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ABSTRACT: BACKGROUND: Data on the role of colonoscopy in hematochezia are almost exclusively derived from clinical experience in tertiary care practice. OBJECTIVE: To characterize the patient population who received colonoscopy for hematochezia in a consortium of diverse gastroenterology practices. DESIGN: Retrospective analysis. SETTING: Clinical Outcomes Research Initiative Database, 2002 to 2008. PATIENTS: Adults undergoing colonoscopy for the indication of hematochezia. MAIN OUTCOME MEASUREMENTS: Demographics, comorbidity, practice setting, adverse events, and colonoscopy procedure characteristics and findings. Age-stratified analyses and analyses of inpatient- versus outpatient-performed colonoscopies were also performed. RESULTS: A total of 966,536 colonoscopies were performed during the study period, 76,186 (7.9%) were performed for evaluation of hematochezia. The majority of patients were white non-Hispanic men younger than 60 years old who underwent colonoscopy at a community practice site (79.1%) and had a low-risk American Society of Anesthesiologists (ASA) score (81.5%), in whom colonoscopy reached the cecum (94.8%), and serious adverse events were rare. Colonoscopy findings were hemorrhoids (64.4%), diverticulosis (38.6%), and polyp or multiple polyps (38.8%). From the overall cohort, 38.3% were 60 years of age and older. The older age cohort had significantly more white non-Hispanic females, high-risk ASA scores, incomplete colonoscopies, and unplanned events. Colonoscopy findings demonstrated significantly higher rates of diverticulosis, polyp or multiple polyps, mucosal abnormality/colitis, tumor, and solitary ulcer (P < .0001). There were 3941 (5.2%) who underwent inpatient-performed colonoscopy. One third of this cohort (32.6%) was defined as having a high ASA score. LIMITATIONS: Retrospective database review. CONCLUSIONS: These results describe patient populations and characterize colonoscopy findings in individuals presenting with hematochezia primarily in a community practice setting.
Gastrointestinal endoscopy 01/2013; · 6.71 Impact Factor
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ABSTRACT: Routine second-look endoscopy in modern-era peptic ulcer bleeding (PUB) remains controversial.
To assess the effectiveness of routine second-look endoscopy in patients with PUB exhibiting high-risk stigmata after standard medical care and endoscopic therapy.
Comprehensive literature searches (1990-2011) were performed, seeking randomized trials comparing a routine with an as-needed second endoscopy.
The main outcome was rebleeding. Secondary outcomes were surgery and mortality. Subanalyses assessed the influence of study quality, rebleeding definitions, endoscopic hemostasis modality, and proton pump inhibitor (PPI) therapies. Analyses were performed with Revman 5.1. Results are shown as odds ratios (ORs) and 95% confidence intervals (CIs).
Only 4 published articles completely reporting studies and 4 abstracts (of 577 citations) were included (938 patients). Rebleeding was significantly decreased by a routine second-look endoscopy (OR 0.55; 95% CI, 0.37-0.81), as was surgery (OR 0.43; 95% CI, 0.19-0.96), but not mortality (OR 0.65; 95% CI, 0.26-1.62). Results remained robust with varying definitions of rebleeding, but not with varying endoscopic hemostasis modalities and PPI therapies; the only trial in which high-dose PPI was used did not show a benefit of a second-look endoscopy. When removing the 2 trials that included patients at highest risk of rebleeding, no significant benefit attributable to a second-look endoscopy was noted (OR 0.65; 95% CI, 0.42-1.00).
The small number of trials and patients in each of these studies.
In the absence of high-dose PPI, especially in patients at very high risk (eg, active bleeding), routine second-look endoscopy appears effective in these selected patients with PUB. However, the generalizability of these results to the era of high-dose PPI and otherwise unselected patients with high-risk stigmata is unclear.
Gastrointestinal endoscopy 06/2012; 76(2):283-92. · 6.71 Impact Factor
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ABSTRACT: Accurately classifying inflammatory bowel disease (IBD) type in pediatric patients may impact medical decision-making, direct therapy, and improve outcomes.
