Old Chlamydia Variant Tied to New STD Outbreak

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NICE, FRANCE — An old nemesis appears to be the cause of a new outbreak of lymphogranuloma venereum proctitis.

The Chlamydia trachomatis L2b variant was thought to be a new strain when it was first identified as the major cause of the lymphogranuloma venereum (LGV) proctitis outbreak in homosexual men that began in the Netherlands in late 2003 and now occurs elsewhere in Europe, in Canada, and in the United States.

But recent findings suggest the C. trachomatis L2b variant was circulating among gay men in the 1980s in San Francisco and is appearing in large numbers as part of the overall increase in sexually transmitted diseases in this population, Julius Schachter, Ph.D., said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

“The obvious concern about LGV is that it's a systemic, more invasive disease that causes lots of tissue destruction and, because of the inflammatory component, was considered a potential risk factor for HIV transmission among gay men seen with the condition,” he said.

Chlamydiae were commonly recovered from rectal swabs from homosexual men with proctitis in San Francisco in the early 1980s. But the isolation rate dropped from about 33% to 6% in 1984–1985, suggesting that chlamydiae caused less proctitis as the gay community modified its behavior in response to AIDS, said Dr. Schachter, professor of laboratory medicine at the University of California, San Francisco. Throughout this time, about two-thirds of isolates were LGV.

After the recent outbreak began, serovar typing was performed on 51 archived specimens from San Francisco collected 20–25 years ago; 15 were identified as serovar L1, 18 as serovar L2, and 18 as the L2b variant (Emerg. Infect. Dis. 2005;11:1787–8).

New technologies, such as sequence-based nucleic acid testing, are useful in discriminating between LGV serovars and less invasive C. trachomatis species, he said.

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NICE, FRANCE — An old nemesis appears to be the cause of a new outbreak of lymphogranuloma venereum proctitis.

The Chlamydia trachomatis L2b variant was thought to be a new strain when it was first identified as the major cause of the lymphogranuloma venereum (LGV) proctitis outbreak in homosexual men that began in the Netherlands in late 2003 and now occurs elsewhere in Europe, in Canada, and in the United States.

But recent findings suggest the C. trachomatis L2b variant was circulating among gay men in the 1980s in San Francisco and is appearing in large numbers as part of the overall increase in sexually transmitted diseases in this population, Julius Schachter, Ph.D., said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

“The obvious concern about LGV is that it's a systemic, more invasive disease that causes lots of tissue destruction and, because of the inflammatory component, was considered a potential risk factor for HIV transmission among gay men seen with the condition,” he said.

Chlamydiae were commonly recovered from rectal swabs from homosexual men with proctitis in San Francisco in the early 1980s. But the isolation rate dropped from about 33% to 6% in 1984–1985, suggesting that chlamydiae caused less proctitis as the gay community modified its behavior in response to AIDS, said Dr. Schachter, professor of laboratory medicine at the University of California, San Francisco. Throughout this time, about two-thirds of isolates were LGV.

After the recent outbreak began, serovar typing was performed on 51 archived specimens from San Francisco collected 20–25 years ago; 15 were identified as serovar L1, 18 as serovar L2, and 18 as the L2b variant (Emerg. Infect. Dis. 2005;11:1787–8).

New technologies, such as sequence-based nucleic acid testing, are useful in discriminating between LGV serovars and less invasive C. trachomatis species, he said.

NICE, FRANCE — An old nemesis appears to be the cause of a new outbreak of lymphogranuloma venereum proctitis.

The Chlamydia trachomatis L2b variant was thought to be a new strain when it was first identified as the major cause of the lymphogranuloma venereum (LGV) proctitis outbreak in homosexual men that began in the Netherlands in late 2003 and now occurs elsewhere in Europe, in Canada, and in the United States.

But recent findings suggest the C. trachomatis L2b variant was circulating among gay men in the 1980s in San Francisco and is appearing in large numbers as part of the overall increase in sexually transmitted diseases in this population, Julius Schachter, Ph.D., said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

“The obvious concern about LGV is that it's a systemic, more invasive disease that causes lots of tissue destruction and, because of the inflammatory component, was considered a potential risk factor for HIV transmission among gay men seen with the condition,” he said.

Chlamydiae were commonly recovered from rectal swabs from homosexual men with proctitis in San Francisco in the early 1980s. But the isolation rate dropped from about 33% to 6% in 1984–1985, suggesting that chlamydiae caused less proctitis as the gay community modified its behavior in response to AIDS, said Dr. Schachter, professor of laboratory medicine at the University of California, San Francisco. Throughout this time, about two-thirds of isolates were LGV.

After the recent outbreak began, serovar typing was performed on 51 archived specimens from San Francisco collected 20–25 years ago; 15 were identified as serovar L1, 18 as serovar L2, and 18 as the L2b variant (Emerg. Infect. Dis. 2005;11:1787–8).

New technologies, such as sequence-based nucleic acid testing, are useful in discriminating between LGV serovars and less invasive C. trachomatis species, he said.

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Hospital's Infection Rate Defies Clean-Hands Effort

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NICE, FRANCE — A campaign to improve hand hygiene at a Danish hospital failed to decrease hospital-acquired infections, Dr. Sussie Laustsen and colleagues reported in a poster at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

The finding comes at a time when hand hygiene is being promoted as key to the World Health Organization's Global Patient Safety Challenge, which was launched in October 2005 to reduce health care-acquired infections worldwide.

In April 2004, a campaign began in all clinical departments at Aarhus (Denmark) University Hospital with instructions on performing alcohol-based hand disinfection.

Compliance with hand disinfection increased from 53% in the first quarter of 2004 to 71% in the first quarter of 2005, and consumption of hand alcohol doubled from about 1,250 L at baseline to 2,500 L in 2005.

However, the incidence of hospital-acquired infections did not decrease from baseline (1.77 per 1,000 bed-days) to the first quarter of 2005 (1.80 per 1,000 bed-days). The reason for this finding is unknown, but the hospital plans to increase surveillance, particularly among physicians, Dr. Laustsen said.

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NICE, FRANCE — A campaign to improve hand hygiene at a Danish hospital failed to decrease hospital-acquired infections, Dr. Sussie Laustsen and colleagues reported in a poster at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

The finding comes at a time when hand hygiene is being promoted as key to the World Health Organization's Global Patient Safety Challenge, which was launched in October 2005 to reduce health care-acquired infections worldwide.

In April 2004, a campaign began in all clinical departments at Aarhus (Denmark) University Hospital with instructions on performing alcohol-based hand disinfection.

Compliance with hand disinfection increased from 53% in the first quarter of 2004 to 71% in the first quarter of 2005, and consumption of hand alcohol doubled from about 1,250 L at baseline to 2,500 L in 2005.

However, the incidence of hospital-acquired infections did not decrease from baseline (1.77 per 1,000 bed-days) to the first quarter of 2005 (1.80 per 1,000 bed-days). The reason for this finding is unknown, but the hospital plans to increase surveillance, particularly among physicians, Dr. Laustsen said.

NICE, FRANCE — A campaign to improve hand hygiene at a Danish hospital failed to decrease hospital-acquired infections, Dr. Sussie Laustsen and colleagues reported in a poster at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

The finding comes at a time when hand hygiene is being promoted as key to the World Health Organization's Global Patient Safety Challenge, which was launched in October 2005 to reduce health care-acquired infections worldwide.

In April 2004, a campaign began in all clinical departments at Aarhus (Denmark) University Hospital with instructions on performing alcohol-based hand disinfection.

Compliance with hand disinfection increased from 53% in the first quarter of 2004 to 71% in the first quarter of 2005, and consumption of hand alcohol doubled from about 1,250 L at baseline to 2,500 L in 2005.

However, the incidence of hospital-acquired infections did not decrease from baseline (1.77 per 1,000 bed-days) to the first quarter of 2005 (1.80 per 1,000 bed-days). The reason for this finding is unknown, but the hospital plans to increase surveillance, particularly among physicians, Dr. Laustsen said.

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Global Survey: Age Is Big Factor In Antibiotic Noncompliance

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NICE, FRANCE — Although many people are concerned about antibiotic resistance, far fewer understand how their actions contribute to the problem, according to a global patient survey.

