Digestive Disease Week (DDW 2011)

CHICAGO – A randomized, multicenter open-label trial found that cyclosporine was not more effective than infliximab in patients with acute, severe ulcerative colitis refractory to intravenous steroids, according to Dr. David Laharie.

Acute severe ulcerative colitis (UC) occurs in about 25% of patients with UC, and while intravenous corticosteroids are the primary therapy, 40% of patients are refractory to them. After steroid failure, only two medical options are available to avoid colectomy: cyclosporine and infliximab.

"However, there has been no randomized clinical trial comparing the two," said Dr. Laharie of Centre Hospitalier Universitaire in Bordeaux, France. He presented the findings of a multicenter, randomized open-label study comparing cyclosporine with infliximab in severe acute UC refractory to intravenous steroids. This study found cyclosporine to be no more effective than infliximab in this population, he said at the annual Digestive Disease Week.

Patients with steroid-refractory acute severe UC were randomized to cyclosporine (55 patients) or infliximab (56 patients). The researchers sought to determine whether treatment failure was less frequent with cyclosporine than with infliximab.

Adults were randomized if they were having a severe acute flare of UC (Lichtiger score greater than 10) and were refractory to intravenous steroid therapy (greater than or equal to 0.8 mg/kg per day of methylprednisone or equivalent) for at least 5 days. They had to be naive to the two treatment drugs and could not be under treatment with azathioprine/6-mercaptopurine unless therapy had been initiated fewer than 4 weeks before randomization.

The two groups were treated for up to 98 days, and the trial’s primary end point was treatment failure, defined as an absence of early clinical response, relapse after day 7, colectomy, absence of remission off steroids at the trial’s end, a severe adverse event, or death. Secondary end points included the Lichtiger score from day 0 to day 7, the percentage of patients showing clinical response at day 7, endoscopic response and colectomy at day 98, and the number of severe adverse events.

Approximately half the patients in both groups were female, with a median age of approximately 37 years, and had UC for at least 1 year. More than 90% of patients in both groups were naive to azathioprine. Lichtiger scores in both groups were 11 and over, and Mayo scores ranged from less than or equal to 0 to 12.

For the primary end point of treatment failure, 60% failed in the cyclosporine arm versus 54% in the infliximab arm, a nonsignificant difference.

The response rate at day 7 was 85.4% in the cyclosporine arm versus 85.7% in the infliximab arm, also not a significant difference. Response was defined as a Lichtiger score less than 10, and a decrease of at least 3 points compared with baseline.

The Lichtiger score from day 0 to day 6 showed that the median time to clinical response was 4 days (interquartile range [IQR], 3-6) with infliximab, versus 5 days (IQR, 4-7) for cyclosporine, a significant difference (P = .046).

At day 98, signs of mucosal healing were found in 52% of patients in the cyclosporine group and 53% of patients in the infliximab group. Healing was defined as having a Mayo endoscopic subscore of 0-1.

The colectomy rates were 18% in the cyclosporine arm and 21% in the infliximab arm. Severe adverse events affected 15% (8 patients) in the cyclosporine group and 25% (14 patients) in the infliximab group. Three patients developed cytomegalovirus colitis and two developed septicemia.

"In acute severe ulcerative colitis refractory to intravenous steroids, cyclosporine was not more effective than infliximab," said Dr. Laharie. "The short-term response was achieved with both drugs in more than 80% of patients within 1 week. Three-month colectomy rates were similar (18% with cyclosporine versus 21% with infliximab). And in this severe population, both drugs were well tolerated," he said.

Dr. Laharie disclosed financial relationships with Schering-Plough and Abbott Laboratories (royalty, speaking, and teaching), and with Norgine (consulting fee and board membership). The study received support from the Association François Aupetit, the Société Nationale Française de Gastro-Entérologie, and the International Organization for the Study of Inflammatory Bowel Disease, and was sponsored by Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif.

CHICAGO – A randomized, multicenter open-label trial found that cyclosporine was not more effective than infliximab in patients with acute, severe ulcerative colitis refractory to intravenous steroids, according to Dr. David Laharie.

Acute severe ulcerative colitis (UC) occurs in about 25% of patients with UC, and while intravenous corticosteroids are the primary therapy, 40% of patients are refractory to them. After steroid failure, only two medical options are available to avoid colectomy: cyclosporine and infliximab.

"However, there has been no randomized clinical trial comparing the two," said Dr. Laharie of Centre Hospitalier Universitaire in Bordeaux, France. He presented the findings of a multicenter, randomized open-label study comparing cyclosporine with infliximab in severe acute UC refractory to intravenous steroids. This study found cyclosporine to be no more effective than infliximab in this population, he said at the annual Digestive Disease Week.

Patients with steroid-refractory acute severe UC were randomized to cyclosporine (55 patients) or infliximab (56 patients). The researchers sought to determine whether treatment failure was less frequent with cyclosporine than with infliximab.

Adults were randomized if they were having a severe acute flare of UC (Lichtiger score greater than 10) and were refractory to intravenous steroid therapy (greater than or equal to 0.8 mg/kg per day of methylprednisone or equivalent) for at least 5 days. They had to be naive to the two treatment drugs and could not be under treatment with azathioprine/6-mercaptopurine unless therapy had been initiated fewer than 4 weeks before randomization.

The two groups were treated for up to 98 days, and the trial’s primary end point was treatment failure, defined as an absence of early clinical response, relapse after day 7, colectomy, absence of remission off steroids at the trial’s end, a severe adverse event, or death. Secondary end points included the Lichtiger score from day 0 to day 7, the percentage of patients showing clinical response at day 7, endoscopic response and colectomy at day 98, and the number of severe adverse events.

Approximately half the patients in both groups were female, with a median age of approximately 37 years, and had UC for at least 1 year. More than 90% of patients in both groups were naive to azathioprine. Lichtiger scores in both groups were 11 and over, and Mayo scores ranged from less than or equal to 0 to 12.

For the primary end point of treatment failure, 60% failed in the cyclosporine arm versus 54% in the infliximab arm, a nonsignificant difference.

The response rate at day 7 was 85.4% in the cyclosporine arm versus 85.7% in the infliximab arm, also not a significant difference. Response was defined as a Lichtiger score less than 10, and a decrease of at least 3 points compared with baseline.

The Lichtiger score from day 0 to day 6 showed that the median time to clinical response was 4 days (interquartile range [IQR], 3-6) with infliximab, versus 5 days (IQR, 4-7) for cyclosporine, a significant difference (P = .046).

At day 98, signs of mucosal healing were found in 52% of patients in the cyclosporine group and 53% of patients in the infliximab group. Healing was defined as having a Mayo endoscopic subscore of 0-1.

The colectomy rates were 18% in the cyclosporine arm and 21% in the infliximab arm. Severe adverse events affected 15% (8 patients) in the cyclosporine group and 25% (14 patients) in the infliximab group. Three patients developed cytomegalovirus colitis and two developed septicemia.

"In acute severe ulcerative colitis refractory to intravenous steroids, cyclosporine was not more effective than infliximab," said Dr. Laharie. "The short-term response was achieved with both drugs in more than 80% of patients within 1 week. Three-month colectomy rates were similar (18% with cyclosporine versus 21% with infliximab). And in this severe population, both drugs were well tolerated," he said.

Dr. Laharie disclosed financial relationships with Schering-Plough and Abbott Laboratories (royalty, speaking, and teaching), and with Norgine (consulting fee and board membership). The study received support from the Association François Aupetit, the Société Nationale Française de Gastro-Entérologie, and the International Organization for the Study of Inflammatory Bowel Disease, and was sponsored by Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif.

CHICAGO – A randomized, multicenter open-label trial found that cyclosporine was not more effective than infliximab in patients with acute, severe ulcerative colitis refractory to intravenous steroids, according to Dr. David Laharie.

Acute severe ulcerative colitis (UC) occurs in about 25% of patients with UC, and while intravenous corticosteroids are the primary therapy, 40% of patients are refractory to them. After steroid failure, only two medical options are available to avoid colectomy: cyclosporine and infliximab.

"However, there has been no randomized clinical trial comparing the two," said Dr. Laharie of Centre Hospitalier Universitaire in Bordeaux, France. He presented the findings of a multicenter, randomized open-label study comparing cyclosporine with infliximab in severe acute UC refractory to intravenous steroids. This study found cyclosporine to be no more effective than infliximab in this population, he said at the annual Digestive Disease Week.

Patients with steroid-refractory acute severe UC were randomized to cyclosporine (55 patients) or infliximab (56 patients). The researchers sought to determine whether treatment failure was less frequent with cyclosporine than with infliximab.

