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Questions plague platelet-rich plasma’s promise
NEW YORK – If platelet-rich plasma is good enough for Kim Kardashian, what more do you need to know?
Turns out, there’s plenty to know, and plenty more that remains unknown about the procedure, which is sometimes referred to as PRP or, in Kardashian’s case, as a “vampire facial,” according to Terrence Keaney, MD, of the department of dermatology, George Washington University, Washington.
It’s easy to make: draw blood, centrifuge it, and then deliver it. The platelets themselves are not the active substances. For that, you have to look at what the platelets release from their alpha granules. They include a wealth of growth factors, including platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, epidermal growth factor, fibroblast growth factor, and connective tissue growth factor.
That’s not all. “There are 800 other bioactive molecules secreted by platelets,” including cell adhesion molecules, cytokines, antimicrobial peptides, and anti-inflammatory molecules, said Dr. Keaney, founder and director of SkinDC, in Arlington, Va. “You bring it all together, what is PRP? A growth factor/cytokine cocktail.”
But, like the cocktails one can find in a college dorm, compared with the ones found at a bar at an upscale hotel, there can be big differences – depending on who’s doing the mixing.
Still, its reputation as an all-natural, safe product has made it appealing to the public, as well as to doctors in fields beyond dermatology, he said, citing sports medicine, dentistry, otolaryngology, ophthalmology, urology, wound healing, cosmetic medicine, and cardiothoracic and maxillofacial medicine.
The Food and Drug Administration considers it a blood product, which means that it is exempt from the FDA’s traditional regulatory pathways, which would require animal studies and clinical trials. Instead, oversight falls to the FDA’s Center for Biologics Evaluation and Research, which is responsible for regulating human cells, tissues, and cellular- and tissue-based products.
A number of device makers have used the 510(k) application to bring PRP preparation systems to market. Under the application, devices that are “substantially equivalent” to a currently marketed device gain FDA clearance (J Knee Surg. 2015 Feb;28[1]:29-34). The result is that many such systems are available.
Nearly all of the devices have received clearance to produce PRP for use with bone graft materials in platelet-rich products for use by orthopedic surgeons. Other uses of the product, like stimulating hair growth, would be considered off-label.
Nevertheless, the purveyors of PRP have found people willing to part with their money in exchange for the hope that they may be able to hold on to their hair. That is not surprising, given the “pretty meager” therapeutic armamentarium available to them, Dr. Keaney said, citing minoxidil and finasteride – each of which was approved more than 20 years ago.
He bemoaned the lack of standardization for everything from platelet preparation technique to potential applications, which include facial rejuvenation, wound healing, and hair loss. “PRP has hype and it has hope, but it needs help,” he said. “There are lots of clinical questions that need to be answered.”
He added that the data remain thin. “Unfortunately, our clinical data does not match the hype around PRP,” he said, citing a recently published meta-analysis of six studies involving 177 patients (J Cosmet Dermatol. 2017 Mar 13. doi: 10.1111/jocd.12331).
Its conclusion was measured: “Platelet-rich plasma injection for local hair restoration in patients with androgenetic alopecia seems to increase hair’s number and thickness with minimal or no collateral effects. However, the current evidence does not support this treatment’s modality over hair transplantation due to the lack of established protocols,” the authors wrote. The meta-analysis results, they added, “should be interpreted with caution because it consists of pooling many small studies and larger randomized studies should be performed to verify this perception.”
Questions include how to determine the proper concentration and how many times PRP should be centrifuged, Dr. Keaney said. And it is not clear how or how often to deliver PRP. Subdermally? Via microneedle? Both? After traumatizing the skin to increase endogenous activators? Daily? Weekly? Monthly?
“We don’t know,” he said.
And, Dr. Keaney acknowledged, that may not change. “There is little incentive for industry to do a large-scale study,” he said. “If the results aren’t what they look for then you’ve killed your golden goose.”
Still, he has not been dissuaded. “From my standpoint, there’s a good scientific rationale, a proposed mechanism of action, molecular pathways.”
Though the clinical data have been variable, the studies small, and the study designs inconsistent, “there is a trend towards clinical effect,” he said. “If this is done appropriately, using appropriate systems and protocols in your office, this can be a very safe procedure – with injection site discomfort,” he said.
Dr. Keaney has spoken on behalf of a PRP preparation manufacturer.
[email protected]
NEW YORK – If platelet-rich plasma is good enough for Kim Kardashian, what more do you need to know?
Turns out, there’s plenty to know, and plenty more that remains unknown about the procedure, which is sometimes referred to as PRP or, in Kardashian’s case, as a “vampire facial,” according to Terrence Keaney, MD, of the department of dermatology, George Washington University, Washington.
It’s easy to make: draw blood, centrifuge it, and then deliver it. The platelets themselves are not the active substances. For that, you have to look at what the platelets release from their alpha granules. They include a wealth of growth factors, including platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, epidermal growth factor, fibroblast growth factor, and connective tissue growth factor.
That’s not all. “There are 800 other bioactive molecules secreted by platelets,” including cell adhesion molecules, cytokines, antimicrobial peptides, and anti-inflammatory molecules, said Dr. Keaney, founder and director of SkinDC, in Arlington, Va. “You bring it all together, what is PRP? A growth factor/cytokine cocktail.”
But, like the cocktails one can find in a college dorm, compared with the ones found at a bar at an upscale hotel, there can be big differences – depending on who’s doing the mixing.
Still, its reputation as an all-natural, safe product has made it appealing to the public, as well as to doctors in fields beyond dermatology, he said, citing sports medicine, dentistry, otolaryngology, ophthalmology, urology, wound healing, cosmetic medicine, and cardiothoracic and maxillofacial medicine.
The Food and Drug Administration considers it a blood product, which means that it is exempt from the FDA’s traditional regulatory pathways, which would require animal studies and clinical trials. Instead, oversight falls to the FDA’s Center for Biologics Evaluation and Research, which is responsible for regulating human cells, tissues, and cellular- and tissue-based products.
A number of device makers have used the 510(k) application to bring PRP preparation systems to market. Under the application, devices that are “substantially equivalent” to a currently marketed device gain FDA clearance (J Knee Surg. 2015 Feb;28[1]:29-34). The result is that many such systems are available.
