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Neuroimaging may often be unneeded in ED seizure treatment
Neuroimaging may be appropriate only for specific types of patients with recurrent seizures who present at emergency departments because the scans are otherwise unlikely to prompt acute changes in treatment, a new multicenter study suggests.
“Going forward, our results should help ED providers determine which patients are more likely to derive benefit from neuroimaging and which patients are not likely to benefit,” lead author Martin Salinsky, MD, of Oregon Health & Science University, Portland, said in an interview. “They can be more selective in ordering scans and reduce the total number obtained.”
As the study authors noted in their report, published July 18 in Epilepsia, “head CT is generally considered a benign procedure. However, overuse is problematic.”
The scans are costly and expose patients to radiation equivalent to 10 chest x-rays, the authors wrote. Scans can complicate care by clogging ED work flow and producing false positives, and patients often seize while undergoing scans, creating even more complications, they added.
“There is very little information in the medical literature that would help guide ED providers in their decision of whether to obtain neuroimaging on a patient who presents with a recurrent seizure,” Dr. Salinsky said. “Without this information, the tendency is to be cautious and obtain scans in more patients.”
For the study, the researchers tracked 822 consecutive ED visits for nonindex – recurrent – epileptic seizures at Oregon Health & Science University and VA Portland Health Care medical centers. (Nonindex seizures accounted for 78% of the total seizures that prompted ED care.)
The study subjects were adults treated for seizure as the main complaint. Patients who had a history of seizures but hadn’t had one for at least 5 years were excluded.
Of the total nonindex seizures, 46% of those resulted in neuroimaging.
“The overall yield of neuroimaging in this patient group was 2%-3%,” Dr. Salinsky said, referring to the percentage of patients whose scans resulted in an acute change in management.
False positives due to imaging artifacts were subsequently discovered in 3 of the 11 patients whose neuroimaging prompted an acute change in management. When the false positives were removed, the yield of acute management changes prompted by neuroimaging decreased to 2.1% overall.
“Three clinical factors – acute head trauma, prolonged alteration of consciousness, and focal neurological examination [at presentation] – were associated with an increased yield of imaging,” he said. “Absent all three factors, the yield in our patients was zero.”
At the two medical centers, the percentages of patients with acute head trauma were 10% and 15%. Prolonged alteration of consciousness occurred in 6% at both centers, and focal neurological examination at presentation was observed in 12% and 14%.
A fourth factor, presentation with status epilepticus/acute repetitive seizures, “bordered on statistical significance and might have reached significance in a larger series,” the authors wrote.
As they put it, “these results support a more conservative use of ED neuroimaging for nonindex seizures, based on clinical factors at the time of presentation. ... without specific indications, ED neuroimaging for nonindex seizures is unlikely to result in an acute change in care.”
The study authors estimated that hundreds of millions of dollars could be saved annually in the United States if neuroimaging in these ED patients could be cut in half.
No study funding was reported, and the authors reported no relevant disclosures.
SOURCE: Salinsky M et al. Epilepsia. 2018 July 18. doi: 10.1111/epi.14518
Neuroimaging may be appropriate only for specific types of patients with recurrent seizures who present at emergency departments because the scans are otherwise unlikely to prompt acute changes in treatment, a new multicenter study suggests.
“Going forward, our results should help ED providers determine which patients are more likely to derive benefit from neuroimaging and which patients are not likely to benefit,” lead author Martin Salinsky, MD, of Oregon Health & Science University, Portland, said in an interview. “They can be more selective in ordering scans and reduce the total number obtained.”
As the study authors noted in their report, published July 18 in Epilepsia, “head CT is generally considered a benign procedure. However, overuse is problematic.”
The scans are costly and expose patients to radiation equivalent to 10 chest x-rays, the authors wrote. Scans can complicate care by clogging ED work flow and producing false positives, and patients often seize while undergoing scans, creating even more complications, they added.
“There is very little information in the medical literature that would help guide ED providers in their decision of whether to obtain neuroimaging on a patient who presents with a recurrent seizure,” Dr. Salinsky said. “Without this information, the tendency is to be cautious and obtain scans in more patients.”
For the study, the researchers tracked 822 consecutive ED visits for nonindex – recurrent – epileptic seizures at Oregon Health & Science University and VA Portland Health Care medical centers. (Nonindex seizures accounted for 78% of the total seizures that prompted ED care.)
The study subjects were adults treated for seizure as the main complaint. Patients who had a history of seizures but hadn’t had one for at least 5 years were excluded.
Of the total nonindex seizures, 46% of those resulted in neuroimaging.
“The overall yield of neuroimaging in this patient group was 2%-3%,” Dr. Salinsky said, referring to the percentage of patients whose scans resulted in an acute change in management.
False positives due to imaging artifacts were subsequently discovered in 3 of the 11 patients whose neuroimaging prompted an acute change in management. When the false positives were removed, the yield of acute management changes prompted by neuroimaging decreased to 2.1% overall.
“Three clinical factors – acute head trauma, prolonged alteration of consciousness, and focal neurological examination [at presentation] – were associated with an increased yield of imaging,” he said. “Absent all three factors, the yield in our patients was zero.”
At the two medical centers, the percentages of patients with acute head trauma were 10% and 15%. Prolonged alteration of consciousness occurred in 6% at both centers, and focal neurological examination at presentation was observed in 12% and 14%.
A fourth factor, presentation with status epilepticus/acute repetitive seizures, “bordered on statistical significance and might have reached significance in a larger series,” the authors wrote.
As they put it, “these results support a more conservative use of ED neuroimaging for nonindex seizures, based on clinical factors at the time of presentation. ... without specific indications, ED neuroimaging for nonindex seizures is unlikely to result in an acute change in care.”
The study authors estimated that hundreds of millions of dollars could be saved annually in the United States if neuroimaging in these ED patients could be cut in half.
No study funding was reported, and the authors reported no relevant disclosures.
SOURCE: Salinsky M et al. Epilepsia. 2018 July 18. doi: 10.1111/epi.14518
Neuroimaging may be appropriate only for specific types of patients with recurrent seizures who present at emergency departments because the scans are otherwise unlikely to prompt acute changes in treatment, a new multicenter study suggests.
“Going forward, our results should help ED providers determine which patients are more likely to derive benefit from neuroimaging and which patients are not likely to benefit,” lead author Martin Salinsky, MD, of Oregon Health & Science University, Portland, said in an interview. “They can be more selective in ordering scans and reduce the total number obtained.”
As the study authors noted in their report, published July 18 in Epilepsia, “head CT is generally considered a benign procedure. However, overuse is problematic.”
The scans are costly and expose patients to radiation equivalent to 10 chest x-rays, the authors wrote. Scans can complicate care by clogging ED work flow and producing false positives, and patients often seize while undergoing scans, creating even more complications, they added.
“There is very little information in the medical literature that would help guide ED providers in their decision of whether to obtain neuroimaging on a patient who presents with a recurrent seizure,” Dr. Salinsky said. “Without this information, the tendency is to be cautious and obtain scans in more patients.”
For the study, the researchers tracked 822 consecutive ED visits for nonindex – recurrent – epileptic seizures at Oregon Health & Science University and VA Portland Health Care medical centers. (Nonindex seizures accounted for 78% of the total seizures that prompted ED care.)
The study subjects were adults treated for seizure as the main complaint. Patients who had a history of seizures but hadn’t had one for at least 5 years were excluded.
Of the total nonindex seizures, 46% of those resulted in neuroimaging.
“The overall yield of neuroimaging in this patient group was 2%-3%,” Dr. Salinsky said, referring to the percentage of patients whose scans resulted in an acute change in management.
False positives due to imaging artifacts were subsequently discovered in 3 of the 11 patients whose neuroimaging prompted an acute change in management. When the false positives were removed, the yield of acute management changes prompted by neuroimaging decreased to 2.1% overall.
“Three clinical factors – acute head trauma, prolonged alteration of consciousness, and focal neurological examination [at presentation] – were associated with an increased yield of imaging,” he said. “Absent all three factors, the yield in our patients was zero.”
At the two medical centers, the percentages of patients with acute head trauma were 10% and 15%. Prolonged alteration of consciousness occurred in 6% at both centers, and focal neurological examination at presentation was observed in 12% and 14%.
A fourth factor, presentation with status epilepticus/acute repetitive seizures, “bordered on statistical significance and might have reached significance in a larger series,” the authors wrote.
As they put it, “these results support a more conservative use of ED neuroimaging for nonindex seizures, based on clinical factors at the time of presentation. ... without specific indications, ED neuroimaging for nonindex seizures is unlikely to result in an acute change in care.”
The study authors estimated that hundreds of millions of dollars could be saved annually in the United States if neuroimaging in these ED patients could be cut in half.
No study funding was reported, and the authors reported no relevant disclosures.
SOURCE: Salinsky M et al. Epilepsia. 2018 July 18. doi: 10.1111/epi.14518
FROM EPILEPSIA
Key clinical point: In emergency departments, patients with seizure disorders and nonindex seizures may need neuroimaging only if they have acute head trauma, prolonged alteration of consciousness, or focal neurological examination at presentation.
Major finding: Absent the three factors above, neuroimaging did not prompt any acute changes in management.
Study details: Retrospective examination of 822 consecutive ED visits for nonindex seizures in patients with seizure disorders at two medical centers.
Disclosures: No study funding was reported, and the study authors reported no relevant disclosures.
Source: Salinsky M et al. Epilepsia. 2018 Jul 18. doi: 10.1111/epi.14518.
Special care advised for HIV-infected patients with diabetes
ORLANDO – Research suggests that HIV-positive people who take the latest generations of AIDS medications are living almost as long as everyone else. But they still face special medical challenges, and an endocrinologist urged colleagues to adjust their approaches to diabetes in these patients.
said Todd T. Brown, MD, PhD, of Johns Hopkins Medicine, Baltimore, in a presentation at the annual scientific sessions of the American Diabetes Association.
It’s not just a matter of subbing in an alternate drug here or there. When it comes to diabetes, patients with HIV require significant adjustments to diagnosis and treatment, Dr. Brown said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In terms of diagnosis, treatment guidelines approved by the Infectious Diseases Society of America and ADA recommend that all HIV-positive patients be tested for diabetes before they begin taking antiretroviral therapy. Then, the guidelines suggest, they should be tested 4-6 weeks after initiation of therapy, and every 6-12 months going forward.
“It’s a bit of overkill to go every 6 months,” said Dr. Brown, who prefers an annual testing approach. He added that research has suggested that the 2-hour postload glucose test is more sensitive than the fasting glucose test in some HIV-positive populations. However, he believes that it’s generally fine to give a fasting glucose test before initiation of therapy – and on an annual basis afterward – rather than the more cumbersome postload test.
Still, he said, the postload test may be appropriate in a patient with impaired glucose tolerance “if you really want to make the diagnosis, and especially if you’ll change your treatment based on it.”
Ongoing treatment of HIV-positive patients also presents unique challenges, he said. For one, antiretroviral therapy seems to affect glucose metabolism and body fat, he said, and findings from a 2016 study suggest HIV-positive people who begin antiretroviral therapy face a higher risk of developing diabetes after weight gain (J Acquir Immune Defic Syndr. 2016 Oct 1;73[2]:228-36).
One option is to switch patients to integrase inhibitors, but findings from a 2017 study suggested that this may also lead to more weight gain, Dr. Brown said.
“This has been an evolving story,” he said. “The clinical consequences of this are unclear. This is a topic that’s being hotly investigated now in the HIV health world” (JAIDS. 2017 Dec 15;76[5]:527-31).
As for other diabetes management issues, Dr. Brown noted that hemoglobin A1c tests appear to underestimate glycemia in HIV-infected patients. He suggested that goal HbA1c levels should be lower in diabetic patients with HIV, especially those with CD4+ counts under 500 cells /mm3 and/or mean cell volume over 100 fL.
Research suggests that lifestyle changes seem to work well in HIV-positive patients, he said, and metformin is the ideal first-line drug treatment just as in the HIV-negative population. “It’s a good drug. We all love it,” he said. “It may improve lipohypertrophy and coronary plaque.”
He added that proteinuria and neuropathy are more common in HIV-positive patients with diabetes. He said levels of neuropathy and nephropathy could be related to AIDS drugs.
On the medication front, Dr. Brown cautioned about certain drugs in HIV-positive patients: The HIV drug dolutegravir increases metformin concentrations by about 80%, he said, and there are concerns about bone and cardiac health in HIV-positive patients who take the diabetes medications known as thiazolidinediones (glitazones).
He added that there are sparse data about the use of several types of diabetes drugs – DPP IV inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors – in HIV-positive patients.
Dr. Brown discloses consulting for Gilead Sciences, ViiV, BMS, Merck, Theratechnologies, and EMD Serono.
ORLANDO – Research suggests that HIV-positive people who take the latest generations of AIDS medications are living almost as long as everyone else. But they still face special medical challenges, and an endocrinologist urged colleagues to adjust their approaches to diabetes in these patients.
said Todd T. Brown, MD, PhD, of Johns Hopkins Medicine, Baltimore, in a presentation at the annual scientific sessions of the American Diabetes Association.
It’s not just a matter of subbing in an alternate drug here or there. When it comes to diabetes, patients with HIV require significant adjustments to diagnosis and treatment, Dr. Brown said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In terms of diagnosis, treatment guidelines approved by the Infectious Diseases Society of America and ADA recommend that all HIV-positive patients be tested for diabetes before they begin taking antiretroviral therapy. Then, the guidelines suggest, they should be tested 4-6 weeks after initiation of therapy, and every 6-12 months going forward.
