Sherry Boschert

WASHINGTON — New recommendations to test routinely for HIV in all patients aged 13–64 years will overburden the U.S. health care system with newly diagnosed patients unless additional funding is provided, experts said at a press briefing by the Centers for Disease Control and Prevention.

The CDC now recommends "opt-out" testing in which HIV screening is incorporated into routine health care unless the patient declines to be tested. That could identify 56,000 of the 250,000 U.S. residents who are unaware of their infection, generating a need for greater than $900 million in additional funding for counseling and treatment services, said Dr. Kevin Fenton, director of the CDC's National Center for HIV, Sexually Transmitted Diseases, and Tuberculosis Prevention.

He and others spoke at a briefing during a 2-day summit sponsored by the CDC on ways to expand HIV testing and the potential impact of increased numbers of patients diagnosed with HIV.

Approximately 25% of 1.2 million people thought to be living with HIV in the United States are unaware of their infections, the CDC estimates. Dr. Michael Saag, director of the Center for AIDS Research at the University of Alabama, Birmingham, said he believes that 25% may be a low estimate. Three-quarters of patients diagnosed with HIV at his clinics have very low CD4 counts, indicating that they probably have been infected for 10–12 years.

Treating the infection early greatly improves survival at 8 years and reduces transmission of the virus. "That screams at us that we should be testing earlier, but with that comes an obligation to provide access to care. At our clinic, we're already at capacity," Dr. Saag said.

His institution collects around $360/patient per year in Ryan White Act funding for HIV care, which provides only about $360,000/year of the $2.1 million needed to care for the 1,400 patients served. "It's not sufficient," he said.

Legislation to renew the Ryan White Act has been stalled in Congress for months, he added.

Clinicians who provide HIV care are among the lowest paid health care providers, Dr. Saag's analyses suggest. People entering health care professions see the overworked clinicians and underfunded caring for patients with HIV and AIDS, and fewer today are interested in working in HIV care, he said.

At the Johns Hopkins University clinics in Baltimore, most patients with HIV are unemployed, and 45% are uninsured—demographics that are common to other areas of the country, Dr. John S. Bartlett added. Caring for thousands of newly diagnosed HIV infections "will take clinics committed to taking care of the underserved," said Dr. Bartlett, professor of medicine and chief of infectious diseases at the university.

The burden of new diagnoses should not be a barrier to wider HIV testing, the panel emphasized.

To improve screening rates, more than funding will be needed, added Phill Wilson, founder and executive director of the Black AIDS Institute in Los Angeles. People who are unaware of their HIV infection are more likely to be young minorities, particularly African Americans. The stigma of HIV infection must be addressed by mobilizing the black community, he said.

"In an environment where testing is free, painless, quick, and can save someone's life, why are people reluctant to get tested? The debilitating stigma" of AIDS, Mr. Wilson said.

National investment in HIV-prevention programs correlates with the level of new infections over time, according to an analysis by David R. Holtgrave, Ph.D., chair of the school of public health at Johns Hopkins University. The CDC's current budget of $700 million/year for HIV prevention is about $350 million short of what's needed for comprehensive prevention services, he estimated.

WASHINGTON — New recommendations to test routinely for HIV in all patients aged 13–64 years will overburden the U.S. health care system with newly diagnosed patients unless additional funding is provided, experts said at a press briefing by the Centers for Disease Control and Prevention.

The CDC now recommends "opt-out" testing in which HIV screening is incorporated into routine health care unless the patient declines to be tested. That could identify 56,000 of the 250,000 U.S. residents who are unaware of their infection, generating a need for greater than $900 million in additional funding for counseling and treatment services, said Dr. Kevin Fenton, director of the CDC's National Center for HIV, Sexually Transmitted Diseases, and Tuberculosis Prevention.

He and others spoke at a briefing during a 2-day summit sponsored by the CDC on ways to expand HIV testing and the potential impact of increased numbers of patients diagnosed with HIV.

Approximately 25% of 1.2 million people thought to be living with HIV in the United States are unaware of their infections, the CDC estimates. Dr. Michael Saag, director of the Center for AIDS Research at the University of Alabama, Birmingham, said he believes that 25% may be a low estimate. Three-quarters of patients diagnosed with HIV at his clinics have very low CD4 counts, indicating that they probably have been infected for 10–12 years.

Treating the infection early greatly improves survival at 8 years and reduces transmission of the virus. "That screams at us that we should be testing earlier, but with that comes an obligation to provide access to care. At our clinic, we're already at capacity," Dr. Saag said.

His institution collects around $360/patient per year in Ryan White Act funding for HIV care, which provides only about $360,000/year of the $2.1 million needed to care for the 1,400 patients served. "It's not sufficient," he said.

Legislation to renew the Ryan White Act has been stalled in Congress for months, he added.

Clinicians who provide HIV care are among the lowest paid health care providers, Dr. Saag's analyses suggest. People entering health care professions see the overworked clinicians and underfunded caring for patients with HIV and AIDS, and fewer today are interested in working in HIV care, he said.

At the Johns Hopkins University clinics in Baltimore, most patients with HIV are unemployed, and 45% are uninsured—demographics that are common to other areas of the country, Dr. John S. Bartlett added. Caring for thousands of newly diagnosed HIV infections "will take clinics committed to taking care of the underserved," said Dr. Bartlett, professor of medicine and chief of infectious diseases at the university.

The burden of new diagnoses should not be a barrier to wider HIV testing, the panel emphasized.

To improve screening rates, more than funding will be needed, added Phill Wilson, founder and executive director of the Black AIDS Institute in Los Angeles. People who are unaware of their HIV infection are more likely to be young minorities, particularly African Americans. The stigma of HIV infection must be addressed by mobilizing the black community, he said.

"In an environment where testing is free, painless, quick, and can save someone's life, why are people reluctant to get tested? The debilitating stigma" of AIDS, Mr. Wilson said.

National investment in HIV-prevention programs correlates with the level of new infections over time, according to an analysis by David R. Holtgrave, Ph.D., chair of the school of public health at Johns Hopkins University. The CDC's current budget of $700 million/year for HIV prevention is about $350 million short of what's needed for comprehensive prevention services, he estimated.

WASHINGTON — New recommendations to test routinely for HIV in all patients aged 13–64 years will overburden the U.S. health care system with newly diagnosed patients unless additional funding is provided, experts said at a press briefing by the Centers for Disease Control and Prevention.

The CDC now recommends "opt-out" testing in which HIV screening is incorporated into routine health care unless the patient declines to be tested. That could identify 56,000 of the 250,000 U.S. residents who are unaware of their infection, generating a need for greater than $900 million in additional funding for counseling and treatment services, said Dr. Kevin Fenton, director of the CDC's National Center for HIV, Sexually Transmitted Diseases, and Tuberculosis Prevention.

He and others spoke at a briefing during a 2-day summit sponsored by the CDC on ways to expand HIV testing and the potential impact of increased numbers of patients diagnosed with HIV.

Approximately 25% of 1.2 million people thought to be living with HIV in the United States are unaware of their infections, the CDC estimates. Dr. Michael Saag, director of the Center for AIDS Research at the University of Alabama, Birmingham, said he believes that 25% may be a low estimate. Three-quarters of patients diagnosed with HIV at his clinics have very low CD4 counts, indicating that they probably have been infected for 10–12 years.

Treating the infection early greatly improves survival at 8 years and reduces transmission of the virus. "That screams at us that we should be testing earlier, but with that comes an obligation to provide access to care. At our clinic, we're already at capacity," Dr. Saag said.

His institution collects around $360/patient per year in Ryan White Act funding for HIV care, which provides only about $360,000/year of the $2.1 million needed to care for the 1,400 patients served. "It's not sufficient," he said.

Legislation to renew the Ryan White Act has been stalled in Congress for months, he added.

Clinicians who provide HIV care are among the lowest paid health care providers, Dr. Saag's analyses suggest. People entering health care professions see the overworked clinicians and underfunded caring for patients with HIV and AIDS, and fewer today are interested in working in HIV care, he said.

At the Johns Hopkins University clinics in Baltimore, most patients with HIV are unemployed, and 45% are uninsured—demographics that are common to other areas of the country, Dr. John S. Bartlett added. Caring for thousands of newly diagnosed HIV infections "will take clinics committed to taking care of the underserved," said Dr. Bartlett, professor of medicine and chief of infectious diseases at the university.

The burden of new diagnoses should not be a barrier to wider HIV testing, the panel emphasized.

To improve screening rates, more than funding will be needed, added Phill Wilson, founder and executive director of the Black AIDS Institute in Los Angeles. People who are unaware of their HIV infection are more likely to be young minorities, particularly African Americans. The stigma of HIV infection must be addressed by mobilizing the black community, he said.

"In an environment where testing is free, painless, quick, and can save someone's life, why are people reluctant to get tested? The debilitating stigma" of AIDS, Mr. Wilson said.

National investment in HIV-prevention programs correlates with the level of new infections over time, according to an analysis by David R. Holtgrave, Ph.D., chair of the school of public health at Johns Hopkins University. The CDC's current budget of $700 million/year for HIV prevention is about $350 million short of what's needed for comprehensive prevention services, he estimated.

SAN DIEGO — Thinking of weight gain simply as the sum of “calories in minus calories out” doesn't cover a minority of obese patients whose dietary records show reasonable caloric balance but who can't seem to lose weight, Dr. Scott R. Rigden said.

These patients may show dietary records reflecting an intake of 1,800–1,900 calories per day, and often say they're tired of health care providers thinking that they're lying in their food diaries because they haven't lost weight, he said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.

“I really think there are a lot of people with special issues, with switched-off metabolisms, that don't fit that model” of calories in/calories out, said Dr. Rigden, a Chandler, Ariz. family physician who has practiced bariatrics since 1976. “What has shut down their metabolism, and how do we turn it back on?”

To help these patients, think in terms of the following five subcategories, and tailor dietary and lifestyle recommendations accordingly, he suggested:

▸ Carbohydrate sensitivity. Dr. Rigden defined a patient with carbohydrate sensitivity as one whose genetic makeup produces a rapid spike of glucose after consuming simple carbohydrates and sugars. That glucose spike in turn triggers a spike in insulin and associated metabolic cellular messengers that tell the body to store fat, not burn it. The insulin spike also causes a rapid and uncomfortable drop in glucose that motivates the person to seek more carbohydrates and sugars to remedy the discomfort.

