We emergency physicians are generally a confident bunch. But in the time it takes to slip on a peel and hit the pavement (a bananosecond), some of us ratchet up adrenaline output when we pick up a chart and notice a history like 22 yo F, minor MVC, c/o headache and back pain, 32 weeks pregnant.

From whence comes this anxiety? A bit may stem from reading about those seven-figure lawsuit verdicts for pregnancy-related malpractice cases. However, tied to this are those questions and comments I often hear from residents seeking assurance, even when they know the answers.

Can I get this x-ray?

Is it OK to give her morphine IV? Should I start with 1 mg? (Sure, if it’s in the right acupuncture point.)

Wow, I’m so used to not treating asymptomatic elevated BP that I almost forgot to address it for this pregnant patient.

Getting answers from specialists can often be frustrating. The OB doc may be uncomfortable with the non-OB aspects of the case, while the other consulting specialists may be uncomfortable applying their expertise in the context of pregnancy.

I recall asking a surgeon to look at a third-trimester patient with likely appendicitis and an equivocal ultrasound. His plan related to me was, "We’ll sit on it overnight." After making some remark about his own application of procto-tocin, I suggested an MRI. He was a bit leery, but with some education and pressure on our radiologist to do our hospital’s first MRI to rule out appendicitis (accomplished without procedural sedation on that radiologist), we identified an acute appy.

As with many aspects of EM, it may be up to the EP to coordinate optimal care in these situations. In 1981, Dr. Arnold Greensher and I developed a system called Prenatal Care – A Systems Approach to help OBs and primary care physicians integrate prenatal care within a comprehensive risk management system. It includes frequently updated information on managing nonobstetric illness and injury in this population. The system’s development was coordinated with a panel of well-regarded academic specialists, including a group of perinatologists.

The track record for the system has been quite surprising to us, as well as to the medical malpractice insurers who purchased the system for their docs: There were more than 1.5 million deliveries during this time period with only 8 malpractice claims. The expected number of claims would be 400-700. For a large number of users, premium rates went down dramatically during a time when national rates were going in the opposite direction.

Over the past year, I’ve contributed two well-received articles for the Focus On series in ACEP News: Trauma in the Obstetric Patient in July 2010 and Perinatal Disaster Management in September 2011 (both can be found at www.acep.org/focuson). I was honored to be invited by the publication’s editorial panel to provide a quarterly column that focuses on unique aspects of emergency care of the pregnant patient. The goal of this column will be to provide practical recommendations for the EP on common presenting problems in this population. I will often have coauthors, including specialists in that topic, as well as perinatologist input. One of our residents will be an integral part of this group. Our column is not intended to be a standard of care, but rather a sound, easy-to-use package of recommendations that would be considered one avenue for providing optimal care.

Each article will have a clinical tool – a summary that can stand alone for easy reference. In fact, our Trauma Table is posted in a number of EDs that I have visited. As ACEP News technology progresses, we hope to have these as a library with the tables hyperlinked to the specific didactic parts of the articles.

In this issue, we debut our first article, Stroke in Pregnancy (pp. XX-XX). This will provide a nice supplement to any stroke protocols at your hospital. Later in 2012, we plan to have one on sepsis and another on cardiac emergencies, including acute coronary syndromes.

I look forward to sharing this column with you.

Dr. Roemer is an Associate Professor in the Department of Emergency Medicine, Oklahoma University School of Community Medicine, Tulsa.

We emergency physicians are generally a confident bunch. But in the time it takes to slip on a peel and hit the pavement (a bananosecond), some of us ratchet up adrenaline output when we pick up a chart and notice a history like 22 yo F, minor MVC, c/o headache and back pain, 32 weeks pregnant.

From whence comes this anxiety? A bit may stem from reading about those seven-figure lawsuit verdicts for pregnancy-related malpractice cases. However, tied to this are those questions and comments I often hear from residents seeking assurance, even when they know the answers.

Can I get this x-ray?

Is it OK to give her morphine IV? Should I start with 1 mg? (Sure, if it’s in the right acupuncture point.)

Wow, I’m so used to not treating asymptomatic elevated BP that I almost forgot to address it for this pregnant patient.

