Ticagrelor tablets

Photo courtesy of AstraZeneca

The American College of Cardiology (ACC) and American Heart Association (AHA) have released updated guidelines for the use of dual antiplatelet therapy (DAPT) in patients with coronary artery disease.

DAPT, the combination of aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), is used to reduce the risks of future heart attack and coronary stent thrombosis in this patient population.

Overall, the new guidelines, which update recommendations from 6 previous guidelines, recommend an individualized approach to DAPT.

The guidelines were published in the Journal of the American College of Cardiology.

The new recommendations are based on the current use of coronary stents that present a lower risk of thrombosis than some older stents.

The recommendations are also based on the findings of recent studies investigating the duration of DAPT in patients with coronary artery disease, specifically those with myocardial infarction and those undergoing coronary stent implantation.

Studies examining shorter duration (3 to 6 months) of DAPT compared with a standard 12 months of DAPT in select, generally lower-risk patients did not show an increased risk of stent thrombosis. And, in some cases, a shorter treatment duration was associated with less bleeding.

Other studies investigating extending DAPT for an additional 18 or 36 months (beyond a year) showed a decrease in the risk of heart attack and stent thrombosis at the expense of an increase in bleeding risk.

Overview of recommendations

In general, the recommendations regarding DAPT duration consist of a Class I recommendation of “should be given” for a minimum period of time (usually 6 to 12 months), and a Class IIb recommendation of “may be considered” for continuation beyond that time.

Shorter duration of DAPT is recommended for patients at lower ischemic risk with high bleeding risk, whereas longer duration of DAPT may be reasonable for patients at higher ischemic risk with lower bleeding risk.

These recommendations for duration of DAPT apply to newer-generation stents and, in general, only to those not treated with oral anticoagulant therapy.

An aspirin dose of 81 mg daily (range, 75-100 mg) is now recommended in patients treated with DAPT. Regardless of the duration of DAPT, aspirin is almost always continued indefinitely in patients with coronary artery disease.

The updated guidelines also address DAPT after coronary artery bypass grafting and issues regarding the timing of non-cardiac surgery in patients treated with coronary stent implantation and DAPT.

Decisions about the timing of surgery and whether to discontinue DAPT after coronary stent implantation involve weighing the particular surgical procedure and the risks of delaying the procedure, the risks of ischemia and stent thrombosis, and the risk and consequences of bleeding, and are therefore best individualized, according to the guidelines.

The new guidelines update recommendations on the duration of DAPT across 6 previously published guidelines:

• The 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention
• The 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery
• The 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease
• The 2013 ACC/AHA Guideline for the Management of ST-Elevation Myocardial Infarction
• The 2014 ACC/AHA Guideline for Non-ST-Elevation Acute Coronary Syndromes
• The 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery.
  

Ticagrelor tablets

Photo courtesy of AstraZeneca

The American College of Cardiology (ACC) and American Heart Association (AHA) have released updated guidelines for the use of dual antiplatelet therapy (DAPT) in patients with coronary artery disease.

DAPT, the combination of aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), is used to reduce the risks of future heart attack and coronary stent thrombosis in this patient population.

Overall, the new guidelines, which update recommendations from 6 previous guidelines, recommend an individualized approach to DAPT.

The guidelines were published in the Journal of the American College of Cardiology.

The new recommendations are based on the current use of coronary stents that present a lower risk of thrombosis than some older stents.

The recommendations are also based on the findings of recent studies investigating the duration of DAPT in patients with coronary artery disease, specifically those with myocardial infarction and those undergoing coronary stent implantation.

Studies examining shorter duration (3 to 6 months) of DAPT compared with a standard 12 months of DAPT in select, generally lower-risk patients did not show an increased risk of stent thrombosis. And, in some cases, a shorter treatment duration was associated with less bleeding.

Other studies investigating extending DAPT for an additional 18 or 36 months (beyond a year) showed a decrease in the risk of heart attack and stent thrombosis at the expense of an increase in bleeding risk.

Overview of recommendations

In general, the recommendations regarding DAPT duration consist of a Class I recommendation of “should be given” for a minimum period of time (usually 6 to 12 months), and a Class IIb recommendation of “may be considered” for continuation beyond that time.

Shorter duration of DAPT is recommended for patients at lower ischemic risk with high bleeding risk, whereas longer duration of DAPT may be reasonable for patients at higher ischemic risk with lower bleeding risk.

These recommendations for duration of DAPT apply to newer-generation stents and, in general, only to those not treated with oral anticoagulant therapy.

An aspirin dose of 81 mg daily (range, 75-100 mg) is now recommended in patients treated with DAPT. Regardless of the duration of DAPT, aspirin is almost always continued indefinitely in patients with coronary artery disease.

The updated guidelines also address DAPT after coronary artery bypass grafting and issues regarding the timing of non-cardiac surgery in patients treated with coronary stent implantation and DAPT.

Decisions about the timing of surgery and whether to discontinue DAPT after coronary stent implantation involve weighing the particular surgical procedure and the risks of delaying the procedure, the risks of ischemia and stent thrombosis, and the risk and consequences of bleeding, and are therefore best individualized, according to the guidelines.

The new guidelines update recommendations on the duration of DAPT across 6 previously published guidelines:

• The 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention
• The 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery
• The 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease
• The 2013 ACC/AHA Guideline for the Management of ST-Elevation Myocardial Infarction
• The 2014 ACC/AHA Guideline for Non-ST-Elevation Acute Coronary Syndromes
• The 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery.
  

Ticagrelor tablets

Photo courtesy of AstraZeneca

The American College of Cardiology (ACC) and American Heart Association (AHA) have released updated guidelines for the use of dual antiplatelet therapy (DAPT) in patients with coronary artery disease.

DAPT, the combination of aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), is used to reduce the risks of future heart attack and coronary stent thrombosis in this patient population.

Overall, the new guidelines, which update recommendations from 6 previous guidelines, recommend an individualized approach to DAPT.

The guidelines were published in the Journal of the American College of Cardiology.

The new recommendations are based on the current use of coronary stents that present a lower risk of thrombosis than some older stents.

The recommendations are also based on the findings of recent studies investigating the duration of DAPT in patients with coronary artery disease, specifically those with myocardial infarction and those undergoing coronary stent implantation.

Studies examining shorter duration (3 to 6 months) of DAPT compared with a standard 12 months of DAPT in select, generally lower-risk patients did not show an increased risk of stent thrombosis. And, in some cases, a shorter treatment duration was associated with less bleeding.

Other studies investigating extending DAPT for an additional 18 or 36 months (beyond a year) showed a decrease in the risk of heart attack and stent thrombosis at the expense of an increase in bleeding risk.

Overview of recommendations

In general, the recommendations regarding DAPT duration consist of a Class I recommendation of “should be given” for a minimum period of time (usually 6 to 12 months), and a Class IIb recommendation of “may be considered” for continuation beyond that time.

