Damian McNamara

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

Medical records can be a practical tool in hospitals’ quest to lower patients’ risk of 30-day readmission, says the lead researcher of one study aimed at identifying patients most in need of transitional care interventions and another designed to define a limited number interventions based on a patient's identified risks and needs.

In the first study, Angie Hochhalter, Ph.D., and her associates found that longer length of stay, major or extreme illness severity, and unscheduled admission were each significantly associated with a higher risk for 30-day hospital readmission. The assessed records for 6,287 Medicare beneficiaries hospitalized for at least 1 day in 2008 in Texas, noting that the 13.5% 30-day readmission rate was better than Medicare average.

"It’s nice that we have some things that come out as significant, but it is not helpful if we are looking to do personalized transitions," said Dr. Hochhalter, a member of the internal medicine faculty at Scott & White Healthcare and Texas A&M Health Science Center, both in Temple, Texas. So, she said, to determine how people’s behavior might play a role, "we used medication adherence in study No. 2."

In that investigation, the team evaluated data for 2,816 older patients at Scott & White Memorial Hospital. Patients were 65 years and older (median age 77 years) and had a 9.2% 30-day readmission rate at 30 days. They identified two significant factors: readmission was less likely for patients discharged to home vs. a nursing home (hazard ratio, 0.58) or who were more adherent to medications (HR, 0.065).

Empirical evidence is needed to address the problem of readmissions among older hospitalized patients, Dr. Hochhalter said. A high amount of patient heterogeneity is a challenge to designing effective, patient-directed transitional care interventions, she said.

"It’s a Cinderella problem – one size fits few. There are evidence-based interventions we can use, but to pick one and use [it] as a hospital system is probably not going to reach everyone" said Dr. Hochhalter at the most-recent annual meeting of the Gerontological Society of America.

"Offering many sizes is impractical," Dr. Hochhalter said. So her aim was to identify a limited number of transitional care interventions, based on identified risks and needs. The three main drivers of this personalized approach would be predetermined risk, clinical judgment, and family choice.

Scott & White has an integrated electronic record system that includes health plan billing, claims, clinical data, information on use of services, and more, she said. The first study data included members of a Medicare cost contract offered by Scott & White Health Plan. The 6,287 beneficiaries were hospitalized for at least 1 day in 2008, were discharged, and had a subsequent contact with Scott & White within 1 year. The 180-day readmission rate approached 35%.

"The DRG [diagnosis-related groups] severity score gives you an idea of how serious their condition was," Dr. Hochhalter said. Not surprisingly, the 30-day readmission rate increased with severity of illness. "This is important when we think about who we want to target with interventions."

The specific increased risks of 30-day readmission were longer length-of-stay (HR, 1.01), major or extreme severity of illness (HR, 1.61), and unscheduled admission (HR, 1.59).

The results of the second study suggest a person’s behavior, specifically medication adherence, can lower readmission rates. The investigators used medication possession ratio (MPR) from July 2006 to June 2008 as an indirect measure of adherence. "It is more a measure of behavior in the long term and [also reflects their] engagement in their own health," Dr. Hochhalter said. Data included patients hospitalized for at least 1 day at Scott & White in 2007 and then discharged. The 180-day readmission rate in this study was nearly 31%, she added.

They assessed the MPRs for overall drug use, as well as medications used to combat diabetes, hyperlipidemia, hypertension, and depression. "Adherence rates to disease-specific medications were high. We consider anything over 80% high," Dr. Hochhalter said. "But, in terms of overall adherence, it was moderate."

Both discharge to home (vs. a nursing home transition) and higher adherence to medication were significantly associated with lower readmission rates, Dr. Hochhalter said. Regarding adherence, she added, "It is good to show this long-term behavior [is beneficial]."

Unexpectedly, seeing a physician within 30 days of discharge was associated with a higher likelihood of readmission. "It is interesting, because it’s in the wrong direction," Dr. Hochhalter said. "We’ve struggled with this—is it an overall utilization pattern or sicker people? We don’t know the explanation, but it’s unusual to find that."

