Pulmonary Health Hub

PARIS – Autologous stem-cell transplantation has emerged as an effective and feasible treatment for selected patients with severe systemic sclerosis who inadequately respond to conventional treatments, said two U.S. experts.

In addition, convincing evidence documenting the overall beneficial effect of autologous stem-cell transplantation will soon appear in a published report from the Autologous Stem Cell Transplantation International Scleroderma (ASTIS) trial, Dr. Dinesh Khanna said in a talk at the annual European Congress of Rheumatology.

In his talk, Dr. Khanna gave a short preview of the ASTIS results that he said would appear in a medical journal in the next few weeks. Those results show that among 79 scleroderma patients randomized to treatment with autologous stem-cell transplant, 8 (10%) died from treatment-related causes, compared with none in the control arm of patients who received conventional treatment with cyclophosphamide. But during follow-up, a total of 16 of the 79 (20%) stem-cell transplant patients died, compared with 24 of the 77 (31%) control patients, results that showed an overall mortality benefit from stem-cell transplantation.

The transplanted patients also showed "large improvements" in their skin score and "substantial improvements" in their forced vital capacity and in their activity as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), noted Dr. Khanna, director of the scleroderma program at the University of Michigan in Ann Arbor.

"Before and after treatment, patients look completely different. Some patients [treated with stem-cell transplants] you can’t tell that they had scleroderma. But you need to select the right patients," he cautioned. "There is high mortality early, but if you select patients correctly the benefits will outweigh the risks. This is what we now offer to patients" who don’t respond to conventional treatments and are suitable for transplantation, Dr. Khanna said.

Researchers had previously reported these ASTIS results during the EULAR 2012 meeting.

Stem-cell treatment is appropriate for "the 10%-15% of patients with scleroderma who are the worst," commented Dr. Daniel Furst, a professor in rheumatology at the University of California, Los Angeles. "The next step is to move this treatment from the worst patients to those who are less severe. In some centers in Europe, stem-cell transplantation is becoming widely used, even for patients with only skin symptoms," Dr. Furst said in an interview.

A major attraction of stem-cell transplantation is that over time it produces regression of fibrosis and collagen deposits and healing of prior organ damage. But the treatment also carries the risk of causing substantial immunosuppression while the immune system repopulates, leaving patients vulnerable to infections and other complications.

The upcoming publication of the ASTIS findings should further cement the role of stem-cell transplantation in scleroderma management, but "I’m more of a skeptic. I would like to see it reproduced" in a second trial, Dr. Furst said. Specifically, he means the North American–based Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial now in progress. A positive result in SCOT is still needed to convince many insurers to cover the cost of stem-cell transplantation, Dr. Furst said. For example, when enrolling patients into SCOT, insurers were willing to reimburse the treatment of about a quarter of the patients who otherwise qualified for enrollment, he said.

Dr. Khanna has received research grants from 14 different drug companies. Dr. Furst has been a consultant to or speaker for 11 different drug companies, and has received research grants from 10 different companies.

mzoler@frontlinemedcom.com On Twitter @mitchelzoler

PARIS – Autologous stem-cell transplantation has emerged as an effective and feasible treatment for selected patients with severe systemic sclerosis who inadequately respond to conventional treatments, said two U.S. experts.

In addition, convincing evidence documenting the overall beneficial effect of autologous stem-cell transplantation will soon appear in a published report from the Autologous Stem Cell Transplantation International Scleroderma (ASTIS) trial, Dr. Dinesh Khanna said in a talk at the annual European Congress of Rheumatology.

In his talk, Dr. Khanna gave a short preview of the ASTIS results that he said would appear in a medical journal in the next few weeks. Those results show that among 79 scleroderma patients randomized to treatment with autologous stem-cell transplant, 8 (10%) died from treatment-related causes, compared with none in the control arm of patients who received conventional treatment with cyclophosphamide. But during follow-up, a total of 16 of the 79 (20%) stem-cell transplant patients died, compared with 24 of the 77 (31%) control patients, results that showed an overall mortality benefit from stem-cell transplantation.

The transplanted patients also showed "large improvements" in their skin score and "substantial improvements" in their forced vital capacity and in their activity as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), noted Dr. Khanna, director of the scleroderma program at the University of Michigan in Ann Arbor.

"Before and after treatment, patients look completely different. Some patients [treated with stem-cell transplants] you can’t tell that they had scleroderma. But you need to select the right patients," he cautioned. "There is high mortality early, but if you select patients correctly the benefits will outweigh the risks. This is what we now offer to patients" who don’t respond to conventional treatments and are suitable for transplantation, Dr. Khanna said.

Researchers had previously reported these ASTIS results during the EULAR 2012 meeting.

Stem-cell treatment is appropriate for "the 10%-15% of patients with scleroderma who are the worst," commented Dr. Daniel Furst, a professor in rheumatology at the University of California, Los Angeles. "The next step is to move this treatment from the worst patients to those who are less severe. In some centers in Europe, stem-cell transplantation is becoming widely used, even for patients with only skin symptoms," Dr. Furst said in an interview.

A major attraction of stem-cell transplantation is that over time it produces regression of fibrosis and collagen deposits and healing of prior organ damage. But the treatment also carries the risk of causing substantial immunosuppression while the immune system repopulates, leaving patients vulnerable to infections and other complications.

The upcoming publication of the ASTIS findings should further cement the role of stem-cell transplantation in scleroderma management, but "I’m more of a skeptic. I would like to see it reproduced" in a second trial, Dr. Furst said. Specifically, he means the North American–based Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial now in progress. A positive result in SCOT is still needed to convince many insurers to cover the cost of stem-cell transplantation, Dr. Furst said. For example, when enrolling patients into SCOT, insurers were willing to reimburse the treatment of about a quarter of the patients who otherwise qualified for enrollment, he said.

Dr. Khanna has received research grants from 14 different drug companies. Dr. Furst has been a consultant to or speaker for 11 different drug companies, and has received research grants from 10 different companies.

mzoler@frontlinemedcom.com On Twitter @mitchelzoler

PARIS – Autologous stem-cell transplantation has emerged as an effective and feasible treatment for selected patients with severe systemic sclerosis who inadequately respond to conventional treatments, said two U.S. experts.

In addition, convincing evidence documenting the overall beneficial effect of autologous stem-cell transplantation will soon appear in a published report from the Autologous Stem Cell Transplantation International Scleroderma (ASTIS) trial, Dr. Dinesh Khanna said in a talk at the annual European Congress of Rheumatology.

In his talk, Dr. Khanna gave a short preview of the ASTIS results that he said would appear in a medical journal in the next few weeks. Those results show that among 79 scleroderma patients randomized to treatment with autologous stem-cell transplant, 8 (10%) died from treatment-related causes, compared with none in the control arm of patients who received conventional treatment with cyclophosphamide. But during follow-up, a total of 16 of the 79 (20%) stem-cell transplant patients died, compared with 24 of the 77 (31%) control patients, results that showed an overall mortality benefit from stem-cell transplantation.

The transplanted patients also showed "large improvements" in their skin score and "substantial improvements" in their forced vital capacity and in their activity as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), noted Dr. Khanna, director of the scleroderma program at the University of Michigan in Ann Arbor.

"Before and after treatment, patients look completely different. Some patients [treated with stem-cell transplants] you can’t tell that they had scleroderma. But you need to select the right patients," he cautioned. "There is high mortality early, but if you select patients correctly the benefits will outweigh the risks. This is what we now offer to patients" who don’t respond to conventional treatments and are suitable for transplantation, Dr. Khanna said.

Researchers had previously reported these ASTIS results during the EULAR 2012 meeting.

Stem-cell treatment is appropriate for "the 10%-15% of patients with scleroderma who are the worst," commented Dr. Daniel Furst, a professor in rheumatology at the University of California, Los Angeles. "The next step is to move this treatment from the worst patients to those who are less severe. In some centers in Europe, stem-cell transplantation is becoming widely used, even for patients with only skin symptoms," Dr. Furst said in an interview.

A major attraction of stem-cell transplantation is that over time it produces regression of fibrosis and collagen deposits and healing of prior organ damage. But the treatment also carries the risk of causing substantial immunosuppression while the immune system repopulates, leaving patients vulnerable to infections and other complications.

The upcoming publication of the ASTIS findings should further cement the role of stem-cell transplantation in scleroderma management, but "I’m more of a skeptic. I would like to see it reproduced" in a second trial, Dr. Furst said. Specifically, he means the North American–based Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial now in progress. A positive result in SCOT is still needed to convince many insurers to cover the cost of stem-cell transplantation, Dr. Furst said. For example, when enrolling patients into SCOT, insurers were willing to reimburse the treatment of about a quarter of the patients who otherwise qualified for enrollment, he said.

Dr. Khanna has received research grants from 14 different drug companies. Dr. Furst has been a consultant to or speaker for 11 different drug companies, and has received research grants from 10 different companies.

mzoler@frontlinemedcom.com On Twitter @mitchelzoler

PARIS – The traditional way to assess the status of interstitial lung disease in patients with systemic sclerosis, forced vital capacity, may not be the best way, based on a new analysis of 83 patients enrolled in a scleroderma-treatment trial.

