Kathleen Louden

CHICAGO — A community screening and treatment program for Helicobacter pylori infection significantly reduced the use of dyspepsia-related health resources, Alexander Ford, M.B., reported at the annual Digestive Disease Week.

Antimicrobial eradication therapy for H. pylori yielded a 10-year mean savings in total dyspepsia-related costs of $117 per treated individual, said Dr. Ford, of Leeds (England) General Infirmary.

The savings, mainly due to reduced prescriptions for dyspepsia, were greater than the cost of the screening, according to Dr. Ford. The reductions in total dyspepsia-related health care costs and dyspepsia-related prescribing costs were both statistically significant.

“This could be the first screening study to pay for itself,” he commented.

Study subjects were H. pylori-positive individuals who had participated in a community screening program (conducted by the Leeds HELP study group, Lancet 2000;355:1665–9) and who returned a recent dyspepsia questionnaire and consented to have their medical records examined. Of these 914 participants, 474 had originally been randomized to eradication therapy consisting of omeprazole, clarithromycin, and tinidazole for 7 days; 440 had been randomized to receive placebo.

The findings lend support to eradication therapy for H. pylori-positive individuals who have nonulcer dyspepsia, an approach for which Dr. Ford said there has been conflicting evidence.

In the United Kingdom, physicians give H. pylori eradication therapy in dyspeptic patients, he said in an interview. However, in the United States, the National Institutes of Health does not recommend eradication therapy for persons who have nonulcer dyspepsia or are asymptomatic, according to a 1994 consensus statement.

In the current study, eradication therapy was associated with a reduction in dyspepsia symptoms that was not statistically significant. Of the subjects who had dyspepsia symptoms at baseline, 59% of the treated group remained symptomatic at 10 years vs. 66% who received placebo, Dr. Ford said in an interview.

There was a possible selection bias in locating original participants of the screening program.

“We were more likely to contact people of higher socioeconomic status, and they were more likely to respond,” Dr. Ford said.

CHICAGO — A community screening and treatment program for Helicobacter pylori infection significantly reduced the use of dyspepsia-related health resources, Alexander Ford, M.B., reported at the annual Digestive Disease Week.

Antimicrobial eradication therapy for H. pylori yielded a 10-year mean savings in total dyspepsia-related costs of $117 per treated individual, said Dr. Ford, of Leeds (England) General Infirmary.

The savings, mainly due to reduced prescriptions for dyspepsia, were greater than the cost of the screening, according to Dr. Ford. The reductions in total dyspepsia-related health care costs and dyspepsia-related prescribing costs were both statistically significant.

“This could be the first screening study to pay for itself,” he commented.

Study subjects were H. pylori-positive individuals who had participated in a community screening program (conducted by the Leeds HELP study group, Lancet 2000;355:1665–9) and who returned a recent dyspepsia questionnaire and consented to have their medical records examined. Of these 914 participants, 474 had originally been randomized to eradication therapy consisting of omeprazole, clarithromycin, and tinidazole for 7 days; 440 had been randomized to receive placebo.

The findings lend support to eradication therapy for H. pylori-positive individuals who have nonulcer dyspepsia, an approach for which Dr. Ford said there has been conflicting evidence.

In the United Kingdom, physicians give H. pylori eradication therapy in dyspeptic patients, he said in an interview. However, in the United States, the National Institutes of Health does not recommend eradication therapy for persons who have nonulcer dyspepsia or are asymptomatic, according to a 1994 consensus statement.

In the current study, eradication therapy was associated with a reduction in dyspepsia symptoms that was not statistically significant. Of the subjects who had dyspepsia symptoms at baseline, 59% of the treated group remained symptomatic at 10 years vs. 66% who received placebo, Dr. Ford said in an interview.

There was a possible selection bias in locating original participants of the screening program.

“We were more likely to contact people of higher socioeconomic status, and they were more likely to respond,” Dr. Ford said.

CHICAGO — A community screening and treatment program for Helicobacter pylori infection significantly reduced the use of dyspepsia-related health resources, Alexander Ford, M.B., reported at the annual Digestive Disease Week.

Antimicrobial eradication therapy for H. pylori yielded a 10-year mean savings in total dyspepsia-related costs of $117 per treated individual, said Dr. Ford, of Leeds (England) General Infirmary.

The savings, mainly due to reduced prescriptions for dyspepsia, were greater than the cost of the screening, according to Dr. Ford. The reductions in total dyspepsia-related health care costs and dyspepsia-related prescribing costs were both statistically significant.

“This could be the first screening study to pay for itself,” he commented.

Study subjects were H. pylori-positive individuals who had participated in a community screening program (conducted by the Leeds HELP study group, Lancet 2000;355:1665–9) and who returned a recent dyspepsia questionnaire and consented to have their medical records examined. Of these 914 participants, 474 had originally been randomized to eradication therapy consisting of omeprazole, clarithromycin, and tinidazole for 7 days; 440 had been randomized to receive placebo.

The findings lend support to eradication therapy for H. pylori-positive individuals who have nonulcer dyspepsia, an approach for which Dr. Ford said there has been conflicting evidence.

In the United Kingdom, physicians give H. pylori eradication therapy in dyspeptic patients, he said in an interview. However, in the United States, the National Institutes of Health does not recommend eradication therapy for persons who have nonulcer dyspepsia or are asymptomatic, according to a 1994 consensus statement.

In the current study, eradication therapy was associated with a reduction in dyspepsia symptoms that was not statistically significant. Of the subjects who had dyspepsia symptoms at baseline, 59% of the treated group remained symptomatic at 10 years vs. 66% who received placebo, Dr. Ford said in an interview.

There was a possible selection bias in locating original participants of the screening program.

“We were more likely to contact people of higher socioeconomic status, and they were more likely to respond,” Dr. Ford said.

CHICAGO — Active ulcerative colitis responds to the drug infliximab, according to results of two multicenter phase III trials reported at the annual Digestive Disease Week.

Active Colitis Trial (ACT) 1 and ACT 2 each enrolled 364 patients with moderate or severe ulcerative colitis, refractory to at least one standard therapy.

Investigators randomized patients to receive infliximab at a 5 mg/kg dosage, a 10 mg/kg dosage, or placebo at baseline and at weeks 2 and 6, and then every 8 weeks through week 46.

After 8 weeks of infliximab therapy at either dosage, more than 60% of patients in each trial demonstrated improvement in their symptoms vs. approximately 29% and 37% of placebo-treated patients in ACT 1 and 2, respectively, the authors reported. At 30 weeks, the clinical response was still significantly better in the infliximab groups.

Infliximab also effectively induced remission and led to mucosal healing in patients with active ulcerative colitis, both studies showed.

“This is very encouraging news for a patient population that has few treatment options,” said William Sandborn, M.D., principal investigator of ACT 2 and head of the Mayo Clinic College of Medicine's irritable bowel disease interest group and clinical research unit.

Both ACT 1 and 2 trials had similar results and patient populations, according to Dr. Sandborn, whose institution was one of 55 study centers. He described subjects as outpatients with relatively stable disease.

Several differences between the studies existed, however. At enrollment, ACT 1 patients had not responded to treatment with corticosteroids and/or immunosuppressive therapy, whereas patients in ACT 2 had experienced treatment failure with 5-aminosalicylates, steroids, and/or immunosuppressives. The duration of ACT 1 also was longer (54 vs. 30 weeks).

Clinical response was defined as a decrease in the Mayo score of at least 30% and 3 or more points, plus either a reduction of 1 or more points in the rectal bleeding score or a score of 0 or 1 at week 8.

In addition to clinical response, both trials studied clinical remission—a Mayo score of 2 or less, with no individual subscores greater than 1—and mucosal healing, characterized as an endoscopy subscore of 0 or 1.

Remission rates for the drug-treated patients were as high as 39% in ACT 1 (5 mg/kg) at week 8, compared with 15% for placebo. In ACT 1, the difference in the patients' 8-week remission rates between the 10 mg/kg infliximab dosage (32%) and placebo was highly statistically significant, said that trial's lead investigator, Paul Rutgeerts, M.D., from the University Hospital, Leuven, Belgium. Dr. Rutgeerts is a grant recipient of Centocor, the manufacturer of infliximab (Remicade).

