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Value-based care news abounds at ACEP18
The answer is none.
The question (for $1,000, Alex) is how many of the dozens of proposals to create physician-focused alternative payment models (APMs) have been approved under the new federal Quality Payment Program?
However, ACEP’s submission, entitled the Acute Unscheduled Care Model (AUCM): Enhancing Appropriate Admissions, seems to have gotten close to a nod when federal health care leaders showed up at a recent meeting on the model.
Reviewers from the Physician-Focused Payment Model Technical Advisory Committee “thought that we met all 10 criteria for models that the secretary put forth for evaluating physician-focused payment models,” Jeffrey Davis, ACEP director of regulatory affairs, said in an interview, adding that the attendance at the meeting of Alex Azar, secretary of Health & Human Serviecs, and Seema Verma, administrator of the Centers for Medicare & Medicaid Services, was a positive development.
To read our full story, check out the link below.
Key sessions at ACEP18 on QPP, MACRA, APMs, and MIPS include:
MO-058 Goodbye SGR! Hello MACRA and MIPS
Monday, Oct. 1 | 1:30 PM
TU-131 FAST FACTS: Reimbursement Topics for the Practicing Emergency Physician
Tuesday, Oct. 2 | 10:00 AM
TU-187 Alternative Payment Models: The New Reimbursement Frontier
Tuesday, Oct. 2 | 4:00 PM
The answer is none.
The question (for $1,000, Alex) is how many of the dozens of proposals to create physician-focused alternative payment models (APMs) have been approved under the new federal Quality Payment Program?
However, ACEP’s submission, entitled the Acute Unscheduled Care Model (AUCM): Enhancing Appropriate Admissions, seems to have gotten close to a nod when federal health care leaders showed up at a recent meeting on the model.
Reviewers from the Physician-Focused Payment Model Technical Advisory Committee “thought that we met all 10 criteria for models that the secretary put forth for evaluating physician-focused payment models,” Jeffrey Davis, ACEP director of regulatory affairs, said in an interview, adding that the attendance at the meeting of Alex Azar, secretary of Health & Human Serviecs, and Seema Verma, administrator of the Centers for Medicare & Medicaid Services, was a positive development.
To read our full story, check out the link below.
Key sessions at ACEP18 on QPP, MACRA, APMs, and MIPS include:
MO-058 Goodbye SGR! Hello MACRA and MIPS
Monday, Oct. 1 | 1:30 PM
TU-131 FAST FACTS: Reimbursement Topics for the Practicing Emergency Physician
Tuesday, Oct. 2 | 10:00 AM
TU-187 Alternative Payment Models: The New Reimbursement Frontier
Tuesday, Oct. 2 | 4:00 PM
The answer is none.
The question (for $1,000, Alex) is how many of the dozens of proposals to create physician-focused alternative payment models (APMs) have been approved under the new federal Quality Payment Program?
However, ACEP’s submission, entitled the Acute Unscheduled Care Model (AUCM): Enhancing Appropriate Admissions, seems to have gotten close to a nod when federal health care leaders showed up at a recent meeting on the model.
Reviewers from the Physician-Focused Payment Model Technical Advisory Committee “thought that we met all 10 criteria for models that the secretary put forth for evaluating physician-focused payment models,” Jeffrey Davis, ACEP director of regulatory affairs, said in an interview, adding that the attendance at the meeting of Alex Azar, secretary of Health & Human Serviecs, and Seema Verma, administrator of the Centers for Medicare & Medicaid Services, was a positive development.
To read our full story, check out the link below.
Key sessions at ACEP18 on QPP, MACRA, APMs, and MIPS include:
MO-058 Goodbye SGR! Hello MACRA and MIPS
Monday, Oct. 1 | 1:30 PM
TU-131 FAST FACTS: Reimbursement Topics for the Practicing Emergency Physician
Tuesday, Oct. 2 | 10:00 AM
TU-187 Alternative Payment Models: The New Reimbursement Frontier
Tuesday, Oct. 2 | 4:00 PM
REPORTING FROM ACEP18
ICYMI: Fingolimod effective in pediatric relapsing multiple sclerosis
Fingolimod reduced the rate of relapse as well as the deposition of lesions on MRI better than interferon beta-1a did over 2 years in pediatric patients with relapsing multiple sclerosis, according to the results of the PARADIGMS trial, published online Sept. 12 in the New England Journal of Medicine (2018; 379:1017-27. doi: 10.1056/NEJMoa1800149). More serious adverse events were seen in fingolimod-treated patients.
We covered the story before it was published in the journal. Find our conference coverage at the links below.
Fingolimod reduced the rate of relapse as well as the deposition of lesions on MRI better than interferon beta-1a did over 2 years in pediatric patients with relapsing multiple sclerosis, according to the results of the PARADIGMS trial, published online Sept. 12 in the New England Journal of Medicine (2018; 379:1017-27. doi: 10.1056/NEJMoa1800149). More serious adverse events were seen in fingolimod-treated patients.
We covered the story before it was published in the journal. Find our conference coverage at the links below.
Fingolimod reduced the rate of relapse as well as the deposition of lesions on MRI better than interferon beta-1a did over 2 years in pediatric patients with relapsing multiple sclerosis, according to the results of the PARADIGMS trial, published online Sept. 12 in the New England Journal of Medicine (2018; 379:1017-27. doi: 10.1056/NEJMoa1800149). More serious adverse events were seen in fingolimod-treated patients.
We covered the story before it was published in the journal. Find our conference coverage at the links below.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
VIDEO: Office-based hereditary cancer risk testing is doable
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
REPORTING FROM ACOG 2018
Key clinical point: Ob.gyns. can successfully integrate hereditary cancer risk testing into their practices.
Major finding: Office-based genetic testing increased from 1% to 4% of patients seen.
Study details: Prospective, single-arm process intervention study screening more than 4,000 women at 5 ob.gyn. practice sites.
Disclosures: Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors included employees of Myriad Genetics, some with ownership interests.
Source: DeFrancesco, MS et al. ACOG 2018 poster 3K.
LARC uptake surged immediately after Trump’s election
AUSTIN, TEXAS – , as compared with the same time period 1 year earlier, Aparna Sridhar, MD, reported.
Mr. Trump’s campaign promise to repeal and replace the Affordable Care Act in the first 100 days of his presidency sparked concern in many young women that they would lose access to copay-free contraception. Therefore, based on news reports and data released by insurer AthenaHealth that noted a 19% increase in IUD insertion nationally between October and December 2016, Dr. Sridhar and her colleagues at the University of California, Los Angeles, retrospectively reviewed data on students requesting insertion of a long-acting contraceptive (LARC) at the university’s student health center in the 2 months before and after the 2016 presidential election.
In the 8 weeks prior to the November election, the UCLA doctors inserted 53 LARCs, the majority of which were levonorgestrel-releasing intrauterine systems. In the 8 weeks after the election, that number jumped to 118 insertions, a 123% increase (P = .02), again with a preponderance of hormonal IUDs. There was no statistically significant difference in insertions in the same 2 time periods in 2015, said Dr. Sridhar, of the UCLA department of obstetrics and gynecology.
The investigators also looked at whether the increase they saw could be related to the common year-end practice of maximizing health insurance benefits and found a significant increase in LARC insertions from 2015 to 2016, she added.
She noted that the team continues to monitor LARC insertions to look for additional behavior patterns.
Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
SOURCE: Sridhar, A et al. ACOG poster presentation.
AUSTIN, TEXAS – , as compared with the same time period 1 year earlier, Aparna Sridhar, MD, reported.
Mr. Trump’s campaign promise to repeal and replace the Affordable Care Act in the first 100 days of his presidency sparked concern in many young women that they would lose access to copay-free contraception. Therefore, based on news reports and data released by insurer AthenaHealth that noted a 19% increase in IUD insertion nationally between October and December 2016, Dr. Sridhar and her colleagues at the University of California, Los Angeles, retrospectively reviewed data on students requesting insertion of a long-acting contraceptive (LARC) at the university’s student health center in the 2 months before and after the 2016 presidential election.
