Patients with diabetes—especially the elderly—are at high risk for morbidity and mortality due to cancer, studies have shown. Researchers from Specialist District Hospital and University of Rzeszow in Poland say their study “sheds some new light” in demonstrating another kind of association between diabetes and cancer in older patients: a higher risk of hospitalization with surgery due to cancer.

They analyzed data on 7,694 patients aged > 45 years hospitalized in a surgery ward. Of those, 652 were diagnosed with cancer and 370 with diabetes; 93 patients had both. The most common kind of cancer was urinary bladder cancer. The researchers note that their surgical unit has a large urology subdivision. Patients with other site-specific cancers are usually referred to more specialized clinical units.

Diabetes was the strongest predictor of risk among the variables analyzed, although urban residence also was a significant predictor. Risk of hospitalization due to cancer doubled among diabetic patients aged 45 to  65 years and was > 5 times higher among patients aged > 65 years, compared with the nondiabetic patients. The highest risk of hospitalization for site-specific cancers was among patients with kidney and breast cancers.

The researchers say their findings suggest that it is “advisable to make major efforts” for early detection and early radical treatment in older patients with diabetes. 

Source:

Dᾳbrowski M, Grindecka A. Arch Med Sci. 2017;13(5):1025-1030.
doi: 10.5114/aoms.2016.58666.

Patients with diabetes—especially the elderly—are at high risk for morbidity and mortality due to cancer, studies have shown. Researchers from Specialist District Hospital and University of Rzeszow in Poland say their study “sheds some new light” in demonstrating another kind of association between diabetes and cancer in older patients: a higher risk of hospitalization with surgery due to cancer.

They analyzed data on 7,694 patients aged > 45 years hospitalized in a surgery ward. Of those, 652 were diagnosed with cancer and 370 with diabetes; 93 patients had both. The most common kind of cancer was urinary bladder cancer. The researchers note that their surgical unit has a large urology subdivision. Patients with other site-specific cancers are usually referred to more specialized clinical units.

Diabetes was the strongest predictor of risk among the variables analyzed, although urban residence also was a significant predictor. Risk of hospitalization due to cancer doubled among diabetic patients aged 45 to  65 years and was > 5 times higher among patients aged > 65 years, compared with the nondiabetic patients. The highest risk of hospitalization for site-specific cancers was among patients with kidney and breast cancers.

The researchers say their findings suggest that it is “advisable to make major efforts” for early detection and early radical treatment in older patients with diabetes. 

Source:

Dᾳbrowski M, Grindecka A. Arch Med Sci. 2017;13(5):1025-1030.
doi: 10.5114/aoms.2016.58666.

Patients with diabetes—especially the elderly—are at high risk for morbidity and mortality due to cancer, studies have shown. Researchers from Specialist District Hospital and University of Rzeszow in Poland say their study “sheds some new light” in demonstrating another kind of association between diabetes and cancer in older patients: a higher risk of hospitalization with surgery due to cancer.

They analyzed data on 7,694 patients aged > 45 years hospitalized in a surgery ward. Of those, 652 were diagnosed with cancer and 370 with diabetes; 93 patients had both. The most common kind of cancer was urinary bladder cancer. The researchers note that their surgical unit has a large urology subdivision. Patients with other site-specific cancers are usually referred to more specialized clinical units.

Diabetes was the strongest predictor of risk among the variables analyzed, although urban residence also was a significant predictor. Risk of hospitalization due to cancer doubled among diabetic patients aged 45 to  65 years and was > 5 times higher among patients aged > 65 years, compared with the nondiabetic patients. The highest risk of hospitalization for site-specific cancers was among patients with kidney and breast cancers.

The researchers say their findings suggest that it is “advisable to make major efforts” for early detection and early radical treatment in older patients with diabetes. 

Source:

Dᾳbrowski M, Grindecka A. Arch Med Sci. 2017;13(5):1025-1030.
doi: 10.5114/aoms.2016.58666.

Photo by Bill Branson

The US Food and Drug Administration (FDA) has approved inotuzumab ozogamicin (Besponsa®) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The labeling for inotuzumab ozogamicin includes a boxed warning stating that the drug poses a risk of hepatotoxicity, including hepatic veno-occlusive disease (or sinusoidal obstruction syndrome), as well as an increased risk of post-transplant non-relapse mortality.

The full prescribing information for inotuzumab ozogamicin is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf.

Inotuzumab ozogamicin is an antibody-drug conjugate that consists of a monoclonal antibody targeting CD22 and a cytotoxic agent known as calicheamicin.

The product originates from a collaboration between Pfizer and Celltech (now UCB), but Pfizer has sole responsibility for all manufacturing and clinical development activities.

Inotuzumab ozogamicin was reviewed and approved under the FDA’s breakthrough therapy designation and priority review programs.

The application for inotuzumab ozogamicin was supported by results from the phase 3 INO-VATE trial, which were published in NEJM in June 2016.

The trial enrolled 326 adults with relapsed or refractory B-cell ALL. Patients received inotuzumab ozogamicin or 1 of 3 chemotherapy regimens (high-dose cytarabine, cytarabine plus mitoxantrone, or fludarabine, cytarabine, and granulocyte colony-stimulating factor).

The rate of complete remission, including incomplete hematologic recovery, was 80.7% in the inotuzumab arm and 29.4% in the chemotherapy arm (P<0.001). The median duration of remission was 4.6 months and 3.1 months, respectively (P=0.03).

Forty-one percent of patients treated with inotuzumab and 11% of those who received chemotherapy proceeded to stem cell transplant directly after treatment (P<0.001).

The median progression-free survival was 5.0 months in the inotuzumab arm and 1.8 months in the chemotherapy arm (P<0.001).

The median overall survival was 7.7 months and 6.7 months, respectively (P=0.04). This did not meet the prespecified boundary of significance (P=0.0208).

Liver-related adverse events were more common in the inotuzumab arm than the chemotherapy arm. The most frequent of these were increased aspartate aminotransferase level (20% vs 10%), hyperbilirubinemia (15% vs 10%), and increased alanine aminotransferase level (14% vs 11%).

Veno-occlusive liver disease occurred in 11% of patients in the inotuzumab arm and 1% in the chemotherapy arm.

There were 17 deaths during treatment in the inotuzumab arm and 11 in the chemotherapy arm. Four deaths were considered related to inotuzumab, and 2 were thought to be related to chemotherapy.

Photo by Bill Branson

The US Food and Drug Administration (FDA) has approved inotuzumab ozogamicin (Besponsa®) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The labeling for inotuzumab ozogamicin includes a boxed warning stating that the drug poses a risk of hepatotoxicity, including hepatic veno-occlusive disease (or sinusoidal obstruction syndrome), as well as an increased risk of post-transplant non-relapse mortality.

The full prescribing information for inotuzumab ozogamicin is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf.

Inotuzumab ozogamicin is an antibody-drug conjugate that consists of a monoclonal antibody targeting CD22 and a cytotoxic agent known as calicheamicin.

The product originates from a collaboration between Pfizer and Celltech (now UCB), but Pfizer has sole responsibility for all manufacturing and clinical development activities.

Inotuzumab ozogamicin was reviewed and approved under the FDA’s breakthrough therapy designation and priority review programs.

