Patrice Wendling

CHICAGO — A computerized pretest probability device accurately predicted acute coronary syndrome in low-risk patients who present with chest pain, and significantly reduced exposure to thoracic imaging and return visits to the emergency department in a randomized, controlled trial in 400 patients.

The Web-based software device (PRETestConsultACS) produces a point estimate of pretest probability of acute coronary syndrome (ACS) based on eight predictor variables: age; sex; race; history of coronary artery disease; chest wall tenderness to palpation that reproduces chest pain; diaphoresis; ST depression greater than 0.5 mm in two leads; and T-wave inversion greater than 0.5 mm in two leads.

The variables are then entered into a personal computer or personal digital assistant that searches a large, stored database of previously evaluated patients for those who share the same profile of eight variables. The percentage of matched patients from the database who have ACS equals the pretest probability.

ACS included myocardial infarction; coronary stenosis greater than 60% prompting new medical management or revascularization; ventricular arrhythmia; cardiogenic shock; or bradycardia requiring therapeutic intervention.

After obtaining a clinician's estimate of pretest probability of an ACS, 400 patients (mean age, 46 years) and their emergency clinicians were randomized to receive a written printout from the computer, or not. In all, 31 patients were excluded because of cocaine use or because they left the study.

Pretest probability estimates of an ACS generated by the emergency clinician (mean, 4) correlated significantly with the estimates from the computerized device (mean, 4), according to a poster presentation at the annual meeting of the American College of Emergency Physicians.

A significant cardiovascular diagnosis was made in 36 (19.4%) of the 185 patients in the control group and 35 (19%) of the 184 patients in the intervention group.

Researchers discovered only one case of a missed or delayed diagnosis of ACS within 45 days, the study's primary safety end point, and that was in a patient who was assigned to the control group, lead investigator Dr. Jeffrey Kline and colleagues in the department of emergency medicine, Carolinas Medical Center, Charlotte, N.C., reported. The patient was diagnosed with unstable angina that was treated with a percutaneous intracoronary stent device 21 days after enrollment.

The rate of hospital admission of patients who had no significant cardiovascular diagnosis within 45 days was significantly higher in the control group (11%) than in the intervention group (5%).

The rate of exposure to a thoracic imaging test that imparted greater than 5 mSv and had a negative result was significantly greater among controls (19.4%) than patients in the intervention group (8.6%), the investigators reported. The lifetime risk of malignancy is thought to increase significantly after a dose of radiation that exceeds 5 mSv.

“If the results of this study are independently validated in a larger and different sample of patients, then clinicians will have evidence to justify the use of quantitative pretest probability, together with their own clinical instincts, to reduce excessive diagnostic testing in low-risk patients with chest pain,” Dr. Kline said in an interview.

Median length of stay in the emergency department was not significantly different between the control (11.4 hours) and intervention (9.2 hours) groups.

Significantly more patients in the intervention group reported being “very satisfied” with the clinical explanation of their problem, compared with those in the control group (49% vs. 38%).

Based on telephone follow-up, patients in the intervention group were less likely than those in the control group to be readmitted within 7 days of their emergency visit (4% vs. 11%), according to the investigators, who reported no relevant conflicts of interest.

CHICAGO — A computerized pretest probability device accurately predicted acute coronary syndrome in low-risk patients who present with chest pain, and significantly reduced exposure to thoracic imaging and return visits to the emergency department in a randomized, controlled trial in 400 patients.

The Web-based software device (PRETestConsultACS) produces a point estimate of pretest probability of acute coronary syndrome (ACS) based on eight predictor variables: age; sex; race; history of coronary artery disease; chest wall tenderness to palpation that reproduces chest pain; diaphoresis; ST depression greater than 0.5 mm in two leads; and T-wave inversion greater than 0.5 mm in two leads.

The variables are then entered into a personal computer or personal digital assistant that searches a large, stored database of previously evaluated patients for those who share the same profile of eight variables. The percentage of matched patients from the database who have ACS equals the pretest probability.

ACS included myocardial infarction; coronary stenosis greater than 60% prompting new medical management or revascularization; ventricular arrhythmia; cardiogenic shock; or bradycardia requiring therapeutic intervention.

After obtaining a clinician's estimate of pretest probability of an ACS, 400 patients (mean age, 46 years) and their emergency clinicians were randomized to receive a written printout from the computer, or not. In all, 31 patients were excluded because of cocaine use or because they left the study.

Pretest probability estimates of an ACS generated by the emergency clinician (mean, 4) correlated significantly with the estimates from the computerized device (mean, 4), according to a poster presentation at the annual meeting of the American College of Emergency Physicians.

A significant cardiovascular diagnosis was made in 36 (19.4%) of the 185 patients in the control group and 35 (19%) of the 184 patients in the intervention group.

Researchers discovered only one case of a missed or delayed diagnosis of ACS within 45 days, the study's primary safety end point, and that was in a patient who was assigned to the control group, lead investigator Dr. Jeffrey Kline and colleagues in the department of emergency medicine, Carolinas Medical Center, Charlotte, N.C., reported. The patient was diagnosed with unstable angina that was treated with a percutaneous intracoronary stent device 21 days after enrollment.

The rate of hospital admission of patients who had no significant cardiovascular diagnosis within 45 days was significantly higher in the control group (11%) than in the intervention group (5%).

The rate of exposure to a thoracic imaging test that imparted greater than 5 mSv and had a negative result was significantly greater among controls (19.4%) than patients in the intervention group (8.6%), the investigators reported. The lifetime risk of malignancy is thought to increase significantly after a dose of radiation that exceeds 5 mSv.

“If the results of this study are independently validated in a larger and different sample of patients, then clinicians will have evidence to justify the use of quantitative pretest probability, together with their own clinical instincts, to reduce excessive diagnostic testing in low-risk patients with chest pain,” Dr. Kline said in an interview.

Median length of stay in the emergency department was not significantly different between the control (11.4 hours) and intervention (9.2 hours) groups.

Significantly more patients in the intervention group reported being “very satisfied” with the clinical explanation of their problem, compared with those in the control group (49% vs. 38%).

Based on telephone follow-up, patients in the intervention group were less likely than those in the control group to be readmitted within 7 days of their emergency visit (4% vs. 11%), according to the investigators, who reported no relevant conflicts of interest.

CHICAGO — A computerized pretest probability device accurately predicted acute coronary syndrome in low-risk patients who present with chest pain, and significantly reduced exposure to thoracic imaging and return visits to the emergency department in a randomized, controlled trial in 400 patients.

The Web-based software device (PRETestConsultACS) produces a point estimate of pretest probability of acute coronary syndrome (ACS) based on eight predictor variables: age; sex; race; history of coronary artery disease; chest wall tenderness to palpation that reproduces chest pain; diaphoresis; ST depression greater than 0.5 mm in two leads; and T-wave inversion greater than 0.5 mm in two leads.

The variables are then entered into a personal computer or personal digital assistant that searches a large, stored database of previously evaluated patients for those who share the same profile of eight variables. The percentage of matched patients from the database who have ACS equals the pretest probability.

ACS included myocardial infarction; coronary stenosis greater than 60% prompting new medical management or revascularization; ventricular arrhythmia; cardiogenic shock; or bradycardia requiring therapeutic intervention.

After obtaining a clinician's estimate of pretest probability of an ACS, 400 patients (mean age, 46 years) and their emergency clinicians were randomized to receive a written printout from the computer, or not. In all, 31 patients were excluded because of cocaine use or because they left the study.

Pretest probability estimates of an ACS generated by the emergency clinician (mean, 4) correlated significantly with the estimates from the computerized device (mean, 4), according to a poster presentation at the annual meeting of the American College of Emergency Physicians.

A significant cardiovascular diagnosis was made in 36 (19.4%) of the 185 patients in the control group and 35 (19%) of the 184 patients in the intervention group.

Researchers discovered only one case of a missed or delayed diagnosis of ACS within 45 days, the study's primary safety end point, and that was in a patient who was assigned to the control group, lead investigator Dr. Jeffrey Kline and colleagues in the department of emergency medicine, Carolinas Medical Center, Charlotte, N.C., reported. The patient was diagnosed with unstable angina that was treated with a percutaneous intracoronary stent device 21 days after enrollment.

The rate of hospital admission of patients who had no significant cardiovascular diagnosis within 45 days was significantly higher in the control group (11%) than in the intervention group (5%).

The rate of exposure to a thoracic imaging test that imparted greater than 5 mSv and had a negative result was significantly greater among controls (19.4%) than patients in the intervention group (8.6%), the investigators reported. The lifetime risk of malignancy is thought to increase significantly after a dose of radiation that exceeds 5 mSv.

“If the results of this study are independently validated in a larger and different sample of patients, then clinicians will have evidence to justify the use of quantitative pretest probability, together with their own clinical instincts, to reduce excessive diagnostic testing in low-risk patients with chest pain,” Dr. Kline said in an interview.

Median length of stay in the emergency department was not significantly different between the control (11.4 hours) and intervention (9.2 hours) groups.

Significantly more patients in the intervention group reported being “very satisfied” with the clinical explanation of their problem, compared with those in the control group (49% vs. 38%).

Based on telephone follow-up, patients in the intervention group were less likely than those in the control group to be readmitted within 7 days of their emergency visit (4% vs. 11%), according to the investigators, who reported no relevant conflicts of interest.

CHICAGO — The diagnosis and treatment of attention-deficit/hyperactivity disorder in preschoolers are tricky, although there is evidence to support the use of stimulants in their treatment, Dr. Alison Schonwald said.

Diagnosing children as young as 3 and 4 years is difficult in part because ADHD symptoms at this age mimic many other conditions such as anxiety and depression, hearing or vision problems, learning or cognitive deficits, and lead exposure. Children whose parents have serious mental health issues also can look disorganized, inattentive, and impulsive. The same is true for children who've been traumatized. “I've personally never seen a kid who's living in a shelter who didn't look like they had ADHD,” said Dr. Schonwald of Harvard Medical School in Boston.

The other issue is simple variation in normal development. Children start to develop the ability to inhibit their behavior at 3 years, while at 4 years most children can voluntarily direct their attention to uninteresting tasks. Not all children, however, follow the same developmental trajectory, with differences in temperament and sex also playing into the equation.

“I do often find a difference between girls and boys,” Dr. Schonwald said at a meeting sponsored by the American Academy of Pediatrics. “There are some 4-year-old girls who can sit for 2 hours and happily color. Not a lot of 4-year-old boys can do that.”

A diagnosis of ADHD in a preschooler is rarely made based on history, observation, and teacher rating scales alone, but only after a full evaluation that includes cognitive and language testing, the pediatrician explained.

Treatment begins with parent training and environmental modifications to help the child function better and to ensure his or her safety. Structured preschool with an experienced teacher also is recommended. Medication is used only when behavioral interventions are ineffective or when the child is exhibiting dangerous behaviors.

Evidence to support stimulant use in preschoolers comes from the Preschool ADHD Treatment Study, in which 2.5 mg, 5 mg, and 7.5 mg methylphenidate three times a day resulted in a significant decrease in ADHD symptoms in 165 children, aged 3–5.5 years (J. Am. Acad. Child Adolesc. Psychiatry 2006;45:1284–93). The mean optimal total daily dosage was 14.2 mg/day.

