A safety signal of pulmonary embolism and increased mortality has emerged in a postmarketing trial of tofacitinib (Xeljanz) in patients with rheumatoid arthritis, the Food and Drug Administration reported.

The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.

Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.

The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.

Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.

The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.

“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.

Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.

“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.

While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.

A safety signal of pulmonary embolism and increased mortality has emerged in a postmarketing trial of tofacitinib (Xeljanz) in patients with rheumatoid arthritis, the Food and Drug Administration reported.

The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.

Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.

The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.

Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.

The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.

“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.

Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.

“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.

While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.

A safety signal of pulmonary embolism and increased mortality has emerged in a postmarketing trial of tofacitinib (Xeljanz) in patients with rheumatoid arthritis, the Food and Drug Administration reported.

The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.

Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.

The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.

Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.

The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.

“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.

Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.

“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.

While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.

A 60-year-old man is sent by his new employer to your urgent care for a pre-employment Department of Transportation (DOT) physical to obtain clearance to drive a commercial motor vehicle. His medical history is significant for hypertension, for which he takes lisinopril. Otherwise, he is healthy, with normal vital signs. His physical exam is unremarkable, but the urine sample is notably positive for glucose. A fingerstick glucose test yields a measurement of 212 mg/dL. What is your next appropriate step to medically clear the patient to drive commercially?

Commercial motor vehicle (CMV) drivers are mandated by the Federal Motor Carrier Safety Administration (FMCSA) to receive a DOT physical examination by a licensed medical examiner. To qualify to perform the exam, physician assistants, advanced practice nurses, physicians, and chiropractors must complete an educational program and pass a written certification examination.¹ Subsequently, the examiners are placed on a national registry—the National Registry of Certified Medical Examiners—with the mission to improve highway safety by determining whether a CMV driver’s health meets standards and guidelines set by the FMCSA.²

Under current guidelines, a DOT physical exam for a healthy CMV driver is considered valid for a maximum of 24 months. However, some diseases and medications require frequent follow-up, which can shorten the length of time a driver can be medically cleared to operate a CMV. Furthermore, certain conditions can disqualify the driver from meeting the necessary standards required for medical certification.

This case presentation offers the opportunity to review the requirements for evaluation and certification of a CMV driver with new-onset hyperglycemia and, ultimately, diabetes. In the United States, types 1 and 2 diabetes are estimated to affect 30.3 million people.³ About 33% of CMV drivers have been diagnosed with diabetes, which is significant since research has demonstrated an increased risk for crashes in individuals with diabetes, due to potential incapacitation from hypoglycemia.^4-6

Thus, for practitioners and medical examiners, it is prudent to screen and manage diabetes in CMV drivers. In fact, over the past 15 years, federal regulations have stipulated that any driver with diabetes requiring insulin for control was disqualified from this type of work.⁷ This standard was developed in response to the increased risk for hypoglycemic reactions with the use of insulin. However, in September 2018, the FMCSA revised this regulation, permitting individuals with a stable insulin regimen and properly controlled diabetes to be qualified to operate a CMV. As a result, for drivers requiring insulin, the treating clinician must complete a standardized form within 45 days of the DOT exam, documenting management of the patient’s diabetes.⁸ For drivers with diabetes who do not require insulin, determinations are made on a case-by-case basis, with discernment of the driver’s ability to manage the disease and concurrently meet other standards for qualification.

HEALTH HISTORY AND EXAMINATION

Each CMV driver completes a standard medical history form that asks about specific medications, surgeries, or medical conditions, including diabetes or blood glucose problems. Subsequently, the driver and, ultimately, the medical examiner must expand upon and discuss every “yes” response to this questionnaire.

Regarding diabetes, the examiner should determine whether the disease is controlled by diet, pills, and/or insulin, with clarification of the doses, frequency, and prescriber. In addition, the examiner should review and document glucose control, blood glucose monitoring, history of hypoglycemic episodes, and episodes of fainting, dizziness, or loss of consciousness.⁷

Continue to: The physical exam should focus on...

The physical exam should focus on identifying signs of complications from diabetes, such as retinopathy, nephropathy, or peripheral neuropathy. At each certification visit, the examiner should assess the patient’s height and weight, BMI, vision, hearing, blood pressure, and heart rate, and perform urinalysis to screen for proteinuria or glycosuria. A fingerstick test to obtain a random blood glucose reading is often performed in a driver with glycosuria.

Likewise, the A1C level should be documented in every patient with new-onset or known diabetes, with the recommendation from the FMCSA that a level >10% is an indicator of poor glucose control.⁷ It is important to note that an A1C level up to 10% is not the glycemic target recognized by the American Diabetes Association and the American Association of Clinical Endocrinologists. The FMCSA is focused more on hypoglycemic concerns than on providing management guidelines.

DETERMINING CERTIFICATION

Currently, the recertification time recommended for CMV drivers with diabetes and documented glucose control is 1 year. This is based on the assumption that the driver is under medical care with a treatment plan and that he/she is not currently experiencing any complications from the disease. Furthermore, insulin secretagogues (eg, sulfonylureas) can be used for glucose control as long as adverse effects (eg, hypoglycemia) do not interfere with safe driving. However, the FMCSA does not recommend certifying any driver who

• In the past 12 months has experienced a hypoglycemic reaction resulting in seizure; loss of consciousness; need of assistance from another person; or period of impaired cognitive function that occurred without warning.
• In the past 5 years has had recurring (≥ 2) disqualifying hypoglycemic reactions.
• Has received a formal diagnosis of peripheral neuropathy, loss of position, or pedal sensation.
• Has resting tachycardia or orthostatic hypotension.
• Has severe diabetic nephropathy requiring dialysis.
• Has severe nonproliferative or proliferative retinopathy.⁸

In drivers with new-onset hyperglycemia, it is appropriate for the medical examiner to refer the driver to his/her primary care provider for further testing (eg, A1C), determination of treatment, a copy of the diabetes medical standard for driving, and written opinion of the driver’s medical fitness for duty. Subsequently, the medical examiner can utilize this information from the primary care provider to determine certification for the driver. While there are no specific guidelines on the waiting period for certification, the driver should demonstrate glucose control with treatment that is adequate, effective, safe, and stable.⁷

Overall, while living with diabetes can be challenging, patients who demonstrate control of the disease can maintain their occupation as a CMV driver. The role of the medical examiner is to evaluate the driver’s risk to safely operate a CMV—in particular, considering the possibilities of a severe hypoglycemic episode or target organ dysfunction—whereas the clinician treating the driver’s diabetes is focused on minimizing the complications associated with hyperglycemia.

Continue to: As a reminder...

As a reminder, due to the progressive nature of the disease, recertification is recommended annually for drivers.⁷ Nevertheless, it is reassuring that the DOT has implemented safeguards designed to keep our citizens safe while travelling the highways and byways of the United States.

Given the patient’s elevated glucose, more information is needed to safely provide clearance for driving a CMV. The patient would be disqualified until he could provide documentation of glucose control. Therefore, this patient would benefit from a referral to his primary care provider to obtain a list of medications used to manage his disease, documentation of an A1C level <10% and no evidence of complications from diabetes, and a written opinion from the primary care provider indicating the driver is medically fit for duty. Accordingly, the primary care provider can ensure the patient demonstrates compliance in managing diabetes and can safely operate a CMV.

A 60-year-old man is sent by his new employer to your urgent care for a pre-employment Department of Transportation (DOT) physical to obtain clearance to drive a commercial motor vehicle. His medical history is significant for hypertension, for which he takes lisinopril. Otherwise, he is healthy, with normal vital signs. His physical exam is unremarkable, but the urine sample is notably positive for glucose. A fingerstick glucose test yields a measurement of 212 mg/dL. What is your next appropriate step to medically clear the patient to drive commercially?

Commercial motor vehicle (CMV) drivers are mandated by the Federal Motor Carrier Safety Administration (FMCSA) to receive a DOT physical examination by a licensed medical examiner. To qualify to perform the exam, physician assistants, advanced practice nurses, physicians, and chiropractors must complete an educational program and pass a written certification examination.¹ Subsequently, the examiners are placed on a national registry—the National Registry of Certified Medical Examiners—with the mission to improve highway safety by determining whether a CMV driver’s health meets standards and guidelines set by the FMCSA.²

Under current guidelines, a DOT physical exam for a healthy CMV driver is considered valid for a maximum of 24 months. However, some diseases and medications require frequent follow-up, which can shorten the length of time a driver can be medically cleared to operate a CMV. Furthermore, certain conditions can disqualify the driver from meeting the necessary standards required for medical certification.

