Heidi Splete

Ranbaxy Inc. voluntarily recalled 41 lots of Atorvastatin calcium tablets in 10-mg, 20-mg, and 40-mg doses because of potential contamination with ground glass, the company and the Food and Drug Administration announced Nov. 28.

The small size of the particles (less than 1 mm) makes safety concerns unlikely, according to the statement from MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

"However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out," according to the statement.

The recall does not affect the 80-mg dosage of Atorvastatin calcium tablets, according to the Ranbaxy company press release, which lists the specific lots included in the recall.

Ranbaxy initiated the recall on Nov. 9. Distributors have ceased distribution of the affected lots and are in the process of returning these products to Ranbaxy, according to the statement. The affected tablet is white in color, with the imprint RX12 on 10-mg tablets, RX828 on 20-mg tablets, and RX829 on 40-mg tablets.

Atorvastatin is prescribed not only for lowering blood cholesterol, but also for the prevention of cardiovascular disease in patients at high risk for cardiovascular conditions, and for the prevention of cardiovascular events in patients with heart disease.

Adverse reactions or quality problems with the affected atorvastatin lots may be reported to the FDA online, by mail (use Form FDA 3500), or by fax (1-800-FDA-0178).

Ranbaxy Inc. voluntarily recalled 41 lots of Atorvastatin calcium tablets in 10-mg, 20-mg, and 40-mg doses because of potential contamination with ground glass, the company and the Food and Drug Administration announced Nov. 28.

The small size of the particles (less than 1 mm) makes safety concerns unlikely, according to the statement from MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

"However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out," according to the statement.

The recall does not affect the 80-mg dosage of Atorvastatin calcium tablets, according to the Ranbaxy company press release, which lists the specific lots included in the recall.

Ranbaxy initiated the recall on Nov. 9. Distributors have ceased distribution of the affected lots and are in the process of returning these products to Ranbaxy, according to the statement. The affected tablet is white in color, with the imprint RX12 on 10-mg tablets, RX828 on 20-mg tablets, and RX829 on 40-mg tablets.

Atorvastatin is prescribed not only for lowering blood cholesterol, but also for the prevention of cardiovascular disease in patients at high risk for cardiovascular conditions, and for the prevention of cardiovascular events in patients with heart disease.

Adverse reactions or quality problems with the affected atorvastatin lots may be reported to the FDA online, by mail (use Form FDA 3500), or by fax (1-800-FDA-0178).

Ranbaxy Inc. voluntarily recalled 41 lots of Atorvastatin calcium tablets in 10-mg, 20-mg, and 40-mg doses because of potential contamination with ground glass, the company and the Food and Drug Administration announced Nov. 28.

The small size of the particles (less than 1 mm) makes safety concerns unlikely, according to the statement from MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

"However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out," according to the statement.

The recall does not affect the 80-mg dosage of Atorvastatin calcium tablets, according to the Ranbaxy company press release, which lists the specific lots included in the recall.

Ranbaxy initiated the recall on Nov. 9. Distributors have ceased distribution of the affected lots and are in the process of returning these products to Ranbaxy, according to the statement. The affected tablet is white in color, with the imprint RX12 on 10-mg tablets, RX828 on 20-mg tablets, and RX829 on 40-mg tablets.

Atorvastatin is prescribed not only for lowering blood cholesterol, but also for the prevention of cardiovascular disease in patients at high risk for cardiovascular conditions, and for the prevention of cardiovascular events in patients with heart disease.

Adverse reactions or quality problems with the affected atorvastatin lots may be reported to the FDA online, by mail (use Form FDA 3500), or by fax (1-800-FDA-0178).

Approximately 1 in 4 new HIV infections in the United States in 2010 occurred in youth aged 13-24 years, according to data from the Centers for Disease Control and Prevention.

Nearly two-thirds (60%) of infected youth are unaware of their condition, according to a study published online Nov. 27 in Morbidity and Mortality Weekly Report.

"The bottom line is that every month, 1,000 youth are becoming infected with HIV," CDC director Dr. Thomas Frieden said in a telebriefing. "The cost of care of a single patient is approximately $400,000 over their lifetime," he said. "That means every month we are accruing about 400 million dollars of health care costs from preventable infections in youth."

Amanda Mills/CDC

"Reducing HIV among young people is a top priority for CDC," said Dr. Frieden. "This is about the health of a new generation, and protecting them from an entirely preventable disease."

In 2010, youth aged 13-24 years accounted for 12,200 new cases of HIV, which was 26% of the total estimated 45,700 new HIV infections. Of these 12,200, approximately 8,000 (72%) occurred in young men who have sex with men (MSM). Approximately 57% of the new cases among young MSM occurred in black youth, compared with 20% among both white and Hispanic youth, he noted.

