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James Aisenberg

Publications and source records attributed to James Aisenberg.

13 recordsLinked to original sources
PubMed2006

A multicenter, randomized, double-blind, active-comparator, placebo-controlled, parallel-group comparison of the incidence of endoscopic gastric and duodenal ulcer rates with valdecoxib or naproxen in healthy subjects aged 65 to 75 years.

BACKGROUND: Compared with nonselective NSAIDs, cyclooxygenase (COX)-2-selective inhibitors have been associated with a lower incidence of gastroduodenal ulcers (in short-term endoscopic studies) and ulcer complications (in long-term trials). OBJECTIVE: The aim of this study was to compare the effects of valdecoxib 20 mg BID and naproxen 500 mg BID, administered for 6.5 days, on the upper gastrointestinal (UGI) mucosa of healthy older subjects (aged 65-75 years) as assessed by UGI endoscopy. METHODS: In this multicenter, double-blind, active-comparator, placebo-controlled, parallel-group study, eligible subjects who were free of NSAID or COX-2-selective inhibitor use for 2 weeks and who had normal UGI mucosa (mucosal grading score of 0, based on endoscopic evaluation of both the stomach and duodenum) were randomized. Serologic testing for Helicobacter pylori antibodies was conducted at baseline. No antiulcer medications were permitted. The primary end point was the incidence of gastroduodenal ulcers (gastric or duodenal mucosal grading score of 7, as indicated by any lesion with unequivocal depth > or =3 mm in diameter) after 6.5 days of blinded treatment with valdecoxib, naproxen, or placebo. Secondary end points were incidence of gastric ulcers, duodenal ulcers, and gastroduodenal erosions/ulcers, and the incidence of > or =11 gastroduodenal erosions/ulcers. All documented adverse events were self-reported by subjects or were observed by investigators. RESULTS: Sixty-one patients were randomized to receive valdecoxib, 60 to naproxen, and 60 to placebo. Mean (SD) subject age was 68.8 (3.25) years in the valdecoxib group, 68.6 (2.76) years in the naproxen group, and 68.6 (3.14) years in the placebo group (P = NS). In the valdecoxib and naproxen groups, 47.5% and 58.3% of subjects were female, respectively, compared with 56.7% of the placebo group (P = NS). Valdecoxib and placebo were associated with significantly lower incidences of gastroduodenal ulcers than naproxen (1.6% [1 gastroduodenal ulcer/61 patients] and 1.7% [1/59], respectively, vs 22.0% [13/59]; P < 0.001). Compared with naproxen, both valdecoxib and placebo were associated with significantly lower incidences of gastric (1.6% [1/61] and 1.7% [1/59] vs 15.3% [9/59]; both, P < 0.03) and duodenal ulcers (0% [0/61] and 0% [0/59] vs 8.5% [5/59]; both,P < 0.03). In all cases, the incidence of ulcers with valdecoxib was not significantly different from placebo. Results were similar for any erosions/ulcers, and when analyzed by H pylori status. The number of adverse events was low in each group. CONCLUSION: In these healthy older subjects (aged 65-75 years), valdecoxib 20 mg BID was associated with a significantly lower rate of gastroduodenal, gastric, and duodenal ulcers than naproxen 500 mg BID, even after 6.5 days of therapy.

Aged↗
PubMed2006

Sedation in endoscopic practice.

Sedation impacts every aspect of endoscopy practice--the quality fo the examination, the satisfaction of endoscopist and of patient, the efficiency and cost of delivering services, and the compliance of patients with surveillance guidelines. New sedation agents and improved patient-monitoring and drug-delivery technologies are challenging traditional practices. Increasing demand for endoscopic services, shrinking reimbursements, and competing diagnostic technologies are prompting recognition that new approaches to sedation can improve practice efficiency and patient outcome. This article discusses new developments in endoscopic sedation and their implications for practice management.

Anesthesiology↗
PubMed2006

Endoscopic sedation in the United States: results from a nationwide survey.