Getting answers from specialists can often be frustrating. The OB doc may be uncomfortable with the non-OB aspects of the case, while the other consulting specialists may be uncomfortable applying their expertise in the context of pregnancy.

I recall asking a surgeon to look at a third-trimester patient with likely appendicitis and an equivocal ultrasound. His plan related to me was, "We’ll sit on it overnight." After making some remark about his own application of procto-tocin, I suggested an MRI. He was a bit leery, but with some education and pressure on our radiologist to do our hospital’s first MRI to rule out appendicitis (accomplished without procedural sedation on that radiologist), we identified an acute appy.

As with many aspects of EM, it may be up to the EP to coordinate optimal care in these situations. In 1981, Dr. Arnold Greensher and I developed a system called Prenatal Care – A Systems Approach to help OBs and primary care physicians integrate prenatal care within a comprehensive risk management system. It includes frequently updated information on managing nonobstetric illness and injury in this population. The system’s development was coordinated with a panel of well-regarded academic specialists, including a group of perinatologists.

The track record for the system has been quite surprising to us, as well as to the medical malpractice insurers who purchased the system for their docs: There were more than 1.5 million deliveries during this time period with only 8 malpractice claims. The expected number of claims would be 400-700. For a large number of users, premium rates went down dramatically during a time when national rates were going in the opposite direction.

Over the past year, I’ve contributed two well-received articles for the Focus On series in ACEP News: Trauma in the Obstetric Patient in July 2010 and Perinatal Disaster Management in September 2011 (both can be found at www.acep.org/focuson). I was honored to be invited by the publication’s editorial panel to provide a quarterly column that focuses on unique aspects of emergency care of the pregnant patient. The goal of this column will be to provide practical recommendations for the EP on common presenting problems in this population. I will often have coauthors, including specialists in that topic, as well as perinatologist input. One of our residents will be an integral part of this group. Our column is not intended to be a standard of care, but rather a sound, easy-to-use package of recommendations that would be considered one avenue for providing optimal care.

Each article will have a clinical tool – a summary that can stand alone for easy reference. In fact, our Trauma Table is posted in a number of EDs that I have visited. As ACEP News technology progresses, we hope to have these as a library with the tables hyperlinked to the specific didactic parts of the articles.

In this issue, we debut our first article, Stroke in Pregnancy (pp. XX-XX). This will provide a nice supplement to any stroke protocols at your hospital. Later in 2012, we plan to have one on sepsis and another on cardiac emergencies, including acute coronary syndromes.

I look forward to sharing this column with you.

Dr. Roemer is an Associate Professor in the Department of Emergency Medicine, Oklahoma University School of Community Medicine, Tulsa.

We emergency physicians are generally a confident bunch. But in the time it takes to slip on a peel and hit the pavement (a bananosecond), some of us ratchet up adrenaline output when we pick up a chart and notice a history like 22 yo F, minor MVC, c/o headache and back pain, 32 weeks pregnant.

From whence comes this anxiety? A bit may stem from reading about those seven-figure lawsuit verdicts for pregnancy-related malpractice cases. However, tied to this are those questions and comments I often hear from residents seeking assurance, even when they know the answers.

Can I get this x-ray?

Is it OK to give her morphine IV? Should I start with 1 mg? (Sure, if it’s in the right acupuncture point.)

Wow, I’m so used to not treating asymptomatic elevated BP that I almost forgot to address it for this pregnant patient.

Getting answers from specialists can often be frustrating. The OB doc may be uncomfortable with the non-OB aspects of the case, while the other consulting specialists may be uncomfortable applying their expertise in the context of pregnancy.

I recall asking a surgeon to look at a third-trimester patient with likely appendicitis and an equivocal ultrasound. His plan related to me was, "We’ll sit on it overnight." After making some remark about his own application of procto-tocin, I suggested an MRI. He was a bit leery, but with some education and pressure on our radiologist to do our hospital’s first MRI to rule out appendicitis (accomplished without procedural sedation on that radiologist), we identified an acute appy.

As with many aspects of EM, it may be up to the EP to coordinate optimal care in these situations. In 1981, Dr. Arnold Greensher and I developed a system called Prenatal Care – A Systems Approach to help OBs and primary care physicians integrate prenatal care within a comprehensive risk management system. It includes frequently updated information on managing nonobstetric illness and injury in this population. The system’s development was coordinated with a panel of well-regarded academic specialists, including a group of perinatologists.

