Doug Brunk

DANA POINT, CALIF. – Patients with melasma who underwent treatment with a new low-energy and low-density nonablative fractional 1,927-nm diode laser experienced significant reduction of hyperpigmentation with limited side effects, a single-center study demonstrated.

At a meeting sponsored by SkinCare Physicians and Northwestern University, Dr. Roy G. Geronemus discussed his experience treating patients with the FDA-cleared technology, which is known as the Clear + Brilliant Permea.

Dr. Geronemus of the Laser and Skin Surgery Center of New York noted that existing laser treatments have so far failed to yield a consistent and long-term reduction in pigmentation, especially in patients with darker skin types. "Many current [laser] treatments for melasma make the condition worse," he said "What we ideally need is something that will be helpful, will not make it worse, and that can be repeated, because [melasma] probably will recur over time."

In an ongoing prospective study, Dr. Geronemus and his associates evaluated the 1,927-nm diode laser in melasma patients with a hunch that it would improve pigmentation and appearance with an improved safety profile and overall treatment outcomes. They enrolled patients aged 18-65 years with Fitzpatrick skin types I-VI who had clinical evidence of melasma or postinflammatory hyperpigmentation. They excluded patients who were either pregnant, breast-feeding, contemplating pregnancy, or not using effective means of birth control, as well as those known to be hypersensitive to light exposure and those with a history of melanoma or nonmelanoma skin cancer, keloidal scarring, immunosuppression, or immune deficiency disorder. Images were taken at baseline, prior to each treatment, and at follow-up using the Canfield VISIA complexion analysis system.

Up to six treatments were performed every 2 weeks, Dr. Geronemus said, with spot sizes of 100-180 mcm, energy of 5 mJ, 5-7.5% treatment coverage, and an average of 4-12 passes.

The researchers asked patients to rate their pain after each treatment, as well as their overall improvement in pigmentation. Pain was assessed on an 11-point scale, with 0 being none and 10 being "intolerable." Pigmentation improvement was measured on a 5-point scale, with 0 being none, 1 being mild (1-25%), 2 being moderate (26-50%), 3 being marked (51-75%), and 4 being very significant (76-100%). At the final 3-month visit, patients were asked to rate their overall satisfaction with the treatment on a 5-point scale ranging from very dissatisfied (1) to very satisfied (5).

Dr. Geronemus presented results from 14 patients who had completed 3-month follow-up visits. These 14 women included 10 with melasma and 4 with postinflammatory hyperpigmentation. The mean age of the patients was 42 years, and 9 had Fitzpatrick skin types I-III.

The patients rated their pain as 3.25 out of 10, their overall pigment improvement as 3 out of 4, and their overall satisfaction with the procedure as a 4.33 out of 5, Dr. Geronemus reported. "This is often technique sensitive," he said of the procedure. "I’ll have physicians call me up and say, ‘I’m not getting any results.’ I think you need 10-12 passes to get the [optimal] results."

The most common side effect was erythema, which typically resolved within 1 day. Though the device is effective as monotherapy, Dr. Geronemus pointed out that it is "ideally suited for combination therapy with a mild hydroquinone."

Dr. Geronemus disclosed that he serves on the medical advisory boards for Zeltiq, Syneron/Candela, and Cynosure. He also serves as an investigator for numerous device and pharmaceutical companies, and he holds stock in Zeltiq and OnLight Sciences.

dbrunk@frontlinemedcom.com

DANA POINT, CALIF. – Patients with melasma who underwent treatment with a new low-energy and low-density nonablative fractional 1,927-nm diode laser experienced significant reduction of hyperpigmentation with limited side effects, a single-center study demonstrated.

At a meeting sponsored by SkinCare Physicians and Northwestern University, Dr. Roy G. Geronemus discussed his experience treating patients with the FDA-cleared technology, which is known as the Clear + Brilliant Permea.

Dr. Geronemus of the Laser and Skin Surgery Center of New York noted that existing laser treatments have so far failed to yield a consistent and long-term reduction in pigmentation, especially in patients with darker skin types. "Many current [laser] treatments for melasma make the condition worse," he said "What we ideally need is something that will be helpful, will not make it worse, and that can be repeated, because [melasma] probably will recur over time."

In an ongoing prospective study, Dr. Geronemus and his associates evaluated the 1,927-nm diode laser in melasma patients with a hunch that it would improve pigmentation and appearance with an improved safety profile and overall treatment outcomes. They enrolled patients aged 18-65 years with Fitzpatrick skin types I-VI who had clinical evidence of melasma or postinflammatory hyperpigmentation. They excluded patients who were either pregnant, breast-feeding, contemplating pregnancy, or not using effective means of birth control, as well as those known to be hypersensitive to light exposure and those with a history of melanoma or nonmelanoma skin cancer, keloidal scarring, immunosuppression, or immune deficiency disorder. Images were taken at baseline, prior to each treatment, and at follow-up using the Canfield VISIA complexion analysis system.

Up to six treatments were performed every 2 weeks, Dr. Geronemus said, with spot sizes of 100-180 mcm, energy of 5 mJ, 5-7.5% treatment coverage, and an average of 4-12 passes.

The researchers asked patients to rate their pain after each treatment, as well as their overall improvement in pigmentation. Pain was assessed on an 11-point scale, with 0 being none and 10 being "intolerable." Pigmentation improvement was measured on a 5-point scale, with 0 being none, 1 being mild (1-25%), 2 being moderate (26-50%), 3 being marked (51-75%), and 4 being very significant (76-100%). At the final 3-month visit, patients were asked to rate their overall satisfaction with the treatment on a 5-point scale ranging from very dissatisfied (1) to very satisfied (5).

Dr. Geronemus presented results from 14 patients who had completed 3-month follow-up visits. These 14 women included 10 with melasma and 4 with postinflammatory hyperpigmentation. The mean age of the patients was 42 years, and 9 had Fitzpatrick skin types I-III.

The patients rated their pain as 3.25 out of 10, their overall pigment improvement as 3 out of 4, and their overall satisfaction with the procedure as a 4.33 out of 5, Dr. Geronemus reported. "This is often technique sensitive," he said of the procedure. "I’ll have physicians call me up and say, ‘I’m not getting any results.’ I think you need 10-12 passes to get the [optimal] results."

The most common side effect was erythema, which typically resolved within 1 day. Though the device is effective as monotherapy, Dr. Geronemus pointed out that it is "ideally suited for combination therapy with a mild hydroquinone."

Dr. Geronemus disclosed that he serves on the medical advisory boards for Zeltiq, Syneron/Candela, and Cynosure. He also serves as an investigator for numerous device and pharmaceutical companies, and he holds stock in Zeltiq and OnLight Sciences.

dbrunk@frontlinemedcom.com

DANA POINT, CALIF. – Patients with melasma who underwent treatment with a new low-energy and low-density nonablative fractional 1,927-nm diode laser experienced significant reduction of hyperpigmentation with limited side effects, a single-center study demonstrated.

At a meeting sponsored by SkinCare Physicians and Northwestern University, Dr. Roy G. Geronemus discussed his experience treating patients with the FDA-cleared technology, which is known as the Clear + Brilliant Permea.

