Michele G. Sullivan

PHILADELPHIA — An “ah-ha!” moment can be the key to teen weight loss.

Adolescents who experience a “transformative event”—an experience that changes their self-concept with regard to weight or exercise—are apparently more likely to lose weight than are those who never undergo such a moment, Dr. Alexis Lieberman said at the annual meeting of the Eastern Society for Pediatric Research.

For some teens, the experience comes during a serious talk with a physician; for others, athletics is the motivating factor. But whatever the force behind the transformative event, she said, it appears to be a vital part of the weight loss experience.

Dr. Lieberman presented the results of a qualitative study of 22 teens. All of the participants were black, inner city residents with a mean age of 16 years. Additionally, all of the teens in the study had either gained or lost at least 2 kg/m

They participated in a series of structured interviews and focus group meetings, during which Dr. Lieberman and her colleagues explored important contributors to their weight change, including dietary habits, knowledge of healthy eating, finances and the impact of poverty, psychology, exercise, and home-school environment.

The group included 10 weight increasers (six males and four females) with an average body mass index (BMI) of 38 kg/m

Both of the groups had similarly poor dietary habits, she said. “Both tended to skip breakfast, eat junk food between and often instead of meals, and buy snacks at local convenience stores and fast food restaurants. Nobody ate very well.”

Interestingly, Dr. Lieberman said, the teens did have a good basic knowledge of what constitutes a healthy diet, and they could accurately describe a balanced meal.

Poverty did not play as large a role as the researchers anticipated. While a lack of money did increase a teen's tendency to buy cheap, low-quality foods, it also forced many into the subsidized food programs at their schools.

“Not having money meant they couldn't buy french fries in the cafeteria, and instead had to go to the free lunch line, where the food was supposedly healthier,” said Dr. Lieberman, a pediatrician at Albert Einstein Medical Center, Philadelphia.

Several important thematic differences emerged between the groups, including the transformative experience, family support, and exercise.

A transformative experience occurred in six of the weight decreasers and only two of the weight increasers.

For several of the decreasers, the moment was a meeting with a physician, especially being told they were at risk of developing diabetes. Some related that prognosis to the same illness in a relative, and made a decision to change their own future.

For others, Dr. Lieberman said, the moment had to do with athletics. One teen was recruited from his recreation center basketball team to a traveling city team, and had to lose weight to stay on the team. Another girl joined the track team. Her coach advised her to improve her eating habits and lose weight because she had the potential to be a fast runner.

“These moments were related to an increase in self-esteem,” Dr. Lieberman said.

One decreaser was sentenced to boot camp for stealing cars. The rigorously active schedule and opportunity for self-evaluation were his triggers for weight loss.

“Three years later, he has maintained the loss and continues to lift weights,” she added.

A violent experience changed the life of the final weight decreaser. He was almost “jumped,” Dr. Lieberman said. His grandfather then signed him up for a martial arts program at the local gym.

“A supportive family member helped make this a transformative moment, instead of a damaging one,” she said.

Transformative experiences also occurred in two teens who gained weight. One said his religious conversion allowed him to accept himself “as a big person.” Another teen learned she was a prediabetic, but wasn't able to make the changes necessary to lose weight.

Exercise was another big difference between the groups, Dr. Lieberman said. Eight of the decreasers consistently engaged in intense physical activity (at least 2 hours each day of team sports or weight lifting), compared with only one of the increasers. “The one increaser who exercised was on a dance team that served doughnuts after practice.”

The final difference between the groups was family influence. The decreasing group reported that family members tried to positively influence their diet, and encouraged their weight loss.

The teens who increased their weight, however, reported that they received support to accept their weight, with their family using euphemisms (“You're thick, not fat”) and telling them they “looked fine just as they were.”

“Parents do find the term 'overweight' or 'fat' offensive,” Dr. Lieberman said. “They prefer terms like 'gaining weight too quickly' or 'big for his age.'”

Family members who encouraged weight loss and healthy diet played a crucial role in teens' weight loss. DR. LIEBERMAN

PHILADELPHIA — An “ah-ha!” moment can be the key to teen weight loss.

Adolescents who experience a “transformative event”—an experience that changes their self-concept with regard to weight or exercise—are apparently more likely to lose weight than are those who never undergo such a moment, Dr. Alexis Lieberman said at the annual meeting of the Eastern Society for Pediatric Research.

For some teens, the experience comes during a serious talk with a physician; for others, athletics is the motivating factor. But whatever the force behind the transformative event, she said, it appears to be a vital part of the weight loss experience.

Dr. Lieberman presented the results of a qualitative study of 22 teens. All of the participants were black, inner city residents with a mean age of 16 years. Additionally, all of the teens in the study had either gained or lost at least 2 kg/m

They participated in a series of structured interviews and focus group meetings, during which Dr. Lieberman and her colleagues explored important contributors to their weight change, including dietary habits, knowledge of healthy eating, finances and the impact of poverty, psychology, exercise, and home-school environment.

The group included 10 weight increasers (six males and four females) with an average body mass index (BMI) of 38 kg/m

Both of the groups had similarly poor dietary habits, she said. “Both tended to skip breakfast, eat junk food between and often instead of meals, and buy snacks at local convenience stores and fast food restaurants. Nobody ate very well.”

Interestingly, Dr. Lieberman said, the teens did have a good basic knowledge of what constitutes a healthy diet, and they could accurately describe a balanced meal.

Poverty did not play as large a role as the researchers anticipated. While a lack of money did increase a teen's tendency to buy cheap, low-quality foods, it also forced many into the subsidized food programs at their schools.

“Not having money meant they couldn't buy french fries in the cafeteria, and instead had to go to the free lunch line, where the food was supposedly healthier,” said Dr. Lieberman, a pediatrician at Albert Einstein Medical Center, Philadelphia.

Several important thematic differences emerged between the groups, including the transformative experience, family support, and exercise.

A transformative experience occurred in six of the weight decreasers and only two of the weight increasers.

For several of the decreasers, the moment was a meeting with a physician, especially being told they were at risk of developing diabetes. Some related that prognosis to the same illness in a relative, and made a decision to change their own future.

For others, Dr. Lieberman said, the moment had to do with athletics. One teen was recruited from his recreation center basketball team to a traveling city team, and had to lose weight to stay on the team. Another girl joined the track team. Her coach advised her to improve her eating habits and lose weight because she had the potential to be a fast runner.

“These moments were related to an increase in self-esteem,” Dr. Lieberman said.

One decreaser was sentenced to boot camp for stealing cars. The rigorously active schedule and opportunity for self-evaluation were his triggers for weight loss.

“Three years later, he has maintained the loss and continues to lift weights,” she added.

A violent experience changed the life of the final weight decreaser. He was almost “jumped,” Dr. Lieberman said. His grandfather then signed him up for a martial arts program at the local gym.

“A supportive family member helped make this a transformative moment, instead of a damaging one,” she said.

Transformative experiences also occurred in two teens who gained weight. One said his religious conversion allowed him to accept himself “as a big person.” Another teen learned she was a prediabetic, but wasn't able to make the changes necessary to lose weight.

Exercise was another big difference between the groups, Dr. Lieberman said. Eight of the decreasers consistently engaged in intense physical activity (at least 2 hours each day of team sports or weight lifting), compared with only one of the increasers. “The one increaser who exercised was on a dance team that served doughnuts after practice.”

The final difference between the groups was family influence. The decreasing group reported that family members tried to positively influence their diet, and encouraged their weight loss.

The teens who increased their weight, however, reported that they received support to accept their weight, with their family using euphemisms (“You're thick, not fat”) and telling them they “looked fine just as they were.”

“Parents do find the term 'overweight' or 'fat' offensive,” Dr. Lieberman said. “They prefer terms like 'gaining weight too quickly' or 'big for his age.'”

Family members who encouraged weight loss and healthy diet played a crucial role in teens' weight loss. DR. LIEBERMAN

PHILADELPHIA — An “ah-ha!” moment can be the key to teen weight loss.

Adolescents who experience a “transformative event”—an experience that changes their self-concept with regard to weight or exercise—are apparently more likely to lose weight than are those who never undergo such a moment, Dr. Alexis Lieberman said at the annual meeting of the Eastern Society for Pediatric Research.

For some teens, the experience comes during a serious talk with a physician; for others, athletics is the motivating factor. But whatever the force behind the transformative event, she said, it appears to be a vital part of the weight loss experience.

Dr. Lieberman presented the results of a qualitative study of 22 teens. All of the participants were black, inner city residents with a mean age of 16 years. Additionally, all of the teens in the study had either gained or lost at least 2 kg/m

They participated in a series of structured interviews and focus group meetings, during which Dr. Lieberman and her colleagues explored important contributors to their weight change, including dietary habits, knowledge of healthy eating, finances and the impact of poverty, psychology, exercise, and home-school environment.

The group included 10 weight increasers (six males and four females) with an average body mass index (BMI) of 38 kg/m

Both of the groups had similarly poor dietary habits, she said. “Both tended to skip breakfast, eat junk food between and often instead of meals, and buy snacks at local convenience stores and fast food restaurants. Nobody ate very well.”

Interestingly, Dr. Lieberman said, the teens did have a good basic knowledge of what constitutes a healthy diet, and they could accurately describe a balanced meal.

Poverty did not play as large a role as the researchers anticipated. While a lack of money did increase a teen's tendency to buy cheap, low-quality foods, it also forced many into the subsidized food programs at their schools.

“Not having money meant they couldn't buy french fries in the cafeteria, and instead had to go to the free lunch line, where the food was supposedly healthier,” said Dr. Lieberman, a pediatrician at Albert Einstein Medical Center, Philadelphia.

Several important thematic differences emerged between the groups, including the transformative experience, family support, and exercise.

A transformative experience occurred in six of the weight decreasers and only two of the weight increasers.

For several of the decreasers, the moment was a meeting with a physician, especially being told they were at risk of developing diabetes. Some related that prognosis to the same illness in a relative, and made a decision to change their own future.

For others, Dr. Lieberman said, the moment had to do with athletics. One teen was recruited from his recreation center basketball team to a traveling city team, and had to lose weight to stay on the team. Another girl joined the track team. Her coach advised her to improve her eating habits and lose weight because she had the potential to be a fast runner.

“These moments were related to an increase in self-esteem,” Dr. Lieberman said.

One decreaser was sentenced to boot camp for stealing cars. The rigorously active schedule and opportunity for self-evaluation were his triggers for weight loss.

“Three years later, he has maintained the loss and continues to lift weights,” she added.

