Heidi Splete

WASHINGTON — Pacemakers and implantable cardioverter defibrillators can extend survival and improve functionality in properly selected cardiac patients, but given the lack of data from elderly individuals, choices can be complex and challenging.

“We don't have very good long-term randomized, prospective clinical trials in the very elderly to know exactly what the best therapy is,” Dr. Brian Olshansky said at the annual meeting of the Society of Geriatric Cardiology.

“Not everyone is going to be saved with an implantable cardioverter defibrillator [ICD],” said Dr. Olshansky, a professor of medicine and a cardiac electrophysiologist at the University of Iowa, Iowa City.

But device therapy can be beneficial in elderly patients with tachyarrhythmias or bradyarrhythmias because these conditions can significantly impair the patient's daily activities, he noted.

On the basis of results from a recent review of a Medicare database, “what we can say is that people who receive ICDs [whether single chamber, dual chamber, or with cardiac resynchronization pacing], presumably for the right reason, do better than those who don't in a Medicare population,” Dr. Olshansky said (Heart Rhythm 2008;5:646–53).

However, the benefit of pacemakers in this population is less clear. In the Pacemaker Selection in the Elderly (PASE) study, a single-blind, prospective, randomized trial that examined quality of life after pacemaker implantation in patients with a mean age of 76 years, use of a pacemaker significantly improved quality of life in patients with symptomatic bradycardia, but there was no difference in survival between dual- and single-chamber pacemakers, said Dr. Olshansky (N. Engl. J. Med. 1998;338:1097–104).

In some cases a pacemaker is only part of the solution in lieu of medications or procedures to treat tachyarrhythmias such as atrial fibrillation. Atrioventricular (AV) junction ablation can be an effective means of controlling fast ventricular rates caused by atrial fibrillation, improving quality of life and functionality.

“In my experience, elderly patients seem to get a tremendous benefit from AV junctional ablation in cases with fast rates in atrial fibrillation not controlled with medical therapy,” Dr. Olshansky said.

“What is really most important is that an AV junctional ablation can allow patients to do what they want to do, like carrying groceries and climbing stairs,” said Dr. Olshansky.

Cardiac resynchronization therapy (CRT) for patients with impaired ventricular function, functional class III or IV heart failure, and a wide QRS complex may be an appropriate option, but it has not been well studied in patients older than 80 years, and it is more complicated and expensive than a single-site option, he noted.

But potential benefits of CRT include improved quality of life, as well as reduced heart failure symptoms and improved exercise tolerance. Also, studies have shown that CRT can reduce hospitalization and the risk of death.

The Multicenter InSync Randomized Clinical Evaluation (MIRACLE) study, which included patients approximately 65 years old, significantly improved functional status over a 6-month follow-up period after CRT pacing, compared with a control group who received a CRT implant without pacing (N. Engl. J. Med. 2002;346:1845–53).

Another growing area is atrial fibrillation ablation, but older patients are at greater risk from this long, arduous procedure and they may derive less benefit, compared with a younger population. Although study findings suggest that this procedure may improve quality of life more than antiarrhythmic medications, these data do not include elderly patients.

Dr. Olshansky stated that he has served as a consultant and a member of the speakers bureaus for Medtronic, Boston Scientific, and Novartis.

Device therapy can be beneficial in elderlypatients with tachyarrhythmias or bradyarrhythmias. DR. OLSHANSKY

WASHINGTON — Pacemakers and implantable cardioverter defibrillators can extend survival and improve functionality in properly selected cardiac patients, but given the lack of data from elderly individuals, choices can be complex and challenging.

“We don't have very good long-term randomized, prospective clinical trials in the very elderly to know exactly what the best therapy is,” Dr. Brian Olshansky said at the annual meeting of the Society of Geriatric Cardiology.

“Not everyone is going to be saved with an implantable cardioverter defibrillator [ICD],” said Dr. Olshansky, a professor of medicine and a cardiac electrophysiologist at the University of Iowa, Iowa City.

But device therapy can be beneficial in elderly patients with tachyarrhythmias or bradyarrhythmias because these conditions can significantly impair the patient's daily activities, he noted.

On the basis of results from a recent review of a Medicare database, “what we can say is that people who receive ICDs [whether single chamber, dual chamber, or with cardiac resynchronization pacing], presumably for the right reason, do better than those who don't in a Medicare population,” Dr. Olshansky said (Heart Rhythm 2008;5:646–53).

However, the benefit of pacemakers in this population is less clear. In the Pacemaker Selection in the Elderly (PASE) study, a single-blind, prospective, randomized trial that examined quality of life after pacemaker implantation in patients with a mean age of 76 years, use of a pacemaker significantly improved quality of life in patients with symptomatic bradycardia, but there was no difference in survival between dual- and single-chamber pacemakers, said Dr. Olshansky (N. Engl. J. Med. 1998;338:1097–104).

In some cases a pacemaker is only part of the solution in lieu of medications or procedures to treat tachyarrhythmias such as atrial fibrillation. Atrioventricular (AV) junction ablation can be an effective means of controlling fast ventricular rates caused by atrial fibrillation, improving quality of life and functionality.

