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Weekly number of Zika-infected pregnancies drops by half
There were 146 new cases of pregnant women with laboratory evidence of Zika infection reported in the United States for the week ending Nov. 3 – just about half of the 288-case increase reported the week before, according to Centers for Disease Control and Prevention.
For the year so far, there have been 1,057 cases of pregnant women with Zika in the states and the District of Columbia – 52 for the week ending Nov. 3 – and 2,357 cases in the territories, the CDC announced, with 94 reported in the most recent week. The total number of U.S. cases – 3,414 – is up by 4.4% over the previous week.
The CDC also reported one new infant born with Zika-related birth defects for the week ending Nov. 3, bringing the total for the year to 26 in the states/D.C. There were no new Zika-related pregnancy losses reported, so the total remains at five. State-level data are not being reported to protect the privacy of affected women and children.
The CDC is no longer reporting adverse pregnancy outcomes for the territories because Puerto Rico is not using the same “inclusion criteria to monitor brain abnormalities and other adverse pregnancy outcomes.” As of Sept. 29 – the date of the last territorial report – there had been one liveborn infant and one pregnancy loss related to Zika.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
There were 146 new cases of pregnant women with laboratory evidence of Zika infection reported in the United States for the week ending Nov. 3 – just about half of the 288-case increase reported the week before, according to Centers for Disease Control and Prevention.
For the year so far, there have been 1,057 cases of pregnant women with Zika in the states and the District of Columbia – 52 for the week ending Nov. 3 – and 2,357 cases in the territories, the CDC announced, with 94 reported in the most recent week. The total number of U.S. cases – 3,414 – is up by 4.4% over the previous week.
The CDC also reported one new infant born with Zika-related birth defects for the week ending Nov. 3, bringing the total for the year to 26 in the states/D.C. There were no new Zika-related pregnancy losses reported, so the total remains at five. State-level data are not being reported to protect the privacy of affected women and children.
The CDC is no longer reporting adverse pregnancy outcomes for the territories because Puerto Rico is not using the same “inclusion criteria to monitor brain abnormalities and other adverse pregnancy outcomes.” As of Sept. 29 – the date of the last territorial report – there had been one liveborn infant and one pregnancy loss related to Zika.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
There were 146 new cases of pregnant women with laboratory evidence of Zika infection reported in the United States for the week ending Nov. 3 – just about half of the 288-case increase reported the week before, according to Centers for Disease Control and Prevention.
For the year so far, there have been 1,057 cases of pregnant women with Zika in the states and the District of Columbia – 52 for the week ending Nov. 3 – and 2,357 cases in the territories, the CDC announced, with 94 reported in the most recent week. The total number of U.S. cases – 3,414 – is up by 4.4% over the previous week.
The CDC also reported one new infant born with Zika-related birth defects for the week ending Nov. 3, bringing the total for the year to 26 in the states/D.C. There were no new Zika-related pregnancy losses reported, so the total remains at five. State-level data are not being reported to protect the privacy of affected women and children.
The CDC is no longer reporting adverse pregnancy outcomes for the territories because Puerto Rico is not using the same “inclusion criteria to monitor brain abnormalities and other adverse pregnancy outcomes.” As of Sept. 29 – the date of the last territorial report – there had been one liveborn infant and one pregnancy loss related to Zika.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
Biologic-naive psoriasis patients get biggest boost with treatment
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Key clinical point:
Major finding: Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another.
Data source: A systematic review of 15 observational studies of adults with psoriasis evaluating anti-TNF agents or ustekinumab as second-line or later-line treatments.
Disclosures: Dr. Feldman disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis.
Therapeutic alternative to liver transplantation could be on horizon in NASH
BOSTON – A novel therapeutic approach to nonalcoholic steatohepatitis could one day mean sufferers of this severe form of nonalcoholic fatty liver disease have an alternative to transplantation.
Preclinical findings from a study using mesenchymal stem cells adapted from unsuitable organs for transplant have shown promise in suppressing inflammation in nonalcoholic steatohepatitis (NASH).
By adding an inflammatory cocktail to cell cultures, with or without immunosuppression with cyclosporine, Dr. Gellynck and his colleagues were able to provoke secretion of anti-inflammatory and antifibrotic cytokines. HepaStem was shown to inhibit the T-lymphocyte response to the inflammation and also suppress the dendritic cell generation and function in co-culture experiments. In a NASH disease model culture, the immunosuppression did not solely affect disease progression, but cell-based treatment significantly and dose-dependently decreased collagen levels. A single HepaStem injection “significantly” decreased the nonalcoholic fatty liver disease activity disease score, supporting the proposed mechanism of action, namely reduced inflammation.
Dr. Gellynck and his colleagues believe their findings warrant phase I/II studies in humans with NASH.
All study workers are employed by Promethera Biosciences.
[email protected]
On Twitter @whitneymcknight
BOSTON – A novel therapeutic approach to nonalcoholic steatohepatitis could one day mean sufferers of this severe form of nonalcoholic fatty liver disease have an alternative to transplantation.
Preclinical findings from a study using mesenchymal stem cells adapted from unsuitable organs for transplant have shown promise in suppressing inflammation in nonalcoholic steatohepatitis (NASH).
By adding an inflammatory cocktail to cell cultures, with or without immunosuppression with cyclosporine, Dr. Gellynck and his colleagues were able to provoke secretion of anti-inflammatory and antifibrotic cytokines. HepaStem was shown to inhibit the T-lymphocyte response to the inflammation and also suppress the dendritic cell generation and function in co-culture experiments. In a NASH disease model culture, the immunosuppression did not solely affect disease progression, but cell-based treatment significantly and dose-dependently decreased collagen levels. A single HepaStem injection “significantly” decreased the nonalcoholic fatty liver disease activity disease score, supporting the proposed mechanism of action, namely reduced inflammation.
Dr. Gellynck and his colleagues believe their findings warrant phase I/II studies in humans with NASH.
All study workers are employed by Promethera Biosciences.
[email protected]
On Twitter @whitneymcknight
BOSTON – A novel therapeutic approach to nonalcoholic steatohepatitis could one day mean sufferers of this severe form of nonalcoholic fatty liver disease have an alternative to transplantation.
Preclinical findings from a study using mesenchymal stem cells adapted from unsuitable organs for transplant have shown promise in suppressing inflammation in nonalcoholic steatohepatitis (NASH).
