Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).

Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.

Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.

How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.

For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.

You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.

How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).

Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.

Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.

How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.

For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.

You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.

How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).

Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.

Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.

How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.

For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.

You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.

How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The novel glucagonlike peptide 1 (GLP-1) receptor agonist semaglutide may reduce the risk of cardiovascular events in patients with type 2 diabetes who are at elevated cardiovascular risk, according to data presented Sept. 16 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published online in the New England Journal of Medicine.

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Steven P. Marso, MD, and his coinvestigators.

SUSTAIN-6 was a randomized, placebo-controlled, noninferiority trial in which 3,297 patients with type 2 diabetes, 85% of whom had established cardiovascular disease, were assigned to take either once-weekly semaglutide (0.5 mg or 1 mg) or placebo.

At the end of the 2-year study period, patients on semaglutide had a statistically significant, 26% lower risk of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, the study’s primary composite outcome, compared with those on placebo (P less than .001), Dr. Marso and his associates wrote. This outcome occurred in 108 of 1,648 patients (6.6%) in the semaglutide group and in 146 of 1,649 patients (8.9%) in the placebo group.

Specifically, the study showed a 26% reduction in the risk of nonfatal MI (P = .12) and 39% reduction in nonfatal stroke (P = .04) with semaglutide, while the rates of cardiovascular death and heart failure hospitalizations were similar between the two arms of the study.

Overall, 60.5% of the patients in the study had a history of cardiovascular disease, and nearly one-third had a history of MI (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMoa1607141).

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Dr. Marso of the Research Medical Center in Kansas City, Mo., and coauthors. “The beneficial effect of semaglutide on cardiovascular outcomes may relate to modification of the progression of atherosclerosis.”

Semaglutide has a longer duration of action than the approved GLP-1 receptor agonists – liraglutide, exenatide, albiglutide, dulaglutide, and lixisenatide – allowing for once-weekly subcutaneous injection.

Patients enrolled in the study were all on a standard care regimen, but those taking semaglutide showed significant and sustained reductions in hemoglobin A_1c levels, compared with placebo, as well as a higher incidence of clinically meaningful and sustained weight loss, and reductions in systolic blood pressure.

The reductions in HbA_1c, body weight, and systolic blood pressure may all have contributed to the observed reduction in cardiovascular risk with semaglutide,” the authors noted.

The study did observe significantly higher rates of diabetic retinopathy complications in patients taking semaglutide. The overall incidence of these complications occurred in 50 patients (3.0%) in the semaglutide group and 29 (1.8%) of the placebo patients, yielding a hazard ratio of 1.76 (P = .02). More patients in the semaglutide group required retinal photocoagulation or the use of an intravitreal agent, had a vitreous hemorrhage, or had developed diabetes-related blindness.

However, patients taking semaglutide also had a 36% lower incidence of new or worsening nephropathy (P = .005), and the frequency of serious adverse events was also lower in the semaglutide group than in the placebo patients.

“With the exception of complications of retinopathy, semaglutide had a safety profile similar to that of other GLP-1 receptor agonists,” the authors reported. The rates of malignant neoplasms were similar in both arms of the study, and the rate of pancreatic cancer, which is known to be an event of interest for this class of drugs, was lower in the semaglutide arm, compared with placebo.

Semaglutide is in development and not yet approved for the treatment of type 2 diabetes.

Starting in 2008, all new drug applications to the Food and Drug Administration for antihyperglycemic agents must include evidence that therapy will not increase the risk of cardiovascular events; SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-Term Outcomes With Semaglutide in Subjects with Type 2 Diabetes) was designed to fill that need for semaglutide, and is being developed by Novo Nordisk.

The study was supported by Novo Nordisk. Thirteen authors declared consultancies, grants, fees, and other support from pharmaceutical companies, including Novo Nordisk, and three authors were employees of Novo Nordisk.

The novel glucagonlike peptide 1 (GLP-1) receptor agonist semaglutide may reduce the risk of cardiovascular events in patients with type 2 diabetes who are at elevated cardiovascular risk, according to data presented Sept. 16 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published online in the New England Journal of Medicine.

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Steven P. Marso, MD, and his coinvestigators.

SUSTAIN-6 was a randomized, placebo-controlled, noninferiority trial in which 3,297 patients with type 2 diabetes, 85% of whom had established cardiovascular disease, were assigned to take either once-weekly semaglutide (0.5 mg or 1 mg) or placebo.

At the end of the 2-year study period, patients on semaglutide had a statistically significant, 26% lower risk of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, the study’s primary composite outcome, compared with those on placebo (P less than .001), Dr. Marso and his associates wrote. This outcome occurred in 108 of 1,648 patients (6.6%) in the semaglutide group and in 146 of 1,649 patients (8.9%) in the placebo group.

Specifically, the study showed a 26% reduction in the risk of nonfatal MI (P = .12) and 39% reduction in nonfatal stroke (P = .04) with semaglutide, while the rates of cardiovascular death and heart failure hospitalizations were similar between the two arms of the study.

Overall, 60.5% of the patients in the study had a history of cardiovascular disease, and nearly one-third had a history of MI (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMoa1607141).

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Dr. Marso of the Research Medical Center in Kansas City, Mo., and coauthors. “The beneficial effect of semaglutide on cardiovascular outcomes may relate to modification of the progression of atherosclerosis.”

Semaglutide has a longer duration of action than the approved GLP-1 receptor agonists – liraglutide, exenatide, albiglutide, dulaglutide, and lixisenatide – allowing for once-weekly subcutaneous injection.

Patients enrolled in the study were all on a standard care regimen, but those taking semaglutide showed significant and sustained reductions in hemoglobin A_1c levels, compared with placebo, as well as a higher incidence of clinically meaningful and sustained weight loss, and reductions in systolic blood pressure.

