Ethnicity Seems to Play a Role In Teens' Eating Disorder Risk

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Culture appears to play a role in disordered eating.

Black and Caribbean girls had the lowest rates of disordered eating, probably because African American culture sends teens the message that their physically attractiveness isn't completely tied to being thin, Katarzyna Bisaga, M.D., and colleagues reported.

“These findings, along with previously described higher ideal body weight among [black] girls, support the protective role of cultural values with regards to restrictive weight control behaviors,” said Dr. Bisaga of the New York State Psychiatric Institute, New York.

Conversely, white and Hispanic girls had much higher rates of disordered eating. This seems directly related to the cultural message that being thin is a prerequisite for being attractive, said the investigators.

There also was a significant association between early dieting and depressive disorder symptoms among white girls and those of mixed background. “This finding suggests that Western cultural pressures for thinness may play a role not only in the development of EDS [eating disorder symptoms], but also in the development of DDS [depressive disorder symptoms] in adolescence,” they said (J. Dev. Behav. Pediatr. 2005;26:257–66).

The investigators examined symptoms of eating disorder and depression among 1,445 teenaged girls (mean age 16 years) in five high schools. All girls took the Eating Attitudes Test-26 and the Short Mood and Feelings Questionnaire.

No ethnic group was immune to symptoms of disordered eating; however, there were significant differences in the scores. Black and Caribbean girls had the lowest proportion of high scores (9% and 6.5%), while white and Hispanic girls had higher proportions of high scores (16%). Asian girls fell in the middle (13%).

Black, Caribbean, and Hispanic girls were more likely to binge eat than white or Asian girls, while mixed background, white, and Hispanic girls were more likely to engage in self-induced vomiting.

Scores on the Short Mood and Feelings Questionnaire were highest among Asian girls and lowest among black girls. White girls and those of mixed background were most likely to have a correlation between depressive symptoms and early dieting.

Hispanic girls seem particularly at risk for eating disorder symptoms.

“They started dieting, engaged in self-induced vomiting, and used diet pills at an earlier age than Caribbean and African American girls. These findings add to the accumulating evidence that Hispanic girls are at high risk for eating disorders,” the investigators said.

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Culture appears to play a role in disordered eating.

Black and Caribbean girls had the lowest rates of disordered eating, probably because African American culture sends teens the message that their physically attractiveness isn't completely tied to being thin, Katarzyna Bisaga, M.D., and colleagues reported.

“These findings, along with previously described higher ideal body weight among [black] girls, support the protective role of cultural values with regards to restrictive weight control behaviors,” said Dr. Bisaga of the New York State Psychiatric Institute, New York.

Conversely, white and Hispanic girls had much higher rates of disordered eating. This seems directly related to the cultural message that being thin is a prerequisite for being attractive, said the investigators.

There also was a significant association between early dieting and depressive disorder symptoms among white girls and those of mixed background. “This finding suggests that Western cultural pressures for thinness may play a role not only in the development of EDS [eating disorder symptoms], but also in the development of DDS [depressive disorder symptoms] in adolescence,” they said (J. Dev. Behav. Pediatr. 2005;26:257–66).

The investigators examined symptoms of eating disorder and depression among 1,445 teenaged girls (mean age 16 years) in five high schools. All girls took the Eating Attitudes Test-26 and the Short Mood and Feelings Questionnaire.

No ethnic group was immune to symptoms of disordered eating; however, there were significant differences in the scores. Black and Caribbean girls had the lowest proportion of high scores (9% and 6.5%), while white and Hispanic girls had higher proportions of high scores (16%). Asian girls fell in the middle (13%).

Black, Caribbean, and Hispanic girls were more likely to binge eat than white or Asian girls, while mixed background, white, and Hispanic girls were more likely to engage in self-induced vomiting.

Scores on the Short Mood and Feelings Questionnaire were highest among Asian girls and lowest among black girls. White girls and those of mixed background were most likely to have a correlation between depressive symptoms and early dieting.

Hispanic girls seem particularly at risk for eating disorder symptoms.

“They started dieting, engaged in self-induced vomiting, and used diet pills at an earlier age than Caribbean and African American girls. These findings add to the accumulating evidence that Hispanic girls are at high risk for eating disorders,” the investigators said.

Culture appears to play a role in disordered eating.

Black and Caribbean girls had the lowest rates of disordered eating, probably because African American culture sends teens the message that their physically attractiveness isn't completely tied to being thin, Katarzyna Bisaga, M.D., and colleagues reported.

“These findings, along with previously described higher ideal body weight among [black] girls, support the protective role of cultural values with regards to restrictive weight control behaviors,” said Dr. Bisaga of the New York State Psychiatric Institute, New York.

Conversely, white and Hispanic girls had much higher rates of disordered eating. This seems directly related to the cultural message that being thin is a prerequisite for being attractive, said the investigators.

There also was a significant association between early dieting and depressive disorder symptoms among white girls and those of mixed background. “This finding suggests that Western cultural pressures for thinness may play a role not only in the development of EDS [eating disorder symptoms], but also in the development of DDS [depressive disorder symptoms] in adolescence,” they said (J. Dev. Behav. Pediatr. 2005;26:257–66).

The investigators examined symptoms of eating disorder and depression among 1,445 teenaged girls (mean age 16 years) in five high schools. All girls took the Eating Attitudes Test-26 and the Short Mood and Feelings Questionnaire.

No ethnic group was immune to symptoms of disordered eating; however, there were significant differences in the scores. Black and Caribbean girls had the lowest proportion of high scores (9% and 6.5%), while white and Hispanic girls had higher proportions of high scores (16%). Asian girls fell in the middle (13%).

Black, Caribbean, and Hispanic girls were more likely to binge eat than white or Asian girls, while mixed background, white, and Hispanic girls were more likely to engage in self-induced vomiting.

Scores on the Short Mood and Feelings Questionnaire were highest among Asian girls and lowest among black girls. White girls and those of mixed background were most likely to have a correlation between depressive symptoms and early dieting.

Hispanic girls seem particularly at risk for eating disorder symptoms.

“They started dieting, engaged in self-induced vomiting, and used diet pills at an earlier age than Caribbean and African American girls. These findings add to the accumulating evidence that Hispanic girls are at high risk for eating disorders,” the investigators said.

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Weight Loss Reduces Breast Ca Risk in BRCA-Positive Women

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Weight Loss Reduces Breast Ca Risk in BRCA-Positive Women

A weight loss of at least 10 pounds will significantly decrease the risk of early-onset breast cancer in women who carry a BRCA mutation, according to results of a large case-control study.

Early-adulthood weight loss is especially important for women with the BRCA1 mutation. Among these women, the weight loss was associated with a 65% reduction in cancer risk, compared with a reference group of BRCA1 carriers, according to Joanne Kotsopoulos, a doctoral student at the University of Toronto, and her research colleagues (Breast Cancer Res. 2005;7:R833–43; doi 10.1186/bcr1293, online at breastcancerresearch.com/content/7/5/R833

The investigators examined early-onset breast cancer in 1,073 matched case-control pairs; about 75% had BRCA1 mutations and 25% had BRCA2 mutations.

Weight loss of at least 10 pounds between age 18 and 30 resulted in an overall 34% reduction in the risk of breast cancer. The risk reduction was greater (63%) for breast cancers diagnosed between ages 30 and 40, but not significant for breast cancer diagnosed after 40 years of age.

Women who had the BRCA1 mutation experienced the greatest risk reduction with weight loss (65%). The risk reduction was nonsignificant (22%) for those patients with the BRCA2 mutation.

Weight gain of more than 10 pounds also canceled out any protective effect of parity.

Gaining more than 10 pounds and having two full-term pregnancies was found to increase the risk of a woman having early-onset breast cancer by 44%, compared with those who gained minimal weight and who had at least two pregnancies.

About 40% of the women who lost 10 pounds or more had a body mass index of 25 kg/m

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A weight loss of at least 10 pounds will significantly decrease the risk of early-onset breast cancer in women who carry a BRCA mutation, according to results of a large case-control study.

Early-adulthood weight loss is especially important for women with the BRCA1 mutation. Among these women, the weight loss was associated with a 65% reduction in cancer risk, compared with a reference group of BRCA1 carriers, according to Joanne Kotsopoulos, a doctoral student at the University of Toronto, and her research colleagues (Breast Cancer Res. 2005;7:R833–43; doi 10.1186/bcr1293, online at breastcancerresearch.com/content/7/5/R833

The investigators examined early-onset breast cancer in 1,073 matched case-control pairs; about 75% had BRCA1 mutations and 25% had BRCA2 mutations.

Weight loss of at least 10 pounds between age 18 and 30 resulted in an overall 34% reduction in the risk of breast cancer. The risk reduction was greater (63%) for breast cancers diagnosed between ages 30 and 40, but not significant for breast cancer diagnosed after 40 years of age.

Women who had the BRCA1 mutation experienced the greatest risk reduction with weight loss (65%). The risk reduction was nonsignificant (22%) for those patients with the BRCA2 mutation.

Weight gain of more than 10 pounds also canceled out any protective effect of parity.

Gaining more than 10 pounds and having two full-term pregnancies was found to increase the risk of a woman having early-onset breast cancer by 44%, compared with those who gained minimal weight and who had at least two pregnancies.

About 40% of the women who lost 10 pounds or more had a body mass index of 25 kg/m

A weight loss of at least 10 pounds will significantly decrease the risk of early-onset breast cancer in women who carry a BRCA mutation, according to results of a large case-control study.

Early-adulthood weight loss is especially important for women with the BRCA1 mutation. Among these women, the weight loss was associated with a 65% reduction in cancer risk, compared with a reference group of BRCA1 carriers, according to Joanne Kotsopoulos, a doctoral student at the University of Toronto, and her research colleagues (Breast Cancer Res. 2005;7:R833–43; doi 10.1186/bcr1293, online at breastcancerresearch.com/content/7/5/R833

The investigators examined early-onset breast cancer in 1,073 matched case-control pairs; about 75% had BRCA1 mutations and 25% had BRCA2 mutations.

