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PPI, steroid use raises risk of CDAD recurrence

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PPI, steroid use raises risk of CDAD recurrence

AUSTIN, TEX. – Use of proton pump inhibitors and steroids was independently associated with recurrences of Clostridium difficile–associated diarrhea among patients in an intensive care unit, based on a retrospective chart review reported at the annual meeting of the American College of Chest Physicians.

Recurrences were noted in 268 of 2,019 patients who were admitted to a single intensive care unit during a 6-year period and were initially treated successfully for C. difficile–associated diarrhea (CDAD). In a univariate analysis, recurrence was correlated with use of proton pump inhibitors (PPIs) and steroids, but not with age, male gender, or length of hospital stay. After adjusting for age, sex, length of stay, and treatment used, the relationships between recurrence and PPI and steroid use remained statistically significant (P = .0331 and P = .0305, respectively), Dr. Ala Nijim of Akron (Ohio) General Medical Center.

The study subjects comprised 798 men and 1,221 women with an average age of 68 years and an average hospital length of stay of 10 days. Severe disease was present in 233 patients, and 51 had cancer.

CDAD in this study was defined as at least three episodes of loose stools in less than 24 hours with a positive C. difficile toxin assay. Recurrence was defined as a second positive stool test within 90 days following complete resolution of a previous episode of diarrhea episode and cessation of treatment comprising a 10-day period.

Data suggest that the rate of CDAD recurrence is between 10% and 25% at a cost of between $3.2 and $4.8 billion, Dr. Nijim said.

Glucocorticoids are known risk factors for acquiring CDAD, likely due to their immunosuppressive effects, and PPIs have also been suggested as risk factors for acquiring CDAD, although the findings have been mixed. Likewise, treatment with metronidazole for an initial episode has been linked with treatment failure and recurrence risk. In the current study, one of the largest to date to evaluate factors associated with CDAD recurrence, both PPIs and glucocorticoids were shown to be associated with recurrence risk, but no link was found between metronidazole or any CDAD treatment modality and recurrence, Dr. Nijim said.

Though limited by the single-center, retrospective study design and its inherent information and selection biases, the study includes a large ICU patient sample, and the findings suggest that intensivists should watch carefully for recurrence in patients using PPIs and/or steroids.

Also, clinicians should think carefully before starting patients on PPIs – and perhaps use histamine2 blockers instead – in patients with a history of CDAD, she said.

Dr. Nijim reported having no disclosures.

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AUSTIN, TEX. – Use of proton pump inhibitors and steroids was independently associated with recurrences of Clostridium difficile–associated diarrhea among patients in an intensive care unit, based on a retrospective chart review reported at the annual meeting of the American College of Chest Physicians.

Recurrences were noted in 268 of 2,019 patients who were admitted to a single intensive care unit during a 6-year period and were initially treated successfully for C. difficile–associated diarrhea (CDAD). In a univariate analysis, recurrence was correlated with use of proton pump inhibitors (PPIs) and steroids, but not with age, male gender, or length of hospital stay. After adjusting for age, sex, length of stay, and treatment used, the relationships between recurrence and PPI and steroid use remained statistically significant (P = .0331 and P = .0305, respectively), Dr. Ala Nijim of Akron (Ohio) General Medical Center.

The study subjects comprised 798 men and 1,221 women with an average age of 68 years and an average hospital length of stay of 10 days. Severe disease was present in 233 patients, and 51 had cancer.

CDAD in this study was defined as at least three episodes of loose stools in less than 24 hours with a positive C. difficile toxin assay. Recurrence was defined as a second positive stool test within 90 days following complete resolution of a previous episode of diarrhea episode and cessation of treatment comprising a 10-day period.

Data suggest that the rate of CDAD recurrence is between 10% and 25% at a cost of between $3.2 and $4.8 billion, Dr. Nijim said.

Glucocorticoids are known risk factors for acquiring CDAD, likely due to their immunosuppressive effects, and PPIs have also been suggested as risk factors for acquiring CDAD, although the findings have been mixed. Likewise, treatment with metronidazole for an initial episode has been linked with treatment failure and recurrence risk. In the current study, one of the largest to date to evaluate factors associated with CDAD recurrence, both PPIs and glucocorticoids were shown to be associated with recurrence risk, but no link was found between metronidazole or any CDAD treatment modality and recurrence, Dr. Nijim said.

Though limited by the single-center, retrospective study design and its inherent information and selection biases, the study includes a large ICU patient sample, and the findings suggest that intensivists should watch carefully for recurrence in patients using PPIs and/or steroids.

Also, clinicians should think carefully before starting patients on PPIs – and perhaps use histamine2 blockers instead – in patients with a history of CDAD, she said.

Dr. Nijim reported having no disclosures.

AUSTIN, TEX. – Use of proton pump inhibitors and steroids was independently associated with recurrences of Clostridium difficile–associated diarrhea among patients in an intensive care unit, based on a retrospective chart review reported at the annual meeting of the American College of Chest Physicians.

Recurrences were noted in 268 of 2,019 patients who were admitted to a single intensive care unit during a 6-year period and were initially treated successfully for C. difficile–associated diarrhea (CDAD). In a univariate analysis, recurrence was correlated with use of proton pump inhibitors (PPIs) and steroids, but not with age, male gender, or length of hospital stay. After adjusting for age, sex, length of stay, and treatment used, the relationships between recurrence and PPI and steroid use remained statistically significant (P = .0331 and P = .0305, respectively), Dr. Ala Nijim of Akron (Ohio) General Medical Center.

The study subjects comprised 798 men and 1,221 women with an average age of 68 years and an average hospital length of stay of 10 days. Severe disease was present in 233 patients, and 51 had cancer.

CDAD in this study was defined as at least three episodes of loose stools in less than 24 hours with a positive C. difficile toxin assay. Recurrence was defined as a second positive stool test within 90 days following complete resolution of a previous episode of diarrhea episode and cessation of treatment comprising a 10-day period.

Data suggest that the rate of CDAD recurrence is between 10% and 25% at a cost of between $3.2 and $4.8 billion, Dr. Nijim said.

Glucocorticoids are known risk factors for acquiring CDAD, likely due to their immunosuppressive effects, and PPIs have also been suggested as risk factors for acquiring CDAD, although the findings have been mixed. Likewise, treatment with metronidazole for an initial episode has been linked with treatment failure and recurrence risk. In the current study, one of the largest to date to evaluate factors associated with CDAD recurrence, both PPIs and glucocorticoids were shown to be associated with recurrence risk, but no link was found between metronidazole or any CDAD treatment modality and recurrence, Dr. Nijim said.

Though limited by the single-center, retrospective study design and its inherent information and selection biases, the study includes a large ICU patient sample, and the findings suggest that intensivists should watch carefully for recurrence in patients using PPIs and/or steroids.

Also, clinicians should think carefully before starting patients on PPIs – and perhaps use histamine2 blockers instead – in patients with a history of CDAD, she said.

Dr. Nijim reported having no disclosures.

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PPI, steroid use raises risk of CDAD recurrence
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Key clinical point: PPIs may be inadvisable in patients with a history of CDAD.

Major finding: CDAD recurrence was significantly associated with PPI and steroid use (P = .0331 and P = .0305, respectively).

Data source: A retrospective cohort study of 2,019 ICU patients.

Disclosures: Dr. Nijim reported having no disclosures.

Ultrasound plus transthoracic echocardiography speeds CVC placement

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AUSTIN, TEX. – Ultrasound plus real-time transthoracic echocardiography sped up placements of central venous catheters and rule outs of insertion-related pneumothorax, compared with ultrasound alone in a prospective, randomized, controlled study of 60 patients in the medical intensive care unit of a single center.

Compared to conventional ultrasound placement with x-ray confirmation, ultrasound plus transthoracic echocardiography also reduced the time to approval of the line for use, Dr. Dileep Raman reported at the annual meeting of the American College of Chest Physicians.

Waiting for a chest x-ray adds anywhere from 16 minutes to 2 hours to the approval of line use, according to the literature. Ultrasound is “a cheap bedside tool that can be repeatedly used to reduce the amount of chest x-rays for line placement and insertion” and indeed reduced the need for chest x-ray to confirm central venous catheter (CVC) position – without adding to procedure time, he said.

In the study, ultrasound plus transthoracic echocardiography reduced the use of bedside chest x-rays by 57% in 30 patients, compared with conventional ultrasound placement with x-ray confirmation in 29 patients. The mean time to line use was 25 minutes in the ultrasound plus echo group and 53.6 minutes in the conventional placement group, said Dr. Raman of the Cleveland Clinic.

The mean time to complete the procedure was 24.1 minutes in the intervention group, compared with 27.7 minutes in the x-ray confirmation group, he said. None of the study patients had pneumothoraces.

Study subjects were consecutive patients admitted to an intensive care unit at a tertiary care medical center. Both the intervention and control groups had central venous catheters inserted under ultrasound guidance, but the intervention group underwent real-time transthoracic echocardiography to assist in catheter positioning, as well as chest ultrasonography to exclude a pneumothorax. After this process was completed, the line was immediately cleared for use. If the catheter wasn’t detected in the right atrium, the patient was switched to the control group, which was treated using conventional techniques followed by standard chest x-ray.

The study groups were well matched with respect to age, body mass index, and APACHE III score.