This case presentation offers the opportunity to review the requirements for evaluation and certification of a CMV driver with new-onset hyperglycemia and, ultimately, diabetes. In the United States, types 1 and 2 diabetes are estimated to affect 30.3 million people.³ About 33% of CMV drivers have been diagnosed with diabetes, which is significant since research has demonstrated an increased risk for crashes in individuals with diabetes, due to potential incapacitation from hypoglycemia.^4-6

Thus, for practitioners and medical examiners, it is prudent to screen and manage diabetes in CMV drivers. In fact, over the past 15 years, federal regulations have stipulated that any driver with diabetes requiring insulin for control was disqualified from this type of work.⁷ This standard was developed in response to the increased risk for hypoglycemic reactions with the use of insulin. However, in September 2018, the FMCSA revised this regulation, permitting individuals with a stable insulin regimen and properly controlled diabetes to be qualified to operate a CMV. As a result, for drivers requiring insulin, the treating clinician must complete a standardized form within 45 days of the DOT exam, documenting management of the patient’s diabetes.⁸ For drivers with diabetes who do not require insulin, determinations are made on a case-by-case basis, with discernment of the driver’s ability to manage the disease and concurrently meet other standards for qualification.

HEALTH HISTORY AND EXAMINATION

Each CMV driver completes a standard medical history form that asks about specific medications, surgeries, or medical conditions, including diabetes or blood glucose problems. Subsequently, the driver and, ultimately, the medical examiner must expand upon and discuss every “yes” response to this questionnaire.

Regarding diabetes, the examiner should determine whether the disease is controlled by diet, pills, and/or insulin, with clarification of the doses, frequency, and prescriber. In addition, the examiner should review and document glucose control, blood glucose monitoring, history of hypoglycemic episodes, and episodes of fainting, dizziness, or loss of consciousness.⁷

Continue to: The physical exam should focus on...

The physical exam should focus on identifying signs of complications from diabetes, such as retinopathy, nephropathy, or peripheral neuropathy. At each certification visit, the examiner should assess the patient’s height and weight, BMI, vision, hearing, blood pressure, and heart rate, and perform urinalysis to screen for proteinuria or glycosuria. A fingerstick test to obtain a random blood glucose reading is often performed in a driver with glycosuria.

Likewise, the A1C level should be documented in every patient with new-onset or known diabetes, with the recommendation from the FMCSA that a level >10% is an indicator of poor glucose control.⁷ It is important to note that an A1C level up to 10% is not the glycemic target recognized by the American Diabetes Association and the American Association of Clinical Endocrinologists. The FMCSA is focused more on hypoglycemic concerns than on providing management guidelines.

DETERMINING CERTIFICATION

Currently, the recertification time recommended for CMV drivers with diabetes and documented glucose control is 1 year. This is based on the assumption that the driver is under medical care with a treatment plan and that he/she is not currently experiencing any complications from the disease. Furthermore, insulin secretagogues (eg, sulfonylureas) can be used for glucose control as long as adverse effects (eg, hypoglycemia) do not interfere with safe driving. However, the FMCSA does not recommend certifying any driver who

• In the past 12 months has experienced a hypoglycemic reaction resulting in seizure; loss of consciousness; need of assistance from another person; or period of impaired cognitive function that occurred without warning.
• In the past 5 years has had recurring (≥ 2) disqualifying hypoglycemic reactions.
• Has received a formal diagnosis of peripheral neuropathy, loss of position, or pedal sensation.
• Has resting tachycardia or orthostatic hypotension.
• Has severe diabetic nephropathy requiring dialysis.
• Has severe nonproliferative or proliferative retinopathy.⁸

In drivers with new-onset hyperglycemia, it is appropriate for the medical examiner to refer the driver to his/her primary care provider for further testing (eg, A1C), determination of treatment, a copy of the diabetes medical standard for driving, and written opinion of the driver’s medical fitness for duty. Subsequently, the medical examiner can utilize this information from the primary care provider to determine certification for the driver. While there are no specific guidelines on the waiting period for certification, the driver should demonstrate glucose control with treatment that is adequate, effective, safe, and stable.⁷

Overall, while living with diabetes can be challenging, patients who demonstrate control of the disease can maintain their occupation as a CMV driver. The role of the medical examiner is to evaluate the driver’s risk to safely operate a CMV—in particular, considering the possibilities of a severe hypoglycemic episode or target organ dysfunction—whereas the clinician treating the driver’s diabetes is focused on minimizing the complications associated with hyperglycemia.

Continue to: As a reminder...

As a reminder, due to the progressive nature of the disease, recertification is recommended annually for drivers.⁷ Nevertheless, it is reassuring that the DOT has implemented safeguards designed to keep our citizens safe while travelling the highways and byways of the United States.

Given the patient’s elevated glucose, more information is needed to safely provide clearance for driving a CMV. The patient would be disqualified until he could provide documentation of glucose control. Therefore, this patient would benefit from a referral to his primary care provider to obtain a list of medications used to manage his disease, documentation of an A1C level <10% and no evidence of complications from diabetes, and a written opinion from the primary care provider indicating the driver is medically fit for duty. Accordingly, the primary care provider can ensure the patient demonstrates compliance in managing diabetes and can safely operate a CMV.

A 60-year-old man is sent by his new employer to your urgent care for a pre-employment Department of Transportation (DOT) physical to obtain clearance to drive a commercial motor vehicle. His medical history is significant for hypertension, for which he takes lisinopril. Otherwise, he is healthy, with normal vital signs. His physical exam is unremarkable, but the urine sample is notably positive for glucose. A fingerstick glucose test yields a measurement of 212 mg/dL. What is your next appropriate step to medically clear the patient to drive commercially?

Commercial motor vehicle (CMV) drivers are mandated by the Federal Motor Carrier Safety Administration (FMCSA) to receive a DOT physical examination by a licensed medical examiner. To qualify to perform the exam, physician assistants, advanced practice nurses, physicians, and chiropractors must complete an educational program and pass a written certification examination.¹ Subsequently, the examiners are placed on a national registry—the National Registry of Certified Medical Examiners—with the mission to improve highway safety by determining whether a CMV driver’s health meets standards and guidelines set by the FMCSA.²

Under current guidelines, a DOT physical exam for a healthy CMV driver is considered valid for a maximum of 24 months. However, some diseases and medications require frequent follow-up, which can shorten the length of time a driver can be medically cleared to operate a CMV. Furthermore, certain conditions can disqualify the driver from meeting the necessary standards required for medical certification.

This case presentation offers the opportunity to review the requirements for evaluation and certification of a CMV driver with new-onset hyperglycemia and, ultimately, diabetes. In the United States, types 1 and 2 diabetes are estimated to affect 30.3 million people.³ About 33% of CMV drivers have been diagnosed with diabetes, which is significant since research has demonstrated an increased risk for crashes in individuals with diabetes, due to potential incapacitation from hypoglycemia.^4-6

Thus, for practitioners and medical examiners, it is prudent to screen and manage diabetes in CMV drivers. In fact, over the past 15 years, federal regulations have stipulated that any driver with diabetes requiring insulin for control was disqualified from this type of work.⁷ This standard was developed in response to the increased risk for hypoglycemic reactions with the use of insulin. However, in September 2018, the FMCSA revised this regulation, permitting individuals with a stable insulin regimen and properly controlled diabetes to be qualified to operate a CMV. As a result, for drivers requiring insulin, the treating clinician must complete a standardized form within 45 days of the DOT exam, documenting management of the patient’s diabetes.⁸ For drivers with diabetes who do not require insulin, determinations are made on a case-by-case basis, with discernment of the driver’s ability to manage the disease and concurrently meet other standards for qualification.

HEALTH HISTORY AND EXAMINATION

Each CMV driver completes a standard medical history form that asks about specific medications, surgeries, or medical conditions, including diabetes or blood glucose problems. Subsequently, the driver and, ultimately, the medical examiner must expand upon and discuss every “yes” response to this questionnaire.

