Heidi Splete

Amoxicillin and Acute Otitis Media

A standard daily dose of 40–45 mg/kg per day amoxicillin is an appropriate first-line antibiotic for children with acute otitis media who have received at least three doses of the heptavalent pneumococcal conjugate vaccine, if treatment is needed, reported Dr. Jane Garbutt and her colleagues at Washington University, St. Louis.

If therapy is necessary, high-dose amoxicillin may be appropriate for unvaccinated children or for those who have received fewer than three doses of the vaccine (Pediatrics 2006;117:1087–94).

An increase in vaccination with at least three doses of heptavalent pneumococcal conjugate vaccine (PCV7) from 0% to 54% in a St. Louis community from 2001 to 2004 appeared to reduce the prevalence of Streptococcus pneumoniae isolates that were not susceptible to penicillin (NSSP), whereas the prevalence of S. pneumoniae not susceptible to amoxicillin (NSSP-A) remained low.

The investigators reviewed data from 327 children younger than 7 years old with new diagnoses of acute otitis media, otitis media with effusion, acute sinusitis, streptococcal pharyngitis, nonspecific upper respiratory tract infections, or a cough illness during the 4-year period.

The prevalence of NSSP was significantly reduced in children with any diagnosis who had received at least three doses of PCV7, compared with those who had fewer or no doses (8% vs. 20%), and no NSSP-A isolates were found among the study children who had received at least three doses of the PCV7 vaccine.

In addition, vaccination with at least three doses of PCV7 was protective for all child care attendees, but vaccination with at least one dose was not protective.

Antibiotics End K. kingae Outbreak

An outbreak of three Kingella kingae infections at a day care center was contained using prophylactic antibiotics, reported Dr. Pablo Yagupsky of Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his colleagues.

The findings confirm the susceptibility of day care populations to invasive disease. K. kingae has a particularly high carriage rate among very young children, who frequently put their hands or other objects into their mouths and spread the organisms through saliva, the investigators noted (Pediatr. Infect. Dis. J. 2006;25:526–32).

The outbreak occurred during a period of 15 days (starting on March 10, 2005), when three children aged 8–12 months who attended the same day care center showed signs of bone infection, and osteomyelitis was confirmed. All three children were hospitalized and treated, and all three recovered uneventfully. K. kingae was confirmed in one patient and suspected in the other two.

Surveillance cultures taken from several day care centers before the administration of prophylactic antibiotics yielded K. kingae isolates in 4 of 11 attendees at the index facility and 5 of 12 and 1 of 15 attendees at neighboring facilities. The confirmed K. kingae isolate was the same strain as other isolates from the same day care center, but different from strains found at neighboring facilities.

All children aged 6–30 months who lived in the community started an antibiotic regimen of 20 mg/kg oral rifampin twice daily for 2 days, followed by 80 mg/kg amoxicillin twice daily for 4 days. The carrier rate was significantly reduced from 11 children (28%) to 2 children (5%) among the 40 children who completed the course of antibiotic therapy.

Dexamethasone Eases Pharyngitis

Children with streptococcal pharyngitis who were treated with dexamethasone as an add-on therapy showed significant improvement in general condition and activity levels after about 1 day, compared with 2 days for those who were treated with a placebo in a pilot study.

In addition, children who received three daily doses of dexamethasone showed significant improvement in their sore throat symptoms, whereas those who received one daily dose did not show such improvement, reported Dr. Mary-Lynn Niland and her colleagues at Ohio State University, Columbus.

Steroids have been shown to mitigate throat pain in adults with pharyngitis, and the researchers sought to assess the effects of extended dosage on symptoms in children (Pediatr. Infect. Dis. J. 2006;25:477–81).

A total of 90 children aged 4–21 years with group A beta hemolytic streptococcal pharyngitis were randomized to receive one oral daily dose of 0.6 mg/kg dexamethasone (maximum dose 10 mg), three oral daily doses of 0.6 mg/kg dexamethasone (maximum dose 10 mg), or a placebo in addition to an oral or intramuscular antibiotic.

The children were assessed by a combination of telephone interviews and symptom diaries.

Amoxicillin and Acute Otitis Media

A standard daily dose of 40–45 mg/kg per day amoxicillin is an appropriate first-line antibiotic for children with acute otitis media who have received at least three doses of the heptavalent pneumococcal conjugate vaccine, if treatment is needed, reported Dr. Jane Garbutt and her colleagues at Washington University, St. Louis.

If therapy is necessary, high-dose amoxicillin may be appropriate for unvaccinated children or for those who have received fewer than three doses of the vaccine (Pediatrics 2006;117:1087–94).

An increase in vaccination with at least three doses of heptavalent pneumococcal conjugate vaccine (PCV7) from 0% to 54% in a St. Louis community from 2001 to 2004 appeared to reduce the prevalence of Streptococcus pneumoniae isolates that were not susceptible to penicillin (NSSP), whereas the prevalence of S. pneumoniae not susceptible to amoxicillin (NSSP-A) remained low.

The investigators reviewed data from 327 children younger than 7 years old with new diagnoses of acute otitis media, otitis media with effusion, acute sinusitis, streptococcal pharyngitis, nonspecific upper respiratory tract infections, or a cough illness during the 4-year period.

The prevalence of NSSP was significantly reduced in children with any diagnosis who had received at least three doses of PCV7, compared with those who had fewer or no doses (8% vs. 20%), and no NSSP-A isolates were found among the study children who had received at least three doses of the PCV7 vaccine.

In addition, vaccination with at least three doses of PCV7 was protective for all child care attendees, but vaccination with at least one dose was not protective.

Antibiotics End K. kingae Outbreak

An outbreak of three Kingella kingae infections at a day care center was contained using prophylactic antibiotics, reported Dr. Pablo Yagupsky of Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his colleagues.

The findings confirm the susceptibility of day care populations to invasive disease. K. kingae has a particularly high carriage rate among very young children, who frequently put their hands or other objects into their mouths and spread the organisms through saliva, the investigators noted (Pediatr. Infect. Dis. J. 2006;25:526–32).

The outbreak occurred during a period of 15 days (starting on March 10, 2005), when three children aged 8–12 months who attended the same day care center showed signs of bone infection, and osteomyelitis was confirmed. All three children were hospitalized and treated, and all three recovered uneventfully. K. kingae was confirmed in one patient and suspected in the other two.

Surveillance cultures taken from several day care centers before the administration of prophylactic antibiotics yielded K. kingae isolates in 4 of 11 attendees at the index facility and 5 of 12 and 1 of 15 attendees at neighboring facilities. The confirmed K. kingae isolate was the same strain as other isolates from the same day care center, but different from strains found at neighboring facilities.

All children aged 6–30 months who lived in the community started an antibiotic regimen of 20 mg/kg oral rifampin twice daily for 2 days, followed by 80 mg/kg amoxicillin twice daily for 4 days. The carrier rate was significantly reduced from 11 children (28%) to 2 children (5%) among the 40 children who completed the course of antibiotic therapy.

Dexamethasone Eases Pharyngitis

Children with streptococcal pharyngitis who were treated with dexamethasone as an add-on therapy showed significant improvement in general condition and activity levels after about 1 day, compared with 2 days for those who were treated with a placebo in a pilot study.

In addition, children who received three daily doses of dexamethasone showed significant improvement in their sore throat symptoms, whereas those who received one daily dose did not show such improvement, reported Dr. Mary-Lynn Niland and her colleagues at Ohio State University, Columbus.

Steroids have been shown to mitigate throat pain in adults with pharyngitis, and the researchers sought to assess the effects of extended dosage on symptoms in children (Pediatr. Infect. Dis. J. 2006;25:477–81).

A total of 90 children aged 4–21 years with group A beta hemolytic streptococcal pharyngitis were randomized to receive one oral daily dose of 0.6 mg/kg dexamethasone (maximum dose 10 mg), three oral daily doses of 0.6 mg/kg dexamethasone (maximum dose 10 mg), or a placebo in addition to an oral or intramuscular antibiotic.

The children were assessed by a combination of telephone interviews and symptom diaries.

Amoxicillin and Acute Otitis Media

A standard daily dose of 40–45 mg/kg per day amoxicillin is an appropriate first-line antibiotic for children with acute otitis media who have received at least three doses of the heptavalent pneumococcal conjugate vaccine, if treatment is needed, reported Dr. Jane Garbutt and her colleagues at Washington University, St. Louis.

If therapy is necessary, high-dose amoxicillin may be appropriate for unvaccinated children or for those who have received fewer than three doses of the vaccine (Pediatrics 2006;117:1087–94).

