News

Pre-exposure prophylaxis ( PrEP)—just 1 pill every day—can reduce the risk HIV infection by > 90%. A recent study shows that > 40% of chlamydia infections and 42% of gonorrhea infections also could be prevented over the next decade if 40% of homosexual and bisexual men took PrEP for HIV and were tested and treated every 6 months.

The CDC estimates that nearly 500,000 men are at “substantial risk” for HIV infection and could benefit from PrEP. But recent evidence suggests that some men may use condoms less when they are taking PrEP. According to researchers from the CDC and The Rollins School of Public Health at Emory University, PrEP prevented some STIs even with a 40% reduction in condom use.

The CDC recommends testing patients who use PrEP for bacterial STIs at least once every 6 months even if they don’t have symptoms. The study found that increasing STI testing from twice a year to 4 times a year would not dramatically affect the prevention of chlamydia or gonorrhea.

PrEP’s effectiveness in preventing HIV is well documented, the CDC says. The new study shows the “potential impact” that following the CDC’s clinical guidelines for PrEP can have on preventing bacterial STIs as well. But about one third of primary health care providers had not heard of PrEP as recently as 2015, the CDC says. To address that need, the CDC has been leading education efforts targeting providers, offering the guidelines, step-by-step PrEP checklists, and interview guides, along with a hotline to answer providers’ questions about when and how to offer PrEP.

Pre-exposure prophylaxis ( PrEP)—just 1 pill every day—can reduce the risk HIV infection by > 90%. A recent study shows that > 40% of chlamydia infections and 42% of gonorrhea infections also could be prevented over the next decade if 40% of homosexual and bisexual men took PrEP for HIV and were tested and treated every 6 months.

The CDC estimates that nearly 500,000 men are at “substantial risk” for HIV infection and could benefit from PrEP. But recent evidence suggests that some men may use condoms less when they are taking PrEP. According to researchers from the CDC and The Rollins School of Public Health at Emory University, PrEP prevented some STIs even with a 40% reduction in condom use.

The CDC recommends testing patients who use PrEP for bacterial STIs at least once every 6 months even if they don’t have symptoms. The study found that increasing STI testing from twice a year to 4 times a year would not dramatically affect the prevention of chlamydia or gonorrhea.

PrEP’s effectiveness in preventing HIV is well documented, the CDC says. The new study shows the “potential impact” that following the CDC’s clinical guidelines for PrEP can have on preventing bacterial STIs as well. But about one third of primary health care providers had not heard of PrEP as recently as 2015, the CDC says. To address that need, the CDC has been leading education efforts targeting providers, offering the guidelines, step-by-step PrEP checklists, and interview guides, along with a hotline to answer providers’ questions about when and how to offer PrEP.

Pre-exposure prophylaxis ( PrEP)—just 1 pill every day—can reduce the risk HIV infection by > 90%. A recent study shows that > 40% of chlamydia infections and 42% of gonorrhea infections also could be prevented over the next decade if 40% of homosexual and bisexual men took PrEP for HIV and were tested and treated every 6 months.

The CDC estimates that nearly 500,000 men are at “substantial risk” for HIV infection and could benefit from PrEP. But recent evidence suggests that some men may use condoms less when they are taking PrEP. According to researchers from the CDC and The Rollins School of Public Health at Emory University, PrEP prevented some STIs even with a 40% reduction in condom use.

The CDC recommends testing patients who use PrEP for bacterial STIs at least once every 6 months even if they don’t have symptoms. The study found that increasing STI testing from twice a year to 4 times a year would not dramatically affect the prevention of chlamydia or gonorrhea.

PrEP’s effectiveness in preventing HIV is well documented, the CDC says. The new study shows the “potential impact” that following the CDC’s clinical guidelines for PrEP can have on preventing bacterial STIs as well. But about one third of primary health care providers had not heard of PrEP as recently as 2015, the CDC says. To address that need, the CDC has been leading education efforts targeting providers, offering the guidelines, step-by-step PrEP checklists, and interview guides, along with a hotline to answer providers’ questions about when and how to offer PrEP.

With optimal approaches still evolving for the diagnosis and management of peripheral neuropathies associated with Waldenström macroglobulinemia and other IgM paraproteinemias, new consensus recommendations from a multidisciplinary panel were recently published in the British Journal of Haematology.

Up to half of patients with IgM monoclonal gammopathies develop peripheral neuropathy, according to the 11-member panel (Br J Haematol. 2017 Mar;176[5]:728-42). The panel began deliberations at the eighth International Workshop on Waldenström Macroglobulinemia in London and was led by Shirley D’Sa, MD, of the Waldenström Clinic, Cancer Division, University College London Hospitals NHS Foundation Trust.