The categorical criterion for remission, however, was met in only 21% of children on their best dose and in 13% on placebo, suggesting that the magnitude of improvement with methylphenidate is going to be lower in preschoolers, Dr. Schonwald said.

“I think that for typical kids in elementary school or older with ADHD, you can treat 90% of them with an ADHD medication that is effective and well tolerated, but you're not going to get such good numbers with preschoolers,” she said.

Moderate to severe adverse events were reported in 30% of children, chiefly decreased appetite, trouble sleeping, and weight loss. But aggression and increased blood pressure also were reported. In addition, annual growth rates were 20% less than expected for height (−1.38 cm/yr) and 55% less for weight (−1.32 kg/yr).

Although there was no signal of cardiac irregularities in the study, cardiac monitoring is now a consideration when using ADHD drugs in children. Concerns about the risk of sudden cardiac death associated with stimulant use in children prompted the American Heart Association to issue a statement in April 2008 recommending cardiac risk screening and ECGs routinely in children before the start of ADHD medications (Circulation 2008; 117:2407–23), although the recommendation for routine use of ECGs later was withdrawn.

The recommendations caused a stir in the pediatric community, with the AAP responding with a policy statement of its own containing a cardiac evaluation algorithm (Pediatrics 2008;122:451–3). It recommended that “clinicians carefully assess all children for cardiac abnormalities, including those in whom ADHD treatment is being considered, by using history and physical assessment,” but against “the routine use of ECGs before initiating stimulant therapy for ADHD.”

Dr. Schonwald said she performs an ECG only in patients with a concerning personal history or suggestive family history. Dr. Schonwald disclosed that she is on the speakers bureau for Ortho-McNeil Pharmaceutical Inc. and previously has spoken for Novartis.

CHICAGO — The diagnosis and treatment of attention-deficit/hyperactivity disorder in preschoolers are tricky, although there is evidence to support the use of stimulants in their treatment, Dr. Alison Schonwald said.

Diagnosing children as young as 3 and 4 years is difficult in part because ADHD symptoms at this age mimic many other conditions such as anxiety and depression, hearing or vision problems, learning or cognitive deficits, and lead exposure. Children whose parents have serious mental health issues also can look disorganized, inattentive, and impulsive. The same is true for children who've been traumatized. “I've personally never seen a kid who's living in a shelter who didn't look like they had ADHD,” said Dr. Schonwald of Harvard Medical School in Boston.

The other issue is simple variation in normal development. Children start to develop the ability to inhibit their behavior at 3 years, while at 4 years most children can voluntarily direct their attention to uninteresting tasks. Not all children, however, follow the same developmental trajectory, with differences in temperament and sex also playing into the equation.

“I do often find a difference between girls and boys,” Dr. Schonwald said at a meeting sponsored by the American Academy of Pediatrics. “There are some 4-year-old girls who can sit for 2 hours and happily color. Not a lot of 4-year-old boys can do that.”

A diagnosis of ADHD in a preschooler is rarely made based on history, observation, and teacher rating scales alone, but only after a full evaluation that includes cognitive and language testing, the pediatrician explained.

Treatment begins with parent training and environmental modifications to help the child function better and to ensure his or her safety. Structured preschool with an experienced teacher also is recommended. Medication is used only when behavioral interventions are ineffective or when the child is exhibiting dangerous behaviors.

Evidence to support stimulant use in preschoolers comes from the Preschool ADHD Treatment Study, in which 2.5 mg, 5 mg, and 7.5 mg methylphenidate three times a day resulted in a significant decrease in ADHD symptoms in 165 children, aged 3–5.5 years (J. Am. Acad. Child Adolesc. Psychiatry 2006;45:1284–93). The mean optimal total daily dosage was 14.2 mg/day.

The categorical criterion for remission, however, was met in only 21% of children on their best dose and in 13% on placebo, suggesting that the magnitude of improvement with methylphenidate is going to be lower in preschoolers, Dr. Schonwald said.

“I think that for typical kids in elementary school or older with ADHD, you can treat 90% of them with an ADHD medication that is effective and well tolerated, but you're not going to get such good numbers with preschoolers,” she said.

Moderate to severe adverse events were reported in 30% of children, chiefly decreased appetite, trouble sleeping, and weight loss. But aggression and increased blood pressure also were reported. In addition, annual growth rates were 20% less than expected for height (−1.38 cm/yr) and 55% less for weight (−1.32 kg/yr).

Although there was no signal of cardiac irregularities in the study, cardiac monitoring is now a consideration when using ADHD drugs in children. Concerns about the risk of sudden cardiac death associated with stimulant use in children prompted the American Heart Association to issue a statement in April 2008 recommending cardiac risk screening and ECGs routinely in children before the start of ADHD medications (Circulation 2008; 117:2407–23), although the recommendation for routine use of ECGs later was withdrawn.

The recommendations caused a stir in the pediatric community, with the AAP responding with a policy statement of its own containing a cardiac evaluation algorithm (Pediatrics 2008;122:451–3). It recommended that “clinicians carefully assess all children for cardiac abnormalities, including those in whom ADHD treatment is being considered, by using history and physical assessment,” but against “the routine use of ECGs before initiating stimulant therapy for ADHD.”

Dr. Schonwald said she performs an ECG only in patients with a concerning personal history or suggestive family history. Dr. Schonwald disclosed that she is on the speakers bureau for Ortho-McNeil Pharmaceutical Inc. and previously has spoken for Novartis.

CHICAGO — The diagnosis and treatment of attention-deficit/hyperactivity disorder in preschoolers are tricky, although there is evidence to support the use of stimulants in their treatment, Dr. Alison Schonwald said.

Diagnosing children as young as 3 and 4 years is difficult in part because ADHD symptoms at this age mimic many other conditions such as anxiety and depression, hearing or vision problems, learning or cognitive deficits, and lead exposure. Children whose parents have serious mental health issues also can look disorganized, inattentive, and impulsive. The same is true for children who've been traumatized. “I've personally never seen a kid who's living in a shelter who didn't look like they had ADHD,” said Dr. Schonwald of Harvard Medical School in Boston.

The other issue is simple variation in normal development. Children start to develop the ability to inhibit their behavior at 3 years, while at 4 years most children can voluntarily direct their attention to uninteresting tasks. Not all children, however, follow the same developmental trajectory, with differences in temperament and sex also playing into the equation.

“I do often find a difference between girls and boys,” Dr. Schonwald said at a meeting sponsored by the American Academy of Pediatrics. “There are some 4-year-old girls who can sit for 2 hours and happily color. Not a lot of 4-year-old boys can do that.”

A diagnosis of ADHD in a preschooler is rarely made based on history, observation, and teacher rating scales alone, but only after a full evaluation that includes cognitive and language testing, the pediatrician explained.

Treatment begins with parent training and environmental modifications to help the child function better and to ensure his or her safety. Structured preschool with an experienced teacher also is recommended. Medication is used only when behavioral interventions are ineffective or when the child is exhibiting dangerous behaviors.

Evidence to support stimulant use in preschoolers comes from the Preschool ADHD Treatment Study, in which 2.5 mg, 5 mg, and 7.5 mg methylphenidate three times a day resulted in a significant decrease in ADHD symptoms in 165 children, aged 3–5.5 years (J. Am. Acad. Child Adolesc. Psychiatry 2006;45:1284–93). The mean optimal total daily dosage was 14.2 mg/day.

The categorical criterion for remission, however, was met in only 21% of children on their best dose and in 13% on placebo, suggesting that the magnitude of improvement with methylphenidate is going to be lower in preschoolers, Dr. Schonwald said.

“I think that for typical kids in elementary school or older with ADHD, you can treat 90% of them with an ADHD medication that is effective and well tolerated, but you're not going to get such good numbers with preschoolers,” she said.

Moderate to severe adverse events were reported in 30% of children, chiefly decreased appetite, trouble sleeping, and weight loss. But aggression and increased blood pressure also were reported. In addition, annual growth rates were 20% less than expected for height (−1.38 cm/yr) and 55% less for weight (−1.32 kg/yr).

Although there was no signal of cardiac irregularities in the study, cardiac monitoring is now a consideration when using ADHD drugs in children. Concerns about the risk of sudden cardiac death associated with stimulant use in children prompted the American Heart Association to issue a statement in April 2008 recommending cardiac risk screening and ECGs routinely in children before the start of ADHD medications (Circulation 2008; 117:2407–23), although the recommendation for routine use of ECGs later was withdrawn.

The recommendations caused a stir in the pediatric community, with the AAP responding with a policy statement of its own containing a cardiac evaluation algorithm (Pediatrics 2008;122:451–3). It recommended that “clinicians carefully assess all children for cardiac abnormalities, including those in whom ADHD treatment is being considered, by using history and physical assessment,” but against “the routine use of ECGs before initiating stimulant therapy for ADHD.”

Dr. Schonwald said she performs an ECG only in patients with a concerning personal history or suggestive family history. Dr. Schonwald disclosed that she is on the speakers bureau for Ortho-McNeil Pharmaceutical Inc. and previously has spoken for Novartis.

CHICAGO – The efficacy of deep brain stimulation can be maintained for up to 10 years in DYT1 dystonia, according to data from a study in 26 consecutive patients.

This prospective study is the first to report on more than 3 years of follow-up of deep brain stimulation (DBS) in DYT1 dystonia–a form of primary dystonia that typically presents in early childhood and is caused by a mutation in the DYT1 gene.

Significant decreases in Burke-Fahn-Marsden dystonia rating scale motor and disability scores were observed 1 year after DBS surgery. No significant difference was found when the 1-year scores were compared with the scores at 3, 5, and 6 years for the whole population, Dr. Laura Cif and associates reported in a poster at the 12th International Congress of Parkinson's Disease and Movement Disorders.

Efficacy of DBS therapy was maintained in the two patients who were followed as long as 10 years.

Long-term disease progression is even more important in DYTI dystonia than in other disorders treated with DBS, such as Parkinson's disease, because patients are much younger at the time of surgery and therefore require significantly longer-term follow-up, according to Dr. Cif of the University of Montpellier (France). The age at onset ranged from 6 to 20 years in the study. Moreover, DYT1 dystonia can develop into a life-threatening condition.

Eighteen patients were implanted with a single pair of electrodes in the internal globus pallidus (GPi) and eight patients had a second pair of GPi electrodes implanted because of incomplete initial response or subsequent worsening.

In spite of there being no significant difference 1 year after surgery, a significant difference was observed at 5 years between patients with a single lead vs. those with double leads in motor (8.95 vs. 31.5) and disability (3.61 vs. 7.85) scores. After implantation of additional pairs of leads, only four of the eight patients showed subsequent improvement.

During the follow-up, no patient died, including several patients with status dystonicus, who usually are not expected to survive for more than a few weeks, Dr. Cif said in an interview.

CHICAGO – The efficacy of deep brain stimulation can be maintained for up to 10 years in DYT1 dystonia, according to data from a study in 26 consecutive patients.

This prospective study is the first to report on more than 3 years of follow-up of deep brain stimulation (DBS) in DYT1 dystonia–a form of primary dystonia that typically presents in early childhood and is caused by a mutation in the DYT1 gene.

Significant decreases in Burke-Fahn-Marsden dystonia rating scale motor and disability scores were observed 1 year after DBS surgery. No significant difference was found when the 1-year scores were compared with the scores at 3, 5, and 6 years for the whole population, Dr. Laura Cif and associates reported in a poster at the 12th International Congress of Parkinson's Disease and Movement Disorders.

