Michele G. Sullivan

HALIFAX, N.S. — Mountain biking is a growing cause of serious spinal injuries, often resulting in permanent disability, Dr. Neilson McLean reported in a poster at the 11th International Conference on Emergency Medicine.

Dr. McLean, an emergency medicine resident at the University of British Columbia, Vancouver, retrospectively examined the trauma and spine registries of three Vancouver-area trauma centers in 1994–2004. During that time, 399 patients were treated for injuries. Of those, 52 sustained spinal injuries.

Most of the patients were male (92%), and they had an average age of 33 years. Most (36) had been wearing a helmet at the time of the accident. The most common mechanism of injury was a fall over the handlebars (29). Their average injury severity score was 17. A total of 54% required surgery.

Most of the patients (71%) sustained a severe spinal injury; 33% had a root injury, 11% a central cord injury, 22% an incomplete spinal cord injury, and 34% a complete spinal cord injury.

Upon discharge, 54% had a neurologic deficit. A total of 32 patients were discharged to home. However, 15 went to a rehabilitation facility and 4 to an acute care facility. One patient left the hospital against medical advice.

HALIFAX, N.S. — Mountain biking is a growing cause of serious spinal injuries, often resulting in permanent disability, Dr. Neilson McLean reported in a poster at the 11th International Conference on Emergency Medicine.

Dr. McLean, an emergency medicine resident at the University of British Columbia, Vancouver, retrospectively examined the trauma and spine registries of three Vancouver-area trauma centers in 1994–2004. During that time, 399 patients were treated for injuries. Of those, 52 sustained spinal injuries.

Most of the patients were male (92%), and they had an average age of 33 years. Most (36) had been wearing a helmet at the time of the accident. The most common mechanism of injury was a fall over the handlebars (29). Their average injury severity score was 17. A total of 54% required surgery.

Most of the patients (71%) sustained a severe spinal injury; 33% had a root injury, 11% a central cord injury, 22% an incomplete spinal cord injury, and 34% a complete spinal cord injury.

Upon discharge, 54% had a neurologic deficit. A total of 32 patients were discharged to home. However, 15 went to a rehabilitation facility and 4 to an acute care facility. One patient left the hospital against medical advice.

HALIFAX, N.S. — Mountain biking is a growing cause of serious spinal injuries, often resulting in permanent disability, Dr. Neilson McLean reported in a poster at the 11th International Conference on Emergency Medicine.

Dr. McLean, an emergency medicine resident at the University of British Columbia, Vancouver, retrospectively examined the trauma and spine registries of three Vancouver-area trauma centers in 1994–2004. During that time, 399 patients were treated for injuries. Of those, 52 sustained spinal injuries.

Most of the patients were male (92%), and they had an average age of 33 years. Most (36) had been wearing a helmet at the time of the accident. The most common mechanism of injury was a fall over the handlebars (29). Their average injury severity score was 17. A total of 54% required surgery.

Most of the patients (71%) sustained a severe spinal injury; 33% had a root injury, 11% a central cord injury, 22% an incomplete spinal cord injury, and 34% a complete spinal cord injury.

Upon discharge, 54% had a neurologic deficit. A total of 32 patients were discharged to home. However, 15 went to a rehabilitation facility and 4 to an acute care facility. One patient left the hospital against medical advice.

HALIFAX, N.S. — Hospitals should plan on increasing their capacity by 110%–120% to cope with a major mass casualty.

An increase like that means significant changes in staffing, equipment, and prioritization of care—all of which are necessary to avoid being overwhelmed by a large disaster, Dr. Bruce Sawadsky said at the 11th International Conference on Emergency Medicine. “We might cause harm in terms of morbidity and mortality, but it's a risk we must take or we will be frozen in our ability to act,” Dr. Sawadsky cautioned.

Surge capacity is about the size of a hospital, not the size of the disaster, said Dr. Sawadsky, medical director of the Ontario Air Ambulance's Region One. “A surge can be four critically injured patients in a small-town hospital with one ventilator,” or dozens of patients in a large urban facility.

A minor surge will stress the emergency department, but can be completely handled within the hospital. A moderate surge overwhelms the hospital and mandates cooperation with other facilities in the community. A major surge, however, overwhelms the emergency medical services of the entire community and requires governmental assistance.

To cope with a major surge, hospitals should be able to expand their capacity by up to 120%, Dr. Sawadsky said. This is possible with preplanning that addresses bed space, staffing, equipment, and triage.

One of the most difficult concepts for medical workers is that levels of patient care will decline during a major surge. “In an event of this magnitude, the standard of care must be altered.”

Triage with this idea in mind will probably cause the most problems for staff, Dr. Sawadsky said. “You are trying to do the most good for the largest number of patients, and not focusing on individual patients who have little chance of a good outcome.”

Bed space will be at a premium. It's a given that patients will end up in hallways, both in the emergency department and on the floor. But finding space for everyone is possible with some planning. “Almost every hospital has wards that are not being used because of lack of staff. You can also double up ICU beds—one nurse watching multiple patients. You can use your recovery room as an intensive care unit, and use ward beds for critical care patients.”

Moving other patients will free up these beds, he said. “Have a preset plan for this, so you will know where you can send your long-term care and noncritically ill patients. It might be a nursing home or a high school gym.”

Noncritical emergency department patients also need to be dealt with. Ambulatory patients should probably be sent home; those who require minor trauma care, like a few stitches, should go to another facility.

Try to avoid moving any noncritical patients to other places within the hospital, however. “This can be a real bottleneck in getting critical care patients the care they need. Everyone who is not critically ill should go to an alternate care site.”

In terms of equipment during a surge, simplicity wins out over sophistication. “Higher volume means less sophistication. You are not going to have people with a lot of expertise to run these big sophisticated machines,” Dr. Sawadsky said.

Caches of emergency equipment in 50-patient bundles should be stored not only in the hospital, but also in multiple secure areas around the community. “There are always delays in getting to this equipment, so you need intense planning on how to move it quickly.”

During the event, a two-tier staffing hierarchy, with the more experienced staff overseeing the junior staff, will be most effective. Action cards should be drawn up during event planning, and are a great way to facilitate staff response. The cards outline exactly what every person will do, where they are to go, and who they will report to, and contain contact information for all staff.

HALIFAX, N.S. — Hospitals should plan on increasing their capacity by 110%–120% to cope with a major mass casualty.

An increase like that means significant changes in staffing, equipment, and prioritization of care—all of which are necessary to avoid being overwhelmed by a large disaster, Dr. Bruce Sawadsky said at the 11th International Conference on Emergency Medicine. “We might cause harm in terms of morbidity and mortality, but it's a risk we must take or we will be frozen in our ability to act,” Dr. Sawadsky cautioned.

Surge capacity is about the size of a hospital, not the size of the disaster, said Dr. Sawadsky, medical director of the Ontario Air Ambulance's Region One. “A surge can be four critically injured patients in a small-town hospital with one ventilator,” or dozens of patients in a large urban facility.

A minor surge will stress the emergency department, but can be completely handled within the hospital. A moderate surge overwhelms the hospital and mandates cooperation with other facilities in the community. A major surge, however, overwhelms the emergency medical services of the entire community and requires governmental assistance.

To cope with a major surge, hospitals should be able to expand their capacity by up to 120%, Dr. Sawadsky said. This is possible with preplanning that addresses bed space, staffing, equipment, and triage.

One of the most difficult concepts for medical workers is that levels of patient care will decline during a major surge. “In an event of this magnitude, the standard of care must be altered.”

Triage with this idea in mind will probably cause the most problems for staff, Dr. Sawadsky said. “You are trying to do the most good for the largest number of patients, and not focusing on individual patients who have little chance of a good outcome.”

Bed space will be at a premium. It's a given that patients will end up in hallways, both in the emergency department and on the floor. But finding space for everyone is possible with some planning. “Almost every hospital has wards that are not being used because of lack of staff. You can also double up ICU beds—one nurse watching multiple patients. You can use your recovery room as an intensive care unit, and use ward beds for critical care patients.”

Moving other patients will free up these beds, he said. “Have a preset plan for this, so you will know where you can send your long-term care and noncritically ill patients. It might be a nursing home or a high school gym.”

Noncritical emergency department patients also need to be dealt with. Ambulatory patients should probably be sent home; those who require minor trauma care, like a few stitches, should go to another facility.

Try to avoid moving any noncritical patients to other places within the hospital, however. “This can be a real bottleneck in getting critical care patients the care they need. Everyone who is not critically ill should go to an alternate care site.”

In terms of equipment during a surge, simplicity wins out over sophistication. “Higher volume means less sophistication. You are not going to have people with a lot of expertise to run these big sophisticated machines,” Dr. Sawadsky said.

Caches of emergency equipment in 50-patient bundles should be stored not only in the hospital, but also in multiple secure areas around the community. “There are always delays in getting to this equipment, so you need intense planning on how to move it quickly.”