Adults were randomized if they were having a severe acute flare of UC (Lichtiger score greater than 10) and were refractory to intravenous steroid therapy (greater than or equal to 0.8 mg/kg per day of methylprednisone or equivalent) for at least 5 days. They had to be naive to the two treatment drugs and could not be under treatment with azathioprine/6-mercaptopurine unless therapy had been initiated fewer than 4 weeks before randomization.

The two groups were treated for up to 98 days, and the trial’s primary end point was treatment failure, defined as an absence of early clinical response, relapse after day 7, colectomy, absence of remission off steroids at the trial’s end, a severe adverse event, or death. Secondary end points included the Lichtiger score from day 0 to day 7, the percentage of patients showing clinical response at day 7, endoscopic response and colectomy at day 98, and the number of severe adverse events.

Approximately half the patients in both groups were female, with a median age of approximately 37 years, and had UC for at least 1 year. More than 90% of patients in both groups were naive to azathioprine. Lichtiger scores in both groups were 11 and over, and Mayo scores ranged from less than or equal to 0 to 12.

For the primary end point of treatment failure, 60% failed in the cyclosporine arm versus 54% in the infliximab arm, a nonsignificant difference.

The response rate at day 7 was 85.4% in the cyclosporine arm versus 85.7% in the infliximab arm, also not a significant difference. Response was defined as a Lichtiger score less than 10, and a decrease of at least 3 points compared with baseline.

The Lichtiger score from day 0 to day 6 showed that the median time to clinical response was 4 days (interquartile range [IQR], 3-6) with infliximab, versus 5 days (IQR, 4-7) for cyclosporine, a significant difference (P = .046).

At day 98, signs of mucosal healing were found in 52% of patients in the cyclosporine group and 53% of patients in the infliximab group. Healing was defined as having a Mayo endoscopic subscore of 0-1.

The colectomy rates were 18% in the cyclosporine arm and 21% in the infliximab arm. Severe adverse events affected 15% (8 patients) in the cyclosporine group and 25% (14 patients) in the infliximab group. Three patients developed cytomegalovirus colitis and two developed septicemia.

"In acute severe ulcerative colitis refractory to intravenous steroids, cyclosporine was not more effective than infliximab," said Dr. Laharie. "The short-term response was achieved with both drugs in more than 80% of patients within 1 week. Three-month colectomy rates were similar (18% with cyclosporine versus 21% with infliximab). And in this severe population, both drugs were well tolerated," he said.

Dr. Laharie disclosed financial relationships with Schering-Plough and Abbott Laboratories (royalty, speaking, and teaching), and with Norgine (consulting fee and board membership). The study received support from the Association François Aupetit, the Société Nationale Française de Gastro-Entérologie, and the International Organization for the Study of Inflammatory Bowel Disease, and was sponsored by Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif.

CHICAGO – A randomized, multicenter open-label trial found that cyclosporine was not more effective than infliximab in patients with acute, severe ulcerative colitis refractory to intravenous steroids, according to Dr. David Laharie.

Acute severe ulcerative colitis (UC) occurs in about 25% of patients with UC, and while intravenous corticosteroids are the primary therapy, 40% of patients are refractory to them. After steroid failure, only two medical options are available to avoid colectomy: cyclosporine and infliximab.

"However, there has been no randomized clinical trial comparing the two," said Dr. Laharie of Centre Hospitalier Universitaire in Bordeaux, France. He presented the findings of a multicenter, randomized open-label study comparing cyclosporine with infliximab in severe acute UC refractory to intravenous steroids. This study found cyclosporine to be no more effective than infliximab in this population, he said at the annual Digestive Disease Week.

Patients with steroid-refractory acute severe UC were randomized to cyclosporine (55 patients) or infliximab (56 patients). The researchers sought to determine whether treatment failure was less frequent with cyclosporine than with infliximab.

Adults were randomized if they were having a severe acute flare of UC (Lichtiger score greater than 10) and were refractory to intravenous steroid therapy (greater than or equal to 0.8 mg/kg per day of methylprednisone or equivalent) for at least 5 days. They had to be naive to the two treatment drugs and could not be under treatment with azathioprine/6-mercaptopurine unless therapy had been initiated fewer than 4 weeks before randomization.

The two groups were treated for up to 98 days, and the trial’s primary end point was treatment failure, defined as an absence of early clinical response, relapse after day 7, colectomy, absence of remission off steroids at the trial’s end, a severe adverse event, or death. Secondary end points included the Lichtiger score from day 0 to day 7, the percentage of patients showing clinical response at day 7, endoscopic response and colectomy at day 98, and the number of severe adverse events.

Approximately half the patients in both groups were female, with a median age of approximately 37 years, and had UC for at least 1 year. More than 90% of patients in both groups were naive to azathioprine. Lichtiger scores in both groups were 11 and over, and Mayo scores ranged from less than or equal to 0 to 12.

For the primary end point of treatment failure, 60% failed in the cyclosporine arm versus 54% in the infliximab arm, a nonsignificant difference.

The response rate at day 7 was 85.4% in the cyclosporine arm versus 85.7% in the infliximab arm, also not a significant difference. Response was defined as a Lichtiger score less than 10, and a decrease of at least 3 points compared with baseline.

The Lichtiger score from day 0 to day 6 showed that the median time to clinical response was 4 days (interquartile range [IQR], 3-6) with infliximab, versus 5 days (IQR, 4-7) for cyclosporine, a significant difference (P = .046).

At day 98, signs of mucosal healing were found in 52% of patients in the cyclosporine group and 53% of patients in the infliximab group. Healing was defined as having a Mayo endoscopic subscore of 0-1.

The colectomy rates were 18% in the cyclosporine arm and 21% in the infliximab arm. Severe adverse events affected 15% (8 patients) in the cyclosporine group and 25% (14 patients) in the infliximab group. Three patients developed cytomegalovirus colitis and two developed septicemia.

"In acute severe ulcerative colitis refractory to intravenous steroids, cyclosporine was not more effective than infliximab," said Dr. Laharie. "The short-term response was achieved with both drugs in more than 80% of patients within 1 week. Three-month colectomy rates were similar (18% with cyclosporine versus 21% with infliximab). And in this severe population, both drugs were well tolerated," he said.

Dr. Laharie disclosed financial relationships with Schering-Plough and Abbott Laboratories (royalty, speaking, and teaching), and with Norgine (consulting fee and board membership). The study received support from the Association François Aupetit, the Société Nationale Française de Gastro-Entérologie, and the International Organization for the Study of Inflammatory Bowel Disease, and was sponsored by Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif.

CHICAGO – A randomized, multicenter open-label trial found that cyclosporine was not more effective than infliximab in patients with acute, severe ulcerative colitis refractory to intravenous steroids, according to Dr. David Laharie.

Acute severe ulcerative colitis (UC) occurs in about 25% of patients with UC, and while intravenous corticosteroids are the primary therapy, 40% of patients are refractory to them. After steroid failure, only two medical options are available to avoid colectomy: cyclosporine and infliximab.

"However, there has been no randomized clinical trial comparing the two," said Dr. Laharie of Centre Hospitalier Universitaire in Bordeaux, France. He presented the findings of a multicenter, randomized open-label study comparing cyclosporine with infliximab in severe acute UC refractory to intravenous steroids. This study found cyclosporine to be no more effective than infliximab in this population, he said at the annual Digestive Disease Week.

Patients with steroid-refractory acute severe UC were randomized to cyclosporine (55 patients) or infliximab (56 patients). The researchers sought to determine whether treatment failure was less frequent with cyclosporine than with infliximab.

Adults were randomized if they were having a severe acute flare of UC (Lichtiger score greater than 10) and were refractory to intravenous steroid therapy (greater than or equal to 0.8 mg/kg per day of methylprednisone or equivalent) for at least 5 days. They had to be naive to the two treatment drugs and could not be under treatment with azathioprine/6-mercaptopurine unless therapy had been initiated fewer than 4 weeks before randomization.

The two groups were treated for up to 98 days, and the trial’s primary end point was treatment failure, defined as an absence of early clinical response, relapse after day 7, colectomy, absence of remission off steroids at the trial’s end, a severe adverse event, or death. Secondary end points included the Lichtiger score from day 0 to day 7, the percentage of patients showing clinical response at day 7, endoscopic response and colectomy at day 98, and the number of severe adverse events.

Approximately half the patients in both groups were female, with a median age of approximately 37 years, and had UC for at least 1 year. More than 90% of patients in both groups were naive to azathioprine. Lichtiger scores in both groups were 11 and over, and Mayo scores ranged from less than or equal to 0 to 12.