ORLANDO – An endometrial echo complex thinner than 5 mm on ultrasound during initial evaluation does not necessarily rule out malignancy, according to a retrospective study of 250 postmenopausal women with biopsy-confirmed endometrial cancer.

The American College of Obstetricians and Gynecologists currently recommends no further diagnostic procedures in a woman with postmenopausal bleeding and an endometrial echo complex (EEC) less than or equal to 4 mm because the risk of malignancy is low. The committee opinion cited a number of reports comparing transvaginal ultrasonography with endometrial sampling that consistently found that an endometrial thickness of less than or equal to 4-5 mm in patients with postmenopausal bleeding reliably excluded endometrial cancer (ACOG Committee Opinion 440, August 2009).

"Although an EEC less than 5 mm may be reassuring, it does not rule out endometrial cancer and cannot supplant definitive histologic evaluation," Dr. Uma Chandavarkar said at the annual meeting of the Society of Gynecologic Oncologists.

A total of 40% of the 250 women had an EEC less than 5 mm in the study, regardless of histology type, said Dr. Chandavarkar, a fellow in gynecologic oncology at the University of Southern California in Los Angeles.

Interestingly, a greater percentage of patients with the more-aggressive type II endometrial cancers had an endometrial stripe less than 5 mm, 46% of 162 women, compared with 29% of 88 patients with type I disease. This was a statistically significant difference.

"Transvaginal ultrasound cannot replace definitive histologic evaluation," Dr. Chandavarkar said. "We recommend these patients are counseled that endometrial cancer may be missed without a biopsy."

"Some of the best studies you can do are often the simplest ones, and this study fits the criteria," said invited study discussant Dr. Richard Barakat, chair of gynecologic surgery at Memorial Sloan-Kettering Cancer Center, New York.

"It is important to do studies like this," Dr. Barakat continued, because "others have said women who are bleeding with an endometrial stripe less than 4 mm do not need an endometrial biopsy."

In the current study, radiologists performed the preoperative, pelvic ultrasound examination 3 months or less prior to hysterectomy with biopsy evaluation. They found no statistically significant differences by histology classification for ancillary ultrasound characteristics, including adnexal masses, myomatous masses, or free pelvic fluid.

Patients were treated from 1999 to 2009 at the University of Southern California/Los Angeles County Medical Center and the USC Norris Cancer Center. Patient demographics and clinical factors did not differ significantly by histology type. For example, mean patient age at time of endometrial cancer diagnosis was 59 years for type I cancer vs. 60 years for type II; mean age of menopause was 50 years and 51 years, respectively; and mean body mass index was 32 kg/m² and 31 kg/m², respectively. There likewise were no significant differences in gravidity, parity, race, or use of hormone therapy between groups. One exception was a significantly longer duration of hormone therapy among women diagnosed with type II vs. type I endometrial cancer, Dr. Chandavarkar said.

The cutoff for concern remains controversial.

A recent meta-analysis suggests the cutoff to rule out endometrial cancer should be 3 mm or less for women with postmenopausal bleeding (Obstet. Gynecol. 2010;116;160-7). However, their analytical methods were criticized in an editorial by Dr. Linda R. Duska, a gynecologic oncologist at the University of Virginia Health System in Charlottesville. Dr. Duska said the preponderance of data still supports an endometrial stripe thicker than 4 mm for endometrial biopsy sampling.

Automatic sampling of the endometrium should be discouraged, Dr. Steven Goldstein said in a review article (Obstet. Gynecol. 2010;116:168-76), citing an "extremely high" 10%-17% rate of incidental thick EEC findings in women without postmenopausal bleeding. Dr. Goldstein is professor of obstetrics and gynecology at New York University Medical Center.

In the current study, a relatively large patient cohort and the close timing of the ultrasound examination and biopsy were strengths of the study, Dr. Barakat said. In addition, correlation between EEC and type of endometrial cancer was another plus.

A retrospective design, EEC thickness data extracted from ultrasound reports over 10 years, and the criteria used to distinguish type 1 from type 2 cancers are potential limitations, he said.

