Methods of reducing the likelihood of carcinoid heart disease in patients with neuroendocrine tumors
AssigneeTerSera Therapeutics LLC
InventorsLonnie Brent, Janine North
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Abstract
Described herein are methods of treating a human patient with a newly diagnosed neuroendocrine tumor, methods of treating patients with neuroendocrine tumors with early signs of carcinoid heart disease who have not had a heart valve replacement, and methods of treating a human patient with the neuroendocrine tumor who has had a recent heart valve replacement. Administering telotristat ethyl to these patients can reduce the development of carcinoid heart disease and improve clinical outcomes.
Claims8
A method of treating or managing a human patient with a newly diagnosed neuroendocrine tumor, wherein the human patient with the newly diagnosed neuroendocrine tumor has not been diagnosed with carcinoid syndrome or carcinoid heart disease, comprising
- at least quarterly, after newly diagnosing the neuroendocrine tumor, measuring a level of 5-hydroxyindoleacetic acid (5-HIAA) in a plasma or urine sample from the patient, and
- daily administering a therapeutically effective amount of telotristat ethyl or a pharmaceutically acceptable salt thereof to a patient having an initial level of 5-HIAA at least two times greater than the upper limit of normal (ULN), wherein the initial level of 5-HIAA is a level prior to administration of telotristat ethyl,
- wherein the ULN is about 22 ng/ml for the plasma sample or 8 mg/24 hours for the urine sample, and
- wherein administering telotristat ethyl or the pharmaceutically acceptable salt thereof to the patient delays or reduces the likelihood of the development of carcinoid heart disease in the patient.
Dependencies are inferred from the claim text.