The Child With Familial Hyperlipidemia

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Start with the most important thing—education of the child and the family. This condition is familial, so relatives are more likely to have this form of hyperlipidemia as well.

Ask families about relevant history of early heart disease. “Early familial heart disease” is defined as a father or grandfather younger than age 55 years and/or mother or grandmother younger than 65 years with known heart disease.

We recommend screening all children by the age of 2 years for relevant family history. Studies now indicate lipid deposits can start as early as this age.

Clinical intervention often is more about prevention than treatment. Unless children are homozygous for one of the genetic defects associated with familial hyperlipidemia, they may not have signs or symptoms until they reach their twenties or thirties.

It is appropriate for you to begin lifestyle recommendations with any overweight or obese child. Counsel the patient and family about better diet and exercise regimens. For example, instruct them to avoid fried foods and if they need to cook with oil, to use vegetable oil.

Recommend 60 minutes of moderate exercise daily. This does not have to be an hour all at once—it can be 20 minutes in the morning before the school bus comes, 20 minutes in the afternoon, and another 20 minutes in the evening. The physical activity does not have to be on the soccer field either. The patient can exercise by climbing the stairs or participating in a scavenger hunt at the mall.

The essential thing is getting the child off the couch and away from the computer. This is particularly important because many schools are cutting their physical education programs in this economy.

Emphasize to parents that familial hyperlipidemia is one of the preventable forms of heart disease. Parents have a choice if they want their children to lead long, healthy lives.

Monitor the child's growth. If the child exceeds the 95th percentile on the growth chart, draw cholesterol levels. If the numbers are high, initiate at least a 6-month trial of diet and exercise. If, after this time, the cholesterol levels remain high, consider prescribing a low-dose statin. If medication fails to reduce high cholesterol after 2 months, I recommend these children see a subspecialist like myself.

For the most part, they come to me obese and/or with high cholesterol. I lecture them like you cannot believe, and their weight and cholesterol numbers improve. For this reason, I have very few patients for whom I have to start medication.

The cholesterol assay you do has to be a fasting lipid profile, not a random cholesterol reading. A random test does not provide the most appropriate information. Use common sense regarding when to test kids. In other words, do not test cholesterol levels the day after their birthday, right after Halloween, or anytime between Thanksgiving and Christmas. Testing cholesterol at any time during spring and summer, if possible, is preferable.

You don't need to refer most children with familial hyperlipidemia for cardiac stress testing. Stress testing is generally reserved for treatment-refractory patients with established high cholesterol. This provides useful baseline information for children we cannot control well.

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Start with the most important thing—education of the child and the family. This condition is familial, so relatives are more likely to have this form of hyperlipidemia as well.

Ask families about relevant history of early heart disease. “Early familial heart disease” is defined as a father or grandfather younger than age 55 years and/or mother or grandmother younger than 65 years with known heart disease.

We recommend screening all children by the age of 2 years for relevant family history. Studies now indicate lipid deposits can start as early as this age.

Clinical intervention often is more about prevention than treatment. Unless children are homozygous for one of the genetic defects associated with familial hyperlipidemia, they may not have signs or symptoms until they reach their twenties or thirties.

It is appropriate for you to begin lifestyle recommendations with any overweight or obese child. Counsel the patient and family about better diet and exercise regimens. For example, instruct them to avoid fried foods and if they need to cook with oil, to use vegetable oil.

Recommend 60 minutes of moderate exercise daily. This does not have to be an hour all at once—it can be 20 minutes in the morning before the school bus comes, 20 minutes in the afternoon, and another 20 minutes in the evening. The physical activity does not have to be on the soccer field either. The patient can exercise by climbing the stairs or participating in a scavenger hunt at the mall.

The essential thing is getting the child off the couch and away from the computer. This is particularly important because many schools are cutting their physical education programs in this economy.

Emphasize to parents that familial hyperlipidemia is one of the preventable forms of heart disease. Parents have a choice if they want their children to lead long, healthy lives.

Monitor the child's growth. If the child exceeds the 95th percentile on the growth chart, draw cholesterol levels. If the numbers are high, initiate at least a 6-month trial of diet and exercise. If, after this time, the cholesterol levels remain high, consider prescribing a low-dose statin. If medication fails to reduce high cholesterol after 2 months, I recommend these children see a subspecialist like myself.

For the most part, they come to me obese and/or with high cholesterol. I lecture them like you cannot believe, and their weight and cholesterol numbers improve. For this reason, I have very few patients for whom I have to start medication.

The cholesterol assay you do has to be a fasting lipid profile, not a random cholesterol reading. A random test does not provide the most appropriate information. Use common sense regarding when to test kids. In other words, do not test cholesterol levels the day after their birthday, right after Halloween, or anytime between Thanksgiving and Christmas. Testing cholesterol at any time during spring and summer, if possible, is preferable.

You don't need to refer most children with familial hyperlipidemia for cardiac stress testing. Stress testing is generally reserved for treatment-refractory patients with established high cholesterol. This provides useful baseline information for children we cannot control well.

[email protected]

Start with the most important thing—education of the child and the family. This condition is familial, so relatives are more likely to have this form of hyperlipidemia as well.

Ask families about relevant history of early heart disease. “Early familial heart disease” is defined as a father or grandfather younger than age 55 years and/or mother or grandmother younger than 65 years with known heart disease.

We recommend screening all children by the age of 2 years for relevant family history. Studies now indicate lipid deposits can start as early as this age.

Clinical intervention often is more about prevention than treatment. Unless children are homozygous for one of the genetic defects associated with familial hyperlipidemia, they may not have signs or symptoms until they reach their twenties or thirties.

