Heidi Splete

The response to the pandemic influenza A(H1N1) virus by the governments and public health officials of Mexico City and New York City in the spring of 2009 reveals successful strategies, but also points to issues that need to be addressed, according to a report from the Centers for Disease Control and Prevention.

“In each case, advance planning laid the foundation for enhanced surveillance and a generally effective response, made possible by an extensive public communications campaign and effective political leadership,” wrote Dr. David M. Bell of the CDC, and his associates.

The researchers summarized the responses of Mexico City and New York City to the H1N1 virus in spring 2009 (Emerg. Infect. Dis. 2009 [doi: 10.3201/eid1512.091232]).

“These megacities may not be representative of cities in low-income countries, which face more daunting problems,” the researchers noted.

After the novel H1N1 virus was identified on April 23, 2009, Mexico City followed a pandemic influenza preparedness plan that had been developed for any virus that originated outside Mexico. Efforts to decrease the spread of the virus included an intense media campaign encouraging people to stay home if they were sick and to avoid close contact such as hugging or kissing in greeting.

“Early in the epidemic, the federal government released antiviral drugs from the national strategic reserve and controlled their distribution,” Dr. Bell and his colleagues wrote.

The government successfully introduced a mass media campaign that addressed Mexico City's diverse population and range of literacy rates. In addition, it mobilized private businesses, such as grocery stories and pharmacies, to deliver health messages. The Ministry of Health also used text messages and e-mails to convey public health messages.

The closure of thousands of businesses in Mexico City and throughout Mexico is estimated to have cost the country more than $2.3 billion, and large gatherings such as sporting events were canceled or postponed, the researchers said.

Despite these costs, the researchers concluded that Mexico City's preparations paid off. “The preexisting pandemic plan and planning process facilitated collaboration, decision making, and rapid development of a communications campaign,” they said. But the emergency of the pandemic illustrated several areas in need of improvement, including a limited capacity of laboratories to handle tests and a lack of criteria for reopening schools that closed because of the outbreak.

In New York City, 77% of emergency departments collect electronic information from more than 90% of patient visits. “During spring 2009, these systems were essential for real-time monitoring of the pandemic in NYC,” allowing public health officials to track the spread of the virus through the city, the investigators emphasized.

The New York City government kept the public informed during the spring 2009 H1N1 outbreak with press conferences in both English and Spanish, and a government information hotline staffed with live operators answered 98% of calls within 30 seconds, the researchers said. About 50 schools in New York City closed for approximately 1 week.

Unlike Mexico City, New York City did not distribute antiviral drugs from the emergency stockpile because “normal distribution channels sufficed,” Dr. Bell and his associates said, but emergency plans called for the distribution of antivirals from the stockpile via hospitals, public clinics, and community health centers if necessary.

Decision making based on flu severity in New York City proved challenging, given that the case-fatality ratio was unknown. Other challenges included deciding when and whether to close and reopen schools and how to keep children from gathering in groups elsewhere when schools were closed.

In response to the surge in emergency department visits from individuals with flulike symptoms, New York City hospitals were able to plan for additional care sites to handle the expected surge in cases of influenza-like illness in the fall and winter of 2009, the researchers said.

Overall, they concluded that the early responses of Mexico City and New York City to the H1N1 virus outbreak were promising.

The problems that did occur would likely have been worse if the disease had been more severe or if schools and businesses had remained closed for longer periods, they wrote. More research is needed to continue to identify best practices for pandemic situations in cities.

Advance planning led to a generally effective response to H1N1 outbreaks.

Source ©CDC

The response to the pandemic influenza A(H1N1) virus by the governments and public health officials of Mexico City and New York City in the spring of 2009 reveals successful strategies, but also points to issues that need to be addressed, according to a report from the Centers for Disease Control and Prevention.

“In each case, advance planning laid the foundation for enhanced surveillance and a generally effective response, made possible by an extensive public communications campaign and effective political leadership,” wrote Dr. David M. Bell of the CDC, and his associates.

The researchers summarized the responses of Mexico City and New York City to the H1N1 virus in spring 2009 (Emerg. Infect. Dis. 2009 [doi: 10.3201/eid1512.091232]).

“These megacities may not be representative of cities in low-income countries, which face more daunting problems,” the researchers noted.

After the novel H1N1 virus was identified on April 23, 2009, Mexico City followed a pandemic influenza preparedness plan that had been developed for any virus that originated outside Mexico. Efforts to decrease the spread of the virus included an intense media campaign encouraging people to stay home if they were sick and to avoid close contact such as hugging or kissing in greeting.

