| Title: |
Effect of a high dose atorvastatin as adjuvant therapy to mesalamine in attenuating inflammation and symptoms in patients with ulcerative colitis: a randomized controlled pilot study |
| Authors: |
Sumaiah J. Alarfaj, Sahar M. El-Haggar, Sahar K. Hegazy, Maha M. Maher, Monir M. Bahgat, Thanaa A. Elmasry, Sarah Alrubia, Amsha S. Alsegiani, Mostafa M. Bahaa |
| Source: |
Frontiers in Medicine, Vol 11 (2025) |
| Publisher Information: |
Frontiers Media S.A., 2025. |
| Publication Year: |
2025 |
| Collection: |
LCC:Medicine (General) |
| Subject Terms: |
atorvastatin, calprotectin, oxidative stress, S1P, ulcerative colitis, Medicine (General), R5-920 |
| More Details: |
BackgroundUlcerative colitis (UC) is a chronic inflammatory disorder of the colon. Several preclinical studies investigated the beneficial effects of atorvastatin in colitis. Activation of sphingosine 1 phosphate (S1P)/ tumor necrosis factor-alpha (TNF-α)/ interleukin-6 (IL-6) pathways has been confirmed in the pathogenesis of UC and preclinical studies proved the efficacy of atorvastatin on these pathways.AimTo investigate the role of atorvastatin on S1P/TNF-α/IL-6 pathway in UC.MethodsPatients with mild to moderate UC were allocated into two groups in this pilot study. For 6 months, Group 1 (placebo group) received both a placebo and 1 g of mesalamine three times daily (t.i.d.). Group 2, (the atorvastatin group) received atorvastatin 80 mg once daily and 1 g of mesalamine t.i.d. A gastroenterologist evaluated the patients’ colitis severity by partial Mayo score index (PMS). Serum IL-6, S1P, TNF-α, nitric oxide (NO), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and fecal calprotectin were measured before and after treatment. Short Form 36 questionnaire (SF-36) was also assessed. A clinical response was defined as a decline in the rectal bleeding sub score of at least one point, and a decrease in PMS of at least two points. Clinical remission was defined as a PMS of less than 2 and the absence of any single sub score greater than 1.Primary outcomeDecreased PMS and improved quality of life.Secondary outcomeChange in the level of measured biomarkers.ResultsCompared to the placebo group (n = 24), the atorvastatin group (n = 23) exhibited a significant decrease in the level of IL-6 (p = 0.001), S1P (p = 0.0001), TNF-α (p = 0.003), NO (p = 0.0001), CRP (p = 0.015), ESR (p = 0.012), PMS (p = 0.013), and fecal calprotectin (p = 0.0003), and improved SF-36 (p = 0.006). In placebo group, the response rate was 83.33% (n = 20/24) for PMS, and the remission rate was 45.83% (n = 11/24). In the atorvastatin group, the response rate was 91.3% (n = 21/23), and the remission rate was 60.8% (n = 14/23) for PMS.ConclusionAtorvastatin could be an adjunctive therapy for patients with UC.Clinical trial registrationhttps://www.clinicaltrials.gov/, Identifier NCT05561062. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2296-858X |
| Relation: |
https://www.frontiersin.org/articles/10.3389/fmed.2024.1490178/full; https://doaj.org/toc/2296-858X |
| DOI: |
10.3389/fmed.2024.1490178 |
| Access URL: |
https://doaj.org/article/32ec16f223bb4117854d7a27d192182b |
| Accession Number: |
edsdoj.32ec16f223bb4117854d7a27d192182b |
| Database: |
Directory of Open Access Journals |
