RU2022131495A - DOSING SCHEMES FOR THE ADMINISTRATION OF GLUCAGON-LIKE PEPTIDE 2 (GLP-2) ANALOGUES - Google Patents

Claims (27)

1. A method of adjusting the amount of parenteral nutrition (PN) in a human subject receiving glucagon-like peptide 2 (GLP-2) treatment for short bowel syndrome (SBS) in combination with some amount or volume of parenteral nutrition each week, the method comprising: (i) administering to the subject the GLP-2 analog for a period of time sufficient to grow and/or improve the function of the subject's small intestine; (ii) after step (i), reducing the frequency or volume of the parenteral nutrition (PN) regimen in response to improvement in small bowel function; And (iii) optionally repeating steps (i) and (ii) in response to the subject demonstrating an improvement in function over time as a result of additional longitudinal growth of the small intestine; wherein in said method, step (ii) includes the steps of: (a) determining the current volume of PN required by the subject at a given treatment point; (b) measuring the current volume of urine, measuring the current volume of urine produced by the subject, and comparing the current volume of urine with the initial level of urine to determine the absolute increase in daily urine production; And (c) reducing the frequency and/or volume of PN when the subject shows an improvement in small bowel function as indicated by an absolute increase in daily urine production; wherein the new reduced weekly PN volume is equal to the current weekly PN volume minus 7×absolute increase in daily urine volume relative to the initial volume. 2. The method of claim. 1, where the frequency or volume of PP is reduced if the daily volume of urine is at least 10% higher than the initial volume of urine. 3. The method of claim 1 or 2, further comprising the step of determining the current weekly BP volume to use in calculating a new BP volume using said algorithm. 4. The method according to any one of paragraphs. 1-3, wherein GLP-2 therapy comprises administering to a subject a GLP-2 analogue represented by the formula:

Where: R ¹ is hydrogen, C _1-4 alkyl (eg methyl), acetyl, formyl, benzoyl or trifluoroacetyl; X5 is Ser or Thr; X11 is Ala or Ser; R ² is NH ₂ or OH; And Z ¹ and Z ² are independently absent or represent a peptide sequence of 1-6 amino acid units of Lys; or a pharmaceutically acceptable salt or derivative thereof. 5. The method of any one of the preceding claims, wherein the method comprises administering the GLP-2 analog once or twice a week. 6. The method of any one of the preceding claims, wherein the method comprises administering the calculated amount of PN to the subject. 7. A method according to any one of the preceding claims, wherein the method includes the initial step of determining the initial volume and/or determining the subject's daily urine volume. 8. The method of any one of the preceding claims, wherein the method comprises repeating the calculation step using said algorithm at one or more points during a course of GLP-2 therapy received by the subject. 9. The method of any one of the preceding claims, wherein the method comprises determining an initial daily urine volume at the initiation of GLP-2 therapy and calculating a new PN volume within 2, 3, 4, 5, 6, or 7 days after the initiation of GLP-2 therapy. 10. The method of any one of the preceding claims, wherein the method comprises determining an initial daily urine volume at the initiation of GLP-2 therapy and calculating a new PN volume 1, 2, 3, 4, 5, 6, or 7 weeks after the initiation of GLP-2 therapy. 11. The method according to any one of the preceding claims, wherein the risk of side effect of too high PN volume is reduced, the side effect not necessarily being fluid overload.