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VIDEO: Celecoxib just as safe as naproxen or ibuprofen in OA and RA
WASHINGTON – Celecoxib conferred a 53% decreased risk of overall mortality upon patients with rheumatoid arthritis when compared with naproxen – a surprise finding in a subanalysis of the newly released PRECISION study of anti-inflammatory drugs in arthritis.
But it’s tough to know what to make of the difference, according to the investigators at the annual meeting of the American College of Rheumatology. Although statistically significant, the mortality finding was based on just 45 events: 30 among those taking naproxen and 15 among those taking celecoxib.
“While I would say we were surprised to see this, we really can’t say what it means – or if it means anything,” primary investigator Daniel Solomon, MD, said in an interview. “This is a finding we will continue to investigate and look at, but at this point it’s not enough to base any prescribing decisions on.”
PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) enrolled more than 24,000 patients with osteoarthritis or rheumatoid arthritis. They were randomized to celecoxib, naproxen, or ibuprofen for a mean of 20 months, with an additional mean follow-up of 34 months.
The primary outcome was the first occurrence of an adverse event from the Antiplatelet Trialists Collaboration criteria (APTC; death from cardiovascular causes, nonfatal heart attack, or nonfatal stroke). Secondary outcomes included:
• Major cardiovascular events (heart attack, stroke, cardiovascular death, revascularization, and hospitalization for unstable angina or transient ischemic attack).
• Renal events (acute kidney injury, including hospitalization for renal failure).
• Gastrointestinal events (hemorrhage, perforation, gastroduodenal ulcer, anemia of gastrointestinal origin, and gastric outlet obstruction.
The main PRECISION findings were released Nov. 13 at the annual meeting of the American Heart Association and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593).
Overall, celecoxib was just as safe as were the other drugs on the APTC endpoint, which occurred in about 2% of each groups. The study found significantly decreased risks of both GI and renal events with celecoxib, compared with either naproxen or ibuprofen. Celecoxib and naproxen were equivalent with regard to GI and renal events.
The subanalysis, released at the ACR meeting, adds important disease-specific context to the overall PRECISION results.
“We wanted to really delve into the subtle differences in how these two patient groups responded to these medications,” said PRECISION coinvestigator Elaine Husni, MD, vice chair of the department of rheumatic and immunologic diseases at the Cleveland Clinic.
“We learned that each of these NSAIDs has a unique safety profile that can be different in different groups. And in general, celecoxib seems less risky than the others.”
The cohort subanalysis broke down these endpoints among 21,600 patients with osteoarthritis and 2,400 with rheumatoid arthritis.
Among patients with osteoarthritis, celecoxib was also associated with a 16% decreased risk of a major adverse cardiovascular event, compared with ibuprofen. GI events were also less likely in this group: Celecoxib was associated with a 32% decreased risk, compared with ibuprofen, and a 27% decreased risk, compared with naproxen.
Renal outcomes were almost identical in all of the medications in both groups, Dr. Husni said.
In addition to the adverse event outcomes, the subanalysis examined how well patients responded to their assigned NSAID. There were also some subtle differences seen here, Dr. Solomon and Dr. Husni said.
For patients with RA, ibuprofen was slightly, but significantly, more effective than either celecoxib or ibuprofen at controlling pain as measured by a visual analog pain scale. Patients with osteoarthritis responded equally well to all of the drugs.
RA patients also responded best to ibuprofen as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Again, patients with osteoarthritis responded equally well to all of the medications.
The overall findings, as well as the subanalysis, should be reassuring to both physicians and patients, said Dr. Solomon, chief of the section of clinical sciences in the divisions of rheumatology and pharmacoepidemiology at Brigham and Women’s Hospital, Boston.
“I can now stand in front of patients and say with confidence, ‘Each of these drugs is fairly safe, and together we can choose the one that will be best for you, based on your own individual history and your own individual risk factors.’ I feel good about that.”
Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
WASHINGTON – Celecoxib conferred a 53% decreased risk of overall mortality upon patients with rheumatoid arthritis when compared with naproxen – a surprise finding in a subanalysis of the newly released PRECISION study of anti-inflammatory drugs in arthritis.
But it’s tough to know what to make of the difference, according to the investigators at the annual meeting of the American College of Rheumatology. Although statistically significant, the mortality finding was based on just 45 events: 30 among those taking naproxen and 15 among those taking celecoxib.
“While I would say we were surprised to see this, we really can’t say what it means – or if it means anything,” primary investigator Daniel Solomon, MD, said in an interview. “This is a finding we will continue to investigate and look at, but at this point it’s not enough to base any prescribing decisions on.”
PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) enrolled more than 24,000 patients with osteoarthritis or rheumatoid arthritis. They were randomized to celecoxib, naproxen, or ibuprofen for a mean of 20 months, with an additional mean follow-up of 34 months.
The primary outcome was the first occurrence of an adverse event from the Antiplatelet Trialists Collaboration criteria (APTC; death from cardiovascular causes, nonfatal heart attack, or nonfatal stroke). Secondary outcomes included:
• Major cardiovascular events (heart attack, stroke, cardiovascular death, revascularization, and hospitalization for unstable angina or transient ischemic attack).
• Renal events (acute kidney injury, including hospitalization for renal failure).
• Gastrointestinal events (hemorrhage, perforation, gastroduodenal ulcer, anemia of gastrointestinal origin, and gastric outlet obstruction.
The main PRECISION findings were released Nov. 13 at the annual meeting of the American Heart Association and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593).
Overall, celecoxib was just as safe as were the other drugs on the APTC endpoint, which occurred in about 2% of each groups. The study found significantly decreased risks of both GI and renal events with celecoxib, compared with either naproxen or ibuprofen. Celecoxib and naproxen were equivalent with regard to GI and renal events.
The subanalysis, released at the ACR meeting, adds important disease-specific context to the overall PRECISION results.
“We wanted to really delve into the subtle differences in how these two patient groups responded to these medications,” said PRECISION coinvestigator Elaine Husni, MD, vice chair of the department of rheumatic and immunologic diseases at the Cleveland Clinic.
“We learned that each of these NSAIDs has a unique safety profile that can be different in different groups. And in general, celecoxib seems less risky than the others.”
The cohort subanalysis broke down these endpoints among 21,600 patients with osteoarthritis and 2,400 with rheumatoid arthritis.
Among patients with osteoarthritis, celecoxib was also associated with a 16% decreased risk of a major adverse cardiovascular event, compared with ibuprofen. GI events were also less likely in this group: Celecoxib was associated with a 32% decreased risk, compared with ibuprofen, and a 27% decreased risk, compared with naproxen.
Renal outcomes were almost identical in all of the medications in both groups, Dr. Husni said.
In addition to the adverse event outcomes, the subanalysis examined how well patients responded to their assigned NSAID. There were also some subtle differences seen here, Dr. Solomon and Dr. Husni said.
For patients with RA, ibuprofen was slightly, but significantly, more effective than either celecoxib or ibuprofen at controlling pain as measured by a visual analog pain scale. Patients with osteoarthritis responded equally well to all of the drugs.
RA patients also responded best to ibuprofen as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Again, patients with osteoarthritis responded equally well to all of the medications.
The overall findings, as well as the subanalysis, should be reassuring to both physicians and patients, said Dr. Solomon, chief of the section of clinical sciences in the divisions of rheumatology and pharmacoepidemiology at Brigham and Women’s Hospital, Boston.
“I can now stand in front of patients and say with confidence, ‘Each of these drugs is fairly safe, and together we can choose the one that will be best for you, based on your own individual history and your own individual risk factors.’ I feel good about that.”
Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
WASHINGTON – Celecoxib conferred a 53% decreased risk of overall mortality upon patients with rheumatoid arthritis when compared with naproxen – a surprise finding in a subanalysis of the newly released PRECISION study of anti-inflammatory drugs in arthritis.
But it’s tough to know what to make of the difference, according to the investigators at the annual meeting of the American College of Rheumatology. Although statistically significant, the mortality finding was based on just 45 events: 30 among those taking naproxen and 15 among those taking celecoxib.
“While I would say we were surprised to see this, we really can’t say what it means – or if it means anything,” primary investigator Daniel Solomon, MD, said in an interview. “This is a finding we will continue to investigate and look at, but at this point it’s not enough to base any prescribing decisions on.”
PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) enrolled more than 24,000 patients with osteoarthritis or rheumatoid arthritis. They were randomized to celecoxib, naproxen, or ibuprofen for a mean of 20 months, with an additional mean follow-up of 34 months.
The primary outcome was the first occurrence of an adverse event from the Antiplatelet Trialists Collaboration criteria (APTC; death from cardiovascular causes, nonfatal heart attack, or nonfatal stroke). Secondary outcomes included:
• Major cardiovascular events (heart attack, stroke, cardiovascular death, revascularization, and hospitalization for unstable angina or transient ischemic attack).
