Patrice Wendling

CHICAGO — Exogenous testosterone, either alone or with finasteride for 36 months, did not significantly improve cognition in a randomized, placebo-controlled trial involving healthy older men, 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 were randomly assigned to receive one of three regimens: 200 mg of IM testosterone every 2 weeks with placebo pills, 200 mg of IM testosterone every 2 weeks with 5 mg of finasteride daily, or placebo injections and placebo pills.

Cognitive testing was performed at baseline, 4 months, and 36 months. Serum hormone levels also were measured at the indicated intervals. Of 69 men who completed baseline testing, 46 completed 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-month or 36-month evaluations, reported Dr. Vaughan of Emory University in Atlanta.

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.

CHICAGO — Exogenous testosterone, either alone or with finasteride for 36 months, did not significantly improve cognition in a randomized, placebo-controlled trial involving healthy older men, 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 were randomly assigned to receive one of three regimens: 200 mg of IM testosterone every 2 weeks with placebo pills, 200 mg of IM testosterone every 2 weeks with 5 mg of finasteride daily, or placebo injections and placebo pills.

Cognitive testing was performed at baseline, 4 months, and 36 months. Serum hormone levels also were measured at the indicated intervals. Of 69 men who completed baseline testing, 46 completed 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-month or 36-month evaluations, reported Dr. Vaughan of Emory University in Atlanta.

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.

CHICAGO — Exogenous testosterone, either alone or with finasteride for 36 months, did not significantly improve cognition in a randomized, placebo-controlled trial involving healthy older men, 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 were randomly assigned to receive one of three regimens: 200 mg of IM testosterone every 2 weeks with placebo pills, 200 mg of IM testosterone every 2 weeks with 5 mg of finasteride daily, or placebo injections and placebo pills.

Cognitive testing was performed at baseline, 4 months, and 36 months. Serum hormone levels also were measured at the indicated intervals. Of 69 men who completed baseline testing, 46 completed 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-month or 36-month evaluations, reported Dr. Vaughan of Emory University in Atlanta.

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.

CHICAGO — Methylphenidate may be effective in the treatment of apathy associated with dementia of the Alzheimer's 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's 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 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).

Subjective improvement was noted by caregivers, who reported increased energy, ambition, spontaneity, and motivation in the patients. One caregiver reported that the patient was monitoring his medications better and started taking care of his finances again after a long hiatus.

None of the patients discontinued medication because of adverse events. In one patient, the dose of methylphenidate was reduced because of appetite loss possibly related to treatment, Dr. Padala reported.

The study was funded by the Nancy and Ronald Reagan Alzheimer's Scholarship Fund, established at the University of Nebraska to support Alzheimer's disease research.

CHICAGO — Methylphenidate may be effective in the treatment of apathy associated with dementia of the Alzheimer's 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's 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 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).

Subjective improvement was noted by caregivers, who reported increased energy, ambition, spontaneity, and motivation in the patients. One caregiver reported that the patient was monitoring his medications better and started taking care of his finances again after a long hiatus.

None of the patients discontinued medication because of adverse events. In one patient, the dose of methylphenidate was reduced because of appetite loss possibly related to treatment, Dr. Padala reported.

The study was funded by the Nancy and Ronald Reagan Alzheimer's Scholarship Fund, established at the University of Nebraska to support Alzheimer's disease research.

CHICAGO — Methylphenidate may be effective in the treatment of apathy associated with dementia of the Alzheimer's 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's 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 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).

Subjective improvement was noted by caregivers, who reported increased energy, ambition, spontaneity, and motivation in the patients. One caregiver reported that the patient was monitoring his medications better and started taking care of his finances again after a long hiatus.

None of the patients discontinued medication because of adverse events. In one patient, the dose of methylphenidate was reduced because of appetite loss possibly related to treatment, Dr. Padala reported.

The study was funded by the Nancy and Ronald Reagan Alzheimer's Scholarship Fund, established at the University of Nebraska to support Alzheimer's disease research.

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 severe, 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. “They give a new evidence-based option for treatment, which gives hope for a better quality of life in the final phase of this devastating disease.”

Currently, 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, although the higher 10-mg dose did not provide significantly greater clinical benefit in previous clinical trials.

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. Their mean age was 78 years, their mean Mini-Mental State Exam score was 7.5, and the majority (86.3%) had Functional Assessment Staging scores of 6.a–6.e.

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 with Caregiver Input (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. The intent-to-treat population consisted of all patients who were randomized, received at least one dose of either donepezil or placebo, and had a baseline and at least one postbaseline efficacy value.

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, she said.

The collapsed category CIBIC-plus analysis significantly favored donepezil at week 24 in the intent-to-treat population and in patients who completed the study. Among donepezil-treated patients, 28% improved, 38% had no change, and 34% worsened, compared with 23%, 29%, and 48% of placebo patients, respectively.

Most reported adverse events were mild to moderate (74%), the most common of which were diarrhea, nausea, and insomnia. Placebo patients reported more serious and severe adverse events than donepezil-treated patients. However, more patients discontinued treatment because of adverse events in the donepezil group than in the placebo group (18.3% vs. 10.8%, respectively), Dr. Black reported.

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 severe, 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. “They give a new evidence-based option for treatment, which gives hope for a better quality of life in the final phase of this devastating disease.”

Currently, 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, although the higher 10-mg dose did not provide significantly greater clinical benefit in previous clinical trials.

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. Their mean age was 78 years, their mean Mini-Mental State Exam score was 7.5, and the majority (86.3%) had Functional Assessment Staging scores of 6.a–6.e.

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 with Caregiver Input (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. The intent-to-treat population consisted of all patients who were randomized, received at least one dose of either donepezil or placebo, and had a baseline and at least one postbaseline efficacy value.

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, she said.