“Early in the epidemic, the federal government released antiviral drugs from the national strategic reserve and controlled their distribution,” Dr. Bell and his colleagues wrote.

The government successfully introduced a mass media campaign that addressed Mexico City's diverse population and range of literacy rates. In addition, it mobilized private businesses, such as grocery stories and pharmacies, to deliver health messages. The Ministry of Health also used text messages and e-mails to convey public health messages.

The closure of thousands of businesses in Mexico City and throughout Mexico is estimated to have cost the country more than $2.3 billion, and large gatherings such as sporting events were canceled or postponed, the researchers said.

Despite these costs, the researchers concluded that Mexico City's preparations paid off. “The preexisting pandemic plan and planning process facilitated collaboration, decision making, and rapid development of a communications campaign,” they said. But the emergency of the pandemic illustrated several areas in need of improvement, including a limited capacity of laboratories to handle tests and a lack of criteria for reopening schools that closed because of the outbreak.

In New York City, 77% of emergency departments collect electronic information from more than 90% of patient visits. “During spring 2009, these systems were essential for real-time monitoring of the pandemic in NYC,” allowing public health officials to track the spread of the virus through the city, the investigators emphasized.

The New York City government kept the public informed during the spring 2009 H1N1 outbreak with press conferences in both English and Spanish, and a government information hotline staffed with live operators answered 98% of calls within 30 seconds, the researchers said. About 50 schools in New York City closed for approximately 1 week.

Unlike Mexico City, New York City did not distribute antiviral drugs from the emergency stockpile because “normal distribution channels sufficed,” Dr. Bell and his associates said, but emergency plans called for the distribution of antivirals from the stockpile via hospitals, public clinics, and community health centers if necessary.

Decision making based on flu severity in New York City proved challenging, given that the case-fatality ratio was unknown. Other challenges included deciding when and whether to close and reopen schools and how to keep children from gathering in groups elsewhere when schools were closed.

In response to the surge in emergency department visits from individuals with flulike symptoms, New York City hospitals were able to plan for additional care sites to handle the expected surge in cases of influenza-like illness in the fall and winter of 2009, the researchers said.

Overall, they concluded that the early responses of Mexico City and New York City to the H1N1 virus outbreak were promising.

The problems that did occur would likely have been worse if the disease had been more severe or if schools and businesses had remained closed for longer periods, they wrote. More research is needed to continue to identify best practices for pandemic situations in cities.

Advance planning led to a generally effective response to H1N1 outbreaks.

Source ©CDC

The response to the pandemic influenza A(H1N1) virus by the governments and public health officials of Mexico City and New York City in the spring of 2009 reveals successful strategies, but also points to issues that need to be addressed, according to a report from the Centers for Disease Control and Prevention.

“In each case, advance planning laid the foundation for enhanced surveillance and a generally effective response, made possible by an extensive public communications campaign and effective political leadership,” wrote Dr. David M. Bell of the CDC, and his associates.

The researchers summarized the responses of Mexico City and New York City to the H1N1 virus in spring 2009 (Emerg. Infect. Dis. 2009 [doi: 10.3201/eid1512.091232]).

“These megacities may not be representative of cities in low-income countries, which face more daunting problems,” the researchers noted.

After the novel H1N1 virus was identified on April 23, 2009, Mexico City followed a pandemic influenza preparedness plan that had been developed for any virus that originated outside Mexico. Efforts to decrease the spread of the virus included an intense media campaign encouraging people to stay home if they were sick and to avoid close contact such as hugging or kissing in greeting.

“Early in the epidemic, the federal government released antiviral drugs from the national strategic reserve and controlled their distribution,” Dr. Bell and his colleagues wrote.

The government successfully introduced a mass media campaign that addressed Mexico City's diverse population and range of literacy rates. In addition, it mobilized private businesses, such as grocery stories and pharmacies, to deliver health messages. The Ministry of Health also used text messages and e-mails to convey public health messages.

The closure of thousands of businesses in Mexico City and throughout Mexico is estimated to have cost the country more than $2.3 billion, and large gatherings such as sporting events were canceled or postponed, the researchers said.

Despite these costs, the researchers concluded that Mexico City's preparations paid off. “The preexisting pandemic plan and planning process facilitated collaboration, decision making, and rapid development of a communications campaign,” they said. But the emergency of the pandemic illustrated several areas in need of improvement, including a limited capacity of laboratories to handle tests and a lack of criteria for reopening schools that closed because of the outbreak.

In New York City, 77% of emergency departments collect electronic information from more than 90% of patient visits. “During spring 2009, these systems were essential for real-time monitoring of the pandemic in NYC,” allowing public health officials to track the spread of the virus through the city, the investigators emphasized.

