Building on the success of this year’s inaugural Crohn’s & Colitis Congress™, the Crohn’s & Colitis Foundation and the American Gastroenterological Association (AGA) are pleased to announce the second annual Crohn’s & Colitis Congress. Be sure to save the date: Feb. 7-9, 2019 at the Bellagio in Las Vegas.

The Crohn’s & Colitis Congress is the must-attend meeting for all inflammatory bowel disease (IBD) professionals. It offers a bold, multidisciplinary approach to learning in the IBD space as one care team. All health care professionals and research investigators interested in IBD are invited to attend.

By bringing all audiences together to learn from each other, the Congress embodies how IBD research and patient care needs to be approached – it is not “one-size-fits-all” and it requires collaboration from a variety of health practitioners.

By attending the Crohn’s& Colitis Congress, attendees will:

• Build a powerful network and share solutions with IBD thought leaders.

• Discover cutting-edge basic, translational and clinical research in the IBD space.

• Determine best practices at every stage of the patient’s disease journey.

• Explore new technologies and products from IBD-related exhibitors.

• Earn CME and MOC points.

• Improve skills and patient outcomes.

• Learn together as one multidisciplinary care team.

Get ready to expand your knowledge, network with IBD leaders, and be inspired. Stay tuned at www.crohnscolitiscongress.org for more details coming in later this spring.
 

Building on the success of this year’s inaugural Crohn’s & Colitis Congress™, the Crohn’s & Colitis Foundation and the American Gastroenterological Association (AGA) are pleased to announce the second annual Crohn’s & Colitis Congress. Be sure to save the date: Feb. 7-9, 2019 at the Bellagio in Las Vegas.

The Crohn’s & Colitis Congress is the must-attend meeting for all inflammatory bowel disease (IBD) professionals. It offers a bold, multidisciplinary approach to learning in the IBD space as one care team. All health care professionals and research investigators interested in IBD are invited to attend.

By bringing all audiences together to learn from each other, the Congress embodies how IBD research and patient care needs to be approached – it is not “one-size-fits-all” and it requires collaboration from a variety of health practitioners.

By attending the Crohn’s& Colitis Congress, attendees will:

• Build a powerful network and share solutions with IBD thought leaders.

• Discover cutting-edge basic, translational and clinical research in the IBD space.

• Determine best practices at every stage of the patient’s disease journey.

• Explore new technologies and products from IBD-related exhibitors.

• Earn CME and MOC points.

• Improve skills and patient outcomes.

• Learn together as one multidisciplinary care team.

Get ready to expand your knowledge, network with IBD leaders, and be inspired. Stay tuned at www.crohnscolitiscongress.org for more details coming in later this spring.
 

Building on the success of this year’s inaugural Crohn’s & Colitis Congress™, the Crohn’s & Colitis Foundation and the American Gastroenterological Association (AGA) are pleased to announce the second annual Crohn’s & Colitis Congress. Be sure to save the date: Feb. 7-9, 2019 at the Bellagio in Las Vegas.

The Crohn’s & Colitis Congress is the must-attend meeting for all inflammatory bowel disease (IBD) professionals. It offers a bold, multidisciplinary approach to learning in the IBD space as one care team. All health care professionals and research investigators interested in IBD are invited to attend.

By bringing all audiences together to learn from each other, the Congress embodies how IBD research and patient care needs to be approached – it is not “one-size-fits-all” and it requires collaboration from a variety of health practitioners.

By attending the Crohn’s& Colitis Congress, attendees will:

• Build a powerful network and share solutions with IBD thought leaders.

• Discover cutting-edge basic, translational and clinical research in the IBD space.

• Determine best practices at every stage of the patient’s disease journey.

• Explore new technologies and products from IBD-related exhibitors.

• Earn CME and MOC points.

• Improve skills and patient outcomes.

• Learn together as one multidisciplinary care team.

Get ready to expand your knowledge, network with IBD leaders, and be inspired. Stay tuned at www.crohnscolitiscongress.org for more details coming in later this spring.
 

A top priority for AGA this year is to call on the Centers for Medicare & Medicaid Services (CMS), other payors, and Congress to alleviate some of the regulatory burden that currently falls on physicians. Reevaluating prior authorization, step therapy, and Stark reform would allow physicians to devote more time and resources to provide high-quality care. A more comprehensive breakdown of the following key areas is available along with other top issues.

Prior authorization

• AGA urges payors to standardize prior authorization requirements and criteria and make them transparent and easily accessible. The services subject to prior authorization vary by payor, including CMS, as well as by plan type within a given payor. Physicians and physician practices are forced to comply with an increasing and unmanageable number of prior authorization requirements.

• AGA urges payors, including CMS, to develop and implement processes that allow for true “peer-to-peer” dialogues. Gastroenterologists seeking prior authorization for prescription drug or biologic therapy on behalf of a patient should be routed to a physician specialist in the same or similar discipline with expertise in the given condition to discuss the request.
 

Step therapy

• Step therapy, also known as “fail first,” occurs when an insurer requires patients to try and fail one or more lower-cost prescription drug or biologic therapies before covering the therapy originally prescribed by their health care provider.

• AGA urges insurers to reduce the burden of step therapy on physicians and physician practice. AGA supports The Restoring the Patient’s Voice Act (H.R. 2077), legislation introduced by Rep. Brad Wenstrup, R-Ohio, and Rep. Raul Ruiz, D-Calif., both physicians, that would provide a clear and timely appeals process when a patient has been subjected to step therapy.
 

Stark reform

• Stark self-referral laws prohibit physicians from referring patients to an entity in which they have a financial interest, which limits their ability to participate in many advanced alternative payment models (APMs). These prohibitions stifle care delivery innovation by inhibiting practices from incentivizing their physicians to deliver patient care more efficiently, because the practices cannot use resources from designated health services in rewarding or penalizing adherence to new clinical care pathways.

• AGA supports S. 2051/H.R. 4206, the Medicare Care Coordination Improvement Act, which would provide CMS with the regulatory authority to create exceptions under the Stark law for APMs and to remove barriers in the current law to the development and operation of such arrangements.
 

[email protected]

A top priority for AGA this year is to call on the Centers for Medicare & Medicaid Services (CMS), other payors, and Congress to alleviate some of the regulatory burden that currently falls on physicians. Reevaluating prior authorization, step therapy, and Stark reform would allow physicians to devote more time and resources to provide high-quality care. A more comprehensive breakdown of the following key areas is available along with other top issues.

Prior authorization

• AGA urges payors to standardize prior authorization requirements and criteria and make them transparent and easily accessible. The services subject to prior authorization vary by payor, including CMS, as well as by plan type within a given payor. Physicians and physician practices are forced to comply with an increasing and unmanageable number of prior authorization requirements.

• AGA urges payors, including CMS, to develop and implement processes that allow for true “peer-to-peer” dialogues. Gastroenterologists seeking prior authorization for prescription drug or biologic therapy on behalf of a patient should be routed to a physician specialist in the same or similar discipline with expertise in the given condition to discuss the request.
 

Step therapy

• Step therapy, also known as “fail first,” occurs when an insurer requires patients to try and fail one or more lower-cost prescription drug or biologic therapies before covering the therapy originally prescribed by their health care provider.

• AGA urges insurers to reduce the burden of step therapy on physicians and physician practice. AGA supports The Restoring the Patient’s Voice Act (H.R. 2077), legislation introduced by Rep. Brad Wenstrup, R-Ohio, and Rep. Raul Ruiz, D-Calif., both physicians, that would provide a clear and timely appeals process when a patient has been subjected to step therapy.
 