These patients do not yet meet criteria for metabolic syndrome. They have normal fasting insulin and glucose levels and are not hypertensive. “They often have stellar labs, yet a terrible lifelong obesity issue,” Dr. Rigden said. He has devised a nine-item questionnaire focusing on eating and exercise habits to identify this subgroup.

A four-step treatment plan starts with behavior modification to change the patient's relationship with food and an exercise program with at least 150 minutes of moderate aerobic exercise weekly. The third step emphasizes adequate water intake of at least 64 ounces per day—“perhaps the most overlooked part of a weight management program,” he added.

Dietary intervention is the fourth step, starting with a soy protein powder meal replacement plan and switching to a low glycemic diet (which he also called a modified Mediterranean diet) after the patient loses 5%–10% of initial weight.

▸ Metabolic syndrome. Diagnostic criteria for metabolic syndrome include an elevated waist circumference, triglyceride level above 150 mg/dL, an HDL level less than 40 mg/dL for males or less than 50 mg/dL for females, blood pressure above 130/85 mm Hg, and fasting blood sugar above 100 mg/dL.

In these patients, foods that have a high glycemic index cause blood sugar levels to plummet, boosting cravings for more high-glycemic foods such as sugars and fat, Dr. Rigden said. He recommends what he calls a “caveman or cavewoman” diet of low-fat, nonstarchy foods that he spells out for patients. After losing 10% of body weight, they switch to the low glycemic diet.

He also recommends nutraceutical medical food with slow-release, amylose-resistant starch, and soluble fiber in the form of 15 g per day of guar gum. Micronutrient support may be the most undervalued component of therapy for these patients, he added.

▸ Hormonal imbalances. Questionnaires and physical examinations will help identify the endocrine problems that are contributing to recalcitrant obesity in these patients, Dr. Rigden said. Most will be due to clinical or subclinical hypothyroidism. “This is probably the No. 1 hormonal imbalance that I see in people who have switched-off metabolism,” he said.

Other hormonal problems to consider in women include polycystic ovarian syndrome or a sex hormone imbalance with estrogen dominance. Tailor treatment to the particular problem, he said.

▸ Food hypersensitivity. These are not true allergies but hypersensitivities that can lead to switched-off metabolism, Dr. Rigden said. Wheat and milk are the most common reactors, with delayed physical findings—such as boggy nasal mucosa, mouth breathing, wheezing, eczema, or urticaria—appearing 24–72 hours after ingestion. IgG levels may help identify offending foods.

Eliminate the problem foods from the patient's diet for 90–120 days, then perform a careful challenge with the food, and urge minimal intake of problem foods thereafter, he suggested.

▸ Chronic illness. Some patients complain that they never had weight problems until diagnosed with chronic fatigue syndrome, fibromyalgia, lupus, rheumatoid arthritis, irritable bowel syndrome, or other chronic problems.

In these patients, the liver's detoxification abilities are impaired, leaving higher levels of toxins in the body that compromise fat metabolism, he said. Eliminate common dietary allergens such as gluten for 4 weeks and support liver detoxification with a hypoallergenic rice-based protein formula containing selected nutrients, Dr. Rigden recommended.

He disclosed that he has no association with the companies that make the products he discussed.

SAN DIEGO — Thinking of weight gain simply as the sum of “calories in minus calories out” doesn't cover a minority of obese patients whose dietary records show reasonable caloric balance but who can't seem to lose weight, Dr. Scott R. Rigden said.

These patients may show dietary records reflecting an intake of 1,800–1,900 calories per day, and often say they're tired of health care providers thinking that they're lying in their food diaries because they haven't lost weight, he said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.

“I really think there are a lot of people with special issues, with switched-off metabolisms, that don't fit that model” of calories in/calories out, said Dr. Rigden, a Chandler, Ariz. family physician who has practiced bariatrics since 1976. “What has shut down their metabolism, and how do we turn it back on?”

To help these patients, think in terms of the following five subcategories, and tailor dietary and lifestyle recommendations accordingly, he suggested:

▸ Carbohydrate sensitivity. Dr. Rigden defined a patient with carbohydrate sensitivity as one whose genetic makeup produces a rapid spike of glucose after consuming simple carbohydrates and sugars. That glucose spike in turn triggers a spike in insulin and associated metabolic cellular messengers that tell the body to store fat, not burn it. The insulin spike also causes a rapid and uncomfortable drop in glucose that motivates the person to seek more carbohydrates and sugars to remedy the discomfort.

These patients do not yet meet criteria for metabolic syndrome. They have normal fasting insulin and glucose levels and are not hypertensive. “They often have stellar labs, yet a terrible lifelong obesity issue,” Dr. Rigden said. He has devised a nine-item questionnaire focusing on eating and exercise habits to identify this subgroup.

A four-step treatment plan starts with behavior modification to change the patient's relationship with food and an exercise program with at least 150 minutes of moderate aerobic exercise weekly. The third step emphasizes adequate water intake of at least 64 ounces per day—“perhaps the most overlooked part of a weight management program,” he added.

Dietary intervention is the fourth step, starting with a soy protein powder meal replacement plan and switching to a low glycemic diet (which he also called a modified Mediterranean diet) after the patient loses 5%–10% of initial weight.

▸ Metabolic syndrome. Diagnostic criteria for metabolic syndrome include an elevated waist circumference, triglyceride level above 150 mg/dL, an HDL level less than 40 mg/dL for males or less than 50 mg/dL for females, blood pressure above 130/85 mm Hg, and fasting blood sugar above 100 mg/dL.

In these patients, foods that have a high glycemic index cause blood sugar levels to plummet, boosting cravings for more high-glycemic foods such as sugars and fat, Dr. Rigden said. He recommends what he calls a “caveman or cavewoman” diet of low-fat, nonstarchy foods that he spells out for patients. After losing 10% of body weight, they switch to the low glycemic diet.

He also recommends nutraceutical medical food with slow-release, amylose-resistant starch, and soluble fiber in the form of 15 g per day of guar gum. Micronutrient support may be the most undervalued component of therapy for these patients, he added.

▸ Hormonal imbalances. Questionnaires and physical examinations will help identify the endocrine problems that are contributing to recalcitrant obesity in these patients, Dr. Rigden said. Most will be due to clinical or subclinical hypothyroidism. “This is probably the No. 1 hormonal imbalance that I see in people who have switched-off metabolism,” he said.

Other hormonal problems to consider in women include polycystic ovarian syndrome or a sex hormone imbalance with estrogen dominance. Tailor treatment to the particular problem, he said.

▸ Food hypersensitivity. These are not true allergies but hypersensitivities that can lead to switched-off metabolism, Dr. Rigden said. Wheat and milk are the most common reactors, with delayed physical findings—such as boggy nasal mucosa, mouth breathing, wheezing, eczema, or urticaria—appearing 24–72 hours after ingestion. IgG levels may help identify offending foods.

Eliminate the problem foods from the patient's diet for 90–120 days, then perform a careful challenge with the food, and urge minimal intake of problem foods thereafter, he suggested.

▸ Chronic illness. Some patients complain that they never had weight problems until diagnosed with chronic fatigue syndrome, fibromyalgia, lupus, rheumatoid arthritis, irritable bowel syndrome, or other chronic problems.

In these patients, the liver's detoxification abilities are impaired, leaving higher levels of toxins in the body that compromise fat metabolism, he said. Eliminate common dietary allergens such as gluten for 4 weeks and support liver detoxification with a hypoallergenic rice-based protein formula containing selected nutrients, Dr. Rigden recommended.

He disclosed that he has no association with the companies that make the products he discussed.

SAN DIEGO — Thinking of weight gain simply as the sum of “calories in minus calories out” doesn't cover a minority of obese patients whose dietary records show reasonable caloric balance but who can't seem to lose weight, Dr. Scott R. Rigden said.

These patients may show dietary records reflecting an intake of 1,800–1,900 calories per day, and often say they're tired of health care providers thinking that they're lying in their food diaries because they haven't lost weight, he said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.

“I really think there are a lot of people with special issues, with switched-off metabolisms, that don't fit that model” of calories in/calories out, said Dr. Rigden, a Chandler, Ariz. family physician who has practiced bariatrics since 1976. “What has shut down their metabolism, and how do we turn it back on?”

To help these patients, think in terms of the following five subcategories, and tailor dietary and lifestyle recommendations accordingly, he suggested:

▸ Carbohydrate sensitivity. Dr. Rigden defined a patient with carbohydrate sensitivity as one whose genetic makeup produces a rapid spike of glucose after consuming simple carbohydrates and sugars. That glucose spike in turn triggers a spike in insulin and associated metabolic cellular messengers that tell the body to store fat, not burn it. The insulin spike also causes a rapid and uncomfortable drop in glucose that motivates the person to seek more carbohydrates and sugars to remedy the discomfort.

These patients do not yet meet criteria for metabolic syndrome. They have normal fasting insulin and glucose levels and are not hypertensive. “They often have stellar labs, yet a terrible lifelong obesity issue,” Dr. Rigden said. He has devised a nine-item questionnaire focusing on eating and exercise habits to identify this subgroup.

A four-step treatment plan starts with behavior modification to change the patient's relationship with food and an exercise program with at least 150 minutes of moderate aerobic exercise weekly. The third step emphasizes adequate water intake of at least 64 ounces per day—“perhaps the most overlooked part of a weight management program,” he added.

Dietary intervention is the fourth step, starting with a soy protein powder meal replacement plan and switching to a low glycemic diet (which he also called a modified Mediterranean diet) after the patient loses 5%–10% of initial weight.

▸ Metabolic syndrome. Diagnostic criteria for metabolic syndrome include an elevated waist circumference, triglyceride level above 150 mg/dL, an HDL level less than 40 mg/dL for males or less than 50 mg/dL for females, blood pressure above 130/85 mm Hg, and fasting blood sugar above 100 mg/dL.

In these patients, foods that have a high glycemic index cause blood sugar levels to plummet, boosting cravings for more high-glycemic foods such as sugars and fat, Dr. Rigden said. He recommends what he calls a “caveman or cavewoman” diet of low-fat, nonstarchy foods that he spells out for patients. After losing 10% of body weight, they switch to the low glycemic diet.

