{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T18:08:04Z","timestamp":1792692484164,"version":"4.5.0"},"reference-count":62,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T00:00:00Z","timestamp":1761696000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Ulcerative colitis (UC) is a long-term condition marked by recurrent episodes of inflammation affecting the colonic mucosa. Despite mesalamine\u2019s or 5-amino salicylic acid\u2019s (5-ASA) established role in inducing and maintaining remission, some patients experience persistent symptoms and inflammatory activity. Atorvastatin has pleiotropic anti-inflammatory effects, and provide therapeutic benefits in UC. Several preclinical studies assessed the beneficial role of atorvastatin in colitis, but clinical data remain scarce.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of 5-ASA plus atorvastatin (versus 5-ASA plus placebo) in patients with mild to moderate UC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this randomized, double-blind Pilot trial, 54 patients with mild-to-moderate UC were randomized to receive 5-ASA plus atorvastatin (Atorvastatin group, n = 27) or 5-ASA plus placebo (Control group, n = 27) for 6\u00a0months. Clinical activity was assessed using the Simple Clinical Colitis Activity Index (SCCAI), quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ-32), and inflammatory status using serum interleukin-18 (IL-18), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Statistical analysis was conducted using intention to treat.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>After treatment, both groups showed significant changes in all measured parameters when compared to baseline except for bowel frequency at night in control group (p = 0.148). When compared to the control group, the atorvastatin group demonstrated significantly greater post-treatment improvements in IBDQ systemic (p = 0.001), digestive (p = 0.013), emotional domains (p = 0.015), and total score (p = 0.003). Reductions in IL-18, CRP, and ESR were observed in both groups, but were significantly greater with atorvastatin (IL-18: p = 0.026; CRP: p = 0.027; ESR: p = 0.03, SCCAI: p = 0.0005). Clinical response was achieved in 66.6% of atorvastatin-treated patients versus 44% of controls (p = 0.02). Spearman\u2019s analysis showed IBDQ-32 scores were negatively correlated with SCCAI (r = \u22120.498), ESR (r = \u22120.549), CRP (r = \u22120.356), and IL-18 (r = \u22120.548). No significant reported side effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Adjunctive atorvastatin with 5-ASA significantly improved clinical disease activity, quality of life, and inflammatory biomarkers compared to 5-ASA alone in mild-to-moderate patients with UC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>clinicaltrials.gov<\/jats:ext-link>\n                      , Identifier NCT05567068.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2025.1690513","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T06:54:38Z","timestamp":1761720878000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Atorvastatin as an immunomodulatory adjunct in ulcerative colitis, beyond lipid lowering to inflammation control: a randomized controlled pilot study"],"prefix":"10.3389","volume":"16","author":[{"given":"Mohannad O.","family":"Khrieba","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Furqan M.","family":"Abdulelah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nada A.","family":"Alsaleh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hayam Ali","family":"AlRasheed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarek I.","family":"Ahmed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azza","family":"El-Sayed Mansy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manal A.","family":"Hamouda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eslam","family":"Habba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora","family":"Elshorbagi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed G.","family":"Abd Elhameed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eman","family":"Hamza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammed M.","family":"Salahuddin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shereen A.","family":"Mourad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marwa","family":"Kamal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,10,29]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1016\/j.ejphar.2013.08.040","article-title":"Targeting sphingosine kinase 1 (SphK1) and apoptosis by colon-specific delivery formula of resveratrol in treatment of experimental ulcerative colitis in rats","volume":"718","author":"Abdin","year":"2013","journal-title":"Eur. 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