Dr. Geronemus of the Laser and Skin Surgery Center of New York noted that existing laser treatments have so far failed to yield a consistent and long-term reduction in pigmentation, especially in patients with darker skin types. "Many current [laser] treatments for melasma make the condition worse," he said "What we ideally need is something that will be helpful, will not make it worse, and that can be repeated, because [melasma] probably will recur over time."

In an ongoing prospective study, Dr. Geronemus and his associates evaluated the 1,927-nm diode laser in melasma patients with a hunch that it would improve pigmentation and appearance with an improved safety profile and overall treatment outcomes. They enrolled patients aged 18-65 years with Fitzpatrick skin types I-VI who had clinical evidence of melasma or postinflammatory hyperpigmentation. They excluded patients who were either pregnant, breast-feeding, contemplating pregnancy, or not using effective means of birth control, as well as those known to be hypersensitive to light exposure and those with a history of melanoma or nonmelanoma skin cancer, keloidal scarring, immunosuppression, or immune deficiency disorder. Images were taken at baseline, prior to each treatment, and at follow-up using the Canfield VISIA complexion analysis system.

Up to six treatments were performed every 2 weeks, Dr. Geronemus said, with spot sizes of 100-180 mcm, energy of 5 mJ, 5-7.5% treatment coverage, and an average of 4-12 passes.

The researchers asked patients to rate their pain after each treatment, as well as their overall improvement in pigmentation. Pain was assessed on an 11-point scale, with 0 being none and 10 being "intolerable." Pigmentation improvement was measured on a 5-point scale, with 0 being none, 1 being mild (1-25%), 2 being moderate (26-50%), 3 being marked (51-75%), and 4 being very significant (76-100%). At the final 3-month visit, patients were asked to rate their overall satisfaction with the treatment on a 5-point scale ranging from very dissatisfied (1) to very satisfied (5).

Dr. Geronemus presented results from 14 patients who had completed 3-month follow-up visits. These 14 women included 10 with melasma and 4 with postinflammatory hyperpigmentation. The mean age of the patients was 42 years, and 9 had Fitzpatrick skin types I-III.

The patients rated their pain as 3.25 out of 10, their overall pigment improvement as 3 out of 4, and their overall satisfaction with the procedure as a 4.33 out of 5, Dr. Geronemus reported. "This is often technique sensitive," he said of the procedure. "I’ll have physicians call me up and say, ‘I’m not getting any results.’ I think you need 10-12 passes to get the [optimal] results."

The most common side effect was erythema, which typically resolved within 1 day. Though the device is effective as monotherapy, Dr. Geronemus pointed out that it is "ideally suited for combination therapy with a mild hydroquinone."

Dr. Geronemus disclosed that he serves on the medical advisory boards for Zeltiq, Syneron/Candela, and Cynosure. He also serves as an investigator for numerous device and pharmaceutical companies, and he holds stock in Zeltiq and OnLight Sciences.

dbrunk@frontlinemedcom.com

DENVER – Once-weekly intravenous dalbavancin was effective against acute bacterial skin and skin structure infections, and not inferior to twice-daily IV vancomycin followed by oral linezolid, results from a randomized, double-blind study showed.

Dalbavancin is an investigational lipoglycopeptide being developed by Branford, Conn.–based Durata Therapeutics for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible gram-positive microorganisms.

ABSSSIs are common and are among the most frequent indications for antibiotic therapy and hospitalization of adults in the United States today, Dr. Helen W. Boucher said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented. ABSSSIs are most often caused by Staphylococcus aureus and streptococci.

"Increasing antimicrobial resistance presents a particular treatment challenge and limits options available for the treatment of these infections," said Dr. Boucher of Tufts Medical Center, Boston. "Treatment of ABSSSI can involve substantial costs in terms of direct medical costs and time away from work or school. The pharmacokinetics of dalbavancin allow once weekly dosing, which is more convenient for patients and increases adherence to therapy. It may allow patients to be treated without being admitted to the hospital or allow for shorter hospital stays," she said.

In the study, known as DISCOVER 1, a total of 573 patients with severe ABSSSI were randomized to receive either dalbavancin 1 g IV over 30 minutes on day 1 followed by 500 mg IV on day 8; or vancomycin 1 g or 15 mg/kg IV every 12 hours for at least 3 days, with an option to switch to oral linezolid 600 mg every 12 hours.

The primary endpoint for regulatory review in the United States was combined factors known as the early response endpoint – cessation of the spread of the erythema of the infection, and the absence of fever at 48-72 hours after treatment initiation.

Overall, 83.3% of patients in the dalbavancin group achieved the early response endpoint compared with 81.8% of patients in the vancomycin group, for a difference of 1.5%. The most commonly reported adverse events in the dalbavancin and vancomycin/linezolid groups were nausea (4.2% vs. 4.6%, respectively), diarrhea (1.4% vs. 3.9%), headache (4.9% vs. 4.9%), pruritus (0.4% vs. 3.9%), hypertension (2.5% vs. 2.5%), rash (2.1% vs. 2.1%), and asthenia (0.4% vs. 2.1%).

Dr. Boucher, director of the infectious diseases fellowship program and an associate professor of medicine at Tufts, characterized the findings as especially impressive, considering that patients in DISCOVER 1 had very large skin lesions (a median area of about 333 cm²), and high frequencies of fever (85%) and systemic inflammatory response syndrome (61%), which is a marker of very severe illness. "It means that the drug stood up to very ill patients," she said.

She acknowledged certain limitations of the study, including the fact that adherence to twice-daily therapy with vancomycin/linezolid "may not be as high in a real-world setting as that seen in a closely monitored clinical trial setting."

Dr. Boucher disclosed that she is a scientific adviser for Durata Therapeutics, which sponsored the study, and has ties to numerous other pharmaceutical companies.

dbrunk@frontlinemedcom.com

DENVER – Once-weekly intravenous dalbavancin was effective against acute bacterial skin and skin structure infections, and not inferior to twice-daily IV vancomycin followed by oral linezolid, results from a randomized, double-blind study showed.

Dalbavancin is an investigational lipoglycopeptide being developed by Branford, Conn.–based Durata Therapeutics for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible gram-positive microorganisms.

ABSSSIs are common and are among the most frequent indications for antibiotic therapy and hospitalization of adults in the United States today, Dr. Helen W. Boucher said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented. ABSSSIs are most often caused by Staphylococcus aureus and streptococci.

"Increasing antimicrobial resistance presents a particular treatment challenge and limits options available for the treatment of these infections," said Dr. Boucher of Tufts Medical Center, Boston. "Treatment of ABSSSI can involve substantial costs in terms of direct medical costs and time away from work or school. The pharmacokinetics of dalbavancin allow once weekly dosing, which is more convenient for patients and increases adherence to therapy. It may allow patients to be treated without being admitted to the hospital or allow for shorter hospital stays," she said.

In the study, known as DISCOVER 1, a total of 573 patients with severe ABSSSI were randomized to receive either dalbavancin 1 g IV over 30 minutes on day 1 followed by 500 mg IV on day 8; or vancomycin 1 g or 15 mg/kg IV every 12 hours for at least 3 days, with an option to switch to oral linezolid 600 mg every 12 hours.

