ORLANDO – Virtually no patients with type 2 diabetes and documented coronary artery disease and coronary ischemia benefit from immediate coronary revascularization, as long as they receive intensive medical management, based on the outcomes of more than 1,000 patients who were randomized to the deferred revascularization arm of the BARI 2D trial.

The only possible exception to this approach are the rare patients who initially present with severe or unstable angina and proximal left anterior descending (LAD) artery disease, a small group accounting for just 2% of these patients, Dr. Ronald J. Krone said at the annual scientific sessions of the American Heart Association. Even in this small subgroup with the worst chance of avoiding revascularization, eventual coronary bypass surgery or percutaneous coronary intervention (PCI) is not an absolute. Among the 21 patients with this initial presentation at study entry (of the total 1,192 who were randomized to the deferred revascularization arm), 50% continued to avoid revascularization 6 months later, and 29% had still not undergone revascularization 5 years after the study began, said Dr. Krone, an interventional cardiologist and professor of medicine at Washington University, St. Louis.

"What it comes down to is that there is no group you can identify up front" that unequivocally needs immediate revascularization," Dr. Krone said in an interview. "We could not identify patients who will need revascularization at a high enough rate to warrant initial revascularization, with the possible exception" of the small proximal LAD and severe angina subgroup. "Even in the worst patients, you can intervene later. We used to be afraid that if we didn’t [revascularize these patients] they would drop dead or have a big myocardial infarction, but that didn’t happen. These results give us confidence that you don’t need to intervene on every tight lesion."

Today, a physician or surgeon can’t say "’I have to revascularize, because it’s the best I can do’" for these patients. Instead, the onus is to intensively treat these patients medically, especially patients with diabetes, Dr. Krone said. This strategy includes optimal control of hypertension, lipids, glycemia, and intensive lifestyle intervention with exercise, diet, and smoking cessation.

The analysis he presented focused on patients enrolled in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes), which randomized a total of 2,368 patients with diabetes and documented coronary ischemia and stenosis suitable for an elective intervention. The researchers put all these patients on an intensive medical management regimen, and also randomized them to either immediate or deferred revascularization. The study’s primary results showed absolutely identical 5-year outcomes in the two groups, with a mortality rate of 12% in each arm of the study, and a combined rate of death, MI, or stroke of 23% in the immediate revascularization patients and 24% in those with deferred intervention (N. Engl. J. Med. 2009;360:2503-15).

Among the 1,192 patients in the deferred subgroup, 13% required PCI or bypass surgery after 6 months, and 40% needed revascularization after 5 years of follow-up. Within the group who eventually had revascularization, 47% required it for worsening angina, 23% because of an acute coronary syndrome event, 18% for worsening ischemia, 6% for progression of their coronary disease, and the remaining 6% for another reason. The current analysis aimed to determine whether "we can identify patients with such a high likelihood of needing revascularization that it need not be deferred," Dr. Krone said.

The average age of the patients in the deferred revascularization group was 62 years; 30% were women, 28% were on insulin treatment, 17% had a left ventricular ejection fraction below 50%, and 13% had proximal LAD coronary disease. Their average duration of type 2 diabetes was 11 years.

A multivariate analysis that controlled for age, sex, race, and nationality identified five factors that were linked with a significantly increased rate of revascularization after 6 months: class III or IV stable angina, unstable angina, a systolic blood pressure of 100 mm Hg or less, a blood triglyceride level of 100 mg/dL or less, and proximal LAD disease. These factors were linked with anywhere from a 3.8-fold increased rate of revascularization (in patients with systolic hypotension, compared with patients with a systolic pressure greater than 100 mm Hg) to a 75% increased rate (in patients with proximal LAD disease, compared with those without LAD disease). However, none of these increased rates appeared to justify performing routine, upfront revascularization.

The 5-year multivariate analysis produced similar results. It identified nine baseline factors that each significantly linked with a significantly increased rate of revascularization during 5-year follow-up: class I or II stable angina, class III or IV stable angina, unstable angina, systolic blood pressure of 101-120 mm Hg, a systolic pressure of 100 mm HG or less, a blood triglyceride level of 100 mg/dL or greater, proximal LAD disease, having two diseased coronary regions, or having three diseased coronary regions. The increased rates associated with these features ranged from a 90% increased revascularization rate (in patients with class III or IV stable angina, compared with patients without angina), to a 28% increased revascularization rate (in patients with class I or II stable angina at baseline). Again, none of these increased rates appeared to justify uniform, upfront revascularization, Dr. Krone said.

The sole exception to this approach might possibly be the small number of patients who initially presented with both proximal LAD disease and either class III or IV stable angina or unstable angina, because eventually over 5 years 71% of these patients underwent revascularization. But these patients constituted only 2% of the total group studied, Dr. Krone noted. In general, more severe angina or stenosis was uncommon in these patients: Some 41% had no angina and 45% had class I or II angina at baseline, and 87% were free of proximal LAD disease at baseline.

Dr. Krone said that he had no disclosures.

ORLANDO – Virtually no patients with type 2 diabetes and documented coronary artery disease and coronary ischemia benefit from immediate coronary revascularization, as long as they receive intensive medical management, based on the outcomes of more than 1,000 patients who were randomized to the deferred revascularization arm of the BARI 2D trial.

The only possible exception to this approach are the rare patients who initially present with severe or unstable angina and proximal left anterior descending (LAD) artery disease, a small group accounting for just 2% of these patients, Dr. Ronald J. Krone said at the annual scientific sessions of the American Heart Association. Even in this small subgroup with the worst chance of avoiding revascularization, eventual coronary bypass surgery or percutaneous coronary intervention (PCI) is not an absolute. Among the 21 patients with this initial presentation at study entry (of the total 1,192 who were randomized to the deferred revascularization arm), 50% continued to avoid revascularization 6 months later, and 29% had still not undergone revascularization 5 years after the study began, said Dr. Krone, an interventional cardiologist and professor of medicine at Washington University, St. Louis.

"What it comes down to is that there is no group you can identify up front" that unequivocally needs immediate revascularization," Dr. Krone said in an interview. "We could not identify patients who will need revascularization at a high enough rate to warrant initial revascularization, with the possible exception" of the small proximal LAD and severe angina subgroup. "Even in the worst patients, you can intervene later. We used to be afraid that if we didn’t [revascularize these patients] they would drop dead or have a big myocardial infarction, but that didn’t happen. These results give us confidence that you don’t need to intervene on every tight lesion."

Today, a physician or surgeon can’t say "’I have to revascularize, because it’s the best I can do’" for these patients. Instead, the onus is to intensively treat these patients medically, especially patients with diabetes, Dr. Krone said. This strategy includes optimal control of hypertension, lipids, glycemia, and intensive lifestyle intervention with exercise, diet, and smoking cessation.

The analysis he presented focused on patients enrolled in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes), which randomized a total of 2,368 patients with diabetes and documented coronary ischemia and stenosis suitable for an elective intervention. The researchers put all these patients on an intensive medical management regimen, and also randomized them to either immediate or deferred revascularization. The study’s primary results showed absolutely identical 5-year outcomes in the two groups, with a mortality rate of 12% in each arm of the study, and a combined rate of death, MI, or stroke of 23% in the immediate revascularization patients and 24% in those with deferred intervention (N. Engl. J. Med. 2009;360:2503-15).

Among the 1,192 patients in the deferred subgroup, 13% required PCI or bypass surgery after 6 months, and 40% needed revascularization after 5 years of follow-up. Within the group who eventually had revascularization, 47% required it for worsening angina, 23% because of an acute coronary syndrome event, 18% for worsening ischemia, 6% for progression of their coronary disease, and the remaining 6% for another reason. The current analysis aimed to determine whether "we can identify patients with such a high likelihood of needing revascularization that it need not be deferred," Dr. Krone said.