"A structural, physiologic, and patient-oriented composite outcome may be a more comprehensive measure of treatment response" for patients with systemic sclerosis (SSc) and interstitial lung disease, Dr. Elizabeth Volkmann said at the annual European Congress of Rheumatology. "The most robust" association seen in her analysis did not include forced vital capacity (FVC) but instead focused on the Transition Dyspnea Index (TDI), the scleroderma modified Health Assessment Questionnaire Disability Index (HAQ-DI), and quantitative, serial assessment of high-resolution CT (HRCT) images of the patient’s lungs, said Dr. Volkmann, a rheumatologist at the University of California, Los Angeles.

Although her main goal in this analysis was to identify the best assessment of lung disease in SSc patients enrolled in clinical trials, the findings also have implications for managing patients with SSc, also known as scleroderma, in routine practice, Dr. Volkmann said in an interview.

Many physicians "rely solely on FVC for following patients, and I think this may not be the best measure. Now that we have great imaging options we should use them. And the strongest correlates [in the new analysis] were with the HAQ-DI, a measure of what patients can do, and the TDI, in which patients say how much their disease has progressed. They are both patient oriented and tell you how the patient is doing," Dr. Volkmann said.

"The three were more robust and comprehensive than FVC," which can be influenced by many factors and has a variability of 10%. Dr. Volkmann conceded that the quantitative assessment of annual HRCT scans done in the study is not widely available, but she said that visual assessment of HRCT scans highly correlates with quantitative assessment and hence likely makes a reasonable substitute.

A senior collaborator on the study, Dr. Daniel Furst, said that in his opinion it was premature to completely abandon FVC for assessing SSc patients, but it was clearly useful to add the two patient-oriented questionnaires and HRCT imaging.

"We haven’t discarded FVC, but we’ve added the other things," he said in an interview. "Five years ago we only did FVC, 3 years ago we added the scleroderma HAQ-DI," and now he and his associates also use annual HRCT imaging as well as the TDI. The two questionnaires are administered every 3-6 months, said Dr. Furst, professor of rheumatology at UCLA.

"Using all four of these tools is not being widely done" right now in U.S. rheumatology practice. "I really think it’s a step forward." However, Dr. Furst also cautioned that for adoption into routine practice he would like to see evidence documenting that this approach has a positive impact on patient outcomes.

Dr. Volkmann’s analysis involved the 158 U.S. patients enrolled in the first Scleroderma Lung Study, run in 2000-2004 at 13 U.S. centers to compare treatment with oral cyclophosphamide against placebo in patients with active SSC and interstitial lung disease (N. Engl. J. Med. 2006;354:2655-66). Of the 158 patients enrolled, 125 had an HRCT scan at baseline, and among those, 83 also had a HRCT scan after 12 months. These 83 patients formed the basis for Dr. Volkmann’s analysis, including 41 patients randomized to cyclophosphamide treatment and 42 randomized to placebo.

Multivariate analysis identified the HAQ-DI, TDI, FVC, and a quantitative lung fibrosis score derived from analysis of the serial HRCT images as collectively predicting best the outcomes of these patients. A second model that eliminated FVC was "slightly stronger," and both of these combined assessments were each "more robust than FVC alone," Dr. Volkmann said.

Dr. Volkmann said that she had no disclosures. Dr. Furst said that he had no relevant disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PARIS – The traditional way to assess the status of interstitial lung disease in patients with systemic sclerosis, forced vital capacity, may not be the best way, based on a new analysis of 83 patients enrolled in a scleroderma-treatment trial.

"A structural, physiologic, and patient-oriented composite outcome may be a more comprehensive measure of treatment response" for patients with systemic sclerosis (SSc) and interstitial lung disease, Dr. Elizabeth Volkmann said at the annual European Congress of Rheumatology. "The most robust" association seen in her analysis did not include forced vital capacity (FVC) but instead focused on the Transition Dyspnea Index (TDI), the scleroderma modified Health Assessment Questionnaire Disability Index (HAQ-DI), and quantitative, serial assessment of high-resolution CT (HRCT) images of the patient’s lungs, said Dr. Volkmann, a rheumatologist at the University of California, Los Angeles.

Although her main goal in this analysis was to identify the best assessment of lung disease in SSc patients enrolled in clinical trials, the findings also have implications for managing patients with SSc, also known as scleroderma, in routine practice, Dr. Volkmann said in an interview.

Many physicians "rely solely on FVC for following patients, and I think this may not be the best measure. Now that we have great imaging options we should use them. And the strongest correlates [in the new analysis] were with the HAQ-DI, a measure of what patients can do, and the TDI, in which patients say how much their disease has progressed. They are both patient oriented and tell you how the patient is doing," Dr. Volkmann said.

"The three were more robust and comprehensive than FVC," which can be influenced by many factors and has a variability of 10%. Dr. Volkmann conceded that the quantitative assessment of annual HRCT scans done in the study is not widely available, but she said that visual assessment of HRCT scans highly correlates with quantitative assessment and hence likely makes a reasonable substitute.

A senior collaborator on the study, Dr. Daniel Furst, said that in his opinion it was premature to completely abandon FVC for assessing SSc patients, but it was clearly useful to add the two patient-oriented questionnaires and HRCT imaging.

"We haven’t discarded FVC, but we’ve added the other things," he said in an interview. "Five years ago we only did FVC, 3 years ago we added the scleroderma HAQ-DI," and now he and his associates also use annual HRCT imaging as well as the TDI. The two questionnaires are administered every 3-6 months, said Dr. Furst, professor of rheumatology at UCLA.

"Using all four of these tools is not being widely done" right now in U.S. rheumatology practice. "I really think it’s a step forward." However, Dr. Furst also cautioned that for adoption into routine practice he would like to see evidence documenting that this approach has a positive impact on patient outcomes.

Dr. Volkmann’s analysis involved the 158 U.S. patients enrolled in the first Scleroderma Lung Study, run in 2000-2004 at 13 U.S. centers to compare treatment with oral cyclophosphamide against placebo in patients with active SSC and interstitial lung disease (N. Engl. J. Med. 2006;354:2655-66). Of the 158 patients enrolled, 125 had an HRCT scan at baseline, and among those, 83 also had a HRCT scan after 12 months. These 83 patients formed the basis for Dr. Volkmann’s analysis, including 41 patients randomized to cyclophosphamide treatment and 42 randomized to placebo.

Multivariate analysis identified the HAQ-DI, TDI, FVC, and a quantitative lung fibrosis score derived from analysis of the serial HRCT images as collectively predicting best the outcomes of these patients. A second model that eliminated FVC was "slightly stronger," and both of these combined assessments were each "more robust than FVC alone," Dr. Volkmann said.

Dr. Volkmann said that she had no disclosures. Dr. Furst said that he had no relevant disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PARIS – The traditional way to assess the status of interstitial lung disease in patients with systemic sclerosis, forced vital capacity, may not be the best way, based on a new analysis of 83 patients enrolled in a scleroderma-treatment trial.

"A structural, physiologic, and patient-oriented composite outcome may be a more comprehensive measure of treatment response" for patients with systemic sclerosis (SSc) and interstitial lung disease, Dr. Elizabeth Volkmann said at the annual European Congress of Rheumatology. "The most robust" association seen in her analysis did not include forced vital capacity (FVC) but instead focused on the Transition Dyspnea Index (TDI), the scleroderma modified Health Assessment Questionnaire Disability Index (HAQ-DI), and quantitative, serial assessment of high-resolution CT (HRCT) images of the patient’s lungs, said Dr. Volkmann, a rheumatologist at the University of California, Los Angeles.

Although her main goal in this analysis was to identify the best assessment of lung disease in SSc patients enrolled in clinical trials, the findings also have implications for managing patients with SSc, also known as scleroderma, in routine practice, Dr. Volkmann said in an interview.

Many physicians "rely solely on FVC for following patients, and I think this may not be the best measure. Now that we have great imaging options we should use them. And the strongest correlates [in the new analysis] were with the HAQ-DI, a measure of what patients can do, and the TDI, in which patients say how much their disease has progressed. They are both patient oriented and tell you how the patient is doing," Dr. Volkmann said.

"The three were more robust and comprehensive than FVC," which can be influenced by many factors and has a variability of 10%. Dr. Volkmann conceded that the quantitative assessment of annual HRCT scans done in the study is not widely available, but she said that visual assessment of HRCT scans highly correlates with quantitative assessment and hence likely makes a reasonable substitute.

A senior collaborator on the study, Dr. Daniel Furst, said that in his opinion it was premature to completely abandon FVC for assessing SSc patients, but it was clearly useful to add the two patient-oriented questionnaires and HRCT imaging.

"We haven’t discarded FVC, but we’ve added the other things," he said in an interview. "Five years ago we only did FVC, 3 years ago we added the scleroderma HAQ-DI," and now he and his associates also use annual HRCT imaging as well as the TDI. The two questionnaires are administered every 3-6 months, said Dr. Furst, professor of rheumatology at UCLA.

