Michele G. Sullivan

DESTIN, FLA. — Investigational antiresorptive agents with novel methods of action and dosing regimens may improve patient compliance and persistence, but will not reduce the risk of fracture associated with osteoporosis beyond that seen with current agents.

“The objective of all these drugs is to normalize bone turnover, which we already do extraordinarily well and easily with bisphosphonates,” Dr. Michael McClung said at a rheumatology meeting sponsored by the Virginia Commonwealth University.

However, some of the investigational antiresorptives are just as good at increasing bone mineral density as are the bisphosphonates, and may be easier for patients to take, he added.

Denosumab, currently in phase III studies, has shown some promising effects. The agent inhibits the binding of the RANK protein to its ligand. The binding increases the population of osteoclasts and allows them to live longer, inhibiting the binding blocks that process, thus reducing bone turnover.

A phase II study compared different denosumab doses to placebo and to alendronate. It found that denosumab increased bone density as well or better than alendronate, especially at sites greater in cortical bone. Denosumab reduced serum C-telopeptide levels more than did alendronate. Within 3 days of initiating therapy, the levels dropped 80% with all doses of denosumab, compared with 25% with alendronate (N. Engl. J. Med. 2006;354:821–31).

The drug was well tolerated, said Dr. McClung, director of the Oregon Osteoporosis Center, Portland, and principal investigator of the study. There were no injection site reactions or adverse events that increased with dosage, and no observed immune response problems, he said at the meeting, also sponsored by the International Society for Clinical Densitometry and the Alabama Chapter of the Arthritis Foundation. The phase III study is looking at the effects of a 60-mg subcutaneous dose once every 6 months.

Intravenous bisphosphonates given every few months avoid the gastrointestinal side effects and could improve persistence in therapy. They will be especially convenient for nursing home residents, Dr. McClung said.

Ibandronate was recently approved for intravenous dosing of 3 mg every 3 months. A trial showed that bone mineral density and bone turnover marker responses to this dose were similar to those achieved with daily oral dosing of 2.5 mg. There are no fracture data available for the new dosing schedule, but a previous study showed that infusions of 0.5 or 1 mg of ibandronate every 3 months did not persistently suppress markers of bone turnover and did not significantly reduce fracture risk. (Bone 2004;34:890–9).

Intravenous zoledronic acid, already approved in 4-mg doses for the treatment of cancer-related bone diseases, is now being studied for an osteoporosis indication. A phase II study demonstrated that a single dose of 4 mg IV suppressed indices of bone turnover for at least 12 months. A phase III study is exploring yearly infusions of 5 mg IV zoledronic acid for the treatment of osteoporosis.

Cathepsin K inhibitors are also being investigated in phase II trials, he said. Cathepsin K is an enzyme required for hydrolysis of the bone matrix, inhibiting the enzyme reduces bone resorption.

Several new selective estrogen receptor modulators are also under investigation. “I don't think anyone has found the magic SERM that is as potent as estrogen on the skeleton, but without the problematic side effects,” said Dr. McClung.

Strontium ranelate is an interesting compound being investigated in Europe. The orally administered strontium salt is taken up in bone much the same way as is calcium; however, it is denser than calcium. It has been shown to reduce the risk of vertebral and nonvertebral fracture in older women with osteoporosis. It is available in several counties, but there are no immediate plans to market the drug in the United States.

New anabolic or bone-forming agents are also being studied. Parathyroid hormone 1–84 has been shown to increase bone formation and to reduce the risk of vertebral fractures in women with osteoporosis. The drug is under consideration by the Food and Drug Administration.

In animal studies, an antibody that binds sclerostin, an inhibitor of osteoblast activity, normalized bone mass and the deterioration of bone structure that occurred after estrogen deficiency.

“The availability of new agents will provide important new options for both clinicians and our patients,” said Dr. McClung. “Importantly, we may find new combinations of antiresorptive and anabolic agents that provide additive effects and, perhaps, even the cure for osteoporosis.”

DESTIN, FLA. — Investigational antiresorptive agents with novel methods of action and dosing regimens may improve patient compliance and persistence, but will not reduce the risk of fracture associated with osteoporosis beyond that seen with current agents.

“The objective of all these drugs is to normalize bone turnover, which we already do extraordinarily well and easily with bisphosphonates,” Dr. Michael McClung said at a rheumatology meeting sponsored by the Virginia Commonwealth University.

However, some of the investigational antiresorptives are just as good at increasing bone mineral density as are the bisphosphonates, and may be easier for patients to take, he added.

Denosumab, currently in phase III studies, has shown some promising effects. The agent inhibits the binding of the RANK protein to its ligand. The binding increases the population of osteoclasts and allows them to live longer, inhibiting the binding blocks that process, thus reducing bone turnover.

A phase II study compared different denosumab doses to placebo and to alendronate. It found that denosumab increased bone density as well or better than alendronate, especially at sites greater in cortical bone. Denosumab reduced serum C-telopeptide levels more than did alendronate. Within 3 days of initiating therapy, the levels dropped 80% with all doses of denosumab, compared with 25% with alendronate (N. Engl. J. Med. 2006;354:821–31).

The drug was well tolerated, said Dr. McClung, director of the Oregon Osteoporosis Center, Portland, and principal investigator of the study. There were no injection site reactions or adverse events that increased with dosage, and no observed immune response problems, he said at the meeting, also sponsored by the International Society for Clinical Densitometry and the Alabama Chapter of the Arthritis Foundation. The phase III study is looking at the effects of a 60-mg subcutaneous dose once every 6 months.

Intravenous bisphosphonates given every few months avoid the gastrointestinal side effects and could improve persistence in therapy. They will be especially convenient for nursing home residents, Dr. McClung said.

Ibandronate was recently approved for intravenous dosing of 3 mg every 3 months. A trial showed that bone mineral density and bone turnover marker responses to this dose were similar to those achieved with daily oral dosing of 2.5 mg. There are no fracture data available for the new dosing schedule, but a previous study showed that infusions of 0.5 or 1 mg of ibandronate every 3 months did not persistently suppress markers of bone turnover and did not significantly reduce fracture risk. (Bone 2004;34:890–9).

Intravenous zoledronic acid, already approved in 4-mg doses for the treatment of cancer-related bone diseases, is now being studied for an osteoporosis indication. A phase II study demonstrated that a single dose of 4 mg IV suppressed indices of bone turnover for at least 12 months. A phase III study is exploring yearly infusions of 5 mg IV zoledronic acid for the treatment of osteoporosis.

Cathepsin K inhibitors are also being investigated in phase II trials, he said. Cathepsin K is an enzyme required for hydrolysis of the bone matrix, inhibiting the enzyme reduces bone resorption.

Several new selective estrogen receptor modulators are also under investigation. “I don't think anyone has found the magic SERM that is as potent as estrogen on the skeleton, but without the problematic side effects,” said Dr. McClung.

Strontium ranelate is an interesting compound being investigated in Europe. The orally administered strontium salt is taken up in bone much the same way as is calcium; however, it is denser than calcium. It has been shown to reduce the risk of vertebral and nonvertebral fracture in older women with osteoporosis. It is available in several counties, but there are no immediate plans to market the drug in the United States.

New anabolic or bone-forming agents are also being studied. Parathyroid hormone 1–84 has been shown to increase bone formation and to reduce the risk of vertebral fractures in women with osteoporosis. The drug is under consideration by the Food and Drug Administration.

In animal studies, an antibody that binds sclerostin, an inhibitor of osteoblast activity, normalized bone mass and the deterioration of bone structure that occurred after estrogen deficiency.

“The availability of new agents will provide important new options for both clinicians and our patients,” said Dr. McClung. “Importantly, we may find new combinations of antiresorptive and anabolic agents that provide additive effects and, perhaps, even the cure for osteoporosis.”

DESTIN, FLA. — Investigational antiresorptive agents with novel methods of action and dosing regimens may improve patient compliance and persistence, but will not reduce the risk of fracture associated with osteoporosis beyond that seen with current agents.

“The objective of all these drugs is to normalize bone turnover, which we already do extraordinarily well and easily with bisphosphonates,” Dr. Michael McClung said at a rheumatology meeting sponsored by the Virginia Commonwealth University.

However, some of the investigational antiresorptives are just as good at increasing bone mineral density as are the bisphosphonates, and may be easier for patients to take, he added.

Denosumab, currently in phase III studies, has shown some promising effects. The agent inhibits the binding of the RANK protein to its ligand. The binding increases the population of osteoclasts and allows them to live longer, inhibiting the binding blocks that process, thus reducing bone turnover.

A phase II study compared different denosumab doses to placebo and to alendronate. It found that denosumab increased bone density as well or better than alendronate, especially at sites greater in cortical bone. Denosumab reduced serum C-telopeptide levels more than did alendronate. Within 3 days of initiating therapy, the levels dropped 80% with all doses of denosumab, compared with 25% with alendronate (N. Engl. J. Med. 2006;354:821–31).

The drug was well tolerated, said Dr. McClung, director of the Oregon Osteoporosis Center, Portland, and principal investigator of the study. There were no injection site reactions or adverse events that increased with dosage, and no observed immune response problems, he said at the meeting, also sponsored by the International Society for Clinical Densitometry and the Alabama Chapter of the Arthritis Foundation. The phase III study is looking at the effects of a 60-mg subcutaneous dose once every 6 months.

Intravenous bisphosphonates given every few months avoid the gastrointestinal side effects and could improve persistence in therapy. They will be especially convenient for nursing home residents, Dr. McClung said.

Ibandronate was recently approved for intravenous dosing of 3 mg every 3 months. A trial showed that bone mineral density and bone turnover marker responses to this dose were similar to those achieved with daily oral dosing of 2.5 mg. There are no fracture data available for the new dosing schedule, but a previous study showed that infusions of 0.5 or 1 mg of ibandronate every 3 months did not persistently suppress markers of bone turnover and did not significantly reduce fracture risk. (Bone 2004;34:890–9).

Intravenous zoledronic acid, already approved in 4-mg doses for the treatment of cancer-related bone diseases, is now being studied for an osteoporosis indication. A phase II study demonstrated that a single dose of 4 mg IV suppressed indices of bone turnover for at least 12 months. A phase III study is exploring yearly infusions of 5 mg IV zoledronic acid for the treatment of osteoporosis.

Cathepsin K inhibitors are also being investigated in phase II trials, he said. Cathepsin K is an enzyme required for hydrolysis of the bone matrix, inhibiting the enzyme reduces bone resorption.

Several new selective estrogen receptor modulators are also under investigation. “I don't think anyone has found the magic SERM that is as potent as estrogen on the skeleton, but without the problematic side effects,” said Dr. McClung.

Strontium ranelate is an interesting compound being investigated in Europe. The orally administered strontium salt is taken up in bone much the same way as is calcium; however, it is denser than calcium. It has been shown to reduce the risk of vertebral and nonvertebral fracture in older women with osteoporosis. It is available in several counties, but there are no immediate plans to market the drug in the United States.

New anabolic or bone-forming agents are also being studied. Parathyroid hormone 1–84 has been shown to increase bone formation and to reduce the risk of vertebral fractures in women with osteoporosis. The drug is under consideration by the Food and Drug Administration.