Regarding diabetes, the examiner should determine whether the disease is controlled by diet, pills, and/or insulin, with clarification of the doses, frequency, and prescriber. In addition, the examiner should review and document glucose control, blood glucose monitoring, history of hypoglycemic episodes, and episodes of fainting, dizziness, or loss of consciousness.⁷

Continue to: The physical exam should focus on...

The physical exam should focus on identifying signs of complications from diabetes, such as retinopathy, nephropathy, or peripheral neuropathy. At each certification visit, the examiner should assess the patient’s height and weight, BMI, vision, hearing, blood pressure, and heart rate, and perform urinalysis to screen for proteinuria or glycosuria. A fingerstick test to obtain a random blood glucose reading is often performed in a driver with glycosuria.

Likewise, the A1C level should be documented in every patient with new-onset or known diabetes, with the recommendation from the FMCSA that a level >10% is an indicator of poor glucose control.⁷ It is important to note that an A1C level up to 10% is not the glycemic target recognized by the American Diabetes Association and the American Association of Clinical Endocrinologists. The FMCSA is focused more on hypoglycemic concerns than on providing management guidelines.

DETERMINING CERTIFICATION

Currently, the recertification time recommended for CMV drivers with diabetes and documented glucose control is 1 year. This is based on the assumption that the driver is under medical care with a treatment plan and that he/she is not currently experiencing any complications from the disease. Furthermore, insulin secretagogues (eg, sulfonylureas) can be used for glucose control as long as adverse effects (eg, hypoglycemia) do not interfere with safe driving. However, the FMCSA does not recommend certifying any driver who

• In the past 12 months has experienced a hypoglycemic reaction resulting in seizure; loss of consciousness; need of assistance from another person; or period of impaired cognitive function that occurred without warning.
• In the past 5 years has had recurring (≥ 2) disqualifying hypoglycemic reactions.
• Has received a formal diagnosis of peripheral neuropathy, loss of position, or pedal sensation.
• Has resting tachycardia or orthostatic hypotension.
• Has severe diabetic nephropathy requiring dialysis.
• Has severe nonproliferative or proliferative retinopathy.⁸

In drivers with new-onset hyperglycemia, it is appropriate for the medical examiner to refer the driver to his/her primary care provider for further testing (eg, A1C), determination of treatment, a copy of the diabetes medical standard for driving, and written opinion of the driver’s medical fitness for duty. Subsequently, the medical examiner can utilize this information from the primary care provider to determine certification for the driver. While there are no specific guidelines on the waiting period for certification, the driver should demonstrate glucose control with treatment that is adequate, effective, safe, and stable.⁷

Overall, while living with diabetes can be challenging, patients who demonstrate control of the disease can maintain their occupation as a CMV driver. The role of the medical examiner is to evaluate the driver’s risk to safely operate a CMV—in particular, considering the possibilities of a severe hypoglycemic episode or target organ dysfunction—whereas the clinician treating the driver’s diabetes is focused on minimizing the complications associated with hyperglycemia.

Continue to: As a reminder...

As a reminder, due to the progressive nature of the disease, recertification is recommended annually for drivers.⁷ Nevertheless, it is reassuring that the DOT has implemented safeguards designed to keep our citizens safe while travelling the highways and byways of the United States.

Given the patient’s elevated glucose, more information is needed to safely provide clearance for driving a CMV. The patient would be disqualified until he could provide documentation of glucose control. Therefore, this patient would benefit from a referral to his primary care provider to obtain a list of medications used to manage his disease, documentation of an A1C level <10% and no evidence of complications from diabetes, and a written opinion from the primary care provider indicating the driver is medically fit for duty. Accordingly, the primary care provider can ensure the patient demonstrates compliance in managing diabetes and can safely operate a CMV.

AGA established its Center for Gut Microbiome Research and Education in 2012 as the microbiome was just beginning to explode in the scientific literature. I have been privileged to chair the center’s scientific advisory board over the last 3 years. As I enter my final few months in this role, I wanted to look ahead to the issues we’ve prioritized for 2019 – many of which build on our accomplishments in 2018.

Diet and nutrition

More than ever before, clinicians and patients appreciate that what we eat can have an important impact on our digestive health and our gut microbes. Recognizing the need for a stronger evidence base, the NIH developed a nutrition research strategic plan, which AGA wrote in support of late last year. We will continue providing updates on the latest advances in the new year. In March, AGA will host the eighth annual Gut Microbiota for Health World Summit in Miami, Florida. This continues our long-standing collaboration with the European Society of Neurogastroenterology and Motility and the 2019 edition will focus on the interplay between what we eat and the microbes that live on and in us. Materials from the meeting will be made available through AGA’s educational platform, AGA University, later in the year.

Pro-, pre-, and synbiotics

Last fall, the center published its first two scientific statements on several important clinical studies on the gut microbiome. We collaborated with AGA’s GI Patient Center to issue patient-friendly resources on probiotics. Probiotics will continue to be a key topic for AGA guidance in 2019. In the spring issue of this newsletter, look for the first of a four-part educational series on prebiotics and digestive health. AGA also continues to develop a technical review and clinical guideline on the role of probiotics in the management of GI disease. A “first look” can be found on AGA’s clinical guidelines page under “Upcoming Guidelines.”

Microbiome-based diagnostics

As clinicians, we’ve experienced the growing popularity of direct-to-consumer genetic tests and questions from patients wanting to know what their results mean for existing or potential medical conditions. Inspired by discussions among clinicians within the AGA Community, scientific advisory board member Alexander Khoruts, MD, wrote a primer for clinicians on microbiome-based tests which was published recently; it was also disseminated through this newsletter and MedPage Today’s KevinMD.com. This issue will continue to be a challenge for researchers and clinicians as the research moves beyond correlation to causative relationships between our gut microbiome and human health and disease. The center will continue to provide guidance on this issue as the field evolves.

Microbiome-based therapeutics

The FMT National Registry announced the enrollment of its first patient this time last year. As it continues to recruit new sites, the registry’s steering committee (under the leadership of AGA members Colleen Kelly, MD, Loren Laine, MD, AGAF, and Gary Wu, MD, AGAF) will begin looking at data to develop an interim publication on lessons learned from the earliest-enrolled patients. FMT, of course, is the just the beginning of a revolution in microbiome-based therapeutics. As new pharmaceuticals targeting the gut microbiome advance in clinical trials, the center will help prepare health care professionals for what this will mean for their patients and their practices.

2019 promises to be another banner year in gut microbiome research. AGA and its Center for Gut Microbiome Research and Education will continue to provide evidence-based information and guidance on one of the most exciting emerging areas of science and medicine.


Dr. Hecht is professor of medicine and microbiology/immunology and chief, gastroenterology and nutrition, Loyola University Medical Center, and chair of the AGA Center for Gut Microbiome Research and Education scientific advisory board.
 

AGA established its Center for Gut Microbiome Research and Education in 2012 as the microbiome was just beginning to explode in the scientific literature. I have been privileged to chair the center’s scientific advisory board over the last 3 years. As I enter my final few months in this role, I wanted to look ahead to the issues we’ve prioritized for 2019 – many of which build on our accomplishments in 2018.

Diet and nutrition

More than ever before, clinicians and patients appreciate that what we eat can have an important impact on our digestive health and our gut microbes. Recognizing the need for a stronger evidence base, the NIH developed a nutrition research strategic plan, which AGA wrote in support of late last year. We will continue providing updates on the latest advances in the new year. In March, AGA will host the eighth annual Gut Microbiota for Health World Summit in Miami, Florida. This continues our long-standing collaboration with the European Society of Neurogastroenterology and Motility and the 2019 edition will focus on the interplay between what we eat and the microbes that live on and in us. Materials from the meeting will be made available through AGA’s educational platform, AGA University, later in the year.

Pro-, pre-, and synbiotics

Last fall, the center published its first two scientific statements on several important clinical studies on the gut microbiome. We collaborated with AGA’s GI Patient Center to issue patient-friendly resources on probiotics. Probiotics will continue to be a key topic for AGA guidance in 2019. In the spring issue of this newsletter, look for the first of a four-part educational series on prebiotics and digestive health. AGA also continues to develop a technical review and clinical guideline on the role of probiotics in the management of GI disease. A “first look” can be found on AGA’s clinical guidelines page under “Upcoming Guidelines.”

