Bristol, CT, United States
Bristol, CT, United States

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Lichtenstein G.R.,University of Pennsylvania | Zakko S.,Connecticut Gastroenterology Institute | Gordon G.L.,Center for Digestive and Liver Diseases | Murthy U.,Syracuse Medical Center | And 5 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2012

Background Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials. Aim To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations. Methods Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation. The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment. Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare. Results Of the 487 patients who received 5-ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group. The percentage of patients who remained relapse-free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P < 0.001). Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint). Conclusion Mesalazine granules 1.5 g once-daily is effective for maintenance of remission in UC patients who switch from other 5-ASA formulations. identifiers NCT00744016, NCT00767728. © 2012 Blackwell Publishing Ltd.


Sandborn W.J.,University of California at San Diego | Bosworth B.,New York Presbyterian Hospital | Zakko S.,Connecticut Gastroenterology Institute | Gordon G.L.,Center for Digestive and Liver Diseases Inc. | And 8 more authors.
Gastroenterology | Year: 2015

Background Aims Budesonide is a high-potency, second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids. We performed 2 randomized, phase 3 trials to evaluate the ability of budesonide rectal foam, formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon, to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis. Methods Two identically designed, randomized, double-blind, placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo. Results Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo (Study 1: 38.3% vs 25.8%; P =.0324; Study 2: 44.0% vs 22.4%; P <.0001). A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution (Study 1: 46.6% vs 28.0%; P =.0022; Study 2: 50.0% vs 28.6%; P =.0002) and endoscopic improvement (Study 1: 55.6% vs 43.2%; P =.0486; Study 2: 56.0% vs 36.7%; P =.0013) at week 6. Most adverse events occurred at similar frequencies between groups, although events related to changes in cortisol values were reported more frequently with budesonide foam. There were no cases of clinically symptomatic adrenal insufficiency. Conclusions Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. © 2015 by the AGA Institute.


Gordon G.L.,Center for Digestive and Liver Diseases Inc. | Zakko S.,Connecticut Gastroenterology Institute | Murthy U.,Syracuse Medical Center | Sedghi S.,Gastroenterology Assoct. of Central Georgia LLC | And 6 more authors.
Journal of Clinical Gastroenterology | Year: 2016

Goals: To evaluate the efficacy and safety of mesalamine granules 1.5 g once daily for maintenance of ulcerative colitis : A Randomized, Placebo-controlled Clinical Trial(UC) remission. Background: Mesalamine is a first-line treatment for induction and maintenance of UC remission. Study: A phase 3, randomized, double-blind, placebo-controlled trial of patients with a history of mild to moderate UC, currently in remission, who received mesalamine granules once daily for 6 months. The primary efficacy endpoint was percentage of patients maintaining UC remission at 6 months. Results: A significantly greater percentage of patients receiving mesalamine granules versus placebo were in remission at 6 months (79.9% vs. 66.7%; P=0.03). A greater percentage of patients receiving mesalamine granules maintained a revised Sutherland Disease Activity Index (SDAI)≤2 with no individual component of revised SDAI>1 and rectal bleeding=0 at 6 months (72.0% vs. 58.1%; P=0.04). No significant differences between groups were observed for change from baseline to 6 months for total SDAI score or its components (ie, stool frequency, rectal bleeding, mucosal appearance, physician's rating of disease). Mesalamine granules treatment resulted in a significantly longer remission duration versus placebo (P=0.02) and decreased patients' risk of relapse by 43% (hazard ratio=0.57; 95% confidence interval, 0.35-0.93; P=0.02). Mesalamine granules were well tolerated, and adverse events related to hepatic, renal, and pancreatic function - potential concerns with long-term treatment - occurred at a rate similar to placebo. Conclusions: Once-daily mesalamine granules are efficacious and safe for the maintenance of UC remission. © 2015 Wolters Kluwer Health, Inc.


Lichtenstein G.R.,University of Pennsylvania | Gordon G.L.,Center for Digestive and Liver Diseases | Zakko S.,Connecticut Gastroenterology Institute | Murthy U.,Syracuse Medical Center | And 6 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2010

Background Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. Aim To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC. Methods Randomized, double-blind, placebo-controlled trial of patients (n = 209 MG, n = 96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. Results The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. Conclusions Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months. © 2010 Salix Pharmaceuticals.