In the 8 weeks prior to the November election, the UCLA doctors inserted 53 LARCs, the majority of which were levonorgestrel-releasing intrauterine systems. In the 8 weeks after the election, that number jumped to 118 insertions, a 123% increase (P = .02), again with a preponderance of hormonal IUDs. There was no statistically significant difference in insertions in the same 2 time periods in 2015, said Dr. Sridhar, of the UCLA department of obstetrics and gynecology.
The investigators also looked at whether the increase they saw could be related to the common year-end practice of maximizing health insurance benefits and found a significant increase in LARC insertions from 2015 to 2016, she added.
She noted that the team continues to monitor LARC insertions to look for additional behavior patterns.
Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
SOURCE: Sridhar, A et al. ACOG poster presentation.
AUSTIN, TEXAS – , as compared with the same time period 1 year earlier, Aparna Sridhar, MD, reported.
Mr. Trump’s campaign promise to repeal and replace the Affordable Care Act in the first 100 days of his presidency sparked concern in many young women that they would lose access to copay-free contraception. Therefore, based on news reports and data released by insurer AthenaHealth that noted a 19% increase in IUD insertion nationally between October and December 2016, Dr. Sridhar and her colleagues at the University of California, Los Angeles, retrospectively reviewed data on students requesting insertion of a long-acting contraceptive (LARC) at the university’s student health center in the 2 months before and after the 2016 presidential election.
In the 8 weeks prior to the November election, the UCLA doctors inserted 53 LARCs, the majority of which were levonorgestrel-releasing intrauterine systems. In the 8 weeks after the election, that number jumped to 118 insertions, a 123% increase (P = .02), again with a preponderance of hormonal IUDs. There was no statistically significant difference in insertions in the same 2 time periods in 2015, said Dr. Sridhar, of the UCLA department of obstetrics and gynecology.
The investigators also looked at whether the increase they saw could be related to the common year-end practice of maximizing health insurance benefits and found a significant increase in LARC insertions from 2015 to 2016, she added.
She noted that the team continues to monitor LARC insertions to look for additional behavior patterns.
Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
SOURCE: Sridhar, A et al. ACOG poster presentation.
REPORTING FROM ACOG 2018
Key clinical point: College students actively sought to maintain access to copay-free contraception.
Major finding: LARC insertions increased 123% from July 2016 to February 2017.
Study details: Retrospective review of all LARC insertions at one student health center in 2016.
Disclosures: Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
Source: Sridhar, A et al. ACOG poster presentation.
Expert argues for improving MACRA, not scrapping it
Even given the notable problems and challenges associated with Medicare’s Merit-based Incentive Payment System (MIPS), the program should be improved via pilot programs and demonstration projects, according to Gail R. Wilensky, PhD, economist and senior fellow at Project Hope and a former top health aide to President George H.W. Bush.
“Although I agree with MedPAC about the problems it has identified, I am also concerned about the commission’s proposal,” Dr. Wilensky wrote in an editorial published in the New England Journal of Medicine (doi: 10.1056/NEJMp1801673). She noted that a lack of support from major medical associations, combined with the impending midterm elections, means that it would be challenging to get a legislative fix through Congress.
Read her suggestions on how to improve MIPS in the New England Journal of Medicine.
Michael E. Nelson, MD, FCCP, comments: Dr. Wilensky made some cogent arguments as to why scrapping MIPS may not be such a good idea. In my mind, however, the final paragraph of the editorial was the most important. “Practicing physicians need make their views about the MIPS and its alternatives known to their representative medical groups and, if necessary, to their representatives in Congress as well. In the past, practicing clinicians have been woefully bad at making their voices heard. Now is a good time for that to change.” Your future is being decided without you. The squeaky wheel gets the grease.
Michael E. Nelson, MD, FCCP, comments: Dr. Wilensky made some cogent arguments as to why scrapping MIPS may not be such a good idea. In my mind, however, the final paragraph of the editorial was the most important. “Practicing physicians need make their views about the MIPS and its alternatives known to their representative medical groups and, if necessary, to their representatives in Congress as well. In the past, practicing clinicians have been woefully bad at making their voices heard. Now is a good time for that to change.” Your future is being decided without you. The squeaky wheel gets the grease.
Michael E. Nelson, MD, FCCP, comments: Dr. Wilensky made some cogent arguments as to why scrapping MIPS may not be such a good idea. In my mind, however, the final paragraph of the editorial was the most important. “Practicing physicians need make their views about the MIPS and its alternatives known to their representative medical groups and, if necessary, to their representatives in Congress as well. In the past, practicing clinicians have been woefully bad at making their voices heard. Now is a good time for that to change.” Your future is being decided without you. The squeaky wheel gets the grease.
Even given the notable problems and challenges associated with Medicare’s Merit-based Incentive Payment System (MIPS), the program should be improved via pilot programs and demonstration projects, according to Gail R. Wilensky, PhD, economist and senior fellow at Project Hope and a former top health aide to President George H.W. Bush.
“Although I agree with MedPAC about the problems it has identified, I am also concerned about the commission’s proposal,” Dr. Wilensky wrote in an editorial published in the New England Journal of Medicine (doi: 10.1056/NEJMp1801673). She noted that a lack of support from major medical associations, combined with the impending midterm elections, means that it would be challenging to get a legislative fix through Congress.
Read her suggestions on how to improve MIPS in the New England Journal of Medicine.
Even given the notable problems and challenges associated with Medicare’s Merit-based Incentive Payment System (MIPS), the program should be improved via pilot programs and demonstration projects, according to Gail R. Wilensky, PhD, economist and senior fellow at Project Hope and a former top health aide to President George H.W. Bush.
“Although I agree with MedPAC about the problems it has identified, I am also concerned about the commission’s proposal,” Dr. Wilensky wrote in an editorial published in the New England Journal of Medicine (doi: 10.1056/NEJMp1801673). She noted that a lack of support from major medical associations, combined with the impending midterm elections, means that it would be challenging to get a legislative fix through Congress.
Read her suggestions on how to improve MIPS in the New England Journal of Medicine.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Robotic hysterectomy plus mini-lap outperformed open procedure
NATIONAL HARBOR, MD. – Robotic hysterectomy combined with extraction of the uterus via mini-laparotomy led to significantly shorter lengths of stay, lower estimated blood loss, and fewer postoperative complications compared with open hysterectomy when the uterus weighed more than 250 grams.
Gynecologic surgeons are seeking ways to safely perform minimally invasive hysterectomy on patients with larger uteri in light of the 2014 Food and Drug Administration admonition regarding power morcellation. To this end, Natasha Gupta, MD, and her colleagues at the University of Tennessee, Chattanooga, retrospectively reviewed all patients with uterine sizes larger than 250 grams undergoing hysterectomy at their institution between 2012 and 2015.
“For the mini-laparotomy, the technique utilizes a customized incision connecting the two left port sites, followed by the removal of the specimen via this incision,” Dr. Gupta said at the AAGL Global Congress.
Patient factors and outcomes were compared via Student t-tests and Chi-square analysis.
Mean length of stay was significantly shorter for patients who underwent robotic hysterectomy/mini-laparotomy, at 1.4 days vs. 5.4 days for those with open hysterectomy (P = .000) as was mean estimated blood loss – 119.9 mL vs. 547.5 mL, respectively (P = .000). Postoperative complications were seen in fewer patients who underwent robotic hysterectomy/mini-laparotomy, 9 of 82 patients vs. 15 of 58 open hysterectomy patients.
Mean operative time was significantly longer in robotic hysterectomy/mini-laparotomy patients – 191.6 minutes vs. 162.8 minutes (P = .005) – but that was expected, Dr. Gupta noted. Patient factors such as hypertension, diabetes, history of spontaneous vaginal delivery and/or cesarean delivery, and body mass index, as well as uterine pathology, were not significantly different between the groups.
“Mini-laparotomy combined with minimally invasive hysterectomy is a very safe and feasible technique for tissue extraction where contained morcellation is either not preferred or not available,” Dr. Gupta said.
Dr. Gupta reported having no relevant financial conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
NATIONAL HARBOR, MD. – Robotic hysterectomy combined with extraction of the uterus via mini-laparotomy led to significantly shorter lengths of stay, lower estimated blood loss, and fewer postoperative complications compared with open hysterectomy when the uterus weighed more than 250 grams.