• Diagnostic evaluation: “The indications for invasive investigations such as cerebrospinal fluid analysis, nerve conduction tests, and sensory nerve biopsies are unclear,” according to the panelists.

When clinical examination identifies a neuropathy, neurophysiologic testing can ascertain its nature and inform additional work-up. Cerebrospinal fluid examination is not mandatory in cases of demyelinating neuropathy, but it is indicated when clinical evaluation is inconclusive and malignancy or CNS invasion is suspected.

Nerve biopsy carries substantial risk and is rarely indicated. It may be warranted when a comprehensive systemic work-up has not identified a cause and clinicians still suspect amyloid, vasculitis, or direct cellular invasion; in atypical cases not responding to treatment; or when the neuropathy is progressive and debilitating.

When it comes to imaging, “MRI of the neuraxis should be performed prior to lumbar puncture to avoid false positive meningeal enhancement,” they advised. “Prior discussion of likely sites of involvement with an experienced neuroradiologist will ensure that the correct sequences of the correct anatomical area are performed with appropriate gadolinium enhancement.”

• Clinical phenotypes and their treatment: IgM-associated neuropathies vary with respect to specific antibodies present and the likelihood that they are causally associated with the neuropathy, Dr. D’Sa and her colleagues noted. They provided a decision tree to help guide the work-up to determine the specific etiology.

“The presence of a neuropathy alone is not a justification for treatment, but steady progression with accumulating disability should prompt action,” they maintained.

Patients with antibody-negative peripheral neuropathy associated with IgM monoclonal gammopathies of undetermined significance who have mild disease and no hematologic reason for treatment can be managed with surveillance, according to the panelists.

However, immunosuppressive or immunomodulatory treatment should be considered when there is substantial or progressive disability associated with demyelination.

Patients with anti-MAG (myelin-associated glycoprotein) demyelinating neuropathy may benefit from rituximab (Rituxan). In those with more advanced disease, clinicians should consider immunosuppressive or immunomodulatory treatment instead.

Surveillance is also an option for Waldenström macroglobulinemia–associated peripheral neuropathy that is progressing slowly. When used, treatment should be tailored to severity of both systemic and neurologic disease.
 

• Treatment response assessment: “The optimum way to measure clinical response to treatment unknown,” Dr. D’Sa and her fellow panelists noted. A variety of measures of muscle strength, sensory function, and disability are used.

“The I-RODS [Inflammatory Rasch-Built Overall Disability Scale] more often captures clinically meaningful changes over time, with a greater magnitude of change, compared with the INCAT-ONLS [Inflammatory Neuropathy Cause and Treatment–Overall Neuropathy Limitation Scale] disability scale and its use is therefore suggested in future trials involving patients with inflammatory neuropathies,” they wrote.

• Model of care: Management of patients with IgM-associated neuropathies requires multidisciplinary care with good collaboration to optimize patient outcomes, the consensus panel said.

“A suggested model of care is a combined neurological and hematological clinic, in which patients are seen jointly by a specialist neurologist and hematologist and a decision can be made about the sequence of investigations, interventions, and the formulation of a treatment plan,” they proposed. “Appropriate and timely referral to physical, occupational, and orthotic professionals is recommended in order to maximize safety and function.”

• Future perspectives: “There is much to be done to improve outcomes for patients with IgM and [Waldenström macroglobulinemia]-associated peripheral neuropathies,” the panelists concluded.

Key areas of focus are “early recognition of the problem, appropriate causal attribution achieved through sensitive diagnostics that are not overly invasive, timely therapeutic intervention with effective and nonneurotoxic therapies, achievement of an appropriate degree of clonal reduction for optimum clinical outcomes, and the use of reproducible and readily applicable tools to measure outcomes.”

Dr. D’Sa disclosed that she receives honoraria from Janssen.

With optimal approaches still evolving for the diagnosis and management of peripheral neuropathies associated with Waldenström macroglobulinemia and other IgM paraproteinemias, new consensus recommendations from a multidisciplinary panel were recently published in the British Journal of Haematology.

Up to half of patients with IgM monoclonal gammopathies develop peripheral neuropathy, according to the 11-member panel (Br J Haematol. 2017 Mar;176[5]:728-42). The panel began deliberations at the eighth International Workshop on Waldenström Macroglobulinemia in London and was led by Shirley D’Sa, MD, of the Waldenström Clinic, Cancer Division, University College London Hospitals NHS Foundation Trust.

• Diagnostic evaluation: “The indications for invasive investigations such as cerebrospinal fluid analysis, nerve conduction tests, and sensory nerve biopsies are unclear,” according to the panelists.

When clinical examination identifies a neuropathy, neurophysiologic testing can ascertain its nature and inform additional work-up. Cerebrospinal fluid examination is not mandatory in cases of demyelinating neuropathy, but it is indicated when clinical evaluation is inconclusive and malignancy or CNS invasion is suspected.

