The Food and Drug Administration has concluded that a long-term cardiovascular outcome study is necessary to determine the cardiovascular safety of weight loss drug Qnexa (phentermine/topiramate) – and the agency is asking the Endocrinologic and Metabolic Drugs Advisory Committee Feb. 22 for input on whether the study should be conducted before or after approval.

Studies of the drug to date have involved mostly overweight and obese patients with low to moderate baseline cardiovascular (CV) risk, the agency explained in briefing documents for the meeting. As a result, the agency concluded, "it is unknown what the clinical significance of [phentermine/topiramate’s] cardiovascular effects and metabolic effects will be in a higher-risk cardiovascular population with chronic treatment."

Because of that, the agency concluded that "only a long-term, cardiovascular outcome trial can define the effect of [phentermine/topiramate’s] treatment on risk for major adverse cardiovascular events in an obese at-risk population."

When such a trial should be conducted is a discussion question for the panel.

Uncertainty about the cardiovascular safety of Vivus’s Qnexa contributed to a 10-6 vote against approval of the drug when it last went before the advisory committee in 2010.

Twelve of the 16 voting members from that panel will consider Qnexa this time around as well, according to the draft roster for the meeting. Six of the returnees voted in favor of approval in 2010 and six voted no. They will be joined by 10 new voting members.

Contrave CV Study Could Be a Clue

Even if the panel indicates that a postapproval cardiovascular study would be acceptable, that does not guarantee that the FDA will go along.

The agency directed Orexigen Therapeutics to study CV risk in Contrave, a combination of naltrexone and bupropion, in a preapproval trial, although an advisory panel voted 13-7 in favor of approving the drug. The committee voted 11-8, with 1 abstention, that a postmarketing CV trial would be acceptable.

After first announcing it would discontinue development of Contrave, Orexigen reached an agreement with the agency to move forward with an outcomes trial, under a special protocol assessment.

The study, as outlined by Orexigen, provides a glimpse into FDA thinking on what it currently is willing to accept in terms of CV safety in weight loss drugs. The Contrave trial is to enroll 10,000 patients overall, with an estimated background rate of 1%-1.5% annual risk of major cardiovascular events. An interim analysis can be conducted when 87 major adverse CV events occur and serve as the basis for re-filing the Contrave new drug application. The company expects that to come within 2 years and after an enrollment of 7,000.

As for the acceptable risk threshold, the agreement on the Contrave trial is that the upper bound of the 95% confidence interval should exclude those with a risk of 2.0 at the interim and 1.4 at the final analysis. Any patient who does not achieve a predefined weight loss goal after 16 weeks of treatment will discontinue Contrave therapy.

Guidance for diabetes drugs calls on sponsors to exclude an 80% or higher increased risk of CV events before approval. Postapproval CV outcomes trials may be necessary if the risk ratio from a meta-analysis of phase II and phase III studies is between 1.3 and 1.8, but may not be required if the risk ratio is below 1.3.

Some members of the panel that reviewed Abbott Laboratories’ Meridia (sibutramine) in 2010 suggested that sponsors be required to rule out an unacceptable level of CV risk for investigational weight loss drugs similar to that for the diabetes treatments.

Advisory committee members pushed for obesity CV guidance throughout their 2010 reviews of four weight loss drugs, which also included Arena Pharmaceuticals’ Lorqess (lorcaserin).

A March 28-29 advisory committee on CV risk in obesity drugs will give panel members an opportunity to weigh in on an acceptable risk and should provide an indication of whether the FDA leans toward the risk level set out in the Contrave trial protocol or in the diabetes guidance.

One of the factors that prompted Orexigen to proceed with its study was the FDA’s agreement that any changes in its expectations with regard to CV safety for weight loss drugs would not affect how the agency will assess results from the Contrave study.

REMS for Teratogenicity Up for Debate

The potential teratogenicity of the topiramate component of Contrave was another factor in the "complete response" letter for the drug, but this issue seems more resolved than the cardiovascular safety issue. The company initially resubmitted for an indication excluding women of childbearing potential, but the FDA said a contraindication against women who are pregnant is sufficient.

Teratogenicity will be discussed at the committee review. The briefing materials note that preliminary results from three studies conducted since the previous advisory committee meeting "were consistent in demonstrating a lack of association between topiramate exposure and risk of major congenital malformations."

However, the agency points out that "depending on the analysis, topiramate monotherapy exposure in pregnancy is likely to be associated with a two- to fivefold increased prevalence of oral clefts."

The FDA is asking the committee to consider the risk of oral clefts in babies born to women taking topiramate and a proposed Qnexa risk evaluation and mitigation strategy (REMS).

The agency has proposed and the company has agreed to a REMS that includes certification of pharmacies that dispense the drug and voluntary training of health care providers to support their risk/benefit discussions with women of childbearing potential.

Certified pharmacies would be required to remind women of childbearing potential to use contraception and to test for pregnancy. The drug could be shipped directly to the patients or to a nearby pharmacy for pickup.

The FDA’s division of risk management suggested that restricted distribution of Qnexa with mandatory pregnancy testing would have limited impact because the same restrictions are not required when topiramate is used for seizures or migraine prophylaxis. Doctors also could bypass the REMS by prescribing the topiramate and phentermine individually, the division noted.

The impact on other topiramate prescriptions was a factor for the agency. To impose the same restrictions on topiramate used for epilepsy and migraine would impose an undue burden for patients with those conditions, the division said.

Elsevier Global Medical News and "The Pink Sheet" are published by Elsevier.

The Food and Drug Administration has concluded that a long-term cardiovascular outcome study is necessary to determine the cardiovascular safety of weight loss drug Qnexa (phentermine/topiramate) – and the agency is asking the Endocrinologic and Metabolic Drugs Advisory Committee Feb. 22 for input on whether the study should be conducted before or after approval.

Studies of the drug to date have involved mostly overweight and obese patients with low to moderate baseline cardiovascular (CV) risk, the agency explained in briefing documents for the meeting. As a result, the agency concluded, "it is unknown what the clinical significance of [phentermine/topiramate’s] cardiovascular effects and metabolic effects will be in a higher-risk cardiovascular population with chronic treatment."

Because of that, the agency concluded that "only a long-term, cardiovascular outcome trial can define the effect of [phentermine/topiramate’s] treatment on risk for major adverse cardiovascular events in an obese at-risk population."

When such a trial should be conducted is a discussion question for the panel.

Uncertainty about the cardiovascular safety of Vivus’s Qnexa contributed to a 10-6 vote against approval of the drug when it last went before the advisory committee in 2010.

Twelve of the 16 voting members from that panel will consider Qnexa this time around as well, according to the draft roster for the meeting. Six of the returnees voted in favor of approval in 2010 and six voted no. They will be joined by 10 new voting members.

Contrave CV Study Could Be a Clue

Even if the panel indicates that a postapproval cardiovascular study would be acceptable, that does not guarantee that the FDA will go along.

The agency directed Orexigen Therapeutics to study CV risk in Contrave, a combination of naltrexone and bupropion, in a preapproval trial, although an advisory panel voted 13-7 in favor of approving the drug. The committee voted 11-8, with 1 abstention, that a postmarketing CV trial would be acceptable.

After first announcing it would discontinue development of Contrave, Orexigen reached an agreement with the agency to move forward with an outcomes trial, under a special protocol assessment.

The study, as outlined by Orexigen, provides a glimpse into FDA thinking on what it currently is willing to accept in terms of CV safety in weight loss drugs. The Contrave trial is to enroll 10,000 patients overall, with an estimated background rate of 1%-1.5% annual risk of major cardiovascular events. An interim analysis can be conducted when 87 major adverse CV events occur and serve as the basis for re-filing the Contrave new drug application. The company expects that to come within 2 years and after an enrollment of 7,000.

As for the acceptable risk threshold, the agreement on the Contrave trial is that the upper bound of the 95% confidence interval should exclude those with a risk of 2.0 at the interim and 1.4 at the final analysis. Any patient who does not achieve a predefined weight loss goal after 16 weeks of treatment will discontinue Contrave therapy.

Guidance for diabetes drugs calls on sponsors to exclude an 80% or higher increased risk of CV events before approval. Postapproval CV outcomes trials may be necessary if the risk ratio from a meta-analysis of phase II and phase III studies is between 1.3 and 1.8, but may not be required if the risk ratio is below 1.3.

Some members of the panel that reviewed Abbott Laboratories’ Meridia (sibutramine) in 2010 suggested that sponsors be required to rule out an unacceptable level of CV risk for investigational weight loss drugs similar to that for the diabetes treatments.

Advisory committee members pushed for obesity CV guidance throughout their 2010 reviews of four weight loss drugs, which also included Arena Pharmaceuticals’ Lorqess (lorcaserin).

A March 28-29 advisory committee on CV risk in obesity drugs will give panel members an opportunity to weigh in on an acceptable risk and should provide an indication of whether the FDA leans toward the risk level set out in the Contrave trial protocol or in the diabetes guidance.

One of the factors that prompted Orexigen to proceed with its study was the FDA’s agreement that any changes in its expectations with regard to CV safety for weight loss drugs would not affect how the agency will assess results from the Contrave study.

REMS for Teratogenicity Up for Debate

The potential teratogenicity of the topiramate component of Contrave was another factor in the "complete response" letter for the drug, but this issue seems more resolved than the cardiovascular safety issue. The company initially resubmitted for an indication excluding women of childbearing potential, but the FDA said a contraindication against women who are pregnant is sufficient.

Teratogenicity will be discussed at the committee review. The briefing materials note that preliminary results from three studies conducted since the previous advisory committee meeting "were consistent in demonstrating a lack of association between topiramate exposure and risk of major congenital malformations."

