Heidi Splete

NATIONAL HARBOR, MD. – Use of a combination of bazedoxifene and conjugated estrogens had no significant impact on breast density (a potential risk factor for breast cancer) in postmenopausal women, based on data from the SMART-5 trial.

“Preclinical studies have suggested that the selective estrogen receptor modulator (SERM) bazedoxifene (BZA) prevents estrogen-induced stimulation of breast tissue,” said Dr. JoAnn V. Pinkerton of the University of Virginia, Charlottesville.

The Selective Estrogens, Menopause, and Response to Therapy (SMART)-5 study was a 1-year, randomized, double-blind, placebo-controlled, phase III study of healthy postmenopausal women with a uterus who sought treatment for vasomotor symptoms. A subset of 940 women from this study took part in a breast density substudy to assess changes in breast density after a year of treatment with BZA/conjugated estrogens, compared to other treatment or a placebo. The women underwent mammograms at baseline and again after 1 year of treatment. Changes in breast density were assessed using an analysis of covariance (ANCOVA) model.

After 1 year, the mean adjusted change in breast density from baseline was −0.38% in the women who were received 20 mg BZA/0.45 mg conjugated estrogens, −0.44 in the women who received 20 mg BZA/0.625 conjugated estrogens, −0.24% in the women who received 20 mg BZA alone, 1.60% in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate, and −0.32% in the women who received a placebo.

The only significant difference in breast density either within group or versus placebo occurred in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate. In addition, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg showed noninferiority to placebo for breast density at 1 year.

Four abnormal mammograms were seen in the 20-mg BZA/0.45-mg conjugated estrogens group, two in the 20-mg BZA/0.625-mg conjugated estrogens group, one in the 20-mg BZA alone group, three in the 0.45-mg conjugated estrogens/1.5-mg medroxyprogesterone acetate group, and one in the placebo group.

Two cases of breast cancer were reported in the 20-mg BZA/0.45-mg conjugated estrogens group, compared to one case in the 0.45-mg conjugated estrogens/1.5-mg medroxyprogesterone acetate group, one case in the placebo group, and none in the other groups.

The mean age of the women was 54 years, and they were menopausal from 4 to 5 years. Approximately 90% were white. The demographics were similar among all five groups. Overall, there was no significant difference in the incidence of breast-related adverse events among the groups.

The findings are consistent with those from a previous retrospective study of the SMART-5 data, said Dr. Pinkerton.

“The favorable breast effects seen with BZA 20 mg/CE 0.45 mg and 0.625 mg in this prospective evaluation are a potential advantage of BZA/CE over conventional estrogen/progestin therapy,” for postmenopausal women with a uterus, she said.

The study was sponsored by Wyeth Research, now a division of Pfizer, and several of the study coinvestigators are Pfizer employees. Dr. Pinkerton has received fees given to the University of Virginia. She has served as a consultant to Pfizer, Teva, Depomed, and Novo Nordisk, received grants or research support from Pfizer, Depomed, and EndoCeutics, and served on the data safety monitoring board for Boehringer Ingelheim.

A video with Dr. Pinkerton can be viewed by using the QR code or by visiting www.obgynnews.com

Preclinical studies have suggested that BZA prevents estrogen-induced stimulation of breast tissue.

Source DR. PINKERTON

NATIONAL HARBOR, MD. – Use of a combination of bazedoxifene and conjugated estrogens had no significant impact on breast density (a potential risk factor for breast cancer) in postmenopausal women, based on data from the SMART-5 trial.

“Preclinical studies have suggested that the selective estrogen receptor modulator (SERM) bazedoxifene (BZA) prevents estrogen-induced stimulation of breast tissue,” said Dr. JoAnn V. Pinkerton of the University of Virginia, Charlottesville.

The Selective Estrogens, Menopause, and Response to Therapy (SMART)-5 study was a 1-year, randomized, double-blind, placebo-controlled, phase III study of healthy postmenopausal women with a uterus who sought treatment for vasomotor symptoms. A subset of 940 women from this study took part in a breast density substudy to assess changes in breast density after a year of treatment with BZA/conjugated estrogens, compared to other treatment or a placebo. The women underwent mammograms at baseline and again after 1 year of treatment. Changes in breast density were assessed using an analysis of covariance (ANCOVA) model.

After 1 year, the mean adjusted change in breast density from baseline was −0.38% in the women who were received 20 mg BZA/0.45 mg conjugated estrogens, −0.44 in the women who received 20 mg BZA/0.625 conjugated estrogens, −0.24% in the women who received 20 mg BZA alone, 1.60% in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate, and −0.32% in the women who received a placebo.

The only significant difference in breast density either within group or versus placebo occurred in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate. In addition, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg showed noninferiority to placebo for breast density at 1 year.

Four abnormal mammograms were seen in the 20-mg BZA/0.45-mg conjugated estrogens group, two in the 20-mg BZA/0.625-mg conjugated estrogens group, one in the 20-mg BZA alone group, three in the 0.45-mg conjugated estrogens/1.5-mg medroxyprogesterone acetate group, and one in the placebo group.

Two cases of breast cancer were reported in the 20-mg BZA/0.45-mg conjugated estrogens group, compared to one case in the 0.45-mg conjugated estrogens/1.5-mg medroxyprogesterone acetate group, one case in the placebo group, and none in the other groups.

The mean age of the women was 54 years, and they were menopausal from 4 to 5 years. Approximately 90% were white. The demographics were similar among all five groups. Overall, there was no significant difference in the incidence of breast-related adverse events among the groups.

The findings are consistent with those from a previous retrospective study of the SMART-5 data, said Dr. Pinkerton.

“The favorable breast effects seen with BZA 20 mg/CE 0.45 mg and 0.625 mg in this prospective evaluation are a potential advantage of BZA/CE over conventional estrogen/progestin therapy,” for postmenopausal women with a uterus, she said.

The study was sponsored by Wyeth Research, now a division of Pfizer, and several of the study coinvestigators are Pfizer employees. Dr. Pinkerton has received fees given to the University of Virginia. She has served as a consultant to Pfizer, Teva, Depomed, and Novo Nordisk, received grants or research support from Pfizer, Depomed, and EndoCeutics, and served on the data safety monitoring board for Boehringer Ingelheim.

A video with Dr. Pinkerton can be viewed by using the QR code or by visiting www.obgynnews.com

Preclinical studies have suggested that BZA prevents estrogen-induced stimulation of breast tissue.

Source DR. PINKERTON

NATIONAL HARBOR, MD. – Use of a combination of bazedoxifene and conjugated estrogens had no significant impact on breast density (a potential risk factor for breast cancer) in postmenopausal women, based on data from the SMART-5 trial.

“Preclinical studies have suggested that the selective estrogen receptor modulator (SERM) bazedoxifene (BZA) prevents estrogen-induced stimulation of breast tissue,” said Dr. JoAnn V. Pinkerton of the University of Virginia, Charlottesville.

The Selective Estrogens, Menopause, and Response to Therapy (SMART)-5 study was a 1-year, randomized, double-blind, placebo-controlled, phase III study of healthy postmenopausal women with a uterus who sought treatment for vasomotor symptoms. A subset of 940 women from this study took part in a breast density substudy to assess changes in breast density after a year of treatment with BZA/conjugated estrogens, compared to other treatment or a placebo. The women underwent mammograms at baseline and again after 1 year of treatment. Changes in breast density were assessed using an analysis of covariance (ANCOVA) model.

After 1 year, the mean adjusted change in breast density from baseline was −0.38% in the women who were received 20 mg BZA/0.45 mg conjugated estrogens, −0.44 in the women who received 20 mg BZA/0.625 conjugated estrogens, −0.24% in the women who received 20 mg BZA alone, 1.60% in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate, and −0.32% in the women who received a placebo.

The only significant difference in breast density either within group or versus placebo occurred in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate. In addition, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg showed noninferiority to placebo for breast density at 1 year.

Four abnormal mammograms were seen in the 20-mg BZA/0.45-mg conjugated estrogens group, two in the 20-mg BZA/0.625-mg conjugated estrogens group, one in the 20-mg BZA alone group, three in the 0.45-mg conjugated estrogens/1.5-mg medroxyprogesterone acetate group, and one in the placebo group.

Two cases of breast cancer were reported in the 20-mg BZA/0.45-mg conjugated estrogens group, compared to one case in the 0.45-mg conjugated estrogens/1.5-mg medroxyprogesterone acetate group, one case in the placebo group, and none in the other groups.

