Heidi Splete

WASHINGTON – Biologics use by rheumatoid arthritis patients was associated with a 25% reduction in the risk of premature death, compared with patients without exposure to biologics, based on data from a population-based study of more than 4,000 patients. The findings were presented at the annual meeting of the American College of Rheumatology.

Rheumatoid arthritis (RA) is associated with a twofold increase in premature mortality risk, primarily caused by cardiovascular disease, said Dr. Diane Lacaille of the Arthritis Research Centre of Canada, in Vancouver. Previous research suggests that the increased risk is linked to inflammation that affects other organs beyond the RA-affected joints, she said. Biologic agents have shown effectiveness in controlling the inflammation associated with joint damage in RA, but the drugs’ impact on reducing early mortality has not been well studied, Dr. Lacaille said.

Dr. Lacaille and her colleagues reviewed data from the Canadian Ministry of Health to identify all RA cases that used a biologic agent (anti–tumor necrosis factor (anti-TNF), rituximab, anakinra, or abatacept) during follow-up. The study population included 2,156 patients who used biologics and 2,156 controls matched for age, sex, and calendar year. The average age of the patients was 56 years, and 75% were women. The researchers obtained data on all health services used by the study participants – including medications, lab tests, and hospitalizations – between January 1996 and March 2006, with follow-up to March 2010.

"Exposure to biologics was associated with a reduced risk of death, with a hazard ratio of 0.26 [(95% confidence interval, 0.18-0.36), P less than or equal to .0001)], which means that the risk of death in the biologics users was a quarter that of the nonbiologic users," Dr. Lacaille said. Approximately 90% of the biologics users were using anti-TNF therapy, but the findings were consistent for all biologics in a multivariate analysis, she noted.

Overall, 573 deaths were noted during the study period, including 247 in the biologics group and 326 in the control group. The use of three previous disease-modifying antirheumatic drugs or a change in DMARD did not affect the results, Dr. Lacaille noted.

"I think it wouldn’t be accurate from an epidemiological point of view to say that biologics lead to a 75% reduction" in the risk of premature death, she said.

"But we can be confident that there was an association with a reduction in the reduced risk of death," she added.

The study was limited by the lack of randomization, which may have led to some selection bias, said Dr. Lacaille. But given the increased risk of early mortality associated with RA, the data have "important implications for health policy makers, health care providers, and people with RA," she said.

Approximately 28% of the patients had used more than one biologic, but the number or course of prior biologics had no apparent impact on the risk of death, she added.

Dr. Lacaille had no financial conflicts to disclose.

WASHINGTON – Biologics use by rheumatoid arthritis patients was associated with a 25% reduction in the risk of premature death, compared with patients without exposure to biologics, based on data from a population-based study of more than 4,000 patients. The findings were presented at the annual meeting of the American College of Rheumatology.

Rheumatoid arthritis (RA) is associated with a twofold increase in premature mortality risk, primarily caused by cardiovascular disease, said Dr. Diane Lacaille of the Arthritis Research Centre of Canada, in Vancouver. Previous research suggests that the increased risk is linked to inflammation that affects other organs beyond the RA-affected joints, she said. Biologic agents have shown effectiveness in controlling the inflammation associated with joint damage in RA, but the drugs’ impact on reducing early mortality has not been well studied, Dr. Lacaille said.

Dr. Lacaille and her colleagues reviewed data from the Canadian Ministry of Health to identify all RA cases that used a biologic agent (anti–tumor necrosis factor (anti-TNF), rituximab, anakinra, or abatacept) during follow-up. The study population included 2,156 patients who used biologics and 2,156 controls matched for age, sex, and calendar year. The average age of the patients was 56 years, and 75% were women. The researchers obtained data on all health services used by the study participants – including medications, lab tests, and hospitalizations – between January 1996 and March 2006, with follow-up to March 2010.

"Exposure to biologics was associated with a reduced risk of death, with a hazard ratio of 0.26 [(95% confidence interval, 0.18-0.36), P less than or equal to .0001)], which means that the risk of death in the biologics users was a quarter that of the nonbiologic users," Dr. Lacaille said. Approximately 90% of the biologics users were using anti-TNF therapy, but the findings were consistent for all biologics in a multivariate analysis, she noted.

Overall, 573 deaths were noted during the study period, including 247 in the biologics group and 326 in the control group. The use of three previous disease-modifying antirheumatic drugs or a change in DMARD did not affect the results, Dr. Lacaille noted.

"I think it wouldn’t be accurate from an epidemiological point of view to say that biologics lead to a 75% reduction" in the risk of premature death, she said.

"But we can be confident that there was an association with a reduction in the reduced risk of death," she added.

The study was limited by the lack of randomization, which may have led to some selection bias, said Dr. Lacaille. But given the increased risk of early mortality associated with RA, the data have "important implications for health policy makers, health care providers, and people with RA," she said.

Approximately 28% of the patients had used more than one biologic, but the number or course of prior biologics had no apparent impact on the risk of death, she added.

Dr. Lacaille had no financial conflicts to disclose.

WASHINGTON – Biologics use by rheumatoid arthritis patients was associated with a 25% reduction in the risk of premature death, compared with patients without exposure to biologics, based on data from a population-based study of more than 4,000 patients. The findings were presented at the annual meeting of the American College of Rheumatology.

Rheumatoid arthritis (RA) is associated with a twofold increase in premature mortality risk, primarily caused by cardiovascular disease, said Dr. Diane Lacaille of the Arthritis Research Centre of Canada, in Vancouver. Previous research suggests that the increased risk is linked to inflammation that affects other organs beyond the RA-affected joints, she said. Biologic agents have shown effectiveness in controlling the inflammation associated with joint damage in RA, but the drugs’ impact on reducing early mortality has not been well studied, Dr. Lacaille said.

Dr. Lacaille and her colleagues reviewed data from the Canadian Ministry of Health to identify all RA cases that used a biologic agent (anti–tumor necrosis factor (anti-TNF), rituximab, anakinra, or abatacept) during follow-up. The study population included 2,156 patients who used biologics and 2,156 controls matched for age, sex, and calendar year. The average age of the patients was 56 years, and 75% were women. The researchers obtained data on all health services used by the study participants – including medications, lab tests, and hospitalizations – between January 1996 and March 2006, with follow-up to March 2010.

"Exposure to biologics was associated with a reduced risk of death, with a hazard ratio of 0.26 [(95% confidence interval, 0.18-0.36), P less than or equal to .0001)], which means that the risk of death in the biologics users was a quarter that of the nonbiologic users," Dr. Lacaille said. Approximately 90% of the biologics users were using anti-TNF therapy, but the findings were consistent for all biologics in a multivariate analysis, she noted.

Overall, 573 deaths were noted during the study period, including 247 in the biologics group and 326 in the control group. The use of three previous disease-modifying antirheumatic drugs or a change in DMARD did not affect the results, Dr. Lacaille noted.

"I think it wouldn’t be accurate from an epidemiological point of view to say that biologics lead to a 75% reduction" in the risk of premature death, she said.

"But we can be confident that there was an association with a reduction in the reduced risk of death," she added.

The study was limited by the lack of randomization, which may have led to some selection bias, said Dr. Lacaille. But given the increased risk of early mortality associated with RA, the data have "important implications for health policy makers, health care providers, and people with RA," she said.

Approximately 28% of the patients had used more than one biologic, but the number or course of prior biologics had no apparent impact on the risk of death, she added.

Dr. Lacaille had no financial conflicts to disclose.

WASHINGTON – A daily dose of strontium ranelate was associated with a significant delay in joint space narrowing in adults with symptomatic primary knee osteoarthritis, based on data from the phase III Strontium Ranelate Knee Osteoarthritis Trial (SEKOIA).

Strontium renalate currently is not approved in the United States, but it is approved in more than 100 countries for treating osteoporosis, said Dr. Jean-Yves Reginster, who is head of the Center for Investigation in Bone and Articular Cartilage Metabolism at the University of Liège (Belgium).

Data from nonclinical studies have shown that strontium’s bone-building activity has a positive impact on cartilage as well, he noted at the annual meeting of the American College of Rheumatology.

To examine the effectiveness of strontium ranelate on the progression of knee osteoarthritis (OA), Dr. Reginster and his colleagues randomized 1,683 adults with symptomatic primary knee OA to 1 g of strontium ranelate per day (566 patients), 2 g/day (558 patients), or a placebo (559 patients). Complete data were available for 1,371 patients. The average age of the patients was 63 years, and 69% were women.

Overall, treatment with either dose of strontium was associated with a significant delay in the radiographic progression of knee OA, which was assessed by measuring the radiological joint space narrowing (JSN) of the medial tibiofemoral compartment of the knee joint.

After 1 year, joint space width decreased by 0.27 mm in the 2-g/day group, 0.23 mm in the 1-g/day group, and 0.37 mm in the placebo group. The differences between the 2-g/day and 1-g/day groups and the placebo group were 0.10 mm and 0.14 mm, respectively.

Significantly less radiological progression was noted in both strontium groups, compared with the placebo group. The percentage of patients with radiological progression (defined as joint space narrowing of at least 0.5 mm) was 26% in the 2-g/day group, 22% in the 1-g/day group, and 33% in the placebo group.

"The structural effect is translated clinically into a lower number of patients having a radiological progression over thresholds predictive of OA-related surgery," Dr. Reginster said. The findings suggest that strontium ranelate could reduce the need for knee surgery in OA patients, he added.

In addition, significantly more patients in the 2-g/day group exceeded the minimally perceptible clinical improvement (MCPI) threshold, compared with the placebo patients, on subscores of pain, stiffness, and physical function. The percentage of patients in the 1-g/day group above this threshold was not significantly higher than in the placebo group.

No significant differences in adverse events were observed among the three groups, and the incidence of serious adverse events was 17% in all groups.

The study findings also appeared online on Nov. 9 (Ann. Rheum. Dis. 2012 [doi:10.1136/annrheumdis-2012-202231]).

The study was sponsored by Servier. Dr. Reginster disclosed financial relationships with multiple companies, including Servier.