In animal studies, an antibody that binds sclerostin, an inhibitor of osteoblast activity, normalized bone mass and the deterioration of bone structure that occurred after estrogen deficiency.

“The availability of new agents will provide important new options for both clinicians and our patients,” said Dr. McClung. “Importantly, we may find new combinations of antiresorptive and anabolic agents that provide additive effects and, perhaps, even the cure for osteoporosis.”

Most patients with diabetic peripheral neuropathic pain will experience significant relief and improved quality of life when treated with tricyclic antidepressants, duloxetine, controlled-release oxycodone, pregabalin, or a combination of these agents, according to new treatment guidelines issued by the American Society of Pain Educators.

Treatment strategies should begin with these drugs, which have already been proved effective in the disorder, and take into account physical and psychiatric comorbidities, adverse event profiles, and cost, according to the guidelines (Mayo Clin. Proc. 2006;81[4 Suppl]:S12–25).

Almost all patients with diabetic peripheral neuropathic pain (DPNP) will improve if they and their physicians are patient and persistent, said Dr. B. Eliot Cole, executive director of the American Society of Pain Educators and chairman of the panel that created the guidelines.

Problems arise when both parties become frustrated over nonresponsiveness to initial therapies, Dr. Cole said. Overcoming this attitude will go a long way toward improving treatment outcomes. Since the approval of several agents specifically for treatment of DPNP, and with the judicious use of older agents, DPNP is far from being the untreatable problem many believe it to be, he said in an interview.

If the first treatment doesn't work, another probably will. It is also important to instill realistic expectations, noted Dr. Cole. “Of course our goal is always 100% freedom from pain, but the reality is that most patients probably won't experience that. We can, however, put together plans that are easy to follow and have low side effects, which significantly increase compliance and the chances of pain control.”

Undertreatment is probably the biggest obstacle to success, he said. “The majority of diabetics with pain are taking over-the-counter nonsteroidal anti-inflammatories as their primary form of treatment. Many physicians might not know that those drugs are totally ineffective for DPNP.”

Even those who receive prescriptions appear to be undertreated, according to a 2004 study cited in the guidelines. Of 55,686 DPNP patients, 53% were getting only a short-acting opioid and 40% an NSAID. Other commonly prescribed drugs included benzodiazepines and SSRIs (J. Pain 2004;5:143–9), neither of which are effective for neuropathic pain, said Dr. Cole.

In constructing the guidelines, the committee reviewed 120 drug studies published in 1995–2005. The studies included those specific to DPNP as well as studies of other neuropathic pain conditions.

Duloxetine, controlled-release oxycodone, pregabalin, and tricyclic antidepressants, having the strongest evidence of efficacy, are the committee's first-tier drug treatment choices, each having more than two positive randomized, controlled trials specific for DPNP, according to the new guidelines.

Duloxetine and pregabalin are the only drugs approved for DPNP. With duloxetine, more than 50% of patients can expect at least a 50% decrease in pain. Its effects are rapid, usually occurring within 1 week. Advantages include once-daily dosing and antidepressant efficacy.

The guidelines go on to note that pregabalin, especially at its higher doses, can decrease pain by 70% or greater in at least 30% of patients, and by 50% in at least 50% of patients. Patients should notice its effects within 1 week. Side effects of somnolence and dizziness can be bothersome, however.

The tricyclics amitriptyline and desipramine are also effective, although they are not tolerated as well as duloxetine, according to the guidelines. In two DPNP trials, controlled-release oxycodone significantly reduced all measures of pain. However, it's important to evaluate each patient's potential for abuse before prescribing the drug.

Second-tier agents—with one randomized, controlled trial for DPNP and at least one trial in another painful neuropathy—include carbamazepine, gabapentin, lamotrigine, tramadol, and extended-release venlafaxine.

The guidelines committee also reviewed the evidence for topical treatments (capsaicin and lidocaine) and the evidence for bupropion, citalopram, methadone, paroxetine, phenytoin, and topiramate, none of which have been studied for treating DPNP. However, each has at least one randomized, controlled trial in other painful neuropathies.

To reap maximum benefit, first-tier agents should be aggressively dosed, but physicians shouldn't waste a lot of time waiting for results, according to the guidelines. “First-tier agents should be titrated to maximum tolerated dose. A reduction in pain of at least 50% from baseline should be expected if the agent is effective for that patient.” If there are no significant results by 3 weeks, a modification of therapy is warranted.

Once therapy is initiated, patients should undergo regular follow-up. “Patients must be asked at each visit whether their pain is improved and, if so, to what degree. … If they are not satisfied with the treatment effect, they should be offered the option to add therapy, along with an explanation that they may receive more relief at the expense of more potential adverse events,” according to the guidelines.

When adding an agent, it's best to prescribe a drug that has a different method of action rather than just adding another similar drug, Dr. Cole said. “We're looking for the synergistic effect, not the additive effect. We hope 1 plus 1 will equal 3.”

The guidelines will be a valuable resource not only for neurologists, but also for family physicians, internists, and psychiatrists, all of whom are called upon to treat DPNP in a busy clinical practice—a venue that makes it tough to give these patients the time and attention they need, he said.

“Pregabalin and duloxetine are very easy to work with,” Dr. Cole said. “They have one starting dose; you follow an easy progression of titration, and within 2–4 weeks, you know if it's going to be effective. It doesn't take 6 months to know if you're on the right track, and that's very helpful for a busy clinician.”

Dr. Cole receives honoraria from Eli Lilly & Co. and Endo Pharmaceuticals.

Most patients with diabetic peripheral neuropathic pain will experience significant relief and improved quality of life when treated with tricyclic antidepressants, duloxetine, controlled-release oxycodone, pregabalin, or a combination of these agents, according to new treatment guidelines issued by the American Society of Pain Educators.

Treatment strategies should begin with these drugs, which have already been proved effective in the disorder, and take into account physical and psychiatric comorbidities, adverse event profiles, and cost, according to the guidelines (Mayo Clin. Proc. 2006;81[4 Suppl]:S12–25).

Almost all patients with diabetic peripheral neuropathic pain (DPNP) will improve if they and their physicians are patient and persistent, said Dr. B. Eliot Cole, executive director of the American Society of Pain Educators and chairman of the panel that created the guidelines.

Problems arise when both parties become frustrated over nonresponsiveness to initial therapies, Dr. Cole said. Overcoming this attitude will go a long way toward improving treatment outcomes. Since the approval of several agents specifically for treatment of DPNP, and with the judicious use of older agents, DPNP is far from being the untreatable problem many believe it to be, he said in an interview.

If the first treatment doesn't work, another probably will. It is also important to instill realistic expectations, noted Dr. Cole. “Of course our goal is always 100% freedom from pain, but the reality is that most patients probably won't experience that. We can, however, put together plans that are easy to follow and have low side effects, which significantly increase compliance and the chances of pain control.”

Undertreatment is probably the biggest obstacle to success, he said. “The majority of diabetics with pain are taking over-the-counter nonsteroidal anti-inflammatories as their primary form of treatment. Many physicians might not know that those drugs are totally ineffective for DPNP.”

Even those who receive prescriptions appear to be undertreated, according to a 2004 study cited in the guidelines. Of 55,686 DPNP patients, 53% were getting only a short-acting opioid and 40% an NSAID. Other commonly prescribed drugs included benzodiazepines and SSRIs (J. Pain 2004;5:143–9), neither of which are effective for neuropathic pain, said Dr. Cole.

In constructing the guidelines, the committee reviewed 120 drug studies published in 1995–2005. The studies included those specific to DPNP as well as studies of other neuropathic pain conditions.

Duloxetine, controlled-release oxycodone, pregabalin, and tricyclic antidepressants, having the strongest evidence of efficacy, are the committee's first-tier drug treatment choices, each having more than two positive randomized, controlled trials specific for DPNP, according to the new guidelines.

Duloxetine and pregabalin are the only drugs approved for DPNP. With duloxetine, more than 50% of patients can expect at least a 50% decrease in pain. Its effects are rapid, usually occurring within 1 week. Advantages include once-daily dosing and antidepressant efficacy.

The guidelines go on to note that pregabalin, especially at its higher doses, can decrease pain by 70% or greater in at least 30% of patients, and by 50% in at least 50% of patients. Patients should notice its effects within 1 week. Side effects of somnolence and dizziness can be bothersome, however.

The tricyclics amitriptyline and desipramine are also effective, although they are not tolerated as well as duloxetine, according to the guidelines. In two DPNP trials, controlled-release oxycodone significantly reduced all measures of pain. However, it's important to evaluate each patient's potential for abuse before prescribing the drug.

Second-tier agents—with one randomized, controlled trial for DPNP and at least one trial in another painful neuropathy—include carbamazepine, gabapentin, lamotrigine, tramadol, and extended-release venlafaxine.

The guidelines committee also reviewed the evidence for topical treatments (capsaicin and lidocaine) and the evidence for bupropion, citalopram, methadone, paroxetine, phenytoin, and topiramate, none of which have been studied for treating DPNP. However, each has at least one randomized, controlled trial in other painful neuropathies.

To reap maximum benefit, first-tier agents should be aggressively dosed, but physicians shouldn't waste a lot of time waiting for results, according to the guidelines. “First-tier agents should be titrated to maximum tolerated dose. A reduction in pain of at least 50% from baseline should be expected if the agent is effective for that patient.” If there are no significant results by 3 weeks, a modification of therapy is warranted.

Once therapy is initiated, patients should undergo regular follow-up. “Patients must be asked at each visit whether their pain is improved and, if so, to what degree. … If they are not satisfied with the treatment effect, they should be offered the option to add therapy, along with an explanation that they may receive more relief at the expense of more potential adverse events,” according to the guidelines.

When adding an agent, it's best to prescribe a drug that has a different method of action rather than just adding another similar drug, Dr. Cole said. “We're looking for the synergistic effect, not the additive effect. We hope 1 plus 1 will equal 3.”

The guidelines will be a valuable resource not only for neurologists, but also for family physicians, internists, and psychiatrists, all of whom are called upon to treat DPNP in a busy clinical practice—a venue that makes it tough to give these patients the time and attention they need, he said.

“Pregabalin and duloxetine are very easy to work with,” Dr. Cole said. “They have one starting dose; you follow an easy progression of titration, and within 2–4 weeks, you know if it's going to be effective. It doesn't take 6 months to know if you're on the right track, and that's very helpful for a busy clinician.”

Dr. Cole receives honoraria from Eli Lilly & Co. and Endo Pharmaceuticals.

Most patients with diabetic peripheral neuropathic pain will experience significant relief and improved quality of life when treated with tricyclic antidepressants, duloxetine, controlled-release oxycodone, pregabalin, or a combination of these agents, according to new treatment guidelines issued by the American Society of Pain Educators.

Treatment strategies should begin with these drugs, which have already been proved effective in the disorder, and take into account physical and psychiatric comorbidities, adverse event profiles, and cost, according to the guidelines (Mayo Clin. Proc. 2006;81[4 Suppl]:S12–25).

Almost all patients with diabetic peripheral neuropathic pain (DPNP) will improve if they and their physicians are patient and persistent, said Dr. B. Eliot Cole, executive director of the American Society of Pain Educators and chairman of the panel that created the guidelines.