Efficacy of DBS therapy was maintained in the two patients who were followed as long as 10 years.

Long-term disease progression is even more important in DYTI dystonia than in other disorders treated with DBS, such as Parkinson's disease, because patients are much younger at the time of surgery and therefore require significantly longer-term follow-up, according to Dr. Cif of the University of Montpellier (France). The age at onset ranged from 6 to 20 years in the study. Moreover, DYT1 dystonia can develop into a life-threatening condition.

Eighteen patients were implanted with a single pair of electrodes in the internal globus pallidus (GPi) and eight patients had a second pair of GPi electrodes implanted because of incomplete initial response or subsequent worsening.

In spite of there being no significant difference 1 year after surgery, a significant difference was observed at 5 years between patients with a single lead vs. those with double leads in motor (8.95 vs. 31.5) and disability (3.61 vs. 7.85) scores. After implantation of additional pairs of leads, only four of the eight patients showed subsequent improvement.

During the follow-up, no patient died, including several patients with status dystonicus, who usually are not expected to survive for more than a few weeks, Dr. Cif said in an interview.

CHICAGO – The efficacy of deep brain stimulation can be maintained for up to 10 years in DYT1 dystonia, according to data from a study in 26 consecutive patients.

This prospective study is the first to report on more than 3 years of follow-up of deep brain stimulation (DBS) in DYT1 dystonia–a form of primary dystonia that typically presents in early childhood and is caused by a mutation in the DYT1 gene.

Significant decreases in Burke-Fahn-Marsden dystonia rating scale motor and disability scores were observed 1 year after DBS surgery. No significant difference was found when the 1-year scores were compared with the scores at 3, 5, and 6 years for the whole population, Dr. Laura Cif and associates reported in a poster at the 12th International Congress of Parkinson's Disease and Movement Disorders.

Efficacy of DBS therapy was maintained in the two patients who were followed as long as 10 years.

Long-term disease progression is even more important in DYTI dystonia than in other disorders treated with DBS, such as Parkinson's disease, because patients are much younger at the time of surgery and therefore require significantly longer-term follow-up, according to Dr. Cif of the University of Montpellier (France). The age at onset ranged from 6 to 20 years in the study. Moreover, DYT1 dystonia can develop into a life-threatening condition.

Eighteen patients were implanted with a single pair of electrodes in the internal globus pallidus (GPi) and eight patients had a second pair of GPi electrodes implanted because of incomplete initial response or subsequent worsening.

In spite of there being no significant difference 1 year after surgery, a significant difference was observed at 5 years between patients with a single lead vs. those with double leads in motor (8.95 vs. 31.5) and disability (3.61 vs. 7.85) scores. After implantation of additional pairs of leads, only four of the eight patients showed subsequent improvement.

During the follow-up, no patient died, including several patients with status dystonicus, who usually are not expected to survive for more than a few weeks, Dr. Cif said in an interview.

CHICAGO—Medicaid cutbacks in Tennessee were associated with an abrupt and sustained increase in emergency department use and hospital admission among the uninsured, research shows.

In August 2005, the state of Tennessee disenrolled approximately 171,000 individuals older than 18 years from TennCare, the state's Medicaid managed care program.

Between the predisenrollment period of Jan. 1, 2004, through July 31, 2005, and the postdisenrollment period of Aug. 1, 2005, through July 31, 2006, ED visits by the uninsured increased by 95,464, or 4.5%, and decreased among TennCare beneficiaries by 160,823, or 6%.

“This research shows that health policy decisions have real effects on the patients we see in America's emergency departments,” said Dr. Benjamin S. Heavrin, who presented the study findings at the annual meeting of the American College of Emergency Physicians. “The cost savings from disenrollment resulted in an increasing proportion of uninsured patients in Tennessee's EDs. This suggests an increasing financial burden on the newly uninsured and a possible ominous shift in their health status, based on our admission data.”

The uninsured represented 12.7% of all patients in the EDs in the predisenrollment period, compared with 17.2% in the postdisenrollment period, Dr. Heavrin and his associates reported.

The largest weekly correlation (−0.95) between ED visits among the uninsured and TennCare beneficiaries corresponded exactly to the time when disenrollment began.

When ED use was calculated by calendar year, the incidence of ED visits among the uninsured increased by a relative 34.5%, from 44 visits per 100 persons per year in 2004 to 59.2 visits per 100 persons per year in 2006.

Total ED visits in the state decreased by 74,178 during the study period, which is predictable given a Medicaid population's use of the ED, according to Dr. Heavrin, chief resident, department of emergency medicine, Vanderbilt University Medical Center in Nashville, Tenn. A recent study showed that Medicaid enrollees visited the ED about three times more often than the uninsured (Med. Care 2008;46:1099–107).

An evaluation of admission data by Dr. Heavrin and his associates revealed that the admission rate of uninsured patients increased from 7.5% to 9.3% between the predisenrollment and postdisenrollment periods, while decreasing slightly from 10.6% to 10.4% among TennCare beneficiaries. Higher admission rates among the uninsured may be related to the acuity of the illness, he explained.

“This is a very worrisome observation that should give states pause before they shed large numbers of people from the rolls of their Medicaid or Medicaid-equivalent program,” Dr. Arthur Kellermann, professor of emergency medicine and associate dean for health policy at Emory University in Atlanta, said during a discussion of the study. Dr. Kellermann called for additional analyses into the financial and health consequences of Tennessee's action.

Dr. Donald M. Yealy, professor of emergency medicine, University of Pittsburgh, concurred.

The challenge for emergency physicians is to integrate these outcomes into the broader health policy debate and describe “what really happens downstream and the cost of that, not just in dollars,” Dr. Yealy said.

The analysis, based on data from the Healthcare Cost and Utilization Project State Emergency Department database, supports recent findings from a similar study in which ED visits by the uninsured jumped 20% after Oregon disenrolled more than 50,000 Medicaid beneficiaries (Ann. Emerg. Med. 2008 April 15 [doi:10.1016/j.annemergmed.2008.01.335]).

Dr. Heavrin disclosed that the study was supported by a resident research grant from the Emergency Medicine Foundation.

CHICAGO—Medicaid cutbacks in Tennessee were associated with an abrupt and sustained increase in emergency department use and hospital admission among the uninsured, research shows.

In August 2005, the state of Tennessee disenrolled approximately 171,000 individuals older than 18 years from TennCare, the state's Medicaid managed care program.

Between the predisenrollment period of Jan. 1, 2004, through July 31, 2005, and the postdisenrollment period of Aug. 1, 2005, through July 31, 2006, ED visits by the uninsured increased by 95,464, or 4.5%, and decreased among TennCare beneficiaries by 160,823, or 6%.

“This research shows that health policy decisions have real effects on the patients we see in America's emergency departments,” said Dr. Benjamin S. Heavrin, who presented the study findings at the annual meeting of the American College of Emergency Physicians. “The cost savings from disenrollment resulted in an increasing proportion of uninsured patients in Tennessee's EDs. This suggests an increasing financial burden on the newly uninsured and a possible ominous shift in their health status, based on our admission data.”

The uninsured represented 12.7% of all patients in the EDs in the predisenrollment period, compared with 17.2% in the postdisenrollment period, Dr. Heavrin and his associates reported.

The largest weekly correlation (−0.95) between ED visits among the uninsured and TennCare beneficiaries corresponded exactly to the time when disenrollment began.

When ED use was calculated by calendar year, the incidence of ED visits among the uninsured increased by a relative 34.5%, from 44 visits per 100 persons per year in 2004 to 59.2 visits per 100 persons per year in 2006.

Total ED visits in the state decreased by 74,178 during the study period, which is predictable given a Medicaid population's use of the ED, according to Dr. Heavrin, chief resident, department of emergency medicine, Vanderbilt University Medical Center in Nashville, Tenn. A recent study showed that Medicaid enrollees visited the ED about three times more often than the uninsured (Med. Care 2008;46:1099–107).

An evaluation of admission data by Dr. Heavrin and his associates revealed that the admission rate of uninsured patients increased from 7.5% to 9.3% between the predisenrollment and postdisenrollment periods, while decreasing slightly from 10.6% to 10.4% among TennCare beneficiaries. Higher admission rates among the uninsured may be related to the acuity of the illness, he explained.

“This is a very worrisome observation that should give states pause before they shed large numbers of people from the rolls of their Medicaid or Medicaid-equivalent program,” Dr. Arthur Kellermann, professor of emergency medicine and associate dean for health policy at Emory University in Atlanta, said during a discussion of the study. Dr. Kellermann called for additional analyses into the financial and health consequences of Tennessee's action.

Dr. Donald M. Yealy, professor of emergency medicine, University of Pittsburgh, concurred.

The challenge for emergency physicians is to integrate these outcomes into the broader health policy debate and describe “what really happens downstream and the cost of that, not just in dollars,” Dr. Yealy said.

The analysis, based on data from the Healthcare Cost and Utilization Project State Emergency Department database, supports recent findings from a similar study in which ED visits by the uninsured jumped 20% after Oregon disenrolled more than 50,000 Medicaid beneficiaries (Ann. Emerg. Med. 2008 April 15 [doi:10.1016/j.annemergmed.2008.01.335]).

Dr. Heavrin disclosed that the study was supported by a resident research grant from the Emergency Medicine Foundation.

CHICAGO—Medicaid cutbacks in Tennessee were associated with an abrupt and sustained increase in emergency department use and hospital admission among the uninsured, research shows.

In August 2005, the state of Tennessee disenrolled approximately 171,000 individuals older than 18 years from TennCare, the state's Medicaid managed care program.

Between the predisenrollment period of Jan. 1, 2004, through July 31, 2005, and the postdisenrollment period of Aug. 1, 2005, through July 31, 2006, ED visits by the uninsured increased by 95,464, or 4.5%, and decreased among TennCare beneficiaries by 160,823, or 6%.

“This research shows that health policy decisions have real effects on the patients we see in America's emergency departments,” said Dr. Benjamin S. Heavrin, who presented the study findings at the annual meeting of the American College of Emergency Physicians. “The cost savings from disenrollment resulted in an increasing proportion of uninsured patients in Tennessee's EDs. This suggests an increasing financial burden on the newly uninsured and a possible ominous shift in their health status, based on our admission data.”

The uninsured represented 12.7% of all patients in the EDs in the predisenrollment period, compared with 17.2% in the postdisenrollment period, Dr. Heavrin and his associates reported.

The largest weekly correlation (−0.95) between ED visits among the uninsured and TennCare beneficiaries corresponded exactly to the time when disenrollment began.

When ED use was calculated by calendar year, the incidence of ED visits among the uninsured increased by a relative 34.5%, from 44 visits per 100 persons per year in 2004 to 59.2 visits per 100 persons per year in 2006.

Total ED visits in the state decreased by 74,178 during the study period, which is predictable given a Medicaid population's use of the ED, according to Dr. Heavrin, chief resident, department of emergency medicine, Vanderbilt University Medical Center in Nashville, Tenn. A recent study showed that Medicaid enrollees visited the ED about three times more often than the uninsured (Med. Care 2008;46:1099–107).

An evaluation of admission data by Dr. Heavrin and his associates revealed that the admission rate of uninsured patients increased from 7.5% to 9.3% between the predisenrollment and postdisenrollment periods, while decreasing slightly from 10.6% to 10.4% among TennCare beneficiaries. Higher admission rates among the uninsured may be related to the acuity of the illness, he explained.