However, the agency points out that "depending on the analysis, topiramate monotherapy exposure in pregnancy is likely to be associated with a two- to fivefold increased prevalence of oral clefts."

The FDA is asking the committee to consider the risk of oral clefts in babies born to women taking topiramate and a proposed Qnexa risk evaluation and mitigation strategy (REMS).

The agency has proposed and the company has agreed to a REMS that includes certification of pharmacies that dispense the drug and voluntary training of health care providers to support their risk/benefit discussions with women of childbearing potential.

Certified pharmacies would be required to remind women of childbearing potential to use contraception and to test for pregnancy. The drug could be shipped directly to the patients or to a nearby pharmacy for pickup.

The FDA’s division of risk management suggested that restricted distribution of Qnexa with mandatory pregnancy testing would have limited impact because the same restrictions are not required when topiramate is used for seizures or migraine prophylaxis. Doctors also could bypass the REMS by prescribing the topiramate and phentermine individually, the division noted.

The impact on other topiramate prescriptions was a factor for the agency. To impose the same restrictions on topiramate used for epilepsy and migraine would impose an undue burden for patients with those conditions, the division said.

Elsevier Global Medical News and "The Pink Sheet" are published by Elsevier.

The Food and Drug Administration has concluded that a long-term cardiovascular outcome study is necessary to determine the cardiovascular safety of weight loss drug Qnexa (phentermine/topiramate) – and the agency is asking the Endocrinologic and Metabolic Drugs Advisory Committee Feb. 22 for input on whether the study should be conducted before or after approval.

Studies of the drug to date have involved mostly overweight and obese patients with low to moderate baseline cardiovascular (CV) risk, the agency explained in briefing documents for the meeting. As a result, the agency concluded, "it is unknown what the clinical significance of [phentermine/topiramate’s] cardiovascular effects and metabolic effects will be in a higher-risk cardiovascular population with chronic treatment."

Because of that, the agency concluded that "only a long-term, cardiovascular outcome trial can define the effect of [phentermine/topiramate’s] treatment on risk for major adverse cardiovascular events in an obese at-risk population."

When such a trial should be conducted is a discussion question for the panel.

Uncertainty about the cardiovascular safety of Vivus’s Qnexa contributed to a 10-6 vote against approval of the drug when it last went before the advisory committee in 2010.

Twelve of the 16 voting members from that panel will consider Qnexa this time around as well, according to the draft roster for the meeting. Six of the returnees voted in favor of approval in 2010 and six voted no. They will be joined by 10 new voting members.

Contrave CV Study Could Be a Clue

Even if the panel indicates that a postapproval cardiovascular study would be acceptable, that does not guarantee that the FDA will go along.

The agency directed Orexigen Therapeutics to study CV risk in Contrave, a combination of naltrexone and bupropion, in a preapproval trial, although an advisory panel voted 13-7 in favor of approving the drug. The committee voted 11-8, with 1 abstention, that a postmarketing CV trial would be acceptable.

After first announcing it would discontinue development of Contrave, Orexigen reached an agreement with the agency to move forward with an outcomes trial, under a special protocol assessment.

The study, as outlined by Orexigen, provides a glimpse into FDA thinking on what it currently is willing to accept in terms of CV safety in weight loss drugs. The Contrave trial is to enroll 10,000 patients overall, with an estimated background rate of 1%-1.5% annual risk of major cardiovascular events. An interim analysis can be conducted when 87 major adverse CV events occur and serve as the basis for re-filing the Contrave new drug application. The company expects that to come within 2 years and after an enrollment of 7,000.

As for the acceptable risk threshold, the agreement on the Contrave trial is that the upper bound of the 95% confidence interval should exclude those with a risk of 2.0 at the interim and 1.4 at the final analysis. Any patient who does not achieve a predefined weight loss goal after 16 weeks of treatment will discontinue Contrave therapy.

Guidance for diabetes drugs calls on sponsors to exclude an 80% or higher increased risk of CV events before approval. Postapproval CV outcomes trials may be necessary if the risk ratio from a meta-analysis of phase II and phase III studies is between 1.3 and 1.8, but may not be required if the risk ratio is below 1.3.

Some members of the panel that reviewed Abbott Laboratories’ Meridia (sibutramine) in 2010 suggested that sponsors be required to rule out an unacceptable level of CV risk for investigational weight loss drugs similar to that for the diabetes treatments.

Advisory committee members pushed for obesity CV guidance throughout their 2010 reviews of four weight loss drugs, which also included Arena Pharmaceuticals’ Lorqess (lorcaserin).

A March 28-29 advisory committee on CV risk in obesity drugs will give panel members an opportunity to weigh in on an acceptable risk and should provide an indication of whether the FDA leans toward the risk level set out in the Contrave trial protocol or in the diabetes guidance.

One of the factors that prompted Orexigen to proceed with its study was the FDA’s agreement that any changes in its expectations with regard to CV safety for weight loss drugs would not affect how the agency will assess results from the Contrave study.

REMS for Teratogenicity Up for Debate

The potential teratogenicity of the topiramate component of Contrave was another factor in the "complete response" letter for the drug, but this issue seems more resolved than the cardiovascular safety issue. The company initially resubmitted for an indication excluding women of childbearing potential, but the FDA said a contraindication against women who are pregnant is sufficient.

Teratogenicity will be discussed at the committee review. The briefing materials note that preliminary results from three studies conducted since the previous advisory committee meeting "were consistent in demonstrating a lack of association between topiramate exposure and risk of major congenital malformations."

However, the agency points out that "depending on the analysis, topiramate monotherapy exposure in pregnancy is likely to be associated with a two- to fivefold increased prevalence of oral clefts."

The FDA is asking the committee to consider the risk of oral clefts in babies born to women taking topiramate and a proposed Qnexa risk evaluation and mitigation strategy (REMS).

The agency has proposed and the company has agreed to a REMS that includes certification of pharmacies that dispense the drug and voluntary training of health care providers to support their risk/benefit discussions with women of childbearing potential.

Certified pharmacies would be required to remind women of childbearing potential to use contraception and to test for pregnancy. The drug could be shipped directly to the patients or to a nearby pharmacy for pickup.

The FDA’s division of risk management suggested that restricted distribution of Qnexa with mandatory pregnancy testing would have limited impact because the same restrictions are not required when topiramate is used for seizures or migraine prophylaxis. Doctors also could bypass the REMS by prescribing the topiramate and phentermine individually, the division noted.

The impact on other topiramate prescriptions was a factor for the agency. To impose the same restrictions on topiramate used for epilepsy and migraine would impose an undue burden for patients with those conditions, the division said.

Elsevier Global Medical News and "The Pink Sheet" are published by Elsevier.

First be on the lookout for an adolescent girl in your practice who might have the "female athletic triad," which is characterized by disordered eating, amenorrhea, and osteoporosis.

Many girls are involved in sports these days, which is fantastic. But there are some girls and/or their families or coaches who take training to the extreme. Some patients are driven to be the best in their sport or to win an athletic scholarship, whether it’s in track, ice skating, or gymnastics. Some of these girls purposely do not eat right and develop disordered eating to maintain a body weight that they believe is optimal for their sport.

Maintain a high index of clinical suspicion. Adolescence is a crucial time of bone and body development, a time when healthy girls reach their optimal adult height. A really important message to deliver to your athletic patients is that a negative energy balance – that is really what this is about – puts their body and health at risk.

A simple way to start screening for the female athletic triad is to ask all adolescent girls about their periods. Inquire during each visit, whether it’s an annual checkup or routine physical examination. Consider further evaluation if she reports any recent menstrual changes. The benefits of such a screening go beyond diagnosis of the triad – a regular period every month really connotes health in many ways.

If a girl is not getting her period at all, rule out an endocrinologic problem. Girls who have a hyperactive thyroid might not have regular periods and can lose a lot of weight because their bodies are hypermetabolic. So keep this and other endocrinologic disorders in your differential diagnosis of the female athletic triad.

A comprehensive nutrition and exercise history is essential. Ask your patient to complete a 24-hour diet recall. When you take an exercise history, determine exactly what the adolescent girl is doing. Is she training for a specific event? How frequently does she train and for how long?

Once you diagnose female athletic triad in a patient, you can perform her medical management if you feel comfortable doing so. Generally there is a team approach. I often refer patients to a nutritionist – ideally a sports nutritionist – and consider a mental health referral for some girls.

A nutrition specialist can provide general counseling about why the girl has to eat right to maintain her body in a healthy way. Most of the time these patients do not have a sense of what they need to eat to maintain caloric intake and prevent significant weight loss and subsequent amenorrhea. In some cases, patients will report frequent fainting following their weight loss.

You can also refer your patient to an adolescent medicine specialist, who, in some cases, can address the nutritional aspects as well. A consult also can evaluate your patient for risk of anorexia nervosa, particularly if she has lost a tremendous amount of weight.

When you counsel these girls, particularly if they seem reluctant to change their diet or cut back on training, warn them about the long-term risk for osteoporosis. While it’s true that most adolescents with the female athletic triad do not have frank osteoporosis, they might have osteopenia and be at elevated risk for osteoporosis in the future. The few patients who do have osteoporosis often experience bone fractures, even during the teenage years.

Although risk of osteopenia and osteoporosis is part of the triad, I generally don’t order a DXA scan unless a girl has a history of fractures or has missed her periods for close to 1 year. Maintaining proper intake of calcium and vitamin D is important for bone health, and strength exercises also help.

Many girls need supplementation of vitamin D, so obtaining a level might guide treatment. Calcium supplementation also is important because dietary intake is generally not sufficient.

Dr. Alderman is an adolescent medicine specialist at the Children’s Hospital at Montefiore and professor of clinical pediatrics at Albert Einstein College of Medicine, both in New York. She said she had no relevant financial disclosures.