The primary endpoint for regulatory review in the United States was combined factors known as the early response endpoint – cessation of the spread of the erythema of the infection, and the absence of fever at 48-72 hours after treatment initiation.

Overall, 83.3% of patients in the dalbavancin group achieved the early response endpoint compared with 81.8% of patients in the vancomycin group, for a difference of 1.5%. The most commonly reported adverse events in the dalbavancin and vancomycin/linezolid groups were nausea (4.2% vs. 4.6%, respectively), diarrhea (1.4% vs. 3.9%), headache (4.9% vs. 4.9%), pruritus (0.4% vs. 3.9%), hypertension (2.5% vs. 2.5%), rash (2.1% vs. 2.1%), and asthenia (0.4% vs. 2.1%).

Dr. Boucher, director of the infectious diseases fellowship program and an associate professor of medicine at Tufts, characterized the findings as especially impressive, considering that patients in DISCOVER 1 had very large skin lesions (a median area of about 333 cm²), and high frequencies of fever (85%) and systemic inflammatory response syndrome (61%), which is a marker of very severe illness. "It means that the drug stood up to very ill patients," she said.

She acknowledged certain limitations of the study, including the fact that adherence to twice-daily therapy with vancomycin/linezolid "may not be as high in a real-world setting as that seen in a closely monitored clinical trial setting."

Dr. Boucher disclosed that she is a scientific adviser for Durata Therapeutics, which sponsored the study, and has ties to numerous other pharmaceutical companies.

dbrunk@frontlinemedcom.com

DENVER – Once-weekly intravenous dalbavancin was effective against acute bacterial skin and skin structure infections, and not inferior to twice-daily IV vancomycin followed by oral linezolid, results from a randomized, double-blind study showed.

Dalbavancin is an investigational lipoglycopeptide being developed by Branford, Conn.–based Durata Therapeutics for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible gram-positive microorganisms.

ABSSSIs are common and are among the most frequent indications for antibiotic therapy and hospitalization of adults in the United States today, Dr. Helen W. Boucher said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented. ABSSSIs are most often caused by Staphylococcus aureus and streptococci.

"Increasing antimicrobial resistance presents a particular treatment challenge and limits options available for the treatment of these infections," said Dr. Boucher of Tufts Medical Center, Boston. "Treatment of ABSSSI can involve substantial costs in terms of direct medical costs and time away from work or school. The pharmacokinetics of dalbavancin allow once weekly dosing, which is more convenient for patients and increases adherence to therapy. It may allow patients to be treated without being admitted to the hospital or allow for shorter hospital stays," she said.

In the study, known as DISCOVER 1, a total of 573 patients with severe ABSSSI were randomized to receive either dalbavancin 1 g IV over 30 minutes on day 1 followed by 500 mg IV on day 8; or vancomycin 1 g or 15 mg/kg IV every 12 hours for at least 3 days, with an option to switch to oral linezolid 600 mg every 12 hours.

The primary endpoint for regulatory review in the United States was combined factors known as the early response endpoint – cessation of the spread of the erythema of the infection, and the absence of fever at 48-72 hours after treatment initiation.

Overall, 83.3% of patients in the dalbavancin group achieved the early response endpoint compared with 81.8% of patients in the vancomycin group, for a difference of 1.5%. The most commonly reported adverse events in the dalbavancin and vancomycin/linezolid groups were nausea (4.2% vs. 4.6%, respectively), diarrhea (1.4% vs. 3.9%), headache (4.9% vs. 4.9%), pruritus (0.4% vs. 3.9%), hypertension (2.5% vs. 2.5%), rash (2.1% vs. 2.1%), and asthenia (0.4% vs. 2.1%).

Dr. Boucher, director of the infectious diseases fellowship program and an associate professor of medicine at Tufts, characterized the findings as especially impressive, considering that patients in DISCOVER 1 had very large skin lesions (a median area of about 333 cm²), and high frequencies of fever (85%) and systemic inflammatory response syndrome (61%), which is a marker of very severe illness. "It means that the drug stood up to very ill patients," she said.

She acknowledged certain limitations of the study, including the fact that adherence to twice-daily therapy with vancomycin/linezolid "may not be as high in a real-world setting as that seen in a closely monitored clinical trial setting."

Dr. Boucher disclosed that she is a scientific adviser for Durata Therapeutics, which sponsored the study, and has ties to numerous other pharmaceutical companies.

dbrunk@frontlinemedcom.com

Nearly half of patients with systemic lupus erythematosus had at least one mood or anxiety disorder, and slightly more than one-third had at least one personality disorder, the results from a small cross-sectional study demonstrated.

"When our results, including the onset time of mood or anxiety disorders, are considered, these disorders seem to be secondary to the severity of lupus rather than play a primary role in the exacerbation of SLE," Turkish researchers led by Dr. Faruk Uguz wrote. "However, it is unclear whether there is a biological basis of this condition or psychological reaction to the severity of SLE."

Dr. Uguz, a psychiatrist with the University of Necmettin Erbakan, Konya, Turkey, and his associates evaluated 45 consecutive patients with SLE who were admitted to the university’s rheumatology outpatient clinic. They also included a control group of 60 hospital personnel and their relatives who were matched for the sociodemographic characteristics of the SLE patients.

Exclusion criteria included illiteracy, cognitive incompetence, a history of schizophrenia or related psychotic disorders, a history of neurologic diseases or severe neurologic manifestations of SLE, concomitant serious medical illnesses such as uncontrolled endocrine abnormalities, cardiovascular disease, movement disorder, and the use of psychotropic medication within the last 4 weeks.

The researchers used the American College of Rheumatology revised criteria for SLE to diagnose SLE, the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition/Clinical Version to diagnose mood and anxiety disorders, and the Structured Clinical Interview for DSM, Revised Third Edition to diagnose personality disorders (Compr. Psychiatry 2013;54:341-5). Psychiatric interviews were conducted by psychiatrists with at least 4 years of experience with psychiatric disorders and diagnostic instruments.

The mean age of the study participants was 40 years. Most (91%) were female, married (85%), and unemployed (88%). The disease duration was a mean of 67 months in the patient group. Dr. Uguz and his colleagues reported that 21 people in the patient group (47%) had at least one mood or anxiety disorder and 16 (36%) had any personality disorder. By contrast, 10 people in the control group (17%) had at least one mood or anxiety disorder and 7 (12%) had any personality disorder.

Among SLE patients, the most common psychiatric disorders were major depression (22%) and generalized anxiety disorder (16%). The conditions affected 5% and 3% of control subjects, respectively.

"Being of a cross-sectional nature, the present study is limited by an insufficiency to indicate whether the evaluated Axis I or Axis II psychiatric disorders have causal relevance to SLE," the researchers wrote. "It is unclear whether Axis I disorders are a contributing factor that may exacerbate SLE, or are secondary to the development of a more active SLE."

Another limitation of the study is its small sample size, they said, as well as its failure to determine whether a patient had a family history of mental disorders. "Further controlled studies with larger sample sizes should be conducted to investigate long-term effects of psychiatric disorders and their treatments in the course of SLE," the investigators concluded.

dbrunk@frontlinemedcom.com

Nearly half of patients with systemic lupus erythematosus had at least one mood or anxiety disorder, and slightly more than one-third had at least one personality disorder, the results from a small cross-sectional study demonstrated.

