This month, Dr David Henry of The Journal of Community and Supportive Oncology examines the use olaparib, which was recently approved for the treatment of BRCA-mutated advanced ovarian cancer, as well as four Original Research articles that focus on patient care, support, and quality of life. There’s a comparison of the antiemetic efficacy and safety of palonosetron and ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children; a study that looks at the rationale, dosimetric parameters, and preliminary clinical outcomes in patients who undergo postoperative stereotactic radiosurgery with simultaneous integrated boost for brain metastases; an examination of the impact of nurse navigation on the timeliness of diagnostic medical services in patients with newly diagnosed lung cancer; and a study that draws on a novel approach to improving end-of-life care by measuring patterns of care among recently deceased patients. The podcast concludes with a round-up of some recent studies on cardiovascular disease in oncology, including the toxicity of cancer therapy and treatment guidelines from the American Society of Clinical Oncology.

This month, Dr David Henry of The Journal of Community and Supportive Oncology examines the use olaparib, which was recently approved for the treatment of BRCA-mutated advanced ovarian cancer, as well as four Original Research articles that focus on patient care, support, and quality of life. There’s a comparison of the antiemetic efficacy and safety of palonosetron and ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children; a study that looks at the rationale, dosimetric parameters, and preliminary clinical outcomes in patients who undergo postoperative stereotactic radiosurgery with simultaneous integrated boost for brain metastases; an examination of the impact of nurse navigation on the timeliness of diagnostic medical services in patients with newly diagnosed lung cancer; and a study that draws on a novel approach to improving end-of-life care by measuring patterns of care among recently deceased patients. The podcast concludes with a round-up of some recent studies on cardiovascular disease in oncology, including the toxicity of cancer therapy and treatment guidelines from the American Society of Clinical Oncology.

This month, Dr David Henry of The Journal of Community and Supportive Oncology examines the use olaparib, which was recently approved for the treatment of BRCA-mutated advanced ovarian cancer, as well as four Original Research articles that focus on patient care, support, and quality of life. There’s a comparison of the antiemetic efficacy and safety of palonosetron and ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children; a study that looks at the rationale, dosimetric parameters, and preliminary clinical outcomes in patients who undergo postoperative stereotactic radiosurgery with simultaneous integrated boost for brain metastases; an examination of the impact of nurse navigation on the timeliness of diagnostic medical services in patients with newly diagnosed lung cancer; and a study that draws on a novel approach to improving end-of-life care by measuring patterns of care among recently deceased patients. The podcast concludes with a round-up of some recent studies on cardiovascular disease in oncology, including the toxicity of cancer therapy and treatment guidelines from the American Society of Clinical Oncology.

WASHINGTON – Regardless of the number of tests and tools for helping to diagnose pediatric sports concussions, Dr. Christopher Giza, professor of pediatric neurology and neurosurgery at the University of California, Los Angeles, says it’s important for clinicians to remember that “concussion is a clinical diagnosis.”

In this video interview recorded at Summit in Neurology & Psychiatry, Dr. Giza offers pearls and insights into the latest in sports concussion management. He describes the four “Rs” of treating sports concussions and urges primary care personnel to offer anticipatory guidance to patients and their families. Such guidance can lead to a 20% decrease in chronic postconcussion syndrome in children and adolescents, he said at the meeting held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

WASHINGTON – Regardless of the number of tests and tools for helping to diagnose pediatric sports concussions, Dr. Christopher Giza, professor of pediatric neurology and neurosurgery at the University of California, Los Angeles, says it’s important for clinicians to remember that “concussion is a clinical diagnosis.”

In this video interview recorded at Summit in Neurology & Psychiatry, Dr. Giza offers pearls and insights into the latest in sports concussion management. He describes the four “Rs” of treating sports concussions and urges primary care personnel to offer anticipatory guidance to patients and their families. Such guidance can lead to a 20% decrease in chronic postconcussion syndrome in children and adolescents, he said at the meeting held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

WASHINGTON – Regardless of the number of tests and tools for helping to diagnose pediatric sports concussions, Dr. Christopher Giza, professor of pediatric neurology and neurosurgery at the University of California, Los Angeles, says it’s important for clinicians to remember that “concussion is a clinical diagnosis.”

In this video interview recorded at Summit in Neurology & Psychiatry, Dr. Giza offers pearls and insights into the latest in sports concussion management. He describes the four “Rs” of treating sports concussions and urges primary care personnel to offer anticipatory guidance to patients and their families. Such guidance can lead to a 20% decrease in chronic postconcussion syndrome in children and adolescents, he said at the meeting held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

WASHINGTON – Two weeks of antibiotic therapy with rifaximin provided relief from functional dyspepsia symptoms in a phase III double-blind, randomized trial.

“This is the first study that demonstrates that rifaximin is efficacious in the treatment of functional dyspepsia, particularly for global dyspeptic symptoms, bloating, and possibly belching. Our finding may suggest a role for the gut microbiota in the pathogenesis of functional dyspepsia,” Dr. Victoria Tan said at the annual Digestive Disease Week.

Patrice Wendling/Frontline Medical News

Rifaximin (Xifaxan) works by reducing or altering bacteria in the gut and has been shown to be efficacious in the treatment of diarrhea-predominant irritable bowel syndrome. It is approved to treat traveler’s diarrhea caused by Escherichia coli and to prevent hepatic encephalopathy.

The study randomly assigned 95 consecutive adults with functional dyspepsia as per ROME III criteria who had a normal gastroscopy within the last 2 years, had active symptoms in the month prior to enrollment, and were Helicobacter pylori negative, to rifaximin 400 mg or placebo three times a day for 2 weeks. In all, 33 rifaximin and 39 placebo patients were evaluable for the primary efficacy outcome of adequate relief of global dyspeptic symptoms (either no or mild dyspeptic symptoms) at any of the follow-up time points.

At baseline, 77% of patients had moderate to severe global dyspepsia symptoms, 74% of the placebo group and 55%% of the rifaximin group had moderate to severe belching, and roughly half of all patients were not on any GI medications. Mean age of the patients was 52 years.

Global dyspepsia symptoms improved with rifaximin beginning at week 2 and significantly favored rifaximin by week 8, with 23.5% of rifaximin patients reporting moderate to severe symptoms compared with 47.4% given placebo (P value = .04), said Dr. Tan of the University of Hong Kong.

Rates of moderate to severe belching were significantly improved with rifaximin at week 4 compared with placebo (14.3% vs. 35.7%; P = .03), but this difference was no longer significant at week 8 (26.5% vs. 29%).

The story was similar for moderate to severe bloating: Rates declined significantly with rifaximin at week 4 (20% vs. 43%; P = .03), but were no longer significant at week 8 (26.5% vs. 34.2%), she said.

A subgroup analysis of female patients showed significant improvements in moderate to severe global dyspeptic symptoms with rifaximin compared with placebo at week 4 (20.8% vs. 59.4%; P = .006) and week 8 (20% vs. 48.4%; P = .048).

Treatment response was not reflected in change in hydrogen breath response, Dr. Tan said. Results of a 3-hour hydrogen breath test performed after a 12-hour overnight fast showed no differences between the rifaximin and placebo groups for H₂ peak above baseline (2.94 ppm vs. 0.11 ppm; P = .29), H₂ area under the curve (+43.64 ppm vs. –49.71 ppm; P = .76), and oro-cecal transit time (24.23 minutes vs. 16.5 minutes; P = .68).

Adverse events were very similar between the two groups at both 4 and 8 weeks, Dr. Tan said. Only one major event occurred, a severe case of acute hepatitis in a woman in the placebo arm who also took traditional Chinese herbs.

pwendling@frontlinemedcom.com

On Twitter @pwendl

WASHINGTON – Two weeks of antibiotic therapy with rifaximin provided relief from functional dyspepsia symptoms in a phase III double-blind, randomized trial.

“This is the first study that demonstrates that rifaximin is efficacious in the treatment of functional dyspepsia, particularly for global dyspeptic symptoms, bloating, and possibly belching. Our finding may suggest a role for the gut microbiota in the pathogenesis of functional dyspepsia,” Dr. Victoria Tan said at the annual Digestive Disease Week.

Patrice Wendling/Frontline Medical News

Rifaximin (Xifaxan) works by reducing or altering bacteria in the gut and has been shown to be efficacious in the treatment of diarrhea-predominant irritable bowel syndrome. It is approved to treat traveler’s diarrhea caused by Escherichia coli and to prevent hepatic encephalopathy.

The study randomly assigned 95 consecutive adults with functional dyspepsia as per ROME III criteria who had a normal gastroscopy within the last 2 years, had active symptoms in the month prior to enrollment, and were Helicobacter pylori negative, to rifaximin 400 mg or placebo three times a day for 2 weeks. In all, 33 rifaximin and 39 placebo patients were evaluable for the primary efficacy outcome of adequate relief of global dyspeptic symptoms (either no or mild dyspeptic symptoms) at any of the follow-up time points.

At baseline, 77% of patients had moderate to severe global dyspepsia symptoms, 74% of the placebo group and 55%% of the rifaximin group had moderate to severe belching, and roughly half of all patients were not on any GI medications. Mean age of the patients was 52 years.