Stark reform

• Stark self-referral laws prohibit physicians from referring patients to an entity in which they have a financial interest, which limits their ability to participate in many advanced alternative payment models (APMs). These prohibitions stifle care delivery innovation by inhibiting practices from incentivizing their physicians to deliver patient care more efficiently, because the practices cannot use resources from designated health services in rewarding or penalizing adherence to new clinical care pathways.

• AGA supports S. 2051/H.R. 4206, the Medicare Care Coordination Improvement Act, which would provide CMS with the regulatory authority to create exceptions under the Stark law for APMs and to remove barriers in the current law to the development and operation of such arrangements.
 

[email protected]

A top priority for AGA this year is to call on the Centers for Medicare & Medicaid Services (CMS), other payors, and Congress to alleviate some of the regulatory burden that currently falls on physicians. Reevaluating prior authorization, step therapy, and Stark reform would allow physicians to devote more time and resources to provide high-quality care. A more comprehensive breakdown of the following key areas is available along with other top issues.

Prior authorization

• AGA urges payors to standardize prior authorization requirements and criteria and make them transparent and easily accessible. The services subject to prior authorization vary by payor, including CMS, as well as by plan type within a given payor. Physicians and physician practices are forced to comply with an increasing and unmanageable number of prior authorization requirements.

• AGA urges payors, including CMS, to develop and implement processes that allow for true “peer-to-peer” dialogues. Gastroenterologists seeking prior authorization for prescription drug or biologic therapy on behalf of a patient should be routed to a physician specialist in the same or similar discipline with expertise in the given condition to discuss the request.
 

Step therapy

• Step therapy, also known as “fail first,” occurs when an insurer requires patients to try and fail one or more lower-cost prescription drug or biologic therapies before covering the therapy originally prescribed by their health care provider.

• AGA urges insurers to reduce the burden of step therapy on physicians and physician practice. AGA supports The Restoring the Patient’s Voice Act (H.R. 2077), legislation introduced by Rep. Brad Wenstrup, R-Ohio, and Rep. Raul Ruiz, D-Calif., both physicians, that would provide a clear and timely appeals process when a patient has been subjected to step therapy.
 

Stark reform

• Stark self-referral laws prohibit physicians from referring patients to an entity in which they have a financial interest, which limits their ability to participate in many advanced alternative payment models (APMs). These prohibitions stifle care delivery innovation by inhibiting practices from incentivizing their physicians to deliver patient care more efficiently, because the practices cannot use resources from designated health services in rewarding or penalizing adherence to new clinical care pathways.

• AGA supports S. 2051/H.R. 4206, the Medicare Care Coordination Improvement Act, which would provide CMS with the regulatory authority to create exceptions under the Stark law for APMs and to remove barriers in the current law to the development and operation of such arrangements.
 

[email protected]

NEW ORLEANS – Gender inequities may pervade the medical profession, but a new generation of younger physicians – women and men – can help reshape medicine’s mindsets and workplaces.

At the annual meeting of the American College of Physicians, Sue Bornstein, MD, former chief of staff at Baylor University Medical Center in Dallas, and Darilyn Moyer, MD, CEO of the American College of Physicians, talked about the challenges to closing medicine’s gender-equity gaps, from structural bias to backlash. And they outlined strategies for women to broaden career opportunities and achieve fair payment – from mentoring and sponsoring, to leading change from the top of organizations.

The ACP published a position paper on achieving gender equity in the Annals of Internal Medicine.

Dr. Bornstein’s interview:

Dr. Moyer’s interview:

[email protected]

SOURCE: Ann Intern Med. 2018 Apr 17. doi: 10.7326/M17-3438.

NEW ORLEANS – Gender inequities may pervade the medical profession, but a new generation of younger physicians – women and men – can help reshape medicine’s mindsets and workplaces.

At the annual meeting of the American College of Physicians, Sue Bornstein, MD, former chief of staff at Baylor University Medical Center in Dallas, and Darilyn Moyer, MD, CEO of the American College of Physicians, talked about the challenges to closing medicine’s gender-equity gaps, from structural bias to backlash. And they outlined strategies for women to broaden career opportunities and achieve fair payment – from mentoring and sponsoring, to leading change from the top of organizations.

The ACP published a position paper on achieving gender equity in the Annals of Internal Medicine.

Dr. Bornstein’s interview:

Dr. Moyer’s interview:

[email protected]

SOURCE: Ann Intern Med. 2018 Apr 17. doi: 10.7326/M17-3438.

NEW ORLEANS – Gender inequities may pervade the medical profession, but a new generation of younger physicians – women and men – can help reshape medicine’s mindsets and workplaces.

At the annual meeting of the American College of Physicians, Sue Bornstein, MD, former chief of staff at Baylor University Medical Center in Dallas, and Darilyn Moyer, MD, CEO of the American College of Physicians, talked about the challenges to closing medicine’s gender-equity gaps, from structural bias to backlash. And they outlined strategies for women to broaden career opportunities and achieve fair payment – from mentoring and sponsoring, to leading change from the top of organizations.

The ACP published a position paper on achieving gender equity in the Annals of Internal Medicine.

Dr. Bornstein’s interview:

Dr. Moyer’s interview:

[email protected]

SOURCE: Ann Intern Med. 2018 Apr 17. doi: 10.7326/M17-3438.

Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of blood-brain barrier permeability in patients with relapsing-remitting multiple sclerosis may serve as an early marker of suboptimal treatment response to natalizumab or fingolimod, Danish researchers reported in a prospective, observational study.

The imaging method, when applied at baseline and at 3 months and 6 months after starting treatment with either drug in 35 patients, yielded a predictive threshold for determining if patients at 2 years of treatment would fail to meet criteria used for no evidence of disease activity (NEDA). The method is believed to work for natalizumab (Tysabri) and fingolimod (Gilenya) by measuring their effect on the passage of lymphocytes through the blood-brain barrier (BBB) because even though the two drugs have different mechanisms of action, “their final effect is the same, i.e., a reduction of the absolute number of lymphocytes trafficking across the BBB,” wrote Stig P. Cramer, MD, PhD, of the Rigshospitalet, Copenhagen, and his colleagues. The report was published in Annals of Neurology.

©Jana Blaková/Thinkstock

[email protected]

SOURCE: Cramer S et al. Ann Neurol. 2018 Mar 31. doi: 10.1002/ana.25219.

Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of blood-brain barrier permeability in patients with relapsing-remitting multiple sclerosis may serve as an early marker of suboptimal treatment response to natalizumab or fingolimod, Danish researchers reported in a prospective, observational study.

The imaging method, when applied at baseline and at 3 months and 6 months after starting treatment with either drug in 35 patients, yielded a predictive threshold for determining if patients at 2 years of treatment would fail to meet criteria used for no evidence of disease activity (NEDA). The method is believed to work for natalizumab (Tysabri) and fingolimod (Gilenya) by measuring their effect on the passage of lymphocytes through the blood-brain barrier (BBB) because even though the two drugs have different mechanisms of action, “their final effect is the same, i.e., a reduction of the absolute number of lymphocytes trafficking across the BBB,” wrote Stig P. Cramer, MD, PhD, of the Rigshospitalet, Copenhagen, and his colleagues. The report was published in Annals of Neurology.

©Jana Blaková/Thinkstock

[email protected]

SOURCE: Cramer S et al. Ann Neurol. 2018 Mar 31. doi: 10.1002/ana.25219.

Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of blood-brain barrier permeability in patients with relapsing-remitting multiple sclerosis may serve as an early marker of suboptimal treatment response to natalizumab or fingolimod, Danish researchers reported in a prospective, observational study.

