FDA Warns of Possible Liver Injury With Dronedarone

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FDA Warns of Possible Liver Injury With Dronedarone

The Food and Drug Administration on Jan. 14 issued a safety announcement about reports of rare but severe liver injury in patients taking dronedarone, including two patients who had acute liver failure that required transplantation.

Dronedarone (Multaq) is used to treat abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to the FDA.

The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with dronedarone.

The label’s adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.

Adverse events should be reported to MedWatch online or by calling (800) 332-1088.

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The Food and Drug Administration on Jan. 14 issued a safety announcement about reports of rare but severe liver injury in patients taking dronedarone, including two patients who had acute liver failure that required transplantation.

Dronedarone (Multaq) is used to treat abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to the FDA.

The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with dronedarone.

The label’s adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.

Adverse events should be reported to MedWatch online or by calling (800) 332-1088.

The Food and Drug Administration on Jan. 14 issued a safety announcement about reports of rare but severe liver injury in patients taking dronedarone, including two patients who had acute liver failure that required transplantation.

Dronedarone (Multaq) is used to treat abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to the FDA.

The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with dronedarone.

The label’s adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.

Adverse events should be reported to MedWatch online or by calling (800) 332-1088.

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European Study Estimates H1N1 Vaccine Effectiveness at 72%

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European Study Estimates H1N1 Vaccine Effectiveness at 72%

The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study published Jan. 11 in PLoS Medicine.

© CDC
    The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study. 

"The results of this study provide early estimates of the pandemic influenza vaccine effectiveness suggesting that the monovalent pandemic vaccines have been effective. The findings also give an indication of the vaccine effectiveness" for the influenza A (H1N1) 2009 strain included in the 2010-2011 seasonal vaccines, although specific vaccine effectiveness studies will have to be conducted to verify if similar rates of effectiveness are observed with 2010-2011 trivalent vaccines, Marta Valenciano, a veterinarian and epidemiologist at EpiConcept, Paris, and colleagues wrote in an accompanying summary of the study.

The study involved 2,902 patients with influenzalike illnesses (ILI) from France, Hungary, Ireland, Italy, Portugal, Romania, and Spain during the 2009-2010 season. All had throat swabs fewer than 8 days after the onset of symptoms. Among those patients, roughly 32% tested positive for pandemic H1N1. Investigators compared these confirmed H1N1 cases to patients with ILI who tested negative for any influenza virus.

[Perspective: Continue to Speak Up for Influenza Vaccination]

 Overall, 7% of all the patients – ranging from 0% in Italy to 29% in Hungary – had received at least one dose of the H1N1 vaccine more than 14 days before symptom onset.

The investigators adjusted their effectiveness results for confounding factors, including age; sex; presence and severity of chronic conditions; pregnancy; obesity; smoking history; number of practitioner visits in the preceding 12 months; use of influenza antivirals; and seasonal influenza vaccination during the previous two seasons.

As expected, vaccines that were delivered fewer than 8 days before the onset of ILI symptoms showed a relatively low adjusted effectiveness rate (19%), compared with 67% among those who were vaccinated more than 14 days before symptom onset.

[Comparable Cost-Effectiveness for Live Attenuated vs. Inactivated Influenza Vaccine]

The investigators also found that the 2009-2010 seasonal influenza vaccine was only 9.9% effective against H1N1 (PLoS Med. 2011 Jan. 11 [doi:10.1371/journal.pmed.1000388]).

The results of this study should be interpreted with caution because of limitations in the pandemic context (such as late timing of the studies, low incidence, and low vaccine coverage leading to imprecise estimates) and potential biases because of the study design, confounding factors, and missing values. The researchers recommended that, in the future, the sample size per country be enlarged in order to allow for precise pooled and stratified analyses.

Among the 19 authors of the study, several disclosed relationships with various pharmaceutical companies and European government agencies. The European Centre for Disease Prevention and Control funded the study.

Other influenza-related reports included the following:

• The U.K. Department of Health has warned physicians to watch for bacterial coinfections in patients with influenza. According to a Jan. 13 report in Pulse, an online newsletter for general practitioners, a "number of data sources suggest recent increases in some bacterial infections, particularly invasive Group A streptococcal infection and meningococcal disease." The report urged physicians to start antiviral and antibiotic treatment as soon as possible, when appropriate.

• According to a U.S. Centers for Disease Control and Prevention report, as of Jan. 1, ILI activity was high in Alabama, Georgia, Illinois, Louisiana, Mississippi, Oklahoma, and New York City; moderate in Nevada and New Jersey; and minimal to low in the rest of the country.

• Of 4,911 specimens from people with ILI, 20.3% tested positive for influenza, according to a CDC weekly report. Among those, 34.1% proved to be influenza B, and 65.9% were influenza A. No subtyping was performed in 52.3% of the influenza A samples, 41% were subtype A(H3), and 6.7% were A(2009 H1N1).

[SHEA Calls for Mandatory Influenza Vaccination for Health Care Workers]

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The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study published Jan. 11 in PLoS Medicine.

© CDC
    The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study. 

"The results of this study provide early estimates of the pandemic influenza vaccine effectiveness suggesting that the monovalent pandemic vaccines have been effective. The findings also give an indication of the vaccine effectiveness" for the influenza A (H1N1) 2009 strain included in the 2010-2011 seasonal vaccines, although specific vaccine effectiveness studies will have to be conducted to verify if similar rates of effectiveness are observed with 2010-2011 trivalent vaccines, Marta Valenciano, a veterinarian and epidemiologist at EpiConcept, Paris, and colleagues wrote in an accompanying summary of the study.

The study involved 2,902 patients with influenzalike illnesses (ILI) from France, Hungary, Ireland, Italy, Portugal, Romania, and Spain during the 2009-2010 season. All had throat swabs fewer than 8 days after the onset of symptoms. Among those patients, roughly 32% tested positive for pandemic H1N1. Investigators compared these confirmed H1N1 cases to patients with ILI who tested negative for any influenza virus.

[Perspective: Continue to Speak Up for Influenza Vaccination]

 Overall, 7% of all the patients – ranging from 0% in Italy to 29% in Hungary – had received at least one dose of the H1N1 vaccine more than 14 days before symptom onset.

The investigators adjusted their effectiveness results for confounding factors, including age; sex; presence and severity of chronic conditions; pregnancy; obesity; smoking history; number of practitioner visits in the preceding 12 months; use of influenza antivirals; and seasonal influenza vaccination during the previous two seasons.

As expected, vaccines that were delivered fewer than 8 days before the onset of ILI symptoms showed a relatively low adjusted effectiveness rate (19%), compared with 67% among those who were vaccinated more than 14 days before symptom onset.

[Comparable Cost-Effectiveness for Live Attenuated vs. Inactivated Influenza Vaccine]

The investigators also found that the 2009-2010 seasonal influenza vaccine was only 9.9% effective against H1N1 (PLoS Med. 2011 Jan. 11 [doi:10.1371/journal.pmed.1000388]).

The results of this study should be interpreted with caution because of limitations in the pandemic context (such as late timing of the studies, low incidence, and low vaccine coverage leading to imprecise estimates) and potential biases because of the study design, confounding factors, and missing values. The researchers recommended that, in the future, the sample size per country be enlarged in order to allow for precise pooled and stratified analyses.

Among the 19 authors of the study, several disclosed relationships with various pharmaceutical companies and European government agencies. The European Centre for Disease Prevention and Control funded the study.