The New York City government kept the public informed during the spring 2009 H1N1 outbreak with press conferences in both English and Spanish, and a government information hotline staffed with live operators answered 98% of calls within 30 seconds, the researchers said. About 50 schools in New York City closed for approximately 1 week.

Unlike Mexico City, New York City did not distribute antiviral drugs from the emergency stockpile because “normal distribution channels sufficed,” Dr. Bell and his associates said, but emergency plans called for the distribution of antivirals from the stockpile via hospitals, public clinics, and community health centers if necessary.

Decision making based on flu severity in New York City proved challenging, given that the case-fatality ratio was unknown. Other challenges included deciding when and whether to close and reopen schools and how to keep children from gathering in groups elsewhere when schools were closed.

In response to the surge in emergency department visits from individuals with flulike symptoms, New York City hospitals were able to plan for additional care sites to handle the expected surge in cases of influenza-like illness in the fall and winter of 2009, the researchers said.

Overall, they concluded that the early responses of Mexico City and New York City to the H1N1 virus outbreak were promising.

The problems that did occur would likely have been worse if the disease had been more severe or if schools and businesses had remained closed for longer periods, they wrote. More research is needed to continue to identify best practices for pandemic situations in cities.

Advance planning led to a generally effective response to H1N1 outbreaks.

Source ©CDC

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9–26 years.

ACIP made the recommendation at its annual fall meeting.

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18.

But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations for the use of the bivalent vaccine.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate.

Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference. The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable.

The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11–12 years and recommended second and third doses at 1–2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses.

The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13–26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that postmarketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS), including a study to look at pregnancy outcomes after vaccination with the bivalent vaccine.

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

For the latest information on ACIP vaccine recommendations, visit cdc.gov/vaccines/recs/acip.

Unlike the quadrivalent vaccine, the bivalent vaccine is not designed to prevent genital warts, Dr. Lauri Markowitz said.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9–26 years.

ACIP made the recommendation at its annual fall meeting.

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18.

But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations for the use of the bivalent vaccine.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate.

Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference. The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable.

The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11–12 years and recommended second and third doses at 1–2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses.

The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13–26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that postmarketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS), including a study to look at pregnancy outcomes after vaccination with the bivalent vaccine.

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

For the latest information on ACIP vaccine recommendations, visit cdc.gov/vaccines/recs/acip.

Unlike the quadrivalent vaccine, the bivalent vaccine is not designed to prevent genital warts, Dr. Lauri Markowitz said.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9–26 years.

ACIP made the recommendation at its annual fall meeting.

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18.

But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations for the use of the bivalent vaccine.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate.

Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference. The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable.

The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11–12 years and recommended second and third doses at 1–2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses.

The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13–26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that postmarketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS), including a study to look at pregnancy outcomes after vaccination with the bivalent vaccine.

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

For the latest information on ACIP vaccine recommendations, visit cdc.gov/vaccines/recs/acip.

Unlike the quadrivalent vaccine, the bivalent vaccine is not designed to prevent genital warts, Dr. Lauri Markowitz said.

Source Parker Smith/Elsevier Global Medical News

Collection of an oseltamivir-resistant pandemic influenza A(H1N1) isolate in a 59-year-old man taking the drug prophylactically underscores the need to limit antiviral prophylaxis of pandemic flu, according to correspondence published online in the New England Journal of Medicine on Nov. 11.

Oseltamivir was prescribed to all household contacts of the man's 13-year-old son (the index patient), whose infection was confirmed by a reverse-transcriptase polymerase-chain reaction test. The patient's father, mother, and sisters (aged 15 and 18 years) were prescribed 75 mg oseltamivir once daily for 10 days as prophylaxis.

The patient's father was taking 5 mg prednisone daily and had chronic obstructive pulmonary disease. The father developed flulike symptoms approximately 24 hours after prophylaxis began.

On prophylaxis day 8, the father was seen by his physician for a persistent cough, and an H1N1-positive nasopharyngeal aspirate was collected. After an uneventful course of illness, a second sample was negative, the investigators wrote. The case was reported by Mariana Baz, M.Sc., of the Centre Hospitalier Universitaire de Québec, and colleagues (N. Engl. J. Med. 2009 Nov. 11 [Epub doi: 10.1056/NEJMC0910060]).

The sample from the father showed a neuraminidase mutation (H275Y) that has been associated with oseltamivir resistance in seasonal H1N1

"We hypothesize that the presence of subtherapeutic levels of oseltamivir at a time when viral replication had already begun was an important factor that led to the emergence of the resistant virus in the father of our index patient," they wrote.

