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Biomedical subjects

James M Scheiman

Publications and source records attributed to James M Scheiman.

29 records · Page 2Linked to original sources
PubMed2003

Gastroduodenal safety of cyclooxygenase-2 inhibitors.

Cyclooxygenase-1 (COX-1) derived eicosanoids promote gastroprotective mucosal defenses and induce platelet aggregation. By sparing COX-1, COX-2 specific inhibitors provide effective anti-inflammatory and analgesic activity while substantially reducing the risk of peptic ulcer disease and GI bleeding compared to dual COX inhibitors (traditional NSAIDs). Clinical studies of the COX-2-selective inhibitors have demonstrated efficacy equivalent to nonselective NSAIDs with significantly lower rates of GI toxicity. The incidence of endoscopic ulcers in some studies with coxibs has approximated placebo. However, as the detection of endoscopic lesions is not always correlated with symptomatic ulcers and ulcer complications, outcome studies of GI safety were performed. The results of large outcome studies have evaluated rofecoxib and celecoxib in over 39,000 patients with osteoarthritis or rheumatoid arthritis. Results of these studies showed that patients taking a supratherapeutic dose of rofecoxib or celecoxib had significantly lower rates of GI-related adverse events than those taking a nonselective NSAID. The GI safety of coxibs for patients using low dose aspirin concomitantly with a coxib appears to be reduced, particularly with regard to ulcer complications. Such data provide support for the COX-2 hypothesis and demonstrate that coxibs provide effective treatment of pain and inflammation with a reduced risk of gastropathy.

Animals↗
PubMed2002

Role of initial NSAID choice and patient risk factors in the prevention of NSAID gastropathy: a decision analysis.

OBJECTIVE: To investigate the role of initial nonsteroidal antiinflammatory drug (NSAID) choice in the prevention of NSAID gastropathy, based on relative clinical and economic effects. METHODS: To mimic clinical practice, a symptom-driven decision analytic model was constructed to compare 2 treatment strategies for long-term users of NSAIDs over a 1-year period: Strategy 1-generic NSAID used initially, and safer, more expensive NSAID reserved for treatment failures due to symptomatic gastropathy; and Strategy 2-safer, more expensive NSAID used in all instances. The only distinction between the strategies was the choice of initial NSAID. NSAIDs differed in gastrointestinal safety profiles and acquisition costs. The use and impact of antisecretory medications were included in the model. Because published data on patients' ulcer risk and relative NSAID safety show considerable variability, sensitivity analyses were used to evaluate the key clinical outcomes and costs. RESULT: For patients without risk factors for NSAID ulcers (average risk), the model estimated that the strategy restricting use of the safer NSAID resulted in more symptomatic ulcers (Strategy 1, 2.58; Strategy 2, 0.73) and ulcer-related complications (Strategy 1, 1.18; Strategy 2, 0.23) per 100 patient years. The restricted strategy led to a significantly lower cost per patient treated (Strategy 1, $239; Strategy 2, $831 per year). In the principal analysis, the incremental costs to prevent symptomatic and complicated ulcers were $31,900 and $56,700, respectively. The estimated incremental cost per ulcer avoided was sensitive to the relative protection provided by the safer NSAID and fell dramatically as the patients' ulcer risk was increased above average risk. CONCLUSION: Unrestricted use of NSAIDs that reduce the risk of symptomatic ulcers has the potential to produce important clinical benefits at incremental cost. The impressive impact of ulcer risk on the incremental cost per ulcer prevented warrants increased attention to risk factor identification when NSAIDs are prescribed.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2002

Nonmucinous cystic pancreatic neoplasms.

This article discusses serous cystadenomas, the most common of the nonmucinous cystic lesions of the pancreas. These microcystic lesions were previously known as "glycogen-rich" cystadenomas because of the presence of glycogen within the cyst epithelium. A small percentage of these lesions are macrocystic, and it may be difficult to differentiate them from mucinous lesions; however, endoscopic ultrasound guided fine needle aspiration can provide diagnostic material from the cyst fluid. The second most common nonmucinous cyst, the islet cell tumor, is also discussed. These rare cystic tumors may or may not be accompanied by excess hormone production. The prognosis for the rare cystic tumors is good if they are resected successfully.

Adenoma, Islet Cell↗
PubMed2002

Initial experience with an electronic radial array echoendoscope: randomized comparison with a mechanical sector scanning echoendoscope in humans.

BACKGROUND: An electronic radial array echoendoscope has been developed that uses the same US processor as the linear array instruments made by the same company, thereby eliminating the need for two processors. The performance of this prototype instrument was compared with that of a mechanical radial echoendoscope in patients. METHODS: Fourteen patients underwent sequential examinations with both echoendoscopes in random order. Predefined criteria were used to evaluate the performance of each instrument. RESULTS: The quality of the electronic radial image was rated as "good" or "superior" to that of the mechanical radial echoendoscope in 12 patients. In 2 patients, imaging with the prototype was inferior because of positioning and/or operator inexperience. The forward-viewing optics of the prototype enhanced intubation and instrument advancement. Limitations included excessive stiffness of the tip of the instrument that resulted in occasional slippage from the duodenum. The prototype provided an adequate diagnosis in 12 patients and was superior to the mechanical radial endoscope in terms of diagnosis in 2 cases. CONCLUSION: The prototype electronic radial echoendoscope provides US images of similar quality and is equivalent in terms of clinical utility to the mechanical radial echoendoscope.

Adult↗
PubMed2002

Helicobacter pylori test-and-treat intervention compared to usual care in primary care patients with suspected peptic ulcer disease in the United States.

