The Food and Drug Administration has granted accelerated approval to venetoclax for use in acute myeloid leukemia (AML).

The BCL-2 inhibitor is now approved for use in combination with azacitidine, decitabine, or low-dose cytarabine to treat newly diagnosed adults with AML who are aged 75 and older or who are ineligible for intensive chemotherapy.

The FDA grants accelerated approval based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Continued approval of venetoclax in AML may be contingent upon verification of clinical benefit in confirmatory trials.

The approval is based on data from two studies – the phase 1b M14-358 trial ( NCT02203773 ) and the phase 1/2 M14-387 trial ( NCT02287233 ).

In M14-358, newly diagnosed AML patients received venetoclax in combination with azacitidine (n=84) or decitabine (n=31). There were 67 patients in the azacitidine arm and 13 in the decitabine arm who were aged 75 or older or were ineligible for intensive induction chemotherapy.

Patients received venetoclax via a daily ramp-up to a final dose of 400 mg once daily. They received prophylaxis for tumor lysis syndrome and were hospitalized for monitoring during the ramp-up.

They received azacitidine at 75 mg/m ² on days 1-7 of each 28-day cycle or decitabine at 20 mg/m ² on days 1-5 of each cycle. Patients continued treatment until disease progression or unacceptable toxicity.

The median follow-up was 7.9 months for the azacitidine arm and 11 months for the decitabine arm.

The complete response (CR) rate was 37% (25/67) in the azacitidine arm and 54% (7/13) in the decitabine arm. The rates of CR with partial hematologic recovery were 24% (16/67) and 7.7% (1/13), respectively. The most common adverse events (AEs) – occurring in at least 30% of patients in both arms – were nausea, diarrhea, constipation, neutropenia, thrombocytopenia, hemorrhage, peripheral edema, vomiting, fatigue, febrile neutropenia, rash, and anemia. The incidence of serious AEs was 75% overall. The most frequent serious AEs (occurring in at least 5% of patients) were febrile neutropenia, pneumonia (excluding fungal), sepsis (excluding fungal), respiratory failure, and multiple organ dysfunction syndrome. The incidence of fatal AEs was 1.5% within 30 days of treatment initiation. The M14-387 trial included 82 AML patients who received venetoclax plus low-dose cytarabine. Patients were newly diagnosed with AML, but some had previous exposure to a hypomethylating agent for an antecedent hematologic disorder.

There were 61 patients who were aged 75 or older or were ineligible for intensive induction chemotherapy.

Patients received venetoclax via daily ramp-up to a final dose of 600 mg once daily. They received prophylaxis for tumor lysis syndrome and were hospitalized for monitoring during the ramp-up.

Cytarabine was given at 20 mg/m ² on days 1-10 of each 28-day cycle. Patients continued to receive treatment until disease progression or unacceptable toxicity.

At a median follow-up of 6.5 months, the CR rate was 21% (13/61), and the rate of CR with partial hematologic recovery was 21% (13/61).

The most common AEs (occurring in at least 30% of patients) were nausea, thrombocytopenia, hemorrhage, febrile neutropenia, neutropenia, diarrhea, fatigue, constipation, and dyspnea. The incidence of serious AEs was 95%. The most frequent serious AEs (occurring in at least 5% of patients) were febrile neutropenia, sepsis (excluding fungal), hemorrhage, pneumonia (excluding fungal), and device-related infection. The incidence of fatal AEs was 4.9% within 30 days of treatment initiation.

Additional details from the M14-358 and M14-387 trials are available in the prescribing information for venetoclax.

Venetoclax is being developed by AbbVie and Roche.

[email protected]

The Food and Drug Administration has granted accelerated approval to venetoclax for use in acute myeloid leukemia (AML).

The BCL-2 inhibitor is now approved for use in combination with azacitidine, decitabine, or low-dose cytarabine to treat newly diagnosed adults with AML who are aged 75 and older or who are ineligible for intensive chemotherapy.

The FDA grants accelerated approval based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Continued approval of venetoclax in AML may be contingent upon verification of clinical benefit in confirmatory trials.

The approval is based on data from two studies – the phase 1b M14-358 trial ( NCT02203773 ) and the phase 1/2 M14-387 trial ( NCT02287233 ).

In M14-358, newly diagnosed AML patients received venetoclax in combination with azacitidine (n=84) or decitabine (n=31). There were 67 patients in the azacitidine arm and 13 in the decitabine arm who were aged 75 or older or were ineligible for intensive induction chemotherapy.

Patients received venetoclax via a daily ramp-up to a final dose of 400 mg once daily. They received prophylaxis for tumor lysis syndrome and were hospitalized for monitoring during the ramp-up.

They received azacitidine at 75 mg/m ² on days 1-7 of each 28-day cycle or decitabine at 20 mg/m ² on days 1-5 of each cycle. Patients continued treatment until disease progression or unacceptable toxicity.

The median follow-up was 7.9 months for the azacitidine arm and 11 months for the decitabine arm.

The complete response (CR) rate was 37% (25/67) in the azacitidine arm and 54% (7/13) in the decitabine arm. The rates of CR with partial hematologic recovery were 24% (16/67) and 7.7% (1/13), respectively. The most common adverse events (AEs) – occurring in at least 30% of patients in both arms – were nausea, diarrhea, constipation, neutropenia, thrombocytopenia, hemorrhage, peripheral edema, vomiting, fatigue, febrile neutropenia, rash, and anemia. The incidence of serious AEs was 75% overall. The most frequent serious AEs (occurring in at least 5% of patients) were febrile neutropenia, pneumonia (excluding fungal), sepsis (excluding fungal), respiratory failure, and multiple organ dysfunction syndrome. The incidence of fatal AEs was 1.5% within 30 days of treatment initiation. The M14-387 trial included 82 AML patients who received venetoclax plus low-dose cytarabine. Patients were newly diagnosed with AML, but some had previous exposure to a hypomethylating agent for an antecedent hematologic disorder.

There were 61 patients who were aged 75 or older or were ineligible for intensive induction chemotherapy.

Patients received venetoclax via daily ramp-up to a final dose of 600 mg once daily. They received prophylaxis for tumor lysis syndrome and were hospitalized for monitoring during the ramp-up.

Cytarabine was given at 20 mg/m ² on days 1-10 of each 28-day cycle. Patients continued to receive treatment until disease progression or unacceptable toxicity.

At a median follow-up of 6.5 months, the CR rate was 21% (13/61), and the rate of CR with partial hematologic recovery was 21% (13/61).

The most common AEs (occurring in at least 30% of patients) were nausea, thrombocytopenia, hemorrhage, febrile neutropenia, neutropenia, diarrhea, fatigue, constipation, and dyspnea. The incidence of serious AEs was 95%. The most frequent serious AEs (occurring in at least 5% of patients) were febrile neutropenia, sepsis (excluding fungal), hemorrhage, pneumonia (excluding fungal), and device-related infection. The incidence of fatal AEs was 4.9% within 30 days of treatment initiation.

Additional details from the M14-358 and M14-387 trials are available in the prescribing information for venetoclax.

Venetoclax is being developed by AbbVie and Roche.

[email protected]

The Food and Drug Administration has granted accelerated approval to venetoclax for use in acute myeloid leukemia (AML).

The BCL-2 inhibitor is now approved for use in combination with azacitidine, decitabine, or low-dose cytarabine to treat newly diagnosed adults with AML who are aged 75 and older or who are ineligible for intensive chemotherapy.

The FDA grants accelerated approval based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Continued approval of venetoclax in AML may be contingent upon verification of clinical benefit in confirmatory trials.

The approval is based on data from two studies – the phase 1b M14-358 trial ( NCT02203773 ) and the phase 1/2 M14-387 trial ( NCT02287233 ).

In M14-358, newly diagnosed AML patients received venetoclax in combination with azacitidine (n=84) or decitabine (n=31). There were 67 patients in the azacitidine arm and 13 in the decitabine arm who were aged 75 or older or were ineligible for intensive induction chemotherapy.

Patients received venetoclax via a daily ramp-up to a final dose of 400 mg once daily. They received prophylaxis for tumor lysis syndrome and were hospitalized for monitoring during the ramp-up.

They received azacitidine at 75 mg/m ² on days 1-7 of each 28-day cycle or decitabine at 20 mg/m ² on days 1-5 of each cycle. Patients continued treatment until disease progression or unacceptable toxicity.

The median follow-up was 7.9 months for the azacitidine arm and 11 months for the decitabine arm.

The complete response (CR) rate was 37% (25/67) in the azacitidine arm and 54% (7/13) in the decitabine arm. The rates of CR with partial hematologic recovery were 24% (16/67) and 7.7% (1/13), respectively. The most common adverse events (AEs) – occurring in at least 30% of patients in both arms – were nausea, diarrhea, constipation, neutropenia, thrombocytopenia, hemorrhage, peripheral edema, vomiting, fatigue, febrile neutropenia, rash, and anemia. The incidence of serious AEs was 75% overall. The most frequent serious AEs (occurring in at least 5% of patients) were febrile neutropenia, pneumonia (excluding fungal), sepsis (excluding fungal), respiratory failure, and multiple organ dysfunction syndrome. The incidence of fatal AEs was 1.5% within 30 days of treatment initiation. The M14-387 trial included 82 AML patients who received venetoclax plus low-dose cytarabine. Patients were newly diagnosed with AML, but some had previous exposure to a hypomethylating agent for an antecedent hematologic disorder.

There were 61 patients who were aged 75 or older or were ineligible for intensive induction chemotherapy.

Patients received venetoclax via daily ramp-up to a final dose of 600 mg once daily. They received prophylaxis for tumor lysis syndrome and were hospitalized for monitoring during the ramp-up.

Cytarabine was given at 20 mg/m ² on days 1-10 of each 28-day cycle. Patients continued to receive treatment until disease progression or unacceptable toxicity.

At a median follow-up of 6.5 months, the CR rate was 21% (13/61), and the rate of CR with partial hematologic recovery was 21% (13/61).

