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Temporal trends in pharmaceutical use for the treatment of ulcerative colitis [Meeting Abstract]
Lichtenstein, GR; Katz, S; Lange, JL
ISI:000224479700704
ISSN: 0002-9270
CID: 49062
Health outcomes among patients with ulcerative colitis [Meeting Abstract]
Lichtenstein, GR; Katz, S; Lange, JFL
ISI:000224479700705
ISSN: 0002-9270
CID: 49063
Pilot study on the safety and efficacy of granulocyte/monocyte adsorption apheresis with adacolumn in patients with inflammatory bowel disease [Meeting Abstract]
Sands, BE; Sandborn, WJ; Wolf, DC; Katz, S; Safdi, M; Schwartz, DA; Hanauer, SB
ISI:000224479700805
ISSN: 0002-9270
CID: 1446292
Open-label, dose-ranging pilot study of 4 weeks of low-dose therapy with sodium phosphate tablets in chronically constipated adults
Medoff, Jeffrey; Katz, Seymour; Malik, Pramod; Pambianco, Daniel; Pruitt, Ronald; Poulos, John; Rank, Jeffrey; Rose, Martin
BACKGROUND: The tablet formulation of sodium phosphate (NaP) is a prescription osmotic purgative that has been marketed since 2001. The use of NaP tablets in patients with constipation has not been studied previously. OBJECTIVE: This study assessed the tolerability and efficacy of 28 days of therapy with NaP tablets (1.5 g NaP/tablet) in patients with chronic constipation. METHODS: Adults with functional constipation or constipation-predominant irritable bowel syndrome and Z-3 spontaneous bowel movements (BMs) during the 7-day screening/baseline period were eligible for this open-label, dose-ranging study. Patients were randomized to receive starting doses of 4 NaP tablets (group A) or 8 NaP tablets (group B) each morning for 28 days. After a minimum of 48 hours, the NaP dose could be titrated upward (in the case of no BM or no relief of symptoms) or downward (in the case of a predefined excess laxative response) by 2 tablets/d to a minimum of 2 tablets/d or a maximum of 12 tablets/d. Patients kept a diary of their BMs and gastrointestinal symptoms. A serum chemistry panel was obtained weekly. The primary end points were the constipation response (based on the change from baseline in weekly number of BMs) and the global sense response (based on daily scores for the patient's overall sense of change in their bowel problems). RESULTS: At randomization, there were 18 patients in group A and 25 in group B. Of these, 40 patients (16 group A, 24 group B) had > or 7 days of diary information while taking study treatment and were evaluable for efficacy. The constipation response rate was 100% in group A and 95.8% in group B, and the respective global sense response rates were 68.8% and 79.2%. Four patients in group B withdrew due to adverse events, none of which were serious. Five patients had occasional hypokalemia that required no treatment. Changes from baseline in serum concentrations of calcium, inorganic phosphorus, and potassium were not clinically significant and did not require treatment. CONCLUSIONS: In this small study, NaP tablets taken daily were generally well tolerated (particularly in the low-dose group) and produced prompt relief of constipation--generally within the first week of treatment--that was sustained over the 28-day treatment period. A reasonable starting dose appears to be 2 to 4 tablets (3-6 g NaP) daily
PMID: 15531010
ISSN: 0149-2918
CID: 114408
Safety and tolerability of natalizumab in patients concurrently receiving infliximab in a phase 2 study of active Crohn's disease [Meeting Abstract]
Sands, BE; Kozarek, RA; Spainhour, J; Barish, C; Becker, S; Goldberg, LS; Katz, S; Hanauer, SB
ISI:000220890202326
ISSN: 0016-5085
CID: 1446272
Semapimod treatment of Crohn's disease [Meeting Abstract]
Buchman, AL; Katz, S; Barish, C; Elkin, R; Korzenik, J; Plasse, T
ISI:000220890202333
ISSN: 0016-5085
CID: 1446282
Repifermin (keratinocyte growth factor-2) for the treatment of active ulcerative colitis: a randomized, double-blind, placebo-controlled, dose-escalation trial
Sandborn, W J; Sands, B E; Wolf, D C; Valentine, J F; Safdi, M; Katz, S; Isaacs, K L; Wruble, L D; Katz, J; Present, D H; Loftus, E V Jr; Graeme-Cook, F; Odenheimer, D J; Hanauer, S B
BACKGROUND: Repifermin (keratinocyte growth factor-2) has been shown to reduce inflammation in animal models of colitis. AIM: To evaluate repifermin for the treatment of active ulcerative colitis. METHODS: Eighty-eight patients with active ulcerative colitis were enrolled in a 6-week, double-blind trial. Patients were randomized to receive treatment for five consecutive days with intravenous repifermin at a dose of 1, 5, 10, 25 or 50 microg/kg, or placebo. The primary objective of the study was to evaluate the safety of repifermin. The primary efficacy outcome was clinical remission at week 4, defined as a score of zero on the endoscopic appearance and stool blood components of the Mayo score and a score of zero or unity on the stool frequency and physician's global assessment components. RESULTS: At week 4, the rates of clinical remission in the 1, 5, 10, 25 and 50 microg/kg repifermin groups were 19%, 9%, 0%, 0% and 0%, respectively, and 11% for the placebo group (P = 0.32 for repifermin vs. placebo). The frequencies of commonly occurring adverse events and severe adverse events were similar in both groups. CONCLUSIONS: Intravenous repifermin at a dose of 1-50 microg/kg was very well tolerated, but there was no evidence that repifermin was effective for the treatment of active ulcerative colitis at these doses. An additional study to determine the efficacy of repifermin at doses of > 50 microg/kg or for a longer treatment duration may be warranted, as the maximally tolerated dose was not reached in the present study.