Nerve biopsy carries substantial risk and is rarely indicated. It may be warranted when a comprehensive systemic work-up has not identified a cause and clinicians still suspect amyloid, vasculitis, or direct cellular invasion; in atypical cases not responding to treatment; or when the neuropathy is progressive and debilitating.

When it comes to imaging, “MRI of the neuraxis should be performed prior to lumbar puncture to avoid false positive meningeal enhancement,” they advised. “Prior discussion of likely sites of involvement with an experienced neuroradiologist will ensure that the correct sequences of the correct anatomical area are performed with appropriate gadolinium enhancement.”

• Clinical phenotypes and their treatment: IgM-associated neuropathies vary with respect to specific antibodies present and the likelihood that they are causally associated with the neuropathy, Dr. D’Sa and her colleagues noted. They provided a decision tree to help guide the work-up to determine the specific etiology.

“The presence of a neuropathy alone is not a justification for treatment, but steady progression with accumulating disability should prompt action,” they maintained.

Patients with antibody-negative peripheral neuropathy associated with IgM monoclonal gammopathies of undetermined significance who have mild disease and no hematologic reason for treatment can be managed with surveillance, according to the panelists.

However, immunosuppressive or immunomodulatory treatment should be considered when there is substantial or progressive disability associated with demyelination.

Patients with anti-MAG (myelin-associated glycoprotein) demyelinating neuropathy may benefit from rituximab (Rituxan). In those with more advanced disease, clinicians should consider immunosuppressive or immunomodulatory treatment instead.

Surveillance is also an option for Waldenström macroglobulinemia–associated peripheral neuropathy that is progressing slowly. When used, treatment should be tailored to severity of both systemic and neurologic disease.
 

• Treatment response assessment: “The optimum way to measure clinical response to treatment unknown,” Dr. D’Sa and her fellow panelists noted. A variety of measures of muscle strength, sensory function, and disability are used.

“The I-RODS [Inflammatory Rasch-Built Overall Disability Scale] more often captures clinically meaningful changes over time, with a greater magnitude of change, compared with the INCAT-ONLS [Inflammatory Neuropathy Cause and Treatment–Overall Neuropathy Limitation Scale] disability scale and its use is therefore suggested in future trials involving patients with inflammatory neuropathies,” they wrote.

• Model of care: Management of patients with IgM-associated neuropathies requires multidisciplinary care with good collaboration to optimize patient outcomes, the consensus panel said.

“A suggested model of care is a combined neurological and hematological clinic, in which patients are seen jointly by a specialist neurologist and hematologist and a decision can be made about the sequence of investigations, interventions, and the formulation of a treatment plan,” they proposed. “Appropriate and timely referral to physical, occupational, and orthotic professionals is recommended in order to maximize safety and function.”

• Future perspectives: “There is much to be done to improve outcomes for patients with IgM and [Waldenström macroglobulinemia]-associated peripheral neuropathies,” the panelists concluded.

Key areas of focus are “early recognition of the problem, appropriate causal attribution achieved through sensitive diagnostics that are not overly invasive, timely therapeutic intervention with effective and nonneurotoxic therapies, achievement of an appropriate degree of clonal reduction for optimum clinical outcomes, and the use of reproducible and readily applicable tools to measure outcomes.”

Dr. D’Sa disclosed that she receives honoraria from Janssen.

With optimal approaches still evolving for the diagnosis and management of peripheral neuropathies associated with Waldenström macroglobulinemia and other IgM paraproteinemias, new consensus recommendations from a multidisciplinary panel were recently published in the British Journal of Haematology.

Up to half of patients with IgM monoclonal gammopathies develop peripheral neuropathy, according to the 11-member panel (Br J Haematol. 2017 Mar;176[5]:728-42). The panel began deliberations at the eighth International Workshop on Waldenström Macroglobulinemia in London and was led by Shirley D’Sa, MD, of the Waldenström Clinic, Cancer Division, University College London Hospitals NHS Foundation Trust.

• Diagnostic evaluation: “The indications for invasive investigations such as cerebrospinal fluid analysis, nerve conduction tests, and sensory nerve biopsies are unclear,” according to the panelists.

When clinical examination identifies a neuropathy, neurophysiologic testing can ascertain its nature and inform additional work-up. Cerebrospinal fluid examination is not mandatory in cases of demyelinating neuropathy, but it is indicated when clinical evaluation is inconclusive and malignancy or CNS invasion is suspected.

Nerve biopsy carries substantial risk and is rarely indicated. It may be warranted when a comprehensive systemic work-up has not identified a cause and clinicians still suspect amyloid, vasculitis, or direct cellular invasion; in atypical cases not responding to treatment; or when the neuropathy is progressive and debilitating.

