risedronate is effective in reducing vertebral fracture risk in patients on glucocorticoid therapy

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Introduction: Venous access is needed during conscious sedation but the method varies across hospitals. Continuously infusing fluids (IVF) are most commonly used but no clear advantage has been shown over HepLok’s (HL). Specific Aims: The present study assessed the need for IVF and compared the cost of IVF vs. HL. Methods: Outpatients undergoing routine diagnostic EGD, colonoscopy (cscop) or EGD/cscop were studied. Inpatients and interventional cases were excluded. All pts had HL placed. IVF were administered as indicated for hypotension, orthostasis or dehydration. A “spiked” bag of IVF was available in each of 7 procedure rooms to be immediately available if needed. If not used, this was wasted at the end of the day. Midazolam and fentanyl were used for conscious sedation. Current charges for IVF and HL were calculated. Charges to perform all cases with IVF were calculated and compared with actual charges to use HL with IVF prn. Results: 372 endoscopic procedures were evaluated over a 12 day period and included 251 cscop’s, 95EGD’s and 26EGD/cscop’s. 21/372 (5%) cases received IVF. Indication for IVF was hypotension in 19/21 and bradycardia and “difficult exam” in one each. 19/21 cases involved cscop. IVF was started during the procedure in 15/21 cases and in the recovery room in 6/21 cases. Calculated charges for HL were $4.13/case and $6.79/case for IVF using 500ml NS. Total charges for venous access if all cases had been with IVF would have been $2525.88. Actual charges for 372-HL with 21-IVF and 84 IVF “back-up” bags (7 12 days) were $2018.31. Cost per case was reduced by $1.36. Conclusions: HL with IVF prn is cost saving. For the 11,000 outpatient procedures performed in our lab last year, this would have saved $15,000. HL with IVF prn should be the preferred method of venous access during routine endoscopic procedures. 864 Endoscopic cryotherapy is safe and effective to control bleeding from diffuse mucosal lesions of the gastrointestinal tract Sergey V Kantsevoy 1 , Marcia R Cruz-Correa 1 , Sanjay B Jagannath 1 , Cheryl A Vaughn 1 , Pankaj J Pasricha 2 and Anthony N Kalloo 1 *. 1 Gastroenterology, The Johns Hopkins University School of Medicine, Baltimore, MD, United States; and 2 Gastroenterology, University of Texas Medical Branch, Galveston, TX, United States. Purpose: Bleeding from diffuse mucosal lesions of the gastrointestinal (GI) tract can be difficult to manage. We evaluated the safety and efficacy of endoscopic cryotherapy to treat patients with recurrent GI bleeding from diffuse mucosal vascular lesions. Methods: Patients were enrolled from June 1999 till April 2001. Inclusion criteria: actively bleeding mucosal lesions resistant to conventional endo- scopic therapy and absence of systemic coagulopathy or uncorrectable bleeding disorders. Cryotherapy was applied to affected areas until all mucosal lesions were treated. Follow-up endoscopies were performed 2– 4 weeks after the final therapeutic session. Serial measurements of hematocrit and requirements for blood transfusions were documented. Patients were considered non-responders if there was continued bleeding based on de- creasing hematocrit and requirement for blood transfusions. Results: 23 patients (11 M, 12 F, mean age 66 16 yrs) were enrolled in the study. Patients with diffuse gastric/duodenal arterio-venous malforma- tions (AVMs) (n 7), watermelon stomach (n 6), radiation-induced gastritis (n 4) and radiation-induced proctitis (n 6) had a mean of 3.6 1.6 sessions. There was no difference in the number of treatment sessions in the Responders Vs Non-responders (3.8 1.7 Vs. 3.0 1.6). The best treatment results were achieved in patients with radiation-induced proctitis with complete control of bleeding in all 6 patients (100%). Cryo- therapy was also very effective in patients with multiple