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Ezetimibe’s ACS benefit centers on high-risk, post-CABG patients
ROME – Patients who have undergone coronary artery bypass surgery and who later have an acute coronary syndrome event gain the most from an aggressive lipid-lowering regimen, according to an exploratory analysis of data from more than 18,000 patients enrolled in the IMPROVE-IT trial that tested the incremental benefit from ezetimibe treatment when added to a statin.
Additional exploratory analyses further showed that high-risk acute coronary syndrome (ACS) patients without a history of coronary artery bypass grafting (CABG) also benefited from adding ezetimibe to a background regimen of simvastatin, but the benefit from adding ezetimibe completely disappeared in low-risk ACS patients, Alon Eisen, MD, said at the annual congress of the European Society of Cardiology.
‘The benefit of adding ezetimibe to a statin was enhanced in patients with prior CABG and in other high-risk patients with no prior CABG, supporting the use of more intensive lipid-lowering therapy in these high-risk patients,” said Dr. Eisen, a cardiologist at Brigham and Women’s Hospital in Boston. He also highlighted that ezetimibe is “a safe drug that is coming off patent.” Adding ezetimibe had a moderate effect on LDL cholesterol levels, cutting them from a median of 70 mg/dL in patients in the placebo arm to a median of 54 mg/dL in the group who received ezetimibe.
These results “show that if we pick the right patients, a very benign drug can have a great benefit,” said Eugene Braunwald, MD, a coinvestigator on the IMPROVE-IT trial and a collaborator with Dr. Eisen on the new analysis. The new findings “emphasize that the higher a patient’s risk, the more effect they get from cholesterol-lowering treatment,” said Dr. Braunwald, professor of medicine at Harvard University and a cardiologist at Brigham and Women’s Hospital, both in Boston.
The second exploratory analysis reported by Dr. Eisen looked at the more than 16,000 patients in IMPROVE-IT without history of CABG. The analysis applied a newly developed, nine-item formula for stratifying atherothrombotic risk (Circulation. 2016 July 26;134[4];304-13) to divide these patients into low-, intermediate- and high-risk subgroups. Patients in the high-risk subgroup (20% of the IMPROVE-IT subgroup) had a 6–percentage point reduction in their primary endpoint event rate with added ezetimibe treatment, while those at intermediate risk (31%) got a 2–percentage point decrease in endpoint events, and low-risk patients (49%) actually showed a small, less than 1–percentage point increase in endpoint events with added ezetimibe, Dr. Eisen reported.
IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
[email protected]
On Twitter @mitchelzoler
I suspect that the patients in IMPROVE-IT with a history of coronary artery bypass graft surgery were more likely than the other enrolled acute coronary syndrome patients to have more extensive and systemic atherosclerotic disease. Although coronary artery bypass addresses the most acute obstructions to coronary flow that exist at the time of surgery, the procedure does not cure the patient’s underlying vascular disease. We know that a substantial majority of coronary events occur in arteries that are not heavily stenosed.
Another important limitation to keep in mind about the IMPROVE-IT trial was that the background statin treatment all patients received was modest – 40 mg of simvastatin daily. In real-world practice, high-risk patients should go on the most potent statin regimen they can tolerate – ideally, 40 mg daily of rosuvastatin. The need for additional lipid-lowering interventions, with ezetimibe or other drugs, can then be considered as an add-on to aggressive statin therapy.
Richard A. Chazal, MD, is an invasive cardiologist and medical director of the Heart and Vascular Institute of Lee Memorial Health System in Fort Myers, Fla. He is also the current president of the American College of Cardiology. He had no disclosures. He made these comments in an interview.
I suspect that the patients in IMPROVE-IT with a history of coronary artery bypass graft surgery were more likely than the other enrolled acute coronary syndrome patients to have more extensive and systemic atherosclerotic disease. Although coronary artery bypass addresses the most acute obstructions to coronary flow that exist at the time of surgery, the procedure does not cure the patient’s underlying vascular disease. We know that a substantial majority of coronary events occur in arteries that are not heavily stenosed.
Another important limitation to keep in mind about the IMPROVE-IT trial was that the background statin treatment all patients received was modest – 40 mg of simvastatin daily. In real-world practice, high-risk patients should go on the most potent statin regimen they can tolerate – ideally, 40 mg daily of rosuvastatin. The need for additional lipid-lowering interventions, with ezetimibe or other drugs, can then be considered as an add-on to aggressive statin therapy.
Richard A. Chazal, MD, is an invasive cardiologist and medical director of the Heart and Vascular Institute of Lee Memorial Health System in Fort Myers, Fla. He is also the current president of the American College of Cardiology. He had no disclosures. He made these comments in an interview.
I suspect that the patients in IMPROVE-IT with a history of coronary artery bypass graft surgery were more likely than the other enrolled acute coronary syndrome patients to have more extensive and systemic atherosclerotic disease. Although coronary artery bypass addresses the most acute obstructions to coronary flow that exist at the time of surgery, the procedure does not cure the patient’s underlying vascular disease. We know that a substantial majority of coronary events occur in arteries that are not heavily stenosed.
Another important limitation to keep in mind about the IMPROVE-IT trial was that the background statin treatment all patients received was modest – 40 mg of simvastatin daily. In real-world practice, high-risk patients should go on the most potent statin regimen they can tolerate – ideally, 40 mg daily of rosuvastatin. The need for additional lipid-lowering interventions, with ezetimibe or other drugs, can then be considered as an add-on to aggressive statin therapy.
Richard A. Chazal, MD, is an invasive cardiologist and medical director of the Heart and Vascular Institute of Lee Memorial Health System in Fort Myers, Fla. He is also the current president of the American College of Cardiology. He had no disclosures. He made these comments in an interview.
ROME – Patients who have undergone coronary artery bypass surgery and who later have an acute coronary syndrome event gain the most from an aggressive lipid-lowering regimen, according to an exploratory analysis of data from more than 18,000 patients enrolled in the IMPROVE-IT trial that tested the incremental benefit from ezetimibe treatment when added to a statin.
Additional exploratory analyses further showed that high-risk acute coronary syndrome (ACS) patients without a history of coronary artery bypass grafting (CABG) also benefited from adding ezetimibe to a background regimen of simvastatin, but the benefit from adding ezetimibe completely disappeared in low-risk ACS patients, Alon Eisen, MD, said at the annual congress of the European Society of Cardiology.
‘The benefit of adding ezetimibe to a statin was enhanced in patients with prior CABG and in other high-risk patients with no prior CABG, supporting the use of more intensive lipid-lowering therapy in these high-risk patients,” said Dr. Eisen, a cardiologist at Brigham and Women’s Hospital in Boston. He also highlighted that ezetimibe is “a safe drug that is coming off patent.” Adding ezetimibe had a moderate effect on LDL cholesterol levels, cutting them from a median of 70 mg/dL in patients in the placebo arm to a median of 54 mg/dL in the group who received ezetimibe.
These results “show that if we pick the right patients, a very benign drug can have a great benefit,” said Eugene Braunwald, MD, a coinvestigator on the IMPROVE-IT trial and a collaborator with Dr. Eisen on the new analysis. The new findings “emphasize that the higher a patient’s risk, the more effect they get from cholesterol-lowering treatment,” said Dr. Braunwald, professor of medicine at Harvard University and a cardiologist at Brigham and Women’s Hospital, both in Boston.