Nearly all of the devices have received clearance to produce PRP for use with bone graft materials in platelet-rich products for use by orthopedic surgeons. Other uses of the product, like stimulating hair growth, would be considered off-label.
Nevertheless, the purveyors of PRP have found people willing to part with their money in exchange for the hope that they may be able to hold on to their hair. That is not surprising, given the “pretty meager” therapeutic armamentarium available to them, Dr. Keaney said, citing minoxidil and finasteride – each of which was approved more than 20 years ago.
He bemoaned the lack of standardization for everything from platelet preparation technique to potential applications, which include facial rejuvenation, wound healing, and hair loss. “PRP has hype and it has hope, but it needs help,” he said. “There are lots of clinical questions that need to be answered.”
He added that the data remain thin. “Unfortunately, our clinical data does not match the hype around PRP,” he said, citing a recently published meta-analysis of six studies involving 177 patients (J Cosmet Dermatol. 2017 Mar 13. doi: 10.1111/jocd.12331).
Its conclusion was measured: “Platelet-rich plasma injection for local hair restoration in patients with androgenetic alopecia seems to increase hair’s number and thickness with minimal or no collateral effects. However, the current evidence does not support this treatment’s modality over hair transplantation due to the lack of established protocols,” the authors wrote. The meta-analysis results, they added, “should be interpreted with caution because it consists of pooling many small studies and larger randomized studies should be performed to verify this perception.”
Questions include how to determine the proper concentration and how many times PRP should be centrifuged, Dr. Keaney said. And it is not clear how or how often to deliver PRP. Subdermally? Via microneedle? Both? After traumatizing the skin to increase endogenous activators? Daily? Weekly? Monthly?
“We don’t know,” he said.
And, Dr. Keaney acknowledged, that may not change. “There is little incentive for industry to do a large-scale study,” he said. “If the results aren’t what they look for then you’ve killed your golden goose.”
Still, he has not been dissuaded. “From my standpoint, there’s a good scientific rationale, a proposed mechanism of action, molecular pathways.”
Though the clinical data have been variable, the studies small, and the study designs inconsistent, “there is a trend towards clinical effect,” he said. “If this is done appropriately, using appropriate systems and protocols in your office, this can be a very safe procedure – with injection site discomfort,” he said.
Dr. Keaney has spoken on behalf of a PRP preparation manufacturer.
[email protected]
NEW YORK – If platelet-rich plasma is good enough for Kim Kardashian, what more do you need to know?
Turns out, there’s plenty to know, and plenty more that remains unknown about the procedure, which is sometimes referred to as PRP or, in Kardashian’s case, as a “vampire facial,” according to Terrence Keaney, MD, of the department of dermatology, George Washington University, Washington.
It’s easy to make: draw blood, centrifuge it, and then deliver it. The platelets themselves are not the active substances. For that, you have to look at what the platelets release from their alpha granules. They include a wealth of growth factors, including platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, epidermal growth factor, fibroblast growth factor, and connective tissue growth factor.
That’s not all. “There are 800 other bioactive molecules secreted by platelets,” including cell adhesion molecules, cytokines, antimicrobial peptides, and anti-inflammatory molecules, said Dr. Keaney, founder and director of SkinDC, in Arlington, Va. “You bring it all together, what is PRP? A growth factor/cytokine cocktail.”
But, like the cocktails one can find in a college dorm, compared with the ones found at a bar at an upscale hotel, there can be big differences – depending on who’s doing the mixing.
Still, its reputation as an all-natural, safe product has made it appealing to the public, as well as to doctors in fields beyond dermatology, he said, citing sports medicine, dentistry, otolaryngology, ophthalmology, urology, wound healing, cosmetic medicine, and cardiothoracic and maxillofacial medicine.
The Food and Drug Administration considers it a blood product, which means that it is exempt from the FDA’s traditional regulatory pathways, which would require animal studies and clinical trials. Instead, oversight falls to the FDA’s Center for Biologics Evaluation and Research, which is responsible for regulating human cells, tissues, and cellular- and tissue-based products.
A number of device makers have used the 510(k) application to bring PRP preparation systems to market. Under the application, devices that are “substantially equivalent” to a currently marketed device gain FDA clearance (J Knee Surg. 2015 Feb;28[1]:29-34). The result is that many such systems are available.
Nearly all of the devices have received clearance to produce PRP for use with bone graft materials in platelet-rich products for use by orthopedic surgeons. Other uses of the product, like stimulating hair growth, would be considered off-label.
Nevertheless, the purveyors of PRP have found people willing to part with their money in exchange for the hope that they may be able to hold on to their hair. That is not surprising, given the “pretty meager” therapeutic armamentarium available to them, Dr. Keaney said, citing minoxidil and finasteride – each of which was approved more than 20 years ago.
He bemoaned the lack of standardization for everything from platelet preparation technique to potential applications, which include facial rejuvenation, wound healing, and hair loss. “PRP has hype and it has hope, but it needs help,” he said. “There are lots of clinical questions that need to be answered.”
He added that the data remain thin. “Unfortunately, our clinical data does not match the hype around PRP,” he said, citing a recently published meta-analysis of six studies involving 177 patients (J Cosmet Dermatol. 2017 Mar 13. doi: 10.1111/jocd.12331).
Its conclusion was measured: “Platelet-rich plasma injection for local hair restoration in patients with androgenetic alopecia seems to increase hair’s number and thickness with minimal or no collateral effects. However, the current evidence does not support this treatment’s modality over hair transplantation due to the lack of established protocols,” the authors wrote. The meta-analysis results, they added, “should be interpreted with caution because it consists of pooling many small studies and larger randomized studies should be performed to verify this perception.”
Questions include how to determine the proper concentration and how many times PRP should be centrifuged, Dr. Keaney said. And it is not clear how or how often to deliver PRP. Subdermally? Via microneedle? Both? After traumatizing the skin to increase endogenous activators? Daily? Weekly? Monthly?
“We don’t know,” he said.
And, Dr. Keaney acknowledged, that may not change. “There is little incentive for industry to do a large-scale study,” he said. “If the results aren’t what they look for then you’ve killed your golden goose.”
Still, he has not been dissuaded. “From my standpoint, there’s a good scientific rationale, a proposed mechanism of action, molecular pathways.”