The reductions in HbA_1c, body weight, and systolic blood pressure may all have contributed to the observed reduction in cardiovascular risk with semaglutide,” the authors noted.

The study did observe significantly higher rates of diabetic retinopathy complications in patients taking semaglutide. The overall incidence of these complications occurred in 50 patients (3.0%) in the semaglutide group and 29 (1.8%) of the placebo patients, yielding a hazard ratio of 1.76 (P = .02). More patients in the semaglutide group required retinal photocoagulation or the use of an intravitreal agent, had a vitreous hemorrhage, or had developed diabetes-related blindness.

However, patients taking semaglutide also had a 36% lower incidence of new or worsening nephropathy (P = .005), and the frequency of serious adverse events was also lower in the semaglutide group than in the placebo patients.

“With the exception of complications of retinopathy, semaglutide had a safety profile similar to that of other GLP-1 receptor agonists,” the authors reported. The rates of malignant neoplasms were similar in both arms of the study, and the rate of pancreatic cancer, which is known to be an event of interest for this class of drugs, was lower in the semaglutide arm, compared with placebo.

Semaglutide is in development and not yet approved for the treatment of type 2 diabetes.

Starting in 2008, all new drug applications to the Food and Drug Administration for antihyperglycemic agents must include evidence that therapy will not increase the risk of cardiovascular events; SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-Term Outcomes With Semaglutide in Subjects with Type 2 Diabetes) was designed to fill that need for semaglutide, and is being developed by Novo Nordisk.

The study was supported by Novo Nordisk. Thirteen authors declared consultancies, grants, fees, and other support from pharmaceutical companies, including Novo Nordisk, and three authors were employees of Novo Nordisk.

The novel glucagonlike peptide 1 (GLP-1) receptor agonist semaglutide may reduce the risk of cardiovascular events in patients with type 2 diabetes who are at elevated cardiovascular risk, according to data presented Sept. 16 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published online in the New England Journal of Medicine.

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Steven P. Marso, MD, and his coinvestigators.

SUSTAIN-6 was a randomized, placebo-controlled, noninferiority trial in which 3,297 patients with type 2 diabetes, 85% of whom had established cardiovascular disease, were assigned to take either once-weekly semaglutide (0.5 mg or 1 mg) or placebo.

At the end of the 2-year study period, patients on semaglutide had a statistically significant, 26% lower risk of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, the study’s primary composite outcome, compared with those on placebo (P less than .001), Dr. Marso and his associates wrote. This outcome occurred in 108 of 1,648 patients (6.6%) in the semaglutide group and in 146 of 1,649 patients (8.9%) in the placebo group.

Specifically, the study showed a 26% reduction in the risk of nonfatal MI (P = .12) and 39% reduction in nonfatal stroke (P = .04) with semaglutide, while the rates of cardiovascular death and heart failure hospitalizations were similar between the two arms of the study.

Overall, 60.5% of the patients in the study had a history of cardiovascular disease, and nearly one-third had a history of MI (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMoa1607141).

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Dr. Marso of the Research Medical Center in Kansas City, Mo., and coauthors. “The beneficial effect of semaglutide on cardiovascular outcomes may relate to modification of the progression of atherosclerosis.”

Semaglutide has a longer duration of action than the approved GLP-1 receptor agonists – liraglutide, exenatide, albiglutide, dulaglutide, and lixisenatide – allowing for once-weekly subcutaneous injection.

Patients enrolled in the study were all on a standard care regimen, but those taking semaglutide showed significant and sustained reductions in hemoglobin A_1c levels, compared with placebo, as well as a higher incidence of clinically meaningful and sustained weight loss, and reductions in systolic blood pressure.

The reductions in HbA_1c, body weight, and systolic blood pressure may all have contributed to the observed reduction in cardiovascular risk with semaglutide,” the authors noted.

The study did observe significantly higher rates of diabetic retinopathy complications in patients taking semaglutide. The overall incidence of these complications occurred in 50 patients (3.0%) in the semaglutide group and 29 (1.8%) of the placebo patients, yielding a hazard ratio of 1.76 (P = .02). More patients in the semaglutide group required retinal photocoagulation or the use of an intravitreal agent, had a vitreous hemorrhage, or had developed diabetes-related blindness.

However, patients taking semaglutide also had a 36% lower incidence of new or worsening nephropathy (P = .005), and the frequency of serious adverse events was also lower in the semaglutide group than in the placebo patients.

“With the exception of complications of retinopathy, semaglutide had a safety profile similar to that of other GLP-1 receptor agonists,” the authors reported. The rates of malignant neoplasms were similar in both arms of the study, and the rate of pancreatic cancer, which is known to be an event of interest for this class of drugs, was lower in the semaglutide arm, compared with placebo.

Semaglutide is in development and not yet approved for the treatment of type 2 diabetes.

Starting in 2008, all new drug applications to the Food and Drug Administration for antihyperglycemic agents must include evidence that therapy will not increase the risk of cardiovascular events; SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-Term Outcomes With Semaglutide in Subjects with Type 2 Diabetes) was designed to fill that need for semaglutide, and is being developed by Novo Nordisk.

The study was supported by Novo Nordisk. Thirteen authors declared consultancies, grants, fees, and other support from pharmaceutical companies, including Novo Nordisk, and three authors were employees of Novo Nordisk.

An analysis of 27 studies involving over 3000 patients with drug resistant temporal lobe epilepsy has shed light on the value of various type of neuroimaging. Seven studies suggest that clinical outcomes are more favorable when patients have MRI-identified hippocampal atrophy and mesial temporal sclerosis. On the other hand, 5 studies concluded that outcomes were less favorable when patients had unremarkable MIR findings. The value of PET imaging seems less clear. Study findings were inconsistent on the prognostic value of PET-identified focal hypometabolism, for instance.    

Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016;73(4):464-470.

An analysis of 27 studies involving over 3000 patients with drug resistant temporal lobe epilepsy has shed light on the value of various type of neuroimaging. Seven studies suggest that clinical outcomes are more favorable when patients have MRI-identified hippocampal atrophy and mesial temporal sclerosis. On the other hand, 5 studies concluded that outcomes were less favorable when patients had unremarkable MIR findings. The value of PET imaging seems less clear. Study findings were inconsistent on the prognostic value of PET-identified focal hypometabolism, for instance.    

Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016;73(4):464-470.

An analysis of 27 studies involving over 3000 patients with drug resistant temporal lobe epilepsy has shed light on the value of various type of neuroimaging. Seven studies suggest that clinical outcomes are more favorable when patients have MRI-identified hippocampal atrophy and mesial temporal sclerosis. On the other hand, 5 studies concluded that outcomes were less favorable when patients had unremarkable MIR findings. The value of PET imaging seems less clear. Study findings were inconsistent on the prognostic value of PET-identified focal hypometabolism, for instance.    

Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016;73(4):464-470.

In an effort to detect links between seizure clusters and as yet unknown clinical factors among patients with drug-resistant focal epilepsy, researchers performed a retrospective analysis of 764 patients. They found clustering in 23.6% of patients with temporal lobe epilepsy (TLE) and 16.9% of patients with extratemporal seizures. Unfortunately, they failed to detect any clinical factors associated with the clustering. However, they did notice that TLE patients fared better after surgery if they had a history of seizure clusters.

Asadi-Pooya AA, Nei M, Sharan A, Sperling MR. Seizure clusters in drug-resistant focal epilepsy. Epilepsia. 2016;57(9):e187-e190.

In an effort to detect links between seizure clusters and as yet unknown clinical factors among patients with drug-resistant focal epilepsy, researchers performed a retrospective analysis of 764 patients. They found clustering in 23.6% of patients with temporal lobe epilepsy (TLE) and 16.9% of patients with extratemporal seizures. Unfortunately, they failed to detect any clinical factors associated with the clustering. However, they did notice that TLE patients fared better after surgery if they had a history of seizure clusters.

Asadi-Pooya AA, Nei M, Sharan A, Sperling MR. Seizure clusters in drug-resistant focal epilepsy. Epilepsia. 2016;57(9):e187-e190.

In an effort to detect links between seizure clusters and as yet unknown clinical factors among patients with drug-resistant focal epilepsy, researchers performed a retrospective analysis of 764 patients. They found clustering in 23.6% of patients with temporal lobe epilepsy (TLE) and 16.9% of patients with extratemporal seizures. Unfortunately, they failed to detect any clinical factors associated with the clustering. However, they did notice that TLE patients fared better after surgery if they had a history of seizure clusters.

Asadi-Pooya AA, Nei M, Sharan A, Sperling MR. Seizure clusters in drug-resistant focal epilepsy. Epilepsia. 2016;57(9):e187-e190.

Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.

Balter S, Lin G, Leyden KM, Paul BM, McDonald CR. Neuroimaging correlates of language network impairment and reorganization in temporal lobe epilepsy. Brain Lang. 2016:pii S0093-934X(15)30127-9.

Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.

Balter S, Lin G, Leyden KM, Paul BM, McDonald CR. Neuroimaging correlates of language network impairment and reorganization in temporal lobe epilepsy. Brain Lang. 2016:pii S0093-934X(15)30127-9.

Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.

Balter S, Lin G, Leyden KM, Paul BM, McDonald CR. Neuroimaging correlates of language network impairment and reorganization in temporal lobe epilepsy. Brain Lang. 2016:pii S0093-934X(15)30127-9.

The Food and Drug Administration has approved the aspirin/omeprazole combination drug Yosprala for patients who seek to prevent secondary cardiovascular events but who avoid aspirin because of their risk for gastric ulcers. The approval was announced in a press release Sept. 15 from Aralez Pharmaceuticals.

The medication contains 40 mg of immediate-release omeprazole and either 81 mg or 325 mg of aspirin in an enteric-coated core for delayed release. The immediate-release omeprazole “is designed to elevate the gastric pH into a gastroprotective zone,” according to the company. “The enteric-coated aspirin dissolves after the pH has been elevated to at least 5.5 within the gastroprotective zone, thereby reducing stomach ulcer risk.”

The approval is based on data from a pair of randomized, double-blind, controlled trials. In these studies, patients at risk for gastric ulcers were significantly less likely to report ulcers and significantly less likely to discontinue the medication than were controls who received aspirin alone. Side effects were not significantly different between the groups; the most common side effects were indigestion, stomach pain, nausea, diarrhea, gastric polyps, and chest pain.

The studies did not examine whether the medication had an impact on the risk of GI bleeding. The drug is not approved for use in children.

The Food and Drug Administration has approved the aspirin/omeprazole combination drug Yosprala for patients who seek to prevent secondary cardiovascular events but who avoid aspirin because of their risk for gastric ulcers. The approval was announced in a press release Sept. 15 from Aralez Pharmaceuticals.

The medication contains 40 mg of immediate-release omeprazole and either 81 mg or 325 mg of aspirin in an enteric-coated core for delayed release. The immediate-release omeprazole “is designed to elevate the gastric pH into a gastroprotective zone,” according to the company. “The enteric-coated aspirin dissolves after the pH has been elevated to at least 5.5 within the gastroprotective zone, thereby reducing stomach ulcer risk.”

The approval is based on data from a pair of randomized, double-blind, controlled trials. In these studies, patients at risk for gastric ulcers were significantly less likely to report ulcers and significantly less likely to discontinue the medication than were controls who received aspirin alone. Side effects were not significantly different between the groups; the most common side effects were indigestion, stomach pain, nausea, diarrhea, gastric polyps, and chest pain.

