Letter: assessment of safety and efficacy of mesalazine in Indian patients with ulcerative colitis
Year: 2013
Type: letter
Abstract: With reference to the recent article by Flourie et al.,1 we wish to convey our findings on the efficacy, safety and tolerability of mesalazine extended release (MER) in Indian patients with mild-to-moderate ulcerative colitis (UC) assessed through an 8-week, prospective, open label, noncomparative study. Patients (n = 62, men = 47) with UC disease activity index (UCDAI) score ≥3 and ≤8 were administered 2.4 g MER once daily, for 4 weeks initially. At week 4, if the UCDAI score was reduced by ≥2 points from baseline, the same dose was continued for the next 4 weeks. If there was no reduction or a reduction of 1 point in the UCDAI score from baseline, the dose was increased to 4.8g/day once daily for a further 4 weeks. UCDAI score, investigator's global assessment (IGA), patient's global assessment (PGA) of efficacy and adverse events (AE) were the outcomes of interest. There was a significant (P < 0.001) reduction in mean UCDAI score at week 4 compared with baseline, and at week 8 compared with week 4 and baseline (Table 1). Significant (P < 0.001) increases in remission and improvement were observed at week 8 compared with week 4 (Fig 1). Dose up-titration was required in 28 patients. Those who did not require dose up-titration showed a significantly greater reduction (P < 0.001) in UCDAI score. There was a significant agreement (71%, P < 0.001) between IGA and PGA (kappa statistic 0.58). Overall compliance was 96% (standard deviation ± 2.8%) with a significant (P < 0.001) reduction in those receiving a higher dose at week 4. Eleven AEs were reported in 10 patients and one AE was ‘probably’ related to mesalazine. Low haemoglobin [4 (6.5%) patients], which was unlikely to be due to mesalazine, was the most common AE. Mesalazine extended release offered therapeutic benefit with good safety profile to our patients. Declaration of personal interests: Dr Abraham Koshy, Dr Jacob Jayan B, Dr Mohammed Aejaz Habeeb, Dr.NagarjunaYarlagadda, Dr Tantry B Vishwanath and Dr Ubal Dhus are the investigators who conducted this study and do not have any conflict of interest. Dr L. S. Moodahadu is an employee of Sponsor Company and has a stake in terms of salary. Dr B. Krishnankutty, former employee of Dr Reddy's Laboratories Ltd., Hyderabad, India currently does not have any conflict of interest. Declaration of funding interests: This study was sponsored by Dr Reddy's Laboratories Ltd., Hyderabad, India.
DOI: 10.1111/apt.12336
Authors: J. B. Jayan, M. A. Habeeb, V. B. Tantry, N. Yarlagadda, A. Koshy, U. Dhus, B. Krishnankutty, L. S. Moodahadu
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Gastroenterology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2006023434