Heidi Splete

At current prices, PCSK9 inhibitors are not cost-effective for patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease, according to an analysis published Aug. 16 in JAMA.

The costs of the cholesterol-lowering drugs would have to be reduced by at least two-thirds to reach cost-effectiveness, on the basis of data from the simulation model of atherosclerotic cardiovascular disease in the United States and the 2015 annual PCSK9 inhibitor costs of $14,350.

The high cost of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibition remains a challenge because it is meant for lifelong use, and “the potential increase in health care expenditures at current or even moderately discounted prices could be staggering,” wrote Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco, and her colleagues (JAMA 2016 Aug 16;316[7]:743-53).

The researchers used the Cardiovascular Disease Policy Model, which included adults aged 35-94 years and compared the cost-effectiveness of PCSK9 inhibitors and ezetimibe in treating two of the three indications for the drugs, heterozygous familial hypercholesterolemia (FH) or atherosclerotic cardiovascular disease (ASCVD). Homozygous FH was not included in the analysis.

The researchers assumed that statins, ezetimibe, and the two approved PCSK9 inhibitors (evolocumab and alirocumab) each would reduce the risk of cardiovascular events by an identical amount per mg/dL of LDL cholesterol reduction.

They found that, for PCSK9 inhibitors to be cost-effective at less than $100,000 per quality-adjusted life-year (QALY), the annual cost would need to drop from its current cost of roughly $14,000 per patient to $4,536 or less per patient, the researchers said.

Overall, the model showed that adding PCSK9 to statins for patients with heterozygous FH or ASCVD prevented 316,300 major adverse cardiovascular events (defined as cardiovascular death, nonfatal MI, or stroke), compared with adding ezetimibe; the cost was $503,000 per QALY. Adding PCSK9 inhibitors to statins for patients with ASCVD prevented about 4.3 million major cardiac adverse events, compared with adding ezetimibe; the cost was $414,000 per QALY.

In addition, the researchers found that PCSK9 inhibitor use would cut cardiovascular care costs by $29 billion over 5 years. However, the model projected an increase of about $592 in annual drug costs from 2015, as well as a 4% annual increase in U.S. health care costs overall.

The results were limited by several factors including the lack of long-term data on outcomes in patients taking PCSK9 inhibitors, the researchers noted. However, the findings suggest that the best way to improve the value of PCSK9 is to cut the price, they added.

In the meantime, “payers must consider the potential trade-off between paying for new drug treatments like PCSK9 inhibitors and investing in interventions known to improve access, physician prescription rates, and patient adherence to statin therapy among those at high ASCVD risk,” they said.

Dr. Bibbins-Domingo is the chair of the U.S. Preventive Services Task Force, but the study does not represent a recommendation from the USPSTF. She had no personal financial conflicts to disclose. The study was funded in part by the New England Comparative Effectiveness Public Advisory Council, which receives grants from several nonprofit organizations.

At current prices, PCSK9 inhibitors are not cost-effective for patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease, according to an analysis published Aug. 16 in JAMA.

The costs of the cholesterol-lowering drugs would have to be reduced by at least two-thirds to reach cost-effectiveness, on the basis of data from the simulation model of atherosclerotic cardiovascular disease in the United States and the 2015 annual PCSK9 inhibitor costs of $14,350.

The high cost of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibition remains a challenge because it is meant for lifelong use, and “the potential increase in health care expenditures at current or even moderately discounted prices could be staggering,” wrote Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco, and her colleagues (JAMA 2016 Aug 16;316[7]:743-53).

The researchers used the Cardiovascular Disease Policy Model, which included adults aged 35-94 years and compared the cost-effectiveness of PCSK9 inhibitors and ezetimibe in treating two of the three indications for the drugs, heterozygous familial hypercholesterolemia (FH) or atherosclerotic cardiovascular disease (ASCVD). Homozygous FH was not included in the analysis.

The researchers assumed that statins, ezetimibe, and the two approved PCSK9 inhibitors (evolocumab and alirocumab) each would reduce the risk of cardiovascular events by an identical amount per mg/dL of LDL cholesterol reduction.

They found that, for PCSK9 inhibitors to be cost-effective at less than $100,000 per quality-adjusted life-year (QALY), the annual cost would need to drop from its current cost of roughly $14,000 per patient to $4,536 or less per patient, the researchers said.

Overall, the model showed that adding PCSK9 to statins for patients with heterozygous FH or ASCVD prevented 316,300 major adverse cardiovascular events (defined as cardiovascular death, nonfatal MI, or stroke), compared with adding ezetimibe; the cost was $503,000 per QALY. Adding PCSK9 inhibitors to statins for patients with ASCVD prevented about 4.3 million major cardiac adverse events, compared with adding ezetimibe; the cost was $414,000 per QALY.

In addition, the researchers found that PCSK9 inhibitor use would cut cardiovascular care costs by $29 billion over 5 years. However, the model projected an increase of about $592 in annual drug costs from 2015, as well as a 4% annual increase in U.S. health care costs overall.

The results were limited by several factors including the lack of long-term data on outcomes in patients taking PCSK9 inhibitors, the researchers noted. However, the findings suggest that the best way to improve the value of PCSK9 is to cut the price, they added.

In the meantime, “payers must consider the potential trade-off between paying for new drug treatments like PCSK9 inhibitors and investing in interventions known to improve access, physician prescription rates, and patient adherence to statin therapy among those at high ASCVD risk,” they said.

Dr. Bibbins-Domingo is the chair of the U.S. Preventive Services Task Force, but the study does not represent a recommendation from the USPSTF. She had no personal financial conflicts to disclose. The study was funded in part by the New England Comparative Effectiveness Public Advisory Council, which receives grants from several nonprofit organizations.

At current prices, PCSK9 inhibitors are not cost-effective for patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease, according to an analysis published Aug. 16 in JAMA.

The costs of the cholesterol-lowering drugs would have to be reduced by at least two-thirds to reach cost-effectiveness, on the basis of data from the simulation model of atherosclerotic cardiovascular disease in the United States and the 2015 annual PCSK9 inhibitor costs of $14,350.

The high cost of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibition remains a challenge because it is meant for lifelong use, and “the potential increase in health care expenditures at current or even moderately discounted prices could be staggering,” wrote Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco, and her colleagues (JAMA 2016 Aug 16;316[7]:743-53).

The researchers used the Cardiovascular Disease Policy Model, which included adults aged 35-94 years and compared the cost-effectiveness of PCSK9 inhibitors and ezetimibe in treating two of the three indications for the drugs, heterozygous familial hypercholesterolemia (FH) or atherosclerotic cardiovascular disease (ASCVD). Homozygous FH was not included in the analysis.

The researchers assumed that statins, ezetimibe, and the two approved PCSK9 inhibitors (evolocumab and alirocumab) each would reduce the risk of cardiovascular events by an identical amount per mg/dL of LDL cholesterol reduction.

They found that, for PCSK9 inhibitors to be cost-effective at less than $100,000 per quality-adjusted life-year (QALY), the annual cost would need to drop from its current cost of roughly $14,000 per patient to $4,536 or less per patient, the researchers said.

Overall, the model showed that adding PCSK9 to statins for patients with heterozygous FH or ASCVD prevented 316,300 major adverse cardiovascular events (defined as cardiovascular death, nonfatal MI, or stroke), compared with adding ezetimibe; the cost was $503,000 per QALY. Adding PCSK9 inhibitors to statins for patients with ASCVD prevented about 4.3 million major cardiac adverse events, compared with adding ezetimibe; the cost was $414,000 per QALY.

