Michele G. Sullivan

Parents of adolescents appear to accept the idea of vaccinating their teens against sexually transmitted infections, expressing the most concern about the efficacy of the vaccine and the severity of the infection it could prevent, rather than the mode of transmission, Gregory D. Zimet, Ph.D., and his colleagues have reported.

Some surveys have suggested that physicians and others who provide care to adolescents might be reluctant to recommend STI vaccines, perhaps because of concerns about how parents might react. “The high acceptability ratings reported by most parents in this study suggest that most parents would not react negatively to the suggestion,” said Dr. Zimet of Indiana University, Indianapolis (Arch. Pediatr. Adolesc. Med. 2005;159:132-7).

The researchers surveyed 278 parents of adolescents aged 12-17 years. The mean age of parents was 41 years. The mean age of children was 14 years, and 69% were female.

The survey presented nine different vaccine scenarios, each of which uniquely defined four variables: mode of transmission (STI or non-STI), severity of infection (curable, chronic and incurable, usually fatal); vaccine efficacy (50%, 70%, or 90%); and availability of behavioral methods of prevention (such as condoms or hand washing).

For each scenario, parents were asked, “If this vaccine were available today and you had the time, would you let your child get vaccinated?” Parents rated vaccine acceptability on a scale of 0-100, with 100 being “I would definitely let my child get this vaccine.”

The parents were recruited from urban, Midwestern adolescent medicine clinics and private practices. More than half (56%) were white, and about 40% were African American. Less than 2% were Hispanic.

The least acceptable scenario, with a mean score of about 75, was a vaccine with 50% efficacy against a non-STI that could be prevented by hand washing. The most acceptable scenario, with a mean score of 88.6, was a vaccine with 90% efficacy that protected against a usually fatal non-STI that could not be prevented by hand washing.

The mean score for the six STI scenarios was slightly, but not significantly, higher than the mean score for the three non-STI scenarios. The lowest-scoring STI vaccine scenario was a vaccine that was 50% effective against a curable STI that could not be prevented with condoms (75.7). The highest-scoring STI scenario was a vaccine that was 70% effective in preventing a usually fatal STI that could be prevented by the use of condoms (84.4).

For the majority of parents, sexual transmissibility had the least influence on acceptability ratings.

Vaccine efficacy was the most influential factor in the ratings, followed by severity of infection and availability of behavioral protection. However, 31 parents (11%) indicated a relatively strong preference for an STI vaccine, and 16 parents (6%) indicated a relatively strong opposition to it.

About a quarter (27%) of the parents gave ratings of 100 to every vaccine. High accepters were more likely to be in the urban clinics and to have only a high school diploma. Acceptability was not related to the child's age, suggesting that parents may not make these decisions based on the proximity of their child's sexual activity.

In an accompanying editorial, Susan L. Rosenthal, Ph.D., of the University of Texas, Galveston, said questions still remain, not only about STI vaccine acceptability, but how to maximize its use to offer the broadest protection.

The study involved mostly white, Midwestern parents, so the results cannot be extrapolated to other groups. And, she noted, it does not address provider feelings about the child's age—a factor that will invariably affect who gets vaccinated, and when. “It will be important to understand how the age of the child or adolescent will influence parents' and health care professionals' attitudes, including assessing the acceptability of vaccinating even younger children,” she said (Arch. Pediatr. Adolesc. Med. 2005:159;190-2).

Parents of adolescents appear to accept the idea of vaccinating their teens against sexually transmitted infections, expressing the most concern about the efficacy of the vaccine and the severity of the infection it could prevent, rather than the mode of transmission, Gregory D. Zimet, Ph.D., and his colleagues have reported.

Some surveys have suggested that physicians and others who provide care to adolescents might be reluctant to recommend STI vaccines, perhaps because of concerns about how parents might react. “The high acceptability ratings reported by most parents in this study suggest that most parents would not react negatively to the suggestion,” said Dr. Zimet of Indiana University, Indianapolis (Arch. Pediatr. Adolesc. Med. 2005;159:132-7).

The researchers surveyed 278 parents of adolescents aged 12-17 years. The mean age of parents was 41 years. The mean age of children was 14 years, and 69% were female.

The survey presented nine different vaccine scenarios, each of which uniquely defined four variables: mode of transmission (STI or non-STI), severity of infection (curable, chronic and incurable, usually fatal); vaccine efficacy (50%, 70%, or 90%); and availability of behavioral methods of prevention (such as condoms or hand washing).

For each scenario, parents were asked, “If this vaccine were available today and you had the time, would you let your child get vaccinated?” Parents rated vaccine acceptability on a scale of 0-100, with 100 being “I would definitely let my child get this vaccine.”

The parents were recruited from urban, Midwestern adolescent medicine clinics and private practices. More than half (56%) were white, and about 40% were African American. Less than 2% were Hispanic.

The least acceptable scenario, with a mean score of about 75, was a vaccine with 50% efficacy against a non-STI that could be prevented by hand washing. The most acceptable scenario, with a mean score of 88.6, was a vaccine with 90% efficacy that protected against a usually fatal non-STI that could not be prevented by hand washing.

The mean score for the six STI scenarios was slightly, but not significantly, higher than the mean score for the three non-STI scenarios. The lowest-scoring STI vaccine scenario was a vaccine that was 50% effective against a curable STI that could not be prevented with condoms (75.7). The highest-scoring STI scenario was a vaccine that was 70% effective in preventing a usually fatal STI that could be prevented by the use of condoms (84.4).

For the majority of parents, sexual transmissibility had the least influence on acceptability ratings.

Vaccine efficacy was the most influential factor in the ratings, followed by severity of infection and availability of behavioral protection. However, 31 parents (11%) indicated a relatively strong preference for an STI vaccine, and 16 parents (6%) indicated a relatively strong opposition to it.

About a quarter (27%) of the parents gave ratings of 100 to every vaccine. High accepters were more likely to be in the urban clinics and to have only a high school diploma. Acceptability was not related to the child's age, suggesting that parents may not make these decisions based on the proximity of their child's sexual activity.

In an accompanying editorial, Susan L. Rosenthal, Ph.D., of the University of Texas, Galveston, said questions still remain, not only about STI vaccine acceptability, but how to maximize its use to offer the broadest protection.

The study involved mostly white, Midwestern parents, so the results cannot be extrapolated to other groups. And, she noted, it does not address provider feelings about the child's age—a factor that will invariably affect who gets vaccinated, and when. “It will be important to understand how the age of the child or adolescent will influence parents' and health care professionals' attitudes, including assessing the acceptability of vaccinating even younger children,” she said (Arch. Pediatr. Adolesc. Med. 2005:159;190-2).

Parents of adolescents appear to accept the idea of vaccinating their teens against sexually transmitted infections, expressing the most concern about the efficacy of the vaccine and the severity of the infection it could prevent, rather than the mode of transmission, Gregory D. Zimet, Ph.D., and his colleagues have reported.

Some surveys have suggested that physicians and others who provide care to adolescents might be reluctant to recommend STI vaccines, perhaps because of concerns about how parents might react. “The high acceptability ratings reported by most parents in this study suggest that most parents would not react negatively to the suggestion,” said Dr. Zimet of Indiana University, Indianapolis (Arch. Pediatr. Adolesc. Med. 2005;159:132-7).

The researchers surveyed 278 parents of adolescents aged 12-17 years. The mean age of parents was 41 years. The mean age of children was 14 years, and 69% were female.

The survey presented nine different vaccine scenarios, each of which uniquely defined four variables: mode of transmission (STI or non-STI), severity of infection (curable, chronic and incurable, usually fatal); vaccine efficacy (50%, 70%, or 90%); and availability of behavioral methods of prevention (such as condoms or hand washing).

For each scenario, parents were asked, “If this vaccine were available today and you had the time, would you let your child get vaccinated?” Parents rated vaccine acceptability on a scale of 0-100, with 100 being “I would definitely let my child get this vaccine.”

The parents were recruited from urban, Midwestern adolescent medicine clinics and private practices. More than half (56%) were white, and about 40% were African American. Less than 2% were Hispanic.

The least acceptable scenario, with a mean score of about 75, was a vaccine with 50% efficacy against a non-STI that could be prevented by hand washing. The most acceptable scenario, with a mean score of 88.6, was a vaccine with 90% efficacy that protected against a usually fatal non-STI that could not be prevented by hand washing.

The mean score for the six STI scenarios was slightly, but not significantly, higher than the mean score for the three non-STI scenarios. The lowest-scoring STI vaccine scenario was a vaccine that was 50% effective against a curable STI that could not be prevented with condoms (75.7). The highest-scoring STI scenario was a vaccine that was 70% effective in preventing a usually fatal STI that could be prevented by the use of condoms (84.4).

For the majority of parents, sexual transmissibility had the least influence on acceptability ratings.

Vaccine efficacy was the most influential factor in the ratings, followed by severity of infection and availability of behavioral protection. However, 31 parents (11%) indicated a relatively strong preference for an STI vaccine, and 16 parents (6%) indicated a relatively strong opposition to it.

About a quarter (27%) of the parents gave ratings of 100 to every vaccine. High accepters were more likely to be in the urban clinics and to have only a high school diploma. Acceptability was not related to the child's age, suggesting that parents may not make these decisions based on the proximity of their child's sexual activity.

In an accompanying editorial, Susan L. Rosenthal, Ph.D., of the University of Texas, Galveston, said questions still remain, not only about STI vaccine acceptability, but how to maximize its use to offer the broadest protection.

The study involved mostly white, Midwestern parents, so the results cannot be extrapolated to other groups. And, she noted, it does not address provider feelings about the child's age—a factor that will invariably affect who gets vaccinated, and when. “It will be important to understand how the age of the child or adolescent will influence parents' and health care professionals' attitudes, including assessing the acceptability of vaccinating even younger children,” she said (Arch. Pediatr. Adolesc. Med. 2005:159;190-2).

Women who took tamoxifen for breast cancer had a 60% decreased risk of developing ischemic heart disease during 5 years of treatment, compared with women who had other cancers not treated with tamoxifen, Brian D. Bradbury, D.Sc., and his colleagues reported.

The large case-control study supports other recent studies showing that tamoxifen has a beneficial effect on low-density lipoprotein and total cholesterol levels in postmenopausal women taking the drug.

Dr. Bradbury of Boston University School of Public Health and his associates based their analysis on data derived from the United Kingdom's General Practice Research Database. Since 1987, more than 3 million U.K. residents have been enrolled in the database (Cancer 2005;103:1114-21).

