User login
IGRA preferred test for latent TB diagnosis
TORONTO – U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.
Adam G. Green, MD, conducted the research while he was a fellow in pulmonology/critical care at Montefiore Medical Center in New York. Dr. Green told attendees that about one-third of the world’s population are infected with TB and about 15 million of those live in the United States. Two-thirds of U.S. cases are seen in foreign-born individuals and are clustered in four states—New, York, California, Florida, and Texas.
Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.
While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.
Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.
Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”
Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.
One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.
To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.
“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”
The authors reported there were no product or funding disclosures relevant to this study.
TORONTO – U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.
Adam G. Green, MD, conducted the research while he was a fellow in pulmonology/critical care at Montefiore Medical Center in New York. Dr. Green told attendees that about one-third of the world’s population are infected with TB and about 15 million of those live in the United States. Two-thirds of U.S. cases are seen in foreign-born individuals and are clustered in four states—New, York, California, Florida, and Texas.
Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.
While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.
Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.
Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”
Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.
One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.
To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.
“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”
The authors reported there were no product or funding disclosures relevant to this study.
TORONTO – U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.
Adam G. Green, MD, conducted the research while he was a fellow in pulmonology/critical care at Montefiore Medical Center in New York. Dr. Green told attendees that about one-third of the world’s population are infected with TB and about 15 million of those live in the United States. Two-thirds of U.S. cases are seen in foreign-born individuals and are clustered in four states—New, York, California, Florida, and Texas.
Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.
While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.
Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.
Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”
Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.
One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.
To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.
“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”
The authors reported there were no product or funding disclosures relevant to this study.
AT CHEST 2017
Key clinical point: Most physicians queried preferred IGRAs over TST for the detection of latent TB infection.
Major finding: Of the 304 respondents to a survey, 78% said they preferred IGRAs over TST for TB testing and 91% reported having a good understanding of how to use and interpret IGRAs.
Data source: Online survey of 304 pulmonary and infectious disease attending physicians and fellows from U.S.-based academic programs.
Disclosures: The authors reported there were no product or funding disclosures relevant to this study.
Strict OR attire policy had no impact on SSI rate
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Implementation of stringent operating room attire policies do not reduce rates superficial surgical site infections (SSIs).
Major finding: The researchers observed no significant differences preimplementation and postimplementation of OR attire policies in the rates of incisional SSI (0.97 vs. 0.96, respectively; P = .949), organ space SSI (1.20 vs 0.81; P = .115), and total SSIs (2.11 vs. 1.77; P = .321).
Study details: A study of 6,517 patients who underwent surgery at two tertiary care teaching hospitals.
Disclosures: The researchers reported having no financial disclosures.
New and Noteworthy Information—November 2017
Can a Fatty Diet Increase Relapse Risk in Children With MS?
In children with multiple sclerosis (MS), high energy intake from fat, especially saturated fat, may increase the hazard of relapse, while vegetable intake may be independently protective, according to a study published online ahead of print October 9 in the Journal of Neurology, Neurosurgery & Psychiatry. A total of 219 patients with pediatric relapsing-remitting MS or clinically isolated syndrome with disease onset before age 18 and duration of less than four years were enrolled in a multicenter study that was completed at 11 pediatric MS centers. Investigators used the Block Kids Food Screener to examine dietary intake during the week before enrollment. Each 10% increase in energy intake from fat increased the hazard of relapse by 56%, and each 10% increase in saturated fat tripled this hazard.
Azary S, Schreiner T, Graves J, et al. Contribution of dietary intake to relapse rate in early paediatric multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Oct 9 [Epub ahead of print].
Cooling Reduces Risk of Epilepsy After Perinatal Asphyxia
Administering therapeutic hypothermia to babies with perinatal asphyxia can reduce their risk of epilepsy in childhood, according to a study published online ahead of print September 29 in Epilepsia. From 2006 to 2013, 151 infants with perinatal asphyxia underwent 72 hours of cooling. Clinical and amplitude-integrated EEG with single-channel EEG-verified neonatal seizures were treated with antiepileptic drugs (AEDs). MRI was assessed using a severity score that ranged from 0 to 11. One hundred thirty-four children were assessed at 18–24 months. Babies born after 2007 who received therapeutic hypothermia had a lower rate of epilepsy than those born before this method was introduced. At two years, 6% of the children had epilepsy, and 2% were receiving AEDs. Before therapeutic hypothermia was introduced, the rate of death or moderate or severe disability was about 66%.
Liu X, Jary S, Cowan F, Thoresen M. Reduced infancy and childhood epilepsy following hypothermia-treated neonatal encephalopathy. Epilepsia. 2017 Sep 29 [Epub ahead of print].
Risk Factors Are Increasing in People With Stroke
The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse in acute ischemic stroke increased between 2004 and 2014, according to a study published online ahead of print October 11 in Neurology. Researchers used the National Inpatient Sample to identify 922,451 adult hospitalizations for ischemic stroke. In all, 92.5% of patients with stroke had one or more risk factors. Age- and sex-adjusted prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse were 79%, 34%, 47%, 15%, and 2%, respectively. The prevalence of carotid stenosis, chronic renal failure, and coronary artery disease were 13%, 12%, and 27%, respectively. Risk factor prevalence varied by age, race, and sex. The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse increased annually by 1.4%, 2%, 7%, 5%, and 7%, respectively.
Otite FO, Liaw N, Khandelwal P, et al. Increasing prevalence of vascular risk factors in patients with stroke: a call to action. Neurology. 2017 Oct 11 [Epub ahead of print].
Transcranial Direct-Current Stimulation for MS-Related Fatigue
People with multiple sclerosis (MS) who undergo a noninvasive form of electrical brain stimulation have significantly reduced fatigue, according to a study published online ahead of print September 1 in the Multiple Sclerosis Journal. Twenty-seven people with MS were randomized to receive transcranial direct-current stimulation or a placebo while playing a cognitive training game that targets processing speed and working memory. After 20 sessions, participants reported their level of fatigue using the Patient-Reported Outcomes Measurement Information System. Higher numbers correlated with greater fatigue. The researchers reported a statistically significant reduction in the group that underwent transcranial direct-current stimulation, compared with the placebo group. Intervention participants had a 5.6-point drop in fatigue on average, while control participants had a 0.9-point increase in fatigue.
Charvet LE, Dobbs B, Shaw MT, et al. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: results from a randomized, sham-controlled trial. Mult Scler. 2017 Sep 1 [Epub ahead of print].
New Genetic Risk Variants for RLS Identified
Thirteen previously unknown genetic risk variants for restless legs syndrome (RLS) have been identified, according to a study published in the November issue of Lancet Neurology. Researchers combined three genome-wide association studies’ datasets with diagnosis data collected from 2003 to 2017. The latter data came from interviews and questionnaires and included 15,126 cases and 95,725 controls. Significant genome-wide signals were tested for replication in an independent genome-wide association study of 30,770 cases and 286,913 controls. Investigators identified and replicated 13 new risk loci for RLS and confirmed six previously identified risk loci. MEIS1 was confirmed as the strongest genetic risk factor for RLS. Gene prioritization, enrichment, and genetic correlation analyses showed that identified pathways were related to neurodevelopment and highlighted genes linked to axon guidance, synapse formation, and neuronal specification.
Schormair B, Zhao C, Bell S, et al. Identification of novel risk loci for restless legs syndrome in genome-wide association studies in individuals of European ancestry: a meta-analysis. Lancet Neurol. 2017;16(11):898-907.