The collapsed category CIBIC-plus analysis significantly favored donepezil at week 24 in the intent-to-treat population and in patients who completed the study. Among donepezil-treated patients, 28% improved, 38% had no change, and 34% worsened, compared with 23%, 29%, and 48% of placebo patients, respectively.

Most reported adverse events were mild to moderate (74%), the most common of which were diarrhea, nausea, and insomnia. Placebo patients reported more serious and severe adverse events than donepezil-treated patients. However, more patients discontinued treatment because of adverse events in the donepezil group than in the placebo group (18.3% vs. 10.8%, respectively), Dr. Black reported.

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 severe, 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. “They give a new evidence-based option for treatment, which gives hope for a better quality of life in the final phase of this devastating disease.”

Currently, 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, although the higher 10-mg dose did not provide significantly greater clinical benefit in previous clinical trials.

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. Their mean age was 78 years, their mean Mini-Mental State Exam score was 7.5, and the majority (86.3%) had Functional Assessment Staging scores of 6.a–6.e.

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 with Caregiver Input (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. The intent-to-treat population consisted of all patients who were randomized, received at least one dose of either donepezil or placebo, and had a baseline and at least one postbaseline efficacy value.

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, she said.

The collapsed category CIBIC-plus analysis significantly favored donepezil at week 24 in the intent-to-treat population and in patients who completed the study. Among donepezil-treated patients, 28% improved, 38% had no change, and 34% worsened, compared with 23%, 29%, and 48% of placebo patients, respectively.

Most reported adverse events were mild to moderate (74%), the most common of which were diarrhea, nausea, and insomnia. Placebo patients reported more serious and severe adverse events than donepezil-treated patients. However, more patients discontinued treatment because of adverse events in the donepezil group than in the placebo group (18.3% vs. 10.8%, respectively), Dr. Black reported.

MIAMI BEACH — B-cell depletion with rituximab may be a useful treatment option for severe refractory Wegener's granulomatosis when patients are intolerant or have a contraindication to cyclophosphamide, Dr. Ulrich Specks said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Rituximab appears safe and effective for inducing and maintaining remission in patients with active severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, Dr. Specks and colleagues at the Mayo Clinic, Rochester, Minn., reported.

In February, Genentech Inc. received an orphan product designation for rituximab (Rituxan) for the treatment of ANCA-associated vasculitis including Wegener's, microscopic polyangiitis, and Churg-Strauss syndrome.

In Dr. Speck and colleagues' prospective, open-label, industry-supported pilot trial, 10 patients with active disease received oral prednisone 1 mg/kg per day and four weekly infusions of rituximab 375 mg/m

Clinically, all patients went into complete remission by 3 months, and were tapered off prednisone by 5.5 months, Dr. Specks said. One patient experienced a clinical flare and was put back into remission after retreatment with rituximab and prednisone.

ANCA titers dropped in all patients, and generally did not rise until after B cell reconstitution. By 12 months, B cells had returned in 9 of 10 patients. “We didn't observe relapses in the absence of B cells and didn't observe relapses in the absence of ANCA-titer increases,” he said. Overall, the regimen was very well tolerated. There was only 1 infusion reaction, 1 case of influenza, 13 urinary tract infections in five patients, 2 herpes zoster cases, and no antichimeric antibodies developed.

Although the results compared well with earlier published small and single-case trials, larger studies should be conducted to determine whether rituximab should replace cyclophosphamide as the standard of care, he said.

While Dr. Specks gave rituximab a conditional nod, he noted that antitumor necrotic factor therapy provides no added benefit on top of standard therapy and should be avoided in patients who have received cyclophosphamide. He cited the high rates of adverse events, particularly the increased incidence of cancers observed in the Wegener's Granulomatosis Etanercept Trial, in which he was an investigator.

MIAMI BEACH — B-cell depletion with rituximab may be a useful treatment option for severe refractory Wegener's granulomatosis when patients are intolerant or have a contraindication to cyclophosphamide, Dr. Ulrich Specks said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Rituximab appears safe and effective for inducing and maintaining remission in patients with active severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, Dr. Specks and colleagues at the Mayo Clinic, Rochester, Minn., reported.

In February, Genentech Inc. received an orphan product designation for rituximab (Rituxan) for the treatment of ANCA-associated vasculitis including Wegener's, microscopic polyangiitis, and Churg-Strauss syndrome.

In Dr. Speck and colleagues' prospective, open-label, industry-supported pilot trial, 10 patients with active disease received oral prednisone 1 mg/kg per day and four weekly infusions of rituximab 375 mg/m

Clinically, all patients went into complete remission by 3 months, and were tapered off prednisone by 5.5 months, Dr. Specks said. One patient experienced a clinical flare and was put back into remission after retreatment with rituximab and prednisone.

ANCA titers dropped in all patients, and generally did not rise until after B cell reconstitution. By 12 months, B cells had returned in 9 of 10 patients. “We didn't observe relapses in the absence of B cells and didn't observe relapses in the absence of ANCA-titer increases,” he said. Overall, the regimen was very well tolerated. There was only 1 infusion reaction, 1 case of influenza, 13 urinary tract infections in five patients, 2 herpes zoster cases, and no antichimeric antibodies developed.

Although the results compared well with earlier published small and single-case trials, larger studies should be conducted to determine whether rituximab should replace cyclophosphamide as the standard of care, he said.

While Dr. Specks gave rituximab a conditional nod, he noted that antitumor necrotic factor therapy provides no added benefit on top of standard therapy and should be avoided in patients who have received cyclophosphamide. He cited the high rates of adverse events, particularly the increased incidence of cancers observed in the Wegener's Granulomatosis Etanercept Trial, in which he was an investigator.

MIAMI BEACH — B-cell depletion with rituximab may be a useful treatment option for severe refractory Wegener's granulomatosis when patients are intolerant or have a contraindication to cyclophosphamide, Dr. Ulrich Specks said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Rituximab appears safe and effective for inducing and maintaining remission in patients with active severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, Dr. Specks and colleagues at the Mayo Clinic, Rochester, Minn., reported.

In February, Genentech Inc. received an orphan product designation for rituximab (Rituxan) for the treatment of ANCA-associated vasculitis including Wegener's, microscopic polyangiitis, and Churg-Strauss syndrome.

In Dr. Speck and colleagues' prospective, open-label, industry-supported pilot trial, 10 patients with active disease received oral prednisone 1 mg/kg per day and four weekly infusions of rituximab 375 mg/m

Clinically, all patients went into complete remission by 3 months, and were tapered off prednisone by 5.5 months, Dr. Specks said. One patient experienced a clinical flare and was put back into remission after retreatment with rituximab and prednisone.

ANCA titers dropped in all patients, and generally did not rise until after B cell reconstitution. By 12 months, B cells had returned in 9 of 10 patients. “We didn't observe relapses in the absence of B cells and didn't observe relapses in the absence of ANCA-titer increases,” he said. Overall, the regimen was very well tolerated. There was only 1 infusion reaction, 1 case of influenza, 13 urinary tract infections in five patients, 2 herpes zoster cases, and no antichimeric antibodies developed.

Although the results compared well with earlier published small and single-case trials, larger studies should be conducted to determine whether rituximab should replace cyclophosphamide as the standard of care, he said.

While Dr. Specks gave rituximab a conditional nod, he noted that antitumor necrotic factor therapy provides no added benefit on top of standard therapy and should be avoided in patients who have received cyclophosphamide. He cited the high rates of adverse events, particularly the increased incidence of cancers observed in the Wegener's Granulomatosis Etanercept Trial, in which he was an investigator.

NICE, FRANCE — A new study suggests that stress hyperglycemia may be an important predictor of morbidity and mortality in nondiabetic patients with sepsis.

The investigation included 242 patients without diabetes who were hospitalized with severe sepsis in three hospitals in southwestern Greece during a 1-year period.

Hyperglycemia was defined as an admission or in-hospital fasting glucose level of 126 mg/dL or more, or a random blood glucose level of 200 mg/dL or more on two or more evaluations.

Stress hyperglycemia—defined as a transient elevation of blood glucose levels due to various factors including stress, injury, and surgery—was present in 20% of the participating patients, Dr. Lydia Leonidou reported at the 16th European Congress on Clinical Microbiology and Infectious Diseases.

Moreover, a significantly higher percentage of septic patients with stress hyperglycemia died, compared with those participants who had normal glucose levels (43.4% vs. 13.2%), the investigator reported.

Stress hyperglycemia was not related to a genetic predisposition to diabetes mellitus. Only 6% of hyperglycemic patients had a first-degree relative with diabetes, compared with 11% of normal glycemic patients, reported Dr. Leonidou and her colleagues at the University of Patras (Greece).

Sources of infection in all patients were: respiratory tract 42%, urinary tract 35%, intraabdominal 16%, central nervous system 3%, soft tissue 3%, and endocarditis 1%.

Hyperglycemic patients were older than normal glycemic patients, but the difference was not statistically significant (73.4 years vs. 65.7).

There was no significant difference in gender, body mass index, C-reactive protein, blood cultures, and hospitalization days between groups.

Hemoglobin A_1c levels were significantly higher among hyperglycemia patients (5.73% vs. 5.44%) but were within the normal range of 4%–5.9%.

The investigators also found that patients with stress hyperglycemia had a significantly higher sepsis-related organ failure assessment (SOFA) score than patients with normal glycemia (mean 4.9 vs. 2.9).

This finding led some of the people who were attending the meeting to question whether stress hyperglycemia caused poor outcomes or was just another surrogate marker such as the SOFA score itself.

The study's lead author Dr. Charalambos Gogos responded, “We believe that hyperglycemia is not [just] a surrogate marker, but something you have to fight in your patients with good glycemic control.”

NICE, FRANCE — A new study suggests that stress hyperglycemia may be an important predictor of morbidity and mortality in nondiabetic patients with sepsis.

The investigation included 242 patients without diabetes who were hospitalized with severe sepsis in three hospitals in southwestern Greece during a 1-year period.

Hyperglycemia was defined as an admission or in-hospital fasting glucose level of 126 mg/dL or more, or a random blood glucose level of 200 mg/dL or more on two or more evaluations.

Stress hyperglycemia—defined as a transient elevation of blood glucose levels due to various factors including stress, injury, and surgery—was present in 20% of the participating patients, Dr. Lydia Leonidou reported at the 16th European Congress on Clinical Microbiology and Infectious Diseases.

Moreover, a significantly higher percentage of septic patients with stress hyperglycemia died, compared with those participants who had normal glucose levels (43.4% vs. 13.2%), the investigator reported.

Stress hyperglycemia was not related to a genetic predisposition to diabetes mellitus. Only 6% of hyperglycemic patients had a first-degree relative with diabetes, compared with 11% of normal glycemic patients, reported Dr. Leonidou and her colleagues at the University of Patras (Greece).

Sources of infection in all patients were: respiratory tract 42%, urinary tract 35%, intraabdominal 16%, central nervous system 3%, soft tissue 3%, and endocarditis 1%.

Hyperglycemic patients were older than normal glycemic patients, but the difference was not statistically significant (73.4 years vs. 65.7).

There was no significant difference in gender, body mass index, C-reactive protein, blood cultures, and hospitalization days between groups.

Hemoglobin A_1c levels were significantly higher among hyperglycemia patients (5.73% vs. 5.44%) but were within the normal range of 4%–5.9%.

The investigators also found that patients with stress hyperglycemia had a significantly higher sepsis-related organ failure assessment (SOFA) score than patients with normal glycemia (mean 4.9 vs. 2.9).

This finding led some of the people who were attending the meeting to question whether stress hyperglycemia caused poor outcomes or was just another surrogate marker such as the SOFA score itself.