“It’s a bit of overkill to go every 6 months,” said Dr. Brown, who prefers an annual testing approach. He added that research has suggested that the 2-hour postload glucose test is more sensitive than the fasting glucose test in some HIV-positive populations. However, he believes that it’s generally fine to give a fasting glucose test before initiation of therapy – and on an annual basis afterward – rather than the more cumbersome postload test.
Still, he said, the postload test may be appropriate in a patient with impaired glucose tolerance “if you really want to make the diagnosis, and especially if you’ll change your treatment based on it.”
Ongoing treatment of HIV-positive patients also presents unique challenges, he said. For one, antiretroviral therapy seems to affect glucose metabolism and body fat, he said, and findings from a 2016 study suggest HIV-positive people who begin antiretroviral therapy face a higher risk of developing diabetes after weight gain (J Acquir Immune Defic Syndr. 2016 Oct 1;73[2]:228-36).
One option is to switch patients to integrase inhibitors, but findings from a 2017 study suggested that this may also lead to more weight gain, Dr. Brown said.
“This has been an evolving story,” he said. “The clinical consequences of this are unclear. This is a topic that’s being hotly investigated now in the HIV health world” (JAIDS. 2017 Dec 15;76[5]:527-31).
As for other diabetes management issues, Dr. Brown noted that hemoglobin A1c tests appear to underestimate glycemia in HIV-infected patients. He suggested that goal HbA1c levels should be lower in diabetic patients with HIV, especially those with CD4+ counts under 500 cells /mm3 and/or mean cell volume over 100 fL.
Research suggests that lifestyle changes seem to work well in HIV-positive patients, he said, and metformin is the ideal first-line drug treatment just as in the HIV-negative population. “It’s a good drug. We all love it,” he said. “It may improve lipohypertrophy and coronary plaque.”
He added that proteinuria and neuropathy are more common in HIV-positive patients with diabetes. He said levels of neuropathy and nephropathy could be related to AIDS drugs.
On the medication front, Dr. Brown cautioned about certain drugs in HIV-positive patients: The HIV drug dolutegravir increases metformin concentrations by about 80%, he said, and there are concerns about bone and cardiac health in HIV-positive patients who take the diabetes medications known as thiazolidinediones (glitazones).
He added that there are sparse data about the use of several types of diabetes drugs – DPP IV inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors – in HIV-positive patients.
Dr. Brown discloses consulting for Gilead Sciences, ViiV, BMS, Merck, Theratechnologies, and EMD Serono.
ORLANDO – Research suggests that HIV-positive people who take the latest generations of AIDS medications are living almost as long as everyone else. But they still face special medical challenges, and an endocrinologist urged colleagues to adjust their approaches to diabetes in these patients.
said Todd T. Brown, MD, PhD, of Johns Hopkins Medicine, Baltimore, in a presentation at the annual scientific sessions of the American Diabetes Association.
It’s not just a matter of subbing in an alternate drug here or there. When it comes to diabetes, patients with HIV require significant adjustments to diagnosis and treatment, Dr. Brown said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In terms of diagnosis, treatment guidelines approved by the Infectious Diseases Society of America and ADA recommend that all HIV-positive patients be tested for diabetes before they begin taking antiretroviral therapy. Then, the guidelines suggest, they should be tested 4-6 weeks after initiation of therapy, and every 6-12 months going forward.
“It’s a bit of overkill to go every 6 months,” said Dr. Brown, who prefers an annual testing approach. He added that research has suggested that the 2-hour postload glucose test is more sensitive than the fasting glucose test in some HIV-positive populations. However, he believes that it’s generally fine to give a fasting glucose test before initiation of therapy – and on an annual basis afterward – rather than the more cumbersome postload test.
Still, he said, the postload test may be appropriate in a patient with impaired glucose tolerance “if you really want to make the diagnosis, and especially if you’ll change your treatment based on it.”
Ongoing treatment of HIV-positive patients also presents unique challenges, he said. For one, antiretroviral therapy seems to affect glucose metabolism and body fat, he said, and findings from a 2016 study suggest HIV-positive people who begin antiretroviral therapy face a higher risk of developing diabetes after weight gain (J Acquir Immune Defic Syndr. 2016 Oct 1;73[2]:228-36).
One option is to switch patients to integrase inhibitors, but findings from a 2017 study suggested that this may also lead to more weight gain, Dr. Brown said.
“This has been an evolving story,” he said. “The clinical consequences of this are unclear. This is a topic that’s being hotly investigated now in the HIV health world” (JAIDS. 2017 Dec 15;76[5]:527-31).
As for other diabetes management issues, Dr. Brown noted that hemoglobin A1c tests appear to underestimate glycemia in HIV-infected patients. He suggested that goal HbA1c levels should be lower in diabetic patients with HIV, especially those with CD4+ counts under 500 cells /mm3 and/or mean cell volume over 100 fL.
Research suggests that lifestyle changes seem to work well in HIV-positive patients, he said, and metformin is the ideal first-line drug treatment just as in the HIV-negative population. “It’s a good drug. We all love it,” he said. “It may improve lipohypertrophy and coronary plaque.”
He added that proteinuria and neuropathy are more common in HIV-positive patients with diabetes. He said levels of neuropathy and nephropathy could be related to AIDS drugs.
On the medication front, Dr. Brown cautioned about certain drugs in HIV-positive patients: The HIV drug dolutegravir increases metformin concentrations by about 80%, he said, and there are concerns about bone and cardiac health in HIV-positive patients who take the diabetes medications known as thiazolidinediones (glitazones).
He added that there are sparse data about the use of several types of diabetes drugs – DPP IV inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors – in HIV-positive patients.
Dr. Brown discloses consulting for Gilead Sciences, ViiV, BMS, Merck, Theratechnologies, and EMD Serono.
EXPERT ANALYSIS FROM ADA 2018
Closed-loop insulin control for T2DM is feasible in hospital setting
ORLANDO – (T2DM).
The findings, released at the annual scientific sessions of the American Diabetes Association and via simultaneous publication in The New England Journal of Medicine, don’t examine cost or clinical outcomes. However, “our results suggest this new technology might be another approach to manage in-patient hypoglycemia in a safe and effective way, lead author Lia Bally, MD, PhD, of the division of endocrinology, diabetes, and clinical nutrition, Bern (Switzerland ) University Hospital, said in an interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
For the open-label trial, the researchers recruited 136 adults with T2DM under noncritical care at two hospitals (one in the England and the other in Switzerland). Some patients had undergone surgery, Dr. Bally said, and some others were being treated for systemic infections. Comorbidities were significantly more severe in the closed-loop group, and 43% had sepsis.
All of the subjects required subcutaneous insulin therapy.
From 2016 to 2017, patients were randomly assigned to receive normal subcutaneous insulin therapy (n = 70) or closed-loop insulin delivery (n = 66).
It took about 15 minutes to perform the procedure to implement the closed-loop insulin delivery system, Dr. Bally said. It featured a subcutaneous cannula inserted into the abdomen, a continuous glucose monitor (a device also used in the control group), and a trial insulin pump.
This was not a hybrid system, and it did not include prandial insulin boluses or input of the timing and carbohydrate content of meals. One reason behind the choice to adopt a fully automated system was to relieve the burden on both health care professionals and patients, coauthor Hood Thabit, PhD, of Wellcome Trust–MRC Institute of Metabolic Science, the Manchester Academic Health Science Center, and University of Manchester, said in an interview.
For up to 15 days or until discharge, researchers tracked how much of the time sensor glucose measurements were in a target range of 100 mg/dL to 180 mg/dL.
In the closed-loop group, glucose measurements were in the target range 66 mg/dL ± 17% of the time compared to 42 mg/dL ± 17% in the control group, a difference of 24 mg/dL ± 3% (95% confidence interval, 19-30; P less than .001).
For the closed-loop group, the average glucose level was 154 mg/dL, and it was 188 mg/dL in the control group (P less than .001).
The researchers didn’t find a statistically significant difference between the groups in duration of hypoglycemia or amount of insulin delivered.
None of the patients suffered from severe hypoglycemia or clinically significant hyperglycemia with ketonemia.
There were 18 incidents of clinically significant hyperglycemia events (capillary glucose levels of more than 360 mg/dL) in the closed-loop group, compared with 41 such events in the control group. (P = .03)
Three patients in each group had adverse trial-related device effects.
Of 62 patients in the closed-loop group who completed the trial, 87% reported being pleased by their glucose levels, and all but one reported being happy to have their levels monitored automatically. All 62 patients said they’d recommend the system to others.
Going forward, the researchers hope to launch a multicenter trial that will examine clinical outcomes such as postoperative complications, infections, mortality, and glucose control after hospital discharge, according to Dr. Bally.
The study was supported by Diabetes UK, the Swiss National Science Foundation, the European Foundation for the Study of Diabetes, the JDRF, the National Institute for Health Research Cambridge Biomedical Research Center, and a Wellcome Strategic Award. Abbott Diabetes Care supplied equipment and guidance regarding connectivity, and representatives reviewed the manuscript before submission.
Dr. Bally reported funding from the University Hospital Bern, University of Bern and the Swiss Diabetes Foundation. Dr. Thabit reported no disclosures. Other authors report no disclosures or various disclosures.
SOURCE: Bally L et al. ADA 2018 Abstract 350-OR. Published simultaneously in The New England Journal of Medicine. June 25, 2018
ORLANDO – (T2DM).
The findings, released at the annual scientific sessions of the American Diabetes Association and via simultaneous publication in The New England Journal of Medicine, don’t examine cost or clinical outcomes. However, “our results suggest this new technology might be another approach to manage in-patient hypoglycemia in a safe and effective way, lead author Lia Bally, MD, PhD, of the division of endocrinology, diabetes, and clinical nutrition, Bern (Switzerland ) University Hospital, said in an interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
For the open-label trial, the researchers recruited 136 adults with T2DM under noncritical care at two hospitals (one in the England and the other in Switzerland). Some patients had undergone surgery, Dr. Bally said, and some others were being treated for systemic infections. Comorbidities were significantly more severe in the closed-loop group, and 43% had sepsis.
All of the subjects required subcutaneous insulin therapy.
From 2016 to 2017, patients were randomly assigned to receive normal subcutaneous insulin therapy (n = 70) or closed-loop insulin delivery (n = 66).
It took about 15 minutes to perform the procedure to implement the closed-loop insulin delivery system, Dr. Bally said. It featured a subcutaneous cannula inserted into the abdomen, a continuous glucose monitor (a device also used in the control group), and a trial insulin pump.
This was not a hybrid system, and it did not include prandial insulin boluses or input of the timing and carbohydrate content of meals. One reason behind the choice to adopt a fully automated system was to relieve the burden on both health care professionals and patients, coauthor Hood Thabit, PhD, of Wellcome Trust–MRC Institute of Metabolic Science, the Manchester Academic Health Science Center, and University of Manchester, said in an interview.
For up to 15 days or until discharge, researchers tracked how much of the time sensor glucose measurements were in a target range of 100 mg/dL to 180 mg/dL.
In the closed-loop group, glucose measurements were in the target range 66 mg/dL ± 17% of the time compared to 42 mg/dL ± 17% in the control group, a difference of 24 mg/dL ± 3% (95% confidence interval, 19-30; P less than .001).
For the closed-loop group, the average glucose level was 154 mg/dL, and it was 188 mg/dL in the control group (P less than .001).
The researchers didn’t find a statistically significant difference between the groups in duration of hypoglycemia or amount of insulin delivered.
None of the patients suffered from severe hypoglycemia or clinically significant hyperglycemia with ketonemia.
There were 18 incidents of clinically significant hyperglycemia events (capillary glucose levels of more than 360 mg/dL) in the closed-loop group, compared with 41 such events in the control group. (P = .03)
Three patients in each group had adverse trial-related device effects.
Of 62 patients in the closed-loop group who completed the trial, 87% reported being pleased by their glucose levels, and all but one reported being happy to have their levels monitored automatically. All 62 patients said they’d recommend the system to others.
Going forward, the researchers hope to launch a multicenter trial that will examine clinical outcomes such as postoperative complications, infections, mortality, and glucose control after hospital discharge, according to Dr. Bally.
The study was supported by Diabetes UK, the Swiss National Science Foundation, the European Foundation for the Study of Diabetes, the JDRF, the National Institute for Health Research Cambridge Biomedical Research Center, and a Wellcome Strategic Award. Abbott Diabetes Care supplied equipment and guidance regarding connectivity, and representatives reviewed the manuscript before submission.
Dr. Bally reported funding from the University Hospital Bern, University of Bern and the Swiss Diabetes Foundation. Dr. Thabit reported no disclosures. Other authors report no disclosures or various disclosures.
SOURCE: Bally L et al. ADA 2018 Abstract 350-OR. Published simultaneously in The New England Journal of Medicine. June 25, 2018
ORLANDO – (T2DM).
