Mary Ann Moon

Children who attend large day-care programs before age 2 1/2 years show a short-term increase in the number of infections they acquire but are protected against infections during the elementary school years, according to a report in the Archives of Pediatrics and Adolescent Medicine.

© lostinbids/istock.com

“This study provides reassuring evidence for parents that their choices regarding child care (group size and age at enrollment) should not have a major effect on the health of their children from a long-term perspective, at least regarding respiratory tract infections, gastrointestinal tract infections, and ear infections,” said Sylvana M. Côté, Ph.D., of the department of social and preventive medicine, Ste-Justine Hospital, Montreal, and her associates.

“Physicians may reassure parents whose children initiate large group child care early that their child’s experiencing infections is temporary and is likely to provide them with greater immunity during the elementary school years,” they noted.

Dr. Côté and her colleagues performed what they described as the first prospective, population-based study to examine the associations between different day-care experiences and three types of infections from early preschool age through mid-elementary school age. They used data from the Quebec Longitudinal Study of Child Development to follow a representative sample of 1,238 study subjects every year from 5 months of age in 1998 through 8 years of age in 2006.

The researchers statistically controlled for potentially confounding variables such as maternal education level, maternal health status, low birth weight, breast feeding status, ethnicity, and family size.

In all, 244 children (approximately 20%) were cared for at home and did not attend day care of any size before enrolling in school. An additional 402 children (32%) attended a small, home-based day-care program for three to eight children younger than age 2 1/2, while 249 (20%) attended a large day-care program (up to 10 groups of 8-12 children per “class”) before age 2 1/2. The remaining children attended either small or large day-care programs after age 2 1/2.

Compared with home-cared children, those who started large day-care programs early in their preschool years had higher rates of respiratory and ear infections around the time they enrolled. However, they did not have higher rates of respiratory and ear infections at ages 3-4. More important, they had lower rates of such infections during the elementary school years, a time “when absenteeism carries more important consequences,” the investigators said (Arch. Pediatr. Adolesc. Med. 2010;164:1132-7).

Children who started large day-care programs later in their preschool years had higher rates of respiratory and ear infections at that time, but did not differ from home-cared children at any other time.

Children who started small day-care programs in either their early preschool years or late preschool years did not differ from home-cared children at any time. It thus appears that large day-care programs protect against future infections while small programs do not, perhaps because the large programs “provide exposure to a larger number of serotypes (and infectious agents) and … this wider exposure is necessary for preschoolers to acquire immunity,” Dr. Côté and her associates said.

Day care was not associated with gastrointestinal infections at any developmental period.

When the data were analyzed across the entire study period up to age 8 years, there was no difference in the overall number of infections between children who attended only home care before elementary school and children who attended either type of day care before elementary school.

This study was supported by the government of Quebec, Fondation Chagnon, Fond Québécois de la Recherche sur la Société et la Culture, Fonds pour la Recherche en Santé du Québec, Social Science and Humanities Research Council of Canada, Canadian Institutes for Health Research, Sainte-Justine Hospital’s Research Center, and the University of Montreal. No financial conflicts of interest were reported.

Children who attend large day-care programs before age 2 1/2 years show a short-term increase in the number of infections they acquire but are protected against infections during the elementary school years, according to a report in the Archives of Pediatrics and Adolescent Medicine.

© lostinbids/istock.com

“This study provides reassuring evidence for parents that their choices regarding child care (group size and age at enrollment) should not have a major effect on the health of their children from a long-term perspective, at least regarding respiratory tract infections, gastrointestinal tract infections, and ear infections,” said Sylvana M. Côté, Ph.D., of the department of social and preventive medicine, Ste-Justine Hospital, Montreal, and her associates.

“Physicians may reassure parents whose children initiate large group child care early that their child’s experiencing infections is temporary and is likely to provide them with greater immunity during the elementary school years,” they noted.

Dr. Côté and her colleagues performed what they described as the first prospective, population-based study to examine the associations between different day-care experiences and three types of infections from early preschool age through mid-elementary school age. They used data from the Quebec Longitudinal Study of Child Development to follow a representative sample of 1,238 study subjects every year from 5 months of age in 1998 through 8 years of age in 2006.

The researchers statistically controlled for potentially confounding variables such as maternal education level, maternal health status, low birth weight, breast feeding status, ethnicity, and family size.

In all, 244 children (approximately 20%) were cared for at home and did not attend day care of any size before enrolling in school. An additional 402 children (32%) attended a small, home-based day-care program for three to eight children younger than age 2 1/2, while 249 (20%) attended a large day-care program (up to 10 groups of 8-12 children per “class”) before age 2 1/2. The remaining children attended either small or large day-care programs after age 2 1/2.

Compared with home-cared children, those who started large day-care programs early in their preschool years had higher rates of respiratory and ear infections around the time they enrolled. However, they did not have higher rates of respiratory and ear infections at ages 3-4. More important, they had lower rates of such infections during the elementary school years, a time “when absenteeism carries more important consequences,” the investigators said (Arch. Pediatr. Adolesc. Med. 2010;164:1132-7).

Children who started large day-care programs later in their preschool years had higher rates of respiratory and ear infections at that time, but did not differ from home-cared children at any other time.

Children who started small day-care programs in either their early preschool years or late preschool years did not differ from home-cared children at any time. It thus appears that large day-care programs protect against future infections while small programs do not, perhaps because the large programs “provide exposure to a larger number of serotypes (and infectious agents) and … this wider exposure is necessary for preschoolers to acquire immunity,” Dr. Côté and her associates said.

Day care was not associated with gastrointestinal infections at any developmental period.

When the data were analyzed across the entire study period up to age 8 years, there was no difference in the overall number of infections between children who attended only home care before elementary school and children who attended either type of day care before elementary school.

This study was supported by the government of Quebec, Fondation Chagnon, Fond Québécois de la Recherche sur la Société et la Culture, Fonds pour la Recherche en Santé du Québec, Social Science and Humanities Research Council of Canada, Canadian Institutes for Health Research, Sainte-Justine Hospital’s Research Center, and the University of Montreal. No financial conflicts of interest were reported.

Children who attend large day-care programs before age 2 1/2 years show a short-term increase in the number of infections they acquire but are protected against infections during the elementary school years, according to a report in the Archives of Pediatrics and Adolescent Medicine.

© lostinbids/istock.com

“This study provides reassuring evidence for parents that their choices regarding child care (group size and age at enrollment) should not have a major effect on the health of their children from a long-term perspective, at least regarding respiratory tract infections, gastrointestinal tract infections, and ear infections,” said Sylvana M. Côté, Ph.D., of the department of social and preventive medicine, Ste-Justine Hospital, Montreal, and her associates.

“Physicians may reassure parents whose children initiate large group child care early that their child’s experiencing infections is temporary and is likely to provide them with greater immunity during the elementary school years,” they noted.

Dr. Côté and her colleagues performed what they described as the first prospective, population-based study to examine the associations between different day-care experiences and three types of infections from early preschool age through mid-elementary school age. They used data from the Quebec Longitudinal Study of Child Development to follow a representative sample of 1,238 study subjects every year from 5 months of age in 1998 through 8 years of age in 2006.

The researchers statistically controlled for potentially confounding variables such as maternal education level, maternal health status, low birth weight, breast feeding status, ethnicity, and family size.

In all, 244 children (approximately 20%) were cared for at home and did not attend day care of any size before enrolling in school. An additional 402 children (32%) attended a small, home-based day-care program for three to eight children younger than age 2 1/2, while 249 (20%) attended a large day-care program (up to 10 groups of 8-12 children per “class”) before age 2 1/2. The remaining children attended either small or large day-care programs after age 2 1/2.

Compared with home-cared children, those who started large day-care programs early in their preschool years had higher rates of respiratory and ear infections around the time they enrolled. However, they did not have higher rates of respiratory and ear infections at ages 3-4. More important, they had lower rates of such infections during the elementary school years, a time “when absenteeism carries more important consequences,” the investigators said (Arch. Pediatr. Adolesc. Med. 2010;164:1132-7).

Children who started large day-care programs later in their preschool years had higher rates of respiratory and ear infections at that time, but did not differ from home-cared children at any other time.

Children who started small day-care programs in either their early preschool years or late preschool years did not differ from home-cared children at any time. It thus appears that large day-care programs protect against future infections while small programs do not, perhaps because the large programs “provide exposure to a larger number of serotypes (and infectious agents) and … this wider exposure is necessary for preschoolers to acquire immunity,” Dr. Côté and her associates said.

Day care was not associated with gastrointestinal infections at any developmental period.

When the data were analyzed across the entire study period up to age 8 years, there was no difference in the overall number of infections between children who attended only home care before elementary school and children who attended either type of day care before elementary school.

This study was supported by the government of Quebec, Fondation Chagnon, Fond Québécois de la Recherche sur la Société et la Culture, Fonds pour la Recherche en Santé du Québec, Social Science and Humanities Research Council of Canada, Canadian Institutes for Health Research, Sainte-Justine Hospital’s Research Center, and the University of Montreal. No financial conflicts of interest were reported.

Children who attend large day-care programs before age 2 1/2 years show a short-term increase in the number of infections they acquire but are protected against infections during the elementary school years, according to a report in the Archives of Pediatrics and Adolescent Medicine.

© lostinbids/istock.com

“This study provides reassuring evidence for parents that their choices regarding child care (group size and age at enrollment) should not have a major effect on the health of their children from a long-term perspective, at least regarding respiratory tract infections, gastrointestinal tract infections, and ear infections,” said Sylvana M. Côté, Ph.D., of the department of social and preventive medicine, Ste-Justine Hospital, Montreal, and her associates.

“Physicians may reassure parents whose children initiate large group child care early that their child’s experiencing infections is temporary and is likely to provide them with greater immunity during the elementary school years,” they noted.

Dr. Côté and her colleagues performed what they described as the first prospective, population-based study to examine the associations between different day-care experiences and three types of infections from early preschool age through mid-elementary school age. They used data from the Quebec Longitudinal Study of Child Development to follow a representative sample of 1,238 study subjects every year from 5 months of age in 1998 through 8 years of age in 2006.

The researchers statistically controlled for potentially confounding variables such as maternal education level, maternal health status, low birth weight, breast feeding status, ethnicity, and family size.

In all, 244 children (approximately 20%) were cared for at home and did not attend day care of any size before enrolling in school. An additional 402 children (32%) attended a small, home-based day-care program for three to eight children younger than age 2 1/2, while 249 (20%) attended a large day-care program (up to 10 groups of 8-12 children per “class”) before age 2 1/2. The remaining children attended either small or large day-care programs after age 2 1/2.

Compared with home-cared children, those who started large day-care programs early in their preschool years had higher rates of respiratory and ear infections around the time they enrolled. However, they did not have higher rates of respiratory and ear infections at ages 3-4. More important, they had lower rates of such infections during the elementary school years, a time “when absenteeism carries more important consequences,” the investigators said (Arch. Pediatr. Adolesc. Med. 2010;164:1132-7).

Children who started large day-care programs later in their preschool years had higher rates of respiratory and ear infections at that time, but did not differ from home-cared children at any other time.

Children who started small day-care programs in either their early preschool years or late preschool years did not differ from home-cared children at any time. It thus appears that large day-care programs protect against future infections while small programs do not, perhaps because the large programs “provide exposure to a larger number of serotypes (and infectious agents) and … this wider exposure is necessary for preschoolers to acquire immunity,” Dr. Côté and her associates said.

Day care was not associated with gastrointestinal infections at any developmental period.

When the data were analyzed across the entire study period up to age 8 years, there was no difference in the overall number of infections between children who attended only home care before elementary school and children who attended either type of day care before elementary school.

