Duloxetine Effective for Fibromyalgia in Women

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VANCOUVER, B.C. — Duloxetine is a safe and effective treatment for fibromyalgia symptoms in both depressed and nondepressed women, Lesley Arnold, M.D., reported at the annual meeting of the American Psychosomatic Society.

Duloxetine (Cymbalta) is approved for the treatment of both major depression and diabetic neuropathic pain. The drug's efficacy in treating both pain and depression—which often co-occur in fibromyalgia—is probably due to its dual action as a selective serotonin and norepinephrine reuptake inhibitor, said Dr. Arnold, a psychiatrist who is director of women's health research at the University of Cincinnati.

In one of two 12-week studies funded by Lilly Research Laboratories, a total of 354 adult women who met the American College of Rheumatology's criteria for primary fibromyalgia were randomized to receive 60 mg of duloxetine once a day (118), 60 mg twice daily (116), or placebo (120).

Significant differences in the Brief Pain Inventory (BPI) average 24-hour pain score and the Fibromyalgia Impact Questionnaire (FIQ) were seen within 1 week in both the 60 mg/day and 120 mg/day duloxetine groups compared with placebo, with no significant difference between the two dosages.

In the low- and high-dose groups, 41% of patients experienced a 50% reduction in overall pain, compared with 23% of patients on placebo, Dr. Arnold reported.

Significant improvements over placebo were also seen in the FIQ total, pain, fatigue, and restfulness upon awakening scores; in the mean tender point threshold and number of tender points; in the Clinical Global Impression (CGI) and Patient Global Impression of Improvement (PGI) scores; in other BPI subscale measures of pain severity and interference; and in several quality of life and functional measures.

This study replicated several findings from a previously published trial of 207 fibromyalgia patients that included a small number of men. Dr. Arnold presented the findings of both trials together in a poster at the meeting.

In the earlier study, 104 patients (89% women) were randomized to 120 mg/day of duloxetine, and 103 (89% women) to placebo. Duloxetine patients improved significantly more than did placebo-treated patients on the FIQ total score, but not significantly more on the FIQ pain score (Arthritis Rheum. 2004;50:2974-84).

Duloxetine-treated patients also had significant reductions compared with placebo-treated patients in BPI scores for average pain severity and interference from pain, number of tender points, and FIQ stiffness, as well as several other fibro-myalgia-specific and quality of life measures. The differences were only significant for women, but the number of men was quite small, Dr. Arnold noted.

Major depression was present in approximately 40% of the subjects in the earlier single-dose study and in about one-fourth of the subjects in the two-dose study. In both studies, there were no differences between depressed and nondepressed patients in duloxetine efficacy in alleviating pain and fibromyalgia symptoms, suggesting that these effects are not simply due to an improvement in mood, she noted.

In the first study, duloxetine was significantly more likely than placebo to be associated with side effects including constipation, dry mouth, insomnia, and a small mean increase in heart rate. These were typically mild to moderate in severity. Also in that study, anxiety was reported significantly less often with duloxetine than with placebo.

In the more recent study, nausea, dry mouth, constipation, diarrhea, somnolence, decreased appetite and weight, and a small mean increase in systolic and diastolic blood pressure were among the side effects reported more frequently by duloxetine-treated patients than by those on placebo. These side effects were also generally mild to moderate in severity. In all, the drug was safely administered and well tolerated, Dr. Arnold said.

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VANCOUVER, B.C. — Duloxetine is a safe and effective treatment for fibromyalgia symptoms in both depressed and nondepressed women, Lesley Arnold, M.D., reported at the annual meeting of the American Psychosomatic Society.

Duloxetine (Cymbalta) is approved for the treatment of both major depression and diabetic neuropathic pain. The drug's efficacy in treating both pain and depression—which often co-occur in fibromyalgia—is probably due to its dual action as a selective serotonin and norepinephrine reuptake inhibitor, said Dr. Arnold, a psychiatrist who is director of women's health research at the University of Cincinnati.

In one of two 12-week studies funded by Lilly Research Laboratories, a total of 354 adult women who met the American College of Rheumatology's criteria for primary fibromyalgia were randomized to receive 60 mg of duloxetine once a day (118), 60 mg twice daily (116), or placebo (120).

Significant differences in the Brief Pain Inventory (BPI) average 24-hour pain score and the Fibromyalgia Impact Questionnaire (FIQ) were seen within 1 week in both the 60 mg/day and 120 mg/day duloxetine groups compared with placebo, with no significant difference between the two dosages.

In the low- and high-dose groups, 41% of patients experienced a 50% reduction in overall pain, compared with 23% of patients on placebo, Dr. Arnold reported.

Significant improvements over placebo were also seen in the FIQ total, pain, fatigue, and restfulness upon awakening scores; in the mean tender point threshold and number of tender points; in the Clinical Global Impression (CGI) and Patient Global Impression of Improvement (PGI) scores; in other BPI subscale measures of pain severity and interference; and in several quality of life and functional measures.

This study replicated several findings from a previously published trial of 207 fibromyalgia patients that included a small number of men. Dr. Arnold presented the findings of both trials together in a poster at the meeting.

In the earlier study, 104 patients (89% women) were randomized to 120 mg/day of duloxetine, and 103 (89% women) to placebo. Duloxetine patients improved significantly more than did placebo-treated patients on the FIQ total score, but not significantly more on the FIQ pain score (Arthritis Rheum. 2004;50:2974-84).

Duloxetine-treated patients also had significant reductions compared with placebo-treated patients in BPI scores for average pain severity and interference from pain, number of tender points, and FIQ stiffness, as well as several other fibro-myalgia-specific and quality of life measures. The differences were only significant for women, but the number of men was quite small, Dr. Arnold noted.

Major depression was present in approximately 40% of the subjects in the earlier single-dose study and in about one-fourth of the subjects in the two-dose study. In both studies, there were no differences between depressed and nondepressed patients in duloxetine efficacy in alleviating pain and fibromyalgia symptoms, suggesting that these effects are not simply due to an improvement in mood, she noted.

In the first study, duloxetine was significantly more likely than placebo to be associated with side effects including constipation, dry mouth, insomnia, and a small mean increase in heart rate. These were typically mild to moderate in severity. Also in that study, anxiety was reported significantly less often with duloxetine than with placebo.

In the more recent study, nausea, dry mouth, constipation, diarrhea, somnolence, decreased appetite and weight, and a small mean increase in systolic and diastolic blood pressure were among the side effects reported more frequently by duloxetine-treated patients than by those on placebo. These side effects were also generally mild to moderate in severity. In all, the drug was safely administered and well tolerated, Dr. Arnold said.

VANCOUVER, B.C. — Duloxetine is a safe and effective treatment for fibromyalgia symptoms in both depressed and nondepressed women, Lesley Arnold, M.D., reported at the annual meeting of the American Psychosomatic Society.

Duloxetine (Cymbalta) is approved for the treatment of both major depression and diabetic neuropathic pain. The drug's efficacy in treating both pain and depression—which often co-occur in fibromyalgia—is probably due to its dual action as a selective serotonin and norepinephrine reuptake inhibitor, said Dr. Arnold, a psychiatrist who is director of women's health research at the University of Cincinnati.

In one of two 12-week studies funded by Lilly Research Laboratories, a total of 354 adult women who met the American College of Rheumatology's criteria for primary fibromyalgia were randomized to receive 60 mg of duloxetine once a day (118), 60 mg twice daily (116), or placebo (120).

Significant differences in the Brief Pain Inventory (BPI) average 24-hour pain score and the Fibromyalgia Impact Questionnaire (FIQ) were seen within 1 week in both the 60 mg/day and 120 mg/day duloxetine groups compared with placebo, with no significant difference between the two dosages.

In the low- and high-dose groups, 41% of patients experienced a 50% reduction in overall pain, compared with 23% of patients on placebo, Dr. Arnold reported.

Significant improvements over placebo were also seen in the FIQ total, pain, fatigue, and restfulness upon awakening scores; in the mean tender point threshold and number of tender points; in the Clinical Global Impression (CGI) and Patient Global Impression of Improvement (PGI) scores; in other BPI subscale measures of pain severity and interference; and in several quality of life and functional measures.

This study replicated several findings from a previously published trial of 207 fibromyalgia patients that included a small number of men. Dr. Arnold presented the findings of both trials together in a poster at the meeting.

In the earlier study, 104 patients (89% women) were randomized to 120 mg/day of duloxetine, and 103 (89% women) to placebo. Duloxetine patients improved significantly more than did placebo-treated patients on the FIQ total score, but not significantly more on the FIQ pain score (Arthritis Rheum. 2004;50:2974-84).

Duloxetine-treated patients also had significant reductions compared with placebo-treated patients in BPI scores for average pain severity and interference from pain, number of tender points, and FIQ stiffness, as well as several other fibro-myalgia-specific and quality of life measures. The differences were only significant for women, but the number of men was quite small, Dr. Arnold noted.

Major depression was present in approximately 40% of the subjects in the earlier single-dose study and in about one-fourth of the subjects in the two-dose study. In both studies, there were no differences between depressed and nondepressed patients in duloxetine efficacy in alleviating pain and fibromyalgia symptoms, suggesting that these effects are not simply due to an improvement in mood, she noted.

In the first study, duloxetine was significantly more likely than placebo to be associated with side effects including constipation, dry mouth, insomnia, and a small mean increase in heart rate. These were typically mild to moderate in severity. Also in that study, anxiety was reported significantly less often with duloxetine than with placebo.

In the more recent study, nausea, dry mouth, constipation, diarrhea, somnolence, decreased appetite and weight, and a small mean increase in systolic and diastolic blood pressure were among the side effects reported more frequently by duloxetine-treated patients than by those on placebo. These side effects were also generally mild to moderate in severity. In all, the drug was safely administered and well tolerated, Dr. Arnold said.

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Wide Variation Seen in Hepatitis A Vaccination

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Immunization rates for hepatitis A in children aged 24-35 months vary widely across areas and populations in the United States, the Centers for Disease Control and Prevention said.

In 1999, the CDC recommended routine immunization against hepatitis A for children residing in 11 states in which the average annual incidence during 1987-1997 was at least 20 per 100,000 population, or twice the national average. Those states are Alaska, Arizona, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dakota, Utah, and Washington.

They also advised that hepatitis A vaccination be considered in another six states (Arkansas, Colorado, Missouri, Montana, Texas, and Wyoming) where the average incidence was 10-20/100,000 population (MMWR 2005; 54:141-5).

Later this year, the CDC's Advisory Committee on Immunization Practices is expected to discuss broadening these recommendations for the two currently-licensed hepatitis A vaccines, GlaxoSmithKline's Havrix and Merck's VAQTA. Both are inactivated vaccines, given in two doses at least 6 months apart to children aged 24 months and above.