For the primary end point of treatment failure, 60% failed in the cyclosporine arm versus 54% in the infliximab arm, a nonsignificant difference.

The response rate at day 7 was 85.4% in the cyclosporine arm versus 85.7% in the infliximab arm, also not a significant difference. Response was defined as a Lichtiger score less than 10, and a decrease of at least 3 points compared with baseline.

The Lichtiger score from day 0 to day 6 showed that the median time to clinical response was 4 days (interquartile range [IQR], 3-6) with infliximab, versus 5 days (IQR, 4-7) for cyclosporine, a significant difference (P = .046).

At day 98, signs of mucosal healing were found in 52% of patients in the cyclosporine group and 53% of patients in the infliximab group. Healing was defined as having a Mayo endoscopic subscore of 0-1.

The colectomy rates were 18% in the cyclosporine arm and 21% in the infliximab arm. Severe adverse events affected 15% (8 patients) in the cyclosporine group and 25% (14 patients) in the infliximab group. Three patients developed cytomegalovirus colitis and two developed septicemia.

"In acute severe ulcerative colitis refractory to intravenous steroids, cyclosporine was not more effective than infliximab," said Dr. Laharie. "The short-term response was achieved with both drugs in more than 80% of patients within 1 week. Three-month colectomy rates were similar (18% with cyclosporine versus 21% with infliximab). And in this severe population, both drugs were well tolerated," he said.

Dr. Laharie disclosed financial relationships with Schering-Plough and Abbott Laboratories (royalty, speaking, and teaching), and with Norgine (consulting fee and board membership). The study received support from the Association François Aupetit, the Société Nationale Française de Gastro-Entérologie, and the International Organization for the Study of Inflammatory Bowel Disease, and was sponsored by Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif.

CHICAGO – A randomized, multicenter open-label trial found that cyclosporine was not more effective than infliximab in patients with acute, severe ulcerative colitis refractory to intravenous steroids, according to Dr. David Laharie.

Acute severe ulcerative colitis (UC) occurs in about 25% of patients with UC, and while intravenous corticosteroids are the primary therapy, 40% of patients are refractory to them. After steroid failure, only two medical options are available to avoid colectomy: cyclosporine and infliximab.

"However, there has been no randomized clinical trial comparing the two," said Dr. Laharie of Centre Hospitalier Universitaire in Bordeaux, France. He presented the findings of a multicenter, randomized open-label study comparing cyclosporine with infliximab in severe acute UC refractory to intravenous steroids. This study found cyclosporine to be no more effective than infliximab in this population, he said at the annual Digestive Disease Week.

Patients with steroid-refractory acute severe UC were randomized to cyclosporine (55 patients) or infliximab (56 patients). The researchers sought to determine whether treatment failure was less frequent with cyclosporine than with infliximab.

Adults were randomized if they were having a severe acute flare of UC (Lichtiger score greater than 10) and were refractory to intravenous steroid therapy (greater than or equal to 0.8 mg/kg per day of methylprednisone or equivalent) for at least 5 days. They had to be naive to the two treatment drugs and could not be under treatment with azathioprine/6-mercaptopurine unless therapy had been initiated fewer than 4 weeks before randomization.

The two groups were treated for up to 98 days, and the trial’s primary end point was treatment failure, defined as an absence of early clinical response, relapse after day 7, colectomy, absence of remission off steroids at the trial’s end, a severe adverse event, or death. Secondary end points included the Lichtiger score from day 0 to day 7, the percentage of patients showing clinical response at day 7, endoscopic response and colectomy at day 98, and the number of severe adverse events.

Approximately half the patients in both groups were female, with a median age of approximately 37 years, and had UC for at least 1 year. More than 90% of patients in both groups were naive to azathioprine. Lichtiger scores in both groups were 11 and over, and Mayo scores ranged from less than or equal to 0 to 12.

For the primary end point of treatment failure, 60% failed in the cyclosporine arm versus 54% in the infliximab arm, a nonsignificant difference.

The response rate at day 7 was 85.4% in the cyclosporine arm versus 85.7% in the infliximab arm, also not a significant difference. Response was defined as a Lichtiger score less than 10, and a decrease of at least 3 points compared with baseline.

The Lichtiger score from day 0 to day 6 showed that the median time to clinical response was 4 days (interquartile range [IQR], 3-6) with infliximab, versus 5 days (IQR, 4-7) for cyclosporine, a significant difference (P = .046).

At day 98, signs of mucosal healing were found in 52% of patients in the cyclosporine group and 53% of patients in the infliximab group. Healing was defined as having a Mayo endoscopic subscore of 0-1.

The colectomy rates were 18% in the cyclosporine arm and 21% in the infliximab arm. Severe adverse events affected 15% (8 patients) in the cyclosporine group and 25% (14 patients) in the infliximab group. Three patients developed cytomegalovirus colitis and two developed septicemia.

"In acute severe ulcerative colitis refractory to intravenous steroids, cyclosporine was not more effective than infliximab," said Dr. Laharie. "The short-term response was achieved with both drugs in more than 80% of patients within 1 week. Three-month colectomy rates were similar (18% with cyclosporine versus 21% with infliximab). And in this severe population, both drugs were well tolerated," he said.

Dr. Laharie disclosed financial relationships with Schering-Plough and Abbott Laboratories (royalty, speaking, and teaching), and with Norgine (consulting fee and board membership). The study received support from the Association François Aupetit, the Société Nationale Française de Gastro-Entérologie, and the International Organization for the Study of Inflammatory Bowel Disease, and was sponsored by Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Several modifiable technical factors can influence detection of colorectal adenomas, as can lifestyle factors, based on data from a large study conducted in the United Kingdom.

The findings came from the National Health Service (NHS) Bowel Cancer Screening Program, the largest study to examine the effects of patient and physician factors on adenoma detection during colonoscopy. The colonoscopies in this study were done to follow-up on positive fecal occult blood test (FOBT) results, said Dr. Tom J. Lee of Newcastle (U.K.) University, who presented the data at the annual Digestive Disease Week.

"Many factors affect the chance of an adenoma being detected," he said, "including patient factors, both modifiable and nonmodifiable, and colonoscopy factors, which are usually technical."

The NHS program offers a colonoscopy to any person aged 60-74 years who has a positive FOBT result. "It is a unique opportunity to study the interplay of factors that influence adenoma detection," Dr. Lee said.

From 2006 to 2009, fecal occult blood tests were returned by 2,269,983 persons (mean age 66 years; 60% male), and 2% of these were positive. The total number of colonoscopies (performed by 177 experienced endoscopists at 50 screening centers) was 36,460, of which 31,088 were included in this analysis. Of the patients who underwent colonoscopy, 14,423 (46%) had at least one adenoma.

Data were collected on cecal intubation, rectal retroversion, mean withdrawal time for the endoscopist, quality of bowel prep, use of the antispasmodic hyoscine butylbromide, start time of the procedure, and sedation use. Patient factors included gender, age, smoking and alcohol status, and geographic area.

Adverse lifestyle can negate protection for women

In the multivariate analysis, risk for adenomas was significantly associated with male gender, older age, current or previous smoking, and current alcohol use.

Men were more likely than women to have adenomas, and poor lifestyle habits elevated the risk further beyond that from gender alone. Among patients who did not drink or smoke, 45% of men had one or more adenomas, compared with 32% of women.

In men, this rate rose progressively according to alcohol and smoking status, exceeding 60% for men who reported current smoking and alcohol intake, Dr. Lee said. The same pattern held true for women; those reporting current alcohol intake and cigarette use had a 43% risk of having an adenoma.

All the associations were highly significant for the detection of any adenomas, advanced adenomas, and right-sided adenomas at a P value less than .001.

"Female smokers who drink had a significantly higher risk than men who did not smoke or drink. We found that adverse lifestyle factors can overcome gender protection from adenomas in females," Dr. Lee reported. "This stresses the importance of lifestyle factors in the development of adenomas."

In addition, older age was a significant factor, as was geographic area, even after adjustment for other factors. "There was a significant variation in risk depending on where the procedure was done," he said.

Technical factors linked to detection rate

The technical or procedural factors that were significantly associated with detection of adenomas were cecal intubation, longer withdrawal time, higher-quality bowel preparation, use of an intravenous antispasmodic, earlier procedure start time, and greater colonoscopist experience, Dr. Lee reported.

Similar results were found for the effect of these factors on detection of advanced adenomas and right-sided adenomas.