Problems arise when both parties become frustrated over nonresponsiveness to initial therapies, Dr. Cole said. Overcoming this attitude will go a long way toward improving treatment outcomes. Since the approval of several agents specifically for treatment of DPNP, and with the judicious use of older agents, DPNP is far from being the untreatable problem many believe it to be, he said in an interview.

If the first treatment doesn't work, another probably will. It is also important to instill realistic expectations, noted Dr. Cole. “Of course our goal is always 100% freedom from pain, but the reality is that most patients probably won't experience that. We can, however, put together plans that are easy to follow and have low side effects, which significantly increase compliance and the chances of pain control.”

Undertreatment is probably the biggest obstacle to success, he said. “The majority of diabetics with pain are taking over-the-counter nonsteroidal anti-inflammatories as their primary form of treatment. Many physicians might not know that those drugs are totally ineffective for DPNP.”

Even those who receive prescriptions appear to be undertreated, according to a 2004 study cited in the guidelines. Of 55,686 DPNP patients, 53% were getting only a short-acting opioid and 40% an NSAID. Other commonly prescribed drugs included benzodiazepines and SSRIs (J. Pain 2004;5:143–9), neither of which are effective for neuropathic pain, said Dr. Cole.

In constructing the guidelines, the committee reviewed 120 drug studies published in 1995–2005. The studies included those specific to DPNP as well as studies of other neuropathic pain conditions.

Duloxetine, controlled-release oxycodone, pregabalin, and tricyclic antidepressants, having the strongest evidence of efficacy, are the committee's first-tier drug treatment choices, each having more than two positive randomized, controlled trials specific for DPNP, according to the new guidelines.

Duloxetine and pregabalin are the only drugs approved for DPNP. With duloxetine, more than 50% of patients can expect at least a 50% decrease in pain. Its effects are rapid, usually occurring within 1 week. Advantages include once-daily dosing and antidepressant efficacy.

The guidelines go on to note that pregabalin, especially at its higher doses, can decrease pain by 70% or greater in at least 30% of patients, and by 50% in at least 50% of patients. Patients should notice its effects within 1 week. Side effects of somnolence and dizziness can be bothersome, however.

The tricyclics amitriptyline and desipramine are also effective, although they are not tolerated as well as duloxetine, according to the guidelines. In two DPNP trials, controlled-release oxycodone significantly reduced all measures of pain. However, it's important to evaluate each patient's potential for abuse before prescribing the drug.

Second-tier agents—with one randomized, controlled trial for DPNP and at least one trial in another painful neuropathy—include carbamazepine, gabapentin, lamotrigine, tramadol, and extended-release venlafaxine.

The guidelines committee also reviewed the evidence for topical treatments (capsaicin and lidocaine) and the evidence for bupropion, citalopram, methadone, paroxetine, phenytoin, and topiramate, none of which have been studied for treating DPNP. However, each has at least one randomized, controlled trial in other painful neuropathies.

To reap maximum benefit, first-tier agents should be aggressively dosed, but physicians shouldn't waste a lot of time waiting for results, according to the guidelines. “First-tier agents should be titrated to maximum tolerated dose. A reduction in pain of at least 50% from baseline should be expected if the agent is effective for that patient.” If there are no significant results by 3 weeks, a modification of therapy is warranted.

Once therapy is initiated, patients should undergo regular follow-up. “Patients must be asked at each visit whether their pain is improved and, if so, to what degree. … If they are not satisfied with the treatment effect, they should be offered the option to add therapy, along with an explanation that they may receive more relief at the expense of more potential adverse events,” according to the guidelines.

When adding an agent, it's best to prescribe a drug that has a different method of action rather than just adding another similar drug, Dr. Cole said. “We're looking for the synergistic effect, not the additive effect. We hope 1 plus 1 will equal 3.”

The guidelines will be a valuable resource not only for neurologists, but also for family physicians, internists, and psychiatrists, all of whom are called upon to treat DPNP in a busy clinical practice—a venue that makes it tough to give these patients the time and attention they need, he said.

“Pregabalin and duloxetine are very easy to work with,” Dr. Cole said. “They have one starting dose; you follow an easy progression of titration, and within 2–4 weeks, you know if it's going to be effective. It doesn't take 6 months to know if you're on the right track, and that's very helpful for a busy clinician.”

Dr. Cole receives honoraria from Eli Lilly & Co. and Endo Pharmaceuticals.

SAN FRANCISCO – Rape appears to initiate a host of neuroinflammatory changes that could predispose the victim to later inflammatory disease, Maureen Groer, Ph.D., said at the annual meeting of the Society of Behavioral Medicine.

“Victims of rape experience more headaches, chronic pain, gastrointestinal disorders, breast cancer, and arthritis–many of which have an inflammatory component,” said Dr. Groer, a registered nurse at the University of South Florida, Tampa. “About a third of them also develop posttraumatic stress disorder, which is also associated with an increase in inflammatory disorders.

“I would suggest that this could be explained by psychoneuroimmunology, in which stressors appear to provoke an immune response that can lead to damage of normal tissues if it is prolonged.”

To examine the relationship between rape and inflammatory response, Dr. Groer compared lymphocyte counts and cytokine and hormone levels in a group of 16 healthy control women who had low self-reported stress with those in a group of 15 victims of recent, first-time rape. Blood was collected from the rape victims within 72 hours of their assault (most within 24 hours). The rape victims' mean age was 30 years; that of the control group was 24 years. None of the women were living in domestic abuse or violent situations.

Serum analysis revealed that levels of CD8 cytotoxic cells were significantly higher in rape victims than in controls (10% vs. 6%), and CD19 percentages were significantly lower in rape victims compared with controls (6% vs. 20%).

Compared with controls, rape victims also expressed much higher levels of interferon-γ (10 times higher), interleukin-10 (four times higher), interleukin-6 (five times higher), and C-reactive protein (three times higher). These data suggest an acute inflammatory process.

Nurses who examined the rape victims also noted victims' behavior as controlled (quiet and withdrawn) or uncontrolled (angry or lashing out). Most of the victims were controlled; control correlated with lower CD4 counts, reduced CD4/CD8 ratios, and lower lymphocyte proliferation. “This suggests a state of T-cell suppression,” Dr. Groer said. “The inflammatory response system may dominate and deplete the adaptive resources of the women, and provoke a pathophysiologic state leading to multiple adverse health outcomes.”

SAN FRANCISCO – Rape appears to initiate a host of neuroinflammatory changes that could predispose the victim to later inflammatory disease, Maureen Groer, Ph.D., said at the annual meeting of the Society of Behavioral Medicine.

“Victims of rape experience more headaches, chronic pain, gastrointestinal disorders, breast cancer, and arthritis–many of which have an inflammatory component,” said Dr. Groer, a registered nurse at the University of South Florida, Tampa. “About a third of them also develop posttraumatic stress disorder, which is also associated with an increase in inflammatory disorders.

“I would suggest that this could be explained by psychoneuroimmunology, in which stressors appear to provoke an immune response that can lead to damage of normal tissues if it is prolonged.”

To examine the relationship between rape and inflammatory response, Dr. Groer compared lymphocyte counts and cytokine and hormone levels in a group of 16 healthy control women who had low self-reported stress with those in a group of 15 victims of recent, first-time rape. Blood was collected from the rape victims within 72 hours of their assault (most within 24 hours). The rape victims' mean age was 30 years; that of the control group was 24 years. None of the women were living in domestic abuse or violent situations.

Serum analysis revealed that levels of CD8 cytotoxic cells were significantly higher in rape victims than in controls (10% vs. 6%), and CD19 percentages were significantly lower in rape victims compared with controls (6% vs. 20%).

Compared with controls, rape victims also expressed much higher levels of interferon-γ (10 times higher), interleukin-10 (four times higher), interleukin-6 (five times higher), and C-reactive protein (three times higher). These data suggest an acute inflammatory process.

Nurses who examined the rape victims also noted victims' behavior as controlled (quiet and withdrawn) or uncontrolled (angry or lashing out). Most of the victims were controlled; control correlated with lower CD4 counts, reduced CD4/CD8 ratios, and lower lymphocyte proliferation. “This suggests a state of T-cell suppression,” Dr. Groer said. “The inflammatory response system may dominate and deplete the adaptive resources of the women, and provoke a pathophysiologic state leading to multiple adverse health outcomes.”

SAN FRANCISCO – Rape appears to initiate a host of neuroinflammatory changes that could predispose the victim to later inflammatory disease, Maureen Groer, Ph.D., said at the annual meeting of the Society of Behavioral Medicine.

“Victims of rape experience more headaches, chronic pain, gastrointestinal disorders, breast cancer, and arthritis–many of which have an inflammatory component,” said Dr. Groer, a registered nurse at the University of South Florida, Tampa. “About a third of them also develop posttraumatic stress disorder, which is also associated with an increase in inflammatory disorders.

“I would suggest that this could be explained by psychoneuroimmunology, in which stressors appear to provoke an immune response that can lead to damage of normal tissues if it is prolonged.”

To examine the relationship between rape and inflammatory response, Dr. Groer compared lymphocyte counts and cytokine and hormone levels in a group of 16 healthy control women who had low self-reported stress with those in a group of 15 victims of recent, first-time rape. Blood was collected from the rape victims within 72 hours of their assault (most within 24 hours). The rape victims' mean age was 30 years; that of the control group was 24 years. None of the women were living in domestic abuse or violent situations.

Serum analysis revealed that levels of CD8 cytotoxic cells were significantly higher in rape victims than in controls (10% vs. 6%), and CD19 percentages were significantly lower in rape victims compared with controls (6% vs. 20%).

Compared with controls, rape victims also expressed much higher levels of interferon-γ (10 times higher), interleukin-10 (four times higher), interleukin-6 (five times higher), and C-reactive protein (three times higher). These data suggest an acute inflammatory process.

Nurses who examined the rape victims also noted victims' behavior as controlled (quiet and withdrawn) or uncontrolled (angry or lashing out). Most of the victims were controlled; control correlated with lower CD4 counts, reduced CD4/CD8 ratios, and lower lymphocyte proliferation. “This suggests a state of T-cell suppression,” Dr. Groer said. “The inflammatory response system may dominate and deplete the adaptive resources of the women, and provoke a pathophysiologic state leading to multiple adverse health outcomes.”

SAN FRANCISCO – Hospitalization may provide a unique opportunity to offer counseling to patients with alcohol problems.

“As a result of an acute medical event, many patients have a high motivation to change their drinking behavior,” Jennis Freyer, Ph.D., said in an interview. “Hospitalization offers the chance to reach patients with alcohol-attributable disease proactively.”

In a poster presented at the annual meeting of the Society of Behavioral Medicine, Dr. Freyer assessed openness to alcohol counseling in patients who stayed more than 24 hours in one of four German hospitals. Screening with the Munich-Composite International Diagnostic Interview identified 1,150 patients with alcohol problems. She assessed the severity of the alcohol problem with the Alcohol Use Disorders Identification Test and mental health with the Rand Mental Health Index.

Most of the patients (93%) were male; the mean age was 42 years. Dependence was the most frequently identified alcohol problem (49%), followed by alcohol abuse (12%), at-risk drinking (30%), and episodic heavy drinking (9%). The mean Alcohol Use Disorders Identification Test score was 19; the mean Mental Health Index score was 7.