By adding an inflammatory cocktail to cell cultures, with or without immunosuppression with cyclosporine, Dr. Gellynck and his colleagues were able to provoke secretion of anti-inflammatory and antifibrotic cytokines. HepaStem was shown to inhibit the T-lymphocyte response to the inflammation and also suppress the dendritic cell generation and function in co-culture experiments. In a NASH disease model culture, the immunosuppression did not solely affect disease progression, but cell-based treatment significantly and dose-dependently decreased collagen levels. A single HepaStem injection “significantly” decreased the nonalcoholic fatty liver disease activity disease score, supporting the proposed mechanism of action, namely reduced inflammation.
Dr. Gellynck and his colleagues believe their findings warrant phase I/II studies in humans with NASH.
All study workers are employed by Promethera Biosciences.
[email protected]
On Twitter @whitneymcknight
FROM THE LIVER MEETING 2016
Cenicriviroc was well-tolerated but did not outperform placebo across all endpoints
Cenicriviroc, an oral chemokine receptor CCR/5 antagonist, was well tolerated, although it did not best placebo across all study endpoints, according to results of a 1-year phase IIb study released in an abstract in advance of the annual meeting of the American Association for the Study of Liver Diseases.
A correlation between treatment benefit and disease severity was reported by Arun J. Sanyal, MD, of Virginia Commonwealth University in Richmond, and coworkers, however.
In the 2-year, multinational, phase IIb, double-blind CENTAUR (Efficacy and Safety Study of Cenicriviroc for the Treatment of NASH in Adult Subjects With Liver Fibrosis) study, 289 adults with chronic liver disease were randomly assigned to either 150 mg cenicriviroc (CVC) once daily or to placebo. At baseline, study participants had either histologically defined nonalcoholic steatohepatitis, a nonalcoholic fatty liver disease score (NAS) of 4 or greater, or liver fibrosis between stages 1 and 3. Just over half of the cohort were women, 72% had metabolic syndrome, and 53% had diabetes. Three-quarters had an NAS score of 5 or higher, and 67% had fibrosis between stages 2 and 3. The mean body mass index across the study was 34 kg/m2.
At 1 year, liver biopsy showed that 16% of the CVC group had achieved at least a 2-point improvement in NAS, 3% less than controls (P = .519). Resolution of steatohepatitis with no worsening of fibrosis was higher in the study arm, compared with controls: 8% vs. 6% (P = .494). A significant difference was seen in members of the study arm who had advanced disease characteristics at baseline, compared with controls, by at least one stage in fibrosis improvement, with no worsening of steatohepatitis (P = .023). Across the study, improvement in fibrosis by two stages was seen in eight patients given CVC and in three controls. Progression to cirrhosis occurred in two members of the study arm and in five controls.
Adverse treatment-related events were similar across the study. The most commonly reported were fatigue (2.8%) and diarrhea (2.1%) in the study arm and headache (3.5%) in controls.
Most of the researchers associated with this study have industry relationships, including Brian L. Wiens, PhD, Pamela Vig, PhD, Star Seyedkazemi, PharmD, and Eric Lefebvre, MD, all of whom are employed by study sponsor, Tobira Therapeutics.
[email protected]
On Twitter @whitneymcknight
Cenicriviroc, an oral chemokine receptor CCR/5 antagonist, was well tolerated, although it did not best placebo across all study endpoints, according to results of a 1-year phase IIb study released in an abstract in advance of the annual meeting of the American Association for the Study of Liver Diseases.
A correlation between treatment benefit and disease severity was reported by Arun J. Sanyal, MD, of Virginia Commonwealth University in Richmond, and coworkers, however.
In the 2-year, multinational, phase IIb, double-blind CENTAUR (Efficacy and Safety Study of Cenicriviroc for the Treatment of NASH in Adult Subjects With Liver Fibrosis) study, 289 adults with chronic liver disease were randomly assigned to either 150 mg cenicriviroc (CVC) once daily or to placebo. At baseline, study participants had either histologically defined nonalcoholic steatohepatitis, a nonalcoholic fatty liver disease score (NAS) of 4 or greater, or liver fibrosis between stages 1 and 3. Just over half of the cohort were women, 72% had metabolic syndrome, and 53% had diabetes. Three-quarters had an NAS score of 5 or higher, and 67% had fibrosis between stages 2 and 3. The mean body mass index across the study was 34 kg/m2.
At 1 year, liver biopsy showed that 16% of the CVC group had achieved at least a 2-point improvement in NAS, 3% less than controls (P = .519). Resolution of steatohepatitis with no worsening of fibrosis was higher in the study arm, compared with controls: 8% vs. 6% (P = .494). A significant difference was seen in members of the study arm who had advanced disease characteristics at baseline, compared with controls, by at least one stage in fibrosis improvement, with no worsening of steatohepatitis (P = .023). Across the study, improvement in fibrosis by two stages was seen in eight patients given CVC and in three controls. Progression to cirrhosis occurred in two members of the study arm and in five controls.
Adverse treatment-related events were similar across the study. The most commonly reported were fatigue (2.8%) and diarrhea (2.1%) in the study arm and headache (3.5%) in controls.
Most of the researchers associated with this study have industry relationships, including Brian L. Wiens, PhD, Pamela Vig, PhD, Star Seyedkazemi, PharmD, and Eric Lefebvre, MD, all of whom are employed by study sponsor, Tobira Therapeutics.
[email protected]
On Twitter @whitneymcknight
Cenicriviroc, an oral chemokine receptor CCR/5 antagonist, was well tolerated, although it did not best placebo across all study endpoints, according to results of a 1-year phase IIb study released in an abstract in advance of the annual meeting of the American Association for the Study of Liver Diseases.
A correlation between treatment benefit and disease severity was reported by Arun J. Sanyal, MD, of Virginia Commonwealth University in Richmond, and coworkers, however.
In the 2-year, multinational, phase IIb, double-blind CENTAUR (Efficacy and Safety Study of Cenicriviroc for the Treatment of NASH in Adult Subjects With Liver Fibrosis) study, 289 adults with chronic liver disease were randomly assigned to either 150 mg cenicriviroc (CVC) once daily or to placebo. At baseline, study participants had either histologically defined nonalcoholic steatohepatitis, a nonalcoholic fatty liver disease score (NAS) of 4 or greater, or liver fibrosis between stages 1 and 3. Just over half of the cohort were women, 72% had metabolic syndrome, and 53% had diabetes. Three-quarters had an NAS score of 5 or higher, and 67% had fibrosis between stages 2 and 3. The mean body mass index across the study was 34 kg/m2.