The imaging method, when applied at baseline and at 3 months and 6 months after starting treatment with either drug in 35 patients, yielded a predictive threshold for determining if patients at 2 years of treatment would fail to meet criteria used for no evidence of disease activity (NEDA). The method is believed to work for natalizumab (Tysabri) and fingolimod (Gilenya) by measuring their effect on the passage of lymphocytes through the blood-brain barrier (BBB) because even though the two drugs have different mechanisms of action, “their final effect is the same, i.e., a reduction of the absolute number of lymphocytes trafficking across the BBB,” wrote Stig P. Cramer, MD, PhD, of the Rigshospitalet, Copenhagen, and his colleagues. The report was published in Annals of Neurology.

©Jana Blaková/Thinkstock

[email protected]

SOURCE: Cramer S et al. Ann Neurol. 2018 Mar 31. doi: 10.1002/ana.25219.

WASHINGTON – Therapy targeting early maladaptive schemas can reduce the severity of PTSD symptoms and improve the quality of life for patients, according to data presented at the annual conference of the Anxiety and Depression Association of America.

Change in early maladaptive schemas correlated with a 13%-20% variation in PTSD symptom severity among patients tested, which points to the efficacy of incorporating schema-based interventions in trauma-focused therapies, said Karina T. Loyo, of Marquette University, Milwaukee.

Early maladaptive schemas, broad worldviews that develop in childhood, can lead to unhealthy, pervasive expectations in adulthood that directly inhibit PTSD treatment, according to Ms. Loyo. “We can see with how early maladaptive schemas developed early on can influence how an individual interprets a traumatic event,” she said.

To test whether early maladaptive schemas can predict symptom reduction and life improvement beyond trauma-related cognitions, Ms. Loyo and her colleagues gave 120 PTSD patients an early maladaptive schemas questionnaire, a quality of life questionnaire, as well as the Posttraumatic Cognitions Inventory.

Using a regression model, investigators found the Posttraumatic Cognitions Inventory and schema questionnaire predicted quality of life fairly accurately. This was especially true of the schema questionnaire, which predicted 20% more variance in quality of life scores, Ms. Loyo said.

“This suggests that schema-focused therapy [SFT] is related to PTSD symptom severity reduction,” Ms. Loyo said. “This has clinical implications as far as how we integrate schema-based interventions in trauma-focused areas.”

These schema-based treatments can be used to change a patient’s thoughts on their disorder, as well as gather information. For example, a patient exhibiting the early maladaptive schema of mistrust from abuse might be suspicious of others based on childhood experiences of being used or taken advantage of by others. This can lead to alienation from others, which in turn, would affect the patient’s quality of life after their traumatic experience.

Using SFT, clinicians can talk through and identify the possible intentions of those in the patient’s life to reinforce the notion that the people in their life might be both imperfect yet trustworthy, Ms. Loyo said.

SFT can also be used to address childhood trauma that caused a patient’s development of early maladaptive schemas. This kind of work can build trust between the clinician and the patient – and make subsequent treatments more effective.

Unlike a typical trauma narrative, SFT focuses on increasing awareness of patients’ emotions before the trauma occurred and how they felt while addressing the moment the trauma occurred. In addition, SFT uses a slightly different form of imagery scripting in an effort to acknowledge patients’ pain and direct them in a more constructive direction to channel those emotions into rebuilding values such as trust.

Ms. Loyo reported no financial disclosures.

[email protected]

SOURCE: Loyo KT et al. ADAA 2018.

WASHINGTON – Therapy targeting early maladaptive schemas can reduce the severity of PTSD symptoms and improve the quality of life for patients, according to data presented at the annual conference of the Anxiety and Depression Association of America.

Change in early maladaptive schemas correlated with a 13%-20% variation in PTSD symptom severity among patients tested, which points to the efficacy of incorporating schema-based interventions in trauma-focused therapies, said Karina T. Loyo, of Marquette University, Milwaukee.

Early maladaptive schemas, broad worldviews that develop in childhood, can lead to unhealthy, pervasive expectations in adulthood that directly inhibit PTSD treatment, according to Ms. Loyo. “We can see with how early maladaptive schemas developed early on can influence how an individual interprets a traumatic event,” she said.

To test whether early maladaptive schemas can predict symptom reduction and life improvement beyond trauma-related cognitions, Ms. Loyo and her colleagues gave 120 PTSD patients an early maladaptive schemas questionnaire, a quality of life questionnaire, as well as the Posttraumatic Cognitions Inventory.

Using a regression model, investigators found the Posttraumatic Cognitions Inventory and schema questionnaire predicted quality of life fairly accurately. This was especially true of the schema questionnaire, which predicted 20% more variance in quality of life scores, Ms. Loyo said.

“This suggests that schema-focused therapy [SFT] is related to PTSD symptom severity reduction,” Ms. Loyo said. “This has clinical implications as far as how we integrate schema-based interventions in trauma-focused areas.”

These schema-based treatments can be used to change a patient’s thoughts on their disorder, as well as gather information. For example, a patient exhibiting the early maladaptive schema of mistrust from abuse might be suspicious of others based on childhood experiences of being used or taken advantage of by others. This can lead to alienation from others, which in turn, would affect the patient’s quality of life after their traumatic experience.

Using SFT, clinicians can talk through and identify the possible intentions of those in the patient’s life to reinforce the notion that the people in their life might be both imperfect yet trustworthy, Ms. Loyo said.

SFT can also be used to address childhood trauma that caused a patient’s development of early maladaptive schemas. This kind of work can build trust between the clinician and the patient – and make subsequent treatments more effective.

Unlike a typical trauma narrative, SFT focuses on increasing awareness of patients’ emotions before the trauma occurred and how they felt while addressing the moment the trauma occurred. In addition, SFT uses a slightly different form of imagery scripting in an effort to acknowledge patients’ pain and direct them in a more constructive direction to channel those emotions into rebuilding values such as trust.

Ms. Loyo reported no financial disclosures.

[email protected]

SOURCE: Loyo KT et al. ADAA 2018.

WASHINGTON – Therapy targeting early maladaptive schemas can reduce the severity of PTSD symptoms and improve the quality of life for patients, according to data presented at the annual conference of the Anxiety and Depression Association of America.

Change in early maladaptive schemas correlated with a 13%-20% variation in PTSD symptom severity among patients tested, which points to the efficacy of incorporating schema-based interventions in trauma-focused therapies, said Karina T. Loyo, of Marquette University, Milwaukee.

Early maladaptive schemas, broad worldviews that develop in childhood, can lead to unhealthy, pervasive expectations in adulthood that directly inhibit PTSD treatment, according to Ms. Loyo. “We can see with how early maladaptive schemas developed early on can influence how an individual interprets a traumatic event,” she said.

To test whether early maladaptive schemas can predict symptom reduction and life improvement beyond trauma-related cognitions, Ms. Loyo and her colleagues gave 120 PTSD patients an early maladaptive schemas questionnaire, a quality of life questionnaire, as well as the Posttraumatic Cognitions Inventory.

Using a regression model, investigators found the Posttraumatic Cognitions Inventory and schema questionnaire predicted quality of life fairly accurately. This was especially true of the schema questionnaire, which predicted 20% more variance in quality of life scores, Ms. Loyo said.

“This suggests that schema-focused therapy [SFT] is related to PTSD symptom severity reduction,” Ms. Loyo said. “This has clinical implications as far as how we integrate schema-based interventions in trauma-focused areas.”

These schema-based treatments can be used to change a patient’s thoughts on their disorder, as well as gather information. For example, a patient exhibiting the early maladaptive schema of mistrust from abuse might be suspicious of others based on childhood experiences of being used or taken advantage of by others. This can lead to alienation from others, which in turn, would affect the patient’s quality of life after their traumatic experience.

