Kerri Wachter

NEW YORK – Patients treated with carvedilol not only had a reduced frequency of intradialytic hypertension but showed improvements in endothelial cell function, in a small study.

After 8 weeks of treatment with carvedilol, mean systolic postdialysis blood pressure dropped from 159 mm Hg at baseline to 142 mm Hg, reported Dr. Julia Inrig, assistant professor of nephrology at the University of Texas Southwestern Medical Center in Dallas.

"Our laboratory has been very interested in this phenomenon of intradialytic hypertension," she said at the annual meeting of the American Society of Hypertension. When most patents come for dialysis, there is a gradual reduction in their systolic blood pressure. "However, up to 20% of patients have this gradual increase in their systolic blood pressure during their dialysis. So they leave their dialysis session much more hypertensive than when they showed up, despite similar amounts of fluid removed."

In addition, "we’ve identified that this is an important prognostic indicator." In a cohort of 450 dialysis patients, those with increased blood pressure during dialysis had an almost twofold increased odds for hospitalization or death at 6 months (Kidney Int. 2007;71:454-61).

The researchers in the Mechanisms and Treatment of Intradialytic Hypertension (MATCH) pilot study prospectively enrolled 25 hemodialysis patients with intradialytic hypertension into an open-label intervention study. Once patients were accepted into the study, they underwent baseline testing, including 44-hour ambulatory blood pressure, lipids, albumin, sodium, and C-reactive protein, as well as postdialysis endothelin-1, asymmetric dimethylarginine, endothelial progenitor cells, pulse-wave velocity, and brachial artery flow. In 8 weeks, the baseline lab work was repeated.

Patients were started on carvedilol 6.25 mg twice daily, and the dose was eventually titrated to 50 mg twice daily. "Our goal was to reach a delta [systolic] blood pressure less than zero with regard to their postdialysis blood pressure no longer increasing," said Dr. Inrig. However, she and her colleagues were also targeting a postdialysis systolic BP of less than 130 mm Hg as an alternate goal.

The average patient age was 54 years, and the group was 80% male. Roughly two-thirds of the population was Hispanic (64%), and more than a third was black (36%). Almost all (88%) had diabetes, and 32% had cardiovascular disease. Many of the patients were on ACE inhibitors or angiotensin II receptor blockers (64%), beta-blockers (68%), or calcium channel blockers (60%) at baseline.

Mean predialysis blood pressure was roughly the same regardless of carvedilol treatment (144 mm Hg vs. 146 mm Hg). The frequency of intradialytic hypertension declined from 77% of hemodialysis sessions at baseline to 28% by the study’s end, a significant difference.

Treatment with carvedilol showed a trend toward improvement of brachial artery flow–mediated dilation. However there was no change in C-reactive protein or pulse-wave velocity.

"With regard to safety, patients tolerated carvedilol fairly well," said Dr. Inrig. There was a low incidence of side effects.

Dr. Inrig reported that she has received an investigator-initiated research grant from Genzyme. She has also participated in industry-sponsored research for Keryx Biopharmaceuticals.

NEW YORK – Patients treated with carvedilol not only had a reduced frequency of intradialytic hypertension but showed improvements in endothelial cell function, in a small study.

After 8 weeks of treatment with carvedilol, mean systolic postdialysis blood pressure dropped from 159 mm Hg at baseline to 142 mm Hg, reported Dr. Julia Inrig, assistant professor of nephrology at the University of Texas Southwestern Medical Center in Dallas.

"Our laboratory has been very interested in this phenomenon of intradialytic hypertension," she said at the annual meeting of the American Society of Hypertension. When most patents come for dialysis, there is a gradual reduction in their systolic blood pressure. "However, up to 20% of patients have this gradual increase in their systolic blood pressure during their dialysis. So they leave their dialysis session much more hypertensive than when they showed up, despite similar amounts of fluid removed."

In addition, "we’ve identified that this is an important prognostic indicator." In a cohort of 450 dialysis patients, those with increased blood pressure during dialysis had an almost twofold increased odds for hospitalization or death at 6 months (Kidney Int. 2007;71:454-61).

The researchers in the Mechanisms and Treatment of Intradialytic Hypertension (MATCH) pilot study prospectively enrolled 25 hemodialysis patients with intradialytic hypertension into an open-label intervention study. Once patients were accepted into the study, they underwent baseline testing, including 44-hour ambulatory blood pressure, lipids, albumin, sodium, and C-reactive protein, as well as postdialysis endothelin-1, asymmetric dimethylarginine, endothelial progenitor cells, pulse-wave velocity, and brachial artery flow. In 8 weeks, the baseline lab work was repeated.

Patients were started on carvedilol 6.25 mg twice daily, and the dose was eventually titrated to 50 mg twice daily. "Our goal was to reach a delta [systolic] blood pressure less than zero with regard to their postdialysis blood pressure no longer increasing," said Dr. Inrig. However, she and her colleagues were also targeting a postdialysis systolic BP of less than 130 mm Hg as an alternate goal.

The average patient age was 54 years, and the group was 80% male. Roughly two-thirds of the population was Hispanic (64%), and more than a third was black (36%). Almost all (88%) had diabetes, and 32% had cardiovascular disease. Many of the patients were on ACE inhibitors or angiotensin II receptor blockers (64%), beta-blockers (68%), or calcium channel blockers (60%) at baseline.

Mean predialysis blood pressure was roughly the same regardless of carvedilol treatment (144 mm Hg vs. 146 mm Hg). The frequency of intradialytic hypertension declined from 77% of hemodialysis sessions at baseline to 28% by the study’s end, a significant difference.

Treatment with carvedilol showed a trend toward improvement of brachial artery flow–mediated dilation. However there was no change in C-reactive protein or pulse-wave velocity.

"With regard to safety, patients tolerated carvedilol fairly well," said Dr. Inrig. There was a low incidence of side effects.

Dr. Inrig reported that she has received an investigator-initiated research grant from Genzyme. She has also participated in industry-sponsored research for Keryx Biopharmaceuticals.

NEW YORK – Patients treated with carvedilol not only had a reduced frequency of intradialytic hypertension but showed improvements in endothelial cell function, in a small study.

After 8 weeks of treatment with carvedilol, mean systolic postdialysis blood pressure dropped from 159 mm Hg at baseline to 142 mm Hg, reported Dr. Julia Inrig, assistant professor of nephrology at the University of Texas Southwestern Medical Center in Dallas.

"Our laboratory has been very interested in this phenomenon of intradialytic hypertension," she said at the annual meeting of the American Society of Hypertension. When most patents come for dialysis, there is a gradual reduction in their systolic blood pressure. "However, up to 20% of patients have this gradual increase in their systolic blood pressure during their dialysis. So they leave their dialysis session much more hypertensive than when they showed up, despite similar amounts of fluid removed."

In addition, "we’ve identified that this is an important prognostic indicator." In a cohort of 450 dialysis patients, those with increased blood pressure during dialysis had an almost twofold increased odds for hospitalization or death at 6 months (Kidney Int. 2007;71:454-61).

The researchers in the Mechanisms and Treatment of Intradialytic Hypertension (MATCH) pilot study prospectively enrolled 25 hemodialysis patients with intradialytic hypertension into an open-label intervention study. Once patients were accepted into the study, they underwent baseline testing, including 44-hour ambulatory blood pressure, lipids, albumin, sodium, and C-reactive protein, as well as postdialysis endothelin-1, asymmetric dimethylarginine, endothelial progenitor cells, pulse-wave velocity, and brachial artery flow. In 8 weeks, the baseline lab work was repeated.

Patients were started on carvedilol 6.25 mg twice daily, and the dose was eventually titrated to 50 mg twice daily. "Our goal was to reach a delta [systolic] blood pressure less than zero with regard to their postdialysis blood pressure no longer increasing," said Dr. Inrig. However, she and her colleagues were also targeting a postdialysis systolic BP of less than 130 mm Hg as an alternate goal.

The average patient age was 54 years, and the group was 80% male. Roughly two-thirds of the population was Hispanic (64%), and more than a third was black (36%). Almost all (88%) had diabetes, and 32% had cardiovascular disease. Many of the patients were on ACE inhibitors or angiotensin II receptor blockers (64%), beta-blockers (68%), or calcium channel blockers (60%) at baseline.

Mean predialysis blood pressure was roughly the same regardless of carvedilol treatment (144 mm Hg vs. 146 mm Hg). The frequency of intradialytic hypertension declined from 77% of hemodialysis sessions at baseline to 28% by the study’s end, a significant difference.

Treatment with carvedilol showed a trend toward improvement of brachial artery flow–mediated dilation. However there was no change in C-reactive protein or pulse-wave velocity.

"With regard to safety, patients tolerated carvedilol fairly well," said Dr. Inrig. There was a low incidence of side effects.