Obtaining a chest x-ray to confirm line placement and to exclude pneumothorax remains the standard of care in most ICUs, but Dr. Raman said he and his colleagues dispute that chest x-ray should remain the standard, as it doesn’t identify the superior vena cava–right atrium junction. Also, in addition to reducing the need for chest x-ray, the ultrasound technique seems to give a better picture of line placement.

Additional studies are needed to look at safety and feasibility, because pneumothorax rates are low, and “60 patients is clearly not enough to see if we dented the pneumothorax rate,” he said.

Dr. Raman reported having no disclosures.

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AUSTIN, TEX. – Ultrasound plus real-time transthoracic echocardiography sped up placements of central venous catheters and rule outs of insertion-related pneumothorax, compared with ultrasound alone in a prospective, randomized, controlled study of 60 patients in the medical intensive care unit of a single center.

Compared to conventional ultrasound placement with x-ray confirmation, ultrasound plus transthoracic echocardiography also reduced the time to approval of the line for use, Dr. Dileep Raman reported at the annual meeting of the American College of Chest Physicians.

Waiting for a chest x-ray adds anywhere from 16 minutes to 2 hours to the approval of line use, according to the literature. Ultrasound is “a cheap bedside tool that can be repeatedly used to reduce the amount of chest x-rays for line placement and insertion” and indeed reduced the need for chest x-ray to confirm central venous catheter (CVC) position – without adding to procedure time, he said.

In the study, ultrasound plus transthoracic echocardiography reduced the use of bedside chest x-rays by 57% in 30 patients, compared with conventional ultrasound placement with x-ray confirmation in 29 patients. The mean time to line use was 25 minutes in the ultrasound plus echo group and 53.6 minutes in the conventional placement group, said Dr. Raman of the Cleveland Clinic.

The mean time to complete the procedure was 24.1 minutes in the intervention group, compared with 27.7 minutes in the x-ray confirmation group, he said. None of the study patients had pneumothoraces.

Study subjects were consecutive patients admitted to an intensive care unit at a tertiary care medical center. Both the intervention and control groups had central venous catheters inserted under ultrasound guidance, but the intervention group underwent real-time transthoracic echocardiography to assist in catheter positioning, as well as chest ultrasonography to exclude a pneumothorax. After this process was completed, the line was immediately cleared for use. If the catheter wasn’t detected in the right atrium, the patient was switched to the control group, which was treated using conventional techniques followed by standard chest x-ray.

The study groups were well matched with respect to age, body mass index, and APACHE III score.

Obtaining a chest x-ray to confirm line placement and to exclude pneumothorax remains the standard of care in most ICUs, but Dr. Raman said he and his colleagues dispute that chest x-ray should remain the standard, as it doesn’t identify the superior vena cava–right atrium junction. Also, in addition to reducing the need for chest x-ray, the ultrasound technique seems to give a better picture of line placement.

Additional studies are needed to look at safety and feasibility, because pneumothorax rates are low, and “60 patients is clearly not enough to see if we dented the pneumothorax rate,” he said.

Dr. Raman reported having no disclosures.

AUSTIN, TEX. – Ultrasound plus real-time transthoracic echocardiography sped up placements of central venous catheters and rule outs of insertion-related pneumothorax, compared with ultrasound alone in a prospective, randomized, controlled study of 60 patients in the medical intensive care unit of a single center.

Compared to conventional ultrasound placement with x-ray confirmation, ultrasound plus transthoracic echocardiography also reduced the time to approval of the line for use, Dr. Dileep Raman reported at the annual meeting of the American College of Chest Physicians.

Waiting for a chest x-ray adds anywhere from 16 minutes to 2 hours to the approval of line use, according to the literature. Ultrasound is “a cheap bedside tool that can be repeatedly used to reduce the amount of chest x-rays for line placement and insertion” and indeed reduced the need for chest x-ray to confirm central venous catheter (CVC) position – without adding to procedure time, he said.

In the study, ultrasound plus transthoracic echocardiography reduced the use of bedside chest x-rays by 57% in 30 patients, compared with conventional ultrasound placement with x-ray confirmation in 29 patients. The mean time to line use was 25 minutes in the ultrasound plus echo group and 53.6 minutes in the conventional placement group, said Dr. Raman of the Cleveland Clinic.

The mean time to complete the procedure was 24.1 minutes in the intervention group, compared with 27.7 minutes in the x-ray confirmation group, he said. None of the study patients had pneumothoraces.

Study subjects were consecutive patients admitted to an intensive care unit at a tertiary care medical center. Both the intervention and control groups had central venous catheters inserted under ultrasound guidance, but the intervention group underwent real-time transthoracic echocardiography to assist in catheter positioning, as well as chest ultrasonography to exclude a pneumothorax. After this process was completed, the line was immediately cleared for use. If the catheter wasn’t detected in the right atrium, the patient was switched to the control group, which was treated using conventional techniques followed by standard chest x-ray.

The study groups were well matched with respect to age, body mass index, and APACHE III score.

Obtaining a chest x-ray to confirm line placement and to exclude pneumothorax remains the standard of care in most ICUs, but Dr. Raman said he and his colleagues dispute that chest x-ray should remain the standard, as it doesn’t identify the superior vena cava–right atrium junction. Also, in addition to reducing the need for chest x-ray, the ultrasound technique seems to give a better picture of line placement.

Additional studies are needed to look at safety and feasibility, because pneumothorax rates are low, and “60 patients is clearly not enough to see if we dented the pneumothorax rate,” he said.

Dr. Raman reported having no disclosures.

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Key clinical point: The use of ultrasound and transthoracic echocardiography for CVC placement reduces the need for chest x-ray confirmation.

Major finding: The use of bedside chest x-ray was reduced by 57% with ultrasound plus real-time transthoracic echocardiography.

Data source: A prospective, randomized, controlled study of 60 patients.

Disclosures: Dr. Raman reported having no disclosures.

Extended use of oral anticoagulants reduces VTE recurrence

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AUSTIN, TEX. – Extended treatment with any of the novel oral anticoagulants, but with apixaban in particular, provides a net clinical benefit in patients at risk of recurrent venous thromboembolism, according to a review of three randomized trials.

Apixaban appears to provide the optimal net clinical benefit, with the lowest number needed to treat to avoid one venous thromboembolic or major bleeding event, Dr. Alpesh Amin reported at the annual meeting of the American College of Chest Physicians.

Dr. Alpesh Amin

In 5,035 patients in three trials of extended treatment with novel oral anticoagulants (NOACs) for venous thromboembolism (VTE) – including the RE-SONATE trial, the EINSTEIN-EXT trial, and the AMPLIFY-EXT trial – the differences in event rates, compared with placebo, were –5.15% for dabigatran, –5.74% for rivaroxaban, –7.14% for 2.5 mg apixaban, and –7.0% for 5 mg apixaban, reported Dr. Amin of the University of California, Irvine.

The number needed to treat to avoid one VTE or major bleeding event was 21 for dabigatran, 20 for rivaroxaban, 14 for 2.5 mg apixaban, and 13 for 5 mg apixaban, Dr. Amin said.

“The good news is that the number needed to treat for all of [the oral anticoagulants] is actually less than 25,” he said.

As for costs, the savings from avoiding a recurrent VTE were $2,995 with dabigatran, $3,300 for rivaroxaban, and $4,100 for both 2.5 and 5 mg apixaban.

For major bleeding events, the corresponding rates, compared with placebo, were 0.29%, 0.67%, –0.20%, and –0.36%.

There was a net clinical benefit for all patients treated with the NOACs, but in those treated with 5 mg apixaban, the rates of improvement were highest at –7.44%, followed by –7.38% for 2.5 mg apixaban. The rates were –5.0% with rivaroxaban and –4.85% with dabigatran.

“So we see a low number needed to treat, and a significant amount of cost avoidance by using the NOACs across the board,” he said, adding that apixaban may provide the best net clinical benefit for the lowest number needed to treat to avoid one VTE or major bleeding event, and is associated with the greatest medical cost avoidance.

“In terms of safety endpoints, dabigatran and rivaroxaban cost the system a little bit of money, whereas apixaban actually decreased the cost,” he said.

“How these results translate into real-world outcomes will require further evaluation, and as we get more numbers out there, we will actually be looking at the impact in the real world,” he said.

Dr. Amin reported serving as a paid consultant and/or member of a speakers bureau or advisory committee for Bristol-Myers Squibb and Pfizer.

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AUSTIN, TEX. – Extended treatment with any of the novel oral anticoagulants, but with apixaban in particular, provides a net clinical benefit in patients at risk of recurrent venous thromboembolism, according to a review of three randomized trials.

Apixaban appears to provide the optimal net clinical benefit, with the lowest number needed to treat to avoid one venous thromboembolic or major bleeding event, Dr. Alpesh Amin reported at the annual meeting of the American College of Chest Physicians.

Dr. Alpesh Amin

In 5,035 patients in three trials of extended treatment with novel oral anticoagulants (NOACs) for venous thromboembolism (VTE) – including the RE-SONATE trial, the EINSTEIN-EXT trial, and the AMPLIFY-EXT trial – the differences in event rates, compared with placebo, were –5.15% for dabigatran, –5.74% for rivaroxaban, –7.14% for 2.5 mg apixaban, and –7.0% for 5 mg apixaban, reported Dr. Amin of the University of California, Irvine.

The number needed to treat to avoid one VTE or major bleeding event was 21 for dabigatran, 20 for rivaroxaban, 14 for 2.5 mg apixaban, and 13 for 5 mg apixaban, Dr. Amin said.