The researchers matched 3,030 women aged 30-85 years with a first-time diagnosis of breast cancer treated with tamoxifen with 4,233 controls who had other cancers (bladder, colorectal, and nonmelanoma skin cancer). Women with a history of heart attack, angina pectoris, and HIV/acquired immunodeficiency syndrome were excluded. The median follow-up for all women was about 2 years. Of a total of 154 cases of ischemic heart disease, women with breast cancer had a reduced rate of heart disease, compared with women with the other cancers (hazard ratio=0.5).

The investigators then matched 585 of the controls to 151 of the women with heart disease. The women with heart disease were more likely to be obese, to be former smokers, and to have been treated for hypertension, compared with the controls. Current use of tamoxifen was associated with a 60% decreased risk of heart disease. When myocardial infarction and angina were assessed separately, the decreased risk for current tamoxifen users was 80% for MI and 60% for treated angina.

The protective effect lasted throughout the 5-year treatment period, with a 60% decreased risk for the first 4 years and a 50% decreased risk thereafter.

Women who took tamoxifen for breast cancer had a 60% decreased risk of developing ischemic heart disease during 5 years of treatment, compared with women who had other cancers not treated with tamoxifen, Brian D. Bradbury, D.Sc., and his colleagues reported.

The large case-control study supports other recent studies showing that tamoxifen has a beneficial effect on low-density lipoprotein and total cholesterol levels in postmenopausal women taking the drug.

Dr. Bradbury of Boston University School of Public Health and his associates based their analysis on data derived from the United Kingdom's General Practice Research Database. Since 1987, more than 3 million U.K. residents have been enrolled in the database (Cancer 2005;103:1114-21).

The researchers matched 3,030 women aged 30-85 years with a first-time diagnosis of breast cancer treated with tamoxifen with 4,233 controls who had other cancers (bladder, colorectal, and nonmelanoma skin cancer). Women with a history of heart attack, angina pectoris, and HIV/acquired immunodeficiency syndrome were excluded. The median follow-up for all women was about 2 years. Of a total of 154 cases of ischemic heart disease, women with breast cancer had a reduced rate of heart disease, compared with women with the other cancers (hazard ratio=0.5).

The investigators then matched 585 of the controls to 151 of the women with heart disease. The women with heart disease were more likely to be obese, to be former smokers, and to have been treated for hypertension, compared with the controls. Current use of tamoxifen was associated with a 60% decreased risk of heart disease. When myocardial infarction and angina were assessed separately, the decreased risk for current tamoxifen users was 80% for MI and 60% for treated angina.

The protective effect lasted throughout the 5-year treatment period, with a 60% decreased risk for the first 4 years and a 50% decreased risk thereafter.

Women who took tamoxifen for breast cancer had a 60% decreased risk of developing ischemic heart disease during 5 years of treatment, compared with women who had other cancers not treated with tamoxifen, Brian D. Bradbury, D.Sc., and his colleagues reported.

The large case-control study supports other recent studies showing that tamoxifen has a beneficial effect on low-density lipoprotein and total cholesterol levels in postmenopausal women taking the drug.

Dr. Bradbury of Boston University School of Public Health and his associates based their analysis on data derived from the United Kingdom's General Practice Research Database. Since 1987, more than 3 million U.K. residents have been enrolled in the database (Cancer 2005;103:1114-21).

The researchers matched 3,030 women aged 30-85 years with a first-time diagnosis of breast cancer treated with tamoxifen with 4,233 controls who had other cancers (bladder, colorectal, and nonmelanoma skin cancer). Women with a history of heart attack, angina pectoris, and HIV/acquired immunodeficiency syndrome were excluded. The median follow-up for all women was about 2 years. Of a total of 154 cases of ischemic heart disease, women with breast cancer had a reduced rate of heart disease, compared with women with the other cancers (hazard ratio=0.5).

The investigators then matched 585 of the controls to 151 of the women with heart disease. The women with heart disease were more likely to be obese, to be former smokers, and to have been treated for hypertension, compared with the controls. Current use of tamoxifen was associated with a 60% decreased risk of heart disease. When myocardial infarction and angina were assessed separately, the decreased risk for current tamoxifen users was 80% for MI and 60% for treated angina.

The protective effect lasted throughout the 5-year treatment period, with a 60% decreased risk for the first 4 years and a 50% decreased risk thereafter.

Drotrecogin alfa, a biologic agent used to treat adults with severe sepsis who are at high risk of death, may not be appropriate for patients with single organ dysfunction and recent surgery, and should be administered only after careful consideration of the potential risks and benefits, according to a new warning by Eli Lilly & Co., which manufactures the drug.

Lilly added the warning to the prescribing information after two studies indicated a small but clinically important increase in the rate of all-cause mortality among these patients treated with the agent, compared with those who received placebo. Physicians and other health care providers received a letter in February alerting them to the new warning.

Drotrecogin alfa (Xigris) is indicated only for adult patients with severe sepsis who are at high risk of death. The subset of patients with single organ dysfunction and recent surgery, “may not be at high risk of death, and therefore may not be indicated for Xigris,” the warning states.

The warning was based on a preliminary analysis of the Administration of Drotrecogin Alfa [Activated] Early Stage Severe Sepsis (ADDRESS) randomized, placebo-controlled trial and a reanalysis of Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS), the drug's phase III registration trial. In the PROWESS trial of almost 1,700 patients, only 98 had single organ dysfunction and recent surgery (within 30 days of therapy). Among the 49 treated patients, 10 died within 28 days of treatment and 14 were hospitalized; among the patients treated with placebo, eight died within 28 days and eight were hospitalized.

The ADDRESS trial studied the drug's effect in patients who were less critically ill (Acute Physiology and Chronic Health Evaluation [APACHE] II score less than 25, or single sepsis-induced organ failure at any APACHE II score). Among 323 treated patients, 67 died within 28 days and 76 were hospitalized; among the placebo-treated patients, 44 died within 28 days and 62 were hospitalized.

“The important thing to note is that this is a preliminary finding,” said Carole Puls, spokesperson for Lilly. “We issued the warning because we felt these patients may not be at high risk for death and so the drug is not indicated for them.”

During Food and Drug Administration approval hearings for drotrecogin alfa, members of the Anti-Infective Drugs Advisory Committee noted that the drug was less effective in reducing mortality in patients with less severe sepsis, who had a better prognosis.

The main safety concern during the hearings was serious bleeding events, which the company said appeared to be associated with vessel trauma or severe coagulopathy and were consistent with the product's antithrombotic and profibrinolytic effects. Serious bleeding adverse events occurred in 3.5% of those on drotrecogin alfa, compared with 2% of those on placebo. Of the serious bleeding events among those on drotrecogin alfa, most occurred during or immediately after the patients received the infusion. Bleeding sites were gastrointestinal, intraabdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, and skin/soft tissue.

Drotrecogin alfa is a genetically engineered version of human activated protein C. This molecule is a naturally occurring protein that, when activated, promotes fibrinolysis, inhibits thrombosis and inflammation, and is an important modulator of the coagulation and inflammation associated with severe sepsis, according to Lilly. Evidence suggests that the process that activates the molecule may be impaired by sepsis, and therefore, septic patients have low levels of activated protein C.

Drotrecogin alfa, a biologic agent used to treat adults with severe sepsis who are at high risk of death, may not be appropriate for patients with single organ dysfunction and recent surgery, and should be administered only after careful consideration of the potential risks and benefits, according to a new warning by Eli Lilly & Co., which manufactures the drug.

Lilly added the warning to the prescribing information after two studies indicated a small but clinically important increase in the rate of all-cause mortality among these patients treated with the agent, compared with those who received placebo. Physicians and other health care providers received a letter in February alerting them to the new warning.

Drotrecogin alfa (Xigris) is indicated only for adult patients with severe sepsis who are at high risk of death. The subset of patients with single organ dysfunction and recent surgery, “may not be at high risk of death, and therefore may not be indicated for Xigris,” the warning states.

The warning was based on a preliminary analysis of the Administration of Drotrecogin Alfa [Activated] Early Stage Severe Sepsis (ADDRESS) randomized, placebo-controlled trial and a reanalysis of Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS), the drug's phase III registration trial. In the PROWESS trial of almost 1,700 patients, only 98 had single organ dysfunction and recent surgery (within 30 days of therapy). Among the 49 treated patients, 10 died within 28 days of treatment and 14 were hospitalized; among the patients treated with placebo, eight died within 28 days and eight were hospitalized.

The ADDRESS trial studied the drug's effect in patients who were less critically ill (Acute Physiology and Chronic Health Evaluation [APACHE] II score less than 25, or single sepsis-induced organ failure at any APACHE II score). Among 323 treated patients, 67 died within 28 days and 76 were hospitalized; among the placebo-treated patients, 44 died within 28 days and 62 were hospitalized.

“The important thing to note is that this is a preliminary finding,” said Carole Puls, spokesperson for Lilly. “We issued the warning because we felt these patients may not be at high risk for death and so the drug is not indicated for them.”

During Food and Drug Administration approval hearings for drotrecogin alfa, members of the Anti-Infective Drugs Advisory Committee noted that the drug was less effective in reducing mortality in patients with less severe sepsis, who had a better prognosis.

The main safety concern during the hearings was serious bleeding events, which the company said appeared to be associated with vessel trauma or severe coagulopathy and were consistent with the product's antithrombotic and profibrinolytic effects. Serious bleeding adverse events occurred in 3.5% of those on drotrecogin alfa, compared with 2% of those on placebo. Of the serious bleeding events among those on drotrecogin alfa, most occurred during or immediately after the patients received the infusion. Bleeding sites were gastrointestinal, intraabdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, and skin/soft tissue.

Drotrecogin alfa is a genetically engineered version of human activated protein C. This molecule is a naturally occurring protein that, when activated, promotes fibrinolysis, inhibits thrombosis and inflammation, and is an important modulator of the coagulation and inflammation associated with severe sepsis, according to Lilly. Evidence suggests that the process that activates the molecule may be impaired by sepsis, and therefore, septic patients have low levels of activated protein C.

Drotrecogin alfa, a biologic agent used to treat adults with severe sepsis who are at high risk of death, may not be appropriate for patients with single organ dysfunction and recent surgery, and should be administered only after careful consideration of the potential risks and benefits, according to a new warning by Eli Lilly & Co., which manufactures the drug.

Lilly added the warning to the prescribing information after two studies indicated a small but clinically important increase in the rate of all-cause mortality among these patients treated with the agent, compared with those who received placebo. Physicians and other health care providers received a letter in February alerting them to the new warning.

