NATIONAL HARBOR, MD. – Colonoscopy led to significant reductions in colorectal cancers located in both the distal colon and proximal colon, based on a large analysis of Medicare data from 1998 to 2002.

The finding that colonoscopy provided protection in the proximal colon is important because "several recent studies [have] yielded mixed results on the protective effect of colonoscopy in the proximal colon," said Dr. Yize Wang of the Mayo Clinic in Jacksonville, Fla.

To assess the impact of colonoscopy and flexible sigmoidoscopy on colorectal cancer risk, Dr. Wang and colleagues analyzed cancer rates in adults aged 67 to 80 years. The study group included 12,266 patients who had an outpatient colonoscopy, 6,402 who underwent sigmoidoscopy, and 41,410 individuals who did not have a screening procedure and served as controls.

Patients with inflammatory bowel disease, a history of polyps, or a history of colorectal cancer were excluded. The study patients were followed until the end of 2005, or until a diagnosis of colorectal cancer, or death.

A total of 58 colorectal cancers (CRCs) were diagnosed in the colonoscopy group during the follow-up period, compared to 66 CRCs in the patients who underwent flexible sigmoidoscopy and 634 CRCs in the control group.

In a multivariate analysis, colonoscopy was associated with a significant 73% reduction of distal colorectal cancer (hazard ratio, 0.27) and a significant 54% reduction of proximal colorectal cancer (HR, 0.46), compared with unscreened controls.

Sigmoidoscopy was associated with a significant 60% reduction of distal colorectal cancer (HR, 0.40), but no significant reduction in proximal colorectal cancer, compared to unscreened controls; this was expected because the procedure does not examine the entire colon.

A total of 771 (12%) of the patients who first underwent sigmoidoscopy went on to have a colonoscopy within 12 months. When the investigators excluded data from these patients, who had sigmoidoscopy followed by colonoscopy, the study results on cancer risk were essentially unchanged.

The findings were limited by the retrospective nature of the study, as well as the confounding effect of the diagnostic procedure chosen and the selection bias in the use of screening endoscopy, Dr. Wang said.

In addition, the study "does not reflect recent advancements in endoscopy equipment and techniques," he noted.

However, the results from this large study population confirm that colonoscopy remains the preferred screening test for colorectal cancer, said Dr. Wang.

The study was funded by a research grant from the American College of Gastroenterology. The researchers said they had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Colonoscopy led to significant reductions in colorectal cancers located in both the distal colon and proximal colon, based on a large analysis of Medicare data from 1998 to 2002.

The finding that colonoscopy provided protection in the proximal colon is important because "several recent studies [have] yielded mixed results on the protective effect of colonoscopy in the proximal colon," said Dr. Yize Wang of the Mayo Clinic in Jacksonville, Fla.

To assess the impact of colonoscopy and flexible sigmoidoscopy on colorectal cancer risk, Dr. Wang and colleagues analyzed cancer rates in adults aged 67 to 80 years. The study group included 12,266 patients who had an outpatient colonoscopy, 6,402 who underwent sigmoidoscopy, and 41,410 individuals who did not have a screening procedure and served as controls.

Patients with inflammatory bowel disease, a history of polyps, or a history of colorectal cancer were excluded. The study patients were followed until the end of 2005, or until a diagnosis of colorectal cancer, or death.

A total of 58 colorectal cancers (CRCs) were diagnosed in the colonoscopy group during the follow-up period, compared to 66 CRCs in the patients who underwent flexible sigmoidoscopy and 634 CRCs in the control group.

In a multivariate analysis, colonoscopy was associated with a significant 73% reduction of distal colorectal cancer (hazard ratio, 0.27) and a significant 54% reduction of proximal colorectal cancer (HR, 0.46), compared with unscreened controls.

Sigmoidoscopy was associated with a significant 60% reduction of distal colorectal cancer (HR, 0.40), but no significant reduction in proximal colorectal cancer, compared to unscreened controls; this was expected because the procedure does not examine the entire colon.

A total of 771 (12%) of the patients who first underwent sigmoidoscopy went on to have a colonoscopy within 12 months. When the investigators excluded data from these patients, who had sigmoidoscopy followed by colonoscopy, the study results on cancer risk were essentially unchanged.

The findings were limited by the retrospective nature of the study, as well as the confounding effect of the diagnostic procedure chosen and the selection bias in the use of screening endoscopy, Dr. Wang said.

In addition, the study "does not reflect recent advancements in endoscopy equipment and techniques," he noted.

However, the results from this large study population confirm that colonoscopy remains the preferred screening test for colorectal cancer, said Dr. Wang.

The study was funded by a research grant from the American College of Gastroenterology. The researchers said they had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Colonoscopy led to significant reductions in colorectal cancers located in both the distal colon and proximal colon, based on a large analysis of Medicare data from 1998 to 2002.

The finding that colonoscopy provided protection in the proximal colon is important because "several recent studies [have] yielded mixed results on the protective effect of colonoscopy in the proximal colon," said Dr. Yize Wang of the Mayo Clinic in Jacksonville, Fla.

To assess the impact of colonoscopy and flexible sigmoidoscopy on colorectal cancer risk, Dr. Wang and colleagues analyzed cancer rates in adults aged 67 to 80 years. The study group included 12,266 patients who had an outpatient colonoscopy, 6,402 who underwent sigmoidoscopy, and 41,410 individuals who did not have a screening procedure and served as controls.

Patients with inflammatory bowel disease, a history of polyps, or a history of colorectal cancer were excluded. The study patients were followed until the end of 2005, or until a diagnosis of colorectal cancer, or death.

A total of 58 colorectal cancers (CRCs) were diagnosed in the colonoscopy group during the follow-up period, compared to 66 CRCs in the patients who underwent flexible sigmoidoscopy and 634 CRCs in the control group.

In a multivariate analysis, colonoscopy was associated with a significant 73% reduction of distal colorectal cancer (hazard ratio, 0.27) and a significant 54% reduction of proximal colorectal cancer (HR, 0.46), compared with unscreened controls.

