M. Alexander Otto

Every patient should get an electrocardiogram prior to and 6 hours after the first dose of fingolimod, and hourly blood pressure and heart rate measurements in between, to assess for bradycardia, according to revised labeling released by the Food and Drug Administration on May 9.

Patients with prolonged QTc intervals during the observation period should be observed overnight with continuous ECG monitoring, labeling now states.

The revisions come after more than a dozen reports of sudden or unexplained deaths in the United States and Europe following the drug’s 2010 approval for relapsing forms of multiple sclerosis, and months-long talks between the FDA and Novartis, the maker of fingolimod (Gilenya). Previous labeling recommended baseline ECGs only "in those at higher risk of bradyarrhythmia."

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• 

     Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

--------------------------------------------------------------------------------------------------

Novartis noted in a press release that fingolimod has been used in more than 36,000 patients.

Labeling also now calls for overnight, continuous ECG monitoring in a medical facility for patients with preexisting heart conditions, cerebrovascular disease, recurrent syncope, or severe untreated sleep apnea; patients on beta-blockers or other drugs that slow heart rate or atrioventricular (AV) conduction; and patients with prolonged QTc intervals, whether due to drugs or medical conditions. ECG monitoring is also warranted, in some cases, for patients restarting the drug after a pause.

"Isolated delayed onset events, including transient asystole and unexplained death, have occurred within 24 hours of the first dose," the revised labeling notes, although the relationship with fingolimod is "uncertain."

The new label contraindicates the drug in patients who, in the last 6 months, have had a heart attack, unstable angina, stroke, transient ischemic attack, second- or third-degree AV block, decompensated heart failure requiring hospitalization, sick sinus syndrome with no pacemaker, baseline QTc interval of 500 ms or longer, and treatment with class Ia or class III antiarrhythmic drugs. Previous labeling had no contraindications.

Those and other changes come shortly after the annual meeting of the American Academy of Neurology, where Novartis released the results of its recent 2-year, double-blind, placebo-controlled, multicenter, phase III trial of fingolimod in 1,083 patients with relapsing-remitting multiple sclerosis.

At month 24, 0.5 mg of fingolimod once daily significantly reduced patients’ annualized relapse rates by 48% versus placebo. Fingolimod patients also had a statistically significant reduction in brain volume loss.

Those results are consistent with previous trials of the drug (N. Engl. J. Med. 2010;362:387-401; N. Engl. J. Med. 2006;355:1124-40). But in contrast to those studies, fingolimod did not show a statistically significant benefit over placebo on 2-year EDSS (Expanded Disability Status Scale) disability progression.

Overall, "there were probably not any new [safety] signals" in the recent trial, "but some of the old signals came back," said lead investigator Dr. Peter Calabresi, professor of neurology at Johns Hopkins University in Baltimore.

"There were some second-degree AV blocks in a small proportion of patients," 1-3%, he said. There were also dose-dependent, mostly reversible increases in liver function test results during treatment.

"Hypertension was more frequent in this study," as well, Dr. Calabresi said, perhaps because patients had a higher body mass index than in previous trials. The drug’s new labeling notes that about 5% of patients have an approximately 2 mm Hg rise in systolic pressure and 1 mm Hg rise in diastolic pressure after the first month of treatment.

Basal cell carcinoma, macular edema, and herpes zoster and lower respiratory infections were also slightly more frequent in fingolimod patients. Although two patients died in previous trials, there were no deaths in the most recent trial.

It’s "an individual conversation between the doctor and the patient" whether or not to use the drug. "Hopefully the doctor knows that patient well. If you already have hypertension or a history of MI or stroke, you shouldn’t go on this drug. The drug’s known to cause bradycardia and, in some cases, first- and second-degree AV block," Dr. Calabresi said.

Dr. Calabresi reported that he has received personal compensation for activities with Teva, Biogen Idec, Novartis, Genzyme, Johnson & Johnson, Vertex, Abbott, Genentech, and Merck Serono, and that he has received research support from Biogen Idec, Teva, EMD Serono, Vertex, Genentech, Abbott, and Bayer.

Every patient should get an electrocardiogram prior to and 6 hours after the first dose of fingolimod, and hourly blood pressure and heart rate measurements in between, to assess for bradycardia, according to revised labeling released by the Food and Drug Administration on May 9.

Patients with prolonged QTc intervals during the observation period should be observed overnight with continuous ECG monitoring, labeling now states.

The revisions come after more than a dozen reports of sudden or unexplained deaths in the United States and Europe following the drug’s 2010 approval for relapsing forms of multiple sclerosis, and months-long talks between the FDA and Novartis, the maker of fingolimod (Gilenya). Previous labeling recommended baseline ECGs only "in those at higher risk of bradyarrhythmia."

--------------------------------------------------------------------------------------------------

• 

     Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

--------------------------------------------------------------------------------------------------

Novartis noted in a press release that fingolimod has been used in more than 36,000 patients.

Labeling also now calls for overnight, continuous ECG monitoring in a medical facility for patients with preexisting heart conditions, cerebrovascular disease, recurrent syncope, or severe untreated sleep apnea; patients on beta-blockers or other drugs that slow heart rate or atrioventricular (AV) conduction; and patients with prolonged QTc intervals, whether due to drugs or medical conditions. ECG monitoring is also warranted, in some cases, for patients restarting the drug after a pause.

"Isolated delayed onset events, including transient asystole and unexplained death, have occurred within 24 hours of the first dose," the revised labeling notes, although the relationship with fingolimod is "uncertain."

The new label contraindicates the drug in patients who, in the last 6 months, have had a heart attack, unstable angina, stroke, transient ischemic attack, second- or third-degree AV block, decompensated heart failure requiring hospitalization, sick sinus syndrome with no pacemaker, baseline QTc interval of 500 ms or longer, and treatment with class Ia or class III antiarrhythmic drugs. Previous labeling had no contraindications.

Those and other changes come shortly after the annual meeting of the American Academy of Neurology, where Novartis released the results of its recent 2-year, double-blind, placebo-controlled, multicenter, phase III trial of fingolimod in 1,083 patients with relapsing-remitting multiple sclerosis.

At month 24, 0.5 mg of fingolimod once daily significantly reduced patients’ annualized relapse rates by 48% versus placebo. Fingolimod patients also had a statistically significant reduction in brain volume loss.

Those results are consistent with previous trials of the drug (N. Engl. J. Med. 2010;362:387-401; N. Engl. J. Med. 2006;355:1124-40). But in contrast to those studies, fingolimod did not show a statistically significant benefit over placebo on 2-year EDSS (Expanded Disability Status Scale) disability progression.

Overall, "there were probably not any new [safety] signals" in the recent trial, "but some of the old signals came back," said lead investigator Dr. Peter Calabresi, professor of neurology at Johns Hopkins University in Baltimore.

"There were some second-degree AV blocks in a small proportion of patients," 1-3%, he said. There were also dose-dependent, mostly reversible increases in liver function test results during treatment.

"Hypertension was more frequent in this study," as well, Dr. Calabresi said, perhaps because patients had a higher body mass index than in previous trials. The drug’s new labeling notes that about 5% of patients have an approximately 2 mm Hg rise in systolic pressure and 1 mm Hg rise in diastolic pressure after the first month of treatment.

Basal cell carcinoma, macular edema, and herpes zoster and lower respiratory infections were also slightly more frequent in fingolimod patients. Although two patients died in previous trials, there were no deaths in the most recent trial.

It’s "an individual conversation between the doctor and the patient" whether or not to use the drug. "Hopefully the doctor knows that patient well. If you already have hypertension or a history of MI or stroke, you shouldn’t go on this drug. The drug’s known to cause bradycardia and, in some cases, first- and second-degree AV block," Dr. Calabresi said.

Dr. Calabresi reported that he has received personal compensation for activities with Teva, Biogen Idec, Novartis, Genzyme, Johnson & Johnson, Vertex, Abbott, Genentech, and Merck Serono, and that he has received research support from Biogen Idec, Teva, EMD Serono, Vertex, Genentech, Abbott, and Bayer.

Every patient should get an electrocardiogram prior to and 6 hours after the first dose of fingolimod, and hourly blood pressure and heart rate measurements in between, to assess for bradycardia, according to revised labeling released by the Food and Drug Administration on May 9.

Patients with prolonged QTc intervals during the observation period should be observed overnight with continuous ECG monitoring, labeling now states.

The revisions come after more than a dozen reports of sudden or unexplained deaths in the United States and Europe following the drug’s 2010 approval for relapsing forms of multiple sclerosis, and months-long talks between the FDA and Novartis, the maker of fingolimod (Gilenya). Previous labeling recommended baseline ECGs only "in those at higher risk of bradyarrhythmia."

--------------------------------------------------------------------------------------------------

• 

     Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

--------------------------------------------------------------------------------------------------

Novartis noted in a press release that fingolimod has been used in more than 36,000 patients.

Labeling also now calls for overnight, continuous ECG monitoring in a medical facility for patients with preexisting heart conditions, cerebrovascular disease, recurrent syncope, or severe untreated sleep apnea; patients on beta-blockers or other drugs that slow heart rate or atrioventricular (AV) conduction; and patients with prolonged QTc intervals, whether due to drugs or medical conditions. ECG monitoring is also warranted, in some cases, for patients restarting the drug after a pause.

"Isolated delayed onset events, including transient asystole and unexplained death, have occurred within 24 hours of the first dose," the revised labeling notes, although the relationship with fingolimod is "uncertain."

The new label contraindicates the drug in patients who, in the last 6 months, have had a heart attack, unstable angina, stroke, transient ischemic attack, second- or third-degree AV block, decompensated heart failure requiring hospitalization, sick sinus syndrome with no pacemaker, baseline QTc interval of 500 ms or longer, and treatment with class Ia or class III antiarrhythmic drugs. Previous labeling had no contraindications.

Those and other changes come shortly after the annual meeting of the American Academy of Neurology, where Novartis released the results of its recent 2-year, double-blind, placebo-controlled, multicenter, phase III trial of fingolimod in 1,083 patients with relapsing-remitting multiple sclerosis.

At month 24, 0.5 mg of fingolimod once daily significantly reduced patients’ annualized relapse rates by 48% versus placebo. Fingolimod patients also had a statistically significant reduction in brain volume loss.

Those results are consistent with previous trials of the drug (N. Engl. J. Med. 2010;362:387-401; N. Engl. J. Med. 2006;355:1124-40). But in contrast to those studies, fingolimod did not show a statistically significant benefit over placebo on 2-year EDSS (Expanded Disability Status Scale) disability progression.

