Meeting ID
3042-11
Series ID
2011

Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C

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Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C

CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

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CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

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Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C
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telaprevir, hepatitis C, virologic response rates, IL28B genotypes, phase III, ADVANCE trial, SVR, CT, TT, CC, allele, Incivek, Dr. Ira M. Jacobson, Digestive Disease Week, pegylated interferon, ribavirin
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telaprevir, hepatitis C, virologic response rates, IL28B genotypes, phase III, ADVANCE trial, SVR, CT, TT, CC, allele, Incivek, Dr. Ira M. Jacobson, Digestive Disease Week, pegylated interferon, ribavirin
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FROM THE ANNUAL DIGESTIVE DISEASE WEEK

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Inside the Article

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Major Finding: Sustained virologic response rates in patients with the CT allele for IL28B were 71% with 12-week telaprevir plus pegylated interferon and ribavirin (PR), 57% with 8-week telaprevir plus PR, and 25% with PR alone, and in patients with the TT allele, rates were 73%, 59% and 23%, respectively.

Data Source: Unplanned post hoc genotype analysis of 454 patients in the phase III ADVANCE trial.

Disclosures: Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, co-developers of telaprevir. Several co-authors also disclosed financial relationships including employment with Vertex.

Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C

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Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C

CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

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CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

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Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C
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telaprevir, hepatitis C, virologic response rates, IL28B genotypes, phase III, ADVANCE trial, SVR, CT, TT, CC, allele, Incivek, Dr. Ira M. Jacobson, Digestive Disease Week, pegylated interferon, ribavirin
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telaprevir, hepatitis C, virologic response rates, IL28B genotypes, phase III, ADVANCE trial, SVR, CT, TT, CC, allele, Incivek, Dr. Ira M. Jacobson, Digestive Disease Week, pegylated interferon, ribavirin
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Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C

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Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C

CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

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CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

CHICAGO – The addition of telaprevir to standard hepatitis C treatment substantially improved sustained virologic response rates across all IL28B genotypes in an unplanned post hoc analysis of the phase III ADVANCE trial.

The sustained virologic response (SVR) rate doubled and even tripled in patients with the CT or TT allele, and those with the CC allele also experienced an increase in SVR when telaprevir (Incivek) was included in the regimen, lead investigator Dr. Ira M. Jacobson reported in a late-breaking abstract session at the annual Digestive Disease Week.

Dr. Ira Jacobson    

Single nucleotide polymorphisms in the region of the IL28B gene have been strongly associated with response to standard treatment with pegylated interferon and ribavirin in patients infected with genotype 1 hepatitis C virus (HCV).

The current findings will change the physician dialogue with patients disheartened by early IL28B findings indicating that patients with the CC allele achieved much better responses than those with the CT or TT alleles, session cochair Dr. Andrew J. Muir said in an interview.

"From a clinical standpoint, some of my patients who did not know if they were CC or TT were very concerned," he said. "This changes that discussion a lot. All those patients can see they all get a benefit from this treatment. The CC [patients] still do better, but the fact that the TT and CT do very well is what the important message is for those patients."

The other benefit is that a shorter course of hepatitis C treatment might be possible for patients with the CC allele, said Dr. Muir, clinical director of hepatology at Duke University, Durham, N.C.

At press time, U.S. Food and Drug Administration approval of the protease inhibitors telaprevir and boceprevir was considered imminent, after the two drugs garnered unanimous support in late April from an FDA advisory committee. Pivotal data from the ADVANCE trial in patients with untreated HCV infection showed SVR rates of 75% for patients on a 12-week regimen of telaprevir plus standard treatment with pegylated interferon and ribavirin (PR) followed by 12 or 36 weeks of PR alone; 69% for those on 8 weeks of telaprevir plus PR followed by 4 weeks of placebo plus PR, followed by 12 or 36 weeks of PR alone; and just 44% for those on PR for 48 weeks (with placebo for telaprevir during the first 12 weeks).

The dosages used were: telaprevir, 750 mg every 8 hours; peginterferon alfa-2a, 180 mcg/week; and ribavirin, 1,000 or 1,200 mg/day.

