As many as 1 in 5 asthma-related deaths in the US is due to occupational exposure—and many could be prevented, according to CDC researchers.

The researchers analyzed reports from 1999-2016 of asthma-related mortality and occupations of the people involved. Of 3,396 deaths (3,396 in 2015 alone), between 11% and 21% were due to occupational exposures. Health care workers and construction workers were at highest risk.

By industry, the highest number of deaths were among men working in construction (13%) and women in health care (14%). By occupation, the most deaths were among men construction trades workers (11%) and women office and administrative support workers (9%).

The researchers note that ongoing exposure to cleaners, disinfectants, and antibiotics, all can trigger asthma. But they also point out that steps can be successfully taken to limit the type of exposure that exacerbates asthma symptoms, such as replacing powdered latex gloves with powder-free natural rubber latex or nonlatex gloves.

In an interview with MD Magazine, principle investigator Jacek Mazurek, MD, PhD, said there’s also an opportunity for health care providers to intervene more effectively. “Inadequate screening of workers for occupational exposures by health providers and lack of recognition of associations between workplace exposures and asthma symptoms remain the main reasons for underrecognition and underdiagnosis of work-related asthma.”

The Occupational Safety and Health Administration offers guidance for diagnosing work-related asthma at https://www.osha.gov/SLTC/occupationalasthma/.

As many as 1 in 5 asthma-related deaths in the US is due to occupational exposure—and many could be prevented, according to CDC researchers.

The researchers analyzed reports from 1999-2016 of asthma-related mortality and occupations of the people involved. Of 3,396 deaths (3,396 in 2015 alone), between 11% and 21% were due to occupational exposures. Health care workers and construction workers were at highest risk.

By industry, the highest number of deaths were among men working in construction (13%) and women in health care (14%). By occupation, the most deaths were among men construction trades workers (11%) and women office and administrative support workers (9%).

The researchers note that ongoing exposure to cleaners, disinfectants, and antibiotics, all can trigger asthma. But they also point out that steps can be successfully taken to limit the type of exposure that exacerbates asthma symptoms, such as replacing powdered latex gloves with powder-free natural rubber latex or nonlatex gloves.

In an interview with MD Magazine, principle investigator Jacek Mazurek, MD, PhD, said there’s also an opportunity for health care providers to intervene more effectively. “Inadequate screening of workers for occupational exposures by health providers and lack of recognition of associations between workplace exposures and asthma symptoms remain the main reasons for underrecognition and underdiagnosis of work-related asthma.”

The Occupational Safety and Health Administration offers guidance for diagnosing work-related asthma at https://www.osha.gov/SLTC/occupationalasthma/.

As many as 1 in 5 asthma-related deaths in the US is due to occupational exposure—and many could be prevented, according to CDC researchers.

The researchers analyzed reports from 1999-2016 of asthma-related mortality and occupations of the people involved. Of 3,396 deaths (3,396 in 2015 alone), between 11% and 21% were due to occupational exposures. Health care workers and construction workers were at highest risk.

By industry, the highest number of deaths were among men working in construction (13%) and women in health care (14%). By occupation, the most deaths were among men construction trades workers (11%) and women office and administrative support workers (9%).

The researchers note that ongoing exposure to cleaners, disinfectants, and antibiotics, all can trigger asthma. But they also point out that steps can be successfully taken to limit the type of exposure that exacerbates asthma symptoms, such as replacing powdered latex gloves with powder-free natural rubber latex or nonlatex gloves.

In an interview with MD Magazine, principle investigator Jacek Mazurek, MD, PhD, said there’s also an opportunity for health care providers to intervene more effectively. “Inadequate screening of workers for occupational exposures by health providers and lack of recognition of associations between workplace exposures and asthma symptoms remain the main reasons for underrecognition and underdiagnosis of work-related asthma.”

The Occupational Safety and Health Administration offers guidance for diagnosing work-related asthma at https://www.osha.gov/SLTC/occupationalasthma/.

Bristol Myers Squibb

ORLANDO—Interim trial results suggest andexanet alfa can reverse the activity of factor Xa inhibitors in patients with acute major bleeding.

Andexanet alfa reduced median anti-factor Xa inhibitor activity by 91% in patients taking apixaban, 88% in those taking rivaroxaban, and 75% in patients taking enoxaparin.

Eleven percent of patients experienced thrombotic events, and 12% of patients died.

Stuart J. Connolly, MD, of McMaster University in Hamilton, Ontario, Canada, presented these results at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18, abstract 409-14).

The trial, known as ANNEXA-4, was sponsored by Portola Pharmaceuticals, Inc.

“These data are particularly compelling when you consider the high-risk profile of the ANNEXA-4 population, which includes a substantial number of elderly patients presenting with intracranial hemorrhage and anticoagulated for venous thromboembolism, and the lack of any FDA- or EMA-approved reversal agent for these patients,” Dr Connolly said.

“The interim efficacy and safety data continue to support the promising role of AndexXa [the brand name for andexanet alfa] as an antidote to reverse anticoagulation in factor Xa-associated bleeding.”

Andexanet alfa is a recombinant modified factor Xa molecule designed to bind to and disable factor Xa inhibitors, thereby allowing factor Xa produced by the body to play its normal role in the formation of blood clots.

In earlier trials of healthy volunteers, andexanet alfa reversed the anticoagulant effect of factor Xa inhibitors without any significant safety problems.

ANNEXA-4 is an ongoing trial of andexanet alfa in patients experiencing major bleeding while taking factor Xa inhibitors.

Dr Connolly presented safety outcomes for 227 trial subjects and adjudicated efficacy outcomes for 132 subjects. All subjects presented with acute major bleeding within 18 hours of taking a factor Xa inhibitor, including apixaban, rivaroxaban, enoxaparin, and edoxaban.

The patients received andexanet alfa given as a bolus dose over 20 to 30 minutes, followed by a 2-hour (120 minute) infusion. The dosage was determined based on the specific factor Xa inhibitor the patients were taking and how long it had been since their last dose.