The studies did not examine whether the medication had an impact on the risk of GI bleeding. The drug is not approved for use in children.

The Food and Drug Administration has approved the aspirin/omeprazole combination drug Yosprala for patients who seek to prevent secondary cardiovascular events but who avoid aspirin because of their risk for gastric ulcers. The approval was announced in a press release Sept. 15 from Aralez Pharmaceuticals.

The medication contains 40 mg of immediate-release omeprazole and either 81 mg or 325 mg of aspirin in an enteric-coated core for delayed release. The immediate-release omeprazole “is designed to elevate the gastric pH into a gastroprotective zone,” according to the company. “The enteric-coated aspirin dissolves after the pH has been elevated to at least 5.5 within the gastroprotective zone, thereby reducing stomach ulcer risk.”

The approval is based on data from a pair of randomized, double-blind, controlled trials. In these studies, patients at risk for gastric ulcers were significantly less likely to report ulcers and significantly less likely to discontinue the medication than were controls who received aspirin alone. Side effects were not significantly different between the groups; the most common side effects were indigestion, stomach pain, nausea, diarrhea, gastric polyps, and chest pain.

The studies did not examine whether the medication had an impact on the risk of GI bleeding. The drug is not approved for use in children.

MUNICH – Enough studies exist now to support the notion of dual therapy in type 2 diabetes. But, with 13 classes of antihyperglycemic drugs approved in the United States – 7 of which are considered major – how does anyone make sense of the myriad of possible combinations?

It’s not a bad problem to have, Ele Ferrannini, MD, said shortly before the DURATION-8 data were presented at the annual meeting of the European Association for the Study of Diabetes.

“We have seen an explosion of pharmacological treatment options for type 2 diabetes in the last 20 years, which is really unprecedented, especially if we compare that to what has happened in hypertension or cardiology,” said Dr. Ferrannini of the University of Pisa (Italy). “This has given us the blessing of multiple options for treatment. But we are also now at a slight disadvantage. We all agree that we should advocate for combination treatment as early and aggressively as possible for our type 2 diabetes patients, but the question is, What combination?”

The question cannot be answered fully, he said. “If we had to test each possible combination in dual therapy, and counted all 13 classes, that would be 78 combinations. And if we started talking about triple therapy – which may eventually arrive – we could be talking about 286 possible combinations. So it’s just not possible to formally test the efficacy and the risk/benefit profile of every one. That means we have to start thinking about rational combinations based on mechanism of action.”

The combination of dapagliflozin and exenatide, tested in DURATION-8 is a good example, he said. “It’s rational,” because exenatide and dapagliflozin work completely independently of each other, each adding a unique method of action without overtargeting the same system and increasing the risk of adverse events.

Dapagliflozin is an inhibitor of the renal sodium-glucose cotransporter–2 (SGLT-2). This class of drugs works in the proximal renal tubule, where these glucose transporters absorb “huge amounts” of glucose, he said. “Whatever escapes there is then mopped up by the SGLT-1 cotransporters further along the nephron,” Dr. Ferrannini said. “SGLT inhibitors cause an upward and leftward shift of the relationship between plasma glucose and glycosuria for the same glomerular filtration rate.”

In the presence of an SGLT-2 inhibitor, glycosuria is increased, no matter what the plasma glucose level is. “This even takes place well within the euglycemic range, which is why these drugs cause glycosuria even in nondiabetic individuals,” Dr. Ferrannini said.

Numerous studies have shown that this class of drugs works well independently, and also pairs well with metformin, sulfonylureas, dipeptidyl peptidase–4 inhibitors, and insulin. Several studies of dapagliflozin have found that adding 10 mg to monotherapy reduced HbA_1c on the order of almost 1%, regardless of the concomitant medication.

Dapagliflozin works especially well in patients with very high HbA_{1c levels}, Dr. Ferrannini said, as shown in a 2010 dose-ranging study he led. “If the initial HbA_1c was above 10%, the drop associated with adding dapagliflozin was surprisingly large, on the order of 3%-4%,” he said Diabetes Care 2010 Oct;33(10):2217-24.

The primary response on HbA_1c is also quite durable, unlike the response seen in sulfonylureas, for example, which eventually wanes. “Every time you give this pill, you get glycosuria. It just doesn’t change,” he said.

Dapagliflozin also exerts a sustained benefit on systolic blood pressure, and causes a very consistent 2- to 3-kg decrease in body weight, no matter whether it’s given alone or with metformin, insulin, or a sulphonylurea.

But when it comes to shedding calories through urine, the body can’t be tricked forever, it seems. “You could assume very easily that body weight would continue to decline with an SGLT-2 inhibitor, but in fact it levels off after 2-3 kg. There can only be one explanation for this, and that is an increase in calorie intake. The body feels this loss of calories, particularly this massive loss of carbohydrate calories through the urine, and responds by implementing adaptive behaviors that increase calorie intake,” Dr. Ferrannini said.

In other words, hunger strikes. And strikes hard. That’s where the incretins come into play, he said.

“If we could interfere with this response that limits weight loss, we could probably continue to lose weight, and also see general improvements in HbA_1c. And a very important element of incretin action is that they restore insulin release in patients with diabetes” and moderate appetite, he said.

Incretins like exenatide, a glucagonlike peptide–1 receptor agonist, impose their weight loss effect through an entirely different system. “By delaying gastric emptying and also – more importantly – through neural signaling, they potentiate satiety, thus limiting calorie intake, reducing energy balance, and leading to a reduction in body weight,” Dr. Ferrannini said.