In addition, the researchers found that PCSK9 inhibitor use would cut cardiovascular care costs by $29 billion over 5 years. However, the model projected an increase of about $592 in annual drug costs from 2015, as well as a 4% annual increase in U.S. health care costs overall.

The results were limited by several factors including the lack of long-term data on outcomes in patients taking PCSK9 inhibitors, the researchers noted. However, the findings suggest that the best way to improve the value of PCSK9 is to cut the price, they added.

In the meantime, “payers must consider the potential trade-off between paying for new drug treatments like PCSK9 inhibitors and investing in interventions known to improve access, physician prescription rates, and patient adherence to statin therapy among those at high ASCVD risk,” they said.

Dr. Bibbins-Domingo is the chair of the U.S. Preventive Services Task Force, but the study does not represent a recommendation from the USPSTF. She had no personal financial conflicts to disclose. The study was funded in part by the New England Comparative Effectiveness Public Advisory Council, which receives grants from several nonprofit organizations.

Topical timolol maleate acts as an effective alternate to oral propranolol for treatment of certain infantile hemangiomas (IHs), based on data from a retrospective study of 731 children. The findings were published online August 15 in Pediatrics.

“Superficial, relatively thin IHs, regardless of pretreatment surface or body site, are likely to respond reasonably well to several months of treatment with modest, but definite improvements in color and size,” wrote Katherine Püttgen, MD, of Johns Hopkins University in Baltimore, Md., and colleagues in the Hemangioma Investigator Group (Pediatrics 2016;138:e20160355 [doi: 10.1052/peds.2016-0355]).

Courtesy CDC/Richard S. Hibbets

Although topical timolol maleate (TTM) has been used off label to treat infantile hemangiomas since 2010, “there is very limited information regarding off-label safety and pharmacokinetic data when used on hemangioma-affected skin,” the researchers noted.

The researchers reviewed data from 731 children treated at nine pediatric centers in the United States. Patients were treated for at least 30 days; the average treatment duration was 9 months. Most of the children (41%) began treatment between ages 0 and 3 months, and 86% were treatment naïve.

About 85% of the children received TTM 0.5% GFS (gel-forming solution), with parents instructed to apply 1 drop twice daily to the IH; 15% were prescribed 4 drops or more of TTM daily. Treatment response was assessed based on visual analog scales for color (VAS-C) and for size, extent, and volume (VAS-SEV).

Overall, 70% of children showed improvement of at least 10% from baseline on the VAS-C after 1-3 months of treatment, and 92% showed meaningful improvement from baseline after 6-9 months of treatment. VAS-SEV scores improved at least 10% from baseline in 39% of children after 1-3 months and meaningful improvement in 76% after 6-9 months.

Independent predictors of treatment success included longer treatment time and thinner, superficial IH at baseline.

Adverse events were observed in 3% of the patients, approximately half of which were reports of scaly skin. No patients discontinued the study because of adverse events, and no cardiovascular adverse events were reported.

The results were limited by several factors including the lack of controls and the retrospective nature of the study, the researchers noted. In addition, they cautioned against the use of However, the findings suggest that “TTM can be recommended as an initial, and often sole, treatment modality for many relatively superficial His without aggressive growth or threat of functional impairment,” they said. However, the researchers cautioned against TTM in cases of ulcerated IHs because of the potential for increased drug absorption.

Dr. Püttgen and several coauthors disclosed serving as consultants to Pierre Fabre.

Topical timolol maleate acts as an effective alternate to oral propranolol for treatment of certain infantile hemangiomas (IHs), based on data from a retrospective study of 731 children. The findings were published online August 15 in Pediatrics.

“Superficial, relatively thin IHs, regardless of pretreatment surface or body site, are likely to respond reasonably well to several months of treatment with modest, but definite improvements in color and size,” wrote Katherine Püttgen, MD, of Johns Hopkins University in Baltimore, Md., and colleagues in the Hemangioma Investigator Group (Pediatrics 2016;138:e20160355 [doi: 10.1052/peds.2016-0355]).

Courtesy CDC/Richard S. Hibbets

Although topical timolol maleate (TTM) has been used off label to treat infantile hemangiomas since 2010, “there is very limited information regarding off-label safety and pharmacokinetic data when used on hemangioma-affected skin,” the researchers noted.

The researchers reviewed data from 731 children treated at nine pediatric centers in the United States. Patients were treated for at least 30 days; the average treatment duration was 9 months. Most of the children (41%) began treatment between ages 0 and 3 months, and 86% were treatment naïve.

About 85% of the children received TTM 0.5% GFS (gel-forming solution), with parents instructed to apply 1 drop twice daily to the IH; 15% were prescribed 4 drops or more of TTM daily. Treatment response was assessed based on visual analog scales for color (VAS-C) and for size, extent, and volume (VAS-SEV).

Overall, 70% of children showed improvement of at least 10% from baseline on the VAS-C after 1-3 months of treatment, and 92% showed meaningful improvement from baseline after 6-9 months of treatment. VAS-SEV scores improved at least 10% from baseline in 39% of children after 1-3 months and meaningful improvement in 76% after 6-9 months.

Independent predictors of treatment success included longer treatment time and thinner, superficial IH at baseline.

Adverse events were observed in 3% of the patients, approximately half of which were reports of scaly skin. No patients discontinued the study because of adverse events, and no cardiovascular adverse events were reported.

The results were limited by several factors including the lack of controls and the retrospective nature of the study, the researchers noted. In addition, they cautioned against the use of However, the findings suggest that “TTM can be recommended as an initial, and often sole, treatment modality for many relatively superficial His without aggressive growth or threat of functional impairment,” they said. However, the researchers cautioned against TTM in cases of ulcerated IHs because of the potential for increased drug absorption.

Dr. Püttgen and several coauthors disclosed serving as consultants to Pierre Fabre.

Topical timolol maleate acts as an effective alternate to oral propranolol for treatment of certain infantile hemangiomas (IHs), based on data from a retrospective study of 731 children. The findings were published online August 15 in Pediatrics.

“Superficial, relatively thin IHs, regardless of pretreatment surface or body site, are likely to respond reasonably well to several months of treatment with modest, but definite improvements in color and size,” wrote Katherine Püttgen, MD, of Johns Hopkins University in Baltimore, Md., and colleagues in the Hemangioma Investigator Group (Pediatrics 2016;138:e20160355 [doi: 10.1052/peds.2016-0355]).

Courtesy CDC/Richard S. Hibbets

Although topical timolol maleate (TTM) has been used off label to treat infantile hemangiomas since 2010, “there is very limited information regarding off-label safety and pharmacokinetic data when used on hemangioma-affected skin,” the researchers noted.

The researchers reviewed data from 731 children treated at nine pediatric centers in the United States. Patients were treated for at least 30 days; the average treatment duration was 9 months. Most of the children (41%) began treatment between ages 0 and 3 months, and 86% were treatment naïve.

About 85% of the children received TTM 0.5% GFS (gel-forming solution), with parents instructed to apply 1 drop twice daily to the IH; 15% were prescribed 4 drops or more of TTM daily. Treatment response was assessed based on visual analog scales for color (VAS-C) and for size, extent, and volume (VAS-SEV).

Overall, 70% of children showed improvement of at least 10% from baseline on the VAS-C after 1-3 months of treatment, and 92% showed meaningful improvement from baseline after 6-9 months of treatment. VAS-SEV scores improved at least 10% from baseline in 39% of children after 1-3 months and meaningful improvement in 76% after 6-9 months.

Independent predictors of treatment success included longer treatment time and thinner, superficial IH at baseline.

Adverse events were observed in 3% of the patients, approximately half of which were reports of scaly skin. No patients discontinued the study because of adverse events, and no cardiovascular adverse events were reported.