WASHINGTON – A daily dose of strontium ranelate was associated with a significant delay in joint space narrowing in adults with symptomatic primary knee osteoarthritis, based on data from the phase III Strontium Ranelate Knee Osteoarthritis Trial (SEKOIA).

Strontium renalate currently is not approved in the United States, but it is approved in more than 100 countries for treating osteoporosis, said Dr. Jean-Yves Reginster, who is head of the Center for Investigation in Bone and Articular Cartilage Metabolism at the University of Liège (Belgium).

Data from nonclinical studies have shown that strontium’s bone-building activity has a positive impact on cartilage as well, he noted at the annual meeting of the American College of Rheumatology.

To examine the effectiveness of strontium ranelate on the progression of knee osteoarthritis (OA), Dr. Reginster and his colleagues randomized 1,683 adults with symptomatic primary knee OA to 1 g of strontium ranelate per day (566 patients), 2 g/day (558 patients), or a placebo (559 patients). Complete data were available for 1,371 patients. The average age of the patients was 63 years, and 69% were women.

Overall, treatment with either dose of strontium was associated with a significant delay in the radiographic progression of knee OA, which was assessed by measuring the radiological joint space narrowing (JSN) of the medial tibiofemoral compartment of the knee joint.

After 1 year, joint space width decreased by 0.27 mm in the 2-g/day group, 0.23 mm in the 1-g/day group, and 0.37 mm in the placebo group. The differences between the 2-g/day and 1-g/day groups and the placebo group were 0.10 mm and 0.14 mm, respectively.

Significantly less radiological progression was noted in both strontium groups, compared with the placebo group. The percentage of patients with radiological progression (defined as joint space narrowing of at least 0.5 mm) was 26% in the 2-g/day group, 22% in the 1-g/day group, and 33% in the placebo group.

"The structural effect is translated clinically into a lower number of patients having a radiological progression over thresholds predictive of OA-related surgery," Dr. Reginster said. The findings suggest that strontium ranelate could reduce the need for knee surgery in OA patients, he added.

In addition, significantly more patients in the 2-g/day group exceeded the minimally perceptible clinical improvement (MCPI) threshold, compared with the placebo patients, on subscores of pain, stiffness, and physical function. The percentage of patients in the 1-g/day group above this threshold was not significantly higher than in the placebo group.

No significant differences in adverse events were observed among the three groups, and the incidence of serious adverse events was 17% in all groups.

The study findings also appeared online on Nov. 9 (Ann. Rheum. Dis. 2012 [doi:10.1136/annrheumdis-2012-202231]).

The study was sponsored by Servier. Dr. Reginster disclosed financial relationships with multiple companies, including Servier.

WASHINGTON – A daily dose of strontium ranelate was associated with a significant delay in joint space narrowing in adults with symptomatic primary knee osteoarthritis, based on data from the phase III Strontium Ranelate Knee Osteoarthritis Trial (SEKOIA).

Strontium renalate currently is not approved in the United States, but it is approved in more than 100 countries for treating osteoporosis, said Dr. Jean-Yves Reginster, who is head of the Center for Investigation in Bone and Articular Cartilage Metabolism at the University of Liège (Belgium).

Data from nonclinical studies have shown that strontium’s bone-building activity has a positive impact on cartilage as well, he noted at the annual meeting of the American College of Rheumatology.

To examine the effectiveness of strontium ranelate on the progression of knee osteoarthritis (OA), Dr. Reginster and his colleagues randomized 1,683 adults with symptomatic primary knee OA to 1 g of strontium ranelate per day (566 patients), 2 g/day (558 patients), or a placebo (559 patients). Complete data were available for 1,371 patients. The average age of the patients was 63 years, and 69% were women.

Overall, treatment with either dose of strontium was associated with a significant delay in the radiographic progression of knee OA, which was assessed by measuring the radiological joint space narrowing (JSN) of the medial tibiofemoral compartment of the knee joint.

After 1 year, joint space width decreased by 0.27 mm in the 2-g/day group, 0.23 mm in the 1-g/day group, and 0.37 mm in the placebo group. The differences between the 2-g/day and 1-g/day groups and the placebo group were 0.10 mm and 0.14 mm, respectively.

Significantly less radiological progression was noted in both strontium groups, compared with the placebo group. The percentage of patients with radiological progression (defined as joint space narrowing of at least 0.5 mm) was 26% in the 2-g/day group, 22% in the 1-g/day group, and 33% in the placebo group.

"The structural effect is translated clinically into a lower number of patients having a radiological progression over thresholds predictive of OA-related surgery," Dr. Reginster said. The findings suggest that strontium ranelate could reduce the need for knee surgery in OA patients, he added.

In addition, significantly more patients in the 2-g/day group exceeded the minimally perceptible clinical improvement (MCPI) threshold, compared with the placebo patients, on subscores of pain, stiffness, and physical function. The percentage of patients in the 1-g/day group above this threshold was not significantly higher than in the placebo group.

No significant differences in adverse events were observed among the three groups, and the incidence of serious adverse events was 17% in all groups.

The study findings also appeared online on Nov. 9 (Ann. Rheum. Dis. 2012 [doi:10.1136/annrheumdis-2012-202231]).

The study was sponsored by Servier. Dr. Reginster disclosed financial relationships with multiple companies, including Servier.

Adding the renin inhibitor aliskiren to standard hypertension treatment in type 2 diabetes patients with comorbid kidney or cardiovascular disease did not reduce serious cardiovascular or renal events, according to a multinational study of more than 8,000 patients.

The findings from ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) were presented at Kidney Week 2012 and simultaneously published online Nov. 3 in the New England Journal of Medicine.

Data from previous studies suggest that the direct renin inhibitor aliskiren, when combined with an angiotensin-receptor blocker (ARB), was associated with a greater decrease in albuminuria than ARB treatment alone in patients with diabetic renal disease, said Dr. Hans-Henrik Parving of the University of Copenhagen and his colleagues. However, the effect on renal and cardiovascular outcomes of combining aliskiren with an ARB or an angiotensin-converting–enzyme (ACE) inhibitor is unknown, they said.

To determine the safety of a dual renin–angiotensin–aldosterone system (RAAS) blockade, the researchers randomized 8,606 adults at 838 centers in 36 countries to receive standard treatment plus aliskiren or a placebo. Complete data were available for 8,561 patients enrolled between October 2007 and June 2010. Eligible patients had type 2 diabetes and were taking either an ARB or ACE inhibitor (N. Engl. J. Med. 2012, Nov. 3 [doi:10.1056/NEJMoa1208799]).

The average age of the patients was 65 years, and approximately one-third were female. Baseline demographics were similar between the two groups. After 2 months, 84% of the aliskiren patients were taking the maximum dose of 300 mg.

The primary composite outcome included death from cardiovascular causes, cardiac arrest with resuscitation, myocardial infarction (fatal or nonfatal), stroke (fatal or nonfatal), unplanned hospitalization for heart failure, end-stage renal disease (death attributable to kidney failure or loss of kidney function), and doubling of baseline serum creatinine. Any one patient "may have had multiple cardiovascular or renal events of different types," the researchers noted.

After a median follow-up of approximately 2.5 years, 783 patients in the aliskiren group (18%) and 732 in the placebo group (17%) met the primary end point, though the difference was not statistically significant (P = .12)

Aliskiren patients showed significantly lower systolic and diastolic blood pressures and higher mean reductions in urinary albumin-to-creatinine ratios after 6 months than placebo patients. However, significantly more aliskiren patients than placebo patients had hyperkalemia (39% vs. 29%, respectively) and hypotension (12% vs. 8%, respectively).

The number of deaths from any cause was not significantly different between the aliskiren and placebo groups (119 and 102, respectively).

Significantly more aliskiren patients than placebo patients discontinued the study drug due to an adverse event (13% vs. 10%). The most common adverse event was hyperkalemia, followed by renal impairment and hypotension.

"The overall lack of benefit with regard to the primary composite cardiovascular and renal outcome was observed across all the predefined subgroups," the researchers said.

Two trials of aliskiren in combination with another renin-angiotensin system blocker in heart failure patients are ongoing, the researchers said.

However, "the present study documented more adverse events in the aliskiren group than in the placebo group without clinical benefits to offset them, which underscores the need to go beyond surrogate biomarkers and obtain risk-benefit data from clinical end-point trials to better inform clinical decisions," they said.

Novartis supported the study. Dr. Parving has received funding from Novartis, served on the speakers bureau for Novartis and Sanofi, and has served as a consultant for Abbott, Reata, and Takeda.

Adding the renin inhibitor aliskiren to standard hypertension treatment in type 2 diabetes patients with comorbid kidney or cardiovascular disease did not reduce serious cardiovascular or renal events, according to a multinational study of more than 8,000 patients.

The findings from ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) were presented at Kidney Week 2012 and simultaneously published online Nov. 3 in the New England Journal of Medicine.

Data from previous studies suggest that the direct renin inhibitor aliskiren, when combined with an angiotensin-receptor blocker (ARB), was associated with a greater decrease in albuminuria than ARB treatment alone in patients with diabetic renal disease, said Dr. Hans-Henrik Parving of the University of Copenhagen and his colleagues. However, the effect on renal and cardiovascular outcomes of combining aliskiren with an ARB or an angiotensin-converting–enzyme (ACE) inhibitor is unknown, they said.

To determine the safety of a dual renin–angiotensin–aldosterone system (RAAS) blockade, the researchers randomized 8,606 adults at 838 centers in 36 countries to receive standard treatment plus aliskiren or a placebo. Complete data were available for 8,561 patients enrolled between October 2007 and June 2010. Eligible patients had type 2 diabetes and were taking either an ARB or ACE inhibitor (N. Engl. J. Med. 2012, Nov. 3 [doi:10.1056/NEJMoa1208799]).

The average age of the patients was 65 years, and approximately one-third were female. Baseline demographics were similar between the two groups. After 2 months, 84% of the aliskiren patients were taking the maximum dose of 300 mg.