“The good news is that the number needed to treat for all of [the oral anticoagulants] is actually less than 25,” he said.

As for costs, the savings from avoiding a recurrent VTE were $2,995 with dabigatran, $3,300 for rivaroxaban, and $4,100 for both 2.5 and 5 mg apixaban.

For major bleeding events, the corresponding rates, compared with placebo, were 0.29%, 0.67%, –0.20%, and –0.36%.

There was a net clinical benefit for all patients treated with the NOACs, but in those treated with 5 mg apixaban, the rates of improvement were highest at –7.44%, followed by –7.38% for 2.5 mg apixaban. The rates were –5.0% with rivaroxaban and –4.85% with dabigatran.

“So we see a low number needed to treat, and a significant amount of cost avoidance by using the NOACs across the board,” he said, adding that apixaban may provide the best net clinical benefit for the lowest number needed to treat to avoid one VTE or major bleeding event, and is associated with the greatest medical cost avoidance.

“In terms of safety endpoints, dabigatran and rivaroxaban cost the system a little bit of money, whereas apixaban actually decreased the cost,” he said.

“How these results translate into real-world outcomes will require further evaluation, and as we get more numbers out there, we will actually be looking at the impact in the real world,” he said.

Dr. Amin reported serving as a paid consultant and/or member of a speakers bureau or advisory committee for Bristol-Myers Squibb and Pfizer.

AUSTIN, TEX. – Extended treatment with any of the novel oral anticoagulants, but with apixaban in particular, provides a net clinical benefit in patients at risk of recurrent venous thromboembolism, according to a review of three randomized trials.

Apixaban appears to provide the optimal net clinical benefit, with the lowest number needed to treat to avoid one venous thromboembolic or major bleeding event, Dr. Alpesh Amin reported at the annual meeting of the American College of Chest Physicians.

Dr. Alpesh Amin

In 5,035 patients in three trials of extended treatment with novel oral anticoagulants (NOACs) for venous thromboembolism (VTE) – including the RE-SONATE trial, the EINSTEIN-EXT trial, and the AMPLIFY-EXT trial – the differences in event rates, compared with placebo, were –5.15% for dabigatran, –5.74% for rivaroxaban, –7.14% for 2.5 mg apixaban, and –7.0% for 5 mg apixaban, reported Dr. Amin of the University of California, Irvine.

The number needed to treat to avoid one VTE or major bleeding event was 21 for dabigatran, 20 for rivaroxaban, 14 for 2.5 mg apixaban, and 13 for 5 mg apixaban, Dr. Amin said.

“The good news is that the number needed to treat for all of [the oral anticoagulants] is actually less than 25,” he said.

As for costs, the savings from avoiding a recurrent VTE were $2,995 with dabigatran, $3,300 for rivaroxaban, and $4,100 for both 2.5 and 5 mg apixaban.

For major bleeding events, the corresponding rates, compared with placebo, were 0.29%, 0.67%, –0.20%, and –0.36%.

There was a net clinical benefit for all patients treated with the NOACs, but in those treated with 5 mg apixaban, the rates of improvement were highest at –7.44%, followed by –7.38% for 2.5 mg apixaban. The rates were –5.0% with rivaroxaban and –4.85% with dabigatran.

“So we see a low number needed to treat, and a significant amount of cost avoidance by using the NOACs across the board,” he said, adding that apixaban may provide the best net clinical benefit for the lowest number needed to treat to avoid one VTE or major bleeding event, and is associated with the greatest medical cost avoidance.

“In terms of safety endpoints, dabigatran and rivaroxaban cost the system a little bit of money, whereas apixaban actually decreased the cost,” he said.

“How these results translate into real-world outcomes will require further evaluation, and as we get more numbers out there, we will actually be looking at the impact in the real world,” he said.

Dr. Amin reported serving as a paid consultant and/or member of a speakers bureau or advisory committee for Bristol-Myers Squibb and Pfizer.

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Key clinical point: All of the NOACs provide a net clinical benefit for reducing VTE recurrence.

Major finding: The number needed to treat to avoid one VTE or major bleeding event was 21 for dabigatran, 20 for rivaroxaban, 14 for 2.5 mg apixaban, and 13 for 5 mg apixaban.

Data source: An analysis of data from three clinical trials, including a total of 5,035 patients.

Disclosures: Dr. Amin reported serving as a paid consultant and/or member of a speakers bureau or advisory committee for Bristol-Myers Squibb and Pfizer.

LABA/ICS betters LABA in moderate and severe COPD

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AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta2-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV1). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV1 percent predicted of at least 50%, and severe disease was defined as FEV1 percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

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AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta2-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV1). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV1 percent predicted of at least 50%, and severe disease was defined as FEV1 percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta2-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV1). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV1 percent predicted of at least 50%, and severe disease was defined as FEV1 percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

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Key clinical point: Combined budesonide/formoterol reduces COPD exacerbations and improves lung function better than formoterol alone.

Major finding: In patients with moderate disease, exacerbation rates per patient-treatment-year without antibiotics were 0.4 in the combination therapy group and 0.7 in the formoterol group.

Data source: A post hoc analysis of pooled data from three trials involving 2,346 patients.

Disclosures: This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

OSA confers survival advantage for ventilated pneumonia patients

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AUSTIN, TEX. – Obstructive sleep apnea appeared to provide protection against in-hospital mortality and nonroutine discharge among mechanically ventilated patients with pneumonia who were included in the National Inpatient Sample from 2009 to 2011.

Patients included in the analysis were 20,652 adults with a mean age of 65 years who were hospitalized with a primary diagnosis of pneumonia requiring invasive mechanical ventilation, representing nearly 107,000 such discharges nationally. About 8% of the patients had obstructive sleep apnea (OSA), and 11% were obese. Overall mortality was 31%, and the overall rate of nonroutine discharge, defined as discharge to a skilled nursing facility or to home with home health care, was 84%, Dr. Charlisa Gibson reported at the annual meeting of the American College of Chest Physicians.

Though limited by its retrospective nature and possible underreporting of OSA, this study demonstrates that OSA in patients with pneumonia requiring invasive mechanical ventilation confers a survival benefit, she said.

Those with OSA had a significantly higher rate of tracheostomy (9.2% vs. 8.3%), a lower rate of in-hospital mortality (19% vs. 31%), and a lower rate of nonroutine discharge (77% vs. 84%), compared with non-OSA patients. Length of stay was about 14 days in both groups, said Dr. Gibson, of Mount Sinai St. Luke’s-Roosevelt Hospital, New York.

Those in the non-OSA group had higher rates of shock and septicemia.

After adjustment for age, sex, obesity, comorbidities, and disease severity, OSA was a significant predictor of decreased in-hospital mortality (odds ratio, 0.74) and nonroutine discharge (odds ratio, 0.73), Dr. Gibson said.

“In pretty much all of the conditions of interest we looked at, we consistently saw that mortality was lower in the OSA group, whether they were obese or not … and whether or not they were deemed to have a low, moderate, or severe [Charlson Comorbidity Index],” she said.

OSA is an important and likely underdiagnosed comorbidity in hospitalized patients, and pneumonia remains a significant infectious cause of morbidity and mortality in hospitalized patients, she said. OSA affects about 5%-24% of the general population, but the percentage of hospitalized patients with OSA is uncertain.

About 20% of hospitalized patients with pneumonia end up in the intensive care unit for supportive treatment with mechanical ventilation.

“Once they are vented, there are data to suggest that early tracheostomy may shorten time on mechanical ventilation and hospital length of stay, but whether or not there’s an actual impact on mortality is controversial,” she said.

While prospective randomized controlled studies are needed to better identify risk factors for mortality, Dr. Gibson said there are several possible explanations for the findings of a protective effect of OSA in hospitalized patients with acute respiratory failure due to pneumonia.

First, non-OSA patients had more septicemia and shock, which suggests they may have had multisystem organ failure and required treatments like renal replacement therapy that independently increased their risk of mortality.

Also, the increased incidence of tracheostomy in the OSA patients may indicate that clinicians were more aggressive in treating patients with OSA, and that those patients may have benefited from earlier tracheostomy, she said.

There is some evidence to suggest that OSA patients have additional coronary collateral circulation, which means that they may have less severe cardiac injury because of this adaptation, and thus may have a lower risk of experiencing a fatal heart attack, compared with non-OSA patients, she explained.

The “obesity paradox” might also work in OSA patients’ favor, she said. There is some evidence that obese patients have increased metabolic reserve that results in lower complication rates, compared with normal weight patients.

“However, we do recommend that regardless of what the reason is, when these patients do come to the unit we should be aggressive and treat them with invasive mechanical ventilation if needed,” she said.

Dr. Gibson reported having no disclosures.

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AUSTIN, TEX. – Obstructive sleep apnea appeared to provide protection against in-hospital mortality and nonroutine discharge among mechanically ventilated patients with pneumonia who were included in the National Inpatient Sample from 2009 to 2011.

Patients included in the analysis were 20,652 adults with a mean age of 65 years who were hospitalized with a primary diagnosis of pneumonia requiring invasive mechanical ventilation, representing nearly 107,000 such discharges nationally. About 8% of the patients had obstructive sleep apnea (OSA), and 11% were obese. Overall mortality was 31%, and the overall rate of nonroutine discharge, defined as discharge to a skilled nursing facility or to home with home health care, was 84%, Dr. Charlisa Gibson reported at the annual meeting of the American College of Chest Physicians.

