User login
Material can dissolve blood clots more efficiently, team says
Image by Kevin MacKenzie
Researchers say they have developed a thrombolytic material that can be condensed on a blood clot by means of a magnetic field.
Experiments suggest the material can dissolve clots up to 4000 times more efficiently than thrombolytic agents currently in use.
Vladimir Vinogradov, PhD, of ITMO University in St Petersburg, Russia, and his colleagues described the material in Scientific Reports.
“We prepared a thrombolytic colloid and tested its effects on an artificial blood clot obtained from plasma and blood of humans and thrombus extracted from patients,” Dr Vinogradov said.
“The results may soon allow us to try out the new thrombolytic system on mammals. Now, we are preparing for preclinical studies.”
Specifically, Dr Vinogradov and his colleagues produced a composite material that can deliver thrombolytic enzymes in a targeted manner. The material is composed of a porous magnetite framework and molecules of urokinase, an enzyme frequently used as a thrombolytic agent.
The composite can be used to create thrombolytic coating for artificial blood vessels and stable injectable solutions made of nanoparticles that can be localized near the clot by means of an external magnetic field.
The magnetite framework also protects enzymes from various inhibitors that are present in the blood and can deactivate thrombolytic medications.
“Usually, in order to achieve a prolonged effect for such drugs, the enzyme is placed inside a polymeric matrix,” said study author Andrey Drozdov, of ITMO University.
“The enzyme is then gradually released from the matrix and eventually loses all activity. We, on the other hand, experimentally demonstrated that enzymes protected using our approach do not lose therapeutic properties over extended periods of time and even after repeated use. The rate at which the new drug can dissolve the clot outperforms unprotected enzymes by about 4000 times.”
The researchers also believe the material is safe for humans because it is made of components that are already approved for intravenous injection. 
Image by Kevin MacKenzie
Researchers say they have developed a thrombolytic material that can be condensed on a blood clot by means of a magnetic field.
Experiments suggest the material can dissolve clots up to 4000 times more efficiently than thrombolytic agents currently in use.
Vladimir Vinogradov, PhD, of ITMO University in St Petersburg, Russia, and his colleagues described the material in Scientific Reports.
“We prepared a thrombolytic colloid and tested its effects on an artificial blood clot obtained from plasma and blood of humans and thrombus extracted from patients,” Dr Vinogradov said.
“The results may soon allow us to try out the new thrombolytic system on mammals. Now, we are preparing for preclinical studies.”
Specifically, Dr Vinogradov and his colleagues produced a composite material that can deliver thrombolytic enzymes in a targeted manner. The material is composed of a porous magnetite framework and molecules of urokinase, an enzyme frequently used as a thrombolytic agent.
The composite can be used to create thrombolytic coating for artificial blood vessels and stable injectable solutions made of nanoparticles that can be localized near the clot by means of an external magnetic field.
The magnetite framework also protects enzymes from various inhibitors that are present in the blood and can deactivate thrombolytic medications.
“Usually, in order to achieve a prolonged effect for such drugs, the enzyme is placed inside a polymeric matrix,” said study author Andrey Drozdov, of ITMO University.
“The enzyme is then gradually released from the matrix and eventually loses all activity. We, on the other hand, experimentally demonstrated that enzymes protected using our approach do not lose therapeutic properties over extended periods of time and even after repeated use. The rate at which the new drug can dissolve the clot outperforms unprotected enzymes by about 4000 times.”
The researchers also believe the material is safe for humans because it is made of components that are already approved for intravenous injection.
Image by Kevin MacKenzie
Researchers say they have developed a thrombolytic material that can be condensed on a blood clot by means of a magnetic field.
Experiments suggest the material can dissolve clots up to 4000 times more efficiently than thrombolytic agents currently in use.
Vladimir Vinogradov, PhD, of ITMO University in St Petersburg, Russia, and his colleagues described the material in Scientific Reports.
“We prepared a thrombolytic colloid and tested its effects on an artificial blood clot obtained from plasma and blood of humans and thrombus extracted from patients,” Dr Vinogradov said.
“The results may soon allow us to try out the new thrombolytic system on mammals. Now, we are preparing for preclinical studies.”
Specifically, Dr Vinogradov and his colleagues produced a composite material that can deliver thrombolytic enzymes in a targeted manner. The material is composed of a porous magnetite framework and molecules of urokinase, an enzyme frequently used as a thrombolytic agent.
The composite can be used to create thrombolytic coating for artificial blood vessels and stable injectable solutions made of nanoparticles that can be localized near the clot by means of an external magnetic field.
The magnetite framework also protects enzymes from various inhibitors that are present in the blood and can deactivate thrombolytic medications.
“Usually, in order to achieve a prolonged effect for such drugs, the enzyme is placed inside a polymeric matrix,” said study author Andrey Drozdov, of ITMO University.
“The enzyme is then gradually released from the matrix and eventually loses all activity. We, on the other hand, experimentally demonstrated that enzymes protected using our approach do not lose therapeutic properties over extended periods of time and even after repeated use. The rate at which the new drug can dissolve the clot outperforms unprotected enzymes by about 4000 times.”
The researchers also believe the material is safe for humans because it is made of components that are already approved for intravenous injection.
NICE recommends approval for bosutinib
Photo courtesy of CDC
The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending approval for bosutinib (Bosulif), a tyrosine kinase inhibitor used to treat certain patients with chronic myeloid leukemia (CML).
NICE is recommending that bosutinib be made available through normal National Health Service (NHS) funding channels so patients don’t have to apply to the Cancer Drugs Fund (CDF) to obtain it.
The CDF is money the government sets aside to pay for cancer drugs that haven’t been approved by NICE and aren’t available within the NHS in England.
Following the decision to reform the CDF earlier this year, NICE began to reappraise all drugs currently in the CDF in April. Bosutinib is the first drug to be looked at through this reconsideration process.
Bosutinib has conditional approval from the European Commission to treat adults with Philadelphia-chromosome-positive CML in chronic phase, accelerated phase, or blast phase, but only if those patients have previously received one or more tyrosine kinase inhibitors and are not considered eligible for treatment with imatinib, nilotinib, or dasatinib.
“People with this type of chronic myeloid leukemia, who haven’t responded to first- and second-line treatment or who experience severe side effects, have few or no treatment options left,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
“New patients who need this drug can be reassured that bosutinib should be made available for routine use within the NHS.”
The current list price of bosutinib is £45,000 per patient per year. However, the NHS has been offered a discount by Pfizer, the drug’s manufacturer.
NICE previously looked at bosutinib in 2013 but did not recommend the drug for use on the NHS at that time, saying the drug was not cost-effective. Bosutinib was then made available to patients via the CDF.
As part of the reappraisal process, Pfizer offered a discount for bosutinib. Taking this discount into consideration, as well as the limited treatment options for CML patients, NICE decided bosutinib is cost-effective.
“The company positively engaged with our CDF reconsideration process and demonstrated that their drug can be cost-effective, which resulted in a positive recommendation,” Longson said. “This decision, when implemented, frees up funding in the CDF, which can be spent on other new and innovative cancer treatments.”
NICE’s final draft guidance is now with consultees who have the opportunity to appeal against the decision or notify NICE of any factual errors. The appeal period will close at 5 pm on July 21, 2016.
Until the final decision is published, bosutinib will still be available to new and existing patients through the old CDF.