Shorter duration of DAPT is recommended for patients at lower ischemic risk with high bleeding risk, whereas longer duration of DAPT may be reasonable for patients at higher ischemic risk with lower bleeding risk.

These recommendations for duration of DAPT apply to newer-generation stents and, in general, only to those not treated with oral anticoagulant therapy.

An aspirin dose of 81 mg daily (range, 75-100 mg) is now recommended in patients treated with DAPT. Regardless of the duration of DAPT, aspirin is almost always continued indefinitely in patients with coronary artery disease.

The updated guidelines also address DAPT after coronary artery bypass grafting and issues regarding the timing of non-cardiac surgery in patients treated with coronary stent implantation and DAPT.

Decisions about the timing of surgery and whether to discontinue DAPT after coronary stent implantation involve weighing the particular surgical procedure and the risks of delaying the procedure, the risks of ischemia and stent thrombosis, and the risk and consequences of bleeding, and are therefore best individualized, according to the guidelines.

The new guidelines update recommendations on the duration of DAPT across 6 previously published guidelines:

• The 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention
• The 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery
• The 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease
• The 2013 ACC/AHA Guideline for the Management of ST-Elevation Myocardial Infarction
• The 2014 ACC/AHA Guideline for Non-ST-Elevation Acute Coronary Syndromes
• The 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery.
  

HSCT preparation

Photo by Chad McNeeley

The US Food and Drug Administration (FDA) has approved the use of defibrotide sodium (Defitelio).

The product can now be used to treat adult and pediatric patients who develop hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction after receiving a hematopoietic stem cell transplant (HSCT).

Defibrotide sodium is the first FDA-approved therapy for patients with this rare, potentially fatal complication.

Defibrotide sodium is a product of Jazz Pharmaceuticals, Inc. The company said shipments of the drug to distribution channels will begin within a week.

The recommended dose and schedule for defibrotide sodium is 6.25 mg/kg every 6 hours, given as a 2-hour intravenous infusion, for at least 21 days, and continued until VOD resolution or up to 60 days of treatment.

In vitro defibrotide sodium has profibrinolytic activity. The use of defibrotide sodium is contraindicated in patients receiving concurrent anticoagulants or fibrinolytic therapies. Hemorrhage and hypersensitivity reactions are the major potential adverse reactions.

The FDA previously granted the defibrotide sodium application priority review status, and the drug received orphan drug designation from the FDA for the treatment of hepatic VOD.

Full prescribing information for defibrotide sodium can be found on the FDA website.

Trial results

The FDA’s approval of defibrotide sodium is supported by data in 528 patients treated on 3 studies: a phase 2 trial, a phase 3 trial, and an expanded access study. Data from the expanded access study were presented at the 2015 BMT Tandem Meetings, and data from the phase 3 trial were published in Blood earlier this year.

The 528 patients all had hepatic VOD with multi-organ dysfunction after HSCT. They received defibrotide sodium at 6.25 mg/kg intravenously every 6 hours until resolution of VOD.

The approval was based on survival at day +100 after HSCT. The day +100 survival rates for Study 1 (phase 3, n=102), Study 2 (phase 2, n=75), and Study 3 (expanded access, n=351) were 38%, 44%, and 45%, respectively.

Based on published reports and analyses of patient-level data, the day +100 survival rates were 21% to 31% for patients with hepatic VOD with renal or pulmonary dysfunction who received supportive care or interventions other than defibrotide sodium.

The safety of defibrotide sodium to support approval is based on data from 176 patients in the clinical development program for the treatment of VOD with renal and/or pulmonary dysfunction following HSCT.

The most common adverse events (incidence ≥10% and independent of causality) were hypotension, diarrhea, vomiting, nausea, and epistaxis. The most common serious adverse events (incidence ≥5% and independent of causality) were hypotension (11%) and pulmonary alveolar hemorrhage (7%).

HSCT preparation

Photo by Chad McNeeley

The US Food and Drug Administration (FDA) has approved the use of defibrotide sodium (Defitelio).

The product can now be used to treat adult and pediatric patients who develop hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction after receiving a hematopoietic stem cell transplant (HSCT).

Defibrotide sodium is the first FDA-approved therapy for patients with this rare, potentially fatal complication.

Defibrotide sodium is a product of Jazz Pharmaceuticals, Inc. The company said shipments of the drug to distribution channels will begin within a week.

The recommended dose and schedule for defibrotide sodium is 6.25 mg/kg every 6 hours, given as a 2-hour intravenous infusion, for at least 21 days, and continued until VOD resolution or up to 60 days of treatment.

In vitro defibrotide sodium has profibrinolytic activity. The use of defibrotide sodium is contraindicated in patients receiving concurrent anticoagulants or fibrinolytic therapies. Hemorrhage and hypersensitivity reactions are the major potential adverse reactions.

The FDA previously granted the defibrotide sodium application priority review status, and the drug received orphan drug designation from the FDA for the treatment of hepatic VOD.

Full prescribing information for defibrotide sodium can be found on the FDA website.

Trial results

The FDA’s approval of defibrotide sodium is supported by data in 528 patients treated on 3 studies: a phase 2 trial, a phase 3 trial, and an expanded access study. Data from the expanded access study were presented at the 2015 BMT Tandem Meetings, and data from the phase 3 trial were published in Blood earlier this year.

The 528 patients all had hepatic VOD with multi-organ dysfunction after HSCT. They received defibrotide sodium at 6.25 mg/kg intravenously every 6 hours until resolution of VOD.

The approval was based on survival at day +100 after HSCT. The day +100 survival rates for Study 1 (phase 3, n=102), Study 2 (phase 2, n=75), and Study 3 (expanded access, n=351) were 38%, 44%, and 45%, respectively.

Based on published reports and analyses of patient-level data, the day +100 survival rates were 21% to 31% for patients with hepatic VOD with renal or pulmonary dysfunction who received supportive care or interventions other than defibrotide sodium.

The safety of defibrotide sodium to support approval is based on data from 176 patients in the clinical development program for the treatment of VOD with renal and/or pulmonary dysfunction following HSCT.

The most common adverse events (incidence ≥10% and independent of causality) were hypotension, diarrhea, vomiting, nausea, and epistaxis. The most common serious adverse events (incidence ≥5% and independent of causality) were hypotension (11%) and pulmonary alveolar hemorrhage (7%).

HSCT preparation

Photo by Chad McNeeley

The US Food and Drug Administration (FDA) has approved the use of defibrotide sodium (Defitelio).

The product can now be used to treat adult and pediatric patients who develop hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction after receiving a hematopoietic stem cell transplant (HSCT).

Defibrotide sodium is the first FDA-approved therapy for patients with this rare, potentially fatal complication.

