Diana Mahoney

Major Finding: Nondiabetic persons who were positive for all three of the risk criteria of a simplified prediction had a nearly 20% risk of developing type 2 diabetes over a 5-year follow-up period.

Data Source: A longitudinal analysis of data from a 5-year, population-based survey conducted among a representative sample of 22,001 persons aged 18 years or older with no diabetes at baseline.

Disclosures: Dr. Bays disclosed that he has served as an adviser to AstraZeneca.

ORLANDO – A simple, three-item measure can accurately identify individuals who are at high risk for developing type 2 diabetes in the subsequent 5 years, Dr. Harold E. Bays said at the meeting.

In an analysis of the data from a longitudinal, population-based survey, respondents who were 55 years or older and had a body mass index greater than 30 kg/m

Other measures are available to assess the risk of developing type 2 diabetes; however, “most of the tests and models use seven or more risk predictors, which is cumbersome for individuals to use in estimating their risk and may diminish their motivation for seeking medical care,” Dr. Bays suggested.

“With these three predictors – age, BMI, and family history – patients and physicians may be able to better identify undiagnosed diabetes and initiate preventive measures,” he said.

To evaluate the feasibility of a simplified risk-prediction tool, the investigators used data from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), which included the results of annual surveys from 2005 to 2009 that were completed by 22,001 respondents screened from a representative sample of the U.S. population, Dr. Bays explained. Respondents aged at least 18 years were included in the current longitudinal analysis if they reported no diagnosis of type 2, type 1, or gestational diabetes at baseline, and if they reported their BMI, age, and family history of diabetes at baseline and 5 years later, he said.

Obesity was defined as a BMI of at least 30, and normal weight was defined as a BMI of less than 25. Individuals aged at least 55 years with self-reported obesity and a family history of diabetes were included in a high-risk group, “which we compared with a low-risk group consisting of respondents younger than 55 years, who reported normal weight and no family history of diabetes,” said Dr. Bays.

To compare the 290 individuals in the high-risk group with the 408 in the low-risk group, “we used chi-square test for categorical variables and t-tests for continuous variables,” he said.

An assessment of the baseline characteristics showed that a greater proportion of the high-risk respondents reported a low household income, a smaller household size, fair or poor health status, asthma, and circulatory problems, compared with the low-risk group, Dr. Bays said.

With respect to the disease risk factors, “the results of our analysis showed that nearly 20% of the individuals in the high-risk group received a new diagnosis of type 2 diabetes over the 5 year study period, while those in the low-risk group had an almost negligible 5-year risk, at 0.03%,” he said.

The study findings are limited by the fact that the patients' diagnoses of diabetes and other comorbid conditions were self-reported and not validated, Dr. Bays noted.

The investigators' simplified prediction model is not intended to replace more comprehensive tools, such as the Diabetes Risk Test recommended by the American Diabetes Association for individual risk self-assessment, he stressed at the meeting.

“Our study was not designed to compare the efficacy of the simplified and full tools,” he said. For that matter, he added, “whether one or the other is superior is irrelevant if clinicians are not currently doing any diabetes risk assessment.” Clinicians who are already using the full algorithm should probably continue to do so, he said, noting that the simpler option might be incentive for those not currently using anything to jump on board.

'Whether one [tool] or the other is superior is irrelevant if clinicians are not' doing any risk assessment.

Source DR. BAYS

Major Finding: Nondiabetic persons who were positive for all three of the risk criteria of a simplified prediction had a nearly 20% risk of developing type 2 diabetes over a 5-year follow-up period.

Data Source: A longitudinal analysis of data from a 5-year, population-based survey conducted among a representative sample of 22,001 persons aged 18 years or older with no diabetes at baseline.

Disclosures: Dr. Bays disclosed that he has served as an adviser to AstraZeneca.

ORLANDO – A simple, three-item measure can accurately identify individuals who are at high risk for developing type 2 diabetes in the subsequent 5 years, Dr. Harold E. Bays said at the meeting.

In an analysis of the data from a longitudinal, population-based survey, respondents who were 55 years or older and had a body mass index greater than 30 kg/m

Other measures are available to assess the risk of developing type 2 diabetes; however, “most of the tests and models use seven or more risk predictors, which is cumbersome for individuals to use in estimating their risk and may diminish their motivation for seeking medical care,” Dr. Bays suggested.

“With these three predictors – age, BMI, and family history – patients and physicians may be able to better identify undiagnosed diabetes and initiate preventive measures,” he said.

To evaluate the feasibility of a simplified risk-prediction tool, the investigators used data from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), which included the results of annual surveys from 2005 to 2009 that were completed by 22,001 respondents screened from a representative sample of the U.S. population, Dr. Bays explained. Respondents aged at least 18 years were included in the current longitudinal analysis if they reported no diagnosis of type 2, type 1, or gestational diabetes at baseline, and if they reported their BMI, age, and family history of diabetes at baseline and 5 years later, he said.

Obesity was defined as a BMI of at least 30, and normal weight was defined as a BMI of less than 25. Individuals aged at least 55 years with self-reported obesity and a family history of diabetes were included in a high-risk group, “which we compared with a low-risk group consisting of respondents younger than 55 years, who reported normal weight and no family history of diabetes,” said Dr. Bays.

To compare the 290 individuals in the high-risk group with the 408 in the low-risk group, “we used chi-square test for categorical variables and t-tests for continuous variables,” he said.

An assessment of the baseline characteristics showed that a greater proportion of the high-risk respondents reported a low household income, a smaller household size, fair or poor health status, asthma, and circulatory problems, compared with the low-risk group, Dr. Bays said.

With respect to the disease risk factors, “the results of our analysis showed that nearly 20% of the individuals in the high-risk group received a new diagnosis of type 2 diabetes over the 5 year study period, while those in the low-risk group had an almost negligible 5-year risk, at 0.03%,” he said.

The study findings are limited by the fact that the patients' diagnoses of diabetes and other comorbid conditions were self-reported and not validated, Dr. Bays noted.

The investigators' simplified prediction model is not intended to replace more comprehensive tools, such as the Diabetes Risk Test recommended by the American Diabetes Association for individual risk self-assessment, he stressed at the meeting.

“Our study was not designed to compare the efficacy of the simplified and full tools,” he said. For that matter, he added, “whether one or the other is superior is irrelevant if clinicians are not currently doing any diabetes risk assessment.” Clinicians who are already using the full algorithm should probably continue to do so, he said, noting that the simpler option might be incentive for those not currently using anything to jump on board.

'Whether one [tool] or the other is superior is irrelevant if clinicians are not' doing any risk assessment.

Source DR. BAYS

Major Finding: Nondiabetic persons who were positive for all three of the risk criteria of a simplified prediction had a nearly 20% risk of developing type 2 diabetes over a 5-year follow-up period.

Data Source: A longitudinal analysis of data from a 5-year, population-based survey conducted among a representative sample of 22,001 persons aged 18 years or older with no diabetes at baseline.

Disclosures: Dr. Bays disclosed that he has served as an adviser to AstraZeneca.

ORLANDO – A simple, three-item measure can accurately identify individuals who are at high risk for developing type 2 diabetes in the subsequent 5 years, Dr. Harold E. Bays said at the meeting.

In an analysis of the data from a longitudinal, population-based survey, respondents who were 55 years or older and had a body mass index greater than 30 kg/m

Other measures are available to assess the risk of developing type 2 diabetes; however, “most of the tests and models use seven or more risk predictors, which is cumbersome for individuals to use in estimating their risk and may diminish their motivation for seeking medical care,” Dr. Bays suggested.

“With these three predictors – age, BMI, and family history – patients and physicians may be able to better identify undiagnosed diabetes and initiate preventive measures,” he said.

To evaluate the feasibility of a simplified risk-prediction tool, the investigators used data from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), which included the results of annual surveys from 2005 to 2009 that were completed by 22,001 respondents screened from a representative sample of the U.S. population, Dr. Bays explained. Respondents aged at least 18 years were included in the current longitudinal analysis if they reported no diagnosis of type 2, type 1, or gestational diabetes at baseline, and if they reported their BMI, age, and family history of diabetes at baseline and 5 years later, he said.

Obesity was defined as a BMI of at least 30, and normal weight was defined as a BMI of less than 25. Individuals aged at least 55 years with self-reported obesity and a family history of diabetes were included in a high-risk group, “which we compared with a low-risk group consisting of respondents younger than 55 years, who reported normal weight and no family history of diabetes,” said Dr. Bays.

To compare the 290 individuals in the high-risk group with the 408 in the low-risk group, “we used chi-square test for categorical variables and t-tests for continuous variables,” he said.

An assessment of the baseline characteristics showed that a greater proportion of the high-risk respondents reported a low household income, a smaller household size, fair or poor health status, asthma, and circulatory problems, compared with the low-risk group, Dr. Bays said.

With respect to the disease risk factors, “the results of our analysis showed that nearly 20% of the individuals in the high-risk group received a new diagnosis of type 2 diabetes over the 5 year study period, while those in the low-risk group had an almost negligible 5-year risk, at 0.03%,” he said.

The study findings are limited by the fact that the patients' diagnoses of diabetes and other comorbid conditions were self-reported and not validated, Dr. Bays noted.

The investigators' simplified prediction model is not intended to replace more comprehensive tools, such as the Diabetes Risk Test recommended by the American Diabetes Association for individual risk self-assessment, he stressed at the meeting.

“Our study was not designed to compare the efficacy of the simplified and full tools,” he said. For that matter, he added, “whether one or the other is superior is irrelevant if clinicians are not currently doing any diabetes risk assessment.” Clinicians who are already using the full algorithm should probably continue to do so, he said, noting that the simpler option might be incentive for those not currently using anything to jump on board.

'Whether one [tool] or the other is superior is irrelevant if clinicians are not' doing any risk assessment.

Source DR. BAYS

BOSTON – Mandatory assessment protocols for outpatient parenteral antimicrobial therapy appear to be scoring successes in patient selection, based on a single-center, retrospective review of cases deemed inappropriate for the treatment approach.

Appropriate denial of outpatient parenteral antimicrobial therapy (OPAT) and peripherally inserted central catheter (PICC) placement by infectious disease physicians appears to avoid unnecessary antibiotic usage, PICC-line complications, and costs without compromising successful clinical outcomes, Dr. Marjorie Conant said at the annual meeting of the Infectious Diseases Society of America (IDSA).

OPAT is being used more widely because of its potential to reduce morbidity, to allow earlier discharges, to improve quality of life, and to reduce treatment costs. But to be successful, OPAT needs to be directed at stable patients who need long-term antibiotic therapy. To assist in patient selection, IDSA practice guidelines recommend that infectious disease physicians take part in evaluating candidates for OPAT (Clin. Infect. Dis. 2004;38:1651-72), and many hospitals have implemented mandatory assessment protocols.

To date, however, "no published studies have looked at the clinical outcomes of patients who were not approved [for OPAT] or at the economic impact of averted [OPAT]," said Dr. Conant of Indiana University, Indianapolis, who performed such an analysis with coinvestigators at Wishard Health Services and Purdue University, also in Indianapolis.

The researchers reviewed the electronic medical records of patients who were considered for OPAT but were denied by the inpatient infectious disease consult service at Wishard, an inner-city, county teaching hospital. The evaluations took place from 2008 to 2010; children, pregnant women, and incarcerated individuals were not included in the study.

"No published studies have looked at the clinical outcomes of patients who were not approved [for OPAT] or at the economic impact of averted [OPAT]."

Demographic and medical data, including infection- and medication-specific information, were evaluated for each patient. Clinical outcome data at one year following the OPAT denial was used to classify cure rates. "Definitively cured" was defined as a documented clinical or microbiologic cure without recurrence of the infection for up to 1 year. "Probably cured" was presumed eradication of infection and no EMR-documented return visits for continued or worsening infection for up to 1 year. "Treatment failures" were those who experienced worsening or recurrence of the same infection.

The number of patients who experienced each of the clinical outcomes and the total number of patients in whom OPAT was averted were used to determine the overall rate of cure, probable cure, and treatment failure.

Of the 57 patients who met the study’s inclusion criteria, 32 (56%) were categorized as definitive cures, 9 (16%) were probable cures, and 16 (28%) were treatment failures, Dr. Conant reported. The cures and failures had similar rates of obesity, diabetes, and smoking. "Only age was found to be significantly different between patients who experienced clinical cure and clinical failure." Those in the cure group averaged 57 years of age; those in the failure group averaged 46 years.

Of the 16 treatment failures, "only four patients were thought to be true failures," Dr. Conant said. The remaining 12 patients either did not comply with the prescribed oral antibiotic therapy or their underlying disease processes progressed.

Thus, "4 of 57 patients in whom [OPAT] was denied by the infectious disease service experienced a true clinical failure," she said.

OPAT requires placement of a PICC line by an outside contractor, along with confirmatory chest x-ray, at a cost of approximately $1,000/patient, Dr. Conant said. Thus, the preliminary cost analysis suggests that the appropriate denial of 53 PICC lines saved the hospital approximately $53,000.

Further cost analyses are currently underway, she said, noting that when the costs of labs, antibiotics, supplies, and personnel associated with OPAT are included, "the cost savings will increase exponentially," as will the nonmonetary savings, such as reductions in mechanical PICC complications, line infections, Clostridium difficile colitis, and antibiotic resistance.

The study findings are limited by the lack of prospective monitoring of patients who were denied OPAT and the possibility that "probable cure" patients may have sought and received treatment for worsening infections that were not detected through the EMR review, Dr. Conant said.

Dr. Conant had no relevant financial conflicts to disclose.

BOSTON – Mandatory assessment protocols for outpatient parenteral antimicrobial therapy appear to be scoring successes in patient selection, based on a single-center, retrospective review of cases deemed inappropriate for the treatment approach.

Appropriate denial of outpatient parenteral antimicrobial therapy (OPAT) and peripherally inserted central catheter (PICC) placement by infectious disease physicians appears to avoid unnecessary antibiotic usage, PICC-line complications, and costs without compromising successful clinical outcomes, Dr. Marjorie Conant said at the annual meeting of the Infectious Diseases Society of America (IDSA).

OPAT is being used more widely because of its potential to reduce morbidity, to allow earlier discharges, to improve quality of life, and to reduce treatment costs. But to be successful, OPAT needs to be directed at stable patients who need long-term antibiotic therapy. To assist in patient selection, IDSA practice guidelines recommend that infectious disease physicians take part in evaluating candidates for OPAT (Clin. Infect. Dis. 2004;38:1651-72), and many hospitals have implemented mandatory assessment protocols.

