Pulmonary Health Hub

Two "pragmatic" studies of leukotriene receptor antagonists in real-world asthma patients fell just short of demonstrating the drugs’ equivalence with inhaled glucocorticoids as first-line therapy and with beta-agonists as add-on therapy for exacerbations, according to a report in the May 5 issue of the New England Journal of Medicine.

Leukotriene receptor antagonists (LTRAs) met the criteria for equivalence to the other medications at 2-month follow-up, a time point that "represents a standard efficacy period" in most clinical trials. But LTRAs fell just shy of meeting the criteria for equivalence at 2-year follow-up, and that was the primary outcome measure for both studies, said Dr. David Price of the University of Aberdeen (Scotland) and his associates.

Despite this negative finding, "our [results] suggest that there is little difference in real-world effectiveness between an LTRA and an inhaled glucocorticoid as first-line controller therapy and between an LTRA and a long-acting beta-agonist as an add-on to an inhaled glucocorticoid," they said.

"Caution is needed in interpreting the results of these pragmatic trials," they noted.

In a perspective piece accompanying Dr. Price’s report, James H. Ware, Ph.D., and Dr. Mary Beth Hamel agreed, citing the "many challenges" involved in conducting pragmatic trials and interpreting their findings (N. Engl. J. Med. 2011;364:1685-7).

But "despite the trials’ limitations, the data provide encouraging evidence of equivalence or near-equivalence of the treatment strategies over the course of 2 years. Though imperfect, they provide helpful guidance for clinical care," said Dr. Ware, professor of biostatistics at Harvard School of Public Health, Boston, and a statistical consultant to the New England Journal of Medicine, and Dr. Hamel, also of Harvard and a deputy editor of the journal.

The two studies, conducted in parallel at 53 primary care practices throughout the United Kingdom, were funded primarily by the U.K. Health Technology Assessment Programme "for the explicit purpose of informing guidelines for asthma management in the British National Health Service," Dr. Ware and Dr. Hamel noted.

Both studies were unblinded and sought to enroll a broad spectrum of asthma patients aged 12-80 years, so as to reflect the complexity and diversity of routine clinical practice. However, because the studies ended up with very few subjects younger than 25 years of age, "our findings apply only to adults," Dr. Price and his colleagues said.

In the first study, 306 patients were randomly assigned to open-label treatment with either an LTRA (montelukast or zafirlukast) or an inhaled glucocorticoid (beclomethasone, budesonide, or fluticasone) as first-line therapy. Mean scores on the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) were equivalent between the two groups at 2 months, as were secondary end points of the frequency of exacerbations and mean scores on the Asthma Control Questionnaire, the Royal College of Physicians three-item questionnaire (RCP3), and the Mini Rhinoconjunctivitis Quality of Life Questionnaire.

All these secondary end points also were equivalent at 2-year follow-up. But mean scores on the MiniAQLQ did not meet the prespecified criteria for equivalence at 2 years.

In the second study, 352 patients whose asthma was not well controlled with inhaled glucocorticoids were randomly assigned to open-label add-on treatment with either an LTRA or a long-acting beta-agonist. Again, mean scores on the MiniAQLQ demonstrated equivalence of the two medications at 2 months, as did all the secondary end points at both 2 months and 2 years.

But again, the primary end point of mean scores on the MiniAQLQ at 2 years fell just outside the prespecified criteria for equivalence.

These results "suggest that an LTRA is equivalent to both comparison drugs with regard to the effect on asthma-related quality of life at 2 months in a diverse patient population with asthma," the investigators said (N. Engl. J. Med. 2011;364:1695-707).

However, they also "suggest that caution should be applied in extrapolating results from randomized clinical trials to the broad population of patients with asthma who are treated in community settings."

In both of these trials, leukotriene receptor antagonists were "essentially equivalent" in efficacy – findings that challenge current guidelines that favor inhaled glucocorticoids, according to Dr. Sven-Erik Dahlen and Dr. Barbro Dahlen of the Karolinska Institutet, Stockholm, and Dr. Jeffrey M. Drazen, editor in chief of the New England Journal of Medicine.

"The data reported by Price et al. send an important message to both the family doctor and the hospital specialist," they said in an editorial (N. Engl. J. Med. 2011;364:1769-70) accompanying Dr. Price’s report.

"Oral leukotriene modifiers provide an alternative treatment that may help patients pursue their activities of daily life as effectively as inhaled glucocorticoids do."

They added, "We think this alternative approach works in the real-world setting primarily because it is easier to take a pill once or twice a day than to use an inhaler. The data from the two studies support this view, since the rates of adherence to the oral LTRAs were 65% and 74% in the first-line controller and add-on therapy trials, respectively, compared with only 41% and 46% for the inhaled glucocorticoid."

This study was supported primarily by the U.K. Health Technology Assessment Programme. Additional funding for the study was provided by Clement Clarke International, Merck Sharp & Dohme, AstraZeneca, and Research in Real Life. Dr. Price and his associates reported numerous ties to industry sources. Dr. Ware and Dr. Hamel reported no conflicts of interest. Dr. Sven-Erik Dahlen reported ties to Regeneron Pharmaceuticals and GlaxoSmithKline, and Dr. Barbro Dahlen reported ties to Actelion and Genentech.

Two "pragmatic" studies of leukotriene receptor antagonists in real-world asthma patients fell just short of demonstrating the drugs’ equivalence with inhaled glucocorticoids as first-line therapy and with beta-agonists as add-on therapy for exacerbations, according to a report in the May 5 issue of the New England Journal of Medicine.

Leukotriene receptor antagonists (LTRAs) met the criteria for equivalence to the other medications at 2-month follow-up, a time point that "represents a standard efficacy period" in most clinical trials. But LTRAs fell just shy of meeting the criteria for equivalence at 2-year follow-up, and that was the primary outcome measure for both studies, said Dr. David Price of the University of Aberdeen (Scotland) and his associates.

Despite this negative finding, "our [results] suggest that there is little difference in real-world effectiveness between an LTRA and an inhaled glucocorticoid as first-line controller therapy and between an LTRA and a long-acting beta-agonist as an add-on to an inhaled glucocorticoid," they said.

"Caution is needed in interpreting the results of these pragmatic trials," they noted.

In a perspective piece accompanying Dr. Price’s report, James H. Ware, Ph.D., and Dr. Mary Beth Hamel agreed, citing the "many challenges" involved in conducting pragmatic trials and interpreting their findings (N. Engl. J. Med. 2011;364:1685-7).

But "despite the trials’ limitations, the data provide encouraging evidence of equivalence or near-equivalence of the treatment strategies over the course of 2 years. Though imperfect, they provide helpful guidance for clinical care," said Dr. Ware, professor of biostatistics at Harvard School of Public Health, Boston, and a statistical consultant to the New England Journal of Medicine, and Dr. Hamel, also of Harvard and a deputy editor of the journal.

The two studies, conducted in parallel at 53 primary care practices throughout the United Kingdom, were funded primarily by the U.K. Health Technology Assessment Programme "for the explicit purpose of informing guidelines for asthma management in the British National Health Service," Dr. Ware and Dr. Hamel noted.

Both studies were unblinded and sought to enroll a broad spectrum of asthma patients aged 12-80 years, so as to reflect the complexity and diversity of routine clinical practice. However, because the studies ended up with very few subjects younger than 25 years of age, "our findings apply only to adults," Dr. Price and his colleagues said.

In the first study, 306 patients were randomly assigned to open-label treatment with either an LTRA (montelukast or zafirlukast) or an inhaled glucocorticoid (beclomethasone, budesonide, or fluticasone) as first-line therapy. Mean scores on the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) were equivalent between the two groups at 2 months, as were secondary end points of the frequency of exacerbations and mean scores on the Asthma Control Questionnaire, the Royal College of Physicians three-item questionnaire (RCP3), and the Mini Rhinoconjunctivitis Quality of Life Questionnaire.

All these secondary end points also were equivalent at 2-year follow-up. But mean scores on the MiniAQLQ did not meet the prespecified criteria for equivalence at 2 years.

In the second study, 352 patients whose asthma was not well controlled with inhaled glucocorticoids were randomly assigned to open-label add-on treatment with either an LTRA or a long-acting beta-agonist. Again, mean scores on the MiniAQLQ demonstrated equivalence of the two medications at 2 months, as did all the secondary end points at both 2 months and 2 years.

But again, the primary end point of mean scores on the MiniAQLQ at 2 years fell just outside the prespecified criteria for equivalence.

These results "suggest that an LTRA is equivalent to both comparison drugs with regard to the effect on asthma-related quality of life at 2 months in a diverse patient population with asthma," the investigators said (N. Engl. J. Med. 2011;364:1695-707).

However, they also "suggest that caution should be applied in extrapolating results from randomized clinical trials to the broad population of patients with asthma who are treated in community settings."

In both of these trials, leukotriene receptor antagonists were "essentially equivalent" in efficacy – findings that challenge current guidelines that favor inhaled glucocorticoids, according to Dr. Sven-Erik Dahlen and Dr. Barbro Dahlen of the Karolinska Institutet, Stockholm, and Dr. Jeffrey M. Drazen, editor in chief of the New England Journal of Medicine.

"The data reported by Price et al. send an important message to both the family doctor and the hospital specialist," they said in an editorial (N. Engl. J. Med. 2011;364:1769-70) accompanying Dr. Price’s report.

"Oral leukotriene modifiers provide an alternative treatment that may help patients pursue their activities of daily life as effectively as inhaled glucocorticoids do."

They added, "We think this alternative approach works in the real-world setting primarily because it is easier to take a pill once or twice a day than to use an inhaler. The data from the two studies support this view, since the rates of adherence to the oral LTRAs were 65% and 74% in the first-line controller and add-on therapy trials, respectively, compared with only 41% and 46% for the inhaled glucocorticoid."

This study was supported primarily by the U.K. Health Technology Assessment Programme. Additional funding for the study was provided by Clement Clarke International, Merck Sharp & Dohme, AstraZeneca, and Research in Real Life. Dr. Price and his associates reported numerous ties to industry sources. Dr. Ware and Dr. Hamel reported no conflicts of interest. Dr. Sven-Erik Dahlen reported ties to Regeneron Pharmaceuticals and GlaxoSmithKline, and Dr. Barbro Dahlen reported ties to Actelion and Genentech.

Two "pragmatic" studies of leukotriene receptor antagonists in real-world asthma patients fell just short of demonstrating the drugs’ equivalence with inhaled glucocorticoids as first-line therapy and with beta-agonists as add-on therapy for exacerbations, according to a report in the May 5 issue of the New England Journal of Medicine.

Leukotriene receptor antagonists (LTRAs) met the criteria for equivalence to the other medications at 2-month follow-up, a time point that "represents a standard efficacy period" in most clinical trials. But LTRAs fell just shy of meeting the criteria for equivalence at 2-year follow-up, and that was the primary outcome measure for both studies, said Dr. David Price of the University of Aberdeen (Scotland) and his associates.