Significant differences in remission rates between infliximab and placebo also were evident in ACT 2 and continued at 30 weeks in both trials.

Mucosal healing occurred at week 30 in a higher percentage of patients receiving 10 mg/kg of infliximab than in those with the smaller dosage (50% vs. 49% in ACT 1; 57% vs. 46% in ACT 2). Healing rates for both dosages were significantly higher than for placebo (25% in ACT 1; 30% in ACT 2).

In each study, the proportion of patients who were in remission and able to stop use of corticosteroids after 30 weeks of infliximab therapy was significantly greater for both dosages, compared with placebo.

Adverse effects seen in ACT 2 patients receiving infliximab included five cases of pneumonia and one case each of tuberculosis, optic neuritis, multifocal neuropathy, and lupus-like syndrome, Dr. Sandborn reported.

Dr. Sandborn is also a grant recipient of Centocor.

CHICAGO — Active ulcerative colitis responds to the drug infliximab, according to results of two multicenter phase III trials reported at the annual Digestive Disease Week.

Active Colitis Trial (ACT) 1 and ACT 2 each enrolled 364 patients with moderate or severe ulcerative colitis, refractory to at least one standard therapy.

Investigators randomized patients to receive infliximab at a 5 mg/kg dosage, a 10 mg/kg dosage, or placebo at baseline and at weeks 2 and 6, and then every 8 weeks through week 46.

After 8 weeks of infliximab therapy at either dosage, more than 60% of patients in each trial demonstrated improvement in their symptoms vs. approximately 29% and 37% of placebo-treated patients in ACT 1 and 2, respectively, the authors reported. At 30 weeks, the clinical response was still significantly better in the infliximab groups.

Infliximab also effectively induced remission and led to mucosal healing in patients with active ulcerative colitis, both studies showed.

“This is very encouraging news for a patient population that has few treatment options,” said William Sandborn, M.D., principal investigator of ACT 2 and head of the Mayo Clinic College of Medicine's irritable bowel disease interest group and clinical research unit.

Both ACT 1 and 2 trials had similar results and patient populations, according to Dr. Sandborn, whose institution was one of 55 study centers. He described subjects as outpatients with relatively stable disease.

Several differences between the studies existed, however. At enrollment, ACT 1 patients had not responded to treatment with corticosteroids and/or immunosuppressive therapy, whereas patients in ACT 2 had experienced treatment failure with 5-aminosalicylates, steroids, and/or immunosuppressives. The duration of ACT 1 also was longer (54 vs. 30 weeks).

Clinical response was defined as a decrease in the Mayo score of at least 30% and 3 or more points, plus either a reduction of 1 or more points in the rectal bleeding score or a score of 0 or 1 at week 8.

In addition to clinical response, both trials studied clinical remission—a Mayo score of 2 or less, with no individual subscores greater than 1—and mucosal healing, characterized as an endoscopy subscore of 0 or 1.

Remission rates for the drug-treated patients were as high as 39% in ACT 1 (5 mg/kg) at week 8, compared with 15% for placebo. In ACT 1, the difference in the patients' 8-week remission rates between the 10 mg/kg infliximab dosage (32%) and placebo was highly statistically significant, said that trial's lead investigator, Paul Rutgeerts, M.D., from the University Hospital, Leuven, Belgium. Dr. Rutgeerts is a grant recipient of Centocor, the manufacturer of infliximab (Remicade).

Significant differences in remission rates between infliximab and placebo also were evident in ACT 2 and continued at 30 weeks in both trials.

Mucosal healing occurred at week 30 in a higher percentage of patients receiving 10 mg/kg of infliximab than in those with the smaller dosage (50% vs. 49% in ACT 1; 57% vs. 46% in ACT 2). Healing rates for both dosages were significantly higher than for placebo (25% in ACT 1; 30% in ACT 2).

In each study, the proportion of patients who were in remission and able to stop use of corticosteroids after 30 weeks of infliximab therapy was significantly greater for both dosages, compared with placebo.

Adverse effects seen in ACT 2 patients receiving infliximab included five cases of pneumonia and one case each of tuberculosis, optic neuritis, multifocal neuropathy, and lupus-like syndrome, Dr. Sandborn reported.

Dr. Sandborn is also a grant recipient of Centocor.

CHICAGO — Active ulcerative colitis responds to the drug infliximab, according to results of two multicenter phase III trials reported at the annual Digestive Disease Week.

Active Colitis Trial (ACT) 1 and ACT 2 each enrolled 364 patients with moderate or severe ulcerative colitis, refractory to at least one standard therapy.

Investigators randomized patients to receive infliximab at a 5 mg/kg dosage, a 10 mg/kg dosage, or placebo at baseline and at weeks 2 and 6, and then every 8 weeks through week 46.

After 8 weeks of infliximab therapy at either dosage, more than 60% of patients in each trial demonstrated improvement in their symptoms vs. approximately 29% and 37% of placebo-treated patients in ACT 1 and 2, respectively, the authors reported. At 30 weeks, the clinical response was still significantly better in the infliximab groups.

Infliximab also effectively induced remission and led to mucosal healing in patients with active ulcerative colitis, both studies showed.

“This is very encouraging news for a patient population that has few treatment options,” said William Sandborn, M.D., principal investigator of ACT 2 and head of the Mayo Clinic College of Medicine's irritable bowel disease interest group and clinical research unit.

Both ACT 1 and 2 trials had similar results and patient populations, according to Dr. Sandborn, whose institution was one of 55 study centers. He described subjects as outpatients with relatively stable disease.

Several differences between the studies existed, however. At enrollment, ACT 1 patients had not responded to treatment with corticosteroids and/or immunosuppressive therapy, whereas patients in ACT 2 had experienced treatment failure with 5-aminosalicylates, steroids, and/or immunosuppressives. The duration of ACT 1 also was longer (54 vs. 30 weeks).

Clinical response was defined as a decrease in the Mayo score of at least 30% and 3 or more points, plus either a reduction of 1 or more points in the rectal bleeding score or a score of 0 or 1 at week 8.

In addition to clinical response, both trials studied clinical remission—a Mayo score of 2 or less, with no individual subscores greater than 1—and mucosal healing, characterized as an endoscopy subscore of 0 or 1.

Remission rates for the drug-treated patients were as high as 39% in ACT 1 (5 mg/kg) at week 8, compared with 15% for placebo. In ACT 1, the difference in the patients' 8-week remission rates between the 10 mg/kg infliximab dosage (32%) and placebo was highly statistically significant, said that trial's lead investigator, Paul Rutgeerts, M.D., from the University Hospital, Leuven, Belgium. Dr. Rutgeerts is a grant recipient of Centocor, the manufacturer of infliximab (Remicade).

Significant differences in remission rates between infliximab and placebo also were evident in ACT 2 and continued at 30 weeks in both trials.

Mucosal healing occurred at week 30 in a higher percentage of patients receiving 10 mg/kg of infliximab than in those with the smaller dosage (50% vs. 49% in ACT 1; 57% vs. 46% in ACT 2). Healing rates for both dosages were significantly higher than for placebo (25% in ACT 1; 30% in ACT 2).

In each study, the proportion of patients who were in remission and able to stop use of corticosteroids after 30 weeks of infliximab therapy was significantly greater for both dosages, compared with placebo.

Adverse effects seen in ACT 2 patients receiving infliximab included five cases of pneumonia and one case each of tuberculosis, optic neuritis, multifocal neuropathy, and lupus-like syndrome, Dr. Sandborn reported.

Dr. Sandborn is also a grant recipient of Centocor.

CHICAGO — Video capsule endoscopy appears to equal duodenal histology in detecting villous atrophy and should be used for first-line evaluation of refractory celiac disease, investigators reported at the annual Digestive Disease Week.

Two multicenter trials showed preliminary results with the new PillCam SB capsule endoscope, a pill-sized disposable camera that patients swallow and within 24 hours pass naturally.

The technique allows noninvasive examination of the entire length of the small intestine, according to Dr. med. Norbert Krauss, of Friedrich-Alexander University Hospital, Erlangen-Nuremberg, Germany.

His study, a prospective, blinded European trial, compared video capsule endoscopy with the gold standard—upper-GI endoscopy and duodenal biopsies—in 60 patients with diagnosed celiac disease.