The average age of the patients in the deferred revascularization group was 62 years; 30% were women, 28% were on insulin treatment, 17% had a left ventricular ejection fraction below 50%, and 13% had proximal LAD coronary disease. Their average duration of type 2 diabetes was 11 years.

A multivariate analysis that controlled for age, sex, race, and nationality identified five factors that were linked with a significantly increased rate of revascularization after 6 months: class III or IV stable angina, unstable angina, a systolic blood pressure of 100 mm Hg or less, a blood triglyceride level of 100 mg/dL or less, and proximal LAD disease. These factors were linked with anywhere from a 3.8-fold increased rate of revascularization (in patients with systolic hypotension, compared with patients with a systolic pressure greater than 100 mm Hg) to a 75% increased rate (in patients with proximal LAD disease, compared with those without LAD disease). However, none of these increased rates appeared to justify performing routine, upfront revascularization.

The 5-year multivariate analysis produced similar results. It identified nine baseline factors that each significantly linked with a significantly increased rate of revascularization during 5-year follow-up: class I or II stable angina, class III or IV stable angina, unstable angina, systolic blood pressure of 101-120 mm Hg, a systolic pressure of 100 mm HG or less, a blood triglyceride level of 100 mg/dL or greater, proximal LAD disease, having two diseased coronary regions, or having three diseased coronary regions. The increased rates associated with these features ranged from a 90% increased revascularization rate (in patients with class III or IV stable angina, compared with patients without angina), to a 28% increased revascularization rate (in patients with class I or II stable angina at baseline). Again, none of these increased rates appeared to justify uniform, upfront revascularization, Dr. Krone said.

The sole exception to this approach might possibly be the small number of patients who initially presented with both proximal LAD disease and either class III or IV stable angina or unstable angina, because eventually over 5 years 71% of these patients underwent revascularization. But these patients constituted only 2% of the total group studied, Dr. Krone noted. In general, more severe angina or stenosis was uncommon in these patients: Some 41% had no angina and 45% had class I or II angina at baseline, and 87% were free of proximal LAD disease at baseline.

Dr. Krone said that he had no disclosures.

ORLANDO – Virtually no patients with type 2 diabetes and documented coronary artery disease and coronary ischemia benefit from immediate coronary revascularization, as long as they receive intensive medical management, based on the outcomes of more than 1,000 patients who were randomized to the deferred revascularization arm of the BARI 2D trial.

The only possible exception to this approach are the rare patients who initially present with severe or unstable angina and proximal left anterior descending (LAD) artery disease, a small group accounting for just 2% of these patients, Dr. Ronald J. Krone said at the annual scientific sessions of the American Heart Association. Even in this small subgroup with the worst chance of avoiding revascularization, eventual coronary bypass surgery or percutaneous coronary intervention (PCI) is not an absolute. Among the 21 patients with this initial presentation at study entry (of the total 1,192 who were randomized to the deferred revascularization arm), 50% continued to avoid revascularization 6 months later, and 29% had still not undergone revascularization 5 years after the study began, said Dr. Krone, an interventional cardiologist and professor of medicine at Washington University, St. Louis.

"What it comes down to is that there is no group you can identify up front" that unequivocally needs immediate revascularization," Dr. Krone said in an interview. "We could not identify patients who will need revascularization at a high enough rate to warrant initial revascularization, with the possible exception" of the small proximal LAD and severe angina subgroup. "Even in the worst patients, you can intervene later. We used to be afraid that if we didn’t [revascularize these patients] they would drop dead or have a big myocardial infarction, but that didn’t happen. These results give us confidence that you don’t need to intervene on every tight lesion."

Today, a physician or surgeon can’t say "’I have to revascularize, because it’s the best I can do’" for these patients. Instead, the onus is to intensively treat these patients medically, especially patients with diabetes, Dr. Krone said. This strategy includes optimal control of hypertension, lipids, glycemia, and intensive lifestyle intervention with exercise, diet, and smoking cessation.

The analysis he presented focused on patients enrolled in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes), which randomized a total of 2,368 patients with diabetes and documented coronary ischemia and stenosis suitable for an elective intervention. The researchers put all these patients on an intensive medical management regimen, and also randomized them to either immediate or deferred revascularization. The study’s primary results showed absolutely identical 5-year outcomes in the two groups, with a mortality rate of 12% in each arm of the study, and a combined rate of death, MI, or stroke of 23% in the immediate revascularization patients and 24% in those with deferred intervention (N. Engl. J. Med. 2009;360:2503-15).

Among the 1,192 patients in the deferred subgroup, 13% required PCI or bypass surgery after 6 months, and 40% needed revascularization after 5 years of follow-up. Within the group who eventually had revascularization, 47% required it for worsening angina, 23% because of an acute coronary syndrome event, 18% for worsening ischemia, 6% for progression of their coronary disease, and the remaining 6% for another reason. The current analysis aimed to determine whether "we can identify patients with such a high likelihood of needing revascularization that it need not be deferred," Dr. Krone said.

The average age of the patients in the deferred revascularization group was 62 years; 30% were women, 28% were on insulin treatment, 17% had a left ventricular ejection fraction below 50%, and 13% had proximal LAD coronary disease. Their average duration of type 2 diabetes was 11 years.

A multivariate analysis that controlled for age, sex, race, and nationality identified five factors that were linked with a significantly increased rate of revascularization after 6 months: class III or IV stable angina, unstable angina, a systolic blood pressure of 100 mm Hg or less, a blood triglyceride level of 100 mg/dL or less, and proximal LAD disease. These factors were linked with anywhere from a 3.8-fold increased rate of revascularization (in patients with systolic hypotension, compared with patients with a systolic pressure greater than 100 mm Hg) to a 75% increased rate (in patients with proximal LAD disease, compared with those without LAD disease). However, none of these increased rates appeared to justify performing routine, upfront revascularization.

The 5-year multivariate analysis produced similar results. It identified nine baseline factors that each significantly linked with a significantly increased rate of revascularization during 5-year follow-up: class I or II stable angina, class III or IV stable angina, unstable angina, systolic blood pressure of 101-120 mm Hg, a systolic pressure of 100 mm HG or less, a blood triglyceride level of 100 mg/dL or greater, proximal LAD disease, having two diseased coronary regions, or having three diseased coronary regions. The increased rates associated with these features ranged from a 90% increased revascularization rate (in patients with class III or IV stable angina, compared with patients without angina), to a 28% increased revascularization rate (in patients with class I or II stable angina at baseline). Again, none of these increased rates appeared to justify uniform, upfront revascularization, Dr. Krone said.

The sole exception to this approach might possibly be the small number of patients who initially presented with both proximal LAD disease and either class III or IV stable angina or unstable angina, because eventually over 5 years 71% of these patients underwent revascularization. But these patients constituted only 2% of the total group studied, Dr. Krone noted. In general, more severe angina or stenosis was uncommon in these patients: Some 41% had no angina and 45% had class I or II angina at baseline, and 87% were free of proximal LAD disease at baseline.

Dr. Krone said that he had no disclosures.

In a much-anticipated double milestone, the Food and Drug Administration has approved ruxolitinib for treatment of patients with myelofibrosis.

Ruxolitinib, an orphan drug to be marketed as Jakafi by Incyte Corp., becomes the first agent to be approved for the rare blood disease. The indication covers patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF, according to a statement from Wilmington, Del.–based Incyte.

