Sharon Worcester

Major Finding: Average ADMA levels were 0.9 micromol/L in 40 recently diagnosed diabetic patients who were free of diabetes-related complications and medications. The value was significantly higher than the 0.7-micromol/L average level seen in 40 healthy controls

Data Source: A case-control study of patients with early type 2 diabetes and healthy controls matched for age, sex, and body mass index.

Disclosures: The investigators noted that they had no relevant disclosures.

Asymmetric dimethylarginine, or ADMA, is independently associated with diabetes, and may play a role in the development of insulin resistance, according to a study by Iranian researchers.

ADMA levels in the study were significantly higher in 40 recently diagnosed diabetic patients who were free of diabetes medications and diabetes-related complications (0.9 micromol/L), compared with 40 healthy controls matched with the patients for age, sex, and body mass index (0.7 micromol/L), reported Dr. Manouchehr Nakhjavani and colleagues at Tehran (Iran) University of Medical Sciences.

The investigators set out to evaluate the association between ADMA, a potent endogenous nitric oxide (NO) synthase inhibitor; high-sensitivity C-reactive protein (hs-CRP), a marker of chronic inflammation; and insulin resistance in patients with earlystage type 2 diabetes. Like ADMA, hs-CRP was significantly higher in the diabetes patients (3.0 mg/L) than in the controls (1.3 mg/L). Age- and sex-adjusted ADMA values were significantly correlated with the hs-CRP levels; a similar finding was reported in an earlier study, which suggested that a “complex interrelation … could exist between ADMA and chronic inflammation in the prediabetic and diabetic state,” they noted (Ann. Endocrinol. 2010 April 30 [doi:10.1016/j.ando.2010.02.026]).

The adjusted ADMA levels in the current study also were significantly correlated with homeostasis model assessment of insulin resistance (HOMA-IR) in patients, but not in controls; the association with HOMA-IR in patients remained significant after the researchers controlled for body mass index, waist circumference, serum lipids, and hs-CRP, they reported.

The finding of an association between ADMA and insulin resistance independent of hs-CRP, body adiposity, and lipid profile, “possibly shows that high ADMA in early diabetes can lead to NO depletion or ineffectiveness of NO-mediated vasodilator mechanisms associated with the progression of insulin resistance to type 2 diabetes,” the investigators wrote.

Additional studies to investigate this possibility, as well as to evaluate the association between ADMA and HOMA-IR in healthy individuals, are needed, the researchers concluded, noting that the lack of a finding of such an association in the current study conflicts with some prior studies.

Major Finding: Average ADMA levels were 0.9 micromol/L in 40 recently diagnosed diabetic patients who were free of diabetes-related complications and medications. The value was significantly higher than the 0.7-micromol/L average level seen in 40 healthy controls

Data Source: A case-control study of patients with early type 2 diabetes and healthy controls matched for age, sex, and body mass index.

Disclosures: The investigators noted that they had no relevant disclosures.

Asymmetric dimethylarginine, or ADMA, is independently associated with diabetes, and may play a role in the development of insulin resistance, according to a study by Iranian researchers.

ADMA levels in the study were significantly higher in 40 recently diagnosed diabetic patients who were free of diabetes medications and diabetes-related complications (0.9 micromol/L), compared with 40 healthy controls matched with the patients for age, sex, and body mass index (0.7 micromol/L), reported Dr. Manouchehr Nakhjavani and colleagues at Tehran (Iran) University of Medical Sciences.

The investigators set out to evaluate the association between ADMA, a potent endogenous nitric oxide (NO) synthase inhibitor; high-sensitivity C-reactive protein (hs-CRP), a marker of chronic inflammation; and insulin resistance in patients with earlystage type 2 diabetes. Like ADMA, hs-CRP was significantly higher in the diabetes patients (3.0 mg/L) than in the controls (1.3 mg/L). Age- and sex-adjusted ADMA values were significantly correlated with the hs-CRP levels; a similar finding was reported in an earlier study, which suggested that a “complex interrelation … could exist between ADMA and chronic inflammation in the prediabetic and diabetic state,” they noted (Ann. Endocrinol. 2010 April 30 [doi:10.1016/j.ando.2010.02.026]).

The adjusted ADMA levels in the current study also were significantly correlated with homeostasis model assessment of insulin resistance (HOMA-IR) in patients, but not in controls; the association with HOMA-IR in patients remained significant after the researchers controlled for body mass index, waist circumference, serum lipids, and hs-CRP, they reported.

The finding of an association between ADMA and insulin resistance independent of hs-CRP, body adiposity, and lipid profile, “possibly shows that high ADMA in early diabetes can lead to NO depletion or ineffectiveness of NO-mediated vasodilator mechanisms associated with the progression of insulin resistance to type 2 diabetes,” the investigators wrote.

Additional studies to investigate this possibility, as well as to evaluate the association between ADMA and HOMA-IR in healthy individuals, are needed, the researchers concluded, noting that the lack of a finding of such an association in the current study conflicts with some prior studies.

Major Finding: Average ADMA levels were 0.9 micromol/L in 40 recently diagnosed diabetic patients who were free of diabetes-related complications and medications. The value was significantly higher than the 0.7-micromol/L average level seen in 40 healthy controls

Data Source: A case-control study of patients with early type 2 diabetes and healthy controls matched for age, sex, and body mass index.

Disclosures: The investigators noted that they had no relevant disclosures.

Asymmetric dimethylarginine, or ADMA, is independently associated with diabetes, and may play a role in the development of insulin resistance, according to a study by Iranian researchers.

ADMA levels in the study were significantly higher in 40 recently diagnosed diabetic patients who were free of diabetes medications and diabetes-related complications (0.9 micromol/L), compared with 40 healthy controls matched with the patients for age, sex, and body mass index (0.7 micromol/L), reported Dr. Manouchehr Nakhjavani and colleagues at Tehran (Iran) University of Medical Sciences.

The investigators set out to evaluate the association between ADMA, a potent endogenous nitric oxide (NO) synthase inhibitor; high-sensitivity C-reactive protein (hs-CRP), a marker of chronic inflammation; and insulin resistance in patients with earlystage type 2 diabetes. Like ADMA, hs-CRP was significantly higher in the diabetes patients (3.0 mg/L) than in the controls (1.3 mg/L). Age- and sex-adjusted ADMA values were significantly correlated with the hs-CRP levels; a similar finding was reported in an earlier study, which suggested that a “complex interrelation … could exist between ADMA and chronic inflammation in the prediabetic and diabetic state,” they noted (Ann. Endocrinol. 2010 April 30 [doi:10.1016/j.ando.2010.02.026]).

The adjusted ADMA levels in the current study also were significantly correlated with homeostasis model assessment of insulin resistance (HOMA-IR) in patients, but not in controls; the association with HOMA-IR in patients remained significant after the researchers controlled for body mass index, waist circumference, serum lipids, and hs-CRP, they reported.

The finding of an association between ADMA and insulin resistance independent of hs-CRP, body adiposity, and lipid profile, “possibly shows that high ADMA in early diabetes can lead to NO depletion or ineffectiveness of NO-mediated vasodilator mechanisms associated with the progression of insulin resistance to type 2 diabetes,” the investigators wrote.

Additional studies to investigate this possibility, as well as to evaluate the association between ADMA and HOMA-IR in healthy individuals, are needed, the researchers concluded, noting that the lack of a finding of such an association in the current study conflicts with some prior studies.

Routine laboratory monitoring of children with juvenile idiopathic arthritis who take nonsteroidal anti-inflammatory medications has limited clinical utility and most likely is not cost effective, a medical records review suggests.

The records of 91 children who were diagnosed with JIA, treated with an NSAID for at least 1 month, and followed in a pediatric rheumatology clinic between January 1996 and September 2006 were reviewed for the results of laboratory monitoring of hemoglobin, transaminases, blood urea nitrogen, serum creatinine, and urinalysis, as well as for clinically significant NSAID-related effects.

Laboratory abnormalities were recorded for 24 of the 91 patients included in the study, but nearly all were mild and were not associated with clinical sequelae, said Dr. Sheetal S. Vora of the Medical College of Wisconsin, Milwaukee.

Of the 62 patients with oligoarticular disease, abnormalities included low hemoglobin in 5, elevated serum transaminases in 7, elevated BUN in 9, and trace proteinuria in 1. Five had abnormalities in two categories, and one of these patients discontinued NSAIDs.

Of the 29 patients with polyarticular disease, abnormalities included low hemoglobin in 5, elevated BUN in 1, and trace proteinuria in 1; none of these patients had more than one abnormality recorded, and none discontinued NSAID treatment, the investigators found (Pediatr. Rheumatol. 2010;8:11).

The frequency of testing varied widely in the patients studied, with frequency ranging from 0 to 17 times per patient for serum AST, and from 0 to 14 times per patient for serum ALT, for example.

The median frequency of most tests was 1 or 2, except urinalysis, which had a median frequency of 0 tests per patient. The median duration of NSAID treatment was 12 months, and all patients were treated with only one NSAID at a time (most often naproxen). Few patients received any additional medications, the investigators noted.

Although many physicians perform routine laboratory monitoring in children with JIA who are treated with NSAIDS, there are no consensus evidence-based guidelines regarding this practice.

Based on the findings of this study, it appears that such monitoring is unwarranted, they said.

“Our study suggests that clinically significant adverse events requiring the cessation of NSAIDs and detected by routine laboratory monitoring appear to be very infrequent. A prospective study to determine the incidence and prevalence of significant NSAID-related adverse effects detected by routine serial laboratory monitoring in children with JIA would be helpful for better defining the value of routine laboratory testing.

Disclosures: The authors declared that they had no conflicts of interest.

Routine laboratory monitoring of children with juvenile idiopathic arthritis who take nonsteroidal anti-inflammatory medications has limited clinical utility and most likely is not cost effective, a medical records review suggests.

The records of 91 children who were diagnosed with JIA, treated with an NSAID for at least 1 month, and followed in a pediatric rheumatology clinic between January 1996 and September 2006 were reviewed for the results of laboratory monitoring of hemoglobin, transaminases, blood urea nitrogen, serum creatinine, and urinalysis, as well as for clinically significant NSAID-related effects.

Laboratory abnormalities were recorded for 24 of the 91 patients included in the study, but nearly all were mild and were not associated with clinical sequelae, said Dr. Sheetal S. Vora of the Medical College of Wisconsin, Milwaukee.

Of the 62 patients with oligoarticular disease, abnormalities included low hemoglobin in 5, elevated serum transaminases in 7, elevated BUN in 9, and trace proteinuria in 1. Five had abnormalities in two categories, and one of these patients discontinued NSAIDs.

Of the 29 patients with polyarticular disease, abnormalities included low hemoglobin in 5, elevated BUN in 1, and trace proteinuria in 1; none of these patients had more than one abnormality recorded, and none discontinued NSAID treatment, the investigators found (Pediatr. Rheumatol. 2010;8:11).

The frequency of testing varied widely in the patients studied, with frequency ranging from 0 to 17 times per patient for serum AST, and from 0 to 14 times per patient for serum ALT, for example.

The median frequency of most tests was 1 or 2, except urinalysis, which had a median frequency of 0 tests per patient. The median duration of NSAID treatment was 12 months, and all patients were treated with only one NSAID at a time (most often naproxen). Few patients received any additional medications, the investigators noted.

