2
ABSTRACTS FROM AROUND THE WORLD Visit CGH online at www.cghjournal.org to link to these articles and additional articles of interest. Proton Pump Inhibitors Do Not Help Control Asthma The American Lung Association Asthma Clinical Research Cen- ters. Efficacy of esomeprazole for treatment of poorly con- trolled asthma. N Engl J Med 2009;360:1487–1499. Summary. A link between gastroesophageal reflux (GER) and asthma has long been considered, and investi- gation for GER and/or empiric use of proton pump inhib- itors for severe asthmatics with reflux symptoms is often undertaken. This double-blind multicenter trial random- ized 412 patients with both inadequately controlled asthma despite inhaled corticosteroid use and minimal or no symp- toms of GER to either 40 mg of esomeprazole twice daily or placebo. Patients were followed for 24 weeks with daily asthma diaries and spirometry performed once every 4 weeks. Ambulatory pH monitoring was performed to deter- mine the presence or absence of GER. Reflux disease was self-reported in 19% of the placebo group and 10% of the treatment group. The primary outcome was the rate of episodes of poor asthma control based upon asthma diaries. No differences were detected in the number of episodes of poor asthma control between the two groups (2.3 and 2.5 per person year). There was also no treatment effect related to any outcome measurement. GER was identified by pH monitoring in 40% of these minimally symptomatic or asymptomatic patients, and its presence did not identify a subgroup that benefitted from proton pump inhibitor use. Editor’s comment. This trial demonstrated a high rate of GER among patients with asthma— 40%. Never- theless, the use of high-dose esomeprazole neither re- duced the rate of poorly controlled asthma episodes nor impacted any other measures, including respiratory func- tion and quality of life. Furthermore, the presence of GER did not identify a subgroup who responded to acid suppression as well. At least for now, it seems the pen- dulum has swung away from the reflux-asthma link. ............................................................ Protease Inhibitor Therapy Augments Standard Treatment of Hepatitis C Virus McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infec- tion. N Engl J Med 2009;360:1827–1838. Hézode C, Forestier N, Dusheiko G, et al. Telaprevir and pegin- terferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009;360:1839 –1850. Summary. Therapy for hepatitis C virus (HCV) infec- tion remains inadequate with only about half of patients infected with HCV genotype 1 achieving a sustained viro- logic response (SVR) to standard peginterferon/ribavirin therapy. Preliminary studies with telaprevir, a specific inhib- itor of the HCV serine protease, suggested virologic activity against HCV. Two parallel studies examined the efficacy of this agent involving various combinations of this agent with the current standard for therapy. In the first study, patients with HCV genotype 1 infection were randomized to 1 of 4 treatment groups: either to a control group that received peginterferon and ribavirin for 48 weeks and telaprevir- matched placebo for 12 weeks, or to 1 of 3 telaprevir groups that received telaprevir 1250 mg on the first day, followed by 750 mg every 8 hours, plus peginterferon and ribavirin at the same dose as the control group but at different dura- tions, including 12 weeks, 24 weeks, and 48 weeks. The primary outcome was SVR 24 weeks after the end of ther- apy. SRV was shown in 41% of patients in the control group, and in 35%, 61%, and 67% of patients in the 12-week, 24-week, and 48-week treatment groups, respectively. In the parallel trial by Hézode et al, the first group received telaprevir/peginterferon/ribavirin for 12 weeks followed by peginterferon/ribavirin for an additional 12 weeks; the second group received 12 weeks of each regimen alone; and the third group received 12 weeks of telaprevir and 12 weeks of peginterferon without ribavirin. The control group received peginterferon and ribavirin for 48 weeks. SVR was documented in 46% of patients in the control group compared with 36% of patients in the group re- ceiving telaprevir for 12 weeks followed by peginterferon without ribavirin for 12 weeks, 60% of patients in the group receiving telaprevir, peginterferon, and ribavirin for a total of 12 weeks, and 69% of patients in the group receiving telaprevir for 12 weeks followed by peginter- feron and ribavirin for 12 additional weeks. Side effects from telaprevir were more common and included pruri- tus and rash; 12% of patients discontinued the study treatment in the telaprevir-based groups. Editor’s comment. We have heard about protease inhibitor therapy for HCV infection for some time, but now it appears to be imminent. These data suggest that the addition of telaprevir for at least 12 weeks improves the sustained virologic response rate for standard pegin- terferon ribavirin therapy. Ribavirin was again shown to be an important component of the treatment cocktail, and the more prolonged treatment with peginterferon/ ribavirin (24 weeks) was also associated with a higher SVR. Look for many other studies of this agent and new ones yet to come to determine which agent(s) and regi- men(s) are most efficacious. The overall direction of ther- apy appears similar to those for HIV, in which multiple agents in various combinations will likely be used to enhance SVR. CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2009;7:712–713

