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Study: Test carcinoembryonic antigen in colon cancer after surgery
A new study challenges the practice of measuring carcinoembryonic antigen (CEA) in patients with colon cancer prior to surgery, as is currently recommended by some guidelines. Researchers found that the levels do have predictive value about risk of recurrence when tested after surgery, but they challenge its use before.
“Consistent with the literature, our data show that postoperative CEA is more informative than preoperative CEA,” the study authors wrote. “Emphasis should be placed on postoperative CEA, and in the setting of modern high-quality imaging, we question the utility of measuring preoperative CEA.”
The study, which was published online in JAMA Oncology, noted that testing for CEA – a colorectal cancer tumor marker – had more value prior to the current era of imaging because it could indicate the need to widen a search for metastases.
“In the era of high-quality computed tomography (CT), the utility of measuring preoperative CEA is less obvious because an elevated preoperative CEA with a normal CT scan does not preclude surgery with curative intent,” wrote Tsuyoshi Konishi, MD, of Memorial Sloan-Kettering Cancer Center in New York and his coauthors.
CEA levels can return to normal after colon cancer surgery – but not always. According to the study, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the European Group on Tumor Markers recommend its measurement prior to surgery in patients with nonmetastatic cancer.
For the new study, the authors sought to understand the predictive value of various CEA levels both before and after surgery.
The researchers retrospectively tracked 1,027 patients at a single center with stage I-III colon cancer (50.4% male; median age, 64 years). (Another 221 patients had been removed because of exclusion criteria, such as recent malignancy treatment and preoperative chemotherapy or radiation treatment.)
Nearly 70% of the 1,027 patients had normal preoperative CEA levels, and the rest had elevated levels.
Of the 312 patients with elevated preoperative CEA levels, 113 were lost to follow-up postoperative CEA tests. In the remaining patients, CEA levels returned to normal in 71%.
Patients were followed for a median of 38 months; 10.3% had recurrences, and 4.6% died. The 3-year recurrence-free survival rate was 88.4%.
Researchers found that those with normal preoperative CEA levels were more likely to reach recurrence-free survival at 3 years (89.7%) than were those who had elevated preoperative CEA levels (82.3%; P = .05). The higher level wasn’t much different than the recurrence-free survival level in those whose CEA levels had normalized after the operation (87.9%; P = .86).
Those with elevated CEA levels after surgery had a lower likelihood of reaching recurrence-free survival at 3 years (74.5%) than did those who had normal postoperative CEA levels (89.4%).
The study also linked abnormal postoperative CEA levels to shorter recurrence-free survival (hazard ratio, 2.0; 95% confidence interval, 1.1-3.5). Normalized postoperative CEA levels, however, were not linked to shorter recurrence-free survival (HR, 0.77; 95% CI, 0.45-1.30).
The researchers noted that they didn’t control for factors such as smoking (which increases CEA levels) and disease like gastritis and diabetes, which can produce misleading CEA levels. “Rather, this study is pragmatic,” the researchers wrote, “and represents what is likely to be seen in real-world colorectal cancer care.”
Moving forward, the researchers wrote, “patients with elevated postoperative CEA tend to experience recurrence early, which might justify a risk-adjusted and individualized surveillance strategy.”
The study authors report no relevant disclosures. The National Institutes of Health/National Cancer Institute funded the study in part.
SOURCE: Konishi T et al. JAMA Oncol. 2017. doi: 10.1001/jamaoncol.2017.4420.
Multiple organizations recommend that patients with nonmetastatic colorectal cancer undergo carcinoembryonic antigen (CEA) measurement prior to surgery, and there’s talk that it should be added to the staging system of the American Joint Committee on Cancer.
This new study, however, provides a challenge to the use of preoperative CEA tests in this population. As the researchers report, patients with normalized CEA levels postsurgery – even those with abnormal levels before surgery – were more likely to reach recurrence-free survival for 3 years.
The findings spotlight the value of real-world evidence and real-world data rather than statistics gathered during a controlled clinical trial.
There are limitations to this study, such as generalizability (it was performed at a single center), loss of patients to CEA follow-up postsurgery, and timing (the study period began a decade ago).
Still, the findings, once confirmed, could change clinical practice, and they point to the potential use of CEA as a biomarker early-warning sign that a tumor may recur.
Rebecca Anne Miksad, MD, MPH, is with Harvard Medical School in Boston (leave of absence from 2017 to 2018) and Neal J. Meropol, MD, is with Case Western Reserve University in Cleveland. They disclose employment by Flatiron Health. These comments are taken from their editorial accompanying the study by Konishi et al. in JAMA Oncology, doi:10.1001/jamaoncol.2017.4420.
Multiple organizations recommend that patients with nonmetastatic colorectal cancer undergo carcinoembryonic antigen (CEA) measurement prior to surgery, and there’s talk that it should be added to the staging system of the American Joint Committee on Cancer.
This new study, however, provides a challenge to the use of preoperative CEA tests in this population. As the researchers report, patients with normalized CEA levels postsurgery – even those with abnormal levels before surgery – were more likely to reach recurrence-free survival for 3 years.
The findings spotlight the value of real-world evidence and real-world data rather than statistics gathered during a controlled clinical trial.
There are limitations to this study, such as generalizability (it was performed at a single center), loss of patients to CEA follow-up postsurgery, and timing (the study period began a decade ago).
Still, the findings, once confirmed, could change clinical practice, and they point to the potential use of CEA as a biomarker early-warning sign that a tumor may recur.
Rebecca Anne Miksad, MD, MPH, is with Harvard Medical School in Boston (leave of absence from 2017 to 2018) and Neal J. Meropol, MD, is with Case Western Reserve University in Cleveland. They disclose employment by Flatiron Health. These comments are taken from their editorial accompanying the study by Konishi et al. in JAMA Oncology, doi:10.1001/jamaoncol.2017.4420.
Multiple organizations recommend that patients with nonmetastatic colorectal cancer undergo carcinoembryonic antigen (CEA) measurement prior to surgery, and there’s talk that it should be added to the staging system of the American Joint Committee on Cancer.
This new study, however, provides a challenge to the use of preoperative CEA tests in this population. As the researchers report, patients with normalized CEA levels postsurgery – even those with abnormal levels before surgery – were more likely to reach recurrence-free survival for 3 years.
The findings spotlight the value of real-world evidence and real-world data rather than statistics gathered during a controlled clinical trial.
There are limitations to this study, such as generalizability (it was performed at a single center), loss of patients to CEA follow-up postsurgery, and timing (the study period began a decade ago).
Still, the findings, once confirmed, could change clinical practice, and they point to the potential use of CEA as a biomarker early-warning sign that a tumor may recur.
Rebecca Anne Miksad, MD, MPH, is with Harvard Medical School in Boston (leave of absence from 2017 to 2018) and Neal J. Meropol, MD, is with Case Western Reserve University in Cleveland. They disclose employment by Flatiron Health. These comments are taken from their editorial accompanying the study by Konishi et al. in JAMA Oncology, doi:10.1001/jamaoncol.2017.4420.
A new study challenges the practice of measuring carcinoembryonic antigen (CEA) in patients with colon cancer prior to surgery, as is currently recommended by some guidelines. Researchers found that the levels do have predictive value about risk of recurrence when tested after surgery, but they challenge its use before.
“Consistent with the literature, our data show that postoperative CEA is more informative than preoperative CEA,” the study authors wrote. “Emphasis should be placed on postoperative CEA, and in the setting of modern high-quality imaging, we question the utility of measuring preoperative CEA.”
The study, which was published online in JAMA Oncology, noted that testing for CEA – a colorectal cancer tumor marker – had more value prior to the current era of imaging because it could indicate the need to widen a search for metastases.
“In the era of high-quality computed tomography (CT), the utility of measuring preoperative CEA is less obvious because an elevated preoperative CEA with a normal CT scan does not preclude surgery with curative intent,” wrote Tsuyoshi Konishi, MD, of Memorial Sloan-Kettering Cancer Center in New York and his coauthors.
CEA levels can return to normal after colon cancer surgery – but not always. According to the study, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the European Group on Tumor Markers recommend its measurement prior to surgery in patients with nonmetastatic cancer.
For the new study, the authors sought to understand the predictive value of various CEA levels both before and after surgery.
The researchers retrospectively tracked 1,027 patients at a single center with stage I-III colon cancer (50.4% male; median age, 64 years). (Another 221 patients had been removed because of exclusion criteria, such as recent malignancy treatment and preoperative chemotherapy or radiation treatment.)
Nearly 70% of the 1,027 patients had normal preoperative CEA levels, and the rest had elevated levels.
Of the 312 patients with elevated preoperative CEA levels, 113 were lost to follow-up postoperative CEA tests. In the remaining patients, CEA levels returned to normal in 71%.
Patients were followed for a median of 38 months; 10.3% had recurrences, and 4.6% died. The 3-year recurrence-free survival rate was 88.4%.
Researchers found that those with normal preoperative CEA levels were more likely to reach recurrence-free survival at 3 years (89.7%) than were those who had elevated preoperative CEA levels (82.3%; P = .05). The higher level wasn’t much different than the recurrence-free survival level in those whose CEA levels had normalized after the operation (87.9%; P = .86).
Those with elevated CEA levels after surgery had a lower likelihood of reaching recurrence-free survival at 3 years (74.5%) than did those who had normal postoperative CEA levels (89.4%).
The study also linked abnormal postoperative CEA levels to shorter recurrence-free survival (hazard ratio, 2.0; 95% confidence interval, 1.1-3.5). Normalized postoperative CEA levels, however, were not linked to shorter recurrence-free survival (HR, 0.77; 95% CI, 0.45-1.30).
The researchers noted that they didn’t control for factors such as smoking (which increases CEA levels) and disease like gastritis and diabetes, which can produce misleading CEA levels. “Rather, this study is pragmatic,” the researchers wrote, “and represents what is likely to be seen in real-world colorectal cancer care.”
Moving forward, the researchers wrote, “patients with elevated postoperative CEA tend to experience recurrence early, which might justify a risk-adjusted and individualized surveillance strategy.”
The study authors report no relevant disclosures. The National Institutes of Health/National Cancer Institute funded the study in part.
SOURCE: Konishi T et al. JAMA Oncol. 2017. doi: 10.1001/jamaoncol.2017.4420.
A new study challenges the practice of measuring carcinoembryonic antigen (CEA) in patients with colon cancer prior to surgery, as is currently recommended by some guidelines. Researchers found that the levels do have predictive value about risk of recurrence when tested after surgery, but they challenge its use before.
“Consistent with the literature, our data show that postoperative CEA is more informative than preoperative CEA,” the study authors wrote. “Emphasis should be placed on postoperative CEA, and in the setting of modern high-quality imaging, we question the utility of measuring preoperative CEA.”
The study, which was published online in JAMA Oncology, noted that testing for CEA – a colorectal cancer tumor marker – had more value prior to the current era of imaging because it could indicate the need to widen a search for metastases.
“In the era of high-quality computed tomography (CT), the utility of measuring preoperative CEA is less obvious because an elevated preoperative CEA with a normal CT scan does not preclude surgery with curative intent,” wrote Tsuyoshi Konishi, MD, of Memorial Sloan-Kettering Cancer Center in New York and his coauthors.