He also recommends nutraceutical medical food with slow-release, amylose-resistant starch, and soluble fiber in the form of 15 g per day of guar gum. Micronutrient support may be the most undervalued component of therapy for these patients, he added.

▸ Hormonal imbalances. Questionnaires and physical examinations will help identify the endocrine problems that are contributing to recalcitrant obesity in these patients, Dr. Rigden said. Most will be due to clinical or subclinical hypothyroidism. “This is probably the No. 1 hormonal imbalance that I see in people who have switched-off metabolism,” he said.

Other hormonal problems to consider in women include polycystic ovarian syndrome or a sex hormone imbalance with estrogen dominance. Tailor treatment to the particular problem, he said.

▸ Food hypersensitivity. These are not true allergies but hypersensitivities that can lead to switched-off metabolism, Dr. Rigden said. Wheat and milk are the most common reactors, with delayed physical findings—such as boggy nasal mucosa, mouth breathing, wheezing, eczema, or urticaria—appearing 24–72 hours after ingestion. IgG levels may help identify offending foods.

Eliminate the problem foods from the patient's diet for 90–120 days, then perform a careful challenge with the food, and urge minimal intake of problem foods thereafter, he suggested.

▸ Chronic illness. Some patients complain that they never had weight problems until diagnosed with chronic fatigue syndrome, fibromyalgia, lupus, rheumatoid arthritis, irritable bowel syndrome, or other chronic problems.

In these patients, the liver's detoxification abilities are impaired, leaving higher levels of toxins in the body that compromise fat metabolism, he said. Eliminate common dietary allergens such as gluten for 4 weeks and support liver detoxification with a hypoallergenic rice-based protein formula containing selected nutrients, Dr. Rigden recommended.

He disclosed that he has no association with the companies that make the products he discussed.

SAN FRANCISCO — Don't drop your suspicions about serious bacterial infection in infants up to 60 days old just because they're infected with respiratory syncytial virus (RSV), Dr. Laura M. Cerny said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Recent reports implying that infants with RSV infection are less likely to have concurrent bacterial infection than are those without RSV may have moved some providers to stop screening for serious bacterial infection in these patients. So Dr. Cerny and her associates retrospectively reviewed charts on 261 infants discharged from one hospital with a diagnosis of RSV from October 2003 to May 2005.

Serious bacterial infections were documented in 8% of the infants, the researchers reported in a poster presentation at the meeting, which was sponsored by the American Society for Microbiology.

Even if they have RSV, infants aged 60 days old or younger are still at risk for serious bacterial infection. “Don't let your guard down,” said Dr. Cerny, a pediatric fellow at Children's Hospital of Orange County, Calif., and Harbor-University of California, Los Angeles, Medical Center.

Be concerned about RSV-positive infants aged 60 days old or younger who look ill or have a fever higher than 39° C, because these factors may increase the risk for serious bacterial infection. The investigators retrospectively applied the Rochester criteria to screen for serious bacterial infection and found the criteria valuable for discerning patients with higher risk. The criteria use historical, clinical, and laboratory data to predict risk.

SAN FRANCISCO — Don't drop your suspicions about serious bacterial infection in infants up to 60 days old just because they're infected with respiratory syncytial virus (RSV), Dr. Laura M. Cerny said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Recent reports implying that infants with RSV infection are less likely to have concurrent bacterial infection than are those without RSV may have moved some providers to stop screening for serious bacterial infection in these patients. So Dr. Cerny and her associates retrospectively reviewed charts on 261 infants discharged from one hospital with a diagnosis of RSV from October 2003 to May 2005.

Serious bacterial infections were documented in 8% of the infants, the researchers reported in a poster presentation at the meeting, which was sponsored by the American Society for Microbiology.

Even if they have RSV, infants aged 60 days old or younger are still at risk for serious bacterial infection. “Don't let your guard down,” said Dr. Cerny, a pediatric fellow at Children's Hospital of Orange County, Calif., and Harbor-University of California, Los Angeles, Medical Center.

Be concerned about RSV-positive infants aged 60 days old or younger who look ill or have a fever higher than 39° C, because these factors may increase the risk for serious bacterial infection. The investigators retrospectively applied the Rochester criteria to screen for serious bacterial infection and found the criteria valuable for discerning patients with higher risk. The criteria use historical, clinical, and laboratory data to predict risk.

SAN FRANCISCO — Don't drop your suspicions about serious bacterial infection in infants up to 60 days old just because they're infected with respiratory syncytial virus (RSV), Dr. Laura M. Cerny said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Recent reports implying that infants with RSV infection are less likely to have concurrent bacterial infection than are those without RSV may have moved some providers to stop screening for serious bacterial infection in these patients. So Dr. Cerny and her associates retrospectively reviewed charts on 261 infants discharged from one hospital with a diagnosis of RSV from October 2003 to May 2005.

Serious bacterial infections were documented in 8% of the infants, the researchers reported in a poster presentation at the meeting, which was sponsored by the American Society for Microbiology.

Even if they have RSV, infants aged 60 days old or younger are still at risk for serious bacterial infection. “Don't let your guard down,” said Dr. Cerny, a pediatric fellow at Children's Hospital of Orange County, Calif., and Harbor-University of California, Los Angeles, Medical Center.

Be concerned about RSV-positive infants aged 60 days old or younger who look ill or have a fever higher than 39° C, because these factors may increase the risk for serious bacterial infection. The investigators retrospectively applied the Rochester criteria to screen for serious bacterial infection and found the criteria valuable for discerning patients with higher risk. The criteria use historical, clinical, and laboratory data to predict risk.

SAN FRANCISCO — Two new and simple tools may help predict which patients with community-acquired pneumonia are likely to die or to need ICU care, investigators reported in separate presentations at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The tools could help clinicians flag some patients for more intensive treatment and monitoring, whereas others could be managed as outpatients. Adults with community-acquired pneumonia (CAP) and any of four clinical predictors had an increased risk of death within 30 days in a study of 1,525 patients, said Maylee Chen, Pharm.D., at the meeting, which was sponsored by the American Society for Microbiology.

The odds for 30-day mortality nearly tripled in patients with cerebrovascular disease or hypoxemia (defined as partial pressure of arterial oxygen less than 60 mm Hg, ratio of partial pressure of arterial oxygen to fractional inspiratory oxygen less than 300, or oxygen saturation less than 90% by oximetry). The odds for 30-day mortality doubled in patients with coexisting neoplasm or uremia (defined as a BUN of at least 30 mg/dL), said Dr. Chen, who led the study while a fellow at the University of Louisville (Ky.), and now practices at the Queen's Medical Center, Honolulu.

The 30-day mortality rate in the cohort overall was 16%. Without any of the four predictors, 6% of patients with CAP died within 30 days. Death rates within 30 days ranged from 23% to 55% for patients with one of the four clinical predictors.

Cerebrovascular disease, hypoxemia, neoplasm, and uremia are among 20 criteria used in the Pneumonia Severity Index to predict risk. The study validates use of the simplified model for predicting risk of death from community-acquired pneumonia, Dr. Chen said. Patients with the highest risk by the Pneumonia Severity Index (rated class V) were the most likely to die and the most likely to have one or more of the four clinical predictors of death.

Patient data came from the multinational Community-Acquired Pneumonia Organization study. Dr. Chen and her associates also performed a secondary analysis that included 982 patients whose 30-day mortality was unknown—assuming that any patient with an unknown outcome survived—in addition to the 1,525 patients with known outcomes. Each of the four clinical variables remained a significant predictor of 30-day mortality, she said.

In a separate presentation, Dr. Patrick G. P. Charles of Austin Hospital, Heidelberg, Victoria, Australia, described another assessment tool that may predict the need for ICU care of patients with CAP if a planned prospective study validates preliminary findings.

The SMARTCOP assessment tool gauges risk for ICU care by assigning points to patients based on these characteristics:

▸ Systolic blood pressure below 90 mm Hg.

▸ Multilobar chest x-ray involvement.

▸ Albumin less than 3.5 g/dL.

▸ Respiratory rate (at least 30 breaths per minute in patients aged 40 years or older, at least 25 breaths per minute if younger).

▸ Tachycardia of 125 beats per minute, or higher.

▸ Confusion.

▸ Poor oxygenation.

▸ pH below 7.35.

Early data from a study of 849 patients showed the SMARTCOP tool (and an abbreviated version, SMRT-CP) were simpler and as accurate as two tools already used in predicting the need for ICU care, said Dr. Charles and associates, who compared SMARTCOP and SMRT-CP with the Pneumonia Severity Index and CURB-65. The latter assesses community-acquired pneumonia risk based on the presence of confusion, urea nitrogen levels, respiratory rate, blood pressure, and age of 65 years or older. Overall, 10% of the patients needed ICU care, and 5% died within 30 days. The study excluded patients who were likely to die within 12–24 hours and were admitted for palliative care, so mortality was lower than might be expected.

SMARTCOP was simpler and as accurate as two tools already used in predicting the need for ICU care. DR. CHARLES

SAN FRANCISCO — Two new and simple tools may help predict which patients with community-acquired pneumonia are likely to die or to need ICU care, investigators reported in separate presentations at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The tools could help clinicians flag some patients for more intensive treatment and monitoring, whereas others could be managed as outpatients. Adults with community-acquired pneumonia (CAP) and any of four clinical predictors had an increased risk of death within 30 days in a study of 1,525 patients, said Maylee Chen, Pharm.D., at the meeting, which was sponsored by the American Society for Microbiology.

The odds for 30-day mortality nearly tripled in patients with cerebrovascular disease or hypoxemia (defined as partial pressure of arterial oxygen less than 60 mm Hg, ratio of partial pressure of arterial oxygen to fractional inspiratory oxygen less than 300, or oxygen saturation less than 90% by oximetry). The odds for 30-day mortality doubled in patients with coexisting neoplasm or uremia (defined as a BUN of at least 30 mg/dL), said Dr. Chen, who led the study while a fellow at the University of Louisville (Ky.), and now practices at the Queen's Medical Center, Honolulu.

The 30-day mortality rate in the cohort overall was 16%. Without any of the four predictors, 6% of patients with CAP died within 30 days. Death rates within 30 days ranged from 23% to 55% for patients with one of the four clinical predictors.