Defibrotide sodium is a product of Jazz Pharmaceuticals, Inc. The company said shipments of the drug to distribution channels will begin within a week.

The recommended dose and schedule for defibrotide sodium is 6.25 mg/kg every 6 hours, given as a 2-hour intravenous infusion, for at least 21 days, and continued until VOD resolution or up to 60 days of treatment.

In vitro defibrotide sodium has profibrinolytic activity. The use of defibrotide sodium is contraindicated in patients receiving concurrent anticoagulants or fibrinolytic therapies. Hemorrhage and hypersensitivity reactions are the major potential adverse reactions.

The FDA previously granted the defibrotide sodium application priority review status, and the drug received orphan drug designation from the FDA for the treatment of hepatic VOD.

Full prescribing information for defibrotide sodium can be found on the FDA website.

Trial results

The FDA’s approval of defibrotide sodium is supported by data in 528 patients treated on 3 studies: a phase 2 trial, a phase 3 trial, and an expanded access study. Data from the expanded access study were presented at the 2015 BMT Tandem Meetings, and data from the phase 3 trial were published in Blood earlier this year.

The 528 patients all had hepatic VOD with multi-organ dysfunction after HSCT. They received defibrotide sodium at 6.25 mg/kg intravenously every 6 hours until resolution of VOD.

The approval was based on survival at day +100 after HSCT. The day +100 survival rates for Study 1 (phase 3, n=102), Study 2 (phase 2, n=75), and Study 3 (expanded access, n=351) were 38%, 44%, and 45%, respectively.

Based on published reports and analyses of patient-level data, the day +100 survival rates were 21% to 31% for patients with hepatic VOD with renal or pulmonary dysfunction who received supportive care or interventions other than defibrotide sodium.

The safety of defibrotide sodium to support approval is based on data from 176 patients in the clinical development program for the treatment of VOD with renal and/or pulmonary dysfunction following HSCT.

The most common adverse events (incidence ≥10% and independent of causality) were hypotension, diarrhea, vomiting, nausea, and epistaxis. The most common serious adverse events (incidence ≥5% and independent of causality) were hypotension (11%) and pulmonary alveolar hemorrhage (7%).

Lab mouse

Researchers have developed a mouse model of an aggressive type of acute myeloid leukemia (AML) that, they believe, accurately replicates the human form of the disease.

The model replicates AML with co-occurring mutations in FLT3 and DNMT3A.

The researchers said they found that mice with Flt3-ITD and inducible deletion of Dnmt3a developed a rapidly lethal, completely penetrant, and transplantable AML of normal karyotype.

The team described this work in Cancer Discovery.

“Our goal was to create a model that was faithful to the human form of the disease that can be used for preclinical testing of potential cures,” said study author H. Leighton Grimes, PhD, of Cincinnati Children’s Hospital Medical Center in Ohio.

“Previous models were slow, difficult to analyze, and did not accurately represent the human disease. This model is rapid, fully penetrant, and completely spontaneous. We hope that it will open the way for other researchers to join us in attacking this particularly lethal AML subtype.”

Dr Grimes and his colleagues said they were able to look at the disease in a new way with the help of a powerful new core facility utilizing analytical tools related to single-cell RNA sequencing. The team used complementary single-cell analyses to identify the core leukemia-causing stem cells of the tumor.

“Before, researchers were comparing the gene expression patterns of one AML subtype to either normal cells or other AML subtypes,” said study author Sara Meyer, PhD, a fellow in the Grimes lab.

“That approach made it difficult to tease out the specific impact of Dnmt3a mutation. Instead, we isolated the variables and studied only human and murine AML with Flt3 mutation. Comparing Flt3-mutant AML with and without Dnmt3a mutation allowed us to more finely identify those patterns that were specific to the Dnmt3a mutation.”

With that more detailed understanding, the researchers gained new insights into the contributions of the Dnmt3a mutation to the disease.

First, their work confirms suspicions that low-level Dnmt3a activity is cancer-causing. Moreover, they discovered that reduced Dnmt3a function allows genes that are normally expressed only at early development stages of blood cell formation to continue expression at later stages, leading to the development of AML.

The researchers also found that, in mouse tumor cells, rescuing expression of Dnmt3a reversed the leukemia phenotypes and gene expression. But they said more research is warranted to determine if rescuing normal levels of DNMT3A function is a viable method for treating human AML.

The team also identified several potential treatment targets that are unique to this type of AML. In future studies, they plan to proceed with testing potential therapies.

Lab mouse

Researchers have developed a mouse model of an aggressive type of acute myeloid leukemia (AML) that, they believe, accurately replicates the human form of the disease.

The model replicates AML with co-occurring mutations in FLT3 and DNMT3A.

The researchers said they found that mice with Flt3-ITD and inducible deletion of Dnmt3a developed a rapidly lethal, completely penetrant, and transplantable AML of normal karyotype.

The team described this work in Cancer Discovery.

“Our goal was to create a model that was faithful to the human form of the disease that can be used for preclinical testing of potential cures,” said study author H. Leighton Grimes, PhD, of Cincinnati Children’s Hospital Medical Center in Ohio.

“Previous models were slow, difficult to analyze, and did not accurately represent the human disease. This model is rapid, fully penetrant, and completely spontaneous. We hope that it will open the way for other researchers to join us in attacking this particularly lethal AML subtype.”

Dr Grimes and his colleagues said they were able to look at the disease in a new way with the help of a powerful new core facility utilizing analytical tools related to single-cell RNA sequencing. The team used complementary single-cell analyses to identify the core leukemia-causing stem cells of the tumor.

“Before, researchers were comparing the gene expression patterns of one AML subtype to either normal cells or other AML subtypes,” said study author Sara Meyer, PhD, a fellow in the Grimes lab.

“That approach made it difficult to tease out the specific impact of Dnmt3a mutation. Instead, we isolated the variables and studied only human and murine AML with Flt3 mutation. Comparing Flt3-mutant AML with and without Dnmt3a mutation allowed us to more finely identify those patterns that were specific to the Dnmt3a mutation.”

With that more detailed understanding, the researchers gained new insights into the contributions of the Dnmt3a mutation to the disease.

First, their work confirms suspicions that low-level Dnmt3a activity is cancer-causing. Moreover, they discovered that reduced Dnmt3a function allows genes that are normally expressed only at early development stages of blood cell formation to continue expression at later stages, leading to the development of AML.

The researchers also found that, in mouse tumor cells, rescuing expression of Dnmt3a reversed the leukemia phenotypes and gene expression. But they said more research is warranted to determine if rescuing normal levels of DNMT3A function is a viable method for treating human AML.

The team also identified several potential treatment targets that are unique to this type of AML. In future studies, they plan to proceed with testing potential therapies.

Lab mouse

Researchers have developed a mouse model of an aggressive type of acute myeloid leukemia (AML) that, they believe, accurately replicates the human form of the disease.