High Blood Pressure Associated With Increased Dementia Risk in Women
Hypertension is more common in men, but is only associated with dementia risk in women, according to a study published online ahead of print October 4 in Neurology. Researchers evaluated 5,646 members of a diverse integrated health care delivery system who had clinical examinations and health survey data from 1964 to 1973 (mean age, 32.7) and 1978 to 1985 (mean age, 44.3) and were members as of January 1, 1996 (mean age, 59.8). A total of 532 people were diagnosed with dementia. Mid-adulthood (circa age 44) hypertension was associated with 65% increased dementia risk among women, but not among men. Onset of hypertension in mid-adulthood predicted 73% higher dementia risk in women, compared with stable normotension. There was no evidence that hypertension or changes in hypertension increased dementia risk among men.
Gilsanz P, Mayeda ER, Glymour MM, et al. Female sex, early-onset hypertension, and risk of dementia. Neurology. 2017 Oct 4 [Epub ahead of print].
A Risk Factor for Major Bleeding During Treatment With NOACs
Among patients taking non-vitamin K oral anticoagulants (NOACs) for nonvalvular atrial fibrillation, concurrent use of amiodarone, fluconazole, rifampin, and phenytoin, compared with the use of NOACs alone, is associated with increased risk of major bleeding, according to a study published October 3 in JAMA. Researchers retrospectively examined data for 91,330 patients with nonvalvular atrial fibrillation who received at least one NOAC prescription of dabigatran, rivaroxaban, or apixaban from 2012 through 2016. They analyzed the bleeding risk associated with the concurrent use of 12 commonly prescribed medications. A total of 4,770 major bleeding events occurred. The incidence rate of major bleeding was significantly lower for concurrent use of atorvastatin, digoxin, and erythromycin or clarithromycin. Physicians prescribing NOACs should consider the potential risks associated with concomitant use of other drugs, the researchers said.
Chang SH, Chou IJ, Yeh YH, et al. Association between use of non-vitamin K oral anticoagulants with and without concurrent medications and risk of major bleeding in nonvalvular atrial fibrillation. JAMA. 2017;318(13):1250-1259.
Discontinuing Aspirin Therapy May Increase Cardiovascular Risk
In long-term users, discontinuation of low-dose aspirin in the absence of major surgery or bleeding is associated with a greater-than-30% increased risk of cardiovascular events, according to a study published September 26 in Circulation. Researchers performed a cohort study of 601,527 participants taking low-dose aspirin for heart attack and stroke prevention between 2005 and 2009. Participants were older than 40, cancer-free, and had an adherence rate of 80% or greater during the first year of treatment. During a median of 3.0 years of follow-up, 62,690 cardiovascular events were reported. Patients who discontinued aspirin had a higher rate of cardiovascular events than those who continued (multivariable-adjusted hazard ratio, 1.37), corresponding to an additional cardiovascular event observed per year in one of every 74 patients who discontinued aspirin.
Sundström J, Hedberg J, Thuresson M, et al. Low-dose aspirin discontinuation and risk of cardiovascular events: a Swedish nationwide, population-based cohort study. Circulation. 2017;136(13):1183-1192.
FDA Approves 80-mg Ingrezza Capsule for Tardive Dyskinesia
The FDA has approved an 80-mg capsule of Ingrezza (valbenazine) for the treatment of adults with tardive dyskinesia. In clinical studies, Ingrezza 80 mg provided significant, rapid, and meaningful improvement in tardive dyskinesia severity, compared with placebo, at six weeks. Results were seen as early as two weeks, and continued reductions were observed through 48 weeks of treatment. The drug was FDA-approved in April and has been available as 40-mg capsules. Neurocrine Biosciences markets Ingrezza.
FDA Approves Generic Version of Copaxone
The FDA has approved Mylan’s glatiramer acetate injection 40 mg/mL for thrice-weekly injection. The drug is a substitutable generic version of Teva’s Copaxone 40 mg/mL. The agency also approved Mylan’s glatiramer acetate injection 20 mg/mL for once-daily injection, a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both products are indicated for the treatment of patients with relapsing forms of multiple sclerosis. As part of its applications, Mylan submitted side-by-side analyses demonstrating that its glatiramer acetate injections have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart.
FDA Approves Gocovri for Dyskinesia in Parkinson’s Disease
The FDA has approved Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first medicine approved by the FDA for this indication. Gocovri is a high-dose (274 mg) formulation of amantadine (equivalent to 340 mg of amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day. Adamas Pharmaceuticals markets the drug.
FDA Has Approved Lyrica CR for Two Indications
The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. The efficacy and safety of Lyrica CR in postherpetic neuralgia was established in a randomized placebo-controlled clinical trial conducted in 801 patients with postherpetic neuralgia who entered single-blind treatment with Lyrica CR. In the study, 73.6% of patients in the Lyrica CR group achieved at least 50% improvement in pain intensity, compared with 54.6% in the placebo group. The postherpetic neuralgia data also supported the diabetic peripheral neuropathy indication. Pfizer markets Lyrica CR.
—Kimberly Williams
Can a Fatty Diet Increase Relapse Risk in Children With MS?
In children with multiple sclerosis (MS), high energy intake from fat, especially saturated fat, may increase the hazard of relapse, while vegetable intake may be independently protective, according to a study published online ahead of print October 9 in the Journal of Neurology, Neurosurgery & Psychiatry. A total of 219 patients with pediatric relapsing-remitting MS or clinically isolated syndrome with disease onset before age 18 and duration of less than four years were enrolled in a multicenter study that was completed at 11 pediatric MS centers. Investigators used the Block Kids Food Screener to examine dietary intake during the week before enrollment. Each 10% increase in energy intake from fat increased the hazard of relapse by 56%, and each 10% increase in saturated fat tripled this hazard.
Azary S, Schreiner T, Graves J, et al. Contribution of dietary intake to relapse rate in early paediatric multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Oct 9 [Epub ahead of print].
Cooling Reduces Risk of Epilepsy After Perinatal Asphyxia
Administering therapeutic hypothermia to babies with perinatal asphyxia can reduce their risk of epilepsy in childhood, according to a study published online ahead of print September 29 in Epilepsia. From 2006 to 2013, 151 infants with perinatal asphyxia underwent 72 hours of cooling. Clinical and amplitude-integrated EEG with single-channel EEG-verified neonatal seizures were treated with antiepileptic drugs (AEDs). MRI was assessed using a severity score that ranged from 0 to 11. One hundred thirty-four children were assessed at 18–24 months. Babies born after 2007 who received therapeutic hypothermia had a lower rate of epilepsy than those born before this method was introduced. At two years, 6% of the children had epilepsy, and 2% were receiving AEDs. Before therapeutic hypothermia was introduced, the rate of death or moderate or severe disability was about 66%.
Liu X, Jary S, Cowan F, Thoresen M. Reduced infancy and childhood epilepsy following hypothermia-treated neonatal encephalopathy. Epilepsia. 2017 Sep 29 [Epub ahead of print].
Risk Factors Are Increasing in People With Stroke
The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse in acute ischemic stroke increased between 2004 and 2014, according to a study published online ahead of print October 11 in Neurology. Researchers used the National Inpatient Sample to identify 922,451 adult hospitalizations for ischemic stroke. In all, 92.5% of patients with stroke had one or more risk factors. Age- and sex-adjusted prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse were 79%, 34%, 47%, 15%, and 2%, respectively. The prevalence of carotid stenosis, chronic renal failure, and coronary artery disease were 13%, 12%, and 27%, respectively. Risk factor prevalence varied by age, race, and sex. The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse increased annually by 1.4%, 2%, 7%, 5%, and 7%, respectively.
