Mary Ann Moon

Adding the monoclonal antibody pertuzumab to standard neoadjuvant therapy with trastuzumab plus docetaxel increased the rate of complete tumor response in the proof-of-concept NeoSphere study of women with locally advanced, inflammatory, or early HER2-positive breast cancer, as published online Dec. 6 in Lancet Oncology.

The addition of pertuzumab, which has a different binding site and a complementary mechanism of action to trastuzumab (Herceptin), did not appear to increase the number or severity of treatment-related adverse events in the industry-sponsored, open-label, phase II study, said Dr. Luca Gianni of San Raffaele Cancer Centre in Milan (Italy), and his associates.

"The tumor response to this new triplet combination is one of the highest reported to date, despite just a short treatment time, and could be a big advance for women with HER2-positive disease," Dr. Gianni noted in a press statement accompanying the report.

In the international study, 417 treatment-naive patients at 59 medical centers were randomly assigned to receive 12 weeks of conventional therapy with neoadjuvant trastuzumab plus docetaxel (Taxotere), or pertuzumab and trastuzumab plus docetaxel, or pertuzumab and trastuzumab with no chemotherapy, or pertuzumab plus docetaxel before undergoing surgery. In all, 25 patients, "mostly in the chemotherapy-free group," did not complete surgery as planned. Following surgery, patients in all groups received adjuvant conventional treatment including anthracyclines and trastuzumab for 1 year.

The primary efficacy end point was complete pathologic response within the breast, defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor at surgery. This was achieved in 46% of women given the triplet, compared with only 29% of those given conventional therapy, 17% of those given both monoclonal antibodies but no chemotherapy, and 24% of those given pertuzumab plus chemotherapy.

Thus, the triplet was more effective than was conventional treatment, as well as being more effective than chemotherapy plus either monoclonal antibody alone, Dr. Gianni and his colleagues said (Lancet Oncol. 2011 Dec. 6 [doi:10.1016/S1470-2045(11)70336-9]).

The triplet was particularly effective in the subgroup of women with hormone receptor–negative tumors, with a complete response rate of 63%, they noted. In addition, dual HER2 blockade by pertuzumab and trastuzumab completely eradicated breast tumors in 27% of patients who did not receive docetaxel for these tumors.

The 17% complete response rate among all patients given both monoclonal antibodies without chemotherapy was notable. It suggests that a proportion of HER2-positive tumors can be eradicated without any chemotherapy, "which might have immediate use for women who cannot receive cytotoxic drugs," the investigators added.

Approximately one-third of this subgroup of patients did not respond to the dual-antibody regimen, and that may be attributable to the short duration of neoadjuvant treatment. This possibility will be assessed in clinical trials with longer-term therapy, the researchers said.

As expected with docetaxel, the most common adverse events of grade 3 or higher were neutropenia, febrile neutropenia, and leukopenia. The rates of adverse events (12%-14%) and serious adverse events (10%-17%) were similar across the three groups that received docetaxel, and were markedly lower in the group that didn’t receive it (2% and 4%, respectively).

In particular, cardiac toxicity was considered "good," but a longer observation period will be necessary to rule out the possibility that adding pertuzumab may increase cardiotoxicity. The mean maximal decrease in left ventricular ejection fraction (LVEF) was 4%-5% and was similar across all treatment groups. "No significant change was detected when pertuzumab was added to trastuzumab, and no patient had an LVEF decrease to less than 40% at any time during the study. Four patients [three receiving conventional therapy and one receiving triple-combination therapy] showed LVEF declines of 10%-15% from baseline and to less than 50% during the neoadjuvant period," Dr. Gianni and his associates said.

In July, Roche announced that it plans to see Food and Drug Administration approval based on a survival advantage for the triplet in the phase III CLEOPATRA trial. Data from that study will be presented this week at the San Antonio Breast Cancer Symposium.

This NeoSphere study was funded by Hoffmann-La Roche, maker of pertuzumab; the company provided the study drugs and was involved in the study design, safety monitoring and reporting, and data management and anaylsis. Fondazione Michelangelo also provided support. Dr. Gianni is an advisory board member for Roche, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Wyeth, and Novartis. Three coauthors are Roche employees; two disclosed Roche stock ownership.

Adding the monoclonal antibody pertuzumab to standard neoadjuvant therapy with trastuzumab plus docetaxel increased the rate of complete tumor response in the proof-of-concept NeoSphere study of women with locally advanced, inflammatory, or early HER2-positive breast cancer, as published online Dec. 6 in Lancet Oncology.

The addition of pertuzumab, which has a different binding site and a complementary mechanism of action to trastuzumab (Herceptin), did not appear to increase the number or severity of treatment-related adverse events in the industry-sponsored, open-label, phase II study, said Dr. Luca Gianni of San Raffaele Cancer Centre in Milan (Italy), and his associates.

"The tumor response to this new triplet combination is one of the highest reported to date, despite just a short treatment time, and could be a big advance for women with HER2-positive disease," Dr. Gianni noted in a press statement accompanying the report.

In the international study, 417 treatment-naive patients at 59 medical centers were randomly assigned to receive 12 weeks of conventional therapy with neoadjuvant trastuzumab plus docetaxel (Taxotere), or pertuzumab and trastuzumab plus docetaxel, or pertuzumab and trastuzumab with no chemotherapy, or pertuzumab plus docetaxel before undergoing surgery. In all, 25 patients, "mostly in the chemotherapy-free group," did not complete surgery as planned. Following surgery, patients in all groups received adjuvant conventional treatment including anthracyclines and trastuzumab for 1 year.

The primary efficacy end point was complete pathologic response within the breast, defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor at surgery. This was achieved in 46% of women given the triplet, compared with only 29% of those given conventional therapy, 17% of those given both monoclonal antibodies but no chemotherapy, and 24% of those given pertuzumab plus chemotherapy.

Thus, the triplet was more effective than was conventional treatment, as well as being more effective than chemotherapy plus either monoclonal antibody alone, Dr. Gianni and his colleagues said (Lancet Oncol. 2011 Dec. 6 [doi:10.1016/S1470-2045(11)70336-9]).

The triplet was particularly effective in the subgroup of women with hormone receptor–negative tumors, with a complete response rate of 63%, they noted. In addition, dual HER2 blockade by pertuzumab and trastuzumab completely eradicated breast tumors in 27% of patients who did not receive docetaxel for these tumors.

The 17% complete response rate among all patients given both monoclonal antibodies without chemotherapy was notable. It suggests that a proportion of HER2-positive tumors can be eradicated without any chemotherapy, "which might have immediate use for women who cannot receive cytotoxic drugs," the investigators added.

Approximately one-third of this subgroup of patients did not respond to the dual-antibody regimen, and that may be attributable to the short duration of neoadjuvant treatment. This possibility will be assessed in clinical trials with longer-term therapy, the researchers said.

As expected with docetaxel, the most common adverse events of grade 3 or higher were neutropenia, febrile neutropenia, and leukopenia. The rates of adverse events (12%-14%) and serious adverse events (10%-17%) were similar across the three groups that received docetaxel, and were markedly lower in the group that didn’t receive it (2% and 4%, respectively).

In particular, cardiac toxicity was considered "good," but a longer observation period will be necessary to rule out the possibility that adding pertuzumab may increase cardiotoxicity. The mean maximal decrease in left ventricular ejection fraction (LVEF) was 4%-5% and was similar across all treatment groups. "No significant change was detected when pertuzumab was added to trastuzumab, and no patient had an LVEF decrease to less than 40% at any time during the study. Four patients [three receiving conventional therapy and one receiving triple-combination therapy] showed LVEF declines of 10%-15% from baseline and to less than 50% during the neoadjuvant period," Dr. Gianni and his associates said.

In July, Roche announced that it plans to see Food and Drug Administration approval based on a survival advantage for the triplet in the phase III CLEOPATRA trial. Data from that study will be presented this week at the San Antonio Breast Cancer Symposium.

This NeoSphere study was funded by Hoffmann-La Roche, maker of pertuzumab; the company provided the study drugs and was involved in the study design, safety monitoring and reporting, and data management and anaylsis. Fondazione Michelangelo also provided support. Dr. Gianni is an advisory board member for Roche, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Wyeth, and Novartis. Three coauthors are Roche employees; two disclosed Roche stock ownership.

Adding the monoclonal antibody pertuzumab to standard neoadjuvant therapy with trastuzumab plus docetaxel increased the rate of complete tumor response in the proof-of-concept NeoSphere study of women with locally advanced, inflammatory, or early HER2-positive breast cancer, as published online Dec. 6 in Lancet Oncology.

The addition of pertuzumab, which has a different binding site and a complementary mechanism of action to trastuzumab (Herceptin), did not appear to increase the number or severity of treatment-related adverse events in the industry-sponsored, open-label, phase II study, said Dr. Luca Gianni of San Raffaele Cancer Centre in Milan (Italy), and his associates.

"The tumor response to this new triplet combination is one of the highest reported to date, despite just a short treatment time, and could be a big advance for women with HER2-positive disease," Dr. Gianni noted in a press statement accompanying the report.

In the international study, 417 treatment-naive patients at 59 medical centers were randomly assigned to receive 12 weeks of conventional therapy with neoadjuvant trastuzumab plus docetaxel (Taxotere), or pertuzumab and trastuzumab plus docetaxel, or pertuzumab and trastuzumab with no chemotherapy, or pertuzumab plus docetaxel before undergoing surgery. In all, 25 patients, "mostly in the chemotherapy-free group," did not complete surgery as planned. Following surgery, patients in all groups received adjuvant conventional treatment including anthracyclines and trastuzumab for 1 year.

The primary efficacy end point was complete pathologic response within the breast, defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor at surgery. This was achieved in 46% of women given the triplet, compared with only 29% of those given conventional therapy, 17% of those given both monoclonal antibodies but no chemotherapy, and 24% of those given pertuzumab plus chemotherapy.

Thus, the triplet was more effective than was conventional treatment, as well as being more effective than chemotherapy plus either monoclonal antibody alone, Dr. Gianni and his colleagues said (Lancet Oncol. 2011 Dec. 6 [doi:10.1016/S1470-2045(11)70336-9]).

The triplet was particularly effective in the subgroup of women with hormone receptor–negative tumors, with a complete response rate of 63%, they noted. In addition, dual HER2 blockade by pertuzumab and trastuzumab completely eradicated breast tumors in 27% of patients who did not receive docetaxel for these tumors.

The 17% complete response rate among all patients given both monoclonal antibodies without chemotherapy was notable. It suggests that a proportion of HER2-positive tumors can be eradicated without any chemotherapy, "which might have immediate use for women who cannot receive cytotoxic drugs," the investigators added.

Approximately one-third of this subgroup of patients did not respond to the dual-antibody regimen, and that may be attributable to the short duration of neoadjuvant treatment. This possibility will be assessed in clinical trials with longer-term therapy, the researchers said.

As expected with docetaxel, the most common adverse events of grade 3 or higher were neutropenia, febrile neutropenia, and leukopenia. The rates of adverse events (12%-14%) and serious adverse events (10%-17%) were similar across the three groups that received docetaxel, and were markedly lower in the group that didn’t receive it (2% and 4%, respectively).

In particular, cardiac toxicity was considered "good," but a longer observation period will be necessary to rule out the possibility that adding pertuzumab may increase cardiotoxicity. The mean maximal decrease in left ventricular ejection fraction (LVEF) was 4%-5% and was similar across all treatment groups. "No significant change was detected when pertuzumab was added to trastuzumab, and no patient had an LVEF decrease to less than 40% at any time during the study. Four patients [three receiving conventional therapy and one receiving triple-combination therapy] showed LVEF declines of 10%-15% from baseline and to less than 50% during the neoadjuvant period," Dr. Gianni and his associates said.

In July, Roche announced that it plans to see Food and Drug Administration approval based on a survival advantage for the triplet in the phase III CLEOPATRA trial. Data from that study will be presented this week at the San Antonio Breast Cancer Symposium.

This NeoSphere study was funded by Hoffmann-La Roche, maker of pertuzumab; the company provided the study drugs and was involved in the study design, safety monitoring and reporting, and data management and anaylsis. Fondazione Michelangelo also provided support. Dr. Gianni is an advisory board member for Roche, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Wyeth, and Novartis. Three coauthors are Roche employees; two disclosed Roche stock ownership.

Unless rules specify that schoolchildren get more of both physical education and recess, schools are likely to trim time from one to boost the other, therefore leaving kids’ total level of physical activity ultimately unchanged and inadequate, researchers say.

According to a study published online Dec. 5 in Archives of Pediatrics and Adolescent Medicine, both state laws and school district policies mandating or recommending increased physical activity during the school day are effective at increasing PE class time and recess time among elementary students.