AVMs (86%) and watermelon stomach (67%). The lesion most resistant to cryotherapy was radiation-induced damage to stomach and duodenum, — only 1 out of 4 (25%) patients had improvement, although all patients in this group were debilitated due to disseminated malignancy (metastatic pancreatic cancer (n 2), advanced cholangiocarcinoma (n 2)). One patient developed transient abdominal pain 24 hours following the procedure without other complications. Conclusions: Cryotherapy is a safe and effective therapeutic modality for recurrent bleeding from diffuse mucosal lesions resistant to conventional endoscopic therapy. Bleeding from radiation-induced proctitis and multiple GI AVMs are especially amenable to endoscopic cryotherapy. 865 Endoscopic findings in post-transplant patients with persistent dyspepsia Umaprasanna S Karnam, Lydia Voti, Jae Nam and Jeffrey B Raskin, FACG*. 1 Division of Gastroenterology, University of Miami School of Medicine, Miami, FL; 2 University of Miami School of Medicine, Miami, FL; 3 University of Miami School of Medicine, Miami, FL; and 4 Division of Gastroenterology, University of Miami School of Medicine, Miami, FL. Purpose: In post-transplant patients, it is common practice to do esopha- gogastroduodenoscopy in patients with persistent dyspeptic symptoms to rule out opportunistic pathogens. The purpose of this study was as follows: 1. To characterize the endoscopic findings in post-transplant patients with persistent dyspepsia 2. To evaluate for the presence of CMV infection and other etiologies in these patients Methods: Retrospective cohort study of post-transplant patients with per- sistent dyspepsia in a university based medical center. The study group of 89 post-transplant patients with persistent dyspepsia included 43 (48%) patients who had a liver transplant, 27 (30%) renal and / or pancreas, 8 (9%) cardiac and 11 (12%) had multi-visceral or small bowel or BMT. Results: Of the 89 patients, 78(87.6%) had abnormal findings on endos- copy and/or histology. 11 patients(12.4%) had normal endoscopy and normal histopathology of their gastric mucosa. . Overall, 50% of the patients had the endoscopic appearance of antral erythema and 27% had diffuse gastric erythema. The most common histological interpretation of these endoscopic findings was chronic non-specific gastritis(57%).19%of the patients had reflux esophagitis(grade I to grade IV), 2% had H.pylori associated gastric ulcers in the antrum and 2% NSAID induced antral ulcers.1 patient had a gastric bezoar inducing gastric ulcer, 2 patients graft-versus-host disease, 1 patient transplant rejection and 1 patient with Strongyloides stercoralis infection. 7% of patients had gastroparesis. Only one patient (1.1%) had CMV infection of the gastric mucosa (by immu- noperoxidase and PCR) causing ulcers in the body and antrum. Conclusions: 1. The most frequent macroscopic endoscopic finding in this study was gastric mucosal erythema with chronic non-specific gastritis found on biopsy. 2. Reflux esophagitis and gastroparesis was found in 19% and 7% of patients respectively. 3. Other conditions such as GVHD, graft rejection, Strongyloides infection and H. pylori ulcers was found in 10% of patients. 4. CMV infection of the gastric mucosa was seen in only 1% of post- transplant patients and routine endoscopy to rule out CMV infection in post-transplant patients with persistent dyspepsia is unlikely to be re- warding or cost-effective. 866 Risedronate is effective in reducing vertebral fracture risk in patients on glucocorticoid therapy Michael Keller, David M Reid, Stanley Cohen, Kathleen Bos and Stanley Wallach*. 1 San Diego, California, United States; 2 Aberdeen Royal Infirmary, Aberdeen, United Kingdom; 3 Metroplex Clinical Research Center, Dallas, Texas, United States; 4 Procter & Gamble Pharmaceuticals, Mason, Ohio, United States; and 5 American College of Nutrition, Clearwater, Florida, United States. S271 AJG – September, Suppl., 2001 Abstracts

