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Best HCV value? Screen all baby boomers, treat all infections
BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.
A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.
That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.
In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”
Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.
Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.
Higher costs, lower risks
Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.
The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.
Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.
To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.
The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.
Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.
The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.
The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.
A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.
HCV costlier than other conditions?
When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.
As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”
The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.
A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.
“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”
“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.
Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.
On Twitter @sherryboschert
AGA RESOURCE
View the technical review, guideline and clinical decision support tool at www.gastro.org/guideline. Join the guideline authors for a webinar about the guidelines on Jan. 29, 2015, at noon ET. Register at http://ow.ly/FWcsx.
Chronic HCV infection is a common worldwide problem afflicting approximately 170 million people. HCV has significant morbidity and mortality, and it is currently the leading indication for liver transplantation in the Western world. Yet, the natural history is long, and most patients are asymptomatic and will not develop advanced liver disease.
The recent year has been marked by the stunning approval in the U.S. of all-oral, interferon-free treatments for chronic HCV, including genotypes 1, 2, and 3. Approved regimens are characterized by excellent tolerability and cure (sustained virologic response, SVR) rates for most patient subgroups above 90%. For genotype 1, the most common in the U.S., SVR rates in excess of 95% were observed in clinical trials.
Since the regimens are so well tolerated and effective, the number of patients seeking therapy has increased dramatically. Because the medical regimens are expensive, there have been draconian restrictions by many third-party payers for provision of antiviral therapy for HCV patients. This has led to analyses on cost-effectiveness of contemporary therapy.
The article describing a study presented at AASLD 2014 by Younossi et al. is an important contribution to this discussion. Younossi assessed a computer simulation analysis comparing four strategies for screening and treatment of HCV plus an option of no screening or treatment. He found that birth cohort screening and treatment of all HCV patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY); well below the accepted threshold used to define cost-effectiveness in health care. The assumptions regarding cost of the regimens, the rates of cirrhosis, hepatocellular carcinoma, liver transplantation and liver-related death were appropriate. The conclusion that all baby boomers should be screened and treated is not surprising.
The savings did not include an estimated $3 billion dollars annually in savings from work productivity. The analysis also did not account for the costs associated with many extrahepatic manifestations of HCV including diabetes mellitus, lymphoma, cryoglublinemia, chronic renal disease, and others that are not associated with the stage of liver disease and have significant morbidity and mortality. All-cause mortality, not only liver-related mortality, has been shown to decline in patients treated successfully compared with unsuccessful therapeutic attempts.
Never before has there been a serious medical illness for which a well-tolerated and highly effective therapy is available that has been subject to denial of therapy based upon cost by third-party payers. This is an unfortunate precedent.
All patients do not require therapy on an urgent basis. However, the decision to initiate therapy should be between a patient and his or her health care provider. Although it would be best if the cost of the medications could be reduced, even at the current costs, Younossi’s study provides clear data to support identification and treatment of HCV patients sooner rather than later.
Dr. Steven L. Flamm is chief of transplantation hepatology and professor of medicine and surgery at Northwestern University Feinberg School of Medicine, Chicago. He is a speaker for AbbVie, Janssen, and Gilead; and consults for AbbVie, Gilead, Janssen, BMS, and Merck.
Chronic HCV infection is a common worldwide problem afflicting approximately 170 million people. HCV has significant morbidity and mortality, and it is currently the leading indication for liver transplantation in the Western world. Yet, the natural history is long, and most patients are asymptomatic and will not develop advanced liver disease.
The recent year has been marked by the stunning approval in the U.S. of all-oral, interferon-free treatments for chronic HCV, including genotypes 1, 2, and 3. Approved regimens are characterized by excellent tolerability and cure (sustained virologic response, SVR) rates for most patient subgroups above 90%. For genotype 1, the most common in the U.S., SVR rates in excess of 95% were observed in clinical trials.
Since the regimens are so well tolerated and effective, the number of patients seeking therapy has increased dramatically. Because the medical regimens are expensive, there have been draconian restrictions by many third-party payers for provision of antiviral therapy for HCV patients. This has led to analyses on cost-effectiveness of contemporary therapy.
The article describing a study presented at AASLD 2014 by Younossi et al. is an important contribution to this discussion. Younossi assessed a computer simulation analysis comparing four strategies for screening and treatment of HCV plus an option of no screening or treatment. He found that birth cohort screening and treatment of all HCV patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY); well below the accepted threshold used to define cost-effectiveness in health care. The assumptions regarding cost of the regimens, the rates of cirrhosis, hepatocellular carcinoma, liver transplantation and liver-related death were appropriate. The conclusion that all baby boomers should be screened and treated is not surprising.
The savings did not include an estimated $3 billion dollars annually in savings from work productivity. The analysis also did not account for the costs associated with many extrahepatic manifestations of HCV including diabetes mellitus, lymphoma, cryoglublinemia, chronic renal disease, and others that are not associated with the stage of liver disease and have significant morbidity and mortality. All-cause mortality, not only liver-related mortality, has been shown to decline in patients treated successfully compared with unsuccessful therapeutic attempts.
Never before has there been a serious medical illness for which a well-tolerated and highly effective therapy is available that has been subject to denial of therapy based upon cost by third-party payers. This is an unfortunate precedent.
All patients do not require therapy on an urgent basis. However, the decision to initiate therapy should be between a patient and his or her health care provider. Although it would be best if the cost of the medications could be reduced, even at the current costs, Younossi’s study provides clear data to support identification and treatment of HCV patients sooner rather than later.
Dr. Steven L. Flamm is chief of transplantation hepatology and professor of medicine and surgery at Northwestern University Feinberg School of Medicine, Chicago. He is a speaker for AbbVie, Janssen, and Gilead; and consults for AbbVie, Gilead, Janssen, BMS, and Merck.
Chronic HCV infection is a common worldwide problem afflicting approximately 170 million people. HCV has significant morbidity and mortality, and it is currently the leading indication for liver transplantation in the Western world. Yet, the natural history is long, and most patients are asymptomatic and will not develop advanced liver disease.
The recent year has been marked by the stunning approval in the U.S. of all-oral, interferon-free treatments for chronic HCV, including genotypes 1, 2, and 3. Approved regimens are characterized by excellent tolerability and cure (sustained virologic response, SVR) rates for most patient subgroups above 90%. For genotype 1, the most common in the U.S., SVR rates in excess of 95% were observed in clinical trials.
Since the regimens are so well tolerated and effective, the number of patients seeking therapy has increased dramatically. Because the medical regimens are expensive, there have been draconian restrictions by many third-party payers for provision of antiviral therapy for HCV patients. This has led to analyses on cost-effectiveness of contemporary therapy.
The article describing a study presented at AASLD 2014 by Younossi et al. is an important contribution to this discussion. Younossi assessed a computer simulation analysis comparing four strategies for screening and treatment of HCV plus an option of no screening or treatment. He found that birth cohort screening and treatment of all HCV patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY); well below the accepted threshold used to define cost-effectiveness in health care. The assumptions regarding cost of the regimens, the rates of cirrhosis, hepatocellular carcinoma, liver transplantation and liver-related death were appropriate. The conclusion that all baby boomers should be screened and treated is not surprising.
The savings did not include an estimated $3 billion dollars annually in savings from work productivity. The analysis also did not account for the costs associated with many extrahepatic manifestations of HCV including diabetes mellitus, lymphoma, cryoglublinemia, chronic renal disease, and others that are not associated with the stage of liver disease and have significant morbidity and mortality. All-cause mortality, not only liver-related mortality, has been shown to decline in patients treated successfully compared with unsuccessful therapeutic attempts.
Never before has there been a serious medical illness for which a well-tolerated and highly effective therapy is available that has been subject to denial of therapy based upon cost by third-party payers. This is an unfortunate precedent.
All patients do not require therapy on an urgent basis. However, the decision to initiate therapy should be between a patient and his or her health care provider. Although it would be best if the cost of the medications could be reduced, even at the current costs, Younossi’s study provides clear data to support identification and treatment of HCV patients sooner rather than later.
Dr. Steven L. Flamm is chief of transplantation hepatology and professor of medicine and surgery at Northwestern University Feinberg School of Medicine, Chicago. He is a speaker for AbbVie, Janssen, and Gilead; and consults for AbbVie, Gilead, Janssen, BMS, and Merck.
BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.
A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.