Gynecologic surgeons are seeking ways to safely perform minimally invasive hysterectomy on patients with larger uteri in light of the 2014 Food and Drug Administration admonition regarding power morcellation. To this end, Natasha Gupta, MD, and her colleagues at the University of Tennessee, Chattanooga, retrospectively reviewed all patients with uterine sizes larger than 250 grams undergoing hysterectomy at their institution between 2012 and 2015.
“For the mini-laparotomy, the technique utilizes a customized incision connecting the two left port sites, followed by the removal of the specimen via this incision,” Dr. Gupta said at the AAGL Global Congress.
Patient factors and outcomes were compared via Student t-tests and Chi-square analysis.
Mean length of stay was significantly shorter for patients who underwent robotic hysterectomy/mini-laparotomy, at 1.4 days vs. 5.4 days for those with open hysterectomy (P = .000) as was mean estimated blood loss – 119.9 mL vs. 547.5 mL, respectively (P = .000). Postoperative complications were seen in fewer patients who underwent robotic hysterectomy/mini-laparotomy, 9 of 82 patients vs. 15 of 58 open hysterectomy patients.
Mean operative time was significantly longer in robotic hysterectomy/mini-laparotomy patients – 191.6 minutes vs. 162.8 minutes (P = .005) – but that was expected, Dr. Gupta noted. Patient factors such as hypertension, diabetes, history of spontaneous vaginal delivery and/or cesarean delivery, and body mass index, as well as uterine pathology, were not significantly different between the groups.
“Mini-laparotomy combined with minimally invasive hysterectomy is a very safe and feasible technique for tissue extraction where contained morcellation is either not preferred or not available,” Dr. Gupta said.
Dr. Gupta reported having no relevant financial conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
NATIONAL HARBOR, MD. – Robotic hysterectomy combined with extraction of the uterus via mini-laparotomy led to significantly shorter lengths of stay, lower estimated blood loss, and fewer postoperative complications compared with open hysterectomy when the uterus weighed more than 250 grams.
Gynecologic surgeons are seeking ways to safely perform minimally invasive hysterectomy on patients with larger uteri in light of the 2014 Food and Drug Administration admonition regarding power morcellation. To this end, Natasha Gupta, MD, and her colleagues at the University of Tennessee, Chattanooga, retrospectively reviewed all patients with uterine sizes larger than 250 grams undergoing hysterectomy at their institution between 2012 and 2015.
“For the mini-laparotomy, the technique utilizes a customized incision connecting the two left port sites, followed by the removal of the specimen via this incision,” Dr. Gupta said at the AAGL Global Congress.
Patient factors and outcomes were compared via Student t-tests and Chi-square analysis.
Mean length of stay was significantly shorter for patients who underwent robotic hysterectomy/mini-laparotomy, at 1.4 days vs. 5.4 days for those with open hysterectomy (P = .000) as was mean estimated blood loss – 119.9 mL vs. 547.5 mL, respectively (P = .000). Postoperative complications were seen in fewer patients who underwent robotic hysterectomy/mini-laparotomy, 9 of 82 patients vs. 15 of 58 open hysterectomy patients.
Mean operative time was significantly longer in robotic hysterectomy/mini-laparotomy patients – 191.6 minutes vs. 162.8 minutes (P = .005) – but that was expected, Dr. Gupta noted. Patient factors such as hypertension, diabetes, history of spontaneous vaginal delivery and/or cesarean delivery, and body mass index, as well as uterine pathology, were not significantly different between the groups.
“Mini-laparotomy combined with minimally invasive hysterectomy is a very safe and feasible technique for tissue extraction where contained morcellation is either not preferred or not available,” Dr. Gupta said.
Dr. Gupta reported having no relevant financial conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
AT AAGL 2017
Key clinical point:
Major finding: Mean length of stay was 1.4 days with robotic hysterectomy/mini-laparotomy vs. 5.4 days for open hysterectomy (P = .000).
Data source: A single-center retrospective review of all hysterectomies with uteri larger than 250 grams from the period of 2012-2015.
Disclosures: The study had no outside funding. Dr. Gupta reported having no relevant conflicts of interest.
Elagolix safely offers long-term endometriosis pain relief
NATIONAL HARBOR, MD. – Elagolix, an oral gonadotropin-releasing hormone antagonist, improved dysmenorrhea and nonmenstrual pelvic pain for a year or more in women with surgically-diagnosed endometriosis in two extension studies.
Women who had participated in two pivotal, 6-month studies of elagolix were given the option to continue in an extension trial for another 6 months, Sukhbir S. Singh, MD, said at the AAGL Global Congress. He noted that “all my patients who completed the 6-month trial continued out to a year.”
Patients continued on one of two doses of elagolix – 150 mg daily or 200 mg twice a day – with the lower dose providing partial estradiol suppression and the higher dose providing nearly complete suppression.
Patients tracked their dysmenorrhea and nonmenstrual pelvic pain scores on a 4-point scale daily using an electronic pain impact diary. They were classified as being responders if they experienced reduced dysmenorrhea and nonmenstrual pelvic pain equal to or better than they had during the original trial (much or very much improved on the Patient Global Impression of Change scale).
For each dose of elagolix, rates of response seen at 6 months in the original trial were maintained at a year or longer of continuous treatment, demonstrating long-term efficacy, Dr. Singh said. The average number of analgesic pills taken per month decreased 46%-77% from baseline for all doses in the extension studies.
The most common adverse events were hot flushes, experienced by just over half (52%-55%) of women in the high-dose group and about 25%-30% of women in the lower-dose group. Severity was mild to moderate across the studies.
“The higher the dose you give, the more hot flushes you get,” said Dr. Singh, vice chair of gynecology at the University of Ottawa, Ontario. “But overall, patients often did not complain of this because they were getting pain relief as well.”
Other adverse events included headache in about 25%-30% of high-dose patients and 20% of low-dose patients, as well as nausea in about one-fifth of patients overall. Some decreases from baseline in bone mineral density were seen but there was progressive improvement upon discontinuation of elagolix, Dr. Singh noted.
Importantly, “these were patients who had endometriosis and pain, similar in makeup to groups studied by others. These studies did provide two dosing options to offer individualized approaches and pain results were controlled for use of rescue analgesia. But as extension trials, the studies are limited by having no placebo control and we did not know whether they had deep endometriosis or other pain issues,” Dr. Singh said.
Elagolix represents another treatment option for patients with endometriosis, Dr. Singh said. “One of the objections to taking currently approved [gonadotropin-releasing hormone] antagonists is that they are subcutaneous injections. Patients don’t like that – this is an oral option. It is quick to act and is rapidly reversible as well.”
Dr. Singh serves as a principal investigator and speaker for Allergan, AbbVie, and Bayer. The studies were sponsored by AbbVie.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
NATIONAL HARBOR, MD. – Elagolix, an oral gonadotropin-releasing hormone antagonist, improved dysmenorrhea and nonmenstrual pelvic pain for a year or more in women with surgically-diagnosed endometriosis in two extension studies.
Women who had participated in two pivotal, 6-month studies of elagolix were given the option to continue in an extension trial for another 6 months, Sukhbir S. Singh, MD, said at the AAGL Global Congress. He noted that “all my patients who completed the 6-month trial continued out to a year.”
Patients continued on one of two doses of elagolix – 150 mg daily or 200 mg twice a day – with the lower dose providing partial estradiol suppression and the higher dose providing nearly complete suppression.
Patients tracked their dysmenorrhea and nonmenstrual pelvic pain scores on a 4-point scale daily using an electronic pain impact diary. They were classified as being responders if they experienced reduced dysmenorrhea and nonmenstrual pelvic pain equal to or better than they had during the original trial (much or very much improved on the Patient Global Impression of Change scale).
For each dose of elagolix, rates of response seen at 6 months in the original trial were maintained at a year or longer of continuous treatment, demonstrating long-term efficacy, Dr. Singh said. The average number of analgesic pills taken per month decreased 46%-77% from baseline for all doses in the extension studies.
The most common adverse events were hot flushes, experienced by just over half (52%-55%) of women in the high-dose group and about 25%-30% of women in the lower-dose group. Severity was mild to moderate across the studies.
