Three generations of a family

 

A new study suggests mutations in the gene DDX41 occur in families where hematologic malignancies are common.

Previous research showed that both germline and acquired DDX41 mutations occur in families with multiple cases of late-onset myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

The new study, published in Blood, has linked germline mutations in DDX41 to chronic myeloid leukemia and lymphomas as well.

“This is the first gene identified in families with lymphoma and represents a major breakthrough for the field,” said study author Hamish Scott, PhD, of the University of Adelaide in South Australia.

“Researchers are recognizing now that genetic predisposition to blood cancer is more common than previously thought, and our study shows the importance of taking a thorough family history at diagnosis.”

To conduct this study, Dr Scott and his colleagues screened 2 cohorts of families with a range of hematologic disorders (malignant and non-malignant). One cohort included 240 individuals from 93 families in Australia. The other included 246 individuals from 198 families in the US.

In all, 9 of the families (3%) had germline DDX41 mutations.

Three families carried the recurrent p.D140Gfs*2 mutation, which was linked to AML.

One family carried a germline mutation—p.R525H, c.1574G.A—that was previously described only as a somatic mutation at the time of progression to MDS or AML. In the current study, the mutation was again linked to MDS and AML.

Five families carried novel DDX41 mutations.

One of these mutations was a germline substitution—c.435-2_435-1delAGinsCA—that was linked to MDS in 1 family.

Two families had a missense start-loss substitution—c.3G.A, p.M1I—that was linked to MDS, AML, chronic myeloid leukemia, and non-Hodgkin lymphoma.

One family had a DDX41 missense variant—c.490C.T, p.R164W. This was linked to Hodgkin and non-Hodgkin lymphoma (including 3 cases of follicular lymphoma). There was a possible link to multiple myeloma as well, but the diagnosis could not be confirmed.

And 1 family had a missense mutation in the helicase domain—p.G530D—that was linked to AML.

“DDX41 is a new type of cancer predisposition gene, and we are still investigating its function,” Dr Scott noted.

“But it appears to have dual roles in regulating the correct expression of genes in the cell and also enabling the immune system to respond to threats such as bacteria and viruses, as well as the development of cancer cells. Immunotherapy is a promising approach for cancer treatment, and our research to understand the function of DDX41 will help design better therapies.”

 

 

Three generations of a family

 

A new study suggests mutations in the gene DDX41 occur in families where hematologic malignancies are common.

Previous research showed that both germline and acquired DDX41 mutations occur in families with multiple cases of late-onset myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

The new study, published in Blood, has linked germline mutations in DDX41 to chronic myeloid leukemia and lymphomas as well.

“This is the first gene identified in families with lymphoma and represents a major breakthrough for the field,” said study author Hamish Scott, PhD, of the University of Adelaide in South Australia.

“Researchers are recognizing now that genetic predisposition to blood cancer is more common than previously thought, and our study shows the importance of taking a thorough family history at diagnosis.”

To conduct this study, Dr Scott and his colleagues screened 2 cohorts of families with a range of hematologic disorders (malignant and non-malignant). One cohort included 240 individuals from 93 families in Australia. The other included 246 individuals from 198 families in the US.

In all, 9 of the families (3%) had germline DDX41 mutations.

Three families carried the recurrent p.D140Gfs*2 mutation, which was linked to AML.

One family carried a germline mutation—p.R525H, c.1574G.A—that was previously described only as a somatic mutation at the time of progression to MDS or AML. In the current study, the mutation was again linked to MDS and AML.

Five families carried novel DDX41 mutations.

One of these mutations was a germline substitution—c.435-2_435-1delAGinsCA—that was linked to MDS in 1 family.

Two families had a missense start-loss substitution—c.3G.A, p.M1I—that was linked to MDS, AML, chronic myeloid leukemia, and non-Hodgkin lymphoma.

One family had a DDX41 missense variant—c.490C.T, p.R164W. This was linked to Hodgkin and non-Hodgkin lymphoma (including 3 cases of follicular lymphoma). There was a possible link to multiple myeloma as well, but the diagnosis could not be confirmed.

And 1 family had a missense mutation in the helicase domain—p.G530D—that was linked to AML.

“DDX41 is a new type of cancer predisposition gene, and we are still investigating its function,” Dr Scott noted.

“But it appears to have dual roles in regulating the correct expression of genes in the cell and also enabling the immune system to respond to threats such as bacteria and viruses, as well as the development of cancer cells. Immunotherapy is a promising approach for cancer treatment, and our research to understand the function of DDX41 will help design better therapies.”

 

 

Three generations of a family

 

A new study suggests mutations in the gene DDX41 occur in families where hematologic malignancies are common.

Previous research showed that both germline and acquired DDX41 mutations occur in families with multiple cases of late-onset myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

The new study, published in Blood, has linked germline mutations in DDX41 to chronic myeloid leukemia and lymphomas as well.

“This is the first gene identified in families with lymphoma and represents a major breakthrough for the field,” said study author Hamish Scott, PhD, of the University of Adelaide in South Australia.

“Researchers are recognizing now that genetic predisposition to blood cancer is more common than previously thought, and our study shows the importance of taking a thorough family history at diagnosis.”

To conduct this study, Dr Scott and his colleagues screened 2 cohorts of families with a range of hematologic disorders (malignant and non-malignant). One cohort included 240 individuals from 93 families in Australia. The other included 246 individuals from 198 families in the US.

In all, 9 of the families (3%) had germline DDX41 mutations.

Three families carried the recurrent p.D140Gfs*2 mutation, which was linked to AML.

One family carried a germline mutation—p.R525H, c.1574G.A—that was previously described only as a somatic mutation at the time of progression to MDS or AML. In the current study, the mutation was again linked to MDS and AML.

Five families carried novel DDX41 mutations.

One of these mutations was a germline substitution—c.435-2_435-1delAGinsCA—that was linked to MDS in 1 family.

Two families had a missense start-loss substitution—c.3G.A, p.M1I—that was linked to MDS, AML, chronic myeloid leukemia, and non-Hodgkin lymphoma.

One family had a DDX41 missense variant—c.490C.T, p.R164W. This was linked to Hodgkin and non-Hodgkin lymphoma (including 3 cases of follicular lymphoma). There was a possible link to multiple myeloma as well, but the diagnosis could not be confirmed.

And 1 family had a missense mutation in the helicase domain—p.G530D—that was linked to AML.

“DDX41 is a new type of cancer predisposition gene, and we are still investigating its function,” Dr Scott noted.

“But it appears to have dual roles in regulating the correct expression of genes in the cell and also enabling the immune system to respond to threats such as bacteria and viruses, as well as the development of cancer cells. Immunotherapy is a promising approach for cancer treatment, and our research to understand the function of DDX41 will help design better therapies.”

Warfarin tablets

Results of a large study suggest warfarin may pose a higher risk of traumatic intracranial bleeding than previously reported, at least among older patients with atrial fibrillation (AF).

The study included more than 30,000 US veterans with AF who were 75 years or older when starting warfarin.

These patients had a higher rate of traumatic intracranial bleeding than reported in previous trials.

John A. Dodson, MD, of the New York University School of Medicine in New York, New York, and his colleagues conducted this research and reported the results in JAMA Cardiology.

The researchers studied 31,951 subjects with AF who were 75 years or older and were new referrals to Veterans Affairs anticoagulation clinics for warfarin therapy between January 1, 2002, and December 31, 2012.

The patients had a mean age of 81.1, and 98.1% were male. Comorbidities included hypertension (82.5%), coronary artery disease (42.6%), and diabetes mellitus (33.8%).

The researchers found the incidence rate of hospitalization for any intracranial bleeding among these patients was 14.58 per 1000 person-years.

And the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1000 person-years.

The researchers said this was “considerably higher” than reported in two previous trials, one published in The Lancet in 1996 and one published in JAMA Internal Medicine in 1998.

Dr Dodson and his colleagues also looked at factors associated with traumatic intracranial bleeding in their patient population.

In unadjusted analyses, the following factors were significant predictors of traumatic intracranial bleeding: dementia, fall within the past year, anemia, depression, abnormal renal or liver function, anticonvulsant use, labile international normalized ratio, and antihypertensive use.

However, when the researchers adjusted their analyses for potential confounders, fewer factors remained significant predictors. These were dementia (hazard ratio [HR]=1.76), anemia (HR=1.23), depression (HR=1.30), anticonvulsant use (HR=1.35), and labile international normalized ratio (HR=1.33).

The researchers noted that risk factors for traumatic intracranial bleeding were different from risk factors for ischemic stroke.

They also said the high overall rate of intracranial bleeding in this study suggests a need to more systematically evaluate the benefits and harms of warfarin in older adults.

Warfarin tablets

Results of a large study suggest warfarin may pose a higher risk of traumatic intracranial bleeding than previously reported, at least among older patients with atrial fibrillation (AF).

The study included more than 30,000 US veterans with AF who were 75 years or older when starting warfarin.

These patients had a higher rate of traumatic intracranial bleeding than reported in previous trials.