She assessed the patients' openness for counseling by using a simple two-item true-false survey (“I'm open to learn more about help” and “I want to find out how to help myself”). Patients then completed the Readiness to Change Questionnaire and the Treatment Readiness Tool.

Overall, 66% of the patients were open to the idea of alcohol counseling. More of those with alcohol dependence were open to counseling than those with alcohol abuse or at-risk drinking (77% vs. 56%).

“Those with alcohol dependence are more likely to have developed problem recognition,” said Dr. Freyer of the University of Greifswald, Germany. “Having identified alcohol as being part of their problem may increase their openness for counseling, especially when they feel helpless about their situation.”

However, she noted, more than half of risky drinkers and those with alcohol dependence were still open to the idea of getting counseling.

In the Readiness to Change scale, those in the contemplation stage were twice as likely to be open to counseling as were those in the precontemplation stage. In the Treatment Readiness assessment, those in the contemplation stage were nine times more likely to accept counseling than were those in the precontemplation stage.

SAN FRANCISCO – Hospitalization may provide a unique opportunity to offer counseling to patients with alcohol problems.

“As a result of an acute medical event, many patients have a high motivation to change their drinking behavior,” Jennis Freyer, Ph.D., said in an interview. “Hospitalization offers the chance to reach patients with alcohol-attributable disease proactively.”

In a poster presented at the annual meeting of the Society of Behavioral Medicine, Dr. Freyer assessed openness to alcohol counseling in patients who stayed more than 24 hours in one of four German hospitals. Screening with the Munich-Composite International Diagnostic Interview identified 1,150 patients with alcohol problems. She assessed the severity of the alcohol problem with the Alcohol Use Disorders Identification Test and mental health with the Rand Mental Health Index.

Most of the patients (93%) were male; the mean age was 42 years. Dependence was the most frequently identified alcohol problem (49%), followed by alcohol abuse (12%), at-risk drinking (30%), and episodic heavy drinking (9%). The mean Alcohol Use Disorders Identification Test score was 19; the mean Mental Health Index score was 7.

She assessed the patients' openness for counseling by using a simple two-item true-false survey (“I'm open to learn more about help” and “I want to find out how to help myself”). Patients then completed the Readiness to Change Questionnaire and the Treatment Readiness Tool.

Overall, 66% of the patients were open to the idea of alcohol counseling. More of those with alcohol dependence were open to counseling than those with alcohol abuse or at-risk drinking (77% vs. 56%).

“Those with alcohol dependence are more likely to have developed problem recognition,” said Dr. Freyer of the University of Greifswald, Germany. “Having identified alcohol as being part of their problem may increase their openness for counseling, especially when they feel helpless about their situation.”

However, she noted, more than half of risky drinkers and those with alcohol dependence were still open to the idea of getting counseling.

In the Readiness to Change scale, those in the contemplation stage were twice as likely to be open to counseling as were those in the precontemplation stage. In the Treatment Readiness assessment, those in the contemplation stage were nine times more likely to accept counseling than were those in the precontemplation stage.

SAN FRANCISCO – Hospitalization may provide a unique opportunity to offer counseling to patients with alcohol problems.

“As a result of an acute medical event, many patients have a high motivation to change their drinking behavior,” Jennis Freyer, Ph.D., said in an interview. “Hospitalization offers the chance to reach patients with alcohol-attributable disease proactively.”

In a poster presented at the annual meeting of the Society of Behavioral Medicine, Dr. Freyer assessed openness to alcohol counseling in patients who stayed more than 24 hours in one of four German hospitals. Screening with the Munich-Composite International Diagnostic Interview identified 1,150 patients with alcohol problems. She assessed the severity of the alcohol problem with the Alcohol Use Disorders Identification Test and mental health with the Rand Mental Health Index.

Most of the patients (93%) were male; the mean age was 42 years. Dependence was the most frequently identified alcohol problem (49%), followed by alcohol abuse (12%), at-risk drinking (30%), and episodic heavy drinking (9%). The mean Alcohol Use Disorders Identification Test score was 19; the mean Mental Health Index score was 7.

She assessed the patients' openness for counseling by using a simple two-item true-false survey (“I'm open to learn more about help” and “I want to find out how to help myself”). Patients then completed the Readiness to Change Questionnaire and the Treatment Readiness Tool.

Overall, 66% of the patients were open to the idea of alcohol counseling. More of those with alcohol dependence were open to counseling than those with alcohol abuse or at-risk drinking (77% vs. 56%).

“Those with alcohol dependence are more likely to have developed problem recognition,” said Dr. Freyer of the University of Greifswald, Germany. “Having identified alcohol as being part of their problem may increase their openness for counseling, especially when they feel helpless about their situation.”

However, she noted, more than half of risky drinkers and those with alcohol dependence were still open to the idea of getting counseling.

In the Readiness to Change scale, those in the contemplation stage were twice as likely to be open to counseling as were those in the precontemplation stage. In the Treatment Readiness assessment, those in the contemplation stage were nine times more likely to accept counseling than were those in the precontemplation stage.

SAN FRANCISCO – A behavioral medicine program of play combined with stress reduction and management techniques significantly reduced symptoms of posttraumatic stress disorder in a group of children whose community had been decimated by two consecutive hurricanes.

Play is a natural healing force for children, Carmen Russoniello, Ph.D., said at the annual meeting of the Society of Behavioral Medicine. “We believed that since recreation is inherently healing, we could perhaps meld it into a structured program that would help these kids learn to cope with what had happened to their school and community.”

In 1999, two consecutive hurricanes flooded eastern North Carolina, destroying homes and schools; 51 people died. Dr. Russoniello, director of the psychophysiology and biofeedback lab at East Carolina University, Greenville, N.C., created the program in response to pleas from school administrators in one of the flood-devastated communities. Their elementary school was destroyed; all the students were relocated to trailer classrooms near the federal disaster management site.

“These children had lost their school, and almost 40% had their homes flooded,” he said. Many of the children watched helicopters flying in and out of the community rescuing their families and feared that they would die. “They had experienced a terrifying event,” he said.

It was a perfect opportunity not only to try and help the children cope with their experience but also to study posttraumatic stress disorder (PTSD) in children–an area that has received little attention.

“Until rather recently, we thought PTSD didn't occur in children,” he said. “We now know that it does and that the symptoms can have devastating effects on their health and performance, including depression and anxiety, and school and social problems.”

The intervention began with a baseline assessment of PTSD symptoms in the school's fourth graders, 6 months after the hurricanes hit, said Susan McGhee, Ph.D., also of East Carolina University. In the group of 150 children (mean age 9.5 years), PTSD (as measured by the Posttraumatic Stress Reaction Index, child version) was very severe in 9%, severe in 25%, and moderate in 36%.

Another one-quarter had mild symptoms, while the diagnosis was doubtful in about 5%. All of the children reported symptoms of reexperiencing; 85% reported symptoms of hyperarousal; and 64% reported symptoms of numbing/avoidance. Symptoms were worse in girls and in children whose homes had been flooded.

The intervention consisted of five weekly hour-long sessions. Each session opened with a recreational activity, which was followed by a 20-minute learning session that focused on stress reduction or management, including overview of childhood stress, positive thinking, deep breathing and relaxation, stress-reduction activities, and emotional regulation.

Each session closed with more play, during which children were encouraged to use the techniques they had just learned.

Postintervention assessment showed a significant decline in PTSD symptoms. Only 3% had very severe symptoms, while symptoms were severe in 22%, moderate in 30%, mild in 28%, and doubtful in 15%. There were significant reductions in reexperiencing and numbing/avoidance, but hyperarousal symptoms were resistant, especially in boys.

The program also affected the children's coping mechanisms, as measured by the KidCope checklist. Children reported less blaming of themselves, less withdrawal into television watching, less anger and lashing out, and being less likely to try and fix the problem.

Dr. Russoniello and Dr. McGhee designed the behavioral intervention, but it was delivered at the school by students of the university's recreational therapy program. Using college students had unexpected benefits, Dr. Russoniello said. “The children bonded with them instantly, perhaps because they were closer in age or because they could see the possibility of their own future success in them.”

The college students also gained valuable professional experience and proved their worth as an asset in times of emergency. “When we are responding to large-scale disasters, there aren't enough professionals to go around,” he said. “This study showed us that trained college students might be able to fill some of these gaps.”

SAN FRANCISCO – A behavioral medicine program of play combined with stress reduction and management techniques significantly reduced symptoms of posttraumatic stress disorder in a group of children whose community had been decimated by two consecutive hurricanes.

Play is a natural healing force for children, Carmen Russoniello, Ph.D., said at the annual meeting of the Society of Behavioral Medicine. “We believed that since recreation is inherently healing, we could perhaps meld it into a structured program that would help these kids learn to cope with what had happened to their school and community.”

In 1999, two consecutive hurricanes flooded eastern North Carolina, destroying homes and schools; 51 people died. Dr. Russoniello, director of the psychophysiology and biofeedback lab at East Carolina University, Greenville, N.C., created the program in response to pleas from school administrators in one of the flood-devastated communities. Their elementary school was destroyed; all the students were relocated to trailer classrooms near the federal disaster management site.

“These children had lost their school, and almost 40% had their homes flooded,” he said. Many of the children watched helicopters flying in and out of the community rescuing their families and feared that they would die. “They had experienced a terrifying event,” he said.

It was a perfect opportunity not only to try and help the children cope with their experience but also to study posttraumatic stress disorder (PTSD) in children–an area that has received little attention.

“Until rather recently, we thought PTSD didn't occur in children,” he said. “We now know that it does and that the symptoms can have devastating effects on their health and performance, including depression and anxiety, and school and social problems.”

The intervention began with a baseline assessment of PTSD symptoms in the school's fourth graders, 6 months after the hurricanes hit, said Susan McGhee, Ph.D., also of East Carolina University. In the group of 150 children (mean age 9.5 years), PTSD (as measured by the Posttraumatic Stress Reaction Index, child version) was very severe in 9%, severe in 25%, and moderate in 36%.

Another one-quarter had mild symptoms, while the diagnosis was doubtful in about 5%. All of the children reported symptoms of reexperiencing; 85% reported symptoms of hyperarousal; and 64% reported symptoms of numbing/avoidance. Symptoms were worse in girls and in children whose homes had been flooded.

The intervention consisted of five weekly hour-long sessions. Each session opened with a recreational activity, which was followed by a 20-minute learning session that focused on stress reduction or management, including overview of childhood stress, positive thinking, deep breathing and relaxation, stress-reduction activities, and emotional regulation.

Each session closed with more play, during which children were encouraged to use the techniques they had just learned.

Postintervention assessment showed a significant decline in PTSD symptoms. Only 3% had very severe symptoms, while symptoms were severe in 22%, moderate in 30%, mild in 28%, and doubtful in 15%. There were significant reductions in reexperiencing and numbing/avoidance, but hyperarousal symptoms were resistant, especially in boys.

The program also affected the children's coping mechanisms, as measured by the KidCope checklist. Children reported less blaming of themselves, less withdrawal into television watching, less anger and lashing out, and being less likely to try and fix the problem.

