Sherry Boschert

Major Finding: Using MRI to decide which patients with stroke of unclear onset should get treatment produced outcomes similar to those for patients with known onset at centers experienced in thrombolysis for unclear-onset stroke.

Data Source: Prospective study of 430 patients with unclear-onset stroke at six university hospitals in South Korea.

Disclosures: The investigators reported having no relevant conflicts of interest.

LOS ANGELES — Physicians may have moved one step closer to identifying patients with stroke of unclear onset who might benefit from treatment, a prospective multicenter study suggests.

About 25% of ischemic strokes occur in people who don't know, or are unable to communicate, when their stroke began. Guidelines call for intravenous thrombolysis to be given within 4.5 hours of symptom onset, and patients with unclear-onset stroke traditionally have been excluded from thrombolytic therapy.

The study of 430 patients with unclear-onset stroke showed that basing treatment on MRI evaluation is feasible, with safety and efficacy similar to what was seen in pivotal trials of thrombolytic therapy, Dr. Dong-Wha Kang said at the meeting. The current study lacked a control group of comparable patients who did not receive therapy, however, making the true effect of treatment in these patients difficult to assess.

The 10 patients who were treated at two centers with little previous experience in thrombolysis for unclear-onset stroke were 11 times more likely to have poor clinical outcomes than were the patients treated at four centers where interventionists already had been selecting patients empirically for treatment of unclear-onset stroke. This difference in clinical outcomes “might be related to the expertise or the skill of the interventionists,” Dr. Kang said at the meeting, sponsored by the American Heart Association.

He and his associates screened consecutive patients with unclear-onset stroke who presented at six university hospitals in South Korea within 6 hours of symptom detection. They used multimodal MRI to look for sizable areas with live brain tissue despite lack of blood flow, and to exclude patients from therapy who were at higher risk of serious bleeding from thrombolytic therapy or who were past the time of tissue death.

Patients qualified for reperfusion therapy if MRI findings showed the presence of greater than a 20% perfusion-diffusion mismatch, absence of extensive early infarct (with “extensive” defined as infarct in more than a third of middle cerebral artery territory) on diffusion-weighted imaging, and absence of well-developed parenchymal hyperintensity on fluid-attenuated inversion-recovery (FLAIR) imaging or T2 images.

A total of 83 patients (19% of the cohort) received reperfusion therapy, which included IV tissue plasminogen activator (tPA) with or without intra-arterial urokinase within 3 hours, or intra-arterial urokinase within 6 hours from symptom detection. (Urokinase is approved in Korea but not in the United States.) The study also allowed mechanical clot disruption or stenting. In all, 57 patients were treated using an endovascular approach (69%), 9 patients were treated with IV tPA only (11%), and both approaches were used in 17 patients (21%). (Percentages were rounded.)

In the 83 patients who underwent reperfusion therapy, 37 had a good clinical outcome (45%), defined as a score of 0–2 on the modified Rankin scale at 3-month follow-up, reported Dr. Kang of the University of Ulsan, Seoul, South Korea, and 24 patients (29%) had excellent clinical outcomes.

Eight patients developed symptomatic intracranial hemorrhage, five with neurological decline (6%) and three with at least a four-point increase in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours after treatment.

Poor clinical outcomes were nine times more likely in women than in men and 11% more likely in patients with higher baseline NIHSS scores. The treated patients had a mean age of 67 years and a median baseline NIHSS score of 14.

The investigators compared the clinical results with separate data from 156 similar patients whose stroke onset times were known. The percentage of patients who had good outcomes did not differ significantly between those groups, he said.

Large perfusion-diffusion mismatch and no FLAIR changes within a DWI lesion made this patient a good candidate for treatment.

Source Courtesy Dr. Dong-Wha Kang

Major Finding: Using MRI to decide which patients with stroke of unclear onset should get treatment produced outcomes similar to those for patients with known onset at centers experienced in thrombolysis for unclear-onset stroke.

Data Source: Prospective study of 430 patients with unclear-onset stroke at six university hospitals in South Korea.

Disclosures: The investigators reported having no relevant conflicts of interest.

LOS ANGELES — Physicians may have moved one step closer to identifying patients with stroke of unclear onset who might benefit from treatment, a prospective multicenter study suggests.

About 25% of ischemic strokes occur in people who don't know, or are unable to communicate, when their stroke began. Guidelines call for intravenous thrombolysis to be given within 4.5 hours of symptom onset, and patients with unclear-onset stroke traditionally have been excluded from thrombolytic therapy.

The study of 430 patients with unclear-onset stroke showed that basing treatment on MRI evaluation is feasible, with safety and efficacy similar to what was seen in pivotal trials of thrombolytic therapy, Dr. Dong-Wha Kang said at the meeting. The current study lacked a control group of comparable patients who did not receive therapy, however, making the true effect of treatment in these patients difficult to assess.

The 10 patients who were treated at two centers with little previous experience in thrombolysis for unclear-onset stroke were 11 times more likely to have poor clinical outcomes than were the patients treated at four centers where interventionists already had been selecting patients empirically for treatment of unclear-onset stroke. This difference in clinical outcomes “might be related to the expertise or the skill of the interventionists,” Dr. Kang said at the meeting, sponsored by the American Heart Association.

He and his associates screened consecutive patients with unclear-onset stroke who presented at six university hospitals in South Korea within 6 hours of symptom detection. They used multimodal MRI to look for sizable areas with live brain tissue despite lack of blood flow, and to exclude patients from therapy who were at higher risk of serious bleeding from thrombolytic therapy or who were past the time of tissue death.

Patients qualified for reperfusion therapy if MRI findings showed the presence of greater than a 20% perfusion-diffusion mismatch, absence of extensive early infarct (with “extensive” defined as infarct in more than a third of middle cerebral artery territory) on diffusion-weighted imaging, and absence of well-developed parenchymal hyperintensity on fluid-attenuated inversion-recovery (FLAIR) imaging or T2 images.

A total of 83 patients (19% of the cohort) received reperfusion therapy, which included IV tissue plasminogen activator (tPA) with or without intra-arterial urokinase within 3 hours, or intra-arterial urokinase within 6 hours from symptom detection. (Urokinase is approved in Korea but not in the United States.) The study also allowed mechanical clot disruption or stenting. In all, 57 patients were treated using an endovascular approach (69%), 9 patients were treated with IV tPA only (11%), and both approaches were used in 17 patients (21%). (Percentages were rounded.)

In the 83 patients who underwent reperfusion therapy, 37 had a good clinical outcome (45%), defined as a score of 0–2 on the modified Rankin scale at 3-month follow-up, reported Dr. Kang of the University of Ulsan, Seoul, South Korea, and 24 patients (29%) had excellent clinical outcomes.

Eight patients developed symptomatic intracranial hemorrhage, five with neurological decline (6%) and three with at least a four-point increase in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours after treatment.

Poor clinical outcomes were nine times more likely in women than in men and 11% more likely in patients with higher baseline NIHSS scores. The treated patients had a mean age of 67 years and a median baseline NIHSS score of 14.

The investigators compared the clinical results with separate data from 156 similar patients whose stroke onset times were known. The percentage of patients who had good outcomes did not differ significantly between those groups, he said.

Large perfusion-diffusion mismatch and no FLAIR changes within a DWI lesion made this patient a good candidate for treatment.

Source Courtesy Dr. Dong-Wha Kang

Major Finding: Using MRI to decide which patients with stroke of unclear onset should get treatment produced outcomes similar to those for patients with known onset at centers experienced in thrombolysis for unclear-onset stroke.

Data Source: Prospective study of 430 patients with unclear-onset stroke at six university hospitals in South Korea.

Disclosures: The investigators reported having no relevant conflicts of interest.

LOS ANGELES — Physicians may have moved one step closer to identifying patients with stroke of unclear onset who might benefit from treatment, a prospective multicenter study suggests.

About 25% of ischemic strokes occur in people who don't know, or are unable to communicate, when their stroke began. Guidelines call for intravenous thrombolysis to be given within 4.5 hours of symptom onset, and patients with unclear-onset stroke traditionally have been excluded from thrombolytic therapy.

The study of 430 patients with unclear-onset stroke showed that basing treatment on MRI evaluation is feasible, with safety and efficacy similar to what was seen in pivotal trials of thrombolytic therapy, Dr. Dong-Wha Kang said at the meeting. The current study lacked a control group of comparable patients who did not receive therapy, however, making the true effect of treatment in these patients difficult to assess.