The researchers conducted the genotype analysis during evaluation of an exploratory diagnostic assay that characterizes genetic polymorphisms near the IL28B gene. Using leftover, deidentified samples, test results were available for 454 (42%) of the 1,088 HCV genotype 1 patients at ADVANCE sites in the United States. Only white patients were genotyped for IL28B because of the small number of patients of other races.

The allele distribution was consistent with previous reports about treatment-naive patients, with 49% of patients having the CT allele, 33% the CC allele, and 18% the TT allele, said Dr. Jacobson, chief of the division of gastroenterology and hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York.

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.

The largest improvements in response, however, were observed in patients with the CT and TT alleles – the addition of telaprevir doubled and even tripled SVR rates, Dr. Jacobson said. SVR rates in the CT group reached 71% with 12-week telaprevir plus PR, 57% with 8-week telaprevir plus PR, and 25% with PR alone. SVR rates in the TT group were 73%, 59% and 23%, respectively.

"The impact of 12- and 8-week telaprevir appear to be greater in patients with a T allele than with a CC allele," he said.

Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR vs. 71% with 8-week telaprevir plus PR and 16% for PR alone. Corresponding data for the CT allele were 60%, 62%, and 2%, and for the TT allele were 59%, 50%, and 0%.

Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%, CT at 92%, and TT at 80%, Dr. Jacobson said. Patients with the CT and TT alleles who did not achieve eRVR had lower SVR rates than CC patients.

 

 

Further research, including studies on nonwhites, is needed to confirm these findings, Dr. Jacobson said.

Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, which are developing telaprevir together. Several coauthors also disclosed financial relationships including employment with Vertex.

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Telaprevir Ups Response Rates Across IL28B Genotypes in Hepatitis C
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telaprevir, hepatitis C, virologic response rates, IL28B genotypes, phase III, ADVANCE trial, SVR, CT, TT, CC, allele, Incivek, Dr. Ira M. Jacobson, Digestive Disease Week, pegylated interferon, ribavirin
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telaprevir, hepatitis C, virologic response rates, IL28B genotypes, phase III, ADVANCE trial, SVR, CT, TT, CC, allele, Incivek, Dr. Ira M. Jacobson, Digestive Disease Week, pegylated interferon, ribavirin
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Major Finding: Sustained virologic response rates in patients with the CT allele for IL28B were 71% with 12-week telaprevir plus pegylated interferon and ribavirin (PR), 57% with 8-week telaprevir plus PR, and 25% with PR alone, and in patients with the TT allele, rates were 73%, 59% and 23%, respectively.

Data Source: Unplanned post hoc genotype analysis of 454 patients in the phase III ADVANCE trial.

Disclosures: Dr. Jacobson disclosed numerous financial relationships with industry including grant support and other financial benefits from Tibotec and Vertex Pharmaceuticals, co-developers of telaprevir. Several co-authors also disclosed financial relationships including employment with Vertex.

Study: Mortality After Bariatric Surgery Not Higher for Elderly

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CHICAGO - Older patients undergoing bariatric surgery had longer hospital stays, but no increased risk of death or major adverse events at 30 days, according to a study of more than 48,000 adults. The findings were presented at the annual Digestive Disease Week on May 9.

Patient age older than 65 years is not a contraindication to bariatric surgery, said Dr. Robert B. Dorman in a press conference in advance of the meeting. Previous studies of bariatric surgery in older adults have been limited to Medicare patients and have not included laparoscopic procedures, he noted.

In this multihospital study, Dr. Dorman of the University of Minnesota, Minneapolis, and his colleagues analyzed data from 48,378 adults with a body mass index of 35 kg/m2 or higher who underwent bariatric surgery between 2005 and 2009. The patients were part of the American College of Surgeons National Surgical Quality Improvement Program.

The types of surgery included open and laparoscopic Roux-en-Y gastric bypass, open duodenal switch, laparoscopic adjustable gastric banding, and vertical banded gastroplasty.

The percentage of bariatric surgery patients aged 65 years or older increased from 1.9% in 2005 to 4.8% in 2009, a significant change. Among all patients, a total of 72 deaths occurred during the study period, and 8 of these occurred in patients aged 65 years or older.