Dr. Russoniello and Dr. McGhee designed the behavioral intervention, but it was delivered at the school by students of the university's recreational therapy program. Using college students had unexpected benefits, Dr. Russoniello said. “The children bonded with them instantly, perhaps because they were closer in age or because they could see the possibility of their own future success in them.”

The college students also gained valuable professional experience and proved their worth as an asset in times of emergency. “When we are responding to large-scale disasters, there aren't enough professionals to go around,” he said. “This study showed us that trained college students might be able to fill some of these gaps.”

SAN FRANCISCO – A behavioral medicine program of play combined with stress reduction and management techniques significantly reduced symptoms of posttraumatic stress disorder in a group of children whose community had been decimated by two consecutive hurricanes.

Play is a natural healing force for children, Carmen Russoniello, Ph.D., said at the annual meeting of the Society of Behavioral Medicine. “We believed that since recreation is inherently healing, we could perhaps meld it into a structured program that would help these kids learn to cope with what had happened to their school and community.”

In 1999, two consecutive hurricanes flooded eastern North Carolina, destroying homes and schools; 51 people died. Dr. Russoniello, director of the psychophysiology and biofeedback lab at East Carolina University, Greenville, N.C., created the program in response to pleas from school administrators in one of the flood-devastated communities. Their elementary school was destroyed; all the students were relocated to trailer classrooms near the federal disaster management site.

“These children had lost their school, and almost 40% had their homes flooded,” he said. Many of the children watched helicopters flying in and out of the community rescuing their families and feared that they would die. “They had experienced a terrifying event,” he said.

It was a perfect opportunity not only to try and help the children cope with their experience but also to study posttraumatic stress disorder (PTSD) in children–an area that has received little attention.

“Until rather recently, we thought PTSD didn't occur in children,” he said. “We now know that it does and that the symptoms can have devastating effects on their health and performance, including depression and anxiety, and school and social problems.”

The intervention began with a baseline assessment of PTSD symptoms in the school's fourth graders, 6 months after the hurricanes hit, said Susan McGhee, Ph.D., also of East Carolina University. In the group of 150 children (mean age 9.5 years), PTSD (as measured by the Posttraumatic Stress Reaction Index, child version) was very severe in 9%, severe in 25%, and moderate in 36%.

Another one-quarter had mild symptoms, while the diagnosis was doubtful in about 5%. All of the children reported symptoms of reexperiencing; 85% reported symptoms of hyperarousal; and 64% reported symptoms of numbing/avoidance. Symptoms were worse in girls and in children whose homes had been flooded.

The intervention consisted of five weekly hour-long sessions. Each session opened with a recreational activity, which was followed by a 20-minute learning session that focused on stress reduction or management, including overview of childhood stress, positive thinking, deep breathing and relaxation, stress-reduction activities, and emotional regulation.

Each session closed with more play, during which children were encouraged to use the techniques they had just learned.

Postintervention assessment showed a significant decline in PTSD symptoms. Only 3% had very severe symptoms, while symptoms were severe in 22%, moderate in 30%, mild in 28%, and doubtful in 15%. There were significant reductions in reexperiencing and numbing/avoidance, but hyperarousal symptoms were resistant, especially in boys.

The program also affected the children's coping mechanisms, as measured by the KidCope checklist. Children reported less blaming of themselves, less withdrawal into television watching, less anger and lashing out, and being less likely to try and fix the problem.

Dr. Russoniello and Dr. McGhee designed the behavioral intervention, but it was delivered at the school by students of the university's recreational therapy program. Using college students had unexpected benefits, Dr. Russoniello said. “The children bonded with them instantly, perhaps because they were closer in age or because they could see the possibility of their own future success in them.”

The college students also gained valuable professional experience and proved their worth as an asset in times of emergency. “When we are responding to large-scale disasters, there aren't enough professionals to go around,” he said. “This study showed us that trained college students might be able to fill some of these gaps.”

SAN FRANCISCO — The first state effort to address childhood obesity through changes in public schools has met with some success, according to researchers who spoke at the annual meeting of the Society of Behavioral Medicine.

Arkansas Act 1220 passed into law in 2003, said James Raczynski, Ph.D. The product of a “remarkable confluence of political, private, and institutional support,” the law requires schools to monitor every student's weight annually, remove vending machines from elementary schools, and disclose all vending contracts. It also mandates the creation of state and local advisory committees to examine nutrition and physical activity programs in schools and to advise legislators on future childhood health policies.

Concerns about the number of obese and overweight children in Arkansas spurred legislators, physicians, and communities to work together on the law, said Dr. Raczynski of the University of Arkansas, Little Rock: 36% of children in the state are either overweight or at risk for being overweight.

Initially, public support for every aspect of the legislation was very high. Concerns arose during the first year, however. “The biggest issue was parental worry about the annual body mass index [BMI] measurement,” he said. “Parents feared that having their child identified as overweight or at risk would stigmatize the child.”

The law requires schools to send home letters about the annual BMI measurement; parents whose children were identified as overweight or at risk are advised to take the letter and the child to a physician. “We heard from some physicians that they were concerned they'd be overwhelmed with visits from worried parents,” Dr. Raczynski said.

He and his colleagues presented information from a 1-year evaluation of the law, which included interviews with parents, children, and physicians and visits to schools. Baseline data from spring 2004—when the law went into effect—were compared with data collected during 2005.

The annual BMI measurements appear to be having a positive impact on parents, said Delia West, Ph.D. After the school BMI screening, parents were significantly better at accurately identifying whether their child was overweight, said Dr. West of the University of Arkansas.

The baseline survey asked parents of children in kindergarten through grade 10 to assess their child's weight status. The follow-up survey asked the same after the child had brought an annual BMI report from school. Before the BMI screen, only 40% of parents accurately identified their child as overweight or at risk of becoming overweight. After the screen, that number increased to 50%.

Black parents and parents of children younger than 12 years were most likely to improve. Before the screen, only 35% of parents with young overweight children correctly identified their weight status. After the screen, that number rose to 65%. Black parents also improved their identification of overweight children, increasing from 30% correct before the BMI screen to 44% correct after the screen.

The change is important because family identification of weight problems can be the foundation of behavior change, Dr. West said. The parental concern of an increase in stigmatization of overweight children was not an issue, said Nadia Siddiqui of the University of Arkansas. Data from the baseline and 1-year follow-up surveys found no increase in weight-based teasing among any age group after the annual BMI measurement was instituted.

Physicians' concerns about being overwhelmed with unnecessarily worried parents were unfounded as well, said Jada Walker, also of the university. More than half of the 481 physicians surveyed (57%) reported that at least one family had brought in a BMI report to discuss. However, added Dr. Raczynski, it is somewhat worrisome that only 57% of physicians had dealt with a BMI concern prompted by the act.

SAN FRANCISCO — The first state effort to address childhood obesity through changes in public schools has met with some success, according to researchers who spoke at the annual meeting of the Society of Behavioral Medicine.

Arkansas Act 1220 passed into law in 2003, said James Raczynski, Ph.D. The product of a “remarkable confluence of political, private, and institutional support,” the law requires schools to monitor every student's weight annually, remove vending machines from elementary schools, and disclose all vending contracts. It also mandates the creation of state and local advisory committees to examine nutrition and physical activity programs in schools and to advise legislators on future childhood health policies.

Concerns about the number of obese and overweight children in Arkansas spurred legislators, physicians, and communities to work together on the law, said Dr. Raczynski of the University of Arkansas, Little Rock: 36% of children in the state are either overweight or at risk for being overweight.

Initially, public support for every aspect of the legislation was very high. Concerns arose during the first year, however. “The biggest issue was parental worry about the annual body mass index [BMI] measurement,” he said. “Parents feared that having their child identified as overweight or at risk would stigmatize the child.”

The law requires schools to send home letters about the annual BMI measurement; parents whose children were identified as overweight or at risk are advised to take the letter and the child to a physician. “We heard from some physicians that they were concerned they'd be overwhelmed with visits from worried parents,” Dr. Raczynski said.

He and his colleagues presented information from a 1-year evaluation of the law, which included interviews with parents, children, and physicians and visits to schools. Baseline data from spring 2004—when the law went into effect—were compared with data collected during 2005.

The annual BMI measurements appear to be having a positive impact on parents, said Delia West, Ph.D. After the school BMI screening, parents were significantly better at accurately identifying whether their child was overweight, said Dr. West of the University of Arkansas.

The baseline survey asked parents of children in kindergarten through grade 10 to assess their child's weight status. The follow-up survey asked the same after the child had brought an annual BMI report from school. Before the BMI screen, only 40% of parents accurately identified their child as overweight or at risk of becoming overweight. After the screen, that number increased to 50%.

Black parents and parents of children younger than 12 years were most likely to improve. Before the screen, only 35% of parents with young overweight children correctly identified their weight status. After the screen, that number rose to 65%. Black parents also improved their identification of overweight children, increasing from 30% correct before the BMI screen to 44% correct after the screen.

The change is important because family identification of weight problems can be the foundation of behavior change, Dr. West said. The parental concern of an increase in stigmatization of overweight children was not an issue, said Nadia Siddiqui of the University of Arkansas. Data from the baseline and 1-year follow-up surveys found no increase in weight-based teasing among any age group after the annual BMI measurement was instituted.

Physicians' concerns about being overwhelmed with unnecessarily worried parents were unfounded as well, said Jada Walker, also of the university. More than half of the 481 physicians surveyed (57%) reported that at least one family had brought in a BMI report to discuss. However, added Dr. Raczynski, it is somewhat worrisome that only 57% of physicians had dealt with a BMI concern prompted by the act.

SAN FRANCISCO — The first state effort to address childhood obesity through changes in public schools has met with some success, according to researchers who spoke at the annual meeting of the Society of Behavioral Medicine.

Arkansas Act 1220 passed into law in 2003, said James Raczynski, Ph.D. The product of a “remarkable confluence of political, private, and institutional support,” the law requires schools to monitor every student's weight annually, remove vending machines from elementary schools, and disclose all vending contracts. It also mandates the creation of state and local advisory committees to examine nutrition and physical activity programs in schools and to advise legislators on future childhood health policies.

Concerns about the number of obese and overweight children in Arkansas spurred legislators, physicians, and communities to work together on the law, said Dr. Raczynski of the University of Arkansas, Little Rock: 36% of children in the state are either overweight or at risk for being overweight.

Initially, public support for every aspect of the legislation was very high. Concerns arose during the first year, however. “The biggest issue was parental worry about the annual body mass index [BMI] measurement,” he said. “Parents feared that having their child identified as overweight or at risk would stigmatize the child.”

The law requires schools to send home letters about the annual BMI measurement; parents whose children were identified as overweight or at risk are advised to take the letter and the child to a physician. “We heard from some physicians that they were concerned they'd be overwhelmed with visits from worried parents,” Dr. Raczynski said.

He and his colleagues presented information from a 1-year evaluation of the law, which included interviews with parents, children, and physicians and visits to schools. Baseline data from spring 2004—when the law went into effect—were compared with data collected during 2005.

The annual BMI measurements appear to be having a positive impact on parents, said Delia West, Ph.D. After the school BMI screening, parents were significantly better at accurately identifying whether their child was overweight, said Dr. West of the University of Arkansas.

