No VTE prophylaxis needed after joint surgery in patients with hemophilia

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No VTE prophylaxis needed after joint surgery in patients with hemophilia

ORLANDO – In patients with hemophilia who have therapeutic factor levels at the time of joint replacement surgery, prophylaxis against venous thromboembolism (VTE) may be unnecessary.

In a cohort study of patients with hemophilia A or B who underwent total joint replacement surgery while being in proper hemostasis with therapeutic factor levels, there were no clinically evident episodes of venous thromboembolism, even though none of the patients had received perioperative anticoagulant prophylaxis, reported investigators from the National Hemophilia Center and Institute of Thrombosis and Hemostasis at the Sheba Medical Center in Tel Hashomer, Israel.

 

© pavlen/iStockphoto

The data should be reassuring to clinicians whose patients with hemophilia require major orthopedic procedures, said lead author Dr. Anna Seltser, an orthopedic resident at Sheba Medical Center, in an interview.

“We have a lot of hemophilia patients who are not well treated because they live in the desert or distant communities, and we also sometimes treat patients from the Palestinian side of the Gaza Strip who don’t have access to care and need this type of surgery,” she said.

“We collected what I think is the biggest series of patients until now, we didn’t give any of them VTE prophylaxis, and none of them had any DVT [deep vein thrombosis], PE [pulmonary embolism], or similar complication,” she said.

Skip the heparin?

VTE prophylaxis with low-molecular-weight heparin, warfarin, or other anticoagulant agents is a common practice following orthopedic surgery in patients without bleeding disorders. But for patients with severe hemophilia, who often require major joint replacement surgery following years of bleeding-induced arthropathy, it’s unclear whether perioperative anticoagulation is beneficial, the investigators noted in a scientific poster at the World Federation of Hemophilia World Congress.

Dr. Seltser and colleagues therefore conducted a prospective cohort study of 50 patients with hemophilia A or B treated with major joint surgery and subsequent revisions from 1988 through 2015 at their center. In all, 47 patients had severe hemophilia A, 2 had mild hemophilia A, and 1 had hemophilia B.

The authors analyzed data on demographics, comorbidities, type of surgery, use of factor concentrates therapy around the time of surgery, and complications during follow-up, including massive hemorrhage, infections, implant loosening, DVT, and PE.

The patients underwent a total of 74 primary joint replacements (16 hips, 52 knees, and 6 ankles) and 23 revision surgeries.

As noted, there were no episodes of either DVT or PE among any of the patients. All but one complication occurred among patients undergoing total knee replacement. These included three cases of hemarthrosis, three limited-range-of-motion cases requiring closed manipulations, four soft-tissue hematomas, and one case each of superficial wound infection, urinary tract infection, pneumonia, and Candida infection of the tongue.

The only other complication was a case of disseminated intravascular coagulation, sepsis, and hemorrhagic shock in a patient who had undergone a revision (original procedure unspecified).

“Despite the concern that proper replacement factor therapy, applied before and after the surgery, may increase the risk for thromboembolic complications in patients with hemophilia undergoing joint replacement, our data show that prophylactic anticoagulation in this group of patients is not necessary,” the investigators concluded.

The study was internally funded. The investigators reported no conflicts of interest.

[email protected]

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ORLANDO – In patients with hemophilia who have therapeutic factor levels at the time of joint replacement surgery, prophylaxis against venous thromboembolism (VTE) may be unnecessary.

In a cohort study of patients with hemophilia A or B who underwent total joint replacement surgery while being in proper hemostasis with therapeutic factor levels, there were no clinically evident episodes of venous thromboembolism, even though none of the patients had received perioperative anticoagulant prophylaxis, reported investigators from the National Hemophilia Center and Institute of Thrombosis and Hemostasis at the Sheba Medical Center in Tel Hashomer, Israel.

 

© pavlen/iStockphoto

The data should be reassuring to clinicians whose patients with hemophilia require major orthopedic procedures, said lead author Dr. Anna Seltser, an orthopedic resident at Sheba Medical Center, in an interview.

“We have a lot of hemophilia patients who are not well treated because they live in the desert or distant communities, and we also sometimes treat patients from the Palestinian side of the Gaza Strip who don’t have access to care and need this type of surgery,” she said.

“We collected what I think is the biggest series of patients until now, we didn’t give any of them VTE prophylaxis, and none of them had any DVT [deep vein thrombosis], PE [pulmonary embolism], or similar complication,” she said.

Skip the heparin?

VTE prophylaxis with low-molecular-weight heparin, warfarin, or other anticoagulant agents is a common practice following orthopedic surgery in patients without bleeding disorders. But for patients with severe hemophilia, who often require major joint replacement surgery following years of bleeding-induced arthropathy, it’s unclear whether perioperative anticoagulation is beneficial, the investigators noted in a scientific poster at the World Federation of Hemophilia World Congress.

Dr. Seltser and colleagues therefore conducted a prospective cohort study of 50 patients with hemophilia A or B treated with major joint surgery and subsequent revisions from 1988 through 2015 at their center. In all, 47 patients had severe hemophilia A, 2 had mild hemophilia A, and 1 had hemophilia B.

The authors analyzed data on demographics, comorbidities, type of surgery, use of factor concentrates therapy around the time of surgery, and complications during follow-up, including massive hemorrhage, infections, implant loosening, DVT, and PE.

The patients underwent a total of 74 primary joint replacements (16 hips, 52 knees, and 6 ankles) and 23 revision surgeries.

As noted, there were no episodes of either DVT or PE among any of the patients. All but one complication occurred among patients undergoing total knee replacement. These included three cases of hemarthrosis, three limited-range-of-motion cases requiring closed manipulations, four soft-tissue hematomas, and one case each of superficial wound infection, urinary tract infection, pneumonia, and Candida infection of the tongue.

The only other complication was a case of disseminated intravascular coagulation, sepsis, and hemorrhagic shock in a patient who had undergone a revision (original procedure unspecified).

“Despite the concern that proper replacement factor therapy, applied before and after the surgery, may increase the risk for thromboembolic complications in patients with hemophilia undergoing joint replacement, our data show that prophylactic anticoagulation in this group of patients is not necessary,” the investigators concluded.

The study was internally funded. The investigators reported no conflicts of interest.

[email protected]

ORLANDO – In patients with hemophilia who have therapeutic factor levels at the time of joint replacement surgery, prophylaxis against venous thromboembolism (VTE) may be unnecessary.

In a cohort study of patients with hemophilia A or B who underwent total joint replacement surgery while being in proper hemostasis with therapeutic factor levels, there were no clinically evident episodes of venous thromboembolism, even though none of the patients had received perioperative anticoagulant prophylaxis, reported investigators from the National Hemophilia Center and Institute of Thrombosis and Hemostasis at the Sheba Medical Center in Tel Hashomer, Israel.

 

© pavlen/iStockphoto

The data should be reassuring to clinicians whose patients with hemophilia require major orthopedic procedures, said lead author Dr. Anna Seltser, an orthopedic resident at Sheba Medical Center, in an interview.

“We have a lot of hemophilia patients who are not well treated because they live in the desert or distant communities, and we also sometimes treat patients from the Palestinian side of the Gaza Strip who don’t have access to care and need this type of surgery,” she said.

“We collected what I think is the biggest series of patients until now, we didn’t give any of them VTE prophylaxis, and none of them had any DVT [deep vein thrombosis], PE [pulmonary embolism], or similar complication,” she said.

Skip the heparin?

VTE prophylaxis with low-molecular-weight heparin, warfarin, or other anticoagulant agents is a common practice following orthopedic surgery in patients without bleeding disorders. But for patients with severe hemophilia, who often require major joint replacement surgery following years of bleeding-induced arthropathy, it’s unclear whether perioperative anticoagulation is beneficial, the investigators noted in a scientific poster at the World Federation of Hemophilia World Congress.

Dr. Seltser and colleagues therefore conducted a prospective cohort study of 50 patients with hemophilia A or B treated with major joint surgery and subsequent revisions from 1988 through 2015 at their center. In all, 47 patients had severe hemophilia A, 2 had mild hemophilia A, and 1 had hemophilia B.

The authors analyzed data on demographics, comorbidities, type of surgery, use of factor concentrates therapy around the time of surgery, and complications during follow-up, including massive hemorrhage, infections, implant loosening, DVT, and PE.

The patients underwent a total of 74 primary joint replacements (16 hips, 52 knees, and 6 ankles) and 23 revision surgeries.

As noted, there were no episodes of either DVT or PE among any of the patients. All but one complication occurred among patients undergoing total knee replacement. These included three cases of hemarthrosis, three limited-range-of-motion cases requiring closed manipulations, four soft-tissue hematomas, and one case each of superficial wound infection, urinary tract infection, pneumonia, and Candida infection of the tongue.

The only other complication was a case of disseminated intravascular coagulation, sepsis, and hemorrhagic shock in a patient who had undergone a revision (original procedure unspecified).