To date, however, "no published studies have looked at the clinical outcomes of patients who were not approved [for OPAT] or at the economic impact of averted [OPAT]," said Dr. Conant of Indiana University, Indianapolis, who performed such an analysis with coinvestigators at Wishard Health Services and Purdue University, also in Indianapolis.

The researchers reviewed the electronic medical records of patients who were considered for OPAT but were denied by the inpatient infectious disease consult service at Wishard, an inner-city, county teaching hospital. The evaluations took place from 2008 to 2010; children, pregnant women, and incarcerated individuals were not included in the study.

"No published studies have looked at the clinical outcomes of patients who were not approved [for OPAT] or at the economic impact of averted [OPAT]."

Demographic and medical data, including infection- and medication-specific information, were evaluated for each patient. Clinical outcome data at one year following the OPAT denial was used to classify cure rates. "Definitively cured" was defined as a documented clinical or microbiologic cure without recurrence of the infection for up to 1 year. "Probably cured" was presumed eradication of infection and no EMR-documented return visits for continued or worsening infection for up to 1 year. "Treatment failures" were those who experienced worsening or recurrence of the same infection.

The number of patients who experienced each of the clinical outcomes and the total number of patients in whom OPAT was averted were used to determine the overall rate of cure, probable cure, and treatment failure.

Of the 57 patients who met the study’s inclusion criteria, 32 (56%) were categorized as definitive cures, 9 (16%) were probable cures, and 16 (28%) were treatment failures, Dr. Conant reported. The cures and failures had similar rates of obesity, diabetes, and smoking. "Only age was found to be significantly different between patients who experienced clinical cure and clinical failure." Those in the cure group averaged 57 years of age; those in the failure group averaged 46 years.

Of the 16 treatment failures, "only four patients were thought to be true failures," Dr. Conant said. The remaining 12 patients either did not comply with the prescribed oral antibiotic therapy or their underlying disease processes progressed.

Thus, "4 of 57 patients in whom [OPAT] was denied by the infectious disease service experienced a true clinical failure," she said.

OPAT requires placement of a PICC line by an outside contractor, along with confirmatory chest x-ray, at a cost of approximately $1,000/patient, Dr. Conant said. Thus, the preliminary cost analysis suggests that the appropriate denial of 53 PICC lines saved the hospital approximately $53,000.

Further cost analyses are currently underway, she said, noting that when the costs of labs, antibiotics, supplies, and personnel associated with OPAT are included, "the cost savings will increase exponentially," as will the nonmonetary savings, such as reductions in mechanical PICC complications, line infections, Clostridium difficile colitis, and antibiotic resistance.

The study findings are limited by the lack of prospective monitoring of patients who were denied OPAT and the possibility that "probable cure" patients may have sought and received treatment for worsening infections that were not detected through the EMR review, Dr. Conant said.

Dr. Conant had no relevant financial conflicts to disclose.

BOSTON – Mandatory assessment protocols for outpatient parenteral antimicrobial therapy appear to be scoring successes in patient selection, based on a single-center, retrospective review of cases deemed inappropriate for the treatment approach.

Appropriate denial of outpatient parenteral antimicrobial therapy (OPAT) and peripherally inserted central catheter (PICC) placement by infectious disease physicians appears to avoid unnecessary antibiotic usage, PICC-line complications, and costs without compromising successful clinical outcomes, Dr. Marjorie Conant said at the annual meeting of the Infectious Diseases Society of America (IDSA).

OPAT is being used more widely because of its potential to reduce morbidity, to allow earlier discharges, to improve quality of life, and to reduce treatment costs. But to be successful, OPAT needs to be directed at stable patients who need long-term antibiotic therapy. To assist in patient selection, IDSA practice guidelines recommend that infectious disease physicians take part in evaluating candidates for OPAT (Clin. Infect. Dis. 2004;38:1651-72), and many hospitals have implemented mandatory assessment protocols.

To date, however, "no published studies have looked at the clinical outcomes of patients who were not approved [for OPAT] or at the economic impact of averted [OPAT]," said Dr. Conant of Indiana University, Indianapolis, who performed such an analysis with coinvestigators at Wishard Health Services and Purdue University, also in Indianapolis.

The researchers reviewed the electronic medical records of patients who were considered for OPAT but were denied by the inpatient infectious disease consult service at Wishard, an inner-city, county teaching hospital. The evaluations took place from 2008 to 2010; children, pregnant women, and incarcerated individuals were not included in the study.

"No published studies have looked at the clinical outcomes of patients who were not approved [for OPAT] or at the economic impact of averted [OPAT]."

Demographic and medical data, including infection- and medication-specific information, were evaluated for each patient. Clinical outcome data at one year following the OPAT denial was used to classify cure rates. "Definitively cured" was defined as a documented clinical or microbiologic cure without recurrence of the infection for up to 1 year. "Probably cured" was presumed eradication of infection and no EMR-documented return visits for continued or worsening infection for up to 1 year. "Treatment failures" were those who experienced worsening or recurrence of the same infection.

The number of patients who experienced each of the clinical outcomes and the total number of patients in whom OPAT was averted were used to determine the overall rate of cure, probable cure, and treatment failure.

Of the 57 patients who met the study’s inclusion criteria, 32 (56%) were categorized as definitive cures, 9 (16%) were probable cures, and 16 (28%) were treatment failures, Dr. Conant reported. The cures and failures had similar rates of obesity, diabetes, and smoking. "Only age was found to be significantly different between patients who experienced clinical cure and clinical failure." Those in the cure group averaged 57 years of age; those in the failure group averaged 46 years.

Of the 16 treatment failures, "only four patients were thought to be true failures," Dr. Conant said. The remaining 12 patients either did not comply with the prescribed oral antibiotic therapy or their underlying disease processes progressed.

Thus, "4 of 57 patients in whom [OPAT] was denied by the infectious disease service experienced a true clinical failure," she said.

OPAT requires placement of a PICC line by an outside contractor, along with confirmatory chest x-ray, at a cost of approximately $1,000/patient, Dr. Conant said. Thus, the preliminary cost analysis suggests that the appropriate denial of 53 PICC lines saved the hospital approximately $53,000.

Further cost analyses are currently underway, she said, noting that when the costs of labs, antibiotics, supplies, and personnel associated with OPAT are included, "the cost savings will increase exponentially," as will the nonmonetary savings, such as reductions in mechanical PICC complications, line infections, Clostridium difficile colitis, and antibiotic resistance.

The study findings are limited by the lack of prospective monitoring of patients who were denied OPAT and the possibility that "probable cure" patients may have sought and received treatment for worsening infections that were not detected through the EMR review, Dr. Conant said.

Dr. Conant had no relevant financial conflicts to disclose.

ORLANDO – A simple, three-item measure can accurately identify individuals who are at high risk for developing type 2 diabetes in the subsequent 5 years, Dr. Harold E. Bays said at the annual meeting of the Obesity Society.

In an analysis of data from a longitudinal, population-based survey, respondents who were 55 years or older with a body mass index greater than 30 kg/m² and a family history of diabetes had a 20% risk of developing diabetes during the 5-year follow-up period, while the risk for younger respondents with a BMI of less than 25 and no family history of diabetes was 0.3%, reported Dr. Bays of the Louisville (Ky.) Metabolic and Atherosclerosis Research Center.

Other measures are available to assess the risk of developing type 2 diabetes; however, "most of the tests and models use seven or more risk predictors, which is cumbersome for individuals to use in estimating their risk and may diminish their motivation for seeking medical care," Dr. Bays suggested. "With these three predictors – age, BMI, and family history – patients and physicians may be able to better identify undiagnosed diabetes and initiate preventive measures," he said.

To evaluate the feasibility of a simplified risk-prediction tool, the investigators used data from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), which included the results of annual surveys from 2005 to 2009 that were completed by 22,001 respondents screened from a representative sample of the U.S. population, Dr. Bays explained. Respondents aged at least 18 years were included in the current longitudinal analysis if they reported no diagnosis of type 2, type 1, or gestational diabetes at baseline, and if they reported their BMI, age, and family history of diabetes at baseline and 5 years later, he said.

Obesity was defined as a BMI of at least 30, and normal weight was defined as a BMI of less than 25. Individuals aged at least 55 years with self-reported obesity and a family history of diabetes were included in a high-risk group, "which we compared with a low-risk group consisting of respondents younger than 55 years, who reported normal weight and no family history of diabetes," said Dr. Bays. To compare the 290 individuals in the high-risk group with the 408 in the low-risk group, "we used chi-square test for categorical variables and t-tests for continuous variables," he said.

An assessment of the baseline characteristics showed that a greater proportion of the high-risk respondents reported a low household income, a smaller household size, fair or poor health status, asthma, and circulatory problems, compared with the low-risk group, Dr. Bays said. With respect to the disease risk factors, "the results of our analysis showed that nearly 20% of the individuals in the high-risk group received a new diagnosis of type 2 diabetes over the 5 year study period, while those in the low-risk group had an almost negligible 5-year risk, at 0.03%," he said.

The study findings are limited by the fact that diagnoses of diabetes and other comorbid conditions were self-reported and not validated, Dr. Bays noted.

The simplified prediction model is not intended to replace more comprehensive tools, such as the Diabetes Risk Test recommended by the American Diabetes Association for individual risk self-assessment, Dr. Bays stressed. "Our study was not designed to compare the efficacy of the simplified and full tools," he said.

For that matter, he added, "whether one or the other is superior is irrelevant if clinicians are not currently doing any diabetes risk assessment." Clinicians who are already using the full algorithm should probably continue to do so, he said, noting that the simpler option might be incentive for those not currently using anything to jump on board.

Dr. Bays disclosed that he has served as an adviser to AstraZeneca.

ORLANDO – A simple, three-item measure can accurately identify individuals who are at high risk for developing type 2 diabetes in the subsequent 5 years, Dr. Harold E. Bays said at the annual meeting of the Obesity Society.

In an analysis of data from a longitudinal, population-based survey, respondents who were 55 years or older with a body mass index greater than 30 kg/m² and a family history of diabetes had a 20% risk of developing diabetes during the 5-year follow-up period, while the risk for younger respondents with a BMI of less than 25 and no family history of diabetes was 0.3%, reported Dr. Bays of the Louisville (Ky.) Metabolic and Atherosclerosis Research Center.

Other measures are available to assess the risk of developing type 2 diabetes; however, "most of the tests and models use seven or more risk predictors, which is cumbersome for individuals to use in estimating their risk and may diminish their motivation for seeking medical care," Dr. Bays suggested. "With these three predictors – age, BMI, and family history – patients and physicians may be able to better identify undiagnosed diabetes and initiate preventive measures," he said.

To evaluate the feasibility of a simplified risk-prediction tool, the investigators used data from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), which included the results of annual surveys from 2005 to 2009 that were completed by 22,001 respondents screened from a representative sample of the U.S. population, Dr. Bays explained. Respondents aged at least 18 years were included in the current longitudinal analysis if they reported no diagnosis of type 2, type 1, or gestational diabetes at baseline, and if they reported their BMI, age, and family history of diabetes at baseline and 5 years later, he said.

Obesity was defined as a BMI of at least 30, and normal weight was defined as a BMI of less than 25. Individuals aged at least 55 years with self-reported obesity and a family history of diabetes were included in a high-risk group, "which we compared with a low-risk group consisting of respondents younger than 55 years, who reported normal weight and no family history of diabetes," said Dr. Bays. To compare the 290 individuals in the high-risk group with the 408 in the low-risk group, "we used chi-square test for categorical variables and t-tests for continuous variables," he said.

An assessment of the baseline characteristics showed that a greater proportion of the high-risk respondents reported a low household income, a smaller household size, fair or poor health status, asthma, and circulatory problems, compared with the low-risk group, Dr. Bays said. With respect to the disease risk factors, "the results of our analysis showed that nearly 20% of the individuals in the high-risk group received a new diagnosis of type 2 diabetes over the 5 year study period, while those in the low-risk group had an almost negligible 5-year risk, at 0.03%," he said.

The study findings are limited by the fact that diagnoses of diabetes and other comorbid conditions were self-reported and not validated, Dr. Bays noted.

The simplified prediction model is not intended to replace more comprehensive tools, such as the Diabetes Risk Test recommended by the American Diabetes Association for individual risk self-assessment, Dr. Bays stressed. "Our study was not designed to compare the efficacy of the simplified and full tools," he said.

For that matter, he added, "whether one or the other is superior is irrelevant if clinicians are not currently doing any diabetes risk assessment." Clinicians who are already using the full algorithm should probably continue to do so, he said, noting that the simpler option might be incentive for those not currently using anything to jump on board.

Dr. Bays disclosed that he has served as an adviser to AstraZeneca.

ORLANDO – A simple, three-item measure can accurately identify individuals who are at high risk for developing type 2 diabetes in the subsequent 5 years, Dr. Harold E. Bays said at the annual meeting of the Obesity Society.

In an analysis of data from a longitudinal, population-based survey, respondents who were 55 years or older with a body mass index greater than 30 kg/m² and a family history of diabetes had a 20% risk of developing diabetes during the 5-year follow-up period, while the risk for younger respondents with a BMI of less than 25 and no family history of diabetes was 0.3%, reported Dr. Bays of the Louisville (Ky.) Metabolic and Atherosclerosis Research Center.

Other measures are available to assess the risk of developing type 2 diabetes; however, "most of the tests and models use seven or more risk predictors, which is cumbersome for individuals to use in estimating their risk and may diminish their motivation for seeking medical care," Dr. Bays suggested. "With these three predictors – age, BMI, and family history – patients and physicians may be able to better identify undiagnosed diabetes and initiate preventive measures," he said.

To evaluate the feasibility of a simplified risk-prediction tool, the investigators used data from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), which included the results of annual surveys from 2005 to 2009 that were completed by 22,001 respondents screened from a representative sample of the U.S. population, Dr. Bays explained. Respondents aged at least 18 years were included in the current longitudinal analysis if they reported no diagnosis of type 2, type 1, or gestational diabetes at baseline, and if they reported their BMI, age, and family history of diabetes at baseline and 5 years later, he said.

