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Leflunomide-Rituximab Combo Effective in RA
Major Finding: More patients achieved a EULAR good response at 6 months and 12 months when treated with leflunomide along with rituximab (and also had a lower incidence of retreatment) than did patients who were treated with methotrexate plus rituximab, or rituximab alone.
Data Source: A population study based on analysis of data from 10 European registries.
Disclosures: Dr. Gabay said he has no conflicts of interest relevant to this study. The CERERRA collaboration (of which the European registries are a part) that was mentioned in the story is described by Dr. Gabay as an investigator-led, industry-supported initiative that was formed to evaluate the clinical aspects of rituximab use for RA. This analysis and study abstract were prepared, “without any influence from the supporting medical industry,” Dr. Gabay said.
Leflunomide is an effective concomitant treatment with rituximab in patients with rheumatoid arthritis, according to findings from a population-based study.
In fact, “a combination of leflunomide and rituximab is probably better than a combination of methotrexate and rituximab,” said Dr. Cem Gabay of the University Hospitals of Geneva in an interview with Rheumatology News.
Ten European registries that are participating in the CERERRA collaboration submitted data sets for patients who were treated with rituximab, and more than 1,900 patients were analyzed for their response to treatment with one of three therapeutic approaches: rituximab with either methotrexate (MTX) or leflunomide (LEF), or rituximab alone. Significantly more patients achieved a EULAR good response at 6 months when treated with rituximab and LEF (33%), compared with rituximab and MTX (21%) or with rituximab alone (20%).
A similar trend was observed at 12 months. Fewer patients, moreover, were retreated during the first 12 months when they received LEF (11% in the rituximab plus LEF group vs. 20% in the rituximab plus MTX group and 19% among those on rituximab monotherapy).
A univariate analysis adjusted for age and sex showed that patients who received LEF in combination with rituximab were 2.6 times more likely to have a good EULAR response at 6 months than were patients who received MTX plus rituximab. They were also three times more likely to have a good EULAR response at 6 months than were patients who received rituximab monotherapy. At 12 months, patients who received LEF as a combination therapy were about twice as likely to have a good EULAR response as were patients in the other groups.
Combination therapy with LEF was still predictive of a good EULAR response in a multivariate analysis that took into account factors like disease duration and the number of previous biologic agents used.
“This is a population-based study, so we need to be cautious about the conclusions we draw from the data,” said Dr. Gabay. Among the study's limitations are the lack of randomization and control. The Food and Drug Administration recently required that the leflunomide label contain a Boxed Warning about severe liver injury.
To see an interview with Dr. Cem Gabay, go to
Source Heidi Splete/Elsevier Global Medical Newswww.youtube.com/elsglobalmedical
Major Finding: More patients achieved a EULAR good response at 6 months and 12 months when treated with leflunomide along with rituximab (and also had a lower incidence of retreatment) than did patients who were treated with methotrexate plus rituximab, or rituximab alone.
Data Source: A population study based on analysis of data from 10 European registries.
Disclosures: Dr. Gabay said he has no conflicts of interest relevant to this study. The CERERRA collaboration (of which the European registries are a part) that was mentioned in the story is described by Dr. Gabay as an investigator-led, industry-supported initiative that was formed to evaluate the clinical aspects of rituximab use for RA. This analysis and study abstract were prepared, “without any influence from the supporting medical industry,” Dr. Gabay said.
Leflunomide is an effective concomitant treatment with rituximab in patients with rheumatoid arthritis, according to findings from a population-based study.
In fact, “a combination of leflunomide and rituximab is probably better than a combination of methotrexate and rituximab,” said Dr. Cem Gabay of the University Hospitals of Geneva in an interview with Rheumatology News.
Ten European registries that are participating in the CERERRA collaboration submitted data sets for patients who were treated with rituximab, and more than 1,900 patients were analyzed for their response to treatment with one of three therapeutic approaches: rituximab with either methotrexate (MTX) or leflunomide (LEF), or rituximab alone. Significantly more patients achieved a EULAR good response at 6 months when treated with rituximab and LEF (33%), compared with rituximab and MTX (21%) or with rituximab alone (20%).
A similar trend was observed at 12 months. Fewer patients, moreover, were retreated during the first 12 months when they received LEF (11% in the rituximab plus LEF group vs. 20% in the rituximab plus MTX group and 19% among those on rituximab monotherapy).
A univariate analysis adjusted for age and sex showed that patients who received LEF in combination with rituximab were 2.6 times more likely to have a good EULAR response at 6 months than were patients who received MTX plus rituximab. They were also three times more likely to have a good EULAR response at 6 months than were patients who received rituximab monotherapy. At 12 months, patients who received LEF as a combination therapy were about twice as likely to have a good EULAR response as were patients in the other groups.
Combination therapy with LEF was still predictive of a good EULAR response in a multivariate analysis that took into account factors like disease duration and the number of previous biologic agents used.
“This is a population-based study, so we need to be cautious about the conclusions we draw from the data,” said Dr. Gabay. Among the study's limitations are the lack of randomization and control. The Food and Drug Administration recently required that the leflunomide label contain a Boxed Warning about severe liver injury.
To see an interview with Dr. Cem Gabay, go to
Source Heidi Splete/Elsevier Global Medical Newswww.youtube.com/elsglobalmedical
Major Finding: More patients achieved a EULAR good response at 6 months and 12 months when treated with leflunomide along with rituximab (and also had a lower incidence of retreatment) than did patients who were treated with methotrexate plus rituximab, or rituximab alone.
Data Source: A population study based on analysis of data from 10 European registries.
Disclosures: Dr. Gabay said he has no conflicts of interest relevant to this study. The CERERRA collaboration (of which the European registries are a part) that was mentioned in the story is described by Dr. Gabay as an investigator-led, industry-supported initiative that was formed to evaluate the clinical aspects of rituximab use for RA. This analysis and study abstract were prepared, “without any influence from the supporting medical industry,” Dr. Gabay said.
Leflunomide is an effective concomitant treatment with rituximab in patients with rheumatoid arthritis, according to findings from a population-based study.
In fact, “a combination of leflunomide and rituximab is probably better than a combination of methotrexate and rituximab,” said Dr. Cem Gabay of the University Hospitals of Geneva in an interview with Rheumatology News.
Ten European registries that are participating in the CERERRA collaboration submitted data sets for patients who were treated with rituximab, and more than 1,900 patients were analyzed for their response to treatment with one of three therapeutic approaches: rituximab with either methotrexate (MTX) or leflunomide (LEF), or rituximab alone. Significantly more patients achieved a EULAR good response at 6 months when treated with rituximab and LEF (33%), compared with rituximab and MTX (21%) or with rituximab alone (20%).
A similar trend was observed at 12 months. Fewer patients, moreover, were retreated during the first 12 months when they received LEF (11% in the rituximab plus LEF group vs. 20% in the rituximab plus MTX group and 19% among those on rituximab monotherapy).
A univariate analysis adjusted for age and sex showed that patients who received LEF in combination with rituximab were 2.6 times more likely to have a good EULAR response at 6 months than were patients who received MTX plus rituximab. They were also three times more likely to have a good EULAR response at 6 months than were patients who received rituximab monotherapy. At 12 months, patients who received LEF as a combination therapy were about twice as likely to have a good EULAR response as were patients in the other groups.
Combination therapy with LEF was still predictive of a good EULAR response in a multivariate analysis that took into account factors like disease duration and the number of previous biologic agents used.
“This is a population-based study, so we need to be cautious about the conclusions we draw from the data,” said Dr. Gabay. Among the study's limitations are the lack of randomization and control. The Food and Drug Administration recently required that the leflunomide label contain a Boxed Warning about severe liver injury.
To see an interview with Dr. Cem Gabay, go to
Source Heidi Splete/Elsevier Global Medical Newswww.youtube.com/elsglobalmedical
Hand OA Atlas Moves Scoring System Forward
Major Finding: Osteophytosis was the dominant pathology in more than 3,700 hand joints examined by ultrasound in patients with hand OA.
Data Source: A descriptive imaging study of 127 patients with hand OA.
Disclosures: Dr. Hammer was supported by an unrestricted grant from Abbott Laboratories; this grant was given after the study was completed, however, according to Mr. Mathiessen. Mr. Mathiessen said they have no disclosures or conflicts of interest to report related to this study.
Investigators who are developing an ultrasound “atlas” of hand osteoarthritis hope that their collection of images will aid in the development of a standardized ultrasonographic scoring system for the disease.
The investigators' descriptive study of ultrasonographic findings in 127 patients builds upon the development several years ago of a preliminary ultrasonographic scoring system for the features of hand osteoarthritis.
In the prior effort, reported in 2008 in the Annals of the Rheumatic Diseases, experts led by Dr. Helen Keen of the University of Leeds (England) reached consensus on which ultrasound-detectable abnormalities—synovitis (gray scale and power Doppler) and osteophytes—are important and feasible for inclusion in a scoring system.
The new atlas of characteristic images of osteoarthritis in finger joints takes the effort a step further, “so that we can realize the full potential of ultrasound” as an imaging tool for hand OA, and “move toward validating the preliminary semiquantitative scoring system” for use in epidemiologic and outcome studies, said Alexander Mathiessen, a medical student at the University of Oslo.
The 127 patients who were examined with ultrasound had a mean age of 69 years and symptom duration of approximately 18 years. Two sonographers performed the assessments together and, using a 0-3 scale, achieved consensus in the scoring of osteophytes, gray-scale synovitis, and power Doppler in 30 joints: the first carpometacarpal (CMC), first through fifth metacarpophalangeal (MCP), first through fifth proximal interphalangeal (PIP), second through fifth distal interphalangeal (DIP), dorsal view, from radial to ulnar side bilaterally.
Osteophytosis has been the dominant pathology in the approximately 3,700 joints examined thus far, with a prevalence of 53%. All patients had osteophytes in at least four joints. In joints with osteophyte pathology, the mean scores were 1.8 for CMC, 1.2 for MCP, 1.8 for PIP, and 2.1 for DIP joints.
The imaging study, which Mr. Mathiessen performed with Dr. Hilde B. Hammer at the Diakonhjemmet Hospital in Oslo, revealed a large degree of symmetry between hands—a finding that confirms what other studies have shown, he noted.
“Hand osteoarthritis is remarkably symmetric,” said Mr. Mathiessen. “The odds ratio of having an osteophyte in one joint if you have it in the same opposite joint was 35.1, indicating significant concordance.”
And in another finding that “needs further evaluation,” the investigators found that in 84% of the patients, the sum osteophyte score was similar or greater in the dominant hand than in the nondominant hand. “It [may be] enough to scan only the dominant hand,” he observed.
Gray-scale synovitis and power Doppler activity were found in approximately 16% and 2% of the joints, respectively.
“We found synovitis in one-third of the CMC joints, though, and in about 20% of the small PIP and DIP joints,” Mr. Mathiessen said. “Power Doppler was frequent only in the CMC joint, with a prevalence of 14%.”
The findings might indicate “that the focus should be on osteophytes and synovitis,” he added. “Based on our findings, I'm not sure about the role of power Doppler in a final scoring system…. On the other hand, though, this feature is important for differentiating osteoarthritis against other joint diseases.”
Ultrasound images of hands affected by osteoarthritis, such as the Doppler image above, compose the OMERACT atlas.
Source Courtesy Alexander Mathiessen
Major Finding: Osteophytosis was the dominant pathology in more than 3,700 hand joints examined by ultrasound in patients with hand OA.
Data Source: A descriptive imaging study of 127 patients with hand OA.
Disclosures: Dr. Hammer was supported by an unrestricted grant from Abbott Laboratories; this grant was given after the study was completed, however, according to Mr. Mathiessen. Mr. Mathiessen said they have no disclosures or conflicts of interest to report related to this study.
Investigators who are developing an ultrasound “atlas” of hand osteoarthritis hope that their collection of images will aid in the development of a standardized ultrasonographic scoring system for the disease.
The investigators' descriptive study of ultrasonographic findings in 127 patients builds upon the development several years ago of a preliminary ultrasonographic scoring system for the features of hand osteoarthritis.
In the prior effort, reported in 2008 in the Annals of the Rheumatic Diseases, experts led by Dr. Helen Keen of the University of Leeds (England) reached consensus on which ultrasound-detectable abnormalities—synovitis (gray scale and power Doppler) and osteophytes—are important and feasible for inclusion in a scoring system.
The new atlas of characteristic images of osteoarthritis in finger joints takes the effort a step further, “so that we can realize the full potential of ultrasound” as an imaging tool for hand OA, and “move toward validating the preliminary semiquantitative scoring system” for use in epidemiologic and outcome studies, said Alexander Mathiessen, a medical student at the University of Oslo.
