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This article summarizes the David Sun Lecture at the American College of Gastroenterology in Orlando, Florida, that was delivered on October 4, 2008. The lecture, entitled "The Future Direction of IBD Care," reviewed the future use of current drugs (such as 5-aminosalicylate, steroids, immunosuppressive medications, and biologic agents) and upcoming drugs in the treatment of IBD.
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Ten patients (9 men, 1 woman; mean [sd]age, 48.1 [12.3] years [range, 23-64 years]) participated in the study. The RAI decreased in all patients. Rifaximin treatment induced clinical remission in 7 patients (70%). No adverse effects were reported.
The majority of patients with UC exhibited low adherence and persistence to mesalamine treatments. Various determinants of improved adherence and persistence were identified.
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Clinical response was highly correlated with 6-TG levels (P < 0.0001) but not with any other variable, including 6-MMP levels, drug dose, gender, and concurrent medications. The frequency of therapeutic response increased at 6-TG levels > 235 pmol/8 x 10(8) erythrocytes (P < 0.001). Hepatotoxicity correlated with elevated 6-MMP levels (>5700 pmol/8 x 10(8) erythrocytes; P < 0.05). Although leukopenia was associated with higher 6-TG levels (P < 0.03), it was observed in only 8% of responders. Patients heterozygous for TPMT (8/92) had higher 6-TG levels (P < 0.0001), and all responded to therapy.
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At 30 mg/day 6-MP, RBC 6-TGN peaked over 4-8 weeks. In the main dosing study, the mean RBC 6-TGN level in patients who remained in remission during the 1-year observation time (n = 151) was 322.3 +/- 119.5 pmole/8 x 10(8) RBC versus 204.8 +/- 78.7 pmole/8 x 10(8) RBC in patients (n = 19) who relapsed (P < 0.001). Bone marrow suppression was seen almost exclusively at high 6-TGN concentration ranges. Further, a regression plot showed an inverse relationship between 6-TGN levels in RBC and TPMT enzyme activity.
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To evaluate the long-term clinical evolution in ulcerative colitis patients responding to a first course of corticosteroids and to identify those factors associated with a poorer outcome.
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Nine RCTs were finally included. With regard to meta-analyses for induction trials, there were no significant differences for all comparisons between the once daily and the divided groups, including maintenance of just clinical remission (P=0.52) and just endoscopic remission (P=0.23), maintenance of combined clinical and endoscopic remission (P=0.78), and the overall incidence of adverse events (P=0.61). With regard to meta-analyses for maintenance trials, there were also no significant differences for all comparisons between once daily and divided groups, including maintenance of just clinical remission (P=0.73) and just endoscopic remission (P=0.43), maintenance of combined clinical and endoscopic remission (P=0.43), the overall incidence of adverse events (P=0.12) as well as compliance with the prescribed medication (P=0.34).
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The response rate was 66% (99 of 149). Fifty-five per cent of the patients felt that they received better medical care than they otherwise would have and 53% liked taking the medication. Sixty-eight per cent of the patients did not feel that annual colonoscopy was too frequent and 81% felt that the time commitment did not significantly interfere with their job or other activities. Seventy-five per cent and 62% of the patients would have liked more information and education, respectively, about Crohn's disease incorporated into the trial. Although 91% of the patients would agree to participate in a future randomized controlled trial comparing medical therapies, only 44% would agree to participate in a future randomized controlled trial comparing medical with surgical therapies.
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Rifaximin plus mesalazine has been showed to be more effective than rifaximin alone in the treatment of recurrent and complicated diverticulitis of the colon. We investigated the effectiveness of the combination rifaximin/mesalazine followed by mesalazine alone to evaluate tolerability and effectiveness in symptomatic remission in uncomplicated diverticular disease.
In the first US randomized placebo-controlled trial of anti-inflammatory treatment after a documented case of diverticulitis, mesalamine demonstrated a consistent trend in reducing symptoms. Addition of probiotic did not increase mesalamine efficacy. This study supports further investigation into the use of anti-inflammatory agents, such as mesalamine, in the long-term management of diverticulitis. ClinicalTrials.gov NCT00554099.
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To conduct a systematic review to evaluate the efficacy of oral 5-ASA agents for the maintenance of medically-induced remission in Crohn's disease.
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The majority of patients were satisfied with their participation in the trial. A large proportion of the patients would participate again but would like more information and education incorporated into the trial. Furthermore, post-trial questionnaires may be helpful in the design of future trials.