The results were limited by several factors including the lack of controls and the retrospective nature of the study, the researchers noted. In addition, they cautioned against the use of However, the findings suggest that “TTM can be recommended as an initial, and often sole, treatment modality for many relatively superficial His without aggressive growth or threat of functional impairment,” they said. However, the researchers cautioned against TTM in cases of ulcerated IHs because of the potential for increased drug absorption.

Dr. Püttgen and several coauthors disclosed serving as consultants to Pierre Fabre.

Clinicians should treat patients diagnosed with HIV and tuberculosis for both conditions immediately, according to new guidelines on the treatment of drug-susceptible tuberculosis.

The clinical practice guidelines were issued collectively by three organizations: the American Thoracic Society (ATS), the U.S. Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA), and published online in Clinical Infectious Diseases.

CDC/James Archer

The guidelines recommend starting TB treatment for all patients as soon as an infection is suspected, rather than waiting for test results, and focusing on daily therapy to reduce the risk of relapse. In addition, all TB patients should receive comprehensive care, including direct observed therapy (DOT) when appropriate (Clin Infect Dis. 2016 Aug 10. doi: 10.1093/cid/ciw376).

“Treatment of tuberculosis is focused on both curing the individual patient and minimizing the transmission,” wrote Payam Nahid, MD, professor of medicine at the University of California, San Francisco, and his colleagues on the guidelines committee.

The guidelines’ section on treatment of tuberculosis in special situations addresses management of TB in patients with conditions including HIV, extrapulmonary TB, culture-negative pulmonary TB, pregnancy, renal disease, and hepatic disease, as well as treatment of children and the elderly.

With regard to HIV, the guidelines recommend the standard 6-month daily TB treatment for HIV patients on antiretroviral therapy. This treatment includes 2 months of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB), followed by a continuation phase of 4 months of INH and RIF.

“Patients with HIV infection and tuberculosis are at an increased risk of developing paradoxical worsening of symptoms, signs, or clinical manifestations of tuberculosis after beginning antituberculosis and antiretroviral treatments,” according to the guidelines. These responses are defined as Immune Reconstitution Inflammatory Syndrome (IRIS). However, IRIS does not appear to impact the simultaneous treatment of TB and HIV, and the condition can be managed symptomatically if it occurs, the researchers noted.

The guidelines identified several areas in need of further study, including new TB drugs and treatment plans; the effects of biomarkers to help design individual therapy; TB in special populations including HIV patients, pregnant women, and children; and treatment delivery strategies.

The guidelines also are endorsed by the European Respiratory Society (ERS) and the U.S. National Tuberculosis Controllers Association (NCTA).

The American Thoracic Society, the Infections Diseases Society of America, and the Centers for Disease Control and Prevention provided financial support. Lead author Dr. Nahid had no financial conflicts to disclose.

Clinicians should treat patients diagnosed with HIV and tuberculosis for both conditions immediately, according to new guidelines on the treatment of drug-susceptible tuberculosis.

The clinical practice guidelines were issued collectively by three organizations: the American Thoracic Society (ATS), the U.S. Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA), and published online in Clinical Infectious Diseases.

CDC/James Archer

The guidelines recommend starting TB treatment for all patients as soon as an infection is suspected, rather than waiting for test results, and focusing on daily therapy to reduce the risk of relapse. In addition, all TB patients should receive comprehensive care, including direct observed therapy (DOT) when appropriate (Clin Infect Dis. 2016 Aug 10. doi: 10.1093/cid/ciw376).

“Treatment of tuberculosis is focused on both curing the individual patient and minimizing the transmission,” wrote Payam Nahid, MD, professor of medicine at the University of California, San Francisco, and his colleagues on the guidelines committee.

The guidelines’ section on treatment of tuberculosis in special situations addresses management of TB in patients with conditions including HIV, extrapulmonary TB, culture-negative pulmonary TB, pregnancy, renal disease, and hepatic disease, as well as treatment of children and the elderly.

With regard to HIV, the guidelines recommend the standard 6-month daily TB treatment for HIV patients on antiretroviral therapy. This treatment includes 2 months of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB), followed by a continuation phase of 4 months of INH and RIF.

“Patients with HIV infection and tuberculosis are at an increased risk of developing paradoxical worsening of symptoms, signs, or clinical manifestations of tuberculosis after beginning antituberculosis and antiretroviral treatments,” according to the guidelines. These responses are defined as Immune Reconstitution Inflammatory Syndrome (IRIS). However, IRIS does not appear to impact the simultaneous treatment of TB and HIV, and the condition can be managed symptomatically if it occurs, the researchers noted.

The guidelines identified several areas in need of further study, including new TB drugs and treatment plans; the effects of biomarkers to help design individual therapy; TB in special populations including HIV patients, pregnant women, and children; and treatment delivery strategies.

The guidelines also are endorsed by the European Respiratory Society (ERS) and the U.S. National Tuberculosis Controllers Association (NCTA).

The American Thoracic Society, the Infections Diseases Society of America, and the Centers for Disease Control and Prevention provided financial support. Lead author Dr. Nahid had no financial conflicts to disclose.

Clinicians should treat patients diagnosed with HIV and tuberculosis for both conditions immediately, according to new guidelines on the treatment of drug-susceptible tuberculosis.

The clinical practice guidelines were issued collectively by three organizations: the American Thoracic Society (ATS), the U.S. Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA), and published online in Clinical Infectious Diseases.

CDC/James Archer

The guidelines recommend starting TB treatment for all patients as soon as an infection is suspected, rather than waiting for test results, and focusing on daily therapy to reduce the risk of relapse. In addition, all TB patients should receive comprehensive care, including direct observed therapy (DOT) when appropriate (Clin Infect Dis. 2016 Aug 10. doi: 10.1093/cid/ciw376).

“Treatment of tuberculosis is focused on both curing the individual patient and minimizing the transmission,” wrote Payam Nahid, MD, professor of medicine at the University of California, San Francisco, and his colleagues on the guidelines committee.

The guidelines’ section on treatment of tuberculosis in special situations addresses management of TB in patients with conditions including HIV, extrapulmonary TB, culture-negative pulmonary TB, pregnancy, renal disease, and hepatic disease, as well as treatment of children and the elderly.

With regard to HIV, the guidelines recommend the standard 6-month daily TB treatment for HIV patients on antiretroviral therapy. This treatment includes 2 months of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB), followed by a continuation phase of 4 months of INH and RIF.

“Patients with HIV infection and tuberculosis are at an increased risk of developing paradoxical worsening of symptoms, signs, or clinical manifestations of tuberculosis after beginning antituberculosis and antiretroviral treatments,” according to the guidelines. These responses are defined as Immune Reconstitution Inflammatory Syndrome (IRIS). However, IRIS does not appear to impact the simultaneous treatment of TB and HIV, and the condition can be managed symptomatically if it occurs, the researchers noted.

The guidelines identified several areas in need of further study, including new TB drugs and treatment plans; the effects of biomarkers to help design individual therapy; TB in special populations including HIV patients, pregnant women, and children; and treatment delivery strategies.

The guidelines also are endorsed by the European Respiratory Society (ERS) and the U.S. National Tuberculosis Controllers Association (NCTA).

The American Thoracic Society, the Infections Diseases Society of America, and the Centers for Disease Control and Prevention provided financial support. Lead author Dr. Nahid had no financial conflicts to disclose.

A daily dose of omega-3 fatty acids from fish oil significantly improved heart function in adults after heart attacks, based on data from a randomized trial of 358 heart attack survivors. The findings were published online Aug. 1 in Circulation.