Procedures in which the cecum was reached had a threefold greater likelihood of detecting adenomas overall (P less than .001), and a more than fivefold greater likelihood in the right colon (P less than .001). A mean withdrawal time for the endoscopist greater than or equal to 10 minutes increased the detection rate by 10% overall and by 28% in the right colon (P less than .001). Bowel prep that was adequate or better was associated with an almost 40% increased chance for detection (P less than .001) and the use of hyoscine was associated with a 30% increase (P less than .001), although it is possible that hyoscine use is "an indicator of a good colonoscopist," Dr. Lee suggested.

The association with the time of day offers "fascinating insight into colonoscopists’ behavior," he added. As the day progressed from 8 a.m. to noon, there was no change in cecal intubation, bowel prep, or withdrawal times, but adenoma detection diminished from nearly 48% to 45%. Adenoma detection rates rose again until 3 p.m., then dropped back to around 45%, creating a "biphasic" pattern, he noted.

"Interestingly, procedures in which rectal retroversion was performed were not associated with increased detection of one or more adenomas and did not increase the detection of rectal adenomas," he added. There was also no association with sedation.

Dr. Lee acknowledged the study’s limitations: it was not a randomized controlled trial, certain risk factors (family history, NSAID use) were not accounted for, and the scoring tools were also not validated, especially for bowel prep quality.

"Our study probably raises more questions than it answers," he acknowledged. Further study of geographical variations, time of day variations, and nontechnical colonoscopy factors should be performed, he suggested. Meanwhile, at least one current recommendation can be emphasized: that colonoscope withdrawal time should be at least 10 minutes, he said.

Dr. Lee had no relevant financial disclosures.

CHICAGO – Several modifiable technical factors can influence detection of colorectal adenomas, as can lifestyle factors, based on data from a large study conducted in the United Kingdom.

The findings came from the National Health Service (NHS) Bowel Cancer Screening Program, the largest study to examine the effects of patient and physician factors on adenoma detection during colonoscopy. The colonoscopies in this study were done to follow-up on positive fecal occult blood test (FOBT) results, said Dr. Tom J. Lee of Newcastle (U.K.) University, who presented the data at the annual Digestive Disease Week.

"Many factors affect the chance of an adenoma being detected," he said, "including patient factors, both modifiable and nonmodifiable, and colonoscopy factors, which are usually technical."

The NHS program offers a colonoscopy to any person aged 60-74 years who has a positive FOBT result. "It is a unique opportunity to study the interplay of factors that influence adenoma detection," Dr. Lee said.

From 2006 to 2009, fecal occult blood tests were returned by 2,269,983 persons (mean age 66 years; 60% male), and 2% of these were positive. The total number of colonoscopies (performed by 177 experienced endoscopists at 50 screening centers) was 36,460, of which 31,088 were included in this analysis. Of the patients who underwent colonoscopy, 14,423 (46%) had at least one adenoma.

Data were collected on cecal intubation, rectal retroversion, mean withdrawal time for the endoscopist, quality of bowel prep, use of the antispasmodic hyoscine butylbromide, start time of the procedure, and sedation use. Patient factors included gender, age, smoking and alcohol status, and geographic area.

Adverse lifestyle can negate protection for women

In the multivariate analysis, risk for adenomas was significantly associated with male gender, older age, current or previous smoking, and current alcohol use.

Men were more likely than women to have adenomas, and poor lifestyle habits elevated the risk further beyond that from gender alone. Among patients who did not drink or smoke, 45% of men had one or more adenomas, compared with 32% of women.

In men, this rate rose progressively according to alcohol and smoking status, exceeding 60% for men who reported current smoking and alcohol intake, Dr. Lee said. The same pattern held true for women; those reporting current alcohol intake and cigarette use had a 43% risk of having an adenoma.

All the associations were highly significant for the detection of any adenomas, advanced adenomas, and right-sided adenomas at a P value less than .001.

"Female smokers who drink had a significantly higher risk than men who did not smoke or drink. We found that adverse lifestyle factors can overcome gender protection from adenomas in females," Dr. Lee reported. "This stresses the importance of lifestyle factors in the development of adenomas."

In addition, older age was a significant factor, as was geographic area, even after adjustment for other factors. "There was a significant variation in risk depending on where the procedure was done," he said.

Technical factors linked to detection rate

The technical or procedural factors that were significantly associated with detection of adenomas were cecal intubation, longer withdrawal time, higher-quality bowel preparation, use of an intravenous antispasmodic, earlier procedure start time, and greater colonoscopist experience, Dr. Lee reported.

Similar results were found for the effect of these factors on detection of advanced adenomas and right-sided adenomas.

Procedures in which the cecum was reached had a threefold greater likelihood of detecting adenomas overall (P less than .001), and a more than fivefold greater likelihood in the right colon (P less than .001). A mean withdrawal time for the endoscopist greater than or equal to 10 minutes increased the detection rate by 10% overall and by 28% in the right colon (P less than .001). Bowel prep that was adequate or better was associated with an almost 40% increased chance for detection (P less than .001) and the use of hyoscine was associated with a 30% increase (P less than .001), although it is possible that hyoscine use is "an indicator of a good colonoscopist," Dr. Lee suggested.

The association with the time of day offers "fascinating insight into colonoscopists’ behavior," he added. As the day progressed from 8 a.m. to noon, there was no change in cecal intubation, bowel prep, or withdrawal times, but adenoma detection diminished from nearly 48% to 45%. Adenoma detection rates rose again until 3 p.m., then dropped back to around 45%, creating a "biphasic" pattern, he noted.

"Interestingly, procedures in which rectal retroversion was performed were not associated with increased detection of one or more adenomas and did not increase the detection of rectal adenomas," he added. There was also no association with sedation.

Dr. Lee acknowledged the study’s limitations: it was not a randomized controlled trial, certain risk factors (family history, NSAID use) were not accounted for, and the scoring tools were also not validated, especially for bowel prep quality.

"Our study probably raises more questions than it answers," he acknowledged. Further study of geographical variations, time of day variations, and nontechnical colonoscopy factors should be performed, he suggested. Meanwhile, at least one current recommendation can be emphasized: that colonoscope withdrawal time should be at least 10 minutes, he said.

Dr. Lee had no relevant financial disclosures.

CHICAGO – Several modifiable technical factors can influence detection of colorectal adenomas, as can lifestyle factors, based on data from a large study conducted in the United Kingdom.

The findings came from the National Health Service (NHS) Bowel Cancer Screening Program, the largest study to examine the effects of patient and physician factors on adenoma detection during colonoscopy. The colonoscopies in this study were done to follow-up on positive fecal occult blood test (FOBT) results, said Dr. Tom J. Lee of Newcastle (U.K.) University, who presented the data at the annual Digestive Disease Week.

"Many factors affect the chance of an adenoma being detected," he said, "including patient factors, both modifiable and nonmodifiable, and colonoscopy factors, which are usually technical."

The NHS program offers a colonoscopy to any person aged 60-74 years who has a positive FOBT result. "It is a unique opportunity to study the interplay of factors that influence adenoma detection," Dr. Lee said.

From 2006 to 2009, fecal occult blood tests were returned by 2,269,983 persons (mean age 66 years; 60% male), and 2% of these were positive. The total number of colonoscopies (performed by 177 experienced endoscopists at 50 screening centers) was 36,460, of which 31,088 were included in this analysis. Of the patients who underwent colonoscopy, 14,423 (46%) had at least one adenoma.

Data were collected on cecal intubation, rectal retroversion, mean withdrawal time for the endoscopist, quality of bowel prep, use of the antispasmodic hyoscine butylbromide, start time of the procedure, and sedation use. Patient factors included gender, age, smoking and alcohol status, and geographic area.

Adverse lifestyle can negate protection for women

In the multivariate analysis, risk for adenomas was significantly associated with male gender, older age, current or previous smoking, and current alcohol use.

Men were more likely than women to have adenomas, and poor lifestyle habits elevated the risk further beyond that from gender alone. Among patients who did not drink or smoke, 45% of men had one or more adenomas, compared with 32% of women.

In men, this rate rose progressively according to alcohol and smoking status, exceeding 60% for men who reported current smoking and alcohol intake, Dr. Lee said. The same pattern held true for women; those reporting current alcohol intake and cigarette use had a 43% risk of having an adenoma.

All the associations were highly significant for the detection of any adenomas, advanced adenomas, and right-sided adenomas at a P value less than .001.

"Female smokers who drink had a significantly higher risk than men who did not smoke or drink. We found that adverse lifestyle factors can overcome gender protection from adenomas in females," Dr. Lee reported. "This stresses the importance of lifestyle factors in the development of adenomas."

In addition, older age was a significant factor, as was geographic area, even after adjustment for other factors. "There was a significant variation in risk depending on where the procedure was done," he said.