It is appropriate for you to begin lifestyle recommendations with any overweight or obese child. Counsel the patient and family about better diet and exercise regimens. For example, instruct them to avoid fried foods and if they need to cook with oil, to use vegetable oil.

Recommend 60 minutes of moderate exercise daily. This does not have to be an hour all at once—it can be 20 minutes in the morning before the school bus comes, 20 minutes in the afternoon, and another 20 minutes in the evening. The physical activity does not have to be on the soccer field either. The patient can exercise by climbing the stairs or participating in a scavenger hunt at the mall.

The essential thing is getting the child off the couch and away from the computer. This is particularly important because many schools are cutting their physical education programs in this economy.

Emphasize to parents that familial hyperlipidemia is one of the preventable forms of heart disease. Parents have a choice if they want their children to lead long, healthy lives.

Monitor the child's growth. If the child exceeds the 95th percentile on the growth chart, draw cholesterol levels. If the numbers are high, initiate at least a 6-month trial of diet and exercise. If, after this time, the cholesterol levels remain high, consider prescribing a low-dose statin. If medication fails to reduce high cholesterol after 2 months, I recommend these children see a subspecialist like myself.

For the most part, they come to me obese and/or with high cholesterol. I lecture them like you cannot believe, and their weight and cholesterol numbers improve. For this reason, I have very few patients for whom I have to start medication.

The cholesterol assay you do has to be a fasting lipid profile, not a random cholesterol reading. A random test does not provide the most appropriate information. Use common sense regarding when to test kids. In other words, do not test cholesterol levels the day after their birthday, right after Halloween, or anytime between Thanksgiving and Christmas. Testing cholesterol at any time during spring and summer, if possible, is preferable.

You don't need to refer most children with familial hyperlipidemia for cardiac stress testing. Stress testing is generally reserved for treatment-refractory patients with established high cholesterol. This provides useful baseline information for children we cannot control well.

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Managing Acid-Related Disorders Through the Ages of Mankind

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Managing Acid-Related Disorders Through the Ages of Mankind

A supplement to Internal Medicine News supported by a restricted grant from TAP Pharmaceutical Products, Inc.
Symposium Highlights of articles based on presentations given at a continuing medical education symposium held on October 22, 2002, in Seattle, Wash.





To view the supplement, click the image above.


INTRODUCTION
A.Mark Fendrick, MD
Associate Professor of Internal Medicine, Health Management & Policy
University of Michigan Medical Center
Ann Arbor, MI
Research Grants: TAP Pharmaceutical Products, Inc., Procter & Gamble Company, Merck & Co., Inc.; Consultant: TAP, AstraZeneca, Procter & Gamble, McNeil-PPC, Inc., Merck; Speaker: TAP.

GERD OFTEN OVERLOOKED IN PEDIATRIC PATIENTS
Harland S. Winter, MD
Director, Pediatric Inflammatory Bowel Disease Center
Massachusetts General Hospital for Children
Harvard Medical School
Boston, MA
Grants: Procter & Gamble, AstraZeneca, TAP, Wyeth, Centocor, Inc., Elan, Con Agra; Research Support: Procter & Gamble, the Anneberg Center; Consultant: AstraZeneca, Wyeth.

PROTON PUMP INHIBITORS REMAIN STANDARD FOR GERD
Richard H. Hunt, FRCP, FRCP(C), FACG
Professor of Medicine
McMaster University Medical Centre
Hamilton, Ont.
Consultant: Abbott Laboratories, Axcan Pharma Inc., AstraZeneca, Merck & Co., Novartis Pharmaceuticals Corp., Procter & Gamble Co., TAP Pharmaceutical Products, Inc.; Investigator: Axcan, AstraZeneca, Merck, TAP.

HEALING AND PREVENTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN ELDERLY PATIENTS
David A. Peura, MD, FACG, FACP
Professor of Medicine
University of Virginia Health Sciences Center
Charlottesville, VA
Speaker: TAP, AstraZeneca, Wyeth, McNeil, Merck.

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A supplement to Internal Medicine News supported by a restricted grant from TAP Pharmaceutical Products, Inc.
Symposium Highlights of articles based on presentations given at a continuing medical education symposium held on October 22, 2002, in Seattle, Wash.





To view the supplement, click the image above.


INTRODUCTION
A.Mark Fendrick, MD
Associate Professor of Internal Medicine, Health Management & Policy
University of Michigan Medical Center
Ann Arbor, MI
Research Grants: TAP Pharmaceutical Products, Inc., Procter & Gamble Company, Merck & Co., Inc.; Consultant: TAP, AstraZeneca, Procter & Gamble, McNeil-PPC, Inc., Merck; Speaker: TAP.

GERD OFTEN OVERLOOKED IN PEDIATRIC PATIENTS
Harland S. Winter, MD
Director, Pediatric Inflammatory Bowel Disease Center
Massachusetts General Hospital for Children
Harvard Medical School
Boston, MA
Grants: Procter & Gamble, AstraZeneca, TAP, Wyeth, Centocor, Inc., Elan, Con Agra; Research Support: Procter & Gamble, the Anneberg Center; Consultant: AstraZeneca, Wyeth.

PROTON PUMP INHIBITORS REMAIN STANDARD FOR GERD
Richard H. Hunt, FRCP, FRCP(C), FACG
Professor of Medicine
McMaster University Medical Centre
Hamilton, Ont.
Consultant: Abbott Laboratories, Axcan Pharma Inc., AstraZeneca, Merck & Co., Novartis Pharmaceuticals Corp., Procter & Gamble Co., TAP Pharmaceutical Products, Inc.; Investigator: Axcan, AstraZeneca, Merck, TAP.