The model replicates AML with co-occurring mutations in FLT3 and DNMT3A.

The researchers said they found that mice with Flt3-ITD and inducible deletion of Dnmt3a developed a rapidly lethal, completely penetrant, and transplantable AML of normal karyotype.

The team described this work in Cancer Discovery.

“Our goal was to create a model that was faithful to the human form of the disease that can be used for preclinical testing of potential cures,” said study author H. Leighton Grimes, PhD, of Cincinnati Children’s Hospital Medical Center in Ohio.

“Previous models were slow, difficult to analyze, and did not accurately represent the human disease. This model is rapid, fully penetrant, and completely spontaneous. We hope that it will open the way for other researchers to join us in attacking this particularly lethal AML subtype.”

Dr Grimes and his colleagues said they were able to look at the disease in a new way with the help of a powerful new core facility utilizing analytical tools related to single-cell RNA sequencing. The team used complementary single-cell analyses to identify the core leukemia-causing stem cells of the tumor.

“Before, researchers were comparing the gene expression patterns of one AML subtype to either normal cells or other AML subtypes,” said study author Sara Meyer, PhD, a fellow in the Grimes lab.

“That approach made it difficult to tease out the specific impact of Dnmt3a mutation. Instead, we isolated the variables and studied only human and murine AML with Flt3 mutation. Comparing Flt3-mutant AML with and without Dnmt3a mutation allowed us to more finely identify those patterns that were specific to the Dnmt3a mutation.”

With that more detailed understanding, the researchers gained new insights into the contributions of the Dnmt3a mutation to the disease.

First, their work confirms suspicions that low-level Dnmt3a activity is cancer-causing. Moreover, they discovered that reduced Dnmt3a function allows genes that are normally expressed only at early development stages of blood cell formation to continue expression at later stages, leading to the development of AML.

The researchers also found that, in mouse tumor cells, rescuing expression of Dnmt3a reversed the leukemia phenotypes and gene expression. But they said more research is warranted to determine if rescuing normal levels of DNMT3A function is a viable method for treating human AML.

The team also identified several potential treatment targets that are unique to this type of AML. In future studies, they plan to proceed with testing potential therapies.

The US Food and Drug Administration (FDA) is allowing the use of an investigational test to screen blood donations for Zika virus.

The test, known as the cobas® Zika test, has not been granted FDA clearance or approval, but it may be used under an investigational new drug application protocol for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into a clinical trial for the test, as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

By authorizing use of the cobas® Zika test, the FDA is allowing blood establishments in Puerto Rico—a US territory with local, mosquito-borne transmission of the Zika virus—to resume collecting donations of whole blood and blood components.

“The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood supply, especially for those US territories already experiencing active transmission,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.”

About the test

The cobas® Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human

blood donors.

The test is based on fully automated sample preparation (nucleic acid extraction and purification), followed by PCR amplification and detection.

The cobas® Zika test is manufactured by Roche and is intended for use with Roche’s cobas® 6800/8800 Systems.

The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 6800/8800 software, which assigns test results for all tests as non-reactive, reactive, or invalid.

“The cobas® Zika test has been specifically designed utilizing the generic cobas® omni Utility Channel on the cobas® 6800/8800 Systems,” said Roland Diggelmann, chief operating officer of Roche Diagnostics.

“These fully automated, high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion.”

Test availability

Initially, the cobas® Zika test will be deployed to screen blood donations collected locally in Puerto Rico. It is expected that this testing will enable the

reinstatement of the blood services in Puerto Rico and reduce the reliance of blood importation from other areas in the US.

The second stage of deployment for the cobas® Zika test will be to prepare for screening of blood donations collected by blood services in the southern US.

In addition, Roche said it is working with regulators around the world to determine the path forward to implement the cobas® Zika test for blood screening.

Implications for Puerto Rico

On February 16, the FDA issued a guidance for US blood establishments to reduce the risk of transfusion-transmitted Zika virus. In the guidance, the FDA recommended that areas with active transmission of Zika virus obtain whole blood and blood components from areas without active transmission of the virus.

As a result, local blood collection in Puerto Rico was suspended. On March 7, the Department of Health and Human Services announced that it arranged for shipments of blood products from the continental US to Puerto Rico.

The FDA guidance also states that establishments in areas with active Zika transmission may collect locally if a licensed or investigational test for screening donated blood is available.

Once screening of blood donations for Zika virus using the cobas® Zika test begins, blood establishments in Puerto Rico may resume collecting donations of whole blood and blood components. However, the FDA’s recommendations for Zika blood donor deferrals remain in place.

The US Food and Drug Administration (FDA) is allowing the use of an investigational test to screen blood donations for Zika virus.

The test, known as the cobas® Zika test, has not been granted FDA clearance or approval, but it may be used under an investigational new drug application protocol for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into a clinical trial for the test, as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

By authorizing use of the cobas® Zika test, the FDA is allowing blood establishments in Puerto Rico—a US territory with local, mosquito-borne transmission of the Zika virus—to resume collecting donations of whole blood and blood components.

“The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood supply, especially for those US territories already experiencing active transmission,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.”

About the test

The cobas® Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human

blood donors.

The test is based on fully automated sample preparation (nucleic acid extraction and purification), followed by PCR amplification and detection.

The cobas® Zika test is manufactured by Roche and is intended for use with Roche’s cobas® 6800/8800 Systems.

The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 6800/8800 software, which assigns test results for all tests as non-reactive, reactive, or invalid.

“The cobas® Zika test has been specifically designed utilizing the generic cobas® omni Utility Channel on the cobas® 6800/8800 Systems,” said Roland Diggelmann, chief operating officer of Roche Diagnostics.

“These fully automated, high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion.”

Test availability

Initially, the cobas® Zika test will be deployed to screen blood donations collected locally in Puerto Rico. It is expected that this testing will enable the

reinstatement of the blood services in Puerto Rico and reduce the reliance of blood importation from other areas in the US.

The second stage of deployment for the cobas® Zika test will be to prepare for screening of blood donations collected by blood services in the southern US.

In addition, Roche said it is working with regulators around the world to determine the path forward to implement the cobas® Zika test for blood screening.

Implications for Puerto Rico

On February 16, the FDA issued a guidance for US blood establishments to reduce the risk of transfusion-transmitted Zika virus. In the guidance, the FDA recommended that areas with active transmission of Zika virus obtain whole blood and blood components from areas without active transmission of the virus.

As a result, local blood collection in Puerto Rico was suspended. On March 7, the Department of Health and Human Services announced that it arranged for shipments of blood products from the continental US to Puerto Rico.

The FDA guidance also states that establishments in areas with active Zika transmission may collect locally if a licensed or investigational test for screening donated blood is available.

Once screening of blood donations for Zika virus using the cobas® Zika test begins, blood establishments in Puerto Rico may resume collecting donations of whole blood and blood components. However, the FDA’s recommendations for Zika blood donor deferrals remain in place.