Therefore, using a combination like dapagliflozin and exenatide makes complete physiologic sense, he said. Both drugs improve HbA_1c, and decrease body weight and systolic blood pressure. Dapagliflozin accomplishes these tasks by increasing urinary glucose excretion, which leads to decreased vascular stiffness and better blood pressure. Exenatide works in a completely different pathway - insulin signaling - and has the additional benefit of decreasing inflammation.

The positive results of DURATION-8 support this clinical assumption, he concluded. “I would submit that combination therapy with exenatide and dapagliflozin is a rational approach, and takes advantage of the unique properties of both of these drugs,” he said.

Dr. Ferrannini has received research finding from AstraZeneca, which manufactures dapagliflozin and exenatide, as well as other companies that market diabetes drugs.

[email protected]

On Twitter @Alz_Gal

MUNICH – Enough studies exist now to support the notion of dual therapy in type 2 diabetes. But, with 13 classes of antihyperglycemic drugs approved in the United States – 7 of which are considered major – how does anyone make sense of the myriad of possible combinations?

It’s not a bad problem to have, Ele Ferrannini, MD, said shortly before the DURATION-8 data were presented at the annual meeting of the European Association for the Study of Diabetes.

“We have seen an explosion of pharmacological treatment options for type 2 diabetes in the last 20 years, which is really unprecedented, especially if we compare that to what has happened in hypertension or cardiology,” said Dr. Ferrannini of the University of Pisa (Italy). “This has given us the blessing of multiple options for treatment. But we are also now at a slight disadvantage. We all agree that we should advocate for combination treatment as early and aggressively as possible for our type 2 diabetes patients, but the question is, What combination?”

The question cannot be answered fully, he said. “If we had to test each possible combination in dual therapy, and counted all 13 classes, that would be 78 combinations. And if we started talking about triple therapy – which may eventually arrive – we could be talking about 286 possible combinations. So it’s just not possible to formally test the efficacy and the risk/benefit profile of every one. That means we have to start thinking about rational combinations based on mechanism of action.”

The combination of dapagliflozin and exenatide, tested in DURATION-8 is a good example, he said. “It’s rational,” because exenatide and dapagliflozin work completely independently of each other, each adding a unique method of action without overtargeting the same system and increasing the risk of adverse events.

Dapagliflozin is an inhibitor of the renal sodium-glucose cotransporter–2 (SGLT-2). This class of drugs works in the proximal renal tubule, where these glucose transporters absorb “huge amounts” of glucose, he said. “Whatever escapes there is then mopped up by the SGLT-1 cotransporters further along the nephron,” Dr. Ferrannini said. “SGLT inhibitors cause an upward and leftward shift of the relationship between plasma glucose and glycosuria for the same glomerular filtration rate.”

In the presence of an SGLT-2 inhibitor, glycosuria is increased, no matter what the plasma glucose level is. “This even takes place well within the euglycemic range, which is why these drugs cause glycosuria even in nondiabetic individuals,” Dr. Ferrannini said.

Numerous studies have shown that this class of drugs works well independently, and also pairs well with metformin, sulfonylureas, dipeptidyl peptidase–4 inhibitors, and insulin. Several studies of dapagliflozin have found that adding 10 mg to monotherapy reduced HbA_1c on the order of almost 1%, regardless of the concomitant medication.

Dapagliflozin works especially well in patients with very high HbA_{1c levels}, Dr. Ferrannini said, as shown in a 2010 dose-ranging study he led. “If the initial HbA_1c was above 10%, the drop associated with adding dapagliflozin was surprisingly large, on the order of 3%-4%,” he said Diabetes Care 2010 Oct;33(10):2217-24.

The primary response on HbA_1c is also quite durable, unlike the response seen in sulfonylureas, for example, which eventually wanes. “Every time you give this pill, you get glycosuria. It just doesn’t change,” he said.

Dapagliflozin also exerts a sustained benefit on systolic blood pressure, and causes a very consistent 2- to 3-kg decrease in body weight, no matter whether it’s given alone or with metformin, insulin, or a sulphonylurea.

But when it comes to shedding calories through urine, the body can’t be tricked forever, it seems. “You could assume very easily that body weight would continue to decline with an SGLT-2 inhibitor, but in fact it levels off after 2-3 kg. There can only be one explanation for this, and that is an increase in calorie intake. The body feels this loss of calories, particularly this massive loss of carbohydrate calories through the urine, and responds by implementing adaptive behaviors that increase calorie intake,” Dr. Ferrannini said.

In other words, hunger strikes. And strikes hard. That’s where the incretins come into play, he said.

“If we could interfere with this response that limits weight loss, we could probably continue to lose weight, and also see general improvements in HbA_1c. And a very important element of incretin action is that they restore insulin release in patients with diabetes” and moderate appetite, he said.

Incretins like exenatide, a glucagonlike peptide–1 receptor agonist, impose their weight loss effect through an entirely different system. “By delaying gastric emptying and also – more importantly – through neural signaling, they potentiate satiety, thus limiting calorie intake, reducing energy balance, and leading to a reduction in body weight,” Dr. Ferrannini said.

Therefore, using a combination like dapagliflozin and exenatide makes complete physiologic sense, he said. Both drugs improve HbA_1c, and decrease body weight and systolic blood pressure. Dapagliflozin accomplishes these tasks by increasing urinary glucose excretion, which leads to decreased vascular stiffness and better blood pressure. Exenatide works in a completely different pathway - insulin signaling - and has the additional benefit of decreasing inflammation.

The positive results of DURATION-8 support this clinical assumption, he concluded. “I would submit that combination therapy with exenatide and dapagliflozin is a rational approach, and takes advantage of the unique properties of both of these drugs,” he said.

Dr. Ferrannini has received research finding from AstraZeneca, which manufactures dapagliflozin and exenatide, as well as other companies that market diabetes drugs.

