The Food and Drug Administration has approved a new paclitaxel-eluting stent indciated for the treatment of peripheral artery disease.

The Zilver PTX Drug-Eluting Peripheral Stent, which is manufactured by Cook Medical of Bloomington, Ind., is the first drug-eluting stent to win approval for this indication.

Courtesy Dr. Fabrizio Fanelli / Copyright COOK Medical 

The approval was based on findings from both a randomized controlled trial and on a registry study, which together comprised more than 1,200 patients.

According to an FDA press statement, the studies indicate that treatment with the stent "is at least as safe as treatment with percutaneous transluminal angioplasty (PTA) and significantly more effective."

The randomized trial included a total of 479 patients who had a single stenotic lesion less than 140 mm in one or both of the femoropopliteal arteries.

The patients were randomized to the paclitaxel-eluting stent or to PTA. If the transluminal procedure failed, then the patients received either the paclitaxel-eluting stent or a bare-metal stent.

After 12 months, 83% of the arteries treated with the drug-eluting stent were still open, compared with 33% of those in the PTA group.

In those patients who had the stent placed after a failed PTA, 90% of arteries were open, compared with 73% in those who got the bare-metal stent.

In October 2011, the FDA's Circulatory System Devices Panel voted 11 to 0 that the benefits of the Zilver PTX stent outweighed its risks as a treatment for patients with symptomatic atherosclerotic stenosis of the femoropopliteal arteries on the basis of that trial.

This past October, the 3-year results of the study were presented at the Vascular Interventional Advances 2012 meeting in Las Vegas. The results showed that there was a 70.7% primary patency seen for the paclitaxel-eluting stent, compared with 49.1% for PTA and bare-metal stents.

The registry study followed 767 patients for 24 months. These patients had a maximum of four stents placed; the stents could be utilized to treat a single lesion or to treat multiple lesions.

At 12 months, the fracture rate was 1.5%; fractures were not associated with any clinical problems. The rate of stent thrombosis was 2.8% at 12 months and 3.5% at 24 months.

"The clinical study demonstrated that the [the paclitaxel-eluting stent] is more effective than the use of balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the statement.

"This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease," she added.

In both studies, the most common major adverse event was restenosis requiring additional treatment to reestablish adequate flow in the artery. 

The device is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent.

It is also contraindicated in patients who cannot receive recommended drug therapy due to bleeding disorders, or women who are pregnant, breastfeeding, or planning to become pregnant in the next 5 years.

The FDA will now require the manufacturer to conduct a 5-year postapproval study of 900 patients to further evaluate the stent's safety and efficacy.

[email protected]

The Food and Drug Administration has approved a new paclitaxel-eluting stent indciated for the treatment of peripheral artery disease.

The Zilver PTX Drug-Eluting Peripheral Stent, which is manufactured by Cook Medical of Bloomington, Ind., is the first drug-eluting stent to win approval for this indication.

Courtesy Dr. Fabrizio Fanelli / Copyright COOK Medical 

The approval was based on findings from both a randomized controlled trial and on a registry study, which together comprised more than 1,200 patients.

According to an FDA press statement, the studies indicate that treatment with the stent "is at least as safe as treatment with percutaneous transluminal angioplasty (PTA) and significantly more effective."

The randomized trial included a total of 479 patients who had a single stenotic lesion less than 140 mm in one or both of the femoropopliteal arteries.

The patients were randomized to the paclitaxel-eluting stent or to PTA. If the transluminal procedure failed, then the patients received either the paclitaxel-eluting stent or a bare-metal stent.

After 12 months, 83% of the arteries treated with the drug-eluting stent were still open, compared with 33% of those in the PTA group.

In those patients who had the stent placed after a failed PTA, 90% of arteries were open, compared with 73% in those who got the bare-metal stent.

In October 2011, the FDA's Circulatory System Devices Panel voted 11 to 0 that the benefits of the Zilver PTX stent outweighed its risks as a treatment for patients with symptomatic atherosclerotic stenosis of the femoropopliteal arteries on the basis of that trial.

This past October, the 3-year results of the study were presented at the Vascular Interventional Advances 2012 meeting in Las Vegas. The results showed that there was a 70.7% primary patency seen for the paclitaxel-eluting stent, compared with 49.1% for PTA and bare-metal stents.

The registry study followed 767 patients for 24 months. These patients had a maximum of four stents placed; the stents could be utilized to treat a single lesion or to treat multiple lesions.

At 12 months, the fracture rate was 1.5%; fractures were not associated with any clinical problems. The rate of stent thrombosis was 2.8% at 12 months and 3.5% at 24 months.

"The clinical study demonstrated that the [the paclitaxel-eluting stent] is more effective than the use of balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the statement.

"This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease," she added.

In both studies, the most common major adverse event was restenosis requiring additional treatment to reestablish adequate flow in the artery. 

The device is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent.

It is also contraindicated in patients who cannot receive recommended drug therapy due to bleeding disorders, or women who are pregnant, breastfeeding, or planning to become pregnant in the next 5 years.

The FDA will now require the manufacturer to conduct a 5-year postapproval study of 900 patients to further evaluate the stent's safety and efficacy.

[email protected]

The Food and Drug Administration has approved a new paclitaxel-eluting stent indciated for the treatment of peripheral artery disease.

The Zilver PTX Drug-Eluting Peripheral Stent, which is manufactured by Cook Medical of Bloomington, Ind., is the first drug-eluting stent to win approval for this indication.

Courtesy Dr. Fabrizio Fanelli / Copyright COOK Medical 

The approval was based on findings from both a randomized controlled trial and on a registry study, which together comprised more than 1,200 patients.

According to an FDA press statement, the studies indicate that treatment with the stent "is at least as safe as treatment with percutaneous transluminal angioplasty (PTA) and significantly more effective."

The randomized trial included a total of 479 patients who had a single stenotic lesion less than 140 mm in one or both of the femoropopliteal arteries.

The patients were randomized to the paclitaxel-eluting stent or to PTA. If the transluminal procedure failed, then the patients received either the paclitaxel-eluting stent or a bare-metal stent.

After 12 months, 83% of the arteries treated with the drug-eluting stent were still open, compared with 33% of those in the PTA group.

In those patients who had the stent placed after a failed PTA, 90% of arteries were open, compared with 73% in those who got the bare-metal stent.

In October 2011, the FDA's Circulatory System Devices Panel voted 11 to 0 that the benefits of the Zilver PTX stent outweighed its risks as a treatment for patients with symptomatic atherosclerotic stenosis of the femoropopliteal arteries on the basis of that trial.

This past October, the 3-year results of the study were presented at the Vascular Interventional Advances 2012 meeting in Las Vegas. The results showed that there was a 70.7% primary patency seen for the paclitaxel-eluting stent, compared with 49.1% for PTA and bare-metal stents.

The registry study followed 767 patients for 24 months. These patients had a maximum of four stents placed; the stents could be utilized to treat a single lesion or to treat multiple lesions.

At 12 months, the fracture rate was 1.5%; fractures were not associated with any clinical problems. The rate of stent thrombosis was 2.8% at 12 months and 3.5% at 24 months.

"The clinical study demonstrated that the [the paclitaxel-eluting stent] is more effective than the use of balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the statement.

"This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease," she added.

In both studies, the most common major adverse event was restenosis requiring additional treatment to reestablish adequate flow in the artery. 

The device is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent.

It is also contraindicated in patients who cannot receive recommended drug therapy due to bleeding disorders, or women who are pregnant, breastfeeding, or planning to become pregnant in the next 5 years.

The FDA will now require the manufacturer to conduct a 5-year postapproval study of 900 patients to further evaluate the stent's safety and efficacy.

[email protected]

Most of us struggle to be proficient in that fine art of balancing high-quality, cost-effective medical care, patient and family satisfaction, and length of stay. One, or even two, of these without the other, just won’t cut muster these days, and with the CMS Hospital Readmissions Reduction Program, the pressure is on to cut readmissions within 30 days of discharge, or else! (Section 3025 of the Affordable Care Act requires the CMS to reduce payments to acute care hospitals with excessive readmission rates as of Oct. 1, 2012.)