An estimated 7,000 (57%) newly infected youths were black, 2,390 (20%) were Hispanic, and 2,380 (20%) were white. The report did not account for the ethnicity of the remaining 3% of the cohort. The majority of the newly infected youth were male (83%).

Although the CDC currently recommends routine HIV testing in medical settings, only 13% of high school students, 22% of sexually active high school students, and 35% of young adults aged 18-34 years have been tested, according to the report (MMWR 2012;61:1-6).

The researchers also reviewed data on risky behaviors among high school students in 12 states and 9 large urban school districts. Overall, young MSM were significantly less likely than their heterosexual peers to have used a condom during their most recent sexual encounters (44% vs. 70%), significantly more likely to have had four or more sexual partners (39% vs. 27%), and significantly less likely to report learning about HIV or AIDS in school (75% vs. 86%).

"We know there are many young people who are not routinely seeing health care providers," Dr. Frieden said. However, health care providers have a role to play in preventing the spread of HIV.

"The key for clinicians is to make it [HIV testing] routine," said Dr. Frieden. "Just as we screen adults for high cholesterol, we screen people for HIV infection. If someone refuses testing, that is their right," he said, but clinicians can have a policy of "this is what we do."

CDC researchers used data from the National HIV Surveillance System to estimate the incidence of new HIV infections in 2010. Data from the 2010 National Health Interview Survey and the Youth Risk Behavior Surveillance System were used to assess risk factors and testing rates.

The study was supported by the Centers for Disease Control and Prevention.

Approximately 1 in 4 new HIV infections in the United States in 2010 occurred in youth aged 13-24 years, according to data from the Centers for Disease Control and Prevention.

Nearly two-thirds (60%) of infected youth are unaware of their condition, according to a study published online Nov. 27 in Morbidity and Mortality Weekly Report.

"The bottom line is that every month, 1,000 youth are becoming infected with HIV," CDC director Dr. Thomas Frieden said in a telebriefing. "The cost of care of a single patient is approximately $400,000 over their lifetime," he said. "That means every month we are accruing about 400 million dollars of health care costs from preventable infections in youth."

Amanda Mills/CDC

"Reducing HIV among young people is a top priority for CDC," said Dr. Frieden. "This is about the health of a new generation, and protecting them from an entirely preventable disease."

In 2010, youth aged 13-24 years accounted for 12,200 new cases of HIV, which was 26% of the total estimated 45,700 new HIV infections. Of these 12,200, approximately 8,000 (72%) occurred in young men who have sex with men (MSM). Approximately 57% of the new cases among young MSM occurred in black youth, compared with 20% among both white and Hispanic youth, he noted.

An estimated 7,000 (57%) newly infected youths were black, 2,390 (20%) were Hispanic, and 2,380 (20%) were white. The report did not account for the ethnicity of the remaining 3% of the cohort. The majority of the newly infected youth were male (83%).

Although the CDC currently recommends routine HIV testing in medical settings, only 13% of high school students, 22% of sexually active high school students, and 35% of young adults aged 18-34 years have been tested, according to the report (MMWR 2012;61:1-6).

The researchers also reviewed data on risky behaviors among high school students in 12 states and 9 large urban school districts. Overall, young MSM were significantly less likely than their heterosexual peers to have used a condom during their most recent sexual encounters (44% vs. 70%), significantly more likely to have had four or more sexual partners (39% vs. 27%), and significantly less likely to report learning about HIV or AIDS in school (75% vs. 86%).

"We know there are many young people who are not routinely seeing health care providers," Dr. Frieden said. However, health care providers have a role to play in preventing the spread of HIV.

"The key for clinicians is to make it [HIV testing] routine," said Dr. Frieden. "Just as we screen adults for high cholesterol, we screen people for HIV infection. If someone refuses testing, that is their right," he said, but clinicians can have a policy of "this is what we do."

CDC researchers used data from the National HIV Surveillance System to estimate the incidence of new HIV infections in 2010. Data from the 2010 National Health Interview Survey and the Youth Risk Behavior Surveillance System were used to assess risk factors and testing rates.

The study was supported by the Centers for Disease Control and Prevention.

Approximately 1 in 4 new HIV infections in the United States in 2010 occurred in youth aged 13-24 years, according to data from the Centers for Disease Control and Prevention.

Nearly two-thirds (60%) of infected youth are unaware of their condition, according to a study published online Nov. 27 in Morbidity and Mortality Weekly Report.

"The bottom line is that every month, 1,000 youth are becoming infected with HIV," CDC director Dr. Thomas Frieden said in a telebriefing. "The cost of care of a single patient is approximately $400,000 over their lifetime," he said. "That means every month we are accruing about 400 million dollars of health care costs from preventable infections in youth."

