Mary Ann Moon

A statewide Arizona program that officially endorsed chest-compression-only CPR significantly increased rates of bystander CPR and of patient survival in cases of cardiac arrest, according to a new report in the Oct. 6 issue of JAMA.

“Encouraging a technique that is easier to perform and more acceptable to the public may have helped increase the CPR rate independent of the public education efforts,” said Dr. Bentley J. Bobrow of the Arizona Department of Health Services, Phoenix, and his associates.

Nationally, bystander CPR of any kind is performed in less than 30% of cases. It is thought that bystanders refrain from providing conventional CPR for a variety of reasons, including fear of causing harm, fear of contracting infectious disease, the complexity of the psychomotor task, panic, and reluctance to make mouth-to-mouth contact, they noted.

Beginning in 2005, the investigators conducted a 5-year prospective, observational cohort study to evaluate the effects of implementing the state program, which advocated compression-only CPR through many types of training and information dissemination. “We estimate that at least 30,000 people have been directly trained in the [compression-only] technique and that more than 500,000 were exposed to at least one media forum,” Dr. Bobrow and his colleagues said (JAMA 2010;304:1447-54).

Emergency medical services personnel who responded to calls for out-of-hospital cardiac arrests recorded whether bystanders performed resuscitative measures and which techniques they used. The researchers then assessed outcomes for 4,415 cases that occurred during the next 5 years.

In 2,900 of those cases, there was no bystander CPR. Lay bystanders performed conventional CPR in 666 cases (15%) and compression-only CPR in 849 cases (19%). The overall survival rate was 7%.

After the program was implemented, the rate of lay bystanders performing any type of CPR rose significantly, from 28% at the beginning of the study to 40% at the end of the study period.

The proportion of bystander compression-only CPR attempts rose dramatically, from approximately 20% in 2005 to 76% at the end of 2009, the investigators said.

Survival increased concomitantly, from 3.7% at baseline to 9.8% at the end of the study. Both types of bystander CPR were associated with improved survival, compared with no bystander CPR.

In the subgroup of 1,017 patients with the best prognoses – those whose cardiac arrest was witnessed by a lay bystander and who had a shockable rhythm when the EMS arrived – survival was 17.6% with no CPR and 17.7% with conventional CPR, compared with 33.7% with compression-only CPR.

In addition, survivors attained good neurologic outcomes in 62 of 814 cases with bystander compression-only CPR (7.6%), compared with 34 of 651 cases with bystander conventional CPR (5.2%). That difference was small but significant, Dr. Bobrow and his associates said.

Disclosures: Dr. Cone reported no financial conflicts.

A statewide Arizona program that officially endorsed chest-compression-only CPR significantly increased rates of bystander CPR and of patient survival in cases of cardiac arrest, according to a new report in the Oct. 6 issue of JAMA.

“Encouraging a technique that is easier to perform and more acceptable to the public may have helped increase the CPR rate independent of the public education efforts,” said Dr. Bentley J. Bobrow of the Arizona Department of Health Services, Phoenix, and his associates.

Nationally, bystander CPR of any kind is performed in less than 30% of cases. It is thought that bystanders refrain from providing conventional CPR for a variety of reasons, including fear of causing harm, fear of contracting infectious disease, the complexity of the psychomotor task, panic, and reluctance to make mouth-to-mouth contact, they noted.

Beginning in 2005, the investigators conducted a 5-year prospective, observational cohort study to evaluate the effects of implementing the state program, which advocated compression-only CPR through many types of training and information dissemination. “We estimate that at least 30,000 people have been directly trained in the [compression-only] technique and that more than 500,000 were exposed to at least one media forum,” Dr. Bobrow and his colleagues said (JAMA 2010;304:1447-54).

Emergency medical services personnel who responded to calls for out-of-hospital cardiac arrests recorded whether bystanders performed resuscitative measures and which techniques they used. The researchers then assessed outcomes for 4,415 cases that occurred during the next 5 years.

In 2,900 of those cases, there was no bystander CPR. Lay bystanders performed conventional CPR in 666 cases (15%) and compression-only CPR in 849 cases (19%). The overall survival rate was 7%.

After the program was implemented, the rate of lay bystanders performing any type of CPR rose significantly, from 28% at the beginning of the study to 40% at the end of the study period.

The proportion of bystander compression-only CPR attempts rose dramatically, from approximately 20% in 2005 to 76% at the end of 2009, the investigators said.

Survival increased concomitantly, from 3.7% at baseline to 9.8% at the end of the study. Both types of bystander CPR were associated with improved survival, compared with no bystander CPR.

In the subgroup of 1,017 patients with the best prognoses – those whose cardiac arrest was witnessed by a lay bystander and who had a shockable rhythm when the EMS arrived – survival was 17.6% with no CPR and 17.7% with conventional CPR, compared with 33.7% with compression-only CPR.

In addition, survivors attained good neurologic outcomes in 62 of 814 cases with bystander compression-only CPR (7.6%), compared with 34 of 651 cases with bystander conventional CPR (5.2%). That difference was small but significant, Dr. Bobrow and his associates said.

Disclosures: Dr. Cone reported no financial conflicts.

A statewide Arizona program that officially endorsed chest-compression-only CPR significantly increased rates of bystander CPR and of patient survival in cases of cardiac arrest, according to a new report in the Oct. 6 issue of JAMA.

“Encouraging a technique that is easier to perform and more acceptable to the public may have helped increase the CPR rate independent of the public education efforts,” said Dr. Bentley J. Bobrow of the Arizona Department of Health Services, Phoenix, and his associates.

Nationally, bystander CPR of any kind is performed in less than 30% of cases. It is thought that bystanders refrain from providing conventional CPR for a variety of reasons, including fear of causing harm, fear of contracting infectious disease, the complexity of the psychomotor task, panic, and reluctance to make mouth-to-mouth contact, they noted.

Beginning in 2005, the investigators conducted a 5-year prospective, observational cohort study to evaluate the effects of implementing the state program, which advocated compression-only CPR through many types of training and information dissemination. “We estimate that at least 30,000 people have been directly trained in the [compression-only] technique and that more than 500,000 were exposed to at least one media forum,” Dr. Bobrow and his colleagues said (JAMA 2010;304:1447-54).

Emergency medical services personnel who responded to calls for out-of-hospital cardiac arrests recorded whether bystanders performed resuscitative measures and which techniques they used. The researchers then assessed outcomes for 4,415 cases that occurred during the next 5 years.

In 2,900 of those cases, there was no bystander CPR. Lay bystanders performed conventional CPR in 666 cases (15%) and compression-only CPR in 849 cases (19%). The overall survival rate was 7%.

After the program was implemented, the rate of lay bystanders performing any type of CPR rose significantly, from 28% at the beginning of the study to 40% at the end of the study period.

The proportion of bystander compression-only CPR attempts rose dramatically, from approximately 20% in 2005 to 76% at the end of 2009, the investigators said.

Survival increased concomitantly, from 3.7% at baseline to 9.8% at the end of the study. Both types of bystander CPR were associated with improved survival, compared with no bystander CPR.

In the subgroup of 1,017 patients with the best prognoses – those whose cardiac arrest was witnessed by a lay bystander and who had a shockable rhythm when the EMS arrived – survival was 17.6% with no CPR and 17.7% with conventional CPR, compared with 33.7% with compression-only CPR.

In addition, survivors attained good neurologic outcomes in 62 of 814 cases with bystander compression-only CPR (7.6%), compared with 34 of 651 cases with bystander conventional CPR (5.2%). That difference was small but significant, Dr. Bobrow and his associates said.

Disclosures: Dr. Cone reported no financial conflicts.

Despite recent reports that the intranasal live attenuated influenza vaccine might cause more adverse events in young children than does the inactivated influenza vaccine, the cost-effectiveness of the two approaches remains comparable, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Louise A. Koenig

In a mathematical simulation model, both the live attenuated vaccine and the inactivated vaccine yielded similar cost-effectiveness ratios of less than $40,000 per quality-adjusted life year (QALY) among children under 5 years, which compares well with other well-accepted pediatric interventions, said Lisa A. Prosser, Ph.D., of the University of Michigan Health System, Ann Arbor, and her associates.

The investigators assessed the cost-effectiveness of each of the vaccines and of no vaccination using a mathematical simulation model that estimated the effects on influenza-related health outcomes in a hypothetical cohort of healthy children aged 6 months to 4 years. They had previously reported that the same model showed comparable cost-effectiveness between the two vaccine strategies in 2006. They now report their results using the same simulation program but incorporating more recent epidemiologic data on adverse events such as wheezing and fever and on the costs of influenza-related hospitalizations.

In this low-risk hypothetical population, under a wide range of assumptions, the live attenuated vaccine was projected to avert more episodes of influenza, influenza-related hospitalizations, and deaths than was the inactivated vaccine. However, this benefit was somewhat counterbalanced by increase in adverse events with the live attenuated vaccine.

Nevertheless, either vaccine strategy yielded a net health benefit, compared with no vaccination, as measured by quality of life-years gained, Dr. Prosser and her colleagues said (Arch. Pediatr. Adolesc. Med. 2010 [doi:10.1001/archpediatrics.2010.182]).

Under different conditions, the model showed that cost-effectiveness ratios ranged from $20,000/QALY to $33,000/QALY with the live attenuated vaccine. Similarly, cost-effectiveness ratios ranged from $21,000/QALY to $37,000/QALY with the inactivated vaccine.

“One potential limitation of this analysis is the exclusion of herd immunity effects. If these effects were considered, they would likely result in more favorable cost-effectiveness ratios for [both] vaccination options,” the investigators added.

Disclosures: This study was funded by the Centers for Disease Control and Prevention through the Harvard/CDC Joint Initiative in Vaccine Economics. No financial conflicts of interest were reported.

Despite recent reports that the intranasal live attenuated influenza vaccine might cause more adverse events in young children than does the inactivated influenza vaccine, the cost-effectiveness of the two approaches remains comparable, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Louise A. Koenig

In a mathematical simulation model, both the live attenuated vaccine and the inactivated vaccine yielded similar cost-effectiveness ratios of less than $40,000 per quality-adjusted life year (QALY) among children under 5 years, which compares well with other well-accepted pediatric interventions, said Lisa A. Prosser, Ph.D., of the University of Michigan Health System, Ann Arbor, and her associates.

The investigators assessed the cost-effectiveness of each of the vaccines and of no vaccination using a mathematical simulation model that estimated the effects on influenza-related health outcomes in a hypothetical cohort of healthy children aged 6 months to 4 years. They had previously reported that the same model showed comparable cost-effectiveness between the two vaccine strategies in 2006. They now report their results using the same simulation program but incorporating more recent epidemiologic data on adverse events such as wheezing and fever and on the costs of influenza-related hospitalizations.

In this low-risk hypothetical population, under a wide range of assumptions, the live attenuated vaccine was projected to avert more episodes of influenza, influenza-related hospitalizations, and deaths than was the inactivated vaccine. However, this benefit was somewhat counterbalanced by increase in adverse events with the live attenuated vaccine.

Nevertheless, either vaccine strategy yielded a net health benefit, compared with no vaccination, as measured by quality of life-years gained, Dr. Prosser and her colleagues said (Arch. Pediatr. Adolesc. Med. 2010 [doi:10.1001/archpediatrics.2010.182]).

Under different conditions, the model showed that cost-effectiveness ratios ranged from $20,000/QALY to $33,000/QALY with the live attenuated vaccine. Similarly, cost-effectiveness ratios ranged from $21,000/QALY to $37,000/QALY with the inactivated vaccine.