Other influenza-related reports included the following:

• The U.K. Department of Health has warned physicians to watch for bacterial coinfections in patients with influenza. According to a Jan. 13 report in Pulse, an online newsletter for general practitioners, a "number of data sources suggest recent increases in some bacterial infections, particularly invasive Group A streptococcal infection and meningococcal disease." The report urged physicians to start antiviral and antibiotic treatment as soon as possible, when appropriate.

• According to a U.S. Centers for Disease Control and Prevention report, as of Jan. 1, ILI activity was high in Alabama, Georgia, Illinois, Louisiana, Mississippi, Oklahoma, and New York City; moderate in Nevada and New Jersey; and minimal to low in the rest of the country.

• Of 4,911 specimens from people with ILI, 20.3% tested positive for influenza, according to a CDC weekly report. Among those, 34.1% proved to be influenza B, and 65.9% were influenza A. No subtyping was performed in 52.3% of the influenza A samples, 41% were subtype A(H3), and 6.7% were A(2009 H1N1).

[SHEA Calls for Mandatory Influenza Vaccination for Health Care Workers]

The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study published Jan. 11 in PLoS Medicine.

© CDC
    The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study. 

"The results of this study provide early estimates of the pandemic influenza vaccine effectiveness suggesting that the monovalent pandemic vaccines have been effective. The findings also give an indication of the vaccine effectiveness" for the influenza A (H1N1) 2009 strain included in the 2010-2011 seasonal vaccines, although specific vaccine effectiveness studies will have to be conducted to verify if similar rates of effectiveness are observed with 2010-2011 trivalent vaccines, Marta Valenciano, a veterinarian and epidemiologist at EpiConcept, Paris, and colleagues wrote in an accompanying summary of the study.

The study involved 2,902 patients with influenzalike illnesses (ILI) from France, Hungary, Ireland, Italy, Portugal, Romania, and Spain during the 2009-2010 season. All had throat swabs fewer than 8 days after the onset of symptoms. Among those patients, roughly 32% tested positive for pandemic H1N1. Investigators compared these confirmed H1N1 cases to patients with ILI who tested negative for any influenza virus.

[Perspective: Continue to Speak Up for Influenza Vaccination]

 Overall, 7% of all the patients – ranging from 0% in Italy to 29% in Hungary – had received at least one dose of the H1N1 vaccine more than 14 days before symptom onset.

The investigators adjusted their effectiveness results for confounding factors, including age; sex; presence and severity of chronic conditions; pregnancy; obesity; smoking history; number of practitioner visits in the preceding 12 months; use of influenza antivirals; and seasonal influenza vaccination during the previous two seasons.

As expected, vaccines that were delivered fewer than 8 days before the onset of ILI symptoms showed a relatively low adjusted effectiveness rate (19%), compared with 67% among those who were vaccinated more than 14 days before symptom onset.

[Comparable Cost-Effectiveness for Live Attenuated vs. Inactivated Influenza Vaccine]

The investigators also found that the 2009-2010 seasonal influenza vaccine was only 9.9% effective against H1N1 (PLoS Med. 2011 Jan. 11 [doi:10.1371/journal.pmed.1000388]).

The results of this study should be interpreted with caution because of limitations in the pandemic context (such as late timing of the studies, low incidence, and low vaccine coverage leading to imprecise estimates) and potential biases because of the study design, confounding factors, and missing values. The researchers recommended that, in the future, the sample size per country be enlarged in order to allow for precise pooled and stratified analyses.

Among the 19 authors of the study, several disclosed relationships with various pharmaceutical companies and European government agencies. The European Centre for Disease Prevention and Control funded the study.

Other influenza-related reports included the following:

• The U.K. Department of Health has warned physicians to watch for bacterial coinfections in patients with influenza. According to a Jan. 13 report in Pulse, an online newsletter for general practitioners, a "number of data sources suggest recent increases in some bacterial infections, particularly invasive Group A streptococcal infection and meningococcal disease." The report urged physicians to start antiviral and antibiotic treatment as soon as possible, when appropriate.

• According to a U.S. Centers for Disease Control and Prevention report, as of Jan. 1, ILI activity was high in Alabama, Georgia, Illinois, Louisiana, Mississippi, Oklahoma, and New York City; moderate in Nevada and New Jersey; and minimal to low in the rest of the country.

• Of 4,911 specimens from people with ILI, 20.3% tested positive for influenza, according to a CDC weekly report. Among those, 34.1% proved to be influenza B, and 65.9% were influenza A. No subtyping was performed in 52.3% of the influenza A samples, 41% were subtype A(H3), and 6.7% were A(2009 H1N1).

[SHEA Calls for Mandatory Influenza Vaccination for Health Care Workers]

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European Study Estimates H1N1 Vaccine Effectiveness at 72%

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European Study Estimates H1N1 Vaccine Effectiveness at 72%

The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study published Jan. 11 in PLoS Medicine.

© CDC
    The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study. 

"The results of this study provide early estimates of the pandemic influenza vaccine effectiveness suggesting that the monovalent pandemic vaccines have been effective. The findings also give an indication of the vaccine effectiveness" for the influenza A (H1N1) 2009 strain included in the 2010-2011 seasonal vaccines, although specific vaccine effectiveness studies will have to be conducted to verify if similar rates of effectiveness are observed with 2010-2011 trivalent vaccines, Marta Valenciano, a veterinarian and epidemiologist at EpiConcept, Paris, and colleagues wrote in an accompanying summary of the study.

The study involved 2,902 patients with influenzalike illnesses (ILI) from France, Hungary, Ireland, Italy, Portugal, Romania, and Spain during the 2009-2010 season. All had throat swabs fewer than 8 days after the onset of symptoms. Among those patients, roughly 32% tested positive for pandemic H1N1. Investigators compared these confirmed H1N1 cases to patients with ILI who tested negative for any influenza virus.

[Perspective: Continue to Speak Up for Influenza Vaccination]

 Overall, 7% of all the patients – ranging from 0% in Italy to 29% in Hungary – had received at least one dose of the H1N1 vaccine more than 14 days before symptom onset.

The investigators adjusted their effectiveness results for confounding factors, including age; sex; presence and severity of chronic conditions; pregnancy; obesity; smoking history; number of practitioner visits in the preceding 12 months; use of influenza antivirals; and seasonal influenza vaccination during the previous two seasons.

As expected, vaccines that were delivered fewer than 8 days before the onset of ILI symptoms showed a relatively low adjusted effectiveness rate (19%), compared with 67% among those who were vaccinated more than 14 days before symptom onset.

[Comparable Cost-Effectiveness for Live Attenuated vs. Inactivated Influenza Vaccine]

The investigators also found that the 2009-2010 seasonal influenza vaccine was only 9.9% effective against H1N1 (PLoS Med. 2011 Jan. 11 [doi:10.1371/journal.pmed.1000388]).

The results of this study should be interpreted with caution because of limitations in the pandemic context (such as late timing of the studies, low incidence, and low vaccine coverage leading to imprecise estimates) and potential biases because of the study design, confounding factors, and missing values. The researchers recommended that, in the future, the sample size per country be enlarged in order to allow for precise pooled and stratified analyses.

Among the 19 authors of the study, several disclosed relationships with various pharmaceutical companies and European government agencies. The European Centre for Disease Prevention and Control funded the study.