Amanda Mills/CDC

"Reducing HIV among young people is a top priority for CDC," said Dr. Frieden. "This is about the health of a new generation, and protecting them from an entirely preventable disease."

In 2010, youth aged 13-24 years accounted for 12,200 new cases of HIV, which was 26% of the total estimated 45,700 new HIV infections. Of these 12,200, approximately 8,000 (72%) occurred in young men who have sex with men (MSM). Approximately 57% of the new cases among young MSM occurred in black youth, compared with 20% among both white and Hispanic youth, he noted.

An estimated 7,000 (57%) newly infected youths were black, 2,390 (20%) were Hispanic, and 2,380 (20%) were white. The report did not account for the ethnicity of the remaining 3% of the cohort. The majority of the newly infected youth were male (83%).

Although the CDC currently recommends routine HIV testing in medical settings, only 13% of high school students, 22% of sexually active high school students, and 35% of young adults aged 18-34 years have been tested, according to the report (MMWR 2012;61:1-6).

The researchers also reviewed data on risky behaviors among high school students in 12 states and 9 large urban school districts. Overall, young MSM were significantly less likely than their heterosexual peers to have used a condom during their most recent sexual encounters (44% vs. 70%), significantly more likely to have had four or more sexual partners (39% vs. 27%), and significantly less likely to report learning about HIV or AIDS in school (75% vs. 86%).

"We know there are many young people who are not routinely seeing health care providers," Dr. Frieden said. However, health care providers have a role to play in preventing the spread of HIV.

"The key for clinicians is to make it [HIV testing] routine," said Dr. Frieden. "Just as we screen adults for high cholesterol, we screen people for HIV infection. If someone refuses testing, that is their right," he said, but clinicians can have a policy of "this is what we do."

CDC researchers used data from the National HIV Surveillance System to estimate the incidence of new HIV infections in 2010. Data from the 2010 National Health Interview Survey and the Youth Risk Behavior Surveillance System were used to assess risk factors and testing rates.

The study was supported by the Centers for Disease Control and Prevention.

WASHINGTON – Younger age, lower baseline pain, and shorter time to remission were significant predictors of sustained remission for early rheumatoid arthritis patients, based on data from more than 1,000 patients older than 16 years.

The prevalence of and predictive factors for sustained remission in early rheumatoid arthritis (RA) is not well understood, "particularly in the context of new stringent definitions," said Dr. Vivian P. Bykerk, who is on the staff of the Inflammatory Arthritis Center of the Hospital for Special Surgery in New York.

Dr. Bykerk and her colleagues reviewed data from the Canadian Early Arthritis Cohort (CATCH) study. Their selected study population included 1,244 adults with probable or confirmed RA. The average age of the patients was 54 years, 83% were white, and 73% were women. The researchers presented the data at the annual American College of Rheumatology meeting.

Remission was defined using the Simple Disease Activity Index (SDAI) and the ACR/EULAR clinical practice and clinical trial definitions. The remission definition using SDAI was a score of 3.3 or less. The ACR/EULAR clinical practice remission definition included a tender joint count, swollen joint count, and patient global assessment scores of 1 or less; the clinical trial definition added a CRP level of 1 mg/dL or less to the clinical practice definition.

Overall, 40% of the patients achieved SDAI remission, 42% achieved ACR/EULAR clinical practice remission, and 35% achieved ACR/EULAR clinical trial remission. The median time to remission based on the three definitions was 10 months, 8 months, and 9 months, respectively.

Of the patients who achieved SDAI, ACR/EULAR clinical practice, and ACR/EULAR clinical trial remission, 56%, 59%, and 54%, respectively, achieved sustained remission (defined as remission lasting at least 12 months).

The average duration of symptoms was 6 months. Patients were either treatment naïve or in the early stages of treatment. In the first 3 months, 44% of the patients received combination therapy, 32% received methotrexate monotherapy, 30% received oral corticosteroids, and 2% received biologics.

The average SDAI score at baseline was 29, and the baseline number of tender and swollen joints was approximately 8. Patients were evaluated every 3 months for the first year, followed by evaluations every 6 months.

After researchers adjusted for confounding variables, they determined that younger age, lower baseline pain score, and shorter time to remission were significantly associated with sustained remission. The effect of shorter time to remission on sustained remission supports striving for early remission in early RA patients, Dr. Bykerk noted.

Variables that were not associated with sustained remission included smoking status, symptom duration, tender or swollen joint counts, morning stiffness, and initial treatment with oral corticosteroids or biologics.

Methotrexate monotherapy was associated with lower sustained remission, and the data could not prove an association between combination disease-modifying antirheumatic drugs (DMARD) therapy and sustained remission, said Dr. Bykerk.