“The higher the dose you give, the more hot flushes you get,” said Dr. Singh, vice chair of gynecology at the University of Ottawa, Ontario. “But overall, patients often did not complain of this because they were getting pain relief as well.”
Other adverse events included headache in about 25%-30% of high-dose patients and 20% of low-dose patients, as well as nausea in about one-fifth of patients overall. Some decreases from baseline in bone mineral density were seen but there was progressive improvement upon discontinuation of elagolix, Dr. Singh noted.
Importantly, “these were patients who had endometriosis and pain, similar in makeup to groups studied by others. These studies did provide two dosing options to offer individualized approaches and pain results were controlled for use of rescue analgesia. But as extension trials, the studies are limited by having no placebo control and we did not know whether they had deep endometriosis or other pain issues,” Dr. Singh said.
Elagolix represents another treatment option for patients with endometriosis, Dr. Singh said. “One of the objections to taking currently approved [gonadotropin-releasing hormone] antagonists is that they are subcutaneous injections. Patients don’t like that – this is an oral option. It is quick to act and is rapidly reversible as well.”
Dr. Singh serves as a principal investigator and speaker for Allergan, AbbVie, and Bayer. The studies were sponsored by AbbVie.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
NATIONAL HARBOR, MD. – Elagolix, an oral gonadotropin-releasing hormone antagonist, improved dysmenorrhea and nonmenstrual pelvic pain for a year or more in women with surgically-diagnosed endometriosis in two extension studies.
Women who had participated in two pivotal, 6-month studies of elagolix were given the option to continue in an extension trial for another 6 months, Sukhbir S. Singh, MD, said at the AAGL Global Congress. He noted that “all my patients who completed the 6-month trial continued out to a year.”
Patients continued on one of two doses of elagolix – 150 mg daily or 200 mg twice a day – with the lower dose providing partial estradiol suppression and the higher dose providing nearly complete suppression.
Patients tracked their dysmenorrhea and nonmenstrual pelvic pain scores on a 4-point scale daily using an electronic pain impact diary. They were classified as being responders if they experienced reduced dysmenorrhea and nonmenstrual pelvic pain equal to or better than they had during the original trial (much or very much improved on the Patient Global Impression of Change scale).
For each dose of elagolix, rates of response seen at 6 months in the original trial were maintained at a year or longer of continuous treatment, demonstrating long-term efficacy, Dr. Singh said. The average number of analgesic pills taken per month decreased 46%-77% from baseline for all doses in the extension studies.
The most common adverse events were hot flushes, experienced by just over half (52%-55%) of women in the high-dose group and about 25%-30% of women in the lower-dose group. Severity was mild to moderate across the studies.
“The higher the dose you give, the more hot flushes you get,” said Dr. Singh, vice chair of gynecology at the University of Ottawa, Ontario. “But overall, patients often did not complain of this because they were getting pain relief as well.”
Other adverse events included headache in about 25%-30% of high-dose patients and 20% of low-dose patients, as well as nausea in about one-fifth of patients overall. Some decreases from baseline in bone mineral density were seen but there was progressive improvement upon discontinuation of elagolix, Dr. Singh noted.
Importantly, “these were patients who had endometriosis and pain, similar in makeup to groups studied by others. These studies did provide two dosing options to offer individualized approaches and pain results were controlled for use of rescue analgesia. But as extension trials, the studies are limited by having no placebo control and we did not know whether they had deep endometriosis or other pain issues,” Dr. Singh said.
Elagolix represents another treatment option for patients with endometriosis, Dr. Singh said. “One of the objections to taking currently approved [gonadotropin-releasing hormone] antagonists is that they are subcutaneous injections. Patients don’t like that – this is an oral option. It is quick to act and is rapidly reversible as well.”
Dr. Singh serves as a principal investigator and speaker for Allergan, AbbVie, and Bayer. The studies were sponsored by AbbVie.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
AT AAGL 2107
Key clinical point:
Major finding: The most common adverse event was hot flushes seen in about half of women on the higher dose of elagolix.
Data source: Two randomized extension trials of 569 women.
Disclosures: Dr. Singh serves as a principal investigator and speaker for Allergan, AbbVie, and Bayer. The studies were sponsored by AbbVie.
Clinical hepatology debrief wraps up 2017 Liver Meeting
WASHINGTON – Research into alcoholic liver disease, drug-induced liver injury, the complications of chronic liver disease, and cholestatic liver diseases were among the clinical hepatology highlights presented at the annual meeting of the American Association for the Study of Liver Diseases.
This year’s debrief was given by Kris V. Kowdley, MD, of Swedish Medical Center in Seattle.
Over a median of 1.6 years of follow-up, 27% of patients resumed alcohol consumption post transplant with a median time to alcohol of 160 days, according to Brian Lee, MD, of the University of California, San Francisco. Younger age and lack of complete acceptance of their alcoholic hepatitis diagnosis were significant predictors of alcohol use post transplant while factors such as length of abstinence, race/ethnicity, insurance status, history of illicit drug use, and history of failed rehab attempts were not. Further, heavy drinking at presentation (more than 10 drinks per day), any alcohol use post transplant, and sustained alcohol use post transplant were significant predictors of posttransplant death.
Alcoholic hepatitis now “appears to be affecting more and more younger women, who present with a higher level of acuity,” Dr. Kowdley noted. He added that, while recent advances have decreased the absolute number of hepatitis C patients with decompensated liver disease who are listed for liver transplant, “the number is increasing rapidly in alcoholic liver disease, approaching the rate of patients being listed for hepatitis C.”
Unknown ingredients in herbal and dietary supplements continue to be of concern, Dr. Kowdley noted, as highlighted by Victor J. Navarro, MD, of Einstein Healthcare Network, Philadelphia, and his colleagues at the Drug-Induced Liver Injury Network (DILIN).
Investigators collected herbal and dietary supplements from patients enrolled in the DILIN prospective study and had chemical analysis performed by an outside laboratory. Labeled contents could not be verified in over half of the supplements collected and several unlabeled hepatotoxic ingredients were identified, Dr. Navarro and colleagues found (abstract 264).
“Even though we collect the supplements and review them with the patients, it’s not clear that we even know what it is that they are taking,” Dr. Kowdley commented.
Another DILIN study, this one presented by Jawad Ahmad, MD, of the Icahn School of Medicine at Mount Sinai, New York, “provided an opportunity for pause,” Dr. Kowdley said.
Dr. Ahmad and colleagues looked at hepatitis C virus (HCV) testing in DILIN patients and were able to correlate anti-HCV test results with HCV RNA tests results in more than 95% of 1,500 patients (abstract 16). About 7% of patients were HCV positive, and 23 cases of acute hepatitis were identified (16 with anti-HCV antibodies and HCV RNA, 7 with HCV RNA alone, and none with anti-HCV antibodies alone).
“So the take-home message here for me is, even if we think the patient has drug-induced liver injury, if they have not been tested for hepatitis C, especially if in the hospitalized setting … it is important to check not only the antibody test but also the RNA test,” Dr. Kowdley said.
Finally, in children, minocycline and valproate were the most commonly indicated agents in pediatric drug-induced liver injury, according to Frank DiPaola, MD, of the University of Michigan, and colleagues, on behalf of DILIN (abstract 13).
Dr. Kowdley also highlighted a couple of studies that addressed the complications of chronic liver disease.
The ADAPT-1 and ADAPT-2 trials (abstract 217) studied the use of avatrombopag, a thrombopoietin (TPO)–receptor agonist, to reduce severe thrombocytopenia in patients with chronic liver disease. Platelet transfusion is the current standard of care to reduce the risk of bleeding during invasive procedures in these patients; currently there are no drugs approved for this indication, Dr. Kowdley said.
Avatrombopag is an oral, small molecule TPO-receptor agonist, he said. “Because it binds to a different site on the TPO receptor than endogenous TPO, the effects are additive.”
In the phase 3 ADAPT-1 and ADAPT-2, the proportion of patients who did not require platelet transfusion or any rescue procedure for bleeding was significantly less in avatrombopag-treated patients than those receiving placebo. The effect was the same for patients with a low baseline platelet count (less than 40,000 platelets per mcL) as well as those with a high baseline platelet count (between 40,000/mcL and 50,000/mcL). Further, the proportion of patients who by procedure day achieved platelet count of at least 50,000/mcL was significantly higher in patients on the study drug.