When it comes to imaging, “MRI of the neuraxis should be performed prior to lumbar puncture to avoid false positive meningeal enhancement,” they advised. “Prior discussion of likely sites of involvement with an experienced neuroradiologist will ensure that the correct sequences of the correct anatomical area are performed with appropriate gadolinium enhancement.”

• Clinical phenotypes and their treatment: IgM-associated neuropathies vary with respect to specific antibodies present and the likelihood that they are causally associated with the neuropathy, Dr. D’Sa and her colleagues noted. They provided a decision tree to help guide the work-up to determine the specific etiology.

“The presence of a neuropathy alone is not a justification for treatment, but steady progression with accumulating disability should prompt action,” they maintained.

Patients with antibody-negative peripheral neuropathy associated with IgM monoclonal gammopathies of undetermined significance who have mild disease and no hematologic reason for treatment can be managed with surveillance, according to the panelists.

However, immunosuppressive or immunomodulatory treatment should be considered when there is substantial or progressive disability associated with demyelination.

Patients with anti-MAG (myelin-associated glycoprotein) demyelinating neuropathy may benefit from rituximab (Rituxan). In those with more advanced disease, clinicians should consider immunosuppressive or immunomodulatory treatment instead.

Surveillance is also an option for Waldenström macroglobulinemia–associated peripheral neuropathy that is progressing slowly. When used, treatment should be tailored to severity of both systemic and neurologic disease.
 

• Treatment response assessment: “The optimum way to measure clinical response to treatment unknown,” Dr. D’Sa and her fellow panelists noted. A variety of measures of muscle strength, sensory function, and disability are used.

“The I-RODS [Inflammatory Rasch-Built Overall Disability Scale] more often captures clinically meaningful changes over time, with a greater magnitude of change, compared with the INCAT-ONLS [Inflammatory Neuropathy Cause and Treatment–Overall Neuropathy Limitation Scale] disability scale and its use is therefore suggested in future trials involving patients with inflammatory neuropathies,” they wrote.

• Model of care: Management of patients with IgM-associated neuropathies requires multidisciplinary care with good collaboration to optimize patient outcomes, the consensus panel said.

“A suggested model of care is a combined neurological and hematological clinic, in which patients are seen jointly by a specialist neurologist and hematologist and a decision can be made about the sequence of investigations, interventions, and the formulation of a treatment plan,” they proposed. “Appropriate and timely referral to physical, occupational, and orthotic professionals is recommended in order to maximize safety and function.”

• Future perspectives: “There is much to be done to improve outcomes for patients with IgM and [Waldenström macroglobulinemia]-associated peripheral neuropathies,” the panelists concluded.

Key areas of focus are “early recognition of the problem, appropriate causal attribution achieved through sensitive diagnostics that are not overly invasive, timely therapeutic intervention with effective and nonneurotoxic therapies, achievement of an appropriate degree of clonal reduction for optimum clinical outcomes, and the use of reproducible and readily applicable tools to measure outcomes.”

Dr. D’Sa disclosed that she receives honoraria from Janssen.

This should not come as much of a surprise, but health care made the top-5 list of occupations whose workers are getting too little sleep, according to a study by The National Institute for Occupational Safety and Health (NIOSH) researchers.

The researchers analyzed data from 179,621 working adults who responded to the 2013 or 2014 Behavior Risk Factor Surveillance System annual surveys. Among the 22 major occupation groups, health care support (40.1%) and health care practitioners and technical (40.0%) ranked second and third in “short sleep duration,” after production (42.9%). Among the occupational subgroups, nursing, psychiatric, and home health aides had a high adjusted prevalence of short sleep duration.

Workers in occupations where alternative shiftwork is common were more likely to have a higher adjusted prevalence of short sleep duration.  More than 35% of health care practitioners work shifts. Workers in other occupation groups such as teachers, farmers, or pilots, were more likely to report getting enough sleep.

Time at work also is on the rise in the US where workers have the longest annual working hours among workers in all wealthy industrialized countries, which reduces the time available for sleep, NIOSH says. The researchers point out that lack of sleep has been linked to negative health outcomes including cardiovascular disease, obesity, and depression, as well as safety issues related to drowsy driving and injuries.

To help people get more sleep or improve the quality of the sleep they get, NIOSH offers training and resources about sleep, shiftwork, and fatigue for a variety of audiences including health care workers and emergency responders. Free downloadable materials are available at www.cdc.gov/niosh/topics/workschedules/education.html.

This should not come as much of a surprise, but health care made the top-5 list of occupations whose workers are getting too little sleep, according to a study by The National Institute for Occupational Safety and Health (NIOSH) researchers.

