Video

NEW ORLEANS – The cardiovascular safety profile of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, a selective inhibitor of COX-2, is no worse than those of the nonselective NSAIDs naproxen and ibuprofen, according to a trial reported at the American Heart Association scientific sessions.

The trial, known as PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen) was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that 2%-3% of patients experienced a cardiovascular event (cardiovascular death, myocardial infarction, or stroke) during a follow-up approaching 3 years, regardless of which drug they were assigned to take, with the slight differences falling within predefined margins for noninferiority of celecoxib, investigators reported in a session and related press conference.

Additionally, celecoxib yielded a lower rate of gastrointestinal events when compared with each of the other drugs and a lower rate of renal events when compared with ibuprofen.

“After the withdrawal of rofecoxib, everybody thought they knew the answer, that COX-2 inhibitors had an unfavorable cardiovascular profile,” commented first author Steven E. Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “We didn’t find that. And this is the type of study that once again teaches us that if we jump to conclusions about this based on mechanistic considerations, we often make very bad decisions.”

A cautionary view

“The investigators addressed an extremely important question, which is what is the cardiovascular safety of agents that we administer for a general medical condition over the long term,” commented invited discussant Elliott M. Antman, MD, a senior physician at Brigham and Women’s Hospital and associate dean for Clinical and Translational Research at Harvard Medical School in Boston. “We don’t see a lot of trials like that, but we do need this information.”

Trial details

Patients were eligible for PRECISION, a Pfizer-funded trial, if they had osteoarthritis or rheumatoid arthritis and were at increased cardiovascular risk.

In all, 24,081 patients from 926 centers globally were randomly assigned to double-blind treatment with celecoxib, naproxen, or ibuprofen, all of which are now available as generics in the United States.

“Patients were randomized to the FDA-approved doses of these drugs, and they could have their dose increased if they had unrelieved pain up to the maximum allowed by regulatory authorities in the local jurisdictions where the study was done,” Dr. Nissen noted, pointing out that studies initially generating some concern about celecoxib used a supratherapeutic dose of 800 mg daily.

As COX-2 inhibitors are less likely than nonselective NSAIDs to cause ulcers, which might affect compliance and outcomes, all patients additionally received esomeprazole for gastroprotection “to try to level the playing field,” he explained.

The mean treatment duration was 20.3 months, and the mean follow-up duration was 34.1 months, according to data reported at the meeting and simultaneously published (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593). On average, the daily dose of drug received was 209 mg for celecoxib, 852 mg for naproxen, and 2,045 mg for ibuprofen.

In intention-to-treat analyses, the rate of the primary composite outcome of cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke was 2.3% in the celecoxib group, 2.5% in the naproxen group, and 2.7% in the ibuprofen group. The hazard ratio was 0.93 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.85 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Differences were more marked in the on-treatment population. Here, the rate of the primary outcome was 1.7% in the celecoxib group, 1.8% in the naproxen group, and 1.9% in the ibuprofen group. The HR was 0.90 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.81 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Secondary outcomes, which tested for superiority, showed that the rate of major adverse cardiovascular events was 15% higher in the ibuprofen group as compared with the celecoxib group in the intent-to-treat population. The difference translated to a near-significant reduction in risk with the latter (HR, 0.87; P = .06) that appeared greater in the on-treatment population.

However, Dr. Nissen cautioned that he could not state that celecoxib was superior. “Secondary and tertiary endpoints in a clinical trial are hypothesis generating, and they are not considered definitive evidence,” he commented. At the same time, “the FDA is going to have to deal with that because what do they do with labeling? What do they do with over-the-counter access to these various drugs?”

The rate of all-cause mortality was 25% higher with naproxen than with celecoxib (HR, 0.80; P = .052).

The rate of gastrointestinal events was 54% higher with ibuprofen (HR, 0.65; P = .002) and 41% higher with naproxen (HR, 0.71; P = .01) as compared with celecoxib. And the rate of renal events was 64% higher with ibuprofen than with celecoxib (HR, 0.61; P = .004).

In a post hoc analysis of global safety, the rate of serious cardiovascular, gastrointestinal, and renal events was 28% higher with ibuprofen (HR, 0.78; P less than .001) and 15% higher with naproxen (HR, 0.87; P = .03) than with celecoxib.

Of note, the findings for the primary endpoint were similar regardless of whether patients were taking low-dose aspirin or not. “There was no interaction with aspirin use,” Dr. Nissen stated. “This was not about the interference of ibuprofen or naproxen with aspirin use.”