The most common AEs (occurring in at least 30% of patients) were nausea, thrombocytopenia, hemorrhage, febrile neutropenia, neutropenia, diarrhea, fatigue, constipation, and dyspnea. The incidence of serious AEs was 95%. The most frequent serious AEs (occurring in at least 5% of patients) were febrile neutropenia, sepsis (excluding fungal), hemorrhage, pneumonia (excluding fungal), and device-related infection. The incidence of fatal AEs was 4.9% within 30 days of treatment initiation.

Additional details from the M14-358 and M14-387 trials are available in the prescribing information for venetoclax.

Venetoclax is being developed by AbbVie and Roche.

[email protected]

In the closest thing the medical world has to movie trailers, the American Society of Hematology held a press conference offering a peek into the much anticipated (and much hyped) clinical and research abstracts that will be presented at the 2018 ASH annual meeting.

Shorter R-CHOP regimen for DLBCL

Under the heading “Big Trials, Big Results” will be data from the FLYER trial, a phase 3, randomized, deescalation trial in 592 patients aged 18-60 years with favorable-prognosis diffuse large B-cell lymphoma. The investigators report that both progression-free survival and overall survival with four cycles of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) were noninferior to those for patients treated with six cycles of R-CHOP (abstract 781).

Ibrutinib mastery in CLL

Also on the program are results of a study showing that ibrutinib (Imbruvica), either alone or in combination with rituximab, is associated with superior progression-free survival than bendamustine and rituximab in older patients with chronic lymphocytic leukemia (CLL).

The trial, the Alliance North American Intergroup Study A041202 (abstract 6) is the first major trial to pit ibrutinib against the modern standard of immunochemotherapy rather than the older standard of chlorambucil, Dr. Brodsky noted.

Anemia support in beta-thalassemia, MDS

In nonmalignant disease, investigators in the randomized, phase 3 BELIEVE trial are reporting results of their study showing that the first-in-class erythroid maturation agent luspatercept was associated with significant reductions in the need for RBC transfusion in adults with transfusion-dependent beta-thalassemia.

The investigators report that the experimental agent was “generally well tolerated” (abstract 163).

“Beyond a proof of principle, [this is] certainly a very exciting advancement in this group of patients who otherwise had very few treatment options,” said Alexis A. Thompson, MD, associate director of equity and minority health at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, and the current ASH president.

Dr. Thompson also highlighted the MEDALIST trial (abstract 1), a phase 3, randomized study showing that luspatercept significantly reduced transfusion burden, compared with placebo, in patients with anemia caused by very low–, low-, or intermediate-risk myelodysplastic syndrome with ring sideroblasts who require RBC transfusions.

“This group of patients were individuals who were refractory or were not responders or did not tolerate erythropoietic stimulating agents and therefore were requiring regular transfusion,” Dr. Thompson said.

Worth the wait

The late-breaking abstract program was stretched from the usual six abstracts to seven this year because of the unusually high quality of the science, Dr. Brodsky said.

Among these star attractions are results of a phase 3, randomized study of daratumumab (Darzalex) plus lenalidomide and dexamethasone versus lenalidomide-dexamethasone alone for patients with newly diagnosed multiple myeloma who are ineligible for transplant.

The investigators found that adding daratumumab reduced the risk of disease progression or death by close to 50%, supporting the combination as a new standard of care in these patients, according to Thierry Facon, MD, from the Hospital Claude Huriez in Lille, France, and colleagues (abstract LBA-2).

Two other late-breakers deal with CLL. The first, a randomized, phase 3 study of ibrutinib-based therapy versus standard fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy in younger patients with untreated CLL, found that ibrutinib and rituximab provided significantly better progression-free survival and overall survival (abstract LBA-4).

“These findings have immediate practice-changing implications and establish ibrutinib-based therapy as the most efficacious first-line therapy for patients with CLL,” wrote Tait D. Shanafelt, MD, from Stanford (Calif.) University, and colleagues.

On a less positive note, Australian researchers report their discovery of a recurrent mutation in BCL2 that confers resistance to venetoclax (Venclexta) in patients with progressive CLL (abstract LBA-7).

“This mutation provides new insights into the pathobiology of venetoclax resistance and provides a potential biomarker of impending clinical relapse,” wrote Piers Blombery, MBBS, from the University of Melbourne, and colleagues.

Finally, investigators from children’s hospitals in the United States and Europe report promising findings on the safety and efficacy of emapalumab for the treatment of patients with the rare genetic disorder primary hemophagocytic lymphohistiocytosis (HLH).

The drug, newly approved by the Food and Drug Administration, was able to control HLH’s hyperinflammatory activity, and allowed a substantial proportion of patients to survive to hematopoietic stem cell transplantation, the investigators said (abstract LBA-6­).

In the closest thing the medical world has to movie trailers, the American Society of Hematology held a press conference offering a peek into the much anticipated (and much hyped) clinical and research abstracts that will be presented at the 2018 ASH annual meeting.

Shorter R-CHOP regimen for DLBCL

Under the heading “Big Trials, Big Results” will be data from the FLYER trial, a phase 3, randomized, deescalation trial in 592 patients aged 18-60 years with favorable-prognosis diffuse large B-cell lymphoma. The investigators report that both progression-free survival and overall survival with four cycles of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) were noninferior to those for patients treated with six cycles of R-CHOP (abstract 781).

Ibrutinib mastery in CLL

Also on the program are results of a study showing that ibrutinib (Imbruvica), either alone or in combination with rituximab, is associated with superior progression-free survival than bendamustine and rituximab in older patients with chronic lymphocytic leukemia (CLL).

The trial, the Alliance North American Intergroup Study A041202 (abstract 6) is the first major trial to pit ibrutinib against the modern standard of immunochemotherapy rather than the older standard of chlorambucil, Dr. Brodsky noted.

Anemia support in beta-thalassemia, MDS

In nonmalignant disease, investigators in the randomized, phase 3 BELIEVE trial are reporting results of their study showing that the first-in-class erythroid maturation agent luspatercept was associated with significant reductions in the need for RBC transfusion in adults with transfusion-dependent beta-thalassemia.

The investigators report that the experimental agent was “generally well tolerated” (abstract 163).

“Beyond a proof of principle, [this is] certainly a very exciting advancement in this group of patients who otherwise had very few treatment options,” said Alexis A. Thompson, MD, associate director of equity and minority health at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, and the current ASH president.

Dr. Thompson also highlighted the MEDALIST trial (abstract 1), a phase 3, randomized study showing that luspatercept significantly reduced transfusion burden, compared with placebo, in patients with anemia caused by very low–, low-, or intermediate-risk myelodysplastic syndrome with ring sideroblasts who require RBC transfusions.

“This group of patients were individuals who were refractory or were not responders or did not tolerate erythropoietic stimulating agents and therefore were requiring regular transfusion,” Dr. Thompson said.

Worth the wait

The late-breaking abstract program was stretched from the usual six abstracts to seven this year because of the unusually high quality of the science, Dr. Brodsky said.

Among these star attractions are results of a phase 3, randomized study of daratumumab (Darzalex) plus lenalidomide and dexamethasone versus lenalidomide-dexamethasone alone for patients with newly diagnosed multiple myeloma who are ineligible for transplant.

The investigators found that adding daratumumab reduced the risk of disease progression or death by close to 50%, supporting the combination as a new standard of care in these patients, according to Thierry Facon, MD, from the Hospital Claude Huriez in Lille, France, and colleagues (abstract LBA-2).

Two other late-breakers deal with CLL. The first, a randomized, phase 3 study of ibrutinib-based therapy versus standard fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy in younger patients with untreated CLL, found that ibrutinib and rituximab provided significantly better progression-free survival and overall survival (abstract LBA-4).

“These findings have immediate practice-changing implications and establish ibrutinib-based therapy as the most efficacious first-line therapy for patients with CLL,” wrote Tait D. Shanafelt, MD, from Stanford (Calif.) University, and colleagues.

On a less positive note, Australian researchers report their discovery of a recurrent mutation in BCL2 that confers resistance to venetoclax (Venclexta) in patients with progressive CLL (abstract LBA-7).

“This mutation provides new insights into the pathobiology of venetoclax resistance and provides a potential biomarker of impending clinical relapse,” wrote Piers Blombery, MBBS, from the University of Melbourne, and colleagues.

Finally, investigators from children’s hospitals in the United States and Europe report promising findings on the safety and efficacy of emapalumab for the treatment of patients with the rare genetic disorder primary hemophagocytic lymphohistiocytosis (HLH).

The drug, newly approved by the Food and Drug Administration, was able to control HLH’s hyperinflammatory activity, and allowed a substantial proportion of patients to survive to hematopoietic stem cell transplantation, the investigators said (abstract LBA-6­).

In the closest thing the medical world has to movie trailers, the American Society of Hematology held a press conference offering a peek into the much anticipated (and much hyped) clinical and research abstracts that will be presented at the 2018 ASH annual meeting.

Shorter R-CHOP regimen for DLBCL

Under the heading “Big Trials, Big Results” will be data from the FLYER trial, a phase 3, randomized, deescalation trial in 592 patients aged 18-60 years with favorable-prognosis diffuse large B-cell lymphoma. The investigators report that both progression-free survival and overall survival with four cycles of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) were noninferior to those for patients treated with six cycles of R-CHOP (abstract 781).

Ibrutinib mastery in CLL

Also on the program are results of a study showing that ibrutinib (Imbruvica), either alone or in combination with rituximab, is associated with superior progression-free survival than bendamustine and rituximab in older patients with chronic lymphocytic leukemia (CLL).

The trial, the Alliance North American Intergroup Study A041202 (abstract 6) is the first major trial to pit ibrutinib against the modern standard of immunochemotherapy rather than the older standard of chlorambucil, Dr. Brodsky noted.

Anemia support in beta-thalassemia, MDS

In nonmalignant disease, investigators in the randomized, phase 3 BELIEVE trial are reporting results of their study showing that the first-in-class erythroid maturation agent luspatercept was associated with significant reductions in the need for RBC transfusion in adults with transfusion-dependent beta-thalassemia.

The investigators report that the experimental agent was “generally well tolerated” (abstract 163).

“Beyond a proof of principle, [this is] certainly a very exciting advancement in this group of patients who otherwise had very few treatment options,” said Alexis A. Thompson, MD, associate director of equity and minority health at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, and the current ASH president.