©Linda Kloosterhof/iStockphoto.com

But schools tend to "compensate for any increased physical activity in one area by decreasing other physical activity opportunities," an important finding for policy makers to understand, wrote Sandy J. Slater, Ph.D., of the Institute for Health Research and Policy at the University of Illinois at Chicago School of Public Health, and her associates.

Dr. Slater and her colleagues examined this issue in what they described as the first study to assess nationally the impact of state- and district-level policies on public grade-school PE and recess time practices.

They cited previous research indicating that fewer than 20% of third-grade students at public schools in the United States are offered both 150 min/week of PE as well as one or more 20-minute session of recess per day that are recommended by the National Association for Sport and Physical Education.

Dr. Slater’s team collected data on physical activity in schools by surveying principals at a nationally representative sample of 1,761 schools about daily schedules for third-graders, as well as by asking them to identify barriers to compliance with the recommendations regarding physical activity. The researchers separately assessed state and school district laws and policies regarding physical activity.

Only 18% of the respondents offered 150 min/week of PE, and only 70% of schools offered at least 20 minutes of daily recess.

Most states (83%) had no laws regarding recess, and fewer than half had "some kind of law" concerning PE.

Schools were significantly more likely to offer the recommended PE and recess times if they were located in states that had such laws (odds ratio, 2.8). But even in the absence of state laws, schools located in districts that had policies encouraging regularly scheduled PE and recess times were significantly more likely to meet the recommendations (OR, 2.4).

However, schools everywhere tended to "borrow from Peter to pay Paul" if their laws and recommendations addressed only PE or only recess, rather than both activities. Schools in which PE was emphasized made time for PE classes by subtracting from recess time, and those in which recess was emphasized made time for recess by subtracting from PE class time, rather than providing the recommended time for both. Schools meeting the recess recommendations were less likely to meet the PE criterion (OR, 0.5); those meeting the PE recommendation were 50% less likely to meet the recess criterion, the investigators found.

Thus, to increase physical activity in schools, "policy makers may need to mandate more of both PE and recess time," the investigators said (Arch. Pediatr. Adoles. Med. 2011 Dec. 5 [doi:10.1001/archpediatrics.2011.1133]).

In accordance with this finding, most principals reported that "competing time demands" were the largest barrier to complying with recommendations. And having a longer than usual school day closely correlated with meeting the NASPE standards for both PE and recess.

Schools with predominantly white students were more likely than those with other racial groups to offer daily recess. In addition, schools with the highest number of students receiving free or reduced-cost lunches – a proxy for having greater numbers of students from low-income homes – were the least likely to provide daily recess and provided the fewest weekly minutes of PE.

"Latino and African American children have higher rates of being overweight or obese than their white counterparts, and the prevalence of obesity is significantly higher among low- vs. high-income groups," Dr. Slater and her associates wrote.

"Therefore, it is important to develop strategies to increase the number of minutes of recess offered specifically for these vulnerable populations most at risk to acquire the many health complications associated with obesity."

The investigators noted that their self-reported study’s "cross-sectional design limits causal interpretation" and that they had no information on children’s actual activity during recess and PE. Furthermore, the study was limited to public schools, which are not governed by all state laws.

This study was supported by the Robert Wood Johnson Foundation and the Eunice Kennedy Shriver National Institute on Child Health and Human Development. No financial conflicts of interest were reported by the investigators.

Unless rules specify that schoolchildren get more of both physical education and recess, schools are likely to trim time from one to boost the other, therefore leaving kids’ total level of physical activity ultimately unchanged and inadequate, researchers say.

According to a study published online Dec. 5 in Archives of Pediatrics and Adolescent Medicine, both state laws and school district policies mandating or recommending increased physical activity during the school day are effective at increasing PE class time and recess time among elementary students.

©Linda Kloosterhof/iStockphoto.com

But schools tend to "compensate for any increased physical activity in one area by decreasing other physical activity opportunities," an important finding for policy makers to understand, wrote Sandy J. Slater, Ph.D., of the Institute for Health Research and Policy at the University of Illinois at Chicago School of Public Health, and her associates.

Dr. Slater and her colleagues examined this issue in what they described as the first study to assess nationally the impact of state- and district-level policies on public grade-school PE and recess time practices.

They cited previous research indicating that fewer than 20% of third-grade students at public schools in the United States are offered both 150 min/week of PE as well as one or more 20-minute session of recess per day that are recommended by the National Association for Sport and Physical Education.

Dr. Slater’s team collected data on physical activity in schools by surveying principals at a nationally representative sample of 1,761 schools about daily schedules for third-graders, as well as by asking them to identify barriers to compliance with the recommendations regarding physical activity. The researchers separately assessed state and school district laws and policies regarding physical activity.

Only 18% of the respondents offered 150 min/week of PE, and only 70% of schools offered at least 20 minutes of daily recess.

Most states (83%) had no laws regarding recess, and fewer than half had "some kind of law" concerning PE.

Schools were significantly more likely to offer the recommended PE and recess times if they were located in states that had such laws (odds ratio, 2.8). But even in the absence of state laws, schools located in districts that had policies encouraging regularly scheduled PE and recess times were significantly more likely to meet the recommendations (OR, 2.4).

However, schools everywhere tended to "borrow from Peter to pay Paul" if their laws and recommendations addressed only PE or only recess, rather than both activities. Schools in which PE was emphasized made time for PE classes by subtracting from recess time, and those in which recess was emphasized made time for recess by subtracting from PE class time, rather than providing the recommended time for both. Schools meeting the recess recommendations were less likely to meet the PE criterion (OR, 0.5); those meeting the PE recommendation were 50% less likely to meet the recess criterion, the investigators found.

Thus, to increase physical activity in schools, "policy makers may need to mandate more of both PE and recess time," the investigators said (Arch. Pediatr. Adoles. Med. 2011 Dec. 5 [doi:10.1001/archpediatrics.2011.1133]).

In accordance with this finding, most principals reported that "competing time demands" were the largest barrier to complying with recommendations. And having a longer than usual school day closely correlated with meeting the NASPE standards for both PE and recess.

Schools with predominantly white students were more likely than those with other racial groups to offer daily recess. In addition, schools with the highest number of students receiving free or reduced-cost lunches – a proxy for having greater numbers of students from low-income homes – were the least likely to provide daily recess and provided the fewest weekly minutes of PE.

"Latino and African American children have higher rates of being overweight or obese than their white counterparts, and the prevalence of obesity is significantly higher among low- vs. high-income groups," Dr. Slater and her associates wrote.

"Therefore, it is important to develop strategies to increase the number of minutes of recess offered specifically for these vulnerable populations most at risk to acquire the many health complications associated with obesity."

The investigators noted that their self-reported study’s "cross-sectional design limits causal interpretation" and that they had no information on children’s actual activity during recess and PE. Furthermore, the study was limited to public schools, which are not governed by all state laws.

This study was supported by the Robert Wood Johnson Foundation and the Eunice Kennedy Shriver National Institute on Child Health and Human Development. No financial conflicts of interest were reported by the investigators.

Unless rules specify that schoolchildren get more of both physical education and recess, schools are likely to trim time from one to boost the other, therefore leaving kids’ total level of physical activity ultimately unchanged and inadequate, researchers say.

According to a study published online Dec. 5 in Archives of Pediatrics and Adolescent Medicine, both state laws and school district policies mandating or recommending increased physical activity during the school day are effective at increasing PE class time and recess time among elementary students.

©Linda Kloosterhof/iStockphoto.com

But schools tend to "compensate for any increased physical activity in one area by decreasing other physical activity opportunities," an important finding for policy makers to understand, wrote Sandy J. Slater, Ph.D., of the Institute for Health Research and Policy at the University of Illinois at Chicago School of Public Health, and her associates.

Dr. Slater and her colleagues examined this issue in what they described as the first study to assess nationally the impact of state- and district-level policies on public grade-school PE and recess time practices.

They cited previous research indicating that fewer than 20% of third-grade students at public schools in the United States are offered both 150 min/week of PE as well as one or more 20-minute session of recess per day that are recommended by the National Association for Sport and Physical Education.

Dr. Slater’s team collected data on physical activity in schools by surveying principals at a nationally representative sample of 1,761 schools about daily schedules for third-graders, as well as by asking them to identify barriers to compliance with the recommendations regarding physical activity. The researchers separately assessed state and school district laws and policies regarding physical activity.

Only 18% of the respondents offered 150 min/week of PE, and only 70% of schools offered at least 20 minutes of daily recess.

Most states (83%) had no laws regarding recess, and fewer than half had "some kind of law" concerning PE.

Schools were significantly more likely to offer the recommended PE and recess times if they were located in states that had such laws (odds ratio, 2.8). But even in the absence of state laws, schools located in districts that had policies encouraging regularly scheduled PE and recess times were significantly more likely to meet the recommendations (OR, 2.4).

However, schools everywhere tended to "borrow from Peter to pay Paul" if their laws and recommendations addressed only PE or only recess, rather than both activities. Schools in which PE was emphasized made time for PE classes by subtracting from recess time, and those in which recess was emphasized made time for recess by subtracting from PE class time, rather than providing the recommended time for both. Schools meeting the recess recommendations were less likely to meet the PE criterion (OR, 0.5); those meeting the PE recommendation were 50% less likely to meet the recess criterion, the investigators found.

Thus, to increase physical activity in schools, "policy makers may need to mandate more of both PE and recess time," the investigators said (Arch. Pediatr. Adoles. Med. 2011 Dec. 5 [doi:10.1001/archpediatrics.2011.1133]).

In accordance with this finding, most principals reported that "competing time demands" were the largest barrier to complying with recommendations. And having a longer than usual school day closely correlated with meeting the NASPE standards for both PE and recess.

Schools with predominantly white students were more likely than those with other racial groups to offer daily recess. In addition, schools with the highest number of students receiving free or reduced-cost lunches – a proxy for having greater numbers of students from low-income homes – were the least likely to provide daily recess and provided the fewest weekly minutes of PE.

"Latino and African American children have higher rates of being overweight or obese than their white counterparts, and the prevalence of obesity is significantly higher among low- vs. high-income groups," Dr. Slater and her associates wrote.

"Therefore, it is important to develop strategies to increase the number of minutes of recess offered specifically for these vulnerable populations most at risk to acquire the many health complications associated with obesity."

The investigators noted that their self-reported study’s "cross-sectional design limits causal interpretation" and that they had no information on children’s actual activity during recess and PE. Furthermore, the study was limited to public schools, which are not governed by all state laws.

This study was supported by the Robert Wood Johnson Foundation and the Eunice Kennedy Shriver National Institute on Child Health and Human Development. No financial conflicts of interest were reported by the investigators.

Major Finding: The subjects who had been normal weight throughout the study and those who had been overweight or obese as children but became nonobese by young adulthood, had no increased relative risk for developing type 2 diabetes, whereas those who were overweight or obese in childhood and remained so in young adulthood had a 5.4-fold increase in relative risk for developing type 2 diabetes, and those who were obese in childhood and remained so in young adulthood had a 4.5-fold increase in relative risk for developing type 2 diabetes.

Data Source: A pooled analysis of data from four longitudinal cohort studies of CV risk factors in 6,328 subjects who were assessed at ages 3-18 years and again a mean of 23 years later during young adulthood.

Disclosures: This pooled analysis was supported by funding for the original four longitudinal cohort studies. Dr. Juonala reported no relevant financial disclosures. Dr. Juonala's associates reported ties to Pfizer, Merck, and AstraZeneca.

Overweight or obese children who lose weight by the time they reach young adulthood markedly decrease their cardiovascular risks, according to a report.

Although childhood overweight and obesity frequently persist into adulthood, some children lose weight, often during adolescence, and become nonobese adults. According to this analysis of four large cohort studies that tracked cardiovascular risk factors over two decades, such weight loss dramatically reduces their risk of type 2 diabetes, hypertension, dyslipidemia, and carotid-artery atherosclerosis in young adulthood, wrote Dr. Markus Juonala of the Research Center of Applied and Preventive Cardiovascular Medicine, University of Turku (Finland), and his associates.

“Although the observational nature of our study precludes making clinical recommendations, we hypothesize that reducing BMI [body mass index] in children and adolescents who are overweight or obese could reduce their cardiovascular risk. If this hypothesis is correct, primary care physicians should not take the pessimistic view that once childhood obesity is established, CV risk is also determined, but should recognize that CV risk may be substantially reduced if childhood obesity is successfully treated,” said Dr. Juonala and his colleagues in the International Childhood Cardiovascular Cohort Consortium.

The consortium was created specifically to analyze the data pooled from four cohorts – the Bogalusa Heart Study and the Muscatine Study in the United States, the Childhood Determinants of Adult Health study in Australia, and the Cardiovascular Risk in Young Finns study in Finland – in which subjects underwent a baseline assessment of CV risk factors at ages 3-18 years and a follow-up assessment a mean of 23 years later.