Despite this negative finding, "our [results] suggest that there is little difference in real-world effectiveness between an LTRA and an inhaled glucocorticoid as first-line controller therapy and between an LTRA and a long-acting beta-agonist as an add-on to an inhaled glucocorticoid," they said.

"Caution is needed in interpreting the results of these pragmatic trials," they noted.

In a perspective piece accompanying Dr. Price’s report, James H. Ware, Ph.D., and Dr. Mary Beth Hamel agreed, citing the "many challenges" involved in conducting pragmatic trials and interpreting their findings (N. Engl. J. Med. 2011;364:1685-7).

But "despite the trials’ limitations, the data provide encouraging evidence of equivalence or near-equivalence of the treatment strategies over the course of 2 years. Though imperfect, they provide helpful guidance for clinical care," said Dr. Ware, professor of biostatistics at Harvard School of Public Health, Boston, and a statistical consultant to the New England Journal of Medicine, and Dr. Hamel, also of Harvard and a deputy editor of the journal.

The two studies, conducted in parallel at 53 primary care practices throughout the United Kingdom, were funded primarily by the U.K. Health Technology Assessment Programme "for the explicit purpose of informing guidelines for asthma management in the British National Health Service," Dr. Ware and Dr. Hamel noted.

Both studies were unblinded and sought to enroll a broad spectrum of asthma patients aged 12-80 years, so as to reflect the complexity and diversity of routine clinical practice. However, because the studies ended up with very few subjects younger than 25 years of age, "our findings apply only to adults," Dr. Price and his colleagues said.

In the first study, 306 patients were randomly assigned to open-label treatment with either an LTRA (montelukast or zafirlukast) or an inhaled glucocorticoid (beclomethasone, budesonide, or fluticasone) as first-line therapy. Mean scores on the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) were equivalent between the two groups at 2 months, as were secondary end points of the frequency of exacerbations and mean scores on the Asthma Control Questionnaire, the Royal College of Physicians three-item questionnaire (RCP3), and the Mini Rhinoconjunctivitis Quality of Life Questionnaire.

All these secondary end points also were equivalent at 2-year follow-up. But mean scores on the MiniAQLQ did not meet the prespecified criteria for equivalence at 2 years.

In the second study, 352 patients whose asthma was not well controlled with inhaled glucocorticoids were randomly assigned to open-label add-on treatment with either an LTRA or a long-acting beta-agonist. Again, mean scores on the MiniAQLQ demonstrated equivalence of the two medications at 2 months, as did all the secondary end points at both 2 months and 2 years.

But again, the primary end point of mean scores on the MiniAQLQ at 2 years fell just outside the prespecified criteria for equivalence.

These results "suggest that an LTRA is equivalent to both comparison drugs with regard to the effect on asthma-related quality of life at 2 months in a diverse patient population with asthma," the investigators said (N. Engl. J. Med. 2011;364:1695-707).

However, they also "suggest that caution should be applied in extrapolating results from randomized clinical trials to the broad population of patients with asthma who are treated in community settings."

In both of these trials, leukotriene receptor antagonists were "essentially equivalent" in efficacy – findings that challenge current guidelines that favor inhaled glucocorticoids, according to Dr. Sven-Erik Dahlen and Dr. Barbro Dahlen of the Karolinska Institutet, Stockholm, and Dr. Jeffrey M. Drazen, editor in chief of the New England Journal of Medicine.

"The data reported by Price et al. send an important message to both the family doctor and the hospital specialist," they said in an editorial (N. Engl. J. Med. 2011;364:1769-70) accompanying Dr. Price’s report.

"Oral leukotriene modifiers provide an alternative treatment that may help patients pursue their activities of daily life as effectively as inhaled glucocorticoids do."

They added, "We think this alternative approach works in the real-world setting primarily because it is easier to take a pill once or twice a day than to use an inhaler. The data from the two studies support this view, since the rates of adherence to the oral LTRAs were 65% and 74% in the first-line controller and add-on therapy trials, respectively, compared with only 41% and 46% for the inhaled glucocorticoid."

This study was supported primarily by the U.K. Health Technology Assessment Programme. Additional funding for the study was provided by Clement Clarke International, Merck Sharp & Dohme, AstraZeneca, and Research in Real Life. Dr. Price and his associates reported numerous ties to industry sources. Dr. Ware and Dr. Hamel reported no conflicts of interest. Dr. Sven-Erik Dahlen reported ties to Regeneron Pharmaceuticals and GlaxoSmithKline, and Dr. Barbro Dahlen reported ties to Actelion and Genentech.

Two "pragmatic" studies of leukotriene receptor antagonists in real-world asthma patients fell just short of demonstrating the drugs’ equivalence with inhaled glucocorticoids as first-line therapy and with beta-agonists as add-on therapy for exacerbations, according to a report in the May 5 issue of the New England Journal of Medicine.

Leukotriene receptor antagonists (LTRAs) met the criteria for equivalence to the other medications at 2-month follow-up, a time point that "represents a standard efficacy period" in most clinical trials. But LTRAs fell just shy of meeting the criteria for equivalence at 2-year follow-up, and that was the primary outcome measure for both studies, said Dr. David Price of the University of Aberdeen (Scotland) and his associates.

Despite this negative finding, "our [results] suggest that there is little difference in real-world effectiveness between an LTRA and an inhaled glucocorticoid as first-line controller therapy and between an LTRA and a long-acting beta-agonist as an add-on to an inhaled glucocorticoid," they said.

"Caution is needed in interpreting the results of these pragmatic trials," they noted.

In a perspective piece accompanying Dr. Price’s report, James H. Ware, Ph.D., and Dr. Mary Beth Hamel agreed, citing the "many challenges" involved in conducting pragmatic trials and interpreting their findings (N. Engl. J. Med. 2011;364:1685-7).

But "despite the trials’ limitations, the data provide encouraging evidence of equivalence or near-equivalence of the treatment strategies over the course of 2 years. Though imperfect, they provide helpful guidance for clinical care," said Dr. Ware, professor of biostatistics at Harvard School of Public Health, Boston, and a statistical consultant to the New England Journal of Medicine, and Dr. Hamel, also of Harvard and a deputy editor of the journal.

The two studies, conducted in parallel at 53 primary care practices throughout the United Kingdom, were funded primarily by the U.K. Health Technology Assessment Programme "for the explicit purpose of informing guidelines for asthma management in the British National Health Service," Dr. Ware and Dr. Hamel noted.

Both studies were unblinded and sought to enroll a broad spectrum of asthma patients aged 12-80 years, so as to reflect the complexity and diversity of routine clinical practice. However, because the studies ended up with very few subjects younger than 25 years of age, "our findings apply only to adults," Dr. Price and his colleagues said.

In the first study, 306 patients were randomly assigned to open-label treatment with either an LTRA (montelukast or zafirlukast) or an inhaled glucocorticoid (beclomethasone, budesonide, or fluticasone) as first-line therapy. Mean scores on the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) were equivalent between the two groups at 2 months, as were secondary end points of the frequency of exacerbations and mean scores on the Asthma Control Questionnaire, the Royal College of Physicians three-item questionnaire (RCP3), and the Mini Rhinoconjunctivitis Quality of Life Questionnaire.

All these secondary end points also were equivalent at 2-year follow-up. But mean scores on the MiniAQLQ did not meet the prespecified criteria for equivalence at 2 years.

In the second study, 352 patients whose asthma was not well controlled with inhaled glucocorticoids were randomly assigned to open-label add-on treatment with either an LTRA or a long-acting beta-agonist. Again, mean scores on the MiniAQLQ demonstrated equivalence of the two medications at 2 months, as did all the secondary end points at both 2 months and 2 years.

But again, the primary end point of mean scores on the MiniAQLQ at 2 years fell just outside the prespecified criteria for equivalence.

These results "suggest that an LTRA is equivalent to both comparison drugs with regard to the effect on asthma-related quality of life at 2 months in a diverse patient population with asthma," the investigators said (N. Engl. J. Med. 2011;364:1695-707).

However, they also "suggest that caution should be applied in extrapolating results from randomized clinical trials to the broad population of patients with asthma who are treated in community settings."

In both of these trials, leukotriene receptor antagonists were "essentially equivalent" in efficacy – findings that challenge current guidelines that favor inhaled glucocorticoids, according to Dr. Sven-Erik Dahlen and Dr. Barbro Dahlen of the Karolinska Institutet, Stockholm, and Dr. Jeffrey M. Drazen, editor in chief of the New England Journal of Medicine.

"The data reported by Price et al. send an important message to both the family doctor and the hospital specialist," they said in an editorial (N. Engl. J. Med. 2011;364:1769-70) accompanying Dr. Price’s report.

"Oral leukotriene modifiers provide an alternative treatment that may help patients pursue their activities of daily life as effectively as inhaled glucocorticoids do."

They added, "We think this alternative approach works in the real-world setting primarily because it is easier to take a pill once or twice a day than to use an inhaler. The data from the two studies support this view, since the rates of adherence to the oral LTRAs were 65% and 74% in the first-line controller and add-on therapy trials, respectively, compared with only 41% and 46% for the inhaled glucocorticoid."

This study was supported primarily by the U.K. Health Technology Assessment Programme. Additional funding for the study was provided by Clement Clarke International, Merck Sharp & Dohme, AstraZeneca, and Research in Real Life. Dr. Price and his associates reported numerous ties to industry sources. Dr. Ware and Dr. Hamel reported no conflicts of interest. Dr. Sven-Erik Dahlen reported ties to Regeneron Pharmaceuticals and GlaxoSmithKline, and Dr. Barbro Dahlen reported ties to Actelion and Genentech.

Two "pragmatic" studies of leukotriene receptor antagonists in real-world asthma patients fell just short of demonstrating the drugs’ equivalence with inhaled glucocorticoids as first-line therapy and with beta-agonists as add-on therapy for exacerbations, according to a report in the May 5 issue of the New England Journal of Medicine.

Leukotriene receptor antagonists (LTRAs) met the criteria for equivalence to the other medications at 2-month follow-up, a time point that "represents a standard efficacy period" in most clinical trials. But LTRAs fell just shy of meeting the criteria for equivalence at 2-year follow-up, and that was the primary outcome measure for both studies, said Dr. David Price of the University of Aberdeen (Scotland) and his associates.

Despite this negative finding, "our [results] suggest that there is little difference in real-world effectiveness between an LTRA and an inhaled glucocorticoid as first-line controller therapy and between an LTRA and a long-acting beta-agonist as an add-on to an inhaled glucocorticoid," they said.

"Caution is needed in interpreting the results of these pragmatic trials," they noted.

In a perspective piece accompanying Dr. Price’s report, James H. Ware, Ph.D., and Dr. Mary Beth Hamel agreed, citing the "many challenges" involved in conducting pragmatic trials and interpreting their findings (N. Engl. J. Med. 2011;364:1685-7).