The application for inotuzumab ozogamicin was supported by results from the phase 3 INO-VATE trial, which were published in NEJM in June 2016.

The trial enrolled 326 adults with relapsed or refractory B-cell ALL. Patients received inotuzumab ozogamicin or 1 of 3 chemotherapy regimens (high-dose cytarabine, cytarabine plus mitoxantrone, or fludarabine, cytarabine, and granulocyte colony-stimulating factor).

The rate of complete remission, including incomplete hematologic recovery, was 80.7% in the inotuzumab arm and 29.4% in the chemotherapy arm (P<0.001). The median duration of remission was 4.6 months and 3.1 months, respectively (P=0.03).

Forty-one percent of patients treated with inotuzumab and 11% of those who received chemotherapy proceeded to stem cell transplant directly after treatment (P<0.001).

The median progression-free survival was 5.0 months in the inotuzumab arm and 1.8 months in the chemotherapy arm (P<0.001).

The median overall survival was 7.7 months and 6.7 months, respectively (P=0.04). This did not meet the prespecified boundary of significance (P=0.0208).

Liver-related adverse events were more common in the inotuzumab arm than the chemotherapy arm. The most frequent of these were increased aspartate aminotransferase level (20% vs 10%), hyperbilirubinemia (15% vs 10%), and increased alanine aminotransferase level (14% vs 11%).

Veno-occlusive liver disease occurred in 11% of patients in the inotuzumab arm and 1% in the chemotherapy arm.

There were 17 deaths during treatment in the inotuzumab arm and 11 in the chemotherapy arm. Four deaths were considered related to inotuzumab, and 2 were thought to be related to chemotherapy.

Photo by Bill Branson

The US Food and Drug Administration (FDA) has approved inotuzumab ozogamicin (Besponsa®) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The labeling for inotuzumab ozogamicin includes a boxed warning stating that the drug poses a risk of hepatotoxicity, including hepatic veno-occlusive disease (or sinusoidal obstruction syndrome), as well as an increased risk of post-transplant non-relapse mortality.

The full prescribing information for inotuzumab ozogamicin is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf.

Inotuzumab ozogamicin is an antibody-drug conjugate that consists of a monoclonal antibody targeting CD22 and a cytotoxic agent known as calicheamicin.

The product originates from a collaboration between Pfizer and Celltech (now UCB), but Pfizer has sole responsibility for all manufacturing and clinical development activities.

Inotuzumab ozogamicin was reviewed and approved under the FDA’s breakthrough therapy designation and priority review programs.

The application for inotuzumab ozogamicin was supported by results from the phase 3 INO-VATE trial, which were published in NEJM in June 2016.

The trial enrolled 326 adults with relapsed or refractory B-cell ALL. Patients received inotuzumab ozogamicin or 1 of 3 chemotherapy regimens (high-dose cytarabine, cytarabine plus mitoxantrone, or fludarabine, cytarabine, and granulocyte colony-stimulating factor).

The rate of complete remission, including incomplete hematologic recovery, was 80.7% in the inotuzumab arm and 29.4% in the chemotherapy arm (P<0.001). The median duration of remission was 4.6 months and 3.1 months, respectively (P=0.03).

Forty-one percent of patients treated with inotuzumab and 11% of those who received chemotherapy proceeded to stem cell transplant directly after treatment (P<0.001).

The median progression-free survival was 5.0 months in the inotuzumab arm and 1.8 months in the chemotherapy arm (P<0.001).

The median overall survival was 7.7 months and 6.7 months, respectively (P=0.04). This did not meet the prespecified boundary of significance (P=0.0208).

Liver-related adverse events were more common in the inotuzumab arm than the chemotherapy arm. The most frequent of these were increased aspartate aminotransferase level (20% vs 10%), hyperbilirubinemia (15% vs 10%), and increased alanine aminotransferase level (14% vs 11%).

Veno-occlusive liver disease occurred in 11% of patients in the inotuzumab arm and 1% in the chemotherapy arm.

There were 17 deaths during treatment in the inotuzumab arm and 11 in the chemotherapy arm. Four deaths were considered related to inotuzumab, and 2 were thought to be related to chemotherapy.

Photo by Darren Baker

A new study indicates that survivors of the Holocaust have experienced a small but consistent increase in the risk of developing cancer.

The findings, published in the journal Cancer, offer an example of how extreme population-level tragedies can have an impact on health.

Holocaust survivors were exposed to a variety of factors that have been linked with cancer.

So researchers set out to investigate whether the starvation, overcrowding, infectious diseases, and psychological stress that survivors endured might have contributed to the development of cancer in some individuals.

The team studied 152,622 Holocaust survivors who were followed for more than 45 years.

The researchers used 2 definitions of exposure to classify the survivors.

One definition was based on an individual’s entitlement for compensation for suffering persecution during the war. The other was based on the country of origin, dividing countries into those that were directly governed by Nazi Germany and those that were not occupied by Nazis.

The cancer incidence was significantly higher in survivors who were granted compensation than in those who were not—21.9% and 16.1%, respectively (P<0.0001).

However, the difference between survivors from occupied and non-occupied countries was not significant—22.7% and 21.4%, respectively.

On the other hand, when the researchers adjusted for confounding factors, survivors who had been exposed by either definition had a significantly increased risk of cancer.

For survivors who were granted compensation, the hazard ratio (HR) was 1.06 (P<0.001). For survivors born in occupied countries, the HR was 1.08 (P<0.001).

There was no increased risk of acute or chronic leukemia among patients who received compensation. And there was no increased risk of acute leukemia for survivors born in occupied countries.

However, there was a significantly increased risk of chronic leukemia among survivors born in occupied countries (HR=1.33, P=0.001)

“The data emphasize the importance of learning about the combined effect of several exposures occurring intensely and contemporaneously on cancer risk, such as those that unfortunately occurred during World War II,” said study author Siegal Sadetzki, MD, of the Chaim Sheba Medical Center in Tel HaShomer, Israel.

An editorial related to this study noted that the association between cancer and the extreme deprivation experienced by Holocaust survivors may also have parallels with other extreme population-level events, including in racial/ethnic minority groups experiencing severe social deprivation over time.

Photo by Darren Baker

A new study indicates that survivors of the Holocaust have experienced a small but consistent increase in the risk of developing cancer.

The findings, published in the journal Cancer, offer an example of how extreme population-level tragedies can have an impact on health.

Holocaust survivors were exposed to a variety of factors that have been linked with cancer.

So researchers set out to investigate whether the starvation, overcrowding, infectious diseases, and psychological stress that survivors endured might have contributed to the development of cancer in some individuals.

The team studied 152,622 Holocaust survivors who were followed for more than 45 years.

The researchers used 2 definitions of exposure to classify the survivors.

One definition was based on an individual’s entitlement for compensation for suffering persecution during the war. The other was based on the country of origin, dividing countries into those that were directly governed by Nazi Germany and those that were not occupied by Nazis.

The cancer incidence was significantly higher in survivors who were granted compensation than in those who were not—21.9% and 16.1%, respectively (P<0.0001).

However, the difference between survivors from occupied and non-occupied countries was not significant—22.7% and 21.4%, respectively.

On the other hand, when the researchers adjusted for confounding factors, survivors who had been exposed by either definition had a significantly increased risk of cancer.