The second exploratory analysis reported by Dr. Eisen looked at the more than 16,000 patients in IMPROVE-IT without history of CABG. The analysis applied a newly developed, nine-item formula for stratifying atherothrombotic risk (Circulation. 2016 July 26;134[4];304-13) to divide these patients into low-, intermediate- and high-risk subgroups. Patients in the high-risk subgroup (20% of the IMPROVE-IT subgroup) had a 6–percentage point reduction in their primary endpoint event rate with added ezetimibe treatment, while those at intermediate risk (31%) got a 2–percentage point decrease in endpoint events, and low-risk patients (49%) actually showed a small, less than 1–percentage point increase in endpoint events with added ezetimibe, Dr. Eisen reported.
IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
[email protected]
On Twitter @mitchelzoler
ROME – Patients who have undergone coronary artery bypass surgery and who later have an acute coronary syndrome event gain the most from an aggressive lipid-lowering regimen, according to an exploratory analysis of data from more than 18,000 patients enrolled in the IMPROVE-IT trial that tested the incremental benefit from ezetimibe treatment when added to a statin.
Additional exploratory analyses further showed that high-risk acute coronary syndrome (ACS) patients without a history of coronary artery bypass grafting (CABG) also benefited from adding ezetimibe to a background regimen of simvastatin, but the benefit from adding ezetimibe completely disappeared in low-risk ACS patients, Alon Eisen, MD, said at the annual congress of the European Society of Cardiology.
‘The benefit of adding ezetimibe to a statin was enhanced in patients with prior CABG and in other high-risk patients with no prior CABG, supporting the use of more intensive lipid-lowering therapy in these high-risk patients,” said Dr. Eisen, a cardiologist at Brigham and Women’s Hospital in Boston. He also highlighted that ezetimibe is “a safe drug that is coming off patent.” Adding ezetimibe had a moderate effect on LDL cholesterol levels, cutting them from a median of 70 mg/dL in patients in the placebo arm to a median of 54 mg/dL in the group who received ezetimibe.
These results “show that if we pick the right patients, a very benign drug can have a great benefit,” said Eugene Braunwald, MD, a coinvestigator on the IMPROVE-IT trial and a collaborator with Dr. Eisen on the new analysis. The new findings “emphasize that the higher a patient’s risk, the more effect they get from cholesterol-lowering treatment,” said Dr. Braunwald, professor of medicine at Harvard University and a cardiologist at Brigham and Women’s Hospital, both in Boston.
The second exploratory analysis reported by Dr. Eisen looked at the more than 16,000 patients in IMPROVE-IT without history of CABG. The analysis applied a newly developed, nine-item formula for stratifying atherothrombotic risk (Circulation. 2016 July 26;134[4];304-13) to divide these patients into low-, intermediate- and high-risk subgroups. Patients in the high-risk subgroup (20% of the IMPROVE-IT subgroup) had a 6–percentage point reduction in their primary endpoint event rate with added ezetimibe treatment, while those at intermediate risk (31%) got a 2–percentage point decrease in endpoint events, and low-risk patients (49%) actually showed a small, less than 1–percentage point increase in endpoint events with added ezetimibe, Dr. Eisen reported.
IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
[email protected]
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2016
Key clinical point:
Major finding: The absolute primary-event risk reduction was 9% in post-CABG patients and 1% in all other patients.
Data source: An exploratory, post-hoc analysis of data collected in IMPROVE-IT, a multicenter trial with 18,144 patients.
Disclosures: IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
Drug prices, not the health law, top voters’ health priorities for 2017
Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.
The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)
By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.
Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”
The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.
As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).
Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.
The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.
This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.
The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)
By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.
Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”
The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.
As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).
Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.
The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.
This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.
The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)
By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.
Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”
The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.
As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).
Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.
The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.
This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
FDA expands indication for pembrolizumab in NSCLC
The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.
Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.
The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).
In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.
The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.
The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.
Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.
The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).
In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.
The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.
The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.
Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.
The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).
In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.
The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.
The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
Inhaled antibiotic for bronchiectasis shows promise
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
Key clinical point:
Major finding: Compared with patients in the placebo arm, those in the ciprofloxacin 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days vs. 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005).
Data source: A multicenter study of 416 patients who were randomized 2:1 to ciprofloxacin 32.5 mg or placebo administered twice per day using a pocket-sized inhaler as a cyclical regimen of either 14 days on/off drug or 28 days on/off drug, for 48 weeks.
Disclosures: RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
Lung cancer screening found effective in a community hospital
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Of nine lung cancers detected, seven (78%) were stage I or II lung cancers and the remaining two (22%) were stage II or IV.
Data source: Results from 514 patients enrolled in a community hospital–based lung cancer screening program between July 2013 and December 2015.
Disclosures: Dr. Salzano reported having no relevant financial disclosures.
Joint European atrial fibrillation guidelines break new ground
ROME – The 2016 joint European guidelines on management of atrial fibrillation break new ground by declaring as a strong Class IA recommendation that the novel oral anticoagulants are now the drugs of choice – preferred over warfarin – for stroke prevention.
The joint guidelines from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery recommend that warfarin’s use be reserved for the relatively small proportion of atrial fibrillation (AF) patients who are ineligible for the four commercially available novel oral anticoagulants (NOACs). That’s mainly patients with mechanical heart valves, moderate to severe mitral stenosis, or severe chronic kidney disease.
The ESC/EACTS guidelines, taken together with the American College of Chest Physicians guidelines on antithrombotic therapy for venous thromboembolic disease released earlier in the year, suggest that the old war horse warfarin is being eased out to pasture. The ACCP guidelines recommend any of the four NOACS – apixaban, dabigatran, edoxaban, or rivaroxaban – be used preferentially over warfarin in the treatment of venous thromboembolism (Chest 2016 Feb;149[2]:315-52). Both sets of guidelines cite compelling evidence that the NOACs are significantly safer than warfarin yet equally effective.
The ESC/EACTS guidelines are a full rewrite containing numerous departures from the previous 2012 AF management guidelines as well as from current ACC/AHA guidelines. The report includes more than 1,000 references. Eighty percent of the 154 recommendations provide Class I or IIa guidance. Two-thirds of the recommendations are Level of Evidence A or B, task force chairperson Paulus Kirchhof, MD, said at the annual congress of the European Society of Cardiology.
He and co-chairperson Stefano Benussi, MD, presented some of the highlights.
The guidelines issue a strong call for greater use of targeted ECG screening in populations at risk for silent AF, including stroke survivors and the elderly. And AF should always be documented before starting treatment, given that all of the treatments carry risk, said Dr. Kirchhof, professor of cardiovascular medicine at the University of Birmingham (England).
Once the diagnosis is established, it’s essential to address in a structured way five domains of management: acute rate and rhythm control; management of precipitating factors, including underlying cardiovascular conditions such as hypertension or valvular heart disease; assessment of stroke risk using the CHA2DS2-VASc scoring system; assessment of heart rate; and evaluation of the impact of AF symptoms on the patient’s life, including fatigue and breathlessness, using a structured instrument such as the modified European Heart Rhythm Association symptom scale.