The study's lead author Dr. Charalambos Gogos responded, “We believe that hyperglycemia is not [just] a surrogate marker, but something you have to fight in your patients with good glycemic control.”

NICE, FRANCE — A new study suggests that stress hyperglycemia may be an important predictor of morbidity and mortality in nondiabetic patients with sepsis.

The investigation included 242 patients without diabetes who were hospitalized with severe sepsis in three hospitals in southwestern Greece during a 1-year period.

Hyperglycemia was defined as an admission or in-hospital fasting glucose level of 126 mg/dL or more, or a random blood glucose level of 200 mg/dL or more on two or more evaluations.

Stress hyperglycemia—defined as a transient elevation of blood glucose levels due to various factors including stress, injury, and surgery—was present in 20% of the participating patients, Dr. Lydia Leonidou reported at the 16th European Congress on Clinical Microbiology and Infectious Diseases.

Moreover, a significantly higher percentage of septic patients with stress hyperglycemia died, compared with those participants who had normal glucose levels (43.4% vs. 13.2%), the investigator reported.

Stress hyperglycemia was not related to a genetic predisposition to diabetes mellitus. Only 6% of hyperglycemic patients had a first-degree relative with diabetes, compared with 11% of normal glycemic patients, reported Dr. Leonidou and her colleagues at the University of Patras (Greece).

Sources of infection in all patients were: respiratory tract 42%, urinary tract 35%, intraabdominal 16%, central nervous system 3%, soft tissue 3%, and endocarditis 1%.

Hyperglycemic patients were older than normal glycemic patients, but the difference was not statistically significant (73.4 years vs. 65.7).

There was no significant difference in gender, body mass index, C-reactive protein, blood cultures, and hospitalization days between groups.

Hemoglobin A_1c levels were significantly higher among hyperglycemia patients (5.73% vs. 5.44%) but were within the normal range of 4%–5.9%.

The investigators also found that patients with stress hyperglycemia had a significantly higher sepsis-related organ failure assessment (SOFA) score than patients with normal glycemia (mean 4.9 vs. 2.9).

This finding led some of the people who were attending the meeting to question whether stress hyperglycemia caused poor outcomes or was just another surrogate marker such as the SOFA score itself.

The study's lead author Dr. Charalambos Gogos responded, “We believe that hyperglycemia is not [just] a surrogate marker, but something you have to fight in your patients with good glycemic control.”

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 the cornerstone of the World Health Organization's Global Patient Safety Challenge, which 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 that included an evidence-based guideline and e-learning program describing how and when to perform alcohol-based hand disinfection.

Trained observers recorded potential opportunities for hand disinfection during four surveys during 2004–2005. Interobserver variation was minimized through audits.

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 liters at baseline to 2,500 liters in 2005.

But 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, and is conducting a prevalence study of other nosocomial infections, Dr. Laustsen said in an interview.

As shown in other studies, compliance in 2005 for physicians was lower (20%) than for nurses (44%) and other health care workers (25%).

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 the cornerstone of the World Health Organization's Global Patient Safety Challenge, which 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 that included an evidence-based guideline and e-learning program describing how and when to perform alcohol-based hand disinfection.

Trained observers recorded potential opportunities for hand disinfection during four surveys during 2004–2005. Interobserver variation was minimized through audits.

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 liters at baseline to 2,500 liters in 2005.

But 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, and is conducting a prevalence study of other nosocomial infections, Dr. Laustsen said in an interview.

As shown in other studies, compliance in 2005 for physicians was lower (20%) than for nurses (44%) and other health care workers (25%).

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 the cornerstone of the World Health Organization's Global Patient Safety Challenge, which 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 that included an evidence-based guideline and e-learning program describing how and when to perform alcohol-based hand disinfection.

Trained observers recorded potential opportunities for hand disinfection during four surveys during 2004–2005. Interobserver variation was minimized through audits.

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 liters at baseline to 2,500 liters in 2005.

But 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, and is conducting a prevalence study of other nosocomial infections, Dr. Laustsen said in an interview.

As shown in other studies, compliance in 2005 for physicians was lower (20%) than for nurses (44%) and other health care workers (25%).

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 in the past 12 months. Noncompliance was defined as missing a dose or day, or having any drug left over. A total of 4,088 patients were included in the study, which was sponsored by Pfizer Inc.

The preliminary results, presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases, included:

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

▸ Of those surveyed, 8 in 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, according to the study.

He suggested that educational efforts be tailored to address intercountry variations and that physicians educate their patients about proper antibiotic use.

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 in the past 12 months. Noncompliance was defined as missing a dose or day, or having any drug left over. A total of 4,088 patients were included in the study, which was sponsored by Pfizer Inc.

The preliminary results, presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases, included:

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

▸ Of those surveyed, 8 in 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, according to the study.

He suggested that educational efforts be tailored to address intercountry variations and that physicians educate their patients about proper antibiotic use.

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 in the past 12 months. Noncompliance was defined as missing a dose or day, or having any drug left over. A total of 4,088 patients were included in the study, which was sponsored by Pfizer Inc.

The preliminary results, presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases, included:

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

▸ Of those surveyed, 8 in 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, according to the study.

He suggested that educational efforts be tailored to address intercountry variations and that physicians educate their patients about proper antibiotic use.

ELSEVIER GLOBAL MEDICAL NEWS

NICE, FRANCE — New research suggests that the prevalence of Pseudomonas aeruginosa is higher in patients hospitalized for acute chronic obstructive pulmonary disease exacerbation than in ambulatory patients.

Presence of the gram-negative bacterium in sputum was associated with worse functional outcomes and with a strong history of smoking in a study of 188 hospitalized COPD patients, Dr. Carolina Garcia Vidal said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

Previous studies have reported prevalence rates for P. aeruginosa (PA) ranging from 0.5% to 15% in ambulatory patients.

In one published study, PA was identified in 5.5% of sputum of 118 patients hospitalized with acute exacerbation of COPD with concomitant pneumonia (Intern. Med. J. 2005;35:661–7). In the current study, 23% of cultures were positive for PA.

Dr. Garcia Vidal, of the Hospital de Bellvitge in Barcelona, and her associates prospectively studied 188 consecutive patients admitted to a 450-bed university hospital between June 2003 and September 2004 with an acute exacerbation of COPD, excluding patients with asthma or bronchitis as their primary diagnosis.

Sputum cultures were taken at admission. Patients were followed for 1 year, and spirometry was performed 1 month after discharge.

Among those patients, 32 (17%) had a hospital admission in the previous month; 116 (62%) had taken antimicrobials in the previous 3 months; and 106 (56%) had bronchiectasis. Their mean age was 72 years, and 95% were male.

A total of 106 patients were readmitted for another episode of acute exacerbation. A valid sputum culture was collected in 220 of 469 episodes. One microorganism was present in 117 episodes, two microorganisms in 93, and three in 10 episodes.

P. aeruginosa was present in 51 (23%) cultures, Haemophilus influenzae in 24 (11%), Streptococcus pneumoniae in 21 (9.5%), Enterobacteriaceae in 8 (4%), and normal flora in 159 (72%). Patients with bacterial infection had a forced expiratory volume in 1 second (FEV1) significantly lower than those with negative sputum cultures, she said.

The presence of P. aeruginosa in patients was associated with a significantly lower FEV1 (37.9 vs. 42.7), significantly worse 6-minute walking test (207 meters vs. 324 meters), and significantly greater oxygen use at home (44% vs. 22%).

History of pack-years of smoking was significantly higher in PA patients than in non-PA patients (80.2 vs. 56.2).

P. aeruginosa was resistant to ciprofloxacin in only three patients. “The majority of P. aeruginosa isolates remain susceptible to fluoroquinolones, and these drugs should be considered in the empirical treatment of COPD exacerbations in patients admitted to the hospital with a history of previous smoking and severe functional impairment,” said Dr. Garcia Vidal.

NICE, FRANCE — New research suggests that the prevalence of Pseudomonas aeruginosa is higher in patients hospitalized for acute chronic obstructive pulmonary disease exacerbation than in ambulatory patients.

Presence of the gram-negative bacterium in sputum was associated with worse functional outcomes and with a strong history of smoking in a study of 188 hospitalized COPD patients, Dr. Carolina Garcia Vidal said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

Previous studies have reported prevalence rates for P. aeruginosa (PA) ranging from 0.5% to 15% in ambulatory patients.

In one published study, PA was identified in 5.5% of sputum of 118 patients hospitalized with acute exacerbation of COPD with concomitant pneumonia (Intern. Med. J. 2005;35:661–7). In the current study, 23% of cultures were positive for PA.

Dr. Garcia Vidal, of the Hospital de Bellvitge in Barcelona, and her associates prospectively studied 188 consecutive patients admitted to a 450-bed university hospital between June 2003 and September 2004 with an acute exacerbation of COPD, excluding patients with asthma or bronchitis as their primary diagnosis.

Sputum cultures were taken at admission. Patients were followed for 1 year, and spirometry was performed 1 month after discharge.

Among those patients, 32 (17%) had a hospital admission in the previous month; 116 (62%) had taken antimicrobials in the previous 3 months; and 106 (56%) had bronchiectasis. Their mean age was 72 years, and 95% were male.

A total of 106 patients were readmitted for another episode of acute exacerbation. A valid sputum culture was collected in 220 of 469 episodes. One microorganism was present in 117 episodes, two microorganisms in 93, and three in 10 episodes.

P. aeruginosa was present in 51 (23%) cultures, Haemophilus influenzae in 24 (11%), Streptococcus pneumoniae in 21 (9.5%), Enterobacteriaceae in 8 (4%), and normal flora in 159 (72%). Patients with bacterial infection had a forced expiratory volume in 1 second (FEV1) significantly lower than those with negative sputum cultures, she said.

The presence of P. aeruginosa in patients was associated with a significantly lower FEV1 (37.9 vs. 42.7), significantly worse 6-minute walking test (207 meters vs. 324 meters), and significantly greater oxygen use at home (44% vs. 22%).

History of pack-years of smoking was significantly higher in PA patients than in non-PA patients (80.2 vs. 56.2).

P. aeruginosa was resistant to ciprofloxacin in only three patients. “The majority of P. aeruginosa isolates remain susceptible to fluoroquinolones, and these drugs should be considered in the empirical treatment of COPD exacerbations in patients admitted to the hospital with a history of previous smoking and severe functional impairment,” said Dr. Garcia Vidal.

NICE, FRANCE — New research suggests that the prevalence of Pseudomonas aeruginosa is higher in patients hospitalized for acute chronic obstructive pulmonary disease exacerbation than in ambulatory patients.

Presence of the gram-negative bacterium in sputum was associated with worse functional outcomes and with a strong history of smoking in a study of 188 hospitalized COPD patients, Dr. Carolina Garcia Vidal said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

Previous studies have reported prevalence rates for P. aeruginosa (PA) ranging from 0.5% to 15% in ambulatory patients.

In one published study, PA was identified in 5.5% of sputum of 118 patients hospitalized with acute exacerbation of COPD with concomitant pneumonia (Intern. Med. J. 2005;35:661–7). In the current study, 23% of cultures were positive for PA.

Dr. Garcia Vidal, of the Hospital de Bellvitge in Barcelona, and her associates prospectively studied 188 consecutive patients admitted to a 450-bed university hospital between June 2003 and September 2004 with an acute exacerbation of COPD, excluding patients with asthma or bronchitis as their primary diagnosis.

Sputum cultures were taken at admission. Patients were followed for 1 year, and spirometry was performed 1 month after discharge.

