Clinical Neurology News

Compared with placebo, opioids provide very modest improvements in chronic noncancer pain and physical functioning that decrease over time, according to the authors of a systematic review and meta-analysis of nearly 100 randomized clinical trials.

There was little difference in pain control between opioids and nonopioid alternatives such as NSAIDs in a subset of nine such comparative trials, reported the authors, led by Jason W. Busse, DC, PhD, of the department of anesthesia at McMaster University, Hamilton, Ont.

Pain benefits of opioids decreased over time in longer trials, possibly because of opioid tolerance or hyperalgesia, a condition marked by hypersensitivity to pain. “A reduced association with benefit over time might lead to prescription of higher opioid doses and consequent harms,” Dr. Busse and his coauthors wrote in JAMA.

The meta-analysis included 96 randomized clinical trials including 26,169 patients with chronic noncancer pain.

Opioid treatment did significantly improve pain and physical function versus placebo, though the magnitude of benefit was small, according to the investigators. The reduction in pain was –0.69 cm on a 10-cm visual analog scale (P less than .001), based on high-quality evidence from 42 randomized, controlled trials that followed patients for at least 3 months.

The improvement in physical functioning was likewise significant but small at 2.04 out of 100 points on the SF-36 physical component score (P less than .001). Emotional and role functioning were not significantly improved by opioid use.

Opioid use was linked to increased vomiting incidence versus placebo, with a relative risk of 4.12 (95% CI, 3.34-5.07; P less than .001) for patients in “nonenrichment” trials – those studies that included all patients regardless of whether or not they reported lack of improvement or had substantial adverse events during a study run-in period.

Nausea, constipation, dizziness, drowsiness, pruritus, and dry mouth were also linked to opioid use as compared with placebo, Dr. Busse and his colleagues reported.

The benefit of opioids and nonopioid alternatives appeared to be similar in this meta-analysis, though the available evidence from comparative studies was of low to moderate quality, the authors advised.

In moderate-quality evidence from nine clinical trials of opioids versus NSAIDs including 1,431 patients, there was no difference in pain relief between the two interventions, the investigators said. Moreover, comparisons of physician functioning also suggested no difference, while opioids were associated with more vomiting.

Both tricyclic antidepressants and synthetic cannabinoids offered similar pain relief, compared with opioids, based on low-quality clinical trial evidence, they added, while moderate-quality evidence suggested opioids offered superior pain relief, compared with anticonvulsants.

Support for the study came from the Canadian Institutes of Health Research and Health Canada. One study coauthor reported receiving personal fees from Purdue Pharma and the Nova Scotia College of Physicians and Surgeons.

SOURCE: Busse JW et al. JAMA. 2018;320(23):2448-60.

Compared with placebo, opioids provide very modest improvements in chronic noncancer pain and physical functioning that decrease over time, according to the authors of a systematic review and meta-analysis of nearly 100 randomized clinical trials.

There was little difference in pain control between opioids and nonopioid alternatives such as NSAIDs in a subset of nine such comparative trials, reported the authors, led by Jason W. Busse, DC, PhD, of the department of anesthesia at McMaster University, Hamilton, Ont.

Pain benefits of opioids decreased over time in longer trials, possibly because of opioid tolerance or hyperalgesia, a condition marked by hypersensitivity to pain. “A reduced association with benefit over time might lead to prescription of higher opioid doses and consequent harms,” Dr. Busse and his coauthors wrote in JAMA.

The meta-analysis included 96 randomized clinical trials including 26,169 patients with chronic noncancer pain.

Opioid treatment did significantly improve pain and physical function versus placebo, though the magnitude of benefit was small, according to the investigators. The reduction in pain was –0.69 cm on a 10-cm visual analog scale (P less than .001), based on high-quality evidence from 42 randomized, controlled trials that followed patients for at least 3 months.

The improvement in physical functioning was likewise significant but small at 2.04 out of 100 points on the SF-36 physical component score (P less than .001). Emotional and role functioning were not significantly improved by opioid use.

Opioid use was linked to increased vomiting incidence versus placebo, with a relative risk of 4.12 (95% CI, 3.34-5.07; P less than .001) for patients in “nonenrichment” trials – those studies that included all patients regardless of whether or not they reported lack of improvement or had substantial adverse events during a study run-in period.

Nausea, constipation, dizziness, drowsiness, pruritus, and dry mouth were also linked to opioid use as compared with placebo, Dr. Busse and his colleagues reported.

The benefit of opioids and nonopioid alternatives appeared to be similar in this meta-analysis, though the available evidence from comparative studies was of low to moderate quality, the authors advised.

In moderate-quality evidence from nine clinical trials of opioids versus NSAIDs including 1,431 patients, there was no difference in pain relief between the two interventions, the investigators said. Moreover, comparisons of physician functioning also suggested no difference, while opioids were associated with more vomiting.

Both tricyclic antidepressants and synthetic cannabinoids offered similar pain relief, compared with opioids, based on low-quality clinical trial evidence, they added, while moderate-quality evidence suggested opioids offered superior pain relief, compared with anticonvulsants.

Support for the study came from the Canadian Institutes of Health Research and Health Canada. One study coauthor reported receiving personal fees from Purdue Pharma and the Nova Scotia College of Physicians and Surgeons.

SOURCE: Busse JW et al. JAMA. 2018;320(23):2448-60.

Compared with placebo, opioids provide very modest improvements in chronic noncancer pain and physical functioning that decrease over time, according to the authors of a systematic review and meta-analysis of nearly 100 randomized clinical trials.

There was little difference in pain control between opioids and nonopioid alternatives such as NSAIDs in a subset of nine such comparative trials, reported the authors, led by Jason W. Busse, DC, PhD, of the department of anesthesia at McMaster University, Hamilton, Ont.

Pain benefits of opioids decreased over time in longer trials, possibly because of opioid tolerance or hyperalgesia, a condition marked by hypersensitivity to pain. “A reduced association with benefit over time might lead to prescription of higher opioid doses and consequent harms,” Dr. Busse and his coauthors wrote in JAMA.

The meta-analysis included 96 randomized clinical trials including 26,169 patients with chronic noncancer pain.

Opioid treatment did significantly improve pain and physical function versus placebo, though the magnitude of benefit was small, according to the investigators. The reduction in pain was –0.69 cm on a 10-cm visual analog scale (P less than .001), based on high-quality evidence from 42 randomized, controlled trials that followed patients for at least 3 months.