Dr. Thompson also highlighted the MEDALIST trial (abstract 1), a phase 3, randomized study showing that luspatercept significantly reduced transfusion burden, compared with placebo, in patients with anemia caused by very low–, low-, or intermediate-risk myelodysplastic syndrome with ring sideroblasts who require RBC transfusions.

“This group of patients were individuals who were refractory or were not responders or did not tolerate erythropoietic stimulating agents and therefore were requiring regular transfusion,” Dr. Thompson said.

Worth the wait

The late-breaking abstract program was stretched from the usual six abstracts to seven this year because of the unusually high quality of the science, Dr. Brodsky said.

Among these star attractions are results of a phase 3, randomized study of daratumumab (Darzalex) plus lenalidomide and dexamethasone versus lenalidomide-dexamethasone alone for patients with newly diagnosed multiple myeloma who are ineligible for transplant.

The investigators found that adding daratumumab reduced the risk of disease progression or death by close to 50%, supporting the combination as a new standard of care in these patients, according to Thierry Facon, MD, from the Hospital Claude Huriez in Lille, France, and colleagues (abstract LBA-2).

Two other late-breakers deal with CLL. The first, a randomized, phase 3 study of ibrutinib-based therapy versus standard fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy in younger patients with untreated CLL, found that ibrutinib and rituximab provided significantly better progression-free survival and overall survival (abstract LBA-4).

“These findings have immediate practice-changing implications and establish ibrutinib-based therapy as the most efficacious first-line therapy for patients with CLL,” wrote Tait D. Shanafelt, MD, from Stanford (Calif.) University, and colleagues.

On a less positive note, Australian researchers report their discovery of a recurrent mutation in BCL2 that confers resistance to venetoclax (Venclexta) in patients with progressive CLL (abstract LBA-7).

“This mutation provides new insights into the pathobiology of venetoclax resistance and provides a potential biomarker of impending clinical relapse,” wrote Piers Blombery, MBBS, from the University of Melbourne, and colleagues.

Finally, investigators from children’s hospitals in the United States and Europe report promising findings on the safety and efficacy of emapalumab for the treatment of patients with the rare genetic disorder primary hemophagocytic lymphohistiocytosis (HLH).

The drug, newly approved by the Food and Drug Administration, was able to control HLH’s hyperinflammatory activity, and allowed a substantial proportion of patients to survive to hematopoietic stem cell transplantation, the investigators said (abstract LBA-6­).

Three important national measures of abortion dropped by at least 19% from 2006 to 2015, according to the Centers for Disease Control and Prevention.

Surgical and medical abortions reported to the CDC dropped by 24%, going from almost 843,000 in 2006 to 638,000 in 2015, with declines occurring every year, Tara C. Jatlaoui, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, reported in Morbidity and Mortality Weekly Report Surveillance Summaries.

Over that same time period, the abortion rate fell from 15.9 per 1,000 women aged 15-44 years to 11.8 per 1,000 – a decline of 26%. Abortion ratio – the number of abortions per 1,000 live births within a given population – declined by 19%, dropping from 233 abortions per 1,000 live births in 2006 to 188 abortions per 1,000 live births in 2015, the investigators reported. The findings were based on data from 49 areas that continuously reported over the study period (excludes California, Maryland, and New Hampshire but includes the District of Columbia and New York City).

Abortion rates were highest for women aged 20-29 years for the study period, and this age group accounted for the largest share among the 44 reporting areas that provided data by maternal age each year. Those under age 15 years had the largest drops by age in total number of abortions (40%) and abortion rate (58%) but had the highest, by far, abortion ratio for each year of the study (700 per 1,000 live births in that age group in 2015. The abortion ratio for 15- to 19-year-olds was 289 per 1,000 live births).

The percentage of abortions performed before 14 weeks’ gestation changed little, going from 91.5% in 2006 to 91% in 2015, but “a shift occurred toward earlier gestational ages,” they noted. The percentage of abortions performed before or at 8 weeks increased 3% and those done at 9-13 weeks dropped almost 9% among the 33 areas that reported gestational age every year. Abortions done after 13 weeks gestation represented 9% of all abortions during the study period, with an increase of 7% occurring from 2006 to 2015, Dr. Jatlaoui and her associates said.

Removing barriers such as cost, “insufficient provider reimbursement and training, inadequate client-centered counseling, lack of youth-friendly services, and low client awareness ... might help improve contraceptive use, potentially reducing the number of unintended pregnancies and the number of abortions performed in the United States,” the researchers wrote.

[email protected]

SOURCE: Jatlaoui TC et al. MMWR Surveill Summ. 2018 Nov 23(13):1-45.

Three important national measures of abortion dropped by at least 19% from 2006 to 2015, according to the Centers for Disease Control and Prevention.

Surgical and medical abortions reported to the CDC dropped by 24%, going from almost 843,000 in 2006 to 638,000 in 2015, with declines occurring every year, Tara C. Jatlaoui, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, reported in Morbidity and Mortality Weekly Report Surveillance Summaries.

Over that same time period, the abortion rate fell from 15.9 per 1,000 women aged 15-44 years to 11.8 per 1,000 – a decline of 26%. Abortion ratio – the number of abortions per 1,000 live births within a given population – declined by 19%, dropping from 233 abortions per 1,000 live births in 2006 to 188 abortions per 1,000 live births in 2015, the investigators reported. The findings were based on data from 49 areas that continuously reported over the study period (excludes California, Maryland, and New Hampshire but includes the District of Columbia and New York City).

Abortion rates were highest for women aged 20-29 years for the study period, and this age group accounted for the largest share among the 44 reporting areas that provided data by maternal age each year. Those under age 15 years had the largest drops by age in total number of abortions (40%) and abortion rate (58%) but had the highest, by far, abortion ratio for each year of the study (700 per 1,000 live births in that age group in 2015. The abortion ratio for 15- to 19-year-olds was 289 per 1,000 live births).

The percentage of abortions performed before 14 weeks’ gestation changed little, going from 91.5% in 2006 to 91% in 2015, but “a shift occurred toward earlier gestational ages,” they noted. The percentage of abortions performed before or at 8 weeks increased 3% and those done at 9-13 weeks dropped almost 9% among the 33 areas that reported gestational age every year. Abortions done after 13 weeks gestation represented 9% of all abortions during the study period, with an increase of 7% occurring from 2006 to 2015, Dr. Jatlaoui and her associates said.

Removing barriers such as cost, “insufficient provider reimbursement and training, inadequate client-centered counseling, lack of youth-friendly services, and low client awareness ... might help improve contraceptive use, potentially reducing the number of unintended pregnancies and the number of abortions performed in the United States,” the researchers wrote.

[email protected]

SOURCE: Jatlaoui TC et al. MMWR Surveill Summ. 2018 Nov 23(13):1-45.

Three important national measures of abortion dropped by at least 19% from 2006 to 2015, according to the Centers for Disease Control and Prevention.

Surgical and medical abortions reported to the CDC dropped by 24%, going from almost 843,000 in 2006 to 638,000 in 2015, with declines occurring every year, Tara C. Jatlaoui, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, reported in Morbidity and Mortality Weekly Report Surveillance Summaries.

Over that same time period, the abortion rate fell from 15.9 per 1,000 women aged 15-44 years to 11.8 per 1,000 – a decline of 26%. Abortion ratio – the number of abortions per 1,000 live births within a given population – declined by 19%, dropping from 233 abortions per 1,000 live births in 2006 to 188 abortions per 1,000 live births in 2015, the investigators reported. The findings were based on data from 49 areas that continuously reported over the study period (excludes California, Maryland, and New Hampshire but includes the District of Columbia and New York City).

Abortion rates were highest for women aged 20-29 years for the study period, and this age group accounted for the largest share among the 44 reporting areas that provided data by maternal age each year. Those under age 15 years had the largest drops by age in total number of abortions (40%) and abortion rate (58%) but had the highest, by far, abortion ratio for each year of the study (700 per 1,000 live births in that age group in 2015. The abortion ratio for 15- to 19-year-olds was 289 per 1,000 live births).

The percentage of abortions performed before 14 weeks’ gestation changed little, going from 91.5% in 2006 to 91% in 2015, but “a shift occurred toward earlier gestational ages,” they noted. The percentage of abortions performed before or at 8 weeks increased 3% and those done at 9-13 weeks dropped almost 9% among the 33 areas that reported gestational age every year. Abortions done after 13 weeks gestation represented 9% of all abortions during the study period, with an increase of 7% occurring from 2006 to 2015, Dr. Jatlaoui and her associates said.

Removing barriers such as cost, “insufficient provider reimbursement and training, inadequate client-centered counseling, lack of youth-friendly services, and low client awareness ... might help improve contraceptive use, potentially reducing the number of unintended pregnancies and the number of abortions performed in the United States,” the researchers wrote.

[email protected]

SOURCE: Jatlaoui TC et al. MMWR Surveill Summ. 2018 Nov 23(13):1-45.

Mylan has announced that it is voluntarily recalling 15 lots of products containing valsartan because of the detection of trace amounts of N-nitrosodiethylamine within the active ingredient, according to a company announcement posted on the website of the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The affected products include six lots of amlodipine/valsartan tablets (5-mg/160-mg, 10-mg/160-mg, and 10-mg/320-mg strengths), seven lots of valsartan tablets (40-mg, 80-mg, 160-mg, and 320-mg strengths), and two lots of valsartan/hydrochlorothiazide tablets (320-mg/25-mg strength). All products were distributed between March 2017 and November 2018.

“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the company statement said.

N-nitrosodiethylamine is a naturally occurring substance that has been identified as a human carcinogen by the International Agency for Research on Cancer.

The lot and NDC (National Drug Code) numbers of the affected products can be found in the full press release on the FDA website.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday, 8 a.m. to 5 p.m. EST, according to the statement.

[email protected]

Mylan has announced that it is voluntarily recalling 15 lots of products containing valsartan because of the detection of trace amounts of N-nitrosodiethylamine within the active ingredient, according to a company announcement posted on the website of the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The affected products include six lots of amlodipine/valsartan tablets (5-mg/160-mg, 10-mg/160-mg, and 10-mg/320-mg strengths), seven lots of valsartan tablets (40-mg, 80-mg, 160-mg, and 320-mg strengths), and two lots of valsartan/hydrochlorothiazide tablets (320-mg/25-mg strength). All products were distributed between March 2017 and November 2018.