In the first national analysis of hepatitis A vaccination coverage among children, data were collected from provider immunization records for 13,731 children during 2003. In the 11 states in which routine hepatitis A vaccination is recommended, the proportion of children aged 24-35 months who had received at least one dose of vaccine varied from a low of 6.4% (South Dakota) to a high of 72.7% (Alaska).

The overall rate, 50.9%, is below that of other vaccines recommended for routine use in children, the CDC said.

In the six states where hepatitis A vaccination should be considered, 25.0% of children aged 24-35 months had been vaccinated, compared with just 1.4% in the other 33 states with no recommendation. Only two states (Alaska and Arizona) and four urban areas (Maricopa County, Ariz., Los Angeles County, Calif., and Bexar and El Paso Counties, Tex.) had coverage estimates over 60%.

The wide variation in coverage is likely due to targeted programs in some areas. For example, vaccination requirements in Texas border counties for all children attending day care programs probably account for the higher coverage in El Paso County (71%), compared with the rest of the state, the CDC said.

Within the areas where routine hepatitis A vaccine is recommended or should be considered, Hispanic and Native American/Alaska Native children had higher coverage rates that either non-Hispanic white or black children. This finding may be related to greater recognition of the disease among groups that have been identified as high risk.

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Immunization rates for hepatitis A in children aged 24-35 months vary widely across areas and populations in the United States, the Centers for Disease Control and Prevention said.

In 1999, the CDC recommended routine immunization against hepatitis A for children residing in 11 states in which the average annual incidence during 1987-1997 was at least 20 per 100,000 population, or twice the national average. Those states are Alaska, Arizona, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dakota, Utah, and Washington.

They also advised that hepatitis A vaccination be considered in another six states (Arkansas, Colorado, Missouri, Montana, Texas, and Wyoming) where the average incidence was 10-20/100,000 population (MMWR 2005; 54:141-5).

Later this year, the CDC's Advisory Committee on Immunization Practices is expected to discuss broadening these recommendations for the two currently-licensed hepatitis A vaccines, GlaxoSmithKline's Havrix and Merck's VAQTA. Both are inactivated vaccines, given in two doses at least 6 months apart to children aged 24 months and above.

In the first national analysis of hepatitis A vaccination coverage among children, data were collected from provider immunization records for 13,731 children during 2003. In the 11 states in which routine hepatitis A vaccination is recommended, the proportion of children aged 24-35 months who had received at least one dose of vaccine varied from a low of 6.4% (South Dakota) to a high of 72.7% (Alaska).

The overall rate, 50.9%, is below that of other vaccines recommended for routine use in children, the CDC said.

In the six states where hepatitis A vaccination should be considered, 25.0% of children aged 24-35 months had been vaccinated, compared with just 1.4% in the other 33 states with no recommendation. Only two states (Alaska and Arizona) and four urban areas (Maricopa County, Ariz., Los Angeles County, Calif., and Bexar and El Paso Counties, Tex.) had coverage estimates over 60%.

The wide variation in coverage is likely due to targeted programs in some areas. For example, vaccination requirements in Texas border counties for all children attending day care programs probably account for the higher coverage in El Paso County (71%), compared with the rest of the state, the CDC said.

Within the areas where routine hepatitis A vaccine is recommended or should be considered, Hispanic and Native American/Alaska Native children had higher coverage rates that either non-Hispanic white or black children. This finding may be related to greater recognition of the disease among groups that have been identified as high risk.

Immunization rates for hepatitis A in children aged 24-35 months vary widely across areas and populations in the United States, the Centers for Disease Control and Prevention said.

In 1999, the CDC recommended routine immunization against hepatitis A for children residing in 11 states in which the average annual incidence during 1987-1997 was at least 20 per 100,000 population, or twice the national average. Those states are Alaska, Arizona, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dakota, Utah, and Washington.

They also advised that hepatitis A vaccination be considered in another six states (Arkansas, Colorado, Missouri, Montana, Texas, and Wyoming) where the average incidence was 10-20/100,000 population (MMWR 2005; 54:141-5).

Later this year, the CDC's Advisory Committee on Immunization Practices is expected to discuss broadening these recommendations for the two currently-licensed hepatitis A vaccines, GlaxoSmithKline's Havrix and Merck's VAQTA. Both are inactivated vaccines, given in two doses at least 6 months apart to children aged 24 months and above.

In the first national analysis of hepatitis A vaccination coverage among children, data were collected from provider immunization records for 13,731 children during 2003. In the 11 states in which routine hepatitis A vaccination is recommended, the proportion of children aged 24-35 months who had received at least one dose of vaccine varied from a low of 6.4% (South Dakota) to a high of 72.7% (Alaska).

The overall rate, 50.9%, is below that of other vaccines recommended for routine use in children, the CDC said.

In the six states where hepatitis A vaccination should be considered, 25.0% of children aged 24-35 months had been vaccinated, compared with just 1.4% in the other 33 states with no recommendation. Only two states (Alaska and Arizona) and four urban areas (Maricopa County, Ariz., Los Angeles County, Calif., and Bexar and El Paso Counties, Tex.) had coverage estimates over 60%.

The wide variation in coverage is likely due to targeted programs in some areas. For example, vaccination requirements in Texas border counties for all children attending day care programs probably account for the higher coverage in El Paso County (71%), compared with the rest of the state, the CDC said.

Within the areas where routine hepatitis A vaccine is recommended or should be considered, Hispanic and Native American/Alaska Native children had higher coverage rates that either non-Hispanic white or black children. This finding may be related to greater recognition of the disease among groups that have been identified as high risk.

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Duloxetine Confirmed Effective For Fibromyalgia in Women

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VANCOUVER, B.C. — Duloxetine is a safe and effective treatment for fibromyalgia symptoms in both depressed and nondepressed women, Lesley Arnold, M.D., reported at the annual meeting of the American Psychosomatic Society.

Duloxetine (Cymbalta) is approved for the treatment of both major depression and diabetic neuropathic pain. The drug's efficacy in treating both pain and depression—which often co-occur in fibromyalgia—is probably due to its dual action as a selective serotonin and norepinephrine reuptake inhibitor, said Dr. Arnold, a psychiatrist who is director of women's health research at the University of Cincinnati.

In one of two 12-week studies funded by Lilly Research Laboratories, a total of 354 adult women who met the American College of Rheumatology's criteria for primary fibromyalgia were randomized to receive 60 mg of duloxetine once a day (118), 60 mg twice daily (116), or placebo (120).

Significant differences in the Brief Pain Inventory (BPI) average 24-hour pain score and the Fibromyalgia Impact Questionnaire (FIQ) were seen within 1 week in both the 60-mg/day and 120-mg/day duloxetine groups compared with placebo, with no significant difference between the two dosages.

In the low- and high-dose groups, 41% of patients experienced a 50% reduction in overall pain, compared with 23% of patients on placebo, Dr. Arnold reported.

Significant improvements over placebo were also seen in the FIQ total, pain, fatigue, and restfulness upon awakening scores; in the mean tender point threshold and number of tender points; in the Clinical Global Impression (CGI) and Patient Global Impression of Improvement (PGI) scores; in other BPI subscale measures of pain severity and interference; and in several quality of life and functional measures.

This study replicated several findings from a previously-published trial of 207 fibromyalgia patients that included a small number of men. Dr. Arnold presented the findings of both trials together in a poster at the meeting.

In the earlier study, 104 patients (89% women) were randomized to 120 mg/day of duloxetine, and 103 (89% women) to placebo. Duloxetine patients improved significantly more than did placebo-treated patients on the FIQ total score, but not significantly more on the FIQ pain score (Arthritis Rheum. 2004;50:2974-84).

Duloxetine-treated patients also had significant reductions compared with placebo-treated patients in BPI scores for average pain severity and interference from pain, number of tender points, and FIQ stiffness, as well as several other fibromyalgia-specific and quality of life measures. The differences were only significant for women, but the number of men was quite small, Dr. Arnold noted.

Major depression was present in approximately 40% of the subjects in the earlier single-dose study and in about one-fourth of the subjects in the two-dose study. In both studies, there were no differences between depressed and nondepressed patients in duloxetine efficacy in alleviating pain and fibromyalgia symptoms, suggesting that these effects are not simply due to an improvement in mood, she noted.

In the first study, duloxetine was significantly more likely than placebo to be associated with side effects including constipation, dry mouth, insomnia, and a small mean increase in heart rate. These were typically mild to moderate in severity. Also in that study, anxiety was reported significantly less often with duloxetine than with placebo.

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VANCOUVER, B.C. — Duloxetine is a safe and effective treatment for fibromyalgia symptoms in both depressed and nondepressed women, Lesley Arnold, M.D., reported at the annual meeting of the American Psychosomatic Society.

Duloxetine (Cymbalta) is approved for the treatment of both major depression and diabetic neuropathic pain. The drug's efficacy in treating both pain and depression—which often co-occur in fibromyalgia—is probably due to its dual action as a selective serotonin and norepinephrine reuptake inhibitor, said Dr. Arnold, a psychiatrist who is director of women's health research at the University of Cincinnati.

In one of two 12-week studies funded by Lilly Research Laboratories, a total of 354 adult women who met the American College of Rheumatology's criteria for primary fibromyalgia were randomized to receive 60 mg of duloxetine once a day (118), 60 mg twice daily (116), or placebo (120).

Significant differences in the Brief Pain Inventory (BPI) average 24-hour pain score and the Fibromyalgia Impact Questionnaire (FIQ) were seen within 1 week in both the 60-mg/day and 120-mg/day duloxetine groups compared with placebo, with no significant difference between the two dosages.

In the low- and high-dose groups, 41% of patients experienced a 50% reduction in overall pain, compared with 23% of patients on placebo, Dr. Arnold reported.

Significant improvements over placebo were also seen in the FIQ total, pain, fatigue, and restfulness upon awakening scores; in the mean tender point threshold and number of tender points; in the Clinical Global Impression (CGI) and Patient Global Impression of Improvement (PGI) scores; in other BPI subscale measures of pain severity and interference; and in several quality of life and functional measures.

This study replicated several findings from a previously-published trial of 207 fibromyalgia patients that included a small number of men. Dr. Arnold presented the findings of both trials together in a poster at the meeting.

In the earlier study, 104 patients (89% women) were randomized to 120 mg/day of duloxetine, and 103 (89% women) to placebo. Duloxetine patients improved significantly more than did placebo-treated patients on the FIQ total score, but not significantly more on the FIQ pain score (Arthritis Rheum. 2004;50:2974-84).

