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FDA gives breakthrough status to midostaurin for AML
An experimental treatment targeting a form of acute myeloid leukemia has been designated a breakthrough therapy by the Food and Drug Administration, according to the drug’s manufacturer.
Midostaurin (Novartis) is an oral drug used alongside standard chemotherapy for adults with newly-diagnosed AML who are positive for the FMS-like tyrosine 3 (FLT-3) mutation and can undergo chemotherapy. AML has the lowest survival rate of all leukemias, and about one-third of AML patients have the FLT-3 mutation.
The FDA’s breakthrough therapy designation, in place since 2012, is an intensive form of fast-tracking in which the agency offers the manufacturer more guidance on an efficient drug development program and a higher level of organizational support, though future approval is not guaranteed. To qualify, a therapy must come with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint over available therapy, according to the agency.
Results from a phase III clinical trial, presented in December 2015 at the 57th annual meeting of the American Society of Hematology, showed that among 717 patients randomized to receive midostaurin alongside standard induction and consolidation chemotherapy or the same chemotherapy protocol alone, the midostaurin group saw significant improvement in overall survival (hazard ratio, 0.77, P = .0074).
Mean OS for patients in the midostaurin arm was 74.7 months (95% CI: 31.7, not attained), compared with 25.6 months for the placebo arm (18.6, 42.9). Median follow-up in the study was 57 months for surviving patients.
In a news release Feb. 19, Novartis said that midostaurin would be submitted for FDA approval for FLT-3-positive AML and that the company had launched compassionate use and expanded access programs allowing newly diagnosed patients aged 18 and older to receive midostaurin alongside standard induction and consolidation therapy. No targeted AML treatments are currently approved by FDA.
FLT3 is a receptor tyrosine kinase that plays a role in the proliferation in the number of certain blood cells. Midostaurin is a multi-targeted kinase inhibitor that is also being investigated for the treatment of aggressive systemic mast cell leukemia, according to Novartis.
An experimental treatment targeting a form of acute myeloid leukemia has been designated a breakthrough therapy by the Food and Drug Administration, according to the drug’s manufacturer.
Midostaurin (Novartis) is an oral drug used alongside standard chemotherapy for adults with newly-diagnosed AML who are positive for the FMS-like tyrosine 3 (FLT-3) mutation and can undergo chemotherapy. AML has the lowest survival rate of all leukemias, and about one-third of AML patients have the FLT-3 mutation.
The FDA’s breakthrough therapy designation, in place since 2012, is an intensive form of fast-tracking in which the agency offers the manufacturer more guidance on an efficient drug development program and a higher level of organizational support, though future approval is not guaranteed. To qualify, a therapy must come with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint over available therapy, according to the agency.
Results from a phase III clinical trial, presented in December 2015 at the 57th annual meeting of the American Society of Hematology, showed that among 717 patients randomized to receive midostaurin alongside standard induction and consolidation chemotherapy or the same chemotherapy protocol alone, the midostaurin group saw significant improvement in overall survival (hazard ratio, 0.77, P = .0074).
Mean OS for patients in the midostaurin arm was 74.7 months (95% CI: 31.7, not attained), compared with 25.6 months for the placebo arm (18.6, 42.9). Median follow-up in the study was 57 months for surviving patients.
In a news release Feb. 19, Novartis said that midostaurin would be submitted for FDA approval for FLT-3-positive AML and that the company had launched compassionate use and expanded access programs allowing newly diagnosed patients aged 18 and older to receive midostaurin alongside standard induction and consolidation therapy. No targeted AML treatments are currently approved by FDA.
FLT3 is a receptor tyrosine kinase that plays a role in the proliferation in the number of certain blood cells. Midostaurin is a multi-targeted kinase inhibitor that is also being investigated for the treatment of aggressive systemic mast cell leukemia, according to Novartis.
An experimental treatment targeting a form of acute myeloid leukemia has been designated a breakthrough therapy by the Food and Drug Administration, according to the drug’s manufacturer.
Midostaurin (Novartis) is an oral drug used alongside standard chemotherapy for adults with newly-diagnosed AML who are positive for the FMS-like tyrosine 3 (FLT-3) mutation and can undergo chemotherapy. AML has the lowest survival rate of all leukemias, and about one-third of AML patients have the FLT-3 mutation.
The FDA’s breakthrough therapy designation, in place since 2012, is an intensive form of fast-tracking in which the agency offers the manufacturer more guidance on an efficient drug development program and a higher level of organizational support, though future approval is not guaranteed. To qualify, a therapy must come with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint over available therapy, according to the agency.
Results from a phase III clinical trial, presented in December 2015 at the 57th annual meeting of the American Society of Hematology, showed that among 717 patients randomized to receive midostaurin alongside standard induction and consolidation chemotherapy or the same chemotherapy protocol alone, the midostaurin group saw significant improvement in overall survival (hazard ratio, 0.77, P = .0074).
Mean OS for patients in the midostaurin arm was 74.7 months (95% CI: 31.7, not attained), compared with 25.6 months for the placebo arm (18.6, 42.9). Median follow-up in the study was 57 months for surviving patients.
In a news release Feb. 19, Novartis said that midostaurin would be submitted for FDA approval for FLT-3-positive AML and that the company had launched compassionate use and expanded access programs allowing newly diagnosed patients aged 18 and older to receive midostaurin alongside standard induction and consolidation therapy. No targeted AML treatments are currently approved by FDA.
FLT3 is a receptor tyrosine kinase that plays a role in the proliferation in the number of certain blood cells. Midostaurin is a multi-targeted kinase inhibitor that is also being investigated for the treatment of aggressive systemic mast cell leukemia, according to Novartis.
Zika virus found in amniotic fluid
A case study conducted in Brazil revealed the presence of Zika virus in the amniotic fluid of two pregnant women, suggesting that the virus can cross the placental barrier and potentially infect the developing fetus.
Both women in the study had their amniotic fluid samples taken at 28 weeks, and later gave birth to babies with microcephaly.
The finding, published online Feb 17 in The Lancet Infectious Diseases (Lancet Infect Dis. 2016 Feb 17. doi: 10.1016/S1473-3099[16]00095-5), does not prove that Zika virus infection causes microcephaly but does suggest the biological plausibility of such a link.
In the same study, the researchers, led by Dr. Ana de Filippis of Oswaldo Cruz Institute in Rio de Janeiro, applied reverse transcription polymerase chain reaction and viral metagenomic sequencing to the viral samples, allowing them to establish that the virus was very closely related to the Zika virus that caused an outbreak in French Polynesia in 2013, and was not a recombinant strain.
The women in the study, age 27 and 35, were from the Brazilian state of Paraíba. Neither woman reported smoking, using recreational drugs or alcohol, or taking medications known to affect fetal development.
Zika virus was not found in the blood or urine of either woman when the amniotic samples were taken, though both had reported earlier symptoms consistent with Zika infection. Other infections, including HIV, dengue, chikungunya, rubella, and herpes viruses, were ruled out.
The results provide important insight into the origin of the Zika virus circulating in Brazil, the researchers wrote in their analysis. Moreover, “our group is the first, to our knowledge, to isolate the whole genome of Zika virus directly from the amniotic fluid of a pregnant woman before delivery, supporting the hypothesis that Zika virus infection could occur through transplacental transmission,” wrote Dr. de Filippis and her colleagues.
Still, little is known about the effects of Zika on the developing central nervous system, the researchers wrote. A connection between Zika virus infections and poor CNS outcomes “remains presumptive, and is based on a temporal association. New studies should be done to investigate whether the Zika virus can infect either neurological precursor cells or final differentiated cells.”
The researchers cautioned that congenital microcephaly has been associated with genetic disorders, chemical exposures, brain injury and uterine infections. Other possible contributors to the current high rate of microcephaly in Brazil, which last year was 20 times higher than in previous years, need to be investigated, they wrote.
Agencies within Brazil’s national government and the city of Rio de Janeiro funded the study, and investigators disclosed no conflicts of interest.
The temporal association between Zika virus outbreaks and microcephaly in Brazil strongly suggests that Zika virus infection during pregnancy might cause severe neurological damage in neonates. The challenge now is to provide empirical evidence for the link between Zika virus and microcephaly, and the demonstration that Zika virus can cross the placental barrier and infect the neonate strongly favors this association.
Even if all these data strongly suggest that Zika virus can cause microcephaly, the number of microcephaly cases related to Zika virus is still unknown. The next step will be to do case-control studies to estimate the potential risk of microcephaly after Zika virus infection during pregnancy, other fetal or neonatal complications, and long-term outcomes for infected symptomatic and asymptomatic neonates.
These comments were adapted from commentary by Dr. Didier Musso, Institut Louis Malardé, Tahiti, French Polynesia, and Dr. David Baud, University of Lausanne and University Hospital, Lausanne, Switzerland (Lancet Infect Dis. 2016 Feb 17. doi: 10.1016/S1473-3099[16]0096-7). Dr. Musso and Dr. Baud reported no conflicts of interest.
The temporal association between Zika virus outbreaks and microcephaly in Brazil strongly suggests that Zika virus infection during pregnancy might cause severe neurological damage in neonates. The challenge now is to provide empirical evidence for the link between Zika virus and microcephaly, and the demonstration that Zika virus can cross the placental barrier and infect the neonate strongly favors this association.
Even if all these data strongly suggest that Zika virus can cause microcephaly, the number of microcephaly cases related to Zika virus is still unknown. The next step will be to do case-control studies to estimate the potential risk of microcephaly after Zika virus infection during pregnancy, other fetal or neonatal complications, and long-term outcomes for infected symptomatic and asymptomatic neonates.
These comments were adapted from commentary by Dr. Didier Musso, Institut Louis Malardé, Tahiti, French Polynesia, and Dr. David Baud, University of Lausanne and University Hospital, Lausanne, Switzerland (Lancet Infect Dis. 2016 Feb 17. doi: 10.1016/S1473-3099[16]0096-7). Dr. Musso and Dr. Baud reported no conflicts of interest.
The temporal association between Zika virus outbreaks and microcephaly in Brazil strongly suggests that Zika virus infection during pregnancy might cause severe neurological damage in neonates. The challenge now is to provide empirical evidence for the link between Zika virus and microcephaly, and the demonstration that Zika virus can cross the placental barrier and infect the neonate strongly favors this association.
Even if all these data strongly suggest that Zika virus can cause microcephaly, the number of microcephaly cases related to Zika virus is still unknown. The next step will be to do case-control studies to estimate the potential risk of microcephaly after Zika virus infection during pregnancy, other fetal or neonatal complications, and long-term outcomes for infected symptomatic and asymptomatic neonates.
These comments were adapted from commentary by Dr. Didier Musso, Institut Louis Malardé, Tahiti, French Polynesia, and Dr. David Baud, University of Lausanne and University Hospital, Lausanne, Switzerland (Lancet Infect Dis. 2016 Feb 17. doi: 10.1016/S1473-3099[16]0096-7). Dr. Musso and Dr. Baud reported no conflicts of interest.
A case study conducted in Brazil revealed the presence of Zika virus in the amniotic fluid of two pregnant women, suggesting that the virus can cross the placental barrier and potentially infect the developing fetus.
Both women in the study had their amniotic fluid samples taken at 28 weeks, and later gave birth to babies with microcephaly.
The finding, published online Feb 17 in The Lancet Infectious Diseases (Lancet Infect Dis. 2016 Feb 17. doi: 10.1016/S1473-3099[16]00095-5), does not prove that Zika virus infection causes microcephaly but does suggest the biological plausibility of such a link.