The US Food and Drug Administration (FDA) is allowing the use of an investigational test to screen blood donations for Zika virus.

The test, known as the cobas® Zika test, has not been granted FDA clearance or approval, but it may be used under an investigational new drug application protocol for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into a clinical trial for the test, as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

By authorizing use of the cobas® Zika test, the FDA is allowing blood establishments in Puerto Rico—a US territory with local, mosquito-borne transmission of the Zika virus—to resume collecting donations of whole blood and blood components.

“The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood supply, especially for those US territories already experiencing active transmission,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.”

About the test

The cobas® Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human

blood donors.

The test is based on fully automated sample preparation (nucleic acid extraction and purification), followed by PCR amplification and detection.

The cobas® Zika test is manufactured by Roche and is intended for use with Roche’s cobas® 6800/8800 Systems.

The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 6800/8800 software, which assigns test results for all tests as non-reactive, reactive, or invalid.

“The cobas® Zika test has been specifically designed utilizing the generic cobas® omni Utility Channel on the cobas® 6800/8800 Systems,” said Roland Diggelmann, chief operating officer of Roche Diagnostics.

“These fully automated, high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion.”

Test availability

Initially, the cobas® Zika test will be deployed to screen blood donations collected locally in Puerto Rico. It is expected that this testing will enable the

reinstatement of the blood services in Puerto Rico and reduce the reliance of blood importation from other areas in the US.

The second stage of deployment for the cobas® Zika test will be to prepare for screening of blood donations collected by blood services in the southern US.

In addition, Roche said it is working with regulators around the world to determine the path forward to implement the cobas® Zika test for blood screening.

Implications for Puerto Rico

On February 16, the FDA issued a guidance for US blood establishments to reduce the risk of transfusion-transmitted Zika virus. In the guidance, the FDA recommended that areas with active transmission of Zika virus obtain whole blood and blood components from areas without active transmission of the virus.

As a result, local blood collection in Puerto Rico was suspended. On March 7, the Department of Health and Human Services announced that it arranged for shipments of blood products from the continental US to Puerto Rico.

The FDA guidance also states that establishments in areas with active Zika transmission may collect locally if a licensed or investigational test for screening donated blood is available.

Once screening of blood donations for Zika virus using the cobas® Zika test begins, blood establishments in Puerto Rico may resume collecting donations of whole blood and blood components. However, the FDA’s recommendations for Zika blood donor deferrals remain in place.

Hormone therapy – estradiol with or without progesterone – only limits the progression of subclinical atherosclerosis if it is initiated within 6 years of menopause onset, according to a report published online March 30 in the New England Journal of Medicine.

The “hormone-timing hypothesis” posits that hormone therapy’s beneficial effects on atherosclerosis depend on the timing of initiating that therapy relative to menopause. To test this hypothesis, researchers began the ELITE study (Early versus Late Intervention Trial with Estradiol) in 2002, using serial noninvasive measurements of carotid-artery intima-media thickness (CIMT) as a marker of atherosclerosis progression.

©pixologicstudio/Thinkstock.com

Several other studies since 2002 have reported that the timing hypothesis appears to be valid, wrote Dr. Howard N. Hodis of the Atherosclerosis Research Unit, University of Southern California, Los Angeles, and his associates.

Their single-center trial involved 643 healthy postmenopausal women who had no diabetes and no evidence of cardiovascular disease at baseline, and who were randomly assigned to receive either daily oral estradiol or a matching placebo for 5 years. Women who had an intact uterus and took active estradiol also received a 4% micronized progesterone vaginal gel, while those who had an intact uterus and took placebo also received a matching placebo gel.

The participants were stratified according to the number of years they were past menopause: less than 6 years (271 women in the “early” group) or more than 10 years (372 in the “late” group).

A total of 137 women in the early group and 186 women in the late group were assigned to active estradiol, while 134 women in the early group and 186 women in the late group were assigned to placebo. As expected, serum estradiol levels were at least 3 times higher among women assigned to active treatment, compared with those assigned to placebo.

The primary outcome – the effect of hormone therapy on CIMT progression – differed by timing of the initiation of treatment. In the “early” group, the mean CIMT progression rate was decreased by 0.0034 mm per year with estradiol, compared with placebo.

In contrast, in the “late” group, the rates of CIMT progression were not significantly different between estradiol and placebo, the investigators wrote (N Engl J Med. 2016;374:1221-31. doi: 10.1056/NEJMoa1505241).

This beneficial effect remained significant in a sensitivity analysis restricted only to study participants who showed at least 80% adherence to their assigned treatment. The benefit also remained significant in a post-hoc analysis comparing women who took estradiol alone against those who took estradiol plus progestogen, as well as in a separate analysis comparing women who used lipid-lowering and/or hypertensive medications against those who did not.

The findings add further evidence in favor of the hormone timing hypothesis. The effect of estradiol therapy on CIMT progression was significantly modified by time since menopause (P = .007 for the interaction), the researchers wrote.

Cardiac computer tomography (CT) was used as a different method of assessing coronary atherosclerosis in a subgroup of 167 women in the early group (88 receiving estradiol and 79 receiving placebo) and 214 in the late group (101 receiving estradiol and 113 receiving placebo). The timing of estradiol treatment did not affect coronary artery calcium and other cardiac CT measures. This is consistent with previous reports that hormone therapy has no significant effect on established lesions in the coronary arteries, the researchers wrote.

The ELITE trial was funded by the National Institute on Aging. Dr. Hodis reported having no relevant financial disclosures; two of his associates reported ties to GE and TherapeuticsMD.

Hormone therapy – estradiol with or without progesterone – only limits the progression of subclinical atherosclerosis if it is initiated within 6 years of menopause onset, according to a report published online March 30 in the New England Journal of Medicine.

The “hormone-timing hypothesis” posits that hormone therapy’s beneficial effects on atherosclerosis depend on the timing of initiating that therapy relative to menopause. To test this hypothesis, researchers began the ELITE study (Early versus Late Intervention Trial with Estradiol) in 2002, using serial noninvasive measurements of carotid-artery intima-media thickness (CIMT) as a marker of atherosclerosis progression.

©pixologicstudio/Thinkstock.com

Several other studies since 2002 have reported that the timing hypothesis appears to be valid, wrote Dr. Howard N. Hodis of the Atherosclerosis Research Unit, University of Southern California, Los Angeles, and his associates.

Their single-center trial involved 643 healthy postmenopausal women who had no diabetes and no evidence of cardiovascular disease at baseline, and who were randomly assigned to receive either daily oral estradiol or a matching placebo for 5 years. Women who had an intact uterus and took active estradiol also received a 4% micronized progesterone vaginal gel, while those who had an intact uterus and took placebo also received a matching placebo gel.