In addition, laboratory values for erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, and anticitrullinated protein antibodies (ACPA) were not associated with sustained remission, she said.

The study findings were limited by several factors including a lack of data on medication changes and the limited follow-up times of 3- and 6-month intervals, Dr. Bykerk said. But the results are strengthened by the use of a real-world observational cohort and suggest that more work is needed to determine the best patient-specific treatment strategies, she said.

Dr. Bykerk disclosed financial relationships with multiple companies including Abbott, Amgen, Pfizer, and Roche.

WASHINGTON – Younger age, lower baseline pain, and shorter time to remission were significant predictors of sustained remission for early rheumatoid arthritis patients, based on data from more than 1,000 patients older than 16 years.

The prevalence of and predictive factors for sustained remission in early rheumatoid arthritis (RA) is not well understood, "particularly in the context of new stringent definitions," said Dr. Vivian P. Bykerk, who is on the staff of the Inflammatory Arthritis Center of the Hospital for Special Surgery in New York.

Dr. Bykerk and her colleagues reviewed data from the Canadian Early Arthritis Cohort (CATCH) study. Their selected study population included 1,244 adults with probable or confirmed RA. The average age of the patients was 54 years, 83% were white, and 73% were women. The researchers presented the data at the annual American College of Rheumatology meeting.

Remission was defined using the Simple Disease Activity Index (SDAI) and the ACR/EULAR clinical practice and clinical trial definitions. The remission definition using SDAI was a score of 3.3 or less. The ACR/EULAR clinical practice remission definition included a tender joint count, swollen joint count, and patient global assessment scores of 1 or less; the clinical trial definition added a CRP level of 1 mg/dL or less to the clinical practice definition.

Overall, 40% of the patients achieved SDAI remission, 42% achieved ACR/EULAR clinical practice remission, and 35% achieved ACR/EULAR clinical trial remission. The median time to remission based on the three definitions was 10 months, 8 months, and 9 months, respectively.

Of the patients who achieved SDAI, ACR/EULAR clinical practice, and ACR/EULAR clinical trial remission, 56%, 59%, and 54%, respectively, achieved sustained remission (defined as remission lasting at least 12 months).

The average duration of symptoms was 6 months. Patients were either treatment naïve or in the early stages of treatment. In the first 3 months, 44% of the patients received combination therapy, 32% received methotrexate monotherapy, 30% received oral corticosteroids, and 2% received biologics.

The average SDAI score at baseline was 29, and the baseline number of tender and swollen joints was approximately 8. Patients were evaluated every 3 months for the first year, followed by evaluations every 6 months.

After researchers adjusted for confounding variables, they determined that younger age, lower baseline pain score, and shorter time to remission were significantly associated with sustained remission. The effect of shorter time to remission on sustained remission supports striving for early remission in early RA patients, Dr. Bykerk noted.

Variables that were not associated with sustained remission included smoking status, symptom duration, tender or swollen joint counts, morning stiffness, and initial treatment with oral corticosteroids or biologics.

Methotrexate monotherapy was associated with lower sustained remission, and the data could not prove an association between combination disease-modifying antirheumatic drugs (DMARD) therapy and sustained remission, said Dr. Bykerk.

In addition, laboratory values for erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, and anticitrullinated protein antibodies (ACPA) were not associated with sustained remission, she said.

The study findings were limited by several factors including a lack of data on medication changes and the limited follow-up times of 3- and 6-month intervals, Dr. Bykerk said. But the results are strengthened by the use of a real-world observational cohort and suggest that more work is needed to determine the best patient-specific treatment strategies, she said.

Dr. Bykerk disclosed financial relationships with multiple companies including Abbott, Amgen, Pfizer, and Roche.

WASHINGTON – Younger age, lower baseline pain, and shorter time to remission were significant predictors of sustained remission for early rheumatoid arthritis patients, based on data from more than 1,000 patients older than 16 years.

The prevalence of and predictive factors for sustained remission in early rheumatoid arthritis (RA) is not well understood, "particularly in the context of new stringent definitions," said Dr. Vivian P. Bykerk, who is on the staff of the Inflammatory Arthritis Center of the Hospital for Special Surgery in New York.

Dr. Bykerk and her colleagues reviewed data from the Canadian Early Arthritis Cohort (CATCH) study. Their selected study population included 1,244 adults with probable or confirmed RA. The average age of the patients was 54 years, 83% were white, and 73% were women. The researchers presented the data at the annual American College of Rheumatology meeting.