First be on the lookout for an adolescent girl in your practice who might have the "female athletic triad," which is characterized by disordered eating, amenorrhea, and osteoporosis.

Many girls are involved in sports these days, which is fantastic. But there are some girls and/or their families or coaches who take training to the extreme. Some patients are driven to be the best in their sport or to win an athletic scholarship, whether it’s in track, ice skating, or gymnastics. Some of these girls purposely do not eat right and develop disordered eating to maintain a body weight that they believe is optimal for their sport.

Maintain a high index of clinical suspicion. Adolescence is a crucial time of bone and body development, a time when healthy girls reach their optimal adult height. A really important message to deliver to your athletic patients is that a negative energy balance – that is really what this is about – puts their body and health at risk.

A simple way to start screening for the female athletic triad is to ask all adolescent girls about their periods. Inquire during each visit, whether it’s an annual checkup or routine physical examination. Consider further evaluation if she reports any recent menstrual changes. The benefits of such a screening go beyond diagnosis of the triad – a regular period every month really connotes health in many ways.

If a girl is not getting her period at all, rule out an endocrinologic problem. Girls who have a hyperactive thyroid might not have regular periods and can lose a lot of weight because their bodies are hypermetabolic. So keep this and other endocrinologic disorders in your differential diagnosis of the female athletic triad.

A comprehensive nutrition and exercise history is essential. Ask your patient to complete a 24-hour diet recall. When you take an exercise history, determine exactly what the adolescent girl is doing. Is she training for a specific event? How frequently does she train and for how long?

Once you diagnose female athletic triad in a patient, you can perform her medical management if you feel comfortable doing so. Generally there is a team approach. I often refer patients to a nutritionist – ideally a sports nutritionist – and consider a mental health referral for some girls.

A nutrition specialist can provide general counseling about why the girl has to eat right to maintain her body in a healthy way. Most of the time these patients do not have a sense of what they need to eat to maintain caloric intake and prevent significant weight loss and subsequent amenorrhea. In some cases, patients will report frequent fainting following their weight loss.

You can also refer your patient to an adolescent medicine specialist, who, in some cases, can address the nutritional aspects as well. A consult also can evaluate your patient for risk of anorexia nervosa, particularly if she has lost a tremendous amount of weight.

When you counsel these girls, particularly if they seem reluctant to change their diet or cut back on training, warn them about the long-term risk for osteoporosis. While it’s true that most adolescents with the female athletic triad do not have frank osteoporosis, they might have osteopenia and be at elevated risk for osteoporosis in the future. The few patients who do have osteoporosis often experience bone fractures, even during the teenage years.

Although risk of osteopenia and osteoporosis is part of the triad, I generally don’t order a DXA scan unless a girl has a history of fractures or has missed her periods for close to 1 year. Maintaining proper intake of calcium and vitamin D is important for bone health, and strength exercises also help.

Many girls need supplementation of vitamin D, so obtaining a level might guide treatment. Calcium supplementation also is important because dietary intake is generally not sufficient.

Dr. Alderman is an adolescent medicine specialist at the Children’s Hospital at Montefiore and professor of clinical pediatrics at Albert Einstein College of Medicine, both in New York. She said she had no relevant financial disclosures.

First be on the lookout for an adolescent girl in your practice who might have the "female athletic triad," which is characterized by disordered eating, amenorrhea, and osteoporosis.

Many girls are involved in sports these days, which is fantastic. But there are some girls and/or their families or coaches who take training to the extreme. Some patients are driven to be the best in their sport or to win an athletic scholarship, whether it’s in track, ice skating, or gymnastics. Some of these girls purposely do not eat right and develop disordered eating to maintain a body weight that they believe is optimal for their sport.

Maintain a high index of clinical suspicion. Adolescence is a crucial time of bone and body development, a time when healthy girls reach their optimal adult height. A really important message to deliver to your athletic patients is that a negative energy balance – that is really what this is about – puts their body and health at risk.

A simple way to start screening for the female athletic triad is to ask all adolescent girls about their periods. Inquire during each visit, whether it’s an annual checkup or routine physical examination. Consider further evaluation if she reports any recent menstrual changes. The benefits of such a screening go beyond diagnosis of the triad – a regular period every month really connotes health in many ways.

If a girl is not getting her period at all, rule out an endocrinologic problem. Girls who have a hyperactive thyroid might not have regular periods and can lose a lot of weight because their bodies are hypermetabolic. So keep this and other endocrinologic disorders in your differential diagnosis of the female athletic triad.

A comprehensive nutrition and exercise history is essential. Ask your patient to complete a 24-hour diet recall. When you take an exercise history, determine exactly what the adolescent girl is doing. Is she training for a specific event? How frequently does she train and for how long?

Once you diagnose female athletic triad in a patient, you can perform her medical management if you feel comfortable doing so. Generally there is a team approach. I often refer patients to a nutritionist – ideally a sports nutritionist – and consider a mental health referral for some girls.

A nutrition specialist can provide general counseling about why the girl has to eat right to maintain her body in a healthy way. Most of the time these patients do not have a sense of what they need to eat to maintain caloric intake and prevent significant weight loss and subsequent amenorrhea. In some cases, patients will report frequent fainting following their weight loss.

You can also refer your patient to an adolescent medicine specialist, who, in some cases, can address the nutritional aspects as well. A consult also can evaluate your patient for risk of anorexia nervosa, particularly if she has lost a tremendous amount of weight.

When you counsel these girls, particularly if they seem reluctant to change their diet or cut back on training, warn them about the long-term risk for osteoporosis. While it’s true that most adolescents with the female athletic triad do not have frank osteoporosis, they might have osteopenia and be at elevated risk for osteoporosis in the future. The few patients who do have osteoporosis often experience bone fractures, even during the teenage years.

Although risk of osteopenia and osteoporosis is part of the triad, I generally don’t order a DXA scan unless a girl has a history of fractures or has missed her periods for close to 1 year. Maintaining proper intake of calcium and vitamin D is important for bone health, and strength exercises also help.

Many girls need supplementation of vitamin D, so obtaining a level might guide treatment. Calcium supplementation also is important because dietary intake is generally not sufficient.

Dr. Alderman is an adolescent medicine specialist at the Children’s Hospital at Montefiore and professor of clinical pediatrics at Albert Einstein College of Medicine, both in New York. She said she had no relevant financial disclosures.

STEAMBOAT SPRINGS, COLO. – A big bottle of mineral oil is well worth keeping in the office if for no other reason than to help solve one of the most excruciatingly painful common problems in pediatrics: penile zipper entrapment.

Most textbooks advocate cutting the median bar of the zipper as the first-line solution. But that’s not the best method. A mineral oil drenching is the way to go, according to Dr. Steven M. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia.

"I’ve done this many times. You want to just pour mineral oil all over the patient’s genitalia and the zipper. Be generous – that’s the key. This is pretty cheap stuff. Then let the patient sit there for 20 or 30 minutes. Pack him in a room somewhere. When you come back, the foreskin will have simply slipped out of that zipper, although in some cases you may need a cotton swab to help it along a bit," he explained at the meeting sponsored by the American Academy of Pediatrics.

Cutting the median bar of a zipper isn’t as easy as it might sound. A metal zipper is a sturdy apparatus.

"We used to call housekeeping stat to the emergency department – ‘and bring wire cutters,’ " Dr. Selbst recalled. "But I can tell you that when you go to the patient holding wire cutters, you’ll see his eyes bulging out."

The injured boy often presents with swelling, maceration, and bleeding as a result of the foreskin being caught in the zipper teeth. It’s often helpful as an initial step to cut away the pants from the zipper area to remove the extra weight dragging downward.

Some texts suggest doing a penile block. Dr. Selbst advised against it.

"Most kids would rather die with that zipper attached to them than have you do a penile block. Most of us aren’t all that comfortable doing them anyway," the pediatrician commented.

After the penis has been freed, it’s important to warn the parents about the risk of infection and the need to keep the area clean. Prophylactic antibiotics are worth considering, although there aren’t good data to support efficacy, Dr. Selbst said.

He reported having no financial conflicts.

STEAMBOAT SPRINGS, COLO. – A big bottle of mineral oil is well worth keeping in the office if for no other reason than to help solve one of the most excruciatingly painful common problems in pediatrics: penile zipper entrapment.

Most textbooks advocate cutting the median bar of the zipper as the first-line solution. But that’s not the best method. A mineral oil drenching is the way to go, according to Dr. Steven M. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia.

"I’ve done this many times. You want to just pour mineral oil all over the patient’s genitalia and the zipper. Be generous – that’s the key. This is pretty cheap stuff. Then let the patient sit there for 20 or 30 minutes. Pack him in a room somewhere. When you come back, the foreskin will have simply slipped out of that zipper, although in some cases you may need a cotton swab to help it along a bit," he explained at the meeting sponsored by the American Academy of Pediatrics.

Cutting the median bar of a zipper isn’t as easy as it might sound. A metal zipper is a sturdy apparatus.

"We used to call housekeeping stat to the emergency department – ‘and bring wire cutters,’ " Dr. Selbst recalled. "But I can tell you that when you go to the patient holding wire cutters, you’ll see his eyes bulging out."

The injured boy often presents with swelling, maceration, and bleeding as a result of the foreskin being caught in the zipper teeth. It’s often helpful as an initial step to cut away the pants from the zipper area to remove the extra weight dragging downward.

Some texts suggest doing a penile block. Dr. Selbst advised against it.

"Most kids would rather die with that zipper attached to them than have you do a penile block. Most of us aren’t all that comfortable doing them anyway," the pediatrician commented.

After the penis has been freed, it’s important to warn the parents about the risk of infection and the need to keep the area clean. Prophylactic antibiotics are worth considering, although there aren’t good data to support efficacy, Dr. Selbst said.