During the event, a two-tier staffing hierarchy, with the more experienced staff overseeing the junior staff, will be most effective. Action cards should be drawn up during event planning, and are a great way to facilitate staff response. The cards outline exactly what every person will do, where they are to go, and who they will report to, and contain contact information for all staff.

HALIFAX, N.S. — Hospitals should plan on increasing their capacity by 110%–120% to cope with a major mass casualty.

An increase like that means significant changes in staffing, equipment, and prioritization of care—all of which are necessary to avoid being overwhelmed by a large disaster, Dr. Bruce Sawadsky said at the 11th International Conference on Emergency Medicine. “We might cause harm in terms of morbidity and mortality, but it's a risk we must take or we will be frozen in our ability to act,” Dr. Sawadsky cautioned.

Surge capacity is about the size of a hospital, not the size of the disaster, said Dr. Sawadsky, medical director of the Ontario Air Ambulance's Region One. “A surge can be four critically injured patients in a small-town hospital with one ventilator,” or dozens of patients in a large urban facility.

A minor surge will stress the emergency department, but can be completely handled within the hospital. A moderate surge overwhelms the hospital and mandates cooperation with other facilities in the community. A major surge, however, overwhelms the emergency medical services of the entire community and requires governmental assistance.

To cope with a major surge, hospitals should be able to expand their capacity by up to 120%, Dr. Sawadsky said. This is possible with preplanning that addresses bed space, staffing, equipment, and triage.

One of the most difficult concepts for medical workers is that levels of patient care will decline during a major surge. “In an event of this magnitude, the standard of care must be altered.”

Triage with this idea in mind will probably cause the most problems for staff, Dr. Sawadsky said. “You are trying to do the most good for the largest number of patients, and not focusing on individual patients who have little chance of a good outcome.”

Bed space will be at a premium. It's a given that patients will end up in hallways, both in the emergency department and on the floor. But finding space for everyone is possible with some planning. “Almost every hospital has wards that are not being used because of lack of staff. You can also double up ICU beds—one nurse watching multiple patients. You can use your recovery room as an intensive care unit, and use ward beds for critical care patients.”

Moving other patients will free up these beds, he said. “Have a preset plan for this, so you will know where you can send your long-term care and noncritically ill patients. It might be a nursing home or a high school gym.”

Noncritical emergency department patients also need to be dealt with. Ambulatory patients should probably be sent home; those who require minor trauma care, like a few stitches, should go to another facility.

Try to avoid moving any noncritical patients to other places within the hospital, however. “This can be a real bottleneck in getting critical care patients the care they need. Everyone who is not critically ill should go to an alternate care site.”

In terms of equipment during a surge, simplicity wins out over sophistication. “Higher volume means less sophistication. You are not going to have people with a lot of expertise to run these big sophisticated machines,” Dr. Sawadsky said.

Caches of emergency equipment in 50-patient bundles should be stored not only in the hospital, but also in multiple secure areas around the community. “There are always delays in getting to this equipment, so you need intense planning on how to move it quickly.”

During the event, a two-tier staffing hierarchy, with the more experienced staff overseeing the junior staff, will be most effective. Action cards should be drawn up during event planning, and are a great way to facilitate staff response. The cards outline exactly what every person will do, where they are to go, and who they will report to, and contain contact information for all staff.

MADRID — Asymptomatic carriers of the apo E4 gene show significant longitudinal decline on measures of frontally mediated cognitive skills and memory, Dr. Richard Caselli reported at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Dr. Caselli, chairman of neurology at the Mayo Clinic, Scottsdale, Ariz., followed 35 apo E4 carriers and 33 noncarriers for at least 6 years, during which time all study participants received neuropsychological testing every other year.

Patients who developed symptomatic cognitive impairment were dropped. At baseline, carriers performed slightly better than noncarriers on the auditory verbal learning test, short-term recall, long-term recall, and percent recall. By the end of the study period, carriers had declined significantly more than noncarriers in short-term recall as well as in mental arithmetic, digit symbol substitution, and freedom from distractibility—all frontal mediated cognitive domains.

MADRID — Asymptomatic carriers of the apo E4 gene show significant longitudinal decline on measures of frontally mediated cognitive skills and memory, Dr. Richard Caselli reported at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Dr. Caselli, chairman of neurology at the Mayo Clinic, Scottsdale, Ariz., followed 35 apo E4 carriers and 33 noncarriers for at least 6 years, during which time all study participants received neuropsychological testing every other year.

Patients who developed symptomatic cognitive impairment were dropped. At baseline, carriers performed slightly better than noncarriers on the auditory verbal learning test, short-term recall, long-term recall, and percent recall. By the end of the study period, carriers had declined significantly more than noncarriers in short-term recall as well as in mental arithmetic, digit symbol substitution, and freedom from distractibility—all frontal mediated cognitive domains.

MADRID — Asymptomatic carriers of the apo E4 gene show significant longitudinal decline on measures of frontally mediated cognitive skills and memory, Dr. Richard Caselli reported at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Dr. Caselli, chairman of neurology at the Mayo Clinic, Scottsdale, Ariz., followed 35 apo E4 carriers and 33 noncarriers for at least 6 years, during which time all study participants received neuropsychological testing every other year.

Patients who developed symptomatic cognitive impairment were dropped. At baseline, carriers performed slightly better than noncarriers on the auditory verbal learning test, short-term recall, long-term recall, and percent recall. By the end of the study period, carriers had declined significantly more than noncarriers in short-term recall as well as in mental arithmetic, digit symbol substitution, and freedom from distractibility—all frontal mediated cognitive domains.

MADRID — Prescriptions for atypical antipsychotics have not decreased significantly among elderly patients with dementia, despite the black box warning of an increased risk of death associated with the drugs, according to Henry Riordan, Ph.D., speaking at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Overall, prescribing has declined only 2.4%, even though the number of new prescriptions issued has decreased by 37%, Dr. Riordan said at the meeting presented by the Alzheimer's Association.

This pattern probably reflects physicians' perceptions that the clinical benefits of the drugs outweigh their well-documented risks for older dementia patients with serious behavioral issues.

More than 80% of Alzheimer's patients will eventually develop psychotic symptoms, said Dr. Riordan, vice president and global head of medical and scientific affairs for I3 Research in Basking Ridge, N.J. “These are the issues that typically result in institutionalization and take a big chunk out of these patients' quality of life,” he said in an interview.

The problem lands patients, families, and physicians on the horns of a very sharp dilemma. “Withholding the drugs is dangerous, especially when you are dealing with behavior that can be either self-injurious or harmful to caregivers,” Dr. Riordan said, but the risks of atypical antipsychotics were well documented years before the Food and Drug Administration's warning.

Fifteen of the 17 randomized atypical antipsychotic trials the FDA reviewed found a significantly increased risk of death—usually cardiovascular or infectious—among elderly, demented patients taking the drugs, compared with placebo. The resultant black box warning highlighted the danger and reiterated that the drugs are not approved for the treatment of patients with dementia-related psychosis.

To estimate the impact of the black box warning on prescribing patterns, Dr. Riordan examined claims data from a large U.S. health plan, for 10 months before and 10 months after the 2005 warning was issued. The database included 900,000 people older than 65 years of age; 20,515 had a diagnosis of dementia. Of those, 5,000 were taking at least one atypical antipsychotic before the black box warning.

Ten months after the warning, 4,883 people were still taking the drugs. New prescriptions had decreased significantly, however, declining from 3,423 to 2,148. “This probably tells us that if you were on the drug, you stayed on it, but that physicians might have been looking at something else for patients with new symptoms.”

A supporting pattern emerged when Dr. Riordan broke down the data by age: Prescriptions decreased more among patients younger than 81 (5%) than they did among older patients (0.73%). “Here we're probably seeing a risk-benefit ratio that's perceived as different for older people,” Dr. Riordan said.

“If someone has been on it with good efficacy, it would probably just be continued. But the physician's thought process might be very different for someone younger, in the earlier stages of the disease,” according to Dr. Riordan.

Among the six drugs included in the study (aripiprazole, clozapine, ziprasidone, risperidone, quetiapine, and olanzapine), only two showed significant pre- and post-warning prescribing changes. Prescriptions for quetiapine increased significantly, while those for olanzapine decreased significantly.

“It could be that quetiapine is being used more now for its sedative effect in sleep difficulty, and clozapine less due to its issues with increasing cardiovascular risk factors.”

Dr. Riordan now is investigating whether the decrease in new prescriptions caused any similar increases in prescriptions for alternative treatments, like mood stabilizers or antianxiolytics.

MADRID — Prescriptions for atypical antipsychotics have not decreased significantly among elderly patients with dementia, despite the black box warning of an increased risk of death associated with the drugs, according to Henry Riordan, Ph.D., speaking at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Overall, prescribing has declined only 2.4%, even though the number of new prescriptions issued has decreased by 37%, Dr. Riordan said at the meeting presented by the Alzheimer's Association.