Dr. Chandavarkar and Dr. Barakat said that they had no relevant financial disclosures.

ORLANDO – An endometrial echo complex thinner than 5 mm on ultrasound during initial evaluation does not necessarily rule out malignancy, according to a retrospective study of 250 postmenopausal women with biopsy-confirmed endometrial cancer.

The American College of Obstetricians and Gynecologists currently recommends no further diagnostic procedures in a woman with postmenopausal bleeding and an endometrial echo complex (EEC) less than or equal to 4 mm because the risk of malignancy is low. The committee opinion cited a number of reports comparing transvaginal ultrasonography with endometrial sampling that consistently found that an endometrial thickness of less than or equal to 4-5 mm in patients with postmenopausal bleeding reliably excluded endometrial cancer (ACOG Committee Opinion 440, August 2009).

"Although an EEC less than 5 mm may be reassuring, it does not rule out endometrial cancer and cannot supplant definitive histologic evaluation," Dr. Uma Chandavarkar said at the annual meeting of the Society of Gynecologic Oncologists.

A total of 40% of the 250 women had an EEC less than 5 mm in the study, regardless of histology type, said Dr. Chandavarkar, a fellow in gynecologic oncology at the University of Southern California in Los Angeles.

Interestingly, a greater percentage of patients with the more-aggressive type II endometrial cancers had an endometrial stripe less than 5 mm, 46% of 162 women, compared with 29% of 88 patients with type I disease. This was a statistically significant difference.

"Transvaginal ultrasound cannot replace definitive histologic evaluation," Dr. Chandavarkar said. "We recommend these patients are counseled that endometrial cancer may be missed without a biopsy."

"Some of the best studies you can do are often the simplest ones, and this study fits the criteria," said invited study discussant Dr. Richard Barakat, chair of gynecologic surgery at Memorial Sloan-Kettering Cancer Center, New York.

"It is important to do studies like this," Dr. Barakat continued, because "others have said women who are bleeding with an endometrial stripe less than 4 mm do not need an endometrial biopsy."

In the current study, radiologists performed the preoperative, pelvic ultrasound examination 3 months or less prior to hysterectomy with biopsy evaluation. They found no statistically significant differences by histology classification for ancillary ultrasound characteristics, including adnexal masses, myomatous masses, or free pelvic fluid.

Patients were treated from 1999 to 2009 at the University of Southern California/Los Angeles County Medical Center and the USC Norris Cancer Center. Patient demographics and clinical factors did not differ significantly by histology type. For example, mean patient age at time of endometrial cancer diagnosis was 59 years for type I cancer vs. 60 years for type II; mean age of menopause was 50 years and 51 years, respectively; and mean body mass index was 32 kg/m² and 31 kg/m², respectively. There likewise were no significant differences in gravidity, parity, race, or use of hormone therapy between groups. One exception was a significantly longer duration of hormone therapy among women diagnosed with type II vs. type I endometrial cancer, Dr. Chandavarkar said.

The cutoff for concern remains controversial.

A recent meta-analysis suggests the cutoff to rule out endometrial cancer should be 3 mm or less for women with postmenopausal bleeding (Obstet. Gynecol. 2010;116;160-7). However, their analytical methods were criticized in an editorial by Dr. Linda R. Duska, a gynecologic oncologist at the University of Virginia Health System in Charlottesville. Dr. Duska said the preponderance of data still supports an endometrial stripe thicker than 4 mm for endometrial biopsy sampling.

Automatic sampling of the endometrium should be discouraged, Dr. Steven Goldstein said in a review article (Obstet. Gynecol. 2010;116:168-76), citing an "extremely high" 10%-17% rate of incidental thick EEC findings in women without postmenopausal bleeding. Dr. Goldstein is professor of obstetrics and gynecology at New York University Medical Center.

In the current study, a relatively large patient cohort and the close timing of the ultrasound examination and biopsy were strengths of the study, Dr. Barakat said. In addition, correlation between EEC and type of endometrial cancer was another plus.

