Quality improvement (QI) is essential to the advancement of medicine. QI differs from research as it focuses on already proven knowledge and aims to make quick, sustainable change in local health care systems. Community hospitals may not have organized quality improvement initiatives and often rely on individual hospitalists to be their champions.

Although there are resources for quality improvement projects, initiating a project can seem daunting to a hospitalist. Our aim is to equip the community hospitalist with basic skills to initiate their own successful project. We present our “Top 10” tips to review.



1. Start small: Many quality improvement ideas include grandiose changes that require a large buy-in or worse, more money. When starting a QI project, you need to consider low-cost, high-impact projects. Even the smallest projects can make considerable change. Focus on ideas that require only one or two improvement cycles to implement. Understand your hospital culture, flow, and processes, and then pick a project that is reasonable.

Projects can be as simple as decreasing the number of daily labs ordered by your hospitalist group. Projects that are small could still improve patient satisfaction and decrease costs. Listen to your colleagues, if they are discussing an issue, turn this into an idea! As you learn the culture of your hospital you will be able to tackle larger projects. Plus, it gets your name out there!

2. Establish buy-in: Surround yourself with champions of your cause. Properly identifying and engaging key players is paramount to a successful QI project. First, start with your hospital administration, and garner their support by aligning your project with the goals and objectives that the administration leaders have identified to be important for your institution. Next, select a motivated multidisciplinary team. When choosing your team, be sure to include a representative from the various stakeholders, that is, the individuals who have a variety of hospital roles likely to be affected by the outcome of the project. Stakeholders ensure the success of the project because they have a fundamental understanding of how the project will influence workflow, can predict issues before they arise, and often become empowered to make changes that directly influence their work.

Lastly, include at least one well-respected and highly influential member on your team. Change is always hard, and this person’s support and endorsement of the project, can often move mountains when challenges arise.

5. Remove waste: When determining QI projects, consider focusing on health care waste. Many of the current processes at our institutions have redundancies that add unhealthy time, effort, and inefficiency to our days that can not only impede patient care but also can lead to burnout. When outlining a project idea, consider mapping the process in your interested area to identify those redundancies and inefficiencies. Consider focusing on these instead of building an entirely new process. Improving inefficiencies also can help with provider buy-in with process changes, especially if this helps in improving their everyday frustrations.

6. Express your values: Create a sense of urgency around the problem you are trying to solve. Educate your colleagues to understand the depth of the QI initiative and its impact on their ability to care for patients and patient safety. Express genuine interest in improving your colleagues’ ability to care for patients and improve their days.

Sharing your passion about your project allows people to understand your vested interest in improving the system. This will inspire team members to lead the way to change and encourage colleagues to adopt the recommended changes.

7. Recognize and reward your team: Involve “champions” in every process change. Identify people who are part of your team and ensure they feel valued. Recognition and acknowledgment will allow people to feel more involved and to gain their buy-in. When it comes to results or progress, consider your group’s dynamics. If they are competitive, consider posting progress results on a publicly displayed run chart. If your group is less likely to be motivated by competition, hold individual meetings to help show progress. This is a crucial dynamic to understand, because creating a competitive environment may alienate some members of your group. Remember, the final result is not to blame those lagging behind but to encourage everyone to find the best pathway to success.

8. Be okay with failure: Celebrate your failures because failure is a chance to learn. Every failure is an educational opportunity to understand what not to do, or a chance to gain insight into a process that did not work.

Be a divergent thinker. Start considering problems as part of the path to solution, rather than a barrier in the way. Be open to change and learn from your mistakes. Don’t just be okay with your failures, own them. This will lead to trust with your team members and show your commitment.

9. Finish: This is key. You must finish your project. Even if you anticipate that the project will fail, you should see the project through to its completion. This proves both you and the process of QI are valid and worthwhile; you have to see results and share them with others.

Completing your project also shows your colleagues that you are resilient, committed, and dedicated. Completing a QI project, even with disappointing results, is a success in and of itself. In the end, it is most important to remember to show progress, not perfection.

10. Create sustainability: When your QI project is finished, you need to decide if the changes are sustainable. Some projects show small change and do not need permanent implementation, rather reminders over time. Other projects may be sustainable with EHR or organizational changes. Once you have successful results, your goal should be to find a way to ensure that the process stays in place over time. This is where all your hard work establishing buy-in comes in handy. Your team is more likely to create sustainable change with the hard work you forged through following these key tips.

These Top 10 tips are a hospitalist’s starting point to begin making changes at their own community hospital. Your motivation and effort in making quality change will not go unnoticed. Small ideas will open doors for larger, more sustainable QI projects. Remember, a failure just means a new idea for the next cycle! Enjoy the process of working collaboratively with your hospital on improving quality. Good luck!

Dr. Astik is a hospitalist and instructor of medicine at Northwestern Memorial Hospital, Chicago. Dr. Corbett is a hospitalist and assistant professor at the University of Oklahoma, Tulsa. Dr. Patel is a hospitalist and assistant professor at the University of Colorado, Denver. Dr. Ronan is a hospitalist and associate professor at Christus St. Vincent Regional Medical Center, Santa Fe, NM.

Quality improvement (QI) is essential to the advancement of medicine. QI differs from research as it focuses on already proven knowledge and aims to make quick, sustainable change in local health care systems. Community hospitals may not have organized quality improvement initiatives and often rely on individual hospitalists to be their champions.

Although there are resources for quality improvement projects, initiating a project can seem daunting to a hospitalist. Our aim is to equip the community hospitalist with basic skills to initiate their own successful project. We present our “Top 10” tips to review.



1. Start small: Many quality improvement ideas include grandiose changes that require a large buy-in or worse, more money. When starting a QI project, you need to consider low-cost, high-impact projects. Even the smallest projects can make considerable change. Focus on ideas that require only one or two improvement cycles to implement. Understand your hospital culture, flow, and processes, and then pick a project that is reasonable.

Projects can be as simple as decreasing the number of daily labs ordered by your hospitalist group. Projects that are small could still improve patient satisfaction and decrease costs. Listen to your colleagues, if they are discussing an issue, turn this into an idea! As you learn the culture of your hospital you will be able to tackle larger projects. Plus, it gets your name out there!

2. Establish buy-in: Surround yourself with champions of your cause. Properly identifying and engaging key players is paramount to a successful QI project. First, start with your hospital administration, and garner their support by aligning your project with the goals and objectives that the administration leaders have identified to be important for your institution. Next, select a motivated multidisciplinary team. When choosing your team, be sure to include a representative from the various stakeholders, that is, the individuals who have a variety of hospital roles likely to be affected by the outcome of the project. Stakeholders ensure the success of the project because they have a fundamental understanding of how the project will influence workflow, can predict issues before they arise, and often become empowered to make changes that directly influence their work.

Lastly, include at least one well-respected and highly influential member on your team. Change is always hard, and this person’s support and endorsement of the project, can often move mountains when challenges arise.

5. Remove waste: When determining QI projects, consider focusing on health care waste. Many of the current processes at our institutions have redundancies that add unhealthy time, effort, and inefficiency to our days that can not only impede patient care but also can lead to burnout. When outlining a project idea, consider mapping the process in your interested area to identify those redundancies and inefficiencies. Consider focusing on these instead of building an entirely new process. Improving inefficiencies also can help with provider buy-in with process changes, especially if this helps in improving their everyday frustrations.

6. Express your values: Create a sense of urgency around the problem you are trying to solve. Educate your colleagues to understand the depth of the QI initiative and its impact on their ability to care for patients and patient safety. Express genuine interest in improving your colleagues’ ability to care for patients and improve their days.

Sharing your passion about your project allows people to understand your vested interest in improving the system. This will inspire team members to lead the way to change and encourage colleagues to adopt the recommended changes.

7. Recognize and reward your team: Involve “champions” in every process change. Identify people who are part of your team and ensure they feel valued. Recognition and acknowledgment will allow people to feel more involved and to gain their buy-in. When it comes to results or progress, consider your group’s dynamics. If they are competitive, consider posting progress results on a publicly displayed run chart. If your group is less likely to be motivated by competition, hold individual meetings to help show progress. This is a crucial dynamic to understand, because creating a competitive environment may alienate some members of your group. Remember, the final result is not to blame those lagging behind but to encourage everyone to find the best pathway to success.

8. Be okay with failure: Celebrate your failures because failure is a chance to learn. Every failure is an educational opportunity to understand what not to do, or a chance to gain insight into a process that did not work.

Be a divergent thinker. Start considering problems as part of the path to solution, rather than a barrier in the way. Be open to change and learn from your mistakes. Don’t just be okay with your failures, own them. This will lead to trust with your team members and show your commitment.

9. Finish: This is key. You must finish your project. Even if you anticipate that the project will fail, you should see the project through to its completion. This proves both you and the process of QI are valid and worthwhile; you have to see results and share them with others.

Completing your project also shows your colleagues that you are resilient, committed, and dedicated. Completing a QI project, even with disappointing results, is a success in and of itself. In the end, it is most important to remember to show progress, not perfection.

10. Create sustainability: When your QI project is finished, you need to decide if the changes are sustainable. Some projects show small change and do not need permanent implementation, rather reminders over time. Other projects may be sustainable with EHR or organizational changes. Once you have successful results, your goal should be to find a way to ensure that the process stays in place over time. This is where all your hard work establishing buy-in comes in handy. Your team is more likely to create sustainable change with the hard work you forged through following these key tips.