Overall, "there were probably not any new [safety] signals" in the recent trial, "but some of the old signals came back," said lead investigator Dr. Peter Calabresi, professor of neurology at Johns Hopkins University in Baltimore.

"There were some second-degree AV blocks in a small proportion of patients," 1-3%, he said. There were also dose-dependent, mostly reversible increases in liver function test results during treatment.

"Hypertension was more frequent in this study," as well, Dr. Calabresi said, perhaps because patients had a higher body mass index than in previous trials. The drug’s new labeling notes that about 5% of patients have an approximately 2 mm Hg rise in systolic pressure and 1 mm Hg rise in diastolic pressure after the first month of treatment.

Basal cell carcinoma, macular edema, and herpes zoster and lower respiratory infections were also slightly more frequent in fingolimod patients. Although two patients died in previous trials, there were no deaths in the most recent trial.

It’s "an individual conversation between the doctor and the patient" whether or not to use the drug. "Hopefully the doctor knows that patient well. If you already have hypertension or a history of MI or stroke, you shouldn’t go on this drug. The drug’s known to cause bradycardia and, in some cases, first- and second-degree AV block," Dr. Calabresi said.

Dr. Calabresi reported that he has received personal compensation for activities with Teva, Biogen Idec, Novartis, Genzyme, Johnson & Johnson, Vertex, Abbott, Genentech, and Merck Serono, and that he has received research support from Biogen Idec, Teva, EMD Serono, Vertex, Genentech, Abbott, and Bayer.

SAN DIEGO – Terlipressin, widely used in Europe for hepatorenal syndrome but not yet approved in the United States, would be a useful option for this difficult-to-treat condition, said transplant hepatologist Dr. James Burton at the annual meeting of the Society of Hospital Medicine.

Currently, U.S. clinicians do their best with albumin and vasoconstrictors such as octreotide and midodrine to counteract the intense splanchnic vasodilatation that causes the condition (J. Clin. Gastroenterol. 2009;43:680-5).

Hepatorenal syndrome is a complication of advanced cirrhosis that can lead to renal failure. Liver transplantation is "the only treatment we currently have available to us that is very effective," especially for rapidly progressing type 1 HRS [hepatorenal syndrome]," said Dr. Burton, associate professor of medicine and the medical director of liver transplantation at the University of Colorado Hospital, Aurora.

The European vasopressin analogue terlipressin (Lucassin) has a long half-life that allows for bolus dosing every 4-6 hours. Several studies found evidence that the drug might be beneficial.

In one study, 56 patients with type 1 HRS were randomized to terlipressin (1 mg intravenously every 6 hours) plus albumin. Another 56 patients received placebo plus albumin.

Serum creatinine level decreased to 1.5 mg/dL or less in 14 (25%) terlipressin patients, but in only 7 (12.5%) placebo patients by day 14. This difference was not statistically significant, however. The two groups had similar adverse event rates (Gastroenterology 2008;134:1360-8).

A significant benefit was found in a randomized study of 46 patients. Serum creatinine fell below 1.5 mg/dL or decreased 50% from baseline in 10 (43.5%) patients treated with albumin and terlipressin (1-2 mg/4 hours), vs. 2 (8.7%) patients treated with albumin alone (P = .017). Ten terlipressin patients and four albumin-only patients had cardiovascular complications (Gastroenterology 2008;134:1352-9).

In a third study, which was also randomized, 24 HRS patients received albumin and terlipressin (3 mg/24 hours with escalation based on response) and 17 received standard U.S. treatment – albumin plus midodrine and octreotide, also escalated according to response.

Serum creatinine in that study fell below 1.5 mg/dL in 13 (54%) terlipressin patients and renal function improved in three-quarters. Creatinine fell below 1.5 mg/dL in just 2 (12%) of the standard-treatment patients, and renal function improved in about a third (Angeli et al. The Liver Meeting 2011, American Association for the Study of Liver Diseases).

However, in all three studies, people didn’t live any longer when they were given terlipressin, and this is what is holding up FDA approval, said Dr. Burton, who noted that he and his colleagues are working on a new study "to try to show a survival benefit" for the drug.

He said he hopes the FDA approves terlipressin "because it will be a very effective treatment for hepatorenal syndrome. It would be amazing and wonderful if I could prevent people from going on dialysis" as they wait for a new liver.

Dr. Burton said he has no relevant financial disclosures.

SAN DIEGO – Terlipressin, widely used in Europe for hepatorenal syndrome but not yet approved in the United States, would be a useful option for this difficult-to-treat condition, said transplant hepatologist Dr. James Burton at the annual meeting of the Society of Hospital Medicine.

Currently, U.S. clinicians do their best with albumin and vasoconstrictors such as octreotide and midodrine to counteract the intense splanchnic vasodilatation that causes the condition (J. Clin. Gastroenterol. 2009;43:680-5).

Hepatorenal syndrome is a complication of advanced cirrhosis that can lead to renal failure. Liver transplantation is "the only treatment we currently have available to us that is very effective," especially for rapidly progressing type 1 HRS [hepatorenal syndrome]," said Dr. Burton, associate professor of medicine and the medical director of liver transplantation at the University of Colorado Hospital, Aurora.

The European vasopressin analogue terlipressin (Lucassin) has a long half-life that allows for bolus dosing every 4-6 hours. Several studies found evidence that the drug might be beneficial.

In one study, 56 patients with type 1 HRS were randomized to terlipressin (1 mg intravenously every 6 hours) plus albumin. Another 56 patients received placebo plus albumin.

Serum creatinine level decreased to 1.5 mg/dL or less in 14 (25%) terlipressin patients, but in only 7 (12.5%) placebo patients by day 14. This difference was not statistically significant, however. The two groups had similar adverse event rates (Gastroenterology 2008;134:1360-8).

A significant benefit was found in a randomized study of 46 patients. Serum creatinine fell below 1.5 mg/dL or decreased 50% from baseline in 10 (43.5%) patients treated with albumin and terlipressin (1-2 mg/4 hours), vs. 2 (8.7%) patients treated with albumin alone (P = .017). Ten terlipressin patients and four albumin-only patients had cardiovascular complications (Gastroenterology 2008;134:1352-9).

In a third study, which was also randomized, 24 HRS patients received albumin and terlipressin (3 mg/24 hours with escalation based on response) and 17 received standard U.S. treatment – albumin plus midodrine and octreotide, also escalated according to response.

Serum creatinine in that study fell below 1.5 mg/dL in 13 (54%) terlipressin patients and renal function improved in three-quarters. Creatinine fell below 1.5 mg/dL in just 2 (12%) of the standard-treatment patients, and renal function improved in about a third (Angeli et al. The Liver Meeting 2011, American Association for the Study of Liver Diseases).

However, in all three studies, people didn’t live any longer when they were given terlipressin, and this is what is holding up FDA approval, said Dr. Burton, who noted that he and his colleagues are working on a new study "to try to show a survival benefit" for the drug.

He said he hopes the FDA approves terlipressin "because it will be a very effective treatment for hepatorenal syndrome. It would be amazing and wonderful if I could prevent people from going on dialysis" as they wait for a new liver.

Dr. Burton said he has no relevant financial disclosures.

SAN DIEGO – Terlipressin, widely used in Europe for hepatorenal syndrome but not yet approved in the United States, would be a useful option for this difficult-to-treat condition, said transplant hepatologist Dr. James Burton at the annual meeting of the Society of Hospital Medicine.

Currently, U.S. clinicians do their best with albumin and vasoconstrictors such as octreotide and midodrine to counteract the intense splanchnic vasodilatation that causes the condition (J. Clin. Gastroenterol. 2009;43:680-5).

Hepatorenal syndrome is a complication of advanced cirrhosis that can lead to renal failure. Liver transplantation is "the only treatment we currently have available to us that is very effective," especially for rapidly progressing type 1 HRS [hepatorenal syndrome]," said Dr. Burton, associate professor of medicine and the medical director of liver transplantation at the University of Colorado Hospital, Aurora.

The European vasopressin analogue terlipressin (Lucassin) has a long half-life that allows for bolus dosing every 4-6 hours. Several studies found evidence that the drug might be beneficial.

In one study, 56 patients with type 1 HRS were randomized to terlipressin (1 mg intravenously every 6 hours) plus albumin. Another 56 patients received placebo plus albumin.

Serum creatinine level decreased to 1.5 mg/dL or less in 14 (25%) terlipressin patients, but in only 7 (12.5%) placebo patients by day 14. This difference was not statistically significant, however. The two groups had similar adverse event rates (Gastroenterology 2008;134:1360-8).

A significant benefit was found in a randomized study of 46 patients. Serum creatinine fell below 1.5 mg/dL or decreased 50% from baseline in 10 (43.5%) patients treated with albumin and terlipressin (1-2 mg/4 hours), vs. 2 (8.7%) patients treated with albumin alone (P = .017). Ten terlipressin patients and four albumin-only patients had cardiovascular complications (Gastroenterology 2008;134:1352-9).

In a third study, which was also randomized, 24 HRS patients received albumin and terlipressin (3 mg/24 hours with escalation based on response) and 17 received standard U.S. treatment – albumin plus midodrine and octreotide, also escalated according to response.

Serum creatinine in that study fell below 1.5 mg/dL in 13 (54%) terlipressin patients and renal function improved in three-quarters. Creatinine fell below 1.5 mg/dL in just 2 (12%) of the standard-treatment patients, and renal function improved in about a third (Angeli et al. The Liver Meeting 2011, American Association for the Study of Liver Diseases).

However, in all three studies, people didn’t live any longer when they were given terlipressin, and this is what is holding up FDA approval, said Dr. Burton, who noted that he and his colleagues are working on a new study "to try to show a survival benefit" for the drug.

He said he hopes the FDA approves terlipressin "because it will be a very effective treatment for hepatorenal syndrome. It would be amazing and wonderful if I could prevent people from going on dialysis" as they wait for a new liver.

Dr. Burton said he has no relevant financial disclosures.

LAS VEGAS -- Percutaneous covered stents safely and effectively bypass and seal off pseudoaneurysms in arteriovenous grafts and fistulas, preventing rupture, prolonging hemodialysis access, and eliminating the need for open surgical repair, a prospective study of 24 patients has found.

"Endograft exclusion of PSAs [pseudoaneurysms] is a practical approach to solving a not uncommonly encountered clinical problem in this complex patient population. Patients avoid complications related to [surgery], and are able to maintain an uninterrupted dialysis pattern" without the use of a central venous catheter, lead investigator Alison Kinning said at the annual meeting of the Society for Clinical Vascular Surgery.