Men with a CHA2DS2-VASc score of 1 and women with a score of 2 should be considered for anticoagulation. And the treatment should be recommended – not merely considered – for men with a score of 2 or more and women with a score of 3; that’s a Class Ia recommendation, Dr. Kirchhof continued.
The use of a specific bleeding risk score is no longer recommended in AF patients on oral anticoagulation. The emphasis has shifted to reduction of modifiable bleeding risk factors, including limiting alcohol intake to fewer than 8 drinks per week, control of hypertension, and discontinuing antiplatelet and anti-inflammatory agents.
Consideration of left atrial appendage occlusion devices should be reserved for the small percentage of patients who have clear contraindications to all forms of oral anticoagulation.
The task force concluded that patients who have bleeding on oral anticoagulation can often be managed with local therapy and discontinuation of anticoagulation therapy for a day or two before resumption. However, decisions regarding resumption of a NOAC or warfarin after an intracranial bleed should be handled by an interdisciplinary panel composed of a stroke neurologist, a cardiologist, a neuroradiologist, and a neurosurgeon.
Evidence-based treatment options in patients with symptomatic AF after failed catheter ablation include minimally invasive surgery with epicardial pulmonary vein isolation, more extensive catheter ablation, and hybrid procedures, according to Dr. Benussi, who is codirector of clinical cardiovascular surgery at University Hospital in Zurich.
The guidelines state that the data supporting catheter ablation to achieve long-term rhythm control are now sufficiently strong that this intervention should be considered as a first-line option alongside antiarrhythmic drugs as a matter of patient preference in the setting of symptomatic paroxysmal AF regardless of whether the patient has CAD, heart failure, valvular heart disease, or no structural heart disease.
Catheter ablation using radiofrequency energy or cryoablation should target complete isolation of the pulmonary veins.
“Additional ablation lines do not provide demonstrable clinical benefit and increase the risk of postablation left atrial arrhythmias,” the surgeon said.
Maze surgery, preferably biatrial, received a favorable Class IIa, Level of Evidence A recommendation as worthy of consideration in patients with symptomatic AF who are already undergoing cardiac surgery. This recommendation was based upon an external review by the Cochrane group which was commissioned by the guidelines task force. The Cochrane review of eight published studies concluded that Maze surgery under such circumstances was associated with a twofold increased freedom from AF, atrial flutter, and atrial tachycardia (Cochrane Database of Systematic Reviews 2016;8: CD012088. doi: 10.1002/14651858.CD012088.pub2).
The AF management guidelines are supported by the ESC Pocket Guidelines app, which includes an overall AF treatment manager developed by the European Union–funded CATCH ME (Characterizing Atrial Fibrillation by Translating its Causes Into Health Modifiers in the Elderly) project.
The multidisciplinary 17-member AF management task force was drawn from cardiology, stroke neurology, cardiac surgery, and specialist nursing. Dr. Kirchhof stressed that only recommendations supported by at least 75% of task force members made it into the guidelines (Eur Heart J. 2016 Aug 27. pii: ehw210. [Epub ahead of print] doi: 10.1093/eurheartj/ehw210).
ROME – The 2016 joint European guidelines on management of atrial fibrillation break new ground by declaring as a strong Class IA recommendation that the novel oral anticoagulants are now the drugs of choice – preferred over warfarin – for stroke prevention.
The joint guidelines from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery recommend that warfarin’s use be reserved for the relatively small proportion of atrial fibrillation (AF) patients who are ineligible for the four commercially available novel oral anticoagulants (NOACs). That’s mainly patients with mechanical heart valves, moderate to severe mitral stenosis, or severe chronic kidney disease.
The ESC/EACTS guidelines, taken together with the American College of Chest Physicians guidelines on antithrombotic therapy for venous thromboembolic disease released earlier in the year, suggest that the old war horse warfarin is being eased out to pasture. The ACCP guidelines recommend any of the four NOACS – apixaban, dabigatran, edoxaban, or rivaroxaban – be used preferentially over warfarin in the treatment of venous thromboembolism (Chest 2016 Feb;149[2]:315-52). Both sets of guidelines cite compelling evidence that the NOACs are significantly safer than warfarin yet equally effective.
The ESC/EACTS guidelines are a full rewrite containing numerous departures from the previous 2012 AF management guidelines as well as from current ACC/AHA guidelines. The report includes more than 1,000 references. Eighty percent of the 154 recommendations provide Class I or IIa guidance. Two-thirds of the recommendations are Level of Evidence A or B, task force chairperson Paulus Kirchhof, MD, said at the annual congress of the European Society of Cardiology.
He and co-chairperson Stefano Benussi, MD, presented some of the highlights.
The guidelines issue a strong call for greater use of targeted ECG screening in populations at risk for silent AF, including stroke survivors and the elderly. And AF should always be documented before starting treatment, given that all of the treatments carry risk, said Dr. Kirchhof, professor of cardiovascular medicine at the University of Birmingham (England).
Once the diagnosis is established, it’s essential to address in a structured way five domains of management: acute rate and rhythm control; management of precipitating factors, including underlying cardiovascular conditions such as hypertension or valvular heart disease; assessment of stroke risk using the CHA2DS2-VASc scoring system; assessment of heart rate; and evaluation of the impact of AF symptoms on the patient’s life, including fatigue and breathlessness, using a structured instrument such as the modified European Heart Rhythm Association symptom scale.
Men with a CHA2DS2-VASc score of 1 and women with a score of 2 should be considered for anticoagulation. And the treatment should be recommended – not merely considered – for men with a score of 2 or more and women with a score of 3; that’s a Class Ia recommendation, Dr. Kirchhof continued.
The use of a specific bleeding risk score is no longer recommended in AF patients on oral anticoagulation. The emphasis has shifted to reduction of modifiable bleeding risk factors, including limiting alcohol intake to fewer than 8 drinks per week, control of hypertension, and discontinuing antiplatelet and anti-inflammatory agents.
Consideration of left atrial appendage occlusion devices should be reserved for the small percentage of patients who have clear contraindications to all forms of oral anticoagulation.
The task force concluded that patients who have bleeding on oral anticoagulation can often be managed with local therapy and discontinuation of anticoagulation therapy for a day or two before resumption. However, decisions regarding resumption of a NOAC or warfarin after an intracranial bleed should be handled by an interdisciplinary panel composed of a stroke neurologist, a cardiologist, a neuroradiologist, and a neurosurgeon.
Evidence-based treatment options in patients with symptomatic AF after failed catheter ablation include minimally invasive surgery with epicardial pulmonary vein isolation, more extensive catheter ablation, and hybrid procedures, according to Dr. Benussi, who is codirector of clinical cardiovascular surgery at University Hospital in Zurich.
The guidelines state that the data supporting catheter ablation to achieve long-term rhythm control are now sufficiently strong that this intervention should be considered as a first-line option alongside antiarrhythmic drugs as a matter of patient preference in the setting of symptomatic paroxysmal AF regardless of whether the patient has CAD, heart failure, valvular heart disease, or no structural heart disease.