CEA levels can return to normal after colon cancer surgery – but not always. According to the study, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the European Group on Tumor Markers recommend its measurement prior to surgery in patients with nonmetastatic cancer.
For the new study, the authors sought to understand the predictive value of various CEA levels both before and after surgery.
The researchers retrospectively tracked 1,027 patients at a single center with stage I-III colon cancer (50.4% male; median age, 64 years). (Another 221 patients had been removed because of exclusion criteria, such as recent malignancy treatment and preoperative chemotherapy or radiation treatment.)
Nearly 70% of the 1,027 patients had normal preoperative CEA levels, and the rest had elevated levels.
Of the 312 patients with elevated preoperative CEA levels, 113 were lost to follow-up postoperative CEA tests. In the remaining patients, CEA levels returned to normal in 71%.
Patients were followed for a median of 38 months; 10.3% had recurrences, and 4.6% died. The 3-year recurrence-free survival rate was 88.4%.
Researchers found that those with normal preoperative CEA levels were more likely to reach recurrence-free survival at 3 years (89.7%) than were those who had elevated preoperative CEA levels (82.3%; P = .05). The higher level wasn’t much different than the recurrence-free survival level in those whose CEA levels had normalized after the operation (87.9%; P = .86).
Those with elevated CEA levels after surgery had a lower likelihood of reaching recurrence-free survival at 3 years (74.5%) than did those who had normal postoperative CEA levels (89.4%).
The study also linked abnormal postoperative CEA levels to shorter recurrence-free survival (hazard ratio, 2.0; 95% confidence interval, 1.1-3.5). Normalized postoperative CEA levels, however, were not linked to shorter recurrence-free survival (HR, 0.77; 95% CI, 0.45-1.30).
The researchers noted that they didn’t control for factors such as smoking (which increases CEA levels) and disease like gastritis and diabetes, which can produce misleading CEA levels. “Rather, this study is pragmatic,” the researchers wrote, “and represents what is likely to be seen in real-world colorectal cancer care.”
Moving forward, the researchers wrote, “patients with elevated postoperative CEA tend to experience recurrence early, which might justify a risk-adjusted and individualized surveillance strategy.”
The study authors report no relevant disclosures. The National Institutes of Health/National Cancer Institute funded the study in part.
SOURCE: Konishi T et al. JAMA Oncol. 2017. doi: 10.1001/jamaoncol.2017.4420.
FROM JAMA ONCOLOGY
Key clinical point: Measurement of CEA levels in patients with colon cancer appears to have value postoperatively but not preoperatively.
Major finding: Patients with abnormal postoperative CEA levels were less likely to reach 3-year recurrence-free survival than were those with normal levels (74.5% vs. 89.4%).
Study details: Retrospective, single-center study of 1,027 patients with stage I-III colon cancer (50.4% male; median age, 64 years).
Disclosures: The study authors report no relevant disclosures. The National Institutes of Health/National Cancer Institute funded the study in part.
Source: Konishi T et al. JAMA Oncol. 2017. doi: 10.1001/jamaoncol.2017.4420.
Online education program linked to less anxiety, medication use in colonoscopies
An online education program appeared to dampen anxiety levels in colonoscopy patients and even seemed to reduce the burden of the procedure in terms of time and medication used, a study showed.
“The program was very well received and generally improved patient’s anxiety,” said lead author Siddhartha Parker, MD, a gastroenterologist at Dartmouth-Hitchcock Medical Center, Lebanon, N.H. “Only 4% of patients described feeling more anxious after watching the program whereas 58% felt less anxious.”
“Patients who are afraid or anxious may require more sedation, experience more pain, and, most importantly, may be less likely to have a procedure done,” he said. “Some patients don’t schedule at all, while others may schedule and then cancel last minute or no-show an appointment, which has its own implications and costs to the health care system.”
In terms of anxiety prevention, he said, “primarily we rely on nurses and doctors to discuss the need for screening and provide reassurance about low risks and real benefits.”
For the current study, published in the Journal of Clinical Gastroenterology, researchers tested a Web-based colonoscopy education program from a company called Emmi Solutions.
The program is designed to provide details about the colonoscopy process. “It covers what to expect before, during, and after the procedure including possible findings (e.g., polyps),” Dr. Parker said. “It also covers risks and benefits with some tips on recovery after the procedure. I think having some dedicated time to understand the procedure is most helpful. It is rare that a patient gets 15-20 minutes to review any topic with their doctor, and the Emmi program has the added benefit of visual cues.”
The researchers recruited and randomly assigned 51 patients to a control group and 52 patients to the intervention. All were scheduled to undergo colonoscopies within at least 2 weeks.
The groups were similar: Most patients were white (100% of the control group, 89% of the intervention group), and most were female; the average age was 48 years The intervention group had more education, at 69% with college degrees vs. 43% in the control group (P = .01).
Patients in the control group received usual colonoscopy education materials, while those in the intervention group were also directed to the education website.
All participants took a survey immediately before their procedures and received a $10 gift card as reimbursement for their participation.
Researchers found that patients in the intervention group scored higher than did those in the control group on questions about colonoscopy knowledge (82% of questions correct vs. 74%, P less than .001).
Also, the education website may have convinced its viewers to worry less about the procedure and more about its ultimate findings. Compared with the control group, those in the intervention group were more likely to say they were most concerned about the findings (38.5% vs. 21.6%) and less likely to say they were more concerned about both the findings and the procedure (38.5% vs. 56.9%). Roughly 20% of those in both groups said they were most concerned about the procedure.
“Some patients report being more concerned about findings, e.g., cancer, before the program but more anxious about complications after the program,” Dr. Parker said. “I think that is a reasonable outcome as asymptomatic patients should have very little concern about findings, given the goal is to find and remove polyps.”
Researchers also tracked the use of sedatives during the procedure. Those in the intervention group required less midazolam (Versed) (average dose of 3.66 mg vs. 4.46 mg, P = .004). They also required less fentanyl (164 mcg vs. 186 mcg), but this finding was not statistically significant (P = .063).
“There was also a trend, not quite statistically significant, to improved prep quality,” Dr. Parker said. (In the intervention vs. the control group, 96% vs. 88% of subjects were rated as good or excellent in terms of prep quality, P = .27).
“This is important because a poor or inadequate prep leads to a need for a repeat procedure to ensure adequate screening,” he said. “If prep quality improves, that means fewer unnecessary repeated procedures.”
The researchers reported study limitations such as multiple endoscopists and sedation nurses and the variation in education levels of the participants.
The cost of the interactive program was not available.
According to Dr. Parker, Dartmouth-Hitchcock Medical Center now offers the education program to all colonoscopy patients, and a modified version is available for those undergoing upper endoscopies.
“Not all patients have adequate computer resources, and some patients simply choose not to watch,” he said. “But my impression is that those who watched the program are more relaxed during the informed consent process. However, we are not actively tracking outcomes such as procedure time or medication usage.”
No more studies of the program are planned at the institution, he said.
One of the study authors is an employee of Emmi Solutions, which provided the program for free for use in the study. The other authors reported no relevant disclosures. No study funding was reported.
SOURCE: Parker S et al. J Clin Gastroenterol. doi: 10.1097/MCG.0000000000000958
An online education program appeared to dampen anxiety levels in colonoscopy patients and even seemed to reduce the burden of the procedure in terms of time and medication used, a study showed.
“The program was very well received and generally improved patient’s anxiety,” said lead author Siddhartha Parker, MD, a gastroenterologist at Dartmouth-Hitchcock Medical Center, Lebanon, N.H. “Only 4% of patients described feeling more anxious after watching the program whereas 58% felt less anxious.”
“Patients who are afraid or anxious may require more sedation, experience more pain, and, most importantly, may be less likely to have a procedure done,” he said. “Some patients don’t schedule at all, while others may schedule and then cancel last minute or no-show an appointment, which has its own implications and costs to the health care system.”
In terms of anxiety prevention, he said, “primarily we rely on nurses and doctors to discuss the need for screening and provide reassurance about low risks and real benefits.”
For the current study, published in the Journal of Clinical Gastroenterology, researchers tested a Web-based colonoscopy education program from a company called Emmi Solutions.
The program is designed to provide details about the colonoscopy process. “It covers what to expect before, during, and after the procedure including possible findings (e.g., polyps),” Dr. Parker said. “It also covers risks and benefits with some tips on recovery after the procedure. I think having some dedicated time to understand the procedure is most helpful. It is rare that a patient gets 15-20 minutes to review any topic with their doctor, and the Emmi program has the added benefit of visual cues.”
The researchers recruited and randomly assigned 51 patients to a control group and 52 patients to the intervention. All were scheduled to undergo colonoscopies within at least 2 weeks.
The groups were similar: Most patients were white (100% of the control group, 89% of the intervention group), and most were female; the average age was 48 years The intervention group had more education, at 69% with college degrees vs. 43% in the control group (P = .01).
Patients in the control group received usual colonoscopy education materials, while those in the intervention group were also directed to the education website.
All participants took a survey immediately before their procedures and received a $10 gift card as reimbursement for their participation.
Researchers found that patients in the intervention group scored higher than did those in the control group on questions about colonoscopy knowledge (82% of questions correct vs. 74%, P less than .001).
Also, the education website may have convinced its viewers to worry less about the procedure and more about its ultimate findings. Compared with the control group, those in the intervention group were more likely to say they were most concerned about the findings (38.5% vs. 21.6%) and less likely to say they were more concerned about both the findings and the procedure (38.5% vs. 56.9%). Roughly 20% of those in both groups said they were most concerned about the procedure.
“Some patients report being more concerned about findings, e.g., cancer, before the program but more anxious about complications after the program,” Dr. Parker said. “I think that is a reasonable outcome as asymptomatic patients should have very little concern about findings, given the goal is to find and remove polyps.”
Researchers also tracked the use of sedatives during the procedure. Those in the intervention group required less midazolam (Versed) (average dose of 3.66 mg vs. 4.46 mg, P = .004). They also required less fentanyl (164 mcg vs. 186 mcg), but this finding was not statistically significant (P = .063).
“There was also a trend, not quite statistically significant, to improved prep quality,” Dr. Parker said. (In the intervention vs. the control group, 96% vs. 88% of subjects were rated as good or excellent in terms of prep quality, P = .27).
“This is important because a poor or inadequate prep leads to a need for a repeat procedure to ensure adequate screening,” he said. “If prep quality improves, that means fewer unnecessary repeated procedures.”
The researchers reported study limitations such as multiple endoscopists and sedation nurses and the variation in education levels of the participants.
The cost of the interactive program was not available.
According to Dr. Parker, Dartmouth-Hitchcock Medical Center now offers the education program to all colonoscopy patients, and a modified version is available for those undergoing upper endoscopies.
“Not all patients have adequate computer resources, and some patients simply choose not to watch,” he said. “But my impression is that those who watched the program are more relaxed during the informed consent process. However, we are not actively tracking outcomes such as procedure time or medication usage.”
No more studies of the program are planned at the institution, he said.