[email protected]

On Twitter @Alz_Gal

MUNICH – Enough studies exist now to support the notion of dual therapy in type 2 diabetes. But, with 13 classes of antihyperglycemic drugs approved in the United States – 7 of which are considered major – how does anyone make sense of the myriad of possible combinations?

It’s not a bad problem to have, Ele Ferrannini, MD, said shortly before the DURATION-8 data were presented at the annual meeting of the European Association for the Study of Diabetes.

“We have seen an explosion of pharmacological treatment options for type 2 diabetes in the last 20 years, which is really unprecedented, especially if we compare that to what has happened in hypertension or cardiology,” said Dr. Ferrannini of the University of Pisa (Italy). “This has given us the blessing of multiple options for treatment. But we are also now at a slight disadvantage. We all agree that we should advocate for combination treatment as early and aggressively as possible for our type 2 diabetes patients, but the question is, What combination?”

The question cannot be answered fully, he said. “If we had to test each possible combination in dual therapy, and counted all 13 classes, that would be 78 combinations. And if we started talking about triple therapy – which may eventually arrive – we could be talking about 286 possible combinations. So it’s just not possible to formally test the efficacy and the risk/benefit profile of every one. That means we have to start thinking about rational combinations based on mechanism of action.”

The combination of dapagliflozin and exenatide, tested in DURATION-8 is a good example, he said. “It’s rational,” because exenatide and dapagliflozin work completely independently of each other, each adding a unique method of action without overtargeting the same system and increasing the risk of adverse events.

Dapagliflozin is an inhibitor of the renal sodium-glucose cotransporter–2 (SGLT-2). This class of drugs works in the proximal renal tubule, where these glucose transporters absorb “huge amounts” of glucose, he said. “Whatever escapes there is then mopped up by the SGLT-1 cotransporters further along the nephron,” Dr. Ferrannini said. “SGLT inhibitors cause an upward and leftward shift of the relationship between plasma glucose and glycosuria for the same glomerular filtration rate.”

In the presence of an SGLT-2 inhibitor, glycosuria is increased, no matter what the plasma glucose level is. “This even takes place well within the euglycemic range, which is why these drugs cause glycosuria even in nondiabetic individuals,” Dr. Ferrannini said.

Numerous studies have shown that this class of drugs works well independently, and also pairs well with metformin, sulfonylureas, dipeptidyl peptidase–4 inhibitors, and insulin. Several studies of dapagliflozin have found that adding 10 mg to monotherapy reduced HbA_1c on the order of almost 1%, regardless of the concomitant medication.

Dapagliflozin works especially well in patients with very high HbA_{1c levels}, Dr. Ferrannini said, as shown in a 2010 dose-ranging study he led. “If the initial HbA_1c was above 10%, the drop associated with adding dapagliflozin was surprisingly large, on the order of 3%-4%,” he said Diabetes Care 2010 Oct;33(10):2217-24.

The primary response on HbA_1c is also quite durable, unlike the response seen in sulfonylureas, for example, which eventually wanes. “Every time you give this pill, you get glycosuria. It just doesn’t change,” he said.

Dapagliflozin also exerts a sustained benefit on systolic blood pressure, and causes a very consistent 2- to 3-kg decrease in body weight, no matter whether it’s given alone or with metformin, insulin, or a sulphonylurea.

But when it comes to shedding calories through urine, the body can’t be tricked forever, it seems. “You could assume very easily that body weight would continue to decline with an SGLT-2 inhibitor, but in fact it levels off after 2-3 kg. There can only be one explanation for this, and that is an increase in calorie intake. The body feels this loss of calories, particularly this massive loss of carbohydrate calories through the urine, and responds by implementing adaptive behaviors that increase calorie intake,” Dr. Ferrannini said.

In other words, hunger strikes. And strikes hard. That’s where the incretins come into play, he said.

“If we could interfere with this response that limits weight loss, we could probably continue to lose weight, and also see general improvements in HbA_1c. And a very important element of incretin action is that they restore insulin release in patients with diabetes” and moderate appetite, he said.

Incretins like exenatide, a glucagonlike peptide–1 receptor agonist, impose their weight loss effect through an entirely different system. “By delaying gastric emptying and also – more importantly – through neural signaling, they potentiate satiety, thus limiting calorie intake, reducing energy balance, and leading to a reduction in body weight,” Dr. Ferrannini said.

Therefore, using a combination like dapagliflozin and exenatide makes complete physiologic sense, he said. Both drugs improve HbA_1c, and decrease body weight and systolic blood pressure. Dapagliflozin accomplishes these tasks by increasing urinary glucose excretion, which leads to decreased vascular stiffness and better blood pressure. Exenatide works in a completely different pathway - insulin signaling - and has the additional benefit of decreasing inflammation.

The positive results of DURATION-8 support this clinical assumption, he concluded. “I would submit that combination therapy with exenatide and dapagliflozin is a rational approach, and takes advantage of the unique properties of both of these drugs,” he said.

Dr. Ferrannini has received research finding from AstraZeneca, which manufactures dapagliflozin and exenatide, as well as other companies that market diabetes drugs.

[email protected]

On Twitter @Alz_Gal

Decisions in popliteal or below-knee atherectomy can be complicated by a wide array of devices and lesion types.

Limited data on the long-term durability of interventions, or direct comparisons of approaches, can also complicate the decision-making process, as do cost concerns.

In his Sunday, September 18 talk at VIVA, titled “Popliteal and Below-the-Knee Atherectomy – Which Tool in Which Circumstance and When Not to Bother,” James F. McKinsey, MD, aims to help clinicians navigate this quickly changing field, with updates on emerging technologies.

Directional atherectomy and laser devices continue to undergo innovation, with new devices introduced almost annually. The changing device picture can be confusing, acknowledged Dr. McKinsey of Mt. Sinai Health System in New York. “I am well versed with many of them because I have a high volume. But people with just a few cases a month may not be,” he said.