Weight loss of at least 10 pounds between age 18 and 30 resulted in an overall 34% reduction in the risk of breast cancer. The risk reduction was greater (63%) for breast cancers diagnosed between ages 30 and 40, but not significant for breast cancer diagnosed after 40 years of age.

Women who had the BRCA1 mutation experienced the greatest risk reduction with weight loss (65%). The risk reduction was nonsignificant (22%) for those patients with the BRCA2 mutation.

Weight gain of more than 10 pounds also canceled out any protective effect of parity.

Gaining more than 10 pounds and having two full-term pregnancies was found to increase the risk of a woman having early-onset breast cancer by 44%, compared with those who gained minimal weight and who had at least two pregnancies.

About 40% of the women who lost 10 pounds or more had a body mass index of 25 kg/m

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Screen-Detected Breast Ca Has Better Outcome

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Women whose breast cancers were detected by screening mammography were 53% less likely to die of breast cancer over a 10- to 15-year period than those whose cancers were detected symptomatically, Donald Berry, Ph.D., and his colleagues have reported.

The study of more than 150,000 women doesn't mean that screening mammography is beneficial, however, Dr. Berry told this newspaper. The real reason behind the survival shift, he said, is that mammography picks up tumors that grow more slowly and are less biologically lethal than those discovered symptomatically.

Dr. Berry, chairman of the department of biostatistics and applied mathematics at the University of Texas, Houston, and his coinvestigators examined survival outcomes in three large North American breast cancer screening trials containing about 152,000 women: the breast cancer screening trial of the Health Insurance Plan of Greater New York (HIP) and two Canadian National Breast Screening Studies (CNBSS-1 and CNBSS-2).

The HIP screening was carried out in the 1960s, while both CNBSS trials were conducted in the 1980s. Follow-up ranged from 15 to 20 years (J. Natl. Cancer Inst. 2005;97:1195–203).

The researchers looked at the occurrence of screen-detected cancers, cancers detected in control groups (no screening mammography), and interval/incident cancers (cancers detected either less than 1 year or more than 1 year after the last negative screen).

There was a clear shift toward earlier stage cancers in the screening groups. In the HIP trial, 76% of screen-detected cancers were stage I, compared with 51% of interval/incident cancers and 49% of cancers in the control group. Control subjects and women who failed to attend their screenings had the highest percentage of stage III/IV cancers—14% and 22%, respectively.

In the CNBSS-1, 55% of screen-tested cancers, 40% of interval/incident cancers, and 47% of cancers in the control group were stage I. In the CNBSS-2, 62% of the screen-detected cancers, 44% of the interval/incident cancers, and 47% of the cancers in the control group were stage I. In both trials, the highest percentage of stage III/IV cancers occurred in the interval/incident group (about 20%).

Tumor sizes were smaller in the screening groups in all three studies; there was a significantly higher proportion of negative lymph nodes among women with screen-detected cancers in all three studies.

These characteristics reflect lead-time bias, Dr. Berry said, and he adjusted the analysis to compensate for this. However, even after adjustment for tumor characteristics, women whose cancers were detected by screening had the longest survival time. The relative risk of breast cancer death was 53% greater for women with interval/incident cancers and 36% greater for those in the control group with cancer, than were those for women with screen-detected cancers.

The survival advantage seems to arise from the mammogram's tendency to detect less aggressive tumors, he said. “Cancers found via screening include a higher proportion of slowly growing tumors, some of which might never be found by other means.” Paradoxically, this “overdiagnosis bias” means that the study cannot answer the question of whether screening mammography is beneficial.

“In addition to detecting the lethal tumors, screening also detects some [tumors] of the nonlethal variety,” Dr. Berry said. Some women with screen-detected nonlethal tumors may receive unnecessary surgery or other treatment, he said.

The investigators noted several limitations of the study. Since all women were screened in either the 1960s and the 1980s, the trials not only used less sophisticated mammographic techniques, but they also did not reflect tumor grading with modern biomarkers or the improved treatment techniques that are available today.

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Women whose breast cancers were detected by screening mammography were 53% less likely to die of breast cancer over a 10- to 15-year period than those whose cancers were detected symptomatically, Donald Berry, Ph.D., and his colleagues have reported.

The study of more than 150,000 women doesn't mean that screening mammography is beneficial, however, Dr. Berry told this newspaper. The real reason behind the survival shift, he said, is that mammography picks up tumors that grow more slowly and are less biologically lethal than those discovered symptomatically.

Dr. Berry, chairman of the department of biostatistics and applied mathematics at the University of Texas, Houston, and his coinvestigators examined survival outcomes in three large North American breast cancer screening trials containing about 152,000 women: the breast cancer screening trial of the Health Insurance Plan of Greater New York (HIP) and two Canadian National Breast Screening Studies (CNBSS-1 and CNBSS-2).

The HIP screening was carried out in the 1960s, while both CNBSS trials were conducted in the 1980s. Follow-up ranged from 15 to 20 years (J. Natl. Cancer Inst. 2005;97:1195–203).

The researchers looked at the occurrence of screen-detected cancers, cancers detected in control groups (no screening mammography), and interval/incident cancers (cancers detected either less than 1 year or more than 1 year after the last negative screen).

There was a clear shift toward earlier stage cancers in the screening groups. In the HIP trial, 76% of screen-detected cancers were stage I, compared with 51% of interval/incident cancers and 49% of cancers in the control group. Control subjects and women who failed to attend their screenings had the highest percentage of stage III/IV cancers—14% and 22%, respectively.

In the CNBSS-1, 55% of screen-tested cancers, 40% of interval/incident cancers, and 47% of cancers in the control group were stage I. In the CNBSS-2, 62% of the screen-detected cancers, 44% of the interval/incident cancers, and 47% of the cancers in the control group were stage I. In both trials, the highest percentage of stage III/IV cancers occurred in the interval/incident group (about 20%).

Tumor sizes were smaller in the screening groups in all three studies; there was a significantly higher proportion of negative lymph nodes among women with screen-detected cancers in all three studies.

These characteristics reflect lead-time bias, Dr. Berry said, and he adjusted the analysis to compensate for this. However, even after adjustment for tumor characteristics, women whose cancers were detected by screening had the longest survival time. The relative risk of breast cancer death was 53% greater for women with interval/incident cancers and 36% greater for those in the control group with cancer, than were those for women with screen-detected cancers.

The survival advantage seems to arise from the mammogram's tendency to detect less aggressive tumors, he said. “Cancers found via screening include a higher proportion of slowly growing tumors, some of which might never be found by other means.” Paradoxically, this “overdiagnosis bias” means that the study cannot answer the question of whether screening mammography is beneficial.

“In addition to detecting the lethal tumors, screening also detects some [tumors] of the nonlethal variety,” Dr. Berry said. Some women with screen-detected nonlethal tumors may receive unnecessary surgery or other treatment, he said.

The investigators noted several limitations of the study. Since all women were screened in either the 1960s and the 1980s, the trials not only used less sophisticated mammographic techniques, but they also did not reflect tumor grading with modern biomarkers or the improved treatment techniques that are available today.

Women whose breast cancers were detected by screening mammography were 53% less likely to die of breast cancer over a 10- to 15-year period than those whose cancers were detected symptomatically, Donald Berry, Ph.D., and his colleagues have reported.

The study of more than 150,000 women doesn't mean that screening mammography is beneficial, however, Dr. Berry told this newspaper. The real reason behind the survival shift, he said, is that mammography picks up tumors that grow more slowly and are less biologically lethal than those discovered symptomatically.

Dr. Berry, chairman of the department of biostatistics and applied mathematics at the University of Texas, Houston, and his coinvestigators examined survival outcomes in three large North American breast cancer screening trials containing about 152,000 women: the breast cancer screening trial of the Health Insurance Plan of Greater New York (HIP) and two Canadian National Breast Screening Studies (CNBSS-1 and CNBSS-2).

The HIP screening was carried out in the 1960s, while both CNBSS trials were conducted in the 1980s. Follow-up ranged from 15 to 20 years (J. Natl. Cancer Inst. 2005;97:1195–203).

The researchers looked at the occurrence of screen-detected cancers, cancers detected in control groups (no screening mammography), and interval/incident cancers (cancers detected either less than 1 year or more than 1 year after the last negative screen).

There was a clear shift toward earlier stage cancers in the screening groups. In the HIP trial, 76% of screen-detected cancers were stage I, compared with 51% of interval/incident cancers and 49% of cancers in the control group. Control subjects and women who failed to attend their screenings had the highest percentage of stage III/IV cancers—14% and 22%, respectively.

In the CNBSS-1, 55% of screen-tested cancers, 40% of interval/incident cancers, and 47% of cancers in the control group were stage I. In the CNBSS-2, 62% of the screen-detected cancers, 44% of the interval/incident cancers, and 47% of the cancers in the control group were stage I. In both trials, the highest percentage of stage III/IV cancers occurred in the interval/incident group (about 20%).

Tumor sizes were smaller in the screening groups in all three studies; there was a significantly higher proportion of negative lymph nodes among women with screen-detected cancers in all three studies.

These characteristics reflect lead-time bias, Dr. Berry said, and he adjusted the analysis to compensate for this. However, even after adjustment for tumor characteristics, women whose cancers were detected by screening had the longest survival time. The relative risk of breast cancer death was 53% greater for women with interval/incident cancers and 36% greater for those in the control group with cancer, than were those for women with screen-detected cancers.

The survival advantage seems to arise from the mammogram's tendency to detect less aggressive tumors, he said. “Cancers found via screening include a higher proportion of slowly growing tumors, some of which might never be found by other means.” Paradoxically, this “overdiagnosis bias” means that the study cannot answer the question of whether screening mammography is beneficial.

“In addition to detecting the lethal tumors, screening also detects some [tumors] of the nonlethal variety,” Dr. Berry said. Some women with screen-detected nonlethal tumors may receive unnecessary surgery or other treatment, he said.