The case supports the need to limit prophylactic treatment with oseltamivir in persons who have already been exposed to the H1N1 virus, the investigators noted. They also suggested that patients receiving once-daily antiviral prophylaxis convert to a twice-daily regimen as soon as they develop flulike symptoms.

A conflict of interest disclosure statement for the authors was unavailable at press time.

Collection of an oseltamivir-resistant pandemic influenza A(H1N1) isolate in a 59-year-old man taking the drug prophylactically underscores the need to limit antiviral prophylaxis of pandemic flu, according to correspondence published online in the New England Journal of Medicine on Nov. 11.

Oseltamivir was prescribed to all household contacts of the man's 13-year-old son (the index patient), whose infection was confirmed by a reverse-transcriptase polymerase-chain reaction test. The patient's father, mother, and sisters (aged 15 and 18 years) were prescribed 75 mg oseltamivir once daily for 10 days as prophylaxis.

The patient's father was taking 5 mg prednisone daily and had chronic obstructive pulmonary disease. The father developed flulike symptoms approximately 24 hours after prophylaxis began.

On prophylaxis day 8, the father was seen by his physician for a persistent cough, and an H1N1-positive nasopharyngeal aspirate was collected. After an uneventful course of illness, a second sample was negative, the investigators wrote. The case was reported by Mariana Baz, M.Sc., of the Centre Hospitalier Universitaire de Québec, and colleagues (N. Engl. J. Med. 2009 Nov. 11 [Epub doi: 10.1056/NEJMC0910060]).

The sample from the father showed a neuraminidase mutation (H275Y) that has been associated with oseltamivir resistance in seasonal H1N1

"We hypothesize that the presence of subtherapeutic levels of oseltamivir at a time when viral replication had already begun was an important factor that led to the emergence of the resistant virus in the father of our index patient," they wrote.

The case supports the need to limit prophylactic treatment with oseltamivir in persons who have already been exposed to the H1N1 virus, the investigators noted. They also suggested that patients receiving once-daily antiviral prophylaxis convert to a twice-daily regimen as soon as they develop flulike symptoms.

A conflict of interest disclosure statement for the authors was unavailable at press time.

Collection of an oseltamivir-resistant pandemic influenza A(H1N1) isolate in a 59-year-old man taking the drug prophylactically underscores the need to limit antiviral prophylaxis of pandemic flu, according to correspondence published online in the New England Journal of Medicine on Nov. 11.

Oseltamivir was prescribed to all household contacts of the man's 13-year-old son (the index patient), whose infection was confirmed by a reverse-transcriptase polymerase-chain reaction test. The patient's father, mother, and sisters (aged 15 and 18 years) were prescribed 75 mg oseltamivir once daily for 10 days as prophylaxis.

The patient's father was taking 5 mg prednisone daily and had chronic obstructive pulmonary disease. The father developed flulike symptoms approximately 24 hours after prophylaxis began.

On prophylaxis day 8, the father was seen by his physician for a persistent cough, and an H1N1-positive nasopharyngeal aspirate was collected. After an uneventful course of illness, a second sample was negative, the investigators wrote. The case was reported by Mariana Baz, M.Sc., of the Centre Hospitalier Universitaire de Québec, and colleagues (N. Engl. J. Med. 2009 Nov. 11 [Epub doi: 10.1056/NEJMC0910060]).

The sample from the father showed a neuraminidase mutation (H275Y) that has been associated with oseltamivir resistance in seasonal H1N1

"We hypothesize that the presence of subtherapeutic levels of oseltamivir at a time when viral replication had already begun was an important factor that led to the emergence of the resistant virus in the father of our index patient," they wrote.

The case supports the need to limit prophylactic treatment with oseltamivir in persons who have already been exposed to the H1N1 virus, the investigators noted. They also suggested that patients receiving once-daily antiviral prophylaxis convert to a twice-daily regimen as soon as they develop flulike symptoms.

A conflict of interest disclosure statement for the authors was unavailable at press time.

BOSTON — Malnutrition could send obese patients to the emergency department if they have a history of bariatric surgery, Dr. Joshua Broder said at the annual meeting of the American College of Emergency Physicians.

Dr. Broder, of Duke University in Durham, N.C., reviewed the following complications that can arise after different types of bariatric procedures:

▸ Laparoscopic adjustable gastric banding. There have been reports of mechanical problems including breakage, infection, and erosion of the band into the GI tract. Patients often are discharged on the same day or 1 day after undergoing this procedure, he noted.