But "despite the trials’ limitations, the data provide encouraging evidence of equivalence or near-equivalence of the treatment strategies over the course of 2 years. Though imperfect, they provide helpful guidance for clinical care," said Dr. Ware, professor of biostatistics at Harvard School of Public Health, Boston, and a statistical consultant to the New England Journal of Medicine, and Dr. Hamel, also of Harvard and a deputy editor of the journal.

The two studies, conducted in parallel at 53 primary care practices throughout the United Kingdom, were funded primarily by the U.K. Health Technology Assessment Programme "for the explicit purpose of informing guidelines for asthma management in the British National Health Service," Dr. Ware and Dr. Hamel noted.

Both studies were unblinded and sought to enroll a broad spectrum of asthma patients aged 12-80 years, so as to reflect the complexity and diversity of routine clinical practice. However, because the studies ended up with very few subjects younger than 25 years of age, "our findings apply only to adults," Dr. Price and his colleagues said.

In the first study, 306 patients were randomly assigned to open-label treatment with either an LTRA (montelukast or zafirlukast) or an inhaled glucocorticoid (beclomethasone, budesonide, or fluticasone) as first-line therapy. Mean scores on the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) were equivalent between the two groups at 2 months, as were secondary end points of the frequency of exacerbations and mean scores on the Asthma Control Questionnaire, the Royal College of Physicians three-item questionnaire (RCP3), and the Mini Rhinoconjunctivitis Quality of Life Questionnaire.

All these secondary end points also were equivalent at 2-year follow-up. But mean scores on the MiniAQLQ did not meet the prespecified criteria for equivalence at 2 years.

In the second study, 352 patients whose asthma was not well controlled with inhaled glucocorticoids were randomly assigned to open-label add-on treatment with either an LTRA or a long-acting beta-agonist. Again, mean scores on the MiniAQLQ demonstrated equivalence of the two medications at 2 months, as did all the secondary end points at both 2 months and 2 years.

But again, the primary end point of mean scores on the MiniAQLQ at 2 years fell just outside the prespecified criteria for equivalence.

These results "suggest that an LTRA is equivalent to both comparison drugs with regard to the effect on asthma-related quality of life at 2 months in a diverse patient population with asthma," the investigators said (N. Engl. J. Med. 2011;364:1695-707).

However, they also "suggest that caution should be applied in extrapolating results from randomized clinical trials to the broad population of patients with asthma who are treated in community settings."

In both of these trials, leukotriene receptor antagonists were "essentially equivalent" in efficacy – findings that challenge current guidelines that favor inhaled glucocorticoids, according to Dr. Sven-Erik Dahlen and Dr. Barbro Dahlen of the Karolinska Institutet, Stockholm, and Dr. Jeffrey M. Drazen, editor in chief of the New England Journal of Medicine.

"The data reported by Price et al. send an important message to both the family doctor and the hospital specialist," they said in an editorial (N. Engl. J. Med. 2011;364:1769-70) accompanying Dr. Price’s report.

"Oral leukotriene modifiers provide an alternative treatment that may help patients pursue their activities of daily life as effectively as inhaled glucocorticoids do."

They added, "We think this alternative approach works in the real-world setting primarily because it is easier to take a pill once or twice a day than to use an inhaler. The data from the two studies support this view, since the rates of adherence to the oral LTRAs were 65% and 74% in the first-line controller and add-on therapy trials, respectively, compared with only 41% and 46% for the inhaled glucocorticoid."

This study was supported primarily by the U.K. Health Technology Assessment Programme. Additional funding for the study was provided by Clement Clarke International, Merck Sharp & Dohme, AstraZeneca, and Research in Real Life. Dr. Price and his associates reported numerous ties to industry sources. Dr. Ware and Dr. Hamel reported no conflicts of interest. Dr. Sven-Erik Dahlen reported ties to Regeneron Pharmaceuticals and GlaxoSmithKline, and Dr. Barbro Dahlen reported ties to Actelion and Genentech.

Two "pragmatic" studies of leukotriene receptor antagonists in real-world asthma patients fell just short of demonstrating the drugs’ equivalence with inhaled glucocorticoids as first-line therapy and with beta-agonists as add-on therapy for exacerbations, according to a report in the May 5 issue of the New England Journal of Medicine.

Leukotriene receptor antagonists (LTRAs) met the criteria for equivalence to the other medications at 2-month follow-up, a time point that "represents a standard efficacy period" in most clinical trials. But LTRAs fell just shy of meeting the criteria for equivalence at 2-year follow-up, and that was the primary outcome measure for both studies, said Dr. David Price of the University of Aberdeen (Scotland) and his associates.

Despite this negative finding, "our [results] suggest that there is little difference in real-world effectiveness between an LTRA and an inhaled glucocorticoid as first-line controller therapy and between an LTRA and a long-acting beta-agonist as an add-on to an inhaled glucocorticoid," they said.

"Caution is needed in interpreting the results of these pragmatic trials," they noted.

In a perspective piece accompanying Dr. Price’s report, James H. Ware, Ph.D., and Dr. Mary Beth Hamel agreed, citing the "many challenges" involved in conducting pragmatic trials and interpreting their findings (N. Engl. J. Med. 2011;364:1685-7).

But "despite the trials’ limitations, the data provide encouraging evidence of equivalence or near-equivalence of the treatment strategies over the course of 2 years. Though imperfect, they provide helpful guidance for clinical care," said Dr. Ware, professor of biostatistics at Harvard School of Public Health, Boston, and a statistical consultant to the New England Journal of Medicine, and Dr. Hamel, also of Harvard and a deputy editor of the journal.

The two studies, conducted in parallel at 53 primary care practices throughout the United Kingdom, were funded primarily by the U.K. Health Technology Assessment Programme "for the explicit purpose of informing guidelines for asthma management in the British National Health Service," Dr. Ware and Dr. Hamel noted.

Both studies were unblinded and sought to enroll a broad spectrum of asthma patients aged 12-80 years, so as to reflect the complexity and diversity of routine clinical practice. However, because the studies ended up with very few subjects younger than 25 years of age, "our findings apply only to adults," Dr. Price and his colleagues said.

In the first study, 306 patients were randomly assigned to open-label treatment with either an LTRA (montelukast or zafirlukast) or an inhaled glucocorticoid (beclomethasone, budesonide, or fluticasone) as first-line therapy. Mean scores on the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) were equivalent between the two groups at 2 months, as were secondary end points of the frequency of exacerbations and mean scores on the Asthma Control Questionnaire, the Royal College of Physicians three-item questionnaire (RCP3), and the Mini Rhinoconjunctivitis Quality of Life Questionnaire.

All these secondary end points also were equivalent at 2-year follow-up. But mean scores on the MiniAQLQ did not meet the prespecified criteria for equivalence at 2 years.

In the second study, 352 patients whose asthma was not well controlled with inhaled glucocorticoids were randomly assigned to open-label add-on treatment with either an LTRA or a long-acting beta-agonist. Again, mean scores on the MiniAQLQ demonstrated equivalence of the two medications at 2 months, as did all the secondary end points at both 2 months and 2 years.

But again, the primary end point of mean scores on the MiniAQLQ at 2 years fell just outside the prespecified criteria for equivalence.

These results "suggest that an LTRA is equivalent to both comparison drugs with regard to the effect on asthma-related quality of life at 2 months in a diverse patient population with asthma," the investigators said (N. Engl. J. Med. 2011;364:1695-707).

However, they also "suggest that caution should be applied in extrapolating results from randomized clinical trials to the broad population of patients with asthma who are treated in community settings."

In both of these trials, leukotriene receptor antagonists were "essentially equivalent" in efficacy – findings that challenge current guidelines that favor inhaled glucocorticoids, according to Dr. Sven-Erik Dahlen and Dr. Barbro Dahlen of the Karolinska Institutet, Stockholm, and Dr. Jeffrey M. Drazen, editor in chief of the New England Journal of Medicine.

"The data reported by Price et al. send an important message to both the family doctor and the hospital specialist," they said in an editorial (N. Engl. J. Med. 2011;364:1769-70) accompanying Dr. Price’s report.

"Oral leukotriene modifiers provide an alternative treatment that may help patients pursue their activities of daily life as effectively as inhaled glucocorticoids do."

They added, "We think this alternative approach works in the real-world setting primarily because it is easier to take a pill once or twice a day than to use an inhaler. The data from the two studies support this view, since the rates of adherence to the oral LTRAs were 65% and 74% in the first-line controller and add-on therapy trials, respectively, compared with only 41% and 46% for the inhaled glucocorticoid."

This study was supported primarily by the U.K. Health Technology Assessment Programme. Additional funding for the study was provided by Clement Clarke International, Merck Sharp & Dohme, AstraZeneca, and Research in Real Life. Dr. Price and his associates reported numerous ties to industry sources. Dr. Ware and Dr. Hamel reported no conflicts of interest. Dr. Sven-Erik Dahlen reported ties to Regeneron Pharmaceuticals and GlaxoSmithKline, and Dr. Barbro Dahlen reported ties to Actelion and Genentech.

Despite national efforts to improve the quality of care and health outcomes of individuals with asthma, the overall prevalence of the chronic respiratory disease in the United States increased by more than 12% between 2001 and 2009, according to a report released May 3 by the Centers for Disease Control and Prevention.

Based on data from the 2001-2009 National Health Interview Survey and the 2001, 2005, and 2009 state-based Behavioral Risk Factor Surveillance System, the prevalence of asthma among people of all ages increased from 20.3 million (7.3%) in 2001 to 24.6 million (8.2%) in 2009, the agency reported in the May 3 issue of the Morbidity and Mortality Weekly Report. The prevalence among children younger than 18 years increased from 8.7% to 9.6% during this period, with the highest prevalence rates observed among poor children, at 13.5%; non-Hispanic black children, at 17.0%; and boys, at 11.3%. Among adults, asthma prevalence increased from 6.9% in 2001 to 7.7% in 2009, with the highest rates seen in poor adults (10.6%) and in women (9.7%), according to the report (MMWR 2011;60:1-7).

"Approximately 1 out of every 12 individuals in the United States has asthma, and the number is rising," said Ileana Arias, Ph.D., principal deputy director of the CDC. "The estimated total cost of asthma in terms of medical expenses, lost school or work days, and premature death was $56 billion in 2007," she said in a press briefing. Although the reasons for the increased prevalence of the condition are unclear, particularly in light of improvements that have been made in outdoor air quality and the reduction of two common asthma triggers (smoking and second-hand smoke), "we do know that there are measures that can be taken to control asthma symptoms to avoid exacerbations and many attacks, and health care providers, insurers, people with asthma, and others should work together to implement these measures," she said.

A review of the disease characteristics and self-management education status data for 2008 showed that "more than half [52.6%] of the people with asthma reported having an attack within the prior year. Nearly 42% missed 1 or more days of work or school because of their asthma, 26% visited the emergency department or urgent care center for treatment, and 7% were hospitalized," Paul Garbe, DVM, chief of the CDC’s Air Pollution and Respiratory Health Branch, said during the press briefing. "The estimated per person/per year medical expenses associated with asthma between 2002 and 2007 was $3,259."