The other study, directed by Roberto de Franchis, M.D., from the University of Milan (Italy), compared capsule endoscopy with upper GI endoscopy in 25 patients suspected of having the gluten-sensitive enteropathy.

In the first pilot study, the patients either had persistent symptoms despite more than a year of a strict gluten-free diet (44 patients) or were newly diagnosed and were not yet on a gluten-free diet (16 controls).

A dietitian verified that patients had complied with the gluten-free diet.

Two blinded reviewers interpreted the available results for 43 of the 44 patients.

Dr. Krauss said he and his colleagues found a good correlation between the two imaging techniques in both groups.

With video capsule endoscopy, all untreated controls showed typical villous atrophy and mucosal alterations, which involved the whole small intestine in three controls.

Of the 43 patients, 34 had mucosal alterations evident on the video, 2 of whom had the entire small intestine affected.

During the video recording, two patients did not show a sufficient view and in the other, the capsule did not reach the duodenum.

In addition, the new device detected ulcers in 23% of the patients with celiac disease.

“We saw many more pathologies with capsule endoscopy,” Dr. Krauss said. “I think capsule endoscopy is very important in those patients who have symptoms on a gluten-free diet.”

Dr. de Franchis reported that the aim of his study was to evaluate the potential of video capsule endoscopy, compared with conventional upper endoscopy, in detecting villous atrophy in patients with suspected celiac disease.

Whereas the conventional method showed villous atrophy in 18 of the 25 patients, capsule endoscopy found the abnormality in those plus an additional patient, he said.

The sensitivity and specificity of capsule endoscopy were 95% and 86%, respectively. Dr. de Franchis reported that the investigators did not use capsule endoscopy to test for conditions similar to celiac disease.

“PillCam endoscopy appears to be equivalent to duodenal histology in determination of villous atrophy in patients with celiac disease,” Dr. de Franchis said.

Dr. Krauss added that video capsule endoscopy should be used as the first-line evaluation in patients with confirmed celiac disease that have proved to be nonresponsive to a gluten-free diet, to exclude lymphoma, and to delineate the expansion of mucosal alterations.

CHICAGO — Video capsule endoscopy appears to equal duodenal histology in detecting villous atrophy and should be used for first-line evaluation of refractory celiac disease, investigators reported at the annual Digestive Disease Week.

Two multicenter trials showed preliminary results with the new PillCam SB capsule endoscope, a pill-sized disposable camera that patients swallow and within 24 hours pass naturally.

The technique allows noninvasive examination of the entire length of the small intestine, according to Dr. med. Norbert Krauss, of Friedrich-Alexander University Hospital, Erlangen-Nuremberg, Germany.

His study, a prospective, blinded European trial, compared video capsule endoscopy with the gold standard—upper-GI endoscopy and duodenal biopsies—in 60 patients with diagnosed celiac disease.

The other study, directed by Roberto de Franchis, M.D., from the University of Milan (Italy), compared capsule endoscopy with upper GI endoscopy in 25 patients suspected of having the gluten-sensitive enteropathy.

In the first pilot study, the patients either had persistent symptoms despite more than a year of a strict gluten-free diet (44 patients) or were newly diagnosed and were not yet on a gluten-free diet (16 controls).

A dietitian verified that patients had complied with the gluten-free diet.

Two blinded reviewers interpreted the available results for 43 of the 44 patients.

Dr. Krauss said he and his colleagues found a good correlation between the two imaging techniques in both groups.

With video capsule endoscopy, all untreated controls showed typical villous atrophy and mucosal alterations, which involved the whole small intestine in three controls.

Of the 43 patients, 34 had mucosal alterations evident on the video, 2 of whom had the entire small intestine affected.

During the video recording, two patients did not show a sufficient view and in the other, the capsule did not reach the duodenum.

In addition, the new device detected ulcers in 23% of the patients with celiac disease.

“We saw many more pathologies with capsule endoscopy,” Dr. Krauss said. “I think capsule endoscopy is very important in those patients who have symptoms on a gluten-free diet.”

Dr. de Franchis reported that the aim of his study was to evaluate the potential of video capsule endoscopy, compared with conventional upper endoscopy, in detecting villous atrophy in patients with suspected celiac disease.

Whereas the conventional method showed villous atrophy in 18 of the 25 patients, capsule endoscopy found the abnormality in those plus an additional patient, he said.

The sensitivity and specificity of capsule endoscopy were 95% and 86%, respectively. Dr. de Franchis reported that the investigators did not use capsule endoscopy to test for conditions similar to celiac disease.

“PillCam endoscopy appears to be equivalent to duodenal histology in determination of villous atrophy in patients with celiac disease,” Dr. de Franchis said.

Dr. Krauss added that video capsule endoscopy should be used as the first-line evaluation in patients with confirmed celiac disease that have proved to be nonresponsive to a gluten-free diet, to exclude lymphoma, and to delineate the expansion of mucosal alterations.

CHICAGO — Video capsule endoscopy appears to equal duodenal histology in detecting villous atrophy and should be used for first-line evaluation of refractory celiac disease, investigators reported at the annual Digestive Disease Week.

Two multicenter trials showed preliminary results with the new PillCam SB capsule endoscope, a pill-sized disposable camera that patients swallow and within 24 hours pass naturally.

The technique allows noninvasive examination of the entire length of the small intestine, according to Dr. med. Norbert Krauss, of Friedrich-Alexander University Hospital, Erlangen-Nuremberg, Germany.

His study, a prospective, blinded European trial, compared video capsule endoscopy with the gold standard—upper-GI endoscopy and duodenal biopsies—in 60 patients with diagnosed celiac disease.

The other study, directed by Roberto de Franchis, M.D., from the University of Milan (Italy), compared capsule endoscopy with upper GI endoscopy in 25 patients suspected of having the gluten-sensitive enteropathy.

In the first pilot study, the patients either had persistent symptoms despite more than a year of a strict gluten-free diet (44 patients) or were newly diagnosed and were not yet on a gluten-free diet (16 controls).

A dietitian verified that patients had complied with the gluten-free diet.

Two blinded reviewers interpreted the available results for 43 of the 44 patients.

Dr. Krauss said he and his colleagues found a good correlation between the two imaging techniques in both groups.

With video capsule endoscopy, all untreated controls showed typical villous atrophy and mucosal alterations, which involved the whole small intestine in three controls.

Of the 43 patients, 34 had mucosal alterations evident on the video, 2 of whom had the entire small intestine affected.

During the video recording, two patients did not show a sufficient view and in the other, the capsule did not reach the duodenum.

In addition, the new device detected ulcers in 23% of the patients with celiac disease.

“We saw many more pathologies with capsule endoscopy,” Dr. Krauss said. “I think capsule endoscopy is very important in those patients who have symptoms on a gluten-free diet.”

Dr. de Franchis reported that the aim of his study was to evaluate the potential of video capsule endoscopy, compared with conventional upper endoscopy, in detecting villous atrophy in patients with suspected celiac disease.

Whereas the conventional method showed villous atrophy in 18 of the 25 patients, capsule endoscopy found the abnormality in those plus an additional patient, he said.

The sensitivity and specificity of capsule endoscopy were 95% and 86%, respectively. Dr. de Franchis reported that the investigators did not use capsule endoscopy to test for conditions similar to celiac disease.

“PillCam endoscopy appears to be equivalent to duodenal histology in determination of villous atrophy in patients with celiac disease,” Dr. de Franchis said.

Dr. Krauss added that video capsule endoscopy should be used as the first-line evaluation in patients with confirmed celiac disease that have proved to be nonresponsive to a gluten-free diet, to exclude lymphoma, and to delineate the expansion of mucosal alterations.

CHICAGO – Health care costs for morbidly obese adults are nearly double those of normal-weight adults, according to a study presented at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.

Morbidly obese individuals make up less than 3% of the U.S. adult population, but they account for more than 10% of all health care spending in this country, reported the study's lead investigator, David E. Arterburn, M.D., of the University of Cincinnati. The study defined morbid obesity as a body mass index of 40 or greater (Int. J. Obes. Relat. Metab. Disord. 2005; 29:334–9).

Of U.S. health care expenditures, $56 billion were linked to excess body weight in the year 2000, up from a previously published estimate of $51.5 billion in 1998 (Obes. Res. 2004;12:18–24). Health care expenses for morbidly obese adults totaled more than $11 billion, Dr. Arterburn and his colleagues reported. They calculated this total by analyzing data from a nationally representative sample of 16,262 adults from the 2000 Medical Expenditure Panel Survey.