“One potential limitation of this analysis is the exclusion of herd immunity effects. If these effects were considered, they would likely result in more favorable cost-effectiveness ratios for [both] vaccination options,” the investigators added.

Disclosures: This study was funded by the Centers for Disease Control and Prevention through the Harvard/CDC Joint Initiative in Vaccine Economics. No financial conflicts of interest were reported.

Despite recent reports that the intranasal live attenuated influenza vaccine might cause more adverse events in young children than does the inactivated influenza vaccine, the cost-effectiveness of the two approaches remains comparable, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Louise A. Koenig

In a mathematical simulation model, both the live attenuated vaccine and the inactivated vaccine yielded similar cost-effectiveness ratios of less than $40,000 per quality-adjusted life year (QALY) among children under 5 years, which compares well with other well-accepted pediatric interventions, said Lisa A. Prosser, Ph.D., of the University of Michigan Health System, Ann Arbor, and her associates.

The investigators assessed the cost-effectiveness of each of the vaccines and of no vaccination using a mathematical simulation model that estimated the effects on influenza-related health outcomes in a hypothetical cohort of healthy children aged 6 months to 4 years. They had previously reported that the same model showed comparable cost-effectiveness between the two vaccine strategies in 2006. They now report their results using the same simulation program but incorporating more recent epidemiologic data on adverse events such as wheezing and fever and on the costs of influenza-related hospitalizations.

In this low-risk hypothetical population, under a wide range of assumptions, the live attenuated vaccine was projected to avert more episodes of influenza, influenza-related hospitalizations, and deaths than was the inactivated vaccine. However, this benefit was somewhat counterbalanced by increase in adverse events with the live attenuated vaccine.

Nevertheless, either vaccine strategy yielded a net health benefit, compared with no vaccination, as measured by quality of life-years gained, Dr. Prosser and her colleagues said (Arch. Pediatr. Adolesc. Med. 2010 [doi:10.1001/archpediatrics.2010.182]).

Under different conditions, the model showed that cost-effectiveness ratios ranged from $20,000/QALY to $33,000/QALY with the live attenuated vaccine. Similarly, cost-effectiveness ratios ranged from $21,000/QALY to $37,000/QALY with the inactivated vaccine.

“One potential limitation of this analysis is the exclusion of herd immunity effects. If these effects were considered, they would likely result in more favorable cost-effectiveness ratios for [both] vaccination options,” the investigators added.

Disclosures: This study was funded by the Centers for Disease Control and Prevention through the Harvard/CDC Joint Initiative in Vaccine Economics. No financial conflicts of interest were reported.

Despite recent reports that the intranasal live attenuated influenza vaccine might cause more adverse events in young children than does the inactivated influenza vaccine, the cost-effectiveness of the two approaches remains comparable, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Louise A. Koenig

In a mathematical simulation model, both the live attenuated vaccine and the inactivated vaccine yielded similar cost-effectiveness ratios of less than $40,000 per quality-adjusted life year (QALY) among children under 5 years, which compares well with other well-accepted pediatric interventions, said Lisa A. Prosser, Ph.D., of the University of Michigan Health System, Ann Arbor, and her associates.

The investigators assessed the cost-effectiveness of each of the vaccines and of no vaccination using a mathematical simulation model that estimated the effects on influenza-related health outcomes in a hypothetical cohort of healthy children aged 6 months to 4 years. They had previously reported that the same model showed comparable cost-effectiveness between the two vaccine strategies in 2006. They now report their results using the same simulation program but incorporating more recent epidemiologic data on adverse events such as wheezing and fever and on the costs of influenza-related hospitalizations.

In this low-risk hypothetical population, under a wide range of assumptions, the live attenuated vaccine was projected to avert more episodes of influenza, influenza-related hospitalizations, and deaths than was the inactivated vaccine. However, this benefit was somewhat counterbalanced by increase in adverse events with the live attenuated vaccine.

Nevertheless, either vaccine strategy yielded a net health benefit, compared with no vaccination, as measured by quality of life-years gained, Dr. Prosser and her colleagues said (Arch. Pediatr. Adolesc. Med. 2010 [doi:10.1001/archpediatrics.2010.182]).

Under different conditions, the model showed that cost-effectiveness ratios ranged from $20,000/QALY to $33,000/QALY with the live attenuated vaccine. Similarly, cost-effectiveness ratios ranged from $21,000/QALY to $37,000/QALY with the inactivated vaccine.

“One potential limitation of this analysis is the exclusion of herd immunity effects. If these effects were considered, they would likely result in more favorable cost-effectiveness ratios for [both] vaccination options,” the investigators added.

Disclosures: This study was funded by the Centers for Disease Control and Prevention through the Harvard/CDC Joint Initiative in Vaccine Economics. No financial conflicts of interest were reported.

Despite recent reports that the intranasal live attenuated influenza vaccine might cause more adverse events in young children than does the inactivated influenza vaccine, the cost-effectiveness of the two approaches remains comparable, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Louise A. Koenig

In a mathematical simulation model, both the live attenuated vaccine and the inactivated vaccine yielded similar cost-effectiveness ratios of less than $40,000 per quality-adjusted life year (QALY) among children under 5 years, which compares well with other well-accepted pediatric interventions, said Lisa A. Prosser, Ph.D., of the University of Michigan Health System, Ann Arbor, and her associates.

The investigators assessed the cost-effectiveness of each of the vaccines and of no vaccination using a mathematical simulation model that estimated the effects on influenza-related health outcomes in a hypothetical cohort of healthy children aged 6 months to 4 years. They had previously reported that the same model showed comparable cost-effectiveness between the two vaccine strategies in 2006. They now report their results using the same simulation program but incorporating more recent epidemiologic data on adverse events such as wheezing and fever and on the costs of influenza-related hospitalizations.

In this low-risk hypothetical population, under a wide range of assumptions, the live attenuated vaccine was projected to avert more episodes of influenza, influenza-related hospitalizations, and deaths than was the inactivated vaccine. However, this benefit was somewhat counterbalanced by increase in adverse events with the live attenuated vaccine.

Nevertheless, either vaccine strategy yielded a net health benefit, compared with no vaccination, as measured by quality of life-years gained, Dr. Prosser and her colleagues said (Arch. Pediatr. Adolesc. Med. 2010 [doi:10.1001/archpediatrics.2010.182]).

Under different conditions, the model showed that cost-effectiveness ratios ranged from $20,000/QALY to $33,000/QALY with the live attenuated vaccine. Similarly, cost-effectiveness ratios ranged from $21,000/QALY to $37,000/QALY with the inactivated vaccine.

“One potential limitation of this analysis is the exclusion of herd immunity effects. If these effects were considered, they would likely result in more favorable cost-effectiveness ratios for [both] vaccination options,” the investigators added.

Disclosures: This study was funded by the Centers for Disease Control and Prevention through the Harvard/CDC Joint Initiative in Vaccine Economics. No financial conflicts of interest were reported.

Despite recent reports that the intranasal live attenuated influenza vaccine might cause more adverse events in young children than does the inactivated influenza vaccine, the cost-effectiveness of the two approaches remains comparable, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Louise A. Koenig

In a mathematical simulation model, both the live attenuated vaccine and the inactivated vaccine yielded similar cost-effectiveness ratios of less than $40,000 per quality-adjusted life year (QALY) among children under 5 years, which compares well with other well-accepted pediatric interventions, said Lisa A. Prosser, Ph.D., of the University of Michigan Health System, Ann Arbor, and her associates.

The investigators assessed the cost-effectiveness of each of the vaccines and of no vaccination using a mathematical simulation model that estimated the effects on influenza-related health outcomes in a hypothetical cohort of healthy children aged 6 months to 4 years. They had previously reported that the same model showed comparable cost-effectiveness between the two vaccine strategies in 2006. They now report their results using the same simulation program but incorporating more recent epidemiologic data on adverse events such as wheezing and fever and on the costs of influenza-related hospitalizations.

In this low-risk hypothetical population, under a wide range of assumptions, the live attenuated vaccine was projected to avert more episodes of influenza, influenza-related hospitalizations, and deaths than was the inactivated vaccine. However, this benefit was somewhat counterbalanced by increase in adverse events with the live attenuated vaccine.

Nevertheless, either vaccine strategy yielded a net health benefit, compared with no vaccination, as measured by quality of life-years gained, Dr. Prosser and her colleagues said (Arch. Pediatr. Adolesc. Med. 2010 [doi:10.1001/archpediatrics.2010.182]).

Under different conditions, the model showed that cost-effectiveness ratios ranged from $20,000/QALY to $33,000/QALY with the live attenuated vaccine. Similarly, cost-effectiveness ratios ranged from $21,000/QALY to $37,000/QALY with the inactivated vaccine.

“One potential limitation of this analysis is the exclusion of herd immunity effects. If these effects were considered, they would likely result in more favorable cost-effectiveness ratios for [both] vaccination options,” the investigators added.

Disclosures: This study was funded by the Centers for Disease Control and Prevention through the Harvard/CDC Joint Initiative in Vaccine Economics. No financial conflicts of interest were reported.

Vaccinating pregnant women against seasonal influenza reduced the risk of laboratory-confirmed influenza infection in their infants by 41%, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Maternal immunization similarly cut by 39% the risk that infants up to 6 months of age would be hospitalized for influenza-like illness, said Angelia A. Eick, Ph.D., of the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

Influenza vaccination is already recommended for pregnant women to reduce their risk of developing flu-related complications. “These findings provide support for the added benefit of protecting infants from influenza virus infection up to 6 months, the period when infants are not eligible for influenza vaccination but are at highest risk of severe influenza illness,” the investigators noted.

Even though such immunization is recommended during pregnancy, it is not well accepted in the United States and many pregnant women do not get vaccinated. Since it would be unethical to perform a randomized, controlled study of maternal vaccination, Dr. Eick and her colleagues conducted a nonrandomized observational study to assess whether immunization during pregnancy conferred protection to infants.

The study subjects were 1,160 mother-infant pairs in which approximately half the mothers (573) had chosen to receive seasonal flu vaccine while pregnant and the other half (587) had declined the vaccine. All were enrolled after delivering healthy singleton infants at 7 hospitals serving the Navajo and White Mountain Apache Indian reservations in the southwestern United States during three flu seasons between 2002 and 2005.

A total of 605 infants developed influenza-like illness during the flu season following delivery. “We found a 41% reduction in the risk of laboratory-confirmed influenza virus infection for infants of influenza-vaccinated mothers compared with infants of unvaccinated mothers,” the researchers said (Arch Pediatr. Adolesc. Med. 2010 [doi10.1001/archpediatrics.2010.192]).

The incidence of influenza-like illness was 6.7 per 1,000 person-days for infants of mothers who had been vaccinated, compared with 7.2 per 1,000 person-days for infants of mothers who had not.

Among the infants whose mothers were vaccinated, there was a 41% reduction in the risk of laboratory-confirmed influenza virus infection compared with those whose mothers declined vaccination.

When the analysis was restricted only to cases of influenza that required hospitalization, a 39% reduction in risk was found for infants of women who had been vaccinated, compared with those of mothers who had not been vaccinated.

Cord blood samples or infant blood samples taken at 2-3 months of age were available for 160 study subjects. In this subgroup, the risk of influenza infection declined with increasing antibody titers.

The exact mechanism by which vaccination of the mother conferred protection to the infant is not certain. It may be due to maternal influenza antibodies being acquired transplacentally or through breastfeeding, or to reduced infant exposure to influenza in the mother. It even could be due to residual confounding not accounted for in the statistical analyses, but the finding of significantly higher antibody titers in 2- to 3-month-old infants who did not develop illness argues against that possibility, Dr. Eick and her colleagues said.