Data on lusutrombopag, another TPO-receptor agonist, was presented as a late-breaker at the meeting, with very similar results in avoiding platelet transfusion, Dr. Kowdley noted.Two abstracts (502 and 219) focused on reducing ammonia levels in hospitalized cirrhosis patients with hepatic encephalitis.
Patients in the STOP-HE trial were randomized to either physician’s choice for standard of care or standard of care plus continuous infusion of ornithine phenylacetate for up to 5 days. Patients were assigned to one of three dosing groups (20 g, 15 g, or 10 g), based on severity of underlying liver disease; those with the most severe disease received the lowest dose.
Reduction in plasma ammonia levels correlated significantly with clinical improvement. At 48 hours, meaningful clinical improvement occurred in 84% of patients on ornithine phenylacetate, compared with 58% of placebo patients, according to Robert S. Rahimi, MD, of Baylor University, Dallas, and his colleagues.
“So, this may be an option for our hepatic encephalopathy patients who are admitted to the hospital and need acute treatment,” Dr. Kowdley said.
Dr. Kowdley finished up with two studies on primary biliary cholangitis (PBC).
Carla Murillo Perez, MD, of Toronto General Hospital and her colleagues in the Global PBC Study Group investigated the role of serum bilirubin in predicting transplant-free survival in patients with PBC (abstract 70).
When serum bilirubin levels from a previous study were input into a Cox regression analysis as a cubic spline function, then adjusted for factors such as age, sex, treatment with ursodeoxycholic acid, and year of diagnosis, the investigators found that patients with serum bilirubin levels of 0.7 times the upper limit of normal had a significantly increased risk of liver transplantation or death.
“We may want to be more sensitive in looking at bilirubin levels,” Dr. Kowdley said.
Another small but notable study presented by Gideon M. Hirschfield, MD, of the University of Birmingham (England), looked into whether a lower dose of seladelpar would safely and effectively lower alkaline phosphatase (AP) levels in PBC patients. A previous study of seladelpar at 50 mg and 200 mg doses indicated the drug’s effectiveness; however, the study was stopped because of the development of grade 3 alanine aminotransferase increases in a number of patients (Lancet Gastroenterol Hepatol. 2017;2;716-26).
Dr. Hirschfield and colleagues enrolled 24 patients and randomized 12 to seladelpar 5 mg and another 12 to 10 mg. The study cohort was mostly female, with an average age of 58 years. Most were either intolerant of or inadequately treated by ursodeoxycholic acid. AP levels were reduced significantly over time in both groups; however, differences between the groups were not significant, the investigators noted.
The Liver Meeting will be held in San Francisco in 2018, taking place Nov. 9-13. Many investigators in these trials reported relevant conflicts of interest; information is available (open access) in a supplement to Hepatology.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Research into alcoholic liver disease, drug-induced liver injury, the complications of chronic liver disease, and cholestatic liver diseases were among the clinical hepatology highlights presented at the annual meeting of the American Association for the Study of Liver Diseases.
This year’s debrief was given by Kris V. Kowdley, MD, of Swedish Medical Center in Seattle.
Over a median of 1.6 years of follow-up, 27% of patients resumed alcohol consumption post transplant with a median time to alcohol of 160 days, according to Brian Lee, MD, of the University of California, San Francisco. Younger age and lack of complete acceptance of their alcoholic hepatitis diagnosis were significant predictors of alcohol use post transplant while factors such as length of abstinence, race/ethnicity, insurance status, history of illicit drug use, and history of failed rehab attempts were not. Further, heavy drinking at presentation (more than 10 drinks per day), any alcohol use post transplant, and sustained alcohol use post transplant were significant predictors of posttransplant death.
Alcoholic hepatitis now “appears to be affecting more and more younger women, who present with a higher level of acuity,” Dr. Kowdley noted. He added that, while recent advances have decreased the absolute number of hepatitis C patients with decompensated liver disease who are listed for liver transplant, “the number is increasing rapidly in alcoholic liver disease, approaching the rate of patients being listed for hepatitis C.”
Unknown ingredients in herbal and dietary supplements continue to be of concern, Dr. Kowdley noted, as highlighted by Victor J. Navarro, MD, of Einstein Healthcare Network, Philadelphia, and his colleagues at the Drug-Induced Liver Injury Network (DILIN).
Investigators collected herbal and dietary supplements from patients enrolled in the DILIN prospective study and had chemical analysis performed by an outside laboratory. Labeled contents could not be verified in over half of the supplements collected and several unlabeled hepatotoxic ingredients were identified, Dr. Navarro and colleagues found (abstract 264).
“Even though we collect the supplements and review them with the patients, it’s not clear that we even know what it is that they are taking,” Dr. Kowdley commented.
Another DILIN study, this one presented by Jawad Ahmad, MD, of the Icahn School of Medicine at Mount Sinai, New York, “provided an opportunity for pause,” Dr. Kowdley said.
Dr. Ahmad and colleagues looked at hepatitis C virus (HCV) testing in DILIN patients and were able to correlate anti-HCV test results with HCV RNA tests results in more than 95% of 1,500 patients (abstract 16). About 7% of patients were HCV positive, and 23 cases of acute hepatitis were identified (16 with anti-HCV antibodies and HCV RNA, 7 with HCV RNA alone, and none with anti-HCV antibodies alone).
“So the take-home message here for me is, even if we think the patient has drug-induced liver injury, if they have not been tested for hepatitis C, especially if in the hospitalized setting … it is important to check not only the antibody test but also the RNA test,” Dr. Kowdley said.
Finally, in children, minocycline and valproate were the most commonly indicated agents in pediatric drug-induced liver injury, according to Frank DiPaola, MD, of the University of Michigan, and colleagues, on behalf of DILIN (abstract 13).
Dr. Kowdley also highlighted a couple of studies that addressed the complications of chronic liver disease.
The ADAPT-1 and ADAPT-2 trials (abstract 217) studied the use of avatrombopag, a thrombopoietin (TPO)–receptor agonist, to reduce severe thrombocytopenia in patients with chronic liver disease. Platelet transfusion is the current standard of care to reduce the risk of bleeding during invasive procedures in these patients; currently there are no drugs approved for this indication, Dr. Kowdley said.
Avatrombopag is an oral, small molecule TPO-receptor agonist, he said. “Because it binds to a different site on the TPO receptor than endogenous TPO, the effects are additive.”
In the phase 3 ADAPT-1 and ADAPT-2, the proportion of patients who did not require platelet transfusion or any rescue procedure for bleeding was significantly less in avatrombopag-treated patients than those receiving placebo. The effect was the same for patients with a low baseline platelet count (less than 40,000 platelets per mcL) as well as those with a high baseline platelet count (between 40,000/mcL and 50,000/mcL). Further, the proportion of patients who by procedure day achieved platelet count of at least 50,000/mcL was significantly higher in patients on the study drug.
Data on lusutrombopag, another TPO-receptor agonist, was presented as a late-breaker at the meeting, with very similar results in avoiding platelet transfusion, Dr. Kowdley noted.Two abstracts (502 and 219) focused on reducing ammonia levels in hospitalized cirrhosis patients with hepatic encephalitis.
Patients in the STOP-HE trial were randomized to either physician’s choice for standard of care or standard of care plus continuous infusion of ornithine phenylacetate for up to 5 days. Patients were assigned to one of three dosing groups (20 g, 15 g, or 10 g), based on severity of underlying liver disease; those with the most severe disease received the lowest dose.
Reduction in plasma ammonia levels correlated significantly with clinical improvement. At 48 hours, meaningful clinical improvement occurred in 84% of patients on ornithine phenylacetate, compared with 58% of placebo patients, according to Robert S. Rahimi, MD, of Baylor University, Dallas, and his colleagues.
“So, this may be an option for our hepatic encephalopathy patients who are admitted to the hospital and need acute treatment,” Dr. Kowdley said.
Dr. Kowdley finished up with two studies on primary biliary cholangitis (PBC).
Carla Murillo Perez, MD, of Toronto General Hospital and her colleagues in the Global PBC Study Group investigated the role of serum bilirubin in predicting transplant-free survival in patients with PBC (abstract 70).