Early complications include obstruction, edema from intravenous fluids, and proximal migration of the band. Late complications include obstruction and proximal band migration that may cause gastric necrosis and perforation. In cases of gastroesophageal obstruction, deflate the band as soon as possible.

▸ Roux-en-Y gastric bypass. The Roux-en-Y procedure currently is the most common surgery performed to help morbidly obese patients lose weight, Dr. Broder said. It is arguably the most effective because it bypasses a segment of the small bowel and limits the amount of food that can be eaten at a single meal. Early complications from this procedure include anastomosis, found in approximately 2%-11% of these patients.

Long-term complications include systemic nutritional deficiencies because nutrients aren't being absorbed in a section of the small bowel, Dr. Broder said. And the bypassed segment of the small bowel can become obstructed, which produces highly variable symptoms.

▸ Biliopancreatic diversion. The potential for weight loss is high with this type of surgery, but so are the metabolic risks, he noted. All the possible complications of a Roux-en-Y are much more likely, including nutritional deficiencies of fat-soluble vitamins, selenium, and zinc. Studies have shown that about 2% of these patients experience hepatic dysfunction, said Dr. Broder, who disclosed having no financial conflicts.

BOSTON — Malnutrition could send obese patients to the emergency department if they have a history of bariatric surgery, Dr. Joshua Broder said at the annual meeting of the American College of Emergency Physicians.

Dr. Broder, of Duke University in Durham, N.C., reviewed the following complications that can arise after different types of bariatric procedures:

▸ Laparoscopic adjustable gastric banding. There have been reports of mechanical problems including breakage, infection, and erosion of the band into the GI tract. Patients often are discharged on the same day or 1 day after undergoing this procedure, he noted.

Early complications include obstruction, edema from intravenous fluids, and proximal migration of the band. Late complications include obstruction and proximal band migration that may cause gastric necrosis and perforation. In cases of gastroesophageal obstruction, deflate the band as soon as possible.

▸ Roux-en-Y gastric bypass. The Roux-en-Y procedure currently is the most common surgery performed to help morbidly obese patients lose weight, Dr. Broder said. It is arguably the most effective because it bypasses a segment of the small bowel and limits the amount of food that can be eaten at a single meal. Early complications from this procedure include anastomosis, found in approximately 2%-11% of these patients.

Long-term complications include systemic nutritional deficiencies because nutrients aren't being absorbed in a section of the small bowel, Dr. Broder said. And the bypassed segment of the small bowel can become obstructed, which produces highly variable symptoms.

▸ Biliopancreatic diversion. The potential for weight loss is high with this type of surgery, but so are the metabolic risks, he noted. All the possible complications of a Roux-en-Y are much more likely, including nutritional deficiencies of fat-soluble vitamins, selenium, and zinc. Studies have shown that about 2% of these patients experience hepatic dysfunction, said Dr. Broder, who disclosed having no financial conflicts.

BOSTON — Malnutrition could send obese patients to the emergency department if they have a history of bariatric surgery, Dr. Joshua Broder said at the annual meeting of the American College of Emergency Physicians.

Dr. Broder, of Duke University in Durham, N.C., reviewed the following complications that can arise after different types of bariatric procedures:

▸ Laparoscopic adjustable gastric banding. There have been reports of mechanical problems including breakage, infection, and erosion of the band into the GI tract. Patients often are discharged on the same day or 1 day after undergoing this procedure, he noted.

Early complications include obstruction, edema from intravenous fluids, and proximal migration of the band. Late complications include obstruction and proximal band migration that may cause gastric necrosis and perforation. In cases of gastroesophageal obstruction, deflate the band as soon as possible.

▸ Roux-en-Y gastric bypass. The Roux-en-Y procedure currently is the most common surgery performed to help morbidly obese patients lose weight, Dr. Broder said. It is arguably the most effective because it bypasses a segment of the small bowel and limits the amount of food that can be eaten at a single meal. Early complications from this procedure include anastomosis, found in approximately 2%-11% of these patients.

Long-term complications include systemic nutritional deficiencies because nutrients aren't being absorbed in a section of the small bowel, Dr. Broder said. And the bypassed segment of the small bowel can become obstructed, which produces highly variable symptoms.