The mean age of the women was 54 years, and they were menopausal from 4 to 5 years. Approximately 90% were white. The demographics were similar among all five groups. Overall, there was no significant difference in the incidence of breast-related adverse events among the groups.

The findings are consistent with those from a previous retrospective study of the SMART-5 data, said Dr. Pinkerton.

“The favorable breast effects seen with BZA 20 mg/CE 0.45 mg and 0.625 mg in this prospective evaluation are a potential advantage of BZA/CE over conventional estrogen/progestin therapy,” for postmenopausal women with a uterus, she said.

The study was sponsored by Wyeth Research, now a division of Pfizer, and several of the study coinvestigators are Pfizer employees. Dr. Pinkerton has received fees given to the University of Virginia. She has served as a consultant to Pfizer, Teva, Depomed, and Novo Nordisk, received grants or research support from Pfizer, Depomed, and EndoCeutics, and served on the data safety monitoring board for Boehringer Ingelheim.

A video with Dr. Pinkerton can be viewed by using the QR code or by visiting www.obgynnews.com

Preclinical studies have suggested that BZA prevents estrogen-induced stimulation of breast tissue.

Source DR. PINKERTON

NATIONAL HARBOR, MD – Fecal microbiota transplants showed long-term effectiveness in eliminating recurrent Clostridium difficile infections, based on data from 77 patients.

The findings were presented at the annual meeting of the American College of Gastroenterology.

C. difficile is responsible for approximately 500,000 infections and 15,000 deaths annually in the United States, said Dr. Mark Mellow, medical director of the digestive health center at INTEGRIS Baptist Medical Center in Oklahoma City. In addition, recurrence rates after an initial infection range from 15% to 25%, and the rate of recurrence after a recurrent infection ranges from 40% to 50%.

The fecal microbiota transplant (FMT) procedure has shown success in treating C. difficile, but long-term follow-up data are limited, Dr. Mellow said.

In this study, Dr. Mellow and his colleagues contacted patients who underwent colonoscopic FMT for recurrent C. difficile infections at least 3 months previously, via a mail or phone questionnaire. The patient population came from five different centers and included 56 women and 21 men. The patients ranged in age from 22 to 87 years, with a mean age of 65 years and an average illness duration of 11 months.

Pre-FMT data included health status, duration of infection, previous treatments, risk factors, and characteristics of the fecal donor. Post-FMT data included the effect of FMT on symptoms, time to improvement, and, in some cases, follow-up stool testing.

The average time to resolution of diarrhea after FMT was 6 days overall. Time to resolution was 3 days or less in 57 patients. Fatigue resolved in an average of 4 weeks overall, and in 1 week or less in 51 patients, Dr. Mellow said.

After an average of 17 months’ follow-up, 70 patients (91%) reported no recurrence of C. difficile.

"Despite lengthy illness before FMT, the response to FMT was rapid and sustained," and no patient developed a recurrent infection that did not receive subsequent antibiotic treatment for other infections, Dr. Mellow said.

Of the seven patients who failed an initial FMT treatment, four were successfully treated with a 2-week course of vancomycin alone or in combination with Florastor, Alinia, and kefir. Another two were treated successfully with a second FMT after failing a 2-week course of vancomycin, and one patient was not treated and died after spending time in hospice care.

The FMT procedure was well received in this patient population, most of whom had suffered with recurrent infection and failed multiple courses of standard treatments, Dr. Mellow noted. When patients were asked about their preferred treatment if their C. difficile infections were to recur, 53% said they would have a second FMT as their first choice for therapy, he said.

The findings were similar across all five centers, and support the effectiveness of FMT as a treatment option for patients with at least two prior bouts of C. difficile, Dr. Mellow said.

Dr. Mellow had no financial conflicts to disclose.

NATIONAL HARBOR, MD – Fecal microbiota transplants showed long-term effectiveness in eliminating recurrent Clostridium difficile infections, based on data from 77 patients.

The findings were presented at the annual meeting of the American College of Gastroenterology.

C. difficile is responsible for approximately 500,000 infections and 15,000 deaths annually in the United States, said Dr. Mark Mellow, medical director of the digestive health center at INTEGRIS Baptist Medical Center in Oklahoma City. In addition, recurrence rates after an initial infection range from 15% to 25%, and the rate of recurrence after a recurrent infection ranges from 40% to 50%.

The fecal microbiota transplant (FMT) procedure has shown success in treating C. difficile, but long-term follow-up data are limited, Dr. Mellow said.

In this study, Dr. Mellow and his colleagues contacted patients who underwent colonoscopic FMT for recurrent C. difficile infections at least 3 months previously, via a mail or phone questionnaire. The patient population came from five different centers and included 56 women and 21 men. The patients ranged in age from 22 to 87 years, with a mean age of 65 years and an average illness duration of 11 months.

Pre-FMT data included health status, duration of infection, previous treatments, risk factors, and characteristics of the fecal donor. Post-FMT data included the effect of FMT on symptoms, time to improvement, and, in some cases, follow-up stool testing.

The average time to resolution of diarrhea after FMT was 6 days overall. Time to resolution was 3 days or less in 57 patients. Fatigue resolved in an average of 4 weeks overall, and in 1 week or less in 51 patients, Dr. Mellow said.

After an average of 17 months’ follow-up, 70 patients (91%) reported no recurrence of C. difficile.

"Despite lengthy illness before FMT, the response to FMT was rapid and sustained," and no patient developed a recurrent infection that did not receive subsequent antibiotic treatment for other infections, Dr. Mellow said.

Of the seven patients who failed an initial FMT treatment, four were successfully treated with a 2-week course of vancomycin alone or in combination with Florastor, Alinia, and kefir. Another two were treated successfully with a second FMT after failing a 2-week course of vancomycin, and one patient was not treated and died after spending time in hospice care.

The FMT procedure was well received in this patient population, most of whom had suffered with recurrent infection and failed multiple courses of standard treatments, Dr. Mellow noted. When patients were asked about their preferred treatment if their C. difficile infections were to recur, 53% said they would have a second FMT as their first choice for therapy, he said.

The findings were similar across all five centers, and support the effectiveness of FMT as a treatment option for patients with at least two prior bouts of C. difficile, Dr. Mellow said.

Dr. Mellow had no financial conflicts to disclose.

NATIONAL HARBOR, MD – Fecal microbiota transplants showed long-term effectiveness in eliminating recurrent Clostridium difficile infections, based on data from 77 patients.

The findings were presented at the annual meeting of the American College of Gastroenterology.

C. difficile is responsible for approximately 500,000 infections and 15,000 deaths annually in the United States, said Dr. Mark Mellow, medical director of the digestive health center at INTEGRIS Baptist Medical Center in Oklahoma City. In addition, recurrence rates after an initial infection range from 15% to 25%, and the rate of recurrence after a recurrent infection ranges from 40% to 50%.

The fecal microbiota transplant (FMT) procedure has shown success in treating C. difficile, but long-term follow-up data are limited, Dr. Mellow said.

In this study, Dr. Mellow and his colleagues contacted patients who underwent colonoscopic FMT for recurrent C. difficile infections at least 3 months previously, via a mail or phone questionnaire. The patient population came from five different centers and included 56 women and 21 men. The patients ranged in age from 22 to 87 years, with a mean age of 65 years and an average illness duration of 11 months.

Pre-FMT data included health status, duration of infection, previous treatments, risk factors, and characteristics of the fecal donor. Post-FMT data included the effect of FMT on symptoms, time to improvement, and, in some cases, follow-up stool testing.

The average time to resolution of diarrhea after FMT was 6 days overall. Time to resolution was 3 days or less in 57 patients. Fatigue resolved in an average of 4 weeks overall, and in 1 week or less in 51 patients, Dr. Mellow said.

After an average of 17 months’ follow-up, 70 patients (91%) reported no recurrence of C. difficile.

"Despite lengthy illness before FMT, the response to FMT was rapid and sustained," and no patient developed a recurrent infection that did not receive subsequent antibiotic treatment for other infections, Dr. Mellow said.

Of the seven patients who failed an initial FMT treatment, four were successfully treated with a 2-week course of vancomycin alone or in combination with Florastor, Alinia, and kefir. Another two were treated successfully with a second FMT after failing a 2-week course of vancomycin, and one patient was not treated and died after spending time in hospice care.

The FMT procedure was well received in this patient population, most of whom had suffered with recurrent infection and failed multiple courses of standard treatments, Dr. Mellow noted. When patients were asked about their preferred treatment if their C. difficile infections were to recur, 53% said they would have a second FMT as their first choice for therapy, he said.