A violent experience changed the life of the final weight decreaser. He was almost “jumped,” Dr. Lieberman said. His grandfather then signed him up for a martial arts program at the local gym.

“A supportive family member helped make this a transformative moment, instead of a damaging one,” she said.

Transformative experiences also occurred in two teens who gained weight. One said his religious conversion allowed him to accept himself “as a big person.” Another teen learned she was a prediabetic, but wasn't able to make the changes necessary to lose weight.

Exercise was another big difference between the groups, Dr. Lieberman said. Eight of the decreasers consistently engaged in intense physical activity (at least 2 hours each day of team sports or weight lifting), compared with only one of the increasers. “The one increaser who exercised was on a dance team that served doughnuts after practice.”

The final difference between the groups was family influence. The decreasing group reported that family members tried to positively influence their diet, and encouraged their weight loss.

The teens who increased their weight, however, reported that they received support to accept their weight, with their family using euphemisms (“You're thick, not fat”) and telling them they “looked fine just as they were.”

“Parents do find the term 'overweight' or 'fat' offensive,” Dr. Lieberman said. “They prefer terms like 'gaining weight too quickly' or 'big for his age.'”

Family members who encouraged weight loss and healthy diet played a crucial role in teens' weight loss. DR. LIEBERMAN

The benefits of hormone therapy outweigh its risks in healthy perimenopausal and early-postmenopausal women with menopause-related symptoms and a low baseline risk of stroke, according to the revised position statement released by the North American Menopause Society.

However, the paper cautioned, that HT should not be prescribed for the prevention of any disease, with the exception of postmenopausal osteoporosis.

HT can be prescribed for the prevention of postmenopausal osteoporosis in women who require drug therapy to maintain bone. “There is strong evidence of the efficacy of [HT] in reducing the risk of postmenopausal osteoporotic bone fracture,” the statement read.

For women at risk of a fracture during the next 5–10 years, HT can be an option—but only after a careful risk/benefit analysis.

The statement is based on an expert panel's review of HT studies published subsequent to the group's 2004 position paper, said Dr. Wulf Utian, executive director of the North American Menopause Society (NAMS) in Cleveland. “In this day and age, the life span of any position statement is a maximum of 2 or 3 years,” Dr. Utian said in an interview. “In the face of so much new information, we felt an update was due.”

The clinical impacts of HT's short- and long-term effects are becoming clearer, especially as additional subanalyses of the Women's Health Initiative (WHI) and the Heart and Estrogen/Progestin Replacement Study (HERS) begin to emerge, he said.

Results of these and other studies enabled more expert consensus in the new paper than was previously possible—most significantly, Dr. Utian said, in the area of cardiovascular disease risk.

“We have modified our stance on level of risk from 2004,” he explained.

“Apart from the increased risk of stroke in the older woman [taking HT], the absolute risk of stroke and heart attack is rare, and we agreed that any evidence of an increase in heart attack in the perimenopausal woman was poor. We have concluded that for the symptomatic woman without a contraindication, the benefits of HT outweigh the risks, and that these women have less cause to fear than the popular perception,” said Dr. Utian.

Two well-publicized, large studies have precipitated much of the current confusion over the safety of HT, appropriate treatment populations, and timing of therapy, the statement said. “The results of WHI and HERS should not be extrapolated to symptomatic postmenopausal women younger than 50 years of age, who initiate HT at that time, as these women were not studied in those trials.”

“We state very clearly there is no cookbook recipe. Each woman has her own potential indications and risk factors, and only a comprehensive evaluation and discussion is going to decide what is most appropriate for that individual,” Dr. Utian stressed.

The NAMS statement is available at www.menopause.org/aboutmeno/consensus.htm

'There is no cookbook recipe. Each woman has her own potential indications and risk factors.' DR. UTIAN

The benefits of hormone therapy outweigh its risks in healthy perimenopausal and early-postmenopausal women with menopause-related symptoms and a low baseline risk of stroke, according to the revised position statement released by the North American Menopause Society.

However, the paper cautioned, that HT should not be prescribed for the prevention of any disease, with the exception of postmenopausal osteoporosis.

HT can be prescribed for the prevention of postmenopausal osteoporosis in women who require drug therapy to maintain bone. “There is strong evidence of the efficacy of [HT] in reducing the risk of postmenopausal osteoporotic bone fracture,” the statement read.

For women at risk of a fracture during the next 5–10 years, HT can be an option—but only after a careful risk/benefit analysis.

The statement is based on an expert panel's review of HT studies published subsequent to the group's 2004 position paper, said Dr. Wulf Utian, executive director of the North American Menopause Society (NAMS) in Cleveland. “In this day and age, the life span of any position statement is a maximum of 2 or 3 years,” Dr. Utian said in an interview. “In the face of so much new information, we felt an update was due.”

The clinical impacts of HT's short- and long-term effects are becoming clearer, especially as additional subanalyses of the Women's Health Initiative (WHI) and the Heart and Estrogen/Progestin Replacement Study (HERS) begin to emerge, he said.

Results of these and other studies enabled more expert consensus in the new paper than was previously possible—most significantly, Dr. Utian said, in the area of cardiovascular disease risk.

“We have modified our stance on level of risk from 2004,” he explained.

“Apart from the increased risk of stroke in the older woman [taking HT], the absolute risk of stroke and heart attack is rare, and we agreed that any evidence of an increase in heart attack in the perimenopausal woman was poor. We have concluded that for the symptomatic woman without a contraindication, the benefits of HT outweigh the risks, and that these women have less cause to fear than the popular perception,” said Dr. Utian.

Two well-publicized, large studies have precipitated much of the current confusion over the safety of HT, appropriate treatment populations, and timing of therapy, the statement said. “The results of WHI and HERS should not be extrapolated to symptomatic postmenopausal women younger than 50 years of age, who initiate HT at that time, as these women were not studied in those trials.”

“We state very clearly there is no cookbook recipe. Each woman has her own potential indications and risk factors, and only a comprehensive evaluation and discussion is going to decide what is most appropriate for that individual,” Dr. Utian stressed.

The NAMS statement is available at www.menopause.org/aboutmeno/consensus.htm

'There is no cookbook recipe. Each woman has her own potential indications and risk factors.' DR. UTIAN

The benefits of hormone therapy outweigh its risks in healthy perimenopausal and early-postmenopausal women with menopause-related symptoms and a low baseline risk of stroke, according to the revised position statement released by the North American Menopause Society.

However, the paper cautioned, that HT should not be prescribed for the prevention of any disease, with the exception of postmenopausal osteoporosis.

HT can be prescribed for the prevention of postmenopausal osteoporosis in women who require drug therapy to maintain bone. “There is strong evidence of the efficacy of [HT] in reducing the risk of postmenopausal osteoporotic bone fracture,” the statement read.

For women at risk of a fracture during the next 5–10 years, HT can be an option—but only after a careful risk/benefit analysis.

The statement is based on an expert panel's review of HT studies published subsequent to the group's 2004 position paper, said Dr. Wulf Utian, executive director of the North American Menopause Society (NAMS) in Cleveland. “In this day and age, the life span of any position statement is a maximum of 2 or 3 years,” Dr. Utian said in an interview. “In the face of so much new information, we felt an update was due.”

The clinical impacts of HT's short- and long-term effects are becoming clearer, especially as additional subanalyses of the Women's Health Initiative (WHI) and the Heart and Estrogen/Progestin Replacement Study (HERS) begin to emerge, he said.

Results of these and other studies enabled more expert consensus in the new paper than was previously possible—most significantly, Dr. Utian said, in the area of cardiovascular disease risk.

“We have modified our stance on level of risk from 2004,” he explained.

“Apart from the increased risk of stroke in the older woman [taking HT], the absolute risk of stroke and heart attack is rare, and we agreed that any evidence of an increase in heart attack in the perimenopausal woman was poor. We have concluded that for the symptomatic woman without a contraindication, the benefits of HT outweigh the risks, and that these women have less cause to fear than the popular perception,” said Dr. Utian.

Two well-publicized, large studies have precipitated much of the current confusion over the safety of HT, appropriate treatment populations, and timing of therapy, the statement said. “The results of WHI and HERS should not be extrapolated to symptomatic postmenopausal women younger than 50 years of age, who initiate HT at that time, as these women were not studied in those trials.”

“We state very clearly there is no cookbook recipe. Each woman has her own potential indications and risk factors, and only a comprehensive evaluation and discussion is going to decide what is most appropriate for that individual,” Dr. Utian stressed.

The NAMS statement is available at www.menopause.org/aboutmeno/consensus.htm

'There is no cookbook recipe. Each woman has her own potential indications and risk factors.' DR. UTIAN

Women considering the risks and benefits of hormone therapy should be informed of the link between hormones and a decreased risk of diabetes, especially if they are at risk for the disorder, according to Dr. Wulf Utian, executive director of the North American Menopause Society in Cleveland.

“While hormone therapy [HT] is not indicated for the prevention of diabetes, women with diabetes risk factors who are considering it for a valid indication should understand the evidence in this area,” Dr. Utian said in an interview. NAMs' newly revised position statement on HT is the group's first to review this evidence.

The paper reviewed three studies on the subject, granting Class I status to the evidence presented in each one: two subanalyses of the Women's Health Initiative (WHI) and one subanalysis of the Heart and Estrogen/Progestin Replacement Study (HERS).

The first of the WHI studies, published in 2004, examined the effect of HT on diabetes development in the 16,600 women included in the estrogen/progestin arm (Diabetologia 2004;47:1175–87). After 5 years of follow-up, women in the active group were 21% less likely to develop diabetes than those in the placebo group (277 cases vs. 324 cases).

The numbers achieved greater significance when the analysis was restricted to the small subgroup of women who remained compliant with therapy throughout the follow-up period. In this group, the decreased risk was 33%. The difference seemed to be driven by steady improvements in fasting glucose and insulin resistance in the active group, the authors wrote. The risk ratios remained unchanged after adjusting for body mass index (BMI) and waist circumference.

Insulin resistance and glucose level were also the driving forces behind the smaller risk reductions seen among women in WHI's estrogen-only arm (Diabetologia 2006;49:459–68). This study included 9,712 women. At year 6, women in the active group were 12% less likely to have developed diabetes than those in the placebo group (a rate of 8.3% vs. a rate of 9.3%). This difference was not significant in the overall group, but became highly so in the smaller group of women who were compliant with therapy through the study's end. These women were 27% less likely to develop diabetes than the placebo group.

Again, adjusting for BMI and waist circumference did not account for the difference, the authors said. Instead, the risk reduction seemed to be related to improvements in fasting glucose and insulin resistance. These were significant within the first year of therapy and then waned in the overall group, but remained significant in the compliant group.