Twenty of the patients had arteriovenous grafts, four had arteriovenous fistulas, and all had at least one pseudoaneurysm. The patients were stented with Fluency e-polytetrafluoroethylene–covered nitinol stents using a bareback technique.

A 6-French sheath was placed after removal of the stent delivery catheter, and angioplasty was used in order to pleat out and fix the stent in place, with angioplasty for outflow stenosis also done as needed. Blood was drawn out of the aneurysm after the stent was in place in order to relieve skin tension.

"We allowed immediate [dialysis] cannulation, including the stented segment, following endograft placement. We did mark the center of the stent so as to avoid cannulation [of its ends]," noted Ms. Kinning, a third-year medical student at the American University of the Caribbean in St. Maarten.

Primary assisted patency was 100% in the 20 patients who completed a 2-month follow-up and in the 13 who completed a 6-month follow-up. The mean duration of patency was 17.6 months, and the longest duration of patency was 6 years, 4 months.

However, after 2 months one patient asked to have the stent removed because of pain, and two patients were restented after their initial stents fractured.

Five stented grafts had to be removed after a mean of 2.4 months because of infection. The cause of the infections is uncertain, but these probably occurred because of repeated cannulations, diabetes, poor personal hygiene, or other factors.

"Sometimes, the infection may have already started [before stenting], but you’ve at least prevented the [graft] from rupturing. Sometimes the stent will help you control an emergent or threatening situation and give you time to plan a repair or bypass if needed," said coauthor Dr. Wayne Kinning, a vascular surgeon in Flint, Mich., and Ms. Kinning’s father.

A handful of other studies have supported the use of stents in order to treat pseudoaneurysms.

One such study found that infections were associated with skin erosion over the aneurysm. In this retrospective review of medical records by Dr. Aamir Shah, patients with a PSA underwent endovascular repair using a stent graft. The indications for repair included PSA with symptoms, PSA with skin erosion, PSA with failed hemodialysis, and PSA after balloon angioplasty of a stenosis. (J. Vasc. Surg. 2012 [doi:10.1016/j.jjvs.2011.10.126]).

The procedure "probably will become increasingly recommended. I think that’s the shift that’s happening," said Dr. Kinning.

Ms. Kinning and Dr. Kinning said they had no relevant disclosures.

LAS VEGAS -- Percutaneous covered stents safely and effectively bypass and seal off pseudoaneurysms in arteriovenous grafts and fistulas, preventing rupture, prolonging hemodialysis access, and eliminating the need for open surgical repair, a prospective study of 24 patients has found.

"Endograft exclusion of PSAs [pseudoaneurysms] is a practical approach to solving a not uncommonly encountered clinical problem in this complex patient population. Patients avoid complications related to [surgery], and are able to maintain an uninterrupted dialysis pattern" without the use of a central venous catheter, lead investigator Alison Kinning said at the annual meeting of the Society for Clinical Vascular Surgery.

Twenty of the patients had arteriovenous grafts, four had arteriovenous fistulas, and all had at least one pseudoaneurysm. The patients were stented with Fluency e-polytetrafluoroethylene–covered nitinol stents using a bareback technique.

A 6-French sheath was placed after removal of the stent delivery catheter, and angioplasty was used in order to pleat out and fix the stent in place, with angioplasty for outflow stenosis also done as needed. Blood was drawn out of the aneurysm after the stent was in place in order to relieve skin tension.

"We allowed immediate [dialysis] cannulation, including the stented segment, following endograft placement. We did mark the center of the stent so as to avoid cannulation [of its ends]," noted Ms. Kinning, a third-year medical student at the American University of the Caribbean in St. Maarten.

Primary assisted patency was 100% in the 20 patients who completed a 2-month follow-up and in the 13 who completed a 6-month follow-up. The mean duration of patency was 17.6 months, and the longest duration of patency was 6 years, 4 months.

However, after 2 months one patient asked to have the stent removed because of pain, and two patients were restented after their initial stents fractured.

Five stented grafts had to be removed after a mean of 2.4 months because of infection. The cause of the infections is uncertain, but these probably occurred because of repeated cannulations, diabetes, poor personal hygiene, or other factors.

"Sometimes, the infection may have already started [before stenting], but you’ve at least prevented the [graft] from rupturing. Sometimes the stent will help you control an emergent or threatening situation and give you time to plan a repair or bypass if needed," said coauthor Dr. Wayne Kinning, a vascular surgeon in Flint, Mich., and Ms. Kinning’s father.

A handful of other studies have supported the use of stents in order to treat pseudoaneurysms.

One such study found that infections were associated with skin erosion over the aneurysm. In this retrospective review of medical records by Dr. Aamir Shah, patients with a PSA underwent endovascular repair using a stent graft. The indications for repair included PSA with symptoms, PSA with skin erosion, PSA with failed hemodialysis, and PSA after balloon angioplasty of a stenosis. (J. Vasc. Surg. 2012 [doi:10.1016/j.jjvs.2011.10.126]).

The procedure "probably will become increasingly recommended. I think that’s the shift that’s happening," said Dr. Kinning.

Ms. Kinning and Dr. Kinning said they had no relevant disclosures.

LAS VEGAS -- Percutaneous covered stents safely and effectively bypass and seal off pseudoaneurysms in arteriovenous grafts and fistulas, preventing rupture, prolonging hemodialysis access, and eliminating the need for open surgical repair, a prospective study of 24 patients has found.

"Endograft exclusion of PSAs [pseudoaneurysms] is a practical approach to solving a not uncommonly encountered clinical problem in this complex patient population. Patients avoid complications related to [surgery], and are able to maintain an uninterrupted dialysis pattern" without the use of a central venous catheter, lead investigator Alison Kinning said at the annual meeting of the Society for Clinical Vascular Surgery.

Twenty of the patients had arteriovenous grafts, four had arteriovenous fistulas, and all had at least one pseudoaneurysm. The patients were stented with Fluency e-polytetrafluoroethylene–covered nitinol stents using a bareback technique.

A 6-French sheath was placed after removal of the stent delivery catheter, and angioplasty was used in order to pleat out and fix the stent in place, with angioplasty for outflow stenosis also done as needed. Blood was drawn out of the aneurysm after the stent was in place in order to relieve skin tension.

"We allowed immediate [dialysis] cannulation, including the stented segment, following endograft placement. We did mark the center of the stent so as to avoid cannulation [of its ends]," noted Ms. Kinning, a third-year medical student at the American University of the Caribbean in St. Maarten.

Primary assisted patency was 100% in the 20 patients who completed a 2-month follow-up and in the 13 who completed a 6-month follow-up. The mean duration of patency was 17.6 months, and the longest duration of patency was 6 years, 4 months.

However, after 2 months one patient asked to have the stent removed because of pain, and two patients were restented after their initial stents fractured.

Five stented grafts had to be removed after a mean of 2.4 months because of infection. The cause of the infections is uncertain, but these probably occurred because of repeated cannulations, diabetes, poor personal hygiene, or other factors.

"Sometimes, the infection may have already started [before stenting], but you’ve at least prevented the [graft] from rupturing. Sometimes the stent will help you control an emergent or threatening situation and give you time to plan a repair or bypass if needed," said coauthor Dr. Wayne Kinning, a vascular surgeon in Flint, Mich., and Ms. Kinning’s father.

A handful of other studies have supported the use of stents in order to treat pseudoaneurysms.

One such study found that infections were associated with skin erosion over the aneurysm. In this retrospective review of medical records by Dr. Aamir Shah, patients with a PSA underwent endovascular repair using a stent graft. The indications for repair included PSA with symptoms, PSA with skin erosion, PSA with failed hemodialysis, and PSA after balloon angioplasty of a stenosis. (J. Vasc. Surg. 2012 [doi:10.1016/j.jjvs.2011.10.126]).

The procedure "probably will become increasingly recommended. I think that’s the shift that’s happening," said Dr. Kinning.

Ms. Kinning and Dr. Kinning said they had no relevant disclosures.

NEW ORLEANS – It is a good idea to cast a wide net when asking patients with facioscapulohumeral muscular dystrophy about their symptoms because many problems go unrecognized, and some are at least partially treatable, according to a survey of 328 patients in the National Registry of Myotonic Dystrophy and FSHD Patients and Family Members.

For example, patients said not being able to play sports with their children, family, and friends was important. "Dancing is important in this population, too. I would never have guessed it, but it is," said lead investigator Dr. Chad Heatwole, an assistant professor of neurology at the University of Rochester (N.Y.).

For some, not being able to ski or play golf was more important than was difficulty walking.

It might take some creativity to help with such problems, but emotional problems – mostly depression and anxiety – were reported by about 75% of patients, and are readily treated with counseling and medication. These problems "are highly prevalent and an issue we didn’t expect," Dr. Heatwole said at the annual meeting of the American Academy of Neurology.

Usually all we ask is, "How strong are you? Can you go up the stairs?" he said. "These aren’t very amenable to therapy. But pain, fatigue, depression, anxiety, and the different types of emotional problems – you wouldn’t think to ask about these – they’re important but not that addressed."

The roots of the survey were extensive interviews of 20 patients with FSHD (facioscapulohumeral muscular dystrophy) that revealed 250 symptoms and 14 symptom categories of likely importance to the FSHD community. The 328 surveyed patients with FSHD from 46 states had a mean age of 55 years (range, 23-86 years). About half had a job.

More than 90% reported a variety of symptoms and limitations:

• An inability to do previous activities.

• Physical, emotional, or cognitive fatigue.

• Back, chest, or abdominal weakness.

• Mobility or walking limitations.

• Shoulder and arm problems.

• Disease-related changes in body image to the point that patients didn’t like to go swimming because of it.

Shoulder weakness, leg fatigue, decreased range of motion, and inability to exercise were common, as were difficulty lifting objects and reaching overhead items.

Patients said their lives were at least moderately affected by such problems, as well as by difficulty with stairs, inability to run, difficulty thinking, pain, decreased satisfaction in social situations, decreased performance in social situations, and inability to do specific activities. Emotional and communication issues, as well as hand or finger difficulties, also significantly affected patients’ lives. Fatigue and impaired social performance affected women more than men.

Ninety-four percent of patients said they were aware that their disease was getting worse; about 94% also said they feared the progression. About 14% had had their symptoms mistaken for drunkenness, and 64% for another disease; 37% said they try to hide their condition from friends, and 35% reported they have a hard time getting information about FSHD. "We need to do better providing information," Dr. Heatwole said.