The 10 patients who were treated at two centers with little previous experience in thrombolysis for unclear-onset stroke were 11 times more likely to have poor clinical outcomes than were the patients treated at four centers where interventionists already had been selecting patients empirically for treatment of unclear-onset stroke. This difference in clinical outcomes “might be related to the expertise or the skill of the interventionists,” Dr. Kang said at the meeting, sponsored by the American Heart Association.

He and his associates screened consecutive patients with unclear-onset stroke who presented at six university hospitals in South Korea within 6 hours of symptom detection. They used multimodal MRI to look for sizable areas with live brain tissue despite lack of blood flow, and to exclude patients from therapy who were at higher risk of serious bleeding from thrombolytic therapy or who were past the time of tissue death.

Patients qualified for reperfusion therapy if MRI findings showed the presence of greater than a 20% perfusion-diffusion mismatch, absence of extensive early infarct (with “extensive” defined as infarct in more than a third of middle cerebral artery territory) on diffusion-weighted imaging, and absence of well-developed parenchymal hyperintensity on fluid-attenuated inversion-recovery (FLAIR) imaging or T2 images.

A total of 83 patients (19% of the cohort) received reperfusion therapy, which included IV tissue plasminogen activator (tPA) with or without intra-arterial urokinase within 3 hours, or intra-arterial urokinase within 6 hours from symptom detection. (Urokinase is approved in Korea but not in the United States.) The study also allowed mechanical clot disruption or stenting. In all, 57 patients were treated using an endovascular approach (69%), 9 patients were treated with IV tPA only (11%), and both approaches were used in 17 patients (21%). (Percentages were rounded.)

In the 83 patients who underwent reperfusion therapy, 37 had a good clinical outcome (45%), defined as a score of 0–2 on the modified Rankin scale at 3-month follow-up, reported Dr. Kang of the University of Ulsan, Seoul, South Korea, and 24 patients (29%) had excellent clinical outcomes.

Eight patients developed symptomatic intracranial hemorrhage, five with neurological decline (6%) and three with at least a four-point increase in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours after treatment.

Poor clinical outcomes were nine times more likely in women than in men and 11% more likely in patients with higher baseline NIHSS scores. The treated patients had a mean age of 67 years and a median baseline NIHSS score of 14.

The investigators compared the clinical results with separate data from 156 similar patients whose stroke onset times were known. The percentage of patients who had good outcomes did not differ significantly between those groups, he said.

Large perfusion-diffusion mismatch and no FLAIR changes within a DWI lesion made this patient a good candidate for treatment.

Source Courtesy Dr. Dong-Wha Kang

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It’s not a fast car, it’s not a flashy car, but it’s a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Photo credit: Thomas Doerfer/Wikimedia Commons

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you’re doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you’re probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver’s tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It’s "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It’s not a fast car, it’s not a flashy car, but it’s a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Photo credit: Thomas Doerfer/Wikimedia Commons

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you’re doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you’re probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver’s tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It’s "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It’s not a fast car, it’s not a flashy car, but it’s a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Photo credit: Thomas Doerfer/Wikimedia Commons

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you’re doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you’re probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver’s tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It’s "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It’s not a fast car, it’s not a flashy car, but it’s a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Photo credit: Thomas Doerfer/Wikimedia Commons

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you’re doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you’re probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver’s tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It’s "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It’s not a fast car, it’s not a flashy car, but it’s a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Photo credit: Thomas Doerfer/Wikimedia Commons

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you’re doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you’re probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver’s tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It’s "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It’s not a fast car, it’s not a flashy car, but it’s a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Photo credit: Thomas Doerfer/Wikimedia Commons

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you’re doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you’re probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver’s tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It’s "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It's not a fast car, it's not a flashy car, but it's a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you're doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you're probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver's tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It's "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It's not a fast car, it's not a flashy car, but it's a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you're doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you're probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver's tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It's "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It's not a fast car, it's not a flashy car, but it's a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you're doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you're probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver's tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It's "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

The American Society of Clinical Oncology has revised its guidelines on care of bone metastases in metastatic breast cancer to reflect expanded treatment options as well as concern about osteonecrosis of the jaw, a rare but serious side effect.

The new guideline, released Feb. 22, on the role of "bone modifying agents" are the first to include denosumab (Xgeva), a monoclonal antibody approved in 2010 that targets the receptor activator of nuclear factor-kappa beta ligand (RANKL). They also address use of the bisphosphonates pamidronate (Aredia) and zoledronic acid (Zometa), two other agents previously available in the United States.

"There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another," according to the expert panel that updated the guidelines. It noted that two other bisphosphonates, ibandronate (Boniva) and clodronate, are not approved in the United States for patients with breast cancer that has metastasized to the bone, and therefore not addressed in the new guidelines.

The panel said it replaced the term bisphosphonates with "bone-modifying agents" in the name of the guidelines in order to be able to incorporate data on new types of agents, including osteoclast inhibitors, in future updates.

The "Updated Guideline on the Role of Bone-Modifying Agents in the Prevention and Treatment of Bone Metastases in Patients with Metastatic Breast Cancer" will be published soon in the Journal of Clinical Oncology, but is available for free online (pdf).

The recommendations include, also for the first time, advice regarding osteonecrosis of the jaw, a rare but potentially disastrous complication of therapy with bone-modifying agents that was recognized after publication of the 2003 guidelines (J. of Clin. Oncol. 2003;21:4042-4057). Before starting a bone-modifying agent, a patient should get a dental examination and receive preventive dentistry care, the panel recommends.

Bone-modifying agents should be used only in patients with breast cancer with evidence of bone metastases, the updated guideline states. Patients without bone metastases should not receive the drugs unless they are in a clinical trial. Diagnoses of bone metastases must by confirmed by X-ray, CT or MRI, and not rely on an abnormal bone scan to qualify for treatment.

Clinicians should start bone-modifying agents as soon as patients with metastatic breast cancer develop cancer bone pain, and should provide pain management.

There wasn’t enough evidence to recommend one agent over another. Two are given by IV and one subcutaneously. Recommended dosages are 120 mg subcutaneous denosumab every 4 weeks, or IV pamidronate 90 mg over no less than 2 hours every 3-4 weeks, or IV zoledronic acid 4 mg over no less than 15 minutes every 3-4 weeks, with no new data to support any changes from the last guideline.

Biochemical markers should not be used to monitor the effectiveness of bone-modifying agents except in clinical trials, the guideline states.

Data since 2003 on the effects of bisphosphonates on kidney function led to new recommendations on monitoring patients. No change in dosage, infusion time, or interval is needed for patients with creatinine clearance greater than 60 mL/minute. Clinicians should monitor the creatinine level with each IV bisphosphonate dose. When giving denosumab to patients with creatinine clearance less than 30 mL/minute or who are on dialysis, closely monitor for hypocalcemia, the guideline states.

Amgen, which markets denosumab, has provided payments for consulting, advising, or research to Dr. Catherine Van Poznak, co-chair of the guidelines panel, and to two other panelists. Dr. Van Poznak has received payments for consulting, advising, or research for Amgen, which markets denosumab and has received research funding from Novartis, which markets pamidronate and zoledronic acid. Dr. Von Roenn, co-chair of the guidelines panel, declared having no conflicts of interest. Two other panelists have been consultants, advisors, or recipients of honoraria from Roche or Abraxis BioScience.

The American Society of Clinical Oncology has revised its guidelines on care of bone metastases in metastatic breast cancer to reflect expanded treatment options as well as concern about osteonecrosis of the jaw, a rare but serious side effect.

The new guideline, released Feb. 22, on the role of "bone modifying agents" are the first to include denosumab (Xgeva), a monoclonal antibody approved in 2010 that targets the receptor activator of nuclear factor-kappa beta ligand (RANKL). They also address use of the bisphosphonates pamidronate (Aredia) and zoledronic acid (Zometa), two other agents previously available in the United States.

"There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another," according to the expert panel that updated the guidelines. It noted that two other bisphosphonates, ibandronate (Boniva) and clodronate, are not approved in the United States for patients with breast cancer that has metastasized to the bone, and therefore not addressed in the new guidelines.

The panel said it replaced the term bisphosphonates with "bone-modifying agents" in the name of the guidelines in order to be able to incorporate data on new types of agents, including osteoclast inhibitors, in future updates.

The "Updated Guideline on the Role of Bone-Modifying Agents in the Prevention and Treatment of Bone Metastases in Patients with Metastatic Breast Cancer" will be published soon in the Journal of Clinical Oncology, but is available for free online (pdf).

The recommendations include, also for the first time, advice regarding osteonecrosis of the jaw, a rare but potentially disastrous complication of therapy with bone-modifying agents that was recognized after publication of the 2003 guidelines (J. of Clin. Oncol. 2003;21:4042-4057). Before starting a bone-modifying agent, a patient should get a dental examination and receive preventive dentistry care, the panel recommends.