For survivors who were granted compensation, the hazard ratio (HR) was 1.06 (P<0.001). For survivors born in occupied countries, the HR was 1.08 (P<0.001).

There was no increased risk of acute or chronic leukemia among patients who received compensation. And there was no increased risk of acute leukemia for survivors born in occupied countries.

However, there was a significantly increased risk of chronic leukemia among survivors born in occupied countries (HR=1.33, P=0.001)

“The data emphasize the importance of learning about the combined effect of several exposures occurring intensely and contemporaneously on cancer risk, such as those that unfortunately occurred during World War II,” said study author Siegal Sadetzki, MD, of the Chaim Sheba Medical Center in Tel HaShomer, Israel.

An editorial related to this study noted that the association between cancer and the extreme deprivation experienced by Holocaust survivors may also have parallels with other extreme population-level events, including in racial/ethnic minority groups experiencing severe social deprivation over time.

Photo by Darren Baker

A new study indicates that survivors of the Holocaust have experienced a small but consistent increase in the risk of developing cancer.

The findings, published in the journal Cancer, offer an example of how extreme population-level tragedies can have an impact on health.

Holocaust survivors were exposed to a variety of factors that have been linked with cancer.

So researchers set out to investigate whether the starvation, overcrowding, infectious diseases, and psychological stress that survivors endured might have contributed to the development of cancer in some individuals.

The team studied 152,622 Holocaust survivors who were followed for more than 45 years.

The researchers used 2 definitions of exposure to classify the survivors.

One definition was based on an individual’s entitlement for compensation for suffering persecution during the war. The other was based on the country of origin, dividing countries into those that were directly governed by Nazi Germany and those that were not occupied by Nazis.

The cancer incidence was significantly higher in survivors who were granted compensation than in those who were not—21.9% and 16.1%, respectively (P<0.0001).

However, the difference between survivors from occupied and non-occupied countries was not significant—22.7% and 21.4%, respectively.

On the other hand, when the researchers adjusted for confounding factors, survivors who had been exposed by either definition had a significantly increased risk of cancer.

For survivors who were granted compensation, the hazard ratio (HR) was 1.06 (P<0.001). For survivors born in occupied countries, the HR was 1.08 (P<0.001).

There was no increased risk of acute or chronic leukemia among patients who received compensation. And there was no increased risk of acute leukemia for survivors born in occupied countries.

However, there was a significantly increased risk of chronic leukemia among survivors born in occupied countries (HR=1.33, P=0.001)

“The data emphasize the importance of learning about the combined effect of several exposures occurring intensely and contemporaneously on cancer risk, such as those that unfortunately occurred during World War II,” said study author Siegal Sadetzki, MD, of the Chaim Sheba Medical Center in Tel HaShomer, Israel.

An editorial related to this study noted that the association between cancer and the extreme deprivation experienced by Holocaust survivors may also have parallels with other extreme population-level events, including in racial/ethnic minority groups experiencing severe social deprivation over time.

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has made available a panel of human plasma samples that can be used to evaluate serological tests for detecting Zika virus infection.

The panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses.

Diagnostic developers can use the panel to assess whether their tests can help distinguish recent Zika virus infection from infection with West Nile or dengue.

The panel is available to developers who have interacted with the FDA and are seeking Emergency Use Authorization (EUA) for devices that are in the final stages of validation.

Other developers interested in requesting a panel may contact the FDA at [email protected].

The agency said the panel can also be used to compare the performance of Zika virus tests that are already available under an EUA.

To date, the FDA has granted EUAs to 3 serological tests for detection of recent Zika virus infection: Zika MAC-ELISA, ZIKV Detect IgM Capture ELISA, and LIAISON XL Zika Capture IgM Assay.

“At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, MD.

“By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.”

The FDA panel was prepared using samples from Zika virus-infected individuals provided by Blood Systems Research Institute. The samples from individuals infected with dengue and West Nile virus were obtained separately.

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has made available a panel of human plasma samples that can be used to evaluate serological tests for detecting Zika virus infection.

The panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses.

Diagnostic developers can use the panel to assess whether their tests can help distinguish recent Zika virus infection from infection with West Nile or dengue.

The panel is available to developers who have interacted with the FDA and are seeking Emergency Use Authorization (EUA) for devices that are in the final stages of validation.

Other developers interested in requesting a panel may contact the FDA at [email protected].

The agency said the panel can also be used to compare the performance of Zika virus tests that are already available under an EUA.

To date, the FDA has granted EUAs to 3 serological tests for detection of recent Zika virus infection: Zika MAC-ELISA, ZIKV Detect IgM Capture ELISA, and LIAISON XL Zika Capture IgM Assay.

“At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, MD.

“By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.”

The FDA panel was prepared using samples from Zika virus-infected individuals provided by Blood Systems Research Institute. The samples from individuals infected with dengue and West Nile virus were obtained separately.

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has made available a panel of human plasma samples that can be used to evaluate serological tests for detecting Zika virus infection.

The panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses.

Diagnostic developers can use the panel to assess whether their tests can help distinguish recent Zika virus infection from infection with West Nile or dengue.

The panel is available to developers who have interacted with the FDA and are seeking Emergency Use Authorization (EUA) for devices that are in the final stages of validation.

Other developers interested in requesting a panel may contact the FDA at [email protected].

The agency said the panel can also be used to compare the performance of Zika virus tests that are already available under an EUA.

To date, the FDA has granted EUAs to 3 serological tests for detection of recent Zika virus infection: Zika MAC-ELISA, ZIKV Detect IgM Capture ELISA, and LIAISON XL Zika Capture IgM Assay.

“At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, MD.

“By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.”

The FDA panel was prepared using samples from Zika virus-infected individuals provided by Blood Systems Research Institute. The samples from individuals infected with dengue and West Nile virus were obtained separately.

The use of oral contraceptives may be associated with a reduced risk of rheumatoid arthritis based on findings from a large, population-based, case-control study in Sweden.

The lowered risk for rheumatoid arthritis in the study conducted by Cecilia Orellana, PhD, of the Institute of Environmental Medicine at the Karolinska Institute, Stockholm, and her coauthors applied only to patients who tested positive for anticitrullinated protein antibodies (ACPA) and to those who used oral contraceptives for 7 or more years. The investigators also found a significant reduction in RA risk for women who breastfed their children.

areeya_ann/Thinkstock

The use of oral contraceptives may be associated with a reduced risk of rheumatoid arthritis based on findings from a large, population-based, case-control study in Sweden.

The lowered risk for rheumatoid arthritis in the study conducted by Cecilia Orellana, PhD, of the Institute of Environmental Medicine at the Karolinska Institute, Stockholm, and her coauthors applied only to patients who tested positive for anticitrullinated protein antibodies (ACPA) and to those who used oral contraceptives for 7 or more years. The investigators also found a significant reduction in RA risk for women who breastfed their children.

areeya_ann/Thinkstock

The use of oral contraceptives may be associated with a reduced risk of rheumatoid arthritis based on findings from a large, population-based, case-control study in Sweden.

