment 2

[0061] Treprostinil (Remodulin ) for the treatment and prevention of ischemic lesions of the digits in patients with systemic sclerosis

[0062] Ischemic lesions (DIL) of the digits occur in up to 35% of patients with systemic sclerosis and are extremely painful, often progressing to necrosis requiring amputation. The aim of this study was to evaluate the effect of treprostinil on the healing and prevention of DIL in patients with systemic sclerosis.

[0063] method:

[0064] This study included 12 subjects with diffuse or localized scleroderma with at least one DIL that had been present for 2 months or more (Table 1). Subjects who completed the study were treated with treprostinil for 12 weeks and followed for an additional 8 weeks after drug discontinuation ( figure 1 ).

[0065] Table 1 Initial Patient Demographic Information

[0066]

[0067] 1 If you have quit smoking for more than 10 years, it is a long history of smoking.

[0068] 2 Risk factors evaluated ...

Embodiment 3

[0075] Treprostinil Sodium Relieves Symptoms of Severe Berger's Disease

[0076] background

[0077] Berger's disease (thromboangiitis oliterans or TAO) is a clinical syndrome characterized by the formation of segmental thrombotic occlusions in medium and arterioles. The disease can be distinguished clinically and pathologically from atherosclerotic disease. Histopathologic features may vary with the duration of the disease. In chronic patients or end stages of the disease, only organized thrombi and fibrotic vessels are seen. During all stages of the disease, the normal structure of the blood vessel walls usually remains intact. Angiographic features of Berger's disease are small and medium vessel involvement, segmental occlusive lesions, more severe disease distally, and collateralization (corkscrew collaterals) around the occluded area. Olin, Jeffery W., Current Concepts: Thromboangiitis Obliterans (Buerger's Disease), N. Engl. J. Med., Vol. 343(12), 864-869 (Septembe...

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Abstract

The present invention relates to a use of treprostinil to treat and prevent ischemic lesions. The present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and / or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease. Raynaud'sdisease, Raynaud's phenomenon and / or other conditions that cause such lesions. The invention also relates to kits for treatment and / or prevention of ischemic lesions, comprising an effective amount ofTreprostinil or its derivative, or a pharmaceutically acceptable salt thereof.

Description

[0001] This application is a divisional application submitted based on the application date of December 16, 2004, application number 200480041780.9, and invention name "Use of Treprostinil for Treatment and Prevention of Ischemic Damage". technical field [0002] The present invention relates to treprostinil (Treprostinil) or its derivative, or its pharmaceutically acceptable salt treatment and / or prevention caused by scleroderma, Burger's disease, Raynaud's disease, Raynaud's phenomenon or other condition Caused ischemic lesions, such as ulcerative and necrotic lesions of digits (fingers and toes). The invention also relates to kits for this purpose. Background technique [0003] Treprostinil, also known as UT-15, is a known compound disclosed in Example 33 of US Patent No. 4,306,075. Treprostinil is epoprostenol, a synthetic analogue of prostaglandin F1. The activities of the various compounds of this patent include inhibition of smooth muscle cell proliferation, inhibit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/19A61K31/5575A61P9/10A61P17/00A61P17/02A61P29/00A61K31/191A61K31/201A61K31/557
CPCA61K31/191A61K31/201A61K31/557A61P17/00A61P17/02A61P25/04A61P29/00A61P37/02A61P43/00A61P7/02A61P9/00A61P9/08A61P9/10A61K31/185
Inventor M·沃德R·A·杰夫斯R·洛斯奇诺D·斯特鲁特曼K·布龙施泰因
Owner UNITED THERAPEUTICS CORP
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