Obesity was defined as a BMI of at least 30, and normal weight was defined as a BMI of less than 25. Individuals aged at least 55 years with self-reported obesity and a family history of diabetes were included in a high-risk group, "which we compared with a low-risk group consisting of respondents younger than 55 years, who reported normal weight and no family history of diabetes," said Dr. Bays. To compare the 290 individuals in the high-risk group with the 408 in the low-risk group, "we used chi-square test for categorical variables and t-tests for continuous variables," he said.

An assessment of the baseline characteristics showed that a greater proportion of the high-risk respondents reported a low household income, a smaller household size, fair or poor health status, asthma, and circulatory problems, compared with the low-risk group, Dr. Bays said. With respect to the disease risk factors, "the results of our analysis showed that nearly 20% of the individuals in the high-risk group received a new diagnosis of type 2 diabetes over the 5 year study period, while those in the low-risk group had an almost negligible 5-year risk, at 0.03%," he said.

The study findings are limited by the fact that diagnoses of diabetes and other comorbid conditions were self-reported and not validated, Dr. Bays noted.

The simplified prediction model is not intended to replace more comprehensive tools, such as the Diabetes Risk Test recommended by the American Diabetes Association for individual risk self-assessment, Dr. Bays stressed. "Our study was not designed to compare the efficacy of the simplified and full tools," he said.

For that matter, he added, "whether one or the other is superior is irrelevant if clinicians are not currently doing any diabetes risk assessment." Clinicians who are already using the full algorithm should probably continue to do so, he said, noting that the simpler option might be incentive for those not currently using anything to jump on board.

Dr. Bays disclosed that he has served as an adviser to AstraZeneca.

BOSTON – Initial antibiotic therapy failed in nearly 25% of 3,535 adults with acute bacterial skin and skin structure infections in U.S. hospitals between 2000 and 2009, according to a retrospective analysis of data from multiple hospitals.

Initial treatment failure was associated with significantly higher mortality, longer hospital stays, and higher costs of care, Xing-Yue Huang, Ph.D., reported at the annual meeting of the Infectious Diseases Society of America. The case-fatality rate was 1.3% in the 532 patients in the early treatment failure subgroup and 0.2% in the 3,003 successful treatment patients, a significant difference. The mean length of stay and total hospital charges were also significantly increased, at 8.1 days vs. 4.6 days and at $23,383 vs. $12,393, respectively.

The costs and benefits of initial treatment with broad-spectrum and narrower-spectrum regimens needs to be evaluated, Dr. Huang said. "Broad spectrum regimens are generally most effective but their benefits have to be measured against their higher cost. Narrower-spectrum regimens are less expensive but they may pose a higher risk of treatment failure."

Dr. Huang and colleagues used a database to identify all adult patients hospitalized for acute bacterial skin and skin structure infections (ABSSSI), such as abscess, cellulitis, and surgical site infection, between Jan. 1, 2000 and June 30, 2009. All patients in the analysis had at least one positive isolate from skin, wound, or blood cultures within 24 hours of initial clinical presentation. All received parenteral antibiotics for at least 48 hours beginning within 24 hours of hospital admission.

"More than half of the patients received initial regimens – usually multi-drug – that provided coverage for MRSA."

All antibiotics received within 24 hours of admission were considered initial therapy, said Dr. Huang of Forest Research Institute in Jersey City, N.J. "We limited our attention to patients who received any of the 40 regimens most commonly used in calendar year 2009," he explained, noting that, for all of the ABSSSI patients identified, 79% received 1 of the 40 regimens.

Patients were excluded from the study sample if they had a secondary diagnosis of infections of other body sites or organs, except septicemia/bacteremia and systemic inflammatory response syndrome; necrotizing fasciitis; gangrene; ecthyma gangrenosum; osteomyelitis; complications of pregnancy, childbirth, and the puerperium; or impetigo, or if they had plasmapheresis or hemoperfusion performed, he said.

Per study protocol, initial treatment was considered a failure if a patient received a new parenteral antibiotic more than 24 hours following hospital admission, excluding substitution of a similar or narrower spectrum regimen or if a patient underwent drainage, debridement, or amputation more than 72 hours after admission, said Dr. Huang.

The researchers used multivariate logistic regression analysis to predict failure of initial therapy and for significance testing for differences in mortality. They used covariance model analysis to compare hospital length of stay and total inpatient charges. All models were adjusted for covariates, including patient age, sex, comorbidities, clinical status at admission, and hospital characteristics, Dr. Huang stated. All analyses were repeated with initial therapy failure limited to the 72-hour post-admission window to characterize "early" treatment failure, because later failure could be the result of nosocomial infections in patients with long hospitalizations, which would skew cause and effect, he said.

Of the 3,535 patients (mean age 52 years) included in the study sample, 797 (22.5%) experienced initial treatment failure, 66.8% of which occurred within 72 hours of admission, Dr. Huang reported. The most commonly identified pathogens were Staphylococcus aureus (of which 68.4% were methicillin resistant), Pseudomonas aeruginosa, Streptococcus agalactiae, and Escherichia coli. The most frequently prescribed initial antibiotic regimens were vancomycin (22%), cefazolin (14%), and ampicillin/sulbactam (12%). "More than half of the patients [56%] received initial regimens – usually multi-drug – that provided coverage for MRSA [methicillin-resistant Staphylococcus aureus]," he said.

Significant predictors of initial treatment failure were older age, peripheral vascular disease, septicemia/bacteremia, leukopenia, uremia, and hospitalization within the previous 30 days, Dr. Huang reported. Regarding the clinical and economic consequences, initial antibiotic failure was associated with a sevenfold higher rate of death, 5.1 additional hospital days, and additional hospital charges of $13,731, he said.

Dr. Huang acknowledged some of the study’s limitations, including its retrospective design, the inclusion of only those patients receiving the 40 most frequently used regimens, the exclusion of patients with ABSSSI of unknown etiology, and the fact that initial treatment failure could reflect multiple factors, such as the presence of causative organisms that are resistant to the antibiotics that were chosen, the severity of the infection, compromised host immunity, or adverse events.

Dr. Huang is an employee of Forest Research Institute which supported this investigation.

BOSTON – Initial antibiotic therapy failed in nearly 25% of 3,535 adults with acute bacterial skin and skin structure infections in U.S. hospitals between 2000 and 2009, according to a retrospective analysis of data from multiple hospitals.

Initial treatment failure was associated with significantly higher mortality, longer hospital stays, and higher costs of care, Xing-Yue Huang, Ph.D., reported at the annual meeting of the Infectious Diseases Society of America. The case-fatality rate was 1.3% in the 532 patients in the early treatment failure subgroup and 0.2% in the 3,003 successful treatment patients, a significant difference. The mean length of stay and total hospital charges were also significantly increased, at 8.1 days vs. 4.6 days and at $23,383 vs. $12,393, respectively.

The costs and benefits of initial treatment with broad-spectrum and narrower-spectrum regimens needs to be evaluated, Dr. Huang said. "Broad spectrum regimens are generally most effective but their benefits have to be measured against their higher cost. Narrower-spectrum regimens are less expensive but they may pose a higher risk of treatment failure."

Dr. Huang and colleagues used a database to identify all adult patients hospitalized for acute bacterial skin and skin structure infections (ABSSSI), such as abscess, cellulitis, and surgical site infection, between Jan. 1, 2000 and June 30, 2009. All patients in the analysis had at least one positive isolate from skin, wound, or blood cultures within 24 hours of initial clinical presentation. All received parenteral antibiotics for at least 48 hours beginning within 24 hours of hospital admission.

"More than half of the patients received initial regimens – usually multi-drug – that provided coverage for MRSA."

All antibiotics received within 24 hours of admission were considered initial therapy, said Dr. Huang of Forest Research Institute in Jersey City, N.J. "We limited our attention to patients who received any of the 40 regimens most commonly used in calendar year 2009," he explained, noting that, for all of the ABSSSI patients identified, 79% received 1 of the 40 regimens.

Patients were excluded from the study sample if they had a secondary diagnosis of infections of other body sites or organs, except septicemia/bacteremia and systemic inflammatory response syndrome; necrotizing fasciitis; gangrene; ecthyma gangrenosum; osteomyelitis; complications of pregnancy, childbirth, and the puerperium; or impetigo, or if they had plasmapheresis or hemoperfusion performed, he said.

Per study protocol, initial treatment was considered a failure if a patient received a new parenteral antibiotic more than 24 hours following hospital admission, excluding substitution of a similar or narrower spectrum regimen or if a patient underwent drainage, debridement, or amputation more than 72 hours after admission, said Dr. Huang.

The researchers used multivariate logistic regression analysis to predict failure of initial therapy and for significance testing for differences in mortality. They used covariance model analysis to compare hospital length of stay and total inpatient charges. All models were adjusted for covariates, including patient age, sex, comorbidities, clinical status at admission, and hospital characteristics, Dr. Huang stated. All analyses were repeated with initial therapy failure limited to the 72-hour post-admission window to characterize "early" treatment failure, because later failure could be the result of nosocomial infections in patients with long hospitalizations, which would skew cause and effect, he said.

Of the 3,535 patients (mean age 52 years) included in the study sample, 797 (22.5%) experienced initial treatment failure, 66.8% of which occurred within 72 hours of admission, Dr. Huang reported. The most commonly identified pathogens were Staphylococcus aureus (of which 68.4% were methicillin resistant), Pseudomonas aeruginosa, Streptococcus agalactiae, and Escherichia coli. The most frequently prescribed initial antibiotic regimens were vancomycin (22%), cefazolin (14%), and ampicillin/sulbactam (12%). "More than half of the patients [56%] received initial regimens – usually multi-drug – that provided coverage for MRSA [methicillin-resistant Staphylococcus aureus]," he said.

Significant predictors of initial treatment failure were older age, peripheral vascular disease, septicemia/bacteremia, leukopenia, uremia, and hospitalization within the previous 30 days, Dr. Huang reported. Regarding the clinical and economic consequences, initial antibiotic failure was associated with a sevenfold higher rate of death, 5.1 additional hospital days, and additional hospital charges of $13,731, he said.

Dr. Huang acknowledged some of the study’s limitations, including its retrospective design, the inclusion of only those patients receiving the 40 most frequently used regimens, the exclusion of patients with ABSSSI of unknown etiology, and the fact that initial treatment failure could reflect multiple factors, such as the presence of causative organisms that are resistant to the antibiotics that were chosen, the severity of the infection, compromised host immunity, or adverse events.

Dr. Huang is an employee of Forest Research Institute which supported this investigation.

BOSTON – Initial antibiotic therapy failed in nearly 25% of 3,535 adults with acute bacterial skin and skin structure infections in U.S. hospitals between 2000 and 2009, according to a retrospective analysis of data from multiple hospitals.

Initial treatment failure was associated with significantly higher mortality, longer hospital stays, and higher costs of care, Xing-Yue Huang, Ph.D., reported at the annual meeting of the Infectious Diseases Society of America. The case-fatality rate was 1.3% in the 532 patients in the early treatment failure subgroup and 0.2% in the 3,003 successful treatment patients, a significant difference. The mean length of stay and total hospital charges were also significantly increased, at 8.1 days vs. 4.6 days and at $23,383 vs. $12,393, respectively.

The costs and benefits of initial treatment with broad-spectrum and narrower-spectrum regimens needs to be evaluated, Dr. Huang said. "Broad spectrum regimens are generally most effective but their benefits have to be measured against their higher cost. Narrower-spectrum regimens are less expensive but they may pose a higher risk of treatment failure."

Dr. Huang and colleagues used a database to identify all adult patients hospitalized for acute bacterial skin and skin structure infections (ABSSSI), such as abscess, cellulitis, and surgical site infection, between Jan. 1, 2000 and June 30, 2009. All patients in the analysis had at least one positive isolate from skin, wound, or blood cultures within 24 hours of initial clinical presentation. All received parenteral antibiotics for at least 48 hours beginning within 24 hours of hospital admission.

"More than half of the patients received initial regimens – usually multi-drug – that provided coverage for MRSA."

All antibiotics received within 24 hours of admission were considered initial therapy, said Dr. Huang of Forest Research Institute in Jersey City, N.J. "We limited our attention to patients who received any of the 40 regimens most commonly used in calendar year 2009," he explained, noting that, for all of the ABSSSI patients identified, 79% received 1 of the 40 regimens.

Patients were excluded from the study sample if they had a secondary diagnosis of infections of other body sites or organs, except septicemia/bacteremia and systemic inflammatory response syndrome; necrotizing fasciitis; gangrene; ecthyma gangrenosum; osteomyelitis; complications of pregnancy, childbirth, and the puerperium; or impetigo, or if they had plasmapheresis or hemoperfusion performed, he said.

Per study protocol, initial treatment was considered a failure if a patient received a new parenteral antibiotic more than 24 hours following hospital admission, excluding substitution of a similar or narrower spectrum regimen or if a patient underwent drainage, debridement, or amputation more than 72 hours after admission, said Dr. Huang.

The researchers used multivariate logistic regression analysis to predict failure of initial therapy and for significance testing for differences in mortality. They used covariance model analysis to compare hospital length of stay and total inpatient charges. All models were adjusted for covariates, including patient age, sex, comorbidities, clinical status at admission, and hospital characteristics, Dr. Huang stated. All analyses were repeated with initial therapy failure limited to the 72-hour post-admission window to characterize "early" treatment failure, because later failure could be the result of nosocomial infections in patients with long hospitalizations, which would skew cause and effect, he said.

Of the 3,535 patients (mean age 52 years) included in the study sample, 797 (22.5%) experienced initial treatment failure, 66.8% of which occurred within 72 hours of admission, Dr. Huang reported. The most commonly identified pathogens were Staphylococcus aureus (of which 68.4% were methicillin resistant), Pseudomonas aeruginosa, Streptococcus agalactiae, and Escherichia coli. The most frequently prescribed initial antibiotic regimens were vancomycin (22%), cefazolin (14%), and ampicillin/sulbactam (12%). "More than half of the patients [56%] received initial regimens – usually multi-drug – that provided coverage for MRSA [methicillin-resistant Staphylococcus aureus]," he said.

Significant predictors of initial treatment failure were older age, peripheral vascular disease, septicemia/bacteremia, leukopenia, uremia, and hospitalization within the previous 30 days, Dr. Huang reported. Regarding the clinical and economic consequences, initial antibiotic failure was associated with a sevenfold higher rate of death, 5.1 additional hospital days, and additional hospital charges of $13,731, he said.