Using SFT, clinicians can talk through and identify the possible intentions of those in the patient’s life to reinforce the notion that the people in their life might be both imperfect yet trustworthy, Ms. Loyo said.

SFT can also be used to address childhood trauma that caused a patient’s development of early maladaptive schemas. This kind of work can build trust between the clinician and the patient – and make subsequent treatments more effective.

Unlike a typical trauma narrative, SFT focuses on increasing awareness of patients’ emotions before the trauma occurred and how they felt while addressing the moment the trauma occurred. In addition, SFT uses a slightly different form of imagery scripting in an effort to acknowledge patients’ pain and direct them in a more constructive direction to channel those emotions into rebuilding values such as trust.

Ms. Loyo reported no financial disclosures.

[email protected]

SOURCE: Loyo KT et al. ADAA 2018.

Who’s going to negotiate your contract: you or a professional? Lawyer Scott Roman – at a recent AGA Regional Practice Skills Workshop – explained that answering this question early on can help ensure you maximize your contract benefits. His advice for any negotiation is keep to the following in mind:

• Prepare, prepare, prepare. Employers know when you’re winging it.
•  Gain leverage. The more offers you have, the more leverage.
•  Give yourself adequate time to negotiate.
•  Establish your objectives and anticipate objectives of the employer.
•  Determine the best case, worst case, and most likely scenario before you start negotiating.
•  Try to define nonnegotiable issues.
•  Try to get something each time you give something.
•  Don’t negotiate against yourself.
•  Keep cool and remember that these are people you may have to work with.
•  Be flexible.

View the full presentation (login required), which also covers hot topics in negotiating your contract – more than 1-year base salary, bonuses, student loan repayment.

Visit www.gastro.org/education to see all on-demand education designed specifically for trainees and early career GIs.

Who’s going to negotiate your contract: you or a professional? Lawyer Scott Roman – at a recent AGA Regional Practice Skills Workshop – explained that answering this question early on can help ensure you maximize your contract benefits. His advice for any negotiation is keep to the following in mind:

• Prepare, prepare, prepare. Employers know when you’re winging it.
•  Gain leverage. The more offers you have, the more leverage.
•  Give yourself adequate time to negotiate.
•  Establish your objectives and anticipate objectives of the employer.
•  Determine the best case, worst case, and most likely scenario before you start negotiating.
•  Try to define nonnegotiable issues.
•  Try to get something each time you give something.
•  Don’t negotiate against yourself.
•  Keep cool and remember that these are people you may have to work with.
•  Be flexible.

View the full presentation (login required), which also covers hot topics in negotiating your contract – more than 1-year base salary, bonuses, student loan repayment.

Visit www.gastro.org/education to see all on-demand education designed specifically for trainees and early career GIs.

Who’s going to negotiate your contract: you or a professional? Lawyer Scott Roman – at a recent AGA Regional Practice Skills Workshop – explained that answering this question early on can help ensure you maximize your contract benefits. His advice for any negotiation is keep to the following in mind:

• Prepare, prepare, prepare. Employers know when you’re winging it.
•  Gain leverage. The more offers you have, the more leverage.
•  Give yourself adequate time to negotiate.
•  Establish your objectives and anticipate objectives of the employer.
•  Determine the best case, worst case, and most likely scenario before you start negotiating.
•  Try to define nonnegotiable issues.
•  Try to get something each time you give something.
•  Don’t negotiate against yourself.
•  Keep cool and remember that these are people you may have to work with.
•  Be flexible.

View the full presentation (login required), which also covers hot topics in negotiating your contract – more than 1-year base salary, bonuses, student loan repayment.

Visit www.gastro.org/education to see all on-demand education designed specifically for trainees and early career GIs.

New Orleans – An effective and well-tolerated, evidence-based strategy for managing statin-associated muscle complaints is to rechallenge with the same statin, Douglas S. Paauw, MD, said at the annual meeting of the American College of Physicians.

That being said, it must be recognized that statin-associated muscle symptoms remain an enigma. This was underscored in a recent study by investigators at Hartford (Conn.) Hospital, which suggested a need to reassess the whole concept of statin-associated muscle symptoms, according to Dr. Paauw, professor of medicine at the University of Washington, Seattle.

First things first

Before embarking on same-statin rechallenge, several things should first be done. Step 1 is to check the patient’s thyroid-stimulating hormone, creatine kinase, and serum vitamin D levels. Step 2 is to look for possible explanatory drug interactions, with verapamil and diltiazem being particularly common offenders in statin users.

If a patient with statin-associated muscle symptoms has a low serum vitamin D level, Dr. Paauw will give high-dose supplemental vitamin D. This strategy is supported by a University of Cincinnati prospective study of 146 patients with intolerable muscle symptoms on two or more statins, all of whom had a serum vitamin D below 32 ng/mL. They were placed on long-term vitamin D₂ at 50,000-100,000 units per week and rechallenged with a statin. At 2 years of follow-up while still on supplemental vitamin D, 91% of patients had a normal serum vitamin D, and 95% of these previously statin-intolerant patients were on statin therapy without muscle complaints (N Am J Med Sci. 2015 Mar;7[3]:86-93).

Hypothyroidism increases statin toxicity. “I can’t overstate how important it is to check the thyroid-stimulating hormone to see if we’re dealing with something really simple,” Dr. Paauw said, “because trust me, treating hypothyroidism is much easier than treating statin-associated muscle symptoms.”

It has long been known that fibrates increase the risk of statin toxicity. Much less well recognized is that not all fibrates are the same in this regard: The risk is 15 times greater with gemfibrozil than with fenofibrate. The risk is also higher with verapamil or diltiazem than with nifedipine or amlodipine. Other important causes of drug interactions that increase statin toxicity include amiodarone, azole antifungals, protease inhibitors, erythromycin, and clarithromycin, but not azithromycin.

“Simvastatin and lovastatin are probably the worst as far as drug interactions,” Dr. Paauw cautioned. “They’re cheap, they’ve been generic for a long, long time, and a lot of times insurance companies want to move people to them. I try to move patients away from those two, because they are the dirtiest of the statins as far as side effects and drug interactions.”

When a drug interaction simply cannot be avoided, it’s best to have patients take the drugs 12 hours apart so peak levels don’t overlap, he added.

Same-statin rechallenge

If the checks of TSH, vitamin D, and possible drug interactions don’t turn up anything that needs fixing, it makes sense to launch same-statin rechallenge.

This management strategy was greenlighted by Canadian investigators in a retrospective study of 118 patients who presented to a tertiary lipid clinic with a history of muscle-related symptoms on at least two different statins.

At a median follow-up of 17 months, 71% of rechallenged patients were tolerating the same statin, compared with 53% of those who were switched to a different statin and 57% who were switched to ezetimibe or another nonstatin LDL-lowering drug. Moreover, 50% of patients in the same-statin rechallenge group achieved their target LDL, compared with only 15% switched to nonstatin therapy (Can J Cardiol. 2017 May;33[5]:666-73).

“I like this study; it helps a lot,” Dr. Paauw noted. “I think it’s worthwhile the first time they have muscle pain to get them off the statin and see if they feel better, so you become convinced that the statin may have had something to do with it. Then tell the patient, ‘Let’s just give it another try.’ ”
 

Alternative strategies

In the event of recurrent symptoms after same-statin rechallenge, it’s reasonable to switch to extended-release fluvastatin at 80 mg/day or low-dose rosuvastatin daily. Only if the patient remains symptomatic after trials of a couple of other statins does Dr. Paauw recommend turning to 5 mg of rosuvastatin twice weekly as a last resort.

