Robert Finn

Use of metformin to treat patients with type 2 diabetes shows no association with bone fractures.

Long-term insulin use also showed no association with fractures, whereas current treatment with insulin was associated with an increase in the risk of fractures in men but not in women, reported Dr. Matteo Monami of the University of Florence (Italy), and colleagues. They conducted a case-control study in a cohort of 1,945 diabetic outpatients. They compared 83 patients who had bone fractures with a control group of 249 patients matched for age, sex, duration of diabetes, body mass index, hemoglobin A_1c, comorbidity, smoking, and alcohol abuse. The average patient age was 69 years, 64% of patients in each group were female, and in both groups, patients had had diabetes for a mean 12.5 years.

In those with fractures, 29% had been exposed to secretagogues for at least 36 months in the previous 10 years, compared with 41% of controls, a significant difference. After adjusting for concomitant hypo-glycemic medications, there was no significant link between bone fractures and long-term use of any of the medications, including secretagogues, metformin, and insulin.

However, fractures were significantly more likely in men who were undergoing insulin treatment than in those who were not, with an adjusted odds ratio of 3.2. There was no similar significant association in women (Diabetes Care 2008;31:199–203).

“The results are consistent with the hypothesis that insulin could increase [fracture] risk through falls due to hypoglycemic episodes without negative effects on bone metabolism,” said the authors, who made no disclosures about conflicts of interest.

Use of metformin to treat patients with type 2 diabetes shows no association with bone fractures.

Long-term insulin use also showed no association with fractures, whereas current treatment with insulin was associated with an increase in the risk of fractures in men but not in women, reported Dr. Matteo Monami of the University of Florence (Italy), and colleagues. They conducted a case-control study in a cohort of 1,945 diabetic outpatients. They compared 83 patients who had bone fractures with a control group of 249 patients matched for age, sex, duration of diabetes, body mass index, hemoglobin A_1c, comorbidity, smoking, and alcohol abuse. The average patient age was 69 years, 64% of patients in each group were female, and in both groups, patients had had diabetes for a mean 12.5 years.

In those with fractures, 29% had been exposed to secretagogues for at least 36 months in the previous 10 years, compared with 41% of controls, a significant difference. After adjusting for concomitant hypo-glycemic medications, there was no significant link between bone fractures and long-term use of any of the medications, including secretagogues, metformin, and insulin.

However, fractures were significantly more likely in men who were undergoing insulin treatment than in those who were not, with an adjusted odds ratio of 3.2. There was no similar significant association in women (Diabetes Care 2008;31:199–203).

“The results are consistent with the hypothesis that insulin could increase [fracture] risk through falls due to hypoglycemic episodes without negative effects on bone metabolism,” said the authors, who made no disclosures about conflicts of interest.

Use of metformin to treat patients with type 2 diabetes shows no association with bone fractures.

Long-term insulin use also showed no association with fractures, whereas current treatment with insulin was associated with an increase in the risk of fractures in men but not in women, reported Dr. Matteo Monami of the University of Florence (Italy), and colleagues. They conducted a case-control study in a cohort of 1,945 diabetic outpatients. They compared 83 patients who had bone fractures with a control group of 249 patients matched for age, sex, duration of diabetes, body mass index, hemoglobin A_1c, comorbidity, smoking, and alcohol abuse. The average patient age was 69 years, 64% of patients in each group were female, and in both groups, patients had had diabetes for a mean 12.5 years.

In those with fractures, 29% had been exposed to secretagogues for at least 36 months in the previous 10 years, compared with 41% of controls, a significant difference. After adjusting for concomitant hypo-glycemic medications, there was no significant link between bone fractures and long-term use of any of the medications, including secretagogues, metformin, and insulin.

However, fractures were significantly more likely in men who were undergoing insulin treatment than in those who were not, with an adjusted odds ratio of 3.2. There was no similar significant association in women (Diabetes Care 2008;31:199–203).

“The results are consistent with the hypothesis that insulin could increase [fracture] risk through falls due to hypoglycemic episodes without negative effects on bone metabolism,” said the authors, who made no disclosures about conflicts of interest.

A meta-analysis has failed to clarify whether one drug is better than another when added to metformin in patients with type 2 diabetes.

Sulfonylureas and α-glucosidase inhibitors, and possibly glinides, seem to have about equal efficacy when used as add-ons to failed metformin monotherapy, Dr. Matteo Monami and colleagues from the University of Florence (Italy) found in an analysis of 27 clinical trials (Diabetes Res. Clin. Pract. 2008;79:196–203).

Thiazolidinediones seem to have a lesser effect on hemoglobin A_1c (HbA_1c) at 6 months, though in the long term, they may work better than insulin secretagogues.

The authors conducted their Medline search in January 2007, looking for randomized clinical trials in which metformin was associated with any one of a large number of add-on therapies. They included only trials in which a hypoglycemic agent was compared with either placebo or with another active drug in combination with metformin for at least 16 weeks.

They identified 16 placebo-controlled trials and 11 trials in which two active treatments were compared. Of the placebo-controlled trials, five included sulfonylureas, five included α-glucosidase inhibitors, three included thiazolidinediones, two included glinides, and one included GLP-1 agonists. Combining trials for each class of drugs, sulfonylureas reduced HbA_1c by an average of 0.85%, thiazolidinediones by 0.42%, and α-glucosidase inhibitors by 0.61%. After correcting for baseline HbA_1c, the reduction obtained with sulfonylurea with respect to placebo was significantly greater than that of thiazolidinediones. There were no significant differences between sulfonylurea and α-glucosidase inhibitors or between α-glucosidase inhibitors and thiazolidinediones.

Among the trials in which two active agents were compared, sulfonylureas were significantly superior to thiazolidinediones, with an overall difference between the two treatments of 0.17% in reducing HbA_1c. There were no significant differences between sulfonylureas and insulin. Insulin regimens that were based on two administrations of biphasic insulin analogues were more effective than insulin glargine once a day, with an overall difference of 0.26% in reducing HbA_1c.

The researchers had received speaking fees, consultancy fees, and research grants from several pharmaceutical firms.

A meta-analysis has failed to clarify whether one drug is better than another when added to metformin in patients with type 2 diabetes.

Sulfonylureas and α-glucosidase inhibitors, and possibly glinides, seem to have about equal efficacy when used as add-ons to failed metformin monotherapy, Dr. Matteo Monami and colleagues from the University of Florence (Italy) found in an analysis of 27 clinical trials (Diabetes Res. Clin. Pract. 2008;79:196–203).

Thiazolidinediones seem to have a lesser effect on hemoglobin A_1c (HbA_1c) at 6 months, though in the long term, they may work better than insulin secretagogues.

The authors conducted their Medline search in January 2007, looking for randomized clinical trials in which metformin was associated with any one of a large number of add-on therapies. They included only trials in which a hypoglycemic agent was compared with either placebo or with another active drug in combination with metformin for at least 16 weeks.

They identified 16 placebo-controlled trials and 11 trials in which two active treatments were compared. Of the placebo-controlled trials, five included sulfonylureas, five included α-glucosidase inhibitors, three included thiazolidinediones, two included glinides, and one included GLP-1 agonists. Combining trials for each class of drugs, sulfonylureas reduced HbA_1c by an average of 0.85%, thiazolidinediones by 0.42%, and α-glucosidase inhibitors by 0.61%. After correcting for baseline HbA_1c, the reduction obtained with sulfonylurea with respect to placebo was significantly greater than that of thiazolidinediones. There were no significant differences between sulfonylurea and α-glucosidase inhibitors or between α-glucosidase inhibitors and thiazolidinediones.

Among the trials in which two active agents were compared, sulfonylureas were significantly superior to thiazolidinediones, with an overall difference between the two treatments of 0.17% in reducing HbA_1c. There were no significant differences between sulfonylureas and insulin. Insulin regimens that were based on two administrations of biphasic insulin analogues were more effective than insulin glargine once a day, with an overall difference of 0.26% in reducing HbA_1c.

The researchers had received speaking fees, consultancy fees, and research grants from several pharmaceutical firms.

A meta-analysis has failed to clarify whether one drug is better than another when added to metformin in patients with type 2 diabetes.

Sulfonylureas and α-glucosidase inhibitors, and possibly glinides, seem to have about equal efficacy when used as add-ons to failed metformin monotherapy, Dr. Matteo Monami and colleagues from the University of Florence (Italy) found in an analysis of 27 clinical trials (Diabetes Res. Clin. Pract. 2008;79:196–203).

Thiazolidinediones seem to have a lesser effect on hemoglobin A_1c (HbA_1c) at 6 months, though in the long term, they may work better than insulin secretagogues.

The authors conducted their Medline search in January 2007, looking for randomized clinical trials in which metformin was associated with any one of a large number of add-on therapies. They included only trials in which a hypoglycemic agent was compared with either placebo or with another active drug in combination with metformin for at least 16 weeks.