Cerebrovascular disease, hypoxemia, neoplasm, and uremia are among 20 criteria used in the Pneumonia Severity Index to predict risk. The study validates use of the simplified model for predicting risk of death from community-acquired pneumonia, Dr. Chen said. Patients with the highest risk by the Pneumonia Severity Index (rated class V) were the most likely to die and the most likely to have one or more of the four clinical predictors of death.

Patient data came from the multinational Community-Acquired Pneumonia Organization study. Dr. Chen and her associates also performed a secondary analysis that included 982 patients whose 30-day mortality was unknown—assuming that any patient with an unknown outcome survived—in addition to the 1,525 patients with known outcomes. Each of the four clinical variables remained a significant predictor of 30-day mortality, she said.

In a separate presentation, Dr. Patrick G. P. Charles of Austin Hospital, Heidelberg, Victoria, Australia, described another assessment tool that may predict the need for ICU care of patients with CAP if a planned prospective study validates preliminary findings.

The SMARTCOP assessment tool gauges risk for ICU care by assigning points to patients based on these characteristics:

▸ Systolic blood pressure below 90 mm Hg.

▸ Multilobar chest x-ray involvement.

▸ Albumin less than 3.5 g/dL.

▸ Respiratory rate (at least 30 breaths per minute in patients aged 40 years or older, at least 25 breaths per minute if younger).

▸ Tachycardia of 125 beats per minute, or higher.

▸ Confusion.

▸ Poor oxygenation.

▸ pH below 7.35.

Early data from a study of 849 patients showed the SMARTCOP tool (and an abbreviated version, SMRT-CP) were simpler and as accurate as two tools already used in predicting the need for ICU care, said Dr. Charles and associates, who compared SMARTCOP and SMRT-CP with the Pneumonia Severity Index and CURB-65. The latter assesses community-acquired pneumonia risk based on the presence of confusion, urea nitrogen levels, respiratory rate, blood pressure, and age of 65 years or older. Overall, 10% of the patients needed ICU care, and 5% died within 30 days. The study excluded patients who were likely to die within 12–24 hours and were admitted for palliative care, so mortality was lower than might be expected.

SMARTCOP was simpler and as accurate as two tools already used in predicting the need for ICU care. DR. CHARLES

SAN FRANCISCO — Two new and simple tools may help predict which patients with community-acquired pneumonia are likely to die or to need ICU care, investigators reported in separate presentations at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The tools could help clinicians flag some patients for more intensive treatment and monitoring, whereas others could be managed as outpatients. Adults with community-acquired pneumonia (CAP) and any of four clinical predictors had an increased risk of death within 30 days in a study of 1,525 patients, said Maylee Chen, Pharm.D., at the meeting, which was sponsored by the American Society for Microbiology.

The odds for 30-day mortality nearly tripled in patients with cerebrovascular disease or hypoxemia (defined as partial pressure of arterial oxygen less than 60 mm Hg, ratio of partial pressure of arterial oxygen to fractional inspiratory oxygen less than 300, or oxygen saturation less than 90% by oximetry). The odds for 30-day mortality doubled in patients with coexisting neoplasm or uremia (defined as a BUN of at least 30 mg/dL), said Dr. Chen, who led the study while a fellow at the University of Louisville (Ky.), and now practices at the Queen's Medical Center, Honolulu.

The 30-day mortality rate in the cohort overall was 16%. Without any of the four predictors, 6% of patients with CAP died within 30 days. Death rates within 30 days ranged from 23% to 55% for patients with one of the four clinical predictors.

Cerebrovascular disease, hypoxemia, neoplasm, and uremia are among 20 criteria used in the Pneumonia Severity Index to predict risk. The study validates use of the simplified model for predicting risk of death from community-acquired pneumonia, Dr. Chen said. Patients with the highest risk by the Pneumonia Severity Index (rated class V) were the most likely to die and the most likely to have one or more of the four clinical predictors of death.

Patient data came from the multinational Community-Acquired Pneumonia Organization study. Dr. Chen and her associates also performed a secondary analysis that included 982 patients whose 30-day mortality was unknown—assuming that any patient with an unknown outcome survived—in addition to the 1,525 patients with known outcomes. Each of the four clinical variables remained a significant predictor of 30-day mortality, she said.

In a separate presentation, Dr. Patrick G. P. Charles of Austin Hospital, Heidelberg, Victoria, Australia, described another assessment tool that may predict the need for ICU care of patients with CAP if a planned prospective study validates preliminary findings.

The SMARTCOP assessment tool gauges risk for ICU care by assigning points to patients based on these characteristics:

▸ Systolic blood pressure below 90 mm Hg.

▸ Multilobar chest x-ray involvement.

▸ Albumin less than 3.5 g/dL.

▸ Respiratory rate (at least 30 breaths per minute in patients aged 40 years or older, at least 25 breaths per minute if younger).

▸ Tachycardia of 125 beats per minute, or higher.

▸ Confusion.

▸ Poor oxygenation.

▸ pH below 7.35.

Early data from a study of 849 patients showed the SMARTCOP tool (and an abbreviated version, SMRT-CP) were simpler and as accurate as two tools already used in predicting the need for ICU care, said Dr. Charles and associates, who compared SMARTCOP and SMRT-CP with the Pneumonia Severity Index and CURB-65. The latter assesses community-acquired pneumonia risk based on the presence of confusion, urea nitrogen levels, respiratory rate, blood pressure, and age of 65 years or older. Overall, 10% of the patients needed ICU care, and 5% died within 30 days. The study excluded patients who were likely to die within 12–24 hours and were admitted for palliative care, so mortality was lower than might be expected.

SMARTCOP was simpler and as accurate as two tools already used in predicting the need for ICU care. DR. CHARLES

SAN DIEGO — Several experimental treatments for obesity are being developed as alternatives to Roux-en-Y surgery or gastric banding.

Devices that are placed endoscopically or surgically may someday fill a gap between low-risk, low-effectiveness diet/exercise strategies and the higher-risk procedures, Dr. Jeffrey S. Brooks said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.

Only 2% of obese patients undergo Roux-en-Y surgery or gastric banding. Rates of death after open procedures are 2% within a month of surgery and 5% within 1 year (JAMA 2005;294:1903–6). Laparoscopic procedures lower the overall reported mortality rate for Roux-en-Y and gastric banding procedures to 1% or less, he noted.

Alternative devices being investigated include gastric balloons (to fill stomach space and give the sensation of satiety with less food) and gastric stimulation devices (to stimulate quicker gastric emptying). “At least one of these will hit the streets in 2–3 years,” said Dr. Brooks, a gastroenterologist and chief scientific officer of a company that is developing one of the balloons.

The saline-filled Bioenterics intragastric balloon (BIB) and the air-filled Heliosphere intragastric balloon are in use in some European and South American countries, Mexico, and Canada, he said.

About 2,500 BIBs have been placed in patients in Italy, and studies have ranged from 30 to a few hundred patients.

The BIB contributes to an average weight loss of 15 kg and a five-point decrease in body mass index (BMI) after 6 months, data suggest. The balloon initially causes severe nausea, but the rate of balloon removal in the first few postoperative days is less than 3%, Dr. Brooks said. Overall rates of removal due to intolerance range from 3% to 9%.

The BIB deflates prematurely in up to 29% of cases, depending on the study. Intestinal obstruction has occurred in 0.3%-5% of patients, and 3% of patients have suffered gastric perforations. The device is contraindicated in patients who have previously had gastric surgery, because they are at highest risk for perforation.

Although supposedly adjustable to fit the patient's size requirements, the BIB is “quite difficult” and not practical to adjust, Dr. Brooks said.

The Heliosphere balloon is relatively easy to put in but very difficult to take out, he said. This double-walled polymer balloon is covered with silicone. Placed endoscopically, it gets inflated with 650–750 mL of air. Like the BIB, it is used for 6 months as an adjunct to diet and exercise. The removal rate for intolerance is around 6%, and about 2% of the devices deflate prematurely, preliminary data suggest.

A third endoscopically placed balloon currently being developed by Dr. Brooks' company, Spatz-FGIA Inc., is expected to be adjustable, he said. Studies in animals so far show no migration or gastric perforations. Two other companies (Satiety Inc. and Fulfillium Inc.) have filed patents for gastric balloons, but it's unclear if and when they will start clinical studies.

Two kinds of gastric stimulators are in development. One by Transneuronix Inc. provides continuous stimulation, and one by Metacureh provides intermittent stimulation when food is ingested.

Impressive European results with gastric stimulation have not been matched by early U.S. data, he noted. A randomized trial of the Transneuronix device in 190 patients in 2004 found that 27% in the stimulator group and 16% in the control group had lost at least 20% of excess weight 1 year later.

“I think it will work for some patients,” Dr. Brooks commented.

SAN DIEGO — Several experimental treatments for obesity are being developed as alternatives to Roux-en-Y surgery or gastric banding.

Devices that are placed endoscopically or surgically may someday fill a gap between low-risk, low-effectiveness diet/exercise strategies and the higher-risk procedures, Dr. Jeffrey S. Brooks said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.

Only 2% of obese patients undergo Roux-en-Y surgery or gastric banding. Rates of death after open procedures are 2% within a month of surgery and 5% within 1 year (JAMA 2005;294:1903–6). Laparoscopic procedures lower the overall reported mortality rate for Roux-en-Y and gastric banding procedures to 1% or less, he noted.

Alternative devices being investigated include gastric balloons (to fill stomach space and give the sensation of satiety with less food) and gastric stimulation devices (to stimulate quicker gastric emptying). “At least one of these will hit the streets in 2–3 years,” said Dr. Brooks, a gastroenterologist and chief scientific officer of a company that is developing one of the balloons.

The saline-filled Bioenterics intragastric balloon (BIB) and the air-filled Heliosphere intragastric balloon are in use in some European and South American countries, Mexico, and Canada, he said.

About 2,500 BIBs have been placed in patients in Italy, and studies have ranged from 30 to a few hundred patients.

The BIB contributes to an average weight loss of 15 kg and a five-point decrease in body mass index (BMI) after 6 months, data suggest. The balloon initially causes severe nausea, but the rate of balloon removal in the first few postoperative days is less than 3%, Dr. Brooks said. Overall rates of removal due to intolerance range from 3% to 9%.