Global dyspepsia symptoms improved with rifaximin beginning at week 2 and significantly favored rifaximin by week 8, with 23.5% of rifaximin patients reporting moderate to severe symptoms compared with 47.4% given placebo (P value = .04), said Dr. Tan of the University of Hong Kong.

Rates of moderate to severe belching were significantly improved with rifaximin at week 4 compared with placebo (14.3% vs. 35.7%; P = .03), but this difference was no longer significant at week 8 (26.5% vs. 29%).

The story was similar for moderate to severe bloating: Rates declined significantly with rifaximin at week 4 (20% vs. 43%; P = .03), but were no longer significant at week 8 (26.5% vs. 34.2%), she said.

A subgroup analysis of female patients showed significant improvements in moderate to severe global dyspeptic symptoms with rifaximin compared with placebo at week 4 (20.8% vs. 59.4%; P = .006) and week 8 (20% vs. 48.4%; P = .048).

Treatment response was not reflected in change in hydrogen breath response, Dr. Tan said. Results of a 3-hour hydrogen breath test performed after a 12-hour overnight fast showed no differences between the rifaximin and placebo groups for H₂ peak above baseline (2.94 ppm vs. 0.11 ppm; P = .29), H₂ area under the curve (+43.64 ppm vs. –49.71 ppm; P = .76), and oro-cecal transit time (24.23 minutes vs. 16.5 minutes; P = .68).

Adverse events were very similar between the two groups at both 4 and 8 weeks, Dr. Tan said. Only one major event occurred, a severe case of acute hepatitis in a woman in the placebo arm who also took traditional Chinese herbs.

pwendling@frontlinemedcom.com

On Twitter @pwendl

WASHINGTON – Two weeks of antibiotic therapy with rifaximin provided relief from functional dyspepsia symptoms in a phase III double-blind, randomized trial.

“This is the first study that demonstrates that rifaximin is efficacious in the treatment of functional dyspepsia, particularly for global dyspeptic symptoms, bloating, and possibly belching. Our finding may suggest a role for the gut microbiota in the pathogenesis of functional dyspepsia,” Dr. Victoria Tan said at the annual Digestive Disease Week.

Patrice Wendling/Frontline Medical News

Rifaximin (Xifaxan) works by reducing or altering bacteria in the gut and has been shown to be efficacious in the treatment of diarrhea-predominant irritable bowel syndrome. It is approved to treat traveler’s diarrhea caused by Escherichia coli and to prevent hepatic encephalopathy.

The study randomly assigned 95 consecutive adults with functional dyspepsia as per ROME III criteria who had a normal gastroscopy within the last 2 years, had active symptoms in the month prior to enrollment, and were Helicobacter pylori negative, to rifaximin 400 mg or placebo three times a day for 2 weeks. In all, 33 rifaximin and 39 placebo patients were evaluable for the primary efficacy outcome of adequate relief of global dyspeptic symptoms (either no or mild dyspeptic symptoms) at any of the follow-up time points.

At baseline, 77% of patients had moderate to severe global dyspepsia symptoms, 74% of the placebo group and 55%% of the rifaximin group had moderate to severe belching, and roughly half of all patients were not on any GI medications. Mean age of the patients was 52 years.

Global dyspepsia symptoms improved with rifaximin beginning at week 2 and significantly favored rifaximin by week 8, with 23.5% of rifaximin patients reporting moderate to severe symptoms compared with 47.4% given placebo (P value = .04), said Dr. Tan of the University of Hong Kong.

Rates of moderate to severe belching were significantly improved with rifaximin at week 4 compared with placebo (14.3% vs. 35.7%; P = .03), but this difference was no longer significant at week 8 (26.5% vs. 29%).

The story was similar for moderate to severe bloating: Rates declined significantly with rifaximin at week 4 (20% vs. 43%; P = .03), but were no longer significant at week 8 (26.5% vs. 34.2%), she said.

A subgroup analysis of female patients showed significant improvements in moderate to severe global dyspeptic symptoms with rifaximin compared with placebo at week 4 (20.8% vs. 59.4%; P = .006) and week 8 (20% vs. 48.4%; P = .048).

Treatment response was not reflected in change in hydrogen breath response, Dr. Tan said. Results of a 3-hour hydrogen breath test performed after a 12-hour overnight fast showed no differences between the rifaximin and placebo groups for H₂ peak above baseline (2.94 ppm vs. 0.11 ppm; P = .29), H₂ area under the curve (+43.64 ppm vs. –49.71 ppm; P = .76), and oro-cecal transit time (24.23 minutes vs. 16.5 minutes; P = .68).

Adverse events were very similar between the two groups at both 4 and 8 weeks, Dr. Tan said. Only one major event occurred, a severe case of acute hepatitis in a woman in the placebo arm who also took traditional Chinese herbs.

pwendling@frontlinemedcom.com

On Twitter @pwendl

Pivotal new high-quality evidence from randomized clinical trials and other sources published since 2013 has prompted the American Heart Association and the American Stroke Association to update their joint clinical practice guideline on endovascular treatment of acute ischemic stroke.

The revisions were published online June 29 in Stroke.

Unchanged is the key recommendation that intravenous recombinant tissue-type plasminogen activator (r-tPA) remain the mainstay of initial therapy, even if endovascular treatment is being considered. But a new recommendation adds that a period of observation to assess patients’ clinical response to r-tPA before proceeding with endovascular therapy is not necessary and is not advisable, said Dr. William J. Powers, chair of the guideline writing committee and professor and chairman of the department of neurology, University of North Carolina, Durham, and his associates.

Courtesy American Heart Association

Most of the updates pertain to the use of a stent retriever, which is now recommended for all patients with acute ischemic stroke who meet these seven criteria:

1. A prestroke modified Rankin scale (mRS) score of 0-1.

2. Receipt of r-tPA within 4.5 hours of symptom onset.

3. Causative occlusion of the internal carotid artery or proximal middle cerebral artery.

4. Age of 18 years or older.

5. A National Institutes of Health Stroke Scale (NIHSS) score of 6 or greater.

6. An Alberta Stroke Program Early CT Score (ASPECTS) of 6 or greater.

7. Initiation of the procedure within 6 hours of symptom onset.

Use of stent retrievers also is now considered “reasonable” in carefully selected patients with occlusion of the anterior circulation who have contraindications to r-tPA, such as current use of anticoagulants, prior stroke, serious head trauma, or hemorrhagic coagulopathy. It also may be reasonable in selected patients who have causative occlusion of the M2 or M3 portion of the middle cerebral arteries, anterior cerebral arteries, vertebral arteries, basilar artery, or posterior cerebral arteries, although the benefits are “uncertain” in this patient population.

Similarly, endovascular therapy using stent retrievers may be reasonable for some patients younger than age 18 who otherwise meet the seven criteria, even though the benefits of treatment haven’t been established in this age group. And it likewise may be reasonable in patients with prestroke mRS scores greater than 1, an ASPECTS of less than 6, or NIHSS scores of less than 6 if there is causative occlusion of the internal carotid artery or the proximal middle cerebral artery.

The updated guideline also says that stent retrievers are preferable to the Merci device, but that other mechanical thrombectomy devices may be reasonable to use in some circumstances. And adjunctive use of a proximal balloon guide catheter or a large-bore distal access catheter rather than a cervical guide catheter along with stent retrievers also may be beneficial.

In addition, “the technical goal of the thrombectomy procedure should be a TICI [Thrombolysis in Cerebral Infarction] 2b/3 angiographic result to maximize the probability of a good functional outcome. Use of salvage technical adjuncts including intra-arterial fibrinolysis may be reasonable to achieve these angiographic results, if completed within 6 hours of symptom onset,” the guideline states (Stroke 2015 June 29 [doi:10.1161/STR.0000000000000074]).

Also with regard to intra-arterial rather than intravenous fibrinolysis, stent retrievers are now preferable to intra-arterial fibrinolysis as first-line therapy.

The updated guideline also has added the recommendation that conscious sedation may be preferable to general anesthesia during endovascular therapy, depending on patient risk factors, tolerance of the procedure, and other clinical characteristics. It also revised recommendations addressing imaging studies and systems of stroke care.

Five prospective, randomized controlled trials have come out in the past few months, and triggered a revolution in acute stroke therapy. All five studies – MR CLEAN, ESCAPE, EXTENT IA, SWIFT PRIME, and REVASCAT – were halted early because of the significant advantage mechanical endovascular therapy with stents or thrombus retrieval devices demonstrated over standard therapy featuring clot thrombolysis with r-tPA.

Collectively, the five trials showed a 60% greater chance for good functional recovery from stroke with endovascular interventions. The rate of a favorable neurologic outcome as reflected in a modified Rankin score of 0-2 was 48% with the use of stent/retriever devices, compared with 30% with thrombolysis alone, said Dr. Petr Widimsky, professor and chair of the cardiology department at Charles University in Prague, at the annual congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) held in Paris in May.

The American Academy of Neurology “affirms the value of this guideline as an educational tool for neurologists.” The revised guideline is endorsed by the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, the American Society of Neuroradiology, and the Society of Vascular and Interventional Neurology. A copy of the document is available at http://myamericanheart.org/statements.