The improvement in physical functioning was likewise significant but small at 2.04 out of 100 points on the SF-36 physical component score (P less than .001). Emotional and role functioning were not significantly improved by opioid use.

Opioid use was linked to increased vomiting incidence versus placebo, with a relative risk of 4.12 (95% CI, 3.34-5.07; P less than .001) for patients in “nonenrichment” trials – those studies that included all patients regardless of whether or not they reported lack of improvement or had substantial adverse events during a study run-in period.

Nausea, constipation, dizziness, drowsiness, pruritus, and dry mouth were also linked to opioid use as compared with placebo, Dr. Busse and his colleagues reported.

The benefit of opioids and nonopioid alternatives appeared to be similar in this meta-analysis, though the available evidence from comparative studies was of low to moderate quality, the authors advised.

In moderate-quality evidence from nine clinical trials of opioids versus NSAIDs including 1,431 patients, there was no difference in pain relief between the two interventions, the investigators said. Moreover, comparisons of physician functioning also suggested no difference, while opioids were associated with more vomiting.

Both tricyclic antidepressants and synthetic cannabinoids offered similar pain relief, compared with opioids, based on low-quality clinical trial evidence, they added, while moderate-quality evidence suggested opioids offered superior pain relief, compared with anticonvulsants.

Support for the study came from the Canadian Institutes of Health Research and Health Canada. One study coauthor reported receiving personal fees from Purdue Pharma and the Nova Scotia College of Physicians and Surgeons.

SOURCE: Busse JW et al. JAMA. 2018;320(23):2448-60.

CHICAGO – High-risk hospitalized patients with atrial fibrillation (AF) whose doctors monitored them with a computerized alert system were more than twice as likely to be on anticoagulation and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.

“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”

The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.

Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA₂DS₂-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).

“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.

The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).

One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”

Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.

Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.

Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.

“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”

Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.

CHICAGO – High-risk hospitalized patients with atrial fibrillation (AF) whose doctors monitored them with a computerized alert system were more than twice as likely to be on anticoagulation and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.

“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”

The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.

Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA₂DS₂-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).

“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.

The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).

One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”

Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.

Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.

Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.

“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”

Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.

CHICAGO – High-risk hospitalized patients with atrial fibrillation (AF) whose doctors monitored them with a computerized alert system were more than twice as likely to be on anticoagulation and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.

“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”

The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.

Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA₂DS₂-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).

“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.

The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).

One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”

Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.

Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.

Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.

“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”

Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.

The future of the Affordable Care Act after a ruling in Texas. Also today, baracitinib findings have immediate clinical relevance for patients with RA, a look at how often epileptic patients have treatment delayed, and the FDA issues an alert after e-cigarette liquids were found containing erectile dysfunction medication.
 

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The future of the Affordable Care Act after a ruling in Texas. Also today, baracitinib findings have immediate clinical relevance for patients with RA, a look at how often epileptic patients have treatment delayed, and the FDA issues an alert after e-cigarette liquids were found containing erectile dysfunction medication.
 

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

The future of the Affordable Care Act after a ruling in Texas. Also today, baracitinib findings have immediate clinical relevance for patients with RA, a look at how often epileptic patients have treatment delayed, and the FDA issues an alert after e-cigarette liquids were found containing erectile dysfunction medication.
 

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

The future of the Affordable Care Act is threatened – again – this time by a ruling Friday from a federal district court judge in Texas.

Judge Reed C. O’Connor struck down the law, siding with a group of 18 Republican state attorneys general and two GOP governors who brought the case. Judge O’Connor said the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.

That tax measure eliminated the penalty for not having insurance. An earlier Supreme Court decision upheld the ACA based on the view that the penalty was a tax and thus the law was valid because it relied on appropriate power allowed Congress under the Constitution. Judge O’Connor’s decision said that without that penalty, the law no longer met that constitutional test.

“In some ways, the question before the court involves the intent of both the 2010 and 2017 Congresses,” Judge O’Connor wrote in his 55-page decision. “The former enacted the ACA. The latter sawed off the last leg it stood on.”

The decision came just hours before the end of open enrollment for ACA plans in most states that use the federal HealthCare.gov insurance exchange. It is not expected that the ruling will impact the coverage for those people – the final decision will likely not come until the case reaches the Supreme Court again.

Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, which oversees those insurance exchanges, said in a tweet: “The recent federal court decision is still moving through the courts, and the exchanges are still open for business and we will continue with open enrollment. There is no impact to current coverage or coverage in a 2019 plan.”

The 16 Democratic state attorneys general who intervened in the case to defend the health law immediately vowed to appeal.

“The ACA has already survived more than 70 unsuccessful repeal attempts and withstood scrutiny in the Supreme Court,” said a statement from California Attorney General Xavier Becerra. “Today’s misguided ruling will not deter us: our coalition will continue to fight in court for the health and wellbeing of all Americans.”

It is all but certain the case will become the third time the Supreme Court decides a constitutional question related to the ACA. In addition to upholding the law in 2012, the court rejected another challenge to the law in 2015.

It is hard to overstate what would happen to the nation’s health care system if the decision is ultimately upheld. The Affordable Care Act touched almost every aspect of health care, from Medicare and Medicaid to generic biologic drugs, the Indian Health Service, and public health changes like calorie counts on menus.

The case, Texas v. United States, was filed in February. The plaintiffs argued that because the Supreme Court upheld the ACA in 2012 as a constitutional use of its taxing power, the elimination of the tax makes the rest of the law unconstitutional.

In June, the Justice Department announced it would not fully defend the law in court. While the Trump administration said it did not agree with the plaintiffs that the tax law meant the entire ACA was unconstitutional, it said that the provisions of the law guaranteeing that people with preexisting health conditions could purchase coverage at the same price as everyone else were so inextricably linked to the tax penalty that they should be struck.

The administration urged the court to declare those provisions invalid beginning Jan. 1, 2019. That is the day the tax penalty for not having insurance disappears.

The protections for people with preexisting conditions was one of the top health issues in the midterm elections in November. While the issue mostly played to the advantage of Democrats, one of the Republican plaintiffs, Missouri Attorney General Josh Hawley, defeated Democratic incumbent Sen. Claire McCaskill. Another plaintiff, West Virginia Attorney General Patrick Morrisey, lost to Democratic incumbent Sen. Joe Manchin.