Patients who received 4 grams of omega-3 fatty acids from fish oil (O-3FA) for 6 months had significant reductions in left ventricular end-systolic volume index (–5.8%) and noninfarct myocardial fibrosis (–5.6%), compared with placebo patients, Bobak Heydari, MD, MPH, of Brigham and Women’s Hospital, Boston, and colleagues.

The effects remained significant after adjusting for factors including guideline-based standard post-heart attack medical therapies, they noted.

Treatment with omega-3 fatty acids (O-3FA) “also was associated with a significant reduction of both biomarkers of inflammation (myeloperoxidase, lipoprotein-associated phospholipase A2) and myocardial fibrosis (ST2),” the researchers wrote. “We therefore speculate that O-3FA treatment provides the aforementioned improvement in LV remodeling and noninfarct myocardial fibrosis through suppression of inflammation at both systemic and myocardial levels during the convalescent healing phase after acute MI,” they noted.

The results build on data from a previous study showing an association between daily doses of O-3FA and improved survival rates in heart attack patients, but the specific impact on heart structure and tissue has not been well studied, the researchers noted (Circulation. 2016;134:378-91 doi: 10.1161/circulationaha.115.019949).

The OMEGA-REMODEL trial (Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction) was designed to assess the impact of omega-3 fatty acids on heart healing after a heart attack. The average age of the patients was about 60 years. Demographic characteristics and cardiovascular disease histories were not significantly different between the groups.

Compliance for both treatment and placebo groups was 96% based on pill counts. Nausea was the most common side effect, reported by 5.9% of treatment patients and 5.4% of placebo patients. No serious adverse events associated with treatment were reported.

The findings were limited by several factors, including the possible use of over-the-counter fish oil supplementation by patients, the researchers noted. “However, dose-response relationship between O-3FA therapy and our main study endpoints strongly supported our intention-to-treat analysis,” they said.

The study was funded by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose.

A daily dose of omega-3 fatty acids from fish oil significantly improved heart function in adults after heart attacks, based on data from a randomized trial of 358 heart attack survivors. The findings were published online Aug. 1 in Circulation.

Patients who received 4 grams of omega-3 fatty acids from fish oil (O-3FA) for 6 months had significant reductions in left ventricular end-systolic volume index (–5.8%) and noninfarct myocardial fibrosis (–5.6%), compared with placebo patients, Bobak Heydari, MD, MPH, of Brigham and Women’s Hospital, Boston, and colleagues.

The effects remained significant after adjusting for factors including guideline-based standard post-heart attack medical therapies, they noted.

Treatment with omega-3 fatty acids (O-3FA) “also was associated with a significant reduction of both biomarkers of inflammation (myeloperoxidase, lipoprotein-associated phospholipase A2) and myocardial fibrosis (ST2),” the researchers wrote. “We therefore speculate that O-3FA treatment provides the aforementioned improvement in LV remodeling and noninfarct myocardial fibrosis through suppression of inflammation at both systemic and myocardial levels during the convalescent healing phase after acute MI,” they noted.

The results build on data from a previous study showing an association between daily doses of O-3FA and improved survival rates in heart attack patients, but the specific impact on heart structure and tissue has not been well studied, the researchers noted (Circulation. 2016;134:378-91 doi: 10.1161/circulationaha.115.019949).

The OMEGA-REMODEL trial (Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction) was designed to assess the impact of omega-3 fatty acids on heart healing after a heart attack. The average age of the patients was about 60 years. Demographic characteristics and cardiovascular disease histories were not significantly different between the groups.

Compliance for both treatment and placebo groups was 96% based on pill counts. Nausea was the most common side effect, reported by 5.9% of treatment patients and 5.4% of placebo patients. No serious adverse events associated with treatment were reported.

The findings were limited by several factors, including the possible use of over-the-counter fish oil supplementation by patients, the researchers noted. “However, dose-response relationship between O-3FA therapy and our main study endpoints strongly supported our intention-to-treat analysis,” they said.

The study was funded by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose.

A daily dose of omega-3 fatty acids from fish oil significantly improved heart function in adults after heart attacks, based on data from a randomized trial of 358 heart attack survivors. The findings were published online Aug. 1 in Circulation.

Patients who received 4 grams of omega-3 fatty acids from fish oil (O-3FA) for 6 months had significant reductions in left ventricular end-systolic volume index (–5.8%) and noninfarct myocardial fibrosis (–5.6%), compared with placebo patients, Bobak Heydari, MD, MPH, of Brigham and Women’s Hospital, Boston, and colleagues.

The effects remained significant after adjusting for factors including guideline-based standard post-heart attack medical therapies, they noted.

Treatment with omega-3 fatty acids (O-3FA) “also was associated with a significant reduction of both biomarkers of inflammation (myeloperoxidase, lipoprotein-associated phospholipase A2) and myocardial fibrosis (ST2),” the researchers wrote. “We therefore speculate that O-3FA treatment provides the aforementioned improvement in LV remodeling and noninfarct myocardial fibrosis through suppression of inflammation at both systemic and myocardial levels during the convalescent healing phase after acute MI,” they noted.

The results build on data from a previous study showing an association between daily doses of O-3FA and improved survival rates in heart attack patients, but the specific impact on heart structure and tissue has not been well studied, the researchers noted (Circulation. 2016;134:378-91 doi: 10.1161/circulationaha.115.019949).

The OMEGA-REMODEL trial (Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction) was designed to assess the impact of omega-3 fatty acids on heart healing after a heart attack. The average age of the patients was about 60 years. Demographic characteristics and cardiovascular disease histories were not significantly different between the groups.

Compliance for both treatment and placebo groups was 96% based on pill counts. Nausea was the most common side effect, reported by 5.9% of treatment patients and 5.4% of placebo patients. No serious adverse events associated with treatment were reported.

The findings were limited by several factors, including the possible use of over-the-counter fish oil supplementation by patients, the researchers noted. “However, dose-response relationship between O-3FA therapy and our main study endpoints strongly supported our intention-to-treat analysis,” they said.

The study was funded by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose.

The benefits and harms of visual screen cancer screening exams for asymptomatic adults can’t be adequately assessed with current evidence, according to a new recommendation from the U.S. Preventive Services Task Force.

“Evidence is inadequate to reliably conclude that early detection of skin cancer through visual skin examination by a clinician reduces morbidity or mortality,” according to the statement published online July 26 in JAMA (2016;316[4]:429-435. doi:10.1001/jama.2016.8465).

©Wavebreakmedia Ltd/Thinkstock

Approximately 76,400 adults in the United States will develop melanoma, and more than 10,000 will die from it, according to the USPSTF. However, more than 98% of skin cancer cases in the United States are basal and squamous cell carcinoma, which have much lower morbidity and mortality rates, noted the USPSTF researchers, led by Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco.

The current statement updates the USPSTF’s 2009 recommendation, which also found insufficient evidence to assess the harms and benefits of visual skin cancer screening in asymptomatic adults with no history of premalignant or malignant skin lesions. However, the current recommendation eliminates a statement about patients’ skin self-exams.

According to the USPSTF, evidence is “adequate” that a clinician’s visual skin exam has “modest sensitivity and specificity for detecting melanoma,” but evidence is inconsistent to support the ability of a visual skin exam to detect nonmelanoma skin cancer.

The USPSTF commissioned an evidence review that included 11 studies previously reviewed and 2 additional studies conducted since 2009. The two new studies included one that evaluated skin cancer screening performed by dermatologists or plastic surgeons and one that evaluated skin cancer screening performed by primary care physicians. Sensitivity and specificity in the two studies ranged from 40% to 70% and from 86% to 98%, respectively.

“None of the studies could draw reliable conclusions as to whether screening performed by any of the clinical specialties differed in diagnostic accuracy,” the researchers noted. In addition, “no [randomized controlled trial] has directly evaluated the effectiveness of the clinical visual skin examination for reducing skin cancer morbidity and mortality,” they wrote.