Realistically, we all know that even if we provide the best medical care possible, there will always be patients with chronic, end-stage disease whom we will never "fix." The best we can do is optimize the quality of their lives until they die or are readmitted and the cycle begins again. But there may be much more we as hospitalists can do to optimize the overall care of our patients to improve their outcomes, and save our hospitals a great deal of money at the same time.

"Post-Hospital Syndrome – An Acquired, Transient Condition of Generalized Risk" an article published Jan. 10 in the New England Journal of Medicine, gives excellent insight into underappreciated factors that result in readmission to the hospital (N. Engl. J. Med. 2013;368:100-2). Approximately one-fifth of Medicare patients admitted to a hospital require readmission within 30 days, surprisingly often for conditions completely unrelated to the original reason for admission. For instance, among patients initially admitted for heart failure, only 37% of readmissions within 30 days were for worsening heart failure. Likewise, after a hospitalization for a COPD exacerbation, only 36% of readmissions within 30 days were for another exacerbation.

Regardless of the original reason for admission, common causes of readmission include infection, gastrointestinal conditions, metabolic derangements, mental illness, trauma, heart failure, COPD, and pneumonia. And, despite what would seem intuitive, the severity of the initial illness did not help predict which patients would require readmission.

Sleep deprivation is a major contributor to postdischarge morbidity. Polysomnographic studies have demonstrated a reduction in REM sleep and an increase in non-REM sleep in hospitalized patients. Sleep deprivation is known to adversely impact immune function, cardiac risk, and even the coagulation cascade, in addition to the more obvious things such as mental function, ability to ambulate safely, and emotional well-being.

Inadequate nutrition is another culprit. Between being NPO for procedures, which are commonly rescheduled, feeling too sick (or too groggy) to eat, and the increased catabolic demands of many acute illnesses, the pendulum often swings far away from a homeostasis into a potentially dangerous zone, despite how the patient may look at first glance. Some potential consequences of poor nutrition include impaired wound healing, increased infection risk, and decreased cardiac and respiratory function.

Other factors, such as uncontrolled pain, a host of new medications – with myriad side effects – and deconditioning from lying in bed for prolonged periods also play key roles in setting patients up for a potentially debilitating vulnerability that often results in yet another acute illness requiring hospitalization not long after their initial discharge.

We ought to start thinking about discharge planning when we first admit patients. Based on this article, we need to include innovative ways to decrease the posthospital syndrome. There are some simple things we can do: Optimize pain control, get them out of bed as soon as possible, and create an environment to facilitate peaceful sleep. For example, we can easily minimize interruptions during early morning hours for vital sign checks and blood draws in stable patients. (Do we really need routine follow-up lab to be drawn at 6 a.m. in every patient?)

We should all think about our workflow and what we can do differently to minimize the physiologic vulnerability of our patients at discharge so they can be safely discharged (and stay discharged).

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care. 

Most of us struggle to be proficient in that fine art of balancing high-quality, cost-effective medical care, patient and family satisfaction, and length of stay. One, or even two, of these without the other, just won’t cut muster these days, and with the CMS Hospital Readmissions Reduction Program, the pressure is on to cut readmissions within 30 days of discharge, or else! (Section 3025 of the Affordable Care Act requires the CMS to reduce payments to acute care hospitals with excessive readmission rates as of Oct. 1, 2012.)

Realistically, we all know that even if we provide the best medical care possible, there will always be patients with chronic, end-stage disease whom we will never "fix." The best we can do is optimize the quality of their lives until they die or are readmitted and the cycle begins again. But there may be much more we as hospitalists can do to optimize the overall care of our patients to improve their outcomes, and save our hospitals a great deal of money at the same time.

"Post-Hospital Syndrome – An Acquired, Transient Condition of Generalized Risk" an article published Jan. 10 in the New England Journal of Medicine, gives excellent insight into underappreciated factors that result in readmission to the hospital (N. Engl. J. Med. 2013;368:100-2). Approximately one-fifth of Medicare patients admitted to a hospital require readmission within 30 days, surprisingly often for conditions completely unrelated to the original reason for admission. For instance, among patients initially admitted for heart failure, only 37% of readmissions within 30 days were for worsening heart failure. Likewise, after a hospitalization for a COPD exacerbation, only 36% of readmissions within 30 days were for another exacerbation.

Regardless of the original reason for admission, common causes of readmission include infection, gastrointestinal conditions, metabolic derangements, mental illness, trauma, heart failure, COPD, and pneumonia. And, despite what would seem intuitive, the severity of the initial illness did not help predict which patients would require readmission.

Sleep deprivation is a major contributor to postdischarge morbidity. Polysomnographic studies have demonstrated a reduction in REM sleep and an increase in non-REM sleep in hospitalized patients. Sleep deprivation is known to adversely impact immune function, cardiac risk, and even the coagulation cascade, in addition to the more obvious things such as mental function, ability to ambulate safely, and emotional well-being.

Inadequate nutrition is another culprit. Between being NPO for procedures, which are commonly rescheduled, feeling too sick (or too groggy) to eat, and the increased catabolic demands of many acute illnesses, the pendulum often swings far away from a homeostasis into a potentially dangerous zone, despite how the patient may look at first glance. Some potential consequences of poor nutrition include impaired wound healing, increased infection risk, and decreased cardiac and respiratory function.

Other factors, such as uncontrolled pain, a host of new medications – with myriad side effects – and deconditioning from lying in bed for prolonged periods also play key roles in setting patients up for a potentially debilitating vulnerability that often results in yet another acute illness requiring hospitalization not long after their initial discharge.

We ought to start thinking about discharge planning when we first admit patients. Based on this article, we need to include innovative ways to decrease the posthospital syndrome. There are some simple things we can do: Optimize pain control, get them out of bed as soon as possible, and create an environment to facilitate peaceful sleep. For example, we can easily minimize interruptions during early morning hours for vital sign checks and blood draws in stable patients. (Do we really need routine follow-up lab to be drawn at 6 a.m. in every patient?)

We should all think about our workflow and what we can do differently to minimize the physiologic vulnerability of our patients at discharge so they can be safely discharged (and stay discharged).

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care. 

Most of us struggle to be proficient in that fine art of balancing high-quality, cost-effective medical care, patient and family satisfaction, and length of stay. One, or even two, of these without the other, just won’t cut muster these days, and with the CMS Hospital Readmissions Reduction Program, the pressure is on to cut readmissions within 30 days of discharge, or else! (Section 3025 of the Affordable Care Act requires the CMS to reduce payments to acute care hospitals with excessive readmission rates as of Oct. 1, 2012.)

Realistically, we all know that even if we provide the best medical care possible, there will always be patients with chronic, end-stage disease whom we will never "fix." The best we can do is optimize the quality of their lives until they die or are readmitted and the cycle begins again. But there may be much more we as hospitalists can do to optimize the overall care of our patients to improve their outcomes, and save our hospitals a great deal of money at the same time.

"Post-Hospital Syndrome – An Acquired, Transient Condition of Generalized Risk" an article published Jan. 10 in the New England Journal of Medicine, gives excellent insight into underappreciated factors that result in readmission to the hospital (N. Engl. J. Med. 2013;368:100-2). Approximately one-fifth of Medicare patients admitted to a hospital require readmission within 30 days, surprisingly often for conditions completely unrelated to the original reason for admission. For instance, among patients initially admitted for heart failure, only 37% of readmissions within 30 days were for worsening heart failure. Likewise, after a hospitalization for a COPD exacerbation, only 36% of readmissions within 30 days were for another exacerbation.

Regardless of the original reason for admission, common causes of readmission include infection, gastrointestinal conditions, metabolic derangements, mental illness, trauma, heart failure, COPD, and pneumonia. And, despite what would seem intuitive, the severity of the initial illness did not help predict which patients would require readmission.

Sleep deprivation is a major contributor to postdischarge morbidity. Polysomnographic studies have demonstrated a reduction in REM sleep and an increase in non-REM sleep in hospitalized patients. Sleep deprivation is known to adversely impact immune function, cardiac risk, and even the coagulation cascade, in addition to the more obvious things such as mental function, ability to ambulate safely, and emotional well-being.