Photo courtesy of CDC
The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending approval for bosutinib (Bosulif), a tyrosine kinase inhibitor used to treat certain patients with chronic myeloid leukemia (CML).
NICE is recommending that bosutinib be made available through normal National Health Service (NHS) funding channels so patients don’t have to apply to the Cancer Drugs Fund (CDF) to obtain it.
The CDF is money the government sets aside to pay for cancer drugs that haven’t been approved by NICE and aren’t available within the NHS in England.
Following the decision to reform the CDF earlier this year, NICE began to reappraise all drugs currently in the CDF in April. Bosutinib is the first drug to be looked at through this reconsideration process.
Bosutinib has conditional approval from the European Commission to treat adults with Philadelphia-chromosome-positive CML in chronic phase, accelerated phase, or blast phase, but only if those patients have previously received one or more tyrosine kinase inhibitors and are not considered eligible for treatment with imatinib, nilotinib, or dasatinib.
“People with this type of chronic myeloid leukemia, who haven’t responded to first- and second-line treatment or who experience severe side effects, have few or no treatment options left,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
“New patients who need this drug can be reassured that bosutinib should be made available for routine use within the NHS.”
The current list price of bosutinib is £45,000 per patient per year. However, the NHS has been offered a discount by Pfizer, the drug’s manufacturer.
NICE previously looked at bosutinib in 2013 but did not recommend the drug for use on the NHS at that time, saying the drug was not cost-effective. Bosutinib was then made available to patients via the CDF.
As part of the reappraisal process, Pfizer offered a discount for bosutinib. Taking this discount into consideration, as well as the limited treatment options for CML patients, NICE decided bosutinib is cost-effective.
“The company positively engaged with our CDF reconsideration process and demonstrated that their drug can be cost-effective, which resulted in a positive recommendation,” Longson said. “This decision, when implemented, frees up funding in the CDF, which can be spent on other new and innovative cancer treatments.”
NICE’s final draft guidance is now with consultees who have the opportunity to appeal against the decision or notify NICE of any factual errors. The appeal period will close at 5 pm on July 21, 2016.
Until the final decision is published, bosutinib will still be available to new and existing patients through the old CDF.
Photo courtesy of CDC
The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending approval for bosutinib (Bosulif), a tyrosine kinase inhibitor used to treat certain patients with chronic myeloid leukemia (CML).
NICE is recommending that bosutinib be made available through normal National Health Service (NHS) funding channels so patients don’t have to apply to the Cancer Drugs Fund (CDF) to obtain it.
The CDF is money the government sets aside to pay for cancer drugs that haven’t been approved by NICE and aren’t available within the NHS in England.
Following the decision to reform the CDF earlier this year, NICE began to reappraise all drugs currently in the CDF in April. Bosutinib is the first drug to be looked at through this reconsideration process.
Bosutinib has conditional approval from the European Commission to treat adults with Philadelphia-chromosome-positive CML in chronic phase, accelerated phase, or blast phase, but only if those patients have previously received one or more tyrosine kinase inhibitors and are not considered eligible for treatment with imatinib, nilotinib, or dasatinib.
“People with this type of chronic myeloid leukemia, who haven’t responded to first- and second-line treatment or who experience severe side effects, have few or no treatment options left,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
“New patients who need this drug can be reassured that bosutinib should be made available for routine use within the NHS.”
The current list price of bosutinib is £45,000 per patient per year. However, the NHS has been offered a discount by Pfizer, the drug’s manufacturer.
NICE previously looked at bosutinib in 2013 but did not recommend the drug for use on the NHS at that time, saying the drug was not cost-effective. Bosutinib was then made available to patients via the CDF.
As part of the reappraisal process, Pfizer offered a discount for bosutinib. Taking this discount into consideration, as well as the limited treatment options for CML patients, NICE decided bosutinib is cost-effective.
“The company positively engaged with our CDF reconsideration process and demonstrated that their drug can be cost-effective, which resulted in a positive recommendation,” Longson said. “This decision, when implemented, frees up funding in the CDF, which can be spent on other new and innovative cancer treatments.”
NICE’s final draft guidance is now with consultees who have the opportunity to appeal against the decision or notify NICE of any factual errors. The appeal period will close at 5 pm on July 21, 2016.
Until the final decision is published, bosutinib will still be available to new and existing patients through the old CDF.
New data propel headache neuromodulation devices toward approval
WASHINGTON – Encouraging data on an external vagal nerve stimulator and a minimally invasive system that targets the sphenopalatine ganglion are propelling the two neuromodulation devices toward approval for headache, Stewart J. Tepper, MD, said at the Summit in Neurology & Psychiatry.
“This would bring to four the number of devices we now have available to us to treat headache,” said Dr. Tepper, director of research at the Dartmouth Headache Clinic, Lebanon, N.H. Two types are already available in the United States: a trigeminal nerve stimulator approved for migraine prevention and two brands of transcranial magnetic stimulators approved for acute treatment of migraine with aura.
Noninvasive vagal nerve stimulator
The gammaCore device (electroCore Medical) could be approved for cluster headache this year, Dr. Tepper said. A company spokesman said the company submitted its pivotal trial data to the Food and Drug Administration in 2015, but couldn’t offer any insight into how far the process has progressed.
“That application is currently under review, and we look forward to the FDA’s decision when it comes,” Eric Liebler, electroCore vice president for scientific, medical, and governmental affairs, said in an interview.
The gammaCore device is an external vagal nerve stimulator already approved in Canada and Europe for the treatment of primary headache disorders. In April 2016, it was approved in the United Kingdom as well, Dr. Tepper said at the meeting, sponsored by the Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.
The device is a small, handheld unit that the patient uses twice each day, and which transmits mild current to the vagal nerve. It’s activated over the carotid pulse point on the neck for about 90 seconds. It’s thought to work by suppressing excessive extracellular glutamate and suppressing cortical spreading depression, Dr. Tepper said.
The most recent data for the gammaCore device, presented at the annual meeting of the American Headache Society (AHS) in June, suggest that it could also be beneficial in chronic headache and in menstrual migraine.
A 12-week, open-label study of 51 women with menstrual migraine looked at pain intensity, analgesic use, and migraine disability. Women used the device prophylactically, six stimulations each day for 3 days before and after the onset of menstruation. The mean number of menstrual migraine days each month declined significantly from 7.2 to 4.7. About 40% of the group had at least a 50% reduction in migraine days. Pain intensity also decreased significantly, as well as did the number of doses of analgesics. There were significant improvements on both the Headache Impact Test and Migraine Disability Assessment. One subject discontinued treatment due to dizziness during stimulation.
An 8-week study on cluster headache was published in May and updated at the AHS meeting. Investigators randomized 87 patients with cluster headache to standard therapy alone or plus the gammaCore device. The PREVA (Prevention and Acute treatment of chronic cluster headache) study determined that dual therapy reduced the number of weekly attacks by four, compared with standard therapy. A total of 40% of patients experienced at least a 50% response rate, compared with 8% of controls. A subanalysis presented at the AHS meeting showed that 18% of the dual-therapy group experienced at least a 75% response rate.
Implantable sphenopalatine ganglion stimulator
Dr. Tepper is particularly excited about the Pulsante device, an implantable, wireless sphenopalatine ganglion (SPG) stimulator manufactured by Autonomic Technologies, which he called “a dramatic change in paradigm,” for the treatment of cluster headaches.