▸ Biliopancreatic diversion. The potential for weight loss is high with this type of surgery, but so are the metabolic risks, he noted. All the possible complications of a Roux-en-Y are much more likely, including nutritional deficiencies of fat-soluble vitamins, selenium, and zinc. Studies have shown that about 2% of these patients experience hepatic dysfunction, said Dr. Broder, who disclosed having no financial conflicts.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the U.S. Food and Drug Administration. If approved, they will provide additional options for treating obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a double-blind trial of 1,496 adults with an average age of 44 years and an average BMI of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients. Lorcaserin was not associated with increased valvulopathy, said Dr. Kaplan, who has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the U.S. Food and Drug Administration. If approved, they will provide additional options for treating obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a double-blind trial of 1,496 adults with an average age of 44 years and an average BMI of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients. Lorcaserin was not associated with increased valvulopathy, said Dr. Kaplan, who has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the U.S. Food and Drug Administration. If approved, they will provide additional options for treating obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a double-blind trial of 1,496 adults with an average age of 44 years and an average BMI of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients. Lorcaserin was not associated with increased valvulopathy, said Dr. Kaplan, who has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

Women seeking fertility treatments—and all women planning a pregnancy—should be vaccinated against both the seasonal flu and pandemic influenza A(H1N1), according to a joint statement from the Centers for Disease Control and Prevention and the American Society for Reproductive Medicine.

“Fertility clinics should encourage patients planning pregnancy to be vaccinated for both seasonal influenza and 2009 H1N1,” the statement noted. Since certain areas of the United States may have the H1N1 vaccine available only for those in initial target groups—including women who are already pregnant or those who are caring for infants younger than age 6 months—some who are planning a pregnancy may have to wait until more H1N1 vaccine is available. Women planning a pregnancy can receive the seasonal flu shot at any time.

Women who are pregnant should receive the inactivated injectable vaccine for both the H1N1 and seasonal flu vaccines (not the live, activated nasal spray vaccine). Women who are planning a pregnancy and have no medical contraindications for the live, activated vaccine can receive either the injection or the nasal spray for both vaccines before conceiving, according to the statement.

Data have shown that pregnant women infected with the pandemic H1N1 virus have higher rates of hospitalization and death from flu-related complications, compared with the general population.

Visit cdc.gov/h1n1fluflu.gov

Women seeking fertility treatments—and all women planning a pregnancy—should be vaccinated against both the seasonal flu and pandemic influenza A(H1N1), according to a joint statement from the Centers for Disease Control and Prevention and the American Society for Reproductive Medicine.

“Fertility clinics should encourage patients planning pregnancy to be vaccinated for both seasonal influenza and 2009 H1N1,” the statement noted. Since certain areas of the United States may have the H1N1 vaccine available only for those in initial target groups—including women who are already pregnant or those who are caring for infants younger than age 6 months—some who are planning a pregnancy may have to wait until more H1N1 vaccine is available. Women planning a pregnancy can receive the seasonal flu shot at any time.

Women who are pregnant should receive the inactivated injectable vaccine for both the H1N1 and seasonal flu vaccines (not the live, activated nasal spray vaccine). Women who are planning a pregnancy and have no medical contraindications for the live, activated vaccine can receive either the injection or the nasal spray for both vaccines before conceiving, according to the statement.

Data have shown that pregnant women infected with the pandemic H1N1 virus have higher rates of hospitalization and death from flu-related complications, compared with the general population.

Visit cdc.gov/h1n1fluflu.gov

Women seeking fertility treatments—and all women planning a pregnancy—should be vaccinated against both the seasonal flu and pandemic influenza A(H1N1), according to a joint statement from the Centers for Disease Control and Prevention and the American Society for Reproductive Medicine.

“Fertility clinics should encourage patients planning pregnancy to be vaccinated for both seasonal influenza and 2009 H1N1,” the statement noted. Since certain areas of the United States may have the H1N1 vaccine available only for those in initial target groups—including women who are already pregnant or those who are caring for infants younger than age 6 months—some who are planning a pregnancy may have to wait until more H1N1 vaccine is available. Women planning a pregnancy can receive the seasonal flu shot at any time.

Women who are pregnant should receive the inactivated injectable vaccine for both the H1N1 and seasonal flu vaccines (not the live, activated nasal spray vaccine). Women who are planning a pregnancy and have no medical contraindications for the live, activated vaccine can receive either the injection or the nasal spray for both vaccines before conceiving, according to the statement.

Data have shown that pregnant women infected with the pandemic H1N1 virus have higher rates of hospitalization and death from flu-related complications, compared with the general population.

Visit cdc.gov/h1n1fluflu.gov

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years.

ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference.

The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses. The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13-26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that post-marketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS).

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years.

ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference.

The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses. The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13-26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that post-marketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS).

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years.

ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference.

The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses. The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13-26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that post-marketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS).

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

ATLANTA — The meningococcal working group of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices “believes that the ACIP should consider not adding meningococcal conjugate vaccines to the routine infant vaccine schedule at this time,” said working group member Dr. Amanda Cohn.