Sigmoidoscopy was associated with a significant 60% reduction of distal colorectal cancer (HR, 0.40), but no significant reduction in proximal colorectal cancer, compared to unscreened controls; this was expected because the procedure does not examine the entire colon.

A total of 771 (12%) of the patients who first underwent sigmoidoscopy went on to have a colonoscopy within 12 months. When the investigators excluded data from these patients, who had sigmoidoscopy followed by colonoscopy, the study results on cancer risk were essentially unchanged.

The findings were limited by the retrospective nature of the study, as well as the confounding effect of the diagnostic procedure chosen and the selection bias in the use of screening endoscopy, Dr. Wang said.

In addition, the study "does not reflect recent advancements in endoscopy equipment and techniques," he noted.

However, the results from this large study population confirm that colonoscopy remains the preferred screening test for colorectal cancer, said Dr. Wang.

The study was funded by a research grant from the American College of Gastroenterology. The researchers said they had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Coronary artery disease was significantly more prevalent in patients with hepatitis C virus infection, compared with control subjects, based on a retrospective review. The findings were presented at the annual meeting of the American College of Gastroenterology.

"An association of coronary artery disease [CAD] with hepatitis C has been suggested, but definitive data are still lacking," said Dr. Sanjaya Satapathy, who conducted the study while at Long Island Jewish Medical Center in New Hyde Park, N.Y.

To estimate the prevalence of CAD in hepatitis C patients, Dr. Satapathy and his colleagues reviewed data from 934 individuals with hepatitis C infection who were seen at a single center between May 2002 and December 2008. Of these patients, 63 had undergone coronary angiography. The investigators compared their data with data from 63 matched controls without hepatitis C.

Overall severity of CAD according to the combined Reardon severity score was significantly greater in the hepatitis C virus (HCV) group than in the controls (6.3 vs. 2.6, respectively), suggesting that being HCV-positive increases the severity of, or risk for, CAD, Dr. Satapathy said.

The researchers defined CAD in two different ways for their analysis. CAD defined as stenosis greater than 50% was found in 44 of the HCV cases (70%) compared with 30 controls (48%). CAD defined as stenosis greater than 75% was found in 42 patients with hepatitis C (67%) compared with 29 controls (46%).

In addition, the prevalence of multivessel coronary artery disease was significantly higher in the HCV patients compared with the controls (57% vs. 16%, respectively). The prevalence of single-vessel involvement was greater in the control group.

"HCV seropositive status is a strong predictor for CAD," Dr. Satapathy said. However, "HCV patients are more likely to remain undertreated with antiplatelet and lipid-lowering agents," he noted.

The study was limited by the retrospective design and small sample size, said Dr. Satapathy. However, the findings suggest that CAD is significantly more common and severe in HCV-positive patients, and this should be considered by clinicians treating these patients, he said.

Dr. Satapathy said he had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Coronary artery disease was significantly more prevalent in patients with hepatitis C virus infection, compared with control subjects, based on a retrospective review. The findings were presented at the annual meeting of the American College of Gastroenterology.

"An association of coronary artery disease [CAD] with hepatitis C has been suggested, but definitive data are still lacking," said Dr. Sanjaya Satapathy, who conducted the study while at Long Island Jewish Medical Center in New Hyde Park, N.Y.

To estimate the prevalence of CAD in hepatitis C patients, Dr. Satapathy and his colleagues reviewed data from 934 individuals with hepatitis C infection who were seen at a single center between May 2002 and December 2008. Of these patients, 63 had undergone coronary angiography. The investigators compared their data with data from 63 matched controls without hepatitis C.

Overall severity of CAD according to the combined Reardon severity score was significantly greater in the hepatitis C virus (HCV) group than in the controls (6.3 vs. 2.6, respectively), suggesting that being HCV-positive increases the severity of, or risk for, CAD, Dr. Satapathy said.

The researchers defined CAD in two different ways for their analysis. CAD defined as stenosis greater than 50% was found in 44 of the HCV cases (70%) compared with 30 controls (48%). CAD defined as stenosis greater than 75% was found in 42 patients with hepatitis C (67%) compared with 29 controls (46%).

In addition, the prevalence of multivessel coronary artery disease was significantly higher in the HCV patients compared with the controls (57% vs. 16%, respectively). The prevalence of single-vessel involvement was greater in the control group.

"HCV seropositive status is a strong predictor for CAD," Dr. Satapathy said. However, "HCV patients are more likely to remain undertreated with antiplatelet and lipid-lowering agents," he noted.

The study was limited by the retrospective design and small sample size, said Dr. Satapathy. However, the findings suggest that CAD is significantly more common and severe in HCV-positive patients, and this should be considered by clinicians treating these patients, he said.

Dr. Satapathy said he had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Coronary artery disease was significantly more prevalent in patients with hepatitis C virus infection, compared with control subjects, based on a retrospective review. The findings were presented at the annual meeting of the American College of Gastroenterology.

"An association of coronary artery disease [CAD] with hepatitis C has been suggested, but definitive data are still lacking," said Dr. Sanjaya Satapathy, who conducted the study while at Long Island Jewish Medical Center in New Hyde Park, N.Y.

To estimate the prevalence of CAD in hepatitis C patients, Dr. Satapathy and his colleagues reviewed data from 934 individuals with hepatitis C infection who were seen at a single center between May 2002 and December 2008. Of these patients, 63 had undergone coronary angiography. The investigators compared their data with data from 63 matched controls without hepatitis C.

Overall severity of CAD according to the combined Reardon severity score was significantly greater in the hepatitis C virus (HCV) group than in the controls (6.3 vs. 2.6, respectively), suggesting that being HCV-positive increases the severity of, or risk for, CAD, Dr. Satapathy said.

The researchers defined CAD in two different ways for their analysis. CAD defined as stenosis greater than 50% was found in 44 of the HCV cases (70%) compared with 30 controls (48%). CAD defined as stenosis greater than 75% was found in 42 patients with hepatitis C (67%) compared with 29 controls (46%).