The lowered risk for rheumatoid arthritis in the study conducted by Cecilia Orellana, PhD, of the Institute of Environmental Medicine at the Karolinska Institute, Stockholm, and her coauthors applied only to patients who tested positive for anticitrullinated protein antibodies (ACPA) and to those who used oral contraceptives for 7 or more years. The investigators also found a significant reduction in RA risk for women who breastfed their children.

areeya_ann/Thinkstock

The sinus of Valsalva segment can be preserved during aortic valve replacement irrespective of the type of valve pathology, according to a recent study by Rita Karianna Milewski, MD, and her colleagues at the Hospital of the University of Pennsylvania, Philadelphia.

Severe aortic root dilation coupled to aortic valve disease requires root replacement in patients with a tricuspid or bicuspid aortic valve. Commonly, an aortic valve replacement and supracoronary ascending aorta replacement (AVRSCAAR) procedure has been used for patients who have a mild to moderately dilated sinus segment. One advantage of the procedure is that it retains the sinus of Valsalva (SOV) and preserves the intact coronary ostia.

However, the long-term behavior and risk of aortic events for the retained SOV in both BAV and TAV patients remains unclear, according to Dr. Milewski and her colleagues.

Previous researchers have suggested that patients with BAV and TAV have different rates of complications of the remaining aorta and dilation of the proximal aorta and retained sinus segment. In addition, it has been suggested that the cause of aortic dilation is different in patients with aortic stenosis (AS) and aortic insufficiency (AI) and is based on TAV and BAV morphology, histology, and hemodynamic flow patterns.

However, in the August issue of the Journal of Thoracic and Cardiovascular Surgery, Dr. Milewski and her colleagues reported on their study showing that, in patients with nonaneurysmal SOV undergoing AVRSCAAR, the sinus of Valsalva segment can be preserved regardless of the type of valvular pathology (aortic stenosis vs. aortic insufficiency) or valvular morphology (BAV vs. TAV).

The researchers retrospectively reviewed a prospectively maintained institutional database to stratify all patients by BAV or TAV valvular pathology with concomitant ascending aortic aneurysm who underwent an elective AVRSCAAR from 2002 to 2015 (J Thorac Cardiovasc Surg. 2017;154:421-32).

The distribution of the 428 patients meeting inclusion criteria by subgroups was: BAV group (254 patients: BAV-AS = 178; BAV-AI = 76); TAV group (174 patients: TAV-AS = 61; TAV-AI =113). Preoperative sinus of Valsalva dimensions were divided into 3 subgroups (less than 40 mm, 40-45 mm, and greater than 45 mm).

The mean patient age for patients with BAV and TAV was 59 years and 72 years (P less than .001), respectively (with 78% with BAV being men and 57% with TAV being men). There was a significantly higher subpopulation of AS in the BAV cohort vs. TAV-AS (70% vs. 35%; P less than .001).

With regard to SOV sizing, there was no significant difference in mean preoperative aortic root diameters between BAV and TAV cohorts for the AS or AI subpopulations.

In-hospital/30-day mortality was significantly higher in patients with TAV (5.2%) than in patients with BAV (1.6%, P = .033). In addition, the incidence of transient ischemic attack/stroke was significantly higher in the TAV group (3.4%) vs. the BAV group (0.8%, P = .04).

Valvular morphology and pathology at baseline, preoperative SOV diameter, postoperative time course, and interaction effect of preoperative SOV diameters and postoperative time course were used as covariates to assess outcomes. Within-subject and within–stratified subgroup comparison failed to show main effects across the follow-up times on postoperative SOV size patterns (P = .935), implying that the SOV trends were stable and sustained (discharge to greater than or equal to 10 years) irrespective of valvular morphology and pathology (BAV-AI, BAV-AS, TAV-AI, and TAV-AS).

Preoperative SOV dimensions significantly affected the retained postoperative sinus dimensions (P less than .001), according to Dr. Milewski and her colleagues.

The data indicated that an initial and pronounced postoperative decrease in SOV dimensions occurs with AVRSCAAR independently of aortic valve morphology, aortic valve pathology, and age, they added.

The 10-year freedom from aortic reoperation rates were 97% and 95% in the BAV and TAV subgroups, respectively. The BAV group had significantly improved reoperation-free survival, compared with the TAV group (P less than .001), while the type of valvular pathology within each group did not show a significant survival difference.

“Irrespective of the aortic valve morphology or valve pathology, in patients with mild to moderate aortic root dilatation (less than 45 mm), preservation of the SOV segment in the context of an AVRSCAAR procedure is justified. Continued further follow-up will be important to understand the long-term outcomes of sinus preservation, especially in the younger population with BAVs,” the researchers concluded.

The authors reported having no financial conflicts to disclose.

[email protected]

The sinus of Valsalva segment can be preserved during aortic valve replacement irrespective of the type of valve pathology, according to a recent study by Rita Karianna Milewski, MD, and her colleagues at the Hospital of the University of Pennsylvania, Philadelphia.

Severe aortic root dilation coupled to aortic valve disease requires root replacement in patients with a tricuspid or bicuspid aortic valve. Commonly, an aortic valve replacement and supracoronary ascending aorta replacement (AVRSCAAR) procedure has been used for patients who have a mild to moderately dilated sinus segment. One advantage of the procedure is that it retains the sinus of Valsalva (SOV) and preserves the intact coronary ostia.

However, the long-term behavior and risk of aortic events for the retained SOV in both BAV and TAV patients remains unclear, according to Dr. Milewski and her colleagues.

Previous researchers have suggested that patients with BAV and TAV have different rates of complications of the remaining aorta and dilation of the proximal aorta and retained sinus segment. In addition, it has been suggested that the cause of aortic dilation is different in patients with aortic stenosis (AS) and aortic insufficiency (AI) and is based on TAV and BAV morphology, histology, and hemodynamic flow patterns.

However, in the August issue of the Journal of Thoracic and Cardiovascular Surgery, Dr. Milewski and her colleagues reported on their study showing that, in patients with nonaneurysmal SOV undergoing AVRSCAAR, the sinus of Valsalva segment can be preserved regardless of the type of valvular pathology (aortic stenosis vs. aortic insufficiency) or valvular morphology (BAV vs. TAV).

The researchers retrospectively reviewed a prospectively maintained institutional database to stratify all patients by BAV or TAV valvular pathology with concomitant ascending aortic aneurysm who underwent an elective AVRSCAAR from 2002 to 2015 (J Thorac Cardiovasc Surg. 2017;154:421-32).

The distribution of the 428 patients meeting inclusion criteria by subgroups was: BAV group (254 patients: BAV-AS = 178; BAV-AI = 76); TAV group (174 patients: TAV-AS = 61; TAV-AI =113). Preoperative sinus of Valsalva dimensions were divided into 3 subgroups (less than 40 mm, 40-45 mm, and greater than 45 mm).

The mean patient age for patients with BAV and TAV was 59 years and 72 years (P less than .001), respectively (with 78% with BAV being men and 57% with TAV being men). There was a significantly higher subpopulation of AS in the BAV cohort vs. TAV-AS (70% vs. 35%; P less than .001).

With regard to SOV sizing, there was no significant difference in mean preoperative aortic root diameters between BAV and TAV cohorts for the AS or AI subpopulations.