Overall, patients were less likely to get further in school if they had difficulty thinking and communicating, or if they had emotional or hand-use problems. Patients with mobility, hand-use, or eating problems were less likely to be employed.

The findings have been turned into a quality of life assessment tool for upcoming FSHD trials, he said.

Dr. Heatwole said that he had no disclosures.

NEW ORLEANS – It is a good idea to cast a wide net when asking patients with facioscapulohumeral muscular dystrophy about their symptoms because many problems go unrecognized, and some are at least partially treatable, according to a survey of 328 patients in the National Registry of Myotonic Dystrophy and FSHD Patients and Family Members.

For example, patients said not being able to play sports with their children, family, and friends was important. "Dancing is important in this population, too. I would never have guessed it, but it is," said lead investigator Dr. Chad Heatwole, an assistant professor of neurology at the University of Rochester (N.Y.).

For some, not being able to ski or play golf was more important than was difficulty walking.

It might take some creativity to help with such problems, but emotional problems – mostly depression and anxiety – were reported by about 75% of patients, and are readily treated with counseling and medication. These problems "are highly prevalent and an issue we didn’t expect," Dr. Heatwole said at the annual meeting of the American Academy of Neurology.

Usually all we ask is, "How strong are you? Can you go up the stairs?" he said. "These aren’t very amenable to therapy. But pain, fatigue, depression, anxiety, and the different types of emotional problems – you wouldn’t think to ask about these – they’re important but not that addressed."

The roots of the survey were extensive interviews of 20 patients with FSHD (facioscapulohumeral muscular dystrophy) that revealed 250 symptoms and 14 symptom categories of likely importance to the FSHD community. The 328 surveyed patients with FSHD from 46 states had a mean age of 55 years (range, 23-86 years). About half had a job.

More than 90% reported a variety of symptoms and limitations:

• An inability to do previous activities.

• Physical, emotional, or cognitive fatigue.

• Back, chest, or abdominal weakness.

• Mobility or walking limitations.

• Shoulder and arm problems.

• Disease-related changes in body image to the point that patients didn’t like to go swimming because of it.

Shoulder weakness, leg fatigue, decreased range of motion, and inability to exercise were common, as were difficulty lifting objects and reaching overhead items.

Patients said their lives were at least moderately affected by such problems, as well as by difficulty with stairs, inability to run, difficulty thinking, pain, decreased satisfaction in social situations, decreased performance in social situations, and inability to do specific activities. Emotional and communication issues, as well as hand or finger difficulties, also significantly affected patients’ lives. Fatigue and impaired social performance affected women more than men.

Ninety-four percent of patients said they were aware that their disease was getting worse; about 94% also said they feared the progression. About 14% had had their symptoms mistaken for drunkenness, and 64% for another disease; 37% said they try to hide their condition from friends, and 35% reported they have a hard time getting information about FSHD. "We need to do better providing information," Dr. Heatwole said.

Overall, patients were less likely to get further in school if they had difficulty thinking and communicating, or if they had emotional or hand-use problems. Patients with mobility, hand-use, or eating problems were less likely to be employed.

The findings have been turned into a quality of life assessment tool for upcoming FSHD trials, he said.

Dr. Heatwole said that he had no disclosures.

NEW ORLEANS – It is a good idea to cast a wide net when asking patients with facioscapulohumeral muscular dystrophy about their symptoms because many problems go unrecognized, and some are at least partially treatable, according to a survey of 328 patients in the National Registry of Myotonic Dystrophy and FSHD Patients and Family Members.

For example, patients said not being able to play sports with their children, family, and friends was important. "Dancing is important in this population, too. I would never have guessed it, but it is," said lead investigator Dr. Chad Heatwole, an assistant professor of neurology at the University of Rochester (N.Y.).

For some, not being able to ski or play golf was more important than was difficulty walking.

It might take some creativity to help with such problems, but emotional problems – mostly depression and anxiety – were reported by about 75% of patients, and are readily treated with counseling and medication. These problems "are highly prevalent and an issue we didn’t expect," Dr. Heatwole said at the annual meeting of the American Academy of Neurology.

Usually all we ask is, "How strong are you? Can you go up the stairs?" he said. "These aren’t very amenable to therapy. But pain, fatigue, depression, anxiety, and the different types of emotional problems – you wouldn’t think to ask about these – they’re important but not that addressed."

The roots of the survey were extensive interviews of 20 patients with FSHD (facioscapulohumeral muscular dystrophy) that revealed 250 symptoms and 14 symptom categories of likely importance to the FSHD community. The 328 surveyed patients with FSHD from 46 states had a mean age of 55 years (range, 23-86 years). About half had a job.

More than 90% reported a variety of symptoms and limitations:

• An inability to do previous activities.

• Physical, emotional, or cognitive fatigue.

• Back, chest, or abdominal weakness.

• Mobility or walking limitations.

• Shoulder and arm problems.

• Disease-related changes in body image to the point that patients didn’t like to go swimming because of it.

Shoulder weakness, leg fatigue, decreased range of motion, and inability to exercise were common, as were difficulty lifting objects and reaching overhead items.

Patients said their lives were at least moderately affected by such problems, as well as by difficulty with stairs, inability to run, difficulty thinking, pain, decreased satisfaction in social situations, decreased performance in social situations, and inability to do specific activities. Emotional and communication issues, as well as hand or finger difficulties, also significantly affected patients’ lives. Fatigue and impaired social performance affected women more than men.

Ninety-four percent of patients said they were aware that their disease was getting worse; about 94% also said they feared the progression. About 14% had had their symptoms mistaken for drunkenness, and 64% for another disease; 37% said they try to hide their condition from friends, and 35% reported they have a hard time getting information about FSHD. "We need to do better providing information," Dr. Heatwole said.

Overall, patients were less likely to get further in school if they had difficulty thinking and communicating, or if they had emotional or hand-use problems. Patients with mobility, hand-use, or eating problems were less likely to be employed.

The findings have been turned into a quality of life assessment tool for upcoming FSHD trials, he said.

Dr. Heatwole said that he had no disclosures.

NEW ORLEANS – When Parkinson’s disease patients are admitted to hospitals, they often end up on incorrect doses of levodopa during their stay – if it’s prescribed at all – and sometimes inappropriately get metoclopramide or neuroleptics, dopamine-blocking agents that could make their disease worse, according to a study from the University of Calgary (Alta.).

That’s what researchers from the university’s Movement Disorders Clinic found when they compared what 44 of their Parkinson’s patients took at home with what they were given after being admitted to Calgary hospitals.

There were medication problems in 44 (80%) of the 55 hospitalizations those patients had in 2010, said lead author Dr. Katie Wiltshire, a neurology resident at the university.

"Our study identifies deficiencies in the in-hospital prescribing of medications for patients with PD [Parkinson’s disease]. This includes a failure to seamlessly continue usual PD medications when patients are admitted, and perhaps of even greater concern, the inappropriate addition of dopamine-blocking agents during their hospital stay," she said at the annual meeting of the American Academy of Neurology.

Similar problems have been found at hospitals in the United States and Britain, perhaps because some hospital services are unfamiliar with PD treatment. "Widespread education of providers and safe-prescribing protocols are urgently needed to address these unsafe care issues," Dr. Wiltshire said.

Patients in her study came in on stable levodopa doses in 53 of the 55 admissions (96.4%); there were subsequent problems with levodopa administration in 26 (49%) of those hospital stays.

During three hospitalizations (5.7%), levodopa was not ordered for people who been on it at home. In 15 of the 53 admissions (28.3%), doses ordered were too high or too low. Dose schedules were off during 8 hospital stays (15.1%). In another12 stays (22.6%), patients were put on either immediate or extended-release levodopa when they had been on the alternate formulation before coming to the hospital. Metoclopramide or neuroleptics were ordered in 24 (43.6%) of the overall 55 admissions.

Dr. Wilshire and her colleagues don’t know yet if the discrepancies hurt patients, but other studies have found that they do, and that many PD patients report bad hospital experiences related to medication mismanagement (Parkinsonism Relat. Disord. 2007;13:539-40; Postgrad. Med. J. 2010;86:334-7). "This is a sobering report," said Dr. Christopher Goetz, director of the Parkinson’s Disease and Movement Disorders program at Rush University in Chicago, who moderated her presentation.

The National Parkinson Foundation is trying to address the problem with an Aware in Care campaign that helps patients and physicians overcome medication challenges during PD hospitalizations.

In Calgary, Dr. Wiltshire and her colleagues are working with the electronic health records system to give admitting physicians access to notes from the Movement Disorders Clinic. "Ideally, we would like to be able to [write the medication orders] and have them sent directly into the admitting orders," Dr. Wiltshire said.

They’ve already put a warning flag in the system that pops up when people order metoclopramide for patients on antiparkinson drugs. They’ve also made sure that immediate-release levodopa comes up first on drug ordering screens. Extended-release levodopa "was coming up first, so that’s what people were clicking," Dr. Wiltshire said.

The team also hopes to give PD patients more control over when they get their medications, perhaps by keeping them on bedside tables, and involve pharmacy staff "right at admission, so that they can work to get the [medication] reconciliation done," she said.

Dr. Wiltshire said she has no disclosures. Dr. Goetz reported personal compensation from several pharmaceutical and medical companies, none of them involved in the study.

NEW ORLEANS – When Parkinson’s disease patients are admitted to hospitals, they often end up on incorrect doses of levodopa during their stay – if it’s prescribed at all – and sometimes inappropriately get metoclopramide or neuroleptics, dopamine-blocking agents that could make their disease worse, according to a study from the University of Calgary (Alta.).

That’s what researchers from the university’s Movement Disorders Clinic found when they compared what 44 of their Parkinson’s patients took at home with what they were given after being admitted to Calgary hospitals.

There were medication problems in 44 (80%) of the 55 hospitalizations those patients had in 2010, said lead author Dr. Katie Wiltshire, a neurology resident at the university.

"Our study identifies deficiencies in the in-hospital prescribing of medications for patients with PD [Parkinson’s disease]. This includes a failure to seamlessly continue usual PD medications when patients are admitted, and perhaps of even greater concern, the inappropriate addition of dopamine-blocking agents during their hospital stay," she said at the annual meeting of the American Academy of Neurology.

Similar problems have been found at hospitals in the United States and Britain, perhaps because some hospital services are unfamiliar with PD treatment. "Widespread education of providers and safe-prescribing protocols are urgently needed to address these unsafe care issues," Dr. Wiltshire said.

Patients in her study came in on stable levodopa doses in 53 of the 55 admissions (96.4%); there were subsequent problems with levodopa administration in 26 (49%) of those hospital stays.

