# US 2021/0330624 A1 · Compositions and methods for treating or preventing diseases and/or disorders caused by exposure to air pollution > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330624 A1 - Document ID: US20210330624A1 - Status: Published application - Kind: A1 - Application number: 17/280,092 - Filed: 2019-09-25 - Published: 2021-10-28 - Earliest claimed: 2018-09-26 - Assignees: Amarin Pharmaceuticals Ireland Limited - Applicants: Amarin Pharmaceuticals Ireland Limited - Inventors: Craig Granowitz; Sephy Philip - Web page: https://patentgrep.com/patent/US20210330624A1 ## CPC - A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557) - A61K 31/232: having three or more double bonds, e.g. etretinate - A61P 9/00: Drugs for disorders of the cardiovascular system - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract In various embodiments, the present disclosure provides compositions and methods for treating and/or preventing diseases and disorders caused by exposure to air pollution and/or inhalation of particulate matter, such as oxidative stress, endothelial dysfunction, narrowing and/or thickening of arteries, and/or inflammation. ## Claims ### Claim 1 A method of treating or preventing oxidative stress, endothelial dysfunction, narrowing and/or thickening of arteries, and/or inflammation induced by inhalation of particulate matter in a subject, the method comprising administering to the subject a composition comprising about 4 g of eicosapentaenoic acid per day. ### Claim 2 (depends on 1) The method of claim 1, wherein the particulate matter is less than about 10 μm and greater than about 2.5 μm in diameter. ### Claim 3 (depends on 1) The method of claim 1, wherein the particulate matter is less than or equal to about 2.5 μm in diameter. ### Claim 4 (depends on 1) The method of claim 1, where in the particulate matter is less than about 0.1 μm in diameter. ### Claim 5 (depends on 1) The method of claim 1, wherein the inflammation is pulmonary and/or systemic inflammation. ### Claim 6 (depends on 1) The method of claim 1, wherein administration of the composition reduces a risk of atherosclerotic cardiovascular disease in the subject. ### Claim 7 (depends on 1) The method of claim 1, wherein the subject experiences a reduction in blood pressure levels. ### Claim 8 (depends on 1) The method of claim 1, wherein the subject experiences a reduction in insulin resistance. ### Claim 9 (depends on 1) The method of claim 1, wherein the subject experiences a reduction in an inflammatory biomarker selected from the group consisting of vascular endothelial growth factor (VEGF), tumor necrosis factor-α (TNF-α), monocyte chemoattractant protein-1 (MCP-1), interleukin-1β (IL-1β), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cellular adhesion molecule-1 (sVCAM-1), high sensitivity reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), and circulating monocyte levels. ### Claim 10 (depends on 1) The method of claim 1, wherein the subject experiences a reduction in a metabolic biomarker selected from the group consisting of total cholesterol (TC), very low dense lipoprotein cholesterol (VLDL-C), low dense lipoprotein cholesterol (LDL-C), high dense lipoprotein cholesterol (HDL-C), non-high dense lipoprotein cholesterol (non-HDL-C), HDL-C functionality, apolipoprotein B (Apo B), interleukin-6 (IL-6), apolipoprotein A-1 (Apo A-1), and homeostasis model assessment of insulin resistance (HOMA-IR) levels. ### Claim 11 (depends on 1) The method of claim 1, wherein the subject experiences a reduction in an oxidative biomarker selected from the group consisting of lipid oxidation, lipid peroxidation, lipid hydroperoxidation, malondialdehyde, prostaglandin-2α (PGF-2α), platelet-derived growth factor (PDGF), and antioxidant potential levels. ### Claim 12 (depends on 1) The method of claim 1, wherein the subject exhibits beneficial effects in heart rate and/or rhythm following administration of the composition. ### Claim 13 (depends on 12) The method of claim 12, wherein the beneficial effects include a reduction in arrhythmia suppression levels, ventricular arrhythmia rates, or heart rate or an increase in heart rate variability. ### Claim 14 (depends on 1) The method of claim 1, wherein the composition is administered to the subject in 1 to 4 dosage units per day. ### Claim 15 (depends on 1) The method of claim 1, wherein the eicosapentaenoic acid comprises at least about 96 wt.% of all omega-3 fatty acids in the composition. ### Claim 16 A method of treating or preventing oxidative stress, endothelial dysfunction, narrowing and/or thickening of arteries, and/or inflammation induced by long term and/or short term exposure to air pollution in a subject, the method comprising administering to the subject a composition comprising about 4 g of eicosapentaenoic acid per day. ### Claim 17 (depends on 16) The method of claim 16, wherein the air pollution contains particulate matter. ### Claim 18 (depends on 16) The method of claim 16, wherein the particulate matter is less than about 10 μm and greater than about 2.5 μm in diameter. ### Claim 19 (depends on 16) The method of claim 16, wherein the particulate matter is less than or equal to about 2.5 μm in diameter. ### Claim 20 (depends on 16) The method of claim 16, where in the particulate matter is less than about 0.1 μm in diameter. ### Claim 21 (depends on 16) The method of claim 16, wherein the inflammation is pulmonary and/or systemic inflammation. ### Claim 22 (depends on 16) The method of claim 16, wherein administration of the composition reduces a risk of atherosclerotic cardiovascular disease in the subject. ### Claim 23 (depends on 16) The method of