The BIB deflates prematurely in up to 29% of cases, depending on the study. Intestinal obstruction has occurred in 0.3%-5% of patients, and 3% of patients have suffered gastric perforations. The device is contraindicated in patients who have previously had gastric surgery, because they are at highest risk for perforation.

Although supposedly adjustable to fit the patient's size requirements, the BIB is “quite difficult” and not practical to adjust, Dr. Brooks said.

The Heliosphere balloon is relatively easy to put in but very difficult to take out, he said. This double-walled polymer balloon is covered with silicone. Placed endoscopically, it gets inflated with 650–750 mL of air. Like the BIB, it is used for 6 months as an adjunct to diet and exercise. The removal rate for intolerance is around 6%, and about 2% of the devices deflate prematurely, preliminary data suggest.

A third endoscopically placed balloon currently being developed by Dr. Brooks' company, Spatz-FGIA Inc., is expected to be adjustable, he said. Studies in animals so far show no migration or gastric perforations. Two other companies (Satiety Inc. and Fulfillium Inc.) have filed patents for gastric balloons, but it's unclear if and when they will start clinical studies.

Two kinds of gastric stimulators are in development. One by Transneuronix Inc. provides continuous stimulation, and one by Metacureh provides intermittent stimulation when food is ingested.

Impressive European results with gastric stimulation have not been matched by early U.S. data, he noted. A randomized trial of the Transneuronix device in 190 patients in 2004 found that 27% in the stimulator group and 16% in the control group had lost at least 20% of excess weight 1 year later.

“I think it will work for some patients,” Dr. Brooks commented.

SAN DIEGO — Several experimental treatments for obesity are being developed as alternatives to Roux-en-Y surgery or gastric banding.

Devices that are placed endoscopically or surgically may someday fill a gap between low-risk, low-effectiveness diet/exercise strategies and the higher-risk procedures, Dr. Jeffrey S. Brooks said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.

Only 2% of obese patients undergo Roux-en-Y surgery or gastric banding. Rates of death after open procedures are 2% within a month of surgery and 5% within 1 year (JAMA 2005;294:1903–6). Laparoscopic procedures lower the overall reported mortality rate for Roux-en-Y and gastric banding procedures to 1% or less, he noted.

Alternative devices being investigated include gastric balloons (to fill stomach space and give the sensation of satiety with less food) and gastric stimulation devices (to stimulate quicker gastric emptying). “At least one of these will hit the streets in 2–3 years,” said Dr. Brooks, a gastroenterologist and chief scientific officer of a company that is developing one of the balloons.

The saline-filled Bioenterics intragastric balloon (BIB) and the air-filled Heliosphere intragastric balloon are in use in some European and South American countries, Mexico, and Canada, he said.

About 2,500 BIBs have been placed in patients in Italy, and studies have ranged from 30 to a few hundred patients.

The BIB contributes to an average weight loss of 15 kg and a five-point decrease in body mass index (BMI) after 6 months, data suggest. The balloon initially causes severe nausea, but the rate of balloon removal in the first few postoperative days is less than 3%, Dr. Brooks said. Overall rates of removal due to intolerance range from 3% to 9%.

The BIB deflates prematurely in up to 29% of cases, depending on the study. Intestinal obstruction has occurred in 0.3%-5% of patients, and 3% of patients have suffered gastric perforations. The device is contraindicated in patients who have previously had gastric surgery, because they are at highest risk for perforation.

Although supposedly adjustable to fit the patient's size requirements, the BIB is “quite difficult” and not practical to adjust, Dr. Brooks said.

The Heliosphere balloon is relatively easy to put in but very difficult to take out, he said. This double-walled polymer balloon is covered with silicone. Placed endoscopically, it gets inflated with 650–750 mL of air. Like the BIB, it is used for 6 months as an adjunct to diet and exercise. The removal rate for intolerance is around 6%, and about 2% of the devices deflate prematurely, preliminary data suggest.

A third endoscopically placed balloon currently being developed by Dr. Brooks' company, Spatz-FGIA Inc., is expected to be adjustable, he said. Studies in animals so far show no migration or gastric perforations. Two other companies (Satiety Inc. and Fulfillium Inc.) have filed patents for gastric balloons, but it's unclear if and when they will start clinical studies.

Two kinds of gastric stimulators are in development. One by Transneuronix Inc. provides continuous stimulation, and one by Metacureh provides intermittent stimulation when food is ingested.

Impressive European results with gastric stimulation have not been matched by early U.S. data, he noted. A randomized trial of the Transneuronix device in 190 patients in 2004 found that 27% in the stimulator group and 16% in the control group had lost at least 20% of excess weight 1 year later.

“I think it will work for some patients,” Dr. Brooks commented.

SEATTLE — Low-dose aspirin did not reduce the beneficial effects of ACE inhibitors in patients with atrial fibrillation and a history of heart failure, a subset analysis of 2,031 patients found.

The analysis addressed recurring concerns that aspirin use attenuates the effects of ACE inhibitors in heart failure patients and supported the use of both low-dose aspirin and an ACE inhibitor when indications for both treatments exist, Dr. Akshay S. Desai said at the annual meeting of the Heart Failure Society of America.

Dr. Desai and associates studied data from the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE-W). The prospective, open-label study randomized patients with atrial fibrillation to combination antiplatelet therapy with clopidogrel and 75–100 mg/day of aspirin or to oral anticoagulation with warfarin. ACTIVE-W was discontinued early because warfarin clearly reduced the risk of MI, vascular events, or death.

Compared with all ACTIVE-W patients, the 2,031 patients with prior heart failure were more likely to be hypertensive or diabetic; more likely to have left ventricular dysfunction, a prior MI, or coronary disease; and more likely to be on an ACE inhibitor or angiotensin receptor blocker at baseline. In general, heart failure increases the risk for thromboembolic events, and the patients with prior heart failure in ACTIVE-W were twice as likely to develop MI, vascular events, or death, compared with those with no history of heart failure.

Notably, however, the relative benefits of antiplatelet or anticoagulant therapy to prevent thromboembolic events did not differ significantly either in ACTIVE-W patients as a whole or in the subset of patients with heart failure, said Dr. Desai of Brigham and Women's Hospital, Boston. The risk of bleeding complications also did not differ between treatment groups.

Looking at the composite end point of death or hospitalization for heart failure, patients with a history of heart failure had triple the risk, compared with non-heart failure patients, but again there was no significant difference between the antiplatelet and anticoagulant treatment groups.

The investigators stratified patients with heart failure based on whether they used an ACE inhibitor at baseline, expecting to see a greater relative benefit in the warfarin group if aspirin attenuated the effects of ACE inhibitors. They found no statistically significant differences between the antiplatelet and anticoagulation groups, suggesting no interaction between aspirin and ACE inhibitors.

Some heart failure patients in the warfarin group also were on ACE inhibitors at baseline, which might have limited the power to detect an aspirin-ACE inhibitor interaction, so they repeated the analyses after excluding patients on an ACE inhibitor at baseline who were randomized to warfarin. Again, they found no significant aspirin-ACE inhibitor interaction.

Concerns about a possible interaction between aspirin and ACE inhibitors began with a 1992 hemodynamic study, later confirmed by others, showing that coadministration of enalapril and aspirin in 18 patients with severe heart failure attenuated some of the hemodynamic effects of ACE inhibitors on systemic vascular resistance.

A retrospective analysis of the Studies of Left Ventricular Dysfunction (SOLVD) trial suggested that patients on enalapril were more likely to die if they also took aspirin. A similar finding came from a retrospective analysis of the Cooperative New Scandinavian Enalapril Survival Study (CONSENSUS) II. A large meta-analysis of ACE inhibitor trials, however, found no significant increase in death or hospitalization for heart failure with concurrent use of aspirin, Dr. Desai said.

“Like previous analyses of this topic, ours is not definitive,” but it provides some reassurance to clinicians who may be concerned that aspirin interferes with ACE inhibitors, he said. Dr. Desai has no relationships with the companies that make the drugs he discussed.

SEATTLE — Low-dose aspirin did not reduce the beneficial effects of ACE inhibitors in patients with atrial fibrillation and a history of heart failure, a subset analysis of 2,031 patients found.

The analysis addressed recurring concerns that aspirin use attenuates the effects of ACE inhibitors in heart failure patients and supported the use of both low-dose aspirin and an ACE inhibitor when indications for both treatments exist, Dr. Akshay S. Desai said at the annual meeting of the Heart Failure Society of America.

Dr. Desai and associates studied data from the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE-W). The prospective, open-label study randomized patients with atrial fibrillation to combination antiplatelet therapy with clopidogrel and 75–100 mg/day of aspirin or to oral anticoagulation with warfarin. ACTIVE-W was discontinued early because warfarin clearly reduced the risk of MI, vascular events, or death.

Compared with all ACTIVE-W patients, the 2,031 patients with prior heart failure were more likely to be hypertensive or diabetic; more likely to have left ventricular dysfunction, a prior MI, or coronary disease; and more likely to be on an ACE inhibitor or angiotensin receptor blocker at baseline. In general, heart failure increases the risk for thromboembolic events, and the patients with prior heart failure in ACTIVE-W were twice as likely to develop MI, vascular events, or death, compared with those with no history of heart failure.

Notably, however, the relative benefits of antiplatelet or anticoagulant therapy to prevent thromboembolic events did not differ significantly either in ACTIVE-W patients as a whole or in the subset of patients with heart failure, said Dr. Desai of Brigham and Women's Hospital, Boston. The risk of bleeding complications also did not differ between treatment groups.

Looking at the composite end point of death or hospitalization for heart failure, patients with a history of heart failure had triple the risk, compared with non-heart failure patients, but again there was no significant difference between the antiplatelet and anticoagulant treatment groups.

The investigators stratified patients with heart failure based on whether they used an ACE inhibitor at baseline, expecting to see a greater relative benefit in the warfarin group if aspirin attenuated the effects of ACE inhibitors. They found no statistically significant differences between the antiplatelet and anticoagulation groups, suggesting no interaction between aspirin and ACE inhibitors.

Some heart failure patients in the warfarin group also were on ACE inhibitors at baseline, which might have limited the power to detect an aspirin-ACE inhibitor interaction, so they repeated the analyses after excluding patients on an ACE inhibitor at baseline who were randomized to warfarin. Again, they found no significant aspirin-ACE inhibitor interaction.