This was a prospective cohort study evaluating classification of IBD and patient management with use of capsule endoscopy in pediatric patients with suspected or known IBD. Treating physicians completed a questionnaire before and after capsule endoscopy (CE) assessing clinical suspicion of Crohn's disease (CD) diagnosis, patient management decisions, and perceived impact of CE findings.
Eighteen subjects [11F/7M, mean age 13.8 (± 2.5) years], 4 previously diagnosed with CD, 4 with ulcerative or indeterminate colitis (UC/IC), and 10 "suspected" to have IBD were included. Following CE, 2 of 4 (50%) UC/IC patients were reclassified as having small bowel CD. In the 4 subjects with known CD, 2 (50%) had CE evidence of more proximal small bowel mucosal disease than previously recognized. In the 10 subjects with "suspected" IBD, 8 (80%) had SB ulcerations leading to a definitive diagnosis of CD. Treating physicians reported CE helped diagnosing CD in 15 of 18 (83.3%) subjects and impacted medical decision-making in 13 of 18 (72.2%), leading to a change in medical management in 14 of 18 (77.8%).
In "suspected" pediatric IBD, CE often leads to a definitive diagnosis of CD. CE can lead to reclassification of IBD from UC/IC to CD and previously diagnosed CD patients may have a more significant burden of small bowel disease. These data may help integrate CE in evaluating IBD patients, lead to more targeted medical management changes and improve outcomes.
Digestive Diseases and Sciences 09/2011; 57(2):465-71. · 2.12 Impact Factor
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Gastrointestinal endoscopy 07/2011; 74(1):234-5. · 6.71 Impact Factor
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ABSTRACT: Capsule endoscopy (CE) retention remains a concern in patients with suspected or known Crohn's Disease (CD).
The aim of this study was to evaluate the ability of a patency capsule (PC) to establish functional patency in pediatric patients with suspected or known, symptomatic IBD.
A prospective, single center study evaluating the impact of CE on CD management used PC to qualify patients for CE. Patients excreting an intact PC, usually within 40 h of ingestion, were able to undergo standard video CE. Excretion time, structural integrity and patient safety were evaluated.
Eighteen patients (10-16 years of age; 9 male; 5 known CD, 3 indeterminate colitis, 1 ulcerative colitis, 9 suspected CD) ingested the PC. Fifteen patients excreted intact PC (mean 34.5 h), 12 patients within 40 h (range 9-60 h). Sixteen (89%) underwent subsequent CE successfully. CD was eventually diagnosed in all patients having PC transit ≥40 h, whereas CD was the diagnosis in 9/12 (75%) in those patients who passed the PC within 40 h. The mean time of passage for an intact PC was 34.7 h, the longest 60 h. There were no capsule retentions or adverse events.
The PC appears to be a useful screening tool for functional patency of the small bowel in suspected or known pediatric CD. Delayed passage of an intact PC requires careful interpretation.
Digestive Diseases and Sciences 03/2011; 56(3):860-5. · 2.12 Impact Factor
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ABSTRACT: Recent data suggest that administration of prokinetics before gastroscopy may be useful in patients with acute upper GI bleeding (UGIB). Published studies are limited in the number of subjects evaluated, and the conclusions are disparate.
To assess the evidence of administering prokinetic agents before EGD in acute UGIB.
Comprehensive literature searches from 1990 to January 2010 were performed. We selected for meta-analysis randomized trials assessing prokinetic agents in acute UGIB. The primary outcome was the need for a repeat EGD. Secondary outcomes included endoscopic visualization, blood transfusions, duration of hospitalization, and surgery. Results were reported as odds ratios (ORs) or weighted mean differences (WMDs).