“This is a very worrisome observation that should give states pause before they shed large numbers of people from the rolls of their Medicaid or Medicaid-equivalent program,” Dr. Arthur Kellermann, professor of emergency medicine and associate dean for health policy at Emory University in Atlanta, said during a discussion of the study. Dr. Kellermann called for additional analyses into the financial and health consequences of Tennessee's action.

Dr. Donald M. Yealy, professor of emergency medicine, University of Pittsburgh, concurred.

The challenge for emergency physicians is to integrate these outcomes into the broader health policy debate and describe “what really happens downstream and the cost of that, not just in dollars,” Dr. Yealy said.

The analysis, based on data from the Healthcare Cost and Utilization Project State Emergency Department database, supports recent findings from a similar study in which ED visits by the uninsured jumped 20% after Oregon disenrolled more than 50,000 Medicaid beneficiaries (Ann. Emerg. Med. 2008 April 15 [doi:10.1016/j.annemergmed.2008.01.335]).

Dr. Heavrin disclosed that the study was supported by a resident research grant from the Emergency Medicine Foundation.

CHICAGO — Medicaid cutbacks in Tennessee were associated with an abrupt and sustained increase in emergency department use and hospital admission among the uninsured, research shows.

In August 2005, the state of Tennessee disenrolled approximately 171,000 individuals older than 18 years from TennCare, the state's Medicaid managed care program.

Between the predisenrollment period of Jan. 1, 2004, through July 31, 2005, and the postdisenrollment period of Aug. 1, 2005, through July 31, 2006, ED visits by the uninsured increased by 95,464, or 4.5%, and decreased among TennCare beneficiaries by 160,823, or 6%.

“This research shows that health policy decisions have real effects on the patients we see in America's emergency departments,” said Dr. Benjamin S. Heavrin, who presented the study findings at the annual meeting of the American College of Emergency Physicians. “The cost savings from disenrollment resulted in an increasing proportion of uninsured patients in Tennessee's EDs. This suggests an increasing financial burden on the newly uninsured and a possible ominous shift in their health status, based on our admission data.”

The uninsured represented 12.7% of all patients in the EDs in the predisenrollment period, compared with 17.2% in the postdisenrollment period, Dr. Heavrin and his associates reported. The largest weekly correlation (−0.95) between ED visits among the uninsured and TennCare beneficiaries corresponded exactly to the time when disenrollment began.

When ED use was calculated by calendar year, the incidence of ED visits among the uninsured increased by a relative 34.5%, from 44 visits per 100 persons per year in 2004 to 59.2 visits per 100 persons per year in 2006.

Total ED visits in the state decreased by 74,178 during the study period, which is predictable given a Medicaid population's use of the ED, according to Dr. Heavrin, chief resident, department of emergency medicine, Vanderbilt University Medical Center in Nashville, Tenn. A recent study showed that Medicaid enrollees visited the ED about three times more often than the uninsured (Med. Care 2008;46:1099-107).

An evaluation of admission data by Dr. Heavrin and his associates revealed that the admission rate of uninsured patients increased from 7.5% to 9.3% between the predisenrollment and postdisenrollment periods, while decreasing slightly from 10.6% to 10.4% among TennCare beneficiaries.

Higher admission rates among the uninsured may be related to the acuity of the illness, Dr. Heavrin explained.

The analysis, based on data from the Healthcare Cost and Utilization Project State Emergency Department database, supports recent findings from a similar study in which ED visits by the uninsured jumped 20% after Oregon disenrolled more than 50,000 Medicaid beneficiaries (Ann. Emerg. Med. 2008 April 15 [doi:10.1016/j.annemergmed.2008.01.335

Dr. Heavrin disclosed that the study was supported by a resident research grant from the Emergency Medicine Foundation.

CHICAGO — Medicaid cutbacks in Tennessee were associated with an abrupt and sustained increase in emergency department use and hospital admission among the uninsured, research shows.

In August 2005, the state of Tennessee disenrolled approximately 171,000 individuals older than 18 years from TennCare, the state's Medicaid managed care program.

Between the predisenrollment period of Jan. 1, 2004, through July 31, 2005, and the postdisenrollment period of Aug. 1, 2005, through July 31, 2006, ED visits by the uninsured increased by 95,464, or 4.5%, and decreased among TennCare beneficiaries by 160,823, or 6%.

“This research shows that health policy decisions have real effects on the patients we see in America's emergency departments,” said Dr. Benjamin S. Heavrin, who presented the study findings at the annual meeting of the American College of Emergency Physicians. “The cost savings from disenrollment resulted in an increasing proportion of uninsured patients in Tennessee's EDs. This suggests an increasing financial burden on the newly uninsured and a possible ominous shift in their health status, based on our admission data.”

The uninsured represented 12.7% of all patients in the EDs in the predisenrollment period, compared with 17.2% in the postdisenrollment period, Dr. Heavrin and his associates reported. The largest weekly correlation (−0.95) between ED visits among the uninsured and TennCare beneficiaries corresponded exactly to the time when disenrollment began.

When ED use was calculated by calendar year, the incidence of ED visits among the uninsured increased by a relative 34.5%, from 44 visits per 100 persons per year in 2004 to 59.2 visits per 100 persons per year in 2006.

Total ED visits in the state decreased by 74,178 during the study period, which is predictable given a Medicaid population's use of the ED, according to Dr. Heavrin, chief resident, department of emergency medicine, Vanderbilt University Medical Center in Nashville, Tenn. A recent study showed that Medicaid enrollees visited the ED about three times more often than the uninsured (Med. Care 2008;46:1099-107).

An evaluation of admission data by Dr. Heavrin and his associates revealed that the admission rate of uninsured patients increased from 7.5% to 9.3% between the predisenrollment and postdisenrollment periods, while decreasing slightly from 10.6% to 10.4% among TennCare beneficiaries.

Higher admission rates among the uninsured may be related to the acuity of the illness, Dr. Heavrin explained.

The analysis, based on data from the Healthcare Cost and Utilization Project State Emergency Department database, supports recent findings from a similar study in which ED visits by the uninsured jumped 20% after Oregon disenrolled more than 50,000 Medicaid beneficiaries (Ann. Emerg. Med. 2008 April 15 [doi:10.1016/j.annemergmed.2008.01.335

Dr. Heavrin disclosed that the study was supported by a resident research grant from the Emergency Medicine Foundation.

CHICAGO — Medicaid cutbacks in Tennessee were associated with an abrupt and sustained increase in emergency department use and hospital admission among the uninsured, research shows.

In August 2005, the state of Tennessee disenrolled approximately 171,000 individuals older than 18 years from TennCare, the state's Medicaid managed care program.

Between the predisenrollment period of Jan. 1, 2004, through July 31, 2005, and the postdisenrollment period of Aug. 1, 2005, through July 31, 2006, ED visits by the uninsured increased by 95,464, or 4.5%, and decreased among TennCare beneficiaries by 160,823, or 6%.

“This research shows that health policy decisions have real effects on the patients we see in America's emergency departments,” said Dr. Benjamin S. Heavrin, who presented the study findings at the annual meeting of the American College of Emergency Physicians. “The cost savings from disenrollment resulted in an increasing proportion of uninsured patients in Tennessee's EDs. This suggests an increasing financial burden on the newly uninsured and a possible ominous shift in their health status, based on our admission data.”

The uninsured represented 12.7% of all patients in the EDs in the predisenrollment period, compared with 17.2% in the postdisenrollment period, Dr. Heavrin and his associates reported. The largest weekly correlation (−0.95) between ED visits among the uninsured and TennCare beneficiaries corresponded exactly to the time when disenrollment began.

When ED use was calculated by calendar year, the incidence of ED visits among the uninsured increased by a relative 34.5%, from 44 visits per 100 persons per year in 2004 to 59.2 visits per 100 persons per year in 2006.

Total ED visits in the state decreased by 74,178 during the study period, which is predictable given a Medicaid population's use of the ED, according to Dr. Heavrin, chief resident, department of emergency medicine, Vanderbilt University Medical Center in Nashville, Tenn. A recent study showed that Medicaid enrollees visited the ED about three times more often than the uninsured (Med. Care 2008;46:1099-107).

An evaluation of admission data by Dr. Heavrin and his associates revealed that the admission rate of uninsured patients increased from 7.5% to 9.3% between the predisenrollment and postdisenrollment periods, while decreasing slightly from 10.6% to 10.4% among TennCare beneficiaries.

Higher admission rates among the uninsured may be related to the acuity of the illness, Dr. Heavrin explained.

The analysis, based on data from the Healthcare Cost and Utilization Project State Emergency Department database, supports recent findings from a similar study in which ED visits by the uninsured jumped 20% after Oregon disenrolled more than 50,000 Medicaid beneficiaries (Ann. Emerg. Med. 2008 April 15 [doi:10.1016/j.annemergmed.2008.01.335

Dr. Heavrin disclosed that the study was supported by a resident research grant from the Emergency Medicine Foundation.

CHICAGO — Household cleaning sprays are meant to improve the indoor environment, but new research suggests they may actually contribute to new-onset adult asthma.

Aerosol cleaning sprays were associated with an increased risk for new asthma symptoms or medication use (relative risk 1.49) and for wheezing (RR 1.39) among 3,503 asthma-free adults, aged 20–44 years, surveyed in 10 European countries. If four or more sprays were used per week, the risk for new physician-diagnosed asthma increased (RR 2.11). No risk was detected from cleaning products not sprayed (Am. J. Respir. Crit. Care Med. 2007;176:735-41).

“I can't say if it pertains to children, but it seems logical to me,” Dr. Dennis R. Ownby said of the findings during a meeting sponsored by the American Academy of Pediatrics.

He highlighted the study to illustrate the importance of indoor air quality and respiratory health, particularly now that many Americans spend the majority of their time indoors. Pets and pests are known allergens, but it's important also to consider other common indoor air pollutants such as air fresheners, candles, sprays, stoves, and fireplaces. Cigarettes, fumes from dry cleaned clothes, and house paint also are sources of volatile organic compounds (VOCs) that can irritate lungs.

In a study comparing VOC exposure among 88 children with asthma and 104 age-matched controls (aged 6 months to 3 years), cases were exposed to significantly higher VOC levels than controls. For every 10-unit increase in the concentration of toluene and benzene (mcg/m

Dr. Ownby, chief of the allergy-immunology section and professor of pediatrics and medicine at the Medical College of Georgia, Augusta, also ran through some of the most common questions patients ask regarding efforts to reduce indoor irritants. Those questions include the following:

▸ Will steam cleaning carpets reduce allergens? No benefit was identified in the only controlled study to evaluate this issue. Moreover, it's the wrong way to go, Dr. Ownby said. To remove dust mites and pet allergens, it's best to remove carpeting from the home, particularly if it's laid on concrete floors, in which case the coolness of the floor and indoor humidity work to create a huge reservoir of allergens.

▸ Will washing a cat make it nonallergenic? Washing the cat or removing it from the home for short periods of time does little to improve air quality because it takes 12–16 weeks to reduce cat allergen levels down to the level of a house without a cat.

If removing the pet from the home is not an option, Dr. Ownby suggested keeping it out of the bedroom, keeping the bedroom door closed, and removing upholstered furniture and carpets from the home.