"Using all four of these tools is not being widely done" right now in U.S. rheumatology practice. "I really think it’s a step forward." However, Dr. Furst also cautioned that for adoption into routine practice he would like to see evidence documenting that this approach has a positive impact on patient outcomes.

Dr. Volkmann’s analysis involved the 158 U.S. patients enrolled in the first Scleroderma Lung Study, run in 2000-2004 at 13 U.S. centers to compare treatment with oral cyclophosphamide against placebo in patients with active SSC and interstitial lung disease (N. Engl. J. Med. 2006;354:2655-66). Of the 158 patients enrolled, 125 had an HRCT scan at baseline, and among those, 83 also had a HRCT scan after 12 months. These 83 patients formed the basis for Dr. Volkmann’s analysis, including 41 patients randomized to cyclophosphamide treatment and 42 randomized to placebo.

Multivariate analysis identified the HAQ-DI, TDI, FVC, and a quantitative lung fibrosis score derived from analysis of the serial HRCT images as collectively predicting best the outcomes of these patients. A second model that eliminated FVC was "slightly stronger," and both of these combined assessments were each "more robust than FVC alone," Dr. Volkmann said.

Dr. Volkmann said that she had no disclosures. Dr. Furst said that he had no relevant disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

MINNEAPOLIS – People with chronic insomnia don’t have to take the sedative-hypnotic agent zolpidem every night for it to remain efficacious, a randomized trial found.

Investigators enrolled in the trial 56 patients who had had a response to a priming phase of 4 weeks of nightly zolpidem (Ambien) 10 mg and assigned them to three maintenance strategies: nightly dosing, intermittent dosing (whereby the drug was taken 3-5 nights per week of the patient’s choice), and partial reinforcement dosing (whereby a capsule was taken every night, but half were placebos).

Use of partial reinforcement after a priming phase, during which the drug is repeatedly paired with sleep, taps into the phenomenon of conditioning, explained lead author Michael Perlis, Ph.D., director of the behavioral sleep medicine program, University of Pennsylvania, Philadelphia. "In this kind of paradigm, on the nights when there is no medication, they are getting a conditioned response; on the nights when there is medication, you are reinforcing the capsule as the conditioned stimulus for that physiologic response."

Analyses based on the 41 compliant patients showed that after 1 month, the three maintenance regimens were statistically indistinguishable in terms of measures such as time to relapse, sleep latency, and waking after sleep onset.

Total sleep time was longer with nightly dosing (463 minutes) and partial reinforcement dosing (459 minutes) than with intermittent dosing (429 minutes) (P = .002 across groups). Also, sleep efficiency was better with nightly dosing (90%) and partial reinforcement (91%) than with intermittent dosing (88%) (P = .002 across groups).

The frequency of medical symptoms, possibly adverse effects, was statistically indistinguishable across groups, although they tended to be least frequent with the partial reinforcement strategy and most with the intermittent dosing strategy.

"The present findings suggest that in compliant subjects, any of the three 10-mg strategies evaluated may be used to maintain treatment response over time. If a trend is evident, it’s that subjects in the intermittent dosing group condition do not do as well as nightly dosing and as in partial reinforcement, and that’s especially and significantly true for total sleep time and sleep efficiency," Dr. Perlis commented. "The take-home message is interspersing placebos between active doses appears to be a reasonable approach for maintaining clinical gains following priming, in other words, obtention of treatment response with a full-dose strategy."

In upcoming research, the investigators plan to see how low they can go with the partial reinforcement strategy as far as nights of zolpidem – even down to zero capsules of active drug – and still maintain the benefit of nightly dosing. If this proves successful, "then it may be possible to one, maintain treatment response for long periods of time with fractional amounts of medication. Second, we have a potential to reduce tolerance and side effect risks. Third, we would massively be able to reduce the cost of maintenance therapy considering placebos are basically free," he said.

"Finally and most important..., if this approach works as applied to insomnia, it may be a powerful tool for the management of medications with narrow therapeutic indices. Put differently, the partial reinforcement approach may be a strategy for managing medications that have nearly as much risk as they do benefit. That’s where the money is," said Dr. Perlis, who disclosed no relevant conflicts of interest.

In an interview, Brandy Roane, Ph.D., one of the session cochairs and a psychologist at the University of North Texas Health Science Center in Fort Worth, noted that the study is interesting in that it sheds light on why patients on intermittent dosing might become increasingly dependent on the medication.

"You have the patient who becomes more likely to increase their use even if it’s not effective, because they end up taking that dose on the night when they do sleep better because it would be a typical what we call crash night, where their body is already so physically fatigued and their homeostatic sleep pressure is so increased that they take it and it pairs it with that [sleep], and it’s a learned response: ‘I took medication and I slept so much better.’ Whereas if you hadn’t paired it with that, they would have slept better anyway," she explained.

"So I think it does look more at that real world type of setting and starts to speak to some of that possible use actually increasing the likelihood that they are going to take the medication, whether it’s effective or not, and then not use behavioral interventions that might be more effective."

Colin A. Espie, Ph.D., the other session cochair and a professor of sleep medicine in the Nuffield Department of Clinical Neuroscience at the University of Oxford (England), commented: "This is theoretically quite an interesting study. I think there might be some ethical problems in devising a practice whereby you systematically give people placebo without their knowledge, so I’m not sure it’s a very usable clinical strategy. But I think it’s an interesting paradigm to understand more about the placebo effect."

Dr. Perlis disclosed no relevant conflicts of interest.

MINNEAPOLIS – People with chronic insomnia don’t have to take the sedative-hypnotic agent zolpidem every night for it to remain efficacious, a randomized trial found.

Investigators enrolled in the trial 56 patients who had had a response to a priming phase of 4 weeks of nightly zolpidem (Ambien) 10 mg and assigned them to three maintenance strategies: nightly dosing, intermittent dosing (whereby the drug was taken 3-5 nights per week of the patient’s choice), and partial reinforcement dosing (whereby a capsule was taken every night, but half were placebos).

Use of partial reinforcement after a priming phase, during which the drug is repeatedly paired with sleep, taps into the phenomenon of conditioning, explained lead author Michael Perlis, Ph.D., director of the behavioral sleep medicine program, University of Pennsylvania, Philadelphia. "In this kind of paradigm, on the nights when there is no medication, they are getting a conditioned response; on the nights when there is medication, you are reinforcing the capsule as the conditioned stimulus for that physiologic response."

Analyses based on the 41 compliant patients showed that after 1 month, the three maintenance regimens were statistically indistinguishable in terms of measures such as time to relapse, sleep latency, and waking after sleep onset.

Total sleep time was longer with nightly dosing (463 minutes) and partial reinforcement dosing (459 minutes) than with intermittent dosing (429 minutes) (P = .002 across groups). Also, sleep efficiency was better with nightly dosing (90%) and partial reinforcement (91%) than with intermittent dosing (88%) (P = .002 across groups).

The frequency of medical symptoms, possibly adverse effects, was statistically indistinguishable across groups, although they tended to be least frequent with the partial reinforcement strategy and most with the intermittent dosing strategy.

"The present findings suggest that in compliant subjects, any of the three 10-mg strategies evaluated may be used to maintain treatment response over time. If a trend is evident, it’s that subjects in the intermittent dosing group condition do not do as well as nightly dosing and as in partial reinforcement, and that’s especially and significantly true for total sleep time and sleep efficiency," Dr. Perlis commented. "The take-home message is interspersing placebos between active doses appears to be a reasonable approach for maintaining clinical gains following priming, in other words, obtention of treatment response with a full-dose strategy."

In upcoming research, the investigators plan to see how low they can go with the partial reinforcement strategy as far as nights of zolpidem – even down to zero capsules of active drug – and still maintain the benefit of nightly dosing. If this proves successful, "then it may be possible to one, maintain treatment response for long periods of time with fractional amounts of medication. Second, we have a potential to reduce tolerance and side effect risks. Third, we would massively be able to reduce the cost of maintenance therapy considering placebos are basically free," he said.

"Finally and most important..., if this approach works as applied to insomnia, it may be a powerful tool for the management of medications with narrow therapeutic indices. Put differently, the partial reinforcement approach may be a strategy for managing medications that have nearly as much risk as they do benefit. That’s where the money is," said Dr. Perlis, who disclosed no relevant conflicts of interest.

In an interview, Brandy Roane, Ph.D., one of the session cochairs and a psychologist at the University of North Texas Health Science Center in Fort Worth, noted that the study is interesting in that it sheds light on why patients on intermittent dosing might become increasingly dependent on the medication.

"You have the patient who becomes more likely to increase their use even if it’s not effective, because they end up taking that dose on the night when they do sleep better because it would be a typical what we call crash night, where their body is already so physically fatigued and their homeostatic sleep pressure is so increased that they take it and it pairs it with that [sleep], and it’s a learned response: ‘I took medication and I slept so much better.’ Whereas if you hadn’t paired it with that, they would have slept better anyway," she explained.

"So I think it does look more at that real world type of setting and starts to speak to some of that possible use actually increasing the likelihood that they are going to take the medication, whether it’s effective or not, and then not use behavioral interventions that might be more effective."