Though limited by its retrospective nature and possible underreporting of OSA, this study demonstrates that OSA in patients with pneumonia requiring invasive mechanical ventilation confers a survival benefit, she said.

Those with OSA had a significantly higher rate of tracheostomy (9.2% vs. 8.3%), a lower rate of in-hospital mortality (19% vs. 31%), and a lower rate of nonroutine discharge (77% vs. 84%), compared with non-OSA patients. Length of stay was about 14 days in both groups, said Dr. Gibson, of Mount Sinai St. Luke’s-Roosevelt Hospital, New York.

Those in the non-OSA group had higher rates of shock and septicemia.

After adjustment for age, sex, obesity, comorbidities, and disease severity, OSA was a significant predictor of decreased in-hospital mortality (odds ratio, 0.74) and nonroutine discharge (odds ratio, 0.73), Dr. Gibson said.

“In pretty much all of the conditions of interest we looked at, we consistently saw that mortality was lower in the OSA group, whether they were obese or not … and whether or not they were deemed to have a low, moderate, or severe [Charlson Comorbidity Index],” she said.

OSA is an important and likely underdiagnosed comorbidity in hospitalized patients, and pneumonia remains a significant infectious cause of morbidity and mortality in hospitalized patients, she said. OSA affects about 5%-24% of the general population, but the percentage of hospitalized patients with OSA is uncertain.

About 20% of hospitalized patients with pneumonia end up in the intensive care unit for supportive treatment with mechanical ventilation.

“Once they are vented, there are data to suggest that early tracheostomy may shorten time on mechanical ventilation and hospital length of stay, but whether or not there’s an actual impact on mortality is controversial,” she said.

While prospective randomized controlled studies are needed to better identify risk factors for mortality, Dr. Gibson said there are several possible explanations for the findings of a protective effect of OSA in hospitalized patients with acute respiratory failure due to pneumonia.

First, non-OSA patients had more septicemia and shock, which suggests they may have had multisystem organ failure and required treatments like renal replacement therapy that independently increased their risk of mortality.

Also, the increased incidence of tracheostomy in the OSA patients may indicate that clinicians were more aggressive in treating patients with OSA, and that those patients may have benefited from earlier tracheostomy, she said.

There is some evidence to suggest that OSA patients have additional coronary collateral circulation, which means that they may have less severe cardiac injury because of this adaptation, and thus may have a lower risk of experiencing a fatal heart attack, compared with non-OSA patients, she explained.

The “obesity paradox” might also work in OSA patients’ favor, she said. There is some evidence that obese patients have increased metabolic reserve that results in lower complication rates, compared with normal weight patients.

“However, we do recommend that regardless of what the reason is, when these patients do come to the unit we should be aggressive and treat them with invasive mechanical ventilation if needed,” she said.

Dr. Gibson reported having no disclosures.

AUSTIN, TEX. – Obstructive sleep apnea appeared to provide protection against in-hospital mortality and nonroutine discharge among mechanically ventilated patients with pneumonia who were included in the National Inpatient Sample from 2009 to 2011.

Patients included in the analysis were 20,652 adults with a mean age of 65 years who were hospitalized with a primary diagnosis of pneumonia requiring invasive mechanical ventilation, representing nearly 107,000 such discharges nationally. About 8% of the patients had obstructive sleep apnea (OSA), and 11% were obese. Overall mortality was 31%, and the overall rate of nonroutine discharge, defined as discharge to a skilled nursing facility or to home with home health care, was 84%, Dr. Charlisa Gibson reported at the annual meeting of the American College of Chest Physicians.

Though limited by its retrospective nature and possible underreporting of OSA, this study demonstrates that OSA in patients with pneumonia requiring invasive mechanical ventilation confers a survival benefit, she said.

Those with OSA had a significantly higher rate of tracheostomy (9.2% vs. 8.3%), a lower rate of in-hospital mortality (19% vs. 31%), and a lower rate of nonroutine discharge (77% vs. 84%), compared with non-OSA patients. Length of stay was about 14 days in both groups, said Dr. Gibson, of Mount Sinai St. Luke’s-Roosevelt Hospital, New York.

Those in the non-OSA group had higher rates of shock and septicemia.

After adjustment for age, sex, obesity, comorbidities, and disease severity, OSA was a significant predictor of decreased in-hospital mortality (odds ratio, 0.74) and nonroutine discharge (odds ratio, 0.73), Dr. Gibson said.

“In pretty much all of the conditions of interest we looked at, we consistently saw that mortality was lower in the OSA group, whether they were obese or not … and whether or not they were deemed to have a low, moderate, or severe [Charlson Comorbidity Index],” she said.

OSA is an important and likely underdiagnosed comorbidity in hospitalized patients, and pneumonia remains a significant infectious cause of morbidity and mortality in hospitalized patients, she said. OSA affects about 5%-24% of the general population, but the percentage of hospitalized patients with OSA is uncertain.

About 20% of hospitalized patients with pneumonia end up in the intensive care unit for supportive treatment with mechanical ventilation.

“Once they are vented, there are data to suggest that early tracheostomy may shorten time on mechanical ventilation and hospital length of stay, but whether or not there’s an actual impact on mortality is controversial,” she said.

While prospective randomized controlled studies are needed to better identify risk factors for mortality, Dr. Gibson said there are several possible explanations for the findings of a protective effect of OSA in hospitalized patients with acute respiratory failure due to pneumonia.

First, non-OSA patients had more septicemia and shock, which suggests they may have had multisystem organ failure and required treatments like renal replacement therapy that independently increased their risk of mortality.

Also, the increased incidence of tracheostomy in the OSA patients may indicate that clinicians were more aggressive in treating patients with OSA, and that those patients may have benefited from earlier tracheostomy, she said.

There is some evidence to suggest that OSA patients have additional coronary collateral circulation, which means that they may have less severe cardiac injury because of this adaptation, and thus may have a lower risk of experiencing a fatal heart attack, compared with non-OSA patients, she explained.

The “obesity paradox” might also work in OSA patients’ favor, she said. There is some evidence that obese patients have increased metabolic reserve that results in lower complication rates, compared with normal weight patients.

“However, we do recommend that regardless of what the reason is, when these patients do come to the unit we should be aggressive and treat them with invasive mechanical ventilation if needed,” she said.

Dr. Gibson reported having no disclosures.

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Key clinical point: Pneumonia patients with OSA who require mechanical ventilation have a survival advantage, but should still be treated aggressively.

Major finding: OSA was a significant predictor of in-hospital mortality and nonroutine discharge (odds ratios, 0.74 and 0.73).

Data source: A retrospective analysis of data from 20,652 patients in the National Inpatient Sample.

Disclosures: Dr. Gibson reported having no disclosures.

LAMA/LABA provides little benefit over LAMA for early COPD

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AUSTIN, TEX. – Adding a long-acting beta2-agonist to long-acting muscarinic antagonist therapy in patients with low- or moderate-complexity chronic obstructive pulmonary disease appeared to increase costs without providing significant benefit, according to findings from a retrospective cohort study.

The mean all-cause drug-related cost was $5,808 among 274 patients who received LAMA/LABA combination therapy between Jan. 1, 2009, and March 31, 2012, according to the MarketScan database, compared with $7,902 among 1,370 patients receiving LAMA monotherapy, Mona Khalid of Epstein Health, New York, reported at the annual meeting of the American College of Chest Physicians.

After adjustment for observed differences in baseline characteristics, such as disease complexity and comorbidities as assessed by Charlson comorbidity index score, the combination and monotherapy patients had similar all-cause health care resource utilization, with comparable rates of inpatient visits, office visits, and emergency department visits.

“Where we did see some difference was in COPD-related office visits. The patients on combination therapy were twice as likely to have an office visit,” Ms. Khalid said, noting that this difference between groups was statistically significant, and resulted in a mean of $92 more in costs in the combination therapy group.

The overall drug-related costs after adjustment were $1,003 higher in the combination therapy group, she said.

As for treatment adherence, 17% of patients in the combination therapy group had 80% or more days covered with therapy, compared with 25% of those in the monotherapy group. The medication possession ratio was 41% in the combination group, compared with 46% in the monotherapy group (adjusted difference about 5%).

The combination therapy patients included all patients receiving LAMA/LABA therapy identified in the database – which includes commercially insured patients and Medicare patients with supplemental coverage through an employer – during the study period. All were older than 40 years, had medical and pharmacy claims data available for at least 1 year before and after the index date, and had at least one COPD-related claim – but no claims for asthma, nonspecified bronchitis, respiratory cancer, cystic fibrosis, or LABA or LAMA use within the past year. LAMA patients were randomly selected using those same criteria and matched in a 5:1 ratio.

Most of the patients had low-complexity or moderate-complexity disease, although a few patients had severe disease, Ms. Khalid noted.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines call for the use of LAMA monotherapy early in the course of COPD among patients with low to moderate disease complexity. Some patients, however, initiate combination therapy during that phase of disease. The findings support the GOLD monotherapy recommendation in these patients, Ms. Khalid said, although they are limited by factors associated with the retrospective study design and an inability to control well for disease severity because of the use of “claims history as proxy.”

The study was conducted prior to approval of the single-inhaler LABA/LAMA combination therapy, she cautioned, so the results can’t necessarily be extended to that therapy. In addition, because of the use of the MarketScan database, the study findings can’t necessarily be extended to the uninsured population or the Medicaid population, Ms. Khalid noted.