They identified 16 placebo-controlled trials and 11 trials in which two active treatments were compared. Of the placebo-controlled trials, five included sulfonylureas, five included α-glucosidase inhibitors, three included thiazolidinediones, two included glinides, and one included GLP-1 agonists. Combining trials for each class of drugs, sulfonylureas reduced HbA_1c by an average of 0.85%, thiazolidinediones by 0.42%, and α-glucosidase inhibitors by 0.61%. After correcting for baseline HbA_1c, the reduction obtained with sulfonylurea with respect to placebo was significantly greater than that of thiazolidinediones. There were no significant differences between sulfonylurea and α-glucosidase inhibitors or between α-glucosidase inhibitors and thiazolidinediones.

Among the trials in which two active agents were compared, sulfonylureas were significantly superior to thiazolidinediones, with an overall difference between the two treatments of 0.17% in reducing HbA_1c. There were no significant differences between sulfonylureas and insulin. Insulin regimens that were based on two administrations of biphasic insulin analogues were more effective than insulin glargine once a day, with an overall difference of 0.26% in reducing HbA_1c.

The researchers had received speaking fees, consultancy fees, and research grants from several pharmaceutical firms.

Infants whose airways are colonized by one or more of three bacterial species are significantly more likely to develop asthma by 5 years of age than are other children.

Dr. Hans Bisgaard and his colleagues from the Copenhagen University Hospital found colonization with Streptococcus pneumoniae, Haemophilus influenzae, and/or Moraxella catarrhalis in 1-month-old infants also was associated with significant increases in the risk of the later development of certain asthma precursors, including persistent wheeze (hazard ratio 2.01), acute severe exacerbation of wheeze (HR 3.14), and hospitalization for wheeze (HR 3.57). Colonization by Staphylococcus aureus at 1 month of age, on the other hand, was not associated with an increased risk of asthma or its precursors, nor was colonization with any of the organisms at 12 months of age (N. Engl. J. Med. 2007;357:1487–95).

It's unlikely that this association is causal, Dr. Erika von Mutius wrote in an accompanying editorial (N. Engl. J. Med. 2007;357:1545). Instead, early colonization with those three organisms may signal a defective innate immune response, and it is that defective immune response that promotes the development of asthma.

The investigators followed 321 infants as part of the Copenhagen Prospective Study on Asthma in Childhood (COPSAC). All infants were born to mothers with current or previous asthma. Physicians aspirated samples from the asymptomatic infants' hypopharyngeal region at 1 and 12 months of age, and these samples were cultured for the presence of the four bacterial species. At 1 month, 21% of the infants were found to be colonized with S. pneumoniae, H. influenzae, and/or M. catarrhalis, and 61% were colonized with S. aureus. At 12 months, 71% were colonized with the first three organisms and only 13% were colonized with S. aureus.

Children colonized at 1 month of age who were available for testing at 5 years had a 33% (17 of 52) prevalence of asthma at that age, compared with 10% (20 of 208) in those not colonized. Total IgE was increased by 47% in colonized children; there was no significant increase in specific IgE.

Investigators adjusted the results for a number of possible confounders.

While Dr. Bisgaard and his colleagues proposed that bacterial colonization may induce neutrophilic inflammation of the airways and thereby cause asthma, Dr. von Mutius, professor of pediatrics at Munich University Children's Hospital and head of the outpatient clinic for asthma and allergy, disagreed. Colonization may indicate a defective clearance of those flora. The impaired innate immune response also might be expected to decrease a child's resistance to viruses, and studies have recognized that people with asthma are unable to limit viral infections to the upper respiratory tract.

It's possible, Dr. von Mutius wrote, that exposure to certain bacterial strains may contribute to the development of asthma by inducing inflammatory responses in a child's airway. But, if that were the case, treatment with antibiotics during the first weeks of life should protect children from developing asthma. While no clinical trial has examined this question, several population-based cohort studies have failed to find an association between early antibiotic therapies and the risk of asthma.

The study was supported by unrestricted educational grants from Pharmacia/Pfizer Inc. and AstraZeneca. Dr. Bisgaard has received lecture and advisory board fees from Aerocrine Inc., Altana Inc., AstraZeneca, GlaxoSmithKline, MedImmune Inc., Merck & Co., and Pfizer.

ELSEVIER GLOBAL MEDICAL NEWS

Infants whose airways are colonized by one or more of three bacterial species are significantly more likely to develop asthma by 5 years of age than are other children.

Dr. Hans Bisgaard and his colleagues from the Copenhagen University Hospital found colonization with Streptococcus pneumoniae, Haemophilus influenzae, and/or Moraxella catarrhalis in 1-month-old infants also was associated with significant increases in the risk of the later development of certain asthma precursors, including persistent wheeze (hazard ratio 2.01), acute severe exacerbation of wheeze (HR 3.14), and hospitalization for wheeze (HR 3.57). Colonization by Staphylococcus aureus at 1 month of age, on the other hand, was not associated with an increased risk of asthma or its precursors, nor was colonization with any of the organisms at 12 months of age (N. Engl. J. Med. 2007;357:1487–95).

It's unlikely that this association is causal, Dr. Erika von Mutius wrote in an accompanying editorial (N. Engl. J. Med. 2007;357:1545). Instead, early colonization with those three organisms may signal a defective innate immune response, and it is that defective immune response that promotes the development of asthma.

The investigators followed 321 infants as part of the Copenhagen Prospective Study on Asthma in Childhood (COPSAC). All infants were born to mothers with current or previous asthma. Physicians aspirated samples from the asymptomatic infants' hypopharyngeal region at 1 and 12 months of age, and these samples were cultured for the presence of the four bacterial species. At 1 month, 21% of the infants were found to be colonized with S. pneumoniae, H. influenzae, and/or M. catarrhalis, and 61% were colonized with S. aureus. At 12 months, 71% were colonized with the first three organisms and only 13% were colonized with S. aureus.

Children colonized at 1 month of age who were available for testing at 5 years had a 33% (17 of 52) prevalence of asthma at that age, compared with 10% (20 of 208) in those not colonized. Total IgE was increased by 47% in colonized children; there was no significant increase in specific IgE.

Investigators adjusted the results for a number of possible confounders.

While Dr. Bisgaard and his colleagues proposed that bacterial colonization may induce neutrophilic inflammation of the airways and thereby cause asthma, Dr. von Mutius, professor of pediatrics at Munich University Children's Hospital and head of the outpatient clinic for asthma and allergy, disagreed. Colonization may indicate a defective clearance of those flora. The impaired innate immune response also might be expected to decrease a child's resistance to viruses, and studies have recognized that people with asthma are unable to limit viral infections to the upper respiratory tract.

It's possible, Dr. von Mutius wrote, that exposure to certain bacterial strains may contribute to the development of asthma by inducing inflammatory responses in a child's airway. But, if that were the case, treatment with antibiotics during the first weeks of life should protect children from developing asthma. While no clinical trial has examined this question, several population-based cohort studies have failed to find an association between early antibiotic therapies and the risk of asthma.

The study was supported by unrestricted educational grants from Pharmacia/Pfizer Inc. and AstraZeneca. Dr. Bisgaard has received lecture and advisory board fees from Aerocrine Inc., Altana Inc., AstraZeneca, GlaxoSmithKline, MedImmune Inc., Merck & Co., and Pfizer.

ELSEVIER GLOBAL MEDICAL NEWS

Infants whose airways are colonized by one or more of three bacterial species are significantly more likely to develop asthma by 5 years of age than are other children.

Dr. Hans Bisgaard and his colleagues from the Copenhagen University Hospital found colonization with Streptococcus pneumoniae, Haemophilus influenzae, and/or Moraxella catarrhalis in 1-month-old infants also was associated with significant increases in the risk of the later development of certain asthma precursors, including persistent wheeze (hazard ratio 2.01), acute severe exacerbation of wheeze (HR 3.14), and hospitalization for wheeze (HR 3.57). Colonization by Staphylococcus aureus at 1 month of age, on the other hand, was not associated with an increased risk of asthma or its precursors, nor was colonization with any of the organisms at 12 months of age (N. Engl. J. Med. 2007;357:1487–95).

It's unlikely that this association is causal, Dr. Erika von Mutius wrote in an accompanying editorial (N. Engl. J. Med. 2007;357:1545). Instead, early colonization with those three organisms may signal a defective innate immune response, and it is that defective immune response that promotes the development of asthma.

The investigators followed 321 infants as part of the Copenhagen Prospective Study on Asthma in Childhood (COPSAC). All infants were born to mothers with current or previous asthma. Physicians aspirated samples from the asymptomatic infants' hypopharyngeal region at 1 and 12 months of age, and these samples were cultured for the presence of the four bacterial species. At 1 month, 21% of the infants were found to be colonized with S. pneumoniae, H. influenzae, and/or M. catarrhalis, and 61% were colonized with S. aureus. At 12 months, 71% were colonized with the first three organisms and only 13% were colonized with S. aureus.

Children colonized at 1 month of age who were available for testing at 5 years had a 33% (17 of 52) prevalence of asthma at that age, compared with 10% (20 of 208) in those not colonized. Total IgE was increased by 47% in colonized children; there was no significant increase in specific IgE.

Investigators adjusted the results for a number of possible confounders.

While Dr. Bisgaard and his colleagues proposed that bacterial colonization may induce neutrophilic inflammation of the airways and thereby cause asthma, Dr. von Mutius, professor of pediatrics at Munich University Children's Hospital and head of the outpatient clinic for asthma and allergy, disagreed. Colonization may indicate a defective clearance of those flora. The impaired innate immune response also might be expected to decrease a child's resistance to viruses, and studies have recognized that people with asthma are unable to limit viral infections to the upper respiratory tract.