The researchers analyzed data from 179,621 working adults who responded to the 2013 or 2014 Behavior Risk Factor Surveillance System annual surveys. Among the 22 major occupation groups, health care support (40.1%) and health care practitioners and technical (40.0%) ranked second and third in “short sleep duration,” after production (42.9%). Among the occupational subgroups, nursing, psychiatric, and home health aides had a high adjusted prevalence of short sleep duration.

Workers in occupations where alternative shiftwork is common were more likely to have a higher adjusted prevalence of short sleep duration.  More than 35% of health care practitioners work shifts. Workers in other occupation groups such as teachers, farmers, or pilots, were more likely to report getting enough sleep.

Time at work also is on the rise in the US where workers have the longest annual working hours among workers in all wealthy industrialized countries, which reduces the time available for sleep, NIOSH says. The researchers point out that lack of sleep has been linked to negative health outcomes including cardiovascular disease, obesity, and depression, as well as safety issues related to drowsy driving and injuries.

To help people get more sleep or improve the quality of the sleep they get, NIOSH offers training and resources about sleep, shiftwork, and fatigue for a variety of audiences including health care workers and emergency responders. Free downloadable materials are available at www.cdc.gov/niosh/topics/workschedules/education.html.

This should not come as much of a surprise, but health care made the top-5 list of occupations whose workers are getting too little sleep, according to a study by The National Institute for Occupational Safety and Health (NIOSH) researchers.

The researchers analyzed data from 179,621 working adults who responded to the 2013 or 2014 Behavior Risk Factor Surveillance System annual surveys. Among the 22 major occupation groups, health care support (40.1%) and health care practitioners and technical (40.0%) ranked second and third in “short sleep duration,” after production (42.9%). Among the occupational subgroups, nursing, psychiatric, and home health aides had a high adjusted prevalence of short sleep duration.

Workers in occupations where alternative shiftwork is common were more likely to have a higher adjusted prevalence of short sleep duration.  More than 35% of health care practitioners work shifts. Workers in other occupation groups such as teachers, farmers, or pilots, were more likely to report getting enough sleep.

Time at work also is on the rise in the US where workers have the longest annual working hours among workers in all wealthy industrialized countries, which reduces the time available for sleep, NIOSH says. The researchers point out that lack of sleep has been linked to negative health outcomes including cardiovascular disease, obesity, and depression, as well as safety issues related to drowsy driving and injuries.

To help people get more sleep or improve the quality of the sleep they get, NIOSH offers training and resources about sleep, shiftwork, and fatigue for a variety of audiences including health care workers and emergency responders. Free downloadable materials are available at www.cdc.gov/niosh/topics/workschedules/education.html.

NEW YORK – Does obinutuzumab have a leg up over rituximab for treating follicular lymphoma?

A strict reading of the efficacy records of the two anti-CD20 antibodies when they went head-to-head suggests that obinutuzumab (Gazyva) edged out rituximab (Rituxan), but a broader view leaves the door open for rituximab as a still viable option depending on a patient’s status and priorities, experts said at the conference held by Imedex.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

NEW YORK – Does obinutuzumab have a leg up over rituximab for treating follicular lymphoma?

A strict reading of the efficacy records of the two anti-CD20 antibodies when they went head-to-head suggests that obinutuzumab (Gazyva) edged out rituximab (Rituxan), but a broader view leaves the door open for rituximab as a still viable option depending on a patient’s status and priorities, experts said at the conference held by Imedex.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

NEW YORK – Does obinutuzumab have a leg up over rituximab for treating follicular lymphoma?

A strict reading of the efficacy records of the two anti-CD20 antibodies when they went head-to-head suggests that obinutuzumab (Gazyva) edged out rituximab (Rituxan), but a broader view leaves the door open for rituximab as a still viable option depending on a patient’s status and priorities, experts said at the conference held by Imedex.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

A recommendation on postop adjuvant chemotherapy has been updated in the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline, according to an article published online on April 11 in the Journal of Clinical Oncology.

In the absence of medical or surgical contraindications, all patients who have resected pancreatic cancer and did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy, according to the new recommendation. “The doublet regimen of gemcitabine and capecitabine is preferred in the absence of concerns for toxicity or tolerance; alternatively, monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery,” Alok A. Khorana, MD, of the Cleveland Clinic, and members of the guideline committee wrote.

The recommendation was based on results of the ESPAC-4 study, a multicenter, international, open-label randomized controlled phase III trial (Lancet. 2017;389:1011-24). ESPAC-4 compared adjuvant combination chemotherapy of gemcitabine and capecitabine with gemcitabine monotherapy in 730 evaluable patients with resected pancreatic ductal adenocarcinoma.