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Page 1: Abstracts from Around the World

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CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2009;7:712–713

BSTRACTS FROM AROUND THE WORLD

Visit CGH online at www.cghjournal.org to link to these articles and additional articles of interest.

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Proton Pump Inhibitors Do Not Helpontrol Asthma

he American Lung Association Asthma Clinical Research Cen-ers. Efficacy of esomeprazole for treatment of poorly con-rolled asthma. N Engl J Med 2009;360:1487–1499.

Summary. A link between gastroesophageal refluxGER) and asthma has long been considered, and investi-ation for GER and/or empiric use of proton pump inhib-tors for severe asthmatics with reflux symptoms is oftenndertaken. This double-blind multicenter trial random-

zed 412 patients with both inadequately controlled asthmaespite inhaled corticosteroid use and minimal or no symp-oms of GER to either 40 mg of esomeprazole twice daily orlacebo. Patients were followed for 24 weeks with dailysthma diaries and spirometry performed once every 4eeks. Ambulatory pH monitoring was performed to deter-ine the presence or absence of GER. Reflux disease was

elf-reported in 19% of the placebo group and 10% of thereatment group. The primary outcome was the rate ofpisodes of poor asthma control based upon asthma diaries.o differences were detected in the number of episodes ofoor asthma control between the two groups (2.3 and 2.5er person year). There was also no treatment effect relatedo any outcome measurement. GER was identified by pH

onitoring in 40% of these minimally symptomatic orsymptomatic patients, and its presence did not identify aubgroup that benefitted from proton pump inhibitor use.

Editor’s comment. This trial demonstrated a highate of GER among patients with asthma— 40%. Never-heless, the use of high-dose esomeprazole neither re-uced the rate of poorly controlled asthma episodes nor

mpacted any other measures, including respiratory func-ion and quality of life. Furthermore, the presence ofER did not identify a subgroup who responded to acid

uppression as well. At least for now, it seems the pen-ulum has swung away from the reflux-asthma link.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Protease Inhibitor Therapy Augmentstandard Treatment of Hepatitis C ViruscHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with

eginterferon and ribavirin for chronic HCV genotype 1 infec-ion. N Engl J Med 2009;360:1827–1838.

ézode C, Forestier N, Dusheiko G, et al. Telaprevir and pegin-erferon with or without ribavirin for chronic HCV infection.

Engl J Med 2009;360:1839 –1850.

Summary. Therapy for hepatitis C virus (HCV) infec-ion remains inadequate with only about half of patients

nfected with HCV genotype 1 achieving a sustained viro- e

ogic response (SVR) to standard peginterferon/ribavirinherapy. Preliminary studies with telaprevir, a specific inhib-tor of the HCV serine protease, suggested virologic activitygainst HCV. Two parallel studies examined the efficacy ofhis agent involving various combinations of this agent withhe current standard for therapy. In the first study, patientsith HCV genotype 1 infection were randomized to 1 of 4

reatment groups: either to a control group that receivedeginterferon and ribavirin for 48 weeks and telaprevir-atched placebo for 12 weeks, or to 1 of 3 telaprevir groups

hat received telaprevir 1250 mg on the first day, followedy 750 mg every 8 hours, plus peginterferon and ribavirin athe same dose as the control group but at different dura-ions, including 12 weeks, 24 weeks, and 48 weeks. Therimary outcome was SVR 24 weeks after the end of ther-py. SRV was shown in 41% of patients in the control group,nd in 35%, 61%, and 67% of patients in the 12-week,4-week, and 48-week treatment groups, respectively. In thearallel trial by Hézode et al, the first group receivedelaprevir/peginterferon/ribavirin for 12 weeks followedy peginterferon/ribavirin for an additional 12 weeks; theecond group received 12 weeks of each regimen alone;nd the third group received 12 weeks of telaprevir and2 weeks of peginterferon without ribavirin. The controlroup received peginterferon and ribavirin for 48 weeks.VR was documented in 46% of patients in the controlroup compared with 36% of patients in the group re-eiving telaprevir for 12 weeks followed by peginterferonithout ribavirin for 12 weeks, 60% of patients in theroup receiving telaprevir, peginterferon, and ribavirinor a total of 12 weeks, and 69% of patients in the groupeceiving telaprevir for 12 weeks followed by peginter-eron and ribavirin for 12 additional weeks. Side effectsrom telaprevir were more common and included pruri-us and rash; 12% of patients discontinued the studyreatment in the telaprevir-based groups.