President Donald Trump was quick to take a victory lap, and pressed Senate Majority Leader Mitch McConnell (R-Ky.) and presumed incoming House Speaker Nancy Pelosi (D-Calif.) to fix the problem. He tweeted Friday night that “As I predicted all along, Obamacare has been struck down as an UNCONSTITUTIONAL disaster! Now Congress must pass a STRONG law that provides GREAT healthcare and protects pre-existing conditions. Mitch and Nancy, get it done!”

But congressional leaders were quick to point out that the suit is far from over.

“The ruling seems to be based on faulty legal reasoning and hopefully it will be overturned,” said a statement from Senate Minority Leader Chuck Schumer (D-N.Y.).

Many legal experts agreed with that. “This is insanity in print, and it will not stand up on appeal,” tweeted University of Michigan Law School professor Nicholas Bagley, an expert in health law.

Even some conservatives were left scratching their heads. “Congress acted last year to repeal the mandate, but leave everything else in place and the courts should have deferred to that,” tweeted former congressional GOP aide Chris Jacobs.


Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
 

The future of the Affordable Care Act is threatened – again – this time by a ruling Friday from a federal district court judge in Texas.

Judge Reed C. O’Connor struck down the law, siding with a group of 18 Republican state attorneys general and two GOP governors who brought the case. Judge O’Connor said the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.

That tax measure eliminated the penalty for not having insurance. An earlier Supreme Court decision upheld the ACA based on the view that the penalty was a tax and thus the law was valid because it relied on appropriate power allowed Congress under the Constitution. Judge O’Connor’s decision said that without that penalty, the law no longer met that constitutional test.

“In some ways, the question before the court involves the intent of both the 2010 and 2017 Congresses,” Judge O’Connor wrote in his 55-page decision. “The former enacted the ACA. The latter sawed off the last leg it stood on.”

The decision came just hours before the end of open enrollment for ACA plans in most states that use the federal HealthCare.gov insurance exchange. It is not expected that the ruling will impact the coverage for those people – the final decision will likely not come until the case reaches the Supreme Court again.

Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, which oversees those insurance exchanges, said in a tweet: “The recent federal court decision is still moving through the courts, and the exchanges are still open for business and we will continue with open enrollment. There is no impact to current coverage or coverage in a 2019 plan.”

The 16 Democratic state attorneys general who intervened in the case to defend the health law immediately vowed to appeal.

“The ACA has already survived more than 70 unsuccessful repeal attempts and withstood scrutiny in the Supreme Court,” said a statement from California Attorney General Xavier Becerra. “Today’s misguided ruling will not deter us: our coalition will continue to fight in court for the health and wellbeing of all Americans.”

It is all but certain the case will become the third time the Supreme Court decides a constitutional question related to the ACA. In addition to upholding the law in 2012, the court rejected another challenge to the law in 2015.

It is hard to overstate what would happen to the nation’s health care system if the decision is ultimately upheld. The Affordable Care Act touched almost every aspect of health care, from Medicare and Medicaid to generic biologic drugs, the Indian Health Service, and public health changes like calorie counts on menus.

The case, Texas v. United States, was filed in February. The plaintiffs argued that because the Supreme Court upheld the ACA in 2012 as a constitutional use of its taxing power, the elimination of the tax makes the rest of the law unconstitutional.

In June, the Justice Department announced it would not fully defend the law in court. While the Trump administration said it did not agree with the plaintiffs that the tax law meant the entire ACA was unconstitutional, it said that the provisions of the law guaranteeing that people with preexisting health conditions could purchase coverage at the same price as everyone else were so inextricably linked to the tax penalty that they should be struck.

The administration urged the court to declare those provisions invalid beginning Jan. 1, 2019. That is the day the tax penalty for not having insurance disappears.

The protections for people with preexisting conditions was one of the top health issues in the midterm elections in November. While the issue mostly played to the advantage of Democrats, one of the Republican plaintiffs, Missouri Attorney General Josh Hawley, defeated Democratic incumbent Sen. Claire McCaskill. Another plaintiff, West Virginia Attorney General Patrick Morrisey, lost to Democratic incumbent Sen. Joe Manchin.

President Donald Trump was quick to take a victory lap, and pressed Senate Majority Leader Mitch McConnell (R-Ky.) and presumed incoming House Speaker Nancy Pelosi (D-Calif.) to fix the problem. He tweeted Friday night that “As I predicted all along, Obamacare has been struck down as an UNCONSTITUTIONAL disaster! Now Congress must pass a STRONG law that provides GREAT healthcare and protects pre-existing conditions. Mitch and Nancy, get it done!”

But congressional leaders were quick to point out that the suit is far from over.

“The ruling seems to be based on faulty legal reasoning and hopefully it will be overturned,” said a statement from Senate Minority Leader Chuck Schumer (D-N.Y.).

Many legal experts agreed with that. “This is insanity in print, and it will not stand up on appeal,” tweeted University of Michigan Law School professor Nicholas Bagley, an expert in health law.

Even some conservatives were left scratching their heads. “Congress acted last year to repeal the mandate, but leave everything else in place and the courts should have deferred to that,” tweeted former congressional GOP aide Chris Jacobs.


Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
 

The future of the Affordable Care Act is threatened – again – this time by a ruling Friday from a federal district court judge in Texas.

Judge Reed C. O’Connor struck down the law, siding with a group of 18 Republican state attorneys general and two GOP governors who brought the case. Judge O’Connor said the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.

That tax measure eliminated the penalty for not having insurance. An earlier Supreme Court decision upheld the ACA based on the view that the penalty was a tax and thus the law was valid because it relied on appropriate power allowed Congress under the Constitution. Judge O’Connor’s decision said that without that penalty, the law no longer met that constitutional test.

“In some ways, the question before the court involves the intent of both the 2010 and 2017 Congresses,” Judge O’Connor wrote in his 55-page decision. “The former enacted the ACA. The latter sawed off the last leg it stood on.”

The decision came just hours before the end of open enrollment for ACA plans in most states that use the federal HealthCare.gov insurance exchange. It is not expected that the ruling will impact the coverage for those people – the final decision will likely not come until the case reaches the Supreme Court again.

Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, which oversees those insurance exchanges, said in a tweet: “The recent federal court decision is still moving through the courts, and the exchanges are still open for business and we will continue with open enrollment. There is no impact to current coverage or coverage in a 2019 plan.”

The 16 Democratic state attorneys general who intervened in the case to defend the health law immediately vowed to appeal.

“The ACA has already survived more than 70 unsuccessful repeal attempts and withstood scrutiny in the Supreme Court,” said a statement from California Attorney General Xavier Becerra. “Today’s misguided ruling will not deter us: our coalition will continue to fight in court for the health and wellbeing of all Americans.”