Though the clinical data have been variable, the studies small, and the study designs inconsistent, “there is a trend towards clinical effect,” he said. “If this is done appropriately, using appropriate systems and protocols in your office, this can be a very safe procedure – with injection site discomfort,” he said.
Dr. Keaney has spoken on behalf of a PRP preparation manufacturer.
[email protected]
AT THE 2017 AAD SUMMER MEETING
Test everyone with diagnosed HIV for drug resistance as they enter care
Antiretroviral therapy (ART) for HIV is critical for achieving viral suppression, which improves the health and longevity of people living with infection and dramatically reduces the risk of transmitting HIV to others. Despite these clear benefits, not everyone prescribed ART adheres to their medications, which can result in drug resistance – and transmission of drug-resistant HIV to others.
A Centers for Disease Control and Prevention analysis of eight U.S. cities found that more than 18 percent of 13,393 people with a recent HIV diagnosis had infections that were resistant to at least one form of treatment. Since 2007, the U.S. Department of Health & Human Services has recommended that everyone with diagnosed HIV infection be tested for drug resistance when HIV care begins; however, it’s not known how closely HIV care providers in the United States follow the guidelines.
To learn more, the CDC recently analyzed HIV surveillance data to examine testing patterns among people living with diagnosed HIV who had entered HIV medical care. The results of the study, published in AIDS Care (2017 May. doi: 10.1080/09540121.2017.1316356), indicated that, of the people with HIV diagnosed in 2013 who had entered medical care, only 66% had been tested for resistance. Of those tested, 68% received testing at the beginning of care.
The findings also show that resistance testing is performed less often among certain groups, including males who inject drugs. In recent reports, about a third of people who inject drugs in selected U.S. cities indicated they did not have health insurance, and nearly 80% lived at or below the federal poverty level. Lack of health care access and low socioeconomic status may be potential barriers to receiving medical care and laboratory testing. Additionally, this population might not be aware of available resources that support these services, including those provided through the Ryan White HIV/AIDS Program and federally qualified health centers.
Previous research has also shown that non-HIV specialists are less likely than HIV specialists to order resistance testing for their patients. With potentially more injection drug use and fewer specialist health care services available in less-populated communities, there is an urgent need both to improve HIV testing and increase resistance testing in rural communities. This is important given the growing potential for HIV outbreaks among people who inject drugs, as well as the substantial rise in the number of deaths attributed to opioid use in many communities throughout the nation.
The study findings also indicate that resistance testing is less common among people with higher CD4 counts in some states, including Michigan, New York, and Texas. CD4 cells are a type of white blood cell that helps in protecting the body from infections, but they are also targeted by HIV. CD4 cell counts can be used to determine the stage of HIV infection in a person. As HIV stays in the body longer, CD4 cells decrease. Even if treatment is delayed for a medical reason, such as coinfection with tuberculosis, resistance testing should still be conducted at a person’s entry to care to help ensure treatment success later.
These results have strong implications for clinical practice and management of people with newly diagnosed HIV. More research is needed to identify the factors influencing lacking or delayed resistance testing so that we can address differences in the development of resistance, as well as other clinical outcomes, over time.
Antiretroviral therapy (ART) for HIV is critical for achieving viral suppression, which improves the health and longevity of people living with infection and dramatically reduces the risk of transmitting HIV to others. Despite these clear benefits, not everyone prescribed ART adheres to their medications, which can result in drug resistance – and transmission of drug-resistant HIV to others.
A Centers for Disease Control and Prevention analysis of eight U.S. cities found that more than 18 percent of 13,393 people with a recent HIV diagnosis had infections that were resistant to at least one form of treatment. Since 2007, the U.S. Department of Health & Human Services has recommended that everyone with diagnosed HIV infection be tested for drug resistance when HIV care begins; however, it’s not known how closely HIV care providers in the United States follow the guidelines.
To learn more, the CDC recently analyzed HIV surveillance data to examine testing patterns among people living with diagnosed HIV who had entered HIV medical care. The results of the study, published in AIDS Care (2017 May. doi: 10.1080/09540121.2017.1316356), indicated that, of the people with HIV diagnosed in 2013 who had entered medical care, only 66% had been tested for resistance. Of those tested, 68% received testing at the beginning of care.
The findings also show that resistance testing is performed less often among certain groups, including males who inject drugs. In recent reports, about a third of people who inject drugs in selected U.S. cities indicated they did not have health insurance, and nearly 80% lived at or below the federal poverty level. Lack of health care access and low socioeconomic status may be potential barriers to receiving medical care and laboratory testing. Additionally, this population might not be aware of available resources that support these services, including those provided through the Ryan White HIV/AIDS Program and federally qualified health centers.
Previous research has also shown that non-HIV specialists are less likely than HIV specialists to order resistance testing for their patients. With potentially more injection drug use and fewer specialist health care services available in less-populated communities, there is an urgent need both to improve HIV testing and increase resistance testing in rural communities. This is important given the growing potential for HIV outbreaks among people who inject drugs, as well as the substantial rise in the number of deaths attributed to opioid use in many communities throughout the nation.
The study findings also indicate that resistance testing is less common among people with higher CD4 counts in some states, including Michigan, New York, and Texas. CD4 cells are a type of white blood cell that helps in protecting the body from infections, but they are also targeted by HIV. CD4 cell counts can be used to determine the stage of HIV infection in a person. As HIV stays in the body longer, CD4 cells decrease. Even if treatment is delayed for a medical reason, such as coinfection with tuberculosis, resistance testing should still be conducted at a person’s entry to care to help ensure treatment success later.
These results have strong implications for clinical practice and management of people with newly diagnosed HIV. More research is needed to identify the factors influencing lacking or delayed resistance testing so that we can address differences in the development of resistance, as well as other clinical outcomes, over time.
Antiretroviral therapy (ART) for HIV is critical for achieving viral suppression, which improves the health and longevity of people living with infection and dramatically reduces the risk of transmitting HIV to others. Despite these clear benefits, not everyone prescribed ART adheres to their medications, which can result in drug resistance – and transmission of drug-resistant HIV to others.
A Centers for Disease Control and Prevention analysis of eight U.S. cities found that more than 18 percent of 13,393 people with a recent HIV diagnosis had infections that were resistant to at least one form of treatment. Since 2007, the U.S. Department of Health & Human Services has recommended that everyone with diagnosed HIV infection be tested for drug resistance when HIV care begins; however, it’s not known how closely HIV care providers in the United States follow the guidelines.