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Page 1: Risedronate is effective in reducing vertebral fracture risk in patients on glucocorticoid therapy

Introduction: Venous access is needed during conscious sedation but themethod varies across hospitals. Continuously infusing fluids (IVF) are mostcommonly used but no clear advantage has been shown over HepLok’s(HL).Specific Aims: The present study assessed the need for IVF and comparedthe cost of IVF vs. HL.Methods: Outpatients undergoing routine diagnostic EGD, colonoscopy(cscop) or EGD/cscop were studied. Inpatients and interventional caseswere excluded. All pts had HL placed. IVF were administered as indicatedfor hypotension, orthostasis or dehydration. A “spiked” bag of IVF wasavailable in each of 7 procedure rooms to be immediately available ifneeded. If not used, this was wasted at the end of the day. Midazolam andfentanyl were used for conscious sedation. Current charges for IVF and HLwere calculated. Charges to perform all cases with IVF were calculated andcompared with actual charges to use HL with IVF prn.Results: 372 endoscopic procedures were evaluated over a 12 day periodand included 251 cscop’s, 95EGD’s and 26EGD/cscop’s. 21/372 (5%)cases received IVF. Indication for IVF was hypotension in 19/21 andbradycardia and “difficult exam” in one each. 19/21 cases involved cscop.IVF was started during the procedure in 15/21 cases and in the recoveryroom in 6/21 cases. Calculated charges for HL were $4.13/case and$6.79/case for IVF using 500ml NS. Total charges for venous access if allcases had been with IVF would have been $2525.88. Actual charges for372-HL with 21-IVF and 84 IVF “back-up” bags (7 � 12 days) were$2018.31. Cost per case was reduced by $1.36.Conclusions: HL with IVF prn is cost saving. For the 11,000 outpatientprocedures performed in our lab last year, this would have saved $15,000.HL with IVF prn should be the preferred method of venous access duringroutine endoscopic procedures.

864

Endoscopic cryotherapy is safe and effective to control bleedingfrom diffuse mucosal lesions of the gastrointestinal tractSergey V Kantsevoy1, Marcia R Cruz-Correa1, Sanjay B Jagannath1,Cheryl A Vaughn1, Pankaj J Pasricha2 and Anthony N Kalloo1*.1Gastroenterology, The Johns Hopkins University School of Medicine,Baltimore, MD, United States; and 2Gastroenterology, University ofTexas Medical Branch, Galveston, TX, United States.

Purpose: Bleeding from diffuse mucosal lesions of the gastrointestinal(GI) tract can be difficult to manage. We evaluated the safety and efficacyof endoscopic cryotherapy to treat patients with recurrent GI bleeding fromdiffuse mucosal vascular lesions.Methods: Patients were enrolled from June 1999 till April 2001. Inclusioncriteria: actively bleeding mucosal lesions resistant to conventional endo-scopic therapy and absence of systemic coagulopathy or uncorrectablebleeding disorders. Cryotherapy was applied to affected areas until allmucosal lesions were treated. Follow-up endoscopies were performed 2–4weeks after the final therapeutic session. Serial measurements of hematocritand requirements for blood transfusions were documented. Patients wereconsidered non-responders if there was continued bleeding based on de-creasing hematocrit and requirement for blood transfusions.Results: 23 patients (11 M, 12 F, mean age 66 � 16 yrs) were enrolled inthe study. Patients with diffuse gastric/duodenal arterio-venous malforma-tions (AVMs) (n � 7), watermelon stomach (n � 6), radiation-inducedgastritis (n � 4) and radiation-induced proctitis (n � 6) had a mean of3.6 � 1.6 sessions. There was no difference in the number of treatmentsessions in the Responders Vs Non-responders (3.8 � 1.7 Vs. 3.0 � 1.6).The best treatment results were achieved in patients with radiation-inducedproctitis with complete control of bleeding in all 6 patients (100%). Cryo-therapy was also very effective in patients with multiple AVMs (86%) andwatermelon stomach (67%). The lesion most resistant to cryotherapy wasradiation-induced damage to stomach and duodenum, —only 1 out of 4(25%) patients had improvement, although all patients in this group weredebilitated due to disseminated malignancy (metastatic pancreatic cancer(n � 2), advanced cholangiocarcinoma (n � 2)). One patient developed

transient abdominal pain 24 hours following the procedure without othercomplications.Conclusions: Cryotherapy is a safe and effective therapeutic modality forrecurrent bleeding from diffuse mucosal lesions resistant to conventionalendoscopic therapy. Bleeding from radiation-induced proctitis and multipleGI AVMs are especially amenable to endoscopic cryotherapy.