One of the study authors is an employee of Emmi Solutions, which provided the program for free for use in the study. The other authors reported no relevant disclosures. No study funding was reported.
SOURCE: Parker S et al. J Clin Gastroenterol. doi: 10.1097/MCG.0000000000000958
An online education program appeared to dampen anxiety levels in colonoscopy patients and even seemed to reduce the burden of the procedure in terms of time and medication used, a study showed.
“The program was very well received and generally improved patient’s anxiety,” said lead author Siddhartha Parker, MD, a gastroenterologist at Dartmouth-Hitchcock Medical Center, Lebanon, N.H. “Only 4% of patients described feeling more anxious after watching the program whereas 58% felt less anxious.”
“Patients who are afraid or anxious may require more sedation, experience more pain, and, most importantly, may be less likely to have a procedure done,” he said. “Some patients don’t schedule at all, while others may schedule and then cancel last minute or no-show an appointment, which has its own implications and costs to the health care system.”
In terms of anxiety prevention, he said, “primarily we rely on nurses and doctors to discuss the need for screening and provide reassurance about low risks and real benefits.”
For the current study, published in the Journal of Clinical Gastroenterology, researchers tested a Web-based colonoscopy education program from a company called Emmi Solutions.
The program is designed to provide details about the colonoscopy process. “It covers what to expect before, during, and after the procedure including possible findings (e.g., polyps),” Dr. Parker said. “It also covers risks and benefits with some tips on recovery after the procedure. I think having some dedicated time to understand the procedure is most helpful. It is rare that a patient gets 15-20 minutes to review any topic with their doctor, and the Emmi program has the added benefit of visual cues.”
The researchers recruited and randomly assigned 51 patients to a control group and 52 patients to the intervention. All were scheduled to undergo colonoscopies within at least 2 weeks.
The groups were similar: Most patients were white (100% of the control group, 89% of the intervention group), and most were female; the average age was 48 years The intervention group had more education, at 69% with college degrees vs. 43% in the control group (P = .01).
Patients in the control group received usual colonoscopy education materials, while those in the intervention group were also directed to the education website.
All participants took a survey immediately before their procedures and received a $10 gift card as reimbursement for their participation.
Researchers found that patients in the intervention group scored higher than did those in the control group on questions about colonoscopy knowledge (82% of questions correct vs. 74%, P less than .001).
Also, the education website may have convinced its viewers to worry less about the procedure and more about its ultimate findings. Compared with the control group, those in the intervention group were more likely to say they were most concerned about the findings (38.5% vs. 21.6%) and less likely to say they were more concerned about both the findings and the procedure (38.5% vs. 56.9%). Roughly 20% of those in both groups said they were most concerned about the procedure.
“Some patients report being more concerned about findings, e.g., cancer, before the program but more anxious about complications after the program,” Dr. Parker said. “I think that is a reasonable outcome as asymptomatic patients should have very little concern about findings, given the goal is to find and remove polyps.”
Researchers also tracked the use of sedatives during the procedure. Those in the intervention group required less midazolam (Versed) (average dose of 3.66 mg vs. 4.46 mg, P = .004). They also required less fentanyl (164 mcg vs. 186 mcg), but this finding was not statistically significant (P = .063).
“There was also a trend, not quite statistically significant, to improved prep quality,” Dr. Parker said. (In the intervention vs. the control group, 96% vs. 88% of subjects were rated as good or excellent in terms of prep quality, P = .27).
“This is important because a poor or inadequate prep leads to a need for a repeat procedure to ensure adequate screening,” he said. “If prep quality improves, that means fewer unnecessary repeated procedures.”
The researchers reported study limitations such as multiple endoscopists and sedation nurses and the variation in education levels of the participants.
The cost of the interactive program was not available.
According to Dr. Parker, Dartmouth-Hitchcock Medical Center now offers the education program to all colonoscopy patients, and a modified version is available for those undergoing upper endoscopies.
“Not all patients have adequate computer resources, and some patients simply choose not to watch,” he said. “But my impression is that those who watched the program are more relaxed during the informed consent process. However, we are not actively tracking outcomes such as procedure time or medication usage.”
No more studies of the program are planned at the institution, he said.
One of the study authors is an employee of Emmi Solutions, which provided the program for free for use in the study. The other authors reported no relevant disclosures. No study funding was reported.
SOURCE: Parker S et al. J Clin Gastroenterol. doi: 10.1097/MCG.0000000000000958
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Key clinical point:
Major finding: Among program users, 58% reported being less anxious and required less midazolam during their procedures (average dose of 3.66 mg vs. 4.46 mg, P = .004).
Study details: A randomized, prospective study of 51 patients (control group) and 52 patients assigned to visit a website for a multimedia education program prior to colonoscopy.
Disclosures: One study author is an employee of the company that provided the program for free. The other study authors reported no relevant disclosures. No study funding was reported.
Source: Parker S et al. J Clin Gastroenterology. doi: 10.1097/MCG.0000000000000958.
Contraceptive use appears low in teen girls on teratogenic medications
SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.
The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.
The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.
“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”
“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”
In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.
The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.
About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”
The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.
Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”
In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.
The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.
SOURCE: Hays K et al. ACR 2017 Abstract 1813.
SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.
The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.
The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.
“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”
“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”
In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.
The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.
About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”
The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.
Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”
In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.
The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.
SOURCE: Hays K et al. ACR 2017 Abstract 1813.
SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.
The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.
The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.
“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”
“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”
In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.
The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.
About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”
The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.
Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”
In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.
The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.
SOURCE: Hays K et al. ACR 2017 Abstract 1813.
REPORTING FROM ACR 2017
Key clinical point:
Major finding: A total of 7.6% of teen girls taking teratogenic medications became pregnant during a 3-year period.
Study details: An analysis of 4,853 females aged 15-19 on Medicaid who were taking teratogenic medications.
Disclosures: The study authors had no relevant financial disclosures. The study had no external funding. The Medical University of South Carolina provided funding for database access.
Source: Hays K et al. ACR 2017 Abstract 1813.
Path CR signals good outcomes in treated high-risk breast cancers
REPORTING FROM SABCS 2017
SAN ANTONIO – Pathological complete response (pCR) is an accurate predictor of both event-free and distant recurrence-free survival in patients treated for stage 2 or 3 breast cancers with high risk for recurrence, according to investigators in the adaptive I-SPY2 trial.
Among 746 patients with various types of breast cancer evaluated in an intention-to-treat analysis, 3-year event-free survival (EFS) for those who had a pCR after chemotherapy and definitive surgery was 94%, compared with 76% for those who did not have a pCR.
Similarly, 3-year distant recurrence-free survival (DRFS) was 95% for patients who had a pCR after first-line therapy, compared with 79% for patients who did not, reported Douglas Yee, MD, of the Masonic Cancer Center at the University of Minnesota in Minneapolis.
“We find that path CR is a strong predictor of event-free survival and distance recurrence-free survival in the setting of a multiagent platform trial,” he said at the San Antonio Breast Cancer Symposium.
He explained that pCR is predictive of survival across all tumor subsets – regardless of hormone receptor status, HER2 status, and 70-gene signature (MammaPrint) status – and that pCR as a clinical trial endpoint allows investigators to rapidly evaluate novel therapeutic combinations, with the potential for identifying more effective and ideally less toxic regimens.
I-SPY 2 is a phase 2, adaptively randomized neoadjuvant clinical trial with a shared control arm in which patients receive standard neoadjuvant chemotherapy, and up to four simultaneous investigational arms. The primary endpoint is pCR, defined as no residual invasive cancer in the breast or lymph nodes, assessed according to the Residual Cancer Burden method. The goal is to match therapies with the most responsive breast cancer subtypes.
In the current analysis, the investigators looked at data on 245 patients with hormone receptor-negative and HER2– tumors (HR–/HER2–), 275 with HR-positive/HER2-negative tumors, 77 with HR–/HER2+ tumors, and 149 with tumors positive for both HR and HER2. Respective rates of pCR in these groups were 41%, 18%, 68% and 39%.
As noted, both EFS and DRFS were significantly better for patients with pCRs after initial therapy, with hazard ratios of 0.20 (P less than .001) for each comparison.
The predictive value of both EFS and DRFS held true for three of four subtypes studied, including triple-negative breast cancer (hazard ratios 0.17 and 0.16, P less than .001 for each), HR+/HER2– (HRs 0.21, P = .016 for EFS, and 0.22, P = .024 for DRFS), and HR–/HER2+ (HRs 0.10, and 0.14, P less than .001 for each).
However, among patients with HR+/HER2+ (triple-positive) breast cancers, EFS and DRFS rates were high for both patients with pCRs and those without, and the differences did not reach statistical significance. In these patients, the 3-year EFS rates were 96% for pCR and 87% for non pCR (HR, 0.26, P = .054), and the 3-year DRFS was 97% vs. 92% (HR, 0.19, P = 0.80).
“We believe that achieving path CR doing any therapy for any subtype is a sufficient endpoint,” Dr. Yee said. “Given that, we need to develop minimally-invasive techniques such as MRI and biopsy to identify path CR prior to definitive surgery. We need to validate robust MRI and tissue predictors of path CR, and if we can do that, we can begin to de-escalate toxic therapies,” he said.
The converse is also true: For patients who do not experience a path CR, MRI and tissue predictors could help to identify early in the course of therapy those patients who may need alternative treatments, he added.
“I think that this very clearly validates path CR as an incredibly powerful biomarker,” Eric P. Winer, MD, of Dana-Farber Cancer Institute in Boston, said in the question-and-response session following Dr. Yee’s presentation.
Dr. Winer emphasized, however, “that this does not mean that we can use path CR in comparing treatment A and treatment B in a randomized trial to determine that one is better in terms of long-term outcome.”
I-SPY2 is sponsored by the Quantum Leap Healthcare Collaborative, with funding support from the William K Bowes Foundation, Give Breast Cancer the Boot, University of California San Francisco, The Biomarkers consortium, Quintiles, the Breast Cancer Research Foundation, and Safeway. Dr. Yee reported having no relevant disclosures.
op@frontlinemedcom.com
SOURCE: Yee, D et al. SABCS Abstract GS3-08.
REPORTING FROM SABCS 2017
SAN ANTONIO – Pathological complete response (pCR) is an accurate predictor of both event-free and distant recurrence-free survival in patients treated for stage 2 or 3 breast cancers with high risk for recurrence, according to investigators in the adaptive I-SPY2 trial.
Among 746 patients with various types of breast cancer evaluated in an intention-to-treat analysis, 3-year event-free survival (EFS) for those who had a pCR after chemotherapy and definitive surgery was 94%, compared with 76% for those who did not have a pCR.
Similarly, 3-year distant recurrence-free survival (DRFS) was 95% for patients who had a pCR after first-line therapy, compared with 79% for patients who did not, reported Douglas Yee, MD, of the Masonic Cancer Center at the University of Minnesota in Minneapolis.
“We find that path CR is a strong predictor of event-free survival and distance recurrence-free survival in the setting of a multiagent platform trial,” he said at the San Antonio Breast Cancer Symposium.