That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.
In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”
Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.
Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.
Higher costs, lower risks
Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.
The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.
Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.
To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.
The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.
Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.
The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.
The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.
A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.
HCV costlier than other conditions?
When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.
As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”
The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.
A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.
“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”
“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.
Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.
On Twitter @sherryboschert
AGA RESOURCE
View the technical review, guideline and clinical decision support tool at www.gastro.org/guideline. Join the guideline authors for a webinar about the guidelines on Jan. 29, 2015, at noon ET. Register at http://ow.ly/FWcsx.
BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.
A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.
That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.
In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”
Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.
Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.
Higher costs, lower risks
Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.
The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.
Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.
To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.
The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.
Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.
The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.
The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.
A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.
HCV costlier than other conditions?
When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.
As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”
The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.
A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.
“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”
“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.
Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.
On Twitter @sherryboschert
AGA RESOURCE
View the technical review, guideline and clinical decision support tool at www.gastro.org/guideline. Join the guideline authors for a webinar about the guidelines on Jan. 29, 2015, at noon ET. Register at http://ow.ly/FWcsx.
AT THE LIVER MEETING 2014
Key clinical point: Screening adults born in 1945-1965 and treating all who have HCV with oral anti-HCV regimens is most cost effective.
Major finding: The strategy’s incremental cost of $36,585 is below the $50,000 per QALY threshold for cost effectiveness.
Data source: A computer simulation analysis that compared four strategies for screening and treatment, with treatment costs based on an estimated $1,000/day for sofosbuvir.
Disclosures: Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead, which markets sofosbuvir, and Bristol-Myers Squibb.
Adding terlipressin didn’t help hepatorenal syndrome
BOSTON – Treating patients with hepatorenal syndrome type 1 for up to 14 days using terlipressin plus albumin rather than albumin alone did not improve the chances of confirmed reversal of hepatorenal syndrome in a multicenter, randomized, double-blind, placebo-controlled trial in 196 patients.
Investigators confirmed reversal of hepatorenal syndrome type 1 (HRS-1) in 19 of 97 patients on terlipressin plus albumin (20%) and 13 of 99 patients on albumin plus placebo (13%), a difference between groups that was not statistically significant, Dr. Thomas D. Boyer reported at the annual meeting of the American Association for the Study of Liver Diseases.
He and his associates defined confirmed reversal of HRS-1 as two serum creatinine values no higher than 1.5 mg/dL at least 48 hours apart while on treatment, without renal replacement therapy or liver transplant.
Secondary outcomes included reversal of HRS-1, defined as a decrease in serum creatinine to no higher than 1.5 mg/dL. This goal was reached by 23 patients on terlipressin plus albumin, and 15 patients on albumin alone achieved reversal of HRS-1 (24% vs. 15%, respectively), a difference that also was not statistically significant.
Among other secondary outcomes, though, terlipressin showed some potential advantages in subgroup analyses, said Dr. Boyer, professor of medicine and director of the Liver Research Institute at the University of Arizona, Tucson.
Significantly greater improvements in serum creatinine during treatment with terlipressin correlated with survival. Compared with baseline levels, serum creatinine decreased by 1.2 mg/dL in the terlipressin group and 0.6 mg/dL in the placebo group, a statistically significant difference between groups.
All 19 patients who achieve confirmed reversal of HRS-1 on terlipressin were alive without renal replacement therapy at 90-day follow-up, significantly more than the 6 of 13 patients with confirmed reversal of HRS-1 in the placebo group who remained alive at 90 days (46%).
Overall survival and transplant-free survival rates did not differ significantly between groups.
Serious adverse events occurred in 59 patients in the terlipressin group (61%) and 53 patients in the placebo group (54%), rates that did not differ significantly between groups. No new or unexpected adverse events were seen.
The REVERSE trial (Phase III, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 with Lucassin [Terlipressin]) enrolled adults with cirrhosis, ascites, and HRS-1. The study defined HRS-1 as rapidly deteriorating renal function that didn’t improve within 48 hours of diuretic withdrawal and albumin-fluid challenge. Rapidly deteriorating renal function was defined as a serum creatinine level of at least 2.5 mg/dL and actual or projected doubling of serum creatinine within 2 weeks. Improvement in renal function was defined as less than a 20% decrease in serum creatinine and a serum creatinine level of at least 2.5 mg/dL.
Patients received IV infusions of 6 mg terlipressin or placebo every 6 hours, plus albumin.
Ikaria, which markets terlipressin (Lucassin), funded the study. Dr. Boyer is a consultant for Ikaria and he reported financial associations with AbbVie, Gilead, and Merck. His associates reported financial associations with Ikaria and multiple companies.
On Twitter @sherryboschert
BOSTON – Treating patients with hepatorenal syndrome type 1 for up to 14 days using terlipressin plus albumin rather than albumin alone did not improve the chances of confirmed reversal of hepatorenal syndrome in a multicenter, randomized, double-blind, placebo-controlled trial in 196 patients.
Investigators confirmed reversal of hepatorenal syndrome type 1 (HRS-1) in 19 of 97 patients on terlipressin plus albumin (20%) and 13 of 99 patients on albumin plus placebo (13%), a difference between groups that was not statistically significant, Dr. Thomas D. Boyer reported at the annual meeting of the American Association for the Study of Liver Diseases.
He and his associates defined confirmed reversal of HRS-1 as two serum creatinine values no higher than 1.5 mg/dL at least 48 hours apart while on treatment, without renal replacement therapy or liver transplant.
Secondary outcomes included reversal of HRS-1, defined as a decrease in serum creatinine to no higher than 1.5 mg/dL. This goal was reached by 23 patients on terlipressin plus albumin, and 15 patients on albumin alone achieved reversal of HRS-1 (24% vs. 15%, respectively), a difference that also was not statistically significant.
Among other secondary outcomes, though, terlipressin showed some potential advantages in subgroup analyses, said Dr. Boyer, professor of medicine and director of the Liver Research Institute at the University of Arizona, Tucson.
Significantly greater improvements in serum creatinine during treatment with terlipressin correlated with survival. Compared with baseline levels, serum creatinine decreased by 1.2 mg/dL in the terlipressin group and 0.6 mg/dL in the placebo group, a statistically significant difference between groups.
All 19 patients who achieve confirmed reversal of HRS-1 on terlipressin were alive without renal replacement therapy at 90-day follow-up, significantly more than the 6 of 13 patients with confirmed reversal of HRS-1 in the placebo group who remained alive at 90 days (46%).
Overall survival and transplant-free survival rates did not differ significantly between groups.
Serious adverse events occurred in 59 patients in the terlipressin group (61%) and 53 patients in the placebo group (54%), rates that did not differ significantly between groups. No new or unexpected adverse events were seen.
The REVERSE trial (Phase III, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 with Lucassin [Terlipressin]) enrolled adults with cirrhosis, ascites, and HRS-1. The study defined HRS-1 as rapidly deteriorating renal function that didn’t improve within 48 hours of diuretic withdrawal and albumin-fluid challenge. Rapidly deteriorating renal function was defined as a serum creatinine level of at least 2.5 mg/dL and actual or projected doubling of serum creatinine within 2 weeks. Improvement in renal function was defined as less than a 20% decrease in serum creatinine and a serum creatinine level of at least 2.5 mg/dL.
Patients received IV infusions of 6 mg terlipressin or placebo every 6 hours, plus albumin.
Ikaria, which markets terlipressin (Lucassin), funded the study. Dr. Boyer is a consultant for Ikaria and he reported financial associations with AbbVie, Gilead, and Merck. His associates reported financial associations with Ikaria and multiple companies.
On Twitter @sherryboschert
BOSTON – Treating patients with hepatorenal syndrome type 1 for up to 14 days using terlipressin plus albumin rather than albumin alone did not improve the chances of confirmed reversal of hepatorenal syndrome in a multicenter, randomized, double-blind, placebo-controlled trial in 196 patients.
Investigators confirmed reversal of hepatorenal syndrome type 1 (HRS-1) in 19 of 97 patients on terlipressin plus albumin (20%) and 13 of 99 patients on albumin plus placebo (13%), a difference between groups that was not statistically significant, Dr. Thomas D. Boyer reported at the annual meeting of the American Association for the Study of Liver Diseases.
He and his associates defined confirmed reversal of HRS-1 as two serum creatinine values no higher than 1.5 mg/dL at least 48 hours apart while on treatment, without renal replacement therapy or liver transplant.