Pivotal new high-quality evidence from randomized clinical trials and other sources published since 2013 has prompted the American Heart Association and the American Stroke Association to update their joint clinical practice guideline on endovascular treatment of acute ischemic stroke.

The revisions were published online June 29 in Stroke.

Unchanged is the key recommendation that intravenous recombinant tissue-type plasminogen activator (r-tPA) remain the mainstay of initial therapy, even if endovascular treatment is being considered. But a new recommendation adds that a period of observation to assess patients’ clinical response to r-tPA before proceeding with endovascular therapy is not necessary and is not advisable, said Dr. William J. Powers, chair of the guideline writing committee and professor and chairman of the department of neurology, University of North Carolina, Durham, and his associates.

Courtesy American Heart Association

Most of the updates pertain to the use of a stent retriever, which is now recommended for all patients with acute ischemic stroke who meet these seven criteria:

1. A prestroke modified Rankin scale (mRS) score of 0-1.

2. Receipt of r-tPA within 4.5 hours of symptom onset.

3. Causative occlusion of the internal carotid artery or proximal middle cerebral artery.

4. Age of 18 years or older.

5. A National Institutes of Health Stroke Scale (NIHSS) score of 6 or greater.

6. An Alberta Stroke Program Early CT Score (ASPECTS) of 6 or greater.

7. Initiation of the procedure within 6 hours of symptom onset.

Use of stent retrievers also is now considered “reasonable” in carefully selected patients with occlusion of the anterior circulation who have contraindications to r-tPA, such as current use of anticoagulants, prior stroke, serious head trauma, or hemorrhagic coagulopathy. It also may be reasonable in selected patients who have causative occlusion of the M2 or M3 portion of the middle cerebral arteries, anterior cerebral arteries, vertebral arteries, basilar artery, or posterior cerebral arteries, although the benefits are “uncertain” in this patient population.

Similarly, endovascular therapy using stent retrievers may be reasonable for some patients younger than age 18 who otherwise meet the seven criteria, even though the benefits of treatment haven’t been established in this age group. And it likewise may be reasonable in patients with prestroke mRS scores greater than 1, an ASPECTS of less than 6, or NIHSS scores of less than 6 if there is causative occlusion of the internal carotid artery or the proximal middle cerebral artery.

The updated guideline also says that stent retrievers are preferable to the Merci device, but that other mechanical thrombectomy devices may be reasonable to use in some circumstances. And adjunctive use of a proximal balloon guide catheter or a large-bore distal access catheter rather than a cervical guide catheter along with stent retrievers also may be beneficial.

In addition, “the technical goal of the thrombectomy procedure should be a TICI [Thrombolysis in Cerebral Infarction] 2b/3 angiographic result to maximize the probability of a good functional outcome. Use of salvage technical adjuncts including intra-arterial fibrinolysis may be reasonable to achieve these angiographic results, if completed within 6 hours of symptom onset,” the guideline states (Stroke 2015 June 29 [doi:10.1161/STR.0000000000000074]).

Also with regard to intra-arterial rather than intravenous fibrinolysis, stent retrievers are now preferable to intra-arterial fibrinolysis as first-line therapy.

The updated guideline also has added the recommendation that conscious sedation may be preferable to general anesthesia during endovascular therapy, depending on patient risk factors, tolerance of the procedure, and other clinical characteristics. It also revised recommendations addressing imaging studies and systems of stroke care.

Five prospective, randomized controlled trials have come out in the past few months, and triggered a revolution in acute stroke therapy. All five studies – MR CLEAN, ESCAPE, EXTENT IA, SWIFT PRIME, and REVASCAT – were halted early because of the significant advantage mechanical endovascular therapy with stents or thrombus retrieval devices demonstrated over standard therapy featuring clot thrombolysis with r-tPA.

Collectively, the five trials showed a 60% greater chance for good functional recovery from stroke with endovascular interventions. The rate of a favorable neurologic outcome as reflected in a modified Rankin score of 0-2 was 48% with the use of stent/retriever devices, compared with 30% with thrombolysis alone, said Dr. Petr Widimsky, professor and chair of the cardiology department at Charles University in Prague, at the annual congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) held in Paris in May.

The American Academy of Neurology “affirms the value of this guideline as an educational tool for neurologists.” The revised guideline is endorsed by the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, the American Society of Neuroradiology, and the Society of Vascular and Interventional Neurology. A copy of the document is available at http://myamericanheart.org/statements.

Pivotal new high-quality evidence from randomized clinical trials and other sources published since 2013 has prompted the American Heart Association and the American Stroke Association to update their joint clinical practice guideline on endovascular treatment of acute ischemic stroke.

The revisions were published online June 29 in Stroke.

Unchanged is the key recommendation that intravenous recombinant tissue-type plasminogen activator (r-tPA) remain the mainstay of initial therapy, even if endovascular treatment is being considered. But a new recommendation adds that a period of observation to assess patients’ clinical response to r-tPA before proceeding with endovascular therapy is not necessary and is not advisable, said Dr. William J. Powers, chair of the guideline writing committee and professor and chairman of the department of neurology, University of North Carolina, Durham, and his associates.

Courtesy American Heart Association

Most of the updates pertain to the use of a stent retriever, which is now recommended for all patients with acute ischemic stroke who meet these seven criteria:

1. A prestroke modified Rankin scale (mRS) score of 0-1.

2. Receipt of r-tPA within 4.5 hours of symptom onset.

3. Causative occlusion of the internal carotid artery or proximal middle cerebral artery.

4. Age of 18 years or older.

5. A National Institutes of Health Stroke Scale (NIHSS) score of 6 or greater.

6. An Alberta Stroke Program Early CT Score (ASPECTS) of 6 or greater.

7. Initiation of the procedure within 6 hours of symptom onset.

Use of stent retrievers also is now considered “reasonable” in carefully selected patients with occlusion of the anterior circulation who have contraindications to r-tPA, such as current use of anticoagulants, prior stroke, serious head trauma, or hemorrhagic coagulopathy. It also may be reasonable in selected patients who have causative occlusion of the M2 or M3 portion of the middle cerebral arteries, anterior cerebral arteries, vertebral arteries, basilar artery, or posterior cerebral arteries, although the benefits are “uncertain” in this patient population.

Similarly, endovascular therapy using stent retrievers may be reasonable for some patients younger than age 18 who otherwise meet the seven criteria, even though the benefits of treatment haven’t been established in this age group. And it likewise may be reasonable in patients with prestroke mRS scores greater than 1, an ASPECTS of less than 6, or NIHSS scores of less than 6 if there is causative occlusion of the internal carotid artery or the proximal middle cerebral artery.

The updated guideline also says that stent retrievers are preferable to the Merci device, but that other mechanical thrombectomy devices may be reasonable to use in some circumstances. And adjunctive use of a proximal balloon guide catheter or a large-bore distal access catheter rather than a cervical guide catheter along with stent retrievers also may be beneficial.

In addition, “the technical goal of the thrombectomy procedure should be a TICI [Thrombolysis in Cerebral Infarction] 2b/3 angiographic result to maximize the probability of a good functional outcome. Use of salvage technical adjuncts including intra-arterial fibrinolysis may be reasonable to achieve these angiographic results, if completed within 6 hours of symptom onset,” the guideline states (Stroke 2015 June 29 [doi:10.1161/STR.0000000000000074]).

Also with regard to intra-arterial rather than intravenous fibrinolysis, stent retrievers are now preferable to intra-arterial fibrinolysis as first-line therapy.

The updated guideline also has added the recommendation that conscious sedation may be preferable to general anesthesia during endovascular therapy, depending on patient risk factors, tolerance of the procedure, and other clinical characteristics. It also revised recommendations addressing imaging studies and systems of stroke care.

Five prospective, randomized controlled trials have come out in the past few months, and triggered a revolution in acute stroke therapy. All five studies – MR CLEAN, ESCAPE, EXTENT IA, SWIFT PRIME, and REVASCAT – were halted early because of the significant advantage mechanical endovascular therapy with stents or thrombus retrieval devices demonstrated over standard therapy featuring clot thrombolysis with r-tPA.

Collectively, the five trials showed a 60% greater chance for good functional recovery from stroke with endovascular interventions. The rate of a favorable neurologic outcome as reflected in a modified Rankin score of 0-2 was 48% with the use of stent/retriever devices, compared with 30% with thrombolysis alone, said Dr. Petr Widimsky, professor and chair of the cardiology department at Charles University in Prague, at the annual congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) held in Paris in May.

The American Academy of Neurology “affirms the value of this guideline as an educational tool for neurologists.” The revised guideline is endorsed by the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, the American Society of Neuroradiology, and the Society of Vascular and Interventional Neurology. A copy of the document is available at http://myamericanheart.org/statements.

CHICAGO – Four preoperative variables predict whether or not patients will survive ruptured abdominal aortic aneurysm repairs, according to investigators from Harborview Medical Center in Seattle.

It’s an important finding because until now, it’s been hard to know how they’ll do. Previous risk scores also rely on intraoperative variables, or haven’t been validated for endovascular repair.

Investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, explained in a video interview what the four variables are at a meeting hosted by the Society for Vascular Surgery, and why it was so important for a level 1 trauma center like Harborview to identify them.

aotto@frontlinemedcom.com

CHICAGO – Four preoperative variables predict whether or not patients will survive ruptured abdominal aortic aneurysm repairs, according to investigators from Harborview Medical Center in Seattle.

It’s an important finding because until now, it’s been hard to know how they’ll do. Previous risk scores also rely on intraoperative variables, or haven’t been validated for endovascular repair.

Investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, explained in a video interview what the four variables are at a meeting hosted by the Society for Vascular Surgery, and why it was so important for a level 1 trauma center like Harborview to identify them.

aotto@frontlinemedcom.com

CHICAGO – Four preoperative variables predict whether or not patients will survive ruptured abdominal aortic aneurysm repairs, according to investigators from Harborview Medical Center in Seattle.

It’s an important finding because until now, it’s been hard to know how they’ll do. Previous risk scores also rely on intraoperative variables, or haven’t been validated for endovascular repair.

Investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, explained in a video interview what the four variables are at a meeting hosted by the Society for Vascular Surgery, and why it was so important for a level 1 trauma center like Harborview to identify them.

aotto@frontlinemedcom.com

WASHINGTON – An experimental acid suppressant was effective for prevention of peptic ulcer recurrence during NSAID therapy, with a safety profile similar to that of a currently marketed proton pump inhibitor, investigators reported.

At 2 years of follow-up, rates of recurrent peptic ulcers or hemorrhagic lesions in the stomach or duodenum among patients who took vonoprazan (marketed in Japan as Takecab) at a 10-mg or 20-mg daily oral dose were numerically but not statistically significantly lower than those for patients who took a 15-mg once daily dose of lansoprazole (Prevacid), said Dr. Yuji Mizokami of University of Tsukuba Hospital in Ibaraki, Japan.

“The long-term safety profile of vonoprazan was similar to lansoprazole, and no safety issues were identified,” he said at the annual Digestive Disease Week.

Proton pump inhibitors (PPIs) such as lansoprazole are frequently prescribed as concomitant gastroprotective agents in patients on long-term therapy with a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen.

PIs have relatively short half-lives, however, which may limit their effectiveness as gastroprotectives. In addition, polymorphisms in the gene encoding for cytochrome P2C19 (CYP2C19) can affect PPI metabolism, Dr. Mizokami said.

Vonoprazan belongs to a new class of acid-suppressing drugs called potassium-competitive acid blockers (PCABs), which, unlike PPIs, do not need to be activated by acid to become effective and are not affected by genetic variations. Vonoprazan migrates from blood into the secretory canaliculus of acid-secreting parietal cells, and because of its longer elimination half-life and stability in acidic environments, provides a strong acid-inhibiting effect from the first dose, and remains effective for 24 hours, Dr. Mizokami explained.

He presented data from a 2-year extension of a phase III, 24-week noninferiority study comparing vonoprazan with lansoprazole for prevention of peptic ulcer recurrence. In that study, 5.5% of patients on lansoprazole had recurrent gastric or duodenal ulcers by week 24, compared with 3.3% of patients on 10 mg vonoprazan, and 3.4% of those on 20 mg vonoprazan.

A total of 357 patients completed the extension study: 108 initially assigned to lansoprazole, 131 to vonoprazan 10 mg, and 118 to vonoprazan 20 mg.

At 1 year, the rates of recurrent ulcers were 7% for patients on lansoprazole, 3.6% for those on vonoprazan 10 mg, and 5.4% for those on vonoprazan 20 mg. The respective rates at 2 years were 7.5%. 3.8%, and 5.9%. In a safety analysis (intention-to-treat), treatment-emergent adverse events were mild, did not appear to be dose dependent with vonoprazan, and did not increase over time.

Serious treatment-emergent events occurred in 8.6% among the patients on lansoprazole, 8.3% among patients on 10 mg vonoprazan, and 14.2% among those on 20 mg. Events leading to drug discontinuation occurred in 7.6%, 4.1%, and 12.2% of patients, respectively.

In all three study arms, but especially in the vonoprazan arms, there was an increase in serum gastrin seen at week 4, which increased moderately until week 52. After that, it began to decline among patients on vonoprazan, while plateauing among patients on lansoprazole.

There were also increases in pepsinogen I and II at week 4 in all three treatment groups; the levels remained stable thereafter, as did the ratio of pepsinogen I to pepsinogen II.

Vonoprazan is currently approved only in Japan. The manufacturer, Takeda, has not said if or when it intends to file for a New Drug Application in the United States. The study was supported by Takeda Pharmaceuticals. Dr. Mizokami disclosed serving as a consultant on the study. Four of the coauthors are company employees.

WASHINGTON – An experimental acid suppressant was effective for prevention of peptic ulcer recurrence during NSAID therapy, with a safety profile similar to that of a currently marketed proton pump inhibitor, investigators reported.

At 2 years of follow-up, rates of recurrent peptic ulcers or hemorrhagic lesions in the stomach or duodenum among patients who took vonoprazan (marketed in Japan as Takecab) at a 10-mg or 20-mg daily oral dose were numerically but not statistically significantly lower than those for patients who took a 15-mg once daily dose of lansoprazole (Prevacid), said Dr. Yuji Mizokami of University of Tsukuba Hospital in Ibaraki, Japan.

“The long-term safety profile of vonoprazan was similar to lansoprazole, and no safety issues were identified,” he said at the annual Digestive Disease Week.

Proton pump inhibitors (PPIs) such as lansoprazole are frequently prescribed as concomitant gastroprotective agents in patients on long-term therapy with a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen.

PIs have relatively short half-lives, however, which may limit their effectiveness as gastroprotectives. In addition, polymorphisms in the gene encoding for cytochrome P2C19 (CYP2C19) can affect PPI metabolism, Dr. Mizokami said.

Vonoprazan belongs to a new class of acid-suppressing drugs called potassium-competitive acid blockers (PCABs), which, unlike PPIs, do not need to be activated by acid to become effective and are not affected by genetic variations. Vonoprazan migrates from blood into the secretory canaliculus of acid-secreting parietal cells, and because of its longer elimination half-life and stability in acidic environments, provides a strong acid-inhibiting effect from the first dose, and remains effective for 24 hours, Dr. Mizokami explained.

He presented data from a 2-year extension of a phase III, 24-week noninferiority study comparing vonoprazan with lansoprazole for prevention of peptic ulcer recurrence. In that study, 5.5% of patients on lansoprazole had recurrent gastric or duodenal ulcers by week 24, compared with 3.3% of patients on 10 mg vonoprazan, and 3.4% of those on 20 mg vonoprazan.

A total of 357 patients completed the extension study: 108 initially assigned to lansoprazole, 131 to vonoprazan 10 mg, and 118 to vonoprazan 20 mg.

At 1 year, the rates of recurrent ulcers were 7% for patients on lansoprazole, 3.6% for those on vonoprazan 10 mg, and 5.4% for those on vonoprazan 20 mg. The respective rates at 2 years were 7.5%. 3.8%, and 5.9%. In a safety analysis (intention-to-treat), treatment-emergent adverse events were mild, did not appear to be dose dependent with vonoprazan, and did not increase over time.

Serious treatment-emergent events occurred in 8.6% among the patients on lansoprazole, 8.3% among patients on 10 mg vonoprazan, and 14.2% among those on 20 mg. Events leading to drug discontinuation occurred in 7.6%, 4.1%, and 12.2% of patients, respectively.

In all three study arms, but especially in the vonoprazan arms, there was an increase in serum gastrin seen at week 4, which increased moderately until week 52. After that, it began to decline among patients on vonoprazan, while plateauing among patients on lansoprazole.

There were also increases in pepsinogen I and II at week 4 in all three treatment groups; the levels remained stable thereafter, as did the ratio of pepsinogen I to pepsinogen II.

Vonoprazan is currently approved only in Japan. The manufacturer, Takeda, has not said if or when it intends to file for a New Drug Application in the United States. The study was supported by Takeda Pharmaceuticals. Dr. Mizokami disclosed serving as a consultant on the study. Four of the coauthors are company employees.

WASHINGTON – An experimental acid suppressant was effective for prevention of peptic ulcer recurrence during NSAID therapy, with a safety profile similar to that of a currently marketed proton pump inhibitor, investigators reported.

At 2 years of follow-up, rates of recurrent peptic ulcers or hemorrhagic lesions in the stomach or duodenum among patients who took vonoprazan (marketed in Japan as Takecab) at a 10-mg or 20-mg daily oral dose were numerically but not statistically significantly lower than those for patients who took a 15-mg once daily dose of lansoprazole (Prevacid), said Dr. Yuji Mizokami of University of Tsukuba Hospital in Ibaraki, Japan.

“The long-term safety profile of vonoprazan was similar to lansoprazole, and no safety issues were identified,” he said at the annual Digestive Disease Week.

Proton pump inhibitors (PPIs) such as lansoprazole are frequently prescribed as concomitant gastroprotective agents in patients on long-term therapy with a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen.