John A. Dodson, MD, of the New York University School of Medicine in New York, New York, and his colleagues conducted this research and reported the results in JAMA Cardiology.

The researchers studied 31,951 subjects with AF who were 75 years or older and were new referrals to Veterans Affairs anticoagulation clinics for warfarin therapy between January 1, 2002, and December 31, 2012.

The patients had a mean age of 81.1, and 98.1% were male. Comorbidities included hypertension (82.5%), coronary artery disease (42.6%), and diabetes mellitus (33.8%).

The researchers found the incidence rate of hospitalization for any intracranial bleeding among these patients was 14.58 per 1000 person-years.

And the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1000 person-years.

The researchers said this was “considerably higher” than reported in two previous trials, one published in The Lancet in 1996 and one published in JAMA Internal Medicine in 1998.

Dr Dodson and his colleagues also looked at factors associated with traumatic intracranial bleeding in their patient population.

In unadjusted analyses, the following factors were significant predictors of traumatic intracranial bleeding: dementia, fall within the past year, anemia, depression, abnormal renal or liver function, anticonvulsant use, labile international normalized ratio, and antihypertensive use.

However, when the researchers adjusted their analyses for potential confounders, fewer factors remained significant predictors. These were dementia (hazard ratio [HR]=1.76), anemia (HR=1.23), depression (HR=1.30), anticonvulsant use (HR=1.35), and labile international normalized ratio (HR=1.33).

The researchers noted that risk factors for traumatic intracranial bleeding were different from risk factors for ischemic stroke.

They also said the high overall rate of intracranial bleeding in this study suggests a need to more systematically evaluate the benefits and harms of warfarin in older adults.

Warfarin tablets

Results of a large study suggest warfarin may pose a higher risk of traumatic intracranial bleeding than previously reported, at least among older patients with atrial fibrillation (AF).

The study included more than 30,000 US veterans with AF who were 75 years or older when starting warfarin.

These patients had a higher rate of traumatic intracranial bleeding than reported in previous trials.

John A. Dodson, MD, of the New York University School of Medicine in New York, New York, and his colleagues conducted this research and reported the results in JAMA Cardiology.

The researchers studied 31,951 subjects with AF who were 75 years or older and were new referrals to Veterans Affairs anticoagulation clinics for warfarin therapy between January 1, 2002, and December 31, 2012.

The patients had a mean age of 81.1, and 98.1% were male. Comorbidities included hypertension (82.5%), coronary artery disease (42.6%), and diabetes mellitus (33.8%).

The researchers found the incidence rate of hospitalization for any intracranial bleeding among these patients was 14.58 per 1000 person-years.

And the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1000 person-years.

The researchers said this was “considerably higher” than reported in two previous trials, one published in The Lancet in 1996 and one published in JAMA Internal Medicine in 1998.

Dr Dodson and his colleagues also looked at factors associated with traumatic intracranial bleeding in their patient population.

In unadjusted analyses, the following factors were significant predictors of traumatic intracranial bleeding: dementia, fall within the past year, anemia, depression, abnormal renal or liver function, anticonvulsant use, labile international normalized ratio, and antihypertensive use.

However, when the researchers adjusted their analyses for potential confounders, fewer factors remained significant predictors. These were dementia (hazard ratio [HR]=1.76), anemia (HR=1.23), depression (HR=1.30), anticonvulsant use (HR=1.35), and labile international normalized ratio (HR=1.33).

The researchers noted that risk factors for traumatic intracranial bleeding were different from risk factors for ischemic stroke.

They also said the high overall rate of intracranial bleeding in this study suggests a need to more systematically evaluate the benefits and harms of warfarin in older adults.

Micrograph showing DLBCL

The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for pidilizumab (MDV9300) in hematologic malignancies.

This means the phase 2 trial of pidilizumab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as other studies that cross-reference the IND for the drug, may now proceed.

The partial clinical hold on pidilizumab was not related to any safety concerns.

The FDA placed the hold because the company developing pidilizumab, Medivation Inc., determined that the drug is not an inhibitor of PD-1, as researchers previously thought.

The phase 2 trial of pidilizumab in DLBCL was launched in late 2015 but had not enrolled any patients before the FDA placed the partial clinical hold.

Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment despite the hold, and those investigators have been told to update their protocols and informed consent documents to reflect that pidilizumab is not an anti-PD-1 antibody.

Medivation has likewise revised the investigator brochure, protocols, and informed consent documents related to the phase 2 trial of DLBCL patients.

The company said it is still trying to determine pidilizumab’s mechanism of action.

“We are delighted that the FDA has lifted the partial clinical hold and that we may proceed with our potentially pivotal trial in this area of high unmet medical need,” said David Hung, MD, founder, president, and chief executive officer of Medivation.

“As we move forward, we also are working to determine the compound’s exact binding mechanism which, we believe, modulates the body’s innate immune response and differentiates it from the heavily crowded immuno-oncology space that targets the adaptive side of immunity.”

Medivation said it intends to submit an amendment to the Chemistry, Manufacturing, and Controls section of the IND for pidilizumab to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for the drug.

The company also said it plans to resume the phase 2 trial of pidilizumab in DLBLCL in the second half of this year.

The trial is expected to enroll approximately 180 patients who had an incomplete response to salvage therapy or autologous stem cell transplant for relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma, or primary mediastinal B-cell lymphoma.

The patients will be assessed in 2 parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the other will enroll patients who have received salvage chemotherapy but are ineligible for transplant.

Pidilizumab will be given at a dose of 200 mg by intravenous infusion. The primary endpoint of the trial is best overall response rate.

Micrograph showing DLBCL

The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for pidilizumab (MDV9300) in hematologic malignancies.

This means the phase 2 trial of pidilizumab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as other studies that cross-reference the IND for the drug, may now proceed.

The partial clinical hold on pidilizumab was not related to any safety concerns.

The FDA placed the hold because the company developing pidilizumab, Medivation Inc., determined that the drug is not an inhibitor of PD-1, as researchers previously thought.

The phase 2 trial of pidilizumab in DLBCL was launched in late 2015 but had not enrolled any patients before the FDA placed the partial clinical hold.

Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment despite the hold, and those investigators have been told to update their protocols and informed consent documents to reflect that pidilizumab is not an anti-PD-1 antibody.

Medivation has likewise revised the investigator brochure, protocols, and informed consent documents related to the phase 2 trial of DLBCL patients.

The company said it is still trying to determine pidilizumab’s mechanism of action.

“We are delighted that the FDA has lifted the partial clinical hold and that we may proceed with our potentially pivotal trial in this area of high unmet medical need,” said David Hung, MD, founder, president, and chief executive officer of Medivation.

“As we move forward, we also are working to determine the compound’s exact binding mechanism which, we believe, modulates the body’s innate immune response and differentiates it from the heavily crowded immuno-oncology space that targets the adaptive side of immunity.”

Medivation said it intends to submit an amendment to the Chemistry, Manufacturing, and Controls section of the IND for pidilizumab to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for the drug.

The company also said it plans to resume the phase 2 trial of pidilizumab in DLBLCL in the second half of this year.

The trial is expected to enroll approximately 180 patients who had an incomplete response to salvage therapy or autologous stem cell transplant for relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma, or primary mediastinal B-cell lymphoma.

The patients will be assessed in 2 parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the other will enroll patients who have received salvage chemotherapy but are ineligible for transplant.

Pidilizumab will be given at a dose of 200 mg by intravenous infusion. The primary endpoint of the trial is best overall response rate.

Micrograph showing DLBCL

The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for pidilizumab (MDV9300) in hematologic malignancies.

This means the phase 2 trial of pidilizumab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as other studies that cross-reference the IND for the drug, may now proceed.

The partial clinical hold on pidilizumab was not related to any safety concerns.

The FDA placed the hold because the company developing pidilizumab, Medivation Inc., determined that the drug is not an inhibitor of PD-1, as researchers previously thought.

The phase 2 trial of pidilizumab in DLBCL was launched in late 2015 but had not enrolled any patients before the FDA placed the partial clinical hold.

Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment despite the hold, and those investigators have been told to update their protocols and informed consent documents to reflect that pidilizumab is not an anti-PD-1 antibody.

Medivation has likewise revised the investigator brochure, protocols, and informed consent documents related to the phase 2 trial of DLBCL patients.

The company said it is still trying to determine pidilizumab’s mechanism of action.

“We are delighted that the FDA has lifted the partial clinical hold and that we may proceed with our potentially pivotal trial in this area of high unmet medical need,” said David Hung, MD, founder, president, and chief executive officer of Medivation.

“As we move forward, we also are working to determine the compound’s exact binding mechanism which, we believe, modulates the body’s innate immune response and differentiates it from the heavily crowded immuno-oncology space that targets the adaptive side of immunity.”

Medivation said it intends to submit an amendment to the Chemistry, Manufacturing, and Controls section of the IND for pidilizumab to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for the drug.

The company also said it plans to resume the phase 2 trial of pidilizumab in DLBLCL in the second half of this year.