The 127 patients who were examined with ultrasound had a mean age of 69 years and symptom duration of approximately 18 years. Two sonographers performed the assessments together and, using a 0-3 scale, achieved consensus in the scoring of osteophytes, gray-scale synovitis, and power Doppler in 30 joints: the first carpometacarpal (CMC), first through fifth metacarpophalangeal (MCP), first through fifth proximal interphalangeal (PIP), second through fifth distal interphalangeal (DIP), dorsal view, from radial to ulnar side bilaterally.
Osteophytosis has been the dominant pathology in the approximately 3,700 joints examined thus far, with a prevalence of 53%. All patients had osteophytes in at least four joints. In joints with osteophyte pathology, the mean scores were 1.8 for CMC, 1.2 for MCP, 1.8 for PIP, and 2.1 for DIP joints.
The imaging study, which Mr. Mathiessen performed with Dr. Hilde B. Hammer at the Diakonhjemmet Hospital in Oslo, revealed a large degree of symmetry between hands—a finding that confirms what other studies have shown, he noted.
“Hand osteoarthritis is remarkably symmetric,” said Mr. Mathiessen. “The odds ratio of having an osteophyte in one joint if you have it in the same opposite joint was 35.1, indicating significant concordance.”
And in another finding that “needs further evaluation,” the investigators found that in 84% of the patients, the sum osteophyte score was similar or greater in the dominant hand than in the nondominant hand. “It [may be] enough to scan only the dominant hand,” he observed.
Gray-scale synovitis and power Doppler activity were found in approximately 16% and 2% of the joints, respectively.
“We found synovitis in one-third of the CMC joints, though, and in about 20% of the small PIP and DIP joints,” Mr. Mathiessen said. “Power Doppler was frequent only in the CMC joint, with a prevalence of 14%.”
The findings might indicate “that the focus should be on osteophytes and synovitis,” he added. “Based on our findings, I'm not sure about the role of power Doppler in a final scoring system…. On the other hand, though, this feature is important for differentiating osteoarthritis against other joint diseases.”
Ultrasound images of hands affected by osteoarthritis, such as the Doppler image above, compose the OMERACT atlas.
Source Courtesy Alexander Mathiessen
Major Finding: Osteophytosis was the dominant pathology in more than 3,700 hand joints examined by ultrasound in patients with hand OA.
Data Source: A descriptive imaging study of 127 patients with hand OA.
Disclosures: Dr. Hammer was supported by an unrestricted grant from Abbott Laboratories; this grant was given after the study was completed, however, according to Mr. Mathiessen. Mr. Mathiessen said they have no disclosures or conflicts of interest to report related to this study.
Investigators who are developing an ultrasound “atlas” of hand osteoarthritis hope that their collection of images will aid in the development of a standardized ultrasonographic scoring system for the disease.
The investigators' descriptive study of ultrasonographic findings in 127 patients builds upon the development several years ago of a preliminary ultrasonographic scoring system for the features of hand osteoarthritis.
In the prior effort, reported in 2008 in the Annals of the Rheumatic Diseases, experts led by Dr. Helen Keen of the University of Leeds (England) reached consensus on which ultrasound-detectable abnormalities—synovitis (gray scale and power Doppler) and osteophytes—are important and feasible for inclusion in a scoring system.
The new atlas of characteristic images of osteoarthritis in finger joints takes the effort a step further, “so that we can realize the full potential of ultrasound” as an imaging tool for hand OA, and “move toward validating the preliminary semiquantitative scoring system” for use in epidemiologic and outcome studies, said Alexander Mathiessen, a medical student at the University of Oslo.
The 127 patients who were examined with ultrasound had a mean age of 69 years and symptom duration of approximately 18 years. Two sonographers performed the assessments together and, using a 0-3 scale, achieved consensus in the scoring of osteophytes, gray-scale synovitis, and power Doppler in 30 joints: the first carpometacarpal (CMC), first through fifth metacarpophalangeal (MCP), first through fifth proximal interphalangeal (PIP), second through fifth distal interphalangeal (DIP), dorsal view, from radial to ulnar side bilaterally.
Osteophytosis has been the dominant pathology in the approximately 3,700 joints examined thus far, with a prevalence of 53%. All patients had osteophytes in at least four joints. In joints with osteophyte pathology, the mean scores were 1.8 for CMC, 1.2 for MCP, 1.8 for PIP, and 2.1 for DIP joints.
The imaging study, which Mr. Mathiessen performed with Dr. Hilde B. Hammer at the Diakonhjemmet Hospital in Oslo, revealed a large degree of symmetry between hands—a finding that confirms what other studies have shown, he noted.
“Hand osteoarthritis is remarkably symmetric,” said Mr. Mathiessen. “The odds ratio of having an osteophyte in one joint if you have it in the same opposite joint was 35.1, indicating significant concordance.”
And in another finding that “needs further evaluation,” the investigators found that in 84% of the patients, the sum osteophyte score was similar or greater in the dominant hand than in the nondominant hand. “It [may be] enough to scan only the dominant hand,” he observed.
Gray-scale synovitis and power Doppler activity were found in approximately 16% and 2% of the joints, respectively.
“We found synovitis in one-third of the CMC joints, though, and in about 20% of the small PIP and DIP joints,” Mr. Mathiessen said. “Power Doppler was frequent only in the CMC joint, with a prevalence of 14%.”
The findings might indicate “that the focus should be on osteophytes and synovitis,” he added. “Based on our findings, I'm not sure about the role of power Doppler in a final scoring system…. On the other hand, though, this feature is important for differentiating osteoarthritis against other joint diseases.”
Ultrasound images of hands affected by osteoarthritis, such as the Doppler image above, compose the OMERACT atlas.
Source Courtesy Alexander Mathiessen
Stress in Pregnancy May Raise Child's Risk for Asthma
Prenatal stress is associated with altered patterns of cord blood cytokine production that may raise a child's asthma risk later in life, according to findings of one study.
“Prenatal stress appears to affect immune responses to both innate and adaptive stimuli at the time of birth—effects that may result in enhanced susceptibility to asthma or other atopic disorders,” said Dr. Rosalind J. Wright of Harvard Medical School in Boston and her associates (Am. J. Respir. Crit. Care Med. 2010 March 1 [doi:10.1164/rccm.200904-0637OC
The findings on seemingly stress-induced perinatal immune modulation may offer some new insight into the disproportionately high prevalence of asthma among ethnic minorities and disadvantaged urban communities.
In a prospective birth cohort study of urban, largely minority women, the investigators collected cord blood at birth and examined cord blood mononuclear cell (CBMC) cytokine responses to various innate and adaptive stimuli. Cytokine responses to both types of stimuli were significantly different in babies born to mothers with high levels of reported cumulative stress, compared with babies born to lower-stressed mothers.
In each case, the infants were at high risk for atopic diseases based on family history; either the mother or father had a history of asthma or allergy. Higher prenatal stress was related to increased production of interleukin-8 (IL-8) and tumor necrosis factor–alpha, for example, following microbial (CpG, PIC) stimuli.
For adaptive response, there was evidence that higher stress is tied to lower levels of interferon-gamma production in response to stimulation with PHA (a nonspecific mitogen), which has been linked to an increased risk for later atopic disease. Higher stress was also linked with an increased IL-13 response to dust mite antigen, which has been associated with allergic sensitization in older children.
The investigators studied 560 newborns and their mothers who live in Baltimore, Boston, New York, and St. Louis, and who were participating in the Urban Environment and Childhood Asthma Study. The mothers were primarily minorities (71% black and 19% Hispanic); 69% reported an annual income of less than $15,000.
Families answered detailed questions about various stressors in their lives, including financial hardship, community violence, and neighborhood and housing conditions.
The cohort will continue to be followed, enabling further assessment of the effects of prenatal and postnatal stress on infant immune development, and clinical outcomes, as the infants grow.
Disclosures: The study received funding from the National Institutes of Health. Dr. Wright also received funding from an NIH grant.
Prenatal stress is associated with altered patterns of cord blood cytokine production that may raise a child's asthma risk later in life, according to findings of one study.
“Prenatal stress appears to affect immune responses to both innate and adaptive stimuli at the time of birth—effects that may result in enhanced susceptibility to asthma or other atopic disorders,” said Dr. Rosalind J. Wright of Harvard Medical School in Boston and her associates (Am. J. Respir. Crit. Care Med. 2010 March 1 [doi:10.1164/rccm.200904-0637OC
The findings on seemingly stress-induced perinatal immune modulation may offer some new insight into the disproportionately high prevalence of asthma among ethnic minorities and disadvantaged urban communities.
In a prospective birth cohort study of urban, largely minority women, the investigators collected cord blood at birth and examined cord blood mononuclear cell (CBMC) cytokine responses to various innate and adaptive stimuli. Cytokine responses to both types of stimuli were significantly different in babies born to mothers with high levels of reported cumulative stress, compared with babies born to lower-stressed mothers.
In each case, the infants were at high risk for atopic diseases based on family history; either the mother or father had a history of asthma or allergy. Higher prenatal stress was related to increased production of interleukin-8 (IL-8) and tumor necrosis factor–alpha, for example, following microbial (CpG, PIC) stimuli.
For adaptive response, there was evidence that higher stress is tied to lower levels of interferon-gamma production in response to stimulation with PHA (a nonspecific mitogen), which has been linked to an increased risk for later atopic disease. Higher stress was also linked with an increased IL-13 response to dust mite antigen, which has been associated with allergic sensitization in older children.
The investigators studied 560 newborns and their mothers who live in Baltimore, Boston, New York, and St. Louis, and who were participating in the Urban Environment and Childhood Asthma Study. The mothers were primarily minorities (71% black and 19% Hispanic); 69% reported an annual income of less than $15,000.
Families answered detailed questions about various stressors in their lives, including financial hardship, community violence, and neighborhood and housing conditions.
The cohort will continue to be followed, enabling further assessment of the effects of prenatal and postnatal stress on infant immune development, and clinical outcomes, as the infants grow.
Disclosures: The study received funding from the National Institutes of Health. Dr. Wright also received funding from an NIH grant.
Prenatal stress is associated with altered patterns of cord blood cytokine production that may raise a child's asthma risk later in life, according to findings of one study.
“Prenatal stress appears to affect immune responses to both innate and adaptive stimuli at the time of birth—effects that may result in enhanced susceptibility to asthma or other atopic disorders,” said Dr. Rosalind J. Wright of Harvard Medical School in Boston and her associates (Am. J. Respir. Crit. Care Med. 2010 March 1 [doi:10.1164/rccm.200904-0637OC
The findings on seemingly stress-induced perinatal immune modulation may offer some new insight into the disproportionately high prevalence of asthma among ethnic minorities and disadvantaged urban communities.
In a prospective birth cohort study of urban, largely minority women, the investigators collected cord blood at birth and examined cord blood mononuclear cell (CBMC) cytokine responses to various innate and adaptive stimuli. Cytokine responses to both types of stimuli were significantly different in babies born to mothers with high levels of reported cumulative stress, compared with babies born to lower-stressed mothers.
In each case, the infants were at high risk for atopic diseases based on family history; either the mother or father had a history of asthma or allergy. Higher prenatal stress was related to increased production of interleukin-8 (IL-8) and tumor necrosis factor–alpha, for example, following microbial (CpG, PIC) stimuli.
For adaptive response, there was evidence that higher stress is tied to lower levels of interferon-gamma production in response to stimulation with PHA (a nonspecific mitogen), which has been linked to an increased risk for later atopic disease. Higher stress was also linked with an increased IL-13 response to dust mite antigen, which has been associated with allergic sensitization in older children.
The investigators studied 560 newborns and their mothers who live in Baltimore, Boston, New York, and St. Louis, and who were participating in the Urban Environment and Childhood Asthma Study. The mothers were primarily minorities (71% black and 19% Hispanic); 69% reported an annual income of less than $15,000.
Families answered detailed questions about various stressors in their lives, including financial hardship, community violence, and neighborhood and housing conditions.
The cohort will continue to be followed, enabling further assessment of the effects of prenatal and postnatal stress on infant immune development, and clinical outcomes, as the infants grow.
Disclosures: The study received funding from the National Institutes of Health. Dr. Wright also received funding from an NIH grant.
Ovarian Tissue Transplants Look Promising
Recently published reports from both sides of the Atlantic on ovarian tissue transplants suggest that the grafts have reasonable longevity and offer support for the development of cryopreservation and transplantation as a method of fertility preservation, U.S. experts told this news organization.