The recommendation was accompanied by several editorials published online July 26 in JAMA journals.

In JAMA, Hensin Tsao, MD, PhD, of Massachusetts General Hospital, Boston, and Martin Weinstock, MD, PhD, of Brown University, Providence, R.I., noted that the USPSTF considered the possibility of including information from high-quality case-control studies in lieu of randomized controlled trials, which have been difficult to conduct in skin cancer screening. “The evidentiary standard needs to be further refined to be appropriate to the modest magnitude of potential harms of a properly performed skin cancer screening,” they wrote (JAMA. 2016;316:398-400). Dr. Tsao disclosed an honorarium from Lubax.

In JAMA Dermatology, Susan Swetter, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System; Alan C. Geller, MPH, of Harvard School of Public Health, Boston; and Allan C. Halpern, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote about ways to promote broader uptake of skin cancer screening. “Alternative models should be explored to bundle skin screening with other preventive services (e.g., blood pressure measurements or flu shots) and to engage advanced practice providers (e.g., nurse practitioners and physician assistants) to promote screening among individuals with less access to dermatologists,” they wrote (JAMA Dermatol. 2016. doi: 10.1001/jamadermatol.2016.2606).

In JAMA Oncology, Vinayak K. Nahar, MD, of the University of Mississippi Medical Center, Jackson; Jonathan E. Mayer, MD, of Johns Hopkins University, Baltimore; and Jane M. Grant-Kels, MD, of the University of Connecticut, Farmington, addressed concerns over performing more biopsies. “The USPSTF also raises concern over the number needed to biopsy to detect 1 case of melanoma. In weighing these data, one must also consider that many of the nonmelanomas biopsied were likely severely atypical nevi that have their own risk of malignant transformation. Although difficult to quantify, there is some benefit to removing a severely atypical nevus, both for risk of transformation and for a patient’s peace of mind,” they wrote (JAMA Oncol. 2016. doi: 10.1001/jamaoncol.2016.2440).

In JAMA Internal Medicine, Eleni Linos, MD, of the University of California, San Francisco; Kenneth A. Katz, MD, of Kaiser Permanente, San Francisco; and Graham A. Colditz, MD, of Washington University, St. Louis, cautioned that the USPSTF recommendations shouldn’t be interpreted as minimizing the importance of skin cancer. “Instead, the report should motivate us to improve the evidence base for identifying groups of people in whom the benefits of screening might outweigh risks,” they wrote. “Meanwhile, we should also fully implement skin cancer primary prevention by eliminating indoor tanning exposure, especially among youths, and increasing the use of sun-protection strategies that work” (JAMA Intern. Med. 2016. doi: 10.1001/jamaintermed.2016.5008).

The recommendations are not an official position of the U.S. Department of Health and Human Services or the Agency for Healthcare Research and Quality.

The benefits and harms of visual screen cancer screening exams for asymptomatic adults can’t be adequately assessed with current evidence, according to a new recommendation from the U.S. Preventive Services Task Force.

“Evidence is inadequate to reliably conclude that early detection of skin cancer through visual skin examination by a clinician reduces morbidity or mortality,” according to the statement published online July 26 in JAMA (2016;316[4]:429-435. doi:10.1001/jama.2016.8465).

©Wavebreakmedia Ltd/Thinkstock

Approximately 76,400 adults in the United States will develop melanoma, and more than 10,000 will die from it, according to the USPSTF. However, more than 98% of skin cancer cases in the United States are basal and squamous cell carcinoma, which have much lower morbidity and mortality rates, noted the USPSTF researchers, led by Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco.

The current statement updates the USPSTF’s 2009 recommendation, which also found insufficient evidence to assess the harms and benefits of visual skin cancer screening in asymptomatic adults with no history of premalignant or malignant skin lesions. However, the current recommendation eliminates a statement about patients’ skin self-exams.

According to the USPSTF, evidence is “adequate” that a clinician’s visual skin exam has “modest sensitivity and specificity for detecting melanoma,” but evidence is inconsistent to support the ability of a visual skin exam to detect nonmelanoma skin cancer.

The USPSTF commissioned an evidence review that included 11 studies previously reviewed and 2 additional studies conducted since 2009. The two new studies included one that evaluated skin cancer screening performed by dermatologists or plastic surgeons and one that evaluated skin cancer screening performed by primary care physicians. Sensitivity and specificity in the two studies ranged from 40% to 70% and from 86% to 98%, respectively.

“None of the studies could draw reliable conclusions as to whether screening performed by any of the clinical specialties differed in diagnostic accuracy,” the researchers noted. In addition, “no [randomized controlled trial] has directly evaluated the effectiveness of the clinical visual skin examination for reducing skin cancer morbidity and mortality,” they wrote.

The recommendation was accompanied by several editorials published online July 26 in JAMA journals.

In JAMA, Hensin Tsao, MD, PhD, of Massachusetts General Hospital, Boston, and Martin Weinstock, MD, PhD, of Brown University, Providence, R.I., noted that the USPSTF considered the possibility of including information from high-quality case-control studies in lieu of randomized controlled trials, which have been difficult to conduct in skin cancer screening. “The evidentiary standard needs to be further refined to be appropriate to the modest magnitude of potential harms of a properly performed skin cancer screening,” they wrote (JAMA. 2016;316:398-400). Dr. Tsao disclosed an honorarium from Lubax.

In JAMA Dermatology, Susan Swetter, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System; Alan C. Geller, MPH, of Harvard School of Public Health, Boston; and Allan C. Halpern, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote about ways to promote broader uptake of skin cancer screening. “Alternative models should be explored to bundle skin screening with other preventive services (e.g., blood pressure measurements or flu shots) and to engage advanced practice providers (e.g., nurse practitioners and physician assistants) to promote screening among individuals with less access to dermatologists,” they wrote (JAMA Dermatol. 2016. doi: 10.1001/jamadermatol.2016.2606).

In JAMA Oncology, Vinayak K. Nahar, MD, of the University of Mississippi Medical Center, Jackson; Jonathan E. Mayer, MD, of Johns Hopkins University, Baltimore; and Jane M. Grant-Kels, MD, of the University of Connecticut, Farmington, addressed concerns over performing more biopsies. “The USPSTF also raises concern over the number needed to biopsy to detect 1 case of melanoma. In weighing these data, one must also consider that many of the nonmelanomas biopsied were likely severely atypical nevi that have their own risk of malignant transformation. Although difficult to quantify, there is some benefit to removing a severely atypical nevus, both for risk of transformation and for a patient’s peace of mind,” they wrote (JAMA Oncol. 2016. doi: 10.1001/jamaoncol.2016.2440).

In JAMA Internal Medicine, Eleni Linos, MD, of the University of California, San Francisco; Kenneth A. Katz, MD, of Kaiser Permanente, San Francisco; and Graham A. Colditz, MD, of Washington University, St. Louis, cautioned that the USPSTF recommendations shouldn’t be interpreted as minimizing the importance of skin cancer. “Instead, the report should motivate us to improve the evidence base for identifying groups of people in whom the benefits of screening might outweigh risks,” they wrote. “Meanwhile, we should also fully implement skin cancer primary prevention by eliminating indoor tanning exposure, especially among youths, and increasing the use of sun-protection strategies that work” (JAMA Intern. Med. 2016. doi: 10.1001/jamaintermed.2016.5008).

The recommendations are not an official position of the U.S. Department of Health and Human Services or the Agency for Healthcare Research and Quality.

The benefits and harms of visual screen cancer screening exams for asymptomatic adults can’t be adequately assessed with current evidence, according to a new recommendation from the U.S. Preventive Services Task Force.

