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Comparison of the effect of mesalazine and sulfasalazine on laboratory parameters: a retrospective observational study

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Abstract

Purpose

Mesalazine and sulfasalazine are commonly used drugs for the treatment of inflammatory bowel disease. However, there have been few reports with a strict statistical analysis comparing the effects of mesalazine and sulfasalazine on laboratory test results. Therefore, we designed a retrospective cohort study to investigate whether or not differences in clinical laboratory parameters exist between mesalazine and sulfasalazine users.

Methods

We used data from the Clinical Data Warehouse of Nihon University School of Medicine to identify cohorts of new mesalazine users (n = 303) and sulfasalazine users (n = 67). We used a multivariate regression model and regression adjustment with the propensity score to adjust for differences in baseline covariates between mesalazine and sulfasalazine users, and compared serum levels of creatinine, urea nitrogen, aspartate aminotransferase, alanine aminotransferase, and hematological parameters including red and white blood cell counts and platelet count.

Results

After adjustment, in sulfasalazine users, the mean values for all tests showed no significant change between baseline and during the exposure period. In contrast, in mesalazine users, the mean WBC and platelet counts during the exposure period were significantly lower than those at baseline. Furthermore, mean serum urea nitrogen level during the exposure period was significantly higher than that at baseline. In terms of mean changes in laboratory test values during the exposure period compared with baseline, the reduction of platelet count in mesalazine users was significant in comparison to that in sulfasalazine users.

Conclusion

Our findings suggested that the hematological adverse effects of mesalazine treatment might be greater than those of sulfasalazine treatment.

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References

  1. Rijk MC, van Schaik A, van Tongeren JH (1988) Disposition of 5-aminosalicylic acid by 5-aminosalicylic acid-delivering compounds. Scand J Gastroenterol 23(1):107–111

    Article  PubMed  CAS  Google Scholar 

  2. Sandborn WJ, Hanauer SB (2003) Systematic review: the pharmacokinetic profiles of oral mesalazine formulations and mesalazine pro-drugs used in the management of ulcerative colitis. Aliment Pharmacol Ther 17(1):29–42

    Article  PubMed  CAS  Google Scholar 

  3. Das KM, Eastwood MA, McManus JP, Sircus W (1973) Adverse reactions during salicylazosulfapyridine therapy and the relation with drug metabolism and acetylator phenotype. N Engl J Med 289(10):491–495

    Article  PubMed  CAS  Google Scholar 

  4. Riley SA, Mani V, Goodman MJ, Herd ME, Dutt S, Turnberg LA (1988) Comparison of delayed release 5 aminosalicylic acid (mesalazine) and sulphasalazine in the treatment of mild to moderate ulcerative colitis relapse. Gut 29(5):669–674

    Article  PubMed  CAS  Google Scholar 

  5. Ransford RA, Langman MJ (2002) Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the committee on safety of medicines. Gut 51(4):536–553

    Article  PubMed  CAS  Google Scholar 

  6. Hopkinson ND, Saiz Garcia F, Gumpel JM (1989) Haematological side-effects of sulphasalazine in inflammatory arthritis. Br J Rheumatol 28(5):414–417

    Article  PubMed  CAS  Google Scholar 

  7. Farr M, Tunn EJ, Symmons DP, Scott DG, Bacon PA (1989) Sulphasalazine in rheumatoid arthritis: haematological problems and changes in haematological indices associated with therapy. Br J Rheumatol 28(2):134–138

    Article  PubMed  CAS  Google Scholar 

  8. McKenna KE, Burrows D (1994) Leucopenia, thrombocytopenia and lymphadenopathy associated with sulphasalazine. Clin Exp Dermatol 19(5):419–420

    Article  PubMed  CAS  Google Scholar 

  9. Daneshmend TK (1991) Mesalazine-associated thrombocytopenia. Lancet 337(8752):1297–1298

    Article  PubMed  CAS  Google Scholar 

  10. Casellas F, Vallano A, Malagelada JR (1996) Leukopenia and thrombocytopenia as adverse effects of treatment with 5-aminosalicylic suppositories. J Clin Gastroenterol 22(2):160–161

    Article  PubMed  CAS  Google Scholar 

  11. Farrell RJ, Peppercorn MA, Fine SN, Michetti P (1999) Mesalamine-associated thrombocytopenia. Am J Gastroenterol 94(8):2304–2306

    Article  PubMed  CAS  Google Scholar 

  12. Laidlaw ST, Reilly JT (1994) Antilymphocyte globulin for mesalazine-associated aplastic anaemia. Lancet 343(8903):981–982

    Article  PubMed  CAS  Google Scholar 

  13. Mulder CJ, Tytgat GN, Weterman IT, Dekker W, Blok P, Schrijver M, van der Heide H (1988) Double-blind comparison of slow-release 5-aminosalicylate and sulfasalazine in remission maintenance in ulcerative colitis. Gastroenterology 95(6):1449–1453

