Compared with adults who underwent off-pump coronary-artery bypass grafting surgery, those who underwent on-pump CABG had significantly lower rates of mortality and major adverse cardiovascular events at 5 years, results from a large randomized trial demonstrated.

“Given the results, it appears that innovative surgical approaches – such as the more technically demanding off-pump procedure – may not always provide superior clinical outcomes,” researchers led by A. Laurie Shroyer, PhD, wrote (N Engl J Med. 2017 Aug 17;377:623-32). “Additional long-term follow-up, evaluating these same outcomes rigorously at 10 years after CABG, appears to be warranted. Future research may identify the risk factors of the patients and the cardiac surgical processes of care that affect longer-term outcomes of coronary revascularization procedures, with the goal of increasing the rate of long-term event-free survival.”

Dr. Shroyer, of the Northport (N.Y.) VA Medical Center, and her associates conduced a 5-year follow-up study of patients who had participated in the original Randomized On/Off Bypass (ROOBY) trial, which compared the effectiveness of the two surgical approaches (N Engl J Med 2009 Nov 5;361:1827-37). During February 2002–June 2007, 2,203 patients at 18 medical centers were randomly assigned to either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The primary outcomes were the rates mortality and major adverse cardiovascular events at 5 years, while the secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction.

The mean age of patients was 63 years, nearly all were male, 46% were between the ages of 55 and 64, and about 21% had chronic obstructive pulmonary disease. The researchers found that at 5 years, the rate of death was 15.2% in the off-pump group, compared with 11.9% in the on-pump group, which translated into a relative risk of 1.28 (P = .02). In addition, the rate of major cardiovascular events at 5 years was 31% in the off-pump group, compared with 27.1% in the on-pump group, which translated into a relative risk of 1.14 (P = .046). None of the secondary outcomes at 5 years met the prespecified threshold of a P value of .01 or less for statistical significance, when the off-pump and on-pump groups were compared. This included the rates of nonfatal myocardial infarction (12.1% vs. 9.6%, respectively; P = .05); death from cardiac causes (6.3% vs. 5.3%; P = .29); repeat vascularization (13.1% vs. 11.9%; P = .39), and repeat CABG (1.4% vs. 0.5%; P = .02).

“In combination with findings from other randomized trials and a 2012 Cochrane systematic review [Cochrane Database Syst Rev. 2012;14:CD007224], the 5-year outcomes in our study support the conclusion that off-pump CABG does not offer any substantial advantages over on-pump CABG except possibly in unusual situations such as, for example, in patients with an extensively calcified (porcelain) aorta, in whom the off-pump technique may result in less manipulation of the aorta, potentially decreasing the risk of aortic emboli or stroke,” the researchers wrote. “In light of the low rates of use of off-pump CABG in the United States, the findings in our trial may provide more of a real-world experience than those in the CORONARY and GOPCABE trials, which required surgeons with a very high volume of experience with off-pump procedures, as compared with the ROOBY trial and with most other surgeons who are based in the United States.”

They acknowledged certain limitations of the study, including the fact that the study population comprised mostly males who had multiple coexisting conditions, “so the findings may not be applicable to female patients or to patients who are not veterans.”

The study was supported by a grant from the Department of Veterans Affairs. Dr. Shroyer reported having received grants from the VA Cooperative Studies Program during the conduct of the study. Her coauthors reported having no financial disclosures.

[email protected]

Compared with adults who underwent off-pump coronary-artery bypass grafting surgery, those who underwent on-pump CABG had significantly lower rates of mortality and major adverse cardiovascular events at 5 years, results from a large randomized trial demonstrated.

“Given the results, it appears that innovative surgical approaches – such as the more technically demanding off-pump procedure – may not always provide superior clinical outcomes,” researchers led by A. Laurie Shroyer, PhD, wrote (N Engl J Med. 2017 Aug 17;377:623-32). “Additional long-term follow-up, evaluating these same outcomes rigorously at 10 years after CABG, appears to be warranted. Future research may identify the risk factors of the patients and the cardiac surgical processes of care that affect longer-term outcomes of coronary revascularization procedures, with the goal of increasing the rate of long-term event-free survival.”

Dr. Shroyer, of the Northport (N.Y.) VA Medical Center, and her associates conduced a 5-year follow-up study of patients who had participated in the original Randomized On/Off Bypass (ROOBY) trial, which compared the effectiveness of the two surgical approaches (N Engl J Med 2009 Nov 5;361:1827-37). During February 2002–June 2007, 2,203 patients at 18 medical centers were randomly assigned to either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The primary outcomes were the rates mortality and major adverse cardiovascular events at 5 years, while the secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction.

The mean age of patients was 63 years, nearly all were male, 46% were between the ages of 55 and 64, and about 21% had chronic obstructive pulmonary disease. The researchers found that at 5 years, the rate of death was 15.2% in the off-pump group, compared with 11.9% in the on-pump group, which translated into a relative risk of 1.28 (P = .02). In addition, the rate of major cardiovascular events at 5 years was 31% in the off-pump group, compared with 27.1% in the on-pump group, which translated into a relative risk of 1.14 (P = .046). None of the secondary outcomes at 5 years met the prespecified threshold of a P value of .01 or less for statistical significance, when the off-pump and on-pump groups were compared. This included the rates of nonfatal myocardial infarction (12.1% vs. 9.6%, respectively; P = .05); death from cardiac causes (6.3% vs. 5.3%; P = .29); repeat vascularization (13.1% vs. 11.9%; P = .39), and repeat CABG (1.4% vs. 0.5%; P = .02).

