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Biomedical subjects

James M Scheiman

Publications and source records attributed to James M Scheiman.

At least 19 recordsLinked to original sources
PubMed2006

Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors.

OBJECTIVES: Proton pump inhibitors reduce ulcer recurrence in non-steroidal anti-inflammatory drug (NSAID) users, but their impact in at-risk ulcer-free patients using the current spectrum of prescribed agents has not been clearly defined. We assessed esomeprazole for ulcer prevention in at-risk patients (> or = 60 yr and/or ulcer history) taking NSAIDs, including COX-2 inhibitors. Such studies are particularly relevant, given that concerns regarding adverse cardiovascular outcomes among COX-2 inhibitor users may prompt re-evaluation of their use. METHODS: We conducted two similar double-blind, placebo-controlled, randomized, multicenter studies; VENUS (United States) and PLUTO (multinational). A total of 844 and 585 patients requiring daily NSAIDs, including COX-2 inhibitors were randomized to receive esomeprazole (20 or 40 mg) or placebo, daily for 6 months. RESULTS: In the VENUS study, the life table estimated proportion of patients who developed ulcers over 6 months (primary variable, intent-to-treat population) was 20.4% on placebo, 5.3% on esomeprazole 20 mg (p < 0.001), and 4.7% on esomeprazole 40 mg (p < 0.0001). In the PLUTO study, the values were 12.3% on placebo, 5.2% with esomeprazole 20 mg (p = 0.018), and 4.4% with esomeprazole 40 mg (p = 0.007). Significant reductions were observed for users of both non-selective NSAIDs and COX-2 inhibitors. Pooled ulcer rates for patients using COX-2 inhibitors (n = 400) were 16.5% on placebo, 0.9% on esomeprazole 20 mg (p < 0.001) and 4.1% on esomeprazole 40 mg (p= 0.002). Esomeprazole was well tolerated and associated with better symptom control than placebo. CONCLUSIONS: For at-risk patients, esomeprazole was effective in preventing ulcers in long-term users of NSAIDs, including COX-2 inhibitors.

Aged↗
PubMed2006

Industry funding.

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Health Care Sector↗
PubMed2006

New advances in pancreatic imaging.

PURPOSE OF REVIEW: This review serves to highlight new technology and novel applications of existing techniques and their role in the management of pancreatic diseases, including acute and chronic pancreatitis, pancreatic cancer, and pancreatic cystic neoplasms. RECENT FINDINGS: Contrast-enhanced ultrasound has shown promise in evaluating the severity of acute pancreatitis, staging pancreatic cancer, and predicting malignancy in cystic neoplasms. Optical coherence tomography within the pancreatic duct appears to be able to differentiate malignant and normal pancreatic ducts. Spectroscopy may prove useful in differentiating focal chronic pancreatitis from malignancy. Multidetector-row computed tomography may provide more accurate information regarding cancer respectability and differentiation between ductal type of intraductal papillary mucinous tumors. SUMMARY: These new developments will help with the diagnosis and staging of pancreatic diseases.

Acute Disease↗
PubMed2006

Unmet needs in non-steroidal anti-inflammatory drug-induced upper gastrointestinal diseases.

The use of traditional and cyclooxygenase (COX)-2-selective non-steroidal anti-inflammatory drugs (NSAID) for the relief of pain and inflammation increases the risk of gastrointestinal side-effects ranging from dyspepsia to symptomatic and complicated ulcers. The COX-2-selective agents were designed to provide comparable pain relief to traditional NSAID, with a reduced rate of adverse gastrointestinal events. However, there appears to be little clinically significant difference between COX-2 and traditional NSAID in terms of dyspepsia, a common cause of the discontinuation of a traditional NSAID. Furthermore, concomitant aspirin use substantially reduces the gastrointestinal safety advantage of COX-2-selective drugs. An increase in the numbers of people taking low-dose aspirin for cardioprotection, an aging population and potential chemoprevention benefits are resulting in the rising consumption of NSAID. Proton pump inhibitors have a demonstrated role in the treatment and prevention of both non-selective NSAID and selective COX-2 inhibitor-related upper gastrointestinal damage. However, the use of gastroprotective agents is far from optimal, and many high-risk patients are not being clearly identified. At the same time, inappropriate low-dose aspirin use is placing low cardiovascular risk patients at risk of gastrointestinal bleeding. Combined with the recent withdrawal of rofecoxib and valdecoxib from the market because of excess cardiovascular adverse events, and concerns about the safety of other COX-2 inhibitors, a review of strategies to reduce the overall risks in users of anti-inflammatory drugs is timely. This article examines the current issues of understanding and managing NSAID-induced upper gastrointestinal diseases.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2005

Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors and NSAIDs.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective in treating the pain and inflammation associated with osteoarthritis and rheumatoid arthritis, but it is well recognized that these agents are associated with substantial gastrointestinal toxicity. Treatment guidelines suggest that patients with one or more risk factors for NSAID associated ulcers should be prescribed preventive treatment. However, well over 80% of such patients may not receive an appropriate therapeutic intervention. Multiple strategies are available to reduce the risk for NSAID associated gastrointestinal complications. First, risk may be reduced by using non-NSAID analgesics. Second, use of the minimum effective dose of the NSAID may reduce risk. Third, co-therapy with a proton pump inhibitor or misoprostol may be desirable in at-risk patients. Use of cyclo-oxygenase-2 inhibitors may also reduce the risk for gastrointestinal events, although this benefit is eliminated in patients who receive aspirin, and cyclo-oxygenase-2 inhibitors may increase cardiovascular adverse events. The optimal management of NSAID related gastrointestinal complications must be based on the individual patient's risk factors for gastrointestinal and cardiovascular disease, as well as on the efficacy and tolerability of both the NSAID and accompanying gastroprotective agent.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2005

Improvements with esomeprazole in patients with upper gastrointestinal symptoms taking non-steroidal antiinflammatory drugs, including selective COX-2 inhibitors.

OBJECTIVES: Upper gastrointestinal (GI) symptoms are common in patients using non-steroidal antiinflammatory drugs (NSAIDs) including selective cyclooxygenase (COX)-2 inhibitors and may be acid related. We therefore assessed esomeprazole treatment for upper GI symptoms in these patients. METHODS: A total of 794 and 848 continuous NSAID users, free of gastroduodenal ulcers, erosive esophagitis, and Helicobacter pylori, were enrolled into two identical, multinational, multicenter double-blind studies (NASA1, SPACE1). Moreover, 608 and 556 patients were randomized to receive 4 wk esomeprazole 20 mg, or 40 mg, or placebo once daily. The primary variable was the patient-reported change in the upper GI symptom (pain, discomfort, or burning in the upper abdomen) score on a 7-graded severity scale (0-6) from the 7 days prior to treatment to the last 7 days in the study. RESULTS: Esomeprazole was associated with highly significant symptom improvement compared to placebo. Symptom improvements were 2.30 mean [SD 1.63] on esomeprazole 20 mg and 2.03 [1.56] on esomeprazole 40 mg versus 1.64 [1.57] on placebo in NASA1 and 2.17 [1.34] and 2.12 [1.48]versus 1.56 [1.26], respectively, in SPACE1 (all placebo comparisons at least p < 0.001). Esomeprazole-improved symptoms in patients taking selective COX-2 inhibitors, with changes of 2.21 [1.46] and 1.92 [1.38]versus 1.64 [1.46] in NASA1 and 2.20 [1.26] and 2.24 [1.62]versus 1.58 [1.37] in SPACE1 (all placebo comparisons at least p < 0.05), as well as those on non-selective NSAIDs. Esomeprazole was well tolerated and associated with significant improvements in HRQL. CONCLUSION: Esomeprazole 20 mg and 40 mg improve upper GI symptoms associated with continuous, daily NSAID therapy, including selective COX-2 inhibitors.

Aged↗
PubMed2005

Nonsteroidal anti-inflammatory drugs, aspirin, and gastrointestinal prophylaxis: an ounce of prevention.