It's possible, Dr. von Mutius wrote, that exposure to certain bacterial strains may contribute to the development of asthma by inducing inflammatory responses in a child's airway. But, if that were the case, treatment with antibiotics during the first weeks of life should protect children from developing asthma. While no clinical trial has examined this question, several population-based cohort studies have failed to find an association between early antibiotic therapies and the risk of asthma.

The study was supported by unrestricted educational grants from Pharmacia/Pfizer Inc. and AstraZeneca. Dr. Bisgaard has received lecture and advisory board fees from Aerocrine Inc., Altana Inc., AstraZeneca, GlaxoSmithKline, MedImmune Inc., Merck & Co., and Pfizer.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — Satavaptan and conivaptan seem effective in treating dilutional hyponatremia, a frequent consequence of heart failure and of renal failure.

Data supporting the efficacy of the vasopressin receptor antagonists for this indication were presented in two posters at the annual meeting of the American Society of Nephrology. Satavaptan has not yet received Food and Drug Administration approval. Conivaptan, which was approved in 2005 for euvolemic hyponatremia, received approval in early 2007 for dilutional (hypervolemic) hyponatremia.

The conivaptan study was supported by Astellas Pharma US Inc. and the satavaptan study was supported by Sanofi Aventis. Both companies manufacture the vasopressin receptor antagonists.

Safety and efficacy in patients with heart failure (HF) are noteworthy findings because the current labeling for conivaptan says the drug is not indicated for the treatment of HF and should be used in these patients only when the expected benefit of increased serum sodium outweighs the potential adverse events.

Dr. Stephen R. Goldsmith of the University of Minnesota, Minneapolis, and his colleagues reported that conivaptan was effective at dosages of 20–40 mg/day, yielding significant increases in serum sodium concentration and in the area under the serum sodium concentration curve, compared with placebo.

The study was a retrospective analysis of two trials of conivaptan, one a randomized controlled trial and the other an open-label trial of patients with euvolemic and hypervolemic (dilutional) hyponatremia. For their presentations, they limited analysis to the 28 patients in the randomized controlled trial and the 69 patients in the open-label trial with hypervolemic hyponatremia.

The patients had serum sodium concentrations of 115–130 mEq/L and fasting blood glucose levels of less than 275 mg/dL. Their mean age was 71 years, and 62% had heart failure. They received either a 20-mg IV loading dose of conivaptan or placebo by 30-minute IV infusion followed by a continuous 4-day IV infusion.

Conivaptan infusion was associated with increases in serum sodium concentration over baseline of 4 mEq/L or more at all dosages. This increase occurred in a median of 58 hours at the lowest dosage (20 mg/day) and in a median of 24 hours at the higher dosages (40 and 80 mg/day). Most of the patients treated with conivaptan achieved at least a 6-mEq/L increase in serum sodium concentration over baseline or normal serum sodium concentrations at or above 135 mEq/L.

Significantly more serious adverse events occurred in those treated with conivaptan, compared with those on placebo. Deaths occurred at a similar frequency across all four groups. The most common adverse events were infusion-site phlebitis, infusion-site reactions, vomiting, and hypotension.

Conivaptan was as effective and as safe in patients with HF as it was in patients with other conditions. Still, the drug is intended to treat the hyponatremia that accompanies HF and not HF itself, Dr. Goldsmith emphasized in an interview. But, “since there is inevitable decongestion with a vaptan as a consequence of the free water excretion, one does, of course, 'treat' the [heart failure] to some extent.”

In the other presentation, Dr. Doron Aronson of Rambam Medical Center, Haifa, Israel, and colleagues found 50 mg/day of satavaptan was superior to placebo with respect to the sodium responder rate.

That study involved 118 patients randomized to receive either placebo or satavaptan at 25 mg/day or 50 mg/day. All of the patients had dilutional hyponatremia with serum sodium concentrations between 115 and 132 mEq/L. Heart failure was the cause of hyponatremia in 76% of the patients. The study excluded those with liver cirrhosis or the syndrome of inappropriate antidiuretic hormone secretion.

At the end of the 4-day double-blind period, 61% of the patients in the 50-mg group had a sodium response, compared with 27% in the placebo group, a significant difference. The sodium responder rate seemed higher in the 25-mg group than in the placebo group, but this figure did not quite reach statistical significance.

The median time to response was 3.3 days in the 25-mg group and 2.8 days in the 500-mg group, both significantly shorter than that for placebo, where the median time to response was more than 4 days.

Significantly more patients in the satavaptan groups than in the placebo group had overly rapid correction of serum sodium (increases of 12 mEq/L or more within 24 hours). Other adverse events in the satavaptan groups were atrial fibrillation, a prolonged QTc interval, hypotension, hypertension, and pyrexia.

SAN FRANCISCO — Satavaptan and conivaptan seem effective in treating dilutional hyponatremia, a frequent consequence of heart failure and of renal failure.

Data supporting the efficacy of the vasopressin receptor antagonists for this indication were presented in two posters at the annual meeting of the American Society of Nephrology. Satavaptan has not yet received Food and Drug Administration approval. Conivaptan, which was approved in 2005 for euvolemic hyponatremia, received approval in early 2007 for dilutional (hypervolemic) hyponatremia.

The conivaptan study was supported by Astellas Pharma US Inc. and the satavaptan study was supported by Sanofi Aventis. Both companies manufacture the vasopressin receptor antagonists.

Safety and efficacy in patients with heart failure (HF) are noteworthy findings because the current labeling for conivaptan says the drug is not indicated for the treatment of HF and should be used in these patients only when the expected benefit of increased serum sodium outweighs the potential adverse events.

Dr. Stephen R. Goldsmith of the University of Minnesota, Minneapolis, and his colleagues reported that conivaptan was effective at dosages of 20–40 mg/day, yielding significant increases in serum sodium concentration and in the area under the serum sodium concentration curve, compared with placebo.

The study was a retrospective analysis of two trials of conivaptan, one a randomized controlled trial and the other an open-label trial of patients with euvolemic and hypervolemic (dilutional) hyponatremia. For their presentations, they limited analysis to the 28 patients in the randomized controlled trial and the 69 patients in the open-label trial with hypervolemic hyponatremia.

The patients had serum sodium concentrations of 115–130 mEq/L and fasting blood glucose levels of less than 275 mg/dL. Their mean age was 71 years, and 62% had heart failure. They received either a 20-mg IV loading dose of conivaptan or placebo by 30-minute IV infusion followed by a continuous 4-day IV infusion.

Conivaptan infusion was associated with increases in serum sodium concentration over baseline of 4 mEq/L or more at all dosages. This increase occurred in a median of 58 hours at the lowest dosage (20 mg/day) and in a median of 24 hours at the higher dosages (40 and 80 mg/day). Most of the patients treated with conivaptan achieved at least a 6-mEq/L increase in serum sodium concentration over baseline or normal serum sodium concentrations at or above 135 mEq/L.

Significantly more serious adverse events occurred in those treated with conivaptan, compared with those on placebo. Deaths occurred at a similar frequency across all four groups. The most common adverse events were infusion-site phlebitis, infusion-site reactions, vomiting, and hypotension.

Conivaptan was as effective and as safe in patients with HF as it was in patients with other conditions. Still, the drug is intended to treat the hyponatremia that accompanies HF and not HF itself, Dr. Goldsmith emphasized in an interview. But, “since there is inevitable decongestion with a vaptan as a consequence of the free water excretion, one does, of course, 'treat' the [heart failure] to some extent.”

In the other presentation, Dr. Doron Aronson of Rambam Medical Center, Haifa, Israel, and colleagues found 50 mg/day of satavaptan was superior to placebo with respect to the sodium responder rate.

That study involved 118 patients randomized to receive either placebo or satavaptan at 25 mg/day or 50 mg/day. All of the patients had dilutional hyponatremia with serum sodium concentrations between 115 and 132 mEq/L. Heart failure was the cause of hyponatremia in 76% of the patients. The study excluded those with liver cirrhosis or the syndrome of inappropriate antidiuretic hormone secretion.

At the end of the 4-day double-blind period, 61% of the patients in the 50-mg group had a sodium response, compared with 27% in the placebo group, a significant difference. The sodium responder rate seemed higher in the 25-mg group than in the placebo group, but this figure did not quite reach statistical significance.

The median time to response was 3.3 days in the 25-mg group and 2.8 days in the 500-mg group, both significantly shorter than that for placebo, where the median time to response was more than 4 days.

Significantly more patients in the satavaptan groups than in the placebo group had overly rapid correction of serum sodium (increases of 12 mEq/L or more within 24 hours). Other adverse events in the satavaptan groups were atrial fibrillation, a prolonged QTc interval, hypotension, hypertension, and pyrexia.

SAN FRANCISCO — Satavaptan and conivaptan seem effective in treating dilutional hyponatremia, a frequent consequence of heart failure and of renal failure.

Data supporting the efficacy of the vasopressin receptor antagonists for this indication were presented in two posters at the annual meeting of the American Society of Nephrology. Satavaptan has not yet received Food and Drug Administration approval. Conivaptan, which was approved in 2005 for euvolemic hyponatremia, received approval in early 2007 for dilutional (hypervolemic) hyponatremia.

