Denise Napoli

Among patients with infected pancreatic necrosis, both surgical necrosectomy and conservative treatment with antibiotics had comparable mortality rates, Dr. Pramod Kumar Garg and colleagues reported in the December issue of Clinical Gastroenterology and Hepatology.

However, over 10 years, the more conservatively managed patients had a better mortality rate than did the necrosectomy patients, the authors added.

"There has been no randomized comparative trial between conservative and surgical therapy in patients with IPN [infected pancreatic necrosis], primarily because conservative management was never considered a viable treatment option," wrote Dr. Garg of the department of gastroenterology at the All India Institute of Medical Sciences in New Delhi (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.04.011]).

He added that although "the present study has substantiated the emerging concept of primary conservative treatment in patients with infected pancreatic necrosis ... [it] in no way undermines the importance of surgery, preferably minimally invasive, in those patients who really merit surgical necrosectomy."

Dr. Garg and colleagues looked retrospectively at patients with infected pancreatic necrosis who were admitted to their facility in New Delhi. All cases were confirmed on culture.

Patients were divided into two groups. Group 1 was admitted between January 1997 and December 2002, and underwent surgery as their first, primary option, per hospital policy at the time. Patients who were not surgical candidates because of comorbid risk factors received conservative management.

There were 30 patients with IPN in this first group, 18 of whom had surgery after a median of 25 days and 12 of whom received conservative management.

Group 2 included patients who were admitted between January 2003 and December 2006. By this time, the institution’s protocol had changed to make aggressive medical treatment in an ICU – including combination antibiotics, organ support, intensive nutritional support, and percutaneous drainage, if required – the primary treatment. If medical treatment failed, patients underwent surgery.

This second group included 50 IPN patients, 40 of whom were managed conservatively and 10 of whom received open necrosectomy after a median of 47 days.

In group 1, the mortality rate for surgical patients was 66% (12 deaths) and 8% in the conservatively managed group (1 death), the authors reported. The difference was not statistically significant.

In group 2, 3 (33%) of the 10 patients who were treated surgically died, and of the 40 patients who were treated conservatively, 11 (28%) died. This difference did not reach statistical significance, either.

Overall, that translated to a mortality rate of 28% for group 2, compared with a rate of 43% in group 1, which also was not statistically significant.

"However, of the total 80 patients with IPN over the 10-year period, there was a significantly higher survival among patients treated medically [40 of 52 patients, or 77%] compared with those treated surgically [13 of 28 patients, or 46%]" (P = .005), wrote the authors.

The researchers then looked prospectively at a third group of IPN patients who were admitted between January 2007 and December 2008. Group 3 was handled like group 2, with aggressive antibiotic treatment in an ICU as the primary treatment, followed by surgery if medical treatment failed. This third group included 27 patients with IPN (19 managed medically and 8 who had surgery).

Two patients died following surgery, whereas six died following medical treatment, for an overall mortality of 30% in group 3, which was similar to the overall mortality of group 2, "thus confirming the results of conservative management for IPN," wrote Dr. Garg and associates.

The researchers noted some limitations to their study, primarily that it was not randomized. "However, in the absence of convincing data about the success of conservative treatment for IPN, such a randomized trial would have been considered unethical and thus, perhaps was not possible," they added.

Dr. Garg and colleagues stated that they had no financial disclosures or conflicts of interest, and no financial support was declared for this study.

Among patients with infected pancreatic necrosis, both surgical necrosectomy and conservative treatment with antibiotics had comparable mortality rates, Dr. Pramod Kumar Garg and colleagues reported in the December issue of Clinical Gastroenterology and Hepatology.

However, over 10 years, the more conservatively managed patients had a better mortality rate than did the necrosectomy patients, the authors added.

"There has been no randomized comparative trial between conservative and surgical therapy in patients with IPN [infected pancreatic necrosis], primarily because conservative management was never considered a viable treatment option," wrote Dr. Garg of the department of gastroenterology at the All India Institute of Medical Sciences in New Delhi (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.04.011]).

He added that although "the present study has substantiated the emerging concept of primary conservative treatment in patients with infected pancreatic necrosis ... [it] in no way undermines the importance of surgery, preferably minimally invasive, in those patients who really merit surgical necrosectomy."

Dr. Garg and colleagues looked retrospectively at patients with infected pancreatic necrosis who were admitted to their facility in New Delhi. All cases were confirmed on culture.

Patients were divided into two groups. Group 1 was admitted between January 1997 and December 2002, and underwent surgery as their first, primary option, per hospital policy at the time. Patients who were not surgical candidates because of comorbid risk factors received conservative management.

There were 30 patients with IPN in this first group, 18 of whom had surgery after a median of 25 days and 12 of whom received conservative management.

Group 2 included patients who were admitted between January 2003 and December 2006. By this time, the institution’s protocol had changed to make aggressive medical treatment in an ICU – including combination antibiotics, organ support, intensive nutritional support, and percutaneous drainage, if required – the primary treatment. If medical treatment failed, patients underwent surgery.

This second group included 50 IPN patients, 40 of whom were managed conservatively and 10 of whom received open necrosectomy after a median of 47 days.

In group 1, the mortality rate for surgical patients was 66% (12 deaths) and 8% in the conservatively managed group (1 death), the authors reported. The difference was not statistically significant.

In group 2, 3 (33%) of the 10 patients who were treated surgically died, and of the 40 patients who were treated conservatively, 11 (28%) died. This difference did not reach statistical significance, either.

Overall, that translated to a mortality rate of 28% for group 2, compared with a rate of 43% in group 1, which also was not statistically significant.

"However, of the total 80 patients with IPN over the 10-year period, there was a significantly higher survival among patients treated medically [40 of 52 patients, or 77%] compared with those treated surgically [13 of 28 patients, or 46%]" (P = .005), wrote the authors.

The researchers then looked prospectively at a third group of IPN patients who were admitted between January 2007 and December 2008. Group 3 was handled like group 2, with aggressive antibiotic treatment in an ICU as the primary treatment, followed by surgery if medical treatment failed. This third group included 27 patients with IPN (19 managed medically and 8 who had surgery).

Two patients died following surgery, whereas six died following medical treatment, for an overall mortality of 30% in group 3, which was similar to the overall mortality of group 2, "thus confirming the results of conservative management for IPN," wrote Dr. Garg and associates.

The researchers noted some limitations to their study, primarily that it was not randomized. "However, in the absence of convincing data about the success of conservative treatment for IPN, such a randomized trial would have been considered unethical and thus, perhaps was not possible," they added.

Dr. Garg and colleagues stated that they had no financial disclosures or conflicts of interest, and no financial support was declared for this study.

Among patients with infected pancreatic necrosis, both surgical necrosectomy and conservative treatment with antibiotics had comparable mortality rates, Dr. Pramod Kumar Garg and colleagues reported in the December issue of Clinical Gastroenterology and Hepatology.

However, over 10 years, the more conservatively managed patients had a better mortality rate than did the necrosectomy patients, the authors added.

"There has been no randomized comparative trial between conservative and surgical therapy in patients with IPN [infected pancreatic necrosis], primarily because conservative management was never considered a viable treatment option," wrote Dr. Garg of the department of gastroenterology at the All India Institute of Medical Sciences in New Delhi (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.04.011]).

He added that although "the present study has substantiated the emerging concept of primary conservative treatment in patients with infected pancreatic necrosis ... [it] in no way undermines the importance of surgery, preferably minimally invasive, in those patients who really merit surgical necrosectomy."

Dr. Garg and colleagues looked retrospectively at patients with infected pancreatic necrosis who were admitted to their facility in New Delhi. All cases were confirmed on culture.

Patients were divided into two groups. Group 1 was admitted between January 1997 and December 2002, and underwent surgery as their first, primary option, per hospital policy at the time. Patients who were not surgical candidates because of comorbid risk factors received conservative management.

There were 30 patients with IPN in this first group, 18 of whom had surgery after a median of 25 days and 12 of whom received conservative management.

Group 2 included patients who were admitted between January 2003 and December 2006. By this time, the institution’s protocol had changed to make aggressive medical treatment in an ICU – including combination antibiotics, organ support, intensive nutritional support, and percutaneous drainage, if required – the primary treatment. If medical treatment failed, patients underwent surgery.

This second group included 50 IPN patients, 40 of whom were managed conservatively and 10 of whom received open necrosectomy after a median of 47 days.

In group 1, the mortality rate for surgical patients was 66% (12 deaths) and 8% in the conservatively managed group (1 death), the authors reported. The difference was not statistically significant.