Although many physicians perform routine laboratory monitoring in children with JIA who are treated with NSAIDS, there are no consensus evidence-based guidelines regarding this practice.

Based on the findings of this study, it appears that such monitoring is unwarranted, they said.

“Our study suggests that clinically significant adverse events requiring the cessation of NSAIDs and detected by routine laboratory monitoring appear to be very infrequent. A prospective study to determine the incidence and prevalence of significant NSAID-related adverse effects detected by routine serial laboratory monitoring in children with JIA would be helpful for better defining the value of routine laboratory testing.

Disclosures: The authors declared that they had no conflicts of interest.

Routine laboratory monitoring of children with juvenile idiopathic arthritis who take nonsteroidal anti-inflammatory medications has limited clinical utility and most likely is not cost effective, a medical records review suggests.

The records of 91 children who were diagnosed with JIA, treated with an NSAID for at least 1 month, and followed in a pediatric rheumatology clinic between January 1996 and September 2006 were reviewed for the results of laboratory monitoring of hemoglobin, transaminases, blood urea nitrogen, serum creatinine, and urinalysis, as well as for clinically significant NSAID-related effects.

Laboratory abnormalities were recorded for 24 of the 91 patients included in the study, but nearly all were mild and were not associated with clinical sequelae, said Dr. Sheetal S. Vora of the Medical College of Wisconsin, Milwaukee.

Of the 62 patients with oligoarticular disease, abnormalities included low hemoglobin in 5, elevated serum transaminases in 7, elevated BUN in 9, and trace proteinuria in 1. Five had abnormalities in two categories, and one of these patients discontinued NSAIDs.

Of the 29 patients with polyarticular disease, abnormalities included low hemoglobin in 5, elevated BUN in 1, and trace proteinuria in 1; none of these patients had more than one abnormality recorded, and none discontinued NSAID treatment, the investigators found (Pediatr. Rheumatol. 2010;8:11).

The frequency of testing varied widely in the patients studied, with frequency ranging from 0 to 17 times per patient for serum AST, and from 0 to 14 times per patient for serum ALT, for example.

The median frequency of most tests was 1 or 2, except urinalysis, which had a median frequency of 0 tests per patient. The median duration of NSAID treatment was 12 months, and all patients were treated with only one NSAID at a time (most often naproxen). Few patients received any additional medications, the investigators noted.

Although many physicians perform routine laboratory monitoring in children with JIA who are treated with NSAIDS, there are no consensus evidence-based guidelines regarding this practice.

Based on the findings of this study, it appears that such monitoring is unwarranted, they said.

“Our study suggests that clinically significant adverse events requiring the cessation of NSAIDs and detected by routine laboratory monitoring appear to be very infrequent. A prospective study to determine the incidence and prevalence of significant NSAID-related adverse effects detected by routine serial laboratory monitoring in children with JIA would be helpful for better defining the value of routine laboratory testing.

Disclosures: The authors declared that they had no conflicts of interest.

Major Finding: Ten-year survival in gender-matched heart transplantation was 69%–71%, compared with 58%–59% in mismatched cases.

Data Source: A review of 857 heart transplant patients from between 1994 and 2008.

Disclosures: Dr. Kittleson reported that she had no relevant disclosures with regard to this presentation.

CHICAGO — Gender mismatch between heart donors and transplant recipients who were on triple-drug immunosuppression without induction therapy was associated with significantly lower 10-year survival, according to results of a study of 857 heart transplant cases.

The findings suggest that gender mismatch portends a poor prognosis in heart transplantation, Dr. Michelle Kittleson said at the meeting.

“The implications … are that maintaining sex matching in heart transplantation is beneficial, and these findings may impact donor selection and recipient wait time to transplant,” she said.

Previous studies showing decreased survival in gender mismatch heart transplant cases did not distinguish between immunosuppressive regimens or the use of induction therapy. So the current study was designed to evaluate the impact of gender mismatch in patients on standard triple-drug immunosuppression without induction therapy (tacrolimus, mycophenolate mofetil, and prednisone), explained Dr. Kittleson of the University of California, Los Angeles.

Dr. Kittleson and her colleagues assessed patients for 10-year actuarial survival and for freedom from allograft vasculopathy and nonfatal major adverse cardiac events, such as mycardial infarction, heart failure, percutaneous intervention, defibrillation, stroke, and new peripheral vascular disease.

Differences in survival between the gender-matched and gender-mismatched groups were statistically significant, but no significant differences were seen on the other outcome measures.

The investigators evaluated cases between 1994 and 2008 that included 506 with male-to-male (MM) donation, 132 with female-to-male (FM) donation, 113 with female-to-female (FF) donation, and 106 with male-to-female (MF) donation.

Ten-year survival rates in the four groups, respectively, were 69%, 58%, 71%, and 59%, Dr. Kittleson said.

Previous studies, such as one in which researchers used United Network for Organ Sharing data, have shown similar survival results with gender-mismatched transplantation with FM donation; most have suggested that female recipients are not affected by donor gender (Circ. Heart Failure 2009;2:401–8).

Although the mechanisms for this are unclear, several explanations have been suggested, such as immunologic effects and smaller heart size in FM donation, which provides inadequate functional reserve for males.

In the current study, however, both male and female recipient survival was affected by mismatched donor gender, which might be a factor of study design and follow-up, Dr. Kittleson noted.

For example, survival in FM donation decreased rapidly and remained lower throughout the 10-year period, compared with gender-matched donations, while survival in MF donation did not begin to diverge until after the 4th posttransplant year; some prior studies failed to extend follow-up long enough to identify this divergence.

Another study showing no survival differences in females enrolled patients over a longer time period, which could explain the difference.

Major Finding: Ten-year survival in gender-matched heart transplantation was 69%–71%, compared with 58%–59% in mismatched cases.

Data Source: A review of 857 heart transplant patients from between 1994 and 2008.

Disclosures: Dr. Kittleson reported that she had no relevant disclosures with regard to this presentation.

CHICAGO — Gender mismatch between heart donors and transplant recipients who were on triple-drug immunosuppression without induction therapy was associated with significantly lower 10-year survival, according to results of a study of 857 heart transplant cases.

The findings suggest that gender mismatch portends a poor prognosis in heart transplantation, Dr. Michelle Kittleson said at the meeting.

“The implications … are that maintaining sex matching in heart transplantation is beneficial, and these findings may impact donor selection and recipient wait time to transplant,” she said.

Previous studies showing decreased survival in gender mismatch heart transplant cases did not distinguish between immunosuppressive regimens or the use of induction therapy. So the current study was designed to evaluate the impact of gender mismatch in patients on standard triple-drug immunosuppression without induction therapy (tacrolimus, mycophenolate mofetil, and prednisone), explained Dr. Kittleson of the University of California, Los Angeles.

Dr. Kittleson and her colleagues assessed patients for 10-year actuarial survival and for freedom from allograft vasculopathy and nonfatal major adverse cardiac events, such as mycardial infarction, heart failure, percutaneous intervention, defibrillation, stroke, and new peripheral vascular disease.

Differences in survival between the gender-matched and gender-mismatched groups were statistically significant, but no significant differences were seen on the other outcome measures.

The investigators evaluated cases between 1994 and 2008 that included 506 with male-to-male (MM) donation, 132 with female-to-male (FM) donation, 113 with female-to-female (FF) donation, and 106 with male-to-female (MF) donation.

Ten-year survival rates in the four groups, respectively, were 69%, 58%, 71%, and 59%, Dr. Kittleson said.

Previous studies, such as one in which researchers used United Network for Organ Sharing data, have shown similar survival results with gender-mismatched transplantation with FM donation; most have suggested that female recipients are not affected by donor gender (Circ. Heart Failure 2009;2:401–8).

Although the mechanisms for this are unclear, several explanations have been suggested, such as immunologic effects and smaller heart size in FM donation, which provides inadequate functional reserve for males.

In the current study, however, both male and female recipient survival was affected by mismatched donor gender, which might be a factor of study design and follow-up, Dr. Kittleson noted.

For example, survival in FM donation decreased rapidly and remained lower throughout the 10-year period, compared with gender-matched donations, while survival in MF donation did not begin to diverge until after the 4th posttransplant year; some prior studies failed to extend follow-up long enough to identify this divergence.

Another study showing no survival differences in females enrolled patients over a longer time period, which could explain the difference.

Major Finding: Ten-year survival in gender-matched heart transplantation was 69%–71%, compared with 58%–59% in mismatched cases.

Data Source: A review of 857 heart transplant patients from between 1994 and 2008.

Disclosures: Dr. Kittleson reported that she had no relevant disclosures with regard to this presentation.

CHICAGO — Gender mismatch between heart donors and transplant recipients who were on triple-drug immunosuppression without induction therapy was associated with significantly lower 10-year survival, according to results of a study of 857 heart transplant cases.

The findings suggest that gender mismatch portends a poor prognosis in heart transplantation, Dr. Michelle Kittleson said at the meeting.

“The implications … are that maintaining sex matching in heart transplantation is beneficial, and these findings may impact donor selection and recipient wait time to transplant,” she said.

Previous studies showing decreased survival in gender mismatch heart transplant cases did not distinguish between immunosuppressive regimens or the use of induction therapy. So the current study was designed to evaluate the impact of gender mismatch in patients on standard triple-drug immunosuppression without induction therapy (tacrolimus, mycophenolate mofetil, and prednisone), explained Dr. Kittleson of the University of California, Los Angeles.

Dr. Kittleson and her colleagues assessed patients for 10-year actuarial survival and for freedom from allograft vasculopathy and nonfatal major adverse cardiac events, such as mycardial infarction, heart failure, percutaneous intervention, defibrillation, stroke, and new peripheral vascular disease.

Differences in survival between the gender-matched and gender-mismatched groups were statistically significant, but no significant differences were seen on the other outcome measures.

The investigators evaluated cases between 1994 and 2008 that included 506 with male-to-male (MM) donation, 132 with female-to-male (FM) donation, 113 with female-to-female (FF) donation, and 106 with male-to-female (MF) donation.

Ten-year survival rates in the four groups, respectively, were 69%, 58%, 71%, and 59%, Dr. Kittleson said.

Previous studies, such as one in which researchers used United Network for Organ Sharing data, have shown similar survival results with gender-mismatched transplantation with FM donation; most have suggested that female recipients are not affected by donor gender (Circ. Heart Failure 2009;2:401–8).

Although the mechanisms for this are unclear, several explanations have been suggested, such as immunologic effects and smaller heart size in FM donation, which provides inadequate functional reserve for males.

In the current study, however, both male and female recipient survival was affected by mismatched donor gender, which might be a factor of study design and follow-up, Dr. Kittleson noted.

For example, survival in FM donation decreased rapidly and remained lower throughout the 10-year period, compared with gender-matched donations, while survival in MF donation did not begin to diverge until after the 4th posttransplant year; some prior studies failed to extend follow-up long enough to identify this divergence.

Another study showing no survival differences in females enrolled patients over a longer time period, which could explain the difference.

CHICAGO — Steroid minimization in patients undergoing heart transplantation may be associated with improved survival among patients with existing diabetes as well as a lower incidence of posttransplant, new-onset diabetes, according to research findings reported at the meeting.

In one retrospective study, survival was significantly lower in diabetic vs. nondiabetic transplant patients (about 65% vs. about 80%, respectively) when steroid immunosuppression was not minimized, but survival was similar (about 80% for diabetic vs. 85% for nondiabetic patients) in patients who did have steroid minimization, Dr. Jeffrey J. Teuteberg reported.