The findings were similar across all five centers, and support the effectiveness of FMT as a treatment option for patients with at least two prior bouts of C. difficile, Dr. Mellow said.

Dr. Mellow had no financial conflicts to disclose.

PARIS – Patients with mild traumatic brain injury who reported all or nothing behavior were significantly more likely to have postconcussional syndrome 3 months later, data from a prospective study of 107 adults have shown.

Approximately 15%-30% of mild traumatic brain injury (MTBI) patients are at risk of developing postconcussional syndrome (PCS), Dr. Ruihua Hou of the University of Southampton (England) explained at the annual meeting of the European Congress of Neuropsychopharmacology.

PCS is a symptom cluster that includes physical, cognitive, emotional, and behavioral symptoms. To investigate the etiology of PCS, the researchers developed a cognitive-behavioral model that compared MTBI patients who did and did not develop the syndrome.

Patients were assessed for cognitive, behavioral, emotional, and social variables at baseline using the Brief Illness Perception Questionnaire, the Behavioral Responses to Illness Questionnaire, the Impact of Events Scale, the Hospital Anxiety and Depression Scale, the Anxiety Sensitivity Index, and the Brief Social Support Questionnaire.

At the 3- and 6-month follow-up visits, the researchers used the Rivermead Post-Concussion Symptoms Questionnaire to assess the severity of PCS symptoms and the ICD-10 code F07.2 to diagnose PCS.

All or nothing behavior shortly after MTBI was a significant predictor for the onset of PCS at 3 months (odds ratio, 1.141).

However, all or nothing behavior was not a significant predictor of PCS after 6 months, the researchers noted. Instead, patients’ early negative injury perception was a significant predictor of the onset of PCS after 6 months (odds ratio, 1.053).

At 3 months and 6 months, no significant differences were observed between PCS cases and noncases with regard to demographics, including age, sex, education level, and occupation.

Although the findings were limited by the prospective nature of the study, they provide support for the cognitive model that was used, Dr. Hou said.

In addition, "the findings provide research evidence for the role of illness perception and coping behavior shortly after MTBI in the development of PCS and indicate that they may be important early-intervention targets," Dr. Hou emphasized.

The study was funded by the Faculty of Medicine Research Management Committee at the University of Southampton. The researchers said they had no relevant financial disclosures.

PARIS – Patients with mild traumatic brain injury who reported all or nothing behavior were significantly more likely to have postconcussional syndrome 3 months later, data from a prospective study of 107 adults have shown.

Approximately 15%-30% of mild traumatic brain injury (MTBI) patients are at risk of developing postconcussional syndrome (PCS), Dr. Ruihua Hou of the University of Southampton (England) explained at the annual meeting of the European Congress of Neuropsychopharmacology.

PCS is a symptom cluster that includes physical, cognitive, emotional, and behavioral symptoms. To investigate the etiology of PCS, the researchers developed a cognitive-behavioral model that compared MTBI patients who did and did not develop the syndrome.

Patients were assessed for cognitive, behavioral, emotional, and social variables at baseline using the Brief Illness Perception Questionnaire, the Behavioral Responses to Illness Questionnaire, the Impact of Events Scale, the Hospital Anxiety and Depression Scale, the Anxiety Sensitivity Index, and the Brief Social Support Questionnaire.

At the 3- and 6-month follow-up visits, the researchers used the Rivermead Post-Concussion Symptoms Questionnaire to assess the severity of PCS symptoms and the ICD-10 code F07.2 to diagnose PCS.

All or nothing behavior shortly after MTBI was a significant predictor for the onset of PCS at 3 months (odds ratio, 1.141).

However, all or nothing behavior was not a significant predictor of PCS after 6 months, the researchers noted. Instead, patients’ early negative injury perception was a significant predictor of the onset of PCS after 6 months (odds ratio, 1.053).

At 3 months and 6 months, no significant differences were observed between PCS cases and noncases with regard to demographics, including age, sex, education level, and occupation.

Although the findings were limited by the prospective nature of the study, they provide support for the cognitive model that was used, Dr. Hou said.

In addition, "the findings provide research evidence for the role of illness perception and coping behavior shortly after MTBI in the development of PCS and indicate that they may be important early-intervention targets," Dr. Hou emphasized.

The study was funded by the Faculty of Medicine Research Management Committee at the University of Southampton. The researchers said they had no relevant financial disclosures.

PARIS – Patients with mild traumatic brain injury who reported all or nothing behavior were significantly more likely to have postconcussional syndrome 3 months later, data from a prospective study of 107 adults have shown.

Approximately 15%-30% of mild traumatic brain injury (MTBI) patients are at risk of developing postconcussional syndrome (PCS), Dr. Ruihua Hou of the University of Southampton (England) explained at the annual meeting of the European Congress of Neuropsychopharmacology.

PCS is a symptom cluster that includes physical, cognitive, emotional, and behavioral symptoms. To investigate the etiology of PCS, the researchers developed a cognitive-behavioral model that compared MTBI patients who did and did not develop the syndrome.

Patients were assessed for cognitive, behavioral, emotional, and social variables at baseline using the Brief Illness Perception Questionnaire, the Behavioral Responses to Illness Questionnaire, the Impact of Events Scale, the Hospital Anxiety and Depression Scale, the Anxiety Sensitivity Index, and the Brief Social Support Questionnaire.

At the 3- and 6-month follow-up visits, the researchers used the Rivermead Post-Concussion Symptoms Questionnaire to assess the severity of PCS symptoms and the ICD-10 code F07.2 to diagnose PCS.

All or nothing behavior shortly after MTBI was a significant predictor for the onset of PCS at 3 months (odds ratio, 1.141).

However, all or nothing behavior was not a significant predictor of PCS after 6 months, the researchers noted. Instead, patients’ early negative injury perception was a significant predictor of the onset of PCS after 6 months (odds ratio, 1.053).

At 3 months and 6 months, no significant differences were observed between PCS cases and noncases with regard to demographics, including age, sex, education level, and occupation.

Although the findings were limited by the prospective nature of the study, they provide support for the cognitive model that was used, Dr. Hou said.

In addition, "the findings provide research evidence for the role of illness perception and coping behavior shortly after MTBI in the development of PCS and indicate that they may be important early-intervention targets," Dr. Hou emphasized.

The study was funded by the Faculty of Medicine Research Management Committee at the University of Southampton. The researchers said they had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Treating patients with both rosacea and small intestinal bacterial overgrowth with the drug rifaximin was associated with improved rosacea symptoms in some patients, in a small, preliminary study. The findings were presented at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a relationship between gastrointestinal bacteria and various skin disorders such as scleroderma, and a small case series showed that rosacea improved when patients with small intestinal bacterial overgrowth (SIBO) were treated with rifaximin, said Dr. Leonard B. Weinstock of Specialists in Gastroenterology in St. Louis.

Dr. Weinstock identified 63 patients with rosacea; the average age of the patients was 56 years. Most of them, 57 patients, had been diagnosed with facial rosacea by a dermatologist, and 4 had been diagnosed with ocular rosacea by an ophthalmologist. The rosacea patients were compared to 30 healthy controls and 30 general population controls. All study participants underwent lactulose breath testing to determine whether they had SIBO.

Overall, SIBO was significantly more common in the rosacea patients (50%) than in the general population controls (23%) or the healthy controls (10%). All four patients with ocular rosacea had SIBO.

A total of 32 rosacea patients were positive for SIBO, and 28 of these (including all ocular rosacea patients) received 1200 mg/day of rifaximin (two 200-mg tablets 3 times daily) for 10 days. Of the treated patients, 46% showed clearance of, or marked improvement in, rosacea symptoms, while another 25% showed moderate improvement.

"All four patients with ocular rosacea and SIBO reported marked improvement in conjunctivitis, sclera erythema, and dry eyes following treatment with rifaximin," Dr. Weinstock noted.

A large, randomized clinical trial is underway to further explore the possible benefits of rifaximin in patients with rosacea and SIBO, Dr. Weinstock added.

The study was supported by a grant from Salix Pharmaceuticals, maker of rifaximin.

NATIONAL HARBOR, MD. – Treating patients with both rosacea and small intestinal bacterial overgrowth with the drug rifaximin was associated with improved rosacea symptoms in some patients, in a small, preliminary study. The findings were presented at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a relationship between gastrointestinal bacteria and various skin disorders such as scleroderma, and a small case series showed that rosacea improved when patients with small intestinal bacterial overgrowth (SIBO) were treated with rifaximin, said Dr. Leonard B. Weinstock of Specialists in Gastroenterology in St. Louis.