A retrospective design, EEC thickness data extracted from ultrasound reports over 10 years, and the criteria used to distinguish type 1 from type 2 cancers are potential limitations, he said.

Dr. Chandavarkar and Dr. Barakat said that they had no relevant financial disclosures.

ORLANDO – An endometrial echo complex thinner than 5 mm on ultrasound during initial evaluation does not necessarily rule out malignancy, according to a retrospective study of 250 postmenopausal women with biopsy-confirmed endometrial cancer.

The American College of Obstetricians and Gynecologists currently recommends no further diagnostic procedures in a woman with postmenopausal bleeding and an endometrial echo complex (EEC) less than or equal to 4 mm because the risk of malignancy is low. The committee opinion cited a number of reports comparing transvaginal ultrasonography with endometrial sampling that consistently found that an endometrial thickness of less than or equal to 4-5 mm in patients with postmenopausal bleeding reliably excluded endometrial cancer (ACOG Committee Opinion 440, August 2009).

"Although an EEC less than 5 mm may be reassuring, it does not rule out endometrial cancer and cannot supplant definitive histologic evaluation," Dr. Uma Chandavarkar said at the annual meeting of the Society of Gynecologic Oncologists.

A total of 40% of the 250 women had an EEC less than 5 mm in the study, regardless of histology type, said Dr. Chandavarkar, a fellow in gynecologic oncology at the University of Southern California in Los Angeles.

Interestingly, a greater percentage of patients with the more-aggressive type II endometrial cancers had an endometrial stripe less than 5 mm, 46% of 162 women, compared with 29% of 88 patients with type I disease. This was a statistically significant difference.

"Transvaginal ultrasound cannot replace definitive histologic evaluation," Dr. Chandavarkar said. "We recommend these patients are counseled that endometrial cancer may be missed without a biopsy."

"Some of the best studies you can do are often the simplest ones, and this study fits the criteria," said invited study discussant Dr. Richard Barakat, chair of gynecologic surgery at Memorial Sloan-Kettering Cancer Center, New York.

"It is important to do studies like this," Dr. Barakat continued, because "others have said women who are bleeding with an endometrial stripe less than 4 mm do not need an endometrial biopsy."

In the current study, radiologists performed the preoperative, pelvic ultrasound examination 3 months or less prior to hysterectomy with biopsy evaluation. They found no statistically significant differences by histology classification for ancillary ultrasound characteristics, including adnexal masses, myomatous masses, or free pelvic fluid.

Patients were treated from 1999 to 2009 at the University of Southern California/Los Angeles County Medical Center and the USC Norris Cancer Center. Patient demographics and clinical factors did not differ significantly by histology type. For example, mean patient age at time of endometrial cancer diagnosis was 59 years for type I cancer vs. 60 years for type II; mean age of menopause was 50 years and 51 years, respectively; and mean body mass index was 32 kg/m² and 31 kg/m², respectively. There likewise were no significant differences in gravidity, parity, race, or use of hormone therapy between groups. One exception was a significantly longer duration of hormone therapy among women diagnosed with type II vs. type I endometrial cancer, Dr. Chandavarkar said.

The cutoff for concern remains controversial.

A recent meta-analysis suggests the cutoff to rule out endometrial cancer should be 3 mm or less for women with postmenopausal bleeding (Obstet. Gynecol. 2010;116;160-7). However, their analytical methods were criticized in an editorial by Dr. Linda R. Duska, a gynecologic oncologist at the University of Virginia Health System in Charlottesville. Dr. Duska said the preponderance of data still supports an endometrial stripe thicker than 4 mm for endometrial biopsy sampling.

Automatic sampling of the endometrium should be discouraged, Dr. Steven Goldstein said in a review article (Obstet. Gynecol. 2010;116:168-76), citing an "extremely high" 10%-17% rate of incidental thick EEC findings in women without postmenopausal bleeding. Dr. Goldstein is professor of obstetrics and gynecology at New York University Medical Center.