Inadequate nutrition is another culprit. Between being NPO for procedures, which are commonly rescheduled, feeling too sick (or too groggy) to eat, and the increased catabolic demands of many acute illnesses, the pendulum often swings far away from a homeostasis into a potentially dangerous zone, despite how the patient may look at first glance. Some potential consequences of poor nutrition include impaired wound healing, increased infection risk, and decreased cardiac and respiratory function.

Other factors, such as uncontrolled pain, a host of new medications – with myriad side effects – and deconditioning from lying in bed for prolonged periods also play key roles in setting patients up for a potentially debilitating vulnerability that often results in yet another acute illness requiring hospitalization not long after their initial discharge.

We ought to start thinking about discharge planning when we first admit patients. Based on this article, we need to include innovative ways to decrease the posthospital syndrome. There are some simple things we can do: Optimize pain control, get them out of bed as soon as possible, and create an environment to facilitate peaceful sleep. For example, we can easily minimize interruptions during early morning hours for vital sign checks and blood draws in stable patients. (Do we really need routine follow-up lab to be drawn at 6 a.m. in every patient?)

We should all think about our workflow and what we can do differently to minimize the physiologic vulnerability of our patients at discharge so they can be safely discharged (and stay discharged).

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care. 

We psychiatrists should take a biopsychosocial approach to assessing our patients. However, we are enamored with biology and individual psychodynamics. Thus, we often overlook the influence of culture, or the lack thereof, on human behavior.

The assertion of Dr. Douglas K. Novins that using foundational cultural beliefs and practices strengthens interventions with people of color is particularly powerful. Furthermore, Dr. Novins’s findings inform us about the importance of culture in the protective factors and risky behaviors of our patients.

Culture Protects

While doing HIV prevention work in Durban, South Africa, I found it striking that 40% of the black African Zulu people were HIV positive, 6% of the white South Africans were HIV positive, but only 1% of the East Indian South Africans were HIV positive.

As it turns out, the East Indian South African culture (with its intact religious rituals, proscribed clothing customs, age-old mating practices, and so on) protected them. Meanwhile, the black African Zulu culture and its protective cultural influence had been stripped from them, making them vulnerable to activities such as risky sexual behavior, substance abuse, and violence.

In addition, it appears that the white South African culture is eroding, which is resulting in higher levels of HIV-positive individuals.

Culture Destroys

The latest Youth Risk Behavior Surveillance data offer a glimpse into just how paradoxical our world has become. The investigators looked at six categories of health-risk behaviors among young people and young adults.

Among their findings: The prevalence of having carried a weapon in general was higher among white males (27.2%) than among their black counterparts (21%). The prevalence of having carried a weapon onto school property was higher among white males (7.8%) than black males (6.7%). The prevalence of having ever used cocaine was higher among white males (7.6%) than black males (4.2%). Yet, people of color make up a higher proportion of children and young adults who are incarcerated. In fact, in 2010, the imprisonment rate for black non-Hispanic males (3,074/100,000 U.S. black male residents) was almost seven times higher than it was for white non-Hispanic males (459/100,000), according to the U.S. Bureau of Justice Statistics.

Some of these disparities can be deconstructed by looking at housing patterns. Structurally, we understand that most mid- and large-size cities have more absolute numbers of low-income whites than low-income blacks. But few low-income white neighborhoods exist because low-income whites have scattered-site housing, while low-income blacks are concentrated in inner cities. Police have a more difficult time finding and incarcerating illegal drug users when they live in scattered-site housing. Therefore, blacks who use illegal drugs are incarcerated more often than whites who use illegal drugs.

We also must acknowledge that some of these disparities are tied to the human construct of race. Buy-in to this construct explains why law enforcement officers traditionally "hunted" runaway slaves and returned them to their owners. It potentially explains the motivations of former Chicago police officer Jon Burge, who was convicted 2 years ago of lying about the torture of innocent black men in order to get confessions over many decades. Finally, this reality explains the thinking behind this saying in Chicago’s black community: "The police hunt black males!"

International psychiatrist Suman Fernando makes the point in his book "Mental Health, Race and Culture: Third Edition" (New York: Palgrave Macmillan, 2010) that much of Western culture is inherently racist. Derald Wing Sue, Ph.D., the preeminent multicultural scholar, reminds us of "ethnocentric monoculturalism," the notion that the only culture in the Western world that has any value is Western culture, and all other cultural values and practices are "primitive." Dr. Sue points out that ethnocentric monoculturalism and whiteness define a reality that puts those who are white European American males at an advantage (American Psychologist 2004;59:761-9).

In Canada, these destructive, entrenched views led to the removal of children from First Nations communities. This cultural dislocation, in turn, led to the loss of cultural protective factors, which ultimately contributed to the engagement in risky behaviors tied to suicide, intragroup homicide, and substance abuse. As I’ve discussed previously, many of the disruptive behaviors that result in incarceration can be traced back to alcohol consumption (Preventing fetal alcohol syndrome, April 12, 2012). It is well known that this syndrome is a leading cause of speech and language disorders, attention-deficit/hyperactivity disorder, and other developmental/cognitive disorders. These are often responsible for affect dysregulation, which leads to disruptive behaviors – which, in turn, can lead to incarceration.

It is heartening to see research like that produced by Dr. Novins and his colleagues. Their work reaffirms that culture protects. It also is a reminder that psychiatrists need to understand the sociological forces that exacerbate the emotional pain suffered by our patients – particularly those who are marginalized. We must redouble our efforts to incorporate respectful cultural components into our interventions. Doing so will produce better outcomes.

Dr. Bell is president and chief executive officer of Community Mental Health Council Inc. in Chicago. He also serves as director of the Institute for Juvenile Research at the University of Illinois at Chicago, and is director of public health and community psychiatry at the university.

We psychiatrists should take a biopsychosocial approach to assessing our patients. However, we are enamored with biology and individual psychodynamics. Thus, we often overlook the influence of culture, or the lack thereof, on human behavior.

The assertion of Dr. Douglas K. Novins that using foundational cultural beliefs and practices strengthens interventions with people of color is particularly powerful. Furthermore, Dr. Novins’s findings inform us about the importance of culture in the protective factors and risky behaviors of our patients.

Culture Protects

While doing HIV prevention work in Durban, South Africa, I found it striking that 40% of the black African Zulu people were HIV positive, 6% of the white South Africans were HIV positive, but only 1% of the East Indian South Africans were HIV positive.

As it turns out, the East Indian South African culture (with its intact religious rituals, proscribed clothing customs, age-old mating practices, and so on) protected them. Meanwhile, the black African Zulu culture and its protective cultural influence had been stripped from them, making them vulnerable to activities such as risky sexual behavior, substance abuse, and violence.

In addition, it appears that the white South African culture is eroding, which is resulting in higher levels of HIV-positive individuals.

Culture Destroys

The latest Youth Risk Behavior Surveillance data offer a glimpse into just how paradoxical our world has become. The investigators looked at six categories of health-risk behaviors among young people and young adults.

Among their findings: The prevalence of having carried a weapon in general was higher among white males (27.2%) than among their black counterparts (21%). The prevalence of having carried a weapon onto school property was higher among white males (7.8%) than black males (6.7%). The prevalence of having ever used cocaine was higher among white males (7.6%) than black males (4.2%). Yet, people of color make up a higher proportion of children and young adults who are incarcerated. In fact, in 2010, the imprisonment rate for black non-Hispanic males (3,074/100,000 U.S. black male residents) was almost seven times higher than it was for white non-Hispanic males (459/100,000), according to the U.S. Bureau of Justice Statistics.

Some of these disparities can be deconstructed by looking at housing patterns. Structurally, we understand that most mid- and large-size cities have more absolute numbers of low-income whites than low-income blacks. But few low-income white neighborhoods exist because low-income whites have scattered-site housing, while low-income blacks are concentrated in inner cities. Police have a more difficult time finding and incarcerating illegal drug users when they live in scattered-site housing. Therefore, blacks who use illegal drugs are incarcerated more often than whites who use illegal drugs.