Technical factors linked to detection rate

The technical or procedural factors that were significantly associated with detection of adenomas were cecal intubation, longer withdrawal time, higher-quality bowel preparation, use of an intravenous antispasmodic, earlier procedure start time, and greater colonoscopist experience, Dr. Lee reported.

Similar results were found for the effect of these factors on detection of advanced adenomas and right-sided adenomas.

Procedures in which the cecum was reached had a threefold greater likelihood of detecting adenomas overall (P less than .001), and a more than fivefold greater likelihood in the right colon (P less than .001). A mean withdrawal time for the endoscopist greater than or equal to 10 minutes increased the detection rate by 10% overall and by 28% in the right colon (P less than .001). Bowel prep that was adequate or better was associated with an almost 40% increased chance for detection (P less than .001) and the use of hyoscine was associated with a 30% increase (P less than .001), although it is possible that hyoscine use is "an indicator of a good colonoscopist," Dr. Lee suggested.

The association with the time of day offers "fascinating insight into colonoscopists’ behavior," he added. As the day progressed from 8 a.m. to noon, there was no change in cecal intubation, bowel prep, or withdrawal times, but adenoma detection diminished from nearly 48% to 45%. Adenoma detection rates rose again until 3 p.m., then dropped back to around 45%, creating a "biphasic" pattern, he noted.

"Interestingly, procedures in which rectal retroversion was performed were not associated with increased detection of one or more adenomas and did not increase the detection of rectal adenomas," he added. There was also no association with sedation.

Dr. Lee acknowledged the study’s limitations: it was not a randomized controlled trial, certain risk factors (family history, NSAID use) were not accounted for, and the scoring tools were also not validated, especially for bowel prep quality.

"Our study probably raises more questions than it answers," he acknowledged. Further study of geographical variations, time of day variations, and nontechnical colonoscopy factors should be performed, he suggested. Meanwhile, at least one current recommendation can be emphasized: that colonoscope withdrawal time should be at least 10 minutes, he said.

Dr. Lee had no relevant financial disclosures.

CHICAGO – Several modifiable technical factors can influence detection of colorectal adenomas, as can lifestyle factors, based on data from a large study conducted in the United Kingdom.

The findings came from the National Health Service (NHS) Bowel Cancer Screening Program, the largest study to examine the effects of patient and physician factors on adenoma detection during colonoscopy. The colonoscopies in this study were done to follow-up on positive fecal occult blood test (FOBT) results, said Dr. Tom J. Lee of Newcastle (U.K.) University, who presented the data at the annual Digestive Disease Week.

"Many factors affect the chance of an adenoma being detected," he said, "including patient factors, both modifiable and nonmodifiable, and colonoscopy factors, which are usually technical."

The NHS program offers a colonoscopy to any person aged 60-74 years who has a positive FOBT result. "It is a unique opportunity to study the interplay of factors that influence adenoma detection," Dr. Lee said.

From 2006 to 2009, fecal occult blood tests were returned by 2,269,983 persons (mean age 66 years; 60% male), and 2% of these were positive. The total number of colonoscopies (performed by 177 experienced endoscopists at 50 screening centers) was 36,460, of which 31,088 were included in this analysis. Of the patients who underwent colonoscopy, 14,423 (46%) had at least one adenoma.

Data were collected on cecal intubation, rectal retroversion, mean withdrawal time for the endoscopist, quality of bowel prep, use of the antispasmodic hyoscine butylbromide, start time of the procedure, and sedation use. Patient factors included gender, age, smoking and alcohol status, and geographic area.

Adverse lifestyle can negate protection for women

In the multivariate analysis, risk for adenomas was significantly associated with male gender, older age, current or previous smoking, and current alcohol use.

Men were more likely than women to have adenomas, and poor lifestyle habits elevated the risk further beyond that from gender alone. Among patients who did not drink or smoke, 45% of men had one or more adenomas, compared with 32% of women.

In men, this rate rose progressively according to alcohol and smoking status, exceeding 60% for men who reported current smoking and alcohol intake, Dr. Lee said. The same pattern held true for women; those reporting current alcohol intake and cigarette use had a 43% risk of having an adenoma.

All the associations were highly significant for the detection of any adenomas, advanced adenomas, and right-sided adenomas at a P value less than .001.

"Female smokers who drink had a significantly higher risk than men who did not smoke or drink. We found that adverse lifestyle factors can overcome gender protection from adenomas in females," Dr. Lee reported. "This stresses the importance of lifestyle factors in the development of adenomas."

In addition, older age was a significant factor, as was geographic area, even after adjustment for other factors. "There was a significant variation in risk depending on where the procedure was done," he said.

Technical factors linked to detection rate

The technical or procedural factors that were significantly associated with detection of adenomas were cecal intubation, longer withdrawal time, higher-quality bowel preparation, use of an intravenous antispasmodic, earlier procedure start time, and greater colonoscopist experience, Dr. Lee reported.

Similar results were found for the effect of these factors on detection of advanced adenomas and right-sided adenomas.

Procedures in which the cecum was reached had a threefold greater likelihood of detecting adenomas overall (P less than .001), and a more than fivefold greater likelihood in the right colon (P less than .001). A mean withdrawal time for the endoscopist greater than or equal to 10 minutes increased the detection rate by 10% overall and by 28% in the right colon (P less than .001). Bowel prep that was adequate or better was associated with an almost 40% increased chance for detection (P less than .001) and the use of hyoscine was associated with a 30% increase (P less than .001), although it is possible that hyoscine use is "an indicator of a good colonoscopist," Dr. Lee suggested.

The association with the time of day offers "fascinating insight into colonoscopists’ behavior," he added. As the day progressed from 8 a.m. to noon, there was no change in cecal intubation, bowel prep, or withdrawal times, but adenoma detection diminished from nearly 48% to 45%. Adenoma detection rates rose again until 3 p.m., then dropped back to around 45%, creating a "biphasic" pattern, he noted.

"Interestingly, procedures in which rectal retroversion was performed were not associated with increased detection of one or more adenomas and did not increase the detection of rectal adenomas," he added. There was also no association with sedation.

Dr. Lee acknowledged the study’s limitations: it was not a randomized controlled trial, certain risk factors (family history, NSAID use) were not accounted for, and the scoring tools were also not validated, especially for bowel prep quality.

"Our study probably raises more questions than it answers," he acknowledged. Further study of geographical variations, time of day variations, and nontechnical colonoscopy factors should be performed, he suggested. Meanwhile, at least one current recommendation can be emphasized: that colonoscope withdrawal time should be at least 10 minutes, he said.

Dr. Lee had no relevant financial disclosures.

CHICAGO – Several modifiable technical factors can influence detection of colorectal adenomas, as can lifestyle factors, based on data from a large study conducted in the United Kingdom.

The findings came from the National Health Service (NHS) Bowel Cancer Screening Program, the largest study to examine the effects of patient and physician factors on adenoma detection during colonoscopy. The colonoscopies in this study were done to follow-up on positive fecal occult blood test (FOBT) results, said Dr. Tom J. Lee of Newcastle (U.K.) University, who presented the data at the annual Digestive Disease Week.

"Many factors affect the chance of an adenoma being detected," he said, "including patient factors, both modifiable and nonmodifiable, and colonoscopy factors, which are usually technical."

The NHS program offers a colonoscopy to any person aged 60-74 years who has a positive FOBT result. "It is a unique opportunity to study the interplay of factors that influence adenoma detection," Dr. Lee said.

From 2006 to 2009, fecal occult blood tests were returned by 2,269,983 persons (mean age 66 years; 60% male), and 2% of these were positive. The total number of colonoscopies (performed by 177 experienced endoscopists at 50 screening centers) was 36,460, of which 31,088 were included in this analysis. Of the patients who underwent colonoscopy, 14,423 (46%) had at least one adenoma.

Data were collected on cecal intubation, rectal retroversion, mean withdrawal time for the endoscopist, quality of bowel prep, use of the antispasmodic hyoscine butylbromide, start time of the procedure, and sedation use. Patient factors included gender, age, smoking and alcohol status, and geographic area.

Adverse lifestyle can negate protection for women

In the multivariate analysis, risk for adenomas was significantly associated with male gender, older age, current or previous smoking, and current alcohol use.

Men were more likely than women to have adenomas, and poor lifestyle habits elevated the risk further beyond that from gender alone. Among patients who did not drink or smoke, 45% of men had one or more adenomas, compared with 32% of women.