The investigators noted several limitations of the study. Since all women were screened in either the 1960s and the 1980s, the trials not only used less sophisticated mammographic techniques, but they also did not reflect tumor grading with modern biomarkers or the improved treatment techniques that are available today.

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Online PTSD Treatment Algorithm Makes Debut

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An interactive, online treatment algorithm provides a decision tree complete with graded supporting evidence and special clinical considerations for patients with posttraumatic stress disorder.

The new tool is a product of the International Psychopharmacology Algorithm Project, said Jonathan Davidson, M.D., chairman of the IPAP PTSD algorithm faculty. Last year, the group launched its online, interactive algorithm for diagnosing and treating schizophrenia. Both are free to registered users at www.ipap.com

“We hope the PTSD algorithm will be used both in the United States and internationally as a readily available” guide, Dr. Davidson said. “It presents clinicians with the types of problems they are likely to encounter with these patients and helps them identify where to start treatment and where to go next if treatment fails or if the patient is only partially responsive. It also lays out the evidence for those decisions.”

The algorithm is intended for use by mental health clinicians and primary care physicians who might be the first to suspect and diagnose PTSD in their patients. “It's very much aimed at people who are going to encounter these patients in general practice, and that includes all primary care physicians,” said Dr. Davidson, professor of psychiatry and behavioral science at Duke University, Durham, N.C.

The document exists online, so it has the fluidity to respond quickly to any research or new drug options that could alter treatment protocol, he added. As cochair of the committee that examined PTSD criteria for DSM-IV, Dr. Davidson appreciates that kind of flexibility. “You don't have to wait 2 years for a committee's suggestions to go through the bureaucracy.”

The algorithm begins with the initial decision after a diagnosis of PTSD—whether to offer psychosocial therapy, pharmacotherapy, or both. Psychosocial factors, such as the presence of suicidality, psychoses, nightmares, sleep disorder, and compliance, affect that decision.

It then explores initial medication choices along with appropriate dosages, calling for a minimum 4- to 6-week trial of a selective serotonin reuptake inhibitor or a selective norepinephrine reuptake inhibitor, or a tricyclic antidepressant if those choices are unavailable.

The algorithm really proves its usefulness after this node, he said, as it considers those patients who fail to respond or have only a partial response. “The question then is where to go. What do you do if, for example, the patients have continued nightmares?” Choices include increasing the dose or adding additional medications. If after several medication adjustments, there is still not adequate repose, the algorithm suggests reevaluating for another disorder and adding psychosocial therapy, as appropriate.

A click on any node in the algorithm takes the reader to notes containing literature references and grading the level of evidence upon which the decision node is based. Since it's also intended for use outside the U.S., all pharmacotherapy suggestions include alternative drugs that may be more available in other countries.

The algorithm is being translated into Spanish, Chinese, Japanese, and Thai. In fact, Dr. Davidson and coauthor Kathryn Connor, M.D., are preparing to visit Thailand to help train 100 physicians to recognize and treat PTSD, with the algorithm playing an important part.

Areas of Thailand that were hit by the tsunami are experiencing high rates of PTSD, Dr. Davidson said. “In the United States, the prevalence is about 6%, and that has stayed relatively stable for years. The prevalence is obviously tied up with prevalence of trauma in a community and whether there is support for the survivors and preservation of the community, both of which are important determinants.”

The PTSD algorithm was supported by grants from the Dean Foundation, a not-for-profit entity. The Dean Foundation accepts funds from pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Johnson & Johnson, Novartis, Pfizer, Forest, GlaxoSmithKline, UCB Pharma, and Wyeth-Ayerst.

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An interactive, online treatment algorithm provides a decision tree complete with graded supporting evidence and special clinical considerations for patients with posttraumatic stress disorder.

The new tool is a product of the International Psychopharmacology Algorithm Project, said Jonathan Davidson, M.D., chairman of the IPAP PTSD algorithm faculty. Last year, the group launched its online, interactive algorithm for diagnosing and treating schizophrenia. Both are free to registered users at www.ipap.com

“We hope the PTSD algorithm will be used both in the United States and internationally as a readily available” guide, Dr. Davidson said. “It presents clinicians with the types of problems they are likely to encounter with these patients and helps them identify where to start treatment and where to go next if treatment fails or if the patient is only partially responsive. It also lays out the evidence for those decisions.”

The algorithm is intended for use by mental health clinicians and primary care physicians who might be the first to suspect and diagnose PTSD in their patients. “It's very much aimed at people who are going to encounter these patients in general practice, and that includes all primary care physicians,” said Dr. Davidson, professor of psychiatry and behavioral science at Duke University, Durham, N.C.

The document exists online, so it has the fluidity to respond quickly to any research or new drug options that could alter treatment protocol, he added. As cochair of the committee that examined PTSD criteria for DSM-IV, Dr. Davidson appreciates that kind of flexibility. “You don't have to wait 2 years for a committee's suggestions to go through the bureaucracy.”

The algorithm begins with the initial decision after a diagnosis of PTSD—whether to offer psychosocial therapy, pharmacotherapy, or both. Psychosocial factors, such as the presence of suicidality, psychoses, nightmares, sleep disorder, and compliance, affect that decision.

It then explores initial medication choices along with appropriate dosages, calling for a minimum 4- to 6-week trial of a selective serotonin reuptake inhibitor or a selective norepinephrine reuptake inhibitor, or a tricyclic antidepressant if those choices are unavailable.

The algorithm really proves its usefulness after this node, he said, as it considers those patients who fail to respond or have only a partial response. “The question then is where to go. What do you do if, for example, the patients have continued nightmares?” Choices include increasing the dose or adding additional medications. If after several medication adjustments, there is still not adequate repose, the algorithm suggests reevaluating for another disorder and adding psychosocial therapy, as appropriate.

A click on any node in the algorithm takes the reader to notes containing literature references and grading the level of evidence upon which the decision node is based. Since it's also intended for use outside the U.S., all pharmacotherapy suggestions include alternative drugs that may be more available in other countries.

The algorithm is being translated into Spanish, Chinese, Japanese, and Thai. In fact, Dr. Davidson and coauthor Kathryn Connor, M.D., are preparing to visit Thailand to help train 100 physicians to recognize and treat PTSD, with the algorithm playing an important part.

Areas of Thailand that were hit by the tsunami are experiencing high rates of PTSD, Dr. Davidson said. “In the United States, the prevalence is about 6%, and that has stayed relatively stable for years. The prevalence is obviously tied up with prevalence of trauma in a community and whether there is support for the survivors and preservation of the community, both of which are important determinants.”

The PTSD algorithm was supported by grants from the Dean Foundation, a not-for-profit entity. The Dean Foundation accepts funds from pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Johnson & Johnson, Novartis, Pfizer, Forest, GlaxoSmithKline, UCB Pharma, and Wyeth-Ayerst.

An interactive, online treatment algorithm provides a decision tree complete with graded supporting evidence and special clinical considerations for patients with posttraumatic stress disorder.

The new tool is a product of the International Psychopharmacology Algorithm Project, said Jonathan Davidson, M.D., chairman of the IPAP PTSD algorithm faculty. Last year, the group launched its online, interactive algorithm for diagnosing and treating schizophrenia. Both are free to registered users at www.ipap.com

“We hope the PTSD algorithm will be used both in the United States and internationally as a readily available” guide, Dr. Davidson said. “It presents clinicians with the types of problems they are likely to encounter with these patients and helps them identify where to start treatment and where to go next if treatment fails or if the patient is only partially responsive. It also lays out the evidence for those decisions.”

The algorithm is intended for use by mental health clinicians and primary care physicians who might be the first to suspect and diagnose PTSD in their patients. “It's very much aimed at people who are going to encounter these patients in general practice, and that includes all primary care physicians,” said Dr. Davidson, professor of psychiatry and behavioral science at Duke University, Durham, N.C.

The document exists online, so it has the fluidity to respond quickly to any research or new drug options that could alter treatment protocol, he added. As cochair of the committee that examined PTSD criteria for DSM-IV, Dr. Davidson appreciates that kind of flexibility. “You don't have to wait 2 years for a committee's suggestions to go through the bureaucracy.”

The algorithm begins with the initial decision after a diagnosis of PTSD—whether to offer psychosocial therapy, pharmacotherapy, or both. Psychosocial factors, such as the presence of suicidality, psychoses, nightmares, sleep disorder, and compliance, affect that decision.

It then explores initial medication choices along with appropriate dosages, calling for a minimum 4- to 6-week trial of a selective serotonin reuptake inhibitor or a selective norepinephrine reuptake inhibitor, or a tricyclic antidepressant if those choices are unavailable.

The algorithm really proves its usefulness after this node, he said, as it considers those patients who fail to respond or have only a partial response. “The question then is where to go. What do you do if, for example, the patients have continued nightmares?” Choices include increasing the dose or adding additional medications. If after several medication adjustments, there is still not adequate repose, the algorithm suggests reevaluating for another disorder and adding psychosocial therapy, as appropriate.

A click on any node in the algorithm takes the reader to notes containing literature references and grading the level of evidence upon which the decision node is based. Since it's also intended for use outside the U.S., all pharmacotherapy suggestions include alternative drugs that may be more available in other countries.

The algorithm is being translated into Spanish, Chinese, Japanese, and Thai. In fact, Dr. Davidson and coauthor Kathryn Connor, M.D., are preparing to visit Thailand to help train 100 physicians to recognize and treat PTSD, with the algorithm playing an important part.

Areas of Thailand that were hit by the tsunami are experiencing high rates of PTSD, Dr. Davidson said. “In the United States, the prevalence is about 6%, and that has stayed relatively stable for years. The prevalence is obviously tied up with prevalence of trauma in a community and whether there is support for the survivors and preservation of the community, both of which are important determinants.”