Among those patients, 32 (17%) had a hospital admission in the previous month; 116 (62%) had taken antimicrobials in the previous 3 months; and 106 (56%) had bronchiectasis. Their mean age was 72 years, and 95% were male.

A total of 106 patients were readmitted for another episode of acute exacerbation. A valid sputum culture was collected in 220 of 469 episodes. One microorganism was present in 117 episodes, two microorganisms in 93, and three in 10 episodes.

P. aeruginosa was present in 51 (23%) cultures, Haemophilus influenzae in 24 (11%), Streptococcus pneumoniae in 21 (9.5%), Enterobacteriaceae in 8 (4%), and normal flora in 159 (72%). Patients with bacterial infection had a forced expiratory volume in 1 second (FEV1) significantly lower than those with negative sputum cultures, she said.

The presence of P. aeruginosa in patients was associated with a significantly lower FEV1 (37.9 vs. 42.7), significantly worse 6-minute walking test (207 meters vs. 324 meters), and significantly greater oxygen use at home (44% vs. 22%).

History of pack-years of smoking was significantly higher in PA patients than in non-PA patients (80.2 vs. 56.2).

P. aeruginosa was resistant to ciprofloxacin in only three patients. “The majority of P. aeruginosa isolates remain susceptible to fluoroquinolones, and these drugs should be considered in the empirical treatment of COPD exacerbations in patients admitted to the hospital with a history of previous smoking and severe functional impairment,” said Dr. Garcia Vidal.

NICE, FRANCE — Tigecycline is as effective as levofloxacin in treating patients hospitalized with community-acquired pneumonia, results of a phase III clinical trial suggest.

Tigecycline appeared safe and was effective against the most common respiratory pathogens that have been observed in patients with community-acquired pneumonia.

There was no evidence of resistance to tigecycline in the study, which was conducted by 62 investigators in 22 countries, Dr. Nathalie Dartois said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

The findings are important in light of the increasing rate of hospitalizations associated with community-acquired pneumonia, and the continued increase in resistance to antibiotics such as penicillin, macrolides, and fluoroquinolones, said Dr. Dartois, of Wyeth Research, Paris; Wyeth Pharmaceuticals Inc. markets tigecycline under the brand name Tygacil and funded the trial.

Levofloxacin, a fluoroquinolone, is sold under the brand name Levaquin.

Tigecycline is a first-in-class glycylcycline that was approved in the United States in June 2005 for treating complicated skin, soft tissue, and intraabdominal infections, and is pending approval in Europe. It has a broad spectrum of activity against gram-positive, gram-negative, anaerobic, atypical, and antibiotic-resistant bacteria, with the exception of Pseudomonas.

Tigecycline's extended postantibiotic effect is probably attributable to its long half-life, which is about 42 hours, Dr. Dartois said.

The study included 428 patients who were hospitalized with community-acquired pneumonia severe enough to require intravenous antibiotic treatment for at least 7 days.

The patients also had fever or hypothermia, new infiltrate seen on chest x-ray within 48 hours of admission, and at least two of the following: cough, purulent sputum, rales, dyspnea, increased white blood cell count, or hypoxemia.

Patients were randomized to tigecycline at an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours, or to levofloxacin 500 mg every 12 or 24 hours.

Coprimary end points of the study were clinical response in 280 clinically evaluable patients and 403 modified intent-to-treat patients assessed 10–21 days after the last dose. Demographics were similar in both treatment groups, and the majority of patients had a Fine pneumonia severity index (PSI) score that put them in risk classes II-IV. About 20% of patients had failed previous antibiotics. Their mean age was 49 years.

Of the 280 clinically evaluable patients, clinical cure was achieved in 128 (89%) of 144 patients in the tigecycline group, and 116 (85%) of 136 patients in the levofloxacin group.

Cure rates by patient PSI scores were 89.5% with tigecycline vs. 87% with levofloxacin in PSI risk class II patients, 85% vs. 83% in risk class III, 91% vs. 83% in risk class IV, and 100% for both agents in risk class V.

In the modified intent-to-treat population, tigecycline cured 170 (84%) of 203 patients and levofloxacin cured 163 (82%) of 200. Cure rates for the two most common isolates at baseline were 96% with tigecycline vs. 92% with levofloxacin for Mycoplasma pneumoniae and 93% vs. 94% for cultured Streptococcus pneumoniae.

Adverse events were reported by 62.5% of patients in the tigecycline group and 47% of patients in the levofloxacin group. Nausea, vomiting, and leukocytosis were significantly more common in tigecycline patients, whereas hypokalemia was significantly more common in levofloxacin patients. Treatment discontinuation rates due to adverse events were similar between the tigecycline and levofloxacin groups (6.5% vs. 8%), Dr. Dartois said.

NICE, FRANCE — Tigecycline is as effective as levofloxacin in treating patients hospitalized with community-acquired pneumonia, results of a phase III clinical trial suggest.

Tigecycline appeared safe and was effective against the most common respiratory pathogens that have been observed in patients with community-acquired pneumonia.

There was no evidence of resistance to tigecycline in the study, which was conducted by 62 investigators in 22 countries, Dr. Nathalie Dartois said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

The findings are important in light of the increasing rate of hospitalizations associated with community-acquired pneumonia, and the continued increase in resistance to antibiotics such as penicillin, macrolides, and fluoroquinolones, said Dr. Dartois, of Wyeth Research, Paris; Wyeth Pharmaceuticals Inc. markets tigecycline under the brand name Tygacil and funded the trial.

Levofloxacin, a fluoroquinolone, is sold under the brand name Levaquin.

Tigecycline is a first-in-class glycylcycline that was approved in the United States in June 2005 for treating complicated skin, soft tissue, and intraabdominal infections, and is pending approval in Europe. It has a broad spectrum of activity against gram-positive, gram-negative, anaerobic, atypical, and antibiotic-resistant bacteria, with the exception of Pseudomonas.