We also must acknowledge that some of these disparities are tied to the human construct of race. Buy-in to this construct explains why law enforcement officers traditionally "hunted" runaway slaves and returned them to their owners. It potentially explains the motivations of former Chicago police officer Jon Burge, who was convicted 2 years ago of lying about the torture of innocent black men in order to get confessions over many decades. Finally, this reality explains the thinking behind this saying in Chicago’s black community: "The police hunt black males!"

International psychiatrist Suman Fernando makes the point in his book "Mental Health, Race and Culture: Third Edition" (New York: Palgrave Macmillan, 2010) that much of Western culture is inherently racist. Derald Wing Sue, Ph.D., the preeminent multicultural scholar, reminds us of "ethnocentric monoculturalism," the notion that the only culture in the Western world that has any value is Western culture, and all other cultural values and practices are "primitive." Dr. Sue points out that ethnocentric monoculturalism and whiteness define a reality that puts those who are white European American males at an advantage (American Psychologist 2004;59:761-9).

In Canada, these destructive, entrenched views led to the removal of children from First Nations communities. This cultural dislocation, in turn, led to the loss of cultural protective factors, which ultimately contributed to the engagement in risky behaviors tied to suicide, intragroup homicide, and substance abuse. As I’ve discussed previously, many of the disruptive behaviors that result in incarceration can be traced back to alcohol consumption (Preventing fetal alcohol syndrome, April 12, 2012). It is well known that this syndrome is a leading cause of speech and language disorders, attention-deficit/hyperactivity disorder, and other developmental/cognitive disorders. These are often responsible for affect dysregulation, which leads to disruptive behaviors – which, in turn, can lead to incarceration.

It is heartening to see research like that produced by Dr. Novins and his colleagues. Their work reaffirms that culture protects. It also is a reminder that psychiatrists need to understand the sociological forces that exacerbate the emotional pain suffered by our patients – particularly those who are marginalized. We must redouble our efforts to incorporate respectful cultural components into our interventions. Doing so will produce better outcomes.

Dr. Bell is president and chief executive officer of Community Mental Health Council Inc. in Chicago. He also serves as director of the Institute for Juvenile Research at the University of Illinois at Chicago, and is director of public health and community psychiatry at the university.

We psychiatrists should take a biopsychosocial approach to assessing our patients. However, we are enamored with biology and individual psychodynamics. Thus, we often overlook the influence of culture, or the lack thereof, on human behavior.

The assertion of Dr. Douglas K. Novins that using foundational cultural beliefs and practices strengthens interventions with people of color is particularly powerful. Furthermore, Dr. Novins’s findings inform us about the importance of culture in the protective factors and risky behaviors of our patients.

Culture Protects

While doing HIV prevention work in Durban, South Africa, I found it striking that 40% of the black African Zulu people were HIV positive, 6% of the white South Africans were HIV positive, but only 1% of the East Indian South Africans were HIV positive.

As it turns out, the East Indian South African culture (with its intact religious rituals, proscribed clothing customs, age-old mating practices, and so on) protected them. Meanwhile, the black African Zulu culture and its protective cultural influence had been stripped from them, making them vulnerable to activities such as risky sexual behavior, substance abuse, and violence.

In addition, it appears that the white South African culture is eroding, which is resulting in higher levels of HIV-positive individuals.

Culture Destroys

The latest Youth Risk Behavior Surveillance data offer a glimpse into just how paradoxical our world has become. The investigators looked at six categories of health-risk behaviors among young people and young adults.

Among their findings: The prevalence of having carried a weapon in general was higher among white males (27.2%) than among their black counterparts (21%). The prevalence of having carried a weapon onto school property was higher among white males (7.8%) than black males (6.7%). The prevalence of having ever used cocaine was higher among white males (7.6%) than black males (4.2%). Yet, people of color make up a higher proportion of children and young adults who are incarcerated. In fact, in 2010, the imprisonment rate for black non-Hispanic males (3,074/100,000 U.S. black male residents) was almost seven times higher than it was for white non-Hispanic males (459/100,000), according to the U.S. Bureau of Justice Statistics.

Some of these disparities can be deconstructed by looking at housing patterns. Structurally, we understand that most mid- and large-size cities have more absolute numbers of low-income whites than low-income blacks. But few low-income white neighborhoods exist because low-income whites have scattered-site housing, while low-income blacks are concentrated in inner cities. Police have a more difficult time finding and incarcerating illegal drug users when they live in scattered-site housing. Therefore, blacks who use illegal drugs are incarcerated more often than whites who use illegal drugs.

We also must acknowledge that some of these disparities are tied to the human construct of race. Buy-in to this construct explains why law enforcement officers traditionally "hunted" runaway slaves and returned them to their owners. It potentially explains the motivations of former Chicago police officer Jon Burge, who was convicted 2 years ago of lying about the torture of innocent black men in order to get confessions over many decades. Finally, this reality explains the thinking behind this saying in Chicago’s black community: "The police hunt black males!"

International psychiatrist Suman Fernando makes the point in his book "Mental Health, Race and Culture: Third Edition" (New York: Palgrave Macmillan, 2010) that much of Western culture is inherently racist. Derald Wing Sue, Ph.D., the preeminent multicultural scholar, reminds us of "ethnocentric monoculturalism," the notion that the only culture in the Western world that has any value is Western culture, and all other cultural values and practices are "primitive." Dr. Sue points out that ethnocentric monoculturalism and whiteness define a reality that puts those who are white European American males at an advantage (American Psychologist 2004;59:761-9).

In Canada, these destructive, entrenched views led to the removal of children from First Nations communities. This cultural dislocation, in turn, led to the loss of cultural protective factors, which ultimately contributed to the engagement in risky behaviors tied to suicide, intragroup homicide, and substance abuse. As I’ve discussed previously, many of the disruptive behaviors that result in incarceration can be traced back to alcohol consumption (Preventing fetal alcohol syndrome, April 12, 2012). It is well known that this syndrome is a leading cause of speech and language disorders, attention-deficit/hyperactivity disorder, and other developmental/cognitive disorders. These are often responsible for affect dysregulation, which leads to disruptive behaviors – which, in turn, can lead to incarceration.

It is heartening to see research like that produced by Dr. Novins and his colleagues. Their work reaffirms that culture protects. It also is a reminder that psychiatrists need to understand the sociological forces that exacerbate the emotional pain suffered by our patients – particularly those who are marginalized. We must redouble our efforts to incorporate respectful cultural components into our interventions. Doing so will produce better outcomes.

Dr. Bell is president and chief executive officer of Community Mental Health Council Inc. in Chicago. He also serves as director of the Institute for Juvenile Research at the University of Illinois at Chicago, and is director of public health and community psychiatry at the university.

A test that can detect multiple causes of infectious gastroenteritis in one stool sample has been cleared for marketing by the Food and Drug Administration.

The xTAG Gastrointestinal Pathogen Panel (GPP), a multiplexed nucleic acid test, is the "first test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample," the agency said in a Jan. 14 statement announcing the approval.

Courtesy CDC/Dr. Gilda Jones

The xTAG GPP tests for the bacteria Campylobacter, Clostridium difficile toxin A/B, Escherichia coli O157, enterotoxigenic E. coli (ETEC) LT/ST, Salmonella, Shigella, and Shiga-like toxin-producing E. coli (STEC) stx1/stx2; the viruses norovirus and rotavirus A; and the parasites Cryptosporidium and Giardia lamblia.

This test can help clinicians identify and treat the cause of gastroenteritis in patients more quickly, and "could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in the statement.

In studies conducted by the manufacturer, Luminex, results of the xTAG GPP were "comparable" with the results of individual tests for the 11 pathogens in stool samples from 1,407 patients with suspected infectious gastroenteritis, 313 samples from pediatric patients with suspected infectious gastroenteritis, and 203 samples from patients with confirmed cases of infectious gastroenteritis, according to the FDA. Because of the risk of false positives, "all positive results from the xTAG GPP need to be confirmed by additional testing," the agency’s announcement said.

The test, which is now available in the United States, can provide multiple results within 5 hours. It is the first and most comprehensive multiplexed product of its kind in the United States, according to a statement from Luminex.