• Renal events (acute kidney injury, including hospitalization for renal failure).
• Gastrointestinal events (hemorrhage, perforation, gastroduodenal ulcer, anemia of gastrointestinal origin, and gastric outlet obstruction.
The main PRECISION findings were released Nov. 13 at the annual meeting of the American Heart Association and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593).
Overall, celecoxib was just as safe as were the other drugs on the APTC endpoint, which occurred in about 2% of each groups. The study found significantly decreased risks of both GI and renal events with celecoxib, compared with either naproxen or ibuprofen. Celecoxib and naproxen were equivalent with regard to GI and renal events.
The subanalysis, released at the ACR meeting, adds important disease-specific context to the overall PRECISION results.
“We wanted to really delve into the subtle differences in how these two patient groups responded to these medications,” said PRECISION coinvestigator Elaine Husni, MD, vice chair of the department of rheumatic and immunologic diseases at the Cleveland Clinic.
“We learned that each of these NSAIDs has a unique safety profile that can be different in different groups. And in general, celecoxib seems less risky than the others.”
The cohort subanalysis broke down these endpoints among 21,600 patients with osteoarthritis and 2,400 with rheumatoid arthritis.
Among patients with osteoarthritis, celecoxib was also associated with a 16% decreased risk of a major adverse cardiovascular event, compared with ibuprofen. GI events were also less likely in this group: Celecoxib was associated with a 32% decreased risk, compared with ibuprofen, and a 27% decreased risk, compared with naproxen.
Renal outcomes were almost identical in all of the medications in both groups, Dr. Husni said.
In addition to the adverse event outcomes, the subanalysis examined how well patients responded to their assigned NSAID. There were also some subtle differences seen here, Dr. Solomon and Dr. Husni said.
For patients with RA, ibuprofen was slightly, but significantly, more effective than either celecoxib or ibuprofen at controlling pain as measured by a visual analog pain scale. Patients with osteoarthritis responded equally well to all of the drugs.
RA patients also responded best to ibuprofen as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Again, patients with osteoarthritis responded equally well to all of the medications.
The overall findings, as well as the subanalysis, should be reassuring to both physicians and patients, said Dr. Solomon, chief of the section of clinical sciences in the divisions of rheumatology and pharmacoepidemiology at Brigham and Women’s Hospital, Boston.
“I can now stand in front of patients and say with confidence, ‘Each of these drugs is fairly safe, and together we can choose the one that will be best for you, based on your own individual history and your own individual risk factors.’ I feel good about that.”
Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
AT THE ACR ANNUAL MEETING
Key clinical point:
Major finding: Compared with naproxen, celecoxib was associated with a 53% lower risk of overall mortality, although the clinical impact of that finding remains unknown.
Data source: PRECISION, which randomized more than 24,000 patients to celecoxib, ibuprofen, or naproxen.
Disclosures: Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
No primary prevention gains from low-dose aspirin in diabetes
Low-dose aspirin does not appear to reduce the risk of cardiovascular events in individuals with type 2 diabetes but without preexisting cardiovascular disease, according to a study presented at the American Heart Association scientific sessions and published simultaneously in the Nov. 15 edition of Circulation.
In the long-term follow-up of participants in an open-label controlled trial, Japanese researchers followed 2,539 patients with type 2 diabetes who were randomized to daily aspirin (81 mg or 100 mg) or no aspirin, for a median of 10.3 years to see the impact on the incidence of cardiovascular events.
In their study, they found that a daily regimen of low-dose aspirin was not associated with a significant change in the risk of cardiovascular events including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). They also found no significant difference between the two groups in secondary outcomes, which were a composite of coronary artery, cerebrovascular, and vascular events.
This lack of impact persisted even after age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia were accounted for, and it was also seen in sensitivity analyses on the intention-to-treat cohort.
However, the investigators did find a significantly higher rate of gastrointestinal bleeding in patients taking aspirin, compared with the control group (2% vs. 0.9%, P = .03) but no difference in the rate of hemorrhagic stroke.
“Meta-analyses in patients with diabetes have reported that aspirin has a smaller benefit for primary prevention than in general populations, although patients with diabetes are at high risk for cardiovascular events,” the authors wrote. “It seems there are differential effects of low-dose aspirin therapy on preventing cardiovascular events in patients with and without diabetes.”
The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
Low-dose aspirin does not appear to reduce the risk of cardiovascular events in individuals with type 2 diabetes but without preexisting cardiovascular disease, according to a study presented at the American Heart Association scientific sessions and published simultaneously in the Nov. 15 edition of Circulation.
In the long-term follow-up of participants in an open-label controlled trial, Japanese researchers followed 2,539 patients with type 2 diabetes who were randomized to daily aspirin (81 mg or 100 mg) or no aspirin, for a median of 10.3 years to see the impact on the incidence of cardiovascular events.
In their study, they found that a daily regimen of low-dose aspirin was not associated with a significant change in the risk of cardiovascular events including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). They also found no significant difference between the two groups in secondary outcomes, which were a composite of coronary artery, cerebrovascular, and vascular events.
This lack of impact persisted even after age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia were accounted for, and it was also seen in sensitivity analyses on the intention-to-treat cohort.
However, the investigators did find a significantly higher rate of gastrointestinal bleeding in patients taking aspirin, compared with the control group (2% vs. 0.9%, P = .03) but no difference in the rate of hemorrhagic stroke.
“Meta-analyses in patients with diabetes have reported that aspirin has a smaller benefit for primary prevention than in general populations, although patients with diabetes are at high risk for cardiovascular events,” the authors wrote. “It seems there are differential effects of low-dose aspirin therapy on preventing cardiovascular events in patients with and without diabetes.”
The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
Low-dose aspirin does not appear to reduce the risk of cardiovascular events in individuals with type 2 diabetes but without preexisting cardiovascular disease, according to a study presented at the American Heart Association scientific sessions and published simultaneously in the Nov. 15 edition of Circulation.
In the long-term follow-up of participants in an open-label controlled trial, Japanese researchers followed 2,539 patients with type 2 diabetes who were randomized to daily aspirin (81 mg or 100 mg) or no aspirin, for a median of 10.3 years to see the impact on the incidence of cardiovascular events.
In their study, they found that a daily regimen of low-dose aspirin was not associated with a significant change in the risk of cardiovascular events including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). They also found no significant difference between the two groups in secondary outcomes, which were a composite of coronary artery, cerebrovascular, and vascular events.
This lack of impact persisted even after age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia were accounted for, and it was also seen in sensitivity analyses on the intention-to-treat cohort.
However, the investigators did find a significantly higher rate of gastrointestinal bleeding in patients taking aspirin, compared with the control group (2% vs. 0.9%, P = .03) but no difference in the rate of hemorrhagic stroke.
“Meta-analyses in patients with diabetes have reported that aspirin has a smaller benefit for primary prevention than in general populations, although patients with diabetes are at high risk for cardiovascular events,” the authors wrote. “It seems there are differential effects of low-dose aspirin therapy on preventing cardiovascular events in patients with and without diabetes.”
The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Patients with type 2 diabetes taking daily low-dose aspirin showed no significant reductions in cardiovascular events, compared with a control group not taking aspirin.
Data source: Long-term follow-up in a randomized controlled trial in 2,539 patients with type 2 diabetes in the absence of preexisting cardiovascular disease.
Disclosures: The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
Moises Auron, MD, SFHM, leverages his SHM membership to engage students in hospital medicine
Editor’s note: As SHM celebrates the “Year of the Hospitalist,” we’re putting the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Log on to www.hospitalmedicine.org/yoth for more information on how you can join the yearlong celebration and help SHM improve the care of hospitalized patients.
This month, The Hospitalist spotlights Moises Auron, MD, SFHM, a dual internal medicine/pediatrics hospitalist at the Cleveland Clinic. He is board certified in internal medicine and pediatrics and serves as associate professor of medicine and pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Question: What inspired you to begin working in hospital medicine and later join SHM?
Answer: I joined SHM as a third-year med-peds resident, influenced by my mentor and teacher, Dr. James C. Pile. I completed my medicine and perioperative consult rotation with him, and it was the first time in ages that anybody had served as such a motivating role model. He gave me a collection of The Hospitalist newsmagazines focused on perioperative medicine as well as a pack of articles around pertinent subjects for an internal medicine consultation service. It was a breath of fresh air; I found an entirely new niche in medicine. And in addition, he demonstrated to me how being a hospitalist was a fundamental pillar of patient care within the healthcare system. He showed me the elements of a thorough and pertinent system-based practice.
I met SHM CEO Dr. Larry Wellikson and the SHM team during a meeting in Philadelphia about 10 years ago and became even more acquainted with the society and its goals. I became a member on the spot. As a resident, I loved receiving both The Hospitalist and the Journal of Hospital Medicine. Both helped me also in my initial job search during my senior year of residency as well as with familiarizing myself with the latest hospital medicine literature. In short, being a member of SHM helped me cement my professional career path to hospital medicine.