Adults who were morbidly obese had elevated costs in all health care categories, Dr. Arterburn said. Compared with adults considered to be of normal weight, morbidly obese persons had higher per capita annual expenditures for office visits, outpatient hospital care, inpatient hospitalizations, and prescription drugs.

Dr. Arterburn and his associates did not study the effect of age on health care expenditures. However, he said, “it's known there's a delay in onset of obesity-associated morbidities, so one would expect expenditures to go up with age.” The mean age of their sample was 45.4 years.

The researchers adjusted the odds of incurring health care expenses for sociodemographic variables, type of health insurance, and smoking status.

Nearly 5 million U.S. adults were morbidly obese in 2000, according to this study, supported by a grant from the Department of Veterans Affairs. Because weight and height were self-reported in the survey data, Dr. Arterburn said he believes the study underestimated the prevalence of morbid obesity.

CHICAGO – Health care costs for morbidly obese adults are nearly double those of normal-weight adults, according to a study presented at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.

Morbidly obese individuals make up less than 3% of the U.S. adult population, but they account for more than 10% of all health care spending in this country, reported the study's lead investigator, David E. Arterburn, M.D., of the University of Cincinnati. The study defined morbid obesity as a body mass index of 40 or greater (Int. J. Obes. Relat. Metab. Disord. 2005; 29:334–9).

Of U.S. health care expenditures, $56 billion were linked to excess body weight in the year 2000, up from a previously published estimate of $51.5 billion in 1998 (Obes. Res. 2004;12:18–24). Health care expenses for morbidly obese adults totaled more than $11 billion, Dr. Arterburn and his colleagues reported. They calculated this total by analyzing data from a nationally representative sample of 16,262 adults from the 2000 Medical Expenditure Panel Survey.

Adults who were morbidly obese had elevated costs in all health care categories, Dr. Arterburn said. Compared with adults considered to be of normal weight, morbidly obese persons had higher per capita annual expenditures for office visits, outpatient hospital care, inpatient hospitalizations, and prescription drugs.

Dr. Arterburn and his associates did not study the effect of age on health care expenditures. However, he said, “it's known there's a delay in onset of obesity-associated morbidities, so one would expect expenditures to go up with age.” The mean age of their sample was 45.4 years.

The researchers adjusted the odds of incurring health care expenses for sociodemographic variables, type of health insurance, and smoking status.

Nearly 5 million U.S. adults were morbidly obese in 2000, according to this study, supported by a grant from the Department of Veterans Affairs. Because weight and height were self-reported in the survey data, Dr. Arterburn said he believes the study underestimated the prevalence of morbid obesity.

CHICAGO – Health care costs for morbidly obese adults are nearly double those of normal-weight adults, according to a study presented at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.

Morbidly obese individuals make up less than 3% of the U.S. adult population, but they account for more than 10% of all health care spending in this country, reported the study's lead investigator, David E. Arterburn, M.D., of the University of Cincinnati. The study defined morbid obesity as a body mass index of 40 or greater (Int. J. Obes. Relat. Metab. Disord. 2005; 29:334–9).

Of U.S. health care expenditures, $56 billion were linked to excess body weight in the year 2000, up from a previously published estimate of $51.5 billion in 1998 (Obes. Res. 2004;12:18–24). Health care expenses for morbidly obese adults totaled more than $11 billion, Dr. Arterburn and his colleagues reported. They calculated this total by analyzing data from a nationally representative sample of 16,262 adults from the 2000 Medical Expenditure Panel Survey.

Adults who were morbidly obese had elevated costs in all health care categories, Dr. Arterburn said. Compared with adults considered to be of normal weight, morbidly obese persons had higher per capita annual expenditures for office visits, outpatient hospital care, inpatient hospitalizations, and prescription drugs.

Dr. Arterburn and his associates did not study the effect of age on health care expenditures. However, he said, “it's known there's a delay in onset of obesity-associated morbidities, so one would expect expenditures to go up with age.” The mean age of their sample was 45.4 years.

The researchers adjusted the odds of incurring health care expenses for sociodemographic variables, type of health insurance, and smoking status.

Nearly 5 million U.S. adults were morbidly obese in 2000, according to this study, supported by a grant from the Department of Veterans Affairs. Because weight and height were self-reported in the survey data, Dr. Arterburn said he believes the study underestimated the prevalence of morbid obesity.

CHICAGO — Active ulcerative colitis responds to the drug infliximab, according to results of two multicenter phase III trials reported at the annual Digestive Disease Week.

Active Colitis Trial (ACT) 1 and ACT 2 each enrolled 364 patients with moderate or severe ulcerative colitis, refractory to at least one standard therapy.

Investigators randomized patients to receive infliximab at a 5 mg/kg dosage, a 10 mg/kg dosage, or placebo at baseline and at weeks 2 and 6, and then every 8 weeks through week 46.

After 8 weeks of infliximab therapy at either dosage, more than 60% of patients in each trial demonstrated improvement in their symptoms vs. approximately 29% and 37% of placebo-treated patients in ACT 1 and 2, respectively, the authors reported. At 30 weeks, the clinical response was still significantly better in the infliximab groups.

Infliximab also effectively induced remission and led to mucosal healing in patients with active ulcerative colitis, both studies showed.

“This is very encouraging news for a patient population that has few treatment options,” said William Sandborn, M.D., principal investigator of ACT 2 and head of the Mayo Clinic College of Medicine's irritable bowel disease interest group and clinical research unit.

Both ACT 1 and 2 trials had similar results and patient populations, according to Dr. Sandborn, whose institution was one of 55 study centers. He described subjects as outpatients with relatively stable disease.

At enrollment, ACT 1 patients had not responded to treatment with corticosteroids and/or immunosuppressive therapy, whereas patients in ACT 2 had experienced treatment failure with 5-aminosalicylates, steroids, and/or immunosuppressives. The duration of ACT 1 also was longer (54 vs. 30 weeks).

Clinical response was defined as a decrease in the Mayo score of at least 30% and 3 or more points, plus either a reduction of 1 or more points in the rectal bleeding score or a score of 0 or 1 at week 8.

In addition to clinical response, both trials studied clinical remission—a Mayo score of 2 or less, with no individual subscores greater than 1—and mucosal healing, characterized as an endoscopy subscore of 0 or 1.

Remission rates for the drug-treated patients were as high as 39% in ACT 1 (5 mg/kg) at week 8, compared with 15% for placebo. In ACT 1, the difference in the patients' 8-week remission rates between the 10 mg/kg infliximab dosage (32%) and placebo was highly statistically significant, said that trial's lead investigator, Paul Rutgeerts, M.D., from the University Hospital, Leuven, Belgium. Dr. Rutgeerts is a grant recipient of Centocor, the manufacturer of infliximab (Remicade).

Significant differences in remission rates between infliximab and placebo also were evident in ACT 2 and continued at 30 weeks in both trials.

Mucosal healing occurred at week 30 in a higher percentage of patients receiving 10 mg/kg of infliximab than in those with the smaller dosage (50% vs. 49% in ACT 1; 57% vs. 46% in ACT 2). Healing rates for both dosages were significantly higher than for placebo (25% in ACT 1; 30% in ACT 2).

In each study, the proportion of patients who were in remission and able to stop use of corticosteroids after 30 weeks of infliximab therapy was significantly greater for both dosages, compared with placebo.

Dr. Sandborn is also a grant recipient of Centocor.

CHICAGO — Active ulcerative colitis responds to the drug infliximab, according to results of two multicenter phase III trials reported at the annual Digestive Disease Week.

Active Colitis Trial (ACT) 1 and ACT 2 each enrolled 364 patients with moderate or severe ulcerative colitis, refractory to at least one standard therapy.

Investigators randomized patients to receive infliximab at a 5 mg/kg dosage, a 10 mg/kg dosage, or placebo at baseline and at weeks 2 and 6, and then every 8 weeks through week 46.

After 8 weeks of infliximab therapy at either dosage, more than 60% of patients in each trial demonstrated improvement in their symptoms vs. approximately 29% and 37% of placebo-treated patients in ACT 1 and 2, respectively, the authors reported. At 30 weeks, the clinical response was still significantly better in the infliximab groups.