This study was supported by the government of Quebec, Fondation Chagnon, Fond Québécois de la Recherche sur la Société et la Culture, Fonds pour la Recherche en Santé du Québec, Social Science and Humanities Research Council of Canada, Canadian Institutes for Health Research, Sainte-Justine Hospital’s Research Center, and the University of Montreal. No financial conflicts of interest were reported.

Children who attend large day-care programs before age 2 1/2 years show a short-term increase in the number of infections they acquire but are protected against infections during the elementary school years, according to a report in the Archives of Pediatrics and Adolescent Medicine.

© lostinbids/istock.com

“This study provides reassuring evidence for parents that their choices regarding child care (group size and age at enrollment) should not have a major effect on the health of their children from a long-term perspective, at least regarding respiratory tract infections, gastrointestinal tract infections, and ear infections,” said Sylvana M. Côté, Ph.D., of the department of social and preventive medicine, Ste-Justine Hospital, Montreal, and her associates.

“Physicians may reassure parents whose children initiate large group child care early that their child’s experiencing infections is temporary and is likely to provide them with greater immunity during the elementary school years,” they noted.

Dr. Côté and her colleagues performed what they described as the first prospective, population-based study to examine the associations between different day-care experiences and three types of infections from early preschool age through mid-elementary school age. They used data from the Quebec Longitudinal Study of Child Development to follow a representative sample of 1,238 study subjects every year from 5 months of age in 1998 through 8 years of age in 2006.

The researchers statistically controlled for potentially confounding variables such as maternal education level, maternal health status, low birth weight, breast feeding status, ethnicity, and family size.

In all, 244 children (approximately 20%) were cared for at home and did not attend day care of any size before enrolling in school. An additional 402 children (32%) attended a small, home-based day-care program for three to eight children younger than age 2 1/2, while 249 (20%) attended a large day-care program (up to 10 groups of 8-12 children per “class”) before age 2 1/2. The remaining children attended either small or large day-care programs after age 2 1/2.

Compared with home-cared children, those who started large day-care programs early in their preschool years had higher rates of respiratory and ear infections around the time they enrolled. However, they did not have higher rates of respiratory and ear infections at ages 3-4. More important, they had lower rates of such infections during the elementary school years, a time “when absenteeism carries more important consequences,” the investigators said (Arch. Pediatr. Adolesc. Med. 2010;164:1132-7).

Children who started large day-care programs later in their preschool years had higher rates of respiratory and ear infections at that time, but did not differ from home-cared children at any other time.

Children who started small day-care programs in either their early preschool years or late preschool years did not differ from home-cared children at any time. It thus appears that large day-care programs protect against future infections while small programs do not, perhaps because the large programs “provide exposure to a larger number of serotypes (and infectious agents) and … this wider exposure is necessary for preschoolers to acquire immunity,” Dr. Côté and her associates said.

Day care was not associated with gastrointestinal infections at any developmental period.

When the data were analyzed across the entire study period up to age 8 years, there was no difference in the overall number of infections between children who attended only home care before elementary school and children who attended either type of day care before elementary school.

This study was supported by the government of Quebec, Fondation Chagnon, Fond Québécois de la Recherche sur la Société et la Culture, Fonds pour la Recherche en Santé du Québec, Social Science and Humanities Research Council of Canada, Canadian Institutes for Health Research, Sainte-Justine Hospital’s Research Center, and the University of Montreal. No financial conflicts of interest were reported.

Children who attend large day-care programs before age 2 1/2 years show a short-term increase in the number of infections they acquire but are protected against infections during the elementary school years, according to a report in the Archives of Pediatrics and Adolescent Medicine.

© lostinbids/istock.com

“This study provides reassuring evidence for parents that their choices regarding child care (group size and age at enrollment) should not have a major effect on the health of their children from a long-term perspective, at least regarding respiratory tract infections, gastrointestinal tract infections, and ear infections,” said Sylvana M. Côté, Ph.D., of the department of social and preventive medicine, Ste-Justine Hospital, Montreal, and her associates.

“Physicians may reassure parents whose children initiate large group child care early that their child’s experiencing infections is temporary and is likely to provide them with greater immunity during the elementary school years,” they noted.

Dr. Côté and her colleagues performed what they described as the first prospective, population-based study to examine the associations between different day-care experiences and three types of infections from early preschool age through mid-elementary school age. They used data from the Quebec Longitudinal Study of Child Development to follow a representative sample of 1,238 study subjects every year from 5 months of age in 1998 through 8 years of age in 2006.

The researchers statistically controlled for potentially confounding variables such as maternal education level, maternal health status, low birth weight, breast feeding status, ethnicity, and family size.

In all, 244 children (approximately 20%) were cared for at home and did not attend day care of any size before enrolling in school. An additional 402 children (32%) attended a small, home-based day-care program for three to eight children younger than age 2 1/2, while 249 (20%) attended a large day-care program (up to 10 groups of 8-12 children per “class”) before age 2 1/2. The remaining children attended either small or large day-care programs after age 2 1/2.

Compared with home-cared children, those who started large day-care programs early in their preschool years had higher rates of respiratory and ear infections around the time they enrolled. However, they did not have higher rates of respiratory and ear infections at ages 3-4. More important, they had lower rates of such infections during the elementary school years, a time “when absenteeism carries more important consequences,” the investigators said (Arch. Pediatr. Adolesc. Med. 2010;164:1132-7).

Children who started large day-care programs later in their preschool years had higher rates of respiratory and ear infections at that time, but did not differ from home-cared children at any other time.

Children who started small day-care programs in either their early preschool years or late preschool years did not differ from home-cared children at any time. It thus appears that large day-care programs protect against future infections while small programs do not, perhaps because the large programs “provide exposure to a larger number of serotypes (and infectious agents) and … this wider exposure is necessary for preschoolers to acquire immunity,” Dr. Côté and her associates said.

Day care was not associated with gastrointestinal infections at any developmental period.

When the data were analyzed across the entire study period up to age 8 years, there was no difference in the overall number of infections between children who attended only home care before elementary school and children who attended either type of day care before elementary school.

This study was supported by the government of Quebec, Fondation Chagnon, Fond Québécois de la Recherche sur la Société et la Culture, Fonds pour la Recherche en Santé du Québec, Social Science and Humanities Research Council of Canada, Canadian Institutes for Health Research, Sainte-Justine Hospital’s Research Center, and the University of Montreal. No financial conflicts of interest were reported.

Regular use of sunscreen during a clinical trial of basal cell and squamous cell carcinomas was found to reduce the incidence of a different skin malignancy – new primary melanomas – up to 10 years later, according to a study published online Dec. 6 in the Journal of Clinical Oncology.

The number of invasive melanomas in particular decreased by 73%, but this was an exploratory finding "and should be interpreted cautiously," said Dr. Adéle C. Green and her associates at the Queensland Institute of Medical Research, Royal Brisbane (Australia) Hospital.

Photo copyright mark wragg/iStockphoto.com

The original clinical trial, conducted in 1992-1996 and involving 1,621 white Queensland residents aged 25-75 years at baseline, examined the effects of 5 years of sunscreen application and beta-carotene supplementation on the incidence of basal and squamous cell carcinoma.

Dr. Green and her colleagues new report focuses on the incidence of melanoma as a secondary end point in the same study population. "Despite the known etiologic role of sun exposure, the question regarding sunscreen use to prevent melanoma remains open and controversial," they noted.

During the trial, 812 patients were given a free, unlimited supply of SPF-16 sunscreen and instructed to use it daily on their head, neck, arms, and hands. A comparison group of 809 patients was randomly assigned to continue using sunscreen of any SPF at their own discretion, which included no use at all in 38% and infrequent use in another 35%.

The two groups were similar in established risk factors for skin cancer, degree of sun exposure, and use of sun protection measures other than sunscreen.

Between baseline in 1992 and the end of the extended follow-up in 2006, 36 study patients developed first primary melanomas. These were in-situ malignancies in 22 subjects and invasive in 14; none of the melanomas was metastatic. Three patients who had melanoma diagnosed in 1992 were excluded.

Only 11 subjects in the sunscreen group developed melanoma, compared with 22 in the comparison group. "Risk of melanoma overall was reduced in those randomly assigned to daily sunscreen compared with discretionary use, although the result was of borderline statistical significance," the investigators reported (J. Clin. Oncol. 2010 [doi:10.1200/JCO.2010.28.7078]).

The average melanoma thickness was 0.53 mm in the sunscreen group, compared with 1.2 mm in the comparison group. The incidence of invasive melanoma was decreased by 73% with sunscreen, while the incidence of in situ lesions was not significantly different between the two groups.

Melanoma incidence was decreased at all sites on the body, not just on the sites assigned to protection by sunscreen. This is probably because many study patients in the sunscreen group applied sunscreen to their trunks and lower limbs regularly, even though they had not been instructed to do so, Dr. Green and her associates noted.

"Our findings provide reassurance in view of the widespread uncertainty to date about sunscreen's ability to prevent melanoma," they reported.

"Although the results are directly relevant to people who live in sunny climates like Australia’s and who receive relatively high levels of ambient sun exposure as a matter of course, they also have implications for white people living in temperate climates in North America and Europe who are at increased risk of melanoma because of increased solar UV exposure caused by the predilection for holidays in sunny places," they concluded.

Regular use of sunscreen during a clinical trial of basal cell and squamous cell carcinomas was found to reduce the incidence of a different skin malignancy – new primary melanomas – up to 10 years later, according to a study published online Dec. 6 in the Journal of Clinical Oncology.

The number of invasive melanomas in particular decreased by 73%, but this was an exploratory finding "and should be interpreted cautiously," said Dr. Adéle C. Green and her associates at the Queensland Institute of Medical Research, Royal Brisbane (Australia) Hospital.

Photo copyright mark wragg/iStockphoto.com

The original clinical trial, conducted in 1992-1996 and involving 1,621 white Queensland residents aged 25-75 years at baseline, examined the effects of 5 years of sunscreen application and beta-carotene supplementation on the incidence of basal and squamous cell carcinoma.

Dr. Green and her colleagues new report focuses on the incidence of melanoma as a secondary end point in the same study population. "Despite the known etiologic role of sun exposure, the question regarding sunscreen use to prevent melanoma remains open and controversial," they noted.

During the trial, 812 patients were given a free, unlimited supply of SPF-16 sunscreen and instructed to use it daily on their head, neck, arms, and hands. A comparison group of 809 patients was randomly assigned to continue using sunscreen of any SPF at their own discretion, which included no use at all in 38% and infrequent use in another 35%.

The two groups were similar in established risk factors for skin cancer, degree of sun exposure, and use of sun protection measures other than sunscreen.

Between baseline in 1992 and the end of the extended follow-up in 2006, 36 study patients developed first primary melanomas. These were in-situ malignancies in 22 subjects and invasive in 14; none of the melanomas was metastatic. Three patients who had melanoma diagnosed in 1992 were excluded.

Only 11 subjects in the sunscreen group developed melanoma, compared with 22 in the comparison group. "Risk of melanoma overall was reduced in those randomly assigned to daily sunscreen compared with discretionary use, although the result was of borderline statistical significance," the investigators reported (J. Clin. Oncol. 2010 [doi:10.1200/JCO.2010.28.7078]).

The average melanoma thickness was 0.53 mm in the sunscreen group, compared with 1.2 mm in the comparison group. The incidence of invasive melanoma was decreased by 73% with sunscreen, while the incidence of in situ lesions was not significantly different between the two groups.

Melanoma incidence was decreased at all sites on the body, not just on the sites assigned to protection by sunscreen. This is probably because many study patients in the sunscreen group applied sunscreen to their trunks and lower limbs regularly, even though they had not been instructed to do so, Dr. Green and her associates noted.

