{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T03:57:41Z","timestamp":1791863861976,"version":"4.3.4"},"reference-count":31,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T00:00:00Z","timestamp":1685577600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T00:00:00Z","timestamp":1685577600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Palliative Medicine"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The opioid analgesic hydromorphone has a low renal excretion ratio; however, exposure after oral administration is several times higher in those with moderate or severe renal impairment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>We evaluated the impact of renal impairment on the steady-state pharmacokinetics of intravenously administered hydromorphone in patients with cancer being treated for pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This was an open-label, prospective, parallel-comparison, interventional clinical pharmacology study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting\/Subjects:<\/jats:title>\n                    <jats:p>This study was conducted at one hospital in Japan. Using creatinine clearance (CLcr) values, patients were grouped according to kidney function: CLcr \u226590\u2009mL\/min (normal), 60\u2013&lt;90\u2009mL\/min (mild impairment), 30\u2013&lt;60\u2009mL\/min (moderate impairment), or &lt;30\u2009mL\/min (severe impairment).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements:<\/jats:title>\n                    <jats:p>Hydromorphone was administered by constant infusion to patients at the same constant dose rate as at the time of enrollment. Hydromorphone and its glucuronide metabolite concentrations in plasma and urine were measured by liquid chromatography-mass spectrometry. Pharmacokinetic parameters at steady state were assessed using noncompartmental analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Thirty-two patients were enrolled (normal,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u20093; mild,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200910; moderate,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200915; and severe,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u20094). Adjusted geometric mean ratios for hydromorphone steady-state clearance (CLss) for patients with impaired versus normal renal function were 0.69 (90% confidence interval [CI], 0.41\u20131.14), 0.52 (90% CI, 0.31\u20130.84), and 0.55 (90% CI, 0.30\u20131.02) for mild, moderate, or severe impairment, respectively. Exposures to the metabolite hydromorphone-3-glucuronide generally increased with renal impairment. No adverse event was reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Hydromorphone CLss in patients with impaired renal function (moderate and severe) was decreased \u223c50% of that of normal renal function.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jpm.2022.0289","type":"journal-article","created":{"date-parts":[[2022,12,29]],"date-time":"2022-12-29T09:07:55Z","timestamp":1672304875000},"page":"768-775","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Steady-State Pharmacokinetics of Intravenous Hydromorphone in Japanese Patients With Renal Impairment and Cancer Pain"],"prefix":"10.1177","volume":"26","author":[{"given":"Toshihiko","family":"Nakatani","sequence":"first","affiliation":[{"name":"Department of Palliative Care, Shimane University Faculty of Medicine, Izumo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhito","family":"Shiosakai","sequence":"additional","affiliation":[{"name":"Data Intelligence Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Palliative Care Center, Shimane University Hospital, Izumo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masao","family":"Shionoya","sequence":"additional","affiliation":[{"name":"Statistical Analysis Department, Mebix, Inc., Tokyo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takaaki","family":"Akasaka","sequence":"additional","affiliation":[{"name":"Primary Medical Science Department, and Daiichi Sankyo Co., Ltd., Tokyo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaoru","family":"Toyama","sequence":"additional","affiliation":[{"name":"Quantitative Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitoshi","family":"Ishizuka","sequence":"additional","affiliation":[{"name":"Quantitative Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoji","family":"Saito","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Shimane University Faculty of Medicine, Izumo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,6,2]]},"reference":[{"key":"e_1_3_7_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2009.12.023"},{"key":"e_1_3_7_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2006.10.015"},{"key":"e_1_3_7_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2015.12.340"},{"key":"e_1_3_7_5_2","unstructured":"World Health Organization. Cancer pain relief: With a guide to opioid availability 2nd ed. 1996. Available from: https:\/\/apps.who.int\/iris\/handle\/10665\/37896 [Last accessed: May 12 2022]."