The FDA decision also makes ruxolitinib the first approved agent in a new class of drugs called JAK (Janus-associated kinase) inhibitors. Deregulation of signaling in the JAK pathway is believed to be associated with the enlarged spleen and other symptoms of myelofibrosis. Ruxolitinib inhibits the tyrosine kinases JAK1 and JAK2, which are suspected of being up-regulated in various inflammatory disorders and malignancies.

"Jakafi represents another example of an increasing trend in oncology where a detailed scientific understanding of the mechanisms of a disease allows a drug to be directed toward specific molecular pathways," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

"The clinical trials leading to this approval focused on problems that patients with myelofibrosis commonly encounter, including enlarged spleens and pain," he noted.

In the pivotal phase III COMFORT-I and COMFORT-II trials, ruxolitinib produced substantial symptom relief in patients who were resistant or refractory to available myelofibrosis therapy or ineligible for allogeneic bone marrow transplantation. All 528 patients in these studies had enlarged spleens (splenomegaly) and other disease-related symptoms. They were assigned to treatment with ruxolitinib, placebo, or best available therapy (usually hydroxyurea or glucocorticoids).

More patients on ruxolitinib had a greater-than-35% reduction in spleen size, compared with those given the alternatives, the FDA noted. Similarly, patients on ruxolitinib were more likely to have a more-than-50% reduction in MF-related symptoms, such as abdominal discomfort, night sweats, itching, and bone or muscle pain, compared with placebo.

The Incyte announcement noted that 41.9% of patients who were treated with ruxolitinib in the COMFORT-I trial had a 35% or greater reduction in spleen volume at 24 weeks, compared with 0.7% of patients taking placebo (P less than 0.0001). The median time to response was less than 4 weeks.

In the COMFORT-II trial, 28.5% of patients who were treated with ruxolitinib had a 35% or greater reduction in spleen volume at 48 weeks, compared with none of the patients in the best available therapy arm, Incyte said. COMFORT-II was conducted by Novartis, which is collaborating with Incyte outside the United States.

Incyte said that the ruxolitinib dosage should be adjusted based on safety and efficacy. The recommended starting dose of ruxolitinib for most patients of 15 mg or 20 mg given orally twice daily based on the patient’s platelet count. A blood cell count must be performed before initiation of therapy, the company said, and complete blood counts should be monitored every 2-4 weeks until doses are stabilized.

Thrombocytopenia, anemia, fatigue, diarrhea, dyspnea, headache, dizziness, and nausea were the most common side effects, according to the FDA.

In a much-anticipated double milestone, the Food and Drug Administration has approved ruxolitinib for treatment of patients with myelofibrosis.

Ruxolitinib, an orphan drug to be marketed as Jakafi by Incyte Corp., becomes the first agent to be approved for the rare blood disease. The indication covers patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF, according to a statement from Wilmington, Del.–based Incyte.

The FDA decision also makes ruxolitinib the first approved agent in a new class of drugs called JAK (Janus-associated kinase) inhibitors. Deregulation of signaling in the JAK pathway is believed to be associated with the enlarged spleen and other symptoms of myelofibrosis. Ruxolitinib inhibits the tyrosine kinases JAK1 and JAK2, which are suspected of being up-regulated in various inflammatory disorders and malignancies.

"Jakafi represents another example of an increasing trend in oncology where a detailed scientific understanding of the mechanisms of a disease allows a drug to be directed toward specific molecular pathways," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

"The clinical trials leading to this approval focused on problems that patients with myelofibrosis commonly encounter, including enlarged spleens and pain," he noted.

In the pivotal phase III COMFORT-I and COMFORT-II trials, ruxolitinib produced substantial symptom relief in patients who were resistant or refractory to available myelofibrosis therapy or ineligible for allogeneic bone marrow transplantation. All 528 patients in these studies had enlarged spleens (splenomegaly) and other disease-related symptoms. They were assigned to treatment with ruxolitinib, placebo, or best available therapy (usually hydroxyurea or glucocorticoids).

More patients on ruxolitinib had a greater-than-35% reduction in spleen size, compared with those given the alternatives, the FDA noted. Similarly, patients on ruxolitinib were more likely to have a more-than-50% reduction in MF-related symptoms, such as abdominal discomfort, night sweats, itching, and bone or muscle pain, compared with placebo.

The Incyte announcement noted that 41.9% of patients who were treated with ruxolitinib in the COMFORT-I trial had a 35% or greater reduction in spleen volume at 24 weeks, compared with 0.7% of patients taking placebo (P less than 0.0001). The median time to response was less than 4 weeks.

In the COMFORT-II trial, 28.5% of patients who were treated with ruxolitinib had a 35% or greater reduction in spleen volume at 48 weeks, compared with none of the patients in the best available therapy arm, Incyte said. COMFORT-II was conducted by Novartis, which is collaborating with Incyte outside the United States.

Incyte said that the ruxolitinib dosage should be adjusted based on safety and efficacy. The recommended starting dose of ruxolitinib for most patients of 15 mg or 20 mg given orally twice daily based on the patient’s platelet count. A blood cell count must be performed before initiation of therapy, the company said, and complete blood counts should be monitored every 2-4 weeks until doses are stabilized.

Thrombocytopenia, anemia, fatigue, diarrhea, dyspnea, headache, dizziness, and nausea were the most common side effects, according to the FDA.

In a much-anticipated double milestone, the Food and Drug Administration has approved ruxolitinib for treatment of patients with myelofibrosis.

Ruxolitinib, an orphan drug to be marketed as Jakafi by Incyte Corp., becomes the first agent to be approved for the rare blood disease. The indication covers patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF, according to a statement from Wilmington, Del.–based Incyte.

The FDA decision also makes ruxolitinib the first approved agent in a new class of drugs called JAK (Janus-associated kinase) inhibitors. Deregulation of signaling in the JAK pathway is believed to be associated with the enlarged spleen and other symptoms of myelofibrosis. Ruxolitinib inhibits the tyrosine kinases JAK1 and JAK2, which are suspected of being up-regulated in various inflammatory disorders and malignancies.

"Jakafi represents another example of an increasing trend in oncology where a detailed scientific understanding of the mechanisms of a disease allows a drug to be directed toward specific molecular pathways," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

"The clinical trials leading to this approval focused on problems that patients with myelofibrosis commonly encounter, including enlarged spleens and pain," he noted.

In the pivotal phase III COMFORT-I and COMFORT-II trials, ruxolitinib produced substantial symptom relief in patients who were resistant or refractory to available myelofibrosis therapy or ineligible for allogeneic bone marrow transplantation. All 528 patients in these studies had enlarged spleens (splenomegaly) and other disease-related symptoms. They were assigned to treatment with ruxolitinib, placebo, or best available therapy (usually hydroxyurea or glucocorticoids).

More patients on ruxolitinib had a greater-than-35% reduction in spleen size, compared with those given the alternatives, the FDA noted. Similarly, patients on ruxolitinib were more likely to have a more-than-50% reduction in MF-related symptoms, such as abdominal discomfort, night sweats, itching, and bone or muscle pain, compared with placebo.

The Incyte announcement noted that 41.9% of patients who were treated with ruxolitinib in the COMFORT-I trial had a 35% or greater reduction in spleen volume at 24 weeks, compared with 0.7% of patients taking placebo (P less than 0.0001). The median time to response was less than 4 weeks.

In the COMFORT-II trial, 28.5% of patients who were treated with ruxolitinib had a 35% or greater reduction in spleen volume at 48 weeks, compared with none of the patients in the best available therapy arm, Incyte said. COMFORT-II was conducted by Novartis, which is collaborating with Incyte outside the United States.