claim 16, wherein the subject experiences a reduction in blood pressure levels. ### Claim 24 (depends on 16) The method of claim 16, wherein the subject experiences a reduction in insulin resistance. ### Claim 25 (depends on 16) The method of claim 16, wherein the subject experiences a reduction in an inflammatory biomarker selected from the group consisting of vascular endothelial growth factor (VEGF), tumor necrosis factor-α (TNF-α), monocyte chemoattractant protein-1 (MCP-1), interleukin-1β (IL-1β), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cellular adhesion molecule-1 (sVCAM-1), high sensitivity reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), and circulating monocyte levels. ### Claim 26 (depends on 16) The method of claim 16, wherein the subject experiences a reduction in a metabolic biomarker selected from the group consisting of total cholesterol (TC), very low dense lipoprotein cholesterol (VLDL-C), low dense lipoprotein cholesterol (LDL-C), high dense lipoprotein cholesterol (HDL-C), non-high dense lipoprotein cholesterol (non-HDL-C), HDL-C functionality, apolipoprotein B (Apo B), interleukin-6 (IL-6), apolipoprotein A-1 (Apo A-1), and homeostasis model assessment of insulin resistance (HOMA-IR) levels. ### Claim 27 (depends on 16) The method of claim 16, wherein the subject experiences a reduction in an oxidative biomarker selected from the group consisting of lipid oxidation, lipid peroxidation, lipid hydroperoxidation, malondialdehyde, prostaglandin-2α (PGF-2α), platelet-derived growth factor (PDGF), and antioxidant potential levels. ### Claim 28 (depends on 16) The method of claim 16, wherein the subject exhibits beneficial effects in heart rate and/or rhythm following administration of the composition. ### Claim 29 (depends on 28) The method of claim 28, wherein the beneficial effects include a reduction in arrhythmia suppression levels, ventricular arrhythmia rates, or heart rate or an increase in heart rate variability. ### Claim 30 (depends on 16) The method of claim 16, wherein the composition is administered to the subject in 1 to 4 dosage units per day. ### Claim 31 (depends on 16) The method of claim 16, wherein the eicosapentaenoic acid comprises at least about 96 wt.% of all omega-3 fatty acids in the composition. ### Claim 32 A method of treating or preventing oxidative stress, endothelial dysfunction, narrowing and/or thickening of arteries, and/or inflammation induced by inhalation of particulate matter in a subject, the method comprising administering to the subject a composition comprising about 4 g of eicosapentaenoic acid per day, wherein administration of the composition reduces a risk of atherosclerotic cardiovascular disease in the subject. ### Claim 33 (depends on 32) The method of claim 32, wherein the air pollution contains particulate matter. ### Claim 34 (depends on 32) The method of claim 32, wherein the particulate matter is less than about 10 μm and greater than about 2.5 μm in diameter. ### Claim 35 (depends on 32) The method of claim 32, wherein the particulate matter is less than or equal to about 2.5 μm in diameter. ### Claim 36 (depends on 32) The method of claim 32, where in the particulate matter is less than about 0.1 μm in diameter. ### Claim 37 (depends on 32) The method of claim 32, wherein the inflammation is pulmonary and/or systemic inflammation. ### Claim 38 (depends on 32) The method of claim 32, wherein the subject experiences a reduction in blood pressure levels. ### Claim 39 (depends on 32) The method of claim 32, wherein the subject experiences a reduction in insulin resistance. ### Claim 40 (depends on 32) The method of claim 32, wherein the subject experiences a reduction in an inflammatory biomarker selected from the group consisting of vascular endothelial growth factor (VEGF), tumor necrosis factor-α (TNF-α), monocyte chemoattractant protein-1 (MCP-1), interleukin-1β (IL-1β), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cellular adhesion molecule-1 (sVCAM-1), high sensitivity reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), and circulating monocyte levels. ### Claim 41 (depends on 32) The method of claim 32, wherein the subject experiences a reduction in metabolic biomarker selected from the group consisting of total cholesterol (TC), very low dense lipoprotein cholesterol (VLDL-C), low dense lipoprotein cholesterol (LDL-C), high dense lipoprotein cholesterol (HDL-C), non-high dense lipoprotein cholesterol (non-HDL-C), HDL-C functionality, apolipoprotein B (Apo B), interleukin-6 (IL-6), apolipoprotein A-1 (Apo A-1), and homeostasis model assessment of insulin resistance (HOMA-IR) levels. ### Claim 42 (depends on 32) The method of claim 32, wherein the subject experiences a reduction in an oxidative biomarker selected from the group consisting of lipid oxidation, lipid peroxidation, lipid hydroperoxidation, malondialdehyde, prostaglandin-2α (PGF-2α), platelet-derived growth factor (PDGF), and antioxidant potential levels. ### Claim 43 (depends on 32) The method of claim 32, wherein the subject exhibits beneficial effects in heart rate and/or rhythm following administration of the composition. ### Claim 44 (depends on 43) The method of claim 43, wherein the beneficial effects include a reduction in arrhythmia suppression levels, ventricular arrhythmia rates, or heart rate or an increase in heart rate variability. ### Claim 45 (depends on 32) The method of claim 32, wherein the composition is administered to the subject in 1 to 4 dosage units per day. ### Claim 46 (depends on 32) The method of claim 32, wherein the eicosapentaenoic acid comprises at least about 96 wt.% of all omega-3 fatty acids in the composition.