Results from the COMPLy (Compliance, Modalities by Population, Lifestyle and Geography) survey show that noncompliance is a global phenomenon that varies widely among countries, and is associated with patient age, dosage regimen, and patient attitudes toward their physicians.

A combination of telephone and in-person interviews were conducted in the fall of 2005 with 4,514 participants from 11 countries who were 18 years or older and had taken a self-administered antibiotic within the past 12 months. Noncompliance was defined as missing a dose or day, or having any medication left over.

A total of 4,088 patients were included in the study, which was sponsored by Pfizer Inc.

These were among the preliminary results presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases:

▸ Overall, 22% of respondents admitted to being noncompliant with their last antibiotic treatment. Noncompliance rates ranged from a low of 10% in the Netherlands to a high of 44% in China.

▸ Of those surveyed, 8 out of 10 reported that antibiotic-resistant germs are a very serious problem, but only 6 in 10 believed that taking an antibiotic improperly might reduce its effectiveness the next time it is used.

▸ Half of respondents believed leftover antibiotics could be saved and used again.

▸ Among those with leftover antibiotics, 74% said they saved them, 18% threw them away, 5% gave them to someone else, and 3% dealt with them by other means.

▸ Noncompliance among patients aged 18–29 years was twice as high (30%), compared with those 60 years and older (14%).

▸ Noncompliance was lower among patients taking one dose per day (15%), compared with those taking two doses per day (21%) or three or more doses daily (27%).

A patient's attitude toward his or her physician is another factor driving noncompliance, said Dr. Jean-Claude Pechère, who presented the results at the meeting. Patients who feel actively involved in decisions about the management of their condition are more likely to comply with an antibiotic regimen, compared with those who are critical of their physician's abilities or feel ignored.

Attitudes differ by country. For example, Americans tend to be more involved patients, whereas many Japanese patients feel ignored, said Dr. Pechère, COMPLy steering committee chair and professor emeritus, University of Geneva. Noncompliance was 19% in the United States, compared with 34% in Japan, the study said.

ELSEVIER GLOBAL MEDICAL NEWS

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NICE, FRANCE — Although many people are concerned about antibiotic resistance, far fewer understand how their actions contribute to the problem, according to a global patient survey.

Results from the COMPLy (Compliance, Modalities by Population, Lifestyle and Geography) survey show that noncompliance is a global phenomenon that varies widely among countries, and is associated with patient age, dosage regimen, and patient attitudes toward their physicians.

A combination of telephone and in-person interviews were conducted in the fall of 2005 with 4,514 participants from 11 countries who were 18 years or older and had taken a self-administered antibiotic within the past 12 months. Noncompliance was defined as missing a dose or day, or having any medication left over.

A total of 4,088 patients were included in the study, which was sponsored by Pfizer Inc.

These were among the preliminary results presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases:

▸ Overall, 22% of respondents admitted to being noncompliant with their last antibiotic treatment. Noncompliance rates ranged from a low of 10% in the Netherlands to a high of 44% in China.

▸ Of those surveyed, 8 out of 10 reported that antibiotic-resistant germs are a very serious problem, but only 6 in 10 believed that taking an antibiotic improperly might reduce its effectiveness the next time it is used.

▸ Half of respondents believed leftover antibiotics could be saved and used again.

▸ Among those with leftover antibiotics, 74% said they saved them, 18% threw them away, 5% gave them to someone else, and 3% dealt with them by other means.

▸ Noncompliance among patients aged 18–29 years was twice as high (30%), compared with those 60 years and older (14%).

▸ Noncompliance was lower among patients taking one dose per day (15%), compared with those taking two doses per day (21%) or three or more doses daily (27%).

A patient's attitude toward his or her physician is another factor driving noncompliance, said Dr. Jean-Claude Pechère, who presented the results at the meeting. Patients who feel actively involved in decisions about the management of their condition are more likely to comply with an antibiotic regimen, compared with those who are critical of their physician's abilities or feel ignored.

Attitudes differ by country. For example, Americans tend to be more involved patients, whereas many Japanese patients feel ignored, said Dr. Pechère, COMPLy steering committee chair and professor emeritus, University of Geneva. Noncompliance was 19% in the United States, compared with 34% in Japan, the study said.

ELSEVIER GLOBAL MEDICAL NEWS

NICE, FRANCE — Although many people are concerned about antibiotic resistance, far fewer understand how their actions contribute to the problem, according to a global patient survey.

Results from the COMPLy (Compliance, Modalities by Population, Lifestyle and Geography) survey show that noncompliance is a global phenomenon that varies widely among countries, and is associated with patient age, dosage regimen, and patient attitudes toward their physicians.

A combination of telephone and in-person interviews were conducted in the fall of 2005 with 4,514 participants from 11 countries who were 18 years or older and had taken a self-administered antibiotic within the past 12 months. Noncompliance was defined as missing a dose or day, or having any medication left over.

A total of 4,088 patients were included in the study, which was sponsored by Pfizer Inc.

These were among the preliminary results presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases:

▸ Overall, 22% of respondents admitted to being noncompliant with their last antibiotic treatment. Noncompliance rates ranged from a low of 10% in the Netherlands to a high of 44% in China.

▸ Of those surveyed, 8 out of 10 reported that antibiotic-resistant germs are a very serious problem, but only 6 in 10 believed that taking an antibiotic improperly might reduce its effectiveness the next time it is used.

▸ Half of respondents believed leftover antibiotics could be saved and used again.

▸ Among those with leftover antibiotics, 74% said they saved them, 18% threw them away, 5% gave them to someone else, and 3% dealt with them by other means.

▸ Noncompliance among patients aged 18–29 years was twice as high (30%), compared with those 60 years and older (14%).

▸ Noncompliance was lower among patients taking one dose per day (15%), compared with those taking two doses per day (21%) or three or more doses daily (27%).

A patient's attitude toward his or her physician is another factor driving noncompliance, said Dr. Jean-Claude Pechère, who presented the results at the meeting. Patients who feel actively involved in decisions about the management of their condition are more likely to comply with an antibiotic regimen, compared with those who are critical of their physician's abilities or feel ignored.

Attitudes differ by country. For example, Americans tend to be more involved patients, whereas many Japanese patients feel ignored, said Dr. Pechère, COMPLy steering committee chair and professor emeritus, University of Geneva. Noncompliance was 19% in the United States, compared with 34% in Japan, the study said.

ELSEVIER GLOBAL MEDICAL NEWS

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Three-Year Testosterone Regimen Didn't Improve Cognition in Healthy Older Men

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CHICAGO — Exogenous testosterone, taken either alone or with finasteride for 36 months, did not significantly improve cognition in a randomized, placebo-controlled trial involving healthy older men.

The findings do little to settle the debate over the effect of hormone therapy on cognition in elderly men. About half of randomized, controlled trials of testosterone therapy in older men have shown positive effects on cognitive function, particularly spatial cognition, Dr. Camille Vaughan said at the annual meeting of the American Geriatrics Society.

She presented data from a study in which 70 healthy men, ages 65–83 years, with low levels of testosterone (less than 350 ng/dL) and normal performance on the Mini-Mental State Examination (MMSE) were randomly assigned to receive one of three regimens: 200 mg of IM testosterone enanthate every 2 weeks with placebo pills; 200 mg of IM testosterone enanthate every 2 weeks with 5 mg of finasteride daily; or placebo injections and placebo pills.

At baseline, there were no significant differences in hormone levels between groups. Their mean age was 72 years. All patients had an MMSE score of 28 or higher, out of 30, reported Dr. Vaughan, an internal medicine resident at Emory University in Atlanta, and colleagues.

Cognitive testing performed at baseline, 4 months, and 36 months included a comprehensive battery assessing attention, executive function, visuospatial skills, and visual and verbal memory skills. Serum hormone levels also were measured at the indicated intervals.

Sixty-nine men completed baseline testing, 65 completed at least 4 months, and 46 completed all 36 months of the study.

Serum total testosterone, bioavailable testosterone, and estradiol levels increased significantly in the treatment groups throughout the study period. Hormone levels did not change for the placebo group at any time.