This pattern probably reflects physicians' perceptions that the clinical benefits of the drugs outweigh their well-documented risks for older dementia patients with serious behavioral issues.

More than 80% of Alzheimer's patients will eventually develop psychotic symptoms, said Dr. Riordan, vice president and global head of medical and scientific affairs for I3 Research in Basking Ridge, N.J. “These are the issues that typically result in institutionalization and take a big chunk out of these patients' quality of life,” he said in an interview.

The problem lands patients, families, and physicians on the horns of a very sharp dilemma. “Withholding the drugs is dangerous, especially when you are dealing with behavior that can be either self-injurious or harmful to caregivers,” Dr. Riordan said, but the risks of atypical antipsychotics were well documented years before the Food and Drug Administration's warning.

Fifteen of the 17 randomized atypical antipsychotic trials the FDA reviewed found a significantly increased risk of death—usually cardiovascular or infectious—among elderly, demented patients taking the drugs, compared with placebo. The resultant black box warning highlighted the danger and reiterated that the drugs are not approved for the treatment of patients with dementia-related psychosis.

To estimate the impact of the black box warning on prescribing patterns, Dr. Riordan examined claims data from a large U.S. health plan, for 10 months before and 10 months after the 2005 warning was issued. The database included 900,000 people older than 65 years of age; 20,515 had a diagnosis of dementia. Of those, 5,000 were taking at least one atypical antipsychotic before the black box warning.

Ten months after the warning, 4,883 people were still taking the drugs. New prescriptions had decreased significantly, however, declining from 3,423 to 2,148. “This probably tells us that if you were on the drug, you stayed on it, but that physicians might have been looking at something else for patients with new symptoms.”

A supporting pattern emerged when Dr. Riordan broke down the data by age: Prescriptions decreased more among patients younger than 81 (5%) than they did among older patients (0.73%). “Here we're probably seeing a risk-benefit ratio that's perceived as different for older people,” Dr. Riordan said.

“If someone has been on it with good efficacy, it would probably just be continued. But the physician's thought process might be very different for someone younger, in the earlier stages of the disease,” according to Dr. Riordan.

Among the six drugs included in the study (aripiprazole, clozapine, ziprasidone, risperidone, quetiapine, and olanzapine), only two showed significant pre- and post-warning prescribing changes. Prescriptions for quetiapine increased significantly, while those for olanzapine decreased significantly.

“It could be that quetiapine is being used more now for its sedative effect in sleep difficulty, and clozapine less due to its issues with increasing cardiovascular risk factors.”

Dr. Riordan now is investigating whether the decrease in new prescriptions caused any similar increases in prescriptions for alternative treatments, like mood stabilizers or antianxiolytics.

MADRID — Prescriptions for atypical antipsychotics have not decreased significantly among elderly patients with dementia, despite the black box warning of an increased risk of death associated with the drugs, according to Henry Riordan, Ph.D., speaking at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Overall, prescribing has declined only 2.4%, even though the number of new prescriptions issued has decreased by 37%, Dr. Riordan said at the meeting presented by the Alzheimer's Association.

This pattern probably reflects physicians' perceptions that the clinical benefits of the drugs outweigh their well-documented risks for older dementia patients with serious behavioral issues.

More than 80% of Alzheimer's patients will eventually develop psychotic symptoms, said Dr. Riordan, vice president and global head of medical and scientific affairs for I3 Research in Basking Ridge, N.J. “These are the issues that typically result in institutionalization and take a big chunk out of these patients' quality of life,” he said in an interview.

The problem lands patients, families, and physicians on the horns of a very sharp dilemma. “Withholding the drugs is dangerous, especially when you are dealing with behavior that can be either self-injurious or harmful to caregivers,” Dr. Riordan said, but the risks of atypical antipsychotics were well documented years before the Food and Drug Administration's warning.

Fifteen of the 17 randomized atypical antipsychotic trials the FDA reviewed found a significantly increased risk of death—usually cardiovascular or infectious—among elderly, demented patients taking the drugs, compared with placebo. The resultant black box warning highlighted the danger and reiterated that the drugs are not approved for the treatment of patients with dementia-related psychosis.

To estimate the impact of the black box warning on prescribing patterns, Dr. Riordan examined claims data from a large U.S. health plan, for 10 months before and 10 months after the 2005 warning was issued. The database included 900,000 people older than 65 years of age; 20,515 had a diagnosis of dementia. Of those, 5,000 were taking at least one atypical antipsychotic before the black box warning.

Ten months after the warning, 4,883 people were still taking the drugs. New prescriptions had decreased significantly, however, declining from 3,423 to 2,148. “This probably tells us that if you were on the drug, you stayed on it, but that physicians might have been looking at something else for patients with new symptoms.”

A supporting pattern emerged when Dr. Riordan broke down the data by age: Prescriptions decreased more among patients younger than 81 (5%) than they did among older patients (0.73%). “Here we're probably seeing a risk-benefit ratio that's perceived as different for older people,” Dr. Riordan said.

“If someone has been on it with good efficacy, it would probably just be continued. But the physician's thought process might be very different for someone younger, in the earlier stages of the disease,” according to Dr. Riordan.

Among the six drugs included in the study (aripiprazole, clozapine, ziprasidone, risperidone, quetiapine, and olanzapine), only two showed significant pre- and post-warning prescribing changes. Prescriptions for quetiapine increased significantly, while those for olanzapine decreased significantly.

“It could be that quetiapine is being used more now for its sedative effect in sleep difficulty, and clozapine less due to its issues with increasing cardiovascular risk factors.”

Dr. Riordan now is investigating whether the decrease in new prescriptions caused any similar increases in prescriptions for alternative treatments, like mood stabilizers or antianxiolytics.

BOSTON — Intermittent intravenous ibandronate is at least as effective as daily oral ibandronate for increasing bone mineral density and may be preferable to oral dosing in patients with esophageal disease or compliance problems.

There are no fracture data for the intravenous dosing schedule, but the risk reduction that has been shown with oral ibandronate can probably be extrapolated to the intravenous form of the drug, Dr. Mone Zaidi said at the annual meeting of the Endocrine Society.

Oral ibandronate has been shown to reduce the risk of new vertebral fractures by up to 60% (Curr. Med. Res. Opin. 2005;21:391–401; J. Bone Miner. Res. 2004;19:1241–9).

“If you can show equivalence or superiority in bone mineral density changes to [the form] with proven fracture data, which we have done, I think everyone would agree that you can extrapolate that data,” said Dr. Zaidi, director of the Mount Sinai Bone Program, Mount Sinai School of Medicine, New York.

Dr. Zaidi presented 2-year bone mineral density (BMD) data from the ibandronate Dosing Intravenous Administration trial, a Roche-sponsored phase III study that compared two doses of intravenous ibandronate (2 mg every 2 months and 3 mg every 3 months) with the approved oral dosing schedule (2.5 mg daily). The study group included 1,400 postmenopausal women with low bone mass (T-scores of −3.3 for total spine and −2 for hip).

After 2 years, BMD at the lumbar spine increased significantly more in both intravenous groups than in the oral group (mean increase 6.4% for the 2 mg IV dose, 6.3% for the 3 mg IV dose, and 4.8% for the oral dose).

BMD increased similarly at all other sites measured, with consistently greater gains in both intravenous groups than in the oral group, Dr. Zaidi said.

At 2 years, the incidence of adverse events was similar across all groups. Flulike illnesses and gastrointestinal intolerance were seen primarily in the first year, with only slight increases in cumulative numbers during the second year.

There was no osteonecrosis of the jaw. Renal and urinary incidents were uncommon and similar across groups.

Fracture incident, which was reported as an adverse event, was low and similar in all groups, although Dr. Zaidi stressed that the study was not powered to prove fracture risk reduction.

The intermittent dosing would also be “a great way” to ensure compliance, according to Dr. Zaidi.

BOSTON — Intermittent intravenous ibandronate is at least as effective as daily oral ibandronate for increasing bone mineral density and may be preferable to oral dosing in patients with esophageal disease or compliance problems.

There are no fracture data for the intravenous dosing schedule, but the risk reduction that has been shown with oral ibandronate can probably be extrapolated to the intravenous form of the drug, Dr. Mone Zaidi said at the annual meeting of the Endocrine Society.

Oral ibandronate has been shown to reduce the risk of new vertebral fractures by up to 60% (Curr. Med. Res. Opin. 2005;21:391–401; J. Bone Miner. Res. 2004;19:1241–9).

“If you can show equivalence or superiority in bone mineral density changes to [the form] with proven fracture data, which we have done, I think everyone would agree that you can extrapolate that data,” said Dr. Zaidi, director of the Mount Sinai Bone Program, Mount Sinai School of Medicine, New York.

Dr. Zaidi presented 2-year bone mineral density (BMD) data from the ibandronate Dosing Intravenous Administration trial, a Roche-sponsored phase III study that compared two doses of intravenous ibandronate (2 mg every 2 months and 3 mg every 3 months) with the approved oral dosing schedule (2.5 mg daily). The study group included 1,400 postmenopausal women with low bone mass (T-scores of −3.3 for total spine and −2 for hip).

After 2 years, BMD at the lumbar spine increased significantly more in both intravenous groups than in the oral group (mean increase 6.4% for the 2 mg IV dose, 6.3% for the 3 mg IV dose, and 4.8% for the oral dose).

BMD increased similarly at all other sites measured, with consistently greater gains in both intravenous groups than in the oral group, Dr. Zaidi said.

At 2 years, the incidence of adverse events was similar across all groups. Flulike illnesses and gastrointestinal intolerance were seen primarily in the first year, with only slight increases in cumulative numbers during the second year.

There was no osteonecrosis of the jaw. Renal and urinary incidents were uncommon and similar across groups.

Fracture incident, which was reported as an adverse event, was low and similar in all groups, although Dr. Zaidi stressed that the study was not powered to prove fracture risk reduction.

The intermittent dosing would also be “a great way” to ensure compliance, according to Dr. Zaidi.

BOSTON — Intermittent intravenous ibandronate is at least as effective as daily oral ibandronate for increasing bone mineral density and may be preferable to oral dosing in patients with esophageal disease or compliance problems.

There are no fracture data for the intravenous dosing schedule, but the risk reduction that has been shown with oral ibandronate can probably be extrapolated to the intravenous form of the drug, Dr. Mone Zaidi said at the annual meeting of the Endocrine Society.

Oral ibandronate has been shown to reduce the risk of new vertebral fractures by up to 60% (Curr. Med. Res. Opin. 2005;21:391–401; J. Bone Miner. Res. 2004;19:1241–9).

“If you can show equivalence or superiority in bone mineral density changes to [the form] with proven fracture data, which we have done, I think everyone would agree that you can extrapolate that data,” said Dr. Zaidi, director of the Mount Sinai Bone Program, Mount Sinai School of Medicine, New York.

Dr. Zaidi presented 2-year bone mineral density (BMD) data from the ibandronate Dosing Intravenous Administration trial, a Roche-sponsored phase III study that compared two doses of intravenous ibandronate (2 mg every 2 months and 3 mg every 3 months) with the approved oral dosing schedule (2.5 mg daily). The study group included 1,400 postmenopausal women with low bone mass (T-scores of −3.3 for total spine and −2 for hip).

After 2 years, BMD at the lumbar spine increased significantly more in both intravenous groups than in the oral group (mean increase 6.4% for the 2 mg IV dose, 6.3% for the 3 mg IV dose, and 4.8% for the oral dose).

BMD increased similarly at all other sites measured, with consistently greater gains in both intravenous groups than in the oral group, Dr. Zaidi said.

At 2 years, the incidence of adverse events was similar across all groups. Flulike illnesses and gastrointestinal intolerance were seen primarily in the first year, with only slight increases in cumulative numbers during the second year.

There was no osteonecrosis of the jaw. Renal and urinary incidents were uncommon and similar across groups.

Fracture incident, which was reported as an adverse event, was low and similar in all groups, although Dr. Zaidi stressed that the study was not powered to prove fracture risk reduction.

The intermittent dosing would also be “a great way” to ensure compliance, according to Dr. Zaidi.

BOSTON — The investigational antiresorptive denosumab is at least as effective as alendronate for increasing bone mineral density in postmenopausal women, Dr. Nelson Watts said at the annual meeting of the Endocrine Society.

The drug inhibits RANKL (receptor activator of nuclear factor kappa B ligand), which is a mediator of the resorptive phase of bone remodeling. Interfering with the binding of RANK to its ligand inhibits the differentiation and proliferation of osteoclasts, thus reducing bone turnover, said Dr. Watts, director of the bone health and osteoporosis center at the University of Cincinnati. He presented the 24-month bone mineral density (BMD) results of a phase II safety and efficacy trial of denosumab. The trial compared denosumab with open-label alendronate, 70 mg weekly, and placebo in 412 postmenopausal women with low bone mass. Three doses of denosumab were tested; Dr. Watts discussed the results for 60-mg doses given subcutaneously every 6 months. This dosage was selected for evaluation in phase III clinical testing.

At 24 months, denosumab was associated with a significantly higher mean increase in BMD than was alendronate at all skeletal sites measured, including lumbar spine (7% vs. 6%), total hip (5% vs. 3.5%), and distal radius (1.75% vs. 0.5%).

Adverse events occurred in about 93% of patients in both groups, and the types of events were not significantly different, with the exception of more dyspepsia among those taking alendronate, Dr. Watts said. There were no signs of increased immune problems, infections, or neoplasms in either group.

In a post hoc analysis, significantly more women in the denosumab group experienced a gain of more than 3% in BMD at each site measured, including lumbar spine (93% vs. 87%), total hip (80% vs. 56%), femoral neck (60% vs. 41%), and distal radius (25% vs. 11%).

The trial was sponsored by Amgen Inc., which manufactures denosumab.

BOSTON — The investigational antiresorptive denosumab is at least as effective as alendronate for increasing bone mineral density in postmenopausal women, Dr. Nelson Watts said at the annual meeting of the Endocrine Society.

The drug inhibits RANKL (receptor activator of nuclear factor kappa B ligand), which is a mediator of the resorptive phase of bone remodeling. Interfering with the binding of RANK to its ligand inhibits the differentiation and proliferation of osteoclasts, thus reducing bone turnover, said Dr. Watts, director of the bone health and osteoporosis center at the University of Cincinnati. He presented the 24-month bone mineral density (BMD) results of a phase II safety and efficacy trial of denosumab. The trial compared denosumab with open-label alendronate, 70 mg weekly, and placebo in 412 postmenopausal women with low bone mass. Three doses of denosumab were tested; Dr. Watts discussed the results for 60-mg doses given subcutaneously every 6 months. This dosage was selected for evaluation in phase III clinical testing.

At 24 months, denosumab was associated with a significantly higher mean increase in BMD than was alendronate at all skeletal sites measured, including lumbar spine (7% vs. 6%), total hip (5% vs. 3.5%), and distal radius (1.75% vs. 0.5%).

Adverse events occurred in about 93% of patients in both groups, and the types of events were not significantly different, with the exception of more dyspepsia among those taking alendronate, Dr. Watts said. There were no signs of increased immune problems, infections, or neoplasms in either group.

In a post hoc analysis, significantly more women in the denosumab group experienced a gain of more than 3% in BMD at each site measured, including lumbar spine (93% vs. 87%), total hip (80% vs. 56%), femoral neck (60% vs. 41%), and distal radius (25% vs. 11%).

The trial was sponsored by Amgen Inc., which manufactures denosumab.

BOSTON — The investigational antiresorptive denosumab is at least as effective as alendronate for increasing bone mineral density in postmenopausal women, Dr. Nelson Watts said at the annual meeting of the Endocrine Society.

The drug inhibits RANKL (receptor activator of nuclear factor kappa B ligand), which is a mediator of the resorptive phase of bone remodeling. Interfering with the binding of RANK to its ligand inhibits the differentiation and proliferation of osteoclasts, thus reducing bone turnover, said Dr. Watts, director of the bone health and osteoporosis center at the University of Cincinnati. He presented the 24-month bone mineral density (BMD) results of a phase II safety and efficacy trial of denosumab. The trial compared denosumab with open-label alendronate, 70 mg weekly, and placebo in 412 postmenopausal women with low bone mass. Three doses of denosumab were tested; Dr. Watts discussed the results for 60-mg doses given subcutaneously every 6 months. This dosage was selected for evaluation in phase III clinical testing.

At 24 months, denosumab was associated with a significantly higher mean increase in BMD than was alendronate at all skeletal sites measured, including lumbar spine (7% vs. 6%), total hip (5% vs. 3.5%), and distal radius (1.75% vs. 0.5%).

Adverse events occurred in about 93% of patients in both groups, and the types of events were not significantly different, with the exception of more dyspepsia among those taking alendronate, Dr. Watts said. There were no signs of increased immune problems, infections, or neoplasms in either group.

In a post hoc analysis, significantly more women in the denosumab group experienced a gain of more than 3% in BMD at each site measured, including lumbar spine (93% vs. 87%), total hip (80% vs. 56%), femoral neck (60% vs. 41%), and distal radius (25% vs. 11%).

The trial was sponsored by Amgen Inc., which manufactures denosumab.

SAN FRANCISCO — Teens who filled out a personal digital assistant health screen before their physician visit reported better communication with their doctor and higher overall satisfaction with their visit, Cecelia Gaffney said at the annual meeting of the Society of Behavioral Medicine.