An increase in vaccination with at least three doses of heptavalent pneumococcal conjugate vaccine (PCV7) from 0% to 54% in a St. Louis community from 2001 to 2004 appeared to reduce the prevalence of Streptococcus pneumoniae isolates that were not susceptible to penicillin (NSSP), whereas the prevalence of S. pneumoniae not susceptible to amoxicillin (NSSP-A) remained low.

The investigators reviewed data from 327 children younger than 7 years old with new diagnoses of acute otitis media, otitis media with effusion, acute sinusitis, streptococcal pharyngitis, nonspecific upper respiratory tract infections, or a cough illness during the 4-year period.

The prevalence of NSSP was significantly reduced in children with any diagnosis who had received at least three doses of PCV7, compared with those who had fewer or no doses (8% vs. 20%), and no NSSP-A isolates were found among the study children who had received at least three doses of the PCV7 vaccine.

In addition, vaccination with at least three doses of PCV7 was protective for all child care attendees, but vaccination with at least one dose was not protective.

Antibiotics End K. kingae Outbreak

An outbreak of three Kingella kingae infections at a day care center was contained using prophylactic antibiotics, reported Dr. Pablo Yagupsky of Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his colleagues.

The findings confirm the susceptibility of day care populations to invasive disease. K. kingae has a particularly high carriage rate among very young children, who frequently put their hands or other objects into their mouths and spread the organisms through saliva, the investigators noted (Pediatr. Infect. Dis. J. 2006;25:526–32).

The outbreak occurred during a period of 15 days (starting on March 10, 2005), when three children aged 8–12 months who attended the same day care center showed signs of bone infection, and osteomyelitis was confirmed. All three children were hospitalized and treated, and all three recovered uneventfully. K. kingae was confirmed in one patient and suspected in the other two.

Surveillance cultures taken from several day care centers before the administration of prophylactic antibiotics yielded K. kingae isolates in 4 of 11 attendees at the index facility and 5 of 12 and 1 of 15 attendees at neighboring facilities. The confirmed K. kingae isolate was the same strain as other isolates from the same day care center, but different from strains found at neighboring facilities.

All children aged 6–30 months who lived in the community started an antibiotic regimen of 20 mg/kg oral rifampin twice daily for 2 days, followed by 80 mg/kg amoxicillin twice daily for 4 days. The carrier rate was significantly reduced from 11 children (28%) to 2 children (5%) among the 40 children who completed the course of antibiotic therapy.

Dexamethasone Eases Pharyngitis

Children with streptococcal pharyngitis who were treated with dexamethasone as an add-on therapy showed significant improvement in general condition and activity levels after about 1 day, compared with 2 days for those who were treated with a placebo in a pilot study.

In addition, children who received three daily doses of dexamethasone showed significant improvement in their sore throat symptoms, whereas those who received one daily dose did not show such improvement, reported Dr. Mary-Lynn Niland and her colleagues at Ohio State University, Columbus.

Steroids have been shown to mitigate throat pain in adults with pharyngitis, and the researchers sought to assess the effects of extended dosage on symptoms in children (Pediatr. Infect. Dis. J. 2006;25:477–81).

A total of 90 children aged 4–21 years with group A beta hemolytic streptococcal pharyngitis were randomized to receive one oral daily dose of 0.6 mg/kg dexamethasone (maximum dose 10 mg), three oral daily doses of 0.6 mg/kg dexamethasone (maximum dose 10 mg), or a placebo in addition to an oral or intramuscular antibiotic.

The children were assessed by a combination of telephone interviews and symptom diaries.

There were fewer influenza-associated deaths among U.S. children during last year's season, reported the Centers for Disease Control and Prevention.

During last year's flu season (from Oct. 2, 2005, to June 3, 2006), 35 deaths were reported among children aged less than 18 years, which were linked to laboratory-confirmed influenza infections from 13 states.

A total of 153 laboratory-confirmed influenza-associated deaths in children were reported during the 2003–2004 influenza season (N. Engl. J. Med. 2005;353:2559–67).

Of the 31 children for whom the type of virus was known this season, 23 were infected with the influenza A virus and 8 were infected with the influenza B virus. A total of 11 deaths (31.4%) occurred in children aged 6–23 months, 4 (11.4%) in children younger than 6 months of age, 4 (11.4%) in children aged 2–4 years, and 16 (45.7%) in children aged 5–17 years.

Pediatric hospitalizations with lab-confirmed influenza infections were monitored in two networks.

The pediatric hospitalization rates from last year's flu season showed an overall rate of 1.21/10,000 children aged 0–17 years, based on preliminary data from the Emerging Infections Program. When broken down into younger and older age groups, the rates were 2.76/10,000 among children aged 0–5 years and 0.38/10,000 among those aged 5–17 years.

Furthermore, the laboratory-confirmed influenza-associated hospitalization rate was 5.4/10,000 children for children aged 0–4 years, based on preliminary data from the New Vaccine Surveillance Network.

The formulation for the 2006–2007 influenza vaccine calls for A (H3N2) and B strains that differ from last year's version, based on analyses of recently isolated flu viruses, epidemiologic data, and postvaccination serologic studies in humans.

Vaccine manufacturers should include the A/New Caledonia/20/99-like (H1N1), A/Wisconsin/67/2005-like (H3N2), and B/Malaysia/2506/2004-like viruses in formulations of the 2006–2007 influenza vaccine, according to recommendations from the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (MMWR 2006;55:648–53).

There were fewer influenza-associated deaths among U.S. children during last year's season, reported the Centers for Disease Control and Prevention.

During last year's flu season (from Oct. 2, 2005, to June 3, 2006), 35 deaths were reported among children aged less than 18 years, which were linked to laboratory-confirmed influenza infections from 13 states.

A total of 153 laboratory-confirmed influenza-associated deaths in children were reported during the 2003–2004 influenza season (N. Engl. J. Med. 2005;353:2559–67).

Of the 31 children for whom the type of virus was known this season, 23 were infected with the influenza A virus and 8 were infected with the influenza B virus. A total of 11 deaths (31.4%) occurred in children aged 6–23 months, 4 (11.4%) in children younger than 6 months of age, 4 (11.4%) in children aged 2–4 years, and 16 (45.7%) in children aged 5–17 years.

Pediatric hospitalizations with lab-confirmed influenza infections were monitored in two networks.

The pediatric hospitalization rates from last year's flu season showed an overall rate of 1.21/10,000 children aged 0–17 years, based on preliminary data from the Emerging Infections Program. When broken down into younger and older age groups, the rates were 2.76/10,000 among children aged 0–5 years and 0.38/10,000 among those aged 5–17 years.

Furthermore, the laboratory-confirmed influenza-associated hospitalization rate was 5.4/10,000 children for children aged 0–4 years, based on preliminary data from the New Vaccine Surveillance Network.

The formulation for the 2006–2007 influenza vaccine calls for A (H3N2) and B strains that differ from last year's version, based on analyses of recently isolated flu viruses, epidemiologic data, and postvaccination serologic studies in humans.

Vaccine manufacturers should include the A/New Caledonia/20/99-like (H1N1), A/Wisconsin/67/2005-like (H3N2), and B/Malaysia/2506/2004-like viruses in formulations of the 2006–2007 influenza vaccine, according to recommendations from the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (MMWR 2006;55:648–53).

There were fewer influenza-associated deaths among U.S. children during last year's season, reported the Centers for Disease Control and Prevention.

During last year's flu season (from Oct. 2, 2005, to June 3, 2006), 35 deaths were reported among children aged less than 18 years, which were linked to laboratory-confirmed influenza infections from 13 states.

A total of 153 laboratory-confirmed influenza-associated deaths in children were reported during the 2003–2004 influenza season (N. Engl. J. Med. 2005;353:2559–67).

Of the 31 children for whom the type of virus was known this season, 23 were infected with the influenza A virus and 8 were infected with the influenza B virus. A total of 11 deaths (31.4%) occurred in children aged 6–23 months, 4 (11.4%) in children younger than 6 months of age, 4 (11.4%) in children aged 2–4 years, and 16 (45.7%) in children aged 5–17 years.

Pediatric hospitalizations with lab-confirmed influenza infections were monitored in two networks.

The pediatric hospitalization rates from last year's flu season showed an overall rate of 1.21/10,000 children aged 0–17 years, based on preliminary data from the Emerging Infections Program. When broken down into younger and older age groups, the rates were 2.76/10,000 among children aged 0–5 years and 0.38/10,000 among those aged 5–17 years.

Furthermore, the laboratory-confirmed influenza-associated hospitalization rate was 5.4/10,000 children for children aged 0–4 years, based on preliminary data from the New Vaccine Surveillance Network.