He explained that pCR is predictive of survival across all tumor subsets – regardless of hormone receptor status, HER2 status, and 70-gene signature (MammaPrint) status – and that pCR as a clinical trial endpoint allows investigators to rapidly evaluate novel therapeutic combinations, with the potential for identifying more effective and ideally less toxic regimens.
I-SPY 2 is a phase 2, adaptively randomized neoadjuvant clinical trial with a shared control arm in which patients receive standard neoadjuvant chemotherapy, and up to four simultaneous investigational arms. The primary endpoint is pCR, defined as no residual invasive cancer in the breast or lymph nodes, assessed according to the Residual Cancer Burden method. The goal is to match therapies with the most responsive breast cancer subtypes.
In the current analysis, the investigators looked at data on 245 patients with hormone receptor-negative and HER2– tumors (HR–/HER2–), 275 with HR-positive/HER2-negative tumors, 77 with HR–/HER2+ tumors, and 149 with tumors positive for both HR and HER2. Respective rates of pCR in these groups were 41%, 18%, 68% and 39%.
As noted, both EFS and DRFS were significantly better for patients with pCRs after initial therapy, with hazard ratios of 0.20 (P less than .001) for each comparison.
The predictive value of both EFS and DRFS held true for three of four subtypes studied, including triple-negative breast cancer (hazard ratios 0.17 and 0.16, P less than .001 for each), HR+/HER2– (HRs 0.21, P = .016 for EFS, and 0.22, P = .024 for DRFS), and HR–/HER2+ (HRs 0.10, and 0.14, P less than .001 for each).
However, among patients with HR+/HER2+ (triple-positive) breast cancers, EFS and DRFS rates were high for both patients with pCRs and those without, and the differences did not reach statistical significance. In these patients, the 3-year EFS rates were 96% for pCR and 87% for non pCR (HR, 0.26, P = .054), and the 3-year DRFS was 97% vs. 92% (HR, 0.19, P = 0.80).
“We believe that achieving path CR doing any therapy for any subtype is a sufficient endpoint,” Dr. Yee said. “Given that, we need to develop minimally-invasive techniques such as MRI and biopsy to identify path CR prior to definitive surgery. We need to validate robust MRI and tissue predictors of path CR, and if we can do that, we can begin to de-escalate toxic therapies,” he said.
The converse is also true: For patients who do not experience a path CR, MRI and tissue predictors could help to identify early in the course of therapy those patients who may need alternative treatments, he added.
“I think that this very clearly validates path CR as an incredibly powerful biomarker,” Eric P. Winer, MD, of Dana-Farber Cancer Institute in Boston, said in the question-and-response session following Dr. Yee’s presentation.
Dr. Winer emphasized, however, “that this does not mean that we can use path CR in comparing treatment A and treatment B in a randomized trial to determine that one is better in terms of long-term outcome.”
I-SPY2 is sponsored by the Quantum Leap Healthcare Collaborative, with funding support from the William K Bowes Foundation, Give Breast Cancer the Boot, University of California San Francisco, The Biomarkers consortium, Quintiles, the Breast Cancer Research Foundation, and Safeway. Dr. Yee reported having no relevant disclosures.
op@frontlinemedcom.com
SOURCE: Yee, D et al. SABCS Abstract GS3-08.
REPORTING FROM SABCS 2017
SAN ANTONIO – Pathological complete response (pCR) is an accurate predictor of both event-free and distant recurrence-free survival in patients treated for stage 2 or 3 breast cancers with high risk for recurrence, according to investigators in the adaptive I-SPY2 trial.
Among 746 patients with various types of breast cancer evaluated in an intention-to-treat analysis, 3-year event-free survival (EFS) for those who had a pCR after chemotherapy and definitive surgery was 94%, compared with 76% for those who did not have a pCR.
Similarly, 3-year distant recurrence-free survival (DRFS) was 95% for patients who had a pCR after first-line therapy, compared with 79% for patients who did not, reported Douglas Yee, MD, of the Masonic Cancer Center at the University of Minnesota in Minneapolis.
“We find that path CR is a strong predictor of event-free survival and distance recurrence-free survival in the setting of a multiagent platform trial,” he said at the San Antonio Breast Cancer Symposium.
He explained that pCR is predictive of survival across all tumor subsets – regardless of hormone receptor status, HER2 status, and 70-gene signature (MammaPrint) status – and that pCR as a clinical trial endpoint allows investigators to rapidly evaluate novel therapeutic combinations, with the potential for identifying more effective and ideally less toxic regimens.
I-SPY 2 is a phase 2, adaptively randomized neoadjuvant clinical trial with a shared control arm in which patients receive standard neoadjuvant chemotherapy, and up to four simultaneous investigational arms. The primary endpoint is pCR, defined as no residual invasive cancer in the breast or lymph nodes, assessed according to the Residual Cancer Burden method. The goal is to match therapies with the most responsive breast cancer subtypes.
In the current analysis, the investigators looked at data on 245 patients with hormone receptor-negative and HER2– tumors (HR–/HER2–), 275 with HR-positive/HER2-negative tumors, 77 with HR–/HER2+ tumors, and 149 with tumors positive for both HR and HER2. Respective rates of pCR in these groups were 41%, 18%, 68% and 39%.
As noted, both EFS and DRFS were significantly better for patients with pCRs after initial therapy, with hazard ratios of 0.20 (P less than .001) for each comparison.
The predictive value of both EFS and DRFS held true for three of four subtypes studied, including triple-negative breast cancer (hazard ratios 0.17 and 0.16, P less than .001 for each), HR+/HER2– (HRs 0.21, P = .016 for EFS, and 0.22, P = .024 for DRFS), and HR–/HER2+ (HRs 0.10, and 0.14, P less than .001 for each).
However, among patients with HR+/HER2+ (triple-positive) breast cancers, EFS and DRFS rates were high for both patients with pCRs and those without, and the differences did not reach statistical significance. In these patients, the 3-year EFS rates were 96% for pCR and 87% for non pCR (HR, 0.26, P = .054), and the 3-year DRFS was 97% vs. 92% (HR, 0.19, P = 0.80).
“We believe that achieving path CR doing any therapy for any subtype is a sufficient endpoint,” Dr. Yee said. “Given that, we need to develop minimally-invasive techniques such as MRI and biopsy to identify path CR prior to definitive surgery. We need to validate robust MRI and tissue predictors of path CR, and if we can do that, we can begin to de-escalate toxic therapies,” he said.
The converse is also true: For patients who do not experience a path CR, MRI and tissue predictors could help to identify early in the course of therapy those patients who may need alternative treatments, he added.
“I think that this very clearly validates path CR as an incredibly powerful biomarker,” Eric P. Winer, MD, of Dana-Farber Cancer Institute in Boston, said in the question-and-response session following Dr. Yee’s presentation.
Dr. Winer emphasized, however, “that this does not mean that we can use path CR in comparing treatment A and treatment B in a randomized trial to determine that one is better in terms of long-term outcome.”
I-SPY2 is sponsored by the Quantum Leap Healthcare Collaborative, with funding support from the William K Bowes Foundation, Give Breast Cancer the Boot, University of California San Francisco, The Biomarkers consortium, Quintiles, the Breast Cancer Research Foundation, and Safeway. Dr. Yee reported having no relevant disclosures.
op@frontlinemedcom.com
SOURCE: Yee, D et al. SABCS Abstract GS3-08.
Cannabidiol linked to reduction in psychotic symptoms in schizophrenia
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Patients with schizophrenia showed signs of improvement in positive psychotic symptoms and clinician-rated improvement after treatment with cannabidiol, a component of cannabis thought to counteract the effects of tetrahydrocannabinol (THC), an industry-funded phase 2 study reported.
According to the authors, the study is only the second to examine the use of cannabidiol in schizophrenia. “Because cannabidiol acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” wrote the study authors, including several employees of the drugmaker that helped to fund the research.
The study, led by Philip McGuire, FMedSci., of King’s College London, was published online Dec. 15 in the American Journal of Psychiatry.
Researchers have long been interested in the relationship between aspects of schizophrenia – especially psychosis – and cannabis. There’s been less focus on the effects of individual cannabinoids – components of cannabis such as THC (which is psychoactive), cannabinol (which is linked to sleep), and cannabidiol.
Researchers have linked cannabidiol to anxiety relief, and it’s been used to treat a wide variety of conditions, particularly epilepsy.
For the current study, a randomized, double-blind parallel-group trial, researchers assigned patients with schizophrenia or related psychotic disorders to receive 1,000 mg/day of cannabidiol (n = 43) or placebo (n = 45) for 6 weeks. The patients took the drug (10 mL of a 100-mg/mL oral solution) or a matching placebo twice a day in divided doses. They continued to take their existing antipsychotic medication; the study did not accept anyone taking more than one medication for that purpose.
The patients, aged 18-65, were at 15 hospitals in the United Kingdom, Romania, and Poland; 93% of the subjects were white, and 58% were male. The subjects were allowed to continue the use of alcohol or cannabis.
Eighty-three patients finished the trial after two withdrew because of adverse events and three withdrew consent. The intention-to-treat analysis involved 86 patients: 42 who took cannabidiol (including 3 who took it for 21 or fewer days) and 44 who took the placebo. At the end of treatment, the researchers found that the positive score on the Positive and Negative Syndrome Scale (PANSS) fell from baseline by a mean –1.7 points in the placebo group and –3.2 points in the cannabidiol group, a difference of –1.4 points (P = .019). PANSS total and general scores also fell in both groups, as did the Scale for the Assessment of Negative Symptoms score, but the differences between the groups were not statistically significant. PANSS negative scores fell by about the same level in both groups.
At the end of treatment, clinicians were more likely to rate subjects in the cannabidiol group as improved on the Clinical Global Impressions (CGI) Scale (P = 0.018), compared with those in the placebo group.
About 35% of patients in both groups reported adverse events, including gastrointestinal problems (21% of those in the cannabidiol group and 6.7% of those in the placebo group). Researchers determined that just 10 patients in each group had treatment-related adverse events.
The mechanism of action of cannabidiol is unclear. Its effects “do not appear to depend on dopamine D2 receptor antagonism,” the investigators said. Theories about its mechanism of action include inhibition of the fatty acid amide hydrolase, inhibition of adenosine reuptake, TRPV1 and 5-hydroxytryptamine 1A receptor agonism, and D2High partial agonism. “Because [cannabidiol] acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” the authors wrote.
The investigators acknowledged that the study has limitations. For example, nearly all the participants were white. And although research suggests that cannabis use is very common in patients with schizophrenia, the study authors reported that only three patients tested positive for THC at baseline. “Because so few patients tested positive for THC, it was not possible to assess whether the effects of cannabidiol were influenced by cannabis use,” the authors wrote.