Dr. Inrig reported that she has received an investigator-initiated research grant from Genzyme. She has also participated in industry-sponsored research for Keryx Biopharmaceuticals.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

"Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up," Dr. Kurt Kennel said at the annual meeting of the Endocrine Society.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

The findings are particularly important given the increasing number of severely obese individuals who are turning to bariatric surgery as a treatment option.

"We have questions about what this means in the long term," said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1-2 years and the only issues addressed are related to surgery or weight.

"Some issues – like bone, for example – may not show the manifestations of these effects for many years, and therefore we may be missing some of those effects," said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. The REP Project connects medical records from the Mayo Clinic, local hospitals, and local private practices.

The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic. Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures. Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study. Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks. For now though, it’s unclear what is driving the fracture increase in these patients.

The increased rate of fractures following bariatric surgery "suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important. Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery."

Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

"Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up," Dr. Kurt Kennel said at the annual meeting of the Endocrine Society.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

The findings are particularly important given the increasing number of severely obese individuals who are turning to bariatric surgery as a treatment option.

"We have questions about what this means in the long term," said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1-2 years and the only issues addressed are related to surgery or weight.

"Some issues – like bone, for example – may not show the manifestations of these effects for many years, and therefore we may be missing some of those effects," said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. The REP Project connects medical records from the Mayo Clinic, local hospitals, and local private practices.

The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic. Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures. Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study. Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks. For now though, it’s unclear what is driving the fracture increase in these patients.

The increased rate of fractures following bariatric surgery "suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important. Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery."

Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

"Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up," Dr. Kurt Kennel said at the annual meeting of the Endocrine Society.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

The findings are particularly important given the increasing number of severely obese individuals who are turning to bariatric surgery as a treatment option.

"We have questions about what this means in the long term," said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1-2 years and the only issues addressed are related to surgery or weight.

"Some issues – like bone, for example – may not show the manifestations of these effects for many years, and therefore we may be missing some of those effects," said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. The REP Project connects medical records from the Mayo Clinic, local hospitals, and local private practices.

The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic. Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures. Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study. Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks. For now though, it’s unclear what is driving the fracture increase in these patients.

The increased rate of fractures following bariatric surgery "suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important. Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery."

Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Use of the type 2 medication, liraglutide, helped control glycemic oscillations in type 1 diabetes, significantly lowered hemoglobin A_1c levels, and was associated with weight loss, a small study has shown.

The net effect is not only an improvement in mean fasting and weekly glucose concentrations, but also "you have a remarkable effect on the oscillations of glucose," seen among type 1 diabetic patients, Dr. Paresh Dandona said during a press conference at the annual meeting of the Endocrine Society.

Liraglutide (Vitoza), made by Novo Nordisk, is a glucagonlike peptide-1 (GLP-1) receptor agonist that is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As a GLP-1 analogue, liraglutide stimulates the release of insulin in response to elevated levels of blood sugar. It also inhibits the release of glucagon following meals, slowing the rate of food absorption from the gut into the bloodstream.

At the meeting, Dr. Ajay Varanasi reported the results of a prospective study in which 14 patients (9 male) with type 1 diabetes all used liraglutide. Treatment for six of the patients involved a 1-week pretreatment period to optimize glycemic control, 1 week of liraglutide therapy, and 1 week post treatment. Eight additional patients also had a 1-week pretreatment period, followed by 22 weeks of liraglutide therapy and 1 week post treatment, for a total of 24 weeks.

During treatment, patients were instructed to inject 0.6 mg of liraglutide subcutaneously every day. At the onset of treatment, patients were advised to reduce their basal insulin by a quarter and bolus by a third. "This was to avoid hypoglycemia," explained Dr. Varanasi, the lead author, who is with the division of endocrinology and metabolism at the State University of New York at Buffalo.

The eight patients treated for 24 weeks were advised to increase the daily dose of liraglutide to 1.2 mg after the first week and again to 1.8 mg after 2 weeks.

At baseline, the mean patient age was 40 years and the mean BMI was 24 kg/m². Patients had type 1 diabetes for an average of 24 years. The mean basal insulin was 24.5 U, the mean bolus was 22.5 U/day, and the mean HbA_1c level was 6.6%. All but one of the patients used insulin pumps, and the remaining patient was on four or more insulin injections per day. All patients used continuous glucose monitoring.

During the first week of treatment, despite the reduction in insulin, there was a significant reduction in mean fasting glucose and mean weekly blood glucose.

Most interestingly, said Dr. Varanasi, the mean weekly standard deviations in insulin concentrations were significantly reduced with treatment.

"Even in a reasonably well-controlled [type 1] diabetic with an HbA_1c of around 7% or less, there is [usually] a massive vacillation in insulin concentrations," observed Dr. Dandona, the principal investigator, who is chief of the division of endocrinology at the State University of New York at Buffalo.

The eight patients on longer-term therapy lost a significant amount of weight – down from a mean of 68 kg to 63.5 kg. The mean HbA_1c level dropped from 6.5% to 6.1%, which also was significant. Mean basal insulin dropped by 48%, and mean bolus dropped by 42%.

The decrease in mean blood glucose was significantly reduced within the 24-48 hours. "This tells us that the response is pretty quick. And the mean standard deviation values were reduced within 48 hours," Dr. Varanasi noted.

The mechanism of action is unknown. However, Dr. Varanasi hypothesized that liraglutide might decrease the concentration of glucagon secreted after meals. Another theory is that the decrease in postprandial glucose excursion might be the result of slower gastric emptying, which is known to occur with liraglutide. The weight loss seen in patients on liraglutide may have also contributed to improved glycemic control.

Two of the authors have significant financial relationships with several pharmaceutical companies, but not Novo Nordisk. The remaining authors, including Dr. Varanasi, reported that they have no relevant financial disclosures.

BOSTON – Use of the type 2 medication, liraglutide, helped control glycemic oscillations in type 1 diabetes, significantly lowered hemoglobin A_1c levels, and was associated with weight loss, a small study has shown.

The net effect is not only an improvement in mean fasting and weekly glucose concentrations, but also "you have a remarkable effect on the oscillations of glucose," seen among type 1 diabetic patients, Dr. Paresh Dandona said during a press conference at the annual meeting of the Endocrine Society.

Liraglutide (Vitoza), made by Novo Nordisk, is a glucagonlike peptide-1 (GLP-1) receptor agonist that is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As a GLP-1 analogue, liraglutide stimulates the release of insulin in response to elevated levels of blood sugar. It also inhibits the release of glucagon following meals, slowing the rate of food absorption from the gut into the bloodstream.

At the meeting, Dr. Ajay Varanasi reported the results of a prospective study in which 14 patients (9 male) with type 1 diabetes all used liraglutide. Treatment for six of the patients involved a 1-week pretreatment period to optimize glycemic control, 1 week of liraglutide therapy, and 1 week post treatment. Eight additional patients also had a 1-week pretreatment period, followed by 22 weeks of liraglutide therapy and 1 week post treatment, for a total of 24 weeks.

During treatment, patients were instructed to inject 0.6 mg of liraglutide subcutaneously every day. At the onset of treatment, patients were advised to reduce their basal insulin by a quarter and bolus by a third. "This was to avoid hypoglycemia," explained Dr. Varanasi, the lead author, who is with the division of endocrinology and metabolism at the State University of New York at Buffalo.

The eight patients treated for 24 weeks were advised to increase the daily dose of liraglutide to 1.2 mg after the first week and again to 1.8 mg after 2 weeks.

At baseline, the mean patient age was 40 years and the mean BMI was 24 kg/m². Patients had type 1 diabetes for an average of 24 years. The mean basal insulin was 24.5 U, the mean bolus was 22.5 U/day, and the mean HbA_1c level was 6.6%. All but one of the patients used insulin pumps, and the remaining patient was on four or more insulin injections per day. All patients used continuous glucose monitoring.

During the first week of treatment, despite the reduction in insulin, there was a significant reduction in mean fasting glucose and mean weekly blood glucose.

Most interestingly, said Dr. Varanasi, the mean weekly standard deviations in insulin concentrations were significantly reduced with treatment.

"Even in a reasonably well-controlled [type 1] diabetic with an HbA_1c of around 7% or less, there is [usually] a massive vacillation in insulin concentrations," observed Dr. Dandona, the principal investigator, who is chief of the division of endocrinology at the State University of New York at Buffalo.

The eight patients on longer-term therapy lost a significant amount of weight – down from a mean of 68 kg to 63.5 kg. The mean HbA_1c level dropped from 6.5% to 6.1%, which also was significant. Mean basal insulin dropped by 48%, and mean bolus dropped by 42%.

The decrease in mean blood glucose was significantly reduced within the 24-48 hours. "This tells us that the response is pretty quick. And the mean standard deviation values were reduced within 48 hours," Dr. Varanasi noted.