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Cochrane Trial Register (until Issue 4, 2008), Medical Literature Analysis and Retrieval System Online (1966 to October 1, 2008), Excerpta Medica Database (1980 to October 1, 2008), and abstracts from the major US, European, and Asian gastroenterology conferences. Expert opinions sought and reference lists of identified studies and any relevant published reviews checked.
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Ninety-eight patients were studied. Forty-two patients (43%) reported taking <80% of their prescribed dose. Logistic regression revealed the independent predictors of non-compliance to be three-times daily dosing [odds ratio (OR), 3.1; 95% confidence interval (CI), 1.8-8.4] and full-time employment (OR, 2.7; 95% CI, 1.1-6.9). Urine from 12 patients (12%) contained no detectable 5-aminosalicylic acid/N-acetyl-5-aminosalicylic acid, and 18 patients (18%) had levels below those expected. Depression was the only independent predictor of complete non-compliance (OR, 10.5; 95% CI, 1.8-79.0), and three-times daily dosing was the only independent predictor of partial non-compliance (OR, 3.7; 95% CI, 1.8-8.9). Self-reporting correctly identified 66% of patients judged to be non-compliant on urinary drug measurement.
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GCAP results were superior to MP for the treatment of UC, even though no statistically significant difference was observed. Side-effects in the GCAP group were significantly lower than in the MP group. This new therapeutic approach seems able to maintain the condition of remission for a longer time after a flare. In fact, the patients who had obtained a remission after a course of CGAP showed fewer relapses during the follow up compared to the patients treated with MP.
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Forty-two patients with severe ulcerative colitis (more than 10 points on the Powell-Tuck scoring system and mucosal disease Heatly grade III or IV).
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Topical therapy with mesalazine and/or corticosteroids is the standard treatment for patients with distal ulcerative colitis. Rectal mesalazine is more effective than rectal systemically active corticosteroids or topically active corticosteroids like budesonide. In patients with mild to moderately active distal ulcerative colitis, topical mesalazine is therefore the treatment of choice. Doses of 1 g or higher are equally effective. The period of treatment is important (4 weeks are more effective than 2 weeks). In the case of nonresponse or nontolerability of rectal mesalazine, rectal budesonide is indicated. The standard dose of budesonide is 2 mg/day. This does not usually induce any corticosteroid-associated adverse events. Treatment with rectal mesalazine plus rectal topically active corticosteroids is even more effective than treatment with either substance alone. To overcome adherence problems with rectal therapy, rectal foam preparations have been developed which are usually better tolerated than enemas.
For patients with UC, NPs are often a primary point of contact, and are therefore ideally placed to take steps to positively influence and change patient behavior.
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We propose that continuous daikenchuto therapy is a clinically useful and feasible maintenance therapy for the prevention of postoperative reoperation in patients with Crohn's disease.
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We retrospectively analyzed clinical courses of 84 patients (43 males, median age 43 years, ranged 20-73 years) diagnosed as UC at Ajou University Hospital between January 1997 and December 2005 based on clinical, endoscopic and pathologic findings, and who were regularly followed for at least one year after the remission.
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Chronisch-entzündliche Darmerkrankungen (CED) zeigen eine Zunahme der Prävalenz in der Schweiz. Industrialisierung und Urbanisierung gehen mit einer Steigerung der Inzidenz einher. CED sind das Resultat eines Kontinuums von Interaktionen zwischen genetischen Faktoren, der intestinalen mikrobiellen Flora, dem Immunsystem sowie von Umgebungs- bzw. Umwelteinflüssen. Für die Therapie beider Erkrankungen wird zwischen Anfallsbehandlung und Remissionserhaltung unterschieden. Beim Morbus Crohn werden bevorzugt systemische Steroide, für die Remissionserhaltung Azathioprin und Methotrexat, neu auch TNFα-Antikörper eingesetzt. Für die Anfallsbehandlung bei der Colitis ulcerosa werden ebenfalls primär systemische Steroide, für die Remissionserhaltung hingegen topisch und systemisch wirksame 5-ASA-Präparate und TNF-Antikörper eingesetzt. Leichtere Fälle können auch in der aktiven Phase mit 5-ASA-Präparaten behandelt werden.