GW Research funded the trial and supplied the investigational medicinal product. Other study funders included the National Institute for Health Research Biomedical Research Center at South London, Maudsley NHS Foundation Trust, and King’s College London. Four of the authors are employees of GW Pharmaceuticals and hold shares in the company; one of the four is a cosignatory on a patent for the use of cannabinoids in combination with aripiprazole. Two of the other authors reported various disclosures, including funding from GW Pharmaceuticals. Another two study authors reported no relevant disclosures.
cpnews@frontlinemedcom.com
SOURCE: McGuire P et al. Am J Psychiatry. 2017 Dec 15. doi: 10.1176/appi.ajp.2017.17030325
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Patients with schizophrenia showed signs of improvement in positive psychotic symptoms and clinician-rated improvement after treatment with cannabidiol, a component of cannabis thought to counteract the effects of tetrahydrocannabinol (THC), an industry-funded phase 2 study reported.
According to the authors, the study is only the second to examine the use of cannabidiol in schizophrenia. “Because cannabidiol acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” wrote the study authors, including several employees of the drugmaker that helped to fund the research.
The study, led by Philip McGuire, FMedSci., of King’s College London, was published online Dec. 15 in the American Journal of Psychiatry.
Researchers have long been interested in the relationship between aspects of schizophrenia – especially psychosis – and cannabis. There’s been less focus on the effects of individual cannabinoids – components of cannabis such as THC (which is psychoactive), cannabinol (which is linked to sleep), and cannabidiol.
Researchers have linked cannabidiol to anxiety relief, and it’s been used to treat a wide variety of conditions, particularly epilepsy.
For the current study, a randomized, double-blind parallel-group trial, researchers assigned patients with schizophrenia or related psychotic disorders to receive 1,000 mg/day of cannabidiol (n = 43) or placebo (n = 45) for 6 weeks. The patients took the drug (10 mL of a 100-mg/mL oral solution) or a matching placebo twice a day in divided doses. They continued to take their existing antipsychotic medication; the study did not accept anyone taking more than one medication for that purpose.
The patients, aged 18-65, were at 15 hospitals in the United Kingdom, Romania, and Poland; 93% of the subjects were white, and 58% were male. The subjects were allowed to continue the use of alcohol or cannabis.
Eighty-three patients finished the trial after two withdrew because of adverse events and three withdrew consent. The intention-to-treat analysis involved 86 patients: 42 who took cannabidiol (including 3 who took it for 21 or fewer days) and 44 who took the placebo. At the end of treatment, the researchers found that the positive score on the Positive and Negative Syndrome Scale (PANSS) fell from baseline by a mean –1.7 points in the placebo group and –3.2 points in the cannabidiol group, a difference of –1.4 points (P = .019). PANSS total and general scores also fell in both groups, as did the Scale for the Assessment of Negative Symptoms score, but the differences between the groups were not statistically significant. PANSS negative scores fell by about the same level in both groups.
At the end of treatment, clinicians were more likely to rate subjects in the cannabidiol group as improved on the Clinical Global Impressions (CGI) Scale (P = 0.018), compared with those in the placebo group.
About 35% of patients in both groups reported adverse events, including gastrointestinal problems (21% of those in the cannabidiol group and 6.7% of those in the placebo group). Researchers determined that just 10 patients in each group had treatment-related adverse events.
The mechanism of action of cannabidiol is unclear. Its effects “do not appear to depend on dopamine D2 receptor antagonism,” the investigators said. Theories about its mechanism of action include inhibition of the fatty acid amide hydrolase, inhibition of adenosine reuptake, TRPV1 and 5-hydroxytryptamine 1A receptor agonism, and D2High partial agonism. “Because [cannabidiol] acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” the authors wrote.
The investigators acknowledged that the study has limitations. For example, nearly all the participants were white. And although research suggests that cannabis use is very common in patients with schizophrenia, the study authors reported that only three patients tested positive for THC at baseline. “Because so few patients tested positive for THC, it was not possible to assess whether the effects of cannabidiol were influenced by cannabis use,” the authors wrote.
GW Research funded the trial and supplied the investigational medicinal product. Other study funders included the National Institute for Health Research Biomedical Research Center at South London, Maudsley NHS Foundation Trust, and King’s College London. Four of the authors are employees of GW Pharmaceuticals and hold shares in the company; one of the four is a cosignatory on a patent for the use of cannabinoids in combination with aripiprazole. Two of the other authors reported various disclosures, including funding from GW Pharmaceuticals. Another two study authors reported no relevant disclosures.
cpnews@frontlinemedcom.com
SOURCE: McGuire P et al. Am J Psychiatry. 2017 Dec 15. doi: 10.1176/appi.ajp.2017.17030325
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Patients with schizophrenia showed signs of improvement in positive psychotic symptoms and clinician-rated improvement after treatment with cannabidiol, a component of cannabis thought to counteract the effects of tetrahydrocannabinol (THC), an industry-funded phase 2 study reported.
According to the authors, the study is only the second to examine the use of cannabidiol in schizophrenia. “Because cannabidiol acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” wrote the study authors, including several employees of the drugmaker that helped to fund the research.
The study, led by Philip McGuire, FMedSci., of King’s College London, was published online Dec. 15 in the American Journal of Psychiatry.
Researchers have long been interested in the relationship between aspects of schizophrenia – especially psychosis – and cannabis. There’s been less focus on the effects of individual cannabinoids – components of cannabis such as THC (which is psychoactive), cannabinol (which is linked to sleep), and cannabidiol.
Researchers have linked cannabidiol to anxiety relief, and it’s been used to treat a wide variety of conditions, particularly epilepsy.
For the current study, a randomized, double-blind parallel-group trial, researchers assigned patients with schizophrenia or related psychotic disorders to receive 1,000 mg/day of cannabidiol (n = 43) or placebo (n = 45) for 6 weeks. The patients took the drug (10 mL of a 100-mg/mL oral solution) or a matching placebo twice a day in divided doses. They continued to take their existing antipsychotic medication; the study did not accept anyone taking more than one medication for that purpose.
The patients, aged 18-65, were at 15 hospitals in the United Kingdom, Romania, and Poland; 93% of the subjects were white, and 58% were male. The subjects were allowed to continue the use of alcohol or cannabis.
Eighty-three patients finished the trial after two withdrew because of adverse events and three withdrew consent. The intention-to-treat analysis involved 86 patients: 42 who took cannabidiol (including 3 who took it for 21 or fewer days) and 44 who took the placebo. At the end of treatment, the researchers found that the positive score on the Positive and Negative Syndrome Scale (PANSS) fell from baseline by a mean –1.7 points in the placebo group and –3.2 points in the cannabidiol group, a difference of –1.4 points (P = .019). PANSS total and general scores also fell in both groups, as did the Scale for the Assessment of Negative Symptoms score, but the differences between the groups were not statistically significant. PANSS negative scores fell by about the same level in both groups.
At the end of treatment, clinicians were more likely to rate subjects in the cannabidiol group as improved on the Clinical Global Impressions (CGI) Scale (P = 0.018), compared with those in the placebo group.
About 35% of patients in both groups reported adverse events, including gastrointestinal problems (21% of those in the cannabidiol group and 6.7% of those in the placebo group). Researchers determined that just 10 patients in each group had treatment-related adverse events.
The mechanism of action of cannabidiol is unclear. Its effects “do not appear to depend on dopamine D2 receptor antagonism,” the investigators said. Theories about its mechanism of action include inhibition of the fatty acid amide hydrolase, inhibition of adenosine reuptake, TRPV1 and 5-hydroxytryptamine 1A receptor agonism, and D2High partial agonism. “Because [cannabidiol] acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” the authors wrote.
The investigators acknowledged that the study has limitations. For example, nearly all the participants were white. And although research suggests that cannabis use is very common in patients with schizophrenia, the study authors reported that only three patients tested positive for THC at baseline. “Because so few patients tested positive for THC, it was not possible to assess whether the effects of cannabidiol were influenced by cannabis use,” the authors wrote.
GW Research funded the trial and supplied the investigational medicinal product. Other study funders included the National Institute for Health Research Biomedical Research Center at South London, Maudsley NHS Foundation Trust, and King’s College London. Four of the authors are employees of GW Pharmaceuticals and hold shares in the company; one of the four is a cosignatory on a patent for the use of cannabinoids in combination with aripiprazole. Two of the other authors reported various disclosures, including funding from GW Pharmaceuticals. Another two study authors reported no relevant disclosures.
cpnews@frontlinemedcom.com
SOURCE: McGuire P et al. Am J Psychiatry. 2017 Dec 15. doi: 10.1176/appi.ajp.2017.17030325
AHA: Childhood adversity strongly linked to poorer health outcomes
Research suggests an association between adverse childhood events and poorer cardiometabolic health across the lifespan, a new scientific statement from the American Heart Association declares, although it acknowledges various limitations in understanding the connection.
Studies haven’t confirmed a cause-and-effect relationship or the full extent of excess risk, and it’s not clear why some people who experience childhood trauma are more resilient than others. There’s also scant information about any link to higher cardiometabolic death rates.
For the new statement, which appears in Circulation, researchers reviewed recent systematic reviews into the links between childhood adversity – including events like violence and abuse – and cardiometabolic outcome.
By one estimate, nearly 60% of adults in the United States experienced at least one adverse childhood event. According to the statement, reviews have linked childhood adversity to higher risks of cardiac death and outcomes like heart attack and stroke. They’ve also linked adversity to risk factors like high blood pressure, obesity, and type 2 diabetes.
the statement said. However, Dr. Suglia noted that research into mortality is limited.
The level of higher risk varies by study and outcome, and no one knows if there’s a cause-and-effect link. “As you can imagine, child adversity is not an exposure that lends itself to randomized trials,” she said. “On top of that, we are talking about health effects that take many years to manifest so we rely on observational studies.”
However, “while there is a possibility that there is an alternate factor that is responsible for these associations, the evidence is consistent across different populations,” said Dr. Suglia of Emory University in Atlanta. “And in general, studies do consider alternative factors that may be associated with both child adversity and cardiovascular health, further strengthening inferences we can make from the observational studies.”
Why might the association exist? “The mechanisms that drive these associations are still not fully elucidated but we hypothesize three pathways that may mediate these associations: behavioral factors (diet, sleep, physical activity, smoking), biological (hypothalamic-pituitary-adrenal axis dysregulation, epigenetic, chronic inflammation), and mental health (posttraumatic stress disorder and depression),” she said.
The statement notes that research is limited into why some people thrive on the cardiometabolic front despite childhood adversity. “One of the recommendations is that we need to focus more on factors that could inform prevention and intervention efforts so that those that are affected by adversity in childhood are not also affected by adverse cardiovascular events,” Dr. Suglia said.
The statement also notes that there’s been only limited research into modifiers of vulnerability to the effects of childhood adversity, such as gender, race/ethnicity, genetics, and community characteristics. And it says there’s been little study of how early interventions may affect cardiometabolic outcomes: “Additional research, including longitudinal prospective studies, designed to guide and inform effective and timely individual/clinical and population-level preventive interventions is required.”
Dr. Suglia reports a research grant from the National Heart, Lung, and Blood Institute. Most of the other statement coauthors report no disclosures outside of government funding.
SOURCE: Suglia S et al. Circulation. 2017 Dec 18. doi: 10.1161/CIR.0000000000000536
Research suggests an association between adverse childhood events and poorer cardiometabolic health across the lifespan, a new scientific statement from the American Heart Association declares, although it acknowledges various limitations in understanding the connection.