These Top 10 tips are a hospitalist’s starting point to begin making changes at their own community hospital. Your motivation and effort in making quality change will not go unnoticed. Small ideas will open doors for larger, more sustainable QI projects. Remember, a failure just means a new idea for the next cycle! Enjoy the process of working collaboratively with your hospital on improving quality. Good luck!

Dr. Astik is a hospitalist and instructor of medicine at Northwestern Memorial Hospital, Chicago. Dr. Corbett is a hospitalist and assistant professor at the University of Oklahoma, Tulsa. Dr. Patel is a hospitalist and assistant professor at the University of Colorado, Denver. Dr. Ronan is a hospitalist and associate professor at Christus St. Vincent Regional Medical Center, Santa Fe, NM.

Quality improvement (QI) is essential to the advancement of medicine. QI differs from research as it focuses on already proven knowledge and aims to make quick, sustainable change in local health care systems. Community hospitals may not have organized quality improvement initiatives and often rely on individual hospitalists to be their champions.

Although there are resources for quality improvement projects, initiating a project can seem daunting to a hospitalist. Our aim is to equip the community hospitalist with basic skills to initiate their own successful project. We present our “Top 10” tips to review.



1. Start small: Many quality improvement ideas include grandiose changes that require a large buy-in or worse, more money. When starting a QI project, you need to consider low-cost, high-impact projects. Even the smallest projects can make considerable change. Focus on ideas that require only one or two improvement cycles to implement. Understand your hospital culture, flow, and processes, and then pick a project that is reasonable.

Projects can be as simple as decreasing the number of daily labs ordered by your hospitalist group. Projects that are small could still improve patient satisfaction and decrease costs. Listen to your colleagues, if they are discussing an issue, turn this into an idea! As you learn the culture of your hospital you will be able to tackle larger projects. Plus, it gets your name out there!

2. Establish buy-in: Surround yourself with champions of your cause. Properly identifying and engaging key players is paramount to a successful QI project. First, start with your hospital administration, and garner their support by aligning your project with the goals and objectives that the administration leaders have identified to be important for your institution. Next, select a motivated multidisciplinary team. When choosing your team, be sure to include a representative from the various stakeholders, that is, the individuals who have a variety of hospital roles likely to be affected by the outcome of the project. Stakeholders ensure the success of the project because they have a fundamental understanding of how the project will influence workflow, can predict issues before they arise, and often become empowered to make changes that directly influence their work.

Lastly, include at least one well-respected and highly influential member on your team. Change is always hard, and this person’s support and endorsement of the project, can often move mountains when challenges arise.

5. Remove waste: When determining QI projects, consider focusing on health care waste. Many of the current processes at our institutions have redundancies that add unhealthy time, effort, and inefficiency to our days that can not only impede patient care but also can lead to burnout. When outlining a project idea, consider mapping the process in your interested area to identify those redundancies and inefficiencies. Consider focusing on these instead of building an entirely new process. Improving inefficiencies also can help with provider buy-in with process changes, especially if this helps in improving their everyday frustrations.

6. Express your values: Create a sense of urgency around the problem you are trying to solve. Educate your colleagues to understand the depth of the QI initiative and its impact on their ability to care for patients and patient safety. Express genuine interest in improving your colleagues’ ability to care for patients and improve their days.

Sharing your passion about your project allows people to understand your vested interest in improving the system. This will inspire team members to lead the way to change and encourage colleagues to adopt the recommended changes.

7. Recognize and reward your team: Involve “champions” in every process change. Identify people who are part of your team and ensure they feel valued. Recognition and acknowledgment will allow people to feel more involved and to gain their buy-in. When it comes to results or progress, consider your group’s dynamics. If they are competitive, consider posting progress results on a publicly displayed run chart. If your group is less likely to be motivated by competition, hold individual meetings to help show progress. This is a crucial dynamic to understand, because creating a competitive environment may alienate some members of your group. Remember, the final result is not to blame those lagging behind but to encourage everyone to find the best pathway to success.

8. Be okay with failure: Celebrate your failures because failure is a chance to learn. Every failure is an educational opportunity to understand what not to do, or a chance to gain insight into a process that did not work.

Be a divergent thinker. Start considering problems as part of the path to solution, rather than a barrier in the way. Be open to change and learn from your mistakes. Don’t just be okay with your failures, own them. This will lead to trust with your team members and show your commitment.

9. Finish: This is key. You must finish your project. Even if you anticipate that the project will fail, you should see the project through to its completion. This proves both you and the process of QI are valid and worthwhile; you have to see results and share them with others.

Completing your project also shows your colleagues that you are resilient, committed, and dedicated. Completing a QI project, even with disappointing results, is a success in and of itself. In the end, it is most important to remember to show progress, not perfection.

10. Create sustainability: When your QI project is finished, you need to decide if the changes are sustainable. Some projects show small change and do not need permanent implementation, rather reminders over time. Other projects may be sustainable with EHR or organizational changes. Once you have successful results, your goal should be to find a way to ensure that the process stays in place over time. This is where all your hard work establishing buy-in comes in handy. Your team is more likely to create sustainable change with the hard work you forged through following these key tips.

These Top 10 tips are a hospitalist’s starting point to begin making changes at their own community hospital. Your motivation and effort in making quality change will not go unnoticed. Small ideas will open doors for larger, more sustainable QI projects. Remember, a failure just means a new idea for the next cycle! Enjoy the process of working collaboratively with your hospital on improving quality. Good luck!

Dr. Astik is a hospitalist and instructor of medicine at Northwestern Memorial Hospital, Chicago. Dr. Corbett is a hospitalist and assistant professor at the University of Oklahoma, Tulsa. Dr. Patel is a hospitalist and assistant professor at the University of Colorado, Denver. Dr. Ronan is a hospitalist and associate professor at Christus St. Vincent Regional Medical Center, Santa Fe, NM.

The Food and Drug Administration has approved Dengvaxia, the first vaccine indicated for the prevention of dengue virus disease caused by all viral serotypes. The vaccine was approved for children aged 9-16 years who live in endemic areas and have previously had laboratory-confirmed dengue disease.

Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands, according to an FDA statement announcing the approval.

While the first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu, a second infection can lead to a more severe form of the disease, including dengue hemorrhagic fever, which can be fatal. About 95% of hospitalized patients with dengue disease have a second dengue virus infection.

FDA approval of Dengvaxia is based on results from three randomized, placebo-controlled studies of 35,000 individuals in dengue-endemic areas. The vaccine was about 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in people aged 9-16 years with a previous dengue diagnosis. The most common adverse events were headache, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever; the frequency of adverse events decreased after each subsequent dose.

“Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease. ... The FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.

[email protected]

The Food and Drug Administration has approved Dengvaxia, the first vaccine indicated for the prevention of dengue virus disease caused by all viral serotypes. The vaccine was approved for children aged 9-16 years who live in endemic areas and have previously had laboratory-confirmed dengue disease.

Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands, according to an FDA statement announcing the approval.

While the first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu, a second infection can lead to a more severe form of the disease, including dengue hemorrhagic fever, which can be fatal. About 95% of hospitalized patients with dengue disease have a second dengue virus infection.

FDA approval of Dengvaxia is based on results from three randomized, placebo-controlled studies of 35,000 individuals in dengue-endemic areas. The vaccine was about 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in people aged 9-16 years with a previous dengue diagnosis. The most common adverse events were headache, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever; the frequency of adverse events decreased after each subsequent dose.

“Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease. ... The FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.

[email protected]

The Food and Drug Administration has approved Dengvaxia, the first vaccine indicated for the prevention of dengue virus disease caused by all viral serotypes. The vaccine was approved for children aged 9-16 years who live in endemic areas and have previously had laboratory-confirmed dengue disease.

Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands, according to an FDA statement announcing the approval.

While the first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu, a second infection can lead to a more severe form of the disease, including dengue hemorrhagic fever, which can be fatal. About 95% of hospitalized patients with dengue disease have a second dengue virus infection.

FDA approval of Dengvaxia is based on results from three randomized, placebo-controlled studies of 35,000 individuals in dengue-endemic areas. The vaccine was about 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in people aged 9-16 years with a previous dengue diagnosis. The most common adverse events were headache, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever; the frequency of adverse events decreased after each subsequent dose.

“Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease. ... The FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.

[email protected]

The addition of liraglutide to metformin shows significantly improved glycemic control in children and adolescents with type 2 diabetes, compared with metformin alone, according to data presented at the Pediatric Academic Societies annual meeting in Baltimore.

The phase 3 study, which was simultaneously published in the New England Journal of Medicine, involved 134 patients aged 10-17 years with type 2 diabetes who were managing their diabetes with diet and exercise, metformin, or insulin.

Participants were randomized either to subcutaneous liraglutide – dose-escalated up to 1.8 mg/day, depending on efficacy and side effects – or placebo for 52 weeks. The first 26 weeks were double blind and the second 26 weeks were an open-label extension period.

At 26 weeks, mean glycated hemoglobin levels in the liraglutide group had decreased by 0.64 percentage points from baseline, but in the placebo group they had increased by 0.42 percentage points, representing a treatment difference of –1.06 percentage points (P less than .001). By week 52, the treatment difference between the two groups had increased to –1.30 percentage points.