The system consists of a neurostimulator about the size of an almond and a lead with six electrodes. It’s inserted under local anesthetic via a small incision in the upper gum on the side in which the patient experiences symptoms. The electrodes are positioned along the SPG nerve and the neurostimulator is affixed to the zygomatic process.
A handheld wireless controller placed against the cheek activates the device and controls the intensity of stimulation, which is thought to work by blocking signals to the postganglionic parasympathetic fibers. Those fibers innervate facial structures and the cerebral and meningeal blood vessels and are implicated in the pain and accompanying autonomic symptoms of a cluster headache attack.
“You can literally see this device working right before your eyes,” he said. “Patients having a cluster attack will exhibit ptosis, red watering eyes, nose running, and as soon as the device is turned on, you see the lid come up, the eye turn white, and the tearing and runny nose stop. This is an objective correlate to a subjective pain response. It’s dramatic and exciting.”
The pivotal Pathway CH-1study that led to European Union approval was small – just 43 patients – but found that half the cluster attacks could be terminated within 15 minutes of onset. About half of the patients, who had a decades-long history of cluster headaches, experienced close to a 90% reduction in attack frequency.
The latest Pulsante data were also presented in June at the AHS meeting. Two papers – one with 24-month data from the pivotal trial, and one with 12-month data from an ongoing registry study – were overwhelmingly positive, Dr. Tepper said.
The 24-month follow-up data to the pivotal study found that 61% of patients experienced a therapeutic response to SPG stimulation. Most attacks (79%) responded to stimulation alone without the need for abortive therapy. Most patients (64%) also experienced clinical improvements in preventive medication use. Twenty-one were able to reduce or even eliminate the use of preventive medications.
The registry study provided data on 85 patients. Of these, 68% experienced at least a 50% reduction in attack frequency; some reported close to a 90% reduction. A third of patients actually experienced some period of remission, and some patients who were not initially responders became responders after a year of treatment. Acute medication use declined by 52% overall and by 82% in those considered therapeutic responders.
“These data are extremely encouraging,” Dr. Tepper said.
Adverse events are minimal and most are related to implantation. A safety study of 99 patients found that adverse events included sensory disbranch, pain, and swelling, which resolved in 90 days.
The U.S. Pathway CH-2 Cluster Headache Study is now underway and aims to enroll 120 patients. “If the data are positive on this, the company will go ahead and pursue U.S. approval,” Dr. Tepper said.
Dr. Tepper has received personal remuneration and research funding from a number of pharmaceutical companies. He holds stock in Autonomic Technologies.
On Twitter @alz_gal
WASHINGTON – Encouraging data on an external vagal nerve stimulator and a minimally invasive system that targets the sphenopalatine ganglion are propelling the two neuromodulation devices toward approval for headache, Stewart J. Tepper, MD, said at the Summit in Neurology & Psychiatry.
“This would bring to four the number of devices we now have available to us to treat headache,” said Dr. Tepper, director of research at the Dartmouth Headache Clinic, Lebanon, N.H. Two types are already available in the United States: a trigeminal nerve stimulator approved for migraine prevention and two brands of transcranial magnetic stimulators approved for acute treatment of migraine with aura.
Noninvasive vagal nerve stimulator
The gammaCore device (electroCore Medical) could be approved for cluster headache this year, Dr. Tepper said. A company spokesman said the company submitted its pivotal trial data to the Food and Drug Administration in 2015, but couldn’t offer any insight into how far the process has progressed.
“That application is currently under review, and we look forward to the FDA’s decision when it comes,” Eric Liebler, electroCore vice president for scientific, medical, and governmental affairs, said in an interview.
The gammaCore device is an external vagal nerve stimulator already approved in Canada and Europe for the treatment of primary headache disorders. In April 2016, it was approved in the United Kingdom as well, Dr. Tepper said at the meeting, sponsored by the Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.
The device is a small, handheld unit that the patient uses twice each day, and which transmits mild current to the vagal nerve. It’s activated over the carotid pulse point on the neck for about 90 seconds. It’s thought to work by suppressing excessive extracellular glutamate and suppressing cortical spreading depression, Dr. Tepper said.
The most recent data for the gammaCore device, presented at the annual meeting of the American Headache Society (AHS) in June, suggest that it could also be beneficial in chronic headache and in menstrual migraine.
A 12-week, open-label study of 51 women with menstrual migraine looked at pain intensity, analgesic use, and migraine disability. Women used the device prophylactically, six stimulations each day for 3 days before and after the onset of menstruation. The mean number of menstrual migraine days each month declined significantly from 7.2 to 4.7. About 40% of the group had at least a 50% reduction in migraine days. Pain intensity also decreased significantly, as well as did the number of doses of analgesics. There were significant improvements on both the Headache Impact Test and Migraine Disability Assessment. One subject discontinued treatment due to dizziness during stimulation.
An 8-week study on cluster headache was published in May and updated at the AHS meeting. Investigators randomized 87 patients with cluster headache to standard therapy alone or plus the gammaCore device. The PREVA (Prevention and Acute treatment of chronic cluster headache) study determined that dual therapy reduced the number of weekly attacks by four, compared with standard therapy. A total of 40% of patients experienced at least a 50% response rate, compared with 8% of controls. A subanalysis presented at the AHS meeting showed that 18% of the dual-therapy group experienced at least a 75% response rate.
Implantable sphenopalatine ganglion stimulator
Dr. Tepper is particularly excited about the Pulsante device, an implantable, wireless sphenopalatine ganglion (SPG) stimulator manufactured by Autonomic Technologies, which he called “a dramatic change in paradigm,” for the treatment of cluster headaches.
The system consists of a neurostimulator about the size of an almond and a lead with six electrodes. It’s inserted under local anesthetic via a small incision in the upper gum on the side in which the patient experiences symptoms. The electrodes are positioned along the SPG nerve and the neurostimulator is affixed to the zygomatic process.
A handheld wireless controller placed against the cheek activates the device and controls the intensity of stimulation, which is thought to work by blocking signals to the postganglionic parasympathetic fibers. Those fibers innervate facial structures and the cerebral and meningeal blood vessels and are implicated in the pain and accompanying autonomic symptoms of a cluster headache attack.
“You can literally see this device working right before your eyes,” he said. “Patients having a cluster attack will exhibit ptosis, red watering eyes, nose running, and as soon as the device is turned on, you see the lid come up, the eye turn white, and the tearing and runny nose stop. This is an objective correlate to a subjective pain response. It’s dramatic and exciting.”
The pivotal Pathway CH-1study that led to European Union approval was small – just 43 patients – but found that half the cluster attacks could be terminated within 15 minutes of onset. About half of the patients, who had a decades-long history of cluster headaches, experienced close to a 90% reduction in attack frequency.
The latest Pulsante data were also presented in June at the AHS meeting. Two papers – one with 24-month data from the pivotal trial, and one with 12-month data from an ongoing registry study – were overwhelmingly positive, Dr. Tepper said.
The 24-month follow-up data to the pivotal study found that 61% of patients experienced a therapeutic response to SPG stimulation. Most attacks (79%) responded to stimulation alone without the need for abortive therapy. Most patients (64%) also experienced clinical improvements in preventive medication use. Twenty-one were able to reduce or even eliminate the use of preventive medications.
The registry study provided data on 85 patients. Of these, 68% experienced at least a 50% reduction in attack frequency; some reported close to a 90% reduction. A third of patients actually experienced some period of remission, and some patients who were not initially responders became responders after a year of treatment. Acute medication use declined by 52% overall and by 82% in those considered therapeutic responders.