At its fall meeting, the ACIP discussed safety and epidemiology data on meningococcal vaccines in development for infants. These products have not yet been licensed.

The low burden of meningococcal disease in infants raises the question of whether every vaccine that is shown to be safe and effective should be recommended if the burden of disease is low, said Dr. H. Cody Meissner, chair of the working group.

The last ACIP recommendations for meningococcal vaccines were published in May 2005, and an update is planned for 2010, he noted.

ATLANTA — The meningococcal working group of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices “believes that the ACIP should consider not adding meningococcal conjugate vaccines to the routine infant vaccine schedule at this time,” said working group member Dr. Amanda Cohn.

At its fall meeting, the ACIP discussed safety and epidemiology data on meningococcal vaccines in development for infants. These products have not yet been licensed.

The low burden of meningococcal disease in infants raises the question of whether every vaccine that is shown to be safe and effective should be recommended if the burden of disease is low, said Dr. H. Cody Meissner, chair of the working group.

The last ACIP recommendations for meningococcal vaccines were published in May 2005, and an update is planned for 2010, he noted.

ATLANTA — The meningococcal working group of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices “believes that the ACIP should consider not adding meningococcal conjugate vaccines to the routine infant vaccine schedule at this time,” said working group member Dr. Amanda Cohn.

At its fall meeting, the ACIP discussed safety and epidemiology data on meningococcal vaccines in development for infants. These products have not yet been licensed.

The low burden of meningococcal disease in infants raises the question of whether every vaccine that is shown to be safe and effective should be recommended if the burden of disease is low, said Dr. H. Cody Meissner, chair of the working group.

The last ACIP recommendations for meningococcal vaccines were published in May 2005, and an update is planned for 2010, he noted.

ATLANTA — If it is approved for use in the United States, a 13-valent pneumococcal conjugate vaccine in children would have recommendations mirroring those already in place for the 7-valent vaccine. Draft guidelines on PCV13 were presented at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Committee member Dr. Michael Marcy introduced the discussion of the 13-valent pneumococcal conjugate vaccine (PCV13) and cited recent data from the CDC's Morbidity and Mortality Weekly Report that showed a significant association between bacterial coinfections and severe cases of the pandemic influenza A(H1N1) virus.

The timing of the licensure may allow for the use of PCV13 during the 2009/2010 flu season, noted Dr. Pekka Nuorti of the CDC, who presented the draft recommendations. The Food and Drug Administration's review of the vaccine is ongoing, and a decision is expected this month, said Dr. Peter Paradiso of Wyeth Pharmaceuticals, which makes PCV13.

The vaccine is designed to protect infants and young children against the pneumococcal diseases caused by the seven serotypes in the PCV7 vaccine, plus six additional serotypes: 1, 3, 5, 6A, 7F, and 19A. PCV13 is currently licensed in Chile and Mexico, Dr. Paradiso said.

To expedite a potential transition to PCV13, the CDC said provisions are in place for voting on vaccine recommendations in advance of the next scheduled ACIP meeting in February.

The draft recommendations involve four groups: unvaccinated infants and children, children who have started their PCV vaccine schedules with PCV7, children who have completed the PCV7 schedule, and immunocompromised children or children with chronic illness.

For unvaccinated infants and children, the recommendations are the same as for PCV7, with PCV13 replacing PCV7 for all doses, said Dr. Nuorti.

The draft recommendations also state that children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, and children who have completed the primary infant series with PCV7 should receive a single PCV13 dose during the second year of life to provide protection against the six additional serotypes.

Dr. Nuorti added that the proposed recommendations for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) after PCV13 for individuals aged 2 years and older with underlying medical conditions are the same as those currently recommended for the use of PPSV23 after PCV7, although no safety and immunogenicity data are yet available for this vaccine sequence.

Dr. Paradiso of Wyeth reviewed safety and immunogenicity data presented at an ACIP meeting earlier this year, including comparison data from a study including 125 children aged 15 months to 2 years, and 182 children aged 2 years to 5 years. The studies suggest that the safety profiles and immune responses were similar to those seen with PCV7.

Children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, said Dr. Pekka Nuorti of the CDC.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — If it is approved for use in the United States, a 13-valent pneumococcal conjugate vaccine in children would have recommendations mirroring those already in place for the 7-valent vaccine. Draft guidelines on PCV13 were presented at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Committee member Dr. Michael Marcy introduced the discussion of the 13-valent pneumococcal conjugate vaccine (PCV13) and cited recent data from the CDC's Morbidity and Mortality Weekly Report that showed a significant association between bacterial coinfections and severe cases of the pandemic influenza A(H1N1) virus.