The patients were evaluated for 30 days after andexanet alfa administration.

Efficacy

The median age of the efficacy population (n=137) was 77, and 51% (n=70) were male. Indications for anticoagulation included atrial fibrillation (Afib, 76%, n=104), venous thromboembolism (VTE, 28%, n=38), and both Afib and VTE (4%, n=6).

Patients were receiving apixaban (n=68), rivaroxaban (n=54), or enoxaparin (n=10). None of these patients had received edoxaban.

Types of bleeding included intracranial hemorrhage (ICH, 57%, n=78), gastrointestinal (GI) bleeding (31%, n=43), and “other” bleeding (12%, n=16).

The researchers assessed andexanet alfa’s efficacy in terms of 2 co-primary endpoints—reduction in anti-factor Xa inhibitor activity and achievement of clinical hemostasis by 12 hours after administration. Hemostatic efficacy was assessed by an independent endpoint adjudication committee as “excellent,” “good,” or “poor/none.”

After the bolus dose of andexanet alfa, the median anti-factor Xa inhibitor activity was reduced by 91% for patients taking apixaban, 88% for those taking rivaroxaban, and 75% for those taking enoxaparin.

For patients taking rivaroxaban, the median anti-factor Xa inhibitor activity was reduced by 88% at the end of the bolus dose, 87% at the end of the infusion, 42% at 4 hours, 49% at 8 hours, and 60% at 12 hours.

For patients taking apixaban, the median anti-factor Xa inhibitor activity was reduced by 91% at the end of the bolus dose, 91% at the end of the infusion, 36% at 4 hours, 30% at 8 hours, and 35% at 12 hours.

Overall, 83% of patients had “excellent” or “good” clinical hemostasis, and 17% had “poor/none.”

Hemostasis was deemed excellent or good in 83% of patients on rivaroxaban, 82% of those on apixaban, and 80% of those on enoxaparin. It was excellent/good in 86% of patients with GI bleeding, 81% of patients with ICH, and 80% of patients with bleeding at other sites.

Safety

The median age of the safety population (n=227) was 77, and 52% (n=117) were male. Indications for anticoagulation included Afib (78%, n=178), VTE (23%, n=52), and both Afib and VTE (4%, n=8).

Patients were receiving apixaban (n=117), rivaroxaban (n=90), enoxaparin (n=17), and edoxaban (n=3). Types of bleeding included ICH (61%, n=139), GI (27%, n=62), and “other” (12%, n=26).

During the 30-day follow-up period, the rate of thrombotic events was 11% (n=24) for the entire population and 12% (n=17) among patients with ICH.

The mortality rate for all patients was 12% (n=27). Eleven deaths were due to cardiovascular causes.

According to Dr Connolly, these rates of adverse events are in line with what would be expected given the underlying medical condition of the patients in the trial and the fact that many (43%) had not resumed anticoagulant treatment in the 30-day follow-up period.

Two patients experienced an infusion reaction.

None of the patients developed antibodies to factor Xa or factor X, and there were no neutralizing antibodies to andexanet alfa.

Bristol Myers Squibb

ORLANDO—Interim trial results suggest andexanet alfa can reverse the activity of factor Xa inhibitors in patients with acute major bleeding.

Andexanet alfa reduced median anti-factor Xa inhibitor activity by 91% in patients taking apixaban, 88% in those taking rivaroxaban, and 75% in patients taking enoxaparin.

Eleven percent of patients experienced thrombotic events, and 12% of patients died.

Stuart J. Connolly, MD, of McMaster University in Hamilton, Ontario, Canada, presented these results at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18, abstract 409-14).

The trial, known as ANNEXA-4, was sponsored by Portola Pharmaceuticals, Inc.

“These data are particularly compelling when you consider the high-risk profile of the ANNEXA-4 population, which includes a substantial number of elderly patients presenting with intracranial hemorrhage and anticoagulated for venous thromboembolism, and the lack of any FDA- or EMA-approved reversal agent for these patients,” Dr Connolly said.

“The interim efficacy and safety data continue to support the promising role of AndexXa [the brand name for andexanet alfa] as an antidote to reverse anticoagulation in factor Xa-associated bleeding.”

Andexanet alfa is a recombinant modified factor Xa molecule designed to bind to and disable factor Xa inhibitors, thereby allowing factor Xa produced by the body to play its normal role in the formation of blood clots.

In earlier trials of healthy volunteers, andexanet alfa reversed the anticoagulant effect of factor Xa inhibitors without any significant safety problems.

ANNEXA-4 is an ongoing trial of andexanet alfa in patients experiencing major bleeding while taking factor Xa inhibitors.

Dr Connolly presented safety outcomes for 227 trial subjects and adjudicated efficacy outcomes for 132 subjects. All subjects presented with acute major bleeding within 18 hours of taking a factor Xa inhibitor, including apixaban, rivaroxaban, enoxaparin, and edoxaban.

The patients received andexanet alfa given as a bolus dose over 20 to 30 minutes, followed by a 2-hour (120 minute) infusion. The dosage was determined based on the specific factor Xa inhibitor the patients were taking and how long it had been since their last dose.

The patients were evaluated for 30 days after andexanet alfa administration.

Efficacy

The median age of the efficacy population (n=137) was 77, and 51% (n=70) were male. Indications for anticoagulation included atrial fibrillation (Afib, 76%, n=104), venous thromboembolism (VTE, 28%, n=38), and both Afib and VTE (4%, n=6).

Patients were receiving apixaban (n=68), rivaroxaban (n=54), or enoxaparin (n=10). None of these patients had received edoxaban.

Types of bleeding included intracranial hemorrhage (ICH, 57%, n=78), gastrointestinal (GI) bleeding (31%, n=43), and “other” bleeding (12%, n=16).