“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the company statement said.

N-nitrosodiethylamine is a naturally occurring substance that has been identified as a human carcinogen by the International Agency for Research on Cancer.

The lot and NDC (National Drug Code) numbers of the affected products can be found in the full press release on the FDA website.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday, 8 a.m. to 5 p.m. EST, according to the statement.

[email protected]

Mylan has announced that it is voluntarily recalling 15 lots of products containing valsartan because of the detection of trace amounts of N-nitrosodiethylamine within the active ingredient, according to a company announcement posted on the website of the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The affected products include six lots of amlodipine/valsartan tablets (5-mg/160-mg, 10-mg/160-mg, and 10-mg/320-mg strengths), seven lots of valsartan tablets (40-mg, 80-mg, 160-mg, and 320-mg strengths), and two lots of valsartan/hydrochlorothiazide tablets (320-mg/25-mg strength). All products were distributed between March 2017 and November 2018.

“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the company statement said.

N-nitrosodiethylamine is a naturally occurring substance that has been identified as a human carcinogen by the International Agency for Research on Cancer.

The lot and NDC (National Drug Code) numbers of the affected products can be found in the full press release on the FDA website.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday, 8 a.m. to 5 p.m. EST, according to the statement.

[email protected]

NASHVILLE – After bariatric surgery, individuals are at increased risk of suicide and self-harm, according to findings from a meta-analysis presented at the meeting.

Kari Oakes/MDedge News

Overall, the odds ratio was 1.69 for self-harm or suicide after bariatric surgery (95% confidence interval, 1.62-1.76; P less than .001), “indicating a nearly 70% increase in risk for self-harm or suicide following bariatric surgery,” wrote Dawn Roberts, PhD, of Bradley University, Peoria, Ill., and her coauthor, Nicole Pearl of Washington University, St. Louis, in the poster accompanying the presentation.

Further, as elapsed time from surgery grew, the suicide rate dropped (effect size covariance, r = –0.25). “Thus, the greatest risk for self-harm or suicide appears to emerge in the years immediately following surgery,” Dr. Roberts said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The investigators had a primary objective of characterizing the association between bariatric surgery and suicide or self-harm. The secondary purpose of the meta-analysis was to find moderators of the association that could explain some of the variability that had previously been seen in studies looking at mental health outcomes after bariatric surgery.

Some of the potential moderators, explained the investigators, included the surgery type. With Roux-en-Y gastric bypass (RYGB), more tissue is removed, potentially causing “more extensive disruption of neural pathways,” the investigators wrote. With greater loss of small-intestine surface area might come more disruption of the gut-brain axis, along with unknown effects on metabolism and pharmacokinetics of psychiatric medication. Additionally, alcohol use disorder might have a more profound effect after gastric bypass surgery.

It had previously been shown that more than two-thirds of suicides happen within the first 3 years after bariatric surgery. With the initial weight loss comes renegotiation of personal relationships, and the potential for more mobility and perhaps expanded career choices; stress accompanies even positive changes in these major life domains. Some patients will also experience weight regain within the first 3 years, after an initial nadir. This also can cause deterioration in quality of life, the investigators explained.

Dr. Roberts and her coinvestigator acknowledge that some of the potential moderators may have been missed in the initial data reporting. For example, the “presurgical sample may be at higher risk for suicide or self-injury but withhold psychiatric history during evaluation for fear of being rejected for surgery.”

From an initial 2,676 studies identified for consideration, investigators in the end extracted data from 28 studies from the United States, Canada, Sweden, and Brazil. The studies had considerable heterogeneity in methods; some included presurgery/postsurgery analyses of the same patients, some had a comparator nonsurgical group, and some used a single postsurgical assessment.

In studies where no nonbariatric comparison sample was available, the investigators assigned interpolated comparison. To arrive at this measure, they drew on the World Health Organization–reported base rate of suicides in the study country at the approximate year of assessment. Suicide was the only interpolated outcome.

Various measures of suicide and self-harm were captured, including completed and probable suicides, suicide attempts, and self-harm events. In some studies, information was drawn from a suicide-specific questionnaire, or from a suicide item on another type of questionnaire.

There was significant variability in the odds ratios for suicide or self-harm across studies, Dr. Roberts said.

The researchers plan to continue analyzing additional measures captured in the meta-analysis, such as gender, age, initial body mass index, surgery type, and the percent of excess weight lost at the time of assessment for suicide or self-harm risk. They reported no outside sources of funding, and no conflicts of interest.
 

[email protected]

SOURCE: Roberts, D et al. Obesity Week 2018, Poster A433.

NASHVILLE – After bariatric surgery, individuals are at increased risk of suicide and self-harm, according to findings from a meta-analysis presented at the meeting.

Kari Oakes/MDedge News

Overall, the odds ratio was 1.69 for self-harm or suicide after bariatric surgery (95% confidence interval, 1.62-1.76; P less than .001), “indicating a nearly 70% increase in risk for self-harm or suicide following bariatric surgery,” wrote Dawn Roberts, PhD, of Bradley University, Peoria, Ill., and her coauthor, Nicole Pearl of Washington University, St. Louis, in the poster accompanying the presentation.

Further, as elapsed time from surgery grew, the suicide rate dropped (effect size covariance, r = –0.25). “Thus, the greatest risk for self-harm or suicide appears to emerge in the years immediately following surgery,” Dr. Roberts said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The investigators had a primary objective of characterizing the association between bariatric surgery and suicide or self-harm. The secondary purpose of the meta-analysis was to find moderators of the association that could explain some of the variability that had previously been seen in studies looking at mental health outcomes after bariatric surgery.

Some of the potential moderators, explained the investigators, included the surgery type. With Roux-en-Y gastric bypass (RYGB), more tissue is removed, potentially causing “more extensive disruption of neural pathways,” the investigators wrote. With greater loss of small-intestine surface area might come more disruption of the gut-brain axis, along with unknown effects on metabolism and pharmacokinetics of psychiatric medication. Additionally, alcohol use disorder might have a more profound effect after gastric bypass surgery.

It had previously been shown that more than two-thirds of suicides happen within the first 3 years after bariatric surgery. With the initial weight loss comes renegotiation of personal relationships, and the potential for more mobility and perhaps expanded career choices; stress accompanies even positive changes in these major life domains. Some patients will also experience weight regain within the first 3 years, after an initial nadir. This also can cause deterioration in quality of life, the investigators explained.

Dr. Roberts and her coinvestigator acknowledge that some of the potential moderators may have been missed in the initial data reporting. For example, the “presurgical sample may be at higher risk for suicide or self-injury but withhold psychiatric history during evaluation for fear of being rejected for surgery.”

From an initial 2,676 studies identified for consideration, investigators in the end extracted data from 28 studies from the United States, Canada, Sweden, and Brazil. The studies had considerable heterogeneity in methods; some included presurgery/postsurgery analyses of the same patients, some had a comparator nonsurgical group, and some used a single postsurgical assessment.

In studies where no nonbariatric comparison sample was available, the investigators assigned interpolated comparison. To arrive at this measure, they drew on the World Health Organization–reported base rate of suicides in the study country at the approximate year of assessment. Suicide was the only interpolated outcome.

Various measures of suicide and self-harm were captured, including completed and probable suicides, suicide attempts, and self-harm events. In some studies, information was drawn from a suicide-specific questionnaire, or from a suicide item on another type of questionnaire.

There was significant variability in the odds ratios for suicide or self-harm across studies, Dr. Roberts said.

The researchers plan to continue analyzing additional measures captured in the meta-analysis, such as gender, age, initial body mass index, surgery type, and the percent of excess weight lost at the time of assessment for suicide or self-harm risk. They reported no outside sources of funding, and no conflicts of interest.
 

[email protected]

SOURCE: Roberts, D et al. Obesity Week 2018, Poster A433.

NASHVILLE – After bariatric surgery, individuals are at increased risk of suicide and self-harm, according to findings from a meta-analysis presented at the meeting.

Kari Oakes/MDedge News

Overall, the odds ratio was 1.69 for self-harm or suicide after bariatric surgery (95% confidence interval, 1.62-1.76; P less than .001), “indicating a nearly 70% increase in risk for self-harm or suicide following bariatric surgery,” wrote Dawn Roberts, PhD, of Bradley University, Peoria, Ill., and her coauthor, Nicole Pearl of Washington University, St. Louis, in the poster accompanying the presentation.

Further, as elapsed time from surgery grew, the suicide rate dropped (effect size covariance, r = –0.25). “Thus, the greatest risk for self-harm or suicide appears to emerge in the years immediately following surgery,” Dr. Roberts said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The investigators had a primary objective of characterizing the association between bariatric surgery and suicide or self-harm. The secondary purpose of the meta-analysis was to find moderators of the association that could explain some of the variability that had previously been seen in studies looking at mental health outcomes after bariatric surgery.

Some of the potential moderators, explained the investigators, included the surgery type. With Roux-en-Y gastric bypass (RYGB), more tissue is removed, potentially causing “more extensive disruption of neural pathways,” the investigators wrote. With greater loss of small-intestine surface area might come more disruption of the gut-brain axis, along with unknown effects on metabolism and pharmacokinetics of psychiatric medication. Additionally, alcohol use disorder might have a more profound effect after gastric bypass surgery.

It had previously been shown that more than two-thirds of suicides happen within the first 3 years after bariatric surgery. With the initial weight loss comes renegotiation of personal relationships, and the potential for more mobility and perhaps expanded career choices; stress accompanies even positive changes in these major life domains. Some patients will also experience weight regain within the first 3 years, after an initial nadir. This also can cause deterioration in quality of life, the investigators explained.

Dr. Roberts and her coinvestigator acknowledge that some of the potential moderators may have been missed in the initial data reporting. For example, the “presurgical sample may be at higher risk for suicide or self-injury but withhold psychiatric history during evaluation for fear of being rejected for surgery.”

From an initial 2,676 studies identified for consideration, investigators in the end extracted data from 28 studies from the United States, Canada, Sweden, and Brazil. The studies had considerable heterogeneity in methods; some included presurgery/postsurgery analyses of the same patients, some had a comparator nonsurgical group, and some used a single postsurgical assessment.

