Aim:Maintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2 g/tablet) formulation of 5-aminosalicylic acid. This study evaluated the safety and efficacy of MMX mesalazine dosed once or twice daily as maintenance therapy in patients with ulcerative colitis.Methods:This multicentre, randomised, open-label trial enrolled patients with strictly defined clinical and endoscopic remission, immediately following an episode of mild to moderate ulcerative colitis. Patients were randomised to MMX mesalazine 2.4 g/day as a single (2×1.2 g tablet) or divided dose (1×1.2 g tablet twice daily) for 12 months.Results:174 patients (37.9%; safety population n = 459) experienced 384 adverse events, the majority of which were mild or moderate in intensity. Eighteen patients (3.9%), nine in each group, experienced a total of 22 serious adverse events (10 in the once-daily and 12 in the twice-daily group). Most serious adverse events were gastrointestinal, experienced by 5 patients in the once-daily and 4 in the twice-daily group. At month 12, 64.4% (efficacy population, n = 451) of patients in the once-daily and 68.5% of patients in the twice-daily group were in clinical and endoscopic remission (p = 0.351). At month 12, 88.9% and 93.2% in each group, respectively, had maintained clinical remission (were relapse free).Conclusions:MMX mesalazine 2.4 g/day administered as a single or divided dose demonstrated a good safety profile, was well tolerated and was effective as maintenance treatment. High clinical and endoscopic remission rates can be achieved with once-daily dosing.Trial registration number:NCT00151944.
Forty-two cats underwent craniotomy for removal of a meningioma between 1985 and 1991. Median duration of clinical signs before examination was 1.25 months. All cats had inappropriate demeanor: 48% were dull and 38% were lethargic. Neurological deficits included impaired vision in 93%, paresis in 83%, and seizures in 19%. Computed tomography (CT) showed solitary masses in 86% and multiple masses in 14%. Intraoperative complications included hemorrhage and difficulty excising deep or adherent masses. Anemia in 13 of 42 cats was the most common immediate postoperative complication. Ten of 42 cats had no improvement or a more severe neurological status after surgery. Eight of 42 cats died immediately after surgery; 6 of these were anemic. Of the cats that survived the immediate postoperative period, evaluation 10 to 14 days after surgery showed that 97% (33 of 34) were alert and 79% (27 of 34) had returned to normal behavior. Neurological deficits, except for vision impairment, had resolved in most cats. The duration of follow-up varied from 1.3 months to 55.1 months. Ten cats developed neurological abnormalities from 1 month to 44.2 months after surgery; of these, 6 had tumor recurrence or new growth confirmed by CT scan or necropsy. Overall survival was 71% at 6 months, 66% at 1 year, and 50% at 2 years. Age of cat and location of tumor did not significantly affect survival (P = .1034 and .1851, respectively). There were too few precise measurements of tumor size to make a valid statistical comparison of the effect of size on survival. Location or presence of multiple tumors did not affect final outcome.(ABSTRACT TRUNCATED AT 250 WORDS)
When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets.
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