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Mesalazine

Classification: A

Drug products: Asacol, Asacol®, Lixacol, Mesasal, Mesavancol, Mezavant, Pentasa, Pentasa Sachet, Salofalk, Salofalk®

ATC code: A07EC02

Substances: mesalazine

Summary

Treatment response to mesalamine has been shown to be better in women with Crohn disease, while studies in ulcerative colitis patients show varying results.

Studies report varying results concerning sex difference in adherence to medications in ulcerative colitis.
 
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.

Additional information

Mesalazine is known as mesalamine in English literature . Mesalamine belongs to the 5-ASA group and is used in inflammatory bowel disease.

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding the pharmacokinetics of mesalamine have been found.One small study (3 men, 5 women) of 60 ml mesalamine found that the local distribution was similar in all patients after anal administration [1]. No other studies with a clinically relevant sex analysis regarding the dosing of mesalamine have been found.

Effects

Response to mesalamine in patients with Crohn disease has retrospectively been assessed in a register-based cohort study (71 men, 94 women). Women were more likely than men to achieve prolonged response or develop mesalamine dependency (68% vs. 51%, odds ratio 2.89). Prolonged response was defined as still in complete/partial response one year after induction of response. Mesalamine dependency was defined as relapse within 1 year after mesalamine discontinuation and regaining complete/partial response after mesalamine re-introduction [2].

In patients with ulcerative colitis, studies of mesalamine efficacy show different results whether treatment success is different in men and women.

A randomized, double-blind, placebo-controlled clinical trial of mesalamine efficacy in patients with ulcerative colitis, showed that patient’s sex did not predict treatment success. Success was defined as maintenance of remission at 6 months, while failure was defined as relapse at any time during the study or withdrawal due to an adverse event [3]. On the other hand, a study of patients with ulcerative colitis treated with mesalamine after a pre- treatment with corticosteroids (19 men, 16 women), showed that the probability of relapse at 1 year was higher in men than in women (hazard ratio 4) [4]. The authors suggest that the higher risk of relapse in men might be explained by poor adherence (see Other information).

Adverse effects

A register-based study has analyzed if long-term use of mesalamine, olsalazine or sulfasalazine reduces the risk of colorectal cancer in patients with inflammatory bowel disease. An increased risk in men was seen among patients who used mesalamine, olsalazine or sulfasalazine for at least 1 year (hazard ratio 1.56). However after at least 5 years the sex difference was only significant for patients with ulcerative colitis (hazard ratio 1.59). After 7.5 years of use, there was no sex difference in risk [5].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

Adherence to medications in patients with ulcerative colitis has varied in men and women in different studies. In one study, where patients received sulfasalazine, mesalamine, olsalazine, or balsalazide (51 men, 43 women), men were twice as likely as women to be non-adherent (odds ratio 2.1) [6]. Contrary to these findings, studies have shown that women with ulcerative colitis were more likely than men to be non-adherent. [7-9]. Furthermore, another study found that patient’s sex did not predict adherence to mesalamine in inflammatory bowel disease [10].

Updated: 2019-02-26

Date of litterature search: 2015-06-30

References

  1. Chapman NJ, Brown ML, Phillips SF, Tremaine WJ, Schroeder KW, Dewanjee MK et al. Distribution of mesalamine enemas in patients with active distal ulcerative colitis. Mayo Clin Proc. 1992;67:245-8. PubMed
  2. Duricova D, Pedersen N, Elkjaer M, Jensen JK, Munkholm P. 5-aminosalicylic acid dependency in Crohn's disease: a Danish Crohn Colitis Database study. J Crohns Colitis. 2010;4:575-81. PubMed
  3. The Mesalamine Study Group. An oral preparation of mesalamine as long-term maintenance therapy for ulcerative colitis A randomized, placebo-controlled trial . Ann Intern Med. 1996;124:204-11. PubMed
  4. Bello C, Belaiche J, Louis E, Reenaers C. Evolution and predictive factors of relapse in ulcerative colitis patients treated with mesalazine after a first course of corticosteroids. J Crohns Colitis. 2011;5:196-202. PubMed
  5. Bernstein CN, Nugent Z, Blanchard JF. 5-aminosalicylate is not chemoprophylactic for colorectal cancer in IBD: a population based study. Am J Gastroenterol. 2011;106:731-6. PubMed
  6. Kane SV, Cohen RD, Aikens JE, Hanauer SB. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001;96:2929-33. PubMed
  7. Yen L, Wu J, Hodgkins PL, Cohen RD, Nichol MB. Medication use patterns and predictors of nonpersistence and nonadherence with oral 5-aminosalicylic acid therapy in patients with ulcerative colitis. J Manag Care Pharm. 2012;18:701-12. PubMed
  8. Kane SV, Accortt NA, Magowan S, Brixner D. Predictors of persistence with 5-aminosalicylic acid therapy for ulcerative colitis. Aliment Pharmacol Ther. 2009;29:855-62. PubMed
  9. Lachaine J, Yen L, Beauchemin C, Hodgkins P. Medication adherence and persistence in the treatment of Canadian ulcerative colitis patients: analyses with the RAMQ database. BMC Gastroenterol. 2013;13:23. PubMed
  10. D'Incà R, Bertomoro P, Mazzocco K, Vettorato MG, Rumiati R, Sturniolo GC. Risk factors for non-adherence to medication in inflammatory bowel disease patients. Aliment Pharmacol Ther. 2008;27:166-72. PubMed
  11. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson