Robert Finn

SAN FRANCISCO — Patients with HIV do just as well as patients without the virus when faced with bacterial community-acquired pneumonia, according to a poster presentation by Dr. Maricar Malinis at the International Conference of the American Thoracic Society.

Dr. Malinis, of the University of Louisville (Ky.), and colleagues concluded that “the decision to hospitalize a patient [with community-acquired pneumonia] should not be based on the HIV status, but rather on the severity of illness.”

The investigators conducted a large, retrospective study based on a database maintained by the Community-Acquired Pneumonia Organization (CAPO).

The CAPO database is the result of an international cohort study of patients with community-acquired pneumonia (CAP) hospitalized between 2001 and 2006.

Dr. Malinis and associates included in their analysis a total of 2,908 patients, of whom 118 (4.1%) were HIV positive.

There were no significant differences between the groups in all-cause mortality or CAP-related mortality, measured at hospital discharge.

In the unadjusted results, there were significant differences between the groups in the time to reach clinical stability and length of hospital stay.

In both measures, patients with HIV did better than patients without HIV.

But the statistical differences disappeared when the results were adjusted for significant demographic and clinical covariates.

For example, patients who had HIV were significantly younger on average than patients without the virus (40 years vs. 67 years). Also, more of the HIV-positive patients were men (74% vs. 61%) and fewer of them had a cavitary lesion (9% vs. 20%).

The investigators wrote that the results of the study suggest that, at least in the area of hospitalization, the current national guidelines for managing patients with CAP can be applied to patients who have HIV.

SAN FRANCISCO — Patients with HIV do just as well as patients without the virus when faced with bacterial community-acquired pneumonia, according to a poster presentation by Dr. Maricar Malinis at the International Conference of the American Thoracic Society.

Dr. Malinis, of the University of Louisville (Ky.), and colleagues concluded that “the decision to hospitalize a patient [with community-acquired pneumonia] should not be based on the HIV status, but rather on the severity of illness.”

The investigators conducted a large, retrospective study based on a database maintained by the Community-Acquired Pneumonia Organization (CAPO).

The CAPO database is the result of an international cohort study of patients with community-acquired pneumonia (CAP) hospitalized between 2001 and 2006.

Dr. Malinis and associates included in their analysis a total of 2,908 patients, of whom 118 (4.1%) were HIV positive.

There were no significant differences between the groups in all-cause mortality or CAP-related mortality, measured at hospital discharge.

In the unadjusted results, there were significant differences between the groups in the time to reach clinical stability and length of hospital stay.

In both measures, patients with HIV did better than patients without HIV.

But the statistical differences disappeared when the results were adjusted for significant demographic and clinical covariates.

For example, patients who had HIV were significantly younger on average than patients without the virus (40 years vs. 67 years). Also, more of the HIV-positive patients were men (74% vs. 61%) and fewer of them had a cavitary lesion (9% vs. 20%).

The investigators wrote that the results of the study suggest that, at least in the area of hospitalization, the current national guidelines for managing patients with CAP can be applied to patients who have HIV.

SAN FRANCISCO — Patients with HIV do just as well as patients without the virus when faced with bacterial community-acquired pneumonia, according to a poster presentation by Dr. Maricar Malinis at the International Conference of the American Thoracic Society.

Dr. Malinis, of the University of Louisville (Ky.), and colleagues concluded that “the decision to hospitalize a patient [with community-acquired pneumonia] should not be based on the HIV status, but rather on the severity of illness.”

The investigators conducted a large, retrospective study based on a database maintained by the Community-Acquired Pneumonia Organization (CAPO).

The CAPO database is the result of an international cohort study of patients with community-acquired pneumonia (CAP) hospitalized between 2001 and 2006.

Dr. Malinis and associates included in their analysis a total of 2,908 patients, of whom 118 (4.1%) were HIV positive.

There were no significant differences between the groups in all-cause mortality or CAP-related mortality, measured at hospital discharge.

In the unadjusted results, there were significant differences between the groups in the time to reach clinical stability and length of hospital stay.

In both measures, patients with HIV did better than patients without HIV.

But the statistical differences disappeared when the results were adjusted for significant demographic and clinical covariates.

For example, patients who had HIV were significantly younger on average than patients without the virus (40 years vs. 67 years). Also, more of the HIV-positive patients were men (74% vs. 61%) and fewer of them had a cavitary lesion (9% vs. 20%).

The investigators wrote that the results of the study suggest that, at least in the area of hospitalization, the current national guidelines for managing patients with CAP can be applied to patients who have HIV.

SAN FRANCISCO — Although inhaled human insulin has been approved by the FDA for use only in adults, it appears to be safe for use in children with type 1 diabetes, according to a poster presentation by Dr. Richard C. Ahrens at the international conference of the American Thoracic Society.

Combining the results of three studies comparing human insulin inhalation powder (Exubera) to subcutaneous insulin in 301 children aged 6–17 years, Dr. Ahrens, of the University of Iowa, and his colleagues concluded that the pulmonary safety profile of inhaled insulin in children is similar to that previously reported for adults.

The study was sponsored by Pfizer Inc., which manufactures Exubera. Two of the three investigators were Pfizer employees.

The children were initially followed for 24 weeks in the case of two of the trials, and for 12 weeks in the other trial. At the studies' conclusion, the children had the option of entering a long-term uncontrolled extension study in which all patients received inhaled insulin.

As in adults, the children using inhaled insulin showed small but consistent decreases in forced expiratory volume in 1 second (FEV1) and in diffusion capacity of the lung for carbon monoxide (DLCO). These decreases were evident at 12 and 24 weeks.

However, when the mean change from baseline in FEV1 was expressed as a percentage of that predicted, there were no significant changes over time, indicating that the children had normal lung growth while receiving inhaled-insulin therapy.

According to the investigators, pulmonary adverse events among the children were generally consistent with those seen in adults. Among the children taking inhaled insulin, 31.4% experienced cough, compared with 9.5% of the children taking subcutaneous insulin. The incidence of dyspnea was 3.3% among the children taking inhaled insulin and 0% among the children taking subcutaneous insulin.

The only serious adverse event was a case of pleural effusion, which occurred in one of the children taking inhaled insulin during the uncontrolled extension phase.

SAN FRANCISCO — Although inhaled human insulin has been approved by the FDA for use only in adults, it appears to be safe for use in children with type 1 diabetes, according to a poster presentation by Dr. Richard C. Ahrens at the international conference of the American Thoracic Society.

Combining the results of three studies comparing human insulin inhalation powder (Exubera) to subcutaneous insulin in 301 children aged 6–17 years, Dr. Ahrens, of the University of Iowa, and his colleagues concluded that the pulmonary safety profile of inhaled insulin in children is similar to that previously reported for adults.

The study was sponsored by Pfizer Inc., which manufactures Exubera. Two of the three investigators were Pfizer employees.

The children were initially followed for 24 weeks in the case of two of the trials, and for 12 weeks in the other trial. At the studies' conclusion, the children had the option of entering a long-term uncontrolled extension study in which all patients received inhaled insulin.

As in adults, the children using inhaled insulin showed small but consistent decreases in forced expiratory volume in 1 second (FEV1) and in diffusion capacity of the lung for carbon monoxide (DLCO). These decreases were evident at 12 and 24 weeks.

However, when the mean change from baseline in FEV1 was expressed as a percentage of that predicted, there were no significant changes over time, indicating that the children had normal lung growth while receiving inhaled-insulin therapy.

According to the investigators, pulmonary adverse events among the children were generally consistent with those seen in adults. Among the children taking inhaled insulin, 31.4% experienced cough, compared with 9.5% of the children taking subcutaneous insulin. The incidence of dyspnea was 3.3% among the children taking inhaled insulin and 0% among the children taking subcutaneous insulin.

The only serious adverse event was a case of pleural effusion, which occurred in one of the children taking inhaled insulin during the uncontrolled extension phase.

SAN FRANCISCO — Although inhaled human insulin has been approved by the FDA for use only in adults, it appears to be safe for use in children with type 1 diabetes, according to a poster presentation by Dr. Richard C. Ahrens at the international conference of the American Thoracic Society.

Combining the results of three studies comparing human insulin inhalation powder (Exubera) to subcutaneous insulin in 301 children aged 6–17 years, Dr. Ahrens, of the University of Iowa, and his colleagues concluded that the pulmonary safety profile of inhaled insulin in children is similar to that previously reported for adults.

The study was sponsored by Pfizer Inc., which manufactures Exubera. Two of the three investigators were Pfizer employees.