Disclosures: The study was funded by the U.S. Department of Health and Human Services’ National Vaccine Program Office, the Office of Minority and Women’s Health (now the Office of Health Disparities), the Centers for Disease Control and Prevention, Aventis-Pasteur, and Evans-Powderject. One of Dr. Eick’s associates reported ties with MedImmune, Pfizer, and Sanofi-Pasteur, all of which manufacture influenza vaccine.

Vaccinating pregnant women against seasonal influenza reduced the risk of laboratory-confirmed influenza infection in their infants by 41%, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Maternal immunization similarly cut by 39% the risk that infants up to 6 months of age would be hospitalized for influenza-like illness, said Angelia A. Eick, Ph.D., of the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

Influenza vaccination is already recommended for pregnant women to reduce their risk of developing flu-related complications. “These findings provide support for the added benefit of protecting infants from influenza virus infection up to 6 months, the period when infants are not eligible for influenza vaccination but are at highest risk of severe influenza illness,” the investigators noted.

Even though such immunization is recommended during pregnancy, it is not well accepted in the United States and many pregnant women do not get vaccinated. Since it would be unethical to perform a randomized, controlled study of maternal vaccination, Dr. Eick and her colleagues conducted a nonrandomized observational study to assess whether immunization during pregnancy conferred protection to infants.

The study subjects were 1,160 mother-infant pairs in which approximately half the mothers (573) had chosen to receive seasonal flu vaccine while pregnant and the other half (587) had declined the vaccine. All were enrolled after delivering healthy singleton infants at 7 hospitals serving the Navajo and White Mountain Apache Indian reservations in the southwestern United States during three flu seasons between 2002 and 2005.

A total of 605 infants developed influenza-like illness during the flu season following delivery. “We found a 41% reduction in the risk of laboratory-confirmed influenza virus infection for infants of influenza-vaccinated mothers compared with infants of unvaccinated mothers,” the researchers said (Arch Pediatr. Adolesc. Med. 2010 [doi10.1001/archpediatrics.2010.192]).

The incidence of influenza-like illness was 6.7 per 1,000 person-days for infants of mothers who had been vaccinated, compared with 7.2 per 1,000 person-days for infants of mothers who had not.

Among the infants whose mothers were vaccinated, there was a 41% reduction in the risk of laboratory-confirmed influenza virus infection compared with those whose mothers declined vaccination.

When the analysis was restricted only to cases of influenza that required hospitalization, a 39% reduction in risk was found for infants of women who had been vaccinated, compared with those of mothers who had not been vaccinated.

Cord blood samples or infant blood samples taken at 2-3 months of age were available for 160 study subjects. In this subgroup, the risk of influenza infection declined with increasing antibody titers.

The exact mechanism by which vaccination of the mother conferred protection to the infant is not certain. It may be due to maternal influenza antibodies being acquired transplacentally or through breastfeeding, or to reduced infant exposure to influenza in the mother. It even could be due to residual confounding not accounted for in the statistical analyses, but the finding of significantly higher antibody titers in 2- to 3-month-old infants who did not develop illness argues against that possibility, Dr. Eick and her colleagues said.

Disclosures: The study was funded by the U.S. Department of Health and Human Services’ National Vaccine Program Office, the Office of Minority and Women’s Health (now the Office of Health Disparities), the Centers for Disease Control and Prevention, Aventis-Pasteur, and Evans-Powderject. One of Dr. Eick’s associates reported ties with MedImmune, Pfizer, and Sanofi-Pasteur, all of which manufacture influenza vaccine.

Vaccinating pregnant women against seasonal influenza reduced the risk of laboratory-confirmed influenza infection in their infants by 41%, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Maternal immunization similarly cut by 39% the risk that infants up to 6 months of age would be hospitalized for influenza-like illness, said Angelia A. Eick, Ph.D., of the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

Influenza vaccination is already recommended for pregnant women to reduce their risk of developing flu-related complications. “These findings provide support for the added benefit of protecting infants from influenza virus infection up to 6 months, the period when infants are not eligible for influenza vaccination but are at highest risk of severe influenza illness,” the investigators noted.

Even though such immunization is recommended during pregnancy, it is not well accepted in the United States and many pregnant women do not get vaccinated. Since it would be unethical to perform a randomized, controlled study of maternal vaccination, Dr. Eick and her colleagues conducted a nonrandomized observational study to assess whether immunization during pregnancy conferred protection to infants.

The study subjects were 1,160 mother-infant pairs in which approximately half the mothers (573) had chosen to receive seasonal flu vaccine while pregnant and the other half (587) had declined the vaccine. All were enrolled after delivering healthy singleton infants at 7 hospitals serving the Navajo and White Mountain Apache Indian reservations in the southwestern United States during three flu seasons between 2002 and 2005.

A total of 605 infants developed influenza-like illness during the flu season following delivery. “We found a 41% reduction in the risk of laboratory-confirmed influenza virus infection for infants of influenza-vaccinated mothers compared with infants of unvaccinated mothers,” the researchers said (Arch Pediatr. Adolesc. Med. 2010 [doi10.1001/archpediatrics.2010.192]).

The incidence of influenza-like illness was 6.7 per 1,000 person-days for infants of mothers who had been vaccinated, compared with 7.2 per 1,000 person-days for infants of mothers who had not.

Among the infants whose mothers were vaccinated, there was a 41% reduction in the risk of laboratory-confirmed influenza virus infection compared with those whose mothers declined vaccination.

When the analysis was restricted only to cases of influenza that required hospitalization, a 39% reduction in risk was found for infants of women who had been vaccinated, compared with those of mothers who had not been vaccinated.

Cord blood samples or infant blood samples taken at 2-3 months of age were available for 160 study subjects. In this subgroup, the risk of influenza infection declined with increasing antibody titers.

The exact mechanism by which vaccination of the mother conferred protection to the infant is not certain. It may be due to maternal influenza antibodies being acquired transplacentally or through breastfeeding, or to reduced infant exposure to influenza in the mother. It even could be due to residual confounding not accounted for in the statistical analyses, but the finding of significantly higher antibody titers in 2- to 3-month-old infants who did not develop illness argues against that possibility, Dr. Eick and her colleagues said.

Disclosures: The study was funded by the U.S. Department of Health and Human Services’ National Vaccine Program Office, the Office of Minority and Women’s Health (now the Office of Health Disparities), the Centers for Disease Control and Prevention, Aventis-Pasteur, and Evans-Powderject. One of Dr. Eick’s associates reported ties with MedImmune, Pfizer, and Sanofi-Pasteur, all of which manufacture influenza vaccine.

Vaccinating pregnant women against seasonal influenza reduced the risk of laboratory-confirmed influenza infection in their infants by 41%, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Maternal immunization similarly cut by 39% the risk that infants up to 6 months of age would be hospitalized for influenza-like illness, said Angelia A. Eick, Ph.D., of the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

Influenza vaccination is already recommended for pregnant women to reduce their risk of developing flu-related complications. “These findings provide support for the added benefit of protecting infants from influenza virus infection up to 6 months, the period when infants are not eligible for influenza vaccination but are at highest risk of severe influenza illness,” the investigators noted.

Even though such immunization is recommended during pregnancy, it is not well accepted in the United States and many pregnant women do not get vaccinated. Since it would be unethical to perform a randomized, controlled study of maternal vaccination, Dr. Eick and her colleagues conducted a nonrandomized observational study to assess whether immunization during pregnancy conferred protection to infants.

The study subjects were 1,160 mother-infant pairs in which approximately half the mothers (573) had chosen to receive seasonal flu vaccine while pregnant and the other half (587) had declined the vaccine. All were enrolled after delivering healthy singleton infants at 7 hospitals serving the Navajo and White Mountain Apache Indian reservations in the southwestern United States during three flu seasons between 2002 and 2005.

A total of 605 infants developed influenza-like illness during the flu season following delivery. “We found a 41% reduction in the risk of laboratory-confirmed influenza virus infection for infants of influenza-vaccinated mothers compared with infants of unvaccinated mothers,” the researchers said (Arch Pediatr. Adolesc. Med. 2010 [doi10.1001/archpediatrics.2010.192]).

The incidence of influenza-like illness was 6.7 per 1,000 person-days for infants of mothers who had been vaccinated, compared with 7.2 per 1,000 person-days for infants of mothers who had not.

Among the infants whose mothers were vaccinated, there was a 41% reduction in the risk of laboratory-confirmed influenza virus infection compared with those whose mothers declined vaccination.

When the analysis was restricted only to cases of influenza that required hospitalization, a 39% reduction in risk was found for infants of women who had been vaccinated, compared with those of mothers who had not been vaccinated.

Cord blood samples or infant blood samples taken at 2-3 months of age were available for 160 study subjects. In this subgroup, the risk of influenza infection declined with increasing antibody titers.

The exact mechanism by which vaccination of the mother conferred protection to the infant is not certain. It may be due to maternal influenza antibodies being acquired transplacentally or through breastfeeding, or to reduced infant exposure to influenza in the mother. It even could be due to residual confounding not accounted for in the statistical analyses, but the finding of significantly higher antibody titers in 2- to 3-month-old infants who did not develop illness argues against that possibility, Dr. Eick and her colleagues said.

Disclosures: The study was funded by the U.S. Department of Health and Human Services’ National Vaccine Program Office, the Office of Minority and Women’s Health (now the Office of Health Disparities), the Centers for Disease Control and Prevention, Aventis-Pasteur, and Evans-Powderject. One of Dr. Eick’s associates reported ties with MedImmune, Pfizer, and Sanofi-Pasteur, all of which manufacture influenza vaccine.

Vaccinating pregnant women against seasonal influenza reduced the risk of laboratory-confirmed influenza infection in their infants by 41%, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Maternal immunization similarly cut by 39% the risk that infants up to 6 months of age would be hospitalized for influenza-like illness, said Angelia A. Eick, Ph.D., of the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

Influenza vaccination is already recommended for pregnant women to reduce their risk of developing flu-related complications. “These findings provide support for the added benefit of protecting infants from influenza virus infection up to 6 months, the period when infants are not eligible for influenza vaccination but are at highest risk of severe influenza illness,” the investigators noted.

Even though such immunization is recommended during pregnancy, it is not well accepted in the United States and many pregnant women do not get vaccinated. Since it would be unethical to perform a randomized, controlled study of maternal vaccination, Dr. Eick and her colleagues conducted a nonrandomized observational study to assess whether immunization during pregnancy conferred protection to infants.

The study subjects were 1,160 mother-infant pairs in which approximately half the mothers (573) had chosen to receive seasonal flu vaccine while pregnant and the other half (587) had declined the vaccine. All were enrolled after delivering healthy singleton infants at 7 hospitals serving the Navajo and White Mountain Apache Indian reservations in the southwestern United States during three flu seasons between 2002 and 2005.

A total of 605 infants developed influenza-like illness during the flu season following delivery. “We found a 41% reduction in the risk of laboratory-confirmed influenza virus infection for infants of influenza-vaccinated mothers compared with infants of unvaccinated mothers,” the researchers said (Arch Pediatr. Adolesc. Med. 2010 [doi10.1001/archpediatrics.2010.192]).

The incidence of influenza-like illness was 6.7 per 1,000 person-days for infants of mothers who had been vaccinated, compared with 7.2 per 1,000 person-days for infants of mothers who had not.

Among the infants whose mothers were vaccinated, there was a 41% reduction in the risk of laboratory-confirmed influenza virus infection compared with those whose mothers declined vaccination.

When the analysis was restricted only to cases of influenza that required hospitalization, a 39% reduction in risk was found for infants of women who had been vaccinated, compared with those of mothers who had not been vaccinated.