In group 2, 3 (33%) of the 10 patients who were treated surgically died, and of the 40 patients who were treated conservatively, 11 (28%) died. This difference did not reach statistical significance, either.

Overall, that translated to a mortality rate of 28% for group 2, compared with a rate of 43% in group 1, which also was not statistically significant.

"However, of the total 80 patients with IPN over the 10-year period, there was a significantly higher survival among patients treated medically [40 of 52 patients, or 77%] compared with those treated surgically [13 of 28 patients, or 46%]" (P = .005), wrote the authors.

The researchers then looked prospectively at a third group of IPN patients who were admitted between January 2007 and December 2008. Group 3 was handled like group 2, with aggressive antibiotic treatment in an ICU as the primary treatment, followed by surgery if medical treatment failed. This third group included 27 patients with IPN (19 managed medically and 8 who had surgery).

Two patients died following surgery, whereas six died following medical treatment, for an overall mortality of 30% in group 3, which was similar to the overall mortality of group 2, "thus confirming the results of conservative management for IPN," wrote Dr. Garg and associates.

The researchers noted some limitations to their study, primarily that it was not randomized. "However, in the absence of convincing data about the success of conservative treatment for IPN, such a randomized trial would have been considered unethical and thus, perhaps was not possible," they added.

Dr. Garg and colleagues stated that they had no financial disclosures or conflicts of interest, and no financial support was declared for this study.

Among patients with infected pancreatic necrosis, both surgical necrosectomy and conservative treatment with antibiotics had comparable mortality rates, Dr. Pramod Kumar Garg and colleagues reported in the December issue of Clinical Gastroenterology and Hepatology.

However, over 10 years, the more conservatively managed patients had a better mortality rate than did the necrosectomy patients, the authors added.

"There has been no randomized comparative trial between conservative and surgical therapy in patients with IPN [infected pancreatic necrosis], primarily because conservative management was never considered a viable treatment option," wrote Dr. Garg of the department of gastroenterology at the All India Institute of Medical Sciences in New Delhi (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.04.011]).

He added that although "the present study has substantiated the emerging concept of primary conservative treatment in patients with infected pancreatic necrosis ... [it] in no way undermines the importance of surgery, preferably minimally invasive, in those patients who really merit surgical necrosectomy."

Dr. Garg and colleagues looked retrospectively at patients with infected pancreatic necrosis who were admitted to their facility in New Delhi. All cases were confirmed on culture.

Patients were divided into two groups. Group 1 was admitted between January 1997 and December 2002, and underwent surgery as their first, primary option, per hospital policy at the time. Patients who were not surgical candidates because of comorbid risk factors received conservative management.

There were 30 patients with IPN in this first group, 18 of whom had surgery after a median of 25 days and 12 of whom received conservative management.

Group 2 included patients who were admitted between January 2003 and December 2006. By this time, the institution’s protocol had changed to make aggressive medical treatment in an ICU – including combination antibiotics, organ support, intensive nutritional support, and percutaneous drainage, if required – the primary treatment. If medical treatment failed, patients underwent surgery.

This second group included 50 IPN patients, 40 of whom were managed conservatively and 10 of whom received open necrosectomy after a median of 47 days.

In group 1, the mortality rate for surgical patients was 66% (12 deaths) and 8% in the conservatively managed group (1 death), the authors reported. The difference was not statistically significant.

In group 2, 3 (33%) of the 10 patients who were treated surgically died, and of the 40 patients who were treated conservatively, 11 (28%) died. This difference did not reach statistical significance, either.

Overall, that translated to a mortality rate of 28% for group 2, compared with a rate of 43% in group 1, which also was not statistically significant.

"However, of the total 80 patients with IPN over the 10-year period, there was a significantly higher survival among patients treated medically [40 of 52 patients, or 77%] compared with those treated surgically [13 of 28 patients, or 46%]" (P = .005), wrote the authors.

The researchers then looked prospectively at a third group of IPN patients who were admitted between January 2007 and December 2008. Group 3 was handled like group 2, with aggressive antibiotic treatment in an ICU as the primary treatment, followed by surgery if medical treatment failed. This third group included 27 patients with IPN (19 managed medically and 8 who had surgery).

Two patients died following surgery, whereas six died following medical treatment, for an overall mortality of 30% in group 3, which was similar to the overall mortality of group 2, "thus confirming the results of conservative management for IPN," wrote Dr. Garg and associates.

The researchers noted some limitations to their study, primarily that it was not randomized. "However, in the absence of convincing data about the success of conservative treatment for IPN, such a randomized trial would have been considered unethical and thus, perhaps was not possible," they added.

Dr. Garg and colleagues stated that they had no financial disclosures or conflicts of interest, and no financial support was declared for this study.

Among patients with infected pancreatic necrosis, both surgical necrosectomy and conservative treatment with antibiotics had comparable mortality rates, Dr. Pramod Kumar Garg and colleagues reported in the December issue of Clinical Gastroenterology and Hepatology.

However, over 10 years, the more conservatively managed patients had a better mortality rate than did the necrosectomy patients, the authors added.

"There has been no randomized comparative trial between conservative and surgical therapy in patients with IPN [infected pancreatic necrosis], primarily because conservative management was never considered a viable treatment option," wrote Dr. Garg of the department of gastroenterology at the All India Institute of Medical Sciences in New Delhi (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.04.011]).

He added that although "the present study has substantiated the emerging concept of primary conservative treatment in patients with infected pancreatic necrosis ... [it] in no way undermines the importance of surgery, preferably minimally invasive, in those patients who really merit surgical necrosectomy."

Dr. Garg and colleagues looked retrospectively at patients with infected pancreatic necrosis who were admitted to their facility in New Delhi. All cases were confirmed on culture.

Patients were divided into two groups. Group 1 was admitted between January 1997 and December 2002, and underwent surgery as their first, primary option, per hospital policy at the time. Patients who were not surgical candidates because of comorbid risk factors received conservative management.

There were 30 patients with IPN in this first group, 18 of whom had surgery after a median of 25 days and 12 of whom received conservative management.

Group 2 included patients who were admitted between January 2003 and December 2006. By this time, the institution’s protocol had changed to make aggressive medical treatment in an ICU – including combination antibiotics, organ support, intensive nutritional support, and percutaneous drainage, if required – the primary treatment. If medical treatment failed, patients underwent surgery.

This second group included 50 IPN patients, 40 of whom were managed conservatively and 10 of whom received open necrosectomy after a median of 47 days.

In group 1, the mortality rate for surgical patients was 66% (12 deaths) and 8% in the conservatively managed group (1 death), the authors reported. The difference was not statistically significant.

In group 2, 3 (33%) of the 10 patients who were treated surgically died, and of the 40 patients who were treated conservatively, 11 (28%) died. This difference did not reach statistical significance, either.

Overall, that translated to a mortality rate of 28% for group 2, compared with a rate of 43% in group 1, which also was not statistically significant.

"However, of the total 80 patients with IPN over the 10-year period, there was a significantly higher survival among patients treated medically [40 of 52 patients, or 77%] compared with those treated surgically [13 of 28 patients, or 46%]" (P = .005), wrote the authors.

The researchers then looked prospectively at a third group of IPN patients who were admitted between January 2007 and December 2008. Group 3 was handled like group 2, with aggressive antibiotic treatment in an ICU as the primary treatment, followed by surgery if medical treatment failed. This third group included 27 patients with IPN (19 managed medically and 8 who had surgery).

Two patients died following surgery, whereas six died following medical treatment, for an overall mortality of 30% in group 3, which was similar to the overall mortality of group 2, "thus confirming the results of conservative management for IPN," wrote Dr. Garg and associates.

The researchers noted some limitations to their study, primarily that it was not randomized. "However, in the absence of convincing data about the success of conservative treatment for IPN, such a randomized trial would have been considered unethical and thus, perhaps was not possible," they added.

Dr. Garg and colleagues stated that they had no financial disclosures or conflicts of interest, and no financial support was declared for this study.

Among patients with infected pancreatic necrosis, both surgical necrosectomy and conservative treatment with antibiotics had comparable mortality rates, Dr. Pramod Kumar Garg and colleagues reported in the December issue of Clinical Gastroenterology and Hepatology.

However, over 10 years, the more conservatively managed patients had a better mortality rate than did the necrosectomy patients, the authors added.

"There has been no randomized comparative trial between conservative and surgical therapy in patients with IPN [infected pancreatic necrosis], primarily because conservative management was never considered a viable treatment option," wrote Dr. Garg of the department of gastroenterology at the All India Institute of Medical Sciences in New Delhi (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.04.011]).