William V. Tamborlane, MD, from the department of pediatrics at Yale University, New Haven, Conn., and his coauthors wrote that metformin is the approved drug of choice for pediatric patients with type 2 diabetes, and that insulin currently is the only approved option for those who do not have an adequate response to metformin monotherapy.

“This discrepancy in available treatments for youth as compared with adults persists because of a lack of successfully completed trials needed for approval of new drugs for the treatment of type 2 diabetes in children since a trial of metformin was completed in 1999,” they wrote.

The study showed that significantly more patients in the liraglutide group (63.7%) achieved glycated hemoglobin levels below 7%, compared with 36.5% of patients in the placebo group. Fasting plasma glucose levels were decreased in the liraglutide group at both 26 and 52 weeks, but had increased in the placebo group.

Although the number of reported adverse events were similar between the two groups, there were significantly more reports of gastrointestinal adverse events – particularly nausea – in patients taking liraglutide, compared with those on placebo.

However, the study did not show a difference between liraglutide and placebo in lowering body mass index, although mean body weight decreases – which were seen in both groups – were maintained at week 52 only in the liraglutide group. The authors suggested this might be owing to the relatively small number of patients enrolled in the study and that some of the children were still growing.

Novo Nordisk, which manufactures liraglutide, supported the study. Twelve authors reported grants or support from Novo Nordisk in relation to the trial. Three authors were employees of Novo Nordisk. Eight authors reported unrelated grants and fees from Novo Nordisk and other pharmaceutical companies.

SOURCE: Tamborlane WV et al. N Engl J Med. 2019 Apr 28. doi: 10.1056/NEJMoa1903822.

The addition of liraglutide to metformin shows significantly improved glycemic control in children and adolescents with type 2 diabetes, compared with metformin alone, according to data presented at the Pediatric Academic Societies annual meeting in Baltimore.

The phase 3 study, which was simultaneously published in the New England Journal of Medicine, involved 134 patients aged 10-17 years with type 2 diabetes who were managing their diabetes with diet and exercise, metformin, or insulin.

Participants were randomized either to subcutaneous liraglutide – dose-escalated up to 1.8 mg/day, depending on efficacy and side effects – or placebo for 52 weeks. The first 26 weeks were double blind and the second 26 weeks were an open-label extension period.

At 26 weeks, mean glycated hemoglobin levels in the liraglutide group had decreased by 0.64 percentage points from baseline, but in the placebo group they had increased by 0.42 percentage points, representing a treatment difference of –1.06 percentage points (P less than .001). By week 52, the treatment difference between the two groups had increased to –1.30 percentage points.

William V. Tamborlane, MD, from the department of pediatrics at Yale University, New Haven, Conn., and his coauthors wrote that metformin is the approved drug of choice for pediatric patients with type 2 diabetes, and that insulin currently is the only approved option for those who do not have an adequate response to metformin monotherapy.

“This discrepancy in available treatments for youth as compared with adults persists because of a lack of successfully completed trials needed for approval of new drugs for the treatment of type 2 diabetes in children since a trial of metformin was completed in 1999,” they wrote.

The study showed that significantly more patients in the liraglutide group (63.7%) achieved glycated hemoglobin levels below 7%, compared with 36.5% of patients in the placebo group. Fasting plasma glucose levels were decreased in the liraglutide group at both 26 and 52 weeks, but had increased in the placebo group.

Although the number of reported adverse events were similar between the two groups, there were significantly more reports of gastrointestinal adverse events – particularly nausea – in patients taking liraglutide, compared with those on placebo.

However, the study did not show a difference between liraglutide and placebo in lowering body mass index, although mean body weight decreases – which were seen in both groups – were maintained at week 52 only in the liraglutide group. The authors suggested this might be owing to the relatively small number of patients enrolled in the study and that some of the children were still growing.

Novo Nordisk, which manufactures liraglutide, supported the study. Twelve authors reported grants or support from Novo Nordisk in relation to the trial. Three authors were employees of Novo Nordisk. Eight authors reported unrelated grants and fees from Novo Nordisk and other pharmaceutical companies.

SOURCE: Tamborlane WV et al. N Engl J Med. 2019 Apr 28. doi: 10.1056/NEJMoa1903822.

The addition of liraglutide to metformin shows significantly improved glycemic control in children and adolescents with type 2 diabetes, compared with metformin alone, according to data presented at the Pediatric Academic Societies annual meeting in Baltimore.

The phase 3 study, which was simultaneously published in the New England Journal of Medicine, involved 134 patients aged 10-17 years with type 2 diabetes who were managing their diabetes with diet and exercise, metformin, or insulin.

Participants were randomized either to subcutaneous liraglutide – dose-escalated up to 1.8 mg/day, depending on efficacy and side effects – or placebo for 52 weeks. The first 26 weeks were double blind and the second 26 weeks were an open-label extension period.

At 26 weeks, mean glycated hemoglobin levels in the liraglutide group had decreased by 0.64 percentage points from baseline, but in the placebo group they had increased by 0.42 percentage points, representing a treatment difference of –1.06 percentage points (P less than .001). By week 52, the treatment difference between the two groups had increased to –1.30 percentage points.

William V. Tamborlane, MD, from the department of pediatrics at Yale University, New Haven, Conn., and his coauthors wrote that metformin is the approved drug of choice for pediatric patients with type 2 diabetes, and that insulin currently is the only approved option for those who do not have an adequate response to metformin monotherapy.

“This discrepancy in available treatments for youth as compared with adults persists because of a lack of successfully completed trials needed for approval of new drugs for the treatment of type 2 diabetes in children since a trial of metformin was completed in 1999,” they wrote.

The study showed that significantly more patients in the liraglutide group (63.7%) achieved glycated hemoglobin levels below 7%, compared with 36.5% of patients in the placebo group. Fasting plasma glucose levels were decreased in the liraglutide group at both 26 and 52 weeks, but had increased in the placebo group.

Although the number of reported adverse events were similar between the two groups, there were significantly more reports of gastrointestinal adverse events – particularly nausea – in patients taking liraglutide, compared with those on placebo.

However, the study did not show a difference between liraglutide and placebo in lowering body mass index, although mean body weight decreases – which were seen in both groups – were maintained at week 52 only in the liraglutide group. The authors suggested this might be owing to the relatively small number of patients enrolled in the study and that some of the children were still growing.

Novo Nordisk, which manufactures liraglutide, supported the study. Twelve authors reported grants or support from Novo Nordisk in relation to the trial. Three authors were employees of Novo Nordisk. Eight authors reported unrelated grants and fees from Novo Nordisk and other pharmaceutical companies.

SOURCE: Tamborlane WV et al. N Engl J Med. 2019 Apr 28. doi: 10.1056/NEJMoa1903822.

Almost 31% of the estimated 54 million adults in the United States with arthritis have severe joint pain, according to the Centers for Disease Control and Prevention.

Nationally, the prevalence of severe joint pain was 30.8% in adults with arthritis in 2017, but state-specific, age-standardized prevalences varied from a low of 20.8% in Colorado to 45.2% in Mississippi. Regionally, prevalences of both severe joint pain and physical inactivity in arthritis patients were highest in the Southeast, noted Dana Guglielmo, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and associates (MMWR 2019 May 3;68(17):381-7).

The prevalence of arthritis itself was lowest in the District of Columbia at 15.7% and highest in West Virginia at 34.6%. Alabama, at 30.4%, was the only other state above 30%. Colorado had the lowest physical inactivity rate (23.2%), while Kentucky had the highest (44.4%), the investigators said.

The differences among arthritis patients were demographic as well as geographic in 2017. The prevalence of severe joint pain was 33.0% among those aged 18-44 years and 35.6% in those 45-64 but only 25.1% in those aged 65 and older. Whites had a 27.4% prevalence of severe joint pain, compared with 42.0% for Hispanics and 50.9% for blacks. For arthritis patients with a college degree, the age-standardized prevalence of severe joint pain was 15.1%, compared with 35.5% for high school graduates and 54.1% for those with less than a high school degree, based on data from the Behavioral Risk Factor Surveillance System.

“Although persons with arthritis report that pain, or fear of causing or worsening it, is a substantial barrier to exercising, physical activity is an inexpensive intervention that can reduce pain, prevent or delay disability and limitations, and improve mental health, physical functioning, and quality of life with few adverse effects,” wrote Ms. Guglielmo and associates. Adults with severe joint pain “should engage in regular physical activity according to their abilities and avoid physical inactivity [since] even small amounts of physical activity can improve physical functioning in adults with joint conditions.”

[email protected]

SOURCE: Guglielmo D et al. MMWR 2019 May 3;68(17):381-7.

Almost 31% of the estimated 54 million adults in the United States with arthritis have severe joint pain, according to the Centers for Disease Control and Prevention.

Nationally, the prevalence of severe joint pain was 30.8% in adults with arthritis in 2017, but state-specific, age-standardized prevalences varied from a low of 20.8% in Colorado to 45.2% in Mississippi. Regionally, prevalences of both severe joint pain and physical inactivity in arthritis patients were highest in the Southeast, noted Dana Guglielmo, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and associates (MMWR 2019 May 3;68(17):381-7).