Remission was defined using the Simple Disease Activity Index (SDAI) and the ACR/EULAR clinical practice and clinical trial definitions. The remission definition using SDAI was a score of 3.3 or less. The ACR/EULAR clinical practice remission definition included a tender joint count, swollen joint count, and patient global assessment scores of 1 or less; the clinical trial definition added a CRP level of 1 mg/dL or less to the clinical practice definition.

Overall, 40% of the patients achieved SDAI remission, 42% achieved ACR/EULAR clinical practice remission, and 35% achieved ACR/EULAR clinical trial remission. The median time to remission based on the three definitions was 10 months, 8 months, and 9 months, respectively.

Of the patients who achieved SDAI, ACR/EULAR clinical practice, and ACR/EULAR clinical trial remission, 56%, 59%, and 54%, respectively, achieved sustained remission (defined as remission lasting at least 12 months).

The average duration of symptoms was 6 months. Patients were either treatment naïve or in the early stages of treatment. In the first 3 months, 44% of the patients received combination therapy, 32% received methotrexate monotherapy, 30% received oral corticosteroids, and 2% received biologics.

The average SDAI score at baseline was 29, and the baseline number of tender and swollen joints was approximately 8. Patients were evaluated every 3 months for the first year, followed by evaluations every 6 months.

After researchers adjusted for confounding variables, they determined that younger age, lower baseline pain score, and shorter time to remission were significantly associated with sustained remission. The effect of shorter time to remission on sustained remission supports striving for early remission in early RA patients, Dr. Bykerk noted.

Variables that were not associated with sustained remission included smoking status, symptom duration, tender or swollen joint counts, morning stiffness, and initial treatment with oral corticosteroids or biologics.

Methotrexate monotherapy was associated with lower sustained remission, and the data could not prove an association between combination disease-modifying antirheumatic drugs (DMARD) therapy and sustained remission, said Dr. Bykerk.

In addition, laboratory values for erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, and anticitrullinated protein antibodies (ACPA) were not associated with sustained remission, she said.

The study findings were limited by several factors including a lack of data on medication changes and the limited follow-up times of 3- and 6-month intervals, Dr. Bykerk said. But the results are strengthened by the use of a real-world observational cohort and suggest that more work is needed to determine the best patient-specific treatment strategies, she said.

Dr. Bykerk disclosed financial relationships with multiple companies including Abbott, Amgen, Pfizer, and Roche.

CHICAGO – Approximately one-third of surgical complications were diagnosed after patients left the hospital, based on data from nearly 60,000 procedures performed at 112 hospitals.

Reporting postoperative complications, including surgical site infections, has become a mandatory quality reporting initiative for hospitals, and the Affordable Care Act requires reporting of readmissions, said Dr. Melanie Morris of the University of Alabama at Birmingham.

"Some postoperative complications may lead to readmissions, but this may not tell the whole story," she noted at the annual clinical congress of the American College of Surgeons.

To determine the timing of postoperative complications and the nature of readmissions, Dr. Morris and her colleagues reviewed Veterans Affairs data from the noncardiac Surgical Care Improvement Project (SCIP) cohort from 2005 to 2009 for 59,464 surgical procedures in which there was at least one complication.

Surgical cases were classified by specialty into gastrointestinal, gynecologic, orthopedic, and vascular. Complications were grouped into organ-based systems. For example, urinary complications included renal failure, renal insufficiency, and urinary tract infections; respiratory complications included failure to wean, pneumonia, and reintubation; and surgical site infections (SSIs) included both deep and superficial wounds.

The overall complication rate was approximately 15%, and 32% of complications were diagnosed after hospital discharge, Dr. Morris said. More than half (56%) of all SSIs were diagnosed after discharge, she added.

A statistically significant difference appeared in postdischarge complications by surgical specialty. The SSI rate was 5.4%, followed by respiratory complications (5.0%), urinary tract infection (4.9%), cardiac complications (3.2%), and venous thromboembolism (1.2%).

"Our GI surgical patients had the highest overall complication rate," Dr. Morris noted. Among GI patients, colectomy patients had the highest SSI rate (11%), and 23% of the GI complications were diagnosed after hospital discharge.

In addition, 78% of SSIs in orthopedic patients were diagnosed after discharge, as were 39% of SSIs in GI patients, 77% of SSIs in vascular surgery patients, and 95% of SSIs in gynecologic patients, said Dr. Morris.

There were no significant differences in length of hospital stay based on complications, Dr. Morris said.

The overall readmission rate was 11.9%, and 70% of these patients had no identifiable postoperative complication. Of those who did have an identifiable postop complication, 72% were diagnosed before discharge from the hospital.

The probability of being readmitted to the hospital over time was highest in patients with a postdischarge diagnosis of a complication. The overall length of stay was 5 days, and the average length of stay for patients with any complication was 9 days.