The findings, released at the annual scientific sessions of the American Diabetes Association and via simultaneous publication in The New England Journal of Medicine, don’t examine cost or clinical outcomes. However, “our results suggest this new technology might be another approach to manage in-patient hypoglycemia in a safe and effective way, lead author Lia Bally, MD, PhD, of the division of endocrinology, diabetes, and clinical nutrition, Bern (Switzerland ) University Hospital, said in an interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
For the open-label trial, the researchers recruited 136 adults with T2DM under noncritical care at two hospitals (one in the England and the other in Switzerland). Some patients had undergone surgery, Dr. Bally said, and some others were being treated for systemic infections. Comorbidities were significantly more severe in the closed-loop group, and 43% had sepsis.
All of the subjects required subcutaneous insulin therapy.
From 2016 to 2017, patients were randomly assigned to receive normal subcutaneous insulin therapy (n = 70) or closed-loop insulin delivery (n = 66).
It took about 15 minutes to perform the procedure to implement the closed-loop insulin delivery system, Dr. Bally said. It featured a subcutaneous cannula inserted into the abdomen, a continuous glucose monitor (a device also used in the control group), and a trial insulin pump.
This was not a hybrid system, and it did not include prandial insulin boluses or input of the timing and carbohydrate content of meals. One reason behind the choice to adopt a fully automated system was to relieve the burden on both health care professionals and patients, coauthor Hood Thabit, PhD, of Wellcome Trust–MRC Institute of Metabolic Science, the Manchester Academic Health Science Center, and University of Manchester, said in an interview.
For up to 15 days or until discharge, researchers tracked how much of the time sensor glucose measurements were in a target range of 100 mg/dL to 180 mg/dL.
In the closed-loop group, glucose measurements were in the target range 66 mg/dL ± 17% of the time compared to 42 mg/dL ± 17% in the control group, a difference of 24 mg/dL ± 3% (95% confidence interval, 19-30; P less than .001).
For the closed-loop group, the average glucose level was 154 mg/dL, and it was 188 mg/dL in the control group (P less than .001).
The researchers didn’t find a statistically significant difference between the groups in duration of hypoglycemia or amount of insulin delivered.
None of the patients suffered from severe hypoglycemia or clinically significant hyperglycemia with ketonemia.
There were 18 incidents of clinically significant hyperglycemia events (capillary glucose levels of more than 360 mg/dL) in the closed-loop group, compared with 41 such events in the control group. (P = .03)
Three patients in each group had adverse trial-related device effects.
Of 62 patients in the closed-loop group who completed the trial, 87% reported being pleased by their glucose levels, and all but one reported being happy to have their levels monitored automatically. All 62 patients said they’d recommend the system to others.
Going forward, the researchers hope to launch a multicenter trial that will examine clinical outcomes such as postoperative complications, infections, mortality, and glucose control after hospital discharge, according to Dr. Bally.
The study was supported by Diabetes UK, the Swiss National Science Foundation, the European Foundation for the Study of Diabetes, the JDRF, the National Institute for Health Research Cambridge Biomedical Research Center, and a Wellcome Strategic Award. Abbott Diabetes Care supplied equipment and guidance regarding connectivity, and representatives reviewed the manuscript before submission.
Dr. Bally reported funding from the University Hospital Bern, University of Bern and the Swiss Diabetes Foundation. Dr. Thabit reported no disclosures. Other authors report no disclosures or various disclosures.
SOURCE: Bally L et al. ADA 2018 Abstract 350-OR. Published simultaneously in The New England Journal of Medicine. June 25, 2018
REPORTING FROM ADA 2018
Key clinical point: Use of an automated closed-loop insulin delivery system may be feasible in the noncritical hospital setting.
Major finding: In the closed-loop group, glucose measurements were in the target range 66 mg/dL ± 17% of the time compared with 42 mg/dL ± 17% in the control group, a difference of 24 mg/dL ± 3% (95% CI, 19-30; P less than .001).
Study details: Randomized, open-label, two-center trial of 136 inpatients with type 2 diabetes mellitus assigned to either standard subcutaneous insulin therapy or closed-loop insulin delivery for 15 days or until discharge.
Disclosures: The study was supported by Diabetes UK, the Swiss National Science Foundation, the European Foundation for the Study of Diabetes, the JDRF, the National Institute for Health Research Cambridge Biomedical Research Center, and a Wellcome Strategic Award. Abbott Diabetes Care supplied equipment and guidance regarding connectivity, and representatives reviewed the manuscript before submission. The researchers reported no disclosures or various disclosures.
Source: Bally L et al. ADA 2018 Abstract 350-OR.
Meet the rare diabetes diagnosis that thrills patients
ORLANDO – Liana K. Billings, MD, an endocrinologist at the University of Chicago and the NorthShore University HealthSystem in Skokie, Ill., loves the thrill of letting patients know they have a rare kind of diabetes. “Once you do this once, you don’t want to stop,” she told colleagues in a presentation at the annual scientific sessions of the American Diabetes Association.
Yes, it’s true: There’s a diabetes diagnosis that spawns good feelings like delight and relief. The cause for celebration is a condition known as monogenetic diabetes, also known as maturity-onset diabetes of the young (MODY) if it develops after the neonatal period.
“The reason that getting a diagnosis of MODY can be a ‘good’ diagnosis is because the three most common forms of MODY have gene-specific treatments that typically improve patients’ glycemic control and are less onerous than the treatments patients were previously receiving when they were thought to have type 1 or type 2 diabetes,” explained Miriam S. Udler, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, in an interview.
Dr. Udler and Dr. Billings spoke to colleagues about monogenetic diabetes in their presentation at the ADA meeting.
Research has suggested that 1%-4% of people with diabetes have the monogenetic form, in which the condition is caused by changes in a single gene. A 2017 British study of 1,407 patients with diabetes reported that “the minimum prevalence of monogenic diabetes is 3.6% of patients diagnosed at age 30 years or younger.”
The study, which tested a screening regimen, also turned up 17 new diagnoses of monogenetic diabetes among the 1,407 patients, doubling the total. The findings reflect an apparent fact about monogenetic diabetes: Physicians often don’t look for it, even though a diagnosis can be a godsend – especially for those who were previously diagnosed with type 1 or type 2 and placed on treatment regimens that are unnecessary at best and harmful at worst. (Diabetes Care. 2017 Aug;40[8]: 1017-25)
Patients with the MODY variant in the GCK gene, for example, “can generally stop all medications because they are not at risk for clinically significant complications of diabetes,” Dr. Udler said. “Patients with HNF1A and HNF4A variants can often be switched from insulin injections to ... a sulfonylurea, which is easier to take than insulin injections, and patients generally have better glycemic control after switching to pills.”
Unfortunately for doctors and patients, it can be complicated and costly to test for monogenetic diabetes. But screening tools are available to help physicians make choices about whether to launch testing in the first place, according to Dr. Udler and Dr. Billings.
There are two forms of monogenetic diabetes – neonatal diabetes, which is diagnosed by age 6-9 months, and MODY, which is typically diagnosed in those aged between 10 and 25 years, noted Dr. Billings.
Reasons to suspect MODY include early onset of diabetes (under 35 years), a family history of diabetes, a lack of obesity, and negative islet-cell antibodies, she said.
Obese patients may also have the condition: A 2017 American study of 488 overweight and obese children and adolescents diagnosed with type 2 diabetes found that 4.5% actually had monogenetic diabetes. (Genet Med. 2018 Jun;20[6]:583-90).
Once a physician suspects MODY, physicians may consult the University of Exeter’s risk calculator. It provides guidance about whether a test is a good idea. Dr. Billings cautioned, however, that the value of a calculator’s estimate of risk is not all-encompassing. “You should never use the calculator by itself as a reason to not pursue your intuition,” she said.
Dr. Udler noted that the University of Exeter calculator has important limitations, such as its reliance on specific genes, its lack of consideration of family history outside of parents, and its reliance on the experiences of white European patients.
As for tests, the University of Chicago and the University of Exeter both offer free genetic testing for neonatal diabetes, Dr. Billings said in her presentation.
Monogenetic diabetes tests in older children and adults are not free. However, Dr. Udler said the tests are often covered by insurance companies whether done for one or more genes.
At least one company offers a direct-to-consumer monogenetic diabetes test, according to Dr. Udler, but she recommended against it, especially in light of a curious online notice that says the test isn’t intended to be diagnostic. “I’m not sure what this would be useful for then,” she said.
For her part, Dr. Billings cautioned that test results may be inconclusive, and tests may offer different answers. She also recommended referring patients to genetic counseling.
Dr. Udler reported a board member/advisory panel relationship with Encompass Bioscience. Dr. Billings reported relationships with Novo Nordisk, Sanofi, and Dexcom.
ORLANDO – Liana K. Billings, MD, an endocrinologist at the University of Chicago and the NorthShore University HealthSystem in Skokie, Ill., loves the thrill of letting patients know they have a rare kind of diabetes. “Once you do this once, you don’t want to stop,” she told colleagues in a presentation at the annual scientific sessions of the American Diabetes Association.
Yes, it’s true: There’s a diabetes diagnosis that spawns good feelings like delight and relief. The cause for celebration is a condition known as monogenetic diabetes, also known as maturity-onset diabetes of the young (MODY) if it develops after the neonatal period.
“The reason that getting a diagnosis of MODY can be a ‘good’ diagnosis is because the three most common forms of MODY have gene-specific treatments that typically improve patients’ glycemic control and are less onerous than the treatments patients were previously receiving when they were thought to have type 1 or type 2 diabetes,” explained Miriam S. Udler, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, in an interview.
Dr. Udler and Dr. Billings spoke to colleagues about monogenetic diabetes in their presentation at the ADA meeting.
Research has suggested that 1%-4% of people with diabetes have the monogenetic form, in which the condition is caused by changes in a single gene. A 2017 British study of 1,407 patients with diabetes reported that “the minimum prevalence of monogenic diabetes is 3.6% of patients diagnosed at age 30 years or younger.”
The study, which tested a screening regimen, also turned up 17 new diagnoses of monogenetic diabetes among the 1,407 patients, doubling the total. The findings reflect an apparent fact about monogenetic diabetes: Physicians often don’t look for it, even though a diagnosis can be a godsend – especially for those who were previously diagnosed with type 1 or type 2 and placed on treatment regimens that are unnecessary at best and harmful at worst. (Diabetes Care. 2017 Aug;40[8]: 1017-25)
Patients with the MODY variant in the GCK gene, for example, “can generally stop all medications because they are not at risk for clinically significant complications of diabetes,” Dr. Udler said. “Patients with HNF1A and HNF4A variants can often be switched from insulin injections to ... a sulfonylurea, which is easier to take than insulin injections, and patients generally have better glycemic control after switching to pills.”
Unfortunately for doctors and patients, it can be complicated and costly to test for monogenetic diabetes. But screening tools are available to help physicians make choices about whether to launch testing in the first place, according to Dr. Udler and Dr. Billings.
There are two forms of monogenetic diabetes – neonatal diabetes, which is diagnosed by age 6-9 months, and MODY, which is typically diagnosed in those aged between 10 and 25 years, noted Dr. Billings.
Reasons to suspect MODY include early onset of diabetes (under 35 years), a family history of diabetes, a lack of obesity, and negative islet-cell antibodies, she said.
Obese patients may also have the condition: A 2017 American study of 488 overweight and obese children and adolescents diagnosed with type 2 diabetes found that 4.5% actually had monogenetic diabetes. (Genet Med. 2018 Jun;20[6]:583-90).
Once a physician suspects MODY, physicians may consult the University of Exeter’s risk calculator. It provides guidance about whether a test is a good idea. Dr. Billings cautioned, however, that the value of a calculator’s estimate of risk is not all-encompassing. “You should never use the calculator by itself as a reason to not pursue your intuition,” she said.
Dr. Udler noted that the University of Exeter calculator has important limitations, such as its reliance on specific genes, its lack of consideration of family history outside of parents, and its reliance on the experiences of white European patients.
As for tests, the University of Chicago and the University of Exeter both offer free genetic testing for neonatal diabetes, Dr. Billings said in her presentation.
Monogenetic diabetes tests in older children and adults are not free. However, Dr. Udler said the tests are often covered by insurance companies whether done for one or more genes.
At least one company offers a direct-to-consumer monogenetic diabetes test, according to Dr. Udler, but she recommended against it, especially in light of a curious online notice that says the test isn’t intended to be diagnostic. “I’m not sure what this would be useful for then,” she said.
For her part, Dr. Billings cautioned that test results may be inconclusive, and tests may offer different answers. She also recommended referring patients to genetic counseling.
Dr. Udler reported a board member/advisory panel relationship with Encompass Bioscience. Dr. Billings reported relationships with Novo Nordisk, Sanofi, and Dexcom.
ORLANDO – Liana K. Billings, MD, an endocrinologist at the University of Chicago and the NorthShore University HealthSystem in Skokie, Ill., loves the thrill of letting patients know they have a rare kind of diabetes. “Once you do this once, you don’t want to stop,” she told colleagues in a presentation at the annual scientific sessions of the American Diabetes Association.
Yes, it’s true: There’s a diabetes diagnosis that spawns good feelings like delight and relief. The cause for celebration is a condition known as monogenetic diabetes, also known as maturity-onset diabetes of the young (MODY) if it develops after the neonatal period.
“The reason that getting a diagnosis of MODY can be a ‘good’ diagnosis is because the three most common forms of MODY have gene-specific treatments that typically improve patients’ glycemic control and are less onerous than the treatments patients were previously receiving when they were thought to have type 1 or type 2 diabetes,” explained Miriam S. Udler, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, in an interview.