Secondary outcomes included reversal of HRS-1, defined as a decrease in serum creatinine to no higher than 1.5 mg/dL. This goal was reached by 23 patients on terlipressin plus albumin, and 15 patients on albumin alone achieved reversal of HRS-1 (24% vs. 15%, respectively), a difference that also was not statistically significant.
Among other secondary outcomes, though, terlipressin showed some potential advantages in subgroup analyses, said Dr. Boyer, professor of medicine and director of the Liver Research Institute at the University of Arizona, Tucson.
Significantly greater improvements in serum creatinine during treatment with terlipressin correlated with survival. Compared with baseline levels, serum creatinine decreased by 1.2 mg/dL in the terlipressin group and 0.6 mg/dL in the placebo group, a statistically significant difference between groups.
All 19 patients who achieve confirmed reversal of HRS-1 on terlipressin were alive without renal replacement therapy at 90-day follow-up, significantly more than the 6 of 13 patients with confirmed reversal of HRS-1 in the placebo group who remained alive at 90 days (46%).
Overall survival and transplant-free survival rates did not differ significantly between groups.
Serious adverse events occurred in 59 patients in the terlipressin group (61%) and 53 patients in the placebo group (54%), rates that did not differ significantly between groups. No new or unexpected adverse events were seen.
The REVERSE trial (Phase III, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 with Lucassin [Terlipressin]) enrolled adults with cirrhosis, ascites, and HRS-1. The study defined HRS-1 as rapidly deteriorating renal function that didn’t improve within 48 hours of diuretic withdrawal and albumin-fluid challenge. Rapidly deteriorating renal function was defined as a serum creatinine level of at least 2.5 mg/dL and actual or projected doubling of serum creatinine within 2 weeks. Improvement in renal function was defined as less than a 20% decrease in serum creatinine and a serum creatinine level of at least 2.5 mg/dL.
Patients received IV infusions of 6 mg terlipressin or placebo every 6 hours, plus albumin.
Ikaria, which markets terlipressin (Lucassin), funded the study. Dr. Boyer is a consultant for Ikaria and he reported financial associations with AbbVie, Gilead, and Merck. His associates reported financial associations with Ikaria and multiple companies.
On Twitter @sherryboschert
AT THE LIVER MEETING 2014
Key clinical point: Adding terlipressin to albumin didn’t help reverse hepatorenal syndrome type 1, but there were hints of improved survival.
Major finding: Confirmed reversal of HRS-1 occurred in 20% on terlipressin and albumin and 13% on placebo and albumin.
Data source: A multicenter, randomized, controlled, double-blind trial in 196 adults with cirrhosis, ascites, and HRS-1.
Disclosures: Ikaria, which markets terlipressin (Lucassin), funded the study. Dr. Boyer is a consultant for Ikaria and he reported financial associations with AbbVie, Gilead, and Merck. His associates reported financial associations with Ikaria and multiple companies.
Ob.gyn. residents feel lack of fertility support
HONOLULU – Infertility may be as common among ob.gyn. residents as in the general population, and their residency programs may be providing little support for the problem, a survey of 254 residents suggests.
Investigators e-mailed a Web-based cross-sectional survey to all 233 ob.gyn. residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME) and received 254 of a possible 5,168 responses, for a 5% response rate.
Of the 220 respondents who answered questions about infertility, 18 (8%) reported experiencing fertility problems themselves. Previous data suggest an infertility prevalence of 9%-18% in the general population, Dr. Lusine Aghajanova and her colleagues reported at the annual meeting of the American Society for Reproductive Medicine.
Of the 18 residents reporting infertility issues, 14 said they sought treatment. The remaining four respondents said they could not afford treatment or did not have time to get it, according to Dr. Aghajanova of the University of California, San Francisco.
Eight of the 14 residents who sought treatment attempted in vitro fertilization and 3 attempted intrauterine insemination. A minority of respondents who sought help for infertility did so at the same clinic where they rotated as residents. More than a third of these respondents said their program administrators and coresidents were aware of their fertility problems, and more than a third reported stigma associated with their infertility.
A majority of respondents with infertility reported some or great difficulty in attending appointments for fertility services because of clinic schedules or other barriers, and only 3 of the 18 residents with fertility issues said they had good support from their residency program for the problem.
Ob.gyn. residents “should be considered a ‘population in need’ due to lack of program support and significant time constraints,” Dr. Aghajanova said.
Among the total cohort, 91% were female and 54% were younger than 30 years old, with 40% aged 30-35 years and the rest over 35. Fifteen percent said they were attempting conception. Twenty-nine percent reported that they had considered oocyte cryopreservation, but 2% had sought a consultation for this.
One physician in the audience questioned the generalizability of the survey results given the low response rate of 5%. Dr. Aghajanova suggested that the findings can be generalized, but with great caution.
Dr. Aghajanova reported having no financial disclosures.
On Twitter @sherryboschert
HONOLULU – Infertility may be as common among ob.gyn. residents as in the general population, and their residency programs may be providing little support for the problem, a survey of 254 residents suggests.
Investigators e-mailed a Web-based cross-sectional survey to all 233 ob.gyn. residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME) and received 254 of a possible 5,168 responses, for a 5% response rate.
Of the 220 respondents who answered questions about infertility, 18 (8%) reported experiencing fertility problems themselves. Previous data suggest an infertility prevalence of 9%-18% in the general population, Dr. Lusine Aghajanova and her colleagues reported at the annual meeting of the American Society for Reproductive Medicine.
Of the 18 residents reporting infertility issues, 14 said they sought treatment. The remaining four respondents said they could not afford treatment or did not have time to get it, according to Dr. Aghajanova of the University of California, San Francisco.
Eight of the 14 residents who sought treatment attempted in vitro fertilization and 3 attempted intrauterine insemination. A minority of respondents who sought help for infertility did so at the same clinic where they rotated as residents. More than a third of these respondents said their program administrators and coresidents were aware of their fertility problems, and more than a third reported stigma associated with their infertility.
A majority of respondents with infertility reported some or great difficulty in attending appointments for fertility services because of clinic schedules or other barriers, and only 3 of the 18 residents with fertility issues said they had good support from their residency program for the problem.
Ob.gyn. residents “should be considered a ‘population in need’ due to lack of program support and significant time constraints,” Dr. Aghajanova said.
Among the total cohort, 91% were female and 54% were younger than 30 years old, with 40% aged 30-35 years and the rest over 35. Fifteen percent said they were attempting conception. Twenty-nine percent reported that they had considered oocyte cryopreservation, but 2% had sought a consultation for this.
One physician in the audience questioned the generalizability of the survey results given the low response rate of 5%. Dr. Aghajanova suggested that the findings can be generalized, but with great caution.
Dr. Aghajanova reported having no financial disclosures.
On Twitter @sherryboschert
HONOLULU – Infertility may be as common among ob.gyn. residents as in the general population, and their residency programs may be providing little support for the problem, a survey of 254 residents suggests.
Investigators e-mailed a Web-based cross-sectional survey to all 233 ob.gyn. residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME) and received 254 of a possible 5,168 responses, for a 5% response rate.
Of the 220 respondents who answered questions about infertility, 18 (8%) reported experiencing fertility problems themselves. Previous data suggest an infertility prevalence of 9%-18% in the general population, Dr. Lusine Aghajanova and her colleagues reported at the annual meeting of the American Society for Reproductive Medicine.
Of the 18 residents reporting infertility issues, 14 said they sought treatment. The remaining four respondents said they could not afford treatment or did not have time to get it, according to Dr. Aghajanova of the University of California, San Francisco.
Eight of the 14 residents who sought treatment attempted in vitro fertilization and 3 attempted intrauterine insemination. A minority of respondents who sought help for infertility did so at the same clinic where they rotated as residents. More than a third of these respondents said their program administrators and coresidents were aware of their fertility problems, and more than a third reported stigma associated with their infertility.
A majority of respondents with infertility reported some or great difficulty in attending appointments for fertility services because of clinic schedules or other barriers, and only 3 of the 18 residents with fertility issues said they had good support from their residency program for the problem.
Ob.gyn. residents “should be considered a ‘population in need’ due to lack of program support and significant time constraints,” Dr. Aghajanova said.
