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Chronic insomnia afflicts one in three perimenopausal women
LAS VEGAS – Sleeplessness is both common and distressing for women in midlife, according to a new analysis of data from a large observational study.
One-third of women at all stages of the menopausal transition reported sleep disturbance that met the clinical criteria for insomnia, regardless of many markers of health and socioeconomic status, Colleen L. Ciano, Ph.D., reported at the NAMS 2015 annual meeting.
Acute insomnia is prevalent in adults, and women are known to suffer more than men from chronic insomnia. Perimenopausal women, in particular, may have increased sleep disturbances.
Dr. Ciano, a postdoctoral fellow at the University of Pennsylvania, Philadelphia, and her colleagues used data from the large, longitudinal Study of Women’s Health Across the Nation (SWAN) to ascertain insomnia’s prevalence in perimenopausal and surgically menopausal women. Using SWAN study data, she also attempted to tease out factors that might increase a woman’s risk for chronic insomnia.
SWAN, said Dr. Ciano, was designed to examine the health of midlife women, gathering data from 3,302 women with a mean age of 45.9 years. Ten years of study data are now available from an ethnically diverse sample of women participating at seven sites across the United States.
Four questions from the SWAN questionnaire were identified for analysis as dependent variables. The questions related to trouble falling asleep, nighttime wakings, early-morning wakings, and a subjective rating of sleep quality over 2 weeks. Women were stratified into early or late menopause, or surgical menopause.
More than one-third of women at all stages of the midlife transition, or who were in surgical menopause, reported diagnosable insomnia. On the whole, insomnia increased for women over the study period. Waking after sleep onset also increased for perimenopausal women as they moved through menopause, from 26% to 36%. Sleep quality, as a bifurcated measure of sleep quality derived from a four-point scale, also dropped over the study period.
During the SWAN data collection period, the number of perimenopausal women who met at least one of the American Academy of Sleep Medicine criteria for insomnia rose from just over 30% to just over 40%, while the number of women who reported no insomnia symptoms fell steeply, dropping from just under 70% to approximately 50%.
When Dr. Ciano analyzed the prevalence of insomnia by perimenopausal stage, she found more insomnia in late-perimenopausal women (prevalence 31%-48%), compared with those in early menopause (31%-59%).
Women in late perimenopause had an odds ratio of 1.3 of reporting any symptom of insomnia, compared with those in early menopause, according to Dr. Ciano.
Women who were heavier, older, or depressed, as well as those having night sweats, were all more likely to suffer from insomnia on multivariable analysis (all P=0.002 or less). Factors that did not influence insomnia included marital status, tobacco or alcohol use, race/ethnicity, socioeconomic status, and many comorbidities including diabetes, hypertension, and cardiovascular disease.
Dr. Ciano advised clinicians to pay attention to these findings and initiate insomnia screenings. Routine evaluation of perimenopausal women should include careful questioning and an assessment of sleep patterns and problems. This is especially important since obesity, diabetes, and cardiovascular disease are all prevalent chronic illnesses that can be impacted by insomnia, she said.
Future studies should include physiologic measures and objective sleep data, which could be correlated with subjective reports, said Dr. Ciano. Sleep diaries can be an adjunct to observational and objective data, and can be correlated with such objective measures as endogenous hormone levels and objective vasomotor symptom monitoring.
Dr. Ciano’s research was supported by the National Institute for Nursing Research, Pennsylvana State University, and the Beta Sigma chapter of Sigma Theta Tau. She reported having no relevant financial disclosures.
On Twitter @karioakes
LAS VEGAS – Sleeplessness is both common and distressing for women in midlife, according to a new analysis of data from a large observational study.
One-third of women at all stages of the menopausal transition reported sleep disturbance that met the clinical criteria for insomnia, regardless of many markers of health and socioeconomic status, Colleen L. Ciano, Ph.D., reported at the NAMS 2015 annual meeting.
Acute insomnia is prevalent in adults, and women are known to suffer more than men from chronic insomnia. Perimenopausal women, in particular, may have increased sleep disturbances.
Dr. Ciano, a postdoctoral fellow at the University of Pennsylvania, Philadelphia, and her colleagues used data from the large, longitudinal Study of Women’s Health Across the Nation (SWAN) to ascertain insomnia’s prevalence in perimenopausal and surgically menopausal women. Using SWAN study data, she also attempted to tease out factors that might increase a woman’s risk for chronic insomnia.
SWAN, said Dr. Ciano, was designed to examine the health of midlife women, gathering data from 3,302 women with a mean age of 45.9 years. Ten years of study data are now available from an ethnically diverse sample of women participating at seven sites across the United States.
Four questions from the SWAN questionnaire were identified for analysis as dependent variables. The questions related to trouble falling asleep, nighttime wakings, early-morning wakings, and a subjective rating of sleep quality over 2 weeks. Women were stratified into early or late menopause, or surgical menopause.
More than one-third of women at all stages of the midlife transition, or who were in surgical menopause, reported diagnosable insomnia. On the whole, insomnia increased for women over the study period. Waking after sleep onset also increased for perimenopausal women as they moved through menopause, from 26% to 36%. Sleep quality, as a bifurcated measure of sleep quality derived from a four-point scale, also dropped over the study period.
During the SWAN data collection period, the number of perimenopausal women who met at least one of the American Academy of Sleep Medicine criteria for insomnia rose from just over 30% to just over 40%, while the number of women who reported no insomnia symptoms fell steeply, dropping from just under 70% to approximately 50%.
When Dr. Ciano analyzed the prevalence of insomnia by perimenopausal stage, she found more insomnia in late-perimenopausal women (prevalence 31%-48%), compared with those in early menopause (31%-59%).
Women in late perimenopause had an odds ratio of 1.3 of reporting any symptom of insomnia, compared with those in early menopause, according to Dr. Ciano.
Women who were heavier, older, or depressed, as well as those having night sweats, were all more likely to suffer from insomnia on multivariable analysis (all P=0.002 or less). Factors that did not influence insomnia included marital status, tobacco or alcohol use, race/ethnicity, socioeconomic status, and many comorbidities including diabetes, hypertension, and cardiovascular disease.
Dr. Ciano advised clinicians to pay attention to these findings and initiate insomnia screenings. Routine evaluation of perimenopausal women should include careful questioning and an assessment of sleep patterns and problems. This is especially important since obesity, diabetes, and cardiovascular disease are all prevalent chronic illnesses that can be impacted by insomnia, she said.
Future studies should include physiologic measures and objective sleep data, which could be correlated with subjective reports, said Dr. Ciano. Sleep diaries can be an adjunct to observational and objective data, and can be correlated with such objective measures as endogenous hormone levels and objective vasomotor symptom monitoring.
Dr. Ciano’s research was supported by the National Institute for Nursing Research, Pennsylvana State University, and the Beta Sigma chapter of Sigma Theta Tau. She reported having no relevant financial disclosures.
On Twitter @karioakes
LAS VEGAS – Sleeplessness is both common and distressing for women in midlife, according to a new analysis of data from a large observational study.
One-third of women at all stages of the menopausal transition reported sleep disturbance that met the clinical criteria for insomnia, regardless of many markers of health and socioeconomic status, Colleen L. Ciano, Ph.D., reported at the NAMS 2015 annual meeting.
Acute insomnia is prevalent in adults, and women are known to suffer more than men from chronic insomnia. Perimenopausal women, in particular, may have increased sleep disturbances.
Dr. Ciano, a postdoctoral fellow at the University of Pennsylvania, Philadelphia, and her colleagues used data from the large, longitudinal Study of Women’s Health Across the Nation (SWAN) to ascertain insomnia’s prevalence in perimenopausal and surgically menopausal women. Using SWAN study data, she also attempted to tease out factors that might increase a woman’s risk for chronic insomnia.
SWAN, said Dr. Ciano, was designed to examine the health of midlife women, gathering data from 3,302 women with a mean age of 45.9 years. Ten years of study data are now available from an ethnically diverse sample of women participating at seven sites across the United States.
Four questions from the SWAN questionnaire were identified for analysis as dependent variables. The questions related to trouble falling asleep, nighttime wakings, early-morning wakings, and a subjective rating of sleep quality over 2 weeks. Women were stratified into early or late menopause, or surgical menopause.
More than one-third of women at all stages of the midlife transition, or who were in surgical menopause, reported diagnosable insomnia. On the whole, insomnia increased for women over the study period. Waking after sleep onset also increased for perimenopausal women as they moved through menopause, from 26% to 36%. Sleep quality, as a bifurcated measure of sleep quality derived from a four-point scale, also dropped over the study period.
