Miriam E. Tucker

LONDON – Hemodialysis and injection drug use were major risk factors for recurrent episodes of infective endocarditis among patients enrolled in a large international prospective study.

Repeat infective endocarditis (IE) is a serious complication of patients who survive an initial episode. In previous studies, the incidence has ranged from 2% to 31%. "Repeat IE is associated with significant mortality. It is an uncommon complication but can be highly relevant among specific groups of patients," Dr. Laura Alagna of San Raffaele Hospital, Milan, said at the European Congress of Clinical Microbiology and Infectious Diseases.

The findings come from The International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS), a contemporary cohort of more than 5,000 patients with infective endocarditis (IE) from 64 centers in 28 countries worldwide. Patients included in the current analysis were those enrolled from June 2000 to December 2006, with a diagnosis of definite IE on native or prosthetic valves who had at least a 1-year follow-up.

Of 1,857 patients who met inclusion criteria, 1,783 had one episode of IE and 91 (5%) had a repeat IE. Of those, 17 had a presumed relapse, defined clinically as infection with the same pathogen isolated within 6 months of the initial episode. The other 74 had a presumed new infection, defined clinically as a repeat episode with a different pathogen or the same pathogen isolated greater than 6 months from the initial episode.

On bivariate analysis, being from North America, infection with Staphylococcus aureus, hemodialysis dependence, intravenous drug use (IDU), HIV infection, history of previous IE, and non-nosocomial health care as a presumed source of infection were all associated with repeat IE. However, on multivariate analysis, only four independent risk factors emerged: North American location (odds ratio, 1.96), hemodialysis (OR, 2.54), IDU (OR, 2.89), and history of previous IE (2.76).

At 1-year follow-up, survival was significantly lower for those with repeat IE, 80% compared to 91% for those with only one episode (P = .0034), Dr. Alagna reported.

Molecular analysis with pulsed-gel electrophoresis performed in 12 of the repeat IE patients demonstrated concordance with the clinical definition in 10, including eight confirmed relapses and two confirmed new infections. Of the other two patients, one had S. aureus with the same molecular pattern isolated more than a year after the first episode. That patient was hemodialysis-dependent and had other risk factors. In the other discordant patient, S. bovis with the same molecular pattern was isolated after nearly 9 months. In that patient, a cardiac device had not been removed during the first episode, she explained.

"The clinical classification of repeat IE is satisfactory, but can be improved with molecular analysis," she concluded.

Dr. Alagna stated that she had no disclosures.

LONDON – Hemodialysis and injection drug use were major risk factors for recurrent episodes of infective endocarditis among patients enrolled in a large international prospective study.

Repeat infective endocarditis (IE) is a serious complication of patients who survive an initial episode. In previous studies, the incidence has ranged from 2% to 31%. "Repeat IE is associated with significant mortality. It is an uncommon complication but can be highly relevant among specific groups of patients," Dr. Laura Alagna of San Raffaele Hospital, Milan, said at the European Congress of Clinical Microbiology and Infectious Diseases.

The findings come from The International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS), a contemporary cohort of more than 5,000 patients with infective endocarditis (IE) from 64 centers in 28 countries worldwide. Patients included in the current analysis were those enrolled from June 2000 to December 2006, with a diagnosis of definite IE on native or prosthetic valves who had at least a 1-year follow-up.

Of 1,857 patients who met inclusion criteria, 1,783 had one episode of IE and 91 (5%) had a repeat IE. Of those, 17 had a presumed relapse, defined clinically as infection with the same pathogen isolated within 6 months of the initial episode. The other 74 had a presumed new infection, defined clinically as a repeat episode with a different pathogen or the same pathogen isolated greater than 6 months from the initial episode.

On bivariate analysis, being from North America, infection with Staphylococcus aureus, hemodialysis dependence, intravenous drug use (IDU), HIV infection, history of previous IE, and non-nosocomial health care as a presumed source of infection were all associated with repeat IE. However, on multivariate analysis, only four independent risk factors emerged: North American location (odds ratio, 1.96), hemodialysis (OR, 2.54), IDU (OR, 2.89), and history of previous IE (2.76).

At 1-year follow-up, survival was significantly lower for those with repeat IE, 80% compared to 91% for those with only one episode (P = .0034), Dr. Alagna reported.

Molecular analysis with pulsed-gel electrophoresis performed in 12 of the repeat IE patients demonstrated concordance with the clinical definition in 10, including eight confirmed relapses and two confirmed new infections. Of the other two patients, one had S. aureus with the same molecular pattern isolated more than a year after the first episode. That patient was hemodialysis-dependent and had other risk factors. In the other discordant patient, S. bovis with the same molecular pattern was isolated after nearly 9 months. In that patient, a cardiac device had not been removed during the first episode, she explained.

"The clinical classification of repeat IE is satisfactory, but can be improved with molecular analysis," she concluded.

Dr. Alagna stated that she had no disclosures.

LONDON – Hemodialysis and injection drug use were major risk factors for recurrent episodes of infective endocarditis among patients enrolled in a large international prospective study.

Repeat infective endocarditis (IE) is a serious complication of patients who survive an initial episode. In previous studies, the incidence has ranged from 2% to 31%. "Repeat IE is associated with significant mortality. It is an uncommon complication but can be highly relevant among specific groups of patients," Dr. Laura Alagna of San Raffaele Hospital, Milan, said at the European Congress of Clinical Microbiology and Infectious Diseases.

The findings come from The International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS), a contemporary cohort of more than 5,000 patients with infective endocarditis (IE) from 64 centers in 28 countries worldwide. Patients included in the current analysis were those enrolled from June 2000 to December 2006, with a diagnosis of definite IE on native or prosthetic valves who had at least a 1-year follow-up.

Of 1,857 patients who met inclusion criteria, 1,783 had one episode of IE and 91 (5%) had a repeat IE. Of those, 17 had a presumed relapse, defined clinically as infection with the same pathogen isolated within 6 months of the initial episode. The other 74 had a presumed new infection, defined clinically as a repeat episode with a different pathogen or the same pathogen isolated greater than 6 months from the initial episode.

On bivariate analysis, being from North America, infection with Staphylococcus aureus, hemodialysis dependence, intravenous drug use (IDU), HIV infection, history of previous IE, and non-nosocomial health care as a presumed source of infection were all associated with repeat IE. However, on multivariate analysis, only four independent risk factors emerged: North American location (odds ratio, 1.96), hemodialysis (OR, 2.54), IDU (OR, 2.89), and history of previous IE (2.76).

At 1-year follow-up, survival was significantly lower for those with repeat IE, 80% compared to 91% for those with only one episode (P = .0034), Dr. Alagna reported.

Molecular analysis with pulsed-gel electrophoresis performed in 12 of the repeat IE patients demonstrated concordance with the clinical definition in 10, including eight confirmed relapses and two confirmed new infections. Of the other two patients, one had S. aureus with the same molecular pattern isolated more than a year after the first episode. That patient was hemodialysis-dependent and had other risk factors. In the other discordant patient, S. bovis with the same molecular pattern was isolated after nearly 9 months. In that patient, a cardiac device had not been removed during the first episode, she explained.

"The clinical classification of repeat IE is satisfactory, but can be improved with molecular analysis," she concluded.

Dr. Alagna stated that she had no disclosures.

WASHINGTON – Delirium due to underlying medical conditions was misdiagnosed as a psychiatric disorder in a significant proportion of patients who were admitted to an inpatient geriatric psychiatric unit, a retrospective chart review found.

The analysis of charts from 112 consecutive patients admitted to Central Regional Hospital, Butler, N.C., with a diagnosis of a psychiatric disorder, showed that 27 (24%) were subsequently found to have delirium due to an underlying medical condition. All 27 also had prior psychiatric diagnoses. The results were reported at the annual meeting of the American Association for Geriatric Psychiatry.

"If a patient has a previous psychiatric history, physicians are not as scrupulous or as careful to screen them for underlying medical issues. They are more likely to send them to a psych unit, thinking all of their behavior manifestations are actually psychiatric. ... The message is be more careful and consider any behavioral manifestation as delirium until proven otherwise," Dr. Meera Balasubramaniam said in an interview.

Upon evaluation in the psychiatric unit, most of the patients were diagnosed with hyperactive delirium (23), with the other 4 having mixed delirium. Urinary tract infection was the most common medical etiology for the delirium (11), followed by medications (6), poor glycemic control (3), electrolyte disturbance (1), acute central nervous system events (1), and dehydration (1). The rest did not have a cause documented in the discharge summary, said Dr. Balasubramaniam, a psychiatry resident at Duke University, Durham, N.C.

Nearly half of the patients (12) had been referred from the emergency department, while another 11 had been sent from an inpatient medical unit. An additional 4 were referred from an inpatient psychiatry unit. Among the patients with delirium, the most common referral diagnosis was cognitive disorder (16), followed by psychotic disorder (7), and mood disorder (4).

The delirium group was significantly more likely than those without delirium to be transferred to medical units (41% vs. 4%), and was also more likely to be subsequently discharged to a higher level of care, such as assisted living or skilled nursing, although this was not statistically significant (33% vs. 28%). "The overall outcome was poorer than if the delirium had been recognized in the first place ... There’s a lot of expense involved," she commented.

Visual and hearing impairment were significantly more likely to be present in the patients with delirium, compared to those without, but no differences were found with regard to age, past psychiatric history, number or type of psychotropic medications, or Charlson comorbidity index, she and her associates reported in a poster.

The bottom line, she said: "Even if it’s a patient who has a previous psych history, be careful about making sure they don’t have any underlying medical causes. Rule that out before sending them to a psych unit."

Dr. Balasubramaniam stated that she has no disclosures.

WASHINGTON – Delirium due to underlying medical conditions was misdiagnosed as a psychiatric disorder in a significant proportion of patients who were admitted to an inpatient geriatric psychiatric unit, a retrospective chart review found.

The analysis of charts from 112 consecutive patients admitted to Central Regional Hospital, Butler, N.C., with a diagnosis of a psychiatric disorder, showed that 27 (24%) were subsequently found to have delirium due to an underlying medical condition. All 27 also had prior psychiatric diagnoses. The results were reported at the annual meeting of the American Association for Geriatric Psychiatry.

"If a patient has a previous psychiatric history, physicians are not as scrupulous or as careful to screen them for underlying medical issues. They are more likely to send them to a psych unit, thinking all of their behavior manifestations are actually psychiatric. ... The message is be more careful and consider any behavioral manifestation as delirium until proven otherwise," Dr. Meera Balasubramaniam said in an interview.

Upon evaluation in the psychiatric unit, most of the patients were diagnosed with hyperactive delirium (23), with the other 4 having mixed delirium. Urinary tract infection was the most common medical etiology for the delirium (11), followed by medications (6), poor glycemic control (3), electrolyte disturbance (1), acute central nervous system events (1), and dehydration (1). The rest did not have a cause documented in the discharge summary, said Dr. Balasubramaniam, a psychiatry resident at Duke University, Durham, N.C.

Nearly half of the patients (12) had been referred from the emergency department, while another 11 had been sent from an inpatient medical unit. An additional 4 were referred from an inpatient psychiatry unit. Among the patients with delirium, the most common referral diagnosis was cognitive disorder (16), followed by psychotic disorder (7), and mood disorder (4).

The delirium group was significantly more likely than those without delirium to be transferred to medical units (41% vs. 4%), and was also more likely to be subsequently discharged to a higher level of care, such as assisted living or skilled nursing, although this was not statistically significant (33% vs. 28%). "The overall outcome was poorer than if the delirium had been recognized in the first place ... There’s a lot of expense involved," she commented.

Visual and hearing impairment were significantly more likely to be present in the patients with delirium, compared to those without, but no differences were found with regard to age, past psychiatric history, number or type of psychotropic medications, or Charlson comorbidity index, she and her associates reported in a poster.

The bottom line, she said: "Even if it’s a patient who has a previous psych history, be careful about making sure they don’t have any underlying medical causes. Rule that out before sending them to a psych unit."