In the same study, the researchers, led by Dr. Ana de Filippis of Oswaldo Cruz Institute in Rio de Janeiro, applied reverse transcription polymerase chain reaction and viral metagenomic sequencing to the viral samples, allowing them to establish that the virus was very closely related to the Zika virus that caused an outbreak in French Polynesia in 2013, and was not a recombinant strain.
The women in the study, age 27 and 35, were from the Brazilian state of Paraíba. Neither woman reported smoking, using recreational drugs or alcohol, or taking medications known to affect fetal development.
Zika virus was not found in the blood or urine of either woman when the amniotic samples were taken, though both had reported earlier symptoms consistent with Zika infection. Other infections, including HIV, dengue, chikungunya, rubella, and herpes viruses, were ruled out.
The results provide important insight into the origin of the Zika virus circulating in Brazil, the researchers wrote in their analysis. Moreover, “our group is the first, to our knowledge, to isolate the whole genome of Zika virus directly from the amniotic fluid of a pregnant woman before delivery, supporting the hypothesis that Zika virus infection could occur through transplacental transmission,” wrote Dr. de Filippis and her colleagues.
Still, little is known about the effects of Zika on the developing central nervous system, the researchers wrote. A connection between Zika virus infections and poor CNS outcomes “remains presumptive, and is based on a temporal association. New studies should be done to investigate whether the Zika virus can infect either neurological precursor cells or final differentiated cells.”
The researchers cautioned that congenital microcephaly has been associated with genetic disorders, chemical exposures, brain injury and uterine infections. Other possible contributors to the current high rate of microcephaly in Brazil, which last year was 20 times higher than in previous years, need to be investigated, they wrote.
Agencies within Brazil’s national government and the city of Rio de Janeiro funded the study, and investigators disclosed no conflicts of interest.
A case study conducted in Brazil revealed the presence of Zika virus in the amniotic fluid of two pregnant women, suggesting that the virus can cross the placental barrier and potentially infect the developing fetus.
Both women in the study had their amniotic fluid samples taken at 28 weeks, and later gave birth to babies with microcephaly.
The finding, published online Feb 17 in The Lancet Infectious Diseases (Lancet Infect Dis. 2016 Feb 17. doi: 10.1016/S1473-3099[16]00095-5), does not prove that Zika virus infection causes microcephaly but does suggest the biological plausibility of such a link.
In the same study, the researchers, led by Dr. Ana de Filippis of Oswaldo Cruz Institute in Rio de Janeiro, applied reverse transcription polymerase chain reaction and viral metagenomic sequencing to the viral samples, allowing them to establish that the virus was very closely related to the Zika virus that caused an outbreak in French Polynesia in 2013, and was not a recombinant strain.
The women in the study, age 27 and 35, were from the Brazilian state of Paraíba. Neither woman reported smoking, using recreational drugs or alcohol, or taking medications known to affect fetal development.
Zika virus was not found in the blood or urine of either woman when the amniotic samples were taken, though both had reported earlier symptoms consistent with Zika infection. Other infections, including HIV, dengue, chikungunya, rubella, and herpes viruses, were ruled out.
The results provide important insight into the origin of the Zika virus circulating in Brazil, the researchers wrote in their analysis. Moreover, “our group is the first, to our knowledge, to isolate the whole genome of Zika virus directly from the amniotic fluid of a pregnant woman before delivery, supporting the hypothesis that Zika virus infection could occur through transplacental transmission,” wrote Dr. de Filippis and her colleagues.
Still, little is known about the effects of Zika on the developing central nervous system, the researchers wrote. A connection between Zika virus infections and poor CNS outcomes “remains presumptive, and is based on a temporal association. New studies should be done to investigate whether the Zika virus can infect either neurological precursor cells or final differentiated cells.”
The researchers cautioned that congenital microcephaly has been associated with genetic disorders, chemical exposures, brain injury and uterine infections. Other possible contributors to the current high rate of microcephaly in Brazil, which last year was 20 times higher than in previous years, need to be investigated, they wrote.
Agencies within Brazil’s national government and the city of Rio de Janeiro funded the study, and investigators disclosed no conflicts of interest.
FROM THE LANCET INFECTIOUS DISEASES
Key clinical point: Zika virus can cross the placental barrier in pregnant women and potentially infect a fetus.
Major finding: Genetic sequencing showed virus detected in amniotic fluid corresponded 97%-100% with the strain that caused a 2013 outbreak in French Polynesia.
Data source: A case study of two women in the same region of Brazil, using amniotic samples from 28 weeks’ gestation in which Zika virus was detected and sequenced.
Disclosures: Two government agencies in Brazil sponsored the study, and investigators disclosed no conflicts of interest.
Recent Active Asthma Raises AAA Rupture Risk
Patients aged 50 and older with recent active asthma are at elevated risk of abdominal aortic aneurysm and aneurysm rupture, according to new research.
A common inflammatory pathway between asthma and AAA, first observed nearly a decade ago in mice, is thought to be responsible.
The new findings, published online Feb. 11 in Arteriosclerosis, Thrombosis, and Vascular Biology (Arterioscler Thromb Vasc Biol. 2016. doi: 10.1161/ATVBAHA.115.306497) support the association in humans.
In a news release accompanying the findings, lead study author Guo-Ping Shi, D.Sc., of Brigham and Women’s Hospital and Harvard Medical School, Boston, said that the findings had clear clinical implications for older patients with a recent asthma diagnosis. Such patients, particularly older men, “should be checked for signs” of abdominal aortic aneurysm, Dr. Shi said.
For their research, Dr. Shi, along with colleagues at Zhengzhou (China) University, used data from a large Danish population-based cohort of nearly 16,000 patients (81% men) with AAA between 1996 and 2012, of which about 4,500 patients had rupture. They also looked at data from a comparison cohort of patients with and without AAA from a slightly larger population-based vascular screening trial of men in Denmark.
The investigators showed that hospital diagnosis of asthma within the previous year (n = 514) was associated with significantly higher risk of hospital admission with AAA rupture (n = 146) both before and after adjustment for AAA comorbidities (adjusted odds ratio 1.51-2.06). Higher risk of rupture also was seen for patients filling prescriptions for bronchodilators within the previous 3 months (aOR = 1.10-1.31), and for patients prescribed anti-asthma drugs (aOR OR = 1.09-1.48), which were seen as indicative of an outpatient asthma diagnosis.
“A hospital diagnosis of asthma or a recently filled prescription of an anti-asthmatic drug is associated with an increased risk of admission with rAAA compared with admission with intact AAA, both before and after adjusting for AAA comorbidities and relevant medications,” the researchers wrote in their analysis.
Moreover, “an asthma diagnosis or the use of bronchodilators or other anti-asthmatic drug prescriptions closer to the date of admission with AAA correlated directly with a higher risk of aortic rupture. The results remained robust after adjusting for a wide range of relevant possible confounders,” the researchers wrote.
In the cohort of patients from the vascular screening study, which included age-matched controls without AAA, asthma (measured by recent anti-asthmatic medication use) was seen associated with a significantly elevated risk of AAA before (OR = 1.45) and after adjustment for smoking (OR = 1.45) or other risk factors (OR = 1.46). This does not refer to rupture but just AAA.
Dr. Shi and colleagues noted that the AAA cohort lacked sufficient information on cigarette smoking, a known risk factor for AAA and AAA rupture, to preclude the possibility of confounding; however, the second all-male cohort did have extensive data on smoking, “and the risk of AAA among patients with asthma remained 45% higher than that of patients with nonasthma” even after adjustment.
The researchers hypothesized that an inflammatory response characterized by elevated immunoglobulin E may be the link between AAA pathogenesis and asthma, and that other allergic inflammatory diseases, including atopic dermatitis, allergic rhinitis, and some ocular allergic diseases, could potentially carry risks for AAA formation and rupture. Dr. Shi and colleagues previously investigated the IgE and aneurysm link in animal studies.
“The results have implications for the development of much needed advances in the prevention, screening criteria, and treatment of AAA, common conditions for which we currently lack sufficiently effective approaches,” the investigators wrote.
The Chinese, Danish, and U.S. governments sponsored the study. The investigators disclosed no conflicts of interest.
Patients aged 50 and older with recent active asthma are at elevated risk of abdominal aortic aneurysm and aneurysm rupture, according to new research.
A common inflammatory pathway between asthma and AAA, first observed nearly a decade ago in mice, is thought to be responsible.
The new findings, published online Feb. 11 in Arteriosclerosis, Thrombosis, and Vascular Biology (Arterioscler Thromb Vasc Biol. 2016. doi: 10.1161/ATVBAHA.115.306497) support the association in humans.
In a news release accompanying the findings, lead study author Guo-Ping Shi, D.Sc., of Brigham and Women’s Hospital and Harvard Medical School, Boston, said that the findings had clear clinical implications for older patients with a recent asthma diagnosis. Such patients, particularly older men, “should be checked for signs” of abdominal aortic aneurysm, Dr. Shi said.
For their research, Dr. Shi, along with colleagues at Zhengzhou (China) University, used data from a large Danish population-based cohort of nearly 16,000 patients (81% men) with AAA between 1996 and 2012, of which about 4,500 patients had rupture. They also looked at data from a comparison cohort of patients with and without AAA from a slightly larger population-based vascular screening trial of men in Denmark.
The investigators showed that hospital diagnosis of asthma within the previous year (n = 514) was associated with significantly higher risk of hospital admission with AAA rupture (n = 146) both before and after adjustment for AAA comorbidities (adjusted odds ratio 1.51-2.06). Higher risk of rupture also was seen for patients filling prescriptions for bronchodilators within the previous 3 months (aOR = 1.10-1.31), and for patients prescribed anti-asthma drugs (aOR OR = 1.09-1.48), which were seen as indicative of an outpatient asthma diagnosis.
“A hospital diagnosis of asthma or a recently filled prescription of an anti-asthmatic drug is associated with an increased risk of admission with rAAA compared with admission with intact AAA, both before and after adjusting for AAA comorbidities and relevant medications,” the researchers wrote in their analysis.
Moreover, “an asthma diagnosis or the use of bronchodilators or other anti-asthmatic drug prescriptions closer to the date of admission with AAA correlated directly with a higher risk of aortic rupture. The results remained robust after adjusting for a wide range of relevant possible confounders,” the researchers wrote.
In the cohort of patients from the vascular screening study, which included age-matched controls without AAA, asthma (measured by recent anti-asthmatic medication use) was seen associated with a significantly elevated risk of AAA before (OR = 1.45) and after adjustment for smoking (OR = 1.45) or other risk factors (OR = 1.46). This does not refer to rupture but just AAA.
Dr. Shi and colleagues noted that the AAA cohort lacked sufficient information on cigarette smoking, a known risk factor for AAA and AAA rupture, to preclude the possibility of confounding; however, the second all-male cohort did have extensive data on smoking, “and the risk of AAA among patients with asthma remained 45% higher than that of patients with nonasthma” even after adjustment.
The researchers hypothesized that an inflammatory response characterized by elevated immunoglobulin E may be the link between AAA pathogenesis and asthma, and that other allergic inflammatory diseases, including atopic dermatitis, allergic rhinitis, and some ocular allergic diseases, could potentially carry risks for AAA formation and rupture. Dr. Shi and colleagues previously investigated the IgE and aneurysm link in animal studies.
“The results have implications for the development of much needed advances in the prevention, screening criteria, and treatment of AAA, common conditions for which we currently lack sufficiently effective approaches,” the investigators wrote.
The Chinese, Danish, and U.S. governments sponsored the study. The investigators disclosed no conflicts of interest.