Bone-modifying agents should be used only in patients with breast cancer with evidence of bone metastases, the updated guideline states. Patients without bone metastases should not receive the drugs unless they are in a clinical trial. Diagnoses of bone metastases must by confirmed by X-ray, CT or MRI, and not rely on an abnormal bone scan to qualify for treatment.

Clinicians should start bone-modifying agents as soon as patients with metastatic breast cancer develop cancer bone pain, and should provide pain management.

There wasn’t enough evidence to recommend one agent over another. Two are given by IV and one subcutaneously. Recommended dosages are 120 mg subcutaneous denosumab every 4 weeks, or IV pamidronate 90 mg over no less than 2 hours every 3-4 weeks, or IV zoledronic acid 4 mg over no less than 15 minutes every 3-4 weeks, with no new data to support any changes from the last guideline.

Biochemical markers should not be used to monitor the effectiveness of bone-modifying agents except in clinical trials, the guideline states.

Data since 2003 on the effects of bisphosphonates on kidney function led to new recommendations on monitoring patients. No change in dosage, infusion time, or interval is needed for patients with creatinine clearance greater than 60 mL/minute. Clinicians should monitor the creatinine level with each IV bisphosphonate dose. When giving denosumab to patients with creatinine clearance less than 30 mL/minute or who are on dialysis, closely monitor for hypocalcemia, the guideline states.

Amgen, which markets denosumab, has provided payments for consulting, advising, or research to Dr. Catherine Van Poznak, co-chair of the guidelines panel, and to two other panelists. Dr. Van Poznak has received payments for consulting, advising, or research for Amgen, which markets denosumab and has received research funding from Novartis, which markets pamidronate and zoledronic acid. Dr. Von Roenn, co-chair of the guidelines panel, declared having no conflicts of interest. Two other panelists have been consultants, advisors, or recipients of honoraria from Roche or Abraxis BioScience.

The American Society of Clinical Oncology has revised its guidelines on care of bone metastases in metastatic breast cancer to reflect expanded treatment options as well as concern about osteonecrosis of the jaw, a rare but serious side effect.

The new guideline, released Feb. 22, on the role of "bone modifying agents" are the first to include denosumab (Xgeva), a monoclonal antibody approved in 2010 that targets the receptor activator of nuclear factor-kappa beta ligand (RANKL). They also address use of the bisphosphonates pamidronate (Aredia) and zoledronic acid (Zometa), two other agents previously available in the United States.

"There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another," according to the expert panel that updated the guidelines. It noted that two other bisphosphonates, ibandronate (Boniva) and clodronate, are not approved in the United States for patients with breast cancer that has metastasized to the bone, and therefore not addressed in the new guidelines.

The panel said it replaced the term bisphosphonates with "bone-modifying agents" in the name of the guidelines in order to be able to incorporate data on new types of agents, including osteoclast inhibitors, in future updates.

The "Updated Guideline on the Role of Bone-Modifying Agents in the Prevention and Treatment of Bone Metastases in Patients with Metastatic Breast Cancer" will be published soon in the Journal of Clinical Oncology, but is available for free online (pdf).

The recommendations include, also for the first time, advice regarding osteonecrosis of the jaw, a rare but potentially disastrous complication of therapy with bone-modifying agents that was recognized after publication of the 2003 guidelines (J. of Clin. Oncol. 2003;21:4042-4057). Before starting a bone-modifying agent, a patient should get a dental examination and receive preventive dentistry care, the panel recommends.

Bone-modifying agents should be used only in patients with breast cancer with evidence of bone metastases, the updated guideline states. Patients without bone metastases should not receive the drugs unless they are in a clinical trial. Diagnoses of bone metastases must by confirmed by X-ray, CT or MRI, and not rely on an abnormal bone scan to qualify for treatment.

Clinicians should start bone-modifying agents as soon as patients with metastatic breast cancer develop cancer bone pain, and should provide pain management.

There wasn’t enough evidence to recommend one agent over another. Two are given by IV and one subcutaneously. Recommended dosages are 120 mg subcutaneous denosumab every 4 weeks, or IV pamidronate 90 mg over no less than 2 hours every 3-4 weeks, or IV zoledronic acid 4 mg over no less than 15 minutes every 3-4 weeks, with no new data to support any changes from the last guideline.

Biochemical markers should not be used to monitor the effectiveness of bone-modifying agents except in clinical trials, the guideline states.

Data since 2003 on the effects of bisphosphonates on kidney function led to new recommendations on monitoring patients. No change in dosage, infusion time, or interval is needed for patients with creatinine clearance greater than 60 mL/minute. Clinicians should monitor the creatinine level with each IV bisphosphonate dose. When giving denosumab to patients with creatinine clearance less than 30 mL/minute or who are on dialysis, closely monitor for hypocalcemia, the guideline states.

Amgen, which markets denosumab, has provided payments for consulting, advising, or research to Dr. Catherine Van Poznak, co-chair of the guidelines panel, and to two other panelists. Dr. Van Poznak has received payments for consulting, advising, or research for Amgen, which markets denosumab and has received research funding from Novartis, which markets pamidronate and zoledronic acid. Dr. Von Roenn, co-chair of the guidelines panel, declared having no conflicts of interest. Two other panelists have been consultants, advisors, or recipients of honoraria from Roche or Abraxis BioScience.

Meeting the targets in consensus recommendations on inpatient glycemic control requires different protocols for different kinds of patients.

For hospitalized patients who are not critically ill, a protocol employing scheduled subcutaneous insulin therapy with basal, nutritional, and correctional components is effective, Dr. Mary T. Korytkowski said at a meeting sponsored by the American Diabetes Association.

For critically ill patients, intravenous insulin infusion protocols are better for achieving and maintaining glycemic control, she said. Many hospitals further subdivide the protocol for critically ill patients to have different glycemic targets for surgical and nonsurgical ICU patients, added Dr. Korytkowski, professor of medicine at the University of Pittsburgh's Center for Diabetes and Endocrinology.

Meeting the targets in consensus recommendations on inpatient glycemic control requires different protocols for different kinds of patients.

For hospitalized patients who are not critically ill, a protocol employing scheduled subcutaneous insulin therapy with basal, nutritional, and correctional components is effective, Dr. Mary T. Korytkowski said at a meeting sponsored by the American Diabetes Association.

For critically ill patients, intravenous insulin infusion protocols are better for achieving and maintaining glycemic control, she said. Many hospitals further subdivide the protocol for critically ill patients to have different glycemic targets for surgical and nonsurgical ICU patients, added Dr. Korytkowski, professor of medicine at the University of Pittsburgh's Center for Diabetes and Endocrinology.

Meeting the targets in consensus recommendations on inpatient glycemic control requires different protocols for different kinds of patients.

For hospitalized patients who are not critically ill, a protocol employing scheduled subcutaneous insulin therapy with basal, nutritional, and correctional components is effective, Dr. Mary T. Korytkowski said at a meeting sponsored by the American Diabetes Association.

For critically ill patients, intravenous insulin infusion protocols are better for achieving and maintaining glycemic control, she said. Many hospitals further subdivide the protocol for critically ill patients to have different glycemic targets for surgical and nonsurgical ICU patients, added Dr. Korytkowski, professor of medicine at the University of Pittsburgh's Center for Diabetes and Endocrinology.

The combination of type 2 diabetes and depression doubled the overall risk of death and nearly tripled the likelihood of dying of cardiovascular disease within 6 years, an analysis of data on 78,282 women found.

Previous studies have shown an association between depression or diabetes and increased risk of death from any cause or from cardiovascular disease, but the combined effects of these diseases on mortality have not been well studied, especially in women. Earlier studies also tended to be smaller and to have shorter follow-up.

An Pan, Ph.D., of the Harvard School of Public Health, Boston, and his associates analyzed data on participants in the prospective Nurses’ Health Study who were 54-79 years of age in 2000 and who were followed until 2006. There were 979 deaths from cardiovascular disease and 4,654 deaths from any cause during that time.

Compared with the 80% of women who developed neither diabetes nor depression, the age-adjusted relative risk of death was 1.71 in the 5% of women with diabetes alone, 1.76 in the 14% of women with depression alone, and 3.11 in the 1% of women with both diseases. The relative risk of death from cardiovascular disease was 1.67 in women with depression alone, 1.37 in women with depression alone, and 2.72 in those with both diabetes and depression. The results were released online on Jan. 3 and will appear in January issue of Archives of General Psychiatry (2011;68:42-50).