▸ Will a humidifier help control allergens? A study of 3,535 school children in southern California identified 256 (7%) new cases of asthma when the children were followed for 5 years or until graduation. The biggest risk factorfor the development of asthma was the presence of a humidifier in the home (RR 1.7)—beating out the presence of any pet (RR 1.6) or the family dog (RR 1.4) (Epidemiology 2002;13:288-95).

Dr. Ownby suggested reducing the indoor humidity to below 60%, with the optimal setting being 30%–50%.

▸ Can I keep pets if I use a HEPA air cleaner? Dr. Ownby does not recommend air filters for patients with pet allergens. He cited a study in which 35 cat-allergic patients (aged 18–65 years) with asthma or rhinitis who had one or more cats in the home were randomized to use air cleaners with or without HEPA filters. Despite applying an impermeable mattress cover, removing cats from the bedroom, and running the cleaners 90% of the time, after 6 months there was no significant difference between the two groups in nasal or chest symptoms, peak flow rates, sleep disturbance, medication use, or settled dust levels (Am. J. Respir. Crit. Care Med. 1998;158:115-20).

Dr. Ownby suggests that families who are interested in reducing irritants in their homes should minimize exposure to smoke from cigarettes or incense, sprayed products, products with strong odors including air fresheners, and unvented combustion sources. Allergen control should include eliminating the source or blocking exposure, reducing humidity and allergen reservoirs, and improving ventilation.

“We just don't ventilate our homes nearly as well as we should,” he said.

Dr. Ownby reported receiving research support from the National Institutes of Health and serving as a consultant to CarboNix, LLC.

CHICAGO — Household cleaning sprays are meant to improve the indoor environment, but new research suggests they may actually contribute to new-onset adult asthma.

Aerosol cleaning sprays were associated with an increased risk for new asthma symptoms or medication use (relative risk 1.49) and for wheezing (RR 1.39) among 3,503 asthma-free adults, aged 20–44 years, surveyed in 10 European countries. If four or more sprays were used per week, the risk for new physician-diagnosed asthma increased (RR 2.11). No risk was detected from cleaning products not sprayed (Am. J. Respir. Crit. Care Med. 2007;176:735-41).

“I can't say if it pertains to children, but it seems logical to me,” Dr. Dennis R. Ownby said of the findings during a meeting sponsored by the American Academy of Pediatrics.

He highlighted the study to illustrate the importance of indoor air quality and respiratory health, particularly now that many Americans spend the majority of their time indoors. Pets and pests are known allergens, but it's important also to consider other common indoor air pollutants such as air fresheners, candles, sprays, stoves, and fireplaces. Cigarettes, fumes from dry cleaned clothes, and house paint also are sources of volatile organic compounds (VOCs) that can irritate lungs.

In a study comparing VOC exposure among 88 children with asthma and 104 age-matched controls (aged 6 months to 3 years), cases were exposed to significantly higher VOC levels than controls. For every 10-unit increase in the concentration of toluene and benzene (mcg/m

Dr. Ownby, chief of the allergy-immunology section and professor of pediatrics and medicine at the Medical College of Georgia, Augusta, also ran through some of the most common questions patients ask regarding efforts to reduce indoor irritants. Those questions include the following:

▸ Will steam cleaning carpets reduce allergens? No benefit was identified in the only controlled study to evaluate this issue. Moreover, it's the wrong way to go, Dr. Ownby said. To remove dust mites and pet allergens, it's best to remove carpeting from the home, particularly if it's laid on concrete floors, in which case the coolness of the floor and indoor humidity work to create a huge reservoir of allergens.

▸ Will washing a cat make it nonallergenic? Washing the cat or removing it from the home for short periods of time does little to improve air quality because it takes 12–16 weeks to reduce cat allergen levels down to the level of a house without a cat.

If removing the pet from the home is not an option, Dr. Ownby suggested keeping it out of the bedroom, keeping the bedroom door closed, and removing upholstered furniture and carpets from the home.

▸ Will a humidifier help control allergens? A study of 3,535 school children in southern California identified 256 (7%) new cases of asthma when the children were followed for 5 years or until graduation. The biggest risk factorfor the development of asthma was the presence of a humidifier in the home (RR 1.7)—beating out the presence of any pet (RR 1.6) or the family dog (RR 1.4) (Epidemiology 2002;13:288-95).

Dr. Ownby suggested reducing the indoor humidity to below 60%, with the optimal setting being 30%–50%.

▸ Can I keep pets if I use a HEPA air cleaner? Dr. Ownby does not recommend air filters for patients with pet allergens. He cited a study in which 35 cat-allergic patients (aged 18–65 years) with asthma or rhinitis who had one or more cats in the home were randomized to use air cleaners with or without HEPA filters. Despite applying an impermeable mattress cover, removing cats from the bedroom, and running the cleaners 90% of the time, after 6 months there was no significant difference between the two groups in nasal or chest symptoms, peak flow rates, sleep disturbance, medication use, or settled dust levels (Am. J. Respir. Crit. Care Med. 1998;158:115-20).

Dr. Ownby suggests that families who are interested in reducing irritants in their homes should minimize exposure to smoke from cigarettes or incense, sprayed products, products with strong odors including air fresheners, and unvented combustion sources. Allergen control should include eliminating the source or blocking exposure, reducing humidity and allergen reservoirs, and improving ventilation.

“We just don't ventilate our homes nearly as well as we should,” he said.

Dr. Ownby reported receiving research support from the National Institutes of Health and serving as a consultant to CarboNix, LLC.

CHICAGO — Household cleaning sprays are meant to improve the indoor environment, but new research suggests they may actually contribute to new-onset adult asthma.

Aerosol cleaning sprays were associated with an increased risk for new asthma symptoms or medication use (relative risk 1.49) and for wheezing (RR 1.39) among 3,503 asthma-free adults, aged 20–44 years, surveyed in 10 European countries. If four or more sprays were used per week, the risk for new physician-diagnosed asthma increased (RR 2.11). No risk was detected from cleaning products not sprayed (Am. J. Respir. Crit. Care Med. 2007;176:735-41).

“I can't say if it pertains to children, but it seems logical to me,” Dr. Dennis R. Ownby said of the findings during a meeting sponsored by the American Academy of Pediatrics.

He highlighted the study to illustrate the importance of indoor air quality and respiratory health, particularly now that many Americans spend the majority of their time indoors. Pets and pests are known allergens, but it's important also to consider other common indoor air pollutants such as air fresheners, candles, sprays, stoves, and fireplaces. Cigarettes, fumes from dry cleaned clothes, and house paint also are sources of volatile organic compounds (VOCs) that can irritate lungs.

In a study comparing VOC exposure among 88 children with asthma and 104 age-matched controls (aged 6 months to 3 years), cases were exposed to significantly higher VOC levels than controls. For every 10-unit increase in the concentration of toluene and benzene (mcg/m

Dr. Ownby, chief of the allergy-immunology section and professor of pediatrics and medicine at the Medical College of Georgia, Augusta, also ran through some of the most common questions patients ask regarding efforts to reduce indoor irritants. Those questions include the following:

▸ Will steam cleaning carpets reduce allergens? No benefit was identified in the only controlled study to evaluate this issue. Moreover, it's the wrong way to go, Dr. Ownby said. To remove dust mites and pet allergens, it's best to remove carpeting from the home, particularly if it's laid on concrete floors, in which case the coolness of the floor and indoor humidity work to create a huge reservoir of allergens.

▸ Will washing a cat make it nonallergenic? Washing the cat or removing it from the home for short periods of time does little to improve air quality because it takes 12–16 weeks to reduce cat allergen levels down to the level of a house without a cat.

If removing the pet from the home is not an option, Dr. Ownby suggested keeping it out of the bedroom, keeping the bedroom door closed, and removing upholstered furniture and carpets from the home.

▸ Will a humidifier help control allergens? A study of 3,535 school children in southern California identified 256 (7%) new cases of asthma when the children were followed for 5 years or until graduation. The biggest risk factorfor the development of asthma was the presence of a humidifier in the home (RR 1.7)—beating out the presence of any pet (RR 1.6) or the family dog (RR 1.4) (Epidemiology 2002;13:288-95).

Dr. Ownby suggested reducing the indoor humidity to below 60%, with the optimal setting being 30%–50%.

▸ Can I keep pets if I use a HEPA air cleaner? Dr. Ownby does not recommend air filters for patients with pet allergens. He cited a study in which 35 cat-allergic patients (aged 18–65 years) with asthma or rhinitis who had one or more cats in the home were randomized to use air cleaners with or without HEPA filters. Despite applying an impermeable mattress cover, removing cats from the bedroom, and running the cleaners 90% of the time, after 6 months there was no significant difference between the two groups in nasal or chest symptoms, peak flow rates, sleep disturbance, medication use, or settled dust levels (Am. J. Respir. Crit. Care Med. 1998;158:115-20).

Dr. Ownby suggests that families who are interested in reducing irritants in their homes should minimize exposure to smoke from cigarettes or incense, sprayed products, products with strong odors including air fresheners, and unvented combustion sources. Allergen control should include eliminating the source or blocking exposure, reducing humidity and allergen reservoirs, and improving ventilation.

“We just don't ventilate our homes nearly as well as we should,” he said.

Dr. Ownby reported receiving research support from the National Institutes of Health and serving as a consultant to CarboNix, LLC.

CHICAGO — A topical coal-tar solution that doesn't smell, a user-friendly hydrogel patch, and supraerythemogenic phototherapy were among the innovative approaches to psoriasis discussed at the American Academy of Dermatology Academy's 2008 meeting.

The NeoStrata Co. has launched Psorent, a steroid-free topical coal-tar solution that uses a novel, lightly occlusive liquid wax vehicle to reduce the odor and staining that caused traditional coal-tar solutions to fall out of favor. It contains 15% liquor carbonis distillate, equivalent to 2.3% coal tar, is available without a prescription, and features a dab-on applicator that avoids touching the solution or plaques.

In an ongoing NeoStrata-supported trial of patients with moderate plaque psoriasis, significantly more patients (30% of 23) randomized to twice-daily Psorent had at least a 75% reduction in Psoriasis Area and Severity Index (PASI) scores at 12 weeks, compared with none of the 25 patients randomized to twice-daily calcipotriol cream 0.005% (Dovonex).

Patients rated Psorent as “very easy” or “extremely easy” to use and its scent and staining near neutral. Treatment-related adverse events were comparable for both groups, according to interim results for 48 patients reported in a poster by principal investigator Dr. Alexandra B. Kimball of Massachusetts General and Brigham and Women's hospitals, Boston, and associates.

In a psoriasis symposium at the meeting, Dr. Jerry Bagel discussed a second study comparing narrow-band UVB phototherapy three times a week for 12 weeks plus twice-daily Psorent or placebo. At week 4, 75% of patients treated with Psorent plus phototherapy were clear or almost clear, whereas it took 7 weeks to clear with placebo plus phototherapy.

“This may be an effective modality to add on to phototherapy to decrease the amount of treatments, co-pays, and now the cost of driving to psoriasis centers,” said Dr. Bagel, a dermatologist in private practice in East Windsor, N.J.

Dr. John Koo said the Envela (Teikoku Pharma USA Inc.) hydrogel occlusion patch might finally make occlusion therapy feasible for psoriasis.