In addition, the prevalence of multivessel coronary artery disease was significantly higher in the HCV patients compared with the controls (57% vs. 16%, respectively). The prevalence of single-vessel involvement was greater in the control group.

"HCV seropositive status is a strong predictor for CAD," Dr. Satapathy said. However, "HCV patients are more likely to remain undertreated with antiplatelet and lipid-lowering agents," he noted.

The study was limited by the retrospective design and small sample size, said Dr. Satapathy. However, the findings suggest that CAD is significantly more common and severe in HCV-positive patients, and this should be considered by clinicians treating these patients, he said.

Dr. Satapathy said he had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – "Food is what patients blame for their gastrointestinal symptoms," Dr. Peter Gibson said at the annual meeting of the American College of Gastroenterology.

And patients with functional GI disorders may be on the right track, according to Dr. Gibson, professor of medicine at Monash University in Victoria, Australia. He presented a novel dietary treatment that is not well known in the United States but appears promising as a strategy for managing irritable bowel syndrome (IBS) and other functional GI problems.

(c) Christian Pedant/fotolia.com

Dr. Gibson also said that physicians who want to help their patients manage their symptoms need to understand how foods can interact with the enteric nervous system, which controls most GI functions.

More specifically, certain types of sugars found in many foods are rapidly absorbed and fermented, drawing liquid into the GI tract, which can cause distension and trigger the symptoms of IBS, such as bloating and pain, he said.

The novel dietary approach is known by the acronym FODMAP, which stands for the types of sugars suspected of causing symptoms: fermentable sugars, oligosaccharides, disaccharides, monosaccharides, and polyols (such as sorbitol or mannitol). Thus the regimen designed to reduce symptoms is called a low-FODMAP diet, said Dr. Gibson.

Data are limited, but in theory, a low-FODMAP diet causes less distension of the intestinal lumen and thereby reduces IBS symptoms. His colleague, Susan Shepherd, Ph.D., who is a dietitian, has developed a list of foods that should be included, and others to exclude, when following such a diet.

In a recent study, 82 IBS patients were randomized to receive either standard dietary advice (39 people) or instruction on following a low-FODMAP diet (43 people); the patients were meeting with a dietitian on an outpatient basis (J. Hum. Nutr. Diet 2011;24:487-95).

Composite IBS symptom scores showed that significantly more patients in the low-FODMAP group had overall improvement in their symptoms, compared with the standard care group (86% vs. 49%). In addition, significantly more low-FODMAP patients reported improvements in bloating (82%), abdominal pain (85%), and flatulence (87%), compared with the standard care group (49%, 61%, and 50%, respectively).

More research is needed, but the data support the potential effectiveness of a low-FODMAP diet, Dr. Gibson said.

Some examples of foods to include as part of a low-FODMAP diet are bananas, blueberries, lettuce, potatoes, gluten-free bread or cereal products, rice, oats, hard cheeses, lactose-free milk, sugar, molasses, and most artificial sweeteners with names that do not end in "ol."*

Foods to eliminate when following a low-FODMAP diet include apples, pears, canned fruit in natural juice, high-fructose corn syrup, cows’ milk (which contains lactose), soft cheese, broccoli, cabbage, pasta, bread, or baked goods made from wheat or rye, mushrooms, and sweeteners ending in "ol," such as sorbitol.

A potential limitation of using the low-FODMAP diet is that it requires collaboration with a dietitian who is familiar with the diet, Dr. Gibson noted, and the diet is relatively unknown in the United States.

However, it may catch on, Dr. William D. Chey said in an interview at the meeting. Dr. Chey is a professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan in Ann Arbor; he is also one of the two editors in chief of the American Journal of Gastroenterology.

"I think doctors are hungry for non-medical interventions" for IBS patients, Dr. Chey said. Although the diet is restrictive, many IBS patients are already on such restricted diets that the low-FODMAP diet actually broadens their food choices, which may promote adherence, he added.

More details about the low-FODMAP diet, including a complete list of foods and a database of knowledgeable dietitians, are available at ibsgroup.org/ibs-diet.

Dr. Gibson said he had no relevant financial disclosures. Dr. Chey has served as a consultant for multiple companies including AstraZeneca, Johnson & Johnson, Salix, and Takeda.

Correction: An earlier version of this story incorrectly named a few items on list of foods that may be consumed on the low-FODMAP diet. The error has been corrected.

NATIONAL HARBOR, MD. – "Food is what patients blame for their gastrointestinal symptoms," Dr. Peter Gibson said at the annual meeting of the American College of Gastroenterology.

And patients with functional GI disorders may be on the right track, according to Dr. Gibson, professor of medicine at Monash University in Victoria, Australia. He presented a novel dietary treatment that is not well known in the United States but appears promising as a strategy for managing irritable bowel syndrome (IBS) and other functional GI problems.

(c) Christian Pedant/fotolia.com

Dr. Gibson also said that physicians who want to help their patients manage their symptoms need to understand how foods can interact with the enteric nervous system, which controls most GI functions.

More specifically, certain types of sugars found in many foods are rapidly absorbed and fermented, drawing liquid into the GI tract, which can cause distension and trigger the symptoms of IBS, such as bloating and pain, he said.

The novel dietary approach is known by the acronym FODMAP, which stands for the types of sugars suspected of causing symptoms: fermentable sugars, oligosaccharides, disaccharides, monosaccharides, and polyols (such as sorbitol or mannitol). Thus the regimen designed to reduce symptoms is called a low-FODMAP diet, said Dr. Gibson.

Data are limited, but in theory, a low-FODMAP diet causes less distension of the intestinal lumen and thereby reduces IBS symptoms. His colleague, Susan Shepherd, Ph.D., who is a dietitian, has developed a list of foods that should be included, and others to exclude, when following such a diet.