He reported having no financial conflicts.

STEAMBOAT SPRINGS, COLO. – A big bottle of mineral oil is well worth keeping in the office if for no other reason than to help solve one of the most excruciatingly painful common problems in pediatrics: penile zipper entrapment.

Most textbooks advocate cutting the median bar of the zipper as the first-line solution. But that’s not the best method. A mineral oil drenching is the way to go, according to Dr. Steven M. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia.

"I’ve done this many times. You want to just pour mineral oil all over the patient’s genitalia and the zipper. Be generous – that’s the key. This is pretty cheap stuff. Then let the patient sit there for 20 or 30 minutes. Pack him in a room somewhere. When you come back, the foreskin will have simply slipped out of that zipper, although in some cases you may need a cotton swab to help it along a bit," he explained at the meeting sponsored by the American Academy of Pediatrics.

Cutting the median bar of a zipper isn’t as easy as it might sound. A metal zipper is a sturdy apparatus.

"We used to call housekeeping stat to the emergency department – ‘and bring wire cutters,’ " Dr. Selbst recalled. "But I can tell you that when you go to the patient holding wire cutters, you’ll see his eyes bulging out."

The injured boy often presents with swelling, maceration, and bleeding as a result of the foreskin being caught in the zipper teeth. It’s often helpful as an initial step to cut away the pants from the zipper area to remove the extra weight dragging downward.

Some texts suggest doing a penile block. Dr. Selbst advised against it.

"Most kids would rather die with that zipper attached to them than have you do a penile block. Most of us aren’t all that comfortable doing them anyway," the pediatrician commented.

After the penis has been freed, it’s important to warn the parents about the risk of infection and the need to keep the area clean. Prophylactic antibiotics are worth considering, although there aren’t good data to support efficacy, Dr. Selbst said.

He reported having no financial conflicts.

It has been 100 years since Sir William Osler outlined his concept of the relationship of the hospital to the university and to the education of physicians and nurses in an address to the Northumberland and Durham Medical Society in England. He stated that the hospital stands "primarily for the cure of the sick and the relief of suffering; secondly, for the study of the problems of disease; and thirdly, for the training of men and of women to serve the public as doctors and nurses. A majority of hospitals deal only with the first of these objects, and incidentally with the third" (Lancet 1911;177:211-3).

Of course, much has changed over the subsequent century, but much remains the same. The integration of the hospital into its role of a teaching institution was difficult even in the Oslerian age of the early 20th century. That relationship has become even more complex in contemporary medicine, in which the hospital has increasingly become the center of community and national health care.

Dr. Osler’s comments came to mind while I was reading a recent article about the development of concierge care in America’s most prestigious hospitals (New York Times, Jan. 22, 2012, p. 3A). A money manager recuperating from back pain is shown relaxing in a $1,600-a-day luxurious hospital room dressed in a spa-type bathrobe in New York City’s Mount Sinai Medical Center, where amenities include gourmet food service. "I have a primary care physician who acts as ringmaster for all my other doctors. And I see no people in training – only the best of the best," the patient said.

The hospital’s spokesperson indicated that the lack of house staff was a result of training limitations and not the preference of the rich patients. Mount Sinai has a long history of excellence in medical education, but the ambience now provided for its wealthy clientele protects them from any intrusion by medical students and house staff.

The American hospital has evolved over the last century from a place of last resort for the poor sick to a high-technology institution created for intensive medical and surgical therapy. Funded initially by community and religious benevolence, the hospital has now become big business and heavily dependent on private insurers, Medicare and Medicaid, and whatever evolves from the new health care laws.

Now divested of minor illnesses and routine surgical procedures that can be dealt with in the outpatient setting, it is filled with critically sick patients.

There has always been a tenuous balance between the goals of the community hospital and its educational responsibilities. The contemporary community hospital has enjoyed a profitable environment fed by private health insurance and sustained by federal dollars. Medicare, since its inception almost 50 years ago, has generously supported education through indirect funding for house staff education. This support has recently been significantly decreased, and realistic forecasts suggest that the previous profit margins will be a thing of the past as the federal and state budget puts constraints on both Medicare and Medicaid. Dr. Osler argued for the hospital financial supporters of teaching faculty and challenged local communities to dig deep into their pockets to support the education of medical students and house staff.

Now, with the increasing development of hospital-centric health care, the hospital has also become the focus of community health. The need to train more health professionals will put more pressure on hospitals to provide facilities for the whole dimension of caregivers, including medical students, house officers, nurses, and a variety of physician assistants. With increases in both the number of medical schools and the matriculating class sizes of current medical schools, more community hospitals will be called upon to provide clinical facilities to provide the training grounds for these new students. These changes will place financial pressures on the hospitals in order to meet that challenge. Even now, fast-track admissions and discharge practice, already a part of the patient experience in many hospitals and a source of their profit margin, adversely affects the quality of medical education.

To cushion the effects of the decrease in private and governmental support for medical education, hospitals will be have to seek other sources of income – like concierge services – in order to meet their social and educational responsibilities.

How they meet both of these challenges in the contemporary entrepreneurial world of health care will require a great degree of agility. But no matter what changes do occur, there will always be room for concierge care.

It has been 100 years since Sir William Osler outlined his concept of the relationship of the hospital to the university and to the education of physicians and nurses in an address to the Northumberland and Durham Medical Society in England. He stated that the hospital stands "primarily for the cure of the sick and the relief of suffering; secondly, for the study of the problems of disease; and thirdly, for the training of men and of women to serve the public as doctors and nurses. A majority of hospitals deal only with the first of these objects, and incidentally with the third" (Lancet 1911;177:211-3).

Of course, much has changed over the subsequent century, but much remains the same. The integration of the hospital into its role of a teaching institution was difficult even in the Oslerian age of the early 20th century. That relationship has become even more complex in contemporary medicine, in which the hospital has increasingly become the center of community and national health care.

Dr. Osler’s comments came to mind while I was reading a recent article about the development of concierge care in America’s most prestigious hospitals (New York Times, Jan. 22, 2012, p. 3A). A money manager recuperating from back pain is shown relaxing in a $1,600-a-day luxurious hospital room dressed in a spa-type bathrobe in New York City’s Mount Sinai Medical Center, where amenities include gourmet food service. "I have a primary care physician who acts as ringmaster for all my other doctors. And I see no people in training – only the best of the best," the patient said.

The hospital’s spokesperson indicated that the lack of house staff was a result of training limitations and not the preference of the rich patients. Mount Sinai has a long history of excellence in medical education, but the ambience now provided for its wealthy clientele protects them from any intrusion by medical students and house staff.

The American hospital has evolved over the last century from a place of last resort for the poor sick to a high-technology institution created for intensive medical and surgical therapy. Funded initially by community and religious benevolence, the hospital has now become big business and heavily dependent on private insurers, Medicare and Medicaid, and whatever evolves from the new health care laws.

Now divested of minor illnesses and routine surgical procedures that can be dealt with in the outpatient setting, it is filled with critically sick patients.

There has always been a tenuous balance between the goals of the community hospital and its educational responsibilities. The contemporary community hospital has enjoyed a profitable environment fed by private health insurance and sustained by federal dollars. Medicare, since its inception almost 50 years ago, has generously supported education through indirect funding for house staff education. This support has recently been significantly decreased, and realistic forecasts suggest that the previous profit margins will be a thing of the past as the federal and state budget puts constraints on both Medicare and Medicaid. Dr. Osler argued for the hospital financial supporters of teaching faculty and challenged local communities to dig deep into their pockets to support the education of medical students and house staff.

Now, with the increasing development of hospital-centric health care, the hospital has also become the focus of community health. The need to train more health professionals will put more pressure on hospitals to provide facilities for the whole dimension of caregivers, including medical students, house officers, nurses, and a variety of physician assistants. With increases in both the number of medical schools and the matriculating class sizes of current medical schools, more community hospitals will be called upon to provide clinical facilities to provide the training grounds for these new students. These changes will place financial pressures on the hospitals in order to meet that challenge. Even now, fast-track admissions and discharge practice, already a part of the patient experience in many hospitals and a source of their profit margin, adversely affects the quality of medical education.

To cushion the effects of the decrease in private and governmental support for medical education, hospitals will be have to seek other sources of income – like concierge services – in order to meet their social and educational responsibilities.

How they meet both of these challenges in the contemporary entrepreneurial world of health care will require a great degree of agility. But no matter what changes do occur, there will always be room for concierge care.

It has been 100 years since Sir William Osler outlined his concept of the relationship of the hospital to the university and to the education of physicians and nurses in an address to the Northumberland and Durham Medical Society in England. He stated that the hospital stands "primarily for the cure of the sick and the relief of suffering; secondly, for the study of the problems of disease; and thirdly, for the training of men and of women to serve the public as doctors and nurses. A majority of hospitals deal only with the first of these objects, and incidentally with the third" (Lancet 1911;177:211-3).

Of course, much has changed over the subsequent century, but much remains the same. The integration of the hospital into its role of a teaching institution was difficult even in the Oslerian age of the early 20th century. That relationship has become even more complex in contemporary medicine, in which the hospital has increasingly become the center of community and national health care.

Dr. Osler’s comments came to mind while I was reading a recent article about the development of concierge care in America’s most prestigious hospitals (New York Times, Jan. 22, 2012, p. 3A). A money manager recuperating from back pain is shown relaxing in a $1,600-a-day luxurious hospital room dressed in a spa-type bathrobe in New York City’s Mount Sinai Medical Center, where amenities include gourmet food service. "I have a primary care physician who acts as ringmaster for all my other doctors. And I see no people in training – only the best of the best," the patient said.