The study was funded by Forest Laboratories. Ms. Khalid’s employer, Epstein Health, received consulting fees from Forest to conduct the study.

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AUSTIN, TEX. – Adding a long-acting beta2-agonist to long-acting muscarinic antagonist therapy in patients with low- or moderate-complexity chronic obstructive pulmonary disease appeared to increase costs without providing significant benefit, according to findings from a retrospective cohort study.

The mean all-cause drug-related cost was $5,808 among 274 patients who received LAMA/LABA combination therapy between Jan. 1, 2009, and March 31, 2012, according to the MarketScan database, compared with $7,902 among 1,370 patients receiving LAMA monotherapy, Mona Khalid of Epstein Health, New York, reported at the annual meeting of the American College of Chest Physicians.

After adjustment for observed differences in baseline characteristics, such as disease complexity and comorbidities as assessed by Charlson comorbidity index score, the combination and monotherapy patients had similar all-cause health care resource utilization, with comparable rates of inpatient visits, office visits, and emergency department visits.

“Where we did see some difference was in COPD-related office visits. The patients on combination therapy were twice as likely to have an office visit,” Ms. Khalid said, noting that this difference between groups was statistically significant, and resulted in a mean of $92 more in costs in the combination therapy group.

The overall drug-related costs after adjustment were $1,003 higher in the combination therapy group, she said.

As for treatment adherence, 17% of patients in the combination therapy group had 80% or more days covered with therapy, compared with 25% of those in the monotherapy group. The medication possession ratio was 41% in the combination group, compared with 46% in the monotherapy group (adjusted difference about 5%).

The combination therapy patients included all patients receiving LAMA/LABA therapy identified in the database – which includes commercially insured patients and Medicare patients with supplemental coverage through an employer – during the study period. All were older than 40 years, had medical and pharmacy claims data available for at least 1 year before and after the index date, and had at least one COPD-related claim – but no claims for asthma, nonspecified bronchitis, respiratory cancer, cystic fibrosis, or LABA or LAMA use within the past year. LAMA patients were randomly selected using those same criteria and matched in a 5:1 ratio.

Most of the patients had low-complexity or moderate-complexity disease, although a few patients had severe disease, Ms. Khalid noted.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines call for the use of LAMA monotherapy early in the course of COPD among patients with low to moderate disease complexity. Some patients, however, initiate combination therapy during that phase of disease. The findings support the GOLD monotherapy recommendation in these patients, Ms. Khalid said, although they are limited by factors associated with the retrospective study design and an inability to control well for disease severity because of the use of “claims history as proxy.”

The study was conducted prior to approval of the single-inhaler LABA/LAMA combination therapy, she cautioned, so the results can’t necessarily be extended to that therapy. In addition, because of the use of the MarketScan database, the study findings can’t necessarily be extended to the uninsured population or the Medicaid population, Ms. Khalid noted.

The study was funded by Forest Laboratories. Ms. Khalid’s employer, Epstein Health, received consulting fees from Forest to conduct the study.

AUSTIN, TEX. – Adding a long-acting beta2-agonist to long-acting muscarinic antagonist therapy in patients with low- or moderate-complexity chronic obstructive pulmonary disease appeared to increase costs without providing significant benefit, according to findings from a retrospective cohort study.

The mean all-cause drug-related cost was $5,808 among 274 patients who received LAMA/LABA combination therapy between Jan. 1, 2009, and March 31, 2012, according to the MarketScan database, compared with $7,902 among 1,370 patients receiving LAMA monotherapy, Mona Khalid of Epstein Health, New York, reported at the annual meeting of the American College of Chest Physicians.

After adjustment for observed differences in baseline characteristics, such as disease complexity and comorbidities as assessed by Charlson comorbidity index score, the combination and monotherapy patients had similar all-cause health care resource utilization, with comparable rates of inpatient visits, office visits, and emergency department visits.

“Where we did see some difference was in COPD-related office visits. The patients on combination therapy were twice as likely to have an office visit,” Ms. Khalid said, noting that this difference between groups was statistically significant, and resulted in a mean of $92 more in costs in the combination therapy group.

The overall drug-related costs after adjustment were $1,003 higher in the combination therapy group, she said.

As for treatment adherence, 17% of patients in the combination therapy group had 80% or more days covered with therapy, compared with 25% of those in the monotherapy group. The medication possession ratio was 41% in the combination group, compared with 46% in the monotherapy group (adjusted difference about 5%).

The combination therapy patients included all patients receiving LAMA/LABA therapy identified in the database – which includes commercially insured patients and Medicare patients with supplemental coverage through an employer – during the study period. All were older than 40 years, had medical and pharmacy claims data available for at least 1 year before and after the index date, and had at least one COPD-related claim – but no claims for asthma, nonspecified bronchitis, respiratory cancer, cystic fibrosis, or LABA or LAMA use within the past year. LAMA patients were randomly selected using those same criteria and matched in a 5:1 ratio.

Most of the patients had low-complexity or moderate-complexity disease, although a few patients had severe disease, Ms. Khalid noted.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines call for the use of LAMA monotherapy early in the course of COPD among patients with low to moderate disease complexity. Some patients, however, initiate combination therapy during that phase of disease. The findings support the GOLD monotherapy recommendation in these patients, Ms. Khalid said, although they are limited by factors associated with the retrospective study design and an inability to control well for disease severity because of the use of “claims history as proxy.”

The study was conducted prior to approval of the single-inhaler LABA/LAMA combination therapy, she cautioned, so the results can’t necessarily be extended to that therapy. In addition, because of the use of the MarketScan database, the study findings can’t necessarily be extended to the uninsured population or the Medicaid population, Ms. Khalid noted.

The study was funded by Forest Laboratories. Ms. Khalid’s employer, Epstein Health, received consulting fees from Forest to conduct the study.

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Key clinical point: LAMA monotherapy appears preferable to LABA/LAMA therapy for low- and moderate-complexity COPD.

Major finding: Overall drug-related costs after adjustment were $1,003 higher in the combination therapy group.

Data source: A retrospective cohort study of 1,644 patients.

Disclosures: The study was funded by Forest Laboratories. Ms. Khalid’s employer, Epstein Health, received consulting fees from Forest to conduct the study.

Primary care screening tool reveals sleep disorders risk

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AUSTIN, TEX. – An online, self-reported tool to determine risk of sleep disorders such as insomnia and restless legs syndrome outperformed assessment by a sleep specialist, new data show.

“Our results suggest that [the online survey] may be used in the primary care setting as a screening method for several sleep disorders,” Dr. Michael Morgenstern, a neurologist at the North Shore Long Island Jewish Medical Center, New Hyde Park, N.Y., said during an original investigation session at the annual meeting of the American College of Chest Physicians.

“The SNORE [Sleep Disorder and Narcolepsy Online Reference for Evaluation] online screening tool performs at least as well as the interviewer in detecting the risk of common sleep disorders, and at times it performs better,” Dr. Morgenstern said.

Dr. Michael Morgenstern

For obstructive sleep apnea and sleep disruption, the online screening tool and sleep physician interview were equal at assessing risk.

In a random, prospective, crossover trial of 53 adult sleep-clinic patients and 24 adult primary care–setting patients, two-thirds of whom were male, the SNORE self-report screening tool demonstrated both high sensitivity and high specificity for determining sleep disorder risks: between 94% and 85%, and 76% and 65%, respectively.

According to the American Academy of Sleep Medicine’s criteria for sleep disorder assessment, sleep specialists accurately determined the risk for insomnia 40.2% of the time, compared with SNORE’s 51.4%.

The online tool also bested a sleep specialist when it came to determining the risk of restless legs syndrome: The tool identified 44.1% of at-risk cases, while the specialist identified 23.3%.

Sleep specialists were slightly better than SNORE at determining patients at risk for sleep apnea: 78% for an interview with a specialist vs. 75.3% using the self-report tool.

Sleep disruption risk was determined equally by either method: 60% by a sleep specialist vs. 60% by SNORE.

Patients in the study were asked to complete the SNORE survey before they were interviewed by a sleep specialist. The sleep specialist was blinded to the patient’s history and survey results. Polysomnography was not included in the assessment, because risk assessment, not diagnosis, was the goal. A third of all participants were randomly assigned to take the SNORE test first or to be interviewed first.

The median overall time necessary to take the entire survey was 6 minutes. If a shortened version was used, the survey took an average of 4 minutes.

Using the survey in the primary care setting could lead to earlier detection and treatment of sleep disorders, Dr. Morgenstern noted, which would aid in overall health.

“For a lot of people who come to a primary care clinic, they don’t think to mention sleep-related symptoms, and the primary care doctor doesn’t really have time to ask about complaints the person isn’t there to talk about,” Dr. Morgenstern said. “But sleep is part of a person’s overall picture of health. Wouldn’t it be great if we had a way to identify issues so patients and providers could talk about it?”

Dr. Morgenstern said he had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

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AUSTIN, TEX. – An online, self-reported tool to determine risk of sleep disorders such as insomnia and restless legs syndrome outperformed assessment by a sleep specialist, new data show.

“Our results suggest that [the online survey] may be used in the primary care setting as a screening method for several sleep disorders,” Dr. Michael Morgenstern, a neurologist at the North Shore Long Island Jewish Medical Center, New Hyde Park, N.Y., said during an original investigation session at the annual meeting of the American College of Chest Physicians.