To learn more, the CDC recently analyzed HIV surveillance data to examine testing patterns among people living with diagnosed HIV who had entered HIV medical care. The results of the study, published in AIDS Care (2017 May. doi: 10.1080/09540121.2017.1316356), indicated that, of the people with HIV diagnosed in 2013 who had entered medical care, only 66% had been tested for resistance. Of those tested, 68% received testing at the beginning of care.
The findings also show that resistance testing is performed less often among certain groups, including males who inject drugs. In recent reports, about a third of people who inject drugs in selected U.S. cities indicated they did not have health insurance, and nearly 80% lived at or below the federal poverty level. Lack of health care access and low socioeconomic status may be potential barriers to receiving medical care and laboratory testing. Additionally, this population might not be aware of available resources that support these services, including those provided through the Ryan White HIV/AIDS Program and federally qualified health centers.
Previous research has also shown that non-HIV specialists are less likely than HIV specialists to order resistance testing for their patients. With potentially more injection drug use and fewer specialist health care services available in less-populated communities, there is an urgent need both to improve HIV testing and increase resistance testing in rural communities. This is important given the growing potential for HIV outbreaks among people who inject drugs, as well as the substantial rise in the number of deaths attributed to opioid use in many communities throughout the nation.
The study findings also indicate that resistance testing is less common among people with higher CD4 counts in some states, including Michigan, New York, and Texas. CD4 cells are a type of white blood cell that helps in protecting the body from infections, but they are also targeted by HIV. CD4 cell counts can be used to determine the stage of HIV infection in a person. As HIV stays in the body longer, CD4 cells decrease. Even if treatment is delayed for a medical reason, such as coinfection with tuberculosis, resistance testing should still be conducted at a person’s entry to care to help ensure treatment success later.
These results have strong implications for clinical practice and management of people with newly diagnosed HIV. More research is needed to identify the factors influencing lacking or delayed resistance testing so that we can address differences in the development of resistance, as well as other clinical outcomes, over time.
Liraglutide approved for cardiovascular event reduction
The type 2 diabetes treatment Victoza (liraglutide) has been approved by the Food and Drug Administration for a new indication – to reduce the risk of several adverse cardiovascular events, according to a press release from Novo Nordisk.
FDA approval was based on results from the LEADER (NCT01179048) trial, where people with type 2 diabetes who received liraglutide were 13% less likely to experience cardiovascular death, nonfatal heart attack, or nonfatal stroke then type 2 diabetes patients who received a placebo, with an absolute risk reduction of 1.9%. Notably, risk of cardiovascular death was reduced by 22% in the liraglutide group, compared with the control group, and all-cause death was reduced by 15%.
“Today’s news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events. More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue,” Steve Marso, MD, medical director at the Cardiovascular Services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER said in the press release.
Find the full press release on the Novo Nordisk website.
The type 2 diabetes treatment Victoza (liraglutide) has been approved by the Food and Drug Administration for a new indication – to reduce the risk of several adverse cardiovascular events, according to a press release from Novo Nordisk.
FDA approval was based on results from the LEADER (NCT01179048) trial, where people with type 2 diabetes who received liraglutide were 13% less likely to experience cardiovascular death, nonfatal heart attack, or nonfatal stroke then type 2 diabetes patients who received a placebo, with an absolute risk reduction of 1.9%. Notably, risk of cardiovascular death was reduced by 22% in the liraglutide group, compared with the control group, and all-cause death was reduced by 15%.
“Today’s news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events. More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue,” Steve Marso, MD, medical director at the Cardiovascular Services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER said in the press release.
Find the full press release on the Novo Nordisk website.
The type 2 diabetes treatment Victoza (liraglutide) has been approved by the Food and Drug Administration for a new indication – to reduce the risk of several adverse cardiovascular events, according to a press release from Novo Nordisk.
FDA approval was based on results from the LEADER (NCT01179048) trial, where people with type 2 diabetes who received liraglutide were 13% less likely to experience cardiovascular death, nonfatal heart attack, or nonfatal stroke then type 2 diabetes patients who received a placebo, with an absolute risk reduction of 1.9%. Notably, risk of cardiovascular death was reduced by 22% in the liraglutide group, compared with the control group, and all-cause death was reduced by 15%.
“Today’s news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events. More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue,” Steve Marso, MD, medical director at the Cardiovascular Services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER said in the press release.
Find the full press release on the Novo Nordisk website.
FDA approves once-daily treatment for hyperuricemia in gout
The Food and Drug Administration announced Aug. 21 the approval of Duzallo, a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.
Duzallo is a fixed-dose combination of lesinurad 200 mg and allopurinol 300 mg that will be marketed by Ironwood Pharmaceuticals. It will also be available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood in an announcement from the company.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for gout, lesinurad (Zurampic). Allopurinol is an xanthine oxidase inhibitor whose action differs from that of uricosuric agents such as lesinurad. Allopurinol reduces the production of uric acid, whereas lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the uric acid transporter responsible for the majority of renal uric acid reabsorption.
Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. It has a boxed warning regarding the risk of acute renal failure.
Duzallo is expected to be commercially available early in the fourth quarter of 2017.
The Food and Drug Administration announced Aug. 21 the approval of Duzallo, a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.
Duzallo is a fixed-dose combination of lesinurad 200 mg and allopurinol 300 mg that will be marketed by Ironwood Pharmaceuticals. It will also be available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood in an announcement from the company.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for gout, lesinurad (Zurampic). Allopurinol is an xanthine oxidase inhibitor whose action differs from that of uricosuric agents such as lesinurad. Allopurinol reduces the production of uric acid, whereas lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the uric acid transporter responsible for the majority of renal uric acid reabsorption.
Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. It has a boxed warning regarding the risk of acute renal failure.
Duzallo is expected to be commercially available early in the fourth quarter of 2017.
The Food and Drug Administration announced Aug. 21 the approval of Duzallo, a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.
Duzallo is a fixed-dose combination of lesinurad 200 mg and allopurinol 300 mg that will be marketed by Ironwood Pharmaceuticals. It will also be available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood in an announcement from the company.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for gout, lesinurad (Zurampic). Allopurinol is an xanthine oxidase inhibitor whose action differs from that of uricosuric agents such as lesinurad. Allopurinol reduces the production of uric acid, whereas lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the uric acid transporter responsible for the majority of renal uric acid reabsorption.
Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. It has a boxed warning regarding the risk of acute renal failure.
Duzallo is expected to be commercially available early in the fourth quarter of 2017.
Headache May Be Independent of Idiopathic Intracranial Hypertension
Headache in idiopathic intracranial hypertension (IIH) appears to be clinically independent of raised intracranial pressure and may require a different treatment approach than lowering intracranial pressure, according to a study published online ahead of print July 28 in Headache.
The researchers examined data from 165 patients with untreated IIH and mild vision loss. The participants had been randomized to weight loss plus acetazolamide or placebo as a part of the IIH Treatment Trial.
In the 139 patients with headaches at baseline, the researchers saw no significant correlation between lumbar puncture opening pressure, which was measured at baseline and six months, and Headache Impact Test-6 (HIT-6) scores, or with the presence or absence of headache.
The researchers found no significant difference in headache outcomes between the acetazolamide and placebo groups at six months. Headaches in both groups improved overall during the course of the study, however.
At baseline, participants with headache reported taking various symptomatic headache treatments, including acetaminophen, ibuprofen, naproxen, and combination medications. Some also reported taking hydrocodone, tramadol, or combination formulations containing codeine.
Approximately 37% of the participants overused symptomatic pain medication. Fifteen of these patients met the criteria for overuse of opioids or combination medications. The mean HIT-6 scores were significantly higher in those who were overusing medications, compared with those who were not.
The most common headache phenotype was migraine (52%), followed by tension-type headache (22%), probable migraine (16%), and probable tension-type headache (4%), with 7% unclassified. Patients with headache also experienced associated symptoms such as photophobia, phonophobia, nausea, vomiting, visual loss or obscurations, diplopia, and dizziness.
—Bianca Nogrady
Suggested Reading
Friedman DI, Quiros PA, Subramanian PS, et al. Headache in idiopathic intracranial hypertension: Findings from the Idiopathic Intracranial Hypertension Treatment Trial. Headache. 2017 July 28 [Epub ahead of print].
Yri HM, Rönnbäck C, Wegener M, et al. The course of headache in idiopathic intracranial hypertension: a 12-month prospective follow-up study. Eur J Neurol. 2014;21(12):1458-1464.
Headache in idiopathic intracranial hypertension (IIH) appears to be clinically independent of raised intracranial pressure and may require a different treatment approach than lowering intracranial pressure, according to a study published online ahead of print July 28 in Headache.
The researchers examined data from 165 patients with untreated IIH and mild vision loss. The participants had been randomized to weight loss plus acetazolamide or placebo as a part of the IIH Treatment Trial.
In the 139 patients with headaches at baseline, the researchers saw no significant correlation between lumbar puncture opening pressure, which was measured at baseline and six months, and Headache Impact Test-6 (HIT-6) scores, or with the presence or absence of headache.
The researchers found no significant difference in headache outcomes between the acetazolamide and placebo groups at six months. Headaches in both groups improved overall during the course of the study, however.
At baseline, participants with headache reported taking various symptomatic headache treatments, including acetaminophen, ibuprofen, naproxen, and combination medications. Some also reported taking hydrocodone, tramadol, or combination formulations containing codeine.
Approximately 37% of the participants overused symptomatic pain medication. Fifteen of these patients met the criteria for overuse of opioids or combination medications. The mean HIT-6 scores were significantly higher in those who were overusing medications, compared with those who were not.
The most common headache phenotype was migraine (52%), followed by tension-type headache (22%), probable migraine (16%), and probable tension-type headache (4%), with 7% unclassified. Patients with headache also experienced associated symptoms such as photophobia, phonophobia, nausea, vomiting, visual loss or obscurations, diplopia, and dizziness.
—Bianca Nogrady
Suggested Reading
Friedman DI, Quiros PA, Subramanian PS, et al. Headache in idiopathic intracranial hypertension: Findings from the Idiopathic Intracranial Hypertension Treatment Trial. Headache. 2017 July 28 [Epub ahead of print].
Yri HM, Rönnbäck C, Wegener M, et al. The course of headache in idiopathic intracranial hypertension: a 12-month prospective follow-up study. Eur J Neurol. 2014;21(12):1458-1464.
Headache in idiopathic intracranial hypertension (IIH) appears to be clinically independent of raised intracranial pressure and may require a different treatment approach than lowering intracranial pressure, according to a study published online ahead of print July 28 in Headache.
The researchers examined data from 165 patients with untreated IIH and mild vision loss. The participants had been randomized to weight loss plus acetazolamide or placebo as a part of the IIH Treatment Trial.
In the 139 patients with headaches at baseline, the researchers saw no significant correlation between lumbar puncture opening pressure, which was measured at baseline and six months, and Headache Impact Test-6 (HIT-6) scores, or with the presence or absence of headache.
The researchers found no significant difference in headache outcomes between the acetazolamide and placebo groups at six months. Headaches in both groups improved overall during the course of the study, however.
At baseline, participants with headache reported taking various symptomatic headache treatments, including acetaminophen, ibuprofen, naproxen, and combination medications. Some also reported taking hydrocodone, tramadol, or combination formulations containing codeine.
Approximately 37% of the participants overused symptomatic pain medication. Fifteen of these patients met the criteria for overuse of opioids or combination medications. The mean HIT-6 scores were significantly higher in those who were overusing medications, compared with those who were not.
The most common headache phenotype was migraine (52%), followed by tension-type headache (22%), probable migraine (16%), and probable tension-type headache (4%), with 7% unclassified. Patients with headache also experienced associated symptoms such as photophobia, phonophobia, nausea, vomiting, visual loss or obscurations, diplopia, and dizziness.
—Bianca Nogrady
Suggested Reading
Friedman DI, Quiros PA, Subramanian PS, et al. Headache in idiopathic intracranial hypertension: Findings from the Idiopathic Intracranial Hypertension Treatment Trial. Headache. 2017 July 28 [Epub ahead of print].
Yri HM, Rönnbäck C, Wegener M, et al. The course of headache in idiopathic intracranial hypertension: a 12-month prospective follow-up study. Eur J Neurol. 2014;21(12):1458-1464.