Dr. Balasubramaniam stated that she has no disclosures.

WASHINGTON – Delirium due to underlying medical conditions was misdiagnosed as a psychiatric disorder in a significant proportion of patients who were admitted to an inpatient geriatric psychiatric unit, a retrospective chart review found.

The analysis of charts from 112 consecutive patients admitted to Central Regional Hospital, Butler, N.C., with a diagnosis of a psychiatric disorder, showed that 27 (24%) were subsequently found to have delirium due to an underlying medical condition. All 27 also had prior psychiatric diagnoses. The results were reported at the annual meeting of the American Association for Geriatric Psychiatry.

"If a patient has a previous psychiatric history, physicians are not as scrupulous or as careful to screen them for underlying medical issues. They are more likely to send them to a psych unit, thinking all of their behavior manifestations are actually psychiatric. ... The message is be more careful and consider any behavioral manifestation as delirium until proven otherwise," Dr. Meera Balasubramaniam said in an interview.

Upon evaluation in the psychiatric unit, most of the patients were diagnosed with hyperactive delirium (23), with the other 4 having mixed delirium. Urinary tract infection was the most common medical etiology for the delirium (11), followed by medications (6), poor glycemic control (3), electrolyte disturbance (1), acute central nervous system events (1), and dehydration (1). The rest did not have a cause documented in the discharge summary, said Dr. Balasubramaniam, a psychiatry resident at Duke University, Durham, N.C.

Nearly half of the patients (12) had been referred from the emergency department, while another 11 had been sent from an inpatient medical unit. An additional 4 were referred from an inpatient psychiatry unit. Among the patients with delirium, the most common referral diagnosis was cognitive disorder (16), followed by psychotic disorder (7), and mood disorder (4).

The delirium group was significantly more likely than those without delirium to be transferred to medical units (41% vs. 4%), and was also more likely to be subsequently discharged to a higher level of care, such as assisted living or skilled nursing, although this was not statistically significant (33% vs. 28%). "The overall outcome was poorer than if the delirium had been recognized in the first place ... There’s a lot of expense involved," she commented.

Visual and hearing impairment were significantly more likely to be present in the patients with delirium, compared to those without, but no differences were found with regard to age, past psychiatric history, number or type of psychotropic medications, or Charlson comorbidity index, she and her associates reported in a poster.

The bottom line, she said: "Even if it’s a patient who has a previous psych history, be careful about making sure they don’t have any underlying medical causes. Rule that out before sending them to a psych unit."

Dr. Balasubramaniam stated that she has no disclosures.

ORLANDO – Parents were able to identify patterns of nonrespiratory symptoms in their children that preceded loss of asthma control, a small study showed.

The findings, if replicated, suggest that parents could recognize these early patterns and potentially intervene to prevent loss of control, as well as asthma exacerbations. Currently, guidelines from the National Asthma Education Program recommend starting treatment once an asthma exacerbation has begun, and current asthma action plans focus mainly on respiratory tract symptoms. The guidelines do not provide specific information about what signs and symptoms might present before lower respiratory tract symptoms appear, said Dr. Lisanne Newton of the Cleveland Clinic.

Caregivers of children aged 2-11 years with persistent asthma completed daily diaries for 16 weeks, in which they categorized each of 41 signs and symptoms as usual, less than usual, or more than usual. The signs and symptoms were derived from a prior study in which caregivers had identified them as potential early warnings (J. Pediatr. 2009;154:877-81).

Of 33 caregivers (32 parents and 1 grandparent) enrolled, 27 completed at least some of the questionnaire, and 19 completed all 16 weeks. Nearly all of the parents were female, and two-thirds of the children were male. The parents had a mean age of 38 years, and the children had a mean age of 7 years. Two-thirds of the parents had a history of atopic disease themselves, Dr. Newton noted.

The caregivers completed diary entries for 82% of days overall. At least one episode of loss of control, defined as 2 or more consecutive days of increased lower respiratory symptoms, occurred in 78% of the children. A total of 41% had at least one course of oral corticosteroids, 22% had at least one emergency department visit, and 41% had at least one unexpected medical provider visit.

Overall there was a significant change from baseline in all symptom types during an episode, compared with a controlled period, which was defined as the days excluding the episodes and the 5 days prior and 2 days after an episode. The odds of a child having unusual nonrespiratory signs or symptoms were significant at 3 days, 2 days, and 1 day prior to an episode, compared with controlled periods, with odds ratios of 1.6, 2.1, and 2.3, respectively. The change from baseline in upper and lower respiratory symptoms in the 3 days prior to an episode was not significant, she said.

Specific nonrespiratory signs and symptoms included irritability, low activity levels, tiredness, and sunken eyes. Parents reported an unusual amount of irritability in their children starting 5 days before an episode, with odds ratios of 2.2 at 5 days ahead and 4.1 at 1 day ahead. Unusually low activity levels were significant starting at 3 days before an episode, with odds ratios of 2.7 at 3 days and 4.4 at 1 day prior to the episode. Tiredness was also significantly more common, with an odds ratio of 2.8 at 3 days and 7.6 at 1 day. Sunken eyes were reported starting at 2 days prior, with an odds ratio of 2.5. All of these signs and symptoms were even more common during an episode.

Surprisingly, the overall odds of a child having an unusual amount of an upper respiratory sign or symptom, compared with controlled periods, was not significant in the 5 days before an episode, though they were significant during an episode. An itchy throat was the only upper respiratory symptom that was significant, and only at 3 days (OR, 2.9) and 2 days (4.3) prior to and during an episode but not the day prior, she noted.

Though limited by a small sample size, some consistent symptom patterns were seen in 5 of the 12 children who had at least three episodes during the 16-week period. One child had an unusual amount of crying and irritability the day prior to two of his three episodes. Another child had an unusual amount of talking, activity, and energy in the 2 days before half of her episodes. A third child had sleeping problems in the 2 days prior to three-quarters of his episodes and watery eyes in the 2 days prior to half of his episodes.

There were no differences between episodes occurring during weeks when oral corticosteroids were prescribed versus episodes occurring during weeks when no oral corticosteroids were prescribed, Dr. Newton said.

Further investigation is needed to determine whether parents would treat their children when these symptoms occurred, and if treatment modification could prevent loss of asthma control and exacerbations, she said.

Dr. Newton stated that she had no relevant financial disclosures.

ORLANDO – Parents were able to identify patterns of nonrespiratory symptoms in their children that preceded loss of asthma control, a small study showed.

The findings, if replicated, suggest that parents could recognize these early patterns and potentially intervene to prevent loss of control, as well as asthma exacerbations. Currently, guidelines from the National Asthma Education Program recommend starting treatment once an asthma exacerbation has begun, and current asthma action plans focus mainly on respiratory tract symptoms. The guidelines do not provide specific information about what signs and symptoms might present before lower respiratory tract symptoms appear, said Dr. Lisanne Newton of the Cleveland Clinic.

Caregivers of children aged 2-11 years with persistent asthma completed daily diaries for 16 weeks, in which they categorized each of 41 signs and symptoms as usual, less than usual, or more than usual. The signs and symptoms were derived from a prior study in which caregivers had identified them as potential early warnings (J. Pediatr. 2009;154:877-81).

Of 33 caregivers (32 parents and 1 grandparent) enrolled, 27 completed at least some of the questionnaire, and 19 completed all 16 weeks. Nearly all of the parents were female, and two-thirds of the children were male. The parents had a mean age of 38 years, and the children had a mean age of 7 years. Two-thirds of the parents had a history of atopic disease themselves, Dr. Newton noted.

The caregivers completed diary entries for 82% of days overall. At least one episode of loss of control, defined as 2 or more consecutive days of increased lower respiratory symptoms, occurred in 78% of the children. A total of 41% had at least one course of oral corticosteroids, 22% had at least one emergency department visit, and 41% had at least one unexpected medical provider visit.

Overall there was a significant change from baseline in all symptom types during an episode, compared with a controlled period, which was defined as the days excluding the episodes and the 5 days prior and 2 days after an episode. The odds of a child having unusual nonrespiratory signs or symptoms were significant at 3 days, 2 days, and 1 day prior to an episode, compared with controlled periods, with odds ratios of 1.6, 2.1, and 2.3, respectively. The change from baseline in upper and lower respiratory symptoms in the 3 days prior to an episode was not significant, she said.

Specific nonrespiratory signs and symptoms included irritability, low activity levels, tiredness, and sunken eyes. Parents reported an unusual amount of irritability in their children starting 5 days before an episode, with odds ratios of 2.2 at 5 days ahead and 4.1 at 1 day ahead. Unusually low activity levels were significant starting at 3 days before an episode, with odds ratios of 2.7 at 3 days and 4.4 at 1 day prior to the episode. Tiredness was also significantly more common, with an odds ratio of 2.8 at 3 days and 7.6 at 1 day. Sunken eyes were reported starting at 2 days prior, with an odds ratio of 2.5. All of these signs and symptoms were even more common during an episode.

Surprisingly, the overall odds of a child having an unusual amount of an upper respiratory sign or symptom, compared with controlled periods, was not significant in the 5 days before an episode, though they were significant during an episode. An itchy throat was the only upper respiratory symptom that was significant, and only at 3 days (OR, 2.9) and 2 days (4.3) prior to and during an episode but not the day prior, she noted.

Though limited by a small sample size, some consistent symptom patterns were seen in 5 of the 12 children who had at least three episodes during the 16-week period. One child had an unusual amount of crying and irritability the day prior to two of his three episodes. Another child had an unusual amount of talking, activity, and energy in the 2 days before half of her episodes. A third child had sleeping problems in the 2 days prior to three-quarters of his episodes and watery eyes in the 2 days prior to half of his episodes.

There were no differences between episodes occurring during weeks when oral corticosteroids were prescribed versus episodes occurring during weeks when no oral corticosteroids were prescribed, Dr. Newton said.

Further investigation is needed to determine whether parents would treat their children when these symptoms occurred, and if treatment modification could prevent loss of asthma control and exacerbations, she said.

Dr. Newton stated that she had no relevant financial disclosures.

ORLANDO – Parents were able to identify patterns of nonrespiratory symptoms in their children that preceded loss of asthma control, a small study showed.

The findings, if replicated, suggest that parents could recognize these early patterns and potentially intervene to prevent loss of control, as well as asthma exacerbations. Currently, guidelines from the National Asthma Education Program recommend starting treatment once an asthma exacerbation has begun, and current asthma action plans focus mainly on respiratory tract symptoms. The guidelines do not provide specific information about what signs and symptoms might present before lower respiratory tract symptoms appear, said Dr. Lisanne Newton of the Cleveland Clinic.

Caregivers of children aged 2-11 years with persistent asthma completed daily diaries for 16 weeks, in which they categorized each of 41 signs and symptoms as usual, less than usual, or more than usual. The signs and symptoms were derived from a prior study in which caregivers had identified them as potential early warnings (J. Pediatr. 2009;154:877-81).

Of 33 caregivers (32 parents and 1 grandparent) enrolled, 27 completed at least some of the questionnaire, and 19 completed all 16 weeks. Nearly all of the parents were female, and two-thirds of the children were male. The parents had a mean age of 38 years, and the children had a mean age of 7 years. Two-thirds of the parents had a history of atopic disease themselves, Dr. Newton noted.

The caregivers completed diary entries for 82% of days overall. At least one episode of loss of control, defined as 2 or more consecutive days of increased lower respiratory symptoms, occurred in 78% of the children. A total of 41% had at least one course of oral corticosteroids, 22% had at least one emergency department visit, and 41% had at least one unexpected medical provider visit.

Overall there was a significant change from baseline in all symptom types during an episode, compared with a controlled period, which was defined as the days excluding the episodes and the 5 days prior and 2 days after an episode. The odds of a child having unusual nonrespiratory signs or symptoms were significant at 3 days, 2 days, and 1 day prior to an episode, compared with controlled periods, with odds ratios of 1.6, 2.1, and 2.3, respectively. The change from baseline in upper and lower respiratory symptoms in the 3 days prior to an episode was not significant, she said.