“In my experience, elderly patients seem to get a tremendous benefit from AV junctional ablation in cases with fast rates in atrial fibrillation not controlled with medical therapy,” Dr. Olshansky said.

“What is really most important is that an AV junctional ablation can allow patients to do what they want to do, like carrying groceries and climbing stairs,” said Dr. Olshansky.

Cardiac resynchronization therapy (CRT) for patients with impaired ventricular function, functional class III or IV heart failure, and a wide QRS complex may be an appropriate option, but it has not been well studied in patients older than 80 years, and it is more complicated and expensive than a single-site option, he noted.

But potential benefits of CRT include improved quality of life, as well as reduced heart failure symptoms and improved exercise tolerance. Also, studies have shown that CRT can reduce hospitalization and the risk of death.

The Multicenter InSync Randomized Clinical Evaluation (MIRACLE) study, which included patients approximately 65 years old, significantly improved functional status over a 6-month follow-up period after CRT pacing, compared with a control group who received a CRT implant without pacing (N. Engl. J. Med. 2002;346:1845–53).

Another growing area is atrial fibrillation ablation, but older patients are at greater risk from this long, arduous procedure and they may derive less benefit, compared with a younger population. Although study findings suggest that this procedure may improve quality of life more than antiarrhythmic medications, these data do not include elderly patients.

Dr. Olshansky stated that he has served as a consultant and a member of the speakers bureaus for Medtronic, Boston Scientific, and Novartis.

Device therapy can be beneficial in elderlypatients with tachyarrhythmias or bradyarrhythmias. DR. OLSHANSKY

WASHINGTON — Pacemakers and implantable cardioverter defibrillators can extend survival and improve functionality in properly selected cardiac patients, but given the lack of data from elderly individuals, choices can be complex and challenging.

“We don't have very good long-term randomized, prospective clinical trials in the very elderly to know exactly what the best therapy is,” Dr. Brian Olshansky said at the annual meeting of the Society of Geriatric Cardiology.

“Not everyone is going to be saved with an implantable cardioverter defibrillator [ICD],” said Dr. Olshansky, a professor of medicine and a cardiac electrophysiologist at the University of Iowa, Iowa City.

But device therapy can be beneficial in elderly patients with tachyarrhythmias or bradyarrhythmias because these conditions can significantly impair the patient's daily activities, he noted.

On the basis of results from a recent review of a Medicare database, “what we can say is that people who receive ICDs [whether single chamber, dual chamber, or with cardiac resynchronization pacing], presumably for the right reason, do better than those who don't in a Medicare population,” Dr. Olshansky said (Heart Rhythm 2008;5:646–53).

However, the benefit of pacemakers in this population is less clear. In the Pacemaker Selection in the Elderly (PASE) study, a single-blind, prospective, randomized trial that examined quality of life after pacemaker implantation in patients with a mean age of 76 years, use of a pacemaker significantly improved quality of life in patients with symptomatic bradycardia, but there was no difference in survival between dual- and single-chamber pacemakers, said Dr. Olshansky (N. Engl. J. Med. 1998;338:1097–104).

In some cases a pacemaker is only part of the solution in lieu of medications or procedures to treat tachyarrhythmias such as atrial fibrillation. Atrioventricular (AV) junction ablation can be an effective means of controlling fast ventricular rates caused by atrial fibrillation, improving quality of life and functionality.

“In my experience, elderly patients seem to get a tremendous benefit from AV junctional ablation in cases with fast rates in atrial fibrillation not controlled with medical therapy,” Dr. Olshansky said.

“What is really most important is that an AV junctional ablation can allow patients to do what they want to do, like carrying groceries and climbing stairs,” said Dr. Olshansky.

Cardiac resynchronization therapy (CRT) for patients with impaired ventricular function, functional class III or IV heart failure, and a wide QRS complex may be an appropriate option, but it has not been well studied in patients older than 80 years, and it is more complicated and expensive than a single-site option, he noted.

But potential benefits of CRT include improved quality of life, as well as reduced heart failure symptoms and improved exercise tolerance. Also, studies have shown that CRT can reduce hospitalization and the risk of death.

The Multicenter InSync Randomized Clinical Evaluation (MIRACLE) study, which included patients approximately 65 years old, significantly improved functional status over a 6-month follow-up period after CRT pacing, compared with a control group who received a CRT implant without pacing (N. Engl. J. Med. 2002;346:1845–53).

Another growing area is atrial fibrillation ablation, but older patients are at greater risk from this long, arduous procedure and they may derive less benefit, compared with a younger population. Although study findings suggest that this procedure may improve quality of life more than antiarrhythmic medications, these data do not include elderly patients.

Dr. Olshansky stated that he has served as a consultant and a member of the speakers bureaus for Medtronic, Boston Scientific, and Novartis.

Device therapy can be beneficial in elderlypatients with tachyarrhythmias or bradyarrhythmias. DR. OLSHANSKY

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease, and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and Crohn's-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two randomized, controlled trials—ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients).

The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels.

“We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. In addition, natalizumab use was associated with a comparable reduction of 30% in the Crohn's-related hospitalization rate, but this difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The Crohn's-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients).

“Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” Dr. Sands added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI).

Dr. Sands has received consulting fees, grants, and research support from multiple pharmaceutical companies.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease, and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and Crohn's-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two randomized, controlled trials—ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients).

The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels.

“We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. In addition, natalizumab use was associated with a comparable reduction of 30% in the Crohn's-related hospitalization rate, but this difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The Crohn's-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients).

“Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” Dr. Sands added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI).

Dr. Sands has received consulting fees, grants, and research support from multiple pharmaceutical companies.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease, and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and Crohn's-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two randomized, controlled trials—ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients).

The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels.

“We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. In addition, natalizumab use was associated with a comparable reduction of 30% in the Crohn's-related hospitalization rate, but this difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The Crohn's-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients).

“Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” Dr. Sands added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI).

Dr. Sands has received consulting fees, grants, and research support from multiple pharmaceutical companies.

ELSEVIER GLOBAL MEDICAL NEWS

Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11-12 years and young women aged 13-26 years. HPV has been identified as a leading cause of cervical cancer.

Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.

To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11-17 years who were visitors to a university-based primary care clinic.

The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).

Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year.

Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the HPV vaccination series.

None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine.

Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.

Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.

There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.

“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.

The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.

But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.

Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.

The study was funded by grants from Merck & Co. and the National Institutes of Health.

Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11-12 years and young women aged 13-26 years. HPV has been identified as a leading cause of cervical cancer.

Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.

To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11-17 years who were visitors to a university-based primary care clinic.

The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).

Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year.

Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the HPV vaccination series.

None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine.

Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.

Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.

There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.

“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.

The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.

But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.

Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.

The study was funded by grants from Merck & Co. and the National Institutes of Health.

Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11-12 years and young women aged 13-26 years. HPV has been identified as a leading cause of cervical cancer.

Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.

To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11-17 years who were visitors to a university-based primary care clinic.

The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).

Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year.

Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the HPV vaccination series.

None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine.

Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.

Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.

There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.

“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.

The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.

But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.

Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.

The study was funded by grants from Merck & Co. and the National Institutes of Health.

WASHINGTON — As long as they're healthy, adults of any age should be encouraged to exercise, because studies show that it's a safe way to improve their cardiovascular health.

“It turns out that healthy older adults are able to make the necessary cardiovascular adjustments—and physiological homeostasis is preserved—and they are able to exercise effectively,” said Douglas Seals, Ph.D., a physiologist who studies aging and exercise at the University of Colorado, Boulder. He spoke at the annual meeting of the Society of Geriatric Cardiology.

“Aging will limit the absolute intensity and duration of submaximal aerobic exercise that can be performed by older adults…. However, performance of sustained submaximal exercise is not impaired by advancing age,” said Dr. Seals.

Dr. Seals cited a study that compared measurements during and after submaximal physical exertion in sedentary and trained groups of both healthy young men (aged 20–32 years) and healthy older men (aged 60–70 years). The volunteers walked on a treadmill for 60 minutes with enough effort to reach 70% of their maximum oxygen uptake, or VO₂ max. Both groups of older men had smaller increases in heart rate and lower rates of perceived exertion than did the younger men. Plasma lactate responses, which can be used to indicate metabolic stress in muscles, were also smaller in the older men. Plasma catecholamine responses, which can show a physiological stress response to exercise, barely increased in any of the men (J. Appl. Physiol. 1988;65:900-8).

“One could reasonably interpret these data to mean that older adults undergo a smaller increase in physiological stress from the resting state, compared with young adults in submaximal exercise conditions,” said Dr. Seals.

He and his colleagues reinforced these findings in a similar study of young and elderly men during a 45-minute treadmill walk (Clin. Physiol. 1995;15:169-81). The older men had lesser increases in heart rate, internal body temperature, and plasma norepinephrine concentrations than did the younger group.

The take-home message is that older adults make the necessary cardiovascular adjustments to handle submaximal exercise, he said.

WASHINGTON — As long as they're healthy, adults of any age should be encouraged to exercise, because studies show that it's a safe way to improve their cardiovascular health.

“It turns out that healthy older adults are able to make the necessary cardiovascular adjustments—and physiological homeostasis is preserved—and they are able to exercise effectively,” said Douglas Seals, Ph.D., a physiologist who studies aging and exercise at the University of Colorado, Boulder. He spoke at the annual meeting of the Society of Geriatric Cardiology.

“Aging will limit the absolute intensity and duration of submaximal aerobic exercise that can be performed by older adults…. However, performance of sustained submaximal exercise is not impaired by advancing age,” said Dr. Seals.

Dr. Seals cited a study that compared measurements during and after submaximal physical exertion in sedentary and trained groups of both healthy young men (aged 20–32 years) and healthy older men (aged 60–70 years). The volunteers walked on a treadmill for 60 minutes with enough effort to reach 70% of their maximum oxygen uptake, or VO₂ max. Both groups of older men had smaller increases in heart rate and lower rates of perceived exertion than did the younger men. Plasma lactate responses, which can be used to indicate metabolic stress in muscles, were also smaller in the older men. Plasma catecholamine responses, which can show a physiological stress response to exercise, barely increased in any of the men (J. Appl. Physiol. 1988;65:900-8).

“One could reasonably interpret these data to mean that older adults undergo a smaller increase in physiological stress from the resting state, compared with young adults in submaximal exercise conditions,” said Dr. Seals.

He and his colleagues reinforced these findings in a similar study of young and elderly men during a 45-minute treadmill walk (Clin. Physiol. 1995;15:169-81). The older men had lesser increases in heart rate, internal body temperature, and plasma norepinephrine concentrations than did the younger group.

The take-home message is that older adults make the necessary cardiovascular adjustments to handle submaximal exercise, he said.

WASHINGTON — As long as they're healthy, adults of any age should be encouraged to exercise, because studies show that it's a safe way to improve their cardiovascular health.

“It turns out that healthy older adults are able to make the necessary cardiovascular adjustments—and physiological homeostasis is preserved—and they are able to exercise effectively,” said Douglas Seals, Ph.D., a physiologist who studies aging and exercise at the University of Colorado, Boulder. He spoke at the annual meeting of the Society of Geriatric Cardiology.

“Aging will limit the absolute intensity and duration of submaximal aerobic exercise that can be performed by older adults…. However, performance of sustained submaximal exercise is not impaired by advancing age,” said Dr. Seals.

Dr. Seals cited a study that compared measurements during and after submaximal physical exertion in sedentary and trained groups of both healthy young men (aged 20–32 years) and healthy older men (aged 60–70 years). The volunteers walked on a treadmill for 60 minutes with enough effort to reach 70% of their maximum oxygen uptake, or VO₂ max. Both groups of older men had smaller increases in heart rate and lower rates of perceived exertion than did the younger men. Plasma lactate responses, which can be used to indicate metabolic stress in muscles, were also smaller in the older men. Plasma catecholamine responses, which can show a physiological stress response to exercise, barely increased in any of the men (J. Appl. Physiol. 1988;65:900-8).

“One could reasonably interpret these data to mean that older adults undergo a smaller increase in physiological stress from the resting state, compared with young adults in submaximal exercise conditions,” said Dr. Seals.

He and his colleagues reinforced these findings in a similar study of young and elderly men during a 45-minute treadmill walk (Clin. Physiol. 1995;15:169-81). The older men had lesser increases in heart rate, internal body temperature, and plasma norepinephrine concentrations than did the younger group.

The take-home message is that older adults make the necessary cardiovascular adjustments to handle submaximal exercise, he said.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028]).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted.

“We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” the investigators wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028]).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted.

“We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” the investigators wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028]).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted.

“We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” the investigators wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

SAN DIEGO — Several preoperative factors—a longer bypass limb length, low vitamin D levels, and African American ethnicity—were significant predictors of postoperative vitamin D deficiency in a study of 145 patients undergoing gastric bypass surgery.

Vitamin D deficiency can place such patients at increased risk for calcium and parathyroid hormone (PTH) abnormalities, and identifying the deficiency prior to surgery allows clinicians to intervene, Dr. Judy Jin wrote in a poster presented at the annual Digestive Disease Week.

Dr. Jin, of the department of surgery at Case Western Reserve University in Cleveland, and her colleagues reviewed data from 145 patients who underwent Roux-en-Y gastric bypass surgery between January 2005 and October 2006. The average age of the patients was 44 years, and the average BMI was 49 kg/m

The researchers tracked patient demographics and the laboratory values of calcium, vitamin D, and parathyroid hormone at 3-month intervals for 1 year. Overall, 42% of the patients had vitamin D deficiency (defined as vitamin D levels less than 20 ng/mL) either before surgery or during the 1-year follow-up period.

In a multivariate analysis, patients with postoperative vitamin D deficiency had significantly lower preoperative vitamin D levels than did those who didn't have postoperative deficiency (19.9 ng/mL vs. 30.0 ng/mL). Patients with postoperative vitamin D deficiency also were significantly more likely to have had a longer limb bypass (165 cm) vs. a short limb bypass (75 cm) and to be African American vs. another ethnicity. Preoperative PTH levels, age, sex, or reduction in BMI had no apparent effect on postoperative vitamin D.

Dr. Jin reported that she had no conflicts to disclose.

SAN DIEGO — Several preoperative factors—a longer bypass limb length, low vitamin D levels, and African American ethnicity—were significant predictors of postoperative vitamin D deficiency in a study of 145 patients undergoing gastric bypass surgery.

Vitamin D deficiency can place such patients at increased risk for calcium and parathyroid hormone (PTH) abnormalities, and identifying the deficiency prior to surgery allows clinicians to intervene, Dr. Judy Jin wrote in a poster presented at the annual Digestive Disease Week.