Cord blood samples or infant blood samples taken at 2-3 months of age were available for 160 study subjects. In this subgroup, the risk of influenza infection declined with increasing antibody titers.

The exact mechanism by which vaccination of the mother conferred protection to the infant is not certain. It may be due to maternal influenza antibodies being acquired transplacentally or through breastfeeding, or to reduced infant exposure to influenza in the mother. It even could be due to residual confounding not accounted for in the statistical analyses, but the finding of significantly higher antibody titers in 2- to 3-month-old infants who did not develop illness argues against that possibility, Dr. Eick and her colleagues said.

Disclosures: The study was funded by the U.S. Department of Health and Human Services’ National Vaccine Program Office, the Office of Minority and Women’s Health (now the Office of Health Disparities), the Centers for Disease Control and Prevention, Aventis-Pasteur, and Evans-Powderject. One of Dr. Eick’s associates reported ties with MedImmune, Pfizer, and Sanofi-Pasteur, all of which manufacture influenza vaccine.

Vaccinating pregnant women against seasonal influenza reduced the risk of laboratory-confirmed influenza infection in their infants by 41%, according to a study published online Oct. 4 in the Archives of Pediatric and Adolescent Medicine.

Maternal immunization similarly cut by 39% the risk that infants up to 6 months of age would be hospitalized for influenza-like illness, said Angelia A. Eick, Ph.D., of the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

Influenza vaccination is already recommended for pregnant women to reduce their risk of developing flu-related complications. “These findings provide support for the added benefit of protecting infants from influenza virus infection up to 6 months, the period when infants are not eligible for influenza vaccination but are at highest risk of severe influenza illness,” the investigators noted.

Even though such immunization is recommended during pregnancy, it is not well accepted in the United States and many pregnant women do not get vaccinated. Since it would be unethical to perform a randomized, controlled study of maternal vaccination, Dr. Eick and her colleagues conducted a nonrandomized observational study to assess whether immunization during pregnancy conferred protection to infants.

The study subjects were 1,160 mother-infant pairs in which approximately half the mothers (573) had chosen to receive seasonal flu vaccine while pregnant and the other half (587) had declined the vaccine. All were enrolled after delivering healthy singleton infants at 7 hospitals serving the Navajo and White Mountain Apache Indian reservations in the southwestern United States during three flu seasons between 2002 and 2005.

A total of 605 infants developed influenza-like illness during the flu season following delivery. “We found a 41% reduction in the risk of laboratory-confirmed influenza virus infection for infants of influenza-vaccinated mothers compared with infants of unvaccinated mothers,” the researchers said (Arch Pediatr. Adolesc. Med. 2010 [doi10.1001/archpediatrics.2010.192]).

The incidence of influenza-like illness was 6.7 per 1,000 person-days for infants of mothers who had been vaccinated, compared with 7.2 per 1,000 person-days for infants of mothers who had not.

Among the infants whose mothers were vaccinated, there was a 41% reduction in the risk of laboratory-confirmed influenza virus infection compared with those whose mothers declined vaccination.

When the analysis was restricted only to cases of influenza that required hospitalization, a 39% reduction in risk was found for infants of women who had been vaccinated, compared with those of mothers who had not been vaccinated.

Cord blood samples or infant blood samples taken at 2-3 months of age were available for 160 study subjects. In this subgroup, the risk of influenza infection declined with increasing antibody titers.

The exact mechanism by which vaccination of the mother conferred protection to the infant is not certain. It may be due to maternal influenza antibodies being acquired transplacentally or through breastfeeding, or to reduced infant exposure to influenza in the mother. It even could be due to residual confounding not accounted for in the statistical analyses, but the finding of significantly higher antibody titers in 2- to 3-month-old infants who did not develop illness argues against that possibility, Dr. Eick and her colleagues said.

Disclosures: The study was funded by the U.S. Department of Health and Human Services’ National Vaccine Program Office, the Office of Minority and Women’s Health (now the Office of Health Disparities), the Centers for Disease Control and Prevention, Aventis-Pasteur, and Evans-Powderject. One of Dr. Eick’s associates reported ties with MedImmune, Pfizer, and Sanofi-Pasteur, all of which manufacture influenza vaccine.

The combination of budesonide plus azathioprine achieves and maintains remission of autoimmune hepatitis as well as standard prednisone therapy does, while sparing patients many of the adverse effects of steroids, Dr. Michael P. Manns and his colleagues said in an article appearing in the October issue of Gastroenterology.

The drug combination may well become “a new standard of care for noncirrhotic patients with autoimmune hepatitis,” wrote Dr. Manns of Hannover (Germany) Medical School and his associates in the journal Gastroenterology (Oct. 2010 [doi: 10.1053/j.gastro.2010.06.046]).

They compared the safety and efficacy of the budesonide combination with the standard therapy of prednisone with azathioprine. The researchers described the study as the largest prospective, randomized, multicenter trial published to date for the treatment of autoimmune hepatitis.

In the first phase of the study, 208 patients aged 10-70 years were randomly assigned to receive budesonide (103 subjects) or prednisone (105 subjects) with azathioprine for 6 months. Budesonide was given in 3-mg oral doses three times daily, a regimen that was decreased to twice daily if remission occurred. Prednisone was started at 40 mg/day and tapered to 10 mg/day.

Azathioprine was administered at a dose of 1-2 mg/kg per day, according to the clinician’s judgment. None of the study subjects had any evidence of cirrhosis.

A total of 176 subjects completed this phase. Reasons for withdrawal included lack of efficacy (3 patients taking budesonide and 12 taking prednisone), adverse events (3 patients taking budesonide, 3 taking prednisone), and lack of compliance with the study protocol (4 patients taking budesonide, 2 taking prednisone).

In the second, open-label phase of the study, all 176 subjects received budesonide plus azathioprine for a further 6 months.

The primary end point was complete biochemical remission of autoimmune hepatitis and the absence of steroid-related adverse effects such as moon face, acne, buffalo hump, hirsutism, striae, diabetes, glaucoma, or increased intraocular pressure.

At the conclusion of the first phase of the study, 47% of the budesonide group achieved this end point, compared with only 18% of the prednisone group.

At the conclusion of the second phase, 55% of the study subjects achieved complete biochemical remission.

The incidence of steroid-related adverse effects was significantly lower after 6 months of budesonide therapy than after 6 months of prednisone therapy. After the second phase of the study, when all the subjects were taking budesonide, there was a reduction of approximately 40% in the incidence of common steroid-related adverse effects.

A post hoc analysis of the data from the first phase of the study showed that budesonide was more effective than prednisone regardless of a patient’s sex, body weight, or HLA type status (DR3 or DR4).

“The potential influence of inflammatory activity was investigated by comparing patients showing high or low aminotransferase levels. Significantly higher rates of complete biochemical response were observed in the budesonide treatment arm vs. prednisone in both subpopulations,” Dr. Manns and his colleagues said.

When adult patients were analyzed separately, the rate of complete remission remained significantly higher with budesonide (67%) than with prednisone (41%). This indicates that “the inclusion of children does not [affect] the overall results of this study,” the researchers noted.

Both study medications were well tolerated. Adverse effects included weight gain (6% of patients taking budesonide and 19% of those taking prednisone), headache (12% and 8%, respectively), mood alterations (10% and 8%), muscular weakness (5% and 8%), hypertension (3% and 7%), and insomnia (1% and 5%).

Further studies are needed to clarify the long-term effects of budesonide therapy, particularly with regard to steroid-specific effects such as an adverse impact on bone metabolism, Dr. Manns and his associates said.

This study was supported by Dr. Falk Pharma GmbH. The investigators reported ties to GlaxoSmithKline, Novartis, Abbott Labs, Essex Pharma GmbH, Roche, and Boehringer Ingelheim GmbH.

The combination of budesonide plus azathioprine achieves and maintains remission of autoimmune hepatitis as well as standard prednisone therapy does, while sparing patients many of the adverse effects of steroids, Dr. Michael P. Manns and his colleagues said in an article appearing in the October issue of Gastroenterology.

The drug combination may well become “a new standard of care for noncirrhotic patients with autoimmune hepatitis,” wrote Dr. Manns of Hannover (Germany) Medical School and his associates in the journal Gastroenterology (Oct. 2010 [doi: 10.1053/j.gastro.2010.06.046]).

They compared the safety and efficacy of the budesonide combination with the standard therapy of prednisone with azathioprine. The researchers described the study as the largest prospective, randomized, multicenter trial published to date for the treatment of autoimmune hepatitis.

In the first phase of the study, 208 patients aged 10-70 years were randomly assigned to receive budesonide (103 subjects) or prednisone (105 subjects) with azathioprine for 6 months. Budesonide was given in 3-mg oral doses three times daily, a regimen that was decreased to twice daily if remission occurred. Prednisone was started at 40 mg/day and tapered to 10 mg/day.

Azathioprine was administered at a dose of 1-2 mg/kg per day, according to the clinician’s judgment. None of the study subjects had any evidence of cirrhosis.

A total of 176 subjects completed this phase. Reasons for withdrawal included lack of efficacy (3 patients taking budesonide and 12 taking prednisone), adverse events (3 patients taking budesonide, 3 taking prednisone), and lack of compliance with the study protocol (4 patients taking budesonide, 2 taking prednisone).

In the second, open-label phase of the study, all 176 subjects received budesonide plus azathioprine for a further 6 months.

The primary end point was complete biochemical remission of autoimmune hepatitis and the absence of steroid-related adverse effects such as moon face, acne, buffalo hump, hirsutism, striae, diabetes, glaucoma, or increased intraocular pressure.

At the conclusion of the first phase of the study, 47% of the budesonide group achieved this end point, compared with only 18% of the prednisone group.

At the conclusion of the second phase, 55% of the study subjects achieved complete biochemical remission.

The incidence of steroid-related adverse effects was significantly lower after 6 months of budesonide therapy than after 6 months of prednisone therapy. After the second phase of the study, when all the subjects were taking budesonide, there was a reduction of approximately 40% in the incidence of common steroid-related adverse effects.

A post hoc analysis of the data from the first phase of the study showed that budesonide was more effective than prednisone regardless of a patient’s sex, body weight, or HLA type status (DR3 or DR4).

“The potential influence of inflammatory activity was investigated by comparing patients showing high or low aminotransferase levels. Significantly higher rates of complete biochemical response were observed in the budesonide treatment arm vs. prednisone in both subpopulations,” Dr. Manns and his colleagues said.

When adult patients were analyzed separately, the rate of complete remission remained significantly higher with budesonide (67%) than with prednisone (41%). This indicates that “the inclusion of children does not [affect] the overall results of this study,” the researchers noted.

Both study medications were well tolerated. Adverse effects included weight gain (6% of patients taking budesonide and 19% of those taking prednisone), headache (12% and 8%, respectively), mood alterations (10% and 8%), muscular weakness (5% and 8%), hypertension (3% and 7%), and insomnia (1% and 5%).

Further studies are needed to clarify the long-term effects of budesonide therapy, particularly with regard to steroid-specific effects such as an adverse impact on bone metabolism, Dr. Manns and his associates said.

This study was supported by Dr. Falk Pharma GmbH. The investigators reported ties to GlaxoSmithKline, Novartis, Abbott Labs, Essex Pharma GmbH, Roche, and Boehringer Ingelheim GmbH.

The combination of budesonide plus azathioprine achieves and maintains remission of autoimmune hepatitis as well as standard prednisone therapy does, while sparing patients many of the adverse effects of steroids, Dr. Michael P. Manns and his colleagues said in an article appearing in the October issue of Gastroenterology.

