{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,12]],"date-time":"2024-08-12T14:31:15Z","timestamp":1723473075334},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,8,17]],"date-time":"2021-08-17T00:00:00Z","timestamp":1629158400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Teduglutide is a recombinant analog of human glucagon\u2010like peptide\u20102 that regulates the functional and structural integrity of the cells lining the gastrointestinal tract. Teduglutide is approved for the treatment of patients with short bowel syndrome (SBS) who are dependent on parenteral support (PS). Population pharmacokinetic (PK) and exposure\u2010response analyses were performed to support teduglutide dosing in patients with SBS. The analysis included 219 patients with SBS (aged &lt;1\u00a0year, 5 patients; 1\u201311\u00a0years, 86 patients; 12\u201317\u00a0years, 8 patients; 18\u201379\u00a0years, 120 patients), and 259 non\u2010SBS subjects (including healthy volunteers and subjects with renal or liver impairment). A one\u2010compartment model with first\u2010order absorption and linear elimination adequately characterized the PKs of teduglutide. In patients with SBS, the apparent clearance (CL\/F), volume of distribution (V\/F), and elimination half\u2010life of teduglutide were 16.0\u00a0L\/h, 33.9\u00a0L, and 1.47\u00a0h, respectively. CL\/F depended on body weight and renal function, and V\/F depended on body weight and age. Maximum concentration (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>) of teduglutide was similar in adult and pediatric patients, and in Japanese and non\u2010Japanese patients. A time\u2010 and exposure\u2010response model dependent on the <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> of teduglutide adequately characterized the reduction in PS over more than 2\u00a0years of treatment. Daily dosing of 0.05\u00a0mg\/kg teduglutide resulted in a maximum reduction in PS of 5.76\u00a0L\/week. Higher <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> values were associated with a more important reduction in PS over time. Adult and pediatric patients with SBS presented similar PKs and response to teduglutide.<\/jats:p>","DOI":"10.1111\/cts.13117","type":"journal-article","created":{"date-parts":[[2021,8,17]],"date-time":"2021-08-17T08:46:06Z","timestamp":1629189966000},"page":"2497-2509","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Population pharmacokinetics and exposure\u2010response analyses of teduglutide in adult and pediatric patients with short bowel syndrome"],"prefix":"10.1111","volume":"14","author":[{"given":"Jean\u2010Francois","family":"Marier","sequence":"first","affiliation":[{"name":"Certara Strategic Consulting Princeton New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Jomphe","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting Princeton New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Peyret","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting Princeton New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Wang","sequence":"additional","affiliation":[{"name":"Takeda Lexington Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,8,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-013-0070-y"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0703-7"},{"key":"e_1_2_9_4_1","volume-title":"GATTEX\u00ae (Teduglutide) Prescribing Information","author":"Shire\u2010NPS Pharmaceuticals Inc","year":"2019"},{"key":"e_1_2_9_5_1","volume-title":"Revestive\u00ae (Teduglutide) Summary of Product Characteristics","author":"Shire Pharmaceuticals Ireland Limited","year":"2019"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.09.007"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270009342252"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12161"},{"key":"e_1_2_9_9_1","unstructured":"US Food and Drug Administration.Pharmacokinetics in patients with impaired hepatic function: study design data analysis and impact on dosing and labeling.2003.https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm072123.pdf. 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