"Our findings provide reassurance in view of the widespread uncertainty to date about sunscreen's ability to prevent melanoma," they reported.

"Although the results are directly relevant to people who live in sunny climates like Australia’s and who receive relatively high levels of ambient sun exposure as a matter of course, they also have implications for white people living in temperate climates in North America and Europe who are at increased risk of melanoma because of increased solar UV exposure caused by the predilection for holidays in sunny places," they concluded.

Regular use of sunscreen during a clinical trial of basal cell and squamous cell carcinomas was found to reduce the incidence of a different skin malignancy – new primary melanomas – up to 10 years later, according to a study published online Dec. 6 in the Journal of Clinical Oncology.

The number of invasive melanomas in particular decreased by 73%, but this was an exploratory finding "and should be interpreted cautiously," said Dr. Adéle C. Green and her associates at the Queensland Institute of Medical Research, Royal Brisbane (Australia) Hospital.

Photo copyright mark wragg/iStockphoto.com

The original clinical trial, conducted in 1992-1996 and involving 1,621 white Queensland residents aged 25-75 years at baseline, examined the effects of 5 years of sunscreen application and beta-carotene supplementation on the incidence of basal and squamous cell carcinoma.

Dr. Green and her colleagues new report focuses on the incidence of melanoma as a secondary end point in the same study population. "Despite the known etiologic role of sun exposure, the question regarding sunscreen use to prevent melanoma remains open and controversial," they noted.

During the trial, 812 patients were given a free, unlimited supply of SPF-16 sunscreen and instructed to use it daily on their head, neck, arms, and hands. A comparison group of 809 patients was randomly assigned to continue using sunscreen of any SPF at their own discretion, which included no use at all in 38% and infrequent use in another 35%.

The two groups were similar in established risk factors for skin cancer, degree of sun exposure, and use of sun protection measures other than sunscreen.

Between baseline in 1992 and the end of the extended follow-up in 2006, 36 study patients developed first primary melanomas. These were in-situ malignancies in 22 subjects and invasive in 14; none of the melanomas was metastatic. Three patients who had melanoma diagnosed in 1992 were excluded.

Only 11 subjects in the sunscreen group developed melanoma, compared with 22 in the comparison group. "Risk of melanoma overall was reduced in those randomly assigned to daily sunscreen compared with discretionary use, although the result was of borderline statistical significance," the investigators reported (J. Clin. Oncol. 2010 [doi:10.1200/JCO.2010.28.7078]).

The average melanoma thickness was 0.53 mm in the sunscreen group, compared with 1.2 mm in the comparison group. The incidence of invasive melanoma was decreased by 73% with sunscreen, while the incidence of in situ lesions was not significantly different between the two groups.

Melanoma incidence was decreased at all sites on the body, not just on the sites assigned to protection by sunscreen. This is probably because many study patients in the sunscreen group applied sunscreen to their trunks and lower limbs regularly, even though they had not been instructed to do so, Dr. Green and her associates noted.

"Our findings provide reassurance in view of the widespread uncertainty to date about sunscreen's ability to prevent melanoma," they reported.

"Although the results are directly relevant to people who live in sunny climates like Australia’s and who receive relatively high levels of ambient sun exposure as a matter of course, they also have implications for white people living in temperate climates in North America and Europe who are at increased risk of melanoma because of increased solar UV exposure caused by the predilection for holidays in sunny places," they concluded.

Regular use of sunscreen during a clinical trial of basal cell and squamous cell carcinomas was found to reduce the incidence of a different skin malignancy – new primary melanomas – up to 10 years later, according to a study published online Dec. 6 in the Journal of Clinical Oncology.

The number of invasive melanomas in particular decreased by 73%, but this was an exploratory finding "and should be interpreted cautiously," said Dr. Adéle C. Green and her associates at the Queensland Institute of Medical Research, Royal Brisbane (Australia) Hospital.

© mark wragg/iStockphoto.com

The original clinical trial, conducted in 1992-1996 and involving 1,621 white Queensland residents aged 25-75 years at baseline, examined the effects of 5 years of sunscreen application and beta-carotene supplementation on the incidence of basal and squamous cell carcinoma.

Dr. Green and her colleagues new report focuses on the incidence of melanoma as a secondary end point in the same study population. "Despite the known etiologic role of sun exposure, the question regarding sunscreen use to prevent melanoma remains open and controversial," they noted.

During the trial, 812 patients were given a free, unlimited supply of SPF-16 sunscreen and instructed to use it daily on their head, neck, arms, and hands. A comparison group of 809 patients was randomly assigned to continue using sunscreen of any SPF at their own discretion, which included no use at all in 38% and infrequent use in another 35%.

The two groups were similar in established risk factors for skin cancer, degree of sun exposure, and use of sun protection measures other than sunscreen.

Between baseline in 1992 and the end of the extended follow-up in 2006, 36 study patients developed first primary melanomas. These were in-situ malignancies in 22 subjects and invasive in 14; none of the melanomas was metastatic. Three patients who had melanoma diagnosed in 1992 were excluded.

Only 11 subjects in the sunscreen group developed melanoma, compared with 22 in the comparison group. "Risk of melanoma overall was reduced in those randomly assigned to daily sunscreen compared with discretionary use, although the result was of borderline statistical significance," the investigators reported (J. Clin. Oncol. 2010 [doi:10.1200/JCO.2010.28.7078]).

The average melanoma thickness was 0.53 mm in the sunscreen group, compared with 1.2 mm in the comparison group. The incidence of invasive melanoma was decreased by 73% with sunscreen, while the incidence of in situ lesions was not significantly different between the two groups.

Melanoma incidence was decreased at all sites on the body, not just on the sites assigned to protection by sunscreen. This is probably because many study patients in the sunscreen group applied sunscreen to their trunks and lower limbs regularly, even though they had not been instructed to do so, Dr. Green and her associates noted.

"Our findings provide reassurance in view of the widespread uncertainty to date about sunscreen's ability to prevent melanoma," they reported.

"Although the results are directly relevant to people who live in sunny climates like Australia’s and who receive relatively high levels of ambient sun exposure as a matter of course, they also have implications for white people living in temperate climates in North America and Europe who are at increased risk of melanoma because of increased solar UV exposure caused by the predilection for holidays in sunny places," they concluded.

Regular use of sunscreen during a clinical trial of basal cell and squamous cell carcinomas was found to reduce the incidence of a different skin malignancy – new primary melanomas – up to 10 years later, according to a study published online Dec. 6 in the Journal of Clinical Oncology.

The number of invasive melanomas in particular decreased by 73%, but this was an exploratory finding "and should be interpreted cautiously," said Dr. Adéle C. Green and her associates at the Queensland Institute of Medical Research, Royal Brisbane (Australia) Hospital.

© mark wragg/iStockphoto.com

The original clinical trial, conducted in 1992-1996 and involving 1,621 white Queensland residents aged 25-75 years at baseline, examined the effects of 5 years of sunscreen application and beta-carotene supplementation on the incidence of basal and squamous cell carcinoma.

Dr. Green and her colleagues new report focuses on the incidence of melanoma as a secondary end point in the same study population. "Despite the known etiologic role of sun exposure, the question regarding sunscreen use to prevent melanoma remains open and controversial," they noted.

During the trial, 812 patients were given a free, unlimited supply of SPF-16 sunscreen and instructed to use it daily on their head, neck, arms, and hands. A comparison group of 809 patients was randomly assigned to continue using sunscreen of any SPF at their own discretion, which included no use at all in 38% and infrequent use in another 35%.

The two groups were similar in established risk factors for skin cancer, degree of sun exposure, and use of sun protection measures other than sunscreen.

Between baseline in 1992 and the end of the extended follow-up in 2006, 36 study patients developed first primary melanomas. These were in-situ malignancies in 22 subjects and invasive in 14; none of the melanomas was metastatic. Three patients who had melanoma diagnosed in 1992 were excluded.

Only 11 subjects in the sunscreen group developed melanoma, compared with 22 in the comparison group. "Risk of melanoma overall was reduced in those randomly assigned to daily sunscreen compared with discretionary use, although the result was of borderline statistical significance," the investigators reported (J. Clin. Oncol. 2010 [doi:10.1200/JCO.2010.28.7078]).

The average melanoma thickness was 0.53 mm in the sunscreen group, compared with 1.2 mm in the comparison group. The incidence of invasive melanoma was decreased by 73% with sunscreen, while the incidence of in situ lesions was not significantly different between the two groups.

Melanoma incidence was decreased at all sites on the body, not just on the sites assigned to protection by sunscreen. This is probably because many study patients in the sunscreen group applied sunscreen to their trunks and lower limbs regularly, even though they had not been instructed to do so, Dr. Green and her associates noted.

"Our findings provide reassurance in view of the widespread uncertainty to date about sunscreen's ability to prevent melanoma," they reported.

"Although the results are directly relevant to people who live in sunny climates like Australia’s and who receive relatively high levels of ambient sun exposure as a matter of course, they also have implications for white people living in temperate climates in North America and Europe who are at increased risk of melanoma because of increased solar UV exposure caused by the predilection for holidays in sunny places," they concluded.

Regular use of sunscreen during a clinical trial of basal cell and squamous cell carcinomas was found to reduce the incidence of a different skin malignancy – new primary melanomas – up to 10 years later, according to a study published online Dec. 6 in the Journal of Clinical Oncology.

The number of invasive melanomas in particular decreased by 73%, but this was an exploratory finding "and should be interpreted cautiously," said Dr. Adéle C. Green and her associates at the Queensland Institute of Medical Research, Royal Brisbane (Australia) Hospital.

© mark wragg/iStockphoto.com

The original clinical trial, conducted in 1992-1996 and involving 1,621 white Queensland residents aged 25-75 years at baseline, examined the effects of 5 years of sunscreen application and beta-carotene supplementation on the incidence of basal and squamous cell carcinoma.

Dr. Green and her colleagues new report focuses on the incidence of melanoma as a secondary end point in the same study population. "Despite the known etiologic role of sun exposure, the question regarding sunscreen use to prevent melanoma remains open and controversial," they noted.

During the trial, 812 patients were given a free, unlimited supply of SPF-16 sunscreen and instructed to use it daily on their head, neck, arms, and hands. A comparison group of 809 patients was randomly assigned to continue using sunscreen of any SPF at their own discretion, which included no use at all in 38% and infrequent use in another 35%.

The two groups were similar in established risk factors for skin cancer, degree of sun exposure, and use of sun protection measures other than sunscreen.

Between baseline in 1992 and the end of the extended follow-up in 2006, 36 study patients developed first primary melanomas. These were in-situ malignancies in 22 subjects and invasive in 14; none of the melanomas was metastatic. Three patients who had melanoma diagnosed in 1992 were excluded.

Only 11 subjects in the sunscreen group developed melanoma, compared with 22 in the comparison group. "Risk of melanoma overall was reduced in those randomly assigned to daily sunscreen compared with discretionary use, although the result was of borderline statistical significance," the investigators reported (J. Clin. Oncol. 2010 [doi:10.1200/JCO.2010.28.7078]).

The average melanoma thickness was 0.53 mm in the sunscreen group, compared with 1.2 mm in the comparison group. The incidence of invasive melanoma was decreased by 73% with sunscreen, while the incidence of in situ lesions was not significantly different between the two groups.

Melanoma incidence was decreased at all sites on the body, not just on the sites assigned to protection by sunscreen. This is probably because many study patients in the sunscreen group applied sunscreen to their trunks and lower limbs regularly, even though they had not been instructed to do so, Dr. Green and her associates noted.