When serum bilirubin levels from a previous study were input into a Cox regression analysis as a cubic spline function, then adjusted for factors such as age, sex, treatment with ursodeoxycholic acid, and year of diagnosis, the investigators found that patients with serum bilirubin levels of 0.7 times the upper limit of normal had a significantly increased risk of liver transplantation or death.
“We may want to be more sensitive in looking at bilirubin levels,” Dr. Kowdley said.
Another small but notable study presented by Gideon M. Hirschfield, MD, of the University of Birmingham (England), looked into whether a lower dose of seladelpar would safely and effectively lower alkaline phosphatase (AP) levels in PBC patients. A previous study of seladelpar at 50 mg and 200 mg doses indicated the drug’s effectiveness; however, the study was stopped because of the development of grade 3 alanine aminotransferase increases in a number of patients (Lancet Gastroenterol Hepatol. 2017;2;716-26).
Dr. Hirschfield and colleagues enrolled 24 patients and randomized 12 to seladelpar 5 mg and another 12 to 10 mg. The study cohort was mostly female, with an average age of 58 years. Most were either intolerant of or inadequately treated by ursodeoxycholic acid. AP levels were reduced significantly over time in both groups; however, differences between the groups were not significant, the investigators noted.
The Liver Meeting will be held in San Francisco in 2018, taking place Nov. 9-13. Many investigators in these trials reported relevant conflicts of interest; information is available (open access) in a supplement to Hepatology.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Research into alcoholic liver disease, drug-induced liver injury, the complications of chronic liver disease, and cholestatic liver diseases were among the clinical hepatology highlights presented at the annual meeting of the American Association for the Study of Liver Diseases.
This year’s debrief was given by Kris V. Kowdley, MD, of Swedish Medical Center in Seattle.
Over a median of 1.6 years of follow-up, 27% of patients resumed alcohol consumption post transplant with a median time to alcohol of 160 days, according to Brian Lee, MD, of the University of California, San Francisco. Younger age and lack of complete acceptance of their alcoholic hepatitis diagnosis were significant predictors of alcohol use post transplant while factors such as length of abstinence, race/ethnicity, insurance status, history of illicit drug use, and history of failed rehab attempts were not. Further, heavy drinking at presentation (more than 10 drinks per day), any alcohol use post transplant, and sustained alcohol use post transplant were significant predictors of posttransplant death.
Alcoholic hepatitis now “appears to be affecting more and more younger women, who present with a higher level of acuity,” Dr. Kowdley noted. He added that, while recent advances have decreased the absolute number of hepatitis C patients with decompensated liver disease who are listed for liver transplant, “the number is increasing rapidly in alcoholic liver disease, approaching the rate of patients being listed for hepatitis C.”
Unknown ingredients in herbal and dietary supplements continue to be of concern, Dr. Kowdley noted, as highlighted by Victor J. Navarro, MD, of Einstein Healthcare Network, Philadelphia, and his colleagues at the Drug-Induced Liver Injury Network (DILIN).
Investigators collected herbal and dietary supplements from patients enrolled in the DILIN prospective study and had chemical analysis performed by an outside laboratory. Labeled contents could not be verified in over half of the supplements collected and several unlabeled hepatotoxic ingredients were identified, Dr. Navarro and colleagues found (abstract 264).
“Even though we collect the supplements and review them with the patients, it’s not clear that we even know what it is that they are taking,” Dr. Kowdley commented.
Another DILIN study, this one presented by Jawad Ahmad, MD, of the Icahn School of Medicine at Mount Sinai, New York, “provided an opportunity for pause,” Dr. Kowdley said.
Dr. Ahmad and colleagues looked at hepatitis C virus (HCV) testing in DILIN patients and were able to correlate anti-HCV test results with HCV RNA tests results in more than 95% of 1,500 patients (abstract 16). About 7% of patients were HCV positive, and 23 cases of acute hepatitis were identified (16 with anti-HCV antibodies and HCV RNA, 7 with HCV RNA alone, and none with anti-HCV antibodies alone).
“So the take-home message here for me is, even if we think the patient has drug-induced liver injury, if they have not been tested for hepatitis C, especially if in the hospitalized setting … it is important to check not only the antibody test but also the RNA test,” Dr. Kowdley said.
Finally, in children, minocycline and valproate were the most commonly indicated agents in pediatric drug-induced liver injury, according to Frank DiPaola, MD, of the University of Michigan, and colleagues, on behalf of DILIN (abstract 13).
Dr. Kowdley also highlighted a couple of studies that addressed the complications of chronic liver disease.
The ADAPT-1 and ADAPT-2 trials (abstract 217) studied the use of avatrombopag, a thrombopoietin (TPO)–receptor agonist, to reduce severe thrombocytopenia in patients with chronic liver disease. Platelet transfusion is the current standard of care to reduce the risk of bleeding during invasive procedures in these patients; currently there are no drugs approved for this indication, Dr. Kowdley said.
Avatrombopag is an oral, small molecule TPO-receptor agonist, he said. “Because it binds to a different site on the TPO receptor than endogenous TPO, the effects are additive.”
In the phase 3 ADAPT-1 and ADAPT-2, the proportion of patients who did not require platelet transfusion or any rescue procedure for bleeding was significantly less in avatrombopag-treated patients than those receiving placebo. The effect was the same for patients with a low baseline platelet count (less than 40,000 platelets per mcL) as well as those with a high baseline platelet count (between 40,000/mcL and 50,000/mcL). Further, the proportion of patients who by procedure day achieved platelet count of at least 50,000/mcL was significantly higher in patients on the study drug.
Data on lusutrombopag, another TPO-receptor agonist, was presented as a late-breaker at the meeting, with very similar results in avoiding platelet transfusion, Dr. Kowdley noted.Two abstracts (502 and 219) focused on reducing ammonia levels in hospitalized cirrhosis patients with hepatic encephalitis.
Patients in the STOP-HE trial were randomized to either physician’s choice for standard of care or standard of care plus continuous infusion of ornithine phenylacetate for up to 5 days. Patients were assigned to one of three dosing groups (20 g, 15 g, or 10 g), based on severity of underlying liver disease; those with the most severe disease received the lowest dose.
Reduction in plasma ammonia levels correlated significantly with clinical improvement. At 48 hours, meaningful clinical improvement occurred in 84% of patients on ornithine phenylacetate, compared with 58% of placebo patients, according to Robert S. Rahimi, MD, of Baylor University, Dallas, and his colleagues.
“So, this may be an option for our hepatic encephalopathy patients who are admitted to the hospital and need acute treatment,” Dr. Kowdley said.
Dr. Kowdley finished up with two studies on primary biliary cholangitis (PBC).
Carla Murillo Perez, MD, of Toronto General Hospital and her colleagues in the Global PBC Study Group investigated the role of serum bilirubin in predicting transplant-free survival in patients with PBC (abstract 70).
When serum bilirubin levels from a previous study were input into a Cox regression analysis as a cubic spline function, then adjusted for factors such as age, sex, treatment with ursodeoxycholic acid, and year of diagnosis, the investigators found that patients with serum bilirubin levels of 0.7 times the upper limit of normal had a significantly increased risk of liver transplantation or death.
“We may want to be more sensitive in looking at bilirubin levels,” Dr. Kowdley said.
Another small but notable study presented by Gideon M. Hirschfield, MD, of the University of Birmingham (England), looked into whether a lower dose of seladelpar would safely and effectively lower alkaline phosphatase (AP) levels in PBC patients. A previous study of seladelpar at 50 mg and 200 mg doses indicated the drug’s effectiveness; however, the study was stopped because of the development of grade 3 alanine aminotransferase increases in a number of patients (Lancet Gastroenterol Hepatol. 2017;2;716-26).
Dr. Hirschfield and colleagues enrolled 24 patients and randomized 12 to seladelpar 5 mg and another 12 to 10 mg. The study cohort was mostly female, with an average age of 58 years. Most were either intolerant of or inadequately treated by ursodeoxycholic acid. AP levels were reduced significantly over time in both groups; however, differences between the groups were not significant, the investigators noted.