Analyses of pain relief using a visual analogue scale showed no clinically meaningful differences, suggesting that the drug doses used were equally analgesic, he said. Stopping of study drug because of lack of efficacy was slightly more common in the celecoxib group.

“We didn’t study the low-dose, intermittent use of these drugs that most of the public engages in, and it’s really important that we crisply communicate that to the public because somebody who takes occasionally ibuprofen or naproxen for a headache should not look at these comparative data in a way that should necessarily influence their behavior. We just don’t know the answer,” cautioned Dr. Nissen, who disclosed that he received grant support from Pfizer during the conduct of the trial.

But the findings are relevant for individuals who take over-the-counter NSAIDs at doses exceeding the label, a phenomenon known as dose creep. “We need to reemphasize to the public that the labeled over-the-counter dose is what you should take. You shouldn’t double up or triple up on the drugs because the issue of high-dose therapy, which is what we studied, suggests that there are really potentially important gastrointestinal, renal, and cardiovascular risks,” he said.

NEW ORLEANS – The cardiovascular safety profile of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, a selective inhibitor of COX-2, is no worse than those of the nonselective NSAIDs naproxen and ibuprofen, according to a trial reported at the American Heart Association scientific sessions.

The trial, known as PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen) was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that 2%-3% of patients experienced a cardiovascular event (cardiovascular death, myocardial infarction, or stroke) during a follow-up approaching 3 years, regardless of which drug they were assigned to take, with the slight differences falling within predefined margins for noninferiority of celecoxib, investigators reported in a session and related press conference.

Additionally, celecoxib yielded a lower rate of gastrointestinal events when compared with each of the other drugs and a lower rate of renal events when compared with ibuprofen.

“After the withdrawal of rofecoxib, everybody thought they knew the answer, that COX-2 inhibitors had an unfavorable cardiovascular profile,” commented first author Steven E. Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “We didn’t find that. And this is the type of study that once again teaches us that if we jump to conclusions about this based on mechanistic considerations, we often make very bad decisions.”

A cautionary view

“The investigators addressed an extremely important question, which is what is the cardiovascular safety of agents that we administer for a general medical condition over the long term,” commented invited discussant Elliott M. Antman, MD, a senior physician at Brigham and Women’s Hospital and associate dean for Clinical and Translational Research at Harvard Medical School in Boston. “We don’t see a lot of trials like that, but we do need this information.”

Trial details

Patients were eligible for PRECISION, a Pfizer-funded trial, if they had osteoarthritis or rheumatoid arthritis and were at increased cardiovascular risk.

In all, 24,081 patients from 926 centers globally were randomly assigned to double-blind treatment with celecoxib, naproxen, or ibuprofen, all of which are now available as generics in the United States.

“Patients were randomized to the FDA-approved doses of these drugs, and they could have their dose increased if they had unrelieved pain up to the maximum allowed by regulatory authorities in the local jurisdictions where the study was done,” Dr. Nissen noted, pointing out that studies initially generating some concern about celecoxib used a supratherapeutic dose of 800 mg daily.

As COX-2 inhibitors are less likely than nonselective NSAIDs to cause ulcers, which might affect compliance and outcomes, all patients additionally received esomeprazole for gastroprotection “to try to level the playing field,” he explained.

The mean treatment duration was 20.3 months, and the mean follow-up duration was 34.1 months, according to data reported at the meeting and simultaneously published (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593). On average, the daily dose of drug received was 209 mg for celecoxib, 852 mg for naproxen, and 2,045 mg for ibuprofen.

In intention-to-treat analyses, the rate of the primary composite outcome of cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke was 2.3% in the celecoxib group, 2.5% in the naproxen group, and 2.7% in the ibuprofen group. The hazard ratio was 0.93 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.85 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Differences were more marked in the on-treatment population. Here, the rate of the primary outcome was 1.7% in the celecoxib group, 1.8% in the naproxen group, and 1.9% in the ibuprofen group. The HR was 0.90 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.81 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Secondary outcomes, which tested for superiority, showed that the rate of major adverse cardiovascular events was 15% higher in the ibuprofen group as compared with the celecoxib group in the intent-to-treat population. The difference translated to a near-significant reduction in risk with the latter (HR, 0.87; P = .06) that appeared greater in the on-treatment population.

However, Dr. Nissen cautioned that he could not state that celecoxib was superior. “Secondary and tertiary endpoints in a clinical trial are hypothesis generating, and they are not considered definitive evidence,” he commented. At the same time, “the FDA is going to have to deal with that because what do they do with labeling? What do they do with over-the-counter access to these various drugs?”