865

Endoscopic findings in post-transplant patients with persistentdyspepsiaUmaprasanna S Karnam, Lydia Voti, Jae Nam and Jeffrey B Raskin,FACG*. 1Division of Gastroenterology, University of Miami School ofMedicine, Miami, FL; 2University of Miami School of Medicine, Miami,FL; 3University of Miami School of Medicine, Miami, FL; and 4Divisionof Gastroenterology, University of Miami School of Medicine, Miami,FL.

Purpose: In post-transplant patients, it is common practice to do esopha-gogastroduodenoscopy in patients with persistent dyspeptic symptoms torule out opportunistic pathogens. The purpose of this study was as follows:

1. To characterize the endoscopic findings in post-transplant patients withpersistent dyspepsia

2. To evaluate for the presence of CMV infection and other etiologies inthese patients

Methods: Retrospective cohort study of post-transplant patients with per-sistent dyspepsia in a university based medical center. The study group of89 post-transplant patients with persistent dyspepsia included 43 (48%)patients who had a liver transplant, 27 (30%) renal and / or pancreas, 8 (9%)cardiac and 11 (12%) had multi-visceral or small bowel or BMT.Results: Of the 89 patients, 78(87.6%) had abnormal findings on endos-copy and/or histology. 11 patients(12.4%) had normal endoscopy andnormal histopathology of their gastric mucosa. . Overall, 50% of thepatients had the endoscopic appearance of antral erythema and 27% haddiffuse gastric erythema. The most common histological interpretation ofthese endoscopic findings was chronic non-specific gastritis(57%).19%ofthe patients had reflux esophagitis(grade I to grade IV), 2% had H.pyloriassociated gastric ulcers in the antrum and 2% NSAID induced antralulcers.1 patient had a gastric bezoar inducing gastric ulcer, 2 patientsgraft-versus-host disease, 1 patient transplant rejection and 1 patient withStrongyloides stercoralis infection. 7% of patients had gastroparesis. Onlyone patient (1.1%) had CMV infection of the gastric mucosa (by immu-noperoxidase and PCR) causing ulcers in the body and antrum.Conclusions:

1. The most frequent macroscopic endoscopic finding in this study wasgastric mucosal erythema with chronic non-specific gastritis found onbiopsy.

2. Reflux esophagitis and gastroparesis was found in 19% and 7% ofpatients respectively.

3. Other conditions such as GVHD, graft rejection, Strongyloides infectionand H. pylori ulcers was found in 10% of patients.

4. CMV infection of the gastric mucosa was seen in only 1% of post-transplant patients and routine endoscopy to rule out CMV infection inpost-transplant patients with persistent dyspepsia is unlikely to be re-warding or cost-effective.

866

Risedronate is effective in reducing vertebral fracture risk inpatients on glucocorticoid therapyMichael Keller, David M Reid, Stanley Cohen, Kathleen Bos andStanley Wallach*. 1San Diego, California, United States; 2AberdeenRoyal Infirmary, Aberdeen, United Kingdom; 3Metroplex ClinicalResearch Center, Dallas, Texas, United States; 4Procter & GamblePharmaceuticals, Mason, Ohio, United States; and 5American Collegeof Nutrition, Clearwater, Florida, United States.