During three hospitalizations (5.7%), levodopa was not ordered for people who been on it at home. In 15 of the 53 admissions (28.3%), doses ordered were too high or too low. Dose schedules were off during 8 hospital stays (15.1%). In another12 stays (22.6%), patients were put on either immediate or extended-release levodopa when they had been on the alternate formulation before coming to the hospital. Metoclopramide or neuroleptics were ordered in 24 (43.6%) of the overall 55 admissions.

Dr. Wilshire and her colleagues don’t know yet if the discrepancies hurt patients, but other studies have found that they do, and that many PD patients report bad hospital experiences related to medication mismanagement (Parkinsonism Relat. Disord. 2007;13:539-40; Postgrad. Med. J. 2010;86:334-7). "This is a sobering report," said Dr. Christopher Goetz, director of the Parkinson’s Disease and Movement Disorders program at Rush University in Chicago, who moderated her presentation.

The National Parkinson Foundation is trying to address the problem with an Aware in Care campaign that helps patients and physicians overcome medication challenges during PD hospitalizations.

In Calgary, Dr. Wiltshire and her colleagues are working with the electronic health records system to give admitting physicians access to notes from the Movement Disorders Clinic. "Ideally, we would like to be able to [write the medication orders] and have them sent directly into the admitting orders," Dr. Wiltshire said.

They’ve already put a warning flag in the system that pops up when people order metoclopramide for patients on antiparkinson drugs. They’ve also made sure that immediate-release levodopa comes up first on drug ordering screens. Extended-release levodopa "was coming up first, so that’s what people were clicking," Dr. Wiltshire said.

The team also hopes to give PD patients more control over when they get their medications, perhaps by keeping them on bedside tables, and involve pharmacy staff "right at admission, so that they can work to get the [medication] reconciliation done," she said.

Dr. Wiltshire said she has no disclosures. Dr. Goetz reported personal compensation from several pharmaceutical and medical companies, none of them involved in the study.

NEW ORLEANS – When Parkinson’s disease patients are admitted to hospitals, they often end up on incorrect doses of levodopa during their stay – if it’s prescribed at all – and sometimes inappropriately get metoclopramide or neuroleptics, dopamine-blocking agents that could make their disease worse, according to a study from the University of Calgary (Alta.).

That’s what researchers from the university’s Movement Disorders Clinic found when they compared what 44 of their Parkinson’s patients took at home with what they were given after being admitted to Calgary hospitals.

There were medication problems in 44 (80%) of the 55 hospitalizations those patients had in 2010, said lead author Dr. Katie Wiltshire, a neurology resident at the university.

"Our study identifies deficiencies in the in-hospital prescribing of medications for patients with PD [Parkinson’s disease]. This includes a failure to seamlessly continue usual PD medications when patients are admitted, and perhaps of even greater concern, the inappropriate addition of dopamine-blocking agents during their hospital stay," she said at the annual meeting of the American Academy of Neurology.

Similar problems have been found at hospitals in the United States and Britain, perhaps because some hospital services are unfamiliar with PD treatment. "Widespread education of providers and safe-prescribing protocols are urgently needed to address these unsafe care issues," Dr. Wiltshire said.

Patients in her study came in on stable levodopa doses in 53 of the 55 admissions (96.4%); there were subsequent problems with levodopa administration in 26 (49%) of those hospital stays.

During three hospitalizations (5.7%), levodopa was not ordered for people who been on it at home. In 15 of the 53 admissions (28.3%), doses ordered were too high or too low. Dose schedules were off during 8 hospital stays (15.1%). In another12 stays (22.6%), patients were put on either immediate or extended-release levodopa when they had been on the alternate formulation before coming to the hospital. Metoclopramide or neuroleptics were ordered in 24 (43.6%) of the overall 55 admissions.

Dr. Wilshire and her colleagues don’t know yet if the discrepancies hurt patients, but other studies have found that they do, and that many PD patients report bad hospital experiences related to medication mismanagement (Parkinsonism Relat. Disord. 2007;13:539-40; Postgrad. Med. J. 2010;86:334-7). "This is a sobering report," said Dr. Christopher Goetz, director of the Parkinson’s Disease and Movement Disorders program at Rush University in Chicago, who moderated her presentation.

The National Parkinson Foundation is trying to address the problem with an Aware in Care campaign that helps patients and physicians overcome medication challenges during PD hospitalizations.

In Calgary, Dr. Wiltshire and her colleagues are working with the electronic health records system to give admitting physicians access to notes from the Movement Disorders Clinic. "Ideally, we would like to be able to [write the medication orders] and have them sent directly into the admitting orders," Dr. Wiltshire said.

They’ve already put a warning flag in the system that pops up when people order metoclopramide for patients on antiparkinson drugs. They’ve also made sure that immediate-release levodopa comes up first on drug ordering screens. Extended-release levodopa "was coming up first, so that’s what people were clicking," Dr. Wiltshire said.

The team also hopes to give PD patients more control over when they get their medications, perhaps by keeping them on bedside tables, and involve pharmacy staff "right at admission, so that they can work to get the [medication] reconciliation done," she said.

Dr. Wiltshire said she has no disclosures. Dr. Goetz reported personal compensation from several pharmaceutical and medical companies, none of them involved in the study.

SAN DIEGO – Infliximab is the optimal rescue therapy for severe, acute, steroid-refractory ulcerative colitis, gastroenterologist Dr. Derek R. Patel said at the annual meeting of the Society of Hospital Medicine.

The tumor necrosis factor–alpha inhibitor, which carries ulcerative colitis (UC) indications, works as well as cyclosporine, the traditional option, without its complications, which include a 1% mortality rate and the need for extensive monitoring.

Infliximab (Remicade) also works better than azathioprine, the agent to which steroid-refractory patients often are switched once they leave the hospital, said Dr. Patel of the department of medicine at the University of California, San Diego.

Alex Otto/IMNG Medical Media

In a randomized trial by Dr. D. Laharie and colleagues that compared infliximab in 56 steroid-refractory UC patients with cyclosporine in 55 similar patients, about 85% of those in each arm responded to treatment within 1 week; 10 (18%) of the cyclosporine patients and 13 (23%) in the infliximab group had undergone a colectomy by the third month of follow-up. Serious adverse events were reported in 9 (16%) cyclosporine patients and 16 (29%) infliximab patients. There were no deaths.

"If you look at all the important end points, whether they be early response, overall treatment failure, or colectomy, there are no significant short-term differences between cyclosporine and infliximab, suggesting that infliximab is not inferior to cyclosporine. [It also] is much easier to use and requires minimal monitoring," Dr. Patel said.

"I think infliximab would be the optimal medical rescue therapy for these patients" in most cases, he said.

Another study – a 16-week, randomized, double-blind, controlled trial by Dr. R. Panccione and colleagues – compared azathioprine monotherapy, infliximab monotherapy, and combination therapy in 239 steroid-refractory UC patients.

"In the two most important end points of steroid-free clinical remission and mucosal healing, infliximab-based therapy, whether monotherapy or combination therapy, was significantly better than azathioprine monotherapy," Dr. Patel said.

Steroid failure can generally be predicted after 3 days of treatment by the Travis or Lindgren indexes, which take into account number of bowel movements per day, C-reactive protein levels, and other factors. Those and other indexes "allow you to move on to medical or surgical rescue therapy early on," he said.

"But remember medical therapy isn’t for everyone. Some patients probably should have a colectomy," despite the possible complications, Dr. Patel cautioned.

Patients who are likely to need surgery include those with massive unrelenting hemorrhage, toxic megacolon, coexisting cancer or dysplasia, and intractable UC of long duration, as well as noncompliant patients.

"Patients and physicians alike tend to assume surgery is failure, [but] that’s not true. At the end of the day, our goal is to save lives and quality of life, not necessarily colons," Dr. Patel said.

Dr. Patel said he has no disclosures.

SAN DIEGO – Infliximab is the optimal rescue therapy for severe, acute, steroid-refractory ulcerative colitis, gastroenterologist Dr. Derek R. Patel said at the annual meeting of the Society of Hospital Medicine.

The tumor necrosis factor–alpha inhibitor, which carries ulcerative colitis (UC) indications, works as well as cyclosporine, the traditional option, without its complications, which include a 1% mortality rate and the need for extensive monitoring.

Infliximab (Remicade) also works better than azathioprine, the agent to which steroid-refractory patients often are switched once they leave the hospital, said Dr. Patel of the department of medicine at the University of California, San Diego.

Alex Otto/IMNG Medical Media

In a randomized trial by Dr. D. Laharie and colleagues that compared infliximab in 56 steroid-refractory UC patients with cyclosporine in 55 similar patients, about 85% of those in each arm responded to treatment within 1 week; 10 (18%) of the cyclosporine patients and 13 (23%) in the infliximab group had undergone a colectomy by the third month of follow-up. Serious adverse events were reported in 9 (16%) cyclosporine patients and 16 (29%) infliximab patients. There were no deaths.

"If you look at all the important end points, whether they be early response, overall treatment failure, or colectomy, there are no significant short-term differences between cyclosporine and infliximab, suggesting that infliximab is not inferior to cyclosporine. [It also] is much easier to use and requires minimal monitoring," Dr. Patel said.

"I think infliximab would be the optimal medical rescue therapy for these patients" in most cases, he said.

Another study – a 16-week, randomized, double-blind, controlled trial by Dr. R. Panccione and colleagues – compared azathioprine monotherapy, infliximab monotherapy, and combination therapy in 239 steroid-refractory UC patients.

"In the two most important end points of steroid-free clinical remission and mucosal healing, infliximab-based therapy, whether monotherapy or combination therapy, was significantly better than azathioprine monotherapy," Dr. Patel said.

Steroid failure can generally be predicted after 3 days of treatment by the Travis or Lindgren indexes, which take into account number of bowel movements per day, C-reactive protein levels, and other factors. Those and other indexes "allow you to move on to medical or surgical rescue therapy early on," he said.

"But remember medical therapy isn’t for everyone. Some patients probably should have a colectomy," despite the possible complications, Dr. Patel cautioned.

Patients who are likely to need surgery include those with massive unrelenting hemorrhage, toxic megacolon, coexisting cancer or dysplasia, and intractable UC of long duration, as well as noncompliant patients.

"Patients and physicians alike tend to assume surgery is failure, [but] that’s not true. At the end of the day, our goal is to save lives and quality of life, not necessarily colons," Dr. Patel said.

Dr. Patel said he has no disclosures.