Colin A. Espie, Ph.D., the other session cochair and a professor of sleep medicine in the Nuffield Department of Clinical Neuroscience at the University of Oxford (England), commented: "This is theoretically quite an interesting study. I think there might be some ethical problems in devising a practice whereby you systematically give people placebo without their knowledge, so I’m not sure it’s a very usable clinical strategy. But I think it’s an interesting paradigm to understand more about the placebo effect."

Dr. Perlis disclosed no relevant conflicts of interest.

MINNEAPOLIS – People with chronic insomnia don’t have to take the sedative-hypnotic agent zolpidem every night for it to remain efficacious, a randomized trial found.

Investigators enrolled in the trial 56 patients who had had a response to a priming phase of 4 weeks of nightly zolpidem (Ambien) 10 mg and assigned them to three maintenance strategies: nightly dosing, intermittent dosing (whereby the drug was taken 3-5 nights per week of the patient’s choice), and partial reinforcement dosing (whereby a capsule was taken every night, but half were placebos).

Use of partial reinforcement after a priming phase, during which the drug is repeatedly paired with sleep, taps into the phenomenon of conditioning, explained lead author Michael Perlis, Ph.D., director of the behavioral sleep medicine program, University of Pennsylvania, Philadelphia. "In this kind of paradigm, on the nights when there is no medication, they are getting a conditioned response; on the nights when there is medication, you are reinforcing the capsule as the conditioned stimulus for that physiologic response."

Analyses based on the 41 compliant patients showed that after 1 month, the three maintenance regimens were statistically indistinguishable in terms of measures such as time to relapse, sleep latency, and waking after sleep onset.

Total sleep time was longer with nightly dosing (463 minutes) and partial reinforcement dosing (459 minutes) than with intermittent dosing (429 minutes) (P = .002 across groups). Also, sleep efficiency was better with nightly dosing (90%) and partial reinforcement (91%) than with intermittent dosing (88%) (P = .002 across groups).

The frequency of medical symptoms, possibly adverse effects, was statistically indistinguishable across groups, although they tended to be least frequent with the partial reinforcement strategy and most with the intermittent dosing strategy.

"The present findings suggest that in compliant subjects, any of the three 10-mg strategies evaluated may be used to maintain treatment response over time. If a trend is evident, it’s that subjects in the intermittent dosing group condition do not do as well as nightly dosing and as in partial reinforcement, and that’s especially and significantly true for total sleep time and sleep efficiency," Dr. Perlis commented. "The take-home message is interspersing placebos between active doses appears to be a reasonable approach for maintaining clinical gains following priming, in other words, obtention of treatment response with a full-dose strategy."

In upcoming research, the investigators plan to see how low they can go with the partial reinforcement strategy as far as nights of zolpidem – even down to zero capsules of active drug – and still maintain the benefit of nightly dosing. If this proves successful, "then it may be possible to one, maintain treatment response for long periods of time with fractional amounts of medication. Second, we have a potential to reduce tolerance and side effect risks. Third, we would massively be able to reduce the cost of maintenance therapy considering placebos are basically free," he said.

"Finally and most important..., if this approach works as applied to insomnia, it may be a powerful tool for the management of medications with narrow therapeutic indices. Put differently, the partial reinforcement approach may be a strategy for managing medications that have nearly as much risk as they do benefit. That’s where the money is," said Dr. Perlis, who disclosed no relevant conflicts of interest.

In an interview, Brandy Roane, Ph.D., one of the session cochairs and a psychologist at the University of North Texas Health Science Center in Fort Worth, noted that the study is interesting in that it sheds light on why patients on intermittent dosing might become increasingly dependent on the medication.

"You have the patient who becomes more likely to increase their use even if it’s not effective, because they end up taking that dose on the night when they do sleep better because it would be a typical what we call crash night, where their body is already so physically fatigued and their homeostatic sleep pressure is so increased that they take it and it pairs it with that [sleep], and it’s a learned response: ‘I took medication and I slept so much better.’ Whereas if you hadn’t paired it with that, they would have slept better anyway," she explained.

"So I think it does look more at that real world type of setting and starts to speak to some of that possible use actually increasing the likelihood that they are going to take the medication, whether it’s effective or not, and then not use behavioral interventions that might be more effective."

Colin A. Espie, Ph.D., the other session cochair and a professor of sleep medicine in the Nuffield Department of Clinical Neuroscience at the University of Oxford (England), commented: "This is theoretically quite an interesting study. I think there might be some ethical problems in devising a practice whereby you systematically give people placebo without their knowledge, so I’m not sure it’s a very usable clinical strategy. But I think it’s an interesting paradigm to understand more about the placebo effect."

Dr. Perlis disclosed no relevant conflicts of interest.

MINNEAPOLIS – Continuous positive airway pressure works similarly well at lowering blood pressure in real-world clinical practice as in clinical trials, according to a cohort study of 880 patients with sleep-disordered breathing and hypertension.

The patients, 598 with hypertension that responded to therapy and 282 with idiopathic resistant hypertension, were all treated at a tertiary-care sleep disorders center between 2010 and 2013.

On average, a year after starting continuous positive airway pressure (CPAP), they had a reduction of 3.0 mm Hg in systolic blood pressure, 2.2 mm Hg in diastolic blood pressure, and 2.5 mm Hg in mean arterial pressure in analyses adjusted for potential confounders, researchers reported at the annual meeting of the Associated Professional Sleep Societies.

The benefit was similar regardless of whether hypertension was resistant or not, although patients with the resistant form had higher blood pressure – especially systolic blood pressure – at this time point.

"Our real-world experience is consistent with the blood pressure reduction seen with the use of CPAP in the rigorous clinical trials," commented lead researcher Dr. Harneet K. Walia, assistant professor of family medicine with the sleep disorders center at the Cleveland Clinic. "The clinic-based effectiveness data of CPAP on blood pressure in this pragmatic clinical study were similar in the resistant hypertension and non–resistant hypertension groups."

Study findings were essentially the same when neck size was substituted for body mass index as a potential confounder (although the multivariate model had a better fit) and when analyses were restricted to the 82% of patients who were adherent to CPAP, according to self-report.

In an interview, session cochair Dr. Cathy Anne Goldstein, assistant professor of neurology at the University of Michigan, Ann Arbor, said, "This is a promising study that does show the association of treating obstructive sleep apnea with CPAP and reducing blood pressure. This was nice because it showed it wasn’t just the patients who were refractory – it was all comers with hypertension who had a benefit."

"This isn’t new, but it’s confirmatory of what some other studies have shown," she added. "The more information we can get, the better, because there have been some conflicting results."

Dr. Walia disclosed no relevant conflicts of interest.

MINNEAPOLIS – Continuous positive airway pressure works similarly well at lowering blood pressure in real-world clinical practice as in clinical trials, according to a cohort study of 880 patients with sleep-disordered breathing and hypertension.

The patients, 598 with hypertension that responded to therapy and 282 with idiopathic resistant hypertension, were all treated at a tertiary-care sleep disorders center between 2010 and 2013.

On average, a year after starting continuous positive airway pressure (CPAP), they had a reduction of 3.0 mm Hg in systolic blood pressure, 2.2 mm Hg in diastolic blood pressure, and 2.5 mm Hg in mean arterial pressure in analyses adjusted for potential confounders, researchers reported at the annual meeting of the Associated Professional Sleep Societies.

The benefit was similar regardless of whether hypertension was resistant or not, although patients with the resistant form had higher blood pressure – especially systolic blood pressure – at this time point.

"Our real-world experience is consistent with the blood pressure reduction seen with the use of CPAP in the rigorous clinical trials," commented lead researcher Dr. Harneet K. Walia, assistant professor of family medicine with the sleep disorders center at the Cleveland Clinic. "The clinic-based effectiveness data of CPAP on blood pressure in this pragmatic clinical study were similar in the resistant hypertension and non–resistant hypertension groups."

Study findings were essentially the same when neck size was substituted for body mass index as a potential confounder (although the multivariate model had a better fit) and when analyses were restricted to the 82% of patients who were adherent to CPAP, according to self-report.

In an interview, session cochair Dr. Cathy Anne Goldstein, assistant professor of neurology at the University of Michigan, Ann Arbor, said, "This is a promising study that does show the association of treating obstructive sleep apnea with CPAP and reducing blood pressure. This was nice because it showed it wasn’t just the patients who were refractory – it was all comers with hypertension who had a benefit."

"This isn’t new, but it’s confirmatory of what some other studies have shown," she added. "The more information we can get, the better, because there have been some conflicting results."

Dr. Walia disclosed no relevant conflicts of interest.

MINNEAPOLIS – Continuous positive airway pressure works similarly well at lowering blood pressure in real-world clinical practice as in clinical trials, according to a cohort study of 880 patients with sleep-disordered breathing and hypertension.

The patients, 598 with hypertension that responded to therapy and 282 with idiopathic resistant hypertension, were all treated at a tertiary-care sleep disorders center between 2010 and 2013.