During the SWAN data collection period, the number of perimenopausal women who met at least one of the American Academy of Sleep Medicine criteria for insomnia rose from just over 30% to just over 40%, while the number of women who reported no insomnia symptoms fell steeply, dropping from just under 70% to approximately 50%.
When Dr. Ciano analyzed the prevalence of insomnia by perimenopausal stage, she found more insomnia in late-perimenopausal women (prevalence 31%-48%), compared with those in early menopause (31%-59%).
Women in late perimenopause had an odds ratio of 1.3 of reporting any symptom of insomnia, compared with those in early menopause, according to Dr. Ciano.
Women who were heavier, older, or depressed, as well as those having night sweats, were all more likely to suffer from insomnia on multivariable analysis (all P=0.002 or less). Factors that did not influence insomnia included marital status, tobacco or alcohol use, race/ethnicity, socioeconomic status, and many comorbidities including diabetes, hypertension, and cardiovascular disease.
Dr. Ciano advised clinicians to pay attention to these findings and initiate insomnia screenings. Routine evaluation of perimenopausal women should include careful questioning and an assessment of sleep patterns and problems. This is especially important since obesity, diabetes, and cardiovascular disease are all prevalent chronic illnesses that can be impacted by insomnia, she said.
Future studies should include physiologic measures and objective sleep data, which could be correlated with subjective reports, said Dr. Ciano. Sleep diaries can be an adjunct to observational and objective data, and can be correlated with such objective measures as endogenous hormone levels and objective vasomotor symptom monitoring.
Dr. Ciano’s research was supported by the National Institute for Nursing Research, Pennsylvana State University, and the Beta Sigma chapter of Sigma Theta Tau. She reported having no relevant financial disclosures.
On Twitter @karioakes
AT THE NAMS 2015 ANNUAL MEETING
Key clinical point: One in three perimenopausal women has persistent insomnia.
Major finding: An average of one-third of perimenopausal women have significant symptoms of insomnia, higher than age-matched prevalence in the general population.
Data source: Analysis of the Study of Women’s Health Across the Nation (SWAN), a multi-site longitudinal study of 3,302 ethnically diverse midlife-aged women.
Disclosures: The research was supported by the National Institute for Nursing Research, Pennsylvana State University, and the Beta Sigma chapter of Sigma Theta Tau. Dr. Ciano reported having no relevant financial disclosures.
NICE can’t recommend new sepsis tests
Photo by William Weinert
The UK’s National Institute for Health and Care Excellence (NICE) has said there is not enough evidence to recommend 3 new blood tests for routine use in the National Health Service.
The tests are designed to identify bacteria and fungi in the bloodstream more rapidly than current tests.
According to NICE, there is too much uncertainty regarding the accuracy of the new tests and the size of benefit they might confer for patients with suspected sepsis.
The tests in question are LightCycler SeptiFast Test MGRADE (Roche Diagnostics), SepsiTest (Molzym Molecular Diagnostics), and IRIDICA BAC BSI assay (Abbott Diagnostics).
They are used to analyze whole blood samples for bacterial and fungal DNA, which may identify pathogens earlier than microbiology techniques. Microbiology techniques require blood samples to be incubated and cultured before pathogens can be identified.
The new tests are designed to enable earlier targeted treatment for patients with sepsis and reduce the use of broad-spectrum antimicrobials, which could help reduce future antimicrobial resistance.
“Rapid molecular tests that can identify which pathogens are the cause of an infection in hours rather than the days typically needed for traditional microbiology tests could ensure the right antibiotics are used much earlier in treatment,” said Carole Longson, NICE Health Technology Evaluation Centre Director.
“This, in turn, could improve outcomes for patients with suspected sepsis as well as help to reduce the spread of resistant microbes. However, the committee [advising NICE] concluded that the tests may offer clinical benefit, but there is too much uncertainty in the size of the benefit to determine the effect of introducing the tests into clinical practice.”
“The committee also concluded that, although the rapid molecular tests might provide results more quickly, there was too much uncertainty in the accuracy of the tests for clinicians to be able to base a decision on whether to withdraw or continue antibiotics. The committee therefore decided that further research should be encouraged to determine the clinical scenarios in which the tests may offer most benefit.”
NICE’s draft diagnostics guidance on the LightCycler SeptiFast Test MGRADE, SepsiTest, and IRIDICA BAC BSI assay is available on the NICE website. The closing date for comments on this draft guidance is October 21, 2015.
Photo by William Weinert
The UK’s National Institute for Health and Care Excellence (NICE) has said there is not enough evidence to recommend 3 new blood tests for routine use in the National Health Service.
The tests are designed to identify bacteria and fungi in the bloodstream more rapidly than current tests.
According to NICE, there is too much uncertainty regarding the accuracy of the new tests and the size of benefit they might confer for patients with suspected sepsis.
The tests in question are LightCycler SeptiFast Test MGRADE (Roche Diagnostics), SepsiTest (Molzym Molecular Diagnostics), and IRIDICA BAC BSI assay (Abbott Diagnostics).
They are used to analyze whole blood samples for bacterial and fungal DNA, which may identify pathogens earlier than microbiology techniques. Microbiology techniques require blood samples to be incubated and cultured before pathogens can be identified.
The new tests are designed to enable earlier targeted treatment for patients with sepsis and reduce the use of broad-spectrum antimicrobials, which could help reduce future antimicrobial resistance.
“Rapid molecular tests that can identify which pathogens are the cause of an infection in hours rather than the days typically needed for traditional microbiology tests could ensure the right antibiotics are used much earlier in treatment,” said Carole Longson, NICE Health Technology Evaluation Centre Director.
“This, in turn, could improve outcomes for patients with suspected sepsis as well as help to reduce the spread of resistant microbes. However, the committee [advising NICE] concluded that the tests may offer clinical benefit, but there is too much uncertainty in the size of the benefit to determine the effect of introducing the tests into clinical practice.”
“The committee also concluded that, although the rapid molecular tests might provide results more quickly, there was too much uncertainty in the accuracy of the tests for clinicians to be able to base a decision on whether to withdraw or continue antibiotics. The committee therefore decided that further research should be encouraged to determine the clinical scenarios in which the tests may offer most benefit.”
NICE’s draft diagnostics guidance on the LightCycler SeptiFast Test MGRADE, SepsiTest, and IRIDICA BAC BSI assay is available on the NICE website. The closing date for comments on this draft guidance is October 21, 2015.
Photo by William Weinert
The UK’s National Institute for Health and Care Excellence (NICE) has said there is not enough evidence to recommend 3 new blood tests for routine use in the National Health Service.
The tests are designed to identify bacteria and fungi in the bloodstream more rapidly than current tests.
According to NICE, there is too much uncertainty regarding the accuracy of the new tests and the size of benefit they might confer for patients with suspected sepsis.
The tests in question are LightCycler SeptiFast Test MGRADE (Roche Diagnostics), SepsiTest (Molzym Molecular Diagnostics), and IRIDICA BAC BSI assay (Abbott Diagnostics).
They are used to analyze whole blood samples for bacterial and fungal DNA, which may identify pathogens earlier than microbiology techniques. Microbiology techniques require blood samples to be incubated and cultured before pathogens can be identified.
The new tests are designed to enable earlier targeted treatment for patients with sepsis and reduce the use of broad-spectrum antimicrobials, which could help reduce future antimicrobial resistance.
“Rapid molecular tests that can identify which pathogens are the cause of an infection in hours rather than the days typically needed for traditional microbiology tests could ensure the right antibiotics are used much earlier in treatment,” said Carole Longson, NICE Health Technology Evaluation Centre Director.
“This, in turn, could improve outcomes for patients with suspected sepsis as well as help to reduce the spread of resistant microbes. However, the committee [advising NICE] concluded that the tests may offer clinical benefit, but there is too much uncertainty in the size of the benefit to determine the effect of introducing the tests into clinical practice.”
“The committee also concluded that, although the rapid molecular tests might provide results more quickly, there was too much uncertainty in the accuracy of the tests for clinicians to be able to base a decision on whether to withdraw or continue antibiotics. The committee therefore decided that further research should be encouraged to determine the clinical scenarios in which the tests may offer most benefit.”
NICE’s draft diagnostics guidance on the LightCycler SeptiFast Test MGRADE, SepsiTest, and IRIDICA BAC BSI assay is available on the NICE website. The closing date for comments on this draft guidance is October 21, 2015.
Progress in treating diabetic foot osteomyelitis
SAN DIEGO – The evidence-based treatment of diabetic foot osteomyelitis has jumped up to the next level as a result of two recent randomized clinical trials, the first-ever to address a couple of key contentious issues, experts agreed recently at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Dr. Eric Senneville presented highlights of the two randomized trials, one of which examined the optimal duration of antibiotic therapy in patients with nonsurgically treated diabetic foot osteomyelitis. The other study was the first-ever head-to-head randomized comparison of antibiotics versus conservative surgery.