The track record for the system has been quite surprising to us, as well as to the medical malpractice insurers who purchased the system for their docs: There were more than 1.5 million deliveries during this time period with only 8 malpractice claims. The expected number of claims would be 400-700. For a large number of users, premium rates went down dramatically during a time when national rates were going in the opposite direction.

Over the past year, I’ve contributed two well-received articles for the Focus On series in ACEP News: Trauma in the Obstetric Patient in July 2010 and Perinatal Disaster Management in September 2011 (both can be found at www.acep.org/focuson). I was honored to be invited by the publication’s editorial panel to provide a quarterly column that focuses on unique aspects of emergency care of the pregnant patient. The goal of this column will be to provide practical recommendations for the EP on common presenting problems in this population. I will often have coauthors, including specialists in that topic, as well as perinatologist input. One of our residents will be an integral part of this group. Our column is not intended to be a standard of care, but rather a sound, easy-to-use package of recommendations that would be considered one avenue for providing optimal care.

Each article will have a clinical tool – a summary that can stand alone for easy reference. In fact, our Trauma Table is posted in a number of EDs that I have visited. As ACEP News technology progresses, we hope to have these as a library with the tables hyperlinked to the specific didactic parts of the articles.

In this issue, we debut our first article, Stroke in Pregnancy (pp. XX-XX). This will provide a nice supplement to any stroke protocols at your hospital. Later in 2012, we plan to have one on sepsis and another on cardiac emergencies, including acute coronary syndromes.

I look forward to sharing this column with you.

Dr. Roemer is an Associate Professor in the Department of Emergency Medicine, Oklahoma University School of Community Medicine, Tulsa.

The European Medicines Agency (EMA) has recommended that pixantrone dimaleate (Pixuvri) be granted conditional approval to treat non-Hodgkin B-cell lymphoma.

The approval is for pixantrone as single-agent therapy for patients with relapsed or refractory lymphoma.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended conditional approval of pixantrone because the data are not yet comprehensive. The CHMP has said more information is needed on the benefits of pixantrone in patients who received prior rituximab.

At the same time, the CHMP concluded that pixantrone satisfies an unmet medical need because there are no approved and standard treatments for this stage of the disease. Therefore, the benefits of making this medicine available on the market immediately outweigh the risks inherent in the fact that additional data are required.

The conditional approval of pixantrone will be renewed on a yearly basis until the obligation to provide additional data on rituximab-pretreated patients has been fulfilled. The applicant, CTI Life Sciences Ltd., has said it plans to provide the data by mid-2015.

The main study of pixantrone, the phase 3 EXTEND PIX301 trial, compared the drug to other chemotherapeutic agents in patients with relapsed or refractory non-Hodgkin lymphoma. The rate of response was 20% in the pixantrone arm and 6% in the comparator arm. 

In addition, patients receiving pixantrone had longer progression-free survival than patients in the comparator group, with a median of 10.2 months and 7.6 months, respectively.

However, the CHMP noted that the benefit of pixantrone appeared to be lower in patients who had received prior rituximab. And a benefit was not established in patients who had not responded to their last treatment and received pixantrone as the fifth or later round of chemotherapy.

The most common side effects observed with pixantrone were neutropenia, leukopenia, anemia, thrombocytopenia, asthenia, pyrexia, cough, decreased ejection fraction, and nausea. The most common grade 3 and 4 adverse events were hematologic.

The CHMP’s recommendation for conditional approval has been sent to the European Commission for the adoption of a European Union-wide decision. For more information on pixantrone’s approval, visit the EMA website.

The European Medicines Agency (EMA) has recommended that pixantrone dimaleate (Pixuvri) be granted conditional approval to treat non-Hodgkin B-cell lymphoma.

The approval is for pixantrone as single-agent therapy for patients with relapsed or refractory lymphoma.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended conditional approval of pixantrone because the data are not yet comprehensive. The CHMP has said more information is needed on the benefits of pixantrone in patients who received prior rituximab.

At the same time, the CHMP concluded that pixantrone satisfies an unmet medical need because there are no approved and standard treatments for this stage of the disease. Therefore, the benefits of making this medicine available on the market immediately outweigh the risks inherent in the fact that additional data are required.