Specific nonrespiratory signs and symptoms included irritability, low activity levels, tiredness, and sunken eyes. Parents reported an unusual amount of irritability in their children starting 5 days before an episode, with odds ratios of 2.2 at 5 days ahead and 4.1 at 1 day ahead. Unusually low activity levels were significant starting at 3 days before an episode, with odds ratios of 2.7 at 3 days and 4.4 at 1 day prior to the episode. Tiredness was also significantly more common, with an odds ratio of 2.8 at 3 days and 7.6 at 1 day. Sunken eyes were reported starting at 2 days prior, with an odds ratio of 2.5. All of these signs and symptoms were even more common during an episode.

Surprisingly, the overall odds of a child having an unusual amount of an upper respiratory sign or symptom, compared with controlled periods, was not significant in the 5 days before an episode, though they were significant during an episode. An itchy throat was the only upper respiratory symptom that was significant, and only at 3 days (OR, 2.9) and 2 days (4.3) prior to and during an episode but not the day prior, she noted.

Though limited by a small sample size, some consistent symptom patterns were seen in 5 of the 12 children who had at least three episodes during the 16-week period. One child had an unusual amount of crying and irritability the day prior to two of his three episodes. Another child had an unusual amount of talking, activity, and energy in the 2 days before half of her episodes. A third child had sleeping problems in the 2 days prior to three-quarters of his episodes and watery eyes in the 2 days prior to half of his episodes.

There were no differences between episodes occurring during weeks when oral corticosteroids were prescribed versus episodes occurring during weeks when no oral corticosteroids were prescribed, Dr. Newton said.

Further investigation is needed to determine whether parents would treat their children when these symptoms occurred, and if treatment modification could prevent loss of asthma control and exacerbations, she said.

Dr. Newton stated that she had no relevant financial disclosures.

ORLANDO – A combination of fixed-dose mometasone furoate and formoterol fumarate improved lung function in patients with moderate to very severe chronic obstructive pulmonary disease.

The finding came from a 26-week, phase III, multicenter, double-blind, placebo-controlled study of 1,055 adults who were current or former smokers and had a prebronchodilator forced expiratory volume in 1 second (FEV₁)/ forced vital capacity ratio of 0.70 or less. Currently, three combinations of inhaled corticosteroid plus long-acting beta agonists are available for the treatment of COPD, but not this particular combination of mometasone furoate with formoterol fumarate administered with a metered-dose inhaler, which is licensed for asthma treatment in the United States under the name Dulera, Dr. Edward Kerwin said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The patients were randomized to one of five twice-daily metered-dose inhaler treatment arms: mometasone furoate 400 mcg/formoterol 10 mcg (MF400/F10), mometasone furoate 200 mcg/formoterol 10 mcg (MF200/F10), mometasone furoate 400 mcg alone (MF400), formoterol 10 mcg alone (F10), or placebo. A total of 840 of the 1,055 randomized patients completed the treatment period. About 80% of the patients were male, with a mean age of 59 years, and about three-quarters were white. Nearly half were current smokers, and all had smoked at one point in time, with an average of 40 pack-years.

The findings of this study also were published online in the International Journal of Chronic Obstructive Pulmonary Disease (Int. J. Chron. Obstruct. Pulmon. Dis. 2012;7:43-55).

One of the two coprimary endpoints, the contribution of F10 to the MF400/F10 combination at week 13, was reached with a statistically significant 109 mL difference in FEV₁ area under the curve, compared with MF 400 alone. The overall effect size was a 163 mL difference for MF400/F10 over placebo at 13 weeks. A comparison of MF 400/F10 with MF 400 monotherapy also demonstrated a statistically significant effect of the F10, with an improvement of 69 mL, reported Dr. Kerwin, of the Clinical Research Institute of Southern Oregon, Medford.

The other coprimary endpoint, the mean change from baseline in morning predose FEV₁ at the week 13 endpoint, showed the contribution of the MF component. It was statistically significant for MF400/F10 over F10 alone, at 111 mL, and for MF200/F10 over F10 alone, at 58 mL. An overall effect size of 128 mL was seen for MF400/F10 over placebo.

Among the secondary efficacy variables, the MF 400/F10 group exceeded the 4-point minimum clinically important difference on the St. George’s Respiratory Questionnaire, compared with placebo, with a significant effect size of 4.56 points at week 26. Statistically significant improvements in questionnaire total score for MF400/F10 over placebo were demonstrated at weeks 4, 13, and 26. However, the MF200/F10 dosage did not achieve the minimum clinically important difference, with only a 2.82 reduction, compared with placebo.

The proportion of COPD symptom–free nights improved by 0.15 with MF400/F10, compared with 0.06 for placebo, a significant difference over the 26-week period. However, there was no treatment difference between MF400/F10 and placebo in the proportion of patients with partly stable COPD at 26 weeks, with percentages ranging from 38% to 46% across treatment groups.

Time to first COPD exacerbation significantly improved with MF400/F10 over F10 alone, and an analysis excluding mild exacerbations showed that moderate to severe exacerbations were significantly more frequent with placebo than with MF400/F10, at 16.5% vs. 8.8%, Dr. Kerwin said.

Treatment with MF400/F10 was well tolerated, and the proportion of patients reporting treatment-emergent adverse events during the 26-week treatment period was similar between treatment groups, ranging from 26% in the MF400/F10 group to 33% in the F10 alone group. The most common of these were headache, upper respiratory tract infection, cough, COPD, and hypertension. Pneumonia did not occur in more than 1% in any treatment group. The incidence of oral candidiasis was low, occurring in no more than 2.4% of any group (five of the MF 400 alone patients), he reported.

This study was sponsored by Merck Sharp & Dohme. Dr. Kerwin disclosed that he has received consulting fees and/or speaking fees from Dey Laboratories, GlaxoSmithKline, MAP Pharma (AstraZeneca), Merck, Teva, and Sepracor.

ORLANDO – A combination of fixed-dose mometasone furoate and formoterol fumarate improved lung function in patients with moderate to very severe chronic obstructive pulmonary disease.

The finding came from a 26-week, phase III, multicenter, double-blind, placebo-controlled study of 1,055 adults who were current or former smokers and had a prebronchodilator forced expiratory volume in 1 second (FEV₁)/ forced vital capacity ratio of 0.70 or less. Currently, three combinations of inhaled corticosteroid plus long-acting beta agonists are available for the treatment of COPD, but not this particular combination of mometasone furoate with formoterol fumarate administered with a metered-dose inhaler, which is licensed for asthma treatment in the United States under the name Dulera, Dr. Edward Kerwin said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The patients were randomized to one of five twice-daily metered-dose inhaler treatment arms: mometasone furoate 400 mcg/formoterol 10 mcg (MF400/F10), mometasone furoate 200 mcg/formoterol 10 mcg (MF200/F10), mometasone furoate 400 mcg alone (MF400), formoterol 10 mcg alone (F10), or placebo. A total of 840 of the 1,055 randomized patients completed the treatment period. About 80% of the patients were male, with a mean age of 59 years, and about three-quarters were white. Nearly half were current smokers, and all had smoked at one point in time, with an average of 40 pack-years.

The findings of this study also were published online in the International Journal of Chronic Obstructive Pulmonary Disease (Int. J. Chron. Obstruct. Pulmon. Dis. 2012;7:43-55).

One of the two coprimary endpoints, the contribution of F10 to the MF400/F10 combination at week 13, was reached with a statistically significant 109 mL difference in FEV₁ area under the curve, compared with MF 400 alone. The overall effect size was a 163 mL difference for MF400/F10 over placebo at 13 weeks. A comparison of MF 400/F10 with MF 400 monotherapy also demonstrated a statistically significant effect of the F10, with an improvement of 69 mL, reported Dr. Kerwin, of the Clinical Research Institute of Southern Oregon, Medford.

The other coprimary endpoint, the mean change from baseline in morning predose FEV₁ at the week 13 endpoint, showed the contribution of the MF component. It was statistically significant for MF400/F10 over F10 alone, at 111 mL, and for MF200/F10 over F10 alone, at 58 mL. An overall effect size of 128 mL was seen for MF400/F10 over placebo.

Among the secondary efficacy variables, the MF 400/F10 group exceeded the 4-point minimum clinically important difference on the St. George’s Respiratory Questionnaire, compared with placebo, with a significant effect size of 4.56 points at week 26. Statistically significant improvements in questionnaire total score for MF400/F10 over placebo were demonstrated at weeks 4, 13, and 26. However, the MF200/F10 dosage did not achieve the minimum clinically important difference, with only a 2.82 reduction, compared with placebo.

The proportion of COPD symptom–free nights improved by 0.15 with MF400/F10, compared with 0.06 for placebo, a significant difference over the 26-week period. However, there was no treatment difference between MF400/F10 and placebo in the proportion of patients with partly stable COPD at 26 weeks, with percentages ranging from 38% to 46% across treatment groups.

Time to first COPD exacerbation significantly improved with MF400/F10 over F10 alone, and an analysis excluding mild exacerbations showed that moderate to severe exacerbations were significantly more frequent with placebo than with MF400/F10, at 16.5% vs. 8.8%, Dr. Kerwin said.

Treatment with MF400/F10 was well tolerated, and the proportion of patients reporting treatment-emergent adverse events during the 26-week treatment period was similar between treatment groups, ranging from 26% in the MF400/F10 group to 33% in the F10 alone group. The most common of these were headache, upper respiratory tract infection, cough, COPD, and hypertension. Pneumonia did not occur in more than 1% in any treatment group. The incidence of oral candidiasis was low, occurring in no more than 2.4% of any group (five of the MF 400 alone patients), he reported.

This study was sponsored by Merck Sharp & Dohme. Dr. Kerwin disclosed that he has received consulting fees and/or speaking fees from Dey Laboratories, GlaxoSmithKline, MAP Pharma (AstraZeneca), Merck, Teva, and Sepracor.

ORLANDO – A combination of fixed-dose mometasone furoate and formoterol fumarate improved lung function in patients with moderate to very severe chronic obstructive pulmonary disease.

The finding came from a 26-week, phase III, multicenter, double-blind, placebo-controlled study of 1,055 adults who were current or former smokers and had a prebronchodilator forced expiratory volume in 1 second (FEV₁)/ forced vital capacity ratio of 0.70 or less. Currently, three combinations of inhaled corticosteroid plus long-acting beta agonists are available for the treatment of COPD, but not this particular combination of mometasone furoate with formoterol fumarate administered with a metered-dose inhaler, which is licensed for asthma treatment in the United States under the name Dulera, Dr. Edward Kerwin said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The patients were randomized to one of five twice-daily metered-dose inhaler treatment arms: mometasone furoate 400 mcg/formoterol 10 mcg (MF400/F10), mometasone furoate 200 mcg/formoterol 10 mcg (MF200/F10), mometasone furoate 400 mcg alone (MF400), formoterol 10 mcg alone (F10), or placebo. A total of 840 of the 1,055 randomized patients completed the treatment period. About 80% of the patients were male, with a mean age of 59 years, and about three-quarters were white. Nearly half were current smokers, and all had smoked at one point in time, with an average of 40 pack-years.

The findings of this study also were published online in the International Journal of Chronic Obstructive Pulmonary Disease (Int. J. Chron. Obstruct. Pulmon. Dis. 2012;7:43-55).

One of the two coprimary endpoints, the contribution of F10 to the MF400/F10 combination at week 13, was reached with a statistically significant 109 mL difference in FEV₁ area under the curve, compared with MF 400 alone. The overall effect size was a 163 mL difference for MF400/F10 over placebo at 13 weeks. A comparison of MF 400/F10 with MF 400 monotherapy also demonstrated a statistically significant effect of the F10, with an improvement of 69 mL, reported Dr. Kerwin, of the Clinical Research Institute of Southern Oregon, Medford.