“Despite the concern that proper replacement factor therapy, applied before and after the surgery, may increase the risk for thromboembolic complications in patients with hemophilia undergoing joint replacement, our data show that prophylactic anticoagulation in this group of patients is not necessary,” the investigators concluded.

The study was internally funded. The investigators reported no conflicts of interest.

[email protected]

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Key clinical point: Prophylaxis against thromboembolic events after orthopedic surgery in patients with hemophilia may not be necessary.

Major finding: There were no thromboembolic events after joint surgery without anticoagulant prophylaxis in patients with hemophilia A or B.

Data source: Cohort study of 50 patients with hemophilia A or B undergoing major joint replacement surgery.

Disclosures: The study was internally funded. The investigators reported no conflicts of interest.

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CANDLE syndrome case highlights key features of this type 1 interferonopathy

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CANDLE syndrome case highlights key features of this type 1 interferonopathy

BOSTON – Annular erythematous plaques in a child with fever and dense, atypical, mixed mononuclear and neutrophilic dermal infiltrate on biopsy could signal the recently described autoinflammatory disorder known as CANDLE Syndrome, according to Raegan Hunt, MD.

CANDLE, which stands for chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature, is a proteasome-associated autoinflammatory syndrome characterized by dysregulation of type 1 interferon signaling, Dr. Hunt of Baylor College of Medicine and Texas Children’s Hospital said during a presentation at the American Academy of Dermatology summer meeting.

Dr. Raegan Hunt

She described a case involving a 12-year-old girl with erythematous, warm, tender, nonpruritic papules and plaques on the superior chest, neck, and upper back. Most had an annular configuration with central clearing and occasionally central duskiness and ulceration.

The child also sometimes had violaceous swelling of the eyelid, nodules on the ear, and figurate erythematous plaques on the upper arm.

“She’s been having these since she was an infant in periodic bursts, and carried a diagnosis of annular erythema of infancy,” Dr. Hunt said.

Other symptoms included recurrent fevers, myalgias, transient and migratory arthritis, elevated C-reactive protein and erythrocyte sedimentation rate, and aseptic meningitis requiring hospitalization.

She had no family history of autoimmune disease, immune deficiency, or other genetic diseases, Dr. Hunt said.

Courtesy Dr. Raegan Hunt
These are typical lesions of CANDLE syndrome.

“She was treated with methotrexate and prednisone, as well as IVIG [intravenous immunoglobulin] every 4 weeks. Her prednisone was never weaned successfully below 0.8 mg/kg. She had complications of chronic corticosteroid disease, including many fractures,” she said.

A biopsy showed a dense infiltrate of atypical, mixed mononuclear and neutrophilic dermal infiltrate.

“These taken together are suggestive of ... CANDLE,” she said.

Genetic testing confirmed the presence of a compound heterozygous mutation in the proteasome subunit beta type 9, or PSMB8 gene.

Key features of CANDLE syndrome, first described in a 2010 article and further described by Liu, et al in 2012, include early disease onset, recurrent febrile episodes, skin lesions – including recurrent attacks of erythematous annular plaques and violaceous swelling of the eyelids, delayed physical development, progressive lipodystrophy, arthralgias, systemic inflammation, and aseptic meningitis episodes.

“Our patient did have very, very subtle lipodystrophy, but overall not as quick onset as some other [cases in children] that have been described,” Dr. Hunt said.

The type 1 interferonopathy is of autosomal recessive inheritance, and involves either homozygous or compound heterozygous mutations in PSMB8, as found in this patient. PSMB8 is an immunoproteasome unit involved in proteolysis and maintenance of cell homeostasis, she explained.

Treatment of the syndrome involves high-dose corticosteroids (usually 1-2 mg/kg day), which helps improve cutaneous eruptions, joint pain, and fever, but it is important to remember that disease flares can occur with tapering, Dr. Hunt noted.

Response is typically poor in patients treated with steroid-sparing agents, such as methotrexate, cyclosporine, azathioprine, or IVIG, as well as with tumor necrosis factor–alpha inhibitors and interleukin-1 receptor antagonists.

“But there is an interesting molecule on the horizon for possibly treating this more specifically and that’s JAK inhibitors,” she said, noting that a National Institutes of Health compassionate use clinical research trial is evaluating the JAK 1/2 inhibitor, baricitinib.

Dr. Hunt reported having no relevant disclosures.

[email protected]

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BOSTON – Annular erythematous plaques in a child with fever and dense, atypical, mixed mononuclear and neutrophilic dermal infiltrate on biopsy could signal the recently described autoinflammatory disorder known as CANDLE Syndrome, according to Raegan Hunt, MD.

CANDLE, which stands for chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature, is a proteasome-associated autoinflammatory syndrome characterized by dysregulation of type 1 interferon signaling, Dr. Hunt of Baylor College of Medicine and Texas Children’s Hospital said during a presentation at the American Academy of Dermatology summer meeting.

Dr. Raegan Hunt

She described a case involving a 12-year-old girl with erythematous, warm, tender, nonpruritic papules and plaques on the superior chest, neck, and upper back. Most had an annular configuration with central clearing and occasionally central duskiness and ulceration.

The child also sometimes had violaceous swelling of the eyelid, nodules on the ear, and figurate erythematous plaques on the upper arm.

“She’s been having these since she was an infant in periodic bursts, and carried a diagnosis of annular erythema of infancy,” Dr. Hunt said.

Other symptoms included recurrent fevers, myalgias, transient and migratory arthritis, elevated C-reactive protein and erythrocyte sedimentation rate, and aseptic meningitis requiring hospitalization.

She had no family history of autoimmune disease, immune deficiency, or other genetic diseases, Dr. Hunt said.

Courtesy Dr. Raegan Hunt
These are typical lesions of CANDLE syndrome.

“She was treated with methotrexate and prednisone, as well as IVIG [intravenous immunoglobulin] every 4 weeks. Her prednisone was never weaned successfully below 0.8 mg/kg. She had complications of chronic corticosteroid disease, including many fractures,” she said.

A biopsy showed a dense infiltrate of atypical, mixed mononuclear and neutrophilic dermal infiltrate.

“These taken together are suggestive of ... CANDLE,” she said.

Genetic testing confirmed the presence of a compound heterozygous mutation in the proteasome subunit beta type 9, or PSMB8 gene.

Key features of CANDLE syndrome, first described in a 2010 article and further described by Liu, et al in 2012, include early disease onset, recurrent febrile episodes, skin lesions – including recurrent attacks of erythematous annular plaques and violaceous swelling of the eyelids, delayed physical development, progressive lipodystrophy, arthralgias, systemic inflammation, and aseptic meningitis episodes.

“Our patient did have very, very subtle lipodystrophy, but overall not as quick onset as some other [cases in children] that have been described,” Dr. Hunt said.

The type 1 interferonopathy is of autosomal recessive inheritance, and involves either homozygous or compound heterozygous mutations in PSMB8, as found in this patient. PSMB8 is an immunoproteasome unit involved in proteolysis and maintenance of cell homeostasis, she explained.

Treatment of the syndrome involves high-dose corticosteroids (usually 1-2 mg/kg day), which helps improve cutaneous eruptions, joint pain, and fever, but it is important to remember that disease flares can occur with tapering, Dr. Hunt noted.

Response is typically poor in patients treated with steroid-sparing agents, such as methotrexate, cyclosporine, azathioprine, or IVIG, as well as with tumor necrosis factor–alpha inhibitors and interleukin-1 receptor antagonists.

“But there is an interesting molecule on the horizon for possibly treating this more specifically and that’s JAK inhibitors,” she said, noting that a National Institutes of Health compassionate use clinical research trial is evaluating the JAK 1/2 inhibitor, baricitinib.

Dr. Hunt reported having no relevant disclosures.

[email protected]

BOSTON – Annular erythematous plaques in a child with fever and dense, atypical, mixed mononuclear and neutrophilic dermal infiltrate on biopsy could signal the recently described autoinflammatory disorder known as CANDLE Syndrome, according to Raegan Hunt, MD.

CANDLE, which stands for chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature, is a proteasome-associated autoinflammatory syndrome characterized by dysregulation of type 1 interferon signaling, Dr. Hunt of Baylor College of Medicine and Texas Children’s Hospital said during a presentation at the American Academy of Dermatology summer meeting.

Dr. Raegan Hunt

She described a case involving a 12-year-old girl with erythematous, warm, tender, nonpruritic papules and plaques on the superior chest, neck, and upper back. Most had an annular configuration with central clearing and occasionally central duskiness and ulceration.

The child also sometimes had violaceous swelling of the eyelid, nodules on the ear, and figurate erythematous plaques on the upper arm.

“She’s been having these since she was an infant in periodic bursts, and carried a diagnosis of annular erythema of infancy,” Dr. Hunt said.