Q: How has SHM provided you with resources to improve patient care and further your career?
I had the privilege of attending the Academic Hospitalist Academy and the Quality and Safety Educators Academy as well; both have helped me foster further goals in my career as well as achieve substantial professional and personal satisfaction.
The most important aspect of my membership has been becoming acquainted with a tremendous group of talented human beings, including both the SHM staff as well as hospitalist colleagues. The strength of SHM is its people: passionate providers and administrators who aim to make a better world for patients and doctors.
Q: What is your proudest moment working in hospital medicine?
A: Every single day of my job. As an academic hospitalist and a quality officer at my institution, I take tremendous pride in my job. I define ourselves as the super-internists; we are a quaternary medical center that cares for patients referred from all over the nation, and we need to elucidate obscure diagnoses and aim to offer a treatment and hope.
To me, what is more important is when I witness my residents being actively mindful about preventing harm: when they hardwire best practices such as good hand hygiene, precautions for prevention of falls, risk mitigation associated with any medical intervention … The list goes on. When I appreciate that behavior that becomes my proudest moment because I know that they will ensure the best outcomes for our patients and that I have made an impact.
Q: What do you see as the biggest opportunity for hospitalists as healthcare continues to evolve, and how can hospitalists rise to the challenge?
A: As the saying goes, “One of the tests of leadership is the ability to recognize a problem before it becomes an emergency.” We need to anticipate the way American healthcare is being delivered. The business model is changing, and the payment system is transitioning. Quality is being leveraged as a tool to decrease costs of care.
Hospitalists need to be creative in capitalizing on each individual patient encounter to maximize communication with other members of the healthcare team and use the patient’s hospitalization time strategically. We need to be the savings experts. We can recognize areas where unnecessary expenditure is used by having a lean mind and focusing on removing waste that will not impact our patients. We are the experts on the front line—we need to share the feedback to the leadership.
Q: What advice would you give to future providers considering a career in hospital medicine?
A: Become an SHM member early in your residency, aim to present a poster, participate at an SHM meeting, and engage in the networking process. SHM offers educational initiatives (e.g., Leadership Academy, Academic Hospitalist Academy, Quality and Safety Educators Academy), quality improvement programs (e.g., BOOST and Glycemic Control), and educational content to ensure your success in the Focused Practice in Hospital Medicine exam via the SHM SPARK tool.
Why so early? Because all of these resources help to build a sense of purpose and help to answer the question, “Where do I want to be five years from now?” Networking is fundamental, especially as it gives the opportunity to develop potential mentorship relationships and create teams for future collaboration endeavors.
Editor’s note: As SHM celebrates the “Year of the Hospitalist,” we’re putting the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Log on to www.hospitalmedicine.org/yoth for more information on how you can join the yearlong celebration and help SHM improve the care of hospitalized patients.
This month, The Hospitalist spotlights Moises Auron, MD, SFHM, a dual internal medicine/pediatrics hospitalist at the Cleveland Clinic. He is board certified in internal medicine and pediatrics and serves as associate professor of medicine and pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Question: What inspired you to begin working in hospital medicine and later join SHM?
Answer: I joined SHM as a third-year med-peds resident, influenced by my mentor and teacher, Dr. James C. Pile. I completed my medicine and perioperative consult rotation with him, and it was the first time in ages that anybody had served as such a motivating role model. He gave me a collection of The Hospitalist newsmagazines focused on perioperative medicine as well as a pack of articles around pertinent subjects for an internal medicine consultation service. It was a breath of fresh air; I found an entirely new niche in medicine. And in addition, he demonstrated to me how being a hospitalist was a fundamental pillar of patient care within the healthcare system. He showed me the elements of a thorough and pertinent system-based practice.
I met SHM CEO Dr. Larry Wellikson and the SHM team during a meeting in Philadelphia about 10 years ago and became even more acquainted with the society and its goals. I became a member on the spot. As a resident, I loved receiving both The Hospitalist and the Journal of Hospital Medicine. Both helped me also in my initial job search during my senior year of residency as well as with familiarizing myself with the latest hospital medicine literature. In short, being a member of SHM helped me cement my professional career path to hospital medicine.
Q: How has SHM provided you with resources to improve patient care and further your career?
I had the privilege of attending the Academic Hospitalist Academy and the Quality and Safety Educators Academy as well; both have helped me foster further goals in my career as well as achieve substantial professional and personal satisfaction.
The most important aspect of my membership has been becoming acquainted with a tremendous group of talented human beings, including both the SHM staff as well as hospitalist colleagues. The strength of SHM is its people: passionate providers and administrators who aim to make a better world for patients and doctors.
Q: What is your proudest moment working in hospital medicine?
A: Every single day of my job. As an academic hospitalist and a quality officer at my institution, I take tremendous pride in my job. I define ourselves as the super-internists; we are a quaternary medical center that cares for patients referred from all over the nation, and we need to elucidate obscure diagnoses and aim to offer a treatment and hope.
To me, what is more important is when I witness my residents being actively mindful about preventing harm: when they hardwire best practices such as good hand hygiene, precautions for prevention of falls, risk mitigation associated with any medical intervention … The list goes on. When I appreciate that behavior that becomes my proudest moment because I know that they will ensure the best outcomes for our patients and that I have made an impact.
Q: What do you see as the biggest opportunity for hospitalists as healthcare continues to evolve, and how can hospitalists rise to the challenge?
A: As the saying goes, “One of the tests of leadership is the ability to recognize a problem before it becomes an emergency.” We need to anticipate the way American healthcare is being delivered. The business model is changing, and the payment system is transitioning. Quality is being leveraged as a tool to decrease costs of care.
Hospitalists need to be creative in capitalizing on each individual patient encounter to maximize communication with other members of the healthcare team and use the patient’s hospitalization time strategically. We need to be the savings experts. We can recognize areas where unnecessary expenditure is used by having a lean mind and focusing on removing waste that will not impact our patients. We are the experts on the front line—we need to share the feedback to the leadership.
Q: What advice would you give to future providers considering a career in hospital medicine?
A: Become an SHM member early in your residency, aim to present a poster, participate at an SHM meeting, and engage in the networking process. SHM offers educational initiatives (e.g., Leadership Academy, Academic Hospitalist Academy, Quality and Safety Educators Academy), quality improvement programs (e.g., BOOST and Glycemic Control), and educational content to ensure your success in the Focused Practice in Hospital Medicine exam via the SHM SPARK tool.
Why so early? Because all of these resources help to build a sense of purpose and help to answer the question, “Where do I want to be five years from now?” Networking is fundamental, especially as it gives the opportunity to develop potential mentorship relationships and create teams for future collaboration endeavors.
Editor’s note: As SHM celebrates the “Year of the Hospitalist,” we’re putting the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Log on to www.hospitalmedicine.org/yoth for more information on how you can join the yearlong celebration and help SHM improve the care of hospitalized patients.
This month, The Hospitalist spotlights Moises Auron, MD, SFHM, a dual internal medicine/pediatrics hospitalist at the Cleveland Clinic. He is board certified in internal medicine and pediatrics and serves as associate professor of medicine and pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Question: What inspired you to begin working in hospital medicine and later join SHM?
Answer: I joined SHM as a third-year med-peds resident, influenced by my mentor and teacher, Dr. James C. Pile. I completed my medicine and perioperative consult rotation with him, and it was the first time in ages that anybody had served as such a motivating role model. He gave me a collection of The Hospitalist newsmagazines focused on perioperative medicine as well as a pack of articles around pertinent subjects for an internal medicine consultation service. It was a breath of fresh air; I found an entirely new niche in medicine. And in addition, he demonstrated to me how being a hospitalist was a fundamental pillar of patient care within the healthcare system. He showed me the elements of a thorough and pertinent system-based practice.
I met SHM CEO Dr. Larry Wellikson and the SHM team during a meeting in Philadelphia about 10 years ago and became even more acquainted with the society and its goals. I became a member on the spot. As a resident, I loved receiving both The Hospitalist and the Journal of Hospital Medicine. Both helped me also in my initial job search during my senior year of residency as well as with familiarizing myself with the latest hospital medicine literature. In short, being a member of SHM helped me cement my professional career path to hospital medicine.
Q: How has SHM provided you with resources to improve patient care and further your career?
I had the privilege of attending the Academic Hospitalist Academy and the Quality and Safety Educators Academy as well; both have helped me foster further goals in my career as well as achieve substantial professional and personal satisfaction.
The most important aspect of my membership has been becoming acquainted with a tremendous group of talented human beings, including both the SHM staff as well as hospitalist colleagues. The strength of SHM is its people: passionate providers and administrators who aim to make a better world for patients and doctors.
Q: What is your proudest moment working in hospital medicine?