The conivaptan study was supported by Astellas Pharma US Inc. and the satavaptan study was supported by Sanofi Aventis. Both companies manufacture the vasopressin receptor antagonists.

Safety and efficacy in patients with heart failure (HF) are noteworthy findings because the current labeling for conivaptan says the drug is not indicated for the treatment of HF and should be used in these patients only when the expected benefit of increased serum sodium outweighs the potential adverse events.

Dr. Stephen R. Goldsmith of the University of Minnesota, Minneapolis, and his colleagues reported that conivaptan was effective at dosages of 20–40 mg/day, yielding significant increases in serum sodium concentration and in the area under the serum sodium concentration curve, compared with placebo.

The study was a retrospective analysis of two trials of conivaptan, one a randomized controlled trial and the other an open-label trial of patients with euvolemic and hypervolemic (dilutional) hyponatremia. For their presentations, they limited analysis to the 28 patients in the randomized controlled trial and the 69 patients in the open-label trial with hypervolemic hyponatremia.

The patients had serum sodium concentrations of 115–130 mEq/L and fasting blood glucose levels of less than 275 mg/dL. Their mean age was 71 years, and 62% had heart failure. They received either a 20-mg IV loading dose of conivaptan or placebo by 30-minute IV infusion followed by a continuous 4-day IV infusion.

Conivaptan infusion was associated with increases in serum sodium concentration over baseline of 4 mEq/L or more at all dosages. This increase occurred in a median of 58 hours at the lowest dosage (20 mg/day) and in a median of 24 hours at the higher dosages (40 and 80 mg/day). Most of the patients treated with conivaptan achieved at least a 6-mEq/L increase in serum sodium concentration over baseline or normal serum sodium concentrations at or above 135 mEq/L.

Significantly more serious adverse events occurred in those treated with conivaptan, compared with those on placebo. Deaths occurred at a similar frequency across all four groups. The most common adverse events were infusion-site phlebitis, infusion-site reactions, vomiting, and hypotension.

Conivaptan was as effective and as safe in patients with HF as it was in patients with other conditions. Still, the drug is intended to treat the hyponatremia that accompanies HF and not HF itself, Dr. Goldsmith emphasized in an interview. But, “since there is inevitable decongestion with a vaptan as a consequence of the free water excretion, one does, of course, 'treat' the [heart failure] to some extent.”

In the other presentation, Dr. Doron Aronson of Rambam Medical Center, Haifa, Israel, and colleagues found 50 mg/day of satavaptan was superior to placebo with respect to the sodium responder rate.

That study involved 118 patients randomized to receive either placebo or satavaptan at 25 mg/day or 50 mg/day. All of the patients had dilutional hyponatremia with serum sodium concentrations between 115 and 132 mEq/L. Heart failure was the cause of hyponatremia in 76% of the patients. The study excluded those with liver cirrhosis or the syndrome of inappropriate antidiuretic hormone secretion.

At the end of the 4-day double-blind period, 61% of the patients in the 50-mg group had a sodium response, compared with 27% in the placebo group, a significant difference. The sodium responder rate seemed higher in the 25-mg group than in the placebo group, but this figure did not quite reach statistical significance.

The median time to response was 3.3 days in the 25-mg group and 2.8 days in the 500-mg group, both significantly shorter than that for placebo, where the median time to response was more than 4 days.

Significantly more patients in the satavaptan groups than in the placebo group had overly rapid correction of serum sodium (increases of 12 mEq/L or more within 24 hours). Other adverse events in the satavaptan groups were atrial fibrillation, a prolonged QTc interval, hypotension, hypertension, and pyrexia.

Adolescent girls who begin dieting are twice as likely to begin smoking cigarettes regularly, according to a longitudinal study.

Among teenage boys, on the other hand, inactive dieters are significantly more likely to begin regular smoking, according to the study by Mildred M. Maldonado-Molina, Ph.D., of the University of Florida, Gainesville, and her colleagues (Am. J. Health Promot. 2007;22:25-32).

“It is important to consider dieting and its relation with other risk-taking behaviors in adolescents, such as smoking,” the investigators wrote. “Studies targeting the prevention and reduction of smoking … [also] need to acknowledge the initiation of dieting practices, the incidence of dieting and smoking during the same period of time, and how these two behaviors vary by gender.”

The study involved a subanalysis of data from the National Longitudinal Study of Adolescent Health, a school-based study of the health-related behaviors of adolescents in grades 7-12. A total of 9,632 students were interviewed between April 1994 and December 1995, and then reinterviewed a year later. Their mean age was 15.2 years at the first interview.

Investigators excluded 1,837 students who reported having already tried cigarettes regularly at the first interview, leaving 7,795 non-Hispanic whites and non-Hispanic blacks as the study population. The investigators excluded Hispanic students because of previous research indicating that smoking behaviors differ by ethnicity, and because the term “Hispanic” is broad, comprising several distinct ethnicities.

Of the students included in the study, 3,522 reported having tried cigarettes (although not regularly) at the first interview. These students were excluded from analyses of trying smoking but not from analyses of initiating regular smoking, which the investigators defined as at least one cigarette per day for 30 days.

Girls had a much higher prevalence of dieting than boys, 55% vs. 25%. After controlling for several covariates such as age, ethnicity, overweight, false perception about weight, and availability of cigarettes in the home, the investigators found several other important differences between boys and girls.

Among girls there was no significant association between dieting status or other covariates and trying smoking, but among boys those who were not overweight and those who had cigarettes available to them at home were both about 50% more likely to try smoking.

There were significant associations between dieting status and the initiation of regular smoking in both genders. Among girls, whites were three times as likely to begin regular smoking as blacks, those with cigarettes available in the home were 55% more likely to begin regular smoking than those without availability, and those who initiated dieting (that is, those who reported not dieting at the first interview but reported that they were at the second) were 94% more likely to start regular smoking than nondieters.

Among boys, whites were 74% more likely to begin regular smoking than blacks, those with cigarettes available in the home were 39% more likely to begin regular smoking than those without availability, and inactive dieters (those who reported dieting at the first interview but not the second) were 74% more likely to begin regular smoking than nondieters.

The study was supported by the National Institute on Drug Abuse. Investigators reported no conflicts of interest.

Adolescent girls who begin dieting are twice as likely to begin smoking cigarettes regularly, according to a longitudinal study.

Among teenage boys, on the other hand, inactive dieters are significantly more likely to begin regular smoking, according to the study by Mildred M. Maldonado-Molina, Ph.D., of the University of Florida, Gainesville, and her colleagues (Am. J. Health Promot. 2007;22:25-32).

“It is important to consider dieting and its relation with other risk-taking behaviors in adolescents, such as smoking,” the investigators wrote. “Studies targeting the prevention and reduction of smoking … [also] need to acknowledge the initiation of dieting practices, the incidence of dieting and smoking during the same period of time, and how these two behaviors vary by gender.”

The study involved a subanalysis of data from the National Longitudinal Study of Adolescent Health, a school-based study of the health-related behaviors of adolescents in grades 7-12. A total of 9,632 students were interviewed between April 1994 and December 1995, and then reinterviewed a year later. Their mean age was 15.2 years at the first interview.

Investigators excluded 1,837 students who reported having already tried cigarettes regularly at the first interview, leaving 7,795 non-Hispanic whites and non-Hispanic blacks as the study population. The investigators excluded Hispanic students because of previous research indicating that smoking behaviors differ by ethnicity, and because the term “Hispanic” is broad, comprising several distinct ethnicities.

Of the students included in the study, 3,522 reported having tried cigarettes (although not regularly) at the first interview. These students were excluded from analyses of trying smoking but not from analyses of initiating regular smoking, which the investigators defined as at least one cigarette per day for 30 days.

Girls had a much higher prevalence of dieting than boys, 55% vs. 25%. After controlling for several covariates such as age, ethnicity, overweight, false perception about weight, and availability of cigarettes in the home, the investigators found several other important differences between boys and girls.

Among girls there was no significant association between dieting status or other covariates and trying smoking, but among boys those who were not overweight and those who had cigarettes available to them at home were both about 50% more likely to try smoking.

There were significant associations between dieting status and the initiation of regular smoking in both genders. Among girls, whites were three times as likely to begin regular smoking as blacks, those with cigarettes available in the home were 55% more likely to begin regular smoking than those without availability, and those who initiated dieting (that is, those who reported not dieting at the first interview but reported that they were at the second) were 94% more likely to start regular smoking than nondieters.

Among boys, whites were 74% more likely to begin regular smoking than blacks, those with cigarettes available in the home were 39% more likely to begin regular smoking than those without availability, and inactive dieters (those who reported dieting at the first interview but not the second) were 74% more likely to begin regular smoking than nondieters.

The study was supported by the National Institute on Drug Abuse. Investigators reported no conflicts of interest.

Adolescent girls who begin dieting are twice as likely to begin smoking cigarettes regularly, according to a longitudinal study.

Among teenage boys, on the other hand, inactive dieters are significantly more likely to begin regular smoking, according to the study by Mildred M. Maldonado-Molina, Ph.D., of the University of Florida, Gainesville, and her colleagues (Am. J. Health Promot. 2007;22:25-32).