Tigecycline's extended postantibiotic effect is probably attributable to its long half-life, which is about 42 hours, Dr. Dartois said.

The study included 428 patients who were hospitalized with community-acquired pneumonia severe enough to require intravenous antibiotic treatment for at least 7 days.

The patients also had fever or hypothermia, new infiltrate seen on chest x-ray within 48 hours of admission, and at least two of the following: cough, purulent sputum, rales, dyspnea, increased white blood cell count, or hypoxemia.

Patients were randomized to tigecycline at an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours, or to levofloxacin 500 mg every 12 or 24 hours.

Coprimary end points of the study were clinical response in 280 clinically evaluable patients and 403 modified intent-to-treat patients assessed 10–21 days after the last dose. Demographics were similar in both treatment groups, and the majority of patients had a Fine pneumonia severity index (PSI) score that put them in risk classes II-IV. About 20% of patients had failed previous antibiotics. Their mean age was 49 years.

Of the 280 clinically evaluable patients, clinical cure was achieved in 128 (89%) of 144 patients in the tigecycline group, and 116 (85%) of 136 patients in the levofloxacin group.

Cure rates by patient PSI scores were 89.5% with tigecycline vs. 87% with levofloxacin in PSI risk class II patients, 85% vs. 83% in risk class III, 91% vs. 83% in risk class IV, and 100% for both agents in risk class V.

In the modified intent-to-treat population, tigecycline cured 170 (84%) of 203 patients and levofloxacin cured 163 (82%) of 200. Cure rates for the two most common isolates at baseline were 96% with tigecycline vs. 92% with levofloxacin for Mycoplasma pneumoniae and 93% vs. 94% for cultured Streptococcus pneumoniae.

Adverse events were reported by 62.5% of patients in the tigecycline group and 47% of patients in the levofloxacin group. Nausea, vomiting, and leukocytosis were significantly more common in tigecycline patients, whereas hypokalemia was significantly more common in levofloxacin patients. Treatment discontinuation rates due to adverse events were similar between the tigecycline and levofloxacin groups (6.5% vs. 8%), Dr. Dartois said.

NICE, FRANCE — Tigecycline is as effective as levofloxacin in treating patients hospitalized with community-acquired pneumonia, results of a phase III clinical trial suggest.

Tigecycline appeared safe and was effective against the most common respiratory pathogens that have been observed in patients with community-acquired pneumonia.

There was no evidence of resistance to tigecycline in the study, which was conducted by 62 investigators in 22 countries, Dr. Nathalie Dartois said at the 16th European Congress of Clinical Microbiology and Infectious Diseases.

The findings are important in light of the increasing rate of hospitalizations associated with community-acquired pneumonia, and the continued increase in resistance to antibiotics such as penicillin, macrolides, and fluoroquinolones, said Dr. Dartois, of Wyeth Research, Paris; Wyeth Pharmaceuticals Inc. markets tigecycline under the brand name Tygacil and funded the trial.

Levofloxacin, a fluoroquinolone, is sold under the brand name Levaquin.

Tigecycline is a first-in-class glycylcycline that was approved in the United States in June 2005 for treating complicated skin, soft tissue, and intraabdominal infections, and is pending approval in Europe. It has a broad spectrum of activity against gram-positive, gram-negative, anaerobic, atypical, and antibiotic-resistant bacteria, with the exception of Pseudomonas.

Tigecycline's extended postantibiotic effect is probably attributable to its long half-life, which is about 42 hours, Dr. Dartois said.

The study included 428 patients who were hospitalized with community-acquired pneumonia severe enough to require intravenous antibiotic treatment for at least 7 days.

The patients also had fever or hypothermia, new infiltrate seen on chest x-ray within 48 hours of admission, and at least two of the following: cough, purulent sputum, rales, dyspnea, increased white blood cell count, or hypoxemia.

Patients were randomized to tigecycline at an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours, or to levofloxacin 500 mg every 12 or 24 hours.

Coprimary end points of the study were clinical response in 280 clinically evaluable patients and 403 modified intent-to-treat patients assessed 10–21 days after the last dose. Demographics were similar in both treatment groups, and the majority of patients had a Fine pneumonia severity index (PSI) score that put them in risk classes II-IV. About 20% of patients had failed previous antibiotics. Their mean age was 49 years.

Of the 280 clinically evaluable patients, clinical cure was achieved in 128 (89%) of 144 patients in the tigecycline group, and 116 (85%) of 136 patients in the levofloxacin group.

Cure rates by patient PSI scores were 89.5% with tigecycline vs. 87% with levofloxacin in PSI risk class II patients, 85% vs. 83% in risk class III, 91% vs. 83% in risk class IV, and 100% for both agents in risk class V.

In the modified intent-to-treat population, tigecycline cured 170 (84%) of 203 patients and levofloxacin cured 163 (82%) of 200. Cure rates for the two most common isolates at baseline were 96% with tigecycline vs. 92% with levofloxacin for Mycoplasma pneumoniae and 93% vs. 94% for cultured Streptococcus pneumoniae.

Adverse events were reported by 62.5% of patients in the tigecycline group and 47% of patients in the levofloxacin group. Nausea, vomiting, and leukocytosis were significantly more common in tigecycline patients, whereas hypokalemia was significantly more common in levofloxacin patients. Treatment discontinuation rates due to adverse events were similar between the tigecycline and levofloxacin groups (6.5% vs. 8%), Dr. Dartois said.

NICE, FRANCE — A new study suggests that stress hyperglycemia may be an important predictor of morbidity and mortality in nondiabetic patients with sepsis.

The study included 242 nondiabetic patients hospitalized with severe sepsis in three hospitals in southwestern Greece during a 1-year period. Hyperglycemia was defined as an admission or in-hospital fasting glucose level of 126 mg/dL or more, or a random blood glucose level of 200 mg/dL or more on two or more evaluations.