Patients aged 50 and older with recent active asthma are at elevated risk of abdominal aortic aneurysm and aneurysm rupture, according to new research.
A common inflammatory pathway between asthma and AAA, first observed nearly a decade ago in mice, is thought to be responsible.
The new findings, published online Feb. 11 in Arteriosclerosis, Thrombosis, and Vascular Biology (Arterioscler Thromb Vasc Biol. 2016. doi: 10.1161/ATVBAHA.115.306497) support the association in humans.
In a news release accompanying the findings, lead study author Guo-Ping Shi, D.Sc., of Brigham and Women’s Hospital and Harvard Medical School, Boston, said that the findings had clear clinical implications for older patients with a recent asthma diagnosis. Such patients, particularly older men, “should be checked for signs” of abdominal aortic aneurysm, Dr. Shi said.
For their research, Dr. Shi, along with colleagues at Zhengzhou (China) University, used data from a large Danish population-based cohort of nearly 16,000 patients (81% men) with AAA between 1996 and 2012, of which about 4,500 patients had rupture. They also looked at data from a comparison cohort of patients with and without AAA from a slightly larger population-based vascular screening trial of men in Denmark.
The investigators showed that hospital diagnosis of asthma within the previous year (n = 514) was associated with significantly higher risk of hospital admission with AAA rupture (n = 146) both before and after adjustment for AAA comorbidities (adjusted odds ratio 1.51-2.06). Higher risk of rupture also was seen for patients filling prescriptions for bronchodilators within the previous 3 months (aOR = 1.10-1.31), and for patients prescribed anti-asthma drugs (aOR OR = 1.09-1.48), which were seen as indicative of an outpatient asthma diagnosis.
“A hospital diagnosis of asthma or a recently filled prescription of an anti-asthmatic drug is associated with an increased risk of admission with rAAA compared with admission with intact AAA, both before and after adjusting for AAA comorbidities and relevant medications,” the researchers wrote in their analysis.
Moreover, “an asthma diagnosis or the use of bronchodilators or other anti-asthmatic drug prescriptions closer to the date of admission with AAA correlated directly with a higher risk of aortic rupture. The results remained robust after adjusting for a wide range of relevant possible confounders,” the researchers wrote.
In the cohort of patients from the vascular screening study, which included age-matched controls without AAA, asthma (measured by recent anti-asthmatic medication use) was seen associated with a significantly elevated risk of AAA before (OR = 1.45) and after adjustment for smoking (OR = 1.45) or other risk factors (OR = 1.46). This does not refer to rupture but just AAA.
Dr. Shi and colleagues noted that the AAA cohort lacked sufficient information on cigarette smoking, a known risk factor for AAA and AAA rupture, to preclude the possibility of confounding; however, the second all-male cohort did have extensive data on smoking, “and the risk of AAA among patients with asthma remained 45% higher than that of patients with nonasthma” even after adjustment.
The researchers hypothesized that an inflammatory response characterized by elevated immunoglobulin E may be the link between AAA pathogenesis and asthma, and that other allergic inflammatory diseases, including atopic dermatitis, allergic rhinitis, and some ocular allergic diseases, could potentially carry risks for AAA formation and rupture. Dr. Shi and colleagues previously investigated the IgE and aneurysm link in animal studies.
“The results have implications for the development of much needed advances in the prevention, screening criteria, and treatment of AAA, common conditions for which we currently lack sufficiently effective approaches,” the investigators wrote.
The Chinese, Danish, and U.S. governments sponsored the study. The investigators disclosed no conflicts of interest.
FROM ARTERIOSCLEROSIS, THROMBOSIS, AND VASCULAR BIOLOGY
Recent active asthma raises AAA rupture risk
Patients aged 50 and older with recent active asthma are at elevated risk of abdominal aortic aneurysm and aneurysm rupture, according to new research.
A common inflammatory pathway between asthma and AAA, first observed nearly a decade ago in mice, is thought to be responsible.
The new findings, published online Feb. 11 in Arteriosclerosis, Thrombosis, and Vascular Biology (Arterioscler Thromb Vasc Biol. 2016. doi: 10.1161/ATVBAHA.115.306497) support the association in humans.
In a news release accompanying the findings, lead study author Guo-Ping Shi, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, said that the findings had clear clinical implications for older patients with a recent asthma diagnosis. Such patients, particularly older men, “should be checked for signs” of abdominal aortic aneurysm, Dr. Shi said.*
For their research, Dr. Shi, along with colleagues at Zhengzhou (China) University, used data from a large Danish population-based cohort of nearly 16,000 patients (81% men) with AAA between 1996 and 2012, of which about 4,500 patients had rupture. They also looked at data from a comparison cohort of patients with and without AAA from a slightly larger population-based vascular screening trial of men in Denmark.
The investigators showed that hospital diagnosis of asthma within the previous year (n = 514) was associated with significantly higher risk of hospital admission with AAA rupture (n = 146) both before and after adjustment for AAA comorbidities (adjusted odds ratio 1.51-2.06). Higher risk of rupture also was seen for patients filling prescriptions for bronchodilators within the previous 3 months (aOR = 1.10-1.31), and for patients prescribed anti-asthma drugs (aOR OR = 1.09-1.48), which were seen as indicative of an outpatient asthma diagnosis.
“A hospital diagnosis of asthma or a recently filled prescription of an anti-asthmatic drug is associated with an increased risk of admission with rAAA compared with admission with intact AAA, both before and after adjusting for AAA comorbidities and relevant medications,” the researchers wrote in their analysis.
Moreover, “an asthma diagnosis or the use of bronchodilators or other anti-asthmatic drug prescriptions closer to the date of admission with AAA correlated directly with a higher risk of aortic rupture. The results remained robust after adjusting for a wide range of relevant possible confounders,” the researchers wrote.
In the cohort of patients from the vascular screening study, which included age-matched controls without AAA, asthma (measured by recent anti-asthmatic medication use) was seen associated with a significantly elevated risk of AAA before (OR = 1.45) and after adjustment for smoking (OR = 1.45) or other risk factors (OR = 1.46). This does not refer to rupture but just AAA.
Dr. Shi and colleagues noted that the AAA cohort lacked sufficient information on cigarette smoking, a known risk factor for AAA and AAA rupture, to preclude the possibility of confounding; however, the second all-male cohort did have extensive data on smoking, “and the risk of AAA among patients with asthma remained 45% higher than that of patients with nonasthma” even after adjustment.
The researchers hypothesized that an inflammatory response characterized by elevated immunoglobulin E may be the link between AAA pathogenesis and asthma, and that other allergic inflammatory diseases, including atopic dermatitis, allergic rhinitis, and some ocular allergic diseases, could potentially carry risks for AAA formation and rupture. Dr. Shi and colleagues previously investigated the IgE and aneurysm link in animal studies.
“The results have implications for the development of much needed advances in the prevention, screening criteria, and treatment of AAA, common conditions for which we currently lack sufficiently effective approaches,” the investigators wrote.
The Chinese, Danish, and U.S. governments sponsored the study. The investigators disclosed no conflicts of interest.
*CORRECTION 8/12/2020: Dr. Shi's credential was misstated in the original version on this article and has been corrected to ScD.
Patients aged 50 and older with recent active asthma are at elevated risk of abdominal aortic aneurysm and aneurysm rupture, according to new research.
A common inflammatory pathway between asthma and AAA, first observed nearly a decade ago in mice, is thought to be responsible.
The new findings, published online Feb. 11 in Arteriosclerosis, Thrombosis, and Vascular Biology (Arterioscler Thromb Vasc Biol. 2016. doi: 10.1161/ATVBAHA.115.306497) support the association in humans.
In a news release accompanying the findings, lead study author Guo-Ping Shi, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, said that the findings had clear clinical implications for older patients with a recent asthma diagnosis. Such patients, particularly older men, “should be checked for signs” of abdominal aortic aneurysm, Dr. Shi said.*
For their research, Dr. Shi, along with colleagues at Zhengzhou (China) University, used data from a large Danish population-based cohort of nearly 16,000 patients (81% men) with AAA between 1996 and 2012, of which about 4,500 patients had rupture. They also looked at data from a comparison cohort of patients with and without AAA from a slightly larger population-based vascular screening trial of men in Denmark.
The investigators showed that hospital diagnosis of asthma within the previous year (n = 514) was associated with significantly higher risk of hospital admission with AAA rupture (n = 146) both before and after adjustment for AAA comorbidities (adjusted odds ratio 1.51-2.06). Higher risk of rupture also was seen for patients filling prescriptions for bronchodilators within the previous 3 months (aOR = 1.10-1.31), and for patients prescribed anti-asthma drugs (aOR OR = 1.09-1.48), which were seen as indicative of an outpatient asthma diagnosis.
“A hospital diagnosis of asthma or a recently filled prescription of an anti-asthmatic drug is associated with an increased risk of admission with rAAA compared with admission with intact AAA, both before and after adjusting for AAA comorbidities and relevant medications,” the researchers wrote in their analysis.
Moreover, “an asthma diagnosis or the use of bronchodilators or other anti-asthmatic drug prescriptions closer to the date of admission with AAA correlated directly with a higher risk of aortic rupture. The results remained robust after adjusting for a wide range of relevant possible confounders,” the researchers wrote.
In the cohort of patients from the vascular screening study, which included age-matched controls without AAA, asthma (measured by recent anti-asthmatic medication use) was seen associated with a significantly elevated risk of AAA before (OR = 1.45) and after adjustment for smoking (OR = 1.45) or other risk factors (OR = 1.46). This does not refer to rupture but just AAA.
Dr. Shi and colleagues noted that the AAA cohort lacked sufficient information on cigarette smoking, a known risk factor for AAA and AAA rupture, to preclude the possibility of confounding; however, the second all-male cohort did have extensive data on smoking, “and the risk of AAA among patients with asthma remained 45% higher than that of patients with nonasthma” even after adjustment.
The researchers hypothesized that an inflammatory response characterized by elevated immunoglobulin E may be the link between AAA pathogenesis and asthma, and that other allergic inflammatory diseases, including atopic dermatitis, allergic rhinitis, and some ocular allergic diseases, could potentially carry risks for AAA formation and rupture. Dr. Shi and colleagues previously investigated the IgE and aneurysm link in animal studies.
“The results have implications for the development of much needed advances in the prevention, screening criteria, and treatment of AAA, common conditions for which we currently lack sufficiently effective approaches,” the investigators wrote.
The Chinese, Danish, and U.S. governments sponsored the study. The investigators disclosed no conflicts of interest.
*CORRECTION 8/12/2020: Dr. Shi's credential was misstated in the original version on this article and has been corrected to ScD.
Patients aged 50 and older with recent active asthma are at elevated risk of abdominal aortic aneurysm and aneurysm rupture, according to new research.
A common inflammatory pathway between asthma and AAA, first observed nearly a decade ago in mice, is thought to be responsible.
The new findings, published online Feb. 11 in Arteriosclerosis, Thrombosis, and Vascular Biology (Arterioscler Thromb Vasc Biol. 2016. doi: 10.1161/ATVBAHA.115.306497) support the association in humans.
In a news release accompanying the findings, lead study author Guo-Ping Shi, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, said that the findings had clear clinical implications for older patients with a recent asthma diagnosis. Such patients, particularly older men, “should be checked for signs” of abdominal aortic aneurysm, Dr. Shi said.*
For their research, Dr. Shi, along with colleagues at Zhengzhou (China) University, used data from a large Danish population-based cohort of nearly 16,000 patients (81% men) with AAA between 1996 and 2012, of which about 4,500 patients had rupture. They also looked at data from a comparison cohort of patients with and without AAA from a slightly larger population-based vascular screening trial of men in Denmark.