At 1 year, liver biopsy showed that 16% of the CVC group had achieved at least a 2-point improvement in NAS, 3% less than controls (P = .519). Resolution of steatohepatitis with no worsening of fibrosis was higher in the study arm, compared with controls: 8% vs. 6% (P = .494). A significant difference was seen in members of the study arm who had advanced disease characteristics at baseline, compared with controls, by at least one stage in fibrosis improvement, with no worsening of steatohepatitis (P = .023). Across the study, improvement in fibrosis by two stages was seen in eight patients given CVC and in three controls. Progression to cirrhosis occurred in two members of the study arm and in five controls.
Adverse treatment-related events were similar across the study. The most commonly reported were fatigue (2.8%) and diarrhea (2.1%) in the study arm and headache (3.5%) in controls.
Most of the researchers associated with this study have industry relationships, including Brian L. Wiens, PhD, Pamela Vig, PhD, Star Seyedkazemi, PharmD, and Eric Lefebvre, MD, all of whom are employed by study sponsor, Tobira Therapeutics.
[email protected]
On Twitter @whitneymcknight
FROM THE LIVER MEETING 2016
MBX-8025 yields ‘striking’ efficacy results but new safety signal in primary biliary cholangitis
The investigational peroxisome proliferator–activated receptor delta agonist MBX-8025 exhibited a “striking anticholestatic effect” without causing pruritus in a phase II trial of 35 patients with primary biliary cholangitis.
But three patients developed grade 3 increases in serum transaminase levels that reversed when they stopped treatment, David Jones, MD, of the University of Newcastle (United Kingdom) and his associates will report at the annual meeting of the American Association of Liver Diseases. The effect seemed dose related, so future studies should explore whether MBX-8025 is effective at lower doses, they concluded in a late-breaking abstract released in advance of the meeting.
Primary biliary cholangitis, an important cause of end-stage liver disease, is initially associated with fatigue and pruritus and often responds inadequately to first-line treatment with ursodeoxycholic acid. MBX-8025 selectively activates the peroxisome proliferator–activated receptor delta, a nuclear receptor that regulates genes involved in lipid storage and transport. In prior studies, MBX-8025 decreased serum alkaline phosphatase (ALP) levels and seemed well tolerated in healthy volunteers and patients with dyslipidemia, the investigators noted.
As a next step, they randomly assigned patients with primary biliary cholangitis whose ALP levels remained at least 1.67 times the upper limit of normal, despite at least 12 months of ursodeoxycholic acid therapy, to receive either placebo or 50 or 200 mg MBX-8026 for 12 weeks. The primary outcome was percent change in ALP levels, which, at baseline, averaged 233 U/L in the placebo group, 312 U/L in the 50 mg group, and 248 U/L in the 200-mg group.
At the end of treatment, ALP levels had dropped by an average of 63% in the 200-mg MBX-8025 group, 53% in the 50-mg group, and 2% in the placebo group (P less than .0001 for each dose effect versus placebo). Percent decreases in gamma-glutamyl transferase averaged 43% for both dose groups and 3% in the placebo group. Median levels of 7-alpha-hydroxy-4-cholesten-3-one, a marker of bile acid synthesis, fell by 77% in the 200-mg group and by 55% in the 50-mg group, but rose by 29% in the placebo group. Both the 50-mg and the 200-mg doses yielded statistically similar effects on all three cholestatic markers.
Although MBX-8025 did not appear to cause or worsen pruritus, 3 of the 35 patients developed rapid, asymptomatic, grade 3 increases in serum levels of alanine aminotransferase, the researchers reported. Two patients were taking 200 mg MBX-8025, and one was taking 50 mg. The effect fully reversed after patients stopped treatment, and was not associated with hyperbilirubinemia. Another patient in the 200-mg group stopped treatment because of what the investigators called “a muscle adverse event [that we] considered drug-related.”
The trial was halted halfway through recruitment, having established proof of concept, the investigators concluded. Because MBX-8025 is primarily excreted in bile, and primary biliary cholangitis obstructs bile flow, affected patients might have had more hepatic exposure to the agent than did those in previous trials, and this might explain the new safety signal, they noted.
CymaBay Therapeutics makes MBX-8025 and funded the trial. Dr. Jones disclosed ties to Intercept, GlaxoSmithKline, Novartis, and Falk. Eight coinvestigators disclosed employment with or other ties to CymaBay Therapeutics. The other three coinvestigators had no relevant disclosures.
The investigational peroxisome proliferator–activated receptor delta agonist MBX-8025 exhibited a “striking anticholestatic effect” without causing pruritus in a phase II trial of 35 patients with primary biliary cholangitis.
But three patients developed grade 3 increases in serum transaminase levels that reversed when they stopped treatment, David Jones, MD, of the University of Newcastle (United Kingdom) and his associates will report at the annual meeting of the American Association of Liver Diseases. The effect seemed dose related, so future studies should explore whether MBX-8025 is effective at lower doses, they concluded in a late-breaking abstract released in advance of the meeting.
Primary biliary cholangitis, an important cause of end-stage liver disease, is initially associated with fatigue and pruritus and often responds inadequately to first-line treatment with ursodeoxycholic acid. MBX-8025 selectively activates the peroxisome proliferator–activated receptor delta, a nuclear receptor that regulates genes involved in lipid storage and transport. In prior studies, MBX-8025 decreased serum alkaline phosphatase (ALP) levels and seemed well tolerated in healthy volunteers and patients with dyslipidemia, the investigators noted.
As a next step, they randomly assigned patients with primary biliary cholangitis whose ALP levels remained at least 1.67 times the upper limit of normal, despite at least 12 months of ursodeoxycholic acid therapy, to receive either placebo or 50 or 200 mg MBX-8026 for 12 weeks. The primary outcome was percent change in ALP levels, which, at baseline, averaged 233 U/L in the placebo group, 312 U/L in the 50 mg group, and 248 U/L in the 200-mg group.
At the end of treatment, ALP levels had dropped by an average of 63% in the 200-mg MBX-8025 group, 53% in the 50-mg group, and 2% in the placebo group (P less than .0001 for each dose effect versus placebo). Percent decreases in gamma-glutamyl transferase averaged 43% for both dose groups and 3% in the placebo group. Median levels of 7-alpha-hydroxy-4-cholesten-3-one, a marker of bile acid synthesis, fell by 77% in the 200-mg group and by 55% in the 50-mg group, but rose by 29% in the placebo group. Both the 50-mg and the 200-mg doses yielded statistically similar effects on all three cholestatic markers.