Duloxetine-treated patients also had significant reductions compared with placebo-treated patients in BPI scores for average pain severity and interference from pain, number of tender points, and FIQ stiffness, as well as several other fibromyalgia-specific and quality of life measures. The differences were only significant for women, but the number of men was quite small, Dr. Arnold noted.

Major depression was present in approximately 40% of the subjects in the earlier single-dose study and in about one-fourth of the subjects in the two-dose study. In both studies, there were no differences between depressed and nondepressed patients in duloxetine efficacy in alleviating pain and fibromyalgia symptoms, suggesting that these effects are not simply due to an improvement in mood, she noted.

In the first study, duloxetine was significantly more likely than placebo to be associated with side effects including constipation, dry mouth, insomnia, and a small mean increase in heart rate. These were typically mild to moderate in severity. Also in that study, anxiety was reported significantly less often with duloxetine than with placebo.

VANCOUVER, B.C. — Duloxetine is a safe and effective treatment for fibromyalgia symptoms in both depressed and nondepressed women, Lesley Arnold, M.D., reported at the annual meeting of the American Psychosomatic Society.

Duloxetine (Cymbalta) is approved for the treatment of both major depression and diabetic neuropathic pain. The drug's efficacy in treating both pain and depression—which often co-occur in fibromyalgia—is probably due to its dual action as a selective serotonin and norepinephrine reuptake inhibitor, said Dr. Arnold, a psychiatrist who is director of women's health research at the University of Cincinnati.

In one of two 12-week studies funded by Lilly Research Laboratories, a total of 354 adult women who met the American College of Rheumatology's criteria for primary fibromyalgia were randomized to receive 60 mg of duloxetine once a day (118), 60 mg twice daily (116), or placebo (120).

Significant differences in the Brief Pain Inventory (BPI) average 24-hour pain score and the Fibromyalgia Impact Questionnaire (FIQ) were seen within 1 week in both the 60-mg/day and 120-mg/day duloxetine groups compared with placebo, with no significant difference between the two dosages.

In the low- and high-dose groups, 41% of patients experienced a 50% reduction in overall pain, compared with 23% of patients on placebo, Dr. Arnold reported.

Significant improvements over placebo were also seen in the FIQ total, pain, fatigue, and restfulness upon awakening scores; in the mean tender point threshold and number of tender points; in the Clinical Global Impression (CGI) and Patient Global Impression of Improvement (PGI) scores; in other BPI subscale measures of pain severity and interference; and in several quality of life and functional measures.

This study replicated several findings from a previously-published trial of 207 fibromyalgia patients that included a small number of men. Dr. Arnold presented the findings of both trials together in a poster at the meeting.

In the earlier study, 104 patients (89% women) were randomized to 120 mg/day of duloxetine, and 103 (89% women) to placebo. Duloxetine patients improved significantly more than did placebo-treated patients on the FIQ total score, but not significantly more on the FIQ pain score (Arthritis Rheum. 2004;50:2974-84).

Duloxetine-treated patients also had significant reductions compared with placebo-treated patients in BPI scores for average pain severity and interference from pain, number of tender points, and FIQ stiffness, as well as several other fibromyalgia-specific and quality of life measures. The differences were only significant for women, but the number of men was quite small, Dr. Arnold noted.

Major depression was present in approximately 40% of the subjects in the earlier single-dose study and in about one-fourth of the subjects in the two-dose study. In both studies, there were no differences between depressed and nondepressed patients in duloxetine efficacy in alleviating pain and fibromyalgia symptoms, suggesting that these effects are not simply due to an improvement in mood, she noted.

In the first study, duloxetine was significantly more likely than placebo to be associated with side effects including constipation, dry mouth, insomnia, and a small mean increase in heart rate. These were typically mild to moderate in severity. Also in that study, anxiety was reported significantly less often with duloxetine than with placebo.

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Yoga Alleviates Fibromyalgia-Related Pain, Fatigue

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VANCOUVER, B.C. — Yoga may be an effective adjunct to medical treatment for patients with fibromyalgia, Malinda L. Breda, Ph.D., reported at the annual meeting of the American Psychosomatic Society.

There are many reasons why yoga is an attractive treatment for fibromyalgia, which affects about 6 million Americans. Current therapies provide inadequate symptom relief, and a recent metaanalysis concluded that optimal treatment regimens should include nonpharmacologic interventions such as exercise (Ann. Behav. Med. 1999;21:180-91).

But although conventional exercise can alleviate symptoms for some fibromyalgia patients, it actually worsens them in others, said Dr. Breda, of the California School of Professional Psychology, San Diego.

Of 38 adults who met the 1990 American College of Rheumatology criteria for fibromyalgia, 19 were randomized to an experimental yoga group, and 19 controls were put on a waiting list. The yoga intervention consisted of 8 weeks of Classical Hatha Yoga, taught by a certified instructor who had experience with fibromyalgia patients.

The 90-minute sessions emphasized gentle poses and breath-work designed to match individual ability and were followed by relaxation/meditation exercises. Classes were conducted twice weekly, and subjects practiced at home with a video the other 5 days of each week. Class attendance was consistently high, with patients attending on average 14 of 16 sessions.

Compared with controls, significant improvements were seen in the yoga group on the Visual Analog Scale and the Pain Rating Index on Ranked values, both for pain; the Multidimensional Assessment of Fatigue scale; the Pittsburgh Sleep Quality Index; and the Fibromyalgia Health Assessment Questionnaire.

The yoga group did not show significant improvements over time in disability, depression, or active coping scores. The control group showed no significant differences over time, except for worsening anxiety.

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VANCOUVER, B.C. — Yoga may be an effective adjunct to medical treatment for patients with fibromyalgia, Malinda L. Breda, Ph.D., reported at the annual meeting of the American Psychosomatic Society.

There are many reasons why yoga is an attractive treatment for fibromyalgia, which affects about 6 million Americans. Current therapies provide inadequate symptom relief, and a recent metaanalysis concluded that optimal treatment regimens should include nonpharmacologic interventions such as exercise (Ann. Behav. Med. 1999;21:180-91).

But although conventional exercise can alleviate symptoms for some fibromyalgia patients, it actually worsens them in others, said Dr. Breda, of the California School of Professional Psychology, San Diego.

Of 38 adults who met the 1990 American College of Rheumatology criteria for fibromyalgia, 19 were randomized to an experimental yoga group, and 19 controls were put on a waiting list. The yoga intervention consisted of 8 weeks of Classical Hatha Yoga, taught by a certified instructor who had experience with fibromyalgia patients.

The 90-minute sessions emphasized gentle poses and breath-work designed to match individual ability and were followed by relaxation/meditation exercises. Classes were conducted twice weekly, and subjects practiced at home with a video the other 5 days of each week. Class attendance was consistently high, with patients attending on average 14 of 16 sessions.

Compared with controls, significant improvements were seen in the yoga group on the Visual Analog Scale and the Pain Rating Index on Ranked values, both for pain; the Multidimensional Assessment of Fatigue scale; the Pittsburgh Sleep Quality Index; and the Fibromyalgia Health Assessment Questionnaire.

The yoga group did not show significant improvements over time in disability, depression, or active coping scores. The control group showed no significant differences over time, except for worsening anxiety.

VANCOUVER, B.C. — Yoga may be an effective adjunct to medical treatment for patients with fibromyalgia, Malinda L. Breda, Ph.D., reported at the annual meeting of the American Psychosomatic Society.

There are many reasons why yoga is an attractive treatment for fibromyalgia, which affects about 6 million Americans. Current therapies provide inadequate symptom relief, and a recent metaanalysis concluded that optimal treatment regimens should include nonpharmacologic interventions such as exercise (Ann. Behav. Med. 1999;21:180-91).

But although conventional exercise can alleviate symptoms for some fibromyalgia patients, it actually worsens them in others, said Dr. Breda, of the California School of Professional Psychology, San Diego.

Of 38 adults who met the 1990 American College of Rheumatology criteria for fibromyalgia, 19 were randomized to an experimental yoga group, and 19 controls were put on a waiting list. The yoga intervention consisted of 8 weeks of Classical Hatha Yoga, taught by a certified instructor who had experience with fibromyalgia patients.

The 90-minute sessions emphasized gentle poses and breath-work designed to match individual ability and were followed by relaxation/meditation exercises. Classes were conducted twice weekly, and subjects practiced at home with a video the other 5 days of each week. Class attendance was consistently high, with patients attending on average 14 of 16 sessions.

Compared with controls, significant improvements were seen in the yoga group on the Visual Analog Scale and the Pain Rating Index on Ranked values, both for pain; the Multidimensional Assessment of Fatigue scale; the Pittsburgh Sleep Quality Index; and the Fibromyalgia Health Assessment Questionnaire.

The yoga group did not show significant improvements over time in disability, depression, or active coping scores. The control group showed no significant differences over time, except for worsening anxiety.

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Legal Drugs Largely Behind Utah's Rise in Drug-Poisoning Deaths

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A striking rise in drug poisonings in Utah between 1991 and 2003 was largely attributable to medications that can be prescribed legally, the Centers for Disease Control and Prevention said.

Methadone and other prescription narcotics accounted for most of the tripling of the rate of “nonillicit” drug-poisoning deaths that were unintentional or of undetermined intent, from 1.5/100,000 population in 1991-1998 to 4.4/100,000 in 1999-2003.

During the 12-year period, the number of Utah residents dying from all drug poisonings increased nearly fivefold, from 79 (4.4/100,000) in 1991 to 391 (16.6/100,000) in 2003, the CDC said (MMWR 2005;54:33-6).

During 1991-2003, a total of 2,396 drug-poisoning deaths were identified in Utah's centralized medical examiner database.

Of those deaths, 947 were caused by illicit drugs only, 1,277 by nonillicit drugs, and 172 by a combination of the two. Alcohol was not considered a drug in this analysis.) The largest increase in annual drug-poisoning deaths–from 55 in 1991 to 237 in 2003–was attributed to nonillicit drugs, the CDC reported.

Among the deaths attributed to nonillicit drugs during 1991-2003, a total of 733 were classified as unintentional or of undetermined intent. Of these, the highest death rate was among adults aged 25-54 years.

The rate was higher for men than for women, although the percentage increase from 1991-1998 to 1999-2003 was greater among women.

Similarly, more deaths occurred in urban than in rural areas during both periods, but the increase was greater in rural areas And, although death rates rose substantially for people in all body mass index categories, rates were substantially higher during 1999-2003 among overweight (5.26/100,000) and obese individuals (14.25), compared with normal-weight people (3.61).

Comparing the two time periods, the average number of deaths attributable to methadone increased from 2 to 33 per year, while deaths attributable to other prescription narcotics–principally oxycodone and hydrocodone–increased from 10 to 48 per year.