Twice-weekly rosuvastatin is a popular treatment strategy in patients with intolerable muscle complaints on daily statin therapy. In a study of 40 such patients, twice-weekly rosuvastatin proved to be tolerated by 80% of them (Am J Cardiol. 2008 Jun 15;101[12]:1747-8). But the long-term effectiveness remains unknown.

“I think this is a really good option for our very statin-intolerant patients when nothing else works,” Dr. Paauw explained. “My only concern about this is we have no outcome data. Is twice-weekly rosuvastatin going to help reduce MI risk, especially if we give it for secondary prevention, as well as a daily statin? We know from this study that twice-weekly rosuvastatin can lower the lipids, but we also believe statins do more than just lower lipids. So, daily statin therapy is preferential.”

What about giving coenzyme Q₁₀? It makes sense mechanistically: Coenzyme Q₁₀ is an antioxidant, ubiquinone, and patients with statin-associated muscle symptoms are ubiquinone depleted.

But while oral coenzyme Q₁₀ is a popular OTC treatment for statin-associated muscle complaints, it’s not supported by any good evidence. A meta-analysis of six randomized trials totaling 302 participants found coenzyme Q₁₀ had no impact on symptoms (Mayo Clin Proc. 2015;90[1]:24-34).

In Dr. Paauw’s view, however, those trials didn’t address the proper question.

“The studies that have been done aren’t the right study,“ he said. “The study that needs to be done is for prevention: Do patients who start a statin and coenzyme Q₁₀ at the same time stay on the statin and feel better?”

He reported having no financial conflicts of interest regarding his presentation.

[email protected]

New Orleans – An effective and well-tolerated, evidence-based strategy for managing statin-associated muscle complaints is to rechallenge with the same statin, Douglas S. Paauw, MD, said at the annual meeting of the American College of Physicians.

That being said, it must be recognized that statin-associated muscle symptoms remain an enigma. This was underscored in a recent study by investigators at Hartford (Conn.) Hospital, which suggested a need to reassess the whole concept of statin-associated muscle symptoms, according to Dr. Paauw, professor of medicine at the University of Washington, Seattle.

First things first

Before embarking on same-statin rechallenge, several things should first be done. Step 1 is to check the patient’s thyroid-stimulating hormone, creatine kinase, and serum vitamin D levels. Step 2 is to look for possible explanatory drug interactions, with verapamil and diltiazem being particularly common offenders in statin users.

If a patient with statin-associated muscle symptoms has a low serum vitamin D level, Dr. Paauw will give high-dose supplemental vitamin D. This strategy is supported by a University of Cincinnati prospective study of 146 patients with intolerable muscle symptoms on two or more statins, all of whom had a serum vitamin D below 32 ng/mL. They were placed on long-term vitamin D₂ at 50,000-100,000 units per week and rechallenged with a statin. At 2 years of follow-up while still on supplemental vitamin D, 91% of patients had a normal serum vitamin D, and 95% of these previously statin-intolerant patients were on statin therapy without muscle complaints (N Am J Med Sci. 2015 Mar;7[3]:86-93).

Hypothyroidism increases statin toxicity. “I can’t overstate how important it is to check the thyroid-stimulating hormone to see if we’re dealing with something really simple,” Dr. Paauw said, “because trust me, treating hypothyroidism is much easier than treating statin-associated muscle symptoms.”

It has long been known that fibrates increase the risk of statin toxicity. Much less well recognized is that not all fibrates are the same in this regard: The risk is 15 times greater with gemfibrozil than with fenofibrate. The risk is also higher with verapamil or diltiazem than with nifedipine or amlodipine. Other important causes of drug interactions that increase statin toxicity include amiodarone, azole antifungals, protease inhibitors, erythromycin, and clarithromycin, but not azithromycin.

“Simvastatin and lovastatin are probably the worst as far as drug interactions,” Dr. Paauw cautioned. “They’re cheap, they’ve been generic for a long, long time, and a lot of times insurance companies want to move people to them. I try to move patients away from those two, because they are the dirtiest of the statins as far as side effects and drug interactions.”

When a drug interaction simply cannot be avoided, it’s best to have patients take the drugs 12 hours apart so peak levels don’t overlap, he added.

Same-statin rechallenge

If the checks of TSH, vitamin D, and possible drug interactions don’t turn up anything that needs fixing, it makes sense to launch same-statin rechallenge.

This management strategy was greenlighted by Canadian investigators in a retrospective study of 118 patients who presented to a tertiary lipid clinic with a history of muscle-related symptoms on at least two different statins.

At a median follow-up of 17 months, 71% of rechallenged patients were tolerating the same statin, compared with 53% of those who were switched to a different statin and 57% who were switched to ezetimibe or another nonstatin LDL-lowering drug. Moreover, 50% of patients in the same-statin rechallenge group achieved their target LDL, compared with only 15% switched to nonstatin therapy (Can J Cardiol. 2017 May;33[5]:666-73).

“I like this study; it helps a lot,” Dr. Paauw noted. “I think it’s worthwhile the first time they have muscle pain to get them off the statin and see if they feel better, so you become convinced that the statin may have had something to do with it. Then tell the patient, ‘Let’s just give it another try.’ ”
 

Alternative strategies

In the event of recurrent symptoms after same-statin rechallenge, it’s reasonable to switch to extended-release fluvastatin at 80 mg/day or low-dose rosuvastatin daily. Only if the patient remains symptomatic after trials of a couple of other statins does Dr. Paauw recommend turning to 5 mg of rosuvastatin twice weekly as a last resort.

Twice-weekly rosuvastatin is a popular treatment strategy in patients with intolerable muscle complaints on daily statin therapy. In a study of 40 such patients, twice-weekly rosuvastatin proved to be tolerated by 80% of them (Am J Cardiol. 2008 Jun 15;101[12]:1747-8). But the long-term effectiveness remains unknown.

“I think this is a really good option for our very statin-intolerant patients when nothing else works,” Dr. Paauw explained. “My only concern about this is we have no outcome data. Is twice-weekly rosuvastatin going to help reduce MI risk, especially if we give it for secondary prevention, as well as a daily statin? We know from this study that twice-weekly rosuvastatin can lower the lipids, but we also believe statins do more than just lower lipids. So, daily statin therapy is preferential.”

What about giving coenzyme Q₁₀? It makes sense mechanistically: Coenzyme Q₁₀ is an antioxidant, ubiquinone, and patients with statin-associated muscle symptoms are ubiquinone depleted.

But while oral coenzyme Q₁₀ is a popular OTC treatment for statin-associated muscle complaints, it’s not supported by any good evidence. A meta-analysis of six randomized trials totaling 302 participants found coenzyme Q₁₀ had no impact on symptoms (Mayo Clin Proc. 2015;90[1]:24-34).

In Dr. Paauw’s view, however, those trials didn’t address the proper question.

“The studies that have been done aren’t the right study,“ he said. “The study that needs to be done is for prevention: Do patients who start a statin and coenzyme Q₁₀ at the same time stay on the statin and feel better?”

He reported having no financial conflicts of interest regarding his presentation.

[email protected]

New Orleans – An effective and well-tolerated, evidence-based strategy for managing statin-associated muscle complaints is to rechallenge with the same statin, Douglas S. Paauw, MD, said at the annual meeting of the American College of Physicians.

That being said, it must be recognized that statin-associated muscle symptoms remain an enigma. This was underscored in a recent study by investigators at Hartford (Conn.) Hospital, which suggested a need to reassess the whole concept of statin-associated muscle symptoms, according to Dr. Paauw, professor of medicine at the University of Washington, Seattle.