Otite FO, Liaw N, Khandelwal P, et al. Increasing prevalence of vascular risk factors in patients with stroke: a call to action. Neurology. 2017 Oct 11 [Epub ahead of print].
Transcranial Direct-Current Stimulation for MS-Related Fatigue
People with multiple sclerosis (MS) who undergo a noninvasive form of electrical brain stimulation have significantly reduced fatigue, according to a study published online ahead of print September 1 in the Multiple Sclerosis Journal. Twenty-seven people with MS were randomized to receive transcranial direct-current stimulation or a placebo while playing a cognitive training game that targets processing speed and working memory. After 20 sessions, participants reported their level of fatigue using the Patient-Reported Outcomes Measurement Information System. Higher numbers correlated with greater fatigue. The researchers reported a statistically significant reduction in the group that underwent transcranial direct-current stimulation, compared with the placebo group. Intervention participants had a 5.6-point drop in fatigue on average, while control participants had a 0.9-point increase in fatigue.
Charvet LE, Dobbs B, Shaw MT, et al. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: results from a randomized, sham-controlled trial. Mult Scler. 2017 Sep 1 [Epub ahead of print].
New Genetic Risk Variants for RLS Identified
Thirteen previously unknown genetic risk variants for restless legs syndrome (RLS) have been identified, according to a study published in the November issue of Lancet Neurology. Researchers combined three genome-wide association studies’ datasets with diagnosis data collected from 2003 to 2017. The latter data came from interviews and questionnaires and included 15,126 cases and 95,725 controls. Significant genome-wide signals were tested for replication in an independent genome-wide association study of 30,770 cases and 286,913 controls. Investigators identified and replicated 13 new risk loci for RLS and confirmed six previously identified risk loci. MEIS1 was confirmed as the strongest genetic risk factor for RLS. Gene prioritization, enrichment, and genetic correlation analyses showed that identified pathways were related to neurodevelopment and highlighted genes linked to axon guidance, synapse formation, and neuronal specification.
Schormair B, Zhao C, Bell S, et al. Identification of novel risk loci for restless legs syndrome in genome-wide association studies in individuals of European ancestry: a meta-analysis. Lancet Neurol. 2017;16(11):898-907.
High Blood Pressure Associated With Increased Dementia Risk in Women
Hypertension is more common in men, but is only associated with dementia risk in women, according to a study published online ahead of print October 4 in Neurology. Researchers evaluated 5,646 members of a diverse integrated health care delivery system who had clinical examinations and health survey data from 1964 to 1973 (mean age, 32.7) and 1978 to 1985 (mean age, 44.3) and were members as of January 1, 1996 (mean age, 59.8). A total of 532 people were diagnosed with dementia. Mid-adulthood (circa age 44) hypertension was associated with 65% increased dementia risk among women, but not among men. Onset of hypertension in mid-adulthood predicted 73% higher dementia risk in women, compared with stable normotension. There was no evidence that hypertension or changes in hypertension increased dementia risk among men.
Gilsanz P, Mayeda ER, Glymour MM, et al. Female sex, early-onset hypertension, and risk of dementia. Neurology. 2017 Oct 4 [Epub ahead of print].
A Risk Factor for Major Bleeding During Treatment With NOACs
Among patients taking non-vitamin K oral anticoagulants (NOACs) for nonvalvular atrial fibrillation, concurrent use of amiodarone, fluconazole, rifampin, and phenytoin, compared with the use of NOACs alone, is associated with increased risk of major bleeding, according to a study published October 3 in JAMA. Researchers retrospectively examined data for 91,330 patients with nonvalvular atrial fibrillation who received at least one NOAC prescription of dabigatran, rivaroxaban, or apixaban from 2012 through 2016. They analyzed the bleeding risk associated with the concurrent use of 12 commonly prescribed medications. A total of 4,770 major bleeding events occurred. The incidence rate of major bleeding was significantly lower for concurrent use of atorvastatin, digoxin, and erythromycin or clarithromycin. Physicians prescribing NOACs should consider the potential risks associated with concomitant use of other drugs, the researchers said.
Chang SH, Chou IJ, Yeh YH, et al. Association between use of non-vitamin K oral anticoagulants with and without concurrent medications and risk of major bleeding in nonvalvular atrial fibrillation. JAMA. 2017;318(13):1250-1259.
Discontinuing Aspirin Therapy May Increase Cardiovascular Risk
In long-term users, discontinuation of low-dose aspirin in the absence of major surgery or bleeding is associated with a greater-than-30% increased risk of cardiovascular events, according to a study published September 26 in Circulation. Researchers performed a cohort study of 601,527 participants taking low-dose aspirin for heart attack and stroke prevention between 2005 and 2009. Participants were older than 40, cancer-free, and had an adherence rate of 80% or greater during the first year of treatment. During a median of 3.0 years of follow-up, 62,690 cardiovascular events were reported. Patients who discontinued aspirin had a higher rate of cardiovascular events than those who continued (multivariable-adjusted hazard ratio, 1.37), corresponding to an additional cardiovascular event observed per year in one of every 74 patients who discontinued aspirin.
Sundström J, Hedberg J, Thuresson M, et al. Low-dose aspirin discontinuation and risk of cardiovascular events: a Swedish nationwide, population-based cohort study. Circulation. 2017;136(13):1183-1192.
FDA Approves 80-mg Ingrezza Capsule for Tardive Dyskinesia
The FDA has approved an 80-mg capsule of Ingrezza (valbenazine) for the treatment of adults with tardive dyskinesia. In clinical studies, Ingrezza 80 mg provided significant, rapid, and meaningful improvement in tardive dyskinesia severity, compared with placebo, at six weeks. Results were seen as early as two weeks, and continued reductions were observed through 48 weeks of treatment. The drug was FDA-approved in April and has been available as 40-mg capsules. Neurocrine Biosciences markets Ingrezza.
FDA Approves Generic Version of Copaxone
The FDA has approved Mylan’s glatiramer acetate injection 40 mg/mL for thrice-weekly injection. The drug is a substitutable generic version of Teva’s Copaxone 40 mg/mL. The agency also approved Mylan’s glatiramer acetate injection 20 mg/mL for once-daily injection, a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both products are indicated for the treatment of patients with relapsing forms of multiple sclerosis. As part of its applications, Mylan submitted side-by-side analyses demonstrating that its glatiramer acetate injections have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart.
FDA Approves Gocovri for Dyskinesia in Parkinson’s Disease
The FDA has approved Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first medicine approved by the FDA for this indication. Gocovri is a high-dose (274 mg) formulation of amantadine (equivalent to 340 mg of amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day. Adamas Pharmaceuticals markets the drug.
FDA Has Approved Lyrica CR for Two Indications
The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. The efficacy and safety of Lyrica CR in postherpetic neuralgia was established in a randomized placebo-controlled clinical trial conducted in 801 patients with postherpetic neuralgia who entered single-blind treatment with Lyrica CR. In the study, 73.6% of patients in the Lyrica CR group achieved at least 50% improvement in pain intensity, compared with 54.6% in the placebo group. The postherpetic neuralgia data also supported the diabetic peripheral neuropathy indication. Pfizer markets Lyrica CR.
—Kimberly Williams
Can a Fatty Diet Increase Relapse Risk in Children With MS?