SAN DIEGO – Infliximab is the optimal rescue therapy for severe, acute, steroid-refractory ulcerative colitis, gastroenterologist Dr. Derek R. Patel said at the annual meeting of the Society of Hospital Medicine.

The tumor necrosis factor–alpha inhibitor, which carries ulcerative colitis (UC) indications, works as well as cyclosporine, the traditional option, without its complications, which include a 1% mortality rate and the need for extensive monitoring.

Infliximab (Remicade) also works better than azathioprine, the agent to which steroid-refractory patients often are switched once they leave the hospital, said Dr. Patel of the department of medicine at the University of California, San Diego.

Alex Otto/IMNG Medical Media

In a randomized trial by Dr. D. Laharie and colleagues that compared infliximab in 56 steroid-refractory UC patients with cyclosporine in 55 similar patients, about 85% of those in each arm responded to treatment within 1 week; 10 (18%) of the cyclosporine patients and 13 (23%) in the infliximab group had undergone a colectomy by the third month of follow-up. Serious adverse events were reported in 9 (16%) cyclosporine patients and 16 (29%) infliximab patients. There were no deaths.

"If you look at all the important end points, whether they be early response, overall treatment failure, or colectomy, there are no significant short-term differences between cyclosporine and infliximab, suggesting that infliximab is not inferior to cyclosporine. [It also] is much easier to use and requires minimal monitoring," Dr. Patel said.

"I think infliximab would be the optimal medical rescue therapy for these patients" in most cases, he said.

Another study – a 16-week, randomized, double-blind, controlled trial by Dr. R. Panccione and colleagues – compared azathioprine monotherapy, infliximab monotherapy, and combination therapy in 239 steroid-refractory UC patients.

"In the two most important end points of steroid-free clinical remission and mucosal healing, infliximab-based therapy, whether monotherapy or combination therapy, was significantly better than azathioprine monotherapy," Dr. Patel said.

Steroid failure can generally be predicted after 3 days of treatment by the Travis or Lindgren indexes, which take into account number of bowel movements per day, C-reactive protein levels, and other factors. Those and other indexes "allow you to move on to medical or surgical rescue therapy early on," he said.

"But remember medical therapy isn’t for everyone. Some patients probably should have a colectomy," despite the possible complications, Dr. Patel cautioned.

Patients who are likely to need surgery include those with massive unrelenting hemorrhage, toxic megacolon, coexisting cancer or dysplasia, and intractable UC of long duration, as well as noncompliant patients.

"Patients and physicians alike tend to assume surgery is failure, [but] that’s not true. At the end of the day, our goal is to save lives and quality of life, not necessarily colons," Dr. Patel said.

Dr. Patel said he has no disclosures.

SAN DIEGO – Before treating Clostridium difficile, ask which test was used for diagnosis. For methicillin-resistant Staphylococcus aureus pneumonia, know that linezolid is now in the arsenal and that vancomycin dosing has changed.

These words of advice came from Dr. John Bartlett, professor of medicine and former chief of the division of infectious diseases at Johns Hopkins University, Baltimore, at a session on recent developments in infectious disease.

NIAID/RML

"When somebody tells you a patient has a positive C. difficile test, or a negative C. difficile test, your next question is ‘what test,’ " Dr. Bartlett said.

About half of U.S. hospitals use polymerase chain reaction (PCR) to diagnose C. diff., the other half, enzyme immunoassay (EIA), he said.

"PCR is exquisitely sensitive. It is very good for ruling it out, but there [are] false positives. EIA goes in the opposite direction. It’s not sensitive; it’s pretty good for specificity, [but] remember that if it’s a negative EIA, you have not excluded the diagnosis. EIA rules it in, PCR rules it out."

Increasingly, patients are colonized with C. diff. before they reach the hospital, probably from previous health care contact. Avoiding proton-pump inhibitors and antibiotics associated with C. diff. infection – cephalosporins, clindamycin, and fluoroquinolones – are wise moves for high-risk patients. Opiates should be avoided, too, because they cause intestinal stasis, he said.

It might take a while for the infection to respond to antibiotics; fecal transplantation is quicker.

"Fecal transplant is hot," Dr. Bartlett said. "The aesthetics" are lacking, but "it really works. Take a patient who has 10 relapses of C. diff., put in somebody else’s stool" – often delivered as a slurry through a nasogastric tube – "and the next bowel movement is normal. The biologic response is fantastic. It’s mostly done for patients who have multiple relapses, but it’s also been done in very refractory patients and those who are seriously ill," Dr. Bartlett said (Anaerobe 2009;15:285-9).

There’s a new colon-sparing surgical option for critically ill patients, diverting loop ileostomy with colonic lavage. Mortality rates are substantially lower, compared with traditional colon resection (Ann. Surg. 2011;254:423-7).

"You look at it and you say, ‘My God, why didn’t they think of this before?" Dr. Bartlett said.

There’s a new antibiotic choice, as well, after the Food and Drug Administration approved fidaxomicin for C. diff. in 2011. It has about the same cure rate as oral vancomycin, but fewer relapses, which may be "where this drug plays an important role," Dr. Bartlett said (N. Engl. J. Med. 2011;364:422-31).

For methicillin-resistant S. aureus (MRSA) pneumonia, it’s important to remember that dosing guidelines have changed for treating bacterium with vancomycin, he said.

"Five years ago, everybody with MRSA got one gram twice a day. Now we are saying give vancomycin in a dose that achieves a trough level of 15-20 mcg/mL; if the minimum inhibitory concentration is" greater than 2 mcg/mL, "maybe you ought to give something else," he said (Clin. Infect. Dis. 2009;49:325-7; Clin. Infect. Dis. 2011;52:285-92).

And there now appears to be an alternative to vancomycin on the MRSA scene, Dr. Bartlett explained. In a head-to-head trial, linezolid "looked at least as good as vancomycin. There ought to be a comfort zone for that drug in MRSA pneumonia" (Clin. Infect. Dis. 2012;54:621-9).

The USA300 strain now accounts for about 30% of hospital MRSA infections; the balance remain mostly "the old USA100 strain. MRSA acquired outside the hospital is more likely to be USA300, inside the hospital more likely to be USA100.

"There’s not an awful lot you need to know about the differences between them," except [that] USA300, in addition to being sensitive to USA100 antibiotics, can also be treated with trimethoprim/sulfamethoxazole, doxycycline, and clindamycin, Dr. Bartlett said.

Dr. Bartlett said he has no relevant financial disclosures.

SAN DIEGO – Before treating Clostridium difficile, ask which test was used for diagnosis. For methicillin-resistant Staphylococcus aureus pneumonia, know that linezolid is now in the arsenal and that vancomycin dosing has changed.

These words of advice came from Dr. John Bartlett, professor of medicine and former chief of the division of infectious diseases at Johns Hopkins University, Baltimore, at a session on recent developments in infectious disease.

NIAID/RML

"When somebody tells you a patient has a positive C. difficile test, or a negative C. difficile test, your next question is ‘what test,’ " Dr. Bartlett said.

About half of U.S. hospitals use polymerase chain reaction (PCR) to diagnose C. diff., the other half, enzyme immunoassay (EIA), he said.

"PCR is exquisitely sensitive. It is very good for ruling it out, but there [are] false positives. EIA goes in the opposite direction. It’s not sensitive; it’s pretty good for specificity, [but] remember that if it’s a negative EIA, you have not excluded the diagnosis. EIA rules it in, PCR rules it out."

Increasingly, patients are colonized with C. diff. before they reach the hospital, probably from previous health care contact. Avoiding proton-pump inhibitors and antibiotics associated with C. diff. infection – cephalosporins, clindamycin, and fluoroquinolones – are wise moves for high-risk patients. Opiates should be avoided, too, because they cause intestinal stasis, he said.

It might take a while for the infection to respond to antibiotics; fecal transplantation is quicker.

"Fecal transplant is hot," Dr. Bartlett said. "The aesthetics" are lacking, but "it really works. Take a patient who has 10 relapses of C. diff., put in somebody else’s stool" – often delivered as a slurry through a nasogastric tube – "and the next bowel movement is normal. The biologic response is fantastic. It’s mostly done for patients who have multiple relapses, but it’s also been done in very refractory patients and those who are seriously ill," Dr. Bartlett said (Anaerobe 2009;15:285-9).

There’s a new colon-sparing surgical option for critically ill patients, diverting loop ileostomy with colonic lavage. Mortality rates are substantially lower, compared with traditional colon resection (Ann. Surg. 2011;254:423-7).

"You look at it and you say, ‘My God, why didn’t they think of this before?" Dr. Bartlett said.

There’s a new antibiotic choice, as well, after the Food and Drug Administration approved fidaxomicin for C. diff. in 2011. It has about the same cure rate as oral vancomycin, but fewer relapses, which may be "where this drug plays an important role," Dr. Bartlett said (N. Engl. J. Med. 2011;364:422-31).

For methicillin-resistant S. aureus (MRSA) pneumonia, it’s important to remember that dosing guidelines have changed for treating bacterium with vancomycin, he said.

"Five years ago, everybody with MRSA got one gram twice a day. Now we are saying give vancomycin in a dose that achieves a trough level of 15-20 mcg/mL; if the minimum inhibitory concentration is" greater than 2 mcg/mL, "maybe you ought to give something else," he said (Clin. Infect. Dis. 2009;49:325-7; Clin. Infect. Dis. 2011;52:285-92).

And there now appears to be an alternative to vancomycin on the MRSA scene, Dr. Bartlett explained. In a head-to-head trial, linezolid "looked at least as good as vancomycin. There ought to be a comfort zone for that drug in MRSA pneumonia" (Clin. Infect. Dis. 2012;54:621-9).

The USA300 strain now accounts for about 30% of hospital MRSA infections; the balance remain mostly "the old USA100 strain. MRSA acquired outside the hospital is more likely to be USA300, inside the hospital more likely to be USA100.

"There’s not an awful lot you need to know about the differences between them," except [that] USA300, in addition to being sensitive to USA100 antibiotics, can also be treated with trimethoprim/sulfamethoxazole, doxycycline, and clindamycin, Dr. Bartlett said.

Dr. Bartlett said he has no relevant financial disclosures.

SAN DIEGO – Before treating Clostridium difficile, ask which test was used for diagnosis. For methicillin-resistant Staphylococcus aureus pneumonia, know that linezolid is now in the arsenal and that vancomycin dosing has changed.

These words of advice came from Dr. John Bartlett, professor of medicine and former chief of the division of infectious diseases at Johns Hopkins University, Baltimore, at a session on recent developments in infectious disease.