In studies where no nonbariatric comparison sample was available, the investigators assigned interpolated comparison. To arrive at this measure, they drew on the World Health Organization–reported base rate of suicides in the study country at the approximate year of assessment. Suicide was the only interpolated outcome.

Various measures of suicide and self-harm were captured, including completed and probable suicides, suicide attempts, and self-harm events. In some studies, information was drawn from a suicide-specific questionnaire, or from a suicide item on another type of questionnaire.

There was significant variability in the odds ratios for suicide or self-harm across studies, Dr. Roberts said.

The researchers plan to continue analyzing additional measures captured in the meta-analysis, such as gender, age, initial body mass index, surgery type, and the percent of excess weight lost at the time of assessment for suicide or self-harm risk. They reported no outside sources of funding, and no conflicts of interest.
 

[email protected]

SOURCE: Roberts, D et al. Obesity Week 2018, Poster A433.

He tweets, he (doesn’t) score!

We all know that less sleep equals poor job performance. Up way too late on a Sunday night means you might fall face first into your keyboard the next morning and accidentally send an email that ends with “hhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhh.” So, yeah, sleep is important.

monkeybusinessimages/Thinkstock

It’s especially important when you are a professional athlete and your entire livelihood depends on you being in tip-top shape. Researchers from the State University of New York at Stony Brook studied the performance of NBA players in relation to their late-night Twitter binges. Unsurprisingly, tweeting in the wee hours correlated with fewer points and fewer rebounds in the next day’s game. We’re sure coaches are just thrilled to hear about their players spending precious night hours @-ing random trolls on Twitter. Does this mean less tweeting and more sleep means anyone can be the next LeBron? Or, um, the next @KingJames? Probably not … but give it a try.

Poppy seeds and probative pee

As you tuck into your Thanksgiving leftovers, give a thought to a valiant physician who ate and drank – and peed – for science. Not just once, but twice.

Fudio/Getty Images

At the recent Pain Care for Primary Care symposium in San Diego, Mount Sinai Beth Israel addiction specialist Edwin Salsitz, MD, gave a presentation about drug screening and mentioned his own homegrown investigation into two reputed sources of false positives.

A few years ago, a patient tested positive for opiates and, like many before him, blamed his fondness for poppy-seed bagels. Dr. Salsitz asked the patient to buy him a poppy bagel from his usual source, then the doctor went home and ate it on a Sunday prior to collecting his own pee. The doctor’s subsequent urine test was positive for opiates, and the patient was off the hook. (For more about the poppy-seed menace to accurate opiate testing, check this clinical update from the Aegis testing company.)

Later, it was time to check another possible urban legend. Dr. Salsitz got some mate de coca tea from a friend who’d returned from South America. Again, he took time out of a Sunday, this time to enjoy a hot beverage, mate de coca style, and collect his own pee. The urine test was positive this time, too – for cocaine.

The moral of the story? If you have a drug test looming, be safe and just stick to a croissant and coffee.

Psst … want a cookie?

In medical school, the best and brightest sacrifice their bodies and social lives to absorb knowledge like human sponges. Or maybe it’s where they absorb cookies in exchange for positive end-of-course evaluations.

Purestock/thinkstockphotos.com

Investigators from the University of Münster (Germany) decided to give 118 of the school’s third-year medical students a little test. During a course on emergency medicine, some groups were given access to free chocolate cookies (Discus deliciosum spp.) in their sessions, and some groups were not. When it came time to fill out their “student evaluations of teaching” at the end of the semester, the “cookie group” was more generous in its ratings of the course material and gave significantly higher scores to the teachers and to the course overall, compared with the control group (Med Educ. 2018 Oct;52[10]:1064-72).

This all seemed a little suspicious, so we did a little digging. Turns out that the cookie group – the one that provided all that warm, chocolatey positive reinforcement – was chock full of the usual suspects: Ernie the elf, Mrs. Fields, Famous Amos, and Mr. Big himself, Cookie Monster.

Why Myles Standish wasn’t fat

In the autumn of 1621, obesity didn’t dine with the 53 Pilgrims who gave culinary thanks for surviving their first disappointing Boston Bruins season. Er, for their first harvest after a brutal New England winter. Why was that first Thanksgiving such a svelte affair, free of the high-BMI epidemic that afflicts so many Bruins faithful nearly 4 centuries later? Was it the free-range turkey? The lean venison? The Wampanoag guests’ demands for a DASH-diet dinner?

Public domain

A modern study may help reveal the historical truth: 17th century Plymouth Plantation wasn’t yet bisected by the 21st century Cape Cod traffic snarling the Pilgrims Highway, a.k.a. Massachusetts Route 3.

It was Spanish researchers, not English Puritans, who unbuckled the portly puzzle’s Pilgrim hat. Investigators with the Barcelona Institute for Global Health examined the link between traffic noise exposure and obesity markers among a group of Swiss adults. The verdict? Those exposed to the highest levels of traffic noise ran the greatest risk of becoming obese. Specifically, every 10-decibel rise in road noise packed on another 17% increase in obesity. Seems tractor-trailer downshifts and honking horns may disturb sleep, gridlocking glucose metabolism and diverting everyone to the nearest drive-thru.

Next on the Spaniards’ research to-do list: Can your New England uncle’s annual Turkey Day tales of Red Sox triumphs trigger psychosis among familial Yankees fans?

He tweets, he (doesn’t) score!

We all know that less sleep equals poor job performance. Up way too late on a Sunday night means you might fall face first into your keyboard the next morning and accidentally send an email that ends with “hhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhh.” So, yeah, sleep is important.

monkeybusinessimages/Thinkstock

It’s especially important when you are a professional athlete and your entire livelihood depends on you being in tip-top shape. Researchers from the State University of New York at Stony Brook studied the performance of NBA players in relation to their late-night Twitter binges. Unsurprisingly, tweeting in the wee hours correlated with fewer points and fewer rebounds in the next day’s game. We’re sure coaches are just thrilled to hear about their players spending precious night hours @-ing random trolls on Twitter. Does this mean less tweeting and more sleep means anyone can be the next LeBron? Or, um, the next @KingJames? Probably not … but give it a try.

Poppy seeds and probative pee

As you tuck into your Thanksgiving leftovers, give a thought to a valiant physician who ate and drank – and peed – for science. Not just once, but twice.

Fudio/Getty Images

At the recent Pain Care for Primary Care symposium in San Diego, Mount Sinai Beth Israel addiction specialist Edwin Salsitz, MD, gave a presentation about drug screening and mentioned his own homegrown investigation into two reputed sources of false positives.

A few years ago, a patient tested positive for opiates and, like many before him, blamed his fondness for poppy-seed bagels. Dr. Salsitz asked the patient to buy him a poppy bagel from his usual source, then the doctor went home and ate it on a Sunday prior to collecting his own pee. The doctor’s subsequent urine test was positive for opiates, and the patient was off the hook. (For more about the poppy-seed menace to accurate opiate testing, check this clinical update from the Aegis testing company.)

Later, it was time to check another possible urban legend. Dr. Salsitz got some mate de coca tea from a friend who’d returned from South America. Again, he took time out of a Sunday, this time to enjoy a hot beverage, mate de coca style, and collect his own pee. The urine test was positive this time, too – for cocaine.

The moral of the story? If you have a drug test looming, be safe and just stick to a croissant and coffee.

Psst … want a cookie?

In medical school, the best and brightest sacrifice their bodies and social lives to absorb knowledge like human sponges. Or maybe it’s where they absorb cookies in exchange for positive end-of-course evaluations.

Purestock/thinkstockphotos.com

Investigators from the University of Münster (Germany) decided to give 118 of the school’s third-year medical students a little test. During a course on emergency medicine, some groups were given access to free chocolate cookies (Discus deliciosum spp.) in their sessions, and some groups were not. When it came time to fill out their “student evaluations of teaching” at the end of the semester, the “cookie group” was more generous in its ratings of the course material and gave significantly higher scores to the teachers and to the course overall, compared with the control group (Med Educ. 2018 Oct;52[10]:1064-72).

This all seemed a little suspicious, so we did a little digging. Turns out that the cookie group – the one that provided all that warm, chocolatey positive reinforcement – was chock full of the usual suspects: Ernie the elf, Mrs. Fields, Famous Amos, and Mr. Big himself, Cookie Monster.

Why Myles Standish wasn’t fat

In the autumn of 1621, obesity didn’t dine with the 53 Pilgrims who gave culinary thanks for surviving their first disappointing Boston Bruins season. Er, for their first harvest after a brutal New England winter. Why was that first Thanksgiving such a svelte affair, free of the high-BMI epidemic that afflicts so many Bruins faithful nearly 4 centuries later? Was it the free-range turkey? The lean venison? The Wampanoag guests’ demands for a DASH-diet dinner?

Public domain

A modern study may help reveal the historical truth: 17th century Plymouth Plantation wasn’t yet bisected by the 21st century Cape Cod traffic snarling the Pilgrims Highway, a.k.a. Massachusetts Route 3.

It was Spanish researchers, not English Puritans, who unbuckled the portly puzzle’s Pilgrim hat. Investigators with the Barcelona Institute for Global Health examined the link between traffic noise exposure and obesity markers among a group of Swiss adults. The verdict? Those exposed to the highest levels of traffic noise ran the greatest risk of becoming obese. Specifically, every 10-decibel rise in road noise packed on another 17% increase in obesity. Seems tractor-trailer downshifts and honking horns may disturb sleep, gridlocking glucose metabolism and diverting everyone to the nearest drive-thru.

Next on the Spaniards’ research to-do list: Can your New England uncle’s annual Turkey Day tales of Red Sox triumphs trigger psychosis among familial Yankees fans?

He tweets, he (doesn’t) score!

We all know that less sleep equals poor job performance. Up way too late on a Sunday night means you might fall face first into your keyboard the next morning and accidentally send an email that ends with “hhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhh.” So, yeah, sleep is important.

monkeybusinessimages/Thinkstock

It’s especially important when you are a professional athlete and your entire livelihood depends on you being in tip-top shape. Researchers from the State University of New York at Stony Brook studied the performance of NBA players in relation to their late-night Twitter binges. Unsurprisingly, tweeting in the wee hours correlated with fewer points and fewer rebounds in the next day’s game. We’re sure coaches are just thrilled to hear about their players spending precious night hours @-ing random trolls on Twitter. Does this mean less tweeting and more sleep means anyone can be the next LeBron? Or, um, the next @KingJames? Probably not … but give it a try.