In children with multiple sclerosis (MS), high energy intake from fat, especially saturated fat, may increase the hazard of relapse, while vegetable intake may be independently protective, according to a study published online ahead of print October 9 in the Journal of Neurology, Neurosurgery & Psychiatry. A total of 219 patients with pediatric relapsing-remitting MS or clinically isolated syndrome with disease onset before age 18 and duration of less than four years were enrolled in a multicenter study that was completed at 11 pediatric MS centers. Investigators used the Block Kids Food Screener to examine dietary intake during the week before enrollment. Each 10% increase in energy intake from fat increased the hazard of relapse by 56%, and each 10% increase in saturated fat tripled this hazard.
Azary S, Schreiner T, Graves J, et al. Contribution of dietary intake to relapse rate in early paediatric multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Oct 9 [Epub ahead of print].
Cooling Reduces Risk of Epilepsy After Perinatal Asphyxia
Administering therapeutic hypothermia to babies with perinatal asphyxia can reduce their risk of epilepsy in childhood, according to a study published online ahead of print September 29 in Epilepsia. From 2006 to 2013, 151 infants with perinatal asphyxia underwent 72 hours of cooling. Clinical and amplitude-integrated EEG with single-channel EEG-verified neonatal seizures were treated with antiepileptic drugs (AEDs). MRI was assessed using a severity score that ranged from 0 to 11. One hundred thirty-four children were assessed at 18–24 months. Babies born after 2007 who received therapeutic hypothermia had a lower rate of epilepsy than those born before this method was introduced. At two years, 6% of the children had epilepsy, and 2% were receiving AEDs. Before therapeutic hypothermia was introduced, the rate of death or moderate or severe disability was about 66%.
Liu X, Jary S, Cowan F, Thoresen M. Reduced infancy and childhood epilepsy following hypothermia-treated neonatal encephalopathy. Epilepsia. 2017 Sep 29 [Epub ahead of print].
Risk Factors Are Increasing in People With Stroke
The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse in acute ischemic stroke increased between 2004 and 2014, according to a study published online ahead of print October 11 in Neurology. Researchers used the National Inpatient Sample to identify 922,451 adult hospitalizations for ischemic stroke. In all, 92.5% of patients with stroke had one or more risk factors. Age- and sex-adjusted prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse were 79%, 34%, 47%, 15%, and 2%, respectively. The prevalence of carotid stenosis, chronic renal failure, and coronary artery disease were 13%, 12%, and 27%, respectively. Risk factor prevalence varied by age, race, and sex. The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse increased annually by 1.4%, 2%, 7%, 5%, and 7%, respectively.
Otite FO, Liaw N, Khandelwal P, et al. Increasing prevalence of vascular risk factors in patients with stroke: a call to action. Neurology. 2017 Oct 11 [Epub ahead of print].
Transcranial Direct-Current Stimulation for MS-Related Fatigue
People with multiple sclerosis (MS) who undergo a noninvasive form of electrical brain stimulation have significantly reduced fatigue, according to a study published online ahead of print September 1 in the Multiple Sclerosis Journal. Twenty-seven people with MS were randomized to receive transcranial direct-current stimulation or a placebo while playing a cognitive training game that targets processing speed and working memory. After 20 sessions, participants reported their level of fatigue using the Patient-Reported Outcomes Measurement Information System. Higher numbers correlated with greater fatigue. The researchers reported a statistically significant reduction in the group that underwent transcranial direct-current stimulation, compared with the placebo group. Intervention participants had a 5.6-point drop in fatigue on average, while control participants had a 0.9-point increase in fatigue.
Charvet LE, Dobbs B, Shaw MT, et al. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: results from a randomized, sham-controlled trial. Mult Scler. 2017 Sep 1 [Epub ahead of print].
New Genetic Risk Variants for RLS Identified
Thirteen previously unknown genetic risk variants for restless legs syndrome (RLS) have been identified, according to a study published in the November issue of Lancet Neurology. Researchers combined three genome-wide association studies’ datasets with diagnosis data collected from 2003 to 2017. The latter data came from interviews and questionnaires and included 15,126 cases and 95,725 controls. Significant genome-wide signals were tested for replication in an independent genome-wide association study of 30,770 cases and 286,913 controls. Investigators identified and replicated 13 new risk loci for RLS and confirmed six previously identified risk loci. MEIS1 was confirmed as the strongest genetic risk factor for RLS. Gene prioritization, enrichment, and genetic correlation analyses showed that identified pathways were related to neurodevelopment and highlighted genes linked to axon guidance, synapse formation, and neuronal specification.
Schormair B, Zhao C, Bell S, et al. Identification of novel risk loci for restless legs syndrome in genome-wide association studies in individuals of European ancestry: a meta-analysis. Lancet Neurol. 2017;16(11):898-907.
High Blood Pressure Associated With Increased Dementia Risk in Women
Hypertension is more common in men, but is only associated with dementia risk in women, according to a study published online ahead of print October 4 in Neurology. Researchers evaluated 5,646 members of a diverse integrated health care delivery system who had clinical examinations and health survey data from 1964 to 1973 (mean age, 32.7) and 1978 to 1985 (mean age, 44.3) and were members as of January 1, 1996 (mean age, 59.8). A total of 532 people were diagnosed with dementia. Mid-adulthood (circa age 44) hypertension was associated with 65% increased dementia risk among women, but not among men. Onset of hypertension in mid-adulthood predicted 73% higher dementia risk in women, compared with stable normotension. There was no evidence that hypertension or changes in hypertension increased dementia risk among men.
Gilsanz P, Mayeda ER, Glymour MM, et al. Female sex, early-onset hypertension, and risk of dementia. Neurology. 2017 Oct 4 [Epub ahead of print].
A Risk Factor for Major Bleeding During Treatment With NOACs
Among patients taking non-vitamin K oral anticoagulants (NOACs) for nonvalvular atrial fibrillation, concurrent use of amiodarone, fluconazole, rifampin, and phenytoin, compared with the use of NOACs alone, is associated with increased risk of major bleeding, according to a study published October 3 in JAMA. Researchers retrospectively examined data for 91,330 patients with nonvalvular atrial fibrillation who received at least one NOAC prescription of dabigatran, rivaroxaban, or apixaban from 2012 through 2016. They analyzed the bleeding risk associated with the concurrent use of 12 commonly prescribed medications. A total of 4,770 major bleeding events occurred. The incidence rate of major bleeding was significantly lower for concurrent use of atorvastatin, digoxin, and erythromycin or clarithromycin. Physicians prescribing NOACs should consider the potential risks associated with concomitant use of other drugs, the researchers said.
Chang SH, Chou IJ, Yeh YH, et al. Association between use of non-vitamin K oral anticoagulants with and without concurrent medications and risk of major bleeding in nonvalvular atrial fibrillation. JAMA. 2017;318(13):1250-1259.
Discontinuing Aspirin Therapy May Increase Cardiovascular Risk
In long-term users, discontinuation of low-dose aspirin in the absence of major surgery or bleeding is associated with a greater-than-30% increased risk of cardiovascular events, according to a study published September 26 in Circulation. Researchers performed a cohort study of 601,527 participants taking low-dose aspirin for heart attack and stroke prevention between 2005 and 2009. Participants were older than 40, cancer-free, and had an adherence rate of 80% or greater during the first year of treatment. During a median of 3.0 years of follow-up, 62,690 cardiovascular events were reported. Patients who discontinued aspirin had a higher rate of cardiovascular events than those who continued (multivariable-adjusted hazard ratio, 1.37), corresponding to an additional cardiovascular event observed per year in one of every 74 patients who discontinued aspirin.