The increased risks with either diabetes or depression were statistically significant, and the higher risks with both diseases were significant compared with either disease alone, even after adjustment for the effects of age, family history of diabetes and cancer, history of myocardial infarction, current marital status, ethnicity, body mass index, alcohol consumption, smoking status, current multivitamin use, estrogen hormone use, current aspirin use, and major comorbidities including hypertension, hypercholesterolemia, heart disease, stroke, and cancer.

The highest risks were seen in women with depression combined with more severe diabetes, indicated by a longer duration of diabetes or treatment with oral medication or insulin. Death from cardiovascular disease was three times more likely in depressed women who had had diabetes for more than 10 years, and four times more likely in depressed women who received insulin therapy for diabetes, compared with women who had neither depression nor diabetes.

The greater likelihood of death or of death from cardiovascular disease in women with both diabetes and depression deserves greater attention, especially considering that 20%-25% of people with diabetes are depressed, the investigators suggested. An estimated 24 million U.S. adults have diabetes and 15 million U.S. adults are depressed. Adults with diabetes are twice as likely to be depressed, compared with those without diabetes.

In general, physicians don’t do a great job of recognizing major depression, and the United States can claim a relatively high prevalence of untreated mental disorders, they added. Better strategies may be needed to provide adequate psychological management and support for people with diabetes. In addition, the co-existence of depression and diabetes should identify women who are at particularly high risk, the investigators concluded.

The underlying mechanisms of the association between increased mortality and depression in women with diabetes are unknown.

The Nurses’ Health Study, ongoing since 1976, has followed a large cohort of female nurses every 2 years with mailed questionnaires (and phone calls if necessary), and had better than a 94% follow-up rate through 2006. Deaths were identified by the next of kin, postal authorities, or National Death Index. The investigators obtained the medical records and death certificates of those who died to determine the cause of death.

The current analysis excluded participants with a history of gestational diabetes, type 1 diabetes, secondary diabetes, or missing data regarding depression or diabetes.

The investigators reported having no conflicts of interest. The study was funded by the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, and the Fonds de Recherche en Santé du Québec.

The combination of type 2 diabetes and depression doubled the overall risk of death and nearly tripled the likelihood of dying of cardiovascular disease within 6 years, an analysis of data on 78,282 women found.

Previous studies have shown an association between depression or diabetes and increased risk of death from any cause or from cardiovascular disease, but the combined effects of these diseases on mortality have not been well studied, especially in women. Earlier studies also tended to be smaller and to have shorter follow-up.

An Pan, Ph.D., of the Harvard School of Public Health, Boston, and his associates analyzed data on participants in the prospective Nurses’ Health Study who were 54-79 years of age in 2000 and who were followed until 2006. There were 979 deaths from cardiovascular disease and 4,654 deaths from any cause during that time.

Compared with the 80% of women who developed neither diabetes nor depression, the age-adjusted relative risk of death was 1.71 in the 5% of women with diabetes alone, 1.76 in the 14% of women with depression alone, and 3.11 in the 1% of women with both diseases. The relative risk of death from cardiovascular disease was 1.67 in women with depression alone, 1.37 in women with depression alone, and 2.72 in those with both diabetes and depression. The results were released online on Jan. 3 and will appear in January issue of Archives of General Psychiatry (2011;68:42-50).

The increased risks with either diabetes or depression were statistically significant, and the higher risks with both diseases were significant compared with either disease alone, even after adjustment for the effects of age, family history of diabetes and cancer, history of myocardial infarction, current marital status, ethnicity, body mass index, alcohol consumption, smoking status, current multivitamin use, estrogen hormone use, current aspirin use, and major comorbidities including hypertension, hypercholesterolemia, heart disease, stroke, and cancer.

The highest risks were seen in women with depression combined with more severe diabetes, indicated by a longer duration of diabetes or treatment with oral medication or insulin. Death from cardiovascular disease was three times more likely in depressed women who had had diabetes for more than 10 years, and four times more likely in depressed women who received insulin therapy for diabetes, compared with women who had neither depression nor diabetes.

The greater likelihood of death or of death from cardiovascular disease in women with both diabetes and depression deserves greater attention, especially considering that 20%-25% of people with diabetes are depressed, the investigators suggested. An estimated 24 million U.S. adults have diabetes and 15 million U.S. adults are depressed. Adults with diabetes are twice as likely to be depressed, compared with those without diabetes.

In general, physicians don’t do a great job of recognizing major depression, and the United States can claim a relatively high prevalence of untreated mental disorders, they added. Better strategies may be needed to provide adequate psychological management and support for people with diabetes. In addition, the co-existence of depression and diabetes should identify women who are at particularly high risk, the investigators concluded.

The underlying mechanisms of the association between increased mortality and depression in women with diabetes are unknown.

The Nurses’ Health Study, ongoing since 1976, has followed a large cohort of female nurses every 2 years with mailed questionnaires (and phone calls if necessary), and had better than a 94% follow-up rate through 2006. Deaths were identified by the next of kin, postal authorities, or National Death Index. The investigators obtained the medical records and death certificates of those who died to determine the cause of death.

The current analysis excluded participants with a history of gestational diabetes, type 1 diabetes, secondary diabetes, or missing data regarding depression or diabetes.

The investigators reported having no conflicts of interest. The study was funded by the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, and the Fonds de Recherche en Santé du Québec.

The combination of type 2 diabetes and depression doubled the overall risk of death and nearly tripled the likelihood of dying of cardiovascular disease within 6 years, an analysis of data on 78,282 women found.

Previous studies have shown an association between depression or diabetes and increased risk of death from any cause or from cardiovascular disease, but the combined effects of these diseases on mortality have not been well studied, especially in women. Earlier studies also tended to be smaller and to have shorter follow-up.

An Pan, Ph.D., of the Harvard School of Public Health, Boston, and his associates analyzed data on participants in the prospective Nurses’ Health Study who were 54-79 years of age in 2000 and who were followed until 2006. There were 979 deaths from cardiovascular disease and 4,654 deaths from any cause during that time.

Compared with the 80% of women who developed neither diabetes nor depression, the age-adjusted relative risk of death was 1.71 in the 5% of women with diabetes alone, 1.76 in the 14% of women with depression alone, and 3.11 in the 1% of women with both diseases. The relative risk of death from cardiovascular disease was 1.67 in women with depression alone, 1.37 in women with depression alone, and 2.72 in those with both diabetes and depression. The results were released online on Jan. 3 and will appear in January issue of Archives of General Psychiatry (2011;68:42-50).

The increased risks with either diabetes or depression were statistically significant, and the higher risks with both diseases were significant compared with either disease alone, even after adjustment for the effects of age, family history of diabetes and cancer, history of myocardial infarction, current marital status, ethnicity, body mass index, alcohol consumption, smoking status, current multivitamin use, estrogen hormone use, current aspirin use, and major comorbidities including hypertension, hypercholesterolemia, heart disease, stroke, and cancer.

The highest risks were seen in women with depression combined with more severe diabetes, indicated by a longer duration of diabetes or treatment with oral medication or insulin. Death from cardiovascular disease was three times more likely in depressed women who had had diabetes for more than 10 years, and four times more likely in depressed women who received insulin therapy for diabetes, compared with women who had neither depression nor diabetes.

The greater likelihood of death or of death from cardiovascular disease in women with both diabetes and depression deserves greater attention, especially considering that 20%-25% of people with diabetes are depressed, the investigators suggested. An estimated 24 million U.S. adults have diabetes and 15 million U.S. adults are depressed. Adults with diabetes are twice as likely to be depressed, compared with those without diabetes.

In general, physicians don’t do a great job of recognizing major depression, and the United States can claim a relatively high prevalence of untreated mental disorders, they added. Better strategies may be needed to provide adequate psychological management and support for people with diabetes. In addition, the co-existence of depression and diabetes should identify women who are at particularly high risk, the investigators concluded.

The underlying mechanisms of the association between increased mortality and depression in women with diabetes are unknown.

The Nurses’ Health Study, ongoing since 1976, has followed a large cohort of female nurses every 2 years with mailed questionnaires (and phone calls if necessary), and had better than a 94% follow-up rate through 2006. Deaths were identified by the next of kin, postal authorities, or National Death Index. The investigators obtained the medical records and death certificates of those who died to determine the cause of death.

The current analysis excluded participants with a history of gestational diabetes, type 1 diabetes, secondary diabetes, or missing data regarding depression or diabetes.

The investigators reported having no conflicts of interest. The study was funded by the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, and the Fonds de Recherche en Santé du Québec.

LOS ANGELES – Neurologists may have moved one step closer to identifying patients with stroke of unclear onset who might benefit from treatment, a prospective multicenter study suggests.