In-hospital/30-day mortality was significantly higher in patients with TAV (5.2%) than in patients with BAV (1.6%, P = .033). In addition, the incidence of transient ischemic attack/stroke was significantly higher in the TAV group (3.4%) vs. the BAV group (0.8%, P = .04).

Valvular morphology and pathology at baseline, preoperative SOV diameter, postoperative time course, and interaction effect of preoperative SOV diameters and postoperative time course were used as covariates to assess outcomes. Within-subject and within–stratified subgroup comparison failed to show main effects across the follow-up times on postoperative SOV size patterns (P = .935), implying that the SOV trends were stable and sustained (discharge to greater than or equal to 10 years) irrespective of valvular morphology and pathology (BAV-AI, BAV-AS, TAV-AI, and TAV-AS).

Preoperative SOV dimensions significantly affected the retained postoperative sinus dimensions (P less than .001), according to Dr. Milewski and her colleagues.

The data indicated that an initial and pronounced postoperative decrease in SOV dimensions occurs with AVRSCAAR independently of aortic valve morphology, aortic valve pathology, and age, they added.

The 10-year freedom from aortic reoperation rates were 97% and 95% in the BAV and TAV subgroups, respectively. The BAV group had significantly improved reoperation-free survival, compared with the TAV group (P less than .001), while the type of valvular pathology within each group did not show a significant survival difference.

“Irrespective of the aortic valve morphology or valve pathology, in patients with mild to moderate aortic root dilatation (less than 45 mm), preservation of the SOV segment in the context of an AVRSCAAR procedure is justified. Continued further follow-up will be important to understand the long-term outcomes of sinus preservation, especially in the younger population with BAVs,” the researchers concluded.

The authors reported having no financial conflicts to disclose.

[email protected]

The sinus of Valsalva segment can be preserved during aortic valve replacement irrespective of the type of valve pathology, according to a recent study by Rita Karianna Milewski, MD, and her colleagues at the Hospital of the University of Pennsylvania, Philadelphia.

Severe aortic root dilation coupled to aortic valve disease requires root replacement in patients with a tricuspid or bicuspid aortic valve. Commonly, an aortic valve replacement and supracoronary ascending aorta replacement (AVRSCAAR) procedure has been used for patients who have a mild to moderately dilated sinus segment. One advantage of the procedure is that it retains the sinus of Valsalva (SOV) and preserves the intact coronary ostia.

However, the long-term behavior and risk of aortic events for the retained SOV in both BAV and TAV patients remains unclear, according to Dr. Milewski and her colleagues.

Previous researchers have suggested that patients with BAV and TAV have different rates of complications of the remaining aorta and dilation of the proximal aorta and retained sinus segment. In addition, it has been suggested that the cause of aortic dilation is different in patients with aortic stenosis (AS) and aortic insufficiency (AI) and is based on TAV and BAV morphology, histology, and hemodynamic flow patterns.

However, in the August issue of the Journal of Thoracic and Cardiovascular Surgery, Dr. Milewski and her colleagues reported on their study showing that, in patients with nonaneurysmal SOV undergoing AVRSCAAR, the sinus of Valsalva segment can be preserved regardless of the type of valvular pathology (aortic stenosis vs. aortic insufficiency) or valvular morphology (BAV vs. TAV).

The researchers retrospectively reviewed a prospectively maintained institutional database to stratify all patients by BAV or TAV valvular pathology with concomitant ascending aortic aneurysm who underwent an elective AVRSCAAR from 2002 to 2015 (J Thorac Cardiovasc Surg. 2017;154:421-32).

The distribution of the 428 patients meeting inclusion criteria by subgroups was: BAV group (254 patients: BAV-AS = 178; BAV-AI = 76); TAV group (174 patients: TAV-AS = 61; TAV-AI =113). Preoperative sinus of Valsalva dimensions were divided into 3 subgroups (less than 40 mm, 40-45 mm, and greater than 45 mm).

The mean patient age for patients with BAV and TAV was 59 years and 72 years (P less than .001), respectively (with 78% with BAV being men and 57% with TAV being men). There was a significantly higher subpopulation of AS in the BAV cohort vs. TAV-AS (70% vs. 35%; P less than .001).

With regard to SOV sizing, there was no significant difference in mean preoperative aortic root diameters between BAV and TAV cohorts for the AS or AI subpopulations.

In-hospital/30-day mortality was significantly higher in patients with TAV (5.2%) than in patients with BAV (1.6%, P = .033). In addition, the incidence of transient ischemic attack/stroke was significantly higher in the TAV group (3.4%) vs. the BAV group (0.8%, P = .04).

Valvular morphology and pathology at baseline, preoperative SOV diameter, postoperative time course, and interaction effect of preoperative SOV diameters and postoperative time course were used as covariates to assess outcomes. Within-subject and within–stratified subgroup comparison failed to show main effects across the follow-up times on postoperative SOV size patterns (P = .935), implying that the SOV trends were stable and sustained (discharge to greater than or equal to 10 years) irrespective of valvular morphology and pathology (BAV-AI, BAV-AS, TAV-AI, and TAV-AS).

Preoperative SOV dimensions significantly affected the retained postoperative sinus dimensions (P less than .001), according to Dr. Milewski and her colleagues.

The data indicated that an initial and pronounced postoperative decrease in SOV dimensions occurs with AVRSCAAR independently of aortic valve morphology, aortic valve pathology, and age, they added.

The 10-year freedom from aortic reoperation rates were 97% and 95% in the BAV and TAV subgroups, respectively. The BAV group had significantly improved reoperation-free survival, compared with the TAV group (P less than .001), while the type of valvular pathology within each group did not show a significant survival difference.

“Irrespective of the aortic valve morphology or valve pathology, in patients with mild to moderate aortic root dilatation (less than 45 mm), preservation of the SOV segment in the context of an AVRSCAAR procedure is justified. Continued further follow-up will be important to understand the long-term outcomes of sinus preservation, especially in the younger population with BAVs,” the researchers concluded.

The authors reported having no financial conflicts to disclose.

[email protected]

Obinutuzumab with CHOP therapy did not improve progression-free survival, compared with rituximab plus CHOP, in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to results from a phase 3 trial published in the Journal of Clinical Oncology. (2017 Aug 10. doi: 10.1200/JCO.2017.73.3402)

The findings suggest that obinutuzumab, a glycoengineered, type II, anti-CD20 monoclonal antibody, might not offer a benefit over standard treatment with rituximab, an anti-CD20 monoclonal antibody, when used with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone).

A total of 1,418 patients were enrolled at 207 centers in 29 countries in the GOYA trial and were randomly assigned to one regimen or the other. The mean duration of exposure to the drugs was 25 weeks for both. The progression-free survival was 69.6% for obinutuzumab-CHOP – also known as G-CHOP – and 66.9% for rituximab-CHOP, not a statistically significant difference, wrote Umberto Vitolo, MD, of University-Hospital Città della Salute e della Scienza, Torino, Italy, and his fellow investigators.

The rate of adverse events was similar between the two groups. The lack of superiority of obinutuzumab comes after findings of its superiority in untreated follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). The investigators suggested that this may be a sign that obinutuzumab’s efficacy is best seen in less aggressive disease types.