Extended-release amantadine approved for treatment of dyskinesia in Parkinson’s
An extended-release formulation of amantadine received approval from the Food and Drug Administration on Aug. 24 for the treatment of dyskinesia in patients with Parkinson’s disease. The significant increase in functional time for Parkinson’s disease patients with dyskinesia who took extended-release amantadine was attributable both to a reduction in off-time and to a decrease in troublesome dyskinesia during on-time.
This is the first FDA approval for a drug to treat levodopa therapy-related dyskinesia in patients with Parkinson’s disease, according to an announcement from its manufacturer, Adamas Pharmaceuticals.
The second study also showed clinically relevant and statistically significant results, with a 46% reduction on the UDysRS for those taking ER amantadine, compared with a 16% reduction for those taking placebo.
The oral ER amantadine formulation delivers 274 mg of amantadine once daily at bedtime, allowing sustained high levels of the drug during waking hours, with peak levels delivered during the morning and throughout the day and a trough near bedtime.
When investigators of the two studies analyzed diaries that had been kept by Parkinson’s disease patients, they found that patients in the two studies who were taking ER amantadine experienced a placebo-adjusted reduction in off-time of about 1 hour per day.
Patients in the ER amantadine arm of the first study also had an increase of 3.6 hours per day of functional time, compared with a 0.8-hour increase for patients taking placebo. In the second study, functional time went up by 4.0 hours per day for patients in the ER amantadine arm, compared with an increase of 2.1 hours per day for those on placebo. Functional time was defined as on-time without troublesome dyskinesia.
Adverse reactions to ER amantadine that occurred in more than 10% of patients in the active arms of the study, and which occurred more frequently than in those taking placebo, included hallucinations, falls, orthostatic hypotension, dizziness, peripheral edema, dry mouth, and constipation.
The medication is contraindicated in those with creatinine clearance below 15 mL/min/1.73 m2. Prescribing information advises that amantadine ER be avoided or used with caution in patients with a history of suicidality and depression, hallucinations or psychotic behavior, and orthostatic hypotension or dizziness.
Patients taking ER amantadine may also experience impulsivity and sexual, spending, or gambling urges. Abrupt withdrawal or rapid dose reduction may result in withdrawal-emergent hyperpyrexia or confusion, including delirium, hallucinations, stupor, and slurred speech.
The clinical trials upon which the approval is based were funded by Adamas Pharmaceuticals.
[email protected]
On Twitter @karioakes
An extended-release formulation of amantadine received approval from the Food and Drug Administration on Aug. 24 for the treatment of dyskinesia in patients with Parkinson’s disease. The significant increase in functional time for Parkinson’s disease patients with dyskinesia who took extended-release amantadine was attributable both to a reduction in off-time and to a decrease in troublesome dyskinesia during on-time.
This is the first FDA approval for a drug to treat levodopa therapy-related dyskinesia in patients with Parkinson’s disease, according to an announcement from its manufacturer, Adamas Pharmaceuticals.
The second study also showed clinically relevant and statistically significant results, with a 46% reduction on the UDysRS for those taking ER amantadine, compared with a 16% reduction for those taking placebo.
The oral ER amantadine formulation delivers 274 mg of amantadine once daily at bedtime, allowing sustained high levels of the drug during waking hours, with peak levels delivered during the morning and throughout the day and a trough near bedtime.
When investigators of the two studies analyzed diaries that had been kept by Parkinson’s disease patients, they found that patients in the two studies who were taking ER amantadine experienced a placebo-adjusted reduction in off-time of about 1 hour per day.
Patients in the ER amantadine arm of the first study also had an increase of 3.6 hours per day of functional time, compared with a 0.8-hour increase for patients taking placebo. In the second study, functional time went up by 4.0 hours per day for patients in the ER amantadine arm, compared with an increase of 2.1 hours per day for those on placebo. Functional time was defined as on-time without troublesome dyskinesia.
Adverse reactions to ER amantadine that occurred in more than 10% of patients in the active arms of the study, and which occurred more frequently than in those taking placebo, included hallucinations, falls, orthostatic hypotension, dizziness, peripheral edema, dry mouth, and constipation.
The medication is contraindicated in those with creatinine clearance below 15 mL/min/1.73 m2. Prescribing information advises that amantadine ER be avoided or used with caution in patients with a history of suicidality and depression, hallucinations or psychotic behavior, and orthostatic hypotension or dizziness.
Patients taking ER amantadine may also experience impulsivity and sexual, spending, or gambling urges. Abrupt withdrawal or rapid dose reduction may result in withdrawal-emergent hyperpyrexia or confusion, including delirium, hallucinations, stupor, and slurred speech.
The clinical trials upon which the approval is based were funded by Adamas Pharmaceuticals.
[email protected]
On Twitter @karioakes
An extended-release formulation of amantadine received approval from the Food and Drug Administration on Aug. 24 for the treatment of dyskinesia in patients with Parkinson’s disease. The significant increase in functional time for Parkinson’s disease patients with dyskinesia who took extended-release amantadine was attributable both to a reduction in off-time and to a decrease in troublesome dyskinesia during on-time.
This is the first FDA approval for a drug to treat levodopa therapy-related dyskinesia in patients with Parkinson’s disease, according to an announcement from its manufacturer, Adamas Pharmaceuticals.
The second study also showed clinically relevant and statistically significant results, with a 46% reduction on the UDysRS for those taking ER amantadine, compared with a 16% reduction for those taking placebo.
The oral ER amantadine formulation delivers 274 mg of amantadine once daily at bedtime, allowing sustained high levels of the drug during waking hours, with peak levels delivered during the morning and throughout the day and a trough near bedtime.
When investigators of the two studies analyzed diaries that had been kept by Parkinson’s disease patients, they found that patients in the two studies who were taking ER amantadine experienced a placebo-adjusted reduction in off-time of about 1 hour per day.
Patients in the ER amantadine arm of the first study also had an increase of 3.6 hours per day of functional time, compared with a 0.8-hour increase for patients taking placebo. In the second study, functional time went up by 4.0 hours per day for patients in the ER amantadine arm, compared with an increase of 2.1 hours per day for those on placebo. Functional time was defined as on-time without troublesome dyskinesia.