Poppy seeds and probative pee

As you tuck into your Thanksgiving leftovers, give a thought to a valiant physician who ate and drank – and peed – for science. Not just once, but twice.

Fudio/Getty Images

At the recent Pain Care for Primary Care symposium in San Diego, Mount Sinai Beth Israel addiction specialist Edwin Salsitz, MD, gave a presentation about drug screening and mentioned his own homegrown investigation into two reputed sources of false positives.

A few years ago, a patient tested positive for opiates and, like many before him, blamed his fondness for poppy-seed bagels. Dr. Salsitz asked the patient to buy him a poppy bagel from his usual source, then the doctor went home and ate it on a Sunday prior to collecting his own pee. The doctor’s subsequent urine test was positive for opiates, and the patient was off the hook. (For more about the poppy-seed menace to accurate opiate testing, check this clinical update from the Aegis testing company.)

Later, it was time to check another possible urban legend. Dr. Salsitz got some mate de coca tea from a friend who’d returned from South America. Again, he took time out of a Sunday, this time to enjoy a hot beverage, mate de coca style, and collect his own pee. The urine test was positive this time, too – for cocaine.

The moral of the story? If you have a drug test looming, be safe and just stick to a croissant and coffee.

Psst … want a cookie?

In medical school, the best and brightest sacrifice their bodies and social lives to absorb knowledge like human sponges. Or maybe it’s where they absorb cookies in exchange for positive end-of-course evaluations.

Purestock/thinkstockphotos.com

Investigators from the University of Münster (Germany) decided to give 118 of the school’s third-year medical students a little test. During a course on emergency medicine, some groups were given access to free chocolate cookies (Discus deliciosum spp.) in their sessions, and some groups were not. When it came time to fill out their “student evaluations of teaching” at the end of the semester, the “cookie group” was more generous in its ratings of the course material and gave significantly higher scores to the teachers and to the course overall, compared with the control group (Med Educ. 2018 Oct;52[10]:1064-72).

This all seemed a little suspicious, so we did a little digging. Turns out that the cookie group – the one that provided all that warm, chocolatey positive reinforcement – was chock full of the usual suspects: Ernie the elf, Mrs. Fields, Famous Amos, and Mr. Big himself, Cookie Monster.

Why Myles Standish wasn’t fat

In the autumn of 1621, obesity didn’t dine with the 53 Pilgrims who gave culinary thanks for surviving their first disappointing Boston Bruins season. Er, for their first harvest after a brutal New England winter. Why was that first Thanksgiving such a svelte affair, free of the high-BMI epidemic that afflicts so many Bruins faithful nearly 4 centuries later? Was it the free-range turkey? The lean venison? The Wampanoag guests’ demands for a DASH-diet dinner?

Public domain

A modern study may help reveal the historical truth: 17th century Plymouth Plantation wasn’t yet bisected by the 21st century Cape Cod traffic snarling the Pilgrims Highway, a.k.a. Massachusetts Route 3.

It was Spanish researchers, not English Puritans, who unbuckled the portly puzzle’s Pilgrim hat. Investigators with the Barcelona Institute for Global Health examined the link between traffic noise exposure and obesity markers among a group of Swiss adults. The verdict? Those exposed to the highest levels of traffic noise ran the greatest risk of becoming obese. Specifically, every 10-decibel rise in road noise packed on another 17% increase in obesity. Seems tractor-trailer downshifts and honking horns may disturb sleep, gridlocking glucose metabolism and diverting everyone to the nearest drive-thru.

Next on the Spaniards’ research to-do list: Can your New England uncle’s annual Turkey Day tales of Red Sox triumphs trigger psychosis among familial Yankees fans?

Patients with multiple sclerosis (MS) who stop taking the MS medication Gilenya (fingolimod) may experience severe disease worsening, according to a safety announcement from the Food and Drug Administration. The disease may become worse than it was before patients started the medication or while patients were taking the drug. Severe worsening is rare but can result in permanent disability, according to the FDA statement.

[email protected]

Patients with multiple sclerosis (MS) who stop taking the MS medication Gilenya (fingolimod) may experience severe disease worsening, according to a safety announcement from the Food and Drug Administration. The disease may become worse than it was before patients started the medication or while patients were taking the drug. Severe worsening is rare but can result in permanent disability, according to the FDA statement.

[email protected]

Patients with multiple sclerosis (MS) who stop taking the MS medication Gilenya (fingolimod) may experience severe disease worsening, according to a safety announcement from the Food and Drug Administration. The disease may become worse than it was before patients started the medication or while patients were taking the drug. Severe worsening is rare but can result in permanent disability, according to the FDA statement.

[email protected]

Ibrutinib and checkpoint inhibitors may improve the efficacy of chimeric antigen receptor (CAR) T-cell therapies, according to investigators in two separate studies.

Meanwhile, responses to tisagenlecleucel appear to be even more durable with longer follow-up, according to preliminary results from two more CAR T-cell therapy studies slated for presentation at the annual meeting of the American Society of Hematology.

A fifth study will show that bone marrow transplant may effectively consolidate remission after CAR T-cell therapy, according to Robert A. Brodsky, MD, ASH secretary, who highlighted the studies during a media briefing.

The ibrutinib study (abstract 299) shows that administering this BTK inhibitor starting 2 weeks prior to leukapheresis and continuing until 3 months after JCAR014 could improve responses and may decrease the incidence of severe cytokine release syndrome in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Of 16 patients in an ibrutinib cohort and 18 patients in a no-ibrutinib cohort, the proportion of responders was 88% and 56%, respectively, according to preliminary data reported in the abstract. Grade 3-5 cytokine release syndrome occurred in 5 of 19 patients in the no-ibrutinib cohort, and 0 of 17 patients in the ibrutinib cohort.

Those findings are “early and preliminary, but very exciting” for ibrutinib in combination with this CD-19 specific CAR T-cell therapy said Dr. Brodsky, director of the division of hematology at Johns Hopkins University in Baltimore.

Early results of the checkpoint inhibitor study (abstract 556) suggest that pembrolizumab or nivolumab may augment CD19-directed CAR T-cell therapy in patients with relapsed B-cell acute lymphoblastic leukemia (ALL).

In data to date, 14 patients with early CAR T-cell loss, partial response, or no response to CAR T-cell therapy received a PD-1 inhibitor.

“The idea was if you can give pembrolizumab, you can take the brakes off, and maybe you can reinitiate the immune attack,” Dr. Brodsky said. “Sure enough, they were able to see that in roughly half of the patients. So again, very small, preliminary data, but very exciting that it is safe to give checkpoint inhibitors with CAR T-cells and it may be efficacious at getting the immune response back.”

One of the two tisagenlecleucel updates (abstract 895) showed that in the ELIANA trial, which included pediatric and young adults patients with relapsed/refractory ALL, the probability of relapse-free survival at 18 months was 66%.

“These are some very fast-growing tumors and these are refractory resistant patients, so as we get further and further out, it’s more encouraging to see that there are durable responses,” Dr. Brodsky said.

In the other tisagenlecleucel update (abstract 1684), investigators showed sustained disease control in Juliet, the global trial including adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with 40% of patients still in remission at 18 months, according to Dr. Brodsky.

One more report Dr. Brodsky highlighted (abstract 967) will look at long-term follow-up after administration of SCRI-CAR19v1, a CD19-specific CAR T-cell product. Preliminary data suggest a survival advantage when hematopoietic stem cell transplantation is done after CAR T-cell induced remission.

“This study is very small and it’s retrospective, but it suggests that bone marrow transplant is a good way to consolidate the remission after CAR T-cell therapy,” Dr. Brodsky said.

Ibrutinib and checkpoint inhibitors may improve the efficacy of chimeric antigen receptor (CAR) T-cell therapies, according to investigators in two separate studies.

Meanwhile, responses to tisagenlecleucel appear to be even more durable with longer follow-up, according to preliminary results from two more CAR T-cell therapy studies slated for presentation at the annual meeting of the American Society of Hematology.

A fifth study will show that bone marrow transplant may effectively consolidate remission after CAR T-cell therapy, according to Robert A. Brodsky, MD, ASH secretary, who highlighted the studies during a media briefing.

The ibrutinib study (abstract 299) shows that administering this BTK inhibitor starting 2 weeks prior to leukapheresis and continuing until 3 months after JCAR014 could improve responses and may decrease the incidence of severe cytokine release syndrome in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Of 16 patients in an ibrutinib cohort and 18 patients in a no-ibrutinib cohort, the proportion of responders was 88% and 56%, respectively, according to preliminary data reported in the abstract. Grade 3-5 cytokine release syndrome occurred in 5 of 19 patients in the no-ibrutinib cohort, and 0 of 17 patients in the ibrutinib cohort.

Those findings are “early and preliminary, but very exciting” for ibrutinib in combination with this CD-19 specific CAR T-cell therapy said Dr. Brodsky, director of the division of hematology at Johns Hopkins University in Baltimore.

Early results of the checkpoint inhibitor study (abstract 556) suggest that pembrolizumab or nivolumab may augment CD19-directed CAR T-cell therapy in patients with relapsed B-cell acute lymphoblastic leukemia (ALL).

In data to date, 14 patients with early CAR T-cell loss, partial response, or no response to CAR T-cell therapy received a PD-1 inhibitor.

“The idea was if you can give pembrolizumab, you can take the brakes off, and maybe you can reinitiate the immune attack,” Dr. Brodsky said. “Sure enough, they were able to see that in roughly half of the patients. So again, very small, preliminary data, but very exciting that it is safe to give checkpoint inhibitors with CAR T-cells and it may be efficacious at getting the immune response back.”

One of the two tisagenlecleucel updates (abstract 895) showed that in the ELIANA trial, which included pediatric and young adults patients with relapsed/refractory ALL, the probability of relapse-free survival at 18 months was 66%.