In the current study, a relatively large patient cohort and the close timing of the ultrasound examination and biopsy were strengths of the study, Dr. Barakat said. In addition, correlation between EEC and type of endometrial cancer was another plus.

A retrospective design, EEC thickness data extracted from ultrasound reports over 10 years, and the criteria used to distinguish type 1 from type 2 cancers are potential limitations, he said.

Dr. Chandavarkar and Dr. Barakat said that they had no relevant financial disclosures.

ORLANDO – An endometrial echo complex thinner than 5 mm on ultrasound during initial evaluation does not necessarily rule out malignancy, according to a retrospective study of 250 postmenopausal women with biopsy-confirmed endometrial cancer.

The American College of Obstetricians and Gynecologists currently recommends no further diagnostic procedures in a woman with postmenopausal bleeding and an endometrial echo complex (EEC) less than or equal to 4 mm because the risk of malignancy is low. The committee opinion cited a number of reports comparing transvaginal ultrasonography with endometrial sampling that consistently found that an endometrial thickness of less than or equal to 4-5 mm in patients with postmenopausal bleeding reliably excluded endometrial cancer (ACOG Committee Opinion 440, August 2009).

"Although an EEC less than 5 mm may be reassuring, it does not rule out endometrial cancer and cannot supplant definitive histologic evaluation," Dr. Uma Chandavarkar said at the annual meeting of the Society of Gynecologic Oncologists.

A total of 40% of the 250 women had an EEC less than 5 mm in the study, regardless of histology type, said Dr. Chandavarkar, a fellow in gynecologic oncology at the University of Southern California in Los Angeles.

Interestingly, a greater percentage of patients with the more-aggressive type II endometrial cancers had an endometrial stripe less than 5 mm, 46% of 162 women, compared with 29% of 88 patients with type I disease. This was a statistically significant difference.

"Transvaginal ultrasound cannot replace definitive histologic evaluation," Dr. Chandavarkar said. "We recommend these patients are counseled that endometrial cancer may be missed without a biopsy."

"Some of the best studies you can do are often the simplest ones, and this study fits the criteria," said invited study discussant Dr. Richard Barakat, chair of gynecologic surgery at Memorial Sloan-Kettering Cancer Center, New York.

"It is important to do studies like this," Dr. Barakat continued, because "others have said women who are bleeding with an endometrial stripe less than 4 mm do not need an endometrial biopsy."

In the current study, radiologists performed the preoperative, pelvic ultrasound examination 3 months or less prior to hysterectomy with biopsy evaluation. They found no statistically significant differences by histology classification for ancillary ultrasound characteristics, including adnexal masses, myomatous masses, or free pelvic fluid.

Patients were treated from 1999 to 2009 at the University of Southern California/Los Angeles County Medical Center and the USC Norris Cancer Center. Patient demographics and clinical factors did not differ significantly by histology type. For example, mean patient age at time of endometrial cancer diagnosis was 59 years for type I cancer vs. 60 years for type II; mean age of menopause was 50 years and 51 years, respectively; and mean body mass index was 32 kg/m² and 31 kg/m², respectively. There likewise were no significant differences in gravidity, parity, race, or use of hormone therapy between groups. One exception was a significantly longer duration of hormone therapy among women diagnosed with type II vs. type I endometrial cancer, Dr. Chandavarkar said.

The cutoff for concern remains controversial.

A recent meta-analysis suggests the cutoff to rule out endometrial cancer should be 3 mm or less for women with postmenopausal bleeding (Obstet. Gynecol. 2010;116;160-7). However, their analytical methods were criticized in an editorial by Dr. Linda R. Duska, a gynecologic oncologist at the University of Virginia Health System in Charlottesville. Dr. Duska said the preponderance of data still supports an endometrial stripe thicker than 4 mm for endometrial biopsy sampling.

Automatic sampling of the endometrium should be discouraged, Dr. Steven Goldstein said in a review article (Obstet. Gynecol. 2010;116:168-76), citing an "extremely high" 10%-17% rate of incidental thick EEC findings in women without postmenopausal bleeding. Dr. Goldstein is professor of obstetrics and gynecology at New York University Medical Center.

