Data Sheet 1_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.pdf

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.