The dressing is composed of a hydrogel layer on a very thin and flexible, skin-colored, gas- and water-impermeable urethane backing. Unlike other patches, Saran wrap, or tapes, Envela appears to be both reasonably priced and user friendly, he said.

In an open-label study in 120 patients with mild to severe plaque psoriasis, twice-daily dressing with Envela alone produced some improvements, but noticeably enhanced efficacy and penetration when combined with hydrocortisone 1% cream, tacrolimus, and halobetasol, said Dr. Koo, professor and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco.

Although the treatment was recently approved by the U.S. Food and Drug Administration, Envela's launch has been delayed for internal reasons, Ms. Mia Maslanka of Teikoku product development said in an interview.

Dr. Koo also discussed the potential of supraerythemogenic phototherapy. Traditional phototherapy is limited by its ability to deliver only a minimal erythema dose (MED) to avoid burning healthy skin at the margins of psoriasis. Supraerythemogenic phototherapy uses fiber optic-targeted application of narrow-band UVB to deliver many times the MED to plaques in a single treatment session. This makes phototherapy more aggressive, but healthy skin is spared because the application targets only plaques, which are more tolerant to high-dose UVB and don't burn, he said.

Patients might be cleared in only 10 treatments instead of the traditional 30–40 treatments, making phototherapy much easier to do, Dr. Koo added.

Dr. Kimball is a study investigator for Psorent and has participated in an advisory board meeting for NeoStrata. Dr. Bagel had no conflicts of interest in regards to Psorent. Dr. Koo has been an investigator for Teikoku but was not compensated.

An abdominal psoriatic plaque is shown at baseline (left) and after 4 weeks (middle) and 12 weeks of twice daily treatment with topical Psorent solution. Photos courtesy Dr. Alexa B. Kimball

CHICAGO — A topical coal-tar solution that doesn't smell, a user-friendly hydrogel patch, and supraerythemogenic phototherapy were among the innovative approaches to psoriasis discussed at the American Academy of Dermatology Academy's 2008 meeting.

The NeoStrata Co. has launched Psorent, a steroid-free topical coal-tar solution that uses a novel, lightly occlusive liquid wax vehicle to reduce the odor and staining that caused traditional coal-tar solutions to fall out of favor. It contains 15% liquor carbonis distillate, equivalent to 2.3% coal tar, is available without a prescription, and features a dab-on applicator that avoids touching the solution or plaques.

In an ongoing NeoStrata-supported trial of patients with moderate plaque psoriasis, significantly more patients (30% of 23) randomized to twice-daily Psorent had at least a 75% reduction in Psoriasis Area and Severity Index (PASI) scores at 12 weeks, compared with none of the 25 patients randomized to twice-daily calcipotriol cream 0.005% (Dovonex).

Patients rated Psorent as “very easy” or “extremely easy” to use and its scent and staining near neutral. Treatment-related adverse events were comparable for both groups, according to interim results for 48 patients reported in a poster by principal investigator Dr. Alexandra B. Kimball of Massachusetts General and Brigham and Women's hospitals, Boston, and associates.

In a psoriasis symposium at the meeting, Dr. Jerry Bagel discussed a second study comparing narrow-band UVB phototherapy three times a week for 12 weeks plus twice-daily Psorent or placebo. At week 4, 75% of patients treated with Psorent plus phototherapy were clear or almost clear, whereas it took 7 weeks to clear with placebo plus phototherapy.

“This may be an effective modality to add on to phototherapy to decrease the amount of treatments, co-pays, and now the cost of driving to psoriasis centers,” said Dr. Bagel, a dermatologist in private practice in East Windsor, N.J.

Dr. John Koo said the Envela (Teikoku Pharma USA Inc.) hydrogel occlusion patch might finally make occlusion therapy feasible for psoriasis.

The dressing is composed of a hydrogel layer on a very thin and flexible, skin-colored, gas- and water-impermeable urethane backing. Unlike other patches, Saran wrap, or tapes, Envela appears to be both reasonably priced and user friendly, he said.

In an open-label study in 120 patients with mild to severe plaque psoriasis, twice-daily dressing with Envela alone produced some improvements, but noticeably enhanced efficacy and penetration when combined with hydrocortisone 1% cream, tacrolimus, and halobetasol, said Dr. Koo, professor and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco.

Although the treatment was recently approved by the U.S. Food and Drug Administration, Envela's launch has been delayed for internal reasons, Ms. Mia Maslanka of Teikoku product development said in an interview.

Dr. Koo also discussed the potential of supraerythemogenic phototherapy. Traditional phototherapy is limited by its ability to deliver only a minimal erythema dose (MED) to avoid burning healthy skin at the margins of psoriasis. Supraerythemogenic phototherapy uses fiber optic-targeted application of narrow-band UVB to deliver many times the MED to plaques in a single treatment session. This makes phototherapy more aggressive, but healthy skin is spared because the application targets only plaques, which are more tolerant to high-dose UVB and don't burn, he said.

Patients might be cleared in only 10 treatments instead of the traditional 30–40 treatments, making phototherapy much easier to do, Dr. Koo added.

Dr. Kimball is a study investigator for Psorent and has participated in an advisory board meeting for NeoStrata. Dr. Bagel had no conflicts of interest in regards to Psorent. Dr. Koo has been an investigator for Teikoku but was not compensated.

An abdominal psoriatic plaque is shown at baseline (left) and after 4 weeks (middle) and 12 weeks of twice daily treatment with topical Psorent solution. Photos courtesy Dr. Alexa B. Kimball

CHICAGO — A topical coal-tar solution that doesn't smell, a user-friendly hydrogel patch, and supraerythemogenic phototherapy were among the innovative approaches to psoriasis discussed at the American Academy of Dermatology Academy's 2008 meeting.

The NeoStrata Co. has launched Psorent, a steroid-free topical coal-tar solution that uses a novel, lightly occlusive liquid wax vehicle to reduce the odor and staining that caused traditional coal-tar solutions to fall out of favor. It contains 15% liquor carbonis distillate, equivalent to 2.3% coal tar, is available without a prescription, and features a dab-on applicator that avoids touching the solution or plaques.

In an ongoing NeoStrata-supported trial of patients with moderate plaque psoriasis, significantly more patients (30% of 23) randomized to twice-daily Psorent had at least a 75% reduction in Psoriasis Area and Severity Index (PASI) scores at 12 weeks, compared with none of the 25 patients randomized to twice-daily calcipotriol cream 0.005% (Dovonex).

Patients rated Psorent as “very easy” or “extremely easy” to use and its scent and staining near neutral. Treatment-related adverse events were comparable for both groups, according to interim results for 48 patients reported in a poster by principal investigator Dr. Alexandra B. Kimball of Massachusetts General and Brigham and Women's hospitals, Boston, and associates.

In a psoriasis symposium at the meeting, Dr. Jerry Bagel discussed a second study comparing narrow-band UVB phototherapy three times a week for 12 weeks plus twice-daily Psorent or placebo. At week 4, 75% of patients treated with Psorent plus phototherapy were clear or almost clear, whereas it took 7 weeks to clear with placebo plus phototherapy.

“This may be an effective modality to add on to phototherapy to decrease the amount of treatments, co-pays, and now the cost of driving to psoriasis centers,” said Dr. Bagel, a dermatologist in private practice in East Windsor, N.J.

Dr. John Koo said the Envela (Teikoku Pharma USA Inc.) hydrogel occlusion patch might finally make occlusion therapy feasible for psoriasis.

The dressing is composed of a hydrogel layer on a very thin and flexible, skin-colored, gas- and water-impermeable urethane backing. Unlike other patches, Saran wrap, or tapes, Envela appears to be both reasonably priced and user friendly, he said.

In an open-label study in 120 patients with mild to severe plaque psoriasis, twice-daily dressing with Envela alone produced some improvements, but noticeably enhanced efficacy and penetration when combined with hydrocortisone 1% cream, tacrolimus, and halobetasol, said Dr. Koo, professor and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco.

Although the treatment was recently approved by the U.S. Food and Drug Administration, Envela's launch has been delayed for internal reasons, Ms. Mia Maslanka of Teikoku product development said in an interview.

Dr. Koo also discussed the potential of supraerythemogenic phototherapy. Traditional phototherapy is limited by its ability to deliver only a minimal erythema dose (MED) to avoid burning healthy skin at the margins of psoriasis. Supraerythemogenic phototherapy uses fiber optic-targeted application of narrow-band UVB to deliver many times the MED to plaques in a single treatment session. This makes phototherapy more aggressive, but healthy skin is spared because the application targets only plaques, which are more tolerant to high-dose UVB and don't burn, he said.

Patients might be cleared in only 10 treatments instead of the traditional 30–40 treatments, making phototherapy much easier to do, Dr. Koo added.

Dr. Kimball is a study investigator for Psorent and has participated in an advisory board meeting for NeoStrata. Dr. Bagel had no conflicts of interest in regards to Psorent. Dr. Koo has been an investigator for Teikoku but was not compensated.

An abdominal psoriatic plaque is shown at baseline (left) and after 4 weeks (middle) and 12 weeks of twice daily treatment with topical Psorent solution. Photos courtesy Dr. Alexa B. Kimball

CHICAGO – Patients who were suffering from depression at the time of malignant brain astrocytoma surgery had significantly reduced survival compared with nondepressed patients in a retrospective analysis of 1,052 patients.

Although no causative association can be inferred because of the study's retrospective design, recognizing and treating preoperative depression could maximize survival in patients with malignant brain tumors, said Dr. Alfredo Quiñones-Hinojosa at the annual meeting of the American Association of Neurological Surgeons.

Currently, patient age, tumor grade, and functional status are known preoperative prognostic indicators of survival. Identification of any reversible comorbidity would be important, as malignant astrocytoma, also known as glioma or glioblastoma multiforme, typically results in death in about 1 year, even with the latest, most effective therapies.

Researchers at Johns Hopkins School of Medicine in Baltimore, led by Dr. Matthew J. McGirt, analyzed the outcomes of 1,052 patients with malignant astrocytoma who underwent surgery from 1995 to 2006.

Of these patients, 605 underwent primary resection, 410 underwent secondary resection, and 37 had a biopsy only. Excluding the biopsies, 213 tumors were World Health Organization grade III and 802 tumors were grade IV. A total of 204 patients received subtotal resection, 274 received adjuvant therapy, and 136 required subsequent resection.

Only 49 patients (5%) who were taking antidepressant medication for clinical depression at the time of the surgery met the study's definition of having depression.

All demographic and clinical characteristics were similar between the two groups, said Dr. Quiñones-Hinojosa. Their mean age was 51 years and median preoperative Karnofsky Performance Scale (KPS) score was 80. Among survivors, the median follow-up was 12 months (range 3–18 months).

In a Kaplan Meier analysis, patients with depression had more than a 40% increase in the relative risk of mortality compared with nondepressed patients (relative risk 1.41), regardless of KPS, WHO tumor grade, patient age, or clinical presentation.

Median survival was 7 months among patients with depression, compared with 11 months in those without depression. At 2 years post surgery, 5% of patients with depression were alive, compared with 23% of nondepressed patients. The difference was significant.

Dr. Quiñones-Hinojosa acknowledged that the investigators could not be certain that the patients' depression was not a response to the recent diagnosis of a terminal disease. In addition, many patients with clinical depression may have been undiagnosed and unmedicated.

CHICAGO – Patients who were suffering from depression at the time of malignant brain astrocytoma surgery had significantly reduced survival compared with nondepressed patients in a retrospective analysis of 1,052 patients.