In the current study, a relatively large patient cohort and the close timing of the ultrasound examination and biopsy were strengths of the study, Dr. Barakat said. In addition, correlation between EEC and type of endometrial cancer was another plus.

A retrospective design, EEC thickness data extracted from ultrasound reports over 10 years, and the criteria used to distinguish type 1 from type 2 cancers are potential limitations, he said.

Dr. Chandavarkar and Dr. Barakat said that they had no relevant financial disclosures.

ORLANDO – An endometrial echo complex thinner than 5 mm on ultrasound during initial evaluation does not necessarily rule out malignancy, according to a retrospective study of 250 postmenopausal women with biopsy-confirmed endometrial cancer.

The American College of Obstetricians and Gynecologists currently recommends no further diagnostic procedures in a woman with postmenopausal bleeding and an endometrial echo complex (EEC) less than or equal to 4 mm because the risk of malignancy is low. The committee opinion cited a number of reports comparing transvaginal ultrasonography with endometrial sampling that consistently found that an endometrial thickness of less than or equal to 4-5 mm in patients with postmenopausal bleeding reliably excluded endometrial cancer (ACOG Committee Opinion 440, August 2009).

"Although an EEC less than 5 mm may be reassuring, it does not rule out endometrial cancer and cannot supplant definitive histologic evaluation," Dr. Uma Chandavarkar said at the annual meeting of the Society of Gynecologic Oncologists.

A total of 40% of the 250 women had an EEC less than 5 mm in the study, regardless of histology type, said Dr. Chandavarkar, a fellow in gynecologic oncology at the University of Southern California in Los Angeles.

Interestingly, a greater percentage of patients with the more-aggressive type II endometrial cancers had an endometrial stripe less than 5 mm, 46% of 162 women, compared with 29% of 88 patients with type I disease. This was a statistically significant difference.

"Transvaginal ultrasound cannot replace definitive histologic evaluation," Dr. Chandavarkar said. "We recommend these patients are counseled that endometrial cancer may be missed without a biopsy."

"Some of the best studies you can do are often the simplest ones, and this study fits the criteria," said invited study discussant Dr. Richard Barakat, chair of gynecologic surgery at Memorial Sloan-Kettering Cancer Center, New York.

"It is important to do studies like this," Dr. Barakat continued, because "others have said women who are bleeding with an endometrial stripe less than 4 mm do not need an endometrial biopsy."

In the current study, radiologists performed the preoperative, pelvic ultrasound examination 3 months or less prior to hysterectomy with biopsy evaluation. They found no statistically significant differences by histology classification for ancillary ultrasound characteristics, including adnexal masses, myomatous masses, or free pelvic fluid.

Patients were treated from 1999 to 2009 at the University of Southern California/Los Angeles County Medical Center and the USC Norris Cancer Center. Patient demographics and clinical factors did not differ significantly by histology type. For example, mean patient age at time of endometrial cancer diagnosis was 59 years for type I cancer vs. 60 years for type II; mean age of menopause was 50 years and 51 years, respectively; and mean body mass index was 32 kg/m² and 31 kg/m², respectively. There likewise were no significant differences in gravidity, parity, race, or use of hormone therapy between groups. One exception was a significantly longer duration of hormone therapy among women diagnosed with type II vs. type I endometrial cancer, Dr. Chandavarkar said.

The cutoff for concern remains controversial.

A recent meta-analysis suggests the cutoff to rule out endometrial cancer should be 3 mm or less for women with postmenopausal bleeding (Obstet. Gynecol. 2010;116;160-7). However, their analytical methods were criticized in an editorial by Dr. Linda R. Duska, a gynecologic oncologist at the University of Virginia Health System in Charlottesville. Dr. Duska said the preponderance of data still supports an endometrial stripe thicker than 4 mm for endometrial biopsy sampling.

