Image by Spencer Phillips

GLASGOW—New research suggests the gene therapy SPK-9001 can reduce bleeding and the need for factor IX infusions in patients with hemophilia B.

In an ongoing, phase 1/2 trial, SPK-9001 reduced the annualized bleeding rate (ABR) by 98% and the annualized infusion rate (AIR) by 99%.

All 15 patients treated with SPK-9001 have discontinued factor IX prophylaxis.

There have been no serious adverse events (AEs), no thrombotic events, and no factor IX inhibitors observed to date.

Spencer K. Sullivan, MD, of the Mississippi Center for Advanced Medicine in Madison, Mississippi, presented these results at the World Federation of Hemophilia (WFH) 2018 World Congress during the “Free Papers: Gene Therapy” session on Tuesday.

The research was sponsored by Spark Therapeutics, the company developing SPK-9001 in collaboration with Pfizer.

SPK-9001 is an investigational vector that contains a bio-engineered adeno-associated virus capsid and a codon-optimized, high-activity human factor IX gene enabling endogenous production of factor IX.

Dr Sullivan reported results with SPK-9001 in 15 patients with severe or moderately severe hemophilia B.

As of the May 7, 2018, data cutoff, there were 13 patients with at least 12 weeks of follow-up after SPK-9001 infusion, which is the length of time required to achieve steady-state factor IX activity levels. All 13 patients reached stable factor IX levels of more than 12%.

The range of steady-state factor IX activity level, beginning at 12 weeks through 52 weeks of follow-up for the first 10 patients infused, was 14.3% to 76.8%.

The next 3 patients were infused with SPK-9001 manufactured using an enhanced process and reached 12 or more weeks of follow-up. For these patients, the range of steady-state factor IX activity level was 38.1% to 54.5%.

The 2 remaining patients had only 5 weeks and 11 weeks of follow-up as of the cut-off date.

Based on individual participant history for the year prior to the study, the overall ABR for all 15 patients was reduced by 98% four weeks after SPK-9001 treatment.

The ABR was 0.2 bleeds per patient after SPK-9001, compared to an ABR of 8.9 before SPK-9001.

One patient experienced a bleeding event 4 or more weeks after SPK-9001 infusion.

The overall AIR was reduced by 99% (based on data after week 4) for all 15 patients. The AIR was 0.9 infusions per patient after SPK-9001, compared to 57.2 infusions before SPK-9001.

Six patients received factor IX infusions following SPK-9001 administration—2 for reported spontaneous bleeds, 2 prior to surgery, 1 at the end of the study (discretionary, per protocol), and 1 for prophylaxis for a minor, traumatic non-bleeding event.

However, all 15 patients have discontinued regular factor IX prophylaxis.

There have been no serious AEs or factor IX inhibitors reported.

Two patients (1 who received SPK-9001 manufactured using the enhanced process) experienced related AEs of elevated transaminases, which were asymptomatic.

These patients were treated with a tapering course of oral corticosteroids, and 1 event resolved before the data cutoff.

An additional patient received a tapering course of oral corticosteroids for an increase in liver enzymes (not exceeding the upper limit of normal) temporally associated with falling levels of factor IX activity.

“We are pleased to see all 15 participants, notably including the first 4 participants who have been followed for more than 2 years, continue to show that a single administration of SPK-9001 has resulted in dramatic reductions in bleeding and factor IX infusions, with no serious adverse events,” said Katherine A. High, MD, president and head of research & development at Spark Therapeutics.

“Our commitment to gene therapy research across our hemophilia programs remains steadfast with the goal of developing a novel therapeutic approach with a positive benefit-risk profile that aims to free patients of the need for regular infusions, while eliminating spontaneous bleeding.”

Image by Spencer Phillips

GLASGOW—New research suggests the gene therapy SPK-9001 can reduce bleeding and the need for factor IX infusions in patients with hemophilia B.

In an ongoing, phase 1/2 trial, SPK-9001 reduced the annualized bleeding rate (ABR) by 98% and the annualized infusion rate (AIR) by 99%.

All 15 patients treated with SPK-9001 have discontinued factor IX prophylaxis.

There have been no serious adverse events (AEs), no thrombotic events, and no factor IX inhibitors observed to date.

Spencer K. Sullivan, MD, of the Mississippi Center for Advanced Medicine in Madison, Mississippi, presented these results at the World Federation of Hemophilia (WFH) 2018 World Congress during the “Free Papers: Gene Therapy” session on Tuesday.

The research was sponsored by Spark Therapeutics, the company developing SPK-9001 in collaboration with Pfizer.

SPK-9001 is an investigational vector that contains a bio-engineered adeno-associated virus capsid and a codon-optimized, high-activity human factor IX gene enabling endogenous production of factor IX.

Dr Sullivan reported results with SPK-9001 in 15 patients with severe or moderately severe hemophilia B.

As of the May 7, 2018, data cutoff, there were 13 patients with at least 12 weeks of follow-up after SPK-9001 infusion, which is the length of time required to achieve steady-state factor IX activity levels. All 13 patients reached stable factor IX levels of more than 12%.

The range of steady-state factor IX activity level, beginning at 12 weeks through 52 weeks of follow-up for the first 10 patients infused, was 14.3% to 76.8%.

The next 3 patients were infused with SPK-9001 manufactured using an enhanced process and reached 12 or more weeks of follow-up. For these patients, the range of steady-state factor IX activity level was 38.1% to 54.5%.

The 2 remaining patients had only 5 weeks and 11 weeks of follow-up as of the cut-off date.

Based on individual participant history for the year prior to the study, the overall ABR for all 15 patients was reduced by 98% four weeks after SPK-9001 treatment.