Dr. Udler and Dr. Billings spoke to colleagues about monogenetic diabetes in their presentation at the ADA meeting.
Research has suggested that 1%-4% of people with diabetes have the monogenetic form, in which the condition is caused by changes in a single gene. A 2017 British study of 1,407 patients with diabetes reported that “the minimum prevalence of monogenic diabetes is 3.6% of patients diagnosed at age 30 years or younger.”
The study, which tested a screening regimen, also turned up 17 new diagnoses of monogenetic diabetes among the 1,407 patients, doubling the total. The findings reflect an apparent fact about monogenetic diabetes: Physicians often don’t look for it, even though a diagnosis can be a godsend – especially for those who were previously diagnosed with type 1 or type 2 and placed on treatment regimens that are unnecessary at best and harmful at worst. (Diabetes Care. 2017 Aug;40[8]: 1017-25)
Patients with the MODY variant in the GCK gene, for example, “can generally stop all medications because they are not at risk for clinically significant complications of diabetes,” Dr. Udler said. “Patients with HNF1A and HNF4A variants can often be switched from insulin injections to ... a sulfonylurea, which is easier to take than insulin injections, and patients generally have better glycemic control after switching to pills.”
Unfortunately for doctors and patients, it can be complicated and costly to test for monogenetic diabetes. But screening tools are available to help physicians make choices about whether to launch testing in the first place, according to Dr. Udler and Dr. Billings.
There are two forms of monogenetic diabetes – neonatal diabetes, which is diagnosed by age 6-9 months, and MODY, which is typically diagnosed in those aged between 10 and 25 years, noted Dr. Billings.
Reasons to suspect MODY include early onset of diabetes (under 35 years), a family history of diabetes, a lack of obesity, and negative islet-cell antibodies, she said.
Obese patients may also have the condition: A 2017 American study of 488 overweight and obese children and adolescents diagnosed with type 2 diabetes found that 4.5% actually had monogenetic diabetes. (Genet Med. 2018 Jun;20[6]:583-90).
Once a physician suspects MODY, physicians may consult the University of Exeter’s risk calculator. It provides guidance about whether a test is a good idea. Dr. Billings cautioned, however, that the value of a calculator’s estimate of risk is not all-encompassing. “You should never use the calculator by itself as a reason to not pursue your intuition,” she said.
Dr. Udler noted that the University of Exeter calculator has important limitations, such as its reliance on specific genes, its lack of consideration of family history outside of parents, and its reliance on the experiences of white European patients.
As for tests, the University of Chicago and the University of Exeter both offer free genetic testing for neonatal diabetes, Dr. Billings said in her presentation.
Monogenetic diabetes tests in older children and adults are not free. However, Dr. Udler said the tests are often covered by insurance companies whether done for one or more genes.
At least one company offers a direct-to-consumer monogenetic diabetes test, according to Dr. Udler, but she recommended against it, especially in light of a curious online notice that says the test isn’t intended to be diagnostic. “I’m not sure what this would be useful for then,” she said.
For her part, Dr. Billings cautioned that test results may be inconclusive, and tests may offer different answers. She also recommended referring patients to genetic counseling.
Dr. Udler reported a board member/advisory panel relationship with Encompass Bioscience. Dr. Billings reported relationships with Novo Nordisk, Sanofi, and Dexcom.
EXPERT ANALYSIS FROM ADA 2018
Research supports cannabis in MS, but legal, clinical pictures are murky
The medical marijuana landscape is changing so fast that Colorado Neurological Institute neurologist Allen C. Bowling, MD, PhD, already needs to update a presentation he gave about cannabis in multiple sclerosis in late May.
Since then, both those facts became history over a span of 2 days.
First, on June 25, the FDA announced its approval of Epidiolex (cannabidiol) for the treatment of seizures in two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. It’s the first time the FDA has approved a drug with a purified ingredient – cannabidiol, a nonpsychoactive substance – that’s derived from marijuana.
Then, on June 26, voters in Oklahoma approved a ballot measure that allows the possession of marijuana for medical use; users must register with the state. Thirty states and the District of Columbia have made medical marijuana legal, according to the procon.org website, although the two newest ones (Oklahoma and West Virginia) are still developing procedures.
The laws vary widely. Some states don’t allow patients to smoke medical marijuana, and some don’t allow visitors to use out-of-state registry ID cards. And certain states limit the use of medical marijuana to specific conditions. Medical marijuana use by patients with MS is specifically allowed in many states, including Alaska, Arizona, Florida, Minnesota, and several others.
There’s another complexity: According to procon.org, 17 states have laws about the use of cannabidiol. In Georgia, for instance, the use of some cannabis oil is allowed for the treatment of MS and other conditions.
In the wake of the FDA ruling, Dr. Bowling spoke in an interview about cannabis, MS, and the questions that neurologists should be asking themselves.
Q: What are studies telling us about cannabis and MS?
A: There are lots of clinical studies – 19 randomized controlled trials. A consistent finding is that there’s benefit in terms of pain and people’s subjective sense of spasticity (Neurology. 2014 Apr 29;82(17):1556-63).
Q: During your CMSC presentation, you talked about how “fidelity” has been a problem in cannabis research. Could you elaborate on what you mean?
A: The products used in these studies are generally standardized, research-grade products that you can’t buy in any U.S. dispensary.
Cannabis is complex and contains more than 100 different potentially pharmacologically active molecules. You can’t conclude that if you see a product in clinical trials, you’ll then be able to walk into a dispensary for recreational or medical cannabis and get a product that produces the same effect.
Q: What have you seen in your own patient population in terms of cannabis use?
A: I find what’s been found with the studies: It helps with pain and people’s sense of muscle stiffness.
It’s especially helpful in people with pain and spasticity that breaks through in the late afternoon or at night when they’re trying to go to sleep. Just a little bit of cannabis can get them through those difficult times and improve their quality of life.
Q: What choices do patients make regarding whether to get high from the cannabis they use?
A: Some have absolutely zero interest in getting high, and they try to avoid the THC-containing products. Other like getting high in addition to getting help with pain and spasticity.
Q: Who should not use medical marijuana in the MS community?
A: Patients who don’t have symptoms that could respond.
I’m also very concerned about patients who are 25 years and younger because of the effects that cannabis can have on brain development out to age 25 and the higher risk of addiction in people who are younger.
Q: What do you think the future will hold on the cannabis front?
A: Now that it’s less of a taboo topic, there’s an ever-growing number of trials each year, including very high-quality studies.
Pharmaceutically produced, cannabis-based medicines will be a growing area. Epidiolex is a perfect example of that.
It’s important for physicians to know that the way cannabis-based medicine is produced by a pharmaceutical company is different in so many levels than the cannabis in states with recreational and medical marijuana.
Q: What are some ways that the pharmaceutical products are different?
A: The rigor of the production process, the standardization, the purity, the correct labeling and expiration dates. Plus, the lack of the use of pesticides and other contaminants. And they’re distributed by pharmacists.
Q: What should neurologists be thinking if they’re considering whether to recommend cannabis to their patients?
A: This is a very complex topic, and it’s not something that most of us have training in. You can’t sit down for 1 or 2 hours, get up to speed, and have your own well-informed opinion on it. You really need to put more time and effort.
Q: What are some issues that neurologists should consider?
A: You really need to find out what your state is doing about it and see how you feel about that.
How is your state administering medical and/or recreational marijuana? The administration of these programs is extremely different from state to state. Do these details satisfy you, and are you content having your patients interface with these programs?
Dr. Bowling reports no relevant disclosures.
The medical marijuana landscape is changing so fast that Colorado Neurological Institute neurologist Allen C. Bowling, MD, PhD, already needs to update a presentation he gave about cannabis in multiple sclerosis in late May.
Since then, both those facts became history over a span of 2 days.
First, on June 25, the FDA announced its approval of Epidiolex (cannabidiol) for the treatment of seizures in two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. It’s the first time the FDA has approved a drug with a purified ingredient – cannabidiol, a nonpsychoactive substance – that’s derived from marijuana.
Then, on June 26, voters in Oklahoma approved a ballot measure that allows the possession of marijuana for medical use; users must register with the state. Thirty states and the District of Columbia have made medical marijuana legal, according to the procon.org website, although the two newest ones (Oklahoma and West Virginia) are still developing procedures.
The laws vary widely. Some states don’t allow patients to smoke medical marijuana, and some don’t allow visitors to use out-of-state registry ID cards. And certain states limit the use of medical marijuana to specific conditions. Medical marijuana use by patients with MS is specifically allowed in many states, including Alaska, Arizona, Florida, Minnesota, and several others.
There’s another complexity: According to procon.org, 17 states have laws about the use of cannabidiol. In Georgia, for instance, the use of some cannabis oil is allowed for the treatment of MS and other conditions.
In the wake of the FDA ruling, Dr. Bowling spoke in an interview about cannabis, MS, and the questions that neurologists should be asking themselves.
Q: What are studies telling us about cannabis and MS?
A: There are lots of clinical studies – 19 randomized controlled trials. A consistent finding is that there’s benefit in terms of pain and people’s subjective sense of spasticity (Neurology. 2014 Apr 29;82(17):1556-63).
Q: During your CMSC presentation, you talked about how “fidelity” has been a problem in cannabis research. Could you elaborate on what you mean?
A: The products used in these studies are generally standardized, research-grade products that you can’t buy in any U.S. dispensary.
Cannabis is complex and contains more than 100 different potentially pharmacologically active molecules. You can’t conclude that if you see a product in clinical trials, you’ll then be able to walk into a dispensary for recreational or medical cannabis and get a product that produces the same effect.
Q: What have you seen in your own patient population in terms of cannabis use?
A: I find what’s been found with the studies: It helps with pain and people’s sense of muscle stiffness.
It’s especially helpful in people with pain and spasticity that breaks through in the late afternoon or at night when they’re trying to go to sleep. Just a little bit of cannabis can get them through those difficult times and improve their quality of life.
Q: What choices do patients make regarding whether to get high from the cannabis they use?
A: Some have absolutely zero interest in getting high, and they try to avoid the THC-containing products. Other like getting high in addition to getting help with pain and spasticity.
Q: Who should not use medical marijuana in the MS community?
A: Patients who don’t have symptoms that could respond.
I’m also very concerned about patients who are 25 years and younger because of the effects that cannabis can have on brain development out to age 25 and the higher risk of addiction in people who are younger.
Q: What do you think the future will hold on the cannabis front?
A: Now that it’s less of a taboo topic, there’s an ever-growing number of trials each year, including very high-quality studies.
Pharmaceutically produced, cannabis-based medicines will be a growing area. Epidiolex is a perfect example of that.
It’s important for physicians to know that the way cannabis-based medicine is produced by a pharmaceutical company is different in so many levels than the cannabis in states with recreational and medical marijuana.
Q: What are some ways that the pharmaceutical products are different?
A: The rigor of the production process, the standardization, the purity, the correct labeling and expiration dates. Plus, the lack of the use of pesticides and other contaminants. And they’re distributed by pharmacists.
Q: What should neurologists be thinking if they’re considering whether to recommend cannabis to their patients?
A: This is a very complex topic, and it’s not something that most of us have training in. You can’t sit down for 1 or 2 hours, get up to speed, and have your own well-informed opinion on it. You really need to put more time and effort.
Q: What are some issues that neurologists should consider?
A: You really need to find out what your state is doing about it and see how you feel about that.
How is your state administering medical and/or recreational marijuana? The administration of these programs is extremely different from state to state. Do these details satisfy you, and are you content having your patients interface with these programs?
Dr. Bowling reports no relevant disclosures.
The medical marijuana landscape is changing so fast that Colorado Neurological Institute neurologist Allen C. Bowling, MD, PhD, already needs to update a presentation he gave about cannabis in multiple sclerosis in late May.
Since then, both those facts became history over a span of 2 days.
First, on June 25, the FDA announced its approval of Epidiolex (cannabidiol) for the treatment of seizures in two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. It’s the first time the FDA has approved a drug with a purified ingredient – cannabidiol, a nonpsychoactive substance – that’s derived from marijuana.
Then, on June 26, voters in Oklahoma approved a ballot measure that allows the possession of marijuana for medical use; users must register with the state. Thirty states and the District of Columbia have made medical marijuana legal, according to the procon.org website, although the two newest ones (Oklahoma and West Virginia) are still developing procedures.
The laws vary widely. Some states don’t allow patients to smoke medical marijuana, and some don’t allow visitors to use out-of-state registry ID cards. And certain states limit the use of medical marijuana to specific conditions. Medical marijuana use by patients with MS is specifically allowed in many states, including Alaska, Arizona, Florida, Minnesota, and several others.
There’s another complexity: According to procon.org, 17 states have laws about the use of cannabidiol. In Georgia, for instance, the use of some cannabis oil is allowed for the treatment of MS and other conditions.
In the wake of the FDA ruling, Dr. Bowling spoke in an interview about cannabis, MS, and the questions that neurologists should be asking themselves.
Q: What are studies telling us about cannabis and MS?
A: There are lots of clinical studies – 19 randomized controlled trials. A consistent finding is that there’s benefit in terms of pain and people’s subjective sense of spasticity (Neurology. 2014 Apr 29;82(17):1556-63).
Q: During your CMSC presentation, you talked about how “fidelity” has been a problem in cannabis research. Could you elaborate on what you mean?
A: The products used in these studies are generally standardized, research-grade products that you can’t buy in any U.S. dispensary.