“These data are extremely encouraging,” Dr. Tepper said.
Adverse events are minimal and most are related to implantation. A safety study of 99 patients found that adverse events included sensory disbranch, pain, and swelling, which resolved in 90 days.
The U.S. Pathway CH-2 Cluster Headache Study is now underway and aims to enroll 120 patients. “If the data are positive on this, the company will go ahead and pursue U.S. approval,” Dr. Tepper said.
Dr. Tepper has received personal remuneration and research funding from a number of pharmaceutical companies. He holds stock in Autonomic Technologies.
On Twitter @alz_gal
WASHINGTON – Encouraging data on an external vagal nerve stimulator and a minimally invasive system that targets the sphenopalatine ganglion are propelling the two neuromodulation devices toward approval for headache, Stewart J. Tepper, MD, said at the Summit in Neurology & Psychiatry.
“This would bring to four the number of devices we now have available to us to treat headache,” said Dr. Tepper, director of research at the Dartmouth Headache Clinic, Lebanon, N.H. Two types are already available in the United States: a trigeminal nerve stimulator approved for migraine prevention and two brands of transcranial magnetic stimulators approved for acute treatment of migraine with aura.
Noninvasive vagal nerve stimulator
The gammaCore device (electroCore Medical) could be approved for cluster headache this year, Dr. Tepper said. A company spokesman said the company submitted its pivotal trial data to the Food and Drug Administration in 2015, but couldn’t offer any insight into how far the process has progressed.
“That application is currently under review, and we look forward to the FDA’s decision when it comes,” Eric Liebler, electroCore vice president for scientific, medical, and governmental affairs, said in an interview.
The gammaCore device is an external vagal nerve stimulator already approved in Canada and Europe for the treatment of primary headache disorders. In April 2016, it was approved in the United Kingdom as well, Dr. Tepper said at the meeting, sponsored by the Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.
The device is a small, handheld unit that the patient uses twice each day, and which transmits mild current to the vagal nerve. It’s activated over the carotid pulse point on the neck for about 90 seconds. It’s thought to work by suppressing excessive extracellular glutamate and suppressing cortical spreading depression, Dr. Tepper said.
The most recent data for the gammaCore device, presented at the annual meeting of the American Headache Society (AHS) in June, suggest that it could also be beneficial in chronic headache and in menstrual migraine.
A 12-week, open-label study of 51 women with menstrual migraine looked at pain intensity, analgesic use, and migraine disability. Women used the device prophylactically, six stimulations each day for 3 days before and after the onset of menstruation. The mean number of menstrual migraine days each month declined significantly from 7.2 to 4.7. About 40% of the group had at least a 50% reduction in migraine days. Pain intensity also decreased significantly, as well as did the number of doses of analgesics. There were significant improvements on both the Headache Impact Test and Migraine Disability Assessment. One subject discontinued treatment due to dizziness during stimulation.
An 8-week study on cluster headache was published in May and updated at the AHS meeting. Investigators randomized 87 patients with cluster headache to standard therapy alone or plus the gammaCore device. The PREVA (Prevention and Acute treatment of chronic cluster headache) study determined that dual therapy reduced the number of weekly attacks by four, compared with standard therapy. A total of 40% of patients experienced at least a 50% response rate, compared with 8% of controls. A subanalysis presented at the AHS meeting showed that 18% of the dual-therapy group experienced at least a 75% response rate.
Implantable sphenopalatine ganglion stimulator
Dr. Tepper is particularly excited about the Pulsante device, an implantable, wireless sphenopalatine ganglion (SPG) stimulator manufactured by Autonomic Technologies, which he called “a dramatic change in paradigm,” for the treatment of cluster headaches.
The system consists of a neurostimulator about the size of an almond and a lead with six electrodes. It’s inserted under local anesthetic via a small incision in the upper gum on the side in which the patient experiences symptoms. The electrodes are positioned along the SPG nerve and the neurostimulator is affixed to the zygomatic process.
A handheld wireless controller placed against the cheek activates the device and controls the intensity of stimulation, which is thought to work by blocking signals to the postganglionic parasympathetic fibers. Those fibers innervate facial structures and the cerebral and meningeal blood vessels and are implicated in the pain and accompanying autonomic symptoms of a cluster headache attack.
“You can literally see this device working right before your eyes,” he said. “Patients having a cluster attack will exhibit ptosis, red watering eyes, nose running, and as soon as the device is turned on, you see the lid come up, the eye turn white, and the tearing and runny nose stop. This is an objective correlate to a subjective pain response. It’s dramatic and exciting.”
The pivotal Pathway CH-1study that led to European Union approval was small – just 43 patients – but found that half the cluster attacks could be terminated within 15 minutes of onset. About half of the patients, who had a decades-long history of cluster headaches, experienced close to a 90% reduction in attack frequency.
The latest Pulsante data were also presented in June at the AHS meeting. Two papers – one with 24-month data from the pivotal trial, and one with 12-month data from an ongoing registry study – were overwhelmingly positive, Dr. Tepper said.
The 24-month follow-up data to the pivotal study found that 61% of patients experienced a therapeutic response to SPG stimulation. Most attacks (79%) responded to stimulation alone without the need for abortive therapy. Most patients (64%) also experienced clinical improvements in preventive medication use. Twenty-one were able to reduce or even eliminate the use of preventive medications.
The registry study provided data on 85 patients. Of these, 68% experienced at least a 50% reduction in attack frequency; some reported close to a 90% reduction. A third of patients actually experienced some period of remission, and some patients who were not initially responders became responders after a year of treatment. Acute medication use declined by 52% overall and by 82% in those considered therapeutic responders.
“These data are extremely encouraging,” Dr. Tepper said.
Adverse events are minimal and most are related to implantation. A safety study of 99 patients found that adverse events included sensory disbranch, pain, and swelling, which resolved in 90 days.
The U.S. Pathway CH-2 Cluster Headache Study is now underway and aims to enroll 120 patients. “If the data are positive on this, the company will go ahead and pursue U.S. approval,” Dr. Tepper said.
Dr. Tepper has received personal remuneration and research funding from a number of pharmaceutical companies. He holds stock in Autonomic Technologies.
On Twitter @alz_gal
AT SUMMIT IN NEUROLOGY & PSYCHIATRY
QUIZ: How Much Do You Know about Treating Upper Extremity DVT?
[WpProQuiz 10] [WpProQuiz_toplist 10]
[WpProQuiz 10] [WpProQuiz_toplist 10]
[WpProQuiz 10] [WpProQuiz_toplist 10]
Patch of Hair Loss on the Scalp
The Diagnosis: Temporal Triangular Alopecia
Temporal triangular alopecia (TTA), also known as congenital triangular alopecia, was first described in the early 1900s.1 It presents clinically as a triangular-shaped area of nonscarring alopecia either unilaterally or bilaterally. Limited clinical data suggest that most unilateral cases are on the left frontotemporal region of the scalp. In bilateral cases, there may be asymmetry in size of the area involved.2 Dermatoscopically, TTA is characterized by decreased terminal hair follicle density as well as the presence of vellus hairs with an absence of inflammation.3 The majority of TTA is noted between birth and 6 years of life with the areas staying stable thereafter. Large areas of TTA may suggest cerebello-trigeminal-dermal dysplasia (Gomez-Lopez-Hernandez syndrome), a rare neurocutaneous syndrome characterized by rhombencephalosynapsis, trigeminal anesthesia, and parietooccipital alopecia (Online Mendelian Inheritance in Man 601853).4 Although TTA is largely idiopathic, it has been suggested that the trait may be paradominant, whereby a postzygotic loss of the wild-type allele in a heterozygotic state causes triangular alopecia and reflects hamartomatous mosaicism.5 It also is an important mimicker of alopecia areata. Correct identification prevents unnecessary treatment to the areas of the scalp. Hair restoration surgery has been reported as a tool to treat this disorder.6
- Tosti A. Congenital triangular alopecia. report of fourteen cases. J Am Acad Dermatol. 1987;16:991-993.