The mechanism of action is unknown. However, Dr. Varanasi hypothesized that liraglutide might decrease the concentration of glucagon secreted after meals. Another theory is that the decrease in postprandial glucose excursion might be the result of slower gastric emptying, which is known to occur with liraglutide. The weight loss seen in patients on liraglutide may have also contributed to improved glycemic control.

Two of the authors have significant financial relationships with several pharmaceutical companies, but not Novo Nordisk. The remaining authors, including Dr. Varanasi, reported that they have no relevant financial disclosures.

BOSTON – Use of the type 2 medication, liraglutide, helped control glycemic oscillations in type 1 diabetes, significantly lowered hemoglobin A_1c levels, and was associated with weight loss, a small study has shown.

The net effect is not only an improvement in mean fasting and weekly glucose concentrations, but also "you have a remarkable effect on the oscillations of glucose," seen among type 1 diabetic patients, Dr. Paresh Dandona said during a press conference at the annual meeting of the Endocrine Society.

Liraglutide (Vitoza), made by Novo Nordisk, is a glucagonlike peptide-1 (GLP-1) receptor agonist that is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As a GLP-1 analogue, liraglutide stimulates the release of insulin in response to elevated levels of blood sugar. It also inhibits the release of glucagon following meals, slowing the rate of food absorption from the gut into the bloodstream.

At the meeting, Dr. Ajay Varanasi reported the results of a prospective study in which 14 patients (9 male) with type 1 diabetes all used liraglutide. Treatment for six of the patients involved a 1-week pretreatment period to optimize glycemic control, 1 week of liraglutide therapy, and 1 week post treatment. Eight additional patients also had a 1-week pretreatment period, followed by 22 weeks of liraglutide therapy and 1 week post treatment, for a total of 24 weeks.

During treatment, patients were instructed to inject 0.6 mg of liraglutide subcutaneously every day. At the onset of treatment, patients were advised to reduce their basal insulin by a quarter and bolus by a third. "This was to avoid hypoglycemia," explained Dr. Varanasi, the lead author, who is with the division of endocrinology and metabolism at the State University of New York at Buffalo.

The eight patients treated for 24 weeks were advised to increase the daily dose of liraglutide to 1.2 mg after the first week and again to 1.8 mg after 2 weeks.

At baseline, the mean patient age was 40 years and the mean BMI was 24 kg/m². Patients had type 1 diabetes for an average of 24 years. The mean basal insulin was 24.5 U, the mean bolus was 22.5 U/day, and the mean HbA_1c level was 6.6%. All but one of the patients used insulin pumps, and the remaining patient was on four or more insulin injections per day. All patients used continuous glucose monitoring.

During the first week of treatment, despite the reduction in insulin, there was a significant reduction in mean fasting glucose and mean weekly blood glucose.

Most interestingly, said Dr. Varanasi, the mean weekly standard deviations in insulin concentrations were significantly reduced with treatment.

"Even in a reasonably well-controlled [type 1] diabetic with an HbA_1c of around 7% or less, there is [usually] a massive vacillation in insulin concentrations," observed Dr. Dandona, the principal investigator, who is chief of the division of endocrinology at the State University of New York at Buffalo.

The eight patients on longer-term therapy lost a significant amount of weight – down from a mean of 68 kg to 63.5 kg. The mean HbA_1c level dropped from 6.5% to 6.1%, which also was significant. Mean basal insulin dropped by 48%, and mean bolus dropped by 42%.

The decrease in mean blood glucose was significantly reduced within the 24-48 hours. "This tells us that the response is pretty quick. And the mean standard deviation values were reduced within 48 hours," Dr. Varanasi noted.

The mechanism of action is unknown. However, Dr. Varanasi hypothesized that liraglutide might decrease the concentration of glucagon secreted after meals. Another theory is that the decrease in postprandial glucose excursion might be the result of slower gastric emptying, which is known to occur with liraglutide. The weight loss seen in patients on liraglutide may have also contributed to improved glycemic control.

Two of the authors have significant financial relationships with several pharmaceutical companies, but not Novo Nordisk. The remaining authors, including Dr. Varanasi, reported that they have no relevant financial disclosures.

BOSTON – Use of the type 2 medication, liraglutide, helped control glycemic oscillations in type 1 diabetes, significantly lowered hemoglobin A_1c levels, and was associated with weight loss, a small study has shown.

The net effect is not only an improvement in mean fasting and weekly glucose concentrations, but also "you have a remarkable effect on the oscillations of glucose," seen among type 1 diabetic patients, Dr. Paresh Dandona said during a press conference at the annual meeting of the Endocrine Society.

Liraglutide (Vitoza), made by Novo Nordisk, is a glucagonlike peptide-1 (GLP-1) receptor agonist that is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As a GLP-1 analogue, liraglutide stimulates the release of insulin in response to elevated levels of blood sugar. It also inhibits the release of glucagon following meals, slowing the rate of food absorption from the gut into the bloodstream.

At the meeting, Dr. Ajay Varanasi reported the results of a prospective study in which 14 patients (9 male) with type 1 diabetes all used liraglutide. Treatment for six of the patients involved a 1-week pretreatment period to optimize glycemic control, 1 week of liraglutide therapy, and 1 week post treatment. Eight additional patients also had a 1-week pretreatment period, followed by 22 weeks of liraglutide therapy and 1 week post treatment, for a total of 24 weeks.

During treatment, patients were instructed to inject 0.6 mg of liraglutide subcutaneously every day. At the onset of treatment, patients were advised to reduce their basal insulin by a quarter and bolus by a third. "This was to avoid hypoglycemia," explained Dr. Varanasi, the lead author, who is with the division of endocrinology and metabolism at the State University of New York at Buffalo.

The eight patients treated for 24 weeks were advised to increase the daily dose of liraglutide to 1.2 mg after the first week and again to 1.8 mg after 2 weeks.

At baseline, the mean patient age was 40 years and the mean BMI was 24 kg/m². Patients had type 1 diabetes for an average of 24 years. The mean basal insulin was 24.5 U, the mean bolus was 22.5 U/day, and the mean HbA_1c level was 6.6%. All but one of the patients used insulin pumps, and the remaining patient was on four or more insulin injections per day. All patients used continuous glucose monitoring.

During the first week of treatment, despite the reduction in insulin, there was a significant reduction in mean fasting glucose and mean weekly blood glucose.

Most interestingly, said Dr. Varanasi, the mean weekly standard deviations in insulin concentrations were significantly reduced with treatment.

"Even in a reasonably well-controlled [type 1] diabetic with an HbA_1c of around 7% or less, there is [usually] a massive vacillation in insulin concentrations," observed Dr. Dandona, the principal investigator, who is chief of the division of endocrinology at the State University of New York at Buffalo.

The eight patients on longer-term therapy lost a significant amount of weight – down from a mean of 68 kg to 63.5 kg. The mean HbA_1c level dropped from 6.5% to 6.1%, which also was significant. Mean basal insulin dropped by 48%, and mean bolus dropped by 42%.

The decrease in mean blood glucose was significantly reduced within the 24-48 hours. "This tells us that the response is pretty quick. And the mean standard deviation values were reduced within 48 hours," Dr. Varanasi noted.

The mechanism of action is unknown. However, Dr. Varanasi hypothesized that liraglutide might decrease the concentration of glucagon secreted after meals. Another theory is that the decrease in postprandial glucose excursion might be the result of slower gastric emptying, which is known to occur with liraglutide. The weight loss seen in patients on liraglutide may have also contributed to improved glycemic control.

Two of the authors have significant financial relationships with several pharmaceutical companies, but not Novo Nordisk. The remaining authors, including Dr. Varanasi, reported that they have no relevant financial disclosures.

BOSTON – Use of the type 2 medication, liraglutide, helped control glycemic oscillations in type 1 diabetes, significantly lowered hemoglobin A_1c levels, and was associated with weight loss, a small study has shown.

The net effect is not only an improvement in mean fasting and weekly glucose concentrations, but also "you have a remarkable effect on the oscillations of glucose," seen among type 1 diabetic patients, Dr. Paresh Dandona said during a press conference at the annual meeting of the Endocrine Society.

Liraglutide (Vitoza), made by Novo Nordisk, is a glucagonlike peptide-1 (GLP-1) receptor agonist that is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As a GLP-1 analogue, liraglutide stimulates the release of insulin in response to elevated levels of blood sugar. It also inhibits the release of glucagon following meals, slowing the rate of food absorption from the gut into the bloodstream.