"When our results, including the onset time of mood or anxiety disorders, are considered, these disorders seem to be secondary to the severity of lupus rather than play a primary role in the exacerbation of SLE," Turkish researchers led by Dr. Faruk Uguz wrote. "However, it is unclear whether there is a biological basis of this condition or psychological reaction to the severity of SLE."

Dr. Uguz, a psychiatrist with the University of Necmettin Erbakan, Konya, Turkey, and his associates evaluated 45 consecutive patients with SLE who were admitted to the university’s rheumatology outpatient clinic. They also included a control group of 60 hospital personnel and their relatives who were matched for the sociodemographic characteristics of the SLE patients.

Exclusion criteria included illiteracy, cognitive incompetence, a history of schizophrenia or related psychotic disorders, a history of neurologic diseases or severe neurologic manifestations of SLE, concomitant serious medical illnesses such as uncontrolled endocrine abnormalities, cardiovascular disease, movement disorder, and the use of psychotropic medication within the last 4 weeks.

The researchers used the American College of Rheumatology revised criteria for SLE to diagnose SLE, the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition/Clinical Version to diagnose mood and anxiety disorders, and the Structured Clinical Interview for DSM, Revised Third Edition to diagnose personality disorders (Compr. Psychiatry 2013;54:341-5). Psychiatric interviews were conducted by psychiatrists with at least 4 years of experience with psychiatric disorders and diagnostic instruments.

The mean age of the study participants was 40 years. Most (91%) were female, married (85%), and unemployed (88%). The disease duration was a mean of 67 months in the patient group. Dr. Uguz and his colleagues reported that 21 people in the patient group (47%) had at least one mood or anxiety disorder and 16 (36%) had any personality disorder. By contrast, 10 people in the control group (17%) had at least one mood or anxiety disorder and 7 (12%) had any personality disorder.

Among SLE patients, the most common psychiatric disorders were major depression (22%) and generalized anxiety disorder (16%). The conditions affected 5% and 3% of control subjects, respectively.

"Being of a cross-sectional nature, the present study is limited by an insufficiency to indicate whether the evaluated Axis I or Axis II psychiatric disorders have causal relevance to SLE," the researchers wrote. "It is unclear whether Axis I disorders are a contributing factor that may exacerbate SLE, or are secondary to the development of a more active SLE."

Another limitation of the study is its small sample size, they said, as well as its failure to determine whether a patient had a family history of mental disorders. "Further controlled studies with larger sample sizes should be conducted to investigate long-term effects of psychiatric disorders and their treatments in the course of SLE," the investigators concluded.

dbrunk@frontlinemedcom.com

Nearly half of patients with systemic lupus erythematosus had at least one mood or anxiety disorder, and slightly more than one-third had at least one personality disorder, the results from a small cross-sectional study demonstrated.

"When our results, including the onset time of mood or anxiety disorders, are considered, these disorders seem to be secondary to the severity of lupus rather than play a primary role in the exacerbation of SLE," Turkish researchers led by Dr. Faruk Uguz wrote. "However, it is unclear whether there is a biological basis of this condition or psychological reaction to the severity of SLE."

Dr. Uguz, a psychiatrist with the University of Necmettin Erbakan, Konya, Turkey, and his associates evaluated 45 consecutive patients with SLE who were admitted to the university’s rheumatology outpatient clinic. They also included a control group of 60 hospital personnel and their relatives who were matched for the sociodemographic characteristics of the SLE patients.

Exclusion criteria included illiteracy, cognitive incompetence, a history of schizophrenia or related psychotic disorders, a history of neurologic diseases or severe neurologic manifestations of SLE, concomitant serious medical illnesses such as uncontrolled endocrine abnormalities, cardiovascular disease, movement disorder, and the use of psychotropic medication within the last 4 weeks.

The researchers used the American College of Rheumatology revised criteria for SLE to diagnose SLE, the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition/Clinical Version to diagnose mood and anxiety disorders, and the Structured Clinical Interview for DSM, Revised Third Edition to diagnose personality disorders (Compr. Psychiatry 2013;54:341-5). Psychiatric interviews were conducted by psychiatrists with at least 4 years of experience with psychiatric disorders and diagnostic instruments.

The mean age of the study participants was 40 years. Most (91%) were female, married (85%), and unemployed (88%). The disease duration was a mean of 67 months in the patient group. Dr. Uguz and his colleagues reported that 21 people in the patient group (47%) had at least one mood or anxiety disorder and 16 (36%) had any personality disorder. By contrast, 10 people in the control group (17%) had at least one mood or anxiety disorder and 7 (12%) had any personality disorder.

Among SLE patients, the most common psychiatric disorders were major depression (22%) and generalized anxiety disorder (16%). The conditions affected 5% and 3% of control subjects, respectively.

"Being of a cross-sectional nature, the present study is limited by an insufficiency to indicate whether the evaluated Axis I or Axis II psychiatric disorders have causal relevance to SLE," the researchers wrote. "It is unclear whether Axis I disorders are a contributing factor that may exacerbate SLE, or are secondary to the development of a more active SLE."

Another limitation of the study is its small sample size, they said, as well as its failure to determine whether a patient had a family history of mental disorders. "Further controlled studies with larger sample sizes should be conducted to investigate long-term effects of psychiatric disorders and their treatments in the course of SLE," the investigators concluded.

dbrunk@frontlinemedcom.com

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

dbrunk@frontlinemedcom.com

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

dbrunk@frontlinemedcom.com

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

dbrunk@frontlinemedcom.com

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

dbrunk@frontlinemedcom.com

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

dbrunk@frontlinemedcom.com

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

dbrunk@frontlinemedcom.com

DENVER – A single intravenous 1,200-mg dose of the investigational agent oritavancin was noninferior to 7-10 days of intravenous vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, results from a multicenter trial showed.

Oritavancin is a novel lipoglycopeptide being developed by Parsippany, N.J.–based The Medicines Company for the treatment of serious gram-positive infections. If it earns Food and Drug Administration approval, oritavancin "may contribute to improving the efficiency of the pathway of care for how we clinicians treat ABSSSIs," Dr. G. Ralph Corey, lead study investigator, said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"It has the potential to provide a single-dose alternative to multidose therapies for the treatment of ABSSSI. Administering the entire course of therapy upfront ensures 100% compliance," said Dr. Corey of Duke University, Durham, N.C.

In a double-blind, phase III trial known as SOLO-1, sponsored by The Medicines Company and carried out at 46 centers worldwide, Dr. Corey and his associates randomized 475 patients with ABSSSIs to a single 1,200-mg dose of IV oritavancin and 479 patients with ABSSSIs to 7-10 days of twice-daily IV vancomycin.

Three efficacy endpoints were tested for noninferiority: the primary composite endpoint at 48-72 hours, which comprised cessation of spreading or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic; the investigator-assessed clinical cure 7-14 days after end of treatment; and at a reduction of at least 20% in lesion area at 48-72 hours.