The rate of all-cause mortality was 25% higher with naproxen than with celecoxib (HR, 0.80; P = .052).

The rate of gastrointestinal events was 54% higher with ibuprofen (HR, 0.65; P = .002) and 41% higher with naproxen (HR, 0.71; P = .01) as compared with celecoxib. And the rate of renal events was 64% higher with ibuprofen than with celecoxib (HR, 0.61; P = .004).

In a post hoc analysis of global safety, the rate of serious cardiovascular, gastrointestinal, and renal events was 28% higher with ibuprofen (HR, 0.78; P less than .001) and 15% higher with naproxen (HR, 0.87; P = .03) than with celecoxib.

Of note, the findings for the primary endpoint were similar regardless of whether patients were taking low-dose aspirin or not. “There was no interaction with aspirin use,” Dr. Nissen stated. “This was not about the interference of ibuprofen or naproxen with aspirin use.”

Analyses of pain relief using a visual analogue scale showed no clinically meaningful differences, suggesting that the drug doses used were equally analgesic, he said. Stopping of study drug because of lack of efficacy was slightly more common in the celecoxib group.

“We didn’t study the low-dose, intermittent use of these drugs that most of the public engages in, and it’s really important that we crisply communicate that to the public because somebody who takes occasionally ibuprofen or naproxen for a headache should not look at these comparative data in a way that should necessarily influence their behavior. We just don’t know the answer,” cautioned Dr. Nissen, who disclosed that he received grant support from Pfizer during the conduct of the trial.

But the findings are relevant for individuals who take over-the-counter NSAIDs at doses exceeding the label, a phenomenon known as dose creep. “We need to reemphasize to the public that the labeled over-the-counter dose is what you should take. You shouldn’t double up or triple up on the drugs because the issue of high-dose therapy, which is what we studied, suggests that there are really potentially important gastrointestinal, renal, and cardiovascular risks,” he said.

NEW ORLEANS – The cardiovascular safety profile of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, a selective inhibitor of COX-2, is no worse than those of the nonselective NSAIDs naproxen and ibuprofen, according to a trial reported at the American Heart Association scientific sessions.

The trial, known as PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen) was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that 2%-3% of patients experienced a cardiovascular event (cardiovascular death, myocardial infarction, or stroke) during a follow-up approaching 3 years, regardless of which drug they were assigned to take, with the slight differences falling within predefined margins for noninferiority of celecoxib, investigators reported in a session and related press conference.

Additionally, celecoxib yielded a lower rate of gastrointestinal events when compared with each of the other drugs and a lower rate of renal events when compared with ibuprofen.

“After the withdrawal of rofecoxib, everybody thought they knew the answer, that COX-2 inhibitors had an unfavorable cardiovascular profile,” commented first author Steven E. Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “We didn’t find that. And this is the type of study that once again teaches us that if we jump to conclusions about this based on mechanistic considerations, we often make very bad decisions.”

A cautionary view

“The investigators addressed an extremely important question, which is what is the cardiovascular safety of agents that we administer for a general medical condition over the long term,” commented invited discussant Elliott M. Antman, MD, a senior physician at Brigham and Women’s Hospital and associate dean for Clinical and Translational Research at Harvard Medical School in Boston. “We don’t see a lot of trials like that, but we do need this information.”

Trial details

Patients were eligible for PRECISION, a Pfizer-funded trial, if they had osteoarthritis or rheumatoid arthritis and were at increased cardiovascular risk.

In all, 24,081 patients from 926 centers globally were randomly assigned to double-blind treatment with celecoxib, naproxen, or ibuprofen, all of which are now available as generics in the United States.

“Patients were randomized to the FDA-approved doses of these drugs, and they could have their dose increased if they had unrelieved pain up to the maximum allowed by regulatory authorities in the local jurisdictions where the study was done,” Dr. Nissen noted, pointing out that studies initially generating some concern about celecoxib used a supratherapeutic dose of 800 mg daily.

As COX-2 inhibitors are less likely than nonselective NSAIDs to cause ulcers, which might affect compliance and outcomes, all patients additionally received esomeprazole for gastroprotection “to try to level the playing field,” he explained.

The mean treatment duration was 20.3 months, and the mean follow-up duration was 34.1 months, according to data reported at the meeting and simultaneously published (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593). On average, the daily dose of drug received was 209 mg for celecoxib, 852 mg for naproxen, and 2,045 mg for ibuprofen.