There were 6,328 subjects (2,961 males and 3,367 females). At baseline during childhood, the prevalence of overweight or obesity was 12.2%, and that of obesity was 2.3%. At follow-up during young adulthood, the prevalence of overweight or obesity was 54.9%, and that of obesity was 20.7%.

As expected, “our data confirm both the increase in CV risk associated with childhood overweight or obesity and the tracking of adiposity between childhood and adulthood,” the investigators said.

A total of 774 subjects had been overweight or obese as children, and 500 of them (64.6%) remained obese as adults. Another 147 subjects had been obese as children, and 121 (82.3%) of them remained obese as adults. In these subjects, overweight or obesity were strong predictors of type 2 diabetes, hypertension, poor cholesterol profiles, and reduced carotid-artery intima-media thickness (a proxy measure for incipient CV disease, since the cohorts were too young to have experienced CV events).

Among 5,554 subjects who had had normal weight as children, 812 (14.6%) were obese as adults. As expected, these subjects who were of normal weight in childhood but became overweight or obese as adults also had adverse CV risk profiles.

However, subjects who had been overweight or obese as children but became nonobese by young adulthood had CV risk profiles similar to those of subjects who had been of normal weight throughout their lives, Dr. Juonala and his associates wrote (N. Engl. J. Med. 2011;365:1876-85).

For example, the subjects who had been normal weight throughout the study and those who had been overweight or obese as children but became nonobese by young adulthood had no increased relative risk for developing type 2 diabetes, whereas those who were overweight or obese in childhood and remained so in young adulthood had a 5.4-fold increase in relative risk for developing type 2 diabetes.

Eighty-two percent of obese children were obese as adults, versus only 15% of normal-weight children.

Source ©annedde/iStockphoto.com

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Target the Right Population

Juonala et al. found that during an interval of almost 25 years, “only 15% of subjects who were of normal weight as children [became] obese as adults, whereas 65% of those who were overweight or obese as children and 82% of those who were obese as children were obese as adults,” said Dr. Albert P. Rocchini.

“These figures suggest that targeting interventions for obesity prevention and treatment specifically to children who are at high risk for becoming obese will prove to be a more valuable and more cost-effective strategy than targeting these interventions to whole populations of children,” he noted.

DR. ROCCHINI is in the pediatric cardiology division at C.S. Mott Children's Hospital and the University of Michigan, Ann Arbor. These remarks were taken from his editorial comment accompanying the report of Dr. Juonala et al. (N. Engl. J. Med. 2011;365:1927-9). Dr. Rocchini said he had no relevant financial disclosures.

Major Finding: The subjects who had been normal weight throughout the study and those who had been overweight or obese as children but became nonobese by young adulthood, had no increased relative risk for developing type 2 diabetes, whereas those who were overweight or obese in childhood and remained so in young adulthood had a 5.4-fold increase in relative risk for developing type 2 diabetes, and those who were obese in childhood and remained so in young adulthood had a 4.5-fold increase in relative risk for developing type 2 diabetes.

Data Source: A pooled analysis of data from four longitudinal cohort studies of CV risk factors in 6,328 subjects who were assessed at ages 3-18 years and again a mean of 23 years later during young adulthood.

Disclosures: This pooled analysis was supported by funding for the original four longitudinal cohort studies. Dr. Juonala reported no relevant financial disclosures. Dr. Juonala's associates reported ties to Pfizer, Merck, and AstraZeneca.

Overweight or obese children who lose weight by the time they reach young adulthood markedly decrease their cardiovascular risks, according to a report.

Although childhood overweight and obesity frequently persist into adulthood, some children lose weight, often during adolescence, and become nonobese adults. According to this analysis of four large cohort studies that tracked cardiovascular risk factors over two decades, such weight loss dramatically reduces their risk of type 2 diabetes, hypertension, dyslipidemia, and carotid-artery atherosclerosis in young adulthood, wrote Dr. Markus Juonala of the Research Center of Applied and Preventive Cardiovascular Medicine, University of Turku (Finland), and his associates.

“Although the observational nature of our study precludes making clinical recommendations, we hypothesize that reducing BMI [body mass index] in children and adolescents who are overweight or obese could reduce their cardiovascular risk. If this hypothesis is correct, primary care physicians should not take the pessimistic view that once childhood obesity is established, CV risk is also determined, but should recognize that CV risk may be substantially reduced if childhood obesity is successfully treated,” said Dr. Juonala and his colleagues in the International Childhood Cardiovascular Cohort Consortium.

The consortium was created specifically to analyze the data pooled from four cohorts – the Bogalusa Heart Study and the Muscatine Study in the United States, the Childhood Determinants of Adult Health study in Australia, and the Cardiovascular Risk in Young Finns study in Finland – in which subjects underwent a baseline assessment of CV risk factors at ages 3-18 years and a follow-up assessment a mean of 23 years later.

There were 6,328 subjects (2,961 males and 3,367 females). At baseline during childhood, the prevalence of overweight or obesity was 12.2%, and that of obesity was 2.3%. At follow-up during young adulthood, the prevalence of overweight or obesity was 54.9%, and that of obesity was 20.7%.

As expected, “our data confirm both the increase in CV risk associated with childhood overweight or obesity and the tracking of adiposity between childhood and adulthood,” the investigators said.

A total of 774 subjects had been overweight or obese as children, and 500 of them (64.6%) remained obese as adults. Another 147 subjects had been obese as children, and 121 (82.3%) of them remained obese as adults. In these subjects, overweight or obesity were strong predictors of type 2 diabetes, hypertension, poor cholesterol profiles, and reduced carotid-artery intima-media thickness (a proxy measure for incipient CV disease, since the cohorts were too young to have experienced CV events).

Among 5,554 subjects who had had normal weight as children, 812 (14.6%) were obese as adults. As expected, these subjects who were of normal weight in childhood but became overweight or obese as adults also had adverse CV risk profiles.

However, subjects who had been overweight or obese as children but became nonobese by young adulthood had CV risk profiles similar to those of subjects who had been of normal weight throughout their lives, Dr. Juonala and his associates wrote (N. Engl. J. Med. 2011;365:1876-85).

For example, the subjects who had been normal weight throughout the study and those who had been overweight or obese as children but became nonobese by young adulthood had no increased relative risk for developing type 2 diabetes, whereas those who were overweight or obese in childhood and remained so in young adulthood had a 5.4-fold increase in relative risk for developing type 2 diabetes.

Eighty-two percent of obese children were obese as adults, versus only 15% of normal-weight children.

Source ©annedde/iStockphoto.com

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Target the Right Population

Juonala et al. found that during an interval of almost 25 years, “only 15% of subjects who were of normal weight as children [became] obese as adults, whereas 65% of those who were overweight or obese as children and 82% of those who were obese as children were obese as adults,” said Dr. Albert P. Rocchini.

“These figures suggest that targeting interventions for obesity prevention and treatment specifically to children who are at high risk for becoming obese will prove to be a more valuable and more cost-effective strategy than targeting these interventions to whole populations of children,” he noted.

DR. ROCCHINI is in the pediatric cardiology division at C.S. Mott Children's Hospital and the University of Michigan, Ann Arbor. These remarks were taken from his editorial comment accompanying the report of Dr. Juonala et al. (N. Engl. J. Med. 2011;365:1927-9). Dr. Rocchini said he had no relevant financial disclosures.

Major Finding: The subjects who had been normal weight throughout the study and those who had been overweight or obese as children but became nonobese by young adulthood, had no increased relative risk for developing type 2 diabetes, whereas those who were overweight or obese in childhood and remained so in young adulthood had a 5.4-fold increase in relative risk for developing type 2 diabetes, and those who were obese in childhood and remained so in young adulthood had a 4.5-fold increase in relative risk for developing type 2 diabetes.

Data Source: A pooled analysis of data from four longitudinal cohort studies of CV risk factors in 6,328 subjects who were assessed at ages 3-18 years and again a mean of 23 years later during young adulthood.

Disclosures: This pooled analysis was supported by funding for the original four longitudinal cohort studies. Dr. Juonala reported no relevant financial disclosures. Dr. Juonala's associates reported ties to Pfizer, Merck, and AstraZeneca.

Overweight or obese children who lose weight by the time they reach young adulthood markedly decrease their cardiovascular risks, according to a report.

Although childhood overweight and obesity frequently persist into adulthood, some children lose weight, often during adolescence, and become nonobese adults. According to this analysis of four large cohort studies that tracked cardiovascular risk factors over two decades, such weight loss dramatically reduces their risk of type 2 diabetes, hypertension, dyslipidemia, and carotid-artery atherosclerosis in young adulthood, wrote Dr. Markus Juonala of the Research Center of Applied and Preventive Cardiovascular Medicine, University of Turku (Finland), and his associates.

“Although the observational nature of our study precludes making clinical recommendations, we hypothesize that reducing BMI [body mass index] in children and adolescents who are overweight or obese could reduce their cardiovascular risk. If this hypothesis is correct, primary care physicians should not take the pessimistic view that once childhood obesity is established, CV risk is also determined, but should recognize that CV risk may be substantially reduced if childhood obesity is successfully treated,” said Dr. Juonala and his colleagues in the International Childhood Cardiovascular Cohort Consortium.

The consortium was created specifically to analyze the data pooled from four cohorts – the Bogalusa Heart Study and the Muscatine Study in the United States, the Childhood Determinants of Adult Health study in Australia, and the Cardiovascular Risk in Young Finns study in Finland – in which subjects underwent a baseline assessment of CV risk factors at ages 3-18 years and a follow-up assessment a mean of 23 years later.

There were 6,328 subjects (2,961 males and 3,367 females). At baseline during childhood, the prevalence of overweight or obesity was 12.2%, and that of obesity was 2.3%. At follow-up during young adulthood, the prevalence of overweight or obesity was 54.9%, and that of obesity was 20.7%.

As expected, “our data confirm both the increase in CV risk associated with childhood overweight or obesity and the tracking of adiposity between childhood and adulthood,” the investigators said.

A total of 774 subjects had been overweight or obese as children, and 500 of them (64.6%) remained obese as adults. Another 147 subjects had been obese as children, and 121 (82.3%) of them remained obese as adults. In these subjects, overweight or obesity were strong predictors of type 2 diabetes, hypertension, poor cholesterol profiles, and reduced carotid-artery intima-media thickness (a proxy measure for incipient CV disease, since the cohorts were too young to have experienced CV events).

Among 5,554 subjects who had had normal weight as children, 812 (14.6%) were obese as adults. As expected, these subjects who were of normal weight in childhood but became overweight or obese as adults also had adverse CV risk profiles.

However, subjects who had been overweight or obese as children but became nonobese by young adulthood had CV risk profiles similar to those of subjects who had been of normal weight throughout their lives, Dr. Juonala and his associates wrote (N. Engl. J. Med. 2011;365:1876-85).

For example, the subjects who had been normal weight throughout the study and those who had been overweight or obese as children but became nonobese by young adulthood had no increased relative risk for developing type 2 diabetes, whereas those who were overweight or obese in childhood and remained so in young adulthood had a 5.4-fold increase in relative risk for developing type 2 diabetes.

Eighty-two percent of obese children were obese as adults, versus only 15% of normal-weight children.

Source ©annedde/iStockphoto.com

View on the News

Target the Right Population

Juonala et al. found that during an interval of almost 25 years, “only 15% of subjects who were of normal weight as children [became] obese as adults, whereas 65% of those who were overweight or obese as children and 82% of those who were obese as children were obese as adults,” said Dr. Albert P. Rocchini.

“These figures suggest that targeting interventions for obesity prevention and treatment specifically to children who are at high risk for becoming obese will prove to be a more valuable and more cost-effective strategy than targeting these interventions to whole populations of children,” he noted.

DR. ROCCHINI is in the pediatric cardiology division at C.S. Mott Children's Hospital and the University of Michigan, Ann Arbor. These remarks were taken from his editorial comment accompanying the report of Dr. Juonala et al. (N. Engl. J. Med. 2011;365:1927-9). Dr. Rocchini said he had no relevant financial disclosures.

Enhanced brief lifestyle counseling by a primary care team helped about one-third of obese patients lose and keep off 5% or more of their baseline weight after 2 years, according to a study published online Nov. 14 and simultaneously presented at the annual meeting of the American Heart Association.

However, many of the patients during the study's second year regained at least some of the lost weight, confirming “the problem of weight regain despite ongoing counseling for weight-loss maintenance,” the study's authors noted.

The intervention involved quarterly visits with a primary care physician, brief lifestyle coaching delivered monthly by a medical assistant, and the use of meal replacements or weight-loss medication.