“These are some very fast-growing tumors and these are refractory resistant patients, so as we get further and further out, it’s more encouraging to see that there are durable responses,” Dr. Brodsky said.

In the other tisagenlecleucel update (abstract 1684), investigators showed sustained disease control in Juliet, the global trial including adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with 40% of patients still in remission at 18 months, according to Dr. Brodsky.

One more report Dr. Brodsky highlighted (abstract 967) will look at long-term follow-up after administration of SCRI-CAR19v1, a CD19-specific CAR T-cell product. Preliminary data suggest a survival advantage when hematopoietic stem cell transplantation is done after CAR T-cell induced remission.

“This study is very small and it’s retrospective, but it suggests that bone marrow transplant is a good way to consolidate the remission after CAR T-cell therapy,” Dr. Brodsky said.

Ibrutinib and checkpoint inhibitors may improve the efficacy of chimeric antigen receptor (CAR) T-cell therapies, according to investigators in two separate studies.

Meanwhile, responses to tisagenlecleucel appear to be even more durable with longer follow-up, according to preliminary results from two more CAR T-cell therapy studies slated for presentation at the annual meeting of the American Society of Hematology.

A fifth study will show that bone marrow transplant may effectively consolidate remission after CAR T-cell therapy, according to Robert A. Brodsky, MD, ASH secretary, who highlighted the studies during a media briefing.

The ibrutinib study (abstract 299) shows that administering this BTK inhibitor starting 2 weeks prior to leukapheresis and continuing until 3 months after JCAR014 could improve responses and may decrease the incidence of severe cytokine release syndrome in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Of 16 patients in an ibrutinib cohort and 18 patients in a no-ibrutinib cohort, the proportion of responders was 88% and 56%, respectively, according to preliminary data reported in the abstract. Grade 3-5 cytokine release syndrome occurred in 5 of 19 patients in the no-ibrutinib cohort, and 0 of 17 patients in the ibrutinib cohort.

Those findings are “early and preliminary, but very exciting” for ibrutinib in combination with this CD-19 specific CAR T-cell therapy said Dr. Brodsky, director of the division of hematology at Johns Hopkins University in Baltimore.

Early results of the checkpoint inhibitor study (abstract 556) suggest that pembrolizumab or nivolumab may augment CD19-directed CAR T-cell therapy in patients with relapsed B-cell acute lymphoblastic leukemia (ALL).

In data to date, 14 patients with early CAR T-cell loss, partial response, or no response to CAR T-cell therapy received a PD-1 inhibitor.

“The idea was if you can give pembrolizumab, you can take the brakes off, and maybe you can reinitiate the immune attack,” Dr. Brodsky said. “Sure enough, they were able to see that in roughly half of the patients. So again, very small, preliminary data, but very exciting that it is safe to give checkpoint inhibitors with CAR T-cells and it may be efficacious at getting the immune response back.”

One of the two tisagenlecleucel updates (abstract 895) showed that in the ELIANA trial, which included pediatric and young adults patients with relapsed/refractory ALL, the probability of relapse-free survival at 18 months was 66%.

“These are some very fast-growing tumors and these are refractory resistant patients, so as we get further and further out, it’s more encouraging to see that there are durable responses,” Dr. Brodsky said.

In the other tisagenlecleucel update (abstract 1684), investigators showed sustained disease control in Juliet, the global trial including adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with 40% of patients still in remission at 18 months, according to Dr. Brodsky.

One more report Dr. Brodsky highlighted (abstract 967) will look at long-term follow-up after administration of SCRI-CAR19v1, a CD19-specific CAR T-cell product. Preliminary data suggest a survival advantage when hematopoietic stem cell transplantation is done after CAR T-cell induced remission.

“This study is very small and it’s retrospective, but it suggests that bone marrow transplant is a good way to consolidate the remission after CAR T-cell therapy,” Dr. Brodsky said.

Sickle cell disease will take center stage at the annual meeting of the American Society of Hematology.

Top studies to be featured at ASH 2018 include the first in-human presentation of a new approach to gene therapy in sickle cell disease, long-term outcomes of haploidentical transplants, mortality rates in patients prescribed opioids, and aspects of care in lower-resource countries, according to Alexis A. Thompson, MD, the current ASH president.

“These are all quite different aspects of work being done,” said Dr. Thompson, associate director of equity and minority health at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago.

In the gene therapy study (abstract 1023), investigators will report initial results of genetic targeting of the fetal-to-adult globin switch in sickle cell patients. The clinical pilot study involves autologous gene therapy utilizing microRNA-adapted shRNAs (shRNA^miR) lentiviral vector targeting BCL11A, a repressor of gamma globin expression, according to the investigators.

“We’re looking forward to seeing this initial presentation on their findings with this first administration to humans,” Dr. Thompson said in a media briefing.

In another study (abstract 162), investigators will report long-term results of familial haploidentical stem cell transplantation (HISCT) showing that high-risk sickle cell patients had significantly improved health-related quality of life in long-term follow-up.

Two years after myeloablative conditioning and familial HISCT using CD34 enrichment and mononuclear cell (CD3) addback, recipients had significant improvements in emotional and physical health-related quality of life, among other outcomes of interest, including neurocognitive outcomes.

Another study, which is interesting in the context of the national opioid epidemic, Dr. Thompson said, will show that opioid use was not associated with in-hospital mortality in patients with sickle cell disease (abstract 315).

Looking at data from the National Inpatient Sample, there was no increase in in-hospital mortality in sickle cell patients versus the general population since the onset of the epidemic, which has been documented since 2000, according to the investigators.

“It should alleviate many concerns about patients with sickle cell who, for legitimate reasons, may require high doses of opioids,” Dr. Thompson said. “While I think we’re being very mindful about opioid use in this patient population, they certainly do need these high doses, but there does not seem to be an extraordinary risk of death associated with their use.”

One final study worth watching, according to Dr. Thompson, is REACH, a prospective, multinational trial of hydroxyurea for sickle cell anemia in sub-Saharan Africa (abstract 3).

The study, which included 635 children, provides the first prospective data showing the feasibility, safety, and benefits of hydroxyurea treatment for children with sickle cell anemia in sub-Saharan Africa, according to the investigators.

The findings are “quite encouraging,” said Dr. Thompson, adding that the results looked “very similar” to the United States experience and demonstrated effective clinical trial design and execution in a lower-resource country.

Sickle cell disease will take center stage at the annual meeting of the American Society of Hematology.

Top studies to be featured at ASH 2018 include the first in-human presentation of a new approach to gene therapy in sickle cell disease, long-term outcomes of haploidentical transplants, mortality rates in patients prescribed opioids, and aspects of care in lower-resource countries, according to Alexis A. Thompson, MD, the current ASH president.

“These are all quite different aspects of work being done,” said Dr. Thompson, associate director of equity and minority health at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago.

In the gene therapy study (abstract 1023), investigators will report initial results of genetic targeting of the fetal-to-adult globin switch in sickle cell patients. The clinical pilot study involves autologous gene therapy utilizing microRNA-adapted shRNAs (shRNA^miR) lentiviral vector targeting BCL11A, a repressor of gamma globin expression, according to the investigators.

“We’re looking forward to seeing this initial presentation on their findings with this first administration to humans,” Dr. Thompson said in a media briefing.

In another study (abstract 162), investigators will report long-term results of familial haploidentical stem cell transplantation (HISCT) showing that high-risk sickle cell patients had significantly improved health-related quality of life in long-term follow-up.

Two years after myeloablative conditioning and familial HISCT using CD34 enrichment and mononuclear cell (CD3) addback, recipients had significant improvements in emotional and physical health-related quality of life, among other outcomes of interest, including neurocognitive outcomes.

Another study, which is interesting in the context of the national opioid epidemic, Dr. Thompson said, will show that opioid use was not associated with in-hospital mortality in patients with sickle cell disease (abstract 315).

Looking at data from the National Inpatient Sample, there was no increase in in-hospital mortality in sickle cell patients versus the general population since the onset of the epidemic, which has been documented since 2000, according to the investigators.

“It should alleviate many concerns about patients with sickle cell who, for legitimate reasons, may require high doses of opioids,” Dr. Thompson said. “While I think we’re being very mindful about opioid use in this patient population, they certainly do need these high doses, but there does not seem to be an extraordinary risk of death associated with their use.”

One final study worth watching, according to Dr. Thompson, is REACH, a prospective, multinational trial of hydroxyurea for sickle cell anemia in sub-Saharan Africa (abstract 3).

The study, which included 635 children, provides the first prospective data showing the feasibility, safety, and benefits of hydroxyurea treatment for children with sickle cell anemia in sub-Saharan Africa, according to the investigators.

The findings are “quite encouraging,” said Dr. Thompson, adding that the results looked “very similar” to the United States experience and demonstrated effective clinical trial design and execution in a lower-resource country.

Sickle cell disease will take center stage at the annual meeting of the American Society of Hematology.

Top studies to be featured at ASH 2018 include the first in-human presentation of a new approach to gene therapy in sickle cell disease, long-term outcomes of haploidentical transplants, mortality rates in patients prescribed opioids, and aspects of care in lower-resource countries, according to Alexis A. Thompson, MD, the current ASH president.

“These are all quite different aspects of work being done,” said Dr. Thompson, associate director of equity and minority health at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago.

In the gene therapy study (abstract 1023), investigators will report initial results of genetic targeting of the fetal-to-adult globin switch in sickle cell patients. The clinical pilot study involves autologous gene therapy utilizing microRNA-adapted shRNAs (shRNA^miR) lentiviral vector targeting BCL11A, a repressor of gamma globin expression, according to the investigators.

“We’re looking forward to seeing this initial presentation on their findings with this first administration to humans,” Dr. Thompson said in a media briefing.

In another study (abstract 162), investigators will report long-term results of familial haploidentical stem cell transplantation (HISCT) showing that high-risk sickle cell patients had significantly improved health-related quality of life in long-term follow-up.

Two years after myeloablative conditioning and familial HISCT using CD34 enrichment and mononuclear cell (CD3) addback, recipients had significant improvements in emotional and physical health-related quality of life, among other outcomes of interest, including neurocognitive outcomes.