“In combination with findings from other randomized trials and a 2012 Cochrane systematic review [Cochrane Database Syst Rev. 2012;14:CD007224], the 5-year outcomes in our study support the conclusion that off-pump CABG does not offer any substantial advantages over on-pump CABG except possibly in unusual situations such as, for example, in patients with an extensively calcified (porcelain) aorta, in whom the off-pump technique may result in less manipulation of the aorta, potentially decreasing the risk of aortic emboli or stroke,” the researchers wrote. “In light of the low rates of use of off-pump CABG in the United States, the findings in our trial may provide more of a real-world experience than those in the CORONARY and GOPCABE trials, which required surgeons with a very high volume of experience with off-pump procedures, as compared with the ROOBY trial and with most other surgeons who are based in the United States.”

They acknowledged certain limitations of the study, including the fact that the study population comprised mostly males who had multiple coexisting conditions, “so the findings may not be applicable to female patients or to patients who are not veterans.”

The study was supported by a grant from the Department of Veterans Affairs. Dr. Shroyer reported having received grants from the VA Cooperative Studies Program during the conduct of the study. Her coauthors reported having no financial disclosures.

[email protected]

Compared with adults who underwent off-pump coronary-artery bypass grafting surgery, those who underwent on-pump CABG had significantly lower rates of mortality and major adverse cardiovascular events at 5 years, results from a large randomized trial demonstrated.

“Given the results, it appears that innovative surgical approaches – such as the more technically demanding off-pump procedure – may not always provide superior clinical outcomes,” researchers led by A. Laurie Shroyer, PhD, wrote (N Engl J Med. 2017 Aug 17;377:623-32). “Additional long-term follow-up, evaluating these same outcomes rigorously at 10 years after CABG, appears to be warranted. Future research may identify the risk factors of the patients and the cardiac surgical processes of care that affect longer-term outcomes of coronary revascularization procedures, with the goal of increasing the rate of long-term event-free survival.”

Dr. Shroyer, of the Northport (N.Y.) VA Medical Center, and her associates conduced a 5-year follow-up study of patients who had participated in the original Randomized On/Off Bypass (ROOBY) trial, which compared the effectiveness of the two surgical approaches (N Engl J Med 2009 Nov 5;361:1827-37). During February 2002–June 2007, 2,203 patients at 18 medical centers were randomly assigned to either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The primary outcomes were the rates mortality and major adverse cardiovascular events at 5 years, while the secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction.

The mean age of patients was 63 years, nearly all were male, 46% were between the ages of 55 and 64, and about 21% had chronic obstructive pulmonary disease. The researchers found that at 5 years, the rate of death was 15.2% in the off-pump group, compared with 11.9% in the on-pump group, which translated into a relative risk of 1.28 (P = .02). In addition, the rate of major cardiovascular events at 5 years was 31% in the off-pump group, compared with 27.1% in the on-pump group, which translated into a relative risk of 1.14 (P = .046). None of the secondary outcomes at 5 years met the prespecified threshold of a P value of .01 or less for statistical significance, when the off-pump and on-pump groups were compared. This included the rates of nonfatal myocardial infarction (12.1% vs. 9.6%, respectively; P = .05); death from cardiac causes (6.3% vs. 5.3%; P = .29); repeat vascularization (13.1% vs. 11.9%; P = .39), and repeat CABG (1.4% vs. 0.5%; P = .02).

“In combination with findings from other randomized trials and a 2012 Cochrane systematic review [Cochrane Database Syst Rev. 2012;14:CD007224], the 5-year outcomes in our study support the conclusion that off-pump CABG does not offer any substantial advantages over on-pump CABG except possibly in unusual situations such as, for example, in patients with an extensively calcified (porcelain) aorta, in whom the off-pump technique may result in less manipulation of the aorta, potentially decreasing the risk of aortic emboli or stroke,” the researchers wrote. “In light of the low rates of use of off-pump CABG in the United States, the findings in our trial may provide more of a real-world experience than those in the CORONARY and GOPCABE trials, which required surgeons with a very high volume of experience with off-pump procedures, as compared with the ROOBY trial and with most other surgeons who are based in the United States.”

They acknowledged certain limitations of the study, including the fact that the study population comprised mostly males who had multiple coexisting conditions, “so the findings may not be applicable to female patients or to patients who are not veterans.”

The study was supported by a grant from the Department of Veterans Affairs. Dr. Shroyer reported having received grants from the VA Cooperative Studies Program during the conduct of the study. Her coauthors reported having no financial disclosures.

[email protected]

A new study finds tele-neurology visits are just as effective as in-person visits for patients with Parkinson’s disease, while also saving time and mileage.

Lead author Christopher A. Beck, PhD, of the University of Rochester (N.Y.), and his colleagues studied 195 patients for 1 year who were either provided with their usual medical care or their usual medical care supplemented by four virtual visits via video conferencing from a remote specialist. Investigators evaluated the feasibility of telemedicine visits, as measured by the proportion of patients who completed at least one virtual visit and the proportion of virtual visits completed on time. Efficacy was also evaluated, as measured by the change in the Parkinson’s Disease Questionnaire–39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings.

Eligible participants had a clinical diagnosis of Parkinson’s disease, had a private, Internet-enabled device, and lived in a state where a site investigator was licensed to practice. Patients randomized to the telemedicine group received up to four virtual visits over 12 months from a neurologist. Physicians and patients determined the specific content and frequency of each visit, but the format generally included a medical history, a Parkinson’s disease–specific examination (including assessment of tremor and gait), physician recommendations, and time to address patients’ concerns (Neurology. 2017 Aug 16. doi: 10.1212/WNL.0000000000004357).