Dr. Huang acknowledged some of the study’s limitations, including its retrospective design, the inclusion of only those patients receiving the 40 most frequently used regimens, the exclusion of patients with ABSSSI of unknown etiology, and the fact that initial treatment failure could reflect multiple factors, such as the presence of causative organisms that are resistant to the antibiotics that were chosen, the severity of the infection, compromised host immunity, or adverse events.

Dr. Huang is an employee of Forest Research Institute which supported this investigation.

CHICAGO – Antibiotic de-escalation in ICU patients with nosocomial pneumonia in the intensive care unit produced the same clinical outcome – or better – as maintaining broad-spectrum coverage through the treatment course, a study has shown.

Modifying empiric therapy by continuing with narrower-spectrum antibiotics based on culture and antibiotic susceptibility reports not only limits the emergence of multidrug-resistant pathogens, but also reduces resource utilization for the treatment of hospital-acquired pneumonia, ventilator-assisted pneumonia, and health care–associated pneumonia, Chris Destache, Pharm.D., said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The Infectious Diseases Society of America and the American Thoracic Society both advocate early broad-spectrum empiric antibiotics with subsequent streamlining based on the organisms identified and susceptibility patterns in nosocomial pneumonia, but the effect of antibiotic de-escalation on resource utilization, particularly hospital length of stay and cost of hospitalization, has not been examined, Dr. Destache said.

To evaluate the impact of antibiotic de-escalation in the intensive care unit on these resource utilization factors, Dr. Destache of Creighton University in Omaha, Neb., and his colleagues retrospectively studied the charts of patients older than 18 years admitted to the Creighton University Medical Center ICU in 2009 with a presumptive diagnosis of hospital-acquired pneumonia, ventilator-assisted pneumonia, or health care–associated pneumonia, who also had blood or respiratory cultures collected prior to the initiation of antibiotic treatment.

Antibiotic de-escalation was defined as the discontinuation of at least one empiric agent or the change to a narrower-spectrum antibiotic, he said. Patients who received systemic antibacterial, antifungal, or antiviral treatment within 72 hours of their pneumonia diagnosis were excluded from the analysis. The primary study end point was ICU length of stay; secondary end points included total hospital length of stay, in-hospital mortality, and hospitalization costs.

"Culture-negative pneumonias derived the greatest benefit from de-escalation."

Of 378 records identified, 95 patients representing 99 cases of nosocomial pneumonia met the eligibility requirements. "All of the patients had presumptive pneumonia based on [Centers for Disease Control and Prevention] criteria and received broad-spectrum antibiotic therapy based on universal guidelines, and de-escalation was performed in 60 cases," Dr. Destache reported. Universal guidelines call for patients to receive piperacillin-tazobactam, levofloxacin, and vancomycin for at least 24 hours.

Patients in whom the streamlined antibiotic approach was utilized were more likely to be older than those in whom empiric treatment was maintained, with a mean age of 66 years compared with 55.5 years, he said, noting that patients in the de-escalation group were also more likely to have diabetes (38% vs. 18%) and to have cardiovascular disease (38% vs. 15%).

No differences in sequential organ failure assessment scores were observed between the two groups at baseline, although these scores at culture finalization were significantly lower in the de-escalation group, which may have been a factor in the decision to de-escalate, Dr. Destache said.

The ICU length of stay was shorter in the de-escalation group at 9.4 days, compared with 12.8 days in the empiric treatment group, although the difference was not significant. Total length of stay was also shorter, at 15.3 vs. 16.9 days, and hospitalization costs were lower, at $45,640 vs. $60,640, Dr. Destache said at the meeting, sponsored by the American Society for Microbiology. In-hospital mortality was significantly lower in the de-escalation group, at 17% compared with 41%.

Culture was negative in 39 of the de-escalation cases and 18 of the controls, and was positive in 21 of each group, Dr. Destache said. The most common causative pathogens identified in the de-escalation group were methicillin-resistant Staphylococcus aureus (MRSA), followed by methicillin-susceptible S. aureus (MSSA), Pseudomonas aeruginosa, and Streptococcus pneumoniae, he said. In the control group, the most common was MSSA, followed by P. aeruginosa and S. pneumoniae, he said.

In comparing the benefits of antibiotic de-escalation based on culture status, the investigators found that "culture-negative pneumonias derived the greatest benefit from de-escalation," Dr. Destache said. In culture-negative pneumonias, the de-escalation group had an ICU stay of 7.2 days, a total length of stay of 10.4 days, and a mortality of 10%; in the culture-negative control group, ICU stay was 11.9 days, total length of stay was 15.1 days, and mortality was 50%, he said. Culture-positive patients in the de-escalation group stayed in the ICU for 13.6 days and in the hospital for 24.5 days, both of which were statistically similar to the 13.6 days and 18.5 days in the control group; the respective mortality rates were 29% and 33%.

The findings confirm the feasibility and clinical benefit of antimicrobial de-escalation and indicate that the strategy reduces resource utilization, compared with maintaining broad-spectrum coverage, Dr. Destache said. As such, he said, the treatment strategy should be utilized when appropriate as a way to improve antimicrobial stewardship.

Dr. Destache said he had no relevant financial disclosures.

CHICAGO – Antibiotic de-escalation in ICU patients with nosocomial pneumonia in the intensive care unit produced the same clinical outcome – or better – as maintaining broad-spectrum coverage through the treatment course, a study has shown.

Modifying empiric therapy by continuing with narrower-spectrum antibiotics based on culture and antibiotic susceptibility reports not only limits the emergence of multidrug-resistant pathogens, but also reduces resource utilization for the treatment of hospital-acquired pneumonia, ventilator-assisted pneumonia, and health care–associated pneumonia, Chris Destache, Pharm.D., said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The Infectious Diseases Society of America and the American Thoracic Society both advocate early broad-spectrum empiric antibiotics with subsequent streamlining based on the organisms identified and susceptibility patterns in nosocomial pneumonia, but the effect of antibiotic de-escalation on resource utilization, particularly hospital length of stay and cost of hospitalization, has not been examined, Dr. Destache said.

To evaluate the impact of antibiotic de-escalation in the intensive care unit on these resource utilization factors, Dr. Destache of Creighton University in Omaha, Neb., and his colleagues retrospectively studied the charts of patients older than 18 years admitted to the Creighton University Medical Center ICU in 2009 with a presumptive diagnosis of hospital-acquired pneumonia, ventilator-assisted pneumonia, or health care–associated pneumonia, who also had blood or respiratory cultures collected prior to the initiation of antibiotic treatment.

Antibiotic de-escalation was defined as the discontinuation of at least one empiric agent or the change to a narrower-spectrum antibiotic, he said. Patients who received systemic antibacterial, antifungal, or antiviral treatment within 72 hours of their pneumonia diagnosis were excluded from the analysis. The primary study end point was ICU length of stay; secondary end points included total hospital length of stay, in-hospital mortality, and hospitalization costs.

"Culture-negative pneumonias derived the greatest benefit from de-escalation."

Of 378 records identified, 95 patients representing 99 cases of nosocomial pneumonia met the eligibility requirements. "All of the patients had presumptive pneumonia based on [Centers for Disease Control and Prevention] criteria and received broad-spectrum antibiotic therapy based on universal guidelines, and de-escalation was performed in 60 cases," Dr. Destache reported. Universal guidelines call for patients to receive piperacillin-tazobactam, levofloxacin, and vancomycin for at least 24 hours.

Patients in whom the streamlined antibiotic approach was utilized were more likely to be older than those in whom empiric treatment was maintained, with a mean age of 66 years compared with 55.5 years, he said, noting that patients in the de-escalation group were also more likely to have diabetes (38% vs. 18%) and to have cardiovascular disease (38% vs. 15%).

No differences in sequential organ failure assessment scores were observed between the two groups at baseline, although these scores at culture finalization were significantly lower in the de-escalation group, which may have been a factor in the decision to de-escalate, Dr. Destache said.

The ICU length of stay was shorter in the de-escalation group at 9.4 days, compared with 12.8 days in the empiric treatment group, although the difference was not significant. Total length of stay was also shorter, at 15.3 vs. 16.9 days, and hospitalization costs were lower, at $45,640 vs. $60,640, Dr. Destache said at the meeting, sponsored by the American Society for Microbiology. In-hospital mortality was significantly lower in the de-escalation group, at 17% compared with 41%.

Culture was negative in 39 of the de-escalation cases and 18 of the controls, and was positive in 21 of each group, Dr. Destache said. The most common causative pathogens identified in the de-escalation group were methicillin-resistant Staphylococcus aureus (MRSA), followed by methicillin-susceptible S. aureus (MSSA), Pseudomonas aeruginosa, and Streptococcus pneumoniae, he said. In the control group, the most common was MSSA, followed by P. aeruginosa and S. pneumoniae, he said.

In comparing the benefits of antibiotic de-escalation based on culture status, the investigators found that "culture-negative pneumonias derived the greatest benefit from de-escalation," Dr. Destache said. In culture-negative pneumonias, the de-escalation group had an ICU stay of 7.2 days, a total length of stay of 10.4 days, and a mortality of 10%; in the culture-negative control group, ICU stay was 11.9 days, total length of stay was 15.1 days, and mortality was 50%, he said. Culture-positive patients in the de-escalation group stayed in the ICU for 13.6 days and in the hospital for 24.5 days, both of which were statistically similar to the 13.6 days and 18.5 days in the control group; the respective mortality rates were 29% and 33%.

The findings confirm the feasibility and clinical benefit of antimicrobial de-escalation and indicate that the strategy reduces resource utilization, compared with maintaining broad-spectrum coverage, Dr. Destache said. As such, he said, the treatment strategy should be utilized when appropriate as a way to improve antimicrobial stewardship.

Dr. Destache said he had no relevant financial disclosures.

CHICAGO – Antibiotic de-escalation in ICU patients with nosocomial pneumonia in the intensive care unit produced the same clinical outcome – or better – as maintaining broad-spectrum coverage through the treatment course, a study has shown.

Modifying empiric therapy by continuing with narrower-spectrum antibiotics based on culture and antibiotic susceptibility reports not only limits the emergence of multidrug-resistant pathogens, but also reduces resource utilization for the treatment of hospital-acquired pneumonia, ventilator-assisted pneumonia, and health care–associated pneumonia, Chris Destache, Pharm.D., said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The Infectious Diseases Society of America and the American Thoracic Society both advocate early broad-spectrum empiric antibiotics with subsequent streamlining based on the organisms identified and susceptibility patterns in nosocomial pneumonia, but the effect of antibiotic de-escalation on resource utilization, particularly hospital length of stay and cost of hospitalization, has not been examined, Dr. Destache said.

To evaluate the impact of antibiotic de-escalation in the intensive care unit on these resource utilization factors, Dr. Destache of Creighton University in Omaha, Neb., and his colleagues retrospectively studied the charts of patients older than 18 years admitted to the Creighton University Medical Center ICU in 2009 with a presumptive diagnosis of hospital-acquired pneumonia, ventilator-assisted pneumonia, or health care–associated pneumonia, who also had blood or respiratory cultures collected prior to the initiation of antibiotic treatment.

Antibiotic de-escalation was defined as the discontinuation of at least one empiric agent or the change to a narrower-spectrum antibiotic, he said. Patients who received systemic antibacterial, antifungal, or antiviral treatment within 72 hours of their pneumonia diagnosis were excluded from the analysis. The primary study end point was ICU length of stay; secondary end points included total hospital length of stay, in-hospital mortality, and hospitalization costs.

"Culture-negative pneumonias derived the greatest benefit from de-escalation."

Of 378 records identified, 95 patients representing 99 cases of nosocomial pneumonia met the eligibility requirements. "All of the patients had presumptive pneumonia based on [Centers for Disease Control and Prevention] criteria and received broad-spectrum antibiotic therapy based on universal guidelines, and de-escalation was performed in 60 cases," Dr. Destache reported. Universal guidelines call for patients to receive piperacillin-tazobactam, levofloxacin, and vancomycin for at least 24 hours.

Patients in whom the streamlined antibiotic approach was utilized were more likely to be older than those in whom empiric treatment was maintained, with a mean age of 66 years compared with 55.5 years, he said, noting that patients in the de-escalation group were also more likely to have diabetes (38% vs. 18%) and to have cardiovascular disease (38% vs. 15%).

No differences in sequential organ failure assessment scores were observed between the two groups at baseline, although these scores at culture finalization were significantly lower in the de-escalation group, which may have been a factor in the decision to de-escalate, Dr. Destache said.

The ICU length of stay was shorter in the de-escalation group at 9.4 days, compared with 12.8 days in the empiric treatment group, although the difference was not significant. Total length of stay was also shorter, at 15.3 vs. 16.9 days, and hospitalization costs were lower, at $45,640 vs. $60,640, Dr. Destache said at the meeting, sponsored by the American Society for Microbiology. In-hospital mortality was significantly lower in the de-escalation group, at 17% compared with 41%.

Culture was negative in 39 of the de-escalation cases and 18 of the controls, and was positive in 21 of each group, Dr. Destache said. The most common causative pathogens identified in the de-escalation group were methicillin-resistant Staphylococcus aureus (MRSA), followed by methicillin-susceptible S. aureus (MSSA), Pseudomonas aeruginosa, and Streptococcus pneumoniae, he said. In the control group, the most common was MSSA, followed by P. aeruginosa and S. pneumoniae, he said.

In comparing the benefits of antibiotic de-escalation based on culture status, the investigators found that "culture-negative pneumonias derived the greatest benefit from de-escalation," Dr. Destache said. In culture-negative pneumonias, the de-escalation group had an ICU stay of 7.2 days, a total length of stay of 10.4 days, and a mortality of 10%; in the culture-negative control group, ICU stay was 11.9 days, total length of stay was 15.1 days, and mortality was 50%, he said. Culture-positive patients in the de-escalation group stayed in the ICU for 13.6 days and in the hospital for 24.5 days, both of which were statistically similar to the 13.6 days and 18.5 days in the control group; the respective mortality rates were 29% and 33%.

The findings confirm the feasibility and clinical benefit of antimicrobial de-escalation and indicate that the strategy reduces resource utilization, compared with maintaining broad-spectrum coverage, Dr. Destache said. As such, he said, the treatment strategy should be utilized when appropriate as a way to improve antimicrobial stewardship.

