ABSTRACT
AIM: To determine in a noninferiority study whether mesalamine foam is as effective as mesalamine liquid enema for inducing clinical remission in patients with active left-sided ulcerative colitis (UC). METHODS: In a multicenter investigator-blind trial, 375 patients with mild-to-moderate UC were randomized to receive mesalamine foam 1 g/80 mL/day or mesalamine liquid enema 1 g/100 mL/day for 4 wk (W). Inclusion criteria were: disease extension at least 5 cm from anorectal junction and not above splenic flexure and Clinical Activity Index (CAI) 1-4 > or = 4. Primary end point was clinical remission at W4 defined as a CAI 1-4 < or = 2. Noninferiority of the foam to liquid enema was declared if the lower limit of the 97.5% unilateral confidence interval (97.5% CI) of the difference in remission rates between foam and liquid enema groups was greater than -15% . RESULTS: Remission rates at W4 in foam versus liquid were 68.3%versus 73.6% in per protocol (PP) population (lower limit of 97.5% CI -15.1%) and 66.7%versus 70.5% in intention-to-treat (ITT) population (97.5% CI -13.4%). Remission rates at W2 were 48.1 %versus 50.6% in ITT (97.5% CI -12.8%) and 49.1%versus 52.1% in PP (97.5% CI -13.8%) in foam versus liquid, respectively. Both treatments were well tolerated. CONCLUSIONS: A 4-wk treatment of 1 g mesalamine foam induced a clinical remission in 68% patients versus 73% with 1 g mesalamine liquid enema. Although the noninferiority of mesalamine foam could not be strictly demonstrated at W4 in the PP analysis, it was achieved in the ITT population and at W2 in both populations. Mesalamine foam represents a therapeutic alternative to mesalamine liquid enema in patients with mild-to-moderate active proctitis and proctosigmoiditis.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Colitis, Ulcerative/drug therapy , Enema/methods , Mesalamine/administration & dosage , Proctitis/drug therapy , Administration, Rectal , Adolescent , Adult , Aged , Aged, 80 and over , Colitis, Ulcerative/complications , Dosage Forms , Female , Humans , Male , Middle Aged , Proctitis/etiology , Proctocolitis/drug therapy , Proctocolitis/etiology , Single-Blind Method , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: EGD can be performed transnasally in adults by using small-diameter endoscopes. A large prospective study was conducted to evaluate the feasibility and tolerance of diagnostic transnasal EGD in daily practice. METHODS: Unsedated transnasal EGD was attempted in 1100 consecutive patients, in 3 different institutions, by using a 5.9-mm or a 5.3-mm diameter endoscope. The operator determined whether the procedure was successful or unsuccessful, the reason for failures, and any side effects. The influence of gender, age, endoscope diameter, and type of topical anesthesia on the success or failure of the procedure was evaluated. Patients who previously had undergone peroral EGD were queried as to which procedure they preferred. RESULTS: Transnasal EGD was feasible in 93.9% of the patients. The causes of failure were as follows: unsuccessful transnasal insertion (62.7%), patient refusal (19.4%), and nasal pain (17.9%). Female gender, young age (< or =35 years), and larger-endoscope diameter were significant predictive factors for procedure failure. Side effects included the following: epistaxis (2.3%), nasal pain (1.6%), and vaso-vagal reaction (0.3%). A majority (91%) of the patients who previously had undergone unsedated peroral EGD with a standard 9.8-mm diameter endoscope preferred transnasal EGD with a small-diameter endoscope. CONCLUSIONS: Transnasal EGD is feasible in daily endoscopic practice and is preferred by patients. Side effects are rare.