Although MBX-8025 did not appear to cause or worsen pruritus, 3 of the 35 patients developed rapid, asymptomatic, grade 3 increases in serum levels of alanine aminotransferase, the researchers reported. Two patients were taking 200 mg MBX-8025, and one was taking 50 mg. The effect fully reversed after patients stopped treatment, and was not associated with hyperbilirubinemia. Another patient in the 200-mg group stopped treatment because of what the investigators called “a muscle adverse event [that we] considered drug-related.”
The trial was halted halfway through recruitment, having established proof of concept, the investigators concluded. Because MBX-8025 is primarily excreted in bile, and primary biliary cholangitis obstructs bile flow, affected patients might have had more hepatic exposure to the agent than did those in previous trials, and this might explain the new safety signal, they noted.
CymaBay Therapeutics makes MBX-8025 and funded the trial. Dr. Jones disclosed ties to Intercept, GlaxoSmithKline, Novartis, and Falk. Eight coinvestigators disclosed employment with or other ties to CymaBay Therapeutics. The other three coinvestigators had no relevant disclosures.
The investigational peroxisome proliferator–activated receptor delta agonist MBX-8025 exhibited a “striking anticholestatic effect” without causing pruritus in a phase II trial of 35 patients with primary biliary cholangitis.
But three patients developed grade 3 increases in serum transaminase levels that reversed when they stopped treatment, David Jones, MD, of the University of Newcastle (United Kingdom) and his associates will report at the annual meeting of the American Association of Liver Diseases. The effect seemed dose related, so future studies should explore whether MBX-8025 is effective at lower doses, they concluded in a late-breaking abstract released in advance of the meeting.
Primary biliary cholangitis, an important cause of end-stage liver disease, is initially associated with fatigue and pruritus and often responds inadequately to first-line treatment with ursodeoxycholic acid. MBX-8025 selectively activates the peroxisome proliferator–activated receptor delta, a nuclear receptor that regulates genes involved in lipid storage and transport. In prior studies, MBX-8025 decreased serum alkaline phosphatase (ALP) levels and seemed well tolerated in healthy volunteers and patients with dyslipidemia, the investigators noted.
As a next step, they randomly assigned patients with primary biliary cholangitis whose ALP levels remained at least 1.67 times the upper limit of normal, despite at least 12 months of ursodeoxycholic acid therapy, to receive either placebo or 50 or 200 mg MBX-8026 for 12 weeks. The primary outcome was percent change in ALP levels, which, at baseline, averaged 233 U/L in the placebo group, 312 U/L in the 50 mg group, and 248 U/L in the 200-mg group.
At the end of treatment, ALP levels had dropped by an average of 63% in the 200-mg MBX-8025 group, 53% in the 50-mg group, and 2% in the placebo group (P less than .0001 for each dose effect versus placebo). Percent decreases in gamma-glutamyl transferase averaged 43% for both dose groups and 3% in the placebo group. Median levels of 7-alpha-hydroxy-4-cholesten-3-one, a marker of bile acid synthesis, fell by 77% in the 200-mg group and by 55% in the 50-mg group, but rose by 29% in the placebo group. Both the 50-mg and the 200-mg doses yielded statistically similar effects on all three cholestatic markers.
Although MBX-8025 did not appear to cause or worsen pruritus, 3 of the 35 patients developed rapid, asymptomatic, grade 3 increases in serum levels of alanine aminotransferase, the researchers reported. Two patients were taking 200 mg MBX-8025, and one was taking 50 mg. The effect fully reversed after patients stopped treatment, and was not associated with hyperbilirubinemia. Another patient in the 200-mg group stopped treatment because of what the investigators called “a muscle adverse event [that we] considered drug-related.”
The trial was halted halfway through recruitment, having established proof of concept, the investigators concluded. Because MBX-8025 is primarily excreted in bile, and primary biliary cholangitis obstructs bile flow, affected patients might have had more hepatic exposure to the agent than did those in previous trials, and this might explain the new safety signal, they noted.
CymaBay Therapeutics makes MBX-8025 and funded the trial. Dr. Jones disclosed ties to Intercept, GlaxoSmithKline, Novartis, and Falk. Eight coinvestigators disclosed employment with or other ties to CymaBay Therapeutics. The other three coinvestigators had no relevant disclosures.
FROM THE LIVER MEETING 2016
Key clinical point: In patients with primary biliary cholangitis, the investigational agent MBX-8025 was associated with significant decreases in cholestatic markers, but also with grade 3 increases in serum levels of alanine aminotransferase (ALT).
Major finding: At the end of treatment, alkaline phosphatase levels had dropped by 63% and by 53% in the 200-mg and 50-mg groups, respectively, and by 2% in the placebo group (P less than .0001). Three patients developed fully reversible grade 3 ALT increases.
Data source: A 12-week, double-blind, phase II trial of 35 patients with primary biliary cholangitis who had responded inadequately to ursodeoxycholic acid (NCT02609048).
Disclosures: CymaBay Therapeutics makes MBX-8025 and funded the trial. Dr. Jones disclosed ties to Intercept, GlaxoSmithKline, Novartis, and Falk. Eight coinvestigators disclosed employment with or other ties to CymaBay Therapeutics. The other three researchers had no relevant disclosures.
Thermal ablation of duodenal tissue lowers transaminases
BOSTON – An endoscopic procedure that heats and ablates a few centimeters of the surface of the duodenum reduced hepatic transaminases in patients with type 2 diabetes. According to an abstract released in advance of the annual meeting of the American Association for the Study of Liver Diseases , a reduction in transaminases was also seen in a subset of patients who had ultrasonographic evidence of hepatic steatosis.
The meeting presentation will focus on the results of two studies of patients with type 2 diabetes who received duodenal mucosal resurfacing (DMR) to about 9 circumferential cm of their duodenum. The first study, which was a single-site study of 30 patients, was the first human study of DMR. The second study was a multicenter study of 22 patients.
“A single duodenal mucosal resurfacing procedure resulted in a decrease of liver transaminases sustained for 12 months,” Annieke van Baar, an MD-PhD candidate in gastroenterology and hepatology at the Academic University Center, Amsterdam, wrote in the study abstract.
At 6 months after the one-time procedure, the composite cohort of patients in both studies saw a 25% reduction in alanine transaminase, with an absolute reduction of a mean 9.9 plus or minus 22.3 IU/mL. Mean aspartate transaminase also decreased by a mean of 21%, with absolute reduction of a mean 6.1 plus or minus 14.8 IU/mL.