Catheter ablation using radiofrequency energy or cryoablation should target complete isolation of the pulmonary veins.
“Additional ablation lines do not provide demonstrable clinical benefit and increase the risk of postablation left atrial arrhythmias,” the surgeon said.
Maze surgery, preferably biatrial, received a favorable Class IIa, Level of Evidence A recommendation as worthy of consideration in patients with symptomatic AF who are already undergoing cardiac surgery. This recommendation was based upon an external review by the Cochrane group which was commissioned by the guidelines task force. The Cochrane review of eight published studies concluded that Maze surgery under such circumstances was associated with a twofold increased freedom from AF, atrial flutter, and atrial tachycardia (Cochrane Database of Systematic Reviews 2016;8: CD012088. doi: 10.1002/14651858.CD012088.pub2).
The AF management guidelines are supported by the ESC Pocket Guidelines app, which includes an overall AF treatment manager developed by the European Union–funded CATCH ME (Characterizing Atrial Fibrillation by Translating its Causes Into Health Modifiers in the Elderly) project.
The multidisciplinary 17-member AF management task force was drawn from cardiology, stroke neurology, cardiac surgery, and specialist nursing. Dr. Kirchhof stressed that only recommendations supported by at least 75% of task force members made it into the guidelines (Eur Heart J. 2016 Aug 27. pii: ehw210. [Epub ahead of print] doi: 10.1093/eurheartj/ehw210).
ROME – The 2016 joint European guidelines on management of atrial fibrillation break new ground by declaring as a strong Class IA recommendation that the novel oral anticoagulants are now the drugs of choice – preferred over warfarin – for stroke prevention.
The joint guidelines from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery recommend that warfarin’s use be reserved for the relatively small proportion of atrial fibrillation (AF) patients who are ineligible for the four commercially available novel oral anticoagulants (NOACs). That’s mainly patients with mechanical heart valves, moderate to severe mitral stenosis, or severe chronic kidney disease.
The ESC/EACTS guidelines, taken together with the American College of Chest Physicians guidelines on antithrombotic therapy for venous thromboembolic disease released earlier in the year, suggest that the old war horse warfarin is being eased out to pasture. The ACCP guidelines recommend any of the four NOACS – apixaban, dabigatran, edoxaban, or rivaroxaban – be used preferentially over warfarin in the treatment of venous thromboembolism (Chest 2016 Feb;149[2]:315-52). Both sets of guidelines cite compelling evidence that the NOACs are significantly safer than warfarin yet equally effective.
The ESC/EACTS guidelines are a full rewrite containing numerous departures from the previous 2012 AF management guidelines as well as from current ACC/AHA guidelines. The report includes more than 1,000 references. Eighty percent of the 154 recommendations provide Class I or IIa guidance. Two-thirds of the recommendations are Level of Evidence A or B, task force chairperson Paulus Kirchhof, MD, said at the annual congress of the European Society of Cardiology.
He and co-chairperson Stefano Benussi, MD, presented some of the highlights.
The guidelines issue a strong call for greater use of targeted ECG screening in populations at risk for silent AF, including stroke survivors and the elderly. And AF should always be documented before starting treatment, given that all of the treatments carry risk, said Dr. Kirchhof, professor of cardiovascular medicine at the University of Birmingham (England).
Once the diagnosis is established, it’s essential to address in a structured way five domains of management: acute rate and rhythm control; management of precipitating factors, including underlying cardiovascular conditions such as hypertension or valvular heart disease; assessment of stroke risk using the CHA2DS2-VASc scoring system; assessment of heart rate; and evaluation of the impact of AF symptoms on the patient’s life, including fatigue and breathlessness, using a structured instrument such as the modified European Heart Rhythm Association symptom scale.
Men with a CHA2DS2-VASc score of 1 and women with a score of 2 should be considered for anticoagulation. And the treatment should be recommended – not merely considered – for men with a score of 2 or more and women with a score of 3; that’s a Class Ia recommendation, Dr. Kirchhof continued.
The use of a specific bleeding risk score is no longer recommended in AF patients on oral anticoagulation. The emphasis has shifted to reduction of modifiable bleeding risk factors, including limiting alcohol intake to fewer than 8 drinks per week, control of hypertension, and discontinuing antiplatelet and anti-inflammatory agents.
Consideration of left atrial appendage occlusion devices should be reserved for the small percentage of patients who have clear contraindications to all forms of oral anticoagulation.
The task force concluded that patients who have bleeding on oral anticoagulation can often be managed with local therapy and discontinuation of anticoagulation therapy for a day or two before resumption. However, decisions regarding resumption of a NOAC or warfarin after an intracranial bleed should be handled by an interdisciplinary panel composed of a stroke neurologist, a cardiologist, a neuroradiologist, and a neurosurgeon.
Evidence-based treatment options in patients with symptomatic AF after failed catheter ablation include minimally invasive surgery with epicardial pulmonary vein isolation, more extensive catheter ablation, and hybrid procedures, according to Dr. Benussi, who is codirector of clinical cardiovascular surgery at University Hospital in Zurich.
The guidelines state that the data supporting catheter ablation to achieve long-term rhythm control are now sufficiently strong that this intervention should be considered as a first-line option alongside antiarrhythmic drugs as a matter of patient preference in the setting of symptomatic paroxysmal AF regardless of whether the patient has CAD, heart failure, valvular heart disease, or no structural heart disease.
Catheter ablation using radiofrequency energy or cryoablation should target complete isolation of the pulmonary veins.
“Additional ablation lines do not provide demonstrable clinical benefit and increase the risk of postablation left atrial arrhythmias,” the surgeon said.
Maze surgery, preferably biatrial, received a favorable Class IIa, Level of Evidence A recommendation as worthy of consideration in patients with symptomatic AF who are already undergoing cardiac surgery. This recommendation was based upon an external review by the Cochrane group which was commissioned by the guidelines task force. The Cochrane review of eight published studies concluded that Maze surgery under such circumstances was associated with a twofold increased freedom from AF, atrial flutter, and atrial tachycardia (Cochrane Database of Systematic Reviews 2016;8: CD012088. doi: 10.1002/14651858.CD012088.pub2).
The AF management guidelines are supported by the ESC Pocket Guidelines app, which includes an overall AF treatment manager developed by the European Union–funded CATCH ME (Characterizing Atrial Fibrillation by Translating its Causes Into Health Modifiers in the Elderly) project.
The multidisciplinary 17-member AF management task force was drawn from cardiology, stroke neurology, cardiac surgery, and specialist nursing. Dr. Kirchhof stressed that only recommendations supported by at least 75% of task force members made it into the guidelines (Eur Heart J. 2016 Aug 27. pii: ehw210. [Epub ahead of print] doi: 10.1093/eurheartj/ehw210).
Age of blood did not affect mortality in transfused patients
In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.
While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.
Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).
Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.
There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.
An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.
INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.
[email protected]
On Twitter @maryjodales
The results of the INFORM trial should end the debate regarding whether short-term or long-term storage of blood is advantageous. However, questions remain about whether red cells transfused during the last allowed week of storage (35-42 days) pose more risk. Observational studies continue to raise concerns about the use of the oldest blood.