Patient-specific factors associated with an increased risk of readmission included a history of heart failure, renal failure, diabetes, weight loss, and smoking. Procedure-specific factors associated with an increased risk of readmission included a longer operating time, a more contaminated wound, and a higher ASA (American Society of Anesthesiologists) class.

Length of stay was slightly protective for readmission, and the presence of any complication was associated with a high risk of readmission.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge," said Dr. Morris.

"Postoperative complications must be measured beyond hospital discharge to capture the whole story.

"Systematic collection of postoperative complications must include postdischarge data as well as readmissions to accurately measure quality," she said.

Dr. Morris said she had no relevant financial disclosures.

CHICAGO – Approximately one-third of surgical complications were diagnosed after patients left the hospital, based on data from nearly 60,000 procedures performed at 112 hospitals.

Reporting postoperative complications, including surgical site infections, has become a mandatory quality reporting initiative for hospitals, and the Affordable Care Act requires reporting of readmissions, said Dr. Melanie Morris of the University of Alabama at Birmingham.

"Some postoperative complications may lead to readmissions, but this may not tell the whole story," she noted at the annual clinical congress of the American College of Surgeons.

To determine the timing of postoperative complications and the nature of readmissions, Dr. Morris and her colleagues reviewed Veterans Affairs data from the noncardiac Surgical Care Improvement Project (SCIP) cohort from 2005 to 2009 for 59,464 surgical procedures in which there was at least one complication.

Surgical cases were classified by specialty into gastrointestinal, gynecologic, orthopedic, and vascular. Complications were grouped into organ-based systems. For example, urinary complications included renal failure, renal insufficiency, and urinary tract infections; respiratory complications included failure to wean, pneumonia, and reintubation; and surgical site infections (SSIs) included both deep and superficial wounds.

The overall complication rate was approximately 15%, and 32% of complications were diagnosed after hospital discharge, Dr. Morris said. More than half (56%) of all SSIs were diagnosed after discharge, she added.

A statistically significant difference appeared in postdischarge complications by surgical specialty. The SSI rate was 5.4%, followed by respiratory complications (5.0%), urinary tract infection (4.9%), cardiac complications (3.2%), and venous thromboembolism (1.2%).

"Our GI surgical patients had the highest overall complication rate," Dr. Morris noted. Among GI patients, colectomy patients had the highest SSI rate (11%), and 23% of the GI complications were diagnosed after hospital discharge.

In addition, 78% of SSIs in orthopedic patients were diagnosed after discharge, as were 39% of SSIs in GI patients, 77% of SSIs in vascular surgery patients, and 95% of SSIs in gynecologic patients, said Dr. Morris.

There were no significant differences in length of hospital stay based on complications, Dr. Morris said.

The overall readmission rate was 11.9%, and 70% of these patients had no identifiable postoperative complication. Of those who did have an identifiable postop complication, 72% were diagnosed before discharge from the hospital.

The probability of being readmitted to the hospital over time was highest in patients with a postdischarge diagnosis of a complication. The overall length of stay was 5 days, and the average length of stay for patients with any complication was 9 days.

Patient-specific factors associated with an increased risk of readmission included a history of heart failure, renal failure, diabetes, weight loss, and smoking. Procedure-specific factors associated with an increased risk of readmission included a longer operating time, a more contaminated wound, and a higher ASA (American Society of Anesthesiologists) class.

Length of stay was slightly protective for readmission, and the presence of any complication was associated with a high risk of readmission.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge," said Dr. Morris.

"Postoperative complications must be measured beyond hospital discharge to capture the whole story.

"Systematic collection of postoperative complications must include postdischarge data as well as readmissions to accurately measure quality," she said.

Dr. Morris said she had no relevant financial disclosures.

CHICAGO – Approximately one-third of surgical complications were diagnosed after patients left the hospital, based on data from nearly 60,000 procedures performed at 112 hospitals.

Reporting postoperative complications, including surgical site infections, has become a mandatory quality reporting initiative for hospitals, and the Affordable Care Act requires reporting of readmissions, said Dr. Melanie Morris of the University of Alabama at Birmingham.

"Some postoperative complications may lead to readmissions, but this may not tell the whole story," she noted at the annual clinical congress of the American College of Surgeons.

To determine the timing of postoperative complications and the nature of readmissions, Dr. Morris and her colleagues reviewed Veterans Affairs data from the noncardiac Surgical Care Improvement Project (SCIP) cohort from 2005 to 2009 for 59,464 surgical procedures in which there was at least one complication.

Surgical cases were classified by specialty into gastrointestinal, gynecologic, orthopedic, and vascular. Complications were grouped into organ-based systems. For example, urinary complications included renal failure, renal insufficiency, and urinary tract infections; respiratory complications included failure to wean, pneumonia, and reintubation; and surgical site infections (SSIs) included both deep and superficial wounds.