In intention-to-treat analyses, the rate of the primary composite outcome of cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke was 2.3% in the celecoxib group, 2.5% in the naproxen group, and 2.7% in the ibuprofen group. The hazard ratio was 0.93 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.85 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Differences were more marked in the on-treatment population. Here, the rate of the primary outcome was 1.7% in the celecoxib group, 1.8% in the naproxen group, and 1.9% in the ibuprofen group. The HR was 0.90 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.81 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Secondary outcomes, which tested for superiority, showed that the rate of major adverse cardiovascular events was 15% higher in the ibuprofen group as compared with the celecoxib group in the intent-to-treat population. The difference translated to a near-significant reduction in risk with the latter (HR, 0.87; P = .06) that appeared greater in the on-treatment population.

However, Dr. Nissen cautioned that he could not state that celecoxib was superior. “Secondary and tertiary endpoints in a clinical trial are hypothesis generating, and they are not considered definitive evidence,” he commented. At the same time, “the FDA is going to have to deal with that because what do they do with labeling? What do they do with over-the-counter access to these various drugs?”

The rate of all-cause mortality was 25% higher with naproxen than with celecoxib (HR, 0.80; P = .052).

The rate of gastrointestinal events was 54% higher with ibuprofen (HR, 0.65; P = .002) and 41% higher with naproxen (HR, 0.71; P = .01) as compared with celecoxib. And the rate of renal events was 64% higher with ibuprofen than with celecoxib (HR, 0.61; P = .004).

In a post hoc analysis of global safety, the rate of serious cardiovascular, gastrointestinal, and renal events was 28% higher with ibuprofen (HR, 0.78; P less than .001) and 15% higher with naproxen (HR, 0.87; P = .03) than with celecoxib.

Of note, the findings for the primary endpoint were similar regardless of whether patients were taking low-dose aspirin or not. “There was no interaction with aspirin use,” Dr. Nissen stated. “This was not about the interference of ibuprofen or naproxen with aspirin use.”

Analyses of pain relief using a visual analogue scale showed no clinically meaningful differences, suggesting that the drug doses used were equally analgesic, he said. Stopping of study drug because of lack of efficacy was slightly more common in the celecoxib group.

“We didn’t study the low-dose, intermittent use of these drugs that most of the public engages in, and it’s really important that we crisply communicate that to the public because somebody who takes occasionally ibuprofen or naproxen for a headache should not look at these comparative data in a way that should necessarily influence their behavior. We just don’t know the answer,” cautioned Dr. Nissen, who disclosed that he received grant support from Pfizer during the conduct of the trial.

But the findings are relevant for individuals who take over-the-counter NSAIDs at doses exceeding the label, a phenomenon known as dose creep. “We need to reemphasize to the public that the labeled over-the-counter dose is what you should take. You shouldn’t double up or triple up on the drugs because the issue of high-dose therapy, which is what we studied, suggests that there are really potentially important gastrointestinal, renal, and cardiovascular risks,” he said.

WASHINGTON – Chronic cardiac inflammation is present in rheumatoid arthritis patients and appears to resolve when they achieve a good clinical response to medical therapy.

The findings of two cardiac imaging studies offer a tantalizing clue to the link between RA and heart failure, said Isabelle Amigues, MD, who reported the findings at the annual meeting of the American College of Rheumatology.

“We know that the inflammation of RA is not just restricted to joints,” said Dr. Amigues, a rheumatology fellow at Columbia University, New York. “We see it throughout the body, so of course it makes sense that we would see it in the heart as well. And now we see that we may be able to manage this with good disease management.

The study that found improvement of myocarditis with RA therapy was very small – just 8 patients and 12 controls – but the results were surprising and encouraging, Dr. Amigues said.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Chronic cardiac inflammation is present in rheumatoid arthritis patients and appears to resolve when they achieve a good clinical response to medical therapy.

The findings of two cardiac imaging studies offer a tantalizing clue to the link between RA and heart failure, said Isabelle Amigues, MD, who reported the findings at the annual meeting of the American College of Rheumatology.

“We know that the inflammation of RA is not just restricted to joints,” said Dr. Amigues, a rheumatology fellow at Columbia University, New York. “We see it throughout the body, so of course it makes sense that we would see it in the heart as well. And now we see that we may be able to manage this with good disease management.

The study that found improvement of myocarditis with RA therapy was very small – just 8 patients and 12 controls – but the results were surprising and encouraging, Dr. Amigues said.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Chronic cardiac inflammation is present in rheumatoid arthritis patients and appears to resolve when they achieve a good clinical response to medical therapy.