Editor’s comment. We have heard about proteasenhibitor therapy for HCV infection for some time, butow it appears to be imminent. These data suggest thathe addition of telaprevir for at least 12 weeks improveshe sustained virologic response rate for standard pegin-erferon ribavirin therapy. Ribavirin was again shown toe an important component of the treatment cocktail,nd the more prolonged treatment with peginterferon/ibavirin (24 weeks) was also associated with a higherVR. Look for many other studies of this agent and newnes yet to come to determine which agent(s) and regi-en(s) are most efficacious. The overall direction of ther-

py appears similar to those for HIV, in which multiplegents in various combinations will likely be used to

nhance SVR.
Page 2: Abstracts from Around the World

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Use of Blood Urea Nitrogen to Gaugeeverity of Acute Pancreatitis: Simplend Accurateu BU, Johannes RS, Sun Z, et al. Early changes in blood urea

itrogen predict mortality in acute pancreatitis. Gastroenterol-gy 2009;137:129 –135.

Summary. The importance of maintaining intravas-ular volume during the acute phase of severe pancreati-is is well established both in animal models and clini-ally. In addition, prior scoring systems have usedreatinine, blood urea nitrogen (BUN), and hemoglobinHGB) to assess prognosis. This study used a database of9 US hospitals to identify all patients with a diagnosisf acute pancreatitis by ICD-9 codes over a 3-year period.he authors specifically examined the prognostic utilityf serial measurement of BUN vs HGB in the early as-essment of acute pancreatitis. Multivariable logistic re-ression was then used. They identified 5819 cases witht least 3 BUN/HGB measurements within the first 48ours of admission. BUN levels were consistently highermong nonsurvivors than survivors during the first 48ours of hospitalization, which was not found for HGB.or every 5 mg/dL increase in BUN during the first 24ours, the odds ratio for mortality increased by 2.2%. Ofhe 6 routine laboratory tests used, BUN yielded theighest predictive value at admission and at 48 hours.

Editor’s comment. This straightforward, well-donetudy confirms the importance of BUN as a prognostic

arker in acute pancreatitis. BUN is widely available,

nexpensive, and easy to use. M

dditional Papers of Interest

Jensen DM, Marcellin P, Freilich B, et al. Re-treatmentf patients with chronic hepatitis C who do not respondo peginterferon-�2b. Ann Intern Med 2009;150:528 –40.

Fogli L, Boschi S, Patrizi P, et al. Laparoscopic chole-ystectomy without intraoperative cholangiography: au-it of long-term results. J Laparoendosc Adv Surg Tech009;19:191–193.

Marrelli D, Caruso S, Pedrazzani C, et al. CA19-9erum levels in obstructive jaundice: clinical value inenign and malignant conditions. Am J Surg 2009 Apr 16Epub ahead of print].

Zeuzem S, Gane E, Liaw Y-F, et al. Baseline character-stics and early on-treatment response predict the out-omes of 2 years of telbivudine treatment of chronicepatitis B. J Hepatol 2009;51:11–20.

DeLeve LD, Valla D-C, Garcia-Tsao G. Vascular disor-ers of the liver. Hepatology 2009;49:1729 –1764.

Khalid A, Zahid M, Finkelstein SD, et al. Pancreaticyst fluid DNA analysis in evaluating pancreatic cysts: aeport of the PANDA study. Gastrointest Endosc 2009;9:1095–1102.

Ventrucci M, Pozzato P, Cipolla A, et al. Persistentlevation of serum CA19-9 with no evidence of malignantisease. Dig Liver Dis 2009;41:357–363.

Chamberlain RS, Sakpal SV. A comprehensive reviewf single-incision laparoscopic surgery (SILS) and naturalrifice transluminal endoscopic surgery (NOTES) tech-iques for cholecystectomy. J Gastrointest Surg 2009

ay 2 [Epub ahead of print].