Median overall survival was 28 months (95% confidence interval, 23.5-31.5 months) in the doublet arm and 25.5 months (95% CI, 22.7 to 27.9 months) for gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68-0.98; P = .032). Grade 3 and 4 adverse events were similar in both arms, although higher rates of hand-foot syndrome and diarrhea occurred in patients randomly assigned to the doublet arm.

The remaining recommendations from the original 2016 ASCO guideline are unchanged.

The revised guideline is available at this link.

mdales@frontlinemedcom.com

On Twitter @maryjodales

A recommendation on postop adjuvant chemotherapy has been updated in the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline, according to an article published online on April 11 in the Journal of Clinical Oncology.

In the absence of medical or surgical contraindications, all patients who have resected pancreatic cancer and did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy, according to the new recommendation. “The doublet regimen of gemcitabine and capecitabine is preferred in the absence of concerns for toxicity or tolerance; alternatively, monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery,” Alok A. Khorana, MD, of the Cleveland Clinic, and members of the guideline committee wrote.

The recommendation was based on results of the ESPAC-4 study, a multicenter, international, open-label randomized controlled phase III trial (Lancet. 2017;389:1011-24). ESPAC-4 compared adjuvant combination chemotherapy of gemcitabine and capecitabine with gemcitabine monotherapy in 730 evaluable patients with resected pancreatic ductal adenocarcinoma.

Median overall survival was 28 months (95% confidence interval, 23.5-31.5 months) in the doublet arm and 25.5 months (95% CI, 22.7 to 27.9 months) for gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68-0.98; P = .032). Grade 3 and 4 adverse events were similar in both arms, although higher rates of hand-foot syndrome and diarrhea occurred in patients randomly assigned to the doublet arm.

The remaining recommendations from the original 2016 ASCO guideline are unchanged.

The revised guideline is available at this link.

mdales@frontlinemedcom.com

On Twitter @maryjodales

A recommendation on postop adjuvant chemotherapy has been updated in the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline, according to an article published online on April 11 in the Journal of Clinical Oncology.

In the absence of medical or surgical contraindications, all patients who have resected pancreatic cancer and did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy, according to the new recommendation. “The doublet regimen of gemcitabine and capecitabine is preferred in the absence of concerns for toxicity or tolerance; alternatively, monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery,” Alok A. Khorana, MD, of the Cleveland Clinic, and members of the guideline committee wrote.

The recommendation was based on results of the ESPAC-4 study, a multicenter, international, open-label randomized controlled phase III trial (Lancet. 2017;389:1011-24). ESPAC-4 compared adjuvant combination chemotherapy of gemcitabine and capecitabine with gemcitabine monotherapy in 730 evaluable patients with resected pancreatic ductal adenocarcinoma.

Median overall survival was 28 months (95% confidence interval, 23.5-31.5 months) in the doublet arm and 25.5 months (95% CI, 22.7 to 27.9 months) for gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68-0.98; P = .032). Grade 3 and 4 adverse events were similar in both arms, although higher rates of hand-foot syndrome and diarrhea occurred in patients randomly assigned to the doublet arm.

The remaining recommendations from the original 2016 ASCO guideline are unchanged.

The revised guideline is available at this link.

mdales@frontlinemedcom.com

On Twitter @maryjodales

WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.

“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.

Bruce Jancin/Frontline Medical News

The good news

• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.

The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.

• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).

The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.

“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.

• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).

“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.

On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.

• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.

“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”

The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.

“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.

• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.

The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.

The bad news

• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).

• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.

Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.

“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.

• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.

• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).

“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.

• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”

Sleep apnea studies show silver lining

Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).

This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.

As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.

He reported having no financial conflicts.

bjancin@frontlinemedcom.com
 

WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.

“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.

Bruce Jancin/Frontline Medical News

The good news

• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.

The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.

• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).

The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.

“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.

• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).

“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.

On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.

• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.

“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”

The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.

“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.

• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.

The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.

The bad news

• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).

• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.

Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.

“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.

• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.

• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).

“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.

• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”

Sleep apnea studies show silver lining

Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).

This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.

As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.

He reported having no financial conflicts.

bjancin@frontlinemedcom.com
 

WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.

“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.

Bruce Jancin/Frontline Medical News

The good news

• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.

The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.

• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).

The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.

“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.

• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).

“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.

On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.

• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.

“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”

The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.

“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.

• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.

The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.

The bad news

• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).

• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.

Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.

“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.

• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.

• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).

“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.

• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”

Sleep apnea studies show silver lining

Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).

This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.

As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.

He reported having no financial conflicts.

bjancin@frontlinemedcom.com
 

High scores on the symptomless multivariable apnea prediction index (sMVAP) showed a strong correlation with increased risk for postsurgery complications, according to a study approved by the University of Pennsylvania, Philadelphia.