The ABR was 0.2 bleeds per patient after SPK-9001, compared to an ABR of 8.9 before SPK-9001.

One patient experienced a bleeding event 4 or more weeks after SPK-9001 infusion.

The overall AIR was reduced by 99% (based on data after week 4) for all 15 patients. The AIR was 0.9 infusions per patient after SPK-9001, compared to 57.2 infusions before SPK-9001.

Six patients received factor IX infusions following SPK-9001 administration—2 for reported spontaneous bleeds, 2 prior to surgery, 1 at the end of the study (discretionary, per protocol), and 1 for prophylaxis for a minor, traumatic non-bleeding event.

However, all 15 patients have discontinued regular factor IX prophylaxis.

There have been no serious AEs or factor IX inhibitors reported.

Two patients (1 who received SPK-9001 manufactured using the enhanced process) experienced related AEs of elevated transaminases, which were asymptomatic.

These patients were treated with a tapering course of oral corticosteroids, and 1 event resolved before the data cutoff.

An additional patient received a tapering course of oral corticosteroids for an increase in liver enzymes (not exceeding the upper limit of normal) temporally associated with falling levels of factor IX activity.

“We are pleased to see all 15 participants, notably including the first 4 participants who have been followed for more than 2 years, continue to show that a single administration of SPK-9001 has resulted in dramatic reductions in bleeding and factor IX infusions, with no serious adverse events,” said Katherine A. High, MD, president and head of research & development at Spark Therapeutics.

“Our commitment to gene therapy research across our hemophilia programs remains steadfast with the goal of developing a novel therapeutic approach with a positive benefit-risk profile that aims to free patients of the need for regular infusions, while eliminating spontaneous bleeding.”

Image by Spencer Phillips

GLASGOW—New research suggests the gene therapy SPK-9001 can reduce bleeding and the need for factor IX infusions in patients with hemophilia B.

In an ongoing, phase 1/2 trial, SPK-9001 reduced the annualized bleeding rate (ABR) by 98% and the annualized infusion rate (AIR) by 99%.

All 15 patients treated with SPK-9001 have discontinued factor IX prophylaxis.

There have been no serious adverse events (AEs), no thrombotic events, and no factor IX inhibitors observed to date.

Spencer K. Sullivan, MD, of the Mississippi Center for Advanced Medicine in Madison, Mississippi, presented these results at the World Federation of Hemophilia (WFH) 2018 World Congress during the “Free Papers: Gene Therapy” session on Tuesday.

The research was sponsored by Spark Therapeutics, the company developing SPK-9001 in collaboration with Pfizer.

SPK-9001 is an investigational vector that contains a bio-engineered adeno-associated virus capsid and a codon-optimized, high-activity human factor IX gene enabling endogenous production of factor IX.

Dr Sullivan reported results with SPK-9001 in 15 patients with severe or moderately severe hemophilia B.

As of the May 7, 2018, data cutoff, there were 13 patients with at least 12 weeks of follow-up after SPK-9001 infusion, which is the length of time required to achieve steady-state factor IX activity levels. All 13 patients reached stable factor IX levels of more than 12%.

The range of steady-state factor IX activity level, beginning at 12 weeks through 52 weeks of follow-up for the first 10 patients infused, was 14.3% to 76.8%.

The next 3 patients were infused with SPK-9001 manufactured using an enhanced process and reached 12 or more weeks of follow-up. For these patients, the range of steady-state factor IX activity level was 38.1% to 54.5%.

The 2 remaining patients had only 5 weeks and 11 weeks of follow-up as of the cut-off date.

Based on individual participant history for the year prior to the study, the overall ABR for all 15 patients was reduced by 98% four weeks after SPK-9001 treatment.

The ABR was 0.2 bleeds per patient after SPK-9001, compared to an ABR of 8.9 before SPK-9001.

One patient experienced a bleeding event 4 or more weeks after SPK-9001 infusion.

The overall AIR was reduced by 99% (based on data after week 4) for all 15 patients. The AIR was 0.9 infusions per patient after SPK-9001, compared to 57.2 infusions before SPK-9001.

Six patients received factor IX infusions following SPK-9001 administration—2 for reported spontaneous bleeds, 2 prior to surgery, 1 at the end of the study (discretionary, per protocol), and 1 for prophylaxis for a minor, traumatic non-bleeding event.

However, all 15 patients have discontinued regular factor IX prophylaxis.

There have been no serious AEs or factor IX inhibitors reported.

Two patients (1 who received SPK-9001 manufactured using the enhanced process) experienced related AEs of elevated transaminases, which were asymptomatic.

These patients were treated with a tapering course of oral corticosteroids, and 1 event resolved before the data cutoff.

An additional patient received a tapering course of oral corticosteroids for an increase in liver enzymes (not exceeding the upper limit of normal) temporally associated with falling levels of factor IX activity.

“We are pleased to see all 15 participants, notably including the first 4 participants who have been followed for more than 2 years, continue to show that a single administration of SPK-9001 has resulted in dramatic reductions in bleeding and factor IX infusions, with no serious adverse events,” said Katherine A. High, MD, president and head of research & development at Spark Therapeutics.

“Our commitment to gene therapy research across our hemophilia programs remains steadfast with the goal of developing a novel therapeutic approach with a positive benefit-risk profile that aims to free patients of the need for regular infusions, while eliminating spontaneous bleeding.”

Photo from Novo Nordisk

GLASGOW—Nonacog beta pegol (N9-GP) has a better pharmacokinetic (PK) profile than recombinant factor IX-Fc fusion protein (rFIXFc), according to researchers.