The first group included 200 patients who had transplants between 1998 and 2003 and received tacrolimus, mycophenolate, and gradual prednisone taper for immunosuppression. The second group consisted of 217 patients who underwent transplants between 2004 and 2008 and received tacrolimus, mycophenolate, and steroid minimization via rapid taper or alemtuzumab induction therapy, said Dr. Teuteberg of the Cardiovascular Institute at the University of Pittsburgh.

Steroid-free status at 3 years also was improved by steroid minimization. For example, almost all group 2 patients were steroid free at 3 years, compared with 75% of group 1 patients. Rejection rates were similar in both groups.

Differences between patient groups included older age, racial differences, less sensitization, and less ventricular assist device usage among the diabetic patients in group 2 vs. group 1.

“Clearly, there are multiple factors [influencing] why our patients with diabetes are doing better now” he said. A multivariate model is being developed to evaluate how strong a predictor diabetes is by era, and the investigators plan to examine more closely how comorbidities such as renal insufficiency and peripheral vascular disease affect outcomes.

In another study from the University of Pittsburgh, the use of alemtuzumab induction followed by steroid-free maintenance immunosuppression in nondiabetic patients was associated with a lower incidence of new diabetes in the first 3 years after transplant, Raquel Jones reported.

That study included 110 heart transplant recipients who received alemtuzumab induction and 110 historical controls who received no induction therapy. The treatment and control groups had similar baseline characteristics, including body mass index, noted Ms. Jones, a medical student at the University of Pittsburgh.

Donor characteristics also were similar, except the treatment-group donors were significantly older (36 vs. 32 years) with longer ischemic times (209 vs. 171 minutes).

The treatment-group patients received alemtuzumab induction after October 2006, when the center began using such induction routinely. There were 110 control patients treated during October 2001–October 2006 without induction. Both groups received tacrolimus and mycophenolate for chronic immunosuppression, but the treatment group received dose-reduced tacrolimus and no steroids.

Steroid use in the control group at 6 months, 12 months, 2 years, and 3 years was 93%, 56%, 18%, and 0%, respectively, vs. 0% at all time points in the alemtuzumab induction group, Ms. Jones noted.

The baseline incidence of diabetes—defined as the use of any diabetic treatment—was 32% and 29% in the treatment and control groups, respectively. Fewer cases of new diabetes post transplant, relative to baseline, occurred in treatment group vs. the controls (8% vs. 44% of cases at 6 months; 8% vs. 29% of cases at 12 months; 7% vs. 22% of cases at 2 years; and 8% vs. 21% of cases at 3 years). New-onset cases in the noninduction group trended downward in tandem with steroid weaning.

No differences were seen between the two groups with regard to control and management of diabetes, including insulin use, at 3-year follow-up, Ms. Jones said.

Other data from this cohort reported at the meeting showed that alemtuzumab induction and steroid-free immunosuppression are associated with good survival and good rejection-free survival. Together, the findings contribute to the expanding evidence of the value of alemtuzumab induction with steroid-free maintenance in heart transplant patients. Previous studies have demonstrated its merit in other types of transplant, including renal and lung transplant.

Dr. Teuteberg and Ms. Jones discussed off-label use of alemtuzumab, but had no other relevant disclosures.

CHICAGO — Steroid minimization in patients undergoing heart transplantation may be associated with improved survival among patients with existing diabetes as well as a lower incidence of posttransplant, new-onset diabetes, according to research findings reported at the meeting.

In one retrospective study, survival was significantly lower in diabetic vs. nondiabetic transplant patients (about 65% vs. about 80%, respectively) when steroid immunosuppression was not minimized, but survival was similar (about 80% for diabetic vs. 85% for nondiabetic patients) in patients who did have steroid minimization, Dr. Jeffrey J. Teuteberg reported.

The first group included 200 patients who had transplants between 1998 and 2003 and received tacrolimus, mycophenolate, and gradual prednisone taper for immunosuppression. The second group consisted of 217 patients who underwent transplants between 2004 and 2008 and received tacrolimus, mycophenolate, and steroid minimization via rapid taper or alemtuzumab induction therapy, said Dr. Teuteberg of the Cardiovascular Institute at the University of Pittsburgh.

Steroid-free status at 3 years also was improved by steroid minimization. For example, almost all group 2 patients were steroid free at 3 years, compared with 75% of group 1 patients. Rejection rates were similar in both groups.

Differences between patient groups included older age, racial differences, less sensitization, and less ventricular assist device usage among the diabetic patients in group 2 vs. group 1.

“Clearly, there are multiple factors [influencing] why our patients with diabetes are doing better now” he said. A multivariate model is being developed to evaluate how strong a predictor diabetes is by era, and the investigators plan to examine more closely how comorbidities such as renal insufficiency and peripheral vascular disease affect outcomes.

In another study from the University of Pittsburgh, the use of alemtuzumab induction followed by steroid-free maintenance immunosuppression in nondiabetic patients was associated with a lower incidence of new diabetes in the first 3 years after transplant, Raquel Jones reported.

That study included 110 heart transplant recipients who received alemtuzumab induction and 110 historical controls who received no induction therapy. The treatment and control groups had similar baseline characteristics, including body mass index, noted Ms. Jones, a medical student at the University of Pittsburgh.

Donor characteristics also were similar, except the treatment-group donors were significantly older (36 vs. 32 years) with longer ischemic times (209 vs. 171 minutes).

The treatment-group patients received alemtuzumab induction after October 2006, when the center began using such induction routinely. There were 110 control patients treated during October 2001–October 2006 without induction. Both groups received tacrolimus and mycophenolate for chronic immunosuppression, but the treatment group received dose-reduced tacrolimus and no steroids.

Steroid use in the control group at 6 months, 12 months, 2 years, and 3 years was 93%, 56%, 18%, and 0%, respectively, vs. 0% at all time points in the alemtuzumab induction group, Ms. Jones noted.

The baseline incidence of diabetes—defined as the use of any diabetic treatment—was 32% and 29% in the treatment and control groups, respectively. Fewer cases of new diabetes post transplant, relative to baseline, occurred in treatment group vs. the controls (8% vs. 44% of cases at 6 months; 8% vs. 29% of cases at 12 months; 7% vs. 22% of cases at 2 years; and 8% vs. 21% of cases at 3 years). New-onset cases in the noninduction group trended downward in tandem with steroid weaning.

No differences were seen between the two groups with regard to control and management of diabetes, including insulin use, at 3-year follow-up, Ms. Jones said.

Other data from this cohort reported at the meeting showed that alemtuzumab induction and steroid-free immunosuppression are associated with good survival and good rejection-free survival. Together, the findings contribute to the expanding evidence of the value of alemtuzumab induction with steroid-free maintenance in heart transplant patients. Previous studies have demonstrated its merit in other types of transplant, including renal and lung transplant.

Dr. Teuteberg and Ms. Jones discussed off-label use of alemtuzumab, but had no other relevant disclosures.

CHICAGO — Steroid minimization in patients undergoing heart transplantation may be associated with improved survival among patients with existing diabetes as well as a lower incidence of posttransplant, new-onset diabetes, according to research findings reported at the meeting.

In one retrospective study, survival was significantly lower in diabetic vs. nondiabetic transplant patients (about 65% vs. about 80%, respectively) when steroid immunosuppression was not minimized, but survival was similar (about 80% for diabetic vs. 85% for nondiabetic patients) in patients who did have steroid minimization, Dr. Jeffrey J. Teuteberg reported.

The first group included 200 patients who had transplants between 1998 and 2003 and received tacrolimus, mycophenolate, and gradual prednisone taper for immunosuppression. The second group consisted of 217 patients who underwent transplants between 2004 and 2008 and received tacrolimus, mycophenolate, and steroid minimization via rapid taper or alemtuzumab induction therapy, said Dr. Teuteberg of the Cardiovascular Institute at the University of Pittsburgh.

Steroid-free status at 3 years also was improved by steroid minimization. For example, almost all group 2 patients were steroid free at 3 years, compared with 75% of group 1 patients. Rejection rates were similar in both groups.

Differences between patient groups included older age, racial differences, less sensitization, and less ventricular assist device usage among the diabetic patients in group 2 vs. group 1.

“Clearly, there are multiple factors [influencing] why our patients with diabetes are doing better now” he said. A multivariate model is being developed to evaluate how strong a predictor diabetes is by era, and the investigators plan to examine more closely how comorbidities such as renal insufficiency and peripheral vascular disease affect outcomes.

In another study from the University of Pittsburgh, the use of alemtuzumab induction followed by steroid-free maintenance immunosuppression in nondiabetic patients was associated with a lower incidence of new diabetes in the first 3 years after transplant, Raquel Jones reported.

That study included 110 heart transplant recipients who received alemtuzumab induction and 110 historical controls who received no induction therapy. The treatment and control groups had similar baseline characteristics, including body mass index, noted Ms. Jones, a medical student at the University of Pittsburgh.

Donor characteristics also were similar, except the treatment-group donors were significantly older (36 vs. 32 years) with longer ischemic times (209 vs. 171 minutes).

The treatment-group patients received alemtuzumab induction after October 2006, when the center began using such induction routinely. There were 110 control patients treated during October 2001–October 2006 without induction. Both groups received tacrolimus and mycophenolate for chronic immunosuppression, but the treatment group received dose-reduced tacrolimus and no steroids.

Steroid use in the control group at 6 months, 12 months, 2 years, and 3 years was 93%, 56%, 18%, and 0%, respectively, vs. 0% at all time points in the alemtuzumab induction group, Ms. Jones noted.

The baseline incidence of diabetes—defined as the use of any diabetic treatment—was 32% and 29% in the treatment and control groups, respectively. Fewer cases of new diabetes post transplant, relative to baseline, occurred in treatment group vs. the controls (8% vs. 44% of cases at 6 months; 8% vs. 29% of cases at 12 months; 7% vs. 22% of cases at 2 years; and 8% vs. 21% of cases at 3 years). New-onset cases in the noninduction group trended downward in tandem with steroid weaning.

No differences were seen between the two groups with regard to control and management of diabetes, including insulin use, at 3-year follow-up, Ms. Jones said.

Other data from this cohort reported at the meeting showed that alemtuzumab induction and steroid-free immunosuppression are associated with good survival and good rejection-free survival. Together, the findings contribute to the expanding evidence of the value of alemtuzumab induction with steroid-free maintenance in heart transplant patients. Previous studies have demonstrated its merit in other types of transplant, including renal and lung transplant.

Dr. Teuteberg and Ms. Jones discussed off-label use of alemtuzumab, but had no other relevant disclosures.

MIAMI — Obstetricians may be lacking adequate information on the proper management of pregnancies affected by epidermolysis bullosa, findings from a survey suggested.

Of 195 Australian obstetricians who responded to the survey, 111 (57%) said information on epidermolysis bullosa (EB) is needed in prenatal clinics, Dr. Lizbeth Intong reported at the annual meeting of the American Academy of Dermatology.

Of the 195 (7%) respondents, 14 had encountered a pregnancy affected by EB; only 6 (43%) of the 14 said they conducted a literature search for information on the disease to help in their patient management, and only 4 (29%) comanaged their EB patients with a dermatologist, said Dr. Intong, a dermatologist at St. George Hospital in Sydney.