PMID: 12786629
ISSN: 0269-2813
CID: 1446152
Pulmonary manifestations of inflammatory bowel disease
Storch, Ian; Sachar, David; Katz, Seymour
Extraintestinal manifestations of both Crohn's disease and ulcerative colitis (UC) have been well described, although pulmonary findings are often overlooked. We summarize the experience of more than 400 cases of pulmonary manifestations of inflammatory bowel disease (IBD). These manifestations will be categorized by disease mechanism into drug-induced disease, anatomic disease, over-lap syndromes, autoimmune disease, physiologic consequences of IBD, pulmonary function test abnormalities, and nonspecific lung disease. We intend to provide the clinician with a practical working update on the spectrum of pulmonary dysfunction associated with IBD
PMID: 12769444
ISSN: 1078-0998
CID: 114409
Small Bowel Diverticulosis: An Overlooked Entity
Gross SA; Katz S
Small bowel diverticulosis (SBD) is a rare entity. Most cases of diverticulosis are asymptomatic. SBD is often discovered incidentally during contrast studies and endoscopy. When patients report chronic gastrointestinal symptoms such as abdominal pain, bloating, flatulence, and anemia, SBD is often an overlooked diagnosis. Patients requiring treatment for SBD are those with complications such as malabsorption, hemorrhage, obstruction, and acute inflammation with abscess or rarely perforation. Malabsorption can be managed with broad-spectrum antibiotics and vitamin supplementation. Hemorrhage is treated conservatively with resuscitation efforts, but recurrent bleeding requires surgery. Enteroliths causing obstruction in the duodenum can be relieved by endoscopy, that is, by manipulation, but jejunoileal obstruction requires a resection. Pseudo- obstruction may be managed with prokinetics such as metoclopramide, erythromycin, and the 5-hydroxytryptamine 4 agonist tegaserod. Uncomplicated cases of SBD are treated with bowel rest and antibiotics. However, perforation or abscess formation not amenable to percutaneous drainage mandates surgical resection. Any patient with a triad of anemia, abdominal pain, and an abdominal radiograph with dilated loops of small bowel merits SBD in the differential diagnosis
PMID: 12521566
ISSN: 1534-309x
CID: 114410
Variation at NOD2/CARD15 in familial and sporadic cases of Crohn's disease in the Ashkenazi Jewish population
Zhou, Zhifeng; Lin, Xing-Yu; Akolkar, Pradip N; Gulwani-Akolkar, Beena; Levine, Jeremiah; Katz, Seymour; Silver, Jack
OBJECTIVE: Recent reports indicate that allelic variants in NOD2/CARD15 are associated with Crohn's disease (CD) susceptibility, and that homozygosity or compound heterozygosity at this locus for any of three recently defined sequence variants confers a greatly increased risk of CD. These sequence changes include two missense mutations, R702W and G908R, and a frameshift insertion, 1007insC. The aim of this study was to determine the frequency of these NOD2/CARD15 variants in familial and sporadic CD patients in the Ashkenazi population and to determine their effects on disease susceptibility and age of disease onset (AOO). METHODS: Allele and genotype frequencies of these three variants were determined in 481 CD patients of Jewish descent and 110 Jewish controls; 169 patients had a family history of CD, and 312 were 'sporadic' cases. Variants were detected by polymerase chain reaction using allele-specific primers labeled with fluorescent dye. RESULTS: Familial cases had a significantly higher frequency of the G908R variant than sporadic cases (0.127 vs 0.059, p = 0.0003) and correspondingly, a significantly higher proportion of homozygotes and compound heterozygotes (11.8% vs 4.5%, p = 0.0027). Homozygotes and compound heterozygotes had an OR for CD of 14.6 for familial cases and 5.1 for sporadic cases. There was no increased risk of CD for simple heterozygotes. The AOO was significantly lower for CD patients who were homozygotes and compound heterozygotes for NOD2/CARD15 (17.5 vs 22.4 yr, p = 0.04), but only for familial cases. CONCLUSIONS: NOD2/CARD15 contributes more to CD susceptibility in familial cases than in sporadic cases, and to an earlier AOO. There is no increased risk of CD for individuals carrying only a single copy of these NOD2/ CARD15 variants, whereas individuals carrying two copies have a 5-15-fold increased risk. The penetrance of the NOD2/CARD15 mutations was estimated at less than 1%
PMID: 12492195
ISSN: 0002-9270
CID: 62321