Randomized clinical trial: atorvastatin versus placebo in patients with acute exacerbation of mild to moderate ulcerative colitis.
BACKGROUND
Statins are known to possess pleiotropic anti-inflammatory properties which have been evaluated for clinical benefits in a number of disorders. Studies have demonstrated beneficial actions of statins in experimental models of colitis. Clinical evidence in acute exacerbation of ulcerative colitis (UC) is lacking.


OBJECTIVE
This study aims to assess the efficacy and safety of add-on atorvastatin in mild to moderately severe acute exacerbation of UC.


METHODS
Patients with acute exacerbation of UC were randomized to receive either atorvastatin (20 mg) or matching placebo once daily orally for 8 weeks in addition to the standard therapy. Clinical efficacy was assessed by using partial Mayo score (PMS).


RESULTS
Previously diagnosed 64 cases of UC presenting with mild to moderately severe acute exacerbation were randomized to receive either atorvastatin of 20 mg or placebo. Mean PMS increased by 1.5 points and decreased by 0.31 points in atorvastatin and placebo groups, respectively, at 8 weeks compared to the baseline values (p = 0.04). Eight (25 %) and 13 (40.6 %) patients attained the primary outcome criteria for clinical improvement in the atorvastatin and placebo arms, respectively (p = 0.18). Fifteen (46.8 %) patients in the atorvastatin group and no patient in the placebo group had ≥2 point increase in PMS after 8 weeks (p < 0.001).


CONCLUSIONS
Atorvastatin therapy in acute exacerbation of UC may not be associated with beneficial effects. Paradoxical increase in disease activity may be seen in some patients. However, these findings need to be substantiated in larger studies.
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160 012, India.
Puneet
P
Dhamija
Debasish
D
Hota
Rakesh
R
Kochhar
Atul
A
Sachdev
Amitava
A
Chakrabarti
D000208:Acute Disease; D000328:Adult; D000069059:Atorvastatin; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011239:Prednisolone / Q000008:administration & dosage; D011758:Pyrroles / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index
D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D011239:Prednisolone; D000069059:Atorvastatin