The INFORM trial, with its large numbers of patients, should permit researchers to analyze enough data to address this remaining issue. The transfusion medicine community needs to know whether the storage period should be reduced to less than 35 and whether new preservative solutions should be sought.
Aaron A.R. Tobian, MD, PhD, and Paul M. Ness, MD, are with the division of transfusion medicine, department of pathology, Johns Hopkins University, Baltimore. They had no relevant financial conflicts of interest and made their remarks in an editorial (10.1056/NEJMe1612444) that accompanied the published study.
The results of the INFORM trial should end the debate regarding whether short-term or long-term storage of blood is advantageous. However, questions remain about whether red cells transfused during the last allowed week of storage (35-42 days) pose more risk. Observational studies continue to raise concerns about the use of the oldest blood.
The INFORM trial, with its large numbers of patients, should permit researchers to analyze enough data to address this remaining issue. The transfusion medicine community needs to know whether the storage period should be reduced to less than 35 and whether new preservative solutions should be sought.
Aaron A.R. Tobian, MD, PhD, and Paul M. Ness, MD, are with the division of transfusion medicine, department of pathology, Johns Hopkins University, Baltimore. They had no relevant financial conflicts of interest and made their remarks in an editorial (10.1056/NEJMe1612444) that accompanied the published study.
The results of the INFORM trial should end the debate regarding whether short-term or long-term storage of blood is advantageous. However, questions remain about whether red cells transfused during the last allowed week of storage (35-42 days) pose more risk. Observational studies continue to raise concerns about the use of the oldest blood.
The INFORM trial, with its large numbers of patients, should permit researchers to analyze enough data to address this remaining issue. The transfusion medicine community needs to know whether the storage period should be reduced to less than 35 and whether new preservative solutions should be sought.
Aaron A.R. Tobian, MD, PhD, and Paul M. Ness, MD, are with the division of transfusion medicine, department of pathology, Johns Hopkins University, Baltimore. They had no relevant financial conflicts of interest and made their remarks in an editorial (10.1056/NEJMe1612444) that accompanied the published study.
In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.
While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.
Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).
Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.
There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.
An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.
INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.
[email protected]
On Twitter @maryjodales
In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.
While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.
Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).
Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.
There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.
An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.
INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.
[email protected]
On Twitter @maryjodales
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group.
Data source: The randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial.
Disclosures: INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.
Study links low diastolic blood pressure to myocardial damage, coronary heart disease
Low diastolic blood pressure (DBP) was significantly associated with myocardial injury and incident coronary heart disease, especially when the systolic blood pressure was 120 mm or higher, investigators reported.
Compared with a DBP of 80 to 89 mm Hg, DBP below 60 mm Hg more than doubled the odds of high-sensitivity cardiac troponin-T levels equaling or exceeding 14 ng per mL, and increased the risk of incident coronary heart disease (CHD) by about 50%, in a large observational study. Associations were strongest when baseline systolic blood pressure was at least 120 mm Hg, signifying elevated pulse pressure, reported Dr. John McEvoy of the Ciccarone Center for the Prevention of Heart Disease, Hopkins University, Baltimore, and associates (J Am Coll Cardiol 2016;68[16]:1713–22).
Their study included 11,565 individuals tracked for 21 years through the Atherosclerosis Risk in Communities Cohort, an observational population-based study of adults from in North Carolina, Mississippi, Minnesota, and Maryland. The researchers excluded participants with known baseline cardiovascular disease or heart failure. High-sensitivity cardiac troponin-T levels were measured at three time points between 1990 and 1992, 1996 and 1998, and 2011 and 2013. Participants averaged 57 years old at enrollment, 57% were female, and 25% were black (J Am Coll Cardiol. 2016 Oct 18. doi: 10.1016/j.jacc.2016.07.754).
Compared with baseline DBP of 80 to 89 mm Hg, DBP under 60 mm Hg was associated with a 2.2-fold greater odds (P = .01) of high-sensitivity cardiac troponin-T levels equal to or exceeding 14 ng per mL during the same visit – indicating prevalent myocardial damage – even after controlling for race, sex, body mass index, smoking and alcohol use, triglyceride and cholesterol levels, diabetes, glomerular filtration rate, and use of antihypertensives and lipid-lowering drugs, said the researchers. The odds of myocardial damage remained increased even when DBP was 60 to 69 mm Hg (odds ratio, 1.5; P = .05). Low DBP also was associated with myocardial damage at any given systolic blood pressure.
Furthermore, low DBP significantly increased the risk of progressively worsening myocardial damage, as indicated by a rising annual change in high-sensitivity cardiac troponin-T levels over 6 years. The association was significant as long as DBP was under 80 mm Hg, but was strongest when DBP was less than 60 mm Hg. Diastolic blood pressure under 60 mm Hg also significantly increased the chances of incident CHD and death, but not stroke.
Low DBP was most strongly linked to subclinical myocardial damage and incident CHD when systolic blood pressure was at least 120 mm Hg, indicating elevated pulse pressure, the researchers reported. Systolic pressure is “the main determinant of cardiac afterload and, thus, a primary driver of myocardial energy requirements,” while low DBP reduces myocardial energy supply, they noted. Therefore, high pulse pressure would lead to the greatest mismatch between myocardial energy demand and supply.
“Among patients being treated to SBP goals of 140 mm Hg or lower, attention may need to be paid not only to SBP, but also, importantly, to achieved DBP. Diastolic and systolic BP are inextricably linked, and our results highlighted the importance of not ignoring the former and focusing only on the latter, instead emphasizing the need to consider both in the optimal treatment of adults with hypertension.,”
The study was supported by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases and by the National Heart, Lung, and Blood Institute. Roche Diagnostics provided reagents for the cardiac troponin assays. Dr. McEvoy had no disclosures. One author disclosed ties to Roche; one author disclosed ties to Roche, Abbott Diagnostics, and several other relevant companies; and two authors are coinvestigators on a provisional patent filed by Roche for use of biomarkers in predicting heart failure. The other four authors had no disclosures.
The average age in the study by McEvoy et al. was 57 years. One might anticipate that in an older population, the side effects from lower BPs [blood pressures] due to drug therapy such as hypotension or syncope would be greater, and the potential for adverse cardiovascular events due to a J-curve would be substantially increased compared with what was seen in the present study. Similarly, an exacerbated potential for lower DBP to be harmful might be expected in patients with established coronary artery disease.
The well done study ... shows that lower may not always be better with respect to blood pressure control and, along with other accumulating evidence, strongly suggests careful thought before pushing blood pressure control below current guideline targets, especially if the diastolic blood pressure falls below 60 mm Hg while the pulse pressure is[greater than] 60 mm Hg.
Deepak L. Bhatt, MD, MPH, is at Brigham and Women’s Hospital Heart & Vascular Center, Boston. He disclosed ties to Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Eisai, and a number of other pharmaceutical and medical education companies. His comments are from an accompanying editorial (J Am Coll Cardiol. 2016 Oct 18;68[16]:1723-1726).