The study findings showed that the virtual house calls were as effective as were in-person visits, with quality of life no better or worse for patients receiving care at home than for those receiving care in the office. Of telemedicine patients, 98% completed at least one virtual visit, and 91% of all virtual visits scheduled were completed. Researchers also found that participants’ overall quality of care and the burden felt by caregivers was no different whether they had virtual or in-person visits. Each virtual house call saved patients a median of 88 minutes and 38 miles per visit.

Ninety-seven percent of patients and 86% of participating neurologists said they were satisfied with the virtual visits, with 55% of patients stating they preferred virtual visits over in-person visits.

The study – the first national randomized controlled trial of telemedicine to connect remote specialists to patients at home – shows that tele-neurology is a practical and effective model of care for Parkinson patients, said study coauthor E. Ray Dorsey, MD, of the University of Rochester.

“People were very interested in taking part in this study, and the results showed that these virtual house calls were feasible for people with Parkinson’s disease,” Dr. Dorsey said in a statement. “People’s care was as effective as with the in-office visits, and the virtual house calls provided the participants with convenience and comfort.”

Dr. Dorsey noted that 73% of the study participants had visited a Parkinson’s disease specialist in the past year and 83% said they were satisfied with their care, which may have impacted the quality of life finding.

“The fact that adding the virtual house calls to people’s care did not improve their quality of life could be because a large proportion were already seeing a specialist and were satisfied with that care,” he said. “Of course, it’s also possible that virtual house calls are not enough to improve quality of life.”

Limitations of the study included that study participants were primarily well-educated and more familiar with the Internet than was the general population, so results may not be relevant for all people with Parkinson’s disease. In addition, the study population, of whom 96% were white with a mean age of 66 years, did not include people with the disease who live in nursing homes, who account for nearly 25% of all Medicare beneficiaries with Parkinson’s disease.

The study was supported by the Patient-Centered Outcomes Research Institute. Dr. Dorsey serves on the medical advisory board of, and has stock options in, Grand Rounds. No other relevant disclosures relevant were reported by study authors.

[email protected]

On Twitter @legal_med

A new study finds tele-neurology visits are just as effective as in-person visits for patients with Parkinson’s disease, while also saving time and mileage.

Lead author Christopher A. Beck, PhD, of the University of Rochester (N.Y.), and his colleagues studied 195 patients for 1 year who were either provided with their usual medical care or their usual medical care supplemented by four virtual visits via video conferencing from a remote specialist. Investigators evaluated the feasibility of telemedicine visits, as measured by the proportion of patients who completed at least one virtual visit and the proportion of virtual visits completed on time. Efficacy was also evaluated, as measured by the change in the Parkinson’s Disease Questionnaire–39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings.

Eligible participants had a clinical diagnosis of Parkinson’s disease, had a private, Internet-enabled device, and lived in a state where a site investigator was licensed to practice. Patients randomized to the telemedicine group received up to four virtual visits over 12 months from a neurologist. Physicians and patients determined the specific content and frequency of each visit, but the format generally included a medical history, a Parkinson’s disease–specific examination (including assessment of tremor and gait), physician recommendations, and time to address patients’ concerns (Neurology. 2017 Aug 16. doi: 10.1212/WNL.0000000000004357).

The study findings showed that the virtual house calls were as effective as were in-person visits, with quality of life no better or worse for patients receiving care at home than for those receiving care in the office. Of telemedicine patients, 98% completed at least one virtual visit, and 91% of all virtual visits scheduled were completed. Researchers also found that participants’ overall quality of care and the burden felt by caregivers was no different whether they had virtual or in-person visits. Each virtual house call saved patients a median of 88 minutes and 38 miles per visit.

Ninety-seven percent of patients and 86% of participating neurologists said they were satisfied with the virtual visits, with 55% of patients stating they preferred virtual visits over in-person visits.

The study – the first national randomized controlled trial of telemedicine to connect remote specialists to patients at home – shows that tele-neurology is a practical and effective model of care for Parkinson patients, said study coauthor E. Ray Dorsey, MD, of the University of Rochester.

“People were very interested in taking part in this study, and the results showed that these virtual house calls were feasible for people with Parkinson’s disease,” Dr. Dorsey said in a statement. “People’s care was as effective as with the in-office visits, and the virtual house calls provided the participants with convenience and comfort.”

Dr. Dorsey noted that 73% of the study participants had visited a Parkinson’s disease specialist in the past year and 83% said they were satisfied with their care, which may have impacted the quality of life finding.

“The fact that adding the virtual house calls to people’s care did not improve their quality of life could be because a large proportion were already seeing a specialist and were satisfied with that care,” he said. “Of course, it’s also possible that virtual house calls are not enough to improve quality of life.”

Limitations of the study included that study participants were primarily well-educated and more familiar with the Internet than was the general population, so results may not be relevant for all people with Parkinson’s disease. In addition, the study population, of whom 96% were white with a mean age of 66 years, did not include people with the disease who live in nursing homes, who account for nearly 25% of all Medicare beneficiaries with Parkinson’s disease.

The study was supported by the Patient-Centered Outcomes Research Institute. Dr. Dorsey serves on the medical advisory board of, and has stock options in, Grand Rounds. No other relevant disclosures relevant were reported by study authors.

[email protected]

On Twitter @legal_med

A new study finds tele-neurology visits are just as effective as in-person visits for patients with Parkinson’s disease, while also saving time and mileage.

