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Randomized clinical trial: Atorvastatin versus placebo in patients with acute exacerbation of mild to moderate ulcerative colitis

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Abstract

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.

Aim

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).

Conclusion

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.

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Acknowledgments

The authors sincerely acknowledge the contribution by Prof V R Sinha, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India, for his help in the study conduct and Dr Reddy’s Laboratory, Hyderabad, India, for providing the study drugs.

Conflict of interest

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare no support from any organization for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work.

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Authors and Affiliations

  1. Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160 012, India

    Puneet Dhamija, Debasish Hota & Amitava Chakrabarti

  2. Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160 012, India

    Rakesh Kochhar

  3. Department of Internal Medicine, Government Medical College and Hospital, Chandigarh, 160 030, India

    Atul Sachdev

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  1. Puneet Dhamija
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  2. Debasish Hota
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Correspondence to Debasish Hota.

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Dhamija, P., Hota, D., Kochhar, R. et al. Randomized clinical trial: Atorvastatin versus placebo in patients with acute exacerbation of mild to moderate ulcerative colitis. Indian J Gastroenterol 33, 151–156 (2014). https://doi.org/10.1007/s12664-013-0420-4

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  • DOI: https://doi.org/10.1007/s12664-013-0420-4

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