About 25% of ischemic strokes occur in people who don’t know, or are unable to communicate, when their stroke began. Guidelines call for IV thrombolysis to be given within 4.5 hours of symptom onset, the effective treatment window for reducing disability, and patients with unclear-onset stroke traditionally have been excluded from thrombolytic therapy.

The study of 430 patients with unclear-onset stroke showed that basing treatment on MRI evaluation is feasible, with safety and efficacy similar to what was seen in pivotal trials of thrombolytic therapy, Dr. Dong-Wha Kang said Feb. 10 at the International Stroke Conference. The current study lacked a control group of comparable patients who did not receive therapy, however, making the true effect of treatment in these patients difficult to assess.

The 10 patients who were treated at two centers with little previous experience in thrombolysis for unclear-onset stroke were 11 times more likely to have poor clinical outcomes than were the patients treated at four centers where interventionists already had been selecting patients empirically for treatment of unclear-onset stroke. This difference in clinical outcomes "might be related to the expertise or the skill of the interventionists," Dr. Kang said at the meeting, sponsored by the American Heart Association.

He and his associates screened consecutive patients with unclear-onset stroke who presented at six university hospitals in South Korea within 6 hours of symptom detection. They used multimodal MRI to look for sizable areas with live brain tissue despite lack of blood flow, and to exclude patients from therapy who were at higher risk of serious bleeding from thrombolytic therapy or who were past the time of tissue death.

Patients qualified for reperfusion therapy if MRI findings showed the presence of greater than a 20% perfusion-diffusion mismatch, absence of extensive early infarct (with "extensive" defined as infarct in more than a third of middle cerebral artery territory) on diffusion-weighted imaging, and absence of well-developed parenchymal hyperintensity on fluid-attenuated inversion-recovery (FLAIR) imaging or T2 images.

A total of 83 patients (19% of the cohort) received reperfusion therapy, which included IV tissue plasminogen activator (tPA) with or without intra-arterial urokinase within 3 hours, or intra-arterial urokinase within 6 hours from symptom detection. (Urokinase is approved in Korea but not in the United States.) The study also allowed mechanical clot disruption or stenting. In all, 57 patients were treated using an endovascular approach (69%), 9 patients were treated with IV tPA only (11%), and both approaches were used in 17 patients (21%). (Percentages were rounded.)

In the 83 patients who underwent reperfusion therapy, 37 had a good clinical outcome (45%), defined as a score of 0-2 on the modified Rankin scale at 3-month follow-up, reported Dr. Kang of the University of Ulsan, Seoul, South Korea, and 24 patients (29%) had excellent clinical outcomes.

Eight patients developed symptomatic intracranial hemorrhage, five with neurological decline (6%) and three with at least a four-point increase in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours after treatment.

Poor clinical outcomes were nine times more likely in women than in men and 11% more likely in patients with higher baseline NIHSS scores. The treated patients had a mean age of 67 years and a median baseline NIHSS score of 14.

The investigators compared the clinical results with separate data from 156 similar patients whose stroke onset times were known. The percentage of patients who had good outcomes did not differ significantly between those groups, he said.

Dr. Kang received an award for the best paper in emergency medicine at the meeting.

The findings should be applicable to non-Korean populations, with variable patient outcomes depending on the availability of MRI and of interventionists to administer thrombolytic drugs, Dr. Kang said. Nine patients received treatment in violation of eligibility protocols, a review found. There were no significant differences in outcomes in patients treated per protocol or against protocol, but these are small groups of patients, he cautioned.

Dr. Kang and his associates next plan to compare their findings with data from stroke registries on comparable patients with unclear-onset stroke who were not treated.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Neurologists may have moved one step closer to identifying patients with stroke of unclear onset who might benefit from treatment, a prospective multicenter study suggests.

About 25% of ischemic strokes occur in people who don’t know, or are unable to communicate, when their stroke began. Guidelines call for IV thrombolysis to be given within 4.5 hours of symptom onset, the effective treatment window for reducing disability, and patients with unclear-onset stroke traditionally have been excluded from thrombolytic therapy.

The study of 430 patients with unclear-onset stroke showed that basing treatment on MRI evaluation is feasible, with safety and efficacy similar to what was seen in pivotal trials of thrombolytic therapy, Dr. Dong-Wha Kang said Feb. 10 at the International Stroke Conference. The current study lacked a control group of comparable patients who did not receive therapy, however, making the true effect of treatment in these patients difficult to assess.

The 10 patients who were treated at two centers with little previous experience in thrombolysis for unclear-onset stroke were 11 times more likely to have poor clinical outcomes than were the patients treated at four centers where interventionists already had been selecting patients empirically for treatment of unclear-onset stroke. This difference in clinical outcomes "might be related to the expertise or the skill of the interventionists," Dr. Kang said at the meeting, sponsored by the American Heart Association.

He and his associates screened consecutive patients with unclear-onset stroke who presented at six university hospitals in South Korea within 6 hours of symptom detection. They used multimodal MRI to look for sizable areas with live brain tissue despite lack of blood flow, and to exclude patients from therapy who were at higher risk of serious bleeding from thrombolytic therapy or who were past the time of tissue death.

Patients qualified for reperfusion therapy if MRI findings showed the presence of greater than a 20% perfusion-diffusion mismatch, absence of extensive early infarct (with "extensive" defined as infarct in more than a third of middle cerebral artery territory) on diffusion-weighted imaging, and absence of well-developed parenchymal hyperintensity on fluid-attenuated inversion-recovery (FLAIR) imaging or T2 images.

A total of 83 patients (19% of the cohort) received reperfusion therapy, which included IV tissue plasminogen activator (tPA) with or without intra-arterial urokinase within 3 hours, or intra-arterial urokinase within 6 hours from symptom detection. (Urokinase is approved in Korea but not in the United States.) The study also allowed mechanical clot disruption or stenting. In all, 57 patients were treated using an endovascular approach (69%), 9 patients were treated with IV tPA only (11%), and both approaches were used in 17 patients (21%). (Percentages were rounded.)

In the 83 patients who underwent reperfusion therapy, 37 had a good clinical outcome (45%), defined as a score of 0-2 on the modified Rankin scale at 3-month follow-up, reported Dr. Kang of the University of Ulsan, Seoul, South Korea, and 24 patients (29%) had excellent clinical outcomes.

Eight patients developed symptomatic intracranial hemorrhage, five with neurological decline (6%) and three with at least a four-point increase in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours after treatment.

Poor clinical outcomes were nine times more likely in women than in men and 11% more likely in patients with higher baseline NIHSS scores. The treated patients had a mean age of 67 years and a median baseline NIHSS score of 14.

The investigators compared the clinical results with separate data from 156 similar patients whose stroke onset times were known. The percentage of patients who had good outcomes did not differ significantly between those groups, he said.

Dr. Kang received an award for the best paper in emergency medicine at the meeting.

The findings should be applicable to non-Korean populations, with variable patient outcomes depending on the availability of MRI and of interventionists to administer thrombolytic drugs, Dr. Kang said. Nine patients received treatment in violation of eligibility protocols, a review found. There were no significant differences in outcomes in patients treated per protocol or against protocol, but these are small groups of patients, he cautioned.

Dr. Kang and his associates next plan to compare their findings with data from stroke registries on comparable patients with unclear-onset stroke who were not treated.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Neurologists may have moved one step closer to identifying patients with stroke of unclear onset who might benefit from treatment, a prospective multicenter study suggests.

About 25% of ischemic strokes occur in people who don’t know, or are unable to communicate, when their stroke began. Guidelines call for IV thrombolysis to be given within 4.5 hours of symptom onset, the effective treatment window for reducing disability, and patients with unclear-onset stroke traditionally have been excluded from thrombolytic therapy.

The study of 430 patients with unclear-onset stroke showed that basing treatment on MRI evaluation is feasible, with safety and efficacy similar to what was seen in pivotal trials of thrombolytic therapy, Dr. Dong-Wha Kang said Feb. 10 at the International Stroke Conference. The current study lacked a control group of comparable patients who did not receive therapy, however, making the true effect of treatment in these patients difficult to assess.

The 10 patients who were treated at two centers with little previous experience in thrombolysis for unclear-onset stroke were 11 times more likely to have poor clinical outcomes than were the patients treated at four centers where interventionists already had been selecting patients empirically for treatment of unclear-onset stroke. This difference in clinical outcomes "might be related to the expertise or the skill of the interventionists," Dr. Kang said at the meeting, sponsored by the American Heart Association.

He and his associates screened consecutive patients with unclear-onset stroke who presented at six university hospitals in South Korea within 6 hours of symptom detection. They used multimodal MRI to look for sizable areas with live brain tissue despite lack of blood flow, and to exclude patients from therapy who were at higher risk of serious bleeding from thrombolytic therapy or who were past the time of tissue death.