He also touched on another new development in the treatment of diabetic foot osteomyelitis: surgically implanted topical antibiotics, which show promise in specific situations.
Dr. Senneville of Gustave Dron Hospital in Tourcoing, France, was senior investigator in the prospective, randomized, multicenter comparison of outcomes with 6 versus 12 weeks of open-label antibiotic therapy in 40 patients. All participants had bone biopsy–confirmed osteomyelitis with no ischemia, and none underwent any bone resection during the treatment period.
The 6-week regimen proved to be the winning strategy. It resulted in remission in 12 of 20 patients, a result not significantly different from the 14 of 20 remission rate with 12 weeks of treatment. Moreover, significant drug-related gastrointestinal side effects occurred in only three patients in the 6-week-treatment arm, compared with nine patients treated for 12 weeks. There was no difference between the two groups in rates of relapse, need for later bone resection, or spread of osteomyelitis (Diabetes Care. 2015 Feb;38[2]:302-7).
In the surgery-versus-antibiotics trial, investigators at the University of Madrid prospectively randomized 52 patients with diabetic foot osteomyelitis to 90 days of antibiotics with no surgery or to conservative surgery with 10 days of postoperative antibiotics. Dr. Senneville emphasized that this was a select patient population and at this point the results apply only to similar groups; that is, all participants had forefoot osteomyelitis without ischemia or necrosis. There were six dropouts: one in the medically treated arm and five in the surgical group.
The key finding: At 12 weeks of follow-up, main outcomes were similar in the two groups. Eighteen of 24 patients in the medically managed group achieved primary healing, for a 75% cure rate, not significantly different from the 86% rate – 19 of 22 patients cured – in the surgical group. Median time to healing was 7 weeks with antibiotics only and similar at 6 weeks with surgery. Four patients in the antibiotic group worsened and required surgery, while three in the surgery group required reoperation (Diabetes Care. 2014 Mar;37[3]:789-95).
Dr. Senneville noted that the reulceration rate was 10% in the medically treated group and twice that in the surgical group. A higher reulceration rate has also been seen in retrospective studies. It’s thought to result from what has been termed pressure transfer syndrome, which is particularly common among patients who undergo surgery on the first metatarsal head.
Dr. Edgar J. G. Peters of VU Academic Medical Center, Amsterdam, commented that the Spanish randomized trial of antibiotics versus surgery in diabetic osteomyelitis was sorely needed. All too often, he observed, earlier retrospective studies conducted by surgeons concluded that surgery was best, while those carried out by infectious disease specialists found the antiobiotics-only strategy to be superior. Skeptical unbiased physicians were left in the dark.
He noted that this important clinical trial as well as the major randomized trial of 6 versus 12 weeks of antibiotic therapy were published too late for inclusion in the recently released systematic review of treatments for diabetic foot infections conducted by the International Working Group on the Diabetic Foot (Diabetes Metab Res Rev. 2015 Sep 7. doi: 10.1002/dmrr.2706), for which both Dr. Peters and Dr. Senneville were coauthors.
Turning to the novel use of topical antibiotics in patients with diabetic foot osteomyelitis, Dr. Senneville described several potential advantages, including the attainment of optimal drug levels in the presence of peripheral vascular disease and in avascular spaces.
The idea is to place antibiotic-impregnated beads or bone cement in the space created by debridement and removal of infected bone. By filling the dead space, the antibiotic-impregnated cement may control the infection simmering in any areas of infected bone unintentionally left behind, while also reducing the risk of pressure transfer syndrome. The use of antibiotic-eluting bone cement has recently been shown to reduce the need for reoperation (J Foot Ankle Surg. 2015 Jul-Aug;54[4]:536-40).
Dr. Senneville reported serving on speakers’ bureaus for Novartis and Merck and as an advisor to Pfizer.
SAN DIEGO – The evidence-based treatment of diabetic foot osteomyelitis has jumped up to the next level as a result of two recent randomized clinical trials, the first-ever to address a couple of key contentious issues, experts agreed recently at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Dr. Eric Senneville presented highlights of the two randomized trials, one of which examined the optimal duration of antibiotic therapy in patients with nonsurgically treated diabetic foot osteomyelitis. The other study was the first-ever head-to-head randomized comparison of antibiotics versus conservative surgery.
He also touched on another new development in the treatment of diabetic foot osteomyelitis: surgically implanted topical antibiotics, which show promise in specific situations.
Dr. Senneville of Gustave Dron Hospital in Tourcoing, France, was senior investigator in the prospective, randomized, multicenter comparison of outcomes with 6 versus 12 weeks of open-label antibiotic therapy in 40 patients. All participants had bone biopsy–confirmed osteomyelitis with no ischemia, and none underwent any bone resection during the treatment period.
The 6-week regimen proved to be the winning strategy. It resulted in remission in 12 of 20 patients, a result not significantly different from the 14 of 20 remission rate with 12 weeks of treatment. Moreover, significant drug-related gastrointestinal side effects occurred in only three patients in the 6-week-treatment arm, compared with nine patients treated for 12 weeks. There was no difference between the two groups in rates of relapse, need for later bone resection, or spread of osteomyelitis (Diabetes Care. 2015 Feb;38[2]:302-7).
In the surgery-versus-antibiotics trial, investigators at the University of Madrid prospectively randomized 52 patients with diabetic foot osteomyelitis to 90 days of antibiotics with no surgery or to conservative surgery with 10 days of postoperative antibiotics. Dr. Senneville emphasized that this was a select patient population and at this point the results apply only to similar groups; that is, all participants had forefoot osteomyelitis without ischemia or necrosis. There were six dropouts: one in the medically treated arm and five in the surgical group.
The key finding: At 12 weeks of follow-up, main outcomes were similar in the two groups. Eighteen of 24 patients in the medically managed group achieved primary healing, for a 75% cure rate, not significantly different from the 86% rate – 19 of 22 patients cured – in the surgical group. Median time to healing was 7 weeks with antibiotics only and similar at 6 weeks with surgery. Four patients in the antibiotic group worsened and required surgery, while three in the surgery group required reoperation (Diabetes Care. 2014 Mar;37[3]:789-95).
Dr. Senneville noted that the reulceration rate was 10% in the medically treated group and twice that in the surgical group. A higher reulceration rate has also been seen in retrospective studies. It’s thought to result from what has been termed pressure transfer syndrome, which is particularly common among patients who undergo surgery on the first metatarsal head.
Dr. Edgar J. G. Peters of VU Academic Medical Center, Amsterdam, commented that the Spanish randomized trial of antibiotics versus surgery in diabetic osteomyelitis was sorely needed. All too often, he observed, earlier retrospective studies conducted by surgeons concluded that surgery was best, while those carried out by infectious disease specialists found the antiobiotics-only strategy to be superior. Skeptical unbiased physicians were left in the dark.
He noted that this important clinical trial as well as the major randomized trial of 6 versus 12 weeks of antibiotic therapy were published too late for inclusion in the recently released systematic review of treatments for diabetic foot infections conducted by the International Working Group on the Diabetic Foot (Diabetes Metab Res Rev. 2015 Sep 7. doi: 10.1002/dmrr.2706), for which both Dr. Peters and Dr. Senneville were coauthors.
Turning to the novel use of topical antibiotics in patients with diabetic foot osteomyelitis, Dr. Senneville described several potential advantages, including the attainment of optimal drug levels in the presence of peripheral vascular disease and in avascular spaces.
The idea is to place antibiotic-impregnated beads or bone cement in the space created by debridement and removal of infected bone. By filling the dead space, the antibiotic-impregnated cement may control the infection simmering in any areas of infected bone unintentionally left behind, while also reducing the risk of pressure transfer syndrome. The use of antibiotic-eluting bone cement has recently been shown to reduce the need for reoperation (J Foot Ankle Surg. 2015 Jul-Aug;54[4]:536-40).
Dr. Senneville reported serving on speakers’ bureaus for Novartis and Merck and as an advisor to Pfizer.
SAN DIEGO – The evidence-based treatment of diabetic foot osteomyelitis has jumped up to the next level as a result of two recent randomized clinical trials, the first-ever to address a couple of key contentious issues, experts agreed recently at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Dr. Eric Senneville presented highlights of the two randomized trials, one of which examined the optimal duration of antibiotic therapy in patients with nonsurgically treated diabetic foot osteomyelitis. The other study was the first-ever head-to-head randomized comparison of antibiotics versus conservative surgery.