Other influenza-related reports included the following:

• The U.K. Department of Health has warned physicians to watch for bacterial coinfections in patients with influenza. According to a Jan. 13 report in Pulse, an online newsletter for general practitioners, a "number of data sources suggest recent increases in some bacterial infections, particularly invasive Group A streptococcal infection and meningococcal disease." The report urged physicians to start antiviral and antibiotic treatment as soon as possible, when appropriate.

• According to a U.S. Centers for Disease Control and Prevention report, as of Jan. 1, ILI activity was high in Alabama, Georgia, Illinois, Louisiana, Mississippi, Oklahoma, and New York City; moderate in Nevada and New Jersey; and minimal to low in the rest of the country.

• Of 4,911 specimens from people with ILI, 20.3% tested positive for influenza, according to a CDC weekly report. Among those, 34.1% proved to be influenza B, and 65.9% were influenza A. No subtyping was performed in 52.3% of the influenza A samples, 41% were subtype A(H3), and 6.7% were A(2009 H1N1).

[SHEA Calls for Mandatory Influenza Vaccination for Health Care Workers]

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The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study published Jan. 11 in PLoS Medicine.

© CDC
    The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study. 

"The results of this study provide early estimates of the pandemic influenza vaccine effectiveness suggesting that the monovalent pandemic vaccines have been effective. The findings also give an indication of the vaccine effectiveness" for the influenza A (H1N1) 2009 strain included in the 2010-2011 seasonal vaccines, although specific vaccine effectiveness studies will have to be conducted to verify if similar rates of effectiveness are observed with 2010-2011 trivalent vaccines, Marta Valenciano, a veterinarian and epidemiologist at EpiConcept, Paris, and colleagues wrote in an accompanying summary of the study.

The study involved 2,902 patients with influenzalike illnesses (ILI) from France, Hungary, Ireland, Italy, Portugal, Romania, and Spain during the 2009-2010 season. All had throat swabs fewer than 8 days after the onset of symptoms. Among those patients, roughly 32% tested positive for pandemic H1N1. Investigators compared these confirmed H1N1 cases to patients with ILI who tested negative for any influenza virus.

[Perspective: Continue to Speak Up for Influenza Vaccination]

 Overall, 7% of all the patients – ranging from 0% in Italy to 29% in Hungary – had received at least one dose of the H1N1 vaccine more than 14 days before symptom onset.

The investigators adjusted their effectiveness results for confounding factors, including age; sex; presence and severity of chronic conditions; pregnancy; obesity; smoking history; number of practitioner visits in the preceding 12 months; use of influenza antivirals; and seasonal influenza vaccination during the previous two seasons.

As expected, vaccines that were delivered fewer than 8 days before the onset of ILI symptoms showed a relatively low adjusted effectiveness rate (19%), compared with 67% among those who were vaccinated more than 14 days before symptom onset.

[Comparable Cost-Effectiveness for Live Attenuated vs. Inactivated Influenza Vaccine]

The investigators also found that the 2009-2010 seasonal influenza vaccine was only 9.9% effective against H1N1 (PLoS Med. 2011 Jan. 11 [doi:10.1371/journal.pmed.1000388]).

The results of this study should be interpreted with caution because of limitations in the pandemic context (such as late timing of the studies, low incidence, and low vaccine coverage leading to imprecise estimates) and potential biases because of the study design, confounding factors, and missing values. The researchers recommended that, in the future, the sample size per country be enlarged in order to allow for precise pooled and stratified analyses.

Among the 19 authors of the study, several disclosed relationships with various pharmaceutical companies and European government agencies. The European Centre for Disease Prevention and Control funded the study.

Other influenza-related reports included the following:

• The U.K. Department of Health has warned physicians to watch for bacterial coinfections in patients with influenza. According to a Jan. 13 report in Pulse, an online newsletter for general practitioners, a "number of data sources suggest recent increases in some bacterial infections, particularly invasive Group A streptococcal infection and meningococcal disease." The report urged physicians to start antiviral and antibiotic treatment as soon as possible, when appropriate.

• According to a U.S. Centers for Disease Control and Prevention report, as of Jan. 1, ILI activity was high in Alabama, Georgia, Illinois, Louisiana, Mississippi, Oklahoma, and New York City; moderate in Nevada and New Jersey; and minimal to low in the rest of the country.

• Of 4,911 specimens from people with ILI, 20.3% tested positive for influenza, according to a CDC weekly report. Among those, 34.1% proved to be influenza B, and 65.9% were influenza A. No subtyping was performed in 52.3% of the influenza A samples, 41% were subtype A(H3), and 6.7% were A(2009 H1N1).

[SHEA Calls for Mandatory Influenza Vaccination for Health Care Workers]

The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study published Jan. 11 in PLoS Medicine.

© CDC
    The vaccine for pandemic 2009 H1N1 influenza was about 72% effective across seven European countries, according to findings from a case-control study. 

"The results of this study provide early estimates of the pandemic influenza vaccine effectiveness suggesting that the monovalent pandemic vaccines have been effective. The findings also give an indication of the vaccine effectiveness" for the influenza A (H1N1) 2009 strain included in the 2010-2011 seasonal vaccines, although specific vaccine effectiveness studies will have to be conducted to verify if similar rates of effectiveness are observed with 2010-2011 trivalent vaccines, Marta Valenciano, a veterinarian and epidemiologist at EpiConcept, Paris, and colleagues wrote in an accompanying summary of the study.

The study involved 2,902 patients with influenzalike illnesses (ILI) from France, Hungary, Ireland, Italy, Portugal, Romania, and Spain during the 2009-2010 season. All had throat swabs fewer than 8 days after the onset of symptoms. Among those patients, roughly 32% tested positive for pandemic H1N1. Investigators compared these confirmed H1N1 cases to patients with ILI who tested negative for any influenza virus.

[Perspective: Continue to Speak Up for Influenza Vaccination]

 Overall, 7% of all the patients – ranging from 0% in Italy to 29% in Hungary – had received at least one dose of the H1N1 vaccine more than 14 days before symptom onset.

The investigators adjusted their effectiveness results for confounding factors, including age; sex; presence and severity of chronic conditions; pregnancy; obesity; smoking history; number of practitioner visits in the preceding 12 months; use of influenza antivirals; and seasonal influenza vaccination during the previous two seasons.

As expected, vaccines that were delivered fewer than 8 days before the onset of ILI symptoms showed a relatively low adjusted effectiveness rate (19%), compared with 67% among those who were vaccinated more than 14 days before symptom onset.

[Comparable Cost-Effectiveness for Live Attenuated vs. Inactivated Influenza Vaccine]

The investigators also found that the 2009-2010 seasonal influenza vaccine was only 9.9% effective against H1N1 (PLoS Med. 2011 Jan. 11 [doi:10.1371/journal.pmed.1000388]).

The results of this study should be interpreted with caution because of limitations in the pandemic context (such as late timing of the studies, low incidence, and low vaccine coverage leading to imprecise estimates) and potential biases because of the study design, confounding factors, and missing values. The researchers recommended that, in the future, the sample size per country be enlarged in order to allow for precise pooled and stratified analyses.

Among the 19 authors of the study, several disclosed relationships with various pharmaceutical companies and European government agencies. The European Centre for Disease Prevention and Control funded the study.