The PDA screener is a good tool for organizing the adolescent visit, said Ms. Gaffney, a researcher at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

“Teens have a lot of things they want to discuss with their doctors, but most of them never get addressed during a typical 15-minute visit. We wanted to use technology to optimize the time physicians would have to discuss behavioral issues,” she said.

The project, funded by the Robert Wood Johnson Foundation as part of the national “Prescription for Health” program,” incorporated a 90-question adolescent health screen loaded onto PDAs.

The screen—based on the American Medical Association's Guidelines for Adolescent Preventive Services—also included questions about sports and cardiovascular risk, questions designed to assess readiness-to-change factors, a statement of confidentiality, and entertaining “health factoids” that popped up between questions. “Ninety questions is a lot, but most kids didn't have to answer all of them,” Ms. Gaffney said. The questions were branching, so if a teen answered “no” to a particular health risk, none of the related questions appeared.

The 8-month study included 1,024 adolescents, aged 11–19 years. In addition to completing the PDA screen, subjects also completed a survey before and after their physician visit.

The survey assessed factors such as how well teens felt their physician listened to them, how often they got to address all their topics of concern, and how confidential they felt their conversations were.

Physicians reviewed the results before seeing each patient.

About half of each group had one or two health risk factors. Three to five risk factors were present in 28% of 11- to 14-year-olds and in 35% of 15- to 19-year-olds. Only 21% of the younger group and 12% of the older group screened negative for any risk factors.

About one-third of the subjects screened positive for at least one symptom of depression.

The screen for the older group included a drug/alcohol risk assessment; 50% said they had used alcohol or drugs within the past month, and 15% screened positive for a potential drug or alcohol problem.

The screen showed that most subjects were getting adequate milk intake, but more than half didn't eat adequate amounts of fruits and vegetables.

Time spent watching television was higher in the younger group, whereas the older teens reported spending more time on the computer and playing video games.

The readiness-to-change assessment showed that most subjects were highly confident of their abilities to change health behaviors, even if they had never attempted any changes.

Exit surveys showed that the screener significantly increased the subjects' perceptions of communication and trust in their physician.

Before the visit, 63% said their physician listened well to them; after the visit, that number increased to 68%. The percentage who felt their doctor-patient conversation was confidential rose from 61% to 84%. Before the visit, 89% said they usually get to address all their concerns with their physician; after the visit, 98% said they discussed everything they wanted to.

The PDA also increased the number of adolescents who thought the physician was the right person to go to as a resource, Ms. Gaffney said.

Physicians involved in the study liked the PDA screener, she added.

“[Physicians] were able to give reinforcement for the positive behaviors the kids reported and focus more on the risk factors,” she said.

The conversation started at the beginning of the visit, so the physicians were able to spend more time counseling without making the visit longer.

SAN FRANCISCO — Teens who filled out a personal digital assistant health screen before their physician visit reported better communication with their doctor and higher overall satisfaction with their visit, Cecelia Gaffney said at the annual meeting of the Society of Behavioral Medicine.

The PDA screener is a good tool for organizing the adolescent visit, said Ms. Gaffney, a researcher at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

“Teens have a lot of things they want to discuss with their doctors, but most of them never get addressed during a typical 15-minute visit. We wanted to use technology to optimize the time physicians would have to discuss behavioral issues,” she said.

The project, funded by the Robert Wood Johnson Foundation as part of the national “Prescription for Health” program,” incorporated a 90-question adolescent health screen loaded onto PDAs.

The screen—based on the American Medical Association's Guidelines for Adolescent Preventive Services—also included questions about sports and cardiovascular risk, questions designed to assess readiness-to-change factors, a statement of confidentiality, and entertaining “health factoids” that popped up between questions. “Ninety questions is a lot, but most kids didn't have to answer all of them,” Ms. Gaffney said. The questions were branching, so if a teen answered “no” to a particular health risk, none of the related questions appeared.

The 8-month study included 1,024 adolescents, aged 11–19 years. In addition to completing the PDA screen, subjects also completed a survey before and after their physician visit.

The survey assessed factors such as how well teens felt their physician listened to them, how often they got to address all their topics of concern, and how confidential they felt their conversations were.

Physicians reviewed the results before seeing each patient.

About half of each group had one or two health risk factors. Three to five risk factors were present in 28% of 11- to 14-year-olds and in 35% of 15- to 19-year-olds. Only 21% of the younger group and 12% of the older group screened negative for any risk factors.

About one-third of the subjects screened positive for at least one symptom of depression.

The screen for the older group included a drug/alcohol risk assessment; 50% said they had used alcohol or drugs within the past month, and 15% screened positive for a potential drug or alcohol problem.

The screen showed that most subjects were getting adequate milk intake, but more than half didn't eat adequate amounts of fruits and vegetables.

Time spent watching television was higher in the younger group, whereas the older teens reported spending more time on the computer and playing video games.

The readiness-to-change assessment showed that most subjects were highly confident of their abilities to change health behaviors, even if they had never attempted any changes.

Exit surveys showed that the screener significantly increased the subjects' perceptions of communication and trust in their physician.

Before the visit, 63% said their physician listened well to them; after the visit, that number increased to 68%. The percentage who felt their doctor-patient conversation was confidential rose from 61% to 84%. Before the visit, 89% said they usually get to address all their concerns with their physician; after the visit, 98% said they discussed everything they wanted to.

The PDA also increased the number of adolescents who thought the physician was the right person to go to as a resource, Ms. Gaffney said.

Physicians involved in the study liked the PDA screener, she added.

“[Physicians] were able to give reinforcement for the positive behaviors the kids reported and focus more on the risk factors,” she said.

The conversation started at the beginning of the visit, so the physicians were able to spend more time counseling without making the visit longer.

SAN FRANCISCO — Teens who filled out a personal digital assistant health screen before their physician visit reported better communication with their doctor and higher overall satisfaction with their visit, Cecelia Gaffney said at the annual meeting of the Society of Behavioral Medicine.

The PDA screener is a good tool for organizing the adolescent visit, said Ms. Gaffney, a researcher at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

“Teens have a lot of things they want to discuss with their doctors, but most of them never get addressed during a typical 15-minute visit. We wanted to use technology to optimize the time physicians would have to discuss behavioral issues,” she said.

The project, funded by the Robert Wood Johnson Foundation as part of the national “Prescription for Health” program,” incorporated a 90-question adolescent health screen loaded onto PDAs.

The screen—based on the American Medical Association's Guidelines for Adolescent Preventive Services—also included questions about sports and cardiovascular risk, questions designed to assess readiness-to-change factors, a statement of confidentiality, and entertaining “health factoids” that popped up between questions. “Ninety questions is a lot, but most kids didn't have to answer all of them,” Ms. Gaffney said. The questions were branching, so if a teen answered “no” to a particular health risk, none of the related questions appeared.

The 8-month study included 1,024 adolescents, aged 11–19 years. In addition to completing the PDA screen, subjects also completed a survey before and after their physician visit.

The survey assessed factors such as how well teens felt their physician listened to them, how often they got to address all their topics of concern, and how confidential they felt their conversations were.

Physicians reviewed the results before seeing each patient.

About half of each group had one or two health risk factors. Three to five risk factors were present in 28% of 11- to 14-year-olds and in 35% of 15- to 19-year-olds. Only 21% of the younger group and 12% of the older group screened negative for any risk factors.

About one-third of the subjects screened positive for at least one symptom of depression.

The screen for the older group included a drug/alcohol risk assessment; 50% said they had used alcohol or drugs within the past month, and 15% screened positive for a potential drug or alcohol problem.

The screen showed that most subjects were getting adequate milk intake, but more than half didn't eat adequate amounts of fruits and vegetables.

Time spent watching television was higher in the younger group, whereas the older teens reported spending more time on the computer and playing video games.

The readiness-to-change assessment showed that most subjects were highly confident of their abilities to change health behaviors, even if they had never attempted any changes.

Exit surveys showed that the screener significantly increased the subjects' perceptions of communication and trust in their physician.

Before the visit, 63% said their physician listened well to them; after the visit, that number increased to 68%. The percentage who felt their doctor-patient conversation was confidential rose from 61% to 84%. Before the visit, 89% said they usually get to address all their concerns with their physician; after the visit, 98% said they discussed everything they wanted to.

The PDA also increased the number of adolescents who thought the physician was the right person to go to as a resource, Ms. Gaffney said.

Physicians involved in the study liked the PDA screener, she added.

“[Physicians] were able to give reinforcement for the positive behaviors the kids reported and focus more on the risk factors,” she said.

The conversation started at the beginning of the visit, so the physicians were able to spend more time counseling without making the visit longer.

BOSTON — Intensive treatment with multiple oral hypoglycemics and insulin can bring glucose and blood pressure levels within acceptable values in patients with poorly controlled type 2 diabetes, Dr. William Duckworth said at the annual meeting of the Endocrine Society.