The hospital’s spokesperson indicated that the lack of house staff was a result of training limitations and not the preference of the rich patients. Mount Sinai has a long history of excellence in medical education, but the ambience now provided for its wealthy clientele protects them from any intrusion by medical students and house staff.

The American hospital has evolved over the last century from a place of last resort for the poor sick to a high-technology institution created for intensive medical and surgical therapy. Funded initially by community and religious benevolence, the hospital has now become big business and heavily dependent on private insurers, Medicare and Medicaid, and whatever evolves from the new health care laws.

Now divested of minor illnesses and routine surgical procedures that can be dealt with in the outpatient setting, it is filled with critically sick patients.

There has always been a tenuous balance between the goals of the community hospital and its educational responsibilities. The contemporary community hospital has enjoyed a profitable environment fed by private health insurance and sustained by federal dollars. Medicare, since its inception almost 50 years ago, has generously supported education through indirect funding for house staff education. This support has recently been significantly decreased, and realistic forecasts suggest that the previous profit margins will be a thing of the past as the federal and state budget puts constraints on both Medicare and Medicaid. Dr. Osler argued for the hospital financial supporters of teaching faculty and challenged local communities to dig deep into their pockets to support the education of medical students and house staff.

Now, with the increasing development of hospital-centric health care, the hospital has also become the focus of community health. The need to train more health professionals will put more pressure on hospitals to provide facilities for the whole dimension of caregivers, including medical students, house officers, nurses, and a variety of physician assistants. With increases in both the number of medical schools and the matriculating class sizes of current medical schools, more community hospitals will be called upon to provide clinical facilities to provide the training grounds for these new students. These changes will place financial pressures on the hospitals in order to meet that challenge. Even now, fast-track admissions and discharge practice, already a part of the patient experience in many hospitals and a source of their profit margin, adversely affects the quality of medical education.

To cushion the effects of the decrease in private and governmental support for medical education, hospitals will be have to seek other sources of income – like concierge services – in order to meet their social and educational responsibilities.

How they meet both of these challenges in the contemporary entrepreneurial world of health care will require a great degree of agility. But no matter what changes do occur, there will always be room for concierge care.

With a simple blood test, you can screen and potentially improve and extend the lives of children and adolescents with dyslipidemia.

This is one of the few areas of cardiovascular medicine where your initial diagnosis will make such a significant difference into adulthood. Dyslipidemia occurs more frequently than does structural congenital disease, heart rhythm disorders, heart failure, and most other conditions pediatric cardiologists manage.

In addition, you no longer have to wonder if you should evaluate your patients for dyslipidemia. In December 2011, the National Heart, Lung, and Blood Institute published guidelines on dyslipidemia in pediatric patients. Universal screening for dyslipidemia is now expected when children are 9-11 years old, even if they have no risk factors. The American Academy of Pediatrics endorsed this guidance.

Of course, there are situations where you might want to check earlier. If you identify any risk factor – relevant family history, obesity, or diabetes – you don’t have to wait until a child is 9 years old. You can screen these children when they are as young as 2 or 3 years.

The good news is that the guidelines do not require a fasting lipid profile ("Doctors Advised to Test Cholesterol in All Children Aged 9-11 Years," Pediatric News, Nov. 15, 2011). A nonfasting lipid profile reveals relevant information (except regarding HDL cholesterol), and is therefore an appropriate initial, universal screening tool. If you get a result out of the normal range or identify any new risk factors, a follow-up fasting lipid profile is warranted.

I’m glad to see that the guideline experts do not require a fasting assay. As many pediatricians can attest, overnight fasting can be very onerous for young patients and their families – especially if the well child visit is in the afternoon.

Once dyslipidemia is diagnosed, pediatricians can effectively manage most children with this condition. However, there also is a general consensus among these experts that the most severe childhood lipid abnormalities should be managed by lipid specialists. Hypercholesterolemia with a genetic etiology is worrisome, for example, especially if it’s heterozygous familial hypercholesterolemia.

Affected children will have significant elevations of LDL cholesterol – easily over 160 mg/dL and usually over 200 mg/dL. This condition affects about 1 in 500 people in the United States. Left undiagnosed and untreated, over their lifetimes about 50% of the men and 25% of the women will experience an important event – such as peripheral arterial disease or a heart attack – by the time they are 50.

If a person unknowingly grows to adulthood with heterozygous familial hypercholesterolemia, that person might experience a heart attack with no warning at age 30 (for men) or age 40 (for women).

This is all about prevention on the part of the pediatrician. Your early identification of patients with lipid abnormalities ties into "primordial prevention." In contrast to treating adults after they’ve developed cardiovascular disease, or performing "primary prevention" to prevent disease in a patient with known risk factors, pediatricians can prevent risk factors from developing in the first place. This means screening and counseling patients before they become obese, develop prehypertension, or present with prediabetes. Primordial prevention can delay or prevent a lot of these risk factors from becoming real issues.

If you identify and treat these patients with statins, you can restore normal longevity. Researchers have shown that these agents are just as safe and effective for children as they are for adults.

Dyslipidemia screening, diagnosis, and management are clinical areas where pediatricians and cardiologists can work together and make a real difference. I can’t think of anything better for pediatricians to do.

Dr. Hardin is director of the division of pediatric cardiology, and associate professor of pediatrics, at Loyola University Health System in Maywood, Ill. He had no relevant financial disclosures.

With a simple blood test, you can screen and potentially improve and extend the lives of children and adolescents with dyslipidemia.

This is one of the few areas of cardiovascular medicine where your initial diagnosis will make such a significant difference into adulthood. Dyslipidemia occurs more frequently than does structural congenital disease, heart rhythm disorders, heart failure, and most other conditions pediatric cardiologists manage.

In addition, you no longer have to wonder if you should evaluate your patients for dyslipidemia. In December 2011, the National Heart, Lung, and Blood Institute published guidelines on dyslipidemia in pediatric patients. Universal screening for dyslipidemia is now expected when children are 9-11 years old, even if they have no risk factors. The American Academy of Pediatrics endorsed this guidance.

Of course, there are situations where you might want to check earlier. If you identify any risk factor – relevant family history, obesity, or diabetes – you don’t have to wait until a child is 9 years old. You can screen these children when they are as young as 2 or 3 years.

The good news is that the guidelines do not require a fasting lipid profile ("Doctors Advised to Test Cholesterol in All Children Aged 9-11 Years," Pediatric News, Nov. 15, 2011). A nonfasting lipid profile reveals relevant information (except regarding HDL cholesterol), and is therefore an appropriate initial, universal screening tool. If you get a result out of the normal range or identify any new risk factors, a follow-up fasting lipid profile is warranted.

I’m glad to see that the guideline experts do not require a fasting assay. As many pediatricians can attest, overnight fasting can be very onerous for young patients and their families – especially if the well child visit is in the afternoon.

Once dyslipidemia is diagnosed, pediatricians can effectively manage most children with this condition. However, there also is a general consensus among these experts that the most severe childhood lipid abnormalities should be managed by lipid specialists. Hypercholesterolemia with a genetic etiology is worrisome, for example, especially if it’s heterozygous familial hypercholesterolemia.

Affected children will have significant elevations of LDL cholesterol – easily over 160 mg/dL and usually over 200 mg/dL. This condition affects about 1 in 500 people in the United States. Left undiagnosed and untreated, over their lifetimes about 50% of the men and 25% of the women will experience an important event – such as peripheral arterial disease or a heart attack – by the time they are 50.

If a person unknowingly grows to adulthood with heterozygous familial hypercholesterolemia, that person might experience a heart attack with no warning at age 30 (for men) or age 40 (for women).

This is all about prevention on the part of the pediatrician. Your early identification of patients with lipid abnormalities ties into "primordial prevention." In contrast to treating adults after they’ve developed cardiovascular disease, or performing "primary prevention" to prevent disease in a patient with known risk factors, pediatricians can prevent risk factors from developing in the first place. This means screening and counseling patients before they become obese, develop prehypertension, or present with prediabetes. Primordial prevention can delay or prevent a lot of these risk factors from becoming real issues.

If you identify and treat these patients with statins, you can restore normal longevity. Researchers have shown that these agents are just as safe and effective for children as they are for adults.

Dyslipidemia screening, diagnosis, and management are clinical areas where pediatricians and cardiologists can work together and make a real difference. I can’t think of anything better for pediatricians to do.

Dr. Hardin is director of the division of pediatric cardiology, and associate professor of pediatrics, at Loyola University Health System in Maywood, Ill. He had no relevant financial disclosures.

With a simple blood test, you can screen and potentially improve and extend the lives of children and adolescents with dyslipidemia.

This is one of the few areas of cardiovascular medicine where your initial diagnosis will make such a significant difference into adulthood. Dyslipidemia occurs more frequently than does structural congenital disease, heart rhythm disorders, heart failure, and most other conditions pediatric cardiologists manage.

In addition, you no longer have to wonder if you should evaluate your patients for dyslipidemia. In December 2011, the National Heart, Lung, and Blood Institute published guidelines on dyslipidemia in pediatric patients. Universal screening for dyslipidemia is now expected when children are 9-11 years old, even if they have no risk factors. The American Academy of Pediatrics endorsed this guidance.

Of course, there are situations where you might want to check earlier. If you identify any risk factor – relevant family history, obesity, or diabetes – you don’t have to wait until a child is 9 years old. You can screen these children when they are as young as 2 or 3 years.

The good news is that the guidelines do not require a fasting lipid profile ("Doctors Advised to Test Cholesterol in All Children Aged 9-11 Years," Pediatric News, Nov. 15, 2011). A nonfasting lipid profile reveals relevant information (except regarding HDL cholesterol), and is therefore an appropriate initial, universal screening tool. If you get a result out of the normal range or identify any new risk factors, a follow-up fasting lipid profile is warranted.