In a recent study, 82 IBS patients were randomized to receive either standard dietary advice (39 people) or instruction on following a low-FODMAP diet (43 people); the patients were meeting with a dietitian on an outpatient basis (J. Hum. Nutr. Diet 2011;24:487-95).

Composite IBS symptom scores showed that significantly more patients in the low-FODMAP group had overall improvement in their symptoms, compared with the standard care group (86% vs. 49%). In addition, significantly more low-FODMAP patients reported improvements in bloating (82%), abdominal pain (85%), and flatulence (87%), compared with the standard care group (49%, 61%, and 50%, respectively).

More research is needed, but the data support the potential effectiveness of a low-FODMAP diet, Dr. Gibson said.

Some examples of foods to include as part of a low-FODMAP diet are bananas, blueberries, lettuce, potatoes, gluten-free bread or cereal products, rice, oats, hard cheeses, lactose-free milk, sugar, molasses, and most artificial sweeteners with names that do not end in "ol."*

Foods to eliminate when following a low-FODMAP diet include apples, pears, canned fruit in natural juice, high-fructose corn syrup, cows’ milk (which contains lactose), soft cheese, broccoli, cabbage, pasta, bread, or baked goods made from wheat or rye, mushrooms, and sweeteners ending in "ol," such as sorbitol.

A potential limitation of using the low-FODMAP diet is that it requires collaboration with a dietitian who is familiar with the diet, Dr. Gibson noted, and the diet is relatively unknown in the United States.

However, it may catch on, Dr. William D. Chey said in an interview at the meeting. Dr. Chey is a professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan in Ann Arbor; he is also one of the two editors in chief of the American Journal of Gastroenterology.

"I think doctors are hungry for non-medical interventions" for IBS patients, Dr. Chey said. Although the diet is restrictive, many IBS patients are already on such restricted diets that the low-FODMAP diet actually broadens their food choices, which may promote adherence, he added.

More details about the low-FODMAP diet, including a complete list of foods and a database of knowledgeable dietitians, are available at ibsgroup.org/ibs-diet.

Dr. Gibson said he had no relevant financial disclosures. Dr. Chey has served as a consultant for multiple companies including AstraZeneca, Johnson & Johnson, Salix, and Takeda.

Correction: An earlier version of this story incorrectly named a few items on list of foods that may be consumed on the low-FODMAP diet. The error has been corrected.

NATIONAL HARBOR, MD. – "Food is what patients blame for their gastrointestinal symptoms," Dr. Peter Gibson said at the annual meeting of the American College of Gastroenterology.

And patients with functional GI disorders may be on the right track, according to Dr. Gibson, professor of medicine at Monash University in Victoria, Australia. He presented a novel dietary treatment that is not well known in the United States but appears promising as a strategy for managing irritable bowel syndrome (IBS) and other functional GI problems.

(c) Christian Pedant/fotolia.com

Dr. Gibson also said that physicians who want to help their patients manage their symptoms need to understand how foods can interact with the enteric nervous system, which controls most GI functions.

More specifically, certain types of sugars found in many foods are rapidly absorbed and fermented, drawing liquid into the GI tract, which can cause distension and trigger the symptoms of IBS, such as bloating and pain, he said.

The novel dietary approach is known by the acronym FODMAP, which stands for the types of sugars suspected of causing symptoms: fermentable sugars, oligosaccharides, disaccharides, monosaccharides, and polyols (such as sorbitol or mannitol). Thus the regimen designed to reduce symptoms is called a low-FODMAP diet, said Dr. Gibson.

Data are limited, but in theory, a low-FODMAP diet causes less distension of the intestinal lumen and thereby reduces IBS symptoms. His colleague, Susan Shepherd, Ph.D., who is a dietitian, has developed a list of foods that should be included, and others to exclude, when following such a diet.

In a recent study, 82 IBS patients were randomized to receive either standard dietary advice (39 people) or instruction on following a low-FODMAP diet (43 people); the patients were meeting with a dietitian on an outpatient basis (J. Hum. Nutr. Diet 2011;24:487-95).

Composite IBS symptom scores showed that significantly more patients in the low-FODMAP group had overall improvement in their symptoms, compared with the standard care group (86% vs. 49%). In addition, significantly more low-FODMAP patients reported improvements in bloating (82%), abdominal pain (85%), and flatulence (87%), compared with the standard care group (49%, 61%, and 50%, respectively).

More research is needed, but the data support the potential effectiveness of a low-FODMAP diet, Dr. Gibson said.

Some examples of foods to include as part of a low-FODMAP diet are bananas, blueberries, lettuce, potatoes, gluten-free bread or cereal products, rice, oats, hard cheeses, lactose-free milk, sugar, molasses, and most artificial sweeteners with names that do not end in "ol."*

Foods to eliminate when following a low-FODMAP diet include apples, pears, canned fruit in natural juice, high-fructose corn syrup, cows’ milk (which contains lactose), soft cheese, broccoli, cabbage, pasta, bread, or baked goods made from wheat or rye, mushrooms, and sweeteners ending in "ol," such as sorbitol.

A potential limitation of using the low-FODMAP diet is that it requires collaboration with a dietitian who is familiar with the diet, Dr. Gibson noted, and the diet is relatively unknown in the United States.

However, it may catch on, Dr. William D. Chey said in an interview at the meeting. Dr. Chey is a professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan in Ann Arbor; he is also one of the two editors in chief of the American Journal of Gastroenterology.

"I think doctors are hungry for non-medical interventions" for IBS patients, Dr. Chey said. Although the diet is restrictive, many IBS patients are already on such restricted diets that the low-FODMAP diet actually broadens their food choices, which may promote adherence, he added.

More details about the low-FODMAP diet, including a complete list of foods and a database of knowledgeable dietitians, are available at ibsgroup.org/ibs-diet.

Dr. Gibson said he had no relevant financial disclosures. Dr. Chey has served as a consultant for multiple companies including AstraZeneca, Johnson & Johnson, Salix, and Takeda.

Correction: An earlier version of this story incorrectly named a few items on list of foods that may be consumed on the low-FODMAP diet. The error has been corrected.