The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges. Specifically, for patients aged 35-49 years, 50-64 years, and 65 years and older mortality was 0.12%, 0.21%, and 0.40%, respectively. A multivariate analysis showed a trend for advancing age as a predictor of mortality, but this was not statistically significant, the researchers noted.

However, age of 65 years or older was a significant predictor of prolonged length of stay for both open and laparoscopic procedures. In addition, older age alone was not a significant predictor of major adverse events for either procedure type. The significant predictors of major adverse events included BMI of 55 or higher, cardiac comorbidities, severe ASA [American Society of Anesthesiologists] score, albumin levels less than 3 g/dL, and creatinine levels greater than 1.5 mg/dL.

“Once corroborated, these results [will] provide important information to patients, surgeons, hospitals, and payers prior to performing bariatric surgery in older persons with obesity,” Dr. Dorman said.

However, “we are certainly not giving the green light for bariatric surgeons to operate on these patients without determining their risk on an individual basis,” he added.

Dr. Dorman had no financial conflicts to disclos

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CHICAGO - Older patients undergoing bariatric surgery had longer hospital stays, but no increased risk of death or major adverse events at 30 days, according to a study of more than 48,000 adults. The findings were presented at the annual Digestive Disease Week on May 9.

Patient age older than 65 years is not a contraindication to bariatric surgery, said Dr. Robert B. Dorman in a press conference in advance of the meeting. Previous studies of bariatric surgery in older adults have been limited to Medicare patients and have not included laparoscopic procedures, he noted.

In this multihospital study, Dr. Dorman of the University of Minnesota, Minneapolis, and his colleagues analyzed data from 48,378 adults with a body mass index of 35 kg/m2 or higher who underwent bariatric surgery between 2005 and 2009. The patients were part of the American College of Surgeons National Surgical Quality Improvement Program.

The types of surgery included open and laparoscopic Roux-en-Y gastric bypass, open duodenal switch, laparoscopic adjustable gastric banding, and vertical banded gastroplasty.

The percentage of bariatric surgery patients aged 65 years or older increased from 1.9% in 2005 to 4.8% in 2009, a significant change. Among all patients, a total of 72 deaths occurred during the study period, and 8 of these occurred in patients aged 65 years or older.

The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges. Specifically, for patients aged 35-49 years, 50-64 years, and 65 years and older mortality was 0.12%, 0.21%, and 0.40%, respectively. A multivariate analysis showed a trend for advancing age as a predictor of mortality, but this was not statistically significant, the researchers noted.

However, age of 65 years or older was a significant predictor of prolonged length of stay for both open and laparoscopic procedures. In addition, older age alone was not a significant predictor of major adverse events for either procedure type. The significant predictors of major adverse events included BMI of 55 or higher, cardiac comorbidities, severe ASA [American Society of Anesthesiologists] score, albumin levels less than 3 g/dL, and creatinine levels greater than 1.5 mg/dL.

“Once corroborated, these results [will] provide important information to patients, surgeons, hospitals, and payers prior to performing bariatric surgery in older persons with obesity,” Dr. Dorman said.

However, “we are certainly not giving the green light for bariatric surgeons to operate on these patients without determining their risk on an individual basis,” he added.

Dr. Dorman had no financial conflicts to disclos

CHICAGO - Older patients undergoing bariatric surgery had longer hospital stays, but no increased risk of death or major adverse events at 30 days, according to a study of more than 48,000 adults. The findings were presented at the annual Digestive Disease Week on May 9.

Patient age older than 65 years is not a contraindication to bariatric surgery, said Dr. Robert B. Dorman in a press conference in advance of the meeting. Previous studies of bariatric surgery in older adults have been limited to Medicare patients and have not included laparoscopic procedures, he noted.

In this multihospital study, Dr. Dorman of the University of Minnesota, Minneapolis, and his colleagues analyzed data from 48,378 adults with a body mass index of 35 kg/m2 or higher who underwent bariatric surgery between 2005 and 2009. The patients were part of the American College of Surgeons National Surgical Quality Improvement Program.