Drotrecogin alfa (Xigris) is indicated only for adult patients with severe sepsis who are at high risk of death. The subset of patients with single organ dysfunction and recent surgery, “may not be at high risk of death, and therefore may not be indicated for Xigris,” the warning states.

The warning was based on a preliminary analysis of the Administration of Drotrecogin Alfa [Activated] Early Stage Severe Sepsis (ADDRESS) randomized, placebo-controlled trial and a reanalysis of Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS), the drug's phase III registration trial. In the PROWESS trial of almost 1,700 patients, only 98 had single organ dysfunction and recent surgery (within 30 days of therapy). Among the 49 treated patients, 10 died within 28 days of treatment and 14 were hospitalized; among the patients treated with placebo, eight died within 28 days and eight were hospitalized.

The ADDRESS trial studied the drug's effect in patients who were less critically ill (Acute Physiology and Chronic Health Evaluation [APACHE] II score less than 25, or single sepsis-induced organ failure at any APACHE II score). Among 323 treated patients, 67 died within 28 days and 76 were hospitalized; among the placebo-treated patients, 44 died within 28 days and 62 were hospitalized.

“The important thing to note is that this is a preliminary finding,” said Carole Puls, spokesperson for Lilly. “We issued the warning because we felt these patients may not be at high risk for death and so the drug is not indicated for them.”

During Food and Drug Administration approval hearings for drotrecogin alfa, members of the Anti-Infective Drugs Advisory Committee noted that the drug was less effective in reducing mortality in patients with less severe sepsis, who had a better prognosis.

The main safety concern during the hearings was serious bleeding events, which the company said appeared to be associated with vessel trauma or severe coagulopathy and were consistent with the product's antithrombotic and profibrinolytic effects. Serious bleeding adverse events occurred in 3.5% of those on drotrecogin alfa, compared with 2% of those on placebo. Of the serious bleeding events among those on drotrecogin alfa, most occurred during or immediately after the patients received the infusion. Bleeding sites were gastrointestinal, intraabdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, and skin/soft tissue.

Drotrecogin alfa is a genetically engineered version of human activated protein C. This molecule is a naturally occurring protein that, when activated, promotes fibrinolysis, inhibits thrombosis and inflammation, and is an important modulator of the coagulation and inflammation associated with severe sepsis, according to Lilly. Evidence suggests that the process that activates the molecule may be impaired by sepsis, and therefore, septic patients have low levels of activated protein C.

SAVANNAH, GA. — Any patient who presents with the neurologic symptoms of acute-onset weakness or paralysis during mosquito season should be evaluated for West Nile virus infection, regardless of whether there was a viral prodrome.

Only about 1% of West Nile patients develop symptoms, but about 21% of that group develop a neurologic complication. Recovery is highly variable and almost impossible to predict, two researchers said at the annual meeting of the American Association of Electrodiagnostic Medicine.

An early and virulent season for West Nile virus infection has been predicted for California and the southwestern United States by the Centers for Disease Control and Prevention's division of vector-borne infectious diseases. The culprit: a wetter-than-normal winter.

The International Society for Infectious Diseases has predicted a tough year for Oregon in terms of West Nile virus infection. The state saw 88 deaths from West Nile in 2004, according to CDC data. State public health officials are meeting to develop control strategies (www.promedmail.org/pls/pm/pm?an=20050305.0670

“These paralytic illnesses are seen a lot in patients who are elderly, immunocompromised, or otherwise sick, but every once in a while you'll see them in a young, healthy patient,” said Bjorn Oskarsson, M.D.

“Severity of illness at onset isn't a good predictor of recovery,” noted Dr. Oskarsson, a neurologic fellow at the University of Colorado, Denver.

Weakness or paralysis associated with West Nile infection apparently occurs when the virus destroys motor neurons in the anterior horn of the spinal cord. Magnetic resonance imaging is generally unhelpful in symptomatic infection, but patients with paralytic illness often show abnormal signal intensity in the anterior horn, he said in a poster presentation.

Jun Li, M.D., said needle electromyography shows severe denervation in the muscles of weak limbs and their corresponding paraspinal muscles. The findings confirm the localization of the lesion to the anterior horn motor neurons or their ventral nerve roots.

“The cardinal clinical feature of these patients is acute asymmetric flaccid paralysis that reaches a plateau within hours in most patients,” said Dr. Li of the department of neurology at Wayne State University, Detroit. The paralysis is slightly more frequent in the lower extremities than in the upper, and there little or no sensory disturbance.

Many patients report a flu-like illness preceding onset of weakness by days or weeks, but this is not a certainty. Paralysis can occur in previously healthy individuals as well as those who are immunocompromised or those with chronic health problems.

West Nile virus has become endemic in most states, so the presence of IgM antibodies in serum is no longer an acceptable way of confirming the diagnosis, Dr. Li noted. Instead, the antibodies must be detected in cerebrospinal fluid by enzyme-linked immunosorbent assay.

Patients with a paralytic complication may also show increased serum creatine kinase, ranging from several hundred up to 20,000 mg/dL. “This elevated CK may have originated from necrotized muscle fibers,” Dr. Li said.

There is no current treatment for the condition, he noted. Intravenous immunoglobulin has been found ineffective.

Both Dr. Li and Dr. Oskarsson presented case studies illustrating the unpredictable nature of this illness.

Dr. Li presented two cases. A previously healthy 36-year-old woman developed a mild flu-like illness followed by low back pain. She then awoke to find her left leg paralyzed. She was unresponsive to a short course of intravenous immunoglobulin.

The second case was a previously healthy 44-year-old man who first noticed a tingling sensation in his back followed by a flu-like illness. Four days later, his legs suddenly became paralyzed. Ten days later, his right arm was paralyzed and within another 24 hours, the left arm was also paralyzed. He also developed bilateral facial muscle weakness.

These two patients illustrate the unpredictable outcomes of this illness, Dr. Li noted. The man had more systemic symptoms and severe four-limb paralysis. His condition appeared much worse than that of the woman. Yet his strength recovered completely, while the woman's leg paralysis improved only minimally after 20 months.

Dr. Oskarsson presented five cases; three involved immunocompromise.

One patient died. She was a 46-year-old woman with a history of bone marrow transplant for large cell lymphoma. She presented with generalized weakness after a flu-like illness. She rapidly became comatose. Her brain MRI showed severe panencephalitic changes with multifocal necrosis in the cerebral deep gray nuclei, brainstem, and spinal cord.

The other patients survived, but only one regained baseline strength: a 48-year old woman with a prior kidney transplant. A month after developing gastroenteritis she became confused and developed proximal bilateral arm weakness.

The other three patients survived but with neurologic deficits: a previously healthy 54-year-old woman who developed paraplegia after a flu-like illness; a previously healthy 32-year-old woman who developed left arm, face, and leg weakness after 3 days of severe headache and truncal rash; and a 50-year-old man with a liver transplant who developed rapidly progressive quadriplegia after severe ab-dominal pain and encephalopathy.

Symptoms arise from damage (arrow) to motor neurons in the anterior horn of the spine. Courtesy B. Kleinschmidt-DeMasters

SAVANNAH, GA. — Any patient who presents with the neurologic symptoms of acute-onset weakness or paralysis during mosquito season should be evaluated for West Nile virus infection, regardless of whether there was a viral prodrome.

Only about 1% of West Nile patients develop symptoms, but about 21% of that group develop a neurologic complication. Recovery is highly variable and almost impossible to predict, two researchers said at the annual meeting of the American Association of Electrodiagnostic Medicine.

An early and virulent season for West Nile virus infection has been predicted for California and the southwestern United States by the Centers for Disease Control and Prevention's division of vector-borne infectious diseases. The culprit: a wetter-than-normal winter.

The International Society for Infectious Diseases has predicted a tough year for Oregon in terms of West Nile virus infection. The state saw 88 deaths from West Nile in 2004, according to CDC data. State public health officials are meeting to develop control strategies (www.promedmail.org/pls/pm/pm?an=20050305.0670

“These paralytic illnesses are seen a lot in patients who are elderly, immunocompromised, or otherwise sick, but every once in a while you'll see them in a young, healthy patient,” said Bjorn Oskarsson, M.D.

“Severity of illness at onset isn't a good predictor of recovery,” noted Dr. Oskarsson, a neurologic fellow at the University of Colorado, Denver.

Weakness or paralysis associated with West Nile infection apparently occurs when the virus destroys motor neurons in the anterior horn of the spinal cord. Magnetic resonance imaging is generally unhelpful in symptomatic infection, but patients with paralytic illness often show abnormal signal intensity in the anterior horn, he said in a poster presentation.

Jun Li, M.D., said needle electromyography shows severe denervation in the muscles of weak limbs and their corresponding paraspinal muscles. The findings confirm the localization of the lesion to the anterior horn motor neurons or their ventral nerve roots.

“The cardinal clinical feature of these patients is acute asymmetric flaccid paralysis that reaches a plateau within hours in most patients,” said Dr. Li of the department of neurology at Wayne State University, Detroit. The paralysis is slightly more frequent in the lower extremities than in the upper, and there little or no sensory disturbance.

Many patients report a flu-like illness preceding onset of weakness by days or weeks, but this is not a certainty. Paralysis can occur in previously healthy individuals as well as those who are immunocompromised or those with chronic health problems.

West Nile virus has become endemic in most states, so the presence of IgM antibodies in serum is no longer an acceptable way of confirming the diagnosis, Dr. Li noted. Instead, the antibodies must be detected in cerebrospinal fluid by enzyme-linked immunosorbent assay.

Patients with a paralytic complication may also show increased serum creatine kinase, ranging from several hundred up to 20,000 mg/dL. “This elevated CK may have originated from necrotized muscle fibers,” Dr. Li said.

There is no current treatment for the condition, he noted. Intravenous immunoglobulin has been found ineffective.

Both Dr. Li and Dr. Oskarsson presented case studies illustrating the unpredictable nature of this illness.

Dr. Li presented two cases. A previously healthy 36-year-old woman developed a mild flu-like illness followed by low back pain. She then awoke to find her left leg paralyzed. She was unresponsive to a short course of intravenous immunoglobulin.

The second case was a previously healthy 44-year-old man who first noticed a tingling sensation in his back followed by a flu-like illness. Four days later, his legs suddenly became paralyzed. Ten days later, his right arm was paralyzed and within another 24 hours, the left arm was also paralyzed. He also developed bilateral facial muscle weakness.

These two patients illustrate the unpredictable outcomes of this illness, Dr. Li noted. The man had more systemic symptoms and severe four-limb paralysis. His condition appeared much worse than that of the woman. Yet his strength recovered completely, while the woman's leg paralysis improved only minimally after 20 months.