The average weight loss of 4.7%, most of which was maintained for 2 years and was accompanied by improvements in some cardiovascular risk factors, was greater than that observed in other primary care trials, said Thomas A. Wadden, Ph.D., of the department of psychiatry at the University of Pennsylvania, Philadelphia, and his associates (N. Engl. J. Med. 2011 Nov. 14 [doi:10.1056/NEJMoa1109220]).

The results of the 2-year study of 390 obese patients demonstrate that “primary care physicians could help a considerable minority of obese persons achieve clinically meaningful weight loss, which they may not achieve if they were simply told to reduce their weight on their own,” the investigators noted.

Dr. Wadden and his colleagues conducted the POWER-UP (Practice-based Opportunities for Weight Reduction trial at the University of Pennsylvania) study at three primary care practices in urban settings and three in suburban settings. A total of 30 primary care physicians took part.

The study enrolled 311 women and 79 men, with a mean age of 52 years, a mean body weight of 108 kg, and a mean body mass index of 39 kg/m

The study participants all had the same dietary and activity goals but were given different levels of support to achieve them.

All were instructed to gradually increase their physical activity to 180 min/wk. Those who weighed less than 113 kg were prescribed a diet of 1,200-1,500 kcal/day, while those who were heavier were prescribed 1,500-1,800 kcal/day.

A total of 130 patients were randomly assigned to receive usual care, which consisted of quarterly visits in which their primary care physician spent 5-7 minutes discussing the weight-loss information and reviewing any weight change.

Another 131 were randomly assigned to that same care plus brief lifestyle counseling, in which they spent 10-15 min/mo with a medical assistant, called a “lifestyle coach,” who conducted a weigh-in, reviewed a diary of food intake, reviewed a physical activity diary, and delivered abbreviated lessons from the Diabetes Prevention Program.

Another 129 patients were randomly assigned to receive enhanced lifestyle counseling, which included that same intervention plus their choice of taking sibutramine, orlistat, or meal replacements under the guidance of the primary care physician. Sibutramine was withdrawn from the market during the trial, and patients in that group were switched to orlistat or meal replacements.

Patients taking meal replacements were instructed to substitute two meals and one snack every day with Slim-Fast shakes or meal bars for the first 4 months, and to replace one meal and one snack each day for the remainder of the study.

The primary outcome was weight loss at 2 years. Enhanced lifestyle counseling produced significantly greater weight loss (mean, 4.6 kg) than either lifestyle counseling (2.9 kg) or usual care (1.7 kg). Within the group receiving enhanced lifestyle counseling, there were no significant differences in weight loss among those taking meal replacements (67 patients), sibutramine (38 patients), or orlistat (24 patients), the investigators reported.

The differences among the groups were first evident at 6 months, and maximal weight loss was achieved at 12 months. Between year 1 and year 2, however, most patients regained at least some of the weight they had lost.

Secondary outcomes also were significantly better in the group that received enhanced lifestyle counseling than in the usual-care group, including the percentage of patients whose weight was at or below their baseline weight at 1 year (72.1% vs. 59.2%) and 2 years (67.4% vs. 53.1%); the percentages who lost 5% or more of their baseline weight at 1 year (47.3% vs. 24.6%) and 2 years (34.9% vs. 21.5%); and the percentages who lost 10% or more of their baseline weight at 1 year (25.6% vs. 3.9%) and 2 years (17.8% vs. 6.2%).

Patients who received enhanced lifestyle counseling showed significantly greater improvements in waist circumference, HDL cholesterol levels, and triglyceride levels, but not in LDL cholesterol levels or blood pressure, the researchers reported.

There were 73 hospitalizations for severe adverse events, with no significant differences among the three study groups.

Only three such events were deemed to be possibly related to the intervention: two cholecystectomies, and one case of syncope. In addition, sibutramine was discontinued in seven patients because of blood pressure elevation, tachycardia, or anxiety; and orlistat was discontinued in five patients because of gastrointestinal symptoms.

“Although our study has shown that primary care personnel can provide effective weight-management support, it has not addressed the more challenging question of who will pay for these or related weight-loss interventions,” the researchers noted.

Vitals

Source Elsevier Global Medical News

Enhanced brief lifestyle counseling by a primary care team helped about one-third of obese patients lose and keep off 5% or more of their baseline weight after 2 years, according to a study published online Nov. 14 and simultaneously presented at the annual meeting of the American Heart Association.

However, many of the patients during the study's second year regained at least some of the lost weight, confirming “the problem of weight regain despite ongoing counseling for weight-loss maintenance,” the study's authors noted.

The intervention involved quarterly visits with a primary care physician, brief lifestyle coaching delivered monthly by a medical assistant, and the use of meal replacements or weight-loss medication.

The average weight loss of 4.7%, most of which was maintained for 2 years and was accompanied by improvements in some cardiovascular risk factors, was greater than that observed in other primary care trials, said Thomas A. Wadden, Ph.D., of the department of psychiatry at the University of Pennsylvania, Philadelphia, and his associates (N. Engl. J. Med. 2011 Nov. 14 [doi:10.1056/NEJMoa1109220]).

The results of the 2-year study of 390 obese patients demonstrate that “primary care physicians could help a considerable minority of obese persons achieve clinically meaningful weight loss, which they may not achieve if they were simply told to reduce their weight on their own,” the investigators noted.

Dr. Wadden and his colleagues conducted the POWER-UP (Practice-based Opportunities for Weight Reduction trial at the University of Pennsylvania) study at three primary care practices in urban settings and three in suburban settings. A total of 30 primary care physicians took part.

The study enrolled 311 women and 79 men, with a mean age of 52 years, a mean body weight of 108 kg, and a mean body mass index of 39 kg/m

The study participants all had the same dietary and activity goals but were given different levels of support to achieve them.

All were instructed to gradually increase their physical activity to 180 min/wk. Those who weighed less than 113 kg were prescribed a diet of 1,200-1,500 kcal/day, while those who were heavier were prescribed 1,500-1,800 kcal/day.

A total of 130 patients were randomly assigned to receive usual care, which consisted of quarterly visits in which their primary care physician spent 5-7 minutes discussing the weight-loss information and reviewing any weight change.

Another 131 were randomly assigned to that same care plus brief lifestyle counseling, in which they spent 10-15 min/mo with a medical assistant, called a “lifestyle coach,” who conducted a weigh-in, reviewed a diary of food intake, reviewed a physical activity diary, and delivered abbreviated lessons from the Diabetes Prevention Program.

Another 129 patients were randomly assigned to receive enhanced lifestyle counseling, which included that same intervention plus their choice of taking sibutramine, orlistat, or meal replacements under the guidance of the primary care physician. Sibutramine was withdrawn from the market during the trial, and patients in that group were switched to orlistat or meal replacements.

Patients taking meal replacements were instructed to substitute two meals and one snack every day with Slim-Fast shakes or meal bars for the first 4 months, and to replace one meal and one snack each day for the remainder of the study.

The primary outcome was weight loss at 2 years. Enhanced lifestyle counseling produced significantly greater weight loss (mean, 4.6 kg) than either lifestyle counseling (2.9 kg) or usual care (1.7 kg). Within the group receiving enhanced lifestyle counseling, there were no significant differences in weight loss among those taking meal replacements (67 patients), sibutramine (38 patients), or orlistat (24 patients), the investigators reported.

The differences among the groups were first evident at 6 months, and maximal weight loss was achieved at 12 months. Between year 1 and year 2, however, most patients regained at least some of the weight they had lost.

Secondary outcomes also were significantly better in the group that received enhanced lifestyle counseling than in the usual-care group, including the percentage of patients whose weight was at or below their baseline weight at 1 year (72.1% vs. 59.2%) and 2 years (67.4% vs. 53.1%); the percentages who lost 5% or more of their baseline weight at 1 year (47.3% vs. 24.6%) and 2 years (34.9% vs. 21.5%); and the percentages who lost 10% or more of their baseline weight at 1 year (25.6% vs. 3.9%) and 2 years (17.8% vs. 6.2%).

Patients who received enhanced lifestyle counseling showed significantly greater improvements in waist circumference, HDL cholesterol levels, and triglyceride levels, but not in LDL cholesterol levels or blood pressure, the researchers reported.

There were 73 hospitalizations for severe adverse events, with no significant differences among the three study groups.

Only three such events were deemed to be possibly related to the intervention: two cholecystectomies, and one case of syncope. In addition, sibutramine was discontinued in seven patients because of blood pressure elevation, tachycardia, or anxiety; and orlistat was discontinued in five patients because of gastrointestinal symptoms.

“Although our study has shown that primary care personnel can provide effective weight-management support, it has not addressed the more challenging question of who will pay for these or related weight-loss interventions,” the researchers noted.

Vitals

Source Elsevier Global Medical News

Enhanced brief lifestyle counseling by a primary care team helped about one-third of obese patients lose and keep off 5% or more of their baseline weight after 2 years, according to a study published online Nov. 14 and simultaneously presented at the annual meeting of the American Heart Association.

However, many of the patients during the study's second year regained at least some of the lost weight, confirming “the problem of weight regain despite ongoing counseling for weight-loss maintenance,” the study's authors noted.

The intervention involved quarterly visits with a primary care physician, brief lifestyle coaching delivered monthly by a medical assistant, and the use of meal replacements or weight-loss medication.

The average weight loss of 4.7%, most of which was maintained for 2 years and was accompanied by improvements in some cardiovascular risk factors, was greater than that observed in other primary care trials, said Thomas A. Wadden, Ph.D., of the department of psychiatry at the University of Pennsylvania, Philadelphia, and his associates (N. Engl. J. Med. 2011 Nov. 14 [doi:10.1056/NEJMoa1109220]).

The results of the 2-year study of 390 obese patients demonstrate that “primary care physicians could help a considerable minority of obese persons achieve clinically meaningful weight loss, which they may not achieve if they were simply told to reduce their weight on their own,” the investigators noted.

Dr. Wadden and his colleagues conducted the POWER-UP (Practice-based Opportunities for Weight Reduction trial at the University of Pennsylvania) study at three primary care practices in urban settings and three in suburban settings. A total of 30 primary care physicians took part.

The study enrolled 311 women and 79 men, with a mean age of 52 years, a mean body weight of 108 kg, and a mean body mass index of 39 kg/m

The study participants all had the same dietary and activity goals but were given different levels of support to achieve them.

All were instructed to gradually increase their physical activity to 180 min/wk. Those who weighed less than 113 kg were prescribed a diet of 1,200-1,500 kcal/day, while those who were heavier were prescribed 1,500-1,800 kcal/day.

A total of 130 patients were randomly assigned to receive usual care, which consisted of quarterly visits in which their primary care physician spent 5-7 minutes discussing the weight-loss information and reviewing any weight change.

Another 131 were randomly assigned to that same care plus brief lifestyle counseling, in which they spent 10-15 min/mo with a medical assistant, called a “lifestyle coach,” who conducted a weigh-in, reviewed a diary of food intake, reviewed a physical activity diary, and delivered abbreviated lessons from the Diabetes Prevention Program.

Another 129 patients were randomly assigned to receive enhanced lifestyle counseling, which included that same intervention plus their choice of taking sibutramine, orlistat, or meal replacements under the guidance of the primary care physician. Sibutramine was withdrawn from the market during the trial, and patients in that group were switched to orlistat or meal replacements.

Patients taking meal replacements were instructed to substitute two meals and one snack every day with Slim-Fast shakes or meal bars for the first 4 months, and to replace one meal and one snack each day for the remainder of the study.

The primary outcome was weight loss at 2 years. Enhanced lifestyle counseling produced significantly greater weight loss (mean, 4.6 kg) than either lifestyle counseling (2.9 kg) or usual care (1.7 kg). Within the group receiving enhanced lifestyle counseling, there were no significant differences in weight loss among those taking meal replacements (67 patients), sibutramine (38 patients), or orlistat (24 patients), the investigators reported.

The differences among the groups were first evident at 6 months, and maximal weight loss was achieved at 12 months. Between year 1 and year 2, however, most patients regained at least some of the weight they had lost.

Secondary outcomes also were significantly better in the group that received enhanced lifestyle counseling than in the usual-care group, including the percentage of patients whose weight was at or below their baseline weight at 1 year (72.1% vs. 59.2%) and 2 years (67.4% vs. 53.1%); the percentages who lost 5% or more of their baseline weight at 1 year (47.3% vs. 24.6%) and 2 years (34.9% vs. 21.5%); and the percentages who lost 10% or more of their baseline weight at 1 year (25.6% vs. 3.9%) and 2 years (17.8% vs. 6.2%).