Other symptoms included recurrent fevers, myalgias, transient and migratory arthritis, elevated C-reactive protein and erythrocyte sedimentation rate, and aseptic meningitis requiring hospitalization.

She had no family history of autoimmune disease, immune deficiency, or other genetic diseases, Dr. Hunt said.

Courtesy Dr. Raegan Hunt
These are typical lesions of CANDLE syndrome.

“She was treated with methotrexate and prednisone, as well as IVIG [intravenous immunoglobulin] every 4 weeks. Her prednisone was never weaned successfully below 0.8 mg/kg. She had complications of chronic corticosteroid disease, including many fractures,” she said.

A biopsy showed a dense infiltrate of atypical, mixed mononuclear and neutrophilic dermal infiltrate.

“These taken together are suggestive of ... CANDLE,” she said.

Genetic testing confirmed the presence of a compound heterozygous mutation in the proteasome subunit beta type 9, or PSMB8 gene.

Key features of CANDLE syndrome, first described in a 2010 article and further described by Liu, et al in 2012, include early disease onset, recurrent febrile episodes, skin lesions – including recurrent attacks of erythematous annular plaques and violaceous swelling of the eyelids, delayed physical development, progressive lipodystrophy, arthralgias, systemic inflammation, and aseptic meningitis episodes.

“Our patient did have very, very subtle lipodystrophy, but overall not as quick onset as some other [cases in children] that have been described,” Dr. Hunt said.

The type 1 interferonopathy is of autosomal recessive inheritance, and involves either homozygous or compound heterozygous mutations in PSMB8, as found in this patient. PSMB8 is an immunoproteasome unit involved in proteolysis and maintenance of cell homeostasis, she explained.

Treatment of the syndrome involves high-dose corticosteroids (usually 1-2 mg/kg day), which helps improve cutaneous eruptions, joint pain, and fever, but it is important to remember that disease flares can occur with tapering, Dr. Hunt noted.

Response is typically poor in patients treated with steroid-sparing agents, such as methotrexate, cyclosporine, azathioprine, or IVIG, as well as with tumor necrosis factor–alpha inhibitors and interleukin-1 receptor antagonists.

“But there is an interesting molecule on the horizon for possibly treating this more specifically and that’s JAK inhibitors,” she said, noting that a National Institutes of Health compassionate use clinical research trial is evaluating the JAK 1/2 inhibitor, baricitinib.

Dr. Hunt reported having no relevant disclosures.

[email protected]

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EXPERT ANALYSIS FROM THE AAD SUMMER ACADEMY 2016

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Key clinical point: Annular erythematous plaques in a child with fever and dense, atypical, mixed mononuclear and neutrophilic dermal infiltrate on biopsy could signal the recently described autoinflammatory disorder known as CANDLE syndrome.

Major finding: Genetic testing confirmed the presence of a compound heterozygous mutation in the proteasome subunit beta type 9, or PSMB8 gene.

Data source: Expert analysis – case description.

Disclosures: Dr. Hunt reported having no disclosures.

Flu vaccine prevented hospitalizations in patients 50 and older

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Flu vaccine prevented hospitalizations in patients 50 and older

The seasonal influenza vaccination reduced flu-related hospitalizations by 56.8% among people aged 50 and older during a recent flu season, according to a report published in Clinical Infectious Diseases.

Even in the oldest age group – the population with the highest risk of developing flu complications and perhaps the weakest immune response – influenza vaccination prevented serious complications, said Fiona P. Havers, MD, of the influenza division, Centers for Disease Control and Prevention, Atlanta, and her associates.

 

Dr. Fiona Havers

Data on vaccine efficacy in older adults are sparse, and randomized, placebo-controlled trials to gather evidence would be unethical. Dr. Havers and her colleagues studied the issue using a case-control design, focusing on community-dwelling adults aged 50 years and older during the 2010-2011 flu season. They identified 368 patients across 10 states who were hospitalized for polymerase chain reaction–confirmed influenza and matched them for age and county of residence with 773 control subjects.

Hospitalized case-patients were less likely to have been vaccinated (55%) than were control subjects (63%). Thus, the flu vaccine reduced the risk of hospitalization for influenza by 56.8% overall.

 

©Wavebreakmedia/Thinkstock

Vaccination reduced hospitalization for influenza by 63.9% in the youngest age group (50-64 years), by 61.0% in the intermediate age group (65-74 years), and by 57.3% in the oldest age group (75 years and older).

These results are similar to those reported in other studies assessing the same time period, including one that evaluated vaccine efficacy in ambulatory adults in the United States and Europe. They also are consistent with the results of observational studies performed during different flu seasons, the investigators said (Clin Infect Dis. 2016 Aug 2. doi: 10.1093/cid/ciw512).

Compared with control subjects, case-patients were more likely to be of nonwhite race, to be of Hispanic ethnicity, to have a lower income, to have had fewer years of education, to have two or more chronic health conditions, to have required recent hospitalization for respiratory problems, to have impaired mobility, and to have lower functional status.

“These findings support current U.S. recommendations for annual influenza vaccination in older adults, especially in adults aged 65 and older who are at higher risk of influenza-associated complications,” Dr. Havers and her associates said.

The Centers for Disease Control and Prevention supported the study. Dr. Havers reported having no relevant financial disclosures; one of her associates reported ties to Genentech, Merck, Novavax, and Pfizer.

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The seasonal influenza vaccination reduced flu-related hospitalizations by 56.8% among people aged 50 and older during a recent flu season, according to a report published in Clinical Infectious Diseases.

Even in the oldest age group – the population with the highest risk of developing flu complications and perhaps the weakest immune response – influenza vaccination prevented serious complications, said Fiona P. Havers, MD, of the influenza division, Centers for Disease Control and Prevention, Atlanta, and her associates.

 

Dr. Fiona Havers

Data on vaccine efficacy in older adults are sparse, and randomized, placebo-controlled trials to gather evidence would be unethical. Dr. Havers and her colleagues studied the issue using a case-control design, focusing on community-dwelling adults aged 50 years and older during the 2010-2011 flu season. They identified 368 patients across 10 states who were hospitalized for polymerase chain reaction–confirmed influenza and matched them for age and county of residence with 773 control subjects.

Hospitalized case-patients were less likely to have been vaccinated (55%) than were control subjects (63%). Thus, the flu vaccine reduced the risk of hospitalization for influenza by 56.8% overall.

 

©Wavebreakmedia/Thinkstock

Vaccination reduced hospitalization for influenza by 63.9% in the youngest age group (50-64 years), by 61.0% in the intermediate age group (65-74 years), and by 57.3% in the oldest age group (75 years and older).

These results are similar to those reported in other studies assessing the same time period, including one that evaluated vaccine efficacy in ambulatory adults in the United States and Europe. They also are consistent with the results of observational studies performed during different flu seasons, the investigators said (Clin Infect Dis. 2016 Aug 2. doi: 10.1093/cid/ciw512).

Compared with control subjects, case-patients were more likely to be of nonwhite race, to be of Hispanic ethnicity, to have a lower income, to have had fewer years of education, to have two or more chronic health conditions, to have required recent hospitalization for respiratory problems, to have impaired mobility, and to have lower functional status.

“These findings support current U.S. recommendations for annual influenza vaccination in older adults, especially in adults aged 65 and older who are at higher risk of influenza-associated complications,” Dr. Havers and her associates said.

The Centers for Disease Control and Prevention supported the study. Dr. Havers reported having no relevant financial disclosures; one of her associates reported ties to Genentech, Merck, Novavax, and Pfizer.

The seasonal influenza vaccination reduced flu-related hospitalizations by 56.8% among people aged 50 and older during a recent flu season, according to a report published in Clinical Infectious Diseases.

Even in the oldest age group – the population with the highest risk of developing flu complications and perhaps the weakest immune response – influenza vaccination prevented serious complications, said Fiona P. Havers, MD, of the influenza division, Centers for Disease Control and Prevention, Atlanta, and her associates.

 

Dr. Fiona Havers

Data on vaccine efficacy in older adults are sparse, and randomized, placebo-controlled trials to gather evidence would be unethical. Dr. Havers and her colleagues studied the issue using a case-control design, focusing on community-dwelling adults aged 50 years and older during the 2010-2011 flu season. They identified 368 patients across 10 states who were hospitalized for polymerase chain reaction–confirmed influenza and matched them for age and county of residence with 773 control subjects.

Hospitalized case-patients were less likely to have been vaccinated (55%) than were control subjects (63%). Thus, the flu vaccine reduced the risk of hospitalization for influenza by 56.8% overall.

 

©Wavebreakmedia/Thinkstock

Vaccination reduced hospitalization for influenza by 63.9% in the youngest age group (50-64 years), by 61.0% in the intermediate age group (65-74 years), and by 57.3% in the oldest age group (75 years and older).

These results are similar to those reported in other studies assessing the same time period, including one that evaluated vaccine efficacy in ambulatory adults in the United States and Europe. They also are consistent with the results of observational studies performed during different flu seasons, the investigators said (Clin Infect Dis. 2016 Aug 2. doi: 10.1093/cid/ciw512).

