METHOD OF PROVIDING CELIPROLOL THERAPY TO A PATIENT
The present disclosure relates to the field of treatment of an orphan disease, in particular treatment of vascular Ehlers-Danlos syndrome (vEDS). More specifically, the present disclosure relates to novel up-titration dosage regimens (e.g., escalating dosage regimens) effective for treating vEDS patients with celiprolol.
1 . A method for treating vascular Ehlers-Danlos syndrome, comprising administering to a patient in need thereof a 80 to 100 mg daily dose of celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof, and increasing the daily dose to 360 to 440 mg within six months.
2 . The method of claim 1 , wherein at least a 80 to 100 mg daily dose increase is made within two months.
3 . The method of claim 1 , wherein at least a 170 to 210 mg daily dose increase is made within four months.
4 . The method of claim 1 , wherein at least a 260 to 310 mg daily dose increase is made within six months.
5 . The method of claim 1 , wherein at least a 260 to 310 mg daily dose increase is made within four months.
6 . A method for treating vascular Ehlers-Danlos syndrome, comprising administering to a patient in need thereof an initial daily dose of about 91.25 mg celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof, for about 1 month, followed by administering to the patient a second daily dose of about 182.5 mg celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof, for about 1 month, followed by administering to the patient a third daily dose of about 273.75 mg celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof, for about 1 month, followed by administering to the patient a fourth daily dose of about 365 mg celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof.
7 . The method of claim 6 , wherein the second daily dose is administered twice daily.
8 . The method of claim 7 , wherein the fourth daily dose is administered twice daily.
9 . The method of claim 6 , wherein the fourth daily is administered for at least 1 year.
10 . The method of claim 6 , wherein the fourth daily is administered for at least 5 years.
11 . The method of claim 1 , wherein the patient is 15-years old or older.
12 . The method of claim 1 , wherein the treatment is initiated as soon as vascular EDS is diagnosed, or when the patient is 10 years old.
13 . A method for treating vascular Ehlers-Danlos syndrome, comprising administering to a patient in need thereof a 90 to 110 mg daily dose of celiprolol hydrochloride and increasing the daily dose to 360 to 440 mg within six months.
14 . The method of claim 13 , wherein at least a 90 to 110 mg daily dose increase is made within two months.
15 . The method of claim 13 , wherein at least a 180 to 220 mg daily dose increase is made within four months.
16 . The method of claim 13 , wherein at least a 270 to 330 mg daily dose increase is made within six months.
17 . The method of claim 13 , wherein at least a 270 to 330 mg daily dose increase is made within four months.
18 . A method for treating vascular Ehlers-Danlos syndrome, comprising administering to a patient in need thereof an initial daily dose of about 100 mg celiprolol hydrochloride for about 1 month, followed by administering to the patient a second daily dose of about 200 mg celiprolol hydrochloride for about 1 month, followed by administering to the patient a third daily dose of about 300 mg celiprolol hydrochloride for about 1 month, followed by administering to the patient a fourth daily dose of about 400 mg celiprolol hydrochloride.
19 . The method of claim 18 , wherein the initial daily dose is administered at about 100 mg once daily.
20 . The method of claim 18 , wherein the second daily dose is administered at about 100 mg twice daily.
21 . The method of claim 18 , wherein the fourth daily dose is administered at about 200 mg twice daily.
22 . The method of claim 18 , wherein the fourth daily is administered for at least 1 year.
23 . The method of claim 18 , wherein the fourth daily is administered for at least 5 years.
24 . The method claim 13 , wherein the patient is 15-years old or older.
25 . The method claim 13 , wherein the treatment is initiated as soon as vascular EDS is diagnosed, or when the patient is 10 years old.