In a report from Denmark published online in Human Reproduction, investigators described the case of a woman who gave birth to her second child almost 3 years after six strips of frozen and thawed ovarian tissue were transplanted back to her ovary (2010 Feb. 25 [doi:10.1093/humrep/deq033]).
The woman became pregnant with her first child after mild ovarian stimulation soon after the transplant, but conceived naturally for her second pregnancy.
Another report published online in the American Society for Reproductive Medicine's journal Fertility and Sterility describes pregnancies and healthy babies in two groups of patients: a series of women who had premature ovarian failure and received a fresh donated ovary from a monozygotic twin and several women who had cryopreserved tissue transplanted (2010 Feb. 19 [doi:10.1016/j. fertnstert.2009.12.073]).
“What all this research suggests is that we're developing a body of evidence that indicates that it's possible to freeze and thaw ovarian strips and transplant them back,” resulting in successful pregnancies, said Dr. William Gibbons, ASRM president and professor and division director for reproductive endocrinology and infertility at Baylor College of Medicine in Houston. “Definitely, researchers have demonstrated proof of concept,” he said.
Comparing outcomes after fresh and frozen transplantation, as was done in the Fertility and Sterility report, is important for understanding the extent to which follicles are lost from cryopreservation, compared with ischemia, he noted.
Among the nine women described in the report who had transplantations of fresh ovarian tissue from their monozygotic twins, 12 pregnancies have occurred without assisted reproductive technology (ART) and eight healthy babies have been born to six of these women thus far, reported Dr. Sherman Silber of the Infertility Center of St. Louis and his associates.
Each of the women returned to regular menses and ovulatory cycles 60-130 days after one-quarter to one-third of the donor ovary was transplanted as a cortical slice, and conception often occurred within the first year after surgery. One woman conceived after 3 years however, and another had her second child more than 4 years ofter her transplant, they reported.
One of the women who had given birth to a healthy child after the transplant of fresh ovarian tissue became menopausal after about 3 years and had a second transplant of some of her twin's tissue that had been frozen. She became pregnant and gave birth to another healthy child. The patient again became menopausal another year-and-a-half later, had a second frozen graft, and was carrying her third child at the time of publication.
Another patient described in the report had a healthy ongoing pregnancy following a frozen transplant of tissue that she had cryopreserved 11 years earlier before treatment for Hodgkin's lymphoma.
Overall, the experience of these patients shows that pregnancy results after frozen transplantation are “as robust” as after fresh transplantation, although the duration of function may be shorter, Dr. Silber said in an interview.
“We used to think that freezing doesn't do any damage, and that the only damage is from ischemia,” he commented. “Now, our thinking has flipped…. Lengthy ischemia does not appear to be a major issue.”
Research has shown, meanwhile, that with standard “slow freezing” cryopreservation techniques, ovarian tissue loses about 50%-60% of its eggs. Dr. Silber said he is finding that vitrification—a “fast-freeze” process, in essence—may be more effective, resulting in percentages of viable oocytes that are “remarkably similar” to those found in fresh tissue grafts.
Reports of ovarian tissue transplants in cancer patients have generated questions about whether pregnancies are indeed achieved from eggs in the transplanted strips rather than eggs in the original ovary.
Dr. Silber said that, in the cases he and his associates looked at, they found no follicles during “intensive examinations” of patients' existing ovaries.
And in the European paper, Dr. Erik Ernst of Aarhus (Denmark) University Hospital and his colleagues reported that a biopsy obtained from the ovary in situ of their patient “revealed no remaining follicles upon histological examination.”
The patient treated in Denmark had previously had her left ovary removed because of a dermoid cyst involving the whole ovary. Approximately one-third of the right ovary (13 strips) was removed prior to chemotherapy for Ewing's sarcoma.
Among Dr. Silber's patients, there have been few miscarriages to date and no birth defects or obstetric complications associated with transplantation.
Questions remain, however, about “what can be done with frozen ovarian tissue of the leukemia survivor if there happen to have been leukemic cells in that tissue,” he and his associates wrote in their report.
“But for patients in whom there is no significant risk of ovarian metastasis, ovary tissue transplantation may now be ready for clinical use,” they said, noting that at least 1 in 250 women of reproductive age is a cancer survivor.
Disclosures: None was reported.
Recently published reports from both sides of the Atlantic on ovarian tissue transplants suggest that the grafts have reasonable longevity and offer support for the development of cryopreservation and transplantation as a method of fertility preservation, U.S. experts told this news organization.
In a report from Denmark published online in Human Reproduction, investigators described the case of a woman who gave birth to her second child almost 3 years after six strips of frozen and thawed ovarian tissue were transplanted back to her ovary (2010 Feb. 25 [doi:10.1093/humrep/deq033]).
The woman became pregnant with her first child after mild ovarian stimulation soon after the transplant, but conceived naturally for her second pregnancy.
Another report published online in the American Society for Reproductive Medicine's journal Fertility and Sterility describes pregnancies and healthy babies in two groups of patients: a series of women who had premature ovarian failure and received a fresh donated ovary from a monozygotic twin and several women who had cryopreserved tissue transplanted (2010 Feb. 19 [doi:10.1016/j. fertnstert.2009.12.073]).
“What all this research suggests is that we're developing a body of evidence that indicates that it's possible to freeze and thaw ovarian strips and transplant them back,” resulting in successful pregnancies, said Dr. William Gibbons, ASRM president and professor and division director for reproductive endocrinology and infertility at Baylor College of Medicine in Houston. “Definitely, researchers have demonstrated proof of concept,” he said.
Comparing outcomes after fresh and frozen transplantation, as was done in the Fertility and Sterility report, is important for understanding the extent to which follicles are lost from cryopreservation, compared with ischemia, he noted.
Among the nine women described in the report who had transplantations of fresh ovarian tissue from their monozygotic twins, 12 pregnancies have occurred without assisted reproductive technology (ART) and eight healthy babies have been born to six of these women thus far, reported Dr. Sherman Silber of the Infertility Center of St. Louis and his associates.
Each of the women returned to regular menses and ovulatory cycles 60-130 days after one-quarter to one-third of the donor ovary was transplanted as a cortical slice, and conception often occurred within the first year after surgery. One woman conceived after 3 years however, and another had her second child more than 4 years ofter her transplant, they reported.
One of the women who had given birth to a healthy child after the transplant of fresh ovarian tissue became menopausal after about 3 years and had a second transplant of some of her twin's tissue that had been frozen. She became pregnant and gave birth to another healthy child. The patient again became menopausal another year-and-a-half later, had a second frozen graft, and was carrying her third child at the time of publication.
Another patient described in the report had a healthy ongoing pregnancy following a frozen transplant of tissue that she had cryopreserved 11 years earlier before treatment for Hodgkin's lymphoma.
Overall, the experience of these patients shows that pregnancy results after frozen transplantation are “as robust” as after fresh transplantation, although the duration of function may be shorter, Dr. Silber said in an interview.
“We used to think that freezing doesn't do any damage, and that the only damage is from ischemia,” he commented. “Now, our thinking has flipped…. Lengthy ischemia does not appear to be a major issue.”
Research has shown, meanwhile, that with standard “slow freezing” cryopreservation techniques, ovarian tissue loses about 50%-60% of its eggs. Dr. Silber said he is finding that vitrification—a “fast-freeze” process, in essence—may be more effective, resulting in percentages of viable oocytes that are “remarkably similar” to those found in fresh tissue grafts.
Reports of ovarian tissue transplants in cancer patients have generated questions about whether pregnancies are indeed achieved from eggs in the transplanted strips rather than eggs in the original ovary.
Dr. Silber said that, in the cases he and his associates looked at, they found no follicles during “intensive examinations” of patients' existing ovaries.
And in the European paper, Dr. Erik Ernst of Aarhus (Denmark) University Hospital and his colleagues reported that a biopsy obtained from the ovary in situ of their patient “revealed no remaining follicles upon histological examination.”
The patient treated in Denmark had previously had her left ovary removed because of a dermoid cyst involving the whole ovary. Approximately one-third of the right ovary (13 strips) was removed prior to chemotherapy for Ewing's sarcoma.
Among Dr. Silber's patients, there have been few miscarriages to date and no birth defects or obstetric complications associated with transplantation.
Questions remain, however, about “what can be done with frozen ovarian tissue of the leukemia survivor if there happen to have been leukemic cells in that tissue,” he and his associates wrote in their report.
“But for patients in whom there is no significant risk of ovarian metastasis, ovary tissue transplantation may now be ready for clinical use,” they said, noting that at least 1 in 250 women of reproductive age is a cancer survivor.
Disclosures: None was reported.
Recently published reports from both sides of the Atlantic on ovarian tissue transplants suggest that the grafts have reasonable longevity and offer support for the development of cryopreservation and transplantation as a method of fertility preservation, U.S. experts told this news organization.
In a report from Denmark published online in Human Reproduction, investigators described the case of a woman who gave birth to her second child almost 3 years after six strips of frozen and thawed ovarian tissue were transplanted back to her ovary (2010 Feb. 25 [doi:10.1093/humrep/deq033]).
The woman became pregnant with her first child after mild ovarian stimulation soon after the transplant, but conceived naturally for her second pregnancy.
Another report published online in the American Society for Reproductive Medicine's journal Fertility and Sterility describes pregnancies and healthy babies in two groups of patients: a series of women who had premature ovarian failure and received a fresh donated ovary from a monozygotic twin and several women who had cryopreserved tissue transplanted (2010 Feb. 19 [doi:10.1016/j. fertnstert.2009.12.073]).
“What all this research suggests is that we're developing a body of evidence that indicates that it's possible to freeze and thaw ovarian strips and transplant them back,” resulting in successful pregnancies, said Dr. William Gibbons, ASRM president and professor and division director for reproductive endocrinology and infertility at Baylor College of Medicine in Houston. “Definitely, researchers have demonstrated proof of concept,” he said.
Comparing outcomes after fresh and frozen transplantation, as was done in the Fertility and Sterility report, is important for understanding the extent to which follicles are lost from cryopreservation, compared with ischemia, he noted.
Among the nine women described in the report who had transplantations of fresh ovarian tissue from their monozygotic twins, 12 pregnancies have occurred without assisted reproductive technology (ART) and eight healthy babies have been born to six of these women thus far, reported Dr. Sherman Silber of the Infertility Center of St. Louis and his associates.
Each of the women returned to regular menses and ovulatory cycles 60-130 days after one-quarter to one-third of the donor ovary was transplanted as a cortical slice, and conception often occurred within the first year after surgery. One woman conceived after 3 years however, and another had her second child more than 4 years ofter her transplant, they reported.
One of the women who had given birth to a healthy child after the transplant of fresh ovarian tissue became menopausal after about 3 years and had a second transplant of some of her twin's tissue that had been frozen. She became pregnant and gave birth to another healthy child. The patient again became menopausal another year-and-a-half later, had a second frozen graft, and was carrying her third child at the time of publication.
Another patient described in the report had a healthy ongoing pregnancy following a frozen transplant of tissue that she had cryopreserved 11 years earlier before treatment for Hodgkin's lymphoma.
Overall, the experience of these patients shows that pregnancy results after frozen transplantation are “as robust” as after fresh transplantation, although the duration of function may be shorter, Dr. Silber said in an interview.
“We used to think that freezing doesn't do any damage, and that the only damage is from ischemia,” he commented. “Now, our thinking has flipped…. Lengthy ischemia does not appear to be a major issue.”
Research has shown, meanwhile, that with standard “slow freezing” cryopreservation techniques, ovarian tissue loses about 50%-60% of its eggs. Dr. Silber said he is finding that vitrification—a “fast-freeze” process, in essence—may be more effective, resulting in percentages of viable oocytes that are “remarkably similar” to those found in fresh tissue grafts.
Reports of ovarian tissue transplants in cancer patients have generated questions about whether pregnancies are indeed achieved from eggs in the transplanted strips rather than eggs in the original ovary.
Dr. Silber said that, in the cases he and his associates looked at, they found no follicles during “intensive examinations” of patients' existing ovaries.
And in the European paper, Dr. Erik Ernst of Aarhus (Denmark) University Hospital and his colleagues reported that a biopsy obtained from the ovary in situ of their patient “revealed no remaining follicles upon histological examination.”
The patient treated in Denmark had previously had her left ovary removed because of a dermoid cyst involving the whole ovary. Approximately one-third of the right ovary (13 strips) was removed prior to chemotherapy for Ewing's sarcoma.
Among Dr. Silber's patients, there have been few miscarriages to date and no birth defects or obstetric complications associated with transplantation.