At the meeting, Dr. Ajay Varanasi reported the results of a prospective study in which 14 patients (9 male) with type 1 diabetes all used liraglutide. Treatment for six of the patients involved a 1-week pretreatment period to optimize glycemic control, 1 week of liraglutide therapy, and 1 week post treatment. Eight additional patients also had a 1-week pretreatment period, followed by 22 weeks of liraglutide therapy and 1 week post treatment, for a total of 24 weeks.

During treatment, patients were instructed to inject 0.6 mg of liraglutide subcutaneously every day. At the onset of treatment, patients were advised to reduce their basal insulin by a quarter and bolus by a third. "This was to avoid hypoglycemia," explained Dr. Varanasi, the lead author, who is with the division of endocrinology and metabolism at the State University of New York at Buffalo.

The eight patients treated for 24 weeks were advised to increase the daily dose of liraglutide to 1.2 mg after the first week and again to 1.8 mg after 2 weeks.

At baseline, the mean patient age was 40 years and the mean BMI was 24 kg/m². Patients had type 1 diabetes for an average of 24 years. The mean basal insulin was 24.5 U, the mean bolus was 22.5 U/day, and the mean HbA_1c level was 6.6%. All but one of the patients used insulin pumps, and the remaining patient was on four or more insulin injections per day. All patients used continuous glucose monitoring.

During the first week of treatment, despite the reduction in insulin, there was a significant reduction in mean fasting glucose and mean weekly blood glucose.

Most interestingly, said Dr. Varanasi, the mean weekly standard deviations in insulin concentrations were significantly reduced with treatment.

"Even in a reasonably well-controlled [type 1] diabetic with an HbA_1c of around 7% or less, there is [usually] a massive vacillation in insulin concentrations," observed Dr. Dandona, the principal investigator, who is chief of the division of endocrinology at the State University of New York at Buffalo.

The eight patients on longer-term therapy lost a significant amount of weight – down from a mean of 68 kg to 63.5 kg. The mean HbA_1c level dropped from 6.5% to 6.1%, which also was significant. Mean basal insulin dropped by 48%, and mean bolus dropped by 42%.

The decrease in mean blood glucose was significantly reduced within the 24-48 hours. "This tells us that the response is pretty quick. And the mean standard deviation values were reduced within 48 hours," Dr. Varanasi noted.

The mechanism of action is unknown. However, Dr. Varanasi hypothesized that liraglutide might decrease the concentration of glucagon secreted after meals. Another theory is that the decrease in postprandial glucose excursion might be the result of slower gastric emptying, which is known to occur with liraglutide. The weight loss seen in patients on liraglutide may have also contributed to improved glycemic control.

Two of the authors have significant financial relationships with several pharmaceutical companies, but not Novo Nordisk. The remaining authors, including Dr. Varanasi, reported that they have no relevant financial disclosures.

BOSTON – Use of the type 2 medication, liraglutide, helped control glycemic oscillations in type 1 diabetes, significantly lowered hemoglobin A_1c levels, and was associated with weight loss, a small study has shown.

The net effect is not only an improvement in mean fasting and weekly glucose concentrations, but also "you have a remarkable effect on the oscillations of glucose," seen among type 1 diabetic patients, Dr. Paresh Dandona said during a press conference at the annual meeting of the Endocrine Society.

Liraglutide (Vitoza), made by Novo Nordisk, is a glucagonlike peptide-1 (GLP-1) receptor agonist that is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As a GLP-1 analogue, liraglutide stimulates the release of insulin in response to elevated levels of blood sugar. It also inhibits the release of glucagon following meals, slowing the rate of food absorption from the gut into the bloodstream.

At the meeting, Dr. Ajay Varanasi reported the results of a prospective study in which 14 patients (9 male) with type 1 diabetes all used liraglutide. Treatment for six of the patients involved a 1-week pretreatment period to optimize glycemic control, 1 week of liraglutide therapy, and 1 week post treatment. Eight additional patients also had a 1-week pretreatment period, followed by 22 weeks of liraglutide therapy and 1 week post treatment, for a total of 24 weeks.

During treatment, patients were instructed to inject 0.6 mg of liraglutide subcutaneously every day. At the onset of treatment, patients were advised to reduce their basal insulin by a quarter and bolus by a third. "This was to avoid hypoglycemia," explained Dr. Varanasi, the lead author, who is with the division of endocrinology and metabolism at the State University of New York at Buffalo.

The eight patients treated for 24 weeks were advised to increase the daily dose of liraglutide to 1.2 mg after the first week and again to 1.8 mg after 2 weeks.

At baseline, the mean patient age was 40 years and the mean BMI was 24 kg/m². Patients had type 1 diabetes for an average of 24 years. The mean basal insulin was 24.5 U, the mean bolus was 22.5 U/day, and the mean HbA_1c level was 6.6%. All but one of the patients used insulin pumps, and the remaining patient was on four or more insulin injections per day. All patients used continuous glucose monitoring.

During the first week of treatment, despite the reduction in insulin, there was a significant reduction in mean fasting glucose and mean weekly blood glucose.

Most interestingly, said Dr. Varanasi, the mean weekly standard deviations in insulin concentrations were significantly reduced with treatment.

"Even in a reasonably well-controlled [type 1] diabetic with an HbA_1c of around 7% or less, there is [usually] a massive vacillation in insulin concentrations," observed Dr. Dandona, the principal investigator, who is chief of the division of endocrinology at the State University of New York at Buffalo.

The eight patients on longer-term therapy lost a significant amount of weight – down from a mean of 68 kg to 63.5 kg. The mean HbA_1c level dropped from 6.5% to 6.1%, which also was significant. Mean basal insulin dropped by 48%, and mean bolus dropped by 42%.

The decrease in mean blood glucose was significantly reduced within the 24-48 hours. "This tells us that the response is pretty quick. And the mean standard deviation values were reduced within 48 hours," Dr. Varanasi noted.

The mechanism of action is unknown. However, Dr. Varanasi hypothesized that liraglutide might decrease the concentration of glucagon secreted after meals. Another theory is that the decrease in postprandial glucose excursion might be the result of slower gastric emptying, which is known to occur with liraglutide. The weight loss seen in patients on liraglutide may have also contributed to improved glycemic control.

Two of the authors have significant financial relationships with several pharmaceutical companies, but not Novo Nordisk. The remaining authors, including Dr. Varanasi, reported that they have no relevant financial disclosures.

Early data indicate that gastric plication could become another surgical option to help very obese individuals shed excess weight, but head-to-head randomized trials comparing the new approach with other bariatric procedures, such as sleeve gastrectomy and adjustable gastric banding, are still needed.

"If it turns out to be something that is safe and effective in the long term, I would hope that it would fill a gap in the risk-benefit spectrum of what we can offer. I don’t anticipate that it would replace anything that we’re currently doing. It’s something else that we can offer patients that might appeal to more patients," Dr. Stacy A. Brethauer said in an interview.

In a recent study with 15 patients, Dr. Brethauer and his coinvestigators demonstrated that plication of the anterior stomach or greater curvature – particularly the latter – can lead to early and significant weight loss in morbidly obese individuals (Surg. Obes. Relat. Dis. 2011;7:15-22).

At 1 year following the procedure, those in the anterior plication (AP) and greater curvature plication (GCP) groups had excess weight losses of 23.3% and 53.4%, respectively. The difference in weight loss for the two groups was marginally statistically significant (P = .0649).

Both techniques involve folding the stomach in on itself and suturing the fold in place, creating a smaller stomach space. "The idea is that rather than removing part of the stomach, as we do with sleeve gastrectomy, we are folding the stomach inward to create a narrow tubular stomach," said Dr. Brethauer, a surgeon at the Cleveland Clinic Bariatric and Metabolic Institute.

In this study, "the anterior gastric wall was folded inward from the fundus to the antrum using at least two rows of 2-0 polypropylene running suture. The greater and lesser curvatures were approximated on the anterior surface of the stomach to create an intraluminal fold," the investigators wrote.

For GCP, "the short gastric vessels were divided starting 4 cm from the pylorus and continuing up to the left crus of the diaphragm, similar to the dissection performed for sleeve gastrectomy. After the fundus and body were completely mobilized, the greater curvature was imbricated with at least 2 suture lines of 2-0 polypropylene suture to create a large intraluminal gastric fold. The fold was started just below the angle of His and continued distally to within 4 cm of the pylorus," they wrote.

"We tried the anterior plication first because it seemed less risky, as we didn’t have to mobilize the entire greater curvature of the stomach. ... [It] was the least invasive way to try the technique initially, but we did not see good weight-loss results. So we moved to the greater curvature technique to try to get more of the stomach folded in," Dr. Brethauer said.

"With the anterior plication, you can really make the anterior wall of the stomach very tight but you still have all the posterior stomach volume that is unchanged. I think that’s probably why the patients didn’t do as well. They still had a lot of capacity posteriorly that we weren’t addressing." For this reason, the investigators are not pursuing AP in further clinical studies. GCP "more closely mimics the sleeve gastrectomy in terms of how much volume reduction you get in the stomach," he explained.