The timing of the licensure may allow for the use of PCV13 during the 2009/2010 flu season, noted Dr. Pekka Nuorti of the CDC, who presented the draft recommendations. The Food and Drug Administration's review of the vaccine is ongoing, and a decision is expected this month, said Dr. Peter Paradiso of Wyeth Pharmaceuticals, which makes PCV13.

The vaccine is designed to protect infants and young children against the pneumococcal diseases caused by the seven serotypes in the PCV7 vaccine, plus six additional serotypes: 1, 3, 5, 6A, 7F, and 19A. PCV13 is currently licensed in Chile and Mexico, Dr. Paradiso said.

To expedite a potential transition to PCV13, the CDC said provisions are in place for voting on vaccine recommendations in advance of the next scheduled ACIP meeting in February.

The draft recommendations involve four groups: unvaccinated infants and children, children who have started their PCV vaccine schedules with PCV7, children who have completed the PCV7 schedule, and immunocompromised children or children with chronic illness.

For unvaccinated infants and children, the recommendations are the same as for PCV7, with PCV13 replacing PCV7 for all doses, said Dr. Nuorti.

The draft recommendations also state that children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, and children who have completed the primary infant series with PCV7 should receive a single PCV13 dose during the second year of life to provide protection against the six additional serotypes.

Dr. Nuorti added that the proposed recommendations for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) after PCV13 for individuals aged 2 years and older with underlying medical conditions are the same as those currently recommended for the use of PPSV23 after PCV7, although no safety and immunogenicity data are yet available for this vaccine sequence.

Dr. Paradiso of Wyeth reviewed safety and immunogenicity data presented at an ACIP meeting earlier this year, including comparison data from a study including 125 children aged 15 months to 2 years, and 182 children aged 2 years to 5 years. The studies suggest that the safety profiles and immune responses were similar to those seen with PCV7.

Children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, said Dr. Pekka Nuorti of the CDC.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — If it is approved for use in the United States, a 13-valent pneumococcal conjugate vaccine in children would have recommendations mirroring those already in place for the 7-valent vaccine. Draft guidelines on PCV13 were presented at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Committee member Dr. Michael Marcy introduced the discussion of the 13-valent pneumococcal conjugate vaccine (PCV13) and cited recent data from the CDC's Morbidity and Mortality Weekly Report that showed a significant association between bacterial coinfections and severe cases of the pandemic influenza A(H1N1) virus.

The timing of the licensure may allow for the use of PCV13 during the 2009/2010 flu season, noted Dr. Pekka Nuorti of the CDC, who presented the draft recommendations. The Food and Drug Administration's review of the vaccine is ongoing, and a decision is expected this month, said Dr. Peter Paradiso of Wyeth Pharmaceuticals, which makes PCV13.

The vaccine is designed to protect infants and young children against the pneumococcal diseases caused by the seven serotypes in the PCV7 vaccine, plus six additional serotypes: 1, 3, 5, 6A, 7F, and 19A. PCV13 is currently licensed in Chile and Mexico, Dr. Paradiso said.

To expedite a potential transition to PCV13, the CDC said provisions are in place for voting on vaccine recommendations in advance of the next scheduled ACIP meeting in February.

The draft recommendations involve four groups: unvaccinated infants and children, children who have started their PCV vaccine schedules with PCV7, children who have completed the PCV7 schedule, and immunocompromised children or children with chronic illness.

For unvaccinated infants and children, the recommendations are the same as for PCV7, with PCV13 replacing PCV7 for all doses, said Dr. Nuorti.

The draft recommendations also state that children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, and children who have completed the primary infant series with PCV7 should receive a single PCV13 dose during the second year of life to provide protection against the six additional serotypes.

Dr. Nuorti added that the proposed recommendations for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) after PCV13 for individuals aged 2 years and older with underlying medical conditions are the same as those currently recommended for the use of PPSV23 after PCV7, although no safety and immunogenicity data are yet available for this vaccine sequence.

Dr. Paradiso of Wyeth reviewed safety and immunogenicity data presented at an ACIP meeting earlier this year, including comparison data from a study including 125 children aged 15 months to 2 years, and 182 children aged 2 years to 5 years. The studies suggest that the safety profiles and immune responses were similar to those seen with PCV7.

Children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, said Dr. Pekka Nuorti of the CDC.

Source Parker Smith/Elsevier Global Medical News

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The patients in the treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, which was the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian serves on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University, Boston, presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The patients in the treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, which was the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian serves on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University, Boston, presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The patients in the treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, which was the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian serves on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University, Boston, presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.