Automatic sampling of the endometrium should be discouraged, Dr. Steven Goldstein said in a review article (Obstet. Gynecol. 2010;116:168-76), citing an "extremely high" 10%-17% rate of incidental thick EEC findings in women without postmenopausal bleeding. Dr. Goldstein is professor of obstetrics and gynecology at New York University Medical Center.

In the current study, a relatively large patient cohort and the close timing of the ultrasound examination and biopsy were strengths of the study, Dr. Barakat said. In addition, correlation between EEC and type of endometrial cancer was another plus.

A retrospective design, EEC thickness data extracted from ultrasound reports over 10 years, and the criteria used to distinguish type 1 from type 2 cancers are potential limitations, he said.

Dr. Chandavarkar and Dr. Barakat said that they had no relevant financial disclosures.

ORLANDO – An endometrial echo complex thinner than 5 mm on ultrasound during initial evaluation does not necessarily rule out malignancy, according to a retrospective study of 250 postmenopausal women with biopsy-confirmed endometrial cancer.

The American College of Obstetricians and Gynecologists currently recommends no further diagnostic procedures in a woman with postmenopausal bleeding and an endometrial echo complex (EEC) less than or equal to 4 mm because the risk of malignancy is low. The committee opinion cited a number of reports comparing transvaginal ultrasonography with endometrial sampling that consistently found that an endometrial thickness of less than or equal to 4-5 mm in patients with postmenopausal bleeding reliably excluded endometrial cancer (ACOG Committee Opinion 440, August 2009).

"Although an EEC less than 5 mm may be reassuring, it does not rule out endometrial cancer and cannot supplant definitive histologic evaluation," Dr. Uma Chandavarkar said at the annual meeting of the Society of Gynecologic Oncologists.

A total of 40% of the 250 women had an EEC less than 5 mm in the study, regardless of histology type, said Dr. Chandavarkar, a fellow in gynecologic oncology at the University of Southern California in Los Angeles.

Interestingly, a greater percentage of patients with the more-aggressive type II endometrial cancers had an endometrial stripe less than 5 mm, 46% of 162 women, compared with 29% of 88 patients with type I disease. This was a statistically significant difference.

"Transvaginal ultrasound cannot replace definitive histologic evaluation," Dr. Chandavarkar said. "We recommend these patients are counseled that endometrial cancer may be missed without a biopsy."

"Some of the best studies you can do are often the simplest ones, and this study fits the criteria," said invited study discussant Dr. Richard Barakat, chair of gynecologic surgery at Memorial Sloan-Kettering Cancer Center, New York.

"It is important to do studies like this," Dr. Barakat continued, because "others have said women who are bleeding with an endometrial stripe less than 4 mm do not need an endometrial biopsy."

In the current study, radiologists performed the preoperative, pelvic ultrasound examination 3 months or less prior to hysterectomy with biopsy evaluation. They found no statistically significant differences by histology classification for ancillary ultrasound characteristics, including adnexal masses, myomatous masses, or free pelvic fluid.

Patients were treated from 1999 to 2009 at the University of Southern California/Los Angeles County Medical Center and the USC Norris Cancer Center. Patient demographics and clinical factors did not differ significantly by histology type. For example, mean patient age at time of endometrial cancer diagnosis was 59 years for type I cancer vs. 60 years for type II; mean age of menopause was 50 years and 51 years, respectively; and mean body mass index was 32 kg/m² and 31 kg/m², respectively. There likewise were no significant differences in gravidity, parity, race, or use of hormone therapy between groups. One exception was a significantly longer duration of hormone therapy among women diagnosed with type II vs. type I endometrial cancer, Dr. Chandavarkar said.

The cutoff for concern remains controversial.

A recent meta-analysis suggests the cutoff to rule out endometrial cancer should be 3 mm or less for women with postmenopausal bleeding (Obstet. Gynecol. 2010;116;160-7). However, their analytical methods were criticized in an editorial by Dr. Linda R. Duska, a gynecologic oncologist at the University of Virginia Health System in Charlottesville. Dr. Duska said the preponderance of data still supports an endometrial stripe thicker than 4 mm for endometrial biopsy sampling.