From 1991-1998 to 1999-2003, the proportions of those deaths that involved alcohol decreased from 33% to 20%, while deaths due to antidepressants dropped from 15% to 7%.

During 1997-2002, Utah had an increase in the distribution of many of the prescription drugs implicated in these deaths, including methadone, but that rate of increase was surpassed by the rate of increase in poisoning deaths attributed to them.

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A striking rise in drug poisonings in Utah between 1991 and 2003 was largely attributable to medications that can be prescribed legally, the Centers for Disease Control and Prevention said.

Methadone and other prescription narcotics accounted for most of the tripling of the rate of “nonillicit” drug-poisoning deaths that were unintentional or of undetermined intent, from 1.5/100,000 population in 1991-1998 to 4.4/100,000 in 1999-2003.

During the 12-year period, the number of Utah residents dying from all drug poisonings increased nearly fivefold, from 79 (4.4/100,000) in 1991 to 391 (16.6/100,000) in 2003, the CDC said (MMWR 2005;54:33-6).

During 1991-2003, a total of 2,396 drug-poisoning deaths were identified in Utah's centralized medical examiner database.

Of those deaths, 947 were caused by illicit drugs only, 1,277 by nonillicit drugs, and 172 by a combination of the two. Alcohol was not considered a drug in this analysis.) The largest increase in annual drug-poisoning deaths–from 55 in 1991 to 237 in 2003–was attributed to nonillicit drugs, the CDC reported.

Among the deaths attributed to nonillicit drugs during 1991-2003, a total of 733 were classified as unintentional or of undetermined intent. Of these, the highest death rate was among adults aged 25-54 years.

The rate was higher for men than for women, although the percentage increase from 1991-1998 to 1999-2003 was greater among women.

Similarly, more deaths occurred in urban than in rural areas during both periods, but the increase was greater in rural areas And, although death rates rose substantially for people in all body mass index categories, rates were substantially higher during 1999-2003 among overweight (5.26/100,000) and obese individuals (14.25), compared with normal-weight people (3.61).

Comparing the two time periods, the average number of deaths attributable to methadone increased from 2 to 33 per year, while deaths attributable to other prescription narcotics–principally oxycodone and hydrocodone–increased from 10 to 48 per year.

From 1991-1998 to 1999-2003, the proportions of those deaths that involved alcohol decreased from 33% to 20%, while deaths due to antidepressants dropped from 15% to 7%.

During 1997-2002, Utah had an increase in the distribution of many of the prescription drugs implicated in these deaths, including methadone, but that rate of increase was surpassed by the rate of increase in poisoning deaths attributed to them.

A striking rise in drug poisonings in Utah between 1991 and 2003 was largely attributable to medications that can be prescribed legally, the Centers for Disease Control and Prevention said.

Methadone and other prescription narcotics accounted for most of the tripling of the rate of “nonillicit” drug-poisoning deaths that were unintentional or of undetermined intent, from 1.5/100,000 population in 1991-1998 to 4.4/100,000 in 1999-2003.

During the 12-year period, the number of Utah residents dying from all drug poisonings increased nearly fivefold, from 79 (4.4/100,000) in 1991 to 391 (16.6/100,000) in 2003, the CDC said (MMWR 2005;54:33-6).

During 1991-2003, a total of 2,396 drug-poisoning deaths were identified in Utah's centralized medical examiner database.

Of those deaths, 947 were caused by illicit drugs only, 1,277 by nonillicit drugs, and 172 by a combination of the two. Alcohol was not considered a drug in this analysis.) The largest increase in annual drug-poisoning deaths–from 55 in 1991 to 237 in 2003–was attributed to nonillicit drugs, the CDC reported.

Among the deaths attributed to nonillicit drugs during 1991-2003, a total of 733 were classified as unintentional or of undetermined intent. Of these, the highest death rate was among adults aged 25-54 years.

The rate was higher for men than for women, although the percentage increase from 1991-1998 to 1999-2003 was greater among women.

Similarly, more deaths occurred in urban than in rural areas during both periods, but the increase was greater in rural areas And, although death rates rose substantially for people in all body mass index categories, rates were substantially higher during 1999-2003 among overweight (5.26/100,000) and obese individuals (14.25), compared with normal-weight people (3.61).

Comparing the two time periods, the average number of deaths attributable to methadone increased from 2 to 33 per year, while deaths attributable to other prescription narcotics–principally oxycodone and hydrocodone–increased from 10 to 48 per year.

From 1991-1998 to 1999-2003, the proportions of those deaths that involved alcohol decreased from 33% to 20%, while deaths due to antidepressants dropped from 15% to 7%.

During 1997-2002, Utah had an increase in the distribution of many of the prescription drugs implicated in these deaths, including methadone, but that rate of increase was surpassed by the rate of increase in poisoning deaths attributed to them.

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Pertussis Outbreak Reflects Growing Problem in Teens

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ATLANTA — Pertussis in adolescents is an increasingly reported problem across the United States, Margaret M. Cortese, M.D., said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Preliminary data for 2004 include 8,000 cases reported in adolescents, with large numbers in Wisconsin, upstate New York, Colorado, and Massachusetts. More than 100 cases were reported in adolescents in each of 16 states, while 14 states reported more than 500 cases each in persons of all ages. Moreover, although reporting rates have increased, “these numbers are likely only a portion of the true burden,” said Dr. Cortese, a medical officer with the CDC's National Immunization Program.

Her presentation was among the discussion points during a 4-hour session at the Advisory Committee for Immunization Practices (ACIP) meeting devoted to issues surrounding the pertussis disease burden and to the anticipated licensure of two new reduced-antigen tetanus-diphtheria-acellular pertussis (Tdap) vaccines formulated for use in adolescents.

Both candidate vaccines—Sanofi-Pasteur's Adacel and GlaxoSmithKline's Boostrix—will be reviewed this month by the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee, and ACIP is expected to issue recommendations later this year for their use as adolescent boosters.

In Massachusetts—which is the only state that conducts active surveillance for pertussis using a standardized serologic test for diagnosis—there were 1,088 cases of pertussis among adolescents in 2003, compared with 374 in 2002, 331 in 2001, and 869 in 2000. Of those cases, between 45% and 50% were involved in school outbreaks, Dr. Cortese reported.

Because Massachusetts has such an aggressive surveillance and reporting system for pertussis, its rates are typically about 20 times higher than the reported rates of any other state and “probably give a true indication of the rest of the country,” she noted.

Previously published data have documented significant morbidity and high costs associated with pertussis in adolescents. Among 314 children aged 10-17 years identified in Massachusetts, paroxysmal cough was reported in 74%, difficulty sleeping in 77%, difficulty breathing in 72%, post-tussive vomiting in 56%, and weight loss in 33%. A total of 38% were still coughing at the last interview, done a mean 3.4 months following the initial diagnosis (Clin. Infect. Dis. 2004;39:1572-80).

Those 314 were a subset of a larger group of 1,679 adolescents in whom various cost parameters were assessed. The teenagers made a median of two office visits, and 83% reported missing a mean 5.5 school days, while 43% of their parents/caretakers missed a mean 2.4 days of work.

Average medical cost (including office visits, chest x-rays, and antibiotics) per case was $256, and average nonmedical cost (mostly in missed work) was $160.

These estimates don't include the costs of prophylactic antibiotics for contacts or the public health response, Dr. Cortese noted.

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ATLANTA — Pertussis in adolescents is an increasingly reported problem across the United States, Margaret M. Cortese, M.D., said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Preliminary data for 2004 include 8,000 cases reported in adolescents, with large numbers in Wisconsin, upstate New York, Colorado, and Massachusetts. More than 100 cases were reported in adolescents in each of 16 states, while 14 states reported more than 500 cases each in persons of all ages. Moreover, although reporting rates have increased, “these numbers are likely only a portion of the true burden,” said Dr. Cortese, a medical officer with the CDC's National Immunization Program.

Her presentation was among the discussion points during a 4-hour session at the Advisory Committee for Immunization Practices (ACIP) meeting devoted to issues surrounding the pertussis disease burden and to the anticipated licensure of two new reduced-antigen tetanus-diphtheria-acellular pertussis (Tdap) vaccines formulated for use in adolescents.

Both candidate vaccines—Sanofi-Pasteur's Adacel and GlaxoSmithKline's Boostrix—will be reviewed this month by the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee, and ACIP is expected to issue recommendations later this year for their use as adolescent boosters.

In Massachusetts—which is the only state that conducts active surveillance for pertussis using a standardized serologic test for diagnosis—there were 1,088 cases of pertussis among adolescents in 2003, compared with 374 in 2002, 331 in 2001, and 869 in 2000. Of those cases, between 45% and 50% were involved in school outbreaks, Dr. Cortese reported.

Because Massachusetts has such an aggressive surveillance and reporting system for pertussis, its rates are typically about 20 times higher than the reported rates of any other state and “probably give a true indication of the rest of the country,” she noted.

Previously published data have documented significant morbidity and high costs associated with pertussis in adolescents. Among 314 children aged 10-17 years identified in Massachusetts, paroxysmal cough was reported in 74%, difficulty sleeping in 77%, difficulty breathing in 72%, post-tussive vomiting in 56%, and weight loss in 33%. A total of 38% were still coughing at the last interview, done a mean 3.4 months following the initial diagnosis (Clin. Infect. Dis. 2004;39:1572-80).

Those 314 were a subset of a larger group of 1,679 adolescents in whom various cost parameters were assessed. The teenagers made a median of two office visits, and 83% reported missing a mean 5.5 school days, while 43% of their parents/caretakers missed a mean 2.4 days of work.

Average medical cost (including office visits, chest x-rays, and antibiotics) per case was $256, and average nonmedical cost (mostly in missed work) was $160.

These estimates don't include the costs of prophylactic antibiotics for contacts or the public health response, Dr. Cortese noted.

ATLANTA — Pertussis in adolescents is an increasingly reported problem across the United States, Margaret M. Cortese, M.D., said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Preliminary data for 2004 include 8,000 cases reported in adolescents, with large numbers in Wisconsin, upstate New York, Colorado, and Massachusetts. More than 100 cases were reported in adolescents in each of 16 states, while 14 states reported more than 500 cases each in persons of all ages. Moreover, although reporting rates have increased, “these numbers are likely only a portion of the true burden,” said Dr. Cortese, a medical officer with the CDC's National Immunization Program.

Her presentation was among the discussion points during a 4-hour session at the Advisory Committee for Immunization Practices (ACIP) meeting devoted to issues surrounding the pertussis disease burden and to the anticipated licensure of two new reduced-antigen tetanus-diphtheria-acellular pertussis (Tdap) vaccines formulated for use in adolescents.