He added that although "the present study has substantiated the emerging concept of primary conservative treatment in patients with infected pancreatic necrosis ... [it] in no way undermines the importance of surgery, preferably minimally invasive, in those patients who really merit surgical necrosectomy."

Dr. Garg and colleagues looked retrospectively at patients with infected pancreatic necrosis who were admitted to their facility in New Delhi. All cases were confirmed on culture.

Patients were divided into two groups. Group 1 was admitted between January 1997 and December 2002, and underwent surgery as their first, primary option, per hospital policy at the time. Patients who were not surgical candidates because of comorbid risk factors received conservative management.

There were 30 patients with IPN in this first group, 18 of whom had surgery after a median of 25 days and 12 of whom received conservative management.

Group 2 included patients who were admitted between January 2003 and December 2006. By this time, the institution’s protocol had changed to make aggressive medical treatment in an ICU – including combination antibiotics, organ support, intensive nutritional support, and percutaneous drainage, if required – the primary treatment. If medical treatment failed, patients underwent surgery.

This second group included 50 IPN patients, 40 of whom were managed conservatively and 10 of whom received open necrosectomy after a median of 47 days.

In group 1, the mortality rate for surgical patients was 66% (12 deaths) and 8% in the conservatively managed group (1 death), the authors reported. The difference was not statistically significant.

In group 2, 3 (33%) of the 10 patients who were treated surgically died, and of the 40 patients who were treated conservatively, 11 (28%) died. This difference did not reach statistical significance, either.

Overall, that translated to a mortality rate of 28% for group 2, compared with a rate of 43% in group 1, which also was not statistically significant.

"However, of the total 80 patients with IPN over the 10-year period, there was a significantly higher survival among patients treated medically [40 of 52 patients, or 77%] compared with those treated surgically [13 of 28 patients, or 46%]" (P = .005), wrote the authors.

The researchers then looked prospectively at a third group of IPN patients who were admitted between January 2007 and December 2008. Group 3 was handled like group 2, with aggressive antibiotic treatment in an ICU as the primary treatment, followed by surgery if medical treatment failed. This third group included 27 patients with IPN (19 managed medically and 8 who had surgery).

Two patients died following surgery, whereas six died following medical treatment, for an overall mortality of 30% in group 3, which was similar to the overall mortality of group 2, "thus confirming the results of conservative management for IPN," wrote Dr. Garg and associates.

The researchers noted some limitations to their study, primarily that it was not randomized. "However, in the absence of convincing data about the success of conservative treatment for IPN, such a randomized trial would have been considered unethical and thus, perhaps was not possible," they added.

Dr. Garg and colleagues stated that they had no financial disclosures or conflicts of interest, and no financial support was declared for this study.

Linaclotide was associated with significant improvement in symptoms of irritable bowel syndrome with constipation, including abdominal pain, within 1 week of starting therapy, Dr. Jeffrey M. Johnston and colleagues reported in the December issue of Gastroenterology.

However, diarrhea was a common side effect, leading to study withdrawal by more than a dozen patients.

Linaclotide is a novel, 14–amino acid peptide that binds to guanylate cyclase-C receptors on intestinal enterocytes, wrote Dr. Johnston, who is employed by the drug’s manufacturer, Ironwood Pharmaceuticals Inc.

In animal models, it has been shown to increase fluid secretion and transit, he added.

In the current study, Dr. Johnston and colleagues randomized 420 patients in a double-blind, placebo-controlled, phase IIB study. All patients were aged 18 years or older and met the Rome II criteria for irritable bowel syndrome (IBS). The mean patient age was 44 years, and 92% were female (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.041]).

All participants also reported having fewer than three spontaneous bowel movements per week, and at least one of the following symptoms occurring with 25% or more of their bowel movements: straining, lumpy or hard stools, or a sensation of incomplete evacuation.

Patients were randomized into five groups. One received a daily placebo, and the rest received once-daily linaclotide in doses of 75 mcg, 150 mcg, 300 mcg, or 600 mcg, taken orally before the first meal of the day.

According to daily assessments that were completed over the phone via an interactive voice-response system, all patients receiving active treatment who completed the study met the primary end point, which was an increase in complete spontaneous bowel movements (CSBMs), measured at 12 weeks, compared with baseline.

At week 12, the group receiving 75 mcg had an increase of 2.90 CSBMs per week; the 150-mcg group increased by 2.49 CSBMs per week; the 300-mcg group had an increase of 3.61 bowel movements per week; and the 600-mcg group increased by 2.68 CSBMs per week over their baseline (P less than or equal to .01 for all doses).

The group receiving placebo, in contrast, had a mean increase of 1.01 CSBM per week.

There were also significant decreases in abdominal pain – which was measured on a 5-point scale, with 1 signifying no pain and 5 being very severe pain – among patients taking linaclotide.

Compared with baseline, by 12 weeks the 75-mcg treatment group reported a mean reduction in the pain scale of 0.71 points, as did the 150-mcg group. The 300-mcg group had a reduction of 0.90 points, and the 600-mcg dosing group had a mean decrease of 0.86 points, compared with 0.49 points for placebo patients (P less than or equal to .05 for all doses).

Moreover, linaclotide’s effects "occurred within the first week of therapy and were sustained for the entire 3-month duration of this study," wrote the investigators.

The treatment was not without side effects. According to the researchers, the most frequent of these was diarrhea. They noted that the diarrhea was dose dependent, reported by 11.4%, 12.2%, 16.5%, and 18.0% of patients in the 75-, 150-, 300-, and 600-mcg dose groups, respectively, compared with 1.2% in the placebo group. "No dehydration, electrolyte changes, or other adverse clinical sequelae from diarrhea were reported," the authors wrote.

"Linaclotide resulted in sustained effects in the treatment of a common condition for which few therapies are currently available," concluded Dr. Johnston and associates.

The results of this placebo-controlled, dose-range–finding, phase IIB study "support further development of linaclotide for treatment of adults with [IBS constipation]".

Several of Dr. Johnston’s coinvestigators are also employees of linaclotide’s manufacturer, Ironwood Pharmaceuticals Inc., which also funded the study.

Linaclotide was associated with significant improvement in symptoms of irritable bowel syndrome with constipation, including abdominal pain, within 1 week of starting therapy, Dr. Jeffrey M. Johnston and colleagues reported in the December issue of Gastroenterology.

However, diarrhea was a common side effect, leading to study withdrawal by more than a dozen patients.

Linaclotide is a novel, 14–amino acid peptide that binds to guanylate cyclase-C receptors on intestinal enterocytes, wrote Dr. Johnston, who is employed by the drug’s manufacturer, Ironwood Pharmaceuticals Inc.

In animal models, it has been shown to increase fluid secretion and transit, he added.

In the current study, Dr. Johnston and colleagues randomized 420 patients in a double-blind, placebo-controlled, phase IIB study. All patients were aged 18 years or older and met the Rome II criteria for irritable bowel syndrome (IBS). The mean patient age was 44 years, and 92% were female (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.041]).

All participants also reported having fewer than three spontaneous bowel movements per week, and at least one of the following symptoms occurring with 25% or more of their bowel movements: straining, lumpy or hard stools, or a sensation of incomplete evacuation.

Patients were randomized into five groups. One received a daily placebo, and the rest received once-daily linaclotide in doses of 75 mcg, 150 mcg, 300 mcg, or 600 mcg, taken orally before the first meal of the day.

According to daily assessments that were completed over the phone via an interactive voice-response system, all patients receiving active treatment who completed the study met the primary end point, which was an increase in complete spontaneous bowel movements (CSBMs), measured at 12 weeks, compared with baseline.

At week 12, the group receiving 75 mcg had an increase of 2.90 CSBMs per week; the 150-mcg group increased by 2.49 CSBMs per week; the 300-mcg group had an increase of 3.61 bowel movements per week; and the 600-mcg group increased by 2.68 CSBMs per week over their baseline (P less than or equal to .01 for all doses).

The group receiving placebo, in contrast, had a mean increase of 1.01 CSBM per week.

There were also significant decreases in abdominal pain – which was measured on a 5-point scale, with 1 signifying no pain and 5 being very severe pain – among patients taking linaclotide.

Compared with baseline, by 12 weeks the 75-mcg treatment group reported a mean reduction in the pain scale of 0.71 points, as did the 150-mcg group. The 300-mcg group had a reduction of 0.90 points, and the 600-mcg dosing group had a mean decrease of 0.86 points, compared with 0.49 points for placebo patients (P less than or equal to .05 for all doses).