The final study, a subanalysis of the HERS data, confirmed HT's beneficial effect on diabetes development in women with preexisting coronary heart disease. The subanalysis followed 2,029 patients who did not have diabetes at baseline (Ann. Intern. Med. 2003;138:1–9).

At 4 years' follow-up, the incidence of diabetes in the active group was 6.2%, compared with 9.5% in the placebo group—a significant risk reduction of 35%. The risk differential was related to significantly higher fasting glucose levels in the placebo group; these levels remained stable in the active group. There was no association of decreased diabetes with the active group's modest decreases in BMI or waist circumference.

More research is necessary to further define HT's impact on diabetes, Dr. Utian said.

Women considering the risks and benefits of hormone therapy should be informed of the link between hormones and a decreased risk of diabetes, especially if they are at risk for the disorder, according to Dr. Wulf Utian, executive director of the North American Menopause Society in Cleveland.

“While hormone therapy [HT] is not indicated for the prevention of diabetes, women with diabetes risk factors who are considering it for a valid indication should understand the evidence in this area,” Dr. Utian said in an interview. NAMs' newly revised position statement on HT is the group's first to review this evidence.

The paper reviewed three studies on the subject, granting Class I status to the evidence presented in each one: two subanalyses of the Women's Health Initiative (WHI) and one subanalysis of the Heart and Estrogen/Progestin Replacement Study (HERS).

The first of the WHI studies, published in 2004, examined the effect of HT on diabetes development in the 16,600 women included in the estrogen/progestin arm (Diabetologia 2004;47:1175–87). After 5 years of follow-up, women in the active group were 21% less likely to develop diabetes than those in the placebo group (277 cases vs. 324 cases).

The numbers achieved greater significance when the analysis was restricted to the small subgroup of women who remained compliant with therapy throughout the follow-up period. In this group, the decreased risk was 33%. The difference seemed to be driven by steady improvements in fasting glucose and insulin resistance in the active group, the authors wrote. The risk ratios remained unchanged after adjusting for body mass index (BMI) and waist circumference.

Insulin resistance and glucose level were also the driving forces behind the smaller risk reductions seen among women in WHI's estrogen-only arm (Diabetologia 2006;49:459–68). This study included 9,712 women. At year 6, women in the active group were 12% less likely to have developed diabetes than those in the placebo group (a rate of 8.3% vs. a rate of 9.3%). This difference was not significant in the overall group, but became highly so in the smaller group of women who were compliant with therapy through the study's end. These women were 27% less likely to develop diabetes than the placebo group.

Again, adjusting for BMI and waist circumference did not account for the difference, the authors said. Instead, the risk reduction seemed to be related to improvements in fasting glucose and insulin resistance. These were significant within the first year of therapy and then waned in the overall group, but remained significant in the compliant group.

The final study, a subanalysis of the HERS data, confirmed HT's beneficial effect on diabetes development in women with preexisting coronary heart disease. The subanalysis followed 2,029 patients who did not have diabetes at baseline (Ann. Intern. Med. 2003;138:1–9).

At 4 years' follow-up, the incidence of diabetes in the active group was 6.2%, compared with 9.5% in the placebo group—a significant risk reduction of 35%. The risk differential was related to significantly higher fasting glucose levels in the placebo group; these levels remained stable in the active group. There was no association of decreased diabetes with the active group's modest decreases in BMI or waist circumference.

More research is necessary to further define HT's impact on diabetes, Dr. Utian said.

Women considering the risks and benefits of hormone therapy should be informed of the link between hormones and a decreased risk of diabetes, especially if they are at risk for the disorder, according to Dr. Wulf Utian, executive director of the North American Menopause Society in Cleveland.

“While hormone therapy [HT] is not indicated for the prevention of diabetes, women with diabetes risk factors who are considering it for a valid indication should understand the evidence in this area,” Dr. Utian said in an interview. NAMs' newly revised position statement on HT is the group's first to review this evidence.

The paper reviewed three studies on the subject, granting Class I status to the evidence presented in each one: two subanalyses of the Women's Health Initiative (WHI) and one subanalysis of the Heart and Estrogen/Progestin Replacement Study (HERS).

The first of the WHI studies, published in 2004, examined the effect of HT on diabetes development in the 16,600 women included in the estrogen/progestin arm (Diabetologia 2004;47:1175–87). After 5 years of follow-up, women in the active group were 21% less likely to develop diabetes than those in the placebo group (277 cases vs. 324 cases).

The numbers achieved greater significance when the analysis was restricted to the small subgroup of women who remained compliant with therapy throughout the follow-up period. In this group, the decreased risk was 33%. The difference seemed to be driven by steady improvements in fasting glucose and insulin resistance in the active group, the authors wrote. The risk ratios remained unchanged after adjusting for body mass index (BMI) and waist circumference.

Insulin resistance and glucose level were also the driving forces behind the smaller risk reductions seen among women in WHI's estrogen-only arm (Diabetologia 2006;49:459–68). This study included 9,712 women. At year 6, women in the active group were 12% less likely to have developed diabetes than those in the placebo group (a rate of 8.3% vs. a rate of 9.3%). This difference was not significant in the overall group, but became highly so in the smaller group of women who were compliant with therapy through the study's end. These women were 27% less likely to develop diabetes than the placebo group.

Again, adjusting for BMI and waist circumference did not account for the difference, the authors said. Instead, the risk reduction seemed to be related to improvements in fasting glucose and insulin resistance. These were significant within the first year of therapy and then waned in the overall group, but remained significant in the compliant group.

The final study, a subanalysis of the HERS data, confirmed HT's beneficial effect on diabetes development in women with preexisting coronary heart disease. The subanalysis followed 2,029 patients who did not have diabetes at baseline (Ann. Intern. Med. 2003;138:1–9).

At 4 years' follow-up, the incidence of diabetes in the active group was 6.2%, compared with 9.5% in the placebo group—a significant risk reduction of 35%. The risk differential was related to significantly higher fasting glucose levels in the placebo group; these levels remained stable in the active group. There was no association of decreased diabetes with the active group's modest decreases in BMI or waist circumference.

More research is necessary to further define HT's impact on diabetes, Dr. Utian said.

PHILADELPHIA — A single split unit of infected blood was the source of Babesia microti infections in four very-low-birth-weight babies in Rhode Island, Dr. Kari Simonsen reported at the annual meeting of the Eastern Society for Pediatric Research.

The first case was seen in an acutely ill 35-day-old infant born at 25 weeks' gestation. The other three cases were identified after a search for other recipients of the suspect blood. None of these infants was seriously ill. Unlike the index case, who had a parasitemia level of 17%, the other three infants had low levels of parasitemia, said Dr. Simonsen, a pediatric infectious disease fellow at Brown University, Providence, R.I.

B. microti is an erythrocytic parasite similar to Plasmodium—the cause of malaria. The parasite is transmitted via tick bite to a human. It is endemic in the Northeast and upper Midwest of the United States, where up to 10% of the population is infected, Dr. Simonsen said.

Blood banks do not routinely screen for the parasite in donations, despite the prevalence of infections in some regions. “Up to 1.4% of blood donated in hyperendemic regions is seropositive and up to 53% [of the seropositive blood] is positive by [polymerase chain reaction],” she said.

The index infant weighed 760 g at birth, and on day 2 received a transfusion for anemia. On day 35, the infant developed worsening apnea, respiratory distress requiring reintubation, fever, edema, hepatosplenomegaly, hemolytic anemic, and thrombocytopenia.

The initial workup, which was unrevealing, included blood, urine, and cerebrospinal fluid cultures, and viral studies. The patient was managed with ampicillin, gentamicin, and amphotericin B.

When the infant was 50 days old, a blood smear was done; a laboratory technician noted the typical intraerythrocytic “Maltese cross” formation of the Babesia parasite, with 17% of the red blood cells parasitized. “The infant immediately received a double-volume exchange transfusion, and clindamycin and quinine were started,” Dr. Simonsen said.

By treatment day 6, the infant still had a parasitemia of about 6%. Another double volume exchange transfusion was performed; azithromycin and atovaquone were added to the existing medical therapy. By day 9, the parasitemia had decreased to 0.09%, and quinine was discontinued. A week later, the infant's blood smear was negative, but parasitemia increased to 0.03% on day 20. “This patient experienced a long period of low, but not absent, parasitemia,” Dr. Simonsen said. Medical therapy was continued until two consecutive negative smears were obtained (days 24 and 27). On day 28, antibiotics were discontinued.

A blood bank investigation identified three additional infants who had received transfusions from the same unit of blood, all of whom were asymptomatic or mildly symptomatic. Case 2 had only a single organism on blood smear, and was managed with clindamycin and quinine. The smear was negative after just 1 day of treatment. Case 3 had a parasitemia of 0.9%, received clindamycin and quinine, and had a negative smear after 14 days. The final case had a parasitemia of 1.5%, and also was negative after 14 days of clindamycin and quinine.

Epidemiologists could find no reason for the large load in the index case, Dr. Simonsen said. “That infant did not receive a larger share of the blood than our other cases.”

Dr. Peter J. Krause, director of the division of infectious diseases in the department of pediatrics at the University of Connecticut, Farmington, commented on the identification of infants with suspected babesiosis.

“It's probably not worth a routine smear, but if you have a neonate who has been transfused and is not doing well, with increasing liver enzymes or splenomegaly, it might be something to order.” The incubation period in transfusion-related cases is typically 6–9 weeks, he said at the meeting.

Up to 1.4% of blood donated in hyperendemic regions (such as the Northeast U.S.)is seropositive. DR. SIMONSEN

PHILADELPHIA — A single split unit of infected blood was the source of Babesia microti infections in four very-low-birth-weight babies in Rhode Island, Dr. Kari Simonsen reported at the annual meeting of the Eastern Society for Pediatric Research.

The first case was seen in an acutely ill 35-day-old infant born at 25 weeks' gestation. The other three cases were identified after a search for other recipients of the suspect blood. None of these infants was seriously ill. Unlike the index case, who had a parasitemia level of 17%, the other three infants had low levels of parasitemia, said Dr. Simonsen, a pediatric infectious disease fellow at Brown University, Providence, R.I.

B. microti is an erythrocytic parasite similar to Plasmodium—the cause of malaria. The parasite is transmitted via tick bite to a human. It is endemic in the Northeast and upper Midwest of the United States, where up to 10% of the population is infected, Dr. Simonsen said.