The baseline survey asked parents of children in kindergarten through grade 10 to assess their child's weight status. The follow-up survey asked the same after the child had brought an annual BMI report from school. Before the BMI screen, only 40% of parents accurately identified their child as overweight or at risk of becoming overweight. After the screen, that number increased to 50%.

Black parents and parents of children younger than 12 years were most likely to improve. Before the screen, only 35% of parents with young overweight children correctly identified their weight status. After the screen, that number rose to 65%. Black parents also improved their identification of overweight children, increasing from 30% correct before the BMI screen to 44% correct after the screen.

The change is important because family identification of weight problems can be the foundation of behavior change, Dr. West said. The parental concern of an increase in stigmatization of overweight children was not an issue, said Nadia Siddiqui of the University of Arkansas. Data from the baseline and 1-year follow-up surveys found no increase in weight-based teasing among any age group after the annual BMI measurement was instituted.

Physicians' concerns about being overwhelmed with unnecessarily worried parents were unfounded as well, said Jada Walker, also of the university. More than half of the 481 physicians surveyed (57%) reported that at least one family had brought in a BMI report to discuss. However, added Dr. Raczynski, it is somewhat worrisome that only 57% of physicians had dealt with a BMI concern prompted by the act.

Education level is inversely related to coronary artery calcium level, Lijing L. Yan, Ph.D., and colleagues have reported.

Subjects with less than a high school degree were four times more likely to have the marker than were those with more than a college degree. Preexisting cardiovascular risk factors were partly responsible, but even after adjusting for them, the risk differential remained highly significant, said Dr. Yan of Northwestern University, Chicago, and coauthors (JAMA 2006;295:1793–800).

The reason for the difference in coronary artery calcium (CAC) is something of a mystery, the researchers noted. Education-related health care discrepancies usually occur because of differences in income, socioeconomic status, access to care, adherence to therapy, and ability to navigate the health care system. “However, the association between education and CAC observed in our study was not affected by these factors related to access or treatment, because CAC is not symptomatic and the study was conducted among a relatively healthy cohort of early middle-aged adults without concurrent overt diseases,” Dr. Yan and colleagues wrote.

The investigators extracted data from the large prospective observational study, Coronary Artery Risk Development in Young Adults (CARDIA). The study examined risk factors in 3,672 urban adults (45% black and 54% female). Data were collected at baseline (ages 18–30 years) and 15 years later (ages 33–45 years). CAC scores were assessed by CT at the 15-year follow-up in 3,043 of the participants.

Comparing the 15-year data to baseline, the investigators found that significant increases in blood pressure, waist circumference, body mass index, smoking, and percentage taking antihypertensive medication were inversely associated with education.

After adjusting for age, gender, and race, those with less than a high school degree were four times more likely to have CAC than were those with more than a college degree.

The risk also was significantly elevated in high school graduates (odds ratio 1.9), those with some college (1.5), and college graduates (1.2).

The differential decreased after adjusting for cardiovascular risk factors (baseline systolic blood pressure, smoking, waist circumference, physical activity and total cholesterol levels), but was still significant for those with less than a high school degree (odds ratio 2.6).

“Fundamental changes in preventive measures very early in life are required to address social and economic disparities in health,” the authors said. “In addition, integrated prevention and intervention strategies effective for less educated persons are needed.”

Education level is inversely related to coronary artery calcium level, Lijing L. Yan, Ph.D., and colleagues have reported.

Subjects with less than a high school degree were four times more likely to have the marker than were those with more than a college degree. Preexisting cardiovascular risk factors were partly responsible, but even after adjusting for them, the risk differential remained highly significant, said Dr. Yan of Northwestern University, Chicago, and coauthors (JAMA 2006;295:1793–800).

The reason for the difference in coronary artery calcium (CAC) is something of a mystery, the researchers noted. Education-related health care discrepancies usually occur because of differences in income, socioeconomic status, access to care, adherence to therapy, and ability to navigate the health care system. “However, the association between education and CAC observed in our study was not affected by these factors related to access or treatment, because CAC is not symptomatic and the study was conducted among a relatively healthy cohort of early middle-aged adults without concurrent overt diseases,” Dr. Yan and colleagues wrote.

The investigators extracted data from the large prospective observational study, Coronary Artery Risk Development in Young Adults (CARDIA). The study examined risk factors in 3,672 urban adults (45% black and 54% female). Data were collected at baseline (ages 18–30 years) and 15 years later (ages 33–45 years). CAC scores were assessed by CT at the 15-year follow-up in 3,043 of the participants.

Comparing the 15-year data to baseline, the investigators found that significant increases in blood pressure, waist circumference, body mass index, smoking, and percentage taking antihypertensive medication were inversely associated with education.

After adjusting for age, gender, and race, those with less than a high school degree were four times more likely to have CAC than were those with more than a college degree.

The risk also was significantly elevated in high school graduates (odds ratio 1.9), those with some college (1.5), and college graduates (1.2).

The differential decreased after adjusting for cardiovascular risk factors (baseline systolic blood pressure, smoking, waist circumference, physical activity and total cholesterol levels), but was still significant for those with less than a high school degree (odds ratio 2.6).

“Fundamental changes in preventive measures very early in life are required to address social and economic disparities in health,” the authors said. “In addition, integrated prevention and intervention strategies effective for less educated persons are needed.”

Education level is inversely related to coronary artery calcium level, Lijing L. Yan, Ph.D., and colleagues have reported.

Subjects with less than a high school degree were four times more likely to have the marker than were those with more than a college degree. Preexisting cardiovascular risk factors were partly responsible, but even after adjusting for them, the risk differential remained highly significant, said Dr. Yan of Northwestern University, Chicago, and coauthors (JAMA 2006;295:1793–800).

The reason for the difference in coronary artery calcium (CAC) is something of a mystery, the researchers noted. Education-related health care discrepancies usually occur because of differences in income, socioeconomic status, access to care, adherence to therapy, and ability to navigate the health care system. “However, the association between education and CAC observed in our study was not affected by these factors related to access or treatment, because CAC is not symptomatic and the study was conducted among a relatively healthy cohort of early middle-aged adults without concurrent overt diseases,” Dr. Yan and colleagues wrote.

The investigators extracted data from the large prospective observational study, Coronary Artery Risk Development in Young Adults (CARDIA). The study examined risk factors in 3,672 urban adults (45% black and 54% female). Data were collected at baseline (ages 18–30 years) and 15 years later (ages 33–45 years). CAC scores were assessed by CT at the 15-year follow-up in 3,043 of the participants.

Comparing the 15-year data to baseline, the investigators found that significant increases in blood pressure, waist circumference, body mass index, smoking, and percentage taking antihypertensive medication were inversely associated with education.

After adjusting for age, gender, and race, those with less than a high school degree were four times more likely to have CAC than were those with more than a college degree.

The risk also was significantly elevated in high school graduates (odds ratio 1.9), those with some college (1.5), and college graduates (1.2).

The differential decreased after adjusting for cardiovascular risk factors (baseline systolic blood pressure, smoking, waist circumference, physical activity and total cholesterol levels), but was still significant for those with less than a high school degree (odds ratio 2.6).

“Fundamental changes in preventive measures very early in life are required to address social and economic disparities in health,” the authors said. “In addition, integrated prevention and intervention strategies effective for less educated persons are needed.”

WASHINGTON — There is no evidence that lamotrigine monotherapy increases the risk of major congenital malformations in infants exposed prenatally to the drug, according to updated data from the International Lamotrigine Pregnancy Registry.

However, when the drug was used as adjunctive therapy along with valproate, the rate of major congenital malformations was significantly higher than the rate for the background population, reported Dr. John A. Messenheimer of GlaxoSmithKline, Research Triangle Park, N.C.

Since its inception in 1992, the lamotrigine registry has recorded 2,000 pregnancies exposed to the drug in the first trimester. The interim report on data up to September 2005 was presented as a poster at the joint annual meeting of the American Epilepsy Society and the American Clinical Neurophysiology Society.

Most of the women (707) were taking lamotrigine as monotherapy, 256 were on polytherapy with lamotrigine but without valproate, and 119 were on polytherapy with lamotrigine and valproate.

Of the 20 major congenital malformations reported, two were club feet, two were cases of anencephaly, and three were ventricular septal defects. The remaining malformations included midline defects, urogenital defects, cortical dysplasia, hypoplastic left heart syndrome, hypoplasia of the left ventricle, and diaphragmatic hernia with abdominal organ displacement.

The malformation rate in women on lamotrigine monotherapy was 2.8%; the rate in those on polytherapy without valproate was 2.7%. The rate in women on polytherapy with valproate was 11.8%—significantly higher than the background population rate of 2%–3%.

There was no significant relationship between lamotrigine dosage and the incidence of malformation, Dr. Messenheimer said. The rate of malformations in women taking more than 400 mg/day was slightly elevated at 4%. But only 100 women were taking such a high dose, and the confidence intervals were wide

Published reports have identified a significantly increased risk of major congenital malformations among women taking valproate as monotherapy (10.7%). These studies prompted the American Epilepsy Society's pregnancy outcomes forum panel to recommend last year that valproate be avoided as a first-line therapy for any indication in women of childbearing age.

The lamotrigine registry could not determine whether valproate exposure alone could explain the higher rate of defects in the lamotrigine/valproate group. The numbers of antiepileptic drugs used may be inextricably tied to the frequency and severity of seizures, making it difficult to assess the contribution of each factor, he said.

In adults, lamotrigine is approved as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome and for conversion to monotherapy in adults with partial seizures who are receiving treatment. It is also approved for maintenance treatment of bipolar disorder, and it is a pregnancy category C drug.

Physicians are asked to report exposed pregnancies to the international registry by calling 800–336–2176 as soon as the pregnancy is identified. The complete interim report of the registry is available by calling the same number.

WASHINGTON — There is no evidence that lamotrigine monotherapy increases the risk of major congenital malformations in infants exposed prenatally to the drug, according to updated data from the International Lamotrigine Pregnancy Registry.

However, when the drug was used as adjunctive therapy along with valproate, the rate of major congenital malformations was significantly higher than the rate for the background population, reported Dr. John A. Messenheimer of GlaxoSmithKline, Research Triangle Park, N.C.

Since its inception in 1992, the lamotrigine registry has recorded 2,000 pregnancies exposed to the drug in the first trimester. The interim report on data up to September 2005 was presented as a poster at the joint annual meeting of the American Epilepsy Society and the American Clinical Neurophysiology Society.

Most of the women (707) were taking lamotrigine as monotherapy, 256 were on polytherapy with lamotrigine but without valproate, and 119 were on polytherapy with lamotrigine and valproate.

Of the 20 major congenital malformations reported, two were club feet, two were cases of anencephaly, and three were ventricular septal defects. The remaining malformations included midline defects, urogenital defects, cortical dysplasia, hypoplastic left heart syndrome, hypoplasia of the left ventricle, and diaphragmatic hernia with abdominal organ displacement.

The malformation rate in women on lamotrigine monotherapy was 2.8%; the rate in those on polytherapy without valproate was 2.7%. The rate in women on polytherapy with valproate was 11.8%—significantly higher than the background population rate of 2%–3%.