Assessing gaps in health care coverage and access could alter the asthma landscape, Dr. Garbe said. "Of the nearly 90% of asthma patients with health insurance, approximately 12% reported not being able to afford their prescription medicine, 37% had ever seen or talked to a specialist physician about their asthma, and 86% had ever talked to a primary care provider about it," he said. Among the uninsured asthma population, 40% reportedly couldn’t afford medication, nearly 20% had seen or talked to an asthma specialist, and 60% had seen or talked to a primary care physician about their asthma.

Further, although it is well understood that optimal asthma control includes self-management training, appropriate use of inhaled corticosteroids, and avoidance of environmental allergens and irritants, only one-third of the population had ever been given an action plan as recommended by the National Institute of Health’s National Asthma Education and Prevention Program (NAEPP), Dr. Garbe said. An action plan, as defined by the NAEPP, is a written form developed by health care providers that addresses the asthma-related needs and circumstances of individual patients, including how to monitor symptoms, when to make medication changes, how to identify and avoid irritants and allergens, how to recognize worsening symptoms, and when to take action.

The CDC has worked with health departments in some states to develop and implement interventions based on the guidelines. In Connecticut, for example, "a program for in-home education and environmental assessment has been implemented in an effort to reduce the number of children and adults who rely on the emergency department as their primary source of health care," Dr. Garbe said. "Since the program began, there has been a dramatic reduction in the average number of emergency/urgent care visits for asthma, from approximately three in a 6-month period to fewer than one." Rhode Island and New York also have developed asthma education programs designed to reduce the human and economic costs of asthma, he said.

Although potentially limited by the fact that the databases from which the results were obtained are based on adult self-report or adult proxy responses for children and thus are vulnerable to recall bias, the findings do suggest that people with asthma are doing a suboptimal job of managing their symptoms and that coordinated efforts at the local, state, and national levels should target patient education. Evidence-based interventions to reduce environmental risk factors for asthma also are needed, Dr. Garbe said.

Dr. Arias and Dr. Garbe disclosed no financial conflicts of interest.

Despite national efforts to improve the quality of care and health outcomes of individuals with asthma, the overall prevalence of the chronic respiratory disease in the United States increased by more than 12% between 2001 and 2009, according to a report released May 3 by the Centers for Disease Control and Prevention.

Based on data from the 2001-2009 National Health Interview Survey and the 2001, 2005, and 2009 state-based Behavioral Risk Factor Surveillance System, the prevalence of asthma among people of all ages increased from 20.3 million (7.3%) in 2001 to 24.6 million (8.2%) in 2009, the agency reported in the May 3 issue of the Morbidity and Mortality Weekly Report. The prevalence among children younger than 18 years increased from 8.7% to 9.6% during this period, with the highest prevalence rates observed among poor children, at 13.5%; non-Hispanic black children, at 17.0%; and boys, at 11.3%. Among adults, asthma prevalence increased from 6.9% in 2001 to 7.7% in 2009, with the highest rates seen in poor adults (10.6%) and in women (9.7%), according to the report (MMWR 2011;60:1-7).

"Approximately 1 out of every 12 individuals in the United States has asthma, and the number is rising," said Ileana Arias, Ph.D., principal deputy director of the CDC. "The estimated total cost of asthma in terms of medical expenses, lost school or work days, and premature death was $56 billion in 2007," she said in a press briefing. Although the reasons for the increased prevalence of the condition are unclear, particularly in light of improvements that have been made in outdoor air quality and the reduction of two common asthma triggers (smoking and second-hand smoke), "we do know that there are measures that can be taken to control asthma symptoms to avoid exacerbations and many attacks, and health care providers, insurers, people with asthma, and others should work together to implement these measures," she said.

A review of the disease characteristics and self-management education status data for 2008 showed that "more than half [52.6%] of the people with asthma reported having an attack within the prior year. Nearly 42% missed 1 or more days of work or school because of their asthma, 26% visited the emergency department or urgent care center for treatment, and 7% were hospitalized," Paul Garbe, DVM, chief of the CDC’s Air Pollution and Respiratory Health Branch, said during the press briefing. "The estimated per person/per year medical expenses associated with asthma between 2002 and 2007 was $3,259."

Assessing gaps in health care coverage and access could alter the asthma landscape, Dr. Garbe said. "Of the nearly 90% of asthma patients with health insurance, approximately 12% reported not being able to afford their prescription medicine, 37% had ever seen or talked to a specialist physician about their asthma, and 86% had ever talked to a primary care provider about it," he said. Among the uninsured asthma population, 40% reportedly couldn’t afford medication, nearly 20% had seen or talked to an asthma specialist, and 60% had seen or talked to a primary care physician about their asthma.

Further, although it is well understood that optimal asthma control includes self-management training, appropriate use of inhaled corticosteroids, and avoidance of environmental allergens and irritants, only one-third of the population had ever been given an action plan as recommended by the National Institute of Health’s National Asthma Education and Prevention Program (NAEPP), Dr. Garbe said. An action plan, as defined by the NAEPP, is a written form developed by health care providers that addresses the asthma-related needs and circumstances of individual patients, including how to monitor symptoms, when to make medication changes, how to identify and avoid irritants and allergens, how to recognize worsening symptoms, and when to take action.

The CDC has worked with health departments in some states to develop and implement interventions based on the guidelines. In Connecticut, for example, "a program for in-home education and environmental assessment has been implemented in an effort to reduce the number of children and adults who rely on the emergency department as their primary source of health care," Dr. Garbe said. "Since the program began, there has been a dramatic reduction in the average number of emergency/urgent care visits for asthma, from approximately three in a 6-month period to fewer than one." Rhode Island and New York also have developed asthma education programs designed to reduce the human and economic costs of asthma, he said.

Although potentially limited by the fact that the databases from which the results were obtained are based on adult self-report or adult proxy responses for children and thus are vulnerable to recall bias, the findings do suggest that people with asthma are doing a suboptimal job of managing their symptoms and that coordinated efforts at the local, state, and national levels should target patient education. Evidence-based interventions to reduce environmental risk factors for asthma also are needed, Dr. Garbe said.

Dr. Arias and Dr. Garbe disclosed no financial conflicts of interest.

Despite national efforts to improve the quality of care and health outcomes of individuals with asthma, the overall prevalence of the chronic respiratory disease in the United States increased by more than 12% between 2001 and 2009, according to a report released May 3 by the Centers for Disease Control and Prevention.

Based on data from the 2001-2009 National Health Interview Survey and the 2001, 2005, and 2009 state-based Behavioral Risk Factor Surveillance System, the prevalence of asthma among people of all ages increased from 20.3 million (7.3%) in 2001 to 24.6 million (8.2%) in 2009, the agency reported in the May 3 issue of the Morbidity and Mortality Weekly Report. The prevalence among children younger than 18 years increased from 8.7% to 9.6% during this period, with the highest prevalence rates observed among poor children, at 13.5%; non-Hispanic black children, at 17.0%; and boys, at 11.3%. Among adults, asthma prevalence increased from 6.9% in 2001 to 7.7% in 2009, with the highest rates seen in poor adults (10.6%) and in women (9.7%), according to the report (MMWR 2011;60:1-7).

"Approximately 1 out of every 12 individuals in the United States has asthma, and the number is rising," said Ileana Arias, Ph.D., principal deputy director of the CDC. "The estimated total cost of asthma in terms of medical expenses, lost school or work days, and premature death was $56 billion in 2007," she said in a press briefing. Although the reasons for the increased prevalence of the condition are unclear, particularly in light of improvements that have been made in outdoor air quality and the reduction of two common asthma triggers (smoking and second-hand smoke), "we do know that there are measures that can be taken to control asthma symptoms to avoid exacerbations and many attacks, and health care providers, insurers, people with asthma, and others should work together to implement these measures," she said.

A review of the disease characteristics and self-management education status data for 2008 showed that "more than half [52.6%] of the people with asthma reported having an attack within the prior year. Nearly 42% missed 1 or more days of work or school because of their asthma, 26% visited the emergency department or urgent care center for treatment, and 7% were hospitalized," Paul Garbe, DVM, chief of the CDC’s Air Pollution and Respiratory Health Branch, said during the press briefing. "The estimated per person/per year medical expenses associated with asthma between 2002 and 2007 was $3,259."

Assessing gaps in health care coverage and access could alter the asthma landscape, Dr. Garbe said. "Of the nearly 90% of asthma patients with health insurance, approximately 12% reported not being able to afford their prescription medicine, 37% had ever seen or talked to a specialist physician about their asthma, and 86% had ever talked to a primary care provider about it," he said. Among the uninsured asthma population, 40% reportedly couldn’t afford medication, nearly 20% had seen or talked to an asthma specialist, and 60% had seen or talked to a primary care physician about their asthma.

Further, although it is well understood that optimal asthma control includes self-management training, appropriate use of inhaled corticosteroids, and avoidance of environmental allergens and irritants, only one-third of the population had ever been given an action plan as recommended by the National Institute of Health’s National Asthma Education and Prevention Program (NAEPP), Dr. Garbe said. An action plan, as defined by the NAEPP, is a written form developed by health care providers that addresses the asthma-related needs and circumstances of individual patients, including how to monitor symptoms, when to make medication changes, how to identify and avoid irritants and allergens, how to recognize worsening symptoms, and when to take action.

The CDC has worked with health departments in some states to develop and implement interventions based on the guidelines. In Connecticut, for example, "a program for in-home education and environmental assessment has been implemented in an effort to reduce the number of children and adults who rely on the emergency department as their primary source of health care," Dr. Garbe said. "Since the program began, there has been a dramatic reduction in the average number of emergency/urgent care visits for asthma, from approximately three in a 6-month period to fewer than one." Rhode Island and New York also have developed asthma education programs designed to reduce the human and economic costs of asthma, he said.

Although potentially limited by the fact that the databases from which the results were obtained are based on adult self-report or adult proxy responses for children and thus are vulnerable to recall bias, the findings do suggest that people with asthma are doing a suboptimal job of managing their symptoms and that coordinated efforts at the local, state, and national levels should target patient education. Evidence-based interventions to reduce environmental risk factors for asthma also are needed, Dr. Garbe said.

Dr. Arias and Dr. Garbe disclosed no financial conflicts of interest.

Despite national efforts to improve the quality of care and health outcomes of individuals with asthma, the overall prevalence of the chronic respiratory disease in the United States increased by more than 12% between 2001 and 2009, according to a report released May 3 by the Centers for Disease Control and Prevention.