Blood banks do not routinely screen for the parasite in donations, despite the prevalence of infections in some regions. “Up to 1.4% of blood donated in hyperendemic regions is seropositive and up to 53% [of the seropositive blood] is positive by [polymerase chain reaction],” she said.

The index infant weighed 760 g at birth, and on day 2 received a transfusion for anemia. On day 35, the infant developed worsening apnea, respiratory distress requiring reintubation, fever, edema, hepatosplenomegaly, hemolytic anemic, and thrombocytopenia.

The initial workup, which was unrevealing, included blood, urine, and cerebrospinal fluid cultures, and viral studies. The patient was managed with ampicillin, gentamicin, and amphotericin B.

When the infant was 50 days old, a blood smear was done; a laboratory technician noted the typical intraerythrocytic “Maltese cross” formation of the Babesia parasite, with 17% of the red blood cells parasitized. “The infant immediately received a double-volume exchange transfusion, and clindamycin and quinine were started,” Dr. Simonsen said.

By treatment day 6, the infant still had a parasitemia of about 6%. Another double volume exchange transfusion was performed; azithromycin and atovaquone were added to the existing medical therapy. By day 9, the parasitemia had decreased to 0.09%, and quinine was discontinued. A week later, the infant's blood smear was negative, but parasitemia increased to 0.03% on day 20. “This patient experienced a long period of low, but not absent, parasitemia,” Dr. Simonsen said. Medical therapy was continued until two consecutive negative smears were obtained (days 24 and 27). On day 28, antibiotics were discontinued.

A blood bank investigation identified three additional infants who had received transfusions from the same unit of blood, all of whom were asymptomatic or mildly symptomatic. Case 2 had only a single organism on blood smear, and was managed with clindamycin and quinine. The smear was negative after just 1 day of treatment. Case 3 had a parasitemia of 0.9%, received clindamycin and quinine, and had a negative smear after 14 days. The final case had a parasitemia of 1.5%, and also was negative after 14 days of clindamycin and quinine.

Epidemiologists could find no reason for the large load in the index case, Dr. Simonsen said. “That infant did not receive a larger share of the blood than our other cases.”

Dr. Peter J. Krause, director of the division of infectious diseases in the department of pediatrics at the University of Connecticut, Farmington, commented on the identification of infants with suspected babesiosis.

“It's probably not worth a routine smear, but if you have a neonate who has been transfused and is not doing well, with increasing liver enzymes or splenomegaly, it might be something to order.” The incubation period in transfusion-related cases is typically 6–9 weeks, he said at the meeting.

Up to 1.4% of blood donated in hyperendemic regions (such as the Northeast U.S.)is seropositive. DR. SIMONSEN

PHILADELPHIA — A single split unit of infected blood was the source of Babesia microti infections in four very-low-birth-weight babies in Rhode Island, Dr. Kari Simonsen reported at the annual meeting of the Eastern Society for Pediatric Research.

The first case was seen in an acutely ill 35-day-old infant born at 25 weeks' gestation. The other three cases were identified after a search for other recipients of the suspect blood. None of these infants was seriously ill. Unlike the index case, who had a parasitemia level of 17%, the other three infants had low levels of parasitemia, said Dr. Simonsen, a pediatric infectious disease fellow at Brown University, Providence, R.I.

B. microti is an erythrocytic parasite similar to Plasmodium—the cause of malaria. The parasite is transmitted via tick bite to a human. It is endemic in the Northeast and upper Midwest of the United States, where up to 10% of the population is infected, Dr. Simonsen said.

Blood banks do not routinely screen for the parasite in donations, despite the prevalence of infections in some regions. “Up to 1.4% of blood donated in hyperendemic regions is seropositive and up to 53% [of the seropositive blood] is positive by [polymerase chain reaction],” she said.

The index infant weighed 760 g at birth, and on day 2 received a transfusion for anemia. On day 35, the infant developed worsening apnea, respiratory distress requiring reintubation, fever, edema, hepatosplenomegaly, hemolytic anemic, and thrombocytopenia.

The initial workup, which was unrevealing, included blood, urine, and cerebrospinal fluid cultures, and viral studies. The patient was managed with ampicillin, gentamicin, and amphotericin B.

When the infant was 50 days old, a blood smear was done; a laboratory technician noted the typical intraerythrocytic “Maltese cross” formation of the Babesia parasite, with 17% of the red blood cells parasitized. “The infant immediately received a double-volume exchange transfusion, and clindamycin and quinine were started,” Dr. Simonsen said.

By treatment day 6, the infant still had a parasitemia of about 6%. Another double volume exchange transfusion was performed; azithromycin and atovaquone were added to the existing medical therapy. By day 9, the parasitemia had decreased to 0.09%, and quinine was discontinued. A week later, the infant's blood smear was negative, but parasitemia increased to 0.03% on day 20. “This patient experienced a long period of low, but not absent, parasitemia,” Dr. Simonsen said. Medical therapy was continued until two consecutive negative smears were obtained (days 24 and 27). On day 28, antibiotics were discontinued.

A blood bank investigation identified three additional infants who had received transfusions from the same unit of blood, all of whom were asymptomatic or mildly symptomatic. Case 2 had only a single organism on blood smear, and was managed with clindamycin and quinine. The smear was negative after just 1 day of treatment. Case 3 had a parasitemia of 0.9%, received clindamycin and quinine, and had a negative smear after 14 days. The final case had a parasitemia of 1.5%, and also was negative after 14 days of clindamycin and quinine.

Epidemiologists could find no reason for the large load in the index case, Dr. Simonsen said. “That infant did not receive a larger share of the blood than our other cases.”

Dr. Peter J. Krause, director of the division of infectious diseases in the department of pediatrics at the University of Connecticut, Farmington, commented on the identification of infants with suspected babesiosis.

“It's probably not worth a routine smear, but if you have a neonate who has been transfused and is not doing well, with increasing liver enzymes or splenomegaly, it might be something to order.” The incubation period in transfusion-related cases is typically 6–9 weeks, he said at the meeting.

Up to 1.4% of blood donated in hyperendemic regions (such as the Northeast U.S.)is seropositive. DR. SIMONSEN

PHILADELPHIA — Infants who receive prophylactic palivizumab at home are more likely to get all their doses on time than are those who receive the injections at their pediatrician's office, Dr. Caroline O. Chua reported at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Chua of the Maria Fareri Children's Hospital, Valhalla, N.Y., did a prospective review that included 1,362 infants eligible for respiratory syncytial virus (RSV) prophylaxis during the 2005–2006 RSV season.

Upon discharge from the neonatal intensive care unit, 744 of the infants were scheduled to receive their monthly injections in their pediatricians' offices. The remaining 618 were scheduled to receive the injections at home through the services of a home health care agency.

All of the infants received their first dose of the drug within 24–48 hours of discharge.

But infants scheduled for at-home therapy received significantly more of their scheduled doses on time (95% compliance rate) than did the in-office group (91% compliance rate).

Total hospitalizations, including those secondary to RSV infection, were significantly higher among the in-office group than the in-home group (16 vs. 2). Hospitalizations caused by RSV infections only also were higher in the in-office group, but the difference was not statistically significant (5 vs. 1).

Although the in-office compliance rate leaves something to be desired, it does show a significant improvement from the rate observed in a similar study performed in the same community during the 2001–2002 RSV season, Dr. Chua said.

That study followed 1,446 infants, 969 of whom received their monthly injections at home. The compliance rate was significantly higher than that observed among the 477 who received their injections in the office setting (98% vs. 89%) (Ped. Infect. Dis. 2004;23:318–22).

“We speculate that the increased compliance in offices could be a reflection of better education on the part of pediatricians or media exposure that reached parents,” she said.

The half-life of palivizumab is only 20 days, Dr. Chua noted. Compliance with the monthly dosing schedule is important to maintain a constantly active trough serum level of the drug (more than 40 mcg/mL).

PHILADELPHIA — Infants who receive prophylactic palivizumab at home are more likely to get all their doses on time than are those who receive the injections at their pediatrician's office, Dr. Caroline O. Chua reported at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Chua of the Maria Fareri Children's Hospital, Valhalla, N.Y., did a prospective review that included 1,362 infants eligible for respiratory syncytial virus (RSV) prophylaxis during the 2005–2006 RSV season.

Upon discharge from the neonatal intensive care unit, 744 of the infants were scheduled to receive their monthly injections in their pediatricians' offices. The remaining 618 were scheduled to receive the injections at home through the services of a home health care agency.

All of the infants received their first dose of the drug within 24–48 hours of discharge.

But infants scheduled for at-home therapy received significantly more of their scheduled doses on time (95% compliance rate) than did the in-office group (91% compliance rate).

Total hospitalizations, including those secondary to RSV infection, were significantly higher among the in-office group than the in-home group (16 vs. 2). Hospitalizations caused by RSV infections only also were higher in the in-office group, but the difference was not statistically significant (5 vs. 1).

Although the in-office compliance rate leaves something to be desired, it does show a significant improvement from the rate observed in a similar study performed in the same community during the 2001–2002 RSV season, Dr. Chua said.

That study followed 1,446 infants, 969 of whom received their monthly injections at home. The compliance rate was significantly higher than that observed among the 477 who received their injections in the office setting (98% vs. 89%) (Ped. Infect. Dis. 2004;23:318–22).

“We speculate that the increased compliance in offices could be a reflection of better education on the part of pediatricians or media exposure that reached parents,” she said.

The half-life of palivizumab is only 20 days, Dr. Chua noted. Compliance with the monthly dosing schedule is important to maintain a constantly active trough serum level of the drug (more than 40 mcg/mL).

PHILADELPHIA — Infants who receive prophylactic palivizumab at home are more likely to get all their doses on time than are those who receive the injections at their pediatrician's office, Dr. Caroline O. Chua reported at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Chua of the Maria Fareri Children's Hospital, Valhalla, N.Y., did a prospective review that included 1,362 infants eligible for respiratory syncytial virus (RSV) prophylaxis during the 2005–2006 RSV season.

Upon discharge from the neonatal intensive care unit, 744 of the infants were scheduled to receive their monthly injections in their pediatricians' offices. The remaining 618 were scheduled to receive the injections at home through the services of a home health care agency.

All of the infants received their first dose of the drug within 24–48 hours of discharge.

But infants scheduled for at-home therapy received significantly more of their scheduled doses on time (95% compliance rate) than did the in-office group (91% compliance rate).

Total hospitalizations, including those secondary to RSV infection, were significantly higher among the in-office group than the in-home group (16 vs. 2). Hospitalizations caused by RSV infections only also were higher in the in-office group, but the difference was not statistically significant (5 vs. 1).