Infliximab also effectively induced remission and led to mucosal healing in patients with active ulcerative colitis, both studies showed.

“This is very encouraging news for a patient population that has few treatment options,” said William Sandborn, M.D., principal investigator of ACT 2 and head of the Mayo Clinic College of Medicine's irritable bowel disease interest group and clinical research unit.

Both ACT 1 and 2 trials had similar results and patient populations, according to Dr. Sandborn, whose institution was one of 55 study centers. He described subjects as outpatients with relatively stable disease.

At enrollment, ACT 1 patients had not responded to treatment with corticosteroids and/or immunosuppressive therapy, whereas patients in ACT 2 had experienced treatment failure with 5-aminosalicylates, steroids, and/or immunosuppressives. The duration of ACT 1 also was longer (54 vs. 30 weeks).

Clinical response was defined as a decrease in the Mayo score of at least 30% and 3 or more points, plus either a reduction of 1 or more points in the rectal bleeding score or a score of 0 or 1 at week 8.

In addition to clinical response, both trials studied clinical remission—a Mayo score of 2 or less, with no individual subscores greater than 1—and mucosal healing, characterized as an endoscopy subscore of 0 or 1.

Remission rates for the drug-treated patients were as high as 39% in ACT 1 (5 mg/kg) at week 8, compared with 15% for placebo. In ACT 1, the difference in the patients' 8-week remission rates between the 10 mg/kg infliximab dosage (32%) and placebo was highly statistically significant, said that trial's lead investigator, Paul Rutgeerts, M.D., from the University Hospital, Leuven, Belgium. Dr. Rutgeerts is a grant recipient of Centocor, the manufacturer of infliximab (Remicade).

Significant differences in remission rates between infliximab and placebo also were evident in ACT 2 and continued at 30 weeks in both trials.

Mucosal healing occurred at week 30 in a higher percentage of patients receiving 10 mg/kg of infliximab than in those with the smaller dosage (50% vs. 49% in ACT 1; 57% vs. 46% in ACT 2). Healing rates for both dosages were significantly higher than for placebo (25% in ACT 1; 30% in ACT 2).

In each study, the proportion of patients who were in remission and able to stop use of corticosteroids after 30 weeks of infliximab therapy was significantly greater for both dosages, compared with placebo.

Dr. Sandborn is also a grant recipient of Centocor.

CHICAGO — Active ulcerative colitis responds to the drug infliximab, according to results of two multicenter phase III trials reported at the annual Digestive Disease Week.

Active Colitis Trial (ACT) 1 and ACT 2 each enrolled 364 patients with moderate or severe ulcerative colitis, refractory to at least one standard therapy.

Investigators randomized patients to receive infliximab at a 5 mg/kg dosage, a 10 mg/kg dosage, or placebo at baseline and at weeks 2 and 6, and then every 8 weeks through week 46.

After 8 weeks of infliximab therapy at either dosage, more than 60% of patients in each trial demonstrated improvement in their symptoms vs. approximately 29% and 37% of placebo-treated patients in ACT 1 and 2, respectively, the authors reported. At 30 weeks, the clinical response was still significantly better in the infliximab groups.

Infliximab also effectively induced remission and led to mucosal healing in patients with active ulcerative colitis, both studies showed.

“This is very encouraging news for a patient population that has few treatment options,” said William Sandborn, M.D., principal investigator of ACT 2 and head of the Mayo Clinic College of Medicine's irritable bowel disease interest group and clinical research unit.

Both ACT 1 and 2 trials had similar results and patient populations, according to Dr. Sandborn, whose institution was one of 55 study centers. He described subjects as outpatients with relatively stable disease.

At enrollment, ACT 1 patients had not responded to treatment with corticosteroids and/or immunosuppressive therapy, whereas patients in ACT 2 had experienced treatment failure with 5-aminosalicylates, steroids, and/or immunosuppressives. The duration of ACT 1 also was longer (54 vs. 30 weeks).

Clinical response was defined as a decrease in the Mayo score of at least 30% and 3 or more points, plus either a reduction of 1 or more points in the rectal bleeding score or a score of 0 or 1 at week 8.

In addition to clinical response, both trials studied clinical remission—a Mayo score of 2 or less, with no individual subscores greater than 1—and mucosal healing, characterized as an endoscopy subscore of 0 or 1.

Remission rates for the drug-treated patients were as high as 39% in ACT 1 (5 mg/kg) at week 8, compared with 15% for placebo. In ACT 1, the difference in the patients' 8-week remission rates between the 10 mg/kg infliximab dosage (32%) and placebo was highly statistically significant, said that trial's lead investigator, Paul Rutgeerts, M.D., from the University Hospital, Leuven, Belgium. Dr. Rutgeerts is a grant recipient of Centocor, the manufacturer of infliximab (Remicade).

Significant differences in remission rates between infliximab and placebo also were evident in ACT 2 and continued at 30 weeks in both trials.

Mucosal healing occurred at week 30 in a higher percentage of patients receiving 10 mg/kg of infliximab than in those with the smaller dosage (50% vs. 49% in ACT 1; 57% vs. 46% in ACT 2). Healing rates for both dosages were significantly higher than for placebo (25% in ACT 1; 30% in ACT 2).

In each study, the proportion of patients who were in remission and able to stop use of corticosteroids after 30 weeks of infliximab therapy was significantly greater for both dosages, compared with placebo.

Dr. Sandborn is also a grant recipient of Centocor.

CHICAGO — Confocal scanning laser endomicroscopy combined with chromoendoscopy identifies more precancerous lesions in patients with ulcerative colitis than does standard colonoscopy, investigators reported at the annual Digestive Disease Week.

This new method can accurately detect both intraepithelial neoplasms and colitis-associated colorectal carcinomas, according to the study's principal investigator, Ralf Kiesslich, M.D., of Johannes Gutenberg University, Mainz, Germany. Called confocal endomicroscopy, the method involves insertion of a confocal microscope into a traditional endoscope.

The study enrolled 153 patients with long-term ulcerative colitis in remission. Of those, 80 were randomized to undergo panchromoendoscopy with injection of 0.1% methylene blue dye for enhanced viewing of the colonic mucosal surface. All circumscribed lesions in the colonic mucosa that chromoendoscopy detected were then evaluated with confocal endomicroscopy for cellular and vascular changes. Targeted biopsies were performed of all circumscribed lesions.

The other 73 patients underwent standard colonoscopy. In this group, targeted biopsy specimens of visible mucosal changes were obtained in addition to biopsy specimens every 10 cm between the anus and cecum.

Confocal endomicroscopy helped detect 19 intraepithelial neoplasms, but colonoscopy found only 4, a statistically significant difference. The new technique identified lesions with an accuracy of nearly 98%. This high accuracy is the result of a combination of chromoendoscopy, which unmasks circumscribed lesions, and endomicroscopy, which allows in vivo diagnosis, Dr. Kiesslich said in an interview.

Confocal endomicroscopy also reduced the number of biopsies to 21, compared with 42 in the conventional endoscopy group.

With this new system, biopsies can be limited to relevant lesions—those with visible mucosal changes—thus allowing for “smart” biopsies, Dr. Kiesslich said in a statement. Confocal endomicroscopy may, therefore, improve the management of ulcerative colitis and lead to early detection of precancerous and cancerous lesions of the colon.

Paul Silva, director of regulatory affairs for Pentax Precision Instrument Corp., the device maker, said, “In North America, Pentax is sponsoring a clinical multisite trial of the device to collect data for [FDA] clearance as a biopsy-targeting system.”

Pentax's European division provided research support for this study.

CHICAGO — Confocal scanning laser endomicroscopy combined with chromoendoscopy identifies more precancerous lesions in patients with ulcerative colitis than does standard colonoscopy, investigators reported at the annual Digestive Disease Week.

This new method can accurately detect both intraepithelial neoplasms and colitis-associated colorectal carcinomas, according to the study's principal investigator, Ralf Kiesslich, M.D., of Johannes Gutenberg University, Mainz, Germany. Called confocal endomicroscopy, the method involves insertion of a confocal microscope into a traditional endoscope.