The PTSD algorithm was supported by grants from the Dean Foundation, a not-for-profit entity. The Dean Foundation accepts funds from pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Johnson & Johnson, Novartis, Pfizer, Forest, GlaxoSmithKline, UCB Pharma, and Wyeth-Ayerst.

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Gatifloxacin Found Safe, Effective for Otitis Media

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Gatifloxacin appears to be both safe and highly effective in treating acute and recurrent otitis media in children, and is not associated with either acute or long-term joint disorders, Michael Pichichero, M.D., and his colleagues reported.

In the compilation of four clinical trials (two phase II and two phase III), they also concluded that the drug, a fluoroquinolone, was more effective in eradicating middle-ear pathogens than was amoxicillin/clavulanate.

The effect of a 10-day course of gatifloxacin (10 mg/kg per day) was evaluated in 867 children aged 6 months to 7 years. The phase III trials also included 309 children who received amoxicillin/clavulanate as a comparator.

All children had acute otitis media (OM), recurrent OM, or OM treatment failure (Clin. Infect. Dis. 2005;41:470–8).

In the phase II trials (414 children), the high rate of discontinuation (8%) was primarily due to vomiting because of the bitter taste of an early formulation of the drug, said Dr. Pichichero of the University of Rochester (N.Y.) and his coinvestigators. In the phase III studies, with a new formulation, the rate of discontinuation was similar in both groups (2%).

Transient arthralgia occurred in 12 (1.4%) of the 867 children. There were no abnormal imaging studies in any of the 7 who were examined by an orthopedist. One child discontinued therapy due to knee swelling and abnormal gait; no joint abnormalities were seen on imaging.

In the phase III studies, the rate of arthralgia was similar between the gatifloxacin and amoxicillin/clavulanate groups (1.5% and 1.3%).

One-year safety data were available for 671 gatifloxacin-treated children. There was no evidence of arthropathy in any. A 4-year-old girl treated with the study drug developed Achilles tendon pain, which resolved in 5 days with rest and ice.

Gatifloxacin was not associated with hepatotoxicity, clinically relevant hypoglycemia, phototoxicity, or central nervous system toxicity.

The cure rate of the pooled phase II studies was 81%. In the first phase III study, the cure rate of gatifloxacin was 90%, compared with 84% for amoxicillin/clavulanate. The cure rate for gatifloxacin in the second phase II study was 85%, compared with 79% for amoxicillin/clavulanate.

The study drug was especially effective in children younger than 2 years with severe acute otitis media; the cure rate was 90%, compared with 75% for the amoxicillin regimen. Gatifloxacin eradicated both Streptococcus pneumoniae and Haemophilus influenzae. It achieved highly significant clinical cure rates for pathogens that were resistant to one or two other antibiotics.

Pediatric use of gatifloxacin remains controversial, not only because of concerns about arthropathy, but also because childhood resistance could impact the drug's usefulness in future adult populations, the authors noted.

However, in an accompanying editorial, Colin Marchant, M.D., said the drug deserves a chance.

Promising trial results, scheduled for discussion at a May 2004 meeting of the Food and Drug Administration's Anti-Infective Drugs Advisory Committee, were scrapped at the last minute when Bristol-Myers Squibb, the drug's manufacturer, abruptly withdrew its new drug application. The stated reason was that the drug company and the FDA could not agree on a risk-management program for the drug, said Dr. Marchant of the Boston Medical Center (Clin. Infect. Dis. 2005;41:479–80).

“The safety data on gatifloxacin use in children should be reviewed in a public forum [such as the committee],” he said. “If there are no data indicating increased risks of side effects with gatifloxacin … then recommendations for further safety studies should be put forward; and the nature and basis for a risk-management program should also be exposed to public scrutiny and discussion.”

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Gatifloxacin appears to be both safe and highly effective in treating acute and recurrent otitis media in children, and is not associated with either acute or long-term joint disorders, Michael Pichichero, M.D., and his colleagues reported.

In the compilation of four clinical trials (two phase II and two phase III), they also concluded that the drug, a fluoroquinolone, was more effective in eradicating middle-ear pathogens than was amoxicillin/clavulanate.

The effect of a 10-day course of gatifloxacin (10 mg/kg per day) was evaluated in 867 children aged 6 months to 7 years. The phase III trials also included 309 children who received amoxicillin/clavulanate as a comparator.

All children had acute otitis media (OM), recurrent OM, or OM treatment failure (Clin. Infect. Dis. 2005;41:470–8).

In the phase II trials (414 children), the high rate of discontinuation (8%) was primarily due to vomiting because of the bitter taste of an early formulation of the drug, said Dr. Pichichero of the University of Rochester (N.Y.) and his coinvestigators. In the phase III studies, with a new formulation, the rate of discontinuation was similar in both groups (2%).

Transient arthralgia occurred in 12 (1.4%) of the 867 children. There were no abnormal imaging studies in any of the 7 who were examined by an orthopedist. One child discontinued therapy due to knee swelling and abnormal gait; no joint abnormalities were seen on imaging.

In the phase III studies, the rate of arthralgia was similar between the gatifloxacin and amoxicillin/clavulanate groups (1.5% and 1.3%).

One-year safety data were available for 671 gatifloxacin-treated children. There was no evidence of arthropathy in any. A 4-year-old girl treated with the study drug developed Achilles tendon pain, which resolved in 5 days with rest and ice.

Gatifloxacin was not associated with hepatotoxicity, clinically relevant hypoglycemia, phototoxicity, or central nervous system toxicity.

The cure rate of the pooled phase II studies was 81%. In the first phase III study, the cure rate of gatifloxacin was 90%, compared with 84% for amoxicillin/clavulanate. The cure rate for gatifloxacin in the second phase II study was 85%, compared with 79% for amoxicillin/clavulanate.

The study drug was especially effective in children younger than 2 years with severe acute otitis media; the cure rate was 90%, compared with 75% for the amoxicillin regimen. Gatifloxacin eradicated both Streptococcus pneumoniae and Haemophilus influenzae. It achieved highly significant clinical cure rates for pathogens that were resistant to one or two other antibiotics.

Pediatric use of gatifloxacin remains controversial, not only because of concerns about arthropathy, but also because childhood resistance could impact the drug's usefulness in future adult populations, the authors noted.

However, in an accompanying editorial, Colin Marchant, M.D., said the drug deserves a chance.

Promising trial results, scheduled for discussion at a May 2004 meeting of the Food and Drug Administration's Anti-Infective Drugs Advisory Committee, were scrapped at the last minute when Bristol-Myers Squibb, the drug's manufacturer, abruptly withdrew its new drug application. The stated reason was that the drug company and the FDA could not agree on a risk-management program for the drug, said Dr. Marchant of the Boston Medical Center (Clin. Infect. Dis. 2005;41:479–80).

“The safety data on gatifloxacin use in children should be reviewed in a public forum [such as the committee],” he said. “If there are no data indicating increased risks of side effects with gatifloxacin … then recommendations for further safety studies should be put forward; and the nature and basis for a risk-management program should also be exposed to public scrutiny and discussion.”

Gatifloxacin appears to be both safe and highly effective in treating acute and recurrent otitis media in children, and is not associated with either acute or long-term joint disorders, Michael Pichichero, M.D., and his colleagues reported.

In the compilation of four clinical trials (two phase II and two phase III), they also concluded that the drug, a fluoroquinolone, was more effective in eradicating middle-ear pathogens than was amoxicillin/clavulanate.

The effect of a 10-day course of gatifloxacin (10 mg/kg per day) was evaluated in 867 children aged 6 months to 7 years. The phase III trials also included 309 children who received amoxicillin/clavulanate as a comparator.

All children had acute otitis media (OM), recurrent OM, or OM treatment failure (Clin. Infect. Dis. 2005;41:470–8).

In the phase II trials (414 children), the high rate of discontinuation (8%) was primarily due to vomiting because of the bitter taste of an early formulation of the drug, said Dr. Pichichero of the University of Rochester (N.Y.) and his coinvestigators. In the phase III studies, with a new formulation, the rate of discontinuation was similar in both groups (2%).

Transient arthralgia occurred in 12 (1.4%) of the 867 children. There were no abnormal imaging studies in any of the 7 who were examined by an orthopedist. One child discontinued therapy due to knee swelling and abnormal gait; no joint abnormalities were seen on imaging.

In the phase III studies, the rate of arthralgia was similar between the gatifloxacin and amoxicillin/clavulanate groups (1.5% and 1.3%).

One-year safety data were available for 671 gatifloxacin-treated children. There was no evidence of arthropathy in any. A 4-year-old girl treated with the study drug developed Achilles tendon pain, which resolved in 5 days with rest and ice.

Gatifloxacin was not associated with hepatotoxicity, clinically relevant hypoglycemia, phototoxicity, or central nervous system toxicity.

The cure rate of the pooled phase II studies was 81%. In the first phase III study, the cure rate of gatifloxacin was 90%, compared with 84% for amoxicillin/clavulanate. The cure rate for gatifloxacin in the second phase II study was 85%, compared with 79% for amoxicillin/clavulanate.

The study drug was especially effective in children younger than 2 years with severe acute otitis media; the cure rate was 90%, compared with 75% for the amoxicillin regimen. Gatifloxacin eradicated both Streptococcus pneumoniae and Haemophilus influenzae. It achieved highly significant clinical cure rates for pathogens that were resistant to one or two other antibiotics.

Pediatric use of gatifloxacin remains controversial, not only because of concerns about arthropathy, but also because childhood resistance could impact the drug's usefulness in future adult populations, the authors noted.

However, in an accompanying editorial, Colin Marchant, M.D., said the drug deserves a chance.

Promising trial results, scheduled for discussion at a May 2004 meeting of the Food and Drug Administration's Anti-Infective Drugs Advisory Committee, were scrapped at the last minute when Bristol-Myers Squibb, the drug's manufacturer, abruptly withdrew its new drug application. The stated reason was that the drug company and the FDA could not agree on a risk-management program for the drug, said Dr. Marchant of the Boston Medical Center (Clin. Infect. Dis. 2005;41:479–80).