It is all but certain the case will become the third time the Supreme Court decides a constitutional question related to the ACA. In addition to upholding the law in 2012, the court rejected another challenge to the law in 2015.

It is hard to overstate what would happen to the nation’s health care system if the decision is ultimately upheld. The Affordable Care Act touched almost every aspect of health care, from Medicare and Medicaid to generic biologic drugs, the Indian Health Service, and public health changes like calorie counts on menus.

The case, Texas v. United States, was filed in February. The plaintiffs argued that because the Supreme Court upheld the ACA in 2012 as a constitutional use of its taxing power, the elimination of the tax makes the rest of the law unconstitutional.

In June, the Justice Department announced it would not fully defend the law in court. While the Trump administration said it did not agree with the plaintiffs that the tax law meant the entire ACA was unconstitutional, it said that the provisions of the law guaranteeing that people with preexisting health conditions could purchase coverage at the same price as everyone else were so inextricably linked to the tax penalty that they should be struck.

The administration urged the court to declare those provisions invalid beginning Jan. 1, 2019. That is the day the tax penalty for not having insurance disappears.

The protections for people with preexisting conditions was one of the top health issues in the midterm elections in November. While the issue mostly played to the advantage of Democrats, one of the Republican plaintiffs, Missouri Attorney General Josh Hawley, defeated Democratic incumbent Sen. Claire McCaskill. Another plaintiff, West Virginia Attorney General Patrick Morrisey, lost to Democratic incumbent Sen. Joe Manchin.

President Donald Trump was quick to take a victory lap, and pressed Senate Majority Leader Mitch McConnell (R-Ky.) and presumed incoming House Speaker Nancy Pelosi (D-Calif.) to fix the problem. He tweeted Friday night that “As I predicted all along, Obamacare has been struck down as an UNCONSTITUTIONAL disaster! Now Congress must pass a STRONG law that provides GREAT healthcare and protects pre-existing conditions. Mitch and Nancy, get it done!”

But congressional leaders were quick to point out that the suit is far from over.

“The ruling seems to be based on faulty legal reasoning and hopefully it will be overturned,” said a statement from Senate Minority Leader Chuck Schumer (D-N.Y.).

Many legal experts agreed with that. “This is insanity in print, and it will not stand up on appeal,” tweeted University of Michigan Law School professor Nicholas Bagley, an expert in health law.

Even some conservatives were left scratching their heads. “Congress acted last year to repeal the mandate, but leave everything else in place and the courts should have deferred to that,” tweeted former congressional GOP aide Chris Jacobs.


Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
 

MONTREAL – Enhanced and prolonged rhythm monitoring for atrial fibrillation in patients with a recent acute ischemic stroke did not find more arrhythmias, it just found them faster, in a randomized study with 398 German patients.

Mitchel L. Zoler/MDedge News

“Prolonged and enhanced monitoring identified atrial fibrillation cases that otherwise were detected years later,” Rolf Wachter, MD, said at the World Stroke Congress. Enhanced and prolonged monitoring (EPM) “should be considered for all stroke patients, regardless of the suspected stroke etiology, if detection of atrial fibrillation is of clinical relevance,” said Dr. Wachter, a cardiologist and professor at the University Clinic in Leipzig, Germany.

Based on 3-year follow-up of patients enrolled in the FIND-AF study, which randomized patients within 7 days of an acute ischemic stroke to either EPM for atrial fibrillation (AF) or standard work-up and follow-up, Dr. Wachter calculated that every six such patients who underwent EMP for AF yielded one added patient who could receive anticoagulant prophylaxis for 1 year, an effect that should result in fewer incident strokes and deaths. The data he reported showed after 3 years a “favorable trend” toward fewer strokes and deaths among patients who underwent EPM.

FIND-AF RANDOMISED (A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients) ran at four German centers during May 2013–August 2014. It enrolled 398 patients aged 60 years or older within 7 days of an acute ischemic stroke who were in sinus rhythm and had no AF history. Enrolled patients could have any type of suspected stroke etiology, but the study excluded patients with severe stenosis in their ipsilateral carotid or intracranial arteries. The study randomized patients to received EPM or a standard work-up. The “enhanced” part of EPM meant review of Holter monitor recordings by a single, dedicated core laboratory. The “prolonged” part meant routinely screening patients for an atrial arrhythmia using a Holter monitor worn for 10 consecutive days on three occasions: at entry into the study, 3 months later, and 6 months later.

The study’s primary endpoint was the number of patients diagnosed with AF after 6 months, which was 27 of 200 patients (13.5%) in the EPM arm and 9 of 198 patients (4.5%) in the control arm, a statistically significant difference, Dr. Wachter and his associates reported in Lancet Neurology (2017 Apr 1;16[4]:282-90).

The additional 30 months of follow-up included in the new report by Dr. Wachter resulted in identification of 3 more patients with AF in the EPM group and 13 more patients in the control arm, which brought the total number of patients with AF identified over 3 years to 30 in the EPM group (15%), and 22 in the control group (11%), a difference that was not statistically significant. In other words, both approaches found roughly the same percentage of patients with AF, but the EPM method found them quicker.

During the extended 36-month follow-up, 12 patients in the EPM group had an ischemic stroke and 9 patients died, with a combined stroke and death rate of about 8%. In the control group, 19 patients had a second ischemic stroke and 13 died, with a combined rate of about 15%. A statistical test of the difference between the combined stroke and death rates in these two groups produced a P value of .08.

FIND-AF was funded by Boehringer Ingelheim. Dr. Wachter has been a speaker on behalf of and has received research funding from Boehringer Ingelheim, and he has also been a speaker on behalf of Bayer, BMS/Pfizer, and Daiichi Sankyo.

mzoler@mdedge.com

SOURCE: Wachter R et al. World Stroke Congress, Abstract.

MONTREAL – Enhanced and prolonged rhythm monitoring for atrial fibrillation in patients with a recent acute ischemic stroke did not find more arrhythmias, it just found them faster, in a randomized study with 398 German patients.

Mitchel L. Zoler/MDedge News

“Prolonged and enhanced monitoring identified atrial fibrillation cases that otherwise were detected years later,” Rolf Wachter, MD, said at the World Stroke Congress. Enhanced and prolonged monitoring (EPM) “should be considered for all stroke patients, regardless of the suspected stroke etiology, if detection of atrial fibrillation is of clinical relevance,” said Dr. Wachter, a cardiologist and professor at the University Clinic in Leipzig, Germany.