Lead author Christopher A. Beck, PhD, of the University of Rochester (N.Y.), and his colleagues studied 195 patients for 1 year who were either provided with their usual medical care or their usual medical care supplemented by four virtual visits via video conferencing from a remote specialist. Investigators evaluated the feasibility of telemedicine visits, as measured by the proportion of patients who completed at least one virtual visit and the proportion of virtual visits completed on time. Efficacy was also evaluated, as measured by the change in the Parkinson’s Disease Questionnaire–39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings.

Eligible participants had a clinical diagnosis of Parkinson’s disease, had a private, Internet-enabled device, and lived in a state where a site investigator was licensed to practice. Patients randomized to the telemedicine group received up to four virtual visits over 12 months from a neurologist. Physicians and patients determined the specific content and frequency of each visit, but the format generally included a medical history, a Parkinson’s disease–specific examination (including assessment of tremor and gait), physician recommendations, and time to address patients’ concerns (Neurology. 2017 Aug 16. doi: 10.1212/WNL.0000000000004357).

The study findings showed that the virtual house calls were as effective as were in-person visits, with quality of life no better or worse for patients receiving care at home than for those receiving care in the office. Of telemedicine patients, 98% completed at least one virtual visit, and 91% of all virtual visits scheduled were completed. Researchers also found that participants’ overall quality of care and the burden felt by caregivers was no different whether they had virtual or in-person visits. Each virtual house call saved patients a median of 88 minutes and 38 miles per visit.

Ninety-seven percent of patients and 86% of participating neurologists said they were satisfied with the virtual visits, with 55% of patients stating they preferred virtual visits over in-person visits.

The study – the first national randomized controlled trial of telemedicine to connect remote specialists to patients at home – shows that tele-neurology is a practical and effective model of care for Parkinson patients, said study coauthor E. Ray Dorsey, MD, of the University of Rochester.

“People were very interested in taking part in this study, and the results showed that these virtual house calls were feasible for people with Parkinson’s disease,” Dr. Dorsey said in a statement. “People’s care was as effective as with the in-office visits, and the virtual house calls provided the participants with convenience and comfort.”

Dr. Dorsey noted that 73% of the study participants had visited a Parkinson’s disease specialist in the past year and 83% said they were satisfied with their care, which may have impacted the quality of life finding.

“The fact that adding the virtual house calls to people’s care did not improve their quality of life could be because a large proportion were already seeing a specialist and were satisfied with that care,” he said. “Of course, it’s also possible that virtual house calls are not enough to improve quality of life.”

Limitations of the study included that study participants were primarily well-educated and more familiar with the Internet than was the general population, so results may not be relevant for all people with Parkinson’s disease. In addition, the study population, of whom 96% were white with a mean age of 66 years, did not include people with the disease who live in nursing homes, who account for nearly 25% of all Medicare beneficiaries with Parkinson’s disease.

The study was supported by the Patient-Centered Outcomes Research Institute. Dr. Dorsey serves on the medical advisory board of, and has stock options in, Grand Rounds. No other relevant disclosures relevant were reported by study authors.

[email protected]

On Twitter @legal_med

Mutations in SCN1A, SCN2A, and SCN8A, which code for neuronal voltage-gated sodium channel alpha-subunits, have been associated with certain early onset epilepsy syndromes.  Despite this association, many clinicians are uncertain about the value of missense genetic variants in the management of epilepsy because many mutations are classified as having unknown significance. A recent database analysis identified gene variants that are pathogenic and benign, giving clinicians a better understanding of how to interpret SCN test results. Details of the investigation include the following:

• Investigators used 8 algorithms to evaluate the pathogenicity of various genetic variants. They also used logistic regression to help determine if combining algorithms might improve their ability to predict pathogenicity.
• 440 variants were considered pathogenic or likely pathogenic.
• Most computer algorithms that attempt to determine the value of SCN test results are very sensitive but also suffer from low specificity.
• The Mendelian Clinically Applicable Pathogenicity algorithm proved most valuable, with an accuracy of 0.90.

Holland KD, Bouley TM, Horn PS. Comparison and optimization of in silico algorithms for predicting the pathogenicity of sodium channel variants in epilepsy. Epilepsia. 2017;58(7):1190-1198.

Mutations in SCN1A, SCN2A, and SCN8A, which code for neuronal voltage-gated sodium channel alpha-subunits, have been associated with certain early onset epilepsy syndromes.  Despite this association, many clinicians are uncertain about the value of missense genetic variants in the management of epilepsy because many mutations are classified as having unknown significance. A recent database analysis identified gene variants that are pathogenic and benign, giving clinicians a better understanding of how to interpret SCN test results. Details of the investigation include the following:

• Investigators used 8 algorithms to evaluate the pathogenicity of various genetic variants. They also used logistic regression to help determine if combining algorithms might improve their ability to predict pathogenicity.
• 440 variants were considered pathogenic or likely pathogenic.
• Most computer algorithms that attempt to determine the value of SCN test results are very sensitive but also suffer from low specificity.
• The Mendelian Clinically Applicable Pathogenicity algorithm proved most valuable, with an accuracy of 0.90.

Holland KD, Bouley TM, Horn PS. Comparison and optimization of in silico algorithms for predicting the pathogenicity of sodium channel variants in epilepsy. Epilepsia. 2017;58(7):1190-1198.