The findings of two cardiac imaging studies offer a tantalizing clue to the link between RA and heart failure, said Isabelle Amigues, MD, who reported the findings at the annual meeting of the American College of Rheumatology.

“We know that the inflammation of RA is not just restricted to joints,” said Dr. Amigues, a rheumatology fellow at Columbia University, New York. “We see it throughout the body, so of course it makes sense that we would see it in the heart as well. And now we see that we may be able to manage this with good disease management.

The study that found improvement of myocarditis with RA therapy was very small – just 8 patients and 12 controls – but the results were surprising and encouraging, Dr. Amigues said.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Urate-lowering therapy (ULT) with allopurinol does not appear to increase the risk of chronic kidney disease in patients with gout who have normal or near-normal kidney function at diagnosis, according to a large retrospective study presented at the annual meeting of the American College of Rheumatology.

The study was based on electronic health records from The Health Improvement Network (THIN), a database that includes patients treated by general practitioners in the United Kingdom.

“It is sad in my practice to see how many gout patients are not treated with ULT because patients fear the side effects of medication or just don’t want to be treated, especially when they are not in flare. Many general practitioners also don’t view gout as a serious condition requiring medication,” said lead author Ana Beatriz Vargas-Santos, PhD, a research fellow at Boston University and a rheumatologist at the State University of Rio de Janeiro in a video interview.

[email protected]

WASHINGTON – Urate-lowering therapy (ULT) with allopurinol does not appear to increase the risk of chronic kidney disease in patients with gout who have normal or near-normal kidney function at diagnosis, according to a large retrospective study presented at the annual meeting of the American College of Rheumatology.

The study was based on electronic health records from The Health Improvement Network (THIN), a database that includes patients treated by general practitioners in the United Kingdom.

“It is sad in my practice to see how many gout patients are not treated with ULT because patients fear the side effects of medication or just don’t want to be treated, especially when they are not in flare. Many general practitioners also don’t view gout as a serious condition requiring medication,” said lead author Ana Beatriz Vargas-Santos, PhD, a research fellow at Boston University and a rheumatologist at the State University of Rio de Janeiro in a video interview.

[email protected]

WASHINGTON – Urate-lowering therapy (ULT) with allopurinol does not appear to increase the risk of chronic kidney disease in patients with gout who have normal or near-normal kidney function at diagnosis, according to a large retrospective study presented at the annual meeting of the American College of Rheumatology.

The study was based on electronic health records from The Health Improvement Network (THIN), a database that includes patients treated by general practitioners in the United Kingdom.

“It is sad in my practice to see how many gout patients are not treated with ULT because patients fear the side effects of medication or just don’t want to be treated, especially when they are not in flare. Many general practitioners also don’t view gout as a serious condition requiring medication,” said lead author Ana Beatriz Vargas-Santos, PhD, a research fellow at Boston University and a rheumatologist at the State University of Rio de Janeiro in a video interview.

[email protected]

NEW ORLEANS – A proportion of patients treated appropriately with antibiotics for Staphylococcus aureus bacteremia can generate a negative blood culture followed by a positive one, a new clinical entity researchers are calling the “skip phenomenon.”

“This pattern is really in cases where people have known Staph. aureus bacteremia; it seems to clear; they’re on appropriate antibiotic therapy; and despite that, we see that the blood cultures come back positive again several days later,” explained Justin A. Fiala, MD, of Mayo Clinic in Rochester, Minn.

In a video interview, Dr. Fiala outlined the findings of the first study to identify and characterize this phenomenon.

Certain patients with S. aureus bacteremia could be at higher risk for skip phenomenon, for example. The nested case-control study identified these higher-risk patients, a population that might warrant more clinical testing.

Dr. Fiala also discussed associations with patient outcomes, as well as the overall prevalence of skip phenomenon in his research, which included more than 900 patients with S. aureus bacteremia treated at Mayo Clinic.

Dr. Fiala had no relevant financial disclosures.

[email protected]

NEW ORLEANS – A proportion of patients treated appropriately with antibiotics for Staphylococcus aureus bacteremia can generate a negative blood culture followed by a positive one, a new clinical entity researchers are calling the “skip phenomenon.”

“This pattern is really in cases where people have known Staph. aureus bacteremia; it seems to clear; they’re on appropriate antibiotic therapy; and despite that, we see that the blood cultures come back positive again several days later,” explained Justin A. Fiala, MD, of Mayo Clinic in Rochester, Minn.