Although the in-office compliance rate leaves something to be desired, it does show a significant improvement from the rate observed in a similar study performed in the same community during the 2001–2002 RSV season, Dr. Chua said.

That study followed 1,446 infants, 969 of whom received their monthly injections at home. The compliance rate was significantly higher than that observed among the 477 who received their injections in the office setting (98% vs. 89%) (Ped. Infect. Dis. 2004;23:318–22).

“We speculate that the increased compliance in offices could be a reflection of better education on the part of pediatricians or media exposure that reached parents,” she said.

The half-life of palivizumab is only 20 days, Dr. Chua noted. Compliance with the monthly dosing schedule is important to maintain a constantly active trough serum level of the drug (more than 40 mcg/mL).

PHILADELPHIA — Glucose-6-phosphate dehydrogenase deficiency may be a risk factor for necrotizing enterocolitis in infants, Dr. David Schutzman said at the annual meeting of the Eastern Society for Pediatric Research.

He presented a retrospective study of 16 very-low-birth-weight infants with necrotizing enterocolitis of Bell's stage II or greater. The study compared rates of glucose-6-phosphate dehydrogenase (G6PD) deficiency in these infants with rates seen in all babies weighing less than 2 kg admitted to the neonatal intensive care unit over a 16-month period, and to the hospital's entire birth cohort over a 3-month period.

Among the 16 infants with necrotizing enterocolitis, 5 (31%) were G6PD deficient. This was significantly greater than the 9 (5%) that was seen in the NICU cohort of 170 babies weighing less than 2 kg. Having G6PD deficiency conferred an eightfold increase in risk for developing necrotizing enterocolitis, said Dr. Schutzman, chief of neonatology at the Albert Einstein Medical Center, Philadelphia.

The difference was even more pronounced when he compared the group that had necrotizing enterocolitis with the entire birth cohort of 675. The prevalence of G6PD deficiency in the large group was only 4%, with 29 cases; when comparing these two groups, those with the deficiency were at a 10-fold increased risk of developing necrotizing enterocolitis.

“We did not find any significant associations with any maternal factors, such as maternal age, exposure to antenatal steroids or antibiotics, or mode of delivery,” Dr. Schutzman said. There was a nonsignificant association between maternal hypertension and G6PD deficiency.

Similarly, there were no significant associations between the enzyme deficiency and any infant demographics, with one exception: babies with G6PD deficiency were slightly, although not significantly, smaller for gestational age than those without the deficiency.

Dr. Schutzman had previously observed a seeming association between the onset of necrotizing enterocolitis and transfusion. The review showed a nonsignificant association between these factors. However, there were no significant associations between the development of necrotizing enterocolitis and any infant feeding patterns (age at which feeds began, calories consumed, change in feed, or feeding difficulties).

Clinical outcomes for necrotizing enterocolitis were significantly worse among those with G6PD deficiency, he said. All of the 11 infants without the deficiency survived. Three of the five with the deficiency died. “Two had extremely fulminate cases and progressed from the onset of symptoms to death within a few hours. The third had an equally fulminate course and was initially stabilized, but died a few months later due to short gut syndrome.”

A study has shown “black trauma victims with a deficiency had a significantly increased incidence of sepsis compared to nondeficient victims. The G6PD deficiency seems to alter monocyte function and decrease IL-10 response,” he said.

Clinical outcomes for necrotizing enterocolitis were significantly worse among those with G6PD deficiency. DR. SCHUTZMAN

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Glucose-6-phosphate dehydrogenase deficiency may be a risk factor for necrotizing enterocolitis in infants, Dr. David Schutzman said at the annual meeting of the Eastern Society for Pediatric Research.

He presented a retrospective study of 16 very-low-birth-weight infants with necrotizing enterocolitis of Bell's stage II or greater. The study compared rates of glucose-6-phosphate dehydrogenase (G6PD) deficiency in these infants with rates seen in all babies weighing less than 2 kg admitted to the neonatal intensive care unit over a 16-month period, and to the hospital's entire birth cohort over a 3-month period.

Among the 16 infants with necrotizing enterocolitis, 5 (31%) were G6PD deficient. This was significantly greater than the 9 (5%) that was seen in the NICU cohort of 170 babies weighing less than 2 kg. Having G6PD deficiency conferred an eightfold increase in risk for developing necrotizing enterocolitis, said Dr. Schutzman, chief of neonatology at the Albert Einstein Medical Center, Philadelphia.

The difference was even more pronounced when he compared the group that had necrotizing enterocolitis with the entire birth cohort of 675. The prevalence of G6PD deficiency in the large group was only 4%, with 29 cases; when comparing these two groups, those with the deficiency were at a 10-fold increased risk of developing necrotizing enterocolitis.

“We did not find any significant associations with any maternal factors, such as maternal age, exposure to antenatal steroids or antibiotics, or mode of delivery,” Dr. Schutzman said. There was a nonsignificant association between maternal hypertension and G6PD deficiency.

Similarly, there were no significant associations between the enzyme deficiency and any infant demographics, with one exception: babies with G6PD deficiency were slightly, although not significantly, smaller for gestational age than those without the deficiency.

Dr. Schutzman had previously observed a seeming association between the onset of necrotizing enterocolitis and transfusion. The review showed a nonsignificant association between these factors. However, there were no significant associations between the development of necrotizing enterocolitis and any infant feeding patterns (age at which feeds began, calories consumed, change in feed, or feeding difficulties).

Clinical outcomes for necrotizing enterocolitis were significantly worse among those with G6PD deficiency, he said. All of the 11 infants without the deficiency survived. Three of the five with the deficiency died. “Two had extremely fulminate cases and progressed from the onset of symptoms to death within a few hours. The third had an equally fulminate course and was initially stabilized, but died a few months later due to short gut syndrome.”

A study has shown “black trauma victims with a deficiency had a significantly increased incidence of sepsis compared to nondeficient victims. The G6PD deficiency seems to alter monocyte function and decrease IL-10 response,” he said.

Clinical outcomes for necrotizing enterocolitis were significantly worse among those with G6PD deficiency. DR. SCHUTZMAN

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Glucose-6-phosphate dehydrogenase deficiency may be a risk factor for necrotizing enterocolitis in infants, Dr. David Schutzman said at the annual meeting of the Eastern Society for Pediatric Research.

He presented a retrospective study of 16 very-low-birth-weight infants with necrotizing enterocolitis of Bell's stage II or greater. The study compared rates of glucose-6-phosphate dehydrogenase (G6PD) deficiency in these infants with rates seen in all babies weighing less than 2 kg admitted to the neonatal intensive care unit over a 16-month period, and to the hospital's entire birth cohort over a 3-month period.

Among the 16 infants with necrotizing enterocolitis, 5 (31%) were G6PD deficient. This was significantly greater than the 9 (5%) that was seen in the NICU cohort of 170 babies weighing less than 2 kg. Having G6PD deficiency conferred an eightfold increase in risk for developing necrotizing enterocolitis, said Dr. Schutzman, chief of neonatology at the Albert Einstein Medical Center, Philadelphia.

The difference was even more pronounced when he compared the group that had necrotizing enterocolitis with the entire birth cohort of 675. The prevalence of G6PD deficiency in the large group was only 4%, with 29 cases; when comparing these two groups, those with the deficiency were at a 10-fold increased risk of developing necrotizing enterocolitis.

“We did not find any significant associations with any maternal factors, such as maternal age, exposure to antenatal steroids or antibiotics, or mode of delivery,” Dr. Schutzman said. There was a nonsignificant association between maternal hypertension and G6PD deficiency.

Similarly, there were no significant associations between the enzyme deficiency and any infant demographics, with one exception: babies with G6PD deficiency were slightly, although not significantly, smaller for gestational age than those without the deficiency.

Dr. Schutzman had previously observed a seeming association between the onset of necrotizing enterocolitis and transfusion. The review showed a nonsignificant association between these factors. However, there were no significant associations between the development of necrotizing enterocolitis and any infant feeding patterns (age at which feeds began, calories consumed, change in feed, or feeding difficulties).

Clinical outcomes for necrotizing enterocolitis were significantly worse among those with G6PD deficiency, he said. All of the 11 infants without the deficiency survived. Three of the five with the deficiency died. “Two had extremely fulminate cases and progressed from the onset of symptoms to death within a few hours. The third had an equally fulminate course and was initially stabilized, but died a few months later due to short gut syndrome.”

A study has shown “black trauma victims with a deficiency had a significantly increased incidence of sepsis compared to nondeficient victims. The G6PD deficiency seems to alter monocyte function and decrease IL-10 response,” he said.

Clinical outcomes for necrotizing enterocolitis were significantly worse among those with G6PD deficiency. DR. SCHUTZMAN

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Light may soon take a place in the diagnostic and surgical armamentarium for breast cancer.

Researchers at the Technical University of Munich have developed and are currently evaluating the world's first autofluorescence ductoscope, which has the potential to diagnose the earliest forms of intraductal breast cancer and guide surgical treatment.

The instrument combines an autofluorescence light source and camera already approved in Europe for diagnostic bronchoscopy with a 1.3-mm diameter ductoscope. Like autofluorescence bronchoscopy, it operates on the principle that healthy and dysplastic tissues reflect different percentages of light, Dr. Volker R. Jacobs said at a meeting on laparoscopy and minimally invasive surgery.

Light-induced fluorescence bronchoscopy has been used for several years to identify early lung lesions: A helium cadmium blue laser stimulates the lining of the bronchi to autofluoresce in a range of colors. Normal, healthy tissue is shown as being bright green, and suspicious tissue looks reddish-brown. A summary of studies with this technique concluded that it can increase the detection rate of premalignant lesions by up to six times, compared with conventional, white-light bronchoscopy (Lung Cancer 2004;45[suppl. 2]:S29–37).

In 2003, Dr. Jacobs, a research and clinical consultant in obstetrics and gynecology at the university, and Dr. Stefan Paepke began investigating the scientific and clinical potential of autofluorescence ductoscopy for use in small-lumen endoscopy.

The prototype chosen for study uses a 300-W xenon lamp that emits white light; a foot switch adds a blue filter to change it to a fluorescent excitation light. Under this spectrum, healthy tissue shines brightly, reflecting 100% of the light, while dysplastic tissue reflects a reduced amount, or even none, and fades into blackness. However, this picture isn't optimal for diagnostic evaluation, Dr. Jacobs said in an interview. So the investigators inverted the picture so that healthy areas diminish and suspicious areas are highlighted, then overlaid it with an image from the red-violet spectrum to improve detection of potential lesions. In this final image, suspicious areas and potential intraductal lesions appear blue-violet.