A: Every single day of my job. As an academic hospitalist and a quality officer at my institution, I take tremendous pride in my job. I define ourselves as the super-internists; we are a quaternary medical center that cares for patients referred from all over the nation, and we need to elucidate obscure diagnoses and aim to offer a treatment and hope.
To me, what is more important is when I witness my residents being actively mindful about preventing harm: when they hardwire best practices such as good hand hygiene, precautions for prevention of falls, risk mitigation associated with any medical intervention … The list goes on. When I appreciate that behavior that becomes my proudest moment because I know that they will ensure the best outcomes for our patients and that I have made an impact.
Q: What do you see as the biggest opportunity for hospitalists as healthcare continues to evolve, and how can hospitalists rise to the challenge?
A: As the saying goes, “One of the tests of leadership is the ability to recognize a problem before it becomes an emergency.” We need to anticipate the way American healthcare is being delivered. The business model is changing, and the payment system is transitioning. Quality is being leveraged as a tool to decrease costs of care.
Hospitalists need to be creative in capitalizing on each individual patient encounter to maximize communication with other members of the healthcare team and use the patient’s hospitalization time strategically. We need to be the savings experts. We can recognize areas where unnecessary expenditure is used by having a lean mind and focusing on removing waste that will not impact our patients. We are the experts on the front line—we need to share the feedback to the leadership.
Q: What advice would you give to future providers considering a career in hospital medicine?
A: Become an SHM member early in your residency, aim to present a poster, participate at an SHM meeting, and engage in the networking process. SHM offers educational initiatives (e.g., Leadership Academy, Academic Hospitalist Academy, Quality and Safety Educators Academy), quality improvement programs (e.g., BOOST and Glycemic Control), and educational content to ensure your success in the Focused Practice in Hospital Medicine exam via the SHM SPARK tool.
Why so early? Because all of these resources help to build a sense of purpose and help to answer the question, “Where do I want to be five years from now?” Networking is fundamental, especially as it gives the opportunity to develop potential mentorship relationships and create teams for future collaboration endeavors.
Six Open Clinical Trials That Are Expanding Our Understanding of Immunotherapies
Using the immune system to help fight cancer is one of newest and most promising directions in cancer research. While many of the findings so far remain preliminary, a number of new studies are being developed or are already underway. Not surprisingly, federal oncologists and hematologists are leading the way with ground-breaking research. Importantly, a number of trials are recruiting patients at VA facilities. Here are a few of the studies already underway:
Study: Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Sponsor: National Cancer Institute
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Federal Study Locations (7 total): Kansas City VAMC
Study: Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Sponsor: National Cancer Institute
This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well these drugs work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Federal Study Locations (311 total): Little Rock (Arkansas) VAMC
Study: Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma (NCT01169337)
Sponsor: National Cancer Institute
This randomized phase II/III trial studies how well lenalidomide works in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
Federal Study Locations (600 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT02143414)
Sponsor: National Cancer Institute
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or halting the cells’ ability to spread. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Federal Study Locations (180 total): Little Rock (Arkansas) VAMC
Study: Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT01415752)
Sponsor: Eastern Cooperative Oncology Group
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
Federal Study Locations (426 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (NCT01856192)
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.
Federal Study Locations (511 total): Little Rock (Arkansas) VAMC
Using the immune system to help fight cancer is one of newest and most promising directions in cancer research. While many of the findings so far remain preliminary, a number of new studies are being developed or are already underway. Not surprisingly, federal oncologists and hematologists are leading the way with ground-breaking research. Importantly, a number of trials are recruiting patients at VA facilities. Here are a few of the studies already underway:
Study: Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Sponsor: National Cancer Institute
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Federal Study Locations (7 total): Kansas City VAMC
Study: Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Sponsor: National Cancer Institute
This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well these drugs work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Federal Study Locations (311 total): Little Rock (Arkansas) VAMC
Study: Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma (NCT01169337)
Sponsor: National Cancer Institute
This randomized phase II/III trial studies how well lenalidomide works in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
Federal Study Locations (600 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT02143414)
Sponsor: National Cancer Institute
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or halting the cells’ ability to spread. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Federal Study Locations (180 total): Little Rock (Arkansas) VAMC
Study: Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT01415752)
Sponsor: Eastern Cooperative Oncology Group
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
Federal Study Locations (426 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (NCT01856192)
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.
Federal Study Locations (511 total): Little Rock (Arkansas) VAMC
Using the immune system to help fight cancer is one of newest and most promising directions in cancer research. While many of the findings so far remain preliminary, a number of new studies are being developed or are already underway. Not surprisingly, federal oncologists and hematologists are leading the way with ground-breaking research. Importantly, a number of trials are recruiting patients at VA facilities. Here are a few of the studies already underway:
Study: Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Sponsor: National Cancer Institute
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Federal Study Locations (7 total): Kansas City VAMC
Study: Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Sponsor: National Cancer Institute
This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well these drugs work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Federal Study Locations (311 total): Little Rock (Arkansas) VAMC
Study: Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma (NCT01169337)
Sponsor: National Cancer Institute
This randomized phase II/III trial studies how well lenalidomide works in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
Federal Study Locations (600 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT02143414)
Sponsor: National Cancer Institute
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or halting the cells’ ability to spread. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Federal Study Locations (180 total): Little Rock (Arkansas) VAMC
Study: Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT01415752)
Sponsor: Eastern Cooperative Oncology Group
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
Federal Study Locations (426 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (NCT01856192)
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.
Federal Study Locations (511 total): Little Rock (Arkansas) VAMC
MRI detects early stages of MF in mice
Magnetic resonance imaging (MRI) can effectively detect myelofibrosis (MF) in a mouse model, according to research published in the journal Blood Cancer.
In fact, researchers found that MRI could detect early and late stages of primary MF.
The researchers believe this discovery could potentially change the way MF is diagnosed, as MRI might be used to help physicians decide if or where to biopsy.
Katya Ravid, PhD, of Boston University School of Medicine in Massachusetts, and her colleagues conducted this research, aiming to determine whether T2-weighted MRI could detect bone marrow fibrosis in a mouse model of primary MF.
The team looked specifically at how effectively MRI could detect MF during the pre-fibrotic stage (when mice were less than 16 weeks old), when the mice had early MF (16 to 36 weeks old), and once the mice had overt MF (older than 36 weeks).
The researchers found that MRI could detect MF at the pre-fibrotic stage as well as detecting progressive MF.
The team said they observed a clear, bright signal that allowed them to differentiate mice with MF from healthy control mice.
The researchers proposed that the abundance of large megakaryocytes contributed to the bright signal they observed, since, in T2-weighted MR images, increased water/proton content, as in increased cellularity, yields high MR-signal intensity.
The team said this study provides proof of concept that T2-weighted MRI can detect primary MF in the early and late stages.
Magnetic resonance imaging (MRI) can effectively detect myelofibrosis (MF) in a mouse model, according to research published in the journal Blood Cancer.
In fact, researchers found that MRI could detect early and late stages of primary MF.
The researchers believe this discovery could potentially change the way MF is diagnosed, as MRI might be used to help physicians decide if or where to biopsy.
Katya Ravid, PhD, of Boston University School of Medicine in Massachusetts, and her colleagues conducted this research, aiming to determine whether T2-weighted MRI could detect bone marrow fibrosis in a mouse model of primary MF.
The team looked specifically at how effectively MRI could detect MF during the pre-fibrotic stage (when mice were less than 16 weeks old), when the mice had early MF (16 to 36 weeks old), and once the mice had overt MF (older than 36 weeks).
The researchers found that MRI could detect MF at the pre-fibrotic stage as well as detecting progressive MF.
The team said they observed a clear, bright signal that allowed them to differentiate mice with MF from healthy control mice.
The researchers proposed that the abundance of large megakaryocytes contributed to the bright signal they observed, since, in T2-weighted MR images, increased water/proton content, as in increased cellularity, yields high MR-signal intensity.
The team said this study provides proof of concept that T2-weighted MRI can detect primary MF in the early and late stages.
Magnetic resonance imaging (MRI) can effectively detect myelofibrosis (MF) in a mouse model, according to research published in the journal Blood Cancer.
In fact, researchers found that MRI could detect early and late stages of primary MF.
The researchers believe this discovery could potentially change the way MF is diagnosed, as MRI might be used to help physicians decide if or where to biopsy.
Katya Ravid, PhD, of Boston University School of Medicine in Massachusetts, and her colleagues conducted this research, aiming to determine whether T2-weighted MRI could detect bone marrow fibrosis in a mouse model of primary MF.
The team looked specifically at how effectively MRI could detect MF during the pre-fibrotic stage (when mice were less than 16 weeks old), when the mice had early MF (16 to 36 weeks old), and once the mice had overt MF (older than 36 weeks).
The researchers found that MRI could detect MF at the pre-fibrotic stage as well as detecting progressive MF.
The team said they observed a clear, bright signal that allowed them to differentiate mice with MF from healthy control mice.