The researchers assessed andexanet alfa’s efficacy in terms of 2 co-primary endpoints—reduction in anti-factor Xa inhibitor activity and achievement of clinical hemostasis by 12 hours after administration. Hemostatic efficacy was assessed by an independent endpoint adjudication committee as “excellent,” “good,” or “poor/none.”

After the bolus dose of andexanet alfa, the median anti-factor Xa inhibitor activity was reduced by 91% for patients taking apixaban, 88% for those taking rivaroxaban, and 75% for those taking enoxaparin.

For patients taking rivaroxaban, the median anti-factor Xa inhibitor activity was reduced by 88% at the end of the bolus dose, 87% at the end of the infusion, 42% at 4 hours, 49% at 8 hours, and 60% at 12 hours.

For patients taking apixaban, the median anti-factor Xa inhibitor activity was reduced by 91% at the end of the bolus dose, 91% at the end of the infusion, 36% at 4 hours, 30% at 8 hours, and 35% at 12 hours.

Overall, 83% of patients had “excellent” or “good” clinical hemostasis, and 17% had “poor/none.”

Hemostasis was deemed excellent or good in 83% of patients on rivaroxaban, 82% of those on apixaban, and 80% of those on enoxaparin. It was excellent/good in 86% of patients with GI bleeding, 81% of patients with ICH, and 80% of patients with bleeding at other sites.

Safety

The median age of the safety population (n=227) was 77, and 52% (n=117) were male. Indications for anticoagulation included Afib (78%, n=178), VTE (23%, n=52), and both Afib and VTE (4%, n=8).

Patients were receiving apixaban (n=117), rivaroxaban (n=90), enoxaparin (n=17), and edoxaban (n=3). Types of bleeding included ICH (61%, n=139), GI (27%, n=62), and “other” (12%, n=26).

During the 30-day follow-up period, the rate of thrombotic events was 11% (n=24) for the entire population and 12% (n=17) among patients with ICH.

The mortality rate for all patients was 12% (n=27). Eleven deaths were due to cardiovascular causes.

According to Dr Connolly, these rates of adverse events are in line with what would be expected given the underlying medical condition of the patients in the trial and the fact that many (43%) had not resumed anticoagulant treatment in the 30-day follow-up period.

Two patients experienced an infusion reaction.

None of the patients developed antibodies to factor Xa or factor X, and there were no neutralizing antibodies to andexanet alfa.

Bristol Myers Squibb

ORLANDO—Interim trial results suggest andexanet alfa can reverse the activity of factor Xa inhibitors in patients with acute major bleeding.

Andexanet alfa reduced median anti-factor Xa inhibitor activity by 91% in patients taking apixaban, 88% in those taking rivaroxaban, and 75% in patients taking enoxaparin.

Eleven percent of patients experienced thrombotic events, and 12% of patients died.

Stuart J. Connolly, MD, of McMaster University in Hamilton, Ontario, Canada, presented these results at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18, abstract 409-14).

The trial, known as ANNEXA-4, was sponsored by Portola Pharmaceuticals, Inc.

“These data are particularly compelling when you consider the high-risk profile of the ANNEXA-4 population, which includes a substantial number of elderly patients presenting with intracranial hemorrhage and anticoagulated for venous thromboembolism, and the lack of any FDA- or EMA-approved reversal agent for these patients,” Dr Connolly said.

“The interim efficacy and safety data continue to support the promising role of AndexXa [the brand name for andexanet alfa] as an antidote to reverse anticoagulation in factor Xa-associated bleeding.”

Andexanet alfa is a recombinant modified factor Xa molecule designed to bind to and disable factor Xa inhibitors, thereby allowing factor Xa produced by the body to play its normal role in the formation of blood clots.

In earlier trials of healthy volunteers, andexanet alfa reversed the anticoagulant effect of factor Xa inhibitors without any significant safety problems.

ANNEXA-4 is an ongoing trial of andexanet alfa in patients experiencing major bleeding while taking factor Xa inhibitors.

Dr Connolly presented safety outcomes for 227 trial subjects and adjudicated efficacy outcomes for 132 subjects. All subjects presented with acute major bleeding within 18 hours of taking a factor Xa inhibitor, including apixaban, rivaroxaban, enoxaparin, and edoxaban.

The patients received andexanet alfa given as a bolus dose over 20 to 30 minutes, followed by a 2-hour (120 minute) infusion. The dosage was determined based on the specific factor Xa inhibitor the patients were taking and how long it had been since their last dose.

The patients were evaluated for 30 days after andexanet alfa administration.

Efficacy

The median age of the efficacy population (n=137) was 77, and 51% (n=70) were male. Indications for anticoagulation included atrial fibrillation (Afib, 76%, n=104), venous thromboembolism (VTE, 28%, n=38), and both Afib and VTE (4%, n=6).

Patients were receiving apixaban (n=68), rivaroxaban (n=54), or enoxaparin (n=10). None of these patients had received edoxaban.

Types of bleeding included intracranial hemorrhage (ICH, 57%, n=78), gastrointestinal (GI) bleeding (31%, n=43), and “other” bleeding (12%, n=16).

The researchers assessed andexanet alfa’s efficacy in terms of 2 co-primary endpoints—reduction in anti-factor Xa inhibitor activity and achievement of clinical hemostasis by 12 hours after administration. Hemostatic efficacy was assessed by an independent endpoint adjudication committee as “excellent,” “good,” or “poor/none.”

After the bolus dose of andexanet alfa, the median anti-factor Xa inhibitor activity was reduced by 91% for patients taking apixaban, 88% for those taking rivaroxaban, and 75% for those taking enoxaparin.

For patients taking rivaroxaban, the median anti-factor Xa inhibitor activity was reduced by 88% at the end of the bolus dose, 87% at the end of the infusion, 42% at 4 hours, 49% at 8 hours, and 60% at 12 hours.

For patients taking apixaban, the median anti-factor Xa inhibitor activity was reduced by 91% at the end of the bolus dose, 91% at the end of the infusion, 36% at 4 hours, 30% at 8 hours, and 35% at 12 hours.