The types of surgery included open and laparoscopic Roux-en-Y gastric bypass, open duodenal switch, laparoscopic adjustable gastric banding, and vertical banded gastroplasty.

The percentage of bariatric surgery patients aged 65 years or older increased from 1.9% in 2005 to 4.8% in 2009, a significant change. Among all patients, a total of 72 deaths occurred during the study period, and 8 of these occurred in patients aged 65 years or older.

The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges. Specifically, for patients aged 35-49 years, 50-64 years, and 65 years and older mortality was 0.12%, 0.21%, and 0.40%, respectively. A multivariate analysis showed a trend for advancing age as a predictor of mortality, but this was not statistically significant, the researchers noted.

However, age of 65 years or older was a significant predictor of prolonged length of stay for both open and laparoscopic procedures. In addition, older age alone was not a significant predictor of major adverse events for either procedure type. The significant predictors of major adverse events included BMI of 55 or higher, cardiac comorbidities, severe ASA [American Society of Anesthesiologists] score, albumin levels less than 3 g/dL, and creatinine levels greater than 1.5 mg/dL.

“Once corroborated, these results [will] provide important information to patients, surgeons, hospitals, and payers prior to performing bariatric surgery in older persons with obesity,” Dr. Dorman said.

However, “we are certainly not giving the green light for bariatric surgeons to operate on these patients without determining their risk on an individual basis,” he added.

Dr. Dorman had no financial conflicts to disclos

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Major Finding: The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges.

Data Source: A multihospital study of 48,378 adults with a

body mass index of 35 kg/m2 or higher who underwent bariatric surgery during 2005 and 2009.

Disclosures: Dr. Dorman had no financial conflicts to disclose.

Age-Based Hep C Screening May Work Better Than Risk-Based Screening

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CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.

Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.

Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.

Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.

The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.

The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.

“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.

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The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec. 

*This story has been updated and new information has been added.

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CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.

Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.

Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.

Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.

The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.

The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.

“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.

I have checked the following facts in my story: (Please initial each.)

The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec. 

*This story has been updated and new information has been added.

CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.

Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.

Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.

Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.

The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.

The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.

“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.

I have checked the following facts in my story: (Please initial each.)

The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec. 

*This story has been updated and new information has been added.

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Age-Based Hep C Screening May Work Better Than Risk-Based Screening
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hepatitis C, risk-based screening, baby boomers, HCV infection, liver disease, cirrhosis, hepatocellular carcinoma, liver transplants
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FROM THE ANNUAL DIGESTIVE DISEASE WEEK

PURLs Copyright

Inside the Article

Vitals

Major Finding: BCS

would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer

cases of advanced liver disease, compared with RBS.

Data Source:

Investigators applied a Markov model to a population of approximately 102

million individuals who were eligible for HCV screening.

Disclosures: The

study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on

advisory committees or review panels for multiple pharmaceutical companies,

including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.

Age-Based Hep C Screening May Work Better Than Risk-Based Screening

How Does this Fit into Practice?
Article Type
Changed
Fri, 12/07/2018 - 13:56
Display Headline
Age-Based Hep C Screening May Work Better Than Risk-Based Screening

CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.

Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.

Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.

Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.

The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.

The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.

“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.

I have checked the following facts in my story: (Please initial each.)

The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec. 

*This story has been updated and new information has been added.

Body

It seems intuitive

that screening a cohort of patients, in this case those born between 1946 and

1964, for hepatitis C virus (HCV) infection, treating the ones infected, and

then following them for the next 6 to 34 years (until they reach age 70 years)

should find that the eventual prevalence of complications of end-stage liver

disease would be reduced when compared to the same cohort of patients only

tested for HCV infection when a risk factor for HCV infection is identified.

But how does this information help me as an individual practitioner? Should I

now screen all the “baby boomers” in my practice whether I have identified a

past risk for HCV infection or not? What about patients in other age cohorts?

And how do I reconcile this against the recommendation of the U.S. Preventive

Services Task Force that has yet to change its stand that the available data

doesn’t support HCV screening of high-risk individuals?