On average, a year after starting continuous positive airway pressure (CPAP), they had a reduction of 3.0 mm Hg in systolic blood pressure, 2.2 mm Hg in diastolic blood pressure, and 2.5 mm Hg in mean arterial pressure in analyses adjusted for potential confounders, researchers reported at the annual meeting of the Associated Professional Sleep Societies.

The benefit was similar regardless of whether hypertension was resistant or not, although patients with the resistant form had higher blood pressure – especially systolic blood pressure – at this time point.

"Our real-world experience is consistent with the blood pressure reduction seen with the use of CPAP in the rigorous clinical trials," commented lead researcher Dr. Harneet K. Walia, assistant professor of family medicine with the sleep disorders center at the Cleveland Clinic. "The clinic-based effectiveness data of CPAP on blood pressure in this pragmatic clinical study were similar in the resistant hypertension and non–resistant hypertension groups."

Study findings were essentially the same when neck size was substituted for body mass index as a potential confounder (although the multivariate model had a better fit) and when analyses were restricted to the 82% of patients who were adherent to CPAP, according to self-report.

In an interview, session cochair Dr. Cathy Anne Goldstein, assistant professor of neurology at the University of Michigan, Ann Arbor, said, "This is a promising study that does show the association of treating obstructive sleep apnea with CPAP and reducing blood pressure. This was nice because it showed it wasn’t just the patients who were refractory – it was all comers with hypertension who had a benefit."

"This isn’t new, but it’s confirmatory of what some other studies have shown," she added. "The more information we can get, the better, because there have been some conflicting results."

Dr. Walia disclosed no relevant conflicts of interest.

Two U.S. individuals who contracted Middle East Respiratory Syndrome coronavirus (MERS-CoV) did not transmit the virus to members of their households or to health care workers, officials at the Centers for Disease Control and Prevention say.

Both patients with confirmed infections, one in Florida and another in Indiana, had traveled to Saudi Arabia before becoming ill.

Polymerase chain reaction assays and serology revealed no evidence of previous or active infection in any members of their households or healthcare workers who attended them.

In a press statement June 17, Dr. David Swerdlow, who is leading the agency’s MERS-CoV response, called the negative results among contacts that the CDC considered at highest risk for MERS-CoV infection "reassuring."

While the risk MERS-CoV infection in the United States remains low, Dr. Swerdlow added, "it is important that we remain vigilant and quickly identify and respond to any additional importations."

Two U.S. individuals who contracted Middle East Respiratory Syndrome coronavirus (MERS-CoV) did not transmit the virus to members of their households or to health care workers, officials at the Centers for Disease Control and Prevention say.

Both patients with confirmed infections, one in Florida and another in Indiana, had traveled to Saudi Arabia before becoming ill.

Polymerase chain reaction assays and serology revealed no evidence of previous or active infection in any members of their households or healthcare workers who attended them.

In a press statement June 17, Dr. David Swerdlow, who is leading the agency’s MERS-CoV response, called the negative results among contacts that the CDC considered at highest risk for MERS-CoV infection "reassuring."

While the risk MERS-CoV infection in the United States remains low, Dr. Swerdlow added, "it is important that we remain vigilant and quickly identify and respond to any additional importations."

Two U.S. individuals who contracted Middle East Respiratory Syndrome coronavirus (MERS-CoV) did not transmit the virus to members of their households or to health care workers, officials at the Centers for Disease Control and Prevention say.

Both patients with confirmed infections, one in Florida and another in Indiana, had traveled to Saudi Arabia before becoming ill.

Polymerase chain reaction assays and serology revealed no evidence of previous or active infection in any members of their households or healthcare workers who attended them.

In a press statement June 17, Dr. David Swerdlow, who is leading the agency’s MERS-CoV response, called the negative results among contacts that the CDC considered at highest risk for MERS-CoV infection "reassuring."

While the risk MERS-CoV infection in the United States remains low, Dr. Swerdlow added, "it is important that we remain vigilant and quickly identify and respond to any additional importations."

MINNEAPOLIS – Sleep apnea is associated with neurocognitive dysfunction in adult Hispanics living in the United States, research presented at the annual meeting of the Associated Professional Sleep Societies shows.

In unadjusted models, sleep apnea, as assessed by the apnea-hypopnea index (AHI), was inversely associated with neurocognitive dysfunction in both men and women.

"However, after adjusting for covariates, these interactions were attenuated," reported Dr. Alberto R. Ramos. "In a fully adjusted model accounting for age, BMI [body mass index], tobacco use, depression and anxiety scores, stroke, diabetes, hypertension, and field center tested, this association was seen only in women, but not in men."

Dr. Ramos of the department of clinical neurology at the University of Miami and his colleagues conducted a cross-sectional analysis of 9,714 Hispanic men and women between the ages of 45 and 74 who were participants in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). The researchers sought to determine the extent to which sleep apnea contributes to neurocognitive dysfunction in a representative sample of Hispanic men and women residing in the United States.

Subjects were administered multiple neurocognitive tests, assessing learning, recall, word fluency, and digit symbol substitution. Obstructive sleep apnea was determined objectively using the apnea risk evaluation system and defined by the apnea-hypopnea index (AHI), and subjectively using standardized sleep symptom scales.

The mean AHI was 8.9, 11.5 for men and 6.8 for women (P less than 0.001 for difference between genders). With increasing age, the AHI significantly increased, too, from 7.4 in subjects aged 45 to 54, to 11.5 in those aged 65 to 74 (P less than 0.001).

Dementia prevalence is on the rise, particularly among Hispanics/Latinos who are up to 3.3 times more likely to meet diagnostic criteria for advanced dementia, compared with non-Hispanic whites, Dr. Ramos reported.

Dr. Ramos reported having no disclosures. The study received support from multiple National Heart, Lung, and Blood Institute grants.

MINNEAPOLIS – Sleep apnea is associated with neurocognitive dysfunction in adult Hispanics living in the United States, research presented at the annual meeting of the Associated Professional Sleep Societies shows.

In unadjusted models, sleep apnea, as assessed by the apnea-hypopnea index (AHI), was inversely associated with neurocognitive dysfunction in both men and women.

"However, after adjusting for covariates, these interactions were attenuated," reported Dr. Alberto R. Ramos. "In a fully adjusted model accounting for age, BMI [body mass index], tobacco use, depression and anxiety scores, stroke, diabetes, hypertension, and field center tested, this association was seen only in women, but not in men."

Dr. Ramos of the department of clinical neurology at the University of Miami and his colleagues conducted a cross-sectional analysis of 9,714 Hispanic men and women between the ages of 45 and 74 who were participants in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). The researchers sought to determine the extent to which sleep apnea contributes to neurocognitive dysfunction in a representative sample of Hispanic men and women residing in the United States.

Subjects were administered multiple neurocognitive tests, assessing learning, recall, word fluency, and digit symbol substitution. Obstructive sleep apnea was determined objectively using the apnea risk evaluation system and defined by the apnea-hypopnea index (AHI), and subjectively using standardized sleep symptom scales.

The mean AHI was 8.9, 11.5 for men and 6.8 for women (P less than 0.001 for difference between genders). With increasing age, the AHI significantly increased, too, from 7.4 in subjects aged 45 to 54, to 11.5 in those aged 65 to 74 (P less than 0.001).

Dementia prevalence is on the rise, particularly among Hispanics/Latinos who are up to 3.3 times more likely to meet diagnostic criteria for advanced dementia, compared with non-Hispanic whites, Dr. Ramos reported.

Dr. Ramos reported having no disclosures. The study received support from multiple National Heart, Lung, and Blood Institute grants.

MINNEAPOLIS – Sleep apnea is associated with neurocognitive dysfunction in adult Hispanics living in the United States, research presented at the annual meeting of the Associated Professional Sleep Societies shows.

In unadjusted models, sleep apnea, as assessed by the apnea-hypopnea index (AHI), was inversely associated with neurocognitive dysfunction in both men and women.

"However, after adjusting for covariates, these interactions were attenuated," reported Dr. Alberto R. Ramos. "In a fully adjusted model accounting for age, BMI [body mass index], tobacco use, depression and anxiety scores, stroke, diabetes, hypertension, and field center tested, this association was seen only in women, but not in men."

Dr. Ramos of the department of clinical neurology at the University of Miami and his colleagues conducted a cross-sectional analysis of 9,714 Hispanic men and women between the ages of 45 and 74 who were participants in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). The researchers sought to determine the extent to which sleep apnea contributes to neurocognitive dysfunction in a representative sample of Hispanic men and women residing in the United States.

Subjects were administered multiple neurocognitive tests, assessing learning, recall, word fluency, and digit symbol substitution. Obstructive sleep apnea was determined objectively using the apnea risk evaluation system and defined by the apnea-hypopnea index (AHI), and subjectively using standardized sleep symptom scales.

The mean AHI was 8.9, 11.5 for men and 6.8 for women (P less than 0.001 for difference between genders). With increasing age, the AHI significantly increased, too, from 7.4 in subjects aged 45 to 54, to 11.5 in those aged 65 to 74 (P less than 0.001).