Lower volume practitioners “need to find at least one, if not two, devices that they are going to be comfortable with,” Dr. McKinsey said, noting that each is associated with a special technique and may require additional support or set-up costs, such as a laser box or a generator. “And it becomes a question of how many different things can you have on the shelf?”

Dr. McKinsey said his talk is aimed at helping practitioners decide which lesions to treat, and with which device – with close attention to the morphological characteristics of lesions. “It’s almost like an algorithm,” he said.

Increasingly, he noted, lower-limb atherectomy is being approached with more than one technique. There is a strong practice trend toward combining atherectomy with drug-coated balloon therapy, he said. “I think the idea of leaving nothing behind [in the vessel] before you do a drug-coated balloon has gotten much more support. People are coming in now and saying they want to prepare the artery by debulking it, then come back and do DCB.” A new rotational laser device, he says, has particular promise in combination with DCBs.

But combining approaches means cost increases at a time when “reimbursement is going down and the product costs and associated expenses are going up,” he said.

Also on the horizon is another, potentially game-changing technology: bioabsorbable stents. While these fall outside the scope of his talk, Dr. McKinsey said he’s assisted a number of lower-limb procedures in Europe this year using them. The technology is especially promising for “more complicated, more calcified lesions,” he said. “In Europe it is being used fairly extensively,” he noted, and likely to come online in the United States within a year or so.

As with the combined approaches, the introduction of drug-eluting bioabsorbable stents into the treatment of lower-limb lesions is also likely to incur high costs, Dr. McKinsey noted. What’s needed are longer-term studies that follow patients up to 5 years, to understand whether high upfront costs are offset by later benefits.

“We have to look at is not necessarily the cost of doing a case, but the cost of treating that patient. We may have a greater upfront cost, but if the intervention has greater durability, and the patient doesn’t have a repeat procedure, then society and healthcare providers do better,” he said.

Decisions in popliteal or below-knee atherectomy can be complicated by a wide array of devices and lesion types.

Limited data on the long-term durability of interventions, or direct comparisons of approaches, can also complicate the decision-making process, as do cost concerns.

In his Sunday, September 18 talk at VIVA, titled “Popliteal and Below-the-Knee Atherectomy – Which Tool in Which Circumstance and When Not to Bother,” James F. McKinsey, MD, aims to help clinicians navigate this quickly changing field, with updates on emerging technologies.

Directional atherectomy and laser devices continue to undergo innovation, with new devices introduced almost annually. The changing device picture can be confusing, acknowledged Dr. McKinsey of Mt. Sinai Health System in New York. “I am well versed with many of them because I have a high volume. But people with just a few cases a month may not be,” he said.

Lower volume practitioners “need to find at least one, if not two, devices that they are going to be comfortable with,” Dr. McKinsey said, noting that each is associated with a special technique and may require additional support or set-up costs, such as a laser box or a generator. “And it becomes a question of how many different things can you have on the shelf?”

Dr. McKinsey said his talk is aimed at helping practitioners decide which lesions to treat, and with which device – with close attention to the morphological characteristics of lesions. “It’s almost like an algorithm,” he said.

Increasingly, he noted, lower-limb atherectomy is being approached with more than one technique. There is a strong practice trend toward combining atherectomy with drug-coated balloon therapy, he said. “I think the idea of leaving nothing behind [in the vessel] before you do a drug-coated balloon has gotten much more support. People are coming in now and saying they want to prepare the artery by debulking it, then come back and do DCB.” A new rotational laser device, he says, has particular promise in combination with DCBs.

But combining approaches means cost increases at a time when “reimbursement is going down and the product costs and associated expenses are going up,” he said.

Also on the horizon is another, potentially game-changing technology: bioabsorbable stents. While these fall outside the scope of his talk, Dr. McKinsey said he’s assisted a number of lower-limb procedures in Europe this year using them. The technology is especially promising for “more complicated, more calcified lesions,” he said. “In Europe it is being used fairly extensively,” he noted, and likely to come online in the United States within a year or so.

As with the combined approaches, the introduction of drug-eluting bioabsorbable stents into the treatment of lower-limb lesions is also likely to incur high costs, Dr. McKinsey noted. What’s needed are longer-term studies that follow patients up to 5 years, to understand whether high upfront costs are offset by later benefits.

“We have to look at is not necessarily the cost of doing a case, but the cost of treating that patient. We may have a greater upfront cost, but if the intervention has greater durability, and the patient doesn’t have a repeat procedure, then society and healthcare providers do better,” he said.

Decisions in popliteal or below-knee atherectomy can be complicated by a wide array of devices and lesion types.

Limited data on the long-term durability of interventions, or direct comparisons of approaches, can also complicate the decision-making process, as do cost concerns.

In his Sunday, September 18 talk at VIVA, titled “Popliteal and Below-the-Knee Atherectomy – Which Tool in Which Circumstance and When Not to Bother,” James F. McKinsey, MD, aims to help clinicians navigate this quickly changing field, with updates on emerging technologies.

Directional atherectomy and laser devices continue to undergo innovation, with new devices introduced almost annually. The changing device picture can be confusing, acknowledged Dr. McKinsey of Mt. Sinai Health System in New York. “I am well versed with many of them because I have a high volume. But people with just a few cases a month may not be,” he said.

Lower volume practitioners “need to find at least one, if not two, devices that they are going to be comfortable with,” Dr. McKinsey said, noting that each is associated with a special technique and may require additional support or set-up costs, such as a laser box or a generator. “And it becomes a question of how many different things can you have on the shelf?”

Dr. McKinsey said his talk is aimed at helping practitioners decide which lesions to treat, and with which device – with close attention to the morphological characteristics of lesions. “It’s almost like an algorithm,” he said.