Incyte said that the ruxolitinib dosage should be adjusted based on safety and efficacy. The recommended starting dose of ruxolitinib for most patients of 15 mg or 20 mg given orally twice daily based on the patient’s platelet count. A blood cell count must be performed before initiation of therapy, the company said, and complete blood counts should be monitored every 2-4 weeks until doses are stabilized.

Thrombocytopenia, anemia, fatigue, diarrhea, dyspnea, headache, dizziness, and nausea were the most common side effects, according to the FDA.

Modesty comes naturally to IPC The Hospitalist Co. executive Dave Bowman, MD. He shies from the spotlight and seeks to downplay his own accomplishments in favor of talking about the results of those he works with.

That tack got a bit more difficult last month when Dr. Bowman, based in Tucson, Ariz., received the Medical Group Management Association (MGMA) and American College of Medical Practice Executives' (ACMPE) "Physician Executive of the Year" award for 2011. It's the second year in a row the honor went to an HM leader; last year's winner was IPC chief executive Adam Singer, MD.

Dr. Bowman was praised both for his professional skills and the heroic role he played providing medical aid in the immediate aftermath of the Jan. 8 shooting in Tucson that left six people dead and injured 13 others, including U.S. Rep. Gabrielle Giffords (D-Ariz.)

Dr. Bowman tried to downplay the award until it was presented at a conference last month in Las Vegas. "When I step back and look at it from a non-physician-jaundiced view, that was a pretty neat thing. I was very humbled and grateful," he says.

He quickly adds, though, that the award means those he works with are doing their jobs just as exceptionally.

"You have to have a team to take care of people," he says. "If you're a lone wolf, you can do a good job for your 16 patients that day. But what happens when you leave? ... You have to be part of a team to ensure the good work you’re doing is continued."

Dr. Bowman, IPC's executive director in Tucson, has grown his group's practice to more than 75 physicians and non-physician providers. He notes that all of his providers with at least one year of seniority sit on at least one committee at their institution.

But his most sage advice for hospitalist leaders?

"Get involved, be out there," he says. "Take night call because you have two letters after your name that says you can do it. ... Be involved clinically, not just administratively."

Modesty comes naturally to IPC The Hospitalist Co. executive Dave Bowman, MD. He shies from the spotlight and seeks to downplay his own accomplishments in favor of talking about the results of those he works with.

That tack got a bit more difficult last month when Dr. Bowman, based in Tucson, Ariz., received the Medical Group Management Association (MGMA) and American College of Medical Practice Executives' (ACMPE) "Physician Executive of the Year" award for 2011. It's the second year in a row the honor went to an HM leader; last year's winner was IPC chief executive Adam Singer, MD.

Dr. Bowman was praised both for his professional skills and the heroic role he played providing medical aid in the immediate aftermath of the Jan. 8 shooting in Tucson that left six people dead and injured 13 others, including U.S. Rep. Gabrielle Giffords (D-Ariz.)

Dr. Bowman tried to downplay the award until it was presented at a conference last month in Las Vegas. "When I step back and look at it from a non-physician-jaundiced view, that was a pretty neat thing. I was very humbled and grateful," he says.

He quickly adds, though, that the award means those he works with are doing their jobs just as exceptionally.

"You have to have a team to take care of people," he says. "If you're a lone wolf, you can do a good job for your 16 patients that day. But what happens when you leave? ... You have to be part of a team to ensure the good work you’re doing is continued."

Dr. Bowman, IPC's executive director in Tucson, has grown his group's practice to more than 75 physicians and non-physician providers. He notes that all of his providers with at least one year of seniority sit on at least one committee at their institution.

But his most sage advice for hospitalist leaders?

"Get involved, be out there," he says. "Take night call because you have two letters after your name that says you can do it. ... Be involved clinically, not just administratively."

Modesty comes naturally to IPC The Hospitalist Co. executive Dave Bowman, MD. He shies from the spotlight and seeks to downplay his own accomplishments in favor of talking about the results of those he works with.

That tack got a bit more difficult last month when Dr. Bowman, based in Tucson, Ariz., received the Medical Group Management Association (MGMA) and American College of Medical Practice Executives' (ACMPE) "Physician Executive of the Year" award for 2011. It's the second year in a row the honor went to an HM leader; last year's winner was IPC chief executive Adam Singer, MD.

Dr. Bowman was praised both for his professional skills and the heroic role he played providing medical aid in the immediate aftermath of the Jan. 8 shooting in Tucson that left six people dead and injured 13 others, including U.S. Rep. Gabrielle Giffords (D-Ariz.)

Dr. Bowman tried to downplay the award until it was presented at a conference last month in Las Vegas. "When I step back and look at it from a non-physician-jaundiced view, that was a pretty neat thing. I was very humbled and grateful," he says.

He quickly adds, though, that the award means those he works with are doing their jobs just as exceptionally.

"You have to have a team to take care of people," he says. "If you're a lone wolf, you can do a good job for your 16 patients that day. But what happens when you leave? ... You have to be part of a team to ensure the good work you’re doing is continued."

Dr. Bowman, IPC's executive director in Tucson, has grown his group's practice to more than 75 physicians and non-physician providers. He notes that all of his providers with at least one year of seniority sit on at least one committee at their institution.

But his most sage advice for hospitalist leaders?

"Get involved, be out there," he says. "Take night call because you have two letters after your name that says you can do it. ... Be involved clinically, not just administratively."

Clinical question: Which clinical decision rule—Wells rule, simplified Wells rule, revised Geneva score, or simplified revised Geneva score—is the best for evaluating a patient with a possible acute pulmonary embolism?

Background: The use of standardized clinical decision rules to determine the probability of an acute pulmonary embolism (PE) has significantly improved the diagnostic evaluation of patients with suspected PE. Several clinical decision rules are available and widely used, but they have not been previously directly compared.

Study design: Prospective cohort.

Setting: Seven hospitals in the Netherlands.

Synopsis: A total of 807 patients with suspected first episode of acute PE had a sequential workup with clinical probability assessment and D-dimer testing. When PE was considered unlikely according to all four clinical decision rules and a normal D-dimer result, PE was excluded. In the remaining patients, a CT scan was used to confirm or exclude the diagnosis.

The prevalence of PE was 23%. Combined with a normal D-dimer, the decision rules excluded PE in 22% to 24% of patients. Thirty percent of patients had discordant decision rule outcomes, but PE was not detected by CT in any of these patients when combined with a normal D-dimer.

This study has practical limitations because management was based on a combination of four decision rules and D-dimer testing rather than only one rule and D-dimer testing, which is the more realistic clinical approach.

Bottom line: When used correctly and in conjunction with a D-dimer result, the Wells rule, simplified Wells rule, revised Geneva score, and simplified revised Geneva score all perform similarly in the exclusion of acute PE.

Citation: Douma RA, Mos IC, Erkens PM, et al. Performance of 4 clinical decision rules in the diagnostic management of acute pulmonary embolism: a prospective cohort study. Ann Intern Med. 2011;154:709-718.

For more of physician reviews of HM-related literature, check out this month's"In the Literature".

Clinical question: Which clinical decision rule—Wells rule, simplified Wells rule, revised Geneva score, or simplified revised Geneva score—is the best for evaluating a patient with a possible acute pulmonary embolism?

Background: The use of standardized clinical decision rules to determine the probability of an acute pulmonary embolism (PE) has significantly improved the diagnostic evaluation of patients with suspected PE. Several clinical decision rules are available and widely used, but they have not been previously directly compared.

Study design: Prospective cohort.