OBJECTIVES: [corrected] The Helicobacter pylori (H. pylori) "test-and-treat" strategy in uninvestigated dyspepsia is an effective alternative to prompt endoscopy. Our aims were to determine whether the combination of an educational session and availability of office-based H. pylori testing (test-and-treat intervention [TTI]) increases use of the test-and-treat strategy by primary care practitioners and whether it improves patient outcomes. METHODS: We conducted a 1-yr prospective trial of patients with suspected peptic ulcer disease in six primary care centers, three with TTI and three designated as usual care controls (UCC). RESULTS: H. pylori testing was performed in 81% of 54 TTI patients and in 49% of 39 UCC patients (p = 0.004). TTI and UCC patients had similar gastroenterology referral rates (24% vs 33%, p = 0.33), endoscopy or upper GI radiography rates (30% vs 31%, p = 0.91), and primary care visits per patient (3.1 +/- 2.8 vs 3.1 +/- 2.6, p = 0.92). TTI patients were less likely than UCC patients to receive repeated antisecretory medication prescriptions (35% vs 66%, p = 0.003). Symptomatic status at 1 yr and satisfaction with medical care did not differ between groups. Median (and interquartile range) annualized disease-related expenditures per patient were $454 ($162-932) for TTI and $576 ($327-1,435) for UCC patients (p = 0.17). CONCLUSIONS: The combination of an educational session and availability of office-based H. pylori testing may increase acceptance of the test-and-treat strategy by primary care providers. It remains to be determined whether increased use of the test-and-treat strategy yields significant improvements in clinical and economic outcomes compared to usual care.

Adult↗
PubMed2002

Outcomes studies of the gastrointestinal safety of cyclooxygenase-2 inhibitors.

Short-term endoscopic studies of the highly selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) rofecoxib and celecoxib have shown that these agents are well tolerated and have efficacy equivalent to nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with fewer adverse effects on the upper gastrointestinal (GI) tract. These studies are limited, however, as the detection of endoscopic lesions is not well correlated with symptomatic ulcers and ulcer complications. Outcomes studies of the GI safety are, therefore, essential to understanding how coxibs are likely to perform in a clinical practice setting. Four large outcomes studies (Vioxx Gastrointestinal Outcomes Research, VIGOR; Assessment of Difference Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness trial, ADVANTAGE; Celecoxib Long-term Arthritis Safety Study, CLASS; and the Successive Celecoxib Efficacy and Safety Studies, SUCCESS) examined the GI safety of rofecoxib and celecoxib in over 39,000 patients with osteoarthritis or rheumatoid arthritis. Results of these studies showed that patients taking a supratherapeutic dose of rofecoxib or celecoxib had significantly lower rates of GI-related adverse events than those taking a nonselective NSAID (naproxen, ibuprofen, or diclofenac). Reduced risk of upper GI events was seen in patients with multiple risk factors and in patients using low-dose aspirin and corticosteroids concomitantly with a coxib. Results of large outcomes studies provide support for the COX-2 hypothesis and demonstrate the long-term safety and tolerability of coxibs.

Arthritis↗
PubMed2002

Gastrointestinal outcomes: evidence for risk reduction in patients using coxibs.

This paper examines the importance of clinically relevant gastrointestinal (GI) outcomes in patients using nonsteroidal anti-inflammatory drugs (NSAIDs) and the risk reduction for adverse GI events associated with cyclooxygenase (COX)-2-selective inhibitors. Four large outcomes trials are reviewed, 2 each with celecoxib and rofecoxib. The results of outcomes studies are consistent with randomized controlled trials and demonstrate that coxibs are associated with significant reductions in clinically relevant GI outcomes. The reductions are observed in patients without GI risk factors as well as in those at risk, suggesting that these drugs have the potential to improve outcomes for all patients requiring NSAIDs.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMedDate not supplied

Endoscopic ultrasound-guided fine needle aspiration of the pancreas. Diagnostic utility and accuracy.

OBJECTIVE: Endoscopic ultrasound-guided fine needle aspiration biopsy (EUS-FNAB) is regarded as a safe and reliable procedure for diagnosing and staging of pancreatic neoplasms. This study retrospectively evaluated both the diagnostic utility and accuracy of pancreatic EUS-FNABs and potential cytologic pitfalls when using Diff-Quik stain for on-site evaluation. STUDY DESIGN: Pancreatic EUS-FNABs performed between 1995 and 1998 were identified from the files of the Department of Pathology. All patients were studied via a linear-array ultrasound endoscope with an FNAB device. Immediate evaluation of the specimen by a pathologist using air-dried slides and Diff-Quik stain was done on all cases. An average of five passes (range, three to nine) were performed. Five cytologic categories were identified: nondiagnostic, benign, atypical, suspicious and malignant. EUS disease staging, histologic correlation and clinical follow-up were reviewed. RESULTS: Sixty-nine consecutive pancreative FNABs were evaluated in the study period. The patients comprised 38 females and 31 males with a mean age of 65 years (range, 36-83). Histologic correlation was available on 40 patients, and follow-up was available on the remaining 29. The cytologic diagnoses included: 31 malignant, 8 suspicious, 6 atypical, 20 benign and 4 nondiagnostic. Forty-three cases were true positive, 9 were true negative, 2 were false positive, and 11 were false negative. The overall sensitivity was 80% and specificity was 82%. CONCLUSION: The study showed that cytologic evaluation of pancreatic EUS-FNABs has 80% sensitivity and 82% specificity. False negative diagnosis was usually due to sampling error. A nondiagnostic cytologic diagnosis should be rendered in the absence of adequate sampling of a lesion. On-site cytologic evaluation of EUS-FNABs aids in guaranteeing specimen adequacy, and the pathologist should be trained to evaluate Diff-Quik-stained samples.

Adenocarcinoma↗