Dr. Destache said he had no relevant financial disclosures.

BOSTON – Although copper is not officially considered a precious metal, its antimicrobial properties suggest it may be priceless in the fight against the growing threat of hospital-acquired infections, according to new data presented at the annual meeting of the Infectious Diseases Society of America.

Previously shown to reduce the environmental bioburden when placed into medical intensive care unit (MICU) patient rooms, copper surfaces significantly reduced the acquisition rate of methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus relative to standard-material surfaces in a randomized controlled trial. The study compared the effect of both types of surfaces on the rates of hospital-acquired infections (HAI) in 564 medical intensive care unit patients, reported Dr. Cassandra Salgado of the Medical University of South Carolina in Charleston.

"Environmental surfaces harbor micro-organisms. In an earlier study, we reported that copper surfaces, including bedrails, intravenous poles, overbed tables, chairs, computer monitor bezel, and call button or computer mouse, reduced the median environmental bioburden by more than 97% compared with noncopper surfaces, such as plastic, wood, stainless steel, and chrome, in MICU patient rooms," Dr. Salgado noted. "In this study, our goal was to document the effect of copper surfaces on the rate of health care–acquired infections specifically."

Toward this end, the investigators randomly placed 564 patients admitted to the MICU of three hospitals between July 12, 2010, and May 13, 2011, into rooms with either standard or copper surfaces and followed them prospectively for the development of HAIs, defined by the National Healthcare Safety Network (NHSN), or for new MRSA or VRE colonizations. The clinical characteristics of patients in both groups were similar with respect to age, gender, race, APACHE II score, presence of infection on admission, or MICU length of stay, Dr. Salgado noted. Standard hand washing and environmental cleaning protocols were monitored and maintained throughout the study and there were no differences between the uses of these practices in either setting, she said.

Over the course of the study, 47 patients (8.3%) developed an HAI, including 29 (5.1%) identified as MRSA or VRE, Dr. Salgado reported. The overall incidence of HAI per 1,000 patient days was 12.23, with significantly lower rates observed in copper vs. standard rooms, at 8.95 vs. 15.16 per 1,000 patient days, respectively, she said. In addition, the overall rate of MRSA or VRE acquisition was 7.55 per 1,000 patient days and was significantly lower in copper vs. standard rooms, at 6.12 vs. 8.8 per 1,000 patient days.

In a subpopulation of patients admitted to rooms where all 6 copper-surface objects remained in the room during the entire MICU stay, "there was an even greater effect on reduction of [HAIs] compared with those never exposed to the copper surfaces," Dr. Salgado said. Specifically, the HAI acquisition rate per 1,000 patient days was 6.88 among patients in the full-time copper surface rooms compared with 15.72 among those not exposed to the copper surfaces.

The antimicrobial action of copper is attributed to the release of ions that penetrate the cell walls of microbes and disrupt their ability to function and reproduce, Dr. Salgado explained. Importantly, she added, the effect is continuous, even when combined with other metals.

Considering the contribution of environmental bioburden on the risk of hospital-acquired infections in the MICU as demonstrated by this investigation, efforts to reduce the bioburden, including the replacement of standard surface objects with copper surface alternatives, are warranted, Dr. Salgado stated.

This study was supported by a research grant from the U.S. Department of Defense. Dr. Salgado disclosed no additional conflicts of interest.

BOSTON – Although copper is not officially considered a precious metal, its antimicrobial properties suggest it may be priceless in the fight against the growing threat of hospital-acquired infections, according to new data presented at the annual meeting of the Infectious Diseases Society of America.

Previously shown to reduce the environmental bioburden when placed into medical intensive care unit (MICU) patient rooms, copper surfaces significantly reduced the acquisition rate of methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus relative to standard-material surfaces in a randomized controlled trial. The study compared the effect of both types of surfaces on the rates of hospital-acquired infections (HAI) in 564 medical intensive care unit patients, reported Dr. Cassandra Salgado of the Medical University of South Carolina in Charleston.

"Environmental surfaces harbor micro-organisms. In an earlier study, we reported that copper surfaces, including bedrails, intravenous poles, overbed tables, chairs, computer monitor bezel, and call button or computer mouse, reduced the median environmental bioburden by more than 97% compared with noncopper surfaces, such as plastic, wood, stainless steel, and chrome, in MICU patient rooms," Dr. Salgado noted. "In this study, our goal was to document the effect of copper surfaces on the rate of health care–acquired infections specifically."

Toward this end, the investigators randomly placed 564 patients admitted to the MICU of three hospitals between July 12, 2010, and May 13, 2011, into rooms with either standard or copper surfaces and followed them prospectively for the development of HAIs, defined by the National Healthcare Safety Network (NHSN), or for new MRSA or VRE colonizations. The clinical characteristics of patients in both groups were similar with respect to age, gender, race, APACHE II score, presence of infection on admission, or MICU length of stay, Dr. Salgado noted. Standard hand washing and environmental cleaning protocols were monitored and maintained throughout the study and there were no differences between the uses of these practices in either setting, she said.

Over the course of the study, 47 patients (8.3%) developed an HAI, including 29 (5.1%) identified as MRSA or VRE, Dr. Salgado reported. The overall incidence of HAI per 1,000 patient days was 12.23, with significantly lower rates observed in copper vs. standard rooms, at 8.95 vs. 15.16 per 1,000 patient days, respectively, she said. In addition, the overall rate of MRSA or VRE acquisition was 7.55 per 1,000 patient days and was significantly lower in copper vs. standard rooms, at 6.12 vs. 8.8 per 1,000 patient days.

In a subpopulation of patients admitted to rooms where all 6 copper-surface objects remained in the room during the entire MICU stay, "there was an even greater effect on reduction of [HAIs] compared with those never exposed to the copper surfaces," Dr. Salgado said. Specifically, the HAI acquisition rate per 1,000 patient days was 6.88 among patients in the full-time copper surface rooms compared with 15.72 among those not exposed to the copper surfaces.

The antimicrobial action of copper is attributed to the release of ions that penetrate the cell walls of microbes and disrupt their ability to function and reproduce, Dr. Salgado explained. Importantly, she added, the effect is continuous, even when combined with other metals.

Considering the contribution of environmental bioburden on the risk of hospital-acquired infections in the MICU as demonstrated by this investigation, efforts to reduce the bioburden, including the replacement of standard surface objects with copper surface alternatives, are warranted, Dr. Salgado stated.

This study was supported by a research grant from the U.S. Department of Defense. Dr. Salgado disclosed no additional conflicts of interest.

BOSTON – Although copper is not officially considered a precious metal, its antimicrobial properties suggest it may be priceless in the fight against the growing threat of hospital-acquired infections, according to new data presented at the annual meeting of the Infectious Diseases Society of America.

Previously shown to reduce the environmental bioburden when placed into medical intensive care unit (MICU) patient rooms, copper surfaces significantly reduced the acquisition rate of methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus relative to standard-material surfaces in a randomized controlled trial. The study compared the effect of both types of surfaces on the rates of hospital-acquired infections (HAI) in 564 medical intensive care unit patients, reported Dr. Cassandra Salgado of the Medical University of South Carolina in Charleston.

"Environmental surfaces harbor micro-organisms. In an earlier study, we reported that copper surfaces, including bedrails, intravenous poles, overbed tables, chairs, computer monitor bezel, and call button or computer mouse, reduced the median environmental bioburden by more than 97% compared with noncopper surfaces, such as plastic, wood, stainless steel, and chrome, in MICU patient rooms," Dr. Salgado noted. "In this study, our goal was to document the effect of copper surfaces on the rate of health care–acquired infections specifically."

Toward this end, the investigators randomly placed 564 patients admitted to the MICU of three hospitals between July 12, 2010, and May 13, 2011, into rooms with either standard or copper surfaces and followed them prospectively for the development of HAIs, defined by the National Healthcare Safety Network (NHSN), or for new MRSA or VRE colonizations. The clinical characteristics of patients in both groups were similar with respect to age, gender, race, APACHE II score, presence of infection on admission, or MICU length of stay, Dr. Salgado noted. Standard hand washing and environmental cleaning protocols were monitored and maintained throughout the study and there were no differences between the uses of these practices in either setting, she said.

Over the course of the study, 47 patients (8.3%) developed an HAI, including 29 (5.1%) identified as MRSA or VRE, Dr. Salgado reported. The overall incidence of HAI per 1,000 patient days was 12.23, with significantly lower rates observed in copper vs. standard rooms, at 8.95 vs. 15.16 per 1,000 patient days, respectively, she said. In addition, the overall rate of MRSA or VRE acquisition was 7.55 per 1,000 patient days and was significantly lower in copper vs. standard rooms, at 6.12 vs. 8.8 per 1,000 patient days.

In a subpopulation of patients admitted to rooms where all 6 copper-surface objects remained in the room during the entire MICU stay, "there was an even greater effect on reduction of [HAIs] compared with those never exposed to the copper surfaces," Dr. Salgado said. Specifically, the HAI acquisition rate per 1,000 patient days was 6.88 among patients in the full-time copper surface rooms compared with 15.72 among those not exposed to the copper surfaces.

The antimicrobial action of copper is attributed to the release of ions that penetrate the cell walls of microbes and disrupt their ability to function and reproduce, Dr. Salgado explained. Importantly, she added, the effect is continuous, even when combined with other metals.

Considering the contribution of environmental bioburden on the risk of hospital-acquired infections in the MICU as demonstrated by this investigation, efforts to reduce the bioburden, including the replacement of standard surface objects with copper surface alternatives, are warranted, Dr. Salgado stated.

This study was supported by a research grant from the U.S. Department of Defense. Dr. Salgado disclosed no additional conflicts of interest.

ORLANDO – Cardiometabolic improvements following gastric bypass surgery persist over time, according to findings from the first prospective, long-term controlled trial to focus on gastric bypass patients.

After 6 years of follow-up, patients in the Utah Obesity Study who underwent the bariatric procedure maintained significant total weight loss and significant improvements in cardiovascular and metabolic measures and other disease end points relative to severely obese patients in the control group who did not undergo the surgery, according to Dr. Ted D. Adams, of the University of Utah in Salt Lake City.

Of the 1,156 morbidly obese subjects enrolled in the study, 418 underwent gastric bypass surgery; 417 sought the procedure but were unable to have it, primarily because of lack of health insurance; and 321 were randomly selected as community controls from the Utah Health Family Tree program.

All the participants underwent physical examinations and health evaluations at baseline, 2 years and 6 years, including a physician interview and detailed medical history; resting electro- and echocardiograms; a submaximal exercise treadmill test and electrocardiogram; pulmonary function; limited polysomnography; resting metabolic rate; anthropometry, resting and exercise blood pressure; comprehensive blood chemistry; urinalysis; and dietary, quality of life, and physical activity questionnaires, Dr. Adams stated, noting that the 6-year follow up was "excellent," at 97%.

"In the surgical group, nearly all of the clinical measures improved significantly between the baseline and 2-year exams, and they remained significantly improved, compared with baseline at 6 years," Dr. Adams said. In contrast, he noted, "the clinical variables in the combined control groups changed minimally if at all over the 6-year period."

With respect to weight loss, the total weight reduction from baseline in the surgery group was 35% at 2 years and 28% at 6 years, while the average weight loss in the nonsurgical control subjects was negligible, Dr. Adams reported. Further, the rate of diabetes remission at 6 years was 75% in the surgical group and 1% in the combined controls, and the incidence of diabetes in the surgical and control groups at 6 years was 2% and 16%, respectively, he said.

Cardiac morphology measures were also significantly improved at 6 months in the surgical group, Dr. Adams said. Echocardiography showed reduced left atrial volume and left ventricular mass, improvements that could potentially lead to reduction in obesity-related heart failure over time, he pointed out. The left atrial volume increased in the control group. Significant reductions in waist circumference, systolic blood pressure, heart rate, triglycerides, low-density-lipoprotein cholesterol, and insulin resistance were maintained at 6 years in the surgical group, as were higher levels of high-density lipoprotein cholesterol, he said.

The findings complement other cohort studies in bariatric surgery, Dr. Adams stated. The cohort will continue to be followed to provide additional insight in the long-term durability of the improvements, he said.

Dr. Adams had no conflicts of interest to disclose.

ORLANDO – Cardiometabolic improvements following gastric bypass surgery persist over time, according to findings from the first prospective, long-term controlled trial to focus on gastric bypass patients.

After 6 years of follow-up, patients in the Utah Obesity Study who underwent the bariatric procedure maintained significant total weight loss and significant improvements in cardiovascular and metabolic measures and other disease end points relative to severely obese patients in the control group who did not undergo the surgery, according to Dr. Ted D. Adams, of the University of Utah in Salt Lake City.

Of the 1,156 morbidly obese subjects enrolled in the study, 418 underwent gastric bypass surgery; 417 sought the procedure but were unable to have it, primarily because of lack of health insurance; and 321 were randomly selected as community controls from the Utah Health Family Tree program.

All the participants underwent physical examinations and health evaluations at baseline, 2 years and 6 years, including a physician interview and detailed medical history; resting electro- and echocardiograms; a submaximal exercise treadmill test and electrocardiogram; pulmonary function; limited polysomnography; resting metabolic rate; anthropometry, resting and exercise blood pressure; comprehensive blood chemistry; urinalysis; and dietary, quality of life, and physical activity questionnaires, Dr. Adams stated, noting that the 6-year follow up was "excellent," at 97%.

"In the surgical group, nearly all of the clinical measures improved significantly between the baseline and 2-year exams, and they remained significantly improved, compared with baseline at 6 years," Dr. Adams said. In contrast, he noted, "the clinical variables in the combined control groups changed minimally if at all over the 6-year period."

With respect to weight loss, the total weight reduction from baseline in the surgery group was 35% at 2 years and 28% at 6 years, while the average weight loss in the nonsurgical control subjects was negligible, Dr. Adams reported. Further, the rate of diabetes remission at 6 years was 75% in the surgical group and 1% in the combined controls, and the incidence of diabetes in the surgical and control groups at 6 years was 2% and 16%, respectively, he said.