Cannabis is complex and contains more than 100 different potentially pharmacologically active molecules. You can’t conclude that if you see a product in clinical trials, you’ll then be able to walk into a dispensary for recreational or medical cannabis and get a product that produces the same effect.
Q: What have you seen in your own patient population in terms of cannabis use?
A: I find what’s been found with the studies: It helps with pain and people’s sense of muscle stiffness.
It’s especially helpful in people with pain and spasticity that breaks through in the late afternoon or at night when they’re trying to go to sleep. Just a little bit of cannabis can get them through those difficult times and improve their quality of life.
Q: What choices do patients make regarding whether to get high from the cannabis they use?
A: Some have absolutely zero interest in getting high, and they try to avoid the THC-containing products. Other like getting high in addition to getting help with pain and spasticity.
Q: Who should not use medical marijuana in the MS community?
A: Patients who don’t have symptoms that could respond.
I’m also very concerned about patients who are 25 years and younger because of the effects that cannabis can have on brain development out to age 25 and the higher risk of addiction in people who are younger.
Q: What do you think the future will hold on the cannabis front?
A: Now that it’s less of a taboo topic, there’s an ever-growing number of trials each year, including very high-quality studies.
Pharmaceutically produced, cannabis-based medicines will be a growing area. Epidiolex is a perfect example of that.
It’s important for physicians to know that the way cannabis-based medicine is produced by a pharmaceutical company is different in so many levels than the cannabis in states with recreational and medical marijuana.
Q: What are some ways that the pharmaceutical products are different?
A: The rigor of the production process, the standardization, the purity, the correct labeling and expiration dates. Plus, the lack of the use of pesticides and other contaminants. And they’re distributed by pharmacists.
Q: What should neurologists be thinking if they’re considering whether to recommend cannabis to their patients?
A: This is a very complex topic, and it’s not something that most of us have training in. You can’t sit down for 1 or 2 hours, get up to speed, and have your own well-informed opinion on it. You really need to put more time and effort.
Q: What are some issues that neurologists should consider?
A: You really need to find out what your state is doing about it and see how you feel about that.
How is your state administering medical and/or recreational marijuana? The administration of these programs is extremely different from state to state. Do these details satisfy you, and are you content having your patients interface with these programs?
Dr. Bowling reports no relevant disclosures.
Chronic kidney disease is 40% more common in T2DM than T1DM
ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.
“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”
According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m2 or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.
Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.
The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.
Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).
These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.
Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.
“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.
“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”
No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.
SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.
“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”
According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m2 or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.
Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.
The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.
Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).
These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.
Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.
“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.
“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”
No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.
SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.
“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”
According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m2 or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.
Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.
The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.
Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).
These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.
Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.
“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.
“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”
No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.
SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
REPORTING FROM ADA 2018
Key clinical point: CKD is significantly more common in patients with T2DM than those with T1DM, and albumin testing provides crucial warning signs.
Major finding: Of subjects with T2DM, 44% had signs of CKD, compared with 32% of those with T1DM.
Study details: Analysis of LabCorp blood testing of more than 1.5 million U.S. adults with diabetes from 2014-2017.
Disclosures: No study funding was reported. Authors reported various disclosures, mostly employment for Covance or its parent company, LabCorp.
Source: Cressman M et al. ADA 2018, Abstract 544-P.
Zolpidem does not boost cannabis abstinence during treatment
SAN DIEGO – Disturbed sleep is one of the symptoms of withdrawal from marijuana, and it can wreak havoc on the lives of people with cannabis use disorder who are trying to quit. Now, a new study provides more evidence about the problem and suggests that the sleep aid zolpidem is not a solution on its own.
Zolpidem seemed to help subjects sleep better, but the effect lasted only as long as they took the drug. And .
“Zolpidem or other hypnotics may have some efficacy as a pharmacotherapy to relieve short-term sleep disruption in the treatment of cannabis use disorder. But they should only be used in cases where abstinence-induced insomnia is a significant barrier to cessation and only in combination with other evidence-based interventions to address key aspects of cannabis use disorder,” study coauthor Dustin C. Lee, PhD, of Johns Hopkins University, Baltimore, said in an interview. He presented the study findings at the annual meeting of the College on Problems of Drug Dependence.
Previous research, including studies by some of the authors of the new report, suggests that people trying to withdraw from cannabis often suffer from sleep disturbances.
In a 2010 study, for instance, researchers interviewed 469 adult cannabis users in the Baltimore area who had tried to quit outside of treatment programs. Nearly half reported trouble falling asleep, while 20%-36% reported sleep-related symptoms, such as sleeping more or less than usual, having unusual dreams, and waking during the night (Drug Alcohol Depend. 2010 Sep 1;111[1-2]:120-7).
Another factor could be at play: Cannabis users may sleep better while they use the drug, then lose the benefit when they try to withdraw.
“Studies have demonstrated that acute use of cannabis reduces sleep latency and increases stage 3 sleep, informally referred to as ‘deep’ or ‘slow-wave’ sleep, which means individuals fall asleep faster and remain in deep sleep longer after using cannabis,” Dr. Lee said.
Whatever the explanation, the sleep problems during withdrawal are not helpful to users who are trying to quit. “Research indicates that cannabis cessation results in sleep problems that are a barrier to quitting,” Dr. Lee said.
For the new study, Dr. Lee and his colleagues randomly assigned 127 adults – all in a 12-week clinical trial of cannabis use disorder treatment – to receive extended-release zolpidem or placebo.
Participants underwent urine screens to test for drug use and ambulatory polysomnography to measure sleep.
A preliminary analysis found that those who received zolpidem had higher rates of cannabis abstinence during the 12 weeks and at end of treatment. But analysis showed that the differences were not statistically significant, Dr. Lee said, “which suggests that sleep is not the predominant factor driving successful cessation attempts.”
Researchers also found that sleep efficiency and sleep onset latency deteriorated to a clinically significant degree in week 1 of the study for those who took the placebo (mean sleep efficiency fell from 82% to 74%, while sleep onset latency increased from 28 to 82 minutes).
The zolpidem group did not see any significant change in sleep efficiency or sleep onset latency. However, those participants showed signs of rebound insomnia after they stopped taking zolpidem.
As for the risk of abuse of zolpidem, Dr. Lee said: “We did not see any indication of abuse among the individuals who participated in our study. We monitored this via quantitative urine toxicology testing and remote medication adherence monitoring.”
Moving forward, he said, zolpidem “may have some efficacy as a short-term therapy for sleep disruption in a subset of cannabis users. More research is needed to further evaluate the efficacy of zolpidem or other hypnotic medications in individuals who differ in withdrawal severity or demographics.”
Dr. Lee said evaluating behavioral sleep treatments would be a logical next-step in light of his team’s data.
The National Institute on Drug Abuse funded the study. Three of the authors reported no relevant disclosures, and one reported consulting/advisory links to several drug companies and several state-licensed medical cannabis cultivation or dispensary businesses.
SAN DIEGO – Disturbed sleep is one of the symptoms of withdrawal from marijuana, and it can wreak havoc on the lives of people with cannabis use disorder who are trying to quit. Now, a new study provides more evidence about the problem and suggests that the sleep aid zolpidem is not a solution on its own.
Zolpidem seemed to help subjects sleep better, but the effect lasted only as long as they took the drug. And .
“Zolpidem or other hypnotics may have some efficacy as a pharmacotherapy to relieve short-term sleep disruption in the treatment of cannabis use disorder. But they should only be used in cases where abstinence-induced insomnia is a significant barrier to cessation and only in combination with other evidence-based interventions to address key aspects of cannabis use disorder,” study coauthor Dustin C. Lee, PhD, of Johns Hopkins University, Baltimore, said in an interview. He presented the study findings at the annual meeting of the College on Problems of Drug Dependence.
Previous research, including studies by some of the authors of the new report, suggests that people trying to withdraw from cannabis often suffer from sleep disturbances.
In a 2010 study, for instance, researchers interviewed 469 adult cannabis users in the Baltimore area who had tried to quit outside of treatment programs. Nearly half reported trouble falling asleep, while 20%-36% reported sleep-related symptoms, such as sleeping more or less than usual, having unusual dreams, and waking during the night (Drug Alcohol Depend. 2010 Sep 1;111[1-2]:120-7).
Another factor could be at play: Cannabis users may sleep better while they use the drug, then lose the benefit when they try to withdraw.
“Studies have demonstrated that acute use of cannabis reduces sleep latency and increases stage 3 sleep, informally referred to as ‘deep’ or ‘slow-wave’ sleep, which means individuals fall asleep faster and remain in deep sleep longer after using cannabis,” Dr. Lee said.
Whatever the explanation, the sleep problems during withdrawal are not helpful to users who are trying to quit. “Research indicates that cannabis cessation results in sleep problems that are a barrier to quitting,” Dr. Lee said.
For the new study, Dr. Lee and his colleagues randomly assigned 127 adults – all in a 12-week clinical trial of cannabis use disorder treatment – to receive extended-release zolpidem or placebo.
Participants underwent urine screens to test for drug use and ambulatory polysomnography to measure sleep.
A preliminary analysis found that those who received zolpidem had higher rates of cannabis abstinence during the 12 weeks and at end of treatment. But analysis showed that the differences were not statistically significant, Dr. Lee said, “which suggests that sleep is not the predominant factor driving successful cessation attempts.”
Researchers also found that sleep efficiency and sleep onset latency deteriorated to a clinically significant degree in week 1 of the study for those who took the placebo (mean sleep efficiency fell from 82% to 74%, while sleep onset latency increased from 28 to 82 minutes).
The zolpidem group did not see any significant change in sleep efficiency or sleep onset latency. However, those participants showed signs of rebound insomnia after they stopped taking zolpidem.
As for the risk of abuse of zolpidem, Dr. Lee said: “We did not see any indication of abuse among the individuals who participated in our study. We monitored this via quantitative urine toxicology testing and remote medication adherence monitoring.”
Moving forward, he said, zolpidem “may have some efficacy as a short-term therapy for sleep disruption in a subset of cannabis users. More research is needed to further evaluate the efficacy of zolpidem or other hypnotic medications in individuals who differ in withdrawal severity or demographics.”
Dr. Lee said evaluating behavioral sleep treatments would be a logical next-step in light of his team’s data.
The National Institute on Drug Abuse funded the study. Three of the authors reported no relevant disclosures, and one reported consulting/advisory links to several drug companies and several state-licensed medical cannabis cultivation or dispensary businesses.
SAN DIEGO – Disturbed sleep is one of the symptoms of withdrawal from marijuana, and it can wreak havoc on the lives of people with cannabis use disorder who are trying to quit. Now, a new study provides more evidence about the problem and suggests that the sleep aid zolpidem is not a solution on its own.
Zolpidem seemed to help subjects sleep better, but the effect lasted only as long as they took the drug. And .
“Zolpidem or other hypnotics may have some efficacy as a pharmacotherapy to relieve short-term sleep disruption in the treatment of cannabis use disorder. But they should only be used in cases where abstinence-induced insomnia is a significant barrier to cessation and only in combination with other evidence-based interventions to address key aspects of cannabis use disorder,” study coauthor Dustin C. Lee, PhD, of Johns Hopkins University, Baltimore, said in an interview. He presented the study findings at the annual meeting of the College on Problems of Drug Dependence.
Previous research, including studies by some of the authors of the new report, suggests that people trying to withdraw from cannabis often suffer from sleep disturbances.
In a 2010 study, for instance, researchers interviewed 469 adult cannabis users in the Baltimore area who had tried to quit outside of treatment programs. Nearly half reported trouble falling asleep, while 20%-36% reported sleep-related symptoms, such as sleeping more or less than usual, having unusual dreams, and waking during the night (Drug Alcohol Depend. 2010 Sep 1;111[1-2]:120-7).
Another factor could be at play: Cannabis users may sleep better while they use the drug, then lose the benefit when they try to withdraw.
“Studies have demonstrated that acute use of cannabis reduces sleep latency and increases stage 3 sleep, informally referred to as ‘deep’ or ‘slow-wave’ sleep, which means individuals fall asleep faster and remain in deep sleep longer after using cannabis,” Dr. Lee said.
Whatever the explanation, the sleep problems during withdrawal are not helpful to users who are trying to quit. “Research indicates that cannabis cessation results in sleep problems that are a barrier to quitting,” Dr. Lee said.
For the new study, Dr. Lee and his colleagues randomly assigned 127 adults – all in a 12-week clinical trial of cannabis use disorder treatment – to receive extended-release zolpidem or placebo.
Participants underwent urine screens to test for drug use and ambulatory polysomnography to measure sleep.
A preliminary analysis found that those who received zolpidem had higher rates of cannabis abstinence during the 12 weeks and at end of treatment. But analysis showed that the differences were not statistically significant, Dr. Lee said, “which suggests that sleep is not the predominant factor driving successful cessation attempts.”
Researchers also found that sleep efficiency and sleep onset latency deteriorated to a clinically significant degree in week 1 of the study for those who took the placebo (mean sleep efficiency fell from 82% to 74%, while sleep onset latency increased from 28 to 82 minutes).
The zolpidem group did not see any significant change in sleep efficiency or sleep onset latency. However, those participants showed signs of rebound insomnia after they stopped taking zolpidem.
As for the risk of abuse of zolpidem, Dr. Lee said: “We did not see any indication of abuse among the individuals who participated in our study. We monitored this via quantitative urine toxicology testing and remote medication adherence monitoring.”