The children were initially followed for 24 weeks in the case of two of the trials, and for 12 weeks in the other trial. At the studies' conclusion, the children had the option of entering a long-term uncontrolled extension study in which all patients received inhaled insulin.

As in adults, the children using inhaled insulin showed small but consistent decreases in forced expiratory volume in 1 second (FEV1) and in diffusion capacity of the lung for carbon monoxide (DLCO). These decreases were evident at 12 and 24 weeks.

However, when the mean change from baseline in FEV1 was expressed as a percentage of that predicted, there were no significant changes over time, indicating that the children had normal lung growth while receiving inhaled-insulin therapy.

According to the investigators, pulmonary adverse events among the children were generally consistent with those seen in adults. Among the children taking inhaled insulin, 31.4% experienced cough, compared with 9.5% of the children taking subcutaneous insulin. The incidence of dyspnea was 3.3% among the children taking inhaled insulin and 0% among the children taking subcutaneous insulin.

The only serious adverse event was a case of pleural effusion, which occurred in one of the children taking inhaled insulin during the uncontrolled extension phase.

SAN FRANCISCO – A simple screening tool administered to parents helped identify a number of potentially serious drug reactions in their hospitalized children, Dr. Michael S. Leonard reported at meeting sponsored by the National Initiative for Children's Healthcare Quality.

The symptom-based questionnaire, requiring only yes/no answers, was offered 408 times and was completed 143 times. Of those, investigators judged 57 (40%) to be “suspected” adverse drug events.

On further examination by a clinical assessment team, seven (12%) of those suspicious events turned out to be actual adverse drug reactions, and six of them required treatment. Describing these results as “surprising,” Dr. Leonard of Women and Children's Hospital of Buffalo (N.Y.) said, “This is a far, far higher number than [in] many of the published studies out there.”

There are other methods of determining the true number of adverse drug events, including incident reports, chart reviews, and “trigger tools” developed by the Institute for Healthcare Improvement (www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral

Without an accurate estimate of the baseline level of adverse drug events, it's difficult to determine whether steps taken to reduce those levels are working.

The survey developed at Women and Children's Hospital of Buffalo has versions in English and Spanish. It does not ask parents to draw conclusions about whether their child is having a reaction to a drug. Instead it asks them whether they've noticed any changes in breathing, redness, swelling, rash, pain, or the child's level of activity during the prior 24 hours. A single affirmative answer to any of these questions defines a suspected adverse event to be investigated further.

The survey was administered on four medical-surgical floors during 5 consecutive days. Patients ranged from infants to adolescents who were being followed by general pediatricians or subspecialists.

Dr. Leonard suggested that this tool, or one like it, could be useful in satisfying the Joint Commission's national patient safety goal 13a, which was established in 2007. Goal 13a calls on health care providers to “define and communicate the means for patients and their families to report concerns about safety and encourage them to do so.”

This tool, or one like it, could be useful in satisfying national patient safety goal 13a. DR. LEONARD

SAN FRANCISCO – A simple screening tool administered to parents helped identify a number of potentially serious drug reactions in their hospitalized children, Dr. Michael S. Leonard reported at meeting sponsored by the National Initiative for Children's Healthcare Quality.

The symptom-based questionnaire, requiring only yes/no answers, was offered 408 times and was completed 143 times. Of those, investigators judged 57 (40%) to be “suspected” adverse drug events.

On further examination by a clinical assessment team, seven (12%) of those suspicious events turned out to be actual adverse drug reactions, and six of them required treatment. Describing these results as “surprising,” Dr. Leonard of Women and Children's Hospital of Buffalo (N.Y.) said, “This is a far, far higher number than [in] many of the published studies out there.”

There are other methods of determining the true number of adverse drug events, including incident reports, chart reviews, and “trigger tools” developed by the Institute for Healthcare Improvement (www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral

Without an accurate estimate of the baseline level of adverse drug events, it's difficult to determine whether steps taken to reduce those levels are working.

The survey developed at Women and Children's Hospital of Buffalo has versions in English and Spanish. It does not ask parents to draw conclusions about whether their child is having a reaction to a drug. Instead it asks them whether they've noticed any changes in breathing, redness, swelling, rash, pain, or the child's level of activity during the prior 24 hours. A single affirmative answer to any of these questions defines a suspected adverse event to be investigated further.

The survey was administered on four medical-surgical floors during 5 consecutive days. Patients ranged from infants to adolescents who were being followed by general pediatricians or subspecialists.

Dr. Leonard suggested that this tool, or one like it, could be useful in satisfying the Joint Commission's national patient safety goal 13a, which was established in 2007. Goal 13a calls on health care providers to “define and communicate the means for patients and their families to report concerns about safety and encourage them to do so.”

This tool, or one like it, could be useful in satisfying national patient safety goal 13a. DR. LEONARD

SAN FRANCISCO – A simple screening tool administered to parents helped identify a number of potentially serious drug reactions in their hospitalized children, Dr. Michael S. Leonard reported at meeting sponsored by the National Initiative for Children's Healthcare Quality.

The symptom-based questionnaire, requiring only yes/no answers, was offered 408 times and was completed 143 times. Of those, investigators judged 57 (40%) to be “suspected” adverse drug events.

On further examination by a clinical assessment team, seven (12%) of those suspicious events turned out to be actual adverse drug reactions, and six of them required treatment. Describing these results as “surprising,” Dr. Leonard of Women and Children's Hospital of Buffalo (N.Y.) said, “This is a far, far higher number than [in] many of the published studies out there.”

There are other methods of determining the true number of adverse drug events, including incident reports, chart reviews, and “trigger tools” developed by the Institute for Healthcare Improvement (www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral

Without an accurate estimate of the baseline level of adverse drug events, it's difficult to determine whether steps taken to reduce those levels are working.

The survey developed at Women and Children's Hospital of Buffalo has versions in English and Spanish. It does not ask parents to draw conclusions about whether their child is having a reaction to a drug. Instead it asks them whether they've noticed any changes in breathing, redness, swelling, rash, pain, or the child's level of activity during the prior 24 hours. A single affirmative answer to any of these questions defines a suspected adverse event to be investigated further.

The survey was administered on four medical-surgical floors during 5 consecutive days. Patients ranged from infants to adolescents who were being followed by general pediatricians or subspecialists.

Dr. Leonard suggested that this tool, or one like it, could be useful in satisfying the Joint Commission's national patient safety goal 13a, which was established in 2007. Goal 13a calls on health care providers to “define and communicate the means for patients and their families to report concerns about safety and encourage them to do so.”

This tool, or one like it, could be useful in satisfying national patient safety goal 13a. DR. LEONARD

SAN FRANCISCO – Patients with chronic obstructive pulmonary disease do worse when their regimens include theophylline or ipratropium, according to two poster presentations by Todd A. Lee, Pharm.D., at the International Conference of the American Thoracic Society.

In the first study, ipratropium (Atrovent) was associated with an adjusted 45% increased relative risk of death over 2.5 years, and theophylline was associated with an adjusted 23% increased relative risk of death, wrote Dr. Lee and his colleagues at Northwestern University, Chicago.

On the other hand, the use of inhaled corticosteroids was associated with an adjusted 13% decrease in the relative risk of death.

In the second study, all patients taking multidrug regimens that included theophylline had significantly higher mortality rates than did patients taking the same regimen without theophylline.

For example, the adjusted increased relative risk of death of a regimen including inhaled corticosteroids, long-acting β-agonists, and theophylline was 31% compared with a regimen including just inhaled corticosteroids and long-acting β-agonists.

In many of the regimens, the addition of theophylline also was associated with a significant increase in the rate of chronic obstructive pulmonary disease exacerbations.

Both of the studies involved a retrospective analysis of patients with chronic obstructive pulmonary disease in the Veterans Affairs health care system, Dr. Lee explained.

The first study used a random sample of 7,840 of these patients, and the second study used all 169,842 patients divided into six treatment groups based on their medication regimens.

Each of the treatment groups included at least 10,000 patients.

The results were adjusted for age, the chance that patients were receiving theophylline at baseline, and COPD exacerbations in the preceding 6 months.

The ipratropium finding is consistent with other studies that have raised concerns about the safety of this agent, the investigators wrote.

Tiotropium (Spiriva), a similar anticholinergic, has recently been introduced, the investigators noted.

Regarding theophylline, the investigators noted that their studies did not include quality of life measures or the potential benefits of theophylline on the activities of daily living.

“However,” they wrote, “in order to justify the use of theophylline in patients with COPD it would have to have substantial benefits in those areas to overcome the potential risk that may be associated with the use of this medication.”

Dr. Lee disclosed that he is the recipient of research grants from a consortium of pharmaceutical companies for investigations involving chronic obstructive pulmonary disease.

SAN FRANCISCO – Patients with chronic obstructive pulmonary disease do worse when their regimens include theophylline or ipratropium, according to two poster presentations by Todd A. Lee, Pharm.D., at the International Conference of the American Thoracic Society.

In the first study, ipratropium (Atrovent) was associated with an adjusted 45% increased relative risk of death over 2.5 years, and theophylline was associated with an adjusted 23% increased relative risk of death, wrote Dr. Lee and his colleagues at Northwestern University, Chicago.

On the other hand, the use of inhaled corticosteroids was associated with an adjusted 13% decrease in the relative risk of death.

In the second study, all patients taking multidrug regimens that included theophylline had significantly higher mortality rates than did patients taking the same regimen without theophylline.

For example, the adjusted increased relative risk of death of a regimen including inhaled corticosteroids, long-acting β-agonists, and theophylline was 31% compared with a regimen including just inhaled corticosteroids and long-acting β-agonists.

In many of the regimens, the addition of theophylline also was associated with a significant increase in the rate of chronic obstructive pulmonary disease exacerbations.

Both of the studies involved a retrospective analysis of patients with chronic obstructive pulmonary disease in the Veterans Affairs health care system, Dr. Lee explained.

The first study used a random sample of 7,840 of these patients, and the second study used all 169,842 patients divided into six treatment groups based on their medication regimens.

Each of the treatment groups included at least 10,000 patients.

The results were adjusted for age, the chance that patients were receiving theophylline at baseline, and COPD exacerbations in the preceding 6 months.

The ipratropium finding is consistent with other studies that have raised concerns about the safety of this agent, the investigators wrote.

Tiotropium (Spiriva), a similar anticholinergic, has recently been introduced, the investigators noted.

Regarding theophylline, the investigators noted that their studies did not include quality of life measures or the potential benefits of theophylline on the activities of daily living.

“However,” they wrote, “in order to justify the use of theophylline in patients with COPD it would have to have substantial benefits in those areas to overcome the potential risk that may be associated with the use of this medication.”

Dr. Lee disclosed that he is the recipient of research grants from a consortium of pharmaceutical companies for investigations involving chronic obstructive pulmonary disease.

SAN FRANCISCO – Patients with chronic obstructive pulmonary disease do worse when their regimens include theophylline or ipratropium, according to two poster presentations by Todd A. Lee, Pharm.D., at the International Conference of the American Thoracic Society.

In the first study, ipratropium (Atrovent) was associated with an adjusted 45% increased relative risk of death over 2.5 years, and theophylline was associated with an adjusted 23% increased relative risk of death, wrote Dr. Lee and his colleagues at Northwestern University, Chicago.

On the other hand, the use of inhaled corticosteroids was associated with an adjusted 13% decrease in the relative risk of death.

In the second study, all patients taking multidrug regimens that included theophylline had significantly higher mortality rates than did patients taking the same regimen without theophylline.

For example, the adjusted increased relative risk of death of a regimen including inhaled corticosteroids, long-acting β-agonists, and theophylline was 31% compared with a regimen including just inhaled corticosteroids and long-acting β-agonists.

In many of the regimens, the addition of theophylline also was associated with a significant increase in the rate of chronic obstructive pulmonary disease exacerbations.

Both of the studies involved a retrospective analysis of patients with chronic obstructive pulmonary disease in the Veterans Affairs health care system, Dr. Lee explained.

The first study used a random sample of 7,840 of these patients, and the second study used all 169,842 patients divided into six treatment groups based on their medication regimens.

Each of the treatment groups included at least 10,000 patients.

The results were adjusted for age, the chance that patients were receiving theophylline at baseline, and COPD exacerbations in the preceding 6 months.

The ipratropium finding is consistent with other studies that have raised concerns about the safety of this agent, the investigators wrote.

Tiotropium (Spiriva), a similar anticholinergic, has recently been introduced, the investigators noted.

Regarding theophylline, the investigators noted that their studies did not include quality of life measures or the potential benefits of theophylline on the activities of daily living.

“However,” they wrote, “in order to justify the use of theophylline in patients with COPD it would have to have substantial benefits in those areas to overcome the potential risk that may be associated with the use of this medication.”

Dr. Lee disclosed that he is the recipient of research grants from a consortium of pharmaceutical companies for investigations involving chronic obstructive pulmonary disease.

SAN FRANCISCO – Pregnant women who have obstructive sleep apnea have a 2.3-fold increased risk of gestational diabetes and a 4.2-fold increased risk of pregnancy-induced hypertension, compared with women without the sleep disorder, according to a poster presentation at the International Conference of the American Thoracic Society.

Previous research has suggested that obstructive sleep apnea (OSA) may induce systemic hypertension and diabetes mellitus in the general population, but the connection was much less clear in pregnant women, investigator Dr. Michael S. Nolledo of the Robert Wood Johnson Medical School, Princeton, N.J., said in a press briefing.

“A lot of times for patients who are pregnant and for ob.gyns., sleep-disordered breathing is not on the radar screen,” he said. When a woman who's pregnant goes to see her obstetrician, the physician asks a zillion things but almost never inquires about risk factors for sleep apnea.

Dr. Nolledo suggested that physicians dealing with women with gestational diabetes or pregnancy-induced hypertension (PIH) should inquire about sleep-disordered breathing, especially because OSA is so simple to treat with continuous positive airway pressure (CPAP).

“It may be a condition that you need treatment for just for the time you're carrying your baby,” he said. “Once you deliver, the sleep apnea may resolve.”

Dr. Nolledo acknowledged, however, that his study contains no direct evidence that treating sleep apnea will improve PIH or gestational diabetes.The study relied on data from the 2003 National Inpatient Sample, sponsored by the Agency for Healthcare Research and Quality. This large database includes all inpatient records from a sample of about 20% of U.S. community short-stay hospitals and provides weights to calculate national estimates.

Using this database, the investigators calculated that there were 3,979,840 deliveries in the United States in 2003, of which 167,227 were complicated by gestational diabetes and 300,902 were complicated by PIH. The overall rate of sleep apnea for these women was 1.14/10,000–but that rate was 4.01/10,000 among women with gestational diabetes and 5.52/10,000 among women with PIH.

In an interview, Dr. Nolledo acknowledged that the overall rate of OSA recorded in the database is much lower than the 2%–4% rate of OSA estimated for the general population. He attributed this in part to the failure of physicians to ask their pregnant patients about sleep-disordered breathing.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO – Pregnant women who have obstructive sleep apnea have a 2.3-fold increased risk of gestational diabetes and a 4.2-fold increased risk of pregnancy-induced hypertension, compared with women without the sleep disorder, according to a poster presentation at the International Conference of the American Thoracic Society.

Previous research has suggested that obstructive sleep apnea (OSA) may induce systemic hypertension and diabetes mellitus in the general population, but the connection was much less clear in pregnant women, investigator Dr. Michael S. Nolledo of the Robert Wood Johnson Medical School, Princeton, N.J., said in a press briefing.

“A lot of times for patients who are pregnant and for ob.gyns., sleep-disordered breathing is not on the radar screen,” he said. When a woman who's pregnant goes to see her obstetrician, the physician asks a zillion things but almost never inquires about risk factors for sleep apnea.

Dr. Nolledo suggested that physicians dealing with women with gestational diabetes or pregnancy-induced hypertension (PIH) should inquire about sleep-disordered breathing, especially because OSA is so simple to treat with continuous positive airway pressure (CPAP).

“It may be a condition that you need treatment for just for the time you're carrying your baby,” he said. “Once you deliver, the sleep apnea may resolve.”

Dr. Nolledo acknowledged, however, that his study contains no direct evidence that treating sleep apnea will improve PIH or gestational diabetes.The study relied on data from the 2003 National Inpatient Sample, sponsored by the Agency for Healthcare Research and Quality. This large database includes all inpatient records from a sample of about 20% of U.S. community short-stay hospitals and provides weights to calculate national estimates.

Using this database, the investigators calculated that there were 3,979,840 deliveries in the United States in 2003, of which 167,227 were complicated by gestational diabetes and 300,902 were complicated by PIH. The overall rate of sleep apnea for these women was 1.14/10,000–but that rate was 4.01/10,000 among women with gestational diabetes and 5.52/10,000 among women with PIH.