PIs have relatively short half-lives, however, which may limit their effectiveness as gastroprotectives. In addition, polymorphisms in the gene encoding for cytochrome P2C19 (CYP2C19) can affect PPI metabolism, Dr. Mizokami said.

Vonoprazan belongs to a new class of acid-suppressing drugs called potassium-competitive acid blockers (PCABs), which, unlike PPIs, do not need to be activated by acid to become effective and are not affected by genetic variations. Vonoprazan migrates from blood into the secretory canaliculus of acid-secreting parietal cells, and because of its longer elimination half-life and stability in acidic environments, provides a strong acid-inhibiting effect from the first dose, and remains effective for 24 hours, Dr. Mizokami explained.

He presented data from a 2-year extension of a phase III, 24-week noninferiority study comparing vonoprazan with lansoprazole for prevention of peptic ulcer recurrence. In that study, 5.5% of patients on lansoprazole had recurrent gastric or duodenal ulcers by week 24, compared with 3.3% of patients on 10 mg vonoprazan, and 3.4% of those on 20 mg vonoprazan.

A total of 357 patients completed the extension study: 108 initially assigned to lansoprazole, 131 to vonoprazan 10 mg, and 118 to vonoprazan 20 mg.

At 1 year, the rates of recurrent ulcers were 7% for patients on lansoprazole, 3.6% for those on vonoprazan 10 mg, and 5.4% for those on vonoprazan 20 mg. The respective rates at 2 years were 7.5%. 3.8%, and 5.9%. In a safety analysis (intention-to-treat), treatment-emergent adverse events were mild, did not appear to be dose dependent with vonoprazan, and did not increase over time.

Serious treatment-emergent events occurred in 8.6% among the patients on lansoprazole, 8.3% among patients on 10 mg vonoprazan, and 14.2% among those on 20 mg. Events leading to drug discontinuation occurred in 7.6%, 4.1%, and 12.2% of patients, respectively.

In all three study arms, but especially in the vonoprazan arms, there was an increase in serum gastrin seen at week 4, which increased moderately until week 52. After that, it began to decline among patients on vonoprazan, while plateauing among patients on lansoprazole.

There were also increases in pepsinogen I and II at week 4 in all three treatment groups; the levels remained stable thereafter, as did the ratio of pepsinogen I to pepsinogen II.

Vonoprazan is currently approved only in Japan. The manufacturer, Takeda, has not said if or when it intends to file for a New Drug Application in the United States. The study was supported by Takeda Pharmaceuticals. Dr. Mizokami disclosed serving as a consultant on the study. Four of the coauthors are company employees.

WASHINGTON – Early resumption of antiplatelet agents or anticoagulants after a major gastrointestinal bleeding event is clearly associated with an increased risk of rebleeding, but a decreased risk of death, results from an observational study show.

Furthermore, anticoagulant treatment “is associated with a higher risk of rebleeding and death compared with antiplatelet treatment after a previous GI event,” Dr. Angel Lanas said to an overflow crowd at the annual Digestive Disease Week.

Patrice Wendling/Frontline Medical News

In a separate case-control study, Dr. Lanas and his associates recently reported that the risk of GI bleeding was twofold higher for anticoagulants than for low-dose aspirin in patients hospitalized for GI bleeding (Clin. Gastroenterol. Hepatol. 2015 May;13:906-12.e2. [doi:10.1016/j.cgh.2014.11.007])

The current study examined adverse events in a cohort of 160 patients who developed a major gastrointestinal bleed (GIB) while using anticoagulants and/or antiplatelet therapy between March 2008 and July 2013. Long-term interruption or short-term resumption of these treatments has important clinical implications and differences in the intrinsic risks between antiplatelet or anticoagulant users after drug resumption are not well established, said Dr. Lanas of the University of Zaragoza (Spain).

Patrice Wendling/Frontline Medical News

Drug use information was prospectively collected during the GIB event, with data during the follow-up period obtained from two different Spanish databases.

Treatment during the index bleeding event was continued without interruption in 11 patients and interrupted in 149 patients (93%). Among those whose therapy was interrupted, 21 (14%) never resumed therapy and 128 (86%) resumed therapy (118 patients within 15 days and 10 patients after 15 days). The 86% treatment resumption rate is much higher than the 40%-66% rates reported in previous studies, indicating that Spanish physicians restarted treatment quite early, Dr. Lanas observed.

The mean age at baseline was 76.6 years, 61.3% of patients were men, and half had a Charlson index score > 4. Median follow-up was 21.5 months (range 1-63 months).

Ischemic events did not differ between patients who did or did not restart anticoagulants or antiplatelets (16.4% vs. 14.3%; P value = .806). However, rebleeding occurred in 32% of patients who resumed therapy versus none who did not (P = .002), but deaths were higher in those who did not restart therapy (38.1% vs. 12.5%; P = .003), Dr. Lanas said.

These differences remain significant in Kaplan-Meier survival curves for death (P = .021) and rebleeding (P = .004).

A comparison of early therapy resumption (≤ 15 days) vs. delayed (mean delay 62 days) or no resumption revealed similar results. Early resumption was associated with a higher rate of rebleeding (32.2% vs. 9.7%; P = .012), but a lower rate of death (11% vs. 35.5%; P = .001), with no difference in ischemic events (17% vs. 13%; P = .586), Dr. Lanas said.

Again, the differences remain significant in Kaplan-Meier survival curves for death (P = .011) and rebleeding (P = .013).

When the investigators looked at rebleeding according to drug use, patients receiving anticoagulants vs. antiplatelets had significantly higher rates of rebleeding (34.7% vs. 20.5%; P = .043), death (22.2% vs. 10.2%; P = .038), and any event (68.1% vs. 52.3%; P = .043).

After adjustment for gender, age, Charlson index, diabetes, and arterial hypertension, the risk of rebleeding was more than threefold higher for dual antiplatelet and anticoagulant users than for antiplatelet-alone users (odds ratio, 3.45; P = .025) and was twofold higher for anticoagulant vs. antiplatelet users (OR, 2.07; P = .045), Dr. Lanas said.

Finally, an analysis of the cause of bleeding suggests the cause of rebleeding may be different from the original event and that there is a shift toward the lower GI tract, he added.

The index bleeding event was caused largely by an upper GI peptic ulcer in 48% of all 160 patients, with 43.7% of events due to lower GI diverticulosis, vascular lesions, ischemic, or other lesions. In contrast, peptic ulcers accounted for only 7% of rebleeding events, while lower GI events accounted for 72%. Proton pump inhibition use was evenly distributed in upper and lower GI bleeding, although effective endoscopic treatment may have influenced upper GI bleeds, Dr. Lanas said.

“The importance of this is that we may have very good therapy tools for the upper GI, but still we have problems controlling the bleeding from the lower GI,” he added.

During a discussion of the study, an audience member asked how many days clinicians should wait to restart anticoagulants or antiplatelets.

“In those patients with peptic ulcer bleeding, it’s better to just give the antiplatelet therapy soon after the bleeding event or just to not interrupt the aspirin because the morality at 30 days was higher in those who were interrupted,” Dr. Lanas advised. “...I think for the cutoff point to show differences for patients with a worse outcome versus those with a better outcome, you shouldn’t restart anticoagulant therapy before day 15 after the bleeding event.”

Dr. Lanas received consulting fees, speaking and teaching fees, other financial support, and grant and research support from Bayer.

pwendling@frontlinemedcom.com

On Twitter @pwendl

WASHINGTON – Early resumption of antiplatelet agents or anticoagulants after a major gastrointestinal bleeding event is clearly associated with an increased risk of rebleeding, but a decreased risk of death, results from an observational study show.

Furthermore, anticoagulant treatment “is associated with a higher risk of rebleeding and death compared with antiplatelet treatment after a previous GI event,” Dr. Angel Lanas said to an overflow crowd at the annual Digestive Disease Week.

Patrice Wendling/Frontline Medical News

In a separate case-control study, Dr. Lanas and his associates recently reported that the risk of GI bleeding was twofold higher for anticoagulants than for low-dose aspirin in patients hospitalized for GI bleeding (Clin. Gastroenterol. Hepatol. 2015 May;13:906-12.e2. [doi:10.1016/j.cgh.2014.11.007])

The current study examined adverse events in a cohort of 160 patients who developed a major gastrointestinal bleed (GIB) while using anticoagulants and/or antiplatelet therapy between March 2008 and July 2013. Long-term interruption or short-term resumption of these treatments has important clinical implications and differences in the intrinsic risks between antiplatelet or anticoagulant users after drug resumption are not well established, said Dr. Lanas of the University of Zaragoza (Spain).

Patrice Wendling/Frontline Medical News

Drug use information was prospectively collected during the GIB event, with data during the follow-up period obtained from two different Spanish databases.

Treatment during the index bleeding event was continued without interruption in 11 patients and interrupted in 149 patients (93%). Among those whose therapy was interrupted, 21 (14%) never resumed therapy and 128 (86%) resumed therapy (118 patients within 15 days and 10 patients after 15 days). The 86% treatment resumption rate is much higher than the 40%-66% rates reported in previous studies, indicating that Spanish physicians restarted treatment quite early, Dr. Lanas observed.