“The SNORE [Sleep Disorder and Narcolepsy Online Reference for Evaluation] online screening tool performs at least as well as the interviewer in detecting the risk of common sleep disorders, and at times it performs better,” Dr. Morgenstern said.

Dr. Michael Morgenstern

For obstructive sleep apnea and sleep disruption, the online screening tool and sleep physician interview were equal at assessing risk.

In a random, prospective, crossover trial of 53 adult sleep-clinic patients and 24 adult primary care–setting patients, two-thirds of whom were male, the SNORE self-report screening tool demonstrated both high sensitivity and high specificity for determining sleep disorder risks: between 94% and 85%, and 76% and 65%, respectively.

According to the American Academy of Sleep Medicine’s criteria for sleep disorder assessment, sleep specialists accurately determined the risk for insomnia 40.2% of the time, compared with SNORE’s 51.4%.

The online tool also bested a sleep specialist when it came to determining the risk of restless legs syndrome: The tool identified 44.1% of at-risk cases, while the specialist identified 23.3%.

Sleep specialists were slightly better than SNORE at determining patients at risk for sleep apnea: 78% for an interview with a specialist vs. 75.3% using the self-report tool.

Sleep disruption risk was determined equally by either method: 60% by a sleep specialist vs. 60% by SNORE.

Patients in the study were asked to complete the SNORE survey before they were interviewed by a sleep specialist. The sleep specialist was blinded to the patient’s history and survey results. Polysomnography was not included in the assessment, because risk assessment, not diagnosis, was the goal. A third of all participants were randomly assigned to take the SNORE test first or to be interviewed first.

The median overall time necessary to take the entire survey was 6 minutes. If a shortened version was used, the survey took an average of 4 minutes.

Using the survey in the primary care setting could lead to earlier detection and treatment of sleep disorders, Dr. Morgenstern noted, which would aid in overall health.

“For a lot of people who come to a primary care clinic, they don’t think to mention sleep-related symptoms, and the primary care doctor doesn’t really have time to ask about complaints the person isn’t there to talk about,” Dr. Morgenstern said. “But sleep is part of a person’s overall picture of health. Wouldn’t it be great if we had a way to identify issues so patients and providers could talk about it?”

Dr. Morgenstern said he had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – An online, self-reported tool to determine risk of sleep disorders such as insomnia and restless legs syndrome outperformed assessment by a sleep specialist, new data show.

“Our results suggest that [the online survey] may be used in the primary care setting as a screening method for several sleep disorders,” Dr. Michael Morgenstern, a neurologist at the North Shore Long Island Jewish Medical Center, New Hyde Park, N.Y., said during an original investigation session at the annual meeting of the American College of Chest Physicians.

“The SNORE [Sleep Disorder and Narcolepsy Online Reference for Evaluation] online screening tool performs at least as well as the interviewer in detecting the risk of common sleep disorders, and at times it performs better,” Dr. Morgenstern said.

Dr. Michael Morgenstern

For obstructive sleep apnea and sleep disruption, the online screening tool and sleep physician interview were equal at assessing risk.

In a random, prospective, crossover trial of 53 adult sleep-clinic patients and 24 adult primary care–setting patients, two-thirds of whom were male, the SNORE self-report screening tool demonstrated both high sensitivity and high specificity for determining sleep disorder risks: between 94% and 85%, and 76% and 65%, respectively.

According to the American Academy of Sleep Medicine’s criteria for sleep disorder assessment, sleep specialists accurately determined the risk for insomnia 40.2% of the time, compared with SNORE’s 51.4%.

The online tool also bested a sleep specialist when it came to determining the risk of restless legs syndrome: The tool identified 44.1% of at-risk cases, while the specialist identified 23.3%.

Sleep specialists were slightly better than SNORE at determining patients at risk for sleep apnea: 78% for an interview with a specialist vs. 75.3% using the self-report tool.

Sleep disruption risk was determined equally by either method: 60% by a sleep specialist vs. 60% by SNORE.

Patients in the study were asked to complete the SNORE survey before they were interviewed by a sleep specialist. The sleep specialist was blinded to the patient’s history and survey results. Polysomnography was not included in the assessment, because risk assessment, not diagnosis, was the goal. A third of all participants were randomly assigned to take the SNORE test first or to be interviewed first.

The median overall time necessary to take the entire survey was 6 minutes. If a shortened version was used, the survey took an average of 4 minutes.

Using the survey in the primary care setting could lead to earlier detection and treatment of sleep disorders, Dr. Morgenstern noted, which would aid in overall health.

“For a lot of people who come to a primary care clinic, they don’t think to mention sleep-related symptoms, and the primary care doctor doesn’t really have time to ask about complaints the person isn’t there to talk about,” Dr. Morgenstern said. “But sleep is part of a person’s overall picture of health. Wouldn’t it be great if we had a way to identify issues so patients and providers could talk about it?”

Dr. Morgenstern said he had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

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Key clinical point: A self-reported online screening tool may effectively assess a patient’s risk of sleep disorders.

Major finding: The SNORE screening survey performed significantly better than a sleep specialist at identifying risk of insomnia and restless legs syndrome.

Data source: A random, prospective, crossover trial of 53 sleep-clinic patients and 24 primary care–setting patients given the survey and a sleep specialist interview.

Disclosures: Dr. Morgenstern said he had no relevant financial disclosures.

Cigarettes less popular among teens in 2013, but tobacco use remains high

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Although cigarette use among middle and high school students continues to decrease, overall tobacco use is still high, with 22.9% of high school students currently using tobacco products in 2013, the Centers for Disease Control and Prevention reported.

Overall, 46% of high school students reported ever using a tobacco product, and 31.4% reported ever trying two or more tobacco products, according to data from the National Youth Tobacco Survey, published online Nov. 14 (MMWR 2014;63:1021-6).

In 2013, 22.9% of high school students reported current use of a tobacco product; in 2012, 23.3% of high school students reported current tobacco use, and 24.3% used a tobacco product in 2011.

© agmit/istockphoto.com
Overall, 46% of high school students reported ever using a tobacco product.

Combustible tobacco products were the most popular form of tobacco ingestion among current and former users, as 9 out of 10 high school students reporting using them. Cigarettes were the most regularly used tobacco products at 12.7%, followed by cigars (11.9%), smokeless tobacco (5.7%), hookah (5.2%), e-cigarettes (4.5%), and pipes (4.1%).

The study’s authors, led by CDC epidemiologist René A. Arrazola, noted that the data could be influenced by self-reporting bias. The National Youth Tobacco Survey is a school-based, self-administered questionnaire.

Of 250 schools selected for the 2013 National Youth Tobacco Survey, 187 (75%) participated, with a sample of 18,406 (91%) among 20,301 eligible students; the overall response rate was 68%.

The increasing number of teens using e-cigarettes could be cause for concern, because there are few data on the long-term impact of e-cigarette use. However, the 2014 Surgeon General’s report found that adolescent nicotine use can have adverse effects on brain development, whatever the source, the authors noted.

“Considering how trends in tobacco product use and tobacco marketing change, rigorous surveillance of all available forms of tobacco use by youths, particularly use of emerging products such as e-cigarettes, is essential,” they said.

Among middle school students, 17.7% had ever used tobacco. Middle school students were more likely to smoke cigars instead of cigarettes, with 3.1% reporting current use of cigars, and 2.9% reporting current use of cigarettes; 1.1% reported recently using e-cigarettes.

In terms of ethnic demographics, cigarettes were the most prevalent tobacco product used by white and Hispanic high school students (14.0% and 13.4%), although cigars were close behind (11.4% and 12.1%). Overall cigar use among high schoolers decreased but still remains relatively high; it was 11.9% in 2013, compared with 12.6% in 2012.

Cigar use among black high school students was nearly 50% higher than cigarette use (14.7 % vs. 9.0 %), and more than twice as high as cigarette use (4.5% vs 1.7%) among black middle school students.

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Although cigarette use among middle and high school students continues to decrease, overall tobacco use is still high, with 22.9% of high school students currently using tobacco products in 2013, the Centers for Disease Control and Prevention reported.

Overall, 46% of high school students reported ever using a tobacco product, and 31.4% reported ever trying two or more tobacco products, according to data from the National Youth Tobacco Survey, published online Nov. 14 (MMWR 2014;63:1021-6).

In 2013, 22.9% of high school students reported current use of a tobacco product; in 2012, 23.3% of high school students reported current tobacco use, and 24.3% used a tobacco product in 2011.

© agmit/istockphoto.com
Overall, 46% of high school students reported ever using a tobacco product.

Combustible tobacco products were the most popular form of tobacco ingestion among current and former users, as 9 out of 10 high school students reporting using them. Cigarettes were the most regularly used tobacco products at 12.7%, followed by cigars (11.9%), smokeless tobacco (5.7%), hookah (5.2%), e-cigarettes (4.5%), and pipes (4.1%).

The study’s authors, led by CDC epidemiologist René A. Arrazola, noted that the data could be influenced by self-reporting bias. The National Youth Tobacco Survey is a school-based, self-administered questionnaire.

Of 250 schools selected for the 2013 National Youth Tobacco Survey, 187 (75%) participated, with a sample of 18,406 (91%) among 20,301 eligible students; the overall response rate was 68%.

The increasing number of teens using e-cigarettes could be cause for concern, because there are few data on the long-term impact of e-cigarette use. However, the 2014 Surgeon General’s report found that adolescent nicotine use can have adverse effects on brain development, whatever the source, the authors noted.