Among the total cohort, 91% were female and 54% were younger than 30 years old, with 40% aged 30-35 years and the rest over 35. Fifteen percent said they were attempting conception. Twenty-nine percent reported that they had considered oocyte cryopreservation, but 2% had sought a consultation for this.
One physician in the audience questioned the generalizability of the survey results given the low response rate of 5%. Dr. Aghajanova suggested that the findings can be generalized, but with great caution.
Dr. Aghajanova reported having no financial disclosures.
On Twitter @sherryboschert
AT 2014 ASRM
Diet, exercise reduced portal hypertension in obese cirrhotic patients
BOSTON – A 16-week diet and exercise program reduced body weight and portal pressure in a prospective pilot study of 50 obese patients with cirrhosis and portal hypertension.
Twenty-six patients achieved a clinically relevant weight loss of at least 5%, compared with baseline weight (52% of the cohort). The hepatic venous pressure gradient (HVPG) decreased by at least 10% in 21 patients (42%), compared with baseline, Dr. Annalisa Berzigotti and her associates reported at the annual meeting of the American Association for the Study of Liver Diseases.
Obesity has been shown to increase the risk of clinical decompensation in patients with compensated cirrhosis and portal hypertension, possibly by increasing portal hypertension, said Dr. Berzigotti of the Networked Research Center for Hepatic and Digestive Diseases (CIBERehd), Barcelona.
“An intensive 16-week program of tailored diet and moderate exercise can be safely recommended to obtain weight loss,” she said.
Dr. Berzigotti and her associates at two Spanish centers put patients through a 16-week program of a normoproteic, hypocaloric diet supervised by nutritionists. It followed a personalized decrease of 500-1,000 kcal/day, with 20%-25% of the diet consisting of proteins. The exercise intervention consisted of 60 minutes per week of supervised, moderately-intense physical activity in small groups plus personalized advice and use of a daily physical activity log.
Patients had a baseline HVPG of at least 6 mm Hg with or without esophageal varices and regardless of whether they were receiving nonselective beta-blocker medications.
The investigators recruited 60 patients, 50 of whom completed the study and were included in the analysis.
The lifestyle intervention decreased the mean body weight by 5 kg and the median body weight by 5%, which was associated with significant decreases in waist circumference and percentage body fat. Eight patients achieved at least a 10% reduction in body weight (16%), she reported.
The mean HVPG decreased significantly from 13.9 mm Hg at baseline to 12.3 mm Hg after treatment, with an average 11% reduction. The HVPG decreased by at least 20% in 12 patients (24%).
Four patients who lost at least 5% of their body weight reduced their HVPG to below 10 mm Hg. Patients who lost at least 10% of body weight reduced their HVPG to a greater degree than did patients who lost less than 10% of body weight, with 24% and 8% reductions in HVPG, respectively.
Changes in body weight and HVPG were more subtle in patients with diabetes than in those without diabetes. Results did not differ significantly across other subgroups based on cirrhosis etiology, clinically significant portal hypertension and esophageal varices, treatment with nonselective beta-blockers, history of variceal bleeding, or medical center.
No patients clinically decompensated during the study. Patients’ Child-Pugh scores and Model for End-Stage Liver Disease scores did not change.
Patients who lost weight kept it off for 6 months, with average weights of 86 kg at 16 weeks and 85 kg at a 6-month follow-up.
Patients had a mean age of 56 years and 62% were male. The etiologies of cirrhosis were viral in 36% of patients, alcoholic in 38%, and nonalcoholic steatohepatitis in 26%. Patients had an average body mass index of 33 kg/m2, and 72% had an HVPG of at least 10 mm Hg at baseline. Thirty percent of patients had a previous variceal hemorrhage but currently were compensated. Sixty-two percent of patients had a history of esophageal varices and 60% were on nonselective beta-blockers.
Dr. Berzigotti reported having no financial disclosures. One of her associates reported financial associations with Falk, Gilead, Norgine, Ono Pharma USA, Intercept Pharmaceuticals, Exalenz Bioscience, Almirall, and Conatus Pharmaceuticals.
On Twitter @sherryboschert
BOSTON – A 16-week diet and exercise program reduced body weight and portal pressure in a prospective pilot study of 50 obese patients with cirrhosis and portal hypertension.
Twenty-six patients achieved a clinically relevant weight loss of at least 5%, compared with baseline weight (52% of the cohort). The hepatic venous pressure gradient (HVPG) decreased by at least 10% in 21 patients (42%), compared with baseline, Dr. Annalisa Berzigotti and her associates reported at the annual meeting of the American Association for the Study of Liver Diseases.
Obesity has been shown to increase the risk of clinical decompensation in patients with compensated cirrhosis and portal hypertension, possibly by increasing portal hypertension, said Dr. Berzigotti of the Networked Research Center for Hepatic and Digestive Diseases (CIBERehd), Barcelona.
“An intensive 16-week program of tailored diet and moderate exercise can be safely recommended to obtain weight loss,” she said.
Dr. Berzigotti and her associates at two Spanish centers put patients through a 16-week program of a normoproteic, hypocaloric diet supervised by nutritionists. It followed a personalized decrease of 500-1,000 kcal/day, with 20%-25% of the diet consisting of proteins. The exercise intervention consisted of 60 minutes per week of supervised, moderately-intense physical activity in small groups plus personalized advice and use of a daily physical activity log.
Patients had a baseline HVPG of at least 6 mm Hg with or without esophageal varices and regardless of whether they were receiving nonselective beta-blocker medications.
The investigators recruited 60 patients, 50 of whom completed the study and were included in the analysis.
The lifestyle intervention decreased the mean body weight by 5 kg and the median body weight by 5%, which was associated with significant decreases in waist circumference and percentage body fat. Eight patients achieved at least a 10% reduction in body weight (16%), she reported.
The mean HVPG decreased significantly from 13.9 mm Hg at baseline to 12.3 mm Hg after treatment, with an average 11% reduction. The HVPG decreased by at least 20% in 12 patients (24%).
Four patients who lost at least 5% of their body weight reduced their HVPG to below 10 mm Hg. Patients who lost at least 10% of body weight reduced their HVPG to a greater degree than did patients who lost less than 10% of body weight, with 24% and 8% reductions in HVPG, respectively.
Changes in body weight and HVPG were more subtle in patients with diabetes than in those without diabetes. Results did not differ significantly across other subgroups based on cirrhosis etiology, clinically significant portal hypertension and esophageal varices, treatment with nonselective beta-blockers, history of variceal bleeding, or medical center.
No patients clinically decompensated during the study. Patients’ Child-Pugh scores and Model for End-Stage Liver Disease scores did not change.
Patients who lost weight kept it off for 6 months, with average weights of 86 kg at 16 weeks and 85 kg at a 6-month follow-up.
Patients had a mean age of 56 years and 62% were male. The etiologies of cirrhosis were viral in 36% of patients, alcoholic in 38%, and nonalcoholic steatohepatitis in 26%. Patients had an average body mass index of 33 kg/m2, and 72% had an HVPG of at least 10 mm Hg at baseline. Thirty percent of patients had a previous variceal hemorrhage but currently were compensated. Sixty-two percent of patients had a history of esophageal varices and 60% were on nonselective beta-blockers.
Dr. Berzigotti reported having no financial disclosures. One of her associates reported financial associations with Falk, Gilead, Norgine, Ono Pharma USA, Intercept Pharmaceuticals, Exalenz Bioscience, Almirall, and Conatus Pharmaceuticals.
On Twitter @sherryboschert
BOSTON – A 16-week diet and exercise program reduced body weight and portal pressure in a prospective pilot study of 50 obese patients with cirrhosis and portal hypertension.
Twenty-six patients achieved a clinically relevant weight loss of at least 5%, compared with baseline weight (52% of the cohort). The hepatic venous pressure gradient (HVPG) decreased by at least 10% in 21 patients (42%), compared with baseline, Dr. Annalisa Berzigotti and her associates reported at the annual meeting of the American Association for the Study of Liver Diseases.
Obesity has been shown to increase the risk of clinical decompensation in patients with compensated cirrhosis and portal hypertension, possibly by increasing portal hypertension, said Dr. Berzigotti of the Networked Research Center for Hepatic and Digestive Diseases (CIBERehd), Barcelona.
“An intensive 16-week program of tailored diet and moderate exercise can be safely recommended to obtain weight loss,” she said.