In a phase 1 trial, adults with hemophilia B who received a single dose of N9-GP achieved greater total factor IX exposure than those treated with rFIXFc, and N9-GP had a longer half-life.

Seven days after injection, factor IX activity was 6-fold greater in patients treated with N9-GP than in those treated with rFIXFc at the same dose.

“As a clinician, I know first-hand how challenging it can be to help people living with hemophilia B reach their treatment goals and be adequately protected from bleeding,” said Carmen Escuriola Ettingshausen, MD, of Haemophilia Centre Rhein Main in Frankfurt-Mörfelden, Germany.

“These data will help us better understand the different treatment options and choose the appropriate treatment for each patient.”

Dr Ettingshausen presented the data at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The research was sponsored by Novo Nordisk A/S, the company marketing N9-GP (as Rebinyn or Refixia). N9-GP is an extended half-life factor IX molecule intended for replacement therapy in patients with hemophilia B.

In the Paradigm7 trial, researchers compared the PK profiles of N9-GP and rFIXFc (Alprolix).

Fifteen previously treated adult males with congenital hemophilia B (factor IX activity ≤2%) received single injections (50 IU/kg) of N9-GP and rFIXFc with at least 21 days between doses.

One patient was excluded from the analysis due to intake of a prohibited medication (an rFIXFc product that was not Alprolix). Two other patients were excluded from some analyses because they missed 2 PK time points.

The primary endpoint was dose-normalized area under the factor IX activity-time curve from 0 to infinity (AUC_0-inf,norm).

The estimated AUC_0-inf,norm (n=12) was significantly higher for N9-GP than rFIXFc—9656 IU*h/dL and 2199 IU*h/dL, respectively (ratio=4.39, P<0.0001).

There were significant differences for secondary endpoints as well.

The maximum factor IX activity dose-normalized to 50 IU/kg (n=14) was 91 IU/dL with N9-GP and 45 IU/dL with rFIXFc (ratio=2.02, P<0.001).

The incremental recovery at 30 minutes (n=14) was 1.7 (IU/dL)/(IU/kg) with N9-GP and 0.8 (IU/dL)/(IU/kg) with rFIXFc (ratio=2.20, P<0.001).

The terminal half-life (n=12) was 103.2 hours with N9-GP and 84.9 hours with rFIXFc (ratio=1.22, P<0.001).

The clearance (n=12) was 0.52 mL/h/kg with N9-GP and 2.25 mL/h/kg with rFIXFc (ratio=0.23, P<0.001).

The factor IX activity at 168 hours (n=12) was 19 IU/dL with N9-GP and 3 IU/dL with rFIXFc (ratio=5.80, P<0.001).

None of the patients developed inhibitors, and no safety concerns were identified, according to Novo Nordisk. The company did not provide additional safety information.

Photo from Novo Nordisk

GLASGOW—Nonacog beta pegol (N9-GP) has a better pharmacokinetic (PK) profile than recombinant factor IX-Fc fusion protein (rFIXFc), according to researchers.

In a phase 1 trial, adults with hemophilia B who received a single dose of N9-GP achieved greater total factor IX exposure than those treated with rFIXFc, and N9-GP had a longer half-life.

Seven days after injection, factor IX activity was 6-fold greater in patients treated with N9-GP than in those treated with rFIXFc at the same dose.

“As a clinician, I know first-hand how challenging it can be to help people living with hemophilia B reach their treatment goals and be adequately protected from bleeding,” said Carmen Escuriola Ettingshausen, MD, of Haemophilia Centre Rhein Main in Frankfurt-Mörfelden, Germany.

“These data will help us better understand the different treatment options and choose the appropriate treatment for each patient.”

Dr Ettingshausen presented the data at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The research was sponsored by Novo Nordisk A/S, the company marketing N9-GP (as Rebinyn or Refixia). N9-GP is an extended half-life factor IX molecule intended for replacement therapy in patients with hemophilia B.

In the Paradigm7 trial, researchers compared the PK profiles of N9-GP and rFIXFc (Alprolix).

Fifteen previously treated adult males with congenital hemophilia B (factor IX activity ≤2%) received single injections (50 IU/kg) of N9-GP and rFIXFc with at least 21 days between doses.

One patient was excluded from the analysis due to intake of a prohibited medication (an rFIXFc product that was not Alprolix). Two other patients were excluded from some analyses because they missed 2 PK time points.

The primary endpoint was dose-normalized area under the factor IX activity-time curve from 0 to infinity (AUC_0-inf,norm).

The estimated AUC_0-inf,norm (n=12) was significantly higher for N9-GP than rFIXFc—9656 IU*h/dL and 2199 IU*h/dL, respectively (ratio=4.39, P<0.0001).

There were significant differences for secondary endpoints as well.

The maximum factor IX activity dose-normalized to 50 IU/kg (n=14) was 91 IU/dL with N9-GP and 45 IU/dL with rFIXFc (ratio=2.02, P<0.001).

The incremental recovery at 30 minutes (n=14) was 1.7 (IU/dL)/(IU/kg) with N9-GP and 0.8 (IU/dL)/(IU/kg) with rFIXFc (ratio=2.20, P<0.001).

The terminal half-life (n=12) was 103.2 hours with N9-GP and 84.9 hours with rFIXFc (ratio=1.22, P<0.001).

The clearance (n=12) was 0.52 mL/h/kg with N9-GP and 2.25 mL/h/kg with rFIXFc (ratio=0.23, P<0.001).

The factor IX activity at 168 hours (n=12) was 19 IU/dL with N9-GP and 3 IU/dL with rFIXFc (ratio=5.80, P<0.001).