Patients qualified for reperfusion therapy if MRI findings showed the presence of greater than a 20% perfusion-diffusion mismatch, absence of extensive early infarct (with "extensive" defined as infarct in more than a third of middle cerebral artery territory) on diffusion-weighted imaging, and absence of well-developed parenchymal hyperintensity on fluid-attenuated inversion-recovery (FLAIR) imaging or T2 images.

A total of 83 patients (19% of the cohort) received reperfusion therapy, which included IV tissue plasminogen activator (tPA) with or without intra-arterial urokinase within 3 hours, or intra-arterial urokinase within 6 hours from symptom detection. (Urokinase is approved in Korea but not in the United States.) The study also allowed mechanical clot disruption or stenting. In all, 57 patients were treated using an endovascular approach (69%), 9 patients were treated with IV tPA only (11%), and both approaches were used in 17 patients (21%). (Percentages were rounded.)

In the 83 patients who underwent reperfusion therapy, 37 had a good clinical outcome (45%), defined as a score of 0-2 on the modified Rankin scale at 3-month follow-up, reported Dr. Kang of the University of Ulsan, Seoul, South Korea, and 24 patients (29%) had excellent clinical outcomes.

Eight patients developed symptomatic intracranial hemorrhage, five with neurological decline (6%) and three with at least a four-point increase in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours after treatment.

Poor clinical outcomes were nine times more likely in women than in men and 11% more likely in patients with higher baseline NIHSS scores. The treated patients had a mean age of 67 years and a median baseline NIHSS score of 14.

The investigators compared the clinical results with separate data from 156 similar patients whose stroke onset times were known. The percentage of patients who had good outcomes did not differ significantly between those groups, he said.

Dr. Kang received an award for the best paper in emergency medicine at the meeting.

The findings should be applicable to non-Korean populations, with variable patient outcomes depending on the availability of MRI and of interventionists to administer thrombolytic drugs, Dr. Kang said. Nine patients received treatment in violation of eligibility protocols, a review found. There were no significant differences in outcomes in patients treated per protocol or against protocol, but these are small groups of patients, he cautioned.

Dr. Kang and his associates next plan to compare their findings with data from stroke registries on comparable patients with unclear-onset stroke who were not treated.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Hospitalizations of young people for acute ischemic stroke rose significantly over a 14-year period, with a roughly 50% increase in prevalence in the age range of 5-44 years.

However, the prevalence of stroke hospitalizations decreased significantly in older people, an analysis of data by the U.S. Centers for Disease Control and Prevention (CDC) found. Researchers studied data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project on hospitalizations (not patients) for acute ischemic stroke from 1994 to 2007, based on hospital coding.

The proportion of hospitalizations due to acute ischemic stroke increased in four of six age categories analyzed and decreased in two age groups, Dr. Mary G. George said in a press conference at the International Stroke Conference. Males aged 15-34 years tallied the biggest jump, a 53% increase, from 9.8 acute ischemic strokes per 10,000 hospitalizations in 1994-1995 to 14.8/10,000 in 2006-2007. Among females aged 15-34 years, the prevalence of ischemic stroke increased by 17%, from 3.6/10,000 to 4.2/10,000 hospitalizations.

The prevalence of acute ischemic stroke hospitalizations increased by 47% in men aged 35-44 years, from 36/10,000 hospitalizations to 52.9/10,000. The prevalence in women aged 35-44 years increased by 36%, from 21.9/10,000 to 30/10,000 hospitalizations, reported Dr. George, medical officer in the division of heart disease and stroke prevention at the CDC, Atlanta.

"Very modest" increases were seen for males and females aged 5-14 years, she said at the meeting, sponsored by the American Heart Association. The prevalence of acute ischemic stroke increased in males by 36% (from 2.8 to 3.8/10,000 hospitalizations) and by 31% in females (from 3.6 to 4.7/10,000 hospitalizations).

The study raises the unanswered question of the causes behind these increased rates of hospitalization for ischemic stroke. Risk factors for stroke became more prevalent in the time period studied because of the national obesity epidemic. It’s also possible that physicians are better at diagnosing stroke in young adults than they were before. In addition, trends in hospital billing, coding, or admitting practices may have played a role.

"We cannot link anything in particular to the trend in younger patients, but I believe the role of obesity and hypertension will prompt a big discussion. Unfortunately, right now we can’t speculate on the causes," Xin Ton, the lead investigator in the study and a health statistician at the CDC, said in a prepared statement released by the American Heart Association.

Dr. George said more research is needed into the causes behind the increased hospitalization rates for stroke, especially in young adults. "One of the things to keep in mind with this study is that we are not able to separate out trends over time in improved ability to make a diagnosis of stroke, perhaps increased referrals over this time to stroke neurologists, who might have a heightened awareness to look for stroke," she said. "Whether it is associated with increasing trends in traditional risk factors for stroke is unknown at this time," but "we clearly need to study" this possibility.

The prevalence of hospitalizations for ischemic stroke fell in females aged 0-4 years, from 0.78 to 0.38/10,000 hospitalizations, a "very modest" decrease of 51%, Dr. George said. For people older than 44 years, hospitalizations for ischemic stroke decreased by 25% for men and by 29% for women.

Among people aged 45-64 years old, rates of ischemic stroke declined from 195 to 172/10,000 hospitalizations for men and from 145 to 126/10,000 for women. Among people aged 65 or older, rates declined from 404 to 303/10,000 for men and from 379 to 274/10,000 for women.

The changes in prevalence of hospitalization for acute ischemic stroke were significant in all age groups and for both sexes except in males aged 0-4 years, who had a nonsignificant decrease from 0.6 to 0.4/10,000 hospitalizations.

Because of the methods used to identify stroke hospitalizations, "we’re fairly certain that we did not pick up all strokes in pregnancy," Dr. George added, which could affect the prevalence rates of ischemic stroke hospitalizations in the age groups containing women in their childbearing years. Separate research should examine stroke rates in pregnancy, she suggested.

The study was inspired by previous studies that suggested there may be trends toward increasing stroke in young adults, and in young women in particular, Dr. George said. The data sample represents about 20% of hospitals in an increasing number of states over time.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Hospitalizations of young people for acute ischemic stroke rose significantly over a 14-year period, with a roughly 50% increase in prevalence in the age range of 5-44 years.

However, the prevalence of stroke hospitalizations decreased significantly in older people, an analysis of data by the U.S. Centers for Disease Control and Prevention (CDC) found. Researchers studied data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project on hospitalizations (not patients) for acute ischemic stroke from 1994 to 2007, based on hospital coding.

The proportion of hospitalizations due to acute ischemic stroke increased in four of six age categories analyzed and decreased in two age groups, Dr. Mary G. George said in a press conference at the International Stroke Conference. Males aged 15-34 years tallied the biggest jump, a 53% increase, from 9.8 acute ischemic strokes per 10,000 hospitalizations in 1994-1995 to 14.8/10,000 in 2006-2007. Among females aged 15-34 years, the prevalence of ischemic stroke increased by 17%, from 3.6/10,000 to 4.2/10,000 hospitalizations.

The prevalence of acute ischemic stroke hospitalizations increased by 47% in men aged 35-44 years, from 36/10,000 hospitalizations to 52.9/10,000. The prevalence in women aged 35-44 years increased by 36%, from 21.9/10,000 to 30/10,000 hospitalizations, reported Dr. George, medical officer in the division of heart disease and stroke prevention at the CDC, Atlanta.

"Very modest" increases were seen for males and females aged 5-14 years, she said at the meeting, sponsored by the American Heart Association. The prevalence of acute ischemic stroke increased in males by 36% (from 2.8 to 3.8/10,000 hospitalizations) and by 31% in females (from 3.6 to 4.7/10,000 hospitalizations).

The study raises the unanswered question of the causes behind these increased rates of hospitalization for ischemic stroke. Risk factors for stroke became more prevalent in the time period studied because of the national obesity epidemic. It’s also possible that physicians are better at diagnosing stroke in young adults than they were before. In addition, trends in hospital billing, coding, or admitting practices may have played a role.

"We cannot link anything in particular to the trend in younger patients, but I believe the role of obesity and hypertension will prompt a big discussion. Unfortunately, right now we can’t speculate on the causes," Xin Ton, the lead investigator in the study and a health statistician at the CDC, said in a prepared statement released by the American Heart Association.