The primary composite outcome included death from cardiovascular causes, cardiac arrest with resuscitation, myocardial infarction (fatal or nonfatal), stroke (fatal or nonfatal), unplanned hospitalization for heart failure, end-stage renal disease (death attributable to kidney failure or loss of kidney function), and doubling of baseline serum creatinine. Any one patient "may have had multiple cardiovascular or renal events of different types," the researchers noted.

After a median follow-up of approximately 2.5 years, 783 patients in the aliskiren group (18%) and 732 in the placebo group (17%) met the primary end point, though the difference was not statistically significant (P = .12)

Aliskiren patients showed significantly lower systolic and diastolic blood pressures and higher mean reductions in urinary albumin-to-creatinine ratios after 6 months than placebo patients. However, significantly more aliskiren patients than placebo patients had hyperkalemia (39% vs. 29%, respectively) and hypotension (12% vs. 8%, respectively).

The number of deaths from any cause was not significantly different between the aliskiren and placebo groups (119 and 102, respectively).

Significantly more aliskiren patients than placebo patients discontinued the study drug due to an adverse event (13% vs. 10%). The most common adverse event was hyperkalemia, followed by renal impairment and hypotension.

"The overall lack of benefit with regard to the primary composite cardiovascular and renal outcome was observed across all the predefined subgroups," the researchers said.

Two trials of aliskiren in combination with another renin-angiotensin system blocker in heart failure patients are ongoing, the researchers said.

However, "the present study documented more adverse events in the aliskiren group than in the placebo group without clinical benefits to offset them, which underscores the need to go beyond surrogate biomarkers and obtain risk-benefit data from clinical end-point trials to better inform clinical decisions," they said.

Novartis supported the study. Dr. Parving has received funding from Novartis, served on the speakers bureau for Novartis and Sanofi, and has served as a consultant for Abbott, Reata, and Takeda.

Adding the renin inhibitor aliskiren to standard hypertension treatment in type 2 diabetes patients with comorbid kidney or cardiovascular disease did not reduce serious cardiovascular or renal events, according to a multinational study of more than 8,000 patients.

The findings from ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) were presented at Kidney Week 2012 and simultaneously published online Nov. 3 in the New England Journal of Medicine.

Data from previous studies suggest that the direct renin inhibitor aliskiren, when combined with an angiotensin-receptor blocker (ARB), was associated with a greater decrease in albuminuria than ARB treatment alone in patients with diabetic renal disease, said Dr. Hans-Henrik Parving of the University of Copenhagen and his colleagues. However, the effect on renal and cardiovascular outcomes of combining aliskiren with an ARB or an angiotensin-converting–enzyme (ACE) inhibitor is unknown, they said.

To determine the safety of a dual renin–angiotensin–aldosterone system (RAAS) blockade, the researchers randomized 8,606 adults at 838 centers in 36 countries to receive standard treatment plus aliskiren or a placebo. Complete data were available for 8,561 patients enrolled between October 2007 and June 2010. Eligible patients had type 2 diabetes and were taking either an ARB or ACE inhibitor (N. Engl. J. Med. 2012, Nov. 3 [doi:10.1056/NEJMoa1208799]).

The average age of the patients was 65 years, and approximately one-third were female. Baseline demographics were similar between the two groups. After 2 months, 84% of the aliskiren patients were taking the maximum dose of 300 mg.

The primary composite outcome included death from cardiovascular causes, cardiac arrest with resuscitation, myocardial infarction (fatal or nonfatal), stroke (fatal or nonfatal), unplanned hospitalization for heart failure, end-stage renal disease (death attributable to kidney failure or loss of kidney function), and doubling of baseline serum creatinine. Any one patient "may have had multiple cardiovascular or renal events of different types," the researchers noted.

After a median follow-up of approximately 2.5 years, 783 patients in the aliskiren group (18%) and 732 in the placebo group (17%) met the primary end point, though the difference was not statistically significant (P = .12)

Aliskiren patients showed significantly lower systolic and diastolic blood pressures and higher mean reductions in urinary albumin-to-creatinine ratios after 6 months than placebo patients. However, significantly more aliskiren patients than placebo patients had hyperkalemia (39% vs. 29%, respectively) and hypotension (12% vs. 8%, respectively).

The number of deaths from any cause was not significantly different between the aliskiren and placebo groups (119 and 102, respectively).

Significantly more aliskiren patients than placebo patients discontinued the study drug due to an adverse event (13% vs. 10%). The most common adverse event was hyperkalemia, followed by renal impairment and hypotension.

"The overall lack of benefit with regard to the primary composite cardiovascular and renal outcome was observed across all the predefined subgroups," the researchers said.

Two trials of aliskiren in combination with another renin-angiotensin system blocker in heart failure patients are ongoing, the researchers said.

However, "the present study documented more adverse events in the aliskiren group than in the placebo group without clinical benefits to offset them, which underscores the need to go beyond surrogate biomarkers and obtain risk-benefit data from clinical end-point trials to better inform clinical decisions," they said.

Novartis supported the study. Dr. Parving has received funding from Novartis, served on the speakers bureau for Novartis and Sanofi, and has served as a consultant for Abbott, Reata, and Takeda.

A 100-mg daily dose of aspirin reduced by one-third the rate of recurrent major vascular events for patients who had one acute unprovoked venous thromboembolism and were switched from anticoagulant therapy to either aspirin or placebo after 3 months of anticoagulant therapy.*

Patients with one episode of unprovoked VTE often discontinue anticoagulant therapy due to inconvenience and the risk of bleeding, said Dr. Timothy A. Brighton of the University of Sydney, Australia, and his colleagues. For those patients, 100 mg of aspirin per day appears to be a safe alternative.

Dr. Brighton and his colleagues reported the findings based on combined data from the ASPIRE (Aspirin to Prevent Recurrent Venous Thromboembolism) study and the WARFASA (Warfarin and Aspirin) study. The findings of ASPIRE were simultaneously published in the New England Journal of Medicine and presented at the annual meeting of the American Heart Association in Los Angeles. The findings of WARFASA were previously published in the same journal.

ASPIRE examined the effect of a 100-mg daily dose of aspirin in patients who had a history of a first-ever unprovoked VTE and had completed initial anticoagulation therapy. The study population included 822 adults who were randomized to a placebo or aspirin at 56 sites in five countries from May 2003 and August 2011. Roughly half of the patients were men; 56% had a proximal deep-vein thrombosis as an index event; 29% had a pulmonary embolism as an index event, and 14% had both conditions as an index event (N. Engl. J. Med. 2012 Nov. 4 [doi: 10.1056/NEJMoa1210384]).

Overall, VTE recurred in 57 patients (14%) in the aspirin group, compared with 73 patients (18%) in the placebo group (rates of 5% and 7% per year, respectively, a nonsignificant difference).

However, the rates of two secondary composite outcomes were significantly reduced in patients who took aspirin compared with those on placebo, the researchers noted. The rate of a composite outcome including VTE, myocardial infarction, stroke, or cardiovascular death was reduced by 34% in aspirin patients (5% per year for aspirin vs. 8% per year for placebo).

The rate of a composite outcome including VTE, myocardial infarction, stroke, major bleeding, or death from any cause was reduce by 33% in aspirin patients (6% per year for aspirin vs. 9% per year for placebo).

No significant differences in serious adverse events or in the rates of major or clinically relevant nonmajor bleeding were observed between the aspirin and placebo groups, the researchers noted.

The findings were limited by the low number of patients in the study, however. The ASPIRE data alone were not adequately powered to show a significant reduction in the recurrence of VTE.

To address the issue, researchers combined the ASPIRE data with data from a similar population of 402 patients in the WARFASA (Warfarin and Aspirin) study (N. Engl. J. Med. 2012; 366:1959-67). In this multicenter, double-blind study, patients with first-ever unprovoked venous thromboembolism completed 6-18 months of oral anticoagulant treatment and were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years.

VTE recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 – 0.93). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups.

Using the combined data from both studies, the researchers found “a highly significant reduction of 32% in the rate of recurrence of venous thromboembolism and a reduction of 34% in the rate of major vascular events with no excess of bleeding.”

Therefore, the combined results of the two studies support the use of low-dose aspirin to prevent both recurrent VTE and major vascular events in patients who have had a first episode of unprovoked VTE, the researchers said.

Lead author Dr. Brighton disclosed serving as a consultant for Pfizer, GlaxoSmithKline, and other companies. The study was supported by grants from the National Health and Medical Research Council (Australia), the Health Research Council (New Zealand), the National Heart Foundation of Australia, Bayer HealthCare (Germany), and the Australasian Society of Haematology and Thrombosis

* This story was updated on 11/7/12.

A 100-mg daily dose of aspirin reduced by one-third the rate of recurrent major vascular events for patients who had one acute unprovoked venous thromboembolism and were switched from anticoagulant therapy to either aspirin or placebo after 3 months of anticoagulant therapy.*

Patients with one episode of unprovoked VTE often discontinue anticoagulant therapy due to inconvenience and the risk of bleeding, said Dr. Timothy A. Brighton of the University of Sydney, Australia, and his colleagues. For those patients, 100 mg of aspirin per day appears to be a safe alternative.

Dr. Brighton and his colleagues reported the findings based on combined data from the ASPIRE (Aspirin to Prevent Recurrent Venous Thromboembolism) study and the WARFASA (Warfarin and Aspirin) study. The findings of ASPIRE were simultaneously published in the New England Journal of Medicine and presented at the annual meeting of the American Heart Association in Los Angeles. The findings of WARFASA were previously published in the same journal.

ASPIRE examined the effect of a 100-mg daily dose of aspirin in patients who had a history of a first-ever unprovoked VTE and had completed initial anticoagulation therapy. The study population included 822 adults who were randomized to a placebo or aspirin at 56 sites in five countries from May 2003 and August 2011. Roughly half of the patients were men; 56% had a proximal deep-vein thrombosis as an index event; 29% had a pulmonary embolism as an index event, and 14% had both conditions as an index event (N. Engl. J. Med. 2012 Nov. 4 [doi: 10.1056/NEJMoa1210384]).

Overall, VTE recurred in 57 patients (14%) in the aspirin group, compared with 73 patients (18%) in the placebo group (rates of 5% and 7% per year, respectively, a nonsignificant difference).