Cardiac morphology measures were also significantly improved at 6 months in the surgical group, Dr. Adams said. Echocardiography showed reduced left atrial volume and left ventricular mass, improvements that could potentially lead to reduction in obesity-related heart failure over time, he pointed out. The left atrial volume increased in the control group. Significant reductions in waist circumference, systolic blood pressure, heart rate, triglycerides, low-density-lipoprotein cholesterol, and insulin resistance were maintained at 6 years in the surgical group, as were higher levels of high-density lipoprotein cholesterol, he said.

The findings complement other cohort studies in bariatric surgery, Dr. Adams stated. The cohort will continue to be followed to provide additional insight in the long-term durability of the improvements, he said.

Dr. Adams had no conflicts of interest to disclose.

ORLANDO – Cardiometabolic improvements following gastric bypass surgery persist over time, according to findings from the first prospective, long-term controlled trial to focus on gastric bypass patients.

After 6 years of follow-up, patients in the Utah Obesity Study who underwent the bariatric procedure maintained significant total weight loss and significant improvements in cardiovascular and metabolic measures and other disease end points relative to severely obese patients in the control group who did not undergo the surgery, according to Dr. Ted D. Adams, of the University of Utah in Salt Lake City.

Of the 1,156 morbidly obese subjects enrolled in the study, 418 underwent gastric bypass surgery; 417 sought the procedure but were unable to have it, primarily because of lack of health insurance; and 321 were randomly selected as community controls from the Utah Health Family Tree program.

All the participants underwent physical examinations and health evaluations at baseline, 2 years and 6 years, including a physician interview and detailed medical history; resting electro- and echocardiograms; a submaximal exercise treadmill test and electrocardiogram; pulmonary function; limited polysomnography; resting metabolic rate; anthropometry, resting and exercise blood pressure; comprehensive blood chemistry; urinalysis; and dietary, quality of life, and physical activity questionnaires, Dr. Adams stated, noting that the 6-year follow up was "excellent," at 97%.

"In the surgical group, nearly all of the clinical measures improved significantly between the baseline and 2-year exams, and they remained significantly improved, compared with baseline at 6 years," Dr. Adams said. In contrast, he noted, "the clinical variables in the combined control groups changed minimally if at all over the 6-year period."

With respect to weight loss, the total weight reduction from baseline in the surgery group was 35% at 2 years and 28% at 6 years, while the average weight loss in the nonsurgical control subjects was negligible, Dr. Adams reported. Further, the rate of diabetes remission at 6 years was 75% in the surgical group and 1% in the combined controls, and the incidence of diabetes in the surgical and control groups at 6 years was 2% and 16%, respectively, he said.

Cardiac morphology measures were also significantly improved at 6 months in the surgical group, Dr. Adams said. Echocardiography showed reduced left atrial volume and left ventricular mass, improvements that could potentially lead to reduction in obesity-related heart failure over time, he pointed out. The left atrial volume increased in the control group. Significant reductions in waist circumference, systolic blood pressure, heart rate, triglycerides, low-density-lipoprotein cholesterol, and insulin resistance were maintained at 6 years in the surgical group, as were higher levels of high-density lipoprotein cholesterol, he said.

The findings complement other cohort studies in bariatric surgery, Dr. Adams stated. The cohort will continue to be followed to provide additional insight in the long-term durability of the improvements, he said.

Dr. Adams had no conflicts of interest to disclose.

If the sipuleucel-T story were a movie, it would have most of the elements of a blockbuster: money, power, conflict, ethics, and even death threats.

What the prostate cancer vaccine doesn’t have, at least not yet, is the Hollywood ending: the "ah-ha" moment when the protagonist – in this case the first autologous cellular immunotherapy approved for any oncology indication – overcomes unbelievable odds and revolutionizes cancer treatment.

Instead, the momentum that propelled sipuleucel-T along the turbulent path to regulatory approval in April 2010 seems to have stalled. Acceptance in the prostate cancer market has been slower than expected, as sales fell substantially short of consensus estimates for the second quarter. Market analysts are skewering the manufacturer, Dendreon, for grossly overinflating expectations, and, at least in the business sector, the company’s claims that reimbursement concerns are at the root of the sluggish numbers seem to be falling on deaf ears.

©Carme Balcells/iStockphoto.com

Terms such as "implosion" and "derailment" in the business press have the ominous tone of a death knell for sipuleucel-T (Provenge), but oncologists and urologists in the trenches are more forgiving, albeit reasonably cautious. In an ironic twist, interviews show they want more data – a complaint that has dogged sipuleucel-T since the 2007 decision by the Food and Drug Administration’s Center for Biologics Evaluation and Research to act against its advisory panel’s favorable recommendations.

Instead of approval, the agency sent a complete response letter requesting further clinical evidence. Patient and lobbyist picketing outside of FDA offices and cancer conferences, death threats to panelists who had resisted approval, calls for congressional inquiries, and a lawsuit grabbed headlines but did not reverse the decision.

And even after the indication was won, though a Centers for Medicare & Medicaid Services (CMS) panel voted in favor of national coverage for all Medicare beneficiaries beginning July 1 of this year, the panelists expressed only intermediate confidence that the immunotherapy was safe and effective for its labeled indication and very low confidence on off-label use.

Against this backdrop, perhaps it is not surprising that, of 16 physicians approached for this article, many had strong opinions but only a few would speak on the record.

Paradigm Advance Called Huge

Dr. Philip Kantoff, lead author of the pivotal phase-III IMPACT trial in which sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer, maintains that the treatment "represents a huge paradigm advance and is a significant advance for prostate cancer patients."

In the IMPACT trial, sipuleucel-T was associated with a median 4.1-month increase in patient survival, compared with patients in the control condition (25.8 months vs. 21.7 months). The 36-month survival probability in the sipuleucel-T group was estimated to be 31.7%, compared with 23.0% in the placebo group, the investigators reported (N. Engl. J. Med. 2010;363:411-22).

Although many have suggested that the cost of the treatment, at $93,000, may be a barrier to adoption, given the seemingly modest survival benefit in the absence of any prostate-specific antigen (PSA) changes or time-to-disease progression benefit, Dr. Kantoff disagrees. He suggests that it is the fears over timely reimbursement and not the cost of the treatment that is keeping many clinicians from taking the plunge.

"The cost [of sipuleucel-T] treatment is comparable to other cancer therapies; the difference is it is given over a 4-week period rather than over many months," Dr. Kantoff, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, said in an interview.

The "cost-density" of the treatment, rather than the overall cost per se, combined with the requirement by some private payers for special coverage authorization, might be keeping some clinicians from jumping on board, at least until they are more confident in the reimbursement process, he said.

Dendreon has also cited cost-density as an important contributing factor to sipuleucel-T’s lower-than-predicted uptake among clinicians. The company’s Aug. 3, 2011 and Sept. 8, 2011 press releases, in which it reported second-quarter performance statistics and the corporate restructuring plan to compensate for the lack of anticipated growth, respectively, stated that the "primary issue affecting the dynamics of our launch is the reimbursement knowledge around [sipuleucel-T]."

Both communications suggested that the National Coverage Determination (NCD) issued by CMS and assignment of a Q code will lead to increased physician adoption over time.

The direct costs of the treatment, as well as the indirect costs in terms of staff time needed to arrange preauthorization and administer the infusions (three doses at 2-week intervals, with each dose preceded by the leukapheresis procedure 3 days prior), are obvious concerns. Clarifying the reimbursement picture is important, but it will hardly address all of the reasons urologists and oncologists might be reluctant to prescribe sipuleucel-T to their patients.

Clinicians Want Efficacy Measures

That the treatment doesn’t drop patients’ PSA levels or improve time to progression are more pressing considerations, as they relate to the value of the treatment, rather than the cost, clinicians observed in interviews.

"The lack of PSA response, or more specifically, the lack of correlation of PSA changes, makes use of [sipuleucel-T] problematic, as it is unclear from the trial data how to measure treatment efficacy and when to initiate new treatments," said Dr. Edouard J. Trabulsi, a urologist at Thomas Jefferson University and director of the multidisciplinary genitourinary cancer clinic at the Kimmel Cancer Center, both in Philadelphia.

Although the treatment is indicated for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer, the bottom line for Dr. Evan Yu, an oncologist at the University of Washington, Seattle, "is that we don’t know who will benefit from it. We know that the population that received Provenge lived longer in the IMPACT trial, but the fact that there was no improvement in time to progression, and the survival curves didn’t separate until 6 months, tells us that a reasonable portion of patients may not benefit from it."

That said, Dr. Yu added that "there clearly are patients who will receive significant benefit from sipuleucel. We just aren’t sure who those patients are. My best guess is that it may be patients with low-volume disease and slow progression, but it is not always easy to identify this patient population. As a result, predictive and response biomarkers are needed, and Dendreon is doing research in this area."

Although it is clear that clinicians in practice should probably be more selective than the IMPACT population, "we have no data or guidelines to aid us in this selection process," he said.

Indication Limits Likely Patients

The reality, for now, is that sipuleucel-T "is indicated for a very narrow space in prostate cancer – the minimally symptomatic metastatic hormone-refractory patient prior to chemo – and likely will not be expanded widely to the entire advanced prostate cancer spectrum in the absence of additional clinical trial data," said Dr. Trabulsi.

In addition to the relatively narrow patient population for sipuleucel-T, the recent FDA approval of Johnson & Johnson’s abiraterone acetate (Zytiga), an oral inhibitor of testosterone synthesis, in combination with prednisone and the anticipated approval of Medivation’s oral testosterone- and dihydrotestosterone-blocking MVD3100 may have taken some of the wind out of sipuleucel-T’s sails, he noted.

Still, the denouement of the sipuleucel-T story should not be scripted by analysts or angry investors. At the end of the day, the FDA approval of the cancer "vaccine" does represent a milestone in the history of oncology, Dr Trabulsi said.

"[Sipuleucel-T] is very important as it shows a survival benefit and confirms the principle of immunomodulation being effective for prostate cancer," he said. "It also is illustrative of the new process for approval we likely will be seeing for expensive new treatments, as its use off label is severely restricted from earlier prostate cancer populations, which is unprecedented for FDA-approved drugs."

Dr. Kantoff has served as a consultant/adviser for Amgen and has received research funding from Sanofi-Aventis. Dr. Yu has received research funding support from OncoGenex Technologies and is a member of the U.S. Dept. of Defense–supported Prostate Cancer Clinical Trials Consortium. Dr. Trabulsi disclosed no relevant financial relationships.

If the sipuleucel-T story were a movie, it would have most of the elements of a blockbuster: money, power, conflict, ethics, and even death threats.

What the prostate cancer vaccine doesn’t have, at least not yet, is the Hollywood ending: the "ah-ha" moment when the protagonist – in this case the first autologous cellular immunotherapy approved for any oncology indication – overcomes unbelievable odds and revolutionizes cancer treatment.

Instead, the momentum that propelled sipuleucel-T along the turbulent path to regulatory approval in April 2010 seems to have stalled. Acceptance in the prostate cancer market has been slower than expected, as sales fell substantially short of consensus estimates for the second quarter. Market analysts are skewering the manufacturer, Dendreon, for grossly overinflating expectations, and, at least in the business sector, the company’s claims that reimbursement concerns are at the root of the sluggish numbers seem to be falling on deaf ears.

©Carme Balcells/iStockphoto.com

Terms such as "implosion" and "derailment" in the business press have the ominous tone of a death knell for sipuleucel-T (Provenge), but oncologists and urologists in the trenches are more forgiving, albeit reasonably cautious. In an ironic twist, interviews show they want more data – a complaint that has dogged sipuleucel-T since the 2007 decision by the Food and Drug Administration’s Center for Biologics Evaluation and Research to act against its advisory panel’s favorable recommendations.

Instead of approval, the agency sent a complete response letter requesting further clinical evidence. Patient and lobbyist picketing outside of FDA offices and cancer conferences, death threats to panelists who had resisted approval, calls for congressional inquiries, and a lawsuit grabbed headlines but did not reverse the decision.

And even after the indication was won, though a Centers for Medicare & Medicaid Services (CMS) panel voted in favor of national coverage for all Medicare beneficiaries beginning July 1 of this year, the panelists expressed only intermediate confidence that the immunotherapy was safe and effective for its labeled indication and very low confidence on off-label use.

Against this backdrop, perhaps it is not surprising that, of 16 physicians approached for this article, many had strong opinions but only a few would speak on the record.

Paradigm Advance Called Huge

Dr. Philip Kantoff, lead author of the pivotal phase-III IMPACT trial in which sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer, maintains that the treatment "represents a huge paradigm advance and is a significant advance for prostate cancer patients."

In the IMPACT trial, sipuleucel-T was associated with a median 4.1-month increase in patient survival, compared with patients in the control condition (25.8 months vs. 21.7 months). The 36-month survival probability in the sipuleucel-T group was estimated to be 31.7%, compared with 23.0% in the placebo group, the investigators reported (N. Engl. J. Med. 2010;363:411-22).

Although many have suggested that the cost of the treatment, at $93,000, may be a barrier to adoption, given the seemingly modest survival benefit in the absence of any prostate-specific antigen (PSA) changes or time-to-disease progression benefit, Dr. Kantoff disagrees. He suggests that it is the fears over timely reimbursement and not the cost of the treatment that is keeping many clinicians from taking the plunge.

"The cost [of sipuleucel-T] treatment is comparable to other cancer therapies; the difference is it is given over a 4-week period rather than over many months," Dr. Kantoff, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, said in an interview.

The "cost-density" of the treatment, rather than the overall cost per se, combined with the requirement by some private payers for special coverage authorization, might be keeping some clinicians from jumping on board, at least until they are more confident in the reimbursement process, he said.

Dendreon has also cited cost-density as an important contributing factor to sipuleucel-T’s lower-than-predicted uptake among clinicians. The company’s Aug. 3, 2011 and Sept. 8, 2011 press releases, in which it reported second-quarter performance statistics and the corporate restructuring plan to compensate for the lack of anticipated growth, respectively, stated that the "primary issue affecting the dynamics of our launch is the reimbursement knowledge around [sipuleucel-T]."

Both communications suggested that the National Coverage Determination (NCD) issued by CMS and assignment of a Q code will lead to increased physician adoption over time.

The direct costs of the treatment, as well as the indirect costs in terms of staff time needed to arrange preauthorization and administer the infusions (three doses at 2-week intervals, with each dose preceded by the leukapheresis procedure 3 days prior), are obvious concerns. Clarifying the reimbursement picture is important, but it will hardly address all of the reasons urologists and oncologists might be reluctant to prescribe sipuleucel-T to their patients.