The other coprimary endpoint, the mean change from baseline in morning predose FEV₁ at the week 13 endpoint, showed the contribution of the MF component. It was statistically significant for MF400/F10 over F10 alone, at 111 mL, and for MF200/F10 over F10 alone, at 58 mL. An overall effect size of 128 mL was seen for MF400/F10 over placebo.

Among the secondary efficacy variables, the MF 400/F10 group exceeded the 4-point minimum clinically important difference on the St. George’s Respiratory Questionnaire, compared with placebo, with a significant effect size of 4.56 points at week 26. Statistically significant improvements in questionnaire total score for MF400/F10 over placebo were demonstrated at weeks 4, 13, and 26. However, the MF200/F10 dosage did not achieve the minimum clinically important difference, with only a 2.82 reduction, compared with placebo.

The proportion of COPD symptom–free nights improved by 0.15 with MF400/F10, compared with 0.06 for placebo, a significant difference over the 26-week period. However, there was no treatment difference between MF400/F10 and placebo in the proportion of patients with partly stable COPD at 26 weeks, with percentages ranging from 38% to 46% across treatment groups.

Time to first COPD exacerbation significantly improved with MF400/F10 over F10 alone, and an analysis excluding mild exacerbations showed that moderate to severe exacerbations were significantly more frequent with placebo than with MF400/F10, at 16.5% vs. 8.8%, Dr. Kerwin said.

Treatment with MF400/F10 was well tolerated, and the proportion of patients reporting treatment-emergent adverse events during the 26-week treatment period was similar between treatment groups, ranging from 26% in the MF400/F10 group to 33% in the F10 alone group. The most common of these were headache, upper respiratory tract infection, cough, COPD, and hypertension. Pneumonia did not occur in more than 1% in any treatment group. The incidence of oral candidiasis was low, occurring in no more than 2.4% of any group (five of the MF 400 alone patients), he reported.

This study was sponsored by Merck Sharp & Dohme. Dr. Kerwin disclosed that he has received consulting fees and/or speaking fees from Dey Laboratories, GlaxoSmithKline, MAP Pharma (AstraZeneca), Merck, Teva, and Sepracor.

ORLANDO – Children who have at least two diagnoses of the "allergic triad" – asthma, allergic rhinitis, and atopic dermatitis – often receive prescriptions from multiple physicians and may be at risk for substantial exposure to exogenous corticosteroids.

This finding, from a chart review of 197 pediatric patients seen between 2000 and 2010 at a single U.S. allergy/immunology clinic, "reinforces the need for improved communication and coordination of care," said Dr. Min Jung Lee of Cohen Children’s Medical Center of New York.

Of the 197 patients who had been diagnosed with at least two of the three ICD-9 codes for asthma, allergic rhinitis, and/or atopic dermatitis, 48% had all three conditions. Of the patients diagnosed with two of the three conditions, 67% had both asthma and allergic rhinitis, 16.5% had asthma and atopic dermatitis, and 16.5% had allergic rhinitis and atopic dermatitis, Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of the patients with asthma, 74% were treated with inhaled steroids. Of those, 36% received steroid prescriptions from multiple physicians, 29% from allergists alone, 21% from primary care physicians alone, and 9% from pulmonologists alone. Of the patients with allergic rhinitis, 62% were treated with intranasal steroids, of which 20% were given prescriptions by multiple physicians, 67% by allergists alone, 5% by primary care physicians alone, and 3% by otolaryngologists alone. Of those with atopic dermatitis, 75% were treated with topical steroids; of those, 41% received steroid prescriptions from multiple physicians, 23% from dermatologists alone, 21% from allergists alone, and 7% from primary care physicians alone. (There were small numbers from each group for which the specialty of the prescriber was unknown.)

Among the children with both asthma and allergic rhinitis, 55% were treated with corticosteroids for both conditions and 38% for one of the two conditions, while just 7% were not treated with corticosteroids. For those with asthma and atopic dermatitis, 59% were prescribed corticosteroids for both conditions and 23% for just one of the two, while 18% received no corticosteroids. For the allergic rhinitis plus atopic dermatitis group, 6% were treated with corticosteroids for both conditions and 82% for just one, while 12% received none.

For the 95 patients who had all three conditions, 41% were treated with corticosteroids for all three, 36% for two of the three, and 19% for one of the three. Just 4% of that group was not treated with corticosteroids, Dr. Lee reported.

In response to an audience member’s question about whether the prescriptions were coordinated, she replied, "No, usually we didn’t see any communication between physicians."

In an interview, the study’s principal investigator, Dr. James C. Fagin, noted, "Our concern is the cumulative effect, because there are so many physicians involved and the communication is so poor that the primary care physician may not know what the [specialist] is prescribing, or if the [specialist] changes that prescription to a more potent drug. Without the electronic medical record to cement all of this, it becomes difficult to manage. We are certainly guilty in our speciality because we’re not always notifying the primary care physician every time we change a prescription."

However, "in terms of asthma care, we want the primary care physician to be actively involved, but they aren’t always good at communicating with specialists about changes they make. ... Communication has to go both ways," added Dr. Fagin, director of pediatric allergy and clinical immunology and director of the Center for Childhood Asthma at the Cohen children’s center.

In response to another audience member’s question regarding the role of electronic medical records, Dr. Lee responded that "access to electronic pharmacy records would also be very beneficial for each of us to know what our patients are getting."

Both Dr. Lee and Dr. Fagin stated that they had no disclosures.

ORLANDO – Children who have at least two diagnoses of the "allergic triad" – asthma, allergic rhinitis, and atopic dermatitis – often receive prescriptions from multiple physicians and may be at risk for substantial exposure to exogenous corticosteroids.

This finding, from a chart review of 197 pediatric patients seen between 2000 and 2010 at a single U.S. allergy/immunology clinic, "reinforces the need for improved communication and coordination of care," said Dr. Min Jung Lee of Cohen Children’s Medical Center of New York.

Of the 197 patients who had been diagnosed with at least two of the three ICD-9 codes for asthma, allergic rhinitis, and/or atopic dermatitis, 48% had all three conditions. Of the patients diagnosed with two of the three conditions, 67% had both asthma and allergic rhinitis, 16.5% had asthma and atopic dermatitis, and 16.5% had allergic rhinitis and atopic dermatitis, Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of the patients with asthma, 74% were treated with inhaled steroids. Of those, 36% received steroid prescriptions from multiple physicians, 29% from allergists alone, 21% from primary care physicians alone, and 9% from pulmonologists alone. Of the patients with allergic rhinitis, 62% were treated with intranasal steroids, of which 20% were given prescriptions by multiple physicians, 67% by allergists alone, 5% by primary care physicians alone, and 3% by otolaryngologists alone. Of those with atopic dermatitis, 75% were treated with topical steroids; of those, 41% received steroid prescriptions from multiple physicians, 23% from dermatologists alone, 21% from allergists alone, and 7% from primary care physicians alone. (There were small numbers from each group for which the specialty of the prescriber was unknown.)

Among the children with both asthma and allergic rhinitis, 55% were treated with corticosteroids for both conditions and 38% for one of the two conditions, while just 7% were not treated with corticosteroids. For those with asthma and atopic dermatitis, 59% were prescribed corticosteroids for both conditions and 23% for just one of the two, while 18% received no corticosteroids. For the allergic rhinitis plus atopic dermatitis group, 6% were treated with corticosteroids for both conditions and 82% for just one, while 12% received none.

For the 95 patients who had all three conditions, 41% were treated with corticosteroids for all three, 36% for two of the three, and 19% for one of the three. Just 4% of that group was not treated with corticosteroids, Dr. Lee reported.

In response to an audience member’s question about whether the prescriptions were coordinated, she replied, "No, usually we didn’t see any communication between physicians."

In an interview, the study’s principal investigator, Dr. James C. Fagin, noted, "Our concern is the cumulative effect, because there are so many physicians involved and the communication is so poor that the primary care physician may not know what the [specialist] is prescribing, or if the [specialist] changes that prescription to a more potent drug. Without the electronic medical record to cement all of this, it becomes difficult to manage. We are certainly guilty in our speciality because we’re not always notifying the primary care physician every time we change a prescription."

However, "in terms of asthma care, we want the primary care physician to be actively involved, but they aren’t always good at communicating with specialists about changes they make. ... Communication has to go both ways," added Dr. Fagin, director of pediatric allergy and clinical immunology and director of the Center for Childhood Asthma at the Cohen children’s center.

In response to another audience member’s question regarding the role of electronic medical records, Dr. Lee responded that "access to electronic pharmacy records would also be very beneficial for each of us to know what our patients are getting."

Both Dr. Lee and Dr. Fagin stated that they had no disclosures.

ORLANDO – Children who have at least two diagnoses of the "allergic triad" – asthma, allergic rhinitis, and atopic dermatitis – often receive prescriptions from multiple physicians and may be at risk for substantial exposure to exogenous corticosteroids.

This finding, from a chart review of 197 pediatric patients seen between 2000 and 2010 at a single U.S. allergy/immunology clinic, "reinforces the need for improved communication and coordination of care," said Dr. Min Jung Lee of Cohen Children’s Medical Center of New York.

Of the 197 patients who had been diagnosed with at least two of the three ICD-9 codes for asthma, allergic rhinitis, and/or atopic dermatitis, 48% had all three conditions. Of the patients diagnosed with two of the three conditions, 67% had both asthma and allergic rhinitis, 16.5% had asthma and atopic dermatitis, and 16.5% had allergic rhinitis and atopic dermatitis, Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of the patients with asthma, 74% were treated with inhaled steroids. Of those, 36% received steroid prescriptions from multiple physicians, 29% from allergists alone, 21% from primary care physicians alone, and 9% from pulmonologists alone. Of the patients with allergic rhinitis, 62% were treated with intranasal steroids, of which 20% were given prescriptions by multiple physicians, 67% by allergists alone, 5% by primary care physicians alone, and 3% by otolaryngologists alone. Of those with atopic dermatitis, 75% were treated with topical steroids; of those, 41% received steroid prescriptions from multiple physicians, 23% from dermatologists alone, 21% from allergists alone, and 7% from primary care physicians alone. (There were small numbers from each group for which the specialty of the prescriber was unknown.)

Among the children with both asthma and allergic rhinitis, 55% were treated with corticosteroids for both conditions and 38% for one of the two conditions, while just 7% were not treated with corticosteroids. For those with asthma and atopic dermatitis, 59% were prescribed corticosteroids for both conditions and 23% for just one of the two, while 18% received no corticosteroids. For the allergic rhinitis plus atopic dermatitis group, 6% were treated with corticosteroids for both conditions and 82% for just one, while 12% received none.

For the 95 patients who had all three conditions, 41% were treated with corticosteroids for all three, 36% for two of the three, and 19% for one of the three. Just 4% of that group was not treated with corticosteroids, Dr. Lee reported.

In response to an audience member’s question about whether the prescriptions were coordinated, she replied, "No, usually we didn’t see any communication between physicians."

In an interview, the study’s principal investigator, Dr. James C. Fagin, noted, "Our concern is the cumulative effect, because there are so many physicians involved and the communication is so poor that the primary care physician may not know what the [specialist] is prescribing, or if the [specialist] changes that prescription to a more potent drug. Without the electronic medical record to cement all of this, it becomes difficult to manage. We are certainly guilty in our speciality because we’re not always notifying the primary care physician every time we change a prescription."

However, "in terms of asthma care, we want the primary care physician to be actively involved, but they aren’t always good at communicating with specialists about changes they make. ... Communication has to go both ways," added Dr. Fagin, director of pediatric allergy and clinical immunology and director of the Center for Childhood Asthma at the Cohen children’s center.

In response to another audience member’s question regarding the role of electronic medical records, Dr. Lee responded that "access to electronic pharmacy records would also be very beneficial for each of us to know what our patients are getting."