One thing that I

believe it does tell me is that we don’t always ask the right questions of our

patients and that patients don’t always remember or tell us about things of the

past that have put them at risk for HCV. Sometimes I simply show my patients a

list of risks and only ask if there is something on the list that might be

true. It saves them from having to own up to a specific event and yet it lets

me know they are at risk and should be screened. I wonder how that approach

would fare when studied.

Rowen K. Zetterman, M.D. is an internist

and gastroenterologist and dean of the Creighton

University School

of Medicine in Omaha, Neb. He serves on the editorial advisory

board for Internal

Medicine News. He reported having no conflicts of interest.

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Body

It seems intuitive

that screening a cohort of patients, in this case those born between 1946 and

1964, for hepatitis C virus (HCV) infection, treating the ones infected, and

then following them for the next 6 to 34 years (until they reach age 70 years)

should find that the eventual prevalence of complications of end-stage liver

disease would be reduced when compared to the same cohort of patients only

tested for HCV infection when a risk factor for HCV infection is identified.

But how does this information help me as an individual practitioner? Should I

now screen all the “baby boomers” in my practice whether I have identified a

past risk for HCV infection or not? What about patients in other age cohorts?

And how do I reconcile this against the recommendation of the U.S. Preventive

Services Task Force that has yet to change its stand that the available data

doesn’t support HCV screening of high-risk individuals?

One thing that I

believe it does tell me is that we don’t always ask the right questions of our

patients and that patients don’t always remember or tell us about things of the

past that have put them at risk for HCV. Sometimes I simply show my patients a

list of risks and only ask if there is something on the list that might be

true. It saves them from having to own up to a specific event and yet it lets

me know they are at risk and should be screened. I wonder how that approach

would fare when studied.

Rowen K. Zetterman, M.D. is an internist

and gastroenterologist and dean of the Creighton

University School

of Medicine in Omaha, Neb. He serves on the editorial advisory

board for Internal

Medicine News. He reported having no conflicts of interest.

Body

It seems intuitive

that screening a cohort of patients, in this case those born between 1946 and

1964, for hepatitis C virus (HCV) infection, treating the ones infected, and

then following them for the next 6 to 34 years (until they reach age 70 years)

should find that the eventual prevalence of complications of end-stage liver

disease would be reduced when compared to the same cohort of patients only

tested for HCV infection when a risk factor for HCV infection is identified.

But how does this information help me as an individual practitioner? Should I

now screen all the “baby boomers” in my practice whether I have identified a

past risk for HCV infection or not? What about patients in other age cohorts?

And how do I reconcile this against the recommendation of the U.S. Preventive

Services Task Force that has yet to change its stand that the available data

doesn’t support HCV screening of high-risk individuals?

One thing that I

believe it does tell me is that we don’t always ask the right questions of our

patients and that patients don’t always remember or tell us about things of the

past that have put them at risk for HCV. Sometimes I simply show my patients a

list of risks and only ask if there is something on the list that might be

true. It saves them from having to own up to a specific event and yet it lets

me know they are at risk and should be screened. I wonder how that approach

would fare when studied.

Rowen K. Zetterman, M.D. is an internist

and gastroenterologist and dean of the Creighton

University School

of Medicine in Omaha, Neb. He serves on the editorial advisory

board for Internal

Medicine News. He reported having no conflicts of interest.

Title
How Does this Fit into Practice?
How Does this Fit into Practice?

CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.

Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.

Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.

Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.

The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.

The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.

“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.

I have checked the following facts in my story: (Please initial each.)

The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec. 

*This story has been updated and new information has been added.

CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.

Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.

Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.

Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.

The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.

The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.

“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.

I have checked the following facts in my story: (Please initial each.)

The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec. 

*This story has been updated and new information has been added.

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Age-Based Hep C Screening May Work Better Than Risk-Based Screening
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hepatitis C, risk-based screening, baby boomers, HCV infection, liver disease, cirrhosis, hepatocellular carcinoma, liver transplants
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Article Source

FROM THE ANNUAL DIGESTIVE DISEASE WEEK

PURLs Copyright

Inside the Article

Vitals

Major Finding: BCS

would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer

cases of advanced liver disease, compared with RBS.