Moving forward, he said, zolpidem “may have some efficacy as a short-term therapy for sleep disruption in a subset of cannabis users. More research is needed to further evaluate the efficacy of zolpidem or other hypnotic medications in individuals who differ in withdrawal severity or demographics.”
Dr. Lee said evaluating behavioral sleep treatments would be a logical next-step in light of his team’s data.
The National Institute on Drug Abuse funded the study. Three of the authors reported no relevant disclosures, and one reported consulting/advisory links to several drug companies and several state-licensed medical cannabis cultivation or dispensary businesses.
REPORTING FROM CPDD 2018
Key clinical point: Zolpidem does not boost rates of abstinence during treatment for cannabis use disorder.
Major finding: Researchers did not find a statistically significant difference in cannabis abstinence rates between subjects who took zolpidem during treatment and those who did not.
Study details: Randomized, placebo-controlled trial of 127 adults with cannabis use disorder, all in a 12-week clinical trial of a treatment program, who received extended-release zolpidem or placebo.
Disclosures: Three of the authors reported no relevant disclosures, and one reported consulting/advisory links to several drug companies and several state-licensed medical cannabis cultivation or dispensary businesses.
High risk of low glucose? Hospital alerts promise a crucial heads-up
ORLANDO – Researchers have been able to sustain a dramatic reduction in hypoglycemia incidents at nine St. Louis–area hospitals, thanks to a computer algorithm that warns medical staff when patients appear to be on the road to dangerously low blood sugar levels.
The 6-year retrospective system-wide study, which was released at the annual scientific sessions of the American Diabetes Association, found that the use of the alert system lowered the annual occurrence of severe hypoglycemia events by 41% at the hospitals.
In at-risk patients – those with blood glucose levels under 90 mg/dL – the system considers several variables, such as their weight, creatinine clearance, insulin therapy, and basal insulin doses. If the algorithm considers that a patient is at high risk of a sub–40-mg/dL glucose level – dangerously low – it sends a single alert to medical staff during the patient’s stay.
The idea is that the real-time alerts will go to nurses or pharmacists who will review patient charts and then contact physicians. The doctors are expected to “make clinically appropriate changes,” Dr. Tobin said.
Earlier, Dr. Tobin and colleagues prospectively analyzed the alert system’s effectiveness at a single hospital for 5 months. The trial, a cohort intervention study, tracked 655 patients with a blood glucose level under 90 mg/dL.
In 2014, the researchers reported the results of that trial: The alert identified 390 of the patients as being at high risk for severe hypoglycemia (blood glucose under 40 mg/dL). The frequency of severe hypoglycemia events was just 3.1% in this population vs. 9.7% in unalerted patients who were also deemed to be at high risk (J Hosp Med. 2014[9]: 621-6).
For the new study, researchers extended the alert system to nine hospitals and tracked its use from 2011 to 2017.
During all visits, the number of severe hypoglycemic events fell from 2.9 to 1.7 per 1,000 at-risk patient days. (P less than .001)
At one hospital, Dr. Tobin said, the average monthly number of severe hypoglycemia incidents fell from 40 to 12.
Researchers found that the average blood glucose level post alert was 93 mg/dL vs. 74 mg/dL before alert. They also reported that the system-wide total of alerts per year ranged from 4,142 to 5,649.
“The current data reflected in our poster show that the alert process is sustainable over a wide range of clinical settings, including community hospitals of various size and complexity, as well as academic medical centers,” Dr. Tobin said.
The alert system had no effect on hyperglycemia, Dr. Tobin said.
In regard to expense, Dr. Tobin said it’s small because the alert system uses existing current staff and computer systems. Setup costs, he said, included programming, creating the alert infrastructure, and staff training
No study funding is reported. Dr. Tobin reports relationships with Novo Nordisk (advisory board, speaker’s bureau) and MannKind (speaker’s bureau). The other authors report no relevant disclosures.
SOURCE: Tobin G et al. ADA 2018. Abstract 397-P.
ORLANDO – Researchers have been able to sustain a dramatic reduction in hypoglycemia incidents at nine St. Louis–area hospitals, thanks to a computer algorithm that warns medical staff when patients appear to be on the road to dangerously low blood sugar levels.
The 6-year retrospective system-wide study, which was released at the annual scientific sessions of the American Diabetes Association, found that the use of the alert system lowered the annual occurrence of severe hypoglycemia events by 41% at the hospitals.
In at-risk patients – those with blood glucose levels under 90 mg/dL – the system considers several variables, such as their weight, creatinine clearance, insulin therapy, and basal insulin doses. If the algorithm considers that a patient is at high risk of a sub–40-mg/dL glucose level – dangerously low – it sends a single alert to medical staff during the patient’s stay.
The idea is that the real-time alerts will go to nurses or pharmacists who will review patient charts and then contact physicians. The doctors are expected to “make clinically appropriate changes,” Dr. Tobin said.
Earlier, Dr. Tobin and colleagues prospectively analyzed the alert system’s effectiveness at a single hospital for 5 months. The trial, a cohort intervention study, tracked 655 patients with a blood glucose level under 90 mg/dL.
In 2014, the researchers reported the results of that trial: The alert identified 390 of the patients as being at high risk for severe hypoglycemia (blood glucose under 40 mg/dL). The frequency of severe hypoglycemia events was just 3.1% in this population vs. 9.7% in unalerted patients who were also deemed to be at high risk (J Hosp Med. 2014[9]: 621-6).
For the new study, researchers extended the alert system to nine hospitals and tracked its use from 2011 to 2017.
During all visits, the number of severe hypoglycemic events fell from 2.9 to 1.7 per 1,000 at-risk patient days. (P less than .001)
At one hospital, Dr. Tobin said, the average monthly number of severe hypoglycemia incidents fell from 40 to 12.
Researchers found that the average blood glucose level post alert was 93 mg/dL vs. 74 mg/dL before alert. They also reported that the system-wide total of alerts per year ranged from 4,142 to 5,649.
“The current data reflected in our poster show that the alert process is sustainable over a wide range of clinical settings, including community hospitals of various size and complexity, as well as academic medical centers,” Dr. Tobin said.
The alert system had no effect on hyperglycemia, Dr. Tobin said.
In regard to expense, Dr. Tobin said it’s small because the alert system uses existing current staff and computer systems. Setup costs, he said, included programming, creating the alert infrastructure, and staff training
No study funding is reported. Dr. Tobin reports relationships with Novo Nordisk (advisory board, speaker’s bureau) and MannKind (speaker’s bureau). The other authors report no relevant disclosures.
SOURCE: Tobin G et al. ADA 2018. Abstract 397-P.
ORLANDO – Researchers have been able to sustain a dramatic reduction in hypoglycemia incidents at nine St. Louis–area hospitals, thanks to a computer algorithm that warns medical staff when patients appear to be on the road to dangerously low blood sugar levels.
The 6-year retrospective system-wide study, which was released at the annual scientific sessions of the American Diabetes Association, found that the use of the alert system lowered the annual occurrence of severe hypoglycemia events by 41% at the hospitals.
In at-risk patients – those with blood glucose levels under 90 mg/dL – the system considers several variables, such as their weight, creatinine clearance, insulin therapy, and basal insulin doses. If the algorithm considers that a patient is at high risk of a sub–40-mg/dL glucose level – dangerously low – it sends a single alert to medical staff during the patient’s stay.
The idea is that the real-time alerts will go to nurses or pharmacists who will review patient charts and then contact physicians. The doctors are expected to “make clinically appropriate changes,” Dr. Tobin said.
Earlier, Dr. Tobin and colleagues prospectively analyzed the alert system’s effectiveness at a single hospital for 5 months. The trial, a cohort intervention study, tracked 655 patients with a blood glucose level under 90 mg/dL.
In 2014, the researchers reported the results of that trial: The alert identified 390 of the patients as being at high risk for severe hypoglycemia (blood glucose under 40 mg/dL). The frequency of severe hypoglycemia events was just 3.1% in this population vs. 9.7% in unalerted patients who were also deemed to be at high risk (J Hosp Med. 2014[9]: 621-6).
For the new study, researchers extended the alert system to nine hospitals and tracked its use from 2011 to 2017.
During all visits, the number of severe hypoglycemic events fell from 2.9 to 1.7 per 1,000 at-risk patient days. (P less than .001)
At one hospital, Dr. Tobin said, the average monthly number of severe hypoglycemia incidents fell from 40 to 12.
Researchers found that the average blood glucose level post alert was 93 mg/dL vs. 74 mg/dL before alert. They also reported that the system-wide total of alerts per year ranged from 4,142 to 5,649.
“The current data reflected in our poster show that the alert process is sustainable over a wide range of clinical settings, including community hospitals of various size and complexity, as well as academic medical centers,” Dr. Tobin said.
The alert system had no effect on hyperglycemia, Dr. Tobin said.
In regard to expense, Dr. Tobin said it’s small because the alert system uses existing current staff and computer systems. Setup costs, he said, included programming, creating the alert infrastructure, and staff training
No study funding is reported. Dr. Tobin reports relationships with Novo Nordisk (advisory board, speaker’s bureau) and MannKind (speaker’s bureau). The other authors report no relevant disclosures.
SOURCE: Tobin G et al. ADA 2018. Abstract 397-P.
REPORTING FROM ADA 2018
Key clinical point: Hospitals were able to sustain lower numbers of severe hypoglycemia events over 6 years by using a prewarning alert system.
Major finding: The number of severe hypoglycemic events (below 40 mg/dL) fell from 2.9 per 1,000 at-risk patient-days to 1.7 per 1,000 at-risk patient-days.
Study details: Retrospective, system-wide study of nine hospitals with alert system in place from 2011 to 2017.
Disclosures: No funding is reported. One author reports relationships with Novo Nordisk and MannKind. The other authors report no relevant disclosures.
Source: Tobin G et al. ADA 2018. Abstract 397-P.
Fentanyl fears drive many opioid users, interviews suggest
SAN DIEGO – Many opioid users on the street are embracing homegrown “risk reduction” techniques to make sure they avoid the danger of fentanyl-laced heroin, while others seek out batches that have caused fatal overdoses because they figure these supplies must be extra-strong and desirable. “Anytime I hear that somebody OD’d off something,” said one user, “... I was like, ‘Oh, that stuff must be good. Where can I get it?’ ”
So say opioid users who are opening up to researchers about the deadly new American drug landscape.
There’s one common thread, said Daniel Ciccarone, MD, MPH, who presented findings from his team’s interviews at the annual meeting of the College on Problems of Drug Dependence. Attitudes about fentanyl are shifting, but not enough to turn the drug – which often is available instead of heroin – into a major crowd-pleaser.
“When we first went into the field, there was a strong negative opinion about fentanyl. It was not wanted; it was imposed,” said Dr. Ciccarone of the University of California at San Francisco. “While there is some shift now, in which some do want or like the fentanyl, it is not strong enough to have shifted the culture. i.e., .”
But fentanyl still is rampant, often making its way to users who do not want and might be actively trying to avoid it. According to the National Institute on Drug Abuse, or NIDA, fentanyl and fentanyl analogs were linked to more than 20,000 of the more than 64,000 fatal U.S. drug overdoses in 2016.
“The risks are greater with fentanyl and not just because it is more potent than heroin,” Dr. Ciccarone said. In addition, “the form (fentanyl vs. fentanyl analogs) and purity shifts on a daily basis, and it’s mixed with heroin in varying amounts. It is these vicissitudes in fentanyl/heroin types and purities that make the street blends dangerous for overdose.”
Dr. Ciccarone and his colleagues interviewed opioid users in Baltimore; Charleston, W. Va.; Lawrence and Lowell, Mass.; and Chicago. Information about some of the interviews was published previously (Intl J Drug Policy. 2017 Aug;46;146-55).
In another study whose results were released at the CPDD conference, researchers from Dartmouth College, Hanover, N.H., interviewed 76 opioid users (91% were white, average age was 34, half were female, and almost all had a history of substance abuse treatment).
Among the other findings of the studies:
- Some opioid users are shocked by the adulteration of heroin by fentanyl, and even dealers are surprised: “When we cut the dope, we don’t use fentanyl. The problem was that we were buying the dope already dirty with that, and we didn’t know it,” said a 42-year-old man from Lawrence, Mass.
- In the New Hampshire interviews, 84% of participants said fentanyl is the leading cause of overdose in the state. “Due to the fentanyl and the heroin, that’s how everyone that I know ended up passing away recently,” said one user.
- Also in New Hampshire, 84% of users interviewed said they’d used fentanyl before, accidentally in some cases. Also, study coauthor Andrea L. Meier said in an interview, “67% of users reported having a prescription for opioids in their lifetime due to some kind of illness or injury. Some were short-term prescriptions (injuries, C-sections, tooth extractions); others were prescribed long-term due to chronic pain or illness.”
Some say pursue fentanyl
In the New Hampshire interviews, 25% of the 84% who’d used fentanyl said they actively seek it out, with one expressing a preference for the “real dope” (heroin laced with fentanyl) versus the “maintenance dope” of heroin alone. Ms. Meier explained what that means: “We’ve heard that once you use fentanyl or fentanyl-laced heroin, heroin doesn’t adequately manage your withdrawal symptoms or give enough of a high. So they will use heroin to get by, but they really want fentanyl or fentanyl-laced heroin.”