Automatic sampling of the endometrium should be discouraged, Dr. Steven Goldstein said in a review article (Obstet. Gynecol. 2010;116:168-76), citing an "extremely high" 10%-17% rate of incidental thick EEC findings in women without postmenopausal bleeding. Dr. Goldstein is professor of obstetrics and gynecology at New York University Medical Center.

In the current study, a relatively large patient cohort and the close timing of the ultrasound examination and biopsy were strengths of the study, Dr. Barakat said. In addition, correlation between EEC and type of endometrial cancer was another plus.

A retrospective design, EEC thickness data extracted from ultrasound reports over 10 years, and the criteria used to distinguish type 1 from type 2 cancers are potential limitations, he said.

Dr. Chandavarkar and Dr. Barakat said that they had no relevant financial disclosures.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.

ORLANDO – Although the mean increase in body weight was "impressive," ghrelin treatment failed to improve functional outcomes for patients with cachexia associated with chronic obstructive pulmonary disease in a phase II trial.

Although this exploratory trial revealed that ghrelin use caused gains in lean muscle mass and function in COPD patients with severe cachexia, improvements in patient function were "rather disappointing," Dr. Joseph M. Gertner said at an international symposium on IGF-1, GH, and Gherlin/GHS.

Improvement in patient function was a study end point stipulated by the Food and Drug Administration for the preclinical trials of ghrelin agent SUN11031 (Asubio Pharmaceuticals).

"If the only thing you think you need to do to correct cachexia is increase body weight, then this trial worked just fine," said Dr. Gertner, vice president of medical affairs at Asubio. The study showed a 2.5-kg mean weight gain in the high-dose group (40 mcg/kg twice daily) and a 1.5-kg gain in the low-dose group (20 mcg/kg twice daily) at 12 weeks, he said.

"The secondary end point, mean change in baseline body weight, was impressive," Dr. Gertner said at the meeting, sponsored by the University of South Florida, Tampa.

The 214 patients with COPD and cachexia in the intent-to-treat analysis included 73 patients randomized to receive the low dose of ghrelin, 69 to the high dose, and 72 to placebo. Patients were aged 50 years or older (average, 65 years).

The primary end point was performance on a 6-minute walk test, which is widely used to assess physical performance in COPD. Dr. Gertner and his associates also used the short physical performance battery (SPPB), a validated measure that is predictive of morbidity and mortality. The SPPB has three components: a balance test ("no influence in our study"), a chair stand (number of times a patient can stand from a sitting position in 5 or 10 seconds), and a gait speed test (time to walk 4 m).

Handgrip strength, maximum inspiratory pressure, and changes in body weight, body composition, and appetite were also assessed.

"No evidence of strength or functional improvement was observed in the [intent-to-treat] population," Dr. Gertner said. For example, the low-dose group fared significantly worse on the 6-minute walk test than did the placebo group, and no significant improvements on the SPPB test were seen, he said.

Cachexia was defined as a body mass index of 21 kg/m² or less for men and 20 or less for women, or documented involuntary weight loss of more than 5% over 12 months.

More advanced cachexia was defined as a BMI of less than 16 for men or less than 15 for women.

Among those in the subgroup with more advanced cachexia, significant improvements on the 6-minute walk and SPPB tests were seen with high-dose ghrelin, and positive trends on these tests were found with low-dose ghrelin. In addition, "more than 80% of these very severely cachectic patients increased their lean body mass," Dr. Gertner said.

Ghrelin is a logical choice to combat cachexia, Dr. Gertner said, because "the properties of this hormone seem to line up well with pathophysiologic properties of cachexia." For example, ghrelin causes the release of growth hormone, which might counter catabolism. Ghrelin also increases appetite, improves metabolic rate (thereby improving efficiency of food conversion to body mass), and stimulates gastrointestinal motility. "With all these properties of one ligand, it is not surprising many companies have tried to use ghrelin and the ghrelin secretagogues to reverse cachexia."

Dr. Gertner and his coauthors are full-time employees of Asubio Pharmaceuticals.