Compared with control subjects, case-patients were more likely to be of nonwhite race, to be of Hispanic ethnicity, to have a lower income, to have had fewer years of education, to have two or more chronic health conditions, to have required recent hospitalization for respiratory problems, to have impaired mobility, and to have lower functional status.

“These findings support current U.S. recommendations for annual influenza vaccination in older adults, especially in adults aged 65 and older who are at higher risk of influenza-associated complications,” Dr. Havers and her associates said.

The Centers for Disease Control and Prevention supported the study. Dr. Havers reported having no relevant financial disclosures; one of her associates reported ties to Genentech, Merck, Novavax, and Pfizer.

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FROM CLINICAL INFECTIOUS DISEASES

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Key clinical point: Seasonal influenza vaccination reduced flu-related hospitalizations by 56.8% in people aged 50 years and older.

Major finding: Vaccination reduced hospitalization for influenza by 63.9% in people aged 50-64 years, by 61.0% in those aged 65-74 years, and by 57.3% in those aged 75 years and older.

Data source: A retrospective case-control study involving 368 cases and 773 matched controls assessed during a single recent flu season.

Disclosures: The Centers for Disease Control and Prevention supported the study. Dr. Havers reported having no relevant financial disclosures; one of her associates reported ties to Genentech, Merck, Novavax, and Pfizer.

Extended-release granisetron superior antiemetic for cisplatin chemotherapy

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Extended-release granisetron superior antiemetic for cisplatin chemotherapy

SAN DIEGO – An investigational extended-release formulation of granisetron outperformed ondansetron as a component of triple-drug antiemetic therapy for patients on cisplatin-based highly emetogenic chemotherapy, Dr. Lee Schwartzberg reported at the annual meeting of the Society of Gynecologic Oncology.

He presented a post hoc subgroup analysis drawn from the previously reported pivotal phase III 942-patient MAGIC trial of extended-release granisetron (Sustol), formerly known as APF530, versus ondansetron (Zofran) as part of the triple-drug antiemetic regimen recommended in National Community Cancer Network guidelines for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients on highly emetogenic chemotherapy .

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Dr. Schwartzberg and coinvestigators focused on the 251 MAGIC participants on high-dose cisplatin-based chemotherapy. The reason? Few studies have examined the management of CINV in patients on platinum-based regimens, commonly used in treating gynecologic cancers, explained Dr. Schwartzberg, medical director of the West Clinic in Memphis.

Sustol consists of 2% granisetron in a proprietary slow-release vehicle. A single 500-mg subcutaneous dose containing 10 mg of granisetron maintains therapeutic blood levels of granisetron for 5 days or longer. These pharmacokinetics make APF530 an attractive strategy for preventing both acute and delayed chemotherapy-induced nausea and vomiting. The delayed phase, which affects many cancer patients 2-5 days following administration of chemotherapy, has traditionally been a particularly difficult management challenge.

National Community Cancer Network guidelines recommend that patients on highly emetogenic chemotherapy receive a potent three-drug antiemetic regimen consisting of a 5-hydroxytryptoamine-3 receptor antagonist – ondansetron and granisetron fall within this class – along with a neurokinin-1 receptor antagonist and dexamethasone.

MAGIC was a double-blind, prospective, multicenter trial in which 942 patients on highly emetogenic chemotherapy received either 500 mg of subcutaneous extended-release granisetron or intravenous ondansetron at 0.15 mg/kg. In addition, all participants concomitantly got 150 mg of the neurokinin-1 receptor antagonist fosaprepitant (Emend) plus 12 mg of IV dexamethasone on day 1, followed by 8 mg of oral dexamethasone once on day 2 and 8 mg twice daily on days 3 and 4.

In the overall trial, extended-release granisetron significantly outperformed ondansetron. The primary endpoint – complete response defined as no emesis and no use of rescue medication for CINV during the delayed phase – was achieved in 64.7% of the Sustol group, compared with 56.6% on ondansetron.

Results in Dr. Schwartzberg’s post hoc analysis confined to the 251 randomized patients on high-dose cisplatin-based chemotherapy paralleled those in the overall trial: a 64.8% complete response rate in the delayed phase in the granisetron group versus 56.3% with ondansetron. That absolute 8.5% difference favoring the investigational agent translates to a number needed to treat (NNT) of 12.

In the 112 women on highly emetogenic cisplatin-based chemotherapy, the complete response rates in the delayed phase were 61.6% with extended-release granisetron and 53.2% with ondansetron, for an absolute 10.3% difference and an NNT of 10.

Heron Therapeutics, which is developing extended-release granisetron, is awaiting word from the Food and Drug Administration regarding the company’s application for marketing approval.

The MAGIC trial was sponsored by Heron Therapeutics. Dr. Schwartzberg is a consultant to the company.

[email protected]

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SAN DIEGO – An investigational extended-release formulation of granisetron outperformed ondansetron as a component of triple-drug antiemetic therapy for patients on cisplatin-based highly emetogenic chemotherapy, Dr. Lee Schwartzberg reported at the annual meeting of the Society of Gynecologic Oncology.

He presented a post hoc subgroup analysis drawn from the previously reported pivotal phase III 942-patient MAGIC trial of extended-release granisetron (Sustol), formerly known as APF530, versus ondansetron (Zofran) as part of the triple-drug antiemetic regimen recommended in National Community Cancer Network guidelines for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients on highly emetogenic chemotherapy .

©BluePlanetEarth/thinkstockphotos.com

Dr. Schwartzberg and coinvestigators focused on the 251 MAGIC participants on high-dose cisplatin-based chemotherapy. The reason? Few studies have examined the management of CINV in patients on platinum-based regimens, commonly used in treating gynecologic cancers, explained Dr. Schwartzberg, medical director of the West Clinic in Memphis.

Sustol consists of 2% granisetron in a proprietary slow-release vehicle. A single 500-mg subcutaneous dose containing 10 mg of granisetron maintains therapeutic blood levels of granisetron for 5 days or longer. These pharmacokinetics make APF530 an attractive strategy for preventing both acute and delayed chemotherapy-induced nausea and vomiting. The delayed phase, which affects many cancer patients 2-5 days following administration of chemotherapy, has traditionally been a particularly difficult management challenge.

National Community Cancer Network guidelines recommend that patients on highly emetogenic chemotherapy receive a potent three-drug antiemetic regimen consisting of a 5-hydroxytryptoamine-3 receptor antagonist – ondansetron and granisetron fall within this class – along with a neurokinin-1 receptor antagonist and dexamethasone.

MAGIC was a double-blind, prospective, multicenter trial in which 942 patients on highly emetogenic chemotherapy received either 500 mg of subcutaneous extended-release granisetron or intravenous ondansetron at 0.15 mg/kg. In addition, all participants concomitantly got 150 mg of the neurokinin-1 receptor antagonist fosaprepitant (Emend) plus 12 mg of IV dexamethasone on day 1, followed by 8 mg of oral dexamethasone once on day 2 and 8 mg twice daily on days 3 and 4.

In the overall trial, extended-release granisetron significantly outperformed ondansetron. The primary endpoint – complete response defined as no emesis and no use of rescue medication for CINV during the delayed phase – was achieved in 64.7% of the Sustol group, compared with 56.6% on ondansetron.

Results in Dr. Schwartzberg’s post hoc analysis confined to the 251 randomized patients on high-dose cisplatin-based chemotherapy paralleled those in the overall trial: a 64.8% complete response rate in the delayed phase in the granisetron group versus 56.3% with ondansetron. That absolute 8.5% difference favoring the investigational agent translates to a number needed to treat (NNT) of 12.

In the 112 women on highly emetogenic cisplatin-based chemotherapy, the complete response rates in the delayed phase were 61.6% with extended-release granisetron and 53.2% with ondansetron, for an absolute 10.3% difference and an NNT of 10.

Heron Therapeutics, which is developing extended-release granisetron, is awaiting word from the Food and Drug Administration regarding the company’s application for marketing approval.

The MAGIC trial was sponsored by Heron Therapeutics. Dr. Schwartzberg is a consultant to the company.

[email protected]

SAN DIEGO – An investigational extended-release formulation of granisetron outperformed ondansetron as a component of triple-drug antiemetic therapy for patients on cisplatin-based highly emetogenic chemotherapy, Dr. Lee Schwartzberg reported at the annual meeting of the Society of Gynecologic Oncology.

He presented a post hoc subgroup analysis drawn from the previously reported pivotal phase III 942-patient MAGIC trial of extended-release granisetron (Sustol), formerly known as APF530, versus ondansetron (Zofran) as part of the triple-drug antiemetic regimen recommended in National Community Cancer Network guidelines for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients on highly emetogenic chemotherapy .