The prevalence of arthritis itself was lowest in the District of Columbia at 15.7% and highest in West Virginia at 34.6%. Alabama, at 30.4%, was the only other state above 30%. Colorado had the lowest physical inactivity rate (23.2%), while Kentucky had the highest (44.4%), the investigators said.

The differences among arthritis patients were demographic as well as geographic in 2017. The prevalence of severe joint pain was 33.0% among those aged 18-44 years and 35.6% in those 45-64 but only 25.1% in those aged 65 and older. Whites had a 27.4% prevalence of severe joint pain, compared with 42.0% for Hispanics and 50.9% for blacks. For arthritis patients with a college degree, the age-standardized prevalence of severe joint pain was 15.1%, compared with 35.5% for high school graduates and 54.1% for those with less than a high school degree, based on data from the Behavioral Risk Factor Surveillance System.

“Although persons with arthritis report that pain, or fear of causing or worsening it, is a substantial barrier to exercising, physical activity is an inexpensive intervention that can reduce pain, prevent or delay disability and limitations, and improve mental health, physical functioning, and quality of life with few adverse effects,” wrote Ms. Guglielmo and associates. Adults with severe joint pain “should engage in regular physical activity according to their abilities and avoid physical inactivity [since] even small amounts of physical activity can improve physical functioning in adults with joint conditions.”

[email protected]

SOURCE: Guglielmo D et al. MMWR 2019 May 3;68(17):381-7.

Almost 31% of the estimated 54 million adults in the United States with arthritis have severe joint pain, according to the Centers for Disease Control and Prevention.

Nationally, the prevalence of severe joint pain was 30.8% in adults with arthritis in 2017, but state-specific, age-standardized prevalences varied from a low of 20.8% in Colorado to 45.2% in Mississippi. Regionally, prevalences of both severe joint pain and physical inactivity in arthritis patients were highest in the Southeast, noted Dana Guglielmo, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and associates (MMWR 2019 May 3;68(17):381-7).

The prevalence of arthritis itself was lowest in the District of Columbia at 15.7% and highest in West Virginia at 34.6%. Alabama, at 30.4%, was the only other state above 30%. Colorado had the lowest physical inactivity rate (23.2%), while Kentucky had the highest (44.4%), the investigators said.

The differences among arthritis patients were demographic as well as geographic in 2017. The prevalence of severe joint pain was 33.0% among those aged 18-44 years and 35.6% in those 45-64 but only 25.1% in those aged 65 and older. Whites had a 27.4% prevalence of severe joint pain, compared with 42.0% for Hispanics and 50.9% for blacks. For arthritis patients with a college degree, the age-standardized prevalence of severe joint pain was 15.1%, compared with 35.5% for high school graduates and 54.1% for those with less than a high school degree, based on data from the Behavioral Risk Factor Surveillance System.

“Although persons with arthritis report that pain, or fear of causing or worsening it, is a substantial barrier to exercising, physical activity is an inexpensive intervention that can reduce pain, prevent or delay disability and limitations, and improve mental health, physical functioning, and quality of life with few adverse effects,” wrote Ms. Guglielmo and associates. Adults with severe joint pain “should engage in regular physical activity according to their abilities and avoid physical inactivity [since] even small amounts of physical activity can improve physical functioning in adults with joint conditions.”

[email protected]

SOURCE: Guglielmo D et al. MMWR 2019 May 3;68(17):381-7.

NEWPORT BEACH, CALIF. – Researchers say they’ve found an association between the percentage of cytogenetically abnormal cells at allogeneic stem cell transplant (ASCT) and posttransplant outcomes in patients with myelodysplastic syndromes (MDS).

Patients who had more than 60% cytogenetically abnormal cells at ASCT had significantly inferior overall survival (OS) and relapse-free survival (RFS), compared to patients with fewer abnormal cells.

Dipenkumar Modi, MD, of Barbara Ann Karmanos Cancer Institute at Wayne State University in Detroit, and his colleagues conducted this research and presented the results at the Acute Leukemia Forum of Hemedicus.

The researchers studied 109 adult MDS patients who underwent ASCT from January 2000 through December 2016. The patients were divided into three groups based on the percentage of cytogenetically abnormal cells at ASCT:

• Group 1 had less than 30% (n = 22)
• Group 2 had 30%-60% (n = 23)
• Group 3 had greater than 60% (n = 64).

Baseline characteristics were largely similar between the groups. However, patients in group 3 were significantly more likely than those in groups 1 and 2 to have del(5q) and monosomy 5+7 (P = .048).

Patients in group 1 had a significantly higher percentage of bone marrow transplants (as opposed to peripheral blood stem cell transplants) than patients in groups 2 and 3 (P = .039). And patients in group 1 had significantly fewer blasts at ASCT than patients in groups 2 and 3 (P = .011).

The researchers found no significant between-group differences in relapse and nonrelapse mortality, but there were significant differences in OS and RFS.

Patients in group 3 had inferior RFS compared to patients in group 1, which was the reference group. The hazard ratio (HR) was 2.503 (P = .013) in a univariable analysis and 2.196 (P = .049) in a multivariable analysis.

Group 3 also had inferior OS compared to group 1. The hazard ratio was 2.589 (P = .021) in a univariable analysis and 2.478 (P = .040) in a multivariable analysis.

There was no significant difference in RFS or OS between groups 1 and 2. The HR for RFS in group 2 was 1.879 (P = .148) in a univariable analysis and 1.365 (P = .506) in a multivariable analysis. The HR for OS was 1.997 (P = .155) and 1.413 (P = .511), respectively.

Dr. Modi said these results suggest patients with greater than 60% cytogenetically abnormal cells at ASCT should be monitored more closely after transplant, and their immunosuppressive medication should be tapered as soon as possible.

Dr. Modi and his colleagues reported having no conflicts of interest relevant to this research.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers say they’ve found an association between the percentage of cytogenetically abnormal cells at allogeneic stem cell transplant (ASCT) and posttransplant outcomes in patients with myelodysplastic syndromes (MDS).

Patients who had more than 60% cytogenetically abnormal cells at ASCT had significantly inferior overall survival (OS) and relapse-free survival (RFS), compared to patients with fewer abnormal cells.

Dipenkumar Modi, MD, of Barbara Ann Karmanos Cancer Institute at Wayne State University in Detroit, and his colleagues conducted this research and presented the results at the Acute Leukemia Forum of Hemedicus.

The researchers studied 109 adult MDS patients who underwent ASCT from January 2000 through December 2016. The patients were divided into three groups based on the percentage of cytogenetically abnormal cells at ASCT:

• Group 1 had less than 30% (n = 22)
• Group 2 had 30%-60% (n = 23)
• Group 3 had greater than 60% (n = 64).

Baseline characteristics were largely similar between the groups. However, patients in group 3 were significantly more likely than those in groups 1 and 2 to have del(5q) and monosomy 5+7 (P = .048).

Patients in group 1 had a significantly higher percentage of bone marrow transplants (as opposed to peripheral blood stem cell transplants) than patients in groups 2 and 3 (P = .039). And patients in group 1 had significantly fewer blasts at ASCT than patients in groups 2 and 3 (P = .011).

The researchers found no significant between-group differences in relapse and nonrelapse mortality, but there were significant differences in OS and RFS.

Patients in group 3 had inferior RFS compared to patients in group 1, which was the reference group. The hazard ratio (HR) was 2.503 (P = .013) in a univariable analysis and 2.196 (P = .049) in a multivariable analysis.

Group 3 also had inferior OS compared to group 1. The hazard ratio was 2.589 (P = .021) in a univariable analysis and 2.478 (P = .040) in a multivariable analysis.

There was no significant difference in RFS or OS between groups 1 and 2. The HR for RFS in group 2 was 1.879 (P = .148) in a univariable analysis and 1.365 (P = .506) in a multivariable analysis. The HR for OS was 1.997 (P = .155) and 1.413 (P = .511), respectively.

Dr. Modi said these results suggest patients with greater than 60% cytogenetically abnormal cells at ASCT should be monitored more closely after transplant, and their immunosuppressive medication should be tapered as soon as possible.

Dr. Modi and his colleagues reported having no conflicts of interest relevant to this research.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers say they’ve found an association between the percentage of cytogenetically abnormal cells at allogeneic stem cell transplant (ASCT) and posttransplant outcomes in patients with myelodysplastic syndromes (MDS).

Patients who had more than 60% cytogenetically abnormal cells at ASCT had significantly inferior overall survival (OS) and relapse-free survival (RFS), compared to patients with fewer abnormal cells.

Dipenkumar Modi, MD, of Barbara Ann Karmanos Cancer Institute at Wayne State University in Detroit, and his colleagues conducted this research and presented the results at the Acute Leukemia Forum of Hemedicus.

The researchers studied 109 adult MDS patients who underwent ASCT from January 2000 through December 2016. The patients were divided into three groups based on the percentage of cytogenetically abnormal cells at ASCT:

• Group 1 had less than 30% (n = 22)
• Group 2 had 30%-60% (n = 23)
• Group 3 had greater than 60% (n = 64).

Baseline characteristics were largely similar between the groups. However, patients in group 3 were significantly more likely than those in groups 1 and 2 to have del(5q) and monosomy 5+7 (P = .048).

Patients in group 1 had a significantly higher percentage of bone marrow transplants (as opposed to peripheral blood stem cell transplants) than patients in groups 2 and 3 (P = .039). And patients in group 1 had significantly fewer blasts at ASCT than patients in groups 2 and 3 (P = .011).