Microbiome-based diagnostics

As clinicians, we’ve experienced the growing popularity of direct-to-consumer genetic tests and questions from patients wanting to know what their results mean for existing or potential medical conditions. Inspired by discussions among clinicians within the AGA Community, scientific advisory board member Alexander Khoruts, MD, wrote a primer for clinicians on microbiome-based tests which was published recently; it was also disseminated through this newsletter and MedPage Today’s KevinMD.com. This issue will continue to be a challenge for researchers and clinicians as the research moves beyond correlation to causative relationships between our gut microbiome and human health and disease. The center will continue to provide guidance on this issue as the field evolves.

Microbiome-based therapeutics

The FMT National Registry announced the enrollment of its first patient this time last year. As it continues to recruit new sites, the registry’s steering committee (under the leadership of AGA members Colleen Kelly, MD, Loren Laine, MD, AGAF, and Gary Wu, MD, AGAF) will begin looking at data to develop an interim publication on lessons learned from the earliest-enrolled patients. FMT, of course, is the just the beginning of a revolution in microbiome-based therapeutics. As new pharmaceuticals targeting the gut microbiome advance in clinical trials, the center will help prepare health care professionals for what this will mean for their patients and their practices.

2019 promises to be another banner year in gut microbiome research. AGA and its Center for Gut Microbiome Research and Education will continue to provide evidence-based information and guidance on one of the most exciting emerging areas of science and medicine.


Dr. Hecht is professor of medicine and microbiology/immunology and chief, gastroenterology and nutrition, Loyola University Medical Center, and chair of the AGA Center for Gut Microbiome Research and Education scientific advisory board.
 

AGA established its Center for Gut Microbiome Research and Education in 2012 as the microbiome was just beginning to explode in the scientific literature. I have been privileged to chair the center’s scientific advisory board over the last 3 years. As I enter my final few months in this role, I wanted to look ahead to the issues we’ve prioritized for 2019 – many of which build on our accomplishments in 2018.

Diet and nutrition

More than ever before, clinicians and patients appreciate that what we eat can have an important impact on our digestive health and our gut microbes. Recognizing the need for a stronger evidence base, the NIH developed a nutrition research strategic plan, which AGA wrote in support of late last year. We will continue providing updates on the latest advances in the new year. In March, AGA will host the eighth annual Gut Microbiota for Health World Summit in Miami, Florida. This continues our long-standing collaboration with the European Society of Neurogastroenterology and Motility and the 2019 edition will focus on the interplay between what we eat and the microbes that live on and in us. Materials from the meeting will be made available through AGA’s educational platform, AGA University, later in the year.

Pro-, pre-, and synbiotics

Last fall, the center published its first two scientific statements on several important clinical studies on the gut microbiome. We collaborated with AGA’s GI Patient Center to issue patient-friendly resources on probiotics. Probiotics will continue to be a key topic for AGA guidance in 2019. In the spring issue of this newsletter, look for the first of a four-part educational series on prebiotics and digestive health. AGA also continues to develop a technical review and clinical guideline on the role of probiotics in the management of GI disease. A “first look” can be found on AGA’s clinical guidelines page under “Upcoming Guidelines.”

Microbiome-based diagnostics

As clinicians, we’ve experienced the growing popularity of direct-to-consumer genetic tests and questions from patients wanting to know what their results mean for existing or potential medical conditions. Inspired by discussions among clinicians within the AGA Community, scientific advisory board member Alexander Khoruts, MD, wrote a primer for clinicians on microbiome-based tests which was published recently; it was also disseminated through this newsletter and MedPage Today’s KevinMD.com. This issue will continue to be a challenge for researchers and clinicians as the research moves beyond correlation to causative relationships between our gut microbiome and human health and disease. The center will continue to provide guidance on this issue as the field evolves.

Microbiome-based therapeutics

The FMT National Registry announced the enrollment of its first patient this time last year. As it continues to recruit new sites, the registry’s steering committee (under the leadership of AGA members Colleen Kelly, MD, Loren Laine, MD, AGAF, and Gary Wu, MD, AGAF) will begin looking at data to develop an interim publication on lessons learned from the earliest-enrolled patients. FMT, of course, is the just the beginning of a revolution in microbiome-based therapeutics. As new pharmaceuticals targeting the gut microbiome advance in clinical trials, the center will help prepare health care professionals for what this will mean for their patients and their practices.

2019 promises to be another banner year in gut microbiome research. AGA and its Center for Gut Microbiome Research and Education will continue to provide evidence-based information and guidance on one of the most exciting emerging areas of science and medicine.


Dr. Hecht is professor of medicine and microbiology/immunology and chief, gastroenterology and nutrition, Loyola University Medical Center, and chair of the AGA Center for Gut Microbiome Research and Education scientific advisory board.
 

The Trump administration bars federal funds for clinics that provide abortion counseling or referrals. Physician PAC dollars support candidates who don’t back gun regulation. Consider obesity as a cardiovascular disease risk factor in children. And the final ‘Vision’ report addresses maintenance of certification woes.

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The Trump administration bars federal funds for clinics that provide abortion counseling or referrals. Physician PAC dollars support candidates who don’t back gun regulation. Consider obesity as a cardiovascular disease risk factor in children. And the final ‘Vision’ report addresses maintenance of certification woes.

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Apple Podcasts
Google Podcasts
Spotify

The Trump administration bars federal funds for clinics that provide abortion counseling or referrals. Physician PAC dollars support candidates who don’t back gun regulation. Consider obesity as a cardiovascular disease risk factor in children. And the final ‘Vision’ report addresses maintenance of certification woes.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify

SAN DIEGO – During resuscitation of patients with septic shock, a simple strategy of timing the refilling of peripheral capillaries trended toward better 28-day survival than using lactate level targeting, but missed statistical significance.

Jim Kling/MDedge News

Although the paper, published online in JAMA, concludes that normalization of capillary refill time cannot be recommended over targeting serum lactate levels, Glenn Hernández, MD, PhD, sounded more optimistic after presenting the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. “I think it’s good news to develop techniques that, even though they have this integrated variability, they can provide a signal that is also very close to the [underlying] physiology,” Dr. Hernández, who is a professor of intensive medicine at Pontifical Catholic University in Santiago, Chile. The Peripheral perfusion was also associated with lower mean Sequential Organ Failure Assessment (SOFA) Score at 72 hours.

The technique involves pressing a glass microscope slide to the ventral surface of the right index finger distal phalanx, increasing pressure and maintaining pressure for 10 seconds. After release, a chronometer assessed return of normal skin color, with refill times over 3 seconds considered abnormal. Clinicians applied the technique every 30 minutes during until normalization (every hour after that), compared with every 2 hours for the lactate arm of the study.

The ANDROMEDA-SHOCK randomized clinical trial was conducted at 28 hospitals in five countries (Argentina, Chile, Colombia, Ecuador, Uruguay). The trial did not demonstrate superiority of capillary refill, and it was not designed for noninferiority. It nevertheless seems unlikely that assessment of capillary refill is inferior to lactate levels, according an accompanying editorial by JAMA-associated editor Derek Angus, MD, who also is a professor of critical care medicine at the University of Pittsburgh. The simplicity of using a capillary refill could be particularly useful in resource-limited settings, since it can be accomplished visually.

It also a natural marker for resuscitation. The body slows fluid flow to peripheral tissues until vital organs are well perfused. Normal capillary refill time “is an indirect signal of reperfusion,” said Dr. Hernández.

The researchers are not calling for this technique to replace lactate measurements, noting that in many ways the techniques can be complementary, since lactate levels are a good indicator of the patient’s overall improvement. In any case, it would take more research to prove superiority of the capillary refill, and that’s not something Dr. Hernández is planning to undertake. The current study had no external funding and required about half of his time over a 2-year period. Getting the work done at all “was sort of a miracle. We would not repeat this,” he said.