Based on 3-year follow-up of patients enrolled in the FIND-AF study, which randomized patients within 7 days of an acute ischemic stroke to either EPM for atrial fibrillation (AF) or standard work-up and follow-up, Dr. Wachter calculated that every six such patients who underwent EMP for AF yielded one added patient who could receive anticoagulant prophylaxis for 1 year, an effect that should result in fewer incident strokes and deaths. The data he reported showed after 3 years a “favorable trend” toward fewer strokes and deaths among patients who underwent EPM.

FIND-AF RANDOMISED (A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients) ran at four German centers during May 2013–August 2014. It enrolled 398 patients aged 60 years or older within 7 days of an acute ischemic stroke who were in sinus rhythm and had no AF history. Enrolled patients could have any type of suspected stroke etiology, but the study excluded patients with severe stenosis in their ipsilateral carotid or intracranial arteries. The study randomized patients to received EPM or a standard work-up. The “enhanced” part of EPM meant review of Holter monitor recordings by a single, dedicated core laboratory. The “prolonged” part meant routinely screening patients for an atrial arrhythmia using a Holter monitor worn for 10 consecutive days on three occasions: at entry into the study, 3 months later, and 6 months later.

The study’s primary endpoint was the number of patients diagnosed with AF after 6 months, which was 27 of 200 patients (13.5%) in the EPM arm and 9 of 198 patients (4.5%) in the control arm, a statistically significant difference, Dr. Wachter and his associates reported in Lancet Neurology (2017 Apr 1;16[4]:282-90).

The additional 30 months of follow-up included in the new report by Dr. Wachter resulted in identification of 3 more patients with AF in the EPM group and 13 more patients in the control arm, which brought the total number of patients with AF identified over 3 years to 30 in the EPM group (15%), and 22 in the control group (11%), a difference that was not statistically significant. In other words, both approaches found roughly the same percentage of patients with AF, but the EPM method found them quicker.

During the extended 36-month follow-up, 12 patients in the EPM group had an ischemic stroke and 9 patients died, with a combined stroke and death rate of about 8%. In the control group, 19 patients had a second ischemic stroke and 13 died, with a combined rate of about 15%. A statistical test of the difference between the combined stroke and death rates in these two groups produced a P value of .08.

FIND-AF was funded by Boehringer Ingelheim. Dr. Wachter has been a speaker on behalf of and has received research funding from Boehringer Ingelheim, and he has also been a speaker on behalf of Bayer, BMS/Pfizer, and Daiichi Sankyo.

mzoler@mdedge.com

SOURCE: Wachter R et al. World Stroke Congress, Abstract.

MONTREAL – Enhanced and prolonged rhythm monitoring for atrial fibrillation in patients with a recent acute ischemic stroke did not find more arrhythmias, it just found them faster, in a randomized study with 398 German patients.

Mitchel L. Zoler/MDedge News

“Prolonged and enhanced monitoring identified atrial fibrillation cases that otherwise were detected years later,” Rolf Wachter, MD, said at the World Stroke Congress. Enhanced and prolonged monitoring (EPM) “should be considered for all stroke patients, regardless of the suspected stroke etiology, if detection of atrial fibrillation is of clinical relevance,” said Dr. Wachter, a cardiologist and professor at the University Clinic in Leipzig, Germany.

Based on 3-year follow-up of patients enrolled in the FIND-AF study, which randomized patients within 7 days of an acute ischemic stroke to either EPM for atrial fibrillation (AF) or standard work-up and follow-up, Dr. Wachter calculated that every six such patients who underwent EMP for AF yielded one added patient who could receive anticoagulant prophylaxis for 1 year, an effect that should result in fewer incident strokes and deaths. The data he reported showed after 3 years a “favorable trend” toward fewer strokes and deaths among patients who underwent EPM.

FIND-AF RANDOMISED (A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients) ran at four German centers during May 2013–August 2014. It enrolled 398 patients aged 60 years or older within 7 days of an acute ischemic stroke who were in sinus rhythm and had no AF history. Enrolled patients could have any type of suspected stroke etiology, but the study excluded patients with severe stenosis in their ipsilateral carotid or intracranial arteries. The study randomized patients to received EPM or a standard work-up. The “enhanced” part of EPM meant review of Holter monitor recordings by a single, dedicated core laboratory. The “prolonged” part meant routinely screening patients for an atrial arrhythmia using a Holter monitor worn for 10 consecutive days on three occasions: at entry into the study, 3 months later, and 6 months later.

The study’s primary endpoint was the number of patients diagnosed with AF after 6 months, which was 27 of 200 patients (13.5%) in the EPM arm and 9 of 198 patients (4.5%) in the control arm, a statistically significant difference, Dr. Wachter and his associates reported in Lancet Neurology (2017 Apr 1;16[4]:282-90).

The additional 30 months of follow-up included in the new report by Dr. Wachter resulted in identification of 3 more patients with AF in the EPM group and 13 more patients in the control arm, which brought the total number of patients with AF identified over 3 years to 30 in the EPM group (15%), and 22 in the control group (11%), a difference that was not statistically significant. In other words, both approaches found roughly the same percentage of patients with AF, but the EPM method found them quicker.

During the extended 36-month follow-up, 12 patients in the EPM group had an ischemic stroke and 9 patients died, with a combined stroke and death rate of about 8%. In the control group, 19 patients had a second ischemic stroke and 13 died, with a combined rate of about 15%. A statistical test of the difference between the combined stroke and death rates in these two groups produced a P value of .08.

FIND-AF was funded by Boehringer Ingelheim. Dr. Wachter has been a speaker on behalf of and has received research funding from Boehringer Ingelheim, and he has also been a speaker on behalf of Bayer, BMS/Pfizer, and Daiichi Sankyo.

mzoler@mdedge.com

SOURCE: Wachter R et al. World Stroke Congress, Abstract.

A group of internists is suing the American Board of Internal Medicine over its maintenance of certification. Also today, drug test results should not dictate treatment, duodenoscopes contain more bacteria than expected, and weight-loss medications may have a role following bariatric surgery.

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A group of internists is suing the American Board of Internal Medicine over its maintenance of certification. Also today, drug test results should not dictate treatment, duodenoscopes contain more bacteria than expected, and weight-loss medications may have a role following bariatric surgery.