None of the patients developed inhibitors, and no safety concerns were identified, according to Novo Nordisk. The company did not provide additional safety information.

Photo from Novo Nordisk

GLASGOW—Nonacog beta pegol (N9-GP) has a better pharmacokinetic (PK) profile than recombinant factor IX-Fc fusion protein (rFIXFc), according to researchers.

In a phase 1 trial, adults with hemophilia B who received a single dose of N9-GP achieved greater total factor IX exposure than those treated with rFIXFc, and N9-GP had a longer half-life.

Seven days after injection, factor IX activity was 6-fold greater in patients treated with N9-GP than in those treated with rFIXFc at the same dose.

“As a clinician, I know first-hand how challenging it can be to help people living with hemophilia B reach their treatment goals and be adequately protected from bleeding,” said Carmen Escuriola Ettingshausen, MD, of Haemophilia Centre Rhein Main in Frankfurt-Mörfelden, Germany.

“These data will help us better understand the different treatment options and choose the appropriate treatment for each patient.”

Dr Ettingshausen presented the data at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The research was sponsored by Novo Nordisk A/S, the company marketing N9-GP (as Rebinyn or Refixia). N9-GP is an extended half-life factor IX molecule intended for replacement therapy in patients with hemophilia B.

In the Paradigm7 trial, researchers compared the PK profiles of N9-GP and rFIXFc (Alprolix).

Fifteen previously treated adult males with congenital hemophilia B (factor IX activity ≤2%) received single injections (50 IU/kg) of N9-GP and rFIXFc with at least 21 days between doses.

One patient was excluded from the analysis due to intake of a prohibited medication (an rFIXFc product that was not Alprolix). Two other patients were excluded from some analyses because they missed 2 PK time points.

The primary endpoint was dose-normalized area under the factor IX activity-time curve from 0 to infinity (AUC_0-inf,norm).

The estimated AUC_0-inf,norm (n=12) was significantly higher for N9-GP than rFIXFc—9656 IU*h/dL and 2199 IU*h/dL, respectively (ratio=4.39, P<0.0001).

There were significant differences for secondary endpoints as well.

The maximum factor IX activity dose-normalized to 50 IU/kg (n=14) was 91 IU/dL with N9-GP and 45 IU/dL with rFIXFc (ratio=2.02, P<0.001).

The incremental recovery at 30 minutes (n=14) was 1.7 (IU/dL)/(IU/kg) with N9-GP and 0.8 (IU/dL)/(IU/kg) with rFIXFc (ratio=2.20, P<0.001).

The terminal half-life (n=12) was 103.2 hours with N9-GP and 84.9 hours with rFIXFc (ratio=1.22, P<0.001).

The clearance (n=12) was 0.52 mL/h/kg with N9-GP and 2.25 mL/h/kg with rFIXFc (ratio=0.23, P<0.001).

The factor IX activity at 168 hours (n=12) was 19 IU/dL with N9-GP and 3 IU/dL with rFIXFc (ratio=5.80, P<0.001).

None of the patients developed inhibitors, and no safety concerns were identified, according to Novo Nordisk. The company did not provide additional safety information.

Antihemophilic factor

GLASGOW—Preliminary data suggest an investigational therapy can extend the half-life of factor VIII (FVIII) in patients with severe hemophilia A.

Researchers are testing the therapy, BIVV001, in a phase 1/2a trial and have reported results in 4 patients.

BIVV001 extended the half-life of FVIII to 37 hours, with an average FVIII activity of 5.6% at 7 days post-infusion.

“For decades, scientists have been trying to overcome the von Willebrand factor ceiling, which imposes a limit on the half-life of FVIII, and these data demonstrate that BIVV001 has finally broken through that ceiling,” said Joachim Fruebis, PhD, senior vice president of development at Bioverativ Inc.

Dr Fruebis presented these data at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The research was sponsored by Bioverativ, the company developing BIVV001.

BIVV001 (rFVIIIFc-VWF-XTEN) is a recombinant FVIII therapy that builds on Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to potentially extend its time in circulation.

In the phase 1/2a EXTEN-A trial, researchers are evaluating the safety and pharmacokinetics of BIVV001 in a low-dose and high-dose cohort of subjects, ages 18 to 65, who have severe hemophilia A.

In the data presented at the WFH World Congress, 4 adult males received a single dose of recombinant FVIII therapy (25 IU/kg) followed, after a washout period, by a single, low dose of BIVV001 (25 IU/kg).

Primary endpoints of this study include the occurrence of adverse events and the development of inhibitors.

No inhibitors have been detected, and BIBV001 was “generally well-tolerated,” according to Bioverativ. The company did not provide additional safety information.

BIVV001 extended the half-life of FVIII to 37 hours, which is an increase over the 13 hours seen with recombinant FVIII.

The average FVIII activity for the 4 subjects was 13.0% at 5 days and 5.6% at 7 days post-infusion.

“Importantly for the hemophilia community, the factor levels seen in this study are unparalleled in hemophilia A,” Dr Fruebis said, “and we are excited about the potential for BIVV001 to transform the treatment paradigm for patients and physicians.”

Antihemophilic factor

GLASGOW—Preliminary data suggest an investigational therapy can extend the half-life of factor VIII (FVIII) in patients with severe hemophilia A.

Researchers are testing the therapy, BIVV001, in a phase 1/2a trial and have reported results in 4 patients.

BIVV001 extended the half-life of FVIII to 37 hours, with an average FVIII activity of 5.6% at 7 days post-infusion.