This validation helps assert the benefits of using the sMVAP as a tool to screen for obstructive sleep apnea (OSA) before elective inpatient surgeries, a test that is highly underutilized but very important, wrote M. Melanie Lyons, PhD, of the Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, and her colleagues.

“Most patients having elective surgery are not screened for obstructive sleep apnea, even though OSA is a risk factor for postoperative complications,” wrote Dr. Lyons and her colleagues. “We observe that sMVAP correlates with higher risk for OSA, hypertension, and select postoperative complications, particularly in non-bariatric groups without routine preoperative screening for OSA.”

copyright designer491/Thinkstock

ezimmerman@frontlinemedcom.com

High scores on the symptomless multivariable apnea prediction index (sMVAP) showed a strong correlation with increased risk for postsurgery complications, according to a study approved by the University of Pennsylvania, Philadelphia.

This validation helps assert the benefits of using the sMVAP as a tool to screen for obstructive sleep apnea (OSA) before elective inpatient surgeries, a test that is highly underutilized but very important, wrote M. Melanie Lyons, PhD, of the Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, and her colleagues.

“Most patients having elective surgery are not screened for obstructive sleep apnea, even though OSA is a risk factor for postoperative complications,” wrote Dr. Lyons and her colleagues. “We observe that sMVAP correlates with higher risk for OSA, hypertension, and select postoperative complications, particularly in non-bariatric groups without routine preoperative screening for OSA.”

copyright designer491/Thinkstock

ezimmerman@frontlinemedcom.com

High scores on the symptomless multivariable apnea prediction index (sMVAP) showed a strong correlation with increased risk for postsurgery complications, according to a study approved by the University of Pennsylvania, Philadelphia.

This validation helps assert the benefits of using the sMVAP as a tool to screen for obstructive sleep apnea (OSA) before elective inpatient surgeries, a test that is highly underutilized but very important, wrote M. Melanie Lyons, PhD, of the Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, and her colleagues.

“Most patients having elective surgery are not screened for obstructive sleep apnea, even though OSA is a risk factor for postoperative complications,” wrote Dr. Lyons and her colleagues. “We observe that sMVAP correlates with higher risk for OSA, hypertension, and select postoperative complications, particularly in non-bariatric groups without routine preoperative screening for OSA.”

copyright designer491/Thinkstock

ezimmerman@frontlinemedcom.com

About 3.5 million U.S. adults are chronically infected with hepatitis C (HCV), and 80% of those are baby boomers. As many as 3 out of 4 infected people are not aware of it, according to the CDC, putting them at risk for liver disease, cancer, and death. And most baby boomers aren’t getting tested for the HCV virus.

Between 2013 (when the U.S. Preventive Services Task Force issued a recommendation that all people born between 1945 and 1965 be tested) and 2015, the rate of testing among baby boomers rose only from 12.3% to 13.8%. About 10.5 million of the 76.2 million baby boomers have been tested for HCV, say American Cancer Society researchers who analyzed data from the CDC’s National Health Interview Survey.

Half of Americans identified as ever having had HCV received follow-up testing showing they were still infected, suggesting that even among those who receive an initial antibody test, half may not know for sure whether they still carry the virus.

“Hepatitis C has few noticeable symptoms,” says John Ward, MD, director of the CDC’s Viral Hepatitis Program, and left undiagnosed it threatens the health not only of the person with the virus, but those the disease might be transmitted to. Identifying those who are infected is important, he adds, because new treatments can cure the infection and eliminate the risk of transmission.

About 3.5 million U.S. adults are chronically infected with hepatitis C (HCV), and 80% of those are baby boomers. As many as 3 out of 4 infected people are not aware of it, according to the CDC, putting them at risk for liver disease, cancer, and death. And most baby boomers aren’t getting tested for the HCV virus.

Between 2013 (when the U.S. Preventive Services Task Force issued a recommendation that all people born between 1945 and 1965 be tested) and 2015, the rate of testing among baby boomers rose only from 12.3% to 13.8%. About 10.5 million of the 76.2 million baby boomers have been tested for HCV, say American Cancer Society researchers who analyzed data from the CDC’s National Health Interview Survey.

Half of Americans identified as ever having had HCV received follow-up testing showing they were still infected, suggesting that even among those who receive an initial antibody test, half may not know for sure whether they still carry the virus.

“Hepatitis C has few noticeable symptoms,” says John Ward, MD, director of the CDC’s Viral Hepatitis Program, and left undiagnosed it threatens the health not only of the person with the virus, but those the disease might be transmitted to. Identifying those who are infected is important, he adds, because new treatments can cure the infection and eliminate the risk of transmission.

