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CLINICAL TRIAL article
Front. Med.
Sec. Gastroenterology
Volume 11 - 2024 |
doi: 10.3389/fmed.2024.1490178
This article is part of the Research Topic Recent Advances and New Biomarkers in Ulcerative Colitis - Volume II View all 4 articles
Effect of a High Dose Atorvastatin as Adjuvant Therapy to Mesalamine in Attenuating Inflammation and Symptoms in Patients with Ulcerative Colitis: A Randomized Controlled
Provisionally accepted- 1 Faculty of Pharmacy, Horus University, Damietta, Egypt
- 2 Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia
- 3 Faculty of Pharmacy, Tanta University, Tanta, Gharbia, Egypt
- 4 Faculty of Medicine, Mansoura University, Mansoura, Dakahlia, Egypt
- 5 King Saud University, Riyadh, Riyadh, Saudi Arabia
Background: Ulcerative 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. Aim: To investigate the role of atorvastatin on S1P/TNF-α/IL-6 pathway in UC. Methods: Patients with mild to moderate UC were allocated into two groups in this pilot study. For six 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 outcome: Decreased PMS and improved quality of life. Secondary outcome: Change in the level of measured biomarkers. Results: Compared 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. Conclusion: Atorvastatin could be an adjunctive therapy for patients with UC.
Keywords: atorvastatin, calprotectin, Oxidative Stress, S1P, Ulcerative colitis. Introduction
Received: 02 Sep 2024; Accepted: 04 Dec 2024.
Copyright: © 2024 Bahaa, Alarfaj, El-Haggar, Hegazy, Maher, Bahgat, Elmasry, Alrubia and Alsegiani. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Mostafa Bahaa, Faculty of Pharmacy, Horus University, Damietta, Egypt
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