Moreover, linaclotide’s effects "occurred within the first week of therapy and were sustained for the entire 3-month duration of this study," wrote the investigators.

The treatment was not without side effects. According to the researchers, the most frequent of these was diarrhea. They noted that the diarrhea was dose dependent, reported by 11.4%, 12.2%, 16.5%, and 18.0% of patients in the 75-, 150-, 300-, and 600-mcg dose groups, respectively, compared with 1.2% in the placebo group. "No dehydration, electrolyte changes, or other adverse clinical sequelae from diarrhea were reported," the authors wrote.

"Linaclotide resulted in sustained effects in the treatment of a common condition for which few therapies are currently available," concluded Dr. Johnston and associates.

The results of this placebo-controlled, dose-range–finding, phase IIB study "support further development of linaclotide for treatment of adults with [IBS constipation]".

Several of Dr. Johnston’s coinvestigators are also employees of linaclotide’s manufacturer, Ironwood Pharmaceuticals Inc., which also funded the study.

Linaclotide was associated with significant improvement in symptoms of irritable bowel syndrome with constipation, including abdominal pain, within 1 week of starting therapy, Dr. Jeffrey M. Johnston and colleagues reported in the December issue of Gastroenterology.

However, diarrhea was a common side effect, leading to study withdrawal by more than a dozen patients.

Linaclotide is a novel, 14–amino acid peptide that binds to guanylate cyclase-C receptors on intestinal enterocytes, wrote Dr. Johnston, who is employed by the drug’s manufacturer, Ironwood Pharmaceuticals Inc.

In animal models, it has been shown to increase fluid secretion and transit, he added.

In the current study, Dr. Johnston and colleagues randomized 420 patients in a double-blind, placebo-controlled, phase IIB study. All patients were aged 18 years or older and met the Rome II criteria for irritable bowel syndrome (IBS). The mean patient age was 44 years, and 92% were female (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.041]).

All participants also reported having fewer than three spontaneous bowel movements per week, and at least one of the following symptoms occurring with 25% or more of their bowel movements: straining, lumpy or hard stools, or a sensation of incomplete evacuation.

Patients were randomized into five groups. One received a daily placebo, and the rest received once-daily linaclotide in doses of 75 mcg, 150 mcg, 300 mcg, or 600 mcg, taken orally before the first meal of the day.

According to daily assessments that were completed over the phone via an interactive voice-response system, all patients receiving active treatment who completed the study met the primary end point, which was an increase in complete spontaneous bowel movements (CSBMs), measured at 12 weeks, compared with baseline.

At week 12, the group receiving 75 mcg had an increase of 2.90 CSBMs per week; the 150-mcg group increased by 2.49 CSBMs per week; the 300-mcg group had an increase of 3.61 bowel movements per week; and the 600-mcg group increased by 2.68 CSBMs per week over their baseline (P less than or equal to .01 for all doses).

The group receiving placebo, in contrast, had a mean increase of 1.01 CSBM per week.

There were also significant decreases in abdominal pain – which was measured on a 5-point scale, with 1 signifying no pain and 5 being very severe pain – among patients taking linaclotide.

Compared with baseline, by 12 weeks the 75-mcg treatment group reported a mean reduction in the pain scale of 0.71 points, as did the 150-mcg group. The 300-mcg group had a reduction of 0.90 points, and the 600-mcg dosing group had a mean decrease of 0.86 points, compared with 0.49 points for placebo patients (P less than or equal to .05 for all doses).

Moreover, linaclotide’s effects "occurred within the first week of therapy and were sustained for the entire 3-month duration of this study," wrote the investigators.

The treatment was not without side effects. According to the researchers, the most frequent of these was diarrhea. They noted that the diarrhea was dose dependent, reported by 11.4%, 12.2%, 16.5%, and 18.0% of patients in the 75-, 150-, 300-, and 600-mcg dose groups, respectively, compared with 1.2% in the placebo group. "No dehydration, electrolyte changes, or other adverse clinical sequelae from diarrhea were reported," the authors wrote.

"Linaclotide resulted in sustained effects in the treatment of a common condition for which few therapies are currently available," concluded Dr. Johnston and associates.

The results of this placebo-controlled, dose-range–finding, phase IIB study "support further development of linaclotide for treatment of adults with [IBS constipation]".

Several of Dr. Johnston’s coinvestigators are also employees of linaclotide’s manufacturer, Ironwood Pharmaceuticals Inc., which also funded the study.

Linaclotide was associated with significant improvement in symptoms of irritable bowel syndrome with constipation, including abdominal pain, within 1 week of starting therapy, Dr. Jeffrey M. Johnston and colleagues reported in the December issue of Gastroenterology.

However, diarrhea was a common side effect, leading to study withdrawal by more than a dozen patients.

Linaclotide is a novel, 14–amino acid peptide that binds to guanylate cyclase-C receptors on intestinal enterocytes, wrote Dr. Johnston, who is employed by the drug’s manufacturer, Ironwood Pharmaceuticals Inc.

In animal models, it has been shown to increase fluid secretion and transit, he added.

In the current study, Dr. Johnston and colleagues randomized 420 patients in a double-blind, placebo-controlled, phase IIB study. All patients were aged 18 years or older and met the Rome II criteria for irritable bowel syndrome (IBS). The mean patient age was 44 years, and 92% were female (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.041]).

All participants also reported having fewer than three spontaneous bowel movements per week, and at least one of the following symptoms occurring with 25% or more of their bowel movements: straining, lumpy or hard stools, or a sensation of incomplete evacuation.

Patients were randomized into five groups. One received a daily placebo, and the rest received once-daily linaclotide in doses of 75 mcg, 150 mcg, 300 mcg, or 600 mcg, taken orally before the first meal of the day.

According to daily assessments that were completed over the phone via an interactive voice-response system, all patients receiving active treatment who completed the study met the primary end point, which was an increase in complete spontaneous bowel movements (CSBMs), measured at 12 weeks, compared with baseline.

At week 12, the group receiving 75 mcg had an increase of 2.90 CSBMs per week; the 150-mcg group increased by 2.49 CSBMs per week; the 300-mcg group had an increase of 3.61 bowel movements per week; and the 600-mcg group increased by 2.68 CSBMs per week over their baseline (P less than or equal to .01 for all doses).

The group receiving placebo, in contrast, had a mean increase of 1.01 CSBM per week.

There were also significant decreases in abdominal pain – which was measured on a 5-point scale, with 1 signifying no pain and 5 being very severe pain – among patients taking linaclotide.

Compared with baseline, by 12 weeks the 75-mcg treatment group reported a mean reduction in the pain scale of 0.71 points, as did the 150-mcg group. The 300-mcg group had a reduction of 0.90 points, and the 600-mcg dosing group had a mean decrease of 0.86 points, compared with 0.49 points for placebo patients (P less than or equal to .05 for all doses).

Moreover, linaclotide’s effects "occurred within the first week of therapy and were sustained for the entire 3-month duration of this study," wrote the investigators.

The treatment was not without side effects. According to the researchers, the most frequent of these was diarrhea. They noted that the diarrhea was dose dependent, reported by 11.4%, 12.2%, 16.5%, and 18.0% of patients in the 75-, 150-, 300-, and 600-mcg dose groups, respectively, compared with 1.2% in the placebo group. "No dehydration, electrolyte changes, or other adverse clinical sequelae from diarrhea were reported," the authors wrote.

"Linaclotide resulted in sustained effects in the treatment of a common condition for which few therapies are currently available," concluded Dr. Johnston and associates.

The results of this placebo-controlled, dose-range–finding, phase IIB study "support further development of linaclotide for treatment of adults with [IBS constipation]".

Several of Dr. Johnston’s coinvestigators are also employees of linaclotide’s manufacturer, Ironwood Pharmaceuticals Inc., which also funded the study.

Linaclotide was associated with significant improvement in symptoms of irritable bowel syndrome with constipation, including abdominal pain, within 1 week of starting therapy, Dr. Jeffrey M. Johnston and colleagues reported in the December issue of Gastroenterology.

However, diarrhea was a common side effect, leading to study withdrawal by more than a dozen patients.

Linaclotide is a novel, 14–amino acid peptide that binds to guanylate cyclase-C receptors on intestinal enterocytes, wrote Dr. Johnston, who is employed by the drug’s manufacturer, Ironwood Pharmaceuticals Inc.

In animal models, it has been shown to increase fluid secretion and transit, he added.

In the current study, Dr. Johnston and colleagues randomized 420 patients in a double-blind, placebo-controlled, phase IIB study. All patients were aged 18 years or older and met the Rome II criteria for irritable bowel syndrome (IBS). The mean patient age was 44 years, and 92% were female (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.041]).