Setting: Seven hospitals in the Netherlands.

Synopsis: A total of 807 patients with suspected first episode of acute PE had a sequential workup with clinical probability assessment and D-dimer testing. When PE was considered unlikely according to all four clinical decision rules and a normal D-dimer result, PE was excluded. In the remaining patients, a CT scan was used to confirm or exclude the diagnosis.

The prevalence of PE was 23%. Combined with a normal D-dimer, the decision rules excluded PE in 22% to 24% of patients. Thirty percent of patients had discordant decision rule outcomes, but PE was not detected by CT in any of these patients when combined with a normal D-dimer.

This study has practical limitations because management was based on a combination of four decision rules and D-dimer testing rather than only one rule and D-dimer testing, which is the more realistic clinical approach.

Bottom line: When used correctly and in conjunction with a D-dimer result, the Wells rule, simplified Wells rule, revised Geneva score, and simplified revised Geneva score all perform similarly in the exclusion of acute PE.

Citation: Douma RA, Mos IC, Erkens PM, et al. Performance of 4 clinical decision rules in the diagnostic management of acute pulmonary embolism: a prospective cohort study. Ann Intern Med. 2011;154:709-718.

For more of physician reviews of HM-related literature, check out this month's"In the Literature".

Clinical question: Which clinical decision rule—Wells rule, simplified Wells rule, revised Geneva score, or simplified revised Geneva score—is the best for evaluating a patient with a possible acute pulmonary embolism?

Background: The use of standardized clinical decision rules to determine the probability of an acute pulmonary embolism (PE) has significantly improved the diagnostic evaluation of patients with suspected PE. Several clinical decision rules are available and widely used, but they have not been previously directly compared.

Study design: Prospective cohort.

Setting: Seven hospitals in the Netherlands.

Synopsis: A total of 807 patients with suspected first episode of acute PE had a sequential workup with clinical probability assessment and D-dimer testing. When PE was considered unlikely according to all four clinical decision rules and a normal D-dimer result, PE was excluded. In the remaining patients, a CT scan was used to confirm or exclude the diagnosis.

The prevalence of PE was 23%. Combined with a normal D-dimer, the decision rules excluded PE in 22% to 24% of patients. Thirty percent of patients had discordant decision rule outcomes, but PE was not detected by CT in any of these patients when combined with a normal D-dimer.

This study has practical limitations because management was based on a combination of four decision rules and D-dimer testing rather than only one rule and D-dimer testing, which is the more realistic clinical approach.

Bottom line: When used correctly and in conjunction with a D-dimer result, the Wells rule, simplified Wells rule, revised Geneva score, and simplified revised Geneva score all perform similarly in the exclusion of acute PE.

Citation: Douma RA, Mos IC, Erkens PM, et al. Performance of 4 clinical decision rules in the diagnostic management of acute pulmonary embolism: a prospective cohort study. Ann Intern Med. 2011;154:709-718.

For more of physician reviews of HM-related literature, check out this month's"In the Literature".

ORLANDO – Obese patients coached solely over the phone and Internet lost as much weight as did those counseled in person, according to the findings of a prospective, randomized controlled trial.

Moreover, both groups maintained their weight loss during the 2-year follow-up period of the POWER (Practice-Based Opportunities for Weight Reduction) trial.

At 24 months, 38% of patients in the remote group had lost at least 5% of their initial body weight vs. 41% of the in-person group and just 19% in a control group whose weight-loss was self-directed, Dr. Lawrence J. Appel said at the annual scientific sessions of the American Heart Association.

At 24 months, the mean weight loss was –4.6 kg or 10.1 pounds in the remote group vs. –5.1 kg or 11.2 pounds in the in-person group (P = .63), and –0.8 kg or 1.7 pounds in the control group.

At no point in the study did the weight loss in the two active treatment arms differ, said Dr. Appel, professor of medicine and director of the Welch Center for Prevention, Epidemiology and Clinical Research at Johns Hopkins University in Baltimore.

The sustained weight loss observed in POWER is unprecedented. "It could be considered something of a breakthrough in weight loss," Dr. Frank Sacks, professor of cardiovascular disease prevention at Harvard School of Public Health in Boston, observed at a press briefing. Dr. Sacks was an invited discussant for the paper.

Session moderator Dr. Donald Lloyd-Jones, chair of preventive medicine at Northwestern University, Chicago, called POWER an incredibly important trial given that obesity is by far the No. 1 public health problem in the United States and will drive cardiovascular disease in the coming decades.

"This is absolutely a game changer," he said in an interview. "To see a scalable, very inexpensive therapy, that can be done at arm’s length without too much [intensity] from the provider side, and yet fully engage patients in the process of their weight loss is a very exciting development."

The trial enrolled 415 obese patients with at least one cardiovascular risk factor and a mean weight of 103 kg and mean body mass index of 37 kg/m².

Patients assigned to the remote group had to enter their weight on the study website before being guided to other educational modules on physical exercise and calorie counting. They could also view their weight-loss goal and progress, Dr. Appel explained.

Physicians reviewed the weight progress reports and played a supportive role through tailored e-mails. Counseling was provided by telephone by employees of Healthways, a disease management promotion company, with no face-to-face contact.

The website and physician’s roles were similar in the in-person group, but these patients received counseling in group meetings, individual meetings, and via telephone from employees of Johns Hopkins.

All patients were encouraged to reduce caloric intake, follow the DASH diet, exercise at least 180 min/week and to log in to the study website at least weekly.

During the first 6 months, the remote group took part in a median of 14 of the 15 recommended phone contacts with their coach and a median of 16 of 18 recommended phone calls over the next 18 months.

The experience in the in-person group was remarkably different, Dr. Appel said. Patients took part in just 6.5 of the 12 recommended group sessions in the first 6 months and only 1 of 18 sessions over the next 18 months, with attendance at individual sessions following a similar pattern. Ultimately, the program "morphed" into a phone intervention, likely because of the convenience and flexibility the format offers, he said. The in-person group maintained 3 of 4 recommended phone contacts with their coaches in the first 6 months and 11 of 12 contacts over the next 18 months.

The study website engaged the patients, with the remote group making 23 of the 26 recommended log ins during the first six months and the in-person group making 20.5 of the 26 log-ins, Dr. Appel said. Over the next 18 months both groups logged in to the website 35 of the 72 recommended times, and visited their primary care provider just once.

During a panel discussion, Dr. Darwin Labarthe, a professor of preventive medicine at Northwestern, said the results are probably the strongest evidence to date on the ability of adults to reduce weight on a sustained basis, but suggested that further follow-up is needed postintervention. He also asked whether the degree of weight loss observed in POWER had an impact on cardiovascular risk factors.

Dr. Appel said the trial was not set up to look at these outcomes, however evidence from other studies suggests that in a prediabetic population, a 5% loss in body weight will reduce the incidence of diabetes by 40%-50%. A reduction in systolic blood pressure also can be expected. Although patients were on medications for this, there was a relationship between systolic blood pressure reduction and weight loss across the entire study population, he said.

At baseline, 76% of patients had hypertension, 68% hypercholesterolemia, 23% diabetes, and 33% metabolic syndrome. Their mean age was 54 years, 64% were women, 56% were white and 41% were black.

The cost of such a remote program depends on how it is rolled out, but that the coaching staff was the biggest driver of expenses at about $600-$800 for the 2 years, Dr. Appel noted. Johns Hopkins is working on implementing the remote intervention and Healthways is expected to make the program commercially available, he said in an interview.

The remote intervention, consisting of phone counseling, an interactive website, and physician support, "has the potential for widespread implementation and should be applicable to the management of other chronic conditions," he told the attendees.