Other influenza-related reports included the following:

• The U.K. Department of Health has warned physicians to watch for bacterial coinfections in patients with influenza. According to a Jan. 13 report in Pulse, an online newsletter for general practitioners, a "number of data sources suggest recent increases in some bacterial infections, particularly invasive Group A streptococcal infection and meningococcal disease." The report urged physicians to start antiviral and antibiotic treatment as soon as possible, when appropriate.

• According to a U.S. Centers for Disease Control and Prevention report, as of Jan. 1, ILI activity was high in Alabama, Georgia, Illinois, Louisiana, Mississippi, Oklahoma, and New York City; moderate in Nevada and New Jersey; and minimal to low in the rest of the country.

• Of 4,911 specimens from people with ILI, 20.3% tested positive for influenza, according to a CDC weekly report. Among those, 34.1% proved to be influenza B, and 65.9% were influenza A. No subtyping was performed in 52.3% of the influenza A samples, 41% were subtype A(H3), and 6.7% were A(2009 H1N1).

[SHEA Calls for Mandatory Influenza Vaccination for Health Care Workers]

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Age Is Associated With Mortality Risk in ICU Patients With Pneumonia

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Age Is Associated With Mortality Risk in ICU Patients With Pneumonia

VANCOUVER, B.C. – Age was independently associated with mortality in patients admitted to the ICU with pneumonia.

Overall mortality was 17% at 30 days and 32% at 1 year in a prospective, population-based cohort study involving 351 ICU patients. After adjustment for pneumonia severity, comorbid disease, sex, smoking status, alcohol use, and other potential confounders, each 10-year increase in age was associated with a 24% increase in 30-day mortality and a 39% increase in 1-year mortality, Dr. Wendy I. Sligl said at the annual meeting of the Infectious Diseases Society of America.

"This is a very high mortality rate, with almost one-third of patients dead at 1 year," said Dr. Sligl of the University of Alberta, Edmonton. Long-term mortality in these patients may rival or exceed that seen in patients with heart failure or end-stage renal disease.

"We tend to think of community-acquired pneumonia as a reversible problem. Patients come in, they get treated for their pneumonia, they come off the ventilator, they go home, and they’re fixed. And that really is not what we’re seeing with this data," she said.

Dr. Sligl and her fellow researchers enrolled all adults aged 17 years and older who were hospitalized with pneumonia in one of the six hospitals and five ICUs in Edmonton. The study excluded patients who were pregnant or lactating, had been previously hospitalized within 30 days, or were immunosuppressed. Of 3,415 patients admitted with pneumonia between 2000 and 2002, 351 were admitted to the ICU within 24 hours of their presentation at the emergency department.

The mean age of the 351 ICU patients was 61 years, with 43% younger than 60, 18% between 60 and 69, 23% between 70 and 79, and 15% aged 80 years and older (percentages do not total to 100% due to rounding). Most (59%) were male.

After adjustment for functional impairment, number of comorbidities, and illness severity in their multivariate analysis, the researchers found several independent predictors of mortality besides age. Patients with a living will had a threefold increase in 30-day mortality and a twofold increase in 1-year mortality. Every 10 points on the modified Pneumonia Severity Index increased the risk of 30-day mortality by 11% and the risk of 1-year mortality by 12%.

Dr. Sligl advanced several possible explanations for the independent relationship between age and mortality. Elderly patients may be frailer or have decreased reserve, she said. "This is very difficult to measure objectively and to include in multivariable modeling. There are many physiologic changes associated with aging that can predispose [a person to] the development of pneumonia and the severity of disease including decreased lung compliance, decreased respiratory muscle strength, retained secretions, ... and dysfunctional and impaired immunity."

Dr. Sligl said that she and her colleagues had no relevant financial disclosures.

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VANCOUVER, B.C. – Age was independently associated with mortality in patients admitted to the ICU with pneumonia.

Overall mortality was 17% at 30 days and 32% at 1 year in a prospective, population-based cohort study involving 351 ICU patients. After adjustment for pneumonia severity, comorbid disease, sex, smoking status, alcohol use, and other potential confounders, each 10-year increase in age was associated with a 24% increase in 30-day mortality and a 39% increase in 1-year mortality, Dr. Wendy I. Sligl said at the annual meeting of the Infectious Diseases Society of America.

"This is a very high mortality rate, with almost one-third of patients dead at 1 year," said Dr. Sligl of the University of Alberta, Edmonton. Long-term mortality in these patients may rival or exceed that seen in patients with heart failure or end-stage renal disease.

"We tend to think of community-acquired pneumonia as a reversible problem. Patients come in, they get treated for their pneumonia, they come off the ventilator, they go home, and they’re fixed. And that really is not what we’re seeing with this data," she said.

Dr. Sligl and her fellow researchers enrolled all adults aged 17 years and older who were hospitalized with pneumonia in one of the six hospitals and five ICUs in Edmonton. The study excluded patients who were pregnant or lactating, had been previously hospitalized within 30 days, or were immunosuppressed. Of 3,415 patients admitted with pneumonia between 2000 and 2002, 351 were admitted to the ICU within 24 hours of their presentation at the emergency department.

The mean age of the 351 ICU patients was 61 years, with 43% younger than 60, 18% between 60 and 69, 23% between 70 and 79, and 15% aged 80 years and older (percentages do not total to 100% due to rounding). Most (59%) were male.

After adjustment for functional impairment, number of comorbidities, and illness severity in their multivariate analysis, the researchers found several independent predictors of mortality besides age. Patients with a living will had a threefold increase in 30-day mortality and a twofold increase in 1-year mortality. Every 10 points on the modified Pneumonia Severity Index increased the risk of 30-day mortality by 11% and the risk of 1-year mortality by 12%.

Dr. Sligl advanced several possible explanations for the independent relationship between age and mortality. Elderly patients may be frailer or have decreased reserve, she said. "This is very difficult to measure objectively and to include in multivariable modeling. There are many physiologic changes associated with aging that can predispose [a person to] the development of pneumonia and the severity of disease including decreased lung compliance, decreased respiratory muscle strength, retained secretions, ... and dysfunctional and impaired immunity."

Dr. Sligl said that she and her colleagues had no relevant financial disclosures.

VANCOUVER, B.C. – Age was independently associated with mortality in patients admitted to the ICU with pneumonia.

Overall mortality was 17% at 30 days and 32% at 1 year in a prospective, population-based cohort study involving 351 ICU patients. After adjustment for pneumonia severity, comorbid disease, sex, smoking status, alcohol use, and other potential confounders, each 10-year increase in age was associated with a 24% increase in 30-day mortality and a 39% increase in 1-year mortality, Dr. Wendy I. Sligl said at the annual meeting of the Infectious Diseases Society of America.

"This is a very high mortality rate, with almost one-third of patients dead at 1 year," said Dr. Sligl of the University of Alberta, Edmonton. Long-term mortality in these patients may rival or exceed that seen in patients with heart failure or end-stage renal disease.

"We tend to think of community-acquired pneumonia as a reversible problem. Patients come in, they get treated for their pneumonia, they come off the ventilator, they go home, and they’re fixed. And that really is not what we’re seeing with this data," she said.

Dr. Sligl and her fellow researchers enrolled all adults aged 17 years and older who were hospitalized with pneumonia in one of the six hospitals and five ICUs in Edmonton. The study excluded patients who were pregnant or lactating, had been previously hospitalized within 30 days, or were immunosuppressed. Of 3,415 patients admitted with pneumonia between 2000 and 2002, 351 were admitted to the ICU within 24 hours of their presentation at the emergency department.

The mean age of the 351 ICU patients was 61 years, with 43% younger than 60, 18% between 60 and 69, 23% between 70 and 79, and 15% aged 80 years and older (percentages do not total to 100% due to rounding). Most (59%) were male.

After adjustment for functional impairment, number of comorbidities, and illness severity in their multivariate analysis, the researchers found several independent predictors of mortality besides age. Patients with a living will had a threefold increase in 30-day mortality and a twofold increase in 1-year mortality. Every 10 points on the modified Pneumonia Severity Index increased the risk of 30-day mortality by 11% and the risk of 1-year mortality by 12%.

Dr. Sligl advanced several possible explanations for the independent relationship between age and mortality. Elderly patients may be frailer or have decreased reserve, she said. "This is very difficult to measure objectively and to include in multivariable modeling. There are many physiologic changes associated with aging that can predispose [a person to] the development of pneumonia and the severity of disease including decreased lung compliance, decreased respiratory muscle strength, retained secretions, ... and dysfunctional and impaired immunity."

Dr. Sligl said that she and her colleagues had no relevant financial disclosures.

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Age Is Associated With Mortality Risk in ICU Patients With Pneumonia

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VANCOUVER, B.C. – Age was independently associated with mortality in patients admitted to the ICU with pneumonia.

Overall mortality was 17% at 30 days and 32% at 1 year in a prospective, population-based cohort study involving 351 ICU patients. After adjustment for pneumonia severity, comorbid disease, sex, smoking status, alcohol use, and other potential confounders, each 10-year increase in age was associated with a 24% increase in 30-day mortality and a 39% increase in 1-year mortality, Dr. Wendy I. Sligl said at the annual meeting of the Infectious Diseases Society of America.

"This is a very high mortality rate, with almost one-third of patients dead at 1 year," said Dr. Sligl of the University of Alberta, Edmonton. Long-term mortality in these patients may rival or exceed that seen in patients with heart failure or end-stage renal disease.

"We tend to think of community-acquired pneumonia as a reversible problem. Patients come in, they get treated for their pneumonia, they come off the ventilator, they go home, and they’re fixed. And that really is not what we’re seeing with this data," she said.

Dr. Sligl and her fellow researchers enrolled all adults aged 17 years and older who were hospitalized with pneumonia in one of the six hospitals and five ICUs in Edmonton. The study excluded patients who were pregnant or lactating, had been previously hospitalized within 30 days, or were immunosuppressed. Of 3,415 patients admitted with pneumonia between 2000 and 2002, 351 were admitted to the ICU within 24 hours of their presentation at the emergency department.

The mean age of the 351 ICU patients was 61 years, with 43% younger than 60, 18% between 60 and 69, 23% between 70 and 79, and 15% aged 80 years and older (percentages do not total to 100% due to rounding). Most (59%) were male.

After adjustment for functional impairment, number of comorbidities, and illness severity in their multivariate analysis, the researchers found several independent predictors of mortality besides age. Patients with a living will had a threefold increase in 30-day mortality and a twofold increase in 1-year mortality. Every 10 points on the modified Pneumonia Severity Index increased the risk of 30-day mortality by 11% and the risk of 1-year mortality by 12%.

Dr. Sligl advanced several possible explanations for the independent relationship between age and mortality. Elderly patients may be frailer or have decreased reserve, she said. "This is very difficult to measure objectively and to include in multivariable modeling. There are many physiologic changes associated with aging that can predispose [a person to] the development of pneumonia and the severity of disease including decreased lung compliance, decreased respiratory muscle strength, retained secretions, ... and dysfunctional and impaired immunity."

Dr. Sligl said that she and her colleagues had no relevant financial disclosures.

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VANCOUVER, B.C. – Age was independently associated with mortality in patients admitted to the ICU with pneumonia.

Overall mortality was 17% at 30 days and 32% at 1 year in a prospective, population-based cohort study involving 351 ICU patients. After adjustment for pneumonia severity, comorbid disease, sex, smoking status, alcohol use, and other potential confounders, each 10-year increase in age was associated with a 24% increase in 30-day mortality and a 39% increase in 1-year mortality, Dr. Wendy I. Sligl said at the annual meeting of the Infectious Diseases Society of America.

"This is a very high mortality rate, with almost one-third of patients dead at 1 year," said Dr. Sligl of the University of Alberta, Edmonton. Long-term mortality in these patients may rival or exceed that seen in patients with heart failure or end-stage renal disease.

"We tend to think of community-acquired pneumonia as a reversible problem. Patients come in, they get treated for their pneumonia, they come off the ventilator, they go home, and they’re fixed. And that really is not what we’re seeing with this data," she said.

Dr. Sligl and her fellow researchers enrolled all adults aged 17 years and older who were hospitalized with pneumonia in one of the six hospitals and five ICUs in Edmonton. The study excluded patients who were pregnant or lactating, had been previously hospitalized within 30 days, or were immunosuppressed. Of 3,415 patients admitted with pneumonia between 2000 and 2002, 351 were admitted to the ICU within 24 hours of their presentation at the emergency department.

The mean age of the 351 ICU patients was 61 years, with 43% younger than 60, 18% between 60 and 69, 23% between 70 and 79, and 15% aged 80 years and older (percentages do not total to 100% due to rounding). Most (59%) were male.

After adjustment for functional impairment, number of comorbidities, and illness severity in their multivariate analysis, the researchers found several independent predictors of mortality besides age. Patients with a living will had a threefold increase in 30-day mortality and a twofold increase in 1-year mortality. Every 10 points on the modified Pneumonia Severity Index increased the risk of 30-day mortality by 11% and the risk of 1-year mortality by 12%.

Dr. Sligl advanced several possible explanations for the independent relationship between age and mortality. Elderly patients may be frailer or have decreased reserve, she said. "This is very difficult to measure objectively and to include in multivariable modeling. There are many physiologic changes associated with aging that can predispose [a person to] the development of pneumonia and the severity of disease including decreased lung compliance, decreased respiratory muscle strength, retained secretions, ... and dysfunctional and impaired immunity."

Dr. Sligl said that she and her colleagues had no relevant financial disclosures.

VANCOUVER, B.C. – Age was independently associated with mortality in patients admitted to the ICU with pneumonia.

Overall mortality was 17% at 30 days and 32% at 1 year in a prospective, population-based cohort study involving 351 ICU patients. After adjustment for pneumonia severity, comorbid disease, sex, smoking status, alcohol use, and other potential confounders, each 10-year increase in age was associated with a 24% increase in 30-day mortality and a 39% increase in 1-year mortality, Dr. Wendy I. Sligl said at the annual meeting of the Infectious Diseases Society of America.

"This is a very high mortality rate, with almost one-third of patients dead at 1 year," said Dr. Sligl of the University of Alberta, Edmonton. Long-term mortality in these patients may rival or exceed that seen in patients with heart failure or end-stage renal disease.

"We tend to think of community-acquired pneumonia as a reversible problem. Patients come in, they get treated for their pneumonia, they come off the ventilator, they go home, and they’re fixed. And that really is not what we’re seeing with this data," she said.

Dr. Sligl and her fellow researchers enrolled all adults aged 17 years and older who were hospitalized with pneumonia in one of the six hospitals and five ICUs in Edmonton. The study excluded patients who were pregnant or lactating, had been previously hospitalized within 30 days, or were immunosuppressed. Of 3,415 patients admitted with pneumonia between 2000 and 2002, 351 were admitted to the ICU within 24 hours of their presentation at the emergency department.