NIAID/RML

"When somebody tells you a patient has a positive C. difficile test, or a negative C. difficile test, your next question is ‘what test,’ " Dr. Bartlett said.

About half of U.S. hospitals use polymerase chain reaction (PCR) to diagnose C. diff., the other half, enzyme immunoassay (EIA), he said.

"PCR is exquisitely sensitive. It is very good for ruling it out, but there [are] false positives. EIA goes in the opposite direction. It’s not sensitive; it’s pretty good for specificity, [but] remember that if it’s a negative EIA, you have not excluded the diagnosis. EIA rules it in, PCR rules it out."

Increasingly, patients are colonized with C. diff. before they reach the hospital, probably from previous health care contact. Avoiding proton-pump inhibitors and antibiotics associated with C. diff. infection – cephalosporins, clindamycin, and fluoroquinolones – are wise moves for high-risk patients. Opiates should be avoided, too, because they cause intestinal stasis, he said.

It might take a while for the infection to respond to antibiotics; fecal transplantation is quicker.

"Fecal transplant is hot," Dr. Bartlett said. "The aesthetics" are lacking, but "it really works. Take a patient who has 10 relapses of C. diff., put in somebody else’s stool" – often delivered as a slurry through a nasogastric tube – "and the next bowel movement is normal. The biologic response is fantastic. It’s mostly done for patients who have multiple relapses, but it’s also been done in very refractory patients and those who are seriously ill," Dr. Bartlett said (Anaerobe 2009;15:285-9).

There’s a new colon-sparing surgical option for critically ill patients, diverting loop ileostomy with colonic lavage. Mortality rates are substantially lower, compared with traditional colon resection (Ann. Surg. 2011;254:423-7).

"You look at it and you say, ‘My God, why didn’t they think of this before?" Dr. Bartlett said.

There’s a new antibiotic choice, as well, after the Food and Drug Administration approved fidaxomicin for C. diff. in 2011. It has about the same cure rate as oral vancomycin, but fewer relapses, which may be "where this drug plays an important role," Dr. Bartlett said (N. Engl. J. Med. 2011;364:422-31).

For methicillin-resistant S. aureus (MRSA) pneumonia, it’s important to remember that dosing guidelines have changed for treating bacterium with vancomycin, he said.

"Five years ago, everybody with MRSA got one gram twice a day. Now we are saying give vancomycin in a dose that achieves a trough level of 15-20 mcg/mL; if the minimum inhibitory concentration is" greater than 2 mcg/mL, "maybe you ought to give something else," he said (Clin. Infect. Dis. 2009;49:325-7; Clin. Infect. Dis. 2011;52:285-92).

And there now appears to be an alternative to vancomycin on the MRSA scene, Dr. Bartlett explained. In a head-to-head trial, linezolid "looked at least as good as vancomycin. There ought to be a comfort zone for that drug in MRSA pneumonia" (Clin. Infect. Dis. 2012;54:621-9).

The USA300 strain now accounts for about 30% of hospital MRSA infections; the balance remain mostly "the old USA100 strain. MRSA acquired outside the hospital is more likely to be USA300, inside the hospital more likely to be USA100.

"There’s not an awful lot you need to know about the differences between them," except [that] USA300, in addition to being sensitive to USA100 antibiotics, can also be treated with trimethoprim/sulfamethoxazole, doxycycline, and clindamycin, Dr. Bartlett said.

Dr. Bartlett said he has no relevant financial disclosures.

NEW ORLEANS – Topiramate joins divalproex sodium, sodium valproate, metoprolol, propranolol, and timolol – plus the herbal supplement petasites, an extract of the butterbur plant – as a top choice for migraine prevention in newly updated guidelines from the American Academy of Neurology and the American Headache Society.

All are "effective for migraine prevention and should be offered to patients with migraine to reduce migraine attack frequency and severity," the guidelines state.

"We didn’t have good evidence for topiramate" for the previous guidelines, published in 2000. "We do now," said lead author Dr. Stephen Silberstein, a professor of neurology at Jefferson Medical College in Philadelphia.

That evidence includes a study that found that 50 mg/day for 8 weeks reduced migraine frequency from a baseline of about six per month to about two, and decreased headache intensity and duration (Acta. Neurol. Scand. 2008;118:301-5).

Meanwhile, "we’ve downgraded verapamil and gabapentin because we didn’t have enough evidence" to maintain a strong recommendation, said Dr. Silberstein, who is also the director of the Jefferson Headache Center.

The guidelines were updated to incorporate newer studies, and include advice on about 40 drugs and 20 mostly over-the-counter (OTC) products, including NSAIDs, culled from the strongest of almost 300 studies. Frovatriptan was also found to be effective for preventing menstrual migraines.

"We used stricter criteria this time than we did the last time, and included a lot more details for over-the-counter [products] and nutraceuticals. We also provided the evidence for [why] certain drugs have proven not to be really effective, such as carbamazepine and lamotrigine," which appears to be "good for [migraine] aura, but not for the headache," Dr. Silberstein said in an interview.

Overall, the drug recommendations probably won’t surprise too many doctors, but will support "what they believe, and give them evidence for what they practice," he said.

However, "the fact that there’s such good evidence for butterbur" – the only OTC product listed as effective for migraine prevention, instead of "probably" or "possibly" effective – may be "new to doctors," he said.

One study found that 75 mg twice daily reduced migraine attack frequency by 48%, significantly better than placebo (Neurology 2004;63:2240-4).

"It’s a surprise to many physicians that some of the [nonpharmaceuticals] actually work," Dr. Silberstein said.

With so many drugs and OTC products in play, selection depends largely on side effect profiles and patient comorbidities.

Topiramate, for example, might make sense for obese patients because it helps with weight loss. It and valproate might also be wise choices for epileptics. Beta-blockers might be the way to go for patients with anxiety or essential tremors, but not if they have asthma.

Prophylaxis makes sense when people have one or more attacks a week; when acute medications fail or are used too much; and when migraines come with a prolonged aura or worrisome neurological symptoms, such as hemiparesis, Dr. Silberstein said.

Total health care costs go down when migraines are prevented, despite the upfront cost of the drugs, he noted (Headache 2003;43:171-8).

Dr. Silberstein is on the advisory panel of and receives honoraria from AGA, Allergan, Amgen, Capnia, Coherex, Colucid, Cydex, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, Minster, Neuralieve, NuPathe, Pfizer, St. Jude Medical, and Valeant. He is on the speakers bureau of and receives honoraria from Endo Pharmaceuticals, GlaxoSmithKline, and Merck. He serves as a consultant for and receives honoraria from Amgen and Novartis. His employer receives research support from AGA, Allergan, Boston Scientific, Capnia, Coherex, Endo Pharmaceuticals, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, the National Institute of Neurological Disorders and Stroke, NuPathe, St. Jude Medical, and Valeant Pharmaceuticals. Other authors also reported numerous financial relationships with companies that manufacture drugs used in migraine prevention.

NEW ORLEANS – Topiramate joins divalproex sodium, sodium valproate, metoprolol, propranolol, and timolol – plus the herbal supplement petasites, an extract of the butterbur plant – as a top choice for migraine prevention in newly updated guidelines from the American Academy of Neurology and the American Headache Society.

All are "effective for migraine prevention and should be offered to patients with migraine to reduce migraine attack frequency and severity," the guidelines state.

"We didn’t have good evidence for topiramate" for the previous guidelines, published in 2000. "We do now," said lead author Dr. Stephen Silberstein, a professor of neurology at Jefferson Medical College in Philadelphia.

That evidence includes a study that found that 50 mg/day for 8 weeks reduced migraine frequency from a baseline of about six per month to about two, and decreased headache intensity and duration (Acta. Neurol. Scand. 2008;118:301-5).

Meanwhile, "we’ve downgraded verapamil and gabapentin because we didn’t have enough evidence" to maintain a strong recommendation, said Dr. Silberstein, who is also the director of the Jefferson Headache Center.

The guidelines were updated to incorporate newer studies, and include advice on about 40 drugs and 20 mostly over-the-counter (OTC) products, including NSAIDs, culled from the strongest of almost 300 studies. Frovatriptan was also found to be effective for preventing menstrual migraines.

"We used stricter criteria this time than we did the last time, and included a lot more details for over-the-counter [products] and nutraceuticals. We also provided the evidence for [why] certain drugs have proven not to be really effective, such as carbamazepine and lamotrigine," which appears to be "good for [migraine] aura, but not for the headache," Dr. Silberstein said in an interview.

Overall, the drug recommendations probably won’t surprise too many doctors, but will support "what they believe, and give them evidence for what they practice," he said.

However, "the fact that there’s such good evidence for butterbur" – the only OTC product listed as effective for migraine prevention, instead of "probably" or "possibly" effective – may be "new to doctors," he said.

One study found that 75 mg twice daily reduced migraine attack frequency by 48%, significantly better than placebo (Neurology 2004;63:2240-4).

"It’s a surprise to many physicians that some of the [nonpharmaceuticals] actually work," Dr. Silberstein said.

With so many drugs and OTC products in play, selection depends largely on side effect profiles and patient comorbidities.

Topiramate, for example, might make sense for obese patients because it helps with weight loss. It and valproate might also be wise choices for epileptics. Beta-blockers might be the way to go for patients with anxiety or essential tremors, but not if they have asthma.

Prophylaxis makes sense when people have one or more attacks a week; when acute medications fail or are used too much; and when migraines come with a prolonged aura or worrisome neurological symptoms, such as hemiparesis, Dr. Silberstein said.

Total health care costs go down when migraines are prevented, despite the upfront cost of the drugs, he noted (Headache 2003;43:171-8).

Dr. Silberstein is on the advisory panel of and receives honoraria from AGA, Allergan, Amgen, Capnia, Coherex, Colucid, Cydex, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, Minster, Neuralieve, NuPathe, Pfizer, St. Jude Medical, and Valeant. He is on the speakers bureau of and receives honoraria from Endo Pharmaceuticals, GlaxoSmithKline, and Merck. He serves as a consultant for and receives honoraria from Amgen and Novartis. His employer receives research support from AGA, Allergan, Boston Scientific, Capnia, Coherex, Endo Pharmaceuticals, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, the National Institute of Neurological Disorders and Stroke, NuPathe, St. Jude Medical, and Valeant Pharmaceuticals. Other authors also reported numerous financial relationships with companies that manufacture drugs used in migraine prevention.