The researchers proposed that the abundance of large megakaryocytes contributed to the bright signal they observed, since, in T2-weighted MR images, increased water/proton content, as in increased cellularity, yields high MR-signal intensity.
The team said this study provides proof of concept that T2-weighted MRI can detect primary MF in the early and late stages.
Antiplatelet drugs produce similar results in PAD
Photo from AstraZeneca
NEW ORLEANS—Results of the EUCLID trial suggest ticagrelor does not a provide a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD).
The incidence of atherothrombotic events was similar in patients who received ticagrelor and those who received clopidogrel.
Likewise, there was no significant difference between the treatment arms with regard to major bleeding.
Manesh R. Patel, MD, of Duke University Medical Center in Durham, North Carolina, presented results from the EUCLID trial at the American Heart Association Scientific Sessions.
Results were also published in NEJM. The trial was supported by AstraZeneca.
EUCLID included 13,885 patients with symptomatic PAD. They had median age of 66, and 72% were male.
The patients were randomized to receive ticagrelor at 90 mg twice daily or clopidogrel at 75 mg once daily.
The study’s primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, and ischemic stroke.
At a median follow-up of 30 months, the primary efficacy endpoint had occurred in 10.8% (751/6930) of patients in the ticagrelor arm and 10.6% (740/6955) in the clopidogrel arm (P=0.65).
When the researchers assessed each of the components of the primary endpoint alone, they found a significant difference between the treatment groups in the incidence of ischemic stroke but not cardiovascular death or myocardial infarction.
Cardiovascular death occurred in 5.2% of patients in the ticagrelor arm and 4.9% of those in the clopidogrel arm (P=0.40). Myocardial infarction occurred in 5% and 4.8%, respectively (P=0.48). And ischemic stroke occurred in 1.9% and 2.4%, respectively (P=0.03).
The study’s primary safety endpoint was major bleeding, which occurred in 1.6% of patients in both treatment arms (P=0.49).
Fatal bleeding occurred in 0.1% of patients in the ticagrelor arm and 0.3% of patients in the clopidogrel arm (P=0.10). And intracranial bleeding occurred in 0.5% of patients in both arms (P=0.82).
However, significantly more patients discontinued ticagrelor due to bleeding—2.4%, compared to 1.6% of patients who discontinued clopidogrel due to bleeding (P<0.001).
Significantly more patients discontinued ticagrelor due to dyspnea as well—4.8% vs 0.8% (P<0.001).
In all, 30.1% of patients in the ticagrelor arm and 25.9% of those in the clopidogrel arm prematurely discontinued treatment. This includes patients who discontinued due to adverse events, meeting the primary efficacy endpoint, and death.
Photo from AstraZeneca
NEW ORLEANS—Results of the EUCLID trial suggest ticagrelor does not a provide a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD).
The incidence of atherothrombotic events was similar in patients who received ticagrelor and those who received clopidogrel.
Likewise, there was no significant difference between the treatment arms with regard to major bleeding.
Manesh R. Patel, MD, of Duke University Medical Center in Durham, North Carolina, presented results from the EUCLID trial at the American Heart Association Scientific Sessions.
Results were also published in NEJM. The trial was supported by AstraZeneca.
EUCLID included 13,885 patients with symptomatic PAD. They had median age of 66, and 72% were male.
The patients were randomized to receive ticagrelor at 90 mg twice daily or clopidogrel at 75 mg once daily.
The study’s primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, and ischemic stroke.
At a median follow-up of 30 months, the primary efficacy endpoint had occurred in 10.8% (751/6930) of patients in the ticagrelor arm and 10.6% (740/6955) in the clopidogrel arm (P=0.65).
When the researchers assessed each of the components of the primary endpoint alone, they found a significant difference between the treatment groups in the incidence of ischemic stroke but not cardiovascular death or myocardial infarction.
Cardiovascular death occurred in 5.2% of patients in the ticagrelor arm and 4.9% of those in the clopidogrel arm (P=0.40). Myocardial infarction occurred in 5% and 4.8%, respectively (P=0.48). And ischemic stroke occurred in 1.9% and 2.4%, respectively (P=0.03).
The study’s primary safety endpoint was major bleeding, which occurred in 1.6% of patients in both treatment arms (P=0.49).
Fatal bleeding occurred in 0.1% of patients in the ticagrelor arm and 0.3% of patients in the clopidogrel arm (P=0.10). And intracranial bleeding occurred in 0.5% of patients in both arms (P=0.82).
However, significantly more patients discontinued ticagrelor due to bleeding—2.4%, compared to 1.6% of patients who discontinued clopidogrel due to bleeding (P<0.001).
Significantly more patients discontinued ticagrelor due to dyspnea as well—4.8% vs 0.8% (P<0.001).
In all, 30.1% of patients in the ticagrelor arm and 25.9% of those in the clopidogrel arm prematurely discontinued treatment. This includes patients who discontinued due to adverse events, meeting the primary efficacy endpoint, and death.
Photo from AstraZeneca
NEW ORLEANS—Results of the EUCLID trial suggest ticagrelor does not a provide a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD).
The incidence of atherothrombotic events was similar in patients who received ticagrelor and those who received clopidogrel.
Likewise, there was no significant difference between the treatment arms with regard to major bleeding.
Manesh R. Patel, MD, of Duke University Medical Center in Durham, North Carolina, presented results from the EUCLID trial at the American Heart Association Scientific Sessions.
Results were also published in NEJM. The trial was supported by AstraZeneca.
EUCLID included 13,885 patients with symptomatic PAD. They had median age of 66, and 72% were male.
The patients were randomized to receive ticagrelor at 90 mg twice daily or clopidogrel at 75 mg once daily.
The study’s primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, and ischemic stroke.
At a median follow-up of 30 months, the primary efficacy endpoint had occurred in 10.8% (751/6930) of patients in the ticagrelor arm and 10.6% (740/6955) in the clopidogrel arm (P=0.65).
When the researchers assessed each of the components of the primary endpoint alone, they found a significant difference between the treatment groups in the incidence of ischemic stroke but not cardiovascular death or myocardial infarction.
Cardiovascular death occurred in 5.2% of patients in the ticagrelor arm and 4.9% of those in the clopidogrel arm (P=0.40). Myocardial infarction occurred in 5% and 4.8%, respectively (P=0.48). And ischemic stroke occurred in 1.9% and 2.4%, respectively (P=0.03).
The study’s primary safety endpoint was major bleeding, which occurred in 1.6% of patients in both treatment arms (P=0.49).
Fatal bleeding occurred in 0.1% of patients in the ticagrelor arm and 0.3% of patients in the clopidogrel arm (P=0.10). And intracranial bleeding occurred in 0.5% of patients in both arms (P=0.82).
However, significantly more patients discontinued ticagrelor due to bleeding—2.4%, compared to 1.6% of patients who discontinued clopidogrel due to bleeding (P<0.001).
Significantly more patients discontinued ticagrelor due to dyspnea as well—4.8% vs 0.8% (P<0.001).
In all, 30.1% of patients in the ticagrelor arm and 25.9% of those in the clopidogrel arm prematurely discontinued treatment. This includes patients who discontinued due to adverse events, meeting the primary efficacy endpoint, and death.
FDA grants priority review for midostaurin
The US Food and Drug Administration (FDA) has granted priority review for the new drug application for midostaurin (PKC412) as a treatment for advanced systemic mastocytosis (SM) and newly diagnosed, FLT3-mutated acute myeloid leukemia (AML).
The FDA has also accepted for review the premarket approval application for the midostaurin FLT3 companion diagnostic, which is designed to help identify patients who may have a FLT3 mutation and could potentially benefit from treatment with midostaurin.
Midostaurin is being developed by Novartis. The companion diagnostic is being developed by Novartis and Invivoscribe Technologies, Inc.
About priority review
The FDA grants priority review to applications for therapies that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it. The goal in the standard review process is to take action within 10 months.
About midostaurin
Midostaurin is an oral, multi-targeted kinase inhibitor. The drug was granted breakthrough therapy designation by the FDA earlier this year for newly diagnosed, FLT3-mutated AML.
According to Novartis, the new drug application submission for midostaurin includes data from the largest clinical trials conducted to date in advanced SM and newly diagnosed, FLT3-mutated AML.
Midostaurin in AML
In the phase 3 RATIFY trial, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in adults younger than 60 with FLT3-mutated AML. Results from this trial were presented at the 2015 ASH Annual Meeting.
Patients in the midostaurin arm experienced a statistically significant improvement in overall survival, with a 23% reduction in risk of death compared to the placebo arm (hazard ratio=0.77, P=0.0074).
There was no significant difference in the overall rate of grade 3 or higher hematologic and non-hematologic adverse events in midostaurin arm and the placebo arm. Similarly, there was no significant difference in treatment-related deaths between the arms.