All participants also reported having fewer than three spontaneous bowel movements per week, and at least one of the following symptoms occurring with 25% or more of their bowel movements: straining, lumpy or hard stools, or a sensation of incomplete evacuation.

Patients were randomized into five groups. One received a daily placebo, and the rest received once-daily linaclotide in doses of 75 mcg, 150 mcg, 300 mcg, or 600 mcg, taken orally before the first meal of the day.

According to daily assessments that were completed over the phone via an interactive voice-response system, all patients receiving active treatment who completed the study met the primary end point, which was an increase in complete spontaneous bowel movements (CSBMs), measured at 12 weeks, compared with baseline.

At week 12, the group receiving 75 mcg had an increase of 2.90 CSBMs per week; the 150-mcg group increased by 2.49 CSBMs per week; the 300-mcg group had an increase of 3.61 bowel movements per week; and the 600-mcg group increased by 2.68 CSBMs per week over their baseline (P less than or equal to .01 for all doses).

The group receiving placebo, in contrast, had a mean increase of 1.01 CSBM per week.

There were also significant decreases in abdominal pain – which was measured on a 5-point scale, with 1 signifying no pain and 5 being very severe pain – among patients taking linaclotide.

Compared with baseline, by 12 weeks the 75-mcg treatment group reported a mean reduction in the pain scale of 0.71 points, as did the 150-mcg group. The 300-mcg group had a reduction of 0.90 points, and the 600-mcg dosing group had a mean decrease of 0.86 points, compared with 0.49 points for placebo patients (P less than or equal to .05 for all doses).

Moreover, linaclotide’s effects "occurred within the first week of therapy and were sustained for the entire 3-month duration of this study," wrote the investigators.

The treatment was not without side effects. According to the researchers, the most frequent of these was diarrhea. They noted that the diarrhea was dose dependent, reported by 11.4%, 12.2%, 16.5%, and 18.0% of patients in the 75-, 150-, 300-, and 600-mcg dose groups, respectively, compared with 1.2% in the placebo group. "No dehydration, electrolyte changes, or other adverse clinical sequelae from diarrhea were reported," the authors wrote.

"Linaclotide resulted in sustained effects in the treatment of a common condition for which few therapies are currently available," concluded Dr. Johnston and associates.

The results of this placebo-controlled, dose-range–finding, phase IIB study "support further development of linaclotide for treatment of adults with [IBS constipation]".

Several of Dr. Johnston’s coinvestigators are also employees of linaclotide’s manufacturer, Ironwood Pharmaceuticals Inc., which also funded the study.

Linaclotide was associated with significant improvement in symptoms of irritable bowel syndrome with constipation, including abdominal pain, within 1 week of starting therapy, Dr. Jeffrey M. Johnston and colleagues reported in the December issue of Gastroenterology.

However, diarrhea was a common side effect, leading to study withdrawal by more than a dozen patients.

Linaclotide is a novel, 14–amino acid peptide that binds to guanylate cyclase-C receptors on intestinal enterocytes, wrote Dr. Johnston, who is employed by the drug’s manufacturer, Ironwood Pharmaceuticals Inc.

In animal models, it has been shown to increase fluid secretion and transit, he added.

In the current study, Dr. Johnston and colleagues randomized 420 patients in a double-blind, placebo-controlled, phase IIB study. All patients were aged 18 years or older and met the Rome II criteria for irritable bowel syndrome (IBS). The mean patient age was 44 years, and 92% were female (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.041]).

All participants also reported having fewer than three spontaneous bowel movements per week, and at least one of the following symptoms occurring with 25% or more of their bowel movements: straining, lumpy or hard stools, or a sensation of incomplete evacuation.

Patients were randomized into five groups. One received a daily placebo, and the rest received once-daily linaclotide in doses of 75 mcg, 150 mcg, 300 mcg, or 600 mcg, taken orally before the first meal of the day.

According to daily assessments that were completed over the phone via an interactive voice-response system, all patients receiving active treatment who completed the study met the primary end point, which was an increase in complete spontaneous bowel movements (CSBMs), measured at 12 weeks, compared with baseline.

At week 12, the group receiving 75 mcg had an increase of 2.90 CSBMs per week; the 150-mcg group increased by 2.49 CSBMs per week; the 300-mcg group had an increase of 3.61 bowel movements per week; and the 600-mcg group increased by 2.68 CSBMs per week over their baseline (P less than or equal to .01 for all doses).

The group receiving placebo, in contrast, had a mean increase of 1.01 CSBM per week.

There were also significant decreases in abdominal pain – which was measured on a 5-point scale, with 1 signifying no pain and 5 being very severe pain – among patients taking linaclotide.

Compared with baseline, by 12 weeks the 75-mcg treatment group reported a mean reduction in the pain scale of 0.71 points, as did the 150-mcg group. The 300-mcg group had a reduction of 0.90 points, and the 600-mcg dosing group had a mean decrease of 0.86 points, compared with 0.49 points for placebo patients (P less than or equal to .05 for all doses).

Moreover, linaclotide’s effects "occurred within the first week of therapy and were sustained for the entire 3-month duration of this study," wrote the investigators.

The treatment was not without side effects. According to the researchers, the most frequent of these was diarrhea. They noted that the diarrhea was dose dependent, reported by 11.4%, 12.2%, 16.5%, and 18.0% of patients in the 75-, 150-, 300-, and 600-mcg dose groups, respectively, compared with 1.2% in the placebo group. "No dehydration, electrolyte changes, or other adverse clinical sequelae from diarrhea were reported," the authors wrote.

"Linaclotide resulted in sustained effects in the treatment of a common condition for which few therapies are currently available," concluded Dr. Johnston and associates.

The results of this placebo-controlled, dose-range–finding, phase IIB study "support further development of linaclotide for treatment of adults with [IBS constipation]".

Several of Dr. Johnston’s coinvestigators are also employees of linaclotide’s manufacturer, Ironwood Pharmaceuticals Inc., which also funded the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Skin lesions led to discontinuation of anti–tumor necrosis factor-alpha therapy for inflammatory bowel disease in 34% of patients, reported Dr. Jean François Rahier and colleagues in the December issue of Clinical Gastroenterology and Hepatology.

Moreover, the occurrence of psoriasiform and eczematiform lesions associated with anti-TNF-alpha therapy was especially pronounced among patients with a previous history or family history of psoriasis or atopy.

Dr. Rahier of the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium, studied 85 patients with skin lesions and IBD who were seen at 35 gastroenterology centers in Belgium, France, Switzerland, and Austria.

A total of 69 patients had Crohn’s disease, 15 had ulcerative colitis, and 1 had indeterminate colitis. In all, 23 of the 85 patients were male. Data were collected using a standardized questionnaire. All cases were then reviewed simultaneously by a gastroenterologist and a dermatologist, wrote the authors (Clin. Gastroenterol. Hepatol. 2010 December [doi:10.1016/j.cgh.2010.07.022]).

Psoriasiform lesions (defined as well-delineated, scaly, erythematous plaques, as well as nail pitting, nail discoloration, and palmoplantar pustulosis) were observed in 62 patients. Their median age at the time of lesion development was 32 years, with a female: male ratio of 2:1.

"Fourteen patients (23%) had a previous history of psoriasis before treatment with any anti-TNF agent," wrote the authors. The remainder were diagnosed as having a "new onset of psoriasiform eruption," and among these, eight (17%) reported a history of familial psoriasis, two (4%) reported a history of familial atopy, and six (13%) reported a personal history of atopy.

Overall, 25 of these patients had a good response to topical treatment, whereas the remaining 37 patients had no response. In all, 16 of these nonresponders stopped anti-TNF treatment immediately because of their lesions.

The remaining 21 patients switched to another TNF antagonist; 7 of those patients discontinued this anti-TNF treatment as well. Two patients attempted a third anti-TNF agent, unsuccessfully.

That amounted to an overall discontinuation rate of 40% (25/62) because of psoriasiform skin lesions.

Eczematiform lesions (defined as xerosis and pruriginous, ill-limited plaques with erythematous or squamous macules or vesicles) were noted in 23 patients. The median age at the time of occurrence was 31 years, and the female:male ratio in this group was 6:7.

Of these patients, 10 (44%) had a history of atopy, and 13 were incident cases. Four of these incident cases (31%) had a familial history of atopy, one had a personal history of psoriasis, and one reported familial psoriasis.

A total of 16 patients (70%) had a good response to topical treatment of their lesions, and 7 (30%) had no response.