However, the rates of two secondary composite outcomes were significantly reduced in patients who took aspirin compared with those on placebo, the researchers noted. The rate of a composite outcome including VTE, myocardial infarction, stroke, or cardiovascular death was reduced by 34% in aspirin patients (5% per year for aspirin vs. 8% per year for placebo).

The rate of a composite outcome including VTE, myocardial infarction, stroke, major bleeding, or death from any cause was reduce by 33% in aspirin patients (6% per year for aspirin vs. 9% per year for placebo).

No significant differences in serious adverse events or in the rates of major or clinically relevant nonmajor bleeding were observed between the aspirin and placebo groups, the researchers noted.

The findings were limited by the low number of patients in the study, however. The ASPIRE data alone were not adequately powered to show a significant reduction in the recurrence of VTE.

To address the issue, researchers combined the ASPIRE data with data from a similar population of 402 patients in the WARFASA (Warfarin and Aspirin) study (N. Engl. J. Med. 2012; 366:1959-67). In this multicenter, double-blind study, patients with first-ever unprovoked venous thromboembolism completed 6-18 months of oral anticoagulant treatment and were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years.

VTE recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 – 0.93). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups.

Using the combined data from both studies, the researchers found “a highly significant reduction of 32% in the rate of recurrence of venous thromboembolism and a reduction of 34% in the rate of major vascular events with no excess of bleeding.”

Therefore, the combined results of the two studies support the use of low-dose aspirin to prevent both recurrent VTE and major vascular events in patients who have had a first episode of unprovoked VTE, the researchers said.

Lead author Dr. Brighton disclosed serving as a consultant for Pfizer, GlaxoSmithKline, and other companies. The study was supported by grants from the National Health and Medical Research Council (Australia), the Health Research Council (New Zealand), the National Heart Foundation of Australia, Bayer HealthCare (Germany), and the Australasian Society of Haematology and Thrombosis

* This story was updated on 11/7/12.

A 100-mg daily dose of aspirin reduced by one-third the rate of recurrent major vascular events for patients who had one acute unprovoked venous thromboembolism and were switched from anticoagulant therapy to either aspirin or placebo after 3 months of anticoagulant therapy.*

Patients with one episode of unprovoked VTE often discontinue anticoagulant therapy due to inconvenience and the risk of bleeding, said Dr. Timothy A. Brighton of the University of Sydney, Australia, and his colleagues. For those patients, 100 mg of aspirin per day appears to be a safe alternative.

Dr. Brighton and his colleagues reported the findings based on combined data from the ASPIRE (Aspirin to Prevent Recurrent Venous Thromboembolism) study and the WARFASA (Warfarin and Aspirin) study. The findings of ASPIRE were simultaneously published in the New England Journal of Medicine and presented at the annual meeting of the American Heart Association in Los Angeles. The findings of WARFASA were previously published in the same journal.

ASPIRE examined the effect of a 100-mg daily dose of aspirin in patients who had a history of a first-ever unprovoked VTE and had completed initial anticoagulation therapy. The study population included 822 adults who were randomized to a placebo or aspirin at 56 sites in five countries from May 2003 and August 2011. Roughly half of the patients were men; 56% had a proximal deep-vein thrombosis as an index event; 29% had a pulmonary embolism as an index event, and 14% had both conditions as an index event (N. Engl. J. Med. 2012 Nov. 4 [doi: 10.1056/NEJMoa1210384]).

Overall, VTE recurred in 57 patients (14%) in the aspirin group, compared with 73 patients (18%) in the placebo group (rates of 5% and 7% per year, respectively, a nonsignificant difference).

However, the rates of two secondary composite outcomes were significantly reduced in patients who took aspirin compared with those on placebo, the researchers noted. The rate of a composite outcome including VTE, myocardial infarction, stroke, or cardiovascular death was reduced by 34% in aspirin patients (5% per year for aspirin vs. 8% per year for placebo).

The rate of a composite outcome including VTE, myocardial infarction, stroke, major bleeding, or death from any cause was reduce by 33% in aspirin patients (6% per year for aspirin vs. 9% per year for placebo).

No significant differences in serious adverse events or in the rates of major or clinically relevant nonmajor bleeding were observed between the aspirin and placebo groups, the researchers noted.

The findings were limited by the low number of patients in the study, however. The ASPIRE data alone were not adequately powered to show a significant reduction in the recurrence of VTE.

To address the issue, researchers combined the ASPIRE data with data from a similar population of 402 patients in the WARFASA (Warfarin and Aspirin) study (N. Engl. J. Med. 2012; 366:1959-67). In this multicenter, double-blind study, patients with first-ever unprovoked venous thromboembolism completed 6-18 months of oral anticoagulant treatment and were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years.

VTE recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 – 0.93). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups.

Using the combined data from both studies, the researchers found “a highly significant reduction of 32% in the rate of recurrence of venous thromboembolism and a reduction of 34% in the rate of major vascular events with no excess of bleeding.”

Therefore, the combined results of the two studies support the use of low-dose aspirin to prevent both recurrent VTE and major vascular events in patients who have had a first episode of unprovoked VTE, the researchers said.

Lead author Dr. Brighton disclosed serving as a consultant for Pfizer, GlaxoSmithKline, and other companies. The study was supported by grants from the National Health and Medical Research Council (Australia), the Health Research Council (New Zealand), the National Heart Foundation of Australia, Bayer HealthCare (Germany), and the Australasian Society of Haematology and Thrombosis

* This story was updated on 11/7/12.

Vitamin D levels above 20 ng/mL were not associated with lower mortality rates in patients with and without kidney disease; however, levels below 12 ng/mL were associated with higher mortality rates in these patients, according to the results of a study published Oct. 24 in the online journal PLoS One.

The minimal difference in mortality rates for individuals with vitamin D levels between 20 ng/mL and 30 ng/mL suggests that vitamin D supplements may not be necessary for approximately 3 million adults with chronic kidney disease and 75 million adults without kidney disease, said Dr. Holly Kramer of Loyola University Medical Center in Maywood, Ill., and her colleagues.

© Kaspri/Fotolia.com

To examine the impact of vitamin D levels on mortality, the researchers reviewed data from 15,099 adults who were part of the Third National Health and Nutrition Examination Study (NHANES III). The study population included 1,097 adults with chronic kidney disease, which was defined as an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m².

In order for mortality rates to be compared, the researchers divided the study population into groups based on vitamin D levels, ranging from less than 12 ng/mL to greater than 40 ng/mL, using the 24- to 29.9-ng/mL group as the reference group.

"This group was selected as the referent, because it includes 25[OH]D levels which are above the threshold for ‘risk of insufficiency,’ defined by the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, yet below the thresholds defined as ‘insufficient’ in previous analyses," the researchers wrote.

Overall, about one-third of the adults with kidney disease (35%) and of those without kidney disease (30%) had insufficient levels of vitamin D, based on Institute of Medicine recommendations.

The median vitamin D levels for each of the groups were 10.0 ng/mL, 14.1 ng/mL, 18.0 ng/mL, 21.9 ng/mL, 26.5 ng/mL, 33.9 ng/mL, and 43.6 ng/mL.

After the investigators controlled for risk factors including age, race, sex, smoking status, and comorbid conditions, the all-cause mortality rate was determined for the patients with kidney disease. The mortality rate was 153/1,000 person-years for those with vitamin D levels less than 12 ng/mL, 121/1,000 person-years for those in the 12- to 16-ng/mL group, and 108/1,000 person years for those in the 24- to 29.9-ng/mL range.

Mortality rates were similar for those with kidney disease and vitamin D levels greater than 20 ng/mL, the researchers noted, with the lowest mortality rate of 97/1,000 person-years seen in those in the highest vitamin D group.

Among patients without kidney disease, the adjusted all-cause mortality rate was 17/1,000 person-years among those with vitamin D levels less than 12 ng/mL, compared with 13 for those in the 24- to 29.9-ng/mL range and 12 among patients with vitamin D levels greater than 40 ng/mL.

The study was limited by its observational design, and the results may not be generalizable to nursing home residents, individuals on dialysis, or anyone who has had a kidney transplant, the researchers noted.

Vitamin D supplementation has been linked to an increased risk of cancer and kidney stones, and clinical trials are needed to assess the risks versus benefits in individuals with and without kidney disease, the researchers added.

The National Institutes of Health supported the study.

Vitamin D levels above 20 ng/mL were not associated with lower mortality rates in patients with and without kidney disease; however, levels below 12 ng/mL were associated with higher mortality rates in these patients, according to the results of a study published Oct. 24 in the online journal PLoS One.

The minimal difference in mortality rates for individuals with vitamin D levels between 20 ng/mL and 30 ng/mL suggests that vitamin D supplements may not be necessary for approximately 3 million adults with chronic kidney disease and 75 million adults without kidney disease, said Dr. Holly Kramer of Loyola University Medical Center in Maywood, Ill., and her colleagues.

© Kaspri/Fotolia.com

To examine the impact of vitamin D levels on mortality, the researchers reviewed data from 15,099 adults who were part of the Third National Health and Nutrition Examination Study (NHANES III). The study population included 1,097 adults with chronic kidney disease, which was defined as an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m².

In order for mortality rates to be compared, the researchers divided the study population into groups based on vitamin D levels, ranging from less than 12 ng/mL to greater than 40 ng/mL, using the 24- to 29.9-ng/mL group as the reference group.

"This group was selected as the referent, because it includes 25[OH]D levels which are above the threshold for ‘risk of insufficiency,’ defined by the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, yet below the thresholds defined as ‘insufficient’ in previous analyses," the researchers wrote.

Overall, about one-third of the adults with kidney disease (35%) and of those without kidney disease (30%) had insufficient levels of vitamin D, based on Institute of Medicine recommendations.

The median vitamin D levels for each of the groups were 10.0 ng/mL, 14.1 ng/mL, 18.0 ng/mL, 21.9 ng/mL, 26.5 ng/mL, 33.9 ng/mL, and 43.6 ng/mL.