Dr. Oskarsson presented five cases; three involved immunocompromise.

One patient died. She was a 46-year-old woman with a history of bone marrow transplant for large cell lymphoma. She presented with generalized weakness after a flu-like illness. She rapidly became comatose. Her brain MRI showed severe panencephalitic changes with multifocal necrosis in the cerebral deep gray nuclei, brainstem, and spinal cord.

The other patients survived, but only one regained baseline strength: a 48-year old woman with a prior kidney transplant. A month after developing gastroenteritis she became confused and developed proximal bilateral arm weakness.

The other three patients survived but with neurologic deficits: a previously healthy 54-year-old woman who developed paraplegia after a flu-like illness; a previously healthy 32-year-old woman who developed left arm, face, and leg weakness after 3 days of severe headache and truncal rash; and a 50-year-old man with a liver transplant who developed rapidly progressive quadriplegia after severe ab-dominal pain and encephalopathy.

Symptoms arise from damage (arrow) to motor neurons in the anterior horn of the spine. Courtesy B. Kleinschmidt-DeMasters

SAVANNAH, GA. — Any patient who presents with the neurologic symptoms of acute-onset weakness or paralysis during mosquito season should be evaluated for West Nile virus infection, regardless of whether there was a viral prodrome.

Only about 1% of West Nile patients develop symptoms, but about 21% of that group develop a neurologic complication. Recovery is highly variable and almost impossible to predict, two researchers said at the annual meeting of the American Association of Electrodiagnostic Medicine.

An early and virulent season for West Nile virus infection has been predicted for California and the southwestern United States by the Centers for Disease Control and Prevention's division of vector-borne infectious diseases. The culprit: a wetter-than-normal winter.

The International Society for Infectious Diseases has predicted a tough year for Oregon in terms of West Nile virus infection. The state saw 88 deaths from West Nile in 2004, according to CDC data. State public health officials are meeting to develop control strategies (www.promedmail.org/pls/pm/pm?an=20050305.0670

“These paralytic illnesses are seen a lot in patients who are elderly, immunocompromised, or otherwise sick, but every once in a while you'll see them in a young, healthy patient,” said Bjorn Oskarsson, M.D.

“Severity of illness at onset isn't a good predictor of recovery,” noted Dr. Oskarsson, a neurologic fellow at the University of Colorado, Denver.

Weakness or paralysis associated with West Nile infection apparently occurs when the virus destroys motor neurons in the anterior horn of the spinal cord. Magnetic resonance imaging is generally unhelpful in symptomatic infection, but patients with paralytic illness often show abnormal signal intensity in the anterior horn, he said in a poster presentation.

Jun Li, M.D., said needle electromyography shows severe denervation in the muscles of weak limbs and their corresponding paraspinal muscles. The findings confirm the localization of the lesion to the anterior horn motor neurons or their ventral nerve roots.

“The cardinal clinical feature of these patients is acute asymmetric flaccid paralysis that reaches a plateau within hours in most patients,” said Dr. Li of the department of neurology at Wayne State University, Detroit. The paralysis is slightly more frequent in the lower extremities than in the upper, and there little or no sensory disturbance.

Many patients report a flu-like illness preceding onset of weakness by days or weeks, but this is not a certainty. Paralysis can occur in previously healthy individuals as well as those who are immunocompromised or those with chronic health problems.

West Nile virus has become endemic in most states, so the presence of IgM antibodies in serum is no longer an acceptable way of confirming the diagnosis, Dr. Li noted. Instead, the antibodies must be detected in cerebrospinal fluid by enzyme-linked immunosorbent assay.

Patients with a paralytic complication may also show increased serum creatine kinase, ranging from several hundred up to 20,000 mg/dL. “This elevated CK may have originated from necrotized muscle fibers,” Dr. Li said.

There is no current treatment for the condition, he noted. Intravenous immunoglobulin has been found ineffective.

Both Dr. Li and Dr. Oskarsson presented case studies illustrating the unpredictable nature of this illness.

Dr. Li presented two cases. A previously healthy 36-year-old woman developed a mild flu-like illness followed by low back pain. She then awoke to find her left leg paralyzed. She was unresponsive to a short course of intravenous immunoglobulin.

The second case was a previously healthy 44-year-old man who first noticed a tingling sensation in his back followed by a flu-like illness. Four days later, his legs suddenly became paralyzed. Ten days later, his right arm was paralyzed and within another 24 hours, the left arm was also paralyzed. He also developed bilateral facial muscle weakness.

These two patients illustrate the unpredictable outcomes of this illness, Dr. Li noted. The man had more systemic symptoms and severe four-limb paralysis. His condition appeared much worse than that of the woman. Yet his strength recovered completely, while the woman's leg paralysis improved only minimally after 20 months.

Dr. Oskarsson presented five cases; three involved immunocompromise.

One patient died. She was a 46-year-old woman with a history of bone marrow transplant for large cell lymphoma. She presented with generalized weakness after a flu-like illness. She rapidly became comatose. Her brain MRI showed severe panencephalitic changes with multifocal necrosis in the cerebral deep gray nuclei, brainstem, and spinal cord.

The other patients survived, but only one regained baseline strength: a 48-year old woman with a prior kidney transplant. A month after developing gastroenteritis she became confused and developed proximal bilateral arm weakness.

The other three patients survived but with neurologic deficits: a previously healthy 54-year-old woman who developed paraplegia after a flu-like illness; a previously healthy 32-year-old woman who developed left arm, face, and leg weakness after 3 days of severe headache and truncal rash; and a 50-year-old man with a liver transplant who developed rapidly progressive quadriplegia after severe ab-dominal pain and encephalopathy.

Symptoms arise from damage (arrow) to motor neurons in the anterior horn of the spine. Courtesy B. Kleinschmidt-DeMasters

During just 1 year, Colorado's statewide after-hours call-in system handled almost 142,000 night and weekend calls from parents and other caregivers seeking medical advice for children, Shira Belman, M.D., and colleagues reported.

Although 88% of the calls were for clinical illness, almost half of those were not medically urgent and resulted in advice on in-home care of the child. About 5% of the total calls were for information only, said Dr. Belman of the University of Colorado and her associates (Arch. Pediatr. Adolesc. Med. 2005;159:145-9).

Many of these calls might be averted “if more anticipatory information was provided in the physician's office or [if] parents were directed to other sources of information available after hours,” they wrote. “Investing in such alternatives should be especially appealing to physicians who answer their own after-hours calls or who pay out-of-pocket per call for a call center's services.”

The investigators analyzed all calls placed to the After Hours Telephone Care Program in Denver from June 1999 to July 2000. The center provides after-hours telephone triage to 90% of all Colorado pediatricians and is staffed by registered nurses who follow computerized triage algorithms. Calls result in advice to call 911, to seek urgent care, to contact the pediatrician within 24 hours, to contact the pediatrician within 72 hours, or to care for the child at home.

The 10 most common algorithms used were for vomiting (8.4% of all calls), colds (6%), cough (6%), earache (6%), fever (4%), sore throat (4%), diarrhea (3.4%), croup (3%), head trauma (2.6%), and eye infection (2.5%).

Only 21% of the callers were directed to seek urgent care, with only 1% of those told to call 911. Forty-five percent were advised how to care for the child at home; 30% were told to call their pediatrician the next day.

A small percentage of calls (5%) were for information only, including requests for the correct dose of over-the-counter medications, medication refill requests, questions about whether a condition was contagious, and calls to ask if certain medications could be administered simultaneously.

The highest volume of calls (29%) occurred in winter and the lowest (20%) in summer. Spring and fall had roughly equal volume (about 25% each).

During just 1 year, Colorado's statewide after-hours call-in system handled almost 142,000 night and weekend calls from parents and other caregivers seeking medical advice for children, Shira Belman, M.D., and colleagues reported.

Although 88% of the calls were for clinical illness, almost half of those were not medically urgent and resulted in advice on in-home care of the child. About 5% of the total calls were for information only, said Dr. Belman of the University of Colorado and her associates (Arch. Pediatr. Adolesc. Med. 2005;159:145-9).

Many of these calls might be averted “if more anticipatory information was provided in the physician's office or [if] parents were directed to other sources of information available after hours,” they wrote. “Investing in such alternatives should be especially appealing to physicians who answer their own after-hours calls or who pay out-of-pocket per call for a call center's services.”

The investigators analyzed all calls placed to the After Hours Telephone Care Program in Denver from June 1999 to July 2000. The center provides after-hours telephone triage to 90% of all Colorado pediatricians and is staffed by registered nurses who follow computerized triage algorithms. Calls result in advice to call 911, to seek urgent care, to contact the pediatrician within 24 hours, to contact the pediatrician within 72 hours, or to care for the child at home.

The 10 most common algorithms used were for vomiting (8.4% of all calls), colds (6%), cough (6%), earache (6%), fever (4%), sore throat (4%), diarrhea (3.4%), croup (3%), head trauma (2.6%), and eye infection (2.5%).

Only 21% of the callers were directed to seek urgent care, with only 1% of those told to call 911. Forty-five percent were advised how to care for the child at home; 30% were told to call their pediatrician the next day.

A small percentage of calls (5%) were for information only, including requests for the correct dose of over-the-counter medications, medication refill requests, questions about whether a condition was contagious, and calls to ask if certain medications could be administered simultaneously.

The highest volume of calls (29%) occurred in winter and the lowest (20%) in summer. Spring and fall had roughly equal volume (about 25% each).

During just 1 year, Colorado's statewide after-hours call-in system handled almost 142,000 night and weekend calls from parents and other caregivers seeking medical advice for children, Shira Belman, M.D., and colleagues reported.

Although 88% of the calls were for clinical illness, almost half of those were not medically urgent and resulted in advice on in-home care of the child. About 5% of the total calls were for information only, said Dr. Belman of the University of Colorado and her associates (Arch. Pediatr. Adolesc. Med. 2005;159:145-9).

Many of these calls might be averted “if more anticipatory information was provided in the physician's office or [if] parents were directed to other sources of information available after hours,” they wrote. “Investing in such alternatives should be especially appealing to physicians who answer their own after-hours calls or who pay out-of-pocket per call for a call center's services.”

The investigators analyzed all calls placed to the After Hours Telephone Care Program in Denver from June 1999 to July 2000. The center provides after-hours telephone triage to 90% of all Colorado pediatricians and is staffed by registered nurses who follow computerized triage algorithms. Calls result in advice to call 911, to seek urgent care, to contact the pediatrician within 24 hours, to contact the pediatrician within 72 hours, or to care for the child at home.