“Given the advantages of G-based therapy in patients with FL and CLL, the lack of benefit of G-CHOP in patients with DLBCL in the GOYA study was unexpected, and the reasons for it are unclear,” they wrote. “This lack of benefit might simply have resulted from the differences in biologic and clinical profiles between indolent lymphoproliferative diseases, such as FL and CLL, and aggressive ones, such as DLBCL.”

The study was sponsored by F. Hoffman-La Roche, the manufacturer of the two drugs, and had support from Fondazione Italiana Linfomi.

Obinutuzumab with CHOP therapy did not improve progression-free survival, compared with rituximab plus CHOP, in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to results from a phase 3 trial published in the Journal of Clinical Oncology. (2017 Aug 10. doi: 10.1200/JCO.2017.73.3402)

The findings suggest that obinutuzumab, a glycoengineered, type II, anti-CD20 monoclonal antibody, might not offer a benefit over standard treatment with rituximab, an anti-CD20 monoclonal antibody, when used with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone).

A total of 1,418 patients were enrolled at 207 centers in 29 countries in the GOYA trial and were randomly assigned to one regimen or the other. The mean duration of exposure to the drugs was 25 weeks for both. The progression-free survival was 69.6% for obinutuzumab-CHOP – also known as G-CHOP – and 66.9% for rituximab-CHOP, not a statistically significant difference, wrote Umberto Vitolo, MD, of University-Hospital Città della Salute e della Scienza, Torino, Italy, and his fellow investigators.

The rate of adverse events was similar between the two groups. The lack of superiority of obinutuzumab comes after findings of its superiority in untreated follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). The investigators suggested that this may be a sign that obinutuzumab’s efficacy is best seen in less aggressive disease types.

“Given the advantages of G-based therapy in patients with FL and CLL, the lack of benefit of G-CHOP in patients with DLBCL in the GOYA study was unexpected, and the reasons for it are unclear,” they wrote. “This lack of benefit might simply have resulted from the differences in biologic and clinical profiles between indolent lymphoproliferative diseases, such as FL and CLL, and aggressive ones, such as DLBCL.”

The study was sponsored by F. Hoffman-La Roche, the manufacturer of the two drugs, and had support from Fondazione Italiana Linfomi.

Obinutuzumab with CHOP therapy did not improve progression-free survival, compared with rituximab plus CHOP, in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to results from a phase 3 trial published in the Journal of Clinical Oncology. (2017 Aug 10. doi: 10.1200/JCO.2017.73.3402)

The findings suggest that obinutuzumab, a glycoengineered, type II, anti-CD20 monoclonal antibody, might not offer a benefit over standard treatment with rituximab, an anti-CD20 monoclonal antibody, when used with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone).

A total of 1,418 patients were enrolled at 207 centers in 29 countries in the GOYA trial and were randomly assigned to one regimen or the other. The mean duration of exposure to the drugs was 25 weeks for both. The progression-free survival was 69.6% for obinutuzumab-CHOP – also known as G-CHOP – and 66.9% for rituximab-CHOP, not a statistically significant difference, wrote Umberto Vitolo, MD, of University-Hospital Città della Salute e della Scienza, Torino, Italy, and his fellow investigators.

The rate of adverse events was similar between the two groups. The lack of superiority of obinutuzumab comes after findings of its superiority in untreated follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). The investigators suggested that this may be a sign that obinutuzumab’s efficacy is best seen in less aggressive disease types.

“Given the advantages of G-based therapy in patients with FL and CLL, the lack of benefit of G-CHOP in patients with DLBCL in the GOYA study was unexpected, and the reasons for it are unclear,” they wrote. “This lack of benefit might simply have resulted from the differences in biologic and clinical profiles between indolent lymphoproliferative diseases, such as FL and CLL, and aggressive ones, such as DLBCL.”

The study was sponsored by F. Hoffman-La Roche, the manufacturer of the two drugs, and had support from Fondazione Italiana Linfomi.

The Food and Drug Administration has approved the antibody drug conjugate inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The treatment, to be marketed by Pfizer as Besponsa, won approval based on the results of the INO-VATE ALL trial, which randomized 326 patients to receive either inotuzumab ozogamicin (164 patients) or a chemotherapy regimen of the investigator’s choice (162 patients). To be considered for inclusion in the trial, patients with Philadelphia chromosome–negative or –positive relapsed or refractory B-cell precursor ALL were required to have at least 5% bone marrow blasts and have received one or two induction chemotherapy regimens.

[email protected]

On Twitter @denisefulton

The Food and Drug Administration has approved the antibody drug conjugate inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The treatment, to be marketed by Pfizer as Besponsa, won approval based on the results of the INO-VATE ALL trial, which randomized 326 patients to receive either inotuzumab ozogamicin (164 patients) or a chemotherapy regimen of the investigator’s choice (162 patients). To be considered for inclusion in the trial, patients with Philadelphia chromosome–negative or –positive relapsed or refractory B-cell precursor ALL were required to have at least 5% bone marrow blasts and have received one or two induction chemotherapy regimens.

[email protected]

On Twitter @denisefulton

The Food and Drug Administration has approved the antibody drug conjugate inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The treatment, to be marketed by Pfizer as Besponsa, won approval based on the results of the INO-VATE ALL trial, which randomized 326 patients to receive either inotuzumab ozogamicin (164 patients) or a chemotherapy regimen of the investigator’s choice (162 patients). To be considered for inclusion in the trial, patients with Philadelphia chromosome–negative or –positive relapsed or refractory B-cell precursor ALL were required to have at least 5% bone marrow blasts and have received one or two induction chemotherapy regimens.

[email protected]

On Twitter @denisefulton

Standard care of chronic noncancer pain should start moving away from chronic opioid treatment, which can put patients in greater danger of developing a substance use disorder, according to evidence presented at a meeting held by the American Pain Society and Global Academy for Medical Education.

As the effects of the U.S. opioid epidemic continue to gain public attention – recently spurring a declaration of a state of emergency – physicians are looking for new methods to treat chronic pain responsibly without adding to the current number of opioid-related deaths.

Use of opioid therapy for pain conditions such as osteoarthritis, fibromyalgia, and migraine – once a common treatment approach – has been shown to be a dangerous breeding ground for opioid substance use disorders, and physicians would do well to re-evaluate their treatment methods, according to Edwin Salsitz, MD, assistant clinical professor at Mount Sinai Beth Israel Hospital, New York.

“Each prescriber is going to have to review this, digest it, reflect on it, and decide what they are going to do,” said Dr. Salsitz in an interview. “Base it on the Centers for Disease Control and Prevention’s guideline as a good starting point, and then individualize it for yourself and your patients.”

One of the major steps toward lowering the rate of opioid addiction through prescription is avoiding opioids as a treatment for acute pain.

“The first recommendation [of the CDC guideline] is nonpharmaceutical therapy, including physical therapy, massage therapy, acupuncture, and cognitive-behavioral therapy – and there’s a whole lot of evidence for these types of therapy,” said Dr. Salsitz. “The second option is that if you’re going to use medications, use those that aren’t opioids, like Tylenol, Motrin, and antidepressants.”

If opioids are necessary, said Dr. Salsitz, immediate-release opioids in limited prescriptions are a good way to lower the risk of addiction.