Despite the Food and Drug Administration’s finding that Plan B One-Step, an emergency contraceptive, is safe, effective, and should be approved for nonprescription use by all women of childbearing potential, the drug remains unavailable without a prescription for those under 17 years old.

Dr. Margaret Hamburg, FDA Commissioner, announced her agency’s analysis and finding Dec. 7, but noted that Health and Human Services Secretary Kathleen Sebelius had overruled the decision.

In a memo, Ms. Sebelius disagreed with the FDA’s decision to extend approval of Plan B One-Step for nonprescription use by all women of childbearing potential based on her stated concern that the studies submitted to the FDA do not include data on girls of all ages who would be granted nonprescription access to the drug.

"It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages," she said.

Plan B One-Step, a 1.5-mg levonorgestrel tablet, was first approved by the FDA in 2006 for use without a prescription by females aged 17 years and older, and by prescription only for girls younger than 17 years. The pill has been shown to reduce the chance of pregnancy after unprotected sex.

In February 2011, drug manufacturer Teva Pharmaceuticals appealed to the FDA to lift the prescription-only requirement for females younger than 17 years, triggering a review of the evidence by the FDA Center for Drug Evaluation and Research.

"Based on the information submitted to the agency, [the Center for Drug Evaluation and Research] determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases," Dr. Hamburg said in her statement. "Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a health care provider."

However, because of the HHS secretary’s objection, the FDA has issued a response letter to Teva stating that Plan B One-Step is not approved without a prescription for females younger than 17 years.

The product will remain on the market and available to females of all ages, with no prescription necessary for females aged 17 years and older.

Despite the Food and Drug Administration’s finding that Plan B One-Step, an emergency contraceptive, is safe, effective, and should be approved for nonprescription use by all women of childbearing potential, the drug remains unavailable without a prescription for those under 17 years old.

Dr. Margaret Hamburg, FDA Commissioner, announced her agency’s analysis and finding Dec. 7, but noted that Health and Human Services Secretary Kathleen Sebelius had overruled the decision.

In a memo, Ms. Sebelius disagreed with the FDA’s decision to extend approval of Plan B One-Step for nonprescription use by all women of childbearing potential based on her stated concern that the studies submitted to the FDA do not include data on girls of all ages who would be granted nonprescription access to the drug.

"It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages," she said.

Plan B One-Step, a 1.5-mg levonorgestrel tablet, was first approved by the FDA in 2006 for use without a prescription by females aged 17 years and older, and by prescription only for girls younger than 17 years. The pill has been shown to reduce the chance of pregnancy after unprotected sex.

In February 2011, drug manufacturer Teva Pharmaceuticals appealed to the FDA to lift the prescription-only requirement for females younger than 17 years, triggering a review of the evidence by the FDA Center for Drug Evaluation and Research.

"Based on the information submitted to the agency, [the Center for Drug Evaluation and Research] determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases," Dr. Hamburg said in her statement. "Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a health care provider."

However, because of the HHS secretary’s objection, the FDA has issued a response letter to Teva stating that Plan B One-Step is not approved without a prescription for females younger than 17 years.

The product will remain on the market and available to females of all ages, with no prescription necessary for females aged 17 years and older.

Despite the Food and Drug Administration’s finding that Plan B One-Step, an emergency contraceptive, is safe, effective, and should be approved for nonprescription use by all women of childbearing potential, the drug remains unavailable without a prescription for those under 17 years old.

Dr. Margaret Hamburg, FDA Commissioner, announced her agency’s analysis and finding Dec. 7, but noted that Health and Human Services Secretary Kathleen Sebelius had overruled the decision.

In a memo, Ms. Sebelius disagreed with the FDA’s decision to extend approval of Plan B One-Step for nonprescription use by all women of childbearing potential based on her stated concern that the studies submitted to the FDA do not include data on girls of all ages who would be granted nonprescription access to the drug.

"It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages," she said.

Plan B One-Step, a 1.5-mg levonorgestrel tablet, was first approved by the FDA in 2006 for use without a prescription by females aged 17 years and older, and by prescription only for girls younger than 17 years. The pill has been shown to reduce the chance of pregnancy after unprotected sex.

In February 2011, drug manufacturer Teva Pharmaceuticals appealed to the FDA to lift the prescription-only requirement for females younger than 17 years, triggering a review of the evidence by the FDA Center for Drug Evaluation and Research.

"Based on the information submitted to the agency, [the Center for Drug Evaluation and Research] determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases," Dr. Hamburg said in her statement. "Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a health care provider."

However, because of the HHS secretary’s objection, the FDA has issued a response letter to Teva stating that Plan B One-Step is not approved without a prescription for females younger than 17 years.

The product will remain on the market and available to females of all ages, with no prescription necessary for females aged 17 years and older.

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology.

"Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as Barrett’s esophagus less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validation of the study findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigation of the clinical significance of recurrence at the gastroesophageal junction, Dr. Tian said.

Dr. Tian had no financial conflicts to disclose. Several study coauthors disclosed financial relationships with companies including Olympus, Fujinon, and Barrx.

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology.

"Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as Barrett’s esophagus less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validation of the study findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigation of the clinical significance of recurrence at the gastroesophageal junction, Dr. Tian said.

Dr. Tian had no financial conflicts to disclose. Several study coauthors disclosed financial relationships with companies including Olympus, Fujinon, and Barrx.

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology.

"Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as Barrett’s esophagus less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validation of the study findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigation of the clinical significance of recurrence at the gastroesophageal junction, Dr. Tian said.

Dr. Tian had no financial conflicts to disclose. Several study coauthors disclosed financial relationships with companies including Olympus, Fujinon, and Barrx.

Epilepsy, like other chronic medical conditions, leaves affected individuals feeling out of control and isolated, says Shelly Stoll, MPH, of the University of Michigan.

Ms. Stoll, along with colleagues at the university and the Epilepsy Foundation of Michigan, developed a program for individuals with epilepsy (IWE) to improve their self-care.