Questions remain, however, about “what can be done with frozen ovarian tissue of the leukemia survivor if there happen to have been leukemic cells in that tissue,” he and his associates wrote in their report.
“But for patients in whom there is no significant risk of ovarian metastasis, ovary tissue transplantation may now be ready for clinical use,” they said, noting that at least 1 in 250 women of reproductive age is a cancer survivor.
Disclosures: None was reported.
Physicians Neglecting Hypertension Guidelines : An IOM report suggests hypertension 'has dropped off the radar screen. It's time to bring it back on.'
WASHINGTON — Poor physician adherence to hypertension treatment guidelines is a significant reason why hypertension is undiagnosed and uncontrolled at “alarming rates” in the United States, according to an Institute of Medicine report.
Multiple studies have shown that physicians are not providing treatment consistent with the current Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. In particular, physicians are less aggressive about treating older patients, who are most likely to have the condition and who do benefit from therapy. They also are less aggressive in treating isolated systolic hypertension, according to the report.
“We really didn't find any information about why clinicians are not adhering to the most recent guidelines,” commented Dr. Corinne Husten, a member of the Committee on Public Health Priorities to Reduce and Control Hypertension in the U.S. Population, which wrote the report.
“It was quite striking, actually, that physicians do a pretty good job at controlling diastolic blood pressure…. It's systolic blood pressure that they're not aggressively treating, and especially isolated systolic hypertension,” she said at a briefing announcing their findings.
In the report, which was sponsored by the Centers for Disease Control and Prevention, the authors urge the CDC to give high priority to research on guideline adherence, and then to work with accreditation programs, providers, and health care quality organizations to improve providers' adherence to such recommendations.
The IOM committee urged the CDC to move away from a focus on individual and health care–based approaches in favor of taking population- and systems-based approaches that encourage people to lower their sodium intake, increase consumption of potassium, lose weight, and increase physical activity.
The CDC must ensure, they continued, that such population-based efforts—from those involving industry to various state and local projects—are properly targeting those at greatest risk. It also must work with health insurance plans and the Medicare and Medicaid programs to find ways to eliminate or reduce deductibles and co-pays for antihypertensive medications.
“This is where, in a time of limited resources, there's the greatest bang for the buck,” said Dr. David W. Fleming, who chaired the committee.
About three-quarters of Americans already recognize the importance of having their blood pressure checked, leading Dr. Fleming to emphasize that “we're not simply calling for better health education of the public.”
For example, the committee suggested that the CDC consider advocating for “greater use of potassium/sodium chloride combinations.”
In a recent report from the CDC, only about 2% of adults met the current guidelines for dietary potassium intake. Furthermore, more than 8 in 10 Americans consume more salt than is recommended, said Dr. Fleming, director of the department of public health in Seattle and a former deputy director of the CDC.
One in three Americans have hypertension, according to the IOM report, which calls hypertension a “neglected disease.” The disorder accounts for about one in six adult deaths annually, triggering more than one-third of heart attacks and almost half of heart failures.
Hypertension “has dropped off the radar screen,” Dr. Fleming said at the briefing. “It's time to bring it back on.”
Data show that 85% of individuals with uncontrolled hypertension have insurance and visit their physicians, the report noted.
Physicians may not adhere to current recommendations due to a lack of awareness about them or because they don't realize guidelines have been updated. Some physicians may still be waiting for patients to reach the previous 160 mm Hg/95 mm Hg thresholds before treating systolic and diastolic blood pressure, respectively. Current guidelines recommend starting treatment if systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure is greater than 90 mm Hg. Physician may also doubt the benefit of treatment, or may have concerns about drug side effects.
Dr. Husten was executive vice president for program and policy at the Partnership for Prevention in Washington during her work with the committee and has recently been appointed senior medical adviser to the Center for Tobacco Products at the Food and Drug Administration.
Disclosures: All committee members were screened and do not have any conflicts of interest, according to an IOM spokesperson.
WASHINGTON — Poor physician adherence to hypertension treatment guidelines is a significant reason why hypertension is undiagnosed and uncontrolled at “alarming rates” in the United States, according to an Institute of Medicine report.
Multiple studies have shown that physicians are not providing treatment consistent with the current Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. In particular, physicians are less aggressive about treating older patients, who are most likely to have the condition and who do benefit from therapy. They also are less aggressive in treating isolated systolic hypertension, according to the report.
“We really didn't find any information about why clinicians are not adhering to the most recent guidelines,” commented Dr. Corinne Husten, a member of the Committee on Public Health Priorities to Reduce and Control Hypertension in the U.S. Population, which wrote the report.
“It was quite striking, actually, that physicians do a pretty good job at controlling diastolic blood pressure…. It's systolic blood pressure that they're not aggressively treating, and especially isolated systolic hypertension,” she said at a briefing announcing their findings.
In the report, which was sponsored by the Centers for Disease Control and Prevention, the authors urge the CDC to give high priority to research on guideline adherence, and then to work with accreditation programs, providers, and health care quality organizations to improve providers' adherence to such recommendations.
The IOM committee urged the CDC to move away from a focus on individual and health care–based approaches in favor of taking population- and systems-based approaches that encourage people to lower their sodium intake, increase consumption of potassium, lose weight, and increase physical activity.
The CDC must ensure, they continued, that such population-based efforts—from those involving industry to various state and local projects—are properly targeting those at greatest risk. It also must work with health insurance plans and the Medicare and Medicaid programs to find ways to eliminate or reduce deductibles and co-pays for antihypertensive medications.
“This is where, in a time of limited resources, there's the greatest bang for the buck,” said Dr. David W. Fleming, who chaired the committee.
About three-quarters of Americans already recognize the importance of having their blood pressure checked, leading Dr. Fleming to emphasize that “we're not simply calling for better health education of the public.”
For example, the committee suggested that the CDC consider advocating for “greater use of potassium/sodium chloride combinations.”
In a recent report from the CDC, only about 2% of adults met the current guidelines for dietary potassium intake. Furthermore, more than 8 in 10 Americans consume more salt than is recommended, said Dr. Fleming, director of the department of public health in Seattle and a former deputy director of the CDC.
One in three Americans have hypertension, according to the IOM report, which calls hypertension a “neglected disease.” The disorder accounts for about one in six adult deaths annually, triggering more than one-third of heart attacks and almost half of heart failures.
Hypertension “has dropped off the radar screen,” Dr. Fleming said at the briefing. “It's time to bring it back on.”
Data show that 85% of individuals with uncontrolled hypertension have insurance and visit their physicians, the report noted.
Physicians may not adhere to current recommendations due to a lack of awareness about them or because they don't realize guidelines have been updated. Some physicians may still be waiting for patients to reach the previous 160 mm Hg/95 mm Hg thresholds before treating systolic and diastolic blood pressure, respectively. Current guidelines recommend starting treatment if systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure is greater than 90 mm Hg. Physician may also doubt the benefit of treatment, or may have concerns about drug side effects.
Dr. Husten was executive vice president for program and policy at the Partnership for Prevention in Washington during her work with the committee and has recently been appointed senior medical adviser to the Center for Tobacco Products at the Food and Drug Administration.
Disclosures: All committee members were screened and do not have any conflicts of interest, according to an IOM spokesperson.
WASHINGTON — Poor physician adherence to hypertension treatment guidelines is a significant reason why hypertension is undiagnosed and uncontrolled at “alarming rates” in the United States, according to an Institute of Medicine report.
Multiple studies have shown that physicians are not providing treatment consistent with the current Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. In particular, physicians are less aggressive about treating older patients, who are most likely to have the condition and who do benefit from therapy. They also are less aggressive in treating isolated systolic hypertension, according to the report.
“We really didn't find any information about why clinicians are not adhering to the most recent guidelines,” commented Dr. Corinne Husten, a member of the Committee on Public Health Priorities to Reduce and Control Hypertension in the U.S. Population, which wrote the report.
“It was quite striking, actually, that physicians do a pretty good job at controlling diastolic blood pressure…. It's systolic blood pressure that they're not aggressively treating, and especially isolated systolic hypertension,” she said at a briefing announcing their findings.
In the report, which was sponsored by the Centers for Disease Control and Prevention, the authors urge the CDC to give high priority to research on guideline adherence, and then to work with accreditation programs, providers, and health care quality organizations to improve providers' adherence to such recommendations.
The IOM committee urged the CDC to move away from a focus on individual and health care–based approaches in favor of taking population- and systems-based approaches that encourage people to lower their sodium intake, increase consumption of potassium, lose weight, and increase physical activity.
The CDC must ensure, they continued, that such population-based efforts—from those involving industry to various state and local projects—are properly targeting those at greatest risk. It also must work with health insurance plans and the Medicare and Medicaid programs to find ways to eliminate or reduce deductibles and co-pays for antihypertensive medications.
“This is where, in a time of limited resources, there's the greatest bang for the buck,” said Dr. David W. Fleming, who chaired the committee.
About three-quarters of Americans already recognize the importance of having their blood pressure checked, leading Dr. Fleming to emphasize that “we're not simply calling for better health education of the public.”
For example, the committee suggested that the CDC consider advocating for “greater use of potassium/sodium chloride combinations.”
In a recent report from the CDC, only about 2% of adults met the current guidelines for dietary potassium intake. Furthermore, more than 8 in 10 Americans consume more salt than is recommended, said Dr. Fleming, director of the department of public health in Seattle and a former deputy director of the CDC.
One in three Americans have hypertension, according to the IOM report, which calls hypertension a “neglected disease.” The disorder accounts for about one in six adult deaths annually, triggering more than one-third of heart attacks and almost half of heart failures.
Hypertension “has dropped off the radar screen,” Dr. Fleming said at the briefing. “It's time to bring it back on.”
Data show that 85% of individuals with uncontrolled hypertension have insurance and visit their physicians, the report noted.
Physicians may not adhere to current recommendations due to a lack of awareness about them or because they don't realize guidelines have been updated. Some physicians may still be waiting for patients to reach the previous 160 mm Hg/95 mm Hg thresholds before treating systolic and diastolic blood pressure, respectively. Current guidelines recommend starting treatment if systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure is greater than 90 mm Hg. Physician may also doubt the benefit of treatment, or may have concerns about drug side effects.
Dr. Husten was executive vice president for program and policy at the Partnership for Prevention in Washington during her work with the committee and has recently been appointed senior medical adviser to the Center for Tobacco Products at the Food and Drug Administration.
Disclosures: All committee members were screened and do not have any conflicts of interest, according to an IOM spokesperson.
Use of EMRs Urged to Implement Advanced Medical Home
Major Findings: Electronic medical records are essential to make pediatric medical homes a success, but systems for pediatricians fall short.
Source of Data: Expert commentary.
Disclosures: Dr. Johnson reported that he receives royalties from ICA Corp.
WASHINGTON — Pediatricians cannot truly provide an advanced medical home for their patients until they implement fully functional electronic medical record systems.
Although the current systems must still be improved to meet the needs of pediatricians, research is steadily accumulating that demonstrates the benefits of EMR systems for the specialty, Dr. Kevin B. Johnson said at the annual meeting of the American Academy of Pediatrics.
Papers published in the pediatric literature have shown, for instance, that integrated guidelines resulted in better guideline compliance, that physician-patient communication during visits was positively—not negatively—affected by computer-based documentation, and that electronic immunization tracking helps with case finding and improves coverage.
And for meeting the objectives of the medical home, EMR systems just make sense. “The most recent [national] conversation about the advanced medical home definitely thinks about the EMR as a key component of the infrastructure we need,” said Dr. Johnson, a pediatrician who is vice chair of the biomedical informatics department at Vanderbilt University Medical Center in Nashville.
The advanced medical home requires the use of EMRs that store and offer immediate access to all clinical data and test results, for instance, and that provide clinical decision-making support and links to other consultants and health care professionals.
EMRs also should provide the communication and scheduling systems that are needed for ongoing access to care and nonurgent advice, as well as open access scheduling (well-child care appointments in 1–2 days versus weeks, and more than 50% of appointments open each day).
“There is a lot of communication required in the medical home,” he said.
Communication is one area where currently available EMR systems fall short, however, and it's an area that pediatricians must speak up about, Dr. Johnson said. “Most systems don't [meet all our needs] because frankly [the vendors] don't understand what we want.”
When Dr. Johnson queried the AAP's “EMR review” Web site for perspective submitted over the past 2 years, he found other areas for improvement.
Sixteen percent of the 32 pediatricians who submitted information relevant to his query were not happy, for instance, with the immunization data handling/analysis capabilities on their systems. The same number—16%—said that growth parameters were not satisfactory, and 28% were not satisfied with their system's developmental milestone decision support.