I’m glad to see that the guideline experts do not require a fasting assay. As many pediatricians can attest, overnight fasting can be very onerous for young patients and their families – especially if the well child visit is in the afternoon.

Once dyslipidemia is diagnosed, pediatricians can effectively manage most children with this condition. However, there also is a general consensus among these experts that the most severe childhood lipid abnormalities should be managed by lipid specialists. Hypercholesterolemia with a genetic etiology is worrisome, for example, especially if it’s heterozygous familial hypercholesterolemia.

Affected children will have significant elevations of LDL cholesterol – easily over 160 mg/dL and usually over 200 mg/dL. This condition affects about 1 in 500 people in the United States. Left undiagnosed and untreated, over their lifetimes about 50% of the men and 25% of the women will experience an important event – such as peripheral arterial disease or a heart attack – by the time they are 50.

If a person unknowingly grows to adulthood with heterozygous familial hypercholesterolemia, that person might experience a heart attack with no warning at age 30 (for men) or age 40 (for women).

This is all about prevention on the part of the pediatrician. Your early identification of patients with lipid abnormalities ties into "primordial prevention." In contrast to treating adults after they’ve developed cardiovascular disease, or performing "primary prevention" to prevent disease in a patient with known risk factors, pediatricians can prevent risk factors from developing in the first place. This means screening and counseling patients before they become obese, develop prehypertension, or present with prediabetes. Primordial prevention can delay or prevent a lot of these risk factors from becoming real issues.

If you identify and treat these patients with statins, you can restore normal longevity. Researchers have shown that these agents are just as safe and effective for children as they are for adults.

Dyslipidemia screening, diagnosis, and management are clinical areas where pediatricians and cardiologists can work together and make a real difference. I can’t think of anything better for pediatricians to do.

Dr. Hardin is director of the division of pediatric cardiology, and associate professor of pediatrics, at Loyola University Health System in Maywood, Ill. He had no relevant financial disclosures.

STEAMBOAT SPRINGS, COLO. – Replacing a knocked-out permanent tooth is a far-less-daunting proposition than it sounds, according to Dr. Steven M. Selbst.

"This is an easy procedure that I hope every pediatrician would be comfortable in doing," he said at the meeting sponsored by the American Academy of Pediatrics.

Time is critical. A tooth reinserted within 30 minutes after being knocked out has a 90% chance of survival. After that, the success rate drops off considerably.

A common scenario is for a parent to phone the pediatrician from the scene of the mishap, perhaps a playground, the backyard trampoline, or a baseball diamond. The parent should be instructed to immerse the tooth in milk, if immediately available, while transporting the youth to the physician’s office. If milk is not at hand, water is the next best. Failing that, the adult should put the tooth under his or her own tongue, according to Dr. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia, and an authority on emergency pediatrics.

It’s an excellent idea for every pediatrician’s office – and school nurses’ offices as well – to stock a container of the balanced salt solution known as Save-a-Tooth emergency tooth-preserving system filled with Hank’s balanced salt solution (HBSS). It’s inexpensive, available on the Internet, and extends the salvage time by several hours. As soon as the patient arrives at the office, the tooth can be placed in the HBSS while the treatment team assembles.

The tooth should always be handled by the crown, not the root. And even though the tooth may have been kicked around in the dirt, it shouldn’t be scrubbed clean; that would damage the fine root fibers that are essential to successful reattachment. Instead, the tooth can be gently irrigated with saline or tap water to clean it up.

The tooth socket is a gaping hole, often filled with a blood clot. This, too, should be gently irrigated. Wet gauze can be used to wipe away the clot.

There’s no need to anesthetize the tooth socket with a lidocaine injection.

"When the tooth got knocked out, most of the pain-carrying nerve fibers got knocked out along with it. It’s really not that painful to replace the tooth. The teenager is desperate for this procedure to be successful. He or she is going to do everything possible to help you along the way. They’ll tolerate a bit of pain or discomfort," Dr. Selbst explained.

The procedure itself is remarkably straightforward.

"You don’t need fancy equipment. You don’t need any anesthesia. You just need to have the courage to stick the tooth right back up in that big hole after you’ve cleaned it off," the pediatrician continued.

But first, make sure the tooth is correctly oriented: right side up, front facing forward.

Pretty much the only complication that can occur is if the nervous physician drops the tooth and the patient then swallows it. It’s game over at that point. For this reason, Dr. Selbst said he always has the patient sitting up to at least a 45-degree angle for the procedure rather than lying down.

The patient needs to go from the pediatrician to a dentist straight away so the tooth can be further stabilized. Have the youth bite down on a big wad of gauze to keep the loose tooth from moving around while in transit, he advised.

Dr. Selbst reported that he had no relevant financial disclosures.

STEAMBOAT SPRINGS, COLO. – Replacing a knocked-out permanent tooth is a far-less-daunting proposition than it sounds, according to Dr. Steven M. Selbst.

"This is an easy procedure that I hope every pediatrician would be comfortable in doing," he said at the meeting sponsored by the American Academy of Pediatrics.

Time is critical. A tooth reinserted within 30 minutes after being knocked out has a 90% chance of survival. After that, the success rate drops off considerably.

A common scenario is for a parent to phone the pediatrician from the scene of the mishap, perhaps a playground, the backyard trampoline, or a baseball diamond. The parent should be instructed to immerse the tooth in milk, if immediately available, while transporting the youth to the physician’s office. If milk is not at hand, water is the next best. Failing that, the adult should put the tooth under his or her own tongue, according to Dr. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia, and an authority on emergency pediatrics.

It’s an excellent idea for every pediatrician’s office – and school nurses’ offices as well – to stock a container of the balanced salt solution known as Save-a-Tooth emergency tooth-preserving system filled with Hank’s balanced salt solution (HBSS). It’s inexpensive, available on the Internet, and extends the salvage time by several hours. As soon as the patient arrives at the office, the tooth can be placed in the HBSS while the treatment team assembles.

The tooth should always be handled by the crown, not the root. And even though the tooth may have been kicked around in the dirt, it shouldn’t be scrubbed clean; that would damage the fine root fibers that are essential to successful reattachment. Instead, the tooth can be gently irrigated with saline or tap water to clean it up.

The tooth socket is a gaping hole, often filled with a blood clot. This, too, should be gently irrigated. Wet gauze can be used to wipe away the clot.

There’s no need to anesthetize the tooth socket with a lidocaine injection.

"When the tooth got knocked out, most of the pain-carrying nerve fibers got knocked out along with it. It’s really not that painful to replace the tooth. The teenager is desperate for this procedure to be successful. He or she is going to do everything possible to help you along the way. They’ll tolerate a bit of pain or discomfort," Dr. Selbst explained.

The procedure itself is remarkably straightforward.

"You don’t need fancy equipment. You don’t need any anesthesia. You just need to have the courage to stick the tooth right back up in that big hole after you’ve cleaned it off," the pediatrician continued.

But first, make sure the tooth is correctly oriented: right side up, front facing forward.

Pretty much the only complication that can occur is if the nervous physician drops the tooth and the patient then swallows it. It’s game over at that point. For this reason, Dr. Selbst said he always has the patient sitting up to at least a 45-degree angle for the procedure rather than lying down.

The patient needs to go from the pediatrician to a dentist straight away so the tooth can be further stabilized. Have the youth bite down on a big wad of gauze to keep the loose tooth from moving around while in transit, he advised.

Dr. Selbst reported that he had no relevant financial disclosures.

STEAMBOAT SPRINGS, COLO. – Replacing a knocked-out permanent tooth is a far-less-daunting proposition than it sounds, according to Dr. Steven M. Selbst.

"This is an easy procedure that I hope every pediatrician would be comfortable in doing," he said at the meeting sponsored by the American Academy of Pediatrics.

Time is critical. A tooth reinserted within 30 minutes after being knocked out has a 90% chance of survival. After that, the success rate drops off considerably.

A common scenario is for a parent to phone the pediatrician from the scene of the mishap, perhaps a playground, the backyard trampoline, or a baseball diamond. The parent should be instructed to immerse the tooth in milk, if immediately available, while transporting the youth to the physician’s office. If milk is not at hand, water is the next best. Failing that, the adult should put the tooth under his or her own tongue, according to Dr. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia, and an authority on emergency pediatrics.

It’s an excellent idea for every pediatrician’s office – and school nurses’ offices as well – to stock a container of the balanced salt solution known as Save-a-Tooth emergency tooth-preserving system filled with Hank’s balanced salt solution (HBSS). It’s inexpensive, available on the Internet, and extends the salvage time by several hours. As soon as the patient arrives at the office, the tooth can be placed in the HBSS while the treatment team assembles.

The tooth should always be handled by the crown, not the root. And even though the tooth may have been kicked around in the dirt, it shouldn’t be scrubbed clean; that would damage the fine root fibers that are essential to successful reattachment. Instead, the tooth can be gently irrigated with saline or tap water to clean it up.

The tooth socket is a gaping hole, often filled with a blood clot. This, too, should be gently irrigated. Wet gauze can be used to wipe away the clot.

There’s no need to anesthetize the tooth socket with a lidocaine injection.

"When the tooth got knocked out, most of the pain-carrying nerve fibers got knocked out along with it. It’s really not that painful to replace the tooth. The teenager is desperate for this procedure to be successful. He or she is going to do everything possible to help you along the way. They’ll tolerate a bit of pain or discomfort," Dr. Selbst explained.

The procedure itself is remarkably straightforward.

"You don’t need fancy equipment. You don’t need any anesthesia. You just need to have the courage to stick the tooth right back up in that big hole after you’ve cleaned it off," the pediatrician continued.

But first, make sure the tooth is correctly oriented: right side up, front facing forward.

