{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T15:03:12Z","timestamp":1784905392026,"version":"3.55.0"},"reference-count":16,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hemodialysis International"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Uremic pruritus (UP) remains a common and distressing complication in patients with end\u2010stage renal disease (ESRD) receiving maintenance hemodialysis. The burden is particularly pronounced in low\u2010 and middle\u2010income countries where twice\u2010weekly hemodialysis is frequently practiced because of resource limitations. Gabapentin is widely used for the treatment of uremic pruritus; however, its use is often limited by central nervous system adverse effects and poor tolerability in older dialysis populations. Montelukast, a leukotriene receptor antagonist with anti\u2010inflammatory properties, has been proposed as a potential alternative therapy. This study aimed to evaluate the comparative efficacy and safety of montelukast versus gabapentin for the treatment of uremic pruritus in patients receiving twice\u2010weekly hemodialysis, with extended follow\u2010up over 52\u2009weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective, open\u2010label, non\u2010randomized comparative study enrolled 195 adult patients with refractory uremic pruritus receiving twice\u2010weekly hemodialysis. Participants were allocated to receive either montelukast or gabapentin based on predefined clinical and demographic criteria, including physician discretion and patient\u2010specific factors. Clinical follow\u2010up was conducted at 2, 4, 8, 12, 24, and 52\u2009weeks. Pruritus severity was assessed using the Visual Analogue Scale (VAS). The primary outcome was change in Visual Analogue Scale score from baseline. Secondary outcomes included adverse events, treatment tolerability, need for dose escalation, and treatment discontinuation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 176 patients completed the 52\u2010week follow\u2010up (montelukast,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200991; gabapentin,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200985). Baseline pruritus severity was comparable between the montelukast and gabapentin groups (mean VAS score 7.26\u2009\u00b1\u20091.56 vs. 7.41\u2009\u00b1\u20091.67,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.54). Both treatments produced significant reductions in Visual Analogue Scale scores from baseline throughout the 52\u2010week follow\u2010up (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001 for both groups). Dose escalation was required in 38 patients (44.7%) receiving gabapentin within the first 6\u2009weeks of therapy. Adverse events occurred significantly more frequently in the gabapentin group than in the montelukast group; 6 histories of falls and 11 treatment discontinuations due to adverse effects. Frequent adverse events reported in the montelukast group were abdominal pain and headache (17 and 14 episodes, respectively); whereas in the gabapentin group the common side effects were somnolence (39 incidence), fatigue (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200921), dizziness (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200917), and cognitive slowing (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200916). Although gabapentin achieved modestly greater reductions in Visual Analogue Scale scores at selected follow\u2010up time points, the absolute between\u2010group differences remained below the predefined minimum clinically important difference of 1.0 VAS point.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Montelukast provided sustained clinically meaningful improvement in uremic pruritus with substantially fewer treatment\u2010related adverse events and superior tolerability than gabapentin. Although gabapentin achieved slightly greater reductions in pruritus severity at selected time points, these differences did not exceed the predefined minimum clinically important difference of 1.0 VAS point. Montelukast represents a practical and well\u2010tolerated therapeutic option for patients receiving twice\u2010weekly hemodialysis, particularly in resource\u2010limited settings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hdi.70119","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T14:10:04Z","timestamp":1784902204000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Montelukast Versus Gabapentin for Uremic Pruritus in Twice\u2010Weekly Hemodialysis Patients: A 52\u2010Week Prospective Non\u2010Randomized Open\u2010Label Comparative Study"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0264-4777","authenticated-orcid":false,"given":"Bilal","family":"Mohsin","sequence":"first","affiliation":[{"name":"Nephrology Section, Department of Medicine King Faisal Specialist Hospital and Research Center  Jeddah Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4630-569X","authenticated-orcid":false,"given":"Muhammad","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Faisalabad Medical University  Faisalabad Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irfan","family":"Rasool","sequence":"additional","affiliation":[{"name":"Faisalabad Medical University  Faisalabad Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7029-3089","authenticated-orcid":false,"given":"Nouf","family":"Alotaibi","sequence":"additional","affiliation":[{"name":"College of Pharmacy Umm Al\u2010Qura University  Makkah Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7565-5331","authenticated-orcid":false,"given":"Wahaj","family":"Mirajullah","sequence":"additional","affiliation":[{"name":"Nephrology Section, Department of Medicine King Faisal Specialist Hospital and Research Center  Jeddah Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5832-5017","authenticated-orcid":false,"given":"Imran","family":"Khan","sequence":"additional","affiliation":[{"name":"Research Center King Faisal Specialist Hospital and Research Center  Jeddah Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Faisal","sequence":"additional","affiliation":[{"name":"University of Toledo Health Sciences  Toledo Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khalid","family":"Abdulrazek","sequence":"additional","affiliation":[{"name":"Nephrology