For the subset of 23 patients in the composite cohort who had ultrasound-identified steatosis, AST decreased by 14.4 plus or minus 23 IU/mL at 6 months post procedure; the reduction from baseline was 7.6 plus or minus 9.8 IU/mL at 9 months.
Duodenal mucosal resurfacing, performed endoscopically as a day procedure, has been shown to improve metabolic markers for type 2 diabetes. Though the exact mechanism for improvement is not known, reduction in incretin and other hormonal signaling from the duodenum is thought to increase insulin sensitization.
Patient characteristics were similar in both studies, with a mean age of 52.8 years in the first study and 56.8 in the second. Mean body mass index was 32 kg/m2 in both studies. In the first study, mean baseline hemoglobin A1c (HbA1c) was 9.7%; HbA1c was 8.4% in the second study.
Both study groups saw significant reductions in HbA1c at 6 months post DMR, with reductions of 1.2 plus or minus 1.8% and 0.8 plus or minus 0.9% (P less than .001). Homeostatic model assessment of insulin resistance (HOMA-IR) was reduced after DMR as well, with reductions of 0.9 plus or minus 4, and 2.4 plus or minus 6.8 in the two study groups, though the decrease was not statistically significant.
The transaminase reductions and improved glycemic markers were not accompanied by significant weight loss: Patients lost a mean 1.8 plus or minus 3.6 kg in the first study, and 2.4 plus or minus 3.8 kg in the second study.
“This unique endoscopic intervention deserves further study to ascertain its potential efficacy as a treatment for fatty liver disease,” wrote Ms. van Baar and her coauthors.
The studies were funded by Fractyl Laboratories, the manufacturer of the DMR device. Ms. van Baar had no financial disclosures, but two coauthors reported relationships with Fractyl Laboratories, and another author disclosed relationships with multiple other pharmaceutical companies.
[email protected]
On Twitter @karioakes
BOSTON – An endoscopic procedure that heats and ablates a few centimeters of the surface of the duodenum reduced hepatic transaminases in patients with type 2 diabetes. According to an abstract released in advance of the annual meeting of the American Association for the Study of Liver Diseases , a reduction in transaminases was also seen in a subset of patients who had ultrasonographic evidence of hepatic steatosis.
The meeting presentation will focus on the results of two studies of patients with type 2 diabetes who received duodenal mucosal resurfacing (DMR) to about 9 circumferential cm of their duodenum. The first study, which was a single-site study of 30 patients, was the first human study of DMR. The second study was a multicenter study of 22 patients.
“A single duodenal mucosal resurfacing procedure resulted in a decrease of liver transaminases sustained for 12 months,” Annieke van Baar, an MD-PhD candidate in gastroenterology and hepatology at the Academic University Center, Amsterdam, wrote in the study abstract.
At 6 months after the one-time procedure, the composite cohort of patients in both studies saw a 25% reduction in alanine transaminase, with an absolute reduction of a mean 9.9 plus or minus 22.3 IU/mL. Mean aspartate transaminase also decreased by a mean of 21%, with absolute reduction of a mean 6.1 plus or minus 14.8 IU/mL.
For the subset of 23 patients in the composite cohort who had ultrasound-identified steatosis, AST decreased by 14.4 plus or minus 23 IU/mL at 6 months post procedure; the reduction from baseline was 7.6 plus or minus 9.8 IU/mL at 9 months.
Duodenal mucosal resurfacing, performed endoscopically as a day procedure, has been shown to improve metabolic markers for type 2 diabetes. Though the exact mechanism for improvement is not known, reduction in incretin and other hormonal signaling from the duodenum is thought to increase insulin sensitization.
Patient characteristics were similar in both studies, with a mean age of 52.8 years in the first study and 56.8 in the second. Mean body mass index was 32 kg/m2 in both studies. In the first study, mean baseline hemoglobin A1c (HbA1c) was 9.7%; HbA1c was 8.4% in the second study.
Both study groups saw significant reductions in HbA1c at 6 months post DMR, with reductions of 1.2 plus or minus 1.8% and 0.8 plus or minus 0.9% (P less than .001). Homeostatic model assessment of insulin resistance (HOMA-IR) was reduced after DMR as well, with reductions of 0.9 plus or minus 4, and 2.4 plus or minus 6.8 in the two study groups, though the decrease was not statistically significant.
The transaminase reductions and improved glycemic markers were not accompanied by significant weight loss: Patients lost a mean 1.8 plus or minus 3.6 kg in the first study, and 2.4 plus or minus 3.8 kg in the second study.
“This unique endoscopic intervention deserves further study to ascertain its potential efficacy as a treatment for fatty liver disease,” wrote Ms. van Baar and her coauthors.
The studies were funded by Fractyl Laboratories, the manufacturer of the DMR device. Ms. van Baar had no financial disclosures, but two coauthors reported relationships with Fractyl Laboratories, and another author disclosed relationships with multiple other pharmaceutical companies.
[email protected]
On Twitter @karioakes
BOSTON – An endoscopic procedure that heats and ablates a few centimeters of the surface of the duodenum reduced hepatic transaminases in patients with type 2 diabetes. According to an abstract released in advance of the annual meeting of the American Association for the Study of Liver Diseases , a reduction in transaminases was also seen in a subset of patients who had ultrasonographic evidence of hepatic steatosis.
The meeting presentation will focus on the results of two studies of patients with type 2 diabetes who received duodenal mucosal resurfacing (DMR) to about 9 circumferential cm of their duodenum. The first study, which was a single-site study of 30 patients, was the first human study of DMR. The second study was a multicenter study of 22 patients.
“A single duodenal mucosal resurfacing procedure resulted in a decrease of liver transaminases sustained for 12 months,” Annieke van Baar, an MD-PhD candidate in gastroenterology and hepatology at the Academic University Center, Amsterdam, wrote in the study abstract.
At 6 months after the one-time procedure, the composite cohort of patients in both studies saw a 25% reduction in alanine transaminase, with an absolute reduction of a mean 9.9 plus or minus 22.3 IU/mL. Mean aspartate transaminase also decreased by a mean of 21%, with absolute reduction of a mean 6.1 plus or minus 14.8 IU/mL.
For the subset of 23 patients in the composite cohort who had ultrasound-identified steatosis, AST decreased by 14.4 plus or minus 23 IU/mL at 6 months post procedure; the reduction from baseline was 7.6 plus or minus 9.8 IU/mL at 9 months.