The conditional approval of pixantrone will be renewed on a yearly basis until the obligation to provide additional data on rituximab-pretreated patients has been fulfilled. The applicant, CTI Life Sciences Ltd., has said it plans to provide the data by mid-2015.

The main study of pixantrone, the phase 3 EXTEND PIX301 trial, compared the drug to other chemotherapeutic agents in patients with relapsed or refractory non-Hodgkin lymphoma. The rate of response was 20% in the pixantrone arm and 6% in the comparator arm. 

In addition, patients receiving pixantrone had longer progression-free survival than patients in the comparator group, with a median of 10.2 months and 7.6 months, respectively.

However, the CHMP noted that the benefit of pixantrone appeared to be lower in patients who had received prior rituximab. And a benefit was not established in patients who had not responded to their last treatment and received pixantrone as the fifth or later round of chemotherapy.

The most common side effects observed with pixantrone were neutropenia, leukopenia, anemia, thrombocytopenia, asthenia, pyrexia, cough, decreased ejection fraction, and nausea. The most common grade 3 and 4 adverse events were hematologic.

The CHMP’s recommendation for conditional approval has been sent to the European Commission for the adoption of a European Union-wide decision. For more information on pixantrone’s approval, visit the EMA website.

The European Medicines Agency (EMA) has recommended that pixantrone dimaleate (Pixuvri) be granted conditional approval to treat non-Hodgkin B-cell lymphoma.

The approval is for pixantrone as single-agent therapy for patients with relapsed or refractory lymphoma.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended conditional approval of pixantrone because the data are not yet comprehensive. The CHMP has said more information is needed on the benefits of pixantrone in patients who received prior rituximab.

At the same time, the CHMP concluded that pixantrone satisfies an unmet medical need because there are no approved and standard treatments for this stage of the disease. Therefore, the benefits of making this medicine available on the market immediately outweigh the risks inherent in the fact that additional data are required.

The conditional approval of pixantrone will be renewed on a yearly basis until the obligation to provide additional data on rituximab-pretreated patients has been fulfilled. The applicant, CTI Life Sciences Ltd., has said it plans to provide the data by mid-2015.

The main study of pixantrone, the phase 3 EXTEND PIX301 trial, compared the drug to other chemotherapeutic agents in patients with relapsed or refractory non-Hodgkin lymphoma. The rate of response was 20% in the pixantrone arm and 6% in the comparator arm. 

In addition, patients receiving pixantrone had longer progression-free survival than patients in the comparator group, with a median of 10.2 months and 7.6 months, respectively.

However, the CHMP noted that the benefit of pixantrone appeared to be lower in patients who had received prior rituximab. And a benefit was not established in patients who had not responded to their last treatment and received pixantrone as the fifth or later round of chemotherapy.

The most common side effects observed with pixantrone were neutropenia, leukopenia, anemia, thrombocytopenia, asthenia, pyrexia, cough, decreased ejection fraction, and nausea. The most common grade 3 and 4 adverse events were hematologic.

The CHMP’s recommendation for conditional approval has been sent to the European Commission for the adoption of a European Union-wide decision. For more information on pixantrone’s approval, visit the EMA website.

Hospitalists keeping an eye on the planned implementation of the 10th revision of the International Statistical Classification of Diseases coding system (ICD-10) can breathe a temporary sigh of relief: The U.S. Department of Health and Human Services (HHS) announced last week that it would delay the October 2013 start date for using the new codes. No new date was given.

The decision came after the American Medical Association (AMA) launched a public campaign to persuade Congress and HHS to delay the transition to ICD-10. SHM's AMA delegate and public policy committee member Bradley Flansbaum, DO, MPH, SFHM, says SHM took no formal position on the start date but was watching the national discussion closely.

"This is a big jump," says Dr. Flansbaum, director of hospitalist services at Lenox Hill Hospital in New York City. "As always with administrative procedures and the legacy systems of yesteryear, a lot of institutions are pushing back."

At issue, according to AMA leaders, is that physicians already are dealing with a litany of regulatory, technological, and coding changes tied to the national healthcare reform movement. The immediate implementation quintuples the number of billing codes to 68,000, an expansion that would be an "onslaught of overlapping regulatory mandates and reporting requirements," wrote James Madara, MD, AMA executive vice president and chief executive officer, in a letter this month to HHS Secretary Kathleen Sebilius (PDF).