Mothers who had given birth to babies with EB, and mothers with EB who had given birth were also surveyed as part of the study. A total of 58 mothers who had babies with EB responded, and they had 130 babies, including 67 (52%) born with EB. Most babies were born by normal vaginal delivery, with a 5:1 ratio of normal vaginal deliveries to cesarean sections; the more severe the EB type, the more blistering was seen at birth.

Forty-one mothers with EB also responded to the survey. These mothers gave birth to 104 babies, including 50 (48%) born with EB, mostly by normal vaginal delivery. In this group there was a 4:1 ratio of normal vaginal deliveries to C-sections. Two of the mothers with EB reported that their condition worsened during pregnancy, and two said it improved; EB-related problems that were reported included blistering at the site of the adhesive tape used during an epidural and nipple blistering during breastfeeding, which led to a switch from breastfeeding to bottle feeding.

Based on the survey results, Dr. Intong saidshermal vaginal delivery (no forceps or vacuum assistance) is generally safe, that C-section should be considered in severe cases to reduce birth trauma, that nonadhesive tapes and dressings should be used on mothers with EB, and that mothers with EB should get counseling about proper care during breastfeeding, such as the use of nipple shields to help prevent blistering.

Disclosures: None was reported.

MIAMI — Obstetricians may be lacking adequate information on the proper management of pregnancies affected by epidermolysis bullosa, findings from a survey suggested.

Of 195 Australian obstetricians who responded to the survey, 111 (57%) said information on epidermolysis bullosa (EB) is needed in prenatal clinics, Dr. Lizbeth Intong reported at the annual meeting of the American Academy of Dermatology.

Of the 195 (7%) respondents, 14 had encountered a pregnancy affected by EB; only 6 (43%) of the 14 said they conducted a literature search for information on the disease to help in their patient management, and only 4 (29%) comanaged their EB patients with a dermatologist, said Dr. Intong, a dermatologist at St. George Hospital in Sydney.

Mothers who had given birth to babies with EB, and mothers with EB who had given birth were also surveyed as part of the study. A total of 58 mothers who had babies with EB responded, and they had 130 babies, including 67 (52%) born with EB. Most babies were born by normal vaginal delivery, with a 5:1 ratio of normal vaginal deliveries to cesarean sections; the more severe the EB type, the more blistering was seen at birth.

Forty-one mothers with EB also responded to the survey. These mothers gave birth to 104 babies, including 50 (48%) born with EB, mostly by normal vaginal delivery. In this group there was a 4:1 ratio of normal vaginal deliveries to C-sections. Two of the mothers with EB reported that their condition worsened during pregnancy, and two said it improved; EB-related problems that were reported included blistering at the site of the adhesive tape used during an epidural and nipple blistering during breastfeeding, which led to a switch from breastfeeding to bottle feeding.

Based on the survey results, Dr. Intong saidshermal vaginal delivery (no forceps or vacuum assistance) is generally safe, that C-section should be considered in severe cases to reduce birth trauma, that nonadhesive tapes and dressings should be used on mothers with EB, and that mothers with EB should get counseling about proper care during breastfeeding, such as the use of nipple shields to help prevent blistering.

Disclosures: None was reported.

MIAMI — Obstetricians may be lacking adequate information on the proper management of pregnancies affected by epidermolysis bullosa, findings from a survey suggested.

Of 195 Australian obstetricians who responded to the survey, 111 (57%) said information on epidermolysis bullosa (EB) is needed in prenatal clinics, Dr. Lizbeth Intong reported at the annual meeting of the American Academy of Dermatology.

Of the 195 (7%) respondents, 14 had encountered a pregnancy affected by EB; only 6 (43%) of the 14 said they conducted a literature search for information on the disease to help in their patient management, and only 4 (29%) comanaged their EB patients with a dermatologist, said Dr. Intong, a dermatologist at St. George Hospital in Sydney.

Mothers who had given birth to babies with EB, and mothers with EB who had given birth were also surveyed as part of the study. A total of 58 mothers who had babies with EB responded, and they had 130 babies, including 67 (52%) born with EB. Most babies were born by normal vaginal delivery, with a 5:1 ratio of normal vaginal deliveries to cesarean sections; the more severe the EB type, the more blistering was seen at birth.

Forty-one mothers with EB also responded to the survey. These mothers gave birth to 104 babies, including 50 (48%) born with EB, mostly by normal vaginal delivery. In this group there was a 4:1 ratio of normal vaginal deliveries to C-sections. Two of the mothers with EB reported that their condition worsened during pregnancy, and two said it improved; EB-related problems that were reported included blistering at the site of the adhesive tape used during an epidural and nipple blistering during breastfeeding, which led to a switch from breastfeeding to bottle feeding.

Based on the survey results, Dr. Intong saidshermal vaginal delivery (no forceps or vacuum assistance) is generally safe, that C-section should be considered in severe cases to reduce birth trauma, that nonadhesive tapes and dressings should be used on mothers with EB, and that mothers with EB should get counseling about proper care during breastfeeding, such as the use of nipple shields to help prevent blistering.

Disclosures: None was reported.

Major Finding: Women with EC on hand were no less likely to become pregnant than those who had “standard access.” Odds ratios for becoming pregnant ranged from 0.48 to 0.98 for studies with follow-up of 3-12 months.

Data Source: A meta-analysis of 11 randomized controlled trials involving 7,695 women from the United States, China, India, and Sweden.

Disclosures: Two of the Cochrane Review authors were also investigators involved in studies that were included in the review. Ibis Reproductive Health provided support for this study.

Advance provision of emergency contraception is associated with earlier use and increased overall use of EC following unprotected sex, but it does not reduce pregnancy rates, according to the findings of an updated Cochrane Review.

Eleven randomized controlled trials involving 7,695 women from the United States, China, India, and Sweden were included in the new review, which is an updated version of a review completed in 2007 with similar findings.

Women in the 11 trials who had emergency contraception (EC) on hand were no less likely to become pregnant than those who had “standard access,” such as counseling and/or access on request, lead researcher Chelsea Polis of Johns Hopkins University, Baltimore, and her colleagues reported online in the Cochrane Database for Systematic Reviews. Odds ratios ranged from 0.48 to 0.98 for studies with follow-up ranging from 3 months to 12 months, respectively.

Compared with those who had standard access, the women with advance access did use EC more often (odds ratio, 2.47 for single use, 4.13 for multiple use); and they used it earlier (weighted mean average of 12.98 hours earlier). They also were no more likely to contract a sexually transmitted infection (OR, 1.01).

Condom use was the same among those with and without advance access, the investigators found (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD005497

Providing EC in advance of need is a common strategy for ensuring that women have access to EC when they need it, but despite earlier optimistic projections of the potential public health impact of improved access, the findings of this review suggest this approach does not reduce unintended pregnancy, Ms. Polis and her associates reported.

Part of the problem is that some women do not use EC even when it is available. Nonuse varied widely across the studies included in the review, and research suggests that several factors contribute to the decision to not use EC, including unperceived pregnancy risk, concerns about side effects, and inconvenience, the investigators noted.

Nonetheless, the findings should not preclude women from being provided with advance access to EC, particularly since obtaining EC when needed can be difficult and time consuming, and because the review suggests that advance access does not negatively impact sexual and reproductive health behaviors and outcomes, they said.

“Women should be given information about and easy access to emergency contraception because individual women can decrease their chances of pregnancy by using this method,” Ms. Polis and her associates wrote. Future research should focus on the reasons behind failure to use EC when needed and available.

Emergency contraception methods included in this review were combined estrogen-progestin, levonorgestrel alone, and mifepristone.

Major Finding: Women with EC on hand were no less likely to become pregnant than those who had “standard access.” Odds ratios for becoming pregnant ranged from 0.48 to 0.98 for studies with follow-up of 3-12 months.

Data Source: A meta-analysis of 11 randomized controlled trials involving 7,695 women from the United States, China, India, and Sweden.

Disclosures: Two of the Cochrane Review authors were also investigators involved in studies that were included in the review. Ibis Reproductive Health provided support for this study.

Advance provision of emergency contraception is associated with earlier use and increased overall use of EC following unprotected sex, but it does not reduce pregnancy rates, according to the findings of an updated Cochrane Review.

Eleven randomized controlled trials involving 7,695 women from the United States, China, India, and Sweden were included in the new review, which is an updated version of a review completed in 2007 with similar findings.

Women in the 11 trials who had emergency contraception (EC) on hand were no less likely to become pregnant than those who had “standard access,” such as counseling and/or access on request, lead researcher Chelsea Polis of Johns Hopkins University, Baltimore, and her colleagues reported online in the Cochrane Database for Systematic Reviews. Odds ratios ranged from 0.48 to 0.98 for studies with follow-up ranging from 3 months to 12 months, respectively.

Compared with those who had standard access, the women with advance access did use EC more often (odds ratio, 2.47 for single use, 4.13 for multiple use); and they used it earlier (weighted mean average of 12.98 hours earlier). They also were no more likely to contract a sexually transmitted infection (OR, 1.01).

Condom use was the same among those with and without advance access, the investigators found (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD005497

Providing EC in advance of need is a common strategy for ensuring that women have access to EC when they need it, but despite earlier optimistic projections of the potential public health impact of improved access, the findings of this review suggest this approach does not reduce unintended pregnancy, Ms. Polis and her associates reported.

Part of the problem is that some women do not use EC even when it is available. Nonuse varied widely across the studies included in the review, and research suggests that several factors contribute to the decision to not use EC, including unperceived pregnancy risk, concerns about side effects, and inconvenience, the investigators noted.

Nonetheless, the findings should not preclude women from being provided with advance access to EC, particularly since obtaining EC when needed can be difficult and time consuming, and because the review suggests that advance access does not negatively impact sexual and reproductive health behaviors and outcomes, they said.

“Women should be given information about and easy access to emergency contraception because individual women can decrease their chances of pregnancy by using this method,” Ms. Polis and her associates wrote. Future research should focus on the reasons behind failure to use EC when needed and available.

Emergency contraception methods included in this review were combined estrogen-progestin, levonorgestrel alone, and mifepristone.

Major Finding: Women with EC on hand were no less likely to become pregnant than those who had “standard access.” Odds ratios for becoming pregnant ranged from 0.48 to 0.98 for studies with follow-up of 3-12 months.

Data Source: A meta-analysis of 11 randomized controlled trials involving 7,695 women from the United States, China, India, and Sweden.

Disclosures: Two of the Cochrane Review authors were also investigators involved in studies that were included in the review. Ibis Reproductive Health provided support for this study.

Advance provision of emergency contraception is associated with earlier use and increased overall use of EC following unprotected sex, but it does not reduce pregnancy rates, according to the findings of an updated Cochrane Review.

Eleven randomized controlled trials involving 7,695 women from the United States, China, India, and Sweden were included in the new review, which is an updated version of a review completed in 2007 with similar findings.

Women in the 11 trials who had emergency contraception (EC) on hand were no less likely to become pregnant than those who had “standard access,” such as counseling and/or access on request, lead researcher Chelsea Polis of Johns Hopkins University, Baltimore, and her colleagues reported online in the Cochrane Database for Systematic Reviews. Odds ratios ranged from 0.48 to 0.98 for studies with follow-up ranging from 3 months to 12 months, respectively.

Compared with those who had standard access, the women with advance access did use EC more often (odds ratio, 2.47 for single use, 4.13 for multiple use); and they used it earlier (weighted mean average of 12.98 hours earlier). They also were no more likely to contract a sexually transmitted infection (OR, 1.01).