"Overall a definitive withdrawal of anti-TNF therapies due to uncontrolled [eczematiform] skin lesion was required in 4/23 (17%) patients," wrote the authors.

That equated to a total withdrawal among the entire population of 29 patients, or 34% of the study’s subjects.

The occurrence of lesions was not correlated with disease activity in the bowel. The authors noted that although the majority of lesions occurred in patients taking infliximab, compared with certolizumab or adalimumab, "this most probably reflects the earlier approval of this drug in Europe."

The authors also conceded that the true incidence of withdrawal may have been overstated in this population, since "this paper is a selected cohort of patients presenting with severe psoriasiform and eczematiform skin lesions seen in various centers."

Nevertheless, in light of the high rate of anti-TNF discontinuation shown in this study, they recommended that "all patients should be referred to a dermatologist for clinical evaluation and biopsy of skin lesions if indicated.

"Future research is needed to further explore epidemiological, clinical and fundamental aspects of this vexing paradoxical reaction," they added.

Dr. Rahier disclosed receiving lecture fees from Abbott Laboratories and Schering-Plough. Several other authors also disclosed financial relationships with pharmaceutical companies. They reported that they received no funding for the study.

Helicobacter pylori infection, chronic active gastritis, and intestinal metaplasia share similar epidemiologic patterns, and are significantly associated with each other, Dr. Amnon Sonnenberg and colleagues reported in an article appearing in the December issue of Gastroenterology.

Moreover, all three diagnoses are inversely associated with the presence of Barrett’s metaplasia, the researchers found.

Dr. Sonnenberg of the Portland (Ore.) VA Medical Center and Oregon Health and Science University, Portland, and colleagues looked at histology reports from 78,985 patients who had gastric and esophageal biopsies between April 2007 and March 2008. Patients were treated by approximately 1,500 gastroenterologists distributed throughout the United States (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.018]).

All samples were processed by Caris Life Sciences Inc., a gastrointestinal laboratory that works with private outpatient endoscopy centers, at facilities in Phoenix, Boston, and Irving, Tex.

The researchers found that patients who were positive for H. pylori infection had a startlingly high odds ratio for chronic active gastritis: 456 (95% confidence interval, 415-502). They were also twice as likely to have intestinal metaplasia (OR, 2.00; 95% CI, 1.87-2.14).

However, having H. pylori was apparently protective against a diagnosis of Barrett’s metaplasia, in the esophagus: The OR for having the latter among H. pylori-positive patients was 0.42 (95% CI, 0.36-0.50).

Similarly, patients who were histologically positive for chronic active gastritis were extremely likely to have H. pylori (OR, 457; 95% CI, 415-502), more than twice as likely to have intestinal metaplasia (OR, 2.10; 95% CI, 1.97-2.24), and roughly half as likely to have Barrett’s metaplasia (OR, 0.48; 95% CI, 0.41-0.56).

Finally, analyses linking intestinal metaplasia to these conditions revealed an OR of 2.07 for H. pylori (95% CI, 1.93-2.21), 2.15 for chronic active gastritis (95% CI, 2.02-2.29), and 0.61 for Barrett’s esophagus (95% CI, 0.51-0.72).

Dr. Sonnenberg and colleagues also found that all three diagnoses were more common among men than women, and that "compared with other insurance types, Medicaid was more common in patients with all three diagnoses."

Additionally, the researchers found that there was a higher concentration of all three diagnoses in Puerto Rico, New York, South Carolina, and New Mexico, compared with the rest of the country, possibly because of "an underlying variation in the socio-economic well-being among populations from different states," Dr. Sonnenberg noted.

According to the authors, although an inverse relationship between H. pylori–induced gastritis and Barrett’s esophagus has already been suggested in multiple studies, many of those analyses "were based on small population samples, clinical observations, or indirect evidence of opposing epidemiologic trends among H. pylori or peptic ulcer versus gastroesophageal reflux disease."

In contrast, the current study offers a "direct and inverse relationship between the histologic findings of Barrett’s mucosa and H. pylori–induced gastritis," they wrote.

"Using histological findings to assess the underlying epidemiology represents a new way to study epidemiologic patterns," they added.

However, the researchers conceded that the study was not without limitations. For one, it "lacks any data to assess the influence of H. pylori–induced gastritis on hyposecretion of acid," they wrote.

Moreover, "recent publications have indicated substantial misclassification of Barrett’s esophagus if only pathology reports are used," meaning that the prevalence of this condition could have been underestimated in this study.

Lead author Dr. Sonnenberg disclosed being supported by a grant from Takeda Pharmaceutical Co. Two other investigators are employees of Caris Life Sciences.

Helicobacter pylori infection, chronic active gastritis, and intestinal metaplasia share similar epidemiologic patterns, and are significantly associated with each other, Dr. Amnon Sonnenberg and colleagues reported in an article appearing in the December issue of Gastroenterology.

Moreover, all three diagnoses are inversely associated with the presence of Barrett’s metaplasia, the researchers found.

Dr. Sonnenberg of the Portland (Ore.) VA Medical Center and Oregon Health and Science University, Portland, and colleagues looked at histology reports from 78,985 patients who had gastric and esophageal biopsies between April 2007 and March 2008. Patients were treated by approximately 1,500 gastroenterologists distributed throughout the United States (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.018]).

All samples were processed by Caris Life Sciences Inc., a gastrointestinal laboratory that works with private outpatient endoscopy centers, at facilities in Phoenix, Boston, and Irving, Tex.

The researchers found that patients who were positive for H. pylori infection had a startlingly high odds ratio for chronic active gastritis: 456 (95% confidence interval, 415-502). They were also twice as likely to have intestinal metaplasia (OR, 2.00; 95% CI, 1.87-2.14).

However, having H. pylori was apparently protective against a diagnosis of Barrett’s metaplasia, in the esophagus: The OR for having the latter among H. pylori-positive patients was 0.42 (95% CI, 0.36-0.50).

Similarly, patients who were histologically positive for chronic active gastritis were extremely likely to have H. pylori (OR, 457; 95% CI, 415-502), more than twice as likely to have intestinal metaplasia (OR, 2.10; 95% CI, 1.97-2.24), and roughly half as likely to have Barrett’s metaplasia (OR, 0.48; 95% CI, 0.41-0.56).

Finally, analyses linking intestinal metaplasia to these conditions revealed an OR of 2.07 for H. pylori (95% CI, 1.93-2.21), 2.15 for chronic active gastritis (95% CI, 2.02-2.29), and 0.61 for Barrett’s esophagus (95% CI, 0.51-0.72).

Dr. Sonnenberg and colleagues also found that all three diagnoses were more common among men than women, and that "compared with other insurance types, Medicaid was more common in patients with all three diagnoses."

Additionally, the researchers found that there was a higher concentration of all three diagnoses in Puerto Rico, New York, South Carolina, and New Mexico, compared with the rest of the country, possibly because of "an underlying variation in the socio-economic well-being among populations from different states," Dr. Sonnenberg noted.

According to the authors, although an inverse relationship between H. pylori–induced gastritis and Barrett’s esophagus has already been suggested in multiple studies, many of those analyses "were based on small population samples, clinical observations, or indirect evidence of opposing epidemiologic trends among H. pylori or peptic ulcer versus gastroesophageal reflux disease."

In contrast, the current study offers a "direct and inverse relationship between the histologic findings of Barrett’s mucosa and H. pylori–induced gastritis," they wrote.

"Using histological findings to assess the underlying epidemiology represents a new way to study epidemiologic patterns," they added.

However, the researchers conceded that the study was not without limitations. For one, it "lacks any data to assess the influence of H. pylori–induced gastritis on hyposecretion of acid," they wrote.

Moreover, "recent publications have indicated substantial misclassification of Barrett’s esophagus if only pathology reports are used," meaning that the prevalence of this condition could have been underestimated in this study.

Lead author Dr. Sonnenberg disclosed being supported by a grant from Takeda Pharmaceutical Co. Two other investigators are employees of Caris Life Sciences.

Helicobacter pylori infection, chronic active gastritis, and intestinal metaplasia share similar epidemiologic patterns, and are significantly associated with each other, Dr. Amnon Sonnenberg and colleagues reported in an article appearing in the December issue of Gastroenterology.

Moreover, all three diagnoses are inversely associated with the presence of Barrett’s metaplasia, the researchers found.

Dr. Sonnenberg of the Portland (Ore.) VA Medical Center and Oregon Health and Science University, Portland, and colleagues looked at histology reports from 78,985 patients who had gastric and esophageal biopsies between April 2007 and March 2008. Patients were treated by approximately 1,500 gastroenterologists distributed throughout the United States (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.018]).