The formulation for the 2006–2007 influenza vaccine calls for A (H3N2) and B strains that differ from last year's version, based on analyses of recently isolated flu viruses, epidemiologic data, and postvaccination serologic studies in humans.

Vaccine manufacturers should include the A/New Caledonia/20/99-like (H1N1), A/Wisconsin/67/2005-like (H3N2), and B/Malaysia/2506/2004-like viruses in formulations of the 2006–2007 influenza vaccine, according to recommendations from the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (MMWR 2006;55:648–53).

WASHINGTON — Despite a recommendation to prioritize 11- to 12-year-olds, distribution of the meningococcal conjugate vaccine was especially high among 18-year-olds and was evenly distributed among 11- to 17-year-olds during its first year on the market, Dr. Gregory Wallace reported at a meeting of the National Vaccine Advisory Committee.

The rationale for the recommendation was to help establish an adolescent vaccine visit, and was not generated because of an increased disease risk among 11- to 12-year-olds, explained Dr. Wallace, chief of the Vaccine Supply and Assurance Branch at the Centers for Disease Control and Prevention.

The vaccine is also recommended for adolescents entering high school who have not been previously vaccinated, as well as for college freshmen living in dorms.

Demand for the meningococcal conjugate vaccine (MCV4), marketed as Menactra, was high starting in June 2005 after the publication and promotion of the vaccination recommendations by the CDC's Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians.

The demand was initially highest for 18-year-olds, and the peak months were June and July 2005. The high demand then decreased during the fall of 2005, as did patients' and parents' concerns about the vaccine supply.

The overall vaccine distribution rate from March 2005 to March 2006 was approximately 10% for 11- to 17-year-olds, but nearly 16% among 18-year-olds, based on physicians' billing-claims data provided by the vaccine's manufacturer, Sanofi Pasteur USA.

About 4.2 million doses were distributed between March 2005 and March 2006. Although the manufacturer projects that 6 million doses will be available for 2006–2007, the amount currently available for the summer months of 2006 is approximately the same as last year, Dr. Wallace said.

Sanofi Pasteur expects the demand for the vaccine to exceed supply this summer. To handle the anticipated summer rush among 18-year-olds, the CDC and other organizations have recommended that physicians defer the vaccination of 11- to 12-year-olds until further notice from the manufacturer that the shortage has been resolved. The current supply projections should be sufficient to cover adolescents entering high school, dorm-dwelling college freshmen, and other high-risk groups, including military recruits and travelers to areas where the risk of meningococcal disease is high. For periodic vaccine supply updates, visit www.cdc.gov/nip/news/shortages/default.htm

WASHINGTON — Despite a recommendation to prioritize 11- to 12-year-olds, distribution of the meningococcal conjugate vaccine was especially high among 18-year-olds and was evenly distributed among 11- to 17-year-olds during its first year on the market, Dr. Gregory Wallace reported at a meeting of the National Vaccine Advisory Committee.

The rationale for the recommendation was to help establish an adolescent vaccine visit, and was not generated because of an increased disease risk among 11- to 12-year-olds, explained Dr. Wallace, chief of the Vaccine Supply and Assurance Branch at the Centers for Disease Control and Prevention.

The vaccine is also recommended for adolescents entering high school who have not been previously vaccinated, as well as for college freshmen living in dorms.

Demand for the meningococcal conjugate vaccine (MCV4), marketed as Menactra, was high starting in June 2005 after the publication and promotion of the vaccination recommendations by the CDC's Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians.

The demand was initially highest for 18-year-olds, and the peak months were June and July 2005. The high demand then decreased during the fall of 2005, as did patients' and parents' concerns about the vaccine supply.

The overall vaccine distribution rate from March 2005 to March 2006 was approximately 10% for 11- to 17-year-olds, but nearly 16% among 18-year-olds, based on physicians' billing-claims data provided by the vaccine's manufacturer, Sanofi Pasteur USA.

About 4.2 million doses were distributed between March 2005 and March 2006. Although the manufacturer projects that 6 million doses will be available for 2006–2007, the amount currently available for the summer months of 2006 is approximately the same as last year, Dr. Wallace said.

Sanofi Pasteur expects the demand for the vaccine to exceed supply this summer. To handle the anticipated summer rush among 18-year-olds, the CDC and other organizations have recommended that physicians defer the vaccination of 11- to 12-year-olds until further notice from the manufacturer that the shortage has been resolved. The current supply projections should be sufficient to cover adolescents entering high school, dorm-dwelling college freshmen, and other high-risk groups, including military recruits and travelers to areas where the risk of meningococcal disease is high. For periodic vaccine supply updates, visit www.cdc.gov/nip/news/shortages/default.htm

WASHINGTON — Despite a recommendation to prioritize 11- to 12-year-olds, distribution of the meningococcal conjugate vaccine was especially high among 18-year-olds and was evenly distributed among 11- to 17-year-olds during its first year on the market, Dr. Gregory Wallace reported at a meeting of the National Vaccine Advisory Committee.

The rationale for the recommendation was to help establish an adolescent vaccine visit, and was not generated because of an increased disease risk among 11- to 12-year-olds, explained Dr. Wallace, chief of the Vaccine Supply and Assurance Branch at the Centers for Disease Control and Prevention.

The vaccine is also recommended for adolescents entering high school who have not been previously vaccinated, as well as for college freshmen living in dorms.

Demand for the meningococcal conjugate vaccine (MCV4), marketed as Menactra, was high starting in June 2005 after the publication and promotion of the vaccination recommendations by the CDC's Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians.

The demand was initially highest for 18-year-olds, and the peak months were June and July 2005. The high demand then decreased during the fall of 2005, as did patients' and parents' concerns about the vaccine supply.

The overall vaccine distribution rate from March 2005 to March 2006 was approximately 10% for 11- to 17-year-olds, but nearly 16% among 18-year-olds, based on physicians' billing-claims data provided by the vaccine's manufacturer, Sanofi Pasteur USA.

About 4.2 million doses were distributed between March 2005 and March 2006. Although the manufacturer projects that 6 million doses will be available for 2006–2007, the amount currently available for the summer months of 2006 is approximately the same as last year, Dr. Wallace said.

Sanofi Pasteur expects the demand for the vaccine to exceed supply this summer. To handle the anticipated summer rush among 18-year-olds, the CDC and other organizations have recommended that physicians defer the vaccination of 11- to 12-year-olds until further notice from the manufacturer that the shortage has been resolved. The current supply projections should be sufficient to cover adolescents entering high school, dorm-dwelling college freshmen, and other high-risk groups, including military recruits and travelers to areas where the risk of meningococcal disease is high. For periodic vaccine supply updates, visit www.cdc.gov/nip/news/shortages/default.htm

DENVER – Depression that occurred in adults after acute myocardial infarction decreased in severity during the first 6 months after the cardiac event, but then stabilized over the next several years, Kenneth E. Freedland, Ph.D., reported in a poster presented at the annual meeting of the American Psychosomatic Society.

Dr. Freedland, a member of the psychiatry department at Washington University, St. Louis, and his colleagues reviewed data on 1,086 adults who were randomized to the usual care arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study, a multicenter trial sponsored by the National Institutes of Health that was designed to evaluate depression interventions in MI patients.

The patients' mean age was 43 years, 44% were female, and 35% were minorities. In addition, 55% were high school graduates, 19% were college graduates, and 26% had less than a high school education. About 60% of the patients had a history of major depression before the MI.

The patients completed a Beck Depression Inventory (BDI) at the start of the study, and again at 6-month intervals for an average follow-up period of 26 months. The average baseline BDI score was 15.3; baseline BDI scores were lowest among older patients, non-Hispanic white patients, and patients without a history of major depression, and highest among women and patients who were taking antidepressants.

Antidepressant use was associated with worse depression in the overall ENRICHD study, so its impact in this analysis must be interpreted with caution, the investigators noted.

Overall, the severity of depression decreased during the first 6 months after the MI, but depression scores then stabilized during the follow-up period, which lasted as long as 4 years for some patients. The average decrease in BDI score was −0.85 during months 0–6, compared with −0.07 during months 6–54.

Female gender, minority status, younger age, and lower levels of education were significantly associated with higher levels of depression immediately after MI, but younger female patients showed the fastest improvements in depressive symptoms over time. Additional analysis is needed to determine patterns among these subgroups, the researchers noted.

DENVER – Depression that occurred in adults after acute myocardial infarction decreased in severity during the first 6 months after the cardiac event, but then stabilized over the next several years, Kenneth E. Freedland, Ph.D., reported in a poster presented at the annual meeting of the American Psychosomatic Society.