The drug combination may well become “a new standard of care for noncirrhotic patients with autoimmune hepatitis,” wrote Dr. Manns of Hannover (Germany) Medical School and his associates in the journal Gastroenterology (Oct. 2010 [doi: 10.1053/j.gastro.2010.06.046]).

They compared the safety and efficacy of the budesonide combination with the standard therapy of prednisone with azathioprine. The researchers described the study as the largest prospective, randomized, multicenter trial published to date for the treatment of autoimmune hepatitis.

In the first phase of the study, 208 patients aged 10-70 years were randomly assigned to receive budesonide (103 subjects) or prednisone (105 subjects) with azathioprine for 6 months. Budesonide was given in 3-mg oral doses three times daily, a regimen that was decreased to twice daily if remission occurred. Prednisone was started at 40 mg/day and tapered to 10 mg/day.

Azathioprine was administered at a dose of 1-2 mg/kg per day, according to the clinician’s judgment. None of the study subjects had any evidence of cirrhosis.

A total of 176 subjects completed this phase. Reasons for withdrawal included lack of efficacy (3 patients taking budesonide and 12 taking prednisone), adverse events (3 patients taking budesonide, 3 taking prednisone), and lack of compliance with the study protocol (4 patients taking budesonide, 2 taking prednisone).

In the second, open-label phase of the study, all 176 subjects received budesonide plus azathioprine for a further 6 months.

The primary end point was complete biochemical remission of autoimmune hepatitis and the absence of steroid-related adverse effects such as moon face, acne, buffalo hump, hirsutism, striae, diabetes, glaucoma, or increased intraocular pressure.

At the conclusion of the first phase of the study, 47% of the budesonide group achieved this end point, compared with only 18% of the prednisone group.

At the conclusion of the second phase, 55% of the study subjects achieved complete biochemical remission.

The incidence of steroid-related adverse effects was significantly lower after 6 months of budesonide therapy than after 6 months of prednisone therapy. After the second phase of the study, when all the subjects were taking budesonide, there was a reduction of approximately 40% in the incidence of common steroid-related adverse effects.

A post hoc analysis of the data from the first phase of the study showed that budesonide was more effective than prednisone regardless of a patient’s sex, body weight, or HLA type status (DR3 or DR4).

“The potential influence of inflammatory activity was investigated by comparing patients showing high or low aminotransferase levels. Significantly higher rates of complete biochemical response were observed in the budesonide treatment arm vs. prednisone in both subpopulations,” Dr. Manns and his colleagues said.

When adult patients were analyzed separately, the rate of complete remission remained significantly higher with budesonide (67%) than with prednisone (41%). This indicates that “the inclusion of children does not [affect] the overall results of this study,” the researchers noted.

Both study medications were well tolerated. Adverse effects included weight gain (6% of patients taking budesonide and 19% of those taking prednisone), headache (12% and 8%, respectively), mood alterations (10% and 8%), muscular weakness (5% and 8%), hypertension (3% and 7%), and insomnia (1% and 5%).

Further studies are needed to clarify the long-term effects of budesonide therapy, particularly with regard to steroid-specific effects such as an adverse impact on bone metabolism, Dr. Manns and his associates said.

This study was supported by Dr. Falk Pharma GmbH. The investigators reported ties to GlaxoSmithKline, Novartis, Abbott Labs, Essex Pharma GmbH, Roche, and Boehringer Ingelheim GmbH.

The combination of budesonide plus azathioprine achieves and maintains remission of autoimmune hepatitis as well as standard prednisone therapy does, while sparing patients many of the adverse effects of steroids, Dr. Michael P. Manns and his colleagues said in an article appearing in the October issue of Gastroenterology.

The drug combination may well become “a new standard of care for noncirrhotic patients with autoimmune hepatitis,” wrote Dr. Manns of Hannover (Germany) Medical School and his associates in the journal Gastroenterology (Oct. 2010 [doi: 10.1053/j.gastro.2010.06.046]).

They compared the safety and efficacy of the budesonide combination with the standard therapy of prednisone with azathioprine. The researchers described the study as the largest prospective, randomized, multicenter trial published to date for the treatment of autoimmune hepatitis.

In the first phase of the study, 208 patients aged 10-70 years were randomly assigned to receive budesonide (103 subjects) or prednisone (105 subjects) with azathioprine for 6 months. Budesonide was given in 3-mg oral doses three times daily, a regimen that was decreased to twice daily if remission occurred. Prednisone was started at 40 mg/day and tapered to 10 mg/day.

Azathioprine was administered at a dose of 1-2 mg/kg per day, according to the clinician’s judgment. None of the study subjects had any evidence of cirrhosis.

A total of 176 subjects completed this phase. Reasons for withdrawal included lack of efficacy (3 patients taking budesonide and 12 taking prednisone), adverse events (3 patients taking budesonide, 3 taking prednisone), and lack of compliance with the study protocol (4 patients taking budesonide, 2 taking prednisone).

In the second, open-label phase of the study, all 176 subjects received budesonide plus azathioprine for a further 6 months.

The primary end point was complete biochemical remission of autoimmune hepatitis and the absence of steroid-related adverse effects such as moon face, acne, buffalo hump, hirsutism, striae, diabetes, glaucoma, or increased intraocular pressure.

At the conclusion of the first phase of the study, 47% of the budesonide group achieved this end point, compared with only 18% of the prednisone group.

At the conclusion of the second phase, 55% of the study subjects achieved complete biochemical remission.

The incidence of steroid-related adverse effects was significantly lower after 6 months of budesonide therapy than after 6 months of prednisone therapy. After the second phase of the study, when all the subjects were taking budesonide, there was a reduction of approximately 40% in the incidence of common steroid-related adverse effects.

A post hoc analysis of the data from the first phase of the study showed that budesonide was more effective than prednisone regardless of a patient’s sex, body weight, or HLA type status (DR3 or DR4).

“The potential influence of inflammatory activity was investigated by comparing patients showing high or low aminotransferase levels. Significantly higher rates of complete biochemical response were observed in the budesonide treatment arm vs. prednisone in both subpopulations,” Dr. Manns and his colleagues said.

When adult patients were analyzed separately, the rate of complete remission remained significantly higher with budesonide (67%) than with prednisone (41%). This indicates that “the inclusion of children does not [affect] the overall results of this study,” the researchers noted.

Both study medications were well tolerated. Adverse effects included weight gain (6% of patients taking budesonide and 19% of those taking prednisone), headache (12% and 8%, respectively), mood alterations (10% and 8%), muscular weakness (5% and 8%), hypertension (3% and 7%), and insomnia (1% and 5%).

Further studies are needed to clarify the long-term effects of budesonide therapy, particularly with regard to steroid-specific effects such as an adverse impact on bone metabolism, Dr. Manns and his associates said.

This study was supported by Dr. Falk Pharma GmbH. The investigators reported ties to GlaxoSmithKline, Novartis, Abbott Labs, Essex Pharma GmbH, Roche, and Boehringer Ingelheim GmbH.

The combination of budesonide plus azathioprine achieves and maintains remission of autoimmune hepatitis as well as standard prednisone therapy does, while sparing patients many of the adverse effects of steroids, Dr. Michael P. Manns and his colleagues said in an article appearing in the October issue of Gastroenterology.

The drug combination may well become “a new standard of care for noncirrhotic patients with autoimmune hepatitis,” wrote Dr. Manns of Hannover (Germany) Medical School and his associates in the journal Gastroenterology (Oct. 2010 [doi: 10.1053/j.gastro.2010.06.046]).

They compared the safety and efficacy of the budesonide combination with the standard therapy of prednisone with azathioprine. The researchers described the study as the largest prospective, randomized, multicenter trial published to date for the treatment of autoimmune hepatitis.

In the first phase of the study, 208 patients aged 10-70 years were randomly assigned to receive budesonide (103 subjects) or prednisone (105 subjects) with azathioprine for 6 months. Budesonide was given in 3-mg oral doses three times daily, a regimen that was decreased to twice daily if remission occurred. Prednisone was started at 40 mg/day and tapered to 10 mg/day.

Azathioprine was administered at a dose of 1-2 mg/kg per day, according to the clinician’s judgment. None of the study subjects had any evidence of cirrhosis.

A total of 176 subjects completed this phase. Reasons for withdrawal included lack of efficacy (3 patients taking budesonide and 12 taking prednisone), adverse events (3 patients taking budesonide, 3 taking prednisone), and lack of compliance with the study protocol (4 patients taking budesonide, 2 taking prednisone).

In the second, open-label phase of the study, all 176 subjects received budesonide plus azathioprine for a further 6 months.

The primary end point was complete biochemical remission of autoimmune hepatitis and the absence of steroid-related adverse effects such as moon face, acne, buffalo hump, hirsutism, striae, diabetes, glaucoma, or increased intraocular pressure.

At the conclusion of the first phase of the study, 47% of the budesonide group achieved this end point, compared with only 18% of the prednisone group.

At the conclusion of the second phase, 55% of the study subjects achieved complete biochemical remission.

The incidence of steroid-related adverse effects was significantly lower after 6 months of budesonide therapy than after 6 months of prednisone therapy. After the second phase of the study, when all the subjects were taking budesonide, there was a reduction of approximately 40% in the incidence of common steroid-related adverse effects.

A post hoc analysis of the data from the first phase of the study showed that budesonide was more effective than prednisone regardless of a patient’s sex, body weight, or HLA type status (DR3 or DR4).

“The potential influence of inflammatory activity was investigated by comparing patients showing high or low aminotransferase levels. Significantly higher rates of complete biochemical response were observed in the budesonide treatment arm vs. prednisone in both subpopulations,” Dr. Manns and his colleagues said.

When adult patients were analyzed separately, the rate of complete remission remained significantly higher with budesonide (67%) than with prednisone (41%). This indicates that “the inclusion of children does not [affect] the overall results of this study,” the researchers noted.

Both study medications were well tolerated. Adverse effects included weight gain (6% of patients taking budesonide and 19% of those taking prednisone), headache (12% and 8%, respectively), mood alterations (10% and 8%), muscular weakness (5% and 8%), hypertension (3% and 7%), and insomnia (1% and 5%).

Further studies are needed to clarify the long-term effects of budesonide therapy, particularly with regard to steroid-specific effects such as an adverse impact on bone metabolism, Dr. Manns and his associates said.

This study was supported by Dr. Falk Pharma GmbH. The investigators reported ties to GlaxoSmithKline, Novartis, Abbott Labs, Essex Pharma GmbH, Roche, and Boehringer Ingelheim GmbH.

The combination of budesonide plus azathioprine achieves and maintains remission of autoimmune hepatitis as well as standard prednisone therapy does, while sparing patients many of the adverse effects of steroids, Dr. Michael P. Manns and his colleagues said in an article appearing in the October issue of Gastroenterology.

The drug combination may well become “a new standard of care for noncirrhotic patients with autoimmune hepatitis,” wrote Dr. Manns of Hannover (Germany) Medical School and his associates in the journal Gastroenterology (Oct. 2010 [doi: 10.1053/j.gastro.2010.06.046]).

They compared the safety and efficacy of the budesonide combination with the standard therapy of prednisone with azathioprine. The researchers described the study as the largest prospective, randomized, multicenter trial published to date for the treatment of autoimmune hepatitis.

In the first phase of the study, 208 patients aged 10-70 years were randomly assigned to receive budesonide (103 subjects) or prednisone (105 subjects) with azathioprine for 6 months. Budesonide was given in 3-mg oral doses three times daily, a regimen that was decreased to twice daily if remission occurred. Prednisone was started at 40 mg/day and tapered to 10 mg/day.

Azathioprine was administered at a dose of 1-2 mg/kg per day, according to the clinician’s judgment. None of the study subjects had any evidence of cirrhosis.