In men, this rate rose progressively according to alcohol and smoking status, exceeding 60% for men who reported current smoking and alcohol intake, Dr. Lee said. The same pattern held true for women; those reporting current alcohol intake and cigarette use had a 43% risk of having an adenoma.

All the associations were highly significant for the detection of any adenomas, advanced adenomas, and right-sided adenomas at a P value less than .001.

"Female smokers who drink had a significantly higher risk than men who did not smoke or drink. We found that adverse lifestyle factors can overcome gender protection from adenomas in females," Dr. Lee reported. "This stresses the importance of lifestyle factors in the development of adenomas."

In addition, older age was a significant factor, as was geographic area, even after adjustment for other factors. "There was a significant variation in risk depending on where the procedure was done," he said.

Technical factors linked to detection rate

The technical or procedural factors that were significantly associated with detection of adenomas were cecal intubation, longer withdrawal time, higher-quality bowel preparation, use of an intravenous antispasmodic, earlier procedure start time, and greater colonoscopist experience, Dr. Lee reported.

Similar results were found for the effect of these factors on detection of advanced adenomas and right-sided adenomas.

Procedures in which the cecum was reached had a threefold greater likelihood of detecting adenomas overall (P less than .001), and a more than fivefold greater likelihood in the right colon (P less than .001). A mean withdrawal time for the endoscopist greater than or equal to 10 minutes increased the detection rate by 10% overall and by 28% in the right colon (P less than .001). Bowel prep that was adequate or better was associated with an almost 40% increased chance for detection (P less than .001) and the use of hyoscine was associated with a 30% increase (P less than .001), although it is possible that hyoscine use is "an indicator of a good colonoscopist," Dr. Lee suggested.

The association with the time of day offers "fascinating insight into colonoscopists’ behavior," he added. As the day progressed from 8 a.m. to noon, there was no change in cecal intubation, bowel prep, or withdrawal times, but adenoma detection diminished from nearly 48% to 45%. Adenoma detection rates rose again until 3 p.m., then dropped back to around 45%, creating a "biphasic" pattern, he noted.

"Interestingly, procedures in which rectal retroversion was performed were not associated with increased detection of one or more adenomas and did not increase the detection of rectal adenomas," he added. There was also no association with sedation.

Dr. Lee acknowledged the study’s limitations: it was not a randomized controlled trial, certain risk factors (family history, NSAID use) were not accounted for, and the scoring tools were also not validated, especially for bowel prep quality.

"Our study probably raises more questions than it answers," he acknowledged. Further study of geographical variations, time of day variations, and nontechnical colonoscopy factors should be performed, he suggested. Meanwhile, at least one current recommendation can be emphasized: that colonoscope withdrawal time should be at least 10 minutes, he said.

Dr. Lee had no relevant financial disclosures.

CHICAGO – Several modifiable technical factors can influence detection of colorectal adenomas, as can lifestyle factors, based on data from a large study conducted in the United Kingdom.

The findings came from the National Health Service (NHS) Bowel Cancer Screening Program, the largest study to examine the effects of patient and physician factors on adenoma detection during colonoscopy. The colonoscopies in this study were done to follow-up on positive fecal occult blood test (FOBT) results, said Dr. Tom J. Lee of Newcastle (U.K.) University, who presented the data at the annual Digestive Disease Week.

"Many factors affect the chance of an adenoma being detected," he said, "including patient factors, both modifiable and nonmodifiable, and colonoscopy factors, which are usually technical."

The NHS program offers a colonoscopy to any person aged 60-74 years who has a positive FOBT result. "It is a unique opportunity to study the interplay of factors that influence adenoma detection," Dr. Lee said.

From 2006 to 2009, fecal occult blood tests were returned by 2,269,983 persons (mean age 66 years; 60% male), and 2% of these were positive. The total number of colonoscopies (performed by 177 experienced endoscopists at 50 screening centers) was 36,460, of which 31,088 were included in this analysis. Of the patients who underwent colonoscopy, 14,423 (46%) had at least one adenoma.

Data were collected on cecal intubation, rectal retroversion, mean withdrawal time for the endoscopist, quality of bowel prep, use of the antispasmodic hyoscine butylbromide, start time of the procedure, and sedation use. Patient factors included gender, age, smoking and alcohol status, and geographic area.

Adverse lifestyle can negate protection for women

In the multivariate analysis, risk for adenomas was significantly associated with male gender, older age, current or previous smoking, and current alcohol use.

Men were more likely than women to have adenomas, and poor lifestyle habits elevated the risk further beyond that from gender alone. Among patients who did not drink or smoke, 45% of men had one or more adenomas, compared with 32% of women.

In men, this rate rose progressively according to alcohol and smoking status, exceeding 60% for men who reported current smoking and alcohol intake, Dr. Lee said. The same pattern held true for women; those reporting current alcohol intake and cigarette use had a 43% risk of having an adenoma.

All the associations were highly significant for the detection of any adenomas, advanced adenomas, and right-sided adenomas at a P value less than .001.

"Female smokers who drink had a significantly higher risk than men who did not smoke or drink. We found that adverse lifestyle factors can overcome gender protection from adenomas in females," Dr. Lee reported. "This stresses the importance of lifestyle factors in the development of adenomas."

In addition, older age was a significant factor, as was geographic area, even after adjustment for other factors. "There was a significant variation in risk depending on where the procedure was done," he said.

Technical factors linked to detection rate

The technical or procedural factors that were significantly associated with detection of adenomas were cecal intubation, longer withdrawal time, higher-quality bowel preparation, use of an intravenous antispasmodic, earlier procedure start time, and greater colonoscopist experience, Dr. Lee reported.

Similar results were found for the effect of these factors on detection of advanced adenomas and right-sided adenomas.

Procedures in which the cecum was reached had a threefold greater likelihood of detecting adenomas overall (P less than .001), and a more than fivefold greater likelihood in the right colon (P less than .001). A mean withdrawal time for the endoscopist greater than or equal to 10 minutes increased the detection rate by 10% overall and by 28% in the right colon (P less than .001). Bowel prep that was adequate or better was associated with an almost 40% increased chance for detection (P less than .001) and the use of hyoscine was associated with a 30% increase (P less than .001), although it is possible that hyoscine use is "an indicator of a good colonoscopist," Dr. Lee suggested.

The association with the time of day offers "fascinating insight into colonoscopists’ behavior," he added. As the day progressed from 8 a.m. to noon, there was no change in cecal intubation, bowel prep, or withdrawal times, but adenoma detection diminished from nearly 48% to 45%. Adenoma detection rates rose again until 3 p.m., then dropped back to around 45%, creating a "biphasic" pattern, he noted.

"Interestingly, procedures in which rectal retroversion was performed were not associated with increased detection of one or more adenomas and did not increase the detection of rectal adenomas," he added. There was also no association with sedation.

Dr. Lee acknowledged the study’s limitations: it was not a randomized controlled trial, certain risk factors (family history, NSAID use) were not accounted for, and the scoring tools were also not validated, especially for bowel prep quality.

"Our study probably raises more questions than it answers," he acknowledged. Further study of geographical variations, time of day variations, and nontechnical colonoscopy factors should be performed, he suggested. Meanwhile, at least one current recommendation can be emphasized: that colonoscope withdrawal time should be at least 10 minutes, he said.

Dr. Lee had no relevant financial disclosures.

CHICAGO – Regular use of proton pump inhibitors is associated with an elevated risk of hip fractures, even after adjusting for important lifestyle risk factors, according to the findings of a prospective evaluation from the Nurses’ Health Study.

The association was most striking for women with a history of smoking, observed Dr. Hamed Khalili of Massachusetts General Hospital, Boston.

The Food and Drug Association recently issued an advisory regarding a potential link between PPIs and fractures. While acid-suppressing medications have been hypothesized to increase the risk of osteoporotic fractures, studies examining this association have been inconsistent. These analyses have mostly been based on retrospective studies of small populations that have not controlled for important dietary and lifestyle confounders, and they have ascertained PPI use only at a single time point, Dr. Khalili said.

The current study aimed to be more definitive by prospectively examining the relationship between chronic PPI use and incident hip fracture among 79,899 postmenopausal women enrolled in the Nurses’ Health Study, he said.

"We found that longer duration of use was associated with increased risk, and the strongest risk was confined to individuals with a history of smoking. ... Our findings support the recent decision of the FDA to revise labeling of PPIs to incorporate concerns about a possible increase in the risk of fractures," he said at the annual Digestive Disease Week.

In 1982, participants in the Nurses’ Health Study were first asked to report all previous fractures and were queried biennially for new fractures. Among the nearly 80,000 subjects, with 565,786 person-years of follow-up, there were 893 incident hip fractures over 8 years. PPI use was reported by 7% of participants in 2000 and by 19% of participants in 2008.