Interim results of the 7-year Veterans Administration Diabetes Trial (VADT) also show that intensive therapy improved lipid levels and stabilized ophthalmic microvascular disease, said Dr. Duckworth, VADT's lead investigator and the director of diabetes research at the Carl T. Hayden Veterans Affairs Medical Center, Phoenix.

VADT will assess the impact of long-term intensive glucose control on cardiovascular and microvascular disease in 1,792 older patients who had poorly controlled type 2 diabetes at study entry and were randomized to standard or intensive therapy. At baseline, the patients' mean age was 60 years and mean duration of diabetes was 11.5 years. Mean hemoglobin A_1c level was 9.4%, mean body mass index was 30 kg/m

Both groups began therapy with metformin (for obese patients) or glimepiride (for lean patients). If their daily glucose goals were unmet, rosiglitazone was added, followed by insulin if necessary to achieve the goal. The major difference between the groups was the HbA_1c target: For the intensive treatment group, the target is 6% or less; for the standard treatment group, it is 8%–9%.

Within 1 year, the mean HbA_1c level fell to 7% in the intensive therapy group and to 8.5% in the standard therapy group. By year 4, the level in the intensive therapy group had decreased to 6.75%, but it remained steady in the standard therapy group. Also by year 4, almost all of the patients were on combination oral therapy, and the percentage on insulin had risen from 50% to 80%. The mean insulin dosage was 50 units/day in the intensive treatment group and 40 units/day in the standard treatment group.

“Surprisingly, the amount of insulin needed actually decreased from baseline in both groups, and it isn't all that much compared to what we usually think of as necessary in a group like this,” Dr. Duckworth said.

Blood pressure improved significantly by year 4 in both groups, he said, decreasing from a mean of 131/77 mm Hg to 125/70 mm Hg. Lipid profiles also improved in both groups: Triglycerides declined from 161 mg/dL to 143 mg/dL, LDL cholesterol was reduced from 104 mg/dL to 89 mg/dL, and HDL cholesterol rose from 34 mg/dL to 38 mg/dL. Albumin/creatinine levels did not significantly change from their mean baseline value of 70 mg/g.

Based on routine exams, retinopathy “hasn't gone away, but it certainly hasn't gotten any worse,” Dr. Duckworth said.

The trial is being supported by GlaxoSmithKline, Sanofi-Aventis, Novo Nordisk, and Roche Diagnostics as well as the Veterans Administration.

'Surprisingly, the amount of insulin needed actually decreased from baseline in both groups.' DR. DUCKWORTH

BOSTON — Intensive treatment with multiple oral hypoglycemics and insulin can bring glucose and blood pressure levels within acceptable values in patients with poorly controlled type 2 diabetes, Dr. William Duckworth said at the annual meeting of the Endocrine Society.

Interim results of the 7-year Veterans Administration Diabetes Trial (VADT) also show that intensive therapy improved lipid levels and stabilized ophthalmic microvascular disease, said Dr. Duckworth, VADT's lead investigator and the director of diabetes research at the Carl T. Hayden Veterans Affairs Medical Center, Phoenix.

VADT will assess the impact of long-term intensive glucose control on cardiovascular and microvascular disease in 1,792 older patients who had poorly controlled type 2 diabetes at study entry and were randomized to standard or intensive therapy. At baseline, the patients' mean age was 60 years and mean duration of diabetes was 11.5 years. Mean hemoglobin A_1c level was 9.4%, mean body mass index was 30 kg/m

Both groups began therapy with metformin (for obese patients) or glimepiride (for lean patients). If their daily glucose goals were unmet, rosiglitazone was added, followed by insulin if necessary to achieve the goal. The major difference between the groups was the HbA_1c target: For the intensive treatment group, the target is 6% or less; for the standard treatment group, it is 8%–9%.

Within 1 year, the mean HbA_1c level fell to 7% in the intensive therapy group and to 8.5% in the standard therapy group. By year 4, the level in the intensive therapy group had decreased to 6.75%, but it remained steady in the standard therapy group. Also by year 4, almost all of the patients were on combination oral therapy, and the percentage on insulin had risen from 50% to 80%. The mean insulin dosage was 50 units/day in the intensive treatment group and 40 units/day in the standard treatment group.

“Surprisingly, the amount of insulin needed actually decreased from baseline in both groups, and it isn't all that much compared to what we usually think of as necessary in a group like this,” Dr. Duckworth said.

Blood pressure improved significantly by year 4 in both groups, he said, decreasing from a mean of 131/77 mm Hg to 125/70 mm Hg. Lipid profiles also improved in both groups: Triglycerides declined from 161 mg/dL to 143 mg/dL, LDL cholesterol was reduced from 104 mg/dL to 89 mg/dL, and HDL cholesterol rose from 34 mg/dL to 38 mg/dL. Albumin/creatinine levels did not significantly change from their mean baseline value of 70 mg/g.

Based on routine exams, retinopathy “hasn't gone away, but it certainly hasn't gotten any worse,” Dr. Duckworth said.

The trial is being supported by GlaxoSmithKline, Sanofi-Aventis, Novo Nordisk, and Roche Diagnostics as well as the Veterans Administration.

'Surprisingly, the amount of insulin needed actually decreased from baseline in both groups.' DR. DUCKWORTH

BOSTON — Intensive treatment with multiple oral hypoglycemics and insulin can bring glucose and blood pressure levels within acceptable values in patients with poorly controlled type 2 diabetes, Dr. William Duckworth said at the annual meeting of the Endocrine Society.

Interim results of the 7-year Veterans Administration Diabetes Trial (VADT) also show that intensive therapy improved lipid levels and stabilized ophthalmic microvascular disease, said Dr. Duckworth, VADT's lead investigator and the director of diabetes research at the Carl T. Hayden Veterans Affairs Medical Center, Phoenix.

VADT will assess the impact of long-term intensive glucose control on cardiovascular and microvascular disease in 1,792 older patients who had poorly controlled type 2 diabetes at study entry and were randomized to standard or intensive therapy. At baseline, the patients' mean age was 60 years and mean duration of diabetes was 11.5 years. Mean hemoglobin A_1c level was 9.4%, mean body mass index was 30 kg/m

Both groups began therapy with metformin (for obese patients) or glimepiride (for lean patients). If their daily glucose goals were unmet, rosiglitazone was added, followed by insulin if necessary to achieve the goal. The major difference between the groups was the HbA_1c target: For the intensive treatment group, the target is 6% or less; for the standard treatment group, it is 8%–9%.

Within 1 year, the mean HbA_1c level fell to 7% in the intensive therapy group and to 8.5% in the standard therapy group. By year 4, the level in the intensive therapy group had decreased to 6.75%, but it remained steady in the standard therapy group. Also by year 4, almost all of the patients were on combination oral therapy, and the percentage on insulin had risen from 50% to 80%. The mean insulin dosage was 50 units/day in the intensive treatment group and 40 units/day in the standard treatment group.

“Surprisingly, the amount of insulin needed actually decreased from baseline in both groups, and it isn't all that much compared to what we usually think of as necessary in a group like this,” Dr. Duckworth said.

Blood pressure improved significantly by year 4 in both groups, he said, decreasing from a mean of 131/77 mm Hg to 125/70 mm Hg. Lipid profiles also improved in both groups: Triglycerides declined from 161 mg/dL to 143 mg/dL, LDL cholesterol was reduced from 104 mg/dL to 89 mg/dL, and HDL cholesterol rose from 34 mg/dL to 38 mg/dL. Albumin/creatinine levels did not significantly change from their mean baseline value of 70 mg/g.

Based on routine exams, retinopathy “hasn't gone away, but it certainly hasn't gotten any worse,” Dr. Duckworth said.

The trial is being supported by GlaxoSmithKline, Sanofi-Aventis, Novo Nordisk, and Roche Diagnostics as well as the Veterans Administration.

'Surprisingly, the amount of insulin needed actually decreased from baseline in both groups.' DR. DUCKWORTH

MADRID – Rivastigmine should be the first option for treating dementia and associated behavioral symptoms in Parkinson's disease, with the atypical antipsychotics reserved for unresponsive patients, Dr. Murat Emre said at the 10th International Conference for Alzheimer's Disease and Related Disorders.

“There is evidence from our studies and from other, smaller studies that behavioral symptoms can improve with cholinergic treatment,” said Dr. Emre, a professor of neurology at the University of Istanbul (Turkey).

“If the symptoms are not massive, acute, or destructive, and are combined with dementia, the wise thing is to first try a cholinesterase inhibitor, because the atypical antipsychotics are associated with an increased risk of cerebrovascular or cardiovascular events.”

Up to 78% of Parkinson's patients eventually will develop dementia, Dr. Emre said. The prototypic syndrome consists of impaired or fluctuating attention and lessened visuospatial and executive function. There may be moderate memory impairment, although language is usually preserved. Depression, apathy, delusions, and hallucinations also can occur.