Based on data from the 2001-2009 National Health Interview Survey and the 2001, 2005, and 2009 state-based Behavioral Risk Factor Surveillance System, the prevalence of asthma among people of all ages increased from 20.3 million (7.3%) in 2001 to 24.6 million (8.2%) in 2009, the agency reported in the May 3 issue of the Morbidity and Mortality Weekly Report. The prevalence among children younger than 18 years increased from 8.7% to 9.6% during this period, with the highest prevalence rates observed among poor children, at 13.5%; non-Hispanic black children, at 17.0%; and boys, at 11.3%. Among adults, asthma prevalence increased from 6.9% in 2001 to 7.7% in 2009, with the highest rates seen in poor adults (10.6%) and in women (9.7%), according to the report (MMWR 2011;60:1-7).

Photo credit: © Monkey Business/Fotolia.com

"Approximately 1 out of every 12 individuals in the United States has asthma, and the number is rising," said Ileana Arias, Ph.D., principal deputy director of the CDC. "The estimated total cost of asthma in terms of medical expenses, lost school or work days, and premature death was $56 billion in 2007," she said in a press briefing. Although the reasons for the increased prevalence of the condition are unclear, particularly in light of improvements that have been made in outdoor air quality and the reduction of two common asthma triggers (smoking and second-hand smoke), "we do know that there are measures that can be taken to control asthma symptoms to avoid exacerbations and many attacks, and health care providers, insurers, people with asthma, and others should work together to implement these measures," she said.

A review of the disease characteristics and self-management education status data for 2008 showed that "more than half [52.6%] of the people with asthma reported having an attack within the prior year. Nearly 42% missed 1 or more days of work or school because of their asthma, 26% visited the emergency department or urgent care center for treatment, and 7% were hospitalized," Paul Garbe, DVM, chief of the CDC’s Air Pollution and Respiratory Health Branch, said during the press briefing. "The estimated per person/per year medical expenses associated with asthma between 2002 and 2007 was $3,259."

Assessing gaps in health care coverage and access could alter the asthma landscape, Dr. Garbe said. "Of the nearly 90% of asthma patients with health insurance, approximately 12% reported not being able to afford their prescription medicine, 37% had ever seen or talked to a specialist physician about their asthma, and 86% had ever talked to a primary care provider about it," he said. Among the uninsured asthma population, 40% reportedly couldn’t afford medication, nearly 20% had seen or talked to an asthma specialist, and 60% had seen or talked to a primary care physician about their asthma.

Further, although it is well understood that optimal asthma control includes self-management training, appropriate use of inhaled corticosteroids, and avoidance of environmental allergens and irritants, only one-third of the population had ever been given an action plan as recommended by the National Institute of Health’s National Asthma Education and Prevention Program (NAEPP), Dr. Garbe said. An action plan, as defined by the NAEPP, is a written form developed by health care providers that addresses the asthma-related needs and circumstances of individual patients, including how to monitor symptoms, when to make medication changes, how to identify and avoid irritants and allergens, how to recognize worsening symptoms, and when to take action.

The CDC has worked with health departments in some states to develop and implement interventions based on the guidelines. In Connecticut, for example, "a program for in-home education and environmental assessment has been implemented in an effort to reduce the number of children and adults who rely on the emergency department as their primary source of health care," Dr. Garbe said. "Since the program began, there has been a dramatic reduction in the average number of emergency/urgent care visits for asthma, from approximately three in a 6-month period to fewer than one." Rhode Island and New York also have developed asthma education programs designed to reduce the human and economic costs of asthma, he said.

Although potentially limited by the fact that the databases from which the results were obtained are based on adult self-report or adult proxy responses for children and thus are vulnerable to recall bias, the findings do suggest that people with asthma are doing a suboptimal job of managing their symptoms and that coordinated efforts at the local, state, and national levels should target patient education. Evidence-based interventions to reduce environmental risk factors for asthma also are needed, Dr. Garbe said.

Dr. Arias and Dr. Garbe disclosed no financial conflicts of interest.

Despite national efforts to improve the quality of care and health outcomes of individuals with asthma, the overall prevalence of the chronic respiratory disease in the United States increased by more than 12% between 2001 and 2009, according to a report released May 3 by the Centers for Disease Control and Prevention.

Based on data from the 2001-2009 National Health Interview Survey and the 2001, 2005, and 2009 state-based Behavioral Risk Factor Surveillance System, the prevalence of asthma among people of all ages increased from 20.3 million (7.3%) in 2001 to 24.6 million (8.2%) in 2009, the agency reported in the May 3 issue of the Morbidity and Mortality Weekly Report. The prevalence among children younger than 18 years increased from 8.7% to 9.6% during this period, with the highest prevalence rates observed among poor children, at 13.5%; non-Hispanic black children, at 17.0%; and boys, at 11.3%. Among adults, asthma prevalence increased from 6.9% in 2001 to 7.7% in 2009, with the highest rates seen in poor adults (10.6%) and in women (9.7%), according to the report (MMWR 2011;60:1-7).

Photo credit: © Monkey Business/Fotolia.com

"Approximately 1 out of every 12 individuals in the United States has asthma, and the number is rising," said Ileana Arias, Ph.D., principal deputy director of the CDC. "The estimated total cost of asthma in terms of medical expenses, lost school or work days, and premature death was $56 billion in 2007," she said in a press briefing. Although the reasons for the increased prevalence of the condition are unclear, particularly in light of improvements that have been made in outdoor air quality and the reduction of two common asthma triggers (smoking and second-hand smoke), "we do know that there are measures that can be taken to control asthma symptoms to avoid exacerbations and many attacks, and health care providers, insurers, people with asthma, and others should work together to implement these measures," she said.

A review of the disease characteristics and self-management education status data for 2008 showed that "more than half [52.6%] of the people with asthma reported having an attack within the prior year. Nearly 42% missed 1 or more days of work or school because of their asthma, 26% visited the emergency department or urgent care center for treatment, and 7% were hospitalized," Paul Garbe, DVM, chief of the CDC’s Air Pollution and Respiratory Health Branch, said during the press briefing. "The estimated per person/per year medical expenses associated with asthma between 2002 and 2007 was $3,259."

Assessing gaps in health care coverage and access could alter the asthma landscape, Dr. Garbe said. "Of the nearly 90% of asthma patients with health insurance, approximately 12% reported not being able to afford their prescription medicine, 37% had ever seen or talked to a specialist physician about their asthma, and 86% had ever talked to a primary care provider about it," he said. Among the uninsured asthma population, 40% reportedly couldn’t afford medication, nearly 20% had seen or talked to an asthma specialist, and 60% had seen or talked to a primary care physician about their asthma.

Further, although it is well understood that optimal asthma control includes self-management training, appropriate use of inhaled corticosteroids, and avoidance of environmental allergens and irritants, only one-third of the population had ever been given an action plan as recommended by the National Institute of Health’s National Asthma Education and Prevention Program (NAEPP), Dr. Garbe said. An action plan, as defined by the NAEPP, is a written form developed by health care providers that addresses the asthma-related needs and circumstances of individual patients, including how to monitor symptoms, when to make medication changes, how to identify and avoid irritants and allergens, how to recognize worsening symptoms, and when to take action.

The CDC has worked with health departments in some states to develop and implement interventions based on the guidelines. In Connecticut, for example, "a program for in-home education and environmental assessment has been implemented in an effort to reduce the number of children and adults who rely on the emergency department as their primary source of health care," Dr. Garbe said. "Since the program began, there has been a dramatic reduction in the average number of emergency/urgent care visits for asthma, from approximately three in a 6-month period to fewer than one." Rhode Island and New York also have developed asthma education programs designed to reduce the human and economic costs of asthma, he said.

Although potentially limited by the fact that the databases from which the results were obtained are based on adult self-report or adult proxy responses for children and thus are vulnerable to recall bias, the findings do suggest that people with asthma are doing a suboptimal job of managing their symptoms and that coordinated efforts at the local, state, and national levels should target patient education. Evidence-based interventions to reduce environmental risk factors for asthma also are needed, Dr. Garbe said.

Dr. Arias and Dr. Garbe disclosed no financial conflicts of interest.

Despite national efforts to improve the quality of care and health outcomes of individuals with asthma, the overall prevalence of the chronic respiratory disease in the United States increased by more than 12% between 2001 and 2009, according to a report released May 3 by the Centers for Disease Control and Prevention.

Based on data from the 2001-2009 National Health Interview Survey and the 2001, 2005, and 2009 state-based Behavioral Risk Factor Surveillance System, the prevalence of asthma among people of all ages increased from 20.3 million (7.3%) in 2001 to 24.6 million (8.2%) in 2009, the agency reported in the May 3 issue of the Morbidity and Mortality Weekly Report. The prevalence among children younger than 18 years increased from 8.7% to 9.6% during this period, with the highest prevalence rates observed among poor children, at 13.5%; non-Hispanic black children, at 17.0%; and boys, at 11.3%. Among adults, asthma prevalence increased from 6.9% in 2001 to 7.7% in 2009, with the highest rates seen in poor adults (10.6%) and in women (9.7%), according to the report (MMWR 2011;60:1-7).

Photo credit: © Monkey Business/Fotolia.com

"Approximately 1 out of every 12 individuals in the United States has asthma, and the number is rising," said Ileana Arias, Ph.D., principal deputy director of the CDC. "The estimated total cost of asthma in terms of medical expenses, lost school or work days, and premature death was $56 billion in 2007," she said in a press briefing. Although the reasons for the increased prevalence of the condition are unclear, particularly in light of improvements that have been made in outdoor air quality and the reduction of two common asthma triggers (smoking and second-hand smoke), "we do know that there are measures that can be taken to control asthma symptoms to avoid exacerbations and many attacks, and health care providers, insurers, people with asthma, and others should work together to implement these measures," she said.

A review of the disease characteristics and self-management education status data for 2008 showed that "more than half [52.6%] of the people with asthma reported having an attack within the prior year. Nearly 42% missed 1 or more days of work or school because of their asthma, 26% visited the emergency department or urgent care center for treatment, and 7% were hospitalized," Paul Garbe, DVM, chief of the CDC’s Air Pollution and Respiratory Health Branch, said during the press briefing. "The estimated per person/per year medical expenses associated with asthma between 2002 and 2007 was $3,259."

Assessing gaps in health care coverage and access could alter the asthma landscape, Dr. Garbe said. "Of the nearly 90% of asthma patients with health insurance, approximately 12% reported not being able to afford their prescription medicine, 37% had ever seen or talked to a specialist physician about their asthma, and 86% had ever talked to a primary care provider about it," he said. Among the uninsured asthma population, 40% reportedly couldn’t afford medication, nearly 20% had seen or talked to an asthma specialist, and 60% had seen or talked to a primary care physician about their asthma.

Further, although it is well understood that optimal asthma control includes self-management training, appropriate use of inhaled corticosteroids, and avoidance of environmental allergens and irritants, only one-third of the population had ever been given an action plan as recommended by the National Institute of Health’s National Asthma Education and Prevention Program (NAEPP), Dr. Garbe said. An action plan, as defined by the NAEPP, is a written form developed by health care providers that addresses the asthma-related needs and circumstances of individual patients, including how to monitor symptoms, when to make medication changes, how to identify and avoid irritants and allergens, how to recognize worsening symptoms, and when to take action.