Dementia prevalence is on the rise, particularly among Hispanics/Latinos who are up to 3.3 times more likely to meet diagnostic criteria for advanced dementia, compared with non-Hispanic whites, Dr. Ramos reported.

Dr. Ramos reported having no disclosures. The study received support from multiple National Heart, Lung, and Blood Institute grants.

MINNEAPOLIS – College students who do not get enough sleep experience an impact on their academic performance that is on par with binge drinking or regular marijuana use, two researchers say.

"The cultural assumption is that college is a time of bad sleep, and that all-nighters fueled by energy drinks and cheap pizza are just an inherent part of what it means to be a student," investigators J. Roxanne Prichard, Ph.D., and Monica Hartmann, Ph.D., reported at the annual meeting of the Associated Professional Sleep Societies.

But they say that assumption is shortsighted and wrong. "Well-rested students perform better academically and are healthier physically and psychologically," the researchers said.

Dr. Prichard of the department of neuroscience at the University of St. Thomas, St. Paul, Minn., and Dr. Hartmann,professor of economics at the university analyzed data from the Spring 2009 NCHA (the American College Health Association National College Health Assessment), which included survey information from 72, 966 students, 63% of whom were female and 75% of whom were white.

Students who participated in the survey were asked about their physical and mental health, sexual activity, and substance use, among other issues. They also were asked whether they’ve had sleep problems or had been diagnosed with a sleep disorder or insomnia.

Using data from more than 43,000 respondents, the researchers attempted to evaluate factors that predicted academic problems, including dropping a course, earning a lower course grade, and having a lower cumulative grade point average. The researchers examined those impacts for all students but focused on freshmen, because first-year performance "has such a large effect on retention rates and thus the economic stability for the institution of higher education," the researchers said. They found that sleep timing and sleep-related problems in college students were a strong predictor of academic problems, even after they controlled for other factors that might have had an impact, including clinical depression, feeling isolated, and a diagnosis of a learning disability or chronic health issue.

Students who earned "A" grades reported experiencing fewer of the following sleep issues: early awakenings, feeling sleepy during the day, going to bed early because they could not stay awake, or having trouble falling asleep. Students with worse grades tended to report more sleep issues.

Sleep problems had about the same impact on GPA as did binge drinking and marijuana use, the authors reported. In freshmen, poor sleep was an independent predictor of whether a student would drop or withdraw from a course. The authors adjusted their analysis to account for race, gender, work hours, chronic illness, and psychiatric problems such as anxiety.

Reducing sleep problems might have had a greater impact than reducing binge drinking or marijuana use, they said. For instance, improving sleep on just 1 night a week reduced the probability that a freshman drops a course by about 15%, the authors found.

Dr. Prichard and Dr. Hartmann also tried to gauge the effect that sleep disturbances in college eventually might have on the university’s ability to keep the student and the student’s future earnings potential. They determined that a sleep screening program that identified students at risk and led to treatment would be cost effective, even for the smallest universities. "Identifying and treating students with undiagnosed sleep problems early on in a student’s career economically benefits the university through increased retention and increases the students’ lifetime earning potential," they said.

But they noted that most institutions of higher learning do not pay much attention to students’ sleep habits. Rarely is there any time or money devoted to improving sleep, and if there is, it’s much less than the amount spent to address learning disabilities, substance abuse, and contagious illness, the researchers said. They encouraged a reexamination of the resources directed toward sleep quality in this population.

Dr. Prichard and Dr. Hartmann reported no conflicts. They received no outside funding for the study.

aault@frontlinemedcom.com

On Twitter @aliciaault

MINNEAPOLIS – College students who do not get enough sleep experience an impact on their academic performance that is on par with binge drinking or regular marijuana use, two researchers say.

"The cultural assumption is that college is a time of bad sleep, and that all-nighters fueled by energy drinks and cheap pizza are just an inherent part of what it means to be a student," investigators J. Roxanne Prichard, Ph.D., and Monica Hartmann, Ph.D., reported at the annual meeting of the Associated Professional Sleep Societies.

But they say that assumption is shortsighted and wrong. "Well-rested students perform better academically and are healthier physically and psychologically," the researchers said.

Dr. Prichard of the department of neuroscience at the University of St. Thomas, St. Paul, Minn., and Dr. Hartmann,professor of economics at the university analyzed data from the Spring 2009 NCHA (the American College Health Association National College Health Assessment), which included survey information from 72, 966 students, 63% of whom were female and 75% of whom were white.

Students who participated in the survey were asked about their physical and mental health, sexual activity, and substance use, among other issues. They also were asked whether they’ve had sleep problems or had been diagnosed with a sleep disorder or insomnia.

Using data from more than 43,000 respondents, the researchers attempted to evaluate factors that predicted academic problems, including dropping a course, earning a lower course grade, and having a lower cumulative grade point average. The researchers examined those impacts for all students but focused on freshmen, because first-year performance "has such a large effect on retention rates and thus the economic stability for the institution of higher education," the researchers said. They found that sleep timing and sleep-related problems in college students were a strong predictor of academic problems, even after they controlled for other factors that might have had an impact, including clinical depression, feeling isolated, and a diagnosis of a learning disability or chronic health issue.

Students who earned "A" grades reported experiencing fewer of the following sleep issues: early awakenings, feeling sleepy during the day, going to bed early because they could not stay awake, or having trouble falling asleep. Students with worse grades tended to report more sleep issues.

Sleep problems had about the same impact on GPA as did binge drinking and marijuana use, the authors reported. In freshmen, poor sleep was an independent predictor of whether a student would drop or withdraw from a course. The authors adjusted their analysis to account for race, gender, work hours, chronic illness, and psychiatric problems such as anxiety.

Reducing sleep problems might have had a greater impact than reducing binge drinking or marijuana use, they said. For instance, improving sleep on just 1 night a week reduced the probability that a freshman drops a course by about 15%, the authors found.

Dr. Prichard and Dr. Hartmann also tried to gauge the effect that sleep disturbances in college eventually might have on the university’s ability to keep the student and the student’s future earnings potential. They determined that a sleep screening program that identified students at risk and led to treatment would be cost effective, even for the smallest universities. "Identifying and treating students with undiagnosed sleep problems early on in a student’s career economically benefits the university through increased retention and increases the students’ lifetime earning potential," they said.

But they noted that most institutions of higher learning do not pay much attention to students’ sleep habits. Rarely is there any time or money devoted to improving sleep, and if there is, it’s much less than the amount spent to address learning disabilities, substance abuse, and contagious illness, the researchers said. They encouraged a reexamination of the resources directed toward sleep quality in this population.

Dr. Prichard and Dr. Hartmann reported no conflicts. They received no outside funding for the study.

aault@frontlinemedcom.com

On Twitter @aliciaault

MINNEAPOLIS – College students who do not get enough sleep experience an impact on their academic performance that is on par with binge drinking or regular marijuana use, two researchers say.

"The cultural assumption is that college is a time of bad sleep, and that all-nighters fueled by energy drinks and cheap pizza are just an inherent part of what it means to be a student," investigators J. Roxanne Prichard, Ph.D., and Monica Hartmann, Ph.D., reported at the annual meeting of the Associated Professional Sleep Societies.

But they say that assumption is shortsighted and wrong. "Well-rested students perform better academically and are healthier physically and psychologically," the researchers said.

Dr. Prichard of the department of neuroscience at the University of St. Thomas, St. Paul, Minn., and Dr. Hartmann,professor of economics at the university analyzed data from the Spring 2009 NCHA (the American College Health Association National College Health Assessment), which included survey information from 72, 966 students, 63% of whom were female and 75% of whom were white.

Students who participated in the survey were asked about their physical and mental health, sexual activity, and substance use, among other issues. They also were asked whether they’ve had sleep problems or had been diagnosed with a sleep disorder or insomnia.

Using data from more than 43,000 respondents, the researchers attempted to evaluate factors that predicted academic problems, including dropping a course, earning a lower course grade, and having a lower cumulative grade point average. The researchers examined those impacts for all students but focused on freshmen, because first-year performance "has such a large effect on retention rates and thus the economic stability for the institution of higher education," the researchers said. They found that sleep timing and sleep-related problems in college students were a strong predictor of academic problems, even after they controlled for other factors that might have had an impact, including clinical depression, feeling isolated, and a diagnosis of a learning disability or chronic health issue.

Students who earned "A" grades reported experiencing fewer of the following sleep issues: early awakenings, feeling sleepy during the day, going to bed early because they could not stay awake, or having trouble falling asleep. Students with worse grades tended to report more sleep issues.

Sleep problems had about the same impact on GPA as did binge drinking and marijuana use, the authors reported. In freshmen, poor sleep was an independent predictor of whether a student would drop or withdraw from a course. The authors adjusted their analysis to account for race, gender, work hours, chronic illness, and psychiatric problems such as anxiety.

Reducing sleep problems might have had a greater impact than reducing binge drinking or marijuana use, they said. For instance, improving sleep on just 1 night a week reduced the probability that a freshman drops a course by about 15%, the authors found.