In an interview, Dr. Nolledo acknowledged that the overall rate of OSA recorded in the database is much lower than the 2%–4% rate of OSA estimated for the general population. He attributed this in part to the failure of physicians to ask their pregnant patients about sleep-disordered breathing.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO – Pregnant women who have obstructive sleep apnea have a 2.3-fold increased risk of gestational diabetes and a 4.2-fold increased risk of pregnancy-induced hypertension, compared with women without the sleep disorder, according to a poster presentation at the International Conference of the American Thoracic Society.

Previous research has suggested that obstructive sleep apnea (OSA) may induce systemic hypertension and diabetes mellitus in the general population, but the connection was much less clear in pregnant women, investigator Dr. Michael S. Nolledo of the Robert Wood Johnson Medical School, Princeton, N.J., said in a press briefing.

“A lot of times for patients who are pregnant and for ob.gyns., sleep-disordered breathing is not on the radar screen,” he said. When a woman who's pregnant goes to see her obstetrician, the physician asks a zillion things but almost never inquires about risk factors for sleep apnea.

Dr. Nolledo suggested that physicians dealing with women with gestational diabetes or pregnancy-induced hypertension (PIH) should inquire about sleep-disordered breathing, especially because OSA is so simple to treat with continuous positive airway pressure (CPAP).

“It may be a condition that you need treatment for just for the time you're carrying your baby,” he said. “Once you deliver, the sleep apnea may resolve.”

Dr. Nolledo acknowledged, however, that his study contains no direct evidence that treating sleep apnea will improve PIH or gestational diabetes.The study relied on data from the 2003 National Inpatient Sample, sponsored by the Agency for Healthcare Research and Quality. This large database includes all inpatient records from a sample of about 20% of U.S. community short-stay hospitals and provides weights to calculate national estimates.

Using this database, the investigators calculated that there were 3,979,840 deliveries in the United States in 2003, of which 167,227 were complicated by gestational diabetes and 300,902 were complicated by PIH. The overall rate of sleep apnea for these women was 1.14/10,000–but that rate was 4.01/10,000 among women with gestational diabetes and 5.52/10,000 among women with PIH.

In an interview, Dr. Nolledo acknowledged that the overall rate of OSA recorded in the database is much lower than the 2%–4% rate of OSA estimated for the general population. He attributed this in part to the failure of physicians to ask their pregnant patients about sleep-disordered breathing.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO – A panel of 70 transplant professionals has published a consensus document on the psychosocial evaluation of living unrelated kidney donors, Dr. Francis L. Delmonico reported at the American Transplant Congress.

The guidelines are intended to help transplant centers exclude donors who are unsuitable for a variety of nonmedical reasons, such as coercion, unrealistic expectations, and psychological disorders. “The objective was to assess the characteristics of a prospective unrelated donor that might either increase the risk or serve as a protective factor against a poor donor psychosocial outcome,” said Dr. Delmonico, professor of surgery at Harvard Medical School, Boston.

Describing the current situation as “an era of changing donor-recipient relationships,” Dr. Delmonico said that the guidelines will likely allow transplant centers to be “somewhat more secure in proceeding ahead in very careful assessment and within an ethical framework.”

The new guidelines are the result of a meeting convened in May 2006 by the United Network for Organ Sharing in collaboration with the American Society of Transplant Surgeons and the American Society of Transplantation. That panel recommended several revisions to earlier consensus statements on living donors and offered a new list of required components for the psychosocial evaluation of living unrelated kidney donors. (See box.)

The new document notes that biologically unrelated donors constitute 35% of the living kidney donors in the United States. Among living donors, the percentage without a biologic or close emotional relationship to the recipient rose from 6.5% to 23% between 1996 and 2006 (Am. J. Transplant. 2007;7:1047–54).

Some of the factors that would tend to increase the risks of living unrelated kidney donation are significant psychiatric symptoms or disorders; substance abuse or dependence; a lack of health insurance; a limited capacity to understand risks; motives reflecting a desire for recognition; a subordinate relationship to the patient, such as employee or employer; or an expectation of secondary gain.

Several other factors would tend to decrease the risk, including financial resources that could cover unexpected costs, realistic expectations about the donation experience, little or no ambivalence, a history of medical altruism, an absence of recent significant life stressors, and support from family for the donation.

In its changes to earlier consensus statements, the panel noted that novel forms of donor solicitation, such as Internet sites, point to an increased need to ascertain that the prospective donor was not pressured and does not expect financial gain.

This meeting was cosponsored by the American Society of Transplant Surgeons and the American Society of Transplantation.

Assessing Unrelated Prospective Donors

The following are the required components of psychosocial evaluations for living unrelated kidney donors, as agreed to by a panel convened by the United Network for Organ Sharing, the American Society of Transplant Surgeons, and the American Society of Transplantation:

▸ History and current status. Assess factors such as the prospective donor's educational level, employment, legal offense history, and citizenship.

▸ Capacity. Ensure that the prospective donor's cognitive status and capacity to comprehend information are not compromised.

▸ Psychological status. Determine whether the prospective donor has ever had any psychiatric disorders.

▸ Relationship with the transplant candidate. How close is the relationship, and would the transplant impose expectations or perceived obligations?

▸ Motivation. Determine the voluntariness of the proposed donation. Is it consistent with past behaviors and values? Is it free of coercion, inducements, ambivalence, impulsivity, and ulterior motives?

▸ Donor knowledge, understanding, and preparation. Does the prospective donor understand potential short- and long-term risks, including recuperation time and financial ramifications?

▸ Social support. Evaluate familial, social, and employer support networks available to the prospective donor.

▸ Financial suitability. Determine whether the prospective donor is financially stable and has resources available to cover expected and unexpected donation-related expenses.

Source: Am. J. Transplant. 2007;7:1047–54.

SAN FRANCISCO – A panel of 70 transplant professionals has published a consensus document on the psychosocial evaluation of living unrelated kidney donors, Dr. Francis L. Delmonico reported at the American Transplant Congress.

The guidelines are intended to help transplant centers exclude donors who are unsuitable for a variety of nonmedical reasons, such as coercion, unrealistic expectations, and psychological disorders. “The objective was to assess the characteristics of a prospective unrelated donor that might either increase the risk or serve as a protective factor against a poor donor psychosocial outcome,” said Dr. Delmonico, professor of surgery at Harvard Medical School, Boston.

Describing the current situation as “an era of changing donor-recipient relationships,” Dr. Delmonico said that the guidelines will likely allow transplant centers to be “somewhat more secure in proceeding ahead in very careful assessment and within an ethical framework.”

The new guidelines are the result of a meeting convened in May 2006 by the United Network for Organ Sharing in collaboration with the American Society of Transplant Surgeons and the American Society of Transplantation. That panel recommended several revisions to earlier consensus statements on living donors and offered a new list of required components for the psychosocial evaluation of living unrelated kidney donors. (See box.)

The new document notes that biologically unrelated donors constitute 35% of the living kidney donors in the United States. Among living donors, the percentage without a biologic or close emotional relationship to the recipient rose from 6.5% to 23% between 1996 and 2006 (Am. J. Transplant. 2007;7:1047–54).

Some of the factors that would tend to increase the risks of living unrelated kidney donation are significant psychiatric symptoms or disorders; substance abuse or dependence; a lack of health insurance; a limited capacity to understand risks; motives reflecting a desire for recognition; a subordinate relationship to the patient, such as employee or employer; or an expectation of secondary gain.

Several other factors would tend to decrease the risk, including financial resources that could cover unexpected costs, realistic expectations about the donation experience, little or no ambivalence, a history of medical altruism, an absence of recent significant life stressors, and support from family for the donation.

In its changes to earlier consensus statements, the panel noted that novel forms of donor solicitation, such as Internet sites, point to an increased need to ascertain that the prospective donor was not pressured and does not expect financial gain.

This meeting was cosponsored by the American Society of Transplant Surgeons and the American Society of Transplantation.

Assessing Unrelated Prospective Donors

The following are the required components of psychosocial evaluations for living unrelated kidney donors, as agreed to by a panel convened by the United Network for Organ Sharing, the American Society of Transplant Surgeons, and the American Society of Transplantation:

▸ History and current status. Assess factors such as the prospective donor's educational level, employment, legal offense history, and citizenship.

▸ Capacity. Ensure that the prospective donor's cognitive status and capacity to comprehend information are not compromised.

▸ Psychological status. Determine whether the prospective donor has ever had any psychiatric disorders.

▸ Relationship with the transplant candidate. How close is the relationship, and would the transplant impose expectations or perceived obligations?