The investigators showed that hospital diagnosis of asthma within the previous year (n = 514) was associated with significantly higher risk of hospital admission with AAA rupture (n = 146) both before and after adjustment for AAA comorbidities (adjusted odds ratio 1.51-2.06). Higher risk of rupture also was seen for patients filling prescriptions for bronchodilators within the previous 3 months (aOR = 1.10-1.31), and for patients prescribed anti-asthma drugs (aOR OR = 1.09-1.48), which were seen as indicative of an outpatient asthma diagnosis.
“A hospital diagnosis of asthma or a recently filled prescription of an anti-asthmatic drug is associated with an increased risk of admission with rAAA compared with admission with intact AAA, both before and after adjusting for AAA comorbidities and relevant medications,” the researchers wrote in their analysis.
Moreover, “an asthma diagnosis or the use of bronchodilators or other anti-asthmatic drug prescriptions closer to the date of admission with AAA correlated directly with a higher risk of aortic rupture. The results remained robust after adjusting for a wide range of relevant possible confounders,” the researchers wrote.
In the cohort of patients from the vascular screening study, which included age-matched controls without AAA, asthma (measured by recent anti-asthmatic medication use) was seen associated with a significantly elevated risk of AAA before (OR = 1.45) and after adjustment for smoking (OR = 1.45) or other risk factors (OR = 1.46). This does not refer to rupture but just AAA.
Dr. Shi and colleagues noted that the AAA cohort lacked sufficient information on cigarette smoking, a known risk factor for AAA and AAA rupture, to preclude the possibility of confounding; however, the second all-male cohort did have extensive data on smoking, “and the risk of AAA among patients with asthma remained 45% higher than that of patients with nonasthma” even after adjustment.
The researchers hypothesized that an inflammatory response characterized by elevated immunoglobulin E may be the link between AAA pathogenesis and asthma, and that other allergic inflammatory diseases, including atopic dermatitis, allergic rhinitis, and some ocular allergic diseases, could potentially carry risks for AAA formation and rupture. Dr. Shi and colleagues previously investigated the IgE and aneurysm link in animal studies.
“The results have implications for the development of much needed advances in the prevention, screening criteria, and treatment of AAA, common conditions for which we currently lack sufficiently effective approaches,” the investigators wrote.
The Chinese, Danish, and U.S. governments sponsored the study. The investigators disclosed no conflicts of interest.
*CORRECTION 8/12/2020: Dr. Shi's credential was misstated in the original version on this article and has been corrected to ScD.
FROM ARTERIOSCLEROSIS, THROMBOSIS, AND VASCULAR BIOLOGY
Key clinical point: Older patients with a recent asthma diagnosis, particularly men, should be checked for abdominal aortic aneurysms.
Major finding: People over 50 with recent active asthma and abdominal aortic aneurysm saw a more than 50% greater risk of rupture compared with patients without asthma.
Data source: Two large cohorts from Denmark of AAA patients 50 and older (n = 15,942) and men 65 and older with and without AAA (n = 18,749), with information on asthma diagnosis and rupture.
Disclosures: The Chinese, Danish, and U.S. governments sponsored the study. The investigators disclosed no conflicts of interest.
Ocular symptoms accompany microcephaly in Brazilian newborns
In a sample of infants born with microcephaly and a presumed diagnosis of congenital Zika virus, about one-third were found to have vision-threatening eye abnormalities, according to researchers working in a Zika hot spot in Brazil.
The group, led by Dr. Bruno de Paula Freitas of the Hospital Geral Roberto Santos, in Salvador, Brazil, evaluated 29 infants with microcephaly born at a single hospital in December following suspected maternal infection with the mosquito-borne Zika virus. In a paper published online Feb 9., Dr. de Paula Freitas and his colleagues reported eye abnormalities in 10 of these children (34.5%) (JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2016.0267.).
Brazil first reported an outbreak of Zika virus infections in April 2015, followed months later by a spike in the number of infants born with microcephaly, a birth defect defined by a cephalic circumference of 32 cm or less in newborns. The most common ocular abnormalities seen in the cohort of affected infants were pigment mottling of the retina and chorioretinal atrophy (11 of 17 abnormal eyes); optic nerve abnormalities (8 eyes); and iris coloboma (affecting 2 eyes in one infant).
While a previous study of a Zika virus outbreak in Micronesia found conjunctivitis among infected individuals, none of the mothers of the current cohort of infants disclosed having had conjunctivitis. Altogether 23 of the mothers (79%) reported having had any symptoms of Zika virus infection during pregnancy.
Dr. de Paula Freitas and his colleagues acknowledged that their results were limited by a small sample size and single-site study design. However, the investigators noted, the findings suggest the possibility “that even oligosymptomatic or asymptomatic pregnant patients presumably infected [with Zika virus] may have microcephalic newborns with ophthalmoscopic lesions” and those newborns should be routinely evaluated for ocular symptoms.
An important question that requires further investigation, they noted, is whether newborns without microcephaly, but whose mothers may have been infected with the Zika virus, should be screened to identify possible ocular lesions.
Funding for the study came from Hospital Geral Roberto Santos, Federal University of São Paulo, Vision Institute, and Conselho Nacional de Desenvolvimento Científico e Tecnológico in Brasília, Brazil. The authors reported having no financial disclosures.
Ophthalmologic manifestations of congenital Zika virus infection are not yet well described. The report by de Paula Freitas et al. implicates this infection as the cause of chorioretinal scarring and possibly other ocular abnormalities in infants with microcephaly recently born in Brazil.
Microcephaly can be genetic, metabolic, drug related, or caused by perinatal insults such as hypoxia, malnutrition, or infection. The present 20-fold reported increase of microcephaly in parts of Brazil is temporally associated with the outbreak of Zika virus. However, this association is still presumptive because definitive serologic testing for Zika virus was not available in Brazil at the time of the outbreak, and confusion may occur with other causes of microcephaly. Similarly, the currently described eye lesions are presumptively associated with the virus.
Based on current information, in our opinion, clinicians in areas where Zika virus is present should perform ophthalmologic examinations on all microcephalic babies. Because it is still unclear whether the eye lesions occur in the absence of microcephaly, it is premature to suggest ophthalmic screening of all babies born in epidemic areas.
Dr. Lee M. Jampol and Dr. Debra A Goldstein are from the department of ophthalmology, Northwestern University, Chicago. These comments are excerpted from an accompanying editorial (JAMA Ophthalmol. doi:10.1001/jamaopthalmol.2016.0284.). The authors reported having no financial disclosures.
Ophthalmologic manifestations of congenital Zika virus infection are not yet well described. The report by de Paula Freitas et al. implicates this infection as the cause of chorioretinal scarring and possibly other ocular abnormalities in infants with microcephaly recently born in Brazil.
Microcephaly can be genetic, metabolic, drug related, or caused by perinatal insults such as hypoxia, malnutrition, or infection. The present 20-fold reported increase of microcephaly in parts of Brazil is temporally associated with the outbreak of Zika virus. However, this association is still presumptive because definitive serologic testing for Zika virus was not available in Brazil at the time of the outbreak, and confusion may occur with other causes of microcephaly. Similarly, the currently described eye lesions are presumptively associated with the virus.
Based on current information, in our opinion, clinicians in areas where Zika virus is present should perform ophthalmologic examinations on all microcephalic babies. Because it is still unclear whether the eye lesions occur in the absence of microcephaly, it is premature to suggest ophthalmic screening of all babies born in epidemic areas.
Dr. Lee M. Jampol and Dr. Debra A Goldstein are from the department of ophthalmology, Northwestern University, Chicago. These comments are excerpted from an accompanying editorial (JAMA Ophthalmol. doi:10.1001/jamaopthalmol.2016.0284.). The authors reported having no financial disclosures.
Ophthalmologic manifestations of congenital Zika virus infection are not yet well described. The report by de Paula Freitas et al. implicates this infection as the cause of chorioretinal scarring and possibly other ocular abnormalities in infants with microcephaly recently born in Brazil.
Microcephaly can be genetic, metabolic, drug related, or caused by perinatal insults such as hypoxia, malnutrition, or infection. The present 20-fold reported increase of microcephaly in parts of Brazil is temporally associated with the outbreak of Zika virus. However, this association is still presumptive because definitive serologic testing for Zika virus was not available in Brazil at the time of the outbreak, and confusion may occur with other causes of microcephaly. Similarly, the currently described eye lesions are presumptively associated with the virus.
Based on current information, in our opinion, clinicians in areas where Zika virus is present should perform ophthalmologic examinations on all microcephalic babies. Because it is still unclear whether the eye lesions occur in the absence of microcephaly, it is premature to suggest ophthalmic screening of all babies born in epidemic areas.
Dr. Lee M. Jampol and Dr. Debra A Goldstein are from the department of ophthalmology, Northwestern University, Chicago. These comments are excerpted from an accompanying editorial (JAMA Ophthalmol. doi:10.1001/jamaopthalmol.2016.0284.). The authors reported having no financial disclosures.
In a sample of infants born with microcephaly and a presumed diagnosis of congenital Zika virus, about one-third were found to have vision-threatening eye abnormalities, according to researchers working in a Zika hot spot in Brazil.
The group, led by Dr. Bruno de Paula Freitas of the Hospital Geral Roberto Santos, in Salvador, Brazil, evaluated 29 infants with microcephaly born at a single hospital in December following suspected maternal infection with the mosquito-borne Zika virus. In a paper published online Feb 9., Dr. de Paula Freitas and his colleagues reported eye abnormalities in 10 of these children (34.5%) (JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2016.0267.).
Brazil first reported an outbreak of Zika virus infections in April 2015, followed months later by a spike in the number of infants born with microcephaly, a birth defect defined by a cephalic circumference of 32 cm or less in newborns. The most common ocular abnormalities seen in the cohort of affected infants were pigment mottling of the retina and chorioretinal atrophy (11 of 17 abnormal eyes); optic nerve abnormalities (8 eyes); and iris coloboma (affecting 2 eyes in one infant).
While a previous study of a Zika virus outbreak in Micronesia found conjunctivitis among infected individuals, none of the mothers of the current cohort of infants disclosed having had conjunctivitis. Altogether 23 of the mothers (79%) reported having had any symptoms of Zika virus infection during pregnancy.
Dr. de Paula Freitas and his colleagues acknowledged that their results were limited by a small sample size and single-site study design. However, the investigators noted, the findings suggest the possibility “that even oligosymptomatic or asymptomatic pregnant patients presumably infected [with Zika virus] may have microcephalic newborns with ophthalmoscopic lesions” and those newborns should be routinely evaluated for ocular symptoms.
An important question that requires further investigation, they noted, is whether newborns without microcephaly, but whose mothers may have been infected with the Zika virus, should be screened to identify possible ocular lesions.
Funding for the study came from Hospital Geral Roberto Santos, Federal University of São Paulo, Vision Institute, and Conselho Nacional de Desenvolvimento Científico e Tecnológico in Brasília, Brazil. The authors reported having no financial disclosures.
In a sample of infants born with microcephaly and a presumed diagnosis of congenital Zika virus, about one-third were found to have vision-threatening eye abnormalities, according to researchers working in a Zika hot spot in Brazil.
The group, led by Dr. Bruno de Paula Freitas of the Hospital Geral Roberto Santos, in Salvador, Brazil, evaluated 29 infants with microcephaly born at a single hospital in December following suspected maternal infection with the mosquito-borne Zika virus. In a paper published online Feb 9., Dr. de Paula Freitas and his colleagues reported eye abnormalities in 10 of these children (34.5%) (JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2016.0267.).