Data Source:

Investigators applied a Markov model to a population of approximately 102

million individuals who were eligible for HCV screening.

Disclosures: The

study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on

advisory committees or review panels for multiple pharmaceutical companies,

including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.

Moderate Exercise Can Reduce Colon Polyps by One-Third

Article Type
Changed
Fri, 12/07/2018 - 13:56
Display Headline
Moderate Exercise Can Reduce Colon Polyps by One-Third

In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

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In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

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Moderate Exercise Can Reduce Colon Polyps by One-Third
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FROM THE ANNUAL DIGESTIVE DISEASE WEEK

PURLs Copyright

Inside the Article

Vitals

Major Finding: Prevalence of polyps was significantly higher among patients who reported less

than 1 hour per week of exercise, compared with those who reported

exercising for 1 hour or more (33.2% vs. 25.3%).

Data Source: A prospective study of 982 middle-aged adults, all with an average risk for colorectal cancer. 

Disclosures: Dr. Sanchez said he had no financial conflicts to disclose.

Moderate Exercise Can Reduce Colon Polyps by One-Third

Article Type
Changed
Wed, 12/14/2016 - 10:29
Display Headline
Moderate Exercise Can Reduce Colon Polyps by One-Third

In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

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In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

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    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

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Moderate Exercise Can Reduce Colon Polyps by One-Third

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Moderate Exercise Can Reduce Colon Polyps by One-Third

In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

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In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.

"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.

(c)Monkey Business/Fotolia.com
    Prevalence of colon polyps was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%).

Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).

The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).

About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).

In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.

Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.

When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.

These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.

The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.

Dr. Sanchez said he had no financial conflicts to disclose.

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Major Finding: Prevalence of polyps was significantly higher among patients who reported less

than 1 hour per week of exercise, compared with those who reported

exercising for 1 hour or more (33.2% vs. 25.3%).

Data Source: A prospective study of 982 middle-aged adults, all with an average risk for colorectal cancer. 

Disclosures: Dr. Sanchez said he had no financial conflicts to disclose

Obesity Screening of Younger Children Leads to Better BMI, Lipids

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Intensive lifestyle intervention after obesity screening significantly improved body mass index z scores in children aged 2-5 years, compared with children aged 6-21 years, based on data from 462 children enrolled in a tertiary-care clinical obesity program.

"Children 2 to 5 years old responded nearly seven times more favorably than [did] older children aged 6 to 21 years old after completion of 6 months within our obesity program," Dr. Carl A. Sather of Indiana University, Indianapolis, said in a press conference. The complete study findings will be presented on May 9 at the annual Digestive Disease Week.

The findings contrast with the current U.S. Preventive Services Task Force guidelines, which suggest screening children aged 6-18 years (not younger) for obesity and referring them for comprehensive therapy if needed, he said.

The study population included 44 children aged 2-5 years and 418 children and adolescents aged 6-21 years. All participants were referred to the program and had a body mass index above the 95th percentile for age and sex, or had a BMI greater than the 85th percentile with comorbidities.

During the lifestyle intervention, changes in BMI z scores were significantly greater in the younger group, compared with the older group after 3 months (–0.23 vs. –0.05) and after 6 months (–0.64 vs. –0.094).

The 12-month program began with a 3-month clinic-based intervention that included sessions with a dietitian, physical therapist, child psychologist, and pediatrician. Children and their caregivers were taught behavior change techniques including goal setting, accountability, self-monitoring, and stimulus control.

The children and caregivers met in group sessions once a month during months 4-6 and bimonthly during months 7-12. Interventions included the use of a food journal and a pedometer. Program completion rates were similar between the younger and older groups at 3 months (43% vs. 44%) and 6 months (11% vs. 14%).

The mean age of the younger patients was 4.6 years, with a mean BMI z score at baseline of 3.46. The mean age of the older patients was 12.2 years, with a mean BMI z score at baseline of 2.55.