GCP is performed laparoscopically, which offers fast recovery and less pain. Theoretically, the procedure is reversible. "We’ve not reversed any in humans. But unlike the sleeve, where you’re actually removing something, this is something that could be reversible – I like to use the term revisable," said Dr. Brethauer. "If we needed to do something else down the road, we could restore the normal anatomy and convert the patient to another weight-loss procedure."

From a patient’s perspective, "reversibility is an important factor. I think that has kept some patients away from pursuing the sleeve gastrectomy or the gastric bypass. The sleeve, of course, is irreversible and the bypass is difficult to reverse and is perceived by patients as irreversible."

It’s too early to know the true costs, but gastric plication appears to be less expensive than sleeve gastrectomy. "It can be a relatively low-cost operation because you’re not using any staplers and you’re not placing any devices," said Dr. Brethauer, adding that it’s becoming popular in certain countries outside the United States.

Although the procedure is fairly straightforward, there is a learning curve. Dr. Brethauer noted a couple of lessons learned: A fold that is too tight can cause severe dysphagia or an obstruction of the gastric lumen, whereas a fold that is too loose, leaving a large gastric volume, would likely lead to a high rate of weight regain in the long term.

Gastric plication is a restrictive operation. "In our experience so far with the 50-plus patients that we’ve done, their satiety is very good. Patients are achieving rapid weight loss and are very satisfied with their early outcomes. Our clinical experience with this procedure so far has been promising," he said.

It’s unknown what, if any, nutritional consequences may be associated with the procedure. "Even with sleeve gastrectomy, we don’t have a lot of very good data on the long-term nutritional consequences of the sleeve. Presumably, there will be some micronutrient deficiencies with gastric plication because the overall dietary intake is lower," Dr. Brethauer noted.

"We’re treating this – from a nutritional standpoint – similarly to what we do with the sleeve ... multivitamins with iron and extra supplementation as needed, based on our follow-up labs. ... There’s no good data to say what effect this has on micronutrients at this point, so we’re being conservative in our approach."

Nausea, a common side effect, typically resolves within several days after surgery, according to Dr. Brethauer.

Because gastric plication is an investigational procedure, patients currently must pay for it out of pocket. Patients increasingly are interested in this approach, but much more data with favorable long-term outcomes will be needed before insurers will agree to cover it, according to Dr. Brethauer.

Thus far, most patients who have undergone this investigational procedure have had a body mass index of 35-50 kg/m². "We’re trying not to go to the very high BMIs at this point until we have more experience," Dr. Brethauer said.

GCP is not yet an outpatient procedure. "We’ve kept patients for 1 or 2 nights in the hospital just because we are still learning about the procedure. But I think that as we get more experience with it, carefully selected patients may be able to go home [on] the same day as the operation."

The study was funded by Ethicon Endo-Surgery, and the sponsor paid for all the preoperative testing and consultations, surgery, treatment of any potential complications, as well as all the follow-up testing and visits after surgery during the study period. Dr. Brethauer is a consultant, speaker, and advisory board member for Ethicon Endo-Surgery, a speaker for Covidien, and a consultant for Apollo Endosurgery.

Early data indicate that gastric plication could become another surgical option to help very obese individuals shed excess weight, but head-to-head randomized trials comparing the new approach with other bariatric procedures, such as sleeve gastrectomy and adjustable gastric banding, are still needed.

"If it turns out to be something that is safe and effective in the long term, I would hope that it would fill a gap in the risk-benefit spectrum of what we can offer. I don’t anticipate that it would replace anything that we’re currently doing. It’s something else that we can offer patients that might appeal to more patients," Dr. Stacy A. Brethauer said in an interview.

In a recent study with 15 patients, Dr. Brethauer and his coinvestigators demonstrated that plication of the anterior stomach or greater curvature – particularly the latter – can lead to early and significant weight loss in morbidly obese individuals (Surg. Obes. Relat. Dis. 2011;7:15-22).

At 1 year following the procedure, those in the anterior plication (AP) and greater curvature plication (GCP) groups had excess weight losses of 23.3% and 53.4%, respectively. The difference in weight loss for the two groups was marginally statistically significant (P = .0649).

Both techniques involve folding the stomach in on itself and suturing the fold in place, creating a smaller stomach space. "The idea is that rather than removing part of the stomach, as we do with sleeve gastrectomy, we are folding the stomach inward to create a narrow tubular stomach," said Dr. Brethauer, a surgeon at the Cleveland Clinic Bariatric and Metabolic Institute.

In this study, "the anterior gastric wall was folded inward from the fundus to the antrum using at least two rows of 2-0 polypropylene running suture. The greater and lesser curvatures were approximated on the anterior surface of the stomach to create an intraluminal fold," the investigators wrote.

For GCP, "the short gastric vessels were divided starting 4 cm from the pylorus and continuing up to the left crus of the diaphragm, similar to the dissection performed for sleeve gastrectomy. After the fundus and body were completely mobilized, the greater curvature was imbricated with at least 2 suture lines of 2-0 polypropylene suture to create a large intraluminal gastric fold. The fold was started just below the angle of His and continued distally to within 4 cm of the pylorus," they wrote.

"We tried the anterior plication first because it seemed less risky, as we didn’t have to mobilize the entire greater curvature of the stomach. ... [It] was the least invasive way to try the technique initially, but we did not see good weight-loss results. So we moved to the greater curvature technique to try to get more of the stomach folded in," Dr. Brethauer said.

"With the anterior plication, you can really make the anterior wall of the stomach very tight but you still have all the posterior stomach volume that is unchanged. I think that’s probably why the patients didn’t do as well. They still had a lot of capacity posteriorly that we weren’t addressing." For this reason, the investigators are not pursuing AP in further clinical studies. GCP "more closely mimics the sleeve gastrectomy in terms of how much volume reduction you get in the stomach," he explained.

GCP is performed laparoscopically, which offers fast recovery and less pain. Theoretically, the procedure is reversible. "We’ve not reversed any in humans. But unlike the sleeve, where you’re actually removing something, this is something that could be reversible – I like to use the term revisable," said Dr. Brethauer. "If we needed to do something else down the road, we could restore the normal anatomy and convert the patient to another weight-loss procedure."

From a patient’s perspective, "reversibility is an important factor. I think that has kept some patients away from pursuing the sleeve gastrectomy or the gastric bypass. The sleeve, of course, is irreversible and the bypass is difficult to reverse and is perceived by patients as irreversible."

It’s too early to know the true costs, but gastric plication appears to be less expensive than sleeve gastrectomy. "It can be a relatively low-cost operation because you’re not using any staplers and you’re not placing any devices," said Dr. Brethauer, adding that it’s becoming popular in certain countries outside the United States.

Although the procedure is fairly straightforward, there is a learning curve. Dr. Brethauer noted a couple of lessons learned: A fold that is too tight can cause severe dysphagia or an obstruction of the gastric lumen, whereas a fold that is too loose, leaving a large gastric volume, would likely lead to a high rate of weight regain in the long term.

Gastric plication is a restrictive operation. "In our experience so far with the 50-plus patients that we’ve done, their satiety is very good. Patients are achieving rapid weight loss and are very satisfied with their early outcomes. Our clinical experience with this procedure so far has been promising," he said.

It’s unknown what, if any, nutritional consequences may be associated with the procedure. "Even with sleeve gastrectomy, we don’t have a lot of very good data on the long-term nutritional consequences of the sleeve. Presumably, there will be some micronutrient deficiencies with gastric plication because the overall dietary intake is lower," Dr. Brethauer noted.

"We’re treating this – from a nutritional standpoint – similarly to what we do with the sleeve ... multivitamins with iron and extra supplementation as needed, based on our follow-up labs. ... There’s no good data to say what effect this has on micronutrients at this point, so we’re being conservative in our approach."

Nausea, a common side effect, typically resolves within several days after surgery, according to Dr. Brethauer.

Because gastric plication is an investigational procedure, patients currently must pay for it out of pocket. Patients increasingly are interested in this approach, but much more data with favorable long-term outcomes will be needed before insurers will agree to cover it, according to Dr. Brethauer.

Thus far, most patients who have undergone this investigational procedure have had a body mass index of 35-50 kg/m². "We’re trying not to go to the very high BMIs at this point until we have more experience," Dr. Brethauer said.

GCP is not yet an outpatient procedure. "We’ve kept patients for 1 or 2 nights in the hospital just because we are still learning about the procedure. But I think that as we get more experience with it, carefully selected patients may be able to go home [on] the same day as the operation."

