{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T10:52:13Z","timestamp":1740135133328,"version":"3.37.3"},"reference-count":9,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,9,5]],"date-time":"2022-09-05T00:00:00Z","timestamp":1662336000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,9,5]],"date-time":"2022-09-05T00:00:00Z","timestamp":1662336000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Norgine Ltd","award":["Original trials"],"award-info":[{"award-number":["Original trials"]}]},{"name":"Norgine Ltd. and Salix Pharmaceuticals","award":["Post hoc analyses"],"award-info":[{"award-number":["Post hoc analyses"]}]},{"name":"Salix Pharmaceuticals","award":["Technical editorial","medical writing assistance"],"award-info":[{"award-number":["Technical editorial","medical writing assistance"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>This analysis characterized changes in sodium levels in patients receiving the 1\u00a0L polyethylene glycol-based preparation NER1006.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Data were pooled from three phase III, randomized clinical trials. A post hoc subanalysis included adults who received a 2-day split-dose (evening\/morning) NER1006 regimen, a 1-day split-dose (morning only) regimen, or evening-before regimen and had an increase in sodium concentrations from normal to above the upper limit of normal (143\u2013148\u00a0mmol\/L) at \u2265\u20091 of three post-treatment visits. Blood samples were collected at baseline, day of colonoscopy (visit 2), 2\u2009\u00b1\u20091\u00a0days post-colonoscopy (visit 3), and 7\u2009\u00b1\u20091\u00a0days post-colonoscopy (visit 4).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 214 of 1028 patients were included. Of the 214 patients, sodium concentration increased from a mean baseline value of 141.8\u00a0mmol\/L to a mean of 147.1\u00a0mmol\/L (median increase from baseline of approximately 5\u00a0mmol\/L). The mean sodium concentration was within normal range at visit 3 (142.3\u00a0mmol\/L) and visit 4 (142.4\u00a0mmol\/L), as was the median sodium concentration. Overall, ~\u200990% of patients had a normal serum concentration at visits 3 and 4. Based on day of colonoscopy test results, there were four adverse events involving hypernatremia (0.4% of 1028), which were mild and did not require medical intervention; sodium levels returned to normal range by visit 3.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>NER1006 was associated with small, transient increases in sodium levels that were not considered clinically significant.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> NOCT (ClinicalTrials.gov: NCT02254486 [registered October 2, 2014]), MORA (ClinTrials.gov: NCT02273167 [registered October 23, 2014]; EudraCT number: 2014-002185-78 [registered August 13, 2014]), DAYB (ClinicalTrials.gov: NCT02273141 [registered October 23, 2014]; EudraCT Number: 2014-002186-30 [registered August 12, 2014])<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12876-022-02484-7","type":"journal-article","created":{"date-parts":[[2022,9,5]],"date-time":"2022-09-05T20:37:13Z","timestamp":1662410233000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials"],"prefix":"10.1186","volume":"22","clinical-trial-number":[{"clinical-trial-number":"nct02254486","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02273167","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02273141","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8497-3349","authenticated-orcid":false,"given":"Brooks D.","family":"Cash","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Allen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David M.","family":"Poppers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,9,5]]},"reference":[{"issue":"9","key":"2484_CR1","first-page":"1008","volume":"84","author":"JA DiPalma","year":"1989","unstructured":"DiPalma JA, Brady CE III. Colon cleansing for diagnostic and surgical procedures: polyethylene glycol-electrolyte lavage solution. Am J Gastroenterol. 1989;84(9):1008\u201316.","journal-title":"Am J Gastroenterol"},{"issue":"5 Pt 1","key":"2484_CR2","doi-asserted-by":"publisher","first-page":"991","DOI":"10.1016\/0016-5085(80)90781-7","volume":"78","author":"GR Davis","year":"1980","unstructured":"Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980;78(5 Pt 1):991\u20135.","journal-title":"Gastroenterology"},{"key":"2484_CR3","doi-asserted-by":"crossref","unstructured":"Bisschops R, Manning J, Clayton LB, Ng Kwet Shing R, \u00c1lvarez-Gonz\u00e1lez M, MORA Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019;51(1):60\u201372.","DOI":"10.1055\/a-0638-8125"},{"issue":"3","key":"2484_CR4","doi-asserted-by":"publisher","first-page":"677","DOI":"10.1016\/j.gie.2017.07.047","volume":"87","author":"MP DeMicco","year":"2018","unstructured":"DeMicco MP, Clayton LB, Pilot J, Epstein MS, NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018;87(3):677\u201387.","journal-title":"Gastrointest Endosc"},{"issue":"1","key":"2484_CR5","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1055\/a-0639-5070","volume":"51","author":"S Schreiber","year":"2019","unstructured":"Schreiber S, Baumgart DC, Drenth JPH, Filip RS, Clayton LB, Hylands K, et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy. 2019;51(1):73\u201384.","journal-title":"Endoscopy"},{"issue":"12","key":"2484_CR6","doi-asserted-by":"publisher","first-page":"1671","DOI":"10.1016\/j.dld.2019.06.026","volume":"51","author":"A Repici","year":"2019","unstructured":"Repici A, Coron E, Sharma P, Spada C, Di Leo M, Noble CL, et al. Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution. Dig Liver Dis. 2019;51(12):1671\u20137.","journal-title":"Dig Liver Dis"},{"issue":"3","key":"2484_CR7","doi-asserted-by":"publisher","first-page":"656","DOI":"10.1016\/j.gie.2018.11.009","volume":"89","author":"DK Rex","year":"2019","unstructured":"Rex DK. Hyperosmotic low-volume bowel preparations: is NER1006 safe? Gastrointest Endosc. 2019;89(3):656\u20138.","journal-title":"Gastrointest Endosc"},{"issue":"4","key":"2484_CR8","doi-asserted-by":"publisher","first-page":"908","DOI":"10.1016\/j.gie.2019.02.004","volume":"89","author":"A Repici","year":"2019","unstructured":"Repici A, Hassan C, Hoorn EJ, Bisschops R. NER1006 is clinically safe. Gastrointest Endosc. 2019;89(4):908\u20139.","journal-title":"Gastrointest Endosc"},{"key":"2484_CR9","unstructured":"Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution). Package insert. Bridgewater: Salix Pharmaceuticals; 2021."}],"container-title":["BMC Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02484-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12876-022-02484-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02484-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,5]],"date-time":"2022-09-05T20:39:33Z","timestamp":1662410373000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcgastroenterol.biomedcentral.com\/articles\/10.1186\/s12876-022-02484-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,5]]},"references-count":9,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["2484"],"URL":"https:\/\/doi.org\/10.1186\/s12876-022-02484-7","relation":{},"ISSN":["1471-230X"],"issn-type":[{"type":"electronic","value":"1471-230X"}],"subject":[],"published":{"date-parts":[[2022,9,5]]},"assertion":[{"value":"15 November 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 August 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 September 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All three previously published trials received Institutional Review Board (IRB) approval from a centralized IRB (Quorum Review IRB, Seattle, WA [NOCT]) or the IRB of each study center (MORA, DAYB) and were conducted in accordance with International Conference on Harmonisation Guidelines for Good Clinical Practice and ethical principles of the Declaration of Helsinki. All patients provided written informed consent for participation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"BDC reports serving as a consultant and speaker for Salix Pharmaceuticals. CA is an employee of Salix Pharmaceuticals. DMP reports serving as a consultant and educator for Olympus Medical; and serving as a consultant for Salix Pharmaceuticals.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"412"}}