Dr. George said more research is needed into the causes behind the increased hospitalization rates for stroke, especially in young adults. "One of the things to keep in mind with this study is that we are not able to separate out trends over time in improved ability to make a diagnosis of stroke, perhaps increased referrals over this time to stroke neurologists, who might have a heightened awareness to look for stroke," she said. "Whether it is associated with increasing trends in traditional risk factors for stroke is unknown at this time," but "we clearly need to study" this possibility.

The prevalence of hospitalizations for ischemic stroke fell in females aged 0-4 years, from 0.78 to 0.38/10,000 hospitalizations, a "very modest" decrease of 51%, Dr. George said. For people older than 44 years, hospitalizations for ischemic stroke decreased by 25% for men and by 29% for women.

Among people aged 45-64 years old, rates of ischemic stroke declined from 195 to 172/10,000 hospitalizations for men and from 145 to 126/10,000 for women. Among people aged 65 or older, rates declined from 404 to 303/10,000 for men and from 379 to 274/10,000 for women.

The changes in prevalence of hospitalization for acute ischemic stroke were significant in all age groups and for both sexes except in males aged 0-4 years, who had a nonsignificant decrease from 0.6 to 0.4/10,000 hospitalizations.

Because of the methods used to identify stroke hospitalizations, "we’re fairly certain that we did not pick up all strokes in pregnancy," Dr. George added, which could affect the prevalence rates of ischemic stroke hospitalizations in the age groups containing women in their childbearing years. Separate research should examine stroke rates in pregnancy, she suggested.

The study was inspired by previous studies that suggested there may be trends toward increasing stroke in young adults, and in young women in particular, Dr. George said. The data sample represents about 20% of hospitals in an increasing number of states over time.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Hospitalizations of young people for acute ischemic stroke rose significantly over a 14-year period, with a roughly 50% increase in prevalence in the age range of 5-44 years.

However, the prevalence of stroke hospitalizations decreased significantly in older people, an analysis of data by the U.S. Centers for Disease Control and Prevention (CDC) found. Researchers studied data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project on hospitalizations (not patients) for acute ischemic stroke from 1994 to 2007, based on hospital coding.

The proportion of hospitalizations due to acute ischemic stroke increased in four of six age categories analyzed and decreased in two age groups, Dr. Mary G. George said in a press conference at the International Stroke Conference. Males aged 15-34 years tallied the biggest jump, a 53% increase, from 9.8 acute ischemic strokes per 10,000 hospitalizations in 1994-1995 to 14.8/10,000 in 2006-2007. Among females aged 15-34 years, the prevalence of ischemic stroke increased by 17%, from 3.6/10,000 to 4.2/10,000 hospitalizations.

The prevalence of acute ischemic stroke hospitalizations increased by 47% in men aged 35-44 years, from 36/10,000 hospitalizations to 52.9/10,000. The prevalence in women aged 35-44 years increased by 36%, from 21.9/10,000 to 30/10,000 hospitalizations, reported Dr. George, medical officer in the division of heart disease and stroke prevention at the CDC, Atlanta.

"Very modest" increases were seen for males and females aged 5-14 years, she said at the meeting, sponsored by the American Heart Association. The prevalence of acute ischemic stroke increased in males by 36% (from 2.8 to 3.8/10,000 hospitalizations) and by 31% in females (from 3.6 to 4.7/10,000 hospitalizations).

The study raises the unanswered question of the causes behind these increased rates of hospitalization for ischemic stroke. Risk factors for stroke became more prevalent in the time period studied because of the national obesity epidemic. It’s also possible that physicians are better at diagnosing stroke in young adults than they were before. In addition, trends in hospital billing, coding, or admitting practices may have played a role.

"We cannot link anything in particular to the trend in younger patients, but I believe the role of obesity and hypertension will prompt a big discussion. Unfortunately, right now we can’t speculate on the causes," Xin Ton, the lead investigator in the study and a health statistician at the CDC, said in a prepared statement released by the American Heart Association.

Dr. George said more research is needed into the causes behind the increased hospitalization rates for stroke, especially in young adults. "One of the things to keep in mind with this study is that we are not able to separate out trends over time in improved ability to make a diagnosis of stroke, perhaps increased referrals over this time to stroke neurologists, who might have a heightened awareness to look for stroke," she said. "Whether it is associated with increasing trends in traditional risk factors for stroke is unknown at this time," but "we clearly need to study" this possibility.

The prevalence of hospitalizations for ischemic stroke fell in females aged 0-4 years, from 0.78 to 0.38/10,000 hospitalizations, a "very modest" decrease of 51%, Dr. George said. For people older than 44 years, hospitalizations for ischemic stroke decreased by 25% for men and by 29% for women.

Among people aged 45-64 years old, rates of ischemic stroke declined from 195 to 172/10,000 hospitalizations for men and from 145 to 126/10,000 for women. Among people aged 65 or older, rates declined from 404 to 303/10,000 for men and from 379 to 274/10,000 for women.

The changes in prevalence of hospitalization for acute ischemic stroke were significant in all age groups and for both sexes except in males aged 0-4 years, who had a nonsignificant decrease from 0.6 to 0.4/10,000 hospitalizations.

Because of the methods used to identify stroke hospitalizations, "we’re fairly certain that we did not pick up all strokes in pregnancy," Dr. George added, which could affect the prevalence rates of ischemic stroke hospitalizations in the age groups containing women in their childbearing years. Separate research should examine stroke rates in pregnancy, she suggested.

The study was inspired by previous studies that suggested there may be trends toward increasing stroke in young adults, and in young women in particular, Dr. George said. The data sample represents about 20% of hospitals in an increasing number of states over time.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Hospitalizations of young people for acute ischemic stroke rose significantly over a 14-year period, with a roughly 50% increase in prevalence in the age range of 5-44 years.

However, the prevalence of stroke hospitalizations decreased significantly in older people, an analysis of data by the U.S. Centers for Disease Control and Prevention (CDC) found. Researchers studied data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project on hospitalizations (not patients) for acute ischemic stroke from 1994 to 2007, based on hospital coding.

The proportion of hospitalizations due to acute ischemic stroke increased in four of six age categories analyzed and decreased in two age groups, Dr. Mary G. George said in a press conference at the International Stroke Conference. Males aged 15-34 years tallied the biggest jump, a 53% increase, from 9.8 acute ischemic strokes per 10,000 hospitalizations in 1994-1995 to 14.8/10,000 in 2006-2007. Among females aged 15-34 years, the prevalence of ischemic stroke increased by 17%, from 3.6/10,000 to 4.2/10,000 hospitalizations.

The prevalence of acute ischemic stroke hospitalizations increased by 47% in men aged 35-44 years, from 36/10,000 hospitalizations to 52.9/10,000. The prevalence in women aged 35-44 years increased by 36%, from 21.9/10,000 to 30/10,000 hospitalizations, reported Dr. George, medical officer in the division of heart disease and stroke prevention at the CDC, Atlanta.

"Very modest" increases were seen for males and females aged 5-14 years, she said at the meeting, sponsored by the American Heart Association. The prevalence of acute ischemic stroke increased in males by 36% (from 2.8 to 3.8/10,000 hospitalizations) and by 31% in females (from 3.6 to 4.7/10,000 hospitalizations).

The study raises the unanswered question of the causes behind these increased rates of hospitalization for ischemic stroke. Risk factors for stroke became more prevalent in the time period studied because of the national obesity epidemic. It’s also possible that physicians are better at diagnosing stroke in young adults than they were before. In addition, trends in hospital billing, coding, or admitting practices may have played a role.

"We cannot link anything in particular to the trend in younger patients, but I believe the role of obesity and hypertension will prompt a big discussion. Unfortunately, right now we can’t speculate on the causes," Xin Ton, the lead investigator in the study and a health statistician at the CDC, said in a prepared statement released by the American Heart Association.

Dr. George said more research is needed into the causes behind the increased hospitalization rates for stroke, especially in young adults. "One of the things to keep in mind with this study is that we are not able to separate out trends over time in improved ability to make a diagnosis of stroke, perhaps increased referrals over this time to stroke neurologists, who might have a heightened awareness to look for stroke," she said. "Whether it is associated with increasing trends in traditional risk factors for stroke is unknown at this time," but "we clearly need to study" this possibility.

The prevalence of hospitalizations for ischemic stroke fell in females aged 0-4 years, from 0.78 to 0.38/10,000 hospitalizations, a "very modest" decrease of 51%, Dr. George said. For people older than 44 years, hospitalizations for ischemic stroke decreased by 25% for men and by 29% for women.

Among people aged 45-64 years old, rates of ischemic stroke declined from 195 to 172/10,000 hospitalizations for men and from 145 to 126/10,000 for women. Among people aged 65 or older, rates declined from 404 to 303/10,000 for men and from 379 to 274/10,000 for women.