“Evidence is inadequate to reliably conclude that early detection of skin cancer through visual skin examination by a clinician reduces morbidity or mortality,” according to the statement published online July 26 in JAMA (2016;316[4]:429-435. doi:10.1001/jama.2016.8465).

©Wavebreakmedia Ltd/Thinkstock

Approximately 76,400 adults in the United States will develop melanoma, and more than 10,000 will die from it, according to the USPSTF. However, more than 98% of skin cancer cases in the United States are basal and squamous cell carcinoma, which have much lower morbidity and mortality rates, noted the USPSTF researchers, led by Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco.

The current statement updates the USPSTF’s 2009 recommendation, which also found insufficient evidence to assess the harms and benefits of visual skin cancer screening in asymptomatic adults with no history of premalignant or malignant skin lesions. However, the current recommendation eliminates a statement about patients’ skin self-exams.

According to the USPSTF, evidence is “adequate” that a clinician’s visual skin exam has “modest sensitivity and specificity for detecting melanoma,” but evidence is inconsistent to support the ability of a visual skin exam to detect nonmelanoma skin cancer.

The USPSTF commissioned an evidence review that included 11 studies previously reviewed and 2 additional studies conducted since 2009. The two new studies included one that evaluated skin cancer screening performed by dermatologists or plastic surgeons and one that evaluated skin cancer screening performed by primary care physicians. Sensitivity and specificity in the two studies ranged from 40% to 70% and from 86% to 98%, respectively.

“None of the studies could draw reliable conclusions as to whether screening performed by any of the clinical specialties differed in diagnostic accuracy,” the researchers noted. In addition, “no [randomized controlled trial] has directly evaluated the effectiveness of the clinical visual skin examination for reducing skin cancer morbidity and mortality,” they wrote.

The recommendation was accompanied by several editorials published online July 26 in JAMA journals.

In JAMA, Hensin Tsao, MD, PhD, of Massachusetts General Hospital, Boston, and Martin Weinstock, MD, PhD, of Brown University, Providence, R.I., noted that the USPSTF considered the possibility of including information from high-quality case-control studies in lieu of randomized controlled trials, which have been difficult to conduct in skin cancer screening. “The evidentiary standard needs to be further refined to be appropriate to the modest magnitude of potential harms of a properly performed skin cancer screening,” they wrote (JAMA. 2016;316:398-400). Dr. Tsao disclosed an honorarium from Lubax.

In JAMA Dermatology, Susan Swetter, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System; Alan C. Geller, MPH, of Harvard School of Public Health, Boston; and Allan C. Halpern, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote about ways to promote broader uptake of skin cancer screening. “Alternative models should be explored to bundle skin screening with other preventive services (e.g., blood pressure measurements or flu shots) and to engage advanced practice providers (e.g., nurse practitioners and physician assistants) to promote screening among individuals with less access to dermatologists,” they wrote (JAMA Dermatol. 2016. doi: 10.1001/jamadermatol.2016.2606).

In JAMA Oncology, Vinayak K. Nahar, MD, of the University of Mississippi Medical Center, Jackson; Jonathan E. Mayer, MD, of Johns Hopkins University, Baltimore; and Jane M. Grant-Kels, MD, of the University of Connecticut, Farmington, addressed concerns over performing more biopsies. “The USPSTF also raises concern over the number needed to biopsy to detect 1 case of melanoma. In weighing these data, one must also consider that many of the nonmelanomas biopsied were likely severely atypical nevi that have their own risk of malignant transformation. Although difficult to quantify, there is some benefit to removing a severely atypical nevus, both for risk of transformation and for a patient’s peace of mind,” they wrote (JAMA Oncol. 2016. doi: 10.1001/jamaoncol.2016.2440).

In JAMA Internal Medicine, Eleni Linos, MD, of the University of California, San Francisco; Kenneth A. Katz, MD, of Kaiser Permanente, San Francisco; and Graham A. Colditz, MD, of Washington University, St. Louis, cautioned that the USPSTF recommendations shouldn’t be interpreted as minimizing the importance of skin cancer. “Instead, the report should motivate us to improve the evidence base for identifying groups of people in whom the benefits of screening might outweigh risks,” they wrote. “Meanwhile, we should also fully implement skin cancer primary prevention by eliminating indoor tanning exposure, especially among youths, and increasing the use of sun-protection strategies that work” (JAMA Intern. Med. 2016. doi: 10.1001/jamaintermed.2016.5008).

The recommendations are not an official position of the U.S. Department of Health and Human Services or the Agency for Healthcare Research and Quality.

Use of long-acting reversible contraception immediately post partum can help reduce the risk of unintended and short-interval pregnancy, according to a new policy statement from the American College of Obstetricians and Gynecologists.

“Immediate postpartum LARC should be offered as an effective option for postpartum contraception; there are few contraindications to postpartum IUDs and implants,” according to the statement issued by ACOG’s Committee on Obstetric Practice (Obstet Gynecol. 2016;128:e32-37).

flocu/ThinkStock.com

Unintended pregnancies account for approximately 45% of pregnancies in the United States overall, and at least 70% of pregnancies in the first year post partum, the committee noted.

The statement recommends prenatal counseling about the risks and benefits of LARCs, along with alternatives, to help patients make informed decisions. The committee emphasized that health care providers “should counsel women about the convenience and effectiveness of immediate postpartum LARC, as well as the benefits of reducing unintended pregnancy and lengthening pregnancy intervals.”

However, immediate postpartum use of IUDs is contraindicated in women with intrauterine infection at delivery, postpartum hemorrhage, and puerperal sepsis.

The committee called for systems to provide LARC at the comprehensive postpartum visit if necessary, and recommended stocking LARC devices in labor and delivery units for immediate postpartum placement. In addition, coding and reimbursement strategies are needed to support immediate postpartum LARC, according to the statement.

The policy statement was endorsed by the American College of Nurse-Midwives and the Society for Maternal-Fetal Medicine.

Use of long-acting reversible contraception immediately post partum can help reduce the risk of unintended and short-interval pregnancy, according to a new policy statement from the American College of Obstetricians and Gynecologists.

“Immediate postpartum LARC should be offered as an effective option for postpartum contraception; there are few contraindications to postpartum IUDs and implants,” according to the statement issued by ACOG’s Committee on Obstetric Practice (Obstet Gynecol. 2016;128:e32-37).

flocu/ThinkStock.com

Unintended pregnancies account for approximately 45% of pregnancies in the United States overall, and at least 70% of pregnancies in the first year post partum, the committee noted.

The statement recommends prenatal counseling about the risks and benefits of LARCs, along with alternatives, to help patients make informed decisions. The committee emphasized that health care providers “should counsel women about the convenience and effectiveness of immediate postpartum LARC, as well as the benefits of reducing unintended pregnancy and lengthening pregnancy intervals.”

However, immediate postpartum use of IUDs is contraindicated in women with intrauterine infection at delivery, postpartum hemorrhage, and puerperal sepsis.

The committee called for systems to provide LARC at the comprehensive postpartum visit if necessary, and recommended stocking LARC devices in labor and delivery units for immediate postpartum placement. In addition, coding and reimbursement strategies are needed to support immediate postpartum LARC, according to the statement.

The policy statement was endorsed by the American College of Nurse-Midwives and the Society for Maternal-Fetal Medicine.

Use of long-acting reversible contraception immediately post partum can help reduce the risk of unintended and short-interval pregnancy, according to a new policy statement from the American College of Obstetricians and Gynecologists.