Increasingly, he noted, lower-limb atherectomy is being approached with more than one technique. There is a strong practice trend toward combining atherectomy with drug-coated balloon therapy, he said. “I think the idea of leaving nothing behind [in the vessel] before you do a drug-coated balloon has gotten much more support. People are coming in now and saying they want to prepare the artery by debulking it, then come back and do DCB.” A new rotational laser device, he says, has particular promise in combination with DCBs.

But combining approaches means cost increases at a time when “reimbursement is going down and the product costs and associated expenses are going up,” he said.

Also on the horizon is another, potentially game-changing technology: bioabsorbable stents. While these fall outside the scope of his talk, Dr. McKinsey said he’s assisted a number of lower-limb procedures in Europe this year using them. The technology is especially promising for “more complicated, more calcified lesions,” he said. “In Europe it is being used fairly extensively,” he noted, and likely to come online in the United States within a year or so.

As with the combined approaches, the introduction of drug-eluting bioabsorbable stents into the treatment of lower-limb lesions is also likely to incur high costs, Dr. McKinsey noted. What’s needed are longer-term studies that follow patients up to 5 years, to understand whether high upfront costs are offset by later benefits.

“We have to look at is not necessarily the cost of doing a case, but the cost of treating that patient. We may have a greater upfront cost, but if the intervention has greater durability, and the patient doesn’t have a repeat procedure, then society and healthcare providers do better,” he said.

There was no significant difference in serious infection and mortality rates between mycophenolate mofetil (MMF), azathioprine (AZA), and cyclophosphamide (CYC) for high-risk systemic lupus erythematosus patients who were newly initiating immunotherapy, according to Candace H. Feldman, MD, and her associates.

In a 6-month analysis of 1,350 systemic lupus erythematosus patients initiating MMF and 1,350 patients initiating AZA, the incidence rate of first hospitalized infection per 100 person-years for MMF users was 14.6, and the incidence rate for AZA was 15.2. In a separate 6-month analysis of 674 patients initiating MMF and 674 patients receiving CYC, the incidence rate of first hospitalized infection per 100 person-years was 24.1 for MMF and 24.6 for CYC. The hazard ratio for AZA was 0.99, and for CYC it was 0.95.

Mortality was also similar in both cohorts. In the MMF vs. AZA cohort, 13 deaths were reported in the MMF group, and 14 were reported in the AZA group. In the MMF vs. CYC cohort, 15 deaths were reported in each group. The hazard ratio for mortality in the AZA group was 0.90, and the HR for mortality in the CYC group was 0.95.

“Based on these findings, concerns about differential infection risks may not need to influence physician and patient choice between MMF vs. AZA and MMF vs. CYC, even in a population highly susceptible to adverse outcomes,” the investigators concluded.

Find the full study in Arthritis & Rheumatology (doi: 10.1002/art.39849).

[email protected]

There was no significant difference in serious infection and mortality rates between mycophenolate mofetil (MMF), azathioprine (AZA), and cyclophosphamide (CYC) for high-risk systemic lupus erythematosus patients who were newly initiating immunotherapy, according to Candace H. Feldman, MD, and her associates.

In a 6-month analysis of 1,350 systemic lupus erythematosus patients initiating MMF and 1,350 patients initiating AZA, the incidence rate of first hospitalized infection per 100 person-years for MMF users was 14.6, and the incidence rate for AZA was 15.2. In a separate 6-month analysis of 674 patients initiating MMF and 674 patients receiving CYC, the incidence rate of first hospitalized infection per 100 person-years was 24.1 for MMF and 24.6 for CYC. The hazard ratio for AZA was 0.99, and for CYC it was 0.95.

Mortality was also similar in both cohorts. In the MMF vs. AZA cohort, 13 deaths were reported in the MMF group, and 14 were reported in the AZA group. In the MMF vs. CYC cohort, 15 deaths were reported in each group. The hazard ratio for mortality in the AZA group was 0.90, and the HR for mortality in the CYC group was 0.95.

“Based on these findings, concerns about differential infection risks may not need to influence physician and patient choice between MMF vs. AZA and MMF vs. CYC, even in a population highly susceptible to adverse outcomes,” the investigators concluded.

Find the full study in Arthritis & Rheumatology (doi: 10.1002/art.39849).

[email protected]

There was no significant difference in serious infection and mortality rates between mycophenolate mofetil (MMF), azathioprine (AZA), and cyclophosphamide (CYC) for high-risk systemic lupus erythematosus patients who were newly initiating immunotherapy, according to Candace H. Feldman, MD, and her associates.

In a 6-month analysis of 1,350 systemic lupus erythematosus patients initiating MMF and 1,350 patients initiating AZA, the incidence rate of first hospitalized infection per 100 person-years for MMF users was 14.6, and the incidence rate for AZA was 15.2. In a separate 6-month analysis of 674 patients initiating MMF and 674 patients receiving CYC, the incidence rate of first hospitalized infection per 100 person-years was 24.1 for MMF and 24.6 for CYC. The hazard ratio for AZA was 0.99, and for CYC it was 0.95.

Mortality was also similar in both cohorts. In the MMF vs. AZA cohort, 13 deaths were reported in the MMF group, and 14 were reported in the AZA group. In the MMF vs. CYC cohort, 15 deaths were reported in each group. The hazard ratio for mortality in the AZA group was 0.90, and the HR for mortality in the CYC group was 0.95.

“Based on these findings, concerns about differential infection risks may not need to influence physician and patient choice between MMF vs. AZA and MMF vs. CYC, even in a population highly susceptible to adverse outcomes,” the investigators concluded.

Find the full study in Arthritis & Rheumatology (doi: 10.1002/art.39849).

[email protected]