The 10 most common algorithms used were for vomiting (8.4% of all calls), colds (6%), cough (6%), earache (6%), fever (4%), sore throat (4%), diarrhea (3.4%), croup (3%), head trauma (2.6%), and eye infection (2.5%).

Only 21% of the callers were directed to seek urgent care, with only 1% of those told to call 911. Forty-five percent were advised how to care for the child at home; 30% were told to call their pediatrician the next day.

A small percentage of calls (5%) were for information only, including requests for the correct dose of over-the-counter medications, medication refill requests, questions about whether a condition was contagious, and calls to ask if certain medications could be administered simultaneously.

The highest volume of calls (29%) occurred in winter and the lowest (20%) in summer. Spring and fall had roughly equal volume (about 25% each).

Parents of adolescents appear to accept the idea of vaccinating their teens against sexually transmitted infections, expressing the most concern about the efficacy of the vaccine and the severity of the infection it could prevent, rather than the mode of transmission, Gregory D. Zimet, Ph.D., and his colleagues have reported.

Some surveys have suggested that pediatricians and other adolescent health providers might be reluctant to recommend STI vaccines, perhaps because of concerns about how parents might react. “The high acceptability ratings reported by most parents in this study suggest that most parents would not react negatively to the suggestion,” said Dr. Zimet of Indiana University, Indianapolis (Arch. Pediatr. Adolesc. Med. 2005;159:132-7).

The researchers surveyed 278 parents of adolescents aged 12-17 years. The mean age of parents was 41 years. The mean age of children was 14 years, and 69% were female.

The survey presented nine vaccine scenarios, each of which uniquely defined four variables: mode of transmission (STI or non-STI), severity of infection (curable, chronic and incurable, usually fatal); vaccine efficacy (50%, 70%, or 90%); and availability of behavioral methods of prevention (such as condoms or hand washing).

For each scenario, parents were asked, “If this vaccine were available today and you had the time, would you let your child get vaccinated?” Parents rated acceptability on a scale of 0-100, with 100 being “I would definitely let my child get this vaccine.”

The parents were recruited from urban, Midwestern adolescent medicine clinics and private practices. More than half (56%) were white, about 40% were African American, and less than 2% were Hispanic.

The least acceptable scenario, with a mean score of about 75, was a vaccine with 50% efficacy against a non-STI that could be prevented by hand washing. The most acceptable scenario, with a mean score of 88.6, was a vaccine with 90% efficacy that protected against a usually fatal non-STI that could not be prevented by hand washing.

The mean score for the six STI scenarios was slightly, but not significantly, higher than the mean score for the three non-STI scenarios. The lowest-scoring STI vaccine scenario was a vaccine that was 50% effective against a curable STI that could not be prevented with condoms (75.7). The highest-scoring STI scenario was a vaccine that was 70% effective in preventing a usually fatal STI that could be prevented by the use of condoms (84.4).

For the majority of parents, sexual transmissibility had the least influence on acceptability ratings. Vaccine efficacy was the most influential factor in the ratings, followed by severity of infection and availability of behavioral protection. However, 31 parents (11%) indicated a relatively strong preference for an STI vaccine, and 16 parents (6%) indicated a relatively strong opposition to it.

About a quarter (27%) of the parents gave ratings of 100 to every vaccine. High accepters were more likely to be in the urban clinics and to have only a high school diploma. Acceptability was not related to the child's age, suggesting parents might not make these decisions based on the proximity of their child's sexual activity.

In an accompanying editorial, Susan L. Rosenthal, Ph.D., of the University of Texas, Galveston, said questions remain, not only about STI vaccine acceptability, but how to maximize its use to offer the broadest protection. The study involved mostly white, Midwestern parents, so results can't be extrapolated to other groups. It also doesn't address provider feelings about the child's age—which will invariably affect who gets vaccinated, and when. “It will be important to understand how the age of the child or adolescent will influence parents' and health care professionals' attitudes, including assessing the acceptability of vaccinating even younger children” (Arch. Pediatr. Adolesc. Med. 2005:159;190-2).

Parents of adolescents appear to accept the idea of vaccinating their teens against sexually transmitted infections, expressing the most concern about the efficacy of the vaccine and the severity of the infection it could prevent, rather than the mode of transmission, Gregory D. Zimet, Ph.D., and his colleagues have reported.

Some surveys have suggested that pediatricians and other adolescent health providers might be reluctant to recommend STI vaccines, perhaps because of concerns about how parents might react. “The high acceptability ratings reported by most parents in this study suggest that most parents would not react negatively to the suggestion,” said Dr. Zimet of Indiana University, Indianapolis (Arch. Pediatr. Adolesc. Med. 2005;159:132-7).

The researchers surveyed 278 parents of adolescents aged 12-17 years. The mean age of parents was 41 years. The mean age of children was 14 years, and 69% were female.

The survey presented nine vaccine scenarios, each of which uniquely defined four variables: mode of transmission (STI or non-STI), severity of infection (curable, chronic and incurable, usually fatal); vaccine efficacy (50%, 70%, or 90%); and availability of behavioral methods of prevention (such as condoms or hand washing).

For each scenario, parents were asked, “If this vaccine were available today and you had the time, would you let your child get vaccinated?” Parents rated acceptability on a scale of 0-100, with 100 being “I would definitely let my child get this vaccine.”

The parents were recruited from urban, Midwestern adolescent medicine clinics and private practices. More than half (56%) were white, about 40% were African American, and less than 2% were Hispanic.

The least acceptable scenario, with a mean score of about 75, was a vaccine with 50% efficacy against a non-STI that could be prevented by hand washing. The most acceptable scenario, with a mean score of 88.6, was a vaccine with 90% efficacy that protected against a usually fatal non-STI that could not be prevented by hand washing.

The mean score for the six STI scenarios was slightly, but not significantly, higher than the mean score for the three non-STI scenarios. The lowest-scoring STI vaccine scenario was a vaccine that was 50% effective against a curable STI that could not be prevented with condoms (75.7). The highest-scoring STI scenario was a vaccine that was 70% effective in preventing a usually fatal STI that could be prevented by the use of condoms (84.4).

For the majority of parents, sexual transmissibility had the least influence on acceptability ratings. Vaccine efficacy was the most influential factor in the ratings, followed by severity of infection and availability of behavioral protection. However, 31 parents (11%) indicated a relatively strong preference for an STI vaccine, and 16 parents (6%) indicated a relatively strong opposition to it.

About a quarter (27%) of the parents gave ratings of 100 to every vaccine. High accepters were more likely to be in the urban clinics and to have only a high school diploma. Acceptability was not related to the child's age, suggesting parents might not make these decisions based on the proximity of their child's sexual activity.

In an accompanying editorial, Susan L. Rosenthal, Ph.D., of the University of Texas, Galveston, said questions remain, not only about STI vaccine acceptability, but how to maximize its use to offer the broadest protection. The study involved mostly white, Midwestern parents, so results can't be extrapolated to other groups. It also doesn't address provider feelings about the child's age—which will invariably affect who gets vaccinated, and when. “It will be important to understand how the age of the child or adolescent will influence parents' and health care professionals' attitudes, including assessing the acceptability of vaccinating even younger children” (Arch. Pediatr. Adolesc. Med. 2005:159;190-2).

Parents of adolescents appear to accept the idea of vaccinating their teens against sexually transmitted infections, expressing the most concern about the efficacy of the vaccine and the severity of the infection it could prevent, rather than the mode of transmission, Gregory D. Zimet, Ph.D., and his colleagues have reported.

Some surveys have suggested that pediatricians and other adolescent health providers might be reluctant to recommend STI vaccines, perhaps because of concerns about how parents might react. “The high acceptability ratings reported by most parents in this study suggest that most parents would not react negatively to the suggestion,” said Dr. Zimet of Indiana University, Indianapolis (Arch. Pediatr. Adolesc. Med. 2005;159:132-7).

The researchers surveyed 278 parents of adolescents aged 12-17 years. The mean age of parents was 41 years. The mean age of children was 14 years, and 69% were female.

The survey presented nine vaccine scenarios, each of which uniquely defined four variables: mode of transmission (STI or non-STI), severity of infection (curable, chronic and incurable, usually fatal); vaccine efficacy (50%, 70%, or 90%); and availability of behavioral methods of prevention (such as condoms or hand washing).

For each scenario, parents were asked, “If this vaccine were available today and you had the time, would you let your child get vaccinated?” Parents rated acceptability on a scale of 0-100, with 100 being “I would definitely let my child get this vaccine.”

The parents were recruited from urban, Midwestern adolescent medicine clinics and private practices. More than half (56%) were white, about 40% were African American, and less than 2% were Hispanic.

The least acceptable scenario, with a mean score of about 75, was a vaccine with 50% efficacy against a non-STI that could be prevented by hand washing. The most acceptable scenario, with a mean score of 88.6, was a vaccine with 90% efficacy that protected against a usually fatal non-STI that could not be prevented by hand washing.

The mean score for the six STI scenarios was slightly, but not significantly, higher than the mean score for the three non-STI scenarios. The lowest-scoring STI vaccine scenario was a vaccine that was 50% effective against a curable STI that could not be prevented with condoms (75.7). The highest-scoring STI scenario was a vaccine that was 70% effective in preventing a usually fatal STI that could be prevented by the use of condoms (84.4).

For the majority of parents, sexual transmissibility had the least influence on acceptability ratings. Vaccine efficacy was the most influential factor in the ratings, followed by severity of infection and availability of behavioral protection. However, 31 parents (11%) indicated a relatively strong preference for an STI vaccine, and 16 parents (6%) indicated a relatively strong opposition to it.

About a quarter (27%) of the parents gave ratings of 100 to every vaccine. High accepters were more likely to be in the urban clinics and to have only a high school diploma. Acceptability was not related to the child's age, suggesting parents might not make these decisions based on the proximity of their child's sexual activity.

In an accompanying editorial, Susan L. Rosenthal, Ph.D., of the University of Texas, Galveston, said questions remain, not only about STI vaccine acceptability, but how to maximize its use to offer the broadest protection. The study involved mostly white, Midwestern parents, so results can't be extrapolated to other groups. It also doesn't address provider feelings about the child's age—which will invariably affect who gets vaccinated, and when. “It will be important to understand how the age of the child or adolescent will influence parents' and health care professionals' attitudes, including assessing the acceptability of vaccinating even younger children” (Arch. Pediatr. Adolesc. Med. 2005:159;190-2).