The trial was funded by the National Heart, Lung, and Blood Institute, with data analytic support provided by the National Institute of Diabetes and Digestive and Kidney Disease. Dr. Appel reported no conflicts of interest.

ORLANDO – Obese patients coached solely over the phone and Internet lost as much weight as did those counseled in person, according to the findings of a prospective, randomized controlled trial.

Moreover, both groups maintained their weight loss during the 2-year follow-up period of the POWER (Practice-Based Opportunities for Weight Reduction) trial.

At 24 months, 38% of patients in the remote group had lost at least 5% of their initial body weight vs. 41% of the in-person group and just 19% in a control group whose weight-loss was self-directed, Dr. Lawrence J. Appel said at the annual scientific sessions of the American Heart Association.

At 24 months, the mean weight loss was –4.6 kg or 10.1 pounds in the remote group vs. –5.1 kg or 11.2 pounds in the in-person group (P = .63), and –0.8 kg or 1.7 pounds in the control group.

At no point in the study did the weight loss in the two active treatment arms differ, said Dr. Appel, professor of medicine and director of the Welch Center for Prevention, Epidemiology and Clinical Research at Johns Hopkins University in Baltimore.

The sustained weight loss observed in POWER is unprecedented. "It could be considered something of a breakthrough in weight loss," Dr. Frank Sacks, professor of cardiovascular disease prevention at Harvard School of Public Health in Boston, observed at a press briefing. Dr. Sacks was an invited discussant for the paper.

Session moderator Dr. Donald Lloyd-Jones, chair of preventive medicine at Northwestern University, Chicago, called POWER an incredibly important trial given that obesity is by far the No. 1 public health problem in the United States and will drive cardiovascular disease in the coming decades.

"This is absolutely a game changer," he said in an interview. "To see a scalable, very inexpensive therapy, that can be done at arm’s length without too much [intensity] from the provider side, and yet fully engage patients in the process of their weight loss is a very exciting development."

The trial enrolled 415 obese patients with at least one cardiovascular risk factor and a mean weight of 103 kg and mean body mass index of 37 kg/m².

Patients assigned to the remote group had to enter their weight on the study website before being guided to other educational modules on physical exercise and calorie counting. They could also view their weight-loss goal and progress, Dr. Appel explained.

Physicians reviewed the weight progress reports and played a supportive role through tailored e-mails. Counseling was provided by telephone by employees of Healthways, a disease management promotion company, with no face-to-face contact.

The website and physician’s roles were similar in the in-person group, but these patients received counseling in group meetings, individual meetings, and via telephone from employees of Johns Hopkins.

All patients were encouraged to reduce caloric intake, follow the DASH diet, exercise at least 180 min/week and to log in to the study website at least weekly.

During the first 6 months, the remote group took part in a median of 14 of the 15 recommended phone contacts with their coach and a median of 16 of 18 recommended phone calls over the next 18 months.

The experience in the in-person group was remarkably different, Dr. Appel said. Patients took part in just 6.5 of the 12 recommended group sessions in the first 6 months and only 1 of 18 sessions over the next 18 months, with attendance at individual sessions following a similar pattern. Ultimately, the program "morphed" into a phone intervention, likely because of the convenience and flexibility the format offers, he said. The in-person group maintained 3 of 4 recommended phone contacts with their coaches in the first 6 months and 11 of 12 contacts over the next 18 months.

The study website engaged the patients, with the remote group making 23 of the 26 recommended log ins during the first six months and the in-person group making 20.5 of the 26 log-ins, Dr. Appel said. Over the next 18 months both groups logged in to the website 35 of the 72 recommended times, and visited their primary care provider just once.

During a panel discussion, Dr. Darwin Labarthe, a professor of preventive medicine at Northwestern, said the results are probably the strongest evidence to date on the ability of adults to reduce weight on a sustained basis, but suggested that further follow-up is needed postintervention. He also asked whether the degree of weight loss observed in POWER had an impact on cardiovascular risk factors.

Dr. Appel said the trial was not set up to look at these outcomes, however evidence from other studies suggests that in a prediabetic population, a 5% loss in body weight will reduce the incidence of diabetes by 40%-50%. A reduction in systolic blood pressure also can be expected. Although patients were on medications for this, there was a relationship between systolic blood pressure reduction and weight loss across the entire study population, he said.

At baseline, 76% of patients had hypertension, 68% hypercholesterolemia, 23% diabetes, and 33% metabolic syndrome. Their mean age was 54 years, 64% were women, 56% were white and 41% were black.

The cost of such a remote program depends on how it is rolled out, but that the coaching staff was the biggest driver of expenses at about $600-$800 for the 2 years, Dr. Appel noted. Johns Hopkins is working on implementing the remote intervention and Healthways is expected to make the program commercially available, he said in an interview.

The remote intervention, consisting of phone counseling, an interactive website, and physician support, "has the potential for widespread implementation and should be applicable to the management of other chronic conditions," he told the attendees.

The trial was funded by the National Heart, Lung, and Blood Institute, with data analytic support provided by the National Institute of Diabetes and Digestive and Kidney Disease. Dr. Appel reported no conflicts of interest.

ORLANDO – Obese patients coached solely over the phone and Internet lost as much weight as did those counseled in person, according to the findings of a prospective, randomized controlled trial.

Moreover, both groups maintained their weight loss during the 2-year follow-up period of the POWER (Practice-Based Opportunities for Weight Reduction) trial.

At 24 months, 38% of patients in the remote group had lost at least 5% of their initial body weight vs. 41% of the in-person group and just 19% in a control group whose weight-loss was self-directed, Dr. Lawrence J. Appel said at the annual scientific sessions of the American Heart Association.

At 24 months, the mean weight loss was –4.6 kg or 10.1 pounds in the remote group vs. –5.1 kg or 11.2 pounds in the in-person group (P = .63), and –0.8 kg or 1.7 pounds in the control group.

At no point in the study did the weight loss in the two active treatment arms differ, said Dr. Appel, professor of medicine and director of the Welch Center for Prevention, Epidemiology and Clinical Research at Johns Hopkins University in Baltimore.

The sustained weight loss observed in POWER is unprecedented. "It could be considered something of a breakthrough in weight loss," Dr. Frank Sacks, professor of cardiovascular disease prevention at Harvard School of Public Health in Boston, observed at a press briefing. Dr. Sacks was an invited discussant for the paper.

Session moderator Dr. Donald Lloyd-Jones, chair of preventive medicine at Northwestern University, Chicago, called POWER an incredibly important trial given that obesity is by far the No. 1 public health problem in the United States and will drive cardiovascular disease in the coming decades.

"This is absolutely a game changer," he said in an interview. "To see a scalable, very inexpensive therapy, that can be done at arm’s length without too much [intensity] from the provider side, and yet fully engage patients in the process of their weight loss is a very exciting development."

The trial enrolled 415 obese patients with at least one cardiovascular risk factor and a mean weight of 103 kg and mean body mass index of 37 kg/m².

Patients assigned to the remote group had to enter their weight on the study website before being guided to other educational modules on physical exercise and calorie counting. They could also view their weight-loss goal and progress, Dr. Appel explained.

Physicians reviewed the weight progress reports and played a supportive role through tailored e-mails. Counseling was provided by telephone by employees of Healthways, a disease management promotion company, with no face-to-face contact.

The website and physician’s roles were similar in the in-person group, but these patients received counseling in group meetings, individual meetings, and via telephone from employees of Johns Hopkins.

All patients were encouraged to reduce caloric intake, follow the DASH diet, exercise at least 180 min/week and to log in to the study website at least weekly.