All samples were processed by Caris Life Sciences Inc., a gastrointestinal laboratory that works with private outpatient endoscopy centers, at facilities in Phoenix, Boston, and Irving, Tex.

The researchers found that patients who were positive for H. pylori infection had a startlingly high odds ratio for chronic active gastritis: 456 (95% confidence interval, 415-502). They were also twice as likely to have intestinal metaplasia (OR, 2.00; 95% CI, 1.87-2.14).

However, having H. pylori was apparently protective against a diagnosis of Barrett’s metaplasia, in the esophagus: The OR for having the latter among H. pylori-positive patients was 0.42 (95% CI, 0.36-0.50).

Similarly, patients who were histologically positive for chronic active gastritis were extremely likely to have H. pylori (OR, 457; 95% CI, 415-502), more than twice as likely to have intestinal metaplasia (OR, 2.10; 95% CI, 1.97-2.24), and roughly half as likely to have Barrett’s metaplasia (OR, 0.48; 95% CI, 0.41-0.56).

Finally, analyses linking intestinal metaplasia to these conditions revealed an OR of 2.07 for H. pylori (95% CI, 1.93-2.21), 2.15 for chronic active gastritis (95% CI, 2.02-2.29), and 0.61 for Barrett’s esophagus (95% CI, 0.51-0.72).

Dr. Sonnenberg and colleagues also found that all three diagnoses were more common among men than women, and that "compared with other insurance types, Medicaid was more common in patients with all three diagnoses."

Additionally, the researchers found that there was a higher concentration of all three diagnoses in Puerto Rico, New York, South Carolina, and New Mexico, compared with the rest of the country, possibly because of "an underlying variation in the socio-economic well-being among populations from different states," Dr. Sonnenberg noted.

According to the authors, although an inverse relationship between H. pylori–induced gastritis and Barrett’s esophagus has already been suggested in multiple studies, many of those analyses "were based on small population samples, clinical observations, or indirect evidence of opposing epidemiologic trends among H. pylori or peptic ulcer versus gastroesophageal reflux disease."

In contrast, the current study offers a "direct and inverse relationship between the histologic findings of Barrett’s mucosa and H. pylori–induced gastritis," they wrote.

"Using histological findings to assess the underlying epidemiology represents a new way to study epidemiologic patterns," they added.

However, the researchers conceded that the study was not without limitations. For one, it "lacks any data to assess the influence of H. pylori–induced gastritis on hyposecretion of acid," they wrote.

Moreover, "recent publications have indicated substantial misclassification of Barrett’s esophagus if only pathology reports are used," meaning that the prevalence of this condition could have been underestimated in this study.

Lead author Dr. Sonnenberg disclosed being supported by a grant from Takeda Pharmaceutical Co. Two other investigators are employees of Caris Life Sciences.

Helicobacter pylori infection, chronic active gastritis, and intestinal metaplasia share similar epidemiologic patterns, and are significantly associated with each other, Dr. Amnon Sonnenberg and colleagues reported in an article appearing in the December issue of Gastroenterology.

Moreover, all three diagnoses are inversely associated with the presence of Barrett’s metaplasia, the researchers found.

Dr. Sonnenberg of the Portland (Ore.) VA Medical Center and Oregon Health and Science University, Portland, and colleagues looked at histology reports from 78,985 patients who had gastric and esophageal biopsies between April 2007 and March 2008. Patients were treated by approximately 1,500 gastroenterologists distributed throughout the United States (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.018]).

All samples were processed by Caris Life Sciences Inc., a gastrointestinal laboratory that works with private outpatient endoscopy centers, at facilities in Phoenix, Boston, and Irving, Tex.

The researchers found that patients who were positive for H. pylori infection had a startlingly high odds ratio for chronic active gastritis: 456 (95% confidence interval, 415-502). They were also twice as likely to have intestinal metaplasia (OR, 2.00; 95% CI, 1.87-2.14).

However, having H. pylori was apparently protective against a diagnosis of Barrett’s metaplasia, in the esophagus: The OR for having the latter among H. pylori-positive patients was 0.42 (95% CI, 0.36-0.50).

Similarly, patients who were histologically positive for chronic active gastritis were extremely likely to have H. pylori (OR, 457; 95% CI, 415-502), more than twice as likely to have intestinal metaplasia (OR, 2.10; 95% CI, 1.97-2.24), and roughly half as likely to have Barrett’s metaplasia (OR, 0.48; 95% CI, 0.41-0.56).

Finally, analyses linking intestinal metaplasia to these conditions revealed an OR of 2.07 for H. pylori (95% CI, 1.93-2.21), 2.15 for chronic active gastritis (95% CI, 2.02-2.29), and 0.61 for Barrett’s esophagus (95% CI, 0.51-0.72).

Dr. Sonnenberg and colleagues also found that all three diagnoses were more common among men than women, and that "compared with other insurance types, Medicaid was more common in patients with all three diagnoses."

Additionally, the researchers found that there was a higher concentration of all three diagnoses in Puerto Rico, New York, South Carolina, and New Mexico, compared with the rest of the country, possibly because of "an underlying variation in the socio-economic well-being among populations from different states," Dr. Sonnenberg noted.

According to the authors, although an inverse relationship between H. pylori–induced gastritis and Barrett’s esophagus has already been suggested in multiple studies, many of those analyses "were based on small population samples, clinical observations, or indirect evidence of opposing epidemiologic trends among H. pylori or peptic ulcer versus gastroesophageal reflux disease."

In contrast, the current study offers a "direct and inverse relationship between the histologic findings of Barrett’s mucosa and H. pylori–induced gastritis," they wrote.

"Using histological findings to assess the underlying epidemiology represents a new way to study epidemiologic patterns," they added.

However, the researchers conceded that the study was not without limitations. For one, it "lacks any data to assess the influence of H. pylori–induced gastritis on hyposecretion of acid," they wrote.

Moreover, "recent publications have indicated substantial misclassification of Barrett’s esophagus if only pathology reports are used," meaning that the prevalence of this condition could have been underestimated in this study.

Lead author Dr. Sonnenberg disclosed being supported by a grant from Takeda Pharmaceutical Co. Two other investigators are employees of Caris Life Sciences.

Helicobacter pylori infection, chronic active gastritis, and intestinal metaplasia share similar epidemiologic patterns, and are significantly associated with each other, Dr. Amnon Sonnenberg and colleagues reported in an article appearing in the December issue of Gastroenterology.

Moreover, all three diagnoses are inversely associated with the presence of Barrett’s metaplasia, the researchers found.

Dr. Sonnenberg of the Portland (Ore.) VA Medical Center and Oregon Health and Science University, Portland, and colleagues looked at histology reports from 78,985 patients who had gastric and esophageal biopsies between April 2007 and March 2008. Patients were treated by approximately 1,500 gastroenterologists distributed throughout the United States (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.018]).

All samples were processed by Caris Life Sciences Inc., a gastrointestinal laboratory that works with private outpatient endoscopy centers, at facilities in Phoenix, Boston, and Irving, Tex.

The researchers found that patients who were positive for H. pylori infection had a startlingly high odds ratio for chronic active gastritis: 456 (95% confidence interval, 415-502). They were also twice as likely to have intestinal metaplasia (OR, 2.00; 95% CI, 1.87-2.14).

However, having H. pylori was apparently protective against a diagnosis of Barrett’s metaplasia, in the esophagus: The OR for having the latter among H. pylori-positive patients was 0.42 (95% CI, 0.36-0.50).

Similarly, patients who were histologically positive for chronic active gastritis were extremely likely to have H. pylori (OR, 457; 95% CI, 415-502), more than twice as likely to have intestinal metaplasia (OR, 2.10; 95% CI, 1.97-2.24), and roughly half as likely to have Barrett’s metaplasia (OR, 0.48; 95% CI, 0.41-0.56).

Finally, analyses linking intestinal metaplasia to these conditions revealed an OR of 2.07 for H. pylori (95% CI, 1.93-2.21), 2.15 for chronic active gastritis (95% CI, 2.02-2.29), and 0.61 for Barrett’s esophagus (95% CI, 0.51-0.72).

Dr. Sonnenberg and colleagues also found that all three diagnoses were more common among men than women, and that "compared with other insurance types, Medicaid was more common in patients with all three diagnoses."

Additionally, the researchers found that there was a higher concentration of all three diagnoses in Puerto Rico, New York, South Carolina, and New Mexico, compared with the rest of the country, possibly because of "an underlying variation in the socio-economic well-being among populations from different states," Dr. Sonnenberg noted.