OBJECTIVES: The introduction of new sedative agents as well as a desire for improved patient satisfaction and greater efficiency has changed the practice of endoscopic sedation. This survey was designed to provide national and regional data on endoscopic sedation and monitoring practices within the United States. METHODS: A 22-item survey regarding current practices of endoscopy and sedation was mailed to 5,000 American College of Gastroenterology physician members nationwide. RESULTS: A total of 1,353 questionnaires (27.1%) were returned. Respondents performed an average of 12.3 esophagogastroduodenoscopies (EGDs) and 22.3 colonoscopies per wk. Endoscopic procedures were performed within a hospital setting (55.2) more often than at an ambulatory center (35.8%) or private office (8.8%). The vast majority of EGDs and colonoscopies (>98%) were performed with endoscopic sedation. Almost three quarters (74.3%) of the respondents used a narcotic and benzodiazepine for sedation, while propofol was preferred by 25.7%. Sedation practices varied considerably within different geographic regions of the United States. Respondents routinely monitored vital signs and pulse oximetry (99.2% and 98.6%, respectively), and supplemental oxygen was administered to all patients during EGD by 72.7% of endoscopists. Endoscopist satisfaction with sedation was greater among those using propofol than conventional sedation (10 vs 8, p < 0.0001). CONCLUSIONS: During the past 15 yr, the volume of procedures performed by endoscopists in the United States has increased two- to fourfold. Propofol is currently being used for sedation in approximately one quarter of all endoscopies in the United States. The findings from this survey may help in the formulation of updated policies and practice guidelines pertaining to endoscopic sedation.

Adult↗
PubMed2005

Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months.

BACKGROUND: Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. METHODS: An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. RESULTS: At 12 months, PPI use was reduced > or =50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL < or =11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a > or =50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients. CONCLUSIONS: This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

Belgium↗
PubMed2005

Innate immune receptor genetic polymorphisms in pouchitis: is CARD15 a susceptibility factor?

BACKGROUND: Pouchitis is a frequent complication after ileal pouch-anal anastamosis (IPAA) for ulcerative colitis (UC). The aim of this study was to determine whether genetic polymorphisms in the innate immune receptors toll-like receptor (TLR)4 and caspase activation and recruitment domain family member 15 (CARD15) genes are associated with pouchitis. METHODS: From a retrospectively ascertained cohort of patients with UC 5 to 12 years after IPAA (n = 101), subjects were classified into 3 groups: no pouchitis (n = 52); 1 to 2 episodes per year (n = 11), and more than 2 episodes per year (n = 38). Single nucleotide polymorphisms in the tlr4 gene (D299G, T399I) were determined by a real-time polymerase chain reaction-based fluorogenic probe technique; and card15 polymorphisms (L1007fsinsC, R702W, G908R) were determined by pyrosequencing. RESULTS: Pouchitis affected 49% (49/101) of the study population. No correlation between pouchitis and the presence of TLR4 polymorphisms was found. The percentage of patients who harbored CARD15 mutations was significantly higher in patients with pouchitis than in patients without pouchitis (18% versus 8%; P < 0.05); 24% of pouchitis patients with more than 2 episodes per year harbored CARD15 mutations (P < 0.01 compared with the no pouchitis group). The CARD15 insertion mutation L1007fsinsC was present in 14% of patients with pouchitis and in 0% without pouchitis (P < 0.05). All patients who carried L1007fsinsC developed more than 2 episodes per year. CONCLUSIONS: CARD15 polymorphisms are seen in greater frequency in patients with pouchitis after IPAA for UC. These findings, if borne out in prospective analyses, suggest that CARD15 mutations, particularly L1007fsinsC, may predispose to the development of pouchitis after IPAA for UC.

Adult↗
PubMed2004

Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam.

BACKGROUND: Propofol provides several benefits over benzodiazepine and narcotic agents as a sedative medication for endoscopic procedures, including faster recovery and improved patient satisfaction. However, its use generally has been limited to anesthesiologists because of the risks associated with deep sedation. METHODS: One hundred patients undergoing colonoscopy or EGD were sedated with low-dose propofol, midazolam, and fentanyl (or meperidine). Depth of sedation was assessed at 2-minute intervals by an independent observer by using the American Society of Anesthesiologists criteria. Recovery time was determined by using paired neuropsychometric tests. A post-procedure satisfaction survey and 24-hour follow-up questionnaires were administered. RESULTS: For colonoscopy and EGD, respectively, the mean propofol dose was 98 mg and 79 mg, the mean midazolam dose was 0.9 mg and 0.8 mg, the mean fentanyl dose was 69 mcg and 63 mcg, and the mean meperidine dose was 42 mg (for both procedures). There were 628 assessments of the level of sedation performed during 74 colonoscopies and 101 assessments during 26 EGDs. The level of sedation was minimal in 77%, moderate in 21%, and deep in 2% of assessments. Nine of the 13 episodes of deep sedation were recorded during colonoscopy and 4 during EGD. In no instance was more than a single assessment of deep sedation recorded during one procedure. Ninety-eight percent of patients were satisfied with the sedation, and 71% returned to their usual activities within 2 hours of discharge. There was no serious adverse event. CONCLUSIONS: Endoscopic sedation with low-dose propofol, a narcotic agent, and midazolam produces a moderate level of sedation. The quality of sedation and measures of recovery are comparable with the results reported with standard-dose propofol.