Dr. Weinstock identified 63 patients with rosacea; the average age of the patients was 56 years. Most of them, 57 patients, had been diagnosed with facial rosacea by a dermatologist, and 4 had been diagnosed with ocular rosacea by an ophthalmologist. The rosacea patients were compared to 30 healthy controls and 30 general population controls. All study participants underwent lactulose breath testing to determine whether they had SIBO.

Overall, SIBO was significantly more common in the rosacea patients (50%) than in the general population controls (23%) or the healthy controls (10%). All four patients with ocular rosacea had SIBO.

A total of 32 rosacea patients were positive for SIBO, and 28 of these (including all ocular rosacea patients) received 1200 mg/day of rifaximin (two 200-mg tablets 3 times daily) for 10 days. Of the treated patients, 46% showed clearance of, or marked improvement in, rosacea symptoms, while another 25% showed moderate improvement.

"All four patients with ocular rosacea and SIBO reported marked improvement in conjunctivitis, sclera erythema, and dry eyes following treatment with rifaximin," Dr. Weinstock noted.

A large, randomized clinical trial is underway to further explore the possible benefits of rifaximin in patients with rosacea and SIBO, Dr. Weinstock added.

The study was supported by a grant from Salix Pharmaceuticals, maker of rifaximin.

NATIONAL HARBOR, MD. – Treating patients with both rosacea and small intestinal bacterial overgrowth with the drug rifaximin was associated with improved rosacea symptoms in some patients, in a small, preliminary study. The findings were presented at the annual meeting of the American College of Gastroenterology.

Previous studies have shown a relationship between gastrointestinal bacteria and various skin disorders such as scleroderma, and a small case series showed that rosacea improved when patients with small intestinal bacterial overgrowth (SIBO) were treated with rifaximin, said Dr. Leonard B. Weinstock of Specialists in Gastroenterology in St. Louis.

Dr. Weinstock identified 63 patients with rosacea; the average age of the patients was 56 years. Most of them, 57 patients, had been diagnosed with facial rosacea by a dermatologist, and 4 had been diagnosed with ocular rosacea by an ophthalmologist. The rosacea patients were compared to 30 healthy controls and 30 general population controls. All study participants underwent lactulose breath testing to determine whether they had SIBO.

Overall, SIBO was significantly more common in the rosacea patients (50%) than in the general population controls (23%) or the healthy controls (10%). All four patients with ocular rosacea had SIBO.

A total of 32 rosacea patients were positive for SIBO, and 28 of these (including all ocular rosacea patients) received 1200 mg/day of rifaximin (two 200-mg tablets 3 times daily) for 10 days. Of the treated patients, 46% showed clearance of, or marked improvement in, rosacea symptoms, while another 25% showed moderate improvement.

"All four patients with ocular rosacea and SIBO reported marked improvement in conjunctivitis, sclera erythema, and dry eyes following treatment with rifaximin," Dr. Weinstock noted.

A large, randomized clinical trial is underway to further explore the possible benefits of rifaximin in patients with rosacea and SIBO, Dr. Weinstock added.

The study was supported by a grant from Salix Pharmaceuticals, maker of rifaximin.

NATIONAL HARBOR, MD. – Polyp detection rates were significantly higher among endoscopists who completed a quality-improvement training program, compared with rates of those who did not in a randomized, controlled trial of 15 endoscopists and 2,400 procedures. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenoma detection rate is a key quality indicator for colonoscopy, and previous studies have shown associations between physicians’ behavior (such as looking behind folds, and the time spent inspecting the colon) and rates of adenoma detection, said Dr. Susan Coe of the Mayo Clinic in Jacksonville, Fla.

However, attempts at improving polyp detection rates, including discussions with low-performing physicians, required withdrawal times, and financial penalties, have proven unsuccessful, she said.

Dr. Coe and her colleagues, including senior investigator Dr. Michael B. Wallace, designed a prospective, randomized educational intervention to determine whether targeted endoscopist training would increase polyp detection rates.

"This is the first study to our knowledge to prospectively show that adenoma detection rate can be significantly improved through an intensive, structured endoscopist training program," Dr. Coe said.

In the first phase of the study, the endoscopists performed 1,200 colonoscopies to determine their baseline detection rates. The average baseline rate was 36% among endoscopists randomized to both the training and non-training groups.

In the second phase of the study, the endoscopists performed another 1,200 colonoscopies after half of them had completed the training program. Among endoscopists in the training group, the average adenoma detection rate increased significantly to 47%, compared to 35% in the non-training group.

The Endoscopic Quality Improvement Program consisted of two 1-hour small group sessions. The first session included literature, photo, and video examples of polyps, explanations of techniques from high-detecting endoscopists, and information about subtle lesions such as flat and serrated polyps.

The second session consisted of a validated surface pattern recognition exercise. The participants in the training program received monthly feedback on their adenoma detection rates, withdrawal times, and group averages after completing the program.

The baseline characteristics of the endoscopists who underwent training and those who did not were similar overall. Median age in the trained and untrained groups was 45 years and 50 years, respectively.

Dr. Coe noted that the findings were limited by the small number of endoscopists and the single setting, but the study is ongoing to see whether the improvements associated with training persist. Larger studies are also planned, she said.

Dr. Coe said she had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Polyp detection rates were significantly higher among endoscopists who completed a quality-improvement training program, compared with rates of those who did not in a randomized, controlled trial of 15 endoscopists and 2,400 procedures. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenoma detection rate is a key quality indicator for colonoscopy, and previous studies have shown associations between physicians’ behavior (such as looking behind folds, and the time spent inspecting the colon) and rates of adenoma detection, said Dr. Susan Coe of the Mayo Clinic in Jacksonville, Fla.

However, attempts at improving polyp detection rates, including discussions with low-performing physicians, required withdrawal times, and financial penalties, have proven unsuccessful, she said.

Dr. Coe and her colleagues, including senior investigator Dr. Michael B. Wallace, designed a prospective, randomized educational intervention to determine whether targeted endoscopist training would increase polyp detection rates.

"This is the first study to our knowledge to prospectively show that adenoma detection rate can be significantly improved through an intensive, structured endoscopist training program," Dr. Coe said.

In the first phase of the study, the endoscopists performed 1,200 colonoscopies to determine their baseline detection rates. The average baseline rate was 36% among endoscopists randomized to both the training and non-training groups.

In the second phase of the study, the endoscopists performed another 1,200 colonoscopies after half of them had completed the training program. Among endoscopists in the training group, the average adenoma detection rate increased significantly to 47%, compared to 35% in the non-training group.

The Endoscopic Quality Improvement Program consisted of two 1-hour small group sessions. The first session included literature, photo, and video examples of polyps, explanations of techniques from high-detecting endoscopists, and information about subtle lesions such as flat and serrated polyps.

The second session consisted of a validated surface pattern recognition exercise. The participants in the training program received monthly feedback on their adenoma detection rates, withdrawal times, and group averages after completing the program.

The baseline characteristics of the endoscopists who underwent training and those who did not were similar overall. Median age in the trained and untrained groups was 45 years and 50 years, respectively.

Dr. Coe noted that the findings were limited by the small number of endoscopists and the single setting, but the study is ongoing to see whether the improvements associated with training persist. Larger studies are also planned, she said.

Dr. Coe said she had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Polyp detection rates were significantly higher among endoscopists who completed a quality-improvement training program, compared with rates of those who did not in a randomized, controlled trial of 15 endoscopists and 2,400 procedures. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenoma detection rate is a key quality indicator for colonoscopy, and previous studies have shown associations between physicians’ behavior (such as looking behind folds, and the time spent inspecting the colon) and rates of adenoma detection, said Dr. Susan Coe of the Mayo Clinic in Jacksonville, Fla.

However, attempts at improving polyp detection rates, including discussions with low-performing physicians, required withdrawal times, and financial penalties, have proven unsuccessful, she said.

Dr. Coe and her colleagues, including senior investigator Dr. Michael B. Wallace, designed a prospective, randomized educational intervention to determine whether targeted endoscopist training would increase polyp detection rates.

"This is the first study to our knowledge to prospectively show that adenoma detection rate can be significantly improved through an intensive, structured endoscopist training program," Dr. Coe said.

In the first phase of the study, the endoscopists performed 1,200 colonoscopies to determine their baseline detection rates. The average baseline rate was 36% among endoscopists randomized to both the training and non-training groups.

In the second phase of the study, the endoscopists performed another 1,200 colonoscopies after half of them had completed the training program. Among endoscopists in the training group, the average adenoma detection rate increased significantly to 47%, compared to 35% in the non-training group.

The Endoscopic Quality Improvement Program consisted of two 1-hour small group sessions. The first session included literature, photo, and video examples of polyps, explanations of techniques from high-detecting endoscopists, and information about subtle lesions such as flat and serrated polyps.

The second session consisted of a validated surface pattern recognition exercise. The participants in the training program received monthly feedback on their adenoma detection rates, withdrawal times, and group averages after completing the program.

The baseline characteristics of the endoscopists who underwent training and those who did not were similar overall. Median age in the trained and untrained groups was 45 years and 50 years, respectively.

Dr. Coe noted that the findings were limited by the small number of endoscopists and the single setting, but the study is ongoing to see whether the improvements associated with training persist. Larger studies are also planned, she said.

Dr. Coe said she had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – A screening colonoscopy can provide a convenient opportunity to simultaneously test older adults for hepatitis, based on a study of 500 patients, 75% of whom agreed to blood tests for hepatitis A, B, and C.

Adults aged 50-65 years (the "baby boomers") represent a high-risk population for hepatitis, and hepatitis C in particular, because of possible exposure to high-risk activities in their teens and twenties, said Dr. Dawn Sears of Scott & White Hospital in Temple, Tex. The findings were presented at the annual meeting of the American College of Gastroenterology.

Men make up 70% of chronic hepatitis cases, and they are less likely to see a doctor regularly than women, she noted. "Colorectal cancer screenings are often the only physician encounter for men aged 50 to 60 years," she said.

To increase hepatitis screening in older adults, Dr. Sears and her colleagues tested whether combining hepatitis testing with routine colonoscopy appointments would be effective.

Patients were mailed information about hepatitis along with their instructions for colonoscopy preparation. On the day of their colonoscopies, patients met with a research nurse, signed a consent form, and completed a patient risk form. Blood was drawn for hepatitis screening when the IV was placed prior to the colonoscopy.

A total of 376 of 500 patients (75%) undergoing colonoscopies agreed to hepatitis testing. The study population was 42% male and 58% female. Risk factors in the patients’ histories included high-risk sexual activity, getting a tattoo prior to the year 2000, injecting or snorting drugs, having a blood transfusion before 1992, having a sexual partner with known hepatitis, being a health care worker who had been stuck with a needle, and spending at least 2 days in jail.

None of the patients had hepatitis B surface antigens, and 77% did not have antibodies against hepatitis A and B. Four patients had results suggesting previously undiagnosed hepatitis C, and all four complied with the recommended follow-up polymerase chain reaction (PCR) testing. One patient had a positive PCR follow-up, and that patient is beginning triple therapy, Dr. Sears said. All patients who were found to have hepatitis C antibodies had risk factors for hepatitis C infection, she noted.

"We should ask about risk factors and consider screening for hepatitis B and C," Dr. Sears said. "Gastroenterologists see most baby boomers at least once. We understand the [test] results, and this provides the highest quality, most efficient health care for our patients."

Dr. Sears said she had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – A screening colonoscopy can provide a convenient opportunity to simultaneously test older adults for hepatitis, based on a study of 500 patients, 75% of whom agreed to blood tests for hepatitis A, B, and C.

Adults aged 50-65 years (the "baby boomers") represent a high-risk population for hepatitis, and hepatitis C in particular, because of possible exposure to high-risk activities in their teens and twenties, said Dr. Dawn Sears of Scott & White Hospital in Temple, Tex. The findings were presented at the annual meeting of the American College of Gastroenterology.

Men make up 70% of chronic hepatitis cases, and they are less likely to see a doctor regularly than women, she noted. "Colorectal cancer screenings are often the only physician encounter for men aged 50 to 60 years," she said.

To increase hepatitis screening in older adults, Dr. Sears and her colleagues tested whether combining hepatitis testing with routine colonoscopy appointments would be effective.

Patients were mailed information about hepatitis along with their instructions for colonoscopy preparation. On the day of their colonoscopies, patients met with a research nurse, signed a consent form, and completed a patient risk form. Blood was drawn for hepatitis screening when the IV was placed prior to the colonoscopy.

A total of 376 of 500 patients (75%) undergoing colonoscopies agreed to hepatitis testing. The study population was 42% male and 58% female. Risk factors in the patients’ histories included high-risk sexual activity, getting a tattoo prior to the year 2000, injecting or snorting drugs, having a blood transfusion before 1992, having a sexual partner with known hepatitis, being a health care worker who had been stuck with a needle, and spending at least 2 days in jail.

None of the patients had hepatitis B surface antigens, and 77% did not have antibodies against hepatitis A and B. Four patients had results suggesting previously undiagnosed hepatitis C, and all four complied with the recommended follow-up polymerase chain reaction (PCR) testing. One patient had a positive PCR follow-up, and that patient is beginning triple therapy, Dr. Sears said. All patients who were found to have hepatitis C antibodies had risk factors for hepatitis C infection, she noted.

"We should ask about risk factors and consider screening for hepatitis B and C," Dr. Sears said. "Gastroenterologists see most baby boomers at least once. We understand the [test] results, and this provides the highest quality, most efficient health care for our patients."

Dr. Sears said she had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – A screening colonoscopy can provide a convenient opportunity to simultaneously test older adults for hepatitis, based on a study of 500 patients, 75% of whom agreed to blood tests for hepatitis A, B, and C.

Adults aged 50-65 years (the "baby boomers") represent a high-risk population for hepatitis, and hepatitis C in particular, because of possible exposure to high-risk activities in their teens and twenties, said Dr. Dawn Sears of Scott & White Hospital in Temple, Tex. The findings were presented at the annual meeting of the American College of Gastroenterology.

Men make up 70% of chronic hepatitis cases, and they are less likely to see a doctor regularly than women, she noted. "Colorectal cancer screenings are often the only physician encounter for men aged 50 to 60 years," she said.

To increase hepatitis screening in older adults, Dr. Sears and her colleagues tested whether combining hepatitis testing with routine colonoscopy appointments would be effective.

Patients were mailed information about hepatitis along with their instructions for colonoscopy preparation. On the day of their colonoscopies, patients met with a research nurse, signed a consent form, and completed a patient risk form. Blood was drawn for hepatitis screening when the IV was placed prior to the colonoscopy.

A total of 376 of 500 patients (75%) undergoing colonoscopies agreed to hepatitis testing. The study population was 42% male and 58% female. Risk factors in the patients’ histories included high-risk sexual activity, getting a tattoo prior to the year 2000, injecting or snorting drugs, having a blood transfusion before 1992, having a sexual partner with known hepatitis, being a health care worker who had been stuck with a needle, and spending at least 2 days in jail.

None of the patients had hepatitis B surface antigens, and 77% did not have antibodies against hepatitis A and B. Four patients had results suggesting previously undiagnosed hepatitis C, and all four complied with the recommended follow-up polymerase chain reaction (PCR) testing. One patient had a positive PCR follow-up, and that patient is beginning triple therapy, Dr. Sears said. All patients who were found to have hepatitis C antibodies had risk factors for hepatitis C infection, she noted.

"We should ask about risk factors and consider screening for hepatitis B and C," Dr. Sears said. "Gastroenterologists see most baby boomers at least once. We understand the [test] results, and this provides the highest quality, most efficient health care for our patients."

Dr. Sears said she had no financial conflicts to disclose.

CHICAGO – The shingles vaccine does not increase the risk of shingles in patients taking biologics for autoimmune or inflammatory conditions, based on data from more than 7,000 adults. The findings were presented at the annual meeting of the American College of Rheumatology.

The findings suggest that the current recommendations that biologics users avoid live virus vaccines may be overly cautious, said Dr. Jeffrey R. Curtis of the University of Alabama, Birmingham.

The shingles vaccine (Zostavax) is recommended to protect older adults against herpes zoster, Dr. Curtis said, but concerns have been raised that reactivation of the live virus after vaccination for patients taking immunosuppressive medications might increase their risk of a shingles eruption.

To determine the risk of shingles in a population taking immunosuppressive medication, Dr. Curtis and his colleagues reviewed Medicare data from 2006 to 2009. They identified 7,781 adults aged 60 years and older who had rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease, and who had received a shingles vaccine while taking medication including biologics, disease modifying antirheumatic drugs (DMARDs), and oral glucocorticoids. The mean age of the study population was 74 years, most were white women, and none had any evidence of shingles infection at baseline.

Overall, the incidence rate for shingles at least 42 days after vaccination was 8 cases/1,000 person-years among vaccinated adults, compared with 12 cases/1,000 person-years in a cohort of unvaccinated adults.