Both candidate vaccines—Sanofi-Pasteur's Adacel and GlaxoSmithKline's Boostrix—will be reviewed this month by the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee, and ACIP is expected to issue recommendations later this year for their use as adolescent boosters.

In Massachusetts—which is the only state that conducts active surveillance for pertussis using a standardized serologic test for diagnosis—there were 1,088 cases of pertussis among adolescents in 2003, compared with 374 in 2002, 331 in 2001, and 869 in 2000. Of those cases, between 45% and 50% were involved in school outbreaks, Dr. Cortese reported.

Because Massachusetts has such an aggressive surveillance and reporting system for pertussis, its rates are typically about 20 times higher than the reported rates of any other state and “probably give a true indication of the rest of the country,” she noted.

Previously published data have documented significant morbidity and high costs associated with pertussis in adolescents. Among 314 children aged 10-17 years identified in Massachusetts, paroxysmal cough was reported in 74%, difficulty sleeping in 77%, difficulty breathing in 72%, post-tussive vomiting in 56%, and weight loss in 33%. A total of 38% were still coughing at the last interview, done a mean 3.4 months following the initial diagnosis (Clin. Infect. Dis. 2004;39:1572-80).

Those 314 were a subset of a larger group of 1,679 adolescents in whom various cost parameters were assessed. The teenagers made a median of two office visits, and 83% reported missing a mean 5.5 school days, while 43% of their parents/caretakers missed a mean 2.4 days of work.

Average medical cost (including office visits, chest x-rays, and antibiotics) per case was $256, and average nonmedical cost (mostly in missed work) was $160.

These estimates don't include the costs of prophylactic antibiotics for contacts or the public health response, Dr. Cortese noted.

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Pertussis Cases Show Threat To Infants, Health Care Staff

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Three recent hospital pertussis outbreaks and one infant death from the disease strongly point to the need for improved recognition and protection against transmission, the Centers for Disease Control and Prevention said.

The cases, from four states, also illustrate the potential benefit of vaccination against Bordetella pertussis in adolescents and adults, because immunity from infant immunization wanes after a decade.

No vaccine is currently licensed for persons aged 7 years and above, but two manufacturers have filed for licensure with the Food and Drug Administration for vaccines that combine acellular pertussis, tetanus toxoid, and tetanus toxoid antigens. One would be indicated for persons aged 10-18 years, the other for ages 11-64 years.

All three hospital outbreaks, which occurred in August and September of 2003, involved hospitalized infants with cough illness. In Pennsylvania, a 3-week-old infant was hospitalized with cough, posttussive vomiting, and fever. Pertussis was considered unlikely, the infant wasn't tested for it, and hospital staff did not observe droplet precautions.

The infant was transferred to a referral hospital after 1 day, nasopharyngeal secretions were obtained, and B. pertussis was isolated 16 days later (MMWR 2005;54:67-71).

Meanwhile, the pediatrician who had cared for the infant at the first hospital developed a cough 9 days after exposure. Despite remaining symptomatic, he continued to treat patients—and to have contact with coworkers, family, and friends—without wearing a mask. His nasopharyngeal secretions tested positive 22 days after the initial exposure, while a total of 16 other health care workers and two pediatric patients at the initial hospital developed cough illness and/or tested positive for pertussis.

Hospital infection control personnel subsequently screened exposed employees, treated all who were symptomatic with a 5-day course of azithromycin, and excluded them from work for 5 days. Another 307 close contacts of the symptomatic health care workers were given azithromycin prophylactically, the CDC reported.

The other two outbreaks, in Kentucky and Oregon, also involved acutely ill infants with cough illness, exposed health care workers, and potential transmission to a large number of contacts who subsequently received azithromycin as either treatment or prophylaxis.

All three cases illustrated the difficulties in the diagnosis of pertussis, particularly in older individuals in whom the symptoms during the catarrhal stage are usually nonspecific while the disease is already highly communicable.

In infants, diagnosis may be delayed when the presentation is respiratory distress with apnea but without the typical cough.

Also problematic is the lack of adequate diagnostic tests for pertussis. Culture is not sensitive beyond 3 weeks of illness or after antibiotic therapy, polymerase chain reaction for pertussis is not standardized, and no serologic test is available, although the CDC and the FDA are developing one.

A second MMWR report illustrates the fact that incompletely immunized children aged less than 6 months continue to be the most vulnerable to pertussis when the disease is circulating around them (MMWR 2005;54:71-2).

A 29-day-old West Virginia infant was brought to the emergency department with difficulty breathing. The infant's mother had had prolonged paroxysmal cough illness for 3 weeks before the infant's delivery; the father had onset of paroxysmal cough illness 2 weeks before the infant's illness.

The infant had been coughing for 5 days with increasing severity, resulting in posttussive vomiting and choking. At presentation, she was lethargic, tachycardic, and had a mild fever.

Laboratory results indicated leukocytosis. Chest x-ray revealed pneumonia, and she developed respiratory failure.

She died approximately 30 hours after admission to the pediatric intensive care unit, despite azithromycin treatment for presumed B. pertussis, high-frequency ventilation, nitric oxide administration, and a double-volume exchange transfusion.

The diagnosis of pertussis was based on history, clinical findings, and a positive polymerase chain reaction test. Around the time of the infant's death, two cousins, her paternal grandmother, and a great-grandmother all had cough illness as well.

Treating Pertussis In Health Workers

Clinical Findings

▸ Incubation period: 7-10 days (range: 4-21 days).

▸ Catarrhal stage: 1-2 weeks; coryza, low-grade fever, and mild cough.

▸ Paroxysmal stage: 1-6 weeks; paroxysmal cough, posttussive vomiting, and inspiratory “whoop.”

▸ Convalescent stage: at least 3 weeks; cough gradually lessens and disappears.

Treatment/Prophylaxis

▸ Macrolides (erythromycin, azithromycin, or clarithromycin) are preferred.

▸ Trimethoprim-sulfamethoxazole is an alternative antibiotic that is used in persons with allergy or intolerance to macrolides.

Source: Centers for Disease Control and Prevention

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Three recent hospital pertussis outbreaks and one infant death from the disease strongly point to the need for improved recognition and protection against transmission, the Centers for Disease Control and Prevention said.

The cases, from four states, also illustrate the potential benefit of vaccination against Bordetella pertussis in adolescents and adults, because immunity from infant immunization wanes after a decade.

No vaccine is currently licensed for persons aged 7 years and above, but two manufacturers have filed for licensure with the Food and Drug Administration for vaccines that combine acellular pertussis, tetanus toxoid, and tetanus toxoid antigens. One would be indicated for persons aged 10-18 years, the other for ages 11-64 years.

All three hospital outbreaks, which occurred in August and September of 2003, involved hospitalized infants with cough illness. In Pennsylvania, a 3-week-old infant was hospitalized with cough, posttussive vomiting, and fever. Pertussis was considered unlikely, the infant wasn't tested for it, and hospital staff did not observe droplet precautions.

The infant was transferred to a referral hospital after 1 day, nasopharyngeal secretions were obtained, and B. pertussis was isolated 16 days later (MMWR 2005;54:67-71).

Meanwhile, the pediatrician who had cared for the infant at the first hospital developed a cough 9 days after exposure. Despite remaining symptomatic, he continued to treat patients—and to have contact with coworkers, family, and friends—without wearing a mask. His nasopharyngeal secretions tested positive 22 days after the initial exposure, while a total of 16 other health care workers and two pediatric patients at the initial hospital developed cough illness and/or tested positive for pertussis.

Hospital infection control personnel subsequently screened exposed employees, treated all who were symptomatic with a 5-day course of azithromycin, and excluded them from work for 5 days. Another 307 close contacts of the symptomatic health care workers were given azithromycin prophylactically, the CDC reported.

The other two outbreaks, in Kentucky and Oregon, also involved acutely ill infants with cough illness, exposed health care workers, and potential transmission to a large number of contacts who subsequently received azithromycin as either treatment or prophylaxis.

All three cases illustrated the difficulties in the diagnosis of pertussis, particularly in older individuals in whom the symptoms during the catarrhal stage are usually nonspecific while the disease is already highly communicable.

In infants, diagnosis may be delayed when the presentation is respiratory distress with apnea but without the typical cough.

Also problematic is the lack of adequate diagnostic tests for pertussis. Culture is not sensitive beyond 3 weeks of illness or after antibiotic therapy, polymerase chain reaction for pertussis is not standardized, and no serologic test is available, although the CDC and the FDA are developing one.

A second MMWR report illustrates the fact that incompletely immunized children aged less than 6 months continue to be the most vulnerable to pertussis when the disease is circulating around them (MMWR 2005;54:71-2).

A 29-day-old West Virginia infant was brought to the emergency department with difficulty breathing. The infant's mother had had prolonged paroxysmal cough illness for 3 weeks before the infant's delivery; the father had onset of paroxysmal cough illness 2 weeks before the infant's illness.

The infant had been coughing for 5 days with increasing severity, resulting in posttussive vomiting and choking. At presentation, she was lethargic, tachycardic, and had a mild fever.

Laboratory results indicated leukocytosis. Chest x-ray revealed pneumonia, and she developed respiratory failure.

She died approximately 30 hours after admission to the pediatric intensive care unit, despite azithromycin treatment for presumed B. pertussis, high-frequency ventilation, nitric oxide administration, and a double-volume exchange transfusion.

The diagnosis of pertussis was based on history, clinical findings, and a positive polymerase chain reaction test. Around the time of the infant's death, two cousins, her paternal grandmother, and a great-grandmother all had cough illness as well.

Treating Pertussis In Health Workers

Clinical Findings

▸ Incubation period: 7-10 days (range: 4-21 days).

▸ Catarrhal stage: 1-2 weeks; coryza, low-grade fever, and mild cough.

▸ Paroxysmal stage: 1-6 weeks; paroxysmal cough, posttussive vomiting, and inspiratory “whoop.”

▸ Convalescent stage: at least 3 weeks; cough gradually lessens and disappears.

Treatment/Prophylaxis

▸ Macrolides (erythromycin, azithromycin, or clarithromycin) are preferred.

▸ Trimethoprim-sulfamethoxazole is an alternative antibiotic that is used in persons with allergy or intolerance to macrolides.

Source: Centers for Disease Control and Prevention

Three recent hospital pertussis outbreaks and one infant death from the disease strongly point to the need for improved recognition and protection against transmission, the Centers for Disease Control and Prevention said.

The cases, from four states, also illustrate the potential benefit of vaccination against Bordetella pertussis in adolescents and adults, because immunity from infant immunization wanes after a decade.

No vaccine is currently licensed for persons aged 7 years and above, but two manufacturers have filed for licensure with the Food and Drug Administration for vaccines that combine acellular pertussis, tetanus toxoid, and tetanus toxoid antigens. One would be indicated for persons aged 10-18 years, the other for ages 11-64 years.