Patients who received enhanced lifestyle counseling showed significantly greater improvements in waist circumference, HDL cholesterol levels, and triglyceride levels, but not in LDL cholesterol levels or blood pressure, the researchers reported.

There were 73 hospitalizations for severe adverse events, with no significant differences among the three study groups.

Only three such events were deemed to be possibly related to the intervention: two cholecystectomies, and one case of syncope. In addition, sibutramine was discontinued in seven patients because of blood pressure elevation, tachycardia, or anxiety; and orlistat was discontinued in five patients because of gastrointestinal symptoms.

“Although our study has shown that primary care personnel can provide effective weight-management support, it has not addressed the more challenging question of who will pay for these or related weight-loss interventions,” the researchers noted.

Vitals

Source Elsevier Global Medical News

Low-dose interleukin-2 induced remission of the main symptoms of hepatitis C virus–related vasculitis in 8 of 10 patients participating in a phase I/phase II clinical trial, according to results reported in the Dec. 1 issue of the New England Journal of Medicine.

The remission of purpura, arthralgia, and nephropathy was accompanied by a 420% increase in the potently suppressive regulatory T cells known as Tregs, which are abnormally decreased in patients who have mixed cryoglobulinemic vasculitis induced by chronic infection with hepatitis C virus, said Dr. David Saadoun of the Université Pierre et Marie Curie, Paris, and his associates (N. Engl. J. Med. 2011;365:2067-77).

The interleukin-2 immunotherapy did not activate other T cells and did not cause any adverse events related to immune activation. The treatment appeared to reduce HCV viral load modestly.

"Further studies are needed to determine whether this intervention could be further modified and whether it would also be effective in the treatment of other inflammatory and autoimmune diseases, such as atherosclerosis or type 1 diabetes," the authors noted.

Dr. Saadoun and his colleagues recently found "a quantitative defect in Tregs" among patients with HCV-induced mixed cryoglobulinemia vasculitis, which was reversed when the vasculitis in those patients was cured.

"We therefore reasoned that induction of Tregs could have beneficial effects for patients with HCV-induced vasculitis that is resistant to HCV therapy," the researchers noted. That prompted them to conduct an open-label phase I/ IIa trial to assess the safety as well as the immunologic and clinical effects of repeated administration of low-dose interleukin-2 in HCV-infected patients who had associated autoimmunity, they added.

The prospective, single-center study included five men and five women with a median age of 58.5 years and a mean duration of HCV infection of 30 years. Eight patients had purpura, eight had neuropathy, six had asthenia, three had arthralgia, and one had kidney involvement. The vasculitis had been refractory to conventional antiviral therapy, rituximab therapy, or both.

The patients underwent an initial 5-day course of subcutaneous interleukin-2 injections (1.5 million IU per day, or half the target dose) with safety monitoring. "This dose led to a significant increase of Treg percentages in all patients; adverse events were minor and transient," the researchers said.

After a washout period, all the subjects received three more 5-day courses at the target dose of 3 million IU per day, separated by washout periods. During each treatment period, the percentage of Tregs increased. "We do not know whether this increase was consequent to the increased dosage, to the repetition of treatment, or both," the investigators noted.

The researchers selected the primary end point – an absolute increase of 4 percentage points in the proportion of circulating Tregs at the end of treatment – because it was the mean increase seen in earlier patients whose vasculitis was cured by standard HCV treatment. All 10 patients reached that end point.

"Notably, Treg proportions had increased by approximately a factor of 2 after the first 5-day course of 1.5 million IU of interleukin-2 per day, continued to increase during the washout period between courses, and were further boosted after the administration of subsequent courses," Dr. Saadoun and his associates said.

The median peak value corresponded to a 420% increase in Tregs. The proportion of Tregs remained significantly elevated for 130-150 days of follow-up, at twice the baseline value. That level is within the normal range for healthy adults.

Tests of the functionality of the Tregs induced by the interleukin-2 therapy demonstrated that they were "highly suppressive," the study authors said.

Serum levels of cryoglobulin decreased during treatment, and the HCV viral load decreased modestly but significantly, even though patients were not receiving antiviral therapy.

Concomitantly with those biologic improvements, the HCV-induced mixed cryoglobulinemic vasculitis also improved in 8 of 10 patients. Purpura resolved in all eight patients who had had it at baseline, and arthralgia resolved in all three patients who had had it at baseline. Neuropathy remitted in all but two patients. Measures of kidney function normalized in the one patient who had had nephropathy.

Clinical improvement was noted after the first or second course of treatment, simultaneously with the peak increases in Tregs.

Only the two patients who had presented with neuropathy as their sole vasculitis symptom failed to show clinical improvement, the investigators said.

The French Agency for Research on AIDS and Viral Hepatitis funded the study, with additional support from the authors’ institutions. Dr. Saadoun had no disclosures but his associates reported ties to numerous industry sources.

Low-dose interleukin-2 induced remission of the main symptoms of hepatitis C virus–related vasculitis in 8 of 10 patients participating in a phase I/phase II clinical trial, according to results reported in the Dec. 1 issue of the New England Journal of Medicine.

The remission of purpura, arthralgia, and nephropathy was accompanied by a 420% increase in the potently suppressive regulatory T cells known as Tregs, which are abnormally decreased in patients who have mixed cryoglobulinemic vasculitis induced by chronic infection with hepatitis C virus, said Dr. David Saadoun of the Université Pierre et Marie Curie, Paris, and his associates (N. Engl. J. Med. 2011;365:2067-77).

The interleukin-2 immunotherapy did not activate other T cells and did not cause any adverse events related to immune activation. The treatment appeared to reduce HCV viral load modestly.

"Further studies are needed to determine whether this intervention could be further modified and whether it would also be effective in the treatment of other inflammatory and autoimmune diseases, such as atherosclerosis or type 1 diabetes," the authors noted.

Dr. Saadoun and his colleagues recently found "a quantitative defect in Tregs" among patients with HCV-induced mixed cryoglobulinemia vasculitis, which was reversed when the vasculitis in those patients was cured.

"We therefore reasoned that induction of Tregs could have beneficial effects for patients with HCV-induced vasculitis that is resistant to HCV therapy," the researchers noted. That prompted them to conduct an open-label phase I/ IIa trial to assess the safety as well as the immunologic and clinical effects of repeated administration of low-dose interleukin-2 in HCV-infected patients who had associated autoimmunity, they added.

The prospective, single-center study included five men and five women with a median age of 58.5 years and a mean duration of HCV infection of 30 years. Eight patients had purpura, eight had neuropathy, six had asthenia, three had arthralgia, and one had kidney involvement. The vasculitis had been refractory to conventional antiviral therapy, rituximab therapy, or both.

The patients underwent an initial 5-day course of subcutaneous interleukin-2 injections (1.5 million IU per day, or half the target dose) with safety monitoring. "This dose led to a significant increase of Treg percentages in all patients; adverse events were minor and transient," the researchers said.

After a washout period, all the subjects received three more 5-day courses at the target dose of 3 million IU per day, separated by washout periods. During each treatment period, the percentage of Tregs increased. "We do not know whether this increase was consequent to the increased dosage, to the repetition of treatment, or both," the investigators noted.

The researchers selected the primary end point – an absolute increase of 4 percentage points in the proportion of circulating Tregs at the end of treatment – because it was the mean increase seen in earlier patients whose vasculitis was cured by standard HCV treatment. All 10 patients reached that end point.

"Notably, Treg proportions had increased by approximately a factor of 2 after the first 5-day course of 1.5 million IU of interleukin-2 per day, continued to increase during the washout period between courses, and were further boosted after the administration of subsequent courses," Dr. Saadoun and his associates said.

The median peak value corresponded to a 420% increase in Tregs. The proportion of Tregs remained significantly elevated for 130-150 days of follow-up, at twice the baseline value. That level is within the normal range for healthy adults.

Tests of the functionality of the Tregs induced by the interleukin-2 therapy demonstrated that they were "highly suppressive," the study authors said.

Serum levels of cryoglobulin decreased during treatment, and the HCV viral load decreased modestly but significantly, even though patients were not receiving antiviral therapy.

Concomitantly with those biologic improvements, the HCV-induced mixed cryoglobulinemic vasculitis also improved in 8 of 10 patients. Purpura resolved in all eight patients who had had it at baseline, and arthralgia resolved in all three patients who had had it at baseline. Neuropathy remitted in all but two patients. Measures of kidney function normalized in the one patient who had had nephropathy.

Clinical improvement was noted after the first or second course of treatment, simultaneously with the peak increases in Tregs.

Only the two patients who had presented with neuropathy as their sole vasculitis symptom failed to show clinical improvement, the investigators said.

The French Agency for Research on AIDS and Viral Hepatitis funded the study, with additional support from the authors’ institutions. Dr. Saadoun had no disclosures but his associates reported ties to numerous industry sources.

Low-dose interleukin-2 induced remission of the main symptoms of hepatitis C virus–related vasculitis in 8 of 10 patients participating in a phase I/phase II clinical trial, according to results reported in the Dec. 1 issue of the New England Journal of Medicine.

The remission of purpura, arthralgia, and nephropathy was accompanied by a 420% increase in the potently suppressive regulatory T cells known as Tregs, which are abnormally decreased in patients who have mixed cryoglobulinemic vasculitis induced by chronic infection with hepatitis C virus, said Dr. David Saadoun of the Université Pierre et Marie Curie, Paris, and his associates (N. Engl. J. Med. 2011;365:2067-77).

The interleukin-2 immunotherapy did not activate other T cells and did not cause any adverse events related to immune activation. The treatment appeared to reduce HCV viral load modestly.

"Further studies are needed to determine whether this intervention could be further modified and whether it would also be effective in the treatment of other inflammatory and autoimmune diseases, such as atherosclerosis or type 1 diabetes," the authors noted.

Dr. Saadoun and his colleagues recently found "a quantitative defect in Tregs" among patients with HCV-induced mixed cryoglobulinemia vasculitis, which was reversed when the vasculitis in those patients was cured.

"We therefore reasoned that induction of Tregs could have beneficial effects for patients with HCV-induced vasculitis that is resistant to HCV therapy," the researchers noted. That prompted them to conduct an open-label phase I/ IIa trial to assess the safety as well as the immunologic and clinical effects of repeated administration of low-dose interleukin-2 in HCV-infected patients who had associated autoimmunity, they added.

The prospective, single-center study included five men and five women with a median age of 58.5 years and a mean duration of HCV infection of 30 years. Eight patients had purpura, eight had neuropathy, six had asthenia, three had arthralgia, and one had kidney involvement. The vasculitis had been refractory to conventional antiviral therapy, rituximab therapy, or both.

The patients underwent an initial 5-day course of subcutaneous interleukin-2 injections (1.5 million IU per day, or half the target dose) with safety monitoring. "This dose led to a significant increase of Treg percentages in all patients; adverse events were minor and transient," the researchers said.

After a washout period, all the subjects received three more 5-day courses at the target dose of 3 million IU per day, separated by washout periods. During each treatment period, the percentage of Tregs increased. "We do not know whether this increase was consequent to the increased dosage, to the repetition of treatment, or both," the investigators noted.

The researchers selected the primary end point – an absolute increase of 4 percentage points in the proportion of circulating Tregs at the end of treatment – because it was the mean increase seen in earlier patients whose vasculitis was cured by standard HCV treatment. All 10 patients reached that end point.

"Notably, Treg proportions had increased by approximately a factor of 2 after the first 5-day course of 1.5 million IU of interleukin-2 per day, continued to increase during the washout period between courses, and were further boosted after the administration of subsequent courses," Dr. Saadoun and his associates said.

The median peak value corresponded to a 420% increase in Tregs. The proportion of Tregs remained significantly elevated for 130-150 days of follow-up, at twice the baseline value. That level is within the normal range for healthy adults.

Tests of the functionality of the Tregs induced by the interleukin-2 therapy demonstrated that they were "highly suppressive," the study authors said.

Serum levels of cryoglobulin decreased during treatment, and the HCV viral load decreased modestly but significantly, even though patients were not receiving antiviral therapy.

Concomitantly with those biologic improvements, the HCV-induced mixed cryoglobulinemic vasculitis also improved in 8 of 10 patients. Purpura resolved in all eight patients who had had it at baseline, and arthralgia resolved in all three patients who had had it at baseline. Neuropathy remitted in all but two patients. Measures of kidney function normalized in the one patient who had had nephropathy.

Clinical improvement was noted after the first or second course of treatment, simultaneously with the peak increases in Tregs.

Only the two patients who had presented with neuropathy as their sole vasculitis symptom failed to show clinical improvement, the investigators said.

The French Agency for Research on AIDS and Viral Hepatitis funded the study, with additional support from the authors’ institutions. Dr. Saadoun had no disclosures but his associates reported ties to numerous industry sources.