Concerns about a possible interaction between aspirin and ACE inhibitors began with a 1992 hemodynamic study, later confirmed by others, showing that coadministration of enalapril and aspirin in 18 patients with severe heart failure attenuated some of the hemodynamic effects of ACE inhibitors on systemic vascular resistance.

A retrospective analysis of the Studies of Left Ventricular Dysfunction (SOLVD) trial suggested that patients on enalapril were more likely to die if they also took aspirin. A similar finding came from a retrospective analysis of the Cooperative New Scandinavian Enalapril Survival Study (CONSENSUS) II. A large meta-analysis of ACE inhibitor trials, however, found no significant increase in death or hospitalization for heart failure with concurrent use of aspirin, Dr. Desai said.

“Like previous analyses of this topic, ours is not definitive,” but it provides some reassurance to clinicians who may be concerned that aspirin interferes with ACE inhibitors, he said. Dr. Desai has no relationships with the companies that make the drugs he discussed.

SEATTLE — Low-dose aspirin did not reduce the beneficial effects of ACE inhibitors in patients with atrial fibrillation and a history of heart failure, a subset analysis of 2,031 patients found.

The analysis addressed recurring concerns that aspirin use attenuates the effects of ACE inhibitors in heart failure patients and supported the use of both low-dose aspirin and an ACE inhibitor when indications for both treatments exist, Dr. Akshay S. Desai said at the annual meeting of the Heart Failure Society of America.

Dr. Desai and associates studied data from the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE-W). The prospective, open-label study randomized patients with atrial fibrillation to combination antiplatelet therapy with clopidogrel and 75–100 mg/day of aspirin or to oral anticoagulation with warfarin. ACTIVE-W was discontinued early because warfarin clearly reduced the risk of MI, vascular events, or death.

Compared with all ACTIVE-W patients, the 2,031 patients with prior heart failure were more likely to be hypertensive or diabetic; more likely to have left ventricular dysfunction, a prior MI, or coronary disease; and more likely to be on an ACE inhibitor or angiotensin receptor blocker at baseline. In general, heart failure increases the risk for thromboembolic events, and the patients with prior heart failure in ACTIVE-W were twice as likely to develop MI, vascular events, or death, compared with those with no history of heart failure.

Notably, however, the relative benefits of antiplatelet or anticoagulant therapy to prevent thromboembolic events did not differ significantly either in ACTIVE-W patients as a whole or in the subset of patients with heart failure, said Dr. Desai of Brigham and Women's Hospital, Boston. The risk of bleeding complications also did not differ between treatment groups.

Looking at the composite end point of death or hospitalization for heart failure, patients with a history of heart failure had triple the risk, compared with non-heart failure patients, but again there was no significant difference between the antiplatelet and anticoagulant treatment groups.

The investigators stratified patients with heart failure based on whether they used an ACE inhibitor at baseline, expecting to see a greater relative benefit in the warfarin group if aspirin attenuated the effects of ACE inhibitors. They found no statistically significant differences between the antiplatelet and anticoagulation groups, suggesting no interaction between aspirin and ACE inhibitors.

Some heart failure patients in the warfarin group also were on ACE inhibitors at baseline, which might have limited the power to detect an aspirin-ACE inhibitor interaction, so they repeated the analyses after excluding patients on an ACE inhibitor at baseline who were randomized to warfarin. Again, they found no significant aspirin-ACE inhibitor interaction.

Concerns about a possible interaction between aspirin and ACE inhibitors began with a 1992 hemodynamic study, later confirmed by others, showing that coadministration of enalapril and aspirin in 18 patients with severe heart failure attenuated some of the hemodynamic effects of ACE inhibitors on systemic vascular resistance.

A retrospective analysis of the Studies of Left Ventricular Dysfunction (SOLVD) trial suggested that patients on enalapril were more likely to die if they also took aspirin. A similar finding came from a retrospective analysis of the Cooperative New Scandinavian Enalapril Survival Study (CONSENSUS) II. A large meta-analysis of ACE inhibitor trials, however, found no significant increase in death or hospitalization for heart failure with concurrent use of aspirin, Dr. Desai said.

“Like previous analyses of this topic, ours is not definitive,” but it provides some reassurance to clinicians who may be concerned that aspirin interferes with ACE inhibitors, he said. Dr. Desai has no relationships with the companies that make the drugs he discussed.

SEATTLE — Cardiologists outperformed internists, family physicians, and other specialists in meeting the measures of care for hospitalized patients with heart failure prescribed by the Joint Commission on Accreditation of Healthcare Organizations, Kismet D. Rasmusson reported.

A study of care within the 20-hospital Intermountain Healthcare system, which handled 2,000 admissions for a primary diagnosis of heart failure in 2005, assessed documentation of three aspects of care mandated by the Joint Commission (JCAHO) for evidence-based care of heart failure. Intermountain Healthcare employs about 400 physicians, mainly in primary care, and is affiliated with 2,500 more physicians, mainly specialists.

Results showed that internists cared for 31% of patients admitted for the first time with a primary diagnosis of heart failure during 2002–2006. Family physicians handled 19%, cardiologists or thoracic surgeons provided 22% of care, and other specialists handled the remainder of care for heart failure, she and her associates reported in a poster presentation.

Overall, 62% of cardiologists documented compliance with all three measures of heart failure care, compared with 43% of noncardiologists, said Ms. Rasmusson, a family nurse practitioner at LDS Hospital, Salt Lake City.

Noncardiologists were more likely to comply with only one, two, or none of the measures, documentation suggested.

The JCAHO requires documentation of four steps in caring for hospitalized heart failure patients:

1. Measurement of left ventricular function in the past, or planned measurement after discharge.

2. Prescription of an ACE inhibitor or an angiotensin receptor blocker when the left ventricular ejection fraction is 40% or lower, unless the drugs are contraindicated.

3. Providing self-management education to patients.

4. Providing smoking cessation counseling (the study did not include this measure because of the low numbers of smokers).

Previous studies have shown that compliance with these measures is associated with improved patient outcomes. “Health systems need to either increase the numbers of cardiologists providing heart failure care or improve care provided by noncardiologists,” the investigators concluded.

SEATTLE — Cardiologists outperformed internists, family physicians, and other specialists in meeting the measures of care for hospitalized patients with heart failure prescribed by the Joint Commission on Accreditation of Healthcare Organizations, Kismet D. Rasmusson reported.

A study of care within the 20-hospital Intermountain Healthcare system, which handled 2,000 admissions for a primary diagnosis of heart failure in 2005, assessed documentation of three aspects of care mandated by the Joint Commission (JCAHO) for evidence-based care of heart failure. Intermountain Healthcare employs about 400 physicians, mainly in primary care, and is affiliated with 2,500 more physicians, mainly specialists.

Results showed that internists cared for 31% of patients admitted for the first time with a primary diagnosis of heart failure during 2002–2006. Family physicians handled 19%, cardiologists or thoracic surgeons provided 22% of care, and other specialists handled the remainder of care for heart failure, she and her associates reported in a poster presentation.

Overall, 62% of cardiologists documented compliance with all three measures of heart failure care, compared with 43% of noncardiologists, said Ms. Rasmusson, a family nurse practitioner at LDS Hospital, Salt Lake City.

Noncardiologists were more likely to comply with only one, two, or none of the measures, documentation suggested.

The JCAHO requires documentation of four steps in caring for hospitalized heart failure patients:

1. Measurement of left ventricular function in the past, or planned measurement after discharge.

2. Prescription of an ACE inhibitor or an angiotensin receptor blocker when the left ventricular ejection fraction is 40% or lower, unless the drugs are contraindicated.

3. Providing self-management education to patients.

4. Providing smoking cessation counseling (the study did not include this measure because of the low numbers of smokers).

Previous studies have shown that compliance with these measures is associated with improved patient outcomes. “Health systems need to either increase the numbers of cardiologists providing heart failure care or improve care provided by noncardiologists,” the investigators concluded.

SEATTLE — Cardiologists outperformed internists, family physicians, and other specialists in meeting the measures of care for hospitalized patients with heart failure prescribed by the Joint Commission on Accreditation of Healthcare Organizations, Kismet D. Rasmusson reported.

A study of care within the 20-hospital Intermountain Healthcare system, which handled 2,000 admissions for a primary diagnosis of heart failure in 2005, assessed documentation of three aspects of care mandated by the Joint Commission (JCAHO) for evidence-based care of heart failure. Intermountain Healthcare employs about 400 physicians, mainly in primary care, and is affiliated with 2,500 more physicians, mainly specialists.

Results showed that internists cared for 31% of patients admitted for the first time with a primary diagnosis of heart failure during 2002–2006. Family physicians handled 19%, cardiologists or thoracic surgeons provided 22% of care, and other specialists handled the remainder of care for heart failure, she and her associates reported in a poster presentation.

Overall, 62% of cardiologists documented compliance with all three measures of heart failure care, compared with 43% of noncardiologists, said Ms. Rasmusson, a family nurse practitioner at LDS Hospital, Salt Lake City.

Noncardiologists were more likely to comply with only one, two, or none of the measures, documentation suggested.

The JCAHO requires documentation of four steps in caring for hospitalized heart failure patients:

1. Measurement of left ventricular function in the past, or planned measurement after discharge.

2. Prescription of an ACE inhibitor or an angiotensin receptor blocker when the left ventricular ejection fraction is 40% or lower, unless the drugs are contraindicated.

3. Providing self-management education to patients.

4. Providing smoking cessation counseling (the study did not include this measure because of the low numbers of smokers).

Previous studies have shown that compliance with these measures is associated with improved patient outcomes. “Health systems need to either increase the numbers of cardiologists providing heart failure care or improve care provided by noncardiologists,” the investigators concluded.

MONTEREY, CALIF. — Two (2%) of 98 pregnant women being admitted for labor or a scheduled C-section were colonized with methicillin-resistant Staphylococcus aureus in a pilot study, Dr. Richard H. Beigi reported in a poster presentation at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The results of the study are consistent with a 2%–4% colonization rate for methicillin-resistant S. aureus (MRSA) found in some populations, though higher rates have been seen in select populations. These are among the first data on MRSA in women entering labor and delivery wards, said Dr. Beigi, who performed the study at MetroHealth Medical Center, Cleveland, and now is at Magee-Women's Hospital, Pittsburgh.