Regular use of PPIs posed fracture risks of 35%-45% when adjusted for age, calcium intake, and body mass index. The fully adjusted hazard ratio was 1.37, Dr. Khalili reported.

Current smoking status stood out as a significant effect modifier. Women who were current or past smokers and who regularly took a PPI had a 51% increased risk for fracture. In contrast, women who never smoked had only a 6% increased risk, "almost equal to women who never used PPIs," he noted.

Longer duration of use was associated with greater risk. Compared with never-users, risk in the multivariate analysis was 36% after 2 years of use, 42% after 4 years and 54% when PPIs were used for 6 years or longer (P less than 0.001), he said.

The investigators adjusted for multiple other risk factors, including physical activity; alcohol intake; total daily calcium and vitamin D intake; history of osteoporosis; and use of hormone replacement therapy, bisphosphonates, and thiazides. "This did not materially alter this association," he noted.

When PPIs were discontinued, the risks declined. Two or more years after discontinuation, the risk of hip fracture was just 9%-10%, he noted.

"The strengths of our study are that it offers detailed, prospectively collected and validated information on PPI use and other risk factors. We had a high response rate, and the participants are educated health professionals," he said. "But the study lacks information about PPI use prior to 2000, and it lacks specific information about brand and dose of PPI. It’s not clear whether this is generalizable to other populations."

The study, however, is in line with other reports of an association, and adds weight to the recommendation that clinicians carefully monitor the need for postmenopausal women to continue long-term on PPIs, especially those who smoke.

Response from the audience was robust, with one attendee noting, "This is truly excellent work," and another calling the study "impressive."

Dr. Khalili reported having no conflicts of interest.

CHICAGO – Regular use of proton pump inhibitors is associated with an elevated risk of hip fractures, even after adjusting for important lifestyle risk factors, according to the findings of a prospective evaluation from the Nurses’ Health Study.

The association was most striking for women with a history of smoking, observed Dr. Hamed Khalili of Massachusetts General Hospital, Boston.

The Food and Drug Association recently issued an advisory regarding a potential link between PPIs and fractures. While acid-suppressing medications have been hypothesized to increase the risk of osteoporotic fractures, studies examining this association have been inconsistent. These analyses have mostly been based on retrospective studies of small populations that have not controlled for important dietary and lifestyle confounders, and they have ascertained PPI use only at a single time point, Dr. Khalili said.

The current study aimed to be more definitive by prospectively examining the relationship between chronic PPI use and incident hip fracture among 79,899 postmenopausal women enrolled in the Nurses’ Health Study, he said.

"We found that longer duration of use was associated with increased risk, and the strongest risk was confined to individuals with a history of smoking. ... Our findings support the recent decision of the FDA to revise labeling of PPIs to incorporate concerns about a possible increase in the risk of fractures," he said at the annual Digestive Disease Week.

In 1982, participants in the Nurses’ Health Study were first asked to report all previous fractures and were queried biennially for new fractures. Among the nearly 80,000 subjects, with 565,786 person-years of follow-up, there were 893 incident hip fractures over 8 years. PPI use was reported by 7% of participants in 2000 and by 19% of participants in 2008.

Regular use of PPIs posed fracture risks of 35%-45% when adjusted for age, calcium intake, and body mass index. The fully adjusted hazard ratio was 1.37, Dr. Khalili reported.

Current smoking status stood out as a significant effect modifier. Women who were current or past smokers and who regularly took a PPI had a 51% increased risk for fracture. In contrast, women who never smoked had only a 6% increased risk, "almost equal to women who never used PPIs," he noted.

Longer duration of use was associated with greater risk. Compared with never-users, risk in the multivariate analysis was 36% after 2 years of use, 42% after 4 years and 54% when PPIs were used for 6 years or longer (P less than 0.001), he said.

The investigators adjusted for multiple other risk factors, including physical activity; alcohol intake; total daily calcium and vitamin D intake; history of osteoporosis; and use of hormone replacement therapy, bisphosphonates, and thiazides. "This did not materially alter this association," he noted.

When PPIs were discontinued, the risks declined. Two or more years after discontinuation, the risk of hip fracture was just 9%-10%, he noted.

"The strengths of our study are that it offers detailed, prospectively collected and validated information on PPI use and other risk factors. We had a high response rate, and the participants are educated health professionals," he said. "But the study lacks information about PPI use prior to 2000, and it lacks specific information about brand and dose of PPI. It’s not clear whether this is generalizable to other populations."

The study, however, is in line with other reports of an association, and adds weight to the recommendation that clinicians carefully monitor the need for postmenopausal women to continue long-term on PPIs, especially those who smoke.

Response from the audience was robust, with one attendee noting, "This is truly excellent work," and another calling the study "impressive."

Dr. Khalili reported having no conflicts of interest.

CHICAGO – Regular use of proton pump inhibitors is associated with an elevated risk of hip fractures, even after adjusting for important lifestyle risk factors, according to the findings of a prospective evaluation from the Nurses’ Health Study.

The association was most striking for women with a history of smoking, observed Dr. Hamed Khalili of Massachusetts General Hospital, Boston.

The Food and Drug Association recently issued an advisory regarding a potential link between PPIs and fractures. While acid-suppressing medications have been hypothesized to increase the risk of osteoporotic fractures, studies examining this association have been inconsistent. These analyses have mostly been based on retrospective studies of small populations that have not controlled for important dietary and lifestyle confounders, and they have ascertained PPI use only at a single time point, Dr. Khalili said.

The current study aimed to be more definitive by prospectively examining the relationship between chronic PPI use and incident hip fracture among 79,899 postmenopausal women enrolled in the Nurses’ Health Study, he said.

"We found that longer duration of use was associated with increased risk, and the strongest risk was confined to individuals with a history of smoking. ... Our findings support the recent decision of the FDA to revise labeling of PPIs to incorporate concerns about a possible increase in the risk of fractures," he said at the annual Digestive Disease Week.

In 1982, participants in the Nurses’ Health Study were first asked to report all previous fractures and were queried biennially for new fractures. Among the nearly 80,000 subjects, with 565,786 person-years of follow-up, there were 893 incident hip fractures over 8 years. PPI use was reported by 7% of participants in 2000 and by 19% of participants in 2008.

Regular use of PPIs posed fracture risks of 35%-45% when adjusted for age, calcium intake, and body mass index. The fully adjusted hazard ratio was 1.37, Dr. Khalili reported.

Current smoking status stood out as a significant effect modifier. Women who were current or past smokers and who regularly took a PPI had a 51% increased risk for fracture. In contrast, women who never smoked had only a 6% increased risk, "almost equal to women who never used PPIs," he noted.

Longer duration of use was associated with greater risk. Compared with never-users, risk in the multivariate analysis was 36% after 2 years of use, 42% after 4 years and 54% when PPIs were used for 6 years or longer (P less than 0.001), he said.

The investigators adjusted for multiple other risk factors, including physical activity; alcohol intake; total daily calcium and vitamin D intake; history of osteoporosis; and use of hormone replacement therapy, bisphosphonates, and thiazides. "This did not materially alter this association," he noted.

When PPIs were discontinued, the risks declined. Two or more years after discontinuation, the risk of hip fracture was just 9%-10%, he noted.

"The strengths of our study are that it offers detailed, prospectively collected and validated information on PPI use and other risk factors. We had a high response rate, and the participants are educated health professionals," he said. "But the study lacks information about PPI use prior to 2000, and it lacks specific information about brand and dose of PPI. It’s not clear whether this is generalizable to other populations."

The study, however, is in line with other reports of an association, and adds weight to the recommendation that clinicians carefully monitor the need for postmenopausal women to continue long-term on PPIs, especially those who smoke.

Response from the audience was robust, with one attendee noting, "This is truly excellent work," and another calling the study "impressive."

Dr. Khalili reported having no conflicts of interest.

CHICAGO – Regular use of proton pump inhibitors is associated with an elevated risk of hip fractures, even after adjusting for important lifestyle risk factors, according to the findings of a prospective evaluation from the Nurses’ Health Study.

The association was most striking for women with a history of smoking, observed Dr. Hamed Khalili of Massachusetts General Hospital, Boston.

The Food and Drug Association recently issued an advisory regarding a potential link between PPIs and fractures. While acid-suppressing medications have been hypothesized to increase the risk of osteoporotic fractures, studies examining this association have been inconsistent. These analyses have mostly been based on retrospective studies of small populations that have not controlled for important dietary and lifestyle confounders, and they have ascertained PPI use only at a single time point, Dr. Khalili said.