The researchers found no significant between-group differences in relapse and nonrelapse mortality, but there were significant differences in OS and RFS.

Patients in group 3 had inferior RFS compared to patients in group 1, which was the reference group. The hazard ratio (HR) was 2.503 (P = .013) in a univariable analysis and 2.196 (P = .049) in a multivariable analysis.

Group 3 also had inferior OS compared to group 1. The hazard ratio was 2.589 (P = .021) in a univariable analysis and 2.478 (P = .040) in a multivariable analysis.

There was no significant difference in RFS or OS between groups 1 and 2. The HR for RFS in group 2 was 1.879 (P = .148) in a univariable analysis and 1.365 (P = .506) in a multivariable analysis. The HR for OS was 1.997 (P = .155) and 1.413 (P = .511), respectively.

Dr. Modi said these results suggest patients with greater than 60% cytogenetically abnormal cells at ASCT should be monitored more closely after transplant, and their immunosuppressive medication should be tapered as soon as possible.

Dr. Modi and his colleagues reported having no conflicts of interest relevant to this research.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

A migraine preventive with improved efficacy and adverse event profile and a favorable mode of administration would be valuable to patients with migraine, according to the results of a study published in Headache. When offered hypothetical preventive migraine medicines with a wide array of attributes, patients leaned toward those with a reduction in migraine days and an avoidance of weight gain, according to an analysis of responses to a discrete-choice experiment survey.

“We found that respondents had a significant willingness to pay for medicines with higher efficacy and less-severe adverse events,” wrote Carol Mansfield, PhD, of RTI Health Solutions in North Carolina, and coauthors.

To evaluate patient preferences for theoretical migraine medicine, the researchers conducted a discrete-choice experiment via a web-based survey. Respondents met eligibility criteria if they were adults aged 18 years or older who self-reported 6 or more migraine days per month and completed the survey in full. They were asked to choose between options defined by six attributes: reduction in headache days per month, frequency of limitations with physical activities, cognition problems, weight gain, how the medicine is taken, and monthly out-of-pocket cost.

Of the 300 respondents included in the analysis, 72% indicated that migraines make physical activities difficult all or most of the time, and 81% had taken a prescription migraine preventive in the last 6 months. Respondents reported, on average, approximately 16 headache days per month. Among noncost attributes, respondents valued a change from a 10% reduction in migraine days to a 50% reduction more highly than avoiding the worst levels of adverse events – defined as memory problems and 10% weight gain – but were willing to trade off efficacy for less-severe adverse events. Avoiding memory problems was more important than avoiding thinking problems. Avoiding a 10% weight gain was more important than avoiding thinking and memory problems. Respondents preferred a once-monthly injection or daily pill to twice-monthly injections. Respondents, on average, were willing to pay $116 per month for an improvement from 10% to 50% in reduced headache days (95% confidence interval [CI], $91-$141) and $43 for an improvement from 10% to 25% (95% CI, $34-$53). They were also willing to pay $84 per month to avoid a 10% weight gain (95% CI, $64-$103), $59 per month to avoid memory problems (95% CI, $42-$76), and $32 per month to avoid thinking problems (95% CI, $18-$46).

The coauthors acknowledged their study’s limitations, including all migraine diagnoses being self-reported and the study sample not necessarily being representative of patients with migraine overall. In addition, though the potential medicinal attributes used were prominent in clinical literature and focus groups, they could choose only a limited amount and so their analysis “did not address other attributes that may be important to patients.”

Given their findings, the researchers recommended that “clinicians should work with patients to select treatments that meet each patient’s needs.”

Amgen and Novartis funded the study. The authors reported numerous conflicts of interest, including receiving grants, consulting fees, and royalties from pharmaceutical companies and organizations. During the study, three of the authors were employed at RTI Health Solutions, a non-for-profit organization that conducts research with pharmaceutical companies such as the study’s sponsor.

SOURCE: Mansfield C et al. Headache. 2019 May;59(5):715-26. doi: 10.1111/head.13498.

A migraine preventive with improved efficacy and adverse event profile and a favorable mode of administration would be valuable to patients with migraine, according to the results of a study published in Headache. When offered hypothetical preventive migraine medicines with a wide array of attributes, patients leaned toward those with a reduction in migraine days and an avoidance of weight gain, according to an analysis of responses to a discrete-choice experiment survey.

“We found that respondents had a significant willingness to pay for medicines with higher efficacy and less-severe adverse events,” wrote Carol Mansfield, PhD, of RTI Health Solutions in North Carolina, and coauthors.

To evaluate patient preferences for theoretical migraine medicine, the researchers conducted a discrete-choice experiment via a web-based survey. Respondents met eligibility criteria if they were adults aged 18 years or older who self-reported 6 or more migraine days per month and completed the survey in full. They were asked to choose between options defined by six attributes: reduction in headache days per month, frequency of limitations with physical activities, cognition problems, weight gain, how the medicine is taken, and monthly out-of-pocket cost.

Of the 300 respondents included in the analysis, 72% indicated that migraines make physical activities difficult all or most of the time, and 81% had taken a prescription migraine preventive in the last 6 months. Respondents reported, on average, approximately 16 headache days per month. Among noncost attributes, respondents valued a change from a 10% reduction in migraine days to a 50% reduction more highly than avoiding the worst levels of adverse events – defined as memory problems and 10% weight gain – but were willing to trade off efficacy for less-severe adverse events. Avoiding memory problems was more important than avoiding thinking problems. Avoiding a 10% weight gain was more important than avoiding thinking and memory problems. Respondents preferred a once-monthly injection or daily pill to twice-monthly injections. Respondents, on average, were willing to pay $116 per month for an improvement from 10% to 50% in reduced headache days (95% confidence interval [CI], $91-$141) and $43 for an improvement from 10% to 25% (95% CI, $34-$53). They were also willing to pay $84 per month to avoid a 10% weight gain (95% CI, $64-$103), $59 per month to avoid memory problems (95% CI, $42-$76), and $32 per month to avoid thinking problems (95% CI, $18-$46).

The coauthors acknowledged their study’s limitations, including all migraine diagnoses being self-reported and the study sample not necessarily being representative of patients with migraine overall. In addition, though the potential medicinal attributes used were prominent in clinical literature and focus groups, they could choose only a limited amount and so their analysis “did not address other attributes that may be important to patients.”

Given their findings, the researchers recommended that “clinicians should work with patients to select treatments that meet each patient’s needs.”

Amgen and Novartis funded the study. The authors reported numerous conflicts of interest, including receiving grants, consulting fees, and royalties from pharmaceutical companies and organizations. During the study, three of the authors were employed at RTI Health Solutions, a non-for-profit organization that conducts research with pharmaceutical companies such as the study’s sponsor.

SOURCE: Mansfield C et al. Headache. 2019 May;59(5):715-26. doi: 10.1111/head.13498.

A migraine preventive with improved efficacy and adverse event profile and a favorable mode of administration would be valuable to patients with migraine, according to the results of a study published in Headache. When offered hypothetical preventive migraine medicines with a wide array of attributes, patients leaned toward those with a reduction in migraine days and an avoidance of weight gain, according to an analysis of responses to a discrete-choice experiment survey.

“We found that respondents had a significant willingness to pay for medicines with higher efficacy and less-severe adverse events,” wrote Carol Mansfield, PhD, of RTI Health Solutions in North Carolina, and coauthors.

To evaluate patient preferences for theoretical migraine medicine, the researchers conducted a discrete-choice experiment via a web-based survey. Respondents met eligibility criteria if they were adults aged 18 years or older who self-reported 6 or more migraine days per month and completed the survey in full. They were asked to choose between options defined by six attributes: reduction in headache days per month, frequency of limitations with physical activities, cognition problems, weight gain, how the medicine is taken, and monthly out-of-pocket cost.

Of the 300 respondents included in the analysis, 72% indicated that migraines make physical activities difficult all or most of the time, and 81% had taken a prescription migraine preventive in the last 6 months. Respondents reported, on average, approximately 16 headache days per month. Among noncost attributes, respondents valued a change from a 10% reduction in migraine days to a 50% reduction more highly than avoiding the worst levels of adverse events – defined as memory problems and 10% weight gain – but were willing to trade off efficacy for less-severe adverse events. Avoiding memory problems was more important than avoiding thinking problems. Avoiding a 10% weight gain was more important than avoiding thinking and memory problems. Respondents preferred a once-monthly injection or daily pill to twice-monthly injections. Respondents, on average, were willing to pay $116 per month for an improvement from 10% to 50% in reduced headache days (95% confidence interval [CI], $91-$141) and $43 for an improvement from 10% to 25% (95% CI, $34-$53). They were also willing to pay $84 per month to avoid a 10% weight gain (95% CI, $64-$103), $59 per month to avoid memory problems (95% CI, $42-$76), and $32 per month to avoid thinking problems (95% CI, $18-$46).

The coauthors acknowledged their study’s limitations, including all migraine diagnoses being self-reported and the study sample not necessarily being representative of patients with migraine overall. In addition, though the potential medicinal attributes used were prominent in clinical literature and focus groups, they could choose only a limited amount and so their analysis “did not address other attributes that may be important to patients.”

Given their findings, the researchers recommended that “clinicians should work with patients to select treatments that meet each patient’s needs.”