Overall, 83% of patients had “excellent” or “good” clinical hemostasis, and 17% had “poor/none.”

Hemostasis was deemed excellent or good in 83% of patients on rivaroxaban, 82% of those on apixaban, and 80% of those on enoxaparin. It was excellent/good in 86% of patients with GI bleeding, 81% of patients with ICH, and 80% of patients with bleeding at other sites.

Safety

The median age of the safety population (n=227) was 77, and 52% (n=117) were male. Indications for anticoagulation included Afib (78%, n=178), VTE (23%, n=52), and both Afib and VTE (4%, n=8).

Patients were receiving apixaban (n=117), rivaroxaban (n=90), enoxaparin (n=17), and edoxaban (n=3). Types of bleeding included ICH (61%, n=139), GI (27%, n=62), and “other” (12%, n=26).

During the 30-day follow-up period, the rate of thrombotic events was 11% (n=24) for the entire population and 12% (n=17) among patients with ICH.

The mortality rate for all patients was 12% (n=27). Eleven deaths were due to cardiovascular causes.

According to Dr Connolly, these rates of adverse events are in line with what would be expected given the underlying medical condition of the patients in the trial and the fact that many (43%) had not resumed anticoagulant treatment in the 30-day follow-up period.

Two patients experienced an infusion reaction.

None of the patients developed antibodies to factor Xa or factor X, and there were no neutralizing antibodies to andexanet alfa.

of Alabama at Birmingham

Free heme plays a key role in the adverse effects associated with massive transfusion of stored red blood cells (RBCs), according to researchers.

Experiments in a mouse model of trauma hemorrhage revealed a greater risk of mortality from bacterial pneumonia in mice that received transfusions of blood stored for 14 days, rather than fresh blood.

This greater risk was dependent upon free heme, which is released from RBCs during storage and upon transfusion.

In a study of human trauma patients, researchers found the amount of heme was proportional to the amount of blood transfused.

Brant M. Wagener, MD, PhD, of University of Alabama at Birmingham, and his colleagues detailed these findings in PLOS Medicine.

In the mouse model of trauma hemorrhage, the researchers resuscitated mice using either fresh blood (stored for 0 days) or blood stored for 2 weeks. (A 2-week storage of mouse blood approximates storage of human RBCs for 42 days.)

Two days after transfusion, the mice were challenged by instilling the lungs with the bacteria Pseudomonas aeruginosa.

Mice that received the stored blood had a significant increase in bacterial lung injury, as shown by higher mortality, and increased fluid accumulation and bacterial numbers in the lungs.

The researchers identified the connection between free heme and infection susceptibility/severity in 2 ways.

First, Pseudomonas aeruginosa-induced mortality was completely prevented by the addition of hemopexin, a scavenging protein that removes free heme from the blood.

Second, adding an inhibitor of toll-like receptor 4 (TLR4), or genetically removing TLR4 from mice, also prevented bacteria-induced mortality. Free heme—which is known to induce inflammatory injury to major organs in diseases like sickle cell or sepsis—acts, in part, by activating TLR4.

The researchers also found that transfusion with stored blood induced release of the inflammation mediator high mobility group box 1 (HMGB1). But an anti-HMGB1 antibody protected mice from bacteria-induced mortality.

The anti-HMGB1 antibody also restored macrophage-dependent phagocytosis of Pseudomonas aeruginosa in vitro.

Tissue culture experiments had revealed that free heme inhibits macrophages from ingesting Pseudomonas aeruginosa, and the addition of free heme increases permeability in endothelial cells.

Finally, in a 16-month study, the researchers found that human trauma-hemorrhage patients who received large amounts of transfused blood were also receiving amounts of free heme sufficient to overwhelm the normal amounts of hemopexin found in a person’s blood.

The researchers said this work underscores the need to confirm whether the storage age of transfused RBCs correlates with increasing levels of free heme after transfusion. The team would also like to establish whether patients with low ratios of hemopexin to free heme have a greater risk for adverse outcomes after massive transfusions.

of Alabama at Birmingham

Free heme plays a key role in the adverse effects associated with massive transfusion of stored red blood cells (RBCs), according to researchers.

Experiments in a mouse model of trauma hemorrhage revealed a greater risk of mortality from bacterial pneumonia in mice that received transfusions of blood stored for 14 days, rather than fresh blood.

This greater risk was dependent upon free heme, which is released from RBCs during storage and upon transfusion.

In a study of human trauma patients, researchers found the amount of heme was proportional to the amount of blood transfused.

Brant M. Wagener, MD, PhD, of University of Alabama at Birmingham, and his colleagues detailed these findings in PLOS Medicine.

In the mouse model of trauma hemorrhage, the researchers resuscitated mice using either fresh blood (stored for 0 days) or blood stored for 2 weeks. (A 2-week storage of mouse blood approximates storage of human RBCs for 42 days.)

Two days after transfusion, the mice were challenged by instilling the lungs with the bacteria Pseudomonas aeruginosa.

Mice that received the stored blood had a significant increase in bacterial lung injury, as shown by higher mortality, and increased fluid accumulation and bacterial numbers in the lungs.

The researchers identified the connection between free heme and infection susceptibility/severity in 2 ways.

First, Pseudomonas aeruginosa-induced mortality was completely prevented by the addition of hemopexin, a scavenging protein that removes free heme from the blood.

Second, adding an inhibitor of toll-like receptor 4 (TLR4), or genetically removing TLR4 from mice, also prevented bacteria-induced mortality. Free heme—which is known to induce inflammatory injury to major organs in diseases like sickle cell or sepsis—acts, in part, by activating TLR4.

The researchers also found that transfusion with stored blood induced release of the inflammation mediator high mobility group box 1 (HMGB1). But an anti-HMGB1 antibody protected mice from bacteria-induced mortality.

The anti-HMGB1 antibody also restored macrophage-dependent phagocytosis of Pseudomonas aeruginosa in vitro.