©BluePlanetEarth/thinkstockphotos.com

Dr. Schwartzberg and coinvestigators focused on the 251 MAGIC participants on high-dose cisplatin-based chemotherapy. The reason? Few studies have examined the management of CINV in patients on platinum-based regimens, commonly used in treating gynecologic cancers, explained Dr. Schwartzberg, medical director of the West Clinic in Memphis.

Sustol consists of 2% granisetron in a proprietary slow-release vehicle. A single 500-mg subcutaneous dose containing 10 mg of granisetron maintains therapeutic blood levels of granisetron for 5 days or longer. These pharmacokinetics make APF530 an attractive strategy for preventing both acute and delayed chemotherapy-induced nausea and vomiting. The delayed phase, which affects many cancer patients 2-5 days following administration of chemotherapy, has traditionally been a particularly difficult management challenge.

National Community Cancer Network guidelines recommend that patients on highly emetogenic chemotherapy receive a potent three-drug antiemetic regimen consisting of a 5-hydroxytryptoamine-3 receptor antagonist – ondansetron and granisetron fall within this class – along with a neurokinin-1 receptor antagonist and dexamethasone.

MAGIC was a double-blind, prospective, multicenter trial in which 942 patients on highly emetogenic chemotherapy received either 500 mg of subcutaneous extended-release granisetron or intravenous ondansetron at 0.15 mg/kg. In addition, all participants concomitantly got 150 mg of the neurokinin-1 receptor antagonist fosaprepitant (Emend) plus 12 mg of IV dexamethasone on day 1, followed by 8 mg of oral dexamethasone once on day 2 and 8 mg twice daily on days 3 and 4.

In the overall trial, extended-release granisetron significantly outperformed ondansetron. The primary endpoint – complete response defined as no emesis and no use of rescue medication for CINV during the delayed phase – was achieved in 64.7% of the Sustol group, compared with 56.6% on ondansetron.

Results in Dr. Schwartzberg’s post hoc analysis confined to the 251 randomized patients on high-dose cisplatin-based chemotherapy paralleled those in the overall trial: a 64.8% complete response rate in the delayed phase in the granisetron group versus 56.3% with ondansetron. That absolute 8.5% difference favoring the investigational agent translates to a number needed to treat (NNT) of 12.

In the 112 women on highly emetogenic cisplatin-based chemotherapy, the complete response rates in the delayed phase were 61.6% with extended-release granisetron and 53.2% with ondansetron, for an absolute 10.3% difference and an NNT of 10.

Heron Therapeutics, which is developing extended-release granisetron, is awaiting word from the Food and Drug Administration regarding the company’s application for marketing approval.

The MAGIC trial was sponsored by Heron Therapeutics. Dr. Schwartzberg is a consultant to the company.

[email protected]

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Key clinical point: Investigational agent outperforms ondansetron during delayed phase of highly emetogenic cisplatin-based chemotherapy-induced nausea and vomiting.

Major finding: Complete response rate during delayed phase was 64.8% when triple antiemetic therapy included extended-release granisetron and 56.3% when the regimen included ondansetron.

Data source: This post hoc subgroup analysis of the 942-patient pivotal phase III MAGIC trial focused specifically on the 251 participants on highly emetogenic cisplatin-based chemotherapy.

Disclosures: The study presenter reported serving as a consultant to Heron Therapeutics, which sponsored the MAGIC trial.

VIDEO: Varenicline underused for smoking cessation

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ROME – “Unfounded” concerns about cardiovascular effects have contributed to underuse of varenicline for smoking cessation, Kornelia Kotseva, MD, said at the annual congress of the European Society of Cardiology.

In an exclusive video interview, Dr. Kotseva of Imperial College, London, told our reporter Bruce Jancin that meta-analyses have shown no significant difference in serious cardiovascular events between varenicline-treated patients and those on placebo, regardless of whether the patients had underlying cardiovascular disease.

Varenicline use for smoking cessation reduces the risk of cardiovascular events by 36%, she reported, more than reductions seen with either nicotine replacement therapy or bupropion.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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ROME – “Unfounded” concerns about cardiovascular effects have contributed to underuse of varenicline for smoking cessation, Kornelia Kotseva, MD, said at the annual congress of the European Society of Cardiology.

In an exclusive video interview, Dr. Kotseva of Imperial College, London, told our reporter Bruce Jancin that meta-analyses have shown no significant difference in serious cardiovascular events between varenicline-treated patients and those on placebo, regardless of whether the patients had underlying cardiovascular disease.

Varenicline use for smoking cessation reduces the risk of cardiovascular events by 36%, she reported, more than reductions seen with either nicotine replacement therapy or bupropion.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

ROME – “Unfounded” concerns about cardiovascular effects have contributed to underuse of varenicline for smoking cessation, Kornelia Kotseva, MD, said at the annual congress of the European Society of Cardiology.

In an exclusive video interview, Dr. Kotseva of Imperial College, London, told our reporter Bruce Jancin that meta-analyses have shown no significant difference in serious cardiovascular events between varenicline-treated patients and those on placebo, regardless of whether the patients had underlying cardiovascular disease.

Varenicline use for smoking cessation reduces the risk of cardiovascular events by 36%, she reported, more than reductions seen with either nicotine replacement therapy or bupropion.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

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sSHM’s 2016 State of Hospital Medicine Report (SoHM) is now available, and it’s unquestionably the best source of detail regarding how hospital medicine groups are configured and operated.1

The SoHM is published in even years and combines data from two sources:

  • Hospitalist data from Medical Group Management Association’s Physician Compensation and Productivity Survey. Within the SoHM, you will find the same figures for hospitalist compensation, production, and a few related metrics that are from the MGMA survey report.
  • SHM’s survey of hospital medicine groups. This survey drills into significant detail on things like scope of clinical practice, staffing levels, work schedules, bonus metrics, CPT code distribution, roles for NPs and PAs, and the amount of financial support provided to the group.

There are several new topics in this year’s SoHM, including CME allowances, utilization of prolonged service codes, and charge capture methodologies being used by hospital medicine groups. My colleague, Leslie Flores, has been very involved in the survey for 10 years and has written a blog with more details.

One Caveat …

The mix of survey respondents varies and includes a much larger portion of hospital medicine groups employed by multi-state management companies than prior surveys. Even if a parameter hasn’t changed for any hospitalist group, the fact that responses come from different contingents of the hospitalist workforce can result in a different result from one survey to the next. It is difficult to be certain if variations across successive surveys reflect a real change in the marketplace or are a function of variation in the respondent population.

Now let’s review and analyze some of this year’s survey findings for hospital medicine groups caring for adults:

Financial Support Stayed Flat

The amount of financial support provided to a hospital medicine group per FTE has increased significantly in every prior survey. This money typically comes from the hospital that the hospital medicine group serves and is sometimes referred to as the “subsidy.” For hospital medicine groups serving adults, it was $139,000 in 2012 and $156,000 in 2014.

The current survey showed a median of $157,500, essentially unchanged from two years prior. This is either an aberration in the survey (e.g., a result of a different survey population) or an indicator that this amount has begun to level off. Clearly, there is an upper limit to the amount of financial support the marketplace can support, but from my experience working with hospitalist groups around the country, I haven’t seen evidence that we’ve reached that point. I suspect it is an aberration and future surveys will show a continued rising trend, though perhaps not as rapidly as in years past.

Compensation Method Is Evolving

A mean of 14.7% of compensation was tied to production, up from around 10% in prior surveys. And the portion tied to performance (e.g., patient satisfaction, quality metrics) was unchanged at 6%. It’s interesting that despite proliferation of pay-for-performance programs and increasing emphasis on quality and value, it is the productivity portion of compensation that increased. It’s hard to know if that is a meaningful trend.

Compensation Amount Continues to Increase

For hospitalists caring for adults, the median amount of compensation rose to $278,746, up from $253,000 in 2014, $234,000 in 2013, and $221,000 in 2011. These figures come from the MGMA survey, and the financial support figures above come from the separate SHM survey. That means it’s impossible to make firm conclusions about how the numbers do or don’t interrelate.

Don’t forget that surveys report all forms of compensation, including base, production, bonus, extra shifts, and other elements. This year’s $278,746 includes all the bonus dollars earned by each hospitalist in the survey. We can make a very rough guess at the bonus by multiplying the portion of total compensation tied to performance in the SHM survey (6%) by the total compensation ($278,746) from the MGMA survey, which comes to $13,397. But we still don’t know the portion of the total bonus dollars available that represents. My experience is that the total bonus dollars available is around $20,000 or more at most hospital medicine groups. Therefore, a doctor who earned $13,397 presumably didn’t meet all performance goals.

 

 

A Deeper Dive into Hospital Medicine Group Finances

It is really interesting to ponder where the dollars come from to fund higher hospitalist compensation if the financial support provided per FTE hasn’t increased. Perhaps hospitalists are generating more encounters, work relative value units (wRVUs), or professional fee collections?