He also touched on another new development in the treatment of diabetic foot osteomyelitis: surgically implanted topical antibiotics, which show promise in specific situations.
Dr. Senneville of Gustave Dron Hospital in Tourcoing, France, was senior investigator in the prospective, randomized, multicenter comparison of outcomes with 6 versus 12 weeks of open-label antibiotic therapy in 40 patients. All participants had bone biopsy–confirmed osteomyelitis with no ischemia, and none underwent any bone resection during the treatment period.
The 6-week regimen proved to be the winning strategy. It resulted in remission in 12 of 20 patients, a result not significantly different from the 14 of 20 remission rate with 12 weeks of treatment. Moreover, significant drug-related gastrointestinal side effects occurred in only three patients in the 6-week-treatment arm, compared with nine patients treated for 12 weeks. There was no difference between the two groups in rates of relapse, need for later bone resection, or spread of osteomyelitis (Diabetes Care. 2015 Feb;38[2]:302-7).
In the surgery-versus-antibiotics trial, investigators at the University of Madrid prospectively randomized 52 patients with diabetic foot osteomyelitis to 90 days of antibiotics with no surgery or to conservative surgery with 10 days of postoperative antibiotics. Dr. Senneville emphasized that this was a select patient population and at this point the results apply only to similar groups; that is, all participants had forefoot osteomyelitis without ischemia or necrosis. There were six dropouts: one in the medically treated arm and five in the surgical group.
The key finding: At 12 weeks of follow-up, main outcomes were similar in the two groups. Eighteen of 24 patients in the medically managed group achieved primary healing, for a 75% cure rate, not significantly different from the 86% rate – 19 of 22 patients cured – in the surgical group. Median time to healing was 7 weeks with antibiotics only and similar at 6 weeks with surgery. Four patients in the antibiotic group worsened and required surgery, while three in the surgery group required reoperation (Diabetes Care. 2014 Mar;37[3]:789-95).
Dr. Senneville noted that the reulceration rate was 10% in the medically treated group and twice that in the surgical group. A higher reulceration rate has also been seen in retrospective studies. It’s thought to result from what has been termed pressure transfer syndrome, which is particularly common among patients who undergo surgery on the first metatarsal head.
Dr. Edgar J. G. Peters of VU Academic Medical Center, Amsterdam, commented that the Spanish randomized trial of antibiotics versus surgery in diabetic osteomyelitis was sorely needed. All too often, he observed, earlier retrospective studies conducted by surgeons concluded that surgery was best, while those carried out by infectious disease specialists found the antiobiotics-only strategy to be superior. Skeptical unbiased physicians were left in the dark.
He noted that this important clinical trial as well as the major randomized trial of 6 versus 12 weeks of antibiotic therapy were published too late for inclusion in the recently released systematic review of treatments for diabetic foot infections conducted by the International Working Group on the Diabetic Foot (Diabetes Metab Res Rev. 2015 Sep 7. doi: 10.1002/dmrr.2706), for which both Dr. Peters and Dr. Senneville were coauthors.
Turning to the novel use of topical antibiotics in patients with diabetic foot osteomyelitis, Dr. Senneville described several potential advantages, including the attainment of optimal drug levels in the presence of peripheral vascular disease and in avascular spaces.
The idea is to place antibiotic-impregnated beads or bone cement in the space created by debridement and removal of infected bone. By filling the dead space, the antibiotic-impregnated cement may control the infection simmering in any areas of infected bone unintentionally left behind, while also reducing the risk of pressure transfer syndrome. The use of antibiotic-eluting bone cement has recently been shown to reduce the need for reoperation (J Foot Ankle Surg. 2015 Jul-Aug;54[4]:536-40).
Dr. Senneville reported serving on speakers’ bureaus for Novartis and Merck and as an advisor to Pfizer.
EXPERT ANALYSIS FROM ICAAC 2015
The 15-Year Itch
A 58-year-old woman presents to dermatology with a 15-year history of an itchy rash on her left leg. A native of India, she has been in this country for more than 20 years and enjoys generally good health.
But about 15 years ago, she experienced some personal problems that caused great stress. About that same time, she developed a small rash on her left leg, which she began to scratch.
Over time, the lesion has become larger and more pruritic, prompting her to scratch and rub it more. Lately, she has started to use a hairbrush to scratch it. The itching has taken on a whole new level of intensity.
Her primary care provider referred her to a wound care clinic, where her lesion was treated with twice-weekly whirlpool therapy, followed by debridement and dressing with a zinc oxide–based paste. Although this calmed the affected site a bit, when treatment ceased, the rash flared again.
EXAMINATION
The patient has type IV skin, consistent with her origins. The lesion is an impressive, elongated oval plaque measuring about 20 x 10 cm. It covers most of the anterolateral portion of her left leg and calf.
An underlying area of brown macular hyperpigmentation extends an additional 2 to 3 cm around the periphery of the plaque. The central area is slightly edematous, quite pink, and shiny. No focal breaks in the skin are observed. There is no increased warmth or tenderness on palpation.
What is the diagnosis?
DISCUSSION
This complaint and its location are typical of an extremely common dermatologic entity called lichen simplex chronicus (LSC), formerly known as neurodermatitis. All cases of LSC start with a relatively minor, itchy trigger—such as dry skin, eczema, or a bug bite—that the patient begins to scratch or rub. This has the effect of lowering the threshold for itching by making the nerves more numerous and sensitive; the patient then reacts by scratching or rubbing even more. As a result, the epidermal layer thickens and, particularly in patients with darker skin, postinflammatory hyperpigmentation develops.
The patient will persistently respond to the itching by scratching, a reaction that becomes habitual (and in some cases, even pleasurable) and perpetuates the cycle. Although the original insult has long since resolved, the problem has taken on a life of its own.
In the 15-year history of this lesion, the patient had seen a number of clinicians but, incredibly, never a dermatology provider. She had taken several courses of oral antibiotics, used triple-antibiotic ointment, and tried tea tree oil, emu oil, antifungal creams, and most recently, topical triamcinolone cream—the last of which helped a bit.
The actual solution to the problem is utterly simple, at least in concept: Stop scratching. But there’s the rub—the impulse to scratch is quite powerful, and habits are difficult to break.
That’s where we intervened, with the use of a stronger topical steroid ointment (clobetasol 0.05% bid) on an occlusive dressing (eg, an elastic bandage wrap), which potentiates the steroid and serves as a barrier to the patient’s scratching. A soft cast (eg, an Unna boot) would accomplish the same thing but is more troublesome to apply.
Given this patient’s skin type, this area of her leg will always be discolored. She should, however, be able to control the problem from now on. If this treatment attempt were to fail, a biopsy would be needed to rule out other diagnostic possibilities, such as psoriasis or lichen planus.
TAKE-HOME LEARNING POINTS
• Lichen simplex chronicus (LSC) is quite common, especially on the anterolateral leg.
• LSC is always secondary to an original trigger, such as xerosis, eczema, bug bite, or even psoriasis.
• The chronicity of the problem, sometimes extreme (as in this case), is not only common but often diagnostic.
• Postinflammatory color changes, especially on darker skinned individuals, are common with LSC.
• Other common areas for LSC include the scrotum/vulvae and nuchal scalp.
A 58-year-old woman presents to dermatology with a 15-year history of an itchy rash on her left leg. A native of India, she has been in this country for more than 20 years and enjoys generally good health.
But about 15 years ago, she experienced some personal problems that caused great stress. About that same time, she developed a small rash on her left leg, which she began to scratch.
Over time, the lesion has become larger and more pruritic, prompting her to scratch and rub it more. Lately, she has started to use a hairbrush to scratch it. The itching has taken on a whole new level of intensity.
Her primary care provider referred her to a wound care clinic, where her lesion was treated with twice-weekly whirlpool therapy, followed by debridement and dressing with a zinc oxide–based paste. Although this calmed the affected site a bit, when treatment ceased, the rash flared again.
EXAMINATION
The patient has type IV skin, consistent with her origins. The lesion is an impressive, elongated oval plaque measuring about 20 x 10 cm. It covers most of the anterolateral portion of her left leg and calf.
An underlying area of brown macular hyperpigmentation extends an additional 2 to 3 cm around the periphery of the plaque. The central area is slightly edematous, quite pink, and shiny. No focal breaks in the skin are observed. There is no increased warmth or tenderness on palpation.
What is the diagnosis?