Drotrecogin alfa, a biologic agent used to treat adults with severe sepsis who are at high risk of death, may not be appropriate for patients with single organ dysfunction and recent surgery, and should only be administered after careful consideration of the potential risks and benefits, according to a new warning by Eli Lilly & Co., which manufactures the drug.

Lilly added the warning to the prescribing information after two studies indicated a small but clinically important increase in the rate of all-cause mortality among these patients treated with the agent, compared with those who received placebo. Physicians and other health care providers received a letter in February alerting them to the new warning.

Drotrecogin alfa (Xigris) is indicated only for adult patients with severe sepsis who are at high risk of death. The subset of patients with single organ dysfunction and recent surgery, “may not be at high risk of death, and therefore may not be indicated for Xigris,” the warning states.

The warning was based on a preliminary analysis of the Administration of Drotrecogin Alfa [Activated] Early Stage Severe Sepsis (ADDRESS) randomized, placebo-controlled trial and a reanalysis of Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS), the drug's phase III registration trial. In the PROWESS trial of almost 1,700 patients, only 98 had single organ dysfunction and recent surgery (within 30 days of therapy). Among the 49 treated patients, 10 died within 28 days of treatment and 14 were hospitalized; among the placebo-treated patients, 8 died within 28 days and 8 were hospitalized.

The ADDRESS trial studied the drug's effect in patients who were less critically ill (Acute Physiology and Chronic Health Evaluation [APACHE] II score less than 25, or single sepsis-induced organ failure at any APACHE II score). Among 323 treated patients, 67 died within 28 days and 76 were hospitalized; among the placebo-treated patients, 44 died within 28 days and 62 were hospitalized.

“The important thing to note is that this is a preliminary finding,” said Carole Puls, spokesperson for Lilly. “We issued the warning because we felt these patients may not be at high risk for death and so the drug is not indicated for them.”

During Food and Drug Administration approval hearings for drotrecogin alfa, members of the Anti-Infective Drugs Advisory Committee noted that the drug was less effective in reducing mortality in patients with less severe sepsis, who had a better prognosis.

The main safety concern during the hearings was serious bleeding events, which the company said appeared to be associated with vessel trauma or severe coagulopathy and were consistent with the product's antithrombotic and profibrinolytic effects. Serious bleeding adverse events occurred in 3.5% of those on drotrecogin alfa, compared with 2% of those on placebo. Of the serious bleeding events among those on drotrecogin alfa, most occurred during or immediately after the patients received the infusion. Bleeding sites were gastrointestinal, intraabdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, and skin/soft tissue.

Drotrecogin alfa, a biologic agent used to treat adults with severe sepsis who are at high risk of death, may not be appropriate for patients with single organ dysfunction and recent surgery, and should only be administered after careful consideration of the potential risks and benefits, according to a new warning by Eli Lilly & Co., which manufactures the drug.

Lilly added the warning to the prescribing information after two studies indicated a small but clinically important increase in the rate of all-cause mortality among these patients treated with the agent, compared with those who received placebo. Physicians and other health care providers received a letter in February alerting them to the new warning.

Drotrecogin alfa (Xigris) is indicated only for adult patients with severe sepsis who are at high risk of death. The subset of patients with single organ dysfunction and recent surgery, “may not be at high risk of death, and therefore may not be indicated for Xigris,” the warning states.

The warning was based on a preliminary analysis of the Administration of Drotrecogin Alfa [Activated] Early Stage Severe Sepsis (ADDRESS) randomized, placebo-controlled trial and a reanalysis of Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS), the drug's phase III registration trial. In the PROWESS trial of almost 1,700 patients, only 98 had single organ dysfunction and recent surgery (within 30 days of therapy). Among the 49 treated patients, 10 died within 28 days of treatment and 14 were hospitalized; among the placebo-treated patients, 8 died within 28 days and 8 were hospitalized.

The ADDRESS trial studied the drug's effect in patients who were less critically ill (Acute Physiology and Chronic Health Evaluation [APACHE] II score less than 25, or single sepsis-induced organ failure at any APACHE II score). Among 323 treated patients, 67 died within 28 days and 76 were hospitalized; among the placebo-treated patients, 44 died within 28 days and 62 were hospitalized.

“The important thing to note is that this is a preliminary finding,” said Carole Puls, spokesperson for Lilly. “We issued the warning because we felt these patients may not be at high risk for death and so the drug is not indicated for them.”

During Food and Drug Administration approval hearings for drotrecogin alfa, members of the Anti-Infective Drugs Advisory Committee noted that the drug was less effective in reducing mortality in patients with less severe sepsis, who had a better prognosis.

The main safety concern during the hearings was serious bleeding events, which the company said appeared to be associated with vessel trauma or severe coagulopathy and were consistent with the product's antithrombotic and profibrinolytic effects. Serious bleeding adverse events occurred in 3.5% of those on drotrecogin alfa, compared with 2% of those on placebo. Of the serious bleeding events among those on drotrecogin alfa, most occurred during or immediately after the patients received the infusion. Bleeding sites were gastrointestinal, intraabdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, and skin/soft tissue.

Drotrecogin alfa, a biologic agent used to treat adults with severe sepsis who are at high risk of death, may not be appropriate for patients with single organ dysfunction and recent surgery, and should only be administered after careful consideration of the potential risks and benefits, according to a new warning by Eli Lilly & Co., which manufactures the drug.

Lilly added the warning to the prescribing information after two studies indicated a small but clinically important increase in the rate of all-cause mortality among these patients treated with the agent, compared with those who received placebo. Physicians and other health care providers received a letter in February alerting them to the new warning.

Drotrecogin alfa (Xigris) is indicated only for adult patients with severe sepsis who are at high risk of death. The subset of patients with single organ dysfunction and recent surgery, “may not be at high risk of death, and therefore may not be indicated for Xigris,” the warning states.

The warning was based on a preliminary analysis of the Administration of Drotrecogin Alfa [Activated] Early Stage Severe Sepsis (ADDRESS) randomized, placebo-controlled trial and a reanalysis of Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS), the drug's phase III registration trial. In the PROWESS trial of almost 1,700 patients, only 98 had single organ dysfunction and recent surgery (within 30 days of therapy). Among the 49 treated patients, 10 died within 28 days of treatment and 14 were hospitalized; among the placebo-treated patients, 8 died within 28 days and 8 were hospitalized.

The ADDRESS trial studied the drug's effect in patients who were less critically ill (Acute Physiology and Chronic Health Evaluation [APACHE] II score less than 25, or single sepsis-induced organ failure at any APACHE II score). Among 323 treated patients, 67 died within 28 days and 76 were hospitalized; among the placebo-treated patients, 44 died within 28 days and 62 were hospitalized.

“The important thing to note is that this is a preliminary finding,” said Carole Puls, spokesperson for Lilly. “We issued the warning because we felt these patients may not be at high risk for death and so the drug is not indicated for them.”

During Food and Drug Administration approval hearings for drotrecogin alfa, members of the Anti-Infective Drugs Advisory Committee noted that the drug was less effective in reducing mortality in patients with less severe sepsis, who had a better prognosis.

The main safety concern during the hearings was serious bleeding events, which the company said appeared to be associated with vessel trauma or severe coagulopathy and were consistent with the product's antithrombotic and profibrinolytic effects. Serious bleeding adverse events occurred in 3.5% of those on drotrecogin alfa, compared with 2% of those on placebo. Of the serious bleeding events among those on drotrecogin alfa, most occurred during or immediately after the patients received the infusion. Bleeding sites were gastrointestinal, intraabdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, and skin/soft tissue.

NEW ORLEANS – A head injury can cause immediate hypopituitarism that may last for up to 12 months and set the stage for new-onset pituitary deficiencies during that time, researchers said at the annual meeting of the Endocrine Society.

Neuroendocrine abnormalities are common in the acute phase of a traumatic brain injury (TBI), said Amar Agha, M.D., of Beaumont Hospital, Dublin, Ireland. Dr. Agha tested pituitary function in 50 TBI patients and 31 age-matched healthy controls and found that almost all patients had some form of pituitary dysfunction in the first 2 weeks after a mild or moderate brain injury.

All subjects had a glucagon stimulation test. For TBI patients, the test was performed within 12 days of the injury. Of the injured patients, 16% had subnormal peak cortisol responses and 18% had subnormal growth hormone responses; these findings were unrelated to age, body mass index, initial Glasgow Coma Score (GCS), or levels of insulinlike growth factor I.

A gonadotropin deficiency unrelated to the presence of hyperprolactinemia was seen in 80% of the injured patients. In males, low serum testosterone concentrations were associated with low (more severe) GCS scores.

Hyperprolactinemia was present in 52% of the patients. High serum prolactin levels were associated with low GCS scores. Cranial diabetes insipidus was present in 26% of the patients, and 14% had inappropriate antidiuretic hormone secretion.

“Recognition of post-head injury hypopituitarism is important, as undiagnosed hormone deficiencies may have serious consequences,” Dr. Agha said. “Appropriate and timely hormone replacement in affected patients may accelerate recovery and improve prognosis.”

Whether these abnormalities are permanent remains unclear, Dr. Agha said. But even though some pituitary dysfunction resulting from traumatic brain injury is transient, total hypopituitarism diagnosed in the early postinjury period persists after a full year of recovery, said Gianluca Aimaretti, M.D., of the University of Turin (Italy).

Dr. Aimaretti followed 47 TBI patients for 1 year, testing their pituitary function at 3 months and 12 months post injury. The patients' average age was 37 years; 33 patients were male.

At the 3-month evaluation, some degree of hypopituitarism was present in 40.4% of the patients, including 8.5% with total dysfunction, 6.3% with multiple deficits, and 25.6% with isolated deficits.

At 12 months, only 27.6% showed some degree of hypopituitarism, but all of the patients with early total hypopituitarism maintained that diagnosis. Also, about 4% of the patients whose pituitary function was normal at 3 months had developed isolated deficits (either secondary adrenal or secondary gonadal insufficiency).

NEW ORLEANS – A head injury can cause immediate hypopituitarism that may last for up to 12 months and set the stage for new-onset pituitary deficiencies during that time, researchers said at the annual meeting of the Endocrine Society.

Neuroendocrine abnormalities are common in the acute phase of a traumatic brain injury (TBI), said Amar Agha, M.D., of Beaumont Hospital, Dublin, Ireland. Dr. Agha tested pituitary function in 50 TBI patients and 31 age-matched healthy controls and found that almost all patients had some form of pituitary dysfunction in the first 2 weeks after a mild or moderate brain injury.