NEW ORLEANS – Topiramate joins divalproex sodium, sodium valproate, metoprolol, propranolol, and timolol – plus the herbal supplement petasites, an extract of the butterbur plant – as a top choice for migraine prevention in newly updated guidelines from the American Academy of Neurology and the American Headache Society.

All are "effective for migraine prevention and should be offered to patients with migraine to reduce migraine attack frequency and severity," the guidelines state.

"We didn’t have good evidence for topiramate" for the previous guidelines, published in 2000. "We do now," said lead author Dr. Stephen Silberstein, a professor of neurology at Jefferson Medical College in Philadelphia.

That evidence includes a study that found that 50 mg/day for 8 weeks reduced migraine frequency from a baseline of about six per month to about two, and decreased headache intensity and duration (Acta. Neurol. Scand. 2008;118:301-5).

Meanwhile, "we’ve downgraded verapamil and gabapentin because we didn’t have enough evidence" to maintain a strong recommendation, said Dr. Silberstein, who is also the director of the Jefferson Headache Center.

The guidelines were updated to incorporate newer studies, and include advice on about 40 drugs and 20 mostly over-the-counter (OTC) products, including NSAIDs, culled from the strongest of almost 300 studies. Frovatriptan was also found to be effective for preventing menstrual migraines.

"We used stricter criteria this time than we did the last time, and included a lot more details for over-the-counter [products] and nutraceuticals. We also provided the evidence for [why] certain drugs have proven not to be really effective, such as carbamazepine and lamotrigine," which appears to be "good for [migraine] aura, but not for the headache," Dr. Silberstein said in an interview.

Overall, the drug recommendations probably won’t surprise too many doctors, but will support "what they believe, and give them evidence for what they practice," he said.

However, "the fact that there’s such good evidence for butterbur" – the only OTC product listed as effective for migraine prevention, instead of "probably" or "possibly" effective – may be "new to doctors," he said.

One study found that 75 mg twice daily reduced migraine attack frequency by 48%, significantly better than placebo (Neurology 2004;63:2240-4).

"It’s a surprise to many physicians that some of the [nonpharmaceuticals] actually work," Dr. Silberstein said.

With so many drugs and OTC products in play, selection depends largely on side effect profiles and patient comorbidities.

Topiramate, for example, might make sense for obese patients because it helps with weight loss. It and valproate might also be wise choices for epileptics. Beta-blockers might be the way to go for patients with anxiety or essential tremors, but not if they have asthma.

Prophylaxis makes sense when people have one or more attacks a week; when acute medications fail or are used too much; and when migraines come with a prolonged aura or worrisome neurological symptoms, such as hemiparesis, Dr. Silberstein said.

Total health care costs go down when migraines are prevented, despite the upfront cost of the drugs, he noted (Headache 2003;43:171-8).

Dr. Silberstein is on the advisory panel of and receives honoraria from AGA, Allergan, Amgen, Capnia, Coherex, Colucid, Cydex, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, Minster, Neuralieve, NuPathe, Pfizer, St. Jude Medical, and Valeant. He is on the speakers bureau of and receives honoraria from Endo Pharmaceuticals, GlaxoSmithKline, and Merck. He serves as a consultant for and receives honoraria from Amgen and Novartis. His employer receives research support from AGA, Allergan, Boston Scientific, Capnia, Coherex, Endo Pharmaceuticals, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, the National Institute of Neurological Disorders and Stroke, NuPathe, St. Jude Medical, and Valeant Pharmaceuticals. Other authors also reported numerous financial relationships with companies that manufacture drugs used in migraine prevention.

SAN DIEGO – A Glasgow-Blatchford bleeding score of zero identifies a subset of upper GI bleeders who can be sent home from the ED and safely managed as outpatients, according to gastroenterologist Dr. Derek Patel at the annual meeting of the Society of Hospital Medicine.

"Less than 1% of patients you send home with a Blatchford score of zero will require" therapeutic endoscopy, transfusion, or surgery. A zero score is "a reasonable predictor for not requiring therapeutic intervention," said Dr. Patel, associate clinical professor of medicine at the University of California, San Diego.

The scale was specifically designed to predict who’ll need intervention for upper GI bleeding. A score of zero translates to a blood urea nitrogen (BUN) below 18.2 mg/dL; hemoglobin of at least 13 g/dL for men and 12 g/dL for women; systolic blood pressure above 109 mmHg; pulse below 100 bpm; no melena at presentation; and no syncope, liver disease, or heart failure.

In a Hong Kong study with 1,087 upper-GI bleed patients undergoing endoscopy within 24 hours of hospital admission, none of the 50 who met those requirements turned out to need therapeutic intervention (Gastrointest. Endosc. 2010;71:1134-40).

Another study found a zero score to be 99.6% sensitive for not needing intervention, with a negative likelihood ratio of 0.02. That’s "probably about as good as it gets for predicting which upper GI bleed patients will not require therapeutic intervention," Dr. Patel said (JAMA 2012;307:1072-9).

Typically, people with an upper GI bleed, regardless of their Blatchford score, are admitted from the ED and evaluated by endoscopy within 24 hours. "Most of those patients will have clean-based ulcers or nothing that needs intervention. We’ll give them a [proton-pump inhibitor], shake their hands, and send them home the next day," he said.

The alternative is to send zero-score patients home instead of admitting them. "Maybe you are going to pick off 20% of your upper-GI bleed population. This has a pretty big financial impact as well as an impact on hospital utilization." However, physicians may be wary of the approach because, for now, "none of the major GI societies in their guidelines for upper GI bleeds even mention the potential of sending patients home," Dr. Patel said.

But British researchers recently found the approach works. Of about 560 people presenting with upper-GI bleeds, 123 had zero scores; 84 were sent home and managed as outpatients without complications (Lancet 2009;373:42-7).

It’s a different situation for acute, significant, lower GI-bleeds. "Data are lacking to support outpatient management," Dr. Patel noted.

Dr. Patel said he has no disclosures.

SAN DIEGO – A Glasgow-Blatchford bleeding score of zero identifies a subset of upper GI bleeders who can be sent home from the ED and safely managed as outpatients, according to gastroenterologist Dr. Derek Patel at the annual meeting of the Society of Hospital Medicine.

"Less than 1% of patients you send home with a Blatchford score of zero will require" therapeutic endoscopy, transfusion, or surgery. A zero score is "a reasonable predictor for not requiring therapeutic intervention," said Dr. Patel, associate clinical professor of medicine at the University of California, San Diego.

The scale was specifically designed to predict who’ll need intervention for upper GI bleeding. A score of zero translates to a blood urea nitrogen (BUN) below 18.2 mg/dL; hemoglobin of at least 13 g/dL for men and 12 g/dL for women; systolic blood pressure above 109 mmHg; pulse below 100 bpm; no melena at presentation; and no syncope, liver disease, or heart failure.

In a Hong Kong study with 1,087 upper-GI bleed patients undergoing endoscopy within 24 hours of hospital admission, none of the 50 who met those requirements turned out to need therapeutic intervention (Gastrointest. Endosc. 2010;71:1134-40).

Another study found a zero score to be 99.6% sensitive for not needing intervention, with a negative likelihood ratio of 0.02. That’s "probably about as good as it gets for predicting which upper GI bleed patients will not require therapeutic intervention," Dr. Patel said (JAMA 2012;307:1072-9).

Typically, people with an upper GI bleed, regardless of their Blatchford score, are admitted from the ED and evaluated by endoscopy within 24 hours. "Most of those patients will have clean-based ulcers or nothing that needs intervention. We’ll give them a [proton-pump inhibitor], shake their hands, and send them home the next day," he said.

The alternative is to send zero-score patients home instead of admitting them. "Maybe you are going to pick off 20% of your upper-GI bleed population. This has a pretty big financial impact as well as an impact on hospital utilization." However, physicians may be wary of the approach because, for now, "none of the major GI societies in their guidelines for upper GI bleeds even mention the potential of sending patients home," Dr. Patel said.

But British researchers recently found the approach works. Of about 560 people presenting with upper-GI bleeds, 123 had zero scores; 84 were sent home and managed as outpatients without complications (Lancet 2009;373:42-7).

It’s a different situation for acute, significant, lower GI-bleeds. "Data are lacking to support outpatient management," Dr. Patel noted.

Dr. Patel said he has no disclosures.

SAN DIEGO – A Glasgow-Blatchford bleeding score of zero identifies a subset of upper GI bleeders who can be sent home from the ED and safely managed as outpatients, according to gastroenterologist Dr. Derek Patel at the annual meeting of the Society of Hospital Medicine.

"Less than 1% of patients you send home with a Blatchford score of zero will require" therapeutic endoscopy, transfusion, or surgery. A zero score is "a reasonable predictor for not requiring therapeutic intervention," said Dr. Patel, associate clinical professor of medicine at the University of California, San Diego.

The scale was specifically designed to predict who’ll need intervention for upper GI bleeding. A score of zero translates to a blood urea nitrogen (BUN) below 18.2 mg/dL; hemoglobin of at least 13 g/dL for men and 12 g/dL for women; systolic blood pressure above 109 mmHg; pulse below 100 bpm; no melena at presentation; and no syncope, liver disease, or heart failure.

In a Hong Kong study with 1,087 upper-GI bleed patients undergoing endoscopy within 24 hours of hospital admission, none of the 50 who met those requirements turned out to need therapeutic intervention (Gastrointest. Endosc. 2010;71:1134-40).

Another study found a zero score to be 99.6% sensitive for not needing intervention, with a negative likelihood ratio of 0.02. That’s "probably about as good as it gets for predicting which upper GI bleed patients will not require therapeutic intervention," Dr. Patel said (JAMA 2012;307:1072-9).

Typically, people with an upper GI bleed, regardless of their Blatchford score, are admitted from the ED and evaluated by endoscopy within 24 hours. "Most of those patients will have clean-based ulcers or nothing that needs intervention. We’ll give them a [proton-pump inhibitor], shake their hands, and send them home the next day," he said.

The alternative is to send zero-score patients home instead of admitting them. "Maybe you are going to pick off 20% of your upper-GI bleed population. This has a pretty big financial impact as well as an impact on hospital utilization." However, physicians may be wary of the approach because, for now, "none of the major GI societies in their guidelines for upper GI bleeds even mention the potential of sending patients home," Dr. Patel said.

But British researchers recently found the approach works. Of about 560 people presenting with upper-GI bleeds, 123 had zero scores; 84 were sent home and managed as outpatients without complications (Lancet 2009;373:42-7).

It’s a different situation for acute, significant, lower GI-bleeds. "Data are lacking to support outpatient management," Dr. Patel noted.

Dr. Patel said he has no disclosures.