Preparat: Asacol, Asacol®, Lixacol, Mesasal, Mesavancol, Mezavant, Pentasa, Pentasa Sachet, Salofalk, Salofalk®
ATC kod: A07EC02
Effekten av mesalazin har i en studie visat sig vara bättre hos kvinnor med Crohns sjukdom, medan studier på patienter med ulcerös kolit visar olika resultat vad gäller könsskillnad i effekt.
Studier visar motsägande resultat om det finns en könsskillnad i följsamhet till behandling vid ulcerös kolit eller ej.
Vår bedömning är att de beskrivna skillnaderna inte motiverar olika dosering eller behandling hos kvinnor och män.
Mesalazine is known as mesalamine in English literature . Mesalamine belongs to the 5-ASA group and is used in inflammatory bowel disease.
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 . No other studies with a clinically relevant sex analysis regarding the dosing of mesalamine have been found.
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 .
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 . 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) . The authors suggest that the higher risk of relapse in men might be explained by poor adherence (see Other information).
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 .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
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) . 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 .
Fler män än kvinnor hämtade ut läkemedel innehållande mesalazin (ATC-kod A07EC02) på recept i Sverige år 2015, totalt 15 686 män och 14 631 kvinnor. Det motsvarar 3,2 respektive 3,0 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 25-79 år hos båda könen. I genomsnitt var läkemedel innehållande mesalazin 1,2 gånger vanligare hos män .
Faktagranskat av: Mia von Euler
Godkänt av: Karin Schenck-Gustafsson