From 487 citations identified, we selected 3 fully published articles and 2 abstracts assessing a total of 316 patients. Erythromycin (3 studies) and metoclopramide (2 studies) were compared with either placebo (2 studies) or no treatment (3 studies). A prokinetic agent significantly reduced the need for repeat EGD (OR 0.55; 95% CI, 0.32-0.94). The number of units of blood was not significantly altered (WMD, -0.40; 95% CI, -0.86 to 0.06) nor was hospital stay (WMD, -1.04; 95% CI, -2.83 to 0.76) or the need for surgery (OR 1.11; 95% CI, 0.27-4.67). Endoscopic visualization was not analyzed because the disparate definitions across studies did not allow for meaningful clinical inferences.
The results are limited by the small number of subjects.
Intravenous erythromycin or metoclopramide immediately before EGD in acute UGIB patients decreases the need for a repeat EGD, but does not improve other clinically relevant measurable outcomes.
Gastrointestinal endoscopy 10/2010; 72(6):1138-45. · 6.71 Impact Factor
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ABSTRACT: Peptic ulcer disease is a common cause of acute upper gastrointestinal hemorrhage. The aim of this study was to describe the endoscopic management of bleeding peptic ulcers in a large, U.S. multi-center endoscopic consortium with diverse practice settings.
Adult patients who underwent upper endoscopy (EGD) for hematemesis, melena or "suspected upper GI bleed" between January 2000 and December 2004 in the Clinical Outcomes Research Initiative (CORI) endoscopic database were screened for the finding of peptic ulcer. The ulcer stigmata, endoscopic therapy and the need for repeat EGD were compared across practice sites.
Of 12,392 patients who underwent EGD for an upper gastrointestinal bleeding indication, 3,692 (30%) had at least one peptic ulcer (clean base 59.9%; flat pigmented spot 13.4%; active bleeding 10.7%; clot 7.2%; non-bleeding visible vessel (NBVV) 6.3%). Endoscopic therapy was applied to 93% of actively bleeding ulcers and 95% of NBVV. Repeat endoscopy was required in 7.3% of patients. Ulcers treated with injection monotherapy had the highest repeat EGD rates (12.2%) compared with contact thermal monotherapy (6.1%) and combination thermal/injection therapy (7.1%) (P=0.02). Immediate hemostasis rates were 88-97% across all therapeutic modalities. There was no statistical difference in hemostasis rates across therapy nor practice types.
In this multi-center consortium, initial hemostasis rates were high across therapy types and sites studied. Injection monotherapy was associated with the highest rates of repeat EGD, supporting guidelines that advise against its use in bleeding peptic ulcers.
Digestive Diseases and Sciences 09/2010; 55(9):2568-76. · 2.12 Impact Factor
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Fasiha Kanwal,
Alan Barkun, Ian M Gralnek,
Steven M Asch,
Ernst J Kuipers,
Marc Bardou,
Joseph Sung,
Robert Enns,
Lars Agreus,
David Armstrong,
Brennan M R Spiegel
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ABSTRACT: With an increasing emphasis on quality in health care and recognition of inconsistencies in the management of patients with nonvariceal upper gastrointestinal hemorrhage (NVUGIH), it is critical to establish a set of explicit quality indicators (QIs) in NVUGIH.
We conducted a nine-member, multidisciplinary expert panel and followed modified Delphi methods to systematically identify a set of QIs for NVUGIH. The panel performed independent ratings of each candidate QI using a nine-point RAND appropriateness scale, then met in person and re-voted using an iterative process of discussion. The final set comprised QIs with a median RAND Appropriateness Score >or=7 and no disagreement among experts.
Among 116 candidate QIs, the panel rated 26 as valid measures of quality care. The selected QIs cover pre-endoscopy, endoscopy, and post-endoscopy care, including diagnosis, early resuscitation, risk stratification, endoscopic care, Helicobacter pylori management, and proton pump inhibitor therapy.
We have developed an explicit set of evidence-based QIs in NVUGIH, providing physicians and institutions with a tool to identify processes amenable to quality improvement. This tool is intended to be applicable in all institutions providing care for NVUGIH patients.