Fewer than 10% of cases meet the recommended 30-minute limit between a STEMI patient’s presentation to an emergency department and his or her discharge for transfer to a facility that can perform percutaneous coronary intervention, according to a report in the Nov. 28 issue of Archives of Internal Medicine.

"In the first national assessment of performance in this critical phase of treatment, we find that median times are more than double the 30 minutes recommended by many experts, with DIDO [door-in to door-out] times exceeding 1 hour for more than half of patients," said Jeph Herrin, Ph.D., of the cardiovascular medicine section at Yale University, New Haven, Conn., and his associates.

In addition, DIDO times vary markedly by patient characteristics such as age, sex, and race, and by hospital factors including geographic location.

"Our findings suggest that many patients may have benefitted from fibrinolytic therapy at the transferring hospital rather than from transfer for primary PCI," they noted.

Dr. Herrin and his colleagues examined DIDO times for patients with ST-elevation myocardial infarction (STEMI) across the United States, because "very little is known about how frequently this goal is met nationally." To do so, they used data collected by the Centers for Medicare and Medicaid Services (CMS), which requires that hospitals report the information for all patients in order to receive reimbursement for those eligible for Medicare or Medicaid. (The CMS is developing a new performance measure for DIDO times.)

After excluding hospitals that reported fewer than 5 PCI-transfer patients during the study year (2009), the investigators included 13,776 patients who presented to 1,034 hospitals with STEMI and were transferred to another hospital for PCI. The median DIDO time was 64 minutes (range, 43-104 minutes).

Only 9.7% of patients were discharged for transfer within 30 minutes, and a full 31% were not discharged for transfer until 90 minutes had passed, the investigators said (Arch. Intern. Med. 2011;171:1879-86).

Nationally, only 13 hospitals (1.3%) had median DIDO times of 30 minutes or less. Times were significantly longer if hospitals had fewer than 100 or more than 150 beds; were government owned; were rural; had fewer than 10 such cases per year; or were located in the Mountain, West South Central, or Midatlantic regions of the country.

Hospitals that transfer many such patients are more likely to have systems in place to facilitate the transfers. Rural hospitals may be hindered by lack of transportation to the PCI-capable facility, including long wait times for helicopters, said Dr. Herrin, who is also at the Health Research and Educational Trust, Chicago, and his colleagues.

Patient factors also were found to be associated with DIDO time. The time for women was a mean of 8.9 minutes longer than for men, the time for African Americans was a median of 9.1 minutes longer than for whites, and the time for young adults (aged 18-35 years) and the elderly (over age 75) was more than 16 minutes longer than for patients aged 46-55 years.

In contrast, DIDO time did not vary according to time of arrival at the emergency department, most likely because even EDs at smaller hospitals are staffed at a similar level around the clock.

Overall, although there may have been many "legitimate" patient-centered reasons for delays in DIDO times, "most patients are transferred after twice the recommended time," the researchers said. "Improvement efforts should focus on understanding and reducing this delay."

This study was supported by the CMS and the National Heart, Lung, and Blood Institute. The corresponding author, Dr. Harlan M. Krumholz of Yale University, reported ties to United Healthcare and Medtronic.

Fewer than 10% of cases meet the recommended 30-minute limit between a STEMI patient’s presentation to an emergency department and his or her discharge for transfer to a facility that can perform percutaneous coronary intervention, according to a report in the Nov. 28 issue of Archives of Internal Medicine.

"In the first national assessment of performance in this critical phase of treatment, we find that median times are more than double the 30 minutes recommended by many experts, with DIDO [door-in to door-out] times exceeding 1 hour for more than half of patients," said Jeph Herrin, Ph.D., of the cardiovascular medicine section at Yale University, New Haven, Conn., and his associates.

In addition, DIDO times vary markedly by patient characteristics such as age, sex, and race, and by hospital factors including geographic location.

"Our findings suggest that many patients may have benefitted from fibrinolytic therapy at the transferring hospital rather than from transfer for primary PCI," they noted.

Dr. Herrin and his colleagues examined DIDO times for patients with ST-elevation myocardial infarction (STEMI) across the United States, because "very little is known about how frequently this goal is met nationally." To do so, they used data collected by the Centers for Medicare and Medicaid Services (CMS), which requires that hospitals report the information for all patients in order to receive reimbursement for those eligible for Medicare or Medicaid. (The CMS is developing a new performance measure for DIDO times.)

After excluding hospitals that reported fewer than 5 PCI-transfer patients during the study year (2009), the investigators included 13,776 patients who presented to 1,034 hospitals with STEMI and were transferred to another hospital for PCI. The median DIDO time was 64 minutes (range, 43-104 minutes).

Only 9.7% of patients were discharged for transfer within 30 minutes, and a full 31% were not discharged for transfer until 90 minutes had passed, the investigators said (Arch. Intern. Med. 2011;171:1879-86).

Nationally, only 13 hospitals (1.3%) had median DIDO times of 30 minutes or less. Times were significantly longer if hospitals had fewer than 100 or more than 150 beds; were government owned; were rural; had fewer than 10 such cases per year; or were located in the Mountain, West South Central, or Midatlantic regions of the country.

Hospitals that transfer many such patients are more likely to have systems in place to facilitate the transfers. Rural hospitals may be hindered by lack of transportation to the PCI-capable facility, including long wait times for helicopters, said Dr. Herrin, who is also at the Health Research and Educational Trust, Chicago, and his colleagues.

Patient factors also were found to be associated with DIDO time. The time for women was a mean of 8.9 minutes longer than for men, the time for African Americans was a median of 9.1 minutes longer than for whites, and the time for young adults (aged 18-35 years) and the elderly (over age 75) was more than 16 minutes longer than for patients aged 46-55 years.

In contrast, DIDO time did not vary according to time of arrival at the emergency department, most likely because even EDs at smaller hospitals are staffed at a similar level around the clock.

Overall, although there may have been many "legitimate" patient-centered reasons for delays in DIDO times, "most patients are transferred after twice the recommended time," the researchers said. "Improvement efforts should focus on understanding and reducing this delay."

This study was supported by the CMS and the National Heart, Lung, and Blood Institute. The corresponding author, Dr. Harlan M. Krumholz of Yale University, reported ties to United Healthcare and Medtronic.

Fewer than 10% of cases meet the recommended 30-minute limit between a STEMI patient’s presentation to an emergency department and his or her discharge for transfer to a facility that can perform percutaneous coronary intervention, according to a report in the Nov. 28 issue of Archives of Internal Medicine.

"In the first national assessment of performance in this critical phase of treatment, we find that median times are more than double the 30 minutes recommended by many experts, with DIDO [door-in to door-out] times exceeding 1 hour for more than half of patients," said Jeph Herrin, Ph.D., of the cardiovascular medicine section at Yale University, New Haven, Conn., and his associates.

In addition, DIDO times vary markedly by patient characteristics such as age, sex, and race, and by hospital factors including geographic location.

"Our findings suggest that many patients may have benefitted from fibrinolytic therapy at the transferring hospital rather than from transfer for primary PCI," they noted.

Dr. Herrin and his colleagues examined DIDO times for patients with ST-elevation myocardial infarction (STEMI) across the United States, because "very little is known about how frequently this goal is met nationally." To do so, they used data collected by the Centers for Medicare and Medicaid Services (CMS), which requires that hospitals report the information for all patients in order to receive reimbursement for those eligible for Medicare or Medicaid. (The CMS is developing a new performance measure for DIDO times.)

After excluding hospitals that reported fewer than 5 PCI-transfer patients during the study year (2009), the investigators included 13,776 patients who presented to 1,034 hospitals with STEMI and were transferred to another hospital for PCI. The median DIDO time was 64 minutes (range, 43-104 minutes).

Only 9.7% of patients were discharged for transfer within 30 minutes, and a full 31% were not discharged for transfer until 90 minutes had passed, the investigators said (Arch. Intern. Med. 2011;171:1879-86).

Nationally, only 13 hospitals (1.3%) had median DIDO times of 30 minutes or less. Times were significantly longer if hospitals had fewer than 100 or more than 150 beds; were government owned; were rural; had fewer than 10 such cases per year; or were located in the Mountain, West South Central, or Midatlantic regions of the country.

Hospitals that transfer many such patients are more likely to have systems in place to facilitate the transfers. Rural hospitals may be hindered by lack of transportation to the PCI-capable facility, including long wait times for helicopters, said Dr. Herrin, who is also at the Health Research and Educational Trust, Chicago, and his colleagues.

Patient factors also were found to be associated with DIDO time. The time for women was a mean of 8.9 minutes longer than for men, the time for African Americans was a median of 9.1 minutes longer than for whites, and the time for young adults (aged 18-35 years) and the elderly (over age 75) was more than 16 minutes longer than for patients aged 46-55 years.

In contrast, DIDO time did not vary according to time of arrival at the emergency department, most likely because even EDs at smaller hospitals are staffed at a similar level around the clock.

Overall, although there may have been many "legitimate" patient-centered reasons for delays in DIDO times, "most patients are transferred after twice the recommended time," the researchers said. "Improvement efforts should focus on understanding and reducing this delay."

This study was supported by the CMS and the National Heart, Lung, and Blood Institute. The corresponding author, Dr. Harlan M. Krumholz of Yale University, reported ties to United Healthcare and Medtronic.

Nearly 10% of patients who underwent percutaneous coronary interventions during a 10-year period were readmitted to the hospital within 30 days, according to a single-center study published online Nov. 28 in Archives of Internal Medicine.

And those who were readmitted had approximately twice the risk of dying within a year, compared with those who were not readmitted, said Dr. Farhan J. Khawaja of the division of cardiovascular diseases at the Mayo Clinic, Rochester, Minn., and associates.

Thirty-day readmission rates after PCI are to be publicly reported and will be tied to hospital reimbursement, so there is great interest in determining what those rates are and how to improve them. "Prior to this study, knowledge of readmission rates after PCI was limited to administrative data from Medicare patients," who account for less than half of all PCI procedures, Dr. Khawaja and colleagues said.

They analyzed data in the Mayo Clinic’s PCI registry concerning 15,498 hospitalizations for PCI performed between 1998 and 2008 electively or for acute coronary syndromes. Overall, 1,459 cases (9.4%) required readmission within 30 days (Arch. Intern. Med. 2011 Nov. 28 [doi:10.1001/archinternmed.2011.569]).

There were 106 deaths (0.68%) within 30 days, including 33 that were associated with readmission and 73 that were not.

Most readmissions were for cardiac-related reasons. A total of 4.2% of patients were readmitted for repeat PCI, and another 4.7% were readmitted for coronary artery bypass grafting.

Thirty-day readmission was associated with significantly higher mortality. Patients who were readmitted had a 12-month mortality of just under 8%, compared with just under 4% for those who were not readmitted.

After multivariate analysis, demographic factors that were found to be associated with readmission were female sex, Medicare coverage (as opposed to any other type of insurance), and less than a high school education. None of these are modifiable, the investigators noted.

Other factors that were found to be associated with readmission were the presence of heart failure at presentation; concomitant renal disease, chronic obstructive pulmonary disease, peptic ulcer, or metastatic cancer; and a length of stay of more than 3 days. These variables also are not modifiable.

In previous studies, a lack of early follow-up care had been associated with increased readmissions, in part because patients may not fully understand and comply with maintenance therapies. In this study, "gaps in transitions in care from the inpatient to the outpatient context may account for many of the observed readmissions, especially among Medicare, Medicaid, and uninsured patients, who may experience difficulty in accessing outpatient care," Dr. Khawaja and associates said.

"The educational component of follow-up cannot be underestimated because in one study, less than half of patients were able to list their diagnoses and the names, purposes, and adverse effects of their medications at the time of discharge," the investigators noted.

Given that the factors associated with readmission are not modifiable and that follow-up care is modifiable, "interventions to improve access and follow-up care should be studied to assess [their] impact on readmission rates," the researchers said.

This study was not designed to determine whether any of the observed associations were causal. There also were no data on follow-up visits, medication compliance, health literacy, patient frailty, or other barriers to health care access, they said.

This study was funded by the Mayo Clinic’s division of cardiovascular diseases. One of Dr. Khawaja’s associates reported ties to United Healthcare, Medtronic, and the National Heart, Lung, and Blood Institute.

Nearly 10% of patients who underwent percutaneous coronary interventions during a 10-year period were readmitted to the hospital within 30 days, according to a single-center study published online Nov. 28 in Archives of Internal Medicine.

And those who were readmitted had approximately twice the risk of dying within a year, compared with those who were not readmitted, said Dr. Farhan J. Khawaja of the division of cardiovascular diseases at the Mayo Clinic, Rochester, Minn., and associates.