The researchers randomized 416 patients with septic shock (mean age, 63 years; 53% of whom were women) to be managed by peripheral perfusion or lactate measurement. By day 28, 43.4% in the lactate group had died, compared with 34.9% in the peripheral perfusion group (hazard ratio, 0.75; P = .06). At 72 hours, the peripheral perfusion group had less organ dysfunction as measured by SOFA (mean, 5.6 vs. 6.6; P = .045). Six other secondary outcomes revealed no between-group differences.

The peripheral perfusion group received an average of 408 fewer mL of resuscitation fluids during the first 8 hours (P = .01).

That result fits with the greater responsiveness of peripheral perfusion measurements, and it’s relevant because some septic shock patients who are unresponsive to fluids often receive fluids anyway. “The general knowledge, though not correct, is that you treat lactate or blood pressure with fluids,” said coauthor Jan Bakker, MD, PhD, who is a professor at New York-Presbyterian Hospital Columbia University, and Erasmus University Rotterdam, the Netherlands.

After a series of observational studies suggested that warm, well-perfused patients were doing well, the idea was tested in a small interventional trial in which physicians were forbidden from giving fluids once patients were warm and well perfused. Patients did better than did those on standard of care. “We have said, if the patient is warm and well perfused, even if they are hypotensive, don’t give fluids, it won’t benefit them anymore. Give vasopressors or whatever, but don’t give fluids,” said Dr. Bakker.

The latest research also reinforced a signal from the earlier, smaller trial. “You get less organ failure if you use [fewer] fluids,” Dr. Bakker added.

The study received no external funding. Dr. Hernández and Dr. Bakker had no relevant financial disclosures. Dr. Angus received consulting fees from Ferring Pharmaceutical, Bristol-Myers Squibb, Bayer AG, and others outside the submitted work; he also has patents pending for compounds, compositions, and methods for treating sepsis and for proteomic biomarkers.

SOURCE: Hernández G et al. JAMA 2019 Feb 17. doi: 10.1001/jama.2019.0071.

SAN DIEGO – During resuscitation of patients with septic shock, a simple strategy of timing the refilling of peripheral capillaries trended toward better 28-day survival than using lactate level targeting, but missed statistical significance.

Jim Kling/MDedge News

Although the paper, published online in JAMA, concludes that normalization of capillary refill time cannot be recommended over targeting serum lactate levels, Glenn Hernández, MD, PhD, sounded more optimistic after presenting the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. “I think it’s good news to develop techniques that, even though they have this integrated variability, they can provide a signal that is also very close to the [underlying] physiology,” Dr. Hernández, who is a professor of intensive medicine at Pontifical Catholic University in Santiago, Chile. The Peripheral perfusion was also associated with lower mean Sequential Organ Failure Assessment (SOFA) Score at 72 hours.

The technique involves pressing a glass microscope slide to the ventral surface of the right index finger distal phalanx, increasing pressure and maintaining pressure for 10 seconds. After release, a chronometer assessed return of normal skin color, with refill times over 3 seconds considered abnormal. Clinicians applied the technique every 30 minutes during until normalization (every hour after that), compared with every 2 hours for the lactate arm of the study.

The ANDROMEDA-SHOCK randomized clinical trial was conducted at 28 hospitals in five countries (Argentina, Chile, Colombia, Ecuador, Uruguay). The trial did not demonstrate superiority of capillary refill, and it was not designed for noninferiority. It nevertheless seems unlikely that assessment of capillary refill is inferior to lactate levels, according an accompanying editorial by JAMA-associated editor Derek Angus, MD, who also is a professor of critical care medicine at the University of Pittsburgh. The simplicity of using a capillary refill could be particularly useful in resource-limited settings, since it can be accomplished visually.

It also a natural marker for resuscitation. The body slows fluid flow to peripheral tissues until vital organs are well perfused. Normal capillary refill time “is an indirect signal of reperfusion,” said Dr. Hernández.

The researchers are not calling for this technique to replace lactate measurements, noting that in many ways the techniques can be complementary, since lactate levels are a good indicator of the patient’s overall improvement. In any case, it would take more research to prove superiority of the capillary refill, and that’s not something Dr. Hernández is planning to undertake. The current study had no external funding and required about half of his time over a 2-year period. Getting the work done at all “was sort of a miracle. We would not repeat this,” he said.

The researchers randomized 416 patients with septic shock (mean age, 63 years; 53% of whom were women) to be managed by peripheral perfusion or lactate measurement. By day 28, 43.4% in the lactate group had died, compared with 34.9% in the peripheral perfusion group (hazard ratio, 0.75; P = .06). At 72 hours, the peripheral perfusion group had less organ dysfunction as measured by SOFA (mean, 5.6 vs. 6.6; P = .045). Six other secondary outcomes revealed no between-group differences.

The peripheral perfusion group received an average of 408 fewer mL of resuscitation fluids during the first 8 hours (P = .01).

That result fits with the greater responsiveness of peripheral perfusion measurements, and it’s relevant because some septic shock patients who are unresponsive to fluids often receive fluids anyway. “The general knowledge, though not correct, is that you treat lactate or blood pressure with fluids,” said coauthor Jan Bakker, MD, PhD, who is a professor at New York-Presbyterian Hospital Columbia University, and Erasmus University Rotterdam, the Netherlands.

After a series of observational studies suggested that warm, well-perfused patients were doing well, the idea was tested in a small interventional trial in which physicians were forbidden from giving fluids once patients were warm and well perfused. Patients did better than did those on standard of care. “We have said, if the patient is warm and well perfused, even if they are hypotensive, don’t give fluids, it won’t benefit them anymore. Give vasopressors or whatever, but don’t give fluids,” said Dr. Bakker.

The latest research also reinforced a signal from the earlier, smaller trial. “You get less organ failure if you use [fewer] fluids,” Dr. Bakker added.

The study received no external funding. Dr. Hernández and Dr. Bakker had no relevant financial disclosures. Dr. Angus received consulting fees from Ferring Pharmaceutical, Bristol-Myers Squibb, Bayer AG, and others outside the submitted work; he also has patents pending for compounds, compositions, and methods for treating sepsis and for proteomic biomarkers.

SOURCE: Hernández G et al. JAMA 2019 Feb 17. doi: 10.1001/jama.2019.0071.

SAN DIEGO – During resuscitation of patients with septic shock, a simple strategy of timing the refilling of peripheral capillaries trended toward better 28-day survival than using lactate level targeting, but missed statistical significance.

Jim Kling/MDedge News

Although the paper, published online in JAMA, concludes that normalization of capillary refill time cannot be recommended over targeting serum lactate levels, Glenn Hernández, MD, PhD, sounded more optimistic after presenting the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. “I think it’s good news to develop techniques that, even though they have this integrated variability, they can provide a signal that is also very close to the [underlying] physiology,” Dr. Hernández, who is a professor of intensive medicine at Pontifical Catholic University in Santiago, Chile. The Peripheral perfusion was also associated with lower mean Sequential Organ Failure Assessment (SOFA) Score at 72 hours.

The technique involves pressing a glass microscope slide to the ventral surface of the right index finger distal phalanx, increasing pressure and maintaining pressure for 10 seconds. After release, a chronometer assessed return of normal skin color, with refill times over 3 seconds considered abnormal. Clinicians applied the technique every 30 minutes during until normalization (every hour after that), compared with every 2 hours for the lactate arm of the study.

The ANDROMEDA-SHOCK randomized clinical trial was conducted at 28 hospitals in five countries (Argentina, Chile, Colombia, Ecuador, Uruguay). The trial did not demonstrate superiority of capillary refill, and it was not designed for noninferiority. It nevertheless seems unlikely that assessment of capillary refill is inferior to lactate levels, according an accompanying editorial by JAMA-associated editor Derek Angus, MD, who also is a professor of critical care medicine at the University of Pittsburgh. The simplicity of using a capillary refill could be particularly useful in resource-limited settings, since it can be accomplished visually.

It also a natural marker for resuscitation. The body slows fluid flow to peripheral tissues until vital organs are well perfused. Normal capillary refill time “is an indirect signal of reperfusion,” said Dr. Hernández.

The researchers are not calling for this technique to replace lactate measurements, noting that in many ways the techniques can be complementary, since lactate levels are a good indicator of the patient’s overall improvement. In any case, it would take more research to prove superiority of the capillary refill, and that’s not something Dr. Hernández is planning to undertake. The current study had no external funding and required about half of his time over a 2-year period. Getting the work done at all “was sort of a miracle. We would not repeat this,” he said.