Dr. Berzigotti and her associates at two Spanish centers put patients through a 16-week program of a normoproteic, hypocaloric diet supervised by nutritionists. It followed a personalized decrease of 500-1,000 kcal/day, with 20%-25% of the diet consisting of proteins. The exercise intervention consisted of 60 minutes per week of supervised, moderately-intense physical activity in small groups plus personalized advice and use of a daily physical activity log.
Patients had a baseline HVPG of at least 6 mm Hg with or without esophageal varices and regardless of whether they were receiving nonselective beta-blocker medications.
The investigators recruited 60 patients, 50 of whom completed the study and were included in the analysis.
The lifestyle intervention decreased the mean body weight by 5 kg and the median body weight by 5%, which was associated with significant decreases in waist circumference and percentage body fat. Eight patients achieved at least a 10% reduction in body weight (16%), she reported.
The mean HVPG decreased significantly from 13.9 mm Hg at baseline to 12.3 mm Hg after treatment, with an average 11% reduction. The HVPG decreased by at least 20% in 12 patients (24%).
Four patients who lost at least 5% of their body weight reduced their HVPG to below 10 mm Hg. Patients who lost at least 10% of body weight reduced their HVPG to a greater degree than did patients who lost less than 10% of body weight, with 24% and 8% reductions in HVPG, respectively.
Changes in body weight and HVPG were more subtle in patients with diabetes than in those without diabetes. Results did not differ significantly across other subgroups based on cirrhosis etiology, clinically significant portal hypertension and esophageal varices, treatment with nonselective beta-blockers, history of variceal bleeding, or medical center.
No patients clinically decompensated during the study. Patients’ Child-Pugh scores and Model for End-Stage Liver Disease scores did not change.
Patients who lost weight kept it off for 6 months, with average weights of 86 kg at 16 weeks and 85 kg at a 6-month follow-up.
Patients had a mean age of 56 years and 62% were male. The etiologies of cirrhosis were viral in 36% of patients, alcoholic in 38%, and nonalcoholic steatohepatitis in 26%. Patients had an average body mass index of 33 kg/m2, and 72% had an HVPG of at least 10 mm Hg at baseline. Thirty percent of patients had a previous variceal hemorrhage but currently were compensated. Sixty-two percent of patients had a history of esophageal varices and 60% were on nonselective beta-blockers.
Dr. Berzigotti reported having no financial disclosures. One of her associates reported financial associations with Falk, Gilead, Norgine, Ono Pharma USA, Intercept Pharmaceuticals, Exalenz Bioscience, Almirall, and Conatus Pharmaceuticals.
On Twitter @sherryboschert
AT THE LIVER MEETING 2014
Key clinical point: A 16-week lifestyle intervention safely reduced body weight and portal pressure in obese patients with cirrhosis.
Major finding: Clinically relevant weight loss occurred in 26 patients (52%) and the HVPG decreased by at least 10% in 21 patients (42%), compared with baseline.
Data source: A prospective, multicenter pilot study of 50 obese patients with cirrhosis and portal hypertension.
Disclosures:Dr. Berzigotti reported having no financial disclosures. One of her associates reported ties with Falk, Gilead, Norgine, Ono Pharma USA, Intercept Pharmaceuticals, Exalenz Bioscience, Almirall, and Conatus Pharmaceuticals.
Vasopressor terlipressin helped patients with cirrhosis, shock
BOSTON – Terlipressin proved noninferior to noradrenaline as a vasopressor for patients with cirrhosis and septic shock in an open-label study that randomized 84 patients.
Terlipressin also seemed to provide advantages over noradrenaline by contributing to greater hemodynamic stability, improved urine output, reduced variceal bleeding, a lower risk of spontaneous bacterial peritonitis, and reduced mortality in the first 48 hours but not at 28 days, Dr. Ashok K. Choudhury and his associates reported.
“Terlipressin is noninferior to noradrenaline as a vasopressor,” he said at the annual meeting of the American Association for the Study of Liver Diseases.
The investigators randomized consecutive, matched adults with cirrhosis and septic shock not responding to fluid resuscitation for 2 hours. They aimed to achieve a mean arterial pressure (MAP) > 65 mm Hg at 6 hours by treating 42 patients with a continuous infusion of terlipressin 1.3-5.2 mcg/min, stepped up every 15 minutes, and 42 patients with noradrenaline 7.5-6 mcg/min, stepped up every 15 minutes. Both groups received standard medical care of intravenous fluids, antibiotics, and ICU care.
The target MAP was reached within 6 hours in 28 patients on terlipressin (67%) and 23 patients on noradrenaline (55%), a difference that was not statistically significant, said Dr. Choudhury of the Institute of Liver and Biliary Sciences, New Delhi. He won a research award from the Association.
Patients in the two groups were matched by age, sex, etiology and severity of cirrhosis, and scores on the Model for End-Stage Liver Disease and the Sequential Organ Failure Assessment.
Spontaneous bacterial peritonitis was the main cause of sepsis at admission, followed by pneumonia, but pneumonia was the main cause of “second hit” pneumonia, he said.
Terlipressin therapy was associated with a lower failure rate at 6 hours, a greater likelihood of MAP maintenance with cessation of vasopressor requirements at 48 hours, and improved urine output at 24 hours, compared with noradrenaline treatment. At 48 hours, 19 of 40 patients on terlipressin (48%) and 11 of 30 patients on noradrenaline (36%) had an MAP > 65 mm Hg.
No patients on terlipressin developed a variceal bleed, compared with seven patients in the noradrenaline group (10%). Overall rates of adverse events did not differ significantly between groups, but were higher in the terlipressin group than in the noradrenaline group.
Better rates of lactate clearance, central venous oxygen saturation, and carbon dioxide gradient in venous-arterial blood gases in the terlipressin group were not statistically different from rates in the noradrenaline group.
Significantly more patients on terlipressin survived the first 48 hours than patients on noradrenaline, but by day 28 of follow-up survival rates did not differ significantly between groups.
On the whole, septic shock in these patients with cirrhosis was associated with a high mortality rate (80%). Twelve percent of patients were responsive to fluids in 2 hours.
Dr. Choudhury reported having no financial disclosures.
On Twitter @sherryboschert
BOSTON – Terlipressin proved noninferior to noradrenaline as a vasopressor for patients with cirrhosis and septic shock in an open-label study that randomized 84 patients.
Terlipressin also seemed to provide advantages over noradrenaline by contributing to greater hemodynamic stability, improved urine output, reduced variceal bleeding, a lower risk of spontaneous bacterial peritonitis, and reduced mortality in the first 48 hours but not at 28 days, Dr. Ashok K. Choudhury and his associates reported.
“Terlipressin is noninferior to noradrenaline as a vasopressor,” he said at the annual meeting of the American Association for the Study of Liver Diseases.
The investigators randomized consecutive, matched adults with cirrhosis and septic shock not responding to fluid resuscitation for 2 hours. They aimed to achieve a mean arterial pressure (MAP) > 65 mm Hg at 6 hours by treating 42 patients with a continuous infusion of terlipressin 1.3-5.2 mcg/min, stepped up every 15 minutes, and 42 patients with noradrenaline 7.5-6 mcg/min, stepped up every 15 minutes. Both groups received standard medical care of intravenous fluids, antibiotics, and ICU care.
The target MAP was reached within 6 hours in 28 patients on terlipressin (67%) and 23 patients on noradrenaline (55%), a difference that was not statistically significant, said Dr. Choudhury of the Institute of Liver and Biliary Sciences, New Delhi. He won a research award from the Association.
Patients in the two groups were matched by age, sex, etiology and severity of cirrhosis, and scores on the Model for End-Stage Liver Disease and the Sequential Organ Failure Assessment.
Spontaneous bacterial peritonitis was the main cause of sepsis at admission, followed by pneumonia, but pneumonia was the main cause of “second hit” pneumonia, he said.
Terlipressin therapy was associated with a lower failure rate at 6 hours, a greater likelihood of MAP maintenance with cessation of vasopressor requirements at 48 hours, and improved urine output at 24 hours, compared with noradrenaline treatment. At 48 hours, 19 of 40 patients on terlipressin (48%) and 11 of 30 patients on noradrenaline (36%) had an MAP > 65 mm Hg.
No patients on terlipressin developed a variceal bleed, compared with seven patients in the noradrenaline group (10%). Overall rates of adverse events did not differ significantly between groups, but were higher in the terlipressin group than in the noradrenaline group.