HEALING AND PREVENTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN ELDERLY PATIENTS
David A. Peura, MD, FACG, FACP
Professor of Medicine
University of Virginia Health Sciences Center
Charlottesville, VA
Speaker: TAP, AstraZeneca, Wyeth, McNeil, Merck.

A supplement to Internal Medicine News supported by a restricted grant from TAP Pharmaceutical Products, Inc.
Symposium Highlights of articles based on presentations given at a continuing medical education symposium held on October 22, 2002, in Seattle, Wash.





To view the supplement, click the image above.


INTRODUCTION
A.Mark Fendrick, MD
Associate Professor of Internal Medicine, Health Management & Policy
University of Michigan Medical Center
Ann Arbor, MI
Research Grants: TAP Pharmaceutical Products, Inc., Procter & Gamble Company, Merck & Co., Inc.; Consultant: TAP, AstraZeneca, Procter & Gamble, McNeil-PPC, Inc., Merck; Speaker: TAP.

GERD OFTEN OVERLOOKED IN PEDIATRIC PATIENTS
Harland S. Winter, MD
Director, Pediatric Inflammatory Bowel Disease Center
Massachusetts General Hospital for Children
Harvard Medical School
Boston, MA
Grants: Procter & Gamble, AstraZeneca, TAP, Wyeth, Centocor, Inc., Elan, Con Agra; Research Support: Procter & Gamble, the Anneberg Center; Consultant: AstraZeneca, Wyeth.

PROTON PUMP INHIBITORS REMAIN STANDARD FOR GERD
Richard H. Hunt, FRCP, FRCP(C), FACG
Professor of Medicine
McMaster University Medical Centre
Hamilton, Ont.
Consultant: Abbott Laboratories, Axcan Pharma Inc., AstraZeneca, Merck & Co., Novartis Pharmaceuticals Corp., Procter & Gamble Co., TAP Pharmaceutical Products, Inc.; Investigator: Axcan, AstraZeneca, Merck, TAP.

HEALING AND PREVENTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN ELDERLY PATIENTS
David A. Peura, MD, FACG, FACP
Professor of Medicine
University of Virginia Health Sciences Center
Charlottesville, VA
Speaker: TAP, AstraZeneca, Wyeth, McNeil, Merck.

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Increased Elderly Care Costs Linked to Length of Stay

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The latest wave of data confirming that end-of-life care is an outsized driver of healthcare costs comes with one caveat from the chair of SHM’s research committee.

“It’s not always obvious you’re providing end-of-life care when you’re providing it,” says David Meltzer, MD, PhD, FHM, FACP, chief of the section of hospital medicine and associate professor in the Department of Medicine and the Graduate School of Public Policy Studies at the University of Chicago. “You have to be really careful not to conflate age and proximity to death.”

Dr. Meltzer was one of the lead investigators who helped develop the university’s Curriculum for the Hospitalized Aging Medical Patient (CHAMP) and has studied the costs of healthcare delivery to the elderly. He cautions hospitalists against couching cost calculations in terms of the age of their patient census—and reviewing instead what would improve a patient’s quality of life.

“There are times when it’s appropriate to discuss the goals of care,” Dr. Meltzer says. “I doubt the answer to that question is defined by age.”

Accordingly, a statistical brief released last month by the federal Agency of Healthcare Research and Quality (AHRQ) focused on cost drivers, not age. The data show the inpatient death rate in 2007 was 1.9%. “However, these hospital stays ending in death were responsible for 5.2% ($20 billion) of all hospital inpatient costs,” the brief concluded. In what is probably no surprise to hospitalists, much of that cost is traced to length of stay, which averaged 8.8 days for patients who died and 4.5 days for those who lived. The data is for 2007, the latest year available.

To counter rising costs, Dr. Meltzer recommends:  

 

  • Review a patient’s condition holistically, looking past age;
  •  

  • Have an upfront discussion with the patient about what their expectations of care are. Avoid excess care that is not in line with the patient’s wishes; and
  •  

  • Talk with hospital administration to ensure that your HM group has a say in care decisions, effectively giving hospitalists an opportunity to act as a change agent.

 

“It’s not so much measuring against cost; it’s measuring against the patient’s preferences,” Dr. Meltzer says. “Ultimately, the physician is the patient’s agent.”

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The latest wave of data confirming that end-of-life care is an outsized driver of healthcare costs comes with one caveat from the chair of SHM’s research committee.

“It’s not always obvious you’re providing end-of-life care when you’re providing it,” says David Meltzer, MD, PhD, FHM, FACP, chief of the section of hospital medicine and associate professor in the Department of Medicine and the Graduate School of Public Policy Studies at the University of Chicago. “You have to be really careful not to conflate age and proximity to death.”

Dr. Meltzer was one of the lead investigators who helped develop the university’s Curriculum for the Hospitalized Aging Medical Patient (CHAMP) and has studied the costs of healthcare delivery to the elderly. He cautions hospitalists against couching cost calculations in terms of the age of their patient census—and reviewing instead what would improve a patient’s quality of life.

“There are times when it’s appropriate to discuss the goals of care,” Dr. Meltzer says. “I doubt the answer to that question is defined by age.”

Accordingly, a statistical brief released last month by the federal Agency of Healthcare Research and Quality (AHRQ) focused on cost drivers, not age. The data show the inpatient death rate in 2007 was 1.9%. “However, these hospital stays ending in death were responsible for 5.2% ($20 billion) of all hospital inpatient costs,” the brief concluded. In what is probably no surprise to hospitalists, much of that cost is traced to length of stay, which averaged 8.8 days for patients who died and 4.5 days for those who lived. The data is for 2007, the latest year available.