The trial is expected to enroll approximately 180 patients who had an incomplete response to salvage therapy or autologous stem cell transplant for relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma, or primary mediastinal B-cell lymphoma.

The patients will be assessed in 2 parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the other will enroll patients who have received salvage chemotherapy but are ineligible for transplant.

Pidilizumab will be given at a dose of 200 mg by intravenous infusion. The primary endpoint of the trial is best overall response rate.

Surgeons at the Cleveland Clinic had to remove the transplanted uterus of a 26-year-old woman who was the first patient in a groundbreaking U.S.-based study aimed at achieving pregnancy in women with uterine factor infertility.

Removal of the uterus, which was announced March 9, came after the patient experienced a sudden complication. The study was originally slated to include 10 women and is still ongoing, according to a statement from the Cleveland Clinic.

Courtesy of the Cleveland Clinic

“At this time, the circumstance of the complication is under review and more information will be shared as it becomes available,” according to a statement. “There is a known risk in solid organ transplantation that the transplanted organ may have to be removed should a complication arise. The medical team took all necessary precautions and measures to ensure the safety of our patient.”

On Feb. 24, a transplant team at the Cleveland Clinic made history by performing the first uterus transplant in the United States. Prior to that, there had been nine successful uterus transplants performed at the University of Gothenburg in Sweden, with the first posttransplant baby born in 2014.

The Cleveland Clinic transplant recipient, known as “Lindsey” to protect her privacy, was selected from more than 250 applicants to undergo the 9-hour procedure involving transplantation of a uterus from a deceased organ donor of reproductive age.

If the transplant had been a successful, Lindsey was set to undergo a year of antirejection treatment followed by in vitro fertilization. Under the study protocol, the uterus transplant would be temporary and the uterus would be removed after a patient had delivered one or two babies.

Officials at the Cleveland Clinic said Lindsey was doing well and recovering after the removal of the transplanted uterus.

“I just wanted to take a moment to express my gratitude toward all of my doctors,” Lindsey and her husband said in a statement. “They acted very quickly to ensure my health and safety. Unfortunately, I did lose the uterus to complications. However, I am doing okay and appreciate all of your prayers and good thoughts.”

[email protected]

On Twitter @maryellenny

Surgeons at the Cleveland Clinic had to remove the transplanted uterus of a 26-year-old woman who was the first patient in a groundbreaking U.S.-based study aimed at achieving pregnancy in women with uterine factor infertility.

Removal of the uterus, which was announced March 9, came after the patient experienced a sudden complication. The study was originally slated to include 10 women and is still ongoing, according to a statement from the Cleveland Clinic.

Courtesy of the Cleveland Clinic

“At this time, the circumstance of the complication is under review and more information will be shared as it becomes available,” according to a statement. “There is a known risk in solid organ transplantation that the transplanted organ may have to be removed should a complication arise. The medical team took all necessary precautions and measures to ensure the safety of our patient.”

On Feb. 24, a transplant team at the Cleveland Clinic made history by performing the first uterus transplant in the United States. Prior to that, there had been nine successful uterus transplants performed at the University of Gothenburg in Sweden, with the first posttransplant baby born in 2014.

The Cleveland Clinic transplant recipient, known as “Lindsey” to protect her privacy, was selected from more than 250 applicants to undergo the 9-hour procedure involving transplantation of a uterus from a deceased organ donor of reproductive age.

If the transplant had been a successful, Lindsey was set to undergo a year of antirejection treatment followed by in vitro fertilization. Under the study protocol, the uterus transplant would be temporary and the uterus would be removed after a patient had delivered one or two babies.

Officials at the Cleveland Clinic said Lindsey was doing well and recovering after the removal of the transplanted uterus.

“I just wanted to take a moment to express my gratitude toward all of my doctors,” Lindsey and her husband said in a statement. “They acted very quickly to ensure my health and safety. Unfortunately, I did lose the uterus to complications. However, I am doing okay and appreciate all of your prayers and good thoughts.”

[email protected]

On Twitter @maryellenny

Surgeons at the Cleveland Clinic had to remove the transplanted uterus of a 26-year-old woman who was the first patient in a groundbreaking U.S.-based study aimed at achieving pregnancy in women with uterine factor infertility.

Removal of the uterus, which was announced March 9, came after the patient experienced a sudden complication. The study was originally slated to include 10 women and is still ongoing, according to a statement from the Cleveland Clinic.

Courtesy of the Cleveland Clinic

“At this time, the circumstance of the complication is under review and more information will be shared as it becomes available,” according to a statement. “There is a known risk in solid organ transplantation that the transplanted organ may have to be removed should a complication arise. The medical team took all necessary precautions and measures to ensure the safety of our patient.”

On Feb. 24, a transplant team at the Cleveland Clinic made history by performing the first uterus transplant in the United States. Prior to that, there had been nine successful uterus transplants performed at the University of Gothenburg in Sweden, with the first posttransplant baby born in 2014.

The Cleveland Clinic transplant recipient, known as “Lindsey” to protect her privacy, was selected from more than 250 applicants to undergo the 9-hour procedure involving transplantation of a uterus from a deceased organ donor of reproductive age.

If the transplant had been a successful, Lindsey was set to undergo a year of antirejection treatment followed by in vitro fertilization. Under the study protocol, the uterus transplant would be temporary and the uterus would be removed after a patient had delivered one or two babies.

Officials at the Cleveland Clinic said Lindsey was doing well and recovering after the removal of the transplanted uterus.

“I just wanted to take a moment to express my gratitude toward all of my doctors,” Lindsey and her husband said in a statement. “They acted very quickly to ensure my health and safety. Unfortunately, I did lose the uterus to complications. However, I am doing okay and appreciate all of your prayers and good thoughts.”

[email protected]

On Twitter @maryellenny

SCOTTSDALE, ARIZ. – Patients with head and neck cancer have substantial disparities in presentation, treatment, and outcomes according to their health insurance status, suggest results of a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

The analysis of more than 50,000 patients from the Surveillance, Epidemiology, and End Results (SEER) registry found that relative to counterparts with insurance, those with Medicaid or no insurance had more advanced disease at presentation.

Additionally, the Medicaid and uninsured patients were 23% and 32% less likely, respectively, to receive radiation therapy, and the uninsured were 23% less to receive surgery, according to data reported in a session and related press briefing.

Both overall and cancer-specific survival were worse for these two groups as well. And when compared with each other, the Medicaid patients actually had poorer overall survival than the uninsured, and similar cause-specific survival.

“We noted important disparities among Medicaid and uninsured cancer patients with head and neck malignancies in the United States,” said lead author Dr. Thomas M. Churilla of the Fox Chase Cancer Center in Philadelphia. “We hypothesize that lack of access to primary care and dental providers may be one of the reasons why patients are presenting with more locally advanced disease.”

The Patient Protection and Affordable Care Act aims to address lack of insurance in part by expanding Medicaid, he noted. However, “given the excess in cancer mortality seen in the Medicaid group and striking similarity with the uninsured group, expansions in Medicaid may have limited effect on outcomes among head and neck cancer patients without further study into figuring out which patient, provider, and health care system factors may be underlying these differences.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, asked, “In your data set, do you have any information on the length of insurance coverage? We see a fair number of patients who come in with no insurance but ultimately get enrolled in Medicaid. Would they have been included in the Medicaid group or the insured group in this study?”

The SEER database does not provide that information, Dr. Churilla said. “The inability to tell the length of insurance coverage is an important limitation of our study, and it may limit our inferences to tell the difference between these two groups,” he acknowledged, adding that the database also lacks information about other important potential confounders, including systemic therapies; risk factors such as smoking, alcohol intake, and human papillomavirus status; and the size, type, and experience of the treating center.

A session attendee said, “You showed that uninsured patients did better than Medicaid patients. Is this possibly due to the uninsured getting free care rather than [clinicians] needing to follow Medicaid-approved treatment?”

“We are scratching our heads a little bit with this one as well, but I think some of the difference may be due in part to the age differences,” Dr. Churilla replied. “The Medicaid patients on average were older than uninsured patients, so perhaps more competing causes of death leading to a difference in overall survival yet similar cancer-specific survival.”

For the study, the investigators analyzed outcomes among 53,848 patients who had primary squamous cell carcinoma of the oral cavity, pharynx, or larynx diagnosed during 2007-2012. Overall, 80% were insured (through private insurance or Medicare), 15% had Medicaid, and 5% were uninsured.

Results showed that patients with Medicaid or no insurance had more advanced cancer at presentation than insured peers. For example, 56% and 59% of patients with Medicaid and no insurance, respectively, had stage 4 disease, compared with 43% of insured patients.

In multivariate analyses adjusted for socioeconomic characteristics, clinical factors (including stage), and treatments, the likelihood of receiving external-beam radiation therapy was lower for the Medicaid group (hazard ratio, 0.77; P less than .001) and the uninsured group (HR, 0.68; P less than .001). Additionally, the uninsured were less likely to receive cancer-directed surgery, defined as at least a wide local excision (HR, 0.77; P less than .001).