The participants were stratified according to the number of years they were past menopause: less than 6 years (271 women in the “early” group) or more than 10 years (372 in the “late” group).

A total of 137 women in the early group and 186 women in the late group were assigned to active estradiol, while 134 women in the early group and 186 women in the late group were assigned to placebo. As expected, serum estradiol levels were at least 3 times higher among women assigned to active treatment, compared with those assigned to placebo.

The primary outcome – the effect of hormone therapy on CIMT progression – differed by timing of the initiation of treatment. In the “early” group, the mean CIMT progression rate was decreased by 0.0034 mm per year with estradiol, compared with placebo.

In contrast, in the “late” group, the rates of CIMT progression were not significantly different between estradiol and placebo, the investigators wrote (N Engl J Med. 2016;374:1221-31. doi: 10.1056/NEJMoa1505241).

This beneficial effect remained significant in a sensitivity analysis restricted only to study participants who showed at least 80% adherence to their assigned treatment. The benefit also remained significant in a post-hoc analysis comparing women who took estradiol alone against those who took estradiol plus progestogen, as well as in a separate analysis comparing women who used lipid-lowering and/or hypertensive medications against those who did not.

The findings add further evidence in favor of the hormone timing hypothesis. The effect of estradiol therapy on CIMT progression was significantly modified by time since menopause (P = .007 for the interaction), the researchers wrote.

Cardiac computer tomography (CT) was used as a different method of assessing coronary atherosclerosis in a subgroup of 167 women in the early group (88 receiving estradiol and 79 receiving placebo) and 214 in the late group (101 receiving estradiol and 113 receiving placebo). The timing of estradiol treatment did not affect coronary artery calcium and other cardiac CT measures. This is consistent with previous reports that hormone therapy has no significant effect on established lesions in the coronary arteries, the researchers wrote.

The ELITE trial was funded by the National Institute on Aging. Dr. Hodis reported having no relevant financial disclosures; two of his associates reported ties to GE and TherapeuticsMD.

Hormone therapy – estradiol with or without progesterone – only limits the progression of subclinical atherosclerosis if it is initiated within 6 years of menopause onset, according to a report published online March 30 in the New England Journal of Medicine.

The “hormone-timing hypothesis” posits that hormone therapy’s beneficial effects on atherosclerosis depend on the timing of initiating that therapy relative to menopause. To test this hypothesis, researchers began the ELITE study (Early versus Late Intervention Trial with Estradiol) in 2002, using serial noninvasive measurements of carotid-artery intima-media thickness (CIMT) as a marker of atherosclerosis progression.

©pixologicstudio/Thinkstock.com

Several other studies since 2002 have reported that the timing hypothesis appears to be valid, wrote Dr. Howard N. Hodis of the Atherosclerosis Research Unit, University of Southern California, Los Angeles, and his associates.

Their single-center trial involved 643 healthy postmenopausal women who had no diabetes and no evidence of cardiovascular disease at baseline, and who were randomly assigned to receive either daily oral estradiol or a matching placebo for 5 years. Women who had an intact uterus and took active estradiol also received a 4% micronized progesterone vaginal gel, while those who had an intact uterus and took placebo also received a matching placebo gel.

The participants were stratified according to the number of years they were past menopause: less than 6 years (271 women in the “early” group) or more than 10 years (372 in the “late” group).

A total of 137 women in the early group and 186 women in the late group were assigned to active estradiol, while 134 women in the early group and 186 women in the late group were assigned to placebo. As expected, serum estradiol levels were at least 3 times higher among women assigned to active treatment, compared with those assigned to placebo.

The primary outcome – the effect of hormone therapy on CIMT progression – differed by timing of the initiation of treatment. In the “early” group, the mean CIMT progression rate was decreased by 0.0034 mm per year with estradiol, compared with placebo.

In contrast, in the “late” group, the rates of CIMT progression were not significantly different between estradiol and placebo, the investigators wrote (N Engl J Med. 2016;374:1221-31. doi: 10.1056/NEJMoa1505241).

This beneficial effect remained significant in a sensitivity analysis restricted only to study participants who showed at least 80% adherence to their assigned treatment. The benefit also remained significant in a post-hoc analysis comparing women who took estradiol alone against those who took estradiol plus progestogen, as well as in a separate analysis comparing women who used lipid-lowering and/or hypertensive medications against those who did not.

The findings add further evidence in favor of the hormone timing hypothesis. The effect of estradiol therapy on CIMT progression was significantly modified by time since menopause (P = .007 for the interaction), the researchers wrote.

Cardiac computer tomography (CT) was used as a different method of assessing coronary atherosclerosis in a subgroup of 167 women in the early group (88 receiving estradiol and 79 receiving placebo) and 214 in the late group (101 receiving estradiol and 113 receiving placebo). The timing of estradiol treatment did not affect coronary artery calcium and other cardiac CT measures. This is consistent with previous reports that hormone therapy has no significant effect on established lesions in the coronary arteries, the researchers wrote.

The ELITE trial was funded by the National Institute on Aging. Dr. Hodis reported having no relevant financial disclosures; two of his associates reported ties to GE and TherapeuticsMD.

Eating a Mediterranean diet full of fruits, vegetables, fish, nuts, legumes, and whole grains is associated with a slightly lower risk of hip fracture in women, according to a study published online ahead of print in JAMA Internal Medicine.

Researchers analyzed data on diet and fracture risk in more than 90,000 postmenopausal women (average age, 63.6 years) who were followed for an average of almost 16 years. Diet quality and adherence were assessed by scores on 4 scales: the alternate Mediterranean Diet (aMED); the Healthy Eating Index 2010 (HEI-2010); the Alternate Healthy Eating Index 2010 (AHEI-2010); and the Dietary Approaches to Stop Hypertension (DASH) diet.

Women who scored the highest for adherence to a Mediterranean diet were at lower risk for hip fractures, although the absolute risk reduction was 0.29%. There was no association between a Mediterranean diet and total fracture risk.

A higher HEI-2010 or DASH score was inversely related to the risk of hip fracture, but the finding was not statistically significant. There was no association between HEI-2010, DASH and total fracture risk. The highest scores for AHEI-2010 were not significantly associated with hip or total fracture risk.

Eating a Mediterranean diet full of fruits, vegetables, fish, nuts, legumes, and whole grains is associated with a slightly lower risk of hip fracture in women, according to a study published online ahead of print in JAMA Internal Medicine.

Researchers analyzed data on diet and fracture risk in more than 90,000 postmenopausal women (average age, 63.6 years) who were followed for an average of almost 16 years. Diet quality and adherence were assessed by scores on 4 scales: the alternate Mediterranean Diet (aMED); the Healthy Eating Index 2010 (HEI-2010); the Alternate Healthy Eating Index 2010 (AHEI-2010); and the Dietary Approaches to Stop Hypertension (DASH) diet.