To counter rising costs, Dr. Meltzer recommends:  

 

  • Review a patient’s condition holistically, looking past age;
  •  

  • Have an upfront discussion with the patient about what their expectations of care are. Avoid excess care that is not in line with the patient’s wishes; and
  •  

  • Talk with hospital administration to ensure that your HM group has a say in care decisions, effectively giving hospitalists an opportunity to act as a change agent.

 

“It’s not so much measuring against cost; it’s measuring against the patient’s preferences,” Dr. Meltzer says. “Ultimately, the physician is the patient’s agent.”

The latest wave of data confirming that end-of-life care is an outsized driver of healthcare costs comes with one caveat from the chair of SHM’s research committee.

“It’s not always obvious you’re providing end-of-life care when you’re providing it,” says David Meltzer, MD, PhD, FHM, FACP, chief of the section of hospital medicine and associate professor in the Department of Medicine and the Graduate School of Public Policy Studies at the University of Chicago. “You have to be really careful not to conflate age and proximity to death.”

Dr. Meltzer was one of the lead investigators who helped develop the university’s Curriculum for the Hospitalized Aging Medical Patient (CHAMP) and has studied the costs of healthcare delivery to the elderly. He cautions hospitalists against couching cost calculations in terms of the age of their patient census—and reviewing instead what would improve a patient’s quality of life.

“There are times when it’s appropriate to discuss the goals of care,” Dr. Meltzer says. “I doubt the answer to that question is defined by age.”

Accordingly, a statistical brief released last month by the federal Agency of Healthcare Research and Quality (AHRQ) focused on cost drivers, not age. The data show the inpatient death rate in 2007 was 1.9%. “However, these hospital stays ending in death were responsible for 5.2% ($20 billion) of all hospital inpatient costs,” the brief concluded. In what is probably no surprise to hospitalists, much of that cost is traced to length of stay, which averaged 8.8 days for patients who died and 4.5 days for those who lived. The data is for 2007, the latest year available.

To counter rising costs, Dr. Meltzer recommends:  

 

  • Review a patient’s condition holistically, looking past age;
  •  

  • Have an upfront discussion with the patient about what their expectations of care are. Avoid excess care that is not in line with the patient’s wishes; and
  •  

  • Talk with hospital administration to ensure that your HM group has a say in care decisions, effectively giving hospitalists an opportunity to act as a change agent.

 

“It’s not so much measuring against cost; it’s measuring against the patient’s preferences,” Dr. Meltzer says. “Ultimately, the physician is the patient’s agent.”

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In the Literature: The Latest Research You Need to Know

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Clinical question: Does the new antiarrhythmic agent dronedarone, an amiodarone derivative, reduce the incidence of stroke in patients with persistent or paroxysmal atrial fibrillation and at least one risk factor for vascular events?

Background: Antiarrhythmic therapy has not been shown to reduce stroke risk in the treatment of chronic atrial fibrillation. A sub-group analysis of a recent multicentered, international, industry-sponsored, randomized trial of the new antiarrhythmic dronedarone, suggested a potential reduction in stroke risk when compared with placebo.

Study design: Post-hoc analysis of a previous prospective, randomized, placebo-controlled, double-blinded, parallel-arm trial.

Setting: 551 centers in 37 countries.

Synopsis: In addition to anticoagulation and rate control, 4,628 patients with atrial fibrillation and at least one risk factor for cardiovascular (CV) hospitalization were randomized to dronedarone versus placebo. The study assessed the primary outcomes of stroke, acute coronary syndromes, CV, and total mortality.

The dronedarone arm experienced a 0.6% absolute risk reduction (ARR) of stroke {(number-needed-to-treat (NNT) 167); relative risk reduction (RRR) 33%; P=0.027}; 0.7% ARR of “stroke or transient ischemic attack” (NNT 143; RRR 30%; P=0.031); 1.7% ARR of “stroke, ACS, or CV death,” (NNT 59; RRR 31%; P<0.001); and a 1.6% ARR of “stroke, ACS, or all-cause mortality” (NNT 63; RRR 24%; P=0.002). In further subgroup analysis, only the 65% of patients had CHADS2 scores =2, benefited (RR stroke 0.50; 95% CI, 0.32-0.79).

The results are thought-provoking, and suggest there could be more than antiarrhythmic effects of dronedarone (such as antithrombotic, antihypertensive, or neuroprotective effects). However, given the limitations of the study (post-hoc analysis, an unclear mechanism of action, and strokes were not adjudicated) and suggests somewhat different conclusions than the prior AFFIRM trial (NEJM 2002;347:1825), which looked at rate versus rhythm control in patients on the parent drug amiodarone, and was not associated with decreased risk of stroke, more research is needed.

Bottom line: At present, the mainstay of stroke prevention in atrial fibrillation should remain rate control, anticoagulants, and antiplatelet agents.

Citation: Connolly SJ, Crijns HJ, Torp-Pedersen C, et al. Analysis of stroke in ATHENA: a placebo-controlled, double-blinded, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter. Circulation. 2009;120(13):1174-1180.

Reviewed for TH eWire by Bhaskar Arora, MD, Thomas Barrett, MD, MCR, FHM, Honora Englander, MD, Stephanie Halvorson, MD, Alan J. Hunter, MD, David Kagen, MD, Blake Lesselroth, MD, MBI, Portland Veterans Affairs Medical Center and Division of Hospital Medicine, Oregon Health & Science University.

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Clinical question: Does the new antiarrhythmic agent dronedarone, an amiodarone derivative, reduce the incidence of stroke in patients with persistent or paroxysmal atrial fibrillation and at least one risk factor for vascular events?