The researchers found that more patients in the oritavancin group than in the vancomycin group achieved the primary composite endpoint (82.3% vs. 78.9%, respectively), and at least a 20% reduction in the lesion area (86.9% vs. 82.9%). The percentage of patients who achieved investigator-assessed clinical cure was essentially the same between the two groups (79.6% vs. 80%).

"It was well-tolerated, with a safety profile similar to vancomycin," said Dr. Corey. "The most frequently reported adverse events were nausea, headache, vomiting and diarrhea."

Dr. Corey was impressed by oritavancin’s quick response "and the increase in response rate at the early clinical evaluation endpoint – 48-72 hours after infusion as measured in the primary efficacy endpoint," he said. "The results in MRSA patients were found to be particularly strong in subgroup analyses and warrant additional study."

Dr. Corey acknowledged certain limitations of SOLO-1, including the fact that the double-blind nature of the infusions "created a limitation in measuring the ability to discharge a patient from the hospital earlier with single-dose treatment," he said. "This can be modeled, but warrants additional study in the real-world setting. Moreover, I think this trial has actually inspired additional new research opportunities," he added. "There are other, potentially more severe indications that oritavancin could cover, and I’m excited to explore further studies on this drug."

According to information from The Medicines Company, the purpose of SOLO-1 was to support the filing of a New Drug Application in the United States as well as a Marketing Authorization Application in Europe.

Dr. Corey disclosed that he is a consultant, scientific adviser, and investigator for The Medicines Company. He serves in similar capacities for numerous other pharmaceutical companies, including Pfizer and Merck.

dbrunk@frontlinemedcom.com

DENVER – A single intravenous 1,200-mg dose of the investigational agent oritavancin was noninferior to 7-10 days of intravenous vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, results from a multicenter trial showed.

Oritavancin is a novel lipoglycopeptide being developed by Parsippany, N.J.–based The Medicines Company for the treatment of serious gram-positive infections. If it earns Food and Drug Administration approval, oritavancin "may contribute to improving the efficiency of the pathway of care for how we clinicians treat ABSSSIs," Dr. G. Ralph Corey, lead study investigator, said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"It has the potential to provide a single-dose alternative to multidose therapies for the treatment of ABSSSI. Administering the entire course of therapy upfront ensures 100% compliance," said Dr. Corey of Duke University, Durham, N.C.

In a double-blind, phase III trial known as SOLO-1, sponsored by The Medicines Company and carried out at 46 centers worldwide, Dr. Corey and his associates randomized 475 patients with ABSSSIs to a single 1,200-mg dose of IV oritavancin and 479 patients with ABSSSIs to 7-10 days of twice-daily IV vancomycin.

Three efficacy endpoints were tested for noninferiority: the primary composite endpoint at 48-72 hours, which comprised cessation of spreading or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic; the investigator-assessed clinical cure 7-14 days after end of treatment; and at a reduction of at least 20% in lesion area at 48-72 hours.

The researchers found that more patients in the oritavancin group than in the vancomycin group achieved the primary composite endpoint (82.3% vs. 78.9%, respectively), and at least a 20% reduction in the lesion area (86.9% vs. 82.9%). The percentage of patients who achieved investigator-assessed clinical cure was essentially the same between the two groups (79.6% vs. 80%).

"It was well-tolerated, with a safety profile similar to vancomycin," said Dr. Corey. "The most frequently reported adverse events were nausea, headache, vomiting and diarrhea."

Dr. Corey was impressed by oritavancin’s quick response "and the increase in response rate at the early clinical evaluation endpoint – 48-72 hours after infusion as measured in the primary efficacy endpoint," he said. "The results in MRSA patients were found to be particularly strong in subgroup analyses and warrant additional study."

Dr. Corey acknowledged certain limitations of SOLO-1, including the fact that the double-blind nature of the infusions "created a limitation in measuring the ability to discharge a patient from the hospital earlier with single-dose treatment," he said. "This can be modeled, but warrants additional study in the real-world setting. Moreover, I think this trial has actually inspired additional new research opportunities," he added. "There are other, potentially more severe indications that oritavancin could cover, and I’m excited to explore further studies on this drug."

According to information from The Medicines Company, the purpose of SOLO-1 was to support the filing of a New Drug Application in the United States as well as a Marketing Authorization Application in Europe.

Dr. Corey disclosed that he is a consultant, scientific adviser, and investigator for The Medicines Company. He serves in similar capacities for numerous other pharmaceutical companies, including Pfizer and Merck.

dbrunk@frontlinemedcom.com

DENVER – A single intravenous 1,200-mg dose of the investigational agent oritavancin was noninferior to 7-10 days of intravenous vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, results from a multicenter trial showed.

Oritavancin is a novel lipoglycopeptide being developed by Parsippany, N.J.–based The Medicines Company for the treatment of serious gram-positive infections. If it earns Food and Drug Administration approval, oritavancin "may contribute to improving the efficiency of the pathway of care for how we clinicians treat ABSSSIs," Dr. G. Ralph Corey, lead study investigator, said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"It has the potential to provide a single-dose alternative to multidose therapies for the treatment of ABSSSI. Administering the entire course of therapy upfront ensures 100% compliance," said Dr. Corey of Duke University, Durham, N.C.

In a double-blind, phase III trial known as SOLO-1, sponsored by The Medicines Company and carried out at 46 centers worldwide, Dr. Corey and his associates randomized 475 patients with ABSSSIs to a single 1,200-mg dose of IV oritavancin and 479 patients with ABSSSIs to 7-10 days of twice-daily IV vancomycin.

Three efficacy endpoints were tested for noninferiority: the primary composite endpoint at 48-72 hours, which comprised cessation of spreading or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic; the investigator-assessed clinical cure 7-14 days after end of treatment; and at a reduction of at least 20% in lesion area at 48-72 hours.

The researchers found that more patients in the oritavancin group than in the vancomycin group achieved the primary composite endpoint (82.3% vs. 78.9%, respectively), and at least a 20% reduction in the lesion area (86.9% vs. 82.9%). The percentage of patients who achieved investigator-assessed clinical cure was essentially the same between the two groups (79.6% vs. 80%).

"It was well-tolerated, with a safety profile similar to vancomycin," said Dr. Corey. "The most frequently reported adverse events were nausea, headache, vomiting and diarrhea."

Dr. Corey was impressed by oritavancin’s quick response "and the increase in response rate at the early clinical evaluation endpoint – 48-72 hours after infusion as measured in the primary efficacy endpoint," he said. "The results in MRSA patients were found to be particularly strong in subgroup analyses and warrant additional study."

Dr. Corey acknowledged certain limitations of SOLO-1, including the fact that the double-blind nature of the infusions "created a limitation in measuring the ability to discharge a patient from the hospital earlier with single-dose treatment," he said. "This can be modeled, but warrants additional study in the real-world setting. Moreover, I think this trial has actually inspired additional new research opportunities," he added. "There are other, potentially more severe indications that oritavancin could cover, and I’m excited to explore further studies on this drug."

According to information from The Medicines Company, the purpose of SOLO-1 was to support the filing of a New Drug Application in the United States as well as a Marketing Authorization Application in Europe.