“For decades, scientists have been trying to overcome the von Willebrand factor ceiling, which imposes a limit on the half-life of FVIII, and these data demonstrate that BIVV001 has finally broken through that ceiling,” said Joachim Fruebis, PhD, senior vice president of development at Bioverativ Inc.

Dr Fruebis presented these data at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The research was sponsored by Bioverativ, the company developing BIVV001.

BIVV001 (rFVIIIFc-VWF-XTEN) is a recombinant FVIII therapy that builds on Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to potentially extend its time in circulation.

In the phase 1/2a EXTEN-A trial, researchers are evaluating the safety and pharmacokinetics of BIVV001 in a low-dose and high-dose cohort of subjects, ages 18 to 65, who have severe hemophilia A.

In the data presented at the WFH World Congress, 4 adult males received a single dose of recombinant FVIII therapy (25 IU/kg) followed, after a washout period, by a single, low dose of BIVV001 (25 IU/kg).

Primary endpoints of this study include the occurrence of adverse events and the development of inhibitors.

No inhibitors have been detected, and BIBV001 was “generally well-tolerated,” according to Bioverativ. The company did not provide additional safety information.

BIVV001 extended the half-life of FVIII to 37 hours, which is an increase over the 13 hours seen with recombinant FVIII.

The average FVIII activity for the 4 subjects was 13.0% at 5 days and 5.6% at 7 days post-infusion.

“Importantly for the hemophilia community, the factor levels seen in this study are unparalleled in hemophilia A,” Dr Fruebis said, “and we are excited about the potential for BIVV001 to transform the treatment paradigm for patients and physicians.”

Antihemophilic factor

GLASGOW—Preliminary data suggest an investigational therapy can extend the half-life of factor VIII (FVIII) in patients with severe hemophilia A.

Researchers are testing the therapy, BIVV001, in a phase 1/2a trial and have reported results in 4 patients.

BIVV001 extended the half-life of FVIII to 37 hours, with an average FVIII activity of 5.6% at 7 days post-infusion.

“For decades, scientists have been trying to overcome the von Willebrand factor ceiling, which imposes a limit on the half-life of FVIII, and these data demonstrate that BIVV001 has finally broken through that ceiling,” said Joachim Fruebis, PhD, senior vice president of development at Bioverativ Inc.

Dr Fruebis presented these data at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The research was sponsored by Bioverativ, the company developing BIVV001.

BIVV001 (rFVIIIFc-VWF-XTEN) is a recombinant FVIII therapy that builds on Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to potentially extend its time in circulation.

In the phase 1/2a EXTEN-A trial, researchers are evaluating the safety and pharmacokinetics of BIVV001 in a low-dose and high-dose cohort of subjects, ages 18 to 65, who have severe hemophilia A.

In the data presented at the WFH World Congress, 4 adult males received a single dose of recombinant FVIII therapy (25 IU/kg) followed, after a washout period, by a single, low dose of BIVV001 (25 IU/kg).

Primary endpoints of this study include the occurrence of adverse events and the development of inhibitors.

No inhibitors have been detected, and BIBV001 was “generally well-tolerated,” according to Bioverativ. The company did not provide additional safety information.

BIVV001 extended the half-life of FVIII to 37 hours, which is an increase over the 13 hours seen with recombinant FVIII.

The average FVIII activity for the 4 subjects was 13.0% at 5 days and 5.6% at 7 days post-infusion.

“Importantly for the hemophilia community, the factor levels seen in this study are unparalleled in hemophilia A,” Dr Fruebis said, “and we are excited about the potential for BIVV001 to transform the treatment paradigm for patients and physicians.”

Clinical question: Does pharmacist-led medication reconciliation in the community after hospital discharge reduce health care utilization, readmission rates, ED visits, primary care visits, or primary care workload?

Background: Accurate medication reconciliation is essential to ensure safe transitions of care after hospital discharge. Studies have shown that harm from prescribed or omitted medications is higher after discharge and pharmacist-led medication reconciliation on discharge has been shown to improve clinical outcomes. The effect of medication reconciliation after discharge performed by primary care and community-based pharmacist is unclear.

Study design: A meta-analysis.

Setting: This meta-analysis included five randomized, controlled trials, six cohort studies, two pre- and postintervention studies performed in the United Kingdom and United States as well as one quality improvement project performed in Canada.

Synopsis: The studies included demonstrated that community-based pharmacists were more effective at identifying and resolving discrepancies, compared with usual care, but the clinical relevance was unclear. There was no evidence that this reduced readmission rates. Because of the the heterogeneity of the settings, methods, and data reporting in the included trials, no firm conclusion could be drawn regarding the impact on either ED visits and primary care burden, and no consistent evidence of benefit was found. The benefit in clinical outcomes seen in prior studies may be related to other interventions, including patient education, medication review, and improved communication with primary care physicians. This study aimed to specifically isolate the impact of postdischarge, pharmacist-led medication reconciliation, and further research is still needed to understand the clinical relevance of medication discrepancies and which pharmacist-led interventions are most important.

Bottom line: Community-based pharmacists can identify and resolve discrepancies while performing medication reconciliation after hospital discharge, but there is no conclusive benefit in clinical outcomes, such as readmission rates, health care utilization, and primary care visits.

Citation: McNab D et al. Systematic review and meta-analysis of the effectiveness of pharmacist-led medication reconciliation in the community after hospital discharge. BMJ Qual Saf. 2017 Dec 16. pii: bmjqs-2017-007087. doi: 10.1136/bmjqs-2017-007087.

Dr. Rao is a hospitalist at Denver Health Medical Center and an assistant professor of medicine at the University of Colorado at Denver, Aurora.

Clinical question: Does pharmacist-led medication reconciliation in the community after hospital discharge reduce health care utilization, readmission rates, ED visits, primary care visits, or primary care workload?