The mean age at baseline was 76.6 years, 61.3% of patients were men, and half had a Charlson index score > 4. Median follow-up was 21.5 months (range 1-63 months).

Ischemic events did not differ between patients who did or did not restart anticoagulants or antiplatelets (16.4% vs. 14.3%; P value = .806). However, rebleeding occurred in 32% of patients who resumed therapy versus none who did not (P = .002), but deaths were higher in those who did not restart therapy (38.1% vs. 12.5%; P = .003), Dr. Lanas said.

These differences remain significant in Kaplan-Meier survival curves for death (P = .021) and rebleeding (P = .004).

A comparison of early therapy resumption (≤ 15 days) vs. delayed (mean delay 62 days) or no resumption revealed similar results. Early resumption was associated with a higher rate of rebleeding (32.2% vs. 9.7%; P = .012), but a lower rate of death (11% vs. 35.5%; P = .001), with no difference in ischemic events (17% vs. 13%; P = .586), Dr. Lanas said.

Again, the differences remain significant in Kaplan-Meier survival curves for death (P = .011) and rebleeding (P = .013).

When the investigators looked at rebleeding according to drug use, patients receiving anticoagulants vs. antiplatelets had significantly higher rates of rebleeding (34.7% vs. 20.5%; P = .043), death (22.2% vs. 10.2%; P = .038), and any event (68.1% vs. 52.3%; P = .043).

After adjustment for gender, age, Charlson index, diabetes, and arterial hypertension, the risk of rebleeding was more than threefold higher for dual antiplatelet and anticoagulant users than for antiplatelet-alone users (odds ratio, 3.45; P = .025) and was twofold higher for anticoagulant vs. antiplatelet users (OR, 2.07; P = .045), Dr. Lanas said.

Finally, an analysis of the cause of bleeding suggests the cause of rebleeding may be different from the original event and that there is a shift toward the lower GI tract, he added.

The index bleeding event was caused largely by an upper GI peptic ulcer in 48% of all 160 patients, with 43.7% of events due to lower GI diverticulosis, vascular lesions, ischemic, or other lesions. In contrast, peptic ulcers accounted for only 7% of rebleeding events, while lower GI events accounted for 72%. Proton pump inhibition use was evenly distributed in upper and lower GI bleeding, although effective endoscopic treatment may have influenced upper GI bleeds, Dr. Lanas said.

“The importance of this is that we may have very good therapy tools for the upper GI, but still we have problems controlling the bleeding from the lower GI,” he added.

During a discussion of the study, an audience member asked how many days clinicians should wait to restart anticoagulants or antiplatelets.

“In those patients with peptic ulcer bleeding, it’s better to just give the antiplatelet therapy soon after the bleeding event or just to not interrupt the aspirin because the morality at 30 days was higher in those who were interrupted,” Dr. Lanas advised. “...I think for the cutoff point to show differences for patients with a worse outcome versus those with a better outcome, you shouldn’t restart anticoagulant therapy before day 15 after the bleeding event.”

Dr. Lanas received consulting fees, speaking and teaching fees, other financial support, and grant and research support from Bayer.

pwendling@frontlinemedcom.com

On Twitter @pwendl

WASHINGTON – Early resumption of antiplatelet agents or anticoagulants after a major gastrointestinal bleeding event is clearly associated with an increased risk of rebleeding, but a decreased risk of death, results from an observational study show.

Furthermore, anticoagulant treatment “is associated with a higher risk of rebleeding and death compared with antiplatelet treatment after a previous GI event,” Dr. Angel Lanas said to an overflow crowd at the annual Digestive Disease Week.

Patrice Wendling/Frontline Medical News

In a separate case-control study, Dr. Lanas and his associates recently reported that the risk of GI bleeding was twofold higher for anticoagulants than for low-dose aspirin in patients hospitalized for GI bleeding (Clin. Gastroenterol. Hepatol. 2015 May;13:906-12.e2. [doi:10.1016/j.cgh.2014.11.007])

The current study examined adverse events in a cohort of 160 patients who developed a major gastrointestinal bleed (GIB) while using anticoagulants and/or antiplatelet therapy between March 2008 and July 2013. Long-term interruption or short-term resumption of these treatments has important clinical implications and differences in the intrinsic risks between antiplatelet or anticoagulant users after drug resumption are not well established, said Dr. Lanas of the University of Zaragoza (Spain).

Patrice Wendling/Frontline Medical News

Drug use information was prospectively collected during the GIB event, with data during the follow-up period obtained from two different Spanish databases.

Treatment during the index bleeding event was continued without interruption in 11 patients and interrupted in 149 patients (93%). Among those whose therapy was interrupted, 21 (14%) never resumed therapy and 128 (86%) resumed therapy (118 patients within 15 days and 10 patients after 15 days). The 86% treatment resumption rate is much higher than the 40%-66% rates reported in previous studies, indicating that Spanish physicians restarted treatment quite early, Dr. Lanas observed.

The mean age at baseline was 76.6 years, 61.3% of patients were men, and half had a Charlson index score > 4. Median follow-up was 21.5 months (range 1-63 months).

Ischemic events did not differ between patients who did or did not restart anticoagulants or antiplatelets (16.4% vs. 14.3%; P value = .806). However, rebleeding occurred in 32% of patients who resumed therapy versus none who did not (P = .002), but deaths were higher in those who did not restart therapy (38.1% vs. 12.5%; P = .003), Dr. Lanas said.

These differences remain significant in Kaplan-Meier survival curves for death (P = .021) and rebleeding (P = .004).

A comparison of early therapy resumption (≤ 15 days) vs. delayed (mean delay 62 days) or no resumption revealed similar results. Early resumption was associated with a higher rate of rebleeding (32.2% vs. 9.7%; P = .012), but a lower rate of death (11% vs. 35.5%; P = .001), with no difference in ischemic events (17% vs. 13%; P = .586), Dr. Lanas said.

Again, the differences remain significant in Kaplan-Meier survival curves for death (P = .011) and rebleeding (P = .013).

When the investigators looked at rebleeding according to drug use, patients receiving anticoagulants vs. antiplatelets had significantly higher rates of rebleeding (34.7% vs. 20.5%; P = .043), death (22.2% vs. 10.2%; P = .038), and any event (68.1% vs. 52.3%; P = .043).

After adjustment for gender, age, Charlson index, diabetes, and arterial hypertension, the risk of rebleeding was more than threefold higher for dual antiplatelet and anticoagulant users than for antiplatelet-alone users (odds ratio, 3.45; P = .025) and was twofold higher for anticoagulant vs. antiplatelet users (OR, 2.07; P = .045), Dr. Lanas said.

Finally, an analysis of the cause of bleeding suggests the cause of rebleeding may be different from the original event and that there is a shift toward the lower GI tract, he added.

The index bleeding event was caused largely by an upper GI peptic ulcer in 48% of all 160 patients, with 43.7% of events due to lower GI diverticulosis, vascular lesions, ischemic, or other lesions. In contrast, peptic ulcers accounted for only 7% of rebleeding events, while lower GI events accounted for 72%. Proton pump inhibition use was evenly distributed in upper and lower GI bleeding, although effective endoscopic treatment may have influenced upper GI bleeds, Dr. Lanas said.

“The importance of this is that we may have very good therapy tools for the upper GI, but still we have problems controlling the bleeding from the lower GI,” he added.

During a discussion of the study, an audience member asked how many days clinicians should wait to restart anticoagulants or antiplatelets.

“In those patients with peptic ulcer bleeding, it’s better to just give the antiplatelet therapy soon after the bleeding event or just to not interrupt the aspirin because the morality at 30 days was higher in those who were interrupted,” Dr. Lanas advised. “...I think for the cutoff point to show differences for patients with a worse outcome versus those with a better outcome, you shouldn’t restart anticoagulant therapy before day 15 after the bleeding event.”

Dr. Lanas received consulting fees, speaking and teaching fees, other financial support, and grant and research support from Bayer.

pwendling@frontlinemedcom.com

On Twitter @pwendl

WASHINGTON – Performed when recommended, cholecystecomy significantly decreases the risk of near-term rehospitalization for acute biliary pancreatitis, results of a retrospective study indicate.

Among more than 23,000 patients with mild to moderate acute biliary pancreatitis, less than 2% of those who underwent cholecystectomy within 30 days, as recommended under American Gastroenterological Association (AGA) guidelines, were rehospitalized for pancreatitis within 6 months.

In contrast, nearly 17% of patients who had cholecystectomy after 1 month or never had it were back in the hospital within half a year, said Dr. Ayesha Kamal, a postdoctoral research fellow at the Johns Hopkins Hospital in Baltimore.

“Cholecystectomy prevents future hospitalization for biliary pancreatitis,” she said at the annual Digestive Disease Week.

The study, based on claims data, also showed that adherence to AGA guidelines is fairly high, on the order of 75%, she said.

Acute pancreatitis is one of the most common gastrointestinal diseases in the United States, accounting for about 300,000 hospitalizations in 2009, at a total cost of about $2.6 billion.

Gallstone disease is the most common cause of acute pancreatitis, responsible for an estimated 40% of all cases, she said.