The American Journal of Gastroenterology 08/2010; 105(8):1710-8. · 7.28 Impact Factor
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ABSTRACT: Background Peptic ulcer disease is a common cause of acute upper gastrointestinal hemorrhage. The aim of this study was to describe the
endoscopic management of bleeding peptic ulcers in a large, U.S. multi-center endoscopic consortium with diverse practice
settings.
Methods Adult patients who underwent upper endoscopy (EGD) for hematemesis, melena or “suspected upper GI bleed” between January 2000
and December 2004 in the Clinical Outcomes Research Initiative (CORI) endoscopic database were screened for the finding of
peptic ulcer. The ulcer stigmata, endoscopic therapy and the need for repeat EGD were compared across practice sites.
Results Of 12,392 patients who underwent EGD for an upper gastrointestinal bleeding indication, 3,692 (30%) had at least one peptic
ulcer (clean base 59.9%; flat pigmented spot 13.4%; active bleeding 10.7%; clot 7.2%; non-bleeding visible vessel (NBVV) 6.3%).
Endoscopic therapy was applied to 93% of actively bleeding ulcers and 95% of NBVV. Repeat endoscopy was required in 7.3% of
patients. Ulcers treated with injection monotherapy had the highest repeat EGD rates (12.2%) compared with contact thermal
monotherapy (6.1%) and combination thermal/injection therapy (7.1%) (P = 0.02). Immediate hemostasis rates were 88–97% across all therapeutic modalities. There was no statistical difference in
hemostasis rates across therapy nor practice types.
Conclusion In this multi-center consortium, initial hemostasis rates were high across therapy types and sites studied. Injection monotherapy
was associated with the highest rates of repeat EGD, supporting guidelines that advise against its use in bleeding peptic
ulcers.
Digestive Diseases and Sciences - DIGEST DIS SCI. 01/2010; 55(9):2568-2576.
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ABSTRACT: It is well-established that cirrhosis negatively impacts health-related quality of life (HRQOL). However, it is less clear how to use this information in everyday clinical practice. If HRQOL predicted survival in cirrhosis, then measuring HRQOL would have important clinical implications. We sought to measure the association between HRQOL and survival in patients with cirrhosis and investigated whether the relationship between HRQOL and survival is independent of Model for End-Stage Liver Disease (MELD).
We measured HRQOL in 156 patients with cirrhosis awaiting liver transplantation by using the Short Form Liver Disease Quality of Life instrument. We followed patients prospectively and used Cox proportional hazard models to measure the independent effect of baseline HRQOL on survival, adjusting for MELD and other covariates.
During a mean 9-month follow-up, 26 (17%) patients died, and 30 (20%) received liver transplants. In unadjusted analysis, higher baseline HRQOL predicted lower mortality (hazard ratio, 0.96; 95% confidence interval, 0.94-0.99). Specifically, for each 1-point increase in HRQOL, there was a 4% decrease in mortality. These results did not change after adjusting for MELD scores, patient demographics, or psychosocial characteristics; the MELD score accounted for 1% of the variation in HRQOL scores (P = .18). Survival was most strongly predicted by activities of daily living, health distress, sleep disturbance, and perceived disease stigma.
Higher HRQOL predicts lower mortality in patients with cirrhosis. This relationship is independent of MELD; MELD does not capture liver-specific HRQOL. Beyond its use as a secondary outcome in clinical trials, HRQOL could be used to predict survival of patients with advanced liver disease.
Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association 04/2009; 7(7):793-9. · 5.64 Impact Factor
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New England Journal of Medicine 09/2008; 359(9):928-37. · 53.30 Impact Factor
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ABSTRACT: Data are sparse on the role of capsule endoscopy (CE) in classifying disease type, affecting patient management, and altering health outcomes in pediatric inflammatory bowel disease (IBD). In a retrospective cohort analysis of symptomatic pediatric patients with previously diagnosed IBD, we evaluated whether data from CE would result in the recognition of new disease locations that could alter the current diagnosis and provide information to better manage the underlying disease.