Better rates of lactate clearance, central venous oxygen saturation, and carbon dioxide gradient in venous-arterial blood gases in the terlipressin group were not statistically different from rates in the noradrenaline group.
Significantly more patients on terlipressin survived the first 48 hours than patients on noradrenaline, but by day 28 of follow-up survival rates did not differ significantly between groups.
On the whole, septic shock in these patients with cirrhosis was associated with a high mortality rate (80%). Twelve percent of patients were responsive to fluids in 2 hours.
Dr. Choudhury reported having no financial disclosures.
On Twitter @sherryboschert
BOSTON – Terlipressin proved noninferior to noradrenaline as a vasopressor for patients with cirrhosis and septic shock in an open-label study that randomized 84 patients.
Terlipressin also seemed to provide advantages over noradrenaline by contributing to greater hemodynamic stability, improved urine output, reduced variceal bleeding, a lower risk of spontaneous bacterial peritonitis, and reduced mortality in the first 48 hours but not at 28 days, Dr. Ashok K. Choudhury and his associates reported.
“Terlipressin is noninferior to noradrenaline as a vasopressor,” he said at the annual meeting of the American Association for the Study of Liver Diseases.
The investigators randomized consecutive, matched adults with cirrhosis and septic shock not responding to fluid resuscitation for 2 hours. They aimed to achieve a mean arterial pressure (MAP) > 65 mm Hg at 6 hours by treating 42 patients with a continuous infusion of terlipressin 1.3-5.2 mcg/min, stepped up every 15 minutes, and 42 patients with noradrenaline 7.5-6 mcg/min, stepped up every 15 minutes. Both groups received standard medical care of intravenous fluids, antibiotics, and ICU care.
The target MAP was reached within 6 hours in 28 patients on terlipressin (67%) and 23 patients on noradrenaline (55%), a difference that was not statistically significant, said Dr. Choudhury of the Institute of Liver and Biliary Sciences, New Delhi. He won a research award from the Association.
Patients in the two groups were matched by age, sex, etiology and severity of cirrhosis, and scores on the Model for End-Stage Liver Disease and the Sequential Organ Failure Assessment.
Spontaneous bacterial peritonitis was the main cause of sepsis at admission, followed by pneumonia, but pneumonia was the main cause of “second hit” pneumonia, he said.
Terlipressin therapy was associated with a lower failure rate at 6 hours, a greater likelihood of MAP maintenance with cessation of vasopressor requirements at 48 hours, and improved urine output at 24 hours, compared with noradrenaline treatment. At 48 hours, 19 of 40 patients on terlipressin (48%) and 11 of 30 patients on noradrenaline (36%) had an MAP > 65 mm Hg.
No patients on terlipressin developed a variceal bleed, compared with seven patients in the noradrenaline group (10%). Overall rates of adverse events did not differ significantly between groups, but were higher in the terlipressin group than in the noradrenaline group.
Better rates of lactate clearance, central venous oxygen saturation, and carbon dioxide gradient in venous-arterial blood gases in the terlipressin group were not statistically different from rates in the noradrenaline group.
Significantly more patients on terlipressin survived the first 48 hours than patients on noradrenaline, but by day 28 of follow-up survival rates did not differ significantly between groups.
On the whole, septic shock in these patients with cirrhosis was associated with a high mortality rate (80%). Twelve percent of patients were responsive to fluids in 2 hours.
Dr. Choudhury reported having no financial disclosures.
On Twitter @sherryboschert
AT THE LIVER MEETING 2014
Key clinical point: Terlipressin worked as well as noradrenaline as a vasopressor.
Major finding: Treatment achieved a MAP of >65 mm Hg by 6 hours in 28 patients on terlipressin (67%) and in 23 patients on noradrenaline (55%).
Data source: A prospective, randomized, open-label study of 84 patients with cirrhosis and septic shock.
Disclosures: Dr. Choudhury reported having no financial disclosures.
CT overutilized to diagnose appendicitis
SAN FRANCISCO – At least 25% of CT scans to diagnose appendicitis were unnecessary, potentially resulting in $1.8 million in costs at one institution and up to four new cancers from the radiation exposure, a retrospective study suggests.
The review of 1,054 patients who underwent appendectomy at the University of California, Davis, in 2005-2010 focused on costs for the patients who had high Alvarado scores, a clinical scoring system used to diagnose appendicitis, before they underwent appendectomy. CT scans to help diagnose appendicitis were performed on 77% of all patients.
Records showed that 26% of patients had an Alvarado score of 8-10, meaning that appendicitis was highly likely. CT was performed on 70% of patients with an Alvarado score of 8 and 77% of patients with a score of 9-10, comprising nearly 25% of all CT scans. That resulted in an estimated $1,813,399 in unnecessary costs for imaging, Dr. Adam Dougherty and his associates reported at the annual clinical congress of the American College of Surgeons.
This “overutilization” of CT scans delivered more than 4,009 mSv in unnecessary radiation exposure, averaging 19.75 mSV per scan, which is 20 times the annual limit suggested for safety, said Dr. Dougherty of the university. That excess radiation could be expected to produce up to four new cancers down the line, resulting in additional costs, he said.
The investigators also looked at the 9% of patients with low Alvarado scores, meaning that appendicitis was unlikely. CT scans were performed in 75% of patients with a score of 0-3 and 80% of patients with an Alvarado score of 4. In this subgroup, 24% showed normal/early pathology on appendectomy, which “argues against imaging and surgical treatment,” Dr. Dougherty said. The 44 CT scans in this subgroup resulted in an estimated $393,052 in unnecessary costs, he said.
That doesn’t include additional costs that could be expected from imaging, such as wait time, appendectomy and its sequelae, and potential workups of incidentalomas in the low-risk group, he added.
Previous studies have shown that a comprehensive clinical exam is as accurate as CT in diagnosing appendicitis, and that clinical assessment unaided by CT can reliably diagnose acute appendicitis, Dr. Dougherty said.
With a 72% increase in abdominal CT scans documented in other U.S. data from 2000 to 2005, he called for a “necessary, fundamental culture change” to restrain resource utilization “in order to maximize the value of the health care dollar while doing what is best for the patient.”
The investigators proposed a clinical pathway for the workup of suspected appendicitis that places greater emphasis on ultrasound imaging and conservative pathways, such as 23-hour admission for observation and next-day follow-up.
In the study, ultrasonography was underutilized across all subgroups as a viable alternative to CT scans, he said.
Dr. Dougherty reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – At least 25% of CT scans to diagnose appendicitis were unnecessary, potentially resulting in $1.8 million in costs at one institution and up to four new cancers from the radiation exposure, a retrospective study suggests.
The review of 1,054 patients who underwent appendectomy at the University of California, Davis, in 2005-2010 focused on costs for the patients who had high Alvarado scores, a clinical scoring system used to diagnose appendicitis, before they underwent appendectomy. CT scans to help diagnose appendicitis were performed on 77% of all patients.
Records showed that 26% of patients had an Alvarado score of 8-10, meaning that appendicitis was highly likely. CT was performed on 70% of patients with an Alvarado score of 8 and 77% of patients with a score of 9-10, comprising nearly 25% of all CT scans. That resulted in an estimated $1,813,399 in unnecessary costs for imaging, Dr. Adam Dougherty and his associates reported at the annual clinical congress of the American College of Surgeons.
This “overutilization” of CT scans delivered more than 4,009 mSv in unnecessary radiation exposure, averaging 19.75 mSV per scan, which is 20 times the annual limit suggested for safety, said Dr. Dougherty of the university. That excess radiation could be expected to produce up to four new cancers down the line, resulting in additional costs, he said.
The investigators also looked at the 9% of patients with low Alvarado scores, meaning that appendicitis was unlikely. CT scans were performed in 75% of patients with a score of 0-3 and 80% of patients with an Alvarado score of 4. In this subgroup, 24% showed normal/early pathology on appendectomy, which “argues against imaging and surgical treatment,” Dr. Dougherty said. The 44 CT scans in this subgroup resulted in an estimated $393,052 in unnecessary costs, he said.
That doesn’t include additional costs that could be expected from imaging, such as wait time, appendectomy and its sequelae, and potential workups of incidentalomas in the low-risk group, he added.