All subjects had a glucagon stimulation test. For TBI patients, the test was performed within 12 days of the injury. Of the injured patients, 16% had subnormal peak cortisol responses and 18% had subnormal growth hormone responses; these findings were unrelated to age, body mass index, initial Glasgow Coma Score (GCS), or levels of insulinlike growth factor I.

A gonadotropin deficiency unrelated to the presence of hyperprolactinemia was seen in 80% of the injured patients. In males, low serum testosterone concentrations were associated with low (more severe) GCS scores.

Hyperprolactinemia was present in 52% of the patients. High serum prolactin levels were associated with low GCS scores. Cranial diabetes insipidus was present in 26% of the patients, and 14% had inappropriate antidiuretic hormone secretion.

“Recognition of post-head injury hypopituitarism is important, as undiagnosed hormone deficiencies may have serious consequences,” Dr. Agha said. “Appropriate and timely hormone replacement in affected patients may accelerate recovery and improve prognosis.”

Whether these abnormalities are permanent remains unclear, Dr. Agha said. But even though some pituitary dysfunction resulting from traumatic brain injury is transient, total hypopituitarism diagnosed in the early postinjury period persists after a full year of recovery, said Gianluca Aimaretti, M.D., of the University of Turin (Italy).

Dr. Aimaretti followed 47 TBI patients for 1 year, testing their pituitary function at 3 months and 12 months post injury. The patients' average age was 37 years; 33 patients were male.

At the 3-month evaluation, some degree of hypopituitarism was present in 40.4% of the patients, including 8.5% with total dysfunction, 6.3% with multiple deficits, and 25.6% with isolated deficits.

At 12 months, only 27.6% showed some degree of hypopituitarism, but all of the patients with early total hypopituitarism maintained that diagnosis. Also, about 4% of the patients whose pituitary function was normal at 3 months had developed isolated deficits (either secondary adrenal or secondary gonadal insufficiency).

NEW ORLEANS – A head injury can cause immediate hypopituitarism that may last for up to 12 months and set the stage for new-onset pituitary deficiencies during that time, researchers said at the annual meeting of the Endocrine Society.

Neuroendocrine abnormalities are common in the acute phase of a traumatic brain injury (TBI), said Amar Agha, M.D., of Beaumont Hospital, Dublin, Ireland. Dr. Agha tested pituitary function in 50 TBI patients and 31 age-matched healthy controls and found that almost all patients had some form of pituitary dysfunction in the first 2 weeks after a mild or moderate brain injury.

All subjects had a glucagon stimulation test. For TBI patients, the test was performed within 12 days of the injury. Of the injured patients, 16% had subnormal peak cortisol responses and 18% had subnormal growth hormone responses; these findings were unrelated to age, body mass index, initial Glasgow Coma Score (GCS), or levels of insulinlike growth factor I.

A gonadotropin deficiency unrelated to the presence of hyperprolactinemia was seen in 80% of the injured patients. In males, low serum testosterone concentrations were associated with low (more severe) GCS scores.

Hyperprolactinemia was present in 52% of the patients. High serum prolactin levels were associated with low GCS scores. Cranial diabetes insipidus was present in 26% of the patients, and 14% had inappropriate antidiuretic hormone secretion.

“Recognition of post-head injury hypopituitarism is important, as undiagnosed hormone deficiencies may have serious consequences,” Dr. Agha said. “Appropriate and timely hormone replacement in affected patients may accelerate recovery and improve prognosis.”

Whether these abnormalities are permanent remains unclear, Dr. Agha said. But even though some pituitary dysfunction resulting from traumatic brain injury is transient, total hypopituitarism diagnosed in the early postinjury period persists after a full year of recovery, said Gianluca Aimaretti, M.D., of the University of Turin (Italy).

Dr. Aimaretti followed 47 TBI patients for 1 year, testing their pituitary function at 3 months and 12 months post injury. The patients' average age was 37 years; 33 patients were male.

At the 3-month evaluation, some degree of hypopituitarism was present in 40.4% of the patients, including 8.5% with total dysfunction, 6.3% with multiple deficits, and 25.6% with isolated deficits.

At 12 months, only 27.6% showed some degree of hypopituitarism, but all of the patients with early total hypopituitarism maintained that diagnosis. Also, about 4% of the patients whose pituitary function was normal at 3 months had developed isolated deficits (either secondary adrenal or secondary gonadal insufficiency).

NEW ORLEANS – The long-term social outcome for children with symptomatic generalized epilepsy is usually disappointing, with only 6% having normal intelligence and becoming seizure-free off medication and financially and socially independent.

“Twenty years after the onset of symptomatic generalized epilepsy, the outcome is usually death or complete dependence,” Carol Camfield, M.D., said at the annual meeting of the American Epilepsy Society. “Only a tiny fraction of these children are seizure-free and independent.”

Dr. Camfield of Dalhousie University, Halifax, Nova Scotia, examined outcomes for the 75 children with symptomatic generalized epilepsy (SGE) who were included in the Nova Scotia Childhood Epilepsy Cohort. The cohort includes 692 children diagnosed with epilepsy from 1977 to 1985. The outcomes assessment took place in 2003.

About 11% of the cohort had SGE. Of these 75 children, 45 (60%) developed seizures before 1 year of age. Undefined SGE was present in 28 (37%), 32 (43%) had West's syndrome, 4 (5%) had Lennox-Gastaut syndrome, and 9 (12%) had myoclonic astatic epilepsy. One child had Dravet's syndrome, and one child had partial complex seizures.

By the end of the follow-up period, 25% of the group (19) had died. The mean age at death was 11.6 years; the mean duration of epilepsy was 10.5 years. Of the 56 children who survived, the mean follow-up was more than 19 years.

Of the cohort of 75 patients, 25% were in remission off antiepileptic drugs, 5% were in remission on antiepileptic drugs, 8% were having seizures on antiepileptic drugs, and 37% were considered to have intractable epilepsy. Information was not available on the remaining survivors.

Social outcomes were almost universally poor for the survivors, who were an average of 23 years old at the time of assessment. Of the 46 survivors who were evaluated, almost half were unable to walk, three-quarters had mental handicap, and half had neurologic handicap. Only three were mentally and neurologically normal.

More than half of the group was living with a parent or guardian, and one-third lived in a group home or institution. Only three individuals were living independently, although another five were judged capable of independent living by their caretakers. Of the 46, 41 (89%) were completely financially dependent on their parents or the government.

Functional literacy–reading at about a fifth-grade level–had been achieved by one-quarter of the group. Another 18 (39%) had safety literacy; they could interpret an exit or stop sign and find appropriate bathrooms by looking at the picture on the door.

A good outcome (the ability to live independently) was seen in 8 (17%) of the group. A fair outcome (not capable of independent living, but not needing total care) occurred in 10 (22%). A bad outcome (requiring assistance with all activities of daily living) occurred in 28 (61%).

Almost all of the group (94%) were considered by their caregiver to have satisfactory overall health. Problematic sexual behavior occurred in 6 (11%), 13 (29%) were judged aggressive, and 10 (22%) were socially isolated. Some of the group had more than one problematic behavior.

NEW ORLEANS – The long-term social outcome for children with symptomatic generalized epilepsy is usually disappointing, with only 6% having normal intelligence and becoming seizure-free off medication and financially and socially independent.

“Twenty years after the onset of symptomatic generalized epilepsy, the outcome is usually death or complete dependence,” Carol Camfield, M.D., said at the annual meeting of the American Epilepsy Society. “Only a tiny fraction of these children are seizure-free and independent.”

Dr. Camfield of Dalhousie University, Halifax, Nova Scotia, examined outcomes for the 75 children with symptomatic generalized epilepsy (SGE) who were included in the Nova Scotia Childhood Epilepsy Cohort. The cohort includes 692 children diagnosed with epilepsy from 1977 to 1985. The outcomes assessment took place in 2003.

About 11% of the cohort had SGE. Of these 75 children, 45 (60%) developed seizures before 1 year of age. Undefined SGE was present in 28 (37%), 32 (43%) had West's syndrome, 4 (5%) had Lennox-Gastaut syndrome, and 9 (12%) had myoclonic astatic epilepsy. One child had Dravet's syndrome, and one child had partial complex seizures.

By the end of the follow-up period, 25% of the group (19) had died. The mean age at death was 11.6 years; the mean duration of epilepsy was 10.5 years. Of the 56 children who survived, the mean follow-up was more than 19 years.

Of the cohort of 75 patients, 25% were in remission off antiepileptic drugs, 5% were in remission on antiepileptic drugs, 8% were having seizures on antiepileptic drugs, and 37% were considered to have intractable epilepsy. Information was not available on the remaining survivors.

Social outcomes were almost universally poor for the survivors, who were an average of 23 years old at the time of assessment. Of the 46 survivors who were evaluated, almost half were unable to walk, three-quarters had mental handicap, and half had neurologic handicap. Only three were mentally and neurologically normal.

More than half of the group was living with a parent or guardian, and one-third lived in a group home or institution. Only three individuals were living independently, although another five were judged capable of independent living by their caretakers. Of the 46, 41 (89%) were completely financially dependent on their parents or the government.

Functional literacy–reading at about a fifth-grade level–had been achieved by one-quarter of the group. Another 18 (39%) had safety literacy; they could interpret an exit or stop sign and find appropriate bathrooms by looking at the picture on the door.

A good outcome (the ability to live independently) was seen in 8 (17%) of the group. A fair outcome (not capable of independent living, but not needing total care) occurred in 10 (22%). A bad outcome (requiring assistance with all activities of daily living) occurred in 28 (61%).

Almost all of the group (94%) were considered by their caregiver to have satisfactory overall health. Problematic sexual behavior occurred in 6 (11%), 13 (29%) were judged aggressive, and 10 (22%) were socially isolated. Some of the group had more than one problematic behavior.

NEW ORLEANS – The long-term social outcome for children with symptomatic generalized epilepsy is usually disappointing, with only 6% having normal intelligence and becoming seizure-free off medication and financially and socially independent.

“Twenty years after the onset of symptomatic generalized epilepsy, the outcome is usually death or complete dependence,” Carol Camfield, M.D., said at the annual meeting of the American Epilepsy Society. “Only a tiny fraction of these children are seizure-free and independent.”

Dr. Camfield of Dalhousie University, Halifax, Nova Scotia, examined outcomes for the 75 children with symptomatic generalized epilepsy (SGE) who were included in the Nova Scotia Childhood Epilepsy Cohort. The cohort includes 692 children diagnosed with epilepsy from 1977 to 1985. The outcomes assessment took place in 2003.