"Our findings provide reassurance in view of the widespread uncertainty to date about sunscreen's ability to prevent melanoma," they reported.

"Although the results are directly relevant to people who live in sunny climates like Australia’s and who receive relatively high levels of ambient sun exposure as a matter of course, they also have implications for white people living in temperate climates in North America and Europe who are at increased risk of melanoma because of increased solar UV exposure caused by the predilection for holidays in sunny places," they concluded.

Adding a taxane to anthracycline-based adjuvant chemotherapy improves disease-free survival in women with high-risk but node-negative, early-stage breast cancer, according to a Dec. 2 report in the New England Journal of Medicine.

Such a regimen reduced the risk of recurrence by 32% during a median follow-up of 77 months in the Spanish Breast Cancer Research Group (GEICAM 9805) phase III clinical trial, compared with a regimen that did not contain a taxane, said Dr. Miguel Martín of Gregorio Marañon University General Hospital, Madrid, and his associates.

The findings indicate that adjuvant taxane therapy may be as beneficial at an early stage of disease as it is known to be at later stages of disease. Moreover, the disease-free survival benefit was consistent across many subgroups of patients, regardless of the tumor’s hormone-receptor status, the woman’s menopausal status, or the number of high-risk factors, they noted.

A longer follow-up period will be needed to determine whether this benefit translates into improved overall survival, because the number of deaths to date has been too small to make that calculation.

Dr. Martín and his colleagues undertook this study because until now, the role of taxane therapy in node-negative, early breast cancer has been "undefined." Taxanes are effective against node-positive disease, but there has been "little guidance about taxane use" in this patient group, even though the majority of patients with operable disease at diagnosis have node-negative, early-stage disease.

They performed the open-label study, which was sponsored by Sanofi-Aventis, in 1,060 patients who were treated at 55 medical centers in Spain, Germany, and Poland in 1999-2003. All study subjects had undergone primary surgery for unilateral operable breast carcinoma of stage T1, T2, or T3, and all had negative axillary lymph nodes. All the women had at least one high-risk factor, such as tumor size greater than 2 cm, negative estrogen-receptor or progesterone-receptor status, tumor histologic grade of 2 or 3, or patient age of 35 years or older.

The patients were randomly assigned to receive six 21-day cycles of adjuvant therapy with either a taxane-plus-anthracycline regimen (docetaxel, doxorubicin, and cyclophosphamide) or a nontaxane regimen (fluorouracil, doxorubicin, and cyclophosphamide). There were 539 patients in the taxane (TAC) group and 521 in the fluorouracil (FAC) group. To date, patients have been followed for up to 10 years, with a median follow-up of 6.4 years.

The primary end point (disease-free survival) was achieved by 87.8% of the TAC group, compared with 81.8% of the FAC group. "This corresponds to a 32% reduction in the risk of having an event" such as a relapse, a new primary cancer, or death (hazard ratio, 0.68), the investigators said (N. Engl. J. Med. 2010;363:2200-10).

The estimated 5-year disease-free survival rate was 90.1% with TAC and 85.3% with FAC. The number of patients who would need to be treated with a taxane regimen to prevent one recurrence was 17.

Treatment benefit was seen across all subgroups of patients, regardless of whether or not patients received radiation therapy and regardless of the type of surgery they had.

The rate of grade 3 or 4 adverse events was significantly higher in the taxane group (28.2%) than in the nontaxane group (17%), as was the rate of serious adverse events (22.4% vs 4.2%, respectively). Similarly, the rate of treatment discontinuation was significantly higher in the TAC group (4.7%) than in the FAC group (0.8%).

During the study, the researchers noted that more than 25% of patients taking the taxane regimen were developing neutropenic fever. Primary prophylaxis using granulocyte colony-stimulating factor (G-CSF) was instituted; the TAC group was already receiving prophylactic antibiotic therapy. This strategy of dual prophylaxis ameliorated most TAC-induced toxic effects, Dr. Martin and his associates noted.

This study was funded by GEICAM and Sanofi-Aventis. Data collection, data maintenance, and statistical analyses were performed by Sanofi-Aventis. No other financial conflicts of interest were reported.

Adding a taxane to anthracycline-based adjuvant chemotherapy improves disease-free survival in women with high-risk but node-negative, early-stage breast cancer, according to a Dec. 2 report in the New England Journal of Medicine.

Such a regimen reduced the risk of recurrence by 32% during a median follow-up of 77 months in the Spanish Breast Cancer Research Group (GEICAM 9805) phase III clinical trial, compared with a regimen that did not contain a taxane, said Dr. Miguel Martín of Gregorio Marañon University General Hospital, Madrid, and his associates.

The findings indicate that adjuvant taxane therapy may be as beneficial at an early stage of disease as it is known to be at later stages of disease. Moreover, the disease-free survival benefit was consistent across many subgroups of patients, regardless of the tumor’s hormone-receptor status, the woman’s menopausal status, or the number of high-risk factors, they noted.

A longer follow-up period will be needed to determine whether this benefit translates into improved overall survival, because the number of deaths to date has been too small to make that calculation.

Dr. Martín and his colleagues undertook this study because until now, the role of taxane therapy in node-negative, early breast cancer has been "undefined." Taxanes are effective against node-positive disease, but there has been "little guidance about taxane use" in this patient group, even though the majority of patients with operable disease at diagnosis have node-negative, early-stage disease.

They performed the open-label study, which was sponsored by Sanofi-Aventis, in 1,060 patients who were treated at 55 medical centers in Spain, Germany, and Poland in 1999-2003. All study subjects had undergone primary surgery for unilateral operable breast carcinoma of stage T1, T2, or T3, and all had negative axillary lymph nodes. All the women had at least one high-risk factor, such as tumor size greater than 2 cm, negative estrogen-receptor or progesterone-receptor status, tumor histologic grade of 2 or 3, or patient age of 35 years or older.

The patients were randomly assigned to receive six 21-day cycles of adjuvant therapy with either a taxane-plus-anthracycline regimen (docetaxel, doxorubicin, and cyclophosphamide) or a nontaxane regimen (fluorouracil, doxorubicin, and cyclophosphamide). There were 539 patients in the taxane (TAC) group and 521 in the fluorouracil (FAC) group. To date, patients have been followed for up to 10 years, with a median follow-up of 6.4 years.

The primary end point (disease-free survival) was achieved by 87.8% of the TAC group, compared with 81.8% of the FAC group. "This corresponds to a 32% reduction in the risk of having an event" such as a relapse, a new primary cancer, or death (hazard ratio, 0.68), the investigators said (N. Engl. J. Med. 2010;363:2200-10).

The estimated 5-year disease-free survival rate was 90.1% with TAC and 85.3% with FAC. The number of patients who would need to be treated with a taxane regimen to prevent one recurrence was 17.

Treatment benefit was seen across all subgroups of patients, regardless of whether or not patients received radiation therapy and regardless of the type of surgery they had.

The rate of grade 3 or 4 adverse events was significantly higher in the taxane group (28.2%) than in the nontaxane group (17%), as was the rate of serious adverse events (22.4% vs 4.2%, respectively). Similarly, the rate of treatment discontinuation was significantly higher in the TAC group (4.7%) than in the FAC group (0.8%).

During the study, the researchers noted that more than 25% of patients taking the taxane regimen were developing neutropenic fever. Primary prophylaxis using granulocyte colony-stimulating factor (G-CSF) was instituted; the TAC group was already receiving prophylactic antibiotic therapy. This strategy of dual prophylaxis ameliorated most TAC-induced toxic effects, Dr. Martin and his associates noted.

This study was funded by GEICAM and Sanofi-Aventis. Data collection, data maintenance, and statistical analyses were performed by Sanofi-Aventis. No other financial conflicts of interest were reported.

Adding a taxane to anthracycline-based adjuvant chemotherapy improves disease-free survival in women with high-risk but node-negative, early-stage breast cancer, according to a Dec. 2 report in the New England Journal of Medicine.

Such a regimen reduced the risk of recurrence by 32% during a median follow-up of 77 months in the Spanish Breast Cancer Research Group (GEICAM 9805) phase III clinical trial, compared with a regimen that did not contain a taxane, said Dr. Miguel Martín of Gregorio Marañon University General Hospital, Madrid, and his associates.

The findings indicate that adjuvant taxane therapy may be as beneficial at an early stage of disease as it is known to be at later stages of disease. Moreover, the disease-free survival benefit was consistent across many subgroups of patients, regardless of the tumor’s hormone-receptor status, the woman’s menopausal status, or the number of high-risk factors, they noted.

A longer follow-up period will be needed to determine whether this benefit translates into improved overall survival, because the number of deaths to date has been too small to make that calculation.

Dr. Martín and his colleagues undertook this study because until now, the role of taxane therapy in node-negative, early breast cancer has been "undefined." Taxanes are effective against node-positive disease, but there has been "little guidance about taxane use" in this patient group, even though the majority of patients with operable disease at diagnosis have node-negative, early-stage disease.

They performed the open-label study, which was sponsored by Sanofi-Aventis, in 1,060 patients who were treated at 55 medical centers in Spain, Germany, and Poland in 1999-2003. All study subjects had undergone primary surgery for unilateral operable breast carcinoma of stage T1, T2, or T3, and all had negative axillary lymph nodes. All the women had at least one high-risk factor, such as tumor size greater than 2 cm, negative estrogen-receptor or progesterone-receptor status, tumor histologic grade of 2 or 3, or patient age of 35 years or older.

The patients were randomly assigned to receive six 21-day cycles of adjuvant therapy with either a taxane-plus-anthracycline regimen (docetaxel, doxorubicin, and cyclophosphamide) or a nontaxane regimen (fluorouracil, doxorubicin, and cyclophosphamide). There were 539 patients in the taxane (TAC) group and 521 in the fluorouracil (FAC) group. To date, patients have been followed for up to 10 years, with a median follow-up of 6.4 years.

The primary end point (disease-free survival) was achieved by 87.8% of the TAC group, compared with 81.8% of the FAC group. "This corresponds to a 32% reduction in the risk of having an event" such as a relapse, a new primary cancer, or death (hazard ratio, 0.68), the investigators said (N. Engl. J. Med. 2010;363:2200-10).

The estimated 5-year disease-free survival rate was 90.1% with TAC and 85.3% with FAC. The number of patients who would need to be treated with a taxane regimen to prevent one recurrence was 17.

Treatment benefit was seen across all subgroups of patients, regardless of whether or not patients received radiation therapy and regardless of the type of surgery they had.

The rate of grade 3 or 4 adverse events was significantly higher in the taxane group (28.2%) than in the nontaxane group (17%), as was the rate of serious adverse events (22.4% vs 4.2%, respectively). Similarly, the rate of treatment discontinuation was significantly higher in the TAC group (4.7%) than in the FAC group (0.8%).

During the study, the researchers noted that more than 25% of patients taking the taxane regimen were developing neutropenic fever. Primary prophylaxis using granulocyte colony-stimulating factor (G-CSF) was instituted; the TAC group was already receiving prophylactic antibiotic therapy. This strategy of dual prophylaxis ameliorated most TAC-induced toxic effects, Dr. Martin and his associates noted.

This study was funded by GEICAM and Sanofi-Aventis. Data collection, data maintenance, and statistical analyses were performed by Sanofi-Aventis. No other financial conflicts of interest were reported.

Among white adults, both overweight and obesity are associated with increased all-cause mortality, according to a report published in the Dec. 2 issue of the New England Journal of Medicine.

Mortality is lowest within a body mass index range of 20.0-24.9, said Amy Berrington de Gonzalez, D.Phil., of the division of cancer epidemiology and genetics at the National Institutes of Health, and her associates.