After the investigators controlled for risk factors including age, race, sex, smoking status, and comorbid conditions, the all-cause mortality rate was determined for the patients with kidney disease. The mortality rate was 153/1,000 person-years for those with vitamin D levels less than 12 ng/mL, 121/1,000 person-years for those in the 12- to 16-ng/mL group, and 108/1,000 person years for those in the 24- to 29.9-ng/mL range.

Mortality rates were similar for those with kidney disease and vitamin D levels greater than 20 ng/mL, the researchers noted, with the lowest mortality rate of 97/1,000 person-years seen in those in the highest vitamin D group.

Among patients without kidney disease, the adjusted all-cause mortality rate was 17/1,000 person-years among those with vitamin D levels less than 12 ng/mL, compared with 13 for those in the 24- to 29.9-ng/mL range and 12 among patients with vitamin D levels greater than 40 ng/mL.

The study was limited by its observational design, and the results may not be generalizable to nursing home residents, individuals on dialysis, or anyone who has had a kidney transplant, the researchers noted.

Vitamin D supplementation has been linked to an increased risk of cancer and kidney stones, and clinical trials are needed to assess the risks versus benefits in individuals with and without kidney disease, the researchers added.

The National Institutes of Health supported the study.

Vitamin D levels above 20 ng/mL were not associated with lower mortality rates in patients with and without kidney disease; however, levels below 12 ng/mL were associated with higher mortality rates in these patients, according to the results of a study published Oct. 24 in the online journal PLoS One.

The minimal difference in mortality rates for individuals with vitamin D levels between 20 ng/mL and 30 ng/mL suggests that vitamin D supplements may not be necessary for approximately 3 million adults with chronic kidney disease and 75 million adults without kidney disease, said Dr. Holly Kramer of Loyola University Medical Center in Maywood, Ill., and her colleagues.

© Kaspri/Fotolia.com

To examine the impact of vitamin D levels on mortality, the researchers reviewed data from 15,099 adults who were part of the Third National Health and Nutrition Examination Study (NHANES III). The study population included 1,097 adults with chronic kidney disease, which was defined as an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m².

In order for mortality rates to be compared, the researchers divided the study population into groups based on vitamin D levels, ranging from less than 12 ng/mL to greater than 40 ng/mL, using the 24- to 29.9-ng/mL group as the reference group.

"This group was selected as the referent, because it includes 25[OH]D levels which are above the threshold for ‘risk of insufficiency,’ defined by the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, yet below the thresholds defined as ‘insufficient’ in previous analyses," the researchers wrote.

Overall, about one-third of the adults with kidney disease (35%) and of those without kidney disease (30%) had insufficient levels of vitamin D, based on Institute of Medicine recommendations.

The median vitamin D levels for each of the groups were 10.0 ng/mL, 14.1 ng/mL, 18.0 ng/mL, 21.9 ng/mL, 26.5 ng/mL, 33.9 ng/mL, and 43.6 ng/mL.

After the investigators controlled for risk factors including age, race, sex, smoking status, and comorbid conditions, the all-cause mortality rate was determined for the patients with kidney disease. The mortality rate was 153/1,000 person-years for those with vitamin D levels less than 12 ng/mL, 121/1,000 person-years for those in the 12- to 16-ng/mL group, and 108/1,000 person years for those in the 24- to 29.9-ng/mL range.

Mortality rates were similar for those with kidney disease and vitamin D levels greater than 20 ng/mL, the researchers noted, with the lowest mortality rate of 97/1,000 person-years seen in those in the highest vitamin D group.

Among patients without kidney disease, the adjusted all-cause mortality rate was 17/1,000 person-years among those with vitamin D levels less than 12 ng/mL, compared with 13 for those in the 24- to 29.9-ng/mL range and 12 among patients with vitamin D levels greater than 40 ng/mL.

The study was limited by its observational design, and the results may not be generalizable to nursing home residents, individuals on dialysis, or anyone who has had a kidney transplant, the researchers noted.

Vitamin D supplementation has been linked to an increased risk of cancer and kidney stones, and clinical trials are needed to assess the risks versus benefits in individuals with and without kidney disease, the researchers added.

The National Institutes of Health supported the study.

The overall death rate from diabetes in children aged 19 years and younger dropped by 61% from 1968 to 2009, according to data from the National Vital Statistics System. The findings were published online Nov. 1 in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

The overall death rate decrease was 78% in children younger than 10 years and 52% in those aged 10-19 years. A steady decrease occurred in children younger than 10 years from 1968 to 1995 (annual percentage change [APC] of 5.7), with a slightly slower decline from 1995 to 2009 (APC, 0.3). However, the decrease in death rates in youth aged 10-19 years from 1968 to 1984 (APC, of 6.5) was followed by an increase between 1984 and 2009 (APC, 1.6).

Photo credit: thinkstockphotos.com

"The prevalence of diabetes among youths is determined by a number of factors, including the incidence of new cases and the number of deaths among youth with diabetes," the researchers noted.

"The findings in this report that the overall death rate from diabetes has decreased among U.S. youths aged 19 years and younger might contribute to an overall increase in prevalence of diabetes among youths," they said.

Most diabetes deaths in children and teens are due to acute complications including ketoacidosis and hypoglycemia, and these conditions are preventable, the researchers said. Possible reasons for the decline in diabetes deaths include improvements in treatment, increased identification of diabetes symptoms, and better education about managing diabetes and its complications, they added.

Diabetes-related mortality was determined using data from death certificates filed in all 50 states and the District of Columbia. U.S. census data were used as denominators (MMWR 2012;61:869-72).

The study findings were limited by the lack of distinction between type 1 and type 2 diabetes in the ICD-8 or ICD-9 mortality codes reviewed, and by the lack of analysis based on race or geographic region, the researchers said.

Despite the improvement in mortality rates, "deaths resulting from diabetes in youths potentially are preventable, and these findings indicated a need for improved diabetes diagnosis and care, especially among youths aged 10-19 years, whose risk for diabetes-related mortality appears to have increased in recent years," they said.

The researchers had no financial conflicts to disclose.

The overall death rate from diabetes in children aged 19 years and younger dropped by 61% from 1968 to 2009, according to data from the National Vital Statistics System. The findings were published online Nov. 1 in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

The overall death rate decrease was 78% in children younger than 10 years and 52% in those aged 10-19 years. A steady decrease occurred in children younger than 10 years from 1968 to 1995 (annual percentage change [APC] of 5.7), with a slightly slower decline from 1995 to 2009 (APC, 0.3). However, the decrease in death rates in youth aged 10-19 years from 1968 to 1984 (APC, of 6.5) was followed by an increase between 1984 and 2009 (APC, 1.6).

Photo credit: thinkstockphotos.com

"The prevalence of diabetes among youths is determined by a number of factors, including the incidence of new cases and the number of deaths among youth with diabetes," the researchers noted.

"The findings in this report that the overall death rate from diabetes has decreased among U.S. youths aged 19 years and younger might contribute to an overall increase in prevalence of diabetes among youths," they said.

Most diabetes deaths in children and teens are due to acute complications including ketoacidosis and hypoglycemia, and these conditions are preventable, the researchers said. Possible reasons for the decline in diabetes deaths include improvements in treatment, increased identification of diabetes symptoms, and better education about managing diabetes and its complications, they added.

Diabetes-related mortality was determined using data from death certificates filed in all 50 states and the District of Columbia. U.S. census data were used as denominators (MMWR 2012;61:869-72).

The study findings were limited by the lack of distinction between type 1 and type 2 diabetes in the ICD-8 or ICD-9 mortality codes reviewed, and by the lack of analysis based on race or geographic region, the researchers said.

Despite the improvement in mortality rates, "deaths resulting from diabetes in youths potentially are preventable, and these findings indicated a need for improved diabetes diagnosis and care, especially among youths aged 10-19 years, whose risk for diabetes-related mortality appears to have increased in recent years," they said.

The researchers had no financial conflicts to disclose.

The overall death rate from diabetes in children aged 19 years and younger dropped by 61% from 1968 to 2009, according to data from the National Vital Statistics System. The findings were published online Nov. 1 in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

The overall death rate decrease was 78% in children younger than 10 years and 52% in those aged 10-19 years. A steady decrease occurred in children younger than 10 years from 1968 to 1995 (annual percentage change [APC] of 5.7), with a slightly slower decline from 1995 to 2009 (APC, 0.3). However, the decrease in death rates in youth aged 10-19 years from 1968 to 1984 (APC, of 6.5) was followed by an increase between 1984 and 2009 (APC, 1.6).

Photo credit: thinkstockphotos.com

"The prevalence of diabetes among youths is determined by a number of factors, including the incidence of new cases and the number of deaths among youth with diabetes," the researchers noted.

"The findings in this report that the overall death rate from diabetes has decreased among U.S. youths aged 19 years and younger might contribute to an overall increase in prevalence of diabetes among youths," they said.

Most diabetes deaths in children and teens are due to acute complications including ketoacidosis and hypoglycemia, and these conditions are preventable, the researchers said. Possible reasons for the decline in diabetes deaths include improvements in treatment, increased identification of diabetes symptoms, and better education about managing diabetes and its complications, they added.

Diabetes-related mortality was determined using data from death certificates filed in all 50 states and the District of Columbia. U.S. census data were used as denominators (MMWR 2012;61:869-72).

The study findings were limited by the lack of distinction between type 1 and type 2 diabetes in the ICD-8 or ICD-9 mortality codes reviewed, and by the lack of analysis based on race or geographic region, the researchers said.

Despite the improvement in mortality rates, "deaths resulting from diabetes in youths potentially are preventable, and these findings indicated a need for improved diabetes diagnosis and care, especially among youths aged 10-19 years, whose risk for diabetes-related mortality appears to have increased in recent years," they said.

The researchers had no financial conflicts to disclose.

CHICAGO – Surgical patients receiving care at the least complex hospitals had a 50% increased risk of death compared with those treated at more complex hospitals, based on data from more than 400,000 patients.

Data from previous research suggest that the characteristics of individual hospitals predict surgical outcomes, but the relationship between hospital complexity and surgical mortality has not been well studied, Dr. Marta McCrum said at the annual clinical congress of the American College of Surgeons.