Dr. Freedland, a member of the psychiatry department at Washington University, St. Louis, and his colleagues reviewed data on 1,086 adults who were randomized to the usual care arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study, a multicenter trial sponsored by the National Institutes of Health that was designed to evaluate depression interventions in MI patients.

The patients' mean age was 43 years, 44% were female, and 35% were minorities. In addition, 55% were high school graduates, 19% were college graduates, and 26% had less than a high school education. About 60% of the patients had a history of major depression before the MI.

The patients completed a Beck Depression Inventory (BDI) at the start of the study, and again at 6-month intervals for an average follow-up period of 26 months. The average baseline BDI score was 15.3; baseline BDI scores were lowest among older patients, non-Hispanic white patients, and patients without a history of major depression, and highest among women and patients who were taking antidepressants.

Antidepressant use was associated with worse depression in the overall ENRICHD study, so its impact in this analysis must be interpreted with caution, the investigators noted.

Overall, the severity of depression decreased during the first 6 months after the MI, but depression scores then stabilized during the follow-up period, which lasted as long as 4 years for some patients. The average decrease in BDI score was −0.85 during months 0–6, compared with −0.07 during months 6–54.

Female gender, minority status, younger age, and lower levels of education were significantly associated with higher levels of depression immediately after MI, but younger female patients showed the fastest improvements in depressive symptoms over time. Additional analysis is needed to determine patterns among these subgroups, the researchers noted.

DENVER – Depression that occurred in adults after acute myocardial infarction decreased in severity during the first 6 months after the cardiac event, but then stabilized over the next several years, Kenneth E. Freedland, Ph.D., reported in a poster presented at the annual meeting of the American Psychosomatic Society.

Dr. Freedland, a member of the psychiatry department at Washington University, St. Louis, and his colleagues reviewed data on 1,086 adults who were randomized to the usual care arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study, a multicenter trial sponsored by the National Institutes of Health that was designed to evaluate depression interventions in MI patients.

The patients' mean age was 43 years, 44% were female, and 35% were minorities. In addition, 55% were high school graduates, 19% were college graduates, and 26% had less than a high school education. About 60% of the patients had a history of major depression before the MI.

The patients completed a Beck Depression Inventory (BDI) at the start of the study, and again at 6-month intervals for an average follow-up period of 26 months. The average baseline BDI score was 15.3; baseline BDI scores were lowest among older patients, non-Hispanic white patients, and patients without a history of major depression, and highest among women and patients who were taking antidepressants.

Antidepressant use was associated with worse depression in the overall ENRICHD study, so its impact in this analysis must be interpreted with caution, the investigators noted.

Overall, the severity of depression decreased during the first 6 months after the MI, but depression scores then stabilized during the follow-up period, which lasted as long as 4 years for some patients. The average decrease in BDI score was −0.85 during months 0–6, compared with −0.07 during months 6–54.

Female gender, minority status, younger age, and lower levels of education were significantly associated with higher levels of depression immediately after MI, but younger female patients showed the fastest improvements in depressive symptoms over time. Additional analysis is needed to determine patterns among these subgroups, the researchers noted.

WASHINGTON — Retroperitoneal dissection and uterine artery occlusion offer a successful approach to laparoscopic hysterectomy in morbidly obese patients, Dr. Jessica M. Vaught and her associates reported in a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The option to perform a laparoscopic hysterectomy can spare morbidly obese women the potential morbidity associated with an abdominal procedure, the investigators wrote.

Dr. Vaught and her colleagues at George Washington University Medical Center in Annapolis, Md., reviewed 186 laparoscopic hysterectomies performed by the same surgeon at a teaching hospital. Of these, 84 patients qualified as morbidly obese, with a body mass index ranging from 35 to 58 kg/m

Overall, the average operating time was 98 minutes, with an average estimated blood loss of 230 mL. Uterine weight ranged from 41 to 2,032 g, with an average of 426 g.

Complications included blood transfusions required by two patients, readmission for a pelvic hematoma in one patient, and an intestinal obstruction in one patient that required a 3-day hospital stay. The average hospital stay was 1.2 days.

None of the patients experienced vascular, bowel, or lower urinary tract injuries. More than half (55%) of the patients had undergone prior abdominal surgery, and nine had a laparoscopic pelvic node dissection concurrently with the hysterectomy.

WASHINGTON — Retroperitoneal dissection and uterine artery occlusion offer a successful approach to laparoscopic hysterectomy in morbidly obese patients, Dr. Jessica M. Vaught and her associates reported in a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The option to perform a laparoscopic hysterectomy can spare morbidly obese women the potential morbidity associated with an abdominal procedure, the investigators wrote.

Dr. Vaught and her colleagues at George Washington University Medical Center in Annapolis, Md., reviewed 186 laparoscopic hysterectomies performed by the same surgeon at a teaching hospital. Of these, 84 patients qualified as morbidly obese, with a body mass index ranging from 35 to 58 kg/m

Overall, the average operating time was 98 minutes, with an average estimated blood loss of 230 mL. Uterine weight ranged from 41 to 2,032 g, with an average of 426 g.

Complications included blood transfusions required by two patients, readmission for a pelvic hematoma in one patient, and an intestinal obstruction in one patient that required a 3-day hospital stay. The average hospital stay was 1.2 days.

None of the patients experienced vascular, bowel, or lower urinary tract injuries. More than half (55%) of the patients had undergone prior abdominal surgery, and nine had a laparoscopic pelvic node dissection concurrently with the hysterectomy.

WASHINGTON — Retroperitoneal dissection and uterine artery occlusion offer a successful approach to laparoscopic hysterectomy in morbidly obese patients, Dr. Jessica M. Vaught and her associates reported in a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The option to perform a laparoscopic hysterectomy can spare morbidly obese women the potential morbidity associated with an abdominal procedure, the investigators wrote.

Dr. Vaught and her colleagues at George Washington University Medical Center in Annapolis, Md., reviewed 186 laparoscopic hysterectomies performed by the same surgeon at a teaching hospital. Of these, 84 patients qualified as morbidly obese, with a body mass index ranging from 35 to 58 kg/m

Overall, the average operating time was 98 minutes, with an average estimated blood loss of 230 mL. Uterine weight ranged from 41 to 2,032 g, with an average of 426 g.

Complications included blood transfusions required by two patients, readmission for a pelvic hematoma in one patient, and an intestinal obstruction in one patient that required a 3-day hospital stay. The average hospital stay was 1.2 days.

None of the patients experienced vascular, bowel, or lower urinary tract injuries. More than half (55%) of the patients had undergone prior abdominal surgery, and nine had a laparoscopic pelvic node dissection concurrently with the hysterectomy.

WASHINGTON — Elevated levels of the Bcl-2 protein in urine were associated with 92% of ovarian cancers in a pilot study of 95 women, Patricia Kruk, Ph.D., said at the annual meeting of the American Association for Cancer Research.

“Ovarian cancer has the highest mortality rate among gynecologic malignancies,” said Dr. Kruk. “It is usually detected in the very late stages, because we don't have very good detection systems and the women are generally asymptomatic.”

The average amount of Bcl-2 in the urine of 36 women with ovarian cancer was more than 2 ng/mL, which was significantly greater—at least 10 times greater in most cases—than Bcl-2 levels in the urine of 21 healthy women and 38 women with benign gynecologic disease.

Urinary levels of Bcl-2 decreased up to 100% after patients had debulking surgery, noted Dr. Kruk, who heads a cancer research team at the University of South Florida in Tampa. The Bcl-2 levels remained low during the course of chemotherapy, but increased significantly among patients whose disease recurred.

In contrast, urine samples from the healthy women showed almost no measurable Bcl-2. “All the women had normal renal function, so Bcl-2 was not suggestive of renal dysfunction,” Dr. Kruk noted. Urinary levels of Bcl-2 were not related to tumor size, but increased levels of Bcl-2 were correlated with increased tumor stage and grade. In addition, only 65% of the patients with serious carcinomas were diagnosed using the standard method of blood test results for the tumor marker CA125. “We are cautiously optimistic and excited about our results,” said Dr. Kruk.

WASHINGTON — Elevated levels of the Bcl-2 protein in urine were associated with 92% of ovarian cancers in a pilot study of 95 women, Patricia Kruk, Ph.D., said at the annual meeting of the American Association for Cancer Research.

“Ovarian cancer has the highest mortality rate among gynecologic malignancies,” said Dr. Kruk. “It is usually detected in the very late stages, because we don't have very good detection systems and the women are generally asymptomatic.”