In addition, both Medicaid and uninsured patients had poorer overall survival (HRs, 1.54 and 1.49) and cancer-specific survival (HRs, 1.59 and 1.66) relative to insured counterparts.

Findings were generally the same after propensity score weighting and in a sensitivity analysis that excluded all patients aged 65 or older because of their Medicare eligibility.

Addressing the observed disparities for the uninsured patients will require action on both the clinician and policy levels, Dr. Churilla said.

“One of the first steps is awareness among both dental and medical communities and trying to provide social services and financial counseling to help these patients enroll in certain programs such as Medicaid that they may be eligible for,” he elaborated. “And then I think the rest of it really lies with national policy – how do we expand coverage to help get these people the health care that they need and the appropriate services that they require.”

SCOTTSDALE, ARIZ. – Patients with head and neck cancer have substantial disparities in presentation, treatment, and outcomes according to their health insurance status, suggest results of a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

The analysis of more than 50,000 patients from the Surveillance, Epidemiology, and End Results (SEER) registry found that relative to counterparts with insurance, those with Medicaid or no insurance had more advanced disease at presentation.

Additionally, the Medicaid and uninsured patients were 23% and 32% less likely, respectively, to receive radiation therapy, and the uninsured were 23% less to receive surgery, according to data reported in a session and related press briefing.

Both overall and cancer-specific survival were worse for these two groups as well. And when compared with each other, the Medicaid patients actually had poorer overall survival than the uninsured, and similar cause-specific survival.

“We noted important disparities among Medicaid and uninsured cancer patients with head and neck malignancies in the United States,” said lead author Dr. Thomas M. Churilla of the Fox Chase Cancer Center in Philadelphia. “We hypothesize that lack of access to primary care and dental providers may be one of the reasons why patients are presenting with more locally advanced disease.”

The Patient Protection and Affordable Care Act aims to address lack of insurance in part by expanding Medicaid, he noted. However, “given the excess in cancer mortality seen in the Medicaid group and striking similarity with the uninsured group, expansions in Medicaid may have limited effect on outcomes among head and neck cancer patients without further study into figuring out which patient, provider, and health care system factors may be underlying these differences.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, asked, “In your data set, do you have any information on the length of insurance coverage? We see a fair number of patients who come in with no insurance but ultimately get enrolled in Medicaid. Would they have been included in the Medicaid group or the insured group in this study?”

The SEER database does not provide that information, Dr. Churilla said. “The inability to tell the length of insurance coverage is an important limitation of our study, and it may limit our inferences to tell the difference between these two groups,” he acknowledged, adding that the database also lacks information about other important potential confounders, including systemic therapies; risk factors such as smoking, alcohol intake, and human papillomavirus status; and the size, type, and experience of the treating center.

A session attendee said, “You showed that uninsured patients did better than Medicaid patients. Is this possibly due to the uninsured getting free care rather than [clinicians] needing to follow Medicaid-approved treatment?”

“We are scratching our heads a little bit with this one as well, but I think some of the difference may be due in part to the age differences,” Dr. Churilla replied. “The Medicaid patients on average were older than uninsured patients, so perhaps more competing causes of death leading to a difference in overall survival yet similar cancer-specific survival.”

For the study, the investigators analyzed outcomes among 53,848 patients who had primary squamous cell carcinoma of the oral cavity, pharynx, or larynx diagnosed during 2007-2012. Overall, 80% were insured (through private insurance or Medicare), 15% had Medicaid, and 5% were uninsured.

Results showed that patients with Medicaid or no insurance had more advanced cancer at presentation than insured peers. For example, 56% and 59% of patients with Medicaid and no insurance, respectively, had stage 4 disease, compared with 43% of insured patients.

In multivariate analyses adjusted for socioeconomic characteristics, clinical factors (including stage), and treatments, the likelihood of receiving external-beam radiation therapy was lower for the Medicaid group (hazard ratio, 0.77; P less than .001) and the uninsured group (HR, 0.68; P less than .001). Additionally, the uninsured were less likely to receive cancer-directed surgery, defined as at least a wide local excision (HR, 0.77; P less than .001).

In addition, both Medicaid and uninsured patients had poorer overall survival (HRs, 1.54 and 1.49) and cancer-specific survival (HRs, 1.59 and 1.66) relative to insured counterparts.

Findings were generally the same after propensity score weighting and in a sensitivity analysis that excluded all patients aged 65 or older because of their Medicare eligibility.

Addressing the observed disparities for the uninsured patients will require action on both the clinician and policy levels, Dr. Churilla said.

“One of the first steps is awareness among both dental and medical communities and trying to provide social services and financial counseling to help these patients enroll in certain programs such as Medicaid that they may be eligible for,” he elaborated. “And then I think the rest of it really lies with national policy – how do we expand coverage to help get these people the health care that they need and the appropriate services that they require.”

SCOTTSDALE, ARIZ. – Patients with head and neck cancer have substantial disparities in presentation, treatment, and outcomes according to their health insurance status, suggest results of a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

The analysis of more than 50,000 patients from the Surveillance, Epidemiology, and End Results (SEER) registry found that relative to counterparts with insurance, those with Medicaid or no insurance had more advanced disease at presentation.

Additionally, the Medicaid and uninsured patients were 23% and 32% less likely, respectively, to receive radiation therapy, and the uninsured were 23% less to receive surgery, according to data reported in a session and related press briefing.

Both overall and cancer-specific survival were worse for these two groups as well. And when compared with each other, the Medicaid patients actually had poorer overall survival than the uninsured, and similar cause-specific survival.

“We noted important disparities among Medicaid and uninsured cancer patients with head and neck malignancies in the United States,” said lead author Dr. Thomas M. Churilla of the Fox Chase Cancer Center in Philadelphia. “We hypothesize that lack of access to primary care and dental providers may be one of the reasons why patients are presenting with more locally advanced disease.”

The Patient Protection and Affordable Care Act aims to address lack of insurance in part by expanding Medicaid, he noted. However, “given the excess in cancer mortality seen in the Medicaid group and striking similarity with the uninsured group, expansions in Medicaid may have limited effect on outcomes among head and neck cancer patients without further study into figuring out which patient, provider, and health care system factors may be underlying these differences.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, asked, “In your data set, do you have any information on the length of insurance coverage? We see a fair number of patients who come in with no insurance but ultimately get enrolled in Medicaid. Would they have been included in the Medicaid group or the insured group in this study?”

The SEER database does not provide that information, Dr. Churilla said. “The inability to tell the length of insurance coverage is an important limitation of our study, and it may limit our inferences to tell the difference between these two groups,” he acknowledged, adding that the database also lacks information about other important potential confounders, including systemic therapies; risk factors such as smoking, alcohol intake, and human papillomavirus status; and the size, type, and experience of the treating center.

A session attendee said, “You showed that uninsured patients did better than Medicaid patients. Is this possibly due to the uninsured getting free care rather than [clinicians] needing to follow Medicaid-approved treatment?”

“We are scratching our heads a little bit with this one as well, but I think some of the difference may be due in part to the age differences,” Dr. Churilla replied. “The Medicaid patients on average were older than uninsured patients, so perhaps more competing causes of death leading to a difference in overall survival yet similar cancer-specific survival.”

For the study, the investigators analyzed outcomes among 53,848 patients who had primary squamous cell carcinoma of the oral cavity, pharynx, or larynx diagnosed during 2007-2012. Overall, 80% were insured (through private insurance or Medicare), 15% had Medicaid, and 5% were uninsured.

Results showed that patients with Medicaid or no insurance had more advanced cancer at presentation than insured peers. For example, 56% and 59% of patients with Medicaid and no insurance, respectively, had stage 4 disease, compared with 43% of insured patients.

In multivariate analyses adjusted for socioeconomic characteristics, clinical factors (including stage), and treatments, the likelihood of receiving external-beam radiation therapy was lower for the Medicaid group (hazard ratio, 0.77; P less than .001) and the uninsured group (HR, 0.68; P less than .001). Additionally, the uninsured were less likely to receive cancer-directed surgery, defined as at least a wide local excision (HR, 0.77; P less than .001).

In addition, both Medicaid and uninsured patients had poorer overall survival (HRs, 1.54 and 1.49) and cancer-specific survival (HRs, 1.59 and 1.66) relative to insured counterparts.

Findings were generally the same after propensity score weighting and in a sensitivity analysis that excluded all patients aged 65 or older because of their Medicare eligibility.

Addressing the observed disparities for the uninsured patients will require action on both the clinician and policy levels, Dr. Churilla said.

“One of the first steps is awareness among both dental and medical communities and trying to provide social services and financial counseling to help these patients enroll in certain programs such as Medicaid that they may be eligible for,” he elaborated. “And then I think the rest of it really lies with national policy – how do we expand coverage to help get these people the health care that they need and the appropriate services that they require.”