Dr. Corey disclosed that he is a consultant, scientific adviser, and investigator for The Medicines Company. He serves in similar capacities for numerous other pharmaceutical companies, including Pfizer and Merck.

dbrunk@frontlinemedcom.com

DENVER – A novel breathalyzerlike test detected fungal gas metabolites in the breath of immunocompromised patients with suspected invasive aspergillosis, with excellent sensitivity and specificity, a single-center study demonstrated.

"We envision this work can be adapted to a rapid, noninvasive point-of-care detection system for real-time surveillance of patient breath for the emergence of aspergillosis and potentially for the diagnosis of lung infections caused by other fungal and bacterial pathogens," Dr. Sophia Koo said in an interview prior to a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"An urgent need" exists for better diagnostic tests for invasive aspergillosis, a life-threatening fungal pneumonia in immunocompromised patients, explained Dr. Koo of Harvard Medical School, Boston. Current diagnostic tests – respiratory tract cultures, serum and bronchoalveolar lavage for fungal antigen testing, and nucleic acid detection assays – "have significant limitations in their sensitivity and specificity, and the turnaround time of these assays in clinical practice is often days," she said.

Dr. Koo and her colleagues developed a new method to detect volatile fungal metabolites directly in patient breath. First, they defined the fungal volatile metabolite profile of Aspergillus fumigatus, the most common cause of invasive aspergillosis, in in vitro culture. Next, they used gas chromatography–mass spectrometry to detect those metabolites in the breath of 54 immunocompromised patients with suspected invasive aspergillosis pneumonia. Of those 54 patients, 29 ultimately had invasive aspergillosis, and 25 had other causes of pneumonia.

The breathalyzerlike test correctly identified 27 of 29 patients with invasive aspergillosis and 24 of 25 patients without invasive aspergillosis, for an overall diagnostic sensitivity of 93% and a diagnostic specificity of 96%.

"We were a bit surprised by how clearly we were able to discriminate patients with invasive aspergillosis from patients with other pneumonias using this approach," Dr. Koo noted. "When we made our initial plot of breath fungal volatile metabolites, clustered by patients with and without invasive aspergillosis, there was a clear line demarcating the two groups. We expected some differences in the fungal volatile metabolite profile in vitro and in vivo, with the overlay of the host-pathogen interaction, and we did indeed see some fungal metabolites in vivo that we did not see in any of our in vitro experiments."

While Dr. Koo described gas chromatography–mass spectrometry as "labor intensive," she characterized the findings of the current study as "easily translatable to a point of care platform for the detection of these fungal breath metabolites and potentially the diagnosis of other bacterial and fungal pneumonias at the bedside."

Dr. Koo acknowledged certain limitations of the study, including its single-center design and the fact that it will require validation in a larger cohort of patients.

The National Institutes of Health and the Harvard Catalyst/the Harvard Clinical and Translational Science Center Pilot Grant Program supported the study. The authors stated that they have no relevant financial conflicts.

dbrunk@frontlinemedcom.com

DENVER – A novel breathalyzerlike test detected fungal gas metabolites in the breath of immunocompromised patients with suspected invasive aspergillosis, with excellent sensitivity and specificity, a single-center study demonstrated.

"We envision this work can be adapted to a rapid, noninvasive point-of-care detection system for real-time surveillance of patient breath for the emergence of aspergillosis and potentially for the diagnosis of lung infections caused by other fungal and bacterial pathogens," Dr. Sophia Koo said in an interview prior to a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"An urgent need" exists for better diagnostic tests for invasive aspergillosis, a life-threatening fungal pneumonia in immunocompromised patients, explained Dr. Koo of Harvard Medical School, Boston. Current diagnostic tests – respiratory tract cultures, serum and bronchoalveolar lavage for fungal antigen testing, and nucleic acid detection assays – "have significant limitations in their sensitivity and specificity, and the turnaround time of these assays in clinical practice is often days," she said.

Dr. Koo and her colleagues developed a new method to detect volatile fungal metabolites directly in patient breath. First, they defined the fungal volatile metabolite profile of Aspergillus fumigatus, the most common cause of invasive aspergillosis, in in vitro culture. Next, they used gas chromatography–mass spectrometry to detect those metabolites in the breath of 54 immunocompromised patients with suspected invasive aspergillosis pneumonia. Of those 54 patients, 29 ultimately had invasive aspergillosis, and 25 had other causes of pneumonia.

The breathalyzerlike test correctly identified 27 of 29 patients with invasive aspergillosis and 24 of 25 patients without invasive aspergillosis, for an overall diagnostic sensitivity of 93% and a diagnostic specificity of 96%.

"We were a bit surprised by how clearly we were able to discriminate patients with invasive aspergillosis from patients with other pneumonias using this approach," Dr. Koo noted. "When we made our initial plot of breath fungal volatile metabolites, clustered by patients with and without invasive aspergillosis, there was a clear line demarcating the two groups. We expected some differences in the fungal volatile metabolite profile in vitro and in vivo, with the overlay of the host-pathogen interaction, and we did indeed see some fungal metabolites in vivo that we did not see in any of our in vitro experiments."

While Dr. Koo described gas chromatography–mass spectrometry as "labor intensive," she characterized the findings of the current study as "easily translatable to a point of care platform for the detection of these fungal breath metabolites and potentially the diagnosis of other bacterial and fungal pneumonias at the bedside."

Dr. Koo acknowledged certain limitations of the study, including its single-center design and the fact that it will require validation in a larger cohort of patients.

The National Institutes of Health and the Harvard Catalyst/the Harvard Clinical and Translational Science Center Pilot Grant Program supported the study. The authors stated that they have no relevant financial conflicts.

dbrunk@frontlinemedcom.com

DENVER – A novel breathalyzerlike test detected fungal gas metabolites in the breath of immunocompromised patients with suspected invasive aspergillosis, with excellent sensitivity and specificity, a single-center study demonstrated.

"We envision this work can be adapted to a rapid, noninvasive point-of-care detection system for real-time surveillance of patient breath for the emergence of aspergillosis and potentially for the diagnosis of lung infections caused by other fungal and bacterial pathogens," Dr. Sophia Koo said in an interview prior to a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"An urgent need" exists for better diagnostic tests for invasive aspergillosis, a life-threatening fungal pneumonia in immunocompromised patients, explained Dr. Koo of Harvard Medical School, Boston. Current diagnostic tests – respiratory tract cultures, serum and bronchoalveolar lavage for fungal antigen testing, and nucleic acid detection assays – "have significant limitations in their sensitivity and specificity, and the turnaround time of these assays in clinical practice is often days," she said.

Dr. Koo and her colleagues developed a new method to detect volatile fungal metabolites directly in patient breath. First, they defined the fungal volatile metabolite profile of Aspergillus fumigatus, the most common cause of invasive aspergillosis, in in vitro culture. Next, they used gas chromatography–mass spectrometry to detect those metabolites in the breath of 54 immunocompromised patients with suspected invasive aspergillosis pneumonia. Of those 54 patients, 29 ultimately had invasive aspergillosis, and 25 had other causes of pneumonia.

The breathalyzerlike test correctly identified 27 of 29 patients with invasive aspergillosis and 24 of 25 patients without invasive aspergillosis, for an overall diagnostic sensitivity of 93% and a diagnostic specificity of 96%.