There was no significant relationship between lamotrigine dosage and the incidence of malformation, Dr. Messenheimer said. The rate of malformations in women taking more than 400 mg/day was slightly elevated at 4%. But only 100 women were taking such a high dose, and the confidence intervals were wide

Published reports have identified a significantly increased risk of major congenital malformations among women taking valproate as monotherapy (10.7%). These studies prompted the American Epilepsy Society's pregnancy outcomes forum panel to recommend last year that valproate be avoided as a first-line therapy for any indication in women of childbearing age.

The lamotrigine registry could not determine whether valproate exposure alone could explain the higher rate of defects in the lamotrigine/valproate group. The numbers of antiepileptic drugs used may be inextricably tied to the frequency and severity of seizures, making it difficult to assess the contribution of each factor, he said.

In adults, lamotrigine is approved as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome and for conversion to monotherapy in adults with partial seizures who are receiving treatment. It is also approved for maintenance treatment of bipolar disorder, and it is a pregnancy category C drug.

Physicians are asked to report exposed pregnancies to the international registry by calling 800–336–2176 as soon as the pregnancy is identified. The complete interim report of the registry is available by calling the same number.

WASHINGTON — There is no evidence that lamotrigine monotherapy increases the risk of major congenital malformations in infants exposed prenatally to the drug, according to updated data from the International Lamotrigine Pregnancy Registry.

However, when the drug was used as adjunctive therapy along with valproate, the rate of major congenital malformations was significantly higher than the rate for the background population, reported Dr. John A. Messenheimer of GlaxoSmithKline, Research Triangle Park, N.C.

Since its inception in 1992, the lamotrigine registry has recorded 2,000 pregnancies exposed to the drug in the first trimester. The interim report on data up to September 2005 was presented as a poster at the joint annual meeting of the American Epilepsy Society and the American Clinical Neurophysiology Society.

Most of the women (707) were taking lamotrigine as monotherapy, 256 were on polytherapy with lamotrigine but without valproate, and 119 were on polytherapy with lamotrigine and valproate.

Of the 20 major congenital malformations reported, two were club feet, two were cases of anencephaly, and three were ventricular septal defects. The remaining malformations included midline defects, urogenital defects, cortical dysplasia, hypoplastic left heart syndrome, hypoplasia of the left ventricle, and diaphragmatic hernia with abdominal organ displacement.

The malformation rate in women on lamotrigine monotherapy was 2.8%; the rate in those on polytherapy without valproate was 2.7%. The rate in women on polytherapy with valproate was 11.8%—significantly higher than the background population rate of 2%–3%.

There was no significant relationship between lamotrigine dosage and the incidence of malformation, Dr. Messenheimer said. The rate of malformations in women taking more than 400 mg/day was slightly elevated at 4%. But only 100 women were taking such a high dose, and the confidence intervals were wide

Published reports have identified a significantly increased risk of major congenital malformations among women taking valproate as monotherapy (10.7%). These studies prompted the American Epilepsy Society's pregnancy outcomes forum panel to recommend last year that valproate be avoided as a first-line therapy for any indication in women of childbearing age.

The lamotrigine registry could not determine whether valproate exposure alone could explain the higher rate of defects in the lamotrigine/valproate group. The numbers of antiepileptic drugs used may be inextricably tied to the frequency and severity of seizures, making it difficult to assess the contribution of each factor, he said.

In adults, lamotrigine is approved as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome and for conversion to monotherapy in adults with partial seizures who are receiving treatment. It is also approved for maintenance treatment of bipolar disorder, and it is a pregnancy category C drug.

Physicians are asked to report exposed pregnancies to the international registry by calling 800–336–2176 as soon as the pregnancy is identified. The complete interim report of the registry is available by calling the same number.

The rate of invasive pneumococcal disease among U.S. infants younger than 2 months has declined by 43% since the introduction of the pneumococcal conjugate vaccine in the United States, even though these children are too young to have received the vaccine.

“These data are the first to suggest that neonates and infants too young to receive PCV7 are benefiting from herd immunity,” said Dr. Katherine A. Poehling and her coinvestigators. “Although the exact mechanism of herd immunity is uncertain, one hypothesis is that vaccinated children are less likely to have nasal carriage of pneumococcus and hence have less pneumococcal transmission to their contacts.”

The biggest decrease occurred in black infants, among whom the rate of invasive disease declined 71% from 1997 to 2004. The change was enough to eliminate the racial disparity in invasive pneumococcal disease between black and white infants, the authors said (JAMA 2006;295:1668–74).

Their population-based study examined rates of confirmed invasive pneumococcal disease in eight states among infants younger than 3 months, from 1997 to 2004.

During that time, there were 170 cases: 89 occurred in the 3 years before the vaccine (PCV7) was introduced, 24 cases during the transition year (2000–2001), and 57 in the 3 years after the vaccine was introduced.

Among all infants younger than 3 months—some of whom would have received at least one dose of the vaccine—the mean rate of disease decreased 42%, from 12 per 100,000 to 7 per 100,000. The rate among infants younger than 2 months—those too young to receive any doses of the vaccine—declined 43%, from 7 per 100,000 to 4 per 100,000.

The largest change occurred among black infants, noted Dr. Poehling, of Vanderbilt University, Nashville, Tenn., and her colleagues.

In this group, the rate of invasive pneumococcal disease decreased 71%, from 17 per 100,000 to 5 per 100,000.

The precipitous drop in disease echoes that which occurred after the introduction of effective vaccines for other communicable diseases, said Dr. Matthew L. Boulton, professor of epidemiology and director of the preventive medicine residency program at the University of Michigan, Ann Arbor. The challenge now will be to continue reinforcing the importance of vaccination to parents who might hear conflicting messages.

“Paradoxically, the more successful we are in a public health intervention like this, the less people become willing to have their children vaccinated,” he said in an interview. This has to do both with misinformation about immunization side effects and complacency about the decrease in disease risk. “It's critical to keep a positive message about the importance of immunization out in the public.”

Remind parents of how seriously communicable diseases once affected children's health, and point out the risks of immunization complications in real terms. “Tell them how many millions of doses are given and how very, very few children have true complications,” he said. “It's a very tiny number.”

The study also examined changes in the pneumococcal serotypes causing the infections. Serotypes resistant to antibiotics decreased 75% from 1998 (the first year of serotyping) to 2004. Antibiotic-susceptible serotypes also decreased, but to a lesser extent (50%).

The study found small increases in disease caused by two serotypes present in the pneumococcal conjugate vaccine (18C and 19F) and in disease caused by a few nonvaccine strains that were not present prior to the introduction of PCV7.

These changes are troubling, according to Moe H. Kyaw, Ph.D., and his associates, whose epidemiologic study arrived at similar conclusions regarding serotype changes after PCV7: Rates of invasive disease caused by antibiotic-resistant bacteria have declined, but rates of resistant disease caused by 19A increased by 238% from 1999 to 2004. The study also found modest increases in invasive disease caused by resistant strains not included in the vaccine (N. Engl. J. Med. 2006;354:1455–63).

“The increase in resistant disease caused by serotype 19A is a concern,” said Dr. Kyaw, of the Centers for Disease Control and Prevention, and his colleagues. “It is difficult to predict whether the increase in resistant serotype 19A or other serotypes not covered by the vaccine will continue. Nevertheless, this replacement disease has the potential to reduce the overall benefit of the vaccine against resistant infections.”

Replacement disease with resistant strains, particularly 19A, is a surprise—and not a nice one, Dr. Daniel M. Musher said in an accompanying editorial. “This problem is compounded by the fact that, through genetic transformation, pneumococci can switch capsules.” If pneumococcal strains with pandemic potential, such as 6B, 9V, or 23F, acquire a resistant capsule, dangerous new types could emerge.

There is insufficient information to make any predictions about the endemic spread of these replacement serotypes, Dr. Boulton said. “We have seen only cases of disease being caused by these replacement strains, but that's all. It would be a very different situation if we begin to see levels of transmission comparable to what was seen in the serotypes included in the vaccine.”

The rate of invasive pneumococcal disease among U.S. infants younger than 2 months has declined by 43% since the introduction of the pneumococcal conjugate vaccine in the United States, even though these children are too young to have received the vaccine.

“These data are the first to suggest that neonates and infants too young to receive PCV7 are benefiting from herd immunity,” said Dr. Katherine A. Poehling and her coinvestigators. “Although the exact mechanism of herd immunity is uncertain, one hypothesis is that vaccinated children are less likely to have nasal carriage of pneumococcus and hence have less pneumococcal transmission to their contacts.”

The biggest decrease occurred in black infants, among whom the rate of invasive disease declined 71% from 1997 to 2004. The change was enough to eliminate the racial disparity in invasive pneumococcal disease between black and white infants, the authors said (JAMA 2006;295:1668–74).

Their population-based study examined rates of confirmed invasive pneumococcal disease in eight states among infants younger than 3 months, from 1997 to 2004.

During that time, there were 170 cases: 89 occurred in the 3 years before the vaccine (PCV7) was introduced, 24 cases during the transition year (2000–2001), and 57 in the 3 years after the vaccine was introduced.

Among all infants younger than 3 months—some of whom would have received at least one dose of the vaccine—the mean rate of disease decreased 42%, from 12 per 100,000 to 7 per 100,000. The rate among infants younger than 2 months—those too young to receive any doses of the vaccine—declined 43%, from 7 per 100,000 to 4 per 100,000.

The largest change occurred among black infants, noted Dr. Poehling, of Vanderbilt University, Nashville, Tenn., and her colleagues.

In this group, the rate of invasive pneumococcal disease decreased 71%, from 17 per 100,000 to 5 per 100,000.

The precipitous drop in disease echoes that which occurred after the introduction of effective vaccines for other communicable diseases, said Dr. Matthew L. Boulton, professor of epidemiology and director of the preventive medicine residency program at the University of Michigan, Ann Arbor. The challenge now will be to continue reinforcing the importance of vaccination to parents who might hear conflicting messages.

“Paradoxically, the more successful we are in a public health intervention like this, the less people become willing to have their children vaccinated,” he said in an interview. This has to do both with misinformation about immunization side effects and complacency about the decrease in disease risk. “It's critical to keep a positive message about the importance of immunization out in the public.”

Remind parents of how seriously communicable diseases once affected children's health, and point out the risks of immunization complications in real terms. “Tell them how many millions of doses are given and how very, very few children have true complications,” he said. “It's a very tiny number.”

The study also examined changes in the pneumococcal serotypes causing the infections. Serotypes resistant to antibiotics decreased 75% from 1998 (the first year of serotyping) to 2004. Antibiotic-susceptible serotypes also decreased, but to a lesser extent (50%).

The study found small increases in disease caused by two serotypes present in the pneumococcal conjugate vaccine (18C and 19F) and in disease caused by a few nonvaccine strains that were not present prior to the introduction of PCV7.

These changes are troubling, according to Moe H. Kyaw, Ph.D., and his associates, whose epidemiologic study arrived at similar conclusions regarding serotype changes after PCV7: Rates of invasive disease caused by antibiotic-resistant bacteria have declined, but rates of resistant disease caused by 19A increased by 238% from 1999 to 2004. The study also found modest increases in invasive disease caused by resistant strains not included in the vaccine (N. Engl. J. Med. 2006;354:1455–63).