Guidelines from the AGA and other organizations recommend cholecystectomy either during the same hospitalization for acute biliary pancreatitis, or within 4 weeks.

To see whether clinicians were adhering to the AGA guidelines and whether the guideline-recommended timing of cholecystectomy made a difference, Dr. Kamal and colleagues analyzed data from the MarketScan Commercial Claims & Encounters database, which includes individual-level clinical utilization data for both inpatient and outpatient visits paid for by employer-sponsored health plans.

They looked at data both on patients who were treated in accordance with guidelines (first hospitalization for mild to moderate acute biliary pancreatitis, with cholecystectomy performed either on the day of hospitalization or within 30 days), and outside of the guidelines (no cholecystectomy, or cholecystectomy performed later than 30 days after the index hospitalization).

They assessed recurrences within 30 days of follow-up by International Classification of Diseases, 9th Revision (ICD-9) codes for acute pancreatitis and gallstone disease.

Combing through 8.8 million adult inpatient encounters for acute biliary pancreatitis, they excluded those patients with a diagnosis of severe or chronic pancreatitis, alcohol abuse, less than 30 days of follow-up, deaths during hospitalization, discharge to hospice, and those with a length of stay longer than 30 days.

This left them with a final cohort of 23,515 patients with mild to moderate acute biliary pancreatitis.

They found that 61% of patients had cholecystectomy during their initial hospitalizations, and an additional 14% had the surgery during a subsequent hospitalization within 30 days. Of the remaining patients, 7% had cholecystectomies after 30 days, and 18% never had one.

Among patients treated under the guidelines, 1.3% who had their gallbladders removed during the initial hospitalization had a pancreatitis recurrence within 6 months, and 0.2% had a recurrence more than 6 months later.

In contrast, 36.7% of patients who had a cholecystectomy more than a month after their first hospitalization for pancreatitis had a recurrence within 6 months, and 4.5% had a recurrence after 6 months.

Among patients who never underwent cholecystectomy, the respective recurrence rates were 5.4% and 1.1%.

“One in six patients who did not receive a cholecystectomy within 30 days will be hospitalized again within 6 months,” Dr. Kamal said.

She acknowledged that the study was limited by the authors’ inability to confirm acute biliary pancreatitis with chart review, and by the limitations of the database, which is confined to adults younger than 65 with employer-sponsored medical plans.

In the question and answer portion of the presentation, Dr. Nirav Thosani, a gastroenterologist at Memorial Hermann Hospital in Houston, noted that ICD-9 codes do not distinguish between different types of pancreatitis.

“It might be possible that those patients who never had cholecystectomy never had acute biliary pancreatitis, or some other reason for acute pancreatitis, and that’s the reason for the rehospitalization,” he said.

Dr. Kamal replied that they tried to control for other causes of pancreatitis by including ICD-9 codes for gallstone disease and by excluding patients with diagnoses of alcohol abuse.

WASHINGTON – Performed when recommended, cholecystecomy significantly decreases the risk of near-term rehospitalization for acute biliary pancreatitis, results of a retrospective study indicate.

Among more than 23,000 patients with mild to moderate acute biliary pancreatitis, less than 2% of those who underwent cholecystectomy within 30 days, as recommended under American Gastroenterological Association (AGA) guidelines, were rehospitalized for pancreatitis within 6 months.

In contrast, nearly 17% of patients who had cholecystectomy after 1 month or never had it were back in the hospital within half a year, said Dr. Ayesha Kamal, a postdoctoral research fellow at the Johns Hopkins Hospital in Baltimore.

“Cholecystectomy prevents future hospitalization for biliary pancreatitis,” she said at the annual Digestive Disease Week.

The study, based on claims data, also showed that adherence to AGA guidelines is fairly high, on the order of 75%, she said.

Acute pancreatitis is one of the most common gastrointestinal diseases in the United States, accounting for about 300,000 hospitalizations in 2009, at a total cost of about $2.6 billion.

Gallstone disease is the most common cause of acute pancreatitis, responsible for an estimated 40% of all cases, she said.

Guidelines from the AGA and other organizations recommend cholecystectomy either during the same hospitalization for acute biliary pancreatitis, or within 4 weeks.

To see whether clinicians were adhering to the AGA guidelines and whether the guideline-recommended timing of cholecystectomy made a difference, Dr. Kamal and colleagues analyzed data from the MarketScan Commercial Claims & Encounters database, which includes individual-level clinical utilization data for both inpatient and outpatient visits paid for by employer-sponsored health plans.

They looked at data both on patients who were treated in accordance with guidelines (first hospitalization for mild to moderate acute biliary pancreatitis, with cholecystectomy performed either on the day of hospitalization or within 30 days), and outside of the guidelines (no cholecystectomy, or cholecystectomy performed later than 30 days after the index hospitalization).

They assessed recurrences within 30 days of follow-up by International Classification of Diseases, 9th Revision (ICD-9) codes for acute pancreatitis and gallstone disease.

Combing through 8.8 million adult inpatient encounters for acute biliary pancreatitis, they excluded those patients with a diagnosis of severe or chronic pancreatitis, alcohol abuse, less than 30 days of follow-up, deaths during hospitalization, discharge to hospice, and those with a length of stay longer than 30 days.

This left them with a final cohort of 23,515 patients with mild to moderate acute biliary pancreatitis.

They found that 61% of patients had cholecystectomy during their initial hospitalizations, and an additional 14% had the surgery during a subsequent hospitalization within 30 days. Of the remaining patients, 7% had cholecystectomies after 30 days, and 18% never had one.

Among patients treated under the guidelines, 1.3% who had their gallbladders removed during the initial hospitalization had a pancreatitis recurrence within 6 months, and 0.2% had a recurrence more than 6 months later.

In contrast, 36.7% of patients who had a cholecystectomy more than a month after their first hospitalization for pancreatitis had a recurrence within 6 months, and 4.5% had a recurrence after 6 months.

Among patients who never underwent cholecystectomy, the respective recurrence rates were 5.4% and 1.1%.

“One in six patients who did not receive a cholecystectomy within 30 days will be hospitalized again within 6 months,” Dr. Kamal said.

She acknowledged that the study was limited by the authors’ inability to confirm acute biliary pancreatitis with chart review, and by the limitations of the database, which is confined to adults younger than 65 with employer-sponsored medical plans.

In the question and answer portion of the presentation, Dr. Nirav Thosani, a gastroenterologist at Memorial Hermann Hospital in Houston, noted that ICD-9 codes do not distinguish between different types of pancreatitis.

“It might be possible that those patients who never had cholecystectomy never had acute biliary pancreatitis, or some other reason for acute pancreatitis, and that’s the reason for the rehospitalization,” he said.

Dr. Kamal replied that they tried to control for other causes of pancreatitis by including ICD-9 codes for gallstone disease and by excluding patients with diagnoses of alcohol abuse.

WASHINGTON – Performed when recommended, cholecystecomy significantly decreases the risk of near-term rehospitalization for acute biliary pancreatitis, results of a retrospective study indicate.

Among more than 23,000 patients with mild to moderate acute biliary pancreatitis, less than 2% of those who underwent cholecystectomy within 30 days, as recommended under American Gastroenterological Association (AGA) guidelines, were rehospitalized for pancreatitis within 6 months.

In contrast, nearly 17% of patients who had cholecystectomy after 1 month or never had it were back in the hospital within half a year, said Dr. Ayesha Kamal, a postdoctoral research fellow at the Johns Hopkins Hospital in Baltimore.

“Cholecystectomy prevents future hospitalization for biliary pancreatitis,” she said at the annual Digestive Disease Week.

The study, based on claims data, also showed that adherence to AGA guidelines is fairly high, on the order of 75%, she said.

Acute pancreatitis is one of the most common gastrointestinal diseases in the United States, accounting for about 300,000 hospitalizations in 2009, at a total cost of about $2.6 billion.

Gallstone disease is the most common cause of acute pancreatitis, responsible for an estimated 40% of all cases, she said.

Guidelines from the AGA and other organizations recommend cholecystectomy either during the same hospitalization for acute biliary pancreatitis, or within 4 weeks.

To see whether clinicians were adhering to the AGA guidelines and whether the guideline-recommended timing of cholecystectomy made a difference, Dr. Kamal and colleagues analyzed data from the MarketScan Commercial Claims & Encounters database, which includes individual-level clinical utilization data for both inpatient and outpatient visits paid for by employer-sponsored health plans.

They looked at data both on patients who were treated in accordance with guidelines (first hospitalization for mild to moderate acute biliary pancreatitis, with cholecystectomy performed either on the day of hospitalization or within 30 days), and outside of the guidelines (no cholecystectomy, or cholecystectomy performed later than 30 days after the index hospitalization).

They assessed recurrences within 30 days of follow-up by International Classification of Diseases, 9th Revision (ICD-9) codes for acute pancreatitis and gallstone disease.

Combing through 8.8 million adult inpatient encounters for acute biliary pancreatitis, they excluded those patients with a diagnosis of severe or chronic pancreatitis, alcohol abuse, less than 30 days of follow-up, deaths during hospitalization, discharge to hospice, and those with a length of stay longer than 30 days.