Studies haven’t confirmed a cause-and-effect relationship or the full extent of excess risk, and it’s not clear why some people who experience childhood trauma are more resilient than others. There’s also scant information about any link to higher cardiometabolic death rates.
For the new statement, which appears in Circulation, researchers reviewed recent systematic reviews into the links between childhood adversity – including events like violence and abuse – and cardiometabolic outcome.
By one estimate, nearly 60% of adults in the United States experienced at least one adverse childhood event. According to the statement, reviews have linked childhood adversity to higher risks of cardiac death and outcomes like heart attack and stroke. They’ve also linked adversity to risk factors like high blood pressure, obesity, and type 2 diabetes.
the statement said. However, Dr. Suglia noted that research into mortality is limited.
The level of higher risk varies by study and outcome, and no one knows if there’s a cause-and-effect link. “As you can imagine, child adversity is not an exposure that lends itself to randomized trials,” she said. “On top of that, we are talking about health effects that take many years to manifest so we rely on observational studies.”
However, “while there is a possibility that there is an alternate factor that is responsible for these associations, the evidence is consistent across different populations,” said Dr. Suglia of Emory University in Atlanta. “And in general, studies do consider alternative factors that may be associated with both child adversity and cardiovascular health, further strengthening inferences we can make from the observational studies.”
Why might the association exist? “The mechanisms that drive these associations are still not fully elucidated but we hypothesize three pathways that may mediate these associations: behavioral factors (diet, sleep, physical activity, smoking), biological (hypothalamic-pituitary-adrenal axis dysregulation, epigenetic, chronic inflammation), and mental health (posttraumatic stress disorder and depression),” she said.
The statement notes that research is limited into why some people thrive on the cardiometabolic front despite childhood adversity. “One of the recommendations is that we need to focus more on factors that could inform prevention and intervention efforts so that those that are affected by adversity in childhood are not also affected by adverse cardiovascular events,” Dr. Suglia said.
The statement also notes that there’s been only limited research into modifiers of vulnerability to the effects of childhood adversity, such as gender, race/ethnicity, genetics, and community characteristics. And it says there’s been little study of how early interventions may affect cardiometabolic outcomes: “Additional research, including longitudinal prospective studies, designed to guide and inform effective and timely individual/clinical and population-level preventive interventions is required.”
Dr. Suglia reports a research grant from the National Heart, Lung, and Blood Institute. Most of the other statement coauthors report no disclosures outside of government funding.
SOURCE: Suglia S et al. Circulation. 2017 Dec 18. doi: 10.1161/CIR.0000000000000536
Research suggests an association between adverse childhood events and poorer cardiometabolic health across the lifespan, a new scientific statement from the American Heart Association declares, although it acknowledges various limitations in understanding the connection.
Studies haven’t confirmed a cause-and-effect relationship or the full extent of excess risk, and it’s not clear why some people who experience childhood trauma are more resilient than others. There’s also scant information about any link to higher cardiometabolic death rates.
For the new statement, which appears in Circulation, researchers reviewed recent systematic reviews into the links between childhood adversity – including events like violence and abuse – and cardiometabolic outcome.
By one estimate, nearly 60% of adults in the United States experienced at least one adverse childhood event. According to the statement, reviews have linked childhood adversity to higher risks of cardiac death and outcomes like heart attack and stroke. They’ve also linked adversity to risk factors like high blood pressure, obesity, and type 2 diabetes.
the statement said. However, Dr. Suglia noted that research into mortality is limited.
The level of higher risk varies by study and outcome, and no one knows if there’s a cause-and-effect link. “As you can imagine, child adversity is not an exposure that lends itself to randomized trials,” she said. “On top of that, we are talking about health effects that take many years to manifest so we rely on observational studies.”
However, “while there is a possibility that there is an alternate factor that is responsible for these associations, the evidence is consistent across different populations,” said Dr. Suglia of Emory University in Atlanta. “And in general, studies do consider alternative factors that may be associated with both child adversity and cardiovascular health, further strengthening inferences we can make from the observational studies.”
Why might the association exist? “The mechanisms that drive these associations are still not fully elucidated but we hypothesize three pathways that may mediate these associations: behavioral factors (diet, sleep, physical activity, smoking), biological (hypothalamic-pituitary-adrenal axis dysregulation, epigenetic, chronic inflammation), and mental health (posttraumatic stress disorder and depression),” she said.
The statement notes that research is limited into why some people thrive on the cardiometabolic front despite childhood adversity. “One of the recommendations is that we need to focus more on factors that could inform prevention and intervention efforts so that those that are affected by adversity in childhood are not also affected by adverse cardiovascular events,” Dr. Suglia said.
The statement also notes that there’s been only limited research into modifiers of vulnerability to the effects of childhood adversity, such as gender, race/ethnicity, genetics, and community characteristics. And it says there’s been little study of how early interventions may affect cardiometabolic outcomes: “Additional research, including longitudinal prospective studies, designed to guide and inform effective and timely individual/clinical and population-level preventive interventions is required.”
Dr. Suglia reports a research grant from the National Heart, Lung, and Blood Institute. Most of the other statement coauthors report no disclosures outside of government funding.
SOURCE: Suglia S et al. Circulation. 2017 Dec 18. doi: 10.1161/CIR.0000000000000536
FROM CIRCULATION
New anticoagulants pose challenges for surgeons
SAN DIEGO – A new class of is now commonly seen in patients and can require new strategies for management in the surgical setting. New drugs to reverse anticoagulation agents now need to be routinely considered in advance of surgery.
“They’re all over the place. It feels like everyone I see is on an anticoagulant, especially the new anticoagulants,” said Carlos V.R. Brown, MD, FACS, associate professor of surgery and chief of the division of acute care surgery at the University of Texas at Austin. “There’s a lot more learning that has to take place into how these medications work and how to take care of patients who use them.”
“Warfarin is slow, unpredictable, and requires monitoring and dose adjustment,” he said. In addition, interactions with food and other medications can be problematic, he said. The injectable drug heparin, meanwhile, requires monitoring and frequent dose adjustments, he said. “We’re in search of the ideal anticoagulant – one that’s oral, has a wide therapeutic window, is very predictable with rapid onset, and has minimal interaction with other food or drugs.”
Here’s the hitch, he said: “It probably doesn’t exist.”
There are now several alternatives to the old standbys on the market. One class, the direct thrombin inhibitor, is led by dabigatran etexilate (Pradaxa). Another class, the factor Xa inhibitors, includes rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa). From an elective surgery standpoint, Dr. Brown said in an interview, it has become important to understand how to reverse the effects of anticoagulants before a procedure.
To determine levels of the drugs, a TT (thrombin time) screening test is recommended for dabigatran and an anti-Xa test for rivaroxaban, apixaban, and edoxaban said Dr. Brown, referring to a 2017 study published in Critical Care Clinics. The paper summarized the available evidence and provided the optimal reversal strategy for bleeding patients with trauma on novel oral anticoagulants. The report also noted that newer blood thinners have a half-life of 7 or 12 hours and reach peak plasma level at 1-4 hours, depending on the medication (Crit Care Clin. 2017;33[1]135-52).
There may be no time to determine blood thinner levels in emergency situations. In those cases, patient or caregiver history about recent doses can be crucial, Dr. Brown said. “Knowing the patient’s history is going to be a key component,” he said.
Surgeons can turn to a variety of options to reverse the newer anticoagulants in an emergent setting, but only dabigatran has a Food and Drug Administration–approved reversal agent. Activated charcoal, PCC (Kcentra) and aPCC (FEIBA) can reverse dabigatran and oral factor Xa inhibitors, Dr. Brown said. Dialysis is also an option for dabigatran.
Another option to reverse dabigatran may be idarucizumab (Praxbind), a reversal agent. A 2017 industry-funded, open-label study reported successful results. It has been shown to work rapidly, Dr. Brown said, and the drug is now FDA approved (N Engl J Med. 2017 Aug 3;377[5]:431-41).
For oral factor Xa inhibitors, Dr. Brown said, andexanet alfa is now in a trial and doesn’t yet have FDA approval. “Presumably, it will provide a benefit over PCC because it’s directed at that specific medication,” he said.
Dr. Brown cautioned about the risks of reversing anticoagulants. “Any time you’re reversing an anticoagulant, the side effect is going to be clotting,” boosting the likelihood of events such as heart attack or stroke, he said. “You’re always weighing the risk versus the benefit of reversing.”
Dr. Brown has no relevant disclosures.
SAN DIEGO – A new class of is now commonly seen in patients and can require new strategies for management in the surgical setting. New drugs to reverse anticoagulation agents now need to be routinely considered in advance of surgery.
“They’re all over the place. It feels like everyone I see is on an anticoagulant, especially the new anticoagulants,” said Carlos V.R. Brown, MD, FACS, associate professor of surgery and chief of the division of acute care surgery at the University of Texas at Austin. “There’s a lot more learning that has to take place into how these medications work and how to take care of patients who use them.”
“Warfarin is slow, unpredictable, and requires monitoring and dose adjustment,” he said. In addition, interactions with food and other medications can be problematic, he said. The injectable drug heparin, meanwhile, requires monitoring and frequent dose adjustments, he said. “We’re in search of the ideal anticoagulant – one that’s oral, has a wide therapeutic window, is very predictable with rapid onset, and has minimal interaction with other food or drugs.”
Here’s the hitch, he said: “It probably doesn’t exist.”
There are now several alternatives to the old standbys on the market. One class, the direct thrombin inhibitor, is led by dabigatran etexilate (Pradaxa). Another class, the factor Xa inhibitors, includes rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa). From an elective surgery standpoint, Dr. Brown said in an interview, it has become important to understand how to reverse the effects of anticoagulants before a procedure.
To determine levels of the drugs, a TT (thrombin time) screening test is recommended for dabigatran and an anti-Xa test for rivaroxaban, apixaban, and edoxaban said Dr. Brown, referring to a 2017 study published in Critical Care Clinics. The paper summarized the available evidence and provided the optimal reversal strategy for bleeding patients with trauma on novel oral anticoagulants. The report also noted that newer blood thinners have a half-life of 7 or 12 hours and reach peak plasma level at 1-4 hours, depending on the medication (Crit Care Clin. 2017;33[1]135-52).
There may be no time to determine blood thinner levels in emergency situations. In those cases, patient or caregiver history about recent doses can be crucial, Dr. Brown said. “Knowing the patient’s history is going to be a key component,” he said.
Surgeons can turn to a variety of options to reverse the newer anticoagulants in an emergent setting, but only dabigatran has a Food and Drug Administration–approved reversal agent. Activated charcoal, PCC (Kcentra) and aPCC (FEIBA) can reverse dabigatran and oral factor Xa inhibitors, Dr. Brown said. Dialysis is also an option for dabigatran.
Another option to reverse dabigatran may be idarucizumab (Praxbind), a reversal agent. A 2017 industry-funded, open-label study reported successful results. It has been shown to work rapidly, Dr. Brown said, and the drug is now FDA approved (N Engl J Med. 2017 Aug 3;377[5]:431-41).