Background: Accurate medication reconciliation is essential to ensure safe transitions of care after hospital discharge. Studies have shown that harm from prescribed or omitted medications is higher after discharge and pharmacist-led medication reconciliation on discharge has been shown to improve clinical outcomes. The effect of medication reconciliation after discharge performed by primary care and community-based pharmacist is unclear.

Study design: A meta-analysis.

Setting: This meta-analysis included five randomized, controlled trials, six cohort studies, two pre- and postintervention studies performed in the United Kingdom and United States as well as one quality improvement project performed in Canada.

Synopsis: The studies included demonstrated that community-based pharmacists were more effective at identifying and resolving discrepancies, compared with usual care, but the clinical relevance was unclear. There was no evidence that this reduced readmission rates. Because of the the heterogeneity of the settings, methods, and data reporting in the included trials, no firm conclusion could be drawn regarding the impact on either ED visits and primary care burden, and no consistent evidence of benefit was found. The benefit in clinical outcomes seen in prior studies may be related to other interventions, including patient education, medication review, and improved communication with primary care physicians. This study aimed to specifically isolate the impact of postdischarge, pharmacist-led medication reconciliation, and further research is still needed to understand the clinical relevance of medication discrepancies and which pharmacist-led interventions are most important.

Bottom line: Community-based pharmacists can identify and resolve discrepancies while performing medication reconciliation after hospital discharge, but there is no conclusive benefit in clinical outcomes, such as readmission rates, health care utilization, and primary care visits.

Citation: McNab D et al. Systematic review and meta-analysis of the effectiveness of pharmacist-led medication reconciliation in the community after hospital discharge. BMJ Qual Saf. 2017 Dec 16. pii: bmjqs-2017-007087. doi: 10.1136/bmjqs-2017-007087.

Dr. Rao is a hospitalist at Denver Health Medical Center and an assistant professor of medicine at the University of Colorado at Denver, Aurora.

Clinical question: Does pharmacist-led medication reconciliation in the community after hospital discharge reduce health care utilization, readmission rates, ED visits, primary care visits, or primary care workload?

Background: Accurate medication reconciliation is essential to ensure safe transitions of care after hospital discharge. Studies have shown that harm from prescribed or omitted medications is higher after discharge and pharmacist-led medication reconciliation on discharge has been shown to improve clinical outcomes. The effect of medication reconciliation after discharge performed by primary care and community-based pharmacist is unclear.

Study design: A meta-analysis.

Setting: This meta-analysis included five randomized, controlled trials, six cohort studies, two pre- and postintervention studies performed in the United Kingdom and United States as well as one quality improvement project performed in Canada.

Synopsis: The studies included demonstrated that community-based pharmacists were more effective at identifying and resolving discrepancies, compared with usual care, but the clinical relevance was unclear. There was no evidence that this reduced readmission rates. Because of the the heterogeneity of the settings, methods, and data reporting in the included trials, no firm conclusion could be drawn regarding the impact on either ED visits and primary care burden, and no consistent evidence of benefit was found. The benefit in clinical outcomes seen in prior studies may be related to other interventions, including patient education, medication review, and improved communication with primary care physicians. This study aimed to specifically isolate the impact of postdischarge, pharmacist-led medication reconciliation, and further research is still needed to understand the clinical relevance of medication discrepancies and which pharmacist-led interventions are most important.

Bottom line: Community-based pharmacists can identify and resolve discrepancies while performing medication reconciliation after hospital discharge, but there is no conclusive benefit in clinical outcomes, such as readmission rates, health care utilization, and primary care visits.

Citation: McNab D et al. Systematic review and meta-analysis of the effectiveness of pharmacist-led medication reconciliation in the community after hospital discharge. BMJ Qual Saf. 2017 Dec 16. pii: bmjqs-2017-007087. doi: 10.1136/bmjqs-2017-007087.

Dr. Rao is a hospitalist at Denver Health Medical Center and an assistant professor of medicine at the University of Colorado at Denver, Aurora.

A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.

In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.

Thomas Northcut/Thinkstock

• 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.

• 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
• 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.

  

• 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
• 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and every time I walked past his ED bay, he’d yell, “Is this the face of a crazy man? I know the law!” I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.

• 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.

Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.

A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.

In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.

Thomas Northcut/Thinkstock

• 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.

• 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
• 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.

  

• 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
• 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and every time I walked past his ED bay, he’d yell, “Is this the face of a crazy man? I know the law!” I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.

• 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.

Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.

A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.

In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.

Thomas Northcut/Thinkstock

• 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.

• 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
• 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.

  

• 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
• 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and every time I walked past his ED bay, he’d yell, “Is this the face of a crazy man? I know the law!” I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.

• 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.

Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.

SAN DIEGO – About one in four intubated or mechanically ventilated patients with gram-negative pneumonia die during hospitalization, results from a large retrospective cohort study found.

In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.

XiXinXing/ThinkStock

In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.

A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.

They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.

Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.

[email protected]

SOURCE: Lodise T. et al. ATS 2018, Poster 272.

SAN DIEGO – About one in four intubated or mechanically ventilated patients with gram-negative pneumonia die during hospitalization, results from a large retrospective cohort study found.

In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.

XiXinXing/ThinkStock

In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.

A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.

They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.

Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.

[email protected]

SOURCE: Lodise T. et al. ATS 2018, Poster 272.

SAN DIEGO – About one in four intubated or mechanically ventilated patients with gram-negative pneumonia die during hospitalization, results from a large retrospective cohort study found.

In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.

XiXinXing/ThinkStock

In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.