},{"key":"e_1_3_7_6_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.ajp.0000210925.33783.4d"},{"key":"e_1_3_7_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0885-3924(02)00390-1"},{"key":"e_1_3_7_8_2","doi-asserted-by":"publisher","DOI":"10.1177\/147323000803600218"},{"key":"e_1_3_7_9_2","doi-asserted-by":"publisher","DOI":"10.1054\/bjoc.2001.1680"},{"key":"e_1_3_7_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(12)70040-2"},{"key":"e_1_3_7_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy152"},{"key":"e_1_3_7_12_2","unstructured":"National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice in Oncology: Adult cancer pain Version 1.2018 2018. Available from: https:\/\/oncolife.com.ua\/doc\/nccn\/Adult_Cancer_Pain.pdf [Last accessed: May 12 2022]."},{"key":"e_1_3_7_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1533-2500.2008.00204.x"},{"key":"e_1_3_7_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2004.02.021"},{"key":"e_1_3_7_15_2","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S262843"},{"key":"e_1_3_7_16_2","unstructured":"Dilaudid\u00ae and Dilaudid-HP\u00ae injection 1\u2009mg\/mL 2\u2009mg\/mL 4mg\/mL and 10\u2009mg\/mL (hydromorphone hydrochloride) C-II 2009. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2009\/019034s018lbl.pdf [Last accessed: May 12 2022]."},{"key":"e_1_3_7_17_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.501"},{"key":"e_1_3_7_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/jat\/bkw085"},{"key":"e_1_3_7_19_2","first-page":"81","article-title":"Pharmacokinetics of oral immediate-release hydromorphone (Dilaudid IR) in subjects with renal impairment","volume":"44","author":"Durnin C","year":"2001","unstructured":"Durnin C, , Hind I, , Wickens M, et al. Pharmacokinetics of oral immediate-release hydromorphone (Dilaudid IR) in subjects with renal impairment. Proc West Pharmacol Soc, 2001; 44:81\u201382.","journal-title":"Proc West Pharmacol Soc"},{"key":"e_1_3_7_20_2","unstructured":"Dilaudid\u00ae prescribing information 2021. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/019891s029 019892s037lbl.pdf [Last accessed: May 12 2022]."},{"key":"e_1_3_7_21_2","unstructured":"Naruvein Injection Package Insert 2021 (In Japanese). Available from: https:\/\/www.info.pmda.go.jp\/go\/pack\/8119401A1020_1_06\/?view=frame&style=XML&lang=ja [Last accessed: May 12 2022]."},{"key":"e_1_3_7_22_2","unstructured":"Hydromorphone Hydrocholoride injection Package Insert 2019. Available from: http:\/\/labeling.pfizer.com\/ShowLabeling.aspx?id=14580#S12.3 [Last accessed: May 12 2022]."},{"key":"e_1_3_7_23_2","unstructured":"Center for Drug Evaluation and Research Food and Drug Administration. Pharmacokinetics in patients with impaired renal function\u2014study design data analysis and impact on dosing and labeling 2020. Available from: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/pharmacokinetics-patients-impaired-renal-function-study-design-data-analysis-and-impact-dosing-and [Last accessed: May 12 2022]."},{"key":"e_1_3_7_24_2","unstructured":"European Medicines Agency. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function 2015. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-evaluation-pharmacokinetics-medicinal-products-patients-decreased-renal-function_en.pdf [Last accessed: May 12 2022]."},{"key":"e_1_3_7_25_2","unstructured":"Common technical document for NARUVEIN INJECTION 2\u2009mg and 20\u2009mg (In Japanese). Available from: https:\/\/www.pmda.go.jp\/drugs\/2018\/P20180206001\/index.html [Last accessed: May 12 2022]."},{"key":"e_1_3_7_26_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.305"},{"key":"e_1_3_7_27_2","doi-asserted-by":"publisher","DOI":"10.1097\/00008571-200011000-00002"},{"key":"e_1_3_7_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/0885-3924(94)00121-Z"},{"key":"e_1_3_7_29_2","doi-asserted-by":"publisher","DOI":"10.3390\/toxins10050202"},{"key":"e_1_3_7_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbadis.2012.09.006"},{"key":"e_1_3_7_31_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0025-6196(11)60750-7"},{"key":"e_1_3_7_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0024-3205(01)01133-X"}],"container-title":["Journal of Palliative Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/jpm.2022.0289","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jpm.2022.0289","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jpm.2022.0289","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T17:16:21Z","timestamp":1777655781000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/jpm.2022.0289"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6]]},"references-count":31,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,6]]}},"alternative-id":["10.1089\/jpm.2022.0289"],"URL":"https:\/\/doi.org\/10.1089\/jpm.2022.0289","relation":{},"ISSN":["1096-6218","1557-7740"],"issn-type":[{"value":"1096-6218","type":"print"},{"value":"1557-7740","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6]]}}}