Clinicians Want Efficacy Measures

That the treatment doesn’t drop patients’ PSA levels or improve time to progression are more pressing considerations, as they relate to the value of the treatment, rather than the cost, clinicians observed in interviews.

"The lack of PSA response, or more specifically, the lack of correlation of PSA changes, makes use of [sipuleucel-T] problematic, as it is unclear from the trial data how to measure treatment efficacy and when to initiate new treatments," said Dr. Edouard J. Trabulsi, a urologist at Thomas Jefferson University and director of the multidisciplinary genitourinary cancer clinic at the Kimmel Cancer Center, both in Philadelphia.

Although the treatment is indicated for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer, the bottom line for Dr. Evan Yu, an oncologist at the University of Washington, Seattle, "is that we don’t know who will benefit from it. We know that the population that received Provenge lived longer in the IMPACT trial, but the fact that there was no improvement in time to progression, and the survival curves didn’t separate until 6 months, tells us that a reasonable portion of patients may not benefit from it."

That said, Dr. Yu added that "there clearly are patients who will receive significant benefit from sipuleucel. We just aren’t sure who those patients are. My best guess is that it may be patients with low-volume disease and slow progression, but it is not always easy to identify this patient population. As a result, predictive and response biomarkers are needed, and Dendreon is doing research in this area."

Although it is clear that clinicians in practice should probably be more selective than the IMPACT population, "we have no data or guidelines to aid us in this selection process," he said.

Indication Limits Likely Patients

The reality, for now, is that sipuleucel-T "is indicated for a very narrow space in prostate cancer – the minimally symptomatic metastatic hormone-refractory patient prior to chemo – and likely will not be expanded widely to the entire advanced prostate cancer spectrum in the absence of additional clinical trial data," said Dr. Trabulsi.

In addition to the relatively narrow patient population for sipuleucel-T, the recent FDA approval of Johnson & Johnson’s abiraterone acetate (Zytiga), an oral inhibitor of testosterone synthesis, in combination with prednisone and the anticipated approval of Medivation’s oral testosterone- and dihydrotestosterone-blocking MVD3100 may have taken some of the wind out of sipuleucel-T’s sails, he noted.

Still, the denouement of the sipuleucel-T story should not be scripted by analysts or angry investors. At the end of the day, the FDA approval of the cancer "vaccine" does represent a milestone in the history of oncology, Dr Trabulsi said.

"[Sipuleucel-T] is very important as it shows a survival benefit and confirms the principle of immunomodulation being effective for prostate cancer," he said. "It also is illustrative of the new process for approval we likely will be seeing for expensive new treatments, as its use off label is severely restricted from earlier prostate cancer populations, which is unprecedented for FDA-approved drugs."

Dr. Kantoff has served as a consultant/adviser for Amgen and has received research funding from Sanofi-Aventis. Dr. Yu has received research funding support from OncoGenex Technologies and is a member of the U.S. Dept. of Defense–supported Prostate Cancer Clinical Trials Consortium. Dr. Trabulsi disclosed no relevant financial relationships.

If the sipuleucel-T story were a movie, it would have most of the elements of a blockbuster: money, power, conflict, ethics, and even death threats.

What the prostate cancer vaccine doesn’t have, at least not yet, is the Hollywood ending: the "ah-ha" moment when the protagonist – in this case the first autologous cellular immunotherapy approved for any oncology indication – overcomes unbelievable odds and revolutionizes cancer treatment.

Instead, the momentum that propelled sipuleucel-T along the turbulent path to regulatory approval in April 2010 seems to have stalled. Acceptance in the prostate cancer market has been slower than expected, as sales fell substantially short of consensus estimates for the second quarter. Market analysts are skewering the manufacturer, Dendreon, for grossly overinflating expectations, and, at least in the business sector, the company’s claims that reimbursement concerns are at the root of the sluggish numbers seem to be falling on deaf ears.

©Carme Balcells/iStockphoto.com

Terms such as "implosion" and "derailment" in the business press have the ominous tone of a death knell for sipuleucel-T (Provenge), but oncologists and urologists in the trenches are more forgiving, albeit reasonably cautious. In an ironic twist, interviews show they want more data – a complaint that has dogged sipuleucel-T since the 2007 decision by the Food and Drug Administration’s Center for Biologics Evaluation and Research to act against its advisory panel’s favorable recommendations.

Instead of approval, the agency sent a complete response letter requesting further clinical evidence. Patient and lobbyist picketing outside of FDA offices and cancer conferences, death threats to panelists who had resisted approval, calls for congressional inquiries, and a lawsuit grabbed headlines but did not reverse the decision.

And even after the indication was won, though a Centers for Medicare & Medicaid Services (CMS) panel voted in favor of national coverage for all Medicare beneficiaries beginning July 1 of this year, the panelists expressed only intermediate confidence that the immunotherapy was safe and effective for its labeled indication and very low confidence on off-label use.

Against this backdrop, perhaps it is not surprising that, of 16 physicians approached for this article, many had strong opinions but only a few would speak on the record.

Paradigm Advance Called Huge

Dr. Philip Kantoff, lead author of the pivotal phase-III IMPACT trial in which sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer, maintains that the treatment "represents a huge paradigm advance and is a significant advance for prostate cancer patients."

In the IMPACT trial, sipuleucel-T was associated with a median 4.1-month increase in patient survival, compared with patients in the control condition (25.8 months vs. 21.7 months). The 36-month survival probability in the sipuleucel-T group was estimated to be 31.7%, compared with 23.0% in the placebo group, the investigators reported (N. Engl. J. Med. 2010;363:411-22).

Although many have suggested that the cost of the treatment, at $93,000, may be a barrier to adoption, given the seemingly modest survival benefit in the absence of any prostate-specific antigen (PSA) changes or time-to-disease progression benefit, Dr. Kantoff disagrees. He suggests that it is the fears over timely reimbursement and not the cost of the treatment that is keeping many clinicians from taking the plunge.

"The cost [of sipuleucel-T] treatment is comparable to other cancer therapies; the difference is it is given over a 4-week period rather than over many months," Dr. Kantoff, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, said in an interview.

The "cost-density" of the treatment, rather than the overall cost per se, combined with the requirement by some private payers for special coverage authorization, might be keeping some clinicians from jumping on board, at least until they are more confident in the reimbursement process, he said.

Dendreon has also cited cost-density as an important contributing factor to sipuleucel-T’s lower-than-predicted uptake among clinicians. The company’s Aug. 3, 2011 and Sept. 8, 2011 press releases, in which it reported second-quarter performance statistics and the corporate restructuring plan to compensate for the lack of anticipated growth, respectively, stated that the "primary issue affecting the dynamics of our launch is the reimbursement knowledge around [sipuleucel-T]."

Both communications suggested that the National Coverage Determination (NCD) issued by CMS and assignment of a Q code will lead to increased physician adoption over time.

The direct costs of the treatment, as well as the indirect costs in terms of staff time needed to arrange preauthorization and administer the infusions (three doses at 2-week intervals, with each dose preceded by the leukapheresis procedure 3 days prior), are obvious concerns. Clarifying the reimbursement picture is important, but it will hardly address all of the reasons urologists and oncologists might be reluctant to prescribe sipuleucel-T to their patients.

Clinicians Want Efficacy Measures

That the treatment doesn’t drop patients’ PSA levels or improve time to progression are more pressing considerations, as they relate to the value of the treatment, rather than the cost, clinicians observed in interviews.

"The lack of PSA response, or more specifically, the lack of correlation of PSA changes, makes use of [sipuleucel-T] problematic, as it is unclear from the trial data how to measure treatment efficacy and when to initiate new treatments," said Dr. Edouard J. Trabulsi, a urologist at Thomas Jefferson University and director of the multidisciplinary genitourinary cancer clinic at the Kimmel Cancer Center, both in Philadelphia.

Although the treatment is indicated for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer, the bottom line for Dr. Evan Yu, an oncologist at the University of Washington, Seattle, "is that we don’t know who will benefit from it. We know that the population that received Provenge lived longer in the IMPACT trial, but the fact that there was no improvement in time to progression, and the survival curves didn’t separate until 6 months, tells us that a reasonable portion of patients may not benefit from it."

That said, Dr. Yu added that "there clearly are patients who will receive significant benefit from sipuleucel. We just aren’t sure who those patients are. My best guess is that it may be patients with low-volume disease and slow progression, but it is not always easy to identify this patient population. As a result, predictive and response biomarkers are needed, and Dendreon is doing research in this area."

Although it is clear that clinicians in practice should probably be more selective than the IMPACT population, "we have no data or guidelines to aid us in this selection process," he said.

Indication Limits Likely Patients

The reality, for now, is that sipuleucel-T "is indicated for a very narrow space in prostate cancer – the minimally symptomatic metastatic hormone-refractory patient prior to chemo – and likely will not be expanded widely to the entire advanced prostate cancer spectrum in the absence of additional clinical trial data," said Dr. Trabulsi.

In addition to the relatively narrow patient population for sipuleucel-T, the recent FDA approval of Johnson & Johnson’s abiraterone acetate (Zytiga), an oral inhibitor of testosterone synthesis, in combination with prednisone and the anticipated approval of Medivation’s oral testosterone- and dihydrotestosterone-blocking MVD3100 may have taken some of the wind out of sipuleucel-T’s sails, he noted.

Still, the denouement of the sipuleucel-T story should not be scripted by analysts or angry investors. At the end of the day, the FDA approval of the cancer "vaccine" does represent a milestone in the history of oncology, Dr Trabulsi said.

"[Sipuleucel-T] is very important as it shows a survival benefit and confirms the principle of immunomodulation being effective for prostate cancer," he said. "It also is illustrative of the new process for approval we likely will be seeing for expensive new treatments, as its use off label is severely restricted from earlier prostate cancer populations, which is unprecedented for FDA-approved drugs."

Dr. Kantoff has served as a consultant/adviser for Amgen and has received research funding from Sanofi-Aventis. Dr. Yu has received research funding support from OncoGenex Technologies and is a member of the U.S. Dept. of Defense–supported Prostate Cancer Clinical Trials Consortium. Dr. Trabulsi disclosed no relevant financial relationships.

LONDON – Raloxifene did not increase lupus activity or flares in a 1-year trial of post-menopausal women who had systemic lupus erythematosus without hypercoagulability risk factors, Dr. Chi Chiu Mok reported.

Raloxifene has been shown in previous studies to preserve bone mineral density (BMD) after menopause in women with systemic lupus erythematosus (SLE). However, mild to moderate disease flares occurred in some patients in these small studies. Lupus flares are rare in postmenopausal women, so this finding suggested a possible association between raloxifene (Evista) and disease activity, explained Dr. Mok of Tuen Mun Hospital in Hong Kong.

Dr. Mok and his colleagues analyzed subgroup data from a 12-month randomized controlled trial that assessed bone turnover and BMD in 62 postmenopausal women who had no risk factors for arterial or venous thromboembolism and were being treated with glucocorticoids. The women were randomized to receive either 60 mg/day of raloxifene (30) or placebo (32) in addition to 1,000 mg/day of calcium and 0.25 mcg/day of calcitriol, Dr. Mok explained. “The primary study outcome was bone mineral density of the hip and spine, and secondary outcomes were bone-turnover markers and new vertebral fractures at 12 months,” he said.

In the overall study population, the mean duration of menopause was 7.2 years, the mean duration of treatment with prednisolone (mean daily dose of 6.8 mg) was 87 months, and the mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score at entry was 1.8, Dr. Mok said. The basic clinical characteristics were similar between the two groups, he noted.

After 12 months, “there was a significant gain in bone mineral density at the lumbar spine in the raloxifene patients but not in the placebo group. And there was a gain, though not significant, in the bone mineral density of the hip in the raloxifene-treated patients,” Dr. Mok reported. Similarly, markers of bone resorption and formation decreased significantly in the treatment group, he said.

At 12 months, there was no significant difference in the mean area under the curve SLEDAI scores, which were 18.7 in the raloxifene group and 20.3 in the placebo group, or in the mean area under the curve patient global assessments, which were 2.2 for raloxifene patients and 2.3 for placebo patients, Dr. Mok said.

Regarding disease flares, “there were three episodes of mild to moderate flares in the raloxifene patients, compared with nine in the placebo group,” he stated.

The researchers also assessed the effect of raloxifene on homocysteine and high-sensitivity C-reactive protein (hsCRP) levels and changes in atherosclerotic risk factors. They observed a trend of decrease in homocysteine level in raloxifene patients only, no statistically significant changes in hsCRP levels in either group, significant increases in total and LDL cholesterol in the placebo-treated patients only, and no significant changes in systolic and diastolic blood pressure values in either group, Dr. Mok stated. “In the treatment group, [raloxifene] was well tolerated and there were no thromboembolic complications,” he said.

“As previous studies have shown, raloxifene offers protection against bone mineral density loss in postmenopausal women with lupus receiving long-term glucocorticoids,” Dr. Mok said in an interview. “These results show that it's safe and well tolerated in this population and does not increase lupus disease activity or disease flares.”

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – Raloxifene did not increase lupus activity or flares in a 1-year trial of post-menopausal women who had systemic lupus erythematosus without hypercoagulability risk factors, Dr. Chi Chiu Mok reported.

Raloxifene has been shown in previous studies to preserve bone mineral density (BMD) after menopause in women with systemic lupus erythematosus (SLE). However, mild to moderate disease flares occurred in some patients in these small studies. Lupus flares are rare in postmenopausal women, so this finding suggested a possible association between raloxifene (Evista) and disease activity, explained Dr. Mok of Tuen Mun Hospital in Hong Kong.

Dr. Mok and his colleagues analyzed subgroup data from a 12-month randomized controlled trial that assessed bone turnover and BMD in 62 postmenopausal women who had no risk factors for arterial or venous thromboembolism and were being treated with glucocorticoids. The women were randomized to receive either 60 mg/day of raloxifene (30) or placebo (32) in addition to 1,000 mg/day of calcium and 0.25 mcg/day of calcitriol, Dr. Mok explained. “The primary study outcome was bone mineral density of the hip and spine, and secondary outcomes were bone-turnover markers and new vertebral fractures at 12 months,” he said.