In a subset of 636 vaccinated adults who were taking biologics (regardless of concomitant DMARDs or oral glucocorticoids), no cases of shingles were reported within the first 42 days after vaccination, Dr. Curtis emphasized. In fact, vaccination was associated with a decrease in herpes zoster incidence of approximately 30%, he added. By contrast, the incidence rate of shingles in unvaccinated patients taking biologics was 16 per 1,000 person-years. The incidence of infection was not significantly different in vaccinated patients taking biologics than in vaccinated patients taking non-biologic DMARDs, Dr. Curtis added.

The study was limited by the lack of information about the disease severity, Dr. Curtis noted. But the findings support the safety and effectiveness of the shingles vaccine for biologics users.

There are persistent unmet vaccination needs for patients with diseases that require immunosuppressive therapy, said Dr. Curtis. "A controlled safety trial of the zoster vaccine in biologic users may be indicated to further demonstrate its safety and effectiveness in preventing zoster infection," he said.

The study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Curtis has received research grants and consulting fees from Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, Merck, Roche, and UCB.

CHICAGO – The shingles vaccine does not increase the risk of shingles in patients taking biologics for autoimmune or inflammatory conditions, based on data from more than 7,000 adults. The findings were presented at the annual meeting of the American College of Rheumatology.

The findings suggest that the current recommendations that biologics users avoid live virus vaccines may be overly cautious, said Dr. Jeffrey R. Curtis of the University of Alabama, Birmingham.

The shingles vaccine (Zostavax) is recommended to protect older adults against herpes zoster, Dr. Curtis said, but concerns have been raised that reactivation of the live virus after vaccination for patients taking immunosuppressive medications might increase their risk of a shingles eruption.

To determine the risk of shingles in a population taking immunosuppressive medication, Dr. Curtis and his colleagues reviewed Medicare data from 2006 to 2009. They identified 7,781 adults aged 60 years and older who had rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease, and who had received a shingles vaccine while taking medication including biologics, disease modifying antirheumatic drugs (DMARDs), and oral glucocorticoids. The mean age of the study population was 74 years, most were white women, and none had any evidence of shingles infection at baseline.

Overall, the incidence rate for shingles at least 42 days after vaccination was 8 cases/1,000 person-years among vaccinated adults, compared with 12 cases/1,000 person-years in a cohort of unvaccinated adults.

In a subset of 636 vaccinated adults who were taking biologics (regardless of concomitant DMARDs or oral glucocorticoids), no cases of shingles were reported within the first 42 days after vaccination, Dr. Curtis emphasized. In fact, vaccination was associated with a decrease in herpes zoster incidence of approximately 30%, he added. By contrast, the incidence rate of shingles in unvaccinated patients taking biologics was 16 per 1,000 person-years. The incidence of infection was not significantly different in vaccinated patients taking biologics than in vaccinated patients taking non-biologic DMARDs, Dr. Curtis added.

The study was limited by the lack of information about the disease severity, Dr. Curtis noted. But the findings support the safety and effectiveness of the shingles vaccine for biologics users.

There are persistent unmet vaccination needs for patients with diseases that require immunosuppressive therapy, said Dr. Curtis. "A controlled safety trial of the zoster vaccine in biologic users may be indicated to further demonstrate its safety and effectiveness in preventing zoster infection," he said.

The study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Curtis has received research grants and consulting fees from Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, Merck, Roche, and UCB.

CHICAGO – The shingles vaccine does not increase the risk of shingles in patients taking biologics for autoimmune or inflammatory conditions, based on data from more than 7,000 adults. The findings were presented at the annual meeting of the American College of Rheumatology.

The findings suggest that the current recommendations that biologics users avoid live virus vaccines may be overly cautious, said Dr. Jeffrey R. Curtis of the University of Alabama, Birmingham.

The shingles vaccine (Zostavax) is recommended to protect older adults against herpes zoster, Dr. Curtis said, but concerns have been raised that reactivation of the live virus after vaccination for patients taking immunosuppressive medications might increase their risk of a shingles eruption.

To determine the risk of shingles in a population taking immunosuppressive medication, Dr. Curtis and his colleagues reviewed Medicare data from 2006 to 2009. They identified 7,781 adults aged 60 years and older who had rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease, and who had received a shingles vaccine while taking medication including biologics, disease modifying antirheumatic drugs (DMARDs), and oral glucocorticoids. The mean age of the study population was 74 years, most were white women, and none had any evidence of shingles infection at baseline.

Overall, the incidence rate for shingles at least 42 days after vaccination was 8 cases/1,000 person-years among vaccinated adults, compared with 12 cases/1,000 person-years in a cohort of unvaccinated adults.

In a subset of 636 vaccinated adults who were taking biologics (regardless of concomitant DMARDs or oral glucocorticoids), no cases of shingles were reported within the first 42 days after vaccination, Dr. Curtis emphasized. In fact, vaccination was associated with a decrease in herpes zoster incidence of approximately 30%, he added. By contrast, the incidence rate of shingles in unvaccinated patients taking biologics was 16 per 1,000 person-years. The incidence of infection was not significantly different in vaccinated patients taking biologics than in vaccinated patients taking non-biologic DMARDs, Dr. Curtis added.

The study was limited by the lack of information about the disease severity, Dr. Curtis noted. But the findings support the safety and effectiveness of the shingles vaccine for biologics users.

There are persistent unmet vaccination needs for patients with diseases that require immunosuppressive therapy, said Dr. Curtis. "A controlled safety trial of the zoster vaccine in biologic users may be indicated to further demonstrate its safety and effectiveness in preventing zoster infection," he said.

The study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Curtis has received research grants and consulting fees from Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, Merck, Roche, and UCB.

Perhaps the best news about the cholesterol testing now recommended for all children aged 9-11 years by an expert panel convened by the National Heart, Lung, and Blood Institute is that children don’t have to fast before getting their blood drawn. The guidelines were published online on Nov. 13 and appear in the December issue of Pediatrics.

Dr. Stephen R. Daniels, chair of the expert panel that reviewed the guidelines, emphasized that the new approach to cholesterol screening can be accomplished with a blood test that does not require fasting, so it should be relatively easy to include in a busy practice. This strategy "ensures that children with elevated LDL (or bad) cholesterol will be identified."

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Daniels, pediatrician-in-chief at the University of Colorado at Denver, Aurora.

Data from previous studies have shown that atherosclerosis begins in youth, and that heart attacks, strokes, and other cardiovascular problems in adulthood are often the end result of cardiovascular risk factors that went unrecognized throughout childhood, according to the report (Pediatrics 2011 Nov. 13 [doi:10.1542/peds.2009-2107C]).

The current guidelines represent the latest update since the 1990s, said Dr. Daniels.

"These guidelines are different in that they are based on a comprehensive and systematic review of the literature, they are integrated across all risk factors (hypertension, dyslipidemia, obesity, diabetes, and cigarette smoking) and lifestyle factors (diet and physical activity), and they address issues across the pediatric age range," he said in an interview.

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Stephen R. Daniels.

The "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents Summary Report" provides details for how to reduce risk factors and help prevent cardiovascular problems in children from birth to 21 years of age, starting with a recommendation for exclusive breastfeeding of children for the first 6 months of life.

However, the most notable new element in the guidelines is universal cholesterol-screening recommendation for preadolescents.

According to the guidelines, doctors should obtain a universal lipid screen with nonfasting non-HDL cholesterol (that is, total cholesterol minus HDL cholesterol) or a fasting lipid profile (FLP) for all children at least once between the ages of 9 and 11 years, and "manage per lipid algorithms as needed." Diet and exercise are recommended as first-line treatment, but statins may be considered in children whose high cholesterol persists despite diet and lifestyle interventions.

The guidelines recommend obtaining an FLP at age 12-17 years if a child’s family history is newly positive, if a parent has dyslipidemia, or if the child has any other risk factors or high-risk conditions, and then managing per lipid algorithms as needed.

For all patients aged 18-21 years, the guidelines recommend measuring one nonfasting non-HDL or FLP, and then reviewing the results with patients and managing them with lipid algorithms per Adult Treatment Panel III as needed.

Preventive steps to reduce risk and prevent cardiovascular disease in all ages include regular physical activity, with vigorous activity 3 days a week, according to the "Physical Activity Guidelines Advisory Committee Report 2008" from the Department of Health and Human Services.

Other preventive measures include a diet low in saturated fat for all children starting at 1 year of age, as well as both practice- and school-based interventions to keep children from smoking and to help them quit.