“It emphasizes the fact that we need to have very good hand hygiene,” he said in an interview at the poster session. The study was funded by Steris Corp., which makes a hand hygiene product.

The 2% rate provides a baseline for comparisons as the incidence of MRSA is tracked in labor and delivery over time. Ongoing surveillance is warranted given the increasing rates of MRSA in other specialties and the limited number of effective drug treatments for complications of MRSA infection, said Dr. Beigi and his associates.

Of the 96 women, 21 (22%) had S. aureus detected in samples from the anterior nares. Two (10%) of the 21 with S. aureus had MRSA. One of the women with MRSA worked in a hospital, and the other had no contact with a hospital or hospital workers as a potential source for her MRSA colonization.

Eight (38%) of the 21 isolates with S. aureus demonstrated inducible clindamycin resistance, and one of these was a strain with MRSA. The clinical implications of this are unclear, but MRSA plus clindamycin resistance would further narrow choices for therapy.

In a subset of 28 women who also had cultures obtained from the outer third of the vagina, 23 (82%) had concordant findings, meaning that if they were positive or negative for S. aureus in one anatomical site, they had the same result at the other site.

Six postpartum infections potentially were attributable to S. aureus—two cases of mastitis and four wound infections after C-section. Postpartum infection rates were twice as high in women with S. aureus (10%), compared with uncolonized women (5%), but the difference was not statistically significant. A larger study might show a significant difference in infection rates, Dr. Beigi suggested.

MONTEREY, CALIF. — Two (2%) of 98 pregnant women being admitted for labor or a scheduled C-section were colonized with methicillin-resistant Staphylococcus aureus in a pilot study, Dr. Richard H. Beigi reported in a poster presentation at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The results of the study are consistent with a 2%–4% colonization rate for methicillin-resistant S. aureus (MRSA) found in some populations, though higher rates have been seen in select populations. These are among the first data on MRSA in women entering labor and delivery wards, said Dr. Beigi, who performed the study at MetroHealth Medical Center, Cleveland, and now is at Magee-Women's Hospital, Pittsburgh.

“It emphasizes the fact that we need to have very good hand hygiene,” he said in an interview at the poster session. The study was funded by Steris Corp., which makes a hand hygiene product.

The 2% rate provides a baseline for comparisons as the incidence of MRSA is tracked in labor and delivery over time. Ongoing surveillance is warranted given the increasing rates of MRSA in other specialties and the limited number of effective drug treatments for complications of MRSA infection, said Dr. Beigi and his associates.

Of the 96 women, 21 (22%) had S. aureus detected in samples from the anterior nares. Two (10%) of the 21 with S. aureus had MRSA. One of the women with MRSA worked in a hospital, and the other had no contact with a hospital or hospital workers as a potential source for her MRSA colonization.

Eight (38%) of the 21 isolates with S. aureus demonstrated inducible clindamycin resistance, and one of these was a strain with MRSA. The clinical implications of this are unclear, but MRSA plus clindamycin resistance would further narrow choices for therapy.

In a subset of 28 women who also had cultures obtained from the outer third of the vagina, 23 (82%) had concordant findings, meaning that if they were positive or negative for S. aureus in one anatomical site, they had the same result at the other site.

Six postpartum infections potentially were attributable to S. aureus—two cases of mastitis and four wound infections after C-section. Postpartum infection rates were twice as high in women with S. aureus (10%), compared with uncolonized women (5%), but the difference was not statistically significant. A larger study might show a significant difference in infection rates, Dr. Beigi suggested.

MONTEREY, CALIF. — Two (2%) of 98 pregnant women being admitted for labor or a scheduled C-section were colonized with methicillin-resistant Staphylococcus aureus in a pilot study, Dr. Richard H. Beigi reported in a poster presentation at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The results of the study are consistent with a 2%–4% colonization rate for methicillin-resistant S. aureus (MRSA) found in some populations, though higher rates have been seen in select populations. These are among the first data on MRSA in women entering labor and delivery wards, said Dr. Beigi, who performed the study at MetroHealth Medical Center, Cleveland, and now is at Magee-Women's Hospital, Pittsburgh.

“It emphasizes the fact that we need to have very good hand hygiene,” he said in an interview at the poster session. The study was funded by Steris Corp., which makes a hand hygiene product.

The 2% rate provides a baseline for comparisons as the incidence of MRSA is tracked in labor and delivery over time. Ongoing surveillance is warranted given the increasing rates of MRSA in other specialties and the limited number of effective drug treatments for complications of MRSA infection, said Dr. Beigi and his associates.

Of the 96 women, 21 (22%) had S. aureus detected in samples from the anterior nares. Two (10%) of the 21 with S. aureus had MRSA. One of the women with MRSA worked in a hospital, and the other had no contact with a hospital or hospital workers as a potential source for her MRSA colonization.

Eight (38%) of the 21 isolates with S. aureus demonstrated inducible clindamycin resistance, and one of these was a strain with MRSA. The clinical implications of this are unclear, but MRSA plus clindamycin resistance would further narrow choices for therapy.

In a subset of 28 women who also had cultures obtained from the outer third of the vagina, 23 (82%) had concordant findings, meaning that if they were positive or negative for S. aureus in one anatomical site, they had the same result at the other site.

Six postpartum infections potentially were attributable to S. aureus—two cases of mastitis and four wound infections after C-section. Postpartum infection rates were twice as high in women with S. aureus (10%), compared with uncolonized women (5%), but the difference was not statistically significant. A larger study might show a significant difference in infection rates, Dr. Beigi suggested.

SAN FRANCISCO — Tigecycline appeared to be comparable in efficacy and tolerability to levofloxacin in treating community-acquired pneumonia in two phase III studies of 891 hospitalized patients needing intravenous therapy, Dr. Gary Dukart reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

If approved, tigecycline would be the first glycylcycline available to treat pneumonia, said Dr. Dukart of Wyeth Research, Collegeville, Pa., and his associates. Wyeth markets the drug, which is approved in 40 countries including the United States for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections. Tigecycline is a broad-spectrum antibiotic with in vitro activity against gram-positive, gram-negative, anaerobic, and atypical bacteria, including some resistant strains.

A separate study of tigecycline therapy for hospital-acquired pneumonia is ongoing. Once that is complete, the company plans to apply in 2007 for approval of tigecycline to treat community- or hospital-acquired pneumonias, he said.

Patients in the multicenter, double-blind studies of community-acquired pneumonia were randomized to 7–10 days of treatment with intravenous tigecycline (100 mg initially, then 50 mg every 12 hours) or intravenous levofloxacin. Dosages of levofloxacin differed between the two trials. In one, patients received 500 mg every 24 hours. In the other, they got 500 mg every 12 or 24 hours at the discretion of the physician and based on local practice. In one trial, patients who showed improvements in their signs and symptoms of pneumonia could be switched after at least 3 days of intravenous therapy to oral levofloxacin for the duration of therapy.

The mean duration of treatment in both groups was 10 days. The mean hospital stay in both groups was 6 days.

Among 846 patients who received at least one dose of medication (a modified intent-to-treat population), 81% on tigecycline and 80% on levofloxacin were considered cured. Among 574 “evaluable” patients who were assessed for cure between 7 and 23 days after the last dose of medication, 90% in the tigecycline group and 86% in the levofloxacin group were cured. The differences between groups were not significant.

Among 40 patients with pneumonia due to documented Streptococcus pneumoniae infection, tigecycline cured 20 (91%) of 22 patients and levofloxacin cured 13 (72%) of 18. The rate of discontinuing medication because of side effects did not differ significantly between groups—6% with tigecycline and 8% with levofloxacin. Serious adverse events occurred in 10% with tigecycline and 11% with levofloxacin. In each group, 3% of patients died, but the deaths were not considered related to the medications.

Drug-related adverse events affected 48% on tigecycline and 37% on levofloxacin, a significant difference. A significantly greater proportion of patients in the tigecycline group experienced nausea or vomiting (24% and 16%, respectively), compared with the levofloxacin group (6% and 3%). Patients in the tigecycline group were significantly less likely to have elevated ALT or AST levels (3% and 2%), compared with the levofloxacin group (6% and 6%). Other common side effects were comparable between groups.

The conference was sponsored by the American Society for Microbiology.

SAN FRANCISCO — Tigecycline appeared to be comparable in efficacy and tolerability to levofloxacin in treating community-acquired pneumonia in two phase III studies of 891 hospitalized patients needing intravenous therapy, Dr. Gary Dukart reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

If approved, tigecycline would be the first glycylcycline available to treat pneumonia, said Dr. Dukart of Wyeth Research, Collegeville, Pa., and his associates. Wyeth markets the drug, which is approved in 40 countries including the United States for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections. Tigecycline is a broad-spectrum antibiotic with in vitro activity against gram-positive, gram-negative, anaerobic, and atypical bacteria, including some resistant strains.

A separate study of tigecycline therapy for hospital-acquired pneumonia is ongoing. Once that is complete, the company plans to apply in 2007 for approval of tigecycline to treat community- or hospital-acquired pneumonias, he said.

Patients in the multicenter, double-blind studies of community-acquired pneumonia were randomized to 7–10 days of treatment with intravenous tigecycline (100 mg initially, then 50 mg every 12 hours) or intravenous levofloxacin. Dosages of levofloxacin differed between the two trials. In one, patients received 500 mg every 24 hours. In the other, they got 500 mg every 12 or 24 hours at the discretion of the physician and based on local practice. In one trial, patients who showed improvements in their signs and symptoms of pneumonia could be switched after at least 3 days of intravenous therapy to oral levofloxacin for the duration of therapy.

The mean duration of treatment in both groups was 10 days. The mean hospital stay in both groups was 6 days.

Among 846 patients who received at least one dose of medication (a modified intent-to-treat population), 81% on tigecycline and 80% on levofloxacin were considered cured. Among 574 “evaluable” patients who were assessed for cure between 7 and 23 days after the last dose of medication, 90% in the tigecycline group and 86% in the levofloxacin group were cured. The differences between groups were not significant.