Clozapine and quetiapine are often prescribed for these symptoms in Parkinson's patients, Dr. Emre said. However, these drugs, like all atypical antipsychotics, carry a black box warning of increased mortality in elderly patients with dementia. The Food and Drug Administration, which reviewed 17 studies before issuing the warning, said most of the excess deaths were cardiovascular or infectious.

Because Parkinson's, like Alzheimer's, is a disease of the cholinergic system, cholinesterase inhibitors are a sound alternative for Parkinson's dementia, Dr. Emre said. Many small studies–all with fewer than 30 patients–have investigated the use of anticholinergics in Parkinson's dementia, concluding that the drugs can improve cognition without further impairing motor function. Only one large, placebo-controlled, randomized trial has addressed the issue, however.

That 2004 study by Dr. Emre and colleagues randomized 541 patients to either rivastigmine (titrated from 3 mg to 12 mg over 16 weeks) or placebo for 24 weeks. The trial found significant improvements in cognition, activities of daily living, and clinical impression among the active group, compared with the placebo group (N. Engl. J. Med. 2004;351:2509–18).

There were significantly more adverse events in the group on active treatment than in the placebo group, most of which were mild to moderate gastrointestinal upset. However, 10% of patients on active treatment did experience new or worsening tremor.

A 12-month follow-up crossover trial assessed the long-term effects of the drug. Published this year, the study concluded that rivastigmine maintained efficacy over time in the original group on active treatment, and that placebo patients switched to the drug showed improvements similar to those seen in the trial's initial group on active treatment (Mov. Disord. 2006;21:456–61).

However, the lag time for the original placebo patients did affect their improvements.

MADRID – Rivastigmine should be the first option for treating dementia and associated behavioral symptoms in Parkinson's disease, with the atypical antipsychotics reserved for unresponsive patients, Dr. Murat Emre said at the 10th International Conference for Alzheimer's Disease and Related Disorders.

“There is evidence from our studies and from other, smaller studies that behavioral symptoms can improve with cholinergic treatment,” said Dr. Emre, a professor of neurology at the University of Istanbul (Turkey).

“If the symptoms are not massive, acute, or destructive, and are combined with dementia, the wise thing is to first try a cholinesterase inhibitor, because the atypical antipsychotics are associated with an increased risk of cerebrovascular or cardiovascular events.”

Up to 78% of Parkinson's patients eventually will develop dementia, Dr. Emre said. The prototypic syndrome consists of impaired or fluctuating attention and lessened visuospatial and executive function. There may be moderate memory impairment, although language is usually preserved. Depression, apathy, delusions, and hallucinations also can occur.

Clozapine and quetiapine are often prescribed for these symptoms in Parkinson's patients, Dr. Emre said. However, these drugs, like all atypical antipsychotics, carry a black box warning of increased mortality in elderly patients with dementia. The Food and Drug Administration, which reviewed 17 studies before issuing the warning, said most of the excess deaths were cardiovascular or infectious.

Because Parkinson's, like Alzheimer's, is a disease of the cholinergic system, cholinesterase inhibitors are a sound alternative for Parkinson's dementia, Dr. Emre said. Many small studies–all with fewer than 30 patients–have investigated the use of anticholinergics in Parkinson's dementia, concluding that the drugs can improve cognition without further impairing motor function. Only one large, placebo-controlled, randomized trial has addressed the issue, however.

That 2004 study by Dr. Emre and colleagues randomized 541 patients to either rivastigmine (titrated from 3 mg to 12 mg over 16 weeks) or placebo for 24 weeks. The trial found significant improvements in cognition, activities of daily living, and clinical impression among the active group, compared with the placebo group (N. Engl. J. Med. 2004;351:2509–18).

There were significantly more adverse events in the group on active treatment than in the placebo group, most of which were mild to moderate gastrointestinal upset. However, 10% of patients on active treatment did experience new or worsening tremor.

A 12-month follow-up crossover trial assessed the long-term effects of the drug. Published this year, the study concluded that rivastigmine maintained efficacy over time in the original group on active treatment, and that placebo patients switched to the drug showed improvements similar to those seen in the trial's initial group on active treatment (Mov. Disord. 2006;21:456–61).

However, the lag time for the original placebo patients did affect their improvements.

MADRID – Rivastigmine should be the first option for treating dementia and associated behavioral symptoms in Parkinson's disease, with the atypical antipsychotics reserved for unresponsive patients, Dr. Murat Emre said at the 10th International Conference for Alzheimer's Disease and Related Disorders.

“There is evidence from our studies and from other, smaller studies that behavioral symptoms can improve with cholinergic treatment,” said Dr. Emre, a professor of neurology at the University of Istanbul (Turkey).

“If the symptoms are not massive, acute, or destructive, and are combined with dementia, the wise thing is to first try a cholinesterase inhibitor, because the atypical antipsychotics are associated with an increased risk of cerebrovascular or cardiovascular events.”

Up to 78% of Parkinson's patients eventually will develop dementia, Dr. Emre said. The prototypic syndrome consists of impaired or fluctuating attention and lessened visuospatial and executive function. There may be moderate memory impairment, although language is usually preserved. Depression, apathy, delusions, and hallucinations also can occur.

Clozapine and quetiapine are often prescribed for these symptoms in Parkinson's patients, Dr. Emre said. However, these drugs, like all atypical antipsychotics, carry a black box warning of increased mortality in elderly patients with dementia. The Food and Drug Administration, which reviewed 17 studies before issuing the warning, said most of the excess deaths were cardiovascular or infectious.

Because Parkinson's, like Alzheimer's, is a disease of the cholinergic system, cholinesterase inhibitors are a sound alternative for Parkinson's dementia, Dr. Emre said. Many small studies–all with fewer than 30 patients–have investigated the use of anticholinergics in Parkinson's dementia, concluding that the drugs can improve cognition without further impairing motor function. Only one large, placebo-controlled, randomized trial has addressed the issue, however.

That 2004 study by Dr. Emre and colleagues randomized 541 patients to either rivastigmine (titrated from 3 mg to 12 mg over 16 weeks) or placebo for 24 weeks. The trial found significant improvements in cognition, activities of daily living, and clinical impression among the active group, compared with the placebo group (N. Engl. J. Med. 2004;351:2509–18).

There were significantly more adverse events in the group on active treatment than in the placebo group, most of which were mild to moderate gastrointestinal upset. However, 10% of patients on active treatment did experience new or worsening tremor.

A 12-month follow-up crossover trial assessed the long-term effects of the drug. Published this year, the study concluded that rivastigmine maintained efficacy over time in the original group on active treatment, and that placebo patients switched to the drug showed improvements similar to those seen in the trial's initial group on active treatment (Mov. Disord. 2006;21:456–61).

However, the lag time for the original placebo patients did affect their improvements.

MADRID – PIB-PET imaging not only differentiated patients with mild cognitive impairment and Alzheimer's disease from normal controls, but it also identified amyloid pathology in subjects who did not yet express cognitive symptoms, according to findings from a small study.

The unexpected finding may have a huge effect on two of neurologists' dream goals: to identify patients destined to develop the disorder, and to initiate treatment that would avert or minimize its cognitive consequences, according to speakers at the 10th International Conference on Alzheimer's Disease and Related Disorders.

Dr. Steven T. DeKosky, chairman of the department of neurology at the University of Pittsburgh, used PIB-PET imaging (PET with Pittsburgh Compound-B) and a radiotracer known as [18F]FDDNP to examine plaque deposition and the progression of amyloid plaques and neurofibrillary tangles in 59 subjects, of whom 14 had mild cognitive impairment (MCI), 14 had confirmed Alzheimer's disease, and 31 were age-matched controls. Both compounds bind to amyloid A, allowing scans to track the progression of plaques and neurofibrillary tangling in the brain.

The scan successfully separated Alzheimer's patients from controls with no overlap. The patients had about twice the amyloid deposition.

The differentiations between subjects with MCI and controls–as well as between MCI subjects and Alzheimer's patients–were not as clear cut, however. “About 25% of our controls actually had some plaque binding, and 60% of our MCI subjects already had enough binding to put them in the Alzheimer's category,” Dr. DeKosky said.

Interestingly, the amyloid burden in MCI subjects didn't necessarily correlate with cognitive function, Dr. DeKosky noted. “We had one MCI subject with very high binding but a very good Mini-Mental State [Examination] score, and one MCI subject who had very low binding, nearer to control levels, who had a very poor MMSE.”

Dr. Gary Small, director of the memory and aging research center at the University of California, Los Angeles, used [18F]FDDNP not only to differentiate normal brains from those with MCI and Alzheimer's disease, but also to track the progression of the disorder.

His study involved 60 subjects (mean age 71 years): 20 controls, 20 with MCI, and 20 with Alzheimer's disease. All of the subjects received an [18F]FDDNP PET scan, and 12 had repeat scans 2 years later.