The CDC has worked with health departments in some states to develop and implement interventions based on the guidelines. In Connecticut, for example, "a program for in-home education and environmental assessment has been implemented in an effort to reduce the number of children and adults who rely on the emergency department as their primary source of health care," Dr. Garbe said. "Since the program began, there has been a dramatic reduction in the average number of emergency/urgent care visits for asthma, from approximately three in a 6-month period to fewer than one." Rhode Island and New York also have developed asthma education programs designed to reduce the human and economic costs of asthma, he said.

Although potentially limited by the fact that the databases from which the results were obtained are based on adult self-report or adult proxy responses for children and thus are vulnerable to recall bias, the findings do suggest that people with asthma are doing a suboptimal job of managing their symptoms and that coordinated efforts at the local, state, and national levels should target patient education. Evidence-based interventions to reduce environmental risk factors for asthma also are needed, Dr. Garbe said.

Dr. Arias and Dr. Garbe disclosed no financial conflicts of interest.

DENVER – Children exposed to secondhand tobacco smoke who are admitted to the hospital for influenza are more likely to require admission to the intensive care unit and have a longer hospital stay than their peers who are not exposed to secondhand smoke.

These effects are even greater for children with chronic illnesses who are exposed to secondhand smoke, Dr. Karen M. Wilson reported at the annual meeting of the Pediatric Academic Societies.

An estimated 18% of children aged 3-11 years are regularly exposed to secondhand tobacco smoke inside the home, said Dr. Wilson, assistant professor of pediatrics at the University of Rochester (N.Y.).

Although secondhand smoke exposure is associated with worse outcomes for children’s illnesses, including respiratory syncytial virus and asthma, "the effect of secondhand smoke exposure on influenza severity in children is unclear," she noted. "More than 40% of preschool children experience influenza at some point. In adults, tobacco smoke increases the risk of influenza infection and the risk of complications."

To determine if children hospitalized with influenza who are exposed to secondhand smoke have more severe illness, Dr. Wilson and her associates conducted a review of 169 medical charts at Golisano Children’s Hospital in Rochester. They generated a list of patients aged 0-15 years with a discharge diagnosis of influenza between 2002 and 2009. The influenza diagnosis was verified by laboratory review.

Measures of severity included intensive care unit admission, defined as admission or transfer to the ICU at any time during the stay; need for mechanical ventilation, defined as any documentation of endotracheal intubation during the stay; and length of stay.

Exposure to secondhand smoke was assessed by any documentation of presence or absence of secondhand smoke exposure by any provider. "Any documentation of exposure was considered exposed; documentation of no exposure was considered not exposed," Dr. Wilson said.

She reported findings from 113 children who were included in the final analysis. Of these, 46 (41%) were exposed to secondhand smoke and 67 (59%) were not. The average age of the 113 children was 4 years, and 50% were male. Of the 113 children, 58% were white, 22% were black, 8% were Hispanic, and 3.5% were Asian; race/ethnicity was unknown in the remaining 8.5%. Fewer than half of the children (44%) had public health insurance.

More than three-quarters of the children (78%) had influenza A. In addition, 25% had asthma, 25% had an underlying chronic condition, 14% had documentation of prematurity, 19% required ICU care, and 6% required mechanical ventilation.

None of the potential covariates – including asthma, prematurity, and chronic conditions – were significantly associated with secondhand smoke exposure. However, children exposed to secondhand smoke were significantly more likely to require ICU admission (31% vs. 10% for children with no exposure) and mechanical ventilation (13% vs. 2%, respectively).

The mean length of stay was 2.1 days for children who had no chronic condition or exposure to secondhand smoke, 2.5 days for children who had no chronic condition but had exposure to secondhand smoke, 3.5 days for children who had a chronic condition but no exposure to secondhand smoke, and 11 days for children who had a chronic condition and were exposed to secondhand smoke.

In a logistic regression model controlling for age, gender, race, and type of insurance, exposure to secondhand smoke was significantly associated with ICU admission but chronic conditions were not.

In a logistic regression model limited to exposure to secondhand smoke and chronic conditions, chronic conditions were associated with the need for mechanical ventilation but exposure to secondhand smoke was not.

In a negative binomial regression model using the log-transformed length of stay, controlling for age, gender, race, insurance type, and chronic conditions, exposure to secondhand smoke was associated with an increased length of hospital stay, with an incident rate ratio of 1.9.

Dr. Wilson acknowledged certain limitations of the study, including its single-center design "and the potential for errors in documentation and abstraction," she said. "The exposure measure was reliant on provider documentation ... but provider documentation is more likely to underestimate secondhand smoke exposure in children, so we probably misclassified some children as being non–smoke exposed."

In addition, "there may be other covariates that we were not able to measure because we don’t have documentation in the chart," she said.

Despite such limitations, Dr. Wilson said that the findings support the notion of considering secondhand smoke exposure in risk stratification for children admitted with influenza. "Greater efforts are needed to help parents eliminate their children’s exposure to secondhand smoke," she said. "Parents of children with chronic illness should be aware of the risk of secondhand smoke exposure, and children exposed to secondhand smoke should be a priority group for influenza immunization."

Dr. Wilson disclosed that she is on the speakers bureau for the American Academy of Pediatrics Julius B. Richmond Center of Excellence, with funding from the Flight Attendant Medical Research Institute, National Research Service Award T32, Strong Children’s Research Center Summer Research Program, and the Child Health Corporation of America through a grant to the Pediatric Research in Inpatient Settings Network.

DENVER – Children exposed to secondhand tobacco smoke who are admitted to the hospital for influenza are more likely to require admission to the intensive care unit and have a longer hospital stay than their peers who are not exposed to secondhand smoke.

These effects are even greater for children with chronic illnesses who are exposed to secondhand smoke, Dr. Karen M. Wilson reported at the annual meeting of the Pediatric Academic Societies.

An estimated 18% of children aged 3-11 years are regularly exposed to secondhand tobacco smoke inside the home, said Dr. Wilson, assistant professor of pediatrics at the University of Rochester (N.Y.).

Although secondhand smoke exposure is associated with worse outcomes for children’s illnesses, including respiratory syncytial virus and asthma, "the effect of secondhand smoke exposure on influenza severity in children is unclear," she noted. "More than 40% of preschool children experience influenza at some point. In adults, tobacco smoke increases the risk of influenza infection and the risk of complications."

To determine if children hospitalized with influenza who are exposed to secondhand smoke have more severe illness, Dr. Wilson and her associates conducted a review of 169 medical charts at Golisano Children’s Hospital in Rochester. They generated a list of patients aged 0-15 years with a discharge diagnosis of influenza between 2002 and 2009. The influenza diagnosis was verified by laboratory review.

Measures of severity included intensive care unit admission, defined as admission or transfer to the ICU at any time during the stay; need for mechanical ventilation, defined as any documentation of endotracheal intubation during the stay; and length of stay.

Exposure to secondhand smoke was assessed by any documentation of presence or absence of secondhand smoke exposure by any provider. "Any documentation of exposure was considered exposed; documentation of no exposure was considered not exposed," Dr. Wilson said.

She reported findings from 113 children who were included in the final analysis. Of these, 46 (41%) were exposed to secondhand smoke and 67 (59%) were not. The average age of the 113 children was 4 years, and 50% were male. Of the 113 children, 58% were white, 22% were black, 8% were Hispanic, and 3.5% were Asian; race/ethnicity was unknown in the remaining 8.5%. Fewer than half of the children (44%) had public health insurance.

More than three-quarters of the children (78%) had influenza A. In addition, 25% had asthma, 25% had an underlying chronic condition, 14% had documentation of prematurity, 19% required ICU care, and 6% required mechanical ventilation.

None of the potential covariates – including asthma, prematurity, and chronic conditions – were significantly associated with secondhand smoke exposure. However, children exposed to secondhand smoke were significantly more likely to require ICU admission (31% vs. 10% for children with no exposure) and mechanical ventilation (13% vs. 2%, respectively).

The mean length of stay was 2.1 days for children who had no chronic condition or exposure to secondhand smoke, 2.5 days for children who had no chronic condition but had exposure to secondhand smoke, 3.5 days for children who had a chronic condition but no exposure to secondhand smoke, and 11 days for children who had a chronic condition and were exposed to secondhand smoke.

In a logistic regression model controlling for age, gender, race, and type of insurance, exposure to secondhand smoke was significantly associated with ICU admission but chronic conditions were not.

In a logistic regression model limited to exposure to secondhand smoke and chronic conditions, chronic conditions were associated with the need for mechanical ventilation but exposure to secondhand smoke was not.

In a negative binomial regression model using the log-transformed length of stay, controlling for age, gender, race, insurance type, and chronic conditions, exposure to secondhand smoke was associated with an increased length of hospital stay, with an incident rate ratio of 1.9.

Dr. Wilson acknowledged certain limitations of the study, including its single-center design "and the potential for errors in documentation and abstraction," she said. "The exposure measure was reliant on provider documentation ... but provider documentation is more likely to underestimate secondhand smoke exposure in children, so we probably misclassified some children as being non–smoke exposed."

In addition, "there may be other covariates that we were not able to measure because we don’t have documentation in the chart," she said.

Despite such limitations, Dr. Wilson said that the findings support the notion of considering secondhand smoke exposure in risk stratification for children admitted with influenza. "Greater efforts are needed to help parents eliminate their children’s exposure to secondhand smoke," she said. "Parents of children with chronic illness should be aware of the risk of secondhand smoke exposure, and children exposed to secondhand smoke should be a priority group for influenza immunization."

Dr. Wilson disclosed that she is on the speakers bureau for the American Academy of Pediatrics Julius B. Richmond Center of Excellence, with funding from the Flight Attendant Medical Research Institute, National Research Service Award T32, Strong Children’s Research Center Summer Research Program, and the Child Health Corporation of America through a grant to the Pediatric Research in Inpatient Settings Network.

DENVER – Children exposed to secondhand tobacco smoke who are admitted to the hospital for influenza are more likely to require admission to the intensive care unit and have a longer hospital stay than their peers who are not exposed to secondhand smoke.

These effects are even greater for children with chronic illnesses who are exposed to secondhand smoke, Dr. Karen M. Wilson reported at the annual meeting of the Pediatric Academic Societies.

An estimated 18% of children aged 3-11 years are regularly exposed to secondhand tobacco smoke inside the home, said Dr. Wilson, assistant professor of pediatrics at the University of Rochester (N.Y.).

Although secondhand smoke exposure is associated with worse outcomes for children’s illnesses, including respiratory syncytial virus and asthma, "the effect of secondhand smoke exposure on influenza severity in children is unclear," she noted. "More than 40% of preschool children experience influenza at some point. In adults, tobacco smoke increases the risk of influenza infection and the risk of complications."