Dr. Prichard and Dr. Hartmann also tried to gauge the effect that sleep disturbances in college eventually might have on the university’s ability to keep the student and the student’s future earnings potential. They determined that a sleep screening program that identified students at risk and led to treatment would be cost effective, even for the smallest universities. "Identifying and treating students with undiagnosed sleep problems early on in a student’s career economically benefits the university through increased retention and increases the students’ lifetime earning potential," they said.

But they noted that most institutions of higher learning do not pay much attention to students’ sleep habits. Rarely is there any time or money devoted to improving sleep, and if there is, it’s much less than the amount spent to address learning disabilities, substance abuse, and contagious illness, the researchers said. They encouraged a reexamination of the resources directed toward sleep quality in this population.

Dr. Prichard and Dr. Hartmann reported no conflicts. They received no outside funding for the study.

aault@frontlinemedcom.com

On Twitter @aliciaault

MINNEAPOLIS – Midlife insomnia increases the likelihood of retiring because of poor health or disability, a longitudinal cohort study among 1,590 Wisconsin state employees showed.

Previous research has established that insomniacs retire earlier than peers without this sleep disorder, according to lead researcher Lauren Hale, Ph.D., of the public health program, Stony Brook (N.Y.) University. But the reasons for retiring are unclear.

She and her colleagues analyzed data from the REST (Retirement and Sleep Trajectories Study) cohort, a mixed group of blue- and white-collar Wisconsin state employees who were followed from midlife onward and completed questionnaires probing their reasons for retiring.

Overall, 41% of the participants had insomnia at approximately 50 years of age based on their report of often or almost always experiencing at least one of four symptoms of the disorder, Dr. Hale reported at the annual meeting of the Associated Professional Sleep Societies.

As of 2013, two-thirds of the entire cohort had retired, most commonly citing reasons of wanting to do other things, being financially secure, and wanting more time to spend with family and friends.

But after the data were adjusted for covariates, insomnia was most strongly and significantly associated with retiring because of poor health or disability (P less than .001). And the more insomnia symptoms a participant reported, the higher his or her risk of retiring for this reason; those reporting three or four symptoms had approximately twice the risk of peers without insomnia.

Surprisingly, insomnia did not increase the risk of retirement because of being laid off (as might be expected if employees were frequently late to work because of sleep loss) or retirement because of needing to care for a family member (a stressor that might be expected to lead to insomnia), according to Dr. Hale.

"We confirmed our hypothesis that the leading reason that people who have insomnia symptoms in early life are retiring earlier is due to poor health or disability as they are getting older," she commented.

"Now, there is still work to be done; the temporal sequencing is not 100% clear," said Dr. Hale.

Although it appears that the insomnia is preceding poor health, which then triggers early retirement, it is also possible that the poor health comes first and gives rise to insomnia, ultimately leading to the decision to retire, she explained. And there is a third possibility. "There are of course many unmeasured health variables that we didn’t include in the models that might be preceding the insomnia at age 50 and then leading to early retirement. And of course there are a range of unmeasured factors – social, psychosocial, cultural – that could be leading to both concurrent insomnia and poor health, that lead to early retirement," she explained. "So we hope to probe into that in the future."

In an interview, session chair Dr. Nalaka S. Gooneratne of the department of medicine atthe Hospital of the University of Pennsylvania and the Presbyterian Medical Center of Philadelphia, said: "I think these findings have very important public health ramifications. It’s very important for the field of sleep to not just look at the effects of sleep on immediate disease outcomes, but also on public health factors such as retirement and quality of life for retirees, and maximizing functional status and independence for older adults.

"Some of this data is really quite intriguing, suggesting there are hitherto unappreciated links between sleep and the decisions people make later on in their life about how they want to manage their retirement and finances," he added. "I think it’s very important to fund and explore research on the links between aging and sleep, especially with the growing numbers of older adults in the population."

Dr. Hale disclosed no relevant conflicts of interest.

MINNEAPOLIS – Midlife insomnia increases the likelihood of retiring because of poor health or disability, a longitudinal cohort study among 1,590 Wisconsin state employees showed.

Previous research has established that insomniacs retire earlier than peers without this sleep disorder, according to lead researcher Lauren Hale, Ph.D., of the public health program, Stony Brook (N.Y.) University. But the reasons for retiring are unclear.

She and her colleagues analyzed data from the REST (Retirement and Sleep Trajectories Study) cohort, a mixed group of blue- and white-collar Wisconsin state employees who were followed from midlife onward and completed questionnaires probing their reasons for retiring.

Overall, 41% of the participants had insomnia at approximately 50 years of age based on their report of often or almost always experiencing at least one of four symptoms of the disorder, Dr. Hale reported at the annual meeting of the Associated Professional Sleep Societies.

As of 2013, two-thirds of the entire cohort had retired, most commonly citing reasons of wanting to do other things, being financially secure, and wanting more time to spend with family and friends.

But after the data were adjusted for covariates, insomnia was most strongly and significantly associated with retiring because of poor health or disability (P less than .001). And the more insomnia symptoms a participant reported, the higher his or her risk of retiring for this reason; those reporting three or four symptoms had approximately twice the risk of peers without insomnia.

Surprisingly, insomnia did not increase the risk of retirement because of being laid off (as might be expected if employees were frequently late to work because of sleep loss) or retirement because of needing to care for a family member (a stressor that might be expected to lead to insomnia), according to Dr. Hale.

"We confirmed our hypothesis that the leading reason that people who have insomnia symptoms in early life are retiring earlier is due to poor health or disability as they are getting older," she commented.

"Now, there is still work to be done; the temporal sequencing is not 100% clear," said Dr. Hale.

Although it appears that the insomnia is preceding poor health, which then triggers early retirement, it is also possible that the poor health comes first and gives rise to insomnia, ultimately leading to the decision to retire, she explained. And there is a third possibility. "There are of course many unmeasured health variables that we didn’t include in the models that might be preceding the insomnia at age 50 and then leading to early retirement. And of course there are a range of unmeasured factors – social, psychosocial, cultural – that could be leading to both concurrent insomnia and poor health, that lead to early retirement," she explained. "So we hope to probe into that in the future."

In an interview, session chair Dr. Nalaka S. Gooneratne of the department of medicine atthe Hospital of the University of Pennsylvania and the Presbyterian Medical Center of Philadelphia, said: "I think these findings have very important public health ramifications. It’s very important for the field of sleep to not just look at the effects of sleep on immediate disease outcomes, but also on public health factors such as retirement and quality of life for retirees, and maximizing functional status and independence for older adults.

"Some of this data is really quite intriguing, suggesting there are hitherto unappreciated links between sleep and the decisions people make later on in their life about how they want to manage their retirement and finances," he added. "I think it’s very important to fund and explore research on the links between aging and sleep, especially with the growing numbers of older adults in the population."

Dr. Hale disclosed no relevant conflicts of interest.

MINNEAPOLIS – Midlife insomnia increases the likelihood of retiring because of poor health or disability, a longitudinal cohort study among 1,590 Wisconsin state employees showed.

Previous research has established that insomniacs retire earlier than peers without this sleep disorder, according to lead researcher Lauren Hale, Ph.D., of the public health program, Stony Brook (N.Y.) University. But the reasons for retiring are unclear.

She and her colleagues analyzed data from the REST (Retirement and Sleep Trajectories Study) cohort, a mixed group of blue- and white-collar Wisconsin state employees who were followed from midlife onward and completed questionnaires probing their reasons for retiring.

Overall, 41% of the participants had insomnia at approximately 50 years of age based on their report of often or almost always experiencing at least one of four symptoms of the disorder, Dr. Hale reported at the annual meeting of the Associated Professional Sleep Societies.

As of 2013, two-thirds of the entire cohort had retired, most commonly citing reasons of wanting to do other things, being financially secure, and wanting more time to spend with family and friends.

But after the data were adjusted for covariates, insomnia was most strongly and significantly associated with retiring because of poor health or disability (P less than .001). And the more insomnia symptoms a participant reported, the higher his or her risk of retiring for this reason; those reporting three or four symptoms had approximately twice the risk of peers without insomnia.

Surprisingly, insomnia did not increase the risk of retirement because of being laid off (as might be expected if employees were frequently late to work because of sleep loss) or retirement because of needing to care for a family member (a stressor that might be expected to lead to insomnia), according to Dr. Hale.

"We confirmed our hypothesis that the leading reason that people who have insomnia symptoms in early life are retiring earlier is due to poor health or disability as they are getting older," she commented.

"Now, there is still work to be done; the temporal sequencing is not 100% clear," said Dr. Hale.

Although it appears that the insomnia is preceding poor health, which then triggers early retirement, it is also possible that the poor health comes first and gives rise to insomnia, ultimately leading to the decision to retire, she explained. And there is a third possibility. "There are of course many unmeasured health variables that we didn’t include in the models that might be preceding the insomnia at age 50 and then leading to early retirement. And of course there are a range of unmeasured factors – social, psychosocial, cultural – that could be leading to both concurrent insomnia and poor health, that lead to early retirement," she explained. "So we hope to probe into that in the future."