“Considering how trends in tobacco product use and tobacco marketing change, rigorous surveillance of all available forms of tobacco use by youths, particularly use of emerging products such as e-cigarettes, is essential,” they said.

Among middle school students, 17.7% had ever used tobacco. Middle school students were more likely to smoke cigars instead of cigarettes, with 3.1% reporting current use of cigars, and 2.9% reporting current use of cigarettes; 1.1% reported recently using e-cigarettes.

In terms of ethnic demographics, cigarettes were the most prevalent tobacco product used by white and Hispanic high school students (14.0% and 13.4%), although cigars were close behind (11.4% and 12.1%). Overall cigar use among high schoolers decreased but still remains relatively high; it was 11.9% in 2013, compared with 12.6% in 2012.

Cigar use among black high school students was nearly 50% higher than cigarette use (14.7 % vs. 9.0 %), and more than twice as high as cigarette use (4.5% vs 1.7%) among black middle school students.

[email protected]

Although cigarette use among middle and high school students continues to decrease, overall tobacco use is still high, with 22.9% of high school students currently using tobacco products in 2013, the Centers for Disease Control and Prevention reported.

Overall, 46% of high school students reported ever using a tobacco product, and 31.4% reported ever trying two or more tobacco products, according to data from the National Youth Tobacco Survey, published online Nov. 14 (MMWR 2014;63:1021-6).

In 2013, 22.9% of high school students reported current use of a tobacco product; in 2012, 23.3% of high school students reported current tobacco use, and 24.3% used a tobacco product in 2011.

© agmit/istockphoto.com
Overall, 46% of high school students reported ever using a tobacco product.

Combustible tobacco products were the most popular form of tobacco ingestion among current and former users, as 9 out of 10 high school students reporting using them. Cigarettes were the most regularly used tobacco products at 12.7%, followed by cigars (11.9%), smokeless tobacco (5.7%), hookah (5.2%), e-cigarettes (4.5%), and pipes (4.1%).

The study’s authors, led by CDC epidemiologist René A. Arrazola, noted that the data could be influenced by self-reporting bias. The National Youth Tobacco Survey is a school-based, self-administered questionnaire.

Of 250 schools selected for the 2013 National Youth Tobacco Survey, 187 (75%) participated, with a sample of 18,406 (91%) among 20,301 eligible students; the overall response rate was 68%.

The increasing number of teens using e-cigarettes could be cause for concern, because there are few data on the long-term impact of e-cigarette use. However, the 2014 Surgeon General’s report found that adolescent nicotine use can have adverse effects on brain development, whatever the source, the authors noted.

“Considering how trends in tobacco product use and tobacco marketing change, rigorous surveillance of all available forms of tobacco use by youths, particularly use of emerging products such as e-cigarettes, is essential,” they said.

Among middle school students, 17.7% had ever used tobacco. Middle school students were more likely to smoke cigars instead of cigarettes, with 3.1% reporting current use of cigars, and 2.9% reporting current use of cigarettes; 1.1% reported recently using e-cigarettes.

In terms of ethnic demographics, cigarettes were the most prevalent tobacco product used by white and Hispanic high school students (14.0% and 13.4%), although cigars were close behind (11.4% and 12.1%). Overall cigar use among high schoolers decreased but still remains relatively high; it was 11.9% in 2013, compared with 12.6% in 2012.

Cigar use among black high school students was nearly 50% higher than cigarette use (14.7 % vs. 9.0 %), and more than twice as high as cigarette use (4.5% vs 1.7%) among black middle school students.

[email protected]

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Better thromboprophylaxis didn’t reduce emboli after trauma

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SAN FRANCISCO – Delivering prophylactic therapies against venous thromboembolism sooner and to more patients admitted for trauma failed to reduce the risk of pulmonary embolism in a 6-year study of data on 23,863 patients.

Dr. Matthew J. Pommerening and his associates at the University of Texas, Houston, retrospectively studied data on the management and outcomes of 11,292 adults admitted to their level 1 trauma center in 2006-2008 before implementation of a performance-improvement program, and 12,571 patients admitted in 2009-2011, after the program was in place.

Dr. Matthew J. Pommerening

The performance-improvement program included sequential interventions such as audits for missed doses of thromboprophylactic medications, goals for earlier and more aggressive chemical prophylaxis, and placing prophylactic filters in the inferior vena cava (IVC) in high-risk patients.

Overall, 1% of patients developed a pulmonary embolism. Comparing rates of pulmonary emboli, deaths from pulmonary embolism, or mortality in the preprogram and postprogram time periods, however, showed no significant differences, he said at the annual clinical congress of the American College of Surgeons.

One percent of patients in both time periods developed a pulmonary embolism. The rate of death from pulmonary embolism was 7% in the earlier period and 8% in the later period. Mortality rates were 4.5% in both periods.

That’s despite great improvements in reducing the proportion of patients who got no prophylaxis from 45% in the earlier period to 11% under the improvement program. The use of prophylactic IVC filters increased from 3% in the earlier period to nearly 8% under the program. The time to initiation of prophylaxis decreased from 57 hours to 32 hours, on average.

The proportion of patients who missed a dose of thromboprophylaxis did not change significantly, from 39% in the earlier period to 36% under the program.

“Current prophylactic strategies and therapies for pulmonary embolism may be inadequate,” Dr. Pommerening said, perhaps due to inadequate dosing or inadequate therapies. The utility or potential thrombogenicity of IVC filters is a topic of “serious discussion” at his institution, he said.

“There’s still room for improvement,” he added, by eliminating missed doses and reducing the 11% of patients who got no prophylaxis, he added.

The time to diagnosis of pulmonary embolism and the proportion of emboli located in the main pulmonary artery did not differ significantly by time period.

The size of the study may not have provided enough power to detect differences in rates of emboli between time periods with such a low overall rate of pulmonary emboli to begin with, he said.

The investigators have started to look at whether the performance improvement program made any difference in the rate of deep-vein thrombosis.

Dr. Pommerening reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

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SAN FRANCISCO – Delivering prophylactic therapies against venous thromboembolism sooner and to more patients admitted for trauma failed to reduce the risk of pulmonary embolism in a 6-year study of data on 23,863 patients.

Dr. Matthew J. Pommerening and his associates at the University of Texas, Houston, retrospectively studied data on the management and outcomes of 11,292 adults admitted to their level 1 trauma center in 2006-2008 before implementation of a performance-improvement program, and 12,571 patients admitted in 2009-2011, after the program was in place.

Dr. Matthew J. Pommerening

The performance-improvement program included sequential interventions such as audits for missed doses of thromboprophylactic medications, goals for earlier and more aggressive chemical prophylaxis, and placing prophylactic filters in the inferior vena cava (IVC) in high-risk patients.

Overall, 1% of patients developed a pulmonary embolism. Comparing rates of pulmonary emboli, deaths from pulmonary embolism, or mortality in the preprogram and postprogram time periods, however, showed no significant differences, he said at the annual clinical congress of the American College of Surgeons.

One percent of patients in both time periods developed a pulmonary embolism. The rate of death from pulmonary embolism was 7% in the earlier period and 8% in the later period. Mortality rates were 4.5% in both periods.

That’s despite great improvements in reducing the proportion of patients who got no prophylaxis from 45% in the earlier period to 11% under the improvement program. The use of prophylactic IVC filters increased from 3% in the earlier period to nearly 8% under the program. The time to initiation of prophylaxis decreased from 57 hours to 32 hours, on average.

The proportion of patients who missed a dose of thromboprophylaxis did not change significantly, from 39% in the earlier period to 36% under the program.

“Current prophylactic strategies and therapies for pulmonary embolism may be inadequate,” Dr. Pommerening said, perhaps due to inadequate dosing or inadequate therapies. The utility or potential thrombogenicity of IVC filters is a topic of “serious discussion” at his institution, he said.

“There’s still room for improvement,” he added, by eliminating missed doses and reducing the 11% of patients who got no prophylaxis, he added.

The time to diagnosis of pulmonary embolism and the proportion of emboli located in the main pulmonary artery did not differ significantly by time period.

The size of the study may not have provided enough power to detect differences in rates of emboli between time periods with such a low overall rate of pulmonary emboli to begin with, he said.

The investigators have started to look at whether the performance improvement program made any difference in the rate of deep-vein thrombosis.

Dr. Pommerening reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Delivering prophylactic therapies against venous thromboembolism sooner and to more patients admitted for trauma failed to reduce the risk of pulmonary embolism in a 6-year study of data on 23,863 patients.

Dr. Matthew J. Pommerening and his associates at the University of Texas, Houston, retrospectively studied data on the management and outcomes of 11,292 adults admitted to their level 1 trauma center in 2006-2008 before implementation of a performance-improvement program, and 12,571 patients admitted in 2009-2011, after the program was in place.

Dr. Matthew J. Pommerening

The performance-improvement program included sequential interventions such as audits for missed doses of thromboprophylactic medications, goals for earlier and more aggressive chemical prophylaxis, and placing prophylactic filters in the inferior vena cava (IVC) in high-risk patients.

Overall, 1% of patients developed a pulmonary embolism. Comparing rates of pulmonary emboli, deaths from pulmonary embolism, or mortality in the preprogram and postprogram time periods, however, showed no significant differences, he said at the annual clinical congress of the American College of Surgeons.