S271AJG – September, Suppl., 2001 Abstracts

Page 2: Risedronate is effective in reducing vertebral fracture risk in patients on glucocorticoid therapy

Purpose: Patients who are taking chronic glucocorticoids (GC) for avariety of disease conditions can lose significant amounts of bone massvery quickly. It is estimated that this bone loss leads to fractures in 30–50%of patients. Therapies that prevent bone loss or increase bone mass mayprevent secondary osteoporosis from developing in patients on GC therapy.We have conducted a study to determine the effect of risedronate onfracture rates and spinal BMDin those patients on glucocorticoid therapy.Methods: Men and women, 18–85 years of age (n � 508) receivingglucocorticoids (�7.5 mg/day) were enrolled in two clinical studies withsimilar protocols. The prevention study enrolled patients who had been onGC therapy for 3 months or less. The treatment study enrolled patients whohad been on GC therapy for more than 6 months. All patients receivedplacebo or risedronate 2.5 or 5 mg daily for 1 year while continuing GCtherapy. Patients in the prevention study received 500 mg/day of elementalcalcium while those in the treatment study received 1000 mg of elementalcalcium and 400 IU vitamin D daily. Change in lumbar spine BMD frombaseline to 1 year was the primary efficacy endpoint.Results: At 12 months, sixteen percent of patients had new vertebralfractures in the placebo groups, compared to 7% and 5% in the 2.5 and 5mg/day risedronate-treated groups respectively. A statistically significant70% vertebral fracture risk reduction vs. placebo was observed (p � 0.01)when risedronate 5 mg/day data from the two studies were pooled. Asignificant increase in BMD at the lumbar spine (2.9%, p � 0.001), femoralneck (2.8%, p � 0.001) and femoral trochanter (2.8%, p � 0.001) com-pared to placebo was observed in the risedronate-treated (5 mg/day) groups.Adverse events were similar between placebo and risedronate-treatedgroups. Upper GI adverse events were also similar between the placebo andrisedronate-treated groups. There was a slightly higher incidence of backpain and arthralgia in risedronate-treated patients, but this did not lead tomore frequent patient discontinuation.Conclusions: Risedronate is an effective and well-tolerated therapy forreducing vertebral fracture risk in patients either initiating or on mainte-nance GC therapy.

867

Role of TGF-�1 and TGF-� type II receptor in gastric cancerJu Sung Kim, MD 1, Hee Jung Son, MD1*, Dong Il Park, MD1, SangYong Song, MD2, Won Hyeok Choe, MD1, Yun Jeong Lim, MD1, Sang-Jong Park, MD1, Jae J. Kim, MD1, Young-Ho Kim, MD1, Poong-LyulRhee, MD1, Seung Woon Paik, MD1, Jong Chul Rhee, MD1 and KyooWan Choi, MD1. 1Medicine, Samsung Medical Center, SungkyunkwanUniversity School of Medicine, Seoul, Korea; and 2Pathology, SamsungMedical Center, Sungkyunkwan University School of Medicine, Seoul,Korea.

Purpose: Transforming growth factor-beta is a potent inhibitor of epithelialcell growth. However, carcinoma cells, unlike normal cells, can escapefrom negative regulation by TGF-beta through lack of expression or mu-tation of TGF-beta receptor gene. In this study, we investigated the role ofTGF-beta 1 and TGF-beta type II receptors in the progression of gastriccancer.Methods: We analyzed TGF-beta 1 and TGF-beta type II receptor mRNAexpression semi-quantitatively, measured by comparative RT-PCR usingGAPDH, in 23 patients who underwent gastric resection for gastric cancer.We analyzed the relationship between the clinicopathologic findings andthe level of the TGF-beta 1 and TGF-beta type II receptor mRNA expres-sion in carcinoma tissues and in adjacent normal tissues of gastric cancer.Results: TGF-beta 1 and TGF-beta type II receptor mRNA were expressedin all of the carcinoma tissues and adjacent normal tissues without statis-tical difference in the level of the expression. The level of TGF-beta 1mRNA expression was higher in patients with early gastric cancer, negativelymph nodes or negative perineural invasion. There was no significantcorrelation between the level of TGF-beta 1 mRNA expression and severalparameters such as age, gender, tumor size, differentiation, Lauren’s clas-sification, and vascular invasion, there was no significant correlation be-tween the level of TGF-beta type II receptor mRNA expression and several

prognostic variables described above. There was significant correlationbetween the level of TGF-beta 1 and TGF-beta type II receptor mRNA incarcinoma tissues.Conclusions: The above data indicates that TGF-beta 1 may contribute inthe early stage of gastric carcinogenesis. Further studies are required toclarify the role of TGF-beta 1 in gastric carcinogenesis.