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Apple Podcasts
Google Podcasts
Spotify
 

A group of internists is suing the American Board of Internal Medicine over its maintenance of certification. Also today, drug test results should not dictate treatment, duodenoscopes contain more bacteria than expected, and weight-loss medications may have a role following bariatric surgery.

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Apple Podcasts
Google Podcasts
Spotify
 

NEW ORLEANS – More than 30% of patients with newly diagnosed epilepsy do not initiate antiepileptic drug (AED) treatment at the time of diagnosis, according to an Australian study presented at the annual meeting of the American Epilepsy Society. Most untreated patients begin an AED after experiencing subsequent seizures, however.

“The decision to start or withhold treatment reflects the complex interplay between factors perceived to influence the predicted risk of seizure recurrence, which remain imprecise, and personal factors,” said lead study author Zhibin Chen, PhD, a biostatistician at the University of Melbourne and colleagues.

Many patients with epilepsy in resource-poor countries may not receive AED therapy for socioeconomic reasons, but little is known about untreated epilepsy in high-income countries. To assess the extent of and reasons for patients not receiving AEDs when treatment is accessible and affordable, Dr. Chen and colleagues prospectively recruited adult patients who attended the first-seizure clinics of publicly funded hospitals in Western Australia between May 1, 1999, and May 31, 2016. The patients had new-onset seizures and were referred by primary care or emergency department physicians. The health care system provided universal coverage for patients’ hospital admissions, outpatient visits, investigations, and treatment.

The researchers identified patients with newly diagnosed epilepsy and reviewed medical records to determine the proportion of untreated patients and the reasons for not starting treatment at each follow-up visit. The investigators compared the sociodemographic factors, neuroimaging, and EEG findings of treated and untreated patients.

In all, 1,317 people attended the clinics during the study period, and 610 patients (61% male; median age, 40) received a diagnosis of epilepsy and met 2014 International League Against Epilepsy (ILAE) diagnostic criteria for epilepsy. Patients were followed for a median of 5.7 years.

Of the 610 patients with epilepsy, 31% did not start AED treatment at the time of diagnosis – 16.4% because the neurologist did not recommend treatment and 14.6% because the patient declined treatment despite a neurologist’s recommendation to start therapy.

Patients’ reasons for not starting treatment included doubts about the need for treatment or about the epilepsy diagnosis, as well as concerns about medication side effects. Neurologists’ reasons for not beginning treatment included a patient having only one seizure and awaiting further results. The presence of seizure-precipitating factors (e.g., flashing lights, sleep deprivation, stress, or alcohol use) was another reason that patients and neurologists commonly cited for not initiating treatment.

Among the 189 initially untreated patients, 62.4% started treatment after a median delay of 95 days, “mainly after further seizures,” the investigators said. Patients with epilepsy who were older, from lower socioeconomic areas, had experienced more seizures, or had epileptogenic lesions on neuroimaging were more likely to initiate AED treatment at diagnosis.

“The percentage of people who were not initially prescribed AEDs was much higher than expected and suggests that untreated epilepsy exists not just in resource-poor, but also in wealthy countries,” said Dr. Chen.

More research is needed to assess the long-term outcomes of patient with seizure-precipitating factors who initiate AEDs immediately, compared with those who try avoidance of precipitating factors alone, said Dr. Chen.

This study was supported by a grant from UCB Pharma.

jremaly@mdedge.com

SOURCE: Chen Z et al. AES 2018, Abstract 3.421.

NEW ORLEANS – More than 30% of patients with newly diagnosed epilepsy do not initiate antiepileptic drug (AED) treatment at the time of diagnosis, according to an Australian study presented at the annual meeting of the American Epilepsy Society. Most untreated patients begin an AED after experiencing subsequent seizures, however.

“The decision to start or withhold treatment reflects the complex interplay between factors perceived to influence the predicted risk of seizure recurrence, which remain imprecise, and personal factors,” said lead study author Zhibin Chen, PhD, a biostatistician at the University of Melbourne and colleagues.

Many patients with epilepsy in resource-poor countries may not receive AED therapy for socioeconomic reasons, but little is known about untreated epilepsy in high-income countries. To assess the extent of and reasons for patients not receiving AEDs when treatment is accessible and affordable, Dr. Chen and colleagues prospectively recruited adult patients who attended the first-seizure clinics of publicly funded hospitals in Western Australia between May 1, 1999, and May 31, 2016. The patients had new-onset seizures and were referred by primary care or emergency department physicians. The health care system provided universal coverage for patients’ hospital admissions, outpatient visits, investigations, and treatment.

The researchers identified patients with newly diagnosed epilepsy and reviewed medical records to determine the proportion of untreated patients and the reasons for not starting treatment at each follow-up visit. The investigators compared the sociodemographic factors, neuroimaging, and EEG findings of treated and untreated patients.

In all, 1,317 people attended the clinics during the study period, and 610 patients (61% male; median age, 40) received a diagnosis of epilepsy and met 2014 International League Against Epilepsy (ILAE) diagnostic criteria for epilepsy. Patients were followed for a median of 5.7 years.

Of the 610 patients with epilepsy, 31% did not start AED treatment at the time of diagnosis – 16.4% because the neurologist did not recommend treatment and 14.6% because the patient declined treatment despite a neurologist’s recommendation to start therapy.

Patients’ reasons for not starting treatment included doubts about the need for treatment or about the epilepsy diagnosis, as well as concerns about medication side effects. Neurologists’ reasons for not beginning treatment included a patient having only one seizure and awaiting further results. The presence of seizure-precipitating factors (e.g., flashing lights, sleep deprivation, stress, or alcohol use) was another reason that patients and neurologists commonly cited for not initiating treatment.

Among the 189 initially untreated patients, 62.4% started treatment after a median delay of 95 days, “mainly after further seizures,” the investigators said. Patients with epilepsy who were older, from lower socioeconomic areas, had experienced more seizures, or had epileptogenic lesions on neuroimaging were more likely to initiate AED treatment at diagnosis.

“The percentage of people who were not initially prescribed AEDs was much higher than expected and suggests that untreated epilepsy exists not just in resource-poor, but also in wealthy countries,” said Dr. Chen.

More research is needed to assess the long-term outcomes of patient with seizure-precipitating factors who initiate AEDs immediately, compared with those who try avoidance of precipitating factors alone, said Dr. Chen.

This study was supported by a grant from UCB Pharma.

jremaly@mdedge.com

SOURCE: Chen Z et al. AES 2018, Abstract 3.421.