One percent of patients in both time periods developed a pulmonary embolism. The rate of death from pulmonary embolism was 7% in the earlier period and 8% in the later period. Mortality rates were 4.5% in both periods.

That’s despite great improvements in reducing the proportion of patients who got no prophylaxis from 45% in the earlier period to 11% under the improvement program. The use of prophylactic IVC filters increased from 3% in the earlier period to nearly 8% under the program. The time to initiation of prophylaxis decreased from 57 hours to 32 hours, on average.

The proportion of patients who missed a dose of thromboprophylaxis did not change significantly, from 39% in the earlier period to 36% under the program.

“Current prophylactic strategies and therapies for pulmonary embolism may be inadequate,” Dr. Pommerening said, perhaps due to inadequate dosing or inadequate therapies. The utility or potential thrombogenicity of IVC filters is a topic of “serious discussion” at his institution, he said.

“There’s still room for improvement,” he added, by eliminating missed doses and reducing the 11% of patients who got no prophylaxis, he added.

The time to diagnosis of pulmonary embolism and the proportion of emboli located in the main pulmonary artery did not differ significantly by time period.

The size of the study may not have provided enough power to detect differences in rates of emboli between time periods with such a low overall rate of pulmonary emboli to begin with, he said.

The investigators have started to look at whether the performance improvement program made any difference in the rate of deep-vein thrombosis.

Dr. Pommerening reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

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Key clinical point: Current thromboprophylaxis strategies may not reduce pulmonary emboli after trauma.

Major finding: Pulmonary embolism occurred in 1% of trauma patients in each time period.

Data source: Retrospective study of 23,863 patients admitted before or after initiation of a thromboprophylaxis improvement program.

Disclosures: Dr. Pommerening reported having no financial disclosures.

Tdap during pregnancy: No link to adverse outcomes

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Receiving the Tdap vaccine during pregnancy did not raise the risk of maternal hypertensive disorders, preterm birth, or small-for-gestational age infants in an observational study of 123,494 California pregnancies, according to a report published online November 11 in JAMA.

In response to recent outbreaks of pertussis, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends that the Tdap vaccine be given to all pregnant women, preferably at 27-36 weeks’ gestation. However, specific data regarding possible adverse effects on mothers or children are “limited,” said Dr. Elyse O. Kharbanda of HealthPartners Institute for Education and Research, Minneapolis, and her associates.

To examine the issue, the investigators analyzed information from the Vaccine Safety Datalink regarding singleton pregnancies resulting in a live birth at two California sites during a 3-year period. A total of 26,229 (21%) of mothers received the Tdap vaccine during pregnancy, and the remaining 97,265 did not, although 46% of them had received Tdap prior to pregnancy.

© AvailableLight / stockphoto.com
A new study shows that receiving the Tdap vaccine during pregnancy does not raise the risk of maternal hypertensive disorders, preterm birth, or small-for-gestational age infants.

The rates of preterm birth were 6.3% in vaccine-exposed pregnancies and 7.8% in nonexposed pregnancies, a nonsignificant difference. Similarly, the rates of SGA infants were nearly identical between the two study groups at 8.4% and 8.3%, respectively. And the rates of maternal hypertensive disorders – including gestational hypertension, hypertension in pregnancy not otherwise specified, preeclampsia, and eclampsia – were not significantly different at 8.2% and 8.0%, respectively, Dr. Kharbanda and her associates said (JAMA 2014 [doi:10.1001/jama.2014.14825]).

“We detected an increased risk of being diagnosed with chorioamnionitis following vaccination,” but that finding should be interpreted with caution because the magnitude of the risk was small, and it didn’t translate into increased risk of preterm delivery. This weak association may have been due to residual confounding, especially since the data could not be adjusted to account for important chorioamnionitis risk factors such as prolonged rupture of membranes, prolonged labor, or the presence of pathogens in the mother’s genital tract, the investigators noted.

This study was funded by the Centers for Disease Control and Prevention. Dr. Kharbanda reported having no financial disclosures; some of her associates reported ties to GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Novartis, Nuron Biotech, Protein Science, and MedImmune. Two associates are CDC employees.

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Receiving the Tdap vaccine during pregnancy did not raise the risk of maternal hypertensive disorders, preterm birth, or small-for-gestational age infants in an observational study of 123,494 California pregnancies, according to a report published online November 11 in JAMA.

In response to recent outbreaks of pertussis, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends that the Tdap vaccine be given to all pregnant women, preferably at 27-36 weeks’ gestation. However, specific data regarding possible adverse effects on mothers or children are “limited,” said Dr. Elyse O. Kharbanda of HealthPartners Institute for Education and Research, Minneapolis, and her associates.

To examine the issue, the investigators analyzed information from the Vaccine Safety Datalink regarding singleton pregnancies resulting in a live birth at two California sites during a 3-year period. A total of 26,229 (21%) of mothers received the Tdap vaccine during pregnancy, and the remaining 97,265 did not, although 46% of them had received Tdap prior to pregnancy.

© AvailableLight / stockphoto.com
A new study shows that receiving the Tdap vaccine during pregnancy does not raise the risk of maternal hypertensive disorders, preterm birth, or small-for-gestational age infants.

The rates of preterm birth were 6.3% in vaccine-exposed pregnancies and 7.8% in nonexposed pregnancies, a nonsignificant difference. Similarly, the rates of SGA infants were nearly identical between the two study groups at 8.4% and 8.3%, respectively. And the rates of maternal hypertensive disorders – including gestational hypertension, hypertension in pregnancy not otherwise specified, preeclampsia, and eclampsia – were not significantly different at 8.2% and 8.0%, respectively, Dr. Kharbanda and her associates said (JAMA 2014 [doi:10.1001/jama.2014.14825]).

“We detected an increased risk of being diagnosed with chorioamnionitis following vaccination,” but that finding should be interpreted with caution because the magnitude of the risk was small, and it didn’t translate into increased risk of preterm delivery. This weak association may have been due to residual confounding, especially since the data could not be adjusted to account for important chorioamnionitis risk factors such as prolonged rupture of membranes, prolonged labor, or the presence of pathogens in the mother’s genital tract, the investigators noted.

This study was funded by the Centers for Disease Control and Prevention. Dr. Kharbanda reported having no financial disclosures; some of her associates reported ties to GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Novartis, Nuron Biotech, Protein Science, and MedImmune. Two associates are CDC employees.

Receiving the Tdap vaccine during pregnancy did not raise the risk of maternal hypertensive disorders, preterm birth, or small-for-gestational age infants in an observational study of 123,494 California pregnancies, according to a report published online November 11 in JAMA.

In response to recent outbreaks of pertussis, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends that the Tdap vaccine be given to all pregnant women, preferably at 27-36 weeks’ gestation. However, specific data regarding possible adverse effects on mothers or children are “limited,” said Dr. Elyse O. Kharbanda of HealthPartners Institute for Education and Research, Minneapolis, and her associates.

To examine the issue, the investigators analyzed information from the Vaccine Safety Datalink regarding singleton pregnancies resulting in a live birth at two California sites during a 3-year period. A total of 26,229 (21%) of mothers received the Tdap vaccine during pregnancy, and the remaining 97,265 did not, although 46% of them had received Tdap prior to pregnancy.

© AvailableLight / stockphoto.com
A new study shows that receiving the Tdap vaccine during pregnancy does not raise the risk of maternal hypertensive disorders, preterm birth, or small-for-gestational age infants.

The rates of preterm birth were 6.3% in vaccine-exposed pregnancies and 7.8% in nonexposed pregnancies, a nonsignificant difference. Similarly, the rates of SGA infants were nearly identical between the two study groups at 8.4% and 8.3%, respectively. And the rates of maternal hypertensive disorders – including gestational hypertension, hypertension in pregnancy not otherwise specified, preeclampsia, and eclampsia – were not significantly different at 8.2% and 8.0%, respectively, Dr. Kharbanda and her associates said (JAMA 2014 [doi:10.1001/jama.2014.14825]).

“We detected an increased risk of being diagnosed with chorioamnionitis following vaccination,” but that finding should be interpreted with caution because the magnitude of the risk was small, and it didn’t translate into increased risk of preterm delivery. This weak association may have been due to residual confounding, especially since the data could not be adjusted to account for important chorioamnionitis risk factors such as prolonged rupture of membranes, prolonged labor, or the presence of pathogens in the mother’s genital tract, the investigators noted.

This study was funded by the Centers for Disease Control and Prevention. Dr. Kharbanda reported having no financial disclosures; some of her associates reported ties to GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Novartis, Nuron Biotech, Protein Science, and MedImmune. Two associates are CDC employees.

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Key clinical point: Receipt of the pertussis vaccine during pregnancy was not associated with preterm birth, SGA birth, or hypertensive disorders of pregnancy.

Major finding: Rates of preterm birth were 6.3% in vaccine-exposed pregnancies and 7.8% in nonexposed pregnancies, rates of SGA infants were 8.4% and 8.3%, respectively, and rates of maternal hypertensive disorders were 8.2% and 8.0.

Data source: A retrospective observational cohort study involving 123,494 singleton pregnancies in California, including 26,229 (21%) in which the mother received the Tdap vaccine.

Disclosures: This study was funded by the Centers for Disease Control and Prevention. Dr. Kharbanda reported having no financial disclosures; some of her associates reported ties to GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Novartis, Nuron Biotech, Protein Science, and MedImmune. Two associates are CDC employees.