- Armstrong DK, Burrows D. Congenital triangular alopecia. Pediatr Dermatol. 1996;13:394-396.
- Iorizzo M, Pazzaglia M, Starace M, et al. Videodermoscopy: a useful tool for diagnosing congenital triangular alopecia. Pediatr Dermatol. 2008;25:652-654.
- Assoly P, Happle R. A hairy paradox: congenital triangular alopecia with a central hair tuft. Dermatology. 2010;221:107-109.
- Happle R. Congenital triangular alopecia may be categorized as a paradominant trait. Eur J Dermatol. 2003;13:346-347.
- Wu WY, Otberg N, Kang H, et al. Successful treatment of temporal triangular alopecia by hair restoration surgery using follicular unit transplantation. Dermatol Surg. 2009;35:1307-1310.
The Diagnosis: Temporal Triangular Alopecia
Temporal triangular alopecia (TTA), also known as congenital triangular alopecia, was first described in the early 1900s.1 It presents clinically as a triangular-shaped area of nonscarring alopecia either unilaterally or bilaterally. Limited clinical data suggest that most unilateral cases are on the left frontotemporal region of the scalp. In bilateral cases, there may be asymmetry in size of the area involved.2 Dermatoscopically, TTA is characterized by decreased terminal hair follicle density as well as the presence of vellus hairs with an absence of inflammation.3 The majority of TTA is noted between birth and 6 years of life with the areas staying stable thereafter. Large areas of TTA may suggest cerebello-trigeminal-dermal dysplasia (Gomez-Lopez-Hernandez syndrome), a rare neurocutaneous syndrome characterized by rhombencephalosynapsis, trigeminal anesthesia, and parietooccipital alopecia (Online Mendelian Inheritance in Man 601853).4 Although TTA is largely idiopathic, it has been suggested that the trait may be paradominant, whereby a postzygotic loss of the wild-type allele in a heterozygotic state causes triangular alopecia and reflects hamartomatous mosaicism.5 It also is an important mimicker of alopecia areata. Correct identification prevents unnecessary treatment to the areas of the scalp. Hair restoration surgery has been reported as a tool to treat this disorder.6
The Diagnosis: Temporal Triangular Alopecia
Temporal triangular alopecia (TTA), also known as congenital triangular alopecia, was first described in the early 1900s.1 It presents clinically as a triangular-shaped area of nonscarring alopecia either unilaterally or bilaterally. Limited clinical data suggest that most unilateral cases are on the left frontotemporal region of the scalp. In bilateral cases, there may be asymmetry in size of the area involved.2 Dermatoscopically, TTA is characterized by decreased terminal hair follicle density as well as the presence of vellus hairs with an absence of inflammation.3 The majority of TTA is noted between birth and 6 years of life with the areas staying stable thereafter. Large areas of TTA may suggest cerebello-trigeminal-dermal dysplasia (Gomez-Lopez-Hernandez syndrome), a rare neurocutaneous syndrome characterized by rhombencephalosynapsis, trigeminal anesthesia, and parietooccipital alopecia (Online Mendelian Inheritance in Man 601853).4 Although TTA is largely idiopathic, it has been suggested that the trait may be paradominant, whereby a postzygotic loss of the wild-type allele in a heterozygotic state causes triangular alopecia and reflects hamartomatous mosaicism.5 It also is an important mimicker of alopecia areata. Correct identification prevents unnecessary treatment to the areas of the scalp. Hair restoration surgery has been reported as a tool to treat this disorder.6
- Tosti A. Congenital triangular alopecia. report of fourteen cases. J Am Acad Dermatol. 1987;16:991-993.
- Armstrong DK, Burrows D. Congenital triangular alopecia. Pediatr Dermatol. 1996;13:394-396.
- Iorizzo M, Pazzaglia M, Starace M, et al. Videodermoscopy: a useful tool for diagnosing congenital triangular alopecia. Pediatr Dermatol. 2008;25:652-654.
- Assoly P, Happle R. A hairy paradox: congenital triangular alopecia with a central hair tuft. Dermatology. 2010;221:107-109.
- Happle R. Congenital triangular alopecia may be categorized as a paradominant trait. Eur J Dermatol. 2003;13:346-347.
- Wu WY, Otberg N, Kang H, et al. Successful treatment of temporal triangular alopecia by hair restoration surgery using follicular unit transplantation. Dermatol Surg. 2009;35:1307-1310.
- Tosti A. Congenital triangular alopecia. report of fourteen cases. J Am Acad Dermatol. 1987;16:991-993.
- Armstrong DK, Burrows D. Congenital triangular alopecia. Pediatr Dermatol. 1996;13:394-396.
- Iorizzo M, Pazzaglia M, Starace M, et al. Videodermoscopy: a useful tool for diagnosing congenital triangular alopecia. Pediatr Dermatol. 2008;25:652-654.
- Assoly P, Happle R. A hairy paradox: congenital triangular alopecia with a central hair tuft. Dermatology. 2010;221:107-109.
- Happle R. Congenital triangular alopecia may be categorized as a paradominant trait. Eur J Dermatol. 2003;13:346-347.
- Wu WY, Otberg N, Kang H, et al. Successful treatment of temporal triangular alopecia by hair restoration surgery using follicular unit transplantation. Dermatol Surg. 2009;35:1307-1310.
An 11-year-old girl presented for evaluation of a patch of hair loss on the right parietal scalp that had been present and stable for 2.5 years. Physical examination revealed a unilateral area of hair loss that was triangular in shape on the right parietal/temporal region, measuring 2.1×2.2 cm. Dermatoscope examination showed vellus hairs throughout. A hair-pull test was negative and the patient confirmed that the area had never been completely smooth. There were no associated symptoms and no family history of autoimmune disease or hair loss. Prior to presentation, the patient underwent a trial of intralesional steroids and topical steroids to the area without effect.
Hospital costs higher for patients discharged to postacute care
The average cost of U.S. hospital stays for injury or illness in patients discharged to postacute care is more than double that of visits with routine discharges, according to the Agency for Healthcare Research and Quality.
For patients who were discharged from hospitals to PAC, the average cost of an inpatient visit in 2013 was $16,900, compared with $8,300 for patients with routine discharges. The inpatient visits with PAC were almost twice as long as those with routine discharge – 7.0 days vs. 3.6 days – and patients with PAC-discharge visits were much older – 69.5% were aged 65 years or older, compared with 22.4% of visits with routine discharges, the AHRQ reported.
The AHRQ used data from the 2013 National Inpatient Sample (NIS) to estimates discharges to PAC for all types of payers and describe these discharges from the perspective of payers, patients, hospitals, conditions/procedures, and geographic regions.