The study was funded by Ethicon Endo-Surgery, and the sponsor paid for all the preoperative testing and consultations, surgery, treatment of any potential complications, as well as all the follow-up testing and visits after surgery during the study period. Dr. Brethauer is a consultant, speaker, and advisory board member for Ethicon Endo-Surgery, a speaker for Covidien, and a consultant for Apollo Endosurgery.

Early data indicate that gastric plication could become another surgical option to help very obese individuals shed excess weight, but head-to-head randomized trials comparing the new approach with other bariatric procedures, such as sleeve gastrectomy and adjustable gastric banding, are still needed.

"If it turns out to be something that is safe and effective in the long term, I would hope that it would fill a gap in the risk-benefit spectrum of what we can offer. I don’t anticipate that it would replace anything that we’re currently doing. It’s something else that we can offer patients that might appeal to more patients," Dr. Stacy A. Brethauer said in an interview.

In a recent study with 15 patients, Dr. Brethauer and his coinvestigators demonstrated that plication of the anterior stomach or greater curvature – particularly the latter – can lead to early and significant weight loss in morbidly obese individuals (Surg. Obes. Relat. Dis. 2011;7:15-22).

At 1 year following the procedure, those in the anterior plication (AP) and greater curvature plication (GCP) groups had excess weight losses of 23.3% and 53.4%, respectively. The difference in weight loss for the two groups was marginally statistically significant (P = .0649).

Both techniques involve folding the stomach in on itself and suturing the fold in place, creating a smaller stomach space. "The idea is that rather than removing part of the stomach, as we do with sleeve gastrectomy, we are folding the stomach inward to create a narrow tubular stomach," said Dr. Brethauer, a surgeon at the Cleveland Clinic Bariatric and Metabolic Institute.

In this study, "the anterior gastric wall was folded inward from the fundus to the antrum using at least two rows of 2-0 polypropylene running suture. The greater and lesser curvatures were approximated on the anterior surface of the stomach to create an intraluminal fold," the investigators wrote.

For GCP, "the short gastric vessels were divided starting 4 cm from the pylorus and continuing up to the left crus of the diaphragm, similar to the dissection performed for sleeve gastrectomy. After the fundus and body were completely mobilized, the greater curvature was imbricated with at least 2 suture lines of 2-0 polypropylene suture to create a large intraluminal gastric fold. The fold was started just below the angle of His and continued distally to within 4 cm of the pylorus," they wrote.

"We tried the anterior plication first because it seemed less risky, as we didn’t have to mobilize the entire greater curvature of the stomach. ... [It] was the least invasive way to try the technique initially, but we did not see good weight-loss results. So we moved to the greater curvature technique to try to get more of the stomach folded in," Dr. Brethauer said.

"With the anterior plication, you can really make the anterior wall of the stomach very tight but you still have all the posterior stomach volume that is unchanged. I think that’s probably why the patients didn’t do as well. They still had a lot of capacity posteriorly that we weren’t addressing." For this reason, the investigators are not pursuing AP in further clinical studies. GCP "more closely mimics the sleeve gastrectomy in terms of how much volume reduction you get in the stomach," he explained.

GCP is performed laparoscopically, which offers fast recovery and less pain. Theoretically, the procedure is reversible. "We’ve not reversed any in humans. But unlike the sleeve, where you’re actually removing something, this is something that could be reversible – I like to use the term revisable," said Dr. Brethauer. "If we needed to do something else down the road, we could restore the normal anatomy and convert the patient to another weight-loss procedure."

From a patient’s perspective, "reversibility is an important factor. I think that has kept some patients away from pursuing the sleeve gastrectomy or the gastric bypass. The sleeve, of course, is irreversible and the bypass is difficult to reverse and is perceived by patients as irreversible."

It’s too early to know the true costs, but gastric plication appears to be less expensive than sleeve gastrectomy. "It can be a relatively low-cost operation because you’re not using any staplers and you’re not placing any devices," said Dr. Brethauer, adding that it’s becoming popular in certain countries outside the United States.

Although the procedure is fairly straightforward, there is a learning curve. Dr. Brethauer noted a couple of lessons learned: A fold that is too tight can cause severe dysphagia or an obstruction of the gastric lumen, whereas a fold that is too loose, leaving a large gastric volume, would likely lead to a high rate of weight regain in the long term.

Gastric plication is a restrictive operation. "In our experience so far with the 50-plus patients that we’ve done, their satiety is very good. Patients are achieving rapid weight loss and are very satisfied with their early outcomes. Our clinical experience with this procedure so far has been promising," he said.

It’s unknown what, if any, nutritional consequences may be associated with the procedure. "Even with sleeve gastrectomy, we don’t have a lot of very good data on the long-term nutritional consequences of the sleeve. Presumably, there will be some micronutrient deficiencies with gastric plication because the overall dietary intake is lower," Dr. Brethauer noted.

"We’re treating this – from a nutritional standpoint – similarly to what we do with the sleeve ... multivitamins with iron and extra supplementation as needed, based on our follow-up labs. ... There’s no good data to say what effect this has on micronutrients at this point, so we’re being conservative in our approach."

Nausea, a common side effect, typically resolves within several days after surgery, according to Dr. Brethauer.

Because gastric plication is an investigational procedure, patients currently must pay for it out of pocket. Patients increasingly are interested in this approach, but much more data with favorable long-term outcomes will be needed before insurers will agree to cover it, according to Dr. Brethauer.

Thus far, most patients who have undergone this investigational procedure have had a body mass index of 35-50 kg/m². "We’re trying not to go to the very high BMIs at this point until we have more experience," Dr. Brethauer said.

GCP is not yet an outpatient procedure. "We’ve kept patients for 1 or 2 nights in the hospital just because we are still learning about the procedure. But I think that as we get more experience with it, carefully selected patients may be able to go home [on] the same day as the operation."

The study was funded by Ethicon Endo-Surgery, and the sponsor paid for all the preoperative testing and consultations, surgery, treatment of any potential complications, as well as all the follow-up testing and visits after surgery during the study period. Dr. Brethauer is a consultant, speaker, and advisory board member for Ethicon Endo-Surgery, a speaker for Covidien, and a consultant for Apollo Endosurgery.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we're talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I'm very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we're talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I'm very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we're talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I'm very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

CHICAGO – By implementing an online risk assessment tool, researchers at one institution were able to improve hospital-wide prophylaxis and significantly cut the number of venous thrombotic events, Dr. Nicholas J. Morrissey said at the Vascular Annual Meeting.

"Our overall level of prophylaxis at both campuses was 98%; whereas preimplementation, we had about a 71% level of appropriate prophylaxis," said Dr. Morrissey of the department of surgery at Columbia University in New York.

Starting in June 2010, all patients admitted to New York–Presbyterian Hospital were required to have their venous thromboembolism (VTE) risk assessed as part of their electronic admission orders. Physicians were free to use a specially developed online risk assessment tool or their own judgment regarding prophylaxis.

The VTE risk assessment tool was created by a bicampus committee of clinicians from various specialties, IT support, nursing, and data management staff. This group also reviewed all documented VTE events from June 2010 to the present. Each event was subjected to clinical adjudication for accuracy.

Risk assessment and prophylaxis were monitored using AMALGA (Microsoft) software that allows real-time accumulation of clinical data that goes into the patient’s hospital electronic health record. VTE rates were monitored through chart review by certified coders and were double-checked for accuracy by reviewers with clinical backgrounds.

Patients who were positive for VTE events were further examined and rates were compared before and after implementation of the assessment tool. In addition, a random sampling of patients on several inpatient floors was performed to determine if the adequate level of VTE was being used.

"Through a very recent random sampling of 503 patients in the entire hospital, we looked to see what the adequate prophylaxis level was after the implementation of our tool," said Dr. Morrissey. This was defined as appropriate pharmacologic prophylaxis when indicated.

They also compared pre- and post-implementation periods to assess VTE rates. At New York–Presbyterian’s Columbia University Medical Center campus, the VTE rate prior to assessment implementation was 1.08/1,000 patient-days from January through June 2010. At the same campus, the VTE rate dropped to 0.80/1,000 patient-days from July through December. Similarly, at New York–Presbyterian’s other campus, Weill Cornell Medical Center, the VTE rate was 1.19/1,000 patient-days from January through June 2010; it dropped to 0.84/1,000 patient-days from July through December 2010.

"Interestingly, what we found at both institutions was that our pulmonary embolism rate dropped significantly between the first and second half of 2010," said Dr. Morrissey. At Columbia, the number of pulmonary embolisms dropped from 24 to 15. At Cornell, the number of PEs dropped from 41 to 15.

"We saw that a significant number of patients actually suffered from upper-extremity line-associated clots," he noted. At Columbia, there were 31 upper extremity events from January to June 2010; there were 33 from July to December. At Cornell, there were 38 upper extremity events in the first half of the year and 33 in the second half.