Tissue culture experiments had revealed that free heme inhibits macrophages from ingesting Pseudomonas aeruginosa, and the addition of free heme increases permeability in endothelial cells.

Finally, in a 16-month study, the researchers found that human trauma-hemorrhage patients who received large amounts of transfused blood were also receiving amounts of free heme sufficient to overwhelm the normal amounts of hemopexin found in a person’s blood.

The researchers said this work underscores the need to confirm whether the storage age of transfused RBCs correlates with increasing levels of free heme after transfusion. The team would also like to establish whether patients with low ratios of hemopexin to free heme have a greater risk for adverse outcomes after massive transfusions.

of Alabama at Birmingham

Free heme plays a key role in the adverse effects associated with massive transfusion of stored red blood cells (RBCs), according to researchers.

Experiments in a mouse model of trauma hemorrhage revealed a greater risk of mortality from bacterial pneumonia in mice that received transfusions of blood stored for 14 days, rather than fresh blood.

This greater risk was dependent upon free heme, which is released from RBCs during storage and upon transfusion.

In a study of human trauma patients, researchers found the amount of heme was proportional to the amount of blood transfused.

Brant M. Wagener, MD, PhD, of University of Alabama at Birmingham, and his colleagues detailed these findings in PLOS Medicine.

In the mouse model of trauma hemorrhage, the researchers resuscitated mice using either fresh blood (stored for 0 days) or blood stored for 2 weeks. (A 2-week storage of mouse blood approximates storage of human RBCs for 42 days.)

Two days after transfusion, the mice were challenged by instilling the lungs with the bacteria Pseudomonas aeruginosa.

Mice that received the stored blood had a significant increase in bacterial lung injury, as shown by higher mortality, and increased fluid accumulation and bacterial numbers in the lungs.

The researchers identified the connection between free heme and infection susceptibility/severity in 2 ways.

First, Pseudomonas aeruginosa-induced mortality was completely prevented by the addition of hemopexin, a scavenging protein that removes free heme from the blood.

Second, adding an inhibitor of toll-like receptor 4 (TLR4), or genetically removing TLR4 from mice, also prevented bacteria-induced mortality. Free heme—which is known to induce inflammatory injury to major organs in diseases like sickle cell or sepsis—acts, in part, by activating TLR4.

The researchers also found that transfusion with stored blood induced release of the inflammation mediator high mobility group box 1 (HMGB1). But an anti-HMGB1 antibody protected mice from bacteria-induced mortality.

The anti-HMGB1 antibody also restored macrophage-dependent phagocytosis of Pseudomonas aeruginosa in vitro.

Tissue culture experiments had revealed that free heme inhibits macrophages from ingesting Pseudomonas aeruginosa, and the addition of free heme increases permeability in endothelial cells.

Finally, in a 16-month study, the researchers found that human trauma-hemorrhage patients who received large amounts of transfused blood were also receiving amounts of free heme sufficient to overwhelm the normal amounts of hemopexin found in a person’s blood.

The researchers said this work underscores the need to confirm whether the storage age of transfused RBCs correlates with increasing levels of free heme after transfusion. The team would also like to establish whether patients with low ratios of hemopexin to free heme have a greater risk for adverse outcomes after massive transfusions.

Photo courtesy of CDC

ORLANDO—Results of a retrospective study showed that survivors of lymphoma or breast cancer had a significantly greater risk of congestive heart failure (CHF) than patients who did not have cancer.

This increased risk was observed as early as a year after cancer diagnosis but was still present 20 years after diagnosis.

Overall, 1 in 10 cancer patients had CHF at the 20-year mark.

“The majority of patients do not develop heart failure, but our research helps us recognize the factors associated with it and the importance of appropriate heart care following cancer treatment,” said Carolyn Larsen, MD, of the Mayo Clinic in Rochester, Minnesota.

“Our research suggests that periodic cardiac imaging to monitor for heart damage may be needed for some cancer patients, even if they have no signs of heart damage initially after chemotherapy. Additionally, it emphasizes that working to live a heart-healthy lifestyle is important for cancer patients and survivors to reduce the overall risk of heart disease.”

Dr Larsen and her colleagues presented this research as a poster (abstract 1105-066) at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18).

Patients

Using data from the Rochester Epidemiology Project, the researchers retrospectively tracked CHF cases in 900 cancer patients and 1550 non-cancer patients. Patients were treated in Olmsted County in Minnesota from 1985 to 2010.

For both patient groups, the median age at baseline was about 53, a little more than 90% of each group was white, and nearly 80% of each group was female.

Six to 7% of patients had diabetes, and about 30% of each group had hypertension. Thirty-eight percent of each group had hyperlipidemia, and 31% were obese.

Five percent of cancer patients and 2% of controls had coronary artery disease (P<0.001). This was the only significant difference in baseline characteristics.

Cancer patients had been diagnosed with non-Hodgkin lymphoma (28%), Hodgkin lymphoma (9%), or breast cancer (64%). Forty-seven percent had received radiation, including right chest (21%), left chest (23%), and mediastinal (4%).

Eighty-four percent of patients had received anthracycline therapy. The median doxorubicin isotoxic dose was 240 mg/m².

At baseline, 12% of cancer patients were on beta-blockers, 8% were on angiotensin converting enzyme inhibitors, 4% were on angiotensin receptor blockers, and 11% were on statins.

Results

Cancer patients were more than 3 times as likely as controls to develop CHF. The hazard ratio (HR) was 3.6 (P<0.01) in an analysis adjusted for age, gender, diabetes, hypertension, coronary artery disease, dyslipidemia, and obesity at baseline.

The increased CHF risk among cancer patients was evident after the first year from cancer diagnosis and persisted at 20 years of follow-up.

“The risk of heart failure doesn’t go away after a couple of years,” Dr Larsen said. “It’s a long-term issue that patients need to discuss with their doctors and use as motivation to stay heart healthy.”

The incidence of CHF—in cancer patients and controls, respectively—was as follows:

• 1 year—1.5% vs 0.1%
• 5 years—3.1% vs 0.9%
• 10 years—5.0% vs 2%
• 20 years—10.1% vs 5.8%.