During the first 6 months, the remote group took part in a median of 14 of the 15 recommended phone contacts with their coach and a median of 16 of 18 recommended phone calls over the next 18 months.

The experience in the in-person group was remarkably different, Dr. Appel said. Patients took part in just 6.5 of the 12 recommended group sessions in the first 6 months and only 1 of 18 sessions over the next 18 months, with attendance at individual sessions following a similar pattern. Ultimately, the program "morphed" into a phone intervention, likely because of the convenience and flexibility the format offers, he said. The in-person group maintained 3 of 4 recommended phone contacts with their coaches in the first 6 months and 11 of 12 contacts over the next 18 months.

The study website engaged the patients, with the remote group making 23 of the 26 recommended log ins during the first six months and the in-person group making 20.5 of the 26 log-ins, Dr. Appel said. Over the next 18 months both groups logged in to the website 35 of the 72 recommended times, and visited their primary care provider just once.

During a panel discussion, Dr. Darwin Labarthe, a professor of preventive medicine at Northwestern, said the results are probably the strongest evidence to date on the ability of adults to reduce weight on a sustained basis, but suggested that further follow-up is needed postintervention. He also asked whether the degree of weight loss observed in POWER had an impact on cardiovascular risk factors.

Dr. Appel said the trial was not set up to look at these outcomes, however evidence from other studies suggests that in a prediabetic population, a 5% loss in body weight will reduce the incidence of diabetes by 40%-50%. A reduction in systolic blood pressure also can be expected. Although patients were on medications for this, there was a relationship between systolic blood pressure reduction and weight loss across the entire study population, he said.

At baseline, 76% of patients had hypertension, 68% hypercholesterolemia, 23% diabetes, and 33% metabolic syndrome. Their mean age was 54 years, 64% were women, 56% were white and 41% were black.

The cost of such a remote program depends on how it is rolled out, but that the coaching staff was the biggest driver of expenses at about $600-$800 for the 2 years, Dr. Appel noted. Johns Hopkins is working on implementing the remote intervention and Healthways is expected to make the program commercially available, he said in an interview.

The remote intervention, consisting of phone counseling, an interactive website, and physician support, "has the potential for widespread implementation and should be applicable to the management of other chronic conditions," he told the attendees.

The trial was funded by the National Heart, Lung, and Blood Institute, with data analytic support provided by the National Institute of Diabetes and Digestive and Kidney Disease. Dr. Appel reported no conflicts of interest.

Perhaps the best news about the cholesterol testing now recommended for all children aged 9-11 years by an expert panel convened by the National Heart, Lung, and Blood Institute is that children don’t have to fast before getting their blood drawn. The guidelines were published online on Nov. 13 and appear in the December issue of Pediatrics.

Dr. Stephen R. Daniels, chair of the expert panel that reviewed the guidelines, emphasized that the new approach to cholesterol screening can be accomplished with a blood test that does not require fasting, so it should be relatively easy to include in a busy practice. This strategy "ensures that children with elevated LDL (or bad) cholesterol will be identified."

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Daniels, pediatrician-in-chief at the University of Colorado at Denver, Aurora.

Data from previous studies have shown that atherosclerosis begins in youth, and that heart attacks, strokes, and other cardiovascular problems in adulthood are often the end result of cardiovascular risk factors that went unrecognized throughout childhood, according to the report (Pediatrics 2011 Nov. 13 [doi:10.1542/peds.2009-2107C]).

The current guidelines represent the latest update since the 1990s, said Dr. Daniels.

"These guidelines are different in that they are based on a comprehensive and systematic review of the literature, they are integrated across all risk factors (hypertension, dyslipidemia, obesity, diabetes, and cigarette smoking) and lifestyle factors (diet and physical activity), and they address issues across the pediatric age range," he said in an interview.

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Stephen R. Daniels.

The "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents Summary Report" provides details for how to reduce risk factors and help prevent cardiovascular problems in children from birth to 21 years of age, starting with a recommendation for exclusive breastfeeding of children for the first 6 months of life.

However, the most notable new element in the guidelines is universal cholesterol-screening recommendation for preadolescents.

According to the guidelines, doctors should obtain a universal lipid screen with nonfasting non-HDL cholesterol (that is, total cholesterol minus HDL cholesterol) or a fasting lipid profile (FLP) for all children at least once between the ages of 9 and 11 years, and "manage per lipid algorithms as needed." Diet and exercise are recommended as first-line treatment, but statins may be considered in children whose high cholesterol persists despite diet and lifestyle interventions.

The guidelines recommend obtaining an FLP at age 12-17 years if a child’s family history is newly positive, if a parent has dyslipidemia, or if the child has any other risk factors or high-risk conditions, and then managing per lipid algorithms as needed.

For all patients aged 18-21 years, the guidelines recommend measuring one nonfasting non-HDL or FLP, and then reviewing the results with patients and managing them with lipid algorithms per Adult Treatment Panel III as needed.

Preventive steps to reduce risk and prevent cardiovascular disease in all ages include regular physical activity, with vigorous activity 3 days a week, according to the "Physical Activity Guidelines Advisory Committee Report 2008" from the Department of Health and Human Services.

Other preventive measures include a diet low in saturated fat for all children starting at 1 year of age, as well as both practice- and school-based interventions to keep children from smoking and to help them quit.

The guidelines also recommend annual blood pressure measurement for all children starting at 3 years of age, and interpreted for age, sex, and height. The report has a chart with an algorithm and flow diagram to assist clinicians in diagnosing hypertension in children.

"The rationale for these guidelines is that there is more and more evidence for the concept that atherosclerosis begins in childhood and depends on the same risk factors we are concerned about in adults," Dr. Daniels said. "This means that we should try to prevent these risk factors from developing in the first place (primordial prevention) and identify children at higher risk, so we can work on improving their lifestyle," he added.

"Cardiovascular disease is the most common cause of death for both men and women. So, this places great importance on these issues for primary care pediatricians. The new approach to screening may actually be easier to implement than the old strategy, which requires constant updating of the family history," noted Dr. Daniels, who is also chairman and professor of pediatrics at the university.

"This test should be done once for every child in the 9- to 11-year age range. The universal approach to screening will identify children with a genetic cause for their high cholesterol (1 in 500 children) and children with cholesterol abnormalities based more on lifestyle," said Dr. Daniels. "Both groups will benefit from lifestyle intervention, which can be useful in lowering their lifetime risk of cardiovascular disease."

Dr. Daniels has served as a consultant for Abbott Laboratories, Merck, and Schering-Plough, and has received funding/grant support for research from the National Institutes of Health. Other members of the committee that reviewed the guidelines disclosed research support from various agencies and pharmaceutical companies.

Perhaps the best news about the cholesterol testing now recommended for all children aged 9-11 years by an expert panel convened by the National Heart, Lung, and Blood Institute is that children don’t have to fast before getting their blood drawn. The guidelines were published online on Nov. 13 and appear in the December issue of Pediatrics.

Dr. Stephen R. Daniels, chair of the expert panel that reviewed the guidelines, emphasized that the new approach to cholesterol screening can be accomplished with a blood test that does not require fasting, so it should be relatively easy to include in a busy practice. This strategy "ensures that children with elevated LDL (or bad) cholesterol will be identified."

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Daniels, pediatrician-in-chief at the University of Colorado at Denver, Aurora.

Data from previous studies have shown that atherosclerosis begins in youth, and that heart attacks, strokes, and other cardiovascular problems in adulthood are often the end result of cardiovascular risk factors that went unrecognized throughout childhood, according to the report (Pediatrics 2011 Nov. 13 [doi:10.1542/peds.2009-2107C]).