Amgen and Novartis funded the study. The authors reported numerous conflicts of interest, including receiving grants, consulting fees, and royalties from pharmaceutical companies and organizations. During the study, three of the authors were employed at RTI Health Solutions, a non-for-profit organization that conducts research with pharmaceutical companies such as the study’s sponsor.

SOURCE: Mansfield C et al. Headache. 2019 May;59(5):715-26. doi: 10.1111/head.13498.

The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.

The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.

Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.

The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.

“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.

The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.

Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.

The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.

“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.

The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.

Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.

The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.

“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.

Find the full press release on the FDA website.

[email protected]

NEW ORLEANS – The gene therapy LentiGlobin can reduce transfusion dependence in children and young adults with non-beta⁰/beta⁰ thalassemia, according to two trials.

Jennifer Smith/MDedge News

In a phase 1/2 trial, 8 of 10 of patients achieved transfusion independence at a median follow-up of 36.0 months. In a phase 3 trial, transfusion independence was achieved by 2 of 3 patients with follow-up of at least 12 months.

Timothy S. Olson, MD, PhD, of Children’s Hospital of Philadelphia, presented results from the phase 1/2 HGB-204 trial and the phase 3 HGB-207 trial at the annual meeting of the American Society of Pediatric Hematology/Oncology.
 

Treatment

In both trials, patients received granulocyte colony-stimulating factor and plerixafor for hematopoietic stem cell mobilization. Their cells were collected via apheresis and transduced with the betibeglogene darolentivec (BB305) lentiviral vector. The patients received busulfan (for an average of 4 days) as conditioning and were infused with the transduced cells.

The manufacturing process for LentiGlobin was refined in the HGB-207 trial, which translated to a product with a higher vector copy number and higher proportion of CD34+ cells transduced, Dr. Olson said.

The median vector copy number was 3.1 in the HGB-207 trial and 0.7 in the HGB-204 trial. The median proportion of CD34+ cells transfused was 81% and 29%, respectively. The median cell dose was 7.7 x 10⁶ CD34+ cells/kg and 7.1 x 10⁶ CD34+ cells/kg, respectively.

HGB-204 patients and efficacy

The HGB-204 trial included 10 patients with non-beta⁰/beta⁰ genotypes – 6 with beta^E/beta⁰, 1 with beta⁺/beta⁰, 2 with beta⁺/beta⁺, and 1 with an “other” genotype.

The patients’ median age at consent was 19.5 years (range, 16-34). The annualized median prestudy red blood cell (RBC) transfusion volume was 151 mL/kg per year.


At a median follow-up of 36 months, 8 of the 10 patients achieved transfusion independence. The median duration of transfusion independence was 38 months. The median weighted average hemoglobin during transfusion independence was 10.2 g/dL.

“Two patients did not achieve transfusion independence, and both patients were on the lower end of the spectrum both in terms of vector copy number per cell and the percentage of CD34+ cells that were successfully transduced,” Dr. Olson said. “Both patients actually experienced a reduction in the annualized transfusion volume requirements of between 43% and 77%.”

HGB-207 patients and efficacy

The HGB-207 trial included 16 patients with non-beta⁰/beta⁰ genotypes – 6 with beta^E/beta⁰, 7 with beta⁺/beta⁰, and 3 with the beta⁺/beta⁺ genotype.

The patients’ median age at consent was 19 years . The annualized median prestudy RBC transfusion volume was 192 mL/kg per year.

The median follow-up in this trial is 9.3 months. Ten of 11 patients with at least 3 months of follow-up are transfusion-free with hemoglobin levels greater than 11 g/dL.

Two patients have achieved transfusion independence according to the protocol definition, which is weighted average hemoglobin of 9 g/dL or greater without any RBC transfusions for at least 12 months.

“In the one patient in this study who did not achieve transfusion independence, the vector-derived hemoglobin was quite low, and this correlated with a very low vector copy number seen in circulating peripheral blood mononuclear cells,” Dr. Olson said.

It isn’t clear why this occurred, however, as the vector copy number wasn’t especially low in the LentiGlobin product the patient received. Therefore, the researchers are still investigating why this patient failed to achieve transfusion independence.

Safety in both trials

“Very importantly, there were no deaths, there were no engraftment failures, there was no evidence of vector-mediated replication-competent lentivirus, and integration site analysis revealed no evidence of clonal dominance,” Dr. Olson said.

He added that most of the grade 3 or greater adverse events seen in both trials were directly attributable to busulfan-based myeloablative conditioning, including four episodes of veno-occlusive disease.

Nonhematologic grade 3 or higher adverse events in HGB-204 included stomatitis (n = 8), febrile neutropenia (n = 6), irregular menstruation (n = 3), pharyngeal inflammation (n = 2), and veno-occlusive liver disease (n = 1).

Nonhematologic grade 3 or higher adverse events in HGB-207 included stomatitis (n = 9), febrile neutropenia (n = 4), pharyngeal inflammation (n = 2), epistaxis (n = 3), pyrexia (n = 3), veno-occlusive liver disease (n = 3), ALT increase (n = 2), bilirubin increase (n = 2), and hypoxia (n = 2).

One patient in HGB-207 had grade 3 thrombocytopenia considered possibly related to LentiGlobin.

Dr. Olson reported advisory board engagement with bluebird bio, which sponsored both trials.

[email protected]

SOURCE: Olson TS et al. ASPHO 2019. Abstract 2002.

NEW ORLEANS – The gene therapy LentiGlobin can reduce transfusion dependence in children and young adults with non-beta⁰/beta⁰ thalassemia, according to two trials.

Jennifer Smith/MDedge News

In a phase 1/2 trial, 8 of 10 of patients achieved transfusion independence at a median follow-up of 36.0 months. In a phase 3 trial, transfusion independence was achieved by 2 of 3 patients with follow-up of at least 12 months.

Timothy S. Olson, MD, PhD, of Children’s Hospital of Philadelphia, presented results from the phase 1/2 HGB-204 trial and the phase 3 HGB-207 trial at the annual meeting of the American Society of Pediatric Hematology/Oncology.
 

Treatment

In both trials, patients received granulocyte colony-stimulating factor and plerixafor for hematopoietic stem cell mobilization. Their cells were collected via apheresis and transduced with the betibeglogene darolentivec (BB305) lentiviral vector. The patients received busulfan (for an average of 4 days) as conditioning and were infused with the transduced cells.

The manufacturing process for LentiGlobin was refined in the HGB-207 trial, which translated to a product with a higher vector copy number and higher proportion of CD34+ cells transduced, Dr. Olson said.

The median vector copy number was 3.1 in the HGB-207 trial and 0.7 in the HGB-204 trial. The median proportion of CD34+ cells transfused was 81% and 29%, respectively. The median cell dose was 7.7 x 10⁶ CD34+ cells/kg and 7.1 x 10⁶ CD34+ cells/kg, respectively.

HGB-204 patients and efficacy

The HGB-204 trial included 10 patients with non-beta⁰/beta⁰ genotypes – 6 with beta^E/beta⁰, 1 with beta⁺/beta⁰, 2 with beta⁺/beta⁺, and 1 with an “other” genotype.

The patients’ median age at consent was 19.5 years (range, 16-34). The annualized median prestudy red blood cell (RBC) transfusion volume was 151 mL/kg per year.


At a median follow-up of 36 months, 8 of the 10 patients achieved transfusion independence. The median duration of transfusion independence was 38 months. The median weighted average hemoglobin during transfusion independence was 10.2 g/dL.

“Two patients did not achieve transfusion independence, and both patients were on the lower end of the spectrum both in terms of vector copy number per cell and the percentage of CD34+ cells that were successfully transduced,” Dr. Olson said. “Both patients actually experienced a reduction in the annualized transfusion volume requirements of between 43% and 77%.”

HGB-207 patients and efficacy

The HGB-207 trial included 16 patients with non-beta⁰/beta⁰ genotypes – 6 with beta^E/beta⁰, 7 with beta⁺/beta⁰, and 3 with the beta⁺/beta⁺ genotype.

The patients’ median age at consent was 19 years . The annualized median prestudy RBC transfusion volume was 192 mL/kg per year.

The median follow-up in this trial is 9.3 months. Ten of 11 patients with at least 3 months of follow-up are transfusion-free with hemoglobin levels greater than 11 g/dL.

Two patients have achieved transfusion independence according to the protocol definition, which is weighted average hemoglobin of 9 g/dL or greater without any RBC transfusions for at least 12 months.

“In the one patient in this study who did not achieve transfusion independence, the vector-derived hemoglobin was quite low, and this correlated with a very low vector copy number seen in circulating peripheral blood mononuclear cells,” Dr. Olson said.

It isn’t clear why this occurred, however, as the vector copy number wasn’t especially low in the LentiGlobin product the patient received. Therefore, the researchers are still investigating why this patient failed to achieve transfusion independence.

Safety in both trials

“Very importantly, there were no deaths, there were no engraftment failures, there was no evidence of vector-mediated replication-competent lentivirus, and integration site analysis revealed no evidence of clonal dominance,” Dr. Olson said.

He added that most of the grade 3 or greater adverse events seen in both trials were directly attributable to busulfan-based myeloablative conditioning, including four episodes of veno-occlusive disease.