The three groups didn't demonstrate significant differences in cognitive performance on any of the tests at the 4- or 36-month evaluations, Dr. Vaughan said. There was a trend in the active treatment groups toward improved performance in the Benton Visual Retention Test and in visuospatial skills on the Visual Patterns Test. But scores were not significantly different from the placebo group at any time.

Further studies are warranted to determine if hormone therapy in men with preexisting cognitive impairment is beneficial, Dr. Vaughan concluded.

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CHICAGO — Exogenous testosterone, taken either alone or with finasteride for 36 months, did not significantly improve cognition in a randomized, placebo-controlled trial involving healthy older men.

The findings do little to settle the debate over the effect of hormone therapy on cognition in elderly men. About half of randomized, controlled trials of testosterone therapy in older men have shown positive effects on cognitive function, particularly spatial cognition, Dr. Camille Vaughan said at the annual meeting of the American Geriatrics Society.

She presented data from a study in which 70 healthy men, ages 65–83 years, with low levels of testosterone (less than 350 ng/dL) and normal performance on the Mini-Mental State Examination (MMSE) were randomly assigned to receive one of three regimens: 200 mg of IM testosterone enanthate every 2 weeks with placebo pills; 200 mg of IM testosterone enanthate every 2 weeks with 5 mg of finasteride daily; or placebo injections and placebo pills.

At baseline, there were no significant differences in hormone levels between groups. Their mean age was 72 years. All patients had an MMSE score of 28 or higher, out of 30, reported Dr. Vaughan, an internal medicine resident at Emory University in Atlanta, and colleagues.

Cognitive testing performed at baseline, 4 months, and 36 months included a comprehensive battery assessing attention, executive function, visuospatial skills, and visual and verbal memory skills. Serum hormone levels also were measured at the indicated intervals.

Sixty-nine men completed baseline testing, 65 completed at least 4 months, and 46 completed all 36 months of the study.

Serum total testosterone, bioavailable testosterone, and estradiol levels increased significantly in the treatment groups throughout the study period. Hormone levels did not change for the placebo group at any time.

The three groups didn't demonstrate significant differences in cognitive performance on any of the tests at the 4- or 36-month evaluations, Dr. Vaughan said. There was a trend in the active treatment groups toward improved performance in the Benton Visual Retention Test and in visuospatial skills on the Visual Patterns Test. But scores were not significantly different from the placebo group at any time.

Further studies are warranted to determine if hormone therapy in men with preexisting cognitive impairment is beneficial, Dr. Vaughan concluded.

CHICAGO — Exogenous testosterone, taken either alone or with finasteride for 36 months, did not significantly improve cognition in a randomized, placebo-controlled trial involving healthy older men.

The findings do little to settle the debate over the effect of hormone therapy on cognition in elderly men. About half of randomized, controlled trials of testosterone therapy in older men have shown positive effects on cognitive function, particularly spatial cognition, Dr. Camille Vaughan said at the annual meeting of the American Geriatrics Society.

She presented data from a study in which 70 healthy men, ages 65–83 years, with low levels of testosterone (less than 350 ng/dL) and normal performance on the Mini-Mental State Examination (MMSE) were randomly assigned to receive one of three regimens: 200 mg of IM testosterone enanthate every 2 weeks with placebo pills; 200 mg of IM testosterone enanthate every 2 weeks with 5 mg of finasteride daily; or placebo injections and placebo pills.

At baseline, there were no significant differences in hormone levels between groups. Their mean age was 72 years. All patients had an MMSE score of 28 or higher, out of 30, reported Dr. Vaughan, an internal medicine resident at Emory University in Atlanta, and colleagues.

Cognitive testing performed at baseline, 4 months, and 36 months included a comprehensive battery assessing attention, executive function, visuospatial skills, and visual and verbal memory skills. Serum hormone levels also were measured at the indicated intervals.

Sixty-nine men completed baseline testing, 65 completed at least 4 months, and 46 completed all 36 months of the study.

Serum total testosterone, bioavailable testosterone, and estradiol levels increased significantly in the treatment groups throughout the study period. Hormone levels did not change for the placebo group at any time.

The three groups didn't demonstrate significant differences in cognitive performance on any of the tests at the 4- or 36-month evaluations, Dr. Vaughan said. There was a trend in the active treatment groups toward improved performance in the Benton Visual Retention Test and in visuospatial skills on the Visual Patterns Test. But scores were not significantly different from the placebo group at any time.

Further studies are warranted to determine if hormone therapy in men with preexisting cognitive impairment is beneficial, Dr. Vaughan concluded.

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Unnecessary PSA Screening Of Elderly Men Occurs Often

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CHICAGO — Despite recommendations to the contrary, prostate-specific antigen screening is being performed in many elderly men who are not in good health and have limited life expectancies.

That conclusion was drawn from an analysis of data collected during a cohort study of 597,824 veterans aged 70 years and older who were seen at 104 Veterans Health Administration centers during fiscal years 2002 and 2003. The subjects did not have a history of prostate cancer, elevated prostate-specific antigen (PSA) levels, or prostate symptoms.

Most guidelines recommend that PSA screening should not be performed in elderly men who have a life expectancy of fewer than 10 years—the majority of those over age 80 years and men aged 70 years or older in poor health—because the known harms outweigh the potential benefits, Dr. Louise Walter and associates reported at the annual meeting of the American Geriatrics Society.

PSA levels are often inaccurate, leading to unnecessary biopsies because of false-positive results. This can cause psychological distress as well as treatment of irrelevant cancers, which may lead to incontinence or impotence. “The benefit of PSA screening remains unproven, and even if some benefit is ultimately proven, it is estimated that a life expectancy of 10–20 years would be needed for any chance of receiving such a survival benefit,” said Dr. Walter, of the geriatrics division at the University of California, San Francisco, and a staff physician at San Francisco VA Medical Center.

The mean age of the men in the VA-supported study was 77 years, and 333,041 (56%) had a PSA test performed in 2003. Health status was measured with the Charlson-Deyo index using VA and Medicare claims in 2002. The scores were used to stratify the men into three groups, ranging from best health (score of 0) to worst health (score of 4 or more).

PSA screening rates decreased significantly with advancing age, ranging from 64% in men aged 70–74 years to 27% in men aged 90 or older. But screening rates did not decline substantially with worsening health, she said. Among men aged 85–89 years, 36% in the best-health group had a PSA test, compared with 37% in the worst-health group.

Although men aged 80 years or older in the worst health have less than a 10% chance of living 10 years, 11,391 (41%) of these men had a PSA test.

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CHICAGO — Despite recommendations to the contrary, prostate-specific antigen screening is being performed in many elderly men who are not in good health and have limited life expectancies.

That conclusion was drawn from an analysis of data collected during a cohort study of 597,824 veterans aged 70 years and older who were seen at 104 Veterans Health Administration centers during fiscal years 2002 and 2003. The subjects did not have a history of prostate cancer, elevated prostate-specific antigen (PSA) levels, or prostate symptoms.

Most guidelines recommend that PSA screening should not be performed in elderly men who have a life expectancy of fewer than 10 years—the majority of those over age 80 years and men aged 70 years or older in poor health—because the known harms outweigh the potential benefits, Dr. Louise Walter and associates reported at the annual meeting of the American Geriatrics Society.

PSA levels are often inaccurate, leading to unnecessary biopsies because of false-positive results. This can cause psychological distress as well as treatment of irrelevant cancers, which may lead to incontinence or impotence. “The benefit of PSA screening remains unproven, and even if some benefit is ultimately proven, it is estimated that a life expectancy of 10–20 years would be needed for any chance of receiving such a survival benefit,” said Dr. Walter, of the geriatrics division at the University of California, San Francisco, and a staff physician at San Francisco VA Medical Center.

The mean age of the men in the VA-supported study was 77 years, and 333,041 (56%) had a PSA test performed in 2003. Health status was measured with the Charlson-Deyo index using VA and Medicare claims in 2002. The scores were used to stratify the men into three groups, ranging from best health (score of 0) to worst health (score of 4 or more).