Background: Antiarrhythmic therapy has not been shown to reduce stroke risk in the treatment of chronic atrial fibrillation. A sub-group analysis of a recent multicentered, international, industry-sponsored, randomized trial of the new antiarrhythmic dronedarone, suggested a potential reduction in stroke risk when compared with placebo.

Study design: Post-hoc analysis of a previous prospective, randomized, placebo-controlled, double-blinded, parallel-arm trial.

Setting: 551 centers in 37 countries.

Synopsis: In addition to anticoagulation and rate control, 4,628 patients with atrial fibrillation and at least one risk factor for cardiovascular (CV) hospitalization were randomized to dronedarone versus placebo. The study assessed the primary outcomes of stroke, acute coronary syndromes, CV, and total mortality.

The dronedarone arm experienced a 0.6% absolute risk reduction (ARR) of stroke {(number-needed-to-treat (NNT) 167); relative risk reduction (RRR) 33%; P=0.027}; 0.7% ARR of “stroke or transient ischemic attack” (NNT 143; RRR 30%; P=0.031); 1.7% ARR of “stroke, ACS, or CV death,” (NNT 59; RRR 31%; P<0.001); and a 1.6% ARR of “stroke, ACS, or all-cause mortality” (NNT 63; RRR 24%; P=0.002). In further subgroup analysis, only the 65% of patients had CHADS2 scores =2, benefited (RR stroke 0.50; 95% CI, 0.32-0.79).

The results are thought-provoking, and suggest there could be more than antiarrhythmic effects of dronedarone (such as antithrombotic, antihypertensive, or neuroprotective effects). However, given the limitations of the study (post-hoc analysis, an unclear mechanism of action, and strokes were not adjudicated) and suggests somewhat different conclusions than the prior AFFIRM trial (NEJM 2002;347:1825), which looked at rate versus rhythm control in patients on the parent drug amiodarone, and was not associated with decreased risk of stroke, more research is needed.

Bottom line: At present, the mainstay of stroke prevention in atrial fibrillation should remain rate control, anticoagulants, and antiplatelet agents.

Citation: Connolly SJ, Crijns HJ, Torp-Pedersen C, et al. Analysis of stroke in ATHENA: a placebo-controlled, double-blinded, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter. Circulation. 2009;120(13):1174-1180.

Reviewed for TH eWire by Bhaskar Arora, MD, Thomas Barrett, MD, MCR, FHM, Honora Englander, MD, Stephanie Halvorson, MD, Alan J. Hunter, MD, David Kagen, MD, Blake Lesselroth, MD, MBI, Portland Veterans Affairs Medical Center and Division of Hospital Medicine, Oregon Health & Science University.

Clinical question: Does the new antiarrhythmic agent dronedarone, an amiodarone derivative, reduce the incidence of stroke in patients with persistent or paroxysmal atrial fibrillation and at least one risk factor for vascular events?

Background: Antiarrhythmic therapy has not been shown to reduce stroke risk in the treatment of chronic atrial fibrillation. A sub-group analysis of a recent multicentered, international, industry-sponsored, randomized trial of the new antiarrhythmic dronedarone, suggested a potential reduction in stroke risk when compared with placebo.

Study design: Post-hoc analysis of a previous prospective, randomized, placebo-controlled, double-blinded, parallel-arm trial.

Setting: 551 centers in 37 countries.

Synopsis: In addition to anticoagulation and rate control, 4,628 patients with atrial fibrillation and at least one risk factor for cardiovascular (CV) hospitalization were randomized to dronedarone versus placebo. The study assessed the primary outcomes of stroke, acute coronary syndromes, CV, and total mortality.

The dronedarone arm experienced a 0.6% absolute risk reduction (ARR) of stroke {(number-needed-to-treat (NNT) 167); relative risk reduction (RRR) 33%; P=0.027}; 0.7% ARR of “stroke or transient ischemic attack” (NNT 143; RRR 30%; P=0.031); 1.7% ARR of “stroke, ACS, or CV death,” (NNT 59; RRR 31%; P<0.001); and a 1.6% ARR of “stroke, ACS, or all-cause mortality” (NNT 63; RRR 24%; P=0.002). In further subgroup analysis, only the 65% of patients had CHADS2 scores =2, benefited (RR stroke 0.50; 95% CI, 0.32-0.79).

The results are thought-provoking, and suggest there could be more than antiarrhythmic effects of dronedarone (such as antithrombotic, antihypertensive, or neuroprotective effects). However, given the limitations of the study (post-hoc analysis, an unclear mechanism of action, and strokes were not adjudicated) and suggests somewhat different conclusions than the prior AFFIRM trial (NEJM 2002;347:1825), which looked at rate versus rhythm control in patients on the parent drug amiodarone, and was not associated with decreased risk of stroke, more research is needed.

Bottom line: At present, the mainstay of stroke prevention in atrial fibrillation should remain rate control, anticoagulants, and antiplatelet agents.

Citation: Connolly SJ, Crijns HJ, Torp-Pedersen C, et al. Analysis of stroke in ATHENA: a placebo-controlled, double-blinded, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter. Circulation. 2009;120(13):1174-1180.

Reviewed for TH eWire by Bhaskar Arora, MD, Thomas Barrett, MD, MCR, FHM, Honora Englander, MD, Stephanie Halvorson, MD, Alan J. Hunter, MD, David Kagen, MD, Blake Lesselroth, MD, MBI, Portland Veterans Affairs Medical Center and Division of Hospital Medicine, Oregon Health & Science University.