About 3.5 million U.S. adults are chronically infected with hepatitis C (HCV), and 80% of those are baby boomers. As many as 3 out of 4 infected people are not aware of it, according to the CDC, putting them at risk for liver disease, cancer, and death. And most baby boomers aren’t getting tested for the HCV virus.

Between 2013 (when the U.S. Preventive Services Task Force issued a recommendation that all people born between 1945 and 1965 be tested) and 2015, the rate of testing among baby boomers rose only from 12.3% to 13.8%. About 10.5 million of the 76.2 million baby boomers have been tested for HCV, say American Cancer Society researchers who analyzed data from the CDC’s National Health Interview Survey.

Half of Americans identified as ever having had HCV received follow-up testing showing they were still infected, suggesting that even among those who receive an initial antibody test, half may not know for sure whether they still carry the virus.

“Hepatitis C has few noticeable symptoms,” says John Ward, MD, director of the CDC’s Viral Hepatitis Program, and left undiagnosed it threatens the health not only of the person with the virus, but those the disease might be transmitted to. Identifying those who are infected is important, he adds, because new treatments can cure the infection and eliminate the risk of transmission.

ORLANDO – A combination corticosteroid asthma inhaler has, for the first time, been associated with growth delay and adrenocorticotropic suppression in children.

The single-center case series is small, but the results highlight the need to regularly monitor growth and adrenal function in children using inhaled mometasone furoate/formoterol fumarate (Dulera; Merck), investigators said at the annual meeting of the Endocrine Society.

“We are hoping to raise awareness of this risk in our pediatric endocrinology colleagues, as well as among allergists, pulmonologists, and pediatricians who treat these children,” said Fadi Al Muhaisen, MD. “These kids should be regularly screened for growth delay and adrenal insufficiency and have their growth plotted at every visit as well.”

Michele G. Sullivan/Frontline Medical News

msullivan@frontlinemedcom.com

ORLANDO – A combination corticosteroid asthma inhaler has, for the first time, been associated with growth delay and adrenocorticotropic suppression in children.

The single-center case series is small, but the results highlight the need to regularly monitor growth and adrenal function in children using inhaled mometasone furoate/formoterol fumarate (Dulera; Merck), investigators said at the annual meeting of the Endocrine Society.

“We are hoping to raise awareness of this risk in our pediatric endocrinology colleagues, as well as among allergists, pulmonologists, and pediatricians who treat these children,” said Fadi Al Muhaisen, MD. “These kids should be regularly screened for growth delay and adrenal insufficiency and have their growth plotted at every visit as well.”

Michele G. Sullivan/Frontline Medical News

msullivan@frontlinemedcom.com

ORLANDO – A combination corticosteroid asthma inhaler has, for the first time, been associated with growth delay and adrenocorticotropic suppression in children.

The single-center case series is small, but the results highlight the need to regularly monitor growth and adrenal function in children using inhaled mometasone furoate/formoterol fumarate (Dulera; Merck), investigators said at the annual meeting of the Endocrine Society.

“We are hoping to raise awareness of this risk in our pediatric endocrinology colleagues, as well as among allergists, pulmonologists, and pediatricians who treat these children,” said Fadi Al Muhaisen, MD. “These kids should be regularly screened for growth delay and adrenal insufficiency and have their growth plotted at every visit as well.”

Michele G. Sullivan/Frontline Medical News

msullivan@frontlinemedcom.com

Outpatient visits for influenza were down again in the United States during the week ending April 1, and the number of states at the highest level of flu activity dropped from seven to four, according to the Centers for Disease Control and Prevention.

The national proportion of outpatient visits for influenza-like illness (ILI) was 2.9% for the week ending April 1, compared with 3.2% the week before, the CDC’s Outpatient Influenza-like Illness Surveillance Network reported. The national baseline level is 2.2%.

rfranki@frontlinemedcom.com

Outpatient visits for influenza were down again in the United States during the week ending April 1, and the number of states at the highest level of flu activity dropped from seven to four, according to the Centers for Disease Control and Prevention.

The national proportion of outpatient visits for influenza-like illness (ILI) was 2.9% for the week ending April 1, compared with 3.2% the week before, the CDC’s Outpatient Influenza-like Illness Surveillance Network reported. The national baseline level is 2.2%.

rfranki@frontlinemedcom.com

Outpatient visits for influenza were down again in the United States during the week ending April 1, and the number of states at the highest level of flu activity dropped from seven to four, according to the Centers for Disease Control and Prevention.

The national proportion of outpatient visits for influenza-like illness (ILI) was 2.9% for the week ending April 1, compared with 3.2% the week before, the CDC’s Outpatient Influenza-like Illness Surveillance Network reported. The national baseline level is 2.2%.

rfranki@frontlinemedcom.com