The cost of stays varied considerably among the various PAC settings in 2013. Inpatient stays with discharge to home health agencies had the lowest average cost at $15,100, with skilled nursing facilities next at $16,600, followed by inpatient rehabilitation facilities at $24,200 and long-term-care hospitals at $36,800. Length of stays by PAC setting showed the same trend: those with discharge to home health agencies were shortest (6.2 days) and those with discharge to long-term-care hospitals were longest (13.5 days), the AHRQ said in the report.
Inpatient stays with discharge to PAC made up 22.3% of all hospital discharges in 2013, with the bulk being discharges to home health agencies (50.1%) and skilled nursing facilities (40.5%). Discharges to inpatient rehabilitation facilities made up 7.2% of all PAC visits, while those to long-term-care hospitals were just 2.2%, the data from the NIS show.
The average cost of U.S. hospital stays for injury or illness in patients discharged to postacute care is more than double that of visits with routine discharges, according to the Agency for Healthcare Research and Quality.
For patients who were discharged from hospitals to PAC, the average cost of an inpatient visit in 2013 was $16,900, compared with $8,300 for patients with routine discharges. The inpatient visits with PAC were almost twice as long as those with routine discharge – 7.0 days vs. 3.6 days – and patients with PAC-discharge visits were much older – 69.5% were aged 65 years or older, compared with 22.4% of visits with routine discharges, the AHRQ reported.
The AHRQ used data from the 2013 National Inpatient Sample (NIS) to estimates discharges to PAC for all types of payers and describe these discharges from the perspective of payers, patients, hospitals, conditions/procedures, and geographic regions.
The cost of stays varied considerably among the various PAC settings in 2013. Inpatient stays with discharge to home health agencies had the lowest average cost at $15,100, with skilled nursing facilities next at $16,600, followed by inpatient rehabilitation facilities at $24,200 and long-term-care hospitals at $36,800. Length of stays by PAC setting showed the same trend: those with discharge to home health agencies were shortest (6.2 days) and those with discharge to long-term-care hospitals were longest (13.5 days), the AHRQ said in the report.
Inpatient stays with discharge to PAC made up 22.3% of all hospital discharges in 2013, with the bulk being discharges to home health agencies (50.1%) and skilled nursing facilities (40.5%). Discharges to inpatient rehabilitation facilities made up 7.2% of all PAC visits, while those to long-term-care hospitals were just 2.2%, the data from the NIS show.
The average cost of U.S. hospital stays for injury or illness in patients discharged to postacute care is more than double that of visits with routine discharges, according to the Agency for Healthcare Research and Quality.
For patients who were discharged from hospitals to PAC, the average cost of an inpatient visit in 2013 was $16,900, compared with $8,300 for patients with routine discharges. The inpatient visits with PAC were almost twice as long as those with routine discharge – 7.0 days vs. 3.6 days – and patients with PAC-discharge visits were much older – 69.5% were aged 65 years or older, compared with 22.4% of visits with routine discharges, the AHRQ reported.
The AHRQ used data from the 2013 National Inpatient Sample (NIS) to estimates discharges to PAC for all types of payers and describe these discharges from the perspective of payers, patients, hospitals, conditions/procedures, and geographic regions.
The cost of stays varied considerably among the various PAC settings in 2013. Inpatient stays with discharge to home health agencies had the lowest average cost at $15,100, with skilled nursing facilities next at $16,600, followed by inpatient rehabilitation facilities at $24,200 and long-term-care hospitals at $36,800. Length of stays by PAC setting showed the same trend: those with discharge to home health agencies were shortest (6.2 days) and those with discharge to long-term-care hospitals were longest (13.5 days), the AHRQ said in the report.
Inpatient stays with discharge to PAC made up 22.3% of all hospital discharges in 2013, with the bulk being discharges to home health agencies (50.1%) and skilled nursing facilities (40.5%). Discharges to inpatient rehabilitation facilities made up 7.2% of all PAC visits, while those to long-term-care hospitals were just 2.2%, the data from the NIS show.
Hospital costs higher for patients discharged to postacute care
The average cost of U.S. hospital stays for injury or illness in patients discharged to postacute care is more than double that of visits with routine discharges, according to the Agency for Healthcare Research and Quality.
For patients who were discharged from hospitals to PAC, the average cost of an inpatient visit in 2013 was $16,900, compared with $8,300 for patients with routine discharges. The inpatient visits with PAC were almost twice as long as those with routine discharge – 7.0 days vs. 3.6 days – and patients with PAC-discharge visits were much older – 69.5% were aged 65 years or older, compared with 22.4% of visits with routine discharges, the AHRQ reported.
The AHRQ used data from the 2013 National Inpatient Sample (NIS) to estimates discharges to PAC for all types of payers and describe these discharges from the perspective of payers, patients, hospitals, conditions/procedures, and geographic regions.
The cost of stays varied considerably among the various PAC settings in 2013. Inpatient stays with discharge to home health agencies had the lowest average cost at $15,100, with skilled nursing facilities next at $16,600, followed by inpatient rehabilitation facilities at $24,200 and long-term-care hospitals at $36,800. Length of stays by PAC setting showed the same trend: those with discharge to home health agencies were shortest (6.2 days) and those with discharge to long-term-care hospitals were longest (13.5 days), the AHRQ said in the report.
Inpatient stays with discharge to PAC made up 22.3% of all hospital discharges in 2013, with the bulk being discharges to home health agencies (50.1%) and skilled nursing facilities (40.5%). Discharges to inpatient rehabilitation facilities made up 7.2% of all PAC visits, while those to long-term-care hospitals were just 2.2%, the data from the NIS show.
The average cost of U.S. hospital stays for injury or illness in patients discharged to postacute care is more than double that of visits with routine discharges, according to the Agency for Healthcare Research and Quality.
For patients who were discharged from hospitals to PAC, the average cost of an inpatient visit in 2013 was $16,900, compared with $8,300 for patients with routine discharges. The inpatient visits with PAC were almost twice as long as those with routine discharge – 7.0 days vs. 3.6 days – and patients with PAC-discharge visits were much older – 69.5% were aged 65 years or older, compared with 22.4% of visits with routine discharges, the AHRQ reported.
The AHRQ used data from the 2013 National Inpatient Sample (NIS) to estimates discharges to PAC for all types of payers and describe these discharges from the perspective of payers, patients, hospitals, conditions/procedures, and geographic regions.
The cost of stays varied considerably among the various PAC settings in 2013. Inpatient stays with discharge to home health agencies had the lowest average cost at $15,100, with skilled nursing facilities next at $16,600, followed by inpatient rehabilitation facilities at $24,200 and long-term-care hospitals at $36,800. Length of stays by PAC setting showed the same trend: those with discharge to home health agencies were shortest (6.2 days) and those with discharge to long-term-care hospitals were longest (13.5 days), the AHRQ said in the report.
Inpatient stays with discharge to PAC made up 22.3% of all hospital discharges in 2013, with the bulk being discharges to home health agencies (50.1%) and skilled nursing facilities (40.5%). Discharges to inpatient rehabilitation facilities made up 7.2% of all PAC visits, while those to long-term-care hospitals were just 2.2%, the data from the NIS show.
The average cost of U.S. hospital stays for injury or illness in patients discharged to postacute care is more than double that of visits with routine discharges, according to the Agency for Healthcare Research and Quality.
For patients who were discharged from hospitals to PAC, the average cost of an inpatient visit in 2013 was $16,900, compared with $8,300 for patients with routine discharges. The inpatient visits with PAC were almost twice as long as those with routine discharge – 7.0 days vs. 3.6 days – and patients with PAC-discharge visits were much older – 69.5% were aged 65 years or older, compared with 22.4% of visits with routine discharges, the AHRQ reported.
