Iron deficiency in treatment of individuals at risk of cardiovascular adverse events and iron for treatment of atrial fibrillation

A technology for adverse events and atrial fibrillation, which can be used in cardiovascular system diseases, medical preparations with inactive ingredients, blood diseases, etc. It can solve problems such as occurrence and persistence, abnormal ion channel function, and prolongation of atrial conduction time

Pending Publication Date: 2022-04-05
PHARMACOSMOS HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These metabolic changes are triggered by disease conditions that predispose to AF, but are also triggered by AF itself and lead to a reduction in cellular energy in the atrium
This atrial energy fai...

Method used

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  • Iron deficiency in treatment of individuals at risk of cardiovascular adverse events and iron for treatment of atrial fibrillation
  • Iron deficiency in treatment of individuals at risk of cardiovascular adverse events and iron for treatment of atrial fibrillation
  • Iron deficiency in treatment of individuals at risk of cardiovascular adverse events and iron for treatment of atrial fibrillation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0467] Two phase III randomized, open-label, controlled safety and efficacy studies involving the use of iron isomalttoside ("IIM", Product name ) and iron sucrose ("IS", trade name )the treatment. These studies can compare the incidence of treatment-emergent cardiovascular adverse events, especially in patients with cardiovascular risk factors.

[0468] Research design

[0469] These studies were randomized, open-label, comparative studies. Individuals with iron deficiency anemia (IDA) were randomized 1:1 to one course of two treatments. Iron Isomalttoside 1000 is administered as a single dose of 1000 mg elemental iron. According to its US label, iron sucrose is administered as a slow intravenous bolus of 200 mg repeated up to 5 times to achieve a cumulative dose of 1000 mg.

[0470] Target

[0471] This study allowed to compare the incidence of protocol-defined adverse cardiovascular events in individuals with IDA and nondialysis-dependent chronic kidney disease tre...

Embodiment 2

[0665] A study was performed to determine the effect of iron on P wave dispersion.

[0666] The study was a post-hoc analysis of a randomized, double-blind, placebo-controlled trial with independent research management from the South Central Berkshire Ethics Committee, the Medicines and Healthcare Products Regulatory Agency and King's College Hospital Committee Approval. King's College London and King's College Hospitals NHS Foundation are co-sponsors. The King’s Health Partners Office of Clinical Trials monitored the trial and ensured compliance with the International Conference on Harmonization guidelines for good clinical practice and the Declaration of Helsinki. All patients obtained written informed consent. figure 1 A flowchart representing the experiment. A total of 25 chronic heart failure patients with normal sinus rhythm were enrolled in this trial, 15 of whom were randomized to receive intravenous saline placebo and 10 were randomized to receive intravenous iron ...

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Abstract

The present invention relates to the field of treating an individual at risk of cardiovascular adverse events with an intravenous iron carbohydrate complex, such as iron isomaltoside, where treatment of iron deficiency reduces the incidence or risk of cardiovascular adverse events in the individual. In another aspect, the present invention provides a method of reducing P-wave dispersion/time limit for treating an animal having atrial fibrillation or a disease associated with atrial fibrillation (e.g., heart failure, hypertension, heart valvular disease, coronary heart disease, obesity, and diabetes), the method comprises administering a therapeutically effective amount of an iron agent to the animal by oral, intramuscular or intravenous route.

Description

[0001] Related application open [0002] This application claims the priority of U.S. Provisional Patent Application No. 62 / 803,455 filed on February 9, 2019 and EP Patent Application No. EP19179820.6 filed on June 12, 2019, the entire contents of which are incorporated herein by reference. technical field [0003] The present invention relates to the field of treating iron deficiency in individuals at risk of adverse cardiovascular events using intravenous iron carbohydrate complexes. In another aspect, the present invention relates to a method of preventing and treating atrial fibrillation (AF). Background technique [0004] Iron deficiency (ID) impairs the body's ability to produce hemoglobin, a key oxygen transporter, and impairs the function of enzymes that produce key energy (ATP). Symptoms therefore include fatigue and other signs of lack of energy, such as a racing heart, shortness of breath, and chest pain. [0005] Iron deficiency anemia (IDA) occurs when iron st...

Claims

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Application Information

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IPC IPC(8): A61K33/26A61K47/36A61P7/06A61P9/00
CPCA61K47/36A61K33/26A61P7/06A61P9/00
Inventor C·C·斯特罗姆T·S·克里斯滕森T·G·迪尼斯L·L·汤姆森D·奥克诺
Owner PHARMACOSMOS HLDG
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