The scans clearly separated the groups with no overlap between the controls and the patients with Alzheimer's disease. But 60% of those with MCI had amyloid binding in the mediotemporal lobe that was of similar volume to that seen in Alzheimer's patients. “We also saw that some controls were beginning to show amyloid buildup in this area,” Dr. Small said.

Follow-up scans were performed 2 years later on eight controls and four MCI subjects. Amyloid binding was stable in those who remained cognitively stable. But in those who declined cognitively–that is, going either from normal to MCI status, or from MCI to Alzheimer's disease–amyloid binding increased 5%–11% compared with their baseline scan.

The main difference between the compounds–as both are highly accurate in distinguishing the populations–seems to be the length of their activity, Dr. Small said: [18F]FDDNP has a 2-hour half-life, whereas the half-life of PIB is only 20 minutes.

The current lack of a sensitive and accurate diagnostic method greatly impedes both treatment and research, said Dr. Ronald Petersen, who moderated a press conference at the meeting, which was presented by the Alzheimer's Association.

“Tests that would track the progression of the disease would help us treat people earlier and greatly speed testing of new drugs in treatment trials,” said Dr. Petersen, a spokesman for the association. “Imaging may be the solution, because it can help us look inside the brain and body to diagnose the disease, monitor progression and track the effects of therapy,” he said.

The scans clearly separated the groups, with no overlap between the controls and the Alzheimer's patients. DR. SMALL

These PIB-PET images show FDDNP binding to amyloid plaques in normal, MCI, and Alzheimer's brains. Arrows show lateral temporal and mediotemporal lobes. Courtesy Dr. Gary Small

MADRID – PIB-PET imaging not only differentiated patients with mild cognitive impairment and Alzheimer's disease from normal controls, but it also identified amyloid pathology in subjects who did not yet express cognitive symptoms, according to findings from a small study.

The unexpected finding may have a huge effect on two of neurologists' dream goals: to identify patients destined to develop the disorder, and to initiate treatment that would avert or minimize its cognitive consequences, according to speakers at the 10th International Conference on Alzheimer's Disease and Related Disorders.

Dr. Steven T. DeKosky, chairman of the department of neurology at the University of Pittsburgh, used PIB-PET imaging (PET with Pittsburgh Compound-B) and a radiotracer known as [18F]FDDNP to examine plaque deposition and the progression of amyloid plaques and neurofibrillary tangles in 59 subjects, of whom 14 had mild cognitive impairment (MCI), 14 had confirmed Alzheimer's disease, and 31 were age-matched controls. Both compounds bind to amyloid A, allowing scans to track the progression of plaques and neurofibrillary tangling in the brain.

The scan successfully separated Alzheimer's patients from controls with no overlap. The patients had about twice the amyloid deposition.

The differentiations between subjects with MCI and controls–as well as between MCI subjects and Alzheimer's patients–were not as clear cut, however. “About 25% of our controls actually had some plaque binding, and 60% of our MCI subjects already had enough binding to put them in the Alzheimer's category,” Dr. DeKosky said.

Interestingly, the amyloid burden in MCI subjects didn't necessarily correlate with cognitive function, Dr. DeKosky noted. “We had one MCI subject with very high binding but a very good Mini-Mental State [Examination] score, and one MCI subject who had very low binding, nearer to control levels, who had a very poor MMSE.”

Dr. Gary Small, director of the memory and aging research center at the University of California, Los Angeles, used [18F]FDDNP not only to differentiate normal brains from those with MCI and Alzheimer's disease, but also to track the progression of the disorder.

His study involved 60 subjects (mean age 71 years): 20 controls, 20 with MCI, and 20 with Alzheimer's disease. All of the subjects received an [18F]FDDNP PET scan, and 12 had repeat scans 2 years later.

The scans clearly separated the groups with no overlap between the controls and the patients with Alzheimer's disease. But 60% of those with MCI had amyloid binding in the mediotemporal lobe that was of similar volume to that seen in Alzheimer's patients. “We also saw that some controls were beginning to show amyloid buildup in this area,” Dr. Small said.

Follow-up scans were performed 2 years later on eight controls and four MCI subjects. Amyloid binding was stable in those who remained cognitively stable. But in those who declined cognitively–that is, going either from normal to MCI status, or from MCI to Alzheimer's disease–amyloid binding increased 5%–11% compared with their baseline scan.

The main difference between the compounds–as both are highly accurate in distinguishing the populations–seems to be the length of their activity, Dr. Small said: [18F]FDDNP has a 2-hour half-life, whereas the half-life of PIB is only 20 minutes.

The current lack of a sensitive and accurate diagnostic method greatly impedes both treatment and research, said Dr. Ronald Petersen, who moderated a press conference at the meeting, which was presented by the Alzheimer's Association.

“Tests that would track the progression of the disease would help us treat people earlier and greatly speed testing of new drugs in treatment trials,” said Dr. Petersen, a spokesman for the association. “Imaging may be the solution, because it can help us look inside the brain and body to diagnose the disease, monitor progression and track the effects of therapy,” he said.

The scans clearly separated the groups, with no overlap between the controls and the Alzheimer's patients. DR. SMALL

These PIB-PET images show FDDNP binding to amyloid plaques in normal, MCI, and Alzheimer's brains. Arrows show lateral temporal and mediotemporal lobes. Courtesy Dr. Gary Small

MADRID – PIB-PET imaging not only differentiated patients with mild cognitive impairment and Alzheimer's disease from normal controls, but it also identified amyloid pathology in subjects who did not yet express cognitive symptoms, according to findings from a small study.

The unexpected finding may have a huge effect on two of neurologists' dream goals: to identify patients destined to develop the disorder, and to initiate treatment that would avert or minimize its cognitive consequences, according to speakers at the 10th International Conference on Alzheimer's Disease and Related Disorders.

Dr. Steven T. DeKosky, chairman of the department of neurology at the University of Pittsburgh, used PIB-PET imaging (PET with Pittsburgh Compound-B) and a radiotracer known as [18F]FDDNP to examine plaque deposition and the progression of amyloid plaques and neurofibrillary tangles in 59 subjects, of whom 14 had mild cognitive impairment (MCI), 14 had confirmed Alzheimer's disease, and 31 were age-matched controls. Both compounds bind to amyloid A, allowing scans to track the progression of plaques and neurofibrillary tangling in the brain.

The scan successfully separated Alzheimer's patients from controls with no overlap. The patients had about twice the amyloid deposition.

The differentiations between subjects with MCI and controls–as well as between MCI subjects and Alzheimer's patients–were not as clear cut, however. “About 25% of our controls actually had some plaque binding, and 60% of our MCI subjects already had enough binding to put them in the Alzheimer's category,” Dr. DeKosky said.

Interestingly, the amyloid burden in MCI subjects didn't necessarily correlate with cognitive function, Dr. DeKosky noted. “We had one MCI subject with very high binding but a very good Mini-Mental State [Examination] score, and one MCI subject who had very low binding, nearer to control levels, who had a very poor MMSE.”

Dr. Gary Small, director of the memory and aging research center at the University of California, Los Angeles, used [18F]FDDNP not only to differentiate normal brains from those with MCI and Alzheimer's disease, but also to track the progression of the disorder.

His study involved 60 subjects (mean age 71 years): 20 controls, 20 with MCI, and 20 with Alzheimer's disease. All of the subjects received an [18F]FDDNP PET scan, and 12 had repeat scans 2 years later.

The scans clearly separated the groups with no overlap between the controls and the patients with Alzheimer's disease. But 60% of those with MCI had amyloid binding in the mediotemporal lobe that was of similar volume to that seen in Alzheimer's patients. “We also saw that some controls were beginning to show amyloid buildup in this area,” Dr. Small said.

Follow-up scans were performed 2 years later on eight controls and four MCI subjects. Amyloid binding was stable in those who remained cognitively stable. But in those who declined cognitively–that is, going either from normal to MCI status, or from MCI to Alzheimer's disease–amyloid binding increased 5%–11% compared with their baseline scan.

The main difference between the compounds–as both are highly accurate in distinguishing the populations–seems to be the length of their activity, Dr. Small said: [18F]FDDNP has a 2-hour half-life, whereas the half-life of PIB is only 20 minutes.

The current lack of a sensitive and accurate diagnostic method greatly impedes both treatment and research, said Dr. Ronald Petersen, who moderated a press conference at the meeting, which was presented by the Alzheimer's Association.

“Tests that would track the progression of the disease would help us treat people earlier and greatly speed testing of new drugs in treatment trials,” said Dr. Petersen, a spokesman for the association. “Imaging may be the solution, because it can help us look inside the brain and body to diagnose the disease, monitor progression and track the effects of therapy,” he said.

The scans clearly separated the groups, with no overlap between the controls and the Alzheimer's patients. DR. SMALL

These PIB-PET images show FDDNP binding to amyloid plaques in normal, MCI, and Alzheimer's brains. Arrows show lateral temporal and mediotemporal lobes. Courtesy Dr. Gary Small