Brazil first reported an outbreak of Zika virus infections in April 2015, followed months later by a spike in the number of infants born with microcephaly, a birth defect defined by a cephalic circumference of 32 cm or less in newborns. The most common ocular abnormalities seen in the cohort of affected infants were pigment mottling of the retina and chorioretinal atrophy (11 of 17 abnormal eyes); optic nerve abnormalities (8 eyes); and iris coloboma (affecting 2 eyes in one infant).
While a previous study of a Zika virus outbreak in Micronesia found conjunctivitis among infected individuals, none of the mothers of the current cohort of infants disclosed having had conjunctivitis. Altogether 23 of the mothers (79%) reported having had any symptoms of Zika virus infection during pregnancy.
Dr. de Paula Freitas and his colleagues acknowledged that their results were limited by a small sample size and single-site study design. However, the investigators noted, the findings suggest the possibility “that even oligosymptomatic or asymptomatic pregnant patients presumably infected [with Zika virus] may have microcephalic newborns with ophthalmoscopic lesions” and those newborns should be routinely evaluated for ocular symptoms.
An important question that requires further investigation, they noted, is whether newborns without microcephaly, but whose mothers may have been infected with the Zika virus, should be screened to identify possible ocular lesions.
Funding for the study came from Hospital Geral Roberto Santos, Federal University of São Paulo, Vision Institute, and Conselho Nacional de Desenvolvimento Científico e Tecnológico in Brasília, Brazil. The authors reported having no financial disclosures.
FROM JAMA OPTHALMOLOGY
Key clinical point: Serious ocular abnormalities may accompany microcephaly in babies born to mothers infected with the Zika virus.
Major finding: More than one-third (34.5%) of a cohort of 29 infants born with microcephaly and with a presumed diagnosis of congenital Zika virus had ocular abnormalities in one or both eyes.
Data source: A single-site cohort study evaluating 29 infants born with microcephaly in a single hospital in Salvador, Brazil.
Disclosures: Funding for the study came from Hospital Geral Roberto Santos, Federal University of São Paulo, Vision Institute, and Conselho Nacional de Desenvolvimento Científico e Tecnológico in Brasília, Brazil. The authors reported having no financial disclosures.
TEP hernia repair superior to Lichtenstein in pain outcomes
Patients undergoing endoscopic total extraperitoneal repair (TEP) of hernias had less persistent pain and greater mobility than those whose hernias were repaired using the Lichtenstein technique.
For their research, conducted in Sweden, researchers led by Dr. Linn Westin of the Karolinska Institutet in Stockholm and colleagues randomized 384 adult men with primary unilateral inguinal hernia to surgery with Lichtenstein using local anesthesia (n = 191) or TEP with general anesthesia (n = 193). Patients underwent operations in two hospitals between 2006 and 2011, with four surgeons participating, and the same heavyweight mesh was used in both groups.
All patients were followed for 1 year for postoperative pain, recurrence of hernias, difficulty in performing daily activities, complications, and use of analgesics. Pain was measured using the Inguinal Pain Questionnaire (IPQ).
In a paper published in the February issue of Annals of Surgery (2016;263:240-3), Dr. Westin and colleagues reported that the group randomized to TEP saw significantly less persistent mild pain at 1 year, compared with the Lichtenstein group. In the TEP group 39 patients reported such pain, compared with 62 in the Lichtenstein group (20.7% vs. 33.2,% P = .007).
Five TEP patients reported pain in the groin that limited their ability to perform physical exercise, while 14 in the Lichtenstein group reported similar pain, a difference that reached statistical significance (2.7% vs. 7.5%, P = .034). Severe pain, defined as pain affecting most activities, was comparable in both groups, with four patients in the TEP group and six in the Lichtenstein group reporting severe pain (2.1% and 3.2%, P = .543).
No significant between-group differences were seen in recurrences, use of pain medications, or specific measures of mobility, such as being able to sit or stand for more than 30 minutes at a stretch.
“Our results show a clinically significant advantage in favor of TEP regarding long-term postoperative pain, and justify the use of TEP for routine inguinal hernia surgery,” Dr. Westin and colleagues noted in their analysis. Their findings, they said, should prompt more extensive training of surgeons in the TEP technique.
The investigators noted as a limitation of their study that it was not powered to detect differences in severe pain, which could be considered more clinically relevant than mild persistent pain.
Patients’ pain outcomes may have been related to surgeons’ handling of the nerves in the inguinal tract, they wrote.
Also, they noted, the same heavyweight mesh was used in all operations in the study, for consistency, despite the fact that, after the initiation of the trial, lightweight mesh was shown in studies to be associated with less pain. Dr. Westin and colleagues wrote that their findings would be applicable to surgeries using lightweight mesh, which might further limit pain.
Their results, they wrote, suggested that TEP should be considered a valid first choice not only for the study population, which included only men with primary unilateral hernias, but for those with bilateral or recurrent hernias and also for women.
The study was funded by the Uppsala-Orebro Regional Research Council, Stockholm County Council, Swedish Society of Medicine, and Olle Engqvist Research Foundation. None of the investigators declared conflicts of interest.
Patients undergoing endoscopic total extraperitoneal repair (TEP) of hernias had less persistent pain and greater mobility than those whose hernias were repaired using the Lichtenstein technique.
For their research, conducted in Sweden, researchers led by Dr. Linn Westin of the Karolinska Institutet in Stockholm and colleagues randomized 384 adult men with primary unilateral inguinal hernia to surgery with Lichtenstein using local anesthesia (n = 191) or TEP with general anesthesia (n = 193). Patients underwent operations in two hospitals between 2006 and 2011, with four surgeons participating, and the same heavyweight mesh was used in both groups.
All patients were followed for 1 year for postoperative pain, recurrence of hernias, difficulty in performing daily activities, complications, and use of analgesics. Pain was measured using the Inguinal Pain Questionnaire (IPQ).
In a paper published in the February issue of Annals of Surgery (2016;263:240-3), Dr. Westin and colleagues reported that the group randomized to TEP saw significantly less persistent mild pain at 1 year, compared with the Lichtenstein group. In the TEP group 39 patients reported such pain, compared with 62 in the Lichtenstein group (20.7% vs. 33.2,% P = .007).
Five TEP patients reported pain in the groin that limited their ability to perform physical exercise, while 14 in the Lichtenstein group reported similar pain, a difference that reached statistical significance (2.7% vs. 7.5%, P = .034). Severe pain, defined as pain affecting most activities, was comparable in both groups, with four patients in the TEP group and six in the Lichtenstein group reporting severe pain (2.1% and 3.2%, P = .543).
No significant between-group differences were seen in recurrences, use of pain medications, or specific measures of mobility, such as being able to sit or stand for more than 30 minutes at a stretch.
“Our results show a clinically significant advantage in favor of TEP regarding long-term postoperative pain, and justify the use of TEP for routine inguinal hernia surgery,” Dr. Westin and colleagues noted in their analysis. Their findings, they said, should prompt more extensive training of surgeons in the TEP technique.
The investigators noted as a limitation of their study that it was not powered to detect differences in severe pain, which could be considered more clinically relevant than mild persistent pain.
Patients’ pain outcomes may have been related to surgeons’ handling of the nerves in the inguinal tract, they wrote.
Also, they noted, the same heavyweight mesh was used in all operations in the study, for consistency, despite the fact that, after the initiation of the trial, lightweight mesh was shown in studies to be associated with less pain. Dr. Westin and colleagues wrote that their findings would be applicable to surgeries using lightweight mesh, which might further limit pain.
Their results, they wrote, suggested that TEP should be considered a valid first choice not only for the study population, which included only men with primary unilateral hernias, but for those with bilateral or recurrent hernias and also for women.
The study was funded by the Uppsala-Orebro Regional Research Council, Stockholm County Council, Swedish Society of Medicine, and Olle Engqvist Research Foundation. None of the investigators declared conflicts of interest.
Patients undergoing endoscopic total extraperitoneal repair (TEP) of hernias had less persistent pain and greater mobility than those whose hernias were repaired using the Lichtenstein technique.
For their research, conducted in Sweden, researchers led by Dr. Linn Westin of the Karolinska Institutet in Stockholm and colleagues randomized 384 adult men with primary unilateral inguinal hernia to surgery with Lichtenstein using local anesthesia (n = 191) or TEP with general anesthesia (n = 193). Patients underwent operations in two hospitals between 2006 and 2011, with four surgeons participating, and the same heavyweight mesh was used in both groups.
All patients were followed for 1 year for postoperative pain, recurrence of hernias, difficulty in performing daily activities, complications, and use of analgesics. Pain was measured using the Inguinal Pain Questionnaire (IPQ).
In a paper published in the February issue of Annals of Surgery (2016;263:240-3), Dr. Westin and colleagues reported that the group randomized to TEP saw significantly less persistent mild pain at 1 year, compared with the Lichtenstein group. In the TEP group 39 patients reported such pain, compared with 62 in the Lichtenstein group (20.7% vs. 33.2,% P = .007).
Five TEP patients reported pain in the groin that limited their ability to perform physical exercise, while 14 in the Lichtenstein group reported similar pain, a difference that reached statistical significance (2.7% vs. 7.5%, P = .034). Severe pain, defined as pain affecting most activities, was comparable in both groups, with four patients in the TEP group and six in the Lichtenstein group reporting severe pain (2.1% and 3.2%, P = .543).
No significant between-group differences were seen in recurrences, use of pain medications, or specific measures of mobility, such as being able to sit or stand for more than 30 minutes at a stretch.
“Our results show a clinically significant advantage in favor of TEP regarding long-term postoperative pain, and justify the use of TEP for routine inguinal hernia surgery,” Dr. Westin and colleagues noted in their analysis. Their findings, they said, should prompt more extensive training of surgeons in the TEP technique.
The investigators noted as a limitation of their study that it was not powered to detect differences in severe pain, which could be considered more clinically relevant than mild persistent pain.
Patients’ pain outcomes may have been related to surgeons’ handling of the nerves in the inguinal tract, they wrote.
Also, they noted, the same heavyweight mesh was used in all operations in the study, for consistency, despite the fact that, after the initiation of the trial, lightweight mesh was shown in studies to be associated with less pain. Dr. Westin and colleagues wrote that their findings would be applicable to surgeries using lightweight mesh, which might further limit pain.
Their results, they wrote, suggested that TEP should be considered a valid first choice not only for the study population, which included only men with primary unilateral hernias, but for those with bilateral or recurrent hernias and also for women.
The study was funded by the Uppsala-Orebro Regional Research Council, Stockholm County Council, Swedish Society of Medicine, and Olle Engqvist Research Foundation. None of the investigators declared conflicts of interest.
FROM ANNALS OF SURGERY
Key clinical point: Patients undergoing TEP for hernia repair were less likely to report persistent pain after 1 year than those undergoing Lichtenstein procedures.
Major finding: In the TEP group, 39 (20.7%) patients reported persistent pain, compared with 62 (33.2%) in the Lichtenstein group (P = .007).
Data source: A randomized multisite surgical trial in Sweden enrolling 384 men with unilateral primary inguinal hernias, with 375 followed up at 1 year.
Disclosures: The study was funded by Swedish government grants, the Swedish Society of Medicine, and the Olle Engqvist Research Foundation. Investigators disclosed no conflicts of interest.