Both Dr. Lee and Dr. Fagin stated that they had no disclosures.

WASHINGTON – Monitoring for metabolic side effects proved to be infrequent for outpatients with dementia or delirium who had been prescribed antipsychotic medications at 32 Veterans Affairs medical centers.

Antipsychotic medications are approved by the Food and Drug Administration for use in patients with psychotic disorders, not for those with dementia and delirium. However, they are widely used off label to control behavior disturbances among dementia/delirium patients, despite the lack of long-term data. In 2004, the American Psychiatric Association (APA), the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity issued consensus recommendations for monitoring of glycemic control, lipidemia, and weight gain among all patients taking antipsychotics (Diabetes Care 2004;27:596-601).

Subsequently, in 2005 and 2008, the FDA issued black box warnings about the increased risk for mortality in dementia patients with the use of typical and atypical antipsychotics. Other risks include cerebrovascular events, parkinsonism, pulmonary infections, and metabolic dysfunction

"To my way of thinking, these patients are getting a medication that is not FDA approved for this indication and it has significant risks, so if I’m a prudent clinician, if I prescribe something off label, I have to be more careful," Dr. Dinesh Mittal said in an interview.

But his findings in a large, retrospective cohort analysis suggest that this is not happening. Of patients identified as having received a new antipsychotic prescription and used it for at least 60 days, 916 had dementia or delirium but no psychosis, whereas 3,446 had psychosis but no dementia/delirium. The dementia patients were a mean age of 69 years, nearly all were male (95%), and most were married (56%). Two-thirds of the dementia/delirium group (64%) were aged 65 and older, compared with just 9% of the psychosis patients, said Dr. Mittal, a research scientist at the VA’s Center for Mental Health Outcomes Research and staff psychiatrist at Central Arkansas Veterans Healthcare System, Little Rock.

At baseline (defined as within 30 days of the index prescription), monitoring of either glucose or hemoglobin A_1c had been done for only 45% of those with dementia/delirium who were without psychosis. The proportion was not significantly different (47.5%) for the patients with psychosis but no dementia/delirium. Measurement of LDL cholesterol was even less common in both groups and was significantly lower for the dementia/delirium patients (27% vs. 34% of those with psychosis). Also, significantly more dementia patients than psychosis patients had their weight checked at baseline (71% vs. 66%).

The difference in weight measurement might simply relate to the fact that dementia patients were being seen more often for office visits and were having weight measured routinely, rather than being monitored specifically for metabolic side effects of antipsychotics, noted Dr. Mittal, who is also with the University of Arkansas, Little Rock.

The proportions being monitored for all side effects had dropped by 90 days, with glucose/HbA_1c measurements in just 27% of both the dementia/delirium group and the psychosis group; LDL cholesterol in 12% and 17%, respectively; and weight in 48% and 50%. Of those, the only significant difference between groups was the lower LDL measurement for the dementia/delirium patients, Dr. Mittal and his associates reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

In the interview, Dr. Mittal commented that these results are particularly concerning given the absence of data to support the use of antipsychotics beyond a few days in dementia/delirium patients. The study sample was selected based on these patients’ having been prescribed antipsychotics for at least 60 days, which places them under the metabolic monitoring guidelines of the ADA and APA. "There are studies, but the only data [are] for short-term use for agitation of only a few days. That’s why we wanted to select a sample [of] prescribed antipsychotics long enough to get away from the data showing benefit," he explained.

The dilemma, he said, is that stopping an antipsychotic in a patient with dementia for whom they helped curb the agitation requires clinical judgment and is far more difficult in the outpatient setting, which was the focus of this study.

Although neither the psychotic nor the delirium/dementia patients were being adequately monitored for metabolic adverse effects, the delirium patients are older and might be at greater risk for morbidity and mortality while taking antipsychotics, Dr. Mittal said.

"Despite the risks of prescribing antipsychotics for patients with dementia, adherence to recommendations for monitoring metabolic side effects remains low. ... They’re being monitored as frequently as those with psychosis, but it’s not enough in either group."

Such monitoring must be accomplished via collaboration between primary care/endocrinology and mental health, he advised.

The study was funded by a health services grant from the VA’s Health Services Research & Development Service. Dr. Mittal stated that he had no other disclosures.

WASHINGTON – Monitoring for metabolic side effects proved to be infrequent for outpatients with dementia or delirium who had been prescribed antipsychotic medications at 32 Veterans Affairs medical centers.

Antipsychotic medications are approved by the Food and Drug Administration for use in patients with psychotic disorders, not for those with dementia and delirium. However, they are widely used off label to control behavior disturbances among dementia/delirium patients, despite the lack of long-term data. In 2004, the American Psychiatric Association (APA), the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity issued consensus recommendations for monitoring of glycemic control, lipidemia, and weight gain among all patients taking antipsychotics (Diabetes Care 2004;27:596-601).

Subsequently, in 2005 and 2008, the FDA issued black box warnings about the increased risk for mortality in dementia patients with the use of typical and atypical antipsychotics. Other risks include cerebrovascular events, parkinsonism, pulmonary infections, and metabolic dysfunction

"To my way of thinking, these patients are getting a medication that is not FDA approved for this indication and it has significant risks, so if I’m a prudent clinician, if I prescribe something off label, I have to be more careful," Dr. Dinesh Mittal said in an interview.

But his findings in a large, retrospective cohort analysis suggest that this is not happening. Of patients identified as having received a new antipsychotic prescription and used it for at least 60 days, 916 had dementia or delirium but no psychosis, whereas 3,446 had psychosis but no dementia/delirium. The dementia patients were a mean age of 69 years, nearly all were male (95%), and most were married (56%). Two-thirds of the dementia/delirium group (64%) were aged 65 and older, compared with just 9% of the psychosis patients, said Dr. Mittal, a research scientist at the VA’s Center for Mental Health Outcomes Research and staff psychiatrist at Central Arkansas Veterans Healthcare System, Little Rock.

At baseline (defined as within 30 days of the index prescription), monitoring of either glucose or hemoglobin A_1c had been done for only 45% of those with dementia/delirium who were without psychosis. The proportion was not significantly different (47.5%) for the patients with psychosis but no dementia/delirium. Measurement of LDL cholesterol was even less common in both groups and was significantly lower for the dementia/delirium patients (27% vs. 34% of those with psychosis). Also, significantly more dementia patients than psychosis patients had their weight checked at baseline (71% vs. 66%).

The difference in weight measurement might simply relate to the fact that dementia patients were being seen more often for office visits and were having weight measured routinely, rather than being monitored specifically for metabolic side effects of antipsychotics, noted Dr. Mittal, who is also with the University of Arkansas, Little Rock.

The proportions being monitored for all side effects had dropped by 90 days, with glucose/HbA_1c measurements in just 27% of both the dementia/delirium group and the psychosis group; LDL cholesterol in 12% and 17%, respectively; and weight in 48% and 50%. Of those, the only significant difference between groups was the lower LDL measurement for the dementia/delirium patients, Dr. Mittal and his associates reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

In the interview, Dr. Mittal commented that these results are particularly concerning given the absence of data to support the use of antipsychotics beyond a few days in dementia/delirium patients. The study sample was selected based on these patients’ having been prescribed antipsychotics for at least 60 days, which places them under the metabolic monitoring guidelines of the ADA and APA. "There are studies, but the only data [are] for short-term use for agitation of only a few days. That’s why we wanted to select a sample [of] prescribed antipsychotics long enough to get away from the data showing benefit," he explained.

The dilemma, he said, is that stopping an antipsychotic in a patient with dementia for whom they helped curb the agitation requires clinical judgment and is far more difficult in the outpatient setting, which was the focus of this study.

Although neither the psychotic nor the delirium/dementia patients were being adequately monitored for metabolic adverse effects, the delirium patients are older and might be at greater risk for morbidity and mortality while taking antipsychotics, Dr. Mittal said.

"Despite the risks of prescribing antipsychotics for patients with dementia, adherence to recommendations for monitoring metabolic side effects remains low. ... They’re being monitored as frequently as those with psychosis, but it’s not enough in either group."

Such monitoring must be accomplished via collaboration between primary care/endocrinology and mental health, he advised.

The study was funded by a health services grant from the VA’s Health Services Research & Development Service. Dr. Mittal stated that he had no other disclosures.

WASHINGTON – Monitoring for metabolic side effects proved to be infrequent for outpatients with dementia or delirium who had been prescribed antipsychotic medications at 32 Veterans Affairs medical centers.

Antipsychotic medications are approved by the Food and Drug Administration for use in patients with psychotic disorders, not for those with dementia and delirium. However, they are widely used off label to control behavior disturbances among dementia/delirium patients, despite the lack of long-term data. In 2004, the American Psychiatric Association (APA), the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity issued consensus recommendations for monitoring of glycemic control, lipidemia, and weight gain among all patients taking antipsychotics (Diabetes Care 2004;27:596-601).

Subsequently, in 2005 and 2008, the FDA issued black box warnings about the increased risk for mortality in dementia patients with the use of typical and atypical antipsychotics. Other risks include cerebrovascular events, parkinsonism, pulmonary infections, and metabolic dysfunction

"To my way of thinking, these patients are getting a medication that is not FDA approved for this indication and it has significant risks, so if I’m a prudent clinician, if I prescribe something off label, I have to be more careful," Dr. Dinesh Mittal said in an interview.

But his findings in a large, retrospective cohort analysis suggest that this is not happening. Of patients identified as having received a new antipsychotic prescription and used it for at least 60 days, 916 had dementia or delirium but no psychosis, whereas 3,446 had psychosis but no dementia/delirium. The dementia patients were a mean age of 69 years, nearly all were male (95%), and most were married (56%). Two-thirds of the dementia/delirium group (64%) were aged 65 and older, compared with just 9% of the psychosis patients, said Dr. Mittal, a research scientist at the VA’s Center for Mental Health Outcomes Research and staff psychiatrist at Central Arkansas Veterans Healthcare System, Little Rock.

At baseline (defined as within 30 days of the index prescription), monitoring of either glucose or hemoglobin A_1c had been done for only 45% of those with dementia/delirium who were without psychosis. The proportion was not significantly different (47.5%) for the patients with psychosis but no dementia/delirium. Measurement of LDL cholesterol was even less common in both groups and was significantly lower for the dementia/delirium patients (27% vs. 34% of those with psychosis). Also, significantly more dementia patients than psychosis patients had their weight checked at baseline (71% vs. 66%).

The difference in weight measurement might simply relate to the fact that dementia patients were being seen more often for office visits and were having weight measured routinely, rather than being monitored specifically for metabolic side effects of antipsychotics, noted Dr. Mittal, who is also with the University of Arkansas, Little Rock.

The proportions being monitored for all side effects had dropped by 90 days, with glucose/HbA_1c measurements in just 27% of both the dementia/delirium group and the psychosis group; LDL cholesterol in 12% and 17%, respectively; and weight in 48% and 50%. Of those, the only significant difference between groups was the lower LDL measurement for the dementia/delirium patients, Dr. Mittal and his associates reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

In the interview, Dr. Mittal commented that these results are particularly concerning given the absence of data to support the use of antipsychotics beyond a few days in dementia/delirium patients. The study sample was selected based on these patients’ having been prescribed antipsychotics for at least 60 days, which places them under the metabolic monitoring guidelines of the ADA and APA. "There are studies, but the only data [are] for short-term use for agitation of only a few days. That’s why we wanted to select a sample [of] prescribed antipsychotics long enough to get away from the data showing benefit," he explained.

The dilemma, he said, is that stopping an antipsychotic in a patient with dementia for whom they helped curb the agitation requires clinical judgment and is far more difficult in the outpatient setting, which was the focus of this study.

Although neither the psychotic nor the delirium/dementia patients were being adequately monitored for metabolic adverse effects, the delirium patients are older and might be at greater risk for morbidity and mortality while taking antipsychotics, Dr. Mittal said.