DISCUSSION
This complaint and its location are typical of an extremely common dermatologic entity called lichen simplex chronicus (LSC), formerly known as neurodermatitis. All cases of LSC start with a relatively minor, itchy trigger—such as dry skin, eczema, or a bug bite—that the patient begins to scratch or rub. This has the effect of lowering the threshold for itching by making the nerves more numerous and sensitive; the patient then reacts by scratching or rubbing even more. As a result, the epidermal layer thickens and, particularly in patients with darker skin, postinflammatory hyperpigmentation develops.
The patient will persistently respond to the itching by scratching, a reaction that becomes habitual (and in some cases, even pleasurable) and perpetuates the cycle. Although the original insult has long since resolved, the problem has taken on a life of its own.
In the 15-year history of this lesion, the patient had seen a number of clinicians but, incredibly, never a dermatology provider. She had taken several courses of oral antibiotics, used triple-antibiotic ointment, and tried tea tree oil, emu oil, antifungal creams, and most recently, topical triamcinolone cream—the last of which helped a bit.
The actual solution to the problem is utterly simple, at least in concept: Stop scratching. But there’s the rub—the impulse to scratch is quite powerful, and habits are difficult to break.
That’s where we intervened, with the use of a stronger topical steroid ointment (clobetasol 0.05% bid) on an occlusive dressing (eg, an elastic bandage wrap), which potentiates the steroid and serves as a barrier to the patient’s scratching. A soft cast (eg, an Unna boot) would accomplish the same thing but is more troublesome to apply.
Given this patient’s skin type, this area of her leg will always be discolored. She should, however, be able to control the problem from now on. If this treatment attempt were to fail, a biopsy would be needed to rule out other diagnostic possibilities, such as psoriasis or lichen planus.
TAKE-HOME LEARNING POINTS
• Lichen simplex chronicus (LSC) is quite common, especially on the anterolateral leg.
• LSC is always secondary to an original trigger, such as xerosis, eczema, bug bite, or even psoriasis.
• The chronicity of the problem, sometimes extreme (as in this case), is not only common but often diagnostic.
• Postinflammatory color changes, especially on darker skinned individuals, are common with LSC.
• Other common areas for LSC include the scrotum/vulvae and nuchal scalp.
A 58-year-old woman presents to dermatology with a 15-year history of an itchy rash on her left leg. A native of India, she has been in this country for more than 20 years and enjoys generally good health.
But about 15 years ago, she experienced some personal problems that caused great stress. About that same time, she developed a small rash on her left leg, which she began to scratch.
Over time, the lesion has become larger and more pruritic, prompting her to scratch and rub it more. Lately, she has started to use a hairbrush to scratch it. The itching has taken on a whole new level of intensity.
Her primary care provider referred her to a wound care clinic, where her lesion was treated with twice-weekly whirlpool therapy, followed by debridement and dressing with a zinc oxide–based paste. Although this calmed the affected site a bit, when treatment ceased, the rash flared again.
EXAMINATION
The patient has type IV skin, consistent with her origins. The lesion is an impressive, elongated oval plaque measuring about 20 x 10 cm. It covers most of the anterolateral portion of her left leg and calf.
An underlying area of brown macular hyperpigmentation extends an additional 2 to 3 cm around the periphery of the plaque. The central area is slightly edematous, quite pink, and shiny. No focal breaks in the skin are observed. There is no increased warmth or tenderness on palpation.
What is the diagnosis?
DISCUSSION
This complaint and its location are typical of an extremely common dermatologic entity called lichen simplex chronicus (LSC), formerly known as neurodermatitis. All cases of LSC start with a relatively minor, itchy trigger—such as dry skin, eczema, or a bug bite—that the patient begins to scratch or rub. This has the effect of lowering the threshold for itching by making the nerves more numerous and sensitive; the patient then reacts by scratching or rubbing even more. As a result, the epidermal layer thickens and, particularly in patients with darker skin, postinflammatory hyperpigmentation develops.
The patient will persistently respond to the itching by scratching, a reaction that becomes habitual (and in some cases, even pleasurable) and perpetuates the cycle. Although the original insult has long since resolved, the problem has taken on a life of its own.
In the 15-year history of this lesion, the patient had seen a number of clinicians but, incredibly, never a dermatology provider. She had taken several courses of oral antibiotics, used triple-antibiotic ointment, and tried tea tree oil, emu oil, antifungal creams, and most recently, topical triamcinolone cream—the last of which helped a bit.
The actual solution to the problem is utterly simple, at least in concept: Stop scratching. But there’s the rub—the impulse to scratch is quite powerful, and habits are difficult to break.
That’s where we intervened, with the use of a stronger topical steroid ointment (clobetasol 0.05% bid) on an occlusive dressing (eg, an elastic bandage wrap), which potentiates the steroid and serves as a barrier to the patient’s scratching. A soft cast (eg, an Unna boot) would accomplish the same thing but is more troublesome to apply.
Given this patient’s skin type, this area of her leg will always be discolored. She should, however, be able to control the problem from now on. If this treatment attempt were to fail, a biopsy would be needed to rule out other diagnostic possibilities, such as psoriasis or lichen planus.
TAKE-HOME LEARNING POINTS
• Lichen simplex chronicus (LSC) is quite common, especially on the anterolateral leg.
• LSC is always secondary to an original trigger, such as xerosis, eczema, bug bite, or even psoriasis.
• The chronicity of the problem, sometimes extreme (as in this case), is not only common but often diagnostic.
• Postinflammatory color changes, especially on darker skinned individuals, are common with LSC.
• Other common areas for LSC include the scrotum/vulvae and nuchal scalp.
MHM: Novel agents, combos show promise for relapsed/refractory CLL
CHICAGO – Consider using novel agents in chronic lymphocytic leukemia (CLL) patients who are refractory to treatment or who relapse within 2 years of first-line therapy, Dr. John G. Gribben said.
Ibrutinib or idelalisib/rituximab, or other novel agent combinations within clinical trials are his choice in these patients, thus fitness for therapy becomes irrelevant, he said at the American Society of Hematology Meeting on Hematologic Malignancies.
“Of course, I’m particularly excited by the results in CLL of ABT-199. We saw at [the International Workshop on CLL] last week that there are increasing numbers of patients who are on this therapy in combination with anti-CD20 monoclonal antibodies who are achieving minimal residual disease (MRD) eradication and are able to stop that therapy, unlike what we’ve been seeing,” he said. “I have a patient at my own center now who was treated with ABT-199 plus obinutuzumab within a clinical trial – a 17p deletion patient refractory to seven previous lines of therapy. Had a donor, I was trying to get him to transplant, and now he’s MRD-negative and off therapy, having had 6 months of therapy with ABT-199 and obinutuzumab. [This is] a very exciting combination.”
Other novel-novel agent combinations are also being looked at, he noted.
In CLL patients without 17p deletions who progress later than 2 years after initial chemotherapy, novel agents can be considered, as could alternative approaches with chemotherapy.
“But of course, in the setting of p53 deletions or mutations, then ibrutinib or idelalisib/rituximab, or novel agents like ABT-199 within clinical trials become the treatment approach to be thinking about,” he said.
CHICAGO – Consider using novel agents in chronic lymphocytic leukemia (CLL) patients who are refractory to treatment or who relapse within 2 years of first-line therapy, Dr. John G. Gribben said.
Ibrutinib or idelalisib/rituximab, or other novel agent combinations within clinical trials are his choice in these patients, thus fitness for therapy becomes irrelevant, he said at the American Society of Hematology Meeting on Hematologic Malignancies.
“Of course, I’m particularly excited by the results in CLL of ABT-199. We saw at [the International Workshop on CLL] last week that there are increasing numbers of patients who are on this therapy in combination with anti-CD20 monoclonal antibodies who are achieving minimal residual disease (MRD) eradication and are able to stop that therapy, unlike what we’ve been seeing,” he said. “I have a patient at my own center now who was treated with ABT-199 plus obinutuzumab within a clinical trial – a 17p deletion patient refractory to seven previous lines of therapy. Had a donor, I was trying to get him to transplant, and now he’s MRD-negative and off therapy, having had 6 months of therapy with ABT-199 and obinutuzumab. [This is] a very exciting combination.”
Other novel-novel agent combinations are also being looked at, he noted.
In CLL patients without 17p deletions who progress later than 2 years after initial chemotherapy, novel agents can be considered, as could alternative approaches with chemotherapy.
“But of course, in the setting of p53 deletions or mutations, then ibrutinib or idelalisib/rituximab, or novel agents like ABT-199 within clinical trials become the treatment approach to be thinking about,” he said.
CHICAGO – Consider using novel agents in chronic lymphocytic leukemia (CLL) patients who are refractory to treatment or who relapse within 2 years of first-line therapy, Dr. John G. Gribben said.