The journal Clinical Breast Cancer has accepted Dr. Jacobs' technical feasibility study for publication. In the paper, he describes five patients who were examined intraoperatively with this technique. All had either histologically confirmed ductal carcinoma in situ or papilloma that had been discovered with other imaging methods or fine-needle biopsies.

Diagnostic and autofluorescence ductoscopies were performed before segment or duct excision or lumpectomy. The additional time required for the ductoscopy was minimal, ranging from 5 to 15 minutes, and there were no associated complications. There was no need for intravenous administration of any contrast agent because the procedure uses only light.

The paper notes that areas of suspicion reflected light values distinctly different from those of normal tissue. “The degree of blue-violet color appears to be proportional to the degree of alteration in this tissue, just as it is in bronchoscopy,” Dr. Jacobs said at the meeting sponsored by the Society of Laparoendoscopic Surgeons. “The more light we see, the more dysplastic the tissue should be.”

This observation, if confirmed in prospective trials, could “lead us to be able to intraoperatively differentiate between benign and nonbenign lesions, and maybe even to have semiquantitative visual differentiation that would allow us to make some instant conclusions about the lesion. This could really improve the diagnostic value of the procedure and might even allow earlier therapeutic intervention,” said Dr. Jacobs. “We might also be able to develop this into an early screening procedure for [high-risk] patients.”

Dr. Jacobs hopes to publish a larger case series that will include more data on color gradations, and compare the autofluorescent imaging to standard imaging techniques.

The most immediate application of autofluorescent ductal imaging would probably be surgical, he said. “If we could take a biopsy under autofluorescent visualization, we might be able to use the color as a guide to getting clear margins. This might cut down on the number of R1 resections, and also reduce the need for consecutive operations to ensure clear tumor margins.”

In fact, Dr. Jacobs said, autofluorescent diagnostic ductoscopy would combine very well with interventional ductoscopy. The color gradations would guide the surgeon to the suspicious area, which could be treated endoscopically.

Neither investigator claims a financial interest in either the procedure or the unit.

Dr. Volker R. Jacobs is shown with a display of images obtained on his prototype autofluorescent ductoscopy. Courtesy Dr. Volker R. Jacobs

ORLANDO — Light may soon take a place in the diagnostic and surgical armamentarium for breast cancer.

Researchers at the Technical University of Munich have developed and are currently evaluating the world's first autofluorescence ductoscope, which has the potential to diagnose the earliest forms of intraductal breast cancer and guide surgical treatment.

The instrument combines an autofluorescence light source and camera already approved in Europe for diagnostic bronchoscopy with a 1.3-mm diameter ductoscope. Like autofluorescence bronchoscopy, it operates on the principle that healthy and dysplastic tissues reflect different percentages of light, Dr. Volker R. Jacobs said at a meeting on laparoscopy and minimally invasive surgery.

Light-induced fluorescence bronchoscopy has been used for several years to identify early lung lesions: A helium cadmium blue laser stimulates the lining of the bronchi to autofluoresce in a range of colors. Normal, healthy tissue is shown as being bright green, and suspicious tissue looks reddish-brown. A summary of studies with this technique concluded that it can increase the detection rate of premalignant lesions by up to six times, compared with conventional, white-light bronchoscopy (Lung Cancer 2004;45[suppl. 2]:S29–37).

In 2003, Dr. Jacobs, a research and clinical consultant in obstetrics and gynecology at the university, and Dr. Stefan Paepke began investigating the scientific and clinical potential of autofluorescence ductoscopy for use in small-lumen endoscopy.

The prototype chosen for study uses a 300-W xenon lamp that emits white light; a foot switch adds a blue filter to change it to a fluorescent excitation light. Under this spectrum, healthy tissue shines brightly, reflecting 100% of the light, while dysplastic tissue reflects a reduced amount, or even none, and fades into blackness. However, this picture isn't optimal for diagnostic evaluation, Dr. Jacobs said in an interview. So the investigators inverted the picture so that healthy areas diminish and suspicious areas are highlighted, then overlaid it with an image from the red-violet spectrum to improve detection of potential lesions. In this final image, suspicious areas and potential intraductal lesions appear blue-violet.

The journal Clinical Breast Cancer has accepted Dr. Jacobs' technical feasibility study for publication. In the paper, he describes five patients who were examined intraoperatively with this technique. All had either histologically confirmed ductal carcinoma in situ or papilloma that had been discovered with other imaging methods or fine-needle biopsies.

Diagnostic and autofluorescence ductoscopies were performed before segment or duct excision or lumpectomy. The additional time required for the ductoscopy was minimal, ranging from 5 to 15 minutes, and there were no associated complications. There was no need for intravenous administration of any contrast agent because the procedure uses only light.

The paper notes that areas of suspicion reflected light values distinctly different from those of normal tissue. “The degree of blue-violet color appears to be proportional to the degree of alteration in this tissue, just as it is in bronchoscopy,” Dr. Jacobs said at the meeting sponsored by the Society of Laparoendoscopic Surgeons. “The more light we see, the more dysplastic the tissue should be.”

This observation, if confirmed in prospective trials, could “lead us to be able to intraoperatively differentiate between benign and nonbenign lesions, and maybe even to have semiquantitative visual differentiation that would allow us to make some instant conclusions about the lesion. This could really improve the diagnostic value of the procedure and might even allow earlier therapeutic intervention,” said Dr. Jacobs. “We might also be able to develop this into an early screening procedure for [high-risk] patients.”

Dr. Jacobs hopes to publish a larger case series that will include more data on color gradations, and compare the autofluorescent imaging to standard imaging techniques.

The most immediate application of autofluorescent ductal imaging would probably be surgical, he said. “If we could take a biopsy under autofluorescent visualization, we might be able to use the color as a guide to getting clear margins. This might cut down on the number of R1 resections, and also reduce the need for consecutive operations to ensure clear tumor margins.”

In fact, Dr. Jacobs said, autofluorescent diagnostic ductoscopy would combine very well with interventional ductoscopy. The color gradations would guide the surgeon to the suspicious area, which could be treated endoscopically.

Neither investigator claims a financial interest in either the procedure or the unit.

Dr. Volker R. Jacobs is shown with a display of images obtained on his prototype autofluorescent ductoscopy. Courtesy Dr. Volker R. Jacobs

ORLANDO — Light may soon take a place in the diagnostic and surgical armamentarium for breast cancer.

Researchers at the Technical University of Munich have developed and are currently evaluating the world's first autofluorescence ductoscope, which has the potential to diagnose the earliest forms of intraductal breast cancer and guide surgical treatment.

The instrument combines an autofluorescence light source and camera already approved in Europe for diagnostic bronchoscopy with a 1.3-mm diameter ductoscope. Like autofluorescence bronchoscopy, it operates on the principle that healthy and dysplastic tissues reflect different percentages of light, Dr. Volker R. Jacobs said at a meeting on laparoscopy and minimally invasive surgery.

Light-induced fluorescence bronchoscopy has been used for several years to identify early lung lesions: A helium cadmium blue laser stimulates the lining of the bronchi to autofluoresce in a range of colors. Normal, healthy tissue is shown as being bright green, and suspicious tissue looks reddish-brown. A summary of studies with this technique concluded that it can increase the detection rate of premalignant lesions by up to six times, compared with conventional, white-light bronchoscopy (Lung Cancer 2004;45[suppl. 2]:S29–37).

In 2003, Dr. Jacobs, a research and clinical consultant in obstetrics and gynecology at the university, and Dr. Stefan Paepke began investigating the scientific and clinical potential of autofluorescence ductoscopy for use in small-lumen endoscopy.

The prototype chosen for study uses a 300-W xenon lamp that emits white light; a foot switch adds a blue filter to change it to a fluorescent excitation light. Under this spectrum, healthy tissue shines brightly, reflecting 100% of the light, while dysplastic tissue reflects a reduced amount, or even none, and fades into blackness. However, this picture isn't optimal for diagnostic evaluation, Dr. Jacobs said in an interview. So the investigators inverted the picture so that healthy areas diminish and suspicious areas are highlighted, then overlaid it with an image from the red-violet spectrum to improve detection of potential lesions. In this final image, suspicious areas and potential intraductal lesions appear blue-violet.

The journal Clinical Breast Cancer has accepted Dr. Jacobs' technical feasibility study for publication. In the paper, he describes five patients who were examined intraoperatively with this technique. All had either histologically confirmed ductal carcinoma in situ or papilloma that had been discovered with other imaging methods or fine-needle biopsies.

Diagnostic and autofluorescence ductoscopies were performed before segment or duct excision or lumpectomy. The additional time required for the ductoscopy was minimal, ranging from 5 to 15 minutes, and there were no associated complications. There was no need for intravenous administration of any contrast agent because the procedure uses only light.

The paper notes that areas of suspicion reflected light values distinctly different from those of normal tissue. “The degree of blue-violet color appears to be proportional to the degree of alteration in this tissue, just as it is in bronchoscopy,” Dr. Jacobs said at the meeting sponsored by the Society of Laparoendoscopic Surgeons. “The more light we see, the more dysplastic the tissue should be.”

This observation, if confirmed in prospective trials, could “lead us to be able to intraoperatively differentiate between benign and nonbenign lesions, and maybe even to have semiquantitative visual differentiation that would allow us to make some instant conclusions about the lesion. This could really improve the diagnostic value of the procedure and might even allow earlier therapeutic intervention,” said Dr. Jacobs. “We might also be able to develop this into an early screening procedure for [high-risk] patients.”

Dr. Jacobs hopes to publish a larger case series that will include more data on color gradations, and compare the autofluorescent imaging to standard imaging techniques.

The most immediate application of autofluorescent ductal imaging would probably be surgical, he said. “If we could take a biopsy under autofluorescent visualization, we might be able to use the color as a guide to getting clear margins. This might cut down on the number of R1 resections, and also reduce the need for consecutive operations to ensure clear tumor margins.”

In fact, Dr. Jacobs said, autofluorescent diagnostic ductoscopy would combine very well with interventional ductoscopy. The color gradations would guide the surgeon to the suspicious area, which could be treated endoscopically.

Neither investigator claims a financial interest in either the procedure or the unit.

Dr. Volker R. Jacobs is shown with a display of images obtained on his prototype autofluorescent ductoscopy. Courtesy Dr. Volker R. Jacobs

PHILADELPHIA — Infants who receive prophylactic palivizumab at home are more likely to get all their doses on time than are those who receive the injections at their pediatrician's office, Dr. Caroline O. Chua reported at the annual meeting of the Eastern Society for Pediatric Research.