“The extended-release opioids have many more milligrams than the immediate-release opioids,” according to Dr. Salsitz. “For example, in New York state, we have a law now that says for acute pain, you cannot prescribe for more than a 7-day amount.”

That 7-day limit helps keep excess opioids out of households, he noted, making it harder for patients to share their medication with friends and family, which has proven to be the most common source for opioids during the onset of substance use disorders. In the first 12 months of use, friends and family members accounted for 55% of reported sources of opioids, according to the U.S. 2010 National Survey on Drug Use and Health.

Providers may also want to consider screening pain patients for psychological disorders, Dr. Salsitz said, as many psychological conditions are associated with a high risk of developing a substance use disorder. Patients with major depression, dysthymia, or panic disorder were 3.43, 6.51, and 5.37 times more likely, respectively, than those without to initiate a prescription for and regularly use opioids, according to a study cited by Dr. Salsitz (Arch Intern Med. 2006 Oct 23;166[19]:2087-93).

One of the largest barriers preventing providers from implementing these methods, however, is a lack of resources, particularly in rural areas with increasing rates of opioid substance use disorders and limited provider options.

While these limitations do pose a problem, physicians should not feel they can’t provide proper care, according to Dr. Salsitz. “I think that each individual provider, wherever they are located, can do a reasonable job.”

Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @eaztweets

Standard care of chronic noncancer pain should start moving away from chronic opioid treatment, which can put patients in greater danger of developing a substance use disorder, according to evidence presented at a meeting held by the American Pain Society and Global Academy for Medical Education.

As the effects of the U.S. opioid epidemic continue to gain public attention – recently spurring a declaration of a state of emergency – physicians are looking for new methods to treat chronic pain responsibly without adding to the current number of opioid-related deaths.

Use of opioid therapy for pain conditions such as osteoarthritis, fibromyalgia, and migraine – once a common treatment approach – has been shown to be a dangerous breeding ground for opioid substance use disorders, and physicians would do well to re-evaluate their treatment methods, according to Edwin Salsitz, MD, assistant clinical professor at Mount Sinai Beth Israel Hospital, New York.

“Each prescriber is going to have to review this, digest it, reflect on it, and decide what they are going to do,” said Dr. Salsitz in an interview. “Base it on the Centers for Disease Control and Prevention’s guideline as a good starting point, and then individualize it for yourself and your patients.”

One of the major steps toward lowering the rate of opioid addiction through prescription is avoiding opioids as a treatment for acute pain.

“The first recommendation [of the CDC guideline] is nonpharmaceutical therapy, including physical therapy, massage therapy, acupuncture, and cognitive-behavioral therapy – and there’s a whole lot of evidence for these types of therapy,” said Dr. Salsitz. “The second option is that if you’re going to use medications, use those that aren’t opioids, like Tylenol, Motrin, and antidepressants.”

If opioids are necessary, said Dr. Salsitz, immediate-release opioids in limited prescriptions are a good way to lower the risk of addiction.

“The extended-release opioids have many more milligrams than the immediate-release opioids,” according to Dr. Salsitz. “For example, in New York state, we have a law now that says for acute pain, you cannot prescribe for more than a 7-day amount.”

That 7-day limit helps keep excess opioids out of households, he noted, making it harder for patients to share their medication with friends and family, which has proven to be the most common source for opioids during the onset of substance use disorders. In the first 12 months of use, friends and family members accounted for 55% of reported sources of opioids, according to the U.S. 2010 National Survey on Drug Use and Health.

Providers may also want to consider screening pain patients for psychological disorders, Dr. Salsitz said, as many psychological conditions are associated with a high risk of developing a substance use disorder. Patients with major depression, dysthymia, or panic disorder were 3.43, 6.51, and 5.37 times more likely, respectively, than those without to initiate a prescription for and regularly use opioids, according to a study cited by Dr. Salsitz (Arch Intern Med. 2006 Oct 23;166[19]:2087-93).

One of the largest barriers preventing providers from implementing these methods, however, is a lack of resources, particularly in rural areas with increasing rates of opioid substance use disorders and limited provider options.

While these limitations do pose a problem, physicians should not feel they can’t provide proper care, according to Dr. Salsitz. “I think that each individual provider, wherever they are located, can do a reasonable job.”

Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @eaztweets

Standard care of chronic noncancer pain should start moving away from chronic opioid treatment, which can put patients in greater danger of developing a substance use disorder, according to evidence presented at a meeting held by the American Pain Society and Global Academy for Medical Education.

As the effects of the U.S. opioid epidemic continue to gain public attention – recently spurring a declaration of a state of emergency – physicians are looking for new methods to treat chronic pain responsibly without adding to the current number of opioid-related deaths.

Use of opioid therapy for pain conditions such as osteoarthritis, fibromyalgia, and migraine – once a common treatment approach – has been shown to be a dangerous breeding ground for opioid substance use disorders, and physicians would do well to re-evaluate their treatment methods, according to Edwin Salsitz, MD, assistant clinical professor at Mount Sinai Beth Israel Hospital, New York.

“Each prescriber is going to have to review this, digest it, reflect on it, and decide what they are going to do,” said Dr. Salsitz in an interview. “Base it on the Centers for Disease Control and Prevention’s guideline as a good starting point, and then individualize it for yourself and your patients.”

One of the major steps toward lowering the rate of opioid addiction through prescription is avoiding opioids as a treatment for acute pain.

“The first recommendation [of the CDC guideline] is nonpharmaceutical therapy, including physical therapy, massage therapy, acupuncture, and cognitive-behavioral therapy – and there’s a whole lot of evidence for these types of therapy,” said Dr. Salsitz. “The second option is that if you’re going to use medications, use those that aren’t opioids, like Tylenol, Motrin, and antidepressants.”

If opioids are necessary, said Dr. Salsitz, immediate-release opioids in limited prescriptions are a good way to lower the risk of addiction.

“The extended-release opioids have many more milligrams than the immediate-release opioids,” according to Dr. Salsitz. “For example, in New York state, we have a law now that says for acute pain, you cannot prescribe for more than a 7-day amount.”

That 7-day limit helps keep excess opioids out of households, he noted, making it harder for patients to share their medication with friends and family, which has proven to be the most common source for opioids during the onset of substance use disorders. In the first 12 months of use, friends and family members accounted for 55% of reported sources of opioids, according to the U.S. 2010 National Survey on Drug Use and Health.

Providers may also want to consider screening pain patients for psychological disorders, Dr. Salsitz said, as many psychological conditions are associated with a high risk of developing a substance use disorder. Patients with major depression, dysthymia, or panic disorder were 3.43, 6.51, and 5.37 times more likely, respectively, than those without to initiate a prescription for and regularly use opioids, according to a study cited by Dr. Salsitz (Arch Intern Med. 2006 Oct 23;166[19]:2087-93).

One of the largest barriers preventing providers from implementing these methods, however, is a lack of resources, particularly in rural areas with increasing rates of opioid substance use disorders and limited provider options.

While these limitations do pose a problem, physicians should not feel they can’t provide proper care, according to Dr. Salsitz. “I think that each individual provider, wherever they are located, can do a reasonable job.”

Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @eaztweets

Among psoriatic arthritis (PsA) patients who started a systemic disease-modifying antirheumatic drug (DMARD) in the United States during 2004-2015, treatment modification rates went up and discontinuation rates decreased over the 11-year period, according to results from a large study of national claims data.