Median professional fee collections were $213,000 this year, up from $151,000 in the prior survey two years ago. This increase could, in theory, fully fund the higher hospitalist compensation without the need for an increase in other sources of revenue.

So why are collections up? It could be because hospitalists are coding the average visit at a higher level: 2.02 wRVUs per encounter this year compared to 1.97 in 2014 and 1.91 in 2012. The survey can’t help distinguish whether this increase is because we’re seeing more complex patients or whether we’re improving our documentation to catch up with the complexity of the patients we’ve been seeing all along. I suspect it is both.

The increase in wRVUs per encounter, however, is offset by a continued downward trend in numbers of encounters: 1,684 this year compared to 1,850 in 2014 and 2,078 in 2012. The total wRVUs generated per hospitalist in a year stayed about the same at 4,247 compared to 4,298 in 2014.

The best explanation for why total collections are up would be that payor rates have increased. But Medicare, which accounts for about 60%–65% of the payor mix for most hospital medicine groups, hasn’t increased rates enough to explain this, and I’m not aware of other payor classes that have increased significantly. Another explanation could be that hospital medicine groups are simply doing a better job with billing and collections and other revenue-cycle management activities, resulting in increased revenue.

I guess it shouldn’t be surprising that some of the survey results don’t seem internally consistent. The data come from two different surveys, the response rate for each question varies, and other issues mean the survey just can’t provide that level of precision. We also need to keep in mind that analyses like I’ve provided here are only very rough explanations. But I think they’re still valuable to think about even if they don’t provide definitive answers. TH

Reference

  1. 2016 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed August 9, 2016.


Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

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sSHM’s 2016 State of Hospital Medicine Report (SoHM) is now available, and it’s unquestionably the best source of detail regarding how hospital medicine groups are configured and operated.1

The SoHM is published in even years and combines data from two sources:

  • Hospitalist data from Medical Group Management Association’s Physician Compensation and Productivity Survey. Within the SoHM, you will find the same figures for hospitalist compensation, production, and a few related metrics that are from the MGMA survey report.
  • SHM’s survey of hospital medicine groups. This survey drills into significant detail on things like scope of clinical practice, staffing levels, work schedules, bonus metrics, CPT code distribution, roles for NPs and PAs, and the amount of financial support provided to the group.

There are several new topics in this year’s SoHM, including CME allowances, utilization of prolonged service codes, and charge capture methodologies being used by hospital medicine groups. My colleague, Leslie Flores, has been very involved in the survey for 10 years and has written a blog with more details.

One Caveat …

The mix of survey respondents varies and includes a much larger portion of hospital medicine groups employed by multi-state management companies than prior surveys. Even if a parameter hasn’t changed for any hospitalist group, the fact that responses come from different contingents of the hospitalist workforce can result in a different result from one survey to the next. It is difficult to be certain if variations across successive surveys reflect a real change in the marketplace or are a function of variation in the respondent population.

Now let’s review and analyze some of this year’s survey findings for hospital medicine groups caring for adults:

Financial Support Stayed Flat

The amount of financial support provided to a hospital medicine group per FTE has increased significantly in every prior survey. This money typically comes from the hospital that the hospital medicine group serves and is sometimes referred to as the “subsidy.” For hospital medicine groups serving adults, it was $139,000 in 2012 and $156,000 in 2014.

The current survey showed a median of $157,500, essentially unchanged from two years prior. This is either an aberration in the survey (e.g., a result of a different survey population) or an indicator that this amount has begun to level off. Clearly, there is an upper limit to the amount of financial support the marketplace can support, but from my experience working with hospitalist groups around the country, I haven’t seen evidence that we’ve reached that point. I suspect it is an aberration and future surveys will show a continued rising trend, though perhaps not as rapidly as in years past.

Compensation Method Is Evolving

A mean of 14.7% of compensation was tied to production, up from around 10% in prior surveys. And the portion tied to performance (e.g., patient satisfaction, quality metrics) was unchanged at 6%. It’s interesting that despite proliferation of pay-for-performance programs and increasing emphasis on quality and value, it is the productivity portion of compensation that increased. It’s hard to know if that is a meaningful trend.

Compensation Amount Continues to Increase

For hospitalists caring for adults, the median amount of compensation rose to $278,746, up from $253,000 in 2014, $234,000 in 2013, and $221,000 in 2011. These figures come from the MGMA survey, and the financial support figures above come from the separate SHM survey. That means it’s impossible to make firm conclusions about how the numbers do or don’t interrelate.

Don’t forget that surveys report all forms of compensation, including base, production, bonus, extra shifts, and other elements. This year’s $278,746 includes all the bonus dollars earned by each hospitalist in the survey. We can make a very rough guess at the bonus by multiplying the portion of total compensation tied to performance in the SHM survey (6%) by the total compensation ($278,746) from the MGMA survey, which comes to $13,397. But we still don’t know the portion of the total bonus dollars available that represents. My experience is that the total bonus dollars available is around $20,000 or more at most hospital medicine groups. Therefore, a doctor who earned $13,397 presumably didn’t meet all performance goals.

 

 

A Deeper Dive into Hospital Medicine Group Finances

It is really interesting to ponder where the dollars come from to fund higher hospitalist compensation if the financial support provided per FTE hasn’t increased. Perhaps hospitalists are generating more encounters, work relative value units (wRVUs), or professional fee collections?

Median professional fee collections were $213,000 this year, up from $151,000 in the prior survey two years ago. This increase could, in theory, fully fund the higher hospitalist compensation without the need for an increase in other sources of revenue.

So why are collections up? It could be because hospitalists are coding the average visit at a higher level: 2.02 wRVUs per encounter this year compared to 1.97 in 2014 and 1.91 in 2012. The survey can’t help distinguish whether this increase is because we’re seeing more complex patients or whether we’re improving our documentation to catch up with the complexity of the patients we’ve been seeing all along. I suspect it is both.

The increase in wRVUs per encounter, however, is offset by a continued downward trend in numbers of encounters: 1,684 this year compared to 1,850 in 2014 and 2,078 in 2012. The total wRVUs generated per hospitalist in a year stayed about the same at 4,247 compared to 4,298 in 2014.

The best explanation for why total collections are up would be that payor rates have increased. But Medicare, which accounts for about 60%–65% of the payor mix for most hospital medicine groups, hasn’t increased rates enough to explain this, and I’m not aware of other payor classes that have increased significantly. Another explanation could be that hospital medicine groups are simply doing a better job with billing and collections and other revenue-cycle management activities, resulting in increased revenue.

I guess it shouldn’t be surprising that some of the survey results don’t seem internally consistent. The data come from two different surveys, the response rate for each question varies, and other issues mean the survey just can’t provide that level of precision. We also need to keep in mind that analyses like I’ve provided here are only very rough explanations. But I think they’re still valuable to think about even if they don’t provide definitive answers. TH

Reference

  1. 2016 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed August 9, 2016.


Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

sSHM’s 2016 State of Hospital Medicine Report (SoHM) is now available, and it’s unquestionably the best source of detail regarding how hospital medicine groups are configured and operated.1

The SoHM is published in even years and combines data from two sources:

  • Hospitalist data from Medical Group Management Association’s Physician Compensation and Productivity Survey. Within the SoHM, you will find the same figures for hospitalist compensation, production, and a few related metrics that are from the MGMA survey report.
  • SHM’s survey of hospital medicine groups. This survey drills into significant detail on things like scope of clinical practice, staffing levels, work schedules, bonus metrics, CPT code distribution, roles for NPs and PAs, and the amount of financial support provided to the group.

There are several new topics in this year’s SoHM, including CME allowances, utilization of prolonged service codes, and charge capture methodologies being used by hospital medicine groups. My colleague, Leslie Flores, has been very involved in the survey for 10 years and has written a blog with more details.

One Caveat …

The mix of survey respondents varies and includes a much larger portion of hospital medicine groups employed by multi-state management companies than prior surveys. Even if a parameter hasn’t changed for any hospitalist group, the fact that responses come from different contingents of the hospitalist workforce can result in a different result from one survey to the next. It is difficult to be certain if variations across successive surveys reflect a real change in the marketplace or are a function of variation in the respondent population.

Now let’s review and analyze some of this year’s survey findings for hospital medicine groups caring for adults:

Financial Support Stayed Flat

The amount of financial support provided to a hospital medicine group per FTE has increased significantly in every prior survey. This money typically comes from the hospital that the hospital medicine group serves and is sometimes referred to as the “subsidy.” For hospital medicine groups serving adults, it was $139,000 in 2012 and $156,000 in 2014.

The current survey showed a median of $157,500, essentially unchanged from two years prior. This is either an aberration in the survey (e.g., a result of a different survey population) or an indicator that this amount has begun to level off. Clearly, there is an upper limit to the amount of financial support the marketplace can support, but from my experience working with hospitalist groups around the country, I haven’t seen evidence that we’ve reached that point. I suspect it is an aberration and future surveys will show a continued rising trend, though perhaps not as rapidly as in years past.