“It is important to consider dieting and its relation with other risk-taking behaviors in adolescents, such as smoking,” the investigators wrote. “Studies targeting the prevention and reduction of smoking … [also] need to acknowledge the initiation of dieting practices, the incidence of dieting and smoking during the same period of time, and how these two behaviors vary by gender.”

The study involved a subanalysis of data from the National Longitudinal Study of Adolescent Health, a school-based study of the health-related behaviors of adolescents in grades 7-12. A total of 9,632 students were interviewed between April 1994 and December 1995, and then reinterviewed a year later. Their mean age was 15.2 years at the first interview.

Investigators excluded 1,837 students who reported having already tried cigarettes regularly at the first interview, leaving 7,795 non-Hispanic whites and non-Hispanic blacks as the study population. The investigators excluded Hispanic students because of previous research indicating that smoking behaviors differ by ethnicity, and because the term “Hispanic” is broad, comprising several distinct ethnicities.

Of the students included in the study, 3,522 reported having tried cigarettes (although not regularly) at the first interview. These students were excluded from analyses of trying smoking but not from analyses of initiating regular smoking, which the investigators defined as at least one cigarette per day for 30 days.

Girls had a much higher prevalence of dieting than boys, 55% vs. 25%. After controlling for several covariates such as age, ethnicity, overweight, false perception about weight, and availability of cigarettes in the home, the investigators found several other important differences between boys and girls.

Among girls there was no significant association between dieting status or other covariates and trying smoking, but among boys those who were not overweight and those who had cigarettes available to them at home were both about 50% more likely to try smoking.

There were significant associations between dieting status and the initiation of regular smoking in both genders. Among girls, whites were three times as likely to begin regular smoking as blacks, those with cigarettes available in the home were 55% more likely to begin regular smoking than those without availability, and those who initiated dieting (that is, those who reported not dieting at the first interview but reported that they were at the second) were 94% more likely to start regular smoking than nondieters.

Among boys, whites were 74% more likely to begin regular smoking than blacks, those with cigarettes available in the home were 39% more likely to begin regular smoking than those without availability, and inactive dieters (those who reported dieting at the first interview but not the second) were 74% more likely to begin regular smoking than nondieters.

The study was supported by the National Institute on Drug Abuse. Investigators reported no conflicts of interest.

HUNTINGTON BEACH, CALIF. — In patients older than 55 years, multiplying a patient's age by the Shock Index—a ratio of heart rate to systolic blood pressure—provides a better predictor of 48-hour mortality than using the Shock Index alone, Dr. Ben L. Zarzaur said at the Academic Surgical Congress.

The Shock Index has long been known to provide a better predictive rule of thumb than heart rate or blood pressure alone, Dr. Zarzaur said. Better still are several measures such as the Injury Severity Score, the Revised Trauma Score, and the Trauma Injury Severity Score—but they use relatively complex equations and can be difficult to calculate in the resuscitation room.

In contrast, the Shock Index (SI) is simple to calculate but does not take into account the effect of patient age.

Dr. Zarzaur of the Presley Memorial Trauma Center at the University of Tennessee, Memphis, and his colleagues conducted a retrospective cohort study involving 16,077 patients, aged 18–81 years, who were admitted to the trauma center between 1996 and 2005. All were victims of blunt trauma, and all arrived with a palpable pulse of at least 10 beats per minute and a systolic blood pressure of at least 30 mm Hg.

The investigators excluded victims of neurotrauma, those who were admitted more than 24 hours after the injury, and those whose records lacked data on pulse rate and blood pressure.

They divided the patients into two groups: those who were 55 years old or younger and those older than 55 years. The mean age of the younger patients was 34 years and that of the older patients was 67 years.

The primary outcome measure was death within 48 hours, and the investigators used the need for a blood transfusion during that time period as a secondary outcome. They analyzed the area under the receiver operating curve (ROC), a statistical method that quantifies the balance between sensitivity and specificity, to determine which measures were best.

Among the younger patients, SI alone had a significantly larger ROC area than did pulse rate, systolic blood pressure, or age multiplied by SI. An SI score greater than 0.8 successfully predicted significant early mortality and transfusion in this age group.

In the older patients, on the other hand, age multiplied by SI had a larger ROC area than did the other measures. When age was multiplied by SI, a resulting product that was 50 or greater successfully predicted significant early mortality and transfusion in the older patients.

Dr. Zarzaur declared that he had no financial conflicts related to the study.

HUNTINGTON BEACH, CALIF. — In patients older than 55 years, multiplying a patient's age by the Shock Index—a ratio of heart rate to systolic blood pressure—provides a better predictor of 48-hour mortality than using the Shock Index alone, Dr. Ben L. Zarzaur said at the Academic Surgical Congress.

The Shock Index has long been known to provide a better predictive rule of thumb than heart rate or blood pressure alone, Dr. Zarzaur said. Better still are several measures such as the Injury Severity Score, the Revised Trauma Score, and the Trauma Injury Severity Score—but they use relatively complex equations and can be difficult to calculate in the resuscitation room.

In contrast, the Shock Index (SI) is simple to calculate but does not take into account the effect of patient age.

Dr. Zarzaur of the Presley Memorial Trauma Center at the University of Tennessee, Memphis, and his colleagues conducted a retrospective cohort study involving 16,077 patients, aged 18–81 years, who were admitted to the trauma center between 1996 and 2005. All were victims of blunt trauma, and all arrived with a palpable pulse of at least 10 beats per minute and a systolic blood pressure of at least 30 mm Hg.

The investigators excluded victims of neurotrauma, those who were admitted more than 24 hours after the injury, and those whose records lacked data on pulse rate and blood pressure.

They divided the patients into two groups: those who were 55 years old or younger and those older than 55 years. The mean age of the younger patients was 34 years and that of the older patients was 67 years.

The primary outcome measure was death within 48 hours, and the investigators used the need for a blood transfusion during that time period as a secondary outcome. They analyzed the area under the receiver operating curve (ROC), a statistical method that quantifies the balance between sensitivity and specificity, to determine which measures were best.

Among the younger patients, SI alone had a significantly larger ROC area than did pulse rate, systolic blood pressure, or age multiplied by SI. An SI score greater than 0.8 successfully predicted significant early mortality and transfusion in this age group.

In the older patients, on the other hand, age multiplied by SI had a larger ROC area than did the other measures. When age was multiplied by SI, a resulting product that was 50 or greater successfully predicted significant early mortality and transfusion in the older patients.

Dr. Zarzaur declared that he had no financial conflicts related to the study.

HUNTINGTON BEACH, CALIF. — In patients older than 55 years, multiplying a patient's age by the Shock Index—a ratio of heart rate to systolic blood pressure—provides a better predictor of 48-hour mortality than using the Shock Index alone, Dr. Ben L. Zarzaur said at the Academic Surgical Congress.

The Shock Index has long been known to provide a better predictive rule of thumb than heart rate or blood pressure alone, Dr. Zarzaur said. Better still are several measures such as the Injury Severity Score, the Revised Trauma Score, and the Trauma Injury Severity Score—but they use relatively complex equations and can be difficult to calculate in the resuscitation room.

In contrast, the Shock Index (SI) is simple to calculate but does not take into account the effect of patient age.

Dr. Zarzaur of the Presley Memorial Trauma Center at the University of Tennessee, Memphis, and his colleagues conducted a retrospective cohort study involving 16,077 patients, aged 18–81 years, who were admitted to the trauma center between 1996 and 2005. All were victims of blunt trauma, and all arrived with a palpable pulse of at least 10 beats per minute and a systolic blood pressure of at least 30 mm Hg.

The investigators excluded victims of neurotrauma, those who were admitted more than 24 hours after the injury, and those whose records lacked data on pulse rate and blood pressure.

They divided the patients into two groups: those who were 55 years old or younger and those older than 55 years. The mean age of the younger patients was 34 years and that of the older patients was 67 years.

The primary outcome measure was death within 48 hours, and the investigators used the need for a blood transfusion during that time period as a secondary outcome. They analyzed the area under the receiver operating curve (ROC), a statistical method that quantifies the balance between sensitivity and specificity, to determine which measures were best.

Among the younger patients, SI alone had a significantly larger ROC area than did pulse rate, systolic blood pressure, or age multiplied by SI. An SI score greater than 0.8 successfully predicted significant early mortality and transfusion in this age group.

In the older patients, on the other hand, age multiplied by SI had a larger ROC area than did the other measures. When age was multiplied by SI, a resulting product that was 50 or greater successfully predicted significant early mortality and transfusion in the older patients.

Dr. Zarzaur declared that he had no financial conflicts related to the study.

SAN FRANCISCO — A combined laparoscopic-endoscopic approach can be effective in treating difficult colonic polyps, Dr. Morris E. Franklin Jr. said at the annual meeting of the Society of Laparoendoscopic Surgeons.

In a case series of 144 patients from whom 190 polyps were removed during laparoscopically monitored colonoscopic polypectomy (LMCP), only 4% required conversion to full-thickness resection, said Dr. Franklin of the Texas Endosurgery Institute, San Antonio.