CE evaluation was performed in 28 patients an average of 4.2 +/- 3 years after original IBD diagnosis, and was prompted by exacerbation of underlying disease, growth failure/weight loss, or presurgical evaluation. Of the patients, 7 of 28 (25%) were originally diagnosed as having ulcerative colitis (UC) (n = 5) or indeterminate colitis (IC) (n = 2), while 21 of 28 (75%) were diagnosed as having Crohn disease (CD).
Following CE examination, 4 of 5 patients with UC and 1 of 2 patients with IC (total 5 of 7, 71% of UC/IC patients) had their disease reclassified to CD based upon newly diagnosed small bowel mucosal lesions. Moreover, 13 of 21 (62%) patients with CD were found at the time of CE examination to have more extensive small bowel disease with newly diagnosed jejunal disease found in 12 of 13 (92%) patients. In the 5 newly diagnosed patients with CD, all of them had therapeutic changes made. One capsule retention occurred.
Capsule endoscopy may lead to reclassification of IBD from UC/ IC to definitive CD. In addition, previously diagnosed patients with CD may be found to have a more significant burden of small bowel disease. Taken together, this information may facilitate more targeted and effective therapies and potentially lead to better patient outcomes.
Journal of pediatric gastroenterology and nutrition 08/2008; 47(1):31-6. · 2.18 Impact Factor
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ABSTRACT: The majority of studies on upper-GI hemorrhage (UGIH) to date have been based on clinical experience at academic centers. There is limited information about patients with UGIH who are evaluated by endoscopy at nonacademic settings, which comprise the majority of endoscopic practices in the United States.
The aims of this retrospective study were to use a large national endoscopy database to describe the population of patients who received an EGD for nonvariceal upper-GI hemorrhage at diverse clinical practice sites and to characterize their endoscopic diagnoses.
Between 2000 and 2004, the Clinical Outcomes Research Initiative (CORI) database received endoscopic reports from 72 diverse practice sites in the United States. All adult patients who underwent an EGD during this period at a CORI site for the indications of hematemesis, melena, or "suspected upper-GI bleed" were identified. Variceal bleeding was excluded. The nonvariceal UGIH cohort was described, and this group's endoscopic findings were characterized by the prevalence, indication, and location of an EGD (inpatient vs outpatient). A repeat EGD within a 2-week period was also evaluated.
A total of 243,427 EGDs were performed during the study period; 12,392 (4.9% of all EGDs) were performed for evaluation of hematemesis, melena, or "suspected" upper-GI bleed. Patients in this cohort were more likely to be older, men, and nonwhite compared with their nonbleeding counterparts. Melena was the most common indication for an EGD. The most common endoscopic finding was an ulcer (32.7%), followed by erosion (18.8%). A "normal" EGD was reported on 17.2% of EGDs. Among patients with ulcers, gastric ulcers were more common that duodenal ulcers (54.4% vs 37.1%), whereas clean-based ulcers comprised 52% of all ulcers. Ulcers and Mallory-Weiss tears were significantly more common on inpatient procedures. Ulcers identified on outpatient EGDs were more likely to be clean based. A repeat endoscopy was performed on 4% of the cohort within a 2-week follow-up period, hematemesis was the most common indication for a repeat EGD, and 24.3% of the cohort had a documented therapeutic intervention on their initial EGD. Among inpatients, 6.0% had a repeat EGD within two weeks for an UGIH indication compared with only 1.4% of outpatients (P < .0001).
These results allow association of EGD findings with patient presentation. Furthermore, it allows us to characterize endoscopic findings in a particular patient population (those patients with UGIH) in clinical practice, outside of traditional academic medical centers. The CORI database is a valuable resource for characterizing the epidemiology of endoscopic findings and, in particular, patient populations and across diverse practice settings, thus, enabling the development of hypotheses for future studies.