She added: “We’ve learned that users are seeking fentanyl due to its potency (a stronger, better high with quicker onset than heroin), cost (cheaper than heroin, so more “bang for your buck”), and once they use fentanyl or fentanyl-laced heroin, heroin doesn’t have the same effect/high.”
As for the risk of overdose, “people want the best high they can get at the cheapest cost,” she said.” They presume it will be potent enough to produce an exceptional high but [they won’t] die from an overdose due to being sufficiently tolerant to handle it. Also, some just felt hopeless and weren’t afraid of an OD.”
Comments from users about fentanyl
- “The high is wonderful. It’s splendidly wonderful. It’s magnified heroin feeling by a great number,” said a 45-year-old man from Baltimore.
- “You spend the same amount of money or even less for it, and you’re getting 3 times as high as you did on heroin,” said one user in New Hampshire. “Who wouldn’t want that?”
Risk-reduction techniques embraced
- In Baltimore, a 39-year-old woman said: “I have a lot of associates that are letting me know, ‘Don’t go to that place because they selling fentanyl.’ ”
- Some users test their heroin. “Like when I get stuff I don’t know what it is, I do a little bit before I do something that I feel,” a Lawrence, Mass., female user in her 20s said. “Like, I want to kind of scale out how much I want to do. Because I don’t want to die. But these people are just doing a gram shot and just ... my friend just died 2 days ago.”
Dr. Ciccarone said some of the biggest proponents of harm-reduction among users were African Americans aged 60 and older who had used for many decades.
“They fear fentanyl and are using old-school harm reduction strategies for staying safer: “tooting” (snorting) and tester shots (small injections to test the quality),” he said. “These may seem like minor strategies, but if enough of the population applies them to their daily drug use, many deaths would be averted. In this crisis, we need all the wisdom we can get, so we should listen to these elders.”
Dr. Ciccarone’s research was funded by the National Institutes of Health and NIDA. Dr. Ciccarone reported no relevant disclosures. The Dartmouth College study was funded by NIDA, and those authors reported no relevant disclosures.
SAN DIEGO – Many opioid users on the street are embracing homegrown “risk reduction” techniques to make sure they avoid the danger of fentanyl-laced heroin, while others seek out batches that have caused fatal overdoses because they figure these supplies must be extra-strong and desirable. “Anytime I hear that somebody OD’d off something,” said one user, “... I was like, ‘Oh, that stuff must be good. Where can I get it?’ ”
So say opioid users who are opening up to researchers about the deadly new American drug landscape.
There’s one common thread, said Daniel Ciccarone, MD, MPH, who presented findings from his team’s interviews at the annual meeting of the College on Problems of Drug Dependence. Attitudes about fentanyl are shifting, but not enough to turn the drug – which often is available instead of heroin – into a major crowd-pleaser.
“When we first went into the field, there was a strong negative opinion about fentanyl. It was not wanted; it was imposed,” said Dr. Ciccarone of the University of California at San Francisco. “While there is some shift now, in which some do want or like the fentanyl, it is not strong enough to have shifted the culture. i.e., .”
But fentanyl still is rampant, often making its way to users who do not want and might be actively trying to avoid it. According to the National Institute on Drug Abuse, or NIDA, fentanyl and fentanyl analogs were linked to more than 20,000 of the more than 64,000 fatal U.S. drug overdoses in 2016.
“The risks are greater with fentanyl and not just because it is more potent than heroin,” Dr. Ciccarone said. In addition, “the form (fentanyl vs. fentanyl analogs) and purity shifts on a daily basis, and it’s mixed with heroin in varying amounts. It is these vicissitudes in fentanyl/heroin types and purities that make the street blends dangerous for overdose.”
Dr. Ciccarone and his colleagues interviewed opioid users in Baltimore; Charleston, W. Va.; Lawrence and Lowell, Mass.; and Chicago. Information about some of the interviews was published previously (Intl J Drug Policy. 2017 Aug;46;146-55).
In another study whose results were released at the CPDD conference, researchers from Dartmouth College, Hanover, N.H., interviewed 76 opioid users (91% were white, average age was 34, half were female, and almost all had a history of substance abuse treatment).
Among the other findings of the studies:
- Some opioid users are shocked by the adulteration of heroin by fentanyl, and even dealers are surprised: “When we cut the dope, we don’t use fentanyl. The problem was that we were buying the dope already dirty with that, and we didn’t know it,” said a 42-year-old man from Lawrence, Mass.
- In the New Hampshire interviews, 84% of participants said fentanyl is the leading cause of overdose in the state. “Due to the fentanyl and the heroin, that’s how everyone that I know ended up passing away recently,” said one user.
- Also in New Hampshire, 84% of users interviewed said they’d used fentanyl before, accidentally in some cases. Also, study coauthor Andrea L. Meier said in an interview, “67% of users reported having a prescription for opioids in their lifetime due to some kind of illness or injury. Some were short-term prescriptions (injuries, C-sections, tooth extractions); others were prescribed long-term due to chronic pain or illness.”
Some say pursue fentanyl
In the New Hampshire interviews, 25% of the 84% who’d used fentanyl said they actively seek it out, with one expressing a preference for the “real dope” (heroin laced with fentanyl) versus the “maintenance dope” of heroin alone. Ms. Meier explained what that means: “We’ve heard that once you use fentanyl or fentanyl-laced heroin, heroin doesn’t adequately manage your withdrawal symptoms or give enough of a high. So they will use heroin to get by, but they really want fentanyl or fentanyl-laced heroin.”
She added: “We’ve learned that users are seeking fentanyl due to its potency (a stronger, better high with quicker onset than heroin), cost (cheaper than heroin, so more “bang for your buck”), and once they use fentanyl or fentanyl-laced heroin, heroin doesn’t have the same effect/high.”
As for the risk of overdose, “people want the best high they can get at the cheapest cost,” she said.” They presume it will be potent enough to produce an exceptional high but [they won’t] die from an overdose due to being sufficiently tolerant to handle it. Also, some just felt hopeless and weren’t afraid of an OD.”
Comments from users about fentanyl
- “The high is wonderful. It’s splendidly wonderful. It’s magnified heroin feeling by a great number,” said a 45-year-old man from Baltimore.
- “You spend the same amount of money or even less for it, and you’re getting 3 times as high as you did on heroin,” said one user in New Hampshire. “Who wouldn’t want that?”
Risk-reduction techniques embraced
- In Baltimore, a 39-year-old woman said: “I have a lot of associates that are letting me know, ‘Don’t go to that place because they selling fentanyl.’ ”
- Some users test their heroin. “Like when I get stuff I don’t know what it is, I do a little bit before I do something that I feel,” a Lawrence, Mass., female user in her 20s said. “Like, I want to kind of scale out how much I want to do. Because I don’t want to die. But these people are just doing a gram shot and just ... my friend just died 2 days ago.”
Dr. Ciccarone said some of the biggest proponents of harm-reduction among users were African Americans aged 60 and older who had used for many decades.
“They fear fentanyl and are using old-school harm reduction strategies for staying safer: “tooting” (snorting) and tester shots (small injections to test the quality),” he said. “These may seem like minor strategies, but if enough of the population applies them to their daily drug use, many deaths would be averted. In this crisis, we need all the wisdom we can get, so we should listen to these elders.”
Dr. Ciccarone’s research was funded by the National Institutes of Health and NIDA. Dr. Ciccarone reported no relevant disclosures. The Dartmouth College study was funded by NIDA, and those authors reported no relevant disclosures.
SAN DIEGO – Many opioid users on the street are embracing homegrown “risk reduction” techniques to make sure they avoid the danger of fentanyl-laced heroin, while others seek out batches that have caused fatal overdoses because they figure these supplies must be extra-strong and desirable. “Anytime I hear that somebody OD’d off something,” said one user, “... I was like, ‘Oh, that stuff must be good. Where can I get it?’ ”
So say opioid users who are opening up to researchers about the deadly new American drug landscape.
There’s one common thread, said Daniel Ciccarone, MD, MPH, who presented findings from his team’s interviews at the annual meeting of the College on Problems of Drug Dependence. Attitudes about fentanyl are shifting, but not enough to turn the drug – which often is available instead of heroin – into a major crowd-pleaser.
“When we first went into the field, there was a strong negative opinion about fentanyl. It was not wanted; it was imposed,” said Dr. Ciccarone of the University of California at San Francisco. “While there is some shift now, in which some do want or like the fentanyl, it is not strong enough to have shifted the culture. i.e., .”
But fentanyl still is rampant, often making its way to users who do not want and might be actively trying to avoid it. According to the National Institute on Drug Abuse, or NIDA, fentanyl and fentanyl analogs were linked to more than 20,000 of the more than 64,000 fatal U.S. drug overdoses in 2016.
“The risks are greater with fentanyl and not just because it is more potent than heroin,” Dr. Ciccarone said. In addition, “the form (fentanyl vs. fentanyl analogs) and purity shifts on a daily basis, and it’s mixed with heroin in varying amounts. It is these vicissitudes in fentanyl/heroin types and purities that make the street blends dangerous for overdose.”
Dr. Ciccarone and his colleagues interviewed opioid users in Baltimore; Charleston, W. Va.; Lawrence and Lowell, Mass.; and Chicago. Information about some of the interviews was published previously (Intl J Drug Policy. 2017 Aug;46;146-55).
In another study whose results were released at the CPDD conference, researchers from Dartmouth College, Hanover, N.H., interviewed 76 opioid users (91% were white, average age was 34, half were female, and almost all had a history of substance abuse treatment).
Among the other findings of the studies:
- Some opioid users are shocked by the adulteration of heroin by fentanyl, and even dealers are surprised: “When we cut the dope, we don’t use fentanyl. The problem was that we were buying the dope already dirty with that, and we didn’t know it,” said a 42-year-old man from Lawrence, Mass.
- In the New Hampshire interviews, 84% of participants said fentanyl is the leading cause of overdose in the state. “Due to the fentanyl and the heroin, that’s how everyone that I know ended up passing away recently,” said one user.
- Also in New Hampshire, 84% of users interviewed said they’d used fentanyl before, accidentally in some cases. Also, study coauthor Andrea L. Meier said in an interview, “67% of users reported having a prescription for opioids in their lifetime due to some kind of illness or injury. Some were short-term prescriptions (injuries, C-sections, tooth extractions); others were prescribed long-term due to chronic pain or illness.”
Some say pursue fentanyl
In the New Hampshire interviews, 25% of the 84% who’d used fentanyl said they actively seek it out, with one expressing a preference for the “real dope” (heroin laced with fentanyl) versus the “maintenance dope” of heroin alone. Ms. Meier explained what that means: “We’ve heard that once you use fentanyl or fentanyl-laced heroin, heroin doesn’t adequately manage your withdrawal symptoms or give enough of a high. So they will use heroin to get by, but they really want fentanyl or fentanyl-laced heroin.”
She added: “We’ve learned that users are seeking fentanyl due to its potency (a stronger, better high with quicker onset than heroin), cost (cheaper than heroin, so more “bang for your buck”), and once they use fentanyl or fentanyl-laced heroin, heroin doesn’t have the same effect/high.”
As for the risk of overdose, “people want the best high they can get at the cheapest cost,” she said.” They presume it will be potent enough to produce an exceptional high but [they won’t] die from an overdose due to being sufficiently tolerant to handle it. Also, some just felt hopeless and weren’t afraid of an OD.”
Comments from users about fentanyl
- “The high is wonderful. It’s splendidly wonderful. It’s magnified heroin feeling by a great number,” said a 45-year-old man from Baltimore.
- “You spend the same amount of money or even less for it, and you’re getting 3 times as high as you did on heroin,” said one user in New Hampshire. “Who wouldn’t want that?”
Risk-reduction techniques embraced
- In Baltimore, a 39-year-old woman said: “I have a lot of associates that are letting me know, ‘Don’t go to that place because they selling fentanyl.’ ”
- Some users test their heroin. “Like when I get stuff I don’t know what it is, I do a little bit before I do something that I feel,” a Lawrence, Mass., female user in her 20s said. “Like, I want to kind of scale out how much I want to do. Because I don’t want to die. But these people are just doing a gram shot and just ... my friend just died 2 days ago.”
Dr. Ciccarone said some of the biggest proponents of harm-reduction among users were African Americans aged 60 and older who had used for many decades.
“They fear fentanyl and are using old-school harm reduction strategies for staying safer: “tooting” (snorting) and tester shots (small injections to test the quality),” he said. “These may seem like minor strategies, but if enough of the population applies them to their daily drug use, many deaths would be averted. In this crisis, we need all the wisdom we can get, so we should listen to these elders.”
Dr. Ciccarone’s research was funded by the National Institutes of Health and NIDA. Dr. Ciccarone reported no relevant disclosures. The Dartmouth College study was funded by NIDA, and those authors reported no relevant disclosures.
REPORTING FROM CPDD 2018
Methamphetamine use climbing among opioid users
SAN DIEGO – As the deadly opioid epidemic continues, a new study suggests that a fast-rising number of users are turning to another drug of abuse – methamphetamine. In some cases, a researcher says, their co-use is reminiscent of the fad for “speedball” mixtures of cocaine and heroin.
During 2011-2017, the percentage of surveyed opioid users seeking treatment who reported also using methamphetamine over the past month skyrocketed from 19% to 34%, researchers reported at the 2018 annual meeting of the College on Problems of Drug Dependence.