The baseline rate of dyslipidemia (HDL cholesterol less than 40 mg/dL) was similar in the younger vs. older groups (56% vs. 59%, respectively), and the baseline rate of transaminitis, or elevated levels of aspartate transaminase and alanine transaminase, also was similar for the two groups (7% vs. 7.5%, respectively). Follow-up lab testing for dyslipidemia at 6-12 months showed similar gains in HDL in both the younger and older groups (increases of 2.84 mg/dL vs. 2.00 mg/dL, respectively).

Although the findings suggest that obesity screening is appropriate for preschoolers, it is important for the parent or caregiver to monitor the use of pedometers and food/activity journals by the youngest children, Dr. Sather noted in an interview.

"We had to take some specific strategies to address developmental limitations in the 2- to 3-year-old group," he said. But pedometers can be used by children if they are monitored by adults, and the food and activity journal also can be used easily by young children with adult supervision, he said.

"We don’t see any reason that younger children should be excluded from behavioral interventions [for obesity]" said Dr. Sather. "Although our numbers are small, our completion rate is consistent with other centers," he said, and the data are sufficiently convincing to recommend that all children aged 2-18 years should receive obesity screening, similar to the American Academy of Pediatrics’ current recommendations. "We hope that our data will prompt some further research and examine the positive impacts of BMI screening at younger ages, and that it will contribute to stronger conclusions and healthier pediatric populations," he said.

Dr. Sather said he had no financial conflicts to disclose.

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Intensive lifestyle intervention after obesity screening significantly improved body mass index z scores in children aged 2-5 years, compared with children aged 6-21 years, based on data from 462 children enrolled in a tertiary-care clinical obesity program.

"Children 2 to 5 years old responded nearly seven times more favorably than [did] older children aged 6 to 21 years old after completion of 6 months within our obesity program," Dr. Carl A. Sather of Indiana University, Indianapolis, said in a press conference. The complete study findings will be presented on May 9 at the annual Digestive Disease Week.

The findings contrast with the current U.S. Preventive Services Task Force guidelines, which suggest screening children aged 6-18 years (not younger) for obesity and referring them for comprehensive therapy if needed, he said.

The study population included 44 children aged 2-5 years and 418 children and adolescents aged 6-21 years. All participants were referred to the program and had a body mass index above the 95th percentile for age and sex, or had a BMI greater than the 85th percentile with comorbidities.

During the lifestyle intervention, changes in BMI z scores were significantly greater in the younger group, compared with the older group after 3 months (–0.23 vs. –0.05) and after 6 months (–0.64 vs. –0.094).

The 12-month program began with a 3-month clinic-based intervention that included sessions with a dietitian, physical therapist, child psychologist, and pediatrician. Children and their caregivers were taught behavior change techniques including goal setting, accountability, self-monitoring, and stimulus control.

The children and caregivers met in group sessions once a month during months 4-6 and bimonthly during months 7-12. Interventions included the use of a food journal and a pedometer. Program completion rates were similar between the younger and older groups at 3 months (43% vs. 44%) and 6 months (11% vs. 14%).

The mean age of the younger patients was 4.6 years, with a mean BMI z score at baseline of 3.46. The mean age of the older patients was 12.2 years, with a mean BMI z score at baseline of 2.55.

The baseline rate of dyslipidemia (HDL cholesterol less than 40 mg/dL) was similar in the younger vs. older groups (56% vs. 59%, respectively), and the baseline rate of transaminitis, or elevated levels of aspartate transaminase and alanine transaminase, also was similar for the two groups (7% vs. 7.5%, respectively). Follow-up lab testing for dyslipidemia at 6-12 months showed similar gains in HDL in both the younger and older groups (increases of 2.84 mg/dL vs. 2.00 mg/dL, respectively).

Although the findings suggest that obesity screening is appropriate for preschoolers, it is important for the parent or caregiver to monitor the use of pedometers and food/activity journals by the youngest children, Dr. Sather noted in an interview.

"We had to take some specific strategies to address developmental limitations in the 2- to 3-year-old group," he said. But pedometers can be used by children if they are monitored by adults, and the food and activity journal also can be used easily by young children with adult supervision, he said.