The patients resumed eating an average of 6 hours after the surgery, stayed in the hospital an average of 1.1 days, and returned to full activity in an average of 2 days. In all, 10% of the patients experienced minor complications and none had major complications.

During an average of 74 months of follow-up, no patients experienced a recurrence and only three needed reoperation, in each case because of a new polyp in a different segment.

“Our gastroenterologists now selectively send patients that have difficult polyps for this procedure,” Dr. Franklin said. The best candidates for LMCP are patients whose polyps are difficult to remove with a colonoscope alone. Removal may be difficult because of the size, location, or number of polyps.

Common indications include sessile broad-based polyps, very large polyps, or polyps that are difficult to reach, either because they are behind a fold or at a difficult angle. Dr. Franklin also finds the technique useful in cases of redundant sigmoid colon, which can make it difficult to get to polyps on the right side.

In performing the procedure, the laparoscopist works alongside the colonoscopist. To properly coordinate the procedure, it is crucial that each physician can see both monitors.

The laparoscopist begins by lysing the adhesions and mobilizing the colon. “We found that if we could straighten out the sigmoid, it makes passage of the colonoscope very rapid and therefore cuts down on the time for this procedure,” Dr. Franklin said.

The next step is to clamp the proximal bowel prior to the colonoscopy with polypectomy under microscopic guidance.

The laparoscopist monitors the serosal surface during the polypectomy, and sutures the polypectomy site if necessary. Occasionally the laparoscopist will perform a colotomy for a very large polyp that can't be removed with the colonoscope alone. Sometimes the laparoscopist will perform a full-thickness or segmental resection, particularly if the polyp appears likely to be cancerous. Frozen section evaluation is obtained on each specimen.

Dr. Franklin noted that the one disadvantage of LMCP is that the surgeon is reimbursed at a higher rate for segmental resections, but “if we're doing something good for the patients, that probably it's beneficial to all.”

Dr. Franklin disclosed receiving research funds, serving as a consultant, and serving on the speaker's bureau for several manufactures of medical devices.

SAN FRANCISCO — A combined laparoscopic-endoscopic approach can be effective in treating difficult colonic polyps, Dr. Morris E. Franklin Jr. said at the annual meeting of the Society of Laparoendoscopic Surgeons.

In a case series of 144 patients from whom 190 polyps were removed during laparoscopically monitored colonoscopic polypectomy (LMCP), only 4% required conversion to full-thickness resection, said Dr. Franklin of the Texas Endosurgery Institute, San Antonio.

The patients resumed eating an average of 6 hours after the surgery, stayed in the hospital an average of 1.1 days, and returned to full activity in an average of 2 days. In all, 10% of the patients experienced minor complications and none had major complications.

During an average of 74 months of follow-up, no patients experienced a recurrence and only three needed reoperation, in each case because of a new polyp in a different segment.

“Our gastroenterologists now selectively send patients that have difficult polyps for this procedure,” Dr. Franklin said. The best candidates for LMCP are patients whose polyps are difficult to remove with a colonoscope alone. Removal may be difficult because of the size, location, or number of polyps.

Common indications include sessile broad-based polyps, very large polyps, or polyps that are difficult to reach, either because they are behind a fold or at a difficult angle. Dr. Franklin also finds the technique useful in cases of redundant sigmoid colon, which can make it difficult to get to polyps on the right side.

In performing the procedure, the laparoscopist works alongside the colonoscopist. To properly coordinate the procedure, it is crucial that each physician can see both monitors.

The laparoscopist begins by lysing the adhesions and mobilizing the colon. “We found that if we could straighten out the sigmoid, it makes passage of the colonoscope very rapid and therefore cuts down on the time for this procedure,” Dr. Franklin said.

The next step is to clamp the proximal bowel prior to the colonoscopy with polypectomy under microscopic guidance.

The laparoscopist monitors the serosal surface during the polypectomy, and sutures the polypectomy site if necessary. Occasionally the laparoscopist will perform a colotomy for a very large polyp that can't be removed with the colonoscope alone. Sometimes the laparoscopist will perform a full-thickness or segmental resection, particularly if the polyp appears likely to be cancerous. Frozen section evaluation is obtained on each specimen.

Dr. Franklin noted that the one disadvantage of LMCP is that the surgeon is reimbursed at a higher rate for segmental resections, but “if we're doing something good for the patients, that probably it's beneficial to all.”

Dr. Franklin disclosed receiving research funds, serving as a consultant, and serving on the speaker's bureau for several manufactures of medical devices.

SAN FRANCISCO — A combined laparoscopic-endoscopic approach can be effective in treating difficult colonic polyps, Dr. Morris E. Franklin Jr. said at the annual meeting of the Society of Laparoendoscopic Surgeons.

In a case series of 144 patients from whom 190 polyps were removed during laparoscopically monitored colonoscopic polypectomy (LMCP), only 4% required conversion to full-thickness resection, said Dr. Franklin of the Texas Endosurgery Institute, San Antonio.

The patients resumed eating an average of 6 hours after the surgery, stayed in the hospital an average of 1.1 days, and returned to full activity in an average of 2 days. In all, 10% of the patients experienced minor complications and none had major complications.

During an average of 74 months of follow-up, no patients experienced a recurrence and only three needed reoperation, in each case because of a new polyp in a different segment.

“Our gastroenterologists now selectively send patients that have difficult polyps for this procedure,” Dr. Franklin said. The best candidates for LMCP are patients whose polyps are difficult to remove with a colonoscope alone. Removal may be difficult because of the size, location, or number of polyps.

Common indications include sessile broad-based polyps, very large polyps, or polyps that are difficult to reach, either because they are behind a fold or at a difficult angle. Dr. Franklin also finds the technique useful in cases of redundant sigmoid colon, which can make it difficult to get to polyps on the right side.

In performing the procedure, the laparoscopist works alongside the colonoscopist. To properly coordinate the procedure, it is crucial that each physician can see both monitors.

The laparoscopist begins by lysing the adhesions and mobilizing the colon. “We found that if we could straighten out the sigmoid, it makes passage of the colonoscope very rapid and therefore cuts down on the time for this procedure,” Dr. Franklin said.

The next step is to clamp the proximal bowel prior to the colonoscopy with polypectomy under microscopic guidance.

The laparoscopist monitors the serosal surface during the polypectomy, and sutures the polypectomy site if necessary. Occasionally the laparoscopist will perform a colotomy for a very large polyp that can't be removed with the colonoscope alone. Sometimes the laparoscopist will perform a full-thickness or segmental resection, particularly if the polyp appears likely to be cancerous. Frozen section evaluation is obtained on each specimen.

Dr. Franklin noted that the one disadvantage of LMCP is that the surgeon is reimbursed at a higher rate for segmental resections, but “if we're doing something good for the patients, that probably it's beneficial to all.”

Dr. Franklin disclosed receiving research funds, serving as a consultant, and serving on the speaker's bureau for several manufactures of medical devices.

The Food and Drug Administration has recently approved the first rapid blood test for methicillin-resistant Staphylococcus aureus.

The test, which is called the BD GeneOhm Staph SR, can detect both methicillin-resistant S. aureus (MRSA) and more common and less dangerous strains of the staph bacterium in just 2 hours.

Manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J., the test uses polymerase chain reaction techniques to detect a gene sequence that is unique to the drug-resistant strain of S. aureus. Traditional microbiology-based cultures require 24–72 hours to return results.

In 2005, BD received approval for a similar test, the BD GeneOhm MRSA Assay, which can detect MRSA in nasal specimens. That test is used primarily to screen for the presence of asymptomatic MRSA in patients who are about to enter the hospital so that preventive measures can be taken.

The new blood test will be used primarily to choose among treatment options for patients who are already suspected of having an invasive staph infection.

According to BD spokesperson Barbara Kalavik, the company plans to begin marketing the BD GeneOhm Staph SR as soon as next week in the United States. Marketing began in Europe in late December 2007.

Both versions of the test require the use of a specialized instrument, called a PCR-thermocycler, which costs about $35,000. Not counting the capital cost of this equipment, the new BD GeneOhm Staph SR blood test is expected to cost about $35 per patient, compared with about $25 for the older BD GeneOhm MRSA Assay.

The approval was based on the results of a multicenter clinical trial that demonstrated that the BD GeneOhm Staph SR correctly identified 100% of the MRSA-positive specimens and more than 98% of other staph infections.

According to the FDA statement, "in order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient's response to treatment."

In addition, the FDA warned that the test results should not be used as the sole basis for diagnosis, since positive results may reflect the bacteria's presence in patients who have already been successfully treated for staph infections.

Furthermore, the agency cautioned, the test will not rule out other complicating conditions or infections.

The Food and Drug Administration has recently approved the first rapid blood test for methicillin-resistant Staphylococcus aureus.

The test, which is called the BD GeneOhm Staph SR, can detect both methicillin-resistant S. aureus (MRSA) and more common and less dangerous strains of the staph bacterium in just 2 hours.

Manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J., the test uses polymerase chain reaction techniques to detect a gene sequence that is unique to the drug-resistant strain of S. aureus. Traditional microbiology-based cultures require 24–72 hours to return results.