Although no causative association can be inferred because of the study's retrospective design, recognizing and treating preoperative depression could maximize survival in patients with malignant brain tumors, said Dr. Alfredo Quiñones-Hinojosa at the annual meeting of the American Association of Neurological Surgeons.

Currently, patient age, tumor grade, and functional status are known preoperative prognostic indicators of survival. Identification of any reversible comorbidity would be important, as malignant astrocytoma, also known as glioma or glioblastoma multiforme, typically results in death in about 1 year, even with the latest, most effective therapies.

Researchers at Johns Hopkins School of Medicine in Baltimore, led by Dr. Matthew J. McGirt, analyzed the outcomes of 1,052 patients with malignant astrocytoma who underwent surgery from 1995 to 2006.

Of these patients, 605 underwent primary resection, 410 underwent secondary resection, and 37 had a biopsy only. Excluding the biopsies, 213 tumors were World Health Organization grade III and 802 tumors were grade IV. A total of 204 patients received subtotal resection, 274 received adjuvant therapy, and 136 required subsequent resection.

Only 49 patients (5%) who were taking antidepressant medication for clinical depression at the time of the surgery met the study's definition of having depression.

All demographic and clinical characteristics were similar between the two groups, said Dr. Quiñones-Hinojosa. Their mean age was 51 years and median preoperative Karnofsky Performance Scale (KPS) score was 80. Among survivors, the median follow-up was 12 months (range 3–18 months).

In a Kaplan Meier analysis, patients with depression had more than a 40% increase in the relative risk of mortality compared with nondepressed patients (relative risk 1.41), regardless of KPS, WHO tumor grade, patient age, or clinical presentation.

Median survival was 7 months among patients with depression, compared with 11 months in those without depression. At 2 years post surgery, 5% of patients with depression were alive, compared with 23% of nondepressed patients. The difference was significant.

Dr. Quiñones-Hinojosa acknowledged that the investigators could not be certain that the patients' depression was not a response to the recent diagnosis of a terminal disease. In addition, many patients with clinical depression may have been undiagnosed and unmedicated.

CHICAGO – Patients who were suffering from depression at the time of malignant brain astrocytoma surgery had significantly reduced survival compared with nondepressed patients in a retrospective analysis of 1,052 patients.

Although no causative association can be inferred because of the study's retrospective design, recognizing and treating preoperative depression could maximize survival in patients with malignant brain tumors, said Dr. Alfredo Quiñones-Hinojosa at the annual meeting of the American Association of Neurological Surgeons.

Currently, patient age, tumor grade, and functional status are known preoperative prognostic indicators of survival. Identification of any reversible comorbidity would be important, as malignant astrocytoma, also known as glioma or glioblastoma multiforme, typically results in death in about 1 year, even with the latest, most effective therapies.

Researchers at Johns Hopkins School of Medicine in Baltimore, led by Dr. Matthew J. McGirt, analyzed the outcomes of 1,052 patients with malignant astrocytoma who underwent surgery from 1995 to 2006.

Of these patients, 605 underwent primary resection, 410 underwent secondary resection, and 37 had a biopsy only. Excluding the biopsies, 213 tumors were World Health Organization grade III and 802 tumors were grade IV. A total of 204 patients received subtotal resection, 274 received adjuvant therapy, and 136 required subsequent resection.

Only 49 patients (5%) who were taking antidepressant medication for clinical depression at the time of the surgery met the study's definition of having depression.

All demographic and clinical characteristics were similar between the two groups, said Dr. Quiñones-Hinojosa. Their mean age was 51 years and median preoperative Karnofsky Performance Scale (KPS) score was 80. Among survivors, the median follow-up was 12 months (range 3–18 months).

In a Kaplan Meier analysis, patients with depression had more than a 40% increase in the relative risk of mortality compared with nondepressed patients (relative risk 1.41), regardless of KPS, WHO tumor grade, patient age, or clinical presentation.

Median survival was 7 months among patients with depression, compared with 11 months in those without depression. At 2 years post surgery, 5% of patients with depression were alive, compared with 23% of nondepressed patients. The difference was significant.

Dr. Quiñones-Hinojosa acknowledged that the investigators could not be certain that the patients' depression was not a response to the recent diagnosis of a terminal disease. In addition, many patients with clinical depression may have been undiagnosed and unmedicated.

STOCKHOLM — The genetic assay MammaPrint was able to identify a substantial proportion of women with small, early-stage breast tumors who were at risk for distant metastases, according to a study in 319 women.

The study included women with lymph node-negative T1 breast cancer, a group generally regarded as low-risk patients. Among 39 women with tumors smaller than 11 mm, 19 (49%) had a good-prognosis signature as determined by the MammaPrint assay, and 20 (51%) had a poor-prognosis signature.

Overall, the 10-year distant metastasis-free survival rate was greater than 90% among those with a good-prognosis signature, compared with 60% among those with a poor-prognosis signature, according to results reported in a poster presentation at the European Society for Medical Oncology Congress.

In the 280 women with tumors measuring 11-20 mm, the probability of remaining free of distant metastases at 10 years was 85% for those with a good-prognosis signature and 60% for those with a poor-prognosis signature.

The probability of remaining metastasis free was significantly different between prognosis-signature groups for either tumor size. “We've already shown that MammaPrint can distinguish high-risk patients with poor survival rates, but even in patients who are considered clinically to have a good outcome, we see that 50% of these patients actually have a poor prognosis,” coinvestigator Dr. Femke de Snoo, director of medical affairs, Agendia BV, Amsterdam, said in an interview.

The MammaPrint breast cancer prognostic test measures the expression of 70 genes in tumor samples. It is cleared for use by the Food and Drug Administration, and made by Agendia BV, which sponsored the study.

In an effort to underscore that the MammaPrint assay adds information to all risk categories, the investigators performed a subgroup analysis in 145 women with lymph node-negative, estrogen receptor-positive, grade 2 tumors.

The 10-year overall survival rate was significantly different among 90 women with a good-prognosis signature, as compared with 55 women with a poor-prognosis signature (92% vs. 60%), according to the investigators, led by Dr. Annuska M. Glas, also of Agendia BV.

Poster discussant Dr. Fabrice André of the Gustave-Roussy Institute in Villejuif, France, said that the number of women with small tumors of the breast is increasing with mass screening. If the current data are reproduced in cross-validation retrospective studies, MammaPrint could be used in clinical practice to identify women who are eligible for chemotherapy among this good-prognosis population, Dr. André said. He cautioned, however, that randomized, controlled trials are needed before molecular assays should be used to decrease the use of adjuvant treatment in this population.

We've shown that MammaPrint can distinguish high-risk patients with poor survival rates. DR. DE SNOO

STOCKHOLM — The genetic assay MammaPrint was able to identify a substantial proportion of women with small, early-stage breast tumors who were at risk for distant metastases, according to a study in 319 women.

The study included women with lymph node-negative T1 breast cancer, a group generally regarded as low-risk patients. Among 39 women with tumors smaller than 11 mm, 19 (49%) had a good-prognosis signature as determined by the MammaPrint assay, and 20 (51%) had a poor-prognosis signature.

Overall, the 10-year distant metastasis-free survival rate was greater than 90% among those with a good-prognosis signature, compared with 60% among those with a poor-prognosis signature, according to results reported in a poster presentation at the European Society for Medical Oncology Congress.

In the 280 women with tumors measuring 11-20 mm, the probability of remaining free of distant metastases at 10 years was 85% for those with a good-prognosis signature and 60% for those with a poor-prognosis signature.

The probability of remaining metastasis free was significantly different between prognosis-signature groups for either tumor size. “We've already shown that MammaPrint can distinguish high-risk patients with poor survival rates, but even in patients who are considered clinically to have a good outcome, we see that 50% of these patients actually have a poor prognosis,” coinvestigator Dr. Femke de Snoo, director of medical affairs, Agendia BV, Amsterdam, said in an interview.

The MammaPrint breast cancer prognostic test measures the expression of 70 genes in tumor samples. It is cleared for use by the Food and Drug Administration, and made by Agendia BV, which sponsored the study.

In an effort to underscore that the MammaPrint assay adds information to all risk categories, the investigators performed a subgroup analysis in 145 women with lymph node-negative, estrogen receptor-positive, grade 2 tumors.

The 10-year overall survival rate was significantly different among 90 women with a good-prognosis signature, as compared with 55 women with a poor-prognosis signature (92% vs. 60%), according to the investigators, led by Dr. Annuska M. Glas, also of Agendia BV.

Poster discussant Dr. Fabrice André of the Gustave-Roussy Institute in Villejuif, France, said that the number of women with small tumors of the breast is increasing with mass screening. If the current data are reproduced in cross-validation retrospective studies, MammaPrint could be used in clinical practice to identify women who are eligible for chemotherapy among this good-prognosis population, Dr. André said. He cautioned, however, that randomized, controlled trials are needed before molecular assays should be used to decrease the use of adjuvant treatment in this population.

We've shown that MammaPrint can distinguish high-risk patients with poor survival rates. DR. DE SNOO

STOCKHOLM — The genetic assay MammaPrint was able to identify a substantial proportion of women with small, early-stage breast tumors who were at risk for distant metastases, according to a study in 319 women.

The study included women with lymph node-negative T1 breast cancer, a group generally regarded as low-risk patients. Among 39 women with tumors smaller than 11 mm, 19 (49%) had a good-prognosis signature as determined by the MammaPrint assay, and 20 (51%) had a poor-prognosis signature.

Overall, the 10-year distant metastasis-free survival rate was greater than 90% among those with a good-prognosis signature, compared with 60% among those with a poor-prognosis signature, according to results reported in a poster presentation at the European Society for Medical Oncology Congress.

In the 280 women with tumors measuring 11-20 mm, the probability of remaining free of distant metastases at 10 years was 85% for those with a good-prognosis signature and 60% for those with a poor-prognosis signature.

The probability of remaining metastasis free was significantly different between prognosis-signature groups for either tumor size. “We've already shown that MammaPrint can distinguish high-risk patients with poor survival rates, but even in patients who are considered clinically to have a good outcome, we see that 50% of these patients actually have a poor prognosis,” coinvestigator Dr. Femke de Snoo, director of medical affairs, Agendia BV, Amsterdam, said in an interview.

The MammaPrint breast cancer prognostic test measures the expression of 70 genes in tumor samples. It is cleared for use by the Food and Drug Administration, and made by Agendia BV, which sponsored the study.

In an effort to underscore that the MammaPrint assay adds information to all risk categories, the investigators performed a subgroup analysis in 145 women with lymph node-negative, estrogen receptor-positive, grade 2 tumors.

The 10-year overall survival rate was significantly different among 90 women with a good-prognosis signature, as compared with 55 women with a poor-prognosis signature (92% vs. 60%), according to the investigators, led by Dr. Annuska M. Glas, also of Agendia BV.

Poster discussant Dr. Fabrice André of the Gustave-Roussy Institute in Villejuif, France, said that the number of women with small tumors of the breast is increasing with mass screening. If the current data are reproduced in cross-validation retrospective studies, MammaPrint could be used in clinical practice to identify women who are eligible for chemotherapy among this good-prognosis population, Dr. André said. He cautioned, however, that randomized, controlled trials are needed before molecular assays should be used to decrease the use of adjuvant treatment in this population.