In the overall study population, the mean duration of menopause was 7.2 years, the mean duration of treatment with prednisolone (mean daily dose of 6.8 mg) was 87 months, and the mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score at entry was 1.8, Dr. Mok said. The basic clinical characteristics were similar between the two groups, he noted.

After 12 months, “there was a significant gain in bone mineral density at the lumbar spine in the raloxifene patients but not in the placebo group. And there was a gain, though not significant, in the bone mineral density of the hip in the raloxifene-treated patients,” Dr. Mok reported. Similarly, markers of bone resorption and formation decreased significantly in the treatment group, he said.

At 12 months, there was no significant difference in the mean area under the curve SLEDAI scores, which were 18.7 in the raloxifene group and 20.3 in the placebo group, or in the mean area under the curve patient global assessments, which were 2.2 for raloxifene patients and 2.3 for placebo patients, Dr. Mok said.

Regarding disease flares, “there were three episodes of mild to moderate flares in the raloxifene patients, compared with nine in the placebo group,” he stated.

The researchers also assessed the effect of raloxifene on homocysteine and high-sensitivity C-reactive protein (hsCRP) levels and changes in atherosclerotic risk factors. They observed a trend of decrease in homocysteine level in raloxifene patients only, no statistically significant changes in hsCRP levels in either group, significant increases in total and LDL cholesterol in the placebo-treated patients only, and no significant changes in systolic and diastolic blood pressure values in either group, Dr. Mok stated. “In the treatment group, [raloxifene] was well tolerated and there were no thromboembolic complications,” he said.

“As previous studies have shown, raloxifene offers protection against bone mineral density loss in postmenopausal women with lupus receiving long-term glucocorticoids,” Dr. Mok said in an interview. “These results show that it's safe and well tolerated in this population and does not increase lupus disease activity or disease flares.”

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – Raloxifene did not increase lupus activity or flares in a 1-year trial of post-menopausal women who had systemic lupus erythematosus without hypercoagulability risk factors, Dr. Chi Chiu Mok reported.

Raloxifene has been shown in previous studies to preserve bone mineral density (BMD) after menopause in women with systemic lupus erythematosus (SLE). However, mild to moderate disease flares occurred in some patients in these small studies. Lupus flares are rare in postmenopausal women, so this finding suggested a possible association between raloxifene (Evista) and disease activity, explained Dr. Mok of Tuen Mun Hospital in Hong Kong.

Dr. Mok and his colleagues analyzed subgroup data from a 12-month randomized controlled trial that assessed bone turnover and BMD in 62 postmenopausal women who had no risk factors for arterial or venous thromboembolism and were being treated with glucocorticoids. The women were randomized to receive either 60 mg/day of raloxifene (30) or placebo (32) in addition to 1,000 mg/day of calcium and 0.25 mcg/day of calcitriol, Dr. Mok explained. “The primary study outcome was bone mineral density of the hip and spine, and secondary outcomes were bone-turnover markers and new vertebral fractures at 12 months,” he said.

In the overall study population, the mean duration of menopause was 7.2 years, the mean duration of treatment with prednisolone (mean daily dose of 6.8 mg) was 87 months, and the mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score at entry was 1.8, Dr. Mok said. The basic clinical characteristics were similar between the two groups, he noted.

After 12 months, “there was a significant gain in bone mineral density at the lumbar spine in the raloxifene patients but not in the placebo group. And there was a gain, though not significant, in the bone mineral density of the hip in the raloxifene-treated patients,” Dr. Mok reported. Similarly, markers of bone resorption and formation decreased significantly in the treatment group, he said.

At 12 months, there was no significant difference in the mean area under the curve SLEDAI scores, which were 18.7 in the raloxifene group and 20.3 in the placebo group, or in the mean area under the curve patient global assessments, which were 2.2 for raloxifene patients and 2.3 for placebo patients, Dr. Mok said.

Regarding disease flares, “there were three episodes of mild to moderate flares in the raloxifene patients, compared with nine in the placebo group,” he stated.

The researchers also assessed the effect of raloxifene on homocysteine and high-sensitivity C-reactive protein (hsCRP) levels and changes in atherosclerotic risk factors. They observed a trend of decrease in homocysteine level in raloxifene patients only, no statistically significant changes in hsCRP levels in either group, significant increases in total and LDL cholesterol in the placebo-treated patients only, and no significant changes in systolic and diastolic blood pressure values in either group, Dr. Mok stated. “In the treatment group, [raloxifene] was well tolerated and there were no thromboembolic complications,” he said.

“As previous studies have shown, raloxifene offers protection against bone mineral density loss in postmenopausal women with lupus receiving long-term glucocorticoids,” Dr. Mok said in an interview. “These results show that it's safe and well tolerated in this population and does not increase lupus disease activity or disease flares.”

Dr. Mok disclosed having no financial conflicts of interest.

CHICAGO – The rate of skin and soft tissue infections in Americans younger than 65 years old increased by approximately 11% between 2005 and 2008, a study has shown.

Using national projections of incidence and costs from a population of commercially insured individuals, the study indicated "that more than 11 million skin and soft tissue infections occur annually in Americans younger than 65 years old, with an annual associated medical cost of almost $24 billion," Dr. Loren G. Miller reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Although incidence data from the early 2000s linked the emergence of community-associated methicillin-resistant Staphylococcus aureus with a dramatic increase in skin and soft tissue infections [SSTIs], "more recent data on the [SSTI] incidence rates and treatment costs are lacking," Dr. Miller said in a poster presentation.

To estimate updated SSTI incidence rates and the related health care utilization costs, he and his colleagues examined ambulatory and inpatient data from 2005 to 2008 for approximately 24 million Americans between 0 and 64 years using the HealthCore Integrated Research Database, a longitudinal health care claims database.

The investigators extracted data for SSTI diagnoses based on ICD-9 codes and estimated the annual SSTI incidence by diagnosis setting and age group. They also estimated complication rates by SSTI type, the direct medical costs associated with SSTI claims, and national projections of SSTI cases, explained Dr. Miller, director of the infection care program at Harbor-UCLA Medical Center in Torrance, Calif.

From the 2005 to 2008 data, "we identified more than 1.5 million [SSTIs], 95% of which were diagnosed in the ambulatory setting," he said. Of the 1,506,882 SSTIs identified, 60% were classified as abscesses or cellulitis.

During the 4-year period of investigation, the incidence of SSTIs increased from 41.0/1,000 person-years to 45.5/1,000, with the highest incidence of both ambulatory onset and inpatient onset observed in those aged 45-64 years. In this age group the incidence of SSTI was 42.26/1,000 person-years with ambulatory onset and 3.39 with inpatient onset.

A total of 1.2% of the ambulatory group and 24.1% of the inpatient group developed at least one SSTI complication, including myositis, osteomyelitis, gangrene, and sepsis. In addition, 1.48% of the ambulatory group and 9.8% of the inpatient group required subsequent hospitalization for SSTI-related complications.

"The complication rates depended on the type of infection and the setting of the initial diagnosis," he said. In both the ambulatory-onset and inpatient-onset groups, decubitus ulcers and nonhealing surgical wounds were associated with the highest complication rates.

Based on the acquired data, the 2010 projected annual cost associated with SSTIs in the United States in this population was approximately $24 billion, an amount comparable to the overall U.S. hospital costs associated with back pain, cardiac dysrhythmias, or acute cerebrovascular disease. The mean direct medical cost associated with an initial SSTI was $2,107, and the median cost was $249.

The generalizability of the findings is limited by the study design, specifically the lack of data for individuals older than 64 years and those without insurance, the absence of data on the microbiologic etiology of the SSTIs, and the fact that the accuracy of ICD-9 SSTI diagnoses are not well validated. Still, the estimated incidence of 4 SSTIs per 100 person-years in this population and the high associated health care costs suggest that targeted interventions to prevent SSTIs "could reduce morbidity and health care resource utilization substantially," Dr. Miller concluded.

Dr. Miller disclosed financial relationships with GlaxoSmithKline, Cubist, and Pfizer. GlaxoSmithKline provided funding for this study.

CHICAGO – The rate of skin and soft tissue infections in Americans younger than 65 years old increased by approximately 11% between 2005 and 2008, a study has shown.

Using national projections of incidence and costs from a population of commercially insured individuals, the study indicated "that more than 11 million skin and soft tissue infections occur annually in Americans younger than 65 years old, with an annual associated medical cost of almost $24 billion," Dr. Loren G. Miller reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Although incidence data from the early 2000s linked the emergence of community-associated methicillin-resistant Staphylococcus aureus with a dramatic increase in skin and soft tissue infections [SSTIs], "more recent data on the [SSTI] incidence rates and treatment costs are lacking," Dr. Miller said in a poster presentation.

To estimate updated SSTI incidence rates and the related health care utilization costs, he and his colleagues examined ambulatory and inpatient data from 2005 to 2008 for approximately 24 million Americans between 0 and 64 years using the HealthCore Integrated Research Database, a longitudinal health care claims database.

The investigators extracted data for SSTI diagnoses based on ICD-9 codes and estimated the annual SSTI incidence by diagnosis setting and age group. They also estimated complication rates by SSTI type, the direct medical costs associated with SSTI claims, and national projections of SSTI cases, explained Dr. Miller, director of the infection care program at Harbor-UCLA Medical Center in Torrance, Calif.

From the 2005 to 2008 data, "we identified more than 1.5 million [SSTIs], 95% of which were diagnosed in the ambulatory setting," he said. Of the 1,506,882 SSTIs identified, 60% were classified as abscesses or cellulitis.

During the 4-year period of investigation, the incidence of SSTIs increased from 41.0/1,000 person-years to 45.5/1,000, with the highest incidence of both ambulatory onset and inpatient onset observed in those aged 45-64 years. In this age group the incidence of SSTI was 42.26/1,000 person-years with ambulatory onset and 3.39 with inpatient onset.

A total of 1.2% of the ambulatory group and 24.1% of the inpatient group developed at least one SSTI complication, including myositis, osteomyelitis, gangrene, and sepsis. In addition, 1.48% of the ambulatory group and 9.8% of the inpatient group required subsequent hospitalization for SSTI-related complications.

"The complication rates depended on the type of infection and the setting of the initial diagnosis," he said. In both the ambulatory-onset and inpatient-onset groups, decubitus ulcers and nonhealing surgical wounds were associated with the highest complication rates.

Based on the acquired data, the 2010 projected annual cost associated with SSTIs in the United States in this population was approximately $24 billion, an amount comparable to the overall U.S. hospital costs associated with back pain, cardiac dysrhythmias, or acute cerebrovascular disease. The mean direct medical cost associated with an initial SSTI was $2,107, and the median cost was $249.

The generalizability of the findings is limited by the study design, specifically the lack of data for individuals older than 64 years and those without insurance, the absence of data on the microbiologic etiology of the SSTIs, and the fact that the accuracy of ICD-9 SSTI diagnoses are not well validated. Still, the estimated incidence of 4 SSTIs per 100 person-years in this population and the high associated health care costs suggest that targeted interventions to prevent SSTIs "could reduce morbidity and health care resource utilization substantially," Dr. Miller concluded.

Dr. Miller disclosed financial relationships with GlaxoSmithKline, Cubist, and Pfizer. GlaxoSmithKline provided funding for this study.

CHICAGO – The rate of skin and soft tissue infections in Americans younger than 65 years old increased by approximately 11% between 2005 and 2008, a study has shown.

Using national projections of incidence and costs from a population of commercially insured individuals, the study indicated "that more than 11 million skin and soft tissue infections occur annually in Americans younger than 65 years old, with an annual associated medical cost of almost $24 billion," Dr. Loren G. Miller reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Although incidence data from the early 2000s linked the emergence of community-associated methicillin-resistant Staphylococcus aureus with a dramatic increase in skin and soft tissue infections [SSTIs], "more recent data on the [SSTI] incidence rates and treatment costs are lacking," Dr. Miller said in a poster presentation.

To estimate updated SSTI incidence rates and the related health care utilization costs, he and his colleagues examined ambulatory and inpatient data from 2005 to 2008 for approximately 24 million Americans between 0 and 64 years using the HealthCore Integrated Research Database, a longitudinal health care claims database.

The investigators extracted data for SSTI diagnoses based on ICD-9 codes and estimated the annual SSTI incidence by diagnosis setting and age group. They also estimated complication rates by SSTI type, the direct medical costs associated with SSTI claims, and national projections of SSTI cases, explained Dr. Miller, director of the infection care program at Harbor-UCLA Medical Center in Torrance, Calif.

From the 2005 to 2008 data, "we identified more than 1.5 million [SSTIs], 95% of which were diagnosed in the ambulatory setting," he said. Of the 1,506,882 SSTIs identified, 60% were classified as abscesses or cellulitis.

During the 4-year period of investigation, the incidence of SSTIs increased from 41.0/1,000 person-years to 45.5/1,000, with the highest incidence of both ambulatory onset and inpatient onset observed in those aged 45-64 years. In this age group the incidence of SSTI was 42.26/1,000 person-years with ambulatory onset and 3.39 with inpatient onset.

A total of 1.2% of the ambulatory group and 24.1% of the inpatient group developed at least one SSTI complication, including myositis, osteomyelitis, gangrene, and sepsis. In addition, 1.48% of the ambulatory group and 9.8% of the inpatient group required subsequent hospitalization for SSTI-related complications.

"The complication rates depended on the type of infection and the setting of the initial diagnosis," he said. In both the ambulatory-onset and inpatient-onset groups, decubitus ulcers and nonhealing surgical wounds were associated with the highest complication rates.

Based on the acquired data, the 2010 projected annual cost associated with SSTIs in the United States in this population was approximately $24 billion, an amount comparable to the overall U.S. hospital costs associated with back pain, cardiac dysrhythmias, or acute cerebrovascular disease. The mean direct medical cost associated with an initial SSTI was $2,107, and the median cost was $249.

The generalizability of the findings is limited by the study design, specifically the lack of data for individuals older than 64 years and those without insurance, the absence of data on the microbiologic etiology of the SSTIs, and the fact that the accuracy of ICD-9 SSTI diagnoses are not well validated. Still, the estimated incidence of 4 SSTIs per 100 person-years in this population and the high associated health care costs suggest that targeted interventions to prevent SSTIs "could reduce morbidity and health care resource utilization substantially," Dr. Miller concluded.

Dr. Miller disclosed financial relationships with GlaxoSmithKline, Cubist, and Pfizer. GlaxoSmithKline provided funding for this study.