The Liver Meeting will be held in San Francisco in 2018, taking place Nov. 9-13. Many investigators in these trials reported relevant conflicts of interest; information is available (open access) in a supplement to Hepatology.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
AT THE LIVER MEETING 2017
VIDEO: Huge database analysis affirms genes associated with NAFLD
WASHINGTON – A genome-wide association study of the Million Veteran Program confirmed three specific genes associated with nonalcoholic fatty liver disease, underscoring the robustness of those loci as well as the clinical phenotyping in the program.
Marina Serper, MD, of the Cpl. Michael J. Crescenz Veterans Affairs Medical Center, and University of Pennsylvania, both in Philadelphia, and her colleagues looked at patients with NAFLD in the Million Veterans Program (MVP), a project of the federal Precision Medicine Initiative designed to leverage the data and experience associated with the Veterans Health Care Administration, Dr. Serper said at the annual meeting of the American Association for the Study of Liver Diseases. Currently, more than 600,000 veterans have been enrolled at over 50 sites across the United States, with a goal of 1 million participants by 2020.
About one-third (108,458) of 352,953 MVP enrollees whose DNA has been analyzed met the study definition of NAFLD. In their study, Dr. Serper and her associates defined the clinical phenotype of NAFLD as patients having abnormal alanine aminotransferase levels (greater than 30 U/L for men and greater than 20 U/L for women) detected twice in a 2-year period, plus at least 1 metabolic risk factor, such as body mass index of 30 kg/m2 or greater, type 2 diabetes or prediabetes, hypertension, or dyslipidemia. Further, included patients did not have alcohol misuse disorders or viral hepatitis.
Most patients were male (90%) and white (72%), with a median age of 64 years. More than half (56%) had a BMI of 30 or greater, 30% were diagnosed with type 2 diabetes, and 71% with dyslipidemia – aligning the cohort closely with rest of the MVP population, Dr. Serper said.
Logistic regression analysis adjusted for age, sex, and principal components stratified by ancestry (European, African American, and Hispanic). On initial analysis, 21 genetic loci met the criteria for genome-wide significant association; specifically, investigators successfully replicated three key variants that have been previously seen associated with NAFLD – PNPLA3, ERLIN1, and TRIB1.
“We were able to use clinical VA data to come up with a robust and clinically relevant definition and validate that definition because the genes we found associated with our definition of NAFLD have previously been shown by others who used biopsy data and imaging data for steatosis,” Dr. Serper said in a video interview. “This is important because the diagnosis of fatty liver disease is really a clinical diagnosis.”
Panel moderator Elizabeth K. Speliotes, MD, of the University of Michigan, Ann Arbor, said, “Really what makes us unique is our genetics and our exposures and the environment, and if we can capture that better, then we can use that to more precisely tailor diagnoses and treatments for patients. That’s really the hope of the next generation.”
The study was supported by the VA Office of Research and Development award 1I01BX003362. Dr. Serper disclosed no relevant conflicts of interest.
Watch this video interview with Dr. Serper and Dr. Chang for more information on the Million Veteran Program.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – A genome-wide association study of the Million Veteran Program confirmed three specific genes associated with nonalcoholic fatty liver disease, underscoring the robustness of those loci as well as the clinical phenotyping in the program.
Marina Serper, MD, of the Cpl. Michael J. Crescenz Veterans Affairs Medical Center, and University of Pennsylvania, both in Philadelphia, and her colleagues looked at patients with NAFLD in the Million Veterans Program (MVP), a project of the federal Precision Medicine Initiative designed to leverage the data and experience associated with the Veterans Health Care Administration, Dr. Serper said at the annual meeting of the American Association for the Study of Liver Diseases. Currently, more than 600,000 veterans have been enrolled at over 50 sites across the United States, with a goal of 1 million participants by 2020.
About one-third (108,458) of 352,953 MVP enrollees whose DNA has been analyzed met the study definition of NAFLD. In their study, Dr. Serper and her associates defined the clinical phenotype of NAFLD as patients having abnormal alanine aminotransferase levels (greater than 30 U/L for men and greater than 20 U/L for women) detected twice in a 2-year period, plus at least 1 metabolic risk factor, such as body mass index of 30 kg/m2 or greater, type 2 diabetes or prediabetes, hypertension, or dyslipidemia. Further, included patients did not have alcohol misuse disorders or viral hepatitis.
Most patients were male (90%) and white (72%), with a median age of 64 years. More than half (56%) had a BMI of 30 or greater, 30% were diagnosed with type 2 diabetes, and 71% with dyslipidemia – aligning the cohort closely with rest of the MVP population, Dr. Serper said.
Logistic regression analysis adjusted for age, sex, and principal components stratified by ancestry (European, African American, and Hispanic). On initial analysis, 21 genetic loci met the criteria for genome-wide significant association; specifically, investigators successfully replicated three key variants that have been previously seen associated with NAFLD – PNPLA3, ERLIN1, and TRIB1.
“We were able to use clinical VA data to come up with a robust and clinically relevant definition and validate that definition because the genes we found associated with our definition of NAFLD have previously been shown by others who used biopsy data and imaging data for steatosis,” Dr. Serper said in a video interview. “This is important because the diagnosis of fatty liver disease is really a clinical diagnosis.”
Panel moderator Elizabeth K. Speliotes, MD, of the University of Michigan, Ann Arbor, said, “Really what makes us unique is our genetics and our exposures and the environment, and if we can capture that better, then we can use that to more precisely tailor diagnoses and treatments for patients. That’s really the hope of the next generation.”
The study was supported by the VA Office of Research and Development award 1I01BX003362. Dr. Serper disclosed no relevant conflicts of interest.
Watch this video interview with Dr. Serper and Dr. Chang for more information on the Million Veteran Program.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – A genome-wide association study of the Million Veteran Program confirmed three specific genes associated with nonalcoholic fatty liver disease, underscoring the robustness of those loci as well as the clinical phenotyping in the program.
Marina Serper, MD, of the Cpl. Michael J. Crescenz Veterans Affairs Medical Center, and University of Pennsylvania, both in Philadelphia, and her colleagues looked at patients with NAFLD in the Million Veterans Program (MVP), a project of the federal Precision Medicine Initiative designed to leverage the data and experience associated with the Veterans Health Care Administration, Dr. Serper said at the annual meeting of the American Association for the Study of Liver Diseases. Currently, more than 600,000 veterans have been enrolled at over 50 sites across the United States, with a goal of 1 million participants by 2020.
About one-third (108,458) of 352,953 MVP enrollees whose DNA has been analyzed met the study definition of NAFLD. In their study, Dr. Serper and her associates defined the clinical phenotype of NAFLD as patients having abnormal alanine aminotransferase levels (greater than 30 U/L for men and greater than 20 U/L for women) detected twice in a 2-year period, plus at least 1 metabolic risk factor, such as body mass index of 30 kg/m2 or greater, type 2 diabetes or prediabetes, hypertension, or dyslipidemia. Further, included patients did not have alcohol misuse disorders or viral hepatitis.
Most patients were male (90%) and white (72%), with a median age of 64 years. More than half (56%) had a BMI of 30 or greater, 30% were diagnosed with type 2 diabetes, and 71% with dyslipidemia – aligning the cohort closely with rest of the MVP population, Dr. Serper said.
Logistic regression analysis adjusted for age, sex, and principal components stratified by ancestry (European, African American, and Hispanic). On initial analysis, 21 genetic loci met the criteria for genome-wide significant association; specifically, investigators successfully replicated three key variants that have been previously seen associated with NAFLD – PNPLA3, ERLIN1, and TRIB1.
“We were able to use clinical VA data to come up with a robust and clinically relevant definition and validate that definition because the genes we found associated with our definition of NAFLD have previously been shown by others who used biopsy data and imaging data for steatosis,” Dr. Serper said in a video interview. “This is important because the diagnosis of fatty liver disease is really a clinical diagnosis.”
Panel moderator Elizabeth K. Speliotes, MD, of the University of Michigan, Ann Arbor, said, “Really what makes us unique is our genetics and our exposures and the environment, and if we can capture that better, then we can use that to more precisely tailor diagnoses and treatments for patients. That’s really the hope of the next generation.”
The study was supported by the VA Office of Research and Development award 1I01BX003362. Dr. Serper disclosed no relevant conflicts of interest.