▸ Motivation. Determine the voluntariness of the proposed donation. Is it consistent with past behaviors and values? Is it free of coercion, inducements, ambivalence, impulsivity, and ulterior motives?

▸ Donor knowledge, understanding, and preparation. Does the prospective donor understand potential short- and long-term risks, including recuperation time and financial ramifications?

▸ Social support. Evaluate familial, social, and employer support networks available to the prospective donor.

▸ Financial suitability. Determine whether the prospective donor is financially stable and has resources available to cover expected and unexpected donation-related expenses.

Source: Am. J. Transplant. 2007;7:1047–54.

SAN FRANCISCO – A panel of 70 transplant professionals has published a consensus document on the psychosocial evaluation of living unrelated kidney donors, Dr. Francis L. Delmonico reported at the American Transplant Congress.

The guidelines are intended to help transplant centers exclude donors who are unsuitable for a variety of nonmedical reasons, such as coercion, unrealistic expectations, and psychological disorders. “The objective was to assess the characteristics of a prospective unrelated donor that might either increase the risk or serve as a protective factor against a poor donor psychosocial outcome,” said Dr. Delmonico, professor of surgery at Harvard Medical School, Boston.

Describing the current situation as “an era of changing donor-recipient relationships,” Dr. Delmonico said that the guidelines will likely allow transplant centers to be “somewhat more secure in proceeding ahead in very careful assessment and within an ethical framework.”

The new guidelines are the result of a meeting convened in May 2006 by the United Network for Organ Sharing in collaboration with the American Society of Transplant Surgeons and the American Society of Transplantation. That panel recommended several revisions to earlier consensus statements on living donors and offered a new list of required components for the psychosocial evaluation of living unrelated kidney donors. (See box.)

The new document notes that biologically unrelated donors constitute 35% of the living kidney donors in the United States. Among living donors, the percentage without a biologic or close emotional relationship to the recipient rose from 6.5% to 23% between 1996 and 2006 (Am. J. Transplant. 2007;7:1047–54).

Some of the factors that would tend to increase the risks of living unrelated kidney donation are significant psychiatric symptoms or disorders; substance abuse or dependence; a lack of health insurance; a limited capacity to understand risks; motives reflecting a desire for recognition; a subordinate relationship to the patient, such as employee or employer; or an expectation of secondary gain.

Several other factors would tend to decrease the risk, including financial resources that could cover unexpected costs, realistic expectations about the donation experience, little or no ambivalence, a history of medical altruism, an absence of recent significant life stressors, and support from family for the donation.

In its changes to earlier consensus statements, the panel noted that novel forms of donor solicitation, such as Internet sites, point to an increased need to ascertain that the prospective donor was not pressured and does not expect financial gain.

This meeting was cosponsored by the American Society of Transplant Surgeons and the American Society of Transplantation.

Assessing Unrelated Prospective Donors

The following are the required components of psychosocial evaluations for living unrelated kidney donors, as agreed to by a panel convened by the United Network for Organ Sharing, the American Society of Transplant Surgeons, and the American Society of Transplantation:

▸ History and current status. Assess factors such as the prospective donor's educational level, employment, legal offense history, and citizenship.

▸ Capacity. Ensure that the prospective donor's cognitive status and capacity to comprehend information are not compromised.

▸ Psychological status. Determine whether the prospective donor has ever had any psychiatric disorders.

▸ Relationship with the transplant candidate. How close is the relationship, and would the transplant impose expectations or perceived obligations?

▸ Motivation. Determine the voluntariness of the proposed donation. Is it consistent with past behaviors and values? Is it free of coercion, inducements, ambivalence, impulsivity, and ulterior motives?

▸ Donor knowledge, understanding, and preparation. Does the prospective donor understand potential short- and long-term risks, including recuperation time and financial ramifications?

▸ Social support. Evaluate familial, social, and employer support networks available to the prospective donor.

▸ Financial suitability. Determine whether the prospective donor is financially stable and has resources available to cover expected and unexpected donation-related expenses.

Source: Am. J. Transplant. 2007;7:1047–54.

A bivalent vaccine for human papillomavirus manufactured by GlaxoSmithKline has shown greater than 90% efficacy against high-grade cervical intraepithelial neoplasia, according to interim results from a large, randomized controlled trial published online in the Lancet.

The study, led by Dr. Jorma Paavonen and colleagues, is called the Papilloma Trial to Prevent Cervical Cancer in Young Adults (PATRICIA), and involves 18,644 women, aged 15–25 years, from 14 countries in Europe, Asia, and North America.

The participants were randomly assigned to receive three injections of the human papillomavirus (HPV) vaccine or a hepatitis A vaccine at months 0, 1, and 6 (Lancet 2007; DOI:10.1016/S0140-6736[07]60946-5).

The study was sponsored by GlaxoSmithKline. Several study investigators were employees of the company, and others, including Dr. Paavonen of the University of Helsinki received consulting and lecture fees from the pharmaceutical firm.

The vaccine, Cervarix, has not yet been approved by the Food and Drug Administration. If it is approved, it will be competing against Merck's already released HPV vaccine, Gardasil. Cervarix is a bivalent vaccine, active against HPV types 16 and 18, which account for 70% of all cases of cervical cancer. Gardasil is a quadrivalent vaccine, active against HPV types 6 and 11 (the cause of 90% of genital warts) in addition to types 16 and 18.

In the current study, only 2 of the 9,319 women receiving Cervarix developed cervical intraepithelial neoplasia (CIN) of grade 2 or 3 and related to HPV 16 or 18, compared with 21 of the 9,325 women in the control group. This translates into an efficacy of 90%.

The vaccine also showed 89% efficacy against grade 1 or higher CIN.

Virtually all the women receiving the HPV vaccine (99.5%) had developed antibodies against HPV 16 and 18 after the second of the three injections.

In an accompanying editorial, Dr. Jessica A. Kahn of the University of Cincinnati and Dr. Robert D. Burk of the Albert Einstein College of Medicine, New York, described these results as “encouraging,” while sounding a note of caution (Lancet 2007; DOI:10.1016/S0140-6736[07]60947-7).

They noted that the follow-up time was only about 15 months, which is short compared with the several decades over which cervical cancer often evolves. The enrollment criteria in the trial were relatively narrow, so it's unknown whether seroconversion rates, antibody titers, and efficacy rates will be as high when the vaccine is distributed to a wider population.

Dr. Kahn and Dr. Burk also emphasized that the vaccine was not without side effects. Although generally well tolerated and safe, the HPV vaccine caused significantly more local adverse events such as pain, redness, and swelling, than did the hepatitis A vaccine. Risks of general adverse events, including arthralgia, fatigue, and myalgia, also were significantly higher in the HPV group.

Dr. Kahn and Dr. Burk stressed the need for the vaccine to be made available in less-developed regions of the world, where cervical cancer makes the largest contribution to years of life lost to cancer. “Poverty is strongly associated with high-risk HPV infection and cervical cancer,” they wrote. “If those who live in poverty cannot access highly effective interventions such as HPV vaccines, disparities could worsen dramatically.”

A bivalent vaccine for human papillomavirus manufactured by GlaxoSmithKline has shown greater than 90% efficacy against high-grade cervical intraepithelial neoplasia, according to interim results from a large, randomized controlled trial published online in the Lancet.

The study, led by Dr. Jorma Paavonen and colleagues, is called the Papilloma Trial to Prevent Cervical Cancer in Young Adults (PATRICIA), and involves 18,644 women, aged 15–25 years, from 14 countries in Europe, Asia, and North America.

The participants were randomly assigned to receive three injections of the human papillomavirus (HPV) vaccine or a hepatitis A vaccine at months 0, 1, and 6 (Lancet 2007; DOI:10.1016/S0140-6736[07]60946-5).

The study was sponsored by GlaxoSmithKline. Several study investigators were employees of the company, and others, including Dr. Paavonen of the University of Helsinki received consulting and lecture fees from the pharmaceutical firm.

The vaccine, Cervarix, has not yet been approved by the Food and Drug Administration. If it is approved, it will be competing against Merck's already released HPV vaccine, Gardasil. Cervarix is a bivalent vaccine, active against HPV types 16 and 18, which account for 70% of all cases of cervical cancer. Gardasil is a quadrivalent vaccine, active against HPV types 6 and 11 (the cause of 90% of genital warts) in addition to types 16 and 18.

In the current study, only 2 of the 9,319 women receiving Cervarix developed cervical intraepithelial neoplasia (CIN) of grade 2 or 3 and related to HPV 16 or 18, compared with 21 of the 9,325 women in the control group. This translates into an efficacy of 90%.