Condom use was the same among those with and without advance access, the investigators found (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD005497

Providing EC in advance of need is a common strategy for ensuring that women have access to EC when they need it, but despite earlier optimistic projections of the potential public health impact of improved access, the findings of this review suggest this approach does not reduce unintended pregnancy, Ms. Polis and her associates reported.

Part of the problem is that some women do not use EC even when it is available. Nonuse varied widely across the studies included in the review, and research suggests that several factors contribute to the decision to not use EC, including unperceived pregnancy risk, concerns about side effects, and inconvenience, the investigators noted.

Nonetheless, the findings should not preclude women from being provided with advance access to EC, particularly since obtaining EC when needed can be difficult and time consuming, and because the review suggests that advance access does not negatively impact sexual and reproductive health behaviors and outcomes, they said.

“Women should be given information about and easy access to emergency contraception because individual women can decrease their chances of pregnancy by using this method,” Ms. Polis and her associates wrote. Future research should focus on the reasons behind failure to use EC when needed and available.

Emergency contraception methods included in this review were combined estrogen-progestin, levonorgestrel alone, and mifepristone.

Fewer minorities have arthritis but they feel its impact far more acutely in terms of pain severity and limitations on function, compared with whites, according to National Health Interview Survey data.

The greater impact of arthritis on minorities may result from their having more physically demanding jobs, limited access to health care, increased willingness to report pain and limitations, unwillingness to use medication, and higher rates of obesity, among other plausible explanations, according to Julie Bolen, Ph.D., of the Centers for Disease Control and Prevention and her associates in their report in the journal Preventing Chronic Disease.

The investigators examined combined data from the 2002, 2003, and 2006 National Health Interview Surveys for the study. Taken together, these annual, CDC-conducted surveys include nationally representative data based on interviews with nearly 86,000 individuals from across the United States.

The 2004 and 2005 surveys were excluded from this study because they did not assess arthritis-attributable work limitation and joint pain, the investigators noted (Prev. Chronic Dis. 2010;7:1–5).

The annualized prevalence of arthritis based on the survey data was 24% for whites, 19% for blacks, 11% for Hispanics, 25% for American Indians/Alaska Natives, 8% for Asians and Pacific Islanders, and 21% for multiracial and “other” respondents.

Overall, 38% of those reporting doctor-diagnosed arthritis also reported activity limitations, 31% of those aged 18-64 years reported work limitations, and 26% reported severe joint pain in the prior month.

Blacks, Hispanics, and multiracial/other individuals were disproportionately affected in regard to limitations and pain: Compared with whites, and after adjusting for age, sex, and body mass index, blacks and Hispanics were about 1.3 times as likely to have activity limitations, 1.6-1.7 times as likely to have work limitations, and 1.8-1.9 times as likely to have severe joint pain.

Multiracial/other individuals were 1.7 times as likely to report activity limitations, 2.2 times as likely to report work limitations, and 1.9 times as likely to report severe joint pain, the investigators found.

No significant differences were noted between whites and American Indians/Alaska Natives, or between whites and Asians and Pacific Islanders on these measures, but the sample sizes for these groups were small and therefore statistical power for detecting differences was limited.

The findings show that although the prevalence of arthritis is lower in blacks and Hispanics, the impact of the disease is worse in these populations, compared with whites, the investigators said.

Although the reasons for the racial and ethnic differences demonstrated by the survey data remain unclear, the development of effective and culturally sensitive interventions tailored to the needs of specific populations are needed and could be aided by the findings, they concluded.

“We must address these stark differences in arthritis impact by using what we know,” Jennifer M. Hootman, Ph.D., an epidemiologist for the CDC National Center for Chronic Disease Prevention and Health Promotion and a coauthor on the study, said in a press statement.

“We can educate those with arthritis about increasing physical activity and self-management and reducing obesity, especially those in groups bearing a disproportionate burden from arthritis,” she added.

The investigators noted that additional study would be useful for examining whether health care access, language barriers, differences in the prevalence of risk factors, and/or cultural differences in understanding the survey questions played a role in the disproportionate effects of arthritis seen in this study.

Efforts to increase the reach of evidence-based public health interventions for improving pain and functional limitations are also needed, they said.

“Future efforts to increase reach should use appropriately tailored interventions such as the Spanish-language health communication campaign Buenos Dias Artritis,” they noted.

Fewer minorities have arthritis but they feel its impact far more acutely in terms of pain severity and limitations on function, compared with whites, according to National Health Interview Survey data.

The greater impact of arthritis on minorities may result from their having more physically demanding jobs, limited access to health care, increased willingness to report pain and limitations, unwillingness to use medication, and higher rates of obesity, among other plausible explanations, according to Julie Bolen, Ph.D., of the Centers for Disease Control and Prevention and her associates in their report in the journal Preventing Chronic Disease.

The investigators examined combined data from the 2002, 2003, and 2006 National Health Interview Surveys for the study. Taken together, these annual, CDC-conducted surveys include nationally representative data based on interviews with nearly 86,000 individuals from across the United States.

The 2004 and 2005 surveys were excluded from this study because they did not assess arthritis-attributable work limitation and joint pain, the investigators noted (Prev. Chronic Dis. 2010;7:1–5).

The annualized prevalence of arthritis based on the survey data was 24% for whites, 19% for blacks, 11% for Hispanics, 25% for American Indians/Alaska Natives, 8% for Asians and Pacific Islanders, and 21% for multiracial and “other” respondents.

Overall, 38% of those reporting doctor-diagnosed arthritis also reported activity limitations, 31% of those aged 18-64 years reported work limitations, and 26% reported severe joint pain in the prior month.

Blacks, Hispanics, and multiracial/other individuals were disproportionately affected in regard to limitations and pain: Compared with whites, and after adjusting for age, sex, and body mass index, blacks and Hispanics were about 1.3 times as likely to have activity limitations, 1.6-1.7 times as likely to have work limitations, and 1.8-1.9 times as likely to have severe joint pain.

Multiracial/other individuals were 1.7 times as likely to report activity limitations, 2.2 times as likely to report work limitations, and 1.9 times as likely to report severe joint pain, the investigators found.

No significant differences were noted between whites and American Indians/Alaska Natives, or between whites and Asians and Pacific Islanders on these measures, but the sample sizes for these groups were small and therefore statistical power for detecting differences was limited.

The findings show that although the prevalence of arthritis is lower in blacks and Hispanics, the impact of the disease is worse in these populations, compared with whites, the investigators said.

Although the reasons for the racial and ethnic differences demonstrated by the survey data remain unclear, the development of effective and culturally sensitive interventions tailored to the needs of specific populations are needed and could be aided by the findings, they concluded.

“We must address these stark differences in arthritis impact by using what we know,” Jennifer M. Hootman, Ph.D., an epidemiologist for the CDC National Center for Chronic Disease Prevention and Health Promotion and a coauthor on the study, said in a press statement.

“We can educate those with arthritis about increasing physical activity and self-management and reducing obesity, especially those in groups bearing a disproportionate burden from arthritis,” she added.

The investigators noted that additional study would be useful for examining whether health care access, language barriers, differences in the prevalence of risk factors, and/or cultural differences in understanding the survey questions played a role in the disproportionate effects of arthritis seen in this study.

Efforts to increase the reach of evidence-based public health interventions for improving pain and functional limitations are also needed, they said.

“Future efforts to increase reach should use appropriately tailored interventions such as the Spanish-language health communication campaign Buenos Dias Artritis,” they noted.

Fewer minorities have arthritis but they feel its impact far more acutely in terms of pain severity and limitations on function, compared with whites, according to National Health Interview Survey data.

The greater impact of arthritis on minorities may result from their having more physically demanding jobs, limited access to health care, increased willingness to report pain and limitations, unwillingness to use medication, and higher rates of obesity, among other plausible explanations, according to Julie Bolen, Ph.D., of the Centers for Disease Control and Prevention and her associates in their report in the journal Preventing Chronic Disease.

The investigators examined combined data from the 2002, 2003, and 2006 National Health Interview Surveys for the study. Taken together, these annual, CDC-conducted surveys include nationally representative data based on interviews with nearly 86,000 individuals from across the United States.

The 2004 and 2005 surveys were excluded from this study because they did not assess arthritis-attributable work limitation and joint pain, the investigators noted (Prev. Chronic Dis. 2010;7:1–5).

The annualized prevalence of arthritis based on the survey data was 24% for whites, 19% for blacks, 11% for Hispanics, 25% for American Indians/Alaska Natives, 8% for Asians and Pacific Islanders, and 21% for multiracial and “other” respondents.

Overall, 38% of those reporting doctor-diagnosed arthritis also reported activity limitations, 31% of those aged 18-64 years reported work limitations, and 26% reported severe joint pain in the prior month.

Blacks, Hispanics, and multiracial/other individuals were disproportionately affected in regard to limitations and pain: Compared with whites, and after adjusting for age, sex, and body mass index, blacks and Hispanics were about 1.3 times as likely to have activity limitations, 1.6-1.7 times as likely to have work limitations, and 1.8-1.9 times as likely to have severe joint pain.

Multiracial/other individuals were 1.7 times as likely to report activity limitations, 2.2 times as likely to report work limitations, and 1.9 times as likely to report severe joint pain, the investigators found.

No significant differences were noted between whites and American Indians/Alaska Natives, or between whites and Asians and Pacific Islanders on these measures, but the sample sizes for these groups were small and therefore statistical power for detecting differences was limited.

The findings show that although the prevalence of arthritis is lower in blacks and Hispanics, the impact of the disease is worse in these populations, compared with whites, the investigators said.

Although the reasons for the racial and ethnic differences demonstrated by the survey data remain unclear, the development of effective and culturally sensitive interventions tailored to the needs of specific populations are needed and could be aided by the findings, they concluded.

“We must address these stark differences in arthritis impact by using what we know,” Jennifer M. Hootman, Ph.D., an epidemiologist for the CDC National Center for Chronic Disease Prevention and Health Promotion and a coauthor on the study, said in a press statement.

“We can educate those with arthritis about increasing physical activity and self-management and reducing obesity, especially those in groups bearing a disproportionate burden from arthritis,” she added.

The investigators noted that additional study would be useful for examining whether health care access, language barriers, differences in the prevalence of risk factors, and/or cultural differences in understanding the survey questions played a role in the disproportionate effects of arthritis seen in this study.

Efforts to increase the reach of evidence-based public health interventions for improving pain and functional limitations are also needed, they said.

“Future efforts to increase reach should use appropriately tailored interventions such as the Spanish-language health communication campaign Buenos Dias Artritis,” they noted.

Major Finding: None of 97 analyzed case reports or series reports of drug-induced liver injury included all 42 elements, which the investigators deemed necessary for evaluating causality of such events. A median of 48% of the elements were missing in the reports.

Data Source: Retrospective analysis.

Disclosures: Funding for the Drug-Induced Liver Injury Network is provided by the National Institute of Diabetes and Digestive and Kidney Diseases; the study was conducted on behalf of this network. One author, Dr. John G. McHutchison, reported receiving research support from, and acting as a scientific adviser for, GlaxoSmithKline and Merck & Co.

Key clinical information is often lacking in published reports of drug-induced liver injury, Dr. Vijay K. Agarwal and his colleagues reported.