Because of the widespread use of nonsteroidal anti-inflammatory drugs (NSAIDs), NSAID-related gastrointestinal (GI) complications are recognized as the most prevalent drug toxicity in the United States. The withdrawal of 2 selective cyclooxygenase-2 (COX-2) inhibitors (agents specifically developed to reduce ulcer complications) from the US market owing to adverse cardiovascular events has made reducing ulcer risk more important than ever for patients receiving NSAID treatment. In addition, the impact of aspirin, implicated by itself as a cause of serious adverse GI events and in combination with NSAIDs as a source of incremental risk, remains under-appreciated. Balancing the cardiovascular risks of selective COX-2 inhibitors with the higher GI risks associated with conventional NSAIDs remains a major clinical challenge. Gastro-protective therapy, such as with a proton pump inhibitor, is beneficial in patients receiving NSAIDs, but despite current treatment recommendations, this "ounce of prevention" remains substantially underused for patients at risk.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2004

Acute pancreatitis after EUS-guided FNA of solid pancreatic masses: a pooled analysis from EUS centers in the United States.

BACKGROUND: The aim of this study was to determine the frequency and the severity of pancreatitis after EUS-guided FNA of solid pancreatic masses. A survey of centers that offer training in EUS in the United States was conducted. METHODS: A list of centers in which training in EUS is offered was obtained from the Web site of the American Society for Gastrointestinal Endoscopy. Designated program directors were contacted via e-mail. The information requested included the number of EUS-guided FNA procedures performed for solid pancreatic masses, the number of cases of post-procedure pancreatitis, and the method for tracking complications. For each episode of pancreatitis, technical details were obtained about the procedure, including the location of the mass, the type of fine needle used, the number of needle passes, and the nature of the lesion. RESULTS: Nineteen of the 27 programs contacted returned the questionnaire (70%). In total, 4909 EUS-guided FNAs of solid pancreatic masses were performed in these 19 centers over a mean of 4 years (range 11 months to 9 years). Pancreatitis occurred after 14 (0.29%): 95% CI[0.16, 0.48] procedures. At two centers in which data on complications were prospectively collected, the frequency of acute pancreatitis was 0.64%, suggesting that the frequency of pancreatitis in the retrospective cohort (0.26%) was under-reported (p=0.22). The odds that cases of pancreatitis would be reported were 2.45 greater for the prospective compared with the retrospective cohort (95% CI[0.55, 10.98]). The median duration of hospitalization for treatment of pancreatitis was 3 days (range 1-21 days). The pancreatitis was classified as mild in 10 cases, moderate in 3, and severe in one; one death (proximate cause, pulmonary embolism) occurred after the development of pancreatitis in a patient with multiple comorbid conditions. CONCLUSIONS: EUS-guided FNA of solid pancreatic masses is infrequently associated with acute pancreatitis. The procedure appears to be safe when performed by experienced endosonographers. The frequency of post EUS-guided FNA pancreatitis may be underestimated by retrospective analysis.

Acute Disease↗
PubMed2004

A randomized, controlled comparison of ibuprofen at the maximal over-the-counter dose compared with prescription-dose celecoxib on upper gastrointestinal mucosal injury.

BACKGROUND & AIMS: Ibuprofen is a well-tolerated nonsteroidal anti-inflammatory drug (NSAID), particularly at over-the-counter (OTC) doses. Cyclooxygenase 2 (COX-2)-selective inhibitors cause less ulceration than prescription-dose nonselective NSAIDs. We compared endoscopic injury related to nonprescription ibuprofen doses with celecoxib, also comparing prescription doses of naproxen with placebo as a positive control. METHODS: The study was a randomized, placebo-controlled, double blind, double-dummy endoscopic evaluation with concealed allocation. A 2-way crossover with a 4-5-week washout period was used. Participants were healthy adults with normal baseline findings from endoscopy. Ninety-five subjects were randomly assigned, and 79 subjects completed both study phases. Age distribution was reflective of the target population of the OTC agent. Twenty percent were infected with Helicobacter pylori, and 79% and 67% had a current or past medical problem, respectively. Qualifying subjects, stratified by the presence or absence of H. pylori infection (n = 20), were randomly assigned to 1 of the 4 sequences (phase I/II) as follows: ibuprofen/celecoxib; celecoxib/ibuprofen, naproxen/placebo, or placebo/naproxen. Primary end points were the frequency of endoscopic ulcers and erosions in the groups administered: (1) celecoxib vs. ibuprofen and (2) naproxen vs. placebo. RESULTS: In celecoxib-treated subjects, 2.6% developed ulcers compared with 17.9% of those treated with ibuprofen (P = 0.056). Naproxen treatment was associated with a significantly greater ulceration rate compared with placebo. CONCLUSIONS: Short-term use of the nonselective COX inhibitors ibuprofen and naproxen is associated with a greater risk for endoscopic mucosal injury compared with the COX-2-selective inhibitor celecoxib or placebo. A prospective analysis appropriately powered to address the incidence of clinically significant gastroduodenal ulceration associated with the short-term use of these agents would be required to further define the clinical relevance of these findings.