The increased rate of treatment modification may not be surprising given the “significant advancement in PsA treatment and expanding pharmacotherapy options in the past decade,” wrote researchers led by Moa P. Lee, PharmD, of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital and Harvard Medical School, Boston (Arthritis Care Res. 2017 Aug 13. doi: 10.1002/acr.23337).

The researchers reviewed records between July 1, 2004, and Sept. 30, 2015, from the Clinformatics Datamart data set, which contains demographic and longitudinal claims information for all United Healthcare beneficiaries. They observed an increasing trend in treatment modifications over the 11-year study period (P = .03) and found that 5% of all patients discontinued treatment, with the discontinuation rates decreasing over time (P less than .001).

Of the 9,222 PsA patients who initiated DMARDs, 43% received a biologic agent (bDMARD) and 57% received a conventional synthetic agent (csDMARD). Patients who were initiated on bDMARDs had an average age of 48 years, compared with 52 years in csDMARD initiators. Biologic DMARD initiators also had generally fewer comorbidities.

The most frequently used DMARD overall was methotrexate, which constituted 81% of csDMARD initiations. The most commonly prescribed bDMARDs were etanercept and adalimumab (49% vs. 34%, respectively).

When the researchers evaluated 12-month follow-up data after the first DMARD initiation, they found that 20% of bDMARD initiators had their initial DMARD regimen modified, compared with 31% of csDMARD initiators. Treatment modifications occurred more quickly after starting a csDMARD (median of 102 days) when compared against bDMARD initiators (148 days), and the rate of modification was also higher for patients who first started a csDMARD (adjusted incidence rate of 39.3 cases per 100 patient-years vs. 21.1 cases per 100 person-years for bDMARDs).

The most common modification made by csDMARD initiators was the addition of a bDMARD to methotrexate, particularly etanercept or adalimumab, in 16%. For bDMARD initiators, the most common modification was adding methotrexate in 7%, followed by switches between etanercept and adalimumab in 6%.

“In a rapidly evolving field of PsA treatment, further studies that elucidate more comprehensive real-world trends in the use of available treatment, including more recent novel therapies for PsA, may be needed,” the researchers concluded.

There was no specific funding source for the study. The researchers reported having no financial disclosures relevant to the study.

[email protected]

Among psoriatic arthritis (PsA) patients who started a systemic disease-modifying antirheumatic drug (DMARD) in the United States during 2004-2015, treatment modification rates went up and discontinuation rates decreased over the 11-year period, according to results from a large study of national claims data.

The increased rate of treatment modification may not be surprising given the “significant advancement in PsA treatment and expanding pharmacotherapy options in the past decade,” wrote researchers led by Moa P. Lee, PharmD, of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital and Harvard Medical School, Boston (Arthritis Care Res. 2017 Aug 13. doi: 10.1002/acr.23337).

The researchers reviewed records between July 1, 2004, and Sept. 30, 2015, from the Clinformatics Datamart data set, which contains demographic and longitudinal claims information for all United Healthcare beneficiaries. They observed an increasing trend in treatment modifications over the 11-year study period (P = .03) and found that 5% of all patients discontinued treatment, with the discontinuation rates decreasing over time (P less than .001).

Of the 9,222 PsA patients who initiated DMARDs, 43% received a biologic agent (bDMARD) and 57% received a conventional synthetic agent (csDMARD). Patients who were initiated on bDMARDs had an average age of 48 years, compared with 52 years in csDMARD initiators. Biologic DMARD initiators also had generally fewer comorbidities.

The most frequently used DMARD overall was methotrexate, which constituted 81% of csDMARD initiations. The most commonly prescribed bDMARDs were etanercept and adalimumab (49% vs. 34%, respectively).

When the researchers evaluated 12-month follow-up data after the first DMARD initiation, they found that 20% of bDMARD initiators had their initial DMARD regimen modified, compared with 31% of csDMARD initiators. Treatment modifications occurred more quickly after starting a csDMARD (median of 102 days) when compared against bDMARD initiators (148 days), and the rate of modification was also higher for patients who first started a csDMARD (adjusted incidence rate of 39.3 cases per 100 patient-years vs. 21.1 cases per 100 person-years for bDMARDs).

The most common modification made by csDMARD initiators was the addition of a bDMARD to methotrexate, particularly etanercept or adalimumab, in 16%. For bDMARD initiators, the most common modification was adding methotrexate in 7%, followed by switches between etanercept and adalimumab in 6%.

“In a rapidly evolving field of PsA treatment, further studies that elucidate more comprehensive real-world trends in the use of available treatment, including more recent novel therapies for PsA, may be needed,” the researchers concluded.

There was no specific funding source for the study. The researchers reported having no financial disclosures relevant to the study.

[email protected]

Among psoriatic arthritis (PsA) patients who started a systemic disease-modifying antirheumatic drug (DMARD) in the United States during 2004-2015, treatment modification rates went up and discontinuation rates decreased over the 11-year period, according to results from a large study of national claims data.

The increased rate of treatment modification may not be surprising given the “significant advancement in PsA treatment and expanding pharmacotherapy options in the past decade,” wrote researchers led by Moa P. Lee, PharmD, of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital and Harvard Medical School, Boston (Arthritis Care Res. 2017 Aug 13. doi: 10.1002/acr.23337).

The researchers reviewed records between July 1, 2004, and Sept. 30, 2015, from the Clinformatics Datamart data set, which contains demographic and longitudinal claims information for all United Healthcare beneficiaries. They observed an increasing trend in treatment modifications over the 11-year study period (P = .03) and found that 5% of all patients discontinued treatment, with the discontinuation rates decreasing over time (P less than .001).

Of the 9,222 PsA patients who initiated DMARDs, 43% received a biologic agent (bDMARD) and 57% received a conventional synthetic agent (csDMARD). Patients who were initiated on bDMARDs had an average age of 48 years, compared with 52 years in csDMARD initiators. Biologic DMARD initiators also had generally fewer comorbidities.

The most frequently used DMARD overall was methotrexate, which constituted 81% of csDMARD initiations. The most commonly prescribed bDMARDs were etanercept and adalimumab (49% vs. 34%, respectively).

When the researchers evaluated 12-month follow-up data after the first DMARD initiation, they found that 20% of bDMARD initiators had their initial DMARD regimen modified, compared with 31% of csDMARD initiators. Treatment modifications occurred more quickly after starting a csDMARD (median of 102 days) when compared against bDMARD initiators (148 days), and the rate of modification was also higher for patients who first started a csDMARD (adjusted incidence rate of 39.3 cases per 100 patient-years vs. 21.1 cases per 100 person-years for bDMARDs).

The most common modification made by csDMARD initiators was the addition of a bDMARD to methotrexate, particularly etanercept or adalimumab, in 16%. For bDMARD initiators, the most common modification was adding methotrexate in 7%, followed by switches between etanercept and adalimumab in 6%.

“In a rapidly evolving field of PsA treatment, further studies that elucidate more comprehensive real-world trends in the use of available treatment, including more recent novel therapies for PsA, may be needed,” the researchers concluded.

There was no specific funding source for the study. The researchers reported having no financial disclosures relevant to the study.

[email protected]