"We were a bit surprised by how clearly we were able to discriminate patients with invasive aspergillosis from patients with other pneumonias using this approach," Dr. Koo noted. "When we made our initial plot of breath fungal volatile metabolites, clustered by patients with and without invasive aspergillosis, there was a clear line demarcating the two groups. We expected some differences in the fungal volatile metabolite profile in vitro and in vivo, with the overlay of the host-pathogen interaction, and we did indeed see some fungal metabolites in vivo that we did not see in any of our in vitro experiments."

While Dr. Koo described gas chromatography–mass spectrometry as "labor intensive," she characterized the findings of the current study as "easily translatable to a point of care platform for the detection of these fungal breath metabolites and potentially the diagnosis of other bacterial and fungal pneumonias at the bedside."

Dr. Koo acknowledged certain limitations of the study, including its single-center design and the fact that it will require validation in a larger cohort of patients.

The National Institutes of Health and the Harvard Catalyst/the Harvard Clinical and Translational Science Center Pilot Grant Program supported the study. The authors stated that they have no relevant financial conflicts.

dbrunk@frontlinemedcom.com

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

An estimated 4%-6% of children and adolescents in the United States are severely obese, and the prevalence appears to be on the uptick.

At the same time, existing treatments for the condition are limited in effectiveness and lack widespread availability, a nine-member writing group of experts led by Aaron S. Kelly, Ph.D., reported in a scientific statement from the American Heart Association.

"Severe obesity in young people has grave health consequences," said Dr. Kelly in a press statement. "It’s a much more serious childhood disease than obesity."

The condition "demands attention and clinical management, because if left unchecked, it will have a profound effect on those it afflicts and will place a significant economic and clinical services burden on the future health care system," the writing group cautionedonline Sept. 9 in Circulation. It emphasized that stakeholders at all levels "will need to work together to engage the growing problem of severe pediatric obesity."

The 17-page statement includes a recommendation to define children over age 2 as severely obese if they have either a body mass index that’s at least 20%higher than the 95th percentile for their sex and age, or a BMI score of 35 kg/mm² or higher (Circulation 2013 Sept. 9 [doi:10.1161/CIR.0b013e3182a5cfb3]). According to estimates from the National Health and Nutrition Examination Survey dating back to 1999, 4%-6% of children and adolescents in the United States currently fall into this category. Those same data suggest that severe obesity is the fastest-growing subcategory of obesity in youth.

Dr. Kelly of the division of epidemiology and clinical research in the department of pediatrics at the University of Minnesota, Minneapolis, and his associates discussed numerous associated health risks from being severely obese as a child, in particular the mounting evidence from clinical and population-based studies regarding its link to the development of cardiovascular disease (CVD). "Importantly, obesity and CVD risk factors associated with obesity have been linked to early atherosclerosis in pathological studies of the coronary arteries and aorta in adolescents and young adults," the writing group stated.

Other associated health risks that threaten this subset of patients include hyperinsulinemia, insulin resistance, and prediabetes; obstructive sleep apnea syndrome; nonalcoholic fatty liver disease; musculoskeletal problems; depression and other psychosocial problems; and disordered eating.

Although data regarding the long-term risks of severe pediatric obesity are sparse, the authors noted, "it is well established that obese youth (probably because of the strong tracking of adiposity into adulthood) are more likely to have adverse levels of cardiovascular and metabolic risk factors later in life. Higher BMI is associated with tracking in the higher levels of both blood pressure and lipids in longitudinal pediatric cohort studies. Adolescents with a higher degree of obesity are also much more likely to demonstrate CVD risk factor clustering over time. Rate and degree of obesity development are also important."

The writing group characterized current treatment options for severe pediatric obesity as limited, as most standard approaches to weight loss are insufficient for this group. As for medications, orlistat is the only agent approved for weight loss in adolescents. The largest study of its use in adolescents reported a 2.4% reduction in BMI over the course of 12 months (JAMA 2005;293:2873-83). Other agents that have been studied for pediatric obesity include metformin and exenatide. To date, the "results have demonstrated that treatment elicits only modest reductions in BMI/weight and has relatively little impact on the cardiometabolic risk factor profile in obese youth," the experts wrote. Two weight loss medications recently approved by the Food and Drug Administration to treat obesity in adults, lorcaserin and the combination of phentermine and topiramate, have never been studied in children.

Dr. Kelly and his associates went on to note that bariatric surgery "has generally been effective in reducing body mass index and improving cardiovascular and metabolic risk factors; however, reports of long-term outcomes are few, many youth with severe obesity do not qualify for surgery, and access is limited by lack of insurance coverage."

The scientific statement, which is endorsed by the Obesity Society, includes "a call to action" for innovative ways to "fill the gap between lifestyle/medication and surgery." Proposals include conducting more research on bariatric surgery’s effects and safety; evaluating the effectiveness of lifestyle modification interventions, including adherence to dietary and physical activity plans; funding research to find other useful interventions, including better drugs and medical devices; and recognizing severe obesity as a chronic disease requiring ongoing care and management.

"The task ahead will be arduous and complicated, but the high prevalence and serious consequences of severe obesity require us to commit time, intellectual capital, and financial resources to address it," the writing group concluded.

Dr. Kelly disclosed that he has received research grants from Amylin Pharmaceuticals, the National Institutes of Health/National Institute of Neurological Disorders and Stroke, and the Thrasher Research Fund. He is also a consultant to Novo Nordisk. One other writing group member, Dr. Thomas H. Inge, disclosed that he has received a research grant from Ethicon Endosurgery.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

dbrunk@frontlinemedcom.com

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

An estimated 4%-6% of children and adolescents in the United States are severely obese, and the prevalence appears to be on the uptick.

At the same time, existing treatments for the condition are limited in effectiveness and lack widespread availability, a nine-member writing group of experts led by Aaron S. Kelly, Ph.D., reported in a scientific statement from the American Heart Association.

"Severe obesity in young people has grave health consequences," said Dr. Kelly in a press statement. "It’s a much more serious childhood disease than obesity."

The condition "demands attention and clinical management, because if left unchecked, it will have a profound effect on those it afflicts and will place a significant economic and clinical services burden on the future health care system," the writing group cautionedonline Sept. 9 in Circulation. It emphasized that stakeholders at all levels "will need to work together to engage the growing problem of severe pediatric obesity."

The 17-page statement includes a recommendation to define children over age 2 as severely obese if they have either a body mass index that’s at least 20%higher than the 95th percentile for their sex and age, or a BMI score of 35 kg/mm² or higher (Circulation 2013 Sept. 9 [doi:10.1161/CIR.0b013e3182a5cfb3]). According to estimates from the National Health and Nutrition Examination Survey dating back to 1999, 4%-6% of children and adolescents in the United States currently fall into this category. Those same data suggest that severe obesity is the fastest-growing subcategory of obesity in youth.

Dr. Kelly of the division of epidemiology and clinical research in the department of pediatrics at the University of Minnesota, Minneapolis, and his associates discussed numerous associated health risks from being severely obese as a child, in particular the mounting evidence from clinical and population-based studies regarding its link to the development of cardiovascular disease (CVD). "Importantly, obesity and CVD risk factors associated with obesity have been linked to early atherosclerosis in pathological studies of the coronary arteries and aorta in adolescents and young adults," the writing group stated.