She and her colleagues reviewed Medicare administrative claims data from 2008-2009 and information on hospital characteristics from the American Hospital Association Survey 2009 on 2,695 hospitals. The hospitals were divided into quintiles based on complexity, which for purposes of this study was defined as the number of unique diagnoses and procedures performed at each facility.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals."

"Hospitals that see a wide variety of conditions (common problems but also very rare or complicated diagnoses) would be equipped with the wide range of services and resources needed to support them – that is, they would be complex. Similarly, hospitals that perform the widest range of unique procedures would also have the greatest diversity of services and technology," Dr. McCrum of Harvard University, Boston, explained in an interview.

"We therefore ranked the hospitals separately based on the number of unique diagnoses and procedures they saw, and then summed the ranks to assign a numeric value to the complexity of that hospital in comparison to the others. For the analysis, we separated the hospitals into quintiles based on this value."

Not surprisingly, low-complexity hospitals tended to be smaller, more rural, and located in lower-income areas, and the more complex hospitals tended to be larger, urban, and in higher-income areas, she said.

"Of note, the surgical mortality rate of the highest-complexity hospitals was 7.3%, versus 12.6% at the lowest-complexity hospitals," for an absolute risk reduction of 5.3%, she said.

The researchers controlled for hospital and population characteristics, including total number of hospital discharges, public/private ownership, percentage of Medicare patients, urban location, and county income. Hospital complexity remained a significant predictor of mortality between each quintile compared with the highest-complexity quintile.

"The average aggregate mortality rate at the lowest-complexity hospitals is 46% higher than that of the highest-complexity hospitals," said Dr. McCrum.

Overall, the research model explained 28% of the variability in mortality rates, and within the model, hospital complexity explained the greatest proportion of variability in mortality rates. Although hospital volume was a statistically significant predictor of mortality, the effect was small, she noted.

The study was limited by the fact that approximately two-thirds of the variability remained unexplained, likely due to a combination of patient factors and hospital factors, she said. Additional limitations included the lack of an existing metric to measure hospital complexity, and the limitations of using administrative claims data.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals," Dr. McCrum said in an interview. "This might be due in part to the expanded capabilities and systems of care present at these centers. By identifying these lifesaving elements that are cultivated in complex centers, and making them available in lower-complexity hospitals, we can ensure that all surgical procedures take place in facilities with the appropriate systems to support them," she said.

Dr. McCrum had no financial conflicts to disclose.

CHICAGO – Surgical patients receiving care at the least complex hospitals had a 50% increased risk of death compared with those treated at more complex hospitals, based on data from more than 400,000 patients.

Data from previous research suggest that the characteristics of individual hospitals predict surgical outcomes, but the relationship between hospital complexity and surgical mortality has not been well studied, Dr. Marta McCrum said at the annual clinical congress of the American College of Surgeons.

She and her colleagues reviewed Medicare administrative claims data from 2008-2009 and information on hospital characteristics from the American Hospital Association Survey 2009 on 2,695 hospitals. The hospitals were divided into quintiles based on complexity, which for purposes of this study was defined as the number of unique diagnoses and procedures performed at each facility.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals."

"Hospitals that see a wide variety of conditions (common problems but also very rare or complicated diagnoses) would be equipped with the wide range of services and resources needed to support them – that is, they would be complex. Similarly, hospitals that perform the widest range of unique procedures would also have the greatest diversity of services and technology," Dr. McCrum of Harvard University, Boston, explained in an interview.

"We therefore ranked the hospitals separately based on the number of unique diagnoses and procedures they saw, and then summed the ranks to assign a numeric value to the complexity of that hospital in comparison to the others. For the analysis, we separated the hospitals into quintiles based on this value."

Not surprisingly, low-complexity hospitals tended to be smaller, more rural, and located in lower-income areas, and the more complex hospitals tended to be larger, urban, and in higher-income areas, she said.

"Of note, the surgical mortality rate of the highest-complexity hospitals was 7.3%, versus 12.6% at the lowest-complexity hospitals," for an absolute risk reduction of 5.3%, she said.

The researchers controlled for hospital and population characteristics, including total number of hospital discharges, public/private ownership, percentage of Medicare patients, urban location, and county income. Hospital complexity remained a significant predictor of mortality between each quintile compared with the highest-complexity quintile.

"The average aggregate mortality rate at the lowest-complexity hospitals is 46% higher than that of the highest-complexity hospitals," said Dr. McCrum.

Overall, the research model explained 28% of the variability in mortality rates, and within the model, hospital complexity explained the greatest proportion of variability in mortality rates. Although hospital volume was a statistically significant predictor of mortality, the effect was small, she noted.

The study was limited by the fact that approximately two-thirds of the variability remained unexplained, likely due to a combination of patient factors and hospital factors, she said. Additional limitations included the lack of an existing metric to measure hospital complexity, and the limitations of using administrative claims data.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals," Dr. McCrum said in an interview. "This might be due in part to the expanded capabilities and systems of care present at these centers. By identifying these lifesaving elements that are cultivated in complex centers, and making them available in lower-complexity hospitals, we can ensure that all surgical procedures take place in facilities with the appropriate systems to support them," she said.

Dr. McCrum had no financial conflicts to disclose.

CHICAGO – Surgical patients receiving care at the least complex hospitals had a 50% increased risk of death compared with those treated at more complex hospitals, based on data from more than 400,000 patients.

Data from previous research suggest that the characteristics of individual hospitals predict surgical outcomes, but the relationship between hospital complexity and surgical mortality has not been well studied, Dr. Marta McCrum said at the annual clinical congress of the American College of Surgeons.

She and her colleagues reviewed Medicare administrative claims data from 2008-2009 and information on hospital characteristics from the American Hospital Association Survey 2009 on 2,695 hospitals. The hospitals were divided into quintiles based on complexity, which for purposes of this study was defined as the number of unique diagnoses and procedures performed at each facility.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals."

"Hospitals that see a wide variety of conditions (common problems but also very rare or complicated diagnoses) would be equipped with the wide range of services and resources needed to support them – that is, they would be complex. Similarly, hospitals that perform the widest range of unique procedures would also have the greatest diversity of services and technology," Dr. McCrum of Harvard University, Boston, explained in an interview.

"We therefore ranked the hospitals separately based on the number of unique diagnoses and procedures they saw, and then summed the ranks to assign a numeric value to the complexity of that hospital in comparison to the others. For the analysis, we separated the hospitals into quintiles based on this value."

Not surprisingly, low-complexity hospitals tended to be smaller, more rural, and located in lower-income areas, and the more complex hospitals tended to be larger, urban, and in higher-income areas, she said.

"Of note, the surgical mortality rate of the highest-complexity hospitals was 7.3%, versus 12.6% at the lowest-complexity hospitals," for an absolute risk reduction of 5.3%, she said.

The researchers controlled for hospital and population characteristics, including total number of hospital discharges, public/private ownership, percentage of Medicare patients, urban location, and county income. Hospital complexity remained a significant predictor of mortality between each quintile compared with the highest-complexity quintile.

"The average aggregate mortality rate at the lowest-complexity hospitals is 46% higher than that of the highest-complexity hospitals," said Dr. McCrum.

Overall, the research model explained 28% of the variability in mortality rates, and within the model, hospital complexity explained the greatest proportion of variability in mortality rates. Although hospital volume was a statistically significant predictor of mortality, the effect was small, she noted.

The study was limited by the fact that approximately two-thirds of the variability remained unexplained, likely due to a combination of patient factors and hospital factors, she said. Additional limitations included the lack of an existing metric to measure hospital complexity, and the limitations of using administrative claims data.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals," Dr. McCrum said in an interview. "This might be due in part to the expanded capabilities and systems of care present at these centers. By identifying these lifesaving elements that are cultivated in complex centers, and making them available in lower-complexity hospitals, we can ensure that all surgical procedures take place in facilities with the appropriate systems to support them," she said.

Dr. McCrum had no financial conflicts to disclose.

Adults who take aspirin daily have a 15% reduced risk of death from cancer compared with controls, and a 37% reduced risk of cancer death after 5 years, based on data from 51 randomized trials of daily aspirin use vs. no aspirin.

Findings from previous studies have suggested a cancer-prevention role for aspirin, but long-term data were limited and incomplete, said Dr. Peter Rothwell of the University of Oxford (England), and his colleagues.

The researchers reviewed data from the Antithrombotic Trialists’ Collaboration, PubMed, and Embase. They included only trials of daily aspirin vs. no aspirin.

Overall, randomization to aspirin significantly reduced the risk of nonvascular death in patients in the 51 trials compared with no aspirin (1,021 vs. 1,173, respectively, P = .003).

In a review of cancer deaths from 34 of the 51 studies, aspirin was associated with significantly fewer cancer deaths compared with controls (562 vs. 664, P = .008). The benefit was most evident in patients in trials lasting 5 years or longer, the researchers said (Lancet 2012;379:1602-12).

In terms of primary prevention, daily aspirin use significantly reduced the risk of a composite outcome of major vascular events, cancer, or fatal extracranial bleeds (P = .0002), the researchers noted.

The findings were limited by the focus only on daily aspirin use, and by the use of composite outcomes, the researchers said.

However, the results suggest that aspirin reduces cancer incidence and mortality, they noted.

"In view of the very low rates of vascular events in recent and ongoing trials of aspirin in primary prevention, prevention of cancer could become the main justification for aspirin use in this setting, although more research is required to identify which individuals are likely to benefit most," they said.

The study should be considered in the context of two additional studies by Dr. Rothwell and his colleagues, one published online in the Lancet, and the other published online in the Lancet Oncology, the researchers added.

In the additional Lancet study, a review of five large, randomized trials of daily aspirin of at least 75 mg versus controls, daily aspirin significantly reduced the risk of cancer metastases by 30%-40% in the short term.

These findings may explain the early reduction in cancer risk associated with aspirin that was observed in the primary prevention trials, and the results "are likely to underestimate the true effects of aspirin," the researchers noted (Lancet 2012 [doi: 10.1016/S0140-6736(12)60209-8]).