PSA screening rates decreased significantly with advancing age, ranging from 64% in men aged 70–74 years to 27% in men aged 90 or older. But screening rates did not decline substantially with worsening health, she said. Among men aged 85–89 years, 36% in the best-health group had a PSA test, compared with 37% in the worst-health group.

Although men aged 80 years or older in the worst health have less than a 10% chance of living 10 years, 11,391 (41%) of these men had a PSA test.

CHICAGO — Despite recommendations to the contrary, prostate-specific antigen screening is being performed in many elderly men who are not in good health and have limited life expectancies.

That conclusion was drawn from an analysis of data collected during a cohort study of 597,824 veterans aged 70 years and older who were seen at 104 Veterans Health Administration centers during fiscal years 2002 and 2003. The subjects did not have a history of prostate cancer, elevated prostate-specific antigen (PSA) levels, or prostate symptoms.

Most guidelines recommend that PSA screening should not be performed in elderly men who have a life expectancy of fewer than 10 years—the majority of those over age 80 years and men aged 70 years or older in poor health—because the known harms outweigh the potential benefits, Dr. Louise Walter and associates reported at the annual meeting of the American Geriatrics Society.

PSA levels are often inaccurate, leading to unnecessary biopsies because of false-positive results. This can cause psychological distress as well as treatment of irrelevant cancers, which may lead to incontinence or impotence. “The benefit of PSA screening remains unproven, and even if some benefit is ultimately proven, it is estimated that a life expectancy of 10–20 years would be needed for any chance of receiving such a survival benefit,” said Dr. Walter, of the geriatrics division at the University of California, San Francisco, and a staff physician at San Francisco VA Medical Center.

The mean age of the men in the VA-supported study was 77 years, and 333,041 (56%) had a PSA test performed in 2003. Health status was measured with the Charlson-Deyo index using VA and Medicare claims in 2002. The scores were used to stratify the men into three groups, ranging from best health (score of 0) to worst health (score of 4 or more).

PSA screening rates decreased significantly with advancing age, ranging from 64% in men aged 70–74 years to 27% in men aged 90 or older. But screening rates did not decline substantially with worsening health, she said. Among men aged 85–89 years, 36% in the best-health group had a PSA test, compared with 37% in the worst-health group.

Although men aged 80 years or older in the worst health have less than a 10% chance of living 10 years, 11,391 (41%) of these men had a PSA test.

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Ritalin Lifted Dementia-Related Apathy in a 13-Patient Study

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CHICAGO — Methylphenidate may be effective in the treatment of apathy associated with dementia of the Alzheimer type, Dr. Prasad Padala and associates reported in a poster at the annual meeting of the American Geriatrics Society.

Results from an open-label study in 13 patients suggest that methylphenidate (Ritalin) has a substantial effect on apathy, with smaller but significant positive effects on mood, cognition, and independent activities of daily living.

The findings warrant further testing with a double-blind, placebo-controlled trial, he noted.

Apathy is the most common behavior problem reported in persons with Alzheimer's disease, affecting about 70%–90% of patients.

All patients in the study had dementia of the Alzheimer type, Mini-Mental State Examination (MMSE) scores greater than 18, and Apathy Evaluation Scale (AES) scores greater than 30. Their mean age was 69 years.

All patients were started on methylphenidate 5 mg twice daily; the dose was titrated to 10 mg twice daily over a 2-week period. Follow-up visits were scheduled at 4, 8, and 12 weeks.

Significant improvement in apathy (AES 52.6 vs. 31.6) was reported from baseline over 12 weeks, reported Dr. Padala, of the department of psychiatry at the University of Nebraska, Omaha, and a psychiatrist at the Omaha division of the VA (Veterans Affairs) Nebraska Western Iowa Health Care System.

Less robust but significant improvement was noted at 12 weeks in Geriatric Depression Scale scores (93 vs. 63), MMSE scores (24.2 vs. 25.5) and Independent Activities of Daily Living criteria (13.7 vs. 16).

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CHICAGO — Methylphenidate may be effective in the treatment of apathy associated with dementia of the Alzheimer type, Dr. Prasad Padala and associates reported in a poster at the annual meeting of the American Geriatrics Society.

Results from an open-label study in 13 patients suggest that methylphenidate (Ritalin) has a substantial effect on apathy, with smaller but significant positive effects on mood, cognition, and independent activities of daily living.

The findings warrant further testing with a double-blind, placebo-controlled trial, he noted.

Apathy is the most common behavior problem reported in persons with Alzheimer's disease, affecting about 70%–90% of patients.

All patients in the study had dementia of the Alzheimer type, Mini-Mental State Examination (MMSE) scores greater than 18, and Apathy Evaluation Scale (AES) scores greater than 30. Their mean age was 69 years.

All patients were started on methylphenidate 5 mg twice daily; the dose was titrated to 10 mg twice daily over a 2-week period. Follow-up visits were scheduled at 4, 8, and 12 weeks.

Significant improvement in apathy (AES 52.6 vs. 31.6) was reported from baseline over 12 weeks, reported Dr. Padala, of the department of psychiatry at the University of Nebraska, Omaha, and a psychiatrist at the Omaha division of the VA (Veterans Affairs) Nebraska Western Iowa Health Care System.

Less robust but significant improvement was noted at 12 weeks in Geriatric Depression Scale scores (93 vs. 63), MMSE scores (24.2 vs. 25.5) and Independent Activities of Daily Living criteria (13.7 vs. 16).

CHICAGO — Methylphenidate may be effective in the treatment of apathy associated with dementia of the Alzheimer type, Dr. Prasad Padala and associates reported in a poster at the annual meeting of the American Geriatrics Society.

Results from an open-label study in 13 patients suggest that methylphenidate (Ritalin) has a substantial effect on apathy, with smaller but significant positive effects on mood, cognition, and independent activities of daily living.

The findings warrant further testing with a double-blind, placebo-controlled trial, he noted.

Apathy is the most common behavior problem reported in persons with Alzheimer's disease, affecting about 70%–90% of patients.

All patients in the study had dementia of the Alzheimer type, Mini-Mental State Examination (MMSE) scores greater than 18, and Apathy Evaluation Scale (AES) scores greater than 30. Their mean age was 69 years.

All patients were started on methylphenidate 5 mg twice daily; the dose was titrated to 10 mg twice daily over a 2-week period. Follow-up visits were scheduled at 4, 8, and 12 weeks.

Significant improvement in apathy (AES 52.6 vs. 31.6) was reported from baseline over 12 weeks, reported Dr. Padala, of the department of psychiatry at the University of Nebraska, Omaha, and a psychiatrist at the Omaha division of the VA (Veterans Affairs) Nebraska Western Iowa Health Care System.

Less robust but significant improvement was noted at 12 weeks in Geriatric Depression Scale scores (93 vs. 63), MMSE scores (24.2 vs. 25.5) and Independent Activities of Daily Living criteria (13.7 vs. 16).

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Severe Alzheimer's Responds to Donepezil

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CHICAGO — Patients with severe Alzheimer's disease showed improved cognition and function when treated with donepezil in a 24-week, placebo-controlled trial, Dr. Sandra Black and her associates reported in a poster at the annual meeting of the American Geriatrics Society.

The results are consistent with a Swedish nursing home study in a similarly institutionalized population (Lancet 2006;367:1262–70), suggesting that even patients with severe disease can benefit from treatment with donepezil.

“The two studies taken together suggest that this stage of disease can show measurable benefits of treatment with donepezil,” Dr. Black, professor of medicine and head of neurology at Sunnybrook Health Sciences Centre, University of Toronto, said in an interview.

Donepezil (Aricept) is approved for mild to moderate Alzheimer's disease. In February 2006, the U.S. Food and Drug Administration accepted a supplemental new drug application for donepezil in severe Alzheimer's disease.

Doses of 5 mg and 10 mg of donepezil are typically administered once daily.

Dr. Black and her colleagues study randomized 343 patients with severe Alzheimer's disease to an initial dose of donepezil 5 mg/day for 6 weeks and then 10 mg/day donepezil (176 patients) or placebo (167 patients) for 24 weeks. Patients resided in the community or in assisted-living facilities. Baseline characteristics were similar in both groups. Overall, 117 of the 176 donepezil-treated patients and 127 of the 167 placebo patients completed the study, which was supported by Eisai Inc. and Pfizer Inc. Dr. Black holds no financial interest in either firm, but has been a study investigator for both. She is an ad hoc consultant and speaker, and has received honoraria from Pfizer.