The current guidelines represent the latest update since the 1990s, said Dr. Daniels.

"These guidelines are different in that they are based on a comprehensive and systematic review of the literature, they are integrated across all risk factors (hypertension, dyslipidemia, obesity, diabetes, and cigarette smoking) and lifestyle factors (diet and physical activity), and they address issues across the pediatric age range," he said in an interview.

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Stephen R. Daniels.

The "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents Summary Report" provides details for how to reduce risk factors and help prevent cardiovascular problems in children from birth to 21 years of age, starting with a recommendation for exclusive breastfeeding of children for the first 6 months of life.

However, the most notable new element in the guidelines is universal cholesterol-screening recommendation for preadolescents.

According to the guidelines, doctors should obtain a universal lipid screen with nonfasting non-HDL cholesterol (that is, total cholesterol minus HDL cholesterol) or a fasting lipid profile (FLP) for all children at least once between the ages of 9 and 11 years, and "manage per lipid algorithms as needed." Diet and exercise are recommended as first-line treatment, but statins may be considered in children whose high cholesterol persists despite diet and lifestyle interventions.

The guidelines recommend obtaining an FLP at age 12-17 years if a child’s family history is newly positive, if a parent has dyslipidemia, or if the child has any other risk factors or high-risk conditions, and then managing per lipid algorithms as needed.

For all patients aged 18-21 years, the guidelines recommend measuring one nonfasting non-HDL or FLP, and then reviewing the results with patients and managing them with lipid algorithms per Adult Treatment Panel III as needed.

Preventive steps to reduce risk and prevent cardiovascular disease in all ages include regular physical activity, with vigorous activity 3 days a week, according to the "Physical Activity Guidelines Advisory Committee Report 2008" from the Department of Health and Human Services.

Other preventive measures include a diet low in saturated fat for all children starting at 1 year of age, as well as both practice- and school-based interventions to keep children from smoking and to help them quit.

The guidelines also recommend annual blood pressure measurement for all children starting at 3 years of age, and interpreted for age, sex, and height. The report has a chart with an algorithm and flow diagram to assist clinicians in diagnosing hypertension in children.

"The rationale for these guidelines is that there is more and more evidence for the concept that atherosclerosis begins in childhood and depends on the same risk factors we are concerned about in adults," Dr. Daniels said. "This means that we should try to prevent these risk factors from developing in the first place (primordial prevention) and identify children at higher risk, so we can work on improving their lifestyle," he added.

"Cardiovascular disease is the most common cause of death for both men and women. So, this places great importance on these issues for primary care pediatricians. The new approach to screening may actually be easier to implement than the old strategy, which requires constant updating of the family history," noted Dr. Daniels, who is also chairman and professor of pediatrics at the university.

"This test should be done once for every child in the 9- to 11-year age range. The universal approach to screening will identify children with a genetic cause for their high cholesterol (1 in 500 children) and children with cholesterol abnormalities based more on lifestyle," said Dr. Daniels. "Both groups will benefit from lifestyle intervention, which can be useful in lowering their lifetime risk of cardiovascular disease."

Dr. Daniels has served as a consultant for Abbott Laboratories, Merck, and Schering-Plough, and has received funding/grant support for research from the National Institutes of Health. Other members of the committee that reviewed the guidelines disclosed research support from various agencies and pharmaceutical companies.

Perhaps the best news about the cholesterol testing now recommended for all children aged 9-11 years by an expert panel convened by the National Heart, Lung, and Blood Institute is that children don’t have to fast before getting their blood drawn. The guidelines were published online on Nov. 13 and appear in the December issue of Pediatrics.

Dr. Stephen R. Daniels, chair of the expert panel that reviewed the guidelines, emphasized that the new approach to cholesterol screening can be accomplished with a blood test that does not require fasting, so it should be relatively easy to include in a busy practice. This strategy "ensures that children with elevated LDL (or bad) cholesterol will be identified."

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Daniels, pediatrician-in-chief at the University of Colorado at Denver, Aurora.

Data from previous studies have shown that atherosclerosis begins in youth, and that heart attacks, strokes, and other cardiovascular problems in adulthood are often the end result of cardiovascular risk factors that went unrecognized throughout childhood, according to the report (Pediatrics 2011 Nov. 13 [doi:10.1542/peds.2009-2107C]).

The current guidelines represent the latest update since the 1990s, said Dr. Daniels.

"These guidelines are different in that they are based on a comprehensive and systematic review of the literature, they are integrated across all risk factors (hypertension, dyslipidemia, obesity, diabetes, and cigarette smoking) and lifestyle factors (diet and physical activity), and they address issues across the pediatric age range," he said in an interview.

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Stephen R. Daniels.

The "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents Summary Report" provides details for how to reduce risk factors and help prevent cardiovascular problems in children from birth to 21 years of age, starting with a recommendation for exclusive breastfeeding of children for the first 6 months of life.

However, the most notable new element in the guidelines is universal cholesterol-screening recommendation for preadolescents.

According to the guidelines, doctors should obtain a universal lipid screen with nonfasting non-HDL cholesterol (that is, total cholesterol minus HDL cholesterol) or a fasting lipid profile (FLP) for all children at least once between the ages of 9 and 11 years, and "manage per lipid algorithms as needed." Diet and exercise are recommended as first-line treatment, but statins may be considered in children whose high cholesterol persists despite diet and lifestyle interventions.

The guidelines recommend obtaining an FLP at age 12-17 years if a child’s family history is newly positive, if a parent has dyslipidemia, or if the child has any other risk factors or high-risk conditions, and then managing per lipid algorithms as needed.

For all patients aged 18-21 years, the guidelines recommend measuring one nonfasting non-HDL or FLP, and then reviewing the results with patients and managing them with lipid algorithms per Adult Treatment Panel III as needed.

Preventive steps to reduce risk and prevent cardiovascular disease in all ages include regular physical activity, with vigorous activity 3 days a week, according to the "Physical Activity Guidelines Advisory Committee Report 2008" from the Department of Health and Human Services.

Other preventive measures include a diet low in saturated fat for all children starting at 1 year of age, as well as both practice- and school-based interventions to keep children from smoking and to help them quit.

The guidelines also recommend annual blood pressure measurement for all children starting at 3 years of age, and interpreted for age, sex, and height. The report has a chart with an algorithm and flow diagram to assist clinicians in diagnosing hypertension in children.

"The rationale for these guidelines is that there is more and more evidence for the concept that atherosclerosis begins in childhood and depends on the same risk factors we are concerned about in adults," Dr. Daniels said. "This means that we should try to prevent these risk factors from developing in the first place (primordial prevention) and identify children at higher risk, so we can work on improving their lifestyle," he added.

"Cardiovascular disease is the most common cause of death for both men and women. So, this places great importance on these issues for primary care pediatricians. The new approach to screening may actually be easier to implement than the old strategy, which requires constant updating of the family history," noted Dr. Daniels, who is also chairman and professor of pediatrics at the university.

"This test should be done once for every child in the 9- to 11-year age range. The universal approach to screening will identify children with a genetic cause for their high cholesterol (1 in 500 children) and children with cholesterol abnormalities based more on lifestyle," said Dr. Daniels. "Both groups will benefit from lifestyle intervention, which can be useful in lowering their lifetime risk of cardiovascular disease."

Dr. Daniels has served as a consultant for Abbott Laboratories, Merck, and Schering-Plough, and has received funding/grant support for research from the National Institutes of Health. Other members of the committee that reviewed the guidelines disclosed research support from various agencies and pharmaceutical companies.