The AHRQ used data from the 2013 National Inpatient Sample (NIS) to estimates discharges to PAC for all types of payers and describe these discharges from the perspective of payers, patients, hospitals, conditions/procedures, and geographic regions.
The cost of stays varied considerably among the various PAC settings in 2013. Inpatient stays with discharge to home health agencies had the lowest average cost at $15,100, with skilled nursing facilities next at $16,600, followed by inpatient rehabilitation facilities at $24,200 and long-term-care hospitals at $36,800. Length of stays by PAC setting showed the same trend: those with discharge to home health agencies were shortest (6.2 days) and those with discharge to long-term-care hospitals were longest (13.5 days), the AHRQ said in the report.
Inpatient stays with discharge to PAC made up 22.3% of all hospital discharges in 2013, with the bulk being discharges to home health agencies (50.1%) and skilled nursing facilities (40.5%). Discharges to inpatient rehabilitation facilities made up 7.2% of all PAC visits, while those to long-term-care hospitals were just 2.2%, the data from the NIS show.
Genital bumps
The FP diagnosed this patient with condyloma acuminata, also known as genital warts. The warts were well-keratinized since the patient was circumcised and the warts were not under foreskin. Genital warts found in the moist area under the foreskin of uncircumcised men tend to look more cauliflower-like.
Genital warts are caused by human papillomavirus infection, which encompasses a family of primarily sexually transmitted double-stranded DNA viruses. The incubation period after exposure ranges from 3 weeks to 8 months.
Anogenital warts are the most common viral sexually transmitted disease (STD) in the United States. There are approximately one million new cases of genital warts per year in the United States. Most infections are transient and clear up within 2 years, but some infections persist and recur, causing a great deal of distress for patients.
The diagnosis is usually clinical. Genital warts are typically asymptomatic and present as flesh-colored, exophytic lesions on the genitalia, including the penis, vulva, vagina, scrotum, perineum, and perianal skin. External warts can appear as small bumps, or they may be flat, verrucous, or pedunculated.
The FP discussed the patient’s history of unsafe sex and recommended that he receive screening for other STDs. The patient did not believe he had human immunodeficiency virus (HIV), but was willing to be tested for it and for syphilis. He denied any urethral discharge or burning on urination, but wanted to be screened for gonorrhea and chlamydia, as well. The FP ordered blood tests for syphilis and HIV and a urine screen for gonorrhea and chlamydia which were all negative.
After discussing treatment options, the patient opted to pursue cryotherapy. The FP sprayed the condyloma with liquid nitrogen using a freeze/thaw/freeze cycle and offered the patient a prescription for imiquimod cream. However, the patient preferred to return for additional cryotherapy. A follow-up appointment was set for 3 weeks.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:759-765.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP diagnosed this patient with condyloma acuminata, also known as genital warts. The warts were well-keratinized since the patient was circumcised and the warts were not under foreskin. Genital warts found in the moist area under the foreskin of uncircumcised men tend to look more cauliflower-like.
Genital warts are caused by human papillomavirus infection, which encompasses a family of primarily sexually transmitted double-stranded DNA viruses. The incubation period after exposure ranges from 3 weeks to 8 months.
Anogenital warts are the most common viral sexually transmitted disease (STD) in the United States. There are approximately one million new cases of genital warts per year in the United States. Most infections are transient and clear up within 2 years, but some infections persist and recur, causing a great deal of distress for patients.
The diagnosis is usually clinical. Genital warts are typically asymptomatic and present as flesh-colored, exophytic lesions on the genitalia, including the penis, vulva, vagina, scrotum, perineum, and perianal skin. External warts can appear as small bumps, or they may be flat, verrucous, or pedunculated.
The FP discussed the patient’s history of unsafe sex and recommended that he receive screening for other STDs. The patient did not believe he had human immunodeficiency virus (HIV), but was willing to be tested for it and for syphilis. He denied any urethral discharge or burning on urination, but wanted to be screened for gonorrhea and chlamydia, as well. The FP ordered blood tests for syphilis and HIV and a urine screen for gonorrhea and chlamydia which were all negative.
After discussing treatment options, the patient opted to pursue cryotherapy. The FP sprayed the condyloma with liquid nitrogen using a freeze/thaw/freeze cycle and offered the patient a prescription for imiquimod cream. However, the patient preferred to return for additional cryotherapy. A follow-up appointment was set for 3 weeks.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:759-765.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP diagnosed this patient with condyloma acuminata, also known as genital warts. The warts were well-keratinized since the patient was circumcised and the warts were not under foreskin. Genital warts found in the moist area under the foreskin of uncircumcised men tend to look more cauliflower-like.
Genital warts are caused by human papillomavirus infection, which encompasses a family of primarily sexually transmitted double-stranded DNA viruses. The incubation period after exposure ranges from 3 weeks to 8 months.
Anogenital warts are the most common viral sexually transmitted disease (STD) in the United States. There are approximately one million new cases of genital warts per year in the United States. Most infections are transient and clear up within 2 years, but some infections persist and recur, causing a great deal of distress for patients.
The diagnosis is usually clinical. Genital warts are typically asymptomatic and present as flesh-colored, exophytic lesions on the genitalia, including the penis, vulva, vagina, scrotum, perineum, and perianal skin. External warts can appear as small bumps, or they may be flat, verrucous, or pedunculated.
The FP discussed the patient’s history of unsafe sex and recommended that he receive screening for other STDs. The patient did not believe he had human immunodeficiency virus (HIV), but was willing to be tested for it and for syphilis. He denied any urethral discharge or burning on urination, but wanted to be screened for gonorrhea and chlamydia, as well. The FP ordered blood tests for syphilis and HIV and a urine screen for gonorrhea and chlamydia which were all negative.
After discussing treatment options, the patient opted to pursue cryotherapy. The FP sprayed the condyloma with liquid nitrogen using a freeze/thaw/freeze cycle and offered the patient a prescription for imiquimod cream. However, the patient preferred to return for additional cryotherapy. A follow-up appointment was set for 3 weeks.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:759-765.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
MPT64 rapid test may miss TB caused by M. africanum strain
Tuberculosis caused by Mycobacterium africanum West Africa 2 is significantly less likely to be detected by a MPT64 rapid antigen test than is M. tuberculosis, according to a research team based in the Gambia.
A total of 173 MGIT culture-positive sputum samples were included in the study, and the initial MPT64 test was negative in 23 samples. Just over 90% of M. tuberculosis (MTB) samples converted to positive on day 0, while only 78.4% of M. africanum West Africa 2 (MAF2) samples converted. After 10 days, 97.5% of MTB samples were positive, while conversion of MAF2 samples remained low at 84.3%.
In a comparison of the mRNA transcript from samples of six MTB and five MAF2 patients who had not been treated for TB, the MTP64 gene was about 2.5 times more abundant in the MTB samples than the MAF2 samples. No association was found between conversion to positivity and sex, age, therapy, or mycobacterial growth units.
“Given the relatively low cost, limited technical expertise, and shorter turnaround time associated with using rapid speciation tests, compared to alternative speciation methods, MPT64 rapid tests will likely remain one of the preferred options for timely diagnosis of suspected TB despite the possibility of false negative results. Therefore, a negative MPT64 result would require confirmation by an alternative method, such as molecular tests or culture on p-nitrobenzoic acid, depending on laboratory infrastructure and resources,” the investigators noted.