Primary end points were change from baseline in Severe Impairment Battery (SIB) total score and Clinician's Interview-Based Impression of Change-Plus (CIBIC-plus) at 24 weeks.

The primary analysis was based on the intent-to-treat population using a last-observation-carried- forward analysis at 24 weeks. Categories in the CIBIC-plus analysis were collapsed (1–3 equals improved; 4 equals no change; and 5–7 equals worsened) because the distribution of values was sparse in categories 1, 2, and 7.

Donepezil was significantly superior to placebo on the SIB score at week 24 in the intent-to-treat population (mean difference 5.3), and at weeks 8, 16, and 24 in patients who completed the study. Most reported adverse events were mild to moderate (74%), the most common of which were diarrhea, nausea, and insomnia.

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CHICAGO — Patients with severe Alzheimer's disease showed improved cognition and function when treated with donepezil in a 24-week, placebo-controlled trial, Dr. Sandra Black and her associates reported in a poster at the annual meeting of the American Geriatrics Society.

The results are consistent with a Swedish nursing home study in a similarly institutionalized population (Lancet 2006;367:1262–70), suggesting that even patients with severe disease can benefit from treatment with donepezil.

“The two studies taken together suggest that this stage of disease can show measurable benefits of treatment with donepezil,” Dr. Black, professor of medicine and head of neurology at Sunnybrook Health Sciences Centre, University of Toronto, said in an interview.

Donepezil (Aricept) is approved for mild to moderate Alzheimer's disease. In February 2006, the U.S. Food and Drug Administration accepted a supplemental new drug application for donepezil in severe Alzheimer's disease.

Doses of 5 mg and 10 mg of donepezil are typically administered once daily.

Dr. Black and her colleagues study randomized 343 patients with severe Alzheimer's disease to an initial dose of donepezil 5 mg/day for 6 weeks and then 10 mg/day donepezil (176 patients) or placebo (167 patients) for 24 weeks. Patients resided in the community or in assisted-living facilities. Baseline characteristics were similar in both groups. Overall, 117 of the 176 donepezil-treated patients and 127 of the 167 placebo patients completed the study, which was supported by Eisai Inc. and Pfizer Inc. Dr. Black holds no financial interest in either firm, but has been a study investigator for both. She is an ad hoc consultant and speaker, and has received honoraria from Pfizer.

Primary end points were change from baseline in Severe Impairment Battery (SIB) total score and Clinician's Interview-Based Impression of Change-Plus (CIBIC-plus) at 24 weeks.

The primary analysis was based on the intent-to-treat population using a last-observation-carried- forward analysis at 24 weeks. Categories in the CIBIC-plus analysis were collapsed (1–3 equals improved; 4 equals no change; and 5–7 equals worsened) because the distribution of values was sparse in categories 1, 2, and 7.

Donepezil was significantly superior to placebo on the SIB score at week 24 in the intent-to-treat population (mean difference 5.3), and at weeks 8, 16, and 24 in patients who completed the study. Most reported adverse events were mild to moderate (74%), the most common of which were diarrhea, nausea, and insomnia.

CHICAGO — Patients with severe Alzheimer's disease showed improved cognition and function when treated with donepezil in a 24-week, placebo-controlled trial, Dr. Sandra Black and her associates reported in a poster at the annual meeting of the American Geriatrics Society.

The results are consistent with a Swedish nursing home study in a similarly institutionalized population (Lancet 2006;367:1262–70), suggesting that even patients with severe disease can benefit from treatment with donepezil.

“The two studies taken together suggest that this stage of disease can show measurable benefits of treatment with donepezil,” Dr. Black, professor of medicine and head of neurology at Sunnybrook Health Sciences Centre, University of Toronto, said in an interview.

Donepezil (Aricept) is approved for mild to moderate Alzheimer's disease. In February 2006, the U.S. Food and Drug Administration accepted a supplemental new drug application for donepezil in severe Alzheimer's disease.

Doses of 5 mg and 10 mg of donepezil are typically administered once daily.

Dr. Black and her colleagues study randomized 343 patients with severe Alzheimer's disease to an initial dose of donepezil 5 mg/day for 6 weeks and then 10 mg/day donepezil (176 patients) or placebo (167 patients) for 24 weeks. Patients resided in the community or in assisted-living facilities. Baseline characteristics were similar in both groups. Overall, 117 of the 176 donepezil-treated patients and 127 of the 167 placebo patients completed the study, which was supported by Eisai Inc. and Pfizer Inc. Dr. Black holds no financial interest in either firm, but has been a study investigator for both. She is an ad hoc consultant and speaker, and has received honoraria from Pfizer.

Primary end points were change from baseline in Severe Impairment Battery (SIB) total score and Clinician's Interview-Based Impression of Change-Plus (CIBIC-plus) at 24 weeks.

The primary analysis was based on the intent-to-treat population using a last-observation-carried- forward analysis at 24 weeks. Categories in the CIBIC-plus analysis were collapsed (1–3 equals improved; 4 equals no change; and 5–7 equals worsened) because the distribution of values was sparse in categories 1, 2, and 7.

Donepezil was significantly superior to placebo on the SIB score at week 24 in the intent-to-treat population (mean difference 5.3), and at weeks 8, 16, and 24 in patients who completed the study. Most reported adverse events were mild to moderate (74%), the most common of which were diarrhea, nausea, and insomnia.

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Rifabutin-Based Therapy Tackles H. pylori

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NICE, FRANCE — Two different rifabutin-based, triple-therapy approaches proved to be safe and effective rescue therapies in two European trials involving patients with treatment-resistant Helicobacter pylori.

In primary care, first-line triple therapy has been shown to fail in up to 27% of patients. These failures are frequently due to metronidazole or clarithromycin resistance. Further, up to 75% of these infections are resistant to both drugs, Dr. Stephan Miehlke said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

Triple therapy with a proton pump inhibitor, rifabutin, and either amoxicillin or levofloxacin has been proven effective as salvage therapy. More recently, some physicians have undertaken first-line therapy with a proton pump inhibitor, moxifloxacin, and either clarithromycin or amoxicillin.

To assess this type of therapy, Dr. Miehlke and his associates treated 104 consecutive patients with H. pylori infections who were resistant to both metronidazole and clarithromycin by giving them esomeprazole 40 mg, moxifloxacin 400 mg, and rifabutin 300 mg orally once each morning for 7 days.

Indications for treatment included peptic ulcers (30%), functional dyspepsia/nonulcer dyspepsia (59%), and other diagnoses (11%). Two-thirds of the patients had a history of two or more previous treatment failures, and 25% had a known history of penicillin intolerance.

Follow-up endoscopy, including histology and H. pylori culture, was performed 6–8 weeks after treatment. Clinical failure was defined as at least one positive biopsy-based test or a positive urea breath test.

Four patients discontinued treatment prematurely because of adverse events, and two were lost to follow-up. Successful eradication of H. pylori infection was confirmed in 70 of the 86 patients (81%) for whom follow-up endoscopy was available.

In the 16 patients who were deemed treatment failures, posttreatment resistance to rifampicin was detected in 5 patients, and resistance to ciprofloxacin in 3. Minor adverse events occurred in 57% of patients and commonly included nausea, headache, and muscle pain.

Although secondary resistance can occur, the 1-week, once-daily therapy is safe, is at least as effective as quadruple therapy, and may be particularly useful for patients with an intolerance to penicillin, concluded Dr. Miehlke of the Technical University Hospital in Dresden, Germany.

Results from a second study he presented demonstrated that rifabutin-based triple therapy was comparable to high-dose dual therapy for treatment-resistant H. pylori, and that sequential therapy is both possible and effective.

In that study, 145 patients with H. pylori infection who were resistant to both metronidazole and clarithromycin were prospectively randomized to receive one of two regimens: either twice-daily therapy for 7 days with esomeprazole 20 mg, rifabutin 150 mg, and amoxicillin 1,000 mg; or thrice-daily therapy for 14 days with omeprazole 40 mg and amoxicillin 1,000 mg.