Section, Department of Medicine King Faisal Specialist Hospital and Research Center  Jeddah Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-3794-8796","authenticated-orcid":false,"given":"Aziz","family":"Mengal","sequence":"additional","affiliation":[{"name":"Department of Family Medicine King Faisal Specialist Hospital and Research Center  Jeddah Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saima","family":"Faisal","sequence":"additional","affiliation":[{"name":"Fatima Jinnah Medical University  Lahore Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,24]]},"reference":[{"issue":"12","key":"e_1_2_12_2_1","doi-asserted-by":"crossref","first-page":"3495","DOI":"10.1093\/ndt\/gfl461","article-title":"Pruritus in Haemodialysis Patients: International Results From the Dialysis Outcomes and Practice Patterns Study (DOPPS)","volume":"21","author":"Pisoni R. L.","year":"2006","journal-title":"Nephrology, Dialysis, Transplantation"},{"issue":"5","key":"e_1_2_12_3_1","first-page":"487","article-title":"Self\u2010Reported Pruritus and Clinical, Dialysis\u2010Related, and Patient\u2010Reported Outcomes in Hemodialysis Patients","volume":"2","author":"Sukul N.","year":"2020","journal-title":"Kidney Medicine"},{"issue":"12","key":"e_1_2_12_4_1","doi-asserted-by":"crossref","first-page":"2000","DOI":"10.2215\/CJN.03280317","article-title":"International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis","volume":"12","author":"Rayner H. C.","year":"2017","journal-title":"Clinical Journal of the American Society of Nephrology"},{"issue":"6","key":"e_1_2_12_5_1","doi-asserted-by":"crossref","first-page":"1151","DOI":"10.1016\/j.jaad.2014.08.004","article-title":"Interleukin\u201031 Is Associated With Uremic Pruritus in Patients Receiving Hemodialysis","volume":"71","author":"Ko M. J.","year":"2014","journal-title":"Journal of the American Academy of Dermatology"},{"issue":"5","key":"e_1_2_12_6_1","doi-asserted-by":"crossref","DOI":"10.3390\/diagnostics12051108","article-title":"Uremic Pruritus: From Diagnosis to Treatment","volume":"12","author":"Cheng A. Y.","year":"2022","journal-title":"Diagnostics"},{"issue":"3","key":"e_1_2_12_7_1","first-page":"378","article-title":"Gabapentin: A Promising Drug for the Treatment of Uremic Pruritus in Hemodialysis Patients","volume":"18","author":"Naini A. E.","year":"2007","journal-title":"Saudi Journal of Kidney Diseases and Transplantation"},{"issue":"2","key":"e_1_2_12_8_1","first-page":"119","article-title":"Uremic Pruritus: Pathophysiology, Clinical Presentation, and Treatments","volume":"41","author":"Ko M. J.","year":"2022","journal-title":"Kidney Research and Clinical Practice"},{"issue":"5","key":"e_1_2_12_9_1","doi-asserted-by":"crossref","first-page":"638","DOI":"10.1053\/j.ajkd.2017.05.018","article-title":"Treatment of Uremic Pruritus: A Systematic Review","volume":"70","author":"Simonsen E.","year":"2017","journal-title":"American Journal of Kidney Diseases"},{"issue":"4","key":"e_1_2_12_10_1","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1111\/ijd.14708","article-title":"Gabapentin for Uremic Pruritus: A Systematic Review of Randomized Controlled Trials","volume":"59","author":"Eusebio\u2010Alpapara K. M. V.","year":"2020","journal-title":"International Journal of Dermatology"},{"key":"e_1_2_12_11_1","first-page":"14","article-title":"Gabapentin for Uremic Pruritus in Hemodialysis Patients: A Qualitative Systematic Review","volume":"3","author":"Lau T.","year":"2016","journal-title":"Canadian Journal of Kidney Health and Disease"},{"issue":"3","key":"e_1_2_12_12_1","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1056\/NEJMoa1912770","article-title":"A Phase 3 Trial of Difelikefalin in Hemodialysis Patients With Pruritus","volume":"382","author":"Fishbane S.","year":"2020","journal-title":"New England Journal of Medicine"},{"issue":"5","key":"e_1_2_12_13_1","doi-asserted-by":"crossref","first-page":"497","DOI":"10.2340\/00015555-1265","article-title":"Visual Analogue Scale: Evaluation of the Instrument for the Assessment of Pruritus","volume":"92","author":"Reich A.","year":"2012","journal-title":"Acta Dermato\u2010Venereologica"},{"issue":"1","key":"e_1_2_12_14_1","first-page":"50","article-title":"Therapeutic Effect of Montelukast for Treatment of Uremic Pruritus in Hemodialysis Patients","volume":"11","author":"Mahmudpour M.","year":"2017","journal-title":"Iranian Journal of Kidney Diseases"},{"issue":"2","key":"e_1_2_12_15_1","first-page":"73","article-title":"Montelukast for Treatment of Refractory Pruritus in Patients on Hemodialysis","volume":"1","author":"Nasrollahi A. R.","year":"2007","journal-title":"Iranian Journal of Kidney Diseases"},{"issue":"2","key":"e_1_2_12_16_1","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.00148-2017","article-title":"Neuropsychiatric Adverse Drug Reactions in Children Initiated on Montelukast in Real\u2010Life Practice","volume":"50","author":"Benard B.","year":"2017","journal-title":"European Respiratory Journal"},{"key":"e_1_2_12_17_1","doi-asserted-by":"crossref","DOI":"10.3389\/fmed.2024.1334944","article-title":"Efficacy and Safety of Systemic Drugs in the Treatment of Uremic Pruritus Among Hemodialysis Patients: A Network Meta\u2010Analysis","volume":"11","author":"Zhao X.","year":"2024","journal-title":"Frontiers in Medicine (Lausanne)"}],"container-title":["Hemodialysis International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hdi.70119","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hdi.70119","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hdi.70119","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T14:10:08Z","timestamp":1784902208000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hdi.70119"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,24]]},"references-count":16,"alternative-id":["10.1111\/hdi.70119"],"URL":"https:\/\/doi.org\/10.1111\/hdi.70119","archive":["Portico"],"relation":{},"ISSN":["1492-7535","1542-4758"],"issn-type":[{"value":"1492-7535","type":"print"},{"value":"1542-4758","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,24]]},"assertion":[{"value":"2026-03-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"hdi.70119"}}