Mutations in SCN1A, SCN2A, and SCN8A, which code for neuronal voltage-gated sodium channel alpha-subunits, have been associated with certain early onset epilepsy syndromes.  Despite this association, many clinicians are uncertain about the value of missense genetic variants in the management of epilepsy because many mutations are classified as having unknown significance. A recent database analysis identified gene variants that are pathogenic and benign, giving clinicians a better understanding of how to interpret SCN test results. Details of the investigation include the following:

• Investigators used 8 algorithms to evaluate the pathogenicity of various genetic variants. They also used logistic regression to help determine if combining algorithms might improve their ability to predict pathogenicity.
• 440 variants were considered pathogenic or likely pathogenic.
• Most computer algorithms that attempt to determine the value of SCN test results are very sensitive but also suffer from low specificity.
• The Mendelian Clinically Applicable Pathogenicity algorithm proved most valuable, with an accuracy of 0.90.

Holland KD, Bouley TM, Horn PS. Comparison and optimization of in silico algorithms for predicting the pathogenicity of sodium channel variants in epilepsy. Epilepsia. 2017;58(7):1190-1198.

Siblings tend to have a similar response to antiepileptic drugs (AEDs) suggests a study that compared drug response in sibling pairs. Details of the investigation include the following:

• Investigators collected records from a single-center database that included patients with a diagnosis of epilepsy in which their last names, addresses, and parents’ names were matched to determine the existence of siblings with the same disease.
• Twenty-eight sibling pairs were identified, along with 2 sibling trios with epilepsy.
• Seventeen of the sibling pairs had been taking the same initial AED, while 15 pairs had the same type of epilepsy.

• When at least one sibling in a pair improved on an initial AED, the other sibling was more likely to respond if they were taking the same AED compared with those who were taking a different AED.
• While a positive response to an AED predicted success in a sibling taking the same drug, investigators pointed out that their study was retrospective and involved a small sample, which is why they recommended larger prospective trials.

Ueda K, Serajee F, Rajilich J, Taraman S, Steckling L, Huq AM. Sibling response to initial antiepileptic medication predicts treatment success. Epilepsy Res. 2017;136:84-87.

Siblings tend to have a similar response to antiepileptic drugs (AEDs) suggests a study that compared drug response in sibling pairs. Details of the investigation include the following:

• Investigators collected records from a single-center database that included patients with a diagnosis of epilepsy in which their last names, addresses, and parents’ names were matched to determine the existence of siblings with the same disease.
• Twenty-eight sibling pairs were identified, along with 2 sibling trios with epilepsy.
• Seventeen of the sibling pairs had been taking the same initial AED, while 15 pairs had the same type of epilepsy.

• When at least one sibling in a pair improved on an initial AED, the other sibling was more likely to respond if they were taking the same AED compared with those who were taking a different AED.
• While a positive response to an AED predicted success in a sibling taking the same drug, investigators pointed out that their study was retrospective and involved a small sample, which is why they recommended larger prospective trials.

Ueda K, Serajee F, Rajilich J, Taraman S, Steckling L, Huq AM. Sibling response to initial antiepileptic medication predicts treatment success. Epilepsy Res. 2017;136:84-87.

Siblings tend to have a similar response to antiepileptic drugs (AEDs) suggests a study that compared drug response in sibling pairs. Details of the investigation include the following:

• Investigators collected records from a single-center database that included patients with a diagnosis of epilepsy in which their last names, addresses, and parents’ names were matched to determine the existence of siblings with the same disease.
• Twenty-eight sibling pairs were identified, along with 2 sibling trios with epilepsy.
• Seventeen of the sibling pairs had been taking the same initial AED, while 15 pairs had the same type of epilepsy.

• When at least one sibling in a pair improved on an initial AED, the other sibling was more likely to respond if they were taking the same AED compared with those who were taking a different AED.
• While a positive response to an AED predicted success in a sibling taking the same drug, investigators pointed out that their study was retrospective and involved a small sample, which is why they recommended larger prospective trials.

Ueda K, Serajee F, Rajilich J, Taraman S, Steckling L, Huq AM. Sibling response to initial antiepileptic medication predicts treatment success. Epilepsy Res. 2017;136:84-87.

Identifying a seizure propagation network in patients who have undergone surgery for unilateral temporal lobe epilepsy (TLE) may help determine which patients are most likely to remain seizure free over time, according to an analysis of patients who underwent magnetic resonance imaging (MRI) scans. Details of the investigation include the following:

• MRI of 22 unilateral TLE patients found functional connectivity that encompassed the ipsilateral (to seizure focus) and contralateral hippocampus, thalamus, and insula. 35 healthy individuals were included in the study to act as controls.
• Resting state functional and diffusion-weighted 3T magnetic resonance imaging was used in the study.
• The investigators discovered a consistent connectivity pattern representing the network expected in patients who remained seizure free. This was found in 8 patients who did not have seizures one year after surgery.
• Using this model, they were able to differentiate patients with unfavorable outcomes from those with long-term freedom from seizures.

This study provides evidence that network connectivity could be a clinical tool for epilepsy surgery outcome prediction.

Morgan VL, Englot DJ, Rogers BP, et al. Magnetic resonance imaging connectivity for the prediction of seizure outcome in temporal lobe epilepsy. Epilepsia. 2017;58(7):1251-1260.

Identifying a seizure propagation network in patients who have undergone surgery for unilateral temporal lobe epilepsy (TLE) may help determine which patients are most likely to remain seizure free over time, according to an analysis of patients who underwent magnetic resonance imaging (MRI) scans. Details of the investigation include the following:

• MRI of 22 unilateral TLE patients found functional connectivity that encompassed the ipsilateral (to seizure focus) and contralateral hippocampus, thalamus, and insula. 35 healthy individuals were included in the study to act as controls.
• Resting state functional and diffusion-weighted 3T magnetic resonance imaging was used in the study.
• The investigators discovered a consistent connectivity pattern representing the network expected in patients who remained seizure free. This was found in 8 patients who did not have seizures one year after surgery.
• Using this model, they were able to differentiate patients with unfavorable outcomes from those with long-term freedom from seizures.