The average amount of Bcl-2 in the urine of 36 women with ovarian cancer was more than 2 ng/mL, which was significantly greater—at least 10 times greater in most cases—than Bcl-2 levels in the urine of 21 healthy women and 38 women with benign gynecologic disease.

Urinary levels of Bcl-2 decreased up to 100% after patients had debulking surgery, noted Dr. Kruk, who heads a cancer research team at the University of South Florida in Tampa. The Bcl-2 levels remained low during the course of chemotherapy, but increased significantly among patients whose disease recurred.

In contrast, urine samples from the healthy women showed almost no measurable Bcl-2. “All the women had normal renal function, so Bcl-2 was not suggestive of renal dysfunction,” Dr. Kruk noted. Urinary levels of Bcl-2 were not related to tumor size, but increased levels of Bcl-2 were correlated with increased tumor stage and grade. In addition, only 65% of the patients with serious carcinomas were diagnosed using the standard method of blood test results for the tumor marker CA125. “We are cautiously optimistic and excited about our results,” said Dr. Kruk.

WASHINGTON — Elevated levels of the Bcl-2 protein in urine were associated with 92% of ovarian cancers in a pilot study of 95 women, Patricia Kruk, Ph.D., said at the annual meeting of the American Association for Cancer Research.

“Ovarian cancer has the highest mortality rate among gynecologic malignancies,” said Dr. Kruk. “It is usually detected in the very late stages, because we don't have very good detection systems and the women are generally asymptomatic.”

The average amount of Bcl-2 in the urine of 36 women with ovarian cancer was more than 2 ng/mL, which was significantly greater—at least 10 times greater in most cases—than Bcl-2 levels in the urine of 21 healthy women and 38 women with benign gynecologic disease.

Urinary levels of Bcl-2 decreased up to 100% after patients had debulking surgery, noted Dr. Kruk, who heads a cancer research team at the University of South Florida in Tampa. The Bcl-2 levels remained low during the course of chemotherapy, but increased significantly among patients whose disease recurred.

In contrast, urine samples from the healthy women showed almost no measurable Bcl-2. “All the women had normal renal function, so Bcl-2 was not suggestive of renal dysfunction,” Dr. Kruk noted. Urinary levels of Bcl-2 were not related to tumor size, but increased levels of Bcl-2 were correlated with increased tumor stage and grade. In addition, only 65% of the patients with serious carcinomas were diagnosed using the standard method of blood test results for the tumor marker CA125. “We are cautiously optimistic and excited about our results,” said Dr. Kruk.

WASHINGTON — Women who took 2.5 mg of frovatriptan either once or twice daily for 6 days at the time of menstruation had significantly fewer—and less severe—menstrual migraines, compared with women who took a placebo, reported Dr. Marie Pinizzotto and her colleagues at Endo Pharmaceuticals.

The women on either regimen of frovatriptan also reported significantly fewer headaches in general and less functional impairment compared with the placebo group. Data from the randomized, double-blind, three-way crossover study were presented in a poster at the annual meeting of the American College of Obstetricians and Gynecologists. The study was sponsored by Vernalis Development Ltd., and Endo Pharmaceuticals Inc.

Frovatriptan has been approved by the Food and Drug Administration for the acute treatment of migraines, both with and without aura, in adults, but it has not been approved for the prophylactic prevention of migraines. The manufacturers are seeking an additional indication for the prophylactic treatment of menstrual migraines.

The patients were randomized to receive each of the two treatment regimens or a placebo over the course of three different 6-day periods from 2 days before to 4 days after the onset of menstruation.

The incidence of pure menstrual migraines, defined as migraines that occurred during the time period from 2 days before to 3 days after the onset of menstruation, was significantly lower in both frovatriptan groups, compared with placebo. These distinctive headaches occurred in 37.7% of the twice-daily frovatriptan group, compared with 51.3% of the once-daily group and 67.1% of the placebo group. The intent-to-treat analysis included 179 women aged 18 years and older with at least a 1-year history of menstrually-related migraines. The mean age was 37 years, and 82% were white. On average, the study participants had a history of migraines greater than 10 years, and the average number of migraine attacks was one per month during the year prior to the study.

Overall, moderate to severe headaches were reported by 25.3%, 32.3%, and 46% of women in the twice-daily frovatriptan, once-daily frovatriptan, and placebo groups; the incidence of functional impairment was 13.6%, 24.1%, and 35.4% in the twice-daily frovatriptan, once-daily frovatriptan, and placebo groups, respectively.

The overall symptoms of functional impairment—including light and sound sensitivity, nausea, and vomiting—were significantly reduced in women who took frovatriptan, and each of these symptoms individually were significantly reduced among patients in the twice-daily frovatriptan group, compared with the placebo group.

Adverse events included headache, nausea, dizziness, and nasopharyngitis, and the incidence of these events was similar between the two groups.

WASHINGTON — Women who took 2.5 mg of frovatriptan either once or twice daily for 6 days at the time of menstruation had significantly fewer—and less severe—menstrual migraines, compared with women who took a placebo, reported Dr. Marie Pinizzotto and her colleagues at Endo Pharmaceuticals.

The women on either regimen of frovatriptan also reported significantly fewer headaches in general and less functional impairment compared with the placebo group. Data from the randomized, double-blind, three-way crossover study were presented in a poster at the annual meeting of the American College of Obstetricians and Gynecologists. The study was sponsored by Vernalis Development Ltd., and Endo Pharmaceuticals Inc.

Frovatriptan has been approved by the Food and Drug Administration for the acute treatment of migraines, both with and without aura, in adults, but it has not been approved for the prophylactic prevention of migraines. The manufacturers are seeking an additional indication for the prophylactic treatment of menstrual migraines.

The patients were randomized to receive each of the two treatment regimens or a placebo over the course of three different 6-day periods from 2 days before to 4 days after the onset of menstruation.

The incidence of pure menstrual migraines, defined as migraines that occurred during the time period from 2 days before to 3 days after the onset of menstruation, was significantly lower in both frovatriptan groups, compared with placebo. These distinctive headaches occurred in 37.7% of the twice-daily frovatriptan group, compared with 51.3% of the once-daily group and 67.1% of the placebo group. The intent-to-treat analysis included 179 women aged 18 years and older with at least a 1-year history of menstrually-related migraines. The mean age was 37 years, and 82% were white. On average, the study participants had a history of migraines greater than 10 years, and the average number of migraine attacks was one per month during the year prior to the study.

Overall, moderate to severe headaches were reported by 25.3%, 32.3%, and 46% of women in the twice-daily frovatriptan, once-daily frovatriptan, and placebo groups; the incidence of functional impairment was 13.6%, 24.1%, and 35.4% in the twice-daily frovatriptan, once-daily frovatriptan, and placebo groups, respectively.

The overall symptoms of functional impairment—including light and sound sensitivity, nausea, and vomiting—were significantly reduced in women who took frovatriptan, and each of these symptoms individually were significantly reduced among patients in the twice-daily frovatriptan group, compared with the placebo group.

Adverse events included headache, nausea, dizziness, and nasopharyngitis, and the incidence of these events was similar between the two groups.

WASHINGTON — Women who took 2.5 mg of frovatriptan either once or twice daily for 6 days at the time of menstruation had significantly fewer—and less severe—menstrual migraines, compared with women who took a placebo, reported Dr. Marie Pinizzotto and her colleagues at Endo Pharmaceuticals.

The women on either regimen of frovatriptan also reported significantly fewer headaches in general and less functional impairment compared with the placebo group. Data from the randomized, double-blind, three-way crossover study were presented in a poster at the annual meeting of the American College of Obstetricians and Gynecologists. The study was sponsored by Vernalis Development Ltd., and Endo Pharmaceuticals Inc.

Frovatriptan has been approved by the Food and Drug Administration for the acute treatment of migraines, both with and without aura, in adults, but it has not been approved for the prophylactic prevention of migraines. The manufacturers are seeking an additional indication for the prophylactic treatment of menstrual migraines.

The patients were randomized to receive each of the two treatment regimens or a placebo over the course of three different 6-day periods from 2 days before to 4 days after the onset of menstruation.

The incidence of pure menstrual migraines, defined as migraines that occurred during the time period from 2 days before to 3 days after the onset of menstruation, was significantly lower in both frovatriptan groups, compared with placebo. These distinctive headaches occurred in 37.7% of the twice-daily frovatriptan group, compared with 51.3% of the once-daily group and 67.1% of the placebo group. The intent-to-treat analysis included 179 women aged 18 years and older with at least a 1-year history of menstrually-related migraines. The mean age was 37 years, and 82% were white. On average, the study participants had a history of migraines greater than 10 years, and the average number of migraine attacks was one per month during the year prior to the study.