Previous studies have shown that a comprehensive clinical exam is as accurate as CT in diagnosing appendicitis, and that clinical assessment unaided by CT can reliably diagnose acute appendicitis, Dr. Dougherty said.
With a 72% increase in abdominal CT scans documented in other U.S. data from 2000 to 2005, he called for a “necessary, fundamental culture change” to restrain resource utilization “in order to maximize the value of the health care dollar while doing what is best for the patient.”
The investigators proposed a clinical pathway for the workup of suspected appendicitis that places greater emphasis on ultrasound imaging and conservative pathways, such as 23-hour admission for observation and next-day follow-up.
In the study, ultrasonography was underutilized across all subgroups as a viable alternative to CT scans, he said.
Dr. Dougherty reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – At least 25% of CT scans to diagnose appendicitis were unnecessary, potentially resulting in $1.8 million in costs at one institution and up to four new cancers from the radiation exposure, a retrospective study suggests.
The review of 1,054 patients who underwent appendectomy at the University of California, Davis, in 2005-2010 focused on costs for the patients who had high Alvarado scores, a clinical scoring system used to diagnose appendicitis, before they underwent appendectomy. CT scans to help diagnose appendicitis were performed on 77% of all patients.
Records showed that 26% of patients had an Alvarado score of 8-10, meaning that appendicitis was highly likely. CT was performed on 70% of patients with an Alvarado score of 8 and 77% of patients with a score of 9-10, comprising nearly 25% of all CT scans. That resulted in an estimated $1,813,399 in unnecessary costs for imaging, Dr. Adam Dougherty and his associates reported at the annual clinical congress of the American College of Surgeons.
This “overutilization” of CT scans delivered more than 4,009 mSv in unnecessary radiation exposure, averaging 19.75 mSV per scan, which is 20 times the annual limit suggested for safety, said Dr. Dougherty of the university. That excess radiation could be expected to produce up to four new cancers down the line, resulting in additional costs, he said.
The investigators also looked at the 9% of patients with low Alvarado scores, meaning that appendicitis was unlikely. CT scans were performed in 75% of patients with a score of 0-3 and 80% of patients with an Alvarado score of 4. In this subgroup, 24% showed normal/early pathology on appendectomy, which “argues against imaging and surgical treatment,” Dr. Dougherty said. The 44 CT scans in this subgroup resulted in an estimated $393,052 in unnecessary costs, he said.
That doesn’t include additional costs that could be expected from imaging, such as wait time, appendectomy and its sequelae, and potential workups of incidentalomas in the low-risk group, he added.
Previous studies have shown that a comprehensive clinical exam is as accurate as CT in diagnosing appendicitis, and that clinical assessment unaided by CT can reliably diagnose acute appendicitis, Dr. Dougherty said.
With a 72% increase in abdominal CT scans documented in other U.S. data from 2000 to 2005, he called for a “necessary, fundamental culture change” to restrain resource utilization “in order to maximize the value of the health care dollar while doing what is best for the patient.”
The investigators proposed a clinical pathway for the workup of suspected appendicitis that places greater emphasis on ultrasound imaging and conservative pathways, such as 23-hour admission for observation and next-day follow-up.
In the study, ultrasonography was underutilized across all subgroups as a viable alternative to CT scans, he said.
Dr. Dougherty reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ACS CLINICAL CONGRESS
Key clinical point: Records showed that 26% of patients who had CT scans for suspect appendicitis had an Alvarado score of 8-10.
Major finding: A quarter of CT scans were on patients with likely appendicitis by Alvarado score, producing $1.8 million in unnecessary costs.
Data source: A retrospective study of 1,054 patients undergoing appendectomy in 2005-2010 at one institution.
Disclosures: Dr. Dougherty reported having no financial disclosures.
Corticosteroids didn’t help pediatric septic shock
SAN FRANCISCO – Adjunctive corticosteroid therapy for pediatric septic shock was associated with increased risks for a complicated course or death within 28 days in a retrospective study of data on 496 patients.
The investigators hypothesized that any potential benefit from adjunctive corticosteroids might depend on the patient’s initial risk of death, but they found no significant differences in outcomes between subgroups of patients that were rated as low risk, intermediate risk, or high risk at baseline using the Pediatric Sepsis Biomarker Risk Model (PERSEVERE) and received corticosteroids.
Among the 252 patients who received corticosteroids, 17% died within 38 days and 32% had a complicated course, defined as persistence of two or more organ failures at day 7 of septic shock or death within 28 days. Those rates were significantly higher than among the 244 patients who did not get corticosteroids, 8% of whom died within 28 days and 22% of whom had a complicated course, Dr. Sarah J. Atkinson and her associates reported.
The PERSEVERE-based mortality probability at baseline did not differ significantly between patients who did or did not get corticosteroids, though those who got corticosteroids had higher risk scores at baseline when assessed using the Pediatric Risk of Mortality score (PRISM).
Patients who got corticosteroids were twice as likely to die and nearly twice as likely to have a complicated course, compared with the no-corticosteroid group, she said at the annual clinical congress of the American College of Surgeons. The risks of death or complicated course did not differ significantly based on steroid use, however, in the 323 patients deemed to be low risk, the 117 intermediate-risk patients, or the 56 high-risk patients as rated by PERSEVERE. “Even in high-risk patients, the sickest patients, we do not even see a trend for benefit” from the use of corticosteroids, she said.
Because the corticosteroid group had a higher rate of comorbidity (42%), compared with the no-corticosteroid group (29%), the investigators conducted a sensitivity analysis of data on a subset of 321 patients without any comorbidities. Steroid use was associated with a 2.6 odds ratio for dying within 28 days and a doubling in odds for a complicated course, reported Dr. Atkinson of the University of Cincinnati.
“Risk-stratified analysis failed to demonstrate any benefit associated with corticosteroid use as adjunctive therapy for pediatric septic shock and suggests the possibility for harm in some patients,” Dr. Atkinson said. A randomized, controlled trial would be needed to identify any efficacy of corticosteroids as adjunct therapy in children with septic shock, she added.
Use of steroids in septic shock remains heavily debated, with no consensus and varying practices among physicians, she said. The 2012 update of Surviving Sepsis guidelines suggests “timely hydrocortisone therapy in children with fluid-refractory, catecholamine-resistant shock and suspected or proven absolute [classic] adrenal insufficiency,” Dr. Atkinson noted.
The current study analyzed data from a database of 27 pediatric centers on children who received corticosteroids within 7 days of ICU admission. In the corticosteroid group, 79% received hydrocortisone, 15% got methylprednisolone, and 6% received dexamethasone. Fluticasone, budesonide, or less than 48 hours of dexamethasone were classified as no steroids. Corticosteroids were administered for a median of 5 days starting on the day patients met criteria for septic shock.
Dr. Atkinson reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Adjunctive corticosteroid therapy for pediatric septic shock was associated with increased risks for a complicated course or death within 28 days in a retrospective study of data on 496 patients.
The investigators hypothesized that any potential benefit from adjunctive corticosteroids might depend on the patient’s initial risk of death, but they found no significant differences in outcomes between subgroups of patients that were rated as low risk, intermediate risk, or high risk at baseline using the Pediatric Sepsis Biomarker Risk Model (PERSEVERE) and received corticosteroids.
Among the 252 patients who received corticosteroids, 17% died within 38 days and 32% had a complicated course, defined as persistence of two or more organ failures at day 7 of septic shock or death within 28 days. Those rates were significantly higher than among the 244 patients who did not get corticosteroids, 8% of whom died within 28 days and 22% of whom had a complicated course, Dr. Sarah J. Atkinson and her associates reported.
The PERSEVERE-based mortality probability at baseline did not differ significantly between patients who did or did not get corticosteroids, though those who got corticosteroids had higher risk scores at baseline when assessed using the Pediatric Risk of Mortality score (PRISM).
Patients who got corticosteroids were twice as likely to die and nearly twice as likely to have a complicated course, compared with the no-corticosteroid group, she said at the annual clinical congress of the American College of Surgeons. The risks of death or complicated course did not differ significantly based on steroid use, however, in the 323 patients deemed to be low risk, the 117 intermediate-risk patients, or the 56 high-risk patients as rated by PERSEVERE. “Even in high-risk patients, the sickest patients, we do not even see a trend for benefit” from the use of corticosteroids, she said.