“Your job,” he told the pediatricians, “is to help the systems get better.”
Dr. Johnson encouraged pediatricians to post reviews to the AAP's EMR Review Project Web site, which can be found at www.aapcocit.org/emr
National data indicate that about 15% of all practices have a basic EMR system (with patient demographics, problem lists, prescription orders, medication lists, clinical notes, and the ability to view lab results and images), whereas only 6% have a “fully functional” EMR system that allows them to send lab and radiology orders, for instance, and has evidence-based decision-making support.
“From what we know about pediatric primary care, the numbers are about the same,” Dr. Johnson said.
Pediatricians often tell him that they have a computer-based documentation tool but are hesitant to use it during visits because they “fear that it impacts patient-provider communication,” he noted.
In a study published last year, however, Dr. Johnson and his associates at Vanderbilt analyzed pediatric visits that were audiotaped or videotaped and found that any differences in communication dynamics between visits involving paper documentation and visits involving computer-based documentation “were in favor of computer-based documentation.”
The amount of conversation was slightly higher for visits involving computer-based documentation, for instance, as were the number of open-ended questions and “rapport-building statements” (Pediatrics 2008;122;590–8).
Numerous other studies have suggested that the use of computers in the exam room is not associated with worsening satisfaction, and his experience at Vanderbilt suggests that “parents love the technology,” said Dr. Johnson.
The advanced medical home requires the use of EMRs that store and offer access to all clinical data.
Source DR. JOHNSON
Major Findings: Electronic medical records are essential to make pediatric medical homes a success, but systems for pediatricians fall short.
Source of Data: Expert commentary.
Disclosures: Dr. Johnson reported that he receives royalties from ICA Corp.
WASHINGTON — Pediatricians cannot truly provide an advanced medical home for their patients until they implement fully functional electronic medical record systems.
Although the current systems must still be improved to meet the needs of pediatricians, research is steadily accumulating that demonstrates the benefits of EMR systems for the specialty, Dr. Kevin B. Johnson said at the annual meeting of the American Academy of Pediatrics.
Papers published in the pediatric literature have shown, for instance, that integrated guidelines resulted in better guideline compliance, that physician-patient communication during visits was positively—not negatively—affected by computer-based documentation, and that electronic immunization tracking helps with case finding and improves coverage.
And for meeting the objectives of the medical home, EMR systems just make sense. “The most recent [national] conversation about the advanced medical home definitely thinks about the EMR as a key component of the infrastructure we need,” said Dr. Johnson, a pediatrician who is vice chair of the biomedical informatics department at Vanderbilt University Medical Center in Nashville.
The advanced medical home requires the use of EMRs that store and offer immediate access to all clinical data and test results, for instance, and that provide clinical decision-making support and links to other consultants and health care professionals.
EMRs also should provide the communication and scheduling systems that are needed for ongoing access to care and nonurgent advice, as well as open access scheduling (well-child care appointments in 1–2 days versus weeks, and more than 50% of appointments open each day).
“There is a lot of communication required in the medical home,” he said.
Communication is one area where currently available EMR systems fall short, however, and it's an area that pediatricians must speak up about, Dr. Johnson said. “Most systems don't [meet all our needs] because frankly [the vendors] don't understand what we want.”
When Dr. Johnson queried the AAP's “EMR review” Web site for perspective submitted over the past 2 years, he found other areas for improvement.
Sixteen percent of the 32 pediatricians who submitted information relevant to his query were not happy, for instance, with the immunization data handling/analysis capabilities on their systems. The same number—16%—said that growth parameters were not satisfactory, and 28% were not satisfied with their system's developmental milestone decision support.
“Your job,” he told the pediatricians, “is to help the systems get better.”
Dr. Johnson encouraged pediatricians to post reviews to the AAP's EMR Review Project Web site, which can be found at www.aapcocit.org/emr
National data indicate that about 15% of all practices have a basic EMR system (with patient demographics, problem lists, prescription orders, medication lists, clinical notes, and the ability to view lab results and images), whereas only 6% have a “fully functional” EMR system that allows them to send lab and radiology orders, for instance, and has evidence-based decision-making support.
“From what we know about pediatric primary care, the numbers are about the same,” Dr. Johnson said.
Pediatricians often tell him that they have a computer-based documentation tool but are hesitant to use it during visits because they “fear that it impacts patient-provider communication,” he noted.
In a study published last year, however, Dr. Johnson and his associates at Vanderbilt analyzed pediatric visits that were audiotaped or videotaped and found that any differences in communication dynamics between visits involving paper documentation and visits involving computer-based documentation “were in favor of computer-based documentation.”
The amount of conversation was slightly higher for visits involving computer-based documentation, for instance, as were the number of open-ended questions and “rapport-building statements” (Pediatrics 2008;122;590–8).
Numerous other studies have suggested that the use of computers in the exam room is not associated with worsening satisfaction, and his experience at Vanderbilt suggests that “parents love the technology,” said Dr. Johnson.
The advanced medical home requires the use of EMRs that store and offer access to all clinical data.
Source DR. JOHNSON
Major Findings: Electronic medical records are essential to make pediatric medical homes a success, but systems for pediatricians fall short.
Source of Data: Expert commentary.
Disclosures: Dr. Johnson reported that he receives royalties from ICA Corp.
WASHINGTON — Pediatricians cannot truly provide an advanced medical home for their patients until they implement fully functional electronic medical record systems.
Although the current systems must still be improved to meet the needs of pediatricians, research is steadily accumulating that demonstrates the benefits of EMR systems for the specialty, Dr. Kevin B. Johnson said at the annual meeting of the American Academy of Pediatrics.
Papers published in the pediatric literature have shown, for instance, that integrated guidelines resulted in better guideline compliance, that physician-patient communication during visits was positively—not negatively—affected by computer-based documentation, and that electronic immunization tracking helps with case finding and improves coverage.
And for meeting the objectives of the medical home, EMR systems just make sense. “The most recent [national] conversation about the advanced medical home definitely thinks about the EMR as a key component of the infrastructure we need,” said Dr. Johnson, a pediatrician who is vice chair of the biomedical informatics department at Vanderbilt University Medical Center in Nashville.
The advanced medical home requires the use of EMRs that store and offer immediate access to all clinical data and test results, for instance, and that provide clinical decision-making support and links to other consultants and health care professionals.
EMRs also should provide the communication and scheduling systems that are needed for ongoing access to care and nonurgent advice, as well as open access scheduling (well-child care appointments in 1–2 days versus weeks, and more than 50% of appointments open each day).
“There is a lot of communication required in the medical home,” he said.
Communication is one area where currently available EMR systems fall short, however, and it's an area that pediatricians must speak up about, Dr. Johnson said. “Most systems don't [meet all our needs] because frankly [the vendors] don't understand what we want.”
When Dr. Johnson queried the AAP's “EMR review” Web site for perspective submitted over the past 2 years, he found other areas for improvement.
Sixteen percent of the 32 pediatricians who submitted information relevant to his query were not happy, for instance, with the immunization data handling/analysis capabilities on their systems. The same number—16%—said that growth parameters were not satisfactory, and 28% were not satisfied with their system's developmental milestone decision support.
“Your job,” he told the pediatricians, “is to help the systems get better.”
Dr. Johnson encouraged pediatricians to post reviews to the AAP's EMR Review Project Web site, which can be found at www.aapcocit.org/emr
National data indicate that about 15% of all practices have a basic EMR system (with patient demographics, problem lists, prescription orders, medication lists, clinical notes, and the ability to view lab results and images), whereas only 6% have a “fully functional” EMR system that allows them to send lab and radiology orders, for instance, and has evidence-based decision-making support.
“From what we know about pediatric primary care, the numbers are about the same,” Dr. Johnson said.
Pediatricians often tell him that they have a computer-based documentation tool but are hesitant to use it during visits because they “fear that it impacts patient-provider communication,” he noted.
In a study published last year, however, Dr. Johnson and his associates at Vanderbilt analyzed pediatric visits that were audiotaped or videotaped and found that any differences in communication dynamics between visits involving paper documentation and visits involving computer-based documentation “were in favor of computer-based documentation.”
The amount of conversation was slightly higher for visits involving computer-based documentation, for instance, as were the number of open-ended questions and “rapport-building statements” (Pediatrics 2008;122;590–8).
Numerous other studies have suggested that the use of computers in the exam room is not associated with worsening satisfaction, and his experience at Vanderbilt suggests that “parents love the technology,” said Dr. Johnson.
The advanced medical home requires the use of EMRs that store and offer access to all clinical data.
Source DR. JOHNSON
EHR Funding May Be a Problem for Pediatricians
WASHINGTON — The attention and funding given to electronic health records under the Recovery Act means that “it's time for pediatricians to get involved,” said Janet Marchibroda, former chief executive officer of the eHealth Initiative.
Wider adoption of health IT “is definitely going to happen now—we're there,” Ms. Marchibroda told attendees at the annual meeting of the American Academy of Pediatrics.
Outside of the meeting halls, however, there was skepticism that enough pediatricians would be candidates for the financial incentives provided through the Recovery Act to make a significant difference.
In an interview, Dr. Joseph H. Schneider, chairperson of the AAP's Council on Clinical Information Technology (COCIT), said that requirements that practices demonstrate specific case mix thresholds in order to qualify for Medicaid EHR incentives mean that “for many pediatricians, this offer of money is really a hollow promise.”
The Recovery Act—formally known as the American Recovery and Reinvestment Act of 2009—set aside almost $45 billion of stimulus money to encourage the adoption of electronic health records through Medicare and Medicaid incentives that will be offered to providers who purchase a certified EHR system and make “meaningful use” of the technology, Ms. Marchibroda explained at the meeting.
Another $564 million will support statewide “Health Information Exchange (HIE) Cooperative Agreements” that will “help build HIE capacity,” she said, and $643 million will support approximately 70 health IT “regional extension centers” that will help health care providers select and implement E technology. States and nonprofit organizations applied for grants for these programs this fall; both efforts should be underway this month, she said.
“A lot will be happening in your communities,” said Ms. Marchibroda, now chief health care officer at IBM. “It's time to start a conversation with all the organizations with which you interact [from hospital systems to health plans and labs].”
Opportunities to purchase EHRs with Medicaid incentive money will come later, however—and only for those non–hospital-based pediatricians who have at least a 30% Medicaid patient volume or those who practice predominantly in federally qualified health centers or rural health clinics and have at least 30% of the patient volume attributable to “needy” patients.
Pediatricians with a 20% Medicaid volume will be eligible to receive two-thirds of the incentives, but even this lower threshold will exclude many pediatricians, said Dr. Schneider, who practices pediatrics in Dallas.
This means that pediatricians with at least 30% Medicaid volume could receive up to $63,750 over a 5-year period under the Recovery Act, he said. And those with at least 20% Medicaid volume could receive up to $42,500 over a 5-year period.
For those who do qualify, Ms. Marchibroda explained after the meeting, Medicaid will pay up to 85% of the costs related to EHR adoption and operations.
Another problem for pediatricians, Dr. Schneider said, lies with the “meaningful use” requirements. Such requirements will be defined nationally for incentives provided through the Medicare program, but for Medicaid-provided incentives, states have the ability under the Recovery Act to define their own meaningful use standards.
At least some states have been discussing the possibility of developing common definitions, and some have been waiting to see the draft Medicare regulations defining meaningful use that were expected from the Centers for Medicare and Medicaid Services last month. (A final rule will be issued in spring 2010.)
By tying funds to Medicaid, “Congress has left us with a tough ball to untangle,” he said. (Some types of measures of meaningful use, like the provision of personal health record information to patients and the ability to exchange information with other providers, are common to pediatric and adult care, but other measures—like quality measures—can be quite different, Dr. Schneider said.)
EHR vendors have catered more to the larger market of adult patient populations in designing their systems thus far, and “if states end up with varying meaningful use definitions and definitions that are significantly different from Medicare's, then the EHR vendors will probably ignore pediatric needs [even more],” Dr. Schneider said.
At various points in time, the AAP has urged Congress to include the Children's Health Insurance Program in the EHR incentive process, to repeal the ability of state Medicaid programs to modify the definition of meaningful use from a national standard, and to lower the threshold for Medicaid as far as possible in order to provide incentive payments to as many Medicaid providers as possible.