This study provides evidence that network connectivity could be a clinical tool for epilepsy surgery outcome prediction.

Morgan VL, Englot DJ, Rogers BP, et al. Magnetic resonance imaging connectivity for the prediction of seizure outcome in temporal lobe epilepsy. Epilepsia. 2017;58(7):1251-1260.

Identifying a seizure propagation network in patients who have undergone surgery for unilateral temporal lobe epilepsy (TLE) may help determine which patients are most likely to remain seizure free over time, according to an analysis of patients who underwent magnetic resonance imaging (MRI) scans. Details of the investigation include the following:

• MRI of 22 unilateral TLE patients found functional connectivity that encompassed the ipsilateral (to seizure focus) and contralateral hippocampus, thalamus, and insula. 35 healthy individuals were included in the study to act as controls.
• Resting state functional and diffusion-weighted 3T magnetic resonance imaging was used in the study.
• The investigators discovered a consistent connectivity pattern representing the network expected in patients who remained seizure free. This was found in 8 patients who did not have seizures one year after surgery.
• Using this model, they were able to differentiate patients with unfavorable outcomes from those with long-term freedom from seizures.

This study provides evidence that network connectivity could be a clinical tool for epilepsy surgery outcome prediction.

Morgan VL, Englot DJ, Rogers BP, et al. Magnetic resonance imaging connectivity for the prediction of seizure outcome in temporal lobe epilepsy. Epilepsia. 2017;58(7):1251-1260.

For quite some time now, I’ve been urging my colleagues to follow the science on the powerful impact of choline on the brain.

In May 2017, based on studies using genetically altered mice that show the developmental changes of Down syndrome and Alzheimer’s disease at 6 months, I raised the question of whether prenatal choline could lead to the prevention of Alzheimer’s.

Antonio_Diaz/Thinkstock

*This story was updated August 17, 2017.

For quite some time now, I’ve been urging my colleagues to follow the science on the powerful impact of choline on the brain.

In May 2017, based on studies using genetically altered mice that show the developmental changes of Down syndrome and Alzheimer’s disease at 6 months, I raised the question of whether prenatal choline could lead to the prevention of Alzheimer’s.

Antonio_Diaz/Thinkstock

*This story was updated August 17, 2017.

For quite some time now, I’ve been urging my colleagues to follow the science on the powerful impact of choline on the brain.

In May 2017, based on studies using genetically altered mice that show the developmental changes of Down syndrome and Alzheimer’s disease at 6 months, I raised the question of whether prenatal choline could lead to the prevention of Alzheimer’s.

Antonio_Diaz/Thinkstock

*This story was updated August 17, 2017.

The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.

The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.

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The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.

The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.

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The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.

The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.

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ESTES PARK, COLO. – Now that the opioid epidemic has formally been declared a national emergency, physicians can expect to encounter growing pressure to taper opioids in their chronic pain patients, Sunny Linnebur, PharmD, predicted at a conference on internal medicine sponsored by the University of Colorado.

As an example of what physicians around the country might expect, she added, Colorado state health officials recently announced that coverage of opioid therapy for Medicaid patients will be reduced. State health officials recommended that physicians taper down their patients’ opioids.

Fortunately, helpful tools for doing so are just a few mouse clicks away, according to Dr. Linnebur, professor of clinical pharmacy at the University of Colorado, Aurora.

Indications for opioid tapering as described in a guide provided by the Centers for Disease Control and Prevention include lack of a sustained or clinically meaningful improvement in pain and functioning as defined, for example, by at least a 30% improvement on the three-item PEG scale; use of opioids at a daily dosage of 50 morphine equivalent doses or more without evidence of benefit; signs of a substance use disorder other than tobacco dependence; warning signs of harms, such as drowsiness, slurred speech, or difficulty controlling use of the medication; patient request; and any situation where the physician deems that the benefits no longer outweigh the risks (www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf).

General principles of tapering opioids as outlined by the CDC include reducing the dosage by about 10% a week at a time – although if a patient has been on opioids for years, then at a slower rate, perhaps 10% per month, may be more appropriate. If a patient has been using a 12.5 mcg/hour fentanyl patch, a switch to an oral opioid is recommended to complete the taper. When the smallest dosage has been reached, the interval between doses can be stretched; and once the medication is being taken less than once per day, it can be stopped.

Bruce Jancin/Frontline Medical News

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ESTES PARK, COLO. – Now that the opioid epidemic has formally been declared a national emergency, physicians can expect to encounter growing pressure to taper opioids in their chronic pain patients, Sunny Linnebur, PharmD, predicted at a conference on internal medicine sponsored by the University of Colorado.

As an example of what physicians around the country might expect, she added, Colorado state health officials recently announced that coverage of opioid therapy for Medicaid patients will be reduced. State health officials recommended that physicians taper down their patients’ opioids.

Fortunately, helpful tools for doing so are just a few mouse clicks away, according to Dr. Linnebur, professor of clinical pharmacy at the University of Colorado, Aurora.

Indications for opioid tapering as described in a guide provided by the Centers for Disease Control and Prevention include lack of a sustained or clinically meaningful improvement in pain and functioning as defined, for example, by at least a 30% improvement on the three-item PEG scale; use of opioids at a daily dosage of 50 morphine equivalent doses or more without evidence of benefit; signs of a substance use disorder other than tobacco dependence; warning signs of harms, such as drowsiness, slurred speech, or difficulty controlling use of the medication; patient request; and any situation where the physician deems that the benefits no longer outweigh the risks (www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf).