Both institutions used the AMALGA system to provide clinicians with feedback. The software calculates the patient’s risk score in real time as patients are admitted, based on their past medical history. The software also collects all of the information entered into the electronic order set. This allows staff to look and see which patients are listed as high risk or low risk and whether the clinician used the tool appropriately. "So we’re actually able to assess hospital wide how these patients are receiving prophylaxis," said Dr. Morrissey.

The tool also allows the identification of patients that are inappropriately classified based on risk and who are receiving inappropriate prophylaxis. "We can reach out to those clinicians in real time and discuss with them the issues related to prophylaxis."

With further validation, the system could prove a considerable asset in meeting and demonstrating quality goals, he noted.

The authors reported that they have no relevant disclosures.

CHICAGO – By implementing an online risk assessment tool, researchers at one institution were able to improve hospital-wide prophylaxis and significantly cut the number of venous thrombotic events, Dr. Nicholas J. Morrissey said at the Vascular Annual Meeting.

"Our overall level of prophylaxis at both campuses was 98%; whereas preimplementation, we had about a 71% level of appropriate prophylaxis," said Dr. Morrissey of the department of surgery at Columbia University in New York.

Starting in June 2010, all patients admitted to New York–Presbyterian Hospital were required to have their venous thromboembolism (VTE) risk assessed as part of their electronic admission orders. Physicians were free to use a specially developed online risk assessment tool or their own judgment regarding prophylaxis.

The VTE risk assessment tool was created by a bicampus committee of clinicians from various specialties, IT support, nursing, and data management staff. This group also reviewed all documented VTE events from June 2010 to the present. Each event was subjected to clinical adjudication for accuracy.

Risk assessment and prophylaxis were monitored using AMALGA (Microsoft) software that allows real-time accumulation of clinical data that goes into the patient’s hospital electronic health record. VTE rates were monitored through chart review by certified coders and were double-checked for accuracy by reviewers with clinical backgrounds.

Patients who were positive for VTE events were further examined and rates were compared before and after implementation of the assessment tool. In addition, a random sampling of patients on several inpatient floors was performed to determine if the adequate level of VTE was being used.

"Through a very recent random sampling of 503 patients in the entire hospital, we looked to see what the adequate prophylaxis level was after the implementation of our tool," said Dr. Morrissey. This was defined as appropriate pharmacologic prophylaxis when indicated.

They also compared pre- and post-implementation periods to assess VTE rates. At New York–Presbyterian’s Columbia University Medical Center campus, the VTE rate prior to assessment implementation was 1.08/1,000 patient-days from January through June 2010. At the same campus, the VTE rate dropped to 0.80/1,000 patient-days from July through December. Similarly, at New York–Presbyterian’s other campus, Weill Cornell Medical Center, the VTE rate was 1.19/1,000 patient-days from January through June 2010; it dropped to 0.84/1,000 patient-days from July through December 2010.

"Interestingly, what we found at both institutions was that our pulmonary embolism rate dropped significantly between the first and second half of 2010," said Dr. Morrissey. At Columbia, the number of pulmonary embolisms dropped from 24 to 15. At Cornell, the number of PEs dropped from 41 to 15.

"We saw that a significant number of patients actually suffered from upper-extremity line-associated clots," he noted. At Columbia, there were 31 upper extremity events from January to June 2010; there were 33 from July to December. At Cornell, there were 38 upper extremity events in the first half of the year and 33 in the second half.

Both institutions used the AMALGA system to provide clinicians with feedback. The software calculates the patient’s risk score in real time as patients are admitted, based on their past medical history. The software also collects all of the information entered into the electronic order set. This allows staff to look and see which patients are listed as high risk or low risk and whether the clinician used the tool appropriately. "So we’re actually able to assess hospital wide how these patients are receiving prophylaxis," said Dr. Morrissey.

The tool also allows the identification of patients that are inappropriately classified based on risk and who are receiving inappropriate prophylaxis. "We can reach out to those clinicians in real time and discuss with them the issues related to prophylaxis."

With further validation, the system could prove a considerable asset in meeting and demonstrating quality goals, he noted.

The authors reported that they have no relevant disclosures.

CHICAGO – By implementing an online risk assessment tool, researchers at one institution were able to improve hospital-wide prophylaxis and significantly cut the number of venous thrombotic events, Dr. Nicholas J. Morrissey said at the Vascular Annual Meeting.

"Our overall level of prophylaxis at both campuses was 98%; whereas preimplementation, we had about a 71% level of appropriate prophylaxis," said Dr. Morrissey of the department of surgery at Columbia University in New York.

Starting in June 2010, all patients admitted to New York–Presbyterian Hospital were required to have their venous thromboembolism (VTE) risk assessed as part of their electronic admission orders. Physicians were free to use a specially developed online risk assessment tool or their own judgment regarding prophylaxis.

The VTE risk assessment tool was created by a bicampus committee of clinicians from various specialties, IT support, nursing, and data management staff. This group also reviewed all documented VTE events from June 2010 to the present. Each event was subjected to clinical adjudication for accuracy.

Risk assessment and prophylaxis were monitored using AMALGA (Microsoft) software that allows real-time accumulation of clinical data that goes into the patient’s hospital electronic health record. VTE rates were monitored through chart review by certified coders and were double-checked for accuracy by reviewers with clinical backgrounds.

Patients who were positive for VTE events were further examined and rates were compared before and after implementation of the assessment tool. In addition, a random sampling of patients on several inpatient floors was performed to determine if the adequate level of VTE was being used.

"Through a very recent random sampling of 503 patients in the entire hospital, we looked to see what the adequate prophylaxis level was after the implementation of our tool," said Dr. Morrissey. This was defined as appropriate pharmacologic prophylaxis when indicated.

They also compared pre- and post-implementation periods to assess VTE rates. At New York–Presbyterian’s Columbia University Medical Center campus, the VTE rate prior to assessment implementation was 1.08/1,000 patient-days from January through June 2010. At the same campus, the VTE rate dropped to 0.80/1,000 patient-days from July through December. Similarly, at New York–Presbyterian’s other campus, Weill Cornell Medical Center, the VTE rate was 1.19/1,000 patient-days from January through June 2010; it dropped to 0.84/1,000 patient-days from July through December 2010.

"Interestingly, what we found at both institutions was that our pulmonary embolism rate dropped significantly between the first and second half of 2010," said Dr. Morrissey. At Columbia, the number of pulmonary embolisms dropped from 24 to 15. At Cornell, the number of PEs dropped from 41 to 15.

"We saw that a significant number of patients actually suffered from upper-extremity line-associated clots," he noted. At Columbia, there were 31 upper extremity events from January to June 2010; there were 33 from July to December. At Cornell, there were 38 upper extremity events in the first half of the year and 33 in the second half.

Both institutions used the AMALGA system to provide clinicians with feedback. The software calculates the patient’s risk score in real time as patients are admitted, based on their past medical history. The software also collects all of the information entered into the electronic order set. This allows staff to look and see which patients are listed as high risk or low risk and whether the clinician used the tool appropriately. "So we’re actually able to assess hospital wide how these patients are receiving prophylaxis," said Dr. Morrissey.

The tool also allows the identification of patients that are inappropriately classified based on risk and who are receiving inappropriate prophylaxis. "We can reach out to those clinicians in real time and discuss with them the issues related to prophylaxis."

With further validation, the system could prove a considerable asset in meeting and demonstrating quality goals, he noted.

The authors reported that they have no relevant disclosures.

CHICAGO – By implementing an online risk assessment tool, researchers at one institution were able to improve hospital-wide prophylaxis and significantly cut the number of venous thrombotic events, Dr. Nicholas J. Morrissey said at the Vascular Annual Meeting.

"Our overall level of prophylaxis at both campuses was 98%; whereas preimplementation, we had about a 71% level of appropriate prophylaxis," said Dr. Morrissey of the department of surgery at Columbia University in New York.

Starting in June 2010, all patients admitted to New York–Presbyterian Hospital were required to have their venous thromboembolism (VTE) risk assessed as part of their electronic admission orders. Physicians were free to use a specially developed online risk assessment tool or their own judgment regarding prophylaxis.

The VTE risk assessment tool was created by a bicampus committee of clinicians from various specialties, IT support, nursing, and data management staff. This group also reviewed all documented VTE events from June 2010 to the present. Each event was subjected to clinical adjudication for accuracy.

Risk assessment and prophylaxis were monitored using AMALGA (Microsoft) software that allows real-time accumulation of clinical data that goes into the patient’s hospital electronic health record. VTE rates were monitored through chart review by certified coders and were double-checked for accuracy by reviewers with clinical backgrounds.

Patients who were positive for VTE events were further examined and rates were compared before and after implementation of the assessment tool. In addition, a random sampling of patients on several inpatient floors was performed to determine if the adequate level of VTE was being used.