Ibrutinib or idelalisib/rituximab, or other novel agent combinations within clinical trials are his choice in these patients, thus fitness for therapy becomes irrelevant, he said at the American Society of Hematology Meeting on Hematologic Malignancies.
“Of course, I’m particularly excited by the results in CLL of ABT-199. We saw at [the International Workshop on CLL] last week that there are increasing numbers of patients who are on this therapy in combination with anti-CD20 monoclonal antibodies who are achieving minimal residual disease (MRD) eradication and are able to stop that therapy, unlike what we’ve been seeing,” he said. “I have a patient at my own center now who was treated with ABT-199 plus obinutuzumab within a clinical trial – a 17p deletion patient refractory to seven previous lines of therapy. Had a donor, I was trying to get him to transplant, and now he’s MRD-negative and off therapy, having had 6 months of therapy with ABT-199 and obinutuzumab. [This is] a very exciting combination.”
Other novel-novel agent combinations are also being looked at, he noted.
In CLL patients without 17p deletions who progress later than 2 years after initial chemotherapy, novel agents can be considered, as could alternative approaches with chemotherapy.
“But of course, in the setting of p53 deletions or mutations, then ibrutinib or idelalisib/rituximab, or novel agents like ABT-199 within clinical trials become the treatment approach to be thinking about,” he said.
EXPERT ANALYSIS FROM MHM 2015
MHM: Novel agents, combos show promise for relapsed/refractory CLL
CHICAGO – Consider using novel agents in chronic lymphocytic leukemia (CLL) patients who are refractory to treatment or who relapse within 2 years of first-line therapy, Dr. John G. Gribben said.
Ibrutinib or idelalisib/rituximab, or other novel agent combinations within clinical trials are his choice in these patients, thus fitness for therapy becomes irrelevant, he said at the American Society of Hematology Meeting on Hematologic Malignancies.
“Of course, I’m particularly excited by the results in CLL of ABT-199. We saw at [the International Workshop on CLL] last week that there are increasing numbers of patients who are on this therapy in combination with anti-CD20 monoclonal antibodies who are achieving minimal residual disease (MRD) eradication and are able to stop that therapy, unlike what we’ve been seeing,” he said. “I have a patient at my own center now who was treated with ABT-199 plus obinutuzumab within a clinical trial – a 17p deletion patient refractory to seven previous lines of therapy. Had a donor, I was trying to get him to transplant, and now he’s MRD-negative and off therapy, having had 6 months of therapy with ABT-199 and obinutuzumab. [This is] a very exciting combination.”
Other novel-novel agent combinations are also being looked at, he noted.
In CLL patients without 17p deletions who progress later than 2 years after initial chemotherapy, novel agents can be considered, as could alternative approaches with chemotherapy.
“But of course, in the setting of p53 deletions or mutations, then ibrutinib or idelalisib/rituximab, or novel agents like ABT-199 within clinical trials become the treatment approach to be thinking about,” he said.
CHICAGO – Consider using novel agents in chronic lymphocytic leukemia (CLL) patients who are refractory to treatment or who relapse within 2 years of first-line therapy, Dr. John G. Gribben said.
Ibrutinib or idelalisib/rituximab, or other novel agent combinations within clinical trials are his choice in these patients, thus fitness for therapy becomes irrelevant, he said at the American Society of Hematology Meeting on Hematologic Malignancies.
“Of course, I’m particularly excited by the results in CLL of ABT-199. We saw at [the International Workshop on CLL] last week that there are increasing numbers of patients who are on this therapy in combination with anti-CD20 monoclonal antibodies who are achieving minimal residual disease (MRD) eradication and are able to stop that therapy, unlike what we’ve been seeing,” he said. “I have a patient at my own center now who was treated with ABT-199 plus obinutuzumab within a clinical trial – a 17p deletion patient refractory to seven previous lines of therapy. Had a donor, I was trying to get him to transplant, and now he’s MRD-negative and off therapy, having had 6 months of therapy with ABT-199 and obinutuzumab. [This is] a very exciting combination.”
Other novel-novel agent combinations are also being looked at, he noted.
In CLL patients without 17p deletions who progress later than 2 years after initial chemotherapy, novel agents can be considered, as could alternative approaches with chemotherapy.
“But of course, in the setting of p53 deletions or mutations, then ibrutinib or idelalisib/rituximab, or novel agents like ABT-199 within clinical trials become the treatment approach to be thinking about,” he said.
CHICAGO – Consider using novel agents in chronic lymphocytic leukemia (CLL) patients who are refractory to treatment or who relapse within 2 years of first-line therapy, Dr. John G. Gribben said.
Ibrutinib or idelalisib/rituximab, or other novel agent combinations within clinical trials are his choice in these patients, thus fitness for therapy becomes irrelevant, he said at the American Society of Hematology Meeting on Hematologic Malignancies.
“Of course, I’m particularly excited by the results in CLL of ABT-199. We saw at [the International Workshop on CLL] last week that there are increasing numbers of patients who are on this therapy in combination with anti-CD20 monoclonal antibodies who are achieving minimal residual disease (MRD) eradication and are able to stop that therapy, unlike what we’ve been seeing,” he said. “I have a patient at my own center now who was treated with ABT-199 plus obinutuzumab within a clinical trial – a 17p deletion patient refractory to seven previous lines of therapy. Had a donor, I was trying to get him to transplant, and now he’s MRD-negative and off therapy, having had 6 months of therapy with ABT-199 and obinutuzumab. [This is] a very exciting combination.”
Other novel-novel agent combinations are also being looked at, he noted.
In CLL patients without 17p deletions who progress later than 2 years after initial chemotherapy, novel agents can be considered, as could alternative approaches with chemotherapy.
“But of course, in the setting of p53 deletions or mutations, then ibrutinib or idelalisib/rituximab, or novel agents like ABT-199 within clinical trials become the treatment approach to be thinking about,” he said.
EXPERT ANALYSIS FROM MHM 2015
Chromosome 3 abnormalities linked to poor CML outcomes
Chromosome 3 abnormalities, specifically 3q26.2 rearrangements, were associated with treatment resistance and poor prognosis in patients with chronic myelogenous leukemia (CML), report Dr. Wei Wang and coauthors of the department of hematopathology at the University of Texas MD Anderson Cancer Center in Houston.
A study of 2,013 CML patients found that just 6% of those with 3q26.2 abnormalities achieved complete cytogenetic response during the course of tyrosine kinase inhibitor (TKI) treatment. Patients with other chromosome 3 abnormalities had a significantly better response rate of 42% the investigators found.
Additionally, patients with 3q26.2 chromosome rearrangements had significantly worse survival rates than those with abnormalities involving other chromosomes, with 2-year overall survival rates of 22% and 60%, respectively.
The lack of response to TKI treatment “raises the issue of how to manage these patients,” Dr. Wang and associates said in the report.
“TKIs themselves are not sufficient to control the disease with 3q26.2 abnormalities,” they added. “Intensive therapy, stem cell transplantation, or investigational therapy targeted to EVI1 should be considered,” concluded the authors, who declared that they had no competing financial interests.
Read the full article in Blood.
Chromosome 3 abnormalities, specifically 3q26.2 rearrangements, were associated with treatment resistance and poor prognosis in patients with chronic myelogenous leukemia (CML), report Dr. Wei Wang and coauthors of the department of hematopathology at the University of Texas MD Anderson Cancer Center in Houston.
A study of 2,013 CML patients found that just 6% of those with 3q26.2 abnormalities achieved complete cytogenetic response during the course of tyrosine kinase inhibitor (TKI) treatment. Patients with other chromosome 3 abnormalities had a significantly better response rate of 42% the investigators found.
Additionally, patients with 3q26.2 chromosome rearrangements had significantly worse survival rates than those with abnormalities involving other chromosomes, with 2-year overall survival rates of 22% and 60%, respectively.
The lack of response to TKI treatment “raises the issue of how to manage these patients,” Dr. Wang and associates said in the report.
“TKIs themselves are not sufficient to control the disease with 3q26.2 abnormalities,” they added. “Intensive therapy, stem cell transplantation, or investigational therapy targeted to EVI1 should be considered,” concluded the authors, who declared that they had no competing financial interests.
Read the full article in Blood.
Chromosome 3 abnormalities, specifically 3q26.2 rearrangements, were associated with treatment resistance and poor prognosis in patients with chronic myelogenous leukemia (CML), report Dr. Wei Wang and coauthors of the department of hematopathology at the University of Texas MD Anderson Cancer Center in Houston.
A study of 2,013 CML patients found that just 6% of those with 3q26.2 abnormalities achieved complete cytogenetic response during the course of tyrosine kinase inhibitor (TKI) treatment. Patients with other chromosome 3 abnormalities had a significantly better response rate of 42% the investigators found.