Pretty much the only complication that can occur is if the nervous physician drops the tooth and the patient then swallows it. It’s game over at that point. For this reason, Dr. Selbst said he always has the patient sitting up to at least a 45-degree angle for the procedure rather than lying down.

The patient needs to go from the pediatrician to a dentist straight away so the tooth can be further stabilized. Have the youth bite down on a big wad of gauze to keep the loose tooth from moving around while in transit, he advised.

Dr. Selbst reported that he had no relevant financial disclosures.

At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.

Reporter Alicia Ault has this video report:

At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.

Reporter Alicia Ault has this video report:

At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.

Reporter Alicia Ault has this video report:

Hospitals are a place where people go to get healthy, but the same can't be said about all hospital cafeterias, according to a recent study by the Physicians Committee for Responsible Medicine (PCRM).

The study analyzed food served to patients, staff, and visitors at U.S. hospitals in all 50 states and the District of Columbia and found that some hospitals housed as many as five fast-food outlets and featured menus that were dominated by foods high in fat, cholesterol, sugar, and sodium. For hospitalists, many of whom spend 50, 70, and even 90 hours per week in the hospital, the lack of healthy eating options can be especially problematic.

"We relied on menus that were provided, and while we don't have the recipes in hand, we can tell a lot just by the fundamental ingredients," says Susan Levin, RD, PCRM's director of nutrition education and lead author of the study.

Levin says the presence of these kinds of foods in hospitals is "irresponsible," and suggests hospitals ban fast-food outlets and fill menus with low-fat, plant-based options as a way to "reverse and prevent disease."

Many hospital cafeterias around the country are doing just that. MetroWest Medical Center, just outside of Boston, has formed a "Go Green" committee that plans to group and label healthy versus nonhealthy drinks and snacks, and will reward patients and hospital staff for choosing water and other healthy options. Benioff Children's Hospital at the University of California at San Francisco (UCSF) Medical Center now offers nutritional information for entrees, and food-purchase receipts note calories and fat content.

PCRM hopes the study will encourage hospitals to lead the way in promoting healthful eating habits. "I hope that something is changing and people are thinking bigger picture and better care," Levin says.

Hospitals are a place where people go to get healthy, but the same can't be said about all hospital cafeterias, according to a recent study by the Physicians Committee for Responsible Medicine (PCRM).

The study analyzed food served to patients, staff, and visitors at U.S. hospitals in all 50 states and the District of Columbia and found that some hospitals housed as many as five fast-food outlets and featured menus that were dominated by foods high in fat, cholesterol, sugar, and sodium. For hospitalists, many of whom spend 50, 70, and even 90 hours per week in the hospital, the lack of healthy eating options can be especially problematic.

"We relied on menus that were provided, and while we don't have the recipes in hand, we can tell a lot just by the fundamental ingredients," says Susan Levin, RD, PCRM's director of nutrition education and lead author of the study.

Levin says the presence of these kinds of foods in hospitals is "irresponsible," and suggests hospitals ban fast-food outlets and fill menus with low-fat, plant-based options as a way to "reverse and prevent disease."

Many hospital cafeterias around the country are doing just that. MetroWest Medical Center, just outside of Boston, has formed a "Go Green" committee that plans to group and label healthy versus nonhealthy drinks and snacks, and will reward patients and hospital staff for choosing water and other healthy options. Benioff Children's Hospital at the University of California at San Francisco (UCSF) Medical Center now offers nutritional information for entrees, and food-purchase receipts note calories and fat content.

PCRM hopes the study will encourage hospitals to lead the way in promoting healthful eating habits. "I hope that something is changing and people are thinking bigger picture and better care," Levin says.

Hospitals are a place where people go to get healthy, but the same can't be said about all hospital cafeterias, according to a recent study by the Physicians Committee for Responsible Medicine (PCRM).

The study analyzed food served to patients, staff, and visitors at U.S. hospitals in all 50 states and the District of Columbia and found that some hospitals housed as many as five fast-food outlets and featured menus that were dominated by foods high in fat, cholesterol, sugar, and sodium. For hospitalists, many of whom spend 50, 70, and even 90 hours per week in the hospital, the lack of healthy eating options can be especially problematic.

"We relied on menus that were provided, and while we don't have the recipes in hand, we can tell a lot just by the fundamental ingredients," says Susan Levin, RD, PCRM's director of nutrition education and lead author of the study.

Levin says the presence of these kinds of foods in hospitals is "irresponsible," and suggests hospitals ban fast-food outlets and fill menus with low-fat, plant-based options as a way to "reverse and prevent disease."

Many hospital cafeterias around the country are doing just that. MetroWest Medical Center, just outside of Boston, has formed a "Go Green" committee that plans to group and label healthy versus nonhealthy drinks and snacks, and will reward patients and hospital staff for choosing water and other healthy options. Benioff Children's Hospital at the University of California at San Francisco (UCSF) Medical Center now offers nutritional information for entrees, and food-purchase receipts note calories and fat content.

PCRM hopes the study will encourage hospitals to lead the way in promoting healthful eating habits. "I hope that something is changing and people are thinking bigger picture and better care," Levin says.

An emerging category of hospital quality initiatives, comparable to preventing medical errors and improving quality and patient safety, could be labeled “waste management” or “waste reduction.” "Waste" in this sense refers not to biohazardous substances in need of disposal, but to the overuse of medical resources—such as lab tests and pharmaceuticals—when they are not helpful to a patient's medical management.

This will be a growing focus for hospitalists, says Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California at San Francisco (UCSF) Medical Center, and author of the HM-focused blog, Wachter's World.

"If patients are getting CAT scans they don't really need or an extra day of telemetry because we don't have criteria for who should be on telemetry, that's wasteful, it's costly, and it could be dangerous,” Dr. Wachter explained at the UCSF Management of the Hospitalized Patient meeting last October. "The data are clear that 30% of what we do in American medicine is of no value to patients—and some substantial portion of that is harmful as well. I think we as hospitalists should be identifying what these wasteful things are—and making the hard decisions to stop them."

In an academic setting such as UCSF, many of the hospitalists lead quality, safety, and "waste reduction" projects, which often use similar tools and methods but have a different focus. Dr. Wachter's colleague Niraj Sehgal, MD, MPH, the department of medicine's associate chair for quality improvement (QI) and patient safety, says that process-improvement tools such as Six Sigma and Lean methodologies can put unnecessary variation and waste under the microscope. But at UCSF, these efforts start with just looking at the data, then sharing the data with trainees and faculty.

"Clearly, attention is growing to this issue," Dr. Sehgal says. "We often talk about generating value in healthcare where value equals quality divided by cost, but we need to include the concept of appropriateness in that equation as well."

A radiology utilization awareness project at UCSF is looking at whether cost and radiation exposure information might influence the ordering of five common radiologic tests that together generate annual charges of nearly $10 million at UCSF's Moffitt-Long Medical Service. The project uses a number of educational strategies to encourage providers to think about whether the tests will change their clinical management.

"The preliminary data suggest that simply providing the cost and utilization data decreased utilization for three of the five tests evaluated," Dr. Sehgal says.

Physicians didn't necessarily ignore inefficiency and overuse in the past, he adds, but healthcare reform offers new opportunities to leverage greater cost consciousness in medical education and practice. "We're not having to convince our trainees and faculty that cost is important," he says. "They just don't always see the costs involved."

An emerging category of hospital quality initiatives, comparable to preventing medical errors and improving quality and patient safety, could be labeled “waste management” or “waste reduction.” "Waste" in this sense refers not to biohazardous substances in need of disposal, but to the overuse of medical resources—such as lab tests and pharmaceuticals—when they are not helpful to a patient's medical management.

This will be a growing focus for hospitalists, says Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California at San Francisco (UCSF) Medical Center, and author of the HM-focused blog, Wachter's World.

"If patients are getting CAT scans they don't really need or an extra day of telemetry because we don't have criteria for who should be on telemetry, that's wasteful, it's costly, and it could be dangerous,” Dr. Wachter explained at the UCSF Management of the Hospitalized Patient meeting last October. "The data are clear that 30% of what we do in American medicine is of no value to patients—and some substantial portion of that is harmful as well. I think we as hospitalists should be identifying what these wasteful things are—and making the hard decisions to stop them."

In an academic setting such as UCSF, many of the hospitalists lead quality, safety, and "waste reduction" projects, which often use similar tools and methods but have a different focus. Dr. Wachter's colleague Niraj Sehgal, MD, MPH, the department of medicine's associate chair for quality improvement (QI) and patient safety, says that process-improvement tools such as Six Sigma and Lean methodologies can put unnecessary variation and waste under the microscope. But at UCSF, these efforts start with just looking at the data, then sharing the data with trainees and faculty.

"Clearly, attention is growing to this issue," Dr. Sehgal says. "We often talk about generating value in healthcare where value equals quality divided by cost, but we need to include the concept of appropriateness in that equation as well."

A radiology utilization awareness project at UCSF is looking at whether cost and radiation exposure information might influence the ordering of five common radiologic tests that together generate annual charges of nearly $10 million at UCSF's Moffitt-Long Medical Service. The project uses a number of educational strategies to encourage providers to think about whether the tests will change their clinical management.

"The preliminary data suggest that simply providing the cost and utilization data decreased utilization for three of the five tests evaluated," Dr. Sehgal says.

Physicians didn't necessarily ignore inefficiency and overuse in the past, he adds, but healthcare reform offers new opportunities to leverage greater cost consciousness in medical education and practice. "We're not having to convince our trainees and faculty that cost is important," he says. "They just don't always see the costs involved."