To determine if children hospitalized with influenza who are exposed to secondhand smoke have more severe illness, Dr. Wilson and her associates conducted a review of 169 medical charts at Golisano Children’s Hospital in Rochester. They generated a list of patients aged 0-15 years with a discharge diagnosis of influenza between 2002 and 2009. The influenza diagnosis was verified by laboratory review.

Measures of severity included intensive care unit admission, defined as admission or transfer to the ICU at any time during the stay; need for mechanical ventilation, defined as any documentation of endotracheal intubation during the stay; and length of stay.

Exposure to secondhand smoke was assessed by any documentation of presence or absence of secondhand smoke exposure by any provider. "Any documentation of exposure was considered exposed; documentation of no exposure was considered not exposed," Dr. Wilson said.

She reported findings from 113 children who were included in the final analysis. Of these, 46 (41%) were exposed to secondhand smoke and 67 (59%) were not. The average age of the 113 children was 4 years, and 50% were male. Of the 113 children, 58% were white, 22% were black, 8% were Hispanic, and 3.5% were Asian; race/ethnicity was unknown in the remaining 8.5%. Fewer than half of the children (44%) had public health insurance.

More than three-quarters of the children (78%) had influenza A. In addition, 25% had asthma, 25% had an underlying chronic condition, 14% had documentation of prematurity, 19% required ICU care, and 6% required mechanical ventilation.

None of the potential covariates – including asthma, prematurity, and chronic conditions – were significantly associated with secondhand smoke exposure. However, children exposed to secondhand smoke were significantly more likely to require ICU admission (31% vs. 10% for children with no exposure) and mechanical ventilation (13% vs. 2%, respectively).

The mean length of stay was 2.1 days for children who had no chronic condition or exposure to secondhand smoke, 2.5 days for children who had no chronic condition but had exposure to secondhand smoke, 3.5 days for children who had a chronic condition but no exposure to secondhand smoke, and 11 days for children who had a chronic condition and were exposed to secondhand smoke.

In a logistic regression model controlling for age, gender, race, and type of insurance, exposure to secondhand smoke was significantly associated with ICU admission but chronic conditions were not.

In a logistic regression model limited to exposure to secondhand smoke and chronic conditions, chronic conditions were associated with the need for mechanical ventilation but exposure to secondhand smoke was not.

In a negative binomial regression model using the log-transformed length of stay, controlling for age, gender, race, insurance type, and chronic conditions, exposure to secondhand smoke was associated with an increased length of hospital stay, with an incident rate ratio of 1.9.

Dr. Wilson acknowledged certain limitations of the study, including its single-center design "and the potential for errors in documentation and abstraction," she said. "The exposure measure was reliant on provider documentation ... but provider documentation is more likely to underestimate secondhand smoke exposure in children, so we probably misclassified some children as being non–smoke exposed."

In addition, "there may be other covariates that we were not able to measure because we don’t have documentation in the chart," she said.

Despite such limitations, Dr. Wilson said that the findings support the notion of considering secondhand smoke exposure in risk stratification for children admitted with influenza. "Greater efforts are needed to help parents eliminate their children’s exposure to secondhand smoke," she said. "Parents of children with chronic illness should be aware of the risk of secondhand smoke exposure, and children exposed to secondhand smoke should be a priority group for influenza immunization."

Dr. Wilson disclosed that she is on the speakers bureau for the American Academy of Pediatrics Julius B. Richmond Center of Excellence, with funding from the Flight Attendant Medical Research Institute, National Research Service Award T32, Strong Children’s Research Center Summer Research Program, and the Child Health Corporation of America through a grant to the Pediatric Research in Inpatient Settings Network.

The Food and Drug Administration announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

“People with restless legs syndrome can experience considerable distress from their symptoms,” said Dr. Russell Katz, director of the FDA's Division of Neurology Products at the agency's Center for Drug Evaluation and Research, in a statement. “Horizant provides significant help in treating these symptoms.”

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is “characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief.” Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants.

Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, “and many patients go untreated as a result,” said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. “GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment” for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the “culmination of XenoPort's efforts to develop a nondopaminergic therapy” for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and “significant driving impairment,” according to GSK and XenoPort.

It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA.

The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

“People with restless legs syndrome can experience considerable distress from their symptoms,” said Dr. Russell Katz, director of the FDA's Division of Neurology Products at the agency's Center for Drug Evaluation and Research, in a statement. “Horizant provides significant help in treating these symptoms.”

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is “characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief.” Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants.

Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, “and many patients go untreated as a result,” said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. “GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment” for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the “culmination of XenoPort's efforts to develop a nondopaminergic therapy” for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and “significant driving impairment,” according to GSK and XenoPort.

It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA.

The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

“People with restless legs syndrome can experience considerable distress from their symptoms,” said Dr. Russell Katz, director of the FDA's Division of Neurology Products at the agency's Center for Drug Evaluation and Research, in a statement. “Horizant provides significant help in treating these symptoms.”

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is “characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief.” Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants.

Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, “and many patients go untreated as a result,” said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. “GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment” for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the “culmination of XenoPort's efforts to develop a nondopaminergic therapy” for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and “significant driving impairment,” according to GSK and XenoPort.

It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA.

The dosage also needs to be adjusted for patients with renal impairment.

TAMPA – Sharing bad news with patients might not be easy, but it’s a skill physicians can learn and as important as knowing how to ready an EKG or an x-ray, James A. Avery, MD, CMD, said.

"What I am proposing is that giving bad news well is a fundamental long-term care physician skill, and competence in this area is critical," Dr. Avery said at this year’s AMDA – Dedicated to Long Term Medicine annual meeting.

"Giving bad news ... takes desire, courage, and practice," said Dr. Avery. "Patients deserve to get bad news delivered with compassion, hope, and integrity."

Plan ahead for the conversation; start with what the patient knows and wants to know; and develop a compassionate tone, said Dr. Avery, chief medical officer at Golden Living in Washington, a corporation that focuses on skilled nursing, assisted living, and rehabilitation therapy. Also, always provide an appropriate prognosis. "It’s your obligation to bring this up. Patients and families may be afraid to ask."

What can happen if the conversation is not done correctly? "If bad news is given poorly, it can rob hope and create distress, confusion, and anxiety. It can weaken the patient’s faith and set off a chain of events that adversely affects the survivors for years," said Dr. Avery.

"I was particularly bad at giving bad news at first," he said. A pulmonologist by training, he also worked for years in hospice care in both Florida and New York. He spoke with patients who transitioned to hospice from Memorial Sloan-Kettering Cancer Center, for example.

"I learned quickly that if I was going to give bad news, not to schedule the patient for midmorning on a Monday. It is too chaotic," Dr. Avery said. Schedule the patient for the first appointment after lunch or at the end of the day. Allow sufficient time and create a comfortable, private place with tissues available, he added.

Next, determine where each patient is in terms of understanding his or her illness. "Explore and ask," Dr. Avery said. Good questions include:

• Is there anyone else you want to have in the conversation?
• How do you understand what has happened to you medically?
• What have doctors told you about this illness?
• What do you think caused this illness?

"I cannot tell you how many patients with colon cancer thought they had it because they took too many antacids," Dr. Avery said. "Also, I had one woman with breast cancer who responded ‘Burger King.’ She had read an article that fatty foods caused breast cancer. She had guilt that she was leaving her family because she ate burgers instead of salads."

Also, determine how much the patient wants to know. "About 90% of patients want full information [about their condition], but everyone wants to know everything about treatment." Physicians also can be instrumental in allaying end-of-life fears, Dr. Avery said. Regardless of illness, most patients think some symptom is going to get worse and worse and crescendo in pain before they die. "How do people with [chronic obstructive pulmonary disease] die? Yes, the symptoms get worse, but with COPD, they get COPD narcosis, get sleepy, and drift away."

Intentionally develop and use a compassionate tone, Dr. Avery said. This is important because patients surveyed after they received bad news said the attitude of the person who spoke with them was the most important factor. The clarity of the message and privacy were also important, but they ranked far behind clinician attitude, he said.

Allow for silence. Let the message to sink in. "Give the patient plenty of time to react, respond, and ask questions." Also allow tears – "That can be a real problem for a lot of doctors."

A challenge for physicians is to be empathetic without breaking down completely, Dr. Avery said. When working in hospice care in New York, he frequently spent the day traveling by subway to clients’ residences. "Am I going to travel around weeping? No. You have to somehow try to meet where they are, but you cannot go there completely. It would be self-destructive."

"One reason physicians think they do not give bad news well is they fear their own response; that they will break down," Dr. Avery said. Try to determine the patient’s attitude and reflect it back to them. "This is what you do when things get emotional. And they will correct you if you’re wrong. If you say ‘You sound angry,’ they might say ‘No, I’m upset.’"

Another important thing to ask patients is "Have the doctors told you how long you have?" An accurate prognosis will help patients and family prepare, Dr. Avery said. "You have to tell them. If you don’t, they will seek a second opinion and/or leave the long-term care setting, because no one has told them." Less-experienced doctors and doctors who have had long and strong relationship with a patient can be especially poor at prognostication, he said.

Be completely honest and avoid stating a precise amount of time, such as "3 months." "I say, ‘It could be weeks instead of months,’ or, ‘It could be months instead of years.’ If they ask for a more precise prognosis, tell them it’s difficult to say, because it is," Dr. Avery said.

If you still do not feel comfortable giving a patient bad news, refer the patient to someone who does. "Call in hospice, call in palliative care. If you cannot give that bad news, you are obligated to do this," Dr. Avery said.

If your attitude is right and you’re speaking with a compassionate tone, what else should you keep in mind when giving a patient bad news?

Watch your body language, because about 90% of communication is nonverbal, Dr. Avery said. Make eye contact, for example.

Do not sound matter of fact. "Patients will say the doctor appears bored," Dr. Avery explained. At the same time, avoid rambling, he advised. A good way to do this is intentionally pause on a frequent basis. Develop a technique to slow yourself down. Dr. Avery said he silently counts backward from 10 to slow himself down, for example.

Provide information in small chunks. This is better than "the information dump," which is a tendency to disclose every detail to a patient when initial bad news is shared.

"I tell the patient she can raise her hand and stop me if it’s too much information at any point," he said.

Never say, ‘There is nothing more I can do for you," Dr. Avery advised. He said he often tells patients that there is nothing more he can do for their dementia or their cancer, "but there is a lot I can do for you as a person. ... Otherwise, you are referring to them as a lung cancer, and you’ve reduced them to an organ with a disease."

You also can admit the limitations of medicine, Dr. Avery said. "You can say, for example, ‘I wish we had more effective therapy for your condition,’ or ‘I wish I had a magic pill or magic wand I could use it to take away your cancer.’ "

Dr. Avery said that he had no relevant financial conflict of interest.

TAMPA – Sharing bad news with patients might not be easy, but it’s a skill physicians can learn and as important as knowing how to ready an EKG or an x-ray, James A. Avery, MD, CMD, said.