The average age in the study by McEvoy et al. was 57 years. One might anticipate that in an older population, the side effects from lower BPs [blood pressures] due to drug therapy such as hypotension or syncope would be greater, and the potential for adverse cardiovascular events due to a J-curve would be substantially increased compared with what was seen in the present study. Similarly, an exacerbated potential for lower DBP to be harmful might be expected in patients with established coronary artery disease.
The well done study ... shows that lower may not always be better with respect to blood pressure control and, along with other accumulating evidence, strongly suggests careful thought before pushing blood pressure control below current guideline targets, especially if the diastolic blood pressure falls below 60 mm Hg while the pulse pressure is[greater than] 60 mm Hg.
Deepak L. Bhatt, MD, MPH, is at Brigham and Women’s Hospital Heart & Vascular Center, Boston. He disclosed ties to Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Eisai, and a number of other pharmaceutical and medical education companies. His comments are from an accompanying editorial (J Am Coll Cardiol. 2016 Oct 18;68[16]:1723-1726).
The average age in the study by McEvoy et al. was 57 years. One might anticipate that in an older population, the side effects from lower BPs [blood pressures] due to drug therapy such as hypotension or syncope would be greater, and the potential for adverse cardiovascular events due to a J-curve would be substantially increased compared with what was seen in the present study. Similarly, an exacerbated potential for lower DBP to be harmful might be expected in patients with established coronary artery disease.
The well done study ... shows that lower may not always be better with respect to blood pressure control and, along with other accumulating evidence, strongly suggests careful thought before pushing blood pressure control below current guideline targets, especially if the diastolic blood pressure falls below 60 mm Hg while the pulse pressure is[greater than] 60 mm Hg.
Deepak L. Bhatt, MD, MPH, is at Brigham and Women’s Hospital Heart & Vascular Center, Boston. He disclosed ties to Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Eisai, and a number of other pharmaceutical and medical education companies. His comments are from an accompanying editorial (J Am Coll Cardiol. 2016 Oct 18;68[16]:1723-1726).
Low diastolic blood pressure (DBP) was significantly associated with myocardial injury and incident coronary heart disease, especially when the systolic blood pressure was 120 mm or higher, investigators reported.
Compared with a DBP of 80 to 89 mm Hg, DBP below 60 mm Hg more than doubled the odds of high-sensitivity cardiac troponin-T levels equaling or exceeding 14 ng per mL, and increased the risk of incident coronary heart disease (CHD) by about 50%, in a large observational study. Associations were strongest when baseline systolic blood pressure was at least 120 mm Hg, signifying elevated pulse pressure, reported Dr. John McEvoy of the Ciccarone Center for the Prevention of Heart Disease, Hopkins University, Baltimore, and associates (J Am Coll Cardiol 2016;68[16]:1713–22).
Their study included 11,565 individuals tracked for 21 years through the Atherosclerosis Risk in Communities Cohort, an observational population-based study of adults from in North Carolina, Mississippi, Minnesota, and Maryland. The researchers excluded participants with known baseline cardiovascular disease or heart failure. High-sensitivity cardiac troponin-T levels were measured at three time points between 1990 and 1992, 1996 and 1998, and 2011 and 2013. Participants averaged 57 years old at enrollment, 57% were female, and 25% were black (J Am Coll Cardiol. 2016 Oct 18. doi: 10.1016/j.jacc.2016.07.754).
Compared with baseline DBP of 80 to 89 mm Hg, DBP under 60 mm Hg was associated with a 2.2-fold greater odds (P = .01) of high-sensitivity cardiac troponin-T levels equal to or exceeding 14 ng per mL during the same visit – indicating prevalent myocardial damage – even after controlling for race, sex, body mass index, smoking and alcohol use, triglyceride and cholesterol levels, diabetes, glomerular filtration rate, and use of antihypertensives and lipid-lowering drugs, said the researchers. The odds of myocardial damage remained increased even when DBP was 60 to 69 mm Hg (odds ratio, 1.5; P = .05). Low DBP also was associated with myocardial damage at any given systolic blood pressure.
Furthermore, low DBP significantly increased the risk of progressively worsening myocardial damage, as indicated by a rising annual change in high-sensitivity cardiac troponin-T levels over 6 years. The association was significant as long as DBP was under 80 mm Hg, but was strongest when DBP was less than 60 mm Hg. Diastolic blood pressure under 60 mm Hg also significantly increased the chances of incident CHD and death, but not stroke.
Low DBP was most strongly linked to subclinical myocardial damage and incident CHD when systolic blood pressure was at least 120 mm Hg, indicating elevated pulse pressure, the researchers reported. Systolic pressure is “the main determinant of cardiac afterload and, thus, a primary driver of myocardial energy requirements,” while low DBP reduces myocardial energy supply, they noted. Therefore, high pulse pressure would lead to the greatest mismatch between myocardial energy demand and supply.
“Among patients being treated to SBP goals of 140 mm Hg or lower, attention may need to be paid not only to SBP, but also, importantly, to achieved DBP. Diastolic and systolic BP are inextricably linked, and our results highlighted the importance of not ignoring the former and focusing only on the latter, instead emphasizing the need to consider both in the optimal treatment of adults with hypertension.,”
The study was supported by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases and by the National Heart, Lung, and Blood Institute. Roche Diagnostics provided reagents for the cardiac troponin assays. Dr. McEvoy had no disclosures. One author disclosed ties to Roche; one author disclosed ties to Roche, Abbott Diagnostics, and several other relevant companies; and two authors are coinvestigators on a provisional patent filed by Roche for use of biomarkers in predicting heart failure. The other four authors had no disclosures.
Low diastolic blood pressure (DBP) was significantly associated with myocardial injury and incident coronary heart disease, especially when the systolic blood pressure was 120 mm or higher, investigators reported.
Compared with a DBP of 80 to 89 mm Hg, DBP below 60 mm Hg more than doubled the odds of high-sensitivity cardiac troponin-T levels equaling or exceeding 14 ng per mL, and increased the risk of incident coronary heart disease (CHD) by about 50%, in a large observational study. Associations were strongest when baseline systolic blood pressure was at least 120 mm Hg, signifying elevated pulse pressure, reported Dr. John McEvoy of the Ciccarone Center for the Prevention of Heart Disease, Hopkins University, Baltimore, and associates (J Am Coll Cardiol 2016;68[16]:1713–22).
Their study included 11,565 individuals tracked for 21 years through the Atherosclerosis Risk in Communities Cohort, an observational population-based study of adults from in North Carolina, Mississippi, Minnesota, and Maryland. The researchers excluded participants with known baseline cardiovascular disease or heart failure. High-sensitivity cardiac troponin-T levels were measured at three time points between 1990 and 1992, 1996 and 1998, and 2011 and 2013. Participants averaged 57 years old at enrollment, 57% were female, and 25% were black (J Am Coll Cardiol. 2016 Oct 18. doi: 10.1016/j.jacc.2016.07.754).