Because the corticosteroid group had a higher rate of comorbidity (42%), compared with the no-corticosteroid group (29%), the investigators conducted a sensitivity analysis of data on a subset of 321 patients without any comorbidities. Steroid use was associated with a 2.6 odds ratio for dying within 28 days and a doubling in odds for a complicated course, reported Dr. Atkinson of the University of Cincinnati.
“Risk-stratified analysis failed to demonstrate any benefit associated with corticosteroid use as adjunctive therapy for pediatric septic shock and suggests the possibility for harm in some patients,” Dr. Atkinson said. A randomized, controlled trial would be needed to identify any efficacy of corticosteroids as adjunct therapy in children with septic shock, she added.
Use of steroids in septic shock remains heavily debated, with no consensus and varying practices among physicians, she said. The 2012 update of Surviving Sepsis guidelines suggests “timely hydrocortisone therapy in children with fluid-refractory, catecholamine-resistant shock and suspected or proven absolute [classic] adrenal insufficiency,” Dr. Atkinson noted.
The current study analyzed data from a database of 27 pediatric centers on children who received corticosteroids within 7 days of ICU admission. In the corticosteroid group, 79% received hydrocortisone, 15% got methylprednisolone, and 6% received dexamethasone. Fluticasone, budesonide, or less than 48 hours of dexamethasone were classified as no steroids. Corticosteroids were administered for a median of 5 days starting on the day patients met criteria for septic shock.
Dr. Atkinson reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Adjunctive corticosteroid therapy for pediatric septic shock was associated with increased risks for a complicated course or death within 28 days in a retrospective study of data on 496 patients.
The investigators hypothesized that any potential benefit from adjunctive corticosteroids might depend on the patient’s initial risk of death, but they found no significant differences in outcomes between subgroups of patients that were rated as low risk, intermediate risk, or high risk at baseline using the Pediatric Sepsis Biomarker Risk Model (PERSEVERE) and received corticosteroids.
Among the 252 patients who received corticosteroids, 17% died within 38 days and 32% had a complicated course, defined as persistence of two or more organ failures at day 7 of septic shock or death within 28 days. Those rates were significantly higher than among the 244 patients who did not get corticosteroids, 8% of whom died within 28 days and 22% of whom had a complicated course, Dr. Sarah J. Atkinson and her associates reported.
The PERSEVERE-based mortality probability at baseline did not differ significantly between patients who did or did not get corticosteroids, though those who got corticosteroids had higher risk scores at baseline when assessed using the Pediatric Risk of Mortality score (PRISM).
Patients who got corticosteroids were twice as likely to die and nearly twice as likely to have a complicated course, compared with the no-corticosteroid group, she said at the annual clinical congress of the American College of Surgeons. The risks of death or complicated course did not differ significantly based on steroid use, however, in the 323 patients deemed to be low risk, the 117 intermediate-risk patients, or the 56 high-risk patients as rated by PERSEVERE. “Even in high-risk patients, the sickest patients, we do not even see a trend for benefit” from the use of corticosteroids, she said.
Because the corticosteroid group had a higher rate of comorbidity (42%), compared with the no-corticosteroid group (29%), the investigators conducted a sensitivity analysis of data on a subset of 321 patients without any comorbidities. Steroid use was associated with a 2.6 odds ratio for dying within 28 days and a doubling in odds for a complicated course, reported Dr. Atkinson of the University of Cincinnati.
“Risk-stratified analysis failed to demonstrate any benefit associated with corticosteroid use as adjunctive therapy for pediatric septic shock and suggests the possibility for harm in some patients,” Dr. Atkinson said. A randomized, controlled trial would be needed to identify any efficacy of corticosteroids as adjunct therapy in children with septic shock, she added.
Use of steroids in septic shock remains heavily debated, with no consensus and varying practices among physicians, she said. The 2012 update of Surviving Sepsis guidelines suggests “timely hydrocortisone therapy in children with fluid-refractory, catecholamine-resistant shock and suspected or proven absolute [classic] adrenal insufficiency,” Dr. Atkinson noted.
The current study analyzed data from a database of 27 pediatric centers on children who received corticosteroids within 7 days of ICU admission. In the corticosteroid group, 79% received hydrocortisone, 15% got methylprednisolone, and 6% received dexamethasone. Fluticasone, budesonide, or less than 48 hours of dexamethasone were classified as no steroids. Corticosteroids were administered for a median of 5 days starting on the day patients met criteria for septic shock.
Dr. Atkinson reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ACS CLINICAL CONGRESS
Key clinical point: Adjunctive corticosteroid therapy didn’t offer benefits to pediatric patients with septic shock, regardless of initial mortality risk.
Major finding: With steroids, 17% died and 32% had a complicated course, versus 8% and 22% without steroids, respectively.
Data source: A retrospective analysis of multicenter data on 496 cases of pediatric septic shock.
Disclosures: Dr. Atkinson reported having no financial disclosures.
Nonoperative management okay after draining diverticular-associated abscess
SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.
Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.
Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.
“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”
All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.
Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.
For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m2, and 52% were female.
The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.
An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.
The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).
Dr. Jalouta reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.
Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.
Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.
“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”
All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.
Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.
For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m2, and 52% were female.
The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.
An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.
The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).
Dr. Jalouta reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.
Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.
Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.
“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”
All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.
Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.
For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m2, and 52% were female.
The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.
An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.
The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).
Dr. Jalouta reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ACS CLINICAL CONGRESS
Key clinical point: Patients can do well without elective surgical resection following successful percutaneous drainage of diverticular-associated abscess.
Major finding: No recurrent diverticulitis was seen at 5 years in 37 of 52 patients who did not have surgery.
Data source: A retrospective review of all 165 patients who underwent percutaneous drainage of diverticular-associated abscesses in 12 years at two hospitals.
Disclosures: Dr. Jalouta reported having no financial disclosures.
VIDEO: Mortality rate after elective colorectal surgery hits 2%
SAN FRANCISCO– Patients undergoing elective colorectal surgery had an overall mortality rate of 1.7% after 30 days, an analysis of data from 65,716 patients showed.
Patients with significant preoperative morbidity had a significantly higher risk of dying after the surgery, Dr. Alodia Gabre-Kidan and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview, Dr. Gabre-Kidan discusses the results of the retrospective study, including the especially high risk for patients with preoperative renal failure or heart failure. The findings should help clinicians better counsel patients who are considering elective colorectal surgery, said Dr. Gabre-Kidan of Columbia University, New York.
Dr. Gabre-Kidan reporting having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO– Patients undergoing elective colorectal surgery had an overall mortality rate of 1.7% after 30 days, an analysis of data from 65,716 patients showed.
Patients with significant preoperative morbidity had a significantly higher risk of dying after the surgery, Dr. Alodia Gabre-Kidan and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview, Dr. Gabre-Kidan discusses the results of the retrospective study, including the especially high risk for patients with preoperative renal failure or heart failure. The findings should help clinicians better counsel patients who are considering elective colorectal surgery, said Dr. Gabre-Kidan of Columbia University, New York.
Dr. Gabre-Kidan reporting having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO– Patients undergoing elective colorectal surgery had an overall mortality rate of 1.7% after 30 days, an analysis of data from 65,716 patients showed.
Patients with significant preoperative morbidity had a significantly higher risk of dying after the surgery, Dr. Alodia Gabre-Kidan and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview, Dr. Gabre-Kidan discusses the results of the retrospective study, including the especially high risk for patients with preoperative renal failure or heart failure. The findings should help clinicians better counsel patients who are considering elective colorectal surgery, said Dr. Gabre-Kidan of Columbia University, New York.
Dr. Gabre-Kidan reporting having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ACS CLINICAL CONGRESS
Perioperative fluid levels increase ileus risk
SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.
Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.
“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”
Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.
The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.
Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.
Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.
Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.
Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.
The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.
Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
On Twitter @sherryboschert
SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.
Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.
“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”
Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.
The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.
Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.
Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.
Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.
Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.
The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.
Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
On Twitter @sherryboschert
SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.
Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.
“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”
Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.
The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.
Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.
Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.
Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.
Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.
The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.
Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
On Twitter @sherryboschert
AT THE ACS CLINICAL CONGRESS
Key clinical point: Giving no more than 1.7 liters or more than 5 liters of IV fluids on the day of surgery increased the risk of ileus.
Major finding: The ileus risk was 10% higher with excessive IV fluids and 12% higher with low fluids.
Data source: A retrospective observational cohort study of data on 84,722 patients undergoing colon surgery.
Disclosures: Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