"We don’t see any reason that younger children should be excluded from behavioral interventions [for obesity]" said Dr. Sather. "Although our numbers are small, our completion rate is consistent with other centers," he said, and the data are sufficiently convincing to recommend that all children aged 2-18 years should receive obesity screening, similar to the American Academy of Pediatrics’ current recommendations. "We hope that our data will prompt some further research and examine the positive impacts of BMI screening at younger ages, and that it will contribute to stronger conclusions and healthier pediatric populations," he said.

Dr. Sather said he had no financial conflicts to disclose.

Intensive lifestyle intervention after obesity screening significantly improved body mass index z scores in children aged 2-5 years, compared with children aged 6-21 years, based on data from 462 children enrolled in a tertiary-care clinical obesity program.

"Children 2 to 5 years old responded nearly seven times more favorably than [did] older children aged 6 to 21 years old after completion of 6 months within our obesity program," Dr. Carl A. Sather of Indiana University, Indianapolis, said in a press conference. The complete study findings will be presented on May 9 at the annual Digestive Disease Week.

The findings contrast with the current U.S. Preventive Services Task Force guidelines, which suggest screening children aged 6-18 years (not younger) for obesity and referring them for comprehensive therapy if needed, he said.

The study population included 44 children aged 2-5 years and 418 children and adolescents aged 6-21 years. All participants were referred to the program and had a body mass index above the 95th percentile for age and sex, or had a BMI greater than the 85th percentile with comorbidities.

During the lifestyle intervention, changes in BMI z scores were significantly greater in the younger group, compared with the older group after 3 months (–0.23 vs. –0.05) and after 6 months (–0.64 vs. –0.094).

The 12-month program began with a 3-month clinic-based intervention that included sessions with a dietitian, physical therapist, child psychologist, and pediatrician. Children and their caregivers were taught behavior change techniques including goal setting, accountability, self-monitoring, and stimulus control.

The children and caregivers met in group sessions once a month during months 4-6 and bimonthly during months 7-12. Interventions included the use of a food journal and a pedometer. Program completion rates were similar between the younger and older groups at 3 months (43% vs. 44%) and 6 months (11% vs. 14%).

The mean age of the younger patients was 4.6 years, with a mean BMI z score at baseline of 3.46. The mean age of the older patients was 12.2 years, with a mean BMI z score at baseline of 2.55.

The baseline rate of dyslipidemia (HDL cholesterol less than 40 mg/dL) was similar in the younger vs. older groups (56% vs. 59%, respectively), and the baseline rate of transaminitis, or elevated levels of aspartate transaminase and alanine transaminase, also was similar for the two groups (7% vs. 7.5%, respectively). Follow-up lab testing for dyslipidemia at 6-12 months showed similar gains in HDL in both the younger and older groups (increases of 2.84 mg/dL vs. 2.00 mg/dL, respectively).

Although the findings suggest that obesity screening is appropriate for preschoolers, it is important for the parent or caregiver to monitor the use of pedometers and food/activity journals by the youngest children, Dr. Sather noted in an interview.

"We had to take some specific strategies to address developmental limitations in the 2- to 3-year-old group," he said. But pedometers can be used by children if they are monitored by adults, and the food and activity journal also can be used easily by young children with adult supervision, he said.

"We don’t see any reason that younger children should be excluded from behavioral interventions [for obesity]" said Dr. Sather. "Although our numbers are small, our completion rate is consistent with other centers," he said, and the data are sufficiently convincing to recommend that all children aged 2-18 years should receive obesity screening, similar to the American Academy of Pediatrics’ current recommendations. "We hope that our data will prompt some further research and examine the positive impacts of BMI screening at younger ages, and that it will contribute to stronger conclusions and healthier pediatric populations," he said.

Dr. Sather said he had no financial conflicts to disclose.

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FROM DIGESTIVE DISEASE WEEK

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Major Finding: Lifestyle intervention after obesity screening led to significantly greater reductions in body mass index among children aged 2-5 years, compared to children aged 6-21 years.

Data Source: Data from 462 obese children aged 2-21 years.

Disclosures: Dr. Sather said he had no financial conflicts to disclose.