General principles of tapering opioids as outlined by the CDC include reducing the dosage by about 10% a week at a time – although if a patient has been on opioids for years, then at a slower rate, perhaps 10% per month, may be more appropriate. If a patient has been using a 12.5 mcg/hour fentanyl patch, a switch to an oral opioid is recommended to complete the taper. When the smallest dosage has been reached, the interval between doses can be stretched; and once the medication is being taken less than once per day, it can be stopped.

Bruce Jancin/Frontline Medical News

[email protected]

ESTES PARK, COLO. – Now that the opioid epidemic has formally been declared a national emergency, physicians can expect to encounter growing pressure to taper opioids in their chronic pain patients, Sunny Linnebur, PharmD, predicted at a conference on internal medicine sponsored by the University of Colorado.

As an example of what physicians around the country might expect, she added, Colorado state health officials recently announced that coverage of opioid therapy for Medicaid patients will be reduced. State health officials recommended that physicians taper down their patients’ opioids.

Fortunately, helpful tools for doing so are just a few mouse clicks away, according to Dr. Linnebur, professor of clinical pharmacy at the University of Colorado, Aurora.

Indications for opioid tapering as described in a guide provided by the Centers for Disease Control and Prevention include lack of a sustained or clinically meaningful improvement in pain and functioning as defined, for example, by at least a 30% improvement on the three-item PEG scale; use of opioids at a daily dosage of 50 morphine equivalent doses or more without evidence of benefit; signs of a substance use disorder other than tobacco dependence; warning signs of harms, such as drowsiness, slurred speech, or difficulty controlling use of the medication; patient request; and any situation where the physician deems that the benefits no longer outweigh the risks (www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf).

General principles of tapering opioids as outlined by the CDC include reducing the dosage by about 10% a week at a time – although if a patient has been on opioids for years, then at a slower rate, perhaps 10% per month, may be more appropriate. If a patient has been using a 12.5 mcg/hour fentanyl patch, a switch to an oral opioid is recommended to complete the taper. When the smallest dosage has been reached, the interval between doses can be stretched; and once the medication is being taken less than once per day, it can be stopped.

Bruce Jancin/Frontline Medical News

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The Oncologic Drugs Advisory Committee to the Food and Drug Administration will meet on Sept. 19 to discuss a supplemental new drug application for sunitinib (Sutent), for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.

Sunitinib is an oral antiangiogenic agent that has been approved for the treatment of advanced RCC since 2006.

The FDA accepted the new drug application in May and is expected to issue a decision by January 2018.

The advisory committee will consider comments from the public if submitted by Sept. 5, as electronic comments through the electronic filing system or by mail/hand delivery/courier at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The docket number is FDA-2017-N-1063.

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The Oncologic Drugs Advisory Committee to the Food and Drug Administration will meet on Sept. 19 to discuss a supplemental new drug application for sunitinib (Sutent), for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.

Sunitinib is an oral antiangiogenic agent that has been approved for the treatment of advanced RCC since 2006.

The FDA accepted the new drug application in May and is expected to issue a decision by January 2018.

The advisory committee will consider comments from the public if submitted by Sept. 5, as electronic comments through the electronic filing system or by mail/hand delivery/courier at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The docket number is FDA-2017-N-1063.

[email protected]

The Oncologic Drugs Advisory Committee to the Food and Drug Administration will meet on Sept. 19 to discuss a supplemental new drug application for sunitinib (Sutent), for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.

Sunitinib is an oral antiangiogenic agent that has been approved for the treatment of advanced RCC since 2006.

The FDA accepted the new drug application in May and is expected to issue a decision by January 2018.

The advisory committee will consider comments from the public if submitted by Sept. 5, as electronic comments through the electronic filing system or by mail/hand delivery/courier at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The docket number is FDA-2017-N-1063.

[email protected]

SAN FRANCISCO– The role of fidaxomicin for treating mild to moderate Clostridium difficile infection is still finding its way, according to Sarah Doernberg, MD.

For now, fidaxomicin, a narrow spectrum macrocyclic antibiotic, may be appropriate for those at high risk for relapse and/or those requiring concomitant antibiotics – but its high price tag may be prohibitive.

“I think a lot of centers have taken the fidaxomicin data, which were based on patients with initial infection or a single relapse, and extrapolated it to patients with multiple relapses,” Dr. Doernberg, medical director of adult antimicrobial stewardship at UCSF Medical Center, said at the UCSF Annual Advances in Internal Medicine meeting.

In a recent analysis, researchers collected real-world data on implementation of fidaxomicin for CDI patients at seven hospitals in the United Kingdom (Eur J Clin Microbiol Infect Dis. 2016 Feb;35[2]:251-9). In two hospitals where fidaxomicin was used as the first-line treatment for all primary and recurrent episodes, the recurrence rate reduced from 10.6% to 3.1% and from 16.3% to 3.1%, with a significant difference in 28-day mortality, from 18.2% to 3.1%; (P less than .05) and 17.3% to 6.3% (P less than .05). In the remaining five hospitals that used fidaxomicin in selected patients only, the changes in recurrence rates and mortality were less marked.

Other studies have found that fidaxomicin has a similar cure rate, compared with vancomycin (around 88%) but a lower recurrence rate (13%-15%, compared with 25%-27%, respectively; see N Engl J Med. 2011 Feb 3;364[5]:422-31). However, the general cost for a course is significantly more, compared with metronidazole and vancomycin, making fidaxomicin less cost effective as a first-line agent in most cases (Clin Infect Dis. 2013 Aug 15; 57[4]:555-61).