"Through a very recent random sampling of 503 patients in the entire hospital, we looked to see what the adequate prophylaxis level was after the implementation of our tool," said Dr. Morrissey. This was defined as appropriate pharmacologic prophylaxis when indicated.

They also compared pre- and post-implementation periods to assess VTE rates. At New York–Presbyterian’s Columbia University Medical Center campus, the VTE rate prior to assessment implementation was 1.08/1,000 patient-days from January through June 2010. At the same campus, the VTE rate dropped to 0.80/1,000 patient-days from July through December. Similarly, at New York–Presbyterian’s other campus, Weill Cornell Medical Center, the VTE rate was 1.19/1,000 patient-days from January through June 2010; it dropped to 0.84/1,000 patient-days from July through December 2010.

"Interestingly, what we found at both institutions was that our pulmonary embolism rate dropped significantly between the first and second half of 2010," said Dr. Morrissey. At Columbia, the number of pulmonary embolisms dropped from 24 to 15. At Cornell, the number of PEs dropped from 41 to 15.

"We saw that a significant number of patients actually suffered from upper-extremity line-associated clots," he noted. At Columbia, there were 31 upper extremity events from January to June 2010; there were 33 from July to December. At Cornell, there were 38 upper extremity events in the first half of the year and 33 in the second half.

Both institutions used the AMALGA system to provide clinicians with feedback. The software calculates the patient’s risk score in real time as patients are admitted, based on their past medical history. The software also collects all of the information entered into the electronic order set. This allows staff to look and see which patients are listed as high risk or low risk and whether the clinician used the tool appropriately. "So we’re actually able to assess hospital wide how these patients are receiving prophylaxis," said Dr. Morrissey.

The tool also allows the identification of patients that are inappropriately classified based on risk and who are receiving inappropriate prophylaxis. "We can reach out to those clinicians in real time and discuss with them the issues related to prophylaxis."

With further validation, the system could prove a considerable asset in meeting and demonstrating quality goals, he noted.

The authors reported that they have no relevant disclosures.

CHICAGO – By implementing an online risk assessment tool, researchers at one institution were able to improve hospital-wide prophylaxis and significantly cut the number of venous thrombotic events, Dr. Nicholas J. Morrissey said at the Vascular Annual Meeting.

"Our overall level of prophylaxis at both campuses was 98%; whereas preimplementation, we had about a 71% level of appropriate prophylaxis," said Dr. Morrissey of the department of surgery at Columbia University in New York.

Starting in June 2010, all patients admitted to New York–Presbyterian Hospital were required to have their venous thromboembolism (VTE) risk assessed as part of their electronic admission orders. Physicians were free to use a specially developed online risk assessment tool or their own judgment regarding prophylaxis.

The VTE risk assessment tool was created by a bicampus committee of clinicians from various specialties, IT support, nursing, and data management staff. This group also reviewed all documented VTE events from June 2010 to the present. Each event was subjected to clinical adjudication for accuracy.

Risk assessment and prophylaxis were monitored using AMALGA (Microsoft) software that allows real-time accumulation of clinical data that goes into the patient’s hospital electronic health record. VTE rates were monitored through chart review by certified coders and were double-checked for accuracy by reviewers with clinical backgrounds.

Patients who were positive for VTE events were further examined and rates were compared before and after implementation of the assessment tool. In addition, a random sampling of patients on several inpatient floors was performed to determine if the adequate level of VTE was being used.

"Through a very recent random sampling of 503 patients in the entire hospital, we looked to see what the adequate prophylaxis level was after the implementation of our tool," said Dr. Morrissey. This was defined as appropriate pharmacologic prophylaxis when indicated.

They also compared pre- and post-implementation periods to assess VTE rates. At New York–Presbyterian’s Columbia University Medical Center campus, the VTE rate prior to assessment implementation was 1.08/1,000 patient-days from January through June 2010. At the same campus, the VTE rate dropped to 0.80/1,000 patient-days from July through December. Similarly, at New York–Presbyterian’s other campus, Weill Cornell Medical Center, the VTE rate was 1.19/1,000 patient-days from January through June 2010; it dropped to 0.84/1,000 patient-days from July through December 2010.

"Interestingly, what we found at both institutions was that our pulmonary embolism rate dropped significantly between the first and second half of 2010," said Dr. Morrissey. At Columbia, the number of pulmonary embolisms dropped from 24 to 15. At Cornell, the number of PEs dropped from 41 to 15.

"We saw that a significant number of patients actually suffered from upper-extremity line-associated clots," he noted. At Columbia, there were 31 upper extremity events from January to June 2010; there were 33 from July to December. At Cornell, there were 38 upper extremity events in the first half of the year and 33 in the second half.

Both institutions used the AMALGA system to provide clinicians with feedback. The software calculates the patient’s risk score in real time as patients are admitted, based on their past medical history. The software also collects all of the information entered into the electronic order set. This allows staff to look and see which patients are listed as high risk or low risk and whether the clinician used the tool appropriately. "So we’re actually able to assess hospital wide how these patients are receiving prophylaxis," said Dr. Morrissey.

The tool also allows the identification of patients that are inappropriately classified based on risk and who are receiving inappropriate prophylaxis. "We can reach out to those clinicians in real time and discuss with them the issues related to prophylaxis."

With further validation, the system could prove a considerable asset in meeting and demonstrating quality goals, he noted.

The authors reported that they have no relevant disclosures.

CHICAGO – By implementing an online risk assessment tool, researchers at one institution were able to improve hospital-wide prophylaxis and significantly cut the number of venous thrombotic events, Dr. Nicholas J. Morrissey said at the Vascular Annual Meeting.

"Our overall level of prophylaxis at both campuses was 98%; whereas preimplementation, we had about a 71% level of appropriate prophylaxis," said Dr. Morrissey of the department of surgery at Columbia University in New York.

Starting in June 2010, all patients admitted to New York–Presbyterian Hospital were required to have their venous thromboembolism (VTE) risk assessed as part of their electronic admission orders. Physicians were free to use a specially developed online risk assessment tool or their own judgment regarding prophylaxis.

The VTE risk assessment tool was created by a bicampus committee of clinicians from various specialties, IT support, nursing, and data management staff. This group also reviewed all documented VTE events from June 2010 to the present. Each event was subjected to clinical adjudication for accuracy.

Risk assessment and prophylaxis were monitored using AMALGA (Microsoft) software that allows real-time accumulation of clinical data that goes into the patient’s hospital electronic health record. VTE rates were monitored through chart review by certified coders and were double-checked for accuracy by reviewers with clinical backgrounds.

Patients who were positive for VTE events were further examined and rates were compared before and after implementation of the assessment tool. In addition, a random sampling of patients on several inpatient floors was performed to determine if the adequate level of VTE was being used.

"Through a very recent random sampling of 503 patients in the entire hospital, we looked to see what the adequate prophylaxis level was after the implementation of our tool," said Dr. Morrissey. This was defined as appropriate pharmacologic prophylaxis when indicated.

They also compared pre- and post-implementation periods to assess VTE rates. At New York–Presbyterian’s Columbia University Medical Center campus, the VTE rate prior to assessment implementation was 1.08/1,000 patient-days from January through June 2010. At the same campus, the VTE rate dropped to 0.80/1,000 patient-days from July through December. Similarly, at New York–Presbyterian’s other campus, Weill Cornell Medical Center, the VTE rate was 1.19/1,000 patient-days from January through June 2010; it dropped to 0.84/1,000 patient-days from July through December 2010.

"Interestingly, what we found at both institutions was that our pulmonary embolism rate dropped significantly between the first and second half of 2010," said Dr. Morrissey. At Columbia, the number of pulmonary embolisms dropped from 24 to 15. At Cornell, the number of PEs dropped from 41 to 15.

"We saw that a significant number of patients actually suffered from upper-extremity line-associated clots," he noted. At Columbia, there were 31 upper extremity events from January to June 2010; there were 33 from July to December. At Cornell, there were 38 upper extremity events in the first half of the year and 33 in the second half.

Both institutions used the AMALGA system to provide clinicians with feedback. The software calculates the patient’s risk score in real time as patients are admitted, based on their past medical history. The software also collects all of the information entered into the electronic order set. This allows staff to look and see which patients are listed as high risk or low risk and whether the clinician used the tool appropriately. "So we’re actually able to assess hospital wide how these patients are receiving prophylaxis," said Dr. Morrissey.

The tool also allows the identification of patients that are inappropriately classified based on risk and who are receiving inappropriate prophylaxis. "We can reach out to those clinicians in real time and discuss with them the issues related to prophylaxis."

With further validation, the system could prove a considerable asset in meeting and demonstrating quality goals, he noted.

The authors reported that they have no relevant disclosures.