© Vasilis Varsakelis/Fotolia.com

Underweight adults also appear to have a higher rate of all-cause mortality, although that association is not as strong, they said.

Some earlier studies suggested that being overweight (BMI, 25.0-29.9) either was beneficial or had little effect on all-cause mortality, while others found slightly increased risks. These inconsistencies may have been due to confounding by tobacco use or disease-related changes in weight.

"We examined the relationship between BMI and all-cause mortality in a pooled analysis of 19 prospective studies" with at least 5 years of follow-up in which smoking status and prevalent disease could be accounted for, the investigators said. The analysis was restricted to non-Hispanic white adults (mean age, 58 years at baseline) "because the relationship between BMI and mortality may differ across racial and ethnic groups," Dr. de Gonzalez and her colleagues noted.

The 19 cohorts included 1.46 million people and 160,087 deaths during a median follow-up of 10 years. A total of 58% of the study subjects were women.

When the analysis excluded smokers and people with prevalent disease, all-cause mortality was lowest at a BMI of 20.0-24.9 among both men and women and rose in a nearly linear fashion as BMI increased.

For example, in women who were overweight (BMI, 25.0-29.9), the estimated hazard ratio was 1.13; this rose to 1.44 for obesity class I (BMI, 30.0-34.9); 1.88 for obesity class II (BMI, 35.0-39.9); and 2.51 for obesity class III (BMI, 40.0-49.9). Hazard ratios were similar for men, except that they were even higher for obesity classes II and III.

"In our study, there were more than five times as many deaths among participants in the highest obesity categories (BMI of 35.0-39.9 and 40.0-49.9) than in previous studies because severe obesity has become more common," the investigators wrote. In the United States, the rates of these levels of BMI were estimated to be 11% among men and 17% among women in 2008, they added.

Statistical adjustments for other potential confounders such as alcohol consumption, physical activity level, education level, and marital status only attenuated these estimates slightly (N. Engl. J Med. 2010;363:2211-9).

Hazard ratios also increased for a BMI below 20.0, but the results varied widely according to length of follow-up and level of physical activity. In underweight people, increased mortality "is probably, at least in part, an artifact of preexisting disease," Dr. de Gonzalez and her associates said.

"The principal limitation of our study is its reliance on height, weight, and preexisting conditions at a single point in time. ... Changes in these factors may contribute to the change in hazard ratios over time," they noted.

This study was supported by the National Institutes of Health. One of Dr. de Gonzalez’s associates said he received consulting fees from Iovate Health Sciences.

Among white adults, both overweight and obesity are associated with increased all-cause mortality, according to a report published in the Dec. 2 issue of the New England Journal of Medicine.

Mortality is lowest within a body mass index range of 20.0-24.9, said Amy Berrington de Gonzalez, D.Phil., of the division of cancer epidemiology and genetics at the National Institutes of Health, and her associates.

© Vasilis Varsakelis/Fotolia.com

Underweight adults also appear to have a higher rate of all-cause mortality, although that association is not as strong, they said.

Some earlier studies suggested that being overweight (BMI, 25.0-29.9) either was beneficial or had little effect on all-cause mortality, while others found slightly increased risks. These inconsistencies may have been due to confounding by tobacco use or disease-related changes in weight.

"We examined the relationship between BMI and all-cause mortality in a pooled analysis of 19 prospective studies" with at least 5 years of follow-up in which smoking status and prevalent disease could be accounted for, the investigators said. The analysis was restricted to non-Hispanic white adults (mean age, 58 years at baseline) "because the relationship between BMI and mortality may differ across racial and ethnic groups," Dr. de Gonzalez and her colleagues noted.

The 19 cohorts included 1.46 million people and 160,087 deaths during a median follow-up of 10 years. A total of 58% of the study subjects were women.

When the analysis excluded smokers and people with prevalent disease, all-cause mortality was lowest at a BMI of 20.0-24.9 among both men and women and rose in a nearly linear fashion as BMI increased.

For example, in women who were overweight (BMI, 25.0-29.9), the estimated hazard ratio was 1.13; this rose to 1.44 for obesity class I (BMI, 30.0-34.9); 1.88 for obesity class II (BMI, 35.0-39.9); and 2.51 for obesity class III (BMI, 40.0-49.9). Hazard ratios were similar for men, except that they were even higher for obesity classes II and III.

"In our study, there were more than five times as many deaths among participants in the highest obesity categories (BMI of 35.0-39.9 and 40.0-49.9) than in previous studies because severe obesity has become more common," the investigators wrote. In the United States, the rates of these levels of BMI were estimated to be 11% among men and 17% among women in 2008, they added.

Statistical adjustments for other potential confounders such as alcohol consumption, physical activity level, education level, and marital status only attenuated these estimates slightly (N. Engl. J Med. 2010;363:2211-9).

Hazard ratios also increased for a BMI below 20.0, but the results varied widely according to length of follow-up and level of physical activity. In underweight people, increased mortality "is probably, at least in part, an artifact of preexisting disease," Dr. de Gonzalez and her associates said.

"The principal limitation of our study is its reliance on height, weight, and preexisting conditions at a single point in time. ... Changes in these factors may contribute to the change in hazard ratios over time," they noted.

This study was supported by the National Institutes of Health. One of Dr. de Gonzalez’s associates said he received consulting fees from Iovate Health Sciences.

Among white adults, both overweight and obesity are associated with increased all-cause mortality, according to a report published in the Dec. 2 issue of the New England Journal of Medicine.

Mortality is lowest within a body mass index range of 20.0-24.9, said Amy Berrington de Gonzalez, D.Phil., of the division of cancer epidemiology and genetics at the National Institutes of Health, and her associates.

© Vasilis Varsakelis/Fotolia.com

Underweight adults also appear to have a higher rate of all-cause mortality, although that association is not as strong, they said.

Some earlier studies suggested that being overweight (BMI, 25.0-29.9) either was beneficial or had little effect on all-cause mortality, while others found slightly increased risks. These inconsistencies may have been due to confounding by tobacco use or disease-related changes in weight.

"We examined the relationship between BMI and all-cause mortality in a pooled analysis of 19 prospective studies" with at least 5 years of follow-up in which smoking status and prevalent disease could be accounted for, the investigators said. The analysis was restricted to non-Hispanic white adults (mean age, 58 years at baseline) "because the relationship between BMI and mortality may differ across racial and ethnic groups," Dr. de Gonzalez and her colleagues noted.

The 19 cohorts included 1.46 million people and 160,087 deaths during a median follow-up of 10 years. A total of 58% of the study subjects were women.

When the analysis excluded smokers and people with prevalent disease, all-cause mortality was lowest at a BMI of 20.0-24.9 among both men and women and rose in a nearly linear fashion as BMI increased.

For example, in women who were overweight (BMI, 25.0-29.9), the estimated hazard ratio was 1.13; this rose to 1.44 for obesity class I (BMI, 30.0-34.9); 1.88 for obesity class II (BMI, 35.0-39.9); and 2.51 for obesity class III (BMI, 40.0-49.9). Hazard ratios were similar for men, except that they were even higher for obesity classes II and III.

"In our study, there were more than five times as many deaths among participants in the highest obesity categories (BMI of 35.0-39.9 and 40.0-49.9) than in previous studies because severe obesity has become more common," the investigators wrote. In the United States, the rates of these levels of BMI were estimated to be 11% among men and 17% among women in 2008, they added.

Statistical adjustments for other potential confounders such as alcohol consumption, physical activity level, education level, and marital status only attenuated these estimates slightly (N. Engl. J Med. 2010;363:2211-9).

Hazard ratios also increased for a BMI below 20.0, but the results varied widely according to length of follow-up and level of physical activity. In underweight people, increased mortality "is probably, at least in part, an artifact of preexisting disease," Dr. de Gonzalez and her associates said.

"The principal limitation of our study is its reliance on height, weight, and preexisting conditions at a single point in time. ... Changes in these factors may contribute to the change in hazard ratios over time," they noted.

This study was supported by the National Institutes of Health. One of Dr. de Gonzalez’s associates said he received consulting fees from Iovate Health Sciences.

Among white adults, both overweight and obesity are associated with increased all-cause mortality, according to a report published in the Dec. 2 issue of the New England Journal of Medicine.

Mortality is lowest within a body mass index range of 20.0-24.9, said Amy Berrington de Gonzalez, D.Phil., of the division of cancer epidemiology and genetics at the National Institutes of Health, and her associates.

© Vasilis Varsakelis/Fotolia.com

Underweight adults also appear to have a higher rate of all-cause mortality, although that association is not as strong, they said.

Some earlier studies suggested that being overweight (BMI, 25.0-29.9) either was beneficial or had little effect on all-cause mortality, while others found slightly increased risks. These inconsistencies may have been due to confounding by tobacco use or disease-related changes in weight.

"We examined the relationship between BMI and all-cause mortality in a pooled analysis of 19 prospective studies" with at least 5 years of follow-up in which smoking status and prevalent disease could be accounted for, the investigators said. The analysis was restricted to non-Hispanic white adults (mean age, 58 years at baseline) "because the relationship between BMI and mortality may differ across racial and ethnic groups," Dr. de Gonzalez and her colleagues noted.

The 19 cohorts included 1.46 million people and 160,087 deaths during a median follow-up of 10 years. A total of 58% of the study subjects were women.

When the analysis excluded smokers and people with prevalent disease, all-cause mortality was lowest at a BMI of 20.0-24.9 among both men and women and rose in a nearly linear fashion as BMI increased.

For example, in women who were overweight (BMI, 25.0-29.9), the estimated hazard ratio was 1.13; this rose to 1.44 for obesity class I (BMI, 30.0-34.9); 1.88 for obesity class II (BMI, 35.0-39.9); and 2.51 for obesity class III (BMI, 40.0-49.9). Hazard ratios were similar for men, except that they were even higher for obesity classes II and III.

"In our study, there were more than five times as many deaths among participants in the highest obesity categories (BMI of 35.0-39.9 and 40.0-49.9) than in previous studies because severe obesity has become more common," the investigators wrote. In the United States, the rates of these levels of BMI were estimated to be 11% among men and 17% among women in 2008, they added.

Statistical adjustments for other potential confounders such as alcohol consumption, physical activity level, education level, and marital status only attenuated these estimates slightly (N. Engl. J Med. 2010;363:2211-9).

Hazard ratios also increased for a BMI below 20.0, but the results varied widely according to length of follow-up and level of physical activity. In underweight people, increased mortality "is probably, at least in part, an artifact of preexisting disease," Dr. de Gonzalez and her associates said.

"The principal limitation of our study is its reliance on height, weight, and preexisting conditions at a single point in time. ... Changes in these factors may contribute to the change in hazard ratios over time," they noted.

This study was supported by the National Institutes of Health. One of Dr. de Gonzalez’s associates said he received consulting fees from Iovate Health Sciences.

Among white adults, both overweight and obesity are associated with increased all-cause mortality, according to a report published in the Dec. 2 issue of the New England Journal of Medicine.

Mortality is lowest within a body mass index range of 20.0-24.9, said Amy Berrington de Gonzalez, D.Phil., of the division of cancer epidemiology and genetics at the National Institutes of Health, and her associates.

© Vasilis Varsakelis/Fotolia.com

Underweight adults also appear to have a higher rate of all-cause mortality, although that association is not as strong, they said.

Some earlier studies suggested that being overweight (BMI, 25.0-29.9) either was beneficial or had little effect on all-cause mortality, while others found slightly increased risks. These inconsistencies may have been due to confounding by tobacco use or disease-related changes in weight.