According to the authors, although an inverse relationship between H. pylori–induced gastritis and Barrett’s esophagus has already been suggested in multiple studies, many of those analyses "were based on small population samples, clinical observations, or indirect evidence of opposing epidemiologic trends among H. pylori or peptic ulcer versus gastroesophageal reflux disease."

In contrast, the current study offers a "direct and inverse relationship between the histologic findings of Barrett’s mucosa and H. pylori–induced gastritis," they wrote.

"Using histological findings to assess the underlying epidemiology represents a new way to study epidemiologic patterns," they added.

However, the researchers conceded that the study was not without limitations. For one, it "lacks any data to assess the influence of H. pylori–induced gastritis on hyposecretion of acid," they wrote.

Moreover, "recent publications have indicated substantial misclassification of Barrett’s esophagus if only pathology reports are used," meaning that the prevalence of this condition could have been underestimated in this study.

Lead author Dr. Sonnenberg disclosed being supported by a grant from Takeda Pharmaceutical Co. Two other investigators are employees of Caris Life Sciences.

Helicobacter pylori infection, chronic active gastritis, and intestinal metaplasia share similar epidemiologic patterns, and are significantly associated with each other, Dr. Amnon Sonnenberg and colleagues reported in an article appearing in the December issue of Gastroenterology.

Moreover, all three diagnoses are inversely associated with the presence of Barrett’s metaplasia, the researchers found.

Dr. Sonnenberg of the Portland (Ore.) VA Medical Center and Oregon Health and Science University, Portland, and colleagues looked at histology reports from 78,985 patients who had gastric and esophageal biopsies between April 2007 and March 2008. Patients were treated by approximately 1,500 gastroenterologists distributed throughout the United States (Gastroenterology 2010 December [doi:10.1053/j.gastro.2010.08.018]).

All samples were processed by Caris Life Sciences Inc., a gastrointestinal laboratory that works with private outpatient endoscopy centers, at facilities in Phoenix, Boston, and Irving, Tex.

The researchers found that patients who were positive for H. pylori infection had a startlingly high odds ratio for chronic active gastritis: 456 (95% confidence interval, 415-502). They were also twice as likely to have intestinal metaplasia (OR, 2.00; 95% CI, 1.87-2.14).

However, having H. pylori was apparently protective against a diagnosis of Barrett’s metaplasia, in the esophagus: The OR for having the latter among H. pylori-positive patients was 0.42 (95% CI, 0.36-0.50).

Similarly, patients who were histologically positive for chronic active gastritis were extremely likely to have H. pylori (OR, 457; 95% CI, 415-502), more than twice as likely to have intestinal metaplasia (OR, 2.10; 95% CI, 1.97-2.24), and roughly half as likely to have Barrett’s metaplasia (OR, 0.48; 95% CI, 0.41-0.56).

Finally, analyses linking intestinal metaplasia to these conditions revealed an OR of 2.07 for H. pylori (95% CI, 1.93-2.21), 2.15 for chronic active gastritis (95% CI, 2.02-2.29), and 0.61 for Barrett’s esophagus (95% CI, 0.51-0.72).

Dr. Sonnenberg and colleagues also found that all three diagnoses were more common among men than women, and that "compared with other insurance types, Medicaid was more common in patients with all three diagnoses."

Additionally, the researchers found that there was a higher concentration of all three diagnoses in Puerto Rico, New York, South Carolina, and New Mexico, compared with the rest of the country, possibly because of "an underlying variation in the socio-economic well-being among populations from different states," Dr. Sonnenberg noted.

According to the authors, although an inverse relationship between H. pylori–induced gastritis and Barrett’s esophagus has already been suggested in multiple studies, many of those analyses "were based on small population samples, clinical observations, or indirect evidence of opposing epidemiologic trends among H. pylori or peptic ulcer versus gastroesophageal reflux disease."

In contrast, the current study offers a "direct and inverse relationship between the histologic findings of Barrett’s mucosa and H. pylori–induced gastritis," they wrote.

"Using histological findings to assess the underlying epidemiology represents a new way to study epidemiologic patterns," they added.

However, the researchers conceded that the study was not without limitations. For one, it "lacks any data to assess the influence of H. pylori–induced gastritis on hyposecretion of acid," they wrote.

Moreover, "recent publications have indicated substantial misclassification of Barrett’s esophagus if only pathology reports are used," meaning that the prevalence of this condition could have been underestimated in this study.

Lead author Dr. Sonnenberg disclosed being supported by a grant from Takeda Pharmaceutical Co. Two other investigators are employees of Caris Life Sciences.

Since the launch of the new “blue button” on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians' groups and patients are calling for this practice to be commonplace for all.

“If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they're empowered to make better decisions,” said Dr. Steven Waldren, director of the American Academy of Family Physicians' Center for Health Information Technology. “The blue button initiative is saying, 'Let's get started.'”

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a “a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust,” according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House's Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.govwww.myhealth.va.gov

“This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy,” Mr. Park wrote. “Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers.”

Now, many physicians and physician groups want to see the concept of downloadable personal health records extended to all of their patients.

A policy paper on the topic published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on “organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information.”

Additionally, the paper recommended making the download capability a “core procurement requirement for federal- and state-sponsored health [information technology] grants and projects” that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation's paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based “apps” (applications), which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient's downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. “Those are the things that can start to happen,” with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, “Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download.”

Dr. Waldren agreed. “There's no question that privacy and security are real issues,” he said. And that means not only keeping the site secure, but educating patients, too.

“Every time the patient clicks on that blue button, they need to be reminded, 'You're doing something that puts your information at risk,'” he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

“I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately,” he said. “But it's never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality.”

The Markle Foundation's paper, “The Download Capability,” is available at www.markle.org/downloadable_assets/20100831_dlcapability.pdf

Patients who can access their records “are more engaged in their care.”

Source ©Crystal Kirk/Fotolia.com

Since the launch of the new “blue button” on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians' groups and patients are calling for this practice to be commonplace for all.

“If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they're empowered to make better decisions,” said Dr. Steven Waldren, director of the American Academy of Family Physicians' Center for Health Information Technology. “The blue button initiative is saying, 'Let's get started.'”

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a “a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust,” according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House's Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.govwww.myhealth.va.gov

“This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy,” Mr. Park wrote. “Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers.”

Now, many physicians and physician groups want to see the concept of downloadable personal health records extended to all of their patients.

A policy paper on the topic published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on “organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information.”

Additionally, the paper recommended making the download capability a “core procurement requirement for federal- and state-sponsored health [information technology] grants and projects” that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation's paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based “apps” (applications), which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient's downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. “Those are the things that can start to happen,” with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, “Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download.”

Dr. Waldren agreed. “There's no question that privacy and security are real issues,” he said. And that means not only keeping the site secure, but educating patients, too.

“Every time the patient clicks on that blue button, they need to be reminded, 'You're doing something that puts your information at risk,'” he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

“I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately,” he said. “But it's never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality.”

The Markle Foundation's paper, “The Download Capability,” is available at www.markle.org/downloadable_assets/20100831_dlcapability.pdf

Patients who can access their records “are more engaged in their care.”

Source ©Crystal Kirk/Fotolia.com

Since the launch of the new “blue button” on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians' groups and patients are calling for this practice to be commonplace for all.

“If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they're empowered to make better decisions,” said Dr. Steven Waldren, director of the American Academy of Family Physicians' Center for Health Information Technology. “The blue button initiative is saying, 'Let's get started.'”

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a “a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust,” according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House's Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.govwww.myhealth.va.gov

“This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy,” Mr. Park wrote. “Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers.”

Now, many physicians and physician groups want to see the concept of downloadable personal health records extended to all of their patients.

A policy paper on the topic published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on “organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information.”

Additionally, the paper recommended making the download capability a “core procurement requirement for federal- and state-sponsored health [information technology] grants and projects” that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation's paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based “apps” (applications), which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient's downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. “Those are the things that can start to happen,” with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, “Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download.”

Dr. Waldren agreed. “There's no question that privacy and security are real issues,” he said. And that means not only keeping the site secure, but educating patients, too.

“Every time the patient clicks on that blue button, they need to be reminded, 'You're doing something that puts your information at risk,'” he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

“I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately,” he said. “But it's never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality.”

The Markle Foundation's paper, “The Download Capability,” is available at www.markle.org/downloadable_assets/20100831_dlcapability.pdf

Patients who can access their records “are more engaged in their care.”

Source ©Crystal Kirk/Fotolia.com