868

Predictive factors of short-term mortality after PEG placementNejat Kiyici, MD, Yusuf Z Tatli, MD, C. S. Pitchumoni, MD, FACG*,Hilary Hertan, MD, FACG and Edward P Norkus, Ph.D.1Gastroenterology, Our Lady of Mercy Medical Center, Bronx, NewYork, United States.

Purpose: To identify the predictive factors for short-term mortality afterPEG placement using Charlson co-morbidity index.Methods: In this prospective cohort study short-term mortality was as-sessed in 57 patients referred for PEG (percutaneous endoscopic gastros-tomy) placement. Patient demographics, admitting diagnosis, indication forPEG, DNR status and comorbid conditions were analyzed. 19 differentvariables were used to calculate Charlson co-morbidity index (CCI).Nu-tritional status was evaluated by serum albumin, total lymphocyte count,total cholesterol and weight. A standard rehabilitation medicine scale wasused to evaluate functional status of all patients. The mean pre-PEGalbumin level was 2.6�/� 0.6 (SD)g/dL and mean age was 80 �/�12(SD). Patients were followed for 6 months.Results: Dementia, CVA and ventilatory assistance were the most commonindications for PEG placement. Overall mortality at 30 days was 14 %,reaching 40 % at 6 months. Logistic regression analysis was used toexamine a theoretical model for survival at 1 and 6 months. We found thatpre-PEG albumin level less than 2.5 g/dL, COPD and a CCI more than 3predicted poor survival 6 months after PEG placement. These analysisdetermined that the likelihood of death increased by 8 % (P � 0.004) withevery 0.1 g/dL decrease in pre-PEG serum albumin less than 2.5 g/dL, and13.9 fold increased likelihood of death (P � 0.009) if the CCI was greaterthan 3 at the time of PEG. This model also examined survival at 1 monthafter PEG and found that only pre-PEG albumin level less than 2.5 g/dLwas significant predictor of poor survival. Additional independent variables(Age, sex, DNR status, functional status, pre-PEG hemoglobin, total lym-phocyte count and weight) were examined in a step-wise fashion to theregression model. None were found to have any predictive effect onsurvival.Conclusions: Serum albumin level of less than 2.5 g/dL, COPD and CCImore than 3 appear to be sensitive predictors for poor survival after PEGplacement. Our findings suggest that these predictors may be appropriateidentifiers of patients with low probability of survival following PEGplacement.

Independent variables Odds-Ratio 95% confidence interval P-value

Age 1.0 0.91–1.0 0.143Sex 0.7 0.1–4.6 0.769Pre-PEG albumin 0.08 0.01–0.45 0.004CCI 1.7 1.1–2.5 0.009COPD 26.6 1.3–549.0 0.034

869

Diagnosis of irritable bowel syndrome in managed care: missedopportunity?Kevin Knight, MD1, Keiko Higuchi, MPH1, Alisa Wilson, Ph.D.1, JohnWong, B.S.1, Chiun-Fang Chiou, Ph.D.1, Victoria Barghout, M.S.P.H.2,Feride Frech, MPH2, George Longstreth, MD3 and Joshua Ofman,MD1*. 1Pharma and Research, Zynx Health Inc., Beverly Hills, CA,United States; 2Health Economics and Outcomes Research, NovartisPharmaceutical Corporation, East Hanover, NJ, United States; and3Southern California Kaiser Permanente Medical Group, San Diego,CA, United States.

S272 Abstracts AJG – Vol. 96, No. 9, Suppl., 2001