The mean age of the 351 ICU patients was 61 years, with 43% younger than 60, 18% between 60 and 69, 23% between 70 and 79, and 15% aged 80 years and older (percentages do not total to 100% due to rounding). Most (59%) were male.

After adjustment for functional impairment, number of comorbidities, and illness severity in their multivariate analysis, the researchers found several independent predictors of mortality besides age. Patients with a living will had a threefold increase in 30-day mortality and a twofold increase in 1-year mortality. Every 10 points on the modified Pneumonia Severity Index increased the risk of 30-day mortality by 11% and the risk of 1-year mortality by 12%.

Dr. Sligl advanced several possible explanations for the independent relationship between age and mortality. Elderly patients may be frailer or have decreased reserve, she said. "This is very difficult to measure objectively and to include in multivariable modeling. There are many physiologic changes associated with aging that can predispose [a person to] the development of pneumonia and the severity of disease including decreased lung compliance, decreased respiratory muscle strength, retained secretions, ... and dysfunctional and impaired immunity."

Dr. Sligl said that she and her colleagues had no relevant financial disclosures.

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Major Finding: For every 10-year increase in age in ICU patients with pneumonia, the risk of 30-day mortality increased by 24% and the risk of 1-year mortality increased by 39%.

Data Source: Prospective, population-based cohort study involving 351 patients admitted to ICUs in Edmonton, Alberta, Canada between 2000 and 2002.

Disclosures: Dr. Sligl said that she had no relevant financial disclosures.

Omega-3 Fatty Acid Supplements May Ease Heart Failure Symptoms

Results Suggest Introducing Omega-3 Fatty Acids Early in Heart Failure
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Omega-3 Fatty Acid Supplements May Ease Heart Failure Symptoms

Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.

Photo credit: Wikimedia Commons image by Thevisualmd.com.
Investigators gave patients with chronic heart failure a combination of docosahexaneoic acid (DHA) and eicosapentaenoic acid (EPA), the two main omega-3 polyunsaturated fatty acids.    

The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).

"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."

At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.

The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).

The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.

The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.

Body

In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.

"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.

"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."

Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.

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Body

In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.

"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.

"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."

Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.

Body

In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.

"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.

"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."

Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.

Title
Results Suggest Introducing Omega-3 Fatty Acids Early in Heart Failure
Results Suggest Introducing Omega-3 Fatty Acids Early in Heart Failure

Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.

Photo credit: Wikimedia Commons image by Thevisualmd.com.
Investigators gave patients with chronic heart failure a combination of docosahexaneoic acid (DHA) and eicosapentaenoic acid (EPA), the two main omega-3 polyunsaturated fatty acids.    

The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).

"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."

At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.

The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).

The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.

The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.

Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.

Photo credit: Wikimedia Commons image by Thevisualmd.com.
Investigators gave patients with chronic heart failure a combination of docosahexaneoic acid (DHA) and eicosapentaenoic acid (EPA), the two main omega-3 polyunsaturated fatty acids.    

The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).

"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."

At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.

The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).

The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.

The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.

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Omega-3 Fatty Acid Supplements May Ease Heart Failure Symptoms

Results Suggest Introducing Omega-3 Fatty Acids Early in Heart Failure
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Omega-3 Fatty Acid Supplements May Ease Heart Failure Symptoms

Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.

Photo credit: Wikimedia Commons image by Thevisualmd.com
Investigators gave patients with chronic heart failure a combination of docosahexaneoic acid (DHA) and eicosapentaenoic acid (EPA), the two main omega-3 polyunsaturated fatty acids.    

The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).

"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."

At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.

The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).

The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.

The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.

Body

In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.

"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.

"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."

Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.

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In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.

"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.

"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."

Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.

Body

In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.

"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.

"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."

Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.

Title
Results Suggest Introducing Omega-3 Fatty Acids Early in Heart Failure
Results Suggest Introducing Omega-3 Fatty Acids Early in Heart Failure

Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.

Photo credit: Wikimedia Commons image by Thevisualmd.com
Investigators gave patients with chronic heart failure a combination of docosahexaneoic acid (DHA) and eicosapentaenoic acid (EPA), the two main omega-3 polyunsaturated fatty acids.    

The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).

"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."

At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.

The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).

The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.

The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.

Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.

Photo credit: Wikimedia Commons image by Thevisualmd.com
Investigators gave patients with chronic heart failure a combination of docosahexaneoic acid (DHA) and eicosapentaenoic acid (EPA), the two main omega-3 polyunsaturated fatty acids.    

The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).

"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."

At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.

The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).

The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.

The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.

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Omega-3 Fatty Acid Supplements May Ease Heart Failure Symptoms
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Omega-3 Fatty Acid Supplements May Ease Heart Failure Symptoms
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Major Finding: Twelve months of daily omega-3 fatty acid supplementation resulted in a 10% improvement in left ventricle ejection fraction, a 6% increase in peak VO2, a 7.5% increase in exercise duration, and significant improvements in New York Heart Association functional class.

Data Source: Randomized, double-blind, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.

Disclosures: The study was funded by the University of Brescia. One study coauthors acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.

Mesh/No Mesh Prolapse Repair: Cure Rates Similar

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Major Finding: After an average 14.7 months of follow-up in a study of 65 women, 96% of women undergoing mesh colpopexy and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms, a difference that was not significant. The vaginal mesh erosion rate was relatively high at 15.6%.

Data Source: Randomized, double-blind, controlled trial of 65 women with pelvic organ prolapse stages 2–4.

Disclosures: The study was supported by research grants from the AUGS Foundation and the MedStar Health Research Institute. Ethicon Women's Health and Urology donated the Prolift mesh kits for this study. Dr. Sokol said he had no conflicts of interest.

LONG BEACH, CALIF. – A randomized controlled trial found no advantage for vaginal prolapse repair using mesh colpopexy compared with no-mesh repair, said Dr. Andrew I. Sokol of Washington (D.C.) Hospital Center.

After an average follow-up of 14.7 months in this study of 65 women, 96% of women undergoing mesh colpopexy with Prolift (Ethicon Women's Health and Urology) and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms; 25% of the mesh group and 22% of the no-mesh group experienced recurrent prolapse beyond the hymen. Neither of these differences was significant.

A total of 38% of women in the mesh group, compared with 30% of women in the no-mesh group, achieved optimal scores (stage 1 or below) on the pelvic organ prolapse quantification (POP-Q) scale, a difference that was not significant. On the other hand, the vaginal mesh erosion rate was relatively high at 15.6%, and the data safety monitoring board (DSMB) terminated the study early because of this, Dr. Sokol said.

In addition, there were three reoperations for erosion and three reoperations for prolapse among patients in the mesh group, compared with no reoperations in the no-mesh group, a significant difference.

In October 2008 the Food and Drug Administration issued a formal notification on reported complications from mesh use. Recognizing the high complication rate, mesh manufacturers have developed lighter-weight and mixed composite meshes. They have also developed trocarless mesh kits to minimize risks of visceral injury and groin pain, Dr. Sokol said. But long-term data are not yet available on these products.

The study included 65 women who were at POP-Q stages 2–4 uterovaginal or vaginal prolapse and who desired vaginal reconstructive surgery; the mean age in both groups was 64 years. The patients were randomized in the operating room after they had received anesthesia, and the research staff and the patient were blinded to the treatment assignment.