The finding is concerning, because accurate reporting of drug-induced liver injury—the single leading cause of acute liver failure in the United States—is essential for the development of reliable, interpretable data to help promote early detection and awareness of drug-induced hepatotoxicity, said Dr. Agarwal of Duke University, Durham, N.C., and colleagues.

For the study, which was conducted on behalf of the Drug-Induced Liver Injury Network, the investigators developed a list of 42 elements necessary for evaluating causality of drug-induced liver injury, and they analyzed 97 published case reports or series of such injuries for the presence of these elements.

Basic disease, drug, and demographic information was present in the vast majority of reports, but numerous important elements for determining causality and eliminating alternative causes of liver injury were lacking. These elements included bilirubin level (missing in 12% of reports), initial alkaline phosphatase level (missing in 58% of reports), and competing viral etiologies (missing in more than 50% of reports).

None of the reports included all 42 elements, which the investigators considered to be minimally necessary for evaluating the causes of the adverse effects. A median of 48% of the elements were missing in the reports.

The reports evaluated included 23 single case reports, 7 brief communications, 46 small case series, and 21 letters to the editor, and they focused on six drugs from three drug classes: amoxicillin/clavulanic acid (35 reports), troglitazone (32), rosiglitazone (10), pioglitazone (8), zafirlukast (8), and montelukast (4). The first two drugs are known to cause clinically apparent drug-induced liver disease, while the other four rarely cause liver injury, but case reports have been important in documenting the medications' potential for hepatotoxicity, the investigators noted.

Some studies included only vague descriptions of how certain diagnoses were excluded, and data on abnormal results from serial liver tests often were not included. Single case reports had significantly fewer missing elements than letters to the editor and small case series (a median of 33% vs. 50% and 48% of the elements were missing, respectively).

No significant differences were observed on the basis of journal type: The median percentage of missing elements was 50% for major internal medicine journals, 48% for gastroenterology and liver subspecialty journals, and 45% for other types of journals.

The authors noted that unless the essential details for interpreting the findings are included in such reports, it will be impossible to determine if episodes of hepatotoxicity can be causally assigned to a specific drug or combination of drugs. In addition, opportunities to identify rare events that might not be apparent in clinical trials, and to increase awareness of issues possibly associated with a drug early in its development and use, will be missed, the investigators said. They argued that a more standardized approach to the reporting of drug-induced liver injury is needed.

A checklist of minimal elements for diagnosing drug-related liver injury and for assessing causality should be developed, and a secondary list of elements that are helpful in many situations—such as results of assays for anti–hepatitis E virus antibodies to exclude hepatitis E, or magnetic resonance cholangiopancreatography to fully exclude biliary obstruction—would be useful, they said.

Such standards, which have been suggested in the past but not widely adopted, could be posted on a publicly funded Web site, with the goal that they would ultimately be adopted by journal editors, the authors suggested.

Major Finding: None of 97 analyzed case reports or series reports of drug-induced liver injury included all 42 elements, which the investigators deemed necessary for evaluating causality of such events. A median of 48% of the elements were missing in the reports.

Data Source: Retrospective analysis.

Disclosures: Funding for the Drug-Induced Liver Injury Network is provided by the National Institute of Diabetes and Digestive and Kidney Diseases; the study was conducted on behalf of this network. One author, Dr. John G. McHutchison, reported receiving research support from, and acting as a scientific adviser for, GlaxoSmithKline and Merck & Co.

Key clinical information is often lacking in published reports of drug-induced liver injury, Dr. Vijay K. Agarwal and his colleagues reported.

The finding is concerning, because accurate reporting of drug-induced liver injury—the single leading cause of acute liver failure in the United States—is essential for the development of reliable, interpretable data to help promote early detection and awareness of drug-induced hepatotoxicity, said Dr. Agarwal of Duke University, Durham, N.C., and colleagues.

For the study, which was conducted on behalf of the Drug-Induced Liver Injury Network, the investigators developed a list of 42 elements necessary for evaluating causality of drug-induced liver injury, and they analyzed 97 published case reports or series of such injuries for the presence of these elements.

Basic disease, drug, and demographic information was present in the vast majority of reports, but numerous important elements for determining causality and eliminating alternative causes of liver injury were lacking. These elements included bilirubin level (missing in 12% of reports), initial alkaline phosphatase level (missing in 58% of reports), and competing viral etiologies (missing in more than 50% of reports).

None of the reports included all 42 elements, which the investigators considered to be minimally necessary for evaluating the causes of the adverse effects. A median of 48% of the elements were missing in the reports.

The reports evaluated included 23 single case reports, 7 brief communications, 46 small case series, and 21 letters to the editor, and they focused on six drugs from three drug classes: amoxicillin/clavulanic acid (35 reports), troglitazone (32), rosiglitazone (10), pioglitazone (8), zafirlukast (8), and montelukast (4). The first two drugs are known to cause clinically apparent drug-induced liver disease, while the other four rarely cause liver injury, but case reports have been important in documenting the medications' potential for hepatotoxicity, the investigators noted.

Some studies included only vague descriptions of how certain diagnoses were excluded, and data on abnormal results from serial liver tests often were not included. Single case reports had significantly fewer missing elements than letters to the editor and small case series (a median of 33% vs. 50% and 48% of the elements were missing, respectively).

No significant differences were observed on the basis of journal type: The median percentage of missing elements was 50% for major internal medicine journals, 48% for gastroenterology and liver subspecialty journals, and 45% for other types of journals.

The authors noted that unless the essential details for interpreting the findings are included in such reports, it will be impossible to determine if episodes of hepatotoxicity can be causally assigned to a specific drug or combination of drugs. In addition, opportunities to identify rare events that might not be apparent in clinical trials, and to increase awareness of issues possibly associated with a drug early in its development and use, will be missed, the investigators said. They argued that a more standardized approach to the reporting of drug-induced liver injury is needed.

A checklist of minimal elements for diagnosing drug-related liver injury and for assessing causality should be developed, and a secondary list of elements that are helpful in many situations—such as results of assays for anti–hepatitis E virus antibodies to exclude hepatitis E, or magnetic resonance cholangiopancreatography to fully exclude biliary obstruction—would be useful, they said.

Such standards, which have been suggested in the past but not widely adopted, could be posted on a publicly funded Web site, with the goal that they would ultimately be adopted by journal editors, the authors suggested.

Major Finding: None of 97 analyzed case reports or series reports of drug-induced liver injury included all 42 elements, which the investigators deemed necessary for evaluating causality of such events. A median of 48% of the elements were missing in the reports.

Data Source: Retrospective analysis.

Disclosures: Funding for the Drug-Induced Liver Injury Network is provided by the National Institute of Diabetes and Digestive and Kidney Diseases; the study was conducted on behalf of this network. One author, Dr. John G. McHutchison, reported receiving research support from, and acting as a scientific adviser for, GlaxoSmithKline and Merck & Co.

Key clinical information is often lacking in published reports of drug-induced liver injury, Dr. Vijay K. Agarwal and his colleagues reported.

The finding is concerning, because accurate reporting of drug-induced liver injury—the single leading cause of acute liver failure in the United States—is essential for the development of reliable, interpretable data to help promote early detection and awareness of drug-induced hepatotoxicity, said Dr. Agarwal of Duke University, Durham, N.C., and colleagues.

For the study, which was conducted on behalf of the Drug-Induced Liver Injury Network, the investigators developed a list of 42 elements necessary for evaluating causality of drug-induced liver injury, and they analyzed 97 published case reports or series of such injuries for the presence of these elements.

Basic disease, drug, and demographic information was present in the vast majority of reports, but numerous important elements for determining causality and eliminating alternative causes of liver injury were lacking. These elements included bilirubin level (missing in 12% of reports), initial alkaline phosphatase level (missing in 58% of reports), and competing viral etiologies (missing in more than 50% of reports).

None of the reports included all 42 elements, which the investigators considered to be minimally necessary for evaluating the causes of the adverse effects. A median of 48% of the elements were missing in the reports.

The reports evaluated included 23 single case reports, 7 brief communications, 46 small case series, and 21 letters to the editor, and they focused on six drugs from three drug classes: amoxicillin/clavulanic acid (35 reports), troglitazone (32), rosiglitazone (10), pioglitazone (8), zafirlukast (8), and montelukast (4). The first two drugs are known to cause clinically apparent drug-induced liver disease, while the other four rarely cause liver injury, but case reports have been important in documenting the medications' potential for hepatotoxicity, the investigators noted.

Some studies included only vague descriptions of how certain diagnoses were excluded, and data on abnormal results from serial liver tests often were not included. Single case reports had significantly fewer missing elements than letters to the editor and small case series (a median of 33% vs. 50% and 48% of the elements were missing, respectively).

No significant differences were observed on the basis of journal type: The median percentage of missing elements was 50% for major internal medicine journals, 48% for gastroenterology and liver subspecialty journals, and 45% for other types of journals.

The authors noted that unless the essential details for interpreting the findings are included in such reports, it will be impossible to determine if episodes of hepatotoxicity can be causally assigned to a specific drug or combination of drugs. In addition, opportunities to identify rare events that might not be apparent in clinical trials, and to increase awareness of issues possibly associated with a drug early in its development and use, will be missed, the investigators said. They argued that a more standardized approach to the reporting of drug-induced liver injury is needed.

A checklist of minimal elements for diagnosing drug-related liver injury and for assessing causality should be developed, and a secondary list of elements that are helpful in many situations—such as results of assays for anti–hepatitis E virus antibodies to exclude hepatitis E, or magnetic resonance cholangiopancreatography to fully exclude biliary obstruction—would be useful, they said.

Such standards, which have been suggested in the past but not widely adopted, could be posted on a publicly funded Web site, with the goal that they would ultimately be adopted by journal editors, the authors suggested.

Major Finding: Annual incidence rates of hepatocellular carcinoma and liver-related death were 0.06% and 0.04%, respectively, among 1,932 carriers of inactive hepatitis B virus (HBV). The annual incidence rates were 0.02% for hepatocellular carcinoma and 0.02% for liver-related death among 18,137 controls.

Data Source: A prospective cohort study involving 20,069 subjects.

Disclosures: This study received grant support from Bristol-Myers Squibb Co.; Department of Health, Executive Yuan, National Health Research Institutes, Taiwan; and Academia Sinica, Taiwan. The investigators reported that there were no financial or other disclosures related to the study.

Carriers of inactive hepatitis B virus are at increased risk of hepatocellular carcinoma and liver-related death, compared with noncarriers, according to findings from a large, prospective cohort study.

The annual incidence rates of hepatocellular carcinoma and liver-related death in 20,069 participants in the study, which had a mean follow-up of more than 13 years, were 0.06% and 0.04%, respectively, among 1,932 carriers of inactive hepatitis B virus (HBV). The annual incidence rates were 0.02% for hepatocellular carcinoma and 0.02% for liver-related death among 18,137 controls, wrote Dr. Jin-De Chen of National Taiwan University Hospital, Taipei, and colleagues.

Multivariate-adjusted hazard ratios for carriers, compared with controls, were 4.6 and 2.1 for hepatocellular carcinoma and liver-related death, respectively, the investigators reported (Gastroenterology [doi: 10.1053/j.gastro.2010.01.042]).