All three hospital outbreaks, which occurred in August and September of 2003, involved hospitalized infants with cough illness. In Pennsylvania, a 3-week-old infant was hospitalized with cough, posttussive vomiting, and fever. Pertussis was considered unlikely, the infant wasn't tested for it, and hospital staff did not observe droplet precautions.

The infant was transferred to a referral hospital after 1 day, nasopharyngeal secretions were obtained, and B. pertussis was isolated 16 days later (MMWR 2005;54:67-71).

Meanwhile, the pediatrician who had cared for the infant at the first hospital developed a cough 9 days after exposure. Despite remaining symptomatic, he continued to treat patients—and to have contact with coworkers, family, and friends—without wearing a mask. His nasopharyngeal secretions tested positive 22 days after the initial exposure, while a total of 16 other health care workers and two pediatric patients at the initial hospital developed cough illness and/or tested positive for pertussis.

Hospital infection control personnel subsequently screened exposed employees, treated all who were symptomatic with a 5-day course of azithromycin, and excluded them from work for 5 days. Another 307 close contacts of the symptomatic health care workers were given azithromycin prophylactically, the CDC reported.

The other two outbreaks, in Kentucky and Oregon, also involved acutely ill infants with cough illness, exposed health care workers, and potential transmission to a large number of contacts who subsequently received azithromycin as either treatment or prophylaxis.

All three cases illustrated the difficulties in the diagnosis of pertussis, particularly in older individuals in whom the symptoms during the catarrhal stage are usually nonspecific while the disease is already highly communicable.

In infants, diagnosis may be delayed when the presentation is respiratory distress with apnea but without the typical cough.

Also problematic is the lack of adequate diagnostic tests for pertussis. Culture is not sensitive beyond 3 weeks of illness or after antibiotic therapy, polymerase chain reaction for pertussis is not standardized, and no serologic test is available, although the CDC and the FDA are developing one.

A second MMWR report illustrates the fact that incompletely immunized children aged less than 6 months continue to be the most vulnerable to pertussis when the disease is circulating around them (MMWR 2005;54:71-2).

A 29-day-old West Virginia infant was brought to the emergency department with difficulty breathing. The infant's mother had had prolonged paroxysmal cough illness for 3 weeks before the infant's delivery; the father had onset of paroxysmal cough illness 2 weeks before the infant's illness.

The infant had been coughing for 5 days with increasing severity, resulting in posttussive vomiting and choking. At presentation, she was lethargic, tachycardic, and had a mild fever.

Laboratory results indicated leukocytosis. Chest x-ray revealed pneumonia, and she developed respiratory failure.

She died approximately 30 hours after admission to the pediatric intensive care unit, despite azithromycin treatment for presumed B. pertussis, high-frequency ventilation, nitric oxide administration, and a double-volume exchange transfusion.

The diagnosis of pertussis was based on history, clinical findings, and a positive polymerase chain reaction test. Around the time of the infant's death, two cousins, her paternal grandmother, and a great-grandmother all had cough illness as well.

Treating Pertussis In Health Workers

Clinical Findings

▸ Incubation period: 7-10 days (range: 4-21 days).

▸ Catarrhal stage: 1-2 weeks; coryza, low-grade fever, and mild cough.

▸ Paroxysmal stage: 1-6 weeks; paroxysmal cough, posttussive vomiting, and inspiratory “whoop.”

▸ Convalescent stage: at least 3 weeks; cough gradually lessens and disappears.

Treatment/Prophylaxis

▸ Macrolides (erythromycin, azithromycin, or clarithromycin) are preferred.

▸ Trimethoprim-sulfamethoxazole is an alternative antibiotic that is used in persons with allergy or intolerance to macrolides.

Source: Centers for Disease Control and Prevention

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New ACIP Flu Vaccine Guidelines Focus On Prioritization, Health Care Workers

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ATLANTA — Influenza vaccine recommendations for the 2005-2006 season will seek to minimize disruption in the event of another shortage and will strongly urge annual vaccination of health care workers against influenza.

A risk-based prioritization scheme for the inactivated (injectable) influenza vaccine and a stronger recommendation for immunization of health care workers with the live attenuated influenza vaccine (LAIV, or FluMist) are among the proposed changes to the yearly influenza vaccine statement discussed at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

There is no concrete information to suggest that there will be flu vaccine supply problems again next fall, but disruptions have occurred in four of the five previous seasons. Contributing factors have included production issues and regulatory actions. In addition, two manufacturers have left the market.

Thus “there is uncertainty about the 2005-2006 vaccine supply,” Keiji Fukuda, M.D., of the CDC's influenza branch, told the committee.

Although the final language was still being worked out at press time, ACIP voted in principle to support a three-tiered prioritization system in which high-risk groups are ranked based on rates of influenza-associated mortality and hospitalization in the United States. (See box.)

The tiering scheme applies only to the inactivated influenza vaccine, and the document is expected to contain a strong recommendation for the preferential use of LAIV for healthy persons aged 5-49 years—particularly health care workers—in the event of a shortage.

During periods of vaccine shortfall, persons listed in tier 1 should be vaccinated preferentially, followed by tiers 2 and 3. The subdivisions within tier 1 would be used only in the unlikely event that the local vaccine supply is extremely limited. Should that occur, state and local health officials should vaccinate the two populations in tier 1A—those aged 65 and older with comorbid conditions and long-term care facility residents—before all others.

In all other vaccine shortfall situations, populations falling into tiers 1A, 1B, and 1C should be considered equivalent and should be vaccinated simultaneously. Eligible individuals in tiers 1C, 2, and 3 should be encouraged to receive LAIV (those in tier 1C—health care personnel and close contacts of children less than 6 months of age—could receive either the injectable vaccine or LAIV, depending upon supply circumstances).

The committee also voted to include much stronger language about immunization of health care workers overall, regardless of vaccine supply status. Among the likely recommendations are that campaigns be organized to encourage workplace efforts to improve immunization rates among health care workers, and that such rates be regularly measured and reported.

“Giving the influenza vaccine to health care workers keeps them at work. It becomes a quality issue,” said ACIP member Jon S. Abramson, M.D. “When you increase the number of patients a nurse has to take care of [due to absenteeism], it affects patient outcome.”

Proposed Tiering in the Event of an Influenza Vaccine Shortage

Group 1A

▸ Aged 65 years and older with comorbid conditions.

▸ Long-term care facility residents.

Group 1B

▸ Pregnant women.

▸ Aged 2-64 years with comorbid conditions.

▸ Aged 65 years and older without comorbid conditions.

▸ Aged 6-23 months.

Group 1C

▸ Health care personnel.

▸ Close contacts of children less than 6 months of age.

Group 2

▸ Contacts of high-risk children and adults.

▸ Healthy persons aged 50-64 years.

Group 3

▸ Aged 2-49 years without high-risk conditions.

Source: Dr. Fukuda

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ATLANTA — Influenza vaccine recommendations for the 2005-2006 season will seek to minimize disruption in the event of another shortage and will strongly urge annual vaccination of health care workers against influenza.

A risk-based prioritization scheme for the inactivated (injectable) influenza vaccine and a stronger recommendation for immunization of health care workers with the live attenuated influenza vaccine (LAIV, or FluMist) are among the proposed changes to the yearly influenza vaccine statement discussed at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

There is no concrete information to suggest that there will be flu vaccine supply problems again next fall, but disruptions have occurred in four of the five previous seasons. Contributing factors have included production issues and regulatory actions. In addition, two manufacturers have left the market.

Thus “there is uncertainty about the 2005-2006 vaccine supply,” Keiji Fukuda, M.D., of the CDC's influenza branch, told the committee.

Although the final language was still being worked out at press time, ACIP voted in principle to support a three-tiered prioritization system in which high-risk groups are ranked based on rates of influenza-associated mortality and hospitalization in the United States. (See box.)

The tiering scheme applies only to the inactivated influenza vaccine, and the document is expected to contain a strong recommendation for the preferential use of LAIV for healthy persons aged 5-49 years—particularly health care workers—in the event of a shortage.

During periods of vaccine shortfall, persons listed in tier 1 should be vaccinated preferentially, followed by tiers 2 and 3. The subdivisions within tier 1 would be used only in the unlikely event that the local vaccine supply is extremely limited. Should that occur, state and local health officials should vaccinate the two populations in tier 1A—those aged 65 and older with comorbid conditions and long-term care facility residents—before all others.

In all other vaccine shortfall situations, populations falling into tiers 1A, 1B, and 1C should be considered equivalent and should be vaccinated simultaneously. Eligible individuals in tiers 1C, 2, and 3 should be encouraged to receive LAIV (those in tier 1C—health care personnel and close contacts of children less than 6 months of age—could receive either the injectable vaccine or LAIV, depending upon supply circumstances).

The committee also voted to include much stronger language about immunization of health care workers overall, regardless of vaccine supply status. Among the likely recommendations are that campaigns be organized to encourage workplace efforts to improve immunization rates among health care workers, and that such rates be regularly measured and reported.

“Giving the influenza vaccine to health care workers keeps them at work. It becomes a quality issue,” said ACIP member Jon S. Abramson, M.D. “When you increase the number of patients a nurse has to take care of [due to absenteeism], it affects patient outcome.”

Proposed Tiering in the Event of an Influenza Vaccine Shortage

Group 1A

▸ Aged 65 years and older with comorbid conditions.

▸ Long-term care facility residents.

Group 1B

▸ Pregnant women.

▸ Aged 2-64 years with comorbid conditions.

▸ Aged 65 years and older without comorbid conditions.

▸ Aged 6-23 months.

Group 1C

▸ Health care personnel.

▸ Close contacts of children less than 6 months of age.

Group 2

▸ Contacts of high-risk children and adults.

▸ Healthy persons aged 50-64 years.

Group 3

▸ Aged 2-49 years without high-risk conditions.

Source: Dr. Fukuda

ATLANTA — Influenza vaccine recommendations for the 2005-2006 season will seek to minimize disruption in the event of another shortage and will strongly urge annual vaccination of health care workers against influenza.

A risk-based prioritization scheme for the inactivated (injectable) influenza vaccine and a stronger recommendation for immunization of health care workers with the live attenuated influenza vaccine (LAIV, or FluMist) are among the proposed changes to the yearly influenza vaccine statement discussed at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

There is no concrete information to suggest that there will be flu vaccine supply problems again next fall, but disruptions have occurred in four of the five previous seasons. Contributing factors have included production issues and regulatory actions. In addition, two manufacturers have left the market.

Thus “there is uncertainty about the 2005-2006 vaccine supply,” Keiji Fukuda, M.D., of the CDC's influenza branch, told the committee.