The vaccine also showed 89% efficacy against grade 1 or higher CIN.

Virtually all the women receiving the HPV vaccine (99.5%) had developed antibodies against HPV 16 and 18 after the second of the three injections.

In an accompanying editorial, Dr. Jessica A. Kahn of the University of Cincinnati and Dr. Robert D. Burk of the Albert Einstein College of Medicine, New York, described these results as “encouraging,” while sounding a note of caution (Lancet 2007; DOI:10.1016/S0140-6736[07]60947-7).

They noted that the follow-up time was only about 15 months, which is short compared with the several decades over which cervical cancer often evolves. The enrollment criteria in the trial were relatively narrow, so it's unknown whether seroconversion rates, antibody titers, and efficacy rates will be as high when the vaccine is distributed to a wider population.

Dr. Kahn and Dr. Burk also emphasized that the vaccine was not without side effects. Although generally well tolerated and safe, the HPV vaccine caused significantly more local adverse events such as pain, redness, and swelling, than did the hepatitis A vaccine. Risks of general adverse events, including arthralgia, fatigue, and myalgia, also were significantly higher in the HPV group.

Dr. Kahn and Dr. Burk stressed the need for the vaccine to be made available in less-developed regions of the world, where cervical cancer makes the largest contribution to years of life lost to cancer. “Poverty is strongly associated with high-risk HPV infection and cervical cancer,” they wrote. “If those who live in poverty cannot access highly effective interventions such as HPV vaccines, disparities could worsen dramatically.”

A bivalent vaccine for human papillomavirus manufactured by GlaxoSmithKline has shown greater than 90% efficacy against high-grade cervical intraepithelial neoplasia, according to interim results from a large, randomized controlled trial published online in the Lancet.

The study, led by Dr. Jorma Paavonen and colleagues, is called the Papilloma Trial to Prevent Cervical Cancer in Young Adults (PATRICIA), and involves 18,644 women, aged 15–25 years, from 14 countries in Europe, Asia, and North America.

The participants were randomly assigned to receive three injections of the human papillomavirus (HPV) vaccine or a hepatitis A vaccine at months 0, 1, and 6 (Lancet 2007; DOI:10.1016/S0140-6736[07]60946-5).

The study was sponsored by GlaxoSmithKline. Several study investigators were employees of the company, and others, including Dr. Paavonen of the University of Helsinki received consulting and lecture fees from the pharmaceutical firm.

The vaccine, Cervarix, has not yet been approved by the Food and Drug Administration. If it is approved, it will be competing against Merck's already released HPV vaccine, Gardasil. Cervarix is a bivalent vaccine, active against HPV types 16 and 18, which account for 70% of all cases of cervical cancer. Gardasil is a quadrivalent vaccine, active against HPV types 6 and 11 (the cause of 90% of genital warts) in addition to types 16 and 18.

In the current study, only 2 of the 9,319 women receiving Cervarix developed cervical intraepithelial neoplasia (CIN) of grade 2 or 3 and related to HPV 16 or 18, compared with 21 of the 9,325 women in the control group. This translates into an efficacy of 90%.

The vaccine also showed 89% efficacy against grade 1 or higher CIN.

Virtually all the women receiving the HPV vaccine (99.5%) had developed antibodies against HPV 16 and 18 after the second of the three injections.

In an accompanying editorial, Dr. Jessica A. Kahn of the University of Cincinnati and Dr. Robert D. Burk of the Albert Einstein College of Medicine, New York, described these results as “encouraging,” while sounding a note of caution (Lancet 2007; DOI:10.1016/S0140-6736[07]60947-7).

They noted that the follow-up time was only about 15 months, which is short compared with the several decades over which cervical cancer often evolves. The enrollment criteria in the trial were relatively narrow, so it's unknown whether seroconversion rates, antibody titers, and efficacy rates will be as high when the vaccine is distributed to a wider population.

Dr. Kahn and Dr. Burk also emphasized that the vaccine was not without side effects. Although generally well tolerated and safe, the HPV vaccine caused significantly more local adverse events such as pain, redness, and swelling, than did the hepatitis A vaccine. Risks of general adverse events, including arthralgia, fatigue, and myalgia, also were significantly higher in the HPV group.

Dr. Kahn and Dr. Burk stressed the need for the vaccine to be made available in less-developed regions of the world, where cervical cancer makes the largest contribution to years of life lost to cancer. “Poverty is strongly associated with high-risk HPV infection and cervical cancer,” they wrote. “If those who live in poverty cannot access highly effective interventions such as HPV vaccines, disparities could worsen dramatically.”

SAN FRANCISCO — Pregnant women who have obstructive sleep apnea have a 2.3-fold increased risk of gestational diabetes and a 4.2-fold increased risk of pregnancy-induced hypertension, compared with women without the sleep disorder, according to a poster presentation at the International Conference of the American Thoracic Society.

Previous research has suggested that obstructive sleep apnea (OSA) may induce systemic hypertension and diabetes mellitus in the general population, but the connection was much less clear in pregnant women, investigator Dr. Michael S. Nolledo of the Robert Wood Johnson Medical School, Princeton, N.J., said in a press briefing.

“A lot of times for patients who are pregnant and for ob.gyns., sleep-disordered breathing is not on the radar screen,” he said. When a woman who is pregnant goes to see her obstetrician, the physician asks a zillion things but almost never inquires about risk factors for sleep apnea.

Dr. Nolledo suggested that physicians dealing with women with gestational diabetes or pregnancy-induced hypertension (PIH) should inquire about sleep-disordered breathing, especially because OSA is so simple to treat with continuous positive airway pressure (CPAP).

“It may be a condition that you need treatment for just for the time you're carrying your baby,” Dr. Nolledo commented. “Once you deliver, the sleep apnea may resolve.”

Dr. Nolledo acknowledged, however, that his study contains no direct evidence that treating sleep apnea will improve PIH or gestational diabetes.

The study relied on data from the 2003 National Inpatient Sample, sponsored by the Agency for Healthcare Research and Quality.

This large database includes all inpatient records from a sample of about 20% of U.S. community short-stay hospitals and provides weights to calculate national estimates.

Using this database, the investigators calculated that there were 3,979,840 deliveries in the United States in 2003, of which 167,227 were complicated by gestational diabetes and 300,902 were complicated by PIH.

The overall rate of sleep apnea for these women was 1.14/10,000—but that rate was 4.01/10,000 among women with gestational diabetes and 5.52/10,000 among women with PIH.

When controlled for age and race, women with sleep apnea were 3.5 times more likely to develop gestational diabetes; when controlled for obesity, the odds ratio was still 2.3.

Similarly, the odds ratio for PIH in women with sleep apnea was 6.6 when controlling for age and race, and 4.2 after also controlling for obesity.

In an interview, Dr. Nolledo acknowledged that the overall rate of OSA recorded in the database—just over 1/10,000, or 0.01%—is much lower than the 2%–4% rate of OSA estimated for the general population.

He attributed this in part to the fact that physicians often don't think to ask their pregnant patients about sleep-disordered breathing.

An alternative explanation for the results is that physicians may ask about sleep-disordered breathing more frequently when faced with patients with gestational diabetes or PIH, he said, and that this alone can account for the apparent increases in risk.

SAN FRANCISCO — Pregnant women who have obstructive sleep apnea have a 2.3-fold increased risk of gestational diabetes and a 4.2-fold increased risk of pregnancy-induced hypertension, compared with women without the sleep disorder, according to a poster presentation at the International Conference of the American Thoracic Society.

Previous research has suggested that obstructive sleep apnea (OSA) may induce systemic hypertension and diabetes mellitus in the general population, but the connection was much less clear in pregnant women, investigator Dr. Michael S. Nolledo of the Robert Wood Johnson Medical School, Princeton, N.J., said in a press briefing.

“A lot of times for patients who are pregnant and for ob.gyns., sleep-disordered breathing is not on the radar screen,” he said. When a woman who is pregnant goes to see her obstetrician, the physician asks a zillion things but almost never inquires about risk factors for sleep apnea.

Dr. Nolledo suggested that physicians dealing with women with gestational diabetes or pregnancy-induced hypertension (PIH) should inquire about sleep-disordered breathing, especially because OSA is so simple to treat with continuous positive airway pressure (CPAP).

“It may be a condition that you need treatment for just for the time you're carrying your baby,” Dr. Nolledo commented. “Once you deliver, the sleep apnea may resolve.”

Dr. Nolledo acknowledged, however, that his study contains no direct evidence that treating sleep apnea will improve PIH or gestational diabetes.