The study enrolled 153 patients with long-term ulcerative colitis in remission. Of those, 80 were randomized to undergo panchromoendoscopy with injection of 0.1% methylene blue dye for enhanced viewing of the colonic mucosal surface. All circumscribed lesions in the colonic mucosa that chromoendoscopy detected were then evaluated with confocal endomicroscopy for cellular and vascular changes. Targeted biopsies were performed of all circumscribed lesions.

The other 73 patients underwent standard colonoscopy. In this group, targeted biopsy specimens of visible mucosal changes were obtained in addition to biopsy specimens every 10 cm between the anus and cecum.

Confocal endomicroscopy helped detect 19 intraepithelial neoplasms, but colonoscopy found only 4, a statistically significant difference. The new technique identified lesions with an accuracy of nearly 98%. This high accuracy is the result of a combination of chromoendoscopy, which unmasks circumscribed lesions, and endomicroscopy, which allows in vivo diagnosis, Dr. Kiesslich said in an interview.

Confocal endomicroscopy also reduced the number of biopsies to 21, compared with 42 in the conventional endoscopy group.

With this new system, biopsies can be limited to relevant lesions—those with visible mucosal changes—thus allowing for “smart” biopsies, Dr. Kiesslich said in a statement. Confocal endomicroscopy may, therefore, improve the management of ulcerative colitis and lead to early detection of precancerous and cancerous lesions of the colon.

Paul Silva, director of regulatory affairs for Pentax Precision Instrument Corp., the device maker, said, “In North America, Pentax is sponsoring a clinical multisite trial of the device to collect data for [FDA] clearance as a biopsy-targeting system.”

Pentax's European division provided research support for this study.

CHICAGO — Confocal scanning laser endomicroscopy combined with chromoendoscopy identifies more precancerous lesions in patients with ulcerative colitis than does standard colonoscopy, investigators reported at the annual Digestive Disease Week.

This new method can accurately detect both intraepithelial neoplasms and colitis-associated colorectal carcinomas, according to the study's principal investigator, Ralf Kiesslich, M.D., of Johannes Gutenberg University, Mainz, Germany. Called confocal endomicroscopy, the method involves insertion of a confocal microscope into a traditional endoscope.

The study enrolled 153 patients with long-term ulcerative colitis in remission. Of those, 80 were randomized to undergo panchromoendoscopy with injection of 0.1% methylene blue dye for enhanced viewing of the colonic mucosal surface. All circumscribed lesions in the colonic mucosa that chromoendoscopy detected were then evaluated with confocal endomicroscopy for cellular and vascular changes. Targeted biopsies were performed of all circumscribed lesions.

The other 73 patients underwent standard colonoscopy. In this group, targeted biopsy specimens of visible mucosal changes were obtained in addition to biopsy specimens every 10 cm between the anus and cecum.

Confocal endomicroscopy helped detect 19 intraepithelial neoplasms, but colonoscopy found only 4, a statistically significant difference. The new technique identified lesions with an accuracy of nearly 98%. This high accuracy is the result of a combination of chromoendoscopy, which unmasks circumscribed lesions, and endomicroscopy, which allows in vivo diagnosis, Dr. Kiesslich said in an interview.

Confocal endomicroscopy also reduced the number of biopsies to 21, compared with 42 in the conventional endoscopy group.

With this new system, biopsies can be limited to relevant lesions—those with visible mucosal changes—thus allowing for “smart” biopsies, Dr. Kiesslich said in a statement. Confocal endomicroscopy may, therefore, improve the management of ulcerative colitis and lead to early detection of precancerous and cancerous lesions of the colon.

Paul Silva, director of regulatory affairs for Pentax Precision Instrument Corp., the device maker, said, “In North America, Pentax is sponsoring a clinical multisite trial of the device to collect data for [FDA] clearance as a biopsy-targeting system.”

Pentax's European division provided research support for this study.

CHICAGO — Patients with bleeding peptic ulcers have quicker resolution of bleeding stigmata and less need for endoscopic therapy if they receive high-dose intravenous omeprazole before endoscopy, James Lau, M.D., reported at the annual Digestive Disease Week.

Dr. Lau, director of the endoscopy center at Prince of Wales Hospital in Hong Kong, presented the results of a double-blind, placebo-controlled trial of omeprazole in 369 patients with overt signs of upper GI bleeding who were scheduled for endoscopy.

Between February and November 2004, Dr. Lau and his coinvestigators randomized 179 of the patients to receive an 80-mg IV bolus of omeprazole and 8 mg/h before endoscopy (mean hours of infusion 14.9). The other 190 patients received a placebo before the procedure.

At endoscopy, a bleeding peptic ulcer was the most common cause of upper GI bleeding found. Bleeding ulcers were documented in 110 patients who had received high-dose omeprazole (61%) and 112 patients who had received placebo (59%) before endoscopy.

The primary outcome measured was the need for endoscopic treatment, which consisted of epinephrine injection and heater probe thermocoagulation for actively bleeding ulcers or ulcers with nonbleeding visible vessels or clots. Significantly fewer patients with bleeding ulcers in the omeprazole group needed endoscopic treatment, compared with the placebo group (19 of 110 patients vs. 40 of 112), he said.

In this subgroup, only 20 (18%) of the 110 patients who received omeprazole had endoscopic stigmata of bleeding, whereas 41 (37%) of the 112 patients who received placebo had bleeding stigmata. The difference was statistically significant.

Preemptive use of high-dose omeprazole appears to have not only hemostatic effects but also healing effects, Dr. Lau said. Data showed significantly more clean-base ulcers at index endoscopy in patients assigned to the proton pump inhibitor than in those on placebo (74 vs. 50, respectively).

CHICAGO — Patients with bleeding peptic ulcers have quicker resolution of bleeding stigmata and less need for endoscopic therapy if they receive high-dose intravenous omeprazole before endoscopy, James Lau, M.D., reported at the annual Digestive Disease Week.

Dr. Lau, director of the endoscopy center at Prince of Wales Hospital in Hong Kong, presented the results of a double-blind, placebo-controlled trial of omeprazole in 369 patients with overt signs of upper GI bleeding who were scheduled for endoscopy.

Between February and November 2004, Dr. Lau and his coinvestigators randomized 179 of the patients to receive an 80-mg IV bolus of omeprazole and 8 mg/h before endoscopy (mean hours of infusion 14.9). The other 190 patients received a placebo before the procedure.

At endoscopy, a bleeding peptic ulcer was the most common cause of upper GI bleeding found. Bleeding ulcers were documented in 110 patients who had received high-dose omeprazole (61%) and 112 patients who had received placebo (59%) before endoscopy.

The primary outcome measured was the need for endoscopic treatment, which consisted of epinephrine injection and heater probe thermocoagulation for actively bleeding ulcers or ulcers with nonbleeding visible vessels or clots. Significantly fewer patients with bleeding ulcers in the omeprazole group needed endoscopic treatment, compared with the placebo group (19 of 110 patients vs. 40 of 112), he said.

In this subgroup, only 20 (18%) of the 110 patients who received omeprazole had endoscopic stigmata of bleeding, whereas 41 (37%) of the 112 patients who received placebo had bleeding stigmata. The difference was statistically significant.

Preemptive use of high-dose omeprazole appears to have not only hemostatic effects but also healing effects, Dr. Lau said. Data showed significantly more clean-base ulcers at index endoscopy in patients assigned to the proton pump inhibitor than in those on placebo (74 vs. 50, respectively).

CHICAGO — Patients with bleeding peptic ulcers have quicker resolution of bleeding stigmata and less need for endoscopic therapy if they receive high-dose intravenous omeprazole before endoscopy, James Lau, M.D., reported at the annual Digestive Disease Week.

Dr. Lau, director of the endoscopy center at Prince of Wales Hospital in Hong Kong, presented the results of a double-blind, placebo-controlled trial of omeprazole in 369 patients with overt signs of upper GI bleeding who were scheduled for endoscopy.

Between February and November 2004, Dr. Lau and his coinvestigators randomized 179 of the patients to receive an 80-mg IV bolus of omeprazole and 8 mg/h before endoscopy (mean hours of infusion 14.9). The other 190 patients received a placebo before the procedure.

At endoscopy, a bleeding peptic ulcer was the most common cause of upper GI bleeding found. Bleeding ulcers were documented in 110 patients who had received high-dose omeprazole (61%) and 112 patients who had received placebo (59%) before endoscopy.