Midostaurin in SM
Data from the phase 2 study of midostaurin in patients with advanced SM were published in NEJM in June.
The drug produced a 60% overall response rate, and the median duration of response was 24.1 months.
Fifty-six percent of patients required dose reductions due to toxic effects, but 32% of these patients were able to return to the starting dose of midostaurin.
Access to midostaurin
Since midostaurin remains investigational, both within the US and globally, Novartis opened a Global Individual Patient Program (compassionate use program) and, in the US, an Expanded Treatment Protocol, to provide access to midostaurin for eligible patients with newly diagnosed AML and advanced SM.
Physicians who want to request midostaurin for eligible patients can contact a Novartis medical representative in their respective countries. In the US, physicians can call 1-888-NOW-NOVA (1-888-669-6682) for more information.
The US Food and Drug Administration (FDA) has granted priority review for the new drug application for midostaurin (PKC412) as a treatment for advanced systemic mastocytosis (SM) and newly diagnosed, FLT3-mutated acute myeloid leukemia (AML).
The FDA has also accepted for review the premarket approval application for the midostaurin FLT3 companion diagnostic, which is designed to help identify patients who may have a FLT3 mutation and could potentially benefit from treatment with midostaurin.
Midostaurin is being developed by Novartis. The companion diagnostic is being developed by Novartis and Invivoscribe Technologies, Inc.
About priority review
The FDA grants priority review to applications for therapies that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it. The goal in the standard review process is to take action within 10 months.
About midostaurin
Midostaurin is an oral, multi-targeted kinase inhibitor. The drug was granted breakthrough therapy designation by the FDA earlier this year for newly diagnosed, FLT3-mutated AML.
According to Novartis, the new drug application submission for midostaurin includes data from the largest clinical trials conducted to date in advanced SM and newly diagnosed, FLT3-mutated AML.
Midostaurin in AML
In the phase 3 RATIFY trial, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in adults younger than 60 with FLT3-mutated AML. Results from this trial were presented at the 2015 ASH Annual Meeting.
Patients in the midostaurin arm experienced a statistically significant improvement in overall survival, with a 23% reduction in risk of death compared to the placebo arm (hazard ratio=0.77, P=0.0074).
There was no significant difference in the overall rate of grade 3 or higher hematologic and non-hematologic adverse events in midostaurin arm and the placebo arm. Similarly, there was no significant difference in treatment-related deaths between the arms.
Midostaurin in SM
Data from the phase 2 study of midostaurin in patients with advanced SM were published in NEJM in June.
The drug produced a 60% overall response rate, and the median duration of response was 24.1 months.
Fifty-six percent of patients required dose reductions due to toxic effects, but 32% of these patients were able to return to the starting dose of midostaurin.
Access to midostaurin
Since midostaurin remains investigational, both within the US and globally, Novartis opened a Global Individual Patient Program (compassionate use program) and, in the US, an Expanded Treatment Protocol, to provide access to midostaurin for eligible patients with newly diagnosed AML and advanced SM.
Physicians who want to request midostaurin for eligible patients can contact a Novartis medical representative in their respective countries. In the US, physicians can call 1-888-NOW-NOVA (1-888-669-6682) for more information.
The US Food and Drug Administration (FDA) has granted priority review for the new drug application for midostaurin (PKC412) as a treatment for advanced systemic mastocytosis (SM) and newly diagnosed, FLT3-mutated acute myeloid leukemia (AML).
The FDA has also accepted for review the premarket approval application for the midostaurin FLT3 companion diagnostic, which is designed to help identify patients who may have a FLT3 mutation and could potentially benefit from treatment with midostaurin.
Midostaurin is being developed by Novartis. The companion diagnostic is being developed by Novartis and Invivoscribe Technologies, Inc.
About priority review
The FDA grants priority review to applications for therapies that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it. The goal in the standard review process is to take action within 10 months.
About midostaurin
Midostaurin is an oral, multi-targeted kinase inhibitor. The drug was granted breakthrough therapy designation by the FDA earlier this year for newly diagnosed, FLT3-mutated AML.
According to Novartis, the new drug application submission for midostaurin includes data from the largest clinical trials conducted to date in advanced SM and newly diagnosed, FLT3-mutated AML.
Midostaurin in AML
In the phase 3 RATIFY trial, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in adults younger than 60 with FLT3-mutated AML. Results from this trial were presented at the 2015 ASH Annual Meeting.
Patients in the midostaurin arm experienced a statistically significant improvement in overall survival, with a 23% reduction in risk of death compared to the placebo arm (hazard ratio=0.77, P=0.0074).
There was no significant difference in the overall rate of grade 3 or higher hematologic and non-hematologic adverse events in midostaurin arm and the placebo arm. Similarly, there was no significant difference in treatment-related deaths between the arms.
Midostaurin in SM
Data from the phase 2 study of midostaurin in patients with advanced SM were published in NEJM in June.
The drug produced a 60% overall response rate, and the median duration of response was 24.1 months.
Fifty-six percent of patients required dose reductions due to toxic effects, but 32% of these patients were able to return to the starting dose of midostaurin.
Access to midostaurin
Since midostaurin remains investigational, both within the US and globally, Novartis opened a Global Individual Patient Program (compassionate use program) and, in the US, an Expanded Treatment Protocol, to provide access to midostaurin for eligible patients with newly diagnosed AML and advanced SM.
Physicians who want to request midostaurin for eligible patients can contact a Novartis medical representative in their respective countries. In the US, physicians can call 1-888-NOW-NOVA (1-888-669-6682) for more information.
EMA recommends orphan status for drug in AML
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that BP1001 receive orphan designation as a treatment for acute myeloid leukemia (AML).
BP1001 (liposomal Grb2 antisense) is a neutral-charge, liposome-incorporated, antisense drug designed to inhibit protein synthesis of growth factor receptor bound protein 2 (Grb2).
BP1001 is being developed by Bio-Path Holdings, Inc.
According to Bio-Path, inhibition of Grb2 by BP1001 represents a significant advance in treating cancers with activated tyrosine kinases using a target not druggable with small molecule inhibitors.
Research has suggested that Grb2 plays an essential role in cancer cell activation via the RAS pathway. Grb2 bridges signals between activated and mutated tyrosine kinases, such as Flt3, c-Kit, and Bcr-Abl, and the Ras pathway, leading to activation of the ERK and AKT proteins.
About orphan designation
The EMA’s COMP adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.
Trials of BP1001
Bio-Path has completed a phase 1 trial of BP1001 in patients with relapsed/refractory AML, chronic myeloid leukemia, and myelodysplastic syndromes.
The company has also completed the safety segment of a phase 2 trial in which BP1001 is being investigated in combination with low-dose ara-C to treat AML.
Bio-Path recently released data from these studies.
The phase 1 study included patients who had received an average of 6 prior therapies.
The patients received 8 doses of BP1001 over 4 weeks, escalating to a maximum dose of 90 mg/m2. There were no dose-limiting toxicities, and Bio-Path said the drug was well tolerated.
Of the 18 evaluable patients with circulating blasts, 83% responded to BP1001. The average reduction in circulating blasts was 67%.
The phase 2 trial included patients with relapsed/refractory AML. There were 3 evaluable patients in each of 2 dosing cohorts—60 mg/m2 and 90 mg/m2. Patients received BP1001 twice a week for 4 weeks.
Five of the patients responded—3 with a complete response and 2 with a partial response. There were no adverse events attributed to BP1001, and the maximum-tolerated dose was not reached.
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that BP1001 receive orphan designation as a treatment for acute myeloid leukemia (AML).
BP1001 (liposomal Grb2 antisense) is a neutral-charge, liposome-incorporated, antisense drug designed to inhibit protein synthesis of growth factor receptor bound protein 2 (Grb2).
BP1001 is being developed by Bio-Path Holdings, Inc.
According to Bio-Path, inhibition of Grb2 by BP1001 represents a significant advance in treating cancers with activated tyrosine kinases using a target not druggable with small molecule inhibitors.
Research has suggested that Grb2 plays an essential role in cancer cell activation via the RAS pathway. Grb2 bridges signals between activated and mutated tyrosine kinases, such as Flt3, c-Kit, and Bcr-Abl, and the Ras pathway, leading to activation of the ERK and AKT proteins.
About orphan designation
The EMA’s COMP adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.
Trials of BP1001
Bio-Path has completed a phase 1 trial of BP1001 in patients with relapsed/refractory AML, chronic myeloid leukemia, and myelodysplastic syndromes.
The company has also completed the safety segment of a phase 2 trial in which BP1001 is being investigated in combination with low-dose ara-C to treat AML.
Bio-Path recently released data from these studies.
The phase 1 study included patients who had received an average of 6 prior therapies.
The patients received 8 doses of BP1001 over 4 weeks, escalating to a maximum dose of 90 mg/m2. There were no dose-limiting toxicities, and Bio-Path said the drug was well tolerated.