The FDA cites data from the Centers for Disease Control and Prevention reporting that the number of deaths associated with gastroenteritis increased from nearly 7,000 to more than 17,000 per year between 1999 and 2007 in the United States. Two-thirds of the deaths were attributed to norovirus and C. difficile. 

[email protected]

A test that can detect multiple causes of infectious gastroenteritis in one stool sample has been cleared for marketing by the Food and Drug Administration.

The xTAG Gastrointestinal Pathogen Panel (GPP), a multiplexed nucleic acid test, is the "first test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample," the agency said in a Jan. 14 statement announcing the approval.

Courtesy CDC/Dr. Gilda Jones

The xTAG GPP tests for the bacteria Campylobacter, Clostridium difficile toxin A/B, Escherichia coli O157, enterotoxigenic E. coli (ETEC) LT/ST, Salmonella, Shigella, and Shiga-like toxin-producing E. coli (STEC) stx1/stx2; the viruses norovirus and rotavirus A; and the parasites Cryptosporidium and Giardia lamblia.

This test can help clinicians identify and treat the cause of gastroenteritis in patients more quickly, and "could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in the statement.

In studies conducted by the manufacturer, Luminex, results of the xTAG GPP were "comparable" with the results of individual tests for the 11 pathogens in stool samples from 1,407 patients with suspected infectious gastroenteritis, 313 samples from pediatric patients with suspected infectious gastroenteritis, and 203 samples from patients with confirmed cases of infectious gastroenteritis, according to the FDA. Because of the risk of false positives, "all positive results from the xTAG GPP need to be confirmed by additional testing," the agency’s announcement said.

The test, which is now available in the United States, can provide multiple results within 5 hours. It is the first and most comprehensive multiplexed product of its kind in the United States, according to a statement from Luminex.

The FDA cites data from the Centers for Disease Control and Prevention reporting that the number of deaths associated with gastroenteritis increased from nearly 7,000 to more than 17,000 per year between 1999 and 2007 in the United States. Two-thirds of the deaths were attributed to norovirus and C. difficile. 

[email protected]

A test that can detect multiple causes of infectious gastroenteritis in one stool sample has been cleared for marketing by the Food and Drug Administration.

The xTAG Gastrointestinal Pathogen Panel (GPP), a multiplexed nucleic acid test, is the "first test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample," the agency said in a Jan. 14 statement announcing the approval.

Courtesy CDC/Dr. Gilda Jones

The xTAG GPP tests for the bacteria Campylobacter, Clostridium difficile toxin A/B, Escherichia coli O157, enterotoxigenic E. coli (ETEC) LT/ST, Salmonella, Shigella, and Shiga-like toxin-producing E. coli (STEC) stx1/stx2; the viruses norovirus and rotavirus A; and the parasites Cryptosporidium and Giardia lamblia.

This test can help clinicians identify and treat the cause of gastroenteritis in patients more quickly, and "could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in the statement.

In studies conducted by the manufacturer, Luminex, results of the xTAG GPP were "comparable" with the results of individual tests for the 11 pathogens in stool samples from 1,407 patients with suspected infectious gastroenteritis, 313 samples from pediatric patients with suspected infectious gastroenteritis, and 203 samples from patients with confirmed cases of infectious gastroenteritis, according to the FDA. Because of the risk of false positives, "all positive results from the xTAG GPP need to be confirmed by additional testing," the agency’s announcement said.

The test, which is now available in the United States, can provide multiple results within 5 hours. It is the first and most comprehensive multiplexed product of its kind in the United States, according to a statement from Luminex.

The FDA cites data from the Centers for Disease Control and Prevention reporting that the number of deaths associated with gastroenteritis increased from nearly 7,000 to more than 17,000 per year between 1999 and 2007 in the United States. Two-thirds of the deaths were attributed to norovirus and C. difficile. 

[email protected]

The risk of postoperative hemorrhage after transoral robotic-assisted surgery was significantly higher in patients taking antithrombotic medication than in those not taking it, based on data from 147 consecutive patients.

"Even with this small sample size, we were able to identify that increased risk was associated with antithrombotic medication use," said Dr. Scott Asher of the University of Alabama at Birmingham.

Transoral robotic-assisted surgery (TORS) is gaining in popularity among head and neck surgeons, but the potential for postop bleeding in patients taking antithrombotic medication remains a problem, Dr. Asher said at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.

To assess the postop bleeding complications in TORS patients, Dr. Asher and his colleagues reviewed data from patients seen at a single tertiary academic medical center between March 2007 and September 2011.

Overall, 11 patients (8%) experienced some postop hemorrhage, but 8 of these hemorrhages (72%) occurred in patients taking antithrombotics, Dr. Asher said. Nine patients who hemorrhaged returned to the operating room for further examination and bleeding control, he noted. All postop hemorrhage events were controlled with standard techniques.

The incidence of postop hemorrhage was significantly higher among patients on antithrombotics (17%) compared with those not on antithrombotics (3%). However, no significant difference in the incidence of bleeding occurred between patients undergoing primary surgery and those undergoing salvage surgery (7% vs. 10%). Bleeding occurred an average of 11 days after surgery.

The bleeding events occurred past the time points when most patients would resume their antithrombotic medications, Dr. Asher noted.

"Our recommendation is that patients taking these meds should receive additional preop counseling when considering a TORS procedure," he said.

"A second recommendation is to collaborate preoperatively with the physicians who are prescribing," as well as the anesthesia team, to closely analyze the indications for use of antithrombotics, Dr. Asher added. "If you can safely discontinue them, you can potentially improve your TORS outcomes," he said.

Additional long-term safety and outcomes data are needed for TORS procedures, said Dr. Asher. "We are constantly reflecting on our own experience," he said. "We would encourage other institutions to collect and publish their complications-related data to continue to improve TORS outcomes."

Dr. Asher said he had no relevant financial conflicts.

[email protected]

The risk of postoperative hemorrhage after transoral robotic-assisted surgery was significantly higher in patients taking antithrombotic medication than in those not taking it, based on data from 147 consecutive patients.

"Even with this small sample size, we were able to identify that increased risk was associated with antithrombotic medication use," said Dr. Scott Asher of the University of Alabama at Birmingham.

Transoral robotic-assisted surgery (TORS) is gaining in popularity among head and neck surgeons, but the potential for postop bleeding in patients taking antithrombotic medication remains a problem, Dr. Asher said at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.

To assess the postop bleeding complications in TORS patients, Dr. Asher and his colleagues reviewed data from patients seen at a single tertiary academic medical center between March 2007 and September 2011.

Overall, 11 patients (8%) experienced some postop hemorrhage, but 8 of these hemorrhages (72%) occurred in patients taking antithrombotics, Dr. Asher said. Nine patients who hemorrhaged returned to the operating room for further examination and bleeding control, he noted. All postop hemorrhage events were controlled with standard techniques.

The incidence of postop hemorrhage was significantly higher among patients on antithrombotics (17%) compared with those not on antithrombotics (3%). However, no significant difference in the incidence of bleeding occurred between patients undergoing primary surgery and those undergoing salvage surgery (7% vs. 10%). Bleeding occurred an average of 11 days after surgery.

The bleeding events occurred past the time points when most patients would resume their antithrombotic medications, Dr. Asher noted.

"Our recommendation is that patients taking these meds should receive additional preop counseling when considering a TORS procedure," he said.

"A second recommendation is to collaborate preoperatively with the physicians who are prescribing," as well as the anesthesia team, to closely analyze the indications for use of antithrombotics, Dr. Asher added. "If you can safely discontinue them, you can potentially improve your TORS outcomes," he said.

Additional long-term safety and outcomes data are needed for TORS procedures, said Dr. Asher. "We are constantly reflecting on our own experience," he said. "We would encourage other institutions to collect and publish their complications-related data to continue to improve TORS outcomes."

Dr. Asher said he had no relevant financial conflicts.

[email protected]

The risk of postoperative hemorrhage after transoral robotic-assisted surgery was significantly higher in patients taking antithrombotic medication than in those not taking it, based on data from 147 consecutive patients.