Dr. Jin, of the department of surgery at Case Western Reserve University in Cleveland, and her colleagues reviewed data from 145 patients who underwent Roux-en-Y gastric bypass surgery between January 2005 and October 2006. The average age of the patients was 44 years, and the average BMI was 49 kg/m

The researchers tracked patient demographics and the laboratory values of calcium, vitamin D, and parathyroid hormone at 3-month intervals for 1 year. Overall, 42% of the patients had vitamin D deficiency (defined as vitamin D levels less than 20 ng/mL) either before surgery or during the 1-year follow-up period.

In a multivariate analysis, patients with postoperative vitamin D deficiency had significantly lower preoperative vitamin D levels than did those who didn't have postoperative deficiency (19.9 ng/mL vs. 30.0 ng/mL). Patients with postoperative vitamin D deficiency also were significantly more likely to have had a longer limb bypass (165 cm) vs. a short limb bypass (75 cm) and to be African American vs. another ethnicity. Preoperative PTH levels, age, sex, or reduction in BMI had no apparent effect on postoperative vitamin D.

Dr. Jin reported that she had no conflicts to disclose.

SAN DIEGO — Several preoperative factors—a longer bypass limb length, low vitamin D levels, and African American ethnicity—were significant predictors of postoperative vitamin D deficiency in a study of 145 patients undergoing gastric bypass surgery.

Vitamin D deficiency can place such patients at increased risk for calcium and parathyroid hormone (PTH) abnormalities, and identifying the deficiency prior to surgery allows clinicians to intervene, Dr. Judy Jin wrote in a poster presented at the annual Digestive Disease Week.

Dr. Jin, of the department of surgery at Case Western Reserve University in Cleveland, and her colleagues reviewed data from 145 patients who underwent Roux-en-Y gastric bypass surgery between January 2005 and October 2006. The average age of the patients was 44 years, and the average BMI was 49 kg/m

The researchers tracked patient demographics and the laboratory values of calcium, vitamin D, and parathyroid hormone at 3-month intervals for 1 year. Overall, 42% of the patients had vitamin D deficiency (defined as vitamin D levels less than 20 ng/mL) either before surgery or during the 1-year follow-up period.

In a multivariate analysis, patients with postoperative vitamin D deficiency had significantly lower preoperative vitamin D levels than did those who didn't have postoperative deficiency (19.9 ng/mL vs. 30.0 ng/mL). Patients with postoperative vitamin D deficiency also were significantly more likely to have had a longer limb bypass (165 cm) vs. a short limb bypass (75 cm) and to be African American vs. another ethnicity. Preoperative PTH levels, age, sex, or reduction in BMI had no apparent effect on postoperative vitamin D.

Dr. Jin reported that she had no conflicts to disclose.

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Older age was the strongest predictor of early mortality in adults with gastrointestinal bleeding after investigators controlled for medications and comorbidities, according to data from more than 1,000 adults treated at a single medical center.

More clinicians have turned to low-dose aspirin and antithrombotic agents for cardiovascular disease prevention, but the interaction of these products with other risk factors for GI bleeding has not been studied thoroughly.

“We aimed to assess the 30-day mortality after upper gastrointestinal bleeding in association with the use of NSAIDs, low-dose aspirin, and other antithrombotic drugs,” Dr. Ali S. Taha of Crosshouse Hospital and the University of Glasgow, Scotland, and associates wrote in a poster presented at the annual Digestive Disease Week.

The investigators analyzed data from 1,014 adults who presented with a first episode of upper GI bleeding. A total of 45% of the patients were aged 65 years and older, and 8.1% of these patients died within 30 days of bleeding, compared with 1.3% of the younger patients.

After adjustment for multiple variables, patients aged 65 years and older had a significantly greater risk of 30-day mortality compared with their younger counterparts. In a univariate analysis, cerebrovascular disease, cardiovascular disease, and the use of diuretics, digoxin, and either low-dose aspirin or other antithrombotic drugs were significantly associated with an increased risk of 30-day mortality. Low-dose aspirin was defined as 75 mg/day, and the antithrombotic drugs included clopidogrel, dipyridamole, and warfarin.

Use of NSAIDs had no significant impact on 30-day mortality, and the specific withdrawal of rofecoxib (Vioxx) had no apparent effect on 30-day mortality rates in this population. The Blatchford score (an accepted measure of risk in patients with upper GI bleeding) was calculated using both clinical and laboratory data at each patient's presentation. Patients scoring higher than 10 on this measure had five times the risk of early death, compared with patients scoring 0-2.

Despite the importance of comorbidities and medication use, the results suggest that age is a strong and independent predictor of early mortality in patients with upper GI bleeding. More studies are needed to determine the clinical implications for treatment, Dr. Taha said in an interview. “Ulcer prevention should be considered seriously in elderly patients, particularly in the presence of other comorbid conditions and use of ulcerogenic drugs. And once bleeding has taken place, such patients should be targeted for intensive management.”

Dr. Taha said he has received grants and research support from Astellas Pharma Inc., AstraZeneca Pharmaceuticals, Merck & Co., and Yamanouchi Pharmaceutical Co.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Older age was the strongest predictor of early mortality in adults with gastrointestinal bleeding after investigators controlled for medications and comorbidities, according to data from more than 1,000 adults treated at a single medical center.