WAIKOLOA, HAWAII – Two recent studies highlight several key points regarding topical therapy for onychomycosis: Treat it early for best results, and if concomitant tinea pedis is present, be sure to treat that, too, Dr. Theodore Rosen said at the Hawaii Dermatology Seminar.

The studies were separate secondary analyses of the pooled results of two large, double blind, vehicle-controlled, 48-week, phase III randomized trials of efinaconazole 10% topical solution (Jublia) for onychomycosis. But the same lessons probably apply to any topical antifungal, according to Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

Early treatment: This makes a big difference in outcome, as demonstrated in Dr. Phoebe Rich’s analysis of 1,655 patients in the phase III studies. Dr. Rich, director of the nail disorders clinic at Oregon Health and Science University, Portland, divided participants into three groups based upon disease duration: less than a year, 1-5 years, or more than 5 years. The complete cure rate was much better in the group with less than 1 year of onychomycosis, even though the extent of nail involvement of the target toenail didn’t differ significantly between the three groups (J Drugs Dermatol. 2015;Jan 14[1]:58-62).

“Now we have data: Don’t wait to treat until it has been there for 35 years. It’s easier to treat if it’s early,” Dr. Rosen commented at the seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

When onychomycosis and tinea pedis coexist, treat both: Dr. Leon H. Kircik of Indiana University, Indianapolis, and associates reported in a poster at the Hawaii Dermatology Seminar that one in five participants in the two phase III trials had tinea pedis as well as onychomycosis, and nearly half of them were treated for their athlete’s foot using their physician’s choice of topical antifungals.

The primary endpoint in the two trials was the week 53 complete cure rate, defined as no clinical involvement of the target toenail, a negative potassium hydroxide exam, and a negative fungal culture. Among subjects with concomitant onychomycosis and tinea pedis, the onychomycosis complete cure rate was 28.2% if they received efinaconazole for their onychomycosis and got treatment for their tinea pedis, compared with 20.9% if they got efinaconazole but no treatment for their tinea pedis. The complete/almost complete cure rate was 35.5% with dual therapy versus 29.6% if they only received efinaconazole. Both differences were significant.

“Doesn’t that make logical sense? If you leave the fungus on the foot or between the toes, it’s going to say, ‘Wow, that’s steak up there on the nail. That’s real food. I’m just going to crawl back onto the nail because all my brothers up there are dead and there’s wide-open space,” Dr. Rosen explained.

He added that the reverse is also true: if a patient presents seeking treatment for athlete’s foot but also has onychomycosis, the best treatment results for the tinea pedis are obtained by also treating the nail infection.

Dr. Rosen offered a money-saving tip for effective OTC therapy for tinea pedis. Two words: Lotrimin Ultra. That’s the brand name for butenafine cream 1%, not to be confused with plain old Lotrimin, which is clotrimazole.

“Clotrimazole has been around since the dawn of man, and it’s not very effective. Many of the fungi are actually resistant to it. But they’re not resistant to butenafine, which is a very good topical antifungal now available over the counter. It costs $9 or $10 dollars for a tube the size of a baseball bat. It’s a good, effective, cheap way of treating concomitant tinea pedis,” he said.

Dr. Rosen reported serving on scientific advisory boards for Anacor, Merz, and Valeant.

SDEF and this news organization are owned by the same parent company.

[email protected]

WAIKOLOA, HAWAII – Two recent studies highlight several key points regarding topical therapy for onychomycosis: Treat it early for best results, and if concomitant tinea pedis is present, be sure to treat that, too, Dr. Theodore Rosen said at the Hawaii Dermatology Seminar.

The studies were separate secondary analyses of the pooled results of two large, double blind, vehicle-controlled, 48-week, phase III randomized trials of efinaconazole 10% topical solution (Jublia) for onychomycosis. But the same lessons probably apply to any topical antifungal, according to Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

Early treatment: This makes a big difference in outcome, as demonstrated in Dr. Phoebe Rich’s analysis of 1,655 patients in the phase III studies. Dr. Rich, director of the nail disorders clinic at Oregon Health and Science University, Portland, divided participants into three groups based upon disease duration: less than a year, 1-5 years, or more than 5 years. The complete cure rate was much better in the group with less than 1 year of onychomycosis, even though the extent of nail involvement of the target toenail didn’t differ significantly between the three groups (J Drugs Dermatol. 2015;Jan 14[1]:58-62).

“Now we have data: Don’t wait to treat until it has been there for 35 years. It’s easier to treat if it’s early,” Dr. Rosen commented at the seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

When onychomycosis and tinea pedis coexist, treat both: Dr. Leon H. Kircik of Indiana University, Indianapolis, and associates reported in a poster at the Hawaii Dermatology Seminar that one in five participants in the two phase III trials had tinea pedis as well as onychomycosis, and nearly half of them were treated for their athlete’s foot using their physician’s choice of topical antifungals.

The primary endpoint in the two trials was the week 53 complete cure rate, defined as no clinical involvement of the target toenail, a negative potassium hydroxide exam, and a negative fungal culture. Among subjects with concomitant onychomycosis and tinea pedis, the onychomycosis complete cure rate was 28.2% if they received efinaconazole for their onychomycosis and got treatment for their tinea pedis, compared with 20.9% if they got efinaconazole but no treatment for their tinea pedis. The complete/almost complete cure rate was 35.5% with dual therapy versus 29.6% if they only received efinaconazole. Both differences were significant.

“Doesn’t that make logical sense? If you leave the fungus on the foot or between the toes, it’s going to say, ‘Wow, that’s steak up there on the nail. That’s real food. I’m just going to crawl back onto the nail because all my brothers up there are dead and there’s wide-open space,” Dr. Rosen explained.

He added that the reverse is also true: if a patient presents seeking treatment for athlete’s foot but also has onychomycosis, the best treatment results for the tinea pedis are obtained by also treating the nail infection.

Dr. Rosen offered a money-saving tip for effective OTC therapy for tinea pedis. Two words: Lotrimin Ultra. That’s the brand name for butenafine cream 1%, not to be confused with plain old Lotrimin, which is clotrimazole.

“Clotrimazole has been around since the dawn of man, and it’s not very effective. Many of the fungi are actually resistant to it. But they’re not resistant to butenafine, which is a very good topical antifungal now available over the counter. It costs $9 or $10 dollars for a tube the size of a baseball bat. It’s a good, effective, cheap way of treating concomitant tinea pedis,” he said.

Dr. Rosen reported serving on scientific advisory boards for Anacor, Merz, and Valeant.

SDEF and this news organization are owned by the same parent company.

[email protected]

WAIKOLOA, HAWAII – Two recent studies highlight several key points regarding topical therapy for onychomycosis: Treat it early for best results, and if concomitant tinea pedis is present, be sure to treat that, too, Dr. Theodore Rosen said at the Hawaii Dermatology Seminar.

The studies were separate secondary analyses of the pooled results of two large, double blind, vehicle-controlled, 48-week, phase III randomized trials of efinaconazole 10% topical solution (Jublia) for onychomycosis. But the same lessons probably apply to any topical antifungal, according to Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

Early treatment: This makes a big difference in outcome, as demonstrated in Dr. Phoebe Rich’s analysis of 1,655 patients in the phase III studies. Dr. Rich, director of the nail disorders clinic at Oregon Health and Science University, Portland, divided participants into three groups based upon disease duration: less than a year, 1-5 years, or more than 5 years. The complete cure rate was much better in the group with less than 1 year of onychomycosis, even though the extent of nail involvement of the target toenail didn’t differ significantly between the three groups (J Drugs Dermatol. 2015;Jan 14[1]:58-62).

“Now we have data: Don’t wait to treat until it has been there for 35 years. It’s easier to treat if it’s early,” Dr. Rosen commented at the seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

When onychomycosis and tinea pedis coexist, treat both: Dr. Leon H. Kircik of Indiana University, Indianapolis, and associates reported in a poster at the Hawaii Dermatology Seminar that one in five participants in the two phase III trials had tinea pedis as well as onychomycosis, and nearly half of them were treated for their athlete’s foot using their physician’s choice of topical antifungals.

The primary endpoint in the two trials was the week 53 complete cure rate, defined as no clinical involvement of the target toenail, a negative potassium hydroxide exam, and a negative fungal culture. Among subjects with concomitant onychomycosis and tinea pedis, the onychomycosis complete cure rate was 28.2% if they received efinaconazole for their onychomycosis and got treatment for their tinea pedis, compared with 20.9% if they got efinaconazole but no treatment for their tinea pedis. The complete/almost complete cure rate was 35.5% with dual therapy versus 29.6% if they only received efinaconazole. Both differences were significant.

“Doesn’t that make logical sense? If you leave the fungus on the foot or between the toes, it’s going to say, ‘Wow, that’s steak up there on the nail. That’s real food. I’m just going to crawl back onto the nail because all my brothers up there are dead and there’s wide-open space,” Dr. Rosen explained.

He added that the reverse is also true: if a patient presents seeking treatment for athlete’s foot but also has onychomycosis, the best treatment results for the tinea pedis are obtained by also treating the nail infection.