Stress hyperglycemia—a transient elevation of blood glucose levels due to various factors including stress, injury, and surgery—was present in 20% of the patients, Dr. Lydia Leonidou reported at the 16th European Congress on Clinical Microbiology and Infectious Diseases.

Moreover, a significantly higher percentage of septic patients who had stress hyperglycemia died, compared with patients who had normal glucose levels (43.4% vs. 13.2%).

Stress hyperglycemia was not related to a genetic predisposition to diabetes mellitus. Only 6% of hyperglycemic patients had a first-degree relative with diabetes, compared with 11% of normal glycemic patients, reported Dr. Leonidou and her colleagues at the University of Patras (Greece).

Sources of infection in all patients were: respiratory tract 42%, urinary tract 35%, intraabdominal 16%, central nervous system 3%, soft tissue 3%, and endocarditis 1%. Hyperglycemic patients were older than normal glycemic patients, but the difference was not statistically significant (73.4 vs. 65.7 years). There was no significant difference in gender, body mass index, C-reactive protein, blood cultures, and hospitalization days between groups. Hemoglobin A_1c levels were significantly higher among hyperglycemia patients (5.73% vs. 5.44%) but were within the normal range of 4–5.9%.

Patients with stress hyperglycemia had a significantly higher sepsis-related organ failure assessment (SOFA) score than patients with normal glycemia (mean 4.9 vs. 2.9). This finding left some in attendance to question whether stress hyperglycemia caused poor outcomes or was just another surrogate marker like SOFA scores. Lead author Dr. Charalambos Gogos responded, “We believe that hyperglycemia is not [just] a surrogate marker, but something you have to fight in your patients with good glycemic control.”

NICE, FRANCE — A new study suggests that stress hyperglycemia may be an important predictor of morbidity and mortality in nondiabetic patients with sepsis.

The study included 242 nondiabetic patients hospitalized with severe sepsis in three hospitals in southwestern Greece during a 1-year period. Hyperglycemia was defined as an admission or in-hospital fasting glucose level of 126 mg/dL or more, or a random blood glucose level of 200 mg/dL or more on two or more evaluations.

Stress hyperglycemia—a transient elevation of blood glucose levels due to various factors including stress, injury, and surgery—was present in 20% of the patients, Dr. Lydia Leonidou reported at the 16th European Congress on Clinical Microbiology and Infectious Diseases.

Moreover, a significantly higher percentage of septic patients who had stress hyperglycemia died, compared with patients who had normal glucose levels (43.4% vs. 13.2%).

Stress hyperglycemia was not related to a genetic predisposition to diabetes mellitus. Only 6% of hyperglycemic patients had a first-degree relative with diabetes, compared with 11% of normal glycemic patients, reported Dr. Leonidou and her colleagues at the University of Patras (Greece).

Sources of infection in all patients were: respiratory tract 42%, urinary tract 35%, intraabdominal 16%, central nervous system 3%, soft tissue 3%, and endocarditis 1%. Hyperglycemic patients were older than normal glycemic patients, but the difference was not statistically significant (73.4 vs. 65.7 years). There was no significant difference in gender, body mass index, C-reactive protein, blood cultures, and hospitalization days between groups. Hemoglobin A_1c levels were significantly higher among hyperglycemia patients (5.73% vs. 5.44%) but were within the normal range of 4–5.9%.

Patients with stress hyperglycemia had a significantly higher sepsis-related organ failure assessment (SOFA) score than patients with normal glycemia (mean 4.9 vs. 2.9). This finding left some in attendance to question whether stress hyperglycemia caused poor outcomes or was just another surrogate marker like SOFA scores. Lead author Dr. Charalambos Gogos responded, “We believe that hyperglycemia is not [just] a surrogate marker, but something you have to fight in your patients with good glycemic control.”

NICE, FRANCE — A new study suggests that stress hyperglycemia may be an important predictor of morbidity and mortality in nondiabetic patients with sepsis.

The study included 242 nondiabetic patients hospitalized with severe sepsis in three hospitals in southwestern Greece during a 1-year period. Hyperglycemia was defined as an admission or in-hospital fasting glucose level of 126 mg/dL or more, or a random blood glucose level of 200 mg/dL or more on two or more evaluations.

Stress hyperglycemia—a transient elevation of blood glucose levels due to various factors including stress, injury, and surgery—was present in 20% of the patients, Dr. Lydia Leonidou reported at the 16th European Congress on Clinical Microbiology and Infectious Diseases.

Moreover, a significantly higher percentage of septic patients who had stress hyperglycemia died, compared with patients who had normal glucose levels (43.4% vs. 13.2%).

Stress hyperglycemia was not related to a genetic predisposition to diabetes mellitus. Only 6% of hyperglycemic patients had a first-degree relative with diabetes, compared with 11% of normal glycemic patients, reported Dr. Leonidou and her colleagues at the University of Patras (Greece).

Sources of infection in all patients were: respiratory tract 42%, urinary tract 35%, intraabdominal 16%, central nervous system 3%, soft tissue 3%, and endocarditis 1%. Hyperglycemic patients were older than normal glycemic patients, but the difference was not statistically significant (73.4 vs. 65.7 years). There was no significant difference in gender, body mass index, C-reactive protein, blood cultures, and hospitalization days between groups. Hemoglobin A_1c levels were significantly higher among hyperglycemia patients (5.73% vs. 5.44%) but were within the normal range of 4–5.9%.

Patients with stress hyperglycemia had a significantly higher sepsis-related organ failure assessment (SOFA) score than patients with normal glycemia (mean 4.9 vs. 2.9). This finding left some in attendance to question whether stress hyperglycemia caused poor outcomes or was just another surrogate marker like SOFA scores. Lead author Dr. Charalambos Gogos responded, “We believe that hyperglycemia is not [just] a surrogate marker, but something you have to fight in your patients with good glycemic control.”