"Despite the risks of prescribing antipsychotics for patients with dementia, adherence to recommendations for monitoring metabolic side effects remains low. ... They’re being monitored as frequently as those with psychosis, but it’s not enough in either group."

Such monitoring must be accomplished via collaboration between primary care/endocrinology and mental health, he advised.

The study was funded by a health services grant from the VA’s Health Services Research & Development Service. Dr. Mittal stated that he had no other disclosures.

The American College of Rheumatology’s latest recommendations on treatment of osteoarthritis place new emphasis on early use of nonpharmacologic therapies, such as tai chi and acupuncture and advise against use of glucosamine/chondroitin.

"We placed an emphasis on non-pharmacologic treatments. ... Reimbursement is one of the issues. We really wanted to put some gravitas on the evaluation of the non-pharmacologic modalities. ... We wanted providers to be aware of what’s available for patients, what’s beneficial for patients, and what the recommendations of a group of experts are on how they should use these for patients even before they consider pharmacologic agents."

The new recommendations, which are ACR’s first to address hand OA, are also the first to be developed using a formal process for evidence-based recommendations. They "were derived using a state-of-the-art approach utilizing evidence from the most recent and best methodological quality systematic review of the individual treatment modalities in patients with osteoarthritis of the hand, hip, or knee," lead author Dr. Marc C. Hochberg said in an interview.

The approach, called Grades of Recommendation Assessment, Development, and Evaluation (GRADE), has been adopted by the World Health Organization, the Cochrane Collaboration, and the Agency for Healthcare Research and Quality, along with numerous professional organizations. The American College of Rheumatology has now officially adopted GRADE for future recommendations, said Dr. Hochberg, professor of medicine and epidemiology and public health and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The new recommendations, which replace those issued in 2000, are also the first to be developed by a multidisciplinary panel that included primary care physicians, physiatrists, and geriatricians along with rheumatologists (both academic and private practice), an orthopedic surgeon, and both physical and occupational therapists. Based on the strength of the evidence and using real-life patient examples, the panelists ranked each recommendation as either strong in favor of use, weak (or conditional), no recommendation, weak or conditional recommendation not to use, and strong recommendation not to use (Arthritis Care Res. 2012;64:465-74).

"These are much more real-world recommendations based on patients who present for consultation and would be applicable for the provider in their office situation when they see a patient. ... They’re meant for primary care physicians as well as rheumatologists," Dr. Hochberg said.

In fact, the new emphasis on non-pharmacologic therapies is done for the benefit of primary care physicians. "In the short period of time that primary care providers have to spend with their patients, [non-pharmacologic therapies are] often overlooked," said Dr. Hochberg.

For hand OA, the panel conditionally recommended evaluation of the patient’s ability to perform activities of daily living, instruction in joint protection techniques, assistive devices as needed, instruction in the use of thermal modalities, and splints for patients with trapeziometacarpal joint OA. Conditional pharmacologic recommendations for hand OA include topical capsaicin, topical nonsteroidal anti-inflammatory drugs (NSAIDs), and oral NSAIDs. The panel also conditionally recommended against the use of intra-articular therapies and opioid analgesics.

No strong recommendations were made for hand OA. "We only provided conditional recommendations for hand OA, which points to the relative dearth of studies in this area and then lack of good quality evidence to support treatments for it. Hand OA is an area that is in need of well-designed, large placebo-controlled and active-comparator studies," Dr. Hochberg commented.

For initial management of knee OA, the panel strongly recommended the nonpharmacologic interventions of participation in cardiovascular (aerobic) and/or resistance land-based exercise, participation in aquatic exercise, and weight loss if indicated. They conditionally recommended a long list of nonpharmacologic interventions, including participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial intervention, use of medially directed patellar taping, wedged insoles, thermal agents, walking aids as needed, participation in tai chi programs, treatment with Chinese acupuncture, and transcutaneous electrical stimulation.

No strong pharmacologic recommendations were made for the initial treatment of knee OA. Conditional recommendations included one of the following: acetaminophen, oral NSAIDs, topical NSAIDs, tramadol, or intra-articular corticosteroid injections. Conditional recommendations were made to not use chondroitin sulfate, glucosamine, or topical capsaicin.

Strong nonpharmacologic recommendations for hip OA included participation in cardiovascular and/or resistance land-based exercise, participation in aquatic exercise, and weight loss, if indicated. Conditional nonpharmacologic recommendations included participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial interventions, instruction in the use of thermal agents, and walking aids as needed.

As with knee OA, conditional pharmacologic recommendations for hip OA include one of either acetaminophen, oral NSAIDs, tramadol or intra-articular corticosteroid injections. As well, chondroitin sulfate and glucosamine were conditionally recommended against.

Dr. Hochberg acknowledged that despite the panel’s use of the rigorous evidence-based approach, the conditional recommendations for use of tai chi and acupuncture might prove controversial, as might the conditional recommendations against the use of intra-articular therapies for hand OA and glucosamine/chondroitin. The non-recommendation for the latter nutraceuticals was based on negative studies conducted on the products that are sold over the counter in the United States and Canada, which are different from the pharmaceutically produced preparations tested and sold in Europe, Dr. Hochberg explained.

Of note, there are no strong recommendations for pharmaceutical treatment of any joint area.

Dr. Hochberg disclosed that he has financial relationships with Abbott, Amgen, AstraZeneca, Bayer Health Care, Bioiberica, Bristol-Myers Squibb, CombinatoRx, Covidien, Eli Lilly, Genentech, GlaxoSmithKline, Hoffman-La Roche, Merck, Merck Serono International, NicOx, Novartis, Pfizer, Pozen, Rand Corporation, Sanofi-Aventis, Smith & Nephew, Stryker Biotech, Theralogix, TransPharma Medical, and UCB. He receives research support from the NIH.

The American College of Rheumatology’s latest recommendations on treatment of osteoarthritis place new emphasis on early use of nonpharmacologic therapies, such as tai chi and acupuncture and advise against use of glucosamine/chondroitin.

"We placed an emphasis on non-pharmacologic treatments. ... Reimbursement is one of the issues. We really wanted to put some gravitas on the evaluation of the non-pharmacologic modalities. ... We wanted providers to be aware of what’s available for patients, what’s beneficial for patients, and what the recommendations of a group of experts are on how they should use these for patients even before they consider pharmacologic agents."

The new recommendations, which are ACR’s first to address hand OA, are also the first to be developed using a formal process for evidence-based recommendations. They "were derived using a state-of-the-art approach utilizing evidence from the most recent and best methodological quality systematic review of the individual treatment modalities in patients with osteoarthritis of the hand, hip, or knee," lead author Dr. Marc C. Hochberg said in an interview.

The approach, called Grades of Recommendation Assessment, Development, and Evaluation (GRADE), has been adopted by the World Health Organization, the Cochrane Collaboration, and the Agency for Healthcare Research and Quality, along with numerous professional organizations. The American College of Rheumatology has now officially adopted GRADE for future recommendations, said Dr. Hochberg, professor of medicine and epidemiology and public health and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The new recommendations, which replace those issued in 2000, are also the first to be developed by a multidisciplinary panel that included primary care physicians, physiatrists, and geriatricians along with rheumatologists (both academic and private practice), an orthopedic surgeon, and both physical and occupational therapists. Based on the strength of the evidence and using real-life patient examples, the panelists ranked each recommendation as either strong in favor of use, weak (or conditional), no recommendation, weak or conditional recommendation not to use, and strong recommendation not to use (Arthritis Care Res. 2012;64:465-74).

"These are much more real-world recommendations based on patients who present for consultation and would be applicable for the provider in their office situation when they see a patient. ... They’re meant for primary care physicians as well as rheumatologists," Dr. Hochberg said.

In fact, the new emphasis on non-pharmacologic therapies is done for the benefit of primary care physicians. "In the short period of time that primary care providers have to spend with their patients, [non-pharmacologic therapies are] often overlooked," said Dr. Hochberg.

For hand OA, the panel conditionally recommended evaluation of the patient’s ability to perform activities of daily living, instruction in joint protection techniques, assistive devices as needed, instruction in the use of thermal modalities, and splints for patients with trapeziometacarpal joint OA. Conditional pharmacologic recommendations for hand OA include topical capsaicin, topical nonsteroidal anti-inflammatory drugs (NSAIDs), and oral NSAIDs. The panel also conditionally recommended against the use of intra-articular therapies and opioid analgesics.

No strong recommendations were made for hand OA. "We only provided conditional recommendations for hand OA, which points to the relative dearth of studies in this area and then lack of good quality evidence to support treatments for it. Hand OA is an area that is in need of well-designed, large placebo-controlled and active-comparator studies," Dr. Hochberg commented.

For initial management of knee OA, the panel strongly recommended the nonpharmacologic interventions of participation in cardiovascular (aerobic) and/or resistance land-based exercise, participation in aquatic exercise, and weight loss if indicated. They conditionally recommended a long list of nonpharmacologic interventions, including participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial intervention, use of medially directed patellar taping, wedged insoles, thermal agents, walking aids as needed, participation in tai chi programs, treatment with Chinese acupuncture, and transcutaneous electrical stimulation.

No strong pharmacologic recommendations were made for the initial treatment of knee OA. Conditional recommendations included one of the following: acetaminophen, oral NSAIDs, topical NSAIDs, tramadol, or intra-articular corticosteroid injections. Conditional recommendations were made to not use chondroitin sulfate, glucosamine, or topical capsaicin.

Strong nonpharmacologic recommendations for hip OA included participation in cardiovascular and/or resistance land-based exercise, participation in aquatic exercise, and weight loss, if indicated. Conditional nonpharmacologic recommendations included participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial interventions, instruction in the use of thermal agents, and walking aids as needed.

As with knee OA, conditional pharmacologic recommendations for hip OA include one of either acetaminophen, oral NSAIDs, tramadol or intra-articular corticosteroid injections. As well, chondroitin sulfate and glucosamine were conditionally recommended against.

Dr. Hochberg acknowledged that despite the panel’s use of the rigorous evidence-based approach, the conditional recommendations for use of tai chi and acupuncture might prove controversial, as might the conditional recommendations against the use of intra-articular therapies for hand OA and glucosamine/chondroitin. The non-recommendation for the latter nutraceuticals was based on negative studies conducted on the products that are sold over the counter in the United States and Canada, which are different from the pharmaceutically produced preparations tested and sold in Europe, Dr. Hochberg explained.

Of note, there are no strong recommendations for pharmaceutical treatment of any joint area.

Dr. Hochberg disclosed that he has financial relationships with Abbott, Amgen, AstraZeneca, Bayer Health Care, Bioiberica, Bristol-Myers Squibb, CombinatoRx, Covidien, Eli Lilly, Genentech, GlaxoSmithKline, Hoffman-La Roche, Merck, Merck Serono International, NicOx, Novartis, Pfizer, Pozen, Rand Corporation, Sanofi-Aventis, Smith & Nephew, Stryker Biotech, Theralogix, TransPharma Medical, and UCB. He receives research support from the NIH.

The American College of Rheumatology’s latest recommendations on treatment of osteoarthritis place new emphasis on early use of nonpharmacologic therapies, such as tai chi and acupuncture and advise against use of glucosamine/chondroitin.

"We placed an emphasis on non-pharmacologic treatments. ... Reimbursement is one of the issues. We really wanted to put some gravitas on the evaluation of the non-pharmacologic modalities. ... We wanted providers to be aware of what’s available for patients, what’s beneficial for patients, and what the recommendations of a group of experts are on how they should use these for patients even before they consider pharmacologic agents."

The new recommendations, which are ACR’s first to address hand OA, are also the first to be developed using a formal process for evidence-based recommendations. They "were derived using a state-of-the-art approach utilizing evidence from the most recent and best methodological quality systematic review of the individual treatment modalities in patients with osteoarthritis of the hand, hip, or knee," lead author Dr. Marc C. Hochberg said in an interview.