Compensation Method Is Evolving

A mean of 14.7% of compensation was tied to production, up from around 10% in prior surveys. And the portion tied to performance (e.g., patient satisfaction, quality metrics) was unchanged at 6%. It’s interesting that despite proliferation of pay-for-performance programs and increasing emphasis on quality and value, it is the productivity portion of compensation that increased. It’s hard to know if that is a meaningful trend.

Compensation Amount Continues to Increase

For hospitalists caring for adults, the median amount of compensation rose to $278,746, up from $253,000 in 2014, $234,000 in 2013, and $221,000 in 2011. These figures come from the MGMA survey, and the financial support figures above come from the separate SHM survey. That means it’s impossible to make firm conclusions about how the numbers do or don’t interrelate.

Don’t forget that surveys report all forms of compensation, including base, production, bonus, extra shifts, and other elements. This year’s $278,746 includes all the bonus dollars earned by each hospitalist in the survey. We can make a very rough guess at the bonus by multiplying the portion of total compensation tied to performance in the SHM survey (6%) by the total compensation ($278,746) from the MGMA survey, which comes to $13,397. But we still don’t know the portion of the total bonus dollars available that represents. My experience is that the total bonus dollars available is around $20,000 or more at most hospital medicine groups. Therefore, a doctor who earned $13,397 presumably didn’t meet all performance goals.

 

 

A Deeper Dive into Hospital Medicine Group Finances

It is really interesting to ponder where the dollars come from to fund higher hospitalist compensation if the financial support provided per FTE hasn’t increased. Perhaps hospitalists are generating more encounters, work relative value units (wRVUs), or professional fee collections?

Median professional fee collections were $213,000 this year, up from $151,000 in the prior survey two years ago. This increase could, in theory, fully fund the higher hospitalist compensation without the need for an increase in other sources of revenue.

So why are collections up? It could be because hospitalists are coding the average visit at a higher level: 2.02 wRVUs per encounter this year compared to 1.97 in 2014 and 1.91 in 2012. The survey can’t help distinguish whether this increase is because we’re seeing more complex patients or whether we’re improving our documentation to catch up with the complexity of the patients we’ve been seeing all along. I suspect it is both.

The increase in wRVUs per encounter, however, is offset by a continued downward trend in numbers of encounters: 1,684 this year compared to 1,850 in 2014 and 2,078 in 2012. The total wRVUs generated per hospitalist in a year stayed about the same at 4,247 compared to 4,298 in 2014.

The best explanation for why total collections are up would be that payor rates have increased. But Medicare, which accounts for about 60%–65% of the payor mix for most hospital medicine groups, hasn’t increased rates enough to explain this, and I’m not aware of other payor classes that have increased significantly. Another explanation could be that hospital medicine groups are simply doing a better job with billing and collections and other revenue-cycle management activities, resulting in increased revenue.

I guess it shouldn’t be surprising that some of the survey results don’t seem internally consistent. The data come from two different surveys, the response rate for each question varies, and other issues mean the survey just can’t provide that level of precision. We also need to keep in mind that analyses like I’ve provided here are only very rough explanations. But I think they’re still valuable to think about even if they don’t provide definitive answers. TH

Reference

  1. 2016 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed August 9, 2016.


Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

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FDA advises testing all donated blood for Zika virus

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Blood donation in progress

The US Food and Drug Administration (FDA) has issued a revised guidance intended to reduce the risk of Zika virus transmission via blood.

The guidance recommends that all states and US territories screen donated whole blood and blood components for the Zika virus with a test authorized under an investigational new drug application or a licensed test when available.

For plasma and certain platelet products, an FDA-approved pathogen-reduction device can be used instead of a screening test.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

In February, the FDA issued a guidance recommending that areas with active Zika virus transmission screen donated whole blood and blood components for the Zika virus, use pathogen-reduction devices, or halt blood collection and obtain blood from areas of the US without active virus transmission.

The FDA decided to update its guidance after considering the available scientific evidence, consulting with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, MD, the FDA’s acting chief scientist.

“We are issuing revised guidance for immediate implementation in order to help maintain the safety of the US blood supply.”

Testing of donated blood is already underway in Florida, Puerto Rico, and other areas, and it has proven effective in identifying donations infected with Zika virus.

The FDA said nationwide testing will be in effect until the risk of Zika virus transmission via transfusion is reduced.

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Blood donation in progress

The US Food and Drug Administration (FDA) has issued a revised guidance intended to reduce the risk of Zika virus transmission via blood.

The guidance recommends that all states and US territories screen donated whole blood and blood components for the Zika virus with a test authorized under an investigational new drug application or a licensed test when available.

For plasma and certain platelet products, an FDA-approved pathogen-reduction device can be used instead of a screening test.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

In February, the FDA issued a guidance recommending that areas with active Zika virus transmission screen donated whole blood and blood components for the Zika virus, use pathogen-reduction devices, or halt blood collection and obtain blood from areas of the US without active virus transmission.

The FDA decided to update its guidance after considering the available scientific evidence, consulting with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, MD, the FDA’s acting chief scientist.

“We are issuing revised guidance for immediate implementation in order to help maintain the safety of the US blood supply.”

Testing of donated blood is already underway in Florida, Puerto Rico, and other areas, and it has proven effective in identifying donations infected with Zika virus.

The FDA said nationwide testing will be in effect until the risk of Zika virus transmission via transfusion is reduced.

Blood donation in progress

The US Food and Drug Administration (FDA) has issued a revised guidance intended to reduce the risk of Zika virus transmission via blood.

The guidance recommends that all states and US territories screen donated whole blood and blood components for the Zika virus with a test authorized under an investigational new drug application or a licensed test when available.

For plasma and certain platelet products, an FDA-approved pathogen-reduction device can be used instead of a screening test.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

In February, the FDA issued a guidance recommending that areas with active Zika virus transmission screen donated whole blood and blood components for the Zika virus, use pathogen-reduction devices, or halt blood collection and obtain blood from areas of the US without active virus transmission.

The FDA decided to update its guidance after considering the available scientific evidence, consulting with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, MD, the FDA’s acting chief scientist.

“We are issuing revised guidance for immediate implementation in order to help maintain the safety of the US blood supply.”

Testing of donated blood is already underway in Florida, Puerto Rico, and other areas, and it has proven effective in identifying donations infected with Zika virus.

The FDA said nationwide testing will be in effect until the risk of Zika virus transmission via transfusion is reduced.

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Hyperammonemia May Signal the Presence of Generalized Convulsive Seizures

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Blood ammonia levels were correlated with generalized convulsive seizures.

Elevated blood ammonia levels may help differentiate epileptic generalized convulsive seizures (GCS) from other events, suggests a recent report in Epilepsia. When Rawan Albadareen and associates measured blood ammonia levels in 78 patients with GCS, psychogenic nonepileptic seizures with convulsions (PNES-C), or focal seizures using video–electroencephalography (vEEG) monitoring, they discovered that ammonia levels at or above 80 μmol/L could classify generalized convulsive seizures in 80% of patients with a sensitivity of 53.9% and specificity of 100%. Their findings suggest that transient hyperammonemia may serve as an inexpensive test for the diagnosis of GCS.

 

Albadareen R, Gronseth G, Landazuri P, et al. Postictal ammonia as a biomarker for electrographic convulsive seizures: a prospective study. Epilepsia. 2016;57(8): 1221-1227.

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Blood ammonia levels were correlated with generalized convulsive seizures.
Blood ammonia levels were correlated with generalized convulsive seizures.

Elevated blood ammonia levels may help differentiate epileptic generalized convulsive seizures (GCS) from other events, suggests a recent report in Epilepsia. When Rawan Albadareen and associates measured blood ammonia levels in 78 patients with GCS, psychogenic nonepileptic seizures with convulsions (PNES-C), or focal seizures using video–electroencephalography (vEEG) monitoring, they discovered that ammonia levels at or above 80 μmol/L could classify generalized convulsive seizures in 80% of patients with a sensitivity of 53.9% and specificity of 100%. Their findings suggest that transient hyperammonemia may serve as an inexpensive test for the diagnosis of GCS.

 

Albadareen R, Gronseth G, Landazuri P, et al. Postictal ammonia as a biomarker for electrographic convulsive seizures: a prospective study. Epilepsia. 2016;57(8): 1221-1227.

Elevated blood ammonia levels may help differentiate epileptic generalized convulsive seizures (GCS) from other events, suggests a recent report in Epilepsia. When Rawan Albadareen and associates measured blood ammonia levels in 78 patients with GCS, psychogenic nonepileptic seizures with convulsions (PNES-C), or focal seizures using video–electroencephalography (vEEG) monitoring, they discovered that ammonia levels at or above 80 μmol/L could classify generalized convulsive seizures in 80% of patients with a sensitivity of 53.9% and specificity of 100%. Their findings suggest that transient hyperammonemia may serve as an inexpensive test for the diagnosis of GCS.