Women who scored the highest for adherence to a Mediterranean diet were at lower risk for hip fractures, although the absolute risk reduction was 0.29%. There was no association between a Mediterranean diet and total fracture risk.

A higher HEI-2010 or DASH score was inversely related to the risk of hip fracture, but the finding was not statistically significant. There was no association between HEI-2010, DASH and total fracture risk. The highest scores for AHEI-2010 were not significantly associated with hip or total fracture risk.

Eating a Mediterranean diet full of fruits, vegetables, fish, nuts, legumes, and whole grains is associated with a slightly lower risk of hip fracture in women, according to a study published online ahead of print in JAMA Internal Medicine.

Researchers analyzed data on diet and fracture risk in more than 90,000 postmenopausal women (average age, 63.6 years) who were followed for an average of almost 16 years. Diet quality and adherence were assessed by scores on 4 scales: the alternate Mediterranean Diet (aMED); the Healthy Eating Index 2010 (HEI-2010); the Alternate Healthy Eating Index 2010 (AHEI-2010); and the Dietary Approaches to Stop Hypertension (DASH) diet.

Women who scored the highest for adherence to a Mediterranean diet were at lower risk for hip fractures, although the absolute risk reduction was 0.29%. There was no association between a Mediterranean diet and total fracture risk.

A higher HEI-2010 or DASH score was inversely related to the risk of hip fracture, but the finding was not statistically significant. There was no association between HEI-2010, DASH and total fracture risk. The highest scores for AHEI-2010 were not significantly associated with hip or total fracture risk.

An increasing number of adolescents are undergoing ulnar lateral ligament (UCL) surgery to repair a pitching-related elbow injury, according to a study published online ahead of print in the March issue of the American Journal of Sports Medicine.

Analyzing a database of all ambulatory discharges in New York state, researchers found that 444 patients underwent surgery to repair their UCL between 2002 and 2011. The median age of study participants was 21; most were male.

The total volume of UCL surgeries increased nearly 200% during that time, while the number of UCL reconstructions per 100,000 people tripled from 0.15 to 0.45. Almost all of the growth occurred in two age groups, 17- to 18-year-olds and 19- to 20-year-olds. Patients who had private insurance were 25 times more likely to undergo UCL construction than those with Medicaid.

An increasing number of adolescents are undergoing ulnar lateral ligament (UCL) surgery to repair a pitching-related elbow injury, according to a study published online ahead of print in the March issue of the American Journal of Sports Medicine.

Analyzing a database of all ambulatory discharges in New York state, researchers found that 444 patients underwent surgery to repair their UCL between 2002 and 2011. The median age of study participants was 21; most were male.

The total volume of UCL surgeries increased nearly 200% during that time, while the number of UCL reconstructions per 100,000 people tripled from 0.15 to 0.45. Almost all of the growth occurred in two age groups, 17- to 18-year-olds and 19- to 20-year-olds. Patients who had private insurance were 25 times more likely to undergo UCL construction than those with Medicaid.

An increasing number of adolescents are undergoing ulnar lateral ligament (UCL) surgery to repair a pitching-related elbow injury, according to a study published online ahead of print in the March issue of the American Journal of Sports Medicine.

Analyzing a database of all ambulatory discharges in New York state, researchers found that 444 patients underwent surgery to repair their UCL between 2002 and 2011. The median age of study participants was 21; most were male.

The total volume of UCL surgeries increased nearly 200% during that time, while the number of UCL reconstructions per 100,000 people tripled from 0.15 to 0.45. Almost all of the growth occurred in two age groups, 17- to 18-year-olds and 19- to 20-year-olds. Patients who had private insurance were 25 times more likely to undergo UCL construction than those with Medicaid.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

Q2: ANSWER: D

Critique

This series of endoscopic findings shows changes consistent with inflammation of the cuff.

Up to 20%-30% of patients with ulcerative colitis ultimately require colectomy due to medically refractory colitis or to the development of dysplasia. A total abdominal protocolectomy with ileal pouch anal anastomosis has become the surgical procedure of choice for most ulcerative colitis patients who require surgery.

There are both early and late complications of this type of surgery. Late complications include anastomotic stricture, pouchitis, abscesses, inflammation of the cuff or cuffitis, and functional difficulties such as irritable pouch syndrome, anal pain, and pouch stasis. Patients may also present with inflammation of the pouch and the prepouch ileum that is consistent with Crohn’s disease. Endoscopy can help to narrow down the differential diagnosis of these pouch complications.

In this series of photos the prepouch ileum has no inflammation. The pouch also has no ulcerations or evidence of pouchitis or Crohn’s disease. The cuff is inflamed consistent with a diagnosis of cuffitis. If the inflammation becomes difficult to manage, immunosuppressive therapy may be required but at this point it is reasonable to start with topical therapy to the inflamed area.

Reference

1. Li, Y. Shen, B. Evaluating pouch problems. Gastroenterology Clinics North Am. 2012;41:355-78.
2. Shen, G. Diagnosis and management of post-operative ileal pouch disorders. Clin Colon Rectal Surg. 2010;23:259-68.

Q2: ANSWER: D

Critique

This series of endoscopic findings shows changes consistent with inflammation of the cuff.

Up to 20%-30% of patients with ulcerative colitis ultimately require colectomy due to medically refractory colitis or to the development of dysplasia. A total abdominal protocolectomy with ileal pouch anal anastomosis has become the surgical procedure of choice for most ulcerative colitis patients who require surgery.

There are both early and late complications of this type of surgery. Late complications include anastomotic stricture, pouchitis, abscesses, inflammation of the cuff or cuffitis, and functional difficulties such as irritable pouch syndrome, anal pain, and pouch stasis. Patients may also present with inflammation of the pouch and the prepouch ileum that is consistent with Crohn’s disease. Endoscopy can help to narrow down the differential diagnosis of these pouch complications.

In this series of photos the prepouch ileum has no inflammation. The pouch also has no ulcerations or evidence of pouchitis or Crohn’s disease. The cuff is inflamed consistent with a diagnosis of cuffitis. If the inflammation becomes difficult to manage, immunosuppressive therapy may be required but at this point it is reasonable to start with topical therapy to the inflamed area.

Reference

1. Li, Y. Shen, B. Evaluating pouch problems. Gastroenterology Clinics North Am. 2012;41:355-78.
2. Shen, G. Diagnosis and management of post-operative ileal pouch disorders. Clin Colon Rectal Surg. 2010;23:259-68.

Q2: ANSWER: D

Critique

This series of endoscopic findings shows changes consistent with inflammation of the cuff.

Up to 20%-30% of patients with ulcerative colitis ultimately require colectomy due to medically refractory colitis or to the development of dysplasia. A total abdominal protocolectomy with ileal pouch anal anastomosis has become the surgical procedure of choice for most ulcerative colitis patients who require surgery.