NEW ORLEANS – More than 30% of patients with newly diagnosed epilepsy do not initiate antiepileptic drug (AED) treatment at the time of diagnosis, according to an Australian study presented at the annual meeting of the American Epilepsy Society. Most untreated patients begin an AED after experiencing subsequent seizures, however.

“The decision to start or withhold treatment reflects the complex interplay between factors perceived to influence the predicted risk of seizure recurrence, which remain imprecise, and personal factors,” said lead study author Zhibin Chen, PhD, a biostatistician at the University of Melbourne and colleagues.

Many patients with epilepsy in resource-poor countries may not receive AED therapy for socioeconomic reasons, but little is known about untreated epilepsy in high-income countries. To assess the extent of and reasons for patients not receiving AEDs when treatment is accessible and affordable, Dr. Chen and colleagues prospectively recruited adult patients who attended the first-seizure clinics of publicly funded hospitals in Western Australia between May 1, 1999, and May 31, 2016. The patients had new-onset seizures and were referred by primary care or emergency department physicians. The health care system provided universal coverage for patients’ hospital admissions, outpatient visits, investigations, and treatment.

The researchers identified patients with newly diagnosed epilepsy and reviewed medical records to determine the proportion of untreated patients and the reasons for not starting treatment at each follow-up visit. The investigators compared the sociodemographic factors, neuroimaging, and EEG findings of treated and untreated patients.

In all, 1,317 people attended the clinics during the study period, and 610 patients (61% male; median age, 40) received a diagnosis of epilepsy and met 2014 International League Against Epilepsy (ILAE) diagnostic criteria for epilepsy. Patients were followed for a median of 5.7 years.

Of the 610 patients with epilepsy, 31% did not start AED treatment at the time of diagnosis – 16.4% because the neurologist did not recommend treatment and 14.6% because the patient declined treatment despite a neurologist’s recommendation to start therapy.

Patients’ reasons for not starting treatment included doubts about the need for treatment or about the epilepsy diagnosis, as well as concerns about medication side effects. Neurologists’ reasons for not beginning treatment included a patient having only one seizure and awaiting further results. The presence of seizure-precipitating factors (e.g., flashing lights, sleep deprivation, stress, or alcohol use) was another reason that patients and neurologists commonly cited for not initiating treatment.

Among the 189 initially untreated patients, 62.4% started treatment after a median delay of 95 days, “mainly after further seizures,” the investigators said. Patients with epilepsy who were older, from lower socioeconomic areas, had experienced more seizures, or had epileptogenic lesions on neuroimaging were more likely to initiate AED treatment at diagnosis.

“The percentage of people who were not initially prescribed AEDs was much higher than expected and suggests that untreated epilepsy exists not just in resource-poor, but also in wealthy countries,” said Dr. Chen.

More research is needed to assess the long-term outcomes of patient with seizure-precipitating factors who initiate AEDs immediately, compared with those who try avoidance of precipitating factors alone, said Dr. Chen.

This study was supported by a grant from UCB Pharma.

jremaly@mdedge.com

SOURCE: Chen Z et al. AES 2018, Abstract 3.421.

Nabiximols, a cannabis-based oral spray containing delta-9 tetrahydrocannabinol and cannabidiol, significantly improved spasticity symptoms in combination with antispasticity drugs in patients with motor neuron disease in a randomized, double-blind, placebo-controlled, parallel-group, phase 2 clinical trial.

Nabiximols proved superior to a placebo spray when both were given to patients with either amyotrophic lateral sclerosis or primary lateral sclerosis as part of an antispasticity regimen in the 6-week, CANALS (Cannabis Sativa Extract in Amyotrophic Lateral Sclerosis and other Motor Neuron Disease) study at four Italian centers, Nilo Riva, MD, PhD, of the San Raffaele Scientific Institute in Milan and his colleagues reported in The Lancet Neurology. Nabiximols is approved for the treatment of spasticity due to multiple sclerosis in multiple countries, but not in the United States.

“There is no cure for motor neuron disease, so improved symptom control and quality of life are important for patients,” Dr. Riva stated in a press release. “Our proof-of-concept trial showed a beneficial effect of THC-CBD [delta-9 tetrahydrocannabinol and cannabidiol] spray in people on treatment-resistant spasticity and pain.

“Despite these encouraging findings, we must first confirm that THC-CBD spray is effective and safe in larger, longer-term phase 3 trials,” Dr. Riva added.

The patients enrolled in the phase 2 trial between January 2013 and December 2014 and were between 18 and 80 years old with a probable diagnosis of amyotrophic lateral sclerosis or primary lateral sclerosis, were on an antispasticity regimen for at least 30 days, and had a spasticity score of at least 1 in two muscle groups on the 5-point Modified Ashworth Scale. Participants titrated for the first 2 weeks before maintaining their treatment for 4 weeks.

Of 59 participants at final follow-up, Modified Ashworth Scale scores improved in the nabiximols group (29 participants) by a mean of –0.11 points, compared with worsening by a mean of 0.16 points in the placebo group (30 participants). The researchers noted that there were no participants who withdrew from the study, nabiximols was well-tolerated, and there were no serious adverse events in the nabiximols group; however, there were 22 participants in the nabiximols group and 8 participants in the placebo group who experienced an adverse event from any cause.

“This study is, to our knowledge, the first randomized controlled trial of safety and efficacy of a pharmacological treatment for spasticity and the first trial of nabiximols in motor neuron disease,” Dr. Riva and his colleagues wrote. “Our results suggest that the study drug is well tolerated and provides first evidence of efficacy in terms of controlling spasticity in patients with motor neuron disease.”

The study was funded by the Italian Research Foundation for Amyotrophic Lateral Sclerosis. GW Pharma, which developed nabiximols, provided the study drug and placebo. Many of the authors reported financial disclosures with pharmaceutical companies.

SOURCE: Riva N et al. Lancet Neurol. 2018 Dec 13. doi: 10.1016/S1474-4422(18)30406-X.

Nabiximols, a cannabis-based oral spray containing delta-9 tetrahydrocannabinol and cannabidiol, significantly improved spasticity symptoms in combination with antispasticity drugs in patients with motor neuron disease in a randomized, double-blind, placebo-controlled, parallel-group, phase 2 clinical trial.