Of the 18 evaluable patients with circulating blasts, 83% responded to BP1001. The average reduction in circulating blasts was 67%.
The phase 2 trial included patients with relapsed/refractory AML. There were 3 evaluable patients in each of 2 dosing cohorts—60 mg/m2 and 90 mg/m2. Patients received BP1001 twice a week for 4 weeks.
Five of the patients responded—3 with a complete response and 2 with a partial response. There were no adverse events attributed to BP1001, and the maximum-tolerated dose was not reached.
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that BP1001 receive orphan designation as a treatment for acute myeloid leukemia (AML).
BP1001 (liposomal Grb2 antisense) is a neutral-charge, liposome-incorporated, antisense drug designed to inhibit protein synthesis of growth factor receptor bound protein 2 (Grb2).
BP1001 is being developed by Bio-Path Holdings, Inc.
According to Bio-Path, inhibition of Grb2 by BP1001 represents a significant advance in treating cancers with activated tyrosine kinases using a target not druggable with small molecule inhibitors.
Research has suggested that Grb2 plays an essential role in cancer cell activation via the RAS pathway. Grb2 bridges signals between activated and mutated tyrosine kinases, such as Flt3, c-Kit, and Bcr-Abl, and the Ras pathway, leading to activation of the ERK and AKT proteins.
About orphan designation
The EMA’s COMP adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.
Trials of BP1001
Bio-Path has completed a phase 1 trial of BP1001 in patients with relapsed/refractory AML, chronic myeloid leukemia, and myelodysplastic syndromes.
The company has also completed the safety segment of a phase 2 trial in which BP1001 is being investigated in combination with low-dose ara-C to treat AML.
Bio-Path recently released data from these studies.
The phase 1 study included patients who had received an average of 6 prior therapies.
The patients received 8 doses of BP1001 over 4 weeks, escalating to a maximum dose of 90 mg/m2. There were no dose-limiting toxicities, and Bio-Path said the drug was well tolerated.
Of the 18 evaluable patients with circulating blasts, 83% responded to BP1001. The average reduction in circulating blasts was 67%.
The phase 2 trial included patients with relapsed/refractory AML. There were 3 evaluable patients in each of 2 dosing cohorts—60 mg/m2 and 90 mg/m2. Patients received BP1001 twice a week for 4 weeks.
Five of the patients responded—3 with a complete response and 2 with a partial response. There were no adverse events attributed to BP1001, and the maximum-tolerated dose was not reached.
Patients Know About Diabetic Retinopathy Risk—But Don’t Get Screened
Patients may understand that diabetes can lead to eye disease, and they may receive a recommendation for screening for diabetic retinopathy—but that doesn’t mean they’ll get screened. Researchers from Harbor-UCLA Medical Center surveyed 101 patients with diabetes and 44 providers and staffers at a clinic where annual screening rates for diabetic retinopathy were low. They found that 93% of patients understood the potential risk, but only 55% were getting screened.
The study goal, however, wasn’t to measure understanding of risk but to find out what patients considered barriers to screening and whether health care providers (HCPs) understood those barriers. And the researchers found a gap between the 2 groups.
Related: Long-Acting Insulin Analogs: Effects on Diabetic Retinopathy
Patients were mostly low-income Hispanics and African Americans. The survey asked participants to rate any given barrier that would delay or prevent getting screened. Health care providers and staff were asked to rate the importance of addressing the barriers.
Most of the patients (26%) reported at least 1 barrier to screening, most commonly depression (22%) and financial problems (26%); others reported language issues, lack of transportation, and lack of time.
When surveying HCPs, though, the researchers found “markedly divergent perceptions” between the 2 groups. For instance, only small numbers of patients said transportation, language issues, denial, fear, or cultural beliefs were barriers—yet most HCPs and staff thought those were “very” or “extremely important.”
Related: Diabetic Macular Edema: Is Your Patient Going Blind?
By contrast, the barriers the patients did think were important—financial burdens and depression—were rated as less important than other barriers by the HCPs and staff.
The differences in opinions suggest “a lack of high-quality patient-provider communication,” the researchers say. They suggest that more effective patient education as well as heightened awareness of depression and its impact are key to getting more patients screened.
Patients may understand that diabetes can lead to eye disease, and they may receive a recommendation for screening for diabetic retinopathy—but that doesn’t mean they’ll get screened. Researchers from Harbor-UCLA Medical Center surveyed 101 patients with diabetes and 44 providers and staffers at a clinic where annual screening rates for diabetic retinopathy were low. They found that 93% of patients understood the potential risk, but only 55% were getting screened.
The study goal, however, wasn’t to measure understanding of risk but to find out what patients considered barriers to screening and whether health care providers (HCPs) understood those barriers. And the researchers found a gap between the 2 groups.
Related: Long-Acting Insulin Analogs: Effects on Diabetic Retinopathy
Patients were mostly low-income Hispanics and African Americans. The survey asked participants to rate any given barrier that would delay or prevent getting screened. Health care providers and staff were asked to rate the importance of addressing the barriers.
Most of the patients (26%) reported at least 1 barrier to screening, most commonly depression (22%) and financial problems (26%); others reported language issues, lack of transportation, and lack of time.
When surveying HCPs, though, the researchers found “markedly divergent perceptions” between the 2 groups. For instance, only small numbers of patients said transportation, language issues, denial, fear, or cultural beliefs were barriers—yet most HCPs and staff thought those were “very” or “extremely important.”
Related: Diabetic Macular Edema: Is Your Patient Going Blind?
By contrast, the barriers the patients did think were important—financial burdens and depression—were rated as less important than other barriers by the HCPs and staff.
The differences in opinions suggest “a lack of high-quality patient-provider communication,” the researchers say. They suggest that more effective patient education as well as heightened awareness of depression and its impact are key to getting more patients screened.
Patients may understand that diabetes can lead to eye disease, and they may receive a recommendation for screening for diabetic retinopathy—but that doesn’t mean they’ll get screened. Researchers from Harbor-UCLA Medical Center surveyed 101 patients with diabetes and 44 providers and staffers at a clinic where annual screening rates for diabetic retinopathy were low. They found that 93% of patients understood the potential risk, but only 55% were getting screened.
The study goal, however, wasn’t to measure understanding of risk but to find out what patients considered barriers to screening and whether health care providers (HCPs) understood those barriers. And the researchers found a gap between the 2 groups.
Related: Long-Acting Insulin Analogs: Effects on Diabetic Retinopathy
Patients were mostly low-income Hispanics and African Americans. The survey asked participants to rate any given barrier that would delay or prevent getting screened. Health care providers and staff were asked to rate the importance of addressing the barriers.
Most of the patients (26%) reported at least 1 barrier to screening, most commonly depression (22%) and financial problems (26%); others reported language issues, lack of transportation, and lack of time.
When surveying HCPs, though, the researchers found “markedly divergent perceptions” between the 2 groups. For instance, only small numbers of patients said transportation, language issues, denial, fear, or cultural beliefs were barriers—yet most HCPs and staff thought those were “very” or “extremely important.”
Related: Diabetic Macular Edema: Is Your Patient Going Blind?
By contrast, the barriers the patients did think were important—financial burdens and depression—were rated as less important than other barriers by the HCPs and staff.
The differences in opinions suggest “a lack of high-quality patient-provider communication,” the researchers say. They suggest that more effective patient education as well as heightened awareness of depression and its impact are key to getting more patients screened.
Preschool ADHD diagnoses plateaued after 2011 AAP guideline
The introduction of the 2011 American Academy of Pediatrics practice guidelines on attention-deficit/hyperactivity disorder was associated with a leveling off in the number of diagnoses in preschool children.
“In the preguideline period, the trajectory of ADHD diagnosis increased slightly but significantly across practices,” Alexander G. Fiks, MD, from the Children’s Hospital of Philadelphia, and his coinvestigators wrote. “However, the rate of ADHD diagnosis no longer increased significantly after guideline release.”
They found that the rate of ADHD diagnoses was 0.7% before the release of the 2011 guidelines and 0.9% after, while the rate of stimulant prescriptions remained constant at 0.4% across the entire study period (Pediatrics. 2016 Nov 15. doi: 10.1542/peds.2016-2025).
While the levels of stimulants prescribed remained the same across the period of the analysis, the proportion of children diagnosed with ADHD who were prescribed stimulants had already been in significant decline before the release of the guidelines. After the guidelines, this rate also plateaued, signifying that before – but not after – the guidelines, children were becoming less likely to be prescribed stimulant medication following an ADHD diagnosis.
Commenting on the change in diagnostic and prescribing patterns, the investigators noted that the primary goal of practice guidelines was to standardize care.