"What I am proposing is that giving bad news well is a fundamental long-term care physician skill, and competence in this area is critical," Dr. Avery said at this year’s AMDA – Dedicated to Long Term Medicine annual meeting.

"Giving bad news ... takes desire, courage, and practice," said Dr. Avery. "Patients deserve to get bad news delivered with compassion, hope, and integrity."

Plan ahead for the conversation; start with what the patient knows and wants to know; and develop a compassionate tone, said Dr. Avery, chief medical officer at Golden Living in Washington, a corporation that focuses on skilled nursing, assisted living, and rehabilitation therapy. Also, always provide an appropriate prognosis. "It’s your obligation to bring this up. Patients and families may be afraid to ask."

What can happen if the conversation is not done correctly? "If bad news is given poorly, it can rob hope and create distress, confusion, and anxiety. It can weaken the patient’s faith and set off a chain of events that adversely affects the survivors for years," said Dr. Avery.

"I was particularly bad at giving bad news at first," he said. A pulmonologist by training, he also worked for years in hospice care in both Florida and New York. He spoke with patients who transitioned to hospice from Memorial Sloan-Kettering Cancer Center, for example.

"I learned quickly that if I was going to give bad news, not to schedule the patient for midmorning on a Monday. It is too chaotic," Dr. Avery said. Schedule the patient for the first appointment after lunch or at the end of the day. Allow sufficient time and create a comfortable, private place with tissues available, he added.

Next, determine where each patient is in terms of understanding his or her illness. "Explore and ask," Dr. Avery said. Good questions include:

• Is there anyone else you want to have in the conversation?
• How do you understand what has happened to you medically?
• What have doctors told you about this illness?
• What do you think caused this illness?

"I cannot tell you how many patients with colon cancer thought they had it because they took too many antacids," Dr. Avery said. "Also, I had one woman with breast cancer who responded ‘Burger King.’ She had read an article that fatty foods caused breast cancer. She had guilt that she was leaving her family because she ate burgers instead of salads."

Also, determine how much the patient wants to know. "About 90% of patients want full information [about their condition], but everyone wants to know everything about treatment." Physicians also can be instrumental in allaying end-of-life fears, Dr. Avery said. Regardless of illness, most patients think some symptom is going to get worse and worse and crescendo in pain before they die. "How do people with [chronic obstructive pulmonary disease] die? Yes, the symptoms get worse, but with COPD, they get COPD narcosis, get sleepy, and drift away."

Intentionally develop and use a compassionate tone, Dr. Avery said. This is important because patients surveyed after they received bad news said the attitude of the person who spoke with them was the most important factor. The clarity of the message and privacy were also important, but they ranked far behind clinician attitude, he said.

Allow for silence. Let the message to sink in. "Give the patient plenty of time to react, respond, and ask questions." Also allow tears – "That can be a real problem for a lot of doctors."

A challenge for physicians is to be empathetic without breaking down completely, Dr. Avery said. When working in hospice care in New York, he frequently spent the day traveling by subway to clients’ residences. "Am I going to travel around weeping? No. You have to somehow try to meet where they are, but you cannot go there completely. It would be self-destructive."

"One reason physicians think they do not give bad news well is they fear their own response; that they will break down," Dr. Avery said. Try to determine the patient’s attitude and reflect it back to them. "This is what you do when things get emotional. And they will correct you if you’re wrong. If you say ‘You sound angry,’ they might say ‘No, I’m upset.’"

Another important thing to ask patients is "Have the doctors told you how long you have?" An accurate prognosis will help patients and family prepare, Dr. Avery said. "You have to tell them. If you don’t, they will seek a second opinion and/or leave the long-term care setting, because no one has told them." Less-experienced doctors and doctors who have had long and strong relationship with a patient can be especially poor at prognostication, he said.

Be completely honest and avoid stating a precise amount of time, such as "3 months." "I say, ‘It could be weeks instead of months,’ or, ‘It could be months instead of years.’ If they ask for a more precise prognosis, tell them it’s difficult to say, because it is," Dr. Avery said.

If you still do not feel comfortable giving a patient bad news, refer the patient to someone who does. "Call in hospice, call in palliative care. If you cannot give that bad news, you are obligated to do this," Dr. Avery said.

If your attitude is right and you’re speaking with a compassionate tone, what else should you keep in mind when giving a patient bad news?

Watch your body language, because about 90% of communication is nonverbal, Dr. Avery said. Make eye contact, for example.

Do not sound matter of fact. "Patients will say the doctor appears bored," Dr. Avery explained. At the same time, avoid rambling, he advised. A good way to do this is intentionally pause on a frequent basis. Develop a technique to slow yourself down. Dr. Avery said he silently counts backward from 10 to slow himself down, for example.

Provide information in small chunks. This is better than "the information dump," which is a tendency to disclose every detail to a patient when initial bad news is shared.

"I tell the patient she can raise her hand and stop me if it’s too much information at any point," he said.

Never say, ‘There is nothing more I can do for you," Dr. Avery advised. He said he often tells patients that there is nothing more he can do for their dementia or their cancer, "but there is a lot I can do for you as a person. ... Otherwise, you are referring to them as a lung cancer, and you’ve reduced them to an organ with a disease."

You also can admit the limitations of medicine, Dr. Avery said. "You can say, for example, ‘I wish we had more effective therapy for your condition,’ or ‘I wish I had a magic pill or magic wand I could use it to take away your cancer.’ "

Dr. Avery said that he had no relevant financial conflict of interest.

TAMPA – Sharing bad news with patients might not be easy, but it’s a skill physicians can learn and as important as knowing how to ready an EKG or an x-ray, James A. Avery, MD, CMD, said.

"What I am proposing is that giving bad news well is a fundamental long-term care physician skill, and competence in this area is critical," Dr. Avery said at this year’s AMDA – Dedicated to Long Term Medicine annual meeting.

"Giving bad news ... takes desire, courage, and practice," said Dr. Avery. "Patients deserve to get bad news delivered with compassion, hope, and integrity."

Plan ahead for the conversation; start with what the patient knows and wants to know; and develop a compassionate tone, said Dr. Avery, chief medical officer at Golden Living in Washington, a corporation that focuses on skilled nursing, assisted living, and rehabilitation therapy. Also, always provide an appropriate prognosis. "It’s your obligation to bring this up. Patients and families may be afraid to ask."

What can happen if the conversation is not done correctly? "If bad news is given poorly, it can rob hope and create distress, confusion, and anxiety. It can weaken the patient’s faith and set off a chain of events that adversely affects the survivors for years," said Dr. Avery.

"I was particularly bad at giving bad news at first," he said. A pulmonologist by training, he also worked for years in hospice care in both Florida and New York. He spoke with patients who transitioned to hospice from Memorial Sloan-Kettering Cancer Center, for example.

"I learned quickly that if I was going to give bad news, not to schedule the patient for midmorning on a Monday. It is too chaotic," Dr. Avery said. Schedule the patient for the first appointment after lunch or at the end of the day. Allow sufficient time and create a comfortable, private place with tissues available, he added.

Next, determine where each patient is in terms of understanding his or her illness. "Explore and ask," Dr. Avery said. Good questions include:

• Is there anyone else you want to have in the conversation?
• How do you understand what has happened to you medically?
• What have doctors told you about this illness?
• What do you think caused this illness?

"I cannot tell you how many patients with colon cancer thought they had it because they took too many antacids," Dr. Avery said. "Also, I had one woman with breast cancer who responded ‘Burger King.’ She had read an article that fatty foods caused breast cancer. She had guilt that she was leaving her family because she ate burgers instead of salads."

Also, determine how much the patient wants to know. "About 90% of patients want full information [about their condition], but everyone wants to know everything about treatment." Physicians also can be instrumental in allaying end-of-life fears, Dr. Avery said. Regardless of illness, most patients think some symptom is going to get worse and worse and crescendo in pain before they die. "How do people with [chronic obstructive pulmonary disease] die? Yes, the symptoms get worse, but with COPD, they get COPD narcosis, get sleepy, and drift away."

Intentionally develop and use a compassionate tone, Dr. Avery said. This is important because patients surveyed after they received bad news said the attitude of the person who spoke with them was the most important factor. The clarity of the message and privacy were also important, but they ranked far behind clinician attitude, he said.

Allow for silence. Let the message to sink in. "Give the patient plenty of time to react, respond, and ask questions." Also allow tears – "That can be a real problem for a lot of doctors."

A challenge for physicians is to be empathetic without breaking down completely, Dr. Avery said. When working in hospice care in New York, he frequently spent the day traveling by subway to clients’ residences. "Am I going to travel around weeping? No. You have to somehow try to meet where they are, but you cannot go there completely. It would be self-destructive."

"One reason physicians think they do not give bad news well is they fear their own response; that they will break down," Dr. Avery said. Try to determine the patient’s attitude and reflect it back to them. "This is what you do when things get emotional. And they will correct you if you’re wrong. If you say ‘You sound angry,’ they might say ‘No, I’m upset.’"

Another important thing to ask patients is "Have the doctors told you how long you have?" An accurate prognosis will help patients and family prepare, Dr. Avery said. "You have to tell them. If you don’t, they will seek a second opinion and/or leave the long-term care setting, because no one has told them." Less-experienced doctors and doctors who have had long and strong relationship with a patient can be especially poor at prognostication, he said.

Be completely honest and avoid stating a precise amount of time, such as "3 months." "I say, ‘It could be weeks instead of months,’ or, ‘It could be months instead of years.’ If they ask for a more precise prognosis, tell them it’s difficult to say, because it is," Dr. Avery said.

If you still do not feel comfortable giving a patient bad news, refer the patient to someone who does. "Call in hospice, call in palliative care. If you cannot give that bad news, you are obligated to do this," Dr. Avery said.

If your attitude is right and you’re speaking with a compassionate tone, what else should you keep in mind when giving a patient bad news?

Watch your body language, because about 90% of communication is nonverbal, Dr. Avery said. Make eye contact, for example.

Do not sound matter of fact. "Patients will say the doctor appears bored," Dr. Avery explained. At the same time, avoid rambling, he advised. A good way to do this is intentionally pause on a frequent basis. Develop a technique to slow yourself down. Dr. Avery said he silently counts backward from 10 to slow himself down, for example.

Provide information in small chunks. This is better than "the information dump," which is a tendency to disclose every detail to a patient when initial bad news is shared.

"I tell the patient she can raise her hand and stop me if it’s too much information at any point," he said.

Never say, ‘There is nothing more I can do for you," Dr. Avery advised. He said he often tells patients that there is nothing more he can do for their dementia or their cancer, "but there is a lot I can do for you as a person. ... Otherwise, you are referring to them as a lung cancer, and you’ve reduced them to an organ with a disease."

You also can admit the limitations of medicine, Dr. Avery said. "You can say, for example, ‘I wish we had more effective therapy for your condition,’ or ‘I wish I had a magic pill or magic wand I could use it to take away your cancer.’ "

Dr. Avery said that he had no relevant financial conflict of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.