“Immediate postpartum LARC should be offered as an effective option for postpartum contraception; there are few contraindications to postpartum IUDs and implants,” according to the statement issued by ACOG’s Committee on Obstetric Practice (Obstet Gynecol. 2016;128:e32-37).

flocu/ThinkStock.com

Unintended pregnancies account for approximately 45% of pregnancies in the United States overall, and at least 70% of pregnancies in the first year post partum, the committee noted.

The statement recommends prenatal counseling about the risks and benefits of LARCs, along with alternatives, to help patients make informed decisions. The committee emphasized that health care providers “should counsel women about the convenience and effectiveness of immediate postpartum LARC, as well as the benefits of reducing unintended pregnancy and lengthening pregnancy intervals.”

However, immediate postpartum use of IUDs is contraindicated in women with intrauterine infection at delivery, postpartum hemorrhage, and puerperal sepsis.

The committee called for systems to provide LARC at the comprehensive postpartum visit if necessary, and recommended stocking LARC devices in labor and delivery units for immediate postpartum placement. In addition, coding and reimbursement strategies are needed to support immediate postpartum LARC, according to the statement.

The policy statement was endorsed by the American College of Nurse-Midwives and the Society for Maternal-Fetal Medicine.

Acinetobacter baumanii was the most common cause of ventilator-associated pneumonia in ICU patients, and the risk of A. baumannii infection was significantly higher when airways were colonized with Candida species, based on data from 618 adults.

A. baumannii is a frequent cause of ventilator-associated pneumonia (VAP) in ICU patients, but its potential interactions with Candida species have not been well studied, wrote Dr. Xiaojiang Tan of Southern Medical University, Guangzhou, China, and colleagues (Med Mycol. 2016 Aug 1;54[6]:557-66. doi: 10.1093/mmy/myw009). The researchers reviewed data from 264 ICU patients on mechanical ventilation who had Candida species airway colonization and 354 who did not.

Overall, Candida was an independent risk factor for A. baumannii VAP; patients with Candida were significantly more likely than those without Candida to develop A. baumannii (23% vs. 15%). Other independent risk factors for A. baumannii VAP included the use of a central venous catheter and the use of mechanical ventilation for at least 7 days. Among patients on mechanical ventilation for at least 48 hours, Candida airway colonization occurred in 43%, and A. baumannii VAP occurred in 18%.

GrahamColm/Wikimedia Commons

Candida albicans showed an especially strong association with A. baumannii VAP; it was identified in 38% of cases, compared with 21% caused by non-albicans species.

No significant differences in hospital stay or in-hospital mortality were noted between Candida-colonized and noncolonized patients, and antifungal treatment had no apparent impact on the development of A. baumannii VAP, but antifungals were associated with higher in-hospital mortality (53% vs. 39%, P = .037).

The results were limited by the retrospective nature of the study and the use of data from a single center; thus, the relationship between Candida and A. baumannii VAP may not be generalizable, the researchers noted. However, “the strong independent association between the two suggests that Candida spp. growth from the lower respiratory tract in intubated patients could be an important indicator of the risk for VAP, and even that C. albicans airway colonization may play a role in subsequent development of A. baumannii VAP,” they wrote.

The researchers reported having no relevant financial conflicts.

Acinetobacter baumanii was the most common cause of ventilator-associated pneumonia in ICU patients, and the risk of A. baumannii infection was significantly higher when airways were colonized with Candida species, based on data from 618 adults.

A. baumannii is a frequent cause of ventilator-associated pneumonia (VAP) in ICU patients, but its potential interactions with Candida species have not been well studied, wrote Dr. Xiaojiang Tan of Southern Medical University, Guangzhou, China, and colleagues (Med Mycol. 2016 Aug 1;54[6]:557-66. doi: 10.1093/mmy/myw009). The researchers reviewed data from 264 ICU patients on mechanical ventilation who had Candida species airway colonization and 354 who did not.

Overall, Candida was an independent risk factor for A. baumannii VAP; patients with Candida were significantly more likely than those without Candida to develop A. baumannii (23% vs. 15%). Other independent risk factors for A. baumannii VAP included the use of a central venous catheter and the use of mechanical ventilation for at least 7 days. Among patients on mechanical ventilation for at least 48 hours, Candida airway colonization occurred in 43%, and A. baumannii VAP occurred in 18%.

GrahamColm/Wikimedia Commons

Candida albicans showed an especially strong association with A. baumannii VAP; it was identified in 38% of cases, compared with 21% caused by non-albicans species.

No significant differences in hospital stay or in-hospital mortality were noted between Candida-colonized and noncolonized patients, and antifungal treatment had no apparent impact on the development of A. baumannii VAP, but antifungals were associated with higher in-hospital mortality (53% vs. 39%, P = .037).

The results were limited by the retrospective nature of the study and the use of data from a single center; thus, the relationship between Candida and A. baumannii VAP may not be generalizable, the researchers noted. However, “the strong independent association between the two suggests that Candida spp. growth from the lower respiratory tract in intubated patients could be an important indicator of the risk for VAP, and even that C. albicans airway colonization may play a role in subsequent development of A. baumannii VAP,” they wrote.

The researchers reported having no relevant financial conflicts.

Acinetobacter baumanii was the most common cause of ventilator-associated pneumonia in ICU patients, and the risk of A. baumannii infection was significantly higher when airways were colonized with Candida species, based on data from 618 adults.

A. baumannii is a frequent cause of ventilator-associated pneumonia (VAP) in ICU patients, but its potential interactions with Candida species have not been well studied, wrote Dr. Xiaojiang Tan of Southern Medical University, Guangzhou, China, and colleagues (Med Mycol. 2016 Aug 1;54[6]:557-66. doi: 10.1093/mmy/myw009). The researchers reviewed data from 264 ICU patients on mechanical ventilation who had Candida species airway colonization and 354 who did not.

Overall, Candida was an independent risk factor for A. baumannii VAP; patients with Candida were significantly more likely than those without Candida to develop A. baumannii (23% vs. 15%). Other independent risk factors for A. baumannii VAP included the use of a central venous catheter and the use of mechanical ventilation for at least 7 days. Among patients on mechanical ventilation for at least 48 hours, Candida airway colonization occurred in 43%, and A. baumannii VAP occurred in 18%.

GrahamColm/Wikimedia Commons

Candida albicans showed an especially strong association with A. baumannii VAP; it was identified in 38% of cases, compared with 21% caused by non-albicans species.

No significant differences in hospital stay or in-hospital mortality were noted between Candida-colonized and noncolonized patients, and antifungal treatment had no apparent impact on the development of A. baumannii VAP, but antifungals were associated with higher in-hospital mortality (53% vs. 39%, P = .037).

The results were limited by the retrospective nature of the study and the use of data from a single center; thus, the relationship between Candida and A. baumannii VAP may not be generalizable, the researchers noted. However, “the strong independent association between the two suggests that Candida spp. growth from the lower respiratory tract in intubated patients could be an important indicator of the risk for VAP, and even that C. albicans airway colonization may play a role in subsequent development of A. baumannii VAP,” they wrote.

The researchers reported having no relevant financial conflicts.

The cognitive effects of estrogen were no different in women who started taking the hormone within 6 years of menopause, compared with those who began it 10 or more years after menopause, based on data from the double-blind randomized ELITE-Cog trial.

“Some hormone effects on cognition are postulated to vary by age or by timing in relation to the menopause,” wrote Victor W. Henderson, M.D., of Stanford (Calif.) University and his colleagues (Neurology. 2016 Jul 20. doi: 10.1212/WNL.0000000000002980).