The researchers randomized 416 patients with septic shock (mean age, 63 years; 53% of whom were women) to be managed by peripheral perfusion or lactate measurement. By day 28, 43.4% in the lactate group had died, compared with 34.9% in the peripheral perfusion group (hazard ratio, 0.75; P = .06). At 72 hours, the peripheral perfusion group had less organ dysfunction as measured by SOFA (mean, 5.6 vs. 6.6; P = .045). Six other secondary outcomes revealed no between-group differences.

The peripheral perfusion group received an average of 408 fewer mL of resuscitation fluids during the first 8 hours (P = .01).

That result fits with the greater responsiveness of peripheral perfusion measurements, and it’s relevant because some septic shock patients who are unresponsive to fluids often receive fluids anyway. “The general knowledge, though not correct, is that you treat lactate or blood pressure with fluids,” said coauthor Jan Bakker, MD, PhD, who is a professor at New York-Presbyterian Hospital Columbia University, and Erasmus University Rotterdam, the Netherlands.

After a series of observational studies suggested that warm, well-perfused patients were doing well, the idea was tested in a small interventional trial in which physicians were forbidden from giving fluids once patients were warm and well perfused. Patients did better than did those on standard of care. “We have said, if the patient is warm and well perfused, even if they are hypotensive, don’t give fluids, it won’t benefit them anymore. Give vasopressors or whatever, but don’t give fluids,” said Dr. Bakker.

The latest research also reinforced a signal from the earlier, smaller trial. “You get less organ failure if you use [fewer] fluids,” Dr. Bakker added.

The study received no external funding. Dr. Hernández and Dr. Bakker had no relevant financial disclosures. Dr. Angus received consulting fees from Ferring Pharmaceutical, Bristol-Myers Squibb, Bayer AG, and others outside the submitted work; he also has patents pending for compounds, compositions, and methods for treating sepsis and for proteomic biomarkers.

SOURCE: Hernández G et al. JAMA 2019 Feb 17. doi: 10.1001/jama.2019.0071.

SAN FRANCISCO – The estimated U.S. prevalence of sesame allergy appears to be at least 0.23% among both adults and children, roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.

The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.

“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.

An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.

Mitchel L. Zoler/MDedge News

[email protected]

SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.

SAN FRANCISCO – The estimated U.S. prevalence of sesame allergy appears to be at least 0.23% among both adults and children, roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.

The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.

“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.

An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.

Mitchel L. Zoler/MDedge News

[email protected]

SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.

SAN FRANCISCO – The estimated U.S. prevalence of sesame allergy appears to be at least 0.23% among both adults and children, roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.

The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.

“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.

An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.

Mitchel L. Zoler/MDedge News

[email protected]

SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.

Antidepressants could be the best adjunctive treatment for adult outpatients with schizophrenia who are taking a second-generation antipsychotic and need a change in medication, results of an observational study suggest. Patients who added antidepressants to their treatment had a lower risk of psychiatric hospitalization and emergency room visits than did those who tried an alternative antipsychotic, and those who took mood stabilizers and benzodiazepines were significantly more likely to die over 365 days.

Specifically, “the possibility that adjunctive use of gabapentin is associated with increased risk of death raises a serious concern,” wrote T. Scott Stroup, MD, MPH, of the department of psychiatry at Columbia University, New York, and his associates in JAMA Psychiatry.

Often, Dr. Stroup and his associates noted, second-generation antipsychotics often are insufficient to alleviate symptoms and leave patients with functional limitations. Still, there’s “little high-quality evidence” regarding the best treatments for schizophrenia, said Dr. Stroup, who is also affiliated with the New York State Psychiatric Institute, and his associates.

Using a Medicaid database, the researchers retrospectively tracked 81,921 outpatients with schizophrenia (aged 18-64 years; mean age, 41 years; 46% women) who were treated with a single antipsychotic from 2001-2010. Each patient added an antidepressant (31,117), a benzodiazepine (11,941), a mood stabilizer (12,849), or another second-generation antipsychotic (26,014).

The researchers examined treatment outcomes over a yearlong period after patients began their new treatment and compared the various groups to the reference group (those who began taking an additional antipsychotic medication).

Compared with the reference group, patients who took an antidepressant had a lower risk of psychiatric hospitalization (hazard ratio, 0.84; 95% confidence interval, 0.80-0.88), while the benzodiazepine group had a higher risk (HR, 1.08; 95% CI, 1.02-1.15), and the mood stabilizer group saw no major difference (HR, 0.98; 95% CI, 0.94-1.03). Similar results were found for the risk of psychiatric emergency department visits, compared with the reference group: The HR with the addition of an antidepressant was 0.92 (95% CI, 0.88-0.96), 1.12 with a benzodiazepine (95% CI, 1.07-1.19), and 0.99 with a mood stabilizer (95% CI, 0.94-1.04).

In regard to mortality, the researchers found that mood stabilizers and benzodiazepines stood apart on the risk front with HRs of 1.31 (95% CI, 1.04-1.66) and 1.22 (95% CI, 0.98-1.52), respectively. Among mood stabilizer use, Gabapentin accounted for 1,755 initiations (13.7%) and was associated with 45 deaths (28.0%), the researchers reported. “No other mood stabilizer appeared to be associated with a higher rate of death than the others.”

Dr. Stroup and his associates cited several limitations. One is that the results might not be generalizable because the investigators looked only at patients who were enrolled in the Medicaid program. Nevertheless, “improved pharmacologic treatment of schizophrenia and consequent reduced need for hospitalization and ED visits associated with more antidepressant and less benzodiazepine use would represent a significant benefit for individuals and for public health,” they wrote.

The study authors reported various relationships with drugmakers, including Auspex, Intra-Cellular Therapies, Eli Lilly, Bristol-Myers Squibb, and Merck. The study was funded by a Patient-Centered Outcomes Research Institute award.

SOURCE: Stroup TS et al. JAMA Psychiatry. 2019 Feb 20. doi: 10.1001/jamapsychiatry.2018.4489.

Antidepressants could be the best adjunctive treatment for adult outpatients with schizophrenia who are taking a second-generation antipsychotic and need a change in medication, results of an observational study suggest. Patients who added antidepressants to their treatment had a lower risk of psychiatric hospitalization and emergency room visits than did those who tried an alternative antipsychotic, and those who took mood stabilizers and benzodiazepines were significantly more likely to die over 365 days.

Specifically, “the possibility that adjunctive use of gabapentin is associated with increased risk of death raises a serious concern,” wrote T. Scott Stroup, MD, MPH, of the department of psychiatry at Columbia University, New York, and his associates in JAMA Psychiatry.

Often, Dr. Stroup and his associates noted, second-generation antipsychotics often are insufficient to alleviate symptoms and leave patients with functional limitations. Still, there’s “little high-quality evidence” regarding the best treatments for schizophrenia, said Dr. Stroup, who is also affiliated with the New York State Psychiatric Institute, and his associates.

Using a Medicaid database, the researchers retrospectively tracked 81,921 outpatients with schizophrenia (aged 18-64 years; mean age, 41 years; 46% women) who were treated with a single antipsychotic from 2001-2010. Each patient added an antidepressant (31,117), a benzodiazepine (11,941), a mood stabilizer (12,849), or another second-generation antipsychotic (26,014).

The researchers examined treatment outcomes over a yearlong period after patients began their new treatment and compared the various groups to the reference group (those who began taking an additional antipsychotic medication).

Compared with the reference group, patients who took an antidepressant had a lower risk of psychiatric hospitalization (hazard ratio, 0.84; 95% confidence interval, 0.80-0.88), while the benzodiazepine group had a higher risk (HR, 1.08; 95% CI, 1.02-1.15), and the mood stabilizer group saw no major difference (HR, 0.98; 95% CI, 0.94-1.03). Similar results were found for the risk of psychiatric emergency department visits, compared with the reference group: The HR with the addition of an antidepressant was 0.92 (95% CI, 0.88-0.96), 1.12 with a benzodiazepine (95% CI, 1.07-1.19), and 0.99 with a mood stabilizer (95% CI, 0.94-1.04).