Duodenal mucosal resurfacing, performed endoscopically as a day procedure, has been shown to improve metabolic markers for type 2 diabetes. Though the exact mechanism for improvement is not known, reduction in incretin and other hormonal signaling from the duodenum is thought to increase insulin sensitization.
Patient characteristics were similar in both studies, with a mean age of 52.8 years in the first study and 56.8 in the second. Mean body mass index was 32 kg/m2 in both studies. In the first study, mean baseline hemoglobin A1c (HbA1c) was 9.7%; HbA1c was 8.4% in the second study.
Both study groups saw significant reductions in HbA1c at 6 months post DMR, with reductions of 1.2 plus or minus 1.8% and 0.8 plus or minus 0.9% (P less than .001). Homeostatic model assessment of insulin resistance (HOMA-IR) was reduced after DMR as well, with reductions of 0.9 plus or minus 4, and 2.4 plus or minus 6.8 in the two study groups, though the decrease was not statistically significant.
The transaminase reductions and improved glycemic markers were not accompanied by significant weight loss: Patients lost a mean 1.8 plus or minus 3.6 kg in the first study, and 2.4 plus or minus 3.8 kg in the second study.
“This unique endoscopic intervention deserves further study to ascertain its potential efficacy as a treatment for fatty liver disease,” wrote Ms. van Baar and her coauthors.
The studies were funded by Fractyl Laboratories, the manufacturer of the DMR device. Ms. van Baar had no financial disclosures, but two coauthors reported relationships with Fractyl Laboratories, and another author disclosed relationships with multiple other pharmaceutical companies.
[email protected]
On Twitter @karioakes
FROM THE LIVER MEETING 2016
Liver transplant waits shorter with DAAs
The rate of wait-listing for liver transplants for patients with hepatitis C and decompensated cirrhosis has decreased by over 30% since the entry of direct-acting antiviral (DAA) therapy and now equals the wait-list rate for nonalcoholic steatohepatitis, according to an abstract of a study that will be presented at the annual meeting of the American Association for the Study of Liver Diseases.
Using the U.S. Scientific Registry of Transplant Recipients (SRTR), Jennifer Flemming, MD, and her coauthors developed a cohort of 47,591 adults who were wait-listed for liver transplant because of HCV or hepatitis B virus infection (HBV), or for nonalcoholic steatohepatitis (NASH).
Dr. Flemming, professor of gastroenterology at Queens University, Kingston, Ont., examined trends in liver transplant wait-listing between 2003 and 2015. The time period was divided into the “interferon era,” from 2003 to 2010, the “protease inhibitor era,” from 2011 to 2013, and the “DAA era,” from 2014 to 2015.
Examining annual standardized incidence rates of wait-listing, Dr. Flemming and her collaborators found that wait-listing for HCV patients with decompensated cirrhosis dropped by 5% during the protease inhibitor era, and by 32% in the DAA era (P = .004 and P less than .001, respectively).
Wait-listing for HBV also dropped, by 17% in the protease inhibitor era and by 24% in the DAA era (P = .002 and P less than .001, respectively). For NASH patients, conversely, wait-listing increased by 41% in the protease inhibitor era, and by 81% in the DAA era (P less than .001 for both). Hepatocellular carcinoma rates also rose during the protease inhibitor and DAA eras.
“Further reductions in [wait-listing] are anticipated with increased testing, linkage to care, and access to DAA therapy,” Dr. Flemming and her coauthors wrote in their study abstract.
Dr. Flemming reported no relevant financial disclosures. Several coauthors reported financial ties to pharmaceutical companies that market DAAs.
[email protected]
On Twitter @karioakes
The rate of wait-listing for liver transplants for patients with hepatitis C and decompensated cirrhosis has decreased by over 30% since the entry of direct-acting antiviral (DAA) therapy and now equals the wait-list rate for nonalcoholic steatohepatitis, according to an abstract of a study that will be presented at the annual meeting of the American Association for the Study of Liver Diseases.
Using the U.S. Scientific Registry of Transplant Recipients (SRTR), Jennifer Flemming, MD, and her coauthors developed a cohort of 47,591 adults who were wait-listed for liver transplant because of HCV or hepatitis B virus infection (HBV), or for nonalcoholic steatohepatitis (NASH).
Dr. Flemming, professor of gastroenterology at Queens University, Kingston, Ont., examined trends in liver transplant wait-listing between 2003 and 2015. The time period was divided into the “interferon era,” from 2003 to 2010, the “protease inhibitor era,” from 2011 to 2013, and the “DAA era,” from 2014 to 2015.
Examining annual standardized incidence rates of wait-listing, Dr. Flemming and her collaborators found that wait-listing for HCV patients with decompensated cirrhosis dropped by 5% during the protease inhibitor era, and by 32% in the DAA era (P = .004 and P less than .001, respectively).
Wait-listing for HBV also dropped, by 17% in the protease inhibitor era and by 24% in the DAA era (P = .002 and P less than .001, respectively). For NASH patients, conversely, wait-listing increased by 41% in the protease inhibitor era, and by 81% in the DAA era (P less than .001 for both). Hepatocellular carcinoma rates also rose during the protease inhibitor and DAA eras.
“Further reductions in [wait-listing] are anticipated with increased testing, linkage to care, and access to DAA therapy,” Dr. Flemming and her coauthors wrote in their study abstract.
Dr. Flemming reported no relevant financial disclosures. Several coauthors reported financial ties to pharmaceutical companies that market DAAs.
[email protected]
On Twitter @karioakes
The rate of wait-listing for liver transplants for patients with hepatitis C and decompensated cirrhosis has decreased by over 30% since the entry of direct-acting antiviral (DAA) therapy and now equals the wait-list rate for nonalcoholic steatohepatitis, according to an abstract of a study that will be presented at the annual meeting of the American Association for the Study of Liver Diseases.
Using the U.S. Scientific Registry of Transplant Recipients (SRTR), Jennifer Flemming, MD, and her coauthors developed a cohort of 47,591 adults who were wait-listed for liver transplant because of HCV or hepatitis B virus infection (HBV), or for nonalcoholic steatohepatitis (NASH).
Dr. Flemming, professor of gastroenterology at Queens University, Kingston, Ont., examined trends in liver transplant wait-listing between 2003 and 2015. The time period was divided into the “interferon era,” from 2003 to 2010, the “protease inhibitor era,” from 2011 to 2013, and the “DAA era,” from 2014 to 2015.
