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Immunomodulating Agents in Gastrointestinal Disease
Published in Thomas F. Kresina, Immune Modulating Agents, 2020
Samir A. Shah, Athos Bousvaros, A. Christopher Stevens
Oral 5-ASA compounds, including olsalazine (Dipentum) and mesalamine (Pentasa and Asacol), are effective in inducing remissions in active ulcerative colitis (UC), with a response ranging from 50% to 71 % at dosages of 2 to 3 g for olsalazine, 2.4 to 4.8 g for Asacol, and 2 to 4 g for Pentasa [50–55]. Topical therapy with 5-ASA enemas is also beneficial in both active distal disease, with remission rates as high as 93% (4 g/day) for active disease and 75% for maintenance of remission [56,57].
Compatibility of commonly used drugs in lactation
Published in Amy Brown, Wendy Jones, A Guide to Supporting Breastfeeding for the Medical Profession, 2019
Sulfasalazine – be alert for bloody diarrhoea. RID 0.3–1.1%; licensed for use in children > 2 years. Mesalazine – be alert for watery diarrhoea. Negligible amounts in milk. RID 0.12–8.76%.Balsalazide – absorbed in colon, not gut, and broken down to mesalazine. No studies located. Be alert for watery diarrhoea.Olsalazine – one case study of 1 patient where RID calculated as 0.9%. Monitor for watery diarrhoea.
Adverse effects of drugs on the gastrointestinal tract
Published in Michael JG Farthing, Anne B Ballinger, Drug Therapy for Gastrointestinal and Liver Diseases, 2019
Mefanamic acid, often used in treating menstrual pain, can occasionally cause diarrhoea. Symptoms may appear malabsorptive or colitic and reverse on stopping the drug. The mechanism is unclear but since mefanamic acid is NSAID-like it would be expected that constipation would occur rather than diarrhoea. 5-aminosalicylate, although used to treat inflammatory bowel disease is an occasional cause of diarrhoea, and exacerbation of diarrhoea during its use may indicate drug toxicity rather than an exacerbation of inflammation. Olsalazine, which has two 5-aminosalicylate molecules linked through a diazobond, is particularly likely to cause diarrhoea. The symptom may be secretory in origin.
Classification and clinical features of adverse drug reactions in patients with ulcerative colitis treated with 5‐aminosalicylate acid: a single-center, observational study
Published in Scandinavian Journal of Gastroenterology, 2022
Yuri Tsujii, Tsutomu Nishida, Naoto Osugi, Yoshifumi Fujii, Aya Sugimoto, Dai Nakamatsu, Kaori Mukai, Kengo Matsumoto, Shiro Hayashi, Masashi Yamamoto, Sachiko Nakajima
We found a frequency of 12.9% for 5-ASA-related ADRs of any grade in patients with UC. A systematic review with 23 randomized, double-blind clinical trials of 5-ASA formulation treatment for inducing remission of active UC showed that the frequencies of AEs and study withdrawals due to AEs for patients with active UC were 5–96% and 0–28%, respectively. AEs can include events that result from the therapy being given or from something other than the drug. Therefore, even though AEs in the placebo group were observed in 5–93% of patients in this review, the rates of withdrawal of 5-ASA due to AEs ranged from 2% to 19%, except for one high rate for olsalazine (28%) [1]. The ADR rate in this study seemed to correspond to the frequency of the study withdrawal rate due to AEs without olsalazine. In this systematic review, however, most studies did not specify the severity of AEs, the definitions of serious or severe events appeared to vary, and the frequency of individual AEs in the clinical trials was not uniformly available [1]. In this study in Japanese patients with UC, we revealed that 37% of ADRs were severe (grade 3/4), their triggers were not always the first use of 5-ASA, and 37% of ADRs were due to 5-ASA switch or dose escalation. Approximately half of the cases with ADRs were not severe. Approximately 60% of cases were able to reintroduce 5-ASA by switching or dose reduction after another 5-ASA switch. In addition, one patient complained after long-term use of ASA for approximately 2 years. 5-ASA-related ADRs occur regularly and seem to be underestimated in the real world.
Complications and adverse effects related to surgical and medical treatment in patients with inflammatory bowel disease in a prospectively recruited population-based cohort
Published in Scandinavian Journal of Gastroenterology, 2021
Anders Rönnblom, Östen Ljunggren, Urban Karlbom
In this population-based cohort of IBD patients, we have studied the occurrence of treatment adverse effects with respect to both pharmacological and surgical therapy. We have found adverse effects associated with pharmacological therapy in a range that for the individual drugs has been reported earlier [6,32]. The most frequently used drugs, the salicylates including mesalamine, olsalazine and balsalazide were associated with side effects/complications leading to withdrawal in 5.5–7.9% of patients with UC and CD, respectively. The corresponding figure for the original SASP is 4-fold higher, thereby reaching the same level as for the IMM, a consequence of the sulphapyridin moiety. We could observe that younger patients seem to tolerate SASP and IMM better than older, an observation that regarding IMM has been reported before [15]. Pulmonary side effects of mesalamine are well known in the literature [33,34], but are considered to be very rare. The individuals affected among our patients had their symptoms between one and three months before suspicion of adverse event aroused, and all recovered promptly after cessation of the drug.
Efficacy and safety of oral Pentasa (prolonged-release mesalazine) in mild-to-moderate ulcerative colitis: a systematic review and meta-analysis
Published in Current Medical Research and Opinion, 2021
Kristine Paridaens, John R. Fullarton, Simon P. L. Travis
In comparison to other 5-ASAs, Pentasa was found to be similarly effective as Eudragit-S, Eudragit-L, and MMX mesalazines for the induction of (clinical/composite) remission at lower (2.25–3 vs 2.4–3 g/day, respectively) and higher doses (4 vs 4.8 g/day) (Figure 4). Similarly, Pentasa (1.5–2.25 g/day) was found to be comparable to Eudragit-S mesalazine (1.2–2.4 g/day) and sulfasalazine (3 g/day) as maintenance treatment using data only from RCTs (Figure 5). Treatment-related AE rates for Pentasa and Eudragit-L/Eudragit-S mesalazines were similar, whilst significantly (p < .05) better tolerability was seen for Pentasa against sulfasalazine (Figure 6). These results are consistent with previous observations, such as those from the Cochrane Collaboration17,18, and reflect major international guidelines on the management of UC, which recommend 5-ASAs as first-line therapy for mild-to-moderate UC and do not distinguish between the formulations in terms of efficacy, but where treatment with sulfasalazine (and olsalazine) are not considered preferable due to the high frequency of AEs5,6,40,41. Sulfasalazine is a prodrug consisting of azo-bonded mesalazine and sulfapyridine molecules, with systemic absorption of the latter contributing to the higher rate of AEs reported versus coated mesalazine formulations, such as Pentasa8.