Gastrointestinal Endoscopy 04/2008; 67(3):422-9. · 4.88 Impact Factor
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Gastrointestinal Endoscopy - GASTROINTEST ENDOSCOP. 01/2008; 67(5).
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Ian M Gralnek
Gastrointestinal Endoscopy 01/2007; 64(6 Suppl):S16-8. · 4.88 Impact Factor
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ABSTRACT: There are limited data comparing the effectiveness of available proton pump inhibitors (PPIs) in erosive esophagitis (EE). We performed a meta-analysis to calculate the pooled effect of esomeprazole on healing rates, symptom relief, and adverse events versus competing PPIs in EE.
We performed a structured electronic search of MEDLINE and EMBASE and reviewed published abstracts to identify English-language, randomized clinical trials from 1995-2005, comparing rates of endoscopic healing, symptom relief, and adverse events with esomeprazole versus alternative PPIs in the treatment of gastroesophageal reflux disease (GERD)/EE. We then performed meta-analysis to compare the relative risk (RR) of EE healing, symptom relief, and adverse events between study arms and calculated the absolute risk reduction and number needed to treat (NNT) for each outcome.
Meta-analysis was performed on 10 studies (n=15,316). At 8 weeks, there was a 5% (RR, 1.05; 95% confidence interval, 1.02-1.08) relative increase in the probability of healing of EE with esomeprazole, yielding an absolute risk reduction of 4% and NNT of 25. The calculated NNTs by Los Angeles grade of EE (grades A-D) were 50, 33, 14, and 8, respectively. Last, esomeprazole conferred an 8% (RR, 1.08; 95% confidence interval, 1.05-1.11) relative increase in the probability of GERD symptom relief at 4 weeks.
As compared with other PPIs, esomeprazole confers a statistically significant improvement, yet, clinically, only a modest overall benefit in 8-week healing and symptom relief in all-comers with EE. The clinical benefit of esomeprazole appears negligible in less severe erosive disease but might be important in more severe disease.
Clinical Gastroenterology and Hepatology 01/2007; 4(12):1452-8. · 5.63 Impact Factor
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ABSTRACT: Over the last 20 years, endoscopic hemostasis has become the primary method of controlling acute, overt upper gastrointestinal hemorrhage (UGIH) and prevent rebleeding. Although uncommon, procedure-related complications may occur. This article reviews the risks attributable to endoscopic hemostasis in acute UGIH and how to help prevent these complications.
Gastrointestinal Endoscopy Clinics of North America 01/2007; 17(1):157-67, viii.
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ABSTRACT: Hepatitis B virus (HBV) patients with cirrhosis are at risk for developing costly, morbid, or mortal events, and therefore need highly effective therapies. Lamivudine is effective but is limited by viral resistance. In contrast, adefovir and entecavir have lower viral resistance, but are more expensive. The most cost-effective approach is uncertain.
We evaluated the cost-effectiveness of six strategies in HBV cirrhosis: (1) No HBV treatment ("do nothing"), (2) lamivudine monotherapy, (3) adefovir monotherapy, (4) lamivudine with crossover to adefovir on resistance ("adefovir salvage"), (5) entecavir monotherapy, or (6) lamivudine with crossover to entecavir on resistance ("entecavir salvage"). The primary outcome was the incremental cost per quality-adjusted life-year (QALY) gained.
The "do nothing" strategy was least effective yet least expensive. Compared with "do nothing," using adefovir cost an incremental US dollars 19,731. Entecavir was more effective yet more expensive than adefovir, and cost an incremental US dollars 25,626 per QALY gained versus adefovir. Selecting between entecavir versus adefovir was highly dependent on the third-party payer's "willingess-to-pay" (e.g., 45% and 60% of patients fall within budget if willing-to-pay US dollars 10K and US dollars 50K per QALY gained for entecavir, respectively). Both lamivudine monotherapy and the "salvage" strategies were not cost-effective. However, between the two salvage strategies, "adefovir salvage" was more effective and less expensive than "entecavir salvage."