Other associated health risks that threaten this subset of patients include hyperinsulinemia, insulin resistance, and prediabetes; obstructive sleep apnea syndrome; nonalcoholic fatty liver disease; musculoskeletal problems; depression and other psychosocial problems; and disordered eating.

Although data regarding the long-term risks of severe pediatric obesity are sparse, the authors noted, "it is well established that obese youth (probably because of the strong tracking of adiposity into adulthood) are more likely to have adverse levels of cardiovascular and metabolic risk factors later in life. Higher BMI is associated with tracking in the higher levels of both blood pressure and lipids in longitudinal pediatric cohort studies. Adolescents with a higher degree of obesity are also much more likely to demonstrate CVD risk factor clustering over time. Rate and degree of obesity development are also important."

The writing group characterized current treatment options for severe pediatric obesity as limited, as most standard approaches to weight loss are insufficient for this group. As for medications, orlistat is the only agent approved for weight loss in adolescents. The largest study of its use in adolescents reported a 2.4% reduction in BMI over the course of 12 months (JAMA 2005;293:2873-83). Other agents that have been studied for pediatric obesity include metformin and exenatide. To date, the "results have demonstrated that treatment elicits only modest reductions in BMI/weight and has relatively little impact on the cardiometabolic risk factor profile in obese youth," the experts wrote. Two weight loss medications recently approved by the Food and Drug Administration to treat obesity in adults, lorcaserin and the combination of phentermine and topiramate, have never been studied in children.

Dr. Kelly and his associates went on to note that bariatric surgery "has generally been effective in reducing body mass index and improving cardiovascular and metabolic risk factors; however, reports of long-term outcomes are few, many youth with severe obesity do not qualify for surgery, and access is limited by lack of insurance coverage."

The scientific statement, which is endorsed by the Obesity Society, includes "a call to action" for innovative ways to "fill the gap between lifestyle/medication and surgery." Proposals include conducting more research on bariatric surgery’s effects and safety; evaluating the effectiveness of lifestyle modification interventions, including adherence to dietary and physical activity plans; funding research to find other useful interventions, including better drugs and medical devices; and recognizing severe obesity as a chronic disease requiring ongoing care and management.

"The task ahead will be arduous and complicated, but the high prevalence and serious consequences of severe obesity require us to commit time, intellectual capital, and financial resources to address it," the writing group concluded.

Dr. Kelly disclosed that he has received research grants from Amylin Pharmaceuticals, the National Institutes of Health/National Institute of Neurological Disorders and Stroke, and the Thrasher Research Fund. He is also a consultant to Novo Nordisk. One other writing group member, Dr. Thomas H. Inge, disclosed that he has received a research grant from Ethicon Endosurgery.

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dbrunk@frontlinemedcom.com

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An estimated 4%-6% of children and adolescents in the United States are severely obese, and the prevalence appears to be on the uptick.

At the same time, existing treatments for the condition are limited in effectiveness and lack widespread availability, a nine-member writing group of experts led by Aaron S. Kelly, Ph.D., reported in a scientific statement from the American Heart Association.

"Severe obesity in young people has grave health consequences," said Dr. Kelly in a press statement. "It’s a much more serious childhood disease than obesity."

The condition "demands attention and clinical management, because if left unchecked, it will have a profound effect on those it afflicts and will place a significant economic and clinical services burden on the future health care system," the writing group cautionedonline Sept. 9 in Circulation. It emphasized that stakeholders at all levels "will need to work together to engage the growing problem of severe pediatric obesity."

The 17-page statement includes a recommendation to define children over age 2 as severely obese if they have either a body mass index that’s at least 20%higher than the 95th percentile for their sex and age, or a BMI score of 35 kg/mm² or higher (Circulation 2013 Sept. 9 [doi:10.1161/CIR.0b013e3182a5cfb3]). According to estimates from the National Health and Nutrition Examination Survey dating back to 1999, 4%-6% of children and adolescents in the United States currently fall into this category. Those same data suggest that severe obesity is the fastest-growing subcategory of obesity in youth.

Dr. Kelly of the division of epidemiology and clinical research in the department of pediatrics at the University of Minnesota, Minneapolis, and his associates discussed numerous associated health risks from being severely obese as a child, in particular the mounting evidence from clinical and population-based studies regarding its link to the development of cardiovascular disease (CVD). "Importantly, obesity and CVD risk factors associated with obesity have been linked to early atherosclerosis in pathological studies of the coronary arteries and aorta in adolescents and young adults," the writing group stated.

Other associated health risks that threaten this subset of patients include hyperinsulinemia, insulin resistance, and prediabetes; obstructive sleep apnea syndrome; nonalcoholic fatty liver disease; musculoskeletal problems; depression and other psychosocial problems; and disordered eating.

Although data regarding the long-term risks of severe pediatric obesity are sparse, the authors noted, "it is well established that obese youth (probably because of the strong tracking of adiposity into adulthood) are more likely to have adverse levels of cardiovascular and metabolic risk factors later in life. Higher BMI is associated with tracking in the higher levels of both blood pressure and lipids in longitudinal pediatric cohort studies. Adolescents with a higher degree of obesity are also much more likely to demonstrate CVD risk factor clustering over time. Rate and degree of obesity development are also important."

The writing group characterized current treatment options for severe pediatric obesity as limited, as most standard approaches to weight loss are insufficient for this group. As for medications, orlistat is the only agent approved for weight loss in adolescents. The largest study of its use in adolescents reported a 2.4% reduction in BMI over the course of 12 months (JAMA 2005;293:2873-83). Other agents that have been studied for pediatric obesity include metformin and exenatide. To date, the "results have demonstrated that treatment elicits only modest reductions in BMI/weight and has relatively little impact on the cardiometabolic risk factor profile in obese youth," the experts wrote. Two weight loss medications recently approved by the Food and Drug Administration to treat obesity in adults, lorcaserin and the combination of phentermine and topiramate, have never been studied in children.

Dr. Kelly and his associates went on to note that bariatric surgery "has generally been effective in reducing body mass index and improving cardiovascular and metabolic risk factors; however, reports of long-term outcomes are few, many youth with severe obesity do not qualify for surgery, and access is limited by lack of insurance coverage."

The scientific statement, which is endorsed by the Obesity Society, includes "a call to action" for innovative ways to "fill the gap between lifestyle/medication and surgery." Proposals include conducting more research on bariatric surgery’s effects and safety; evaluating the effectiveness of lifestyle modification interventions, including adherence to dietary and physical activity plans; funding research to find other useful interventions, including better drugs and medical devices; and recognizing severe obesity as a chronic disease requiring ongoing care and management.

"The task ahead will be arduous and complicated, but the high prevalence and serious consequences of severe obesity require us to commit time, intellectual capital, and financial resources to address it," the writing group concluded.

Dr. Kelly disclosed that he has received research grants from Amylin Pharmaceuticals, the National Institutes of Health/National Institute of Neurological Disorders and Stroke, and the Thrasher Research Fund. He is also a consultant to Novo Nordisk. One other writing group member, Dr. Thomas H. Inge, disclosed that he has received a research grant from Ethicon Endosurgery.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

dbrunk@frontlinemedcom.com