Overall, moderate to severe headaches were reported by 25.3%, 32.3%, and 46% of women in the twice-daily frovatriptan, once-daily frovatriptan, and placebo groups; the incidence of functional impairment was 13.6%, 24.1%, and 35.4% in the twice-daily frovatriptan, once-daily frovatriptan, and placebo groups, respectively.

The overall symptoms of functional impairment—including light and sound sensitivity, nausea, and vomiting—were significantly reduced in women who took frovatriptan, and each of these symptoms individually were significantly reduced among patients in the twice-daily frovatriptan group, compared with the placebo group.

Adverse events included headache, nausea, dizziness, and nasopharyngitis, and the incidence of these events was similar between the two groups.

WASHINGTON — Seasonale Lo, the 91-day extended-regimen low-dose oral contraceptive, was effective and well tolerated compared with a 28-day low-dose oral contraceptive, after both 1 year and 3 years of use.

The Seasonale Lo data from a randomized, multicenter study were presented in two posters at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Andrew M. Kaunitz of the University of Florida Health Science Center in Jacksonville, Fla., monitored women aged 18–35 years who could potentially become pregnant. After 1 year, the overall cumulative failure rate of Seasonale Lo was 2.23% among 463 patients, compared with a 2.83% failure rate among 231 patients who took a traditional 28-day oral contraceptive (Levlite).

Compliance rates were high—98.1% in the Seasonale Lo group and 96.5% in the Levlite group. Among compliant patients, the Seasonale Lo failure rate was only 0.65%, compared with 4.14% among compliant Levlite patients. Although more Seasonale patients reported unscheduled bleeding days than the Levlite patients (6.1% vs. 3.3%), the number of scheduled bleeding or spotting days per cycle was approximately the same in both groups.

Breakthrough bleeding episodes were reported more frequently by the Seasonale Lo group than the Levlite group (13.8% vs. 1.3%), but the incidence of other adverse events was similar between the two groups. For example, headaches, the most common adverse event, were reported by 22% of the Seasonale Lo group and 21% of the Levlite group.

Each Seasonale Lo pill includes 0.02 mg of ethinyl estradiol and 0.1 mg of levonorgestrel. The regimen includes 84 days of active pills followed by 7 days of placebo pills. Dr. Kaunitz serves as a consultant to Barr Pharmaceuticals, the manufacturer of Seasonale, which also supported the study.

Seasonale continued to be safe and well tolerated in a subset of 161 women who participated in a 2-year extension of the study, reported Dr. David Portman of the Columbus Center for Women's Health Research in Columbus, Ohio.

Notably, the median number of unscheduled bleeding or spotting days decreased over the course of the study, from 2 days during the first cycle to 0 days by the eighth cycle. Patient exposure to the drug included 937 complete 91-day cycles. Patients reported their pill-taking, bleeding, and spotting data in electronic diaries, and they underwent clinical evaluation during quarterly visits. The overall discontinuation rates were similar to those for Seasonale Lo and Levlite in the original study, which were about 44% and 32%, respectively.

Dr. Portman serves on the speakers' bureau of Barr Pharmaceuticals.

WASHINGTON — Seasonale Lo, the 91-day extended-regimen low-dose oral contraceptive, was effective and well tolerated compared with a 28-day low-dose oral contraceptive, after both 1 year and 3 years of use.

The Seasonale Lo data from a randomized, multicenter study were presented in two posters at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Andrew M. Kaunitz of the University of Florida Health Science Center in Jacksonville, Fla., monitored women aged 18–35 years who could potentially become pregnant. After 1 year, the overall cumulative failure rate of Seasonale Lo was 2.23% among 463 patients, compared with a 2.83% failure rate among 231 patients who took a traditional 28-day oral contraceptive (Levlite).

Compliance rates were high—98.1% in the Seasonale Lo group and 96.5% in the Levlite group. Among compliant patients, the Seasonale Lo failure rate was only 0.65%, compared with 4.14% among compliant Levlite patients. Although more Seasonale patients reported unscheduled bleeding days than the Levlite patients (6.1% vs. 3.3%), the number of scheduled bleeding or spotting days per cycle was approximately the same in both groups.

Breakthrough bleeding episodes were reported more frequently by the Seasonale Lo group than the Levlite group (13.8% vs. 1.3%), but the incidence of other adverse events was similar between the two groups. For example, headaches, the most common adverse event, were reported by 22% of the Seasonale Lo group and 21% of the Levlite group.

Each Seasonale Lo pill includes 0.02 mg of ethinyl estradiol and 0.1 mg of levonorgestrel. The regimen includes 84 days of active pills followed by 7 days of placebo pills. Dr. Kaunitz serves as a consultant to Barr Pharmaceuticals, the manufacturer of Seasonale, which also supported the study.

Seasonale continued to be safe and well tolerated in a subset of 161 women who participated in a 2-year extension of the study, reported Dr. David Portman of the Columbus Center for Women's Health Research in Columbus, Ohio.

Notably, the median number of unscheduled bleeding or spotting days decreased over the course of the study, from 2 days during the first cycle to 0 days by the eighth cycle. Patient exposure to the drug included 937 complete 91-day cycles. Patients reported their pill-taking, bleeding, and spotting data in electronic diaries, and they underwent clinical evaluation during quarterly visits. The overall discontinuation rates were similar to those for Seasonale Lo and Levlite in the original study, which were about 44% and 32%, respectively.

Dr. Portman serves on the speakers' bureau of Barr Pharmaceuticals.

WASHINGTON — Seasonale Lo, the 91-day extended-regimen low-dose oral contraceptive, was effective and well tolerated compared with a 28-day low-dose oral contraceptive, after both 1 year and 3 years of use.

The Seasonale Lo data from a randomized, multicenter study were presented in two posters at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Andrew M. Kaunitz of the University of Florida Health Science Center in Jacksonville, Fla., monitored women aged 18–35 years who could potentially become pregnant. After 1 year, the overall cumulative failure rate of Seasonale Lo was 2.23% among 463 patients, compared with a 2.83% failure rate among 231 patients who took a traditional 28-day oral contraceptive (Levlite).

Compliance rates were high—98.1% in the Seasonale Lo group and 96.5% in the Levlite group. Among compliant patients, the Seasonale Lo failure rate was only 0.65%, compared with 4.14% among compliant Levlite patients. Although more Seasonale patients reported unscheduled bleeding days than the Levlite patients (6.1% vs. 3.3%), the number of scheduled bleeding or spotting days per cycle was approximately the same in both groups.

Breakthrough bleeding episodes were reported more frequently by the Seasonale Lo group than the Levlite group (13.8% vs. 1.3%), but the incidence of other adverse events was similar between the two groups. For example, headaches, the most common adverse event, were reported by 22% of the Seasonale Lo group and 21% of the Levlite group.

Each Seasonale Lo pill includes 0.02 mg of ethinyl estradiol and 0.1 mg of levonorgestrel. The regimen includes 84 days of active pills followed by 7 days of placebo pills. Dr. Kaunitz serves as a consultant to Barr Pharmaceuticals, the manufacturer of Seasonale, which also supported the study.

Seasonale continued to be safe and well tolerated in a subset of 161 women who participated in a 2-year extension of the study, reported Dr. David Portman of the Columbus Center for Women's Health Research in Columbus, Ohio.

Notably, the median number of unscheduled bleeding or spotting days decreased over the course of the study, from 2 days during the first cycle to 0 days by the eighth cycle. Patient exposure to the drug included 937 complete 91-day cycles. Patients reported their pill-taking, bleeding, and spotting data in electronic diaries, and they underwent clinical evaluation during quarterly visits. The overall discontinuation rates were similar to those for Seasonale Lo and Levlite in the original study, which were about 44% and 32%, respectively.

Dr. Portman serves on the speakers' bureau of Barr Pharmaceuticals.

WASHINGTON — Either too much or too little weight gain during pregnancy could increase the risk of neonatal intensive care unit admission and peripartum complications, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The highest quintiles of maternal weight gain during pregnancy were significantly associated with rates of NICU admission in a study of 2,784 singleton pregnancies, Dr. Teresa Tam and her colleagues, of Saint Joseph Hospital, Chicago, reported in a poster.

After adjustment for age, delivery method, and prepregnancy weight, among other factors, the medium weight gain quintiles— 22–29 pounds and 30–35 pounds—were associated with the lowest NICU transfer rates of 3.3% and 2.6%, respectively. The study did not analyze the specific outcomes that prompted the NICU transfers.