For oral factor Xa inhibitors, Dr. Brown said, andexanet alfa is now in a trial and doesn’t yet have FDA approval. “Presumably, it will provide a benefit over PCC because it’s directed at that specific medication,” he said.
Dr. Brown cautioned about the risks of reversing anticoagulants. “Any time you’re reversing an anticoagulant, the side effect is going to be clotting,” boosting the likelihood of events such as heart attack or stroke, he said. “You’re always weighing the risk versus the benefit of reversing.”
Dr. Brown has no relevant disclosures.
SAN DIEGO – A new class of is now commonly seen in patients and can require new strategies for management in the surgical setting. New drugs to reverse anticoagulation agents now need to be routinely considered in advance of surgery.
“They’re all over the place. It feels like everyone I see is on an anticoagulant, especially the new anticoagulants,” said Carlos V.R. Brown, MD, FACS, associate professor of surgery and chief of the division of acute care surgery at the University of Texas at Austin. “There’s a lot more learning that has to take place into how these medications work and how to take care of patients who use them.”
“Warfarin is slow, unpredictable, and requires monitoring and dose adjustment,” he said. In addition, interactions with food and other medications can be problematic, he said. The injectable drug heparin, meanwhile, requires monitoring and frequent dose adjustments, he said. “We’re in search of the ideal anticoagulant – one that’s oral, has a wide therapeutic window, is very predictable with rapid onset, and has minimal interaction with other food or drugs.”
Here’s the hitch, he said: “It probably doesn’t exist.”
There are now several alternatives to the old standbys on the market. One class, the direct thrombin inhibitor, is led by dabigatran etexilate (Pradaxa). Another class, the factor Xa inhibitors, includes rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa). From an elective surgery standpoint, Dr. Brown said in an interview, it has become important to understand how to reverse the effects of anticoagulants before a procedure.
To determine levels of the drugs, a TT (thrombin time) screening test is recommended for dabigatran and an anti-Xa test for rivaroxaban, apixaban, and edoxaban said Dr. Brown, referring to a 2017 study published in Critical Care Clinics. The paper summarized the available evidence and provided the optimal reversal strategy for bleeding patients with trauma on novel oral anticoagulants. The report also noted that newer blood thinners have a half-life of 7 or 12 hours and reach peak plasma level at 1-4 hours, depending on the medication (Crit Care Clin. 2017;33[1]135-52).
There may be no time to determine blood thinner levels in emergency situations. In those cases, patient or caregiver history about recent doses can be crucial, Dr. Brown said. “Knowing the patient’s history is going to be a key component,” he said.
Surgeons can turn to a variety of options to reverse the newer anticoagulants in an emergent setting, but only dabigatran has a Food and Drug Administration–approved reversal agent. Activated charcoal, PCC (Kcentra) and aPCC (FEIBA) can reverse dabigatran and oral factor Xa inhibitors, Dr. Brown said. Dialysis is also an option for dabigatran.
Another option to reverse dabigatran may be idarucizumab (Praxbind), a reversal agent. A 2017 industry-funded, open-label study reported successful results. It has been shown to work rapidly, Dr. Brown said, and the drug is now FDA approved (N Engl J Med. 2017 Aug 3;377[5]:431-41).
For oral factor Xa inhibitors, Dr. Brown said, andexanet alfa is now in a trial and doesn’t yet have FDA approval. “Presumably, it will provide a benefit over PCC because it’s directed at that specific medication,” he said.
Dr. Brown cautioned about the risks of reversing anticoagulants. “Any time you’re reversing an anticoagulant, the side effect is going to be clotting,” boosting the likelihood of events such as heart attack or stroke, he said. “You’re always weighing the risk versus the benefit of reversing.”
Dr. Brown has no relevant disclosures.
EXPERT OPINION FROM THE ACS CLINICAL CONGRESS
More evidence links high-potency marijuana use to first-episode psychosis
SAN DIEGO – High-potency marijuana use appears to be associated with an increased risk of a first psychotic episode, based on a case-control study conducted in Europe.
“Daily users of a strong type of cannabis face a significant increase in the probability of developing a psychotic disorder,” reported Marta Di Forti, MD, PhD, MRC, lead author of a study whose preliminary results were presented at the International Congress on Schizophrenia Research.
Dr. Di Forti spawned a media boomlet in 2015 when she and her colleagues raised the prospect of a possible association between so-called “skunk” marijuana and first psychotic episodes. In their study of subjects in London with first-time psychotic episodes and matched population controls, those who had psychotic episodes were three times (adjusted odds ratio: 2.92; 95% confidence interval, 1.52-3.45; P = .001) as likely as controls to have used “skunk” marijuana (Lancet Psychiatry. 2015 Mar;2[3]:233-8).
In the new study, Dr. Di Forti and her colleagues analyzed 1,200 first-incident cases of psychosis that were captured between the years 2010 and 2013 by the European Network of National Schizophrenia Networks Studying Gene-Environment Interactions project (EU-GEI). The researchers compared the cases to 1,300 population-based controls in five unidentified European countries and found that daily users of high-potency marijuana had the highest adjusted odds ratio (4.5-8, statistical significance not available) of a psychotic episode (Schizophr Bull. 2017 Mar:43:S30. doi: 10.1093/schbul/sbx021.078). “This effect is significant even after controlling for other drugs of abuse such as stimulants, tobacco and alcohol, and main sociodemographic confounders,” the researchers wrote in their abstract.
“The biology of cannabis-associated psychosis is still unclear,” Dr. Di Forti said in an interview. “Nevertheless, we know that THC (tetrahydrocannabinol) binds with two receptors called CB1 and CB2. They’re part of the endocannabinoid system, which from uterus onward protects our central nervous systems from insults. It activates on demand if the brain goes on hypoxia or we experience a brain injury.”
“CB1 activation leads to changes in the transmission of both GABA and glutamate. Downstream, they affect the dopamine system, which is biologically linked to psychosis.”
Dr. Di Forti dismissed the idea that people at risk for psychosis are drawn to high-potency marijuana. “Using genetic data, we’ve showed that cannabis users – both cases and controls – did not have a higher genetic load for schizophrenia than those who never used (marijuana),” she said (Lancet Psychiatry. 2015 May;2[5]:381-2).
The findings point to the importance of asking patients – and students and children – about more than just whether they have ever used marijuana. History-taking for marijuana use needs to be comparable to that performed for alcohol use, she said. “I always ask my patients for details about their past and present use but also try to understand why they use (marijuana). When possible, once I know how frequently and what type (of marijuana) they use, I can negotiate some harm-reduction strategy.”
The study is funded by the U.K.’s Medical Research Council and a European Union grant. Dr. Di Forti reports no relevant disclosures.
SAN DIEGO – High-potency marijuana use appears to be associated with an increased risk of a first psychotic episode, based on a case-control study conducted in Europe.
“Daily users of a strong type of cannabis face a significant increase in the probability of developing a psychotic disorder,” reported Marta Di Forti, MD, PhD, MRC, lead author of a study whose preliminary results were presented at the International Congress on Schizophrenia Research.
Dr. Di Forti spawned a media boomlet in 2015 when she and her colleagues raised the prospect of a possible association between so-called “skunk” marijuana and first psychotic episodes. In their study of subjects in London with first-time psychotic episodes and matched population controls, those who had psychotic episodes were three times (adjusted odds ratio: 2.92; 95% confidence interval, 1.52-3.45; P = .001) as likely as controls to have used “skunk” marijuana (Lancet Psychiatry. 2015 Mar;2[3]:233-8).
In the new study, Dr. Di Forti and her colleagues analyzed 1,200 first-incident cases of psychosis that were captured between the years 2010 and 2013 by the European Network of National Schizophrenia Networks Studying Gene-Environment Interactions project (EU-GEI). The researchers compared the cases to 1,300 population-based controls in five unidentified European countries and found that daily users of high-potency marijuana had the highest adjusted odds ratio (4.5-8, statistical significance not available) of a psychotic episode (Schizophr Bull. 2017 Mar:43:S30. doi: 10.1093/schbul/sbx021.078). “This effect is significant even after controlling for other drugs of abuse such as stimulants, tobacco and alcohol, and main sociodemographic confounders,” the researchers wrote in their abstract.
“The biology of cannabis-associated psychosis is still unclear,” Dr. Di Forti said in an interview. “Nevertheless, we know that THC (tetrahydrocannabinol) binds with two receptors called CB1 and CB2. They’re part of the endocannabinoid system, which from uterus onward protects our central nervous systems from insults. It activates on demand if the brain goes on hypoxia or we experience a brain injury.”
“CB1 activation leads to changes in the transmission of both GABA and glutamate. Downstream, they affect the dopamine system, which is biologically linked to psychosis.”
Dr. Di Forti dismissed the idea that people at risk for psychosis are drawn to high-potency marijuana. “Using genetic data, we’ve showed that cannabis users – both cases and controls – did not have a higher genetic load for schizophrenia than those who never used (marijuana),” she said (Lancet Psychiatry. 2015 May;2[5]:381-2).
The findings point to the importance of asking patients – and students and children – about more than just whether they have ever used marijuana. History-taking for marijuana use needs to be comparable to that performed for alcohol use, she said. “I always ask my patients for details about their past and present use but also try to understand why they use (marijuana). When possible, once I know how frequently and what type (of marijuana) they use, I can negotiate some harm-reduction strategy.”
The study is funded by the U.K.’s Medical Research Council and a European Union grant. Dr. Di Forti reports no relevant disclosures.
SAN DIEGO – High-potency marijuana use appears to be associated with an increased risk of a first psychotic episode, based on a case-control study conducted in Europe.
“Daily users of a strong type of cannabis face a significant increase in the probability of developing a psychotic disorder,” reported Marta Di Forti, MD, PhD, MRC, lead author of a study whose preliminary results were presented at the International Congress on Schizophrenia Research.
Dr. Di Forti spawned a media boomlet in 2015 when she and her colleagues raised the prospect of a possible association between so-called “skunk” marijuana and first psychotic episodes. In their study of subjects in London with first-time psychotic episodes and matched population controls, those who had psychotic episodes were three times (adjusted odds ratio: 2.92; 95% confidence interval, 1.52-3.45; P = .001) as likely as controls to have used “skunk” marijuana (Lancet Psychiatry. 2015 Mar;2[3]:233-8).
In the new study, Dr. Di Forti and her colleagues analyzed 1,200 first-incident cases of psychosis that were captured between the years 2010 and 2013 by the European Network of National Schizophrenia Networks Studying Gene-Environment Interactions project (EU-GEI). The researchers compared the cases to 1,300 population-based controls in five unidentified European countries and found that daily users of high-potency marijuana had the highest adjusted odds ratio (4.5-8, statistical significance not available) of a psychotic episode (Schizophr Bull. 2017 Mar:43:S30. doi: 10.1093/schbul/sbx021.078). “This effect is significant even after controlling for other drugs of abuse such as stimulants, tobacco and alcohol, and main sociodemographic confounders,” the researchers wrote in their abstract.