Dr. Rosen offered a money-saving tip for effective OTC therapy for tinea pedis. Two words: Lotrimin Ultra. That’s the brand name for butenafine cream 1%, not to be confused with plain old Lotrimin, which is clotrimazole.

“Clotrimazole has been around since the dawn of man, and it’s not very effective. Many of the fungi are actually resistant to it. But they’re not resistant to butenafine, which is a very good topical antifungal now available over the counter. It costs $9 or $10 dollars for a tube the size of a baseball bat. It’s a good, effective, cheap way of treating concomitant tinea pedis,” he said.

Dr. Rosen reported serving on scientific advisory boards for Anacor, Merz, and Valeant.

SDEF and this news organization are owned by the same parent company.

[email protected]

Gait speed was independently associated with hospitalization and death and aided in risk stratification of elderly patients with heart failure in a study reported online March 9 in JACC Heart Failure.

Optimal clinical management of heart failure is dependent on accurate prognostic stratification, Dr. Giovanni Pulignano and his coinvestigators wrote. Geriatric conditions such as frailty, cognitive impairment, and disability impact prognosis along with comorbidities and cardiac disease. Further, gait speed is a marker of frailty and is predictive of adverse health events in older patients, including mortality. However, there is limited research on the impact of geriatric conditions in heart failure studies.

©iStockphoto.com

Dr. Pulignano of San Camillo Hospital in Rome and colleagues sought to examine the relationship between gait speed in older patients with heart failure and the risk of hospitalization and death.

The investigators calculated the predicted all-cause mortality using the Cardiac and Comorbid Conditions Heart Failure (3C-HF) score. Variables included in the 3C-HF score are left ventricular ejection fraction of less than 20%, New York Heart Association class III-IV heart failure, no renin-angiotensin inhibitor treatment, no beta-blocker treatment, severe valvular heart disease, diabetes with macro- or microangiopathy, atrial fibrillation, hypertension, anemia, renal dysfunction, and older age.

Participants were at least 70 years old, with clinically stable heart failure with normal or reduced left ventricular ejection fraction and a previous hospitalization necessitating intravenous inotropes, diuretics, and/or vasodilators for heart failure.

Exclusion criteria included a condition that would decrease their walking speed, valvular heart disease with surgery planned, long-term intravenous inotrope treatment, or living in a nursing home.

Gait speed was assessed over 4 meters and grouped into groups of slow walkers (up to 0.65 m/s), intermediate walkers (0.66-0.99 m/s), and fast walkers (at least 1.0 m/s). Participants were allowed to use a walker or cane as a walking aid.

Data were analyzed on 331 patients (mean age 78 years, 43% women) with clinically stable and optimized chronic heart failure (mean NYHA class 2.7, mean left ventricular ejection fraction 35%). The mean 3C-HF score was 19.7 points.

The mean gait speed was 0.74 m/s, with 35% (115 patients) demonstrating severely reduced (less than or equal to 0.65 m/s) gait speed.

After 1 year of follow-up, they found a significant association between the measured gait speed and 1-year mortality, with 9.1%, 21.9%, and 38.3% for the high, intermediate, and low tertiles, respectively (P less than .001). A similar relationship was found for gait speed and heart failure–related hospitalization (26.6%, 58.6%, and 71.3%, respectively; P = .002) and all-cause hospitalization (26.6%, 58.6%, and 71.3%, respectively; P = .002).

Multivariate analysis revealed an independent association between gait speed and lower risk of all-cause death (hazard ratio, 0.62; P = .008). Gait speed was also associated with a lower risk for all-cause hospitalizations (HR, 0.74; P = .002) and heart failure–related hospitalizations (HR, 0.69; P = .004).

Finally, when gait speed was included in the 3C-HF risk score, accuracy of risk stratification for all-cause death (net reclassification improvement, 0.49; P less than .001) and heart failure admissions (NRI, 0.37; P less than .001) was improved (JCHF. 2016 Mar 9. doi:10.1016/j.jchf.2015.12.017).

“Gait speed, in combination with a validated clinical risk score, improves prognosis prediction in older HF patients,” the investigators concluded. “Frailty assessment using gait speed is simple and inexpensive and suggests new strategies for intervention. Its measurement should be incorporated in the routine clinical evaluation of older patients with HF.”

The study was supported by the ADRIANO-Italian Association for Research on Cardiac Disease in Older Patients. The authors had no disclosures.

Gait speed was independently associated with hospitalization and death and aided in risk stratification of elderly patients with heart failure in a study reported online March 9 in JACC Heart Failure.

Optimal clinical management of heart failure is dependent on accurate prognostic stratification, Dr. Giovanni Pulignano and his coinvestigators wrote. Geriatric conditions such as frailty, cognitive impairment, and disability impact prognosis along with comorbidities and cardiac disease. Further, gait speed is a marker of frailty and is predictive of adverse health events in older patients, including mortality. However, there is limited research on the impact of geriatric conditions in heart failure studies.

©iStockphoto.com

Dr. Pulignano of San Camillo Hospital in Rome and colleagues sought to examine the relationship between gait speed in older patients with heart failure and the risk of hospitalization and death.

The investigators calculated the predicted all-cause mortality using the Cardiac and Comorbid Conditions Heart Failure (3C-HF) score. Variables included in the 3C-HF score are left ventricular ejection fraction of less than 20%, New York Heart Association class III-IV heart failure, no renin-angiotensin inhibitor treatment, no beta-blocker treatment, severe valvular heart disease, diabetes with macro- or microangiopathy, atrial fibrillation, hypertension, anemia, renal dysfunction, and older age.

Participants were at least 70 years old, with clinically stable heart failure with normal or reduced left ventricular ejection fraction and a previous hospitalization necessitating intravenous inotropes, diuretics, and/or vasodilators for heart failure.

Exclusion criteria included a condition that would decrease their walking speed, valvular heart disease with surgery planned, long-term intravenous inotrope treatment, or living in a nursing home.

Gait speed was assessed over 4 meters and grouped into groups of slow walkers (up to 0.65 m/s), intermediate walkers (0.66-0.99 m/s), and fast walkers (at least 1.0 m/s). Participants were allowed to use a walker or cane as a walking aid.

Data were analyzed on 331 patients (mean age 78 years, 43% women) with clinically stable and optimized chronic heart failure (mean NYHA class 2.7, mean left ventricular ejection fraction 35%). The mean 3C-HF score was 19.7 points.

The mean gait speed was 0.74 m/s, with 35% (115 patients) demonstrating severely reduced (less than or equal to 0.65 m/s) gait speed.

After 1 year of follow-up, they found a significant association between the measured gait speed and 1-year mortality, with 9.1%, 21.9%, and 38.3% for the high, intermediate, and low tertiles, respectively (P less than .001). A similar relationship was found for gait speed and heart failure–related hospitalization (26.6%, 58.6%, and 71.3%, respectively; P = .002) and all-cause hospitalization (26.6%, 58.6%, and 71.3%, respectively; P = .002).

Multivariate analysis revealed an independent association between gait speed and lower risk of all-cause death (hazard ratio, 0.62; P = .008). Gait speed was also associated with a lower risk for all-cause hospitalizations (HR, 0.74; P = .002) and heart failure–related hospitalizations (HR, 0.69; P = .004).

Finally, when gait speed was included in the 3C-HF risk score, accuracy of risk stratification for all-cause death (net reclassification improvement, 0.49; P less than .001) and heart failure admissions (NRI, 0.37; P less than .001) was improved (JCHF. 2016 Mar 9. doi:10.1016/j.jchf.2015.12.017).

“Gait speed, in combination with a validated clinical risk score, improves prognosis prediction in older HF patients,” the investigators concluded. “Frailty assessment using gait speed is simple and inexpensive and suggests new strategies for intervention. Its measurement should be incorporated in the routine clinical evaluation of older patients with HF.”

The study was supported by the ADRIANO-Italian Association for Research on Cardiac Disease in Older Patients. The authors had no disclosures.

Gait speed was independently associated with hospitalization and death and aided in risk stratification of elderly patients with heart failure in a study reported online March 9 in JACC Heart Failure.

Optimal clinical management of heart failure is dependent on accurate prognostic stratification, Dr. Giovanni Pulignano and his coinvestigators wrote. Geriatric conditions such as frailty, cognitive impairment, and disability impact prognosis along with comorbidities and cardiac disease. Further, gait speed is a marker of frailty and is predictive of adverse health events in older patients, including mortality. However, there is limited research on the impact of geriatric conditions in heart failure studies.

©iStockphoto.com

Dr. Pulignano of San Camillo Hospital in Rome and colleagues sought to examine the relationship between gait speed in older patients with heart failure and the risk of hospitalization and death.

The investigators calculated the predicted all-cause mortality using the Cardiac and Comorbid Conditions Heart Failure (3C-HF) score. Variables included in the 3C-HF score are left ventricular ejection fraction of less than 20%, New York Heart Association class III-IV heart failure, no renin-angiotensin inhibitor treatment, no beta-blocker treatment, severe valvular heart disease, diabetes with macro- or microangiopathy, atrial fibrillation, hypertension, anemia, renal dysfunction, and older age.