Watch this video interview with Dr. Serper and Dr. Chang for more information on the Million Veteran Program.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
AT THE LIVER MEETING 2017
Key clinical point:
Major finding: About one-third (108,458) of 352,953 Million Veteran Program enrollees whose DNA has been analyzed met the study definition of NAFLD.
Data source: Genome-wide association study of more than 100,000 patients.
Disclosures: The study was supported by the Veterans Administration Office of Research and Development award 1I01BX003362. Dr. Serper disclosed no relevant conflicts of interest.
Carvedilol fails to reduce variceal bleeds in acute-on-chronic liver failure
WASHINGTON – Treatment with carvedilol reduced the incidence of sepsis and acute kidney injury and improved survival at 28 days but did not significantly reduce the progression of esophageal varices in patients with acute-on-chronic liver failure.
A total of 136 patients with acute-on-chronic liver failure with small or no esophageal varices and a hepatic venous pressure gradient (HVPG) of 12 mm Hg or greater were enrolled in a single center, prospective, open-label, randomized controlled trial: 66 were randomized to carvedilol and 70 to placebo, according to Sumeet Kainth, MD, of the Institute of Liver and Biliary Sciences in New Delhi.
More than 90% of patients were men with a mean age of 44 years, and composition of the treatment and placebo groups was similar. About 70% in each group had alcoholic hepatitis (the reason for acute liver failure in most). Mean Model for End-Stage Liver Disease (MELD) scores were about 25. Hemodynamic parameters also were comparable, with a mean HVPG of about 19, Dr. Kainth said at the annual meeting of the American Association for the Study of Liver Diseases.
Patients in the treatment group received a median maximum tolerated dose of carvedilol of 12.5 mg, with a range of 3.13 mg to 25 mg.
Morbidity and mortality were high, as is expected with acute-on-chronic liver failure, he noted. A total of 36 patients died before the end of the 90-day study period. Another 23 experienced adverse events and 2 progressed to liver transplant.
HVPG at 90 days decreased significantly in both groups. In the carvedilol group, 90-day HVPG was 16 mm Hg, compared with 19.7 mm Hg at baseline (P less than .01). For placebo patients, 90-day HVPG spontaneously improved to 14.8 mm Hg, compared with a baseline of 17.2 mm Hg (P less than .01).
Carvedilol did not significantly slow the development or growth of varices, however, Dr. Kainth said. At 90 days, varices had progressed in 9 of 40 patients (22.5%) of patients on carvedilol and 8 of 31 (25.8%) of placebo patients.
Significantly fewer patients in the carvedilol group developed acute kidney injury at 28 days (14% vs. 38% on placebo) and sepsis (5% vs. 20%). Mortality also was reduced significantly at 28 days (11% vs. 24%), he reported.
Treatment with carvedilol did not achieve significant reductions in variceal bleeding, “possibly due to the low number of bleeds seen in the study [because of] the exclusion of patients with large varices,” Dr. Kainth said.
The study was sponsored by Institute of Liver and Biliary Sciences. Dr. Kainth reported no relevant conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Treatment with carvedilol reduced the incidence of sepsis and acute kidney injury and improved survival at 28 days but did not significantly reduce the progression of esophageal varices in patients with acute-on-chronic liver failure.
A total of 136 patients with acute-on-chronic liver failure with small or no esophageal varices and a hepatic venous pressure gradient (HVPG) of 12 mm Hg or greater were enrolled in a single center, prospective, open-label, randomized controlled trial: 66 were randomized to carvedilol and 70 to placebo, according to Sumeet Kainth, MD, of the Institute of Liver and Biliary Sciences in New Delhi.
More than 90% of patients were men with a mean age of 44 years, and composition of the treatment and placebo groups was similar. About 70% in each group had alcoholic hepatitis (the reason for acute liver failure in most). Mean Model for End-Stage Liver Disease (MELD) scores were about 25. Hemodynamic parameters also were comparable, with a mean HVPG of about 19, Dr. Kainth said at the annual meeting of the American Association for the Study of Liver Diseases.
Patients in the treatment group received a median maximum tolerated dose of carvedilol of 12.5 mg, with a range of 3.13 mg to 25 mg.
Morbidity and mortality were high, as is expected with acute-on-chronic liver failure, he noted. A total of 36 patients died before the end of the 90-day study period. Another 23 experienced adverse events and 2 progressed to liver transplant.
HVPG at 90 days decreased significantly in both groups. In the carvedilol group, 90-day HVPG was 16 mm Hg, compared with 19.7 mm Hg at baseline (P less than .01). For placebo patients, 90-day HVPG spontaneously improved to 14.8 mm Hg, compared with a baseline of 17.2 mm Hg (P less than .01).
Carvedilol did not significantly slow the development or growth of varices, however, Dr. Kainth said. At 90 days, varices had progressed in 9 of 40 patients (22.5%) of patients on carvedilol and 8 of 31 (25.8%) of placebo patients.
Significantly fewer patients in the carvedilol group developed acute kidney injury at 28 days (14% vs. 38% on placebo) and sepsis (5% vs. 20%). Mortality also was reduced significantly at 28 days (11% vs. 24%), he reported.
Treatment with carvedilol did not achieve significant reductions in variceal bleeding, “possibly due to the low number of bleeds seen in the study [because of] the exclusion of patients with large varices,” Dr. Kainth said.
The study was sponsored by Institute of Liver and Biliary Sciences. Dr. Kainth reported no relevant conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Treatment with carvedilol reduced the incidence of sepsis and acute kidney injury and improved survival at 28 days but did not significantly reduce the progression of esophageal varices in patients with acute-on-chronic liver failure.
A total of 136 patients with acute-on-chronic liver failure with small or no esophageal varices and a hepatic venous pressure gradient (HVPG) of 12 mm Hg or greater were enrolled in a single center, prospective, open-label, randomized controlled trial: 66 were randomized to carvedilol and 70 to placebo, according to Sumeet Kainth, MD, of the Institute of Liver and Biliary Sciences in New Delhi.
More than 90% of patients were men with a mean age of 44 years, and composition of the treatment and placebo groups was similar. About 70% in each group had alcoholic hepatitis (the reason for acute liver failure in most). Mean Model for End-Stage Liver Disease (MELD) scores were about 25. Hemodynamic parameters also were comparable, with a mean HVPG of about 19, Dr. Kainth said at the annual meeting of the American Association for the Study of Liver Diseases.
Patients in the treatment group received a median maximum tolerated dose of carvedilol of 12.5 mg, with a range of 3.13 mg to 25 mg.
Morbidity and mortality were high, as is expected with acute-on-chronic liver failure, he noted. A total of 36 patients died before the end of the 90-day study period. Another 23 experienced adverse events and 2 progressed to liver transplant.
HVPG at 90 days decreased significantly in both groups. In the carvedilol group, 90-day HVPG was 16 mm Hg, compared with 19.7 mm Hg at baseline (P less than .01). For placebo patients, 90-day HVPG spontaneously improved to 14.8 mm Hg, compared with a baseline of 17.2 mm Hg (P less than .01).
Carvedilol did not significantly slow the development or growth of varices, however, Dr. Kainth said. At 90 days, varices had progressed in 9 of 40 patients (22.5%) of patients on carvedilol and 8 of 31 (25.8%) of placebo patients.
Significantly fewer patients in the carvedilol group developed acute kidney injury at 28 days (14% vs. 38% on placebo) and sepsis (5% vs. 20%). Mortality also was reduced significantly at 28 days (11% vs. 24%), he reported.
Treatment with carvedilol did not achieve significant reductions in variceal bleeding, “possibly due to the low number of bleeds seen in the study [because of] the exclusion of patients with large varices,” Dr. Kainth said.
The study was sponsored by Institute of Liver and Biliary Sciences. Dr. Kainth reported no relevant conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
AT THE LIVER MEETING 2017
Key clinical point:
Major finding: At 90 days, varices had progressed in 9 of 40 (22.5%) patients on carvedilol vs. 8 of 31 (25.8%) of placebo patients.
Data source: A single-center, prospective, open-label, randomized controlled trial of 136 patients with acute-on-chronic liver failure.
Disclosures: The study was sponsored by the Institute of Liver and Biliary Sciences. Dr. Kainth reported no relevant conflicts of interest.