"We examined the relationship between BMI and all-cause mortality in a pooled analysis of 19 prospective studies" with at least 5 years of follow-up in which smoking status and prevalent disease could be accounted for, the investigators said. The analysis was restricted to non-Hispanic white adults (mean age, 58 years at baseline) "because the relationship between BMI and mortality may differ across racial and ethnic groups," Dr. de Gonzalez and her colleagues noted.

The 19 cohorts included 1.46 million people and 160,087 deaths during a median follow-up of 10 years. A total of 58% of the study subjects were women.

When the analysis excluded smokers and people with prevalent disease, all-cause mortality was lowest at a BMI of 20.0-24.9 among both men and women and rose in a nearly linear fashion as BMI increased.

For example, in women who were overweight (BMI, 25.0-29.9), the estimated hazard ratio was 1.13; this rose to 1.44 for obesity class I (BMI, 30.0-34.9); 1.88 for obesity class II (BMI, 35.0-39.9); and 2.51 for obesity class III (BMI, 40.0-49.9). Hazard ratios were similar for men, except that they were even higher for obesity classes II and III.

"In our study, there were more than five times as many deaths among participants in the highest obesity categories (BMI of 35.0-39.9 and 40.0-49.9) than in previous studies because severe obesity has become more common," the investigators wrote. In the United States, the rates of these levels of BMI were estimated to be 11% among men and 17% among women in 2008, they added.

Statistical adjustments for other potential confounders such as alcohol consumption, physical activity level, education level, and marital status only attenuated these estimates slightly (N. Engl. J Med. 2010;363:2211-9).

Hazard ratios also increased for a BMI below 20.0, but the results varied widely according to length of follow-up and level of physical activity. In underweight people, increased mortality "is probably, at least in part, an artifact of preexisting disease," Dr. de Gonzalez and her associates said.

"The principal limitation of our study is its reliance on height, weight, and preexisting conditions at a single point in time. ... Changes in these factors may contribute to the change in hazard ratios over time," they noted.

This study was supported by the National Institutes of Health. One of Dr. de Gonzalez’s associates said he received consulting fees from Iovate Health Sciences.

Among white adults, both overweight and obesity are associated with increased all-cause mortality, according to a report published in the Dec. 2 issue of the New England Journal of Medicine.

Mortality is lowest within a body mass index range of 20.0-24.9, said Amy Berrington de Gonzalez, D.Phil., of the division of cancer epidemiology and genetics at the National Institutes of Health, and her associates.

© Vasilis Varsakelis/Fotolia.com

Underweight adults also appear to have a higher rate of all-cause mortality, although that association is not as strong, they said.

Some earlier studies suggested that being overweight (BMI, 25.0-29.9) either was beneficial or had little effect on all-cause mortality, while others found slightly increased risks. These inconsistencies may have been due to confounding by tobacco use or disease-related changes in weight.

"We examined the relationship between BMI and all-cause mortality in a pooled analysis of 19 prospective studies" with at least 5 years of follow-up in which smoking status and prevalent disease could be accounted for, the investigators said. The analysis was restricted to non-Hispanic white adults (mean age, 58 years at baseline) "because the relationship between BMI and mortality may differ across racial and ethnic groups," Dr. de Gonzalez and her colleagues noted.

The 19 cohorts included 1.46 million people and 160,087 deaths during a median follow-up of 10 years. A total of 58% of the study subjects were women.

When the analysis excluded smokers and people with prevalent disease, all-cause mortality was lowest at a BMI of 20.0-24.9 among both men and women and rose in a nearly linear fashion as BMI increased.

For example, in women who were overweight (BMI, 25.0-29.9), the estimated hazard ratio was 1.13; this rose to 1.44 for obesity class I (BMI, 30.0-34.9); 1.88 for obesity class II (BMI, 35.0-39.9); and 2.51 for obesity class III (BMI, 40.0-49.9). Hazard ratios were similar for men, except that they were even higher for obesity classes II and III.

"In our study, there were more than five times as many deaths among participants in the highest obesity categories (BMI of 35.0-39.9 and 40.0-49.9) than in previous studies because severe obesity has become more common," the investigators wrote. In the United States, the rates of these levels of BMI were estimated to be 11% among men and 17% among women in 2008, they added.

Statistical adjustments for other potential confounders such as alcohol consumption, physical activity level, education level, and marital status only attenuated these estimates slightly (N. Engl. J Med. 2010;363:2211-9).

Hazard ratios also increased for a BMI below 20.0, but the results varied widely according to length of follow-up and level of physical activity. In underweight people, increased mortality "is probably, at least in part, an artifact of preexisting disease," Dr. de Gonzalez and her associates said.

"The principal limitation of our study is its reliance on height, weight, and preexisting conditions at a single point in time. ... Changes in these factors may contribute to the change in hazard ratios over time," they noted.

This study was supported by the National Institutes of Health. One of Dr. de Gonzalez’s associates said he received consulting fees from Iovate Health Sciences.

Major Finding: The use of GnRH agonists as androgen deprivation therapy for prostate cancer rose dramatically from the 1990s until 2004, an interval in which Medicare reimbursement for the drugs was profitable for physicians. It then declined markedly in 2004 and 2005, when the government's reimbursement policy was changed and use of the drugs was no longer as profitable.

Data Source: A cohort study using data on 54,925 patients with prostate cancer who were enrolled in the SEER database 1994-2005.

Disclosures: This study was funded by the American Cancer Society. Dr. Shahinian reported working as a consultant to Amgen.

For men with prostate cancer, use of gonadotropin-releasing hormone agonists rose dramatically in the 1990s, when Medicare reimbursement for the drugs was highly profitable for physicians, and dropped just as dramatically after 2004, when reimbursement was drastically lowered, according to an analysis of Medicare data.

The recent reductions in use were most profound among patients for whom the drugs were probably not beneficial and therefore inappropriate. In contrast, among the types of patients for whom the GnRH agonists' benefit has been established, use did not change with reimbursement level, said Dr. Vahakn B. Shahinian of the University of Michigan, Ann Arbor, and his associates.

“Our findings suggest that reductions in reimbursement may influence the delivery of care in a potentially beneficial way, with even the modest changes in 2004 [in reimbursement policy] associated with a substantial decrease in the use of inappropriate therapy,” they noted.

The investigators used data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database on older cancer patients to test their hypothesis that, given the 50% cut over 2 years in reimbursement to physicians administering the GnRH agonists, the use of the androgen deprivation therapy “would decline markedly for indications for which there was limited evidence of efficacy” but would continue to be used for truly evidence-based indications.

The researchers categorized the use of androgen-deprivation therapy in 54,925 prostate cancer patients seen from 1994 through 2005 as inappropriate, appropriate, or discretionary – the last category being for therapy of uncertain benefit because of insufficient evidence or because reasonable alternatives were available.

“Reimbursement for GnRH agonists per monthly dose fell from $356 in 2003 to $311 in 2004 and to $176 in 2005,” Dr. Shahinian and colleagues noted.

The rate of inappropriate use of the drugs increased steadily from 30% in 1994 to a peak of 45% in 2002, then dropped precipitously, according to the analysis. “In the inappropriate-use group, there was a dramatic drop in rates … from 39% in the fourth quarter of 2003 to 30% in the first quarter of 2004, with a continued decline to 22% by the end of 2005,” the researchers said (N. Engl. J. Med. 2010;363:1822-32).

In the discretionary-use group, the rate of use also was highest in 2003, “gradually declined in 2004, and dropped more markedly in 2005,” they added. Rates of use did not decline in the appropriate-use group.

“These findings are consistent with previous research on the influence of financial incentives on the delivery of health care,” the investigators said, adding that “Financial incentives are most likely to have an effect on physicians' behavior in cases in which medical uncertainty exists, as opposed to cases in which care is clearly lifesaving.”

The authors acknowledged that a guideline change by American Society of Clinical Oncology in 2004 may have influenced physicians to reach for GnRH for localized high-risk disease.

Additionally, it is possible that increasing recognition of the adverse effects of androgen-deprivation therapy may have contributed to some of the reductions in use of the drugs.

One major study published in 2005 demonstrated a link between the treatment and fracture risk. Since the changes in reimbursement policy roughly coincided with this publication, “it is difficult to separate out the contributions of these influences,” the researchers noted.

The corollary to their findings is that reimbursement policies should be carefully crafted to avoid inadvertently providing incentives for care for which no clear benefit has been established, they added.

Major Finding: The use of GnRH agonists as androgen deprivation therapy for prostate cancer rose dramatically from the 1990s until 2004, an interval in which Medicare reimbursement for the drugs was profitable for physicians. It then declined markedly in 2004 and 2005, when the government's reimbursement policy was changed and use of the drugs was no longer as profitable.

Data Source: A cohort study using data on 54,925 patients with prostate cancer who were enrolled in the SEER database 1994-2005.

Disclosures: This study was funded by the American Cancer Society. Dr. Shahinian reported working as a consultant to Amgen.

For men with prostate cancer, use of gonadotropin-releasing hormone agonists rose dramatically in the 1990s, when Medicare reimbursement for the drugs was highly profitable for physicians, and dropped just as dramatically after 2004, when reimbursement was drastically lowered, according to an analysis of Medicare data.

The recent reductions in use were most profound among patients for whom the drugs were probably not beneficial and therefore inappropriate. In contrast, among the types of patients for whom the GnRH agonists' benefit has been established, use did not change with reimbursement level, said Dr. Vahakn B. Shahinian of the University of Michigan, Ann Arbor, and his associates.

“Our findings suggest that reductions in reimbursement may influence the delivery of care in a potentially beneficial way, with even the modest changes in 2004 [in reimbursement policy] associated with a substantial decrease in the use of inappropriate therapy,” they noted.

The investigators used data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database on older cancer patients to test their hypothesis that, given the 50% cut over 2 years in reimbursement to physicians administering the GnRH agonists, the use of the androgen deprivation therapy “would decline markedly for indications for which there was limited evidence of efficacy” but would continue to be used for truly evidence-based indications.

The researchers categorized the use of androgen-deprivation therapy in 54,925 prostate cancer patients seen from 1994 through 2005 as inappropriate, appropriate, or discretionary – the last category being for therapy of uncertain benefit because of insufficient evidence or because reasonable alternatives were available.

“Reimbursement for GnRH agonists per monthly dose fell from $356 in 2003 to $311 in 2004 and to $176 in 2005,” Dr. Shahinian and colleagues noted.

The rate of inappropriate use of the drugs increased steadily from 30% in 1994 to a peak of 45% in 2002, then dropped precipitously, according to the analysis. “In the inappropriate-use group, there was a dramatic drop in rates … from 39% in the fourth quarter of 2003 to 30% in the first quarter of 2004, with a continued decline to 22% by the end of 2005,” the researchers said (N. Engl. J. Med. 2010;363:1822-32).

In the discretionary-use group, the rate of use also was highest in 2003, “gradually declined in 2004, and dropped more markedly in 2005,” they added. Rates of use did not decline in the appropriate-use group.

“These findings are consistent with previous research on the influence of financial incentives on the delivery of health care,” the investigators said, adding that “Financial incentives are most likely to have an effect on physicians' behavior in cases in which medical uncertainty exists, as opposed to cases in which care is clearly lifesaving.”

The authors acknowledged that a guideline change by American Society of Clinical Oncology in 2004 may have influenced physicians to reach for GnRH for localized high-risk disease.

Additionally, it is possible that increasing recognition of the adverse effects of androgen-deprivation therapy may have contributed to some of the reductions in use of the drugs.

One major study published in 2005 demonstrated a link between the treatment and fracture risk. Since the changes in reimbursement policy roughly coincided with this publication, “it is difficult to separate out the contributions of these influences,” the researchers noted.