Adolescent↗
PubMed2003

Potential effect of cyclooxygenase-2-specific inhibitors on the prevention of colorectal cancer: a cost-effectiveness analysis.

PURPOSE: To estimate the potential cost-effectiveness of colorectal cancer chemoprevention with cyclooxygenase-2-specific inhibitors (COX-2 inhibitors). METHODS: Using a decision analytic Markov model, we estimated the discounted cost per life-year saved for three strategies: a COX-2 inhibitor alone; as an adjunct to colonoscopy every 10 years in persons at average risk of colorectal cancer; and as an adjunct to colonoscopy every 5 years in persons with first-degree relatives who had colorectal cancer. RESULTS: In the base case, the incremental cost per life-year saved with a COX-2 inhibitor alone compared with no screening was 233,300 dollars in persons at average risk of colorectal cancer and 56,700 dollars in persons with 2 first-degree relatives who had the disease. Chemoprevention was both less effective and more costly than screening. The incremental cost per life-year saved with a COX-2 inhibitor as an adjunct to screening was 823,800 dollars in persons at average risk and 404,700 dollars in persons with 2 first-degree relatives who had colorectal cancer. Combining a COX-2 inhibitor with less frequent screening was not as cost-effective as screening at currently recommended intervals. Cost-effectiveness estimates were highly sensitive to the cost of COX-2 inhibitors and their effect on the risk of cancer. CONCLUSION: Chemoprevention of colorectal cancer with COX-2 inhibitors is likely to incur substantially higher costs per life-year saved than are currently recommended screening strategies. COX-2 inhibitor use as an adjunct to screening may increase life expectancy, although at prohibitive costs, and is unlikely to result in less frequent screening.

Aged↗
PubMed2003

Making cost-effectiveness analyses clinically relevant: the effect of provider expertise and biliary disease prevalence on the economic comparison of alternative diagnostic strategies.

RATIONALE AND OBJECTIVES: This study was performed to assess the incremental cost-effectiveness of initial magnetic resonance cholangiopancreatography (MRCP) and initial endoscopic ultrasonography (EUS) compared with initial endoscopic retrograde cholangiopancreatography (ERCP) and to evaluate the effect of MRCP provider expertise on the relative cost-effectiveness of the three methods. MATERIALS AND METHODS: Thirty patients with suspected biliary disease and referred for ERCP were prospectively evaluated with EUS, MRCP, or ERCP within 24 hours of referral, according to institutional review board-approved protocol. Performance characteristics were measured for EUS and MRCP, with ERCP as the reference standard. A decision analysis compared the clinical and economic effects of three diagnostic strategies (ERCP, EUS followed by ERCP [EUS-ERCP], and MRCP followed by ERCP [MRCP-ERCP]) using prospective EUS and MRCP test characteristics and Medicare reimbursements. The added costs per additional correct diagnosis and per additional false-positive finding averted and the rates and costs of ERCP-related complications were calculated for EUS-ERCP and MRCP-ERCP. Two additional MRCP readers reviewed MRCP data to evaluate interobserver variability and estimate provider expertise. Additional economic analyses incorporated these estimates. RESULTS: Compared with initial ERCP, EUS-ERCP demonstrated 72% of biliary abnormalities and reduced ERCP-related complications by 60%; the corresponding percentages for MRCP-ERCP were 48% and 40%. Initial EUS and initial MRCP decreased the number of ERCP procedures performed by 69% and 49%, respectively. Each correct diagnosis made with ERCP that would not have been made with initial EUS or initial MRCP cost an additional 4,875 dollars or 2,580 dollars, respectively. Each false-positive diagnosis averted with initial ERCP that would have been made with EUS-ERCP or MRCP-ERCP cost an additional 9,750 dollars or 1,548 dollars, respectively. The decision model was most sensitive to disease prevalence. As provider expertise increased, the additional cost of an additional correct diagnosis increased for ERCP compared with MRCP-ERCP, with disease prevalence accentuating provider effects. CONCLUSION: Initial EUS and initial MRCP are less costly than initial ERCP, but provider expertise, biliary disease prevalence, and procedural costs influence incremental cost-effectiveness.