More Than 15% of Reproductive Age Women Use Antidepressants
About 15% of women of childbearing age filled prescriptions for antidepressants at least once a year during 2008-2013, according to a new report from the Centers for Disease Control and Prevention.
Women between the ages of 35 and 44 years made up the largest share of those filling an antidepressant prescription. The most commonly filled prescriptions were for sertraline, bupropion, and citalopram (Morb Mortal Wkly Rep. 2016 Jan 29;65:41-6).
The analysis is based on prescription information from a database of employer-sponsored insurance plans representing an average of 5.8 million women aged 15-44 years for each year of the study.
The findings raise public health concerns given the possible association between some antidepressants and birth defects and the large number of unintended pregnancies, wrote the investigators, led by April L. Dawson of the CDC’s National Center on Birth Defects and Developmental Disabilities.
A recent analysis of the National Birth Defects Prevention Study data found that paroxetine and fluoxetine, both SSRIs, were linked with a higher rate of some birth defects, including cardiac abnormalities, though the increase in absolute risk was small (BMJ 2015;351:h3190).
“Prescribing of antidepressants is common, and research on antidepressant safety during pregnancy needs to be accelerated to provide evidence-based information to health care providers and women about the potential risks for antidepressant exposure before and during pregnancy and between pregnancies,” Ms. Dawson and her colleagues wrote.
The study authors were employees of the CDC or the March of Dimes Foundation.
About 15% of women of childbearing age filled prescriptions for antidepressants at least once a year during 2008-2013, according to a new report from the Centers for Disease Control and Prevention.
Women between the ages of 35 and 44 years made up the largest share of those filling an antidepressant prescription. The most commonly filled prescriptions were for sertraline, bupropion, and citalopram (Morb Mortal Wkly Rep. 2016 Jan 29;65:41-6).
The analysis is based on prescription information from a database of employer-sponsored insurance plans representing an average of 5.8 million women aged 15-44 years for each year of the study.
The findings raise public health concerns given the possible association between some antidepressants and birth defects and the large number of unintended pregnancies, wrote the investigators, led by April L. Dawson of the CDC’s National Center on Birth Defects and Developmental Disabilities.
A recent analysis of the National Birth Defects Prevention Study data found that paroxetine and fluoxetine, both SSRIs, were linked with a higher rate of some birth defects, including cardiac abnormalities, though the increase in absolute risk was small (BMJ 2015;351:h3190).
“Prescribing of antidepressants is common, and research on antidepressant safety during pregnancy needs to be accelerated to provide evidence-based information to health care providers and women about the potential risks for antidepressant exposure before and during pregnancy and between pregnancies,” Ms. Dawson and her colleagues wrote.
The study authors were employees of the CDC or the March of Dimes Foundation.
About 15% of women of childbearing age filled prescriptions for antidepressants at least once a year during 2008-2013, according to a new report from the Centers for Disease Control and Prevention.
Women between the ages of 35 and 44 years made up the largest share of those filling an antidepressant prescription. The most commonly filled prescriptions were for sertraline, bupropion, and citalopram (Morb Mortal Wkly Rep. 2016 Jan 29;65:41-6).
The analysis is based on prescription information from a database of employer-sponsored insurance plans representing an average of 5.8 million women aged 15-44 years for each year of the study.
The findings raise public health concerns given the possible association between some antidepressants and birth defects and the large number of unintended pregnancies, wrote the investigators, led by April L. Dawson of the CDC’s National Center on Birth Defects and Developmental Disabilities.
A recent analysis of the National Birth Defects Prevention Study data found that paroxetine and fluoxetine, both SSRIs, were linked with a higher rate of some birth defects, including cardiac abnormalities, though the increase in absolute risk was small (BMJ 2015;351:h3190).
“Prescribing of antidepressants is common, and research on antidepressant safety during pregnancy needs to be accelerated to provide evidence-based information to health care providers and women about the potential risks for antidepressant exposure before and during pregnancy and between pregnancies,” Ms. Dawson and her colleagues wrote.
The study authors were employees of the CDC or the March of Dimes Foundation.
FROM MMWR
More than 15% of reproductive age women use antidepressants
About 15% of women of childbearing age filled prescriptions for antidepressants at least once a year during 2008-2013, according to a new report from the Centers for Disease Control and Prevention.
Women between the ages of 35 and 44 years made up the largest share of those filling an antidepressant prescription. The most commonly filled prescriptions were for sertraline, bupropion, and citalopram (Morb Mortal Wkly Rep. 2016 Jan 29;65:41-6).
The analysis is based on prescription information from a database of employer-sponsored insurance plans representing an average of 5.8 million women aged 15-44 years for each year of the study.
The findings raise public health concerns given the possible association between some antidepressants and birth defects and the large number of unintended pregnancies, wrote the investigators, led by April L. Dawson of the CDC’s National Center on Birth Defects and Developmental Disabilities.
A recent analysis of the National Birth Defects Prevention Study data found that paroxetine and fluoxetine, both SSRIs, were linked with a higher rate of some birth defects, including cardiac abnormalities, though the increase in absolute risk was small (BMJ 2015;351:h3190).
“Prescribing of antidepressants is common, and research on antidepressant safety during pregnancy needs to be accelerated to provide evidence-based information to health care providers and women about the potential risks for antidepressant exposure before and during pregnancy and between pregnancies,” Ms. Dawson and her colleagues wrote.
The study authors were employees of the CDC or the March of Dimes Foundation.
About 15% of women of childbearing age filled prescriptions for antidepressants at least once a year during 2008-2013, according to a new report from the Centers for Disease Control and Prevention.
Women between the ages of 35 and 44 years made up the largest share of those filling an antidepressant prescription. The most commonly filled prescriptions were for sertraline, bupropion, and citalopram (Morb Mortal Wkly Rep. 2016 Jan 29;65:41-6).
The analysis is based on prescription information from a database of employer-sponsored insurance plans representing an average of 5.8 million women aged 15-44 years for each year of the study.
The findings raise public health concerns given the possible association between some antidepressants and birth defects and the large number of unintended pregnancies, wrote the investigators, led by April L. Dawson of the CDC’s National Center on Birth Defects and Developmental Disabilities.
A recent analysis of the National Birth Defects Prevention Study data found that paroxetine and fluoxetine, both SSRIs, were linked with a higher rate of some birth defects, including cardiac abnormalities, though the increase in absolute risk was small (BMJ 2015;351:h3190).
“Prescribing of antidepressants is common, and research on antidepressant safety during pregnancy needs to be accelerated to provide evidence-based information to health care providers and women about the potential risks for antidepressant exposure before and during pregnancy and between pregnancies,” Ms. Dawson and her colleagues wrote.
The study authors were employees of the CDC or the March of Dimes Foundation.
About 15% of women of childbearing age filled prescriptions for antidepressants at least once a year during 2008-2013, according to a new report from the Centers for Disease Control and Prevention.
Women between the ages of 35 and 44 years made up the largest share of those filling an antidepressant prescription. The most commonly filled prescriptions were for sertraline, bupropion, and citalopram (Morb Mortal Wkly Rep. 2016 Jan 29;65:41-6).
The analysis is based on prescription information from a database of employer-sponsored insurance plans representing an average of 5.8 million women aged 15-44 years for each year of the study.
The findings raise public health concerns given the possible association between some antidepressants and birth defects and the large number of unintended pregnancies, wrote the investigators, led by April L. Dawson of the CDC’s National Center on Birth Defects and Developmental Disabilities.
A recent analysis of the National Birth Defects Prevention Study data found that paroxetine and fluoxetine, both SSRIs, were linked with a higher rate of some birth defects, including cardiac abnormalities, though the increase in absolute risk was small (BMJ 2015;351:h3190).
“Prescribing of antidepressants is common, and research on antidepressant safety during pregnancy needs to be accelerated to provide evidence-based information to health care providers and women about the potential risks for antidepressant exposure before and during pregnancy and between pregnancies,” Ms. Dawson and her colleagues wrote.
The study authors were employees of the CDC or the March of Dimes Foundation.
FROM MMWR
Key clinical point: About 15% of reproductive-age women use antidepressants each year.
Major finding: A total of 15.4% of women aged 15-44 years filled at least one prescription annually for an antidepressant during 2008-2013.
Data source: A retrospective analysis of data from a commercial database that included an average of 5.8 million women with private, employer-sponsored insurance.
Disclosures: Study authors were employees of the CDC or the March of Dimes Foundation.
Pain scores point to hospital quality in colorectal surgery
Post-surgical pain scores may be an overlooked quality indicator among hospitals, according to new research linking patient-reported pain scores with institutional pain management practices and also surgical outcomes.
A retrospective cohort study of patient-reported pain scores after colorectal resections at 52 Michigan hospitals, published in Annals of Surgery (2016 Jan 7; epub ahead of print; doi: 10.1097/SLA.0000000000001541), found that patients treated at the best-performing hospitals for postoperative pain scores were more likely to have received patient-controlled analgesia, compared with those in the worst-performing ones (56.5% vs. 22.8%; P less than .001).
For their research, Dr. Scott E. Regenbogen of the University of Michigan, Ann Arbor, and his colleagues looked at patient-reported pain scores on the first morning post-surgery for 7,221 colorectal operations between 2012 and 2014. The participating hospitals were part of a statewide collaborative that collects data on surgery patients with the aim of improving quality.
Dr. Regenbogen and his colleagues found that patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
In addition, Dr. Regenbogen and his colleagues found postoperative emergency department visits, readmissions, and pulmonary complications to be significantly lower in the quartile of hospitals with the best pain scores. The fewer pulmonary complications seen linked with better pain control “could be an indicator of better pulmonary toilet or lesser respiratory depression,” they noted.
The correlation between surgical outcomes and pain scores, the investigators wrote, suggests “consistency in the overall quality performance across both clinical and patient-reported outcomes for colectomy.”
Mean self-rated pain scores, in which patients characterize the intensity of their pain on a scale of 0 to 10, ranged from 4 to 6 across the hospitals in the study, with 5.1 (standard deviation 2.44) reported for the cohort as a whole. The type of surgery also affected pain scores, with minimally invasive procedures associated with lower scores, compared with open or converted procedures. The type of anesthesia used (local or epidural) also significantly affected scores.
Hospitals with better pain scores tended to be somewhat larger than those with poor scores, and performed more colorectal resections per year, the investigators found.
The researchers noted that while a previous meta-analysis showed that patient-controlled analgesia post-surgery provided superior pain control, compared with intermittent treatment (Cochrane Database Syst Rev. 2006 Oct 18;18:CD003348), the hospitals in this study varied widely in their approaches, with 89% of the poorly performing quartile of hospitals using intermittent parenteral narcotics, compared with 66% in the best-performing quartile.
Dr. Regenbogen and his colleagues noted in their analysis that it was possible that the association between pain control and clinical outcomes such as readmissions and complications was driven by case or patient complexity differences among institutions. The 52 hospitals in the study varied in size and type, with community and academic hospitals as well as rural and urban institutions represented.
However, they wrote, it is more likely that “both pain scores and clinical outcomes reflect … global features of the quality of care in hospitals’ surgical performance. Thus, hospitals with the most streamlined, high-quality perioperative care pathways experience the best pain scores, as well as improved clinical outcomes.”
The findings, they concluded, “reveal systematic clinical care variation that could be reduced to improve patients’ experience of pain after colorectal resections.”
The researchers noted as a limitation of the study its reliance on patient-reported pain measures, and that it did not include data on patients’ pain history, opioid use prior to admission, or the administration of pre-emptive analgesia before surgery. The study was funded by the Michigan Surgical Quality Collaborative, which receives support from Blue Cross Blue Shield. None of the study authors declared conflicts of interest.