A multivariable analysis in the cancer patients revealed a few independent risk factors for CHF, including:

• Doxorubicin isotoxic dose ≥ 300 mg/m² (HR=2.34, P=0.003)
• Age at diagnosis (HR=3.06 for age ≥ 80 vs 60-69, P=0.01)
• Coronary artery disease at diagnosis (HR=2.27, P=0.04)
• Diabetes mellitus at diagnosis (HR=2.39, P<0.01).

Dr Larsen said additional research is needed to determine why diabetes carries a greater risk than other traditional risk factors, such as high blood pressure, in this group.

Mitigating risk

These findings raise important questions about what the appropriate surveillance should be for heart problems post-cancer treatment, Dr Larsen said. She believes more frequent cardiac imaging may be warranted in some patients to detect signs of CHF earlier.

“It’s an area that needs to be better defined,” Dr Larsen said. “An echocardiogram is usually done 6 to 12 months after cancer treatment with an anthracycline, but how often should it be done after that? We need to be more vigilant in making sure we try to prevent or control heart issues post-cancer care, especially in light of the growing appreciation of the connection between some cancer treatments and heart disease.”

Dr Larsen also noted that patients themselves can play a role in decreasing their risk of CHF, even if they are starting at a disadvantage.

A heart-healthy lifestyle—maintaining a normal body weight, regular exercise, and controlling other risk factors such as high blood pressure, diabetes, and high cholesterol—can help lower the risk of heart disease and CHF.

“If patients know they have received a drug treatment that might increase their risk of heart failure, it’s even more important to take care of the aspects of their life that they can control to reduce their risk as much as possible and to work with their medical care team to detect issues as early as possible,” Dr Larsen said.

Photo courtesy of CDC

ORLANDO—Results of a retrospective study showed that survivors of lymphoma or breast cancer had a significantly greater risk of congestive heart failure (CHF) than patients who did not have cancer.

This increased risk was observed as early as a year after cancer diagnosis but was still present 20 years after diagnosis.

Overall, 1 in 10 cancer patients had CHF at the 20-year mark.

“The majority of patients do not develop heart failure, but our research helps us recognize the factors associated with it and the importance of appropriate heart care following cancer treatment,” said Carolyn Larsen, MD, of the Mayo Clinic in Rochester, Minnesota.

“Our research suggests that periodic cardiac imaging to monitor for heart damage may be needed for some cancer patients, even if they have no signs of heart damage initially after chemotherapy. Additionally, it emphasizes that working to live a heart-healthy lifestyle is important for cancer patients and survivors to reduce the overall risk of heart disease.”

Dr Larsen and her colleagues presented this research as a poster (abstract 1105-066) at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18).

Patients

Using data from the Rochester Epidemiology Project, the researchers retrospectively tracked CHF cases in 900 cancer patients and 1550 non-cancer patients. Patients were treated in Olmsted County in Minnesota from 1985 to 2010.

For both patient groups, the median age at baseline was about 53, a little more than 90% of each group was white, and nearly 80% of each group was female.

Six to 7% of patients had diabetes, and about 30% of each group had hypertension. Thirty-eight percent of each group had hyperlipidemia, and 31% were obese.

Five percent of cancer patients and 2% of controls had coronary artery disease (P<0.001). This was the only significant difference in baseline characteristics.

Cancer patients had been diagnosed with non-Hodgkin lymphoma (28%), Hodgkin lymphoma (9%), or breast cancer (64%). Forty-seven percent had received radiation, including right chest (21%), left chest (23%), and mediastinal (4%).

Eighty-four percent of patients had received anthracycline therapy. The median doxorubicin isotoxic dose was 240 mg/m².

At baseline, 12% of cancer patients were on beta-blockers, 8% were on angiotensin converting enzyme inhibitors, 4% were on angiotensin receptor blockers, and 11% were on statins.

Results

Cancer patients were more than 3 times as likely as controls to develop CHF. The hazard ratio (HR) was 3.6 (P<0.01) in an analysis adjusted for age, gender, diabetes, hypertension, coronary artery disease, dyslipidemia, and obesity at baseline.

The increased CHF risk among cancer patients was evident after the first year from cancer diagnosis and persisted at 20 years of follow-up.

“The risk of heart failure doesn’t go away after a couple of years,” Dr Larsen said. “It’s a long-term issue that patients need to discuss with their doctors and use as motivation to stay heart healthy.”

The incidence of CHF—in cancer patients and controls, respectively—was as follows:

• 1 year—1.5% vs 0.1%
• 5 years—3.1% vs 0.9%
• 10 years—5.0% vs 2%
• 20 years—10.1% vs 5.8%.

A multivariable analysis in the cancer patients revealed a few independent risk factors for CHF, including:

• Doxorubicin isotoxic dose ≥ 300 mg/m² (HR=2.34, P=0.003)
• Age at diagnosis (HR=3.06 for age ≥ 80 vs 60-69, P=0.01)
• Coronary artery disease at diagnosis (HR=2.27, P=0.04)
• Diabetes mellitus at diagnosis (HR=2.39, P<0.01).

Dr Larsen said additional research is needed to determine why diabetes carries a greater risk than other traditional risk factors, such as high blood pressure, in this group.

Mitigating risk

These findings raise important questions about what the appropriate surveillance should be for heart problems post-cancer treatment, Dr Larsen said. She believes more frequent cardiac imaging may be warranted in some patients to detect signs of CHF earlier.

“It’s an area that needs to be better defined,” Dr Larsen said. “An echocardiogram is usually done 6 to 12 months after cancer treatment with an anthracycline, but how often should it be done after that? We need to be more vigilant in making sure we try to prevent or control heart issues post-cancer care, especially in light of the growing appreciation of the connection between some cancer treatments and heart disease.”

Dr Larsen also noted that patients themselves can play a role in decreasing their risk of CHF, even if they are starting at a disadvantage.