Thirty-day readmission rates after PCI are to be publicly reported and will be tied to hospital reimbursement, so there is great interest in determining what those rates are and how to improve them. "Prior to this study, knowledge of readmission rates after PCI was limited to administrative data from Medicare patients," who account for less than half of all PCI procedures, Dr. Khawaja and colleagues said.

They analyzed data in the Mayo Clinic’s PCI registry concerning 15,498 hospitalizations for PCI performed between 1998 and 2008 electively or for acute coronary syndromes. Overall, 1,459 cases (9.4%) required readmission within 30 days (Arch. Intern. Med. 2011 Nov. 28 [doi:10.1001/archinternmed.2011.569]).

There were 106 deaths (0.68%) within 30 days, including 33 that were associated with readmission and 73 that were not.

Most readmissions were for cardiac-related reasons. A total of 4.2% of patients were readmitted for repeat PCI, and another 4.7% were readmitted for coronary artery bypass grafting.

Thirty-day readmission was associated with significantly higher mortality. Patients who were readmitted had a 12-month mortality of just under 8%, compared with just under 4% for those who were not readmitted.

After multivariate analysis, demographic factors that were found to be associated with readmission were female sex, Medicare coverage (as opposed to any other type of insurance), and less than a high school education. None of these are modifiable, the investigators noted.

Other factors that were found to be associated with readmission were the presence of heart failure at presentation; concomitant renal disease, chronic obstructive pulmonary disease, peptic ulcer, or metastatic cancer; and a length of stay of more than 3 days. These variables also are not modifiable.

In previous studies, a lack of early follow-up care had been associated with increased readmissions, in part because patients may not fully understand and comply with maintenance therapies. In this study, "gaps in transitions in care from the inpatient to the outpatient context may account for many of the observed readmissions, especially among Medicare, Medicaid, and uninsured patients, who may experience difficulty in accessing outpatient care," Dr. Khawaja and associates said.

"The educational component of follow-up cannot be underestimated because in one study, less than half of patients were able to list their diagnoses and the names, purposes, and adverse effects of their medications at the time of discharge," the investigators noted.

Given that the factors associated with readmission are not modifiable and that follow-up care is modifiable, "interventions to improve access and follow-up care should be studied to assess [their] impact on readmission rates," the researchers said.

This study was not designed to determine whether any of the observed associations were causal. There also were no data on follow-up visits, medication compliance, health literacy, patient frailty, or other barriers to health care access, they said.

This study was funded by the Mayo Clinic’s division of cardiovascular diseases. One of Dr. Khawaja’s associates reported ties to United Healthcare, Medtronic, and the National Heart, Lung, and Blood Institute.

Nearly 10% of patients who underwent percutaneous coronary interventions during a 10-year period were readmitted to the hospital within 30 days, according to a single-center study published online Nov. 28 in Archives of Internal Medicine.

And those who were readmitted had approximately twice the risk of dying within a year, compared with those who were not readmitted, said Dr. Farhan J. Khawaja of the division of cardiovascular diseases at the Mayo Clinic, Rochester, Minn., and associates.

Thirty-day readmission rates after PCI are to be publicly reported and will be tied to hospital reimbursement, so there is great interest in determining what those rates are and how to improve them. "Prior to this study, knowledge of readmission rates after PCI was limited to administrative data from Medicare patients," who account for less than half of all PCI procedures, Dr. Khawaja and colleagues said.

They analyzed data in the Mayo Clinic’s PCI registry concerning 15,498 hospitalizations for PCI performed between 1998 and 2008 electively or for acute coronary syndromes. Overall, 1,459 cases (9.4%) required readmission within 30 days (Arch. Intern. Med. 2011 Nov. 28 [doi:10.1001/archinternmed.2011.569]).

There were 106 deaths (0.68%) within 30 days, including 33 that were associated with readmission and 73 that were not.

Most readmissions were for cardiac-related reasons. A total of 4.2% of patients were readmitted for repeat PCI, and another 4.7% were readmitted for coronary artery bypass grafting.

Thirty-day readmission was associated with significantly higher mortality. Patients who were readmitted had a 12-month mortality of just under 8%, compared with just under 4% for those who were not readmitted.

After multivariate analysis, demographic factors that were found to be associated with readmission were female sex, Medicare coverage (as opposed to any other type of insurance), and less than a high school education. None of these are modifiable, the investigators noted.

Other factors that were found to be associated with readmission were the presence of heart failure at presentation; concomitant renal disease, chronic obstructive pulmonary disease, peptic ulcer, or metastatic cancer; and a length of stay of more than 3 days. These variables also are not modifiable.

In previous studies, a lack of early follow-up care had been associated with increased readmissions, in part because patients may not fully understand and comply with maintenance therapies. In this study, "gaps in transitions in care from the inpatient to the outpatient context may account for many of the observed readmissions, especially among Medicare, Medicaid, and uninsured patients, who may experience difficulty in accessing outpatient care," Dr. Khawaja and associates said.

"The educational component of follow-up cannot be underestimated because in one study, less than half of patients were able to list their diagnoses and the names, purposes, and adverse effects of their medications at the time of discharge," the investigators noted.

Given that the factors associated with readmission are not modifiable and that follow-up care is modifiable, "interventions to improve access and follow-up care should be studied to assess [their] impact on readmission rates," the researchers said.

This study was not designed to determine whether any of the observed associations were causal. There also were no data on follow-up visits, medication compliance, health literacy, patient frailty, or other barriers to health care access, they said.

This study was funded by the Mayo Clinic’s division of cardiovascular diseases. One of Dr. Khawaja’s associates reported ties to United Healthcare, Medtronic, and the National Heart, Lung, and Blood Institute.

High urinary sodium excretion, a proxy for high sodium intake, was associated with an increased risk of cardiovascular mortality, myocardial infarction, stroke, and hospitalization for heart failure in a study in the Nov. 23/30 JAMA.

However, low urinary sodium excretion also was associated with increased risk of cardiovascular mortality and hospitalization for heart failure.

"Our findings emphasize the burden of CV disease associated with excess sodium intake and the importance of population-based programs to reduce sodium intake in populations consuming high-sodium diets," Dr. Martin J. O’Donnell of the Population Health Research Institute, McMaster University, Hamilton, Ont., and his associates.

© Georges Lievre / Fotolia.com

Importantly, the association between sodium intake and adverse CV outcomes did not become significant until intake exceeded 6.5 g/day. This threshold is higher than that recommended by the World Health Organization and by many national guidelines. This highlights "the urgent need to establish a safe range for sodium intake," they noted.

"We found a J-shaped association between estimated sodium excretion and CV events," the researchers noted.

Compared with the "moderate" sodium excretion of 4-5.99 g/day, both higher (more than 7 g/day) and lower (less than 3 g/day) sodium excretion were linked to adverse CV events.

They examined the relationship between sodium intake and CV events using data from two large clinical trials in which patients at high risk for CV events provided urinary samples and were followed for a median of 56 months. Data from the two trials were combined because both recruited subjects from the same areas during the same time period (2001-2004) using the same eligibility criteria and the same methods of obtaining baseline clinical data and monitoring outcomes.

A total of 28,880 study subjects followed at 733 medical centers in 40 countries were included. The subjects were aged 55 and older and either had established CV disease or high-risk diabetes.

Sodium and potassium concentrations were determined from a single morning fasting urine sample from each subject, and this was used to estimate 24-hour sodium and potassium excretion. Overall, the mean estimated 24-hour sodium excretion, a proxy for sodium intake, was 4.77 g, and potassium excretion, a proxy for potassium intake, was 2.19 g.

The composite outcome of CV death, MI, stroke, and hospitalization for heart failure occurred in 4,729 study subjects (16%) during follow-up through 2008. Overall mortality was 12%, the rate of MI was 5%, that of stroke and heart failure hospitalization were each about 4%.

Compared with the moderate excretion of 4-5.99 g/day, higher excretion (more than 7 g/day) was associated with a hazard ratio of 1.15-1.49 for the composite end point. And those with lower excretion (less than 3 g/day), had a hazard ratio of 1.16-1.21 for the composite end point.

In addition, high sodium excretion was significantly associated with each of the individual components of this composite outcome, Dr. O’Donnell and his colleagues said (JAMA 2011;306:2229-38).

"We found a J-shaped association between estimated sodium excretion and CV events."

Lower sodium excretion also was associated with increased risk of heart failure hospitalization.

These results remained robust in several sensitivity and subgroup analyses.

No association was found between potassium excretion and any of the CV outcomes, except that higher potassium excretion was related to a reduced risk of stroke.

"Clearly, large randomized controlled trials evaluating the effect of reduced sodium intake ... on CV outcomes in those with moderate sodium intake are needed urgently. Pending the results of such trials, a more cautious approach to policy on sodium intake may be appropriate, one that targets sodium reduction in populations consuming high sodium levels and reflects the uncertainty in those with moderate sodium diets, which includes the majority of the population."

This study was limited in that it involved patients who volunteered to participate in clinical trials, who may have different lifestyles and behaviors than those who declined to participate. Also, urinary samples were taken at a single time point, which may not accurately reflect subjects’ typical sodium and potassium excretion, Dr. O’Donnell and his associates said.

This study was supported by Boehringer Ingelheim, a manufacturer of angiotensin II receptor blockers. Dr. O’Donnell and several associates reported ties to Boehringer Ingelheim, and his associates reported ties to numerous other industry sources.

High urinary sodium excretion, a proxy for high sodium intake, was associated with an increased risk of cardiovascular mortality, myocardial infarction, stroke, and hospitalization for heart failure in a study in the Nov. 23/30 JAMA.

However, low urinary sodium excretion also was associated with increased risk of cardiovascular mortality and hospitalization for heart failure.

"Our findings emphasize the burden of CV disease associated with excess sodium intake and the importance of population-based programs to reduce sodium intake in populations consuming high-sodium diets," Dr. Martin J. O’Donnell of the Population Health Research Institute, McMaster University, Hamilton, Ont., and his associates.

© Georges Lievre / Fotolia.com

Importantly, the association between sodium intake and adverse CV outcomes did not become significant until intake exceeded 6.5 g/day. This threshold is higher than that recommended by the World Health Organization and by many national guidelines. This highlights "the urgent need to establish a safe range for sodium intake," they noted.

"We found a J-shaped association between estimated sodium excretion and CV events," the researchers noted.

Compared with the "moderate" sodium excretion of 4-5.99 g/day, both higher (more than 7 g/day) and lower (less than 3 g/day) sodium excretion were linked to adverse CV events.

They examined the relationship between sodium intake and CV events using data from two large clinical trials in which patients at high risk for CV events provided urinary samples and were followed for a median of 56 months. Data from the two trials were combined because both recruited subjects from the same areas during the same time period (2001-2004) using the same eligibility criteria and the same methods of obtaining baseline clinical data and monitoring outcomes.

A total of 28,880 study subjects followed at 733 medical centers in 40 countries were included. The subjects were aged 55 and older and either had established CV disease or high-risk diabetes.

Sodium and potassium concentrations were determined from a single morning fasting urine sample from each subject, and this was used to estimate 24-hour sodium and potassium excretion. Overall, the mean estimated 24-hour sodium excretion, a proxy for sodium intake, was 4.77 g, and potassium excretion, a proxy for potassium intake, was 2.19 g.

The composite outcome of CV death, MI, stroke, and hospitalization for heart failure occurred in 4,729 study subjects (16%) during follow-up through 2008. Overall mortality was 12%, the rate of MI was 5%, that of stroke and heart failure hospitalization were each about 4%.

Compared with the moderate excretion of 4-5.99 g/day, higher excretion (more than 7 g/day) was associated with a hazard ratio of 1.15-1.49 for the composite end point. And those with lower excretion (less than 3 g/day), had a hazard ratio of 1.16-1.21 for the composite end point.

In addition, high sodium excretion was significantly associated with each of the individual components of this composite outcome, Dr. O’Donnell and his colleagues said (JAMA 2011;306:2229-38).

"We found a J-shaped association between estimated sodium excretion and CV events."

Lower sodium excretion also was associated with increased risk of heart failure hospitalization.

These results remained robust in several sensitivity and subgroup analyses.

No association was found between potassium excretion and any of the CV outcomes, except that higher potassium excretion was related to a reduced risk of stroke.

"Clearly, large randomized controlled trials evaluating the effect of reduced sodium intake ... on CV outcomes in those with moderate sodium intake are needed urgently. Pending the results of such trials, a more cautious approach to policy on sodium intake may be appropriate, one that targets sodium reduction in populations consuming high sodium levels and reflects the uncertainty in those with moderate sodium diets, which includes the majority of the population."

This study was limited in that it involved patients who volunteered to participate in clinical trials, who may have different lifestyles and behaviors than those who declined to participate. Also, urinary samples were taken at a single time point, which may not accurately reflect subjects’ typical sodium and potassium excretion, Dr. O’Donnell and his associates said.