The authors used data from the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-Hepatitis B Virus (REVEAL–HBV) Study for their analysis. Inactive HBV carriers were those who had seronegative hepatitis B e antigen status, anti–hepatitis C virus (HCV)-seronegative status, serum levels of HBV DNA less than 10,000 copies/mL without cirrhosis, hepatocellular carcinoma, or increased serum alanine transaminase (ALT) levels. Controls were participants who were seronegative for HB surface antigen and antibodies against HCV, but who had similar clinical liver features (normal serum ALT, without cirrhosis or hepatocellular carcinoma at study entry). Together, the groups contributed 262,122 person-years of follow-up.

Significant predictors of hepatocellular carcinoma in the entire cohort, compared with controls, were older age (hazard ratio of 2.7/10-year increment), high-normal baseline ALT level (HR 2.2), and alcohol drinking habit (HR 2.4). Significant predictors in inactive HBV carriers, compared with controls, were older age (HR 2.6/10-year increment) and drinking habit (HR 3.7).

The risk of hepatocellular carcinoma was higher in those with baseline serum HBV DNA levels of 300-10,000 copies/mL, compared with those with undetectable serum HBV DNA at baseline, but the difference did not reach statistical significance (HR 1.6). In inactive carriers with undetectable serum HBV DNA at baseline, alcohol drinking habit was a significant predictor of hepatocellular carcinoma (HR 6.9).

Significant predictors of liver-related death in the entire cohort, compared with controls, were similar to those for hepatocellular carcinoma, and included older age (HR 2.3/10-year increment), high-normal baseline serum ALT level (HR 1.9), and alcohol drinking habit (HR 2.1). Among inactive HBV carriers, only older age (HR 2.6/10-year increment) and alcohol drinking habit (HR 5.8) were significant predictors.

The inclusion of hepatocellular carcinoma as a time-dependent event in the analysis revealed that it was the most striking risk predictor for liver-related death (HR 611 for the entire cohort, and 451 for inactive HBV carriers), as would be expected, the investigators noted.

In those without newly developed hepatocellular carcinoma, older age (HR 2.0/10-year increment) and alcohol drinking habit (HR 2.3) were significant risk factors for liver-related death; in inactive carriers without hepatocellular carcinoma, only older age was a significant predictor (HR 2.4).

No significant differences were seen in the development of hepatocellular carcinoma or liver-related death between inactive carriers with undetectable and detectable serum HBV DNA, the investigators noted.

The study is limited by a lack of histologic data, since liver biopsies were not applicable in the large community-based study. Also, serial HBV DNA measurements were not taken to assess for continued inactive carriage, and other risk factors, such as HBV genotypes, were not assessed in those with HBV DNA levels greater than 100,000 copies/mL to determine an association with hepatocellular carcinoma in inactive carriers.

Future studies that include serial measurement of hepatitis B surface antigen serostatus and serum HBV DNA levels would help clarify the natural history of inactive HBV carriage, they concluded.

Major Finding: Annual incidence rates of hepatocellular carcinoma and liver-related death were 0.06% and 0.04%, respectively, among 1,932 carriers of inactive hepatitis B virus (HBV). The annual incidence rates were 0.02% for hepatocellular carcinoma and 0.02% for liver-related death among 18,137 controls.

Data Source: A prospective cohort study involving 20,069 subjects.

Disclosures: This study received grant support from Bristol-Myers Squibb Co.; Department of Health, Executive Yuan, National Health Research Institutes, Taiwan; and Academia Sinica, Taiwan. The investigators reported that there were no financial or other disclosures related to the study.

Carriers of inactive hepatitis B virus are at increased risk of hepatocellular carcinoma and liver-related death, compared with noncarriers, according to findings from a large, prospective cohort study.

The annual incidence rates of hepatocellular carcinoma and liver-related death in 20,069 participants in the study, which had a mean follow-up of more than 13 years, were 0.06% and 0.04%, respectively, among 1,932 carriers of inactive hepatitis B virus (HBV). The annual incidence rates were 0.02% for hepatocellular carcinoma and 0.02% for liver-related death among 18,137 controls, wrote Dr. Jin-De Chen of National Taiwan University Hospital, Taipei, and colleagues.

Multivariate-adjusted hazard ratios for carriers, compared with controls, were 4.6 and 2.1 for hepatocellular carcinoma and liver-related death, respectively, the investigators reported (Gastroenterology [doi: 10.1053/j.gastro.2010.01.042]).

The authors used data from the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-Hepatitis B Virus (REVEAL–HBV) Study for their analysis. Inactive HBV carriers were those who had seronegative hepatitis B e antigen status, anti–hepatitis C virus (HCV)-seronegative status, serum levels of HBV DNA less than 10,000 copies/mL without cirrhosis, hepatocellular carcinoma, or increased serum alanine transaminase (ALT) levels. Controls were participants who were seronegative for HB surface antigen and antibodies against HCV, but who had similar clinical liver features (normal serum ALT, without cirrhosis or hepatocellular carcinoma at study entry). Together, the groups contributed 262,122 person-years of follow-up.

Significant predictors of hepatocellular carcinoma in the entire cohort, compared with controls, were older age (hazard ratio of 2.7/10-year increment), high-normal baseline ALT level (HR 2.2), and alcohol drinking habit (HR 2.4). Significant predictors in inactive HBV carriers, compared with controls, were older age (HR 2.6/10-year increment) and drinking habit (HR 3.7).

The risk of hepatocellular carcinoma was higher in those with baseline serum HBV DNA levels of 300-10,000 copies/mL, compared with those with undetectable serum HBV DNA at baseline, but the difference did not reach statistical significance (HR 1.6). In inactive carriers with undetectable serum HBV DNA at baseline, alcohol drinking habit was a significant predictor of hepatocellular carcinoma (HR 6.9).

Significant predictors of liver-related death in the entire cohort, compared with controls, were similar to those for hepatocellular carcinoma, and included older age (HR 2.3/10-year increment), high-normal baseline serum ALT level (HR 1.9), and alcohol drinking habit (HR 2.1). Among inactive HBV carriers, only older age (HR 2.6/10-year increment) and alcohol drinking habit (HR 5.8) were significant predictors.

The inclusion of hepatocellular carcinoma as a time-dependent event in the analysis revealed that it was the most striking risk predictor for liver-related death (HR 611 for the entire cohort, and 451 for inactive HBV carriers), as would be expected, the investigators noted.

In those without newly developed hepatocellular carcinoma, older age (HR 2.0/10-year increment) and alcohol drinking habit (HR 2.3) were significant risk factors for liver-related death; in inactive carriers without hepatocellular carcinoma, only older age was a significant predictor (HR 2.4).

No significant differences were seen in the development of hepatocellular carcinoma or liver-related death between inactive carriers with undetectable and detectable serum HBV DNA, the investigators noted.

The study is limited by a lack of histologic data, since liver biopsies were not applicable in the large community-based study. Also, serial HBV DNA measurements were not taken to assess for continued inactive carriage, and other risk factors, such as HBV genotypes, were not assessed in those with HBV DNA levels greater than 100,000 copies/mL to determine an association with hepatocellular carcinoma in inactive carriers.

Future studies that include serial measurement of hepatitis B surface antigen serostatus and serum HBV DNA levels would help clarify the natural history of inactive HBV carriage, they concluded.

Major Finding: Annual incidence rates of hepatocellular carcinoma and liver-related death were 0.06% and 0.04%, respectively, among 1,932 carriers of inactive hepatitis B virus (HBV). The annual incidence rates were 0.02% for hepatocellular carcinoma and 0.02% for liver-related death among 18,137 controls.

Data Source: A prospective cohort study involving 20,069 subjects.

Disclosures: This study received grant support from Bristol-Myers Squibb Co.; Department of Health, Executive Yuan, National Health Research Institutes, Taiwan; and Academia Sinica, Taiwan. The investigators reported that there were no financial or other disclosures related to the study.

Carriers of inactive hepatitis B virus are at increased risk of hepatocellular carcinoma and liver-related death, compared with noncarriers, according to findings from a large, prospective cohort study.

The annual incidence rates of hepatocellular carcinoma and liver-related death in 20,069 participants in the study, which had a mean follow-up of more than 13 years, were 0.06% and 0.04%, respectively, among 1,932 carriers of inactive hepatitis B virus (HBV). The annual incidence rates were 0.02% for hepatocellular carcinoma and 0.02% for liver-related death among 18,137 controls, wrote Dr. Jin-De Chen of National Taiwan University Hospital, Taipei, and colleagues.

Multivariate-adjusted hazard ratios for carriers, compared with controls, were 4.6 and 2.1 for hepatocellular carcinoma and liver-related death, respectively, the investigators reported (Gastroenterology [doi: 10.1053/j.gastro.2010.01.042]).

The authors used data from the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-Hepatitis B Virus (REVEAL–HBV) Study for their analysis. Inactive HBV carriers were those who had seronegative hepatitis B e antigen status, anti–hepatitis C virus (HCV)-seronegative status, serum levels of HBV DNA less than 10,000 copies/mL without cirrhosis, hepatocellular carcinoma, or increased serum alanine transaminase (ALT) levels. Controls were participants who were seronegative for HB surface antigen and antibodies against HCV, but who had similar clinical liver features (normal serum ALT, without cirrhosis or hepatocellular carcinoma at study entry). Together, the groups contributed 262,122 person-years of follow-up.

Significant predictors of hepatocellular carcinoma in the entire cohort, compared with controls, were older age (hazard ratio of 2.7/10-year increment), high-normal baseline ALT level (HR 2.2), and alcohol drinking habit (HR 2.4). Significant predictors in inactive HBV carriers, compared with controls, were older age (HR 2.6/10-year increment) and drinking habit (HR 3.7).

The risk of hepatocellular carcinoma was higher in those with baseline serum HBV DNA levels of 300-10,000 copies/mL, compared with those with undetectable serum HBV DNA at baseline, but the difference did not reach statistical significance (HR 1.6). In inactive carriers with undetectable serum HBV DNA at baseline, alcohol drinking habit was a significant predictor of hepatocellular carcinoma (HR 6.9).

Significant predictors of liver-related death in the entire cohort, compared with controls, were similar to those for hepatocellular carcinoma, and included older age (HR 2.3/10-year increment), high-normal baseline serum ALT level (HR 1.9), and alcohol drinking habit (HR 2.1). Among inactive HBV carriers, only older age (HR 2.6/10-year increment) and alcohol drinking habit (HR 5.8) were significant predictors.

The inclusion of hepatocellular carcinoma as a time-dependent event in the analysis revealed that it was the most striking risk predictor for liver-related death (HR 611 for the entire cohort, and 451 for inactive HBV carriers), as would be expected, the investigators noted.

In those without newly developed hepatocellular carcinoma, older age (HR 2.0/10-year increment) and alcohol drinking habit (HR 2.3) were significant risk factors for liver-related death; in inactive carriers without hepatocellular carcinoma, only older age was a significant predictor (HR 2.4).

No significant differences were seen in the development of hepatocellular carcinoma or liver-related death between inactive carriers with undetectable and detectable serum HBV DNA, the investigators noted.

The study is limited by a lack of histologic data, since liver biopsies were not applicable in the large community-based study. Also, serial HBV DNA measurements were not taken to assess for continued inactive carriage, and other risk factors, such as HBV genotypes, were not assessed in those with HBV DNA levels greater than 100,000 copies/mL to determine an association with hepatocellular carcinoma in inactive carriers.

Future studies that include serial measurement of hepatitis B surface antigen serostatus and serum HBV DNA levels would help clarify the natural history of inactive HBV carriage, they concluded.