Although the final language was still being worked out at press time, ACIP voted in principle to support a three-tiered prioritization system in which high-risk groups are ranked based on rates of influenza-associated mortality and hospitalization in the United States. (See box.)

The tiering scheme applies only to the inactivated influenza vaccine, and the document is expected to contain a strong recommendation for the preferential use of LAIV for healthy persons aged 5-49 years—particularly health care workers—in the event of a shortage.

During periods of vaccine shortfall, persons listed in tier 1 should be vaccinated preferentially, followed by tiers 2 and 3. The subdivisions within tier 1 would be used only in the unlikely event that the local vaccine supply is extremely limited. Should that occur, state and local health officials should vaccinate the two populations in tier 1A—those aged 65 and older with comorbid conditions and long-term care facility residents—before all others.

In all other vaccine shortfall situations, populations falling into tiers 1A, 1B, and 1C should be considered equivalent and should be vaccinated simultaneously. Eligible individuals in tiers 1C, 2, and 3 should be encouraged to receive LAIV (those in tier 1C—health care personnel and close contacts of children less than 6 months of age—could receive either the injectable vaccine or LAIV, depending upon supply circumstances).

The committee also voted to include much stronger language about immunization of health care workers overall, regardless of vaccine supply status. Among the likely recommendations are that campaigns be organized to encourage workplace efforts to improve immunization rates among health care workers, and that such rates be regularly measured and reported.

“Giving the influenza vaccine to health care workers keeps them at work. It becomes a quality issue,” said ACIP member Jon S. Abramson, M.D. “When you increase the number of patients a nurse has to take care of [due to absenteeism], it affects patient outcome.”

Proposed Tiering in the Event of an Influenza Vaccine Shortage

Group 1A

▸ Aged 65 years and older with comorbid conditions.

▸ Long-term care facility residents.

Group 1B

▸ Pregnant women.

▸ Aged 2-64 years with comorbid conditions.

▸ Aged 65 years and older without comorbid conditions.

▸ Aged 6-23 months.

Group 1C

▸ Health care personnel.

▸ Close contacts of children less than 6 months of age.

Group 2

▸ Contacts of high-risk children and adults.

▸ Healthy persons aged 50-64 years.

Group 3

▸ Aged 2-49 years without high-risk conditions.

Source: Dr. Fukuda

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Urinary PlGF Predicts Early-Onset Preeclampsia

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VIENNA — Decreased urinary placental growth factor at midgestation is strongly associated with the subsequent development of early-onset preeclampsia, S. Ananth Karumanchi, M.D., reported.

“Low urinary PlGF antedates the clinical diagnosis of preeclampsia and may serve as a screening test to predict who will develop early-onset disease,” Dr. Karumanchi said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

The findings, published soon after the congress, come from a nested case-control study within the Calcium for Preeclampsia Prevention trial of healthy nulliparous women enrolled at five U.S. university medical centers during 1992–95. Frozen serum and urine samples from 120 women with preeclampsia were compared with those of 120 matched normotensive controls (JAMA 2005;293:77–85).

In all the women, urinary PlGF levels increased during the first two trimesters, with a more rapid increase after 21–24 weeks and a peak at 29–33 weeks. However, those levels were significantly lower among the women who subsequently developed preeclampsia at weeks 25–28, 29–32, and 33–36. Differences were particularly large between the controls and the women who subsequently developed preeclampsia before 37 weeks or who had preeclampsia with a small-for-gestational age (SGA) infant.

Alterations in urinary PlGF levels at 21–32 weeks were also more pronounced in women who subsequently developed pre-eclampsia before 37 weeks (87 pg/mL) than among those who had onset of preeclampsia at term (223 pg/mL).

At 33–42 weeks, those levels were 22 vs. 118 pg/mL, lead author Richard J. Levine, M.D., of the National Institute of Child Health and Human Development, Bethesda, Md., and his associates reported in the published article.

The women were divided by quartiles of urinary PlGF obtained at 21–32 weeks' gestation and the results adjusted for gestational age at specimen collection, storage time, body mass index, and maternal age.

Compared with women in the upper three quartiles, the odds ratio was 22.5 for later development of preterm preeclampsia among the women with PlGF concentrations in the lowest quartile (less than 118 pg/mL).

The association was even stronger when restricted to just morning urine specimens, with an odds ratio of 39.5.

For term pre-eclampsia, the adjusted odds ratios of lowest vs. the upper three quartiles of PlGF concentration were 2.2 at 21–32 weeks and 2.3 at 33–42 weeks' gestation.

The data also suggested a strong association between low urinary PlGF and a substantially increased risk for preeclampsia with an SGA infant, but the numbers were too small to make a stable estimate, Dr. Levine and his associates noted.

Adjusting the results for urinary creatinine concentration did not change the strength of the associations, they said.

Previous data from this research group showed that increased circulating serum levels of the angiogenic factor soluble fms-like tyrosine kinase (sFlt-1) were predictive of subsequent preeclampsia (N. Engl. J. Med. 2004;350:672–83).

But because the sFlt-1 molecule is too large to be filtered into urine, the current study focused on PlGF, which binds to sFlt-1, as a more clinically feasible alternative. If a reliable dipstick assay could be developed for urine screening of all pregnant women for urine PlGF, then subsequent serum measurements of both PlGF and sFlt-1 could minimize false-positive results from urine testing, the investigators suggested.

At the congress, Dr. Karumanchi, a nephrologist at Beth Israel Deaconess Medical Center, Boston, said, “Obviously, this is a retrospective study done using specimens frozen for several years, and we don't know if it can be reproduced prospectively. Nevertheless, it does prove the hypothesis that angiogenic factors play a critical role in the pathogenesis of this syndrome.”

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VIENNA — Decreased urinary placental growth factor at midgestation is strongly associated with the subsequent development of early-onset preeclampsia, S. Ananth Karumanchi, M.D., reported.

“Low urinary PlGF antedates the clinical diagnosis of preeclampsia and may serve as a screening test to predict who will develop early-onset disease,” Dr. Karumanchi said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

The findings, published soon after the congress, come from a nested case-control study within the Calcium for Preeclampsia Prevention trial of healthy nulliparous women enrolled at five U.S. university medical centers during 1992–95. Frozen serum and urine samples from 120 women with preeclampsia were compared with those of 120 matched normotensive controls (JAMA 2005;293:77–85).

In all the women, urinary PlGF levels increased during the first two trimesters, with a more rapid increase after 21–24 weeks and a peak at 29–33 weeks. However, those levels were significantly lower among the women who subsequently developed preeclampsia at weeks 25–28, 29–32, and 33–36. Differences were particularly large between the controls and the women who subsequently developed preeclampsia before 37 weeks or who had preeclampsia with a small-for-gestational age (SGA) infant.

Alterations in urinary PlGF levels at 21–32 weeks were also more pronounced in women who subsequently developed pre-eclampsia before 37 weeks (87 pg/mL) than among those who had onset of preeclampsia at term (223 pg/mL).

At 33–42 weeks, those levels were 22 vs. 118 pg/mL, lead author Richard J. Levine, M.D., of the National Institute of Child Health and Human Development, Bethesda, Md., and his associates reported in the published article.

The women were divided by quartiles of urinary PlGF obtained at 21–32 weeks' gestation and the results adjusted for gestational age at specimen collection, storage time, body mass index, and maternal age.

Compared with women in the upper three quartiles, the odds ratio was 22.5 for later development of preterm preeclampsia among the women with PlGF concentrations in the lowest quartile (less than 118 pg/mL).

The association was even stronger when restricted to just morning urine specimens, with an odds ratio of 39.5.

For term pre-eclampsia, the adjusted odds ratios of lowest vs. the upper three quartiles of PlGF concentration were 2.2 at 21–32 weeks and 2.3 at 33–42 weeks' gestation.

The data also suggested a strong association between low urinary PlGF and a substantially increased risk for preeclampsia with an SGA infant, but the numbers were too small to make a stable estimate, Dr. Levine and his associates noted.

Adjusting the results for urinary creatinine concentration did not change the strength of the associations, they said.

Previous data from this research group showed that increased circulating serum levels of the angiogenic factor soluble fms-like tyrosine kinase (sFlt-1) were predictive of subsequent preeclampsia (N. Engl. J. Med. 2004;350:672–83).

But because the sFlt-1 molecule is too large to be filtered into urine, the current study focused on PlGF, which binds to sFlt-1, as a more clinically feasible alternative. If a reliable dipstick assay could be developed for urine screening of all pregnant women for urine PlGF, then subsequent serum measurements of both PlGF and sFlt-1 could minimize false-positive results from urine testing, the investigators suggested.

At the congress, Dr. Karumanchi, a nephrologist at Beth Israel Deaconess Medical Center, Boston, said, “Obviously, this is a retrospective study done using specimens frozen for several years, and we don't know if it can be reproduced prospectively. Nevertheless, it does prove the hypothesis that angiogenic factors play a critical role in the pathogenesis of this syndrome.”

VIENNA — Decreased urinary placental growth factor at midgestation is strongly associated with the subsequent development of early-onset preeclampsia, S. Ananth Karumanchi, M.D., reported.

“Low urinary PlGF antedates the clinical diagnosis of preeclampsia and may serve as a screening test to predict who will develop early-onset disease,” Dr. Karumanchi said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

The findings, published soon after the congress, come from a nested case-control study within the Calcium for Preeclampsia Prevention trial of healthy nulliparous women enrolled at five U.S. university medical centers during 1992–95. Frozen serum and urine samples from 120 women with preeclampsia were compared with those of 120 matched normotensive controls (JAMA 2005;293:77–85).

In all the women, urinary PlGF levels increased during the first two trimesters, with a more rapid increase after 21–24 weeks and a peak at 29–33 weeks. However, those levels were significantly lower among the women who subsequently developed preeclampsia at weeks 25–28, 29–32, and 33–36. Differences were particularly large between the controls and the women who subsequently developed preeclampsia before 37 weeks or who had preeclampsia with a small-for-gestational age (SGA) infant.

Alterations in urinary PlGF levels at 21–32 weeks were also more pronounced in women who subsequently developed pre-eclampsia before 37 weeks (87 pg/mL) than among those who had onset of preeclampsia at term (223 pg/mL).

At 33–42 weeks, those levels were 22 vs. 118 pg/mL, lead author Richard J. Levine, M.D., of the National Institute of Child Health and Human Development, Bethesda, Md., and his associates reported in the published article.

The women were divided by quartiles of urinary PlGF obtained at 21–32 weeks' gestation and the results adjusted for gestational age at specimen collection, storage time, body mass index, and maternal age.