Additionally, patients with 3q26.2 chromosome rearrangements had significantly worse survival rates than those with abnormalities involving other chromosomes, with 2-year overall survival rates of 22% and 60%, respectively.
The lack of response to TKI treatment “raises the issue of how to manage these patients,” Dr. Wang and associates said in the report.
“TKIs themselves are not sufficient to control the disease with 3q26.2 abnormalities,” they added. “Intensive therapy, stem cell transplantation, or investigational therapy targeted to EVI1 should be considered,” concluded the authors, who declared that they had no competing financial interests.
Read the full article in Blood.
Chromosome 3 abnormalities linked to poor CML outcomes
Chromosome 3 abnormalities, specifically 3q26.2 rearrangements, were associated with treatment resistance and poor prognosis in patients with chronic myelogenous leukemia (CML), report Dr. Wei Wang and coauthors of the department of hematopathology at the University of Texas MD Anderson Cancer Center in Houston.
A study of 2,013 CML patients found that just 6% of those with 3q26.2 abnormalities achieved complete cytogenetic response during the course of tyrosine kinase inhibitor (TKI) treatment. Patients with other chromosome 3 abnormalities had a significantly better response rate of 42% the investigators found.
Additionally, patients with 3q26.2 chromosome rearrangements had significantly worse survival rates than those with abnormalities involving other chromosomes, with 2-year overall survival rates of 22% and 60%, respectively.
The lack of response to TKI treatment “raises the issue of how to manage these patients,” Dr. Wang and associates said in the report.
“TKIs themselves are not sufficient to control the disease with 3q26.2 abnormalities,” they added. “Intensive therapy, stem cell transplantation, or investigational therapy targeted to EVI1 should be considered,” concluded the authors, who declared that they had no competing financial interests.
Read the full article in Blood.
Chromosome 3 abnormalities, specifically 3q26.2 rearrangements, were associated with treatment resistance and poor prognosis in patients with chronic myelogenous leukemia (CML), report Dr. Wei Wang and coauthors of the department of hematopathology at the University of Texas MD Anderson Cancer Center in Houston.
A study of 2,013 CML patients found that just 6% of those with 3q26.2 abnormalities achieved complete cytogenetic response during the course of tyrosine kinase inhibitor (TKI) treatment. Patients with other chromosome 3 abnormalities had a significantly better response rate of 42% the investigators found.
Additionally, patients with 3q26.2 chromosome rearrangements had significantly worse survival rates than those with abnormalities involving other chromosomes, with 2-year overall survival rates of 22% and 60%, respectively.
The lack of response to TKI treatment “raises the issue of how to manage these patients,” Dr. Wang and associates said in the report.
“TKIs themselves are not sufficient to control the disease with 3q26.2 abnormalities,” they added. “Intensive therapy, stem cell transplantation, or investigational therapy targeted to EVI1 should be considered,” concluded the authors, who declared that they had no competing financial interests.
Read the full article in Blood.
Chromosome 3 abnormalities, specifically 3q26.2 rearrangements, were associated with treatment resistance and poor prognosis in patients with chronic myelogenous leukemia (CML), report Dr. Wei Wang and coauthors of the department of hematopathology at the University of Texas MD Anderson Cancer Center in Houston.
A study of 2,013 CML patients found that just 6% of those with 3q26.2 abnormalities achieved complete cytogenetic response during the course of tyrosine kinase inhibitor (TKI) treatment. Patients with other chromosome 3 abnormalities had a significantly better response rate of 42% the investigators found.
Additionally, patients with 3q26.2 chromosome rearrangements had significantly worse survival rates than those with abnormalities involving other chromosomes, with 2-year overall survival rates of 22% and 60%, respectively.
The lack of response to TKI treatment “raises the issue of how to manage these patients,” Dr. Wang and associates said in the report.
“TKIs themselves are not sufficient to control the disease with 3q26.2 abnormalities,” they added. “Intensive therapy, stem cell transplantation, or investigational therapy targeted to EVI1 should be considered,” concluded the authors, who declared that they had no competing financial interests.
Read the full article in Blood.
Dear insurance companies: Stop sending me unnecessary reminder letters
I am, apparently, not a very good doctor. At least, that’s what some mailings I get from insurance companies make me think.
You probably get the same ones. They tell me what guidelines I’m not following or drug interactions I’m not mindful of. I suppose I should be grateful for their efforts to protect patients.
Letters I’ve gotten in the last week have reminded me that:
• Patients with elevated fasting blood sugars should be started on metformin.
• A lady on Eliquis (apixaban) after developing a deep-vein thrombosis should be considered for a less costly alternative, such as warfarin, to help her save money.
• An antihypertensive agent is recommended for a young man with persistently elevated blood pressures.
• An older gentleman’s lipid-lowering agent may interfere with his diabetes medication.
What do these have to do with anything that I, as a neurologist, am doing for the patient? Nothing.
Why are they being sent to me, as opposed to an internist or cardiologist? I have no idea. Of course, for all I know, the other docs might be getting recommendations on how to manage Parkinson’s disease or multiple sclerosis.
The insurance companies pay the bills. They obviously know which doctors are seeing who and prescribing what. Their billing systems track who practices what specialty. If I were to try submitting a claim for pulmonary evaluation, I’m sure they’d immediately notice and deny it.
So why can’t they get this straight? It seems like a big waste of time, paper, and postage all around.
On rare occasions, they actually get it right … sort of. About a month ago, I received a letter about a migraine patient, telling me that, for those with frequent migraines, a preventive medication should be considered. It even listed her current prescriptions to help me understand.
I absolutely agree with the letter, but it completely ignored that her medication list already included topiramate and nortriptyline, both commonly used for migraine prophylaxis. Since she has no other reason to be on either, I have no idea why they thought I’d use them. These kinds of notes all end with some generic comment that these are just suggestions, and only I and my patient can make the correct decisions about treatment, etc. etc.
That letter may be well intentioned, perhaps, but it is also inaccurate, unnecessary, and – to me – even a little demeaning. If you don’t think I know what I’m doing, then why are you sending patients to me? Maybe the software you’re using to screen charts and send these letters should open its own practice instead.
If the real goal of these letters is to save money (and we all know it is), then why is the company wasting it on redundant and inaccurate letters, usually not even sent to the correct doctor?
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I am, apparently, not a very good doctor. At least, that’s what some mailings I get from insurance companies make me think.
You probably get the same ones. They tell me what guidelines I’m not following or drug interactions I’m not mindful of. I suppose I should be grateful for their efforts to protect patients.
Letters I’ve gotten in the last week have reminded me that:
• Patients with elevated fasting blood sugars should be started on metformin.
• A lady on Eliquis (apixaban) after developing a deep-vein thrombosis should be considered for a less costly alternative, such as warfarin, to help her save money.
• An antihypertensive agent is recommended for a young man with persistently elevated blood pressures.
• An older gentleman’s lipid-lowering agent may interfere with his diabetes medication.
What do these have to do with anything that I, as a neurologist, am doing for the patient? Nothing.
Why are they being sent to me, as opposed to an internist or cardiologist? I have no idea. Of course, for all I know, the other docs might be getting recommendations on how to manage Parkinson’s disease or multiple sclerosis.
The insurance companies pay the bills. They obviously know which doctors are seeing who and prescribing what. Their billing systems track who practices what specialty. If I were to try submitting a claim for pulmonary evaluation, I’m sure they’d immediately notice and deny it.
So why can’t they get this straight? It seems like a big waste of time, paper, and postage all around.
On rare occasions, they actually get it right … sort of. About a month ago, I received a letter about a migraine patient, telling me that, for those with frequent migraines, a preventive medication should be considered. It even listed her current prescriptions to help me understand.
I absolutely agree with the letter, but it completely ignored that her medication list already included topiramate and nortriptyline, both commonly used for migraine prophylaxis. Since she has no other reason to be on either, I have no idea why they thought I’d use them. These kinds of notes all end with some generic comment that these are just suggestions, and only I and my patient can make the correct decisions about treatment, etc. etc.
That letter may be well intentioned, perhaps, but it is also inaccurate, unnecessary, and – to me – even a little demeaning. If you don’t think I know what I’m doing, then why are you sending patients to me? Maybe the software you’re using to screen charts and send these letters should open its own practice instead.
If the real goal of these letters is to save money (and we all know it is), then why is the company wasting it on redundant and inaccurate letters, usually not even sent to the correct doctor?
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I am, apparently, not a very good doctor. At least, that’s what some mailings I get from insurance companies make me think.