First things first

Before embarking on same-statin rechallenge, several things should first be done. Step 1 is to check the patient’s thyroid-stimulating hormone, creatine kinase, and serum vitamin D levels. Step 2 is to look for possible explanatory drug interactions, with verapamil and diltiazem being particularly common offenders in statin users.

If a patient with statin-associated muscle symptoms has a low serum vitamin D level, Dr. Paauw will give high-dose supplemental vitamin D. This strategy is supported by a University of Cincinnati prospective study of 146 patients with intolerable muscle symptoms on two or more statins, all of whom had a serum vitamin D below 32 ng/mL. They were placed on long-term vitamin D₂ at 50,000-100,000 units per week and rechallenged with a statin. At 2 years of follow-up while still on supplemental vitamin D, 91% of patients had a normal serum vitamin D, and 95% of these previously statin-intolerant patients were on statin therapy without muscle complaints (N Am J Med Sci. 2015 Mar;7[3]:86-93).

Hypothyroidism increases statin toxicity. “I can’t overstate how important it is to check the thyroid-stimulating hormone to see if we’re dealing with something really simple,” Dr. Paauw said, “because trust me, treating hypothyroidism is much easier than treating statin-associated muscle symptoms.”

It has long been known that fibrates increase the risk of statin toxicity. Much less well recognized is that not all fibrates are the same in this regard: The risk is 15 times greater with gemfibrozil than with fenofibrate. The risk is also higher with verapamil or diltiazem than with nifedipine or amlodipine. Other important causes of drug interactions that increase statin toxicity include amiodarone, azole antifungals, protease inhibitors, erythromycin, and clarithromycin, but not azithromycin.

“Simvastatin and lovastatin are probably the worst as far as drug interactions,” Dr. Paauw cautioned. “They’re cheap, they’ve been generic for a long, long time, and a lot of times insurance companies want to move people to them. I try to move patients away from those two, because they are the dirtiest of the statins as far as side effects and drug interactions.”

When a drug interaction simply cannot be avoided, it’s best to have patients take the drugs 12 hours apart so peak levels don’t overlap, he added.

Same-statin rechallenge

If the checks of TSH, vitamin D, and possible drug interactions don’t turn up anything that needs fixing, it makes sense to launch same-statin rechallenge.

This management strategy was greenlighted by Canadian investigators in a retrospective study of 118 patients who presented to a tertiary lipid clinic with a history of muscle-related symptoms on at least two different statins.

At a median follow-up of 17 months, 71% of rechallenged patients were tolerating the same statin, compared with 53% of those who were switched to a different statin and 57% who were switched to ezetimibe or another nonstatin LDL-lowering drug. Moreover, 50% of patients in the same-statin rechallenge group achieved their target LDL, compared with only 15% switched to nonstatin therapy (Can J Cardiol. 2017 May;33[5]:666-73).

“I like this study; it helps a lot,” Dr. Paauw noted. “I think it’s worthwhile the first time they have muscle pain to get them off the statin and see if they feel better, so you become convinced that the statin may have had something to do with it. Then tell the patient, ‘Let’s just give it another try.’ ”
 

Alternative strategies

In the event of recurrent symptoms after same-statin rechallenge, it’s reasonable to switch to extended-release fluvastatin at 80 mg/day or low-dose rosuvastatin daily. Only if the patient remains symptomatic after trials of a couple of other statins does Dr. Paauw recommend turning to 5 mg of rosuvastatin twice weekly as a last resort.

Twice-weekly rosuvastatin is a popular treatment strategy in patients with intolerable muscle complaints on daily statin therapy. In a study of 40 such patients, twice-weekly rosuvastatin proved to be tolerated by 80% of them (Am J Cardiol. 2008 Jun 15;101[12]:1747-8). But the long-term effectiveness remains unknown.

“I think this is a really good option for our very statin-intolerant patients when nothing else works,” Dr. Paauw explained. “My only concern about this is we have no outcome data. Is twice-weekly rosuvastatin going to help reduce MI risk, especially if we give it for secondary prevention, as well as a daily statin? We know from this study that twice-weekly rosuvastatin can lower the lipids, but we also believe statins do more than just lower lipids. So, daily statin therapy is preferential.”

What about giving coenzyme Q₁₀? It makes sense mechanistically: Coenzyme Q₁₀ is an antioxidant, ubiquinone, and patients with statin-associated muscle symptoms are ubiquinone depleted.

But while oral coenzyme Q₁₀ is a popular OTC treatment for statin-associated muscle complaints, it’s not supported by any good evidence. A meta-analysis of six randomized trials totaling 302 participants found coenzyme Q₁₀ had no impact on symptoms (Mayo Clin Proc. 2015;90[1]:24-34).

In Dr. Paauw’s view, however, those trials didn’t address the proper question.

“The studies that have been done aren’t the right study,“ he said. “The study that needs to be done is for prevention: Do patients who start a statin and coenzyme Q₁₀ at the same time stay on the statin and feel better?”

He reported having no financial conflicts of interest regarding his presentation.

[email protected]

Triple therapy for chronic obstructive pulmonary disease (COPD) achieved reductions in moderate to severe exacerbations when compared with two kinds of dual therapy, in a study published online in the New England Journal of Medicine.

The trial compared the outcomes of COPD patients using an inhaled therapy comprising a corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) with the outcomes of similar patients taking one of two other therapy combinations – a corticosteroid and a LABA, or a LABA and a LAMA. This trial – Informing the Pathway of COPD Treatment (IMPACT) – included 10,355 patients with symptomatic COPD in 37 countries, according to David A. Lipson, MD, and his colleagues (N Engl J Med. 2018 Apr 18. doi: 10.1056/NEJMoa1713901).

copyright designer491/Thinkstock

After 1 year, the rate of moderate to severe COPD exacerbations in the triple-therapy group was 0.91 per year, compared with 1.07 in the fluticasone furoate–vilanterol group and 1.21 in the vilanterol-umeclidinium group. This translated to a 15% reduction with triple therapy compared with fluticasone furoate–vilanterol and a 25% reduction compared with vilanterol-umeclidinium (P less than .001 for both).

When the analysis was limited to severe exacerbations alone, the difference was significant only between the triple therapy, which GSK is marketing as Trelegy Ellipta, and the vilanterol-umeclidinium dual therapy.

Dr. Lipson, of GSK and the University of Pennsylvania, and his coauthors noted that their finding of a greater benefit with the glucocorticoid-containing dual-therapy compared with the LABA-LAMA vilanterol-umeclidinium combination contradicted the findings of the earlier FLAME trial. This was likely due to differences in patient populations and design, as all patients in the FLAME trial had a 1-month run-in treatment with the bronchodilator tiotropium, the researchers explained.

“Therefore any patients who would require an inhaled glucocorticoid may have had an increase in exacerbations and a decrease in lung function during the run-in period and would have been forced to leave the trial,” they wrote.

Patients with higher eosinophil levels seemed to do even better with triple therapy. In those with eosinophil levels of 150 cells per microliter or above, the annual rate of moderate to severe exacerbations was 0.95 with triple therapy, 1.08 with fluticasone furoate–vilanterol, and 1.39 with vilanterol-umeclidinium.

Triple therapy also was associated with a significantly longer time to first event and greater improvements in quality of life, compared with the dual therapies.

Overall, the adverse event profile of triple therapy was similar to that of dual therapy. Contrasting that finding were differences in the incidences of physician-diagnosed pneumonia between the treatment groups. Physician-diagnosed pneumonia was 53% higher among patients who received fluticasone furoate – either in dual or triple therapy combinations. Eight percent of patients in the triple therapy group experienced pneumonia, compared with 7% of patients in the fluticasone furoate–vilanterol group and 5% in the vilanterol-umeclidinium group.