"Even with this small sample size, we were able to identify that increased risk was associated with antithrombotic medication use," said Dr. Scott Asher of the University of Alabama at Birmingham.

Transoral robotic-assisted surgery (TORS) is gaining in popularity among head and neck surgeons, but the potential for postop bleeding in patients taking antithrombotic medication remains a problem, Dr. Asher said at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.

To assess the postop bleeding complications in TORS patients, Dr. Asher and his colleagues reviewed data from patients seen at a single tertiary academic medical center between March 2007 and September 2011.

Overall, 11 patients (8%) experienced some postop hemorrhage, but 8 of these hemorrhages (72%) occurred in patients taking antithrombotics, Dr. Asher said. Nine patients who hemorrhaged returned to the operating room for further examination and bleeding control, he noted. All postop hemorrhage events were controlled with standard techniques.

The incidence of postop hemorrhage was significantly higher among patients on antithrombotics (17%) compared with those not on antithrombotics (3%). However, no significant difference in the incidence of bleeding occurred between patients undergoing primary surgery and those undergoing salvage surgery (7% vs. 10%). Bleeding occurred an average of 11 days after surgery.

The bleeding events occurred past the time points when most patients would resume their antithrombotic medications, Dr. Asher noted.

"Our recommendation is that patients taking these meds should receive additional preop counseling when considering a TORS procedure," he said.

"A second recommendation is to collaborate preoperatively with the physicians who are prescribing," as well as the anesthesia team, to closely analyze the indications for use of antithrombotics, Dr. Asher added. "If you can safely discontinue them, you can potentially improve your TORS outcomes," he said.

Additional long-term safety and outcomes data are needed for TORS procedures, said Dr. Asher. "We are constantly reflecting on our own experience," he said. "We would encourage other institutions to collect and publish their complications-related data to continue to improve TORS outcomes."

Dr. Asher said he had no relevant financial conflicts.

[email protected]

Statin therapy taken to prevent cardiovascular events also appears to protect against hepatocellular carcinoma, reducing the overall risk for the cancer by 37%, according to the results of a systematic review and meta-analysis.

In a meta-analysis of all the studies in the literature that have examined statins’ effect on HCC risk, use of the drugs was associated with a pronounced and consistent risk reduction (48%) in Asian populations, as well as a still-significant reduction (33%) in Western populations, reported Dr. Siddharth Singh and his associates at the Mayo Clinic, Rochester, Minn.

Video source: American Gastroenterological Association's YouTube page

At present, "it does not seem prudent to prescribe statins for chemoprevention" of HCC in the general population, mainly because of the high number of people who would need to be treated to prevent a single case of HCC. "However, in patients with multiple risk factors, such as East Asian men who have chronic HBV [hepatitis B virus] infection, statins may have a clinically relevant chemoprotective effect against HCC, the investigators said (Gastroenterology 2012 Oct. 15 [doi: 10.1053/j.gastro.2012.10.005]).

Prospective cohort studies or randomized clinical trials of the issue are warranted in populations at high risk for HCC, they noted.

The results of preclinical studies have suggested that statins may decrease the risk of cancers, perhaps because their antiproliferative, proapoptotic, antiangiogenic, immunomodulatory, and anti-infective effects may prevent cancer growth. But clinical studies have produced conflicting results.

Dr. Singh and his colleagues performed a systematic review of the literature for studies that clearly defined statin exposure, reported HCC risk, and either reported relative risks or odds ratios for the development of HCC or provided the data so those risks could be calculated. They then performed a meta-analysis of 10 studies: 7 observational studies and 3 that reported pooled data from 26 randomized clinical trials.

Most of the studies were considered to be of high quality. Most of them accounted for various potential confounders such as patient age; sex; medication use; and the presence of viral hepatitis, cirrhosis, diabetes, or alcoholic liver disease. The likelihood of selection bias and of publication bias in the included studies was judged to be very low.

Altogether the 10 studies included 1,459,417 subjects and 4,298 cases of HCC.

In an initial analysis of the data, the use of statins was associated with a significant 41% reduction in the rate of HCC. After the data were adjusted to account for several potential confounders, the risk reduction was altered slightly, but a robust 37% reduction in HCC rate remained.

The investigators also performed an analysis of the data based on the location of the studies, because the epidemiology of HCC is so different between Western and Asian populations. They found that statin use correlated with a 48% reduction in the rate of HCC in Asian populations, where viral hepatitis is the primary risk factor for the disease, and a 33% reduction in the rate of HCC in Western populations, where the metabolic syndrome, nonalcoholic fatty liver disease, and alcohol-related cirrhosis are the primary risk factors.

The researchers also performed sensitivity analyses according to the studies’ design (cohort vs. case control) and quality (high vs. low). Both cohort and case-control studies confirmed a protective effect of statins against the development of HCC, as did both high-quality and low-quality studies.

In a final sensitivity analysis, each study was serially excluded from the meta-analysis to determine whether any one study was having a dominant effect on the odds ratios. None of the studies was found to markedly affect the outcomes of the analyses.

The study design didn’t permit separate analyses of the protective effects of statins by drug type or by dose or duration of therapy.

The studies included in this meta-analysis were too heterogeneous to allow the investigators to calculate an overall number needed to treat. But the studies restricted to Asian patients were homogeneous and did allow this calculation for men of Asian ethnicity.

Dr. Singh and his associates determined that 5,209 East Asian men would need to be treated with statins to prevent 1 case of HCC per year. For very-high-risk Asian men with chronic HBV-associated cirrhosis, the number needed to treat with statins to prevent 1 case of HCC per year would be 57.

No financial conflicts of interest were reported.

Statin therapy taken to prevent cardiovascular events also appears to protect against hepatocellular carcinoma, reducing the overall risk for the cancer by 37%, according to the results of a systematic review and meta-analysis.

In a meta-analysis of all the studies in the literature that have examined statins’ effect on HCC risk, use of the drugs was associated with a pronounced and consistent risk reduction (48%) in Asian populations, as well as a still-significant reduction (33%) in Western populations, reported Dr. Siddharth Singh and his associates at the Mayo Clinic, Rochester, Minn.

Video source: American Gastroenterological Association's YouTube page

At present, "it does not seem prudent to prescribe statins for chemoprevention" of HCC in the general population, mainly because of the high number of people who would need to be treated to prevent a single case of HCC. "However, in patients with multiple risk factors, such as East Asian men who have chronic HBV [hepatitis B virus] infection, statins may have a clinically relevant chemoprotective effect against HCC, the investigators said (Gastroenterology 2012 Oct. 15 [doi: 10.1053/j.gastro.2012.10.005]).

Prospective cohort studies or randomized clinical trials of the issue are warranted in populations at high risk for HCC, they noted.

The results of preclinical studies have suggested that statins may decrease the risk of cancers, perhaps because their antiproliferative, proapoptotic, antiangiogenic, immunomodulatory, and anti-infective effects may prevent cancer growth. But clinical studies have produced conflicting results.

Dr. Singh and his colleagues performed a systematic review of the literature for studies that clearly defined statin exposure, reported HCC risk, and either reported relative risks or odds ratios for the development of HCC or provided the data so those risks could be calculated. They then performed a meta-analysis of 10 studies: 7 observational studies and 3 that reported pooled data from 26 randomized clinical trials.

Most of the studies were considered to be of high quality. Most of them accounted for various potential confounders such as patient age; sex; medication use; and the presence of viral hepatitis, cirrhosis, diabetes, or alcoholic liver disease. The likelihood of selection bias and of publication bias in the included studies was judged to be very low.

Altogether the 10 studies included 1,459,417 subjects and 4,298 cases of HCC.

In an initial analysis of the data, the use of statins was associated with a significant 41% reduction in the rate of HCC. After the data were adjusted to account for several potential confounders, the risk reduction was altered slightly, but a robust 37% reduction in HCC rate remained.

The investigators also performed an analysis of the data based on the location of the studies, because the epidemiology of HCC is so different between Western and Asian populations. They found that statin use correlated with a 48% reduction in the rate of HCC in Asian populations, where viral hepatitis is the primary risk factor for the disease, and a 33% reduction in the rate of HCC in Western populations, where the metabolic syndrome, nonalcoholic fatty liver disease, and alcohol-related cirrhosis are the primary risk factors.