A heart-healthy lifestyle—maintaining a normal body weight, regular exercise, and controlling other risk factors such as high blood pressure, diabetes, and high cholesterol—can help lower the risk of heart disease and CHF.

“If patients know they have received a drug treatment that might increase their risk of heart failure, it’s even more important to take care of the aspects of their life that they can control to reduce their risk as much as possible and to work with their medical care team to detect issues as early as possible,” Dr Larsen said.

Photo courtesy of CDC

ORLANDO—Results of a retrospective study showed that survivors of lymphoma or breast cancer had a significantly greater risk of congestive heart failure (CHF) than patients who did not have cancer.

This increased risk was observed as early as a year after cancer diagnosis but was still present 20 years after diagnosis.

Overall, 1 in 10 cancer patients had CHF at the 20-year mark.

“The majority of patients do not develop heart failure, but our research helps us recognize the factors associated with it and the importance of appropriate heart care following cancer treatment,” said Carolyn Larsen, MD, of the Mayo Clinic in Rochester, Minnesota.

“Our research suggests that periodic cardiac imaging to monitor for heart damage may be needed for some cancer patients, even if they have no signs of heart damage initially after chemotherapy. Additionally, it emphasizes that working to live a heart-healthy lifestyle is important for cancer patients and survivors to reduce the overall risk of heart disease.”

Dr Larsen and her colleagues presented this research as a poster (abstract 1105-066) at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18).

Patients

Using data from the Rochester Epidemiology Project, the researchers retrospectively tracked CHF cases in 900 cancer patients and 1550 non-cancer patients. Patients were treated in Olmsted County in Minnesota from 1985 to 2010.

For both patient groups, the median age at baseline was about 53, a little more than 90% of each group was white, and nearly 80% of each group was female.

Six to 7% of patients had diabetes, and about 30% of each group had hypertension. Thirty-eight percent of each group had hyperlipidemia, and 31% were obese.

Five percent of cancer patients and 2% of controls had coronary artery disease (P<0.001). This was the only significant difference in baseline characteristics.

Cancer patients had been diagnosed with non-Hodgkin lymphoma (28%), Hodgkin lymphoma (9%), or breast cancer (64%). Forty-seven percent had received radiation, including right chest (21%), left chest (23%), and mediastinal (4%).

Eighty-four percent of patients had received anthracycline therapy. The median doxorubicin isotoxic dose was 240 mg/m².

At baseline, 12% of cancer patients were on beta-blockers, 8% were on angiotensin converting enzyme inhibitors, 4% were on angiotensin receptor blockers, and 11% were on statins.

Results

Cancer patients were more than 3 times as likely as controls to develop CHF. The hazard ratio (HR) was 3.6 (P<0.01) in an analysis adjusted for age, gender, diabetes, hypertension, coronary artery disease, dyslipidemia, and obesity at baseline.

The increased CHF risk among cancer patients was evident after the first year from cancer diagnosis and persisted at 20 years of follow-up.

“The risk of heart failure doesn’t go away after a couple of years,” Dr Larsen said. “It’s a long-term issue that patients need to discuss with their doctors and use as motivation to stay heart healthy.”

The incidence of CHF—in cancer patients and controls, respectively—was as follows:

• 1 year—1.5% vs 0.1%
• 5 years—3.1% vs 0.9%
• 10 years—5.0% vs 2%
• 20 years—10.1% vs 5.8%.

A multivariable analysis in the cancer patients revealed a few independent risk factors for CHF, including:

• Doxorubicin isotoxic dose ≥ 300 mg/m² (HR=2.34, P=0.003)
• Age at diagnosis (HR=3.06 for age ≥ 80 vs 60-69, P=0.01)
• Coronary artery disease at diagnosis (HR=2.27, P=0.04)
• Diabetes mellitus at diagnosis (HR=2.39, P<0.01).

Dr Larsen said additional research is needed to determine why diabetes carries a greater risk than other traditional risk factors, such as high blood pressure, in this group.

Mitigating risk

These findings raise important questions about what the appropriate surveillance should be for heart problems post-cancer treatment, Dr Larsen said. She believes more frequent cardiac imaging may be warranted in some patients to detect signs of CHF earlier.

“It’s an area that needs to be better defined,” Dr Larsen said. “An echocardiogram is usually done 6 to 12 months after cancer treatment with an anthracycline, but how often should it be done after that? We need to be more vigilant in making sure we try to prevent or control heart issues post-cancer care, especially in light of the growing appreciation of the connection between some cancer treatments and heart disease.”

Dr Larsen also noted that patients themselves can play a role in decreasing their risk of CHF, even if they are starting at a disadvantage.

A heart-healthy lifestyle—maintaining a normal body weight, regular exercise, and controlling other risk factors such as high blood pressure, diabetes, and high cholesterol—can help lower the risk of heart disease and CHF.

“If patients know they have received a drug treatment that might increase their risk of heart failure, it’s even more important to take care of the aspects of their life that they can control to reduce their risk as much as possible and to work with their medical care team to detect issues as early as possible,” Dr Larsen said.

ANSWER

The radiograph demonstrates a fracture within the femoral neck. These types of fractures, which are slightly angulated and located at the base of the neck, are typically referred to as basicervical femur fractures. 

Prompt orthopedic surgery consultation was obtained, and the patient underwent an open reduction and internal fixation of his fracture.

ANSWER

The radiograph demonstrates a fracture within the femoral neck. These types of fractures, which are slightly angulated and located at the base of the neck, are typically referred to as basicervical femur fractures. 

Prompt orthopedic surgery consultation was obtained, and the patient underwent an open reduction and internal fixation of his fracture.

ANSWER

The radiograph demonstrates a fracture within the femoral neck. These types of fractures, which are slightly angulated and located at the base of the neck, are typically referred to as basicervical femur fractures. 

Prompt orthopedic surgery consultation was obtained, and the patient underwent an open reduction and internal fixation of his fracture.