Post-surgical pain scores may be an overlooked quality indicator among hospitals, according to new research linking patient-reported pain scores with institutional pain management practices and also surgical outcomes.
A retrospective cohort study of patient-reported pain scores after colorectal resections at 52 Michigan hospitals, published in Annals of Surgery (2016 Jan 7; epub ahead of print; doi: 10.1097/SLA.0000000000001541), found that patients treated at the best-performing hospitals for postoperative pain scores were more likely to have received patient-controlled analgesia, compared with those in the worst-performing ones (56.5% vs. 22.8%; P less than .001).
For their research, Dr. Scott E. Regenbogen of the University of Michigan, Ann Arbor, and his colleagues looked at patient-reported pain scores on the first morning post-surgery for 7,221 colorectal operations between 2012 and 2014. The participating hospitals were part of a statewide collaborative that collects data on surgery patients with the aim of improving quality.
Dr. Regenbogen and his colleagues found that patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
In addition, Dr. Regenbogen and his colleagues found postoperative emergency department visits, readmissions, and pulmonary complications to be significantly lower in the quartile of hospitals with the best pain scores. The fewer pulmonary complications seen linked with better pain control “could be an indicator of better pulmonary toilet or lesser respiratory depression,” they noted.
The correlation between surgical outcomes and pain scores, the investigators wrote, suggests “consistency in the overall quality performance across both clinical and patient-reported outcomes for colectomy.”
Mean self-rated pain scores, in which patients characterize the intensity of their pain on a scale of 0 to 10, ranged from 4 to 6 across the hospitals in the study, with 5.1 (standard deviation 2.44) reported for the cohort as a whole. The type of surgery also affected pain scores, with minimally invasive procedures associated with lower scores, compared with open or converted procedures. The type of anesthesia used (local or epidural) also significantly affected scores.
Hospitals with better pain scores tended to be somewhat larger than those with poor scores, and performed more colorectal resections per year, the investigators found.
The researchers noted that while a previous meta-analysis showed that patient-controlled analgesia post-surgery provided superior pain control, compared with intermittent treatment (Cochrane Database Syst Rev. 2006 Oct 18;18:CD003348), the hospitals in this study varied widely in their approaches, with 89% of the poorly performing quartile of hospitals using intermittent parenteral narcotics, compared with 66% in the best-performing quartile.
Dr. Regenbogen and his colleagues noted in their analysis that it was possible that the association between pain control and clinical outcomes such as readmissions and complications was driven by case or patient complexity differences among institutions. The 52 hospitals in the study varied in size and type, with community and academic hospitals as well as rural and urban institutions represented.
However, they wrote, it is more likely that “both pain scores and clinical outcomes reflect … global features of the quality of care in hospitals’ surgical performance. Thus, hospitals with the most streamlined, high-quality perioperative care pathways experience the best pain scores, as well as improved clinical outcomes.”
The findings, they concluded, “reveal systematic clinical care variation that could be reduced to improve patients’ experience of pain after colorectal resections.”
The researchers noted as a limitation of the study its reliance on patient-reported pain measures, and that it did not include data on patients’ pain history, opioid use prior to admission, or the administration of pre-emptive analgesia before surgery. The study was funded by the Michigan Surgical Quality Collaborative, which receives support from Blue Cross Blue Shield. None of the study authors declared conflicts of interest.
Post-surgical pain scores may be an overlooked quality indicator among hospitals, according to new research linking patient-reported pain scores with institutional pain management practices and also surgical outcomes.
A retrospective cohort study of patient-reported pain scores after colorectal resections at 52 Michigan hospitals, published in Annals of Surgery (2016 Jan 7; epub ahead of print; doi: 10.1097/SLA.0000000000001541), found that patients treated at the best-performing hospitals for postoperative pain scores were more likely to have received patient-controlled analgesia, compared with those in the worst-performing ones (56.5% vs. 22.8%; P less than .001).
For their research, Dr. Scott E. Regenbogen of the University of Michigan, Ann Arbor, and his colleagues looked at patient-reported pain scores on the first morning post-surgery for 7,221 colorectal operations between 2012 and 2014. The participating hospitals were part of a statewide collaborative that collects data on surgery patients with the aim of improving quality.
Dr. Regenbogen and his colleagues found that patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
In addition, Dr. Regenbogen and his colleagues found postoperative emergency department visits, readmissions, and pulmonary complications to be significantly lower in the quartile of hospitals with the best pain scores. The fewer pulmonary complications seen linked with better pain control “could be an indicator of better pulmonary toilet or lesser respiratory depression,” they noted.
The correlation between surgical outcomes and pain scores, the investigators wrote, suggests “consistency in the overall quality performance across both clinical and patient-reported outcomes for colectomy.”
Mean self-rated pain scores, in which patients characterize the intensity of their pain on a scale of 0 to 10, ranged from 4 to 6 across the hospitals in the study, with 5.1 (standard deviation 2.44) reported for the cohort as a whole. The type of surgery also affected pain scores, with minimally invasive procedures associated with lower scores, compared with open or converted procedures. The type of anesthesia used (local or epidural) also significantly affected scores.
Hospitals with better pain scores tended to be somewhat larger than those with poor scores, and performed more colorectal resections per year, the investigators found.
The researchers noted that while a previous meta-analysis showed that patient-controlled analgesia post-surgery provided superior pain control, compared with intermittent treatment (Cochrane Database Syst Rev. 2006 Oct 18;18:CD003348), the hospitals in this study varied widely in their approaches, with 89% of the poorly performing quartile of hospitals using intermittent parenteral narcotics, compared with 66% in the best-performing quartile.
Dr. Regenbogen and his colleagues noted in their analysis that it was possible that the association between pain control and clinical outcomes such as readmissions and complications was driven by case or patient complexity differences among institutions. The 52 hospitals in the study varied in size and type, with community and academic hospitals as well as rural and urban institutions represented.
However, they wrote, it is more likely that “both pain scores and clinical outcomes reflect … global features of the quality of care in hospitals’ surgical performance. Thus, hospitals with the most streamlined, high-quality perioperative care pathways experience the best pain scores, as well as improved clinical outcomes.”
The findings, they concluded, “reveal systematic clinical care variation that could be reduced to improve patients’ experience of pain after colorectal resections.”
The researchers noted as a limitation of the study its reliance on patient-reported pain measures, and that it did not include data on patients’ pain history, opioid use prior to admission, or the administration of pre-emptive analgesia before surgery. The study was funded by the Michigan Surgical Quality Collaborative, which receives support from Blue Cross Blue Shield. None of the study authors declared conflicts of interest.
FROM ANNALS OF SURGERY
Key clinical point: Hospitals delivering better patient-reported pain control after colorectal resection also saw better surgical outcomes.
Major finding: Patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
Data source: A retrospective cohort study reviewing more than 7,000 colorectal resections at 52 Michigan hospitals between 2012 and 2014.
Disclosures: The Michigan Surgical Quality Collaborative, funded by Blue Cross Blue Shield, sponsored the study. Investigators declared no conflicts of interest.
Chlorthalidone controls blood pressure longer than HCTZ
Low-dose chlorthalidone is significantly better at reducing blood pressure over a 24-hour period than is the most commonly prescribed formulation of hydrochlorothiazide for essential hypertension, findings from a randomized, controlled trial published Jan. 25 suggest.
Standard HCTZ at 12.5 mg was seen reducing blood pressure during daytime or office hours, resulting in undetected or masked hypertension during nighttime and early-morning hours, investigators found.
However, both 6.25 mg chlorthalidone and an extended-release preparation of 12.5 mg HCTZ were shown to be effective at sustaining a smooth, 24-hour control as measured by ambulatory blood pressure monitoring.
For their research, Dr. Anil K. Pareek of Ipca Laboratories in Mumbai, India, and his colleagues randomized 54 patients aged 65 years and younger with stage 1 hypertension and no comorbidities to chlorthalidone, 6.25 mg (16 patients); HCTZ 12.5 mg (18); or HCTZ-controlled release 12.5 mg (20) for 12 weeks.
For the cohort as a whole, patients’ mean in-office blood pressure was 149/93 mm Hg. At both 4 and 12 weeks, all three study arms saw significant reductions in office BP (P less than .01).
However, only patients treated with chlorthalidone or HCTZ-CR saw statistically significant reductions in ambulatory diastolic and systolic blood pressure at both time points, while the standard HCTZ group did not see statistically significant changes. At 12 weeks, patients treated with chlorthalidone or HCTZ-CR achieved reductions of 11.1/7.8 mm Hg, and 10.3/8.2 mm Hg, respectively, while those in the standard HCTZ arm saw drops of 6.0/4.2 mm Hg (J Am Coll Cardiol. 2016 Jan 25;67:379-89).
Also at 12 weeks, the chlorthalidone and HCTZ-CR groups had mean nocturnal systolic pressure decreases of 10.2 and 12.7 mm/Hg, respectively, while those receiving standard HCTZ saw nighttime SBP reduced by mean 4.9 mm Hg.
Low potassium was seen in 10% (n = 2) of patients taking HCTZ-CR, 5.6% of patients on standard HCTZ, and 6.3% (n = 1) of patients on chlorthalidone.
Dr. Pareek and his colleagues noted that chlorthalidone possesses a distinct pharmacokinetic profile from HCTZ, with a higher potency that allows it to be used as monotherapy in smaller doses and has “a wider volume of distribution, with partitioning into red blood cells” that may be responsible for its longer duration of action.
Dr. Pareek and his colleagues wrote that previous studies have shown an overestimation of the response to standard HCTZ, based on office blood pressure measurements alone.
“Assessing the antihypertensive efficacy of HCTZ by [office] BP measurements only is deceptive and prone to lull physicians and patients into a false sense of security,” the researchers wrote. “With HCTZ therapy, sustained hypertension merely will be converted into masked hypertension.”
Low-dose chlorthalidone can be used as monotherapy in treating essential hypertension, Dr. Pareek and his colleagues concluded, whereas standard low-dose HCTZ should no longer be considered an acceptable option.
The investigators noted as a limitation of their study its small size.
Ipca Laboratories, a manufacturer of chlorthalidone, sponsored the study, whose lead author and two coauthors are also employees of Ipca.
Despite the overwhelming cardiovascular outcome data and established 24-hour efficacy of chlorthalidone in hypertension, prescription patterns are unchanged, with HCTZ remaining the diuretic of choice due to concerns regarding hypokalemia and greater likelihood of new-onset diabetes associated with chlorthalidone. Ambulatory blood pressure monitoring data have shown that chlorthalidone has antihypertensive effects beyond 24 hours, whereas HCTZ has antihypertensive effects for roughly 12-14 hours.
It could be argued that the superiority of chlorthalidone in cardiovascular outcome trials is not attributable to its potency, but rather its duration of action, given its extended effects on nocturnal blood pressure. As such, controlled-release HCTZ was also able to achieve comparable antihypertensive effects in terms of blood pressure reduction and duration of effect. These long-acting preparations are crucial to blood pressure control during the early morning, when one is most vulnerable to CV events.
Although this trial may appear to reflect a lower rate of side effects, specifically the absence of hyponatremia, the trial duration was short, the study was underpowered to detect this outcome, and those at highest risk, that is, people older than 65 years of age, were excluded. Only one-third of those screened were enrolled, suggesting that just a fraction of the patients seen on a daily basis would fit the focused study criteria, namely those without comorbidities and younger than 65 years. Additionally, because the study was conducted in a Southeast Asian country, it remains unclear whether the results can be extrapolated to those on Western diets or of other ethnicities.