The guidelines also recommend annual blood pressure measurement for all children starting at 3 years of age, and interpreted for age, sex, and height. The report has a chart with an algorithm and flow diagram to assist clinicians in diagnosing hypertension in children.

"The rationale for these guidelines is that there is more and more evidence for the concept that atherosclerosis begins in childhood and depends on the same risk factors we are concerned about in adults," Dr. Daniels said. "This means that we should try to prevent these risk factors from developing in the first place (primordial prevention) and identify children at higher risk, so we can work on improving their lifestyle," he added.

"Cardiovascular disease is the most common cause of death for both men and women. So, this places great importance on these issues for primary care pediatricians. The new approach to screening may actually be easier to implement than the old strategy, which requires constant updating of the family history," noted Dr. Daniels, who is also chairman and professor of pediatrics at the university.

"This test should be done once for every child in the 9- to 11-year age range. The universal approach to screening will identify children with a genetic cause for their high cholesterol (1 in 500 children) and children with cholesterol abnormalities based more on lifestyle," said Dr. Daniels. "Both groups will benefit from lifestyle intervention, which can be useful in lowering their lifetime risk of cardiovascular disease."

Dr. Daniels has served as a consultant for Abbott Laboratories, Merck, and Schering-Plough, and has received funding/grant support for research from the National Institutes of Health. Other members of the committee that reviewed the guidelines disclosed research support from various agencies and pharmaceutical companies.

Perhaps the best news about the cholesterol testing now recommended for all children aged 9-11 years by an expert panel convened by the National Heart, Lung, and Blood Institute is that children don’t have to fast before getting their blood drawn. The guidelines were published online on Nov. 13 and appear in the December issue of Pediatrics.

Dr. Stephen R. Daniels, chair of the expert panel that reviewed the guidelines, emphasized that the new approach to cholesterol screening can be accomplished with a blood test that does not require fasting, so it should be relatively easy to include in a busy practice. This strategy "ensures that children with elevated LDL (or bad) cholesterol will be identified."

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Daniels, pediatrician-in-chief at the University of Colorado at Denver, Aurora.

Data from previous studies have shown that atherosclerosis begins in youth, and that heart attacks, strokes, and other cardiovascular problems in adulthood are often the end result of cardiovascular risk factors that went unrecognized throughout childhood, according to the report (Pediatrics 2011 Nov. 13 [doi:10.1542/peds.2009-2107C]).

The current guidelines represent the latest update since the 1990s, said Dr. Daniels.

"These guidelines are different in that they are based on a comprehensive and systematic review of the literature, they are integrated across all risk factors (hypertension, dyslipidemia, obesity, diabetes, and cigarette smoking) and lifestyle factors (diet and physical activity), and they address issues across the pediatric age range," he said in an interview.

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Stephen R. Daniels.

The "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents Summary Report" provides details for how to reduce risk factors and help prevent cardiovascular problems in children from birth to 21 years of age, starting with a recommendation for exclusive breastfeeding of children for the first 6 months of life.

However, the most notable new element in the guidelines is universal cholesterol-screening recommendation for preadolescents.

According to the guidelines, doctors should obtain a universal lipid screen with nonfasting non-HDL cholesterol (that is, total cholesterol minus HDL cholesterol) or a fasting lipid profile (FLP) for all children at least once between the ages of 9 and 11 years, and "manage per lipid algorithms as needed." Diet and exercise are recommended as first-line treatment, but statins may be considered in children whose high cholesterol persists despite diet and lifestyle interventions.

The guidelines recommend obtaining an FLP at age 12-17 years if a child’s family history is newly positive, if a parent has dyslipidemia, or if the child has any other risk factors or high-risk conditions, and then managing per lipid algorithms as needed.

For all patients aged 18-21 years, the guidelines recommend measuring one nonfasting non-HDL or FLP, and then reviewing the results with patients and managing them with lipid algorithms per Adult Treatment Panel III as needed.

Preventive steps to reduce risk and prevent cardiovascular disease in all ages include regular physical activity, with vigorous activity 3 days a week, according to the "Physical Activity Guidelines Advisory Committee Report 2008" from the Department of Health and Human Services.

Other preventive measures include a diet low in saturated fat for all children starting at 1 year of age, as well as both practice- and school-based interventions to keep children from smoking and to help them quit.

The guidelines also recommend annual blood pressure measurement for all children starting at 3 years of age, and interpreted for age, sex, and height. The report has a chart with an algorithm and flow diagram to assist clinicians in diagnosing hypertension in children.

"The rationale for these guidelines is that there is more and more evidence for the concept that atherosclerosis begins in childhood and depends on the same risk factors we are concerned about in adults," Dr. Daniels said. "This means that we should try to prevent these risk factors from developing in the first place (primordial prevention) and identify children at higher risk, so we can work on improving their lifestyle," he added.

"Cardiovascular disease is the most common cause of death for both men and women. So, this places great importance on these issues for primary care pediatricians. The new approach to screening may actually be easier to implement than the old strategy, which requires constant updating of the family history," noted Dr. Daniels, who is also chairman and professor of pediatrics at the university.

"This test should be done once for every child in the 9- to 11-year age range. The universal approach to screening will identify children with a genetic cause for their high cholesterol (1 in 500 children) and children with cholesterol abnormalities based more on lifestyle," said Dr. Daniels. "Both groups will benefit from lifestyle intervention, which can be useful in lowering their lifetime risk of cardiovascular disease."

Dr. Daniels has served as a consultant for Abbott Laboratories, Merck, and Schering-Plough, and has received funding/grant support for research from the National Institutes of Health. Other members of the committee that reviewed the guidelines disclosed research support from various agencies and pharmaceutical companies.

Perhaps the best news about the cholesterol testing now recommended for all children aged 9-11 years by an expert panel convened by the National Heart, Lung, and Blood Institute is that children don’t have to fast before getting their blood drawn. The guidelines were published online on Nov. 13 and appear in the December issue of Pediatrics.

Dr. Stephen R. Daniels, chair of the expert panel that reviewed the guidelines, emphasized that the new approach to cholesterol screening can be accomplished with a blood test that does not require fasting, so it should be relatively easy to include in a busy practice. This strategy "ensures that children with elevated LDL (or bad) cholesterol will be identified."

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Daniels, pediatrician-in-chief at the University of Colorado at Denver, Aurora.

Data from previous studies have shown that atherosclerosis begins in youth, and that heart attacks, strokes, and other cardiovascular problems in adulthood are often the end result of cardiovascular risk factors that went unrecognized throughout childhood, according to the report (Pediatrics 2011 Nov. 13 [doi:10.1542/peds.2009-2107C]).

The current guidelines represent the latest update since the 1990s, said Dr. Daniels.

"These guidelines are different in that they are based on a comprehensive and systematic review of the literature, they are integrated across all risk factors (hypertension, dyslipidemia, obesity, diabetes, and cigarette smoking) and lifestyle factors (diet and physical activity), and they address issues across the pediatric age range," he said in an interview.

Data from studies of the previous cholesterol-screening approach suggest that children with high cholesterol have often been missed, said Dr. Stephen R. Daniels.

The "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents Summary Report" provides details for how to reduce risk factors and help prevent cardiovascular problems in children from birth to 21 years of age, starting with a recommendation for exclusive breastfeeding of children for the first 6 months of life.

However, the most notable new element in the guidelines is universal cholesterol-screening recommendation for preadolescents.

According to the guidelines, doctors should obtain a universal lipid screen with nonfasting non-HDL cholesterol (that is, total cholesterol minus HDL cholesterol) or a fasting lipid profile (FLP) for all children at least once between the ages of 9 and 11 years, and "manage per lipid algorithms as needed." Diet and exercise are recommended as first-line treatment, but statins may be considered in children whose high cholesterol persists despite diet and lifestyle interventions.

The guidelines recommend obtaining an FLP at age 12-17 years if a child’s family history is newly positive, if a parent has dyslipidemia, or if the child has any other risk factors or high-risk conditions, and then managing per lipid algorithms as needed.

For all patients aged 18-21 years, the guidelines recommend measuring one nonfasting non-HDL or FLP, and then reviewing the results with patients and managing them with lipid algorithms per Adult Treatment Panel III as needed.

Preventive steps to reduce risk and prevent cardiovascular disease in all ages include regular physical activity, with vigorous activity 3 days a week, according to the "Physical Activity Guidelines Advisory Committee Report 2008" from the Department of Health and Human Services.

Other preventive measures include a diet low in saturated fat for all children starting at 1 year of age, as well as both practice- and school-based interventions to keep children from smoking and to help them quit.