"ICD-10 codes are important to many positive improvements in our healthcare system," Sebilius said in announcing the delay. "We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead. We are committing to work with the provider community to re-examine the pace at which HHS and the nation implement these important improvements to our healthcare system."

Hospitalists keeping an eye on the planned implementation of the 10th revision of the International Statistical Classification of Diseases coding system (ICD-10) can breathe a temporary sigh of relief: The U.S. Department of Health and Human Services (HHS) announced last week that it would delay the October 2013 start date for using the new codes. No new date was given.

The decision came after the American Medical Association (AMA) launched a public campaign to persuade Congress and HHS to delay the transition to ICD-10. SHM's AMA delegate and public policy committee member Bradley Flansbaum, DO, MPH, SFHM, says SHM took no formal position on the start date but was watching the national discussion closely.

"This is a big jump," says Dr. Flansbaum, director of hospitalist services at Lenox Hill Hospital in New York City. "As always with administrative procedures and the legacy systems of yesteryear, a lot of institutions are pushing back."

At issue, according to AMA leaders, is that physicians already are dealing with a litany of regulatory, technological, and coding changes tied to the national healthcare reform movement. The immediate implementation quintuples the number of billing codes to 68,000, an expansion that would be an "onslaught of overlapping regulatory mandates and reporting requirements," wrote James Madara, MD, AMA executive vice president and chief executive officer, in a letter this month to HHS Secretary Kathleen Sebilius (PDF).

"ICD-10 codes are important to many positive improvements in our healthcare system," Sebilius said in announcing the delay. "We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead. We are committing to work with the provider community to re-examine the pace at which HHS and the nation implement these important improvements to our healthcare system."

Hospitalists keeping an eye on the planned implementation of the 10th revision of the International Statistical Classification of Diseases coding system (ICD-10) can breathe a temporary sigh of relief: The U.S. Department of Health and Human Services (HHS) announced last week that it would delay the October 2013 start date for using the new codes. No new date was given.

The decision came after the American Medical Association (AMA) launched a public campaign to persuade Congress and HHS to delay the transition to ICD-10. SHM's AMA delegate and public policy committee member Bradley Flansbaum, DO, MPH, SFHM, says SHM took no formal position on the start date but was watching the national discussion closely.

"This is a big jump," says Dr. Flansbaum, director of hospitalist services at Lenox Hill Hospital in New York City. "As always with administrative procedures and the legacy systems of yesteryear, a lot of institutions are pushing back."

At issue, according to AMA leaders, is that physicians already are dealing with a litany of regulatory, technological, and coding changes tied to the national healthcare reform movement. The immediate implementation quintuples the number of billing codes to 68,000, an expansion that would be an "onslaught of overlapping regulatory mandates and reporting requirements," wrote James Madara, MD, AMA executive vice president and chief executive officer, in a letter this month to HHS Secretary Kathleen Sebilius (PDF).

"ICD-10 codes are important to many positive improvements in our healthcare system," Sebilius said in announcing the delay. "We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead. We are committing to work with the provider community to re-examine the pace at which HHS and the nation implement these important improvements to our healthcare system."

Clinical question: In patients undergoing coronary and peripheral angiography, does acetylcysteine before and after the procedure protect the kidneys?

Background: Contrast-induced acute kidney injury is a serious complication of procedures that use iodinated contrast material and can lead to the need for dialysis, prolonged hospital stay, and increased cost and mortality. Acetylcysteine is thought to prevent this, but previous results from more than 40 trials conflict regarding its effectiveness.

Study design: Double-blinded randomized trial.

Setting: Forty-six centers in Brazil.

Synopsis: The study enrolled 2,308 patients with at least one risk factor for contrast-induced kidney injury and undergoing coronary or peripheral arterial diagnostic intravascular angiography or percutaneous intervention. Participants received two doses of acetylcysteine or placebo before and after contrast administration. End points included contrast-induced acute kidney injury, mortality, and the need for dialysis at 30 days.