“The safety data on gatifloxacin use in children should be reviewed in a public forum [such as the committee],” he said. “If there are no data indicating increased risks of side effects with gatifloxacin … then recommendations for further safety studies should be put forward; and the nature and basis for a risk-management program should also be exposed to public scrutiny and discussion.”

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Bone Drugs Underused By Oral Steroid Patients

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ST. LOUIS — Bisphosphonates remain underutilized in the prevention of glucocorticoid-induced osteoporosis, despite national clinical guidelines that recommend their use in patients on long-term oral steroid therapy, Rosemarie Liu, M.D., said at the annual meeting of the Society of Investigative Dermatology.

“In 2001, the American College of Rheumatology published guidelines recommending that all patients beginning long-term oral steroid therapy of at least 5 mg/day should receive a prescription for a bisphosphonate, if not contraindicated,” said Dr. Liu of Eastern Virginia Medical School, Norfolk. “Despite these guidelines, the vast majority of patients in our study did not receive appropriate prophylaxis for glucocorticoid-induced osteoporosis (GIOP).”

In fact, she said, her study showed that the guidelines had no effect at all on the number of patients who received the bone-protective drugs.

Dr. Liu and her colleagues conducted a cross-sectional study of 35 patients referred to the tertiary dermatology clinic at the Hospital of the University of Pennsylvania, Philadelphia, from 1995 to 2004. Of that group, 60% (21) were female and 83% (29) were white. Their mean age was 54 years (29–86). The mean daily dose of prednisone was 53 mg, with a range of 10–150 mg/day. The patients had been on steroids for a mean of 17 months, with the longest duration of use, 102 months.

Twenty-eight (80%) of the patients were taking prednisone for pemphigus vulgaris; other indications were lupus erythematosus, (4), dermatomyositis (2), and arthritis with interstitial granulomatous dermatitis (1).

The majority of the patients (80%) were not on any bisphosphonates at the time of their referral. The investigators found that the 2001 publication of the ACR Guidelines for Prevention and Treatment of Glucocorticoid-Induced Osteoporosis had no effect on bisphosphonate prescriptions in this group.

“The guidelines were published in July 2001, but we used January 2002 as the cut-off date, because we wanted to give adequate time for them to be incorporated into clinical practice,” Dr. Liu said. Among those referred before 2002, 75% were not on bisphosphonates; among these referred after 2002 (1 year after the guidelines were published), 81% were not on bisphosphonates.

Among the eight patients who were on the drug before referral, seven were taking it specifically for GIOP, and one had been previously diagnosed with osteoporosis.

Dual-energy x-ray absorptiometry scans were available for 18 of the patients. The mean time on steroids before DXA scan was 13 months. Seven of those patients had a normal scan, eight had evidence of osteopenia, and three had evidence of osteoporosis. One patient developed a vertebral fracture within 5 months of beginning prednisone.

“Clinicians should be aware of the ACR guidelines,” Dr. Liu said. “When patients are started on long-term oral steroids, a bisphosphonate should be prescribed unless contraindicated. Also, a baseline DXA scan should be ordered to provide information about baseline bone health, and should be repeated whenever clinically indicated.”

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ST. LOUIS — Bisphosphonates remain underutilized in the prevention of glucocorticoid-induced osteoporosis, despite national clinical guidelines that recommend their use in patients on long-term oral steroid therapy, Rosemarie Liu, M.D., said at the annual meeting of the Society of Investigative Dermatology.

“In 2001, the American College of Rheumatology published guidelines recommending that all patients beginning long-term oral steroid therapy of at least 5 mg/day should receive a prescription for a bisphosphonate, if not contraindicated,” said Dr. Liu of Eastern Virginia Medical School, Norfolk. “Despite these guidelines, the vast majority of patients in our study did not receive appropriate prophylaxis for glucocorticoid-induced osteoporosis (GIOP).”

In fact, she said, her study showed that the guidelines had no effect at all on the number of patients who received the bone-protective drugs.

Dr. Liu and her colleagues conducted a cross-sectional study of 35 patients referred to the tertiary dermatology clinic at the Hospital of the University of Pennsylvania, Philadelphia, from 1995 to 2004. Of that group, 60% (21) were female and 83% (29) were white. Their mean age was 54 years (29–86). The mean daily dose of prednisone was 53 mg, with a range of 10–150 mg/day. The patients had been on steroids for a mean of 17 months, with the longest duration of use, 102 months.

Twenty-eight (80%) of the patients were taking prednisone for pemphigus vulgaris; other indications were lupus erythematosus, (4), dermatomyositis (2), and arthritis with interstitial granulomatous dermatitis (1).

The majority of the patients (80%) were not on any bisphosphonates at the time of their referral. The investigators found that the 2001 publication of the ACR Guidelines for Prevention and Treatment of Glucocorticoid-Induced Osteoporosis had no effect on bisphosphonate prescriptions in this group.

“The guidelines were published in July 2001, but we used January 2002 as the cut-off date, because we wanted to give adequate time for them to be incorporated into clinical practice,” Dr. Liu said. Among those referred before 2002, 75% were not on bisphosphonates; among these referred after 2002 (1 year after the guidelines were published), 81% were not on bisphosphonates.

Among the eight patients who were on the drug before referral, seven were taking it specifically for GIOP, and one had been previously diagnosed with osteoporosis.

Dual-energy x-ray absorptiometry scans were available for 18 of the patients. The mean time on steroids before DXA scan was 13 months. Seven of those patients had a normal scan, eight had evidence of osteopenia, and three had evidence of osteoporosis. One patient developed a vertebral fracture within 5 months of beginning prednisone.

“Clinicians should be aware of the ACR guidelines,” Dr. Liu said. “When patients are started on long-term oral steroids, a bisphosphonate should be prescribed unless contraindicated. Also, a baseline DXA scan should be ordered to provide information about baseline bone health, and should be repeated whenever clinically indicated.”

ST. LOUIS — Bisphosphonates remain underutilized in the prevention of glucocorticoid-induced osteoporosis, despite national clinical guidelines that recommend their use in patients on long-term oral steroid therapy, Rosemarie Liu, M.D., said at the annual meeting of the Society of Investigative Dermatology.

“In 2001, the American College of Rheumatology published guidelines recommending that all patients beginning long-term oral steroid therapy of at least 5 mg/day should receive a prescription for a bisphosphonate, if not contraindicated,” said Dr. Liu of Eastern Virginia Medical School, Norfolk. “Despite these guidelines, the vast majority of patients in our study did not receive appropriate prophylaxis for glucocorticoid-induced osteoporosis (GIOP).”

In fact, she said, her study showed that the guidelines had no effect at all on the number of patients who received the bone-protective drugs.

Dr. Liu and her colleagues conducted a cross-sectional study of 35 patients referred to the tertiary dermatology clinic at the Hospital of the University of Pennsylvania, Philadelphia, from 1995 to 2004. Of that group, 60% (21) were female and 83% (29) were white. Their mean age was 54 years (29–86). The mean daily dose of prednisone was 53 mg, with a range of 10–150 mg/day. The patients had been on steroids for a mean of 17 months, with the longest duration of use, 102 months.

Twenty-eight (80%) of the patients were taking prednisone for pemphigus vulgaris; other indications were lupus erythematosus, (4), dermatomyositis (2), and arthritis with interstitial granulomatous dermatitis (1).

The majority of the patients (80%) were not on any bisphosphonates at the time of their referral. The investigators found that the 2001 publication of the ACR Guidelines for Prevention and Treatment of Glucocorticoid-Induced Osteoporosis had no effect on bisphosphonate prescriptions in this group.

“The guidelines were published in July 2001, but we used January 2002 as the cut-off date, because we wanted to give adequate time for them to be incorporated into clinical practice,” Dr. Liu said. Among those referred before 2002, 75% were not on bisphosphonates; among these referred after 2002 (1 year after the guidelines were published), 81% were not on bisphosphonates.

Among the eight patients who were on the drug before referral, seven were taking it specifically for GIOP, and one had been previously diagnosed with osteoporosis.

Dual-energy x-ray absorptiometry scans were available for 18 of the patients. The mean time on steroids before DXA scan was 13 months. Seven of those patients had a normal scan, eight had evidence of osteopenia, and three had evidence of osteoporosis. One patient developed a vertebral fracture within 5 months of beginning prednisone.

“Clinicians should be aware of the ACR guidelines,” Dr. Liu said. “When patients are started on long-term oral steroids, a bisphosphonate should be prescribed unless contraindicated. Also, a baseline DXA scan should be ordered to provide information about baseline bone health, and should be repeated whenever clinically indicated.”

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Aerobic Fitness Decreases All-Cause Mortality in Hypertensive Women

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Aerobic Fitness Decreases All-Cause Mortality in Hypertensive Women

NASHVILLE, TENN. — Higher cardiorespiratory fitness is associated with lower all-cause mortality in hypertensive women, Carolyn E. Barlow said in a poster presented at the annual meeting of the American College of Sports Medicine.

Ms. Barlow, director of data management at the Cooper Institute, Dallas, presented the results of an open cohort study of almost 13,000 women who were followed for up to 26 years. The women were part of the Cooper Aerobics Center Longitudinal Study, a prospective observational study of lifestyle and health.

All the women were examined at the Cooper Aerobics Center in Dallas from 1971 to 1998, and followed up yearly for mortality.

At baseline, the women received a comprehensive medical examination and exercise prescription. They also took a treadmill test, which was used to determine their fitness level. The lowest 20% in each age group were considered “unfit,” while the upper 80% in each age group were considered “fit.”

At baseline, their average age was 43 years. Of the cohort, 51% were normotensive, 31% were prehypertensive (120/80 mm Hg), and 18% were hypertensive (140/90 mm Hg or higher).

There were 298 deaths during the study period. After adjustment for age, exam year, and smoking, a trend toward lower mortality risk was seen in fit women, compared with unfit women in each blood pressure group, but only in the hypertensive group was the difference statistically significant. Fit hypertensive women were 54% less likely to die than unfit hypertensive women.