Now, Dr. Schneider said, the goals of the AAP's COCIT and its new Child Health Informatics Center include working with the states to minimize variation in definitions of meaningful use, and working with the new regional extension centers to “provide a common approach to helping pediatricians” select and implement EHRs that are friendly to their patient populations and their workflow. Surveys done in 2006 showed that one-third of office-based pediatric practices had no plans to implement an EHR system; 70% of these were solo practitioners.
Will the Recovery Act's incentives and technical assistance programs change their minds, or spur on those who are teetering? Ms. Marchibroda said she hopes so, though the goals, she admits, are high. “Congress's intention in the Recovery Act is to grow the numbers to 90% adoption by physicians and 70% by hospitals,” she said. “So we have a long way to go.”
The organization that Ms. Marchibroda led until earlier this year—the eHealth Initiative—is a multidisciplinary nonprofit organization whose members include employers and purchasers, accrediting groups, physician groups, and patient and consumer groups.
WASHINGTON — The attention and funding given to electronic health records under the Recovery Act means that “it's time for pediatricians to get involved,” said Janet Marchibroda, former chief executive officer of the eHealth Initiative.
Wider adoption of health IT “is definitely going to happen now—we're there,” Ms. Marchibroda told attendees at the annual meeting of the American Academy of Pediatrics.
Outside of the meeting halls, however, there was skepticism that enough pediatricians would be candidates for the financial incentives provided through the Recovery Act to make a significant difference.
In an interview, Dr. Joseph H. Schneider, chairperson of the AAP's Council on Clinical Information Technology (COCIT), said that requirements that practices demonstrate specific case mix thresholds in order to qualify for Medicaid EHR incentives mean that “for many pediatricians, this offer of money is really a hollow promise.”
The Recovery Act—formally known as the American Recovery and Reinvestment Act of 2009—set aside almost $45 billion of stimulus money to encourage the adoption of electronic health records through Medicare and Medicaid incentives that will be offered to providers who purchase a certified EHR system and make “meaningful use” of the technology, Ms. Marchibroda explained at the meeting.
Another $564 million will support statewide “Health Information Exchange (HIE) Cooperative Agreements” that will “help build HIE capacity,” she said, and $643 million will support approximately 70 health IT “regional extension centers” that will help health care providers select and implement E technology. States and nonprofit organizations applied for grants for these programs this fall; both efforts should be underway this month, she said.
“A lot will be happening in your communities,” said Ms. Marchibroda, now chief health care officer at IBM. “It's time to start a conversation with all the organizations with which you interact [from hospital systems to health plans and labs].”
Opportunities to purchase EHRs with Medicaid incentive money will come later, however—and only for those non–hospital-based pediatricians who have at least a 30% Medicaid patient volume or those who practice predominantly in federally qualified health centers or rural health clinics and have at least 30% of the patient volume attributable to “needy” patients.
Pediatricians with a 20% Medicaid volume will be eligible to receive two-thirds of the incentives, but even this lower threshold will exclude many pediatricians, said Dr. Schneider, who practices pediatrics in Dallas.
This means that pediatricians with at least 30% Medicaid volume could receive up to $63,750 over a 5-year period under the Recovery Act, he said. And those with at least 20% Medicaid volume could receive up to $42,500 over a 5-year period.
For those who do qualify, Ms. Marchibroda explained after the meeting, Medicaid will pay up to 85% of the costs related to EHR adoption and operations.
Another problem for pediatricians, Dr. Schneider said, lies with the “meaningful use” requirements. Such requirements will be defined nationally for incentives provided through the Medicare program, but for Medicaid-provided incentives, states have the ability under the Recovery Act to define their own meaningful use standards.
At least some states have been discussing the possibility of developing common definitions, and some have been waiting to see the draft Medicare regulations defining meaningful use that were expected from the Centers for Medicare and Medicaid Services last month. (A final rule will be issued in spring 2010.)
By tying funds to Medicaid, “Congress has left us with a tough ball to untangle,” he said. (Some types of measures of meaningful use, like the provision of personal health record information to patients and the ability to exchange information with other providers, are common to pediatric and adult care, but other measures—like quality measures—can be quite different, Dr. Schneider said.)
EHR vendors have catered more to the larger market of adult patient populations in designing their systems thus far, and “if states end up with varying meaningful use definitions and definitions that are significantly different from Medicare's, then the EHR vendors will probably ignore pediatric needs [even more],” Dr. Schneider said.
At various points in time, the AAP has urged Congress to include the Children's Health Insurance Program in the EHR incentive process, to repeal the ability of state Medicaid programs to modify the definition of meaningful use from a national standard, and to lower the threshold for Medicaid as far as possible in order to provide incentive payments to as many Medicaid providers as possible.
Now, Dr. Schneider said, the goals of the AAP's COCIT and its new Child Health Informatics Center include working with the states to minimize variation in definitions of meaningful use, and working with the new regional extension centers to “provide a common approach to helping pediatricians” select and implement EHRs that are friendly to their patient populations and their workflow. Surveys done in 2006 showed that one-third of office-based pediatric practices had no plans to implement an EHR system; 70% of these were solo practitioners.
Will the Recovery Act's incentives and technical assistance programs change their minds, or spur on those who are teetering? Ms. Marchibroda said she hopes so, though the goals, she admits, are high. “Congress's intention in the Recovery Act is to grow the numbers to 90% adoption by physicians and 70% by hospitals,” she said. “So we have a long way to go.”
The organization that Ms. Marchibroda led until earlier this year—the eHealth Initiative—is a multidisciplinary nonprofit organization whose members include employers and purchasers, accrediting groups, physician groups, and patient and consumer groups.
WASHINGTON — The attention and funding given to electronic health records under the Recovery Act means that “it's time for pediatricians to get involved,” said Janet Marchibroda, former chief executive officer of the eHealth Initiative.
Wider adoption of health IT “is definitely going to happen now—we're there,” Ms. Marchibroda told attendees at the annual meeting of the American Academy of Pediatrics.
Outside of the meeting halls, however, there was skepticism that enough pediatricians would be candidates for the financial incentives provided through the Recovery Act to make a significant difference.
In an interview, Dr. Joseph H. Schneider, chairperson of the AAP's Council on Clinical Information Technology (COCIT), said that requirements that practices demonstrate specific case mix thresholds in order to qualify for Medicaid EHR incentives mean that “for many pediatricians, this offer of money is really a hollow promise.”
The Recovery Act—formally known as the American Recovery and Reinvestment Act of 2009—set aside almost $45 billion of stimulus money to encourage the adoption of electronic health records through Medicare and Medicaid incentives that will be offered to providers who purchase a certified EHR system and make “meaningful use” of the technology, Ms. Marchibroda explained at the meeting.
Another $564 million will support statewide “Health Information Exchange (HIE) Cooperative Agreements” that will “help build HIE capacity,” she said, and $643 million will support approximately 70 health IT “regional extension centers” that will help health care providers select and implement E technology. States and nonprofit organizations applied for grants for these programs this fall; both efforts should be underway this month, she said.
“A lot will be happening in your communities,” said Ms. Marchibroda, now chief health care officer at IBM. “It's time to start a conversation with all the organizations with which you interact [from hospital systems to health plans and labs].”
Opportunities to purchase EHRs with Medicaid incentive money will come later, however—and only for those non–hospital-based pediatricians who have at least a 30% Medicaid patient volume or those who practice predominantly in federally qualified health centers or rural health clinics and have at least 30% of the patient volume attributable to “needy” patients.
Pediatricians with a 20% Medicaid volume will be eligible to receive two-thirds of the incentives, but even this lower threshold will exclude many pediatricians, said Dr. Schneider, who practices pediatrics in Dallas.
This means that pediatricians with at least 30% Medicaid volume could receive up to $63,750 over a 5-year period under the Recovery Act, he said. And those with at least 20% Medicaid volume could receive up to $42,500 over a 5-year period.
For those who do qualify, Ms. Marchibroda explained after the meeting, Medicaid will pay up to 85% of the costs related to EHR adoption and operations.
Another problem for pediatricians, Dr. Schneider said, lies with the “meaningful use” requirements. Such requirements will be defined nationally for incentives provided through the Medicare program, but for Medicaid-provided incentives, states have the ability under the Recovery Act to define their own meaningful use standards.
At least some states have been discussing the possibility of developing common definitions, and some have been waiting to see the draft Medicare regulations defining meaningful use that were expected from the Centers for Medicare and Medicaid Services last month. (A final rule will be issued in spring 2010.)
By tying funds to Medicaid, “Congress has left us with a tough ball to untangle,” he said. (Some types of measures of meaningful use, like the provision of personal health record information to patients and the ability to exchange information with other providers, are common to pediatric and adult care, but other measures—like quality measures—can be quite different, Dr. Schneider said.)
EHR vendors have catered more to the larger market of adult patient populations in designing their systems thus far, and “if states end up with varying meaningful use definitions and definitions that are significantly different from Medicare's, then the EHR vendors will probably ignore pediatric needs [even more],” Dr. Schneider said.
At various points in time, the AAP has urged Congress to include the Children's Health Insurance Program in the EHR incentive process, to repeal the ability of state Medicaid programs to modify the definition of meaningful use from a national standard, and to lower the threshold for Medicaid as far as possible in order to provide incentive payments to as many Medicaid providers as possible.
Now, Dr. Schneider said, the goals of the AAP's COCIT and its new Child Health Informatics Center include working with the states to minimize variation in definitions of meaningful use, and working with the new regional extension centers to “provide a common approach to helping pediatricians” select and implement EHRs that are friendly to their patient populations and their workflow. Surveys done in 2006 showed that one-third of office-based pediatric practices had no plans to implement an EHR system; 70% of these were solo practitioners.
Will the Recovery Act's incentives and technical assistance programs change their minds, or spur on those who are teetering? Ms. Marchibroda said she hopes so, though the goals, she admits, are high. “Congress's intention in the Recovery Act is to grow the numbers to 90% adoption by physicians and 70% by hospitals,” she said. “So we have a long way to go.”
The organization that Ms. Marchibroda led until earlier this year—the eHealth Initiative—is a multidisciplinary nonprofit organization whose members include employers and purchasers, accrediting groups, physician groups, and patient and consumer groups.
Adapalene Advised for Mild, Moderate Acne
WASHINGTON — The newer topical retinoid adapalene is often the best front-line agent for the management of mild to moderate acne because it can be applied along with benzoyl peroxide, according to Dr. Richard J. Antaya.
Adapalene (Differin) “is a much more stable molecule, so you can apply it with other medications like benzoyl peroxide,” said Dr. Antaya, director of pediatric dermatology at Yale University in New Haven, Conn. “Retin-A gets broken down much more easily.”
Although a topical retinoid alone is effective for mild acne that is primarily comedonal, benzoyl peroxide (a topical antibacterial) should be added when the acne has a papulopustular component, he explained at the annual meeting of the American Academy of Pediatrics.
A topical antibiotic also should be part of the regimen if the acne is more severe at presentation or if it does not improve in 6-12 weeks of treatment with a retinoid and benzoyl peroxide.
Moisturizers are a critical part of acne management since all medications cause some degree of erythema, drying, or peeling. “With Tazorac [tazarotene, another newer-generation topical retinoid], because it's so irritating, we've actually realized that if you put moisturizer on before the Tazorac, it actually slows the [drug's] absorption and softens the blow so you get less irritation,” he noted.
Dr. Antaya said that he has had no financial relationships in the past year with any manufacturers of these products.
WASHINGTON — The newer topical retinoid adapalene is often the best front-line agent for the management of mild to moderate acne because it can be applied along with benzoyl peroxide, according to Dr. Richard J. Antaya.
Adapalene (Differin) “is a much more stable molecule, so you can apply it with other medications like benzoyl peroxide,” said Dr. Antaya, director of pediatric dermatology at Yale University in New Haven, Conn. “Retin-A gets broken down much more easily.”
Although a topical retinoid alone is effective for mild acne that is primarily comedonal, benzoyl peroxide (a topical antibacterial) should be added when the acne has a papulopustular component, he explained at the annual meeting of the American Academy of Pediatrics.
A topical antibiotic also should be part of the regimen if the acne is more severe at presentation or if it does not improve in 6-12 weeks of treatment with a retinoid and benzoyl peroxide.
Moisturizers are a critical part of acne management since all medications cause some degree of erythema, drying, or peeling. “With Tazorac [tazarotene, another newer-generation topical retinoid], because it's so irritating, we've actually realized that if you put moisturizer on before the Tazorac, it actually slows the [drug's] absorption and softens the blow so you get less irritation,” he noted.
Dr. Antaya said that he has had no financial relationships in the past year with any manufacturers of these products.
