Use of treprostinil to treat neuropathic diabetic foot ulcers

A neuropathic, diabetic technology, applied in the treatment of foot ulcers in patients with diabetic neuropathy, halgh DG, can solve the problem of unsuccessful treatment

Inactive Publication Date: 2008-10-15
UNITED THERAPEUTICS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While certain types of dressings can sometimes help heal the damage, these treatments are often unsuccessful

Method used

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  • Use of treprostinil to treat neuropathic diabetic foot ulcers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Treprostinil sodium (Remodulin ) Is safe and promotes diabetes and peripheral arterial disease The patient's ischemic wound healing and resting pain relief.

[0051] introduction: The purpose of this open-label study is to evaluate the safety of a stable prostaglandin analog, treprostinil sodium, in 10 patients with PAD, diabetes, and inoperable ischemic foot ulcers. And effectiveness.

[0052] method: Treprostinil sodium was given by continuous subcutaneous infusion, starting at 2.5ng / Kg / min and dripping to the highest tolerated dose, for 12 weeks. Monitor patients' adverse reactions, wound healing, skin perfusion pressure, and ischemic resting pain.

[0053] result: Seven patients have completed the experiment so far. No serious adverse reactions caused by treprostinil occurred during the experiment. The only reported drug-related side effect was mild to moderate pain at the infusion site. Two patients were completely cured. Two patients were partially cured. ...

Embodiment 2

[0056] Use Treprostinil sodium (Remodulin ) Enhance blood around trauma in ischemic limbs Oxygen quantification and laser Doppler signal

[0057] introduction: In diabetic patients with recalcitrant lower extremity trauma, a case-control trial was conducted by continuous subcutaneous infusion to check treprostinil sodium (Remodulin ). The known vasodilatation and platelet aggregation inhibitor properties of treprostinil sodium ensure that it can be used as an adjuvant drug in wound healing of ischemic limbs. The primary endpoint is wound healing and limb salvation. Among the secondary endpoints are resting ring trauma percutaneous oximetry (TcPO2) and laser Doppler analysis (LD), as well as the response of TcPO2 and LD to normal pressure oxygen or hyperbaric oxygen stimulation. If treprostinil sodium reduces the inflow resistance to the distal side of the capillary sphincter connecting the arterioles, between the trauma center with low oxygen content and the inflow blood...

Embodiment 3

[0065] Give Treprostinil to people with diabetic neuropathy and foot ulcers

[0066] Treprostinil was administered to patients with diabetic neuropathy who had at least one ulcer (ie, small ulcer or small area of ​​tissue gangrene) on the foot in escalating doses over 12 weeks. The therapeutic drug is delivered through a small pump connected to a catheter placed under the skin. In this way, escalating doses of Treprostinil are continuously subcutaneously infused into the patient for a long time.

[0067] Specifically, Treprostinil sodium (REMODULIN) was administered subcutaneously using a standard micro-infusion, positive pressure infusion pump designed for subcutaneous drug delivery (Mini-Med) ) 1.0mg / mL formulation. The patient received an initial dose of 2.5 ng / kg / min of study drug. If the patient does not tolerate the 2.5ng / kg / min dose (such as persistent headache, nausea, vomiting, restlessness, anxiety, or severe pain at the infusion site that cannot be adequately treated ...

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Abstract

The present invention describes novel methods for using 9-deoxy-2', 9-alpha-methano-3-oxa-4,5,6-trinor-3,7-(1',3'-interphenylene)-13,14-dihydro-prostaglandin F1 (also known as Treprostinil) or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and / or prevention of foot ulcers in subjects with diabetic neurophathy. The invention also relates to kits for treatment and / or prevention of foot ulcers, comprising an effective amount of treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.

Description

[0001] Cross-references to related patent applications [0002] This application claims the priority of U.S. Provisional Patent Application No. 60 / 561,157 filed on April 12, 2004, the entire content of which is incorporated herein by reference. Background of the invention [0003] The present invention relates to 9-deoxy-2',9-α-methylene-3-oxa-4,5,6-trinor-3,7-(1',3'-interleaved phenylene (interphenylene))-13,14-dihydro-prostaglandin F 1 (Hereinafter referred to as "Treprostinil") or a derivative thereof, or a pharmaceutically acceptable salt thereof for the treatment of, for example, use of foot ulcers in patients with diabetic neuropathy. The invention also relates to a kit for this purpose. [0004] Treprostinil, also known as UT-15, is a known compound disclosed in Example 33 of US Patent No. 4,306,075. Treprostinil is prostaglandin F 1 A synthetic analogue of. The various compounds of this patent have activities including 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): A61K31/192A61P17/02A61K31/557
CPCA61K31/557A61P17/02A61P29/00A61P43/00A61P3/10A61K31/192
Inventor M·沃德R·A·杰夫斯D·斯特鲁特曼
Owner UNITED THERAPEUTICS CORP
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