Biliary Tract Diseases↗
PubMed2003

EUS detection of pancreatic endocrine tumors in asymptomatic patients with type 1 multiple endocrine neoplasia.

BACKGROUND: EUS is highly sensitive, specific, and cost-effective for localization of pancreatic neuroendocrine tumors. EUS screening of asymptomatic patients with multiple endocrine neoplasia type 1 has not been described. METHODS: EUS was used to evaluate all patients with known or suspected pancreatic neuroendocrine tumors. Asymptomatic patients with either a confirmed genetic or clinical diagnosis of multiple endocrine neoplasia type 1 were evaluated with EUS. The results were correlated with surgical and histopathologic findings. RESULTS: A total of 65 patients with multiple endocrine neoplasia type 1 underwent 132 EUS procedures over an 8-year period, including 13 asymptomatic patients. Five of the 13 asymptomatic patients had normal serum gastrin levels, and 8 had levels less than 4 times the upper limit of normal. EUS demonstrated pancreatic neuroendocrine tumors in 11 of these patients, ranging in size from 0.4 to 4 cm (mean 10 mm). Ten of the 11 patients with tumors at EUS underwent surgical exploration, and 23 of 28 (82%) tumors removed surgically had been identified by EUS. At a mean follow-up of 44 months, no liver or lymph node metastases were demonstrated in any patient. CONCLUSIONS: In this first cohort study of asymptomatic patients with multiple endocrine neoplasia type 1 undergoing screening EUS, pancreatic neuroendocrine tumors were identified before the development of significant biochemical test abnormalities. Aggressive early surgical treatment may improve the prognosis for these patients.

Adolescent↗
PubMed2003

Intrasphincteric botulinum toxin versus pneumatic balloon dilation for treatment of primary achalasia.

GOALS: Despite a high success rate, pneumatic dilatation for achalasia is accompanied by a significant risk of esophageal perforation. Injection of botulinum toxin (botox) into the lower esophageal sphincter (LES) can lead to improvement in symptoms with reduced risk of complications. Direct comparisons of the two techniques are needed to define their role in clinical management. STUDY: We compared pneumatic dilatation to botox for patients with achalasia using a double blind, randomized study design. Patients underwent clinical, manometric, radiographic and endoscopic evaluation to confirm primary achalasia. They were randomized to receive either 80 units of botox into the LES or Witzel balloon dilatation. Patients also received sham dilatation or injection, respectively. The patients and investigators assessing symptom response were blinded to therapy. Symptoms and esophageal function were assessed at 3 weeks, 3 months and 1 year after therapy. Treatment failure was defined as the lack of decrease in symptom grade more than 1 or recurrence of symptoms. Patients with treatment failure crossed over to the alternative treatment. RESULTS: Thirty four patients were studied, and 31 completed the trial. Of the 18 patients randomized to Witzel dilatation, 16 (89%) of 18 remained in clinical remission. Of the two patients with treatment failure, one responded to botox injection. Of the 16 patients randomized to botox, (38%) 6 of 16 remained in clinical remission. Four patients had initial failure, and 6 relapsed at a mean of 4 months after therapy. Of the nine patients who crossed over to dilatation, seven responded well, but two required surgical management of perforation. Although both treatments had excellent initial clinical improvement, patients randomized to Witzel dilatation had superior long-term success ( < 0.01). CONCLUSION: Initial therapy with Witzel dilatation is associated with better long-term outcome than a single injection of botox. Because of the risk of endoscopic perforation, botox remains a viable alternative to dilatation.

Anti-Dyskinesia Agents↗