Participants were at least 70 years old, with clinically stable heart failure with normal or reduced left ventricular ejection fraction and a previous hospitalization necessitating intravenous inotropes, diuretics, and/or vasodilators for heart failure.

Exclusion criteria included a condition that would decrease their walking speed, valvular heart disease with surgery planned, long-term intravenous inotrope treatment, or living in a nursing home.

Gait speed was assessed over 4 meters and grouped into groups of slow walkers (up to 0.65 m/s), intermediate walkers (0.66-0.99 m/s), and fast walkers (at least 1.0 m/s). Participants were allowed to use a walker or cane as a walking aid.

Data were analyzed on 331 patients (mean age 78 years, 43% women) with clinically stable and optimized chronic heart failure (mean NYHA class 2.7, mean left ventricular ejection fraction 35%). The mean 3C-HF score was 19.7 points.

The mean gait speed was 0.74 m/s, with 35% (115 patients) demonstrating severely reduced (less than or equal to 0.65 m/s) gait speed.

After 1 year of follow-up, they found a significant association between the measured gait speed and 1-year mortality, with 9.1%, 21.9%, and 38.3% for the high, intermediate, and low tertiles, respectively (P less than .001). A similar relationship was found for gait speed and heart failure–related hospitalization (26.6%, 58.6%, and 71.3%, respectively; P = .002) and all-cause hospitalization (26.6%, 58.6%, and 71.3%, respectively; P = .002).

Multivariate analysis revealed an independent association between gait speed and lower risk of all-cause death (hazard ratio, 0.62; P = .008). Gait speed was also associated with a lower risk for all-cause hospitalizations (HR, 0.74; P = .002) and heart failure–related hospitalizations (HR, 0.69; P = .004).

Finally, when gait speed was included in the 3C-HF risk score, accuracy of risk stratification for all-cause death (net reclassification improvement, 0.49; P less than .001) and heart failure admissions (NRI, 0.37; P less than .001) was improved (JCHF. 2016 Mar 9. doi:10.1016/j.jchf.2015.12.017).

“Gait speed, in combination with a validated clinical risk score, improves prognosis prediction in older HF patients,” the investigators concluded. “Frailty assessment using gait speed is simple and inexpensive and suggests new strategies for intervention. Its measurement should be incorporated in the routine clinical evaluation of older patients with HF.”

The study was supported by the ADRIANO-Italian Association for Research on Cardiac Disease in Older Patients. The authors had no disclosures.

BOSTON – Expanding access to health insurance for low- and moderate-income families has apparently improved colorectal cancer care in Massachusetts, and may do the same for other states that participate in Medicaid expansion under the Affordable Care Act.

That assertion comes from investigators at Massachusetts General Hospital in Boston. They found that following the introduction in 2006 of a universal health insurance law in the Bay State – the law that would serve as a model for the Affordable Care Act – the rate of elective colorectal resections increased while the rate of emergent resections decreased.

In contrast, in three states used as controls, the opposite occurred.

“This could be due to a variety of different factors, including earlier diagnosis, presenting with disease more amenable to surgical resection. It could also be due to increased referrals from primary care providers or GI doctors,” said Dr. Andrew P. Loehrer from the Massachusetts General Hospital Department of Surgery, at the annual Society of Surgical Oncology Cancer Symposium.

He acknowledged, however, that the administrative dataset he and his colleagues used in the study lacks information about clinical staging or use of neoadjuvant therapy, making it difficult to determine whether insured patients actually present at an earlier, more readily treatable disease stage.

Nonetheless, “from a cancer standpoint, my study provides early, hopeful evidence. In order to definitively say that this improves care, we need to have some more of the cancer-specific variables, but with this study, combined with some other work that we and other groups have done, we see that patients in Massachusetts are presenting with earlier stage disease, whether it’s acute disease or cancer, and they’re getting more appropriate care in a more timely fashion,” he said in an interview.

Role model

Dr. Loehrer noted that disparities in access to health care have been shown in previous studies to be associated with the likelihood of unfavorable outcomes for patients with colorectal cancer. For example, a 2008 study (Lancet Oncol. 2008 Mar;9:222-31) showed that uninsured patients with colorectal cancer had a twofold greater risk for presenting with advanced disease than privately insured patients. Additionally, a 2004 study (Br J Surg. 91:605-9) showed that patients who presented with colorectal cancer requiring emergent resection had significantly lower 5-year overall survival than patients who underwent elective resection.

Massachusetts implemented its pioneering health insurance reform law in 2006. The law increased eligibility for persons with incomes up to 150% of the Federal Poverty Level, created government-subsidized insurance for those with incomes from 150% to 300% of the poverty line, mandated that all Bay State residents have some form of health insurance, and allowed young adults up to the age of 26 to remain on their parents’ plans.

To see whether insurance reform could have a salutary effect on cancer care, the investigators drew on Agency for Health Research and Quality (AHRQ) State Inpatient Databases for Massachusetts and for Florida, New Jersey, and New York as control states. They used ICD-9 diagnosis codes to identify patients with colorectal cancer, including those who underwent resection.

To establish procedure rates, they used U.S. Census Bureau data to establish the population of denominators, which included all adults 18-54 years of age who were insured either through Medicaid, Commonwealth Care (in Massachusetts), or were listed as uninsured or self-pay. Medicare-insured patients were not included, as they were not directly affected by the reform law.

They identified 18,598 patients admitted to Massachusetts hospitals for colorectal cancer from 2001 through 2011, and 147,482 admitted during the same period to hospitals in the control states.

The authors created Poisson difference-in-differences models which compare changes in the selected outcomes in Massachusetts with changes in the control states. The models were adjusted for age, sex, race, hospital type, and secular trends.

They found that admission rates for colorectal cancer increased over time in Massachusetts by 13.3 per 100,000 residents per quarter, compared with 8.3/100,000 in the control states, translating into an adjusted rate ratio (ARR) of 1.13. Resection rates for cancer, the primary study outcome, also grew by a significantly larger margin in Massachusetts, by 5.5/100,000, compared with 0.5/100,000 in control states, with an ARR of 1.37 (P less than .001 for both comparisons).

For the secondary outcome of changes in emergent and elective resections after admission, they found that emergent surgeries in Massachusetts declined by 2.7/100,000, but increased by 4.4/100,000 in the states without insurance reform. Similarly, elective resections after admission increased in the Bay State by 7.4/100,000, but decreased by 1.8/100,000 in control states.

Relative to controls, the adjusted probability that a patient with colorectal cancer in Massachusetts would have emergent surgery after admission declined by 6.1% (P = .014) and the probability that he or she would have elective resection increased by 7.8% (P = .005).

An analysis of the odds ratio of resection during admission, adjusted for age, race, presentation with metastatic disease, hospital type, and secular trends, showed that prior to reform uninsured patients in both Massachusetts and control states were significantly less likely than privately insured patients to have resections (odds ratio, 0.42 in Mass.; 0.45 in control states).

However, after the implementation of reform the gap between previously uninsured and privately insured in Massachusetts narrowed (OR, 0.63) but remained the same in control states (OR, 0.44).

Dr. Loehrer acknowledged in an interview that Massachusetts differs from other states in some regards, including in concentrations of health providers and in requirements for insurance coverage that were in place even before the 2006 reforms, but is optimistic that improvements in colorectal cancer care can occur in states that have embraced the Affordable Care Act.

“There are a lot of services that were available and we had high colonoscopy rates prior to all of this, but that said, the mechanism is exactly the same, there are still vulnerable populations, and at this point I think it’s hopeful and promising that we will see similar results in other states,” he said.

BOSTON – Expanding access to health insurance for low- and moderate-income families has apparently improved colorectal cancer care in Massachusetts, and may do the same for other states that participate in Medicaid expansion under the Affordable Care Act.

That assertion comes from investigators at Massachusetts General Hospital in Boston. They found that following the introduction in 2006 of a universal health insurance law in the Bay State – the law that would serve as a model for the Affordable Care Act – the rate of elective colorectal resections increased while the rate of emergent resections decreased.

In contrast, in three states used as controls, the opposite occurred.

“This could be due to a variety of different factors, including earlier diagnosis, presenting with disease more amenable to surgical resection. It could also be due to increased referrals from primary care providers or GI doctors,” said Dr. Andrew P. Loehrer from the Massachusetts General Hospital Department of Surgery, at the annual Society of Surgical Oncology Cancer Symposium.

He acknowledged, however, that the administrative dataset he and his colleagues used in the study lacks information about clinical staging or use of neoadjuvant therapy, making it difficult to determine whether insured patients actually present at an earlier, more readily treatable disease stage.

Nonetheless, “from a cancer standpoint, my study provides early, hopeful evidence. In order to definitively say that this improves care, we need to have some more of the cancer-specific variables, but with this study, combined with some other work that we and other groups have done, we see that patients in Massachusetts are presenting with earlier stage disease, whether it’s acute disease or cancer, and they’re getting more appropriate care in a more timely fashion,” he said in an interview.