A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.

They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.

Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.

[email protected]

SOURCE: Lodise T. et al. ATS 2018, Poster 272.

Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.

Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.

Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. Her strategy: People with serious mental illnesses and substance use disorders need prompt, evidence-based treatment for their illnesses before they can begin to heal.

It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?

It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.

“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”

In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.

In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.

[email protected]

Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.

Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.

Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. Her strategy: People with serious mental illnesses and substance use disorders need prompt, evidence-based treatment for their illnesses before they can begin to heal.

It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?

It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.

“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”

In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.

In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.

[email protected]

Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.

Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.

Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. Her strategy: People with serious mental illnesses and substance use disorders need prompt, evidence-based treatment for their illnesses before they can begin to heal.

It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?

It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.

“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”

In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.

In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.

[email protected]

Nearly 4% of Veterans Affairs patients who screened positive for unhealthy alcohol use were infected with hepatitis C virus, and 64% of these patients were diagnosed with alcohol use disorder, according to the results of a large database analysis.

Despite the fact that alcohol use at all levels can compound the adverse effects of HCV and lead to heightened risks of mortality, particularly among those coinfected with HIV, the majority of these patients did not receive specialty addiction treatment, according to Mandy D. Owens, PhD, and her colleagues at the VA Puget Sound Health Care System, Seattle.

Katarzyna Bialasiewicz/ThinkStock

In their study, published in Drug and Alcohol Dependence, the researchers queried the national VA health care system database, which is made up of 139 large facilities and more than 900 clinics throughout the United States, for all patients with a documented outpatient appointment between October 2009 and May 2013 to identify those with one or more with positive screens on the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) questionnaire. Those with AUDIT-C scores greater than or equal to 5 were considered positive, and each positive screen was tracked for up to 1 year to assess alcohol-related care outcomes. The four alcohol-related care outcomes measured were: receipt of brief intervention, specialty addiction treatment, alcohol use disorder (AUD) pharmacotherapy, and a composite measure of receiving any of these services.

Patients also were compared across HCV status in the entire sample of patients with positive screening as well as in the subsample with a clinically documented AUD.

During the study period, 830,825 VA patients screened positive for unhealthy alcohol use. Among those, 31,841 (3.8%) patients had a documented diagnosis for HCV, and of these 20,320 (64%) had an AUD. Two-thirds of these AUD patients did not receive specialty addiction treatment, and more than 90% did not receive pharmacotherapy that is approved by the Food and Drug Administration to treat AUD, according to the researchers. “These rates are concerning given the negative impact alcohol use can have on HCV,” they wrote.

They reiterated the importance of the 2016 change in policy adopted by the VA Health System, which updated its treatment guidelines to recommend that all patients with HCV be considered for treatment, regardless of substance use, and explicitly stated that alcohol use and length of abstinence should not be disqualifiers for receiving HCV treatment.

“All patients with HCV should be receiving evidence-based alcohol-related care given the risks of alcohol use in this population, particularly among those coinfected with HIV,” the researchers concluded.

The research was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism. The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Owens MD et al. Drug Alcohol Depend. 2018;188:79-85.

Nearly 4% of Veterans Affairs patients who screened positive for unhealthy alcohol use were infected with hepatitis C virus, and 64% of these patients were diagnosed with alcohol use disorder, according to the results of a large database analysis.

Despite the fact that alcohol use at all levels can compound the adverse effects of HCV and lead to heightened risks of mortality, particularly among those coinfected with HIV, the majority of these patients did not receive specialty addiction treatment, according to Mandy D. Owens, PhD, and her colleagues at the VA Puget Sound Health Care System, Seattle.

Katarzyna Bialasiewicz/ThinkStock

In their study, published in Drug and Alcohol Dependence, the researchers queried the national VA health care system database, which is made up of 139 large facilities and more than 900 clinics throughout the United States, for all patients with a documented outpatient appointment between October 2009 and May 2013 to identify those with one or more with positive screens on the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) questionnaire. Those with AUDIT-C scores greater than or equal to 5 were considered positive, and each positive screen was tracked for up to 1 year to assess alcohol-related care outcomes. The four alcohol-related care outcomes measured were: receipt of brief intervention, specialty addiction treatment, alcohol use disorder (AUD) pharmacotherapy, and a composite measure of receiving any of these services.

Patients also were compared across HCV status in the entire sample of patients with positive screening as well as in the subsample with a clinically documented AUD.

During the study period, 830,825 VA patients screened positive for unhealthy alcohol use. Among those, 31,841 (3.8%) patients had a documented diagnosis for HCV, and of these 20,320 (64%) had an AUD. Two-thirds of these AUD patients did not receive specialty addiction treatment, and more than 90% did not receive pharmacotherapy that is approved by the Food and Drug Administration to treat AUD, according to the researchers. “These rates are concerning given the negative impact alcohol use can have on HCV,” they wrote.

They reiterated the importance of the 2016 change in policy adopted by the VA Health System, which updated its treatment guidelines to recommend that all patients with HCV be considered for treatment, regardless of substance use, and explicitly stated that alcohol use and length of abstinence should not be disqualifiers for receiving HCV treatment.

“All patients with HCV should be receiving evidence-based alcohol-related care given the risks of alcohol use in this population, particularly among those coinfected with HIV,” the researchers concluded.

The research was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism. The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Owens MD et al. Drug Alcohol Depend. 2018;188:79-85.

Nearly 4% of Veterans Affairs patients who screened positive for unhealthy alcohol use were infected with hepatitis C virus, and 64% of these patients were diagnosed with alcohol use disorder, according to the results of a large database analysis.