Read the full study in PLoS Neglected Tropical Diseases (doi:10.1371/journal.pntd.0004801).
Tuberculosis caused by Mycobacterium africanum West Africa 2 is significantly less likely to be detected by a MPT64 rapid antigen test than is M. tuberculosis, according to a research team based in the Gambia.
A total of 173 MGIT culture-positive sputum samples were included in the study, and the initial MPT64 test was negative in 23 samples. Just over 90% of M. tuberculosis (MTB) samples converted to positive on day 0, while only 78.4% of M. africanum West Africa 2 (MAF2) samples converted. After 10 days, 97.5% of MTB samples were positive, while conversion of MAF2 samples remained low at 84.3%.
In a comparison of the mRNA transcript from samples of six MTB and five MAF2 patients who had not been treated for TB, the MTP64 gene was about 2.5 times more abundant in the MTB samples than the MAF2 samples. No association was found between conversion to positivity and sex, age, therapy, or mycobacterial growth units.
“Given the relatively low cost, limited technical expertise, and shorter turnaround time associated with using rapid speciation tests, compared to alternative speciation methods, MPT64 rapid tests will likely remain one of the preferred options for timely diagnosis of suspected TB despite the possibility of false negative results. Therefore, a negative MPT64 result would require confirmation by an alternative method, such as molecular tests or culture on p-nitrobenzoic acid, depending on laboratory infrastructure and resources,” the investigators noted.
Read the full study in PLoS Neglected Tropical Diseases (doi:10.1371/journal.pntd.0004801).
Tuberculosis caused by Mycobacterium africanum West Africa 2 is significantly less likely to be detected by a MPT64 rapid antigen test than is M. tuberculosis, according to a research team based in the Gambia.
A total of 173 MGIT culture-positive sputum samples were included in the study, and the initial MPT64 test was negative in 23 samples. Just over 90% of M. tuberculosis (MTB) samples converted to positive on day 0, while only 78.4% of M. africanum West Africa 2 (MAF2) samples converted. After 10 days, 97.5% of MTB samples were positive, while conversion of MAF2 samples remained low at 84.3%.
In a comparison of the mRNA transcript from samples of six MTB and five MAF2 patients who had not been treated for TB, the MTP64 gene was about 2.5 times more abundant in the MTB samples than the MAF2 samples. No association was found between conversion to positivity and sex, age, therapy, or mycobacterial growth units.
“Given the relatively low cost, limited technical expertise, and shorter turnaround time associated with using rapid speciation tests, compared to alternative speciation methods, MPT64 rapid tests will likely remain one of the preferred options for timely diagnosis of suspected TB despite the possibility of false negative results. Therefore, a negative MPT64 result would require confirmation by an alternative method, such as molecular tests or culture on p-nitrobenzoic acid, depending on laboratory infrastructure and resources,” the investigators noted.
Read the full study in PLoS Neglected Tropical Diseases (doi:10.1371/journal.pntd.0004801).
FROM PLOS NEGLECTED TROPICAL DISEASES
MPT64 rapid test may miss TB caused by M. africanum strain
Tuberculosis caused by Mycobacterium africanum West Africa 2 is significantly less likely to be detected by a MPT64 rapid antigen test than is M. tuberculosis, according to a research team based in the Gambia.
A total of 173 MGIT culture-positive sputum samples were included in the study, and the initial MPT64 test was negative in 23 samples. Just over 90% of M. tuberculosis (MTB) samples converted to positive on day 0, while only 78.4% of M. africanum West Africa 2 (MAF2) samples converted. After 10 days, 97.5% of MTB samples were positive, while conversion of MAF2 samples remained low at 84.3%.
In a comparison of the mRNA transcript from samples of six MTB and five MAF2 patients who had not been treated for TB, the MTP64 gene was about 2.5 times more abundant in the MTB samples than the MAF2 samples. No association was found between conversion to positivity and sex, age, therapy, or mycobacterial growth units.
“Given the relatively low cost, limited technical expertise, and shorter turnaround time associated with using rapid speciation tests, compared to alternative speciation methods, MPT64 rapid tests will likely remain one of the preferred options for timely diagnosis of suspected TB despite the possibility of false negative results. Therefore, a negative MPT64 result would require confirmation by an alternative method, such as molecular tests or culture on p-nitrobenzoic acid, depending on laboratory infrastructure and resources,” the investigators noted.
Read the full study in PLoS Neglected Tropical Diseases (doi:10.1371/journal.pntd.0004801).
Tuberculosis caused by Mycobacterium africanum West Africa 2 is significantly less likely to be detected by a MPT64 rapid antigen test than is M. tuberculosis, according to a research team based in the Gambia.
A total of 173 MGIT culture-positive sputum samples were included in the study, and the initial MPT64 test was negative in 23 samples. Just over 90% of M. tuberculosis (MTB) samples converted to positive on day 0, while only 78.4% of M. africanum West Africa 2 (MAF2) samples converted. After 10 days, 97.5% of MTB samples were positive, while conversion of MAF2 samples remained low at 84.3%.
In a comparison of the mRNA transcript from samples of six MTB and five MAF2 patients who had not been treated for TB, the MTP64 gene was about 2.5 times more abundant in the MTB samples than the MAF2 samples. No association was found between conversion to positivity and sex, age, therapy, or mycobacterial growth units.
“Given the relatively low cost, limited technical expertise, and shorter turnaround time associated with using rapid speciation tests, compared to alternative speciation methods, MPT64 rapid tests will likely remain one of the preferred options for timely diagnosis of suspected TB despite the possibility of false negative results. Therefore, a negative MPT64 result would require confirmation by an alternative method, such as molecular tests or culture on p-nitrobenzoic acid, depending on laboratory infrastructure and resources,” the investigators noted.
Read the full study in PLoS Neglected Tropical Diseases (doi:10.1371/journal.pntd.0004801).
Tuberculosis caused by Mycobacterium africanum West Africa 2 is significantly less likely to be detected by a MPT64 rapid antigen test than is M. tuberculosis, according to a research team based in the Gambia.
A total of 173 MGIT culture-positive sputum samples were included in the study, and the initial MPT64 test was negative in 23 samples. Just over 90% of M. tuberculosis (MTB) samples converted to positive on day 0, while only 78.4% of M. africanum West Africa 2 (MAF2) samples converted. After 10 days, 97.5% of MTB samples were positive, while conversion of MAF2 samples remained low at 84.3%.
In a comparison of the mRNA transcript from samples of six MTB and five MAF2 patients who had not been treated for TB, the MTP64 gene was about 2.5 times more abundant in the MTB samples than the MAF2 samples. No association was found between conversion to positivity and sex, age, therapy, or mycobacterial growth units.
“Given the relatively low cost, limited technical expertise, and shorter turnaround time associated with using rapid speciation tests, compared to alternative speciation methods, MPT64 rapid tests will likely remain one of the preferred options for timely diagnosis of suspected TB despite the possibility of false negative results. Therefore, a negative MPT64 result would require confirmation by an alternative method, such as molecular tests or culture on p-nitrobenzoic acid, depending on laboratory infrastructure and resources,” the investigators noted.
Read the full study in PLoS Neglected Tropical Diseases (doi:10.1371/journal.pntd.0004801).
FROM PLOS NEGLECTED TROPICAL DISEASES