More clinicians have turned to low-dose aspirin and antithrombotic agents for cardiovascular disease prevention, but the interaction of these products with other risk factors for GI bleeding has not been studied thoroughly.

“We aimed to assess the 30-day mortality after upper gastrointestinal bleeding in association with the use of NSAIDs, low-dose aspirin, and other antithrombotic drugs,” Dr. Ali S. Taha of Crosshouse Hospital and the University of Glasgow, Scotland, and associates wrote in a poster presented at the annual Digestive Disease Week.

The investigators analyzed data from 1,014 adults who presented with a first episode of upper GI bleeding. A total of 45% of the patients were aged 65 years and older, and 8.1% of these patients died within 30 days of bleeding, compared with 1.3% of the younger patients.

After adjustment for multiple variables, patients aged 65 years and older had a significantly greater risk of 30-day mortality compared with their younger counterparts. In a univariate analysis, cerebrovascular disease, cardiovascular disease, and the use of diuretics, digoxin, and either low-dose aspirin or other antithrombotic drugs were significantly associated with an increased risk of 30-day mortality. Low-dose aspirin was defined as 75 mg/day, and the antithrombotic drugs included clopidogrel, dipyridamole, and warfarin.

Use of NSAIDs had no significant impact on 30-day mortality, and the specific withdrawal of rofecoxib (Vioxx) had no apparent effect on 30-day mortality rates in this population. The Blatchford score (an accepted measure of risk in patients with upper GI bleeding) was calculated using both clinical and laboratory data at each patient's presentation. Patients scoring higher than 10 on this measure had five times the risk of early death, compared with patients scoring 0-2.

Despite the importance of comorbidities and medication use, the results suggest that age is a strong and independent predictor of early mortality in patients with upper GI bleeding. More studies are needed to determine the clinical implications for treatment, Dr. Taha said in an interview. “Ulcer prevention should be considered seriously in elderly patients, particularly in the presence of other comorbid conditions and use of ulcerogenic drugs. And once bleeding has taken place, such patients should be targeted for intensive management.”

Dr. Taha said he has received grants and research support from Astellas Pharma Inc., AstraZeneca Pharmaceuticals, Merck & Co., and Yamanouchi Pharmaceutical Co.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Older age was the strongest predictor of early mortality in adults with gastrointestinal bleeding after investigators controlled for medications and comorbidities, according to data from more than 1,000 adults treated at a single medical center.

More clinicians have turned to low-dose aspirin and antithrombotic agents for cardiovascular disease prevention, but the interaction of these products with other risk factors for GI bleeding has not been studied thoroughly.

“We aimed to assess the 30-day mortality after upper gastrointestinal bleeding in association with the use of NSAIDs, low-dose aspirin, and other antithrombotic drugs,” Dr. Ali S. Taha of Crosshouse Hospital and the University of Glasgow, Scotland, and associates wrote in a poster presented at the annual Digestive Disease Week.

The investigators analyzed data from 1,014 adults who presented with a first episode of upper GI bleeding. A total of 45% of the patients were aged 65 years and older, and 8.1% of these patients died within 30 days of bleeding, compared with 1.3% of the younger patients.

After adjustment for multiple variables, patients aged 65 years and older had a significantly greater risk of 30-day mortality compared with their younger counterparts. In a univariate analysis, cerebrovascular disease, cardiovascular disease, and the use of diuretics, digoxin, and either low-dose aspirin or other antithrombotic drugs were significantly associated with an increased risk of 30-day mortality. Low-dose aspirin was defined as 75 mg/day, and the antithrombotic drugs included clopidogrel, dipyridamole, and warfarin.

Use of NSAIDs had no significant impact on 30-day mortality, and the specific withdrawal of rofecoxib (Vioxx) had no apparent effect on 30-day mortality rates in this population. The Blatchford score (an accepted measure of risk in patients with upper GI bleeding) was calculated using both clinical and laboratory data at each patient's presentation. Patients scoring higher than 10 on this measure had five times the risk of early death, compared with patients scoring 0-2.

Despite the importance of comorbidities and medication use, the results suggest that age is a strong and independent predictor of early mortality in patients with upper GI bleeding. More studies are needed to determine the clinical implications for treatment, Dr. Taha said in an interview. “Ulcer prevention should be considered seriously in elderly patients, particularly in the presence of other comorbid conditions and use of ulcerogenic drugs. And once bleeding has taken place, such patients should be targeted for intensive management.”

Dr. Taha said he has received grants and research support from Astellas Pharma Inc., AstraZeneca Pharmaceuticals, Merck & Co., and Yamanouchi Pharmaceutical Co.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease (CD), and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and CD-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two previous randomized, controlled trials—ENCORE (Evaluation of Nifedipine and Cerivastatin on the Recovery of Endothelial Function) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients). The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels. “We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. Natalizumab use also was associated with a comparable 30% reduction in the CD-related hospitalization rate, but the difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The CD-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients). “Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” he added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI). Age, gender, and baseline steroid and immunosuppressant use were not associated with risk of hospitalization.