In regard to mortality, the researchers found that mood stabilizers and benzodiazepines stood apart on the risk front with HRs of 1.31 (95% CI, 1.04-1.66) and 1.22 (95% CI, 0.98-1.52), respectively. Among mood stabilizer use, Gabapentin accounted for 1,755 initiations (13.7%) and was associated with 45 deaths (28.0%), the researchers reported. “No other mood stabilizer appeared to be associated with a higher rate of death than the others.”

Dr. Stroup and his associates cited several limitations. One is that the results might not be generalizable because the investigators looked only at patients who were enrolled in the Medicaid program. Nevertheless, “improved pharmacologic treatment of schizophrenia and consequent reduced need for hospitalization and ED visits associated with more antidepressant and less benzodiazepine use would represent a significant benefit for individuals and for public health,” they wrote.

The study authors reported various relationships with drugmakers, including Auspex, Intra-Cellular Therapies, Eli Lilly, Bristol-Myers Squibb, and Merck. The study was funded by a Patient-Centered Outcomes Research Institute award.

SOURCE: Stroup TS et al. JAMA Psychiatry. 2019 Feb 20. doi: 10.1001/jamapsychiatry.2018.4489.

Antidepressants could be the best adjunctive treatment for adult outpatients with schizophrenia who are taking a second-generation antipsychotic and need a change in medication, results of an observational study suggest. Patients who added antidepressants to their treatment had a lower risk of psychiatric hospitalization and emergency room visits than did those who tried an alternative antipsychotic, and those who took mood stabilizers and benzodiazepines were significantly more likely to die over 365 days.

Specifically, “the possibility that adjunctive use of gabapentin is associated with increased risk of death raises a serious concern,” wrote T. Scott Stroup, MD, MPH, of the department of psychiatry at Columbia University, New York, and his associates in JAMA Psychiatry.

Often, Dr. Stroup and his associates noted, second-generation antipsychotics often are insufficient to alleviate symptoms and leave patients with functional limitations. Still, there’s “little high-quality evidence” regarding the best treatments for schizophrenia, said Dr. Stroup, who is also affiliated with the New York State Psychiatric Institute, and his associates.

Using a Medicaid database, the researchers retrospectively tracked 81,921 outpatients with schizophrenia (aged 18-64 years; mean age, 41 years; 46% women) who were treated with a single antipsychotic from 2001-2010. Each patient added an antidepressant (31,117), a benzodiazepine (11,941), a mood stabilizer (12,849), or another second-generation antipsychotic (26,014).

The researchers examined treatment outcomes over a yearlong period after patients began their new treatment and compared the various groups to the reference group (those who began taking an additional antipsychotic medication).

Compared with the reference group, patients who took an antidepressant had a lower risk of psychiatric hospitalization (hazard ratio, 0.84; 95% confidence interval, 0.80-0.88), while the benzodiazepine group had a higher risk (HR, 1.08; 95% CI, 1.02-1.15), and the mood stabilizer group saw no major difference (HR, 0.98; 95% CI, 0.94-1.03). Similar results were found for the risk of psychiatric emergency department visits, compared with the reference group: The HR with the addition of an antidepressant was 0.92 (95% CI, 0.88-0.96), 1.12 with a benzodiazepine (95% CI, 1.07-1.19), and 0.99 with a mood stabilizer (95% CI, 0.94-1.04).

In regard to mortality, the researchers found that mood stabilizers and benzodiazepines stood apart on the risk front with HRs of 1.31 (95% CI, 1.04-1.66) and 1.22 (95% CI, 0.98-1.52), respectively. Among mood stabilizer use, Gabapentin accounted for 1,755 initiations (13.7%) and was associated with 45 deaths (28.0%), the researchers reported. “No other mood stabilizer appeared to be associated with a higher rate of death than the others.”

Dr. Stroup and his associates cited several limitations. One is that the results might not be generalizable because the investigators looked only at patients who were enrolled in the Medicaid program. Nevertheless, “improved pharmacologic treatment of schizophrenia and consequent reduced need for hospitalization and ED visits associated with more antidepressant and less benzodiazepine use would represent a significant benefit for individuals and for public health,” they wrote.

The study authors reported various relationships with drugmakers, including Auspex, Intra-Cellular Therapies, Eli Lilly, Bristol-Myers Squibb, and Merck. The study was funded by a Patient-Centered Outcomes Research Institute award.

SOURCE: Stroup TS et al. JAMA Psychiatry. 2019 Feb 20. doi: 10.1001/jamapsychiatry.2018.4489.

The correlation between parental nonmedical prescription opioid use and offspring use should be considered in targeted efforts to reduce adolescent use, reported Pamela C. Griesler, PhD, of Columbia University, New York, and her associates.

BackyardProduction/Thinkstock

Given the significant link between parental and adolescent smoking and adolescent nonmedical prescription opioid (NMPO) use, smoking also should be included in targeted interventions, they wrote in Pediatrics.

Dr. Griesler and her colleagues noted that there actually are three classes of factors influencing the association between parent and adolescent NMPO use: phenotypic heritability, parental role modeling, and parental socialization and other environmental influences.

In the first known study to explore the relationship of parent-adolescent NMPO use within a nationally representative sampling of parent-child dyads taken from the National Surveys on Drug Use and Health, Dr. Griesler and her colleagues examined the intergenerational association of lifetime NMPO use among 35,000 parent-adolescent dyads (21,200 mothers, 13,800 fathers). Of the 35,000 children aged 12-17 years included in the sample, 90% were biological, 8% were stepchildren, and 2% were adopted.

Given the absence of previous studies exploring the relationship between parent-adolescent NMPO use, Dr. Griesler and her associates used established findings for smoking and substance use to hypothesize that there would be stronger associations for mothers than fathers, daughters than sons, and for whites than African Americans.

The investigators posed three questions that formed the basis of their research: 1) What is the association between lifetime parental and child NMPO use? 2) What is the unique association between parental and child NMPO use, controlling for other factors? 3) Do parental/adolescent NMPO use associations differ by parent/child gender and race and/or ethnicity?

About 14% of parents reported ever using an NMPO; fathers (14%) had slightly higher rates of usage than mothers (13%), and white parents had higher rates of use (16%) than African American (10%) or Hispanic (9%) parents. Among adolescents, 9% reported ever having used an NMPO; this included similar rates for boys (9%) and girls (9%), as well as whites (9%), Hispanics (9%), and African Americans (8%). Use increased with age over time, from 4% among 12-year-olds to 15% among 17-year-olds.

SOURCE: Griesler PC et al. Pediatrics. 2019;143(3):e20182354.

The correlation between parental nonmedical prescription opioid use and offspring use should be considered in targeted efforts to reduce adolescent use, reported Pamela C. Griesler, PhD, of Columbia University, New York, and her associates.

BackyardProduction/Thinkstock

Given the significant link between parental and adolescent smoking and adolescent nonmedical prescription opioid (NMPO) use, smoking also should be included in targeted interventions, they wrote in Pediatrics.

Dr. Griesler and her colleagues noted that there actually are three classes of factors influencing the association between parent and adolescent NMPO use: phenotypic heritability, parental role modeling, and parental socialization and other environmental influences.

In the first known study to explore the relationship of parent-adolescent NMPO use within a nationally representative sampling of parent-child dyads taken from the National Surveys on Drug Use and Health, Dr. Griesler and her colleagues examined the intergenerational association of lifetime NMPO use among 35,000 parent-adolescent dyads (21,200 mothers, 13,800 fathers). Of the 35,000 children aged 12-17 years included in the sample, 90% were biological, 8% were stepchildren, and 2% were adopted.

Given the absence of previous studies exploring the relationship between parent-adolescent NMPO use, Dr. Griesler and her associates used established findings for smoking and substance use to hypothesize that there would be stronger associations for mothers than fathers, daughters than sons, and for whites than African Americans.

The investigators posed three questions that formed the basis of their research: 1) What is the association between lifetime parental and child NMPO use? 2) What is the unique association between parental and child NMPO use, controlling for other factors? 3) Do parental/adolescent NMPO use associations differ by parent/child gender and race and/or ethnicity?