Nonhematologic grade 3 or higher adverse events in HGB-204 included stomatitis (n = 8), febrile neutropenia (n = 6), irregular menstruation (n = 3), pharyngeal inflammation (n = 2), and veno-occlusive liver disease (n = 1).

Nonhematologic grade 3 or higher adverse events in HGB-207 included stomatitis (n = 9), febrile neutropenia (n = 4), pharyngeal inflammation (n = 2), epistaxis (n = 3), pyrexia (n = 3), veno-occlusive liver disease (n = 3), ALT increase (n = 2), bilirubin increase (n = 2), and hypoxia (n = 2).

One patient in HGB-207 had grade 3 thrombocytopenia considered possibly related to LentiGlobin.

Dr. Olson reported advisory board engagement with bluebird bio, which sponsored both trials.

[email protected]

SOURCE: Olson TS et al. ASPHO 2019. Abstract 2002.

NEW ORLEANS – The gene therapy LentiGlobin can reduce transfusion dependence in children and young adults with non-beta⁰/beta⁰ thalassemia, according to two trials.

Jennifer Smith/MDedge News

In a phase 1/2 trial, 8 of 10 of patients achieved transfusion independence at a median follow-up of 36.0 months. In a phase 3 trial, transfusion independence was achieved by 2 of 3 patients with follow-up of at least 12 months.

Timothy S. Olson, MD, PhD, of Children’s Hospital of Philadelphia, presented results from the phase 1/2 HGB-204 trial and the phase 3 HGB-207 trial at the annual meeting of the American Society of Pediatric Hematology/Oncology.
 

Treatment

In both trials, patients received granulocyte colony-stimulating factor and plerixafor for hematopoietic stem cell mobilization. Their cells were collected via apheresis and transduced with the betibeglogene darolentivec (BB305) lentiviral vector. The patients received busulfan (for an average of 4 days) as conditioning and were infused with the transduced cells.

The manufacturing process for LentiGlobin was refined in the HGB-207 trial, which translated to a product with a higher vector copy number and higher proportion of CD34+ cells transduced, Dr. Olson said.

The median vector copy number was 3.1 in the HGB-207 trial and 0.7 in the HGB-204 trial. The median proportion of CD34+ cells transfused was 81% and 29%, respectively. The median cell dose was 7.7 x 10⁶ CD34+ cells/kg and 7.1 x 10⁶ CD34+ cells/kg, respectively.

HGB-204 patients and efficacy

The HGB-204 trial included 10 patients with non-beta⁰/beta⁰ genotypes – 6 with beta^E/beta⁰, 1 with beta⁺/beta⁰, 2 with beta⁺/beta⁺, and 1 with an “other” genotype.

The patients’ median age at consent was 19.5 years (range, 16-34). The annualized median prestudy red blood cell (RBC) transfusion volume was 151 mL/kg per year.


At a median follow-up of 36 months, 8 of the 10 patients achieved transfusion independence. The median duration of transfusion independence was 38 months. The median weighted average hemoglobin during transfusion independence was 10.2 g/dL.

“Two patients did not achieve transfusion independence, and both patients were on the lower end of the spectrum both in terms of vector copy number per cell and the percentage of CD34+ cells that were successfully transduced,” Dr. Olson said. “Both patients actually experienced a reduction in the annualized transfusion volume requirements of between 43% and 77%.”

HGB-207 patients and efficacy

The HGB-207 trial included 16 patients with non-beta⁰/beta⁰ genotypes – 6 with beta^E/beta⁰, 7 with beta⁺/beta⁰, and 3 with the beta⁺/beta⁺ genotype.

The patients’ median age at consent was 19 years . The annualized median prestudy RBC transfusion volume was 192 mL/kg per year.

The median follow-up in this trial is 9.3 months. Ten of 11 patients with at least 3 months of follow-up are transfusion-free with hemoglobin levels greater than 11 g/dL.

Two patients have achieved transfusion independence according to the protocol definition, which is weighted average hemoglobin of 9 g/dL or greater without any RBC transfusions for at least 12 months.

“In the one patient in this study who did not achieve transfusion independence, the vector-derived hemoglobin was quite low, and this correlated with a very low vector copy number seen in circulating peripheral blood mononuclear cells,” Dr. Olson said.

It isn’t clear why this occurred, however, as the vector copy number wasn’t especially low in the LentiGlobin product the patient received. Therefore, the researchers are still investigating why this patient failed to achieve transfusion independence.

Safety in both trials

“Very importantly, there were no deaths, there were no engraftment failures, there was no evidence of vector-mediated replication-competent lentivirus, and integration site analysis revealed no evidence of clonal dominance,” Dr. Olson said.

He added that most of the grade 3 or greater adverse events seen in both trials were directly attributable to busulfan-based myeloablative conditioning, including four episodes of veno-occlusive disease.

Nonhematologic grade 3 or higher adverse events in HGB-204 included stomatitis (n = 8), febrile neutropenia (n = 6), irregular menstruation (n = 3), pharyngeal inflammation (n = 2), and veno-occlusive liver disease (n = 1).

Nonhematologic grade 3 or higher adverse events in HGB-207 included stomatitis (n = 9), febrile neutropenia (n = 4), pharyngeal inflammation (n = 2), epistaxis (n = 3), pyrexia (n = 3), veno-occlusive liver disease (n = 3), ALT increase (n = 2), bilirubin increase (n = 2), and hypoxia (n = 2).

One patient in HGB-207 had grade 3 thrombocytopenia considered possibly related to LentiGlobin.

Dr. Olson reported advisory board engagement with bluebird bio, which sponsored both trials.

[email protected]

SOURCE: Olson TS et al. ASPHO 2019. Abstract 2002.

Isolated limb perfusion (ILP) for the adjuvant treatment of melanoma involves isolating the blood flow of a limb from the rest of the body to allow for high concentrations of chemotherapeutic agents locally. Chemotherapy with nitrogen mustard is the preferred chemotherapeutic agent in ILP for the adjuvant treatment of locally advanced melanoma.¹ Systemic exposure to nitrogen mustard has shown to be carcinogenic, and its topical application has been associated with the development of actinic keratosis, basal cell carcinoma (BCC), and squamous cell carcinoma.^2,3 However, the long-term effects of ILP with nitrogen mustard are not well defined. In 1998, one of the authors (R.L.M.) described a patient with melanoma of the left leg that was treated with ILP with nitrogen mustard who subsequently developed numerous BCCs on the same leg.⁴ This same patient has since been successfully managed with only topical chemotherapeutic agents for the last 21 years.

An 86-year-old man with a history of melanoma underwent wide resection, lymph node dissection, and adjuvant ILP with nitrogen mustard for the treatment of melanoma of the medial left thigh approximately 50 years ago. He denied any prior radiation treatment. He subsequently presented years later to our dermatology clinic with many biopsy-proven superficial and nodular BCCs of the left leg over the course of the last 30 years. On physical examination, the patient had several pink papules and macules on the left lower leg (Figure). The patient had previously undergone multiple invasive excisions with grafting for the treatment of BCCs by a plastic surgeon prior to presentation to our clinic but has since had many years of control under our care with only topical chemotherapeutic agents. His current medication regimen consists of 5-fluorouracil twice daily, which he tolerates without serious side effects. He also has used imiquimod in the past.

Treatment modalities for NMSC include surgical excision with defined margins, Mohs micrographic surgery, radiotherapy, electrodesiccation and curettage, cryotherapy, photodynamic therapy, and topical therapy. Our patient experienced such a high volume of superficial BCCs that the decision was made to avoid frequent surgical procedures and to treat with topical chemotherapeutic agents. He had an excellent response to topical 5-fluorouracil, and the treatment has been well tolerated. This case is valuable for clinicians, as it demonstrates that topical chemotherapy can be a well-tolerated option for patients who present with frequent superficial BCCs to prevent numerous invasive surgical treatments.

Isolated limb perfusion (ILP) for the adjuvant treatment of melanoma involves isolating the blood flow of a limb from the rest of the body to allow for high concentrations of chemotherapeutic agents locally. Chemotherapy with nitrogen mustard is the preferred chemotherapeutic agent in ILP for the adjuvant treatment of locally advanced melanoma.¹ Systemic exposure to nitrogen mustard has shown to be carcinogenic, and its topical application has been associated with the development of actinic keratosis, basal cell carcinoma (BCC), and squamous cell carcinoma.^2,3 However, the long-term effects of ILP with nitrogen mustard are not well defined. In 1998, one of the authors (R.L.M.) described a patient with melanoma of the left leg that was treated with ILP with nitrogen mustard who subsequently developed numerous BCCs on the same leg.⁴ This same patient has since been successfully managed with only topical chemotherapeutic agents for the last 21 years.

An 86-year-old man with a history of melanoma underwent wide resection, lymph node dissection, and adjuvant ILP with nitrogen mustard for the treatment of melanoma of the medial left thigh approximately 50 years ago. He denied any prior radiation treatment. He subsequently presented years later to our dermatology clinic with many biopsy-proven superficial and nodular BCCs of the left leg over the course of the last 30 years. On physical examination, the patient had several pink papules and macules on the left lower leg (Figure). The patient had previously undergone multiple invasive excisions with grafting for the treatment of BCCs by a plastic surgeon prior to presentation to our clinic but has since had many years of control under our care with only topical chemotherapeutic agents. His current medication regimen consists of 5-fluorouracil twice daily, which he tolerates without serious side effects. He also has used imiquimod in the past.