Adult↗
PubMed2004

Are pANCA, ASCA, or cytokine gene polymorphisms associated with pouchitis? Long-term follow-up in 102 ulcerative colitis patients.

OBJECTIVE: Pouchitis is the most frequent complication after ileal pouch-anal anastomosis for ulcerative colitis. This study aims to analyze the frequency and characteristics of pouchitis in long-term follow-up in a large population, and to determine whether a significant association exists between five immunogenetic markers and pouchitis. METHODS: From a population of over 500 ulcerative colitis patients who had undergone ileal pouch-anal anastamosis 5-12 yr earlier, 102 subjects participated in the study. Using clinical data obtained from interviews and chart reviews, patients were classified into three groups: no pouchitis; 1-2 episodes per year; and >2 episodes per year. Coded sera from the patients were analyzed for ulcerative colitis-associated perinuclear antineutrophil cytoplasmic antibodies and Crohn's disease-associated anti-saccharomyces cerevesiae antibodies. Interleukin-1 receptor antagonist, tumor necrosis factor (TNF), and lymphotoxin beta (lymphotoxin) polymorphisms were also analyzed. RESULTS: Pouchitis affected 49% of the study population. Antineutrophil cytoplasmic antibodies, anti-saccharomyces cerevesiae antibodies, and lymphotoxin-beta polymorphisms were not associated with pouchitis. Carriage of interleukin-1 receptor antagonist allele 2 was significantly greater among those without pouchitis than those with pouchitis. Patients without pouchitis had a significantly greater carriage rate of TNF allele 2. CONCLUSIONS: Perinuclear antineutrophil cytoplasmic antibodies and anti-saccharomyces cerevesiae antibodies are not correlated with pouchitis, but interleukin-1 receptor antagonist and TNF may play a role in its development. Further evaluation of these markers in pouchitis will require larger populations, long-term prospective observation, and studies that correlate polymorphisms with specific immunologic functions.

Adult↗
PubMed2003

Propofol for endoscopic sedation: A protocol for safe and effective administration by the gastroenterologist.

BACKGROUND: There is increasing interest in the use of propofol, an ultrashort-acting hypnotic agent, for sedation during endoscopic examinations. A protocol was developed for administration of propofol, combined with small doses of midazolam and meperidine, for endoscopic sedation under the direction of a gastroenterologist. Initial experience with using this protocol is described. METHODS: A total of 819 consecutive endoscopic examinations under sedation with propofol, midazolam, and meperidine (or fentanyl), in adherence with the sedation protocol, were reviewed retrospectively. RESULTS: There were 638 colonoscopies and 181 EGDs; 89% of patients were classified as American Society of Anesthesiologists (ASA) class I or II. Mean dosages of medications were: propofol 63 (33.5) mg, meperidine 48 (7.2) mg, and midazolam 1 (0.12) mg. The dose of propofol was inversely correlated with age and ASA class, and positively correlated with patient weight and duration of examination. Hypotension (>20 mm Hg decline in either systolic or diastolic blood pressure) developed in 218 (27%) patients, and hypoxemia (oxygen saturation <90%) developed in 75 (9%). All episodes of hypotension and hypoxemia were transient, and no patient required administration of a pharmacologic antagonist or assisted ventilation. The average time for recovery after colonoscopy and after EGD was, respectively, 25 minutes and 28 minutes. All EGDs and 98% of colonoscopies were completed successfully. CONCLUSIONS: On the basis of this initial experience, it is believed that propofol, potentiated by small doses of midazolam and meperidine, can be safely and effectively administered under the direction of a gastroenterologist. Additional research will be necessary to determine whether propofol is superior to the current methods of sedation.

Adolescent↗
PubMed2003

Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.

OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

Biopolymers↗
PubMed2003

Endoscopic implantation of enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial.

OBJECTIVES: This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD). METHODS: In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2-4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by >/=50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events. RESULTS: At 12 months, 80.3% (95% CI = 69.9%-88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by >/=50%. Treatment response was more likely in patients with residual implant volume of >/=5 mL (p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline (p < 0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH <4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication. CONCLUSIONS: Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.

Adult↗