The changes in prevalence of hospitalization for acute ischemic stroke were significant in all age groups and for both sexes except in males aged 0-4 years, who had a nonsignificant decrease from 0.6 to 0.4/10,000 hospitalizations.

Because of the methods used to identify stroke hospitalizations, "we’re fairly certain that we did not pick up all strokes in pregnancy," Dr. George added, which could affect the prevalence rates of ischemic stroke hospitalizations in the age groups containing women in their childbearing years. Separate research should examine stroke rates in pregnancy, she suggested.

The study was inspired by previous studies that suggested there may be trends toward increasing stroke in young adults, and in young women in particular, Dr. George said. The data sample represents about 20% of hospitals in an increasing number of states over time.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Hospitalizations of young people for acute ischemic stroke rose significantly over a 14-year period, with a roughly 50% increase in prevalence in the age range of 5-44 years.

However, the prevalence of stroke hospitalizations decreased significantly in older people, an analysis of data by the U.S. Centers for Disease Control and Prevention (CDC) found. Researchers studied data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project on hospitalizations (not patients) for acute ischemic stroke from 1994 to 2007, based on hospital coding.

The proportion of hospitalizations due to acute ischemic stroke increased in four of six age categories analyzed and decreased in two age groups, Dr. Mary G. George said in a press conference at the International Stroke Conference. Males aged 15-34 years tallied the biggest jump, a 53% increase, from 9.8 acute ischemic strokes per 10,000 hospitalizations in 1994-1995 to 14.8/10,000 in 2006-2007. Among females aged 15-34 years, the prevalence of ischemic stroke increased by 17%, from 3.6/10,000 to 4.2/10,000 hospitalizations.

The prevalence of acute ischemic stroke hospitalizations increased by 47% in men aged 35-44 years, from 36/10,000 hospitalizations to 52.9/10,000. The prevalence in women aged 35-44 years increased by 36%, from 21.9/10,000 to 30/10,000 hospitalizations, reported Dr. George, medical officer in the division of heart disease and stroke prevention at the CDC, Atlanta.

"Very modest" increases were seen for males and females aged 5-14 years, she said at the meeting, sponsored by the American Heart Association. The prevalence of acute ischemic stroke increased in males by 36% (from 2.8 to 3.8/10,000 hospitalizations) and by 31% in females (from 3.6 to 4.7/10,000 hospitalizations).

The study raises the unanswered question of the causes behind these increased rates of hospitalization for ischemic stroke. Risk factors for stroke became more prevalent in the time period studied because of the national obesity epidemic. It’s also possible that physicians are better at diagnosing stroke in young adults than they were before. In addition, trends in hospital billing, coding, or admitting practices may have played a role.

"We cannot link anything in particular to the trend in younger patients, but I believe the role of obesity and hypertension will prompt a big discussion. Unfortunately, right now we can’t speculate on the causes," Xin Ton, the lead investigator in the study and a health statistician at the CDC, said in a prepared statement released by the American Heart Association.

Dr. George said more research is needed into the causes behind the increased hospitalization rates for stroke, especially in young adults. "One of the things to keep in mind with this study is that we are not able to separate out trends over time in improved ability to make a diagnosis of stroke, perhaps increased referrals over this time to stroke neurologists, who might have a heightened awareness to look for stroke," she said. "Whether it is associated with increasing trends in traditional risk factors for stroke is unknown at this time," but "we clearly need to study" this possibility.

The prevalence of hospitalizations for ischemic stroke fell in females aged 0-4 years, from 0.78 to 0.38/10,000 hospitalizations, a "very modest" decrease of 51%, Dr. George said. For people older than 44 years, hospitalizations for ischemic stroke decreased by 25% for men and by 29% for women.

Among people aged 45-64 years old, rates of ischemic stroke declined from 195 to 172/10,000 hospitalizations for men and from 145 to 126/10,000 for women. Among people aged 65 or older, rates declined from 404 to 303/10,000 for men and from 379 to 274/10,000 for women.

The changes in prevalence of hospitalization for acute ischemic stroke were significant in all age groups and for both sexes except in males aged 0-4 years, who had a nonsignificant decrease from 0.6 to 0.4/10,000 hospitalizations.

Because of the methods used to identify stroke hospitalizations, "we’re fairly certain that we did not pick up all strokes in pregnancy," Dr. George added, which could affect the prevalence rates of ischemic stroke hospitalizations in the age groups containing women in their childbearing years. Separate research should examine stroke rates in pregnancy, she suggested.

The study was inspired by previous studies that suggested there may be trends toward increasing stroke in young adults, and in young women in particular, Dr. George said. The data sample represents about 20% of hospitals in an increasing number of states over time.

The investigators reported having no relevant conflicts of interest.

LOS ANGELES – Hospitalizations of young people for acute ischemic stroke rose significantly over a 14-year period, with a roughly 50% increase in prevalence in the age range of 5-44 years.

However, the prevalence of stroke hospitalizations decreased significantly in older people, an analysis of data by the U.S. Centers for Disease Control and Prevention (CDC) found. Researchers studied data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project on hospitalizations (not patients) for acute ischemic stroke from 1994 to 2007, based on hospital coding.

The proportion of hospitalizations due to acute ischemic stroke increased in four of six age categories analyzed and decreased in two age groups, Dr. Mary G. George said in a press conference at the International Stroke Conference. Males aged 15-34 years tallied the biggest jump, a 53% increase, from 9.8 acute ischemic strokes per 10,000 hospitalizations in 1994-1995 to 14.8/10,000 in 2006-2007. Among females aged 15-34 years, the prevalence of ischemic stroke increased by 17%, from 3.6/10,000 to 4.2/10,000 hospitalizations.

The prevalence of acute ischemic stroke hospitalizations increased by 47% in men aged 35-44 years, from 36/10,000 hospitalizations to 52.9/10,000. The prevalence in women aged 35-44 years increased by 36%, from 21.9/10,000 to 30/10,000 hospitalizations, reported Dr. George, medical officer in the division of heart disease and stroke prevention at the CDC, Atlanta.

"Very modest" increases were seen for males and females aged 5-14 years, she said at the meeting, sponsored by the American Heart Association. The prevalence of acute ischemic stroke increased in males by 36% (from 2.8 to 3.8/10,000 hospitalizations) and by 31% in females (from 3.6 to 4.7/10,000 hospitalizations).

The study raises the unanswered question of the causes behind these increased rates of hospitalization for ischemic stroke. Risk factors for stroke became more prevalent in the time period studied because of the national obesity epidemic. It’s also possible that physicians are better at diagnosing stroke in young adults than they were before. In addition, trends in hospital billing, coding, or admitting practices may have played a role.

"We cannot link anything in particular to the trend in younger patients, but I believe the role of obesity and hypertension will prompt a big discussion. Unfortunately, right now we can’t speculate on the causes," Xin Ton, the lead investigator in the study and a health statistician at the CDC, said in a prepared statement released by the American Heart Association.

Dr. George said more research is needed into the causes behind the increased hospitalization rates for stroke, especially in young adults. "One of the things to keep in mind with this study is that we are not able to separate out trends over time in improved ability to make a diagnosis of stroke, perhaps increased referrals over this time to stroke neurologists, who might have a heightened awareness to look for stroke," she said. "Whether it is associated with increasing trends in traditional risk factors for stroke is unknown at this time," but "we clearly need to study" this possibility.

The prevalence of hospitalizations for ischemic stroke fell in females aged 0-4 years, from 0.78 to 0.38/10,000 hospitalizations, a "very modest" decrease of 51%, Dr. George said. For people older than 44 years, hospitalizations for ischemic stroke decreased by 25% for men and by 29% for women.

Among people aged 45-64 years old, rates of ischemic stroke declined from 195 to 172/10,000 hospitalizations for men and from 145 to 126/10,000 for women. Among people aged 65 or older, rates declined from 404 to 303/10,000 for men and from 379 to 274/10,000 for women.

The changes in prevalence of hospitalization for acute ischemic stroke were significant in all age groups and for both sexes except in males aged 0-4 years, who had a nonsignificant decrease from 0.6 to 0.4/10,000 hospitalizations.

Because of the methods used to identify stroke hospitalizations, "we’re fairly certain that we did not pick up all strokes in pregnancy," Dr. George added, which could affect the prevalence rates of ischemic stroke hospitalizations in the age groups containing women in their childbearing years. Separate research should examine stroke rates in pregnancy, she suggested.

The study was inspired by previous studies that suggested there may be trends toward increasing stroke in young adults, and in young women in particular, Dr. George said. The data sample represents about 20% of hospitals in an increasing number of states over time.

The investigators reported having no relevant conflicts of interest.