WASHINGTON — The newer topical retinoid adapalene is often the best front-line agent for the management of mild to moderate acne because it can be applied along with benzoyl peroxide, according to Dr. Richard J. Antaya.
Adapalene (Differin) “is a much more stable molecule, so you can apply it with other medications like benzoyl peroxide,” said Dr. Antaya, director of pediatric dermatology at Yale University in New Haven, Conn. “Retin-A gets broken down much more easily.”
Although a topical retinoid alone is effective for mild acne that is primarily comedonal, benzoyl peroxide (a topical antibacterial) should be added when the acne has a papulopustular component, he explained at the annual meeting of the American Academy of Pediatrics.
A topical antibiotic also should be part of the regimen if the acne is more severe at presentation or if it does not improve in 6-12 weeks of treatment with a retinoid and benzoyl peroxide.
Moisturizers are a critical part of acne management since all medications cause some degree of erythema, drying, or peeling. “With Tazorac [tazarotene, another newer-generation topical retinoid], because it's so irritating, we've actually realized that if you put moisturizer on before the Tazorac, it actually slows the [drug's] absorption and softens the blow so you get less irritation,” he noted.
Dr. Antaya said that he has had no financial relationships in the past year with any manufacturers of these products.
Preparticipation Screening Not Just for Sports
WASHINGTON — Incorporating preparticipation screening into routine health supervision visits for all youth—not just those playing competitive sports—is one of the recommendations in an updated monograph being published by the American Academy of Pediatrics, Dr. David T. Bernhardt announced at the AAP's annual meeting.
The new recommendations, slated for released in the spring of 2010, also will weigh in on the use of ECGs and other tests to screen athletes for causes of sudden cardiac death, saying that such testing would be impractical, too costly, and challenged by false-positive test results, he said.
The new emphasis on wider, more routine use of the evaluation is in keeping with the growing emphasis on sports and other activities for good health, said Dr. Bernhardt, coeditor of the monograph, who is with the department of pediatrics and the division of sports medicine at the University of Wisconsin, Madison.
“Think about the kid playing a club sport, where there's no demand or regulation for a [signed preparticipation card], or kids skiing or playing at recess,” he said. “They may be playing tag or hula-hoop with just as much vigor as the older kids who are participating … for a scholarship.”
The overarching goal of the preparticipation evaluation, to promote the health and safety of athletes, “should be the same for every youngster coming into your clinic,” he emphasized.
Incorporating an additional set of questions into the well-child visit will require some thought, Dr. Bernhardt said in an interview. “If we want to be uniform in asking the right questions, we should use the [health] form in the visits … but realistically, this won't happen,” he said.
Asking families to complete the form before the visit, or incorporating at least parts of the form into the practice's overall history forms, could work, especially among practices using technology and electronic health records, he noted.
The issue of cardiovascular screening, and how best to prevent sudden cardiac death during intense physical activity, has become increasingly controversial since the last monograph on preparticipation screenings was published in 2004. The International Olympic Committee began endorsing ECGs for screening that year, and the European Society of Cardiology followed suit in 2005.
Although rare, sudden deaths of young competitive athletes have been reported more frequently in recent years and have been highly publicized. “More families have access to the Internet and read about [these tragedies] and what others are doing to screen” for sudden cardiac death, making it important for pediatricians and other physicians to be able to discuss the limitations of widespread screening with ECGs and other tests, Dr. Bernhardt said in the interview.
The European recommendations stem from a unique experience in Italy in which all athletes aged 12-35 years have been required for more than 25 years to obtain medical clearance—based on history, physical examination, and a 12-lead ECG—by certified physicians at designated screening centers. Italian investigators reported that the annual incidence of sudden cardiac death decreased by 89% in screened athletes in the Veneto region of Italy since the state-subsidized screening program was implemented (JAMA 2006;296:1593-601).
The screening program was predicated on an unusually high incidence of arrhythmogenic right ventricular dysplasia (ARVD) in the region, however, and the 89% drop reported in the JAMA study brings the rate of sudden cardiac death in the region “to about what we see in our country,” Dr. Bernhardt said at the AAP meeting.
An analysis of sudden deaths in U.S. athletes since 1980 showed that about 4% of the sudden cardiac deaths in athletes under 35 since 1980 have been caused by ARVD, he noted (Circulation 2009;119:1085-92). The most common cause, reportedly responsible for about 36% of the sudden cardiac deaths, was hypertrophic cardiomyopathy. (Cardiovascular sudden deaths occurred at a rate of less than 80/year, according to the study.)
The incidence of sudden cardiac death is about 1 in 75,000 competitive athletes, Dr. Bernhardt said, so “you're truly trying to find a needle in a haystack.”
Studies of ECG abnormalities in athletes have clearly shown that borderline or false-positive results are common. In one Italian study, investigators determined that the test's sensitivity was 51%, its specificity 61%, its positive predictive value 7%, and its negative predictive value 96%, he said.
The potential for false-positive results, combined with the size of the U.S. population, limited financial resources, and limited numbers of trained physicians, make the routine use of tests such as ECGs unwise in this country, Dr. Bernhardt added.
The AAP and its monograph cosponsors recommend a thorough personal and family history and physical exam as the best screening strategy. The monograph will incorporate the American Heart Association's recommendations for cardiovascular screening, along with questions about unexplained seizure and whether any family member or relative has died of sudden infant death syndrome, Dr. Bernhardt said.
The monograph will recommend that evaluations be performed in a primary care physician's office for better continuity of care, “rather than in station-based formats at schools or drugstores,” he said.
The new recommendations will also address legal concerns such as the ability of primary care or team physicians to rescind participation clearance based on changes in an athlete's health status, he said.
The AAP, along with the American Academy of Family Physicians and several sports medicine associations, has been a sponsoring organization of previous versions of the Preparticipation Physical Evaluation monograph. The new monograph will be sold, but the updated history and physical exam forms contained in the book will be available free of charge through sponsoring organizations.
WASHINGTON — Incorporating preparticipation screening into routine health supervision visits for all youth—not just those playing competitive sports—is one of the recommendations in an updated monograph being published by the American Academy of Pediatrics, Dr. David T. Bernhardt announced at the AAP's annual meeting.
The new recommendations, slated for released in the spring of 2010, also will weigh in on the use of ECGs and other tests to screen athletes for causes of sudden cardiac death, saying that such testing would be impractical, too costly, and challenged by false-positive test results, he said.
The new emphasis on wider, more routine use of the evaluation is in keeping with the growing emphasis on sports and other activities for good health, said Dr. Bernhardt, coeditor of the monograph, who is with the department of pediatrics and the division of sports medicine at the University of Wisconsin, Madison.
“Think about the kid playing a club sport, where there's no demand or regulation for a [signed preparticipation card], or kids skiing or playing at recess,” he said. “They may be playing tag or hula-hoop with just as much vigor as the older kids who are participating … for a scholarship.”
The overarching goal of the preparticipation evaluation, to promote the health and safety of athletes, “should be the same for every youngster coming into your clinic,” he emphasized.
Incorporating an additional set of questions into the well-child visit will require some thought, Dr. Bernhardt said in an interview. “If we want to be uniform in asking the right questions, we should use the [health] form in the visits … but realistically, this won't happen,” he said.
Asking families to complete the form before the visit, or incorporating at least parts of the form into the practice's overall history forms, could work, especially among practices using technology and electronic health records, he noted.
The issue of cardiovascular screening, and how best to prevent sudden cardiac death during intense physical activity, has become increasingly controversial since the last monograph on preparticipation screenings was published in 2004. The International Olympic Committee began endorsing ECGs for screening that year, and the European Society of Cardiology followed suit in 2005.
Although rare, sudden deaths of young competitive athletes have been reported more frequently in recent years and have been highly publicized. “More families have access to the Internet and read about [these tragedies] and what others are doing to screen” for sudden cardiac death, making it important for pediatricians and other physicians to be able to discuss the limitations of widespread screening with ECGs and other tests, Dr. Bernhardt said in the interview.
The European recommendations stem from a unique experience in Italy in which all athletes aged 12-35 years have been required for more than 25 years to obtain medical clearance—based on history, physical examination, and a 12-lead ECG—by certified physicians at designated screening centers. Italian investigators reported that the annual incidence of sudden cardiac death decreased by 89% in screened athletes in the Veneto region of Italy since the state-subsidized screening program was implemented (JAMA 2006;296:1593-601).
The screening program was predicated on an unusually high incidence of arrhythmogenic right ventricular dysplasia (ARVD) in the region, however, and the 89% drop reported in the JAMA study brings the rate of sudden cardiac death in the region “to about what we see in our country,” Dr. Bernhardt said at the AAP meeting.
An analysis of sudden deaths in U.S. athletes since 1980 showed that about 4% of the sudden cardiac deaths in athletes under 35 since 1980 have been caused by ARVD, he noted (Circulation 2009;119:1085-92). The most common cause, reportedly responsible for about 36% of the sudden cardiac deaths, was hypertrophic cardiomyopathy. (Cardiovascular sudden deaths occurred at a rate of less than 80/year, according to the study.)
The incidence of sudden cardiac death is about 1 in 75,000 competitive athletes, Dr. Bernhardt said, so “you're truly trying to find a needle in a haystack.”
Studies of ECG abnormalities in athletes have clearly shown that borderline or false-positive results are common. In one Italian study, investigators determined that the test's sensitivity was 51%, its specificity 61%, its positive predictive value 7%, and its negative predictive value 96%, he said.
The potential for false-positive results, combined with the size of the U.S. population, limited financial resources, and limited numbers of trained physicians, make the routine use of tests such as ECGs unwise in this country, Dr. Bernhardt added.
The AAP and its monograph cosponsors recommend a thorough personal and family history and physical exam as the best screening strategy. The monograph will incorporate the American Heart Association's recommendations for cardiovascular screening, along with questions about unexplained seizure and whether any family member or relative has died of sudden infant death syndrome, Dr. Bernhardt said.
The monograph will recommend that evaluations be performed in a primary care physician's office for better continuity of care, “rather than in station-based formats at schools or drugstores,” he said.
The new recommendations will also address legal concerns such as the ability of primary care or team physicians to rescind participation clearance based on changes in an athlete's health status, he said.
The AAP, along with the American Academy of Family Physicians and several sports medicine associations, has been a sponsoring organization of previous versions of the Preparticipation Physical Evaluation monograph. The new monograph will be sold, but the updated history and physical exam forms contained in the book will be available free of charge through sponsoring organizations.
WASHINGTON — Incorporating preparticipation screening into routine health supervision visits for all youth—not just those playing competitive sports—is one of the recommendations in an updated monograph being published by the American Academy of Pediatrics, Dr. David T. Bernhardt announced at the AAP's annual meeting.
The new recommendations, slated for released in the spring of 2010, also will weigh in on the use of ECGs and other tests to screen athletes for causes of sudden cardiac death, saying that such testing would be impractical, too costly, and challenged by false-positive test results, he said.
The new emphasis on wider, more routine use of the evaluation is in keeping with the growing emphasis on sports and other activities for good health, said Dr. Bernhardt, coeditor of the monograph, who is with the department of pediatrics and the division of sports medicine at the University of Wisconsin, Madison.
“Think about the kid playing a club sport, where there's no demand or regulation for a [signed preparticipation card], or kids skiing or playing at recess,” he said. “They may be playing tag or hula-hoop with just as much vigor as the older kids who are participating … for a scholarship.”
The overarching goal of the preparticipation evaluation, to promote the health and safety of athletes, “should be the same for every youngster coming into your clinic,” he emphasized.
Incorporating an additional set of questions into the well-child visit will require some thought, Dr. Bernhardt said in an interview. “If we want to be uniform in asking the right questions, we should use the [health] form in the visits … but realistically, this won't happen,” he said.
Asking families to complete the form before the visit, or incorporating at least parts of the form into the practice's overall history forms, could work, especially among practices using technology and electronic health records, he noted.
The issue of cardiovascular screening, and how best to prevent sudden cardiac death during intense physical activity, has become increasingly controversial since the last monograph on preparticipation screenings was published in 2004. The International Olympic Committee began endorsing ECGs for screening that year, and the European Society of Cardiology followed suit in 2005.
Although rare, sudden deaths of young competitive athletes have been reported more frequently in recent years and have been highly publicized. “More families have access to the Internet and read about [these tragedies] and what others are doing to screen” for sudden cardiac death, making it important for pediatricians and other physicians to be able to discuss the limitations of widespread screening with ECGs and other tests, Dr. Bernhardt said in the interview.