A second poster by Dr. Devendra A. Patel of Weill Cornell Medical College, New York, and colleagues found that heavier women had almost twice the rate of maternal and fetal complications as women of normal weight.

Dr. Patel found no fetal complications and 11 peripartum complications among 68 women whose BMI was less than 30 kg/m

An analysis of a larger sample while controlling for confounding variables is needed to confirm the study's validity, the investigators wrote.

WASHINGTON — Either too much or too little weight gain during pregnancy could increase the risk of neonatal intensive care unit admission and peripartum complications, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The highest quintiles of maternal weight gain during pregnancy were significantly associated with rates of NICU admission in a study of 2,784 singleton pregnancies, Dr. Teresa Tam and her colleagues, of Saint Joseph Hospital, Chicago, reported in a poster.

After adjustment for age, delivery method, and prepregnancy weight, among other factors, the medium weight gain quintiles— 22–29 pounds and 30–35 pounds—were associated with the lowest NICU transfer rates of 3.3% and 2.6%, respectively. The study did not analyze the specific outcomes that prompted the NICU transfers.

A second poster by Dr. Devendra A. Patel of Weill Cornell Medical College, New York, and colleagues found that heavier women had almost twice the rate of maternal and fetal complications as women of normal weight.

Dr. Patel found no fetal complications and 11 peripartum complications among 68 women whose BMI was less than 30 kg/m

An analysis of a larger sample while controlling for confounding variables is needed to confirm the study's validity, the investigators wrote.

WASHINGTON — Either too much or too little weight gain during pregnancy could increase the risk of neonatal intensive care unit admission and peripartum complications, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The highest quintiles of maternal weight gain during pregnancy were significantly associated with rates of NICU admission in a study of 2,784 singleton pregnancies, Dr. Teresa Tam and her colleagues, of Saint Joseph Hospital, Chicago, reported in a poster.

After adjustment for age, delivery method, and prepregnancy weight, among other factors, the medium weight gain quintiles— 22–29 pounds and 30–35 pounds—were associated with the lowest NICU transfer rates of 3.3% and 2.6%, respectively. The study did not analyze the specific outcomes that prompted the NICU transfers.

A second poster by Dr. Devendra A. Patel of Weill Cornell Medical College, New York, and colleagues found that heavier women had almost twice the rate of maternal and fetal complications as women of normal weight.

Dr. Patel found no fetal complications and 11 peripartum complications among 68 women whose BMI was less than 30 kg/m

An analysis of a larger sample while controlling for confounding variables is needed to confirm the study's validity, the investigators wrote.

WASHINGTON — Often, the best episiotomy may be no episiotomy, Dr. Lily A. Arya noted at the annual meeting of the American College of Obstetricians and Gynecologists.

That said, episiotomies are needed in some cases, and sometimes wound dehiscence requires additional repair, said Dr. Arya, a urogynecologist at the University of Pennsylvania Medical Center in Philadelphia.

The need for episiotomies remains a subject for debate. Dr. Arya cited a recent study that compared routine episiotomy, selective episiotomy, and no episiotomy, and found no significant difference in the incidence of minor lacerations or fecal incontinence (Acta Obstet. Gynecol. Scand. 2004;83:364–8).

“Sometimes, if you let nature take its course you will only end up with minor lacerations,” Dr. Arya said, although she added that she favors selective episiotomies. The surgeon's challenge lies in trying to deduce whether significant tearing might occur.

Mediolateral episiotomy has several advantages over median episiotomy if the surgeon decides to proceed, Dr. Arya said. Although the midline episiotomy involves less bleeding, pain, and dyspareunia, the median technique tends to cause more fecal incontinence and a greater risk of anal sphincter injury.

Mediolateral episiotomy, on the other hand, will not prevent tears, but it will not cause tearing, either.

The traditional strategy in dehiscence cases has been to reopen the wound and perform a secondary repair in 3–4 months.

However, the wound can be debrided and repaired almost immediately if there is no infection. “Infection from an episiotomy is extremely rare,” Dr. Arya noted. If infection is present, the wound can be debrided on an outpatient basis until all necrotic material is gone and pink, granulating tissue is achieved, and a repair can usually be performed within a week.

Closures for episiotomy dehiscence are similar to those for perineal tears, but Dr. Arya recommends incorporating some tissue from the sides of the wound to close with two layers. The repair will bring the transverse perineal muscles together.

“Make sure you don't leave gaps in the submucosa; that is what will cause a fistula,” she noted.

To minimize the patient's postoperative discomfort, Dr. Arya recommends stool softeners for 6 weeks, antibiotics for the first 48 hours, and a low-residue diet for the first 72 hours to postpone bowel movements and prevent the patient from becoming constipated.

Fecal incontinence remains a significant problem in women, and the majority of cases stem from obstetric trauma, said Dr. Najia N. Mahmoud, a colorectal surgeon at the University of Pennsylvania, Philadelphia.

Many women who present with fecal incontinence have managed for long periods of time by employing a range of coping strategies. Their tricks include avoiding travel, reducing food intake and exercise, wearing dark clothing and multiple absorbent products, and only visiting places with readily accessible bathrooms. Dr. Mahmoud's strategy for evaluating fecal incontinence starts with an examination of the patient.

“A lot of what you learn about the patient's incontinence comes from the physical exam,” she said. Unless the physical exam is confusing in some way, anal manometry and pudendal nerve testing do not add much to the diagnosis. “I don't think these are necessary for people with obvious signs of fecal incontinence.” However, endoanal ultrasound allows for an anatomic description of the injury and helps with surgical planning for patients who are good surgical candidates. Incontinence to solid stool constitutes the most common indication for surgery.

Biofeedback with a trained physical therapist can be helpful both pre- and postoperatively for patients with mild or moderate fecal incontinence (incontinence to gas or urgency), as well as for patients who aren't immediate candidates for surgery, she said.

In addition, Dr. Mahmoud said that she makes an effort to modify the patient's diet. “It's imperative that you investigate the underlying causes of diarrhea and modify the bowel movements,” she said. In many cases, the incontinence will resolve once diarrhea is under control.

Most people don't consume as much fiber as they think they do, so Dr. Mahmoud prescribes a daily dose of fiber wafers with 6 ounces of water for incontinent patients or those with soft or loose bowel movements. The consistent fiber consumption seems to result in a better-formed stool and improved continence, and provides a good adjuvant therapy to either conservative strategies like biofeedback or surgical solutions such as sphincter reconstruction.

Surgery is rarely necessary for patients with incontinence to liquid stool and flatulence, she emphasized.

An overlapping sphincteroplasty is an appropriate surgical plan for patients with sphincter defects who are consistently incontinent to solid stool. The technique is generally successful; data from a 2000 study of 40 patients showed an 81% success rate immediately following surgery, and a 51% success rate after 40 months.

To optimize outcomes, be sure to address patient expectations, and remind them that the return to normal muscle and sphincter function is slow, and can take up to 3 months. Kegel exercises can help strengthen the muscles during recovery, she said. Infection rates are low—less than 8%-in overlapping sphincteroplasty patients, but the presence of infection increases the failure rate.

The most significant factor in a successful sphincter repair is its durability, and constipation must be prevented to preserve the intactness of the repair in the immediate postoperative period.

“Constipation is the enemy of a sphincter repair in the first week or two,” Dr. Mahmoud said. She uses a combination of treatments including milk of magnesia, fiber, and stool softeners, and mineral oil, to help steer patients through recovery.

WASHINGTON — Often, the best episiotomy may be no episiotomy, Dr. Lily A. Arya noted at the annual meeting of the American College of Obstetricians and Gynecologists.

That said, episiotomies are needed in some cases, and sometimes wound dehiscence requires additional repair, said Dr. Arya, a urogynecologist at the University of Pennsylvania Medical Center in Philadelphia.

The need for episiotomies remains a subject for debate. Dr. Arya cited a recent study that compared routine episiotomy, selective episiotomy, and no episiotomy, and found no significant difference in the incidence of minor lacerations or fecal incontinence (Acta Obstet. Gynecol. Scand. 2004;83:364–8).

“Sometimes, if you let nature take its course you will only end up with minor lacerations,” Dr. Arya said, although she added that she favors selective episiotomies. The surgeon's challenge lies in trying to deduce whether significant tearing might occur.

Mediolateral episiotomy has several advantages over median episiotomy if the surgeon decides to proceed, Dr. Arya said. Although the midline episiotomy involves less bleeding, pain, and dyspareunia, the median technique tends to cause more fecal incontinence and a greater risk of anal sphincter injury.

Mediolateral episiotomy, on the other hand, will not prevent tears, but it will not cause tearing, either.