Treatment modalities for NMSC include surgical excision with defined margins, Mohs micrographic surgery, radiotherapy, electrodesiccation and curettage, cryotherapy, photodynamic therapy, and topical therapy. Our patient experienced such a high volume of superficial BCCs that the decision was made to avoid frequent surgical procedures and to treat with topical chemotherapeutic agents. He had an excellent response to topical 5-fluorouracil, and the treatment has been well tolerated. This case is valuable for clinicians, as it demonstrates that topical chemotherapy can be a well-tolerated option for patients who present with frequent superficial BCCs to prevent numerous invasive surgical treatments.

Isolated limb perfusion (ILP) for the adjuvant treatment of melanoma involves isolating the blood flow of a limb from the rest of the body to allow for high concentrations of chemotherapeutic agents locally. Chemotherapy with nitrogen mustard is the preferred chemotherapeutic agent in ILP for the adjuvant treatment of locally advanced melanoma.¹ Systemic exposure to nitrogen mustard has shown to be carcinogenic, and its topical application has been associated with the development of actinic keratosis, basal cell carcinoma (BCC), and squamous cell carcinoma.^2,3 However, the long-term effects of ILP with nitrogen mustard are not well defined. In 1998, one of the authors (R.L.M.) described a patient with melanoma of the left leg that was treated with ILP with nitrogen mustard who subsequently developed numerous BCCs on the same leg.⁴ This same patient has since been successfully managed with only topical chemotherapeutic agents for the last 21 years.

An 86-year-old man with a history of melanoma underwent wide resection, lymph node dissection, and adjuvant ILP with nitrogen mustard for the treatment of melanoma of the medial left thigh approximately 50 years ago. He denied any prior radiation treatment. He subsequently presented years later to our dermatology clinic with many biopsy-proven superficial and nodular BCCs of the left leg over the course of the last 30 years. On physical examination, the patient had several pink papules and macules on the left lower leg (Figure). The patient had previously undergone multiple invasive excisions with grafting for the treatment of BCCs by a plastic surgeon prior to presentation to our clinic but has since had many years of control under our care with only topical chemotherapeutic agents. His current medication regimen consists of 5-fluorouracil twice daily, which he tolerates without serious side effects. He also has used imiquimod in the past.

Treatment modalities for NMSC include surgical excision with defined margins, Mohs micrographic surgery, radiotherapy, electrodesiccation and curettage, cryotherapy, photodynamic therapy, and topical therapy. Our patient experienced such a high volume of superficial BCCs that the decision was made to avoid frequent surgical procedures and to treat with topical chemotherapeutic agents. He had an excellent response to topical 5-fluorouracil, and the treatment has been well tolerated. This case is valuable for clinicians, as it demonstrates that topical chemotherapy can be a well-tolerated option for patients who present with frequent superficial BCCs to prevent numerous invasive surgical treatments.

The vast majority of individuals at high risk for opioid overdose do not receive naloxone, despite numerous opportunities, according to Sarah Follman and associates from the University of Chicago.

In a retrospective study published in JAMA Network Open, the study authors analyzed data from individuals in the Truven Health MarketScan Research Database who had ICD-10 codes related to opioid use, misuse, dependence, and overdose. Data from Oct. 1, 2015, through Dec. 31, 2016, were included; a total of 138,108 high-risk individuals were identified as interacting with the health care system nearly 1.2 million times (88,618 hospitalizations, 229,680 ED visits, 298,058 internal medicine visits, and 568,448 family practice visits).

Of the 138,108 individuals in the study, only 2,135 (1.5%) were prescribed naloxone during the study period. Patients who had prior diagnoses of both opioid misuse/dependence and overdose were significantly more likely to receive naloxone than were those who only had a history of opioid dependence (odds ratio, 2.32; 95% confidence interval, 1.98-2.72; P less than .001). In addition, having a history of overdose alone was associated with a decreased chance of receiving naloxone, compared with those with a history of opioid misuse alone (OR, 0.73; 95% CI, 0.57-0.94; P = .01).

Other factors that significantly reduced the odds of receiving naloxone included being aged 30-44 years and being from the Midwest or West. Factors that reduced the odds include having received treatment for opioid use disorder, visiting a detoxification facility, receiving other substance use disorder treatment; and having received outpatient care from a pain specialist, psychologist, or surgeon.

“Most individuals at high risk of opioid overdose do not receive naloxone through direct prescribing,” Ms. Follman and associates wrote. “Clinicians can address this gap by regularly prescribing naloxone to eligible patients. To address barriers to prescribing, hospital systems and medical schools can support clinicians by improving education on screening and treating substance use disorders, clarifying legal concerns, and developing policies and protocols to guide implementation of increased prescribing. “Health care systems can also create or strengthen processes to encourage naloxone prescribing.”

No conflicts of interest were reported; one coauthor reported receiving a grant from the National Institutes of Health.

[email protected]

SOURCE: Follman S et al. JAMA Netw Open. 2019 May 3. doi: 10.1001/jamanetworkopen.2019.3209.

The vast majority of individuals at high risk for opioid overdose do not receive naloxone, despite numerous opportunities, according to Sarah Follman and associates from the University of Chicago.

In a retrospective study published in JAMA Network Open, the study authors analyzed data from individuals in the Truven Health MarketScan Research Database who had ICD-10 codes related to opioid use, misuse, dependence, and overdose. Data from Oct. 1, 2015, through Dec. 31, 2016, were included; a total of 138,108 high-risk individuals were identified as interacting with the health care system nearly 1.2 million times (88,618 hospitalizations, 229,680 ED visits, 298,058 internal medicine visits, and 568,448 family practice visits).

Of the 138,108 individuals in the study, only 2,135 (1.5%) were prescribed naloxone during the study period. Patients who had prior diagnoses of both opioid misuse/dependence and overdose were significantly more likely to receive naloxone than were those who only had a history of opioid dependence (odds ratio, 2.32; 95% confidence interval, 1.98-2.72; P less than .001). In addition, having a history of overdose alone was associated with a decreased chance of receiving naloxone, compared with those with a history of opioid misuse alone (OR, 0.73; 95% CI, 0.57-0.94; P = .01).

Other factors that significantly reduced the odds of receiving naloxone included being aged 30-44 years and being from the Midwest or West. Factors that reduced the odds include having received treatment for opioid use disorder, visiting a detoxification facility, receiving other substance use disorder treatment; and having received outpatient care from a pain specialist, psychologist, or surgeon.

“Most individuals at high risk of opioid overdose do not receive naloxone through direct prescribing,” Ms. Follman and associates wrote. “Clinicians can address this gap by regularly prescribing naloxone to eligible patients. To address barriers to prescribing, hospital systems and medical schools can support clinicians by improving education on screening and treating substance use disorders, clarifying legal concerns, and developing policies and protocols to guide implementation of increased prescribing. “Health care systems can also create or strengthen processes to encourage naloxone prescribing.”

No conflicts of interest were reported; one coauthor reported receiving a grant from the National Institutes of Health.

[email protected]

SOURCE: Follman S et al. JAMA Netw Open. 2019 May 3. doi: 10.1001/jamanetworkopen.2019.3209.

The vast majority of individuals at high risk for opioid overdose do not receive naloxone, despite numerous opportunities, according to Sarah Follman and associates from the University of Chicago.

In a retrospective study published in JAMA Network Open, the study authors analyzed data from individuals in the Truven Health MarketScan Research Database who had ICD-10 codes related to opioid use, misuse, dependence, and overdose. Data from Oct. 1, 2015, through Dec. 31, 2016, were included; a total of 138,108 high-risk individuals were identified as interacting with the health care system nearly 1.2 million times (88,618 hospitalizations, 229,680 ED visits, 298,058 internal medicine visits, and 568,448 family practice visits).

Of the 138,108 individuals in the study, only 2,135 (1.5%) were prescribed naloxone during the study period. Patients who had prior diagnoses of both opioid misuse/dependence and overdose were significantly more likely to receive naloxone than were those who only had a history of opioid dependence (odds ratio, 2.32; 95% confidence interval, 1.98-2.72; P less than .001). In addition, having a history of overdose alone was associated with a decreased chance of receiving naloxone, compared with those with a history of opioid misuse alone (OR, 0.73; 95% CI, 0.57-0.94; P = .01).

Other factors that significantly reduced the odds of receiving naloxone included being aged 30-44 years and being from the Midwest or West. Factors that reduced the odds include having received treatment for opioid use disorder, visiting a detoxification facility, receiving other substance use disorder treatment; and having received outpatient care from a pain specialist, psychologist, or surgeon.

“Most individuals at high risk of opioid overdose do not receive naloxone through direct prescribing,” Ms. Follman and associates wrote. “Clinicians can address this gap by regularly prescribing naloxone to eligible patients. To address barriers to prescribing, hospital systems and medical schools can support clinicians by improving education on screening and treating substance use disorders, clarifying legal concerns, and developing policies and protocols to guide implementation of increased prescribing. “Health care systems can also create or strengthen processes to encourage naloxone prescribing.”

No conflicts of interest were reported; one coauthor reported receiving a grant from the National Institutes of Health.

[email protected]

SOURCE: Follman S et al. JAMA Netw Open. 2019 May 3. doi: 10.1001/jamanetworkopen.2019.3209.