The primary outcome measured was the need for endoscopic treatment, which consisted of epinephrine injection and heater probe thermocoagulation for actively bleeding ulcers or ulcers with nonbleeding visible vessels or clots. Significantly fewer patients with bleeding ulcers in the omeprazole group needed endoscopic treatment, compared with the placebo group (19 of 110 patients vs. 40 of 112), he said.

In this subgroup, only 20 (18%) of the 110 patients who received omeprazole had endoscopic stigmata of bleeding, whereas 41 (37%) of the 112 patients who received placebo had bleeding stigmata. The difference was statistically significant.

Preemptive use of high-dose omeprazole appears to have not only hemostatic effects but also healing effects, Dr. Lau said. Data showed significantly more clean-base ulcers at index endoscopy in patients assigned to the proton pump inhibitor than in those on placebo (74 vs. 50, respectively).

CHICAGO — Extended criteria for liver donor allografts, including the use of living donors, increase access to liver transplantation and significantly reduce wait-list mortality while providing satisfactory outcomes, according to researchers at New York-Presbyterian Hospital.

Allografts that do not meet traditional donor criteria can offer immediate expansion of the donor pool in regions of donor scarcity, said Cindy Kin, a medical student at the hospital and lead author of the study, at the annual Digestive Disease Week. As of August, approximately 2,200 people were waiting for a liver in New York, which is second only to California for the nation's longest wait list, according to the United Network for Organ Sharing (UNOS).

In a study conducted between April 2001 and April 2004, Ms. Kin and her coauthors compared patient access to and outcomes of liver transplantation between two groups: 128 recipients of primarily traditional donor criteria allografts and 99 recipients of extended donor criteria (EDC) allografts. The latter group included allografts from cadaver donors who were older than 65 years of age at time of death; had cardiac death or a history of cancer; were positive for hepatitis C, hepatitis B core antibody, or human T-lymphotropic virus; had macrovesicular steatosis above 40% or a serum sodium level exceeding 155 mEq/dL; or engaged in high-risk behaviors. Allografts from living donors also were included in the EDC group, as were split-liver cadaver allografts.

Data collected during the 3-year study period revealed that systematic use of EDC in select recipients increased patient access to liver transplantation by 77% and reduced mortality before transplantation by more than 50%, compared with use of primarily traditional donor allografts, Ms. Kin reported.

The allocation of EDC livers involved careful selection of patients suited to allograft and advance planning to prepare patients who face potentially long wait times for the use of EDC, Ms. Kin said in an interview.

Biliary complications were more common in living donor transplant recipients, but vascular and wound complications did not vary between groups, she said.

CHICAGO — Extended criteria for liver donor allografts, including the use of living donors, increase access to liver transplantation and significantly reduce wait-list mortality while providing satisfactory outcomes, according to researchers at New York-Presbyterian Hospital.

Allografts that do not meet traditional donor criteria can offer immediate expansion of the donor pool in regions of donor scarcity, said Cindy Kin, a medical student at the hospital and lead author of the study, at the annual Digestive Disease Week. As of August, approximately 2,200 people were waiting for a liver in New York, which is second only to California for the nation's longest wait list, according to the United Network for Organ Sharing (UNOS).

In a study conducted between April 2001 and April 2004, Ms. Kin and her coauthors compared patient access to and outcomes of liver transplantation between two groups: 128 recipients of primarily traditional donor criteria allografts and 99 recipients of extended donor criteria (EDC) allografts. The latter group included allografts from cadaver donors who were older than 65 years of age at time of death; had cardiac death or a history of cancer; were positive for hepatitis C, hepatitis B core antibody, or human T-lymphotropic virus; had macrovesicular steatosis above 40% or a serum sodium level exceeding 155 mEq/dL; or engaged in high-risk behaviors. Allografts from living donors also were included in the EDC group, as were split-liver cadaver allografts.

Data collected during the 3-year study period revealed that systematic use of EDC in select recipients increased patient access to liver transplantation by 77% and reduced mortality before transplantation by more than 50%, compared with use of primarily traditional donor allografts, Ms. Kin reported.

The allocation of EDC livers involved careful selection of patients suited to allograft and advance planning to prepare patients who face potentially long wait times for the use of EDC, Ms. Kin said in an interview.

Biliary complications were more common in living donor transplant recipients, but vascular and wound complications did not vary between groups, she said.

CHICAGO — Extended criteria for liver donor allografts, including the use of living donors, increase access to liver transplantation and significantly reduce wait-list mortality while providing satisfactory outcomes, according to researchers at New York-Presbyterian Hospital.

Allografts that do not meet traditional donor criteria can offer immediate expansion of the donor pool in regions of donor scarcity, said Cindy Kin, a medical student at the hospital and lead author of the study, at the annual Digestive Disease Week. As of August, approximately 2,200 people were waiting for a liver in New York, which is second only to California for the nation's longest wait list, according to the United Network for Organ Sharing (UNOS).

In a study conducted between April 2001 and April 2004, Ms. Kin and her coauthors compared patient access to and outcomes of liver transplantation between two groups: 128 recipients of primarily traditional donor criteria allografts and 99 recipients of extended donor criteria (EDC) allografts. The latter group included allografts from cadaver donors who were older than 65 years of age at time of death; had cardiac death or a history of cancer; were positive for hepatitis C, hepatitis B core antibody, or human T-lymphotropic virus; had macrovesicular steatosis above 40% or a serum sodium level exceeding 155 mEq/dL; or engaged in high-risk behaviors. Allografts from living donors also were included in the EDC group, as were split-liver cadaver allografts.

Data collected during the 3-year study period revealed that systematic use of EDC in select recipients increased patient access to liver transplantation by 77% and reduced mortality before transplantation by more than 50%, compared with use of primarily traditional donor allografts, Ms. Kin reported.

The allocation of EDC livers involved careful selection of patients suited to allograft and advance planning to prepare patients who face potentially long wait times for the use of EDC, Ms. Kin said in an interview.

Biliary complications were more common in living donor transplant recipients, but vascular and wound complications did not vary between groups, she said.

CHICAGO — Cardiologists might not be adequately protecting their coronary artery-stenting patients against the risk of upper GI bleeding due to antiplatelet therapy, according to a poster presented at the annual Digestive Disease Week.

The study, led by Steven Chang, M.D., was a chart review of 636 randomly selected patients who received stents at three institutions, including Chicago's Northwestern Memorial Hospital. Most patients received aspirin before (72%) and/or after (97%) stent placement, which increased their risk of peptic ulcer-related bleeding, according to Dr. Chang and his colleagues.

After stenting, however, only 24% were prescribed a proton pump inhibitor (PPI), reported Dr. Chang, who is a consultant to Santarus, a manufacturer of omeprazole.

Three of the stent recipients had a documented history of upper-GI bleeding, 23 had a history of peptic ulcer disease, and 30 were receiving NSAID therapy that was not stopped before stenting. “Few coronary stent patients who are started on aspirin and other antiplatelet agents receive appropriate GI prophylaxis,” Dr. Chang wrote.

But it might not be cost effective to prescribe a PPI to all patients before stent placement, he added. “We recommend that cardiologists give PPIs to patients at risk [of upper GI bleeding] before stenting.”

CHICAGO — Cardiologists might not be adequately protecting their coronary artery-stenting patients against the risk of upper GI bleeding due to antiplatelet therapy, according to a poster presented at the annual Digestive Disease Week.

The study, led by Steven Chang, M.D., was a chart review of 636 randomly selected patients who received stents at three institutions, including Chicago's Northwestern Memorial Hospital. Most patients received aspirin before (72%) and/or after (97%) stent placement, which increased their risk of peptic ulcer-related bleeding, according to Dr. Chang and his colleagues.

After stenting, however, only 24% were prescribed a proton pump inhibitor (PPI), reported Dr. Chang, who is a consultant to Santarus, a manufacturer of omeprazole.

Three of the stent recipients had a documented history of upper-GI bleeding, 23 had a history of peptic ulcer disease, and 30 were receiving NSAID therapy that was not stopped before stenting. “Few coronary stent patients who are started on aspirin and other antiplatelet agents receive appropriate GI prophylaxis,” Dr. Chang wrote.