“In the case of preschool ADHD, such standardization might have resulted in an increasing trajectory in diagnosis of preschool children if pediatric clinicians had not previously been evaluating ADHD when an evaluation was warranted,” they wrote. “Alternatively, a decrease in diagnosis could have occurred if clinicians were applying more rigorous standards to the diagnosis and therefore excluding certain children who might have previously been diagnosed or no change if a combination of these two patterns was occurring or if there was no change in the standard used.”
They suggested that the observation of a decreasing likelihood of stimulant prescriptions for ADHD before the guidelines may have been driven by the results of the 2006 Preschool ADHD Treatment Study, which showed a lower effect size of stimulant medication in preschool-aged children, compared with school-aged children.
“Alternatively, findings may have resulted from a decrease in the severity of preschool children diagnosed with ADHD as the proportion of all preschoolers diagnosed with ADHD increased,” they wrote.
The study was supported by the U.S. Department of Health & Human Services. Dr. Fiks reported receiving a research grant from Pfizer for work on ADHD unrelated to this study. The other investigators reported having no financial disclosures.
It is encouraging for those of us who worked on crafting the revised guidelines to find some evidence about the impact of those recommendations. However, as the investigators point out, although they were able to find out that, in preschool-aged children with ADHD, recommended criteria for the use of stimulant medications, specifically methylphenidate, did not result in an increase in its use in this age group, the frequency of behavioral parent training, the first-line recommended treatment, could not be determined.
In addition, to address the issue that was the focus of this study, examining the implementation of evidence into practice, there needs to be greater standardization of assessment and treatment modalities so that we can better examine the outcomes of changes in treatment. Studies of prevalence and treatments of children with ADHD have indicated wide variations across the country. Clarifying those differences will require the improved ability to examine the various factors responsible for these variations, particularly across the systems of care that go beyond just medication use.
Mark L. Wolraich, MD, is from the University of Oklahoma Health Sciences Center, Oklahoma City. These comments are adapted from an accompanying editorial (Pediatrics. 2016 Nov 15. doi: 10.1542/peds.2016-2928). He reported having no financial disclosures.
It is encouraging for those of us who worked on crafting the revised guidelines to find some evidence about the impact of those recommendations. However, as the investigators point out, although they were able to find out that, in preschool-aged children with ADHD, recommended criteria for the use of stimulant medications, specifically methylphenidate, did not result in an increase in its use in this age group, the frequency of behavioral parent training, the first-line recommended treatment, could not be determined.
In addition, to address the issue that was the focus of this study, examining the implementation of evidence into practice, there needs to be greater standardization of assessment and treatment modalities so that we can better examine the outcomes of changes in treatment. Studies of prevalence and treatments of children with ADHD have indicated wide variations across the country. Clarifying those differences will require the improved ability to examine the various factors responsible for these variations, particularly across the systems of care that go beyond just medication use.
Mark L. Wolraich, MD, is from the University of Oklahoma Health Sciences Center, Oklahoma City. These comments are adapted from an accompanying editorial (Pediatrics. 2016 Nov 15. doi: 10.1542/peds.2016-2928). He reported having no financial disclosures.
It is encouraging for those of us who worked on crafting the revised guidelines to find some evidence about the impact of those recommendations. However, as the investigators point out, although they were able to find out that, in preschool-aged children with ADHD, recommended criteria for the use of stimulant medications, specifically methylphenidate, did not result in an increase in its use in this age group, the frequency of behavioral parent training, the first-line recommended treatment, could not be determined.
In addition, to address the issue that was the focus of this study, examining the implementation of evidence into practice, there needs to be greater standardization of assessment and treatment modalities so that we can better examine the outcomes of changes in treatment. Studies of prevalence and treatments of children with ADHD have indicated wide variations across the country. Clarifying those differences will require the improved ability to examine the various factors responsible for these variations, particularly across the systems of care that go beyond just medication use.
Mark L. Wolraich, MD, is from the University of Oklahoma Health Sciences Center, Oklahoma City. These comments are adapted from an accompanying editorial (Pediatrics. 2016 Nov 15. doi: 10.1542/peds.2016-2928). He reported having no financial disclosures.
The introduction of the 2011 American Academy of Pediatrics practice guidelines on attention-deficit/hyperactivity disorder was associated with a leveling off in the number of diagnoses in preschool children.
“In the preguideline period, the trajectory of ADHD diagnosis increased slightly but significantly across practices,” Alexander G. Fiks, MD, from the Children’s Hospital of Philadelphia, and his coinvestigators wrote. “However, the rate of ADHD diagnosis no longer increased significantly after guideline release.”
They found that the rate of ADHD diagnoses was 0.7% before the release of the 2011 guidelines and 0.9% after, while the rate of stimulant prescriptions remained constant at 0.4% across the entire study period (Pediatrics. 2016 Nov 15. doi: 10.1542/peds.2016-2025).
While the levels of stimulants prescribed remained the same across the period of the analysis, the proportion of children diagnosed with ADHD who were prescribed stimulants had already been in significant decline before the release of the guidelines. After the guidelines, this rate also plateaued, signifying that before – but not after – the guidelines, children were becoming less likely to be prescribed stimulant medication following an ADHD diagnosis.
Commenting on the change in diagnostic and prescribing patterns, the investigators noted that the primary goal of practice guidelines was to standardize care.
“In the case of preschool ADHD, such standardization might have resulted in an increasing trajectory in diagnosis of preschool children if pediatric clinicians had not previously been evaluating ADHD when an evaluation was warranted,” they wrote. “Alternatively, a decrease in diagnosis could have occurred if clinicians were applying more rigorous standards to the diagnosis and therefore excluding certain children who might have previously been diagnosed or no change if a combination of these two patterns was occurring or if there was no change in the standard used.”
They suggested that the observation of a decreasing likelihood of stimulant prescriptions for ADHD before the guidelines may have been driven by the results of the 2006 Preschool ADHD Treatment Study, which showed a lower effect size of stimulant medication in preschool-aged children, compared with school-aged children.
“Alternatively, findings may have resulted from a decrease in the severity of preschool children diagnosed with ADHD as the proportion of all preschoolers diagnosed with ADHD increased,” they wrote.
The study was supported by the U.S. Department of Health & Human Services. Dr. Fiks reported receiving a research grant from Pfizer for work on ADHD unrelated to this study. The other investigators reported having no financial disclosures.
The introduction of the 2011 American Academy of Pediatrics practice guidelines on attention-deficit/hyperactivity disorder was associated with a leveling off in the number of diagnoses in preschool children.
“In the preguideline period, the trajectory of ADHD diagnosis increased slightly but significantly across practices,” Alexander G. Fiks, MD, from the Children’s Hospital of Philadelphia, and his coinvestigators wrote. “However, the rate of ADHD diagnosis no longer increased significantly after guideline release.”
They found that the rate of ADHD diagnoses was 0.7% before the release of the 2011 guidelines and 0.9% after, while the rate of stimulant prescriptions remained constant at 0.4% across the entire study period (Pediatrics. 2016 Nov 15. doi: 10.1542/peds.2016-2025).
While the levels of stimulants prescribed remained the same across the period of the analysis, the proportion of children diagnosed with ADHD who were prescribed stimulants had already been in significant decline before the release of the guidelines. After the guidelines, this rate also plateaued, signifying that before – but not after – the guidelines, children were becoming less likely to be prescribed stimulant medication following an ADHD diagnosis.
Commenting on the change in diagnostic and prescribing patterns, the investigators noted that the primary goal of practice guidelines was to standardize care.
“In the case of preschool ADHD, such standardization might have resulted in an increasing trajectory in diagnosis of preschool children if pediatric clinicians had not previously been evaluating ADHD when an evaluation was warranted,” they wrote. “Alternatively, a decrease in diagnosis could have occurred if clinicians were applying more rigorous standards to the diagnosis and therefore excluding certain children who might have previously been diagnosed or no change if a combination of these two patterns was occurring or if there was no change in the standard used.”
They suggested that the observation of a decreasing likelihood of stimulant prescriptions for ADHD before the guidelines may have been driven by the results of the 2006 Preschool ADHD Treatment Study, which showed a lower effect size of stimulant medication in preschool-aged children, compared with school-aged children.
“Alternatively, findings may have resulted from a decrease in the severity of preschool children diagnosed with ADHD as the proportion of all preschoolers diagnosed with ADHD increased,” they wrote.
The study was supported by the U.S. Department of Health & Human Services. Dr. Fiks reported receiving a research grant from Pfizer for work on ADHD unrelated to this study. The other investigators reported having no financial disclosures.
Key clinical point:
Major finding: The rate of ADHD diagnoses was 0.7% before the guidelines and 0.9% after, while stimulant prescriptions remained constant at 0.4% across the study period.
Data source: An analysis of electronic health record data from 143,881 children across 63 primary care practice from January 2008 to July 2014.
Disclosures: The study was supported by the U.S. Department of Health & Human Services. Dr. Fiks reported receiving a research grant from Pfizer for work on ADHD unrelated to this study. The other investigators reported having no financial disclosures.