Photo Credit: Lidingo

The researchers conducted a pilot study of their intervention and presented the results at the annual meeting of the American Epilepsy Society in Baltimore, Md.

The 21 study participants were epilepsy patients aged 21 years and older. They completed telephone interviews at baseline and four months after completing the 6-week intervention.

The FOCUS intervention includes five elements:

-Figure out the problem or issue.

-Observe your routine.

-Choose a change goal.

-Undertake a change strategy.

-Study the results and select a reward.

The intervention included a day-long workshop followed by weekly telephone calls with a coach, some of which were conference calls with other patients.

Although this intervention didn’t reduce the frequency of seizures, the patients showed significant improvement from baseline in terms of quality of life and positive well-being.

The researchers admitted that the study is small and the findings preliminary, but the results merit a larger study with a longer time frame. Ideally, patients who participated in this study will continue to benefit. The researchers quoted one satisfied patient, who said, “I plan to keep moving forward, empowering and taking my life into my hands regardless of how epilepsy has tried to conquer me.”

The study was supported by the Centers for Disease Control and Prevention and the Managing Epilepsy Well network.

(On Twitter @hsplete)

^{(Photo courtesy of Lidingo via wikimedia commons (creative commons attribution share-alike license)}

Epilepsy, like other chronic medical conditions, leaves affected individuals feeling out of control and isolated, says Shelly Stoll, MPH, of the University of Michigan.

Ms. Stoll, along with colleagues at the university and the Epilepsy Foundation of Michigan, developed a program for individuals with epilepsy (IWE) to improve their self-care.

Photo Credit: Lidingo

The researchers conducted a pilot study of their intervention and presented the results at the annual meeting of the American Epilepsy Society in Baltimore, Md.

The 21 study participants were epilepsy patients aged 21 years and older. They completed telephone interviews at baseline and four months after completing the 6-week intervention.

The FOCUS intervention includes five elements:

-Figure out the problem or issue.

-Observe your routine.

-Choose a change goal.

-Undertake a change strategy.

-Study the results and select a reward.

The intervention included a day-long workshop followed by weekly telephone calls with a coach, some of which were conference calls with other patients.

Although this intervention didn’t reduce the frequency of seizures, the patients showed significant improvement from baseline in terms of quality of life and positive well-being.

The researchers admitted that the study is small and the findings preliminary, but the results merit a larger study with a longer time frame. Ideally, patients who participated in this study will continue to benefit. The researchers quoted one satisfied patient, who said, “I plan to keep moving forward, empowering and taking my life into my hands regardless of how epilepsy has tried to conquer me.”

The study was supported by the Centers for Disease Control and Prevention and the Managing Epilepsy Well network.

(On Twitter @hsplete)

^{(Photo courtesy of Lidingo via wikimedia commons (creative commons attribution share-alike license)}

Epilepsy, like other chronic medical conditions, leaves affected individuals feeling out of control and isolated, says Shelly Stoll, MPH, of the University of Michigan.

Ms. Stoll, along with colleagues at the university and the Epilepsy Foundation of Michigan, developed a program for individuals with epilepsy (IWE) to improve their self-care.

Photo Credit: Lidingo

The researchers conducted a pilot study of their intervention and presented the results at the annual meeting of the American Epilepsy Society in Baltimore, Md.

The 21 study participants were epilepsy patients aged 21 years and older. They completed telephone interviews at baseline and four months after completing the 6-week intervention.

The FOCUS intervention includes five elements:

-Figure out the problem or issue.

-Observe your routine.

-Choose a change goal.

-Undertake a change strategy.

-Study the results and select a reward.

The intervention included a day-long workshop followed by weekly telephone calls with a coach, some of which were conference calls with other patients.

Although this intervention didn’t reduce the frequency of seizures, the patients showed significant improvement from baseline in terms of quality of life and positive well-being.

The researchers admitted that the study is small and the findings preliminary, but the results merit a larger study with a longer time frame. Ideally, patients who participated in this study will continue to benefit. The researchers quoted one satisfied patient, who said, “I plan to keep moving forward, empowering and taking my life into my hands regardless of how epilepsy has tried to conquer me.”

The study was supported by the Centers for Disease Control and Prevention and the Managing Epilepsy Well network.

(On Twitter @hsplete)

^{(Photo courtesy of Lidingo via wikimedia commons (creative commons attribution share-alike license)}

BALTIMORE – Gamma Knife surgery significantly reduced the number of seizures in a subset of patients with rare congenital tumors, based on data from a prospective trial of 64 patients presented at the annual meeting of the American Epilepsy Society.

Hypothalamic hamartomas (congenital tumors that are attached to functional brain tissue) can cause a range of complications, including intractable seizures, said Dr. Jean Régis of Timone University Hospital in Marseilles, France.

Dr. Régis’s center is one of the few in the world where Gamma Knife surgery is performed on patients with hypothalamic hamartomas (HH). His ongoing study includes patients as young as age 3 years who have undergone surgery for HH. After a median of 62 months’ follow-up, the number of seizures in this group dropped from a median of 92 per month to a median of 6 per month.

But the benefits of the surgery extended beyond seizure reduction, Dr. Régis emphasized. Global psychiatric and cognitive comorbidity was considered cured in 28% of patients, improved in 56% of patients, and stable in 8% of patients at postsurgical follow-up.

Hyperkinetic behavior was identified in 34 patients at baseline. After surgery, 35% of patients were cured of hyperkinetic behavior and 30% were very much improved, Dr. Régis said. In addition, heteroaggressive behavior was noted in 56 patients at baseline, but after surgery, the behavior completely disappeared in 53% of these patients and was dramatically reduced in 32%, he added.

The specific approach for Gamma Knife surgery depends on the anatomy of the lesion, Dr. Régis noted. Most of the patients in this study had hamartomas of types I-IV, which are the smaller lesions, he said. The median marginal dose of radiation was 17 Gy and the median volume was 419 mm³.