The traditional strategy in dehiscence cases has been to reopen the wound and perform a secondary repair in 3–4 months.

However, the wound can be debrided and repaired almost immediately if there is no infection. “Infection from an episiotomy is extremely rare,” Dr. Arya noted. If infection is present, the wound can be debrided on an outpatient basis until all necrotic material is gone and pink, granulating tissue is achieved, and a repair can usually be performed within a week.

Closures for episiotomy dehiscence are similar to those for perineal tears, but Dr. Arya recommends incorporating some tissue from the sides of the wound to close with two layers. The repair will bring the transverse perineal muscles together.

“Make sure you don't leave gaps in the submucosa; that is what will cause a fistula,” she noted.

To minimize the patient's postoperative discomfort, Dr. Arya recommends stool softeners for 6 weeks, antibiotics for the first 48 hours, and a low-residue diet for the first 72 hours to postpone bowel movements and prevent the patient from becoming constipated.

Fecal incontinence remains a significant problem in women, and the majority of cases stem from obstetric trauma, said Dr. Najia N. Mahmoud, a colorectal surgeon at the University of Pennsylvania, Philadelphia.

Many women who present with fecal incontinence have managed for long periods of time by employing a range of coping strategies. Their tricks include avoiding travel, reducing food intake and exercise, wearing dark clothing and multiple absorbent products, and only visiting places with readily accessible bathrooms. Dr. Mahmoud's strategy for evaluating fecal incontinence starts with an examination of the patient.

“A lot of what you learn about the patient's incontinence comes from the physical exam,” she said. Unless the physical exam is confusing in some way, anal manometry and pudendal nerve testing do not add much to the diagnosis. “I don't think these are necessary for people with obvious signs of fecal incontinence.” However, endoanal ultrasound allows for an anatomic description of the injury and helps with surgical planning for patients who are good surgical candidates. Incontinence to solid stool constitutes the most common indication for surgery.

Biofeedback with a trained physical therapist can be helpful both pre- and postoperatively for patients with mild or moderate fecal incontinence (incontinence to gas or urgency), as well as for patients who aren't immediate candidates for surgery, she said.

In addition, Dr. Mahmoud said that she makes an effort to modify the patient's diet. “It's imperative that you investigate the underlying causes of diarrhea and modify the bowel movements,” she said. In many cases, the incontinence will resolve once diarrhea is under control.

Most people don't consume as much fiber as they think they do, so Dr. Mahmoud prescribes a daily dose of fiber wafers with 6 ounces of water for incontinent patients or those with soft or loose bowel movements. The consistent fiber consumption seems to result in a better-formed stool and improved continence, and provides a good adjuvant therapy to either conservative strategies like biofeedback or surgical solutions such as sphincter reconstruction.

Surgery is rarely necessary for patients with incontinence to liquid stool and flatulence, she emphasized.

An overlapping sphincteroplasty is an appropriate surgical plan for patients with sphincter defects who are consistently incontinent to solid stool. The technique is generally successful; data from a 2000 study of 40 patients showed an 81% success rate immediately following surgery, and a 51% success rate after 40 months.

To optimize outcomes, be sure to address patient expectations, and remind them that the return to normal muscle and sphincter function is slow, and can take up to 3 months. Kegel exercises can help strengthen the muscles during recovery, she said. Infection rates are low—less than 8%-in overlapping sphincteroplasty patients, but the presence of infection increases the failure rate.

The most significant factor in a successful sphincter repair is its durability, and constipation must be prevented to preserve the intactness of the repair in the immediate postoperative period.

“Constipation is the enemy of a sphincter repair in the first week or two,” Dr. Mahmoud said. She uses a combination of treatments including milk of magnesia, fiber, and stool softeners, and mineral oil, to help steer patients through recovery.

WASHINGTON — Often, the best episiotomy may be no episiotomy, Dr. Lily A. Arya noted at the annual meeting of the American College of Obstetricians and Gynecologists.

That said, episiotomies are needed in some cases, and sometimes wound dehiscence requires additional repair, said Dr. Arya, a urogynecologist at the University of Pennsylvania Medical Center in Philadelphia.

The need for episiotomies remains a subject for debate. Dr. Arya cited a recent study that compared routine episiotomy, selective episiotomy, and no episiotomy, and found no significant difference in the incidence of minor lacerations or fecal incontinence (Acta Obstet. Gynecol. Scand. 2004;83:364–8).

“Sometimes, if you let nature take its course you will only end up with minor lacerations,” Dr. Arya said, although she added that she favors selective episiotomies. The surgeon's challenge lies in trying to deduce whether significant tearing might occur.

Mediolateral episiotomy has several advantages over median episiotomy if the surgeon decides to proceed, Dr. Arya said. Although the midline episiotomy involves less bleeding, pain, and dyspareunia, the median technique tends to cause more fecal incontinence and a greater risk of anal sphincter injury.

Mediolateral episiotomy, on the other hand, will not prevent tears, but it will not cause tearing, either.

The traditional strategy in dehiscence cases has been to reopen the wound and perform a secondary repair in 3–4 months.

However, the wound can be debrided and repaired almost immediately if there is no infection. “Infection from an episiotomy is extremely rare,” Dr. Arya noted. If infection is present, the wound can be debrided on an outpatient basis until all necrotic material is gone and pink, granulating tissue is achieved, and a repair can usually be performed within a week.

Closures for episiotomy dehiscence are similar to those for perineal tears, but Dr. Arya recommends incorporating some tissue from the sides of the wound to close with two layers. The repair will bring the transverse perineal muscles together.

“Make sure you don't leave gaps in the submucosa; that is what will cause a fistula,” she noted.

To minimize the patient's postoperative discomfort, Dr. Arya recommends stool softeners for 6 weeks, antibiotics for the first 48 hours, and a low-residue diet for the first 72 hours to postpone bowel movements and prevent the patient from becoming constipated.

Fecal incontinence remains a significant problem in women, and the majority of cases stem from obstetric trauma, said Dr. Najia N. Mahmoud, a colorectal surgeon at the University of Pennsylvania, Philadelphia.

Many women who present with fecal incontinence have managed for long periods of time by employing a range of coping strategies. Their tricks include avoiding travel, reducing food intake and exercise, wearing dark clothing and multiple absorbent products, and only visiting places with readily accessible bathrooms. Dr. Mahmoud's strategy for evaluating fecal incontinence starts with an examination of the patient.

“A lot of what you learn about the patient's incontinence comes from the physical exam,” she said. Unless the physical exam is confusing in some way, anal manometry and pudendal nerve testing do not add much to the diagnosis. “I don't think these are necessary for people with obvious signs of fecal incontinence.” However, endoanal ultrasound allows for an anatomic description of the injury and helps with surgical planning for patients who are good surgical candidates. Incontinence to solid stool constitutes the most common indication for surgery.

Biofeedback with a trained physical therapist can be helpful both pre- and postoperatively for patients with mild or moderate fecal incontinence (incontinence to gas or urgency), as well as for patients who aren't immediate candidates for surgery, she said.

In addition, Dr. Mahmoud said that she makes an effort to modify the patient's diet. “It's imperative that you investigate the underlying causes of diarrhea and modify the bowel movements,” she said. In many cases, the incontinence will resolve once diarrhea is under control.

Most people don't consume as much fiber as they think they do, so Dr. Mahmoud prescribes a daily dose of fiber wafers with 6 ounces of water for incontinent patients or those with soft or loose bowel movements. The consistent fiber consumption seems to result in a better-formed stool and improved continence, and provides a good adjuvant therapy to either conservative strategies like biofeedback or surgical solutions such as sphincter reconstruction.

Surgery is rarely necessary for patients with incontinence to liquid stool and flatulence, she emphasized.

An overlapping sphincteroplasty is an appropriate surgical plan for patients with sphincter defects who are consistently incontinent to solid stool. The technique is generally successful; data from a 2000 study of 40 patients showed an 81% success rate immediately following surgery, and a 51% success rate after 40 months.

To optimize outcomes, be sure to address patient expectations, and remind them that the return to normal muscle and sphincter function is slow, and can take up to 3 months. Kegel exercises can help strengthen the muscles during recovery, she said. Infection rates are low—less than 8%-in overlapping sphincteroplasty patients, but the presence of infection increases the failure rate.

The most significant factor in a successful sphincter repair is its durability, and constipation must be prevented to preserve the intactness of the repair in the immediate postoperative period.

“Constipation is the enemy of a sphincter repair in the first week or two,” Dr. Mahmoud said. She uses a combination of treatments including milk of magnesia, fiber, and stool softeners, and mineral oil, to help steer patients through recovery.