All-cause mortality was significantly lower in patients who received the inhaled glucocorticoid, although the authors said this finding was “fragile” and needed further investigation.

The rate of discontinuation or withdrawal from the trial was 6% for the triple therapy group, 8% for the fluticasone furoate–vilanterol group, and 9% for the vilanterol-umeclidinium group. The rates of serious adverse events in each group were 22%, 21%, and 23%, respectively.

At trial entry, 38% of patients were already receiving triple therapy and 29% were taking an inhaled glucocorticoid. The authors noted that any patients taking an inhaled glucocorticoid who were randomized to the vilanterol-umeclidinium group would have had to abruptly stop taking their inhaled glucocorticoids.

“It is unknown whether the abrupt discontinuation of inhaled glucocorticoids would have contributed to our finding of a lower rate of exacerbations in the inhaled glucocorticoid groups than in the LAMA-LABA group,” they wrote.

Fernando Martinez, MD, chief of the division of pulmonary and critical care medicine at New York–Presbyterian Hospital/Weill Cornell Medical Center, said the study advanced the understanding of COPD management by addressing some key evidence gaps, in a statement issued by GSK.

“By comparing various combinations of effective medications in the same device the study clarifies which type of patient gains greatest benefit from each class of medicine,” Dr Martinez said in the statement. “As many patients experience frequent exacerbations or ‘flare ups,’ which can often result in hospitalization, these data will be highly relevant to patients and clinicians as they consider the optimal treatment.”

The study was funded by GSK, which manufactures Trelegy Ellipta triple therapy for COPD. Eight authors were employees of GSK and two were on advisory boards for the company. Seven authors declared funding from a range of pharmaceutical companies including GSK. One author had no conflicts of interest to declare.

SOURCE: Lipson D et al. N Engl J Med. 2018 Apr 18. doi: 10.1056/NEJMoa1713901.

Triple therapy for chronic obstructive pulmonary disease (COPD) achieved reductions in moderate to severe exacerbations when compared with two kinds of dual therapy, in a study published online in the New England Journal of Medicine.

The trial compared the outcomes of COPD patients using an inhaled therapy comprising a corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) with the outcomes of similar patients taking one of two other therapy combinations – a corticosteroid and a LABA, or a LABA and a LAMA. This trial – Informing the Pathway of COPD Treatment (IMPACT) – included 10,355 patients with symptomatic COPD in 37 countries, according to David A. Lipson, MD, and his colleagues (N Engl J Med. 2018 Apr 18. doi: 10.1056/NEJMoa1713901).

copyright designer491/Thinkstock

After 1 year, the rate of moderate to severe COPD exacerbations in the triple-therapy group was 0.91 per year, compared with 1.07 in the fluticasone furoate–vilanterol group and 1.21 in the vilanterol-umeclidinium group. This translated to a 15% reduction with triple therapy compared with fluticasone furoate–vilanterol and a 25% reduction compared with vilanterol-umeclidinium (P less than .001 for both).

When the analysis was limited to severe exacerbations alone, the difference was significant only between the triple therapy, which GSK is marketing as Trelegy Ellipta, and the vilanterol-umeclidinium dual therapy.

Dr. Lipson, of GSK and the University of Pennsylvania, and his coauthors noted that their finding of a greater benefit with the glucocorticoid-containing dual-therapy compared with the LABA-LAMA vilanterol-umeclidinium combination contradicted the findings of the earlier FLAME trial. This was likely due to differences in patient populations and design, as all patients in the FLAME trial had a 1-month run-in treatment with the bronchodilator tiotropium, the researchers explained.

“Therefore any patients who would require an inhaled glucocorticoid may have had an increase in exacerbations and a decrease in lung function during the run-in period and would have been forced to leave the trial,” they wrote.

Patients with higher eosinophil levels seemed to do even better with triple therapy. In those with eosinophil levels of 150 cells per microliter or above, the annual rate of moderate to severe exacerbations was 0.95 with triple therapy, 1.08 with fluticasone furoate–vilanterol, and 1.39 with vilanterol-umeclidinium.

Triple therapy also was associated with a significantly longer time to first event and greater improvements in quality of life, compared with the dual therapies.

Overall, the adverse event profile of triple therapy was similar to that of dual therapy. Contrasting that finding were differences in the incidences of physician-diagnosed pneumonia between the treatment groups. Physician-diagnosed pneumonia was 53% higher among patients who received fluticasone furoate – either in dual or triple therapy combinations. Eight percent of patients in the triple therapy group experienced pneumonia, compared with 7% of patients in the fluticasone furoate–vilanterol group and 5% in the vilanterol-umeclidinium group.

All-cause mortality was significantly lower in patients who received the inhaled glucocorticoid, although the authors said this finding was “fragile” and needed further investigation.

The rate of discontinuation or withdrawal from the trial was 6% for the triple therapy group, 8% for the fluticasone furoate–vilanterol group, and 9% for the vilanterol-umeclidinium group. The rates of serious adverse events in each group were 22%, 21%, and 23%, respectively.

At trial entry, 38% of patients were already receiving triple therapy and 29% were taking an inhaled glucocorticoid. The authors noted that any patients taking an inhaled glucocorticoid who were randomized to the vilanterol-umeclidinium group would have had to abruptly stop taking their inhaled glucocorticoids.

“It is unknown whether the abrupt discontinuation of inhaled glucocorticoids would have contributed to our finding of a lower rate of exacerbations in the inhaled glucocorticoid groups than in the LAMA-LABA group,” they wrote.

Fernando Martinez, MD, chief of the division of pulmonary and critical care medicine at New York–Presbyterian Hospital/Weill Cornell Medical Center, said the study advanced the understanding of COPD management by addressing some key evidence gaps, in a statement issued by GSK.

“By comparing various combinations of effective medications in the same device the study clarifies which type of patient gains greatest benefit from each class of medicine,” Dr Martinez said in the statement. “As many patients experience frequent exacerbations or ‘flare ups,’ which can often result in hospitalization, these data will be highly relevant to patients and clinicians as they consider the optimal treatment.”

The study was funded by GSK, which manufactures Trelegy Ellipta triple therapy for COPD. Eight authors were employees of GSK and two were on advisory boards for the company. Seven authors declared funding from a range of pharmaceutical companies including GSK. One author had no conflicts of interest to declare.

SOURCE: Lipson D et al. N Engl J Med. 2018 Apr 18. doi: 10.1056/NEJMoa1713901.

Triple therapy for chronic obstructive pulmonary disease (COPD) achieved reductions in moderate to severe exacerbations when compared with two kinds of dual therapy, in a study published online in the New England Journal of Medicine.

The trial compared the outcomes of COPD patients using an inhaled therapy comprising a corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) with the outcomes of similar patients taking one of two other therapy combinations – a corticosteroid and a LABA, or a LABA and a LAMA. This trial – Informing the Pathway of COPD Treatment (IMPACT) – included 10,355 patients with symptomatic COPD in 37 countries, according to David A. Lipson, MD, and his colleagues (N Engl J Med. 2018 Apr 18. doi: 10.1056/NEJMoa1713901).

copyright designer491/Thinkstock

After 1 year, the rate of moderate to severe COPD exacerbations in the triple-therapy group was 0.91 per year, compared with 1.07 in the fluticasone furoate–vilanterol group and 1.21 in the vilanterol-umeclidinium group. This translated to a 15% reduction with triple therapy compared with fluticasone furoate–vilanterol and a 25% reduction compared with vilanterol-umeclidinium (P less than .001 for both).