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Congress Gets Defensive with Medicare Payments

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Congressional action has delayed a potentially devastating cut in Medicare physician reimbursements for at least two more months, while a separate attempt to delay the looming elimination of Medicare’s consultation billing codes now seems increasingly unlikely to succeed.

In November, the House of Representatives passed a bill that would have rescinded the 21.2% cut to Medicare’s physician fee schedule for 2010 (dictated by the current formula’s sustainable growth rate, or SGR). But the Senate balked at the expected $247 billion price tag, and was unable to muster enough votes to avert a filibuster.

Trying a different tack, House Democrats used the must-pass Defense appropriations bill to push through an amendment freezing Medicare payments at current levels through February, buying Congress more time to find a better solution. The Senate followed suit by approving the bill on Saturday, though a longer-term fix is still in flux. A joint letter by SHM, the American Medical Association (AMA), and other physicians groups calls for a permanent end to the SGR formula—a potentially contentious issue that will await Congress in 2010.

Meanwhile, a request from the AMA and other physician groups to delay the elimination of Medicare consultation codes for a year to allow more time for guidance and ironing out technical issues has yielded no guarantees from the Centers for Medicare and Medicaid Services (CMS). Sen. Arlen Specter (D-Penn.) had offered an amendment seeking such a delay to the Senate’s healthcare reform legislation, but a spokesperson from Spector's office said the amendment did not move forward with the Senate bill—an exclusion that now makes a last-minute reprieve unlikely.

In the interim, CMS has released a 29-page transmittal explaining how the eliminated codes will be replaced by existing evaluation and management codes. Click here to download a PDF of the transmittal.

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Congressional action has delayed a potentially devastating cut in Medicare physician reimbursements for at least two more months, while a separate attempt to delay the looming elimination of Medicare’s consultation billing codes now seems increasingly unlikely to succeed.

In November, the House of Representatives passed a bill that would have rescinded the 21.2% cut to Medicare’s physician fee schedule for 2010 (dictated by the current formula’s sustainable growth rate, or SGR). But the Senate balked at the expected $247 billion price tag, and was unable to muster enough votes to avert a filibuster.

Trying a different tack, House Democrats used the must-pass Defense appropriations bill to push through an amendment freezing Medicare payments at current levels through February, buying Congress more time to find a better solution. The Senate followed suit by approving the bill on Saturday, though a longer-term fix is still in flux. A joint letter by SHM, the American Medical Association (AMA), and other physicians groups calls for a permanent end to the SGR formula—a potentially contentious issue that will await Congress in 2010.

Meanwhile, a request from the AMA and other physician groups to delay the elimination of Medicare consultation codes for a year to allow more time for guidance and ironing out technical issues has yielded no guarantees from the Centers for Medicare and Medicaid Services (CMS). Sen. Arlen Specter (D-Penn.) had offered an amendment seeking such a delay to the Senate’s healthcare reform legislation, but a spokesperson from Spector's office said the amendment did not move forward with the Senate bill—an exclusion that now makes a last-minute reprieve unlikely.

In the interim, CMS has released a 29-page transmittal explaining how the eliminated codes will be replaced by existing evaluation and management codes. Click here to download a PDF of the transmittal.

Congressional action has delayed a potentially devastating cut in Medicare physician reimbursements for at least two more months, while a separate attempt to delay the looming elimination of Medicare’s consultation billing codes now seems increasingly unlikely to succeed.

In November, the House of Representatives passed a bill that would have rescinded the 21.2% cut to Medicare’s physician fee schedule for 2010 (dictated by the current formula’s sustainable growth rate, or SGR). But the Senate balked at the expected $247 billion price tag, and was unable to muster enough votes to avert a filibuster.

Trying a different tack, House Democrats used the must-pass Defense appropriations bill to push through an amendment freezing Medicare payments at current levels through February, buying Congress more time to find a better solution. The Senate followed suit by approving the bill on Saturday, though a longer-term fix is still in flux. A joint letter by SHM, the American Medical Association (AMA), and other physicians groups calls for a permanent end to the SGR formula—a potentially contentious issue that will await Congress in 2010.

Meanwhile, a request from the AMA and other physician groups to delay the elimination of Medicare consultation codes for a year to allow more time for guidance and ironing out technical issues has yielded no guarantees from the Centers for Medicare and Medicaid Services (CMS). Sen. Arlen Specter (D-Penn.) had offered an amendment seeking such a delay to the Senate’s healthcare reform legislation, but a spokesperson from Spector's office said the amendment did not move forward with the Senate bill—an exclusion that now makes a last-minute reprieve unlikely.

In the interim, CMS has released a 29-page transmittal explaining how the eliminated codes will be replaced by existing evaluation and management codes. Click here to download a PDF of the transmittal.

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Congress Gets Defensive with Medicare Payments
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Project BOOST Expansion Planned

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Project BOOST (Better Outcomes for Older Adults through Safer Transitions) is getting, well, a pretty big boost in 2010.

The pilot transitional-care program implemented at 30 sites in the past 18 months pairs SHM mentors with hospitalists to improve care via a discharge planning toolkit. Preliminary plans call for up to 45 additional sites staggered over three cohorts in the next 12 months.

Tina Budnitz, MPH, SHM senior advisor and director of Project BOOST, says the initiative also is working to create a tuition-based model, planning an educational Web-based seminar and standardized “teachback” materials. The BOOST team also is promoting an Internet listserv that hospitalists at the debut sites have used as a communal communication tool.

“It is a big jump,” Budnitz acknowledges. “We think the secret sauce that’s made it work so far will be able to scale.”