Sundström J, Hedberg J, Thuresson M, et al. Low-dose aspirin discontinuation and risk of cardiovascular events: a Swedish nationwide, population-based cohort study. Circulation. 2017;136(13):1183-1192.
FDA Approves 80-mg Ingrezza Capsule for Tardive Dyskinesia
The FDA has approved an 80-mg capsule of Ingrezza (valbenazine) for the treatment of adults with tardive dyskinesia. In clinical studies, Ingrezza 80 mg provided significant, rapid, and meaningful improvement in tardive dyskinesia severity, compared with placebo, at six weeks. Results were seen as early as two weeks, and continued reductions were observed through 48 weeks of treatment. The drug was FDA-approved in April and has been available as 40-mg capsules. Neurocrine Biosciences markets Ingrezza.
FDA Approves Generic Version of Copaxone
The FDA has approved Mylan’s glatiramer acetate injection 40 mg/mL for thrice-weekly injection. The drug is a substitutable generic version of Teva’s Copaxone 40 mg/mL. The agency also approved Mylan’s glatiramer acetate injection 20 mg/mL for once-daily injection, a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both products are indicated for the treatment of patients with relapsing forms of multiple sclerosis. As part of its applications, Mylan submitted side-by-side analyses demonstrating that its glatiramer acetate injections have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart.
FDA Approves Gocovri for Dyskinesia in Parkinson’s Disease
The FDA has approved Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first medicine approved by the FDA for this indication. Gocovri is a high-dose (274 mg) formulation of amantadine (equivalent to 340 mg of amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day. Adamas Pharmaceuticals markets the drug.
FDA Has Approved Lyrica CR for Two Indications
The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. The efficacy and safety of Lyrica CR in postherpetic neuralgia was established in a randomized placebo-controlled clinical trial conducted in 801 patients with postherpetic neuralgia who entered single-blind treatment with Lyrica CR. In the study, 73.6% of patients in the Lyrica CR group achieved at least 50% improvement in pain intensity, compared with 54.6% in the placebo group. The postherpetic neuralgia data also supported the diabetic peripheral neuropathy indication. Pfizer markets Lyrica CR.
—Kimberly Williams
Weight recidivism after bariatric surgery: What constitutes failure?
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
AT OBESITY WEEK 2017
Key clinical point: Many patients regain weight after bariatric surgery, but experts argue over the definition of long-term treatment failure, for which there is no standard.
Major finding: After 5 or more years of follow-up, failure rates range from 25% to 70% depending on definition of unacceptable weight regain.
Data source: A retrospective review.
Disclosures: Dr. Morell and Dr. Martyn reported no financial relationships relevant to this topic.
Up-to-date vaccination status varies by mother’s country of origin
, and, more particularly, on the country of origin of their mother, reported Maureen Leeds and Miriam Halstead Muscoplat of the Minnesota Department of Health, St. Paul.
In a study of 97,885 Minnesota children born during 2011-2012, fewer than half were up to date with their vaccinations by age 18 months and only 70% were up to date by age 36 months.
If children had at least one parent born outside the United States, they were 25% less likely to be up to date with their vaccinations by age 36 months than if both their parents were born in the United States. However, children whose mothers were from Africa (excluding Somalia), the Caribbean, Central and South America, or Mexico were significantly more likely to be up to date at all ages, compared with children whose mothers were born in the United States.
Children whose mothers were born in Asia, Canada, Eastern Europe, Somalia, or Western Europe were significantly less likely to be up to date at all ages than were children whose mothers were born in the United States. At 18 months, fewer than 10% of children whose mothers were born in Somalia were up to date; by 36 months, 44% were.
“Inadequate parental understanding of vaccination and weaker public health education programs in some regions might account for some of these findings, as well as economic and social factors influencing emigration, including fleeing war, religious persecution, or poverty,” Ms. Leeds and Ms. Muscoplat said. “Somali parents in Minnesota have been reported to be more likely than non-Somali parents to have concerns about the safety of measles-mumps-rubella (MMR) vaccine, which has led to a decline in coverage with MMR and possibly other childhood vaccines. From April to August 2017, Minnesota experienced a measles outbreak, ending with 79 confirmed cases, including 65 in children of Somali descent,” they wrote.
“Encouraging medical providers to use interpreters, take time to build trust, and assess vaccination status at every visit might improve vaccination coverage” in immigrant, migrant, and refugee populations, they said.
Read more in Morbidity and Mortality Weekly Report (2017 Oct 27;66[42]:1125-9).
, and, more particularly, on the country of origin of their mother, reported Maureen Leeds and Miriam Halstead Muscoplat of the Minnesota Department of Health, St. Paul.
In a study of 97,885 Minnesota children born during 2011-2012, fewer than half were up to date with their vaccinations by age 18 months and only 70% were up to date by age 36 months.
If children had at least one parent born outside the United States, they were 25% less likely to be up to date with their vaccinations by age 36 months than if both their parents were born in the United States. However, children whose mothers were from Africa (excluding Somalia), the Caribbean, Central and South America, or Mexico were significantly more likely to be up to date at all ages, compared with children whose mothers were born in the United States.
Children whose mothers were born in Asia, Canada, Eastern Europe, Somalia, or Western Europe were significantly less likely to be up to date at all ages than were children whose mothers were born in the United States. At 18 months, fewer than 10% of children whose mothers were born in Somalia were up to date; by 36 months, 44% were.
“Inadequate parental understanding of vaccination and weaker public health education programs in some regions might account for some of these findings, as well as economic and social factors influencing emigration, including fleeing war, religious persecution, or poverty,” Ms. Leeds and Ms. Muscoplat said. “Somali parents in Minnesota have been reported to be more likely than non-Somali parents to have concerns about the safety of measles-mumps-rubella (MMR) vaccine, which has led to a decline in coverage with MMR and possibly other childhood vaccines. From April to August 2017, Minnesota experienced a measles outbreak, ending with 79 confirmed cases, including 65 in children of Somali descent,” they wrote.
“Encouraging medical providers to use interpreters, take time to build trust, and assess vaccination status at every visit might improve vaccination coverage” in immigrant, migrant, and refugee populations, they said.
Read more in Morbidity and Mortality Weekly Report (2017 Oct 27;66[42]:1125-9).
, and, more particularly, on the country of origin of their mother, reported Maureen Leeds and Miriam Halstead Muscoplat of the Minnesota Department of Health, St. Paul.
In a study of 97,885 Minnesota children born during 2011-2012, fewer than half were up to date with their vaccinations by age 18 months and only 70% were up to date by age 36 months.
If children had at least one parent born outside the United States, they were 25% less likely to be up to date with their vaccinations by age 36 months than if both their parents were born in the United States. However, children whose mothers were from Africa (excluding Somalia), the Caribbean, Central and South America, or Mexico were significantly more likely to be up to date at all ages, compared with children whose mothers were born in the United States.
Children whose mothers were born in Asia, Canada, Eastern Europe, Somalia, or Western Europe were significantly less likely to be up to date at all ages than were children whose mothers were born in the United States. At 18 months, fewer than 10% of children whose mothers were born in Somalia were up to date; by 36 months, 44% were.
“Inadequate parental understanding of vaccination and weaker public health education programs in some regions might account for some of these findings, as well as economic and social factors influencing emigration, including fleeing war, religious persecution, or poverty,” Ms. Leeds and Ms. Muscoplat said. “Somali parents in Minnesota have been reported to be more likely than non-Somali parents to have concerns about the safety of measles-mumps-rubella (MMR) vaccine, which has led to a decline in coverage with MMR and possibly other childhood vaccines. From April to August 2017, Minnesota experienced a measles outbreak, ending with 79 confirmed cases, including 65 in children of Somali descent,” they wrote.
