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
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 conf...
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Frontiers Media S.A.
2025-01-01
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2024.1490178/full |
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| author | Sumaiah J. Alarfaj Sahar M. El-Haggar Sahar K. Hegazy Sahar K. Hegazy Maha M. Maher Maha M. Maher Monir M. Bahgat Thanaa A. Elmasry Sarah Alrubia Amsha S. Alsegiani Mostafa M. Bahaa |
| author_facet | Sumaiah J. Alarfaj Sahar M. El-Haggar Sahar K. Hegazy Sahar K. Hegazy Maha M. Maher Maha M. Maher Monir M. Bahgat Thanaa A. Elmasry Sarah Alrubia Amsha S. Alsegiani Mostafa M. Bahaa |
| author_sort | Sumaiah J. Alarfaj |
| collection | DOAJ |
| description | 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. |
| format | Article |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-32ec16f223bb4117854d7a27d192182b2025-01-22T07:15:49ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-01-011110.3389/fmed.2024.14901781490178Effect of a high dose atorvastatin as adjuvant therapy to mesalamine in attenuating inflammation and symptoms in patients with ulcerative colitis: a randomized controlled pilot studySumaiah J. Alarfaj0Sahar M. El-Haggar1Sahar K. Hegazy2Sahar K. Hegazy3Maha M. Maher4Maha M. Maher5Monir M. Bahgat6Thanaa A. Elmasry7Sarah Alrubia8Amsha S. Alsegiani9Mostafa M. Bahaa10Department of Pharmacy Practice, College of Pharmacy, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi ArabiaClinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Guiesh Street, El-Gharbia Government, Tanta, EgyptClinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Guiesh Street, El-Gharbia Government, Tanta, EgyptPharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, EgyptInternal Medicine Department, Faculty of Medicine, Horus University, New Damietta, EgyptInternal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, EgyptInternal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, EgyptPharmacology and Toxicology Department, Faculty of Pharmacy, Tanta University, Tanta, EgyptPharmaceutical Chemistry Department, College of Pharmacy, King Saud University, Riyadh, Saudi ArabiaPharmaceutical Chemistry Department, College of Pharmacy, King Saud University, Riyadh, Saudi ArabiaPharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, EgyptBackgroundUlcerative 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.https://www.frontiersin.org/articles/10.3389/fmed.2024.1490178/fullatorvastatincalprotectinoxidative stressS1Pulcerative colitis |
| spellingShingle | Sumaiah J. Alarfaj Sahar M. El-Haggar Sahar K. Hegazy Sahar K. Hegazy Maha M. Maher Maha M. Maher Monir M. Bahgat Thanaa A. Elmasry Sarah Alrubia Amsha S. Alsegiani Mostafa M. Bahaa 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 Frontiers in Medicine atorvastatin calprotectin oxidative stress S1P ulcerative colitis |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | atorvastatin calprotectin oxidative stress S1P ulcerative colitis |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2024.1490178/full |
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