Another study, which is interesting in the context of the national opioid epidemic, Dr. Thompson said, will show that opioid use was not associated with in-hospital mortality in patients with sickle cell disease (abstract 315).

Looking at data from the National Inpatient Sample, there was no increase in in-hospital mortality in sickle cell patients versus the general population since the onset of the epidemic, which has been documented since 2000, according to the investigators.

“It should alleviate many concerns about patients with sickle cell who, for legitimate reasons, may require high doses of opioids,” Dr. Thompson said. “While I think we’re being very mindful about opioid use in this patient population, they certainly do need these high doses, but there does not seem to be an extraordinary risk of death associated with their use.”

One final study worth watching, according to Dr. Thompson, is REACH, a prospective, multinational trial of hydroxyurea for sickle cell anemia in sub-Saharan Africa (abstract 3).

The study, which included 635 children, provides the first prospective data showing the feasibility, safety, and benefits of hydroxyurea treatment for children with sickle cell anemia in sub-Saharan Africa, according to the investigators.

The findings are “quite encouraging,” said Dr. Thompson, adding that the results looked “very similar” to the United States experience and demonstrated effective clinical trial design and execution in a lower-resource country.

CHICAGO – Failure to reach the therapeutic target of a serum urate level below 6 mg/dL in gout patients is an independent risk factor for all-cause mortality conferring a 139% increased risk, Fernando Perez-Ruiz, MD, PhD, said at the annual meeting of the American College of Rheumatology.

This new finding from a prospective cohort study of 1,193 gout patients constitutes a ringing endorsement that a treat-to-target approach should become the standard in the management of this disease, declared Dr. Perez-Ruiz, a rheumatologist at Hospital Universitario Cruces, Barakaldo, Spain.

“This is encouraging news. We can say to patients and clinicians that we should make every effort to reach the therapeutic target. This is a concept that’s not new in medicine. We do it for diabetes, for hypertension, for hyperlipidemia, and I think now for the first time we will do it for gout,” the rheumatologist said at a press conference highlighting the study findings.

“A lot of physicians including, unfortunately, rheumatologists don’t treat gout to target. They feel like if a patient is doing nicely, that’s good enough. But it’s like lowering cholesterol: If you’re at 400 mg/dL and you go to 300, does that mean it’s fine and you won’t get a myocardial infarction?” he asked rhetorically.

The study included 1,193 gout patients with a mean age at baseline of 60 years, 6.8 years disease duration, and an average of 3-4 flares during the previous year. Mean follow-up was 48 months, translating to 4,830 patient-years of prospective observation. Overall mortality was 13%, mostly from cardiovascular causes.

The mean baseline serum urate level was 9.1 mg/dL. Although both ACR and EULAR guidelines recommend a serum urate level below 6 mg/dL as a therapeutic target, 16.3% of subjects had a level of 6 mg/dL or more despite treatment. The crude mortality rate during follow-up was 80.9 deaths per 1,000 person-years in those with serum urate levels of 6 mg/dL or more, compared with 25.7 per 1,000 person-years in patients with serum urate levels below 6 mg/dL. In a multivariate analysis adjusted for age, prior cardiovascular events, other comorbid conditions, sex, baseline serum urate level, alcohol intake, and other potential confounders, a serum urate of 6 mg/dL or more was independently associated with a 139% increased risk of mortality during follow-up.

“I think the message we would like to give to clinicians is, ‘If you can do that [i.e., maintain the serum urate level below 6 mg/dL], do it. You have the knowledge, you have the means, make the effort. Your patient will benefit from that. Don’t take risks,’” Dr. Perez-Ruiz said.

Session moderator Shraddha Jatwani, MD, a rheumatologist at St. Vincent Hospital in Evansville, Ind., pronounced this a message she will take home to her clinical practice.

“What we usually see in clinical practice is that gout patients are among the most noncompliant. Once they stop hurting they just don’t see the need to take their medication daily. And now that we have this data, we can tell them that their gout medications are like statins, which help reduce the risk of heart attacks. Taking their gout medication will help them reduce their mortality risk. This information will help us to change patient perception,” she said.

Dr. Perez-Ruiz reported relationships with Amgen, Grünenthal, and Menarini.

[email protected]

SOURCE: Perez-Ruiz F et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 869.

CHICAGO – Failure to reach the therapeutic target of a serum urate level below 6 mg/dL in gout patients is an independent risk factor for all-cause mortality conferring a 139% increased risk, Fernando Perez-Ruiz, MD, PhD, said at the annual meeting of the American College of Rheumatology.

This new finding from a prospective cohort study of 1,193 gout patients constitutes a ringing endorsement that a treat-to-target approach should become the standard in the management of this disease, declared Dr. Perez-Ruiz, a rheumatologist at Hospital Universitario Cruces, Barakaldo, Spain.

“This is encouraging news. We can say to patients and clinicians that we should make every effort to reach the therapeutic target. This is a concept that’s not new in medicine. We do it for diabetes, for hypertension, for hyperlipidemia, and I think now for the first time we will do it for gout,” the rheumatologist said at a press conference highlighting the study findings.

“A lot of physicians including, unfortunately, rheumatologists don’t treat gout to target. They feel like if a patient is doing nicely, that’s good enough. But it’s like lowering cholesterol: If you’re at 400 mg/dL and you go to 300, does that mean it’s fine and you won’t get a myocardial infarction?” he asked rhetorically.

The study included 1,193 gout patients with a mean age at baseline of 60 years, 6.8 years disease duration, and an average of 3-4 flares during the previous year. Mean follow-up was 48 months, translating to 4,830 patient-years of prospective observation. Overall mortality was 13%, mostly from cardiovascular causes.

The mean baseline serum urate level was 9.1 mg/dL. Although both ACR and EULAR guidelines recommend a serum urate level below 6 mg/dL as a therapeutic target, 16.3% of subjects had a level of 6 mg/dL or more despite treatment. The crude mortality rate during follow-up was 80.9 deaths per 1,000 person-years in those with serum urate levels of 6 mg/dL or more, compared with 25.7 per 1,000 person-years in patients with serum urate levels below 6 mg/dL. In a multivariate analysis adjusted for age, prior cardiovascular events, other comorbid conditions, sex, baseline serum urate level, alcohol intake, and other potential confounders, a serum urate of 6 mg/dL or more was independently associated with a 139% increased risk of mortality during follow-up.

“I think the message we would like to give to clinicians is, ‘If you can do that [i.e., maintain the serum urate level below 6 mg/dL], do it. You have the knowledge, you have the means, make the effort. Your patient will benefit from that. Don’t take risks,’” Dr. Perez-Ruiz said.

Session moderator Shraddha Jatwani, MD, a rheumatologist at St. Vincent Hospital in Evansville, Ind., pronounced this a message she will take home to her clinical practice.

“What we usually see in clinical practice is that gout patients are among the most noncompliant. Once they stop hurting they just don’t see the need to take their medication daily. And now that we have this data, we can tell them that their gout medications are like statins, which help reduce the risk of heart attacks. Taking their gout medication will help them reduce their mortality risk. This information will help us to change patient perception,” she said.

Dr. Perez-Ruiz reported relationships with Amgen, Grünenthal, and Menarini.

[email protected]

SOURCE: Perez-Ruiz F et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 869.

CHICAGO – Failure to reach the therapeutic target of a serum urate level below 6 mg/dL in gout patients is an independent risk factor for all-cause mortality conferring a 139% increased risk, Fernando Perez-Ruiz, MD, PhD, said at the annual meeting of the American College of Rheumatology.

This new finding from a prospective cohort study of 1,193 gout patients constitutes a ringing endorsement that a treat-to-target approach should become the standard in the management of this disease, declared Dr. Perez-Ruiz, a rheumatologist at Hospital Universitario Cruces, Barakaldo, Spain.

“This is encouraging news. We can say to patients and clinicians that we should make every effort to reach the therapeutic target. This is a concept that’s not new in medicine. We do it for diabetes, for hypertension, for hyperlipidemia, and I think now for the first time we will do it for gout,” the rheumatologist said at a press conference highlighting the study findings.

“A lot of physicians including, unfortunately, rheumatologists don’t treat gout to target. They feel like if a patient is doing nicely, that’s good enough. But it’s like lowering cholesterol: If you’re at 400 mg/dL and you go to 300, does that mean it’s fine and you won’t get a myocardial infarction?” he asked rhetorically.

The study included 1,193 gout patients with a mean age at baseline of 60 years, 6.8 years disease duration, and an average of 3-4 flares during the previous year. Mean follow-up was 48 months, translating to 4,830 patient-years of prospective observation. Overall mortality was 13%, mostly from cardiovascular causes.

The mean baseline serum urate level was 9.1 mg/dL. Although both ACR and EULAR guidelines recommend a serum urate level below 6 mg/dL as a therapeutic target, 16.3% of subjects had a level of 6 mg/dL or more despite treatment. The crude mortality rate during follow-up was 80.9 deaths per 1,000 person-years in those with serum urate levels of 6 mg/dL or more, compared with 25.7 per 1,000 person-years in patients with serum urate levels below 6 mg/dL. In a multivariate analysis adjusted for age, prior cardiovascular events, other comorbid conditions, sex, baseline serum urate level, alcohol intake, and other potential confounders, a serum urate of 6 mg/dL or more was independently associated with a 139% increased risk of mortality during follow-up.

“I think the message we would like to give to clinicians is, ‘If you can do that [i.e., maintain the serum urate level below 6 mg/dL], do it. You have the knowledge, you have the means, make the effort. Your patient will benefit from that. Don’t take risks,’” Dr. Perez-Ruiz said.

Session moderator Shraddha Jatwani, MD, a rheumatologist at St. Vincent Hospital in Evansville, Ind., pronounced this a message she will take home to her clinical practice.

“What we usually see in clinical practice is that gout patients are among the most noncompliant. Once they stop hurting they just don’t see the need to take their medication daily. And now that we have this data, we can tell them that their gout medications are like statins, which help reduce the risk of heart attacks. Taking their gout medication will help them reduce their mortality risk. This information will help us to change patient perception,” she said.

Dr. Perez-Ruiz reported relationships with Amgen, Grünenthal, and Menarini.

[email protected]

SOURCE: Perez-Ruiz F et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 869.