About 14% of parents reported ever using an NMPO; fathers (14%) had slightly higher rates of usage than mothers (13%), and white parents had higher rates of use (16%) than African American (10%) or Hispanic (9%) parents. Among adolescents, 9% reported ever having used an NMPO; this included similar rates for boys (9%) and girls (9%), as well as whites (9%), Hispanics (9%), and African Americans (8%). Use increased with age over time, from 4% among 12-year-olds to 15% among 17-year-olds.

SOURCE: Griesler PC et al. Pediatrics. 2019;143(3):e20182354.

The correlation between parental nonmedical prescription opioid use and offspring use should be considered in targeted efforts to reduce adolescent use, reported Pamela C. Griesler, PhD, of Columbia University, New York, and her associates.

BackyardProduction/Thinkstock

Given the significant link between parental and adolescent smoking and adolescent nonmedical prescription opioid (NMPO) use, smoking also should be included in targeted interventions, they wrote in Pediatrics.

Dr. Griesler and her colleagues noted that there actually are three classes of factors influencing the association between parent and adolescent NMPO use: phenotypic heritability, parental role modeling, and parental socialization and other environmental influences.

In the first known study to explore the relationship of parent-adolescent NMPO use within a nationally representative sampling of parent-child dyads taken from the National Surveys on Drug Use and Health, Dr. Griesler and her colleagues examined the intergenerational association of lifetime NMPO use among 35,000 parent-adolescent dyads (21,200 mothers, 13,800 fathers). Of the 35,000 children aged 12-17 years included in the sample, 90% were biological, 8% were stepchildren, and 2% were adopted.

Given the absence of previous studies exploring the relationship between parent-adolescent NMPO use, Dr. Griesler and her associates used established findings for smoking and substance use to hypothesize that there would be stronger associations for mothers than fathers, daughters than sons, and for whites than African Americans.

The investigators posed three questions that formed the basis of their research: 1) What is the association between lifetime parental and child NMPO use? 2) What is the unique association between parental and child NMPO use, controlling for other factors? 3) Do parental/adolescent NMPO use associations differ by parent/child gender and race and/or ethnicity?

About 14% of parents reported ever using an NMPO; fathers (14%) had slightly higher rates of usage than mothers (13%), and white parents had higher rates of use (16%) than African American (10%) or Hispanic (9%) parents. Among adolescents, 9% reported ever having used an NMPO; this included similar rates for boys (9%) and girls (9%), as well as whites (9%), Hispanics (9%), and African Americans (8%). Use increased with age over time, from 4% among 12-year-olds to 15% among 17-year-olds.

SOURCE: Griesler PC et al. Pediatrics. 2019;143(3):e20182354.

The Food and Drug Administration has approved Orsiro, an ultrathin drug-eluting stent (DES), for the treatment of coronary artery disease.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval was based on 2-year results from BIOFLOW-V, an international, randomized trial in 1,344 patients with coronary artery disease who received either Orsiro or Xience, the current clinical standard. At 2 years, patients who received Orsiro had a 37% lower target lesion failure rate, a 47% lower ischemia-driven target lesion revascularization rate, and a 70% lower spontaneous MI rate. These results were published in the Journal of the American College of Cardiology and presented at the Transcatheter Cardiovascular Therapeutics annual meeting in November  2018.

Orsiro previously received CE marking in Europe in 2011 and has been used to treat more than 1 million patients. The device elutes sirolimus and is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, according to Biotronik’s press release.

“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation,” David Kandzari, MD, a cardiologist at Piedmont Heart Institute in Atlanta and principal U.S. investigator for BIOFLOW-V, said in the press release.

[email protected]

The Food and Drug Administration has approved Orsiro, an ultrathin drug-eluting stent (DES), for the treatment of coronary artery disease.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval was based on 2-year results from BIOFLOW-V, an international, randomized trial in 1,344 patients with coronary artery disease who received either Orsiro or Xience, the current clinical standard. At 2 years, patients who received Orsiro had a 37% lower target lesion failure rate, a 47% lower ischemia-driven target lesion revascularization rate, and a 70% lower spontaneous MI rate. These results were published in the Journal of the American College of Cardiology and presented at the Transcatheter Cardiovascular Therapeutics annual meeting in November  2018.

Orsiro previously received CE marking in Europe in 2011 and has been used to treat more than 1 million patients. The device elutes sirolimus and is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, according to Biotronik’s press release.

“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation,” David Kandzari, MD, a cardiologist at Piedmont Heart Institute in Atlanta and principal U.S. investigator for BIOFLOW-V, said in the press release.

[email protected]

The Food and Drug Administration has approved Orsiro, an ultrathin drug-eluting stent (DES), for the treatment of coronary artery disease.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval was based on 2-year results from BIOFLOW-V, an international, randomized trial in 1,344 patients with coronary artery disease who received either Orsiro or Xience, the current clinical standard. At 2 years, patients who received Orsiro had a 37% lower target lesion failure rate, a 47% lower ischemia-driven target lesion revascularization rate, and a 70% lower spontaneous MI rate. These results were published in the Journal of the American College of Cardiology and presented at the Transcatheter Cardiovascular Therapeutics annual meeting in November  2018.

Orsiro previously received CE marking in Europe in 2011 and has been used to treat more than 1 million patients. The device elutes sirolimus and is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, according to Biotronik’s press release.

“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation,” David Kandzari, MD, a cardiologist at Piedmont Heart Institute in Atlanta and principal U.S. investigator for BIOFLOW-V, said in the press release.

[email protected]

The Food and Drug Administration has approved Taiho’s trifluridine/tipiracil combination Lonsurf for adult patients with either gastric or gastroesophageal junction adenocarcinomas. Specifically, these patients will have been previously treated with at least two lines of chemotherapy that included fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, according to a statement from the company.

The approval was based on the TAGS trial (NCT02500043), which was a global, randomized, phase 3 study that evaluated Lonsurf plus best supportive care versus placebo plus best supportive care. The trial demonstrated prolonged overall survival with the drug combo, compared with that seen with placebo, and thereby met its primary and secondary endpoint. The safety profile seen in the trial was consistent with what’s previously been seen with the drug. Results from this trial were published in The Lancet Oncology.

Warnings and precautions for the drug combination include severe myelosuppression and embryo-fetal toxicity, as well as fatigue, nausea, diarrhea, infections, pyrexia, alopecia, and others. The full prescribing information can be found on the Taiho website.

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The Food and Drug Administration has approved Taiho’s trifluridine/tipiracil combination Lonsurf for adult patients with either gastric or gastroesophageal junction adenocarcinomas. Specifically, these patients will have been previously treated with at least two lines of chemotherapy that included fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, according to a statement from the company.

The approval was based on the TAGS trial (NCT02500043), which was a global, randomized, phase 3 study that evaluated Lonsurf plus best supportive care versus placebo plus best supportive care. The trial demonstrated prolonged overall survival with the drug combo, compared with that seen with placebo, and thereby met its primary and secondary endpoint. The safety profile seen in the trial was consistent with what’s previously been seen with the drug. Results from this trial were published in The Lancet Oncology.

Warnings and precautions for the drug combination include severe myelosuppression and embryo-fetal toxicity, as well as fatigue, nausea, diarrhea, infections, pyrexia, alopecia, and others. The full prescribing information can be found on the Taiho website.

[email protected]

The Food and Drug Administration has approved Taiho’s trifluridine/tipiracil combination Lonsurf for adult patients with either gastric or gastroesophageal junction adenocarcinomas. Specifically, these patients will have been previously treated with at least two lines of chemotherapy that included fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, according to a statement from the company.

The approval was based on the TAGS trial (NCT02500043), which was a global, randomized, phase 3 study that evaluated Lonsurf plus best supportive care versus placebo plus best supportive care. The trial demonstrated prolonged overall survival with the drug combo, compared with that seen with placebo, and thereby met its primary and secondary endpoint. The safety profile seen in the trial was consistent with what’s previously been seen with the drug. Results from this trial were published in The Lancet Oncology.

Warnings and precautions for the drug combination include severe myelosuppression and embryo-fetal toxicity, as well as fatigue, nausea, diarrhea, infections, pyrexia, alopecia, and others. The full prescribing information can be found on the Taiho website.

[email protected]