Indications for treatment included peptic ulcer disease (37%), nonulcer dyspepsia (46.6%), gastroesophageal reflux disease (2.7%), and other diagnoses (13.7%). Two-thirds of the patients (68%) had failed two or more previous treatment regimens.

Six patients discontinued treatment prematurely due to side effects, and three were lost to follow-up.

Eradication of H. pylori infection was achieved in 78% of triple-therapy patients (54/69) and 75% of high-dose, dual-therapy patients (50/67), according to the per protocol analysis. By the intent-to-treat analysis, the figures were 74% vs. 70%. The difference between the two groups was not statistically significant, Dr. Miehlke said.

Seven of 10 patients who failed high-dose dual therapy were cured by crossover to triple therapy.

Eight of 10 patients who failed triple therapy were cured by crossover to high-dose dual therapy.

Posttreatment resistance to amoxicillin or rifabutin was not detected. There were more adverse events reported by patients who were given triple therapy (35%) than by those who received dual therapy (20%). The most common events reported were nausea, diarrhea, headache, and erythema.

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NICE, FRANCE — Two different rifabutin-based, triple-therapy approaches proved to be safe and effective rescue therapies in two European trials involving patients with treatment-resistant Helicobacter pylori.

In primary care, first-line triple therapy has been shown to fail in up to 27% of patients. These failures are frequently due to metronidazole or clarithromycin resistance. Further, up to 75% of these infections are resistant to both drugs, Dr. Stephan Miehlke said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

Triple therapy with a proton pump inhibitor, rifabutin, and either amoxicillin or levofloxacin has been proven effective as salvage therapy. More recently, some physicians have undertaken first-line therapy with a proton pump inhibitor, moxifloxacin, and either clarithromycin or amoxicillin.

To assess this type of therapy, Dr. Miehlke and his associates treated 104 consecutive patients with H. pylori infections who were resistant to both metronidazole and clarithromycin by giving them esomeprazole 40 mg, moxifloxacin 400 mg, and rifabutin 300 mg orally once each morning for 7 days.

Indications for treatment included peptic ulcers (30%), functional dyspepsia/nonulcer dyspepsia (59%), and other diagnoses (11%). Two-thirds of the patients had a history of two or more previous treatment failures, and 25% had a known history of penicillin intolerance.

Follow-up endoscopy, including histology and H. pylori culture, was performed 6–8 weeks after treatment. Clinical failure was defined as at least one positive biopsy-based test or a positive urea breath test.

Four patients discontinued treatment prematurely because of adverse events, and two were lost to follow-up. Successful eradication of H. pylori infection was confirmed in 70 of the 86 patients (81%) for whom follow-up endoscopy was available.

In the 16 patients who were deemed treatment failures, posttreatment resistance to rifampicin was detected in 5 patients, and resistance to ciprofloxacin in 3. Minor adverse events occurred in 57% of patients and commonly included nausea, headache, and muscle pain.

Although secondary resistance can occur, the 1-week, once-daily therapy is safe, is at least as effective as quadruple therapy, and may be particularly useful for patients with an intolerance to penicillin, concluded Dr. Miehlke of the Technical University Hospital in Dresden, Germany.

Results from a second study he presented demonstrated that rifabutin-based triple therapy was comparable to high-dose dual therapy for treatment-resistant H. pylori, and that sequential therapy is both possible and effective.

In that study, 145 patients with H. pylori infection who were resistant to both metronidazole and clarithromycin were prospectively randomized to receive one of two regimens: either twice-daily therapy for 7 days with esomeprazole 20 mg, rifabutin 150 mg, and amoxicillin 1,000 mg; or thrice-daily therapy for 14 days with omeprazole 40 mg and amoxicillin 1,000 mg.

Indications for treatment included peptic ulcer disease (37%), nonulcer dyspepsia (46.6%), gastroesophageal reflux disease (2.7%), and other diagnoses (13.7%). Two-thirds of the patients (68%) had failed two or more previous treatment regimens.

Six patients discontinued treatment prematurely due to side effects, and three were lost to follow-up.

Eradication of H. pylori infection was achieved in 78% of triple-therapy patients (54/69) and 75% of high-dose, dual-therapy patients (50/67), according to the per protocol analysis. By the intent-to-treat analysis, the figures were 74% vs. 70%. The difference between the two groups was not statistically significant, Dr. Miehlke said.

Seven of 10 patients who failed high-dose dual therapy were cured by crossover to triple therapy.

Eight of 10 patients who failed triple therapy were cured by crossover to high-dose dual therapy.

Posttreatment resistance to amoxicillin or rifabutin was not detected. There were more adverse events reported by patients who were given triple therapy (35%) than by those who received dual therapy (20%). The most common events reported were nausea, diarrhea, headache, and erythema.

NICE, FRANCE — Two different rifabutin-based, triple-therapy approaches proved to be safe and effective rescue therapies in two European trials involving patients with treatment-resistant Helicobacter pylori.

In primary care, first-line triple therapy has been shown to fail in up to 27% of patients. These failures are frequently due to metronidazole or clarithromycin resistance. Further, up to 75% of these infections are resistant to both drugs, Dr. Stephan Miehlke said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

Triple therapy with a proton pump inhibitor, rifabutin, and either amoxicillin or levofloxacin has been proven effective as salvage therapy. More recently, some physicians have undertaken first-line therapy with a proton pump inhibitor, moxifloxacin, and either clarithromycin or amoxicillin.

To assess this type of therapy, Dr. Miehlke and his associates treated 104 consecutive patients with H. pylori infections who were resistant to both metronidazole and clarithromycin by giving them esomeprazole 40 mg, moxifloxacin 400 mg, and rifabutin 300 mg orally once each morning for 7 days.

Indications for treatment included peptic ulcers (30%), functional dyspepsia/nonulcer dyspepsia (59%), and other diagnoses (11%). Two-thirds of the patients had a history of two or more previous treatment failures, and 25% had a known history of penicillin intolerance.

Follow-up endoscopy, including histology and H. pylori culture, was performed 6–8 weeks after treatment. Clinical failure was defined as at least one positive biopsy-based test or a positive urea breath test.

Four patients discontinued treatment prematurely because of adverse events, and two were lost to follow-up. Successful eradication of H. pylori infection was confirmed in 70 of the 86 patients (81%) for whom follow-up endoscopy was available.

In the 16 patients who were deemed treatment failures, posttreatment resistance to rifampicin was detected in 5 patients, and resistance to ciprofloxacin in 3. Minor adverse events occurred in 57% of patients and commonly included nausea, headache, and muscle pain.

Although secondary resistance can occur, the 1-week, once-daily therapy is safe, is at least as effective as quadruple therapy, and may be particularly useful for patients with an intolerance to penicillin, concluded Dr. Miehlke of the Technical University Hospital in Dresden, Germany.

Results from a second study he presented demonstrated that rifabutin-based triple therapy was comparable to high-dose dual therapy for treatment-resistant H. pylori, and that sequential therapy is both possible and effective.

In that study, 145 patients with H. pylori infection who were resistant to both metronidazole and clarithromycin were prospectively randomized to receive one of two regimens: either twice-daily therapy for 7 days with esomeprazole 20 mg, rifabutin 150 mg, and amoxicillin 1,000 mg; or thrice-daily therapy for 14 days with omeprazole 40 mg and amoxicillin 1,000 mg.

Indications for treatment included peptic ulcer disease (37%), nonulcer dyspepsia (46.6%), gastroesophageal reflux disease (2.7%), and other diagnoses (13.7%). Two-thirds of the patients (68%) had failed two or more previous treatment regimens.

Six patients discontinued treatment prematurely due to side effects, and three were lost to follow-up.

Eradication of H. pylori infection was achieved in 78% of triple-therapy patients (54/69) and 75% of high-dose, dual-therapy patients (50/67), according to the per protocol analysis. By the intent-to-treat analysis, the figures were 74% vs. 70%. The difference between the two groups was not statistically significant, Dr. Miehlke said.

Seven of 10 patients who failed high-dose dual therapy were cured by crossover to triple therapy.