This study was supported by Boehringer Ingelheim, a manufacturer of angiotensin II receptor blockers. Dr. O’Donnell and several associates reported ties to Boehringer Ingelheim, and his associates reported ties to numerous other industry sources.

High urinary sodium excretion, a proxy for high sodium intake, was associated with an increased risk of cardiovascular mortality, myocardial infarction, stroke, and hospitalization for heart failure in a study in the Nov. 23/30 JAMA.

However, low urinary sodium excretion also was associated with increased risk of cardiovascular mortality and hospitalization for heart failure.

"Our findings emphasize the burden of CV disease associated with excess sodium intake and the importance of population-based programs to reduce sodium intake in populations consuming high-sodium diets," Dr. Martin J. O’Donnell of the Population Health Research Institute, McMaster University, Hamilton, Ont., and his associates.

© Georges Lievre / Fotolia.com

Importantly, the association between sodium intake and adverse CV outcomes did not become significant until intake exceeded 6.5 g/day. This threshold is higher than that recommended by the World Health Organization and by many national guidelines. This highlights "the urgent need to establish a safe range for sodium intake," they noted.

"We found a J-shaped association between estimated sodium excretion and CV events," the researchers noted.

Compared with the "moderate" sodium excretion of 4-5.99 g/day, both higher (more than 7 g/day) and lower (less than 3 g/day) sodium excretion were linked to adverse CV events.

They examined the relationship between sodium intake and CV events using data from two large clinical trials in which patients at high risk for CV events provided urinary samples and were followed for a median of 56 months. Data from the two trials were combined because both recruited subjects from the same areas during the same time period (2001-2004) using the same eligibility criteria and the same methods of obtaining baseline clinical data and monitoring outcomes.

A total of 28,880 study subjects followed at 733 medical centers in 40 countries were included. The subjects were aged 55 and older and either had established CV disease or high-risk diabetes.

Sodium and potassium concentrations were determined from a single morning fasting urine sample from each subject, and this was used to estimate 24-hour sodium and potassium excretion. Overall, the mean estimated 24-hour sodium excretion, a proxy for sodium intake, was 4.77 g, and potassium excretion, a proxy for potassium intake, was 2.19 g.

The composite outcome of CV death, MI, stroke, and hospitalization for heart failure occurred in 4,729 study subjects (16%) during follow-up through 2008. Overall mortality was 12%, the rate of MI was 5%, that of stroke and heart failure hospitalization were each about 4%.

Compared with the moderate excretion of 4-5.99 g/day, higher excretion (more than 7 g/day) was associated with a hazard ratio of 1.15-1.49 for the composite end point. And those with lower excretion (less than 3 g/day), had a hazard ratio of 1.16-1.21 for the composite end point.

In addition, high sodium excretion was significantly associated with each of the individual components of this composite outcome, Dr. O’Donnell and his colleagues said (JAMA 2011;306:2229-38).

"We found a J-shaped association between estimated sodium excretion and CV events."

Lower sodium excretion also was associated with increased risk of heart failure hospitalization.

These results remained robust in several sensitivity and subgroup analyses.

No association was found between potassium excretion and any of the CV outcomes, except that higher potassium excretion was related to a reduced risk of stroke.

"Clearly, large randomized controlled trials evaluating the effect of reduced sodium intake ... on CV outcomes in those with moderate sodium intake are needed urgently. Pending the results of such trials, a more cautious approach to policy on sodium intake may be appropriate, one that targets sodium reduction in populations consuming high sodium levels and reflects the uncertainty in those with moderate sodium diets, which includes the majority of the population."

This study was limited in that it involved patients who volunteered to participate in clinical trials, who may have different lifestyles and behaviors than those who declined to participate. Also, urinary samples were taken at a single time point, which may not accurately reflect subjects’ typical sodium and potassium excretion, Dr. O’Donnell and his associates said.

This study was supported by Boehringer Ingelheim, a manufacturer of angiotensin II receptor blockers. Dr. O’Donnell and several associates reported ties to Boehringer Ingelheim, and his associates reported ties to numerous other industry sources.

Taking oral antibiotics to treat acne tripled a patient’s risk of developing pharyngitis, according to a study published online Nov. 21 in Archives of Dermatology.

However, using topical antibiotics for acne had no such effect, said Dr. David J. Margolis of the department of dermatology and the department of epidemiology and biostatistics, University of Pennsylvania, Philadelphia, and his associates.

Previous retrospective cohort studies and cross-sectional studies have noted an association between acne therapy with oral antibiotics and pharyngitis, but no prospective study has examined the issue until now. Dr. Margolis and his colleagues conducted one cross-sectional study involving 266 patients seen on a single occasion and one prospective longitudinal study involving 579 different patients seen over the course of a school year.

In the cross-sectional study, male and female graduate and postgraduate students (mean age 21 years) reported whether they were currently using antibiotics for acne and whether they had pharyngitis, currently or within the preceding month, that was severe enough to warrant a visit to a health care provider.

Of the 15 students who said they were taking oral antibiotics for acne, 10 (66.7%) had current or recent pharyngitis, compared with 82 of the 251 students (32.7%) who were not taking oral antibiotics.

Thus, the rate of pharyngitis was more than twice as high among subjects taking oral antibiotics as among those who weren’t taking the drugs in the cross-sectional study.

In the prospective longitudinal study, male and female students (mean age also 21 years) reported during three survey periods whether they were taking antibiotics for acne and whether they had pharyngitis within the preceding month that was severe enough to warrant a visit to a health care provider.

A total of 11.3% of subjects taking oral antibiotics reported having pharyngitis, compared with 3.3% of subjects who weren’t taking oral antibiotics for acne.

Thus, in the prospective longitudinal study, the rate of pharyngitis was more than 3 times higher among subjects taking oral antibiotics than the rate among those who weren’t taking them, the investigators said (Arch. Dermatol. 2011 Nov. 21 [doi:10.1001/archdermatol.2011.355]).

In contrast, rates of pharyngitis were not significantly higher among subjects using topical antibiotics for acne than among those not using any antibiotics.

Before conducting the two studies, Dr. Margolis and his associates had postulated that the use of oral antibiotics may have changed the microbial flora in the throat – for example, increasing pharyngeal colonization with group A streptococcus, "with a resulting increase in the frequency of symptomatic infection."

They proposed that the drugs may have acted by reducing the presence of less virulent organisms known to prevent colonization with group A strep, such as Streptococcus salivarius.

Contrary to that hypothesis, however, there was no association between pharyngeal colonization with either of those organisms and oral antibiotic use in the two studies.

The studies were limited in that they relied on students’ self reports both of antibiotic use and health care visits for pharyngitis; the student health clinic would not reveal the contents of students’ medical histories because of privacy concerns. In addition, the two studies may have missed some confounding risk factor that could be associated with both pharyngitis and antibiotic use, such as smoking status, the researchers said.

The National Institutes of Health supported the two studies. No financial conflicts of interest were reported.

Taking oral antibiotics to treat acne tripled a patient’s risk of developing pharyngitis, according to a study published online Nov. 21 in Archives of Dermatology.

However, using topical antibiotics for acne had no such effect, said Dr. David J. Margolis of the department of dermatology and the department of epidemiology and biostatistics, University of Pennsylvania, Philadelphia, and his associates.

Previous retrospective cohort studies and cross-sectional studies have noted an association between acne therapy with oral antibiotics and pharyngitis, but no prospective study has examined the issue until now. Dr. Margolis and his colleagues conducted one cross-sectional study involving 266 patients seen on a single occasion and one prospective longitudinal study involving 579 different patients seen over the course of a school year.

In the cross-sectional study, male and female graduate and postgraduate students (mean age 21 years) reported whether they were currently using antibiotics for acne and whether they had pharyngitis, currently or within the preceding month, that was severe enough to warrant a visit to a health care provider.

Of the 15 students who said they were taking oral antibiotics for acne, 10 (66.7%) had current or recent pharyngitis, compared with 82 of the 251 students (32.7%) who were not taking oral antibiotics.

Thus, the rate of pharyngitis was more than twice as high among subjects taking oral antibiotics as among those who weren’t taking the drugs in the cross-sectional study.

In the prospective longitudinal study, male and female students (mean age also 21 years) reported during three survey periods whether they were taking antibiotics for acne and whether they had pharyngitis within the preceding month that was severe enough to warrant a visit to a health care provider.

A total of 11.3% of subjects taking oral antibiotics reported having pharyngitis, compared with 3.3% of subjects who weren’t taking oral antibiotics for acne.

Thus, in the prospective longitudinal study, the rate of pharyngitis was more than 3 times higher among subjects taking oral antibiotics than the rate among those who weren’t taking them, the investigators said (Arch. Dermatol. 2011 Nov. 21 [doi:10.1001/archdermatol.2011.355]).

In contrast, rates of pharyngitis were not significantly higher among subjects using topical antibiotics for acne than among those not using any antibiotics.

Before conducting the two studies, Dr. Margolis and his associates had postulated that the use of oral antibiotics may have changed the microbial flora in the throat – for example, increasing pharyngeal colonization with group A streptococcus, "with a resulting increase in the frequency of symptomatic infection."

They proposed that the drugs may have acted by reducing the presence of less virulent organisms known to prevent colonization with group A strep, such as Streptococcus salivarius.

Contrary to that hypothesis, however, there was no association between pharyngeal colonization with either of those organisms and oral antibiotic use in the two studies.

The studies were limited in that they relied on students’ self reports both of antibiotic use and health care visits for pharyngitis; the student health clinic would not reveal the contents of students’ medical histories because of privacy concerns. In addition, the two studies may have missed some confounding risk factor that could be associated with both pharyngitis and antibiotic use, such as smoking status, the researchers said.

The National Institutes of Health supported the two studies. No financial conflicts of interest were reported.

Taking oral antibiotics to treat acne tripled a patient’s risk of developing pharyngitis, according to a study published online Nov. 21 in Archives of Dermatology.

However, using topical antibiotics for acne had no such effect, said Dr. David J. Margolis of the department of dermatology and the department of epidemiology and biostatistics, University of Pennsylvania, Philadelphia, and his associates.

Previous retrospective cohort studies and cross-sectional studies have noted an association between acne therapy with oral antibiotics and pharyngitis, but no prospective study has examined the issue until now. Dr. Margolis and his colleagues conducted one cross-sectional study involving 266 patients seen on a single occasion and one prospective longitudinal study involving 579 different patients seen over the course of a school year.

In the cross-sectional study, male and female graduate and postgraduate students (mean age 21 years) reported whether they were currently using antibiotics for acne and whether they had pharyngitis, currently or within the preceding month, that was severe enough to warrant a visit to a health care provider.

Of the 15 students who said they were taking oral antibiotics for acne, 10 (66.7%) had current or recent pharyngitis, compared with 82 of the 251 students (32.7%) who were not taking oral antibiotics.

Thus, the rate of pharyngitis was more than twice as high among subjects taking oral antibiotics as among those who weren’t taking the drugs in the cross-sectional study.

In the prospective longitudinal study, male and female students (mean age also 21 years) reported during three survey periods whether they were taking antibiotics for acne and whether they had pharyngitis within the preceding month that was severe enough to warrant a visit to a health care provider.

A total of 11.3% of subjects taking oral antibiotics reported having pharyngitis, compared with 3.3% of subjects who weren’t taking oral antibiotics for acne.

Thus, in the prospective longitudinal study, the rate of pharyngitis was more than 3 times higher among subjects taking oral antibiotics than the rate among those who weren’t taking them, the investigators said (Arch. Dermatol. 2011 Nov. 21 [doi:10.1001/archdermatol.2011.355]).

In contrast, rates of pharyngitis were not significantly higher among subjects using topical antibiotics for acne than among those not using any antibiotics.

Before conducting the two studies, Dr. Margolis and his associates had postulated that the use of oral antibiotics may have changed the microbial flora in the throat – for example, increasing pharyngeal colonization with group A streptococcus, "with a resulting increase in the frequency of symptomatic infection."

They proposed that the drugs may have acted by reducing the presence of less virulent organisms known to prevent colonization with group A strep, such as Streptococcus salivarius.

Contrary to that hypothesis, however, there was no association between pharyngeal colonization with either of those organisms and oral antibiotic use in the two studies.

The studies were limited in that they relied on students’ self reports both of antibiotic use and health care visits for pharyngitis; the student health clinic would not reveal the contents of students’ medical histories because of privacy concerns. In addition, the two studies may have missed some confounding risk factor that could be associated with both pharyngitis and antibiotic use, such as smoking status, the researchers said.

The National Institutes of Health supported the two studies. No financial conflicts of interest were reported.