The European recommendations stem from a unique experience in Italy in which all athletes aged 12-35 years have been required for more than 25 years to obtain medical clearance—based on history, physical examination, and a 12-lead ECG—by certified physicians at designated screening centers. Italian investigators reported that the annual incidence of sudden cardiac death decreased by 89% in screened athletes in the Veneto region of Italy since the state-subsidized screening program was implemented (JAMA 2006;296:1593-601).
The screening program was predicated on an unusually high incidence of arrhythmogenic right ventricular dysplasia (ARVD) in the region, however, and the 89% drop reported in the JAMA study brings the rate of sudden cardiac death in the region “to about what we see in our country,” Dr. Bernhardt said at the AAP meeting.
An analysis of sudden deaths in U.S. athletes since 1980 showed that about 4% of the sudden cardiac deaths in athletes under 35 since 1980 have been caused by ARVD, he noted (Circulation 2009;119:1085-92). The most common cause, reportedly responsible for about 36% of the sudden cardiac deaths, was hypertrophic cardiomyopathy. (Cardiovascular sudden deaths occurred at a rate of less than 80/year, according to the study.)
The incidence of sudden cardiac death is about 1 in 75,000 competitive athletes, Dr. Bernhardt said, so “you're truly trying to find a needle in a haystack.”
Studies of ECG abnormalities in athletes have clearly shown that borderline or false-positive results are common. In one Italian study, investigators determined that the test's sensitivity was 51%, its specificity 61%, its positive predictive value 7%, and its negative predictive value 96%, he said.
The potential for false-positive results, combined with the size of the U.S. population, limited financial resources, and limited numbers of trained physicians, make the routine use of tests such as ECGs unwise in this country, Dr. Bernhardt added.
The AAP and its monograph cosponsors recommend a thorough personal and family history and physical exam as the best screening strategy. The monograph will incorporate the American Heart Association's recommendations for cardiovascular screening, along with questions about unexplained seizure and whether any family member or relative has died of sudden infant death syndrome, Dr. Bernhardt said.
The monograph will recommend that evaluations be performed in a primary care physician's office for better continuity of care, “rather than in station-based formats at schools or drugstores,” he said.
The new recommendations will also address legal concerns such as the ability of primary care or team physicians to rescind participation clearance based on changes in an athlete's health status, he said.
The AAP, along with the American Academy of Family Physicians and several sports medicine associations, has been a sponsoring organization of previous versions of the Preparticipation Physical Evaluation monograph. The new monograph will be sold, but the updated history and physical exam forms contained in the book will be available free of charge through sponsoring organizations.
Graves' Disease in Pregnancy: Choosing the Tx
WASHINGTON — Given growing concerns about propylthiouracil-related liver toxicity, “it may be that we should be weighing the relative risks” of this drug and methimazole for the treatment of Graves' disease during pregnancy, Dr. Susan J. Mandel said.
Propylthiouracil (PTU) has been the preferred therapy for Graves' disease during pregnancy, especially during first-trimester organogenesis, because methimazole (MMI) and carbimazole have been associated with aplasia cutis and rare embryopathy including choanal atresia, esophageal atresia, tracheoesophageal fistula, and athelia.
None of these congenital anomalies has been reported with the use of PTU, Dr. Mandel said at an American Thyroid Association-sponsored meeting. Dr. Mandel is associate chief of the division of endocrinology, diabetes, and metabolism at the University of Pennsylvania, Philadelphia.
Last month, the Food and Drug Administration issued a warning about the risk of severe liver injury associated with the use of PTU with the treatment of Graves' disease. “After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil, compared with an alternative treatment for Graves' disease, methimazole,” Dr. Amy Egan, deputy director for safety, division of metabolism and endocrinology products, FDA Center for Drug Evaluation and Research, said in a statement.
“Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first 6 months after initiating therapy.”
The FDA is advising health care professionals to reserve PTU for patients in their first trimester of pregnancy or those who are intolerant of or allergic to methimazole.
The FDA statement, posted on the agency's MedWatch Web site, said that 32 cases of serious liver injury were reported to the FDA from 1969, when the agency's adverse event reporting program was established, through October 2008. Of these cases, 22 were in adults, and included 12 fatalities and 5 liver transplants. Among the 10 pediatric cases, there were 6 reports of liver transplants and 1 fatality, according to the statement.
On the basis of an analysis of these reports, the FDA has determined that the risk of hepatotoxicity is greater with PTU than with MMI. The FDA received only five reports of serious liver injury associated with MMI, which was approved in 1950.
The FDA announced plans to change the prescribing information for PTU to reflect the hepatotoxicity warning
Concerns about PTU's hepatotoxicity have come largely from the pediatric community. Last year, the National Institute of Child Health and Human Development (NICHD) held a conference on “hepatic toxicity following treatment for pediatric Graves' disease.” And most recently, Dr. Scott A. Rivkees of Yale University, New Haven, Conn., and Dr. Donald R. Mattison of NICHD called for an end to the use of PTU in children.
In a letter to the editor published in the April 9 issue of the New England Journal of Medicine (2009;360:1574-5), Dr. Rivkees and Dr. Mattison said that PTU-induced liver failure may occur in 1 in 2,000 to 1 in 4,000 treated children, with nearly 10 times that range developing reversible PTU-induced liver injury.
In the context of Graves' disease in pregnancy, Dr. Mandel said, “it may be that we should be rethinking, what are the relative risks of hepatotoxicity with PTU versus the very rare embryopathy reported with methimazole [and carbimazole].”
Because the changes apparently caused by MMI “all occur by 8-10 weeks' gestation, and some even earlier, there may be a rationale” to using PTU into early pregnancy and then switching to methimazole afterwards,” added Dr. Mandel, also professor of medicine and radiology at the University of Pennsylvania.
The original recommendations to use PTU in pregnancy—before the teratogenic effects of MMI were reported—came from studies suggesting that PTU was less likely to cross the placenta. More recent data acquired through the use of newer measurement techniques have challenged this, demonstrating a similar degree of transplacental passage with both drugs, she noted.
WASHINGTON — Given growing concerns about propylthiouracil-related liver toxicity, “it may be that we should be weighing the relative risks” of this drug and methimazole for the treatment of Graves' disease during pregnancy, Dr. Susan J. Mandel said.
Propylthiouracil (PTU) has been the preferred therapy for Graves' disease during pregnancy, especially during first-trimester organogenesis, because methimazole (MMI) and carbimazole have been associated with aplasia cutis and rare embryopathy including choanal atresia, esophageal atresia, tracheoesophageal fistula, and athelia.
None of these congenital anomalies has been reported with the use of PTU, Dr. Mandel said at an American Thyroid Association-sponsored meeting. Dr. Mandel is associate chief of the division of endocrinology, diabetes, and metabolism at the University of Pennsylvania, Philadelphia.
Last month, the Food and Drug Administration issued a warning about the risk of severe liver injury associated with the use of PTU with the treatment of Graves' disease. “After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil, compared with an alternative treatment for Graves' disease, methimazole,” Dr. Amy Egan, deputy director for safety, division of metabolism and endocrinology products, FDA Center for Drug Evaluation and Research, said in a statement.
“Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first 6 months after initiating therapy.”
The FDA is advising health care professionals to reserve PTU for patients in their first trimester of pregnancy or those who are intolerant of or allergic to methimazole.
The FDA statement, posted on the agency's MedWatch Web site, said that 32 cases of serious liver injury were reported to the FDA from 1969, when the agency's adverse event reporting program was established, through October 2008. Of these cases, 22 were in adults, and included 12 fatalities and 5 liver transplants. Among the 10 pediatric cases, there were 6 reports of liver transplants and 1 fatality, according to the statement.
On the basis of an analysis of these reports, the FDA has determined that the risk of hepatotoxicity is greater with PTU than with MMI. The FDA received only five reports of serious liver injury associated with MMI, which was approved in 1950.
The FDA announced plans to change the prescribing information for PTU to reflect the hepatotoxicity warning
Concerns about PTU's hepatotoxicity have come largely from the pediatric community. Last year, the National Institute of Child Health and Human Development (NICHD) held a conference on “hepatic toxicity following treatment for pediatric Graves' disease.” And most recently, Dr. Scott A. Rivkees of Yale University, New Haven, Conn., and Dr. Donald R. Mattison of NICHD called for an end to the use of PTU in children.
In a letter to the editor published in the April 9 issue of the New England Journal of Medicine (2009;360:1574-5), Dr. Rivkees and Dr. Mattison said that PTU-induced liver failure may occur in 1 in 2,000 to 1 in 4,000 treated children, with nearly 10 times that range developing reversible PTU-induced liver injury.
In the context of Graves' disease in pregnancy, Dr. Mandel said, “it may be that we should be rethinking, what are the relative risks of hepatotoxicity with PTU versus the very rare embryopathy reported with methimazole [and carbimazole].”
Because the changes apparently caused by MMI “all occur by 8-10 weeks' gestation, and some even earlier, there may be a rationale” to using PTU into early pregnancy and then switching to methimazole afterwards,” added Dr. Mandel, also professor of medicine and radiology at the University of Pennsylvania.
The original recommendations to use PTU in pregnancy—before the teratogenic effects of MMI were reported—came from studies suggesting that PTU was less likely to cross the placenta. More recent data acquired through the use of newer measurement techniques have challenged this, demonstrating a similar degree of transplacental passage with both drugs, she noted.
WASHINGTON — Given growing concerns about propylthiouracil-related liver toxicity, “it may be that we should be weighing the relative risks” of this drug and methimazole for the treatment of Graves' disease during pregnancy, Dr. Susan J. Mandel said.
Propylthiouracil (PTU) has been the preferred therapy for Graves' disease during pregnancy, especially during first-trimester organogenesis, because methimazole (MMI) and carbimazole have been associated with aplasia cutis and rare embryopathy including choanal atresia, esophageal atresia, tracheoesophageal fistula, and athelia.
None of these congenital anomalies has been reported with the use of PTU, Dr. Mandel said at an American Thyroid Association-sponsored meeting. Dr. Mandel is associate chief of the division of endocrinology, diabetes, and metabolism at the University of Pennsylvania, Philadelphia.
Last month, the Food and Drug Administration issued a warning about the risk of severe liver injury associated with the use of PTU with the treatment of Graves' disease. “After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil, compared with an alternative treatment for Graves' disease, methimazole,” Dr. Amy Egan, deputy director for safety, division of metabolism and endocrinology products, FDA Center for Drug Evaluation and Research, said in a statement.
“Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first 6 months after initiating therapy.”
The FDA is advising health care professionals to reserve PTU for patients in their first trimester of pregnancy or those who are intolerant of or allergic to methimazole.
The FDA statement, posted on the agency's MedWatch Web site, said that 32 cases of serious liver injury were reported to the FDA from 1969, when the agency's adverse event reporting program was established, through October 2008. Of these cases, 22 were in adults, and included 12 fatalities and 5 liver transplants. Among the 10 pediatric cases, there were 6 reports of liver transplants and 1 fatality, according to the statement.
On the basis of an analysis of these reports, the FDA has determined that the risk of hepatotoxicity is greater with PTU than with MMI. The FDA received only five reports of serious liver injury associated with MMI, which was approved in 1950.
The FDA announced plans to change the prescribing information for PTU to reflect the hepatotoxicity warning
Concerns about PTU's hepatotoxicity have come largely from the pediatric community. Last year, the National Institute of Child Health and Human Development (NICHD) held a conference on “hepatic toxicity following treatment for pediatric Graves' disease.” And most recently, Dr. Scott A. Rivkees of Yale University, New Haven, Conn., and Dr. Donald R. Mattison of NICHD called for an end to the use of PTU in children.
In a letter to the editor published in the April 9 issue of the New England Journal of Medicine (2009;360:1574-5), Dr. Rivkees and Dr. Mattison said that PTU-induced liver failure may occur in 1 in 2,000 to 1 in 4,000 treated children, with nearly 10 times that range developing reversible PTU-induced liver injury.
In the context of Graves' disease in pregnancy, Dr. Mandel said, “it may be that we should be rethinking, what are the relative risks of hepatotoxicity with PTU versus the very rare embryopathy reported with methimazole [and carbimazole].”
Because the changes apparently caused by MMI “all occur by 8-10 weeks' gestation, and some even earlier, there may be a rationale” to using PTU into early pregnancy and then switching to methimazole afterwards,” added Dr. Mandel, also professor of medicine and radiology at the University of Pennsylvania.
The original recommendations to use PTU in pregnancy—before the teratogenic effects of MMI were reported—came from studies suggesting that PTU was less likely to cross the placenta. More recent data acquired through the use of newer measurement techniques have challenged this, demonstrating a similar degree of transplacental passage with both drugs, she noted.