Examining annual standardized incidence rates of wait-listing, Dr. Flemming and her collaborators found that wait-listing for HCV patients with decompensated cirrhosis dropped by 5% during the protease inhibitor era, and by 32% in the DAA era (P = .004 and P less than .001, respectively).
Wait-listing for HBV also dropped, by 17% in the protease inhibitor era and by 24% in the DAA era (P = .002 and P less than .001, respectively). For NASH patients, conversely, wait-listing increased by 41% in the protease inhibitor era, and by 81% in the DAA era (P less than .001 for both). Hepatocellular carcinoma rates also rose during the protease inhibitor and DAA eras.
“Further reductions in [wait-listing] are anticipated with increased testing, linkage to care, and access to DAA therapy,” Dr. Flemming and her coauthors wrote in their study abstract.
Dr. Flemming reported no relevant financial disclosures. Several coauthors reported financial ties to pharmaceutical companies that market DAAs.
[email protected]
On Twitter @karioakes
FROM THE LIVER MEETING 2016
VIDEO: Recognizing the systemic impact of rosacea
LAS VEGAS – At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”
In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.
She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.
SDEF and this organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”
In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.
She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.
SDEF and this organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”
In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.
She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.
SDEF and this organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Goals of Care Infrequently Discussed among Hospitalized Long-Term Care Residents
Clinical Question: How often are goals of care (GOC) discussed during hospitalization of long-term care residents, and what patient characteristics make this more likely to occur?
Background: GOC discussions during hospitalization have the potential to better align patient wishes with care received and to reduce unwanted care. Previous studies have examined barriers to GOC discussions, but less is known about factors associated with GOC discussions occurring and the outcomes of these discussions.
Study Design: Retrospective chart review.
Setting: Two academic hospitals in Toronto.
Synopsis: In the review, 665 hospitalized patients during a one-year period were identified as being >65 years old and from a long-term care facility. Of the 665 patients, a random sampling of 200 unique patients was reviewed. Of these, 37.5% had a documented GOC discussion. Lower Glasgow Coma Scale scores and higher respiratory rates were correlated with a higher incidence of GOC discussions. Patients with GOC discussions had higher rates of no resuscitation and comfort care orders; these patients also had higher odds of in-hospital death and one-year mortality. Of patients that had a change in their GOC, 74% did not have this change reflected in the discharge summary.
Although this study is a retrospective review and limited to two Canadian teaching hospitals, there is likely an opportunity for hospitalists to more frequently discuss and document GOC in hospitalized long-term care patients.
Bottom Line: In hospitalized long-term care patients, GOC are infrequently discussed and documented. Frequency of discussions is correlated with illness severity.
Citation: Wong HJ, Wang J, Grinman M, Wu RC. Goals of care discussions among hospitalized long-term care residents: predictors and associated outcomes of care [published online ahead of print July 21, 2016]. J Hosp Med.
Short Take
Sleep-Promoting Interventions Improve Sleep in Hospitalized Patients
A non-blinded, quasi-randomized pilot study of 112 patients demonstrated that sleep-promoting interventions, including education and environmental control to minimize sleep disruption, improved total nighttime sleep time as well as qualitative measures of sleep.
Citation: Gathecha E, Rios R, Buenaver LF, Landis R, Howell E, Wright S. Pilot study aiming to support sleep quality and duration during hospitalizations. J Hosp Med. 2016;11(7):467-472.
Clinical Question: How often are goals of care (GOC) discussed during hospitalization of long-term care residents, and what patient characteristics make this more likely to occur?
Background: GOC discussions during hospitalization have the potential to better align patient wishes with care received and to reduce unwanted care. Previous studies have examined barriers to GOC discussions, but less is known about factors associated with GOC discussions occurring and the outcomes of these discussions.
Study Design: Retrospective chart review.
Setting: Two academic hospitals in Toronto.
Synopsis: In the review, 665 hospitalized patients during a one-year period were identified as being >65 years old and from a long-term care facility. Of the 665 patients, a random sampling of 200 unique patients was reviewed. Of these, 37.5% had a documented GOC discussion. Lower Glasgow Coma Scale scores and higher respiratory rates were correlated with a higher incidence of GOC discussions. Patients with GOC discussions had higher rates of no resuscitation and comfort care orders; these patients also had higher odds of in-hospital death and one-year mortality. Of patients that had a change in their GOC, 74% did not have this change reflected in the discharge summary.
Although this study is a retrospective review and limited to two Canadian teaching hospitals, there is likely an opportunity for hospitalists to more frequently discuss and document GOC in hospitalized long-term care patients.
Bottom Line: In hospitalized long-term care patients, GOC are infrequently discussed and documented. Frequency of discussions is correlated with illness severity.
Citation: Wong HJ, Wang J, Grinman M, Wu RC. Goals of care discussions among hospitalized long-term care residents: predictors and associated outcomes of care [published online ahead of print July 21, 2016]. J Hosp Med.
Short Take
Sleep-Promoting Interventions Improve Sleep in Hospitalized Patients
A non-blinded, quasi-randomized pilot study of 112 patients demonstrated that sleep-promoting interventions, including education and environmental control to minimize sleep disruption, improved total nighttime sleep time as well as qualitative measures of sleep.
Citation: Gathecha E, Rios R, Buenaver LF, Landis R, Howell E, Wright S. Pilot study aiming to support sleep quality and duration during hospitalizations. J Hosp Med. 2016;11(7):467-472.
Clinical Question: How often are goals of care (GOC) discussed during hospitalization of long-term care residents, and what patient characteristics make this more likely to occur?
Background: GOC discussions during hospitalization have the potential to better align patient wishes with care received and to reduce unwanted care. Previous studies have examined barriers to GOC discussions, but less is known about factors associated with GOC discussions occurring and the outcomes of these discussions.
Study Design: Retrospective chart review.
Setting: Two academic hospitals in Toronto.
Synopsis: In the review, 665 hospitalized patients during a one-year period were identified as being >65 years old and from a long-term care facility. Of the 665 patients, a random sampling of 200 unique patients was reviewed. Of these, 37.5% had a documented GOC discussion. Lower Glasgow Coma Scale scores and higher respiratory rates were correlated with a higher incidence of GOC discussions. Patients with GOC discussions had higher rates of no resuscitation and comfort care orders; these patients also had higher odds of in-hospital death and one-year mortality. Of patients that had a change in their GOC, 74% did not have this change reflected in the discharge summary.