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Patients receiving mesalazine had significantly higher levels of serum free 5-ASA compared to those who were receiving olsalazine and sulphasalazine (mesalazine mean +/- SEM; range; 2.84 +/- 1.21 (0.00-16.00) vs olsalazine 0.45 +/- 0.18 (0.00-16.20); mumol/L; p < 0.04; sulphasalazine 0.37 +/- 0.25 (0.00-3.74); p < 0.03). Similarly levels of urinary free 5-ASA were significantly higher in patients maintained on mesalazine compared to those on olsalazine or sulphasalazine (mesalazine 219 +/- 80.43 (0.00-1050) vs olsalazine 33.3 +/- 17.23 (0.00-317) mumol/L; p < 0.01; and sulphasalazine 15 +/- 8.86 (0.00-192); p < 0.05). However, no significant difference was observed in the levels of urinary free 5-ASA between olsalazine and sulphasalazine. No significant difference was observed in the levels of free-5-ASA in UC patients with left sided disease and those with extensive disease. Furthermore, no significant difference was observed in the levels of serum and urinary 5-ASA in CD patients with ileo-colic disease and colonic disease. Urinary and serum free-5-ASA did not correlate with the clinical disease activity.
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Modified intent-to-treat population (histological evidence of baseline inflammation) had 232, 230 and 210 patients in budesonide MMX 9 mg, budesonide MMX 6 mg and placebo groups respectively. Combined clinical and colonoscopic remission rates were significantly greater than placebo (6.2%) for the budesonide MMX 9 mg group (17.7%; P = 0.0002), but not the budesonide MMX 6 mg group (10.9%). The primary endpoint of remission with budesonide MMX 9 mg was significantly greater than placebo in most subgroups analysed. Symptom resolution and colonoscopic improvement rates were significantly greater with budesonide MMX 9 mg vs. placebo. Budesonide MMX was safe and well tolerated.
The ultrastructure of colonic ICC in the rat model of TNBS-induced colitis showed a severe injury, and administration of SQR or mesalazine reduced the severity of injury. Similarly, the expression of c-kit protein of TNBS-induced colitis rat model was significantly decreased compared with the normal control group (P < 0.05). Treatment with SQR or mesalazine significantly increased the expression of c-kit protein compared with the administration of control formulations (P < 0.05), especially the high-dose SQR group.
The disposition of disodium azodisalicylate and salicylazosulfapyridine was studied in 6 healthy volunteers. After a single oral dose (1.0 g disodium azodisalicylate; 2.3 g salicylazosulfapyridine) maximum serum concentrations of the intact compound ranged between 1.4 and 6.8 mumol/L and 32 and 114 mumol/L, respectively. Mean residence time and serum half-life of disodium azodisalicylate were considerably longer than those of salicylazosulfapyridine, probably because of a higher apparent volume of distribution. Both compounds were largely split by colonic bacteria and comparable amounts of the active moiety, (acetyl-)5-aminosalicylic acid, were recovered in feces. During long-term ingestion of disodium azodisalicylate (1.0 g/day) it took 6-19 days to reach a steady state. Serum concentrations of disodium azodisalicylate at steady state were low: 2.2-8.4 mumol/L. The serum half-life was 6-10 days. It is concluded that the disposition of disodium azodisalicylate is similar, in important respects, to that of salicylazosulfapyridine. Disodium azodisalicylate, therefore, deserves therapeutic trial.
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The efficacy and safety of mesalamine enema were examined in 20 patients with steroid-resistant or dependent, distal ulcerative colitis. Rectal bleeding disappeared in 3 (18%). 8 (50%) of 16 patients within 2 weeks and 4 weeks after the start of mesalamine enema treatment, respectively. Mean clinical activity index (CAI) score after the treatment was significantly reduced (8.1-->3.6, p < 0.001). Furthermore, Mean doses of oral corticosteroid after the treatment (7.3 mg) were also significantly lower than those before the treatment (12.8 mg) (p < 0.01). Four patients dropped out. Three patients could not retain the enemas because of abdominal discomfort and one patient had fever and rash. There were no significant differences in age, gender, disease duration, disease type, and mean doses of oral corticosteroid before the treatment between the response group (n = 8) and the non-response group (n = 8). However, clinical and endoscopic activities before mesalamine enema treatment in the non-response group (CAI 9.8, Matts score 8.0) were higher than those in the response group (CAI 6.4, Matts score 5.5). These results suggest that mesalamine enema is useful for mildly to moderately active distal ulcerative colitis by improving clinical symptoms and reducing corticosteroid.
This prospective study collected data of all patients with ulcerative colitis treated with adalimumab in 10 Hungarian centres. The primary endpoints of the study were rates of remission, response and primary failure at week 12, and the rate of continuous clinical response, remission and loss of response at weeks 30, and 52. Secondary endpoints were endoscopic outcome at week 52 and comparison of the efficacy of adalimumab between treatment naive and infliximab-experienced patients.