About 11% of the cohort had SGE. Of these 75 children, 45 (60%) developed seizures before 1 year of age. Undefined SGE was present in 28 (37%), 32 (43%) had West's syndrome, 4 (5%) had Lennox-Gastaut syndrome, and 9 (12%) had myoclonic astatic epilepsy. One child had Dravet's syndrome, and one child had partial complex seizures.

By the end of the follow-up period, 25% of the group (19) had died. The mean age at death was 11.6 years; the mean duration of epilepsy was 10.5 years. Of the 56 children who survived, the mean follow-up was more than 19 years.

Of the cohort of 75 patients, 25% were in remission off antiepileptic drugs, 5% were in remission on antiepileptic drugs, 8% were having seizures on antiepileptic drugs, and 37% were considered to have intractable epilepsy. Information was not available on the remaining survivors.

Social outcomes were almost universally poor for the survivors, who were an average of 23 years old at the time of assessment. Of the 46 survivors who were evaluated, almost half were unable to walk, three-quarters had mental handicap, and half had neurologic handicap. Only three were mentally and neurologically normal.

More than half of the group was living with a parent or guardian, and one-third lived in a group home or institution. Only three individuals were living independently, although another five were judged capable of independent living by their caretakers. Of the 46, 41 (89%) were completely financially dependent on their parents or the government.

Functional literacy–reading at about a fifth-grade level–had been achieved by one-quarter of the group. Another 18 (39%) had safety literacy; they could interpret an exit or stop sign and find appropriate bathrooms by looking at the picture on the door.

A good outcome (the ability to live independently) was seen in 8 (17%) of the group. A fair outcome (not capable of independent living, but not needing total care) occurred in 10 (22%). A bad outcome (requiring assistance with all activities of daily living) occurred in 28 (61%).

Almost all of the group (94%) were considered by their caregiver to have satisfactory overall health. Problematic sexual behavior occurred in 6 (11%), 13 (29%) were judged aggressive, and 10 (22%) were socially isolated. Some of the group had more than one problematic behavior.

STOCKHOLM – Atypical antipsychotics appear to be a good choice for treating children with bipolar disorder, and they also show promise for treating psychotic symptoms in these patients, Joseph Biederman, M.D., reported in a poster session at the annual congress of the European College of Neuropsychopharmacology.

Although rare, childhood bipolar disorder is among the most severely disabling pediatric mental disorders. Because this disorder has been assumed to be extremely rare, no standard treatment options exist. “Children with bipolar disorder are frequently treated with many medications with unclear efficacy and inadequate safety data,” said Dr. Biederman of Harvard Medical School, Boston.

Dr. Biederman undertook an 8-week randomized open-label study of the efficacy of olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel), and ziprasidone (Geodon) in children with bipolar disorder. The 103 patients were aged 6-17 years. At baseline, they were all markedly impaired according to the Young Mania Rating Scale (YMRS). By the study's end, the mean dosages were 7.5 mg/day for olanzapine, 250 mg/day for quetiapine, 1.4 mg/day for risperidone, and 56 mg/day for ziprasidone.

After 8 weeks, there were no statistically significant differences between the groups in response. At least 50% of the children in each group showed a marked response (either a Clinical Global Impression rating of much or very much improved or a 30% reduction in symptoms).

Half the children in both the olanzapine and ziprasidone groups experienced a robust response to the therapy (Clinical Global Impression rating of much or very much improved and a 30% reduction in YMRS scores). The rate of robust response was higher in the quetiapine (55%) and risperidone groups (75%).

Weight gain over the study was substantial but varied significantly across study groups. Olanzapine was associated with an increase (4.9 kg) that was significantly greater than the weight gain for risperidone (2.1 kg), quetiapine (1.9 kg), and ziprasidone (0.8 kg).

Some of these medications also appear effective in decreasing psychotic symptoms in pediatric bipolar patients, Dr. Biederman reported in a separate poster. In a similarly designed 8-week open-label trial, 110 children with bipolar disorder were randomized to risperidone, quetiapine, or olanzapine. The children were aged 6-17 years, and 26% had a history of psychosis.

By the trial's end, there was a significant reduction of 10 points on the Brief Psychiatric Rating Scale that did not differ between groups. Differences did emerge in changes measured by the YMRS. All the drugs were associated with significant improvements in symptoms of mania, but only risperidone was associated with a significant improvement in symptoms of psychosis.

Side effects were mild and included increased appetite (29%), gastrointestinal discomfort (20%), headache (18%), sedation (18%), and myalgia (10%). Weight gain was highest in the olanzapine group (mean 4.7 kg). Those in the risperidone group gained a mean of 1.97 kg, and those in the quetiapine group gained a mean of 1.4 kg.

There was a statistically significant increase in prolactin levels in subjects treated with risperidone (33.9 ng/mL) and olanzapine (5.1 ng/mL), but not quetiapine (0.5 ng/mL), Dr. Biederman said.

STOCKHOLM – Atypical antipsychotics appear to be a good choice for treating children with bipolar disorder, and they also show promise for treating psychotic symptoms in these patients, Joseph Biederman, M.D., reported in a poster session at the annual congress of the European College of Neuropsychopharmacology.

Although rare, childhood bipolar disorder is among the most severely disabling pediatric mental disorders. Because this disorder has been assumed to be extremely rare, no standard treatment options exist. “Children with bipolar disorder are frequently treated with many medications with unclear efficacy and inadequate safety data,” said Dr. Biederman of Harvard Medical School, Boston.

Dr. Biederman undertook an 8-week randomized open-label study of the efficacy of olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel), and ziprasidone (Geodon) in children with bipolar disorder. The 103 patients were aged 6-17 years. At baseline, they were all markedly impaired according to the Young Mania Rating Scale (YMRS). By the study's end, the mean dosages were 7.5 mg/day for olanzapine, 250 mg/day for quetiapine, 1.4 mg/day for risperidone, and 56 mg/day for ziprasidone.

After 8 weeks, there were no statistically significant differences between the groups in response. At least 50% of the children in each group showed a marked response (either a Clinical Global Impression rating of much or very much improved or a 30% reduction in symptoms).

Half the children in both the olanzapine and ziprasidone groups experienced a robust response to the therapy (Clinical Global Impression rating of much or very much improved and a 30% reduction in YMRS scores). The rate of robust response was higher in the quetiapine (55%) and risperidone groups (75%).

Weight gain over the study was substantial but varied significantly across study groups. Olanzapine was associated with an increase (4.9 kg) that was significantly greater than the weight gain for risperidone (2.1 kg), quetiapine (1.9 kg), and ziprasidone (0.8 kg).

Some of these medications also appear effective in decreasing psychotic symptoms in pediatric bipolar patients, Dr. Biederman reported in a separate poster. In a similarly designed 8-week open-label trial, 110 children with bipolar disorder were randomized to risperidone, quetiapine, or olanzapine. The children were aged 6-17 years, and 26% had a history of psychosis.

By the trial's end, there was a significant reduction of 10 points on the Brief Psychiatric Rating Scale that did not differ between groups. Differences did emerge in changes measured by the YMRS. All the drugs were associated with significant improvements in symptoms of mania, but only risperidone was associated with a significant improvement in symptoms of psychosis.

Side effects were mild and included increased appetite (29%), gastrointestinal discomfort (20%), headache (18%), sedation (18%), and myalgia (10%). Weight gain was highest in the olanzapine group (mean 4.7 kg). Those in the risperidone group gained a mean of 1.97 kg, and those in the quetiapine group gained a mean of 1.4 kg.

There was a statistically significant increase in prolactin levels in subjects treated with risperidone (33.9 ng/mL) and olanzapine (5.1 ng/mL), but not quetiapine (0.5 ng/mL), Dr. Biederman said.

STOCKHOLM – Atypical antipsychotics appear to be a good choice for treating children with bipolar disorder, and they also show promise for treating psychotic symptoms in these patients, Joseph Biederman, M.D., reported in a poster session at the annual congress of the European College of Neuropsychopharmacology.

Although rare, childhood bipolar disorder is among the most severely disabling pediatric mental disorders. Because this disorder has been assumed to be extremely rare, no standard treatment options exist. “Children with bipolar disorder are frequently treated with many medications with unclear efficacy and inadequate safety data,” said Dr. Biederman of Harvard Medical School, Boston.

Dr. Biederman undertook an 8-week randomized open-label study of the efficacy of olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel), and ziprasidone (Geodon) in children with bipolar disorder. The 103 patients were aged 6-17 years. At baseline, they were all markedly impaired according to the Young Mania Rating Scale (YMRS). By the study's end, the mean dosages were 7.5 mg/day for olanzapine, 250 mg/day for quetiapine, 1.4 mg/day for risperidone, and 56 mg/day for ziprasidone.

After 8 weeks, there were no statistically significant differences between the groups in response. At least 50% of the children in each group showed a marked response (either a Clinical Global Impression rating of much or very much improved or a 30% reduction in symptoms).

Half the children in both the olanzapine and ziprasidone groups experienced a robust response to the therapy (Clinical Global Impression rating of much or very much improved and a 30% reduction in YMRS scores). The rate of robust response was higher in the quetiapine (55%) and risperidone groups (75%).

Weight gain over the study was substantial but varied significantly across study groups. Olanzapine was associated with an increase (4.9 kg) that was significantly greater than the weight gain for risperidone (2.1 kg), quetiapine (1.9 kg), and ziprasidone (0.8 kg).

Some of these medications also appear effective in decreasing psychotic symptoms in pediatric bipolar patients, Dr. Biederman reported in a separate poster. In a similarly designed 8-week open-label trial, 110 children with bipolar disorder were randomized to risperidone, quetiapine, or olanzapine. The children were aged 6-17 years, and 26% had a history of psychosis.

By the trial's end, there was a significant reduction of 10 points on the Brief Psychiatric Rating Scale that did not differ between groups. Differences did emerge in changes measured by the YMRS. All the drugs were associated with significant improvements in symptoms of mania, but only risperidone was associated with a significant improvement in symptoms of psychosis.

Side effects were mild and included increased appetite (29%), gastrointestinal discomfort (20%), headache (18%), sedation (18%), and myalgia (10%). Weight gain was highest in the olanzapine group (mean 4.7 kg). Those in the risperidone group gained a mean of 1.97 kg, and those in the quetiapine group gained a mean of 1.4 kg.

There was a statistically significant increase in prolactin levels in subjects treated with risperidone (33.9 ng/mL) and olanzapine (5.1 ng/mL), but not quetiapine (0.5 ng/mL), Dr. Biederman said.