“The increase in resistant disease caused by serotype 19A is a concern,” said Dr. Kyaw, of the Centers for Disease Control and Prevention, and his colleagues. “It is difficult to predict whether the increase in resistant serotype 19A or other serotypes not covered by the vaccine will continue. Nevertheless, this replacement disease has the potential to reduce the overall benefit of the vaccine against resistant infections.”

Replacement disease with resistant strains, particularly 19A, is a surprise—and not a nice one, Dr. Daniel M. Musher said in an accompanying editorial. “This problem is compounded by the fact that, through genetic transformation, pneumococci can switch capsules.” If pneumococcal strains with pandemic potential, such as 6B, 9V, or 23F, acquire a resistant capsule, dangerous new types could emerge.

There is insufficient information to make any predictions about the endemic spread of these replacement serotypes, Dr. Boulton said. “We have seen only cases of disease being caused by these replacement strains, but that's all. It would be a very different situation if we begin to see levels of transmission comparable to what was seen in the serotypes included in the vaccine.”

The rate of invasive pneumococcal disease among U.S. infants younger than 2 months has declined by 43% since the introduction of the pneumococcal conjugate vaccine in the United States, even though these children are too young to have received the vaccine.

“These data are the first to suggest that neonates and infants too young to receive PCV7 are benefiting from herd immunity,” said Dr. Katherine A. Poehling and her coinvestigators. “Although the exact mechanism of herd immunity is uncertain, one hypothesis is that vaccinated children are less likely to have nasal carriage of pneumococcus and hence have less pneumococcal transmission to their contacts.”

The biggest decrease occurred in black infants, among whom the rate of invasive disease declined 71% from 1997 to 2004. The change was enough to eliminate the racial disparity in invasive pneumococcal disease between black and white infants, the authors said (JAMA 2006;295:1668–74).

Their population-based study examined rates of confirmed invasive pneumococcal disease in eight states among infants younger than 3 months, from 1997 to 2004.

During that time, there were 170 cases: 89 occurred in the 3 years before the vaccine (PCV7) was introduced, 24 cases during the transition year (2000–2001), and 57 in the 3 years after the vaccine was introduced.

Among all infants younger than 3 months—some of whom would have received at least one dose of the vaccine—the mean rate of disease decreased 42%, from 12 per 100,000 to 7 per 100,000. The rate among infants younger than 2 months—those too young to receive any doses of the vaccine—declined 43%, from 7 per 100,000 to 4 per 100,000.

The largest change occurred among black infants, noted Dr. Poehling, of Vanderbilt University, Nashville, Tenn., and her colleagues.

In this group, the rate of invasive pneumococcal disease decreased 71%, from 17 per 100,000 to 5 per 100,000.

The precipitous drop in disease echoes that which occurred after the introduction of effective vaccines for other communicable diseases, said Dr. Matthew L. Boulton, professor of epidemiology and director of the preventive medicine residency program at the University of Michigan, Ann Arbor. The challenge now will be to continue reinforcing the importance of vaccination to parents who might hear conflicting messages.

“Paradoxically, the more successful we are in a public health intervention like this, the less people become willing to have their children vaccinated,” he said in an interview. This has to do both with misinformation about immunization side effects and complacency about the decrease in disease risk. “It's critical to keep a positive message about the importance of immunization out in the public.”

Remind parents of how seriously communicable diseases once affected children's health, and point out the risks of immunization complications in real terms. “Tell them how many millions of doses are given and how very, very few children have true complications,” he said. “It's a very tiny number.”

The study also examined changes in the pneumococcal serotypes causing the infections. Serotypes resistant to antibiotics decreased 75% from 1998 (the first year of serotyping) to 2004. Antibiotic-susceptible serotypes also decreased, but to a lesser extent (50%).

The study found small increases in disease caused by two serotypes present in the pneumococcal conjugate vaccine (18C and 19F) and in disease caused by a few nonvaccine strains that were not present prior to the introduction of PCV7.

These changes are troubling, according to Moe H. Kyaw, Ph.D., and his associates, whose epidemiologic study arrived at similar conclusions regarding serotype changes after PCV7: Rates of invasive disease caused by antibiotic-resistant bacteria have declined, but rates of resistant disease caused by 19A increased by 238% from 1999 to 2004. The study also found modest increases in invasive disease caused by resistant strains not included in the vaccine (N. Engl. J. Med. 2006;354:1455–63).

“The increase in resistant disease caused by serotype 19A is a concern,” said Dr. Kyaw, of the Centers for Disease Control and Prevention, and his colleagues. “It is difficult to predict whether the increase in resistant serotype 19A or other serotypes not covered by the vaccine will continue. Nevertheless, this replacement disease has the potential to reduce the overall benefit of the vaccine against resistant infections.”

Replacement disease with resistant strains, particularly 19A, is a surprise—and not a nice one, Dr. Daniel M. Musher said in an accompanying editorial. “This problem is compounded by the fact that, through genetic transformation, pneumococci can switch capsules.” If pneumococcal strains with pandemic potential, such as 6B, 9V, or 23F, acquire a resistant capsule, dangerous new types could emerge.

There is insufficient information to make any predictions about the endemic spread of these replacement serotypes, Dr. Boulton said. “We have seen only cases of disease being caused by these replacement strains, but that's all. It would be a very different situation if we begin to see levels of transmission comparable to what was seen in the serotypes included in the vaccine.”

SAN FRANCISCO — Hospitalization may provide a unique opportunity to offer counseling to patients with alcohol problems.

“As a result of an acute medical event, many patients have a high motivation to change their drinking behavior,” Jennis Freyer, Ph.D., said in an interview. “Hospitalization offers the chance to reach patients with alcohol-attributable disease proactively.”

In a poster presented at the annual meeting of the Society of Behavioral Medicine, Dr. Freyer assessed openness to alcohol counseling in patients who stayed more than 24 hours in one of four German hospitals. Screening with the Munich-Composite International Diagnostic Interview identified 1,150 patients with alcohol problems. She assessed the severity of the alcohol problem with the Alcohol Use Disorders Identification Test and mental health with the Rand Mental Health Index.

Most of the patients (93%) were male; the mean age was 42 years. Dependence was the most frequently identified alcohol problem (49%), followed by alcohol abuse (12%), at-risk drinking (30%), and episodic heavy drinking (9%). The mean Alcohol Use Disorders Identification Test score was 19; the mean Mental Health Index score was 7.

She assessed the patients' openness for counseling by using a simple two-item true-false survey (“I'm open to learn more about help” and “I want to find out how to help myself”). Patients then completed the Readiness to Change Questionnaire and the Treatment Readiness Tool. Overall, 66% of the patients were open to the idea of alcohol counseling. More of those with alcohol dependence were open to counseling than those with alcohol abuse or at-risk drinking (77% vs. 56%).

“Those with alcohol dependence are more likely to have developed problem recognition,” said Dr. Freyer of the University of Greifswald, Germany. “Having identified alcohol as being part of their problem may increase their openness for counseling, especially when they feel helpless about their situation.”

However, she noted, more than half of risky drinkers and those with alcohol dependence were still open to the idea of getting counseling.

In the Readiness to Change scale, those in the contemplation stage were twice as likely to be open to counseling as were those in the precontemplation stage. In the Treatment Readiness assessment, those in the contemplation stage were nine times more likely to accept counseling than were those in the precontemplation stage.

SAN FRANCISCO — Hospitalization may provide a unique opportunity to offer counseling to patients with alcohol problems.

“As a result of an acute medical event, many patients have a high motivation to change their drinking behavior,” Jennis Freyer, Ph.D., said in an interview. “Hospitalization offers the chance to reach patients with alcohol-attributable disease proactively.”

In a poster presented at the annual meeting of the Society of Behavioral Medicine, Dr. Freyer assessed openness to alcohol counseling in patients who stayed more than 24 hours in one of four German hospitals. Screening with the Munich-Composite International Diagnostic Interview identified 1,150 patients with alcohol problems. She assessed the severity of the alcohol problem with the Alcohol Use Disorders Identification Test and mental health with the Rand Mental Health Index.

Most of the patients (93%) were male; the mean age was 42 years. Dependence was the most frequently identified alcohol problem (49%), followed by alcohol abuse (12%), at-risk drinking (30%), and episodic heavy drinking (9%). The mean Alcohol Use Disorders Identification Test score was 19; the mean Mental Health Index score was 7.

She assessed the patients' openness for counseling by using a simple two-item true-false survey (“I'm open to learn more about help” and “I want to find out how to help myself”). Patients then completed the Readiness to Change Questionnaire and the Treatment Readiness Tool. Overall, 66% of the patients were open to the idea of alcohol counseling. More of those with alcohol dependence were open to counseling than those with alcohol abuse or at-risk drinking (77% vs. 56%).

“Those with alcohol dependence are more likely to have developed problem recognition,” said Dr. Freyer of the University of Greifswald, Germany. “Having identified alcohol as being part of their problem may increase their openness for counseling, especially when they feel helpless about their situation.”

However, she noted, more than half of risky drinkers and those with alcohol dependence were still open to the idea of getting counseling.

In the Readiness to Change scale, those in the contemplation stage were twice as likely to be open to counseling as were those in the precontemplation stage. In the Treatment Readiness assessment, those in the contemplation stage were nine times more likely to accept counseling than were those in the precontemplation stage.

SAN FRANCISCO — Hospitalization may provide a unique opportunity to offer counseling to patients with alcohol problems.

“As a result of an acute medical event, many patients have a high motivation to change their drinking behavior,” Jennis Freyer, Ph.D., said in an interview. “Hospitalization offers the chance to reach patients with alcohol-attributable disease proactively.”

In a poster presented at the annual meeting of the Society of Behavioral Medicine, Dr. Freyer assessed openness to alcohol counseling in patients who stayed more than 24 hours in one of four German hospitals. Screening with the Munich-Composite International Diagnostic Interview identified 1,150 patients with alcohol problems. She assessed the severity of the alcohol problem with the Alcohol Use Disorders Identification Test and mental health with the Rand Mental Health Index.

Most of the patients (93%) were male; the mean age was 42 years. Dependence was the most frequently identified alcohol problem (49%), followed by alcohol abuse (12%), at-risk drinking (30%), and episodic heavy drinking (9%). The mean Alcohol Use Disorders Identification Test score was 19; the mean Mental Health Index score was 7.

She assessed the patients' openness for counseling by using a simple two-item true-false survey (“I'm open to learn more about help” and “I want to find out how to help myself”). Patients then completed the Readiness to Change Questionnaire and the Treatment Readiness Tool. Overall, 66% of the patients were open to the idea of alcohol counseling. More of those with alcohol dependence were open to counseling than those with alcohol abuse or at-risk drinking (77% vs. 56%).

“Those with alcohol dependence are more likely to have developed problem recognition,” said Dr. Freyer of the University of Greifswald, Germany. “Having identified alcohol as being part of their problem may increase their openness for counseling, especially when they feel helpless about their situation.”

However, she noted, more than half of risky drinkers and those with alcohol dependence were still open to the idea of getting counseling.

In the Readiness to Change scale, those in the contemplation stage were twice as likely to be open to counseling as were those in the precontemplation stage. In the Treatment Readiness assessment, those in the contemplation stage were nine times more likely to accept counseling than were those in the precontemplation stage.