Compared with baseline DBP of 80 to 89 mm Hg, DBP under 60 mm Hg was associated with a 2.2-fold greater odds (P = .01) of high-sensitivity cardiac troponin-T levels equal to or exceeding 14 ng per mL during the same visit – indicating prevalent myocardial damage – even after controlling for race, sex, body mass index, smoking and alcohol use, triglyceride and cholesterol levels, diabetes, glomerular filtration rate, and use of antihypertensives and lipid-lowering drugs, said the researchers. The odds of myocardial damage remained increased even when DBP was 60 to 69 mm Hg (odds ratio, 1.5; P = .05). Low DBP also was associated with myocardial damage at any given systolic blood pressure.
Furthermore, low DBP significantly increased the risk of progressively worsening myocardial damage, as indicated by a rising annual change in high-sensitivity cardiac troponin-T levels over 6 years. The association was significant as long as DBP was under 80 mm Hg, but was strongest when DBP was less than 60 mm Hg. Diastolic blood pressure under 60 mm Hg also significantly increased the chances of incident CHD and death, but not stroke.
Low DBP was most strongly linked to subclinical myocardial damage and incident CHD when systolic blood pressure was at least 120 mm Hg, indicating elevated pulse pressure, the researchers reported. Systolic pressure is “the main determinant of cardiac afterload and, thus, a primary driver of myocardial energy requirements,” while low DBP reduces myocardial energy supply, they noted. Therefore, high pulse pressure would lead to the greatest mismatch between myocardial energy demand and supply.
“Among patients being treated to SBP goals of 140 mm Hg or lower, attention may need to be paid not only to SBP, but also, importantly, to achieved DBP. Diastolic and systolic BP are inextricably linked, and our results highlighted the importance of not ignoring the former and focusing only on the latter, instead emphasizing the need to consider both in the optimal treatment of adults with hypertension.,”
The study was supported by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases and by the National Heart, Lung, and Blood Institute. Roche Diagnostics provided reagents for the cardiac troponin assays. Dr. McEvoy had no disclosures. One author disclosed ties to Roche; one author disclosed ties to Roche, Abbott Diagnostics, and several other relevant companies; and two authors are coinvestigators on a provisional patent filed by Roche for use of biomarkers in predicting heart failure. The other four authors had no disclosures.
From the Journal of the American College of Cardiology
Key clinical point: Low diastolic blood pressure is associated with myocardial injury and incident coronary heart disease.
Major finding: Diastolic blood pressure below 60 mm Hg more than doubled the odds of high-sensitivity cardiac troponin-T levels equaling or exceeding 14 ng per mL and increased the risk of incident coronary heart disease by about 50%, compared to diastolic blood pressure of 80 to 89 mm Hg. Associations were strongest when pressure was elevated (above 60 mm Hg).
Data source: A prospective observational study of 11,565 adults followed for 21 years as part of the Atherosclerosis Risk in Communities cohort.
Disclosures: The study was supported by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases and by the National Heart, Lung, and Blood Institute. Roche Diagnostics provided reagents for the cardiac troponin assays. Dr. McEvoy had no disclosures. One author disclosed ties to Roche; one author disclosed ties to Roche, Abbott Diagnostics, and several other relevant companies; and two authors are coinvestigators on a provisional patent filed by Roche for use of biomarkers in predicting heart failure. The other four authors had no disclosures.
Access issues looming as more docs eye exit from clinical practice
Almost half (47.8%) of physicians surveyed are considering a change in how they practice medicine within the next 1-3 years, including cutting back on hours, retiring, switching to cash/concierge practice, working locum tenens, seeking a nonclinical health care job, seeking employment, or working part time.
That’s according to responses to the 2016 Survey of America’s Physicians Practice Patterns & Perspectives, a biennial survey commissioned by The Physicians Foundation and conducted by Merritt Hawkins. A total of 17,236 physicians responded to the survey.
The percentage looking to change is up from 43.6% in the 2014 survey, but down from the 50.2% of physicians who responded the same way in 2012.
Dr. Ray pointed to a number of findings in the survey that could be driving the growth in those looking to make a change.
“If you think about the last year, the clinical, administrative, and financial changes that have occurred have occurred at a whirlwind pace,” Dr. Ray said. “For instance, continued expansion of the Affordable Care Act has included as many as 20 million new people to the rolls at the same time we have a documented physician shortage where 80% of physicians say that they have all the patients that they can take care of. They are either at capacity or they are overextended.”
Other factors influencing physicians’ employment decisions include the transition to value-based payments under the Medicare Access and CHIP Reauthorization Act (MACRA), the transition to ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” he said. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Given the volume of change, it is no surprise that physician morale is low, Dr. Ray said. “One of the first things that jumps out is morale. The question was ‘what best describes your professional morale about your current feelings and the current state of the medical profession?’ and 54% were somewhat or very negative; 46% were positive/somewhat positive/very positive. The very negatives were twice what the very positives were,” he noted.
Inadequate time to deliver quality care also was cited.
“Only 14% [of respondents] said that they have all the time that they need to provide the highest standards of care; 86% said that their time was either always limited, often limited, or sometimes limited,” Dr. Ray said.
Dr. Ray highlighted another question that provides insight into physicians’ dissatisfaction with their practice environment.
The survey asked, “To what degree is patient care in your practice adversely impacted by external factors such as third party authorizations, treatment protocols, EHR design, etc.”
“The critical term here is ‘adversely impacted,’ not just influenced, but adversely impacted,” Dr. Ray said. “Only 2.3% said not at all; 10% total said either not at all or a little bit. The rest said either somewhat, a good deal, or a great deal. In fact, 72% said a good deal or a great deal.”
All of this is leading to physician burnout, he said.
“I think it all bounces back to interference with the doctor/patient relationship and the fact that [physicians] feel like there are distractions within the practice of medicine due to the regulatory environment,” he said “They are not allowed to make decisions like they want to make in the best interest of their patients based on their training and their studying and their special experience with that patient. It creates this barrier with this professional satisfaction that they want to receive from taking care of patients.”
Almost half (47.8%) of physicians surveyed are considering a change in how they practice medicine within the next 1-3 years, including cutting back on hours, retiring, switching to cash/concierge practice, working locum tenens, seeking a nonclinical health care job, seeking employment, or working part time.
That’s according to responses to the 2016 Survey of America’s Physicians Practice Patterns & Perspectives, a biennial survey commissioned by The Physicians Foundation and conducted by Merritt Hawkins. A total of 17,236 physicians responded to the survey.
The percentage looking to change is up from 43.6% in the 2014 survey, but down from the 50.2% of physicians who responded the same way in 2012.
Dr. Ray pointed to a number of findings in the survey that could be driving the growth in those looking to make a change.
“If you think about the last year, the clinical, administrative, and financial changes that have occurred have occurred at a whirlwind pace,” Dr. Ray said. “For instance, continued expansion of the Affordable Care Act has included as many as 20 million new people to the rolls at the same time we have a documented physician shortage where 80% of physicians say that they have all the patients that they can take care of. They are either at capacity or they are overextended.”
Other factors influencing physicians’ employment decisions include the transition to value-based payments under the Medicare Access and CHIP Reauthorization Act (MACRA), the transition to ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” he said. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Given the volume of change, it is no surprise that physician morale is low, Dr. Ray said. “One of the first things that jumps out is morale. The question was ‘what best describes your professional morale about your current feelings and the current state of the medical profession?’ and 54% were somewhat or very negative; 46% were positive/somewhat positive/very positive. The very negatives were twice what the very positives were,” he noted.