"Longer follow-up remains mandatory due to the young age of this population," Dr. Régis said.

"Beyond seizure reduction, the improvement of the psychiatric, cognitive condition, and school and social insertion is turning out to be the major benefit of GKS in this frequently catastrophic epilepsy group," he added.

Dr. Régis is the president of the International Stereotactic Radiosurgery Society (ISRS) and chairman of its 2011 congress. He said he has raised major congress funding from the following manufacturers of radiosurgery devices: Accuray, BrainLab, Elekta, and Radionic.

BALTIMORE – Gamma Knife surgery significantly reduced the number of seizures in a subset of patients with rare congenital tumors, based on data from a prospective trial of 64 patients presented at the annual meeting of the American Epilepsy Society.

Hypothalamic hamartomas (congenital tumors that are attached to functional brain tissue) can cause a range of complications, including intractable seizures, said Dr. Jean Régis of Timone University Hospital in Marseilles, France.

Dr. Régis’s center is one of the few in the world where Gamma Knife surgery is performed on patients with hypothalamic hamartomas (HH). His ongoing study includes patients as young as age 3 years who have undergone surgery for HH. After a median of 62 months’ follow-up, the number of seizures in this group dropped from a median of 92 per month to a median of 6 per month.

But the benefits of the surgery extended beyond seizure reduction, Dr. Régis emphasized. Global psychiatric and cognitive comorbidity was considered cured in 28% of patients, improved in 56% of patients, and stable in 8% of patients at postsurgical follow-up.

Hyperkinetic behavior was identified in 34 patients at baseline. After surgery, 35% of patients were cured of hyperkinetic behavior and 30% were very much improved, Dr. Régis said. In addition, heteroaggressive behavior was noted in 56 patients at baseline, but after surgery, the behavior completely disappeared in 53% of these patients and was dramatically reduced in 32%, he added.

The specific approach for Gamma Knife surgery depends on the anatomy of the lesion, Dr. Régis noted. Most of the patients in this study had hamartomas of types I-IV, which are the smaller lesions, he said. The median marginal dose of radiation was 17 Gy and the median volume was 419 mm³.

"Longer follow-up remains mandatory due to the young age of this population," Dr. Régis said.

"Beyond seizure reduction, the improvement of the psychiatric, cognitive condition, and school and social insertion is turning out to be the major benefit of GKS in this frequently catastrophic epilepsy group," he added.

Dr. Régis is the president of the International Stereotactic Radiosurgery Society (ISRS) and chairman of its 2011 congress. He said he has raised major congress funding from the following manufacturers of radiosurgery devices: Accuray, BrainLab, Elekta, and Radionic.

BALTIMORE – Gamma Knife surgery significantly reduced the number of seizures in a subset of patients with rare congenital tumors, based on data from a prospective trial of 64 patients presented at the annual meeting of the American Epilepsy Society.

Hypothalamic hamartomas (congenital tumors that are attached to functional brain tissue) can cause a range of complications, including intractable seizures, said Dr. Jean Régis of Timone University Hospital in Marseilles, France.

Dr. Régis’s center is one of the few in the world where Gamma Knife surgery is performed on patients with hypothalamic hamartomas (HH). His ongoing study includes patients as young as age 3 years who have undergone surgery for HH. After a median of 62 months’ follow-up, the number of seizures in this group dropped from a median of 92 per month to a median of 6 per month.

But the benefits of the surgery extended beyond seizure reduction, Dr. Régis emphasized. Global psychiatric and cognitive comorbidity was considered cured in 28% of patients, improved in 56% of patients, and stable in 8% of patients at postsurgical follow-up.

Hyperkinetic behavior was identified in 34 patients at baseline. After surgery, 35% of patients were cured of hyperkinetic behavior and 30% were very much improved, Dr. Régis said. In addition, heteroaggressive behavior was noted in 56 patients at baseline, but after surgery, the behavior completely disappeared in 53% of these patients and was dramatically reduced in 32%, he added.

The specific approach for Gamma Knife surgery depends on the anatomy of the lesion, Dr. Régis noted. Most of the patients in this study had hamartomas of types I-IV, which are the smaller lesions, he said. The median marginal dose of radiation was 17 Gy and the median volume was 419 mm³.

"Longer follow-up remains mandatory due to the young age of this population," Dr. Régis said.

"Beyond seizure reduction, the improvement of the psychiatric, cognitive condition, and school and social insertion is turning out to be the major benefit of GKS in this frequently catastrophic epilepsy group," he added.

Dr. Régis is the president of the International Stereotactic Radiosurgery Society (ISRS) and chairman of its 2011 congress. He said he has raised major congress funding from the following manufacturers of radiosurgery devices: Accuray, BrainLab, Elekta, and Radionic.

NATIONAL HARBOR, MD. – Prophylactic use of probiotics appeared to reduce the odds of developing antibiotic-associated diarrhea by 60%, based on data from a meta-analysis of more than 3,000 patients. The findings were presented at the annual meeting of the American College of Gastroenterology.

The incidence and severity of antibiotic-associated diarrhea (AAD) are increasing in the United States, with major financial and clinical implications, said Dr. Steven Shamah, a resident in Internal Medicine at Maimonides Medical Center in Brooklyn, N.Y.

"Given the enormous cost, morbidity, and mortality associated with this [disorder], it is important to identify those at-risk populations and institute preventative measures," Dr. Shamah said. The most common type of AAD is Clostridium difficile–associated diarrhea (CDAD), he said.

Several studies have examined the effectiveness of daily treatment with probiotics to prevent antibiotic-associated diarrhea, but results have been mixed, he noted. Dr. Shamah and colleagues reviewed data from 22 studies including 3,096 patients, 63% of which were adults. A total of 53% of the study subjects were from outpatient settings and 47% were hospitalized patients.

The researchers conducted a chi square analysis of patients who had successful and failed probiotic treatments. Overall, patients who took probiotics had significantly reduced odds of developing AAD (odds ratio, 0.39). The probiotic treatment periods ranged from 5 days to 3 weeks, with an average treatment duration of 1.5 weeks, Dr. Shamah said.