In the Lancet Oncology, a review of case-control studies, cohort studies, and randomized trials of aspirin use showed significant reductions in the risk of colo- rectal cancer, as well as significant reductions in the risk of esophageal, gastric, biliary, and breast cancer. The greatest impact was on the reduction in risk of gastrointestinal cancers (Lancet Oncol. 2012 [doi: 10.1016/S1470-2045(12)70112-2]).

Both of these additional studies support the role of aspirin in reducing cancer deaths.

The studies were independent of company funding. Dr. Rothwell has received honoraria for talks, advisory board participation, and clinical trial committee participation from multiple companies, including AstraZeneca, Bayer, Boehringer Ingelheim, Sanofi-Aventis/Bristol-Myers Squibb, and Servier, and is on the executive committee of the ARRIVE trial.

Adults who take aspirin daily have a 15% reduced risk of death from cancer compared with controls, and a 37% reduced risk of cancer death after 5 years, based on data from 51 randomized trials of daily aspirin use vs. no aspirin.

Findings from previous studies have suggested a cancer-prevention role for aspirin, but long-term data were limited and incomplete, said Dr. Peter Rothwell of the University of Oxford (England), and his colleagues.

The researchers reviewed data from the Antithrombotic Trialists’ Collaboration, PubMed, and Embase. They included only trials of daily aspirin vs. no aspirin.

Overall, randomization to aspirin significantly reduced the risk of nonvascular death in patients in the 51 trials compared with no aspirin (1,021 vs. 1,173, respectively, P = .003).

In a review of cancer deaths from 34 of the 51 studies, aspirin was associated with significantly fewer cancer deaths compared with controls (562 vs. 664, P = .008). The benefit was most evident in patients in trials lasting 5 years or longer, the researchers said (Lancet 2012;379:1602-12).

In terms of primary prevention, daily aspirin use significantly reduced the risk of a composite outcome of major vascular events, cancer, or fatal extracranial bleeds (P = .0002), the researchers noted.

The findings were limited by the focus only on daily aspirin use, and by the use of composite outcomes, the researchers said.

However, the results suggest that aspirin reduces cancer incidence and mortality, they noted.

"In view of the very low rates of vascular events in recent and ongoing trials of aspirin in primary prevention, prevention of cancer could become the main justification for aspirin use in this setting, although more research is required to identify which individuals are likely to benefit most," they said.

The study should be considered in the context of two additional studies by Dr. Rothwell and his colleagues, one published online in the Lancet, and the other published online in the Lancet Oncology, the researchers added.

In the additional Lancet study, a review of five large, randomized trials of daily aspirin of at least 75 mg versus controls, daily aspirin significantly reduced the risk of cancer metastases by 30%-40% in the short term.

These findings may explain the early reduction in cancer risk associated with aspirin that was observed in the primary prevention trials, and the results "are likely to underestimate the true effects of aspirin," the researchers noted (Lancet 2012 [doi: 10.1016/S0140-6736(12)60209-8]).

In the Lancet Oncology, a review of case-control studies, cohort studies, and randomized trials of aspirin use showed significant reductions in the risk of colo- rectal cancer, as well as significant reductions in the risk of esophageal, gastric, biliary, and breast cancer. The greatest impact was on the reduction in risk of gastrointestinal cancers (Lancet Oncol. 2012 [doi: 10.1016/S1470-2045(12)70112-2]).

Both of these additional studies support the role of aspirin in reducing cancer deaths.

The studies were independent of company funding. Dr. Rothwell has received honoraria for talks, advisory board participation, and clinical trial committee participation from multiple companies, including AstraZeneca, Bayer, Boehringer Ingelheim, Sanofi-Aventis/Bristol-Myers Squibb, and Servier, and is on the executive committee of the ARRIVE trial.

Adults who take aspirin daily have a 15% reduced risk of death from cancer compared with controls, and a 37% reduced risk of cancer death after 5 years, based on data from 51 randomized trials of daily aspirin use vs. no aspirin.

Findings from previous studies have suggested a cancer-prevention role for aspirin, but long-term data were limited and incomplete, said Dr. Peter Rothwell of the University of Oxford (England), and his colleagues.

The researchers reviewed data from the Antithrombotic Trialists’ Collaboration, PubMed, and Embase. They included only trials of daily aspirin vs. no aspirin.

Overall, randomization to aspirin significantly reduced the risk of nonvascular death in patients in the 51 trials compared with no aspirin (1,021 vs. 1,173, respectively, P = .003).

In a review of cancer deaths from 34 of the 51 studies, aspirin was associated with significantly fewer cancer deaths compared with controls (562 vs. 664, P = .008). The benefit was most evident in patients in trials lasting 5 years or longer, the researchers said (Lancet 2012;379:1602-12).

In terms of primary prevention, daily aspirin use significantly reduced the risk of a composite outcome of major vascular events, cancer, or fatal extracranial bleeds (P = .0002), the researchers noted.

The findings were limited by the focus only on daily aspirin use, and by the use of composite outcomes, the researchers said.

However, the results suggest that aspirin reduces cancer incidence and mortality, they noted.

"In view of the very low rates of vascular events in recent and ongoing trials of aspirin in primary prevention, prevention of cancer could become the main justification for aspirin use in this setting, although more research is required to identify which individuals are likely to benefit most," they said.

The study should be considered in the context of two additional studies by Dr. Rothwell and his colleagues, one published online in the Lancet, and the other published online in the Lancet Oncology, the researchers added.

In the additional Lancet study, a review of five large, randomized trials of daily aspirin of at least 75 mg versus controls, daily aspirin significantly reduced the risk of cancer metastases by 30%-40% in the short term.

These findings may explain the early reduction in cancer risk associated with aspirin that was observed in the primary prevention trials, and the results "are likely to underestimate the true effects of aspirin," the researchers noted (Lancet 2012 [doi: 10.1016/S0140-6736(12)60209-8]).

In the Lancet Oncology, a review of case-control studies, cohort studies, and randomized trials of aspirin use showed significant reductions in the risk of colo- rectal cancer, as well as significant reductions in the risk of esophageal, gastric, biliary, and breast cancer. The greatest impact was on the reduction in risk of gastrointestinal cancers (Lancet Oncol. 2012 [doi: 10.1016/S1470-2045(12)70112-2]).

Both of these additional studies support the role of aspirin in reducing cancer deaths.

The studies were independent of company funding. Dr. Rothwell has received honoraria for talks, advisory board participation, and clinical trial committee participation from multiple companies, including AstraZeneca, Bayer, Boehringer Ingelheim, Sanofi-Aventis/Bristol-Myers Squibb, and Servier, and is on the executive committee of the ARRIVE trial.

CHICAGO – Laparoscopic ultrasound was as effective as transabdominal ultrasound for detecting cholelithiasis, and superior at finding gallbladder polyps, based on data from 253 adults undergoing laparoscopic gastric bypass procedures.

Morbidly obese patients are at increased risk for cholelithiasis, with approximately 22%-52% developing the condition, said Dr. Kosisochi M. Obinwanne at the annual clinical congress of the American College of Surgeons.

For surgeons who perform gallbladder surgery separate from the gastric bypass, "it becomes necessary to obtain images of the gallbladder to determine the presence of gallstones," said Dr. Obinwanne of Gundersen Lutheran Health System in La Crosse, Wisc.

"Transabdominal ultrasound is the gold standard for detecting cholelithiasis," he said. However, the increased visceral and subcutaneous fat in patients with morbid obesity can make detection of gallbladder pathology difficult using transabdominal ultrasound (TAU), but laparoscopic ultrasound (LU) has the potential to be as effective as TAU, he noted.

To evaluate the sensitivity and specificity of LU vs. TAU for detecting gallbladder pathology in morbidly obese patients, Dr. Obinwanne and his colleagues conducted a prospective study of 253 patients who underwent laparoscopic gastric bypass over a 6-year period. Their average age was 43 years, average body mass index was 48 kg/m², and 76% were women.

The patients underwent both TAU and LU during laparoscopic gastric bypass surgery. Certified ultrasonographers performed TAU, and surgeons blinded to the TAU results performed LU, Dr. Obinwanne said.

Overall, LU and TAU identified cholelithiasis in 60 and 61 patients, respectively, said Dr. Obinwanne. The average common bile duct diameter measurement was 3.7 mm with LU and 4.0 mm with TAU.

However, LU found significantly more gallbladder polyps than did TAU (41 vs. 6). The sensitivity and specificity of LU were 90% and 98%, respectively, for gallbladder pathology and 83% and 85%, respectively, for polyps.

"The mean time to complete an LU procedure was 4 minutes," Dr. Obinwanne said.

The study was limited by its small size, but the results suggest that LU is safe, quick, and easy to perform – and thus it’s an alternative to TAU for detecting gallbladder pathology in bariatric surgery patients.

Dr. Obinwanne had no financial conflicts to disclose.

CHICAGO – Laparoscopic ultrasound was as effective as transabdominal ultrasound for detecting cholelithiasis, and superior at finding gallbladder polyps, based on data from 253 adults undergoing laparoscopic gastric bypass procedures.

Morbidly obese patients are at increased risk for cholelithiasis, with approximately 22%-52% developing the condition, said Dr. Kosisochi M. Obinwanne at the annual clinical congress of the American College of Surgeons.

For surgeons who perform gallbladder surgery separate from the gastric bypass, "it becomes necessary to obtain images of the gallbladder to determine the presence of gallstones," said Dr. Obinwanne of Gundersen Lutheran Health System in La Crosse, Wisc.

"Transabdominal ultrasound is the gold standard for detecting cholelithiasis," he said. However, the increased visceral and subcutaneous fat in patients with morbid obesity can make detection of gallbladder pathology difficult using transabdominal ultrasound (TAU), but laparoscopic ultrasound (LU) has the potential to be as effective as TAU, he noted.

To evaluate the sensitivity and specificity of LU vs. TAU for detecting gallbladder pathology in morbidly obese patients, Dr. Obinwanne and his colleagues conducted a prospective study of 253 patients who underwent laparoscopic gastric bypass over a 6-year period. Their average age was 43 years, average body mass index was 48 kg/m², and 76% were women.