The approach, called Grades of Recommendation Assessment, Development, and Evaluation (GRADE), has been adopted by the World Health Organization, the Cochrane Collaboration, and the Agency for Healthcare Research and Quality, along with numerous professional organizations. The American College of Rheumatology has now officially adopted GRADE for future recommendations, said Dr. Hochberg, professor of medicine and epidemiology and public health and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The new recommendations, which replace those issued in 2000, are also the first to be developed by a multidisciplinary panel that included primary care physicians, physiatrists, and geriatricians along with rheumatologists (both academic and private practice), an orthopedic surgeon, and both physical and occupational therapists. Based on the strength of the evidence and using real-life patient examples, the panelists ranked each recommendation as either strong in favor of use, weak (or conditional), no recommendation, weak or conditional recommendation not to use, and strong recommendation not to use (Arthritis Care Res. 2012;64:465-74).

"These are much more real-world recommendations based on patients who present for consultation and would be applicable for the provider in their office situation when they see a patient. ... They’re meant for primary care physicians as well as rheumatologists," Dr. Hochberg said.

In fact, the new emphasis on non-pharmacologic therapies is done for the benefit of primary care physicians. "In the short period of time that primary care providers have to spend with their patients, [non-pharmacologic therapies are] often overlooked," said Dr. Hochberg.

For hand OA, the panel conditionally recommended evaluation of the patient’s ability to perform activities of daily living, instruction in joint protection techniques, assistive devices as needed, instruction in the use of thermal modalities, and splints for patients with trapeziometacarpal joint OA. Conditional pharmacologic recommendations for hand OA include topical capsaicin, topical nonsteroidal anti-inflammatory drugs (NSAIDs), and oral NSAIDs. The panel also conditionally recommended against the use of intra-articular therapies and opioid analgesics.

No strong recommendations were made for hand OA. "We only provided conditional recommendations for hand OA, which points to the relative dearth of studies in this area and then lack of good quality evidence to support treatments for it. Hand OA is an area that is in need of well-designed, large placebo-controlled and active-comparator studies," Dr. Hochberg commented.

For initial management of knee OA, the panel strongly recommended the nonpharmacologic interventions of participation in cardiovascular (aerobic) and/or resistance land-based exercise, participation in aquatic exercise, and weight loss if indicated. They conditionally recommended a long list of nonpharmacologic interventions, including participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial intervention, use of medially directed patellar taping, wedged insoles, thermal agents, walking aids as needed, participation in tai chi programs, treatment with Chinese acupuncture, and transcutaneous electrical stimulation.

No strong pharmacologic recommendations were made for the initial treatment of knee OA. Conditional recommendations included one of the following: acetaminophen, oral NSAIDs, topical NSAIDs, tramadol, or intra-articular corticosteroid injections. Conditional recommendations were made to not use chondroitin sulfate, glucosamine, or topical capsaicin.

Strong nonpharmacologic recommendations for hip OA included participation in cardiovascular and/or resistance land-based exercise, participation in aquatic exercise, and weight loss, if indicated. Conditional nonpharmacologic recommendations included participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial interventions, instruction in the use of thermal agents, and walking aids as needed.

As with knee OA, conditional pharmacologic recommendations for hip OA include one of either acetaminophen, oral NSAIDs, tramadol or intra-articular corticosteroid injections. As well, chondroitin sulfate and glucosamine were conditionally recommended against.

Dr. Hochberg acknowledged that despite the panel’s use of the rigorous evidence-based approach, the conditional recommendations for use of tai chi and acupuncture might prove controversial, as might the conditional recommendations against the use of intra-articular therapies for hand OA and glucosamine/chondroitin. The non-recommendation for the latter nutraceuticals was based on negative studies conducted on the products that are sold over the counter in the United States and Canada, which are different from the pharmaceutically produced preparations tested and sold in Europe, Dr. Hochberg explained.

Of note, there are no strong recommendations for pharmaceutical treatment of any joint area.

Dr. Hochberg disclosed that he has financial relationships with Abbott, Amgen, AstraZeneca, Bayer Health Care, Bioiberica, Bristol-Myers Squibb, CombinatoRx, Covidien, Eli Lilly, Genentech, GlaxoSmithKline, Hoffman-La Roche, Merck, Merck Serono International, NicOx, Novartis, Pfizer, Pozen, Rand Corporation, Sanofi-Aventis, Smith & Nephew, Stryker Biotech, Theralogix, TransPharma Medical, and UCB. He receives research support from the NIH.

Can allergen-specific immunotherapy cut the risk of asthma development in children with allergic rhinitis? Dr. Linda Cox discusses the potential implications of an ongoing retrospective review of Florida Medicaid records to determine if immunotherapy reduced asthma risk and its associated costs.

Can allergen-specific immunotherapy cut the risk of asthma development in children with allergic rhinitis? Dr. Linda Cox discusses the potential implications of an ongoing retrospective review of Florida Medicaid records to determine if immunotherapy reduced asthma risk and its associated costs.

Can allergen-specific immunotherapy cut the risk of asthma development in children with allergic rhinitis? Dr. Linda Cox discusses the potential implications of an ongoing retrospective review of Florida Medicaid records to determine if immunotherapy reduced asthma risk and its associated costs.

Can allergen-specific immunotherapy cut the risk of asthma development in children with allergic rhinitis? Dr. Linda Cox discusses the potential implications of an ongoing retrospective review of Florida Medicaid records to determine if immunotherapy reduced asthma risk and its associated costs.

Can allergen-specific immunotherapy cut the risk of asthma development in children with allergic rhinitis? Dr. Linda Cox discusses the potential implications of an ongoing retrospective review of Florida Medicaid records to determine if immunotherapy reduced asthma risk and its associated costs.

Can allergen-specific immunotherapy cut the risk of asthma development in children with allergic rhinitis? Dr. Linda Cox discusses the potential implications of an ongoing retrospective review of Florida Medicaid records to determine if immunotherapy reduced asthma risk and its associated costs.

PHOENIX – Late oral effects of head and neck cancer therapy are "multiple, underreported, and underappreciated."

That is the perspective of Joel Epstein, D.M.D., who has worked extensively with head and neck cancer patients experiencing severe dental and other oral problems following radiation therapy.

"The acute complications of head and neck cancer therapy are pretty well known, but the late complications are underappreciated," Dr. Epstein, director of oral medicine at City of Hope National Medical Center, Duarte, Calif., told attendees at the symposium.

As head and neck cancer treatments have advanced and patients are living longer, the spectrum of treatment complications has shifted, he explained. In a 5-year, prospective longitudinal study of 122 patients with oral carcinoma, dry mouth, sticky saliva, speech changes, dental problems, and sleep disturbance were reported by all patients except those treated only with surgery. These complications persisted at 1 and 5 years and affected quality of life (Head Neck 2008;30:461-70).

According to Dr. Epstein, the data illustrate the need for better collaboration between oncologists and dentists. "While people discuss the concept of multidisciplinary [and] interdisciplinary teams for the benefit of our patients, it is unfortunate that dentistry developed separately from physicians and surgeons. So while we need to interact, we’re not really well prepared to do so, particularly in the community," he said.

Photos courtesy Dr. Joel Epstein

Clinically, it’s important to evaluate oral care, including brushing, flossing, fluoride, and tobacco abstinence, at all head and neck cancer treatment follow-up visits. Patients should be assessed for xerostomia, speech, swallowing, mucosal sensitivity, and taste. Head and neck and oral exams should include assessments for saliva (wet mucosa), exposed bone, infection, and new lesions or recurrent cancer, and a dental exam (for plaque, caries, and periodontal health), Dr. Epstein recommended.

Dry mouth, in particular, can lead to a host of other chronic problems related to swallowing, eating, sleeping, and dental health. When the 50-item Vanderbilt Head and Neck Symptom Survey was administered to a total of 70 patients, 67 reported having dry mouth at more than 6 months’ follow up (Head Neck 2011 Aug. 24 [doi:10.1002/hed.21816]).

The majority reported that dry mouth makes chewing/swallowing difficult (65) and that it affects their ability to sleep (67) and talk (64). With regard to eating and swallowing, similar majorities reported trouble eating solids (67) and drinking liquids (68), with food getting stuck in their mouth (66) and throat (67).

And, of concern, the same numbers of patients reported the sensation of choking or strangling on solids (66) and liquids (68). "The impact on function from the lack of saliva and the change in quality of saliva are issues we need to be more ready and willing to address," Dr. Epstein commented.

Taste and smell may also be profoundly altered. In the Vanderbilt survey, most patients reported altered taste (68), a decreased desire to eat (68), altered food choices (66), and a decrease in food eaten (66). A change in sense of smell was reported by 69 patients.

Such alterations often result in changes in diet, including decreased consumption of high-fiber food and of vitamins and other nutrients, along with increased consumption of fats, caffeine, and sugar. All of these factors increase the risk for dietary deficiencies, as well as dental caries.

Yet, altered taste sensation is not something patients might think to mention. "Half of patients experience altered taste sensation. But if they think you’re not interested or you don’t ask, you may not know," Dr. Epstein commented.

Periodontal health is often compromised by hyposalivation, which can lead to inflammation, bone/attachment loss, oral infection, and necrosis. Dental demineralization and cavitation may develop as early as 2-3 months after cancer treatment and progress rapidly, leading to fractures of the gum line, tooth loss, and necrosis.

Demineralization appears as a change to white, which may not be recognized as a problem because of the belief that white teeth are healthy. However, recognition at this stage is critical in order to prevent further dental damage, he said.

"The white change near the gum line and the tips of the teeth represent demineralization, and [in] time reversal can be accomplished prior to structural breakdown. Once cavitation has occurred, fillings are needed and prevention must be instituted or the cavities will recur and progress," Dr. Epstein said in an interview.

In the Vanderbilt survey, reported dental problems included difficulty chewing because of teeth/dentures (54 of the 70 patients); tooth sensitivity to hot, cold, or sweet foods (52); teeth feeling looser (51); teeth cracking/chipping (50); and trouble with dentures (24).

Oral candidiasis is another common problem, affecting approximately 39% of head and neck cancer patients during treatment and 33% afterward. One common clinical mistake is prescribing these patients antifungals that contain sugar, such as nystatin. "Nystatin is very high in sugar, and one of the [most commonly] used antifungals. The message is to avoid sugar-sweetened products in dry mouth patients and utilize alternatives," Dr. Epstein said in the interview.

Mucosal sensitivity and pain is also frequent. In a meta-analysis of 22 studies published between 1990 and 2008, the prevalence of trismus was 25.4% in patients who received conventional radiotherapy and 5% for the few intensity-modulated radiation therapy studies that were included, suggesting that the newer radiation modality might diminish the problem (Support. Care Cancer 2010;18:1033-8).

Data suggest that the radiation effect on mandibular movement correlates with the radiation dose to the mastication muscles, with a steep dose-response curve. Onset is typically 2-6 months post treatment and is ongoing. Concurrent chemotherapy may increase the incidence and/or severity of mandibular immobility (Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 1999;88:365-73).

In the Vanderbilt survey, most patients reported burning in the throat or mouth (69); sensitivity to hot, spicy, or acid food (67); sensitivity to dryness (69); and changes in food intake because of mucosal sensitivity (67); most patients also reported that mucosal sensitivity prevents tooth brushing (63). "Mucosal sensitivity is a quality of life issue," Dr. Epstein said.

The Vanderbilt survey was particularly illuminating, Dr. Epstein commented. Studies that utilize claims data probably underrepresent the problem of long-term oral complications because dental and medical insurance are separate and the data are not easily combined, he added.

"Late oral effects are best diagnosed [and] managed in a multidisciplinary team with close communication between medical and dental providers. ... We really need to come together."

The Multinational Association of Supportive Care in Cancer is developing tools to improve communication between dentistry and medicine. These could be available for beta testing as early as this fall.

Dr. Epstein said he had no relevant financial disclosures.

PHOENIX – Late oral effects of head and neck cancer therapy are "multiple, underreported, and underappreciated."