"This analysis clearly demonstrates that probiotics offer protective benefit in the prevention of [AAD]," said Dr. Shamah. All patients who are at high risk for AAD should receive probiotic prophylaxis, he added. Risk factors for AAD include recent antibiotics use, old age, recent hospitalization, low albumin, and immunosuppression.

However, additional prospective studies are needed to determine the most effective dose, duration, and specific species of probiotics to prevent AAD and CDAD in these patients, he noted.

Dr. Shamah said he had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Prophylactic use of probiotics appeared to reduce the odds of developing antibiotic-associated diarrhea by 60%, based on data from a meta-analysis of more than 3,000 patients. The findings were presented at the annual meeting of the American College of Gastroenterology.

The incidence and severity of antibiotic-associated diarrhea (AAD) are increasing in the United States, with major financial and clinical implications, said Dr. Steven Shamah, a resident in Internal Medicine at Maimonides Medical Center in Brooklyn, N.Y.

"Given the enormous cost, morbidity, and mortality associated with this [disorder], it is important to identify those at-risk populations and institute preventative measures," Dr. Shamah said. The most common type of AAD is Clostridium difficile–associated diarrhea (CDAD), he said.

Several studies have examined the effectiveness of daily treatment with probiotics to prevent antibiotic-associated diarrhea, but results have been mixed, he noted. Dr. Shamah and colleagues reviewed data from 22 studies including 3,096 patients, 63% of which were adults. A total of 53% of the study subjects were from outpatient settings and 47% were hospitalized patients.

The researchers conducted a chi square analysis of patients who had successful and failed probiotic treatments. Overall, patients who took probiotics had significantly reduced odds of developing AAD (odds ratio, 0.39). The probiotic treatment periods ranged from 5 days to 3 weeks, with an average treatment duration of 1.5 weeks, Dr. Shamah said.

"This analysis clearly demonstrates that probiotics offer protective benefit in the prevention of [AAD]," said Dr. Shamah. All patients who are at high risk for AAD should receive probiotic prophylaxis, he added. Risk factors for AAD include recent antibiotics use, old age, recent hospitalization, low albumin, and immunosuppression.

However, additional prospective studies are needed to determine the most effective dose, duration, and specific species of probiotics to prevent AAD and CDAD in these patients, he noted.

Dr. Shamah said he had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Prophylactic use of probiotics appeared to reduce the odds of developing antibiotic-associated diarrhea by 60%, based on data from a meta-analysis of more than 3,000 patients. The findings were presented at the annual meeting of the American College of Gastroenterology.

The incidence and severity of antibiotic-associated diarrhea (AAD) are increasing in the United States, with major financial and clinical implications, said Dr. Steven Shamah, a resident in Internal Medicine at Maimonides Medical Center in Brooklyn, N.Y.

"Given the enormous cost, morbidity, and mortality associated with this [disorder], it is important to identify those at-risk populations and institute preventative measures," Dr. Shamah said. The most common type of AAD is Clostridium difficile–associated diarrhea (CDAD), he said.

Several studies have examined the effectiveness of daily treatment with probiotics to prevent antibiotic-associated diarrhea, but results have been mixed, he noted. Dr. Shamah and colleagues reviewed data from 22 studies including 3,096 patients, 63% of which were adults. A total of 53% of the study subjects were from outpatient settings and 47% were hospitalized patients.

The researchers conducted a chi square analysis of patients who had successful and failed probiotic treatments. Overall, patients who took probiotics had significantly reduced odds of developing AAD (odds ratio, 0.39). The probiotic treatment periods ranged from 5 days to 3 weeks, with an average treatment duration of 1.5 weeks, Dr. Shamah said.

"This analysis clearly demonstrates that probiotics offer protective benefit in the prevention of [AAD]," said Dr. Shamah. All patients who are at high risk for AAD should receive probiotic prophylaxis, he added. Risk factors for AAD include recent antibiotics use, old age, recent hospitalization, low albumin, and immunosuppression.

However, additional prospective studies are needed to determine the most effective dose, duration, and specific species of probiotics to prevent AAD and CDAD in these patients, he noted.

Dr. Shamah said he had no financial conflicts to disclose.

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.

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.

Previous studies have shown thathcardiovascular 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.

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, 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.

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.

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.

Previous studies have shown thathcardiovascular 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.

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, 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.

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.

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.

Previous studies have shown thathcardiovascular 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.

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, 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.

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.

Major Finding: The risk for the developing metabolic syndrome in children and adolescents increases sharply between 3 and 12 months of antipsychotic treatment.

Data Source: A longitudinal study of 235 children and adolescents with schizophrenia or other disorders or psychotic symptoms, bipolar disorders, and other disorders.

Disclosures: The study was funded by the Spanish Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.

PARIS – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the meeting.

Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well-studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.

At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.

The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients).

The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.

The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively.

Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.

The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively.

The researchers defined “at risk” as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.

The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.

Major Finding: The risk for the developing metabolic syndrome in children and adolescents increases sharply between 3 and 12 months of antipsychotic treatment.

Data Source: A longitudinal study of 235 children and adolescents with schizophrenia or other disorders or psychotic symptoms, bipolar disorders, and other disorders.

Disclosures: The study was funded by the Spanish Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.

PARIS – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the meeting.

Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well-studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.

At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.

The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients).

The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.

The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively.

Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.

The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively.

The researchers defined “at risk” as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.

The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.

Major Finding: The risk for the developing metabolic syndrome in children and adolescents increases sharply between 3 and 12 months of antipsychotic treatment.

Data Source: A longitudinal study of 235 children and adolescents with schizophrenia or other disorders or psychotic symptoms, bipolar disorders, and other disorders.

Disclosures: The study was funded by the Spanish Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.

PARIS – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the meeting.

Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well-studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.

At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.

The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients).

The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.

The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively.

Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.

The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively.

The researchers defined “at risk” as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.

The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.