“Encouraging medical providers to use interpreters, take time to build trust, and assess vaccination status at every visit might improve vaccination coverage” in immigrant, migrant, and refugee populations, they said.
Read more in Morbidity and Mortality Weekly Report (2017 Oct 27;66[42]:1125-9).
FROM MMWR
Transition to Practice Program Accepting 2018–2019 Applications
Institutions participating in the American College of Surgeons (ACS) Transition to Practice (TTP) Program are now accepting applications for TTP Associates for the 2018−2019 academic year. Interested residents are encouraged to review the program profiles on the ACS website and submit an application to [email protected].
In addition, the TTP Steering Committee is accepting applications from institutions interested in establishing a new TTP Program site. Contact [email protected] for more information on the application process.
The ACS Division of Education launched the TTP Program in 2013 in response to the identified need for autonomous experience for general surgeons leaving residency. The program adds a layer of expertise between residency and independent practice. TTP Associates experience increasing autonomy throughout the year in a broad-based clinical setting, build their competence and confidence in general surgery, develop practice management skills, and gain practical experience for the next phase of their careers. Working closely with experienced surgeons, TTP Associates concentrate on specific areas within general surgery to refine operative skills based on their career goals.
Institutions participating in the American College of Surgeons (ACS) Transition to Practice (TTP) Program are now accepting applications for TTP Associates for the 2018−2019 academic year. Interested residents are encouraged to review the program profiles on the ACS website and submit an application to [email protected].
In addition, the TTP Steering Committee is accepting applications from institutions interested in establishing a new TTP Program site. Contact [email protected] for more information on the application process.
The ACS Division of Education launched the TTP Program in 2013 in response to the identified need for autonomous experience for general surgeons leaving residency. The program adds a layer of expertise between residency and independent practice. TTP Associates experience increasing autonomy throughout the year in a broad-based clinical setting, build their competence and confidence in general surgery, develop practice management skills, and gain practical experience for the next phase of their careers. Working closely with experienced surgeons, TTP Associates concentrate on specific areas within general surgery to refine operative skills based on their career goals.
Institutions participating in the American College of Surgeons (ACS) Transition to Practice (TTP) Program are now accepting applications for TTP Associates for the 2018−2019 academic year. Interested residents are encouraged to review the program profiles on the ACS website and submit an application to [email protected].
In addition, the TTP Steering Committee is accepting applications from institutions interested in establishing a new TTP Program site. Contact [email protected] for more information on the application process.
The ACS Division of Education launched the TTP Program in 2013 in response to the identified need for autonomous experience for general surgeons leaving residency. The program adds a layer of expertise between residency and independent practice. TTP Associates experience increasing autonomy throughout the year in a broad-based clinical setting, build their competence and confidence in general surgery, develop practice management skills, and gain practical experience for the next phase of their careers. Working closely with experienced surgeons, TTP Associates concentrate on specific areas within general surgery to refine operative skills based on their career goals.
Don’t overlook all options for ocular rosacea
Managing ocular rosacea often includes a combination of oral and topical treatments, and some patients find relief with natural strategies such as warm compresses and eyelid massage, Julie C. Harper, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Ocular rosacea can present in several forms, including sties on the eyelids, blepharitis with chalazia and telangiectasia, and “meibomian inspissation visible as pale streaks perpendicular to the lid margin,” according to a 2016 review article she cited (Clin Dermatol. 2016 Mar-Apr;34[2]:146-50).
The most common symptoms at baseline were burning, stinging, and light sensitivity. At baseline, all the cyclosporine-treated patients had burning, stinging, and light sensitivity, which dropped to 21%, 47%, and 10.5% of the patients, respectively, after 3 months of twice-daily topical treatment. In the study, all patients also were administering artificial eye drops daily.
The patients treated with doxycycline also showed improvement in these three symptoms after 3 months of treatment, but not to the same degree: At 3 months, 74% still had burning and stinging, from 100% at baseline. Almost 95% had light sensitivity at baseline, dropping to 21% after 3 months of treatment.
When treating patients with ocular rosacea, “the greatest challenge is that we don’t have any medications that are Food and Drug Administration–approved for this indication,” Dr. Harper said in an interview.
In the interview, she provided the following pearl: “Always ask about eye involvement in rosacea patients; they won’t volunteer information because they think it is unrelated. Teach patients about lid care (lid massage and artificial tears). This is analogous to good skin care in cutaneous rosacea.”
Dr. Harper disclosed serving as a speaker/adviser for Allergan, Bayer, and Galderma, and receiving research support from Bayer. SDEF and this news organization are owned by the same parent company.
Managing ocular rosacea often includes a combination of oral and topical treatments, and some patients find relief with natural strategies such as warm compresses and eyelid massage, Julie C. Harper, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Ocular rosacea can present in several forms, including sties on the eyelids, blepharitis with chalazia and telangiectasia, and “meibomian inspissation visible as pale streaks perpendicular to the lid margin,” according to a 2016 review article she cited (Clin Dermatol. 2016 Mar-Apr;34[2]:146-50).
The most common symptoms at baseline were burning, stinging, and light sensitivity. At baseline, all the cyclosporine-treated patients had burning, stinging, and light sensitivity, which dropped to 21%, 47%, and 10.5% of the patients, respectively, after 3 months of twice-daily topical treatment. In the study, all patients also were administering artificial eye drops daily.
The patients treated with doxycycline also showed improvement in these three symptoms after 3 months of treatment, but not to the same degree: At 3 months, 74% still had burning and stinging, from 100% at baseline. Almost 95% had light sensitivity at baseline, dropping to 21% after 3 months of treatment.
When treating patients with ocular rosacea, “the greatest challenge is that we don’t have any medications that are Food and Drug Administration–approved for this indication,” Dr. Harper said in an interview.
In the interview, she provided the following pearl: “Always ask about eye involvement in rosacea patients; they won’t volunteer information because they think it is unrelated. Teach patients about lid care (lid massage and artificial tears). This is analogous to good skin care in cutaneous rosacea.”
Dr. Harper disclosed serving as a speaker/adviser for Allergan, Bayer, and Galderma, and receiving research support from Bayer. SDEF and this news organization are owned by the same parent company.
Managing ocular rosacea often includes a combination of oral and topical treatments, and some patients find relief with natural strategies such as warm compresses and eyelid massage, Julie C. Harper, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Ocular rosacea can present in several forms, including sties on the eyelids, blepharitis with chalazia and telangiectasia, and “meibomian inspissation visible as pale streaks perpendicular to the lid margin,” according to a 2016 review article she cited (Clin Dermatol. 2016 Mar-Apr;34[2]:146-50).
The most common symptoms at baseline were burning, stinging, and light sensitivity. At baseline, all the cyclosporine-treated patients had burning, stinging, and light sensitivity, which dropped to 21%, 47%, and 10.5% of the patients, respectively, after 3 months of twice-daily topical treatment. In the study, all patients also were administering artificial eye drops daily.
The patients treated with doxycycline also showed improvement in these three symptoms after 3 months of treatment, but not to the same degree: At 3 months, 74% still had burning and stinging, from 100% at baseline. Almost 95% had light sensitivity at baseline, dropping to 21% after 3 months of treatment.
When treating patients with ocular rosacea, “the greatest challenge is that we don’t have any medications that are Food and Drug Administration–approved for this indication,” Dr. Harper said in an interview.