A total of 176 subjects completed this phase. Reasons for withdrawal included lack of efficacy (3 patients taking budesonide and 12 taking prednisone), adverse events (3 patients taking budesonide, 3 taking prednisone), and lack of compliance with the study protocol (4 patients taking budesonide, 2 taking prednisone).

In the second, open-label phase of the study, all 176 subjects received budesonide plus azathioprine for a further 6 months.

The primary end point was complete biochemical remission of autoimmune hepatitis and the absence of steroid-related adverse effects such as moon face, acne, buffalo hump, hirsutism, striae, diabetes, glaucoma, or increased intraocular pressure.

At the conclusion of the first phase of the study, 47% of the budesonide group achieved this end point, compared with only 18% of the prednisone group.

At the conclusion of the second phase, 55% of the study subjects achieved complete biochemical remission.

The incidence of steroid-related adverse effects was significantly lower after 6 months of budesonide therapy than after 6 months of prednisone therapy. After the second phase of the study, when all the subjects were taking budesonide, there was a reduction of approximately 40% in the incidence of common steroid-related adverse effects.

A post hoc analysis of the data from the first phase of the study showed that budesonide was more effective than prednisone regardless of a patient’s sex, body weight, or HLA type status (DR3 or DR4).

“The potential influence of inflammatory activity was investigated by comparing patients showing high or low aminotransferase levels. Significantly higher rates of complete biochemical response were observed in the budesonide treatment arm vs. prednisone in both subpopulations,” Dr. Manns and his colleagues said.

When adult patients were analyzed separately, the rate of complete remission remained significantly higher with budesonide (67%) than with prednisone (41%). This indicates that “the inclusion of children does not [affect] the overall results of this study,” the researchers noted.

Both study medications were well tolerated. Adverse effects included weight gain (6% of patients taking budesonide and 19% of those taking prednisone), headache (12% and 8%, respectively), mood alterations (10% and 8%), muscular weakness (5% and 8%), hypertension (3% and 7%), and insomnia (1% and 5%).

Further studies are needed to clarify the long-term effects of budesonide therapy, particularly with regard to steroid-specific effects such as an adverse impact on bone metabolism, Dr. Manns and his associates said.

This study was supported by Dr. Falk Pharma GmbH. The investigators reported ties to GlaxoSmithKline, Novartis, Abbott Labs, Essex Pharma GmbH, Roche, and Boehringer Ingelheim GmbH.

The cost of colorectal cancer screening could be cut substantially without impairing its effectiveness by adopting a “resect and discard” approach for the smallest polyps, Dr. Cesare Hassan and his colleagues said in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.05.018).

A major portion of the cost of colorectal cancer screening is attributed to pathologic examination of polyps that are identified and resected. Among patients at average risk, more than 60% of all polyps detected at screening are diminutive (5 mm or smaller) and have an extremely low likelihood of being cancerous, said Dr. Hassan of Nuovo Regina Margherita Hospital, Rome, and his associates.

The “resect and discard” approach calls for simply discarding diminutive lesions rather than performing pathology exams on them. This approach is facilitated by the use of new colonoscopy technology that incorporates narrow-band imaging, which allows for better characterization of the smallest polyps and could conceivably avert further histologic assessment.

The investigators used mathematical modeling to create a cost-effectiveness simulation that would assess the potential savings of adopting a “resect and discard” approach for diminutive polyps in a hypothetical cohort of 100,000 average-risk American men and women aged 50-100 years. The hypothetical costs were calculated by using Medicare reimbursement data.

The model assumed that 85% of colorectal cancers develop from a polypoid precursor, and the remaining 15% are de novo tumors. It incorporated several possible health states: no colorectal neoplasia; diminutive (5 mm or smaller), small (6-9 mm), or large (10 mm or larger) adenomatous polyps; localized, regional, or distant colorectal cancer; and colorectal cancer–related death. Hyperplastic polyps also were included in the simulation.

“In order not to overestimate the efficacy of [narrow-band imaging],” the investigators used performance statistics derived from the literature and assumed an 84% rate of high-confidence classification of polyps, with a 94% sensitivity and an 89% specificity for identifying adenomas.

The model further assumed that a “resect and discard” policy was followed for all cases in which a high-confidence diagnosis was achieved using narrow-band imaging, and that all diminutive polyps in which a high-confidence diagnosis could not be made were removed and sent for formal histologic assessment.

The simulation first tested the cost-effectiveness of standard colonoscopy with pathology evaluations of all resected polyps in the cohort. The procedure was found to reduce colorectal cancer incidence by 75% and mortality by 79%.

When these outcomes were projected onto the U.S. population using 2009 census data and assuming a 23% rate of adherence to screening colonoscopy in the general population, standard colonoscopy screening was found to save $451 million annually, compared with no colonoscopy screening.

The simulation then tested the “resect and discard” approach and found an additional annual benefit of $25 per person screened. When this outcome was projected onto the U.S. population, this approach added an estimated $33 million in cost savings to the standard colonoscopy approach.

Importantly, the “resect and discard” approach showed no meaningful effect on the efficacy of colorectal cancer screening, Dr. Hassan and his colleagues noted.

“In theory, the ‘resect and discard’ strategy could affect the efficacy of colonoscopy screening. On one hand, the imperfect narrow band imaging sensitivity for diminutive adenomas would misclassify some polyps as hyperplastic, preventing the standard follow-up strategy, whilst on the other, the misclassification of hyperplastic polyps as adenomatous lesions caused by the suboptimal specificity would lead to a more intensive and inappropriate 5-year colonoscopy surveillance in some individuals.

“However, the net effect of these two opposing forces was found to be meaningless, mainly because of the marginal efficacy associated with postpolypectomy surveillance, especially for diminutive lesions, compared with the substantial efficacy associated with polypectomy in preventing colorectal cancer,” they explained.

No industry funding supported this study. Dr. Hassan’s colleagues reported ties to Medicsight, Viatronix, and Philips, as well as Olympus.

The cost of colorectal cancer screening could be cut substantially without impairing its effectiveness by adopting a “resect and discard” approach for the smallest polyps, Dr. Cesare Hassan and his colleagues said in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.05.018).

A major portion of the cost of colorectal cancer screening is attributed to pathologic examination of polyps that are identified and resected. Among patients at average risk, more than 60% of all polyps detected at screening are diminutive (5 mm or smaller) and have an extremely low likelihood of being cancerous, said Dr. Hassan of Nuovo Regina Margherita Hospital, Rome, and his associates.

The “resect and discard” approach calls for simply discarding diminutive lesions rather than performing pathology exams on them. This approach is facilitated by the use of new colonoscopy technology that incorporates narrow-band imaging, which allows for better characterization of the smallest polyps and could conceivably avert further histologic assessment.

The investigators used mathematical modeling to create a cost-effectiveness simulation that would assess the potential savings of adopting a “resect and discard” approach for diminutive polyps in a hypothetical cohort of 100,000 average-risk American men and women aged 50-100 years. The hypothetical costs were calculated by using Medicare reimbursement data.

The model assumed that 85% of colorectal cancers develop from a polypoid precursor, and the remaining 15% are de novo tumors. It incorporated several possible health states: no colorectal neoplasia; diminutive (5 mm or smaller), small (6-9 mm), or large (10 mm or larger) adenomatous polyps; localized, regional, or distant colorectal cancer; and colorectal cancer–related death. Hyperplastic polyps also were included in the simulation.

“In order not to overestimate the efficacy of [narrow-band imaging],” the investigators used performance statistics derived from the literature and assumed an 84% rate of high-confidence classification of polyps, with a 94% sensitivity and an 89% specificity for identifying adenomas.

The model further assumed that a “resect and discard” policy was followed for all cases in which a high-confidence diagnosis was achieved using narrow-band imaging, and that all diminutive polyps in which a high-confidence diagnosis could not be made were removed and sent for formal histologic assessment.

The simulation first tested the cost-effectiveness of standard colonoscopy with pathology evaluations of all resected polyps in the cohort. The procedure was found to reduce colorectal cancer incidence by 75% and mortality by 79%.

When these outcomes were projected onto the U.S. population using 2009 census data and assuming a 23% rate of adherence to screening colonoscopy in the general population, standard colonoscopy screening was found to save $451 million annually, compared with no colonoscopy screening.

The simulation then tested the “resect and discard” approach and found an additional annual benefit of $25 per person screened. When this outcome was projected onto the U.S. population, this approach added an estimated $33 million in cost savings to the standard colonoscopy approach.

Importantly, the “resect and discard” approach showed no meaningful effect on the efficacy of colorectal cancer screening, Dr. Hassan and his colleagues noted.

“In theory, the ‘resect and discard’ strategy could affect the efficacy of colonoscopy screening. On one hand, the imperfect narrow band imaging sensitivity for diminutive adenomas would misclassify some polyps as hyperplastic, preventing the standard follow-up strategy, whilst on the other, the misclassification of hyperplastic polyps as adenomatous lesions caused by the suboptimal specificity would lead to a more intensive and inappropriate 5-year colonoscopy surveillance in some individuals.

“However, the net effect of these two opposing forces was found to be meaningless, mainly because of the marginal efficacy associated with postpolypectomy surveillance, especially for diminutive lesions, compared with the substantial efficacy associated with polypectomy in preventing colorectal cancer,” they explained.

No industry funding supported this study. Dr. Hassan’s colleagues reported ties to Medicsight, Viatronix, and Philips, as well as Olympus.

The cost of colorectal cancer screening could be cut substantially without impairing its effectiveness by adopting a “resect and discard” approach for the smallest polyps, Dr. Cesare Hassan and his colleagues said in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.05.018).

A major portion of the cost of colorectal cancer screening is attributed to pathologic examination of polyps that are identified and resected. Among patients at average risk, more than 60% of all polyps detected at screening are diminutive (5 mm or smaller) and have an extremely low likelihood of being cancerous, said Dr. Hassan of Nuovo Regina Margherita Hospital, Rome, and his associates.

The “resect and discard” approach calls for simply discarding diminutive lesions rather than performing pathology exams on them. This approach is facilitated by the use of new colonoscopy technology that incorporates narrow-band imaging, which allows for better characterization of the smallest polyps and could conceivably avert further histologic assessment.

The investigators used mathematical modeling to create a cost-effectiveness simulation that would assess the potential savings of adopting a “resect and discard” approach for diminutive polyps in a hypothetical cohort of 100,000 average-risk American men and women aged 50-100 years. The hypothetical costs were calculated by using Medicare reimbursement data.

The model assumed that 85% of colorectal cancers develop from a polypoid precursor, and the remaining 15% are de novo tumors. It incorporated several possible health states: no colorectal neoplasia; diminutive (5 mm or smaller), small (6-9 mm), or large (10 mm or larger) adenomatous polyps; localized, regional, or distant colorectal cancer; and colorectal cancer–related death. Hyperplastic polyps also were included in the simulation.

“In order not to overestimate the efficacy of [narrow-band imaging],” the investigators used performance statistics derived from the literature and assumed an 84% rate of high-confidence classification of polyps, with a 94% sensitivity and an 89% specificity for identifying adenomas.

The model further assumed that a “resect and discard” policy was followed for all cases in which a high-confidence diagnosis was achieved using narrow-band imaging, and that all diminutive polyps in which a high-confidence diagnosis could not be made were removed and sent for formal histologic assessment.

The simulation first tested the cost-effectiveness of standard colonoscopy with pathology evaluations of all resected polyps in the cohort. The procedure was found to reduce colorectal cancer incidence by 75% and mortality by 79%.

When these outcomes were projected onto the U.S. population using 2009 census data and assuming a 23% rate of adherence to screening colonoscopy in the general population, standard colonoscopy screening was found to save $451 million annually, compared with no colonoscopy screening.