When the analysis was limited to severe exacerbations alone, the difference was significant only between the triple therapy, which GSK is marketing as Trelegy Ellipta, and the vilanterol-umeclidinium dual therapy.

Dr. Lipson, of GSK and the University of Pennsylvania, and his coauthors noted that their finding of a greater benefit with the glucocorticoid-containing dual-therapy compared with the LABA-LAMA vilanterol-umeclidinium combination contradicted the findings of the earlier FLAME trial. This was likely due to differences in patient populations and design, as all patients in the FLAME trial had a 1-month run-in treatment with the bronchodilator tiotropium, the researchers explained.

“Therefore any patients who would require an inhaled glucocorticoid may have had an increase in exacerbations and a decrease in lung function during the run-in period and would have been forced to leave the trial,” they wrote.

Patients with higher eosinophil levels seemed to do even better with triple therapy. In those with eosinophil levels of 150 cells per microliter or above, the annual rate of moderate to severe exacerbations was 0.95 with triple therapy, 1.08 with fluticasone furoate–vilanterol, and 1.39 with vilanterol-umeclidinium.

Triple therapy also was associated with a significantly longer time to first event and greater improvements in quality of life, compared with the dual therapies.

Overall, the adverse event profile of triple therapy was similar to that of dual therapy. Contrasting that finding were differences in the incidences of physician-diagnosed pneumonia between the treatment groups. Physician-diagnosed pneumonia was 53% higher among patients who received fluticasone furoate – either in dual or triple therapy combinations. Eight percent of patients in the triple therapy group experienced pneumonia, compared with 7% of patients in the fluticasone furoate–vilanterol group and 5% in the vilanterol-umeclidinium group.

All-cause mortality was significantly lower in patients who received the inhaled glucocorticoid, although the authors said this finding was “fragile” and needed further investigation.

The rate of discontinuation or withdrawal from the trial was 6% for the triple therapy group, 8% for the fluticasone furoate–vilanterol group, and 9% for the vilanterol-umeclidinium group. The rates of serious adverse events in each group were 22%, 21%, and 23%, respectively.

At trial entry, 38% of patients were already receiving triple therapy and 29% were taking an inhaled glucocorticoid. The authors noted that any patients taking an inhaled glucocorticoid who were randomized to the vilanterol-umeclidinium group would have had to abruptly stop taking their inhaled glucocorticoids.

“It is unknown whether the abrupt discontinuation of inhaled glucocorticoids would have contributed to our finding of a lower rate of exacerbations in the inhaled glucocorticoid groups than in the LAMA-LABA group,” they wrote.

Fernando Martinez, MD, chief of the division of pulmonary and critical care medicine at New York–Presbyterian Hospital/Weill Cornell Medical Center, said the study advanced the understanding of COPD management by addressing some key evidence gaps, in a statement issued by GSK.

“By comparing various combinations of effective medications in the same device the study clarifies which type of patient gains greatest benefit from each class of medicine,” Dr Martinez said in the statement. “As many patients experience frequent exacerbations or ‘flare ups,’ which can often result in hospitalization, these data will be highly relevant to patients and clinicians as they consider the optimal treatment.”

The study was funded by GSK, which manufactures Trelegy Ellipta triple therapy for COPD. Eight authors were employees of GSK and two were on advisory boards for the company. Seven authors declared funding from a range of pharmaceutical companies including GSK. One author had no conflicts of interest to declare.

SOURCE: Lipson D et al. N Engl J Med. 2018 Apr 18. doi: 10.1056/NEJMoa1713901.

NEW ORLEANS – What happens outside the exam room often plays a crucial, and crucially overlooked, role in how well or poorly patients respond to medical therapy.

Social determinants – from the bus ride to a clinic to fitting medication compliance into a three-job work day – are at the center of a new push by the American College of Physicians to improve patient care and awaken physicians to the nonmedical factors that frustrate treatment and fuel outcomes failures.

When it comes to patients’ health, American College of Physicians President Jack Ende, MD, says it’s often ZIP code, not gene code, that can make all the difference.

At the annual meeting of the American College of Physicians, Dr. Ende of the University of Pennsylvania, Philadelphia; Sarah Candler, MD, of Baylor College of Medicine, Houston; and Karen DeSalvo, MD, of the University of Texas, Austin, outlined how physicians can look beyond biology and into patients’ social environments, and they shared resources physicians can use to counter social determinants that harm health.

The ACP published a position paper on social determinants of health in the Annals of Internal Medicine.

Dr. Candler's interview:

Dr. DeSalvo's interview:

Dr. Ende's interview:

[email protected]

SOURCE: Ann Intern Med. 2018 Apr 17;168(8):577-8.

NEW ORLEANS – What happens outside the exam room often plays a crucial, and crucially overlooked, role in how well or poorly patients respond to medical therapy.

Social determinants – from the bus ride to a clinic to fitting medication compliance into a three-job work day – are at the center of a new push by the American College of Physicians to improve patient care and awaken physicians to the nonmedical factors that frustrate treatment and fuel outcomes failures.

When it comes to patients’ health, American College of Physicians President Jack Ende, MD, says it’s often ZIP code, not gene code, that can make all the difference.

At the annual meeting of the American College of Physicians, Dr. Ende of the University of Pennsylvania, Philadelphia; Sarah Candler, MD, of Baylor College of Medicine, Houston; and Karen DeSalvo, MD, of the University of Texas, Austin, outlined how physicians can look beyond biology and into patients’ social environments, and they shared resources physicians can use to counter social determinants that harm health.

The ACP published a position paper on social determinants of health in the Annals of Internal Medicine.

Dr. Candler's interview:

Dr. DeSalvo's interview:

Dr. Ende's interview:

[email protected]

SOURCE: Ann Intern Med. 2018 Apr 17;168(8):577-8.

NEW ORLEANS – What happens outside the exam room often plays a crucial, and crucially overlooked, role in how well or poorly patients respond to medical therapy.

Social determinants – from the bus ride to a clinic to fitting medication compliance into a three-job work day – are at the center of a new push by the American College of Physicians to improve patient care and awaken physicians to the nonmedical factors that frustrate treatment and fuel outcomes failures.

When it comes to patients’ health, American College of Physicians President Jack Ende, MD, says it’s often ZIP code, not gene code, that can make all the difference.

At the annual meeting of the American College of Physicians, Dr. Ende of the University of Pennsylvania, Philadelphia; Sarah Candler, MD, of Baylor College of Medicine, Houston; and Karen DeSalvo, MD, of the University of Texas, Austin, outlined how physicians can look beyond biology and into patients’ social environments, and they shared resources physicians can use to counter social determinants that harm health.

The ACP published a position paper on social determinants of health in the Annals of Internal Medicine.

Dr. Candler's interview:

Dr. DeSalvo's interview:

Dr. Ende's interview:

[email protected]

SOURCE: Ann Intern Med. 2018 Apr 17;168(8):577-8.

A call to push pause on a Medicare payment program, it’s been a busy week at the FDA, ambulatory blood pressure measures outperform the office, and are fast food swamps to blame for more type 1 diabetes?

Listen to the MDedge Daily News podcast for all the details on today’s top news.

A call to push pause on a Medicare payment program, it’s been a busy week at the FDA, ambulatory blood pressure measures outperform the office, and are fast food swamps to blame for more type 1 diabetes?

Listen to the MDedge Daily News podcast for all the details on today’s top news.

A call to push pause on a Medicare payment program, it’s been a busy week at the FDA, ambulatory blood pressure measures outperform the office, and are fast food swamps to blame for more type 1 diabetes?

Listen to the MDedge Daily News podcast for all the details on today’s top news.