We've shown that MammaPrint can distinguish high-risk patients with poor survival rates. DR. DE SNOO

The use of two widely prescribed inhaled anticholinergics significantly increased the risk of cardiovascular death, myocardial infarction, or stroke by about 58% among patients with chronic obstructive pulmonary disease, according to the findings of a meta-analysis involving 14,783 patients.

During follow-up from 6 weeks to 5 years, cardiovascular death, MI, or stroke occurred in 135 of 7,472 patients (1.8%) receiving either inhaled tiotropium bromide or ipratropium bromide for more than 30 days, compared with 86 of 7,311 patients (1.2%) receiving control therapy (relative risk 1.58). The difference was significant.

However, inhaled anticholinergics did not significantly increase the risk of all-cause mortality, a secondary outcome of the meta-analysis (2.0% vs. 1.6% for control; RR 1.26).

“Clinicians and patients should carefully consider these potential long-term cardiovascular risks of inhaled anticholinergics in the treatment of COPD, and decide whether these risks are an acceptable trade-off in return for their symptomatic benefits,” wrote Dr. Sonal Singh of Wake Forest University, Winston-Salem, N.C., and associates (JAMA 2008;300:1439-50).

In the 17 studies included in the meta-analysis, patients had a diagnosis of COPD of any severity. They had received either inhaled tiotropium or ipratropium or control, which could be placebo or active control, including inhaled β-agonists or inhaled steroid β-agonist combinations.

Inhaled tiotropium is comarketed in the United States by Boehringer Ingelheim GmbH and Pfizer Inc. under the trade name Spiriva. Ipratropium is available generically and also is marketed by Boehringer Ingelheim as Atrovent.

In a statement, Pfizer and Boehringer Ingelheim said they “strongly disagree with the conclusion reached by Singh et al.,” and added that, “patients and physicians can be confident that Spiriva is a safe and effective medication.” The two companies released a new analysis of 30 controlled trials involving 19,545 patients with COPD. That analysis showed no increased risk of all-cause mortality, cardiac mortality, stroke, or MI (http://us.boehringeringelheim.com/newsroom/2008/09-23-08_spiriva_safety.html

The analysis includes unpublished data from the industry-sponsored UPLIFT (Understanding Potential Long-Term Impacts on Function With Tiotropium) trial, which were scheduled to be presented at a European Respiratory Society meeting in Berlin.

Earlier, Boehringer Ingelheim informed the Food and Drug Administration that ongoing safety monitoring had identified a “possible increased risk of stroke” in a safety analysis of 29 trials involving about 13,500 patients. That analysis estimated the risk of stroke was 8 patients/1,000 patients treated for 1 year with Spiriva, and 6 patients/1,000 per year for those treated with placebo (www.fda.gov/cder/drug/early_comm/tiotropium.htm

The investigators of the current meta-analysis acknowledged that the analysis was limited by the quality of reported data. Many of the trials analyzed were small and short term, resulting in few events.

“As a result of small numbers, the 95% [confidence intervals] are wide, resulting in some uncertainty as to the precise magnitude of the observed risk,” Dr. Singh and associates wrote. “None of these trials was specifically designed to monitor the risk of cardiovascular events, which were not adjudicated.”

A sensitivity analysis restricted to the five long-term studies (ranging from 48 weeks to 5 years) involving 7,267 patients confirmed the significantly increased risk of cardiovascular death, MI, and stroke (2.9% vs. 1.8% for controls; RR 1.73). However, there was no statistically significant increase in these events in a sensitivity analysis of the 12 short-term trials (ranging from 6 weeks to 26 weeks) involving 7,516 patients (0.6% vs. 0.6%; RR 1.16).

Dr. Singh and coauthor Dr. Yoon K. Loke of the University of East Anglia (England), Norwich, called for prospective, adequately powered trials with adjudication of cardiovascular events to assess the safety of inhaled anticholinergics in patients with COPD. The authors reported no financial disclosures.

The use of two widely prescribed inhaled anticholinergics significantly increased the risk of cardiovascular death, myocardial infarction, or stroke by about 58% among patients with chronic obstructive pulmonary disease, according to the findings of a meta-analysis involving 14,783 patients.

During follow-up from 6 weeks to 5 years, cardiovascular death, MI, or stroke occurred in 135 of 7,472 patients (1.8%) receiving either inhaled tiotropium bromide or ipratropium bromide for more than 30 days, compared with 86 of 7,311 patients (1.2%) receiving control therapy (relative risk 1.58). The difference was significant.

However, inhaled anticholinergics did not significantly increase the risk of all-cause mortality, a secondary outcome of the meta-analysis (2.0% vs. 1.6% for control; RR 1.26).

“Clinicians and patients should carefully consider these potential long-term cardiovascular risks of inhaled anticholinergics in the treatment of COPD, and decide whether these risks are an acceptable trade-off in return for their symptomatic benefits,” wrote Dr. Sonal Singh of Wake Forest University, Winston-Salem, N.C., and associates (JAMA 2008;300:1439-50).

In the 17 studies included in the meta-analysis, patients had a diagnosis of COPD of any severity. They had received either inhaled tiotropium or ipratropium or control, which could be placebo or active control, including inhaled β-agonists or inhaled steroid β-agonist combinations.

Inhaled tiotropium is comarketed in the United States by Boehringer Ingelheim GmbH and Pfizer Inc. under the trade name Spiriva. Ipratropium is available generically and also is marketed by Boehringer Ingelheim as Atrovent.

In a statement, Pfizer and Boehringer Ingelheim said they “strongly disagree with the conclusion reached by Singh et al.,” and added that, “patients and physicians can be confident that Spiriva is a safe and effective medication.” The two companies released a new analysis of 30 controlled trials involving 19,545 patients with COPD. That analysis showed no increased risk of all-cause mortality, cardiac mortality, stroke, or MI (http://us.boehringeringelheim.com/newsroom/2008/09-23-08_spiriva_safety.html

The analysis includes unpublished data from the industry-sponsored UPLIFT (Understanding Potential Long-Term Impacts on Function With Tiotropium) trial, which were scheduled to be presented at a European Respiratory Society meeting in Berlin.

Earlier, Boehringer Ingelheim informed the Food and Drug Administration that ongoing safety monitoring had identified a “possible increased risk of stroke” in a safety analysis of 29 trials involving about 13,500 patients. That analysis estimated the risk of stroke was 8 patients/1,000 patients treated for 1 year with Spiriva, and 6 patients/1,000 per year for those treated with placebo (www.fda.gov/cder/drug/early_comm/tiotropium.htm

The investigators of the current meta-analysis acknowledged that the analysis was limited by the quality of reported data. Many of the trials analyzed were small and short term, resulting in few events.

“As a result of small numbers, the 95% [confidence intervals] are wide, resulting in some uncertainty as to the precise magnitude of the observed risk,” Dr. Singh and associates wrote. “None of these trials was specifically designed to monitor the risk of cardiovascular events, which were not adjudicated.”

A sensitivity analysis restricted to the five long-term studies (ranging from 48 weeks to 5 years) involving 7,267 patients confirmed the significantly increased risk of cardiovascular death, MI, and stroke (2.9% vs. 1.8% for controls; RR 1.73). However, there was no statistically significant increase in these events in a sensitivity analysis of the 12 short-term trials (ranging from 6 weeks to 26 weeks) involving 7,516 patients (0.6% vs. 0.6%; RR 1.16).

Dr. Singh and coauthor Dr. Yoon K. Loke of the University of East Anglia (England), Norwich, called for prospective, adequately powered trials with adjudication of cardiovascular events to assess the safety of inhaled anticholinergics in patients with COPD. The authors reported no financial disclosures.

The use of two widely prescribed inhaled anticholinergics significantly increased the risk of cardiovascular death, myocardial infarction, or stroke by about 58% among patients with chronic obstructive pulmonary disease, according to the findings of a meta-analysis involving 14,783 patients.

During follow-up from 6 weeks to 5 years, cardiovascular death, MI, or stroke occurred in 135 of 7,472 patients (1.8%) receiving either inhaled tiotropium bromide or ipratropium bromide for more than 30 days, compared with 86 of 7,311 patients (1.2%) receiving control therapy (relative risk 1.58). The difference was significant.

However, inhaled anticholinergics did not significantly increase the risk of all-cause mortality, a secondary outcome of the meta-analysis (2.0% vs. 1.6% for control; RR 1.26).

“Clinicians and patients should carefully consider these potential long-term cardiovascular risks of inhaled anticholinergics in the treatment of COPD, and decide whether these risks are an acceptable trade-off in return for their symptomatic benefits,” wrote Dr. Sonal Singh of Wake Forest University, Winston-Salem, N.C., and associates (JAMA 2008;300:1439-50).

In the 17 studies included in the meta-analysis, patients had a diagnosis of COPD of any severity. They had received either inhaled tiotropium or ipratropium or control, which could be placebo or active control, including inhaled β-agonists or inhaled steroid β-agonist combinations.

Inhaled tiotropium is comarketed in the United States by Boehringer Ingelheim GmbH and Pfizer Inc. under the trade name Spiriva. Ipratropium is available generically and also is marketed by Boehringer Ingelheim as Atrovent.

In a statement, Pfizer and Boehringer Ingelheim said they “strongly disagree with the conclusion reached by Singh et al.,” and added that, “patients and physicians can be confident that Spiriva is a safe and effective medication.” The two companies released a new analysis of 30 controlled trials involving 19,545 patients with COPD. That analysis showed no increased risk of all-cause mortality, cardiac mortality, stroke, or MI (http://us.boehringeringelheim.com/newsroom/2008/09-23-08_spiriva_safety.html

The analysis includes unpublished data from the industry-sponsored UPLIFT (Understanding Potential Long-Term Impacts on Function With Tiotropium) trial, which were scheduled to be presented at a European Respiratory Society meeting in Berlin.

Earlier, Boehringer Ingelheim informed the Food and Drug Administration that ongoing safety monitoring had identified a “possible increased risk of stroke” in a safety analysis of 29 trials involving about 13,500 patients. That analysis estimated the risk of stroke was 8 patients/1,000 patients treated for 1 year with Spiriva, and 6 patients/1,000 per year for those treated with placebo (www.fda.gov/cder/drug/early_comm/tiotropium.htm

The investigators of the current meta-analysis acknowledged that the analysis was limited by the quality of reported data. Many of the trials analyzed were small and short term, resulting in few events.

“As a result of small numbers, the 95% [confidence intervals] are wide, resulting in some uncertainty as to the precise magnitude of the observed risk,” Dr. Singh and associates wrote. “None of these trials was specifically designed to monitor the risk of cardiovascular events, which were not adjudicated.”

A sensitivity analysis restricted to the five long-term studies (ranging from 48 weeks to 5 years) involving 7,267 patients confirmed the significantly increased risk of cardiovascular death, MI, and stroke (2.9% vs. 1.8% for controls; RR 1.73). However, there was no statistically significant increase in these events in a sensitivity analysis of the 12 short-term trials (ranging from 6 weeks to 26 weeks) involving 7,516 patients (0.6% vs. 0.6%; RR 1.16).

Dr. Singh and coauthor Dr. Yoon K. Loke of the University of East Anglia (England), Norwich, called for prospective, adequately powered trials with adjudication of cardiovascular events to assess the safety of inhaled anticholinergics in patients with COPD. The authors reported no financial disclosures.