©Highwaystarz-Photography/Thinkstock

To test whether the timing of estrogen therapy affected the primary cognitive endpoint of verbal episodic memory, the researchers conducted the ELITE (Early vs. Late Intervention Trial With Estradiol) trial in which they randomized 567 healthy women within 6 years of menopause or 10 or more years post menopause to 1 mg/day of oral 17-beta-estradiol or a placebo. Women with a uterus also received either 45 mg progesterone as a 4% vaginal gel or a matched placebo gel.

The main ELITE trial tested the effect of the timing of estradiol, compared with placebo, on the progression of subclinical atherosclerosis, whereas the ELITE-Cog trial assessed the effects of the timing of estradiol on a composite test of verbal episodic memory.

Overall, composite scores of verbal memory were not significantly different in women randomized to estrogen vs. placebo based on a mean standardized difference of –0.06 (95% confidence interval, –0.22 to 0.09) after an average of 57 months of treatment. The mean standardized difference was similar in the early and late treatment groups. In addition, the mean standardized differences in measures of executive functions (–0.04; 95% CI, –0.21 to 0.14) and global cognition (–0.025; 95% CI, –0.18 to 0.13) were not significantly different between women who started estrogen within 6 years of menopause and those who started estrogen 10 years or more after menopause. Safety profiles were similar between the groups.

“Results of this randomized, double-blind placebo-controlled trial fail to confirm the timing hypothesis for cognitive outcomes in healthy postmenopausal women,” the researchers wrote.

The results don’t generalize to other subgroups including women of reproductive age, those in transition to menopause, or those with premature menopause caused by surgery or chemotherapy, and the study “was not designed to assess short-term cognitive effects of estradiol or effects on risks of mild cognitive impairment or Alzheimer disease,” the researchers noted. However, the findings should be reassuring to healthy, younger postmenopausal women considering estrogen therapy, they said.

The study was supported by a grant from the National Institutes of Health, and the study drugs and placebo were supplied by Teva, Watson, and Abbott Laboratories. Dr. Henderson disclosed research support from the NIH, as well as travel expenses from the NIH, American Academy of Neurology, and International Menopause Society.

The cognitive effects of estrogen were no different in women who started taking the hormone within 6 years of menopause, compared with those who began it 10 or more years after menopause, based on data from the double-blind randomized ELITE-Cog trial.

“Some hormone effects on cognition are postulated to vary by age or by timing in relation to the menopause,” wrote Victor W. Henderson, M.D., of Stanford (Calif.) University and his colleagues (Neurology. 2016 Jul 20. doi: 10.1212/WNL.0000000000002980).

©Highwaystarz-Photography/Thinkstock

To test whether the timing of estrogen therapy affected the primary cognitive endpoint of verbal episodic memory, the researchers conducted the ELITE (Early vs. Late Intervention Trial With Estradiol) trial in which they randomized 567 healthy women within 6 years of menopause or 10 or more years post menopause to 1 mg/day of oral 17-beta-estradiol or a placebo. Women with a uterus also received either 45 mg progesterone as a 4% vaginal gel or a matched placebo gel.

The main ELITE trial tested the effect of the timing of estradiol, compared with placebo, on the progression of subclinical atherosclerosis, whereas the ELITE-Cog trial assessed the effects of the timing of estradiol on a composite test of verbal episodic memory.

Overall, composite scores of verbal memory were not significantly different in women randomized to estrogen vs. placebo based on a mean standardized difference of –0.06 (95% confidence interval, –0.22 to 0.09) after an average of 57 months of treatment. The mean standardized difference was similar in the early and late treatment groups. In addition, the mean standardized differences in measures of executive functions (–0.04; 95% CI, –0.21 to 0.14) and global cognition (–0.025; 95% CI, –0.18 to 0.13) were not significantly different between women who started estrogen within 6 years of menopause and those who started estrogen 10 years or more after menopause. Safety profiles were similar between the groups.

“Results of this randomized, double-blind placebo-controlled trial fail to confirm the timing hypothesis for cognitive outcomes in healthy postmenopausal women,” the researchers wrote.

The results don’t generalize to other subgroups including women of reproductive age, those in transition to menopause, or those with premature menopause caused by surgery or chemotherapy, and the study “was not designed to assess short-term cognitive effects of estradiol or effects on risks of mild cognitive impairment or Alzheimer disease,” the researchers noted. However, the findings should be reassuring to healthy, younger postmenopausal women considering estrogen therapy, they said.

The study was supported by a grant from the National Institutes of Health, and the study drugs and placebo were supplied by Teva, Watson, and Abbott Laboratories. Dr. Henderson disclosed research support from the NIH, as well as travel expenses from the NIH, American Academy of Neurology, and International Menopause Society.

The cognitive effects of estrogen were no different in women who started taking the hormone within 6 years of menopause, compared with those who began it 10 or more years after menopause, based on data from the double-blind randomized ELITE-Cog trial.

“Some hormone effects on cognition are postulated to vary by age or by timing in relation to the menopause,” wrote Victor W. Henderson, M.D., of Stanford (Calif.) University and his colleagues (Neurology. 2016 Jul 20. doi: 10.1212/WNL.0000000000002980).

©Highwaystarz-Photography/Thinkstock

To test whether the timing of estrogen therapy affected the primary cognitive endpoint of verbal episodic memory, the researchers conducted the ELITE (Early vs. Late Intervention Trial With Estradiol) trial in which they randomized 567 healthy women within 6 years of menopause or 10 or more years post menopause to 1 mg/day of oral 17-beta-estradiol or a placebo. Women with a uterus also received either 45 mg progesterone as a 4% vaginal gel or a matched placebo gel.

The main ELITE trial tested the effect of the timing of estradiol, compared with placebo, on the progression of subclinical atherosclerosis, whereas the ELITE-Cog trial assessed the effects of the timing of estradiol on a composite test of verbal episodic memory.

Overall, composite scores of verbal memory were not significantly different in women randomized to estrogen vs. placebo based on a mean standardized difference of –0.06 (95% confidence interval, –0.22 to 0.09) after an average of 57 months of treatment. The mean standardized difference was similar in the early and late treatment groups. In addition, the mean standardized differences in measures of executive functions (–0.04; 95% CI, –0.21 to 0.14) and global cognition (–0.025; 95% CI, –0.18 to 0.13) were not significantly different between women who started estrogen within 6 years of menopause and those who started estrogen 10 years or more after menopause. Safety profiles were similar between the groups.

“Results of this randomized, double-blind placebo-controlled trial fail to confirm the timing hypothesis for cognitive outcomes in healthy postmenopausal women,” the researchers wrote.

The results don’t generalize to other subgroups including women of reproductive age, those in transition to menopause, or those with premature menopause caused by surgery or chemotherapy, and the study “was not designed to assess short-term cognitive effects of estradiol or effects on risks of mild cognitive impairment or Alzheimer disease,” the researchers noted. However, the findings should be reassuring to healthy, younger postmenopausal women considering estrogen therapy, they said.

The study was supported by a grant from the National Institutes of Health, and the study drugs and placebo were supplied by Teva, Watson, and Abbott Laboratories. Dr. Henderson disclosed research support from the NIH, as well as travel expenses from the NIH, American Academy of Neurology, and International Menopause Society.

Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.

In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.

©KUO CHUN HUNG/Thinkstock

A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.

“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.

The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.

Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.

Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.

In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.

For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.

Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.

Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.

Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.

The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”

The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.

The final recommendation statement is available online at USPSTF.

Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.

In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.

©KUO CHUN HUNG/Thinkstock

A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.

“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.

The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.

Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.

Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.

In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.

For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.

Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.

Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.

Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.

The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”

The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.

The final recommendation statement is available online at USPSTF.

Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.

In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.

©KUO CHUN HUNG/Thinkstock

A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.

“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.

The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.

Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.

Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.

In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.

For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.

Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.

Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.

Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.

The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”

The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.

The final recommendation statement is available online at USPSTF.