An emerging category of hospital quality initiatives, comparable to preventing medical errors and improving quality and patient safety, could be labeled “waste management” or “waste reduction.” "Waste" in this sense refers not to biohazardous substances in need of disposal, but to the overuse of medical resources—such as lab tests and pharmaceuticals—when they are not helpful to a patient's medical management.

This will be a growing focus for hospitalists, says Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California at San Francisco (UCSF) Medical Center, and author of the HM-focused blog, Wachter's World.

"If patients are getting CAT scans they don't really need or an extra day of telemetry because we don't have criteria for who should be on telemetry, that's wasteful, it's costly, and it could be dangerous,” Dr. Wachter explained at the UCSF Management of the Hospitalized Patient meeting last October. "The data are clear that 30% of what we do in American medicine is of no value to patients—and some substantial portion of that is harmful as well. I think we as hospitalists should be identifying what these wasteful things are—and making the hard decisions to stop them."

In an academic setting such as UCSF, many of the hospitalists lead quality, safety, and "waste reduction" projects, which often use similar tools and methods but have a different focus. Dr. Wachter's colleague Niraj Sehgal, MD, MPH, the department of medicine's associate chair for quality improvement (QI) and patient safety, says that process-improvement tools such as Six Sigma and Lean methodologies can put unnecessary variation and waste under the microscope. But at UCSF, these efforts start with just looking at the data, then sharing the data with trainees and faculty.

"Clearly, attention is growing to this issue," Dr. Sehgal says. "We often talk about generating value in healthcare where value equals quality divided by cost, but we need to include the concept of appropriateness in that equation as well."

A radiology utilization awareness project at UCSF is looking at whether cost and radiation exposure information might influence the ordering of five common radiologic tests that together generate annual charges of nearly $10 million at UCSF's Moffitt-Long Medical Service. The project uses a number of educational strategies to encourage providers to think about whether the tests will change their clinical management.

"The preliminary data suggest that simply providing the cost and utilization data decreased utilization for three of the five tests evaluated," Dr. Sehgal says.

Physicians didn't necessarily ignore inefficiency and overuse in the past, he adds, but healthcare reform offers new opportunities to leverage greater cost consciousness in medical education and practice. "We're not having to convince our trainees and faculty that cost is important," he says. "They just don't always see the costs involved."

MIAMI BEACH – Patients with head and neck cancers who develop alcohol withdrawal syndrome perioperatively experience significantly more complications after undergoing surgery, a large database analysis indicates.

The presence of withdrawal symptoms was associated with a 25% incidence of postoperative complications, compared with 14% among patients who abused alcohol and 7% among those without alcohol abuse, Dr. Dane J. Genther said at the Triological Society’s Combined Sections Meeting. The risk for wound complications was nearly double in this population (odds ratio, 1.9).

Dr. Genther, a resident in otolaryngologyhead and neck surgery at Johns Hopkins Hospital in Baltimore, and his associates used ICD-9 codes in the Nationwide Inpatient Sample discharge database to identify more than 92,000 patients who underwent an ablative procedure for head and neck cancer in 2003-2008. The retrospective, cross-sectional study included patients with malignant oral cavity, laryngeal, hypopharyngeal, and oropharyngeal neoplasms.

In a multivariate analysis, alcohol withdrawal syndrome was significantly more likely for patients undergoing a major procedure (OR, 2.0) and was significantly associated with Medicare payer status and a need for additional health care following discharge, Dr. Genther said.

The researchers found no significant association between alcohol withdrawal syndrome and increased risk for postoperative infections or in-hospital mortality, but there was a significant increase in hospital stay and related costs associated with the syndrome.

Having a major procedure and experiencing alcohol withdrawal contributed approximately $15,000 per admission in 2011 U.S. dollars, Dr. Genther said.

The findings point to a need for alternatives to current alcohol withdrawal prevention therapies, Dr. Genther said. "Despite prophylaxis, which is our current treatment to attempt to stem the onset of alcohol withdrawal syndrome, complications do occur and they are no less severe or frequent than in the absence of prophylaxis."

Abstinence from alcohol for at least 4 weeks is another strategy proposed to minimize risk of alcohol withdrawal syndrome for any at-risk surgical patient, said Dr. Genther. However, he added, "for many cancer patients, especially those with more advanced disease, waiting a prolonged period of time to possibly gain that benefit from abstinence is not necessarily a viable option."

Another aim of the study was to assess factors contributing to alcohol abuse. Patients aged 40-64 years had the highest proportion of alcohol abuse, and this age range was a significant factor (OR, 2.37). Those who abused alcohol were more often male and more often underwent major procedures, Dr. Genther said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. In addition, alcohol abuse was significantly associated with pneumonia and need for additional postdischarge health care.

Dr. Genther received a G. Slaughter Fitz-Hugh Resident Research Award for this study from the Triological Society. He reported having no financial disclosures.

MIAMI BEACH – Patients with head and neck cancers who develop alcohol withdrawal syndrome perioperatively experience significantly more complications after undergoing surgery, a large database analysis indicates.

The presence of withdrawal symptoms was associated with a 25% incidence of postoperative complications, compared with 14% among patients who abused alcohol and 7% among those without alcohol abuse, Dr. Dane J. Genther said at the Triological Society’s Combined Sections Meeting. The risk for wound complications was nearly double in this population (odds ratio, 1.9).

Dr. Genther, a resident in otolaryngologyhead and neck surgery at Johns Hopkins Hospital in Baltimore, and his associates used ICD-9 codes in the Nationwide Inpatient Sample discharge database to identify more than 92,000 patients who underwent an ablative procedure for head and neck cancer in 2003-2008. The retrospective, cross-sectional study included patients with malignant oral cavity, laryngeal, hypopharyngeal, and oropharyngeal neoplasms.

In a multivariate analysis, alcohol withdrawal syndrome was significantly more likely for patients undergoing a major procedure (OR, 2.0) and was significantly associated with Medicare payer status and a need for additional health care following discharge, Dr. Genther said.

The researchers found no significant association between alcohol withdrawal syndrome and increased risk for postoperative infections or in-hospital mortality, but there was a significant increase in hospital stay and related costs associated with the syndrome.

Having a major procedure and experiencing alcohol withdrawal contributed approximately $15,000 per admission in 2011 U.S. dollars, Dr. Genther said.

The findings point to a need for alternatives to current alcohol withdrawal prevention therapies, Dr. Genther said. "Despite prophylaxis, which is our current treatment to attempt to stem the onset of alcohol withdrawal syndrome, complications do occur and they are no less severe or frequent than in the absence of prophylaxis."

Abstinence from alcohol for at least 4 weeks is another strategy proposed to minimize risk of alcohol withdrawal syndrome for any at-risk surgical patient, said Dr. Genther. However, he added, "for many cancer patients, especially those with more advanced disease, waiting a prolonged period of time to possibly gain that benefit from abstinence is not necessarily a viable option."

Another aim of the study was to assess factors contributing to alcohol abuse. Patients aged 40-64 years had the highest proportion of alcohol abuse, and this age range was a significant factor (OR, 2.37). Those who abused alcohol were more often male and more often underwent major procedures, Dr. Genther said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. In addition, alcohol abuse was significantly associated with pneumonia and need for additional postdischarge health care.

Dr. Genther received a G. Slaughter Fitz-Hugh Resident Research Award for this study from the Triological Society. He reported having no financial disclosures.

MIAMI BEACH – Patients with head and neck cancers who develop alcohol withdrawal syndrome perioperatively experience significantly more complications after undergoing surgery, a large database analysis indicates.

The presence of withdrawal symptoms was associated with a 25% incidence of postoperative complications, compared with 14% among patients who abused alcohol and 7% among those without alcohol abuse, Dr. Dane J. Genther said at the Triological Society’s Combined Sections Meeting. The risk for wound complications was nearly double in this population (odds ratio, 1.9).

Dr. Genther, a resident in otolaryngologyhead and neck surgery at Johns Hopkins Hospital in Baltimore, and his associates used ICD-9 codes in the Nationwide Inpatient Sample discharge database to identify more than 92,000 patients who underwent an ablative procedure for head and neck cancer in 2003-2008. The retrospective, cross-sectional study included patients with malignant oral cavity, laryngeal, hypopharyngeal, and oropharyngeal neoplasms.

In a multivariate analysis, alcohol withdrawal syndrome was significantly more likely for patients undergoing a major procedure (OR, 2.0) and was significantly associated with Medicare payer status and a need for additional health care following discharge, Dr. Genther said.

The researchers found no significant association between alcohol withdrawal syndrome and increased risk for postoperative infections or in-hospital mortality, but there was a significant increase in hospital stay and related costs associated with the syndrome.

Having a major procedure and experiencing alcohol withdrawal contributed approximately $15,000 per admission in 2011 U.S. dollars, Dr. Genther said.

The findings point to a need for alternatives to current alcohol withdrawal prevention therapies, Dr. Genther said. "Despite prophylaxis, which is our current treatment to attempt to stem the onset of alcohol withdrawal syndrome, complications do occur and they are no less severe or frequent than in the absence of prophylaxis."

Abstinence from alcohol for at least 4 weeks is another strategy proposed to minimize risk of alcohol withdrawal syndrome for any at-risk surgical patient, said Dr. Genther. However, he added, "for many cancer patients, especially those with more advanced disease, waiting a prolonged period of time to possibly gain that benefit from abstinence is not necessarily a viable option."

Another aim of the study was to assess factors contributing to alcohol abuse. Patients aged 40-64 years had the highest proportion of alcohol abuse, and this age range was a significant factor (OR, 2.37). Those who abused alcohol were more often male and more often underwent major procedures, Dr. Genther said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. In addition, alcohol abuse was significantly associated with pneumonia and need for additional postdischarge health care.

Dr. Genther received a G. Slaughter Fitz-Hugh Resident Research Award for this study from the Triological Society. He reported having no financial disclosures.