Eight of 10 patients who failed triple therapy were cured by crossover to high-dose dual therapy.

Posttreatment resistance to amoxicillin or rifabutin was not detected. There were more adverse events reported by patients who were given triple therapy (35%) than by those who received dual therapy (20%). The most common events reported were nausea, diarrhea, headache, and erythema.

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Improve Antibiotic Compliance With Short Course

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NICE, FRANCE — Clinicians should consider shorter, less burdensome regimens as part of an overall strategy to improve antibiotic compliance, Dr. Thomas File Jr. said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

High cure rates are possible with high-dose, short-course therapy when a potent, rapidly acting antibacterial agent is used, and pharmacodynamic principles are applied.

Respiratory tract infections, such as pneumonia, are traditionally treated with a 7- to 14-day course of antibiotics. But findings from in vitro and in vivo studies suggest that pathogens can be eradicated in 24–48 hours with effective agents. “So why do we need to use 7–14 days?” Dr. File said.

Evaluations of shorter-course therapies include a study in which once-daily telithromycin 800 mg was shown to be equivalent to twice-daily clarithromycin 500 mg in a 10-day regimen for community-acquired pneumonia (Clin. Ther. 2004;26:48–62). Similarly, levofloxacin 750 mg for 5 days was as effective as 10 days of levofloxacin 500 mg in patients with mild to severe community-acquired pneumonia (Clin. Infec. Dis. 2003;37:752–60).

More recently, phase III randomized trials have shown that a single 2-g oral dose of azithromycin microspheres (Zmax) was comparable to a 7-day regimen of levofloxacin 500 mg/day in patients with community-acquired pneumonia (Antimicrob. Agents Chemother. 2005;49: 4035–41) and comparable to 10 days of levofloxacin in patients with acute bacterial sinusitis (Otolaryngol. Head Neck Surg. 2005;133:194–200).

Zmax, which was approved in the United States in 2005, has a unique microsphere formulation that releases the active drug in the small intestine rather than stomach, reducing gastrointestinal side effects, said Dr. File, who has received honorarium and clinical support from Pfizer Inc., which markets Zmax. Unpublished pharmacokinetic data suggest that five to eight times more drug is delivered to the site of infection, which maximizes bacterial eradication and thereby helps reduce resistance, he said.

Clinicians should familiarize themselves with the pharmacokinetic and pharmacodynamic parameters of an individual agent and its minimum inhibitory concentration to improve bacterial eradication. Local resistance patterns also should be taken into consideration when choosing an antibiotic. For example, penicillin resistance in isolates of Streptococcus pneumoniae during 1998–2000 was just 4% in the Netherlands but a staggering 32% in Ireland (J. Antimicrob. Chemother. 2003;52:229–46).

Finally, Dr. File urged physicians to educate their patients about proper antimicrobial use to reduce patient expectations and the pressure on physicians to prescribe unwarranted antibiotics, both of which have contributed to overprescribing of these drugs.

“Patient satisfaction is not compromised by the absence of an antibiotic prescription, provided that the patient understands the reasons,” said Dr. File, professor of internal medicine, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio.

Pathogens can be eradicated in 24–48 hours with effective agents. 'So why do we need to use 7–14 days?' DR. FILE

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NICE, FRANCE — Clinicians should consider shorter, less burdensome regimens as part of an overall strategy to improve antibiotic compliance, Dr. Thomas File Jr. said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

High cure rates are possible with high-dose, short-course therapy when a potent, rapidly acting antibacterial agent is used, and pharmacodynamic principles are applied.

Respiratory tract infections, such as pneumonia, are traditionally treated with a 7- to 14-day course of antibiotics. But findings from in vitro and in vivo studies suggest that pathogens can be eradicated in 24–48 hours with effective agents. “So why do we need to use 7–14 days?” Dr. File said.

Evaluations of shorter-course therapies include a study in which once-daily telithromycin 800 mg was shown to be equivalent to twice-daily clarithromycin 500 mg in a 10-day regimen for community-acquired pneumonia (Clin. Ther. 2004;26:48–62). Similarly, levofloxacin 750 mg for 5 days was as effective as 10 days of levofloxacin 500 mg in patients with mild to severe community-acquired pneumonia (Clin. Infec. Dis. 2003;37:752–60).

More recently, phase III randomized trials have shown that a single 2-g oral dose of azithromycin microspheres (Zmax) was comparable to a 7-day regimen of levofloxacin 500 mg/day in patients with community-acquired pneumonia (Antimicrob. Agents Chemother. 2005;49: 4035–41) and comparable to 10 days of levofloxacin in patients with acute bacterial sinusitis (Otolaryngol. Head Neck Surg. 2005;133:194–200).

Zmax, which was approved in the United States in 2005, has a unique microsphere formulation that releases the active drug in the small intestine rather than stomach, reducing gastrointestinal side effects, said Dr. File, who has received honorarium and clinical support from Pfizer Inc., which markets Zmax. Unpublished pharmacokinetic data suggest that five to eight times more drug is delivered to the site of infection, which maximizes bacterial eradication and thereby helps reduce resistance, he said.

Clinicians should familiarize themselves with the pharmacokinetic and pharmacodynamic parameters of an individual agent and its minimum inhibitory concentration to improve bacterial eradication. Local resistance patterns also should be taken into consideration when choosing an antibiotic. For example, penicillin resistance in isolates of Streptococcus pneumoniae during 1998–2000 was just 4% in the Netherlands but a staggering 32% in Ireland (J. Antimicrob. Chemother. 2003;52:229–46).

Finally, Dr. File urged physicians to educate their patients about proper antimicrobial use to reduce patient expectations and the pressure on physicians to prescribe unwarranted antibiotics, both of which have contributed to overprescribing of these drugs.

“Patient satisfaction is not compromised by the absence of an antibiotic prescription, provided that the patient understands the reasons,” said Dr. File, professor of internal medicine, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio.

Pathogens can be eradicated in 24–48 hours with effective agents. 'So why do we need to use 7–14 days?' DR. FILE

NICE, FRANCE — Clinicians should consider shorter, less burdensome regimens as part of an overall strategy to improve antibiotic compliance, Dr. Thomas File Jr. said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

High cure rates are possible with high-dose, short-course therapy when a potent, rapidly acting antibacterial agent is used, and pharmacodynamic principles are applied.

Respiratory tract infections, such as pneumonia, are traditionally treated with a 7- to 14-day course of antibiotics. But findings from in vitro and in vivo studies suggest that pathogens can be eradicated in 24–48 hours with effective agents. “So why do we need to use 7–14 days?” Dr. File said.

Evaluations of shorter-course therapies include a study in which once-daily telithromycin 800 mg was shown to be equivalent to twice-daily clarithromycin 500 mg in a 10-day regimen for community-acquired pneumonia (Clin. Ther. 2004;26:48–62). Similarly, levofloxacin 750 mg for 5 days was as effective as 10 days of levofloxacin 500 mg in patients with mild to severe community-acquired pneumonia (Clin. Infec. Dis. 2003;37:752–60).

More recently, phase III randomized trials have shown that a single 2-g oral dose of azithromycin microspheres (Zmax) was comparable to a 7-day regimen of levofloxacin 500 mg/day in patients with community-acquired pneumonia (Antimicrob. Agents Chemother. 2005;49: 4035–41) and comparable to 10 days of levofloxacin in patients with acute bacterial sinusitis (Otolaryngol. Head Neck Surg. 2005;133:194–200).

Zmax, which was approved in the United States in 2005, has a unique microsphere formulation that releases the active drug in the small intestine rather than stomach, reducing gastrointestinal side effects, said Dr. File, who has received honorarium and clinical support from Pfizer Inc., which markets Zmax. Unpublished pharmacokinetic data suggest that five to eight times more drug is delivered to the site of infection, which maximizes bacterial eradication and thereby helps reduce resistance, he said.

Clinicians should familiarize themselves with the pharmacokinetic and pharmacodynamic parameters of an individual agent and its minimum inhibitory concentration to improve bacterial eradication. Local resistance patterns also should be taken into consideration when choosing an antibiotic. For example, penicillin resistance in isolates of Streptococcus pneumoniae during 1998–2000 was just 4% in the Netherlands but a staggering 32% in Ireland (J. Antimicrob. Chemother. 2003;52:229–46).