In the interview, she provided the following pearl: “Always ask about eye involvement in rosacea patients; they won’t volunteer information because they think it is unrelated. Teach patients about lid care (lid massage and artificial tears). This is analogous to good skin care in cutaneous rosacea.”
Dr. Harper disclosed serving as a speaker/adviser for Allergan, Bayer, and Galderma, and receiving research support from Bayer. SDEF and this news organization are owned by the same parent company.
AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Taking urine samples from infants
Urinary tract infection (UTI) is one of the most common bacterial infections in young febrile infants, but doctors know that collecting a urine sample to diagnose or exclude UTI can be very challenging in practice.
Recently, researchers in Australia conducted a randomized controlled trial in a pediatric hospital emergency department to test a method that could stimulate voiding within 5 minutes. It’s called the Quick-Wee method, and the technique involves the clinician rubbing the suprapubic area of the child in a circular pattern with gauze soaked in cold saline held with disposable plastic forceps. In the trial, this was done until the sample was obtained or until 5 minutes passed.
For some young children, when a urine sample is required, a catheter or suprapubic needle aspirate sample will be indicated, he added. “But for many others, the Quick-Wee method may allow clinicians to collect a clean catch sample, and spare the need for painful and invasive procedures in some circumstances.”
Reference
Kaufman J, Fitzpatrick P, Tosif S, et al. Faster clean catch urine collection (Quick-Wee method) from infants: randomised controlled trial. BMJ 2017;357:j1341. doi: 10.1136/bmj.j1341. Accessed June 12, 2017.
Urinary tract infection (UTI) is one of the most common bacterial infections in young febrile infants, but doctors know that collecting a urine sample to diagnose or exclude UTI can be very challenging in practice.
Recently, researchers in Australia conducted a randomized controlled trial in a pediatric hospital emergency department to test a method that could stimulate voiding within 5 minutes. It’s called the Quick-Wee method, and the technique involves the clinician rubbing the suprapubic area of the child in a circular pattern with gauze soaked in cold saline held with disposable plastic forceps. In the trial, this was done until the sample was obtained or until 5 minutes passed.
For some young children, when a urine sample is required, a catheter or suprapubic needle aspirate sample will be indicated, he added. “But for many others, the Quick-Wee method may allow clinicians to collect a clean catch sample, and spare the need for painful and invasive procedures in some circumstances.”
Reference
Kaufman J, Fitzpatrick P, Tosif S, et al. Faster clean catch urine collection (Quick-Wee method) from infants: randomised controlled trial. BMJ 2017;357:j1341. doi: 10.1136/bmj.j1341. Accessed June 12, 2017.
Urinary tract infection (UTI) is one of the most common bacterial infections in young febrile infants, but doctors know that collecting a urine sample to diagnose or exclude UTI can be very challenging in practice.
Recently, researchers in Australia conducted a randomized controlled trial in a pediatric hospital emergency department to test a method that could stimulate voiding within 5 minutes. It’s called the Quick-Wee method, and the technique involves the clinician rubbing the suprapubic area of the child in a circular pattern with gauze soaked in cold saline held with disposable plastic forceps. In the trial, this was done until the sample was obtained or until 5 minutes passed.
For some young children, when a urine sample is required, a catheter or suprapubic needle aspirate sample will be indicated, he added. “But for many others, the Quick-Wee method may allow clinicians to collect a clean catch sample, and spare the need for painful and invasive procedures in some circumstances.”
Reference
Kaufman J, Fitzpatrick P, Tosif S, et al. Faster clean catch urine collection (Quick-Wee method) from infants: randomised controlled trial. BMJ 2017;357:j1341. doi: 10.1136/bmj.j1341. Accessed June 12, 2017.
Analysis indicates coprescribing of tetracyclines, isotretinoin is low
LAS VEGAS – Coprescribing isotretinoin and tetracycline antibiotics among dermatologists and nondermatologists was low, according to a study that analyzed 11 years of ambulatory medical data.
The findings were presented in a poster at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with an inadequate response to tetracyclines or severe cases of acne may require isotretinoin,” wrote Brooke Vasicek, MD, of Loyola University Chicago in Maywood, Ill., and colleagues. However, since the combined use of tetracyclines and isotretinoin puts patients at risk of pseudotumor cerebri, which may lead to blindness, “concurrent use of these medications must be avoided,” they explained.
To assess the frequency of isotretinoin/tetracycline coprescribing, they reviewed data from the National Ambulatory Medical Care Survey collected during 2003-2013 and estimated the number of prescriptions for isotretinoin and/or tetracycline. The dataset included 51,980,042 visits to dermatologists for acne and 29,063,717 visits to nondermatologists.
Of the dermatologists in the survey data, 13.6% reported prescribing isotretinoin (compared with 1.6% of nondermatologists), 29.2% reported prescribing tetracycline (compared with 22.9% of nondermatologists), and 0.40% reported concurrently prescribing both medications (compared with .025% of nondermatologists).
Dermatologists were significantly more likely to mention isotretinoin than nondermatologists, but mention of tetracycline was not significantly different among specialties. “Acne severity and level of comfort because of specialty-based training may be at play in the isotretinoin prescribing pattern differences between dermatologists and nondermatologists,” the researchers noted. The increased pseudotumor cerebri risk associated with combining the medications “is well known among dermatologists, hence, patient exposure is likely very uncommon,” they added.
The results were limited by the cross-sectional nature of the study and possible sampling bias associated with the data collection source, they said.
The researchers had no financial conflicts to disclose.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Coprescribing isotretinoin and tetracycline antibiotics among dermatologists and nondermatologists was low, according to a study that analyzed 11 years of ambulatory medical data.
The findings were presented in a poster at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with an inadequate response to tetracyclines or severe cases of acne may require isotretinoin,” wrote Brooke Vasicek, MD, of Loyola University Chicago in Maywood, Ill., and colleagues. However, since the combined use of tetracyclines and isotretinoin puts patients at risk of pseudotumor cerebri, which may lead to blindness, “concurrent use of these medications must be avoided,” they explained.
To assess the frequency of isotretinoin/tetracycline coprescribing, they reviewed data from the National Ambulatory Medical Care Survey collected during 2003-2013 and estimated the number of prescriptions for isotretinoin and/or tetracycline. The dataset included 51,980,042 visits to dermatologists for acne and 29,063,717 visits to nondermatologists.
Of the dermatologists in the survey data, 13.6% reported prescribing isotretinoin (compared with 1.6% of nondermatologists), 29.2% reported prescribing tetracycline (compared with 22.9% of nondermatologists), and 0.40% reported concurrently prescribing both medications (compared with .025% of nondermatologists).
Dermatologists were significantly more likely to mention isotretinoin than nondermatologists, but mention of tetracycline was not significantly different among specialties. “Acne severity and level of comfort because of specialty-based training may be at play in the isotretinoin prescribing pattern differences between dermatologists and nondermatologists,” the researchers noted. The increased pseudotumor cerebri risk associated with combining the medications “is well known among dermatologists, hence, patient exposure is likely very uncommon,” they added.
The results were limited by the cross-sectional nature of the study and possible sampling bias associated with the data collection source, they said.
The researchers had no financial conflicts to disclose.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Coprescribing isotretinoin and tetracycline antibiotics among dermatologists and nondermatologists was low, according to a study that analyzed 11 years of ambulatory medical data.