Dr. Sands has received consulting fees, grants, and research support from companies including Abbott Laboratories, Centocor Inc., Genentech Inc., Procter & Gamble Pharmaceuticals Inc., Otsuka America Pharmaceutical Inc., Shire PLC, and UCB BioPharma.

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease (CD), and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and CD-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two previous randomized, controlled trials—ENCORE (Evaluation of Nifedipine and Cerivastatin on the Recovery of Endothelial Function) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients). The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels. “We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. Natalizumab use also was associated with a comparable 30% reduction in the CD-related hospitalization rate, but the difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The CD-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients). “Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” he added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI). Age, gender, and baseline steroid and immunosuppressant use were not associated with risk of hospitalization.

Dr. Sands has received consulting fees, grants, and research support from companies including Abbott Laboratories, Centocor Inc., Genentech Inc., Procter & Gamble Pharmaceuticals Inc., Otsuka America Pharmaceutical Inc., Shire PLC, and UCB BioPharma.

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease (CD), and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and CD-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two previous randomized, controlled trials—ENCORE (Evaluation of Nifedipine and Cerivastatin on the Recovery of Endothelial Function) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients). The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels. “We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. Natalizumab use also was associated with a comparable 30% reduction in the CD-related hospitalization rate, but the difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The CD-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients). “Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” he added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI). Age, gender, and baseline steroid and immunosuppressant use were not associated with risk of hospitalization.

Dr. Sands has received consulting fees, grants, and research support from companies including Abbott Laboratories, Centocor Inc., Genentech Inc., Procter & Gamble Pharmaceuticals Inc., Otsuka America Pharmaceutical Inc., Shire PLC, and UCB BioPharma.

BALTIMORE – Moderate to severe sleep apnea significantly increased the risk of all-cause mortality, according to 14 years of follow-up data from a large community sample.

“Sleep apnea is a disease of public health significance,” said Nathaniel Marshall, Ph.D., of the University of Sydney, who presented results from the Busselton Health Study at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have suggested that obstructive sleep apnea (OSA) increases the risk of death from cardiovascular disease, Dr. Marshall said. Until recently, however, the role of sleep apnea as an independent predictor of all-cause mortality has not been well studied, he added.

The Busselton Health Study is an ongoing community-based study in Busselton, Western Australia.

For the study, the researchers analyzed data from 400 community-dwelling adults aged 45-60 years. All of the participants were tested for OSA using a home sleep apnea monitoring device. Sleep apnea was quantified using the respiratory disturbance index (RDI), and moderate to severe apnea was defined as an RDI score of 15 or more respiratory disruptions per hour of sleep.

Complete data were available from 380 participants (278 men and 102 women) after an average of 13.4 years. The mortality rate was significantly higher (33.3%) among the 18 participants who had moderate to severe apnea (six deaths), compared with 6.5% among the 77 participants with mild OSA (five deaths) and 7.7% among the 285 participants without OSA (22 deaths).

Compared with people who did not have sleep apnea, the mortality hazard ratio was 6.24 for people with moderate to severe sleep apnea, after the researchers controlled for risk factors including age, gender, body mass index, mean arterial pressure (as a measure of blood pressure), smoking status, total cholesterol, HDL cholesterol, diabetes status, and physician-diagnosed angina.

“I was suspicious of the size of this effect,” Dr. Marshall said. “If you put this same model into an odds ratio, you get an odds ratio of about 10.” To put it another way, “sleep apnea has about the same effect on mortality as getting 18 years older,” he said.

But the results reflect similar recent findings from two studies in the United States–the multicenter Sleep Heart Health Study and the Wisconsin Sleep Study–that also show significant independent associations between OSA and all-cause mortality.

The association between moderate to severe OSA and all-cause mortality in the Busselton Health Study persisted even in a partly adjusted model that did not control for blood pressure. That model was used for comparison because OSA is a known cause of hypertension, Dr. Marshall noted. However, the researchers found no significant association between mild sleep apnea and an increased risk of death, which is good news, he said.

The study was limited by a lack of information about any treatment of sleep apnea in the study group, but the community-based format of the study kept it free of clinical referral bias, Dr. Marshall explained.

The results suggest that sleep apnea could be added to the list of standard mortality risk factors. But the findings also emphasize the need for randomized controlled trials of sleep apnea treatments that are designed to identify reductions in mortality risk, Dr. Marshall noted.

Dr. Marshall reported that he had no financial conflicts to disclose.

ELSEVIER GLOBAL MEDICAL NEWS

BALTIMORE – Moderate to severe sleep apnea significantly increased the risk of all-cause mortality, according to 14 years of follow-up data from a large community sample.

“Sleep apnea is a disease of public health significance,” said Nathaniel Marshall, Ph.D., of the University of Sydney, who presented results from the Busselton Health Study at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have suggested that obstructive sleep apnea (OSA) increases the risk of death from cardiovascular disease, Dr. Marshall said. Until recently, however, the role of sleep apnea as an independent predictor of all-cause mortality has not been well studied, he added.