    PubMed  CAS  Google Scholar 

  14. Hanauer SB, Verst-Brasch C, Regalli G (1997) Renal safety of long-term mesalamine therapy in inflammatory bowel disease. Gastroenterology 112 [Suppl A]:991

    Google Scholar 

  15. Takahashi Y, Nishida Y, Nakayama T, Asai S (2011) Adverse effect profile of trichlormethiazide: a retrospective observational study. Cardiovasc Diabetol 10:45

    Article  PubMed  CAS  Google Scholar 

  16. Nishida Y, Takahashi Y, Nakayama T, Soma M, Asai S (2011) Comparative effect of olmesartan and candesartan on lipid metabolism and renal function in patients with hypertension: a retrospective observational study. Cardiovasc Diabetol 10:74

    Article  PubMed  CAS  Google Scholar 

  17. Nishida Y, Takahashi Y, Nakayama T, Soma M, Kitamura N, Asai S (2010) Effect of candesartan monotherapy on lipid metabolism in patients with hypertension: a retrospective longitudinal survey using data from electronic medical records. Cardiovasc Diabetol 9:38

    Article  PubMed  Google Scholar 

  18. Kitamura N, Takahashi Y, Yamadate S, Asai S (2007) Angiotensin II receptor blockers decreased blood glucose levels: a longitudinal survey using data from electronic medical records. Cardiovasc Diabetol 6:26

    Article  PubMed  Google Scholar 

  19. Rubin DB (1979) Using multivariate matched sampling and regression adjustment to control bias in observational studies. J Am Stat Assoc 74:318–324

    Google Scholar 

  20. D'Agostino RB Jr (1998) Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 17(19):2265–2281

    Article  PubMed  Google Scholar 

  21. Wu AH, Aaronson KD, Bolling SF, Pagani FD, Welch K, Koelling TM (2005) Impact of mitral valve annuloplasty on mortality risk in patients with mitral regurgitation and left ventricular systolic dysfunction. J Am Coll Cardiol 45(3):381–387

    Article  PubMed  Google Scholar 

  22. Cunliffe RN, Scott BB (2002) Review article: monitoring for drug side-effects in inflammatory bowel disease. Aliment Pharmacol Ther 16(4):647–662

    Article  PubMed  CAS  Google Scholar 

  23. Jick H, Myers MW, Dean AD (1995) The risk of sulfasalazine- and mesalazine-associated blood disorders. Pharmacotherapy 15(2):176–181

    PubMed  CAS  Google Scholar 

  24. Garcia-Diaz M, Nevado L, Berenguer A, Bureo JC, Bureo P, Saenz de Santamaria J (1995) Acute renal failure associated with 5-aminosalicylic acid in inflammatory bowel disease. Gastroenterol Hepatol 18(1):18–21

    PubMed  CAS  Google Scholar 

  25. Hamling J, Raedler A, Helmchen U, Schreiber S (1997) 5-Aminosalicylic acid-associated renal tubular acidosis with decreased renal function in Crohn's disease. Digestion 58(3):304–307

    Article  PubMed  CAS  Google Scholar 

  26. Alivanis P, Aperis G, Lambrianou F, Zervos A, Paliouras C, Karvouniaris N, Arvanitis A (2010) Reversal of refractory sulfasalazine-related renal failure after treatment with corticosteroids. Clin Ther 32(11):1906–1910

    Article  PubMed  CAS  Google Scholar 

  27. Kreisel W, Wolf LM, Grotz W, Grieshaber M (1996) Renal tubular damage: an extraintestinal manifestation of chronic inflammatory bowel disease. Eur J Gastroenterol Hepatol 8(5):461–468

    PubMed  CAS  Google Scholar 

  28. Gran JT, Myklebust G (1993) Toxicity of sulphasalazine in rheumatoid arthritis. Possible protective effect of rheumatoid factors and corticosteroids. Scand J Rheumatol 22(5):229–232

    Article  PubMed  CAS  Google Scholar 

  29. Rogler G (2010) Gastrointestinal and liver adverse effects of drugs used for treating IBD. Best Pract Res Clin Gastroenterol 24(2):157–165

    Article  PubMed  CAS  Google Scholar 

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Correspondence to Yasuo Takahashi.

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Masuda, H., Takahashi, Y., Nishida, Y. et al. Comparison of the effect of mesalazine and sulfasalazine on laboratory parameters: a retrospective observational study. Eur J Clin Pharmacol 68, 1549–1555 (2012). https://doi.org/10.1007/s00228-012-1289-3

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  • DOI: https://doi.org/10.1007/s00228-012-1289-3

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