The study relied on data from the 2003 National Inpatient Sample, sponsored by the Agency for Healthcare Research and Quality.

This large database includes all inpatient records from a sample of about 20% of U.S. community short-stay hospitals and provides weights to calculate national estimates.

Using this database, the investigators calculated that there were 3,979,840 deliveries in the United States in 2003, of which 167,227 were complicated by gestational diabetes and 300,902 were complicated by PIH.

The overall rate of sleep apnea for these women was 1.14/10,000—but that rate was 4.01/10,000 among women with gestational diabetes and 5.52/10,000 among women with PIH.

When controlled for age and race, women with sleep apnea were 3.5 times more likely to develop gestational diabetes; when controlled for obesity, the odds ratio was still 2.3.

Similarly, the odds ratio for PIH in women with sleep apnea was 6.6 when controlling for age and race, and 4.2 after also controlling for obesity.

In an interview, Dr. Nolledo acknowledged that the overall rate of OSA recorded in the database—just over 1/10,000, or 0.01%—is much lower than the 2%–4% rate of OSA estimated for the general population.

He attributed this in part to the fact that physicians often don't think to ask their pregnant patients about sleep-disordered breathing.

An alternative explanation for the results is that physicians may ask about sleep-disordered breathing more frequently when faced with patients with gestational diabetes or PIH, he said, and that this alone can account for the apparent increases in risk.

SAN FRANCISCO — Pregnant women who have obstructive sleep apnea have a 2.3-fold increased risk of gestational diabetes and a 4.2-fold increased risk of pregnancy-induced hypertension, compared with women without the sleep disorder, according to a poster presentation at the International Conference of the American Thoracic Society.

Previous research has suggested that obstructive sleep apnea (OSA) may induce systemic hypertension and diabetes mellitus in the general population, but the connection was much less clear in pregnant women, investigator Dr. Michael S. Nolledo of the Robert Wood Johnson Medical School, Princeton, N.J., said in a press briefing.

“A lot of times for patients who are pregnant and for ob.gyns., sleep-disordered breathing is not on the radar screen,” he said. When a woman who is pregnant goes to see her obstetrician, the physician asks a zillion things but almost never inquires about risk factors for sleep apnea.

Dr. Nolledo suggested that physicians dealing with women with gestational diabetes or pregnancy-induced hypertension (PIH) should inquire about sleep-disordered breathing, especially because OSA is so simple to treat with continuous positive airway pressure (CPAP).

“It may be a condition that you need treatment for just for the time you're carrying your baby,” Dr. Nolledo commented. “Once you deliver, the sleep apnea may resolve.”

Dr. Nolledo acknowledged, however, that his study contains no direct evidence that treating sleep apnea will improve PIH or gestational diabetes.

The study relied on data from the 2003 National Inpatient Sample, sponsored by the Agency for Healthcare Research and Quality.

This large database includes all inpatient records from a sample of about 20% of U.S. community short-stay hospitals and provides weights to calculate national estimates.

Using this database, the investigators calculated that there were 3,979,840 deliveries in the United States in 2003, of which 167,227 were complicated by gestational diabetes and 300,902 were complicated by PIH.

The overall rate of sleep apnea for these women was 1.14/10,000—but that rate was 4.01/10,000 among women with gestational diabetes and 5.52/10,000 among women with PIH.

When controlled for age and race, women with sleep apnea were 3.5 times more likely to develop gestational diabetes; when controlled for obesity, the odds ratio was still 2.3.

Similarly, the odds ratio for PIH in women with sleep apnea was 6.6 when controlling for age and race, and 4.2 after also controlling for obesity.

In an interview, Dr. Nolledo acknowledged that the overall rate of OSA recorded in the database—just over 1/10,000, or 0.01%—is much lower than the 2%–4% rate of OSA estimated for the general population.

He attributed this in part to the fact that physicians often don't think to ask their pregnant patients about sleep-disordered breathing.

An alternative explanation for the results is that physicians may ask about sleep-disordered breathing more frequently when faced with patients with gestational diabetes or PIH, he said, and that this alone can account for the apparent increases in risk.

LOS ANGELES — A large prospective cohort study has found an association between long-term exposure to burning incense and cancers of the respiratory tract, according to a poster presentation by Dr. Jeppe T. Friborg at the annual meeting of the American Association for Cancer Research.

Among 61,320 Singapore Chinese, long-term incense users had more than twice the relative risk of non-nasopharyngeal carcinomas of the upper respiratory tract, compared with people who did not use incense.

The risk of squamous cell carcinomas of the lung rose 1.7-fold and the risk of squamous cell carcinomas of the entire respiratory tract rose 1.8-fold among long-term incense users, wrote Dr. Friborg of the University of Minnesota, Minneapolis, and colleagues.

The use of incense did not increase the risk of non-squamous cell carcinomas. Participants in the study were 45–74 years old and were cancer free when they enrolled between 1993 and 1998. They underwent a comprehensive interview on living conditions, dietary factors, and lifestyle factors. Investigators followed the cohort through 2005.

In the multivariate analysis, results were adjusted for age, gender, dialect group, education level, number of cigarettes smoked per day, years of smoking, frequency of alcohol intake, intake of isothiocyanates, intake of Chinese-style preserved foods, body mass index, and parity in women.

The investigators noted that the burning of incense is an integral part of daily life in large parts of Asia and is not restricted to places of worship: About half the population in Southeast Asia burns incense at home every day. Incense burning produces a great deal of particulate matter and releases many possible carcinogens including polyaromatic hydrocarbons, carbonyls, and benzene.

Risk of squamous cell carcinomasrose 1.8-fold in long-term users.

LOS ANGELES — A large prospective cohort study has found an association between long-term exposure to burning incense and cancers of the respiratory tract, according to a poster presentation by Dr. Jeppe T. Friborg at the annual meeting of the American Association for Cancer Research.

Among 61,320 Singapore Chinese, long-term incense users had more than twice the relative risk of non-nasopharyngeal carcinomas of the upper respiratory tract, compared with people who did not use incense.

The risk of squamous cell carcinomas of the lung rose 1.7-fold and the risk of squamous cell carcinomas of the entire respiratory tract rose 1.8-fold among long-term incense users, wrote Dr. Friborg of the University of Minnesota, Minneapolis, and colleagues.

The use of incense did not increase the risk of non-squamous cell carcinomas. Participants in the study were 45–74 years old and were cancer free when they enrolled between 1993 and 1998. They underwent a comprehensive interview on living conditions, dietary factors, and lifestyle factors. Investigators followed the cohort through 2005.

In the multivariate analysis, results were adjusted for age, gender, dialect group, education level, number of cigarettes smoked per day, years of smoking, frequency of alcohol intake, intake of isothiocyanates, intake of Chinese-style preserved foods, body mass index, and parity in women.

The investigators noted that the burning of incense is an integral part of daily life in large parts of Asia and is not restricted to places of worship: About half the population in Southeast Asia burns incense at home every day. Incense burning produces a great deal of particulate matter and releases many possible carcinogens including polyaromatic hydrocarbons, carbonyls, and benzene.

Risk of squamous cell carcinomasrose 1.8-fold in long-term users.

LOS ANGELES — A large prospective cohort study has found an association between long-term exposure to burning incense and cancers of the respiratory tract, according to a poster presentation by Dr. Jeppe T. Friborg at the annual meeting of the American Association for Cancer Research.

Among 61,320 Singapore Chinese, long-term incense users had more than twice the relative risk of non-nasopharyngeal carcinomas of the upper respiratory tract, compared with people who did not use incense.

The risk of squamous cell carcinomas of the lung rose 1.7-fold and the risk of squamous cell carcinomas of the entire respiratory tract rose 1.8-fold among long-term incense users, wrote Dr. Friborg of the University of Minnesota, Minneapolis, and colleagues.

The use of incense did not increase the risk of non-squamous cell carcinomas. Participants in the study were 45–74 years old and were cancer free when they enrolled between 1993 and 1998. They underwent a comprehensive interview on living conditions, dietary factors, and lifestyle factors. Investigators followed the cohort through 2005.

In the multivariate analysis, results were adjusted for age, gender, dialect group, education level, number of cigarettes smoked per day, years of smoking, frequency of alcohol intake, intake of isothiocyanates, intake of Chinese-style preserved foods, body mass index, and parity in women.

The investigators noted that the burning of incense is an integral part of daily life in large parts of Asia and is not restricted to places of worship: About half the population in Southeast Asia burns incense at home every day. Incense burning produces a great deal of particulate matter and releases many possible carcinogens including polyaromatic hydrocarbons, carbonyls, and benzene.