The Busselton Health Study is an ongoing community-based study in Busselton, Western Australia.

For the study, the researchers analyzed data from 400 community-dwelling adults aged 45-60 years. All of the participants were tested for OSA using a home sleep apnea monitoring device. Sleep apnea was quantified using the respiratory disturbance index (RDI), and moderate to severe apnea was defined as an RDI score of 15 or more respiratory disruptions per hour of sleep.

Complete data were available from 380 participants (278 men and 102 women) after an average of 13.4 years. The mortality rate was significantly higher (33.3%) among the 18 participants who had moderate to severe apnea (six deaths), compared with 6.5% among the 77 participants with mild OSA (five deaths) and 7.7% among the 285 participants without OSA (22 deaths).

Compared with people who did not have sleep apnea, the mortality hazard ratio was 6.24 for people with moderate to severe sleep apnea, after the researchers controlled for risk factors including age, gender, body mass index, mean arterial pressure (as a measure of blood pressure), smoking status, total cholesterol, HDL cholesterol, diabetes status, and physician-diagnosed angina.

“I was suspicious of the size of this effect,” Dr. Marshall said. “If you put this same model into an odds ratio, you get an odds ratio of about 10.” To put it another way, “sleep apnea has about the same effect on mortality as getting 18 years older,” he said.

But the results reflect similar recent findings from two studies in the United States–the multicenter Sleep Heart Health Study and the Wisconsin Sleep Study–that also show significant independent associations between OSA and all-cause mortality.

The association between moderate to severe OSA and all-cause mortality in the Busselton Health Study persisted even in a partly adjusted model that did not control for blood pressure. That model was used for comparison because OSA is a known cause of hypertension, Dr. Marshall noted. However, the researchers found no significant association between mild sleep apnea and an increased risk of death, which is good news, he said.

The study was limited by a lack of information about any treatment of sleep apnea in the study group, but the community-based format of the study kept it free of clinical referral bias, Dr. Marshall explained.

The results suggest that sleep apnea could be added to the list of standard mortality risk factors. But the findings also emphasize the need for randomized controlled trials of sleep apnea treatments that are designed to identify reductions in mortality risk, Dr. Marshall noted.

Dr. Marshall reported that he had no financial conflicts to disclose.

ELSEVIER GLOBAL MEDICAL NEWS

BALTIMORE – Moderate to severe sleep apnea significantly increased the risk of all-cause mortality, according to 14 years of follow-up data from a large community sample.

“Sleep apnea is a disease of public health significance,” said Nathaniel Marshall, Ph.D., of the University of Sydney, who presented results from the Busselton Health Study at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have suggested that obstructive sleep apnea (OSA) increases the risk of death from cardiovascular disease, Dr. Marshall said. Until recently, however, the role of sleep apnea as an independent predictor of all-cause mortality has not been well studied, he added.

The Busselton Health Study is an ongoing community-based study in Busselton, Western Australia.

For the study, the researchers analyzed data from 400 community-dwelling adults aged 45-60 years. All of the participants were tested for OSA using a home sleep apnea monitoring device. Sleep apnea was quantified using the respiratory disturbance index (RDI), and moderate to severe apnea was defined as an RDI score of 15 or more respiratory disruptions per hour of sleep.

Complete data were available from 380 participants (278 men and 102 women) after an average of 13.4 years. The mortality rate was significantly higher (33.3%) among the 18 participants who had moderate to severe apnea (six deaths), compared with 6.5% among the 77 participants with mild OSA (five deaths) and 7.7% among the 285 participants without OSA (22 deaths).

Compared with people who did not have sleep apnea, the mortality hazard ratio was 6.24 for people with moderate to severe sleep apnea, after the researchers controlled for risk factors including age, gender, body mass index, mean arterial pressure (as a measure of blood pressure), smoking status, total cholesterol, HDL cholesterol, diabetes status, and physician-diagnosed angina.

“I was suspicious of the size of this effect,” Dr. Marshall said. “If you put this same model into an odds ratio, you get an odds ratio of about 10.” To put it another way, “sleep apnea has about the same effect on mortality as getting 18 years older,” he said.

But the results reflect similar recent findings from two studies in the United States–the multicenter Sleep Heart Health Study and the Wisconsin Sleep Study–that also show significant independent associations between OSA and all-cause mortality.

The association between moderate to severe OSA and all-cause mortality in the Busselton Health Study persisted even in a partly adjusted model that did not control for blood pressure. That model was used for comparison because OSA is a known cause of hypertension, Dr. Marshall noted. However, the researchers found no significant association between mild sleep apnea and an increased risk of death, which is good news, he said.

The study was limited by a lack of information about any treatment of sleep apnea in the study group, but the community-based format of the study kept it free of clinical referral bias, Dr. Marshall explained.

The results suggest that sleep apnea could be added to the list of standard mortality risk factors. But the findings also emphasize the need for randomized controlled trials of sleep apnea treatments that are designed to identify reductions in mortality risk, Dr. Marshall noted.

Dr. Marshall reported that he had no financial conflicts to disclose.

ELSEVIER GLOBAL MEDICAL NEWS