The decreased risk of death was 19% for normotensive fit women, compared with unfit ones, and 5% for prehypertensive fit women, compared with those who were unfit.

“We've shown a similarly decreased risk for hypertensive men,” Ms. Barlow said.

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NASHVILLE, TENN. — Higher cardiorespiratory fitness is associated with lower all-cause mortality in hypertensive women, Carolyn E. Barlow said in a poster presented at the annual meeting of the American College of Sports Medicine.

Ms. Barlow, director of data management at the Cooper Institute, Dallas, presented the results of an open cohort study of almost 13,000 women who were followed for up to 26 years. The women were part of the Cooper Aerobics Center Longitudinal Study, a prospective observational study of lifestyle and health.

All the women were examined at the Cooper Aerobics Center in Dallas from 1971 to 1998, and followed up yearly for mortality.

At baseline, the women received a comprehensive medical examination and exercise prescription. They also took a treadmill test, which was used to determine their fitness level. The lowest 20% in each age group were considered “unfit,” while the upper 80% in each age group were considered “fit.”

At baseline, their average age was 43 years. Of the cohort, 51% were normotensive, 31% were prehypertensive (120/80 mm Hg), and 18% were hypertensive (140/90 mm Hg or higher).

There were 298 deaths during the study period. After adjustment for age, exam year, and smoking, a trend toward lower mortality risk was seen in fit women, compared with unfit women in each blood pressure group, but only in the hypertensive group was the difference statistically significant. Fit hypertensive women were 54% less likely to die than unfit hypertensive women.

The decreased risk of death was 19% for normotensive fit women, compared with unfit ones, and 5% for prehypertensive fit women, compared with those who were unfit.

“We've shown a similarly decreased risk for hypertensive men,” Ms. Barlow said.

NASHVILLE, TENN. — Higher cardiorespiratory fitness is associated with lower all-cause mortality in hypertensive women, Carolyn E. Barlow said in a poster presented at the annual meeting of the American College of Sports Medicine.

Ms. Barlow, director of data management at the Cooper Institute, Dallas, presented the results of an open cohort study of almost 13,000 women who were followed for up to 26 years. The women were part of the Cooper Aerobics Center Longitudinal Study, a prospective observational study of lifestyle and health.

All the women were examined at the Cooper Aerobics Center in Dallas from 1971 to 1998, and followed up yearly for mortality.

At baseline, the women received a comprehensive medical examination and exercise prescription. They also took a treadmill test, which was used to determine their fitness level. The lowest 20% in each age group were considered “unfit,” while the upper 80% in each age group were considered “fit.”

At baseline, their average age was 43 years. Of the cohort, 51% were normotensive, 31% were prehypertensive (120/80 mm Hg), and 18% were hypertensive (140/90 mm Hg or higher).

There were 298 deaths during the study period. After adjustment for age, exam year, and smoking, a trend toward lower mortality risk was seen in fit women, compared with unfit women in each blood pressure group, but only in the hypertensive group was the difference statistically significant. Fit hypertensive women were 54% less likely to die than unfit hypertensive women.

The decreased risk of death was 19% for normotensive fit women, compared with unfit ones, and 5% for prehypertensive fit women, compared with those who were unfit.

“We've shown a similarly decreased risk for hypertensive men,” Ms. Barlow said.

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New Guidelines Tackle Postsurgical Atrial Fib

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β-Blockers should be the first choice to control both rhythm and rate in patients experiencing atrial fibrillation after cardiac surgery; the drug class is also useful for preventing postoperative atrial fibrillation, according to new clinical practice guidelines issued by the American College of Chest Physicians.

The drugs' value stems from their antiadrenergic effect, said Peter McKeown, M.B., a member of the panel that authored the guidelines. “This counteracts the proadrenergic state patients experience after surgery, which can lead to atrial fibrillation,” he said. Bolstering the recommendation is the fact that many cardiac surgery patients are already on the drugs, which should not be discontinued before surgery.

“We should be putting them on β-blockers if they're not already on them, and keeping them on if they are,” Dr. McKeown said in an interview.

The panel, which included members of ACCP, the American College of Cardiology, the American College of Surgeons, the Society of Thoracic Surgeons, and the Society of Cardiovascular Anesthesiologists, also concluded that digoxin is contraindicated in these patients because it heightens postoperative adrenergic tone (Chest 2005;128:S1–S64).

Amiodarone was recommended for controlling rhythm in patients with postoperative AF and depressed left ventricular function, added Dr. McKeown of Duke University, Durham, N.C.

“A lot of the other drugs you hear about were not recommended because of their potential for rhythm disturbances, or because they are not suitable for patients with coronary artery disease,” he said.

The new guidelines were deemed necessary because existing guidelines don't focus on atrial fibrillation (AF) in postcardiac surgery patients, said Eric Prystowsky, M.D., a panel member and director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital, Indianapolis.

“The AF that occurs after cardiac surgery is really a unique problem that should be looked at differently than other AF issues,” he said in an interview. “It's a situation that has a temporal relationship to a very specific event, and should not be viewed as an ongoing event.”

Because of its acute nature and its common occurrence—up to 60% of cardiac surgery patients experience it—many patients leave the hospital either over- or undertreated, said Dr. Prystowsky, who also coauthored the 2001 American College of Cardiology/American Heart Association/European Society of Cardiology Guidelines for the Management of Patients With Atrial Fibrillation (J. Am. Coll. Cardiol. 2001;38:1231–66).

“If these patients fit a high-risk pattern for stroke, and many cardiac surgery patients do, then they are at a significantly increased risk if they develop AF. Many of them go home inappropriately anticoagulated. But it's not necessary for the rest of their lives. After they get back into normal rhythm, they can go back to their previous treatment regimen.”

The obsession with immediate restoration of normal heart rhythm has led to overtreatment, he added. “People are overaggressively focused on putting the rhythm back to normal acutely.”

“You don't have to give all kinds of drugs with potential toxicity. We have to remember this is an acute situation. It's perfectly acceptable to control the rate, make sure they're appropriately anticoagulated, and then let them regroup. The majority are back in normal rhythm by their 6-week checkup,” explained Dr. Prystowsky.

In constructing its recommendations, the panel conducted a comprehensive literature review that included 128 controlled trials; the evidence from each trial was graded, as were each of the subsequent recommendations.

“We looked for studies that could give answers to four goals for these patients,” Dr. McKeown said: “controlling ventricular response rate in AF, preventing thromboembolism, converting to normal sinus rhythm, and prophylaxis to prevent AF in this population.”

The panel found conflicting data on anticoagulation therapy for postoperative AF; therefore its recommendations in this area were based on expert opinion. However, the panel did recommend anticoagulation therapy in optimally selected patients with chronic AF and in those patients in whom it is likely that AF will continue.

For patients with chronic AF, the panel recommended postoperative warfarin, giving the recommendation an “A” grade, and saying the net benefit was substantial. For those with postoperative AF, the panel recommended postoperative heparin. The recommendation received a grade of “C,” with an intermediate net benefit.

The panel found no strong evidence as to duration of anticoagulation but said physicians should take into consideration the self-limiting nature of postoperative AF.

Studies comparing rates of atrial fibrillation in off-pump vs. on-pump coronary artery bypass graft procedures yielded conflicting results, the panel said. Therefore, it could not recommend off-pump procedures as a method of reducing postoperative AF.

Biatrial pacing after surgery was found to be effective in reducing the incidence of AF, and received a “B” grade, although evidence shows that the net benefit is probably small. Inconclusive evidence precluded the recommendation of isolated left or right atrial pacing.

 

 

The guidelines are meant to be just that—guidelines, Dr. McKeown said. “Evidence-based medicine gives you a rational way to treat people, but it's just one more piece of information you have to incorporate into the mix. It's still an individual choice that the physician must make based on the needs of the individual patient.”

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β-Blockers should be the first choice to control both rhythm and rate in patients experiencing atrial fibrillation after cardiac surgery; the drug class is also useful for preventing postoperative atrial fibrillation, according to new clinical practice guidelines issued by the American College of Chest Physicians.

The drugs' value stems from their antiadrenergic effect, said Peter McKeown, M.B., a member of the panel that authored the guidelines. “This counteracts the proadrenergic state patients experience after surgery, which can lead to atrial fibrillation,” he said. Bolstering the recommendation is the fact that many cardiac surgery patients are already on the drugs, which should not be discontinued before surgery.

“We should be putting them on β-blockers if they're not already on them, and keeping them on if they are,” Dr. McKeown said in an interview.

The panel, which included members of ACCP, the American College of Cardiology, the American College of Surgeons, the Society of Thoracic Surgeons, and the Society of Cardiovascular Anesthesiologists, also concluded that digoxin is contraindicated in these patients because it heightens postoperative adrenergic tone (Chest 2005;128:S1–S64).

Amiodarone was recommended for controlling rhythm in patients with postoperative AF and depressed left ventricular function, added Dr. McKeown of Duke University, Durham, N.C.

“A lot of the other drugs you hear about were not recommended because of their potential for rhythm disturbances, or because they are not suitable for patients with coronary artery disease,” he said.

The new guidelines were deemed necessary because existing guidelines don't focus on atrial fibrillation (AF) in postcardiac surgery patients, said Eric Prystowsky, M.D., a panel member and director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital, Indianapolis.

“The AF that occurs after cardiac surgery is really a unique problem that should be looked at differently than other AF issues,” he said in an interview. “It's a situation that has a temporal relationship to a very specific event, and should not be viewed as an ongoing event.”

Because of its acute nature and its common occurrence—up to 60% of cardiac surgery patients experience it—many patients leave the hospital either over- or undertreated, said Dr. Prystowsky, who also coauthored the 2001 American College of Cardiology/American Heart Association/European Society of Cardiology Guidelines for the Management of Patients With Atrial Fibrillation (J. Am. Coll. Cardiol. 2001;38:1231–66).