Nabiximols proved superior to a placebo spray when both were given to patients with either amyotrophic lateral sclerosis or primary lateral sclerosis as part of an antispasticity regimen in the 6-week, CANALS (Cannabis Sativa Extract in Amyotrophic Lateral Sclerosis and other Motor Neuron Disease) study at four Italian centers, Nilo Riva, MD, PhD, of the San Raffaele Scientific Institute in Milan and his colleagues reported in The Lancet Neurology. Nabiximols is approved for the treatment of spasticity due to multiple sclerosis in multiple countries, but not in the United States.

“There is no cure for motor neuron disease, so improved symptom control and quality of life are important for patients,” Dr. Riva stated in a press release. “Our proof-of-concept trial showed a beneficial effect of THC-CBD [delta-9 tetrahydrocannabinol and cannabidiol] spray in people on treatment-resistant spasticity and pain.

“Despite these encouraging findings, we must first confirm that THC-CBD spray is effective and safe in larger, longer-term phase 3 trials,” Dr. Riva added.

The patients enrolled in the phase 2 trial between January 2013 and December 2014 and were between 18 and 80 years old with a probable diagnosis of amyotrophic lateral sclerosis or primary lateral sclerosis, were on an antispasticity regimen for at least 30 days, and had a spasticity score of at least 1 in two muscle groups on the 5-point Modified Ashworth Scale. Participants titrated for the first 2 weeks before maintaining their treatment for 4 weeks.

Of 59 participants at final follow-up, Modified Ashworth Scale scores improved in the nabiximols group (29 participants) by a mean of –0.11 points, compared with worsening by a mean of 0.16 points in the placebo group (30 participants). The researchers noted that there were no participants who withdrew from the study, nabiximols was well-tolerated, and there were no serious adverse events in the nabiximols group; however, there were 22 participants in the nabiximols group and 8 participants in the placebo group who experienced an adverse event from any cause.

“This study is, to our knowledge, the first randomized controlled trial of safety and efficacy of a pharmacological treatment for spasticity and the first trial of nabiximols in motor neuron disease,” Dr. Riva and his colleagues wrote. “Our results suggest that the study drug is well tolerated and provides first evidence of efficacy in terms of controlling spasticity in patients with motor neuron disease.”

The study was funded by the Italian Research Foundation for Amyotrophic Lateral Sclerosis. GW Pharma, which developed nabiximols, provided the study drug and placebo. Many of the authors reported financial disclosures with pharmaceutical companies.

SOURCE: Riva N et al. Lancet Neurol. 2018 Dec 13. doi: 10.1016/S1474-4422(18)30406-X.

Nabiximols, a cannabis-based oral spray containing delta-9 tetrahydrocannabinol and cannabidiol, significantly improved spasticity symptoms in combination with antispasticity drugs in patients with motor neuron disease in a randomized, double-blind, placebo-controlled, parallel-group, phase 2 clinical trial.

Nabiximols proved superior to a placebo spray when both were given to patients with either amyotrophic lateral sclerosis or primary lateral sclerosis as part of an antispasticity regimen in the 6-week, CANALS (Cannabis Sativa Extract in Amyotrophic Lateral Sclerosis and other Motor Neuron Disease) study at four Italian centers, Nilo Riva, MD, PhD, of the San Raffaele Scientific Institute in Milan and his colleagues reported in The Lancet Neurology. Nabiximols is approved for the treatment of spasticity due to multiple sclerosis in multiple countries, but not in the United States.

“There is no cure for motor neuron disease, so improved symptom control and quality of life are important for patients,” Dr. Riva stated in a press release. “Our proof-of-concept trial showed a beneficial effect of THC-CBD [delta-9 tetrahydrocannabinol and cannabidiol] spray in people on treatment-resistant spasticity and pain.

“Despite these encouraging findings, we must first confirm that THC-CBD spray is effective and safe in larger, longer-term phase 3 trials,” Dr. Riva added.

The patients enrolled in the phase 2 trial between January 2013 and December 2014 and were between 18 and 80 years old with a probable diagnosis of amyotrophic lateral sclerosis or primary lateral sclerosis, were on an antispasticity regimen for at least 30 days, and had a spasticity score of at least 1 in two muscle groups on the 5-point Modified Ashworth Scale. Participants titrated for the first 2 weeks before maintaining their treatment for 4 weeks.

Of 59 participants at final follow-up, Modified Ashworth Scale scores improved in the nabiximols group (29 participants) by a mean of –0.11 points, compared with worsening by a mean of 0.16 points in the placebo group (30 participants). The researchers noted that there were no participants who withdrew from the study, nabiximols was well-tolerated, and there were no serious adverse events in the nabiximols group; however, there were 22 participants in the nabiximols group and 8 participants in the placebo group who experienced an adverse event from any cause.

“This study is, to our knowledge, the first randomized controlled trial of safety and efficacy of a pharmacological treatment for spasticity and the first trial of nabiximols in motor neuron disease,” Dr. Riva and his colleagues wrote. “Our results suggest that the study drug is well tolerated and provides first evidence of efficacy in terms of controlling spasticity in patients with motor neuron disease.”

The study was funded by the Italian Research Foundation for Amyotrophic Lateral Sclerosis. GW Pharma, which developed nabiximols, provided the study drug and placebo. Many of the authors reported financial disclosures with pharmaceutical companies.

SOURCE: Riva N et al. Lancet Neurol. 2018 Dec 13. doi: 10.1016/S1474-4422(18)30406-X.

Carol Bernstein, MD, joins Nick Andrews once again this week to talk about physician burnout and physician suicide.

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Carol Bernstein, MD, joins Nick Andrews once again this week to talk about physician burnout and physician suicide.

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Carol Bernstein, MD, joins Nick Andrews once again this week to talk about physician burnout and physician suicide.

Apple Podcasts
Google Podcasts
 

Only 15% of U.S. physician practices report using telemedicine for patient care. Also today, you ought to be judicious with empiric antibiotics for febrile neutropenia, home-based exercise is better than supervised treadmill exercise for peripheral arterial disease, and brain injury in sickle cell merits more attention.
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Only 15% of U.S. physician practices report using telemedicine for patient care. Also today, you ought to be judicious with empiric antibiotics for febrile neutropenia, home-based exercise is better than supervised treadmill exercise for peripheral arterial disease, and brain injury in sickle cell merits more attention.
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Only 15% of U.S. physician practices report using telemedicine for patient care. Also today, you ought to be judicious with empiric antibiotics for febrile neutropenia, home-based exercise is better than supervised treadmill exercise for peripheral arterial disease, and brain injury in sickle cell merits more attention.
Amazon Alexa
Apple Podcasts
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Spotify