Use of crystal meth specifically went up by 82% and the use of prescription stimulants rose by 15%. By contrast, use of marijuana went up by just 6%, while the use of muscle relaxants and prescription sleep drugs fell by more than half.
The findings matter, because the use of multiple illicit drugs is even more dangerous than one alone, said study coauthor and doctoral candidate Matthew S. Ellis, of Washington University in St. Louis, in an interview. “Illicit opioids carry their own serious risks such as unknown purity, not knowing if heroin is laced with fentanyl, or inexperience of users who are used to clearly marked prescription pills. Add in a secondary drug, also often used in non-oral ways, and your risk for overdose is going to significantly increase.”
The rising use of methamphetamine, which comes in such forms as crystal meth, has been overshadowed by news about the opioid epidemic. Still, as a 2018 Lancet report put it, “while the opioid crisis has exploded, the lull in the methamphetamine epidemic has quietly and swiftly reversed course, now accounting for 11% of the total number of overdose deaths.”
In regard to co-use of opioids and methamphetamines, the report said, “in states including Wisconsin and Oregon, new patterns suggest they are beginning to overlap as increasing numbers of people use both drugs” (Lancet. 2018 Feb. 24;391[10122]:713).
Meanwhile, the New York Times published a story in February 2018 headlined “Meth, the forgotten killer, is back. And it’s everywhere.” It noted that meth overdose deaths in Oregon outpace those from opioids and added: “At the United States border, agents are seizing 10-20 times the amounts they did a decade ago. Methamphetamine, experts say, has never been purer, cheaper, or more lethal.”
Overall, there’s little known about co-use of opioids and methamphetamines, said study lead author Mr. Ellis. “The reason for this is that opioid use patterns and populations of users have drastically changed in the past 20 years, and continue to do so,” he said. “Methamphetamine is becoming increasingly available at the same time that heroin and illicit fentanyl are as well. Reports suggest that the United States has shifted from a market of home-grown methamphetamine to that manufactured and sent from other countries, creating a broader market than previously seen.”
For the new study, Mr. Ellis and his colleagues examined statistics from a U.S. surveillance program of opioid users entering substance abuse programs. They focused on 13,521 participants in 47 states during 2011-2017.
Of 12 drug classes examined, only co-use of methamphetamine rose significantly over the 6-year period, Mr. Ellis said.
Among demographic and geographic groups, the researchers saw the largest increases in co-use of the two drugs in the West, Northeast, and Midwest regions, in rural and suburban areas, among groups aged 18-44 years, and among whites.
Why is co-use among opioid users increasing? “We have begun to do some qualitative work with a number of participants suggesting they use opioids and methamphetamine to balance each other out,” Mr. Ellis said. “So an addict can use opioids, but if they need to go to work, they can reinvigorate themselves with methamphetamine.”
Mr. Ellis said “this is not necessarily a new trend,” noting that the co-use of the drugs is akin to the “speedball” – a mixture of cocaine and heroin designed to blend their opposite modes of action.
However, Mr. Ellis said, “ The increases in production and spread of illicit opioids and methamphetamine into an existing market of those previously using prescription opioids was a perfect storm for these two drugs to be a problem, both separately and together.”
He said researchers also are finding that “if methamphetamine is the only thing an opioid addict can find, they will use it to stave off withdrawals as well.”
Indeed, National Public Radio reported in June 2018 that “as opioids are becoming harder to obtain, more and more users are turning to cheap methamphetamine” in Ohio’s tiny Vinton County, near Columbus.
Moving forward, Mr. Ellis said, “we cannot treat substance use in a silo of a single drug. If we attempt to treat opioid abusers by simply treating their opioid abuse – and not other drugs – then we have less of a chance of success. More of a focus needs to be put on the fact that the vast majority of opioid abusers are polysubstance users.”
The study is funded by the RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance) System, an independent, nonprofit postmarketing surveillance system supported by subscription fees from pharmaceutical manufacturers that use RADARS data to track medication use and meet regulatory obligations. The study authors report no relevant disclosures.
SAN DIEGO – As the deadly opioid epidemic continues, a new study suggests that a fast-rising number of users are turning to another drug of abuse – methamphetamine. In some cases, a researcher says, their co-use is reminiscent of the fad for “speedball” mixtures of cocaine and heroin.
During 2011-2017, the percentage of surveyed opioid users seeking treatment who reported also using methamphetamine over the past month skyrocketed from 19% to 34%, researchers reported at the 2018 annual meeting of the College on Problems of Drug Dependence.
Use of crystal meth specifically went up by 82% and the use of prescription stimulants rose by 15%. By contrast, use of marijuana went up by just 6%, while the use of muscle relaxants and prescription sleep drugs fell by more than half.
The findings matter, because the use of multiple illicit drugs is even more dangerous than one alone, said study coauthor and doctoral candidate Matthew S. Ellis, of Washington University in St. Louis, in an interview. “Illicit opioids carry their own serious risks such as unknown purity, not knowing if heroin is laced with fentanyl, or inexperience of users who are used to clearly marked prescription pills. Add in a secondary drug, also often used in non-oral ways, and your risk for overdose is going to significantly increase.”
The rising use of methamphetamine, which comes in such forms as crystal meth, has been overshadowed by news about the opioid epidemic. Still, as a 2018 Lancet report put it, “while the opioid crisis has exploded, the lull in the methamphetamine epidemic has quietly and swiftly reversed course, now accounting for 11% of the total number of overdose deaths.”
In regard to co-use of opioids and methamphetamines, the report said, “in states including Wisconsin and Oregon, new patterns suggest they are beginning to overlap as increasing numbers of people use both drugs” (Lancet. 2018 Feb. 24;391[10122]:713).
Meanwhile, the New York Times published a story in February 2018 headlined “Meth, the forgotten killer, is back. And it’s everywhere.” It noted that meth overdose deaths in Oregon outpace those from opioids and added: “At the United States border, agents are seizing 10-20 times the amounts they did a decade ago. Methamphetamine, experts say, has never been purer, cheaper, or more lethal.”
Overall, there’s little known about co-use of opioids and methamphetamines, said study lead author Mr. Ellis. “The reason for this is that opioid use patterns and populations of users have drastically changed in the past 20 years, and continue to do so,” he said. “Methamphetamine is becoming increasingly available at the same time that heroin and illicit fentanyl are as well. Reports suggest that the United States has shifted from a market of home-grown methamphetamine to that manufactured and sent from other countries, creating a broader market than previously seen.”
For the new study, Mr. Ellis and his colleagues examined statistics from a U.S. surveillance program of opioid users entering substance abuse programs. They focused on 13,521 participants in 47 states during 2011-2017.
Of 12 drug classes examined, only co-use of methamphetamine rose significantly over the 6-year period, Mr. Ellis said.
Among demographic and geographic groups, the researchers saw the largest increases in co-use of the two drugs in the West, Northeast, and Midwest regions, in rural and suburban areas, among groups aged 18-44 years, and among whites.
Why is co-use among opioid users increasing? “We have begun to do some qualitative work with a number of participants suggesting they use opioids and methamphetamine to balance each other out,” Mr. Ellis said. “So an addict can use opioids, but if they need to go to work, they can reinvigorate themselves with methamphetamine.”
Mr. Ellis said “this is not necessarily a new trend,” noting that the co-use of the drugs is akin to the “speedball” – a mixture of cocaine and heroin designed to blend their opposite modes of action.
However, Mr. Ellis said, “ The increases in production and spread of illicit opioids and methamphetamine into an existing market of those previously using prescription opioids was a perfect storm for these two drugs to be a problem, both separately and together.”
He said researchers also are finding that “if methamphetamine is the only thing an opioid addict can find, they will use it to stave off withdrawals as well.”
Indeed, National Public Radio reported in June 2018 that “as opioids are becoming harder to obtain, more and more users are turning to cheap methamphetamine” in Ohio’s tiny Vinton County, near Columbus.
Moving forward, Mr. Ellis said, “we cannot treat substance use in a silo of a single drug. If we attempt to treat opioid abusers by simply treating their opioid abuse – and not other drugs – then we have less of a chance of success. More of a focus needs to be put on the fact that the vast majority of opioid abusers are polysubstance users.”
The study is funded by the RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance) System, an independent, nonprofit postmarketing surveillance system supported by subscription fees from pharmaceutical manufacturers that use RADARS data to track medication use and meet regulatory obligations. The study authors report no relevant disclosures.
SAN DIEGO – As the deadly opioid epidemic continues, a new study suggests that a fast-rising number of users are turning to another drug of abuse – methamphetamine. In some cases, a researcher says, their co-use is reminiscent of the fad for “speedball” mixtures of cocaine and heroin.
During 2011-2017, the percentage of surveyed opioid users seeking treatment who reported also using methamphetamine over the past month skyrocketed from 19% to 34%, researchers reported at the 2018 annual meeting of the College on Problems of Drug Dependence.
Use of crystal meth specifically went up by 82% and the use of prescription stimulants rose by 15%. By contrast, use of marijuana went up by just 6%, while the use of muscle relaxants and prescription sleep drugs fell by more than half.
The findings matter, because the use of multiple illicit drugs is even more dangerous than one alone, said study coauthor and doctoral candidate Matthew S. Ellis, of Washington University in St. Louis, in an interview. “Illicit opioids carry their own serious risks such as unknown purity, not knowing if heroin is laced with fentanyl, or inexperience of users who are used to clearly marked prescription pills. Add in a secondary drug, also often used in non-oral ways, and your risk for overdose is going to significantly increase.”
The rising use of methamphetamine, which comes in such forms as crystal meth, has been overshadowed by news about the opioid epidemic. Still, as a 2018 Lancet report put it, “while the opioid crisis has exploded, the lull in the methamphetamine epidemic has quietly and swiftly reversed course, now accounting for 11% of the total number of overdose deaths.”
In regard to co-use of opioids and methamphetamines, the report said, “in states including Wisconsin and Oregon, new patterns suggest they are beginning to overlap as increasing numbers of people use both drugs” (Lancet. 2018 Feb. 24;391[10122]:713).
Meanwhile, the New York Times published a story in February 2018 headlined “Meth, the forgotten killer, is back. And it’s everywhere.” It noted that meth overdose deaths in Oregon outpace those from opioids and added: “At the United States border, agents are seizing 10-20 times the amounts they did a decade ago. Methamphetamine, experts say, has never been purer, cheaper, or more lethal.”
Overall, there’s little known about co-use of opioids and methamphetamines, said study lead author Mr. Ellis. “The reason for this is that opioid use patterns and populations of users have drastically changed in the past 20 years, and continue to do so,” he said. “Methamphetamine is becoming increasingly available at the same time that heroin and illicit fentanyl are as well. Reports suggest that the United States has shifted from a market of home-grown methamphetamine to that manufactured and sent from other countries, creating a broader market than previously seen.”
For the new study, Mr. Ellis and his colleagues examined statistics from a U.S. surveillance program of opioid users entering substance abuse programs. They focused on 13,521 participants in 47 states during 2011-2017.
Of 12 drug classes examined, only co-use of methamphetamine rose significantly over the 6-year period, Mr. Ellis said.
Among demographic and geographic groups, the researchers saw the largest increases in co-use of the two drugs in the West, Northeast, and Midwest regions, in rural and suburban areas, among groups aged 18-44 years, and among whites.
Why is co-use among opioid users increasing? “We have begun to do some qualitative work with a number of participants suggesting they use opioids and methamphetamine to balance each other out,” Mr. Ellis said. “So an addict can use opioids, but if they need to go to work, they can reinvigorate themselves with methamphetamine.”
Mr. Ellis said “this is not necessarily a new trend,” noting that the co-use of the drugs is akin to the “speedball” – a mixture of cocaine and heroin designed to blend their opposite modes of action.
However, Mr. Ellis said, “ The increases in production and spread of illicit opioids and methamphetamine into an existing market of those previously using prescription opioids was a perfect storm for these two drugs to be a problem, both separately and together.”
He said researchers also are finding that “if methamphetamine is the only thing an opioid addict can find, they will use it to stave off withdrawals as well.”
Indeed, National Public Radio reported in June 2018 that “as opioids are becoming harder to obtain, more and more users are turning to cheap methamphetamine” in Ohio’s tiny Vinton County, near Columbus.
Moving forward, Mr. Ellis said, “we cannot treat substance use in a silo of a single drug. If we attempt to treat opioid abusers by simply treating their opioid abuse – and not other drugs – then we have less of a chance of success. More of a focus needs to be put on the fact that the vast majority of opioid abusers are polysubstance users.”
The study is funded by the RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance) System, an independent, nonprofit postmarketing surveillance system supported by subscription fees from pharmaceutical manufacturers that use RADARS data to track medication use and meet regulatory obligations. The study authors report no relevant disclosures.
REPORTING FROM CPDD 2018
Key clinical point: The percentage of opioid users who also use methamphetamine is on the rise.
Major finding: During 2011-2017, the percentage of opioid users reporting methamphetamine use over the past month grew from 19% to 34%.
Study details: Analysis of 2011-2017 data from 13,521 opioid-using participants entering substance abuse programs.
Disclosures: The study is funded by the RADARS System, an independent, nonprofit postmarketing surveillance system supported by subscription fees from pharmaceutical manufacturers that use RADARS data to track medication use and meet regulatory obligations. The study authors report no relevant disclosures.