The guidelines also recommend annual blood pressure measurement for all children starting at 3 years of age, and interpreted for age, sex, and height. The report has a chart with an algorithm and flow diagram to assist clinicians in diagnosing hypertension in children.

"The rationale for these guidelines is that there is more and more evidence for the concept that atherosclerosis begins in childhood and depends on the same risk factors we are concerned about in adults," Dr. Daniels said. "This means that we should try to prevent these risk factors from developing in the first place (primordial prevention) and identify children at higher risk, so we can work on improving their lifestyle," he added.

"Cardiovascular disease is the most common cause of death for both men and women. So, this places great importance on these issues for primary care pediatricians. The new approach to screening may actually be easier to implement than the old strategy, which requires constant updating of the family history," noted Dr. Daniels, who is also chairman and professor of pediatrics at the university.

"This test should be done once for every child in the 9- to 11-year age range. The universal approach to screening will identify children with a genetic cause for their high cholesterol (1 in 500 children) and children with cholesterol abnormalities based more on lifestyle," said Dr. Daniels. "Both groups will benefit from lifestyle intervention, which can be useful in lowering their lifetime risk of cardiovascular disease."

Dr. Daniels has served as a consultant for Abbott Laboratories, Merck, and Schering-Plough, and has received funding/grant support for research from the National Institutes of Health. Other members of the committee that reviewed the guidelines disclosed research support from various agencies and pharmaceutical companies.

NATIONAL HARBOR, MD. – Endoscopists using the water-infusion method of screening colonoscopy found significantly more adenomas if they added indigo dye, compared with the water method alone, a new study has shown.

"Indigo carmine enhances any surface irregularities" when used as part of screening colonoscopies, Dr. Joseph W. Leung said in a late-breaking abstract session at the annual meeting of the American College of Gastroenterology.

Indigo carmine is used to enhance adenoma detection in chromoendoscopy, which is a more cumbersome process than the water method, Dr. Leung said. He and his colleagues conducted a randomized, controlled trial to assess the value of adding indigo carmine to the water method. The protocol was to add 10 mL 0.8% indigo carmine per 1 liter of water (0.008% indigo carmine).

A total of 84 patients were randomized to screening colonoscopies via the water method alone, and another 84 were randomized to the water method with indigo carmine. The mean age of the patients was 58 years, and more than 75% of patients in each group were men. Body mass index and family history of colon cancer were similar in the two groups, but the indigo carmine group included significantly more smokers than the water-method-only group.

Overall, the adenoma detection rate was 62% in the water-plus-indigo carmine group, compared with 44% in the water-only group, and this difference was statistically significant (P = .03). One cancer was detected in each group.

The colonoscopies were performed by two endoscopists who had experience with both methods, noted Dr. Leung of the Sacramento VA Medical Center in Mather, Calif. Patients were blinded as to which procedure they had, and all patients underwent intravenous conscious sedation.

In both groups, air was suctioned out of the rectum when a high-resolution colonoscope was inserted. Water was infused, and any residual stool or cloudiness was suctioned out, followed by another infusion of clear water. "Water infusion and suction was done in rapid sequence," Dr. Leung said.

"Upon seeing the appendix opening under water, water was suctioned and air was insufflated to facilitate inspection on scope withdrawal," he added.

Dr. Leung offered several possible explanations for the increased adenoma detection rate when indigo carmine was added to the water method.

"The water exchange minimizes residual water and allows undistracted examination during withdrawal," he said. The addition of indigo carmine dye enhances the contrast between a lesion and the surrounding mucosa, which improves polyp detection, he noted. Also, the water method offers improved visualization, and the warm water may reduce spasm in the colon, he added.

The study was supported in part by clinical research grants from the American Society for Gastrointestinal Endoscopy and the American College of Gastroenterology. Dr. Leung had no personal financial disclosures.

NATIONAL HARBOR, MD. – Endoscopists using the water-infusion method of screening colonoscopy found significantly more adenomas if they added indigo dye, compared with the water method alone, a new study has shown.

"Indigo carmine enhances any surface irregularities" when used as part of screening colonoscopies, Dr. Joseph W. Leung said in a late-breaking abstract session at the annual meeting of the American College of Gastroenterology.

Indigo carmine is used to enhance adenoma detection in chromoendoscopy, which is a more cumbersome process than the water method, Dr. Leung said. He and his colleagues conducted a randomized, controlled trial to assess the value of adding indigo carmine to the water method. The protocol was to add 10 mL 0.8% indigo carmine per 1 liter of water (0.008% indigo carmine).

A total of 84 patients were randomized to screening colonoscopies via the water method alone, and another 84 were randomized to the water method with indigo carmine. The mean age of the patients was 58 years, and more than 75% of patients in each group were men. Body mass index and family history of colon cancer were similar in the two groups, but the indigo carmine group included significantly more smokers than the water-method-only group.

Overall, the adenoma detection rate was 62% in the water-plus-indigo carmine group, compared with 44% in the water-only group, and this difference was statistically significant (P = .03). One cancer was detected in each group.

The colonoscopies were performed by two endoscopists who had experience with both methods, noted Dr. Leung of the Sacramento VA Medical Center in Mather, Calif. Patients were blinded as to which procedure they had, and all patients underwent intravenous conscious sedation.

In both groups, air was suctioned out of the rectum when a high-resolution colonoscope was inserted. Water was infused, and any residual stool or cloudiness was suctioned out, followed by another infusion of clear water. "Water infusion and suction was done in rapid sequence," Dr. Leung said.

"Upon seeing the appendix opening under water, water was suctioned and air was insufflated to facilitate inspection on scope withdrawal," he added.

Dr. Leung offered several possible explanations for the increased adenoma detection rate when indigo carmine was added to the water method.

"The water exchange minimizes residual water and allows undistracted examination during withdrawal," he said. The addition of indigo carmine dye enhances the contrast between a lesion and the surrounding mucosa, which improves polyp detection, he noted. Also, the water method offers improved visualization, and the warm water may reduce spasm in the colon, he added.

The study was supported in part by clinical research grants from the American Society for Gastrointestinal Endoscopy and the American College of Gastroenterology. Dr. Leung had no personal financial disclosures.

NATIONAL HARBOR, MD. – Endoscopists using the water-infusion method of screening colonoscopy found significantly more adenomas if they added indigo dye, compared with the water method alone, a new study has shown.

"Indigo carmine enhances any surface irregularities" when used as part of screening colonoscopies, Dr. Joseph W. Leung said in a late-breaking abstract session at the annual meeting of the American College of Gastroenterology.

Indigo carmine is used to enhance adenoma detection in chromoendoscopy, which is a more cumbersome process than the water method, Dr. Leung said. He and his colleagues conducted a randomized, controlled trial to assess the value of adding indigo carmine to the water method. The protocol was to add 10 mL 0.8% indigo carmine per 1 liter of water (0.008% indigo carmine).

A total of 84 patients were randomized to screening colonoscopies via the water method alone, and another 84 were randomized to the water method with indigo carmine. The mean age of the patients was 58 years, and more than 75% of patients in each group were men. Body mass index and family history of colon cancer were similar in the two groups, but the indigo carmine group included significantly more smokers than the water-method-only group.

Overall, the adenoma detection rate was 62% in the water-plus-indigo carmine group, compared with 44% in the water-only group, and this difference was statistically significant (P = .03). One cancer was detected in each group.

The colonoscopies were performed by two endoscopists who had experience with both methods, noted Dr. Leung of the Sacramento VA Medical Center in Mather, Calif. Patients were blinded as to which procedure they had, and all patients underwent intravenous conscious sedation.

In both groups, air was suctioned out of the rectum when a high-resolution colonoscope was inserted. Water was infused, and any residual stool or cloudiness was suctioned out, followed by another infusion of clear water. "Water infusion and suction was done in rapid sequence," Dr. Leung said.

"Upon seeing the appendix opening under water, water was suctioned and air was insufflated to facilitate inspection on scope withdrawal," he added.

Dr. Leung offered several possible explanations for the increased adenoma detection rate when indigo carmine was added to the water method.

"The water exchange minimizes residual water and allows undistracted examination during withdrawal," he said. The addition of indigo carmine dye enhances the contrast between a lesion and the surrounding mucosa, which improves polyp detection, he noted. Also, the water method offers improved visualization, and the warm water may reduce spasm in the colon, he added.

The study was supported in part by clinical research grants from the American Society for Gastrointestinal Endoscopy and the American College of Gastroenterology. Dr. Leung had no personal financial disclosures.