In a video interview, Dr. Fiala outlined the findings of the first study to identify and characterize this phenomenon.

Certain patients with S. aureus bacteremia could be at higher risk for skip phenomenon, for example. The nested case-control study identified these higher-risk patients, a population that might warrant more clinical testing.

Dr. Fiala also discussed associations with patient outcomes, as well as the overall prevalence of skip phenomenon in his research, which included more than 900 patients with S. aureus bacteremia treated at Mayo Clinic.

Dr. Fiala had no relevant financial disclosures.

[email protected]

NEW ORLEANS – A proportion of patients treated appropriately with antibiotics for Staphylococcus aureus bacteremia can generate a negative blood culture followed by a positive one, a new clinical entity researchers are calling the “skip phenomenon.”

“This pattern is really in cases where people have known Staph. aureus bacteremia; it seems to clear; they’re on appropriate antibiotic therapy; and despite that, we see that the blood cultures come back positive again several days later,” explained Justin A. Fiala, MD, of Mayo Clinic in Rochester, Minn.

In a video interview, Dr. Fiala outlined the findings of the first study to identify and characterize this phenomenon.

Certain patients with S. aureus bacteremia could be at higher risk for skip phenomenon, for example. The nested case-control study identified these higher-risk patients, a population that might warrant more clinical testing.

Dr. Fiala also discussed associations with patient outcomes, as well as the overall prevalence of skip phenomenon in his research, which included more than 900 patients with S. aureus bacteremia treated at Mayo Clinic.

Dr. Fiala had no relevant financial disclosures.

[email protected]

NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.

Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.

Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.

The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.

“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”

Dr. McCurdy reported having no disclosures.

[email protected]

NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.

Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.

Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.

The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.

“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”

Dr. McCurdy reported having no disclosures.

[email protected]

NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.

Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.

Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.

The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.

“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”

Dr. McCurdy reported having no disclosures.

[email protected]

WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.

During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.

Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.

“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.

“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”

Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.

The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.

The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.

[email protected] On Twitter @mitchelzoler

WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.

During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.

Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.

“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.

“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”

Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.

The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.

The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.

[email protected] On Twitter @mitchelzoler

WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.

During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.

Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.

“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.

“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”

Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.

The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.

The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.

[email protected] On Twitter @mitchelzoler

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

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

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

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

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

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

LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.

“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.

“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.

“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

LAS VEGAS – At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”

In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.

She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.

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

LAS VEGAS – At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”

In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.

She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.

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

LAS VEGAS – At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”

In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.

She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.

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

LAS VEGAS – New topical treatment options for onychomycosis represent significant improvements over older agents, and may approach the success seen with oral drugs, according to Dr. Theodore Rosen, professor of dermatology, Baylor College of Medicine, Houston.

Efinaconazole and tavaborole both permeate the nail and allow for spreading to the lateral nail folds and hyponychium, Dr. Rosen said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. Moreover, the topical treatments are popular with patients. Even if patients are not 100% clear, they are usually happy if their condition improves enough to wear sandals with confidence, Dr. Rosen added in the interview.

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

Dr. Rosen disclosed being a paid participant on the scientific advisory boards for Anacor and Valeant.

[email protected]

LAS VEGAS – New topical treatment options for onychomycosis represent significant improvements over older agents, and may approach the success seen with oral drugs, according to Dr. Theodore Rosen, professor of dermatology, Baylor College of Medicine, Houston.

Efinaconazole and tavaborole both permeate the nail and allow for spreading to the lateral nail folds and hyponychium, Dr. Rosen said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. Moreover, the topical treatments are popular with patients. Even if patients are not 100% clear, they are usually happy if their condition improves enough to wear sandals with confidence, Dr. Rosen added in the interview.

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

Dr. Rosen disclosed being a paid participant on the scientific advisory boards for Anacor and Valeant.

[email protected]

LAS VEGAS – New topical treatment options for onychomycosis represent significant improvements over older agents, and may approach the success seen with oral drugs, according to Dr. Theodore Rosen, professor of dermatology, Baylor College of Medicine, Houston.

Efinaconazole and tavaborole both permeate the nail and allow for spreading to the lateral nail folds and hyponychium, Dr. Rosen said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. Moreover, the topical treatments are popular with patients. Even if patients are not 100% clear, they are usually happy if their condition improves enough to wear sandals with confidence, Dr. Rosen added in the interview.

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

Dr. Rosen disclosed being a paid participant on the scientific advisory boards for Anacor and Valeant.

[email protected]