“Our guidelines recommend it in patients who have a very high risk for relapse who would not be candidates for fecal transplant down the line, which generally means immunocompromised patients,” Dr. Doernberg said.

Additional considerations when treating CDI include stopping unnecessary antibiotics, shortening the antibiotic course, narrowing the antibiotic spectrum, and stopping acid-suppressive medication when possible, especially proton pump inhibitors. “Do no use anti-peristaltic agents until acute symptoms of CDI improve,” she said.

Dr. Doernberg disclosed that she is a consultant for Actelion. She has also conducted prior research studies with Cerexa, Cubist, and Merck.

[email protected]

SAN FRANCISCO– The role of fidaxomicin for treating mild to moderate Clostridium difficile infection is still finding its way, according to Sarah Doernberg, MD.

For now, fidaxomicin, a narrow spectrum macrocyclic antibiotic, may be appropriate for those at high risk for relapse and/or those requiring concomitant antibiotics – but its high price tag may be prohibitive.

“I think a lot of centers have taken the fidaxomicin data, which were based on patients with initial infection or a single relapse, and extrapolated it to patients with multiple relapses,” Dr. Doernberg, medical director of adult antimicrobial stewardship at UCSF Medical Center, said at the UCSF Annual Advances in Internal Medicine meeting.

In a recent analysis, researchers collected real-world data on implementation of fidaxomicin for CDI patients at seven hospitals in the United Kingdom (Eur J Clin Microbiol Infect Dis. 2016 Feb;35[2]:251-9). In two hospitals where fidaxomicin was used as the first-line treatment for all primary and recurrent episodes, the recurrence rate reduced from 10.6% to 3.1% and from 16.3% to 3.1%, with a significant difference in 28-day mortality, from 18.2% to 3.1%; (P less than .05) and 17.3% to 6.3% (P less than .05). In the remaining five hospitals that used fidaxomicin in selected patients only, the changes in recurrence rates and mortality were less marked.

Other studies have found that fidaxomicin has a similar cure rate, compared with vancomycin (around 88%) but a lower recurrence rate (13%-15%, compared with 25%-27%, respectively; see N Engl J Med. 2011 Feb 3;364[5]:422-31). However, the general cost for a course is significantly more, compared with metronidazole and vancomycin, making fidaxomicin less cost effective as a first-line agent in most cases (Clin Infect Dis. 2013 Aug 15; 57[4]:555-61).

“Our guidelines recommend it in patients who have a very high risk for relapse who would not be candidates for fecal transplant down the line, which generally means immunocompromised patients,” Dr. Doernberg said.

Additional considerations when treating CDI include stopping unnecessary antibiotics, shortening the antibiotic course, narrowing the antibiotic spectrum, and stopping acid-suppressive medication when possible, especially proton pump inhibitors. “Do no use anti-peristaltic agents until acute symptoms of CDI improve,” she said.

Dr. Doernberg disclosed that she is a consultant for Actelion. She has also conducted prior research studies with Cerexa, Cubist, and Merck.

[email protected]

SAN FRANCISCO– The role of fidaxomicin for treating mild to moderate Clostridium difficile infection is still finding its way, according to Sarah Doernberg, MD.

For now, fidaxomicin, a narrow spectrum macrocyclic antibiotic, may be appropriate for those at high risk for relapse and/or those requiring concomitant antibiotics – but its high price tag may be prohibitive.

“I think a lot of centers have taken the fidaxomicin data, which were based on patients with initial infection or a single relapse, and extrapolated it to patients with multiple relapses,” Dr. Doernberg, medical director of adult antimicrobial stewardship at UCSF Medical Center, said at the UCSF Annual Advances in Internal Medicine meeting.

In a recent analysis, researchers collected real-world data on implementation of fidaxomicin for CDI patients at seven hospitals in the United Kingdom (Eur J Clin Microbiol Infect Dis. 2016 Feb;35[2]:251-9). In two hospitals where fidaxomicin was used as the first-line treatment for all primary and recurrent episodes, the recurrence rate reduced from 10.6% to 3.1% and from 16.3% to 3.1%, with a significant difference in 28-day mortality, from 18.2% to 3.1%; (P less than .05) and 17.3% to 6.3% (P less than .05). In the remaining five hospitals that used fidaxomicin in selected patients only, the changes in recurrence rates and mortality were less marked.

Other studies have found that fidaxomicin has a similar cure rate, compared with vancomycin (around 88%) but a lower recurrence rate (13%-15%, compared with 25%-27%, respectively; see N Engl J Med. 2011 Feb 3;364[5]:422-31). However, the general cost for a course is significantly more, compared with metronidazole and vancomycin, making fidaxomicin less cost effective as a first-line agent in most cases (Clin Infect Dis. 2013 Aug 15; 57[4]:555-61).

“Our guidelines recommend it in patients who have a very high risk for relapse who would not be candidates for fecal transplant down the line, which generally means immunocompromised patients,” Dr. Doernberg said.

Additional considerations when treating CDI include stopping unnecessary antibiotics, shortening the antibiotic course, narrowing the antibiotic spectrum, and stopping acid-suppressive medication when possible, especially proton pump inhibitors. “Do no use anti-peristaltic agents until acute symptoms of CDI improve,” she said.

Dr. Doernberg disclosed that she is a consultant for Actelion. She has also conducted prior research studies with Cerexa, Cubist, and Merck.

[email protected]