PubMed | Salix Pharmaceuticals, New York Presbyterian Hospital Weill Cornell Medical Center, Connecticut Gastroenterology Institute, Center for Digestive and Liver Diseases Inc and 2 more.
Type: Clinical Trial, Phase III | Journal: Gastroenterology | Year: 2015

Budesonide is a high-potency, second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids. We performed 2 randomized, phase 3 trials to evaluate the ability of budesonide rectal foam, formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon, to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis.Two identically designed, randomized, double-blind, placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo.Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo (Study 1: 38.3% vs 25.8%; P = .0324; Study 2: 44.0% vs 22.4%; P < .0001). A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution (Study 1: 46.6% vs 28.0%; P = .0022; Study 2: 50.0% vs 28.6%; P = .0002) and endoscopic improvement (Study 1: 55.6% vs 43.2%; P = .0486; Study 2: 56.0% vs 36.7%; P = .0013) at week 6. Most adverse events occurred at similar frequencies between groups, although events related to changes in cortisol values were reported more frequently with budesonide foam. There were no cases of clinically symptomatic adrenal insufficiency.Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. ClinicalTrials.gov ID: NCT01008410 and NCT01008423.


Kasir R.,Connecticut Gastroenterology Institute | Zakko S.,Connecticut Gastroenterology Institute | Zakko P.,Connecticut Gastroenterology Institute | Adler M.,Connecticut Gastroenterology Institute | And 3 more authors.
Digestive Diseases and Sciences | Year: 2016

Background: Antibiotics for presumed small intestinal bacterial overgrowth have been shown to improve irritable bowel syndrome symptoms in at least 40 % of subjects. A lactulose breath test for small intestinal bacterial overgrowth has been used to select patients who will respond. However, its predictive value, using the classic definition of a positive lactulose breath test, has been disappointing. Aims: We conducted a retrospective evaluation to study characteristics of the lactulose breath test that may be predictive of a response to antibiotics in patients with the irritable bowel syndrome. Methods: A clinical practice database was interrogated for consecutive patients who had a lactulose breath test for irritable bowel syndrome symptoms and a subsequent antibiotic course. Hydrogen + methane levels with carbon dioxide correction were plotted against time. Various profiles of the breath test curves were catalogued and compared with respect to their predictive value for symptom response to antibiotics. Results: Lactulose breath test graphs of 561 patients of all irritable bowel syndrome subtypes were grouped into categories based on their hydrogen + methane levels with respect to time. Of subjects whose hydrogen + methane rise was <20 ppm throughout the test (group 1; N = 95), 94.7 % improved after antibiotics (95 % CI 90.1–99.3). Of those with a rise <20 ppm within the first 90 min but a rise >50 ppm thereafter (group 3; N = 53), 47.2 % improved (95 % CI 33.7–60.6). The difference between groups 1 and 3 was statistically significant P < 0.001. Conclusion: A lactulose breath test appears to be useful in predicting response to antibiotics in patients with the irritable bowel syndrome. A hydrogen + methane rise <20 ppm throughout the duration of the test is most predictive. This observation contradicts the classic definition of a positive lactulose breath test. © 2015, Springer Science+Business Media New York.


PubMed | Connecticut Gastroenterology Institute
Type: Evaluation Studies | Journal: Digestive diseases and sciences | Year: 2016

Antibiotics for presumed small intestinal bacterial overgrowth have been shown to improve irritable bowel syndrome symptoms in at least 40% of subjects. A lactulose breath test for small intestinal bacterial overgrowth has been used to select patients who will respond. However, its predictive value, using the classic definition of a positive lactulose breath test, has been disappointing.We conducted a retrospective evaluation to study characteristics of the lactulose breath test that may be predictive of a response to antibiotics in patients with the irritable bowel syndrome.A clinical practice database was interrogated for consecutive patients who had a lactulose breath test for irritable bowel syndrome symptoms and a subsequent antibiotic course. Hydrogen + methane levels with carbon dioxide correction were plotted against time. Various profiles of the breath test curves were catalogued and compared with respect to their predictive value for symptom response to antibiotics.Lactulose breath test graphs of 561 patients of all irritable bowel syndrome subtypes were grouped into categories based on their hydrogen + methane levels with respect to time. Of subjects whose hydrogen + methane rise was <20 ppm throughout the test (group 1; N = 95), 94.7% improved after antibiotics (95% CI 90.1-99.3). Of those with a rise <20 ppm within the first 90 min but a rise >50 ppm thereafter (group 3; N = 53), 47.2% improved (95% CI 33.7-60.6). The difference between groups 1 and 3 was statistically significant P < 0.001.A lactulose breath test appears to be useful in predicting response to antibiotics in patients with the irritable bowel syndrome. A hydrogen + methane rise <20 ppm throughout the duration of the test is most predictive. This observation contradicts the classic definition of a positive lactulose breath test.

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