Quantifiable data from the first six sites, which were selected for the program in the summer of 2008, could be released this spring. A lack of metrics, however, has done little to stymie the initiative’s growth. Two sites—Hospital of the University of Pennsylvania in Philadelphia and St. Mary’s Health Center in St. Louis, Mo.—already have won safety awards related to the program.

One of the program’s mentors says the early success can be tied to hospitalists’ commitment to using the toolkit as the basis of a transitional-care upgrade, instead of expecting the program’s presence alone to improve care.

“It’s way more than what is BOOST and ‘how are we going to implement?’ ” says Janet Nagamine, MD, FHM, hospitalist at Kaiser Permanente in Santa Clara, Calif., SHM board member, and chair of SHM’s Hospital Quality and Patient Safety Committee. “They have really looked at their entire discharge process and done a lot of looking at their individual and specific challenges and how to overcome them.”

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Project BOOST (Better Outcomes for Older Adults through Safer Transitions) is getting, well, a pretty big boost in 2010.

The pilot transitional-care program implemented at 30 sites in the past 18 months pairs SHM mentors with hospitalists to improve care via a discharge planning toolkit. Preliminary plans call for up to 45 additional sites staggered over three cohorts in the next 12 months.

Tina Budnitz, MPH, SHM senior advisor and director of Project BOOST, says the initiative also is working to create a tuition-based model, planning an educational Web-based seminar and standardized “teachback” materials. The BOOST team also is promoting an Internet listserv that hospitalists at the debut sites have used as a communal communication tool.

“It is a big jump,” Budnitz acknowledges. “We think the secret sauce that’s made it work so far will be able to scale.”

Quantifiable data from the first six sites, which were selected for the program in the summer of 2008, could be released this spring. A lack of metrics, however, has done little to stymie the initiative’s growth. Two sites—Hospital of the University of Pennsylvania in Philadelphia and St. Mary’s Health Center in St. Louis, Mo.—already have won safety awards related to the program.

One of the program’s mentors says the early success can be tied to hospitalists’ commitment to using the toolkit as the basis of a transitional-care upgrade, instead of expecting the program’s presence alone to improve care.

“It’s way more than what is BOOST and ‘how are we going to implement?’ ” says Janet Nagamine, MD, FHM, hospitalist at Kaiser Permanente in Santa Clara, Calif., SHM board member, and chair of SHM’s Hospital Quality and Patient Safety Committee. “They have really looked at their entire discharge process and done a lot of looking at their individual and specific challenges and how to overcome them.”

Project BOOST (Better Outcomes for Older Adults through Safer Transitions) is getting, well, a pretty big boost in 2010.

The pilot transitional-care program implemented at 30 sites in the past 18 months pairs SHM mentors with hospitalists to improve care via a discharge planning toolkit. Preliminary plans call for up to 45 additional sites staggered over three cohorts in the next 12 months.

Tina Budnitz, MPH, SHM senior advisor and director of Project BOOST, says the initiative also is working to create a tuition-based model, planning an educational Web-based seminar and standardized “teachback” materials. The BOOST team also is promoting an Internet listserv that hospitalists at the debut sites have used as a communal communication tool.

“It is a big jump,” Budnitz acknowledges. “We think the secret sauce that’s made it work so far will be able to scale.”

Quantifiable data from the first six sites, which were selected for the program in the summer of 2008, could be released this spring. A lack of metrics, however, has done little to stymie the initiative’s growth. Two sites—Hospital of the University of Pennsylvania in Philadelphia and St. Mary’s Health Center in St. Louis, Mo.—already have won safety awards related to the program.

One of the program’s mentors says the early success can be tied to hospitalists’ commitment to using the toolkit as the basis of a transitional-care upgrade, instead of expecting the program’s presence alone to improve care.

“It’s way more than what is BOOST and ‘how are we going to implement?’ ” says Janet Nagamine, MD, FHM, hospitalist at Kaiser Permanente in Santa Clara, Calif., SHM board member, and chair of SHM’s Hospital Quality and Patient Safety Committee. “They have really looked at their entire discharge process and done a lot of looking at their individual and specific challenges and how to overcome them.”

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CML Treatment: Old Drug, New Name

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There's a new old drug for chronic myeloid leukemia, and it seems to work in patients who don't respond to any of the approved therapies for this disease. Dr. Jorge Cortes discusses the potential of omacetaxine mepesuccinate at the annual meeting of the American Society of Hematology.

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There's a new old drug for chronic myeloid leukemia, and it seems to work in patients who don't respond to any of the approved therapies for this disease. Dr. Jorge Cortes discusses the potential of omacetaxine mepesuccinate at the annual meeting of the American Society of Hematology.

There's a new old drug for chronic myeloid leukemia, and it seems to work in patients who don't respond to any of the approved therapies for this disease. Dr. Jorge Cortes discusses the potential of omacetaxine mepesuccinate at the annual meeting of the American Society of Hematology.

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Multiple Myeloma in the Elderly

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In the VISTA trial, the Spanish Myeloma Group created an induction regimen of bortezomib, melphalan, and prednisone that elderly patients could tolerate. This year the group took that regimen a step further.

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In the VISTA trial, the Spanish Myeloma Group created an induction regimen of bortezomib, melphalan, and prednisone that elderly patients could tolerate. This year the group took that regimen a step further.

In the VISTA trial, the Spanish Myeloma Group created an induction regimen of bortezomib, melphalan, and prednisone that elderly patients could tolerate. This year the group took that regimen a step further.

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First-Line Lymphoma Treatments

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First-Line Lymphoma Treatments

Bendamustine plus rituximab has the potential to replace standard CHOP chemotherapy plus rituximab in the first-line treatment of advanced lymphomas. Dr. Mathias J. Rummel discusses data presented at the annual meeting of the American Society of Hematology.