Compared with women in the upper three quartiles, the odds ratio was 22.5 for later development of preterm preeclampsia among the women with PlGF concentrations in the lowest quartile (less than 118 pg/mL).

The association was even stronger when restricted to just morning urine specimens, with an odds ratio of 39.5.

For term pre-eclampsia, the adjusted odds ratios of lowest vs. the upper three quartiles of PlGF concentration were 2.2 at 21–32 weeks and 2.3 at 33–42 weeks' gestation.

The data also suggested a strong association between low urinary PlGF and a substantially increased risk for preeclampsia with an SGA infant, but the numbers were too small to make a stable estimate, Dr. Levine and his associates noted.

Adjusting the results for urinary creatinine concentration did not change the strength of the associations, they said.

Previous data from this research group showed that increased circulating serum levels of the angiogenic factor soluble fms-like tyrosine kinase (sFlt-1) were predictive of subsequent preeclampsia (N. Engl. J. Med. 2004;350:672–83).

But because the sFlt-1 molecule is too large to be filtered into urine, the current study focused on PlGF, which binds to sFlt-1, as a more clinically feasible alternative. If a reliable dipstick assay could be developed for urine screening of all pregnant women for urine PlGF, then subsequent serum measurements of both PlGF and sFlt-1 could minimize false-positive results from urine testing, the investigators suggested.

At the congress, Dr. Karumanchi, a nephrologist at Beth Israel Deaconess Medical Center, Boston, said, “Obviously, this is a retrospective study done using specimens frozen for several years, and we don't know if it can be reproduced prospectively. Nevertheless, it does prove the hypothesis that angiogenic factors play a critical role in the pathogenesis of this syndrome.”

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Tdap Shot Can Fit in to Preteen Visit, Surveyed Doctors Say

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ATLANTA — Physicians who take care of adolescents are likely to accept routine vaccination of 11- to 12-year-olds with a tetanus-diphtheria-acellular pertussis vaccine instead of the current tetanus-diphtheria vaccine, Karen R. Broder, M.D., reported at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

However, preliminary survey data suggest that vaccinating older adolescents might prove trickier, and that vaccination practices are likely to differ between family physicians and pediatricians, said Dr. Broder, a medical officer with the CDC's National Immunization Program.

In anticipation of the expected licensure of two new specially formulated adolescent tetanus-diphtheria-acellular pertussis (Tdap) vaccines, the University of Michigan and the CDC surveyed approximately 600 randomly selected U.S. pediatricians and family physicians. A total of 154 pediatricians and 143 family physicians returned the surveys and said they provided outpatient primary care to one or more adolescents (aged 11–18 years) per week.

Most of the physicians (75% of pediatricians and 66% of family physicians) worked in private, independent office settings, while 19% of the family physicians worked in practice networks/HMOs, compared with just 7% of the pediatricians.

Both specialties reported high current rates of administering tetanus-diphtheria toxoids (Td) when indicated for wound management (73% pediatricians/83% family physicians) and for camp and/or school requirements (83%/79%). However, while 77% of pediatricians said they routinely gave Td vaccine to 11- to 12-year-olds at preventive care visits, just 51% of family physicians reported doing so.

Among the surveyed physicians, the reported “major” barriers to current adolescent Td vaccination included “lack of patient visits” for 40% of pediatricians and 48% of family physicians; “record keeping” for 11% and 24%, respectively; “reimbursement” for 3% and 17%; and “too busy” by 2% of pediatricians and 7% of family physicians. “No barrier” was reported by 47% of pediatricians and 32% of family physicians.

A total of 70% of pediatricians versus 42% of family physicians either agreed or strongly agreed with the statement that pertussis is a “serious enough disease” to use Tdap for adolescents, rather than Td, she noted.

In a separate survey of a different but comparable group of physicians, 63% of pediatricians and 35% of family physicians reported that more than half of their adolescent patients have a routine preventive visit at 11–12 years, while 44% of pediatricians and 27% of family physicians reported the same for those aged 14–15 years, compared with just 30% and 15%, respectively, at 17–18 years.

A total of 84% of pediatricians and 59% of family physicians said that more than half of their patients received a Td booster at any time between the ages of 11 and 18 years, suggesting more than 50% coverage. By comparison, the 2002 National Health Interview Survey found that just 33% of those aged 13–15 years had a Td dose listed in their shot cards, while coverage for Td varied from 48% to 97% in three states with Td school laws for middle-schoolers, Dr. Broder noted.

In addition to ACIP's expected recommendation for routine Tdap vaccination at the 11- to 12-year-old preventive visit, the committee is also considering a “first opportunity” strategy in which the vaccine would be given to any teenager who had received Td more than 5 years earlier (an interval of 5 years is required to minimize adverse events). These survey data suggest that such a strategy “might pose challenges,” Dr. Broder remarked.

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ATLANTA — Physicians who take care of adolescents are likely to accept routine vaccination of 11- to 12-year-olds with a tetanus-diphtheria-acellular pertussis vaccine instead of the current tetanus-diphtheria vaccine, Karen R. Broder, M.D., reported at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

However, preliminary survey data suggest that vaccinating older adolescents might prove trickier, and that vaccination practices are likely to differ between family physicians and pediatricians, said Dr. Broder, a medical officer with the CDC's National Immunization Program.

In anticipation of the expected licensure of two new specially formulated adolescent tetanus-diphtheria-acellular pertussis (Tdap) vaccines, the University of Michigan and the CDC surveyed approximately 600 randomly selected U.S. pediatricians and family physicians. A total of 154 pediatricians and 143 family physicians returned the surveys and said they provided outpatient primary care to one or more adolescents (aged 11–18 years) per week.

Most of the physicians (75% of pediatricians and 66% of family physicians) worked in private, independent office settings, while 19% of the family physicians worked in practice networks/HMOs, compared with just 7% of the pediatricians.

Both specialties reported high current rates of administering tetanus-diphtheria toxoids (Td) when indicated for wound management (73% pediatricians/83% family physicians) and for camp and/or school requirements (83%/79%). However, while 77% of pediatricians said they routinely gave Td vaccine to 11- to 12-year-olds at preventive care visits, just 51% of family physicians reported doing so.

Among the surveyed physicians, the reported “major” barriers to current adolescent Td vaccination included “lack of patient visits” for 40% of pediatricians and 48% of family physicians; “record keeping” for 11% and 24%, respectively; “reimbursement” for 3% and 17%; and “too busy” by 2% of pediatricians and 7% of family physicians. “No barrier” was reported by 47% of pediatricians and 32% of family physicians.

A total of 70% of pediatricians versus 42% of family physicians either agreed or strongly agreed with the statement that pertussis is a “serious enough disease” to use Tdap for adolescents, rather than Td, she noted.

In a separate survey of a different but comparable group of physicians, 63% of pediatricians and 35% of family physicians reported that more than half of their adolescent patients have a routine preventive visit at 11–12 years, while 44% of pediatricians and 27% of family physicians reported the same for those aged 14–15 years, compared with just 30% and 15%, respectively, at 17–18 years.

A total of 84% of pediatricians and 59% of family physicians said that more than half of their patients received a Td booster at any time between the ages of 11 and 18 years, suggesting more than 50% coverage. By comparison, the 2002 National Health Interview Survey found that just 33% of those aged 13–15 years had a Td dose listed in their shot cards, while coverage for Td varied from 48% to 97% in three states with Td school laws for middle-schoolers, Dr. Broder noted.

In addition to ACIP's expected recommendation for routine Tdap vaccination at the 11- to 12-year-old preventive visit, the committee is also considering a “first opportunity” strategy in which the vaccine would be given to any teenager who had received Td more than 5 years earlier (an interval of 5 years is required to minimize adverse events). These survey data suggest that such a strategy “might pose challenges,” Dr. Broder remarked.

ATLANTA — Physicians who take care of adolescents are likely to accept routine vaccination of 11- to 12-year-olds with a tetanus-diphtheria-acellular pertussis vaccine instead of the current tetanus-diphtheria vaccine, Karen R. Broder, M.D., reported at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

However, preliminary survey data suggest that vaccinating older adolescents might prove trickier, and that vaccination practices are likely to differ between family physicians and pediatricians, said Dr. Broder, a medical officer with the CDC's National Immunization Program.

In anticipation of the expected licensure of two new specially formulated adolescent tetanus-diphtheria-acellular pertussis (Tdap) vaccines, the University of Michigan and the CDC surveyed approximately 600 randomly selected U.S. pediatricians and family physicians. A total of 154 pediatricians and 143 family physicians returned the surveys and said they provided outpatient primary care to one or more adolescents (aged 11–18 years) per week.

Most of the physicians (75% of pediatricians and 66% of family physicians) worked in private, independent office settings, while 19% of the family physicians worked in practice networks/HMOs, compared with just 7% of the pediatricians.

Both specialties reported high current rates of administering tetanus-diphtheria toxoids (Td) when indicated for wound management (73% pediatricians/83% family physicians) and for camp and/or school requirements (83%/79%). However, while 77% of pediatricians said they routinely gave Td vaccine to 11- to 12-year-olds at preventive care visits, just 51% of family physicians reported doing so.

Among the surveyed physicians, the reported “major” barriers to current adolescent Td vaccination included “lack of patient visits” for 40% of pediatricians and 48% of family physicians; “record keeping” for 11% and 24%, respectively; “reimbursement” for 3% and 17%; and “too busy” by 2% of pediatricians and 7% of family physicians. “No barrier” was reported by 47% of pediatricians and 32% of family physicians.

A total of 70% of pediatricians versus 42% of family physicians either agreed or strongly agreed with the statement that pertussis is a “serious enough disease” to use Tdap for adolescents, rather than Td, she noted.

In a separate survey of a different but comparable group of physicians, 63% of pediatricians and 35% of family physicians reported that more than half of their adolescent patients have a routine preventive visit at 11–12 years, while 44% of pediatricians and 27% of family physicians reported the same for those aged 14–15 years, compared with just 30% and 15%, respectively, at 17–18 years.

A total of 84% of pediatricians and 59% of family physicians said that more than half of their patients received a Td booster at any time between the ages of 11 and 18 years, suggesting more than 50% coverage. By comparison, the 2002 National Health Interview Survey found that just 33% of those aged 13–15 years had a Td dose listed in their shot cards, while coverage for Td varied from 48% to 97% in three states with Td school laws for middle-schoolers, Dr. Broder noted.

In addition to ACIP's expected recommendation for routine Tdap vaccination at the 11- to 12-year-old preventive visit, the committee is also considering a “first opportunity” strategy in which the vaccine would be given to any teenager who had received Td more than 5 years earlier (an interval of 5 years is required to minimize adverse events). These survey data suggest that such a strategy “might pose challenges,” Dr. Broder remarked.

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