Adverse reactions to ER amantadine that occurred in more than 10% of patients in the active arms of the study, and which occurred more frequently than in those taking placebo, included hallucinations, falls, orthostatic hypotension, dizziness, peripheral edema, dry mouth, and constipation.
The medication is contraindicated in those with creatinine clearance below 15 mL/min/1.73 m2. Prescribing information advises that amantadine ER be avoided or used with caution in patients with a history of suicidality and depression, hallucinations or psychotic behavior, and orthostatic hypotension or dizziness.
Patients taking ER amantadine may also experience impulsivity and sexual, spending, or gambling urges. Abrupt withdrawal or rapid dose reduction may result in withdrawal-emergent hyperpyrexia or confusion, including delirium, hallucinations, stupor, and slurred speech.
The clinical trials upon which the approval is based were funded by Adamas Pharmaceuticals.
[email protected]
On Twitter @karioakes
The biliary tree and pancreas: An overview
The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.
Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.
Douglas Adler, MD, AGAF, provided pointers on distinguishing between malignant and benign biliary strictures. Ruling out a malignant stricture entails use of multiple diagnostic modalities to image and to sample abnormalities, such as a dominant stricture in primary sclerosing cholangitis. Fluorescence in situ hybridization (FISH) and cholangioscopy are fairly widely used, while other techniques such as confocal laser endomicroscopy are used less frequently. Benign biliary strictures occur frequently in the liver transplant population, both anastomotic and nonanastomotic. Benign biliary strictures may also occur in chronic pancreatitis; importantly, these may mimic pancreatic cancer.
During my presentation, we focused on several aspects of pancreaticobiliary neoplasia. We reviewed the multiple genetic syndromes such as Peutz-Jeghers syndrome, hereditary pancreatitis, and Lynch syndrome, all of which confer increased risk for pancreatic cancer. Endoscopic ultrasound guidance and adjunctive techniques (e.g., elastography) may improve imaging in the pancreas and improve targeting of biopsies. Needle-based confocal laser endomicroscopy is also available to provide real time cellular data, improving our ability to accurately diagnose and differentiate pancreatic cystic neoplasms. Endoscopic ultrasound–guided needle injection and other therapeutic techniques allow endoscopists to intervene therapeutically. Accurate management of pancreatic cysts depends largely on the accurate identification of mucinous cystic neoplasms. Recent guidelines delineate high-risk stigmata and worrisome features of branch-duct intraductal papillary mucinous neoplasm. We also reviewed less common neoplasms such as pancreatic neuroendocrine tumors and biliary neoplasms.
Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.
The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.
Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.
Douglas Adler, MD, AGAF, provided pointers on distinguishing between malignant and benign biliary strictures. Ruling out a malignant stricture entails use of multiple diagnostic modalities to image and to sample abnormalities, such as a dominant stricture in primary sclerosing cholangitis. Fluorescence in situ hybridization (FISH) and cholangioscopy are fairly widely used, while other techniques such as confocal laser endomicroscopy are used less frequently. Benign biliary strictures occur frequently in the liver transplant population, both anastomotic and nonanastomotic. Benign biliary strictures may also occur in chronic pancreatitis; importantly, these may mimic pancreatic cancer.
During my presentation, we focused on several aspects of pancreaticobiliary neoplasia. We reviewed the multiple genetic syndromes such as Peutz-Jeghers syndrome, hereditary pancreatitis, and Lynch syndrome, all of which confer increased risk for pancreatic cancer. Endoscopic ultrasound guidance and adjunctive techniques (e.g., elastography) may improve imaging in the pancreas and improve targeting of biopsies. Needle-based confocal laser endomicroscopy is also available to provide real time cellular data, improving our ability to accurately diagnose and differentiate pancreatic cystic neoplasms. Endoscopic ultrasound–guided needle injection and other therapeutic techniques allow endoscopists to intervene therapeutically. Accurate management of pancreatic cysts depends largely on the accurate identification of mucinous cystic neoplasms. Recent guidelines delineate high-risk stigmata and worrisome features of branch-duct intraductal papillary mucinous neoplasm. We also reviewed less common neoplasms such as pancreatic neuroendocrine tumors and biliary neoplasms.
Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.
The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.
Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.
Douglas Adler, MD, AGAF, provided pointers on distinguishing between malignant and benign biliary strictures. Ruling out a malignant stricture entails use of multiple diagnostic modalities to image and to sample abnormalities, such as a dominant stricture in primary sclerosing cholangitis. Fluorescence in situ hybridization (FISH) and cholangioscopy are fairly widely used, while other techniques such as confocal laser endomicroscopy are used less frequently. Benign biliary strictures occur frequently in the liver transplant population, both anastomotic and nonanastomotic. Benign biliary strictures may also occur in chronic pancreatitis; importantly, these may mimic pancreatic cancer.
During my presentation, we focused on several aspects of pancreaticobiliary neoplasia. We reviewed the multiple genetic syndromes such as Peutz-Jeghers syndrome, hereditary pancreatitis, and Lynch syndrome, all of which confer increased risk for pancreatic cancer. Endoscopic ultrasound guidance and adjunctive techniques (e.g., elastography) may improve imaging in the pancreas and improve targeting of biopsies. Needle-based confocal laser endomicroscopy is also available to provide real time cellular data, improving our ability to accurately diagnose and differentiate pancreatic cystic neoplasms. Endoscopic ultrasound–guided needle injection and other therapeutic techniques allow endoscopists to intervene therapeutically. Accurate management of pancreatic cysts depends largely on the accurate identification of mucinous cystic neoplasms. Recent guidelines delineate high-risk stigmata and worrisome features of branch-duct intraductal papillary mucinous neoplasm. We also reviewed less common neoplasms such as pancreatic neuroendocrine tumors and biliary neoplasms.
Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.
Cosmetic Corner: Dermatologists Weigh in on Athlete’s Foot Products
To improve patient care and outcomes, leading dermatologists offered their recommendations on athlete’s foot products. Consideration must be given to:
- LamisilAT Cream
GlaxoSmithKline plc
“I recommend Lamisil Cream twice daily for 2 to 4 weeks.”— Gary Goldenberg, MD, New York, New York
- LamisilAT Spray
GlaxoSmithKline plc
“This product is effective in treating fungus and allows for easy application with the ability of the spray to reach broad areas of the feet, including within the toe webs.”—Jeannette Graf, MD, New York, New York
- Tinactin Athlete’s Foot Powder Spray
Bayer
“I recommend all my patients with tinea pedis to spray this product in their shoes.”—Gary Goldenberg, MD, New York, New York
- Zeasorb Athlete’s Foot
Stiefel Laboratories, Inc
“I recommend this powder to treat tinea pedis and to prevent recurrences in patients who have been treated for onychomycosis.”—Shari Lipner, MD, PhD, New York, New York
Cutis invites readers to send us their recommendations. Postprocedural makeup, moisturizers for men, and wet skin moisturizer will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.
Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.
To improve patient care and outcomes, leading dermatologists offered their recommendations on athlete’s foot products. Consideration must be given to:
- LamisilAT Cream
GlaxoSmithKline plc
“I recommend Lamisil Cream twice daily for 2 to 4 weeks.”— Gary Goldenberg, MD, New York, New York
- LamisilAT Spray
GlaxoSmithKline plc
“This product is effective in treating fungus and allows for easy application with the ability of the spray to reach broad areas of the feet, including within the toe webs.”—Jeannette Graf, MD, New York, New York
- Tinactin Athlete’s Foot Powder Spray
Bayer
“I recommend all my patients with tinea pedis to spray this product in their shoes.”—Gary Goldenberg, MD, New York, New York
- Zeasorb Athlete’s Foot
Stiefel Laboratories, Inc
“I recommend this powder to treat tinea pedis and to prevent recurrences in patients who have been treated for onychomycosis.”—Shari Lipner, MD, PhD, New York, New York
Cutis invites readers to send us their recommendations. Postprocedural makeup, moisturizers for men, and wet skin moisturizer will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.
Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.
To improve patient care and outcomes, leading dermatologists offered their recommendations on athlete’s foot products. Consideration must be given to:
- LamisilAT Cream
GlaxoSmithKline plc
“I recommend Lamisil Cream twice daily for 2 to 4 weeks.”— Gary Goldenberg, MD, New York, New York
- LamisilAT Spray
GlaxoSmithKline plc
“This product is effective in treating fungus and allows for easy application with the ability of the spray to reach broad areas of the feet, including within the toe webs.”—Jeannette Graf, MD, New York, New York
- Tinactin Athlete’s Foot Powder Spray
Bayer
“I recommend all my patients with tinea pedis to spray this product in their shoes.”—Gary Goldenberg, MD, New York, New York
- Zeasorb Athlete’s Foot
Stiefel Laboratories, Inc
“I recommend this powder to treat tinea pedis and to prevent recurrences in patients who have been treated for onychomycosis.”—Shari Lipner, MD, PhD, New York, New York
Cutis invites readers to send us their recommendations. Postprocedural makeup, moisturizers for men, and wet skin moisturizer will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.
Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.
Student Hospitalist Scholars: Strengthening research skills
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.
I’m always surprised by how much I can learn in a few short weeks. I am now up to full speed with my project studying the utility of bone biopsies in the management of osteomyelitis.
This is a retrospective study, which means I’ll be collecting historical data from patient charts to be used for our analysis. My mentor – Ernie Esquivel, MD – has played an invaluable role in helping me get this project off the ground. He has worked with me on everything from project planning to successfully navigating the ever-confusing institutional review board (IRB) process. He has also provided advice in areas I thought I might actually have more experience, such as data collection and analysis methods.
This form has streamlined the data collection process and will save me a significant amount of time down the road when we have to code the data for statistical analysis programs. After putting in the hard work gathering all of this information, I look forward to beginning the process of analyzing and interpreting our results.
Dr. Esquivel has also helped me improve the value and credibility of this research by encouraging me to present our ideas in front of several groups of people from different departments and specialties. The feedback from these meetings has helped refine our study design and methods while also providing me with the opportunity to improve my communication and presentation skills.
I think such diverse input has helped shape this project into something that will be accessible to a broader audience, and has strengthened my understanding of why our work is important to both clinicians and patients.
Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.
I’m always surprised by how much I can learn in a few short weeks. I am now up to full speed with my project studying the utility of bone biopsies in the management of osteomyelitis.
This is a retrospective study, which means I’ll be collecting historical data from patient charts to be used for our analysis. My mentor – Ernie Esquivel, MD – has played an invaluable role in helping me get this project off the ground. He has worked with me on everything from project planning to successfully navigating the ever-confusing institutional review board (IRB) process. He has also provided advice in areas I thought I might actually have more experience, such as data collection and analysis methods.
This form has streamlined the data collection process and will save me a significant amount of time down the road when we have to code the data for statistical analysis programs. After putting in the hard work gathering all of this information, I look forward to beginning the process of analyzing and interpreting our results.
Dr. Esquivel has also helped me improve the value and credibility of this research by encouraging me to present our ideas in front of several groups of people from different departments and specialties. The feedback from these meetings has helped refine our study design and methods while also providing me with the opportunity to improve my communication and presentation skills.
I think such diverse input has helped shape this project into something that will be accessible to a broader audience, and has strengthened my understanding of why our work is important to both clinicians and patients.
Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.
I’m always surprised by how much I can learn in a few short weeks. I am now up to full speed with my project studying the utility of bone biopsies in the management of osteomyelitis.
This is a retrospective study, which means I’ll be collecting historical data from patient charts to be used for our analysis. My mentor – Ernie Esquivel, MD – has played an invaluable role in helping me get this project off the ground. He has worked with me on everything from project planning to successfully navigating the ever-confusing institutional review board (IRB) process. He has also provided advice in areas I thought I might actually have more experience, such as data collection and analysis methods.
This form has streamlined the data collection process and will save me a significant amount of time down the road when we have to code the data for statistical analysis programs. After putting in the hard work gathering all of this information, I look forward to beginning the process of analyzing and interpreting our results.
Dr. Esquivel has also helped me improve the value and credibility of this research by encouraging me to present our ideas in front of several groups of people from different departments and specialties. The feedback from these meetings has helped refine our study design and methods while also providing me with the opportunity to improve my communication and presentation skills.
I think such diverse input has helped shape this project into something that will be accessible to a broader audience, and has strengthened my understanding of why our work is important to both clinicians and patients.
Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.
Tips for Living With Bipolar Disorder
Click here to download the PDF. 
Click here to download the PDF.
Click here to download the PDF.