Finally, Dr. File urged physicians to educate their patients about proper antimicrobial use to reduce patient expectations and the pressure on physicians to prescribe unwarranted antibiotics, both of which have contributed to overprescribing of these drugs.

“Patient satisfaction is not compromised by the absence of an antibiotic prescription, provided that the patient understands the reasons,” said Dr. File, professor of internal medicine, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio.

Pathogens can be eradicated in 24–48 hours with effective agents. 'So why do we need to use 7–14 days?' DR. FILE

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Statins May Offer Protection During Flu Outbreaks

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NICE, FRANCE — A provocative study has identified an association between the use of statins and favorable outcomes during influenza epidemics.

In the retrospective cohort analysis, statin therapy was associated with substantial reductions in mainly respiratory diseases, but also in death from all causes, Dr. Theo Verheij said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

As for the mechanism, it is theorized that statins could have anti-inflammatory properties or an effect on immune status, he said. Three small studies have shown that statins have an anti-inflammatory effect in patients with bacteremia. In addition, a recent study identified an association between statin use and reduced sepsis in patients hospitalized for acute coronary syndrome, ischemic stroke, or revascularization (Lancet 2006;367:372–3).

Dr. Verheij and his colleagues assessed patients aged 50 years or older from the primary care network of the University Medical Center in Utrecht, the Netherlands. The patients were followed up during eight epidemic and nonepidemic influenza seasons from 1998 to 2003, said Dr. Verheij, a professor of general practice with the university.

The primary end point was a composite of community-acquired pneumonia, prednisone-treated acute respiratory disease, MI, stroke, and death from all causes. The analyses were adjusted for age, gender, insurance, medications, medical conditions including diabetes mellitus and psychiatric disorders, and influenza vaccination.

A total of 22,638 patients provided 130,558 person-periods (each influenza season was considered a period). Statin therapy (simvastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin) was used in 6,982 (5.3%) person-periods and influenza vaccinations in 36,556 (28%). The primary end point occurred in 3.2% of person-periods, and most events (72%) were respiratory, he reported.

During influenza epidemics, statin therapy was associated with a 33% reduction in the primary end point (relative risk 0.67), a 26% reduction in respiratory disease (RR 0.74), and a 51% reduction in all-cause mortality (RR 0.49); these results were significantly different from outcomes in patients who were not using statins. The risk of pneumonia was reduced by 28% (RR 0.62) and the risk of acute respiratory disease was reduced by 21% (RR 0.79).

The findings were consistent across subgroups defined by age, cardiovascular disease, or exposure to influenza vaccination. In nonepidemic influenza seasons, there was no significant reduction in risk, except for all-cause death.

A dose-response relationship convinced the investigators that statin therapy provided a protective effect, Dr. Verheij said. Statin therapy was associated with a 33% reduction of any event among patients taking less than two daily defined doses and a 44% reduction among those taking two or more daily defined doses (RR 0.67 and 0.56, respectively, compared with patients who did not use statins).

The findings should be used to direct future studies into potential implications, particularly during pandemics, he said.

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NICE, FRANCE — A provocative study has identified an association between the use of statins and favorable outcomes during influenza epidemics.

In the retrospective cohort analysis, statin therapy was associated with substantial reductions in mainly respiratory diseases, but also in death from all causes, Dr. Theo Verheij said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

As for the mechanism, it is theorized that statins could have anti-inflammatory properties or an effect on immune status, he said. Three small studies have shown that statins have an anti-inflammatory effect in patients with bacteremia. In addition, a recent study identified an association between statin use and reduced sepsis in patients hospitalized for acute coronary syndrome, ischemic stroke, or revascularization (Lancet 2006;367:372–3).

Dr. Verheij and his colleagues assessed patients aged 50 years or older from the primary care network of the University Medical Center in Utrecht, the Netherlands. The patients were followed up during eight epidemic and nonepidemic influenza seasons from 1998 to 2003, said Dr. Verheij, a professor of general practice with the university.

The primary end point was a composite of community-acquired pneumonia, prednisone-treated acute respiratory disease, MI, stroke, and death from all causes. The analyses were adjusted for age, gender, insurance, medications, medical conditions including diabetes mellitus and psychiatric disorders, and influenza vaccination.

A total of 22,638 patients provided 130,558 person-periods (each influenza season was considered a period). Statin therapy (simvastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin) was used in 6,982 (5.3%) person-periods and influenza vaccinations in 36,556 (28%). The primary end point occurred in 3.2% of person-periods, and most events (72%) were respiratory, he reported.

During influenza epidemics, statin therapy was associated with a 33% reduction in the primary end point (relative risk 0.67), a 26% reduction in respiratory disease (RR 0.74), and a 51% reduction in all-cause mortality (RR 0.49); these results were significantly different from outcomes in patients who were not using statins. The risk of pneumonia was reduced by 28% (RR 0.62) and the risk of acute respiratory disease was reduced by 21% (RR 0.79).

The findings were consistent across subgroups defined by age, cardiovascular disease, or exposure to influenza vaccination. In nonepidemic influenza seasons, there was no significant reduction in risk, except for all-cause death.

A dose-response relationship convinced the investigators that statin therapy provided a protective effect, Dr. Verheij said. Statin therapy was associated with a 33% reduction of any event among patients taking less than two daily defined doses and a 44% reduction among those taking two or more daily defined doses (RR 0.67 and 0.56, respectively, compared with patients who did not use statins).

The findings should be used to direct future studies into potential implications, particularly during pandemics, he said.

ELSEVIER GLOBAL MEDICAL NEWS

NICE, FRANCE — A provocative study has identified an association between the use of statins and favorable outcomes during influenza epidemics.

In the retrospective cohort analysis, statin therapy was associated with substantial reductions in mainly respiratory diseases, but also in death from all causes, Dr. Theo Verheij said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

As for the mechanism, it is theorized that statins could have anti-inflammatory properties or an effect on immune status, he said. Three small studies have shown that statins have an anti-inflammatory effect in patients with bacteremia. In addition, a recent study identified an association between statin use and reduced sepsis in patients hospitalized for acute coronary syndrome, ischemic stroke, or revascularization (Lancet 2006;367:372–3).

Dr. Verheij and his colleagues assessed patients aged 50 years or older from the primary care network of the University Medical Center in Utrecht, the Netherlands. The patients were followed up during eight epidemic and nonepidemic influenza seasons from 1998 to 2003, said Dr. Verheij, a professor of general practice with the university.

The primary end point was a composite of community-acquired pneumonia, prednisone-treated acute respiratory disease, MI, stroke, and death from all causes. The analyses were adjusted for age, gender, insurance, medications, medical conditions including diabetes mellitus and psychiatric disorders, and influenza vaccination.

A total of 22,638 patients provided 130,558 person-periods (each influenza season was considered a period). Statin therapy (simvastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin) was used in 6,982 (5.3%) person-periods and influenza vaccinations in 36,556 (28%). The primary end point occurred in 3.2% of person-periods, and most events (72%) were respiratory, he reported.

During influenza epidemics, statin therapy was associated with a 33% reduction in the primary end point (relative risk 0.67), a 26% reduction in respiratory disease (RR 0.74), and a 51% reduction in all-cause mortality (RR 0.49); these results were significantly different from outcomes in patients who were not using statins. The risk of pneumonia was reduced by 28% (RR 0.62) and the risk of acute respiratory disease was reduced by 21% (RR 0.79).

The findings were consistent across subgroups defined by age, cardiovascular disease, or exposure to influenza vaccination. In nonepidemic influenza seasons, there was no significant reduction in risk, except for all-cause death.

A dose-response relationship convinced the investigators that statin therapy provided a protective effect, Dr. Verheij said. Statin therapy was associated with a 33% reduction of any event among patients taking less than two daily defined doses and a 44% reduction among those taking two or more daily defined doses (RR 0.67 and 0.56, respectively, compared with patients who did not use statins).

The findings should be used to direct future studies into potential implications, particularly during pandemics, he said.

ELSEVIER GLOBAL MEDICAL NEWS

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