The corollary to their findings is that reimbursement policies should be carefully crafted to avoid inadvertently providing incentives for care for which no clear benefit has been established, they added.

Major Finding: The use of GnRH agonists as androgen deprivation therapy for prostate cancer rose dramatically from the 1990s until 2004, an interval in which Medicare reimbursement for the drugs was profitable for physicians. It then declined markedly in 2004 and 2005, when the government's reimbursement policy was changed and use of the drugs was no longer as profitable.

Data Source: A cohort study using data on 54,925 patients with prostate cancer who were enrolled in the SEER database 1994-2005.

Disclosures: This study was funded by the American Cancer Society. Dr. Shahinian reported working as a consultant to Amgen.

For men with prostate cancer, use of gonadotropin-releasing hormone agonists rose dramatically in the 1990s, when Medicare reimbursement for the drugs was highly profitable for physicians, and dropped just as dramatically after 2004, when reimbursement was drastically lowered, according to an analysis of Medicare data.

The recent reductions in use were most profound among patients for whom the drugs were probably not beneficial and therefore inappropriate. In contrast, among the types of patients for whom the GnRH agonists' benefit has been established, use did not change with reimbursement level, said Dr. Vahakn B. Shahinian of the University of Michigan, Ann Arbor, and his associates.

“Our findings suggest that reductions in reimbursement may influence the delivery of care in a potentially beneficial way, with even the modest changes in 2004 [in reimbursement policy] associated with a substantial decrease in the use of inappropriate therapy,” they noted.

The investigators used data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database on older cancer patients to test their hypothesis that, given the 50% cut over 2 years in reimbursement to physicians administering the GnRH agonists, the use of the androgen deprivation therapy “would decline markedly for indications for which there was limited evidence of efficacy” but would continue to be used for truly evidence-based indications.

The researchers categorized the use of androgen-deprivation therapy in 54,925 prostate cancer patients seen from 1994 through 2005 as inappropriate, appropriate, or discretionary – the last category being for therapy of uncertain benefit because of insufficient evidence or because reasonable alternatives were available.

“Reimbursement for GnRH agonists per monthly dose fell from $356 in 2003 to $311 in 2004 and to $176 in 2005,” Dr. Shahinian and colleagues noted.

The rate of inappropriate use of the drugs increased steadily from 30% in 1994 to a peak of 45% in 2002, then dropped precipitously, according to the analysis. “In the inappropriate-use group, there was a dramatic drop in rates … from 39% in the fourth quarter of 2003 to 30% in the first quarter of 2004, with a continued decline to 22% by the end of 2005,” the researchers said (N. Engl. J. Med. 2010;363:1822-32).

In the discretionary-use group, the rate of use also was highest in 2003, “gradually declined in 2004, and dropped more markedly in 2005,” they added. Rates of use did not decline in the appropriate-use group.

“These findings are consistent with previous research on the influence of financial incentives on the delivery of health care,” the investigators said, adding that “Financial incentives are most likely to have an effect on physicians' behavior in cases in which medical uncertainty exists, as opposed to cases in which care is clearly lifesaving.”

The authors acknowledged that a guideline change by American Society of Clinical Oncology in 2004 may have influenced physicians to reach for GnRH for localized high-risk disease.

Additionally, it is possible that increasing recognition of the adverse effects of androgen-deprivation therapy may have contributed to some of the reductions in use of the drugs.

One major study published in 2005 demonstrated a link between the treatment and fracture risk. Since the changes in reimbursement policy roughly coincided with this publication, “it is difficult to separate out the contributions of these influences,” the researchers noted.

The corollary to their findings is that reimbursement policies should be carefully crafted to avoid inadvertently providing incentives for care for which no clear benefit has been established, they added.

Combined aerobic and resistance exercise training lowered hemoglobin A_1c levels modestly in patients with type 2 diabetes, while either type of training alone did not, according to a recent report.

Patients who participated in the combined exercise also were able to decrease their hypoglycemic medication more often than were those who participated in either type of exercise alone, said Dr. Timothy S. Church of Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and his associates.

The investigators assessed outcomes in 262 sedentary adults (mean age 56 years) with type 2 diabetes during a 9-month exercise intervention in which no attempt was made to alter patients' diets, medication usage, or other lifestyle factors. The study subjects were randomly assigned to undergo aerobic training only (72 patients), resistance training only (73 patients), a combination of both (76 patients), or no exercise training (41 patients serving as a control group).

The interventions were specifically designed so that all study subjects would spend the same amount of time exercising – approximately 140 minutes per week. This ensured that any differences between the combined-exercise group and the other exercise groups could be attributed to the activity itself, rather than to an extended time spent exercising in the combination group.

All the interventions took place in a laboratory facility and were closely supervised. In addition, study subjects had monthly visits with a certified diabetes educator who reviewed fasting glucose records and measured weight and HbA_1c levels from finger-prick blood samples.

The study population was ethnically diverse (44% African American) and included a high proportion of women (63%). The mean duration of diabetes was 7 years and the mean BMI was 34.9; 97% of the subjects were taking diabetes medications, including 18% on insulin.

Compared with the control group, the combination exercise group showed an absolute decrease in HbA_1c levels of 0.34%. Patients who performed resistance training only showed a 0.16% decrease and those who performed aerobic training only showed a 0.24% decrease, neither of which was statistically significant.

“An absolute decrease of 1% in HbA_1c levels has been associated with a 15%-20% decrease in major cardiovascular disease events and 37% decrease in microvascular complications. Thus, our observed reduction [of 0.3%-0.4%] might be expected to produce a 5%-7% reduction in cardiovascular disease risk and a 12% reduction in microvascular complications,” Dr. Church and his associates said (JAMA 2010;304:2253-62).

In a subgroup analysis confined only to subjects whose baseline HbA_1c levels were 7% or higher, both the combination exercise group and the aerobic exercise group showed significant reductions in HbA_1c, compared with the control group. In this subgroup of patients, such reductions could be expected to reduce cardiovascular disease events by 7%-10% and microvascular complications by 18%, they added.

All three intervention groups showed modest decreases in weight circumference, which were similar across the groups. Patients who did both aerobic and resistance training showed the largest decreases in diabetes medications.

“To our knowledge, this is the first large randomized trial involving individuals with type 2 diabetes to directly test exercise prescriptions that are consistent with the 2008 Physical Activity Guidelines of 500-1000 MET (metabolic equivalent tasks)-minutes per week combined with resistance training,” the investigators noted.

This study was supported by the National Institutes of Health. Dr. Church and his associates reported numerous ties to scientific, educational, and lay groups, as well as to makers of pharmaceuticals and medical devices.

Combined aerobic and resistance exercise training lowered hemoglobin A_1c levels modestly in patients with type 2 diabetes, while either type of training alone did not, according to a recent report.

Patients who participated in the combined exercise also were able to decrease their hypoglycemic medication more often than were those who participated in either type of exercise alone, said Dr. Timothy S. Church of Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and his associates.

The investigators assessed outcomes in 262 sedentary adults (mean age 56 years) with type 2 diabetes during a 9-month exercise intervention in which no attempt was made to alter patients' diets, medication usage, or other lifestyle factors. The study subjects were randomly assigned to undergo aerobic training only (72 patients), resistance training only (73 patients), a combination of both (76 patients), or no exercise training (41 patients serving as a control group).

The interventions were specifically designed so that all study subjects would spend the same amount of time exercising – approximately 140 minutes per week. This ensured that any differences between the combined-exercise group and the other exercise groups could be attributed to the activity itself, rather than to an extended time spent exercising in the combination group.

All the interventions took place in a laboratory facility and were closely supervised. In addition, study subjects had monthly visits with a certified diabetes educator who reviewed fasting glucose records and measured weight and HbA_1c levels from finger-prick blood samples.

The study population was ethnically diverse (44% African American) and included a high proportion of women (63%). The mean duration of diabetes was 7 years and the mean BMI was 34.9; 97% of the subjects were taking diabetes medications, including 18% on insulin.

Compared with the control group, the combination exercise group showed an absolute decrease in HbA_1c levels of 0.34%. Patients who performed resistance training only showed a 0.16% decrease and those who performed aerobic training only showed a 0.24% decrease, neither of which was statistically significant.

“An absolute decrease of 1% in HbA_1c levels has been associated with a 15%-20% decrease in major cardiovascular disease events and 37% decrease in microvascular complications. Thus, our observed reduction [of 0.3%-0.4%] might be expected to produce a 5%-7% reduction in cardiovascular disease risk and a 12% reduction in microvascular complications,” Dr. Church and his associates said (JAMA 2010;304:2253-62).

In a subgroup analysis confined only to subjects whose baseline HbA_1c levels were 7% or higher, both the combination exercise group and the aerobic exercise group showed significant reductions in HbA_1c, compared with the control group. In this subgroup of patients, such reductions could be expected to reduce cardiovascular disease events by 7%-10% and microvascular complications by 18%, they added.

All three intervention groups showed modest decreases in weight circumference, which were similar across the groups. Patients who did both aerobic and resistance training showed the largest decreases in diabetes medications.

“To our knowledge, this is the first large randomized trial involving individuals with type 2 diabetes to directly test exercise prescriptions that are consistent with the 2008 Physical Activity Guidelines of 500-1000 MET (metabolic equivalent tasks)-minutes per week combined with resistance training,” the investigators noted.

This study was supported by the National Institutes of Health. Dr. Church and his associates reported numerous ties to scientific, educational, and lay groups, as well as to makers of pharmaceuticals and medical devices.

Combined aerobic and resistance exercise training lowered hemoglobin A_1c levels modestly in patients with type 2 diabetes, while either type of training alone did not, according to a recent report.

Patients who participated in the combined exercise also were able to decrease their hypoglycemic medication more often than were those who participated in either type of exercise alone, said Dr. Timothy S. Church of Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and his associates.

The investigators assessed outcomes in 262 sedentary adults (mean age 56 years) with type 2 diabetes during a 9-month exercise intervention in which no attempt was made to alter patients' diets, medication usage, or other lifestyle factors. The study subjects were randomly assigned to undergo aerobic training only (72 patients), resistance training only (73 patients), a combination of both (76 patients), or no exercise training (41 patients serving as a control group).

The interventions were specifically designed so that all study subjects would spend the same amount of time exercising – approximately 140 minutes per week. This ensured that any differences between the combined-exercise group and the other exercise groups could be attributed to the activity itself, rather than to an extended time spent exercising in the combination group.

All the interventions took place in a laboratory facility and were closely supervised. In addition, study subjects had monthly visits with a certified diabetes educator who reviewed fasting glucose records and measured weight and HbA_1c levels from finger-prick blood samples.

The study population was ethnically diverse (44% African American) and included a high proportion of women (63%). The mean duration of diabetes was 7 years and the mean BMI was 34.9; 97% of the subjects were taking diabetes medications, including 18% on insulin.

Compared with the control group, the combination exercise group showed an absolute decrease in HbA_1c levels of 0.34%. Patients who performed resistance training only showed a 0.16% decrease and those who performed aerobic training only showed a 0.24% decrease, neither of which was statistically significant.

“An absolute decrease of 1% in HbA_1c levels has been associated with a 15%-20% decrease in major cardiovascular disease events and 37% decrease in microvascular complications. Thus, our observed reduction [of 0.3%-0.4%] might be expected to produce a 5%-7% reduction in cardiovascular disease risk and a 12% reduction in microvascular complications,” Dr. Church and his associates said (JAMA 2010;304:2253-62).

In a subgroup analysis confined only to subjects whose baseline HbA_1c levels were 7% or higher, both the combination exercise group and the aerobic exercise group showed significant reductions in HbA_1c, compared with the control group. In this subgroup of patients, such reductions could be expected to reduce cardiovascular disease events by 7%-10% and microvascular complications by 18%, they added.