The patients underwent both TAU and LU during laparoscopic gastric bypass surgery. Certified ultrasonographers performed TAU, and surgeons blinded to the TAU results performed LU, Dr. Obinwanne said.

Overall, LU and TAU identified cholelithiasis in 60 and 61 patients, respectively, said Dr. Obinwanne. The average common bile duct diameter measurement was 3.7 mm with LU and 4.0 mm with TAU.

However, LU found significantly more gallbladder polyps than did TAU (41 vs. 6). The sensitivity and specificity of LU were 90% and 98%, respectively, for gallbladder pathology and 83% and 85%, respectively, for polyps.

"The mean time to complete an LU procedure was 4 minutes," Dr. Obinwanne said.

The study was limited by its small size, but the results suggest that LU is safe, quick, and easy to perform – and thus it’s an alternative to TAU for detecting gallbladder pathology in bariatric surgery patients.

Dr. Obinwanne had no financial conflicts to disclose.

CHICAGO – Laparoscopic ultrasound was as effective as transabdominal ultrasound for detecting cholelithiasis, and superior at finding gallbladder polyps, based on data from 253 adults undergoing laparoscopic gastric bypass procedures.

Morbidly obese patients are at increased risk for cholelithiasis, with approximately 22%-52% developing the condition, said Dr. Kosisochi M. Obinwanne at the annual clinical congress of the American College of Surgeons.

For surgeons who perform gallbladder surgery separate from the gastric bypass, "it becomes necessary to obtain images of the gallbladder to determine the presence of gallstones," said Dr. Obinwanne of Gundersen Lutheran Health System in La Crosse, Wisc.

"Transabdominal ultrasound is the gold standard for detecting cholelithiasis," he said. However, the increased visceral and subcutaneous fat in patients with morbid obesity can make detection of gallbladder pathology difficult using transabdominal ultrasound (TAU), but laparoscopic ultrasound (LU) has the potential to be as effective as TAU, he noted.

To evaluate the sensitivity and specificity of LU vs. TAU for detecting gallbladder pathology in morbidly obese patients, Dr. Obinwanne and his colleagues conducted a prospective study of 253 patients who underwent laparoscopic gastric bypass over a 6-year period. Their average age was 43 years, average body mass index was 48 kg/m², and 76% were women.

The patients underwent both TAU and LU during laparoscopic gastric bypass surgery. Certified ultrasonographers performed TAU, and surgeons blinded to the TAU results performed LU, Dr. Obinwanne said.

Overall, LU and TAU identified cholelithiasis in 60 and 61 patients, respectively, said Dr. Obinwanne. The average common bile duct diameter measurement was 3.7 mm with LU and 4.0 mm with TAU.

However, LU found significantly more gallbladder polyps than did TAU (41 vs. 6). The sensitivity and specificity of LU were 90% and 98%, respectively, for gallbladder pathology and 83% and 85%, respectively, for polyps.

"The mean time to complete an LU procedure was 4 minutes," Dr. Obinwanne said.

The study was limited by its small size, but the results suggest that LU is safe, quick, and easy to perform – and thus it’s an alternative to TAU for detecting gallbladder pathology in bariatric surgery patients.

Dr. Obinwanne had no financial conflicts to disclose.

CHICAGO – A majority of unplanned 30-day readmissions of general surgery patients to a pediatric hospital resulted from the initial surgery or procedure for which the child was hospitalized, according to data on more than 300 patients. The findings were presented at the annual clinical congress of the American College of Surgeons.

Hospital readmission within 30 days has become an important quality measure, but data on the frequency and epidemiology of pediatric surgery readmissions are limited, said Dr. Andre Marshall of Vanderbilt University, Nashville, Tenn.

"In order to decrease readmissions, pediatric surgeons must know where to focus efforts," he said.

To determine the proportion of readmissions associated with each surgical service, Dr. Marshall and colleagues reviewed data from 12,438 surgical admissions at a single center between January 2007 and December 2010. Data were taken from the Pediatric Health Information System database and electronic medical records.

A 30-day readmission was defined as any readmission within 30 days of an index hospitalization. Surgical services included general surgery, thoracic surgery, neurosurgery, cardiac surgery, orthopedics, otolaryngology, urologic surgery, ophthalmology, plastic surgery, and kidney and liver transplants.

In all, 1,178 patients were readmitted during the study period, for a readmission rate of 10%. Of these, 318 (27%) were general surgery readmissions. The next highest readmission rates by specialty were neurosurgery (26%), cardiac surgery (18%), and orthopedics (10%). The average age of the readmitted patients was 3 years, and 58% were male.

Of the 318 general surgery readmissions, 295 were unplanned, Dr. Marshall said. Of these, 174 (59%) were related to the index surgery or procedure, and 121 (41%) were related to a new illness, new trauma, or other reason not related to the initial procedure.

Among general surgery patients, infection complications were the most common reason for 30-day readmission (38%), followed by gastrointestinal issues (28%), respiratory complications (9%), planned readmissions (7%), postoperative pain (5%), and other (13%).

The most common preoperative diagnoses associated with 30-day readmission were acute appendicitis (18%), congenital malformations (17%), and gastroesophageal reflux disease (14%).

"Improving processes to anticipate which patients and diagnoses are at the greatest risk of 30-day readmission will potentially allow for early interventions by providers," Dr. Marshall said. Early intervention will allow clinicians to implement strategies to help reduce overall readmission rates and improve the quality of patient care, he added.

Dr. Marshall had no financial conflicts to disclose.

CHICAGO – A majority of unplanned 30-day readmissions of general surgery patients to a pediatric hospital resulted from the initial surgery or procedure for which the child was hospitalized, according to data on more than 300 patients. The findings were presented at the annual clinical congress of the American College of Surgeons.

Hospital readmission within 30 days has become an important quality measure, but data on the frequency and epidemiology of pediatric surgery readmissions are limited, said Dr. Andre Marshall of Vanderbilt University, Nashville, Tenn.

"In order to decrease readmissions, pediatric surgeons must know where to focus efforts," he said.

To determine the proportion of readmissions associated with each surgical service, Dr. Marshall and colleagues reviewed data from 12,438 surgical admissions at a single center between January 2007 and December 2010. Data were taken from the Pediatric Health Information System database and electronic medical records.

A 30-day readmission was defined as any readmission within 30 days of an index hospitalization. Surgical services included general surgery, thoracic surgery, neurosurgery, cardiac surgery, orthopedics, otolaryngology, urologic surgery, ophthalmology, plastic surgery, and kidney and liver transplants.

In all, 1,178 patients were readmitted during the study period, for a readmission rate of 10%. Of these, 318 (27%) were general surgery readmissions. The next highest readmission rates by specialty were neurosurgery (26%), cardiac surgery (18%), and orthopedics (10%). The average age of the readmitted patients was 3 years, and 58% were male.

Of the 318 general surgery readmissions, 295 were unplanned, Dr. Marshall said. Of these, 174 (59%) were related to the index surgery or procedure, and 121 (41%) were related to a new illness, new trauma, or other reason not related to the initial procedure.

Among general surgery patients, infection complications were the most common reason for 30-day readmission (38%), followed by gastrointestinal issues (28%), respiratory complications (9%), planned readmissions (7%), postoperative pain (5%), and other (13%).

The most common preoperative diagnoses associated with 30-day readmission were acute appendicitis (18%), congenital malformations (17%), and gastroesophageal reflux disease (14%).

"Improving processes to anticipate which patients and diagnoses are at the greatest risk of 30-day readmission will potentially allow for early interventions by providers," Dr. Marshall said. Early intervention will allow clinicians to implement strategies to help reduce overall readmission rates and improve the quality of patient care, he added.

Dr. Marshall had no financial conflicts to disclose.

CHICAGO – A majority of unplanned 30-day readmissions of general surgery patients to a pediatric hospital resulted from the initial surgery or procedure for which the child was hospitalized, according to data on more than 300 patients. The findings were presented at the annual clinical congress of the American College of Surgeons.

Hospital readmission within 30 days has become an important quality measure, but data on the frequency and epidemiology of pediatric surgery readmissions are limited, said Dr. Andre Marshall of Vanderbilt University, Nashville, Tenn.

"In order to decrease readmissions, pediatric surgeons must know where to focus efforts," he said.

To determine the proportion of readmissions associated with each surgical service, Dr. Marshall and colleagues reviewed data from 12,438 surgical admissions at a single center between January 2007 and December 2010. Data were taken from the Pediatric Health Information System database and electronic medical records.

A 30-day readmission was defined as any readmission within 30 days of an index hospitalization. Surgical services included general surgery, thoracic surgery, neurosurgery, cardiac surgery, orthopedics, otolaryngology, urologic surgery, ophthalmology, plastic surgery, and kidney and liver transplants.

In all, 1,178 patients were readmitted during the study period, for a readmission rate of 10%. Of these, 318 (27%) were general surgery readmissions. The next highest readmission rates by specialty were neurosurgery (26%), cardiac surgery (18%), and orthopedics (10%). The average age of the readmitted patients was 3 years, and 58% were male.

Of the 318 general surgery readmissions, 295 were unplanned, Dr. Marshall said. Of these, 174 (59%) were related to the index surgery or procedure, and 121 (41%) were related to a new illness, new trauma, or other reason not related to the initial procedure.

Among general surgery patients, infection complications were the most common reason for 30-day readmission (38%), followed by gastrointestinal issues (28%), respiratory complications (9%), planned readmissions (7%), postoperative pain (5%), and other (13%).

The most common preoperative diagnoses associated with 30-day readmission were acute appendicitis (18%), congenital malformations (17%), and gastroesophageal reflux disease (14%).

"Improving processes to anticipate which patients and diagnoses are at the greatest risk of 30-day readmission will potentially allow for early interventions by providers," Dr. Marshall said. Early intervention will allow clinicians to implement strategies to help reduce overall readmission rates and improve the quality of patient care, he added.

Dr. Marshall had no financial conflicts to disclose.