The simulation then tested the “resect and discard” approach and found an additional annual benefit of $25 per person screened. When this outcome was projected onto the U.S. population, this approach added an estimated $33 million in cost savings to the standard colonoscopy approach.

Importantly, the “resect and discard” approach showed no meaningful effect on the efficacy of colorectal cancer screening, Dr. Hassan and his colleagues noted.

“In theory, the ‘resect and discard’ strategy could affect the efficacy of colonoscopy screening. On one hand, the imperfect narrow band imaging sensitivity for diminutive adenomas would misclassify some polyps as hyperplastic, preventing the standard follow-up strategy, whilst on the other, the misclassification of hyperplastic polyps as adenomatous lesions caused by the suboptimal specificity would lead to a more intensive and inappropriate 5-year colonoscopy surveillance in some individuals.

“However, the net effect of these two opposing forces was found to be meaningless, mainly because of the marginal efficacy associated with postpolypectomy surveillance, especially for diminutive lesions, compared with the substantial efficacy associated with polypectomy in preventing colorectal cancer,” they explained.

No industry funding supported this study. Dr. Hassan’s colleagues reported ties to Medicsight, Viatronix, and Philips, as well as Olympus.

The cost of colorectal cancer screening could be cut substantially without impairing its effectiveness by adopting a “resect and discard” approach for the smallest polyps, Dr. Cesare Hassan and his colleagues said in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.05.018).

A major portion of the cost of colorectal cancer screening is attributed to pathologic examination of polyps that are identified and resected. Among patients at average risk, more than 60% of all polyps detected at screening are diminutive (5 mm or smaller) and have an extremely low likelihood of being cancerous, said Dr. Hassan of Nuovo Regina Margherita Hospital, Rome, and his associates.

The “resect and discard” approach calls for simply discarding diminutive lesions rather than performing pathology exams on them. This approach is facilitated by the use of new colonoscopy technology that incorporates narrow-band imaging, which allows for better characterization of the smallest polyps and could conceivably avert further histologic assessment.

The investigators used mathematical modeling to create a cost-effectiveness simulation that would assess the potential savings of adopting a “resect and discard” approach for diminutive polyps in a hypothetical cohort of 100,000 average-risk American men and women aged 50-100 years. The hypothetical costs were calculated by using Medicare reimbursement data.

The model assumed that 85% of colorectal cancers develop from a polypoid precursor, and the remaining 15% are de novo tumors. It incorporated several possible health states: no colorectal neoplasia; diminutive (5 mm or smaller), small (6-9 mm), or large (10 mm or larger) adenomatous polyps; localized, regional, or distant colorectal cancer; and colorectal cancer–related death. Hyperplastic polyps also were included in the simulation.

“In order not to overestimate the efficacy of [narrow-band imaging],” the investigators used performance statistics derived from the literature and assumed an 84% rate of high-confidence classification of polyps, with a 94% sensitivity and an 89% specificity for identifying adenomas.

The model further assumed that a “resect and discard” policy was followed for all cases in which a high-confidence diagnosis was achieved using narrow-band imaging, and that all diminutive polyps in which a high-confidence diagnosis could not be made were removed and sent for formal histologic assessment.

The simulation first tested the cost-effectiveness of standard colonoscopy with pathology evaluations of all resected polyps in the cohort. The procedure was found to reduce colorectal cancer incidence by 75% and mortality by 79%.

When these outcomes were projected onto the U.S. population using 2009 census data and assuming a 23% rate of adherence to screening colonoscopy in the general population, standard colonoscopy screening was found to save $451 million annually, compared with no colonoscopy screening.

The simulation then tested the “resect and discard” approach and found an additional annual benefit of $25 per person screened. When this outcome was projected onto the U.S. population, this approach added an estimated $33 million in cost savings to the standard colonoscopy approach.

Importantly, the “resect and discard” approach showed no meaningful effect on the efficacy of colorectal cancer screening, Dr. Hassan and his colleagues noted.

“In theory, the ‘resect and discard’ strategy could affect the efficacy of colonoscopy screening. On one hand, the imperfect narrow band imaging sensitivity for diminutive adenomas would misclassify some polyps as hyperplastic, preventing the standard follow-up strategy, whilst on the other, the misclassification of hyperplastic polyps as adenomatous lesions caused by the suboptimal specificity would lead to a more intensive and inappropriate 5-year colonoscopy surveillance in some individuals.

“However, the net effect of these two opposing forces was found to be meaningless, mainly because of the marginal efficacy associated with postpolypectomy surveillance, especially for diminutive lesions, compared with the substantial efficacy associated with polypectomy in preventing colorectal cancer,” they explained.

No industry funding supported this study. Dr. Hassan’s colleagues reported ties to Medicsight, Viatronix, and Philips, as well as Olympus.

The cost of colorectal cancer screening could be cut substantially without impairing its effectiveness by adopting a “resect and discard” approach for the smallest polyps, Dr. Cesare Hassan and his colleagues said in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.05.018).

A major portion of the cost of colorectal cancer screening is attributed to pathologic examination of polyps that are identified and resected. Among patients at average risk, more than 60% of all polyps detected at screening are diminutive (5 mm or smaller) and have an extremely low likelihood of being cancerous, said Dr. Hassan of Nuovo Regina Margherita Hospital, Rome, and his associates.

The “resect and discard” approach calls for simply discarding diminutive lesions rather than performing pathology exams on them. This approach is facilitated by the use of new colonoscopy technology that incorporates narrow-band imaging, which allows for better characterization of the smallest polyps and could conceivably avert further histologic assessment.

The investigators used mathematical modeling to create a cost-effectiveness simulation that would assess the potential savings of adopting a “resect and discard” approach for diminutive polyps in a hypothetical cohort of 100,000 average-risk American men and women aged 50-100 years. The hypothetical costs were calculated by using Medicare reimbursement data.

The model assumed that 85% of colorectal cancers develop from a polypoid precursor, and the remaining 15% are de novo tumors. It incorporated several possible health states: no colorectal neoplasia; diminutive (5 mm or smaller), small (6-9 mm), or large (10 mm or larger) adenomatous polyps; localized, regional, or distant colorectal cancer; and colorectal cancer–related death. Hyperplastic polyps also were included in the simulation.

“In order not to overestimate the efficacy of [narrow-band imaging],” the investigators used performance statistics derived from the literature and assumed an 84% rate of high-confidence classification of polyps, with a 94% sensitivity and an 89% specificity for identifying adenomas.

The model further assumed that a “resect and discard” policy was followed for all cases in which a high-confidence diagnosis was achieved using narrow-band imaging, and that all diminutive polyps in which a high-confidence diagnosis could not be made were removed and sent for formal histologic assessment.

The simulation first tested the cost-effectiveness of standard colonoscopy with pathology evaluations of all resected polyps in the cohort. The procedure was found to reduce colorectal cancer incidence by 75% and mortality by 79%.

When these outcomes were projected onto the U.S. population using 2009 census data and assuming a 23% rate of adherence to screening colonoscopy in the general population, standard colonoscopy screening was found to save $451 million annually, compared with no colonoscopy screening.

The simulation then tested the “resect and discard” approach and found an additional annual benefit of $25 per person screened. When this outcome was projected onto the U.S. population, this approach added an estimated $33 million in cost savings to the standard colonoscopy approach.

Importantly, the “resect and discard” approach showed no meaningful effect on the efficacy of colorectal cancer screening, Dr. Hassan and his colleagues noted.

“In theory, the ‘resect and discard’ strategy could affect the efficacy of colonoscopy screening. On one hand, the imperfect narrow band imaging sensitivity for diminutive adenomas would misclassify some polyps as hyperplastic, preventing the standard follow-up strategy, whilst on the other, the misclassification of hyperplastic polyps as adenomatous lesions caused by the suboptimal specificity would lead to a more intensive and inappropriate 5-year colonoscopy surveillance in some individuals.

“However, the net effect of these two opposing forces was found to be meaningless, mainly because of the marginal efficacy associated with postpolypectomy surveillance, especially for diminutive lesions, compared with the substantial efficacy associated with polypectomy in preventing colorectal cancer,” they explained.

No industry funding supported this study. Dr. Hassan’s colleagues reported ties to Medicsight, Viatronix, and Philips, as well as Olympus.

The cost of colorectal cancer screening could be cut substantially without impairing its effectiveness by adopting a “resect and discard” approach for the smallest polyps, Dr. Cesare Hassan and his colleagues said in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.05.018).

A major portion of the cost of colorectal cancer screening is attributed to pathologic examination of polyps that are identified and resected. Among patients at average risk, more than 60% of all polyps detected at screening are diminutive (5 mm or smaller) and have an extremely low likelihood of being cancerous, said Dr. Hassan of Nuovo Regina Margherita Hospital, Rome, and his associates.

The “resect and discard” approach calls for simply discarding diminutive lesions rather than performing pathology exams on them. This approach is facilitated by the use of new colonoscopy technology that incorporates narrow-band imaging, which allows for better characterization of the smallest polyps and could conceivably avert further histologic assessment.

The investigators used mathematical modeling to create a cost-effectiveness simulation that would assess the potential savings of adopting a “resect and discard” approach for diminutive polyps in a hypothetical cohort of 100,000 average-risk American men and women aged 50-100 years. The hypothetical costs were calculated by using Medicare reimbursement data.

The model assumed that 85% of colorectal cancers develop from a polypoid precursor, and the remaining 15% are de novo tumors. It incorporated several possible health states: no colorectal neoplasia; diminutive (5 mm or smaller), small (6-9 mm), or large (10 mm or larger) adenomatous polyps; localized, regional, or distant colorectal cancer; and colorectal cancer–related death. Hyperplastic polyps also were included in the simulation.

“In order not to overestimate the efficacy of [narrow-band imaging],” the investigators used performance statistics derived from the literature and assumed an 84% rate of high-confidence classification of polyps, with a 94% sensitivity and an 89% specificity for identifying adenomas.

The model further assumed that a “resect and discard” policy was followed for all cases in which a high-confidence diagnosis was achieved using narrow-band imaging, and that all diminutive polyps in which a high-confidence diagnosis could not be made were removed and sent for formal histologic assessment.

The simulation first tested the cost-effectiveness of standard colonoscopy with pathology evaluations of all resected polyps in the cohort. The procedure was found to reduce colorectal cancer incidence by 75% and mortality by 79%.

When these outcomes were projected onto the U.S. population using 2009 census data and assuming a 23% rate of adherence to screening colonoscopy in the general population, standard colonoscopy screening was found to save $451 million annually, compared with no colonoscopy screening.

The simulation then tested the “resect and discard” approach and found an additional annual benefit of $25 per person screened. When this outcome was projected onto the U.S. population, this approach added an estimated $33 million in cost savings to the standard colonoscopy approach.

Importantly, the “resect and discard” approach showed no meaningful effect on the efficacy of colorectal cancer screening, Dr. Hassan and his colleagues noted.

“In theory, the ‘resect and discard’ strategy could affect the efficacy of colonoscopy screening. On one hand, the imperfect narrow band imaging sensitivity for diminutive adenomas would misclassify some polyps as hyperplastic, preventing the standard follow-up strategy, whilst on the other, the misclassification of hyperplastic polyps as adenomatous lesions caused by the suboptimal specificity would lead to a more intensive and inappropriate 5-year colonoscopy surveillance in some individuals.

“However, the net effect of these two opposing forces was found to be meaningless, mainly because of the marginal efficacy associated with postpolypectomy surveillance, especially for diminutive lesions, compared with the substantial efficacy associated with polypectomy in preventing colorectal cancer,” they explained.