The current study aimed to be more definitive by prospectively examining the relationship between chronic PPI use and incident hip fracture among 79,899 postmenopausal women enrolled in the Nurses’ Health Study, he said.

"We found that longer duration of use was associated with increased risk, and the strongest risk was confined to individuals with a history of smoking. ... Our findings support the recent decision of the FDA to revise labeling of PPIs to incorporate concerns about a possible increase in the risk of fractures," he said at the annual Digestive Disease Week.

In 1982, participants in the Nurses’ Health Study were first asked to report all previous fractures and were queried biennially for new fractures. Among the nearly 80,000 subjects, with 565,786 person-years of follow-up, there were 893 incident hip fractures over 8 years. PPI use was reported by 7% of participants in 2000 and by 19% of participants in 2008.

Regular use of PPIs posed fracture risks of 35%-45% when adjusted for age, calcium intake, and body mass index. The fully adjusted hazard ratio was 1.37, Dr. Khalili reported.

Current smoking status stood out as a significant effect modifier. Women who were current or past smokers and who regularly took a PPI had a 51% increased risk for fracture. In contrast, women who never smoked had only a 6% increased risk, "almost equal to women who never used PPIs," he noted.

Longer duration of use was associated with greater risk. Compared with never-users, risk in the multivariate analysis was 36% after 2 years of use, 42% after 4 years and 54% when PPIs were used for 6 years or longer (P less than 0.001), he said.

The investigators adjusted for multiple other risk factors, including physical activity; alcohol intake; total daily calcium and vitamin D intake; history of osteoporosis; and use of hormone replacement therapy, bisphosphonates, and thiazides. "This did not materially alter this association," he noted.

When PPIs were discontinued, the risks declined. Two or more years after discontinuation, the risk of hip fracture was just 9%-10%, he noted.

"The strengths of our study are that it offers detailed, prospectively collected and validated information on PPI use and other risk factors. We had a high response rate, and the participants are educated health professionals," he said. "But the study lacks information about PPI use prior to 2000, and it lacks specific information about brand and dose of PPI. It’s not clear whether this is generalizable to other populations."

The study, however, is in line with other reports of an association, and adds weight to the recommendation that clinicians carefully monitor the need for postmenopausal women to continue long-term on PPIs, especially those who smoke.

Response from the audience was robust, with one attendee noting, "This is truly excellent work," and another calling the study "impressive."

Dr. Khalili reported having no conflicts of interest.

CHICAGO – Regular use of proton pump inhibitors is associated with an elevated risk of hip fractures, even after adjusting for important lifestyle risk factors, according to the findings of a prospective evaluation from the Nurses’ Health Study.

The association was most striking for women with a history of smoking, observed Dr. Hamed Khalili of Massachusetts General Hospital, Boston.

The Food and Drug Association recently issued an advisory regarding a potential link between PPIs and fractures. While acid-suppressing medications have been hypothesized to increase the risk of osteoporotic fractures, studies examining this association have been inconsistent. These analyses have mostly been based on retrospective studies of small populations that have not controlled for important dietary and lifestyle confounders, and they have ascertained PPI use only at a single time point, Dr. Khalili said.

The current study aimed to be more definitive by prospectively examining the relationship between chronic PPI use and incident hip fracture among 79,899 postmenopausal women enrolled in the Nurses’ Health Study, he said.

"We found that longer duration of use was associated with increased risk, and the strongest risk was confined to individuals with a history of smoking. ... Our findings support the recent decision of the FDA to revise labeling of PPIs to incorporate concerns about a possible increase in the risk of fractures," he said at the annual Digestive Disease Week.

In 1982, participants in the Nurses’ Health Study were first asked to report all previous fractures and were queried biennially for new fractures. Among the nearly 80,000 subjects, with 565,786 person-years of follow-up, there were 893 incident hip fractures over 8 years. PPI use was reported by 7% of participants in 2000 and by 19% of participants in 2008.

Regular use of PPIs posed fracture risks of 35%-45% when adjusted for age, calcium intake, and body mass index. The fully adjusted hazard ratio was 1.37, Dr. Khalili reported.

Current smoking status stood out as a significant effect modifier. Women who were current or past smokers and who regularly took a PPI had a 51% increased risk for fracture. In contrast, women who never smoked had only a 6% increased risk, "almost equal to women who never used PPIs," he noted.

Longer duration of use was associated with greater risk. Compared with never-users, risk in the multivariate analysis was 36% after 2 years of use, 42% after 4 years and 54% when PPIs were used for 6 years or longer (P less than 0.001), he said.

The investigators adjusted for multiple other risk factors, including physical activity; alcohol intake; total daily calcium and vitamin D intake; history of osteoporosis; and use of hormone replacement therapy, bisphosphonates, and thiazides. "This did not materially alter this association," he noted.

When PPIs were discontinued, the risks declined. Two or more years after discontinuation, the risk of hip fracture was just 9%-10%, he noted.

"The strengths of our study are that it offers detailed, prospectively collected and validated information on PPI use and other risk factors. We had a high response rate, and the participants are educated health professionals," he said. "But the study lacks information about PPI use prior to 2000, and it lacks specific information about brand and dose of PPI. It’s not clear whether this is generalizable to other populations."

The study, however, is in line with other reports of an association, and adds weight to the recommendation that clinicians carefully monitor the need for postmenopausal women to continue long-term on PPIs, especially those who smoke.

Response from the audience was robust, with one attendee noting, "This is truly excellent work," and another calling the study "impressive."

Dr. Khalili reported having no conflicts of interest.

CHICAGO – Regular use of proton pump inhibitors is associated with an elevated risk of hip fractures, even after adjusting for important lifestyle risk factors, according to the findings of a prospective evaluation from the Nurses’ Health Study.

The association was most striking for women with a history of smoking, observed Dr. Hamed Khalili of Massachusetts General Hospital, Boston.

The Food and Drug Association recently issued an advisory regarding a potential link between PPIs and fractures. While acid-suppressing medications have been hypothesized to increase the risk of osteoporotic fractures, studies examining this association have been inconsistent. These analyses have mostly been based on retrospective studies of small populations that have not controlled for important dietary and lifestyle confounders, and they have ascertained PPI use only at a single time point, Dr. Khalili said.

The current study aimed to be more definitive by prospectively examining the relationship between chronic PPI use and incident hip fracture among 79,899 postmenopausal women enrolled in the Nurses’ Health Study, he said.

"We found that longer duration of use was associated with increased risk, and the strongest risk was confined to individuals with a history of smoking. ... Our findings support the recent decision of the FDA to revise labeling of PPIs to incorporate concerns about a possible increase in the risk of fractures," he said at the annual Digestive Disease Week.

In 1982, participants in the Nurses’ Health Study were first asked to report all previous fractures and were queried biennially for new fractures. Among the nearly 80,000 subjects, with 565,786 person-years of follow-up, there were 893 incident hip fractures over 8 years. PPI use was reported by 7% of participants in 2000 and by 19% of participants in 2008.

Regular use of PPIs posed fracture risks of 35%-45% when adjusted for age, calcium intake, and body mass index. The fully adjusted hazard ratio was 1.37, Dr. Khalili reported.

Current smoking status stood out as a significant effect modifier. Women who were current or past smokers and who regularly took a PPI had a 51% increased risk for fracture. In contrast, women who never smoked had only a 6% increased risk, "almost equal to women who never used PPIs," he noted.

Longer duration of use was associated with greater risk. Compared with never-users, risk in the multivariate analysis was 36% after 2 years of use, 42% after 4 years and 54% when PPIs were used for 6 years or longer (P less than 0.001), he said.

The investigators adjusted for multiple other risk factors, including physical activity; alcohol intake; total daily calcium and vitamin D intake; history of osteoporosis; and use of hormone replacement therapy, bisphosphonates, and thiazides. "This did not materially alter this association," he noted.

When PPIs were discontinued, the risks declined. Two or more years after discontinuation, the risk of hip fracture was just 9%-10%, he noted.

"The strengths of our study are that it offers detailed, prospectively collected and validated information on PPI use and other risk factors. We had a high response rate, and the participants are educated health professionals," he said. "But the study lacks information about PPI use prior to 2000, and it lacks specific information about brand and dose of PPI. It’s not clear whether this is generalizable to other populations."

The study, however, is in line with other reports of an association, and adds weight to the recommendation that clinicians carefully monitor the need for postmenopausal women to continue long-term on PPIs, especially those who smoke.

Response from the audience was robust, with one attendee noting, "This is truly excellent work," and another calling the study "impressive."

Dr. Khalili reported having no conflicts of interest.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.