Role model

Dr. Loehrer noted that disparities in access to health care have been shown in previous studies to be associated with the likelihood of unfavorable outcomes for patients with colorectal cancer. For example, a 2008 study (Lancet Oncol. 2008 Mar;9:222-31) showed that uninsured patients with colorectal cancer had a twofold greater risk for presenting with advanced disease than privately insured patients. Additionally, a 2004 study (Br J Surg. 91:605-9) showed that patients who presented with colorectal cancer requiring emergent resection had significantly lower 5-year overall survival than patients who underwent elective resection.

Massachusetts implemented its pioneering health insurance reform law in 2006. The law increased eligibility for persons with incomes up to 150% of the Federal Poverty Level, created government-subsidized insurance for those with incomes from 150% to 300% of the poverty line, mandated that all Bay State residents have some form of health insurance, and allowed young adults up to the age of 26 to remain on their parents’ plans.

To see whether insurance reform could have a salutary effect on cancer care, the investigators drew on Agency for Health Research and Quality (AHRQ) State Inpatient Databases for Massachusetts and for Florida, New Jersey, and New York as control states. They used ICD-9 diagnosis codes to identify patients with colorectal cancer, including those who underwent resection.

To establish procedure rates, they used U.S. Census Bureau data to establish the population of denominators, which included all adults 18-54 years of age who were insured either through Medicaid, Commonwealth Care (in Massachusetts), or were listed as uninsured or self-pay. Medicare-insured patients were not included, as they were not directly affected by the reform law.

They identified 18,598 patients admitted to Massachusetts hospitals for colorectal cancer from 2001 through 2011, and 147,482 admitted during the same period to hospitals in the control states.

The authors created Poisson difference-in-differences models which compare changes in the selected outcomes in Massachusetts with changes in the control states. The models were adjusted for age, sex, race, hospital type, and secular trends.

They found that admission rates for colorectal cancer increased over time in Massachusetts by 13.3 per 100,000 residents per quarter, compared with 8.3/100,000 in the control states, translating into an adjusted rate ratio (ARR) of 1.13. Resection rates for cancer, the primary study outcome, also grew by a significantly larger margin in Massachusetts, by 5.5/100,000, compared with 0.5/100,000 in control states, with an ARR of 1.37 (P less than .001 for both comparisons).

For the secondary outcome of changes in emergent and elective resections after admission, they found that emergent surgeries in Massachusetts declined by 2.7/100,000, but increased by 4.4/100,000 in the states without insurance reform. Similarly, elective resections after admission increased in the Bay State by 7.4/100,000, but decreased by 1.8/100,000 in control states.

Relative to controls, the adjusted probability that a patient with colorectal cancer in Massachusetts would have emergent surgery after admission declined by 6.1% (P = .014) and the probability that he or she would have elective resection increased by 7.8% (P = .005).

An analysis of the odds ratio of resection during admission, adjusted for age, race, presentation with metastatic disease, hospital type, and secular trends, showed that prior to reform uninsured patients in both Massachusetts and control states were significantly less likely than privately insured patients to have resections (odds ratio, 0.42 in Mass.; 0.45 in control states).

However, after the implementation of reform the gap between previously uninsured and privately insured in Massachusetts narrowed (OR, 0.63) but remained the same in control states (OR, 0.44).

Dr. Loehrer acknowledged in an interview that Massachusetts differs from other states in some regards, including in concentrations of health providers and in requirements for insurance coverage that were in place even before the 2006 reforms, but is optimistic that improvements in colorectal cancer care can occur in states that have embraced the Affordable Care Act.

“There are a lot of services that were available and we had high colonoscopy rates prior to all of this, but that said, the mechanism is exactly the same, there are still vulnerable populations, and at this point I think it’s hopeful and promising that we will see similar results in other states,” he said.

BOSTON – Expanding access to health insurance for low- and moderate-income families has apparently improved colorectal cancer care in Massachusetts, and may do the same for other states that participate in Medicaid expansion under the Affordable Care Act.

That assertion comes from investigators at Massachusetts General Hospital in Boston. They found that following the introduction in 2006 of a universal health insurance law in the Bay State – the law that would serve as a model for the Affordable Care Act – the rate of elective colorectal resections increased while the rate of emergent resections decreased.

In contrast, in three states used as controls, the opposite occurred.

“This could be due to a variety of different factors, including earlier diagnosis, presenting with disease more amenable to surgical resection. It could also be due to increased referrals from primary care providers or GI doctors,” said Dr. Andrew P. Loehrer from the Massachusetts General Hospital Department of Surgery, at the annual Society of Surgical Oncology Cancer Symposium.

He acknowledged, however, that the administrative dataset he and his colleagues used in the study lacks information about clinical staging or use of neoadjuvant therapy, making it difficult to determine whether insured patients actually present at an earlier, more readily treatable disease stage.

Nonetheless, “from a cancer standpoint, my study provides early, hopeful evidence. In order to definitively say that this improves care, we need to have some more of the cancer-specific variables, but with this study, combined with some other work that we and other groups have done, we see that patients in Massachusetts are presenting with earlier stage disease, whether it’s acute disease or cancer, and they’re getting more appropriate care in a more timely fashion,” he said in an interview.

Role model

Dr. Loehrer noted that disparities in access to health care have been shown in previous studies to be associated with the likelihood of unfavorable outcomes for patients with colorectal cancer. For example, a 2008 study (Lancet Oncol. 2008 Mar;9:222-31) showed that uninsured patients with colorectal cancer had a twofold greater risk for presenting with advanced disease than privately insured patients. Additionally, a 2004 study (Br J Surg. 91:605-9) showed that patients who presented with colorectal cancer requiring emergent resection had significantly lower 5-year overall survival than patients who underwent elective resection.

Massachusetts implemented its pioneering health insurance reform law in 2006. The law increased eligibility for persons with incomes up to 150% of the Federal Poverty Level, created government-subsidized insurance for those with incomes from 150% to 300% of the poverty line, mandated that all Bay State residents have some form of health insurance, and allowed young adults up to the age of 26 to remain on their parents’ plans.

To see whether insurance reform could have a salutary effect on cancer care, the investigators drew on Agency for Health Research and Quality (AHRQ) State Inpatient Databases for Massachusetts and for Florida, New Jersey, and New York as control states. They used ICD-9 diagnosis codes to identify patients with colorectal cancer, including those who underwent resection.

To establish procedure rates, they used U.S. Census Bureau data to establish the population of denominators, which included all adults 18-54 years of age who were insured either through Medicaid, Commonwealth Care (in Massachusetts), or were listed as uninsured or self-pay. Medicare-insured patients were not included, as they were not directly affected by the reform law.

They identified 18,598 patients admitted to Massachusetts hospitals for colorectal cancer from 2001 through 2011, and 147,482 admitted during the same period to hospitals in the control states.

The authors created Poisson difference-in-differences models which compare changes in the selected outcomes in Massachusetts with changes in the control states. The models were adjusted for age, sex, race, hospital type, and secular trends.

They found that admission rates for colorectal cancer increased over time in Massachusetts by 13.3 per 100,000 residents per quarter, compared with 8.3/100,000 in the control states, translating into an adjusted rate ratio (ARR) of 1.13. Resection rates for cancer, the primary study outcome, also grew by a significantly larger margin in Massachusetts, by 5.5/100,000, compared with 0.5/100,000 in control states, with an ARR of 1.37 (P less than .001 for both comparisons).

For the secondary outcome of changes in emergent and elective resections after admission, they found that emergent surgeries in Massachusetts declined by 2.7/100,000, but increased by 4.4/100,000 in the states without insurance reform. Similarly, elective resections after admission increased in the Bay State by 7.4/100,000, but decreased by 1.8/100,000 in control states.

Relative to controls, the adjusted probability that a patient with colorectal cancer in Massachusetts would have emergent surgery after admission declined by 6.1% (P = .014) and the probability that he or she would have elective resection increased by 7.8% (P = .005).

An analysis of the odds ratio of resection during admission, adjusted for age, race, presentation with metastatic disease, hospital type, and secular trends, showed that prior to reform uninsured patients in both Massachusetts and control states were significantly less likely than privately insured patients to have resections (odds ratio, 0.42 in Mass.; 0.45 in control states).

However, after the implementation of reform the gap between previously uninsured and privately insured in Massachusetts narrowed (OR, 0.63) but remained the same in control states (OR, 0.44).

Dr. Loehrer acknowledged in an interview that Massachusetts differs from other states in some regards, including in concentrations of health providers and in requirements for insurance coverage that were in place even before the 2006 reforms, but is optimistic that improvements in colorectal cancer care can occur in states that have embraced the Affordable Care Act.

“There are a lot of services that were available and we had high colonoscopy rates prior to all of this, but that said, the mechanism is exactly the same, there are still vulnerable populations, and at this point I think it’s hopeful and promising that we will see similar results in other states,” he said.

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

[email protected]

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

[email protected]

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

[email protected]