Method of using L-triiodothyronine (T3) for the treatment of tissue hypoxia and sepsis
View Patent ↗A method of using a composition consisting of L-triiodothyronine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, for the treatment of a patient having an inflammatory response and one or multi-organ dysfunction, including kidney, liver, brain, lung, heart, gastrointestinal hematopoietic, and/or coagulatory system, due to long standing hypoxia and microvascular dysfunction, the patient having sepsis, coronavirus infection, cancer, severe trauma, and/or in heart and/or other organ transplants.
1 . A method of treating an inflammatory response or one or multi-organ dysfunction in a patient with tissue hypoxia and microvascular dysfunction caused by sepsis, severe injury, and/or extracorporeal organ protection, the method comprising: treating the patient's kidneys, liver, brain, heart, gastrointestinal system, haemopoietic system or coagulatory system using a pharmaceutical composition L-triiodothyronine consisting of or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical composition is administered to the patient in a range of 5 to 9 μg L-triiodothyronine or the pharmaceutically acceptable salt thereof per kg of the patient's body weight over a period of 48 hours.
2 . The method according to claim 1 , comprising treating the patient for prolonged hypoxia due to sepsis of at least 30 minutes.
3 . The method according to claim 1 , comprising treating the patient for right ventricular systolic function, wherein a Tricuspid Annular Plane Systolic Excursion (TAPSE) is between 16 and 30 mm.
4 . The method according to claim 1 , comprising treating the patient for right ventricular systolic function, wherein a value of central venous pressure is measured between 1 and 10 mm Hg.
5 . The method according to claim 1 , comprising treating the patient for inflammatory response and coagulatory system dysfunction, wherein a erythrocyte sedimentation rate is reduced by 50% over a period of 48 hours.
6 . The method according to claim 1 , wherein the L-triiodothyronine or the pharmaceutically acceptable salt thereof is formulated either as an injectable solution or as a lyophilized powder for reconstitution.
7 . The method according to claim 6 , wherein the L-triiodothyronine or the pharmaceutically acceptable salt thereof is present in the injectable solution at a concentration from 2 to 20 μg/mL.
8 . The method according to claim 7 , comprising administering the L-triiodothyronine or the pharmaceutically acceptable salt thereof to the patient as a continuous injection at a rate from 0.08 to 0.20 μg/kg/h for 48 hours.
9 . The method according to claim 7 , comprising administering the L-triiodothyronine or the pharmaceutically acceptable salt thereof to the patient as an initial bolus from 0.6 to 1.0 μg L-triiodothyronine per kg of body weight followed by a continuous injection at a rate from 0.10 to 0.20 μg/kg/h for 48 hours.
10 . The method according to claim 7 , comprising administering the L-triiodothyronine or the pharmaceutically acceptable salt thereof to the patient intravenously in a total amount from 375 μg to 675 μg, based on a body weight of the patient of 75 kg.
11 . The method according to claim 1 comprising administering the pharmaceutical composition to the patient in a range of 6 to 8 μg L triiodothyronine or the pharmaceutically acceptable salt thereof per kg of the patient's body weight.
12 . The method according to claim 2 wherein the prolonged hypoxia due to sepsis is for at least 3 hours.
13 . The method according to claim 3 wherein the TAPSE is between 20 and 25 mm.
14 . The method according to claim 4 wherein the central venous pressure is measured between 3.7 and 7.4 mm Hg.
15 . The method according to claim 5 wherein the erythrocyte sedimentation rate is measured below 30 mm within the first hour.
16 . The method according to claim 7 wherein the concentration of the injectable solution is from 5 to 15 μg/mL.
17 . The method according to claim 8 wherein the injection rate is from 0.12 to 0.16 μg/kg/h.
18 . The method according to claim 9 wherein the continuous injection rate is 0.10 to 0.14 μg/kg/h.
19 . The method according to claim 10 wherein the patient receives 450 to 600 μg L triiodothyronine or the pharmaceutically acceptable salt thereof in total.