Risk of squamous cell carcinomasrose 1.8-fold in long-term users.

A bivalent vaccine for human papillomavirus manufactured by GlaxoSmithKline has shown greater than 90% efficacy against high-grade cervical intraepithelial neoplasia, according to interim results from a large, randomized controlled trial published online in the Lancet.

The study, led by Dr. Jorma Paavonen and colleagues, is called the Papilloma Trial to Prevent Cervical Cancer in Young Adults (PATRICIA), and involves 18,644 women, aged 15–25 years, from 14 countries in Europe, Asia, and North America. The participants were randomly assigned to receive three injections of the human papillomavirus (HPV) vaccine or a hepatitis A vaccine at months 0, 1, and 6 (Lancet 2007; DOI:10.1016/S0140-6736[07]60946-5).

The study was sponsored by GlaxoSmithKline. Several study investigators were employees of the company, and others, including Dr. Paavonen of the University of Helsinki received consulting and lecture fees from the pharmaceutical firm.

The vaccine, Cervarix, has not yet been approved by the Food and Drug Administration. Cervarix is a bivalent vaccine, active against HPV types 16 and 18, which account for 70% of all cases of cervical cancer.

In the current study, only 2 of the 9,319 women receiving Cervarix developed cervical intraepithelial neoplasia (CIN) of grade 2 or 3 and related to HPV 16 or 18, compared with 21 of the 9,325 women in the control group. This translates into an efficacy of 90%.

The vaccine showed 89% efficacy against grade 1 or higher CIN.

Virtually all women receiving the HPV vaccine (99.5%) had developed antibodies against HPV 16 and 18 after the second of the three injections.

In an editorial, Dr. Jessica A. Kahn of the University of Cincinnati and Dr. Robert D. Burk of the Albert Einstein College of Medicine, New York, called the results “encouraging” (Lancet 2007; DOI:10.1016/S0140-6736[07]60947-7).

However, they noted that the follow-up time was only about 15 months, which is short compared with the several decades over which cervical cancer often evolves. The enrollment criteria in the trial were relatively narrow, so it's unknown whether seroconversion rates, antibody titers, and efficacy rates will be as high when the vaccine is distributed to a wider population.

Dr. Kahn and Dr. Burk also emphasized that the vaccine was not without side effects. Although generally well tolerated and safe, the HPV vaccine caused significantly more local adverse events such as pain, redness, and swelling, than did the hepatitis A vaccine. Risks of general adverse events, including arthralgia, fatigue, and myalgia, also were significantly higher in the HPV group.

Dr. Kahn and Dr. Burk stressed the need for the vaccine to be made available in less-developed regions of the world, where cervical cancer makes the largest contribution to years of life lost to cancer. “Poverty is strongly associated with high-risk HPV infection and cervical cancer,” they wrote. “If those who live in poverty cannot access highly effective interventions such as HPV vaccines, disparities could worsen dramatically.”

A bivalent vaccine for human papillomavirus manufactured by GlaxoSmithKline has shown greater than 90% efficacy against high-grade cervical intraepithelial neoplasia, according to interim results from a large, randomized controlled trial published online in the Lancet.

The study, led by Dr. Jorma Paavonen and colleagues, is called the Papilloma Trial to Prevent Cervical Cancer in Young Adults (PATRICIA), and involves 18,644 women, aged 15–25 years, from 14 countries in Europe, Asia, and North America. The participants were randomly assigned to receive three injections of the human papillomavirus (HPV) vaccine or a hepatitis A vaccine at months 0, 1, and 6 (Lancet 2007; DOI:10.1016/S0140-6736[07]60946-5).

The study was sponsored by GlaxoSmithKline. Several study investigators were employees of the company, and others, including Dr. Paavonen of the University of Helsinki received consulting and lecture fees from the pharmaceutical firm.

The vaccine, Cervarix, has not yet been approved by the Food and Drug Administration. Cervarix is a bivalent vaccine, active against HPV types 16 and 18, which account for 70% of all cases of cervical cancer.

In the current study, only 2 of the 9,319 women receiving Cervarix developed cervical intraepithelial neoplasia (CIN) of grade 2 or 3 and related to HPV 16 or 18, compared with 21 of the 9,325 women in the control group. This translates into an efficacy of 90%.

The vaccine showed 89% efficacy against grade 1 or higher CIN.

Virtually all women receiving the HPV vaccine (99.5%) had developed antibodies against HPV 16 and 18 after the second of the three injections.

In an editorial, Dr. Jessica A. Kahn of the University of Cincinnati and Dr. Robert D. Burk of the Albert Einstein College of Medicine, New York, called the results “encouraging” (Lancet 2007; DOI:10.1016/S0140-6736[07]60947-7).

However, they noted that the follow-up time was only about 15 months, which is short compared with the several decades over which cervical cancer often evolves. The enrollment criteria in the trial were relatively narrow, so it's unknown whether seroconversion rates, antibody titers, and efficacy rates will be as high when the vaccine is distributed to a wider population.

Dr. Kahn and Dr. Burk also emphasized that the vaccine was not without side effects. Although generally well tolerated and safe, the HPV vaccine caused significantly more local adverse events such as pain, redness, and swelling, than did the hepatitis A vaccine. Risks of general adverse events, including arthralgia, fatigue, and myalgia, also were significantly higher in the HPV group.

Dr. Kahn and Dr. Burk stressed the need for the vaccine to be made available in less-developed regions of the world, where cervical cancer makes the largest contribution to years of life lost to cancer. “Poverty is strongly associated with high-risk HPV infection and cervical cancer,” they wrote. “If those who live in poverty cannot access highly effective interventions such as HPV vaccines, disparities could worsen dramatically.”

A bivalent vaccine for human papillomavirus manufactured by GlaxoSmithKline has shown greater than 90% efficacy against high-grade cervical intraepithelial neoplasia, according to interim results from a large, randomized controlled trial published online in the Lancet.

The study, led by Dr. Jorma Paavonen and colleagues, is called the Papilloma Trial to Prevent Cervical Cancer in Young Adults (PATRICIA), and involves 18,644 women, aged 15–25 years, from 14 countries in Europe, Asia, and North America. The participants were randomly assigned to receive three injections of the human papillomavirus (HPV) vaccine or a hepatitis A vaccine at months 0, 1, and 6 (Lancet 2007; DOI:10.1016/S0140-6736[07]60946-5).

The study was sponsored by GlaxoSmithKline. Several study investigators were employees of the company, and others, including Dr. Paavonen of the University of Helsinki received consulting and lecture fees from the pharmaceutical firm.

The vaccine, Cervarix, has not yet been approved by the Food and Drug Administration. Cervarix is a bivalent vaccine, active against HPV types 16 and 18, which account for 70% of all cases of cervical cancer.

In the current study, only 2 of the 9,319 women receiving Cervarix developed cervical intraepithelial neoplasia (CIN) of grade 2 or 3 and related to HPV 16 or 18, compared with 21 of the 9,325 women in the control group. This translates into an efficacy of 90%.

The vaccine showed 89% efficacy against grade 1 or higher CIN.

Virtually all women receiving the HPV vaccine (99.5%) had developed antibodies against HPV 16 and 18 after the second of the three injections.

In an editorial, Dr. Jessica A. Kahn of the University of Cincinnati and Dr. Robert D. Burk of the Albert Einstein College of Medicine, New York, called the results “encouraging” (Lancet 2007; DOI:10.1016/S0140-6736[07]60947-7).

However, they noted that the follow-up time was only about 15 months, which is short compared with the several decades over which cervical cancer often evolves. The enrollment criteria in the trial were relatively narrow, so it's unknown whether seroconversion rates, antibody titers, and efficacy rates will be as high when the vaccine is distributed to a wider population.

Dr. Kahn and Dr. Burk also emphasized that the vaccine was not without side effects. Although generally well tolerated and safe, the HPV vaccine caused significantly more local adverse events such as pain, redness, and swelling, than did the hepatitis A vaccine. Risks of general adverse events, including arthralgia, fatigue, and myalgia, also were significantly higher in the HPV group.

Dr. Kahn and Dr. Burk stressed the need for the vaccine to be made available in less-developed regions of the world, where cervical cancer makes the largest contribution to years of life lost to cancer. “Poverty is strongly associated with high-risk HPV infection and cervical cancer,” they wrote. “If those who live in poverty cannot access highly effective interventions such as HPV vaccines, disparities could worsen dramatically.”