MIAMI – Skin clearance rates among people with moderate to severe plaque psoriasis treated with brodalumab were superior to clearance rates among those treated with ustekinumab in a study that also provided comparisons between white and nonwhite patients.

In the study, presented in a poster at the 2018 Orlando Dermatology Aesthetic and Clinical Conference, there were no significant difference in overall efficacy, safety, or health-related quality of life outcomes between white and nonwhite patients treated with either biologic.

Additional analyses specific to patients with skin of color can be beneficial, Amy McMichael, MD, one of the investigators, said in an interview. “Patients with skin of color experience differences in psoriasis-related symptoms,” noted Dr. McMichael, chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. “Greater degrees of skin involvement have been shown in African-American patients, as have differences in erythema, scaling, dyspigmentation, and plaque thickness.”

She and her colleagues evaluated 1,849 participants in phase 3 brodalumab clinical trials, which included ustekinumab-treated patients as a comparison group. Approximately 10% of the AMAGINE-2 and AMAGINE-3 study populations were skin of color participants. The results reported at the meeting were from their ad hoc study of 12-week induction findings from the 52-week clinical trials.

[email protected]

SOURCE: McMichael A et al. ODAC 2018.

MIAMI – Skin clearance rates among people with moderate to severe plaque psoriasis treated with brodalumab were superior to clearance rates among those treated with ustekinumab in a study that also provided comparisons between white and nonwhite patients.

In the study, presented in a poster at the 2018 Orlando Dermatology Aesthetic and Clinical Conference, there were no significant difference in overall efficacy, safety, or health-related quality of life outcomes between white and nonwhite patients treated with either biologic.

Additional analyses specific to patients with skin of color can be beneficial, Amy McMichael, MD, one of the investigators, said in an interview. “Patients with skin of color experience differences in psoriasis-related symptoms,” noted Dr. McMichael, chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. “Greater degrees of skin involvement have been shown in African-American patients, as have differences in erythema, scaling, dyspigmentation, and plaque thickness.”

She and her colleagues evaluated 1,849 participants in phase 3 brodalumab clinical trials, which included ustekinumab-treated patients as a comparison group. Approximately 10% of the AMAGINE-2 and AMAGINE-3 study populations were skin of color participants. The results reported at the meeting were from their ad hoc study of 12-week induction findings from the 52-week clinical trials.

[email protected]

SOURCE: McMichael A et al. ODAC 2018.

MIAMI – Skin clearance rates among people with moderate to severe plaque psoriasis treated with brodalumab were superior to clearance rates among those treated with ustekinumab in a study that also provided comparisons between white and nonwhite patients.

In the study, presented in a poster at the 2018 Orlando Dermatology Aesthetic and Clinical Conference, there were no significant difference in overall efficacy, safety, or health-related quality of life outcomes between white and nonwhite patients treated with either biologic.

Additional analyses specific to patients with skin of color can be beneficial, Amy McMichael, MD, one of the investigators, said in an interview. “Patients with skin of color experience differences in psoriasis-related symptoms,” noted Dr. McMichael, chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. “Greater degrees of skin involvement have been shown in African-American patients, as have differences in erythema, scaling, dyspigmentation, and plaque thickness.”

She and her colleagues evaluated 1,849 participants in phase 3 brodalumab clinical trials, which included ustekinumab-treated patients as a comparison group. Approximately 10% of the AMAGINE-2 and AMAGINE-3 study populations were skin of color participants. The results reported at the meeting were from their ad hoc study of 12-week induction findings from the 52-week clinical trials.

[email protected]

SOURCE: McMichael A et al. ODAC 2018.

Even if you have never experienced a symptom of burnout, you probably have at least one colleague who has. In the last decade, collateral damage from physician burnout has earned it a place on the agenda of the American Academy of Pediatrics and most other physician organizations.

When one steps back and takes a longer view, burnout is simply a poor fit between physicians and their roles. An increasing number of physicians are finding themselves in jobs in which – for a variety of reasons – they feel uncomfortable. Eventually, the discomfort resulting from that poor fit becomes so unbearable the only solution is to change jobs or retire.

monkeybusinessimages/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Even if you have never experienced a symptom of burnout, you probably have at least one colleague who has. In the last decade, collateral damage from physician burnout has earned it a place on the agenda of the American Academy of Pediatrics and most other physician organizations.

When one steps back and takes a longer view, burnout is simply a poor fit between physicians and their roles. An increasing number of physicians are finding themselves in jobs in which – for a variety of reasons – they feel uncomfortable. Eventually, the discomfort resulting from that poor fit becomes so unbearable the only solution is to change jobs or retire.

monkeybusinessimages/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Even if you have never experienced a symptom of burnout, you probably have at least one colleague who has. In the last decade, collateral damage from physician burnout has earned it a place on the agenda of the American Academy of Pediatrics and most other physician organizations.

When one steps back and takes a longer view, burnout is simply a poor fit between physicians and their roles. An increasing number of physicians are finding themselves in jobs in which – for a variety of reasons – they feel uncomfortable. Eventually, the discomfort resulting from that poor fit becomes so unbearable the only solution is to change jobs or retire.

monkeybusinessimages/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

ORLANDO – Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y₁₂ inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y₁₂-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.

All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

ORLANDO – Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y₁₂ inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y₁₂-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.

All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

ORLANDO – Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y₁₂ inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y₁₂-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.

All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

ORLANDO – Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.

“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.

“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.

The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.

[email protected]

SOURCE: Victor R et al. ACC 2018.

ORLANDO – Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.

“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.

“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.

The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.

[email protected]

SOURCE: Victor R et al. ACC 2018.

ORLANDO – Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.

“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.

“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.

The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.

[email protected]

SOURCE: Victor R et al. ACC 2018.

ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

[email protected]

SOURCE: Devereaux P et al. ACC 18.

ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

[email protected]

SOURCE: Devereaux P et al. ACC 18.

ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

[email protected]

SOURCE: Devereaux P et al. ACC 18.