No industry funding supported this study. Dr. Hassan’s colleagues reported ties to Medicsight, Viatronix, and Philips, as well as Olympus.

The rate of serious adverse events related to liver biopsy is approximately 1% in patients with advanced chronic hepatitis C, which is comparable to the overall rate of biopsy complications, Dr. Leonard B. Seeff and his colleagues reported in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.03.025).

Although the risks of liver biopsy in general are well documented, few studies have specifically examined adverse effects of the procedure in patients with advanced hepatitis C. It was not known until now whether they are at greater risk for complications than are patients with more mild chronic liver disease, said Dr. Seeff of the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md., and his associates.

The investigators assessed these risks using data from the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) study, a large clinical trial evaluating the safety and efficacy of peginterferon alfa-2a and ribavirin. The study protocol mandated that serial liver biopsies be performed at baseline, 1.5 years, and 3.5 years. The trial was conducted at 10 clinical centers during 2000-2006.

Adverse events were defined as serious if they necessitated hospitalization, costly investigations such as ultrasound or CT, or blood transfusion, or if they led to perforation of an organ, surgery, or death.

Approximately 90% of the biopsies were outpatient procedures. In 80% of the procedures, bedside ultrasound guidance was utilized, and all included anesthetizing the subcutaneous tissue and liver capsule. Sixty percent of the procedures involved conscious sedation with short-acting benzodiazepines.

Most of the needles used were 16 gauge. Sixty percent of the biopsies utilized a cutting needle and the other 40% used an aspiration needle. At six of the medical centers, two passes usually were used to obtain adequate, unfragmented samples, whereas a single pass was routine at the remaining four medical centers.

All the medical centers required that a complete blood count, platelet count, and prothrombin time (PT) or international normalized ratio (INR) be performed before biopsy. Six centers allowed biopsies to proceed in patients with low platelet counts, four of them when the platelet count was as low as 50,000/mm3. The other four centers required platelet counts of at least 70,000/mm3 before permitting biopsy.

There were 2,740 biopsies: 1,187 at baseline, 852 at 1.5 years, and 701 at 3.5 years. A total of 63 complications developed, 29 of them serious, for an overall 1.1% rate of serious complications.

Slightly more than half of the serious adverse events (16) were bleeding events: hemoperitoneum (8 patients), subcapsular hematoma (4 patients), hemobilia (3 patients), and hemothorax (1 patient). Four patients required transfusions, and eight underwent embolization of the bleeding vessel and/or surgery to evacuate the blood.

Bleeding events are “the most commonly reported and concerning” major complication, and numerous studies have reported typical rates of 0.8%-1.7% related to liver biopsies. The 1.1% rate in this population of patients with advanced disease falls within that range, Dr. Seeff and his colleagues noted.

Other serious complications included severe pain (seven patients), punctured gall bladder (two patients), and marked hypotension, pneumothorax, syncope, and dehydration in one patient each. There were no deaths related to the biopsy procedure.

Serious complications were significantly related to a platelet count of 60,000/mm3 or lower, an INR of 1.3 or greater, and the presence of any esophageal varices on upper endoscopy.

“If liver biopsies had been avoided when platelet counts were less than or equal to 60,000/mm3, bleeding as a complication would have been reduced by 25% while eliminating only 2.8% of the biopsies,” the researchers said.

The complication rate did not differ significantly across treatment centers and was not significantly associated with patient body mass index, length of the biopsy specimen, fragmentation of the liver tissue, the presence or absence of splenomegaly, the use or nonuse of peginterferon alfa-2a or ribavirin, the type of biopsy needle, the use or nonuse of ultrasound guidance, or the presence of cirrhosis versus bridging fibrosis.

“A trend was observed, however, toward a greater risk of a nonbleeding serious adverse event if more than one pass was made or an inexperienced operator performed the procedure,” they noted.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Additional support was provided by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Center for Minority Health and Health Disparities, the National Center for Research Resources, and Hoffmann-La Roche. Several of Dr. Seeff’s associates also reported financial ties to Hoffmann-La Roche.

The rate of serious adverse events related to liver biopsy is approximately 1% in patients with advanced chronic hepatitis C, which is comparable to the overall rate of biopsy complications, Dr. Leonard B. Seeff and his colleagues reported in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.03.025).

Although the risks of liver biopsy in general are well documented, few studies have specifically examined adverse effects of the procedure in patients with advanced hepatitis C. It was not known until now whether they are at greater risk for complications than are patients with more mild chronic liver disease, said Dr. Seeff of the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md., and his associates.

The investigators assessed these risks using data from the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) study, a large clinical trial evaluating the safety and efficacy of peginterferon alfa-2a and ribavirin. The study protocol mandated that serial liver biopsies be performed at baseline, 1.5 years, and 3.5 years. The trial was conducted at 10 clinical centers during 2000-2006.

Adverse events were defined as serious if they necessitated hospitalization, costly investigations such as ultrasound or CT, or blood transfusion, or if they led to perforation of an organ, surgery, or death.

Approximately 90% of the biopsies were outpatient procedures. In 80% of the procedures, bedside ultrasound guidance was utilized, and all included anesthetizing the subcutaneous tissue and liver capsule. Sixty percent of the procedures involved conscious sedation with short-acting benzodiazepines.

Most of the needles used were 16 gauge. Sixty percent of the biopsies utilized a cutting needle and the other 40% used an aspiration needle. At six of the medical centers, two passes usually were used to obtain adequate, unfragmented samples, whereas a single pass was routine at the remaining four medical centers.

All the medical centers required that a complete blood count, platelet count, and prothrombin time (PT) or international normalized ratio (INR) be performed before biopsy. Six centers allowed biopsies to proceed in patients with low platelet counts, four of them when the platelet count was as low as 50,000/mm3. The other four centers required platelet counts of at least 70,000/mm3 before permitting biopsy.

There were 2,740 biopsies: 1,187 at baseline, 852 at 1.5 years, and 701 at 3.5 years. A total of 63 complications developed, 29 of them serious, for an overall 1.1% rate of serious complications.

Slightly more than half of the serious adverse events (16) were bleeding events: hemoperitoneum (8 patients), subcapsular hematoma (4 patients), hemobilia (3 patients), and hemothorax (1 patient). Four patients required transfusions, and eight underwent embolization of the bleeding vessel and/or surgery to evacuate the blood.

Bleeding events are “the most commonly reported and concerning” major complication, and numerous studies have reported typical rates of 0.8%-1.7% related to liver biopsies. The 1.1% rate in this population of patients with advanced disease falls within that range, Dr. Seeff and his colleagues noted.

Other serious complications included severe pain (seven patients), punctured gall bladder (two patients), and marked hypotension, pneumothorax, syncope, and dehydration in one patient each. There were no deaths related to the biopsy procedure.

Serious complications were significantly related to a platelet count of 60,000/mm3 or lower, an INR of 1.3 or greater, and the presence of any esophageal varices on upper endoscopy.

“If liver biopsies had been avoided when platelet counts were less than or equal to 60,000/mm3, bleeding as a complication would have been reduced by 25% while eliminating only 2.8% of the biopsies,” the researchers said.

The complication rate did not differ significantly across treatment centers and was not significantly associated with patient body mass index, length of the biopsy specimen, fragmentation of the liver tissue, the presence or absence of splenomegaly, the use or nonuse of peginterferon alfa-2a or ribavirin, the type of biopsy needle, the use or nonuse of ultrasound guidance, or the presence of cirrhosis versus bridging fibrosis.

“A trend was observed, however, toward a greater risk of a nonbleeding serious adverse event if more than one pass was made or an inexperienced operator performed the procedure,” they noted.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Additional support was provided by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Center for Minority Health and Health Disparities, the National Center for Research Resources, and Hoffmann-La Roche. Several of Dr. Seeff’s associates also reported financial ties to Hoffmann-La Roche.

The rate of serious adverse events related to liver biopsy is approximately 1% in patients with advanced chronic hepatitis C, which is comparable to the overall rate of biopsy complications, Dr. Leonard B. Seeff and his colleagues reported in an article appearing in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2010.03.025).

Although the risks of liver biopsy in general are well documented, few studies have specifically examined adverse effects of the procedure in patients with advanced hepatitis C. It was not known until now whether they are at greater risk for complications than are patients with more mild chronic liver disease, said Dr. Seeff of the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md., and his associates.

The investigators assessed these risks using data from the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) study, a large clinical trial evaluating the safety and efficacy of peginterferon alfa-2a and ribavirin. The study protocol mandated that serial liver biopsies be performed at baseline, 1.5 years, and 3.5 years. The trial was conducted at 10 clinical centers during 2000-2006.

Adverse events were defined as serious if they necessitated hospitalization, costly investigations such as ultrasound or CT, or blood transfusion, or if they led to perforation of an organ, surgery, or death.

Approximately 90% of the biopsies were outpatient procedures. In 80% of the procedures, bedside ultrasound guidance was utilized, and all included anesthetizing the subcutaneous tissue and liver capsule. Sixty percent of the procedures involved conscious sedation with short-acting benzodiazepines.

Most of the needles used were 16 gauge. Sixty percent of the biopsies utilized a cutting needle and the other 40% used an aspiration needle. At six of the medical centers, two passes usually were used to obtain adequate, unfragmented samples, whereas a single pass was routine at the remaining four medical centers.

All the medical centers required that a complete blood count, platelet count, and prothrombin time (PT) or international normalized ratio (INR) be performed before biopsy. Six centers allowed biopsies to proceed in patients with low platelet counts, four of them when the platelet count was as low as 50,000/mm3. The other four centers required platelet counts of at least 70,000/mm3 before permitting biopsy.

There were 2,740 biopsies: 1,187 at baseline, 852 at 1.5 years, and 701 at 3.5 years. A total of 63 complications developed, 29 of them serious, for an overall 1.1% rate of serious complications.

Slightly more than half of the serious adverse events (16) were bleeding events: hemoperitoneum (8 patients), subcapsular hematoma (4 patients), hemobilia (3 patients), and hemothorax (1 patient). Four patients required transfusions, and eight underwent embolization of the bleeding vessel and/or surgery to evacuate the blood.

Bleeding events are “the most commonly reported and concerning” major complication, and numerous studies have reported typical rates of 0.8%-1.7% related to liver biopsies. The 1.1% rate in this population of patients with advanced disease falls within that range, Dr. Seeff and his colleagues noted.

Other serious complications included severe pain (seven patients), punctured gall bladder (two patients), and marked hypotension, pneumothorax, syncope, and dehydration in one patient each. There were no deaths related to the biopsy procedure.

Serious complications were significantly related to a platelet count of 60,000/mm3 or lower, an INR of 1.3 or greater, and the presence of any esophageal varices on upper endoscopy.

“If liver biopsies had been avoided when platelet counts were less than or equal to 60,000/mm3, bleeding as a complication would have been reduced by 25% while eliminating only 2.8% of the biopsies,” the researchers said.

The complication rate did not differ significantly across treatment centers and was not significantly associated with patient body mass index, length of the biopsy specimen, fragmentation of the liver tissue, the presence or absence of splenomegaly, the use or nonuse of peginterferon alfa-2a or ribavirin, the type of biopsy needle, the use or nonuse of ultrasound guidance, or the presence of cirrhosis versus bridging fibrosis.

“A trend was observed, however, toward a greater risk of a nonbleeding serious adverse event if more than one pass was made or an inexperienced operator performed the procedure,” they noted.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Additional support was provided by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Center for Minority Health and Health Disparities, the National Center for Research Resources, and Hoffmann-La Roche. Several of Dr. Seeff’s associates also reported financial ties to Hoffmann-La Roche.