All three intervention groups showed modest decreases in weight circumference, which were similar across the groups. Patients who did both aerobic and resistance training showed the largest decreases in diabetes medications.

“To our knowledge, this is the first large randomized trial involving individuals with type 2 diabetes to directly test exercise prescriptions that are consistent with the 2008 Physical Activity Guidelines of 500-1000 MET (metabolic equivalent tasks)-minutes per week combined with resistance training,” the investigators noted.

This study was supported by the National Institutes of Health. Dr. Church and his associates reported numerous ties to scientific, educational, and lay groups, as well as to makers of pharmaceuticals and medical devices.

Major Finding: Among patients who must take antiplatelet drugs, PPIs are appropriate only for those who have a history of, or multiple risk factors for, GI bleeding.

Data Source: A comprehensive review of the literature by a committee of cardiologists, gastroenterologists, and other experts.

Disclosures: The work of the expert consensus document writing committee was supported exclusively by the ACCF with no industry support.

Proton pump inhibitors are appropriate in patients who have multiple risk factors for gastrointestinal bleeding and who require antiplatelet therapy, according to an updated expert consensus report published online simultaneously by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

The last consensus report, released in 2008, recommended the use of PPIs to prevent GI bleeding events in patients taking antiplatelet agents, but subsequent clinical experience and research raised concerns about an adverse interaction between the two classes of drugs. Since then, “it has been difficult for practitioners to assimilate this flood of information and to develop optimal treatment strategies for managing patients who might benefit from antiplatelet therapy, yet who might suffer from GI bleeding,” said Dr. Neena S. Abraham, chair of the report's writing committee, and her associates.

“Our goal was to carefully evaluate recent studies that suggested a potential dangerous interaction between PPIs and thienopyridines, in order to provide clinicians with a pragmatic, evidence-based approach for safer prescribing of antiplatelet drugs, especially among patients in whom the risk-benefit ratio requires a careful assessment,” Dr. Abraham, a gastroenterologist at the Michael E. DeBakey VA Medical Center and associate professor of medicine at Baylor College of Medicine, both in Houston, said in a press statement accompanying the consensus document.

The 2010 report “summarizes the best evidence and incorporates the expert clinical viewpoints of both cardiologists and gastroenterologists, who face this dilemma on a daily basis,” Dr. Abraham noted.

Among the new consensus statement's findings are the following:

▸ PPIs are recommended to reduce GI bleeding in patients with a history of such bleeding, as well as in those with multiple risk factors for GI bleeding, such as a history of peptic ulcer disease; advanced age; use of anticoagulants, steroids, or NSAIDs; and Helicobacter pylori infection.

▸ Routine use of PPIs is not recommended for patients who are at lower risk of GI bleeding and have much less potential to benefit from prophylactic therapy.

▸ Clinical decisions regarding combined therapy must balance overall risks and benefits, considering both cardiovascular and gastrointestinal complications.

▸ Research suggests that concomitant use of clopidogrel in particular and a PPI reduces clopidogrel's antiplatelet effects. However, it has not been established whether the changes in surrogate end points, such as platelet assays, used in these studies translate into clinically meaningful differences.

▸ Observational studies and one randomized clinical trial have shown inconsistent effects on cardiovascular outcomes when thienopyridines and PPIs are combined. It is possible that a clinically important interaction does occur, particularly in certain subgroups such as patients who metabolize clopidogrel poorly.

▸ Pharmacogenomic testing (for example, to identify patients with impaired metabolism of antiplatelet drugs) and platelet function testing might prove to be helpful in managing combined therapy, but that has not yet been established.

▸ Drug interactions might be minimized by separating the dosing of the two agents, but as of now there is no solid evidence to recommend such dosing alterations.

Overall, PPIs should be prescribed in tandem with antiplatelet drugs for only one indication: to reduce the increased risk of GI complications caused by antiplatelet drugs, the report concludes (J. Am. Coll. Cardiol. 2010 Nov. 8 [doi:10.1016/j.jacc.2010.09.010]).

Dr. Mark A. Hlatky, vice chair of the consensus statement's writing committee and a cardiologist at Stanford (Calif.) University, said in the press statement that the combined use of PPIs and antiplatelet drugs “must be individualized, not done as a matter of routine.

“The risk of GI bleeding varies among individuals, as does the risk of cardiac events,” he noted.

Major Finding: Among patients who must take antiplatelet drugs, PPIs are appropriate only for those who have a history of, or multiple risk factors for, GI bleeding.

Data Source: A comprehensive review of the literature by a committee of cardiologists, gastroenterologists, and other experts.

Disclosures: The work of the expert consensus document writing committee was supported exclusively by the ACCF with no industry support.

Proton pump inhibitors are appropriate in patients who have multiple risk factors for gastrointestinal bleeding and who require antiplatelet therapy, according to an updated expert consensus report published online simultaneously by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

The last consensus report, released in 2008, recommended the use of PPIs to prevent GI bleeding events in patients taking antiplatelet agents, but subsequent clinical experience and research raised concerns about an adverse interaction between the two classes of drugs. Since then, “it has been difficult for practitioners to assimilate this flood of information and to develop optimal treatment strategies for managing patients who might benefit from antiplatelet therapy, yet who might suffer from GI bleeding,” said Dr. Neena S. Abraham, chair of the report's writing committee, and her associates.

“Our goal was to carefully evaluate recent studies that suggested a potential dangerous interaction between PPIs and thienopyridines, in order to provide clinicians with a pragmatic, evidence-based approach for safer prescribing of antiplatelet drugs, especially among patients in whom the risk-benefit ratio requires a careful assessment,” Dr. Abraham, a gastroenterologist at the Michael E. DeBakey VA Medical Center and associate professor of medicine at Baylor College of Medicine, both in Houston, said in a press statement accompanying the consensus document.

The 2010 report “summarizes the best evidence and incorporates the expert clinical viewpoints of both cardiologists and gastroenterologists, who face this dilemma on a daily basis,” Dr. Abraham noted.

Among the new consensus statement's findings are the following:

▸ PPIs are recommended to reduce GI bleeding in patients with a history of such bleeding, as well as in those with multiple risk factors for GI bleeding, such as a history of peptic ulcer disease; advanced age; use of anticoagulants, steroids, or NSAIDs; and Helicobacter pylori infection.

▸ Routine use of PPIs is not recommended for patients who are at lower risk of GI bleeding and have much less potential to benefit from prophylactic therapy.

▸ Clinical decisions regarding combined therapy must balance overall risks and benefits, considering both cardiovascular and gastrointestinal complications.

▸ Research suggests that concomitant use of clopidogrel in particular and a PPI reduces clopidogrel's antiplatelet effects. However, it has not been established whether the changes in surrogate end points, such as platelet assays, used in these studies translate into clinically meaningful differences.

▸ Observational studies and one randomized clinical trial have shown inconsistent effects on cardiovascular outcomes when thienopyridines and PPIs are combined. It is possible that a clinically important interaction does occur, particularly in certain subgroups such as patients who metabolize clopidogrel poorly.

▸ Pharmacogenomic testing (for example, to identify patients with impaired metabolism of antiplatelet drugs) and platelet function testing might prove to be helpful in managing combined therapy, but that has not yet been established.

▸ Drug interactions might be minimized by separating the dosing of the two agents, but as of now there is no solid evidence to recommend such dosing alterations.

Overall, PPIs should be prescribed in tandem with antiplatelet drugs for only one indication: to reduce the increased risk of GI complications caused by antiplatelet drugs, the report concludes (J. Am. Coll. Cardiol. 2010 Nov. 8 [doi:10.1016/j.jacc.2010.09.010]).

Dr. Mark A. Hlatky, vice chair of the consensus statement's writing committee and a cardiologist at Stanford (Calif.) University, said in the press statement that the combined use of PPIs and antiplatelet drugs “must be individualized, not done as a matter of routine.

“The risk of GI bleeding varies among individuals, as does the risk of cardiac events,” he noted.

Major Finding: Among patients who must take antiplatelet drugs, PPIs are appropriate only for those who have a history of, or multiple risk factors for, GI bleeding.

Data Source: A comprehensive review of the literature by a committee of cardiologists, gastroenterologists, and other experts.

Disclosures: The work of the expert consensus document writing committee was supported exclusively by the ACCF with no industry support.

Proton pump inhibitors are appropriate in patients who have multiple risk factors for gastrointestinal bleeding and who require antiplatelet therapy, according to an updated expert consensus report published online simultaneously by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

The last consensus report, released in 2008, recommended the use of PPIs to prevent GI bleeding events in patients taking antiplatelet agents, but subsequent clinical experience and research raised concerns about an adverse interaction between the two classes of drugs. Since then, “it has been difficult for practitioners to assimilate this flood of information and to develop optimal treatment strategies for managing patients who might benefit from antiplatelet therapy, yet who might suffer from GI bleeding,” said Dr. Neena S. Abraham, chair of the report's writing committee, and her associates.

“Our goal was to carefully evaluate recent studies that suggested a potential dangerous interaction between PPIs and thienopyridines, in order to provide clinicians with a pragmatic, evidence-based approach for safer prescribing of antiplatelet drugs, especially among patients in whom the risk-benefit ratio requires a careful assessment,” Dr. Abraham, a gastroenterologist at the Michael E. DeBakey VA Medical Center and associate professor of medicine at Baylor College of Medicine, both in Houston, said in a press statement accompanying the consensus document.

The 2010 report “summarizes the best evidence and incorporates the expert clinical viewpoints of both cardiologists and gastroenterologists, who face this dilemma on a daily basis,” Dr. Abraham noted.

Among the new consensus statement's findings are the following:

▸ PPIs are recommended to reduce GI bleeding in patients with a history of such bleeding, as well as in those with multiple risk factors for GI bleeding, such as a history of peptic ulcer disease; advanced age; use of anticoagulants, steroids, or NSAIDs; and Helicobacter pylori infection.

▸ Routine use of PPIs is not recommended for patients who are at lower risk of GI bleeding and have much less potential to benefit from prophylactic therapy.

▸ Clinical decisions regarding combined therapy must balance overall risks and benefits, considering both cardiovascular and gastrointestinal complications.

▸ Research suggests that concomitant use of clopidogrel in particular and a PPI reduces clopidogrel's antiplatelet effects. However, it has not been established whether the changes in surrogate end points, such as platelet assays, used in these studies translate into clinically meaningful differences.

▸ Observational studies and one randomized clinical trial have shown inconsistent effects on cardiovascular outcomes when thienopyridines and PPIs are combined. It is possible that a clinically important interaction does occur, particularly in certain subgroups such as patients who metabolize clopidogrel poorly.

▸ Pharmacogenomic testing (for example, to identify patients with impaired metabolism of antiplatelet drugs) and platelet function testing might prove to be helpful in managing combined therapy, but that has not yet been established.

▸ Drug interactions might be minimized by separating the dosing of the two agents, but as of now there is no solid evidence to recommend such dosing alterations.

Overall, PPIs should be prescribed in tandem with antiplatelet drugs for only one indication: to reduce the increased risk of GI complications caused by antiplatelet drugs, the report concludes (J. Am. Coll. Cardiol. 2010 Nov. 8 [doi:10.1016/j.jacc.2010.09.010]).

Dr. Mark A. Hlatky, vice chair of the consensus statement's writing committee and a cardiologist at Stanford (Calif.) University, said in the press statement that the combined use of PPIs and antiplatelet drugs “must be individualized, not done as a matter of routine.

“The risk of GI bleeding varies among individuals, as does the risk of cardiac events,” he noted.