Major Finding: In patients with gastrointestinal bleeding, diagnostic yield was significantly greater in 66 patients randomized to undergo capsule endoscopy than in 70 who underwent dedicated small bowel contrast radiography (30% vs. 7%), but the primary end point of further bleeding occurred in 30% of the capsule endoscopy patients, compared with 24% of the contrast radiography patients.

Data Source: A randomized controlled trial.

Disclosures: This study received grant support from the American Society for Gastrointestinal Endoscopy Wireless Video Capsule Endoscopy Clinical Research Award. The authors reported that they have no disclosures relevant the study.

Capsule endoscopy improved diagnostic yield in patients with obscure gastrointestinal bleeding, but that did not translate into better outcomes in a randomized study comparing the procedure with dedicated small bowel contrast radiography.

Diagnostic yield was significantly greater in 66 patients randomized to undergo capsule endoscopy than in 70 who underwent dedicated small bowel contrast radiography (30% vs. 7%), but the primary end point of further bleeding occurred in 30% of the capsule endoscopy patients, compared with 24% of the contrast radiography patients, the investigators reported (Gastroenterology 2010 May[doi: 10.1053/j.gastro.2010.01.047]).

Patients in the study had an average age of about 55 years; 54 had overt bleeding and 82 had occult bleeding at randomization. Patients who had overt bleeding at randomization were almost twice as likely as those with occult bleeding to have further bleeding during the study; 39% vs. 20% had further bleeding in the overt and occult bleeding groups, respectively.

Also, those with overt bleeding at randomization who were assigned to the capsule endoscopy group were more likely to have further bleeding, compared with those with overt bleeding assigned to the radiography group (50% vs. 29% had further bleeding, respectively).

Those with occult bleeding at randomization had similar rates of further bleeding regardless of randomization; 18% and 21% had further bleeding in the capsule endoscopy and radiography groups, respectively, the investigators noted.

No significant differences were seen between the capsule endoscopy and radiography groups in regard to the need for transfusions, subsequent hospitalization, or additional interventions for diagnosis or treatment of bleeding, said Dr. Loren A. Laine of the University of Southern California, Los Angeles, and his colleagues.

The investigation findings demonstrate that most patients with obscure GI bleeding do well regardless of whether their abnormalities are detected by capsule endoscopy, and that further interventions might be necessary regardless of the success or failure of the procedure.

“In addition, merely visualizing a lesion on capsule (or radiography) does not document that the lesion is the cause of bleeding unless active bleeding or stigmata of recent hemorrhage are also identified,” they wrote.

The findings of this study have no bearing on current recommendations from the American Gastroenterological Association regarding the management of patients with obscure GI bleeding, because the study did not directly assess the AGA management algorithm, which calls for capsule endoscopy after a negative upper endoscopy and colonoscopy in those with obscure GI bleeding, subsequent interventions directed by the findings of a positive capsule endoscopy, and observation or—if warranted—further diagnostic testing in those with no bleeding source identified.

In this study, capsule endoscopy was evaluated only after patients had a negative upper endoscopy, colonoscopy, and push enteroscopy; the investigators used this approach because push enteroscopy has the ability to obtain diagnostic specimens and provide therapy, and because it is likely to identify nearly half of the abnormalities seen on capsule endoscopy, the explained.

“Future randomized trials will need to assess whether push enteroscopy or capsule should be the first test after negative upper endoscopy and colonoscopy and whether capsule endoscopy would improve outcomes if performed prior to push enteroscopy,” they said.

The investigation findings do not rule out the possibility that some patients may benefit from capsule endoscopy, they noted, adding that future studies also should attempt to identify clinical characteristics that help stratify the use of capsule endoscopy and other interventions.

However, the development of technology allowing external control in capsule endoscopy, and equipping it to perform diagnostic and therapeutic interventions, might be necessary before significant improvements in clinical outcomes associated with its use in this population become apparent, they concluded.

Major Finding: In patients with gastrointestinal bleeding, diagnostic yield was significantly greater in 66 patients randomized to undergo capsule endoscopy than in 70 who underwent dedicated small bowel contrast radiography (30% vs. 7%), but the primary end point of further bleeding occurred in 30% of the capsule endoscopy patients, compared with 24% of the contrast radiography patients.

Data Source: A randomized controlled trial.

Disclosures: This study received grant support from the American Society for Gastrointestinal Endoscopy Wireless Video Capsule Endoscopy Clinical Research Award. The authors reported that they have no disclosures relevant the study.

Capsule endoscopy improved diagnostic yield in patients with obscure gastrointestinal bleeding, but that did not translate into better outcomes in a randomized study comparing the procedure with dedicated small bowel contrast radiography.

Diagnostic yield was significantly greater in 66 patients randomized to undergo capsule endoscopy than in 70 who underwent dedicated small bowel contrast radiography (30% vs. 7%), but the primary end point of further bleeding occurred in 30% of the capsule endoscopy patients, compared with 24% of the contrast radiography patients, the investigators reported (Gastroenterology 2010 May[doi: 10.1053/j.gastro.2010.01.047]).

Patients in the study had an average age of about 55 years; 54 had overt bleeding and 82 had occult bleeding at randomization. Patients who had overt bleeding at randomization were almost twice as likely as those with occult bleeding to have further bleeding during the study; 39% vs. 20% had further bleeding in the overt and occult bleeding groups, respectively.

Also, those with overt bleeding at randomization who were assigned to the capsule endoscopy group were more likely to have further bleeding, compared with those with overt bleeding assigned to the radiography group (50% vs. 29% had further bleeding, respectively).

Those with occult bleeding at randomization had similar rates of further bleeding regardless of randomization; 18% and 21% had further bleeding in the capsule endoscopy and radiography groups, respectively, the investigators noted.

No significant differences were seen between the capsule endoscopy and radiography groups in regard to the need for transfusions, subsequent hospitalization, or additional interventions for diagnosis or treatment of bleeding, said Dr. Loren A. Laine of the University of Southern California, Los Angeles, and his colleagues.

The investigation findings demonstrate that most patients with obscure GI bleeding do well regardless of whether their abnormalities are detected by capsule endoscopy, and that further interventions might be necessary regardless of the success or failure of the procedure.

“In addition, merely visualizing a lesion on capsule (or radiography) does not document that the lesion is the cause of bleeding unless active bleeding or stigmata of recent hemorrhage are also identified,” they wrote.

The findings of this study have no bearing on current recommendations from the American Gastroenterological Association regarding the management of patients with obscure GI bleeding, because the study did not directly assess the AGA management algorithm, which calls for capsule endoscopy after a negative upper endoscopy and colonoscopy in those with obscure GI bleeding, subsequent interventions directed by the findings of a positive capsule endoscopy, and observation or—if warranted—further diagnostic testing in those with no bleeding source identified.

In this study, capsule endoscopy was evaluated only after patients had a negative upper endoscopy, colonoscopy, and push enteroscopy; the investigators used this approach because push enteroscopy has the ability to obtain diagnostic specimens and provide therapy, and because it is likely to identify nearly half of the abnormalities seen on capsule endoscopy, the explained.

“Future randomized trials will need to assess whether push enteroscopy or capsule should be the first test after negative upper endoscopy and colonoscopy and whether capsule endoscopy would improve outcomes if performed prior to push enteroscopy,” they said.

The investigation findings do not rule out the possibility that some patients may benefit from capsule endoscopy, they noted, adding that future studies also should attempt to identify clinical characteristics that help stratify the use of capsule endoscopy and other interventions.

However, the development of technology allowing external control in capsule endoscopy, and equipping it to perform diagnostic and therapeutic interventions, might be necessary before significant improvements in clinical outcomes associated with its use in this population become apparent, they concluded.

Major Finding: In patients with gastrointestinal bleeding, diagnostic yield was significantly greater in 66 patients randomized to undergo capsule endoscopy than in 70 who underwent dedicated small bowel contrast radiography (30% vs. 7%), but the primary end point of further bleeding occurred in 30% of the capsule endoscopy patients, compared with 24% of the contrast radiography patients.

Data Source: A randomized controlled trial.

Disclosures: This study received grant support from the American Society for Gastrointestinal Endoscopy Wireless Video Capsule Endoscopy Clinical Research Award. The authors reported that they have no disclosures relevant the study.

Capsule endoscopy improved diagnostic yield in patients with obscure gastrointestinal bleeding, but that did not translate into better outcomes in a randomized study comparing the procedure with dedicated small bowel contrast radiography.

Diagnostic yield was significantly greater in 66 patients randomized to undergo capsule endoscopy than in 70 who underwent dedicated small bowel contrast radiography (30% vs. 7%), but the primary end point of further bleeding occurred in 30% of the capsule endoscopy patients, compared with 24% of the contrast radiography patients, the investigators reported (Gastroenterology 2010 May[doi: 10.1053/j.gastro.2010.01.047]).

Patients in the study had an average age of about 55 years; 54 had overt bleeding and 82 had occult bleeding at randomization. Patients who had overt bleeding at randomization were almost twice as likely as those with occult bleeding to have further bleeding during the study; 39% vs. 20% had further bleeding in the overt and occult bleeding groups, respectively.

Also, those with overt bleeding at randomization who were assigned to the capsule endoscopy group were more likely to have further bleeding, compared with those with overt bleeding assigned to the radiography group (50% vs. 29% had further bleeding, respectively).

Those with occult bleeding at randomization had similar rates of further bleeding regardless of randomization; 18% and 21% had further bleeding in the capsule endoscopy and radiography groups, respectively, the investigators noted.

No significant differences were seen between the capsule endoscopy and radiography groups in regard to the need for transfusions, subsequent hospitalization, or additional interventions for diagnosis or treatment of bleeding, said Dr. Loren A. Laine of the University of Southern California, Los Angeles, and his colleagues.

The investigation findings demonstrate that most patients with obscure GI bleeding do well regardless of whether their abnormalities are detected by capsule endoscopy, and that further interventions might be necessary regardless of the success or failure of the procedure.

“In addition, merely visualizing a lesion on capsule (or radiography) does not document that the lesion is the cause of bleeding unless active bleeding or stigmata of recent hemorrhage are also identified,” they wrote.

The findings of this study have no bearing on current recommendations from the American Gastroenterological Association regarding the management of patients with obscure GI bleeding, because the study did not directly assess the AGA management algorithm, which calls for capsule endoscopy after a negative upper endoscopy and colonoscopy in those with obscure GI bleeding, subsequent interventions directed by the findings of a positive capsule endoscopy, and observation or—if warranted—further diagnostic testing in those with no bleeding source identified.

In this study, capsule endoscopy was evaluated only after patients had a negative upper endoscopy, colonoscopy, and push enteroscopy; the investigators used this approach because push enteroscopy has the ability to obtain diagnostic specimens and provide therapy, and because it is likely to identify nearly half of the abnormalities seen on capsule endoscopy, the explained.

“Future randomized trials will need to assess whether push enteroscopy or capsule should be the first test after negative upper endoscopy and colonoscopy and whether capsule endoscopy would improve outcomes if performed prior to push enteroscopy,” they said.

The investigation findings do not rule out the possibility that some patients may benefit from capsule endoscopy, they noted, adding that future studies also should attempt to identify clinical characteristics that help stratify the use of capsule endoscopy and other interventions.

However, the development of technology allowing external control in capsule endoscopy, and equipping it to perform diagnostic and therapeutic interventions, might be necessary before significant improvements in clinical outcomes associated with its use in this population become apparent, they concluded.