Children getting the injections at home also had fewer hospitalizations for respiratory syncytial virus (RSV) infections, although the difference was not statistically significant, said Dr. Chua of the Maria Fareri Children's Hospital, Valhalla, N.Y.

Her prospective review included 1,362 infants eligible for RSV prophylaxis during the 2005–2006 RSV season. After discharge from the neonatal intensive care unit, 744 of the infants were scheduled to receive monthly injections in their pediatricians' offices. The remaining 618 were scheduled to receive the injections at home through the services of a home health care agency.

All of the infants received their first dose of the drug within 24–48 hours of discharge. But infants scheduled for at-home therapy received significantly more of their scheduled doses on time (95% compliance rate) than did the in-office group (91% compliance rate). Total hospitalizations, including those secondary to RSV infection, were significantly higher in the in-office group than in the in-home group (16 vs. 2).

Hospitalizations from RSV infections only also were higher in the in-office group, but the difference wasn't statistically significant (5 vs. 1).

Although the in-office compliance rate leaves something to be desired, it shows a significant improvement from the rate observed in a similar study in the same community during the 2001–2002 RSV season, Dr. Chua said. That study followed 1,446 infants, 969 of whom received their monthly injections at home. The compliance rate was significantly higher than that observed among the 477 who received their injections in the office setting (98% vs. 89%) (Ped. Infect. Dis. 2004;23:318–22).

“We speculate that the increased compliance in offices could be a reflection of better education on the part of pediatricians or media exposure that reached parents,” she said.

The half-life of palivizumab is only 20 days, Dr. Chua noted. Compliance with the monthly dosing schedule is important to maintain a constantly active trough serum level of the drug (more than 40 mcg/mL).

Increased compliance in offices could mean better education. DR. CHUA

PHILADELPHIA — Infants who receive prophylactic palivizumab at home are more likely to get all their doses on time than are those who receive the injections at their pediatrician's office, Dr. Caroline O. Chua reported at the annual meeting of the Eastern Society for Pediatric Research.

Children getting the injections at home also had fewer hospitalizations for respiratory syncytial virus (RSV) infections, although the difference was not statistically significant, said Dr. Chua of the Maria Fareri Children's Hospital, Valhalla, N.Y.

Her prospective review included 1,362 infants eligible for RSV prophylaxis during the 2005–2006 RSV season. After discharge from the neonatal intensive care unit, 744 of the infants were scheduled to receive monthly injections in their pediatricians' offices. The remaining 618 were scheduled to receive the injections at home through the services of a home health care agency.

All of the infants received their first dose of the drug within 24–48 hours of discharge. But infants scheduled for at-home therapy received significantly more of their scheduled doses on time (95% compliance rate) than did the in-office group (91% compliance rate). Total hospitalizations, including those secondary to RSV infection, were significantly higher in the in-office group than in the in-home group (16 vs. 2).

Hospitalizations from RSV infections only also were higher in the in-office group, but the difference wasn't statistically significant (5 vs. 1).

Although the in-office compliance rate leaves something to be desired, it shows a significant improvement from the rate observed in a similar study in the same community during the 2001–2002 RSV season, Dr. Chua said. That study followed 1,446 infants, 969 of whom received their monthly injections at home. The compliance rate was significantly higher than that observed among the 477 who received their injections in the office setting (98% vs. 89%) (Ped. Infect. Dis. 2004;23:318–22).

“We speculate that the increased compliance in offices could be a reflection of better education on the part of pediatricians or media exposure that reached parents,” she said.

The half-life of palivizumab is only 20 days, Dr. Chua noted. Compliance with the monthly dosing schedule is important to maintain a constantly active trough serum level of the drug (more than 40 mcg/mL).

Increased compliance in offices could mean better education. DR. CHUA

PHILADELPHIA — Infants who receive prophylactic palivizumab at home are more likely to get all their doses on time than are those who receive the injections at their pediatrician's office, Dr. Caroline O. Chua reported at the annual meeting of the Eastern Society for Pediatric Research.

Children getting the injections at home also had fewer hospitalizations for respiratory syncytial virus (RSV) infections, although the difference was not statistically significant, said Dr. Chua of the Maria Fareri Children's Hospital, Valhalla, N.Y.

Her prospective review included 1,362 infants eligible for RSV prophylaxis during the 2005–2006 RSV season. After discharge from the neonatal intensive care unit, 744 of the infants were scheduled to receive monthly injections in their pediatricians' offices. The remaining 618 were scheduled to receive the injections at home through the services of a home health care agency.

All of the infants received their first dose of the drug within 24–48 hours of discharge. But infants scheduled for at-home therapy received significantly more of their scheduled doses on time (95% compliance rate) than did the in-office group (91% compliance rate). Total hospitalizations, including those secondary to RSV infection, were significantly higher in the in-office group than in the in-home group (16 vs. 2).

Hospitalizations from RSV infections only also were higher in the in-office group, but the difference wasn't statistically significant (5 vs. 1).

Although the in-office compliance rate leaves something to be desired, it shows a significant improvement from the rate observed in a similar study in the same community during the 2001–2002 RSV season, Dr. Chua said. That study followed 1,446 infants, 969 of whom received their monthly injections at home. The compliance rate was significantly higher than that observed among the 477 who received their injections in the office setting (98% vs. 89%) (Ped. Infect. Dis. 2004;23:318–22).

“We speculate that the increased compliance in offices could be a reflection of better education on the part of pediatricians or media exposure that reached parents,” she said.

The half-life of palivizumab is only 20 days, Dr. Chua noted. Compliance with the monthly dosing schedule is important to maintain a constantly active trough serum level of the drug (more than 40 mcg/mL).

Increased compliance in offices could mean better education. DR. CHUA

SAN ANTONIO — Ibandronate seems to be easier on the kidneys than are other bisphosphonates in cancer patients who take the drugs for bone metastases, and may even help normalize renal function in patients whose kidneys declined with zoledronic acid treatment.

The studies, presented at the Sixth International Meeting on Cancer-Induced Bone Disease, suggest that the drug may be living up to its clinical trial promises, Dr. Jörg Seraphin said.

“These data suggest that the renal safety profile of ibandronate in phase III trials transfers to actual clinical practice,” he wrote in a poster at the meeting, which was sponsored by the Cancer and Bone Society.

Dr. Seraphin presented initial results from a 24-week observational study conducted in 157 centers in Germany. The analysis included 913 patients who had breast cancer that had spread to bone.

All of the women received ibandronate, with 88% receiving standard intravenous therapy (6 mg every 2 weeks), 10% receiving oral therapy (50 mg per day), and 2% receiving both IV and oral ibandronate. Most of the patients (549) had not taken any previous bisphosphonates, 93 had previously taken ibandronate, and 271 had previously received other drugs in the class.

Patients had serum creatinine measures taken at baseline and at 24 weeks. Patients and physicians also rated tolerability for both forms of ibandronate.

At baseline, patients who had previously received other bisphosphonates had slightly—but not significantly—higher serum creatinine levels. During treatment, the mean values remained stable among all three groups. However, the maximum creatinine increase in the group previously treated with other bisphosphonates was four times higher (4.2 mg/dL) than the maximum increase in the bisphosphonate-naive or prior-ibandronate groups (1.2 mg/dL and 1 mg/dL, respectively).

“This effect is likely due to the renal toxicity of other bisphosphonates,” wrote Dr. Seraphin, a hematologic oncologist in Northeim, Germany.

Most physicians (98%) and patients (96%) rated ibandronate's tolerability as good or very good. It was also effective in maintaining bone: 90% of patients did not have a fracture during the study.

A retrospective study hinted that switching to ibandronate could help normalize impaired kidney function associated with zoledronic acid treatment in cancer patients with bone metastases. The study—by Dr. Ingo Diel of the Institute for Gynecological Oncology, Mannheim, Germany—included 106 patients. Of these, 72 received ibandronate monotherapy, and 34 were switched to ibandronate from zoledronic acid, most (65%) because of impaired renal function.

The patients' average age was 65 years; most had breast cancer or multiple myeloma. In both treatment groups, the mean baseline serum creatinine level was 1 mg/dL and the mean glomerular filtration rate was 75 mL/min per 1.73 m

Compared with ibandronate-only patients, patients in the switch group were more than seven times as likely to have an increased serum creatinine level, and more than four times as likely to have an impaired glomerular filtration rate.

However, the incidence of these markers of impaired renal function tended to decrease with longer ibandronate treatment, Dr. Diel said. Switching patients showed a significant increase in serum creatinine levels during their zoledronic acid treatment period (1 mg/dL to 1.4 mg/dL), which declined linearly to just over 1 mg/dL by 24 months of ibandronate treatment.

There was a potential survival bias, Dr. Diel noted. “Patients who survived for longer periods were more likely to have better renal function attributable to their overall condition.”

Serum creatinine levels remained stable in the ibandronate-only patients, he added. “Treatment with zoledronic acid may be associated with renal deterioration, which may recover over time when the patient is switched to ibandronate.”

SAN ANTONIO — Ibandronate seems to be easier on the kidneys than are other bisphosphonates in cancer patients who take the drugs for bone metastases, and may even help normalize renal function in patients whose kidneys declined with zoledronic acid treatment.

The studies, presented at the Sixth International Meeting on Cancer-Induced Bone Disease, suggest that the drug may be living up to its clinical trial promises, Dr. Jörg Seraphin said.

“These data suggest that the renal safety profile of ibandronate in phase III trials transfers to actual clinical practice,” he wrote in a poster at the meeting, which was sponsored by the Cancer and Bone Society.

Dr. Seraphin presented initial results from a 24-week observational study conducted in 157 centers in Germany. The analysis included 913 patients who had breast cancer that had spread to bone.

All of the women received ibandronate, with 88% receiving standard intravenous therapy (6 mg every 2 weeks), 10% receiving oral therapy (50 mg per day), and 2% receiving both IV and oral ibandronate. Most of the patients (549) had not taken any previous bisphosphonates, 93 had previously taken ibandronate, and 271 had previously received other drugs in the class.

Patients had serum creatinine measures taken at baseline and at 24 weeks. Patients and physicians also rated tolerability for both forms of ibandronate.

At baseline, patients who had previously received other bisphosphonates had slightly—but not significantly—higher serum creatinine levels. During treatment, the mean values remained stable among all three groups. However, the maximum creatinine increase in the group previously treated with other bisphosphonates was four times higher (4.2 mg/dL) than the maximum increase in the bisphosphonate-naive or prior-ibandronate groups (1.2 mg/dL and 1 mg/dL, respectively).