The overall complication rate was approximately 15%, and 32% of complications were diagnosed after hospital discharge, Dr. Morris said. More than half (56%) of all SSIs were diagnosed after discharge, she added.

A statistically significant difference appeared in postdischarge complications by surgical specialty. The SSI rate was 5.4%, followed by respiratory complications (5.0%), urinary tract infection (4.9%), cardiac complications (3.2%), and venous thromboembolism (1.2%).

"Our GI surgical patients had the highest overall complication rate," Dr. Morris noted. Among GI patients, colectomy patients had the highest SSI rate (11%), and 23% of the GI complications were diagnosed after hospital discharge.

In addition, 78% of SSIs in orthopedic patients were diagnosed after discharge, as were 39% of SSIs in GI patients, 77% of SSIs in vascular surgery patients, and 95% of SSIs in gynecologic patients, said Dr. Morris.

There were no significant differences in length of hospital stay based on complications, Dr. Morris said.

The overall readmission rate was 11.9%, and 70% of these patients had no identifiable postoperative complication. Of those who did have an identifiable postop complication, 72% were diagnosed before discharge from the hospital.

The probability of being readmitted to the hospital over time was highest in patients with a postdischarge diagnosis of a complication. The overall length of stay was 5 days, and the average length of stay for patients with any complication was 9 days.

Patient-specific factors associated with an increased risk of readmission included a history of heart failure, renal failure, diabetes, weight loss, and smoking. Procedure-specific factors associated with an increased risk of readmission included a longer operating time, a more contaminated wound, and a higher ASA (American Society of Anesthesiologists) class.

Length of stay was slightly protective for readmission, and the presence of any complication was associated with a high risk of readmission.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge," said Dr. Morris.

"Postoperative complications must be measured beyond hospital discharge to capture the whole story.

"Systematic collection of postoperative complications must include postdischarge data as well as readmissions to accurately measure quality," she said.

Dr. Morris said she had no relevant financial disclosures.

WASHINGTON – Men with rheumatoid arthritis who have depression or depressive symptoms were significantly more likely to die compared with RA patients who were not depressed, according to data from a longitudinal cohort study of 530 patients. The findings were presented at the annual meeting of the American College of Rheumatology.

The deleterious effect of depression on early mortality also was seen in women with RA, but to a lesser extent.

"Depression is often underdiagnosed in RA," but the risk of mortality associated with depression in RA has not been well studied, said Patricia Katz, Ph.D., of the University of California, San Francisco.

Dr. Katz and colleagues conducted annual telephone surveys of 530 adults with RA over a 7-year period, with an average of 5 years’ follow-up. The average age of the patients was 60 years, 84% were women, the average disease duration was 19 years, and 46% reported at least one cardiovascular risk factor. Depression was defined as a score of 5 or higher on the 15-item Geriatric Depression Scale (GDS).

"Even though depression is very common in RA, it is not normal."

A total of 63 patients (12%) died during the study period. The risk of death in depressed men and women with RA was approximately three times that of RA patients who were not depressed (hazard ratio 3.5), according to the results of a bivariate analysis.

"People who were depressed at their last interview were more likely to die," Dr. Katz said. In a multivariate analysis, depression remained a significant predictor of mortality.

In particular, men with RA who met criteria for depression had the highest risk of mortality.

"Overall, men were two and half times more likely to die than women," Dr. Katz said, but men with depression had a risk that was six times higher than women with no depression (who served as a reference group), she added. Women with depression had a risk of death of two and half times that of women with no depression.

In addition, a change in depressive symptoms that did not meet the criteria for depression (defined as a worsening of GDS scores by at least 2 points) was associated with an approximately twofold increased risk of death in depressed women compared to women with no depression. Men with an increase in depressive symptom scores had an increase in risk five times that of women with no depression.

"Both depression and an increase in depressive symptoms are significant risk factors for all-cause mortality in RA," Dr. Katz noted.

"I think it is important to recognize that depression is a treatable condition," said Dr. Katz. "Even though depression is very common in RA, it is not normal. It needs to be treated, and to be treated it needs to be recognized," she said.

"This is the clinical challenge; there needs to be some sort of regular monitoring to recognize these changes early, so intervention can happen at an appropriate time," she added.

The study was funded in part by the National Institute for Arthritis, Musculoskeletal, and Skin Diseases of the National Institutes of Health. Dr. Katz had no financial conflicts to disclose.

WASHINGTON – Men with rheumatoid arthritis who have depression or depressive symptoms were significantly more likely to die compared with RA patients who were not depressed, according to data from a longitudinal cohort study of 530 patients. The findings were presented at the annual meeting of the American College of Rheumatology.