In an interview, session chair Dr. Nalaka S. Gooneratne of the department of medicine atthe Hospital of the University of Pennsylvania and the Presbyterian Medical Center of Philadelphia, said: "I think these findings have very important public health ramifications. It’s very important for the field of sleep to not just look at the effects of sleep on immediate disease outcomes, but also on public health factors such as retirement and quality of life for retirees, and maximizing functional status and independence for older adults.

"Some of this data is really quite intriguing, suggesting there are hitherto unappreciated links between sleep and the decisions people make later on in their life about how they want to manage their retirement and finances," he added. "I think it’s very important to fund and explore research on the links between aging and sleep, especially with the growing numbers of older adults in the population."

Dr. Hale disclosed no relevant conflicts of interest.

Cigarette smoking among high school students has dropped to 15.7% – the lowest level recorded by the Youth Risk Behavior Surveillance System, the Centers for Disease Control and Prevention announced June 12.

The report shows a decrease from the 18.1% rate found in 2011 and continues a downward trend since the peak rate of 36.4% was recorded in 1997.

"That meets the Healthy People 2020 objective of under 16%, and that’s good news," Dr. Tom Frieden, CDC director, said during a news conference today. "But we still face big challenges in reducing overall tobacco use."

©timur1970/Fotolia.com

While cigarette smoking is down, other nationwide surveys show increased use of hookah and e-cigarettes. Further, overall tobacco use (cigarettes, cigars, and smokeless tobacco) rates are at 22.4%, according to the report, also continuing a downward trend from 43.4% reported in 1997.

"While this particular report doesn’t have data on e-cigarette use among high school students, we know that use of e-cigarettes is skyrocketing, and we’re concerned about that," Dr. Frieden said. "We’re particularly concerned with e-cigarettes reglamorizing smoking traditional cigarettes and maybe making it more complicated to enforce smoke-free laws that protect all nonsmokers."

He noted that young people are highly vulnerable to social, environmental, and physical influences that encourage them to start smoking and "no kids should be exposed to advertising that glorifies the use of nicotine or be able to easily buy e-cigarettes because their sales have not been restricted."

The survey found that of teens who drive, 41% reported texting or e-mailing while driving.

Sex amongst teens is down, with 34% of respondents reporting they were sexually active (had sexual intercourse during the past 3 months prior to being surveyed) in 2013 vs. 38% in 1991. Among the sexually active, condom use declined to 59% in 2013 from 63% in 2003, after having increased in the 1990s and early 2000s.

The percentage of teens who are sexually active is "too high," Dr. Frieden said, but it is going in the right direction. However the trend in condom use "shows the need for continued efforts from parents, schools, and communities to educate and ensure that [teens] have the knowledge and skills they need to protect themselves from HIV, STDs, and teen pregnancy."

Soda consumption – defined as drinking 1 or more servings per day – declined from 34% in 2007 to 27% in 2013. But teens are spending more time in front of a computer, with high school students spending 3 or more hours per day on a PCs, laptops, tablets, or smartphones for non–school related activities, nearly doubling from 2003 (22%) to 2013 (41%).

"We are concerned by the amount of screen time. It cuts into time for physical activity," Dr. Frieden said. "It cuts into time for sleep. It cuts into time for interacting in a healthy way with friends and learning. It’s a trend that we’re noting and some of this is ... a shift from watching TV on the television to watching it on the computer screen, but it’s still a whole lot of time being inactive, and that is a concern."

Survey results are based on 13,583 usable questionnaires collected from 148 public and private schools nationwide, with surveys conducted during the spring of 2013.

gtwachtman@frontlinemedcom.com

Cigarette smoking among high school students has dropped to 15.7% – the lowest level recorded by the Youth Risk Behavior Surveillance System, the Centers for Disease Control and Prevention announced June 12.

The report shows a decrease from the 18.1% rate found in 2011 and continues a downward trend since the peak rate of 36.4% was recorded in 1997.

"That meets the Healthy People 2020 objective of under 16%, and that’s good news," Dr. Tom Frieden, CDC director, said during a news conference today. "But we still face big challenges in reducing overall tobacco use."

©timur1970/Fotolia.com

While cigarette smoking is down, other nationwide surveys show increased use of hookah and e-cigarettes. Further, overall tobacco use (cigarettes, cigars, and smokeless tobacco) rates are at 22.4%, according to the report, also continuing a downward trend from 43.4% reported in 1997.

"While this particular report doesn’t have data on e-cigarette use among high school students, we know that use of e-cigarettes is skyrocketing, and we’re concerned about that," Dr. Frieden said. "We’re particularly concerned with e-cigarettes reglamorizing smoking traditional cigarettes and maybe making it more complicated to enforce smoke-free laws that protect all nonsmokers."

He noted that young people are highly vulnerable to social, environmental, and physical influences that encourage them to start smoking and "no kids should be exposed to advertising that glorifies the use of nicotine or be able to easily buy e-cigarettes because their sales have not been restricted."

The survey found that of teens who drive, 41% reported texting or e-mailing while driving.

Sex amongst teens is down, with 34% of respondents reporting they were sexually active (had sexual intercourse during the past 3 months prior to being surveyed) in 2013 vs. 38% in 1991. Among the sexually active, condom use declined to 59% in 2013 from 63% in 2003, after having increased in the 1990s and early 2000s.

The percentage of teens who are sexually active is "too high," Dr. Frieden said, but it is going in the right direction. However the trend in condom use "shows the need for continued efforts from parents, schools, and communities to educate and ensure that [teens] have the knowledge and skills they need to protect themselves from HIV, STDs, and teen pregnancy."

Soda consumption – defined as drinking 1 or more servings per day – declined from 34% in 2007 to 27% in 2013. But teens are spending more time in front of a computer, with high school students spending 3 or more hours per day on a PCs, laptops, tablets, or smartphones for non–school related activities, nearly doubling from 2003 (22%) to 2013 (41%).

"We are concerned by the amount of screen time. It cuts into time for physical activity," Dr. Frieden said. "It cuts into time for sleep. It cuts into time for interacting in a healthy way with friends and learning. It’s a trend that we’re noting and some of this is ... a shift from watching TV on the television to watching it on the computer screen, but it’s still a whole lot of time being inactive, and that is a concern."

Survey results are based on 13,583 usable questionnaires collected from 148 public and private schools nationwide, with surveys conducted during the spring of 2013.

gtwachtman@frontlinemedcom.com

Cigarette smoking among high school students has dropped to 15.7% – the lowest level recorded by the Youth Risk Behavior Surveillance System, the Centers for Disease Control and Prevention announced June 12.

The report shows a decrease from the 18.1% rate found in 2011 and continues a downward trend since the peak rate of 36.4% was recorded in 1997.

"That meets the Healthy People 2020 objective of under 16%, and that’s good news," Dr. Tom Frieden, CDC director, said during a news conference today. "But we still face big challenges in reducing overall tobacco use."

©timur1970/Fotolia.com

While cigarette smoking is down, other nationwide surveys show increased use of hookah and e-cigarettes. Further, overall tobacco use (cigarettes, cigars, and smokeless tobacco) rates are at 22.4%, according to the report, also continuing a downward trend from 43.4% reported in 1997.

"While this particular report doesn’t have data on e-cigarette use among high school students, we know that use of e-cigarettes is skyrocketing, and we’re concerned about that," Dr. Frieden said. "We’re particularly concerned with e-cigarettes reglamorizing smoking traditional cigarettes and maybe making it more complicated to enforce smoke-free laws that protect all nonsmokers."

He noted that young people are highly vulnerable to social, environmental, and physical influences that encourage them to start smoking and "no kids should be exposed to advertising that glorifies the use of nicotine or be able to easily buy e-cigarettes because their sales have not been restricted."

The survey found that of teens who drive, 41% reported texting or e-mailing while driving.

Sex amongst teens is down, with 34% of respondents reporting they were sexually active (had sexual intercourse during the past 3 months prior to being surveyed) in 2013 vs. 38% in 1991. Among the sexually active, condom use declined to 59% in 2013 from 63% in 2003, after having increased in the 1990s and early 2000s.

The percentage of teens who are sexually active is "too high," Dr. Frieden said, but it is going in the right direction. However the trend in condom use "shows the need for continued efforts from parents, schools, and communities to educate and ensure that [teens] have the knowledge and skills they need to protect themselves from HIV, STDs, and teen pregnancy."

Soda consumption – defined as drinking 1 or more servings per day – declined from 34% in 2007 to 27% in 2013. But teens are spending more time in front of a computer, with high school students spending 3 or more hours per day on a PCs, laptops, tablets, or smartphones for non–school related activities, nearly doubling from 2003 (22%) to 2013 (41%).

"We are concerned by the amount of screen time. It cuts into time for physical activity," Dr. Frieden said. "It cuts into time for sleep. It cuts into time for interacting in a healthy way with friends and learning. It’s a trend that we’re noting and some of this is ... a shift from watching TV on the television to watching it on the computer screen, but it’s still a whole lot of time being inactive, and that is a concern."

Survey results are based on 13,583 usable questionnaires collected from 148 public and private schools nationwide, with surveys conducted during the spring of 2013.

gtwachtman@frontlinemedcom.com