Inadequate time to deliver quality care also was cited.
“Only 14% [of respondents] said that they have all the time that they need to provide the highest standards of care; 86% said that their time was either always limited, often limited, or sometimes limited,” Dr. Ray said.
Dr. Ray highlighted another question that provides insight into physicians’ dissatisfaction with their practice environment.
The survey asked, “To what degree is patient care in your practice adversely impacted by external factors such as third party authorizations, treatment protocols, EHR design, etc.”
“The critical term here is ‘adversely impacted,’ not just influenced, but adversely impacted,” Dr. Ray said. “Only 2.3% said not at all; 10% total said either not at all or a little bit. The rest said either somewhat, a good deal, or a great deal. In fact, 72% said a good deal or a great deal.”
All of this is leading to physician burnout, he said.
“I think it all bounces back to interference with the doctor/patient relationship and the fact that [physicians] feel like there are distractions within the practice of medicine due to the regulatory environment,” he said “They are not allowed to make decisions like they want to make in the best interest of their patients based on their training and their studying and their special experience with that patient. It creates this barrier with this professional satisfaction that they want to receive from taking care of patients.”
Almost half (47.8%) of physicians surveyed are considering a change in how they practice medicine within the next 1-3 years, including cutting back on hours, retiring, switching to cash/concierge practice, working locum tenens, seeking a nonclinical health care job, seeking employment, or working part time.
That’s according to responses to the 2016 Survey of America’s Physicians Practice Patterns & Perspectives, a biennial survey commissioned by The Physicians Foundation and conducted by Merritt Hawkins. A total of 17,236 physicians responded to the survey.
The percentage looking to change is up from 43.6% in the 2014 survey, but down from the 50.2% of physicians who responded the same way in 2012.
Dr. Ray pointed to a number of findings in the survey that could be driving the growth in those looking to make a change.
“If you think about the last year, the clinical, administrative, and financial changes that have occurred have occurred at a whirlwind pace,” Dr. Ray said. “For instance, continued expansion of the Affordable Care Act has included as many as 20 million new people to the rolls at the same time we have a documented physician shortage where 80% of physicians say that they have all the patients that they can take care of. They are either at capacity or they are overextended.”
Other factors influencing physicians’ employment decisions include the transition to value-based payments under the Medicare Access and CHIP Reauthorization Act (MACRA), the transition to ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” he said. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Given the volume of change, it is no surprise that physician morale is low, Dr. Ray said. “One of the first things that jumps out is morale. The question was ‘what best describes your professional morale about your current feelings and the current state of the medical profession?’ and 54% were somewhat or very negative; 46% were positive/somewhat positive/very positive. The very negatives were twice what the very positives were,” he noted.
Inadequate time to deliver quality care also was cited.
“Only 14% [of respondents] said that they have all the time that they need to provide the highest standards of care; 86% said that their time was either always limited, often limited, or sometimes limited,” Dr. Ray said.
Dr. Ray highlighted another question that provides insight into physicians’ dissatisfaction with their practice environment.
The survey asked, “To what degree is patient care in your practice adversely impacted by external factors such as third party authorizations, treatment protocols, EHR design, etc.”
“The critical term here is ‘adversely impacted,’ not just influenced, but adversely impacted,” Dr. Ray said. “Only 2.3% said not at all; 10% total said either not at all or a little bit. The rest said either somewhat, a good deal, or a great deal. In fact, 72% said a good deal or a great deal.”
All of this is leading to physician burnout, he said.
“I think it all bounces back to interference with the doctor/patient relationship and the fact that [physicians] feel like there are distractions within the practice of medicine due to the regulatory environment,” he said “They are not allowed to make decisions like they want to make in the best interest of their patients based on their training and their studying and their special experience with that patient. It creates this barrier with this professional satisfaction that they want to receive from taking care of patients.”
FDA approves atezolizumab for advanced NSCLC
The Food and Drug Administration has approved the programmed death-ligand 1 (PD-L1) blocking antibody atezolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed during or following platinum-containing chemotherapy.
The FDA previously approved atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
Approval for treatment of NSCLC was based on results from the phase III OAK and phase II POPLAR trials that enrolled a total of 1,137 patients with NSCLC whose disease had progressed on platinum-containing chemotherapy. In OAK, median overall survival for patients assigned to atezolizumab was 13.8 months, compared with 9.6 months for patients assigned to docetaxel, as recently reported at the European Society for Medical Oncology Congress.
In POPLAR, overall survival was 12.6 months for patients receiving atezolizumab versus 9.7 months for those assigned to docetaxel, as reported at the European Cancer Congress in 2015.
The most common (greater than or equal to 20%) adverse reactions in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation, according to the FDA website. The most common (greater than or equal to 2%) grade 3-4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab have included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
Patients with EGFR or ALK genomic tumor aberrations should not receive atezolizumab before having disease progression on FDA-approved therapy for these aberrations, the FDA said.
Full prescribing information is available on the FDA website.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved the programmed death-ligand 1 (PD-L1) blocking antibody atezolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed during or following platinum-containing chemotherapy.
The FDA previously approved atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
Approval for treatment of NSCLC was based on results from the phase III OAK and phase II POPLAR trials that enrolled a total of 1,137 patients with NSCLC whose disease had progressed on platinum-containing chemotherapy. In OAK, median overall survival for patients assigned to atezolizumab was 13.8 months, compared with 9.6 months for patients assigned to docetaxel, as recently reported at the European Society for Medical Oncology Congress.
In POPLAR, overall survival was 12.6 months for patients receiving atezolizumab versus 9.7 months for those assigned to docetaxel, as reported at the European Cancer Congress in 2015.
The most common (greater than or equal to 20%) adverse reactions in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation, according to the FDA website. The most common (greater than or equal to 2%) grade 3-4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab have included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
Patients with EGFR or ALK genomic tumor aberrations should not receive atezolizumab before having disease progression on FDA-approved therapy for these aberrations, the FDA said.
Full prescribing information is available on the FDA website.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved the programmed death-ligand 1 (PD-L1) blocking antibody atezolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed during or following platinum-containing chemotherapy.
The FDA previously approved atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
Approval for treatment of NSCLC was based on results from the phase III OAK and phase II POPLAR trials that enrolled a total of 1,137 patients with NSCLC whose disease had progressed on platinum-containing chemotherapy. In OAK, median overall survival for patients assigned to atezolizumab was 13.8 months, compared with 9.6 months for patients assigned to docetaxel, as recently reported at the European Society for Medical Oncology Congress.
In POPLAR, overall survival was 12.6 months for patients receiving atezolizumab versus 9.7 months for those assigned to docetaxel, as reported at the European Cancer Congress in 2015.
The most common (greater than or equal to 20%) adverse reactions in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation, according to the FDA website. The most common (greater than or equal to 2%) grade 3-4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab have included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
Patients with EGFR or ALK genomic tumor aberrations should not receive atezolizumab before having disease progression on FDA-approved therapy for these aberrations, the FDA said.
Full prescribing information is available on the FDA website.
[email protected]
On Twitter @nikolaideslaura