 

Albadareen R, Gronseth G, Landazuri P, et al. Postictal ammonia as a biomarker for electrographic convulsive seizures: a prospective study. Epilepsia. 2016;57(8): 1221-1227.

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Finding a Link Between Ictal Fear and Auras

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Patients with ictal fears were more likely to experience temporal lobe auras, accompanied by cephalic, olfactory, and visceral symptoms.

In order to determine if there is an association between ictal fear and other auras and with patients’ gender and age, investigators analyzed 536 participants in the Epilepsy Phenome/Genome Project.  Among 36 patients with confirmed ictal fear, the phenomenon was associated with temporal lobe auras, including cephalic, olfactory, and visceral symptoms, as well as déjà vu and derealization. Aphasias were also correlated with ictal fear but researchers found no link between such fear and age or gender.

Chong DJ, Dugan P; The EPGP Investigators. Ictal fear: associations with age, gender, and other experiential phenomena. Epilepsy Behav. 2016;62:153-158. 

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Patients with ictal fears were more likely to experience temporal lobe auras, accompanied by cephalic, olfactory, and visceral symptoms.
Patients with ictal fears were more likely to experience temporal lobe auras, accompanied by cephalic, olfactory, and visceral symptoms.

In order to determine if there is an association between ictal fear and other auras and with patients’ gender and age, investigators analyzed 536 participants in the Epilepsy Phenome/Genome Project.  Among 36 patients with confirmed ictal fear, the phenomenon was associated with temporal lobe auras, including cephalic, olfactory, and visceral symptoms, as well as déjà vu and derealization. Aphasias were also correlated with ictal fear but researchers found no link between such fear and age or gender.

Chong DJ, Dugan P; The EPGP Investigators. Ictal fear: associations with age, gender, and other experiential phenomena. Epilepsy Behav. 2016;62:153-158. 

In order to determine if there is an association between ictal fear and other auras and with patients’ gender and age, investigators analyzed 536 participants in the Epilepsy Phenome/Genome Project.  Among 36 patients with confirmed ictal fear, the phenomenon was associated with temporal lobe auras, including cephalic, olfactory, and visceral symptoms, as well as déjà vu and derealization. Aphasias were also correlated with ictal fear but researchers found no link between such fear and age or gender.

Chong DJ, Dugan P; The EPGP Investigators. Ictal fear: associations with age, gender, and other experiential phenomena. Epilepsy Behav. 2016;62:153-158. 

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JZP-110 May Have Low Potential for Abuse

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DENVER—The abuse potential of the investigational drug JZP-110 may be similar to or lower than that of the Schedule IV stimulant phentermine, according to data presented at the 30th Anniversary Meeting of the Associated Professional Sleep Societies. Results also indicate that the 300-mg therapeutic dose of JZP-110 is well tolerated and entails no new safety concerns.

JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor and wake-promoting agent under evaluation for the treatment of narcolepsy and obstructive sleep apnea. The use of some therapies for narcolepsy is limited by their abuse potential. Lawrence P. Carter, PhD, Senior Director in Clinical Development at Jazz Pharmaceuticals and Assistant Professor of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences in Little Rock, and colleagues sought to evaluate the abuse potential of JZP-110, compared with phentermine as a positive control in a human abuse liability study.

Eligible participants were healthy individuals between ages 18 and 55, had a self-reported history of recreational polydrug use, and had used a stimulant recreationally 10 or more times in the previous five years and once or more in the previous three months. Participants who tolerated phentermine in a qualification phase and who preferred it to placebo were enrolled in the test phase. In the test phase, participants were randomized to one of six double-blind treatment sequences that included single administration of placebo; 300-mg, 600-mg, and 1,200-mg doses of JZP-110; and 45-mg and 90-mg doses of phentermine. The primary end point was peak rating of Liking at the Moment during the first 12 hours on the Visual Analog Scale (VAS). Secondary end points included retrospective VAS ratings at 24 hours after administration for Overall Drug Liking, and how much the participant would like to take the drug again.

In all, 43 participants (mean age, 29.3) were enrolled, 74.4% of whom were African American. Thirty-seven participants completed the study, and two discontinued the study because of adverse events. Liking at the Moment was generally greater after taking phentermine than after taking JZP-110. For all doses of JZP-110, peak Liking at the Moment was significantly greater than for placebo and significantly less than for 90 mg of phentermine. Retrospective evaluation of Overall Drug Liking for JZP-110 at 600 mg and 1,200 mg was not significantly different from placebo and was significantly less than both doses of phentermine. At all doses of JZP-110, participants were significantly less willing to take the drug again, compared with both doses of phentermine.

Erik Greb

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DENVER—The abuse potential of the investigational drug JZP-110 may be similar to or lower than that of the Schedule IV stimulant phentermine, according to data presented at the 30th Anniversary Meeting of the Associated Professional Sleep Societies. Results also indicate that the 300-mg therapeutic dose of JZP-110 is well tolerated and entails no new safety concerns.

JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor and wake-promoting agent under evaluation for the treatment of narcolepsy and obstructive sleep apnea. The use of some therapies for narcolepsy is limited by their abuse potential. Lawrence P. Carter, PhD, Senior Director in Clinical Development at Jazz Pharmaceuticals and Assistant Professor of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences in Little Rock, and colleagues sought to evaluate the abuse potential of JZP-110, compared with phentermine as a positive control in a human abuse liability study.

Eligible participants were healthy individuals between ages 18 and 55, had a self-reported history of recreational polydrug use, and had used a stimulant recreationally 10 or more times in the previous five years and once or more in the previous three months. Participants who tolerated phentermine in a qualification phase and who preferred it to placebo were enrolled in the test phase. In the test phase, participants were randomized to one of six double-blind treatment sequences that included single administration of placebo; 300-mg, 600-mg, and 1,200-mg doses of JZP-110; and 45-mg and 90-mg doses of phentermine. The primary end point was peak rating of Liking at the Moment during the first 12 hours on the Visual Analog Scale (VAS). Secondary end points included retrospective VAS ratings at 24 hours after administration for Overall Drug Liking, and how much the participant would like to take the drug again.

In all, 43 participants (mean age, 29.3) were enrolled, 74.4% of whom were African American. Thirty-seven participants completed the study, and two discontinued the study because of adverse events. Liking at the Moment was generally greater after taking phentermine than after taking JZP-110. For all doses of JZP-110, peak Liking at the Moment was significantly greater than for placebo and significantly less than for 90 mg of phentermine. Retrospective evaluation of Overall Drug Liking for JZP-110 at 600 mg and 1,200 mg was not significantly different from placebo and was significantly less than both doses of phentermine. At all doses of JZP-110, participants were significantly less willing to take the drug again, compared with both doses of phentermine.

Erik Greb

DENVER—The abuse potential of the investigational drug JZP-110 may be similar to or lower than that of the Schedule IV stimulant phentermine, according to data presented at the 30th Anniversary Meeting of the Associated Professional Sleep Societies. Results also indicate that the 300-mg therapeutic dose of JZP-110 is well tolerated and entails no new safety concerns.

JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor and wake-promoting agent under evaluation for the treatment of narcolepsy and obstructive sleep apnea. The use of some therapies for narcolepsy is limited by their abuse potential. Lawrence P. Carter, PhD, Senior Director in Clinical Development at Jazz Pharmaceuticals and Assistant Professor of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences in Little Rock, and colleagues sought to evaluate the abuse potential of JZP-110, compared with phentermine as a positive control in a human abuse liability study.

Eligible participants were healthy individuals between ages 18 and 55, had a self-reported history of recreational polydrug use, and had used a stimulant recreationally 10 or more times in the previous five years and once or more in the previous three months. Participants who tolerated phentermine in a qualification phase and who preferred it to placebo were enrolled in the test phase. In the test phase, participants were randomized to one of six double-blind treatment sequences that included single administration of placebo; 300-mg, 600-mg, and 1,200-mg doses of JZP-110; and 45-mg and 90-mg doses of phentermine. The primary end point was peak rating of Liking at the Moment during the first 12 hours on the Visual Analog Scale (VAS). Secondary end points included retrospective VAS ratings at 24 hours after administration for Overall Drug Liking, and how much the participant would like to take the drug again.

In all, 43 participants (mean age, 29.3) were enrolled, 74.4% of whom were African American. Thirty-seven participants completed the study, and two discontinued the study because of adverse events. Liking at the Moment was generally greater after taking phentermine than after taking JZP-110. For all doses of JZP-110, peak Liking at the Moment was significantly greater than for placebo and significantly less than for 90 mg of phentermine. Retrospective evaluation of Overall Drug Liking for JZP-110 at 600 mg and 1,200 mg was not significantly different from placebo and was significantly less than both doses of phentermine. At all doses of JZP-110, participants were significantly less willing to take the drug again, compared with both doses of phentermine.

Erik Greb

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