“This effect is likely due to the renal toxicity of other bisphosphonates,” wrote Dr. Seraphin, a hematologic oncologist in Northeim, Germany.

Most physicians (98%) and patients (96%) rated ibandronate's tolerability as good or very good. It was also effective in maintaining bone: 90% of patients did not have a fracture during the study.

A retrospective study hinted that switching to ibandronate could help normalize impaired kidney function associated with zoledronic acid treatment in cancer patients with bone metastases. The study—by Dr. Ingo Diel of the Institute for Gynecological Oncology, Mannheim, Germany—included 106 patients. Of these, 72 received ibandronate monotherapy, and 34 were switched to ibandronate from zoledronic acid, most (65%) because of impaired renal function.

The patients' average age was 65 years; most had breast cancer or multiple myeloma. In both treatment groups, the mean baseline serum creatinine level was 1 mg/dL and the mean glomerular filtration rate was 75 mL/min per 1.73 m

Compared with ibandronate-only patients, patients in the switch group were more than seven times as likely to have an increased serum creatinine level, and more than four times as likely to have an impaired glomerular filtration rate.

However, the incidence of these markers of impaired renal function tended to decrease with longer ibandronate treatment, Dr. Diel said. Switching patients showed a significant increase in serum creatinine levels during their zoledronic acid treatment period (1 mg/dL to 1.4 mg/dL), which declined linearly to just over 1 mg/dL by 24 months of ibandronate treatment.

There was a potential survival bias, Dr. Diel noted. “Patients who survived for longer periods were more likely to have better renal function attributable to their overall condition.”

Serum creatinine levels remained stable in the ibandronate-only patients, he added. “Treatment with zoledronic acid may be associated with renal deterioration, which may recover over time when the patient is switched to ibandronate.”

SAN ANTONIO — Ibandronate seems to be easier on the kidneys than are other bisphosphonates in cancer patients who take the drugs for bone metastases, and may even help normalize renal function in patients whose kidneys declined with zoledronic acid treatment.

The studies, presented at the Sixth International Meeting on Cancer-Induced Bone Disease, suggest that the drug may be living up to its clinical trial promises, Dr. Jörg Seraphin said.

“These data suggest that the renal safety profile of ibandronate in phase III trials transfers to actual clinical practice,” he wrote in a poster at the meeting, which was sponsored by the Cancer and Bone Society.

Dr. Seraphin presented initial results from a 24-week observational study conducted in 157 centers in Germany. The analysis included 913 patients who had breast cancer that had spread to bone.

All of the women received ibandronate, with 88% receiving standard intravenous therapy (6 mg every 2 weeks), 10% receiving oral therapy (50 mg per day), and 2% receiving both IV and oral ibandronate. Most of the patients (549) had not taken any previous bisphosphonates, 93 had previously taken ibandronate, and 271 had previously received other drugs in the class.

Patients had serum creatinine measures taken at baseline and at 24 weeks. Patients and physicians also rated tolerability for both forms of ibandronate.

At baseline, patients who had previously received other bisphosphonates had slightly—but not significantly—higher serum creatinine levels. During treatment, the mean values remained stable among all three groups. However, the maximum creatinine increase in the group previously treated with other bisphosphonates was four times higher (4.2 mg/dL) than the maximum increase in the bisphosphonate-naive or prior-ibandronate groups (1.2 mg/dL and 1 mg/dL, respectively).

“This effect is likely due to the renal toxicity of other bisphosphonates,” wrote Dr. Seraphin, a hematologic oncologist in Northeim, Germany.

Most physicians (98%) and patients (96%) rated ibandronate's tolerability as good or very good. It was also effective in maintaining bone: 90% of patients did not have a fracture during the study.

A retrospective study hinted that switching to ibandronate could help normalize impaired kidney function associated with zoledronic acid treatment in cancer patients with bone metastases. The study—by Dr. Ingo Diel of the Institute for Gynecological Oncology, Mannheim, Germany—included 106 patients. Of these, 72 received ibandronate monotherapy, and 34 were switched to ibandronate from zoledronic acid, most (65%) because of impaired renal function.

The patients' average age was 65 years; most had breast cancer or multiple myeloma. In both treatment groups, the mean baseline serum creatinine level was 1 mg/dL and the mean glomerular filtration rate was 75 mL/min per 1.73 m

Compared with ibandronate-only patients, patients in the switch group were more than seven times as likely to have an increased serum creatinine level, and more than four times as likely to have an impaired glomerular filtration rate.

However, the incidence of these markers of impaired renal function tended to decrease with longer ibandronate treatment, Dr. Diel said. Switching patients showed a significant increase in serum creatinine levels during their zoledronic acid treatment period (1 mg/dL to 1.4 mg/dL), which declined linearly to just over 1 mg/dL by 24 months of ibandronate treatment.

There was a potential survival bias, Dr. Diel noted. “Patients who survived for longer periods were more likely to have better renal function attributable to their overall condition.”

Serum creatinine levels remained stable in the ibandronate-only patients, he added. “Treatment with zoledronic acid may be associated with renal deterioration, which may recover over time when the patient is switched to ibandronate.”

HOT SPRINGS, VA. — Patients with ovarian cancer who have a hypersensitivity reaction to carboplatin can be successfully treated with cisplatin without a lengthy desensitization procedure, Dr. Megan Callahan said at the annual meeting of the South Atlantic Association of Obstetricians and Gynecologists.

She presented a review of 24 women with ovarian cancer who received cisplatin after an allergic reaction to carboplatin—the largest case series to date.

Carboplatin hypersensitivity is correlated with the number of treatment cycles experienced, said Dr. Callahan of the University of Virginia, Charlottesville. “The cumulative risk increases from 0.92% for less than five cycles to 6.5% for six cycles, and up to 19% for eight cycles,” she said. Her patients' reactions occurred at a median of 10 cycles. None of the reactions were life threatening.

All 24 patients were rechallenged with cisplatin in a subsequent treatment cycle. The drug was given at a standard infusion rate over 1.5 hours. None of the patients received desensitization with steroids or antihistamines.

Most (18) were able to tolerate the full number of cisplatin treatment cycles without a hypersensitivity reaction. Of the six who did react to cisplatin, only one did so in the first cycle. The rest were able to tolerate one to six cycles before having a reaction. All of the cisplatin reactions were managed conservatively on an outpatient basis, and none of the reactions were life threatening.

Dr. Callahan's 24 patients bring the total reported in the literature to 57. Among these patients, only seven had cisplatin reactions; one died. “This results in an 86% success rate for cisplatin rechallenge,” Dr. Callahan said.

Unfortunately, she added, she has been unable to identify any predisposing factors that might predict which patients would react to either drug. “We looked at past medical history, reported allergies, and concurrent medications, and we couldn't identify anything that would predispose them to a reaction.” Nor did the severity of the initial carboplatin reaction predict which patients would later experience a cisplatin reaction, she said.

HOT SPRINGS, VA. — Patients with ovarian cancer who have a hypersensitivity reaction to carboplatin can be successfully treated with cisplatin without a lengthy desensitization procedure, Dr. Megan Callahan said at the annual meeting of the South Atlantic Association of Obstetricians and Gynecologists.

She presented a review of 24 women with ovarian cancer who received cisplatin after an allergic reaction to carboplatin—the largest case series to date.

Carboplatin hypersensitivity is correlated with the number of treatment cycles experienced, said Dr. Callahan of the University of Virginia, Charlottesville. “The cumulative risk increases from 0.92% for less than five cycles to 6.5% for six cycles, and up to 19% for eight cycles,” she said. Her patients' reactions occurred at a median of 10 cycles. None of the reactions were life threatening.

All 24 patients were rechallenged with cisplatin in a subsequent treatment cycle. The drug was given at a standard infusion rate over 1.5 hours. None of the patients received desensitization with steroids or antihistamines.

Most (18) were able to tolerate the full number of cisplatin treatment cycles without a hypersensitivity reaction. Of the six who did react to cisplatin, only one did so in the first cycle. The rest were able to tolerate one to six cycles before having a reaction. All of the cisplatin reactions were managed conservatively on an outpatient basis, and none of the reactions were life threatening.

Dr. Callahan's 24 patients bring the total reported in the literature to 57. Among these patients, only seven had cisplatin reactions; one died. “This results in an 86% success rate for cisplatin rechallenge,” Dr. Callahan said.

Unfortunately, she added, she has been unable to identify any predisposing factors that might predict which patients would react to either drug. “We looked at past medical history, reported allergies, and concurrent medications, and we couldn't identify anything that would predispose them to a reaction.” Nor did the severity of the initial carboplatin reaction predict which patients would later experience a cisplatin reaction, she said.

HOT SPRINGS, VA. — Patients with ovarian cancer who have a hypersensitivity reaction to carboplatin can be successfully treated with cisplatin without a lengthy desensitization procedure, Dr. Megan Callahan said at the annual meeting of the South Atlantic Association of Obstetricians and Gynecologists.

She presented a review of 24 women with ovarian cancer who received cisplatin after an allergic reaction to carboplatin—the largest case series to date.

Carboplatin hypersensitivity is correlated with the number of treatment cycles experienced, said Dr. Callahan of the University of Virginia, Charlottesville. “The cumulative risk increases from 0.92% for less than five cycles to 6.5% for six cycles, and up to 19% for eight cycles,” she said. Her patients' reactions occurred at a median of 10 cycles. None of the reactions were life threatening.

All 24 patients were rechallenged with cisplatin in a subsequent treatment cycle. The drug was given at a standard infusion rate over 1.5 hours. None of the patients received desensitization with steroids or antihistamines.

Most (18) were able to tolerate the full number of cisplatin treatment cycles without a hypersensitivity reaction. Of the six who did react to cisplatin, only one did so in the first cycle. The rest were able to tolerate one to six cycles before having a reaction. All of the cisplatin reactions were managed conservatively on an outpatient basis, and none of the reactions were life threatening.

Dr. Callahan's 24 patients bring the total reported in the literature to 57. Among these patients, only seven had cisplatin reactions; one died. “This results in an 86% success rate for cisplatin rechallenge,” Dr. Callahan said.

Unfortunately, she added, she has been unable to identify any predisposing factors that might predict which patients would react to either drug. “We looked at past medical history, reported allergies, and concurrent medications, and we couldn't identify anything that would predispose them to a reaction.” Nor did the severity of the initial carboplatin reaction predict which patients would later experience a cisplatin reaction, she said.