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Major Finding: After an average 14.7 months of follow-up in a study of 65 women, 96% of women undergoing mesh colpopexy and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms, a difference that was not significant. The vaginal mesh erosion rate was relatively high at 15.6%.

Data Source: Randomized, double-blind, controlled trial of 65 women with pelvic organ prolapse stages 2–4.

Disclosures: The study was supported by research grants from the AUGS Foundation and the MedStar Health Research Institute. Ethicon Women's Health and Urology donated the Prolift mesh kits for this study. Dr. Sokol said he had no conflicts of interest.

LONG BEACH, CALIF. – A randomized controlled trial found no advantage for vaginal prolapse repair using mesh colpopexy compared with no-mesh repair, said Dr. Andrew I. Sokol of Washington (D.C.) Hospital Center.

After an average follow-up of 14.7 months in this study of 65 women, 96% of women undergoing mesh colpopexy with Prolift (Ethicon Women's Health and Urology) and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms; 25% of the mesh group and 22% of the no-mesh group experienced recurrent prolapse beyond the hymen. Neither of these differences was significant.

A total of 38% of women in the mesh group, compared with 30% of women in the no-mesh group, achieved optimal scores (stage 1 or below) on the pelvic organ prolapse quantification (POP-Q) scale, a difference that was not significant. On the other hand, the vaginal mesh erosion rate was relatively high at 15.6%, and the data safety monitoring board (DSMB) terminated the study early because of this, Dr. Sokol said.

In addition, there were three reoperations for erosion and three reoperations for prolapse among patients in the mesh group, compared with no reoperations in the no-mesh group, a significant difference.

In October 2008 the Food and Drug Administration issued a formal notification on reported complications from mesh use. Recognizing the high complication rate, mesh manufacturers have developed lighter-weight and mixed composite meshes. They have also developed trocarless mesh kits to minimize risks of visceral injury and groin pain, Dr. Sokol said. But long-term data are not yet available on these products.

The study included 65 women who were at POP-Q stages 2–4 uterovaginal or vaginal prolapse and who desired vaginal reconstructive surgery; the mean age in both groups was 64 years. The patients were randomized in the operating room after they had received anesthesia, and the research staff and the patient were blinded to the treatment assignment.

Major Finding: After an average 14.7 months of follow-up in a study of 65 women, 96% of women undergoing mesh colpopexy and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms, a difference that was not significant. The vaginal mesh erosion rate was relatively high at 15.6%.

Data Source: Randomized, double-blind, controlled trial of 65 women with pelvic organ prolapse stages 2–4.

Disclosures: The study was supported by research grants from the AUGS Foundation and the MedStar Health Research Institute. Ethicon Women's Health and Urology donated the Prolift mesh kits for this study. Dr. Sokol said he had no conflicts of interest.

LONG BEACH, CALIF. – A randomized controlled trial found no advantage for vaginal prolapse repair using mesh colpopexy compared with no-mesh repair, said Dr. Andrew I. Sokol of Washington (D.C.) Hospital Center.

After an average follow-up of 14.7 months in this study of 65 women, 96% of women undergoing mesh colpopexy with Prolift (Ethicon Women's Health and Urology) and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms; 25% of the mesh group and 22% of the no-mesh group experienced recurrent prolapse beyond the hymen. Neither of these differences was significant.

A total of 38% of women in the mesh group, compared with 30% of women in the no-mesh group, achieved optimal scores (stage 1 or below) on the pelvic organ prolapse quantification (POP-Q) scale, a difference that was not significant. On the other hand, the vaginal mesh erosion rate was relatively high at 15.6%, and the data safety monitoring board (DSMB) terminated the study early because of this, Dr. Sokol said.

In addition, there were three reoperations for erosion and three reoperations for prolapse among patients in the mesh group, compared with no reoperations in the no-mesh group, a significant difference.

In October 2008 the Food and Drug Administration issued a formal notification on reported complications from mesh use. Recognizing the high complication rate, mesh manufacturers have developed lighter-weight and mixed composite meshes. They have also developed trocarless mesh kits to minimize risks of visceral injury and groin pain, Dr. Sokol said. But long-term data are not yet available on these products.

The study included 65 women who were at POP-Q stages 2–4 uterovaginal or vaginal prolapse and who desired vaginal reconstructive surgery; the mean age in both groups was 64 years. The patients were randomized in the operating room after they had received anesthesia, and the research staff and the patient were blinded to the treatment assignment.

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Sexual Function Improves With Successful SUI Tx

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Sexual Function Improves With Successful SUI Tx

Major Finding: Three months after successful nonsurgical treatment for stress incontinence, women had a 2.3-point mean improvement in scores on the PISQ-12, while women whose treatment was not successful had a 0.5-point improvement.

Data Source: Planned prospective supplementary study of 445 women with stress or mixed urinary incontinence participating in the ATLAS trial.

Disclosures: The National Institute of Child Health and Human Development sponsored the trial. Dr. Handa said she had no financial disclosures.

LONG BEACH, CALIF. – Women with urinary incontinence who were successfully treated nonsurgically showed significantly greater improvement in sexual function than women whose incontinence did not improve, a study has shown.

Three months after treatment with behavioral therapy, a continence pessary, or both, women whose treatment was successful had a 2.3-point mean improvement in their score on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Women whose incontinence treatment was not successful had a 0.5-point mean improvement on the PISQ-12. The difference was statistically significant, said Dr. Victoria L. Handa of Johns Hopkins University, Baltimore.

Dr. Handa's study was a planned, prospective secondary analysis of results from the Ambulatory Treatments for Leakage Associated With Stress (ATLAS) trial.

That trial involved 445 women with stress urinary incontinence (SUI) or mixed incontinence in which SUI predominated. The women were randomized to receive behavioral therapy, consisting mostly of pelvic muscle training, a continence pessary, or both.

The women were a mean of 50 years old, and about 46% had SUI only.

After 3 months of follow-up, there were no significant differences among the three treatment groups on any measure of sexual function.

“I think there is this perception that Kegel exercises are good for sexual function, but in a separate analysis, we didn't see any association between improvement in pelvic muscle function as measured by Brink score and any measure of sexual function,” Dr. Handa said.

In addition to showing significant improvements in total PISQ-12 scores, women who were successfully treated had significant improvements in two specific symptoms.

They were less likely to report urinary incontinence with sexual activity, and less likely to say that they restricted their sexual activity because of fears of incontinence.

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Major Finding: Three months after successful nonsurgical treatment for stress incontinence, women had a 2.3-point mean improvement in scores on the PISQ-12, while women whose treatment was not successful had a 0.5-point improvement.

Data Source: Planned prospective supplementary study of 445 women with stress or mixed urinary incontinence participating in the ATLAS trial.

Disclosures: The National Institute of Child Health and Human Development sponsored the trial. Dr. Handa said she had no financial disclosures.

LONG BEACH, CALIF. – Women with urinary incontinence who were successfully treated nonsurgically showed significantly greater improvement in sexual function than women whose incontinence did not improve, a study has shown.

Three months after treatment with behavioral therapy, a continence pessary, or both, women whose treatment was successful had a 2.3-point mean improvement in their score on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Women whose incontinence treatment was not successful had a 0.5-point mean improvement on the PISQ-12. The difference was statistically significant, said Dr. Victoria L. Handa of Johns Hopkins University, Baltimore.