The researchers also performed sensitivity analyses according to the studies’ design (cohort vs. case control) and quality (high vs. low). Both cohort and case-control studies confirmed a protective effect of statins against the development of HCC, as did both high-quality and low-quality studies.

In a final sensitivity analysis, each study was serially excluded from the meta-analysis to determine whether any one study was having a dominant effect on the odds ratios. None of the studies was found to markedly affect the outcomes of the analyses.

The study design didn’t permit separate analyses of the protective effects of statins by drug type or by dose or duration of therapy.

The studies included in this meta-analysis were too heterogeneous to allow the investigators to calculate an overall number needed to treat. But the studies restricted to Asian patients were homogeneous and did allow this calculation for men of Asian ethnicity.

Dr. Singh and his associates determined that 5,209 East Asian men would need to be treated with statins to prevent 1 case of HCC per year. For very-high-risk Asian men with chronic HBV-associated cirrhosis, the number needed to treat with statins to prevent 1 case of HCC per year would be 57.

No financial conflicts of interest were reported.

Statin therapy taken to prevent cardiovascular events also appears to protect against hepatocellular carcinoma, reducing the overall risk for the cancer by 37%, according to the results of a systematic review and meta-analysis.

In a meta-analysis of all the studies in the literature that have examined statins’ effect on HCC risk, use of the drugs was associated with a pronounced and consistent risk reduction (48%) in Asian populations, as well as a still-significant reduction (33%) in Western populations, reported Dr. Siddharth Singh and his associates at the Mayo Clinic, Rochester, Minn.

Video source: American Gastroenterological Association's YouTube page

At present, "it does not seem prudent to prescribe statins for chemoprevention" of HCC in the general population, mainly because of the high number of people who would need to be treated to prevent a single case of HCC. "However, in patients with multiple risk factors, such as East Asian men who have chronic HBV [hepatitis B virus] infection, statins may have a clinically relevant chemoprotective effect against HCC, the investigators said (Gastroenterology 2012 Oct. 15 [doi: 10.1053/j.gastro.2012.10.005]).

Prospective cohort studies or randomized clinical trials of the issue are warranted in populations at high risk for HCC, they noted.

The results of preclinical studies have suggested that statins may decrease the risk of cancers, perhaps because their antiproliferative, proapoptotic, antiangiogenic, immunomodulatory, and anti-infective effects may prevent cancer growth. But clinical studies have produced conflicting results.

Dr. Singh and his colleagues performed a systematic review of the literature for studies that clearly defined statin exposure, reported HCC risk, and either reported relative risks or odds ratios for the development of HCC or provided the data so those risks could be calculated. They then performed a meta-analysis of 10 studies: 7 observational studies and 3 that reported pooled data from 26 randomized clinical trials.

Most of the studies were considered to be of high quality. Most of them accounted for various potential confounders such as patient age; sex; medication use; and the presence of viral hepatitis, cirrhosis, diabetes, or alcoholic liver disease. The likelihood of selection bias and of publication bias in the included studies was judged to be very low.

Altogether the 10 studies included 1,459,417 subjects and 4,298 cases of HCC.

In an initial analysis of the data, the use of statins was associated with a significant 41% reduction in the rate of HCC. After the data were adjusted to account for several potential confounders, the risk reduction was altered slightly, but a robust 37% reduction in HCC rate remained.

The investigators also performed an analysis of the data based on the location of the studies, because the epidemiology of HCC is so different between Western and Asian populations. They found that statin use correlated with a 48% reduction in the rate of HCC in Asian populations, where viral hepatitis is the primary risk factor for the disease, and a 33% reduction in the rate of HCC in Western populations, where the metabolic syndrome, nonalcoholic fatty liver disease, and alcohol-related cirrhosis are the primary risk factors.

The researchers also performed sensitivity analyses according to the studies’ design (cohort vs. case control) and quality (high vs. low). Both cohort and case-control studies confirmed a protective effect of statins against the development of HCC, as did both high-quality and low-quality studies.

In a final sensitivity analysis, each study was serially excluded from the meta-analysis to determine whether any one study was having a dominant effect on the odds ratios. None of the studies was found to markedly affect the outcomes of the analyses.

The study design didn’t permit separate analyses of the protective effects of statins by drug type or by dose or duration of therapy.

The studies included in this meta-analysis were too heterogeneous to allow the investigators to calculate an overall number needed to treat. But the studies restricted to Asian patients were homogeneous and did allow this calculation for men of Asian ethnicity.

Dr. Singh and his associates determined that 5,209 East Asian men would need to be treated with statins to prevent 1 case of HCC per year. For very-high-risk Asian men with chronic HBV-associated cirrhosis, the number needed to treat with statins to prevent 1 case of HCC per year would be 57.

No financial conflicts of interest were reported.

A 56-year-old Hispanic female with a past medical history significant for basal cell carcinoma presented with a history of itchy, erythematous papules on her right cheek. Four days prior, she presented for suture removal after reconstruction with an island pedicle flap following Mohs micrographic surgery. She experienced a similar rash on her forearm following another surgery in the past.

a) Cellulitis

b) Contact dermatitis

c) Herpes simplex virus

Diagnosis: Contact dermatitis secondary to Mastisol and Steri-Strips

Courtesy Dr. Keyvan Nouri

Contact dermatitis is a localized, pruritic, erythematous rash that occurs after contact with a certain allergen or irritant. The disorder is typically classified as either allergic contact dermatitis or irritant contact dermatitis.

Allergic contact dermatitis is a T cell–mediated, type-IV, delayed-type hypersensitivity reaction that requires prior sensitization with the causative agent before the patient becomes allergic to it. The typical rash of pruritus, erythema, edema, and vesicle formation occurs with further exposures.

The mechanism of immune response to a particular allergen requires that the antigen be of low molecular weight (less than 500 d) in order to penetrate the stratum corneum and gain access to the immunologic system. CD4, CD8, T regulatory cells, and natural killer T cells have all been implicated.

The process is composed of an afferent (sensitization) phase and an efferent (elicitation) phase.

Common haptens or immunogenic agents include nickel, urushiol from poison ivy resin, ultraviolet light, dyes, and fragrances.

This patient revealed a history of a similar reaction to the one presented in this case following wound dressing on her forearm with two products: Steri-Strips and Mastisol liquid adhesive. Unfortunately, she did not reveal this history until she had experienced the reaction a second time. The patient was instructed to apply hydrocortisone 1% cream twice daily to the red areas only and to follow up with a clinic visit in 4-5 days. Documentation of her allergy was included in her medical record.

This case was submitted by Dr. Keyvan Nouri; Dr. Katlein Franca; Jennifer Ledon; and Jessica Savas of the University of Miami.

–Donna Bilu Martin, M.D.

A 56-year-old Hispanic female with a past medical history significant for basal cell carcinoma presented with a history of itchy, erythematous papules on her right cheek. Four days prior, she presented for suture removal after reconstruction with an island pedicle flap following Mohs micrographic surgery. She experienced a similar rash on her forearm following another surgery in the past.

a) Cellulitis

b) Contact dermatitis

c) Herpes simplex virus

Diagnosis: Contact dermatitis secondary to Mastisol and Steri-Strips

Courtesy Dr. Keyvan Nouri

Contact dermatitis is a localized, pruritic, erythematous rash that occurs after contact with a certain allergen or irritant. The disorder is typically classified as either allergic contact dermatitis or irritant contact dermatitis.

Allergic contact dermatitis is a T cell–mediated, type-IV, delayed-type hypersensitivity reaction that requires prior sensitization with the causative agent before the patient becomes allergic to it. The typical rash of pruritus, erythema, edema, and vesicle formation occurs with further exposures.

The mechanism of immune response to a particular allergen requires that the antigen be of low molecular weight (less than 500 d) in order to penetrate the stratum corneum and gain access to the immunologic system. CD4, CD8, T regulatory cells, and natural killer T cells have all been implicated.

The process is composed of an afferent (sensitization) phase and an efferent (elicitation) phase.