In 2005, BD received approval for a similar test, the BD GeneOhm MRSA Assay, which can detect MRSA in nasal specimens. That test is used primarily to screen for the presence of asymptomatic MRSA in patients who are about to enter the hospital so that preventive measures can be taken.

The new blood test will be used primarily to choose among treatment options for patients who are already suspected of having an invasive staph infection.

According to BD spokesperson Barbara Kalavik, the company plans to begin marketing the BD GeneOhm Staph SR as soon as next week in the United States. Marketing began in Europe in late December 2007.

Both versions of the test require the use of a specialized instrument, called a PCR-thermocycler, which costs about $35,000. Not counting the capital cost of this equipment, the new BD GeneOhm Staph SR blood test is expected to cost about $35 per patient, compared with about $25 for the older BD GeneOhm MRSA Assay.

The approval was based on the results of a multicenter clinical trial that demonstrated that the BD GeneOhm Staph SR correctly identified 100% of the MRSA-positive specimens and more than 98% of other staph infections.

According to the FDA statement, "in order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient's response to treatment."

In addition, the FDA warned that the test results should not be used as the sole basis for diagnosis, since positive results may reflect the bacteria's presence in patients who have already been successfully treated for staph infections.

Furthermore, the agency cautioned, the test will not rule out other complicating conditions or infections.

The Food and Drug Administration has recently approved the first rapid blood test for methicillin-resistant Staphylococcus aureus.

The test, which is called the BD GeneOhm Staph SR, can detect both methicillin-resistant S. aureus (MRSA) and more common and less dangerous strains of the staph bacterium in just 2 hours.

Manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J., the test uses polymerase chain reaction techniques to detect a gene sequence that is unique to the drug-resistant strain of S. aureus. Traditional microbiology-based cultures require 24–72 hours to return results.

In 2005, BD received approval for a similar test, the BD GeneOhm MRSA Assay, which can detect MRSA in nasal specimens. That test is used primarily to screen for the presence of asymptomatic MRSA in patients who are about to enter the hospital so that preventive measures can be taken.

The new blood test will be used primarily to choose among treatment options for patients who are already suspected of having an invasive staph infection.

According to BD spokesperson Barbara Kalavik, the company plans to begin marketing the BD GeneOhm Staph SR as soon as next week in the United States. Marketing began in Europe in late December 2007.

Both versions of the test require the use of a specialized instrument, called a PCR-thermocycler, which costs about $35,000. Not counting the capital cost of this equipment, the new BD GeneOhm Staph SR blood test is expected to cost about $35 per patient, compared with about $25 for the older BD GeneOhm MRSA Assay.

The approval was based on the results of a multicenter clinical trial that demonstrated that the BD GeneOhm Staph SR correctly identified 100% of the MRSA-positive specimens and more than 98% of other staph infections.

According to the FDA statement, "in order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient's response to treatment."

In addition, the FDA warned that the test results should not be used as the sole basis for diagnosis, since positive results may reflect the bacteria's presence in patients who have already been successfully treated for staph infections.

Furthermore, the agency cautioned, the test will not rule out other complicating conditions or infections.

Because of their increased risk of developing impaired glucose tolerance and type 2 diabetes, all women with polycystic ovary syndrome should be screened with a 2-hour oral glucose tolerance test, and that test should be repeated every 2 years, according to a statement from the Androgen Excess Society.

The position statement was developed by an expert multidisciplinary panel from the Medical College of Virginia, Virginia Commonwealth University, Richmond, which conducted a systematic review of the published, peer-reviewed medical literature on the prevalence and risk factors for impaired glucose tolerance in women with polycystic ovary syndrome (J. Clin. Endocrinol. Metab. 2007;92:4546-56).

The recommendation for a full oral glucose tolerance test (OGTT) for all patients with polycystic ovary syndrome (PCOS) goes beyond screening recommendations issued by other professional organizations. Most recommend it only in obese women with PCOS or those with a family history of type 2 diabetes or insulin resistance.

The panel focused on studies indicating that both lean and obese women with PCOS are at increased risk of developing impaired glucose tolerance and diabetes. It also noted that a number of studies show that a finding of impaired fasting glucose is not a useful substitute for an OGTT, because about a third of individuals with type 2 diabetes have normal fasting glucose. Furthermore, impaired glucose tolerance, but not impaired fasting glucose, is a strong predictor of cardiovascular disease and premature mortality.

“The position statement makes a valuable contribution to the health care of women with PCOS by recognizing its strong association with insulin resistance and type 2 diabetes,” Dr. Rhoda H. Cobin said in an interview. Dr. Cobin, a past president of both the American College of Endocrinology and the American Association of Clinical Endocrinologists (AACE), chaired the panel that developed the AACE's 2005 PCOSposition statement (Endocr. Pract. 2005;11:126-34).

However, an oral glucose tolerance test may not be feasible in all clinical settings, which is why “the AACE statement did not make it mandatory but, based on the same evidence, settled for the directive to look for type 2 diabetes, impaired fasting glucose, or impaired glucose tolerance in all PCOS women, using whatever method possible,” Dr. Cobin said. “I [agree] that not only obese women should be tested, but that lean PCOS women may have insulin resistance and diabetes, while obesity exacerbates the situation.”

The position statement from the Androgen Excess Society (AES) notes that several AES board members disagreed with the recommendation to screen all women with PCOS with an OGTT. The minority report says evidence on the risk of impaired glucose tolerance in lean PCOS women is “limited and still emerging.” Those board members recommended an OGTT only in PCOS patients whose body mass index was 30 kg/m

The AES statement makes several recommendations on the prevention, screening, and treatment of impaired glucose tolerance in patients with PCOS. It suggested the OGTT be repeated once every 2 years or even earlier if the patient has additional risk factors. Patients with impaired glucose tolerance should be screened annually for the development of diabetes.

Intensive lifestyle modification and weight loss should be the mainstay of treatment for all patients with PCOS and impaired glucose tolerance. Insulin-sensitizing agents such as metformin and the thiazolidinediones should also be considered.

The panel also recommended that adolescents with PCOS should, like their adult counterparts, be screened with an OGTT every 2 years and should be treated with intensive lifestyle modification, including diet and moderate exercise. Insulin-sensitizing agents should be considered, but should not be mandated until there have been well-designed, randomized controlled trials demonstrating their efficacy.

Dr. Cobin said she saw few arguments against the OGTT recommendations. “The only negatives are inconvenience and [to a small degree] cost [but] the cost factor is far outweighed by the cost of undiagnosed insulin resistance and diabetes.”

Because of their increased risk of developing impaired glucose tolerance and type 2 diabetes, all women with polycystic ovary syndrome should be screened with a 2-hour oral glucose tolerance test, and that test should be repeated every 2 years, according to a statement from the Androgen Excess Society.

The position statement was developed by an expert multidisciplinary panel from the Medical College of Virginia, Virginia Commonwealth University, Richmond, which conducted a systematic review of the published, peer-reviewed medical literature on the prevalence and risk factors for impaired glucose tolerance in women with polycystic ovary syndrome (J. Clin. Endocrinol. Metab. 2007;92:4546-56).

The recommendation for a full oral glucose tolerance test (OGTT) for all patients with polycystic ovary syndrome (PCOS) goes beyond screening recommendations issued by other professional organizations. Most recommend it only in obese women with PCOS or those with a family history of type 2 diabetes or insulin resistance.

The panel focused on studies indicating that both lean and obese women with PCOS are at increased risk of developing impaired glucose tolerance and diabetes. It also noted that a number of studies show that a finding of impaired fasting glucose is not a useful substitute for an OGTT, because about a third of individuals with type 2 diabetes have normal fasting glucose. Furthermore, impaired glucose tolerance, but not impaired fasting glucose, is a strong predictor of cardiovascular disease and premature mortality.

“The position statement makes a valuable contribution to the health care of women with PCOS by recognizing its strong association with insulin resistance and type 2 diabetes,” Dr. Rhoda H. Cobin said in an interview. Dr. Cobin, a past president of both the American College of Endocrinology and the American Association of Clinical Endocrinologists (AACE), chaired the panel that developed the AACE's 2005 PCOSposition statement (Endocr. Pract. 2005;11:126-34).

However, an oral glucose tolerance test may not be feasible in all clinical settings, which is why “the AACE statement did not make it mandatory but, based on the same evidence, settled for the directive to look for type 2 diabetes, impaired fasting glucose, or impaired glucose tolerance in all PCOS women, using whatever method possible,” Dr. Cobin said. “I [agree] that not only obese women should be tested, but that lean PCOS women may have insulin resistance and diabetes, while obesity exacerbates the situation.”

The position statement from the Androgen Excess Society (AES) notes that several AES board members disagreed with the recommendation to screen all women with PCOS with an OGTT. The minority report says evidence on the risk of impaired glucose tolerance in lean PCOS women is “limited and still emerging.” Those board members recommended an OGTT only in PCOS patients whose body mass index was 30 kg/m

The AES statement makes several recommendations on the prevention, screening, and treatment of impaired glucose tolerance in patients with PCOS. It suggested the OGTT be repeated once every 2 years or even earlier if the patient has additional risk factors. Patients with impaired glucose tolerance should be screened annually for the development of diabetes.

Intensive lifestyle modification and weight loss should be the mainstay of treatment for all patients with PCOS and impaired glucose tolerance. Insulin-sensitizing agents such as metformin and the thiazolidinediones should also be considered.