Dr. Handa's study was a planned, prospective secondary analysis of results from the Ambulatory Treatments for Leakage Associated With Stress (ATLAS) trial.

That trial involved 445 women with stress urinary incontinence (SUI) or mixed incontinence in which SUI predominated. The women were randomized to receive behavioral therapy, consisting mostly of pelvic muscle training, a continence pessary, or both.

The women were a mean of 50 years old, and about 46% had SUI only.

After 3 months of follow-up, there were no significant differences among the three treatment groups on any measure of sexual function.

“I think there is this perception that Kegel exercises are good for sexual function, but in a separate analysis, we didn't see any association between improvement in pelvic muscle function as measured by Brink score and any measure of sexual function,” Dr. Handa said.

In addition to showing significant improvements in total PISQ-12 scores, women who were successfully treated had significant improvements in two specific symptoms.

They were less likely to report urinary incontinence with sexual activity, and less likely to say that they restricted their sexual activity because of fears of incontinence.

Major Finding: Three months after successful nonsurgical treatment for stress incontinence, women had a 2.3-point mean improvement in scores on the PISQ-12, while women whose treatment was not successful had a 0.5-point improvement.

Data Source: Planned prospective supplementary study of 445 women with stress or mixed urinary incontinence participating in the ATLAS trial.

Disclosures: The National Institute of Child Health and Human Development sponsored the trial. Dr. Handa said she had no financial disclosures.

LONG BEACH, CALIF. – Women with urinary incontinence who were successfully treated nonsurgically showed significantly greater improvement in sexual function than women whose incontinence did not improve, a study has shown.

Three months after treatment with behavioral therapy, a continence pessary, or both, women whose treatment was successful had a 2.3-point mean improvement in their score on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Women whose incontinence treatment was not successful had a 0.5-point mean improvement on the PISQ-12. The difference was statistically significant, said Dr. Victoria L. Handa of Johns Hopkins University, Baltimore.

Dr. Handa's study was a planned, prospective secondary analysis of results from the Ambulatory Treatments for Leakage Associated With Stress (ATLAS) trial.

That trial involved 445 women with stress urinary incontinence (SUI) or mixed incontinence in which SUI predominated. The women were randomized to receive behavioral therapy, consisting mostly of pelvic muscle training, a continence pessary, or both.

The women were a mean of 50 years old, and about 46% had SUI only.

After 3 months of follow-up, there were no significant differences among the three treatment groups on any measure of sexual function.

“I think there is this perception that Kegel exercises are good for sexual function, but in a separate analysis, we didn't see any association between improvement in pelvic muscle function as measured by Brink score and any measure of sexual function,” Dr. Handa said.

In addition to showing significant improvements in total PISQ-12 scores, women who were successfully treated had significant improvements in two specific symptoms.

They were less likely to report urinary incontinence with sexual activity, and less likely to say that they restricted their sexual activity because of fears of incontinence.

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Universal Combo Strategy Best Against MRSA's Spread in ICU

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VANCOUVER, B.C. — The most effective strategy for preventing colonizations and infections with methicillin-resistant Staphylococcus aureus in ICUs is a combination of universal contact precautions and universal decolonization, according to a computer simulation analysis.

Among a hypothetical cohort of 100,000 adult patients admitted to ICUs, such a combination strategy would prevent an estimated 54% of colonizations and 51% of MRSA infections compared with standard precautions, Dr. Courtney A. Gidengil said at the meeting.

Standard precautions include careful hand washing by health care workers and appropriate cleaning of the hospital environment. Universal contact precautions involve isolating affected patients in a private room or in a room with other MRSA patients. All health care workers must don gloves and gowns before seeing the patient. Universal decolonization involves daily chlorhexidine gluconate (CHG) baths along with twice-daily applications of mupirocin nasal ointment, both for 5 days.

The next most effective strategy, according to the analysis, would be a combination of universal contact precautions and universal CHG baths, which would prevent about 38% of colonizations and 40% of infections, said Dr. Gidengil of Children's Hospital Boston and the Rand Corp.

Universal decolonization alone would prevent 34% of colonizations and 40% of infections. Universal contact precautions alone would prevent 29% of colonizations and 26% of infections. And universal CHG baths alone would prevent 12% of colonizations and 23% of infections.

Dr Gidengil and her coinvestigators reported having no conflicts of interest. The Centers for Disease Control and Prevention and the National Institute of General Medical Sciences funded the study.

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VANCOUVER, B.C. — The most effective strategy for preventing colonizations and infections with methicillin-resistant Staphylococcus aureus in ICUs is a combination of universal contact precautions and universal decolonization, according to a computer simulation analysis.

Among a hypothetical cohort of 100,000 adult patients admitted to ICUs, such a combination strategy would prevent an estimated 54% of colonizations and 51% of MRSA infections compared with standard precautions, Dr. Courtney A. Gidengil said at the meeting.

Standard precautions include careful hand washing by health care workers and appropriate cleaning of the hospital environment. Universal contact precautions involve isolating affected patients in a private room or in a room with other MRSA patients. All health care workers must don gloves and gowns before seeing the patient. Universal decolonization involves daily chlorhexidine gluconate (CHG) baths along with twice-daily applications of mupirocin nasal ointment, both for 5 days.

The next most effective strategy, according to the analysis, would be a combination of universal contact precautions and universal CHG baths, which would prevent about 38% of colonizations and 40% of infections, said Dr. Gidengil of Children's Hospital Boston and the Rand Corp.

Universal decolonization alone would prevent 34% of colonizations and 40% of infections. Universal contact precautions alone would prevent 29% of colonizations and 26% of infections. And universal CHG baths alone would prevent 12% of colonizations and 23% of infections.

Dr Gidengil and her coinvestigators reported having no conflicts of interest. The Centers for Disease Control and Prevention and the National Institute of General Medical Sciences funded the study.

VANCOUVER, B.C. — The most effective strategy for preventing colonizations and infections with methicillin-resistant Staphylococcus aureus in ICUs is a combination of universal contact precautions and universal decolonization, according to a computer simulation analysis.

Among a hypothetical cohort of 100,000 adult patients admitted to ICUs, such a combination strategy would prevent an estimated 54% of colonizations and 51% of MRSA infections compared with standard precautions, Dr. Courtney A. Gidengil said at the meeting.

Standard precautions include careful hand washing by health care workers and appropriate cleaning of the hospital environment. Universal contact precautions involve isolating affected patients in a private room or in a room with other MRSA patients. All health care workers must don gloves and gowns before seeing the patient. Universal decolonization involves daily chlorhexidine gluconate (CHG) baths along with twice-daily applications of mupirocin nasal ointment, both for 5 days.

The next most effective strategy, according to the analysis, would be a combination of universal contact precautions and universal CHG baths, which would prevent about 38% of colonizations and 40% of infections, said Dr. Gidengil of Children's Hospital Boston and the Rand Corp.

Universal decolonization alone would prevent 34% of colonizations and 40% of infections. Universal contact precautions alone would prevent 29% of colonizations and 26% of infections. And universal CHG baths alone would prevent 12% of colonizations and 23% of infections.

Dr Gidengil and her coinvestigators reported having no conflicts of interest. The Centers for Disease Control and Prevention and the National Institute of General Medical Sciences funded the study.

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Universal Combo Strategy Best Against MRSA's Spread in ICU
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Universal Combo Strategy Best Against MRSA's Spread in ICU
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