Common haptens or immunogenic agents include nickel, urushiol from poison ivy resin, ultraviolet light, dyes, and fragrances.

This patient revealed a history of a similar reaction to the one presented in this case following wound dressing on her forearm with two products: Steri-Strips and Mastisol liquid adhesive. Unfortunately, she did not reveal this history until she had experienced the reaction a second time. The patient was instructed to apply hydrocortisone 1% cream twice daily to the red areas only and to follow up with a clinic visit in 4-5 days. Documentation of her allergy was included in her medical record.

This case was submitted by Dr. Keyvan Nouri; Dr. Katlein Franca; Jennifer Ledon; and Jessica Savas of the University of Miami.

–Donna Bilu Martin, M.D.

A 56-year-old Hispanic female with a past medical history significant for basal cell carcinoma presented with a history of itchy, erythematous papules on her right cheek. Four days prior, she presented for suture removal after reconstruction with an island pedicle flap following Mohs micrographic surgery. She experienced a similar rash on her forearm following another surgery in the past.

a) Cellulitis

b) Contact dermatitis

c) Herpes simplex virus

Diagnosis: Contact dermatitis secondary to Mastisol and Steri-Strips

Courtesy Dr. Keyvan Nouri

Contact dermatitis is a localized, pruritic, erythematous rash that occurs after contact with a certain allergen or irritant. The disorder is typically classified as either allergic contact dermatitis or irritant contact dermatitis.

Allergic contact dermatitis is a T cell–mediated, type-IV, delayed-type hypersensitivity reaction that requires prior sensitization with the causative agent before the patient becomes allergic to it. The typical rash of pruritus, erythema, edema, and vesicle formation occurs with further exposures.

The mechanism of immune response to a particular allergen requires that the antigen be of low molecular weight (less than 500 d) in order to penetrate the stratum corneum and gain access to the immunologic system. CD4, CD8, T regulatory cells, and natural killer T cells have all been implicated.

The process is composed of an afferent (sensitization) phase and an efferent (elicitation) phase.

Common haptens or immunogenic agents include nickel, urushiol from poison ivy resin, ultraviolet light, dyes, and fragrances.

This patient revealed a history of a similar reaction to the one presented in this case following wound dressing on her forearm with two products: Steri-Strips and Mastisol liquid adhesive. Unfortunately, she did not reveal this history until she had experienced the reaction a second time. The patient was instructed to apply hydrocortisone 1% cream twice daily to the red areas only and to follow up with a clinic visit in 4-5 days. Documentation of her allergy was included in her medical record.

This case was submitted by Dr. Keyvan Nouri; Dr. Katlein Franca; Jennifer Ledon; and Jessica Savas of the University of Miami.

–Donna Bilu Martin, M.D.

Plasma for donation

The FDA has approved a pooled plasma blood product (Octaplas) that can be used to replace coagulation factors in patients with certain medical conditions.

The product is a sterile, frozen solution of human plasma from several donors that has been treated with a solvent detergent process to minimize the risk of serious virus transmission.

The plasma used to manufacture Octaplas is collected from US donors who have been screened and tested for diseases transmitted by blood.

“For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma [FFP] and provides a reduced risk of certain viral transmissions,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Indications and administration

Octaplas is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant. Octaplas can also be

used for plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

Like FFP, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. Each lot of Octaplas is tested for composition of key clotting factors and is only released if the levels are within acceptable ranges.

The product is administered by intravenous infusion after thawing, using an infusion set with a filter. An aseptic technique must be used throughout the infusion.

The dosage depends upon the clinical situation and the underlying disorder. But 12-15 mL/kg of body weight is a generally accepted starting dose, and it should increase the patient’s plasma coagulation factor levels by about 25%.

It is important to monitor patient response, both clinically and with measurement of prothrombin time, partial thromboplastin time, and/or specific coagulation factor assays.

Prior experience with Octaplas

The FDA’s approval of Octaplas was primarily based on studies conducted in patients with liver disease, liver transplant, heart surgery, and TTP. The most common adverse reactions observed in these trials were shortness of breath, dizziness, chest discomfort, pruritis/rash, headache, and paresthesia.

Additional data supporting the safe use of Octaplas for the US market came from prior use of the product in Europe and other approved markets, where it has been used extensively.

A previous generation of Octaplas was first marketed in 1992, and the current version has been marketed since 2006. In total, more than 2 million patients outside the US have been treated with more than 7 million doses of Octaplas.

The product is manufactured by Octapharma, located in Vienna, Austria. For more information on Octaplas, visit the Octapharma website.

Plasma for donation

The FDA has approved a pooled plasma blood product (Octaplas) that can be used to replace coagulation factors in patients with certain medical conditions.

The product is a sterile, frozen solution of human plasma from several donors that has been treated with a solvent detergent process to minimize the risk of serious virus transmission.

The plasma used to manufacture Octaplas is collected from US donors who have been screened and tested for diseases transmitted by blood.

“For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma [FFP] and provides a reduced risk of certain viral transmissions,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Indications and administration

Octaplas is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant. Octaplas can also be

used for plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

Like FFP, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. Each lot of Octaplas is tested for composition of key clotting factors and is only released if the levels are within acceptable ranges.

The product is administered by intravenous infusion after thawing, using an infusion set with a filter. An aseptic technique must be used throughout the infusion.

The dosage depends upon the clinical situation and the underlying disorder. But 12-15 mL/kg of body weight is a generally accepted starting dose, and it should increase the patient’s plasma coagulation factor levels by about 25%.

It is important to monitor patient response, both clinically and with measurement of prothrombin time, partial thromboplastin time, and/or specific coagulation factor assays.

Prior experience with Octaplas

The FDA’s approval of Octaplas was primarily based on studies conducted in patients with liver disease, liver transplant, heart surgery, and TTP. The most common adverse reactions observed in these trials were shortness of breath, dizziness, chest discomfort, pruritis/rash, headache, and paresthesia.

Additional data supporting the safe use of Octaplas for the US market came from prior use of the product in Europe and other approved markets, where it has been used extensively.

A previous generation of Octaplas was first marketed in 1992, and the current version has been marketed since 2006. In total, more than 2 million patients outside the US have been treated with more than 7 million doses of Octaplas.

The product is manufactured by Octapharma, located in Vienna, Austria. For more information on Octaplas, visit the Octapharma website.

Plasma for donation

The FDA has approved a pooled plasma blood product (Octaplas) that can be used to replace coagulation factors in patients with certain medical conditions.

The product is a sterile, frozen solution of human plasma from several donors that has been treated with a solvent detergent process to minimize the risk of serious virus transmission.

The plasma used to manufacture Octaplas is collected from US donors who have been screened and tested for diseases transmitted by blood.

“For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma [FFP] and provides a reduced risk of certain viral transmissions,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Indications and administration

Octaplas is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant. Octaplas can also be

used for plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

Like FFP, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. Each lot of Octaplas is tested for composition of key clotting factors and is only released if the levels are within acceptable ranges.

The product is administered by intravenous infusion after thawing, using an infusion set with a filter. An aseptic technique must be used throughout the infusion.

The dosage depends upon the clinical situation and the underlying disorder. But 12-15 mL/kg of body weight is a generally accepted starting dose, and it should increase the patient’s plasma coagulation factor levels by about 25%.

It is important to monitor patient response, both clinically and with measurement of prothrombin time, partial thromboplastin time, and/or specific coagulation factor assays.

Prior experience with Octaplas

The FDA’s approval of Octaplas was primarily based on studies conducted in patients with liver disease, liver transplant, heart surgery, and TTP. The most common adverse reactions observed in these trials were shortness of breath, dizziness, chest discomfort, pruritis/rash, headache, and paresthesia.

Additional data supporting the safe use of Octaplas for the US market came from prior use of the product in Europe and other approved markets, where it has been used extensively.

A previous generation of Octaplas was first marketed in 1992, and the current version has been marketed since 2006. In total, more than 2 million patients outside the US have been treated with more than 7 million doses of Octaplas.

The product is manufactured by Octapharma, located in Vienna, Austria. For more information on Octaplas, visit the Octapharma website.