This left them with a final cohort of 23,515 patients with mild to moderate acute biliary pancreatitis.

They found that 61% of patients had cholecystectomy during their initial hospitalizations, and an additional 14% had the surgery during a subsequent hospitalization within 30 days. Of the remaining patients, 7% had cholecystectomies after 30 days, and 18% never had one.

Among patients treated under the guidelines, 1.3% who had their gallbladders removed during the initial hospitalization had a pancreatitis recurrence within 6 months, and 0.2% had a recurrence more than 6 months later.

In contrast, 36.7% of patients who had a cholecystectomy more than a month after their first hospitalization for pancreatitis had a recurrence within 6 months, and 4.5% had a recurrence after 6 months.

Among patients who never underwent cholecystectomy, the respective recurrence rates were 5.4% and 1.1%.

“One in six patients who did not receive a cholecystectomy within 30 days will be hospitalized again within 6 months,” Dr. Kamal said.

She acknowledged that the study was limited by the authors’ inability to confirm acute biliary pancreatitis with chart review, and by the limitations of the database, which is confined to adults younger than 65 with employer-sponsored medical plans.

In the question and answer portion of the presentation, Dr. Nirav Thosani, a gastroenterologist at Memorial Hermann Hospital in Houston, noted that ICD-9 codes do not distinguish between different types of pancreatitis.

“It might be possible that those patients who never had cholecystectomy never had acute biliary pancreatitis, or some other reason for acute pancreatitis, and that’s the reason for the rehospitalization,” he said.

Dr. Kamal replied that they tried to control for other causes of pancreatitis by including ICD-9 codes for gallstone disease and by excluding patients with diagnoses of alcohol abuse.

Transgender youth and young adults suffer a significantly greater burden of mental health conditions and poor mental health outcomes than do nontransgender individuals, known as cisgender individuals, according to a recent study.

“Findings point to the need for gender-affirming mental health services and interventions to support transgender youth,” reported Sari L. Reisner, Sc.D., of Harvard T.H. Chan School of Public Health, Boston (J. Adolesc. Health 2015;56:274-9). “Community-based clinics should be prepared to provide mental health services or referrals for transgender patients.”

Dr. Reisner and his colleagues retrospectively analyzed medical records to compare the mental health outcomes of 106 female-to-male and 74 male-to-female transgender patients, aged 12-29 years, to 180 cisgender controls matched by gender identity, age, race/ethnicity, and visit date at a community health center in Boston between 2002 and 2011.

Cisgender refers to an individual whose self-identified gender identity matches his or her biological sex assigned at birth.

The transgender patients had four times the risk for depression, compared with the matched control patients (50.6% vs. 20.6%; relative risk = 3.95) and more than three times the risk for anxiety (26.7% vs. 10.0%; RR = 3.27), suicide ideation (31.1% vs. 11.1%; RR = 3.61) and suicide attempts (17.2% vs. 6.1%; RR = 3.20). Transgender individuals were more than four times more likely than were cisgender patients to self-harm without suicidal intent (16.7% vs. 4.4%; RR = 4.30).

Overall, 22.8% of transgender patients, compared with 11.1% of cisgender patients, used inpatient mental health care services (RR = 2.36), and 45.6% of transgender patients, compared with 16.1% of cisgender ones, accessed outpatient mental health services (RR = 4.36).

“The elevated mental health burden among transgender youth is hypothesized to result from experiences of social stress such as family rejection, bullying, violence, victimization, and discrimination, which occur due to disadvantaged social status,” all confounders not accounted for if present for these patients, the authors noted. On the other hand, the study’s lack of reliance on a gender identity disorder diagnosis “offers unique comparative data that directly compare the health and well-being of transgender and cisgender youth using a nonpathological perspective of gender variation,” they added.

Other potential limitations of the study were that transgender patients’ greater use of mental health services could have inflated prevalence estimates and that the findings, for an urban population, may not generalize to other geographic or clinical settings.

“Future research is needed to contextualize the mental health concerns of transgender adolescent and emerging adult patients in community-based clinic settings, including prospective assessment of social stressors and mental health symptoms and diagnoses over time,” the authors wrote.

The research was supported by the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors reported no relevant financial disclosures.

Transgender youth and young adults suffer a significantly greater burden of mental health conditions and poor mental health outcomes than do nontransgender individuals, known as cisgender individuals, according to a recent study.

“Findings point to the need for gender-affirming mental health services and interventions to support transgender youth,” reported Sari L. Reisner, Sc.D., of Harvard T.H. Chan School of Public Health, Boston (J. Adolesc. Health 2015;56:274-9). “Community-based clinics should be prepared to provide mental health services or referrals for transgender patients.”

Dr. Reisner and his colleagues retrospectively analyzed medical records to compare the mental health outcomes of 106 female-to-male and 74 male-to-female transgender patients, aged 12-29 years, to 180 cisgender controls matched by gender identity, age, race/ethnicity, and visit date at a community health center in Boston between 2002 and 2011.

Cisgender refers to an individual whose self-identified gender identity matches his or her biological sex assigned at birth.

The transgender patients had four times the risk for depression, compared with the matched control patients (50.6% vs. 20.6%; relative risk = 3.95) and more than three times the risk for anxiety (26.7% vs. 10.0%; RR = 3.27), suicide ideation (31.1% vs. 11.1%; RR = 3.61) and suicide attempts (17.2% vs. 6.1%; RR = 3.20). Transgender individuals were more than four times more likely than were cisgender patients to self-harm without suicidal intent (16.7% vs. 4.4%; RR = 4.30).

Overall, 22.8% of transgender patients, compared with 11.1% of cisgender patients, used inpatient mental health care services (RR = 2.36), and 45.6% of transgender patients, compared with 16.1% of cisgender ones, accessed outpatient mental health services (RR = 4.36).

“The elevated mental health burden among transgender youth is hypothesized to result from experiences of social stress such as family rejection, bullying, violence, victimization, and discrimination, which occur due to disadvantaged social status,” all confounders not accounted for if present for these patients, the authors noted. On the other hand, the study’s lack of reliance on a gender identity disorder diagnosis “offers unique comparative data that directly compare the health and well-being of transgender and cisgender youth using a nonpathological perspective of gender variation,” they added.

Other potential limitations of the study were that transgender patients’ greater use of mental health services could have inflated prevalence estimates and that the findings, for an urban population, may not generalize to other geographic or clinical settings.

“Future research is needed to contextualize the mental health concerns of transgender adolescent and emerging adult patients in community-based clinic settings, including prospective assessment of social stressors and mental health symptoms and diagnoses over time,” the authors wrote.

The research was supported by the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors reported no relevant financial disclosures.

Transgender youth and young adults suffer a significantly greater burden of mental health conditions and poor mental health outcomes than do nontransgender individuals, known as cisgender individuals, according to a recent study.

“Findings point to the need for gender-affirming mental health services and interventions to support transgender youth,” reported Sari L. Reisner, Sc.D., of Harvard T.H. Chan School of Public Health, Boston (J. Adolesc. Health 2015;56:274-9). “Community-based clinics should be prepared to provide mental health services or referrals for transgender patients.”

Dr. Reisner and his colleagues retrospectively analyzed medical records to compare the mental health outcomes of 106 female-to-male and 74 male-to-female transgender patients, aged 12-29 years, to 180 cisgender controls matched by gender identity, age, race/ethnicity, and visit date at a community health center in Boston between 2002 and 2011.

Cisgender refers to an individual whose self-identified gender identity matches his or her biological sex assigned at birth.

The transgender patients had four times the risk for depression, compared with the matched control patients (50.6% vs. 20.6%; relative risk = 3.95) and more than three times the risk for anxiety (26.7% vs. 10.0%; RR = 3.27), suicide ideation (31.1% vs. 11.1%; RR = 3.61) and suicide attempts (17.2% vs. 6.1%; RR = 3.20). Transgender individuals were more than four times more likely than were cisgender patients to self-harm without suicidal intent (16.7% vs. 4.4%; RR = 4.30).

Overall, 22.8% of transgender patients, compared with 11.1% of cisgender patients, used inpatient mental health care services (RR = 2.36), and 45.6% of transgender patients, compared with 16.1% of cisgender ones, accessed outpatient mental health services (RR = 4.36).

“The elevated mental health burden among transgender youth is hypothesized to result from experiences of social stress such as family rejection, bullying, violence, victimization, and discrimination, which occur due to disadvantaged social status,” all confounders not accounted for if present for these patients, the authors noted. On the other hand, the study’s lack of reliance on a gender identity disorder diagnosis “offers unique comparative data that directly compare the health and well-being of transgender and cisgender youth using a nonpathological perspective of gender variation,” they added.

Other potential limitations of the study were that transgender patients’ greater use of mental health services could have inflated prevalence estimates and that the findings, for an urban population, may not generalize to other geographic or clinical settings.

“Future research is needed to contextualize the mental health concerns of transgender adolescent and emerging adult patients in community-based clinic settings, including prospective assessment of social stressors and mental health symptoms and diagnoses over time,” the authors wrote.

The research was supported by the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors reported no relevant financial disclosures.