The findings were presented in a poster at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with an inadequate response to tetracyclines or severe cases of acne may require isotretinoin,” wrote Brooke Vasicek, MD, of Loyola University Chicago in Maywood, Ill., and colleagues. However, since the combined use of tetracyclines and isotretinoin puts patients at risk of pseudotumor cerebri, which may lead to blindness, “concurrent use of these medications must be avoided,” they explained.
To assess the frequency of isotretinoin/tetracycline coprescribing, they reviewed data from the National Ambulatory Medical Care Survey collected during 2003-2013 and estimated the number of prescriptions for isotretinoin and/or tetracycline. The dataset included 51,980,042 visits to dermatologists for acne and 29,063,717 visits to nondermatologists.
Of the dermatologists in the survey data, 13.6% reported prescribing isotretinoin (compared with 1.6% of nondermatologists), 29.2% reported prescribing tetracycline (compared with 22.9% of nondermatologists), and 0.40% reported concurrently prescribing both medications (compared with .025% of nondermatologists).
Dermatologists were significantly more likely to mention isotretinoin than nondermatologists, but mention of tetracycline was not significantly different among specialties. “Acne severity and level of comfort because of specialty-based training may be at play in the isotretinoin prescribing pattern differences between dermatologists and nondermatologists,” the researchers noted. The increased pseudotumor cerebri risk associated with combining the medications “is well known among dermatologists, hence, patient exposure is likely very uncommon,” they added.
The results were limited by the cross-sectional nature of the study and possible sampling bias associated with the data collection source, they said.
The researchers had no financial conflicts to disclose.
SDEF and this news organization are owned by the same parent company.
AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Key clinical point: Most clinicians understand the risk of pseudotumor cerebri associated with concurrent use of tetracyclines and isotretinoin.
Major finding: Very few dermatologists (0.40%) and nondermatologists (0.025%) mentioned both tetracycline and isotretinoin at a clinical visit for acne.
Data source: The data for this cross-sectional study came from the National Ambulatory Medical Care Survey from 2003 to 2013 and included 51,980,042 acne visits to dermatologists and 29,063,717 acne visits to nondermatologists.
Disclosures: The researchers had no financial conflicts to disclose.
Nondermatologists more likely to prescribe nystatin for dermatophyte infections, survey finds
LAS VEGAS – Nondermatologists were 11 times more likely than dermatologists to prescribe nystatin for dermatophyte infections, according to a study that analyzed 12 years of ambulatory-care data in the United States.
The findings were presented in a poster at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Although it is effective for the treatment of cutaneous or mucocutaneous candidiasis, the topical polyene nystatin, however, is clinically ineffective in the treatment of dermatophyte infection,” wrote Jeave Reserva, MD, of the division of dermatology at Loyola University Health System in Illinois, and colleagues.
In their analysis, the researchers used 12 years of data from two separate surveys – the National Ambulatory Medical Care Surveys and the National Hospital Ambulatory Medical Care Survey–Emergency Department – collected between 2003 and 2014, as well as 9 years of data from the National Hospital Ambulatory Medical Care Survey–Outpatient Department collected between 2003 and 2011. They reviewed data from 48.4 million ambulatory-care visits for dermatophyte infections, including 1,459,184 visits in which nystatin was prescribed. Overall, nondermatologists were significantly more likely than dermatologists to prescribe nystatin. The researchers also found that, after controlling for race, gender, and insurance status, male or black patients were significantly more likely to have positive tinea infections.
Nondermatologists were 11.08 times more likely to prescribe nystatin for dermatophytosis, compared with dermatologists (P = .02), the researchers found.
Although the number of visits does not reflect disease prevalence, the results suggest that health care disparities affect patients presenting with dermatophytosis, the researchers said. “Nondermatologists may benefit from additional provider education on the diagnosis and appropriate treatment of dermatophyte infections,” they concluded.
The researchers had no financial conflicts to disclose; no funding source was listed.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Nondermatologists were 11 times more likely than dermatologists to prescribe nystatin for dermatophyte infections, according to a study that analyzed 12 years of ambulatory-care data in the United States.
The findings were presented in a poster at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Although it is effective for the treatment of cutaneous or mucocutaneous candidiasis, the topical polyene nystatin, however, is clinically ineffective in the treatment of dermatophyte infection,” wrote Jeave Reserva, MD, of the division of dermatology at Loyola University Health System in Illinois, and colleagues.
In their analysis, the researchers used 12 years of data from two separate surveys – the National Ambulatory Medical Care Surveys and the National Hospital Ambulatory Medical Care Survey–Emergency Department – collected between 2003 and 2014, as well as 9 years of data from the National Hospital Ambulatory Medical Care Survey–Outpatient Department collected between 2003 and 2011. They reviewed data from 48.4 million ambulatory-care visits for dermatophyte infections, including 1,459,184 visits in which nystatin was prescribed. Overall, nondermatologists were significantly more likely than dermatologists to prescribe nystatin. The researchers also found that, after controlling for race, gender, and insurance status, male or black patients were significantly more likely to have positive tinea infections.
Nondermatologists were 11.08 times more likely to prescribe nystatin for dermatophytosis, compared with dermatologists (P = .02), the researchers found.
Although the number of visits does not reflect disease prevalence, the results suggest that health care disparities affect patients presenting with dermatophytosis, the researchers said. “Nondermatologists may benefit from additional provider education on the diagnosis and appropriate treatment of dermatophyte infections,” they concluded.
The researchers had no financial conflicts to disclose; no funding source was listed.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Nondermatologists were 11 times more likely than dermatologists to prescribe nystatin for dermatophyte infections, according to a study that analyzed 12 years of ambulatory-care data in the United States.
The findings were presented in a poster at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Although it is effective for the treatment of cutaneous or mucocutaneous candidiasis, the topical polyene nystatin, however, is clinically ineffective in the treatment of dermatophyte infection,” wrote Jeave Reserva, MD, of the division of dermatology at Loyola University Health System in Illinois, and colleagues.
In their analysis, the researchers used 12 years of data from two separate surveys – the National Ambulatory Medical Care Surveys and the National Hospital Ambulatory Medical Care Survey–Emergency Department – collected between 2003 and 2014, as well as 9 years of data from the National Hospital Ambulatory Medical Care Survey–Outpatient Department collected between 2003 and 2011. They reviewed data from 48.4 million ambulatory-care visits for dermatophyte infections, including 1,459,184 visits in which nystatin was prescribed. Overall, nondermatologists were significantly more likely than dermatologists to prescribe nystatin. The researchers also found that, after controlling for race, gender, and insurance status, male or black patients were significantly more likely to have positive tinea infections.
Nondermatologists were 11.08 times more likely to prescribe nystatin for dermatophytosis, compared with dermatologists (P = .02), the researchers found.
Although the number of visits does not reflect disease prevalence, the results suggest that health care disparities affect patients presenting with dermatophytosis, the researchers said. “Nondermatologists may benefit from additional provider education on the diagnosis and appropriate treatment of dermatophyte infections,” they concluded.
The researchers had no financial conflicts to disclose; no funding source was listed.
SDEF and this news organization are owned by the same parent company.
AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Key clinical point: Nondermatologists may not be aware that nystatin is not effective for treating dermatophyte infections.
Major finding: Nondermatologists were 11.08 times more likely than dermatologists to prescribe nystatin for dermatophyte infections.
Data source: The data came from the National Ambulatory Medical Care Survey, National Hospital Ambulatory Medical Care Survey–Emergency Department, and National Hospital Ambulatory Medical Care Survey–Outpatient Department and included 1,459,184 visits between 2003 and 2014 in which nystatin was prescribed.
Disclosures: The researchers had no financial conflicts to disclose.