Among 40 patients with pneumonia due to documented Streptococcus pneumoniae infection, tigecycline cured 20 (91%) of 22 patients and levofloxacin cured 13 (72%) of 18. The rate of discontinuing medication because of side effects did not differ significantly between groups—6% with tigecycline and 8% with levofloxacin. Serious adverse events occurred in 10% with tigecycline and 11% with levofloxacin. In each group, 3% of patients died, but the deaths were not considered related to the medications.

Drug-related adverse events affected 48% on tigecycline and 37% on levofloxacin, a significant difference. A significantly greater proportion of patients in the tigecycline group experienced nausea or vomiting (24% and 16%, respectively), compared with the levofloxacin group (6% and 3%). Patients in the tigecycline group were significantly less likely to have elevated ALT or AST levels (3% and 2%), compared with the levofloxacin group (6% and 6%). Other common side effects were comparable between groups.

The conference was sponsored by the American Society for Microbiology.

SAN FRANCISCO — Tigecycline appeared to be comparable in efficacy and tolerability to levofloxacin in treating community-acquired pneumonia in two phase III studies of 891 hospitalized patients needing intravenous therapy, Dr. Gary Dukart reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

If approved, tigecycline would be the first glycylcycline available to treat pneumonia, said Dr. Dukart of Wyeth Research, Collegeville, Pa., and his associates. Wyeth markets the drug, which is approved in 40 countries including the United States for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections. Tigecycline is a broad-spectrum antibiotic with in vitro activity against gram-positive, gram-negative, anaerobic, and atypical bacteria, including some resistant strains.

A separate study of tigecycline therapy for hospital-acquired pneumonia is ongoing. Once that is complete, the company plans to apply in 2007 for approval of tigecycline to treat community- or hospital-acquired pneumonias, he said.

Patients in the multicenter, double-blind studies of community-acquired pneumonia were randomized to 7–10 days of treatment with intravenous tigecycline (100 mg initially, then 50 mg every 12 hours) or intravenous levofloxacin. Dosages of levofloxacin differed between the two trials. In one, patients received 500 mg every 24 hours. In the other, they got 500 mg every 12 or 24 hours at the discretion of the physician and based on local practice. In one trial, patients who showed improvements in their signs and symptoms of pneumonia could be switched after at least 3 days of intravenous therapy to oral levofloxacin for the duration of therapy.

The mean duration of treatment in both groups was 10 days. The mean hospital stay in both groups was 6 days.

Among 846 patients who received at least one dose of medication (a modified intent-to-treat population), 81% on tigecycline and 80% on levofloxacin were considered cured. Among 574 “evaluable” patients who were assessed for cure between 7 and 23 days after the last dose of medication, 90% in the tigecycline group and 86% in the levofloxacin group were cured. The differences between groups were not significant.

Among 40 patients with pneumonia due to documented Streptococcus pneumoniae infection, tigecycline cured 20 (91%) of 22 patients and levofloxacin cured 13 (72%) of 18. The rate of discontinuing medication because of side effects did not differ significantly between groups—6% with tigecycline and 8% with levofloxacin. Serious adverse events occurred in 10% with tigecycline and 11% with levofloxacin. In each group, 3% of patients died, but the deaths were not considered related to the medications.

Drug-related adverse events affected 48% on tigecycline and 37% on levofloxacin, a significant difference. A significantly greater proportion of patients in the tigecycline group experienced nausea or vomiting (24% and 16%, respectively), compared with the levofloxacin group (6% and 3%). Patients in the tigecycline group were significantly less likely to have elevated ALT or AST levels (3% and 2%), compared with the levofloxacin group (6% and 6%). Other common side effects were comparable between groups.

The conference was sponsored by the American Society for Microbiology.

SAN FRANCISCO — An experimental fluoroquinolone compared favorably with amoxicillin or ceftriaxone for the treatment of community-acquired pneumonia in separate randomized, double-blind phase III trials, investigators reported in poster presentations at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

One study of 308 outpatients in Europe and Russia with mild to moderate community-acquired pneumonia showed similar response rates in patients given 5 days of oral garenoxacin or 10 days of oral amoxicillin, reported Dr. Hetty Waskin of Schering-Plough Research Institute, Kenilworth, N.J. The company is developing garenoxacin and funded the study. The lead investigator in the study was Dr. N. Mogulkoc of Ege University, Izmir, Turkey.

Evaluations that were conducted 7–14 days after completing therapy showed clinical responses in 91% of patients randomized to once-daily doses of 400 mg garenoxacin and in 87% of patients given amoxicillin 1 g t.i.d. The drugs eradicated pneumonia bacteria in 88% of the garenoxacin group and 91% of the amoxicillin group.

Drug-related adverse events—most commonly diarrhea, headache, abdominal pain, and nausea—were seen in 13% of patients in the garenoxacin group and 12% of those in the amoxicillin group.

The second study of 406 hospitalized patients with community-acquired pneumonia showed an 88% clinical cure rate in 328 evaluable patients regardless of treatment group. Patients were randomized to receive either IV garenoxacin 400 mg/day with possible step-down to oral garenoxacin 400 mg/day or IV ceftriaxone 1–2 g/day with possible step-down to oral clarithromycin 500 mg b.i.d. If clinicians suspected atypical pneumonia, patients in the ceftriaxone group also could receive IV erythromycin 0.5–1 g every 6 hours.

Patients were treated for 7–14 days and evaluated for cure 7–14 days after completing therapy, said Dr. Mark E. Dowell of Casper, Wyo., the study's primary investigator. He has no other relationship with Schering-Plough except that the company funded the study and a company employee (Dr. Waskin) was a coinvestigator.

Bacterial eradication rates were 86% for the garenoxacin group and 89% for the ceftriaxone group.

Schering-Plough hopes to win European approval for the drug for community-acquired pneumonia in 2007, but will be looking for a marketing partner to pursue approval of the drug in the United States, Dr. Waskin said.

The conference was sponsored by the American Society for Microbiology.

SAN FRANCISCO — An experimental fluoroquinolone compared favorably with amoxicillin or ceftriaxone for the treatment of community-acquired pneumonia in separate randomized, double-blind phase III trials, investigators reported in poster presentations at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

One study of 308 outpatients in Europe and Russia with mild to moderate community-acquired pneumonia showed similar response rates in patients given 5 days of oral garenoxacin or 10 days of oral amoxicillin, reported Dr. Hetty Waskin of Schering-Plough Research Institute, Kenilworth, N.J. The company is developing garenoxacin and funded the study. The lead investigator in the study was Dr. N. Mogulkoc of Ege University, Izmir, Turkey.

Evaluations that were conducted 7–14 days after completing therapy showed clinical responses in 91% of patients randomized to once-daily doses of 400 mg garenoxacin and in 87% of patients given amoxicillin 1 g t.i.d. The drugs eradicated pneumonia bacteria in 88% of the garenoxacin group and 91% of the amoxicillin group.

Drug-related adverse events—most commonly diarrhea, headache, abdominal pain, and nausea—were seen in 13% of patients in the garenoxacin group and 12% of those in the amoxicillin group.

The second study of 406 hospitalized patients with community-acquired pneumonia showed an 88% clinical cure rate in 328 evaluable patients regardless of treatment group. Patients were randomized to receive either IV garenoxacin 400 mg/day with possible step-down to oral garenoxacin 400 mg/day or IV ceftriaxone 1–2 g/day with possible step-down to oral clarithromycin 500 mg b.i.d. If clinicians suspected atypical pneumonia, patients in the ceftriaxone group also could receive IV erythromycin 0.5–1 g every 6 hours.

Patients were treated for 7–14 days and evaluated for cure 7–14 days after completing therapy, said Dr. Mark E. Dowell of Casper, Wyo., the study's primary investigator. He has no other relationship with Schering-Plough except that the company funded the study and a company employee (Dr. Waskin) was a coinvestigator.

Bacterial eradication rates were 86% for the garenoxacin group and 89% for the ceftriaxone group.

Schering-Plough hopes to win European approval for the drug for community-acquired pneumonia in 2007, but will be looking for a marketing partner to pursue approval of the drug in the United States, Dr. Waskin said.

The conference was sponsored by the American Society for Microbiology.

SAN FRANCISCO — An experimental fluoroquinolone compared favorably with amoxicillin or ceftriaxone for the treatment of community-acquired pneumonia in separate randomized, double-blind phase III trials, investigators reported in poster presentations at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

One study of 308 outpatients in Europe and Russia with mild to moderate community-acquired pneumonia showed similar response rates in patients given 5 days of oral garenoxacin or 10 days of oral amoxicillin, reported Dr. Hetty Waskin of Schering-Plough Research Institute, Kenilworth, N.J. The company is developing garenoxacin and funded the study. The lead investigator in the study was Dr. N. Mogulkoc of Ege University, Izmir, Turkey.

Evaluations that were conducted 7–14 days after completing therapy showed clinical responses in 91% of patients randomized to once-daily doses of 400 mg garenoxacin and in 87% of patients given amoxicillin 1 g t.i.d. The drugs eradicated pneumonia bacteria in 88% of the garenoxacin group and 91% of the amoxicillin group.

Drug-related adverse events—most commonly diarrhea, headache, abdominal pain, and nausea—were seen in 13% of patients in the garenoxacin group and 12% of those in the amoxicillin group.

The second study of 406 hospitalized patients with community-acquired pneumonia showed an 88% clinical cure rate in 328 evaluable patients regardless of treatment group. Patients were randomized to receive either IV garenoxacin 400 mg/day with possible step-down to oral garenoxacin 400 mg/day or IV ceftriaxone 1–2 g/day with possible step-down to oral clarithromycin 500 mg b.i.d. If clinicians suspected atypical pneumonia, patients in the ceftriaxone group also could receive IV erythromycin 0.5–1 g every 6 hours.

Patients were treated for 7–14 days and evaluated for cure 7–14 days after completing therapy, said Dr. Mark E. Dowell of Casper, Wyo., the study's primary investigator. He has no other relationship with Schering-Plough except that the company funded the study and a company employee (Dr. Waskin) was a coinvestigator.

Bacterial eradication rates were 86% for the garenoxacin group and 89% for the ceftriaxone group.

Schering-Plough hopes to win European approval for the drug for community-acquired pneumonia in 2007, but will be looking for a marketing partner to pursue approval of the drug in the United States, Dr. Waskin said.

The conference was sponsored by the American Society for Microbiology.