You probably get the same ones. They tell me what guidelines I’m not following or drug interactions I’m not mindful of. I suppose I should be grateful for their efforts to protect patients.
Letters I’ve gotten in the last week have reminded me that:
• Patients with elevated fasting blood sugars should be started on metformin.
• A lady on Eliquis (apixaban) after developing a deep-vein thrombosis should be considered for a less costly alternative, such as warfarin, to help her save money.
• An antihypertensive agent is recommended for a young man with persistently elevated blood pressures.
• An older gentleman’s lipid-lowering agent may interfere with his diabetes medication.
What do these have to do with anything that I, as a neurologist, am doing for the patient? Nothing.
Why are they being sent to me, as opposed to an internist or cardiologist? I have no idea. Of course, for all I know, the other docs might be getting recommendations on how to manage Parkinson’s disease or multiple sclerosis.
The insurance companies pay the bills. They obviously know which doctors are seeing who and prescribing what. Their billing systems track who practices what specialty. If I were to try submitting a claim for pulmonary evaluation, I’m sure they’d immediately notice and deny it.
So why can’t they get this straight? It seems like a big waste of time, paper, and postage all around.
On rare occasions, they actually get it right … sort of. About a month ago, I received a letter about a migraine patient, telling me that, for those with frequent migraines, a preventive medication should be considered. It even listed her current prescriptions to help me understand.
I absolutely agree with the letter, but it completely ignored that her medication list already included topiramate and nortriptyline, both commonly used for migraine prophylaxis. Since she has no other reason to be on either, I have no idea why they thought I’d use them. These kinds of notes all end with some generic comment that these are just suggestions, and only I and my patient can make the correct decisions about treatment, etc. etc.
That letter may be well intentioned, perhaps, but it is also inaccurate, unnecessary, and – to me – even a little demeaning. If you don’t think I know what I’m doing, then why are you sending patients to me? Maybe the software you’re using to screen charts and send these letters should open its own practice instead.
If the real goal of these letters is to save money (and we all know it is), then why is the company wasting it on redundant and inaccurate letters, usually not even sent to the correct doctor?
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Dear insurance companies: Stop sending me unnecessary reminder letters
I am, apparently, not a very good doctor. At least, that’s what some mailings I get from insurance companies make me think.
You probably get the same ones. They tell me what guidelines I’m not following or drug interactions I’m not mindful of. I suppose I should be grateful for their efforts to protect patients.
Letters I’ve gotten in the last week have reminded me that:
• Patients with elevated fasting blood sugars should be started on metformin.
• A lady on Eliquis (apixaban) after developing a deep-vein thrombosis should be considered for a less costly alternative, such as warfarin, to help her save money.
• An antihypertensive agent is recommended for a young man with persistently elevated blood pressures.
• An older gentleman’s lipid-lowering agent may interfere with his diabetes medication.
What do these have to do with anything that I, as a neurologist, am doing for the patient? Nothing.
Why are they being sent to me, as opposed to an internist or cardiologist? I have no idea. Of course, for all I know, the other docs might be getting recommendations on how to manage Parkinson’s disease or multiple sclerosis.
The insurance companies pay the bills. They obviously know which doctors are seeing who and prescribing what. Their billing systems track who practices what specialty. If I were to try submitting a claim for pulmonary evaluation, I’m sure they’d immediately notice and deny it.
So why can’t they get this straight? It seems like a big waste of time, paper, and postage all around.
On rare occasions, they actually get it right … sort of. About a month ago, I received a letter about a migraine patient, telling me that, for those with frequent migraines, a preventive medication should be considered. It even listed her current prescriptions to help me understand.
I absolutely agree with the letter, but it completely ignored that her medication list already included topiramate and nortriptyline, both commonly used for migraine prophylaxis. Since she has no other reason to be on either, I have no idea why they thought I’d use them. These kinds of notes all end with some generic comment that these are just suggestions, and only I and my patient can make the correct decisions about treatment, etc. etc.
That letter may be well intentioned, perhaps, but it is also inaccurate, unnecessary, and – to me – even a little demeaning. If you don’t think I know what I’m doing, then why are you sending patients to me? Maybe the software you’re using to screen charts and send these letters should open its own practice instead.
If the real goal of these letters is to save money (and we all know it is), then why is the company wasting it on redundant and inaccurate letters, usually not even sent to the correct doctor?
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I am, apparently, not a very good doctor. At least, that’s what some mailings I get from insurance companies make me think.
You probably get the same ones. They tell me what guidelines I’m not following or drug interactions I’m not mindful of. I suppose I should be grateful for their efforts to protect patients.
Letters I’ve gotten in the last week have reminded me that:
• Patients with elevated fasting blood sugars should be started on metformin.
• A lady on Eliquis (apixaban) after developing a deep-vein thrombosis should be considered for a less costly alternative, such as warfarin, to help her save money.
• An antihypertensive agent is recommended for a young man with persistently elevated blood pressures.
• An older gentleman’s lipid-lowering agent may interfere with his diabetes medication.
What do these have to do with anything that I, as a neurologist, am doing for the patient? Nothing.
Why are they being sent to me, as opposed to an internist or cardiologist? I have no idea. Of course, for all I know, the other docs might be getting recommendations on how to manage Parkinson’s disease or multiple sclerosis.
The insurance companies pay the bills. They obviously know which doctors are seeing who and prescribing what. Their billing systems track who practices what specialty. If I were to try submitting a claim for pulmonary evaluation, I’m sure they’d immediately notice and deny it.
So why can’t they get this straight? It seems like a big waste of time, paper, and postage all around.
On rare occasions, they actually get it right … sort of. About a month ago, I received a letter about a migraine patient, telling me that, for those with frequent migraines, a preventive medication should be considered. It even listed her current prescriptions to help me understand.
I absolutely agree with the letter, but it completely ignored that her medication list already included topiramate and nortriptyline, both commonly used for migraine prophylaxis. Since she has no other reason to be on either, I have no idea why they thought I’d use them. These kinds of notes all end with some generic comment that these are just suggestions, and only I and my patient can make the correct decisions about treatment, etc. etc.
That letter may be well intentioned, perhaps, but it is also inaccurate, unnecessary, and – to me – even a little demeaning. If you don’t think I know what I’m doing, then why are you sending patients to me? Maybe the software you’re using to screen charts and send these letters should open its own practice instead.
If the real goal of these letters is to save money (and we all know it is), then why is the company wasting it on redundant and inaccurate letters, usually not even sent to the correct doctor?
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I am, apparently, not a very good doctor. At least, that’s what some mailings I get from insurance companies make me think.
You probably get the same ones. They tell me what guidelines I’m not following or drug interactions I’m not mindful of. I suppose I should be grateful for their efforts to protect patients.
Letters I’ve gotten in the last week have reminded me that:
• Patients with elevated fasting blood sugars should be started on metformin.
• A lady on Eliquis (apixaban) after developing a deep-vein thrombosis should be considered for a less costly alternative, such as warfarin, to help her save money.
• An antihypertensive agent is recommended for a young man with persistently elevated blood pressures.
• An older gentleman’s lipid-lowering agent may interfere with his diabetes medication.
What do these have to do with anything that I, as a neurologist, am doing for the patient? Nothing.
Why are they being sent to me, as opposed to an internist or cardiologist? I have no idea. Of course, for all I know, the other docs might be getting recommendations on how to manage Parkinson’s disease or multiple sclerosis.
The insurance companies pay the bills. They obviously know which doctors are seeing who and prescribing what. Their billing systems track who practices what specialty. If I were to try submitting a claim for pulmonary evaluation, I’m sure they’d immediately notice and deny it.
So why can’t they get this straight? It seems like a big waste of time, paper, and postage all around.
On rare occasions, they actually get it right … sort of. About a month ago, I received a letter about a migraine patient, telling me that, for those with frequent migraines, a preventive medication should be considered. It even listed her current prescriptions to help me understand.
I absolutely agree with the letter, but it completely ignored that her medication list already included topiramate and nortriptyline, both commonly used for migraine prophylaxis. Since she has no other reason to be on either, I have no idea why they thought I’d use them. These kinds of notes all end with some generic comment that these are just suggestions, and only I and my patient can make the correct decisions about treatment, etc. etc.
That letter may be well intentioned, perhaps, but it is also inaccurate, unnecessary, and – to me – even a little demeaning. If you don’t think I know what I’m doing, then why are you sending patients to me? Maybe the software you’re using to screen charts and send these letters should open its own practice instead.
If the real goal of these letters is to save money (and we all know it is), then why is the company wasting it on redundant and inaccurate letters, usually not even sent to the correct doctor?
Dr. Block has a solo neurology practice in Scottsdale, Ariz.