Despite the fact that alcohol use at all levels can compound the adverse effects of HCV and lead to heightened risks of mortality, particularly among those coinfected with HIV, the majority of these patients did not receive specialty addiction treatment, according to Mandy D. Owens, PhD, and her colleagues at the VA Puget Sound Health Care System, Seattle.

Katarzyna Bialasiewicz/ThinkStock

In their study, published in Drug and Alcohol Dependence, the researchers queried the national VA health care system database, which is made up of 139 large facilities and more than 900 clinics throughout the United States, for all patients with a documented outpatient appointment between October 2009 and May 2013 to identify those with one or more with positive screens on the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) questionnaire. Those with AUDIT-C scores greater than or equal to 5 were considered positive, and each positive screen was tracked for up to 1 year to assess alcohol-related care outcomes. The four alcohol-related care outcomes measured were: receipt of brief intervention, specialty addiction treatment, alcohol use disorder (AUD) pharmacotherapy, and a composite measure of receiving any of these services.

Patients also were compared across HCV status in the entire sample of patients with positive screening as well as in the subsample with a clinically documented AUD.

During the study period, 830,825 VA patients screened positive for unhealthy alcohol use. Among those, 31,841 (3.8%) patients had a documented diagnosis for HCV, and of these 20,320 (64%) had an AUD. Two-thirds of these AUD patients did not receive specialty addiction treatment, and more than 90% did not receive pharmacotherapy that is approved by the Food and Drug Administration to treat AUD, according to the researchers. “These rates are concerning given the negative impact alcohol use can have on HCV,” they wrote.

They reiterated the importance of the 2016 change in policy adopted by the VA Health System, which updated its treatment guidelines to recommend that all patients with HCV be considered for treatment, regardless of substance use, and explicitly stated that alcohol use and length of abstinence should not be disqualifiers for receiving HCV treatment.

“All patients with HCV should be receiving evidence-based alcohol-related care given the risks of alcohol use in this population, particularly among those coinfected with HIV,” the researchers concluded.

The research was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism. The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Owens MD et al. Drug Alcohol Depend. 2018;188:79-85.

The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!

AGA Institute Council 2018 Section Research Mentor Award recipients

Basic & Clinical Intestinal Disorders

Gary D. Wu, MD

Cellular & Molecular Gastroenterology

Charalabos Pothoulakis, MD

Clinical Practice

Amnon Sonnenberg, MD, MSc

Esophageal, Gastric & Duodenal Disorders

Nicholas J. Shaheen, MD, MPH, AGAF

Gastrointestinal Oncology

Randall W. Burt, MD, AGAF

Growth, Development & Child Health

Deborah L. Gumucio, PhD

Imaging, Endoscopy & Advanced Technology

Michael B. Wallace, MD, MPH, AGAF

Immunology, Microbiology & Inflammatory Bowel Diseases

Claudio Fiocchi, MD

Liver & Biliary

Scott L. Friedman, MD

Microbiome & Microbial Diseases in the Gastrointestinal Tract

Jeffrey I. Gordon, MD

Neurogastroenterology & Motility

Richard W. McCallum, MD, AGAF

Obesity, Metabolism & Nutrition

Lee M. Kaplan, MD, PhD, AGAF

Pancreatic Disorders

Suresh T. Chari, MD
 

[email protected]

The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!

AGA Institute Council 2018 Section Research Mentor Award recipients

Basic & Clinical Intestinal Disorders

Gary D. Wu, MD

Cellular & Molecular Gastroenterology

Charalabos Pothoulakis, MD

Clinical Practice

Amnon Sonnenberg, MD, MSc

Esophageal, Gastric & Duodenal Disorders

Nicholas J. Shaheen, MD, MPH, AGAF

Gastrointestinal Oncology

Randall W. Burt, MD, AGAF

Growth, Development & Child Health

Deborah L. Gumucio, PhD

Imaging, Endoscopy & Advanced Technology

Michael B. Wallace, MD, MPH, AGAF

Immunology, Microbiology & Inflammatory Bowel Diseases

Claudio Fiocchi, MD

Liver & Biliary

Scott L. Friedman, MD

Microbiome & Microbial Diseases in the Gastrointestinal Tract

Jeffrey I. Gordon, MD

Neurogastroenterology & Motility

Richard W. McCallum, MD, AGAF

Obesity, Metabolism & Nutrition

Lee M. Kaplan, MD, PhD, AGAF

Pancreatic Disorders

Suresh T. Chari, MD
 

[email protected]

The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!

AGA Institute Council 2018 Section Research Mentor Award recipients

Basic & Clinical Intestinal Disorders

Gary D. Wu, MD

Cellular & Molecular Gastroenterology

Charalabos Pothoulakis, MD

Clinical Practice

Amnon Sonnenberg, MD, MSc

Esophageal, Gastric & Duodenal Disorders

Nicholas J. Shaheen, MD, MPH, AGAF

Gastrointestinal Oncology

Randall W. Burt, MD, AGAF

Growth, Development & Child Health

Deborah L. Gumucio, PhD

Imaging, Endoscopy & Advanced Technology

Michael B. Wallace, MD, MPH, AGAF

Immunology, Microbiology & Inflammatory Bowel Diseases

Claudio Fiocchi, MD

Liver & Biliary

Scott L. Friedman, MD

Microbiome & Microbial Diseases in the Gastrointestinal Tract

Jeffrey I. Gordon, MD

Neurogastroenterology & Motility

Richard W. McCallum, MD, AGAF

Obesity, Metabolism & Nutrition

Lee M. Kaplan, MD, PhD, AGAF

Pancreatic Disorders

Suresh T. Chari, MD
 

[email protected]