But it might not be cost effective to prescribe a PPI to all patients before stent placement, he added. “We recommend that cardiologists give PPIs to patients at risk [of upper GI bleeding] before stenting.”

CHICAGO — Cardiologists might not be adequately protecting their coronary artery-stenting patients against the risk of upper GI bleeding due to antiplatelet therapy, according to a poster presented at the annual Digestive Disease Week.

The study, led by Steven Chang, M.D., was a chart review of 636 randomly selected patients who received stents at three institutions, including Chicago's Northwestern Memorial Hospital. Most patients received aspirin before (72%) and/or after (97%) stent placement, which increased their risk of peptic ulcer-related bleeding, according to Dr. Chang and his colleagues.

After stenting, however, only 24% were prescribed a proton pump inhibitor (PPI), reported Dr. Chang, who is a consultant to Santarus, a manufacturer of omeprazole.

Three of the stent recipients had a documented history of upper-GI bleeding, 23 had a history of peptic ulcer disease, and 30 were receiving NSAID therapy that was not stopped before stenting. “Few coronary stent patients who are started on aspirin and other antiplatelet agents receive appropriate GI prophylaxis,” Dr. Chang wrote.

But it might not be cost effective to prescribe a PPI to all patients before stent placement, he added. “We recommend that cardiologists give PPIs to patients at risk [of upper GI bleeding] before stenting.”

CHICAGO — Four percent of primary care physicians and third-year medical students surveyed in a regional study reported that they made errors resulting in a patient's death but did not disclose them to their institution, Lauris C. Kaldjian, M.D., said at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.

Dr. Kaldjian surveyed faculty, residents, and third-year medical students in the departments of internal medicine, family medicine, and pediatrics at two medical schools and three hospitals in the Midwest and Northeast. The 538 responses were weighted more heavily toward residents and students than faculty members.

Of respondents, 17% did not disclose to their institution medical errors that prolonged the course of treatment or caused discomfort, and 12% did not disclose to the patient.

Still, more primary care physicians and students voluntarily disclosed medical errors than those who did not, said Dr. Kaldjian, a bioethicist at the University of Iowa.

Of the respondents, 27% revealed to the patient a medical error that prolonged therapy, and 18% disclosed such a mistake to their institutions.

The study was designed to develop a comprehensive taxonomy of the factors that influence voluntary disclosure of errors by physicians and to use the taxonomy in a cross-sectional survey of primary care physicians. The survey asked about factors that facilitate the voluntary disclosure of medical errors in four domains: a sense of responsibility to the patient, oneself, the medical profession, and the community. It also solicited reasons that impede disclo-sure of errors in four domains: attitudinal barriers, uncertainties, helplessness, and fears and anxiety.

These eight domains included 59 factors that either facilitate disclosure, such as the belief that telling patients about mistakes increases their trust in the physician, or hinder disclosure—for example, fear of legal liability.

“This study is trying to get at the deepest motivations and barriers that come into our minds and even our hearts when it comes to talking to patients about medical errors,” said Dr. Kaldjian, whose work was funded by the Robert Wood Johnson Foundation. “The issue of disclosure of errors has come to the fore in recent years because of the patient safety movement.”

Among fears, the most common reason survey respondents did not disclose an error was fear of the patient's or family's reaction (88%).

Women in the study were more inclined than men to disclose their errors to patients. Faculty members appeared more willing than trainees to disclose errors to their patients but not as willing to disclose to their colleagues.

Dr. Kaldjian did not break down medical errors other than those that prolonged therapy or caused discomfort and those that caused death, he told FAMILY PRACTICE NEWS.

The taxonomy he developed may assist in the design of systems for reporting medical errors and might be helpful for educational interventions, Dr. Kaldjian said.

CHICAGO — Four percent of primary care physicians and third-year medical students surveyed in a regional study reported that they made errors resulting in a patient's death but did not disclose them to their institution, Lauris C. Kaldjian, M.D., said at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.

Dr. Kaldjian surveyed faculty, residents, and third-year medical students in the departments of internal medicine, family medicine, and pediatrics at two medical schools and three hospitals in the Midwest and Northeast. The 538 responses were weighted more heavily toward residents and students than faculty members.

Of respondents, 17% did not disclose to their institution medical errors that prolonged the course of treatment or caused discomfort, and 12% did not disclose to the patient.

Still, more primary care physicians and students voluntarily disclosed medical errors than those who did not, said Dr. Kaldjian, a bioethicist at the University of Iowa.

Of the respondents, 27% revealed to the patient a medical error that prolonged therapy, and 18% disclosed such a mistake to their institutions.

The study was designed to develop a comprehensive taxonomy of the factors that influence voluntary disclosure of errors by physicians and to use the taxonomy in a cross-sectional survey of primary care physicians. The survey asked about factors that facilitate the voluntary disclosure of medical errors in four domains: a sense of responsibility to the patient, oneself, the medical profession, and the community. It also solicited reasons that impede disclo-sure of errors in four domains: attitudinal barriers, uncertainties, helplessness, and fears and anxiety.

These eight domains included 59 factors that either facilitate disclosure, such as the belief that telling patients about mistakes increases their trust in the physician, or hinder disclosure—for example, fear of legal liability.

“This study is trying to get at the deepest motivations and barriers that come into our minds and even our hearts when it comes to talking to patients about medical errors,” said Dr. Kaldjian, whose work was funded by the Robert Wood Johnson Foundation. “The issue of disclosure of errors has come to the fore in recent years because of the patient safety movement.”

Among fears, the most common reason survey respondents did not disclose an error was fear of the patient's or family's reaction (88%).

Women in the study were more inclined than men to disclose their errors to patients. Faculty members appeared more willing than trainees to disclose errors to their patients but not as willing to disclose to their colleagues.

Dr. Kaldjian did not break down medical errors other than those that prolonged therapy or caused discomfort and those that caused death, he told FAMILY PRACTICE NEWS.

The taxonomy he developed may assist in the design of systems for reporting medical errors and might be helpful for educational interventions, Dr. Kaldjian said.

CHICAGO — Four percent of primary care physicians and third-year medical students surveyed in a regional study reported that they made errors resulting in a patient's death but did not disclose them to their institution, Lauris C. Kaldjian, M.D., said at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.

Dr. Kaldjian surveyed faculty, residents, and third-year medical students in the departments of internal medicine, family medicine, and pediatrics at two medical schools and three hospitals in the Midwest and Northeast. The 538 responses were weighted more heavily toward residents and students than faculty members.

Of respondents, 17% did not disclose to their institution medical errors that prolonged the course of treatment or caused discomfort, and 12% did not disclose to the patient.

Still, more primary care physicians and students voluntarily disclosed medical errors than those who did not, said Dr. Kaldjian, a bioethicist at the University of Iowa.

Of the respondents, 27% revealed to the patient a medical error that prolonged therapy, and 18% disclosed such a mistake to their institutions.

The study was designed to develop a comprehensive taxonomy of the factors that influence voluntary disclosure of errors by physicians and to use the taxonomy in a cross-sectional survey of primary care physicians. The survey asked about factors that facilitate the voluntary disclosure of medical errors in four domains: a sense of responsibility to the patient, oneself, the medical profession, and the community. It also solicited reasons that impede disclo-sure of errors in four domains: attitudinal barriers, uncertainties, helplessness, and fears and anxiety.

These eight domains included 59 factors that either facilitate disclosure, such as the belief that telling patients about mistakes increases their trust in the physician, or hinder disclosure—for example, fear of legal liability.

“This study is trying to get at the deepest motivations and barriers that come into our minds and even our hearts when it comes to talking to patients about medical errors,” said Dr. Kaldjian, whose work was funded by the Robert Wood Johnson Foundation. “The issue of disclosure of errors has come to the fore in recent years because of the patient safety movement.”

Among fears, the most common reason survey respondents did not disclose an error was fear of the patient's or family's reaction (88%).

Women in the study were more inclined than men to disclose their errors to patients. Faculty members appeared more willing than trainees to disclose errors to their patients but not as willing to disclose to their colleagues.

Dr. Kaldjian did not break down medical errors other than those that prolonged therapy or caused discomfort and those that caused death, he told FAMILY PRACTICE NEWS.

The taxonomy he developed may assist in the design of systems for reporting medical errors and might be helpful for educational interventions, Dr. Kaldjian said.