“If these patients fit a high-risk pattern for stroke, and many cardiac surgery patients do, then they are at a significantly increased risk if they develop AF. Many of them go home inappropriately anticoagulated. But it's not necessary for the rest of their lives. After they get back into normal rhythm, they can go back to their previous treatment regimen.”

The obsession with immediate restoration of normal heart rhythm has led to overtreatment, he added. “People are overaggressively focused on putting the rhythm back to normal acutely.”

“You don't have to give all kinds of drugs with potential toxicity. We have to remember this is an acute situation. It's perfectly acceptable to control the rate, make sure they're appropriately anticoagulated, and then let them regroup. The majority are back in normal rhythm by their 6-week checkup,” explained Dr. Prystowsky.

In constructing its recommendations, the panel conducted a comprehensive literature review that included 128 controlled trials; the evidence from each trial was graded, as were each of the subsequent recommendations.

“We looked for studies that could give answers to four goals for these patients,” Dr. McKeown said: “controlling ventricular response rate in AF, preventing thromboembolism, converting to normal sinus rhythm, and prophylaxis to prevent AF in this population.”

The panel found conflicting data on anticoagulation therapy for postoperative AF; therefore its recommendations in this area were based on expert opinion. However, the panel did recommend anticoagulation therapy in optimally selected patients with chronic AF and in those patients in whom it is likely that AF will continue.

For patients with chronic AF, the panel recommended postoperative warfarin, giving the recommendation an “A” grade, and saying the net benefit was substantial. For those with postoperative AF, the panel recommended postoperative heparin. The recommendation received a grade of “C,” with an intermediate net benefit.

The panel found no strong evidence as to duration of anticoagulation but said physicians should take into consideration the self-limiting nature of postoperative AF.

Studies comparing rates of atrial fibrillation in off-pump vs. on-pump coronary artery bypass graft procedures yielded conflicting results, the panel said. Therefore, it could not recommend off-pump procedures as a method of reducing postoperative AF.

Biatrial pacing after surgery was found to be effective in reducing the incidence of AF, and received a “B” grade, although evidence shows that the net benefit is probably small. Inconclusive evidence precluded the recommendation of isolated left or right atrial pacing.

 

 

The guidelines are meant to be just that—guidelines, Dr. McKeown said. “Evidence-based medicine gives you a rational way to treat people, but it's just one more piece of information you have to incorporate into the mix. It's still an individual choice that the physician must make based on the needs of the individual patient.”

β-Blockers should be the first choice to control both rhythm and rate in patients experiencing atrial fibrillation after cardiac surgery; the drug class is also useful for preventing postoperative atrial fibrillation, according to new clinical practice guidelines issued by the American College of Chest Physicians.

The drugs' value stems from their antiadrenergic effect, said Peter McKeown, M.B., a member of the panel that authored the guidelines. “This counteracts the proadrenergic state patients experience after surgery, which can lead to atrial fibrillation,” he said. Bolstering the recommendation is the fact that many cardiac surgery patients are already on the drugs, which should not be discontinued before surgery.

“We should be putting them on β-blockers if they're not already on them, and keeping them on if they are,” Dr. McKeown said in an interview.

The panel, which included members of ACCP, the American College of Cardiology, the American College of Surgeons, the Society of Thoracic Surgeons, and the Society of Cardiovascular Anesthesiologists, also concluded that digoxin is contraindicated in these patients because it heightens postoperative adrenergic tone (Chest 2005;128:S1–S64).

Amiodarone was recommended for controlling rhythm in patients with postoperative AF and depressed left ventricular function, added Dr. McKeown of Duke University, Durham, N.C.

“A lot of the other drugs you hear about were not recommended because of their potential for rhythm disturbances, or because they are not suitable for patients with coronary artery disease,” he said.

The new guidelines were deemed necessary because existing guidelines don't focus on atrial fibrillation (AF) in postcardiac surgery patients, said Eric Prystowsky, M.D., a panel member and director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital, Indianapolis.

“The AF that occurs after cardiac surgery is really a unique problem that should be looked at differently than other AF issues,” he said in an interview. “It's a situation that has a temporal relationship to a very specific event, and should not be viewed as an ongoing event.”

Because of its acute nature and its common occurrence—up to 60% of cardiac surgery patients experience it—many patients leave the hospital either over- or undertreated, said Dr. Prystowsky, who also coauthored the 2001 American College of Cardiology/American Heart Association/European Society of Cardiology Guidelines for the Management of Patients With Atrial Fibrillation (J. Am. Coll. Cardiol. 2001;38:1231–66).

“If these patients fit a high-risk pattern for stroke, and many cardiac surgery patients do, then they are at a significantly increased risk if they develop AF. Many of them go home inappropriately anticoagulated. But it's not necessary for the rest of their lives. After they get back into normal rhythm, they can go back to their previous treatment regimen.”

The obsession with immediate restoration of normal heart rhythm has led to overtreatment, he added. “People are overaggressively focused on putting the rhythm back to normal acutely.”

“You don't have to give all kinds of drugs with potential toxicity. We have to remember this is an acute situation. It's perfectly acceptable to control the rate, make sure they're appropriately anticoagulated, and then let them regroup. The majority are back in normal rhythm by their 6-week checkup,” explained Dr. Prystowsky.

In constructing its recommendations, the panel conducted a comprehensive literature review that included 128 controlled trials; the evidence from each trial was graded, as were each of the subsequent recommendations.

“We looked for studies that could give answers to four goals for these patients,” Dr. McKeown said: “controlling ventricular response rate in AF, preventing thromboembolism, converting to normal sinus rhythm, and prophylaxis to prevent AF in this population.”

The panel found conflicting data on anticoagulation therapy for postoperative AF; therefore its recommendations in this area were based on expert opinion. However, the panel did recommend anticoagulation therapy in optimally selected patients with chronic AF and in those patients in whom it is likely that AF will continue.

For patients with chronic AF, the panel recommended postoperative warfarin, giving the recommendation an “A” grade, and saying the net benefit was substantial. For those with postoperative AF, the panel recommended postoperative heparin. The recommendation received a grade of “C,” with an intermediate net benefit.

The panel found no strong evidence as to duration of anticoagulation but said physicians should take into consideration the self-limiting nature of postoperative AF.

Studies comparing rates of atrial fibrillation in off-pump vs. on-pump coronary artery bypass graft procedures yielded conflicting results, the panel said. Therefore, it could not recommend off-pump procedures as a method of reducing postoperative AF.

Biatrial pacing after surgery was found to be effective in reducing the incidence of AF, and received a “B” grade, although evidence shows that the net benefit is probably small. Inconclusive evidence precluded the recommendation of isolated left or right atrial pacing.

 

 

The guidelines are meant to be just that—guidelines, Dr. McKeown said. “Evidence-based medicine gives you a rational way to treat people, but it's just one more piece of information you have to incorporate into the mix. It's still an individual choice that the physician must make based on the needs of the individual patient.”

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Gatifloxacin Is Safe and Effective for Otitis Media

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Gatifloxacin appears to be both safe and highly effective in treating acute and recurrent otitis media in children, and is not associated with either acute or long-term joint disorders, Michael Pichichero, M.D., and his colleagues reported.

In the compilation of four trials (two phase II and two phase III), they also concluded that the drug, a fluoroquinolone, was more effective in eradicating middle ear pathogens than was amoxicillin/clavulanate.

The effect of a 10-day course of gatifloxacin (10 mg/kg per day) was evaluated in 867 children aged 6 months to 7 years. The phase III trials also included 309 children who received amoxicillin/clavulanate as a comparator. All children had acute otitis media (OM), recurrent OM, or OM treatment failure (Clin. Infect. Dis. 2005;41:470–8).

In the phase II trials (414 children), the high rate of discontinuation (8%) was primarily due to vomiting because of the bitter taste of an early formulation of the drug, said Dr. Pichichero of the University of Rochester (N.Y.) and his coinvestigators. In the phase III studies, with a new formulation, the rate of discontinuation was similar in both groups (2%).

Transient arthralgia occurred in 12 (1.4%) of the 867 children. There were no abnormal imaging studies in any of the seven who were examined by an orthopedist. One child discontinued therapy due to knee swelling and abnormal gait; no joint abnormalities were seen on imaging. In the phase III studies, the rate of arthralgia was similar between the gatifloxacin and amoxicillin/clavulanate groups (1.5% and 1.3%).

One-year safety data was available for 671 gatifloxacin-treated children. There was no evidence of arthropathy in any. A 4-year-old girl treated with the study drug developed Achilles tendon pain, which resolved in 5 days with rest and ice.

Gatifloxacin was not associated with hepatotoxicity, clinically relevant hypoglycemia, phototoxicity, or central nervous system toxicity.

The cure rate of the pooled phase II studies was 81%. In the first phase III study, the cure rate of gatifloxacin was 90%, compared with 84% for amoxicillin/clavulanate. The cure rate for gatifloxacin in the second phase II study was 85%, compared with 79% for amoxicillin/clavulanate.

The study drug was especially effective in children younger than 2 years with severe acute otitis media; the cure rate was 90%, compared with 75% for the amoxicillin regimen. Gatifloxacin eradicated both Streptococcus pneumoniae and Haemophilus influenzae. It achieved highly significant clinical cure rates for pathogens that were resistant to one or two other antibiotics.

Pediatric use of gatifloxacin remains controversial, not only because of concerns about arthropathy, but because childhood resistance could impact its usefulness in adult populations, the authors noted.

However, in an accompanying editorial, Colin Marchant, M.D., said the drug deserves a chance.

Promising trial results, scheduled for discussion at a May 2004 meeting of the Food and Drug Administration's Anti-Infective Drugs Advisory Committee, were scrapped at the last minute when Bristol-Myers Squibb, the drug's manufacturer, abruptly withdrew its new drug application. The stated reason was that the drug company and the FDA could not agree on a risk-management program for the drug, said Dr. Marchant of the Boston Medical Center (Clin. Infect. Dis. 2005;41:479–80).