Disappointingly, acetylcysteine did not significantly reduce the incidence of the end points in any patients, including the high-risk subgroups of those with diabetes mellitus and chronic renal failure, and those receiving the largest amounts of contrast. Limitations of the study include only a small number of events, as a larger number of events may help more accurately assess mortality and the need for dialysis. Additionally, creatinine may not be as good a marker for contrast-induced acute kidney injury as newer markers like cystatin C. The median volume of contrast used was low compared with previous studies, and cointerventions, such as hydration, were at the discretion of the attending physician.

Bottom line: Acetylcysteine use did not result in a lower incidence of contrast-induced acute kidney injury or other renal outcomes, and routine use prior to angiography is not recommended.

Citation: Berwange O, Cavalcanti AB, Sousa AG, et al. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized acetylcysteine for contrast-induced nephropathy trial (ACT). Circulation. 2011;124:1250-1259.

Clinical question: In patients undergoing coronary and peripheral angiography, does acetylcysteine before and after the procedure protect the kidneys?

Background: Contrast-induced acute kidney injury is a serious complication of procedures that use iodinated contrast material and can lead to the need for dialysis, prolonged hospital stay, and increased cost and mortality. Acetylcysteine is thought to prevent this, but previous results from more than 40 trials conflict regarding its effectiveness.

Study design: Double-blinded randomized trial.

Setting: Forty-six centers in Brazil.

Synopsis: The study enrolled 2,308 patients with at least one risk factor for contrast-induced kidney injury and undergoing coronary or peripheral arterial diagnostic intravascular angiography or percutaneous intervention. Participants received two doses of acetylcysteine or placebo before and after contrast administration. End points included contrast-induced acute kidney injury, mortality, and the need for dialysis at 30 days.

Disappointingly, acetylcysteine did not significantly reduce the incidence of the end points in any patients, including the high-risk subgroups of those with diabetes mellitus and chronic renal failure, and those receiving the largest amounts of contrast. Limitations of the study include only a small number of events, as a larger number of events may help more accurately assess mortality and the need for dialysis. Additionally, creatinine may not be as good a marker for contrast-induced acute kidney injury as newer markers like cystatin C. The median volume of contrast used was low compared with previous studies, and cointerventions, such as hydration, were at the discretion of the attending physician.

Bottom line: Acetylcysteine use did not result in a lower incidence of contrast-induced acute kidney injury or other renal outcomes, and routine use prior to angiography is not recommended.

Citation: Berwange O, Cavalcanti AB, Sousa AG, et al. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized acetylcysteine for contrast-induced nephropathy trial (ACT). Circulation. 2011;124:1250-1259.

Clinical question: In patients undergoing coronary and peripheral angiography, does acetylcysteine before and after the procedure protect the kidneys?

Background: Contrast-induced acute kidney injury is a serious complication of procedures that use iodinated contrast material and can lead to the need for dialysis, prolonged hospital stay, and increased cost and mortality. Acetylcysteine is thought to prevent this, but previous results from more than 40 trials conflict regarding its effectiveness.

Study design: Double-blinded randomized trial.

Setting: Forty-six centers in Brazil.

Synopsis: The study enrolled 2,308 patients with at least one risk factor for contrast-induced kidney injury and undergoing coronary or peripheral arterial diagnostic intravascular angiography or percutaneous intervention. Participants received two doses of acetylcysteine or placebo before and after contrast administration. End points included contrast-induced acute kidney injury, mortality, and the need for dialysis at 30 days.

Disappointingly, acetylcysteine did not significantly reduce the incidence of the end points in any patients, including the high-risk subgroups of those with diabetes mellitus and chronic renal failure, and those receiving the largest amounts of contrast. Limitations of the study include only a small number of events, as a larger number of events may help more accurately assess mortality and the need for dialysis. Additionally, creatinine may not be as good a marker for contrast-induced acute kidney injury as newer markers like cystatin C. The median volume of contrast used was low compared with previous studies, and cointerventions, such as hydration, were at the discretion of the attending physician.

Bottom line: Acetylcysteine use did not result in a lower incidence of contrast-induced acute kidney injury or other renal outcomes, and routine use prior to angiography is not recommended.

Citation: Berwange O, Cavalcanti AB, Sousa AG, et al. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized acetylcysteine for contrast-induced nephropathy trial (ACT). Circulation. 2011;124:1250-1259.

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.