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Bendamustine plus rituximab has the potential to replace standard CHOP chemotherapy plus rituximab in the first-line treatment of advanced lymphomas. Dr. Mathias J. Rummel discusses data presented at the annual meeting of the American Society of Hematology.

Bendamustine plus rituximab has the potential to replace standard CHOP chemotherapy plus rituximab in the first-line treatment of advanced lymphomas. Dr. Mathias J. Rummel discusses data presented at the annual meeting of the American Society of Hematology.

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Medical Journals Make Proactive Move

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Many of the medical journals read most by hospitalists, including the New England Journal of Medicine and the Journal of the American Medical Association, are adopting a new set of guidelines for the disclosure of potential conflicts of interest, a move the journals and researchers say is a step toward further transparency of authors' competing loyalties.

"From the perspective of an investigator and an end-user of the scientific literature, this is a positive development," says Andrew Masica, MD, MSCI, FHM, director of clinical effectiveness at Baylor Health Care System in Waco, Texas. "In many cases, a work's biggest impact is at the time of its initial release. It is important to provide full information on potential conflicts of interest at this early stage, rather than having something disclosed further down the road."

The new reporting guidelines were introduced in the fall by the International Committee of Medical Journal Editors and are being phased in at member journals. Authors will be asked to disclose four types of information, according to an NEJM editorial:1

  • Financial associations tied to the study they worked on; 

     

  • Financial ties that could have an "interest in the general area of the submitted manuscript;" 

     

  • Similar financial associations involving spouses and children under 18 years of age; and

     

  • Relevant nonfinancial associations.
  •  

The new rules "align well with the overall trend towards transparency in healthcare," says Dr. Masica, who published this year in the Journal of Hospital Medicine. "Safety and quality data at both the hospital and practitioner level are increasingly available to the public; consistency with disclosure helps move research toward that same standard."

To that end, JHM is updating its peer-review submission Web site to incorporate the new changes and expects to make an announcement on its progress in April. "Transparency is good for healthcare delivery and establishing trust with our primary focus—the care of hospitalized patients," says Mark V. Williams, MD, FACP, FHM, JHM editor-in-chief.

Download the new ICMJE disclosure form and view completed samples.

Reference

1. Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816-823.

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Many of the medical journals read most by hospitalists, including the New England Journal of Medicine and the Journal of the American Medical Association, are adopting a new set of guidelines for the disclosure of potential conflicts of interest, a move the journals and researchers say is a step toward further transparency of authors' competing loyalties.

"From the perspective of an investigator and an end-user of the scientific literature, this is a positive development," says Andrew Masica, MD, MSCI, FHM, director of clinical effectiveness at Baylor Health Care System in Waco, Texas. "In many cases, a work's biggest impact is at the time of its initial release. It is important to provide full information on potential conflicts of interest at this early stage, rather than having something disclosed further down the road."

The new reporting guidelines were introduced in the fall by the International Committee of Medical Journal Editors and are being phased in at member journals. Authors will be asked to disclose four types of information, according to an NEJM editorial:1

  • Financial associations tied to the study they worked on; 

     

  • Financial ties that could have an "interest in the general area of the submitted manuscript;" 

     

  • Similar financial associations involving spouses and children under 18 years of age; and

     

  • Relevant nonfinancial associations.
  •  

The new rules "align well with the overall trend towards transparency in healthcare," says Dr. Masica, who published this year in the Journal of Hospital Medicine. "Safety and quality data at both the hospital and practitioner level are increasingly available to the public; consistency with disclosure helps move research toward that same standard."

To that end, JHM is updating its peer-review submission Web site to incorporate the new changes and expects to make an announcement on its progress in April. "Transparency is good for healthcare delivery and establishing trust with our primary focus—the care of hospitalized patients," says Mark V. Williams, MD, FACP, FHM, JHM editor-in-chief.

Download the new ICMJE disclosure form and view completed samples.

Reference

1. Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816-823.

Many of the medical journals read most by hospitalists, including the New England Journal of Medicine and the Journal of the American Medical Association, are adopting a new set of guidelines for the disclosure of potential conflicts of interest, a move the journals and researchers say is a step toward further transparency of authors' competing loyalties.

"From the perspective of an investigator and an end-user of the scientific literature, this is a positive development," says Andrew Masica, MD, MSCI, FHM, director of clinical effectiveness at Baylor Health Care System in Waco, Texas. "In many cases, a work's biggest impact is at the time of its initial release. It is important to provide full information on potential conflicts of interest at this early stage, rather than having something disclosed further down the road."

The new reporting guidelines were introduced in the fall by the International Committee of Medical Journal Editors and are being phased in at member journals. Authors will be asked to disclose four types of information, according to an NEJM editorial:1

  • Financial associations tied to the study they worked on; 

     

  • Financial ties that could have an "interest in the general area of the submitted manuscript;" 

     

  • Similar financial associations involving spouses and children under 18 years of age; and

     

  • Relevant nonfinancial associations.
  •  

The new rules "align well with the overall trend towards transparency in healthcare," says Dr. Masica, who published this year in the Journal of Hospital Medicine. "Safety and quality data at both the hospital and practitioner level are increasingly available to the public; consistency with disclosure helps move research toward that same standard."

To that end, JHM is updating its peer-review submission Web site to incorporate the new changes and expects to make an announcement on its progress in April. "Transparency is good for healthcare delivery and establishing trust with our primary focus—the care of hospitalized patients," says Mark V. Williams, MD, FACP, FHM, JHM editor-in-chief.

Download the new ICMJE disclosure form and view completed samples.

Reference

1. Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816-823.

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