“The safety data on gatifloxacin use in children should be reviewed in a public forum [such as the committee],” he said. “If there are no data indicating increased risks of side effects with gatifloxacin … then recommendations for further safety studies should be put forward; and the nature and basis for a risk-management program should also be exposed to public scrutiny and discussion.”

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Gatifloxacin appears to be both safe and highly effective in treating acute and recurrent otitis media in children, and is not associated with either acute or long-term joint disorders, Michael Pichichero, M.D., and his colleagues reported.

In the compilation of four trials (two phase II and two phase III), they also concluded that the drug, a fluoroquinolone, was more effective in eradicating middle ear pathogens than was amoxicillin/clavulanate.

The effect of a 10-day course of gatifloxacin (10 mg/kg per day) was evaluated in 867 children aged 6 months to 7 years. The phase III trials also included 309 children who received amoxicillin/clavulanate as a comparator. All children had acute otitis media (OM), recurrent OM, or OM treatment failure (Clin. Infect. Dis. 2005;41:470–8).

In the phase II trials (414 children), the high rate of discontinuation (8%) was primarily due to vomiting because of the bitter taste of an early formulation of the drug, said Dr. Pichichero of the University of Rochester (N.Y.) and his coinvestigators. In the phase III studies, with a new formulation, the rate of discontinuation was similar in both groups (2%).

Transient arthralgia occurred in 12 (1.4%) of the 867 children. There were no abnormal imaging studies in any of the seven who were examined by an orthopedist. One child discontinued therapy due to knee swelling and abnormal gait; no joint abnormalities were seen on imaging. In the phase III studies, the rate of arthralgia was similar between the gatifloxacin and amoxicillin/clavulanate groups (1.5% and 1.3%).

One-year safety data was available for 671 gatifloxacin-treated children. There was no evidence of arthropathy in any. A 4-year-old girl treated with the study drug developed Achilles tendon pain, which resolved in 5 days with rest and ice.

Gatifloxacin was not associated with hepatotoxicity, clinically relevant hypoglycemia, phototoxicity, or central nervous system toxicity.

The cure rate of the pooled phase II studies was 81%. In the first phase III study, the cure rate of gatifloxacin was 90%, compared with 84% for amoxicillin/clavulanate. The cure rate for gatifloxacin in the second phase II study was 85%, compared with 79% for amoxicillin/clavulanate.

The study drug was especially effective in children younger than 2 years with severe acute otitis media; the cure rate was 90%, compared with 75% for the amoxicillin regimen. Gatifloxacin eradicated both Streptococcus pneumoniae and Haemophilus influenzae. It achieved highly significant clinical cure rates for pathogens that were resistant to one or two other antibiotics.

Pediatric use of gatifloxacin remains controversial, not only because of concerns about arthropathy, but because childhood resistance could impact its usefulness in adult populations, the authors noted.

However, in an accompanying editorial, Colin Marchant, M.D., said the drug deserves a chance.

Promising trial results, scheduled for discussion at a May 2004 meeting of the Food and Drug Administration's Anti-Infective Drugs Advisory Committee, were scrapped at the last minute when Bristol-Myers Squibb, the drug's manufacturer, abruptly withdrew its new drug application. The stated reason was that the drug company and the FDA could not agree on a risk-management program for the drug, said Dr. Marchant of the Boston Medical Center (Clin. Infect. Dis. 2005;41:479–80).

“The safety data on gatifloxacin use in children should be reviewed in a public forum [such as the committee],” he said. “If there are no data indicating increased risks of side effects with gatifloxacin … then recommendations for further safety studies should be put forward; and the nature and basis for a risk-management program should also be exposed to public scrutiny and discussion.”

Gatifloxacin appears to be both safe and highly effective in treating acute and recurrent otitis media in children, and is not associated with either acute or long-term joint disorders, Michael Pichichero, M.D., and his colleagues reported.

In the compilation of four trials (two phase II and two phase III), they also concluded that the drug, a fluoroquinolone, was more effective in eradicating middle ear pathogens than was amoxicillin/clavulanate.

The effect of a 10-day course of gatifloxacin (10 mg/kg per day) was evaluated in 867 children aged 6 months to 7 years. The phase III trials also included 309 children who received amoxicillin/clavulanate as a comparator. All children had acute otitis media (OM), recurrent OM, or OM treatment failure (Clin. Infect. Dis. 2005;41:470–8).

In the phase II trials (414 children), the high rate of discontinuation (8%) was primarily due to vomiting because of the bitter taste of an early formulation of the drug, said Dr. Pichichero of the University of Rochester (N.Y.) and his coinvestigators. In the phase III studies, with a new formulation, the rate of discontinuation was similar in both groups (2%).

Transient arthralgia occurred in 12 (1.4%) of the 867 children. There were no abnormal imaging studies in any of the seven who were examined by an orthopedist. One child discontinued therapy due to knee swelling and abnormal gait; no joint abnormalities were seen on imaging. In the phase III studies, the rate of arthralgia was similar between the gatifloxacin and amoxicillin/clavulanate groups (1.5% and 1.3%).

One-year safety data was available for 671 gatifloxacin-treated children. There was no evidence of arthropathy in any. A 4-year-old girl treated with the study drug developed Achilles tendon pain, which resolved in 5 days with rest and ice.

Gatifloxacin was not associated with hepatotoxicity, clinically relevant hypoglycemia, phototoxicity, or central nervous system toxicity.

The cure rate of the pooled phase II studies was 81%. In the first phase III study, the cure rate of gatifloxacin was 90%, compared with 84% for amoxicillin/clavulanate. The cure rate for gatifloxacin in the second phase II study was 85%, compared with 79% for amoxicillin/clavulanate.

The study drug was especially effective in children younger than 2 years with severe acute otitis media; the cure rate was 90%, compared with 75% for the amoxicillin regimen. Gatifloxacin eradicated both Streptococcus pneumoniae and Haemophilus influenzae. It achieved highly significant clinical cure rates for pathogens that were resistant to one or two other antibiotics.

Pediatric use of gatifloxacin remains controversial, not only because of concerns about arthropathy, but because childhood resistance could impact its usefulness in adult populations, the authors noted.

However, in an accompanying editorial, Colin Marchant, M.D., said the drug deserves a chance.

Promising trial results, scheduled for discussion at a May 2004 meeting of the Food and Drug Administration's Anti-Infective Drugs Advisory Committee, were scrapped at the last minute when Bristol-Myers Squibb, the drug's manufacturer, abruptly withdrew its new drug application. The stated reason was that the drug company and the FDA could not agree on a risk-management program for the drug, said Dr. Marchant of the Boston Medical Center (Clin. Infect. Dis. 2005;41:479–80).

“The safety data on gatifloxacin use in children should be reviewed in a public forum [such as the committee],” he said. “If there are no data indicating increased risks of side effects with gatifloxacin … then recommendations for further safety studies should be put forward; and the nature and basis for a risk-management program should also be exposed to public scrutiny and discussion.”

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Autonomic Neuropathy Due to Metronidazole

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SAVANNAH, GA. — Brief metronidazole treatment has been associated with a case of reversible autonomic neuropathy in a 15-year-old girl, Lisa Hobson-Webb, M.D., reported in a poster at the annual meeting of the American Association of Electrodiagnostic Medicine.

“This has never been reported in the literature,” said Dr. Hobson-Webb of Wake Forest University, Winston-Salem, N.C. “There are cases of motor or sensory neuropathies after a large dose or an extended treatment period but not any reports of autonomic involvement.”

Within 2 weeks of initiating 3-day metronidazole treatment for bacterial vaginitis, a 15-year-old girl developed such a severe, burning pain in the soles of her feet that she found relief only by keeping her feet and lower legs submerged in buckets of ice water at all times.

Nerve conduction studies showed reduced sensory nerve and compound muscle action potential.

The patient was placed on gabapentin and carbamazepine for pain control, and improved over several weeks. After 3 months, her neuropathy had clinically resolved and conduction studies showed normalization of autonomic function.

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SAVANNAH, GA. — Brief metronidazole treatment has been associated with a case of reversible autonomic neuropathy in a 15-year-old girl, Lisa Hobson-Webb, M.D., reported in a poster at the annual meeting of the American Association of Electrodiagnostic Medicine.

“This has never been reported in the literature,” said Dr. Hobson-Webb of Wake Forest University, Winston-Salem, N.C. “There are cases of motor or sensory neuropathies after a large dose or an extended treatment period but not any reports of autonomic involvement.”

Within 2 weeks of initiating 3-day metronidazole treatment for bacterial vaginitis, a 15-year-old girl developed such a severe, burning pain in the soles of her feet that she found relief only by keeping her feet and lower legs submerged in buckets of ice water at all times.

Nerve conduction studies showed reduced sensory nerve and compound muscle action potential.

The patient was placed on gabapentin and carbamazepine for pain control, and improved over several weeks. After 3 months, her neuropathy had clinically resolved and conduction studies showed normalization of autonomic function.

SAVANNAH, GA. — Brief metronidazole treatment has been associated with a case of reversible autonomic neuropathy in a 15-year-old girl, Lisa Hobson-Webb, M.D., reported in a poster at the annual meeting of the American Association of Electrodiagnostic Medicine.

“This has never been reported in the literature,” said Dr. Hobson-Webb of Wake Forest University, Winston-Salem, N.C. “There are cases of motor or sensory neuropathies after a large dose or an extended treatment period but not any reports of autonomic involvement.”

Within 2 weeks of initiating 3-day metronidazole treatment for bacterial vaginitis, a 15-year-old girl developed such a severe, burning pain in the soles of her feet that she found relief only by keeping her feet and lower legs submerged in buckets of ice water at all times.

Nerve conduction studies showed reduced sensory nerve and compound muscle action potential.

The patient was placed on gabapentin and carbamazepine for pain control, and improved over several weeks. After 3 months, her neuropathy had clinically resolved and conduction studies showed normalization of autonomic function.

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