Although this study is a retrospective review and limited to two Canadian teaching hospitals, there is likely an opportunity for hospitalists to more frequently discuss and document GOC in hospitalized long-term care patients.
Bottom Line: In hospitalized long-term care patients, GOC are infrequently discussed and documented. Frequency of discussions is correlated with illness severity.
Citation: Wong HJ, Wang J, Grinman M, Wu RC. Goals of care discussions among hospitalized long-term care residents: predictors and associated outcomes of care [published online ahead of print July 21, 2016]. J Hosp Med.
Short Take
Sleep-Promoting Interventions Improve Sleep in Hospitalized Patients
A non-blinded, quasi-randomized pilot study of 112 patients demonstrated that sleep-promoting interventions, including education and environmental control to minimize sleep disruption, improved total nighttime sleep time as well as qualitative measures of sleep.
Citation: Gathecha E, Rios R, Buenaver LF, Landis R, Howell E, Wright S. Pilot study aiming to support sleep quality and duration during hospitalizations. J Hosp Med. 2016;11(7):467-472.
Quality of End-of-Life Care Varies by Disease
Clinical Question: How do patterns of end-of-life care compare for patients with different diseases?
Background: Studies regarding quality of care at the end of life have focused primarily on patients dying from cancer. Few studies to date have looked at patients dying from other illnesses, and few have taken into account perspectives of family members.
Study Design: Retrospective cross-sectional.
Setting: 146 inpatient facilities in the Veterans Affairs (VA) health system.
Synopsis: The authors identified 57,753 patients who died while hospitalized at VA facilities during the study period, and 34,015 next of kin completed the Bereaved Family Survey. Overall, approximately half (43.7%–50.4%) of patients with end-stage renal disease (ESRD), frailty, or cardiopulmonary disease received palliative-care consultations compared with 73.5% and 61.4% of patients with cancer and dementia, respectively. Patients with cancer or dementia were less likely to die in the ICU compared to patients with other diagnoses (8.9%–13.4% compared to 32.3%–35.2%). Quality of care as perceived by the bereaved families was higher for patients with cancer or dementia (59.2%–59.3% compared to 53.7%–54.8%).
While large, this study was limited in applicability to different populations due to being conducted within the VA system. Overall, it showed significant differences in end-of-life care between patients who died from different diseases. This study suggests several practical steps that may improve disparities in end-of-life care, in particular, increasing discussion of goals of care and improving access to inpatient palliative-care consults for patients with ESRD, frailty, or cardiopulmonary disease.
Bottom Line: Quality and satisfaction indicators for end-of-life care for patients with ESRD, frailty, or cardiopulmonary disease were lower than for patients with dementia or cancer.
Citation: Wachterman MW, Pilver C, Smith D, Ersek M, Lipsitz SR, Keating NL. Quality of end-of-life care provided to patients with different serious illnesses. JAMA Intern Med. 2016;176(8):1095-1102.
Clinical Question: How do patterns of end-of-life care compare for patients with different diseases?
Background: Studies regarding quality of care at the end of life have focused primarily on patients dying from cancer. Few studies to date have looked at patients dying from other illnesses, and few have taken into account perspectives of family members.
Study Design: Retrospective cross-sectional.
Setting: 146 inpatient facilities in the Veterans Affairs (VA) health system.
Synopsis: The authors identified 57,753 patients who died while hospitalized at VA facilities during the study period, and 34,015 next of kin completed the Bereaved Family Survey. Overall, approximately half (43.7%–50.4%) of patients with end-stage renal disease (ESRD), frailty, or cardiopulmonary disease received palliative-care consultations compared with 73.5% and 61.4% of patients with cancer and dementia, respectively. Patients with cancer or dementia were less likely to die in the ICU compared to patients with other diagnoses (8.9%–13.4% compared to 32.3%–35.2%). Quality of care as perceived by the bereaved families was higher for patients with cancer or dementia (59.2%–59.3% compared to 53.7%–54.8%).
While large, this study was limited in applicability to different populations due to being conducted within the VA system. Overall, it showed significant differences in end-of-life care between patients who died from different diseases. This study suggests several practical steps that may improve disparities in end-of-life care, in particular, increasing discussion of goals of care and improving access to inpatient palliative-care consults for patients with ESRD, frailty, or cardiopulmonary disease.
Bottom Line: Quality and satisfaction indicators for end-of-life care for patients with ESRD, frailty, or cardiopulmonary disease were lower than for patients with dementia or cancer.
Citation: Wachterman MW, Pilver C, Smith D, Ersek M, Lipsitz SR, Keating NL. Quality of end-of-life care provided to patients with different serious illnesses. JAMA Intern Med. 2016;176(8):1095-1102.
Clinical Question: How do patterns of end-of-life care compare for patients with different diseases?
Background: Studies regarding quality of care at the end of life have focused primarily on patients dying from cancer. Few studies to date have looked at patients dying from other illnesses, and few have taken into account perspectives of family members.
Study Design: Retrospective cross-sectional.
Setting: 146 inpatient facilities in the Veterans Affairs (VA) health system.
Synopsis: The authors identified 57,753 patients who died while hospitalized at VA facilities during the study period, and 34,015 next of kin completed the Bereaved Family Survey. Overall, approximately half (43.7%–50.4%) of patients with end-stage renal disease (ESRD), frailty, or cardiopulmonary disease received palliative-care consultations compared with 73.5% and 61.4% of patients with cancer and dementia, respectively. Patients with cancer or dementia were less likely to die in the ICU compared to patients with other diagnoses (8.9%–13.4% compared to 32.3%–35.2%). Quality of care as perceived by the bereaved families was higher for patients with cancer or dementia (59.2%–59.3% compared to 53.7%–54.8%).
While large, this study was limited in applicability to different populations due to being conducted within the VA system. Overall, it showed significant differences in end-of-life care between patients who died from different diseases. This study suggests several practical steps that may improve disparities in end-of-life care, in particular, increasing discussion of goals of care and improving access to inpatient palliative-care consults for patients with ESRD, frailty, or cardiopulmonary disease.
Bottom Line: Quality and satisfaction indicators for end-of-life care for patients with ESRD, frailty, or cardiopulmonary disease were lower than for patients with dementia or cancer.
Citation: Wachterman MW, Pilver C, Smith D, Ersek M, Lipsitz SR, Keating NL. Quality of end-of-life care provided to patients with different serious illnesses. JAMA Intern Med. 2016;176(8):1095-1102.