“The biology of cannabis-associated psychosis is still unclear,” Dr. Di Forti said in an interview. “Nevertheless, we know that THC (tetrahydrocannabinol) binds with two receptors called CB1 and CB2. They’re part of the endocannabinoid system, which from uterus onward protects our central nervous systems from insults. It activates on demand if the brain goes on hypoxia or we experience a brain injury.”
“CB1 activation leads to changes in the transmission of both GABA and glutamate. Downstream, they affect the dopamine system, which is biologically linked to psychosis.”
Dr. Di Forti dismissed the idea that people at risk for psychosis are drawn to high-potency marijuana. “Using genetic data, we’ve showed that cannabis users – both cases and controls – did not have a higher genetic load for schizophrenia than those who never used (marijuana),” she said (Lancet Psychiatry. 2015 May;2[5]:381-2).
The findings point to the importance of asking patients – and students and children – about more than just whether they have ever used marijuana. History-taking for marijuana use needs to be comparable to that performed for alcohol use, she said. “I always ask my patients for details about their past and present use but also try to understand why they use (marijuana). When possible, once I know how frequently and what type (of marijuana) they use, I can negotiate some harm-reduction strategy.”
The study is funded by the U.K.’s Medical Research Council and a European Union grant. Dr. Di Forti reports no relevant disclosures.
REPORTING FROM THE ICSR BIENNIAL MEETING
Evidence builds for long-term ineffectiveness of steroid shots for knee OA
SAN DIEGO – Real-world, nontrial research confirms the findings of a high-profile study released earlier in 2017: Corticosteroid shots are ineffective in the long term for knee osteoarthritis. In fact, researchers found a greater likelihood of a worsening condition in knees treated with the injections.
“Our findings are consistent with the latest randomized, controlled trial,” said study coauthor Jie Wei, MD, of Central South University in Changsha, China. She spoke in a plenary presentation about the study findings at the annual meeting of the American College of Rheumatology.
The use of corticosteroids for knee OA is a controversial topic. As Dr. Wei noted, there has been wide disagreement among medical societies about whether the treatment is useful in the long term for patients with pain flare-ups.
For the randomized, controlled study released in 2017, researchers tracked 140 patients aged 45 and older with inflammation of the synovial membrane. They were randomly assigned to injections of intra-articular triamcinolone or a placebo.
After 2 years of injections every 12 weeks, there was no difference in reported pain between the intervention and control groups. Also, those who received injections lost more cartilage (JAMA. 2017 May 16;317[19]:1967-75).
Researchers launched the new study to seek insight through a real-life cohort. They examined findings from the Osteoarthritis Initiative, a longitudinal study of 4,796 patients aged 45-79 at four U.S. clinics with knee OA or high risk of knee OA. Patients underwent annual examinations at baseline and annually for 4 years.
In an adjusted marginal structural analysis, knee replacement or worsening of Kellgren Lawrence grade at the tibial femoral joint was more likely in 149 injection knees than 2,191 noninjection knees (odds ratio, 5.74; 95% confidence interval, 2.01-16.42).
Knee replacement or joint space width worsening at the tibial femoral joint was also more likely in 120 injection knees than 2,112 noninjection knees (OR, 1.64; 95% CI, 0.91-2.93).
In another analysis, researchers tracked 134 injection knees (58 whose OA progressed) and 498 noninjection knees (132 whose OA progressed) for up to 8 years. After adjustment, the injection knees were more likely to have progressed (hazard ratio, 1.60; 95% CI, 1.21-2.12,).
“Several explanations may account for our study findings,” Dr. Wei said. One possibility, she said, is that corticosteroids may hurt chondrocytes by, among other things, inducing apoptosis and synovial membrane inflammation.
It’s also possible, she said, that patients may feel pain relief after injections and subsequently boost the risk of OA progression by increasing their physical activity.
“We need to know what types of physical activities may increase the OA progression,” she said. “Did patients who received steroid injection indeed increase this type of physical activity compared to subjects without steroid injection?”
Dr. Wei noted the study’s limitations, including the fact that patients who received injections had more pain at baseline, potentially indicating they had worse structural lesions that are more susceptible to progression.
The study authors reported no relevant disclosures. The National Natural Science Foundation of China funded the study. The Osteoarthritis Initiative is a partnership between the National Institutes of Health and Merck, Novartis, GlaxoSmithKline, and Pfizer.
SAN DIEGO – Real-world, nontrial research confirms the findings of a high-profile study released earlier in 2017: Corticosteroid shots are ineffective in the long term for knee osteoarthritis. In fact, researchers found a greater likelihood of a worsening condition in knees treated with the injections.
“Our findings are consistent with the latest randomized, controlled trial,” said study coauthor Jie Wei, MD, of Central South University in Changsha, China. She spoke in a plenary presentation about the study findings at the annual meeting of the American College of Rheumatology.
The use of corticosteroids for knee OA is a controversial topic. As Dr. Wei noted, there has been wide disagreement among medical societies about whether the treatment is useful in the long term for patients with pain flare-ups.
For the randomized, controlled study released in 2017, researchers tracked 140 patients aged 45 and older with inflammation of the synovial membrane. They were randomly assigned to injections of intra-articular triamcinolone or a placebo.
After 2 years of injections every 12 weeks, there was no difference in reported pain between the intervention and control groups. Also, those who received injections lost more cartilage (JAMA. 2017 May 16;317[19]:1967-75).
Researchers launched the new study to seek insight through a real-life cohort. They examined findings from the Osteoarthritis Initiative, a longitudinal study of 4,796 patients aged 45-79 at four U.S. clinics with knee OA or high risk of knee OA. Patients underwent annual examinations at baseline and annually for 4 years.
In an adjusted marginal structural analysis, knee replacement or worsening of Kellgren Lawrence grade at the tibial femoral joint was more likely in 149 injection knees than 2,191 noninjection knees (odds ratio, 5.74; 95% confidence interval, 2.01-16.42).
Knee replacement or joint space width worsening at the tibial femoral joint was also more likely in 120 injection knees than 2,112 noninjection knees (OR, 1.64; 95% CI, 0.91-2.93).
In another analysis, researchers tracked 134 injection knees (58 whose OA progressed) and 498 noninjection knees (132 whose OA progressed) for up to 8 years. After adjustment, the injection knees were more likely to have progressed (hazard ratio, 1.60; 95% CI, 1.21-2.12,).
“Several explanations may account for our study findings,” Dr. Wei said. One possibility, she said, is that corticosteroids may hurt chondrocytes by, among other things, inducing apoptosis and synovial membrane inflammation.
It’s also possible, she said, that patients may feel pain relief after injections and subsequently boost the risk of OA progression by increasing their physical activity.
“We need to know what types of physical activities may increase the OA progression,” she said. “Did patients who received steroid injection indeed increase this type of physical activity compared to subjects without steroid injection?”
Dr. Wei noted the study’s limitations, including the fact that patients who received injections had more pain at baseline, potentially indicating they had worse structural lesions that are more susceptible to progression.
The study authors reported no relevant disclosures. The National Natural Science Foundation of China funded the study. The Osteoarthritis Initiative is a partnership between the National Institutes of Health and Merck, Novartis, GlaxoSmithKline, and Pfizer.
SAN DIEGO – Real-world, nontrial research confirms the findings of a high-profile study released earlier in 2017: Corticosteroid shots are ineffective in the long term for knee osteoarthritis. In fact, researchers found a greater likelihood of a worsening condition in knees treated with the injections.
“Our findings are consistent with the latest randomized, controlled trial,” said study coauthor Jie Wei, MD, of Central South University in Changsha, China. She spoke in a plenary presentation about the study findings at the annual meeting of the American College of Rheumatology.
The use of corticosteroids for knee OA is a controversial topic. As Dr. Wei noted, there has been wide disagreement among medical societies about whether the treatment is useful in the long term for patients with pain flare-ups.
For the randomized, controlled study released in 2017, researchers tracked 140 patients aged 45 and older with inflammation of the synovial membrane. They were randomly assigned to injections of intra-articular triamcinolone or a placebo.
After 2 years of injections every 12 weeks, there was no difference in reported pain between the intervention and control groups. Also, those who received injections lost more cartilage (JAMA. 2017 May 16;317[19]:1967-75).
Researchers launched the new study to seek insight through a real-life cohort. They examined findings from the Osteoarthritis Initiative, a longitudinal study of 4,796 patients aged 45-79 at four U.S. clinics with knee OA or high risk of knee OA. Patients underwent annual examinations at baseline and annually for 4 years.
In an adjusted marginal structural analysis, knee replacement or worsening of Kellgren Lawrence grade at the tibial femoral joint was more likely in 149 injection knees than 2,191 noninjection knees (odds ratio, 5.74; 95% confidence interval, 2.01-16.42).
Knee replacement or joint space width worsening at the tibial femoral joint was also more likely in 120 injection knees than 2,112 noninjection knees (OR, 1.64; 95% CI, 0.91-2.93).
In another analysis, researchers tracked 134 injection knees (58 whose OA progressed) and 498 noninjection knees (132 whose OA progressed) for up to 8 years. After adjustment, the injection knees were more likely to have progressed (hazard ratio, 1.60; 95% CI, 1.21-2.12,).
“Several explanations may account for our study findings,” Dr. Wei said. One possibility, she said, is that corticosteroids may hurt chondrocytes by, among other things, inducing apoptosis and synovial membrane inflammation.
It’s also possible, she said, that patients may feel pain relief after injections and subsequently boost the risk of OA progression by increasing their physical activity.
“We need to know what types of physical activities may increase the OA progression,” she said. “Did patients who received steroid injection indeed increase this type of physical activity compared to subjects without steroid injection?”
Dr. Wei noted the study’s limitations, including the fact that patients who received injections had more pain at baseline, potentially indicating they had worse structural lesions that are more susceptible to progression.
The study authors reported no relevant disclosures. The National Natural Science Foundation of China funded the study. The Osteoarthritis Initiative is a partnership between the National Institutes of Health and Merck, Novartis, GlaxoSmithKline, and Pfizer.
REPORTING FROM ACR 2017
Key clinical point:
Major finding: In adjusted analysis of 134 injection knees and 498 noninjection knees tracked for up to 8 years, OA in injection knees was more likely to have progressed (HR, 1.60; 95% CI, 1.21-2.12).
Study details: Cohort analysis of data from the Osteoarthritis Initiative, which tracked patients with (or at high risk of) knee OA at four U.S. clinics.
Disclosures: The study authors reported no relevant disclosures. The National Natural Science Foundation of China funded the study. The Osteoarthritis Initiative is a partnership between the National Institutes of Health and Merck, Novartis, GlaxoSmithKline, and Pfizer.
Source: Lei G et al. ACR 2017 Abstract 1788.
Virtual reality enters the rheumatology realm
SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.
Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.
Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.
“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.
“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).
In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”
In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.
Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).
Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.
He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.
But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.
He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.
As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.
Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.
The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.
“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”
Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.
SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.
Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.
Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.
“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.
“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).
In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”
In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.
Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).
Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.
He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.
But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.
He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.
As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.
Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.
The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.
“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”
Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.
SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.
Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.
Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.
“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.
“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).
In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”
In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.
Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).
Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.
He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.
But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.
He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.
As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.
Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.
The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.
“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”
Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.
REPORTING FROM ACR 2017