The panel also recommended that adolescents with PCOS should, like their adult counterparts, be screened with an OGTT every 2 years and should be treated with intensive lifestyle modification, including diet and moderate exercise. Insulin-sensitizing agents should be considered, but should not be mandated until there have been well-designed, randomized controlled trials demonstrating their efficacy.

Dr. Cobin said she saw few arguments against the OGTT recommendations. “The only negatives are inconvenience and [to a small degree] cost [but] the cost factor is far outweighed by the cost of undiagnosed insulin resistance and diabetes.”

Because of their increased risk of developing impaired glucose tolerance and type 2 diabetes, all women with polycystic ovary syndrome should be screened with a 2-hour oral glucose tolerance test, and that test should be repeated every 2 years, according to a statement from the Androgen Excess Society.

The position statement was developed by an expert multidisciplinary panel from the Medical College of Virginia, Virginia Commonwealth University, Richmond, which conducted a systematic review of the published, peer-reviewed medical literature on the prevalence and risk factors for impaired glucose tolerance in women with polycystic ovary syndrome (J. Clin. Endocrinol. Metab. 2007;92:4546-56).

The recommendation for a full oral glucose tolerance test (OGTT) for all patients with polycystic ovary syndrome (PCOS) goes beyond screening recommendations issued by other professional organizations. Most recommend it only in obese women with PCOS or those with a family history of type 2 diabetes or insulin resistance.

The panel focused on studies indicating that both lean and obese women with PCOS are at increased risk of developing impaired glucose tolerance and diabetes. It also noted that a number of studies show that a finding of impaired fasting glucose is not a useful substitute for an OGTT, because about a third of individuals with type 2 diabetes have normal fasting glucose. Furthermore, impaired glucose tolerance, but not impaired fasting glucose, is a strong predictor of cardiovascular disease and premature mortality.

“The position statement makes a valuable contribution to the health care of women with PCOS by recognizing its strong association with insulin resistance and type 2 diabetes,” Dr. Rhoda H. Cobin said in an interview. Dr. Cobin, a past president of both the American College of Endocrinology and the American Association of Clinical Endocrinologists (AACE), chaired the panel that developed the AACE's 2005 PCOSposition statement (Endocr. Pract. 2005;11:126-34).

However, an oral glucose tolerance test may not be feasible in all clinical settings, which is why “the AACE statement did not make it mandatory but, based on the same evidence, settled for the directive to look for type 2 diabetes, impaired fasting glucose, or impaired glucose tolerance in all PCOS women, using whatever method possible,” Dr. Cobin said. “I [agree] that not only obese women should be tested, but that lean PCOS women may have insulin resistance and diabetes, while obesity exacerbates the situation.”

The position statement from the Androgen Excess Society (AES) notes that several AES board members disagreed with the recommendation to screen all women with PCOS with an OGTT. The minority report says evidence on the risk of impaired glucose tolerance in lean PCOS women is “limited and still emerging.” Those board members recommended an OGTT only in PCOS patients whose body mass index was 30 kg/m

The AES statement makes several recommendations on the prevention, screening, and treatment of impaired glucose tolerance in patients with PCOS. It suggested the OGTT be repeated once every 2 years or even earlier if the patient has additional risk factors. Patients with impaired glucose tolerance should be screened annually for the development of diabetes.

Intensive lifestyle modification and weight loss should be the mainstay of treatment for all patients with PCOS and impaired glucose tolerance. Insulin-sensitizing agents such as metformin and the thiazolidinediones should also be considered.

The panel also recommended that adolescents with PCOS should, like their adult counterparts, be screened with an OGTT every 2 years and should be treated with intensive lifestyle modification, including diet and moderate exercise. Insulin-sensitizing agents should be considered, but should not be mandated until there have been well-designed, randomized controlled trials demonstrating their efficacy.

Dr. Cobin said she saw few arguments against the OGTT recommendations. “The only negatives are inconvenience and [to a small degree] cost [but] the cost factor is far outweighed by the cost of undiagnosed insulin resistance and diabetes.”

The Food and Drug Administration has approved the first rapid blood test for methicillin-resistant Staphylococcus aureus.

The test, called the BD GeneOhm Staph SR, can detect both methicillin-resistant S. aureus (MRSA) and more common and less dangerous strains of the staph bacterium in just 2 hours. Manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J., the test uses polymerase chain reaction techniques to detect a gene sequence unique to the drug-resistant strain of S. aureus. Traditional microbiology-based cultures require 24–72 hours to return results.

In 2005, BD received approval for a similar test, the BD GeneOhm MRSA Assay, which detects MRSA in nasal specimens. That test is used primarily to screen patients about to enter the hospital for the presence of asymptomatic MRSA so preventive measures can be taken.

The new blood test will be used primarily to choose among treatment options for patients already suspected of having an invasive staph infection.

According to BD spokesperson Barbara Kalavik, the company plans to begin marketing the BD GeneOhm Staph SR as soon as next week in the United States. Marketing began in Europe in late December 2007.

Both versions of the test require the use of a specialized instrument, called a PCR-thermocycler, which costs about $35,000. Not counting the capital cost of this equipment, the new BD GeneOhm Staph SR blood test is expected to cost about $35 per patient, compared with about $25 for the older BD GeneOhm MRSA Assay.

The approval was based on the results of a multicenter clinical trial that demonstrated that the BD GeneOhm Staph SR correctly identified 100% of the MRSA-positive specimens and more than 98% of other staph infections.

According to the FDA, “In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient's response to treatment.”

In addition, the FDA warned that test results should not be used as the sole basis for diagnosis, since positive results may reflect the bacteria's presence in patients who have already been successfully treated for staph infections. Furthermore, the agency cautioned, the test will not rule out other complicating conditions or infections.

The Food and Drug Administration has approved the first rapid blood test for methicillin-resistant Staphylococcus aureus.

The test, called the BD GeneOhm Staph SR, can detect both methicillin-resistant S. aureus (MRSA) and more common and less dangerous strains of the staph bacterium in just 2 hours. Manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J., the test uses polymerase chain reaction techniques to detect a gene sequence unique to the drug-resistant strain of S. aureus. Traditional microbiology-based cultures require 24–72 hours to return results.

In 2005, BD received approval for a similar test, the BD GeneOhm MRSA Assay, which detects MRSA in nasal specimens. That test is used primarily to screen patients about to enter the hospital for the presence of asymptomatic MRSA so preventive measures can be taken.

The new blood test will be used primarily to choose among treatment options for patients already suspected of having an invasive staph infection.

According to BD spokesperson Barbara Kalavik, the company plans to begin marketing the BD GeneOhm Staph SR as soon as next week in the United States. Marketing began in Europe in late December 2007.

Both versions of the test require the use of a specialized instrument, called a PCR-thermocycler, which costs about $35,000. Not counting the capital cost of this equipment, the new BD GeneOhm Staph SR blood test is expected to cost about $35 per patient, compared with about $25 for the older BD GeneOhm MRSA Assay.

The approval was based on the results of a multicenter clinical trial that demonstrated that the BD GeneOhm Staph SR correctly identified 100% of the MRSA-positive specimens and more than 98% of other staph infections.

According to the FDA, “In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient's response to treatment.”

In addition, the FDA warned that test results should not be used as the sole basis for diagnosis, since positive results may reflect the bacteria's presence in patients who have already been successfully treated for staph infections. Furthermore, the agency cautioned, the test will not rule out other complicating conditions or infections.

The Food and Drug Administration has approved the first rapid blood test for methicillin-resistant Staphylococcus aureus.

The test, called the BD GeneOhm Staph SR, can detect both methicillin-resistant S. aureus (MRSA) and more common and less dangerous strains of the staph bacterium in just 2 hours. Manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J., the test uses polymerase chain reaction techniques to detect a gene sequence unique to the drug-resistant strain of S. aureus. Traditional microbiology-based cultures require 24–72 hours to return results.

In 2005, BD received approval for a similar test, the BD GeneOhm MRSA Assay, which detects MRSA in nasal specimens. That test is used primarily to screen patients about to enter the hospital for the presence of asymptomatic MRSA so preventive measures can be taken.

The new blood test will be used primarily to choose among treatment options for patients already suspected of having an invasive staph infection.

According to BD spokesperson Barbara Kalavik, the company plans to begin marketing the BD GeneOhm Staph SR as soon as next week in the United States. Marketing began in Europe in late December 2007.

Both versions of the test require the use of a specialized instrument, called a PCR-thermocycler, which costs about $35,000. Not counting the capital cost of this equipment, the new BD GeneOhm Staph SR blood test is expected to cost about $35 per patient, compared with about $25 for the older BD GeneOhm MRSA Assay.

The approval was based on the results of a multicenter clinical trial that demonstrated that the BD GeneOhm Staph SR correctly identified 100% of the MRSA-positive specimens and more than 98% of other staph infections.

According to the FDA, “In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient's response to treatment.”

In addition, the FDA warned that test results should not be used as the sole basis for diagnosis, since positive results may reflect the bacteria's presence in patients who have already been successfully treated for staph infections. Furthermore, the agency cautioned, the test will not rule out other complicating conditions or infections.