Dr. Hillel Z. Sternlicht and Dr. George Bakris of the ASH Comprehensive Hypertension Center, University of Chicago Medicine, made these comments in an accompanying editorial (J Am Coll Cardiol. 2016 Jan 25. doi: 10.1016/j.jacc.2015.11.025). Dr. Sternlicht has reported that he has no relationships relevant to this paper. Dr. Bakris disclosed financial relationships with AbbVie, Janssen, AstraZeneca, Bayer, Takeda, NxStage, and Daiichi-Sankyo.
Despite the overwhelming cardiovascular outcome data and established 24-hour efficacy of chlorthalidone in hypertension, prescription patterns are unchanged, with HCTZ remaining the diuretic of choice due to concerns regarding hypokalemia and greater likelihood of new-onset diabetes associated with chlorthalidone. Ambulatory blood pressure monitoring data have shown that chlorthalidone has antihypertensive effects beyond 24 hours, whereas HCTZ has antihypertensive effects for roughly 12-14 hours.
It could be argued that the superiority of chlorthalidone in cardiovascular outcome trials is not attributable to its potency, but rather its duration of action, given its extended effects on nocturnal blood pressure. As such, controlled-release HCTZ was also able to achieve comparable antihypertensive effects in terms of blood pressure reduction and duration of effect. These long-acting preparations are crucial to blood pressure control during the early morning, when one is most vulnerable to CV events.
Although this trial may appear to reflect a lower rate of side effects, specifically the absence of hyponatremia, the trial duration was short, the study was underpowered to detect this outcome, and those at highest risk, that is, people older than 65 years of age, were excluded. Only one-third of those screened were enrolled, suggesting that just a fraction of the patients seen on a daily basis would fit the focused study criteria, namely those without comorbidities and younger than 65 years. Additionally, because the study was conducted in a Southeast Asian country, it remains unclear whether the results can be extrapolated to those on Western diets or of other ethnicities.
Dr. Hillel Z. Sternlicht and Dr. George Bakris of the ASH Comprehensive Hypertension Center, University of Chicago Medicine, made these comments in an accompanying editorial (J Am Coll Cardiol. 2016 Jan 25. doi: 10.1016/j.jacc.2015.11.025). Dr. Sternlicht has reported that he has no relationships relevant to this paper. Dr. Bakris disclosed financial relationships with AbbVie, Janssen, AstraZeneca, Bayer, Takeda, NxStage, and Daiichi-Sankyo.
Despite the overwhelming cardiovascular outcome data and established 24-hour efficacy of chlorthalidone in hypertension, prescription patterns are unchanged, with HCTZ remaining the diuretic of choice due to concerns regarding hypokalemia and greater likelihood of new-onset diabetes associated with chlorthalidone. Ambulatory blood pressure monitoring data have shown that chlorthalidone has antihypertensive effects beyond 24 hours, whereas HCTZ has antihypertensive effects for roughly 12-14 hours.
It could be argued that the superiority of chlorthalidone in cardiovascular outcome trials is not attributable to its potency, but rather its duration of action, given its extended effects on nocturnal blood pressure. As such, controlled-release HCTZ was also able to achieve comparable antihypertensive effects in terms of blood pressure reduction and duration of effect. These long-acting preparations are crucial to blood pressure control during the early morning, when one is most vulnerable to CV events.
Although this trial may appear to reflect a lower rate of side effects, specifically the absence of hyponatremia, the trial duration was short, the study was underpowered to detect this outcome, and those at highest risk, that is, people older than 65 years of age, were excluded. Only one-third of those screened were enrolled, suggesting that just a fraction of the patients seen on a daily basis would fit the focused study criteria, namely those without comorbidities and younger than 65 years. Additionally, because the study was conducted in a Southeast Asian country, it remains unclear whether the results can be extrapolated to those on Western diets or of other ethnicities.
Dr. Hillel Z. Sternlicht and Dr. George Bakris of the ASH Comprehensive Hypertension Center, University of Chicago Medicine, made these comments in an accompanying editorial (J Am Coll Cardiol. 2016 Jan 25. doi: 10.1016/j.jacc.2015.11.025). Dr. Sternlicht has reported that he has no relationships relevant to this paper. Dr. Bakris disclosed financial relationships with AbbVie, Janssen, AstraZeneca, Bayer, Takeda, NxStage, and Daiichi-Sankyo.
Low-dose chlorthalidone is significantly better at reducing blood pressure over a 24-hour period than is the most commonly prescribed formulation of hydrochlorothiazide for essential hypertension, findings from a randomized, controlled trial published Jan. 25 suggest.
Standard HCTZ at 12.5 mg was seen reducing blood pressure during daytime or office hours, resulting in undetected or masked hypertension during nighttime and early-morning hours, investigators found.
However, both 6.25 mg chlorthalidone and an extended-release preparation of 12.5 mg HCTZ were shown to be effective at sustaining a smooth, 24-hour control as measured by ambulatory blood pressure monitoring.
For their research, Dr. Anil K. Pareek of Ipca Laboratories in Mumbai, India, and his colleagues randomized 54 patients aged 65 years and younger with stage 1 hypertension and no comorbidities to chlorthalidone, 6.25 mg (16 patients); HCTZ 12.5 mg (18); or HCTZ-controlled release 12.5 mg (20) for 12 weeks.
For the cohort as a whole, patients’ mean in-office blood pressure was 149/93 mm Hg. At both 4 and 12 weeks, all three study arms saw significant reductions in office BP (P less than .01).
However, only patients treated with chlorthalidone or HCTZ-CR saw statistically significant reductions in ambulatory diastolic and systolic blood pressure at both time points, while the standard HCTZ group did not see statistically significant changes. At 12 weeks, patients treated with chlorthalidone or HCTZ-CR achieved reductions of 11.1/7.8 mm Hg, and 10.3/8.2 mm Hg, respectively, while those in the standard HCTZ arm saw drops of 6.0/4.2 mm Hg (J Am Coll Cardiol. 2016 Jan 25;67:379-89).
Also at 12 weeks, the chlorthalidone and HCTZ-CR groups had mean nocturnal systolic pressure decreases of 10.2 and 12.7 mm/Hg, respectively, while those receiving standard HCTZ saw nighttime SBP reduced by mean 4.9 mm Hg.
Low potassium was seen in 10% (n = 2) of patients taking HCTZ-CR, 5.6% of patients on standard HCTZ, and 6.3% (n = 1) of patients on chlorthalidone.
Dr. Pareek and his colleagues noted that chlorthalidone possesses a distinct pharmacokinetic profile from HCTZ, with a higher potency that allows it to be used as monotherapy in smaller doses and has “a wider volume of distribution, with partitioning into red blood cells” that may be responsible for its longer duration of action.
Dr. Pareek and his colleagues wrote that previous studies have shown an overestimation of the response to standard HCTZ, based on office blood pressure measurements alone.
“Assessing the antihypertensive efficacy of HCTZ by [office] BP measurements only is deceptive and prone to lull physicians and patients into a false sense of security,” the researchers wrote. “With HCTZ therapy, sustained hypertension merely will be converted into masked hypertension.”
Low-dose chlorthalidone can be used as monotherapy in treating essential hypertension, Dr. Pareek and his colleagues concluded, whereas standard low-dose HCTZ should no longer be considered an acceptable option.
The investigators noted as a limitation of their study its small size.
Ipca Laboratories, a manufacturer of chlorthalidone, sponsored the study, whose lead author and two coauthors are also employees of Ipca.
Low-dose chlorthalidone is significantly better at reducing blood pressure over a 24-hour period than is the most commonly prescribed formulation of hydrochlorothiazide for essential hypertension, findings from a randomized, controlled trial published Jan. 25 suggest.
Standard HCTZ at 12.5 mg was seen reducing blood pressure during daytime or office hours, resulting in undetected or masked hypertension during nighttime and early-morning hours, investigators found.
However, both 6.25 mg chlorthalidone and an extended-release preparation of 12.5 mg HCTZ were shown to be effective at sustaining a smooth, 24-hour control as measured by ambulatory blood pressure monitoring.
For their research, Dr. Anil K. Pareek of Ipca Laboratories in Mumbai, India, and his colleagues randomized 54 patients aged 65 years and younger with stage 1 hypertension and no comorbidities to chlorthalidone, 6.25 mg (16 patients); HCTZ 12.5 mg (18); or HCTZ-controlled release 12.5 mg (20) for 12 weeks.
For the cohort as a whole, patients’ mean in-office blood pressure was 149/93 mm Hg. At both 4 and 12 weeks, all three study arms saw significant reductions in office BP (P less than .01).
However, only patients treated with chlorthalidone or HCTZ-CR saw statistically significant reductions in ambulatory diastolic and systolic blood pressure at both time points, while the standard HCTZ group did not see statistically significant changes. At 12 weeks, patients treated with chlorthalidone or HCTZ-CR achieved reductions of 11.1/7.8 mm Hg, and 10.3/8.2 mm Hg, respectively, while those in the standard HCTZ arm saw drops of 6.0/4.2 mm Hg (J Am Coll Cardiol. 2016 Jan 25;67:379-89).
Also at 12 weeks, the chlorthalidone and HCTZ-CR groups had mean nocturnal systolic pressure decreases of 10.2 and 12.7 mm/Hg, respectively, while those receiving standard HCTZ saw nighttime SBP reduced by mean 4.9 mm Hg.
Low potassium was seen in 10% (n = 2) of patients taking HCTZ-CR, 5.6% of patients on standard HCTZ, and 6.3% (n = 1) of patients on chlorthalidone.
Dr. Pareek and his colleagues noted that chlorthalidone possesses a distinct pharmacokinetic profile from HCTZ, with a higher potency that allows it to be used as monotherapy in smaller doses and has “a wider volume of distribution, with partitioning into red blood cells” that may be responsible for its longer duration of action.
Dr. Pareek and his colleagues wrote that previous studies have shown an overestimation of the response to standard HCTZ, based on office blood pressure measurements alone.
“Assessing the antihypertensive efficacy of HCTZ by [office] BP measurements only is deceptive and prone to lull physicians and patients into a false sense of security,” the researchers wrote. “With HCTZ therapy, sustained hypertension merely will be converted into masked hypertension.”
Low-dose chlorthalidone can be used as monotherapy in treating essential hypertension, Dr. Pareek and his colleagues concluded, whereas standard low-dose HCTZ should no longer be considered an acceptable option.
The investigators noted as a limitation of their study its small size.
Ipca Laboratories, a manufacturer of chlorthalidone, sponsored the study, whose lead author and two coauthors are also employees of Ipca.
FROM JACC
Key clinical point: Standard HCTZ 12.5 mg did not significantly lower blood pressure over 24 hours, while 6.25 mg chlorthalidone and 12.5 mg controlled-release HCTZ did.
Major finding: At 12 weeks, patients treated with chlorthalidone or HCTZ-CR achieved reductions of 11.1/7.8 mm Hg and 10.3/8.2 mm Hg (P less than .01 for both), respectively, while those in the standard HCTZ arm saw drops of 6.0/4.2 mm Hg.
Data source: A randomized, double-blind, comparative study enrolling 54 patients with stage 1 hypertension. Patients were randomized to receive chlorthalidone 6.25 mg, HCTZ-CR 12.5 mg, or conventional HCTZ 12.5 mg and were followed up at 4 and 12 weeks with ambulatory and in-office BP monitoring.
Disclosures: The study was sponsored by a manufacturer of chlorthalidone, with lead author and two coauthors who are company employees.