Both entecavir and adefovir are cost-effective in patients with HBV cirrhosis. Choosing between adefovir and entecavir is highly dependent on available budgets. In patients with HBV cirrhosis with previous lamivudine resistance, "adefovir salvage" appears more effective and less expensive than "entecavir salvage."
The American Journal of Gastroenterology 10/2006; 101(9):2076-89. · 7.28 Impact Factor
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ABSTRACT: The most cost-effective route of administering proton pump inhibitor (PPI) therapy in peptic ulcer hemorrhage remains uncertain. Oral (PO) PPI therapy may be less effective than intravenous (IV) PPI therapy, but is less expensive and does not mandate a 72-hour posthemostasis hospital stay to complete a full therapeutic course. Because there are currently no published head-to-head clinical trials comparing IV vs PO PPIs, we used decision analysis with budget impact modeling to measure the clinical and economic outcomes of these competing modes of administration.
We compared 3 postendoscopic strategies for high-risk peptic ulcer hemorrhage: (1) PO PPI therapy, (2) IV PPI therapy, and (3) IV histamine(2) receptor antagonist therapy. The primary outcomes were cost per quality-adjusted life-year gained, and per-member per-month cost in a hypothetical managed care organization with 1,000,000 covered lives.
Compared with the PPI strategies, the histamine(2) receptor antagonist strategy was more expensive and less effective. Of the 2 PPI strategies, using IV instead of PO PPI cost an incremental 708,735 US dollars per year to gain 1 additional quality-adjusted life-year. Substituting IV in lieu of PO PPI cost each member 2.86 US dollars per month to subsidize. The IV PPI strategy became dominant when the rebleed rate with PO PPIs exceeded 24% (base case = 13%), and when the hospital stay on IV PPIs decreased to less than 72 hours.
The higher effectiveness of IV PPI therapy may not offset its increased costs vs PO PPI therapy in ulcer hemorrhage. The managed care budget impact of IV PPIs exceeds most benchmarks.
Clinical Gastroenterology and Hepatology 08/2006; 4(8):988-997. · 5.63 Impact Factor
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ABSTRACT: Because dyspeptic symptoms are far more prevalent than ulcer complications in users of nonsteroidal anti-inflammatory drugs (NSAIDs), economic models indicate that dyspepsia rates (not ulcer complications) are the major determinant of cost-effectiveness in treating arthritis. We performed a meta-analysis to compare rates of dyspepsia for two common therapies in high-risk patients with arthritis: cyclooxygenase-2 inhibitor (Coxib) alone and combination therapy with a nonselective NSAID and a proton pump inhibitor (PPI) (NSAID+PPI).
We performed a systematic review to identify trials comparing either a Coxib versus NSAID or NSAID+PPI versus NSAID in chronic arthritis. We selected studies that report incident dyspepsia, defined a priori as "epigastric pain," "dyspepsia," and "nausea." We then performed meta-analysis to compare the relative risk reduction and absolute risk reduction of dyspepsia for Coxib versus NSAID and NSAID+PPI versus NSAID.
Meta-analysis of 26 studies comparing dyspepsia between Coxibs and NSAIDs revealed a 12% relative risk reduction for Coxibs with an absolute risk reduction of 3.7%. Meta-analysis of four studies comparing dyspepsia between the NSAID+PPI combination and NSAIDs alone revealed a 66% relative risk reduction for NSAID+PPI with an absolute risk reduction of 9%. Compared with the NSAID strategy, the number needed to treat to prevent dyspepsia was 27 for Coxibs and 11 for NSAID+PPI.
NSAID+PPI affords greater risk reduction for dyspepsia than Coxibs when compared with the common baseline of NSAIDs. Because there are limited head-to-head data comparing Coxibs versus NSAID+PPI, these data provide the best indirect evidence that NSAID+PPI may be superior to Coxibs in minimizing incident dyspepsia.
The American journal of medicine 06/2006; 119(5):448.e27-36. · 4.47 Impact Factor