That is the perspective of Joel Epstein, D.M.D., who has worked extensively with head and neck cancer patients experiencing severe dental and other oral problems following radiation therapy.

"The acute complications of head and neck cancer therapy are pretty well known, but the late complications are underappreciated," Dr. Epstein, director of oral medicine at City of Hope National Medical Center, Duarte, Calif., told attendees at the symposium.

As head and neck cancer treatments have advanced and patients are living longer, the spectrum of treatment complications has shifted, he explained. In a 5-year, prospective longitudinal study of 122 patients with oral carcinoma, dry mouth, sticky saliva, speech changes, dental problems, and sleep disturbance were reported by all patients except those treated only with surgery. These complications persisted at 1 and 5 years and affected quality of life (Head Neck 2008;30:461-70).

According to Dr. Epstein, the data illustrate the need for better collaboration between oncologists and dentists. "While people discuss the concept of multidisciplinary [and] interdisciplinary teams for the benefit of our patients, it is unfortunate that dentistry developed separately from physicians and surgeons. So while we need to interact, we’re not really well prepared to do so, particularly in the community," he said.

Photos courtesy Dr. Joel Epstein

Clinically, it’s important to evaluate oral care, including brushing, flossing, fluoride, and tobacco abstinence, at all head and neck cancer treatment follow-up visits. Patients should be assessed for xerostomia, speech, swallowing, mucosal sensitivity, and taste. Head and neck and oral exams should include assessments for saliva (wet mucosa), exposed bone, infection, and new lesions or recurrent cancer, and a dental exam (for plaque, caries, and periodontal health), Dr. Epstein recommended.

Dry mouth, in particular, can lead to a host of other chronic problems related to swallowing, eating, sleeping, and dental health. When the 50-item Vanderbilt Head and Neck Symptom Survey was administered to a total of 70 patients, 67 reported having dry mouth at more than 6 months’ follow up (Head Neck 2011 Aug. 24 [doi:10.1002/hed.21816]).

The majority reported that dry mouth makes chewing/swallowing difficult (65) and that it affects their ability to sleep (67) and talk (64). With regard to eating and swallowing, similar majorities reported trouble eating solids (67) and drinking liquids (68), with food getting stuck in their mouth (66) and throat (67).

And, of concern, the same numbers of patients reported the sensation of choking or strangling on solids (66) and liquids (68). "The impact on function from the lack of saliva and the change in quality of saliva are issues we need to be more ready and willing to address," Dr. Epstein commented.

Taste and smell may also be profoundly altered. In the Vanderbilt survey, most patients reported altered taste (68), a decreased desire to eat (68), altered food choices (66), and a decrease in food eaten (66). A change in sense of smell was reported by 69 patients.

Such alterations often result in changes in diet, including decreased consumption of high-fiber food and of vitamins and other nutrients, along with increased consumption of fats, caffeine, and sugar. All of these factors increase the risk for dietary deficiencies, as well as dental caries.

Yet, altered taste sensation is not something patients might think to mention. "Half of patients experience altered taste sensation. But if they think you’re not interested or you don’t ask, you may not know," Dr. Epstein commented.

Periodontal health is often compromised by hyposalivation, which can lead to inflammation, bone/attachment loss, oral infection, and necrosis. Dental demineralization and cavitation may develop as early as 2-3 months after cancer treatment and progress rapidly, leading to fractures of the gum line, tooth loss, and necrosis.

Demineralization appears as a change to white, which may not be recognized as a problem because of the belief that white teeth are healthy. However, recognition at this stage is critical in order to prevent further dental damage, he said.

"The white change near the gum line and the tips of the teeth represent demineralization, and [in] time reversal can be accomplished prior to structural breakdown. Once cavitation has occurred, fillings are needed and prevention must be instituted or the cavities will recur and progress," Dr. Epstein said in an interview.

In the Vanderbilt survey, reported dental problems included difficulty chewing because of teeth/dentures (54 of the 70 patients); tooth sensitivity to hot, cold, or sweet foods (52); teeth feeling looser (51); teeth cracking/chipping (50); and trouble with dentures (24).

Oral candidiasis is another common problem, affecting approximately 39% of head and neck cancer patients during treatment and 33% afterward. One common clinical mistake is prescribing these patients antifungals that contain sugar, such as nystatin. "Nystatin is very high in sugar, and one of the [most commonly] used antifungals. The message is to avoid sugar-sweetened products in dry mouth patients and utilize alternatives," Dr. Epstein said in the interview.

Mucosal sensitivity and pain is also frequent. In a meta-analysis of 22 studies published between 1990 and 2008, the prevalence of trismus was 25.4% in patients who received conventional radiotherapy and 5% for the few intensity-modulated radiation therapy studies that were included, suggesting that the newer radiation modality might diminish the problem (Support. Care Cancer 2010;18:1033-8).

Data suggest that the radiation effect on mandibular movement correlates with the radiation dose to the mastication muscles, with a steep dose-response curve. Onset is typically 2-6 months post treatment and is ongoing. Concurrent chemotherapy may increase the incidence and/or severity of mandibular immobility (Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 1999;88:365-73).

In the Vanderbilt survey, most patients reported burning in the throat or mouth (69); sensitivity to hot, spicy, or acid food (67); sensitivity to dryness (69); and changes in food intake because of mucosal sensitivity (67); most patients also reported that mucosal sensitivity prevents tooth brushing (63). "Mucosal sensitivity is a quality of life issue," Dr. Epstein said.

The Vanderbilt survey was particularly illuminating, Dr. Epstein commented. Studies that utilize claims data probably underrepresent the problem of long-term oral complications because dental and medical insurance are separate and the data are not easily combined, he added.

"Late oral effects are best diagnosed [and] managed in a multidisciplinary team with close communication between medical and dental providers. ... We really need to come together."

The Multinational Association of Supportive Care in Cancer is developing tools to improve communication between dentistry and medicine. These could be available for beta testing as early as this fall.

Dr. Epstein said he had no relevant financial disclosures.

PHOENIX – Late oral effects of head and neck cancer therapy are "multiple, underreported, and underappreciated."

That is the perspective of Joel Epstein, D.M.D., who has worked extensively with head and neck cancer patients experiencing severe dental and other oral problems following radiation therapy.

"The acute complications of head and neck cancer therapy are pretty well known, but the late complications are underappreciated," Dr. Epstein, director of oral medicine at City of Hope National Medical Center, Duarte, Calif., told attendees at the symposium.

As head and neck cancer treatments have advanced and patients are living longer, the spectrum of treatment complications has shifted, he explained. In a 5-year, prospective longitudinal study of 122 patients with oral carcinoma, dry mouth, sticky saliva, speech changes, dental problems, and sleep disturbance were reported by all patients except those treated only with surgery. These complications persisted at 1 and 5 years and affected quality of life (Head Neck 2008;30:461-70).

According to Dr. Epstein, the data illustrate the need for better collaboration between oncologists and dentists. "While people discuss the concept of multidisciplinary [and] interdisciplinary teams for the benefit of our patients, it is unfortunate that dentistry developed separately from physicians and surgeons. So while we need to interact, we’re not really well prepared to do so, particularly in the community," he said.

Photos courtesy Dr. Joel Epstein

Clinically, it’s important to evaluate oral care, including brushing, flossing, fluoride, and tobacco abstinence, at all head and neck cancer treatment follow-up visits. Patients should be assessed for xerostomia, speech, swallowing, mucosal sensitivity, and taste. Head and neck and oral exams should include assessments for saliva (wet mucosa), exposed bone, infection, and new lesions or recurrent cancer, and a dental exam (for plaque, caries, and periodontal health), Dr. Epstein recommended.

Dry mouth, in particular, can lead to a host of other chronic problems related to swallowing, eating, sleeping, and dental health. When the 50-item Vanderbilt Head and Neck Symptom Survey was administered to a total of 70 patients, 67 reported having dry mouth at more than 6 months’ follow up (Head Neck 2011 Aug. 24 [doi:10.1002/hed.21816]).

The majority reported that dry mouth makes chewing/swallowing difficult (65) and that it affects their ability to sleep (67) and talk (64). With regard to eating and swallowing, similar majorities reported trouble eating solids (67) and drinking liquids (68), with food getting stuck in their mouth (66) and throat (67).

And, of concern, the same numbers of patients reported the sensation of choking or strangling on solids (66) and liquids (68). "The impact on function from the lack of saliva and the change in quality of saliva are issues we need to be more ready and willing to address," Dr. Epstein commented.

Taste and smell may also be profoundly altered. In the Vanderbilt survey, most patients reported altered taste (68), a decreased desire to eat (68), altered food choices (66), and a decrease in food eaten (66). A change in sense of smell was reported by 69 patients.

Such alterations often result in changes in diet, including decreased consumption of high-fiber food and of vitamins and other nutrients, along with increased consumption of fats, caffeine, and sugar. All of these factors increase the risk for dietary deficiencies, as well as dental caries.

Yet, altered taste sensation is not something patients might think to mention. "Half of patients experience altered taste sensation. But if they think you’re not interested or you don’t ask, you may not know," Dr. Epstein commented.

Periodontal health is often compromised by hyposalivation, which can lead to inflammation, bone/attachment loss, oral infection, and necrosis. Dental demineralization and cavitation may develop as early as 2-3 months after cancer treatment and progress rapidly, leading to fractures of the gum line, tooth loss, and necrosis.

Demineralization appears as a change to white, which may not be recognized as a problem because of the belief that white teeth are healthy. However, recognition at this stage is critical in order to prevent further dental damage, he said.

"The white change near the gum line and the tips of the teeth represent demineralization, and [in] time reversal can be accomplished prior to structural breakdown. Once cavitation has occurred, fillings are needed and prevention must be instituted or the cavities will recur and progress," Dr. Epstein said in an interview.

In the Vanderbilt survey, reported dental problems included difficulty chewing because of teeth/dentures (54 of the 70 patients); tooth sensitivity to hot, cold, or sweet foods (52); teeth feeling looser (51); teeth cracking/chipping (50); and trouble with dentures (24).

Oral candidiasis is another common problem, affecting approximately 39% of head and neck cancer patients during treatment and 33% afterward. One common clinical mistake is prescribing these patients antifungals that contain sugar, such as nystatin. "Nystatin is very high in sugar, and one of the [most commonly] used antifungals. The message is to avoid sugar-sweetened products in dry mouth patients and utilize alternatives," Dr. Epstein said in the interview.

Mucosal sensitivity and pain is also frequent. In a meta-analysis of 22 studies published between 1990 and 2008, the prevalence of trismus was 25.4% in patients who received conventional radiotherapy and 5% for the few intensity-modulated radiation therapy studies that were included, suggesting that the newer radiation modality might diminish the problem (Support. Care Cancer 2010;18:1033-8).

Data suggest that the radiation effect on mandibular movement correlates with the radiation dose to the mastication muscles, with a steep dose-response curve. Onset is typically 2-6 months post treatment and is ongoing. Concurrent chemotherapy may increase the incidence and/or severity of mandibular immobility (Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 1999;88:365-73).

In the Vanderbilt survey, most patients reported burning in the throat or mouth (69); sensitivity to hot, spicy, or acid food (67); sensitivity to dryness (69); and changes in food intake because of mucosal sensitivity (67); most patients also reported that mucosal sensitivity prevents tooth brushing (63). "Mucosal sensitivity is a quality of life issue," Dr. Epstein said.

The Vanderbilt survey was particularly illuminating, Dr. Epstein commented. Studies that utilize claims data probably underrepresent the problem of long-term oral complications because dental and medical insurance are separate and the data are not easily combined, he added.

"Late oral effects are best diagnosed [and] managed in a multidisciplinary team with close communication between medical and dental providers. ... We really need to come together."

The Multinational Association of Supportive Care in Cancer is developing tools to improve communication between dentistry and medicine. These could be available for beta testing as early as this fall.

Dr. Epstein said he had no relevant financial disclosures.