There are both early and late complications of this type of surgery. Late complications include anastomotic stricture, pouchitis, abscesses, inflammation of the cuff or cuffitis, and functional difficulties such as irritable pouch syndrome, anal pain, and pouch stasis. Patients may also present with inflammation of the pouch and the prepouch ileum that is consistent with Crohn’s disease. Endoscopy can help to narrow down the differential diagnosis of these pouch complications.

In this series of photos the prepouch ileum has no inflammation. The pouch also has no ulcerations or evidence of pouchitis or Crohn’s disease. The cuff is inflamed consistent with a diagnosis of cuffitis. If the inflammation becomes difficult to manage, immunosuppressive therapy may be required but at this point it is reasonable to start with topical therapy to the inflamed area.

Reference

1. Li, Y. Shen, B. Evaluating pouch problems. Gastroenterology Clinics North Am. 2012;41:355-78.
2. Shen, G. Diagnosis and management of post-operative ileal pouch disorders. Clin Colon Rectal Surg. 2010;23:259-68.

Until recently, I was not a member of the American Medical Association (AMA). For the past 30 years, I chose not to join because I was troubled by the organization’s direction and the way it seemed to be dominated by special interests. But things have changed—and so has its focus.

The AMA has a new strategy entitled, “A vision for a healthier nation.” Well aligned with the needs of family physicians, the campaign addresses 3 specific areas: better patient health, smarter medical training, and sustainable practices.

Better patient health. The AMA is partnering with several public health-oriented organizations, including the Centers for Disease Control and Prevention, to reach out to individuals with diabetes, cardiovascular disease, and cardiac risk factors to promote primary and secondary prevention strategies at a population level. This is a very different posture than the AMA assumed in the early 20th century, when it was more likely to resist public health programs.

Smarter medical training. Under the direction of family physician Susan Skochelak, MD, MPH, group vice president for medical education, the AMA has provided grant funding to 31 US medical schools to assist with curricular redesign and innovation to train physicians to be effective leaders in the health care system of the future.

The new AMA is a different organization from the one I chose not to join for the past 30 years.

Sustainable practices. This area houses what is perhaps the AMA’s most meaningful new program for primary care clinicians. Under the leadership of general internist Christine A. Sinsky, MD, PhD, vice president for professional satisfaction, the AMA has developed a suite of Web tools to help physicians improve the quality and efficiency of their clinical practices.

Specifically, the AMA is offering the STEPS Forward program, a collection of interactive, educational modules developed by physicians for physicians to help address common practice challenges and to achieve the quadruple aim of a better patient experience, better population health, lower overall costs, and improved professional satisfaction.¹ The 27 modules are self-directed, group learning exercises that encompass a wide range of thorny issues we deal with on a daily basis. A sampling of topics includes: preparing your practice for change, revenue cycle management, synchronized prescription renewals, and creating a strong team culture.

Programs like these are evidence that the new AMA is a different organization from the one I chose not to join for the past 30 years. I am now a member. Check it out; it might be time for you to join, too.

Until recently, I was not a member of the American Medical Association (AMA). For the past 30 years, I chose not to join because I was troubled by the organization’s direction and the way it seemed to be dominated by special interests. But things have changed—and so has its focus.

The AMA has a new strategy entitled, “A vision for a healthier nation.” Well aligned with the needs of family physicians, the campaign addresses 3 specific areas: better patient health, smarter medical training, and sustainable practices.

Better patient health. The AMA is partnering with several public health-oriented organizations, including the Centers for Disease Control and Prevention, to reach out to individuals with diabetes, cardiovascular disease, and cardiac risk factors to promote primary and secondary prevention strategies at a population level. This is a very different posture than the AMA assumed in the early 20th century, when it was more likely to resist public health programs.

Smarter medical training. Under the direction of family physician Susan Skochelak, MD, MPH, group vice president for medical education, the AMA has provided grant funding to 31 US medical schools to assist with curricular redesign and innovation to train physicians to be effective leaders in the health care system of the future.

The new AMA is a different organization from the one I chose not to join for the past 30 years.

Sustainable practices. This area houses what is perhaps the AMA’s most meaningful new program for primary care clinicians. Under the leadership of general internist Christine A. Sinsky, MD, PhD, vice president for professional satisfaction, the AMA has developed a suite of Web tools to help physicians improve the quality and efficiency of their clinical practices.

Specifically, the AMA is offering the STEPS Forward program, a collection of interactive, educational modules developed by physicians for physicians to help address common practice challenges and to achieve the quadruple aim of a better patient experience, better population health, lower overall costs, and improved professional satisfaction.¹ The 27 modules are self-directed, group learning exercises that encompass a wide range of thorny issues we deal with on a daily basis. A sampling of topics includes: preparing your practice for change, revenue cycle management, synchronized prescription renewals, and creating a strong team culture.

Programs like these are evidence that the new AMA is a different organization from the one I chose not to join for the past 30 years. I am now a member. Check it out; it might be time for you to join, too.

Until recently, I was not a member of the American Medical Association (AMA). For the past 30 years, I chose not to join because I was troubled by the organization’s direction and the way it seemed to be dominated by special interests. But things have changed—and so has its focus.

The AMA has a new strategy entitled, “A vision for a healthier nation.” Well aligned with the needs of family physicians, the campaign addresses 3 specific areas: better patient health, smarter medical training, and sustainable practices.

Better patient health. The AMA is partnering with several public health-oriented organizations, including the Centers for Disease Control and Prevention, to reach out to individuals with diabetes, cardiovascular disease, and cardiac risk factors to promote primary and secondary prevention strategies at a population level. This is a very different posture than the AMA assumed in the early 20th century, when it was more likely to resist public health programs.

Smarter medical training. Under the direction of family physician Susan Skochelak, MD, MPH, group vice president for medical education, the AMA has provided grant funding to 31 US medical schools to assist with curricular redesign and innovation to train physicians to be effective leaders in the health care system of the future.

The new AMA is a different organization from the one I chose not to join for the past 30 years.

Sustainable practices. This area houses what is perhaps the AMA’s most meaningful new program for primary care clinicians. Under the leadership of general internist Christine A. Sinsky, MD, PhD, vice president for professional satisfaction, the AMA has developed a suite of Web tools to help physicians improve the quality and efficiency of their clinical practices.

Specifically, the AMA is offering the STEPS Forward program, a collection of interactive, educational modules developed by physicians for physicians to help address common practice challenges and to achieve the quadruple aim of a better patient experience, better population health, lower overall costs, and improved professional satisfaction.¹ The 27 modules are self-directed, group learning exercises that encompass a wide range of thorny issues we deal with on a daily basis. A sampling of topics includes: preparing your practice for change, revenue cycle management, synchronized prescription renewals, and creating a strong team culture.

Programs like these are evidence that the new AMA is a different organization from the one I chose not to join for the past 30 years. I am now a member. Check it out; it might be time for you to join, too.