The deleterious effect of depression on early mortality also was seen in women with RA, but to a lesser extent.

"Depression is often underdiagnosed in RA," but the risk of mortality associated with depression in RA has not been well studied, said Patricia Katz, Ph.D., of the University of California, San Francisco.

Dr. Katz and colleagues conducted annual telephone surveys of 530 adults with RA over a 7-year period, with an average of 5 years’ follow-up. The average age of the patients was 60 years, 84% were women, the average disease duration was 19 years, and 46% reported at least one cardiovascular risk factor. Depression was defined as a score of 5 or higher on the 15-item Geriatric Depression Scale (GDS).

"Even though depression is very common in RA, it is not normal."

A total of 63 patients (12%) died during the study period. The risk of death in depressed men and women with RA was approximately three times that of RA patients who were not depressed (hazard ratio 3.5), according to the results of a bivariate analysis.

"People who were depressed at their last interview were more likely to die," Dr. Katz said. In a multivariate analysis, depression remained a significant predictor of mortality.

In particular, men with RA who met criteria for depression had the highest risk of mortality.

"Overall, men were two and half times more likely to die than women," Dr. Katz said, but men with depression had a risk that was six times higher than women with no depression (who served as a reference group), she added. Women with depression had a risk of death of two and half times that of women with no depression.

In addition, a change in depressive symptoms that did not meet the criteria for depression (defined as a worsening of GDS scores by at least 2 points) was associated with an approximately twofold increased risk of death in depressed women compared to women with no depression. Men with an increase in depressive symptom scores had an increase in risk five times that of women with no depression.

"Both depression and an increase in depressive symptoms are significant risk factors for all-cause mortality in RA," Dr. Katz noted.

"I think it is important to recognize that depression is a treatable condition," said Dr. Katz. "Even though depression is very common in RA, it is not normal. It needs to be treated, and to be treated it needs to be recognized," she said.

"This is the clinical challenge; there needs to be some sort of regular monitoring to recognize these changes early, so intervention can happen at an appropriate time," she added.

The study was funded in part by the National Institute for Arthritis, Musculoskeletal, and Skin Diseases of the National Institutes of Health. Dr. Katz had no financial conflicts to disclose.

WASHINGTON – Men with rheumatoid arthritis who have depression or depressive symptoms were significantly more likely to die compared with RA patients who were not depressed, according to data from a longitudinal cohort study of 530 patients. The findings were presented at the annual meeting of the American College of Rheumatology.

The deleterious effect of depression on early mortality also was seen in women with RA, but to a lesser extent.

"Depression is often underdiagnosed in RA," but the risk of mortality associated with depression in RA has not been well studied, said Patricia Katz, Ph.D., of the University of California, San Francisco.

Dr. Katz and colleagues conducted annual telephone surveys of 530 adults with RA over a 7-year period, with an average of 5 years’ follow-up. The average age of the patients was 60 years, 84% were women, the average disease duration was 19 years, and 46% reported at least one cardiovascular risk factor. Depression was defined as a score of 5 or higher on the 15-item Geriatric Depression Scale (GDS).

"Even though depression is very common in RA, it is not normal."

A total of 63 patients (12%) died during the study period. The risk of death in depressed men and women with RA was approximately three times that of RA patients who were not depressed (hazard ratio 3.5), according to the results of a bivariate analysis.

"People who were depressed at their last interview were more likely to die," Dr. Katz said. In a multivariate analysis, depression remained a significant predictor of mortality.

In particular, men with RA who met criteria for depression had the highest risk of mortality.

"Overall, men were two and half times more likely to die than women," Dr. Katz said, but men with depression had a risk that was six times higher than women with no depression (who served as a reference group), she added. Women with depression had a risk of death of two and half times that of women with no depression.

In addition, a change in depressive symptoms that did not meet the criteria for depression (defined as a worsening of GDS scores by at least 2 points) was associated with an approximately twofold increased risk of death in depressed women compared to women with no depression. Men with an increase in depressive symptom scores had an increase in risk five times that of women with no depression.

"Both depression and an increase in depressive symptoms are significant risk factors for all-cause mortality in RA," Dr. Katz noted.

"I think it is important to recognize that depression is a treatable condition," said Dr. Katz. "Even though depression is very common in RA, it is not normal. It needs to be treated, and to be treated it needs to be recognized," she said.

"This is the clinical challenge; there needs to be some sort of